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Chapter 14: completing ‘summary of findings’ tables and grading the certainty of the evidence.

Holger J Schünemann, Julian PT Higgins, Gunn E Vist, Paul Glasziou, Elie A Akl, Nicole Skoetz, Gordon H Guyatt; on behalf of the Cochrane GRADEing Methods Group (formerly Applicability and Recommendations Methods Group) and the Cochrane Statistical Methods Group

Key Points:

• A ‘Summary of findings’ table for a given comparison of interventions provides key information concerning the magnitudes of relative and absolute effects of the interventions examined, the amount of available evidence and the certainty (or quality) of available evidence.
• ‘Summary of findings’ tables include a row for each important outcome (up to a maximum of seven). Accepted formats of ‘Summary of findings’ tables and interactive ‘Summary of findings’ tables can be produced using GRADE’s software GRADEpro GDT.
• Cochrane has adopted the GRADE approach (Grading of Recommendations Assessment, Development and Evaluation) for assessing certainty (or quality) of a body of evidence.
• The GRADE approach specifies four levels of the certainty for a body of evidence for a given outcome: high, moderate, low and very low.
• GRADE assessments of certainty are determined through consideration of five domains: risk of bias, inconsistency, indirectness, imprecision and publication bias. For evidence from non-randomized studies and rarely randomized studies, assessments can then be upgraded through consideration of three further domains.

Cite this chapter as: Schünemann HJ, Higgins JPT, Vist GE, Glasziou P, Akl EA, Skoetz N, Guyatt GH. Chapter 14: Completing ‘Summary of findings’ tables and grading the certainty of the evidence. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.4 (updated August 2023). Cochrane, 2023. Available from www.training.cochrane.org/handbook .

14.1 ‘Summary of findings’ tables

14.1.1 introduction to ‘summary of findings’ tables.

‘Summary of findings’ tables present the main findings of a review in a transparent, structured and simple tabular format. In particular, they provide key information concerning the certainty or quality of evidence (i.e. the confidence or certainty in the range of an effect estimate or an association), the magnitude of effect of the interventions examined, and the sum of available data on the main outcomes. Cochrane Reviews should incorporate ‘Summary of findings’ tables during planning and publication, and should have at least one key ‘Summary of findings’ table representing the most important comparisons. Some reviews may include more than one ‘Summary of findings’ table, for example if the review addresses more than one major comparison, or includes substantially different populations that require separate tables (e.g. because the effects differ or it is important to show results separately). In the Cochrane Database of Systematic Reviews (CDSR),  all ‘Summary of findings’ tables for a review appear at the beginning, before the Background section.

14.1.2 Selecting outcomes for ‘Summary of findings’ tables

Planning for the ‘Summary of findings’ table starts early in the systematic review, with the selection of the outcomes to be included in: (i) the review; and (ii) the ‘Summary of findings’ table. This is a crucial step, and one that review authors need to address carefully.

To ensure production of optimally useful information, Cochrane Reviews begin by developing a review question and by listing all main outcomes that are important to patients and other decision makers (see Chapter 2 and Chapter 3 ). The GRADE approach to assessing the certainty of the evidence (see Section 14.2 ) defines and operationalizes a rating process that helps separate outcomes into those that are critical, important or not important for decision making. Consultation and feedback on the review protocol, including from consumers and other decision makers, can enhance this process.

Critical outcomes are likely to include clearly important endpoints; typical examples include mortality and major morbidity (such as strokes and myocardial infarction). However, they may also represent frequent minor and rare major side effects, symptoms, quality of life, burdens associated with treatment, and resource issues (costs). Burdens represent the impact of healthcare workload on patient function and well-being, and include the demands of adhering to an intervention that patients or caregivers (e.g. family) may dislike, such as having to undergo more frequent tests, or the restrictions on lifestyle that certain interventions require (Spencer-Bonilla et al 2017).

Frequently, when formulating questions that include all patient-important outcomes for decision making, review authors will confront reports of studies that have not included all these outcomes. This is particularly true for adverse outcomes. For instance, randomized trials might contribute evidence on intended effects, and on frequent, relatively minor side effects, but not report on rare adverse outcomes such as suicide attempts. Chapter 19 discusses strategies for addressing adverse effects. To obtain data for all important outcomes it may be necessary to examine the results of non-randomized studies (see Chapter 24 ). Cochrane, in collaboration with others, has developed guidance for review authors to support their decision about when to look for and include non-randomized studies (Schünemann et al 2013).

If a review includes only randomized trials, these trials may not address all important outcomes and it may therefore not be possible to address these outcomes within the constraints of the review. Review authors should acknowledge these limitations and make them transparent to readers. Review authors are encouraged to include non-randomized studies to examine rare or long-term adverse effects that may not adequately be studied in randomized trials. This raises the possibility that harm outcomes may come from studies in which participants differ from those in studies used in the analysis of benefit. Review authors will then need to consider how much such differences are likely to impact on the findings, and this will influence the certainty of evidence because of concerns about indirectness related to the population (see Section 14.2.2 ).

Non-randomized studies can provide important information not only when randomized trials do not report on an outcome or randomized trials suffer from indirectness, but also when the evidence from randomized trials is rated as very low and non-randomized studies provide evidence of higher certainty. Further discussion of these issues appears also in Chapter 24 .

14.1.3 General template for ‘Summary of findings’ tables

Several alternative standard versions of ‘Summary of findings’ tables have been developed to ensure consistency and ease of use across reviews, inclusion of the most important information needed by decision makers, and optimal presentation (see examples at Figures 14.1.a and 14.1.b ). These formats are supported by research that focused on improved understanding of the information they intend to convey (Carrasco-Labra et al 2016, Langendam et al 2016, Santesso et al 2016). They are available through GRADE’s official software package developed to support the GRADE approach: GRADEpro GDT (www.gradepro.org).

Standard Cochrane ‘Summary of findings’ tables include the following elements using one of the accepted formats. Further guidance on each of these is provided in Section 14.1.6 .

• A brief description of the population and setting addressed by the available evidence (which may be slightly different to or narrower than those defined by the review question).
• A brief description of the comparison addressed in the ‘Summary of findings’ table, including both the experimental and comparison interventions.
• A list of the most critical and/or important health outcomes, both desirable and undesirable, limited to seven or fewer outcomes.
• A measure of the typical burden of each outcomes (e.g. illustrative risk, or illustrative mean, on comparator intervention).
• The absolute and relative magnitude of effect measured for each (if both are appropriate).
• The numbers of participants and studies contributing to the analysis of each outcomes.
• A GRADE assessment of the overall certainty of the body of evidence for each outcome (which may vary by outcome).
• Space for comments.
• Explanations (formerly known as footnotes).

Ideally, ‘Summary of findings’ tables are supported by more detailed tables (known as ‘evidence profiles’) to which the review may be linked, which provide more detailed explanations. Evidence profiles include the same important health outcomes, and provide greater detail than ‘Summary of findings’ tables of both of the individual considerations feeding into the grading of certainty and of the results of the studies (Guyatt et al 2011a). They ensure that a structured approach is used to rating the certainty of evidence. Although they are rarely published in Cochrane Reviews, evidence profiles are often used, for example, by guideline developers in considering the certainty of the evidence to support guideline recommendations. Review authors will find it easier to develop the ‘Summary of findings’ table by completing the rating of the certainty of evidence in the evidence profile first in GRADEpro GDT. They can then automatically convert this to one of the ‘Summary of findings’ formats in GRADEpro GDT, including an interactive ‘Summary of findings’ for publication.

As a measure of the magnitude of effect for dichotomous outcomes, the ‘Summary of findings’ table should provide a relative measure of effect (e.g. risk ratio, odds ratio, hazard) and measures of absolute risk. For other types of data, an absolute measure alone (such as a difference in means for continuous data) might be sufficient. It is important that the magnitude of effect is presented in a meaningful way, which may require some transformation of the result of a meta-analysis (see also Chapter 15, Section 15.4 and Section 15.5 ). Reviews with more than one main comparison should include a separate ‘Summary of findings’ table for each comparison.

Figure 14.1.a provides an example of a ‘Summary of findings’ table. Figure 15.1.b  provides an alternative format that may further facilitate users’ understanding and interpretation of the review’s findings. Evidence evaluating different formats suggests that the ‘Summary of findings’ table should include a risk difference as a measure of the absolute effect and authors should preferably use a format that includes a risk difference .

A detailed description of the contents of a ‘Summary of findings’ table appears in Section 14.1.6 .

Figure 14.1.a Example of a ‘Summary of findings’ table

Summary of findings (for interactive version click here )

a All the stockings in the nine studies included in this review were below-knee compression stockings. In four studies the compression strength was 20 mmHg to 30 mmHg at the ankle. It was 10 mmHg to 20 mmHg in the other four studies. Stockings come in different sizes. If a stocking is too tight around the knee it can prevent essential venous return causing the blood to pool around the knee. Compression stockings should be fitted properly. A stocking that is too tight could cut into the skin on a long flight and potentially cause ulceration and increased risk of DVT. Some stockings can be slightly thicker than normal leg covering and can be potentially restrictive with tight foot wear. It is a good idea to wear stockings around the house prior to travel to ensure a good, comfortable fit. Participants put their stockings on two to three hours before the flight in most of the studies. The availability and cost of stockings can vary.

b Two studies recruited high risk participants defined as those with previous episodes of DVT, coagulation disorders, severe obesity, limited mobility due to bone or joint problems, neoplastic disease within the previous two years, large varicose veins or, in one of the studies, participants taller than 190 cm and heavier than 90 kg. The incidence for the seven studies that excluded high risk participants was 1.45% and the incidence for the two studies that recruited high-risk participants (with at least one risk factor) was 2.43%. We have used 10 and 30 per 1000 to express different risk strata, respectively.

c The confidence interval crosses no difference and does not rule out a small increase.

d The measurement of oedema was not validated (indirectness of the outcome) or blinded to the intervention (risk of bias).

e If there are very few or no events and the number of participants is large, judgement about the certainty of evidence (particularly judgements about imprecision) may be based on the absolute effect. Here the certainty rating may be considered ‘high’ if the outcome was appropriately assessed and the event, in fact, did not occur in 2821 studied participants.

f None of the other studies reported adverse effects, apart from four cases of superficial vein thrombosis in varicose veins in the knee region that were compressed by the upper edge of the stocking in one study.

Figure 14.1.b Example of alternative ‘Summary of findings’ table

14.1.4 Producing ‘Summary of findings’ tables

The GRADE Working Group’s software, GRADEpro GDT ( www.gradepro.org ), including GRADE’s interactive handbook, is available to assist review authors in the preparation of ‘Summary of findings’ tables. GRADEpro can use data on the comparator group risk and the effect estimate (entered by the review authors or imported from files generated in RevMan) to produce the relative effects and absolute risks associated with experimental interventions. In addition, it leads the user through the process of a GRADE assessment, and produces a table that can be used as a standalone table in a review (including by direct import into software such as RevMan or integration with RevMan Web), or an interactive ‘Summary of findings’ table (see help resources in GRADEpro).

14.1.5 Statistical considerations in ‘Summary of findings’ tables

14.1.5.1 dichotomous outcomes.

‘Summary of findings’ tables should include both absolute and relative measures of effect for dichotomous outcomes. Risk ratios, odds ratios and risk differences are different ways of comparing two groups with dichotomous outcome data (see Chapter 6, Section 6.4.1 ). Furthermore, there are two distinct risk ratios, depending on which event (e.g. ‘yes’ or ‘no’) is the focus of the analysis (see Chapter 6, Section 6.4.1.5 ). In the presence of a non-zero intervention effect, any variation across studies in the comparator group risks (i.e. variation in the risk of the event occurring without the intervention of interest, for example in different populations) makes it impossible for more than one of these measures to be truly the same in every study.

It has long been assumed in epidemiology that relative measures of effect are more consistent than absolute measures of effect from one scenario to another. There is empirical evidence to support this assumption (Engels et al 2000, Deeks and Altman 2001, Furukawa et al 2002). For this reason, meta-analyses should generally use either a risk ratio or an odds ratio as a measure of effect (see Chapter 10, Section 10.4.3 ). Correspondingly, a single estimate of relative effect is likely to be a more appropriate summary than a single estimate of absolute effect. If a relative effect is indeed consistent across studies, then different comparator group risks will have different implications for absolute benefit. For instance, if the risk ratio is consistently 0.75, then the experimental intervention would reduce a comparator group risk of 80% to 60% in the intervention group (an absolute risk reduction of 20 percentage points), but would also reduce a comparator group risk of 20% to 15% in the intervention group (an absolute risk reduction of 5 percentage points).

‘Summary of findings’ tables are built around the assumption of a consistent relative effect. It is therefore important to consider the implications of this effect for different comparator group risks (these can be derived or estimated from a number of sources, see Section 14.1.6.3 ), which may require an assessment of the certainty of evidence for prognostic evidence (Spencer et al 2012, Iorio et al 2015). For any comparator group risk, it is possible to estimate a corresponding intervention group risk (i.e. the absolute risk with the intervention) from the meta-analytic risk ratio or odds ratio. Note that the numbers provided in the ‘Corresponding risk’ column are specific to the ‘risks’ in the adjacent column.

For the meta-analytic risk ratio (RR) and assumed comparator risk (ACR) the corresponding intervention risk is obtained as:

As an example, in Figure 14.1.a , the meta-analytic risk ratio for symptomless deep vein thrombosis (DVT) is RR = 0.10 (95% CI 0.04 to 0.26). Assuming a comparator risk of ACR = 10 per 1000 = 0.01, we obtain:

For the meta-analytic odds ratio (OR) and assumed comparator risk, ACR, the corresponding intervention risk is obtained as:

Upper and lower confidence limits for the corresponding intervention risk are obtained by replacing RR or OR by their upper and lower confidence limits, respectively (e.g. replacing 0.10 with 0.04, then with 0.26, in the example). Such confidence intervals do not incorporate uncertainty in the assumed comparator risks.

When dealing with risk ratios, it is critical that the same definition of ‘event’ is used as was used for the meta-analysis. For example, if the meta-analysis focused on ‘death’ (as opposed to survival) as the event, then corresponding risks in the ‘Summary of findings’ table must also refer to ‘death’.

In (rare) circumstances in which there is clear rationale to assume a consistent risk difference in the meta-analysis, in principle it is possible to present this for relevant ‘assumed risks’ and their corresponding risks, and to present the corresponding (different) relative effects for each assumed risk.

The risk difference expresses the difference between the ACR and the corresponding intervention risk (or the difference between the experimental and the comparator intervention).

For the meta-analytic risk ratio (RR) and assumed comparator risk (ACR) the corresponding risk difference is obtained as (note that risks can also be expressed using percentage or percentage points):

As an example, in Figure 14.1.b the meta-analytic risk ratio is 0.41 (95% CI 0.29 to 0.55) for diarrhoea in children less than 5 years of age. Assuming a comparator group risk of 22.3% we obtain:

For the meta-analytic odds ratio (OR) and assumed comparator risk (ACR) the absolute risk difference is obtained as (percentage points):

Upper and lower confidence limits for the absolute risk difference are obtained by re-running the calculation above while replacing RR or OR by their upper and lower confidence limits, respectively (e.g. replacing 0.41 with 0.28, then with 0.55, in the example). Such confidence intervals do not incorporate uncertainty in the assumed comparator risks.

14.1.5.2 Time-to-event outcomes

Time-to-event outcomes measure whether and when a particular event (e.g. death) occurs (van Dalen et al 2007). The impact of the experimental intervention relative to the comparison group on time-to-event outcomes is usually measured using a hazard ratio (HR) (see Chapter 6, Section 6.8.1 ).

A hazard ratio expresses a relative effect estimate. It may be used in various ways to obtain absolute risks and other interpretable quantities for a specific population. Here we describe how to re-express hazard ratios in terms of: (i) absolute risk of event-free survival within a particular period of time; (ii) absolute risk of an event within a particular period of time; and (iii) median time to the event. All methods are built on an assumption of consistent relative effects (i.e. that the hazard ratio does not vary over time).

(i) Absolute risk of event-free survival within a particular period of time Event-free survival (e.g. overall survival) is commonly reported by individual studies. To obtain absolute effects for time-to-event outcomes measured as event-free survival, the summary HR can be used in conjunction with an assumed proportion of patients who are event-free in the comparator group (Tierney et al 2007). This proportion of patients will be specific to a period of time of observation. However, it is not strictly necessary to specify this period of time. For instance, a proportion of 50% of event-free patients might apply to patients with a high event rate observed over 1 year, or to patients with a low event rate observed over 2 years.

As an example, suppose the meta-analytic hazard ratio is 0.42 (95% CI 0.25 to 0.72). Assuming a comparator group risk of event-free survival (e.g. for overall survival people being alive) at 2 years of ACR = 900 per 1000 = 0.9 we obtain:

so that that 956 per 1000 people will be alive with the experimental intervention at 2 years. The derivation of the risk should be explained in a comment or footnote.

(ii) Absolute risk of an event within a particular period of time To obtain this absolute effect, again the summary HR can be used (Tierney et al 2007):

In the example, suppose we assume a comparator group risk of events (e.g. for mortality, people being dead) at 2 years of ACR = 100 per 1000 = 0.1. We obtain:

so that that 44 per 1000 people will be dead with the experimental intervention at 2 years.

(iii) Median time to the event Instead of absolute numbers, the time to the event in the intervention and comparison groups can be expressed as median survival time in months or years. To obtain median survival time the pooled HR can be applied to an assumed median survival time in the comparator group (Tierney et al 2007):

In the example, assuming a comparator group median survival time of 80 months, we obtain:

For all three of these options for re-expressing results of time-to-event analyses, upper and lower confidence limits for the corresponding intervention risk are obtained by replacing HR by its upper and lower confidence limits, respectively (e.g. replacing 0.42 with 0.25, then with 0.72, in the example). Again, as for dichotomous outcomes, such confidence intervals do not incorporate uncertainty in the assumed comparator group risks. This is of special concern for long-term survival with a low or moderate mortality rate and a corresponding high number of censored patients (i.e. a low number of patients under risk and a high censoring rate).

14.1.6 Detailed contents of a ‘Summary of findings’ table

14.1.6.1 table title and header.

The title of each ‘Summary of findings’ table should specify the healthcare question, framed in terms of the population and making it clear exactly what comparison of interventions are made. In Figure 14.1.a , the population is people taking long aeroplane flights, the intervention is compression stockings, and the control is no compression stockings.

The first rows of each ‘Summary of findings’ table should provide the following ‘header’ information:

Patients or population This further clarifies the population (and possibly the subpopulations) of interest and ideally the magnitude of risk of the most crucial adverse outcome at which an intervention is directed. For instance, people on a long-haul flight may be at different risks for DVT; those using selective serotonin reuptake inhibitors (SSRIs) might be at different risk for side effects; while those with atrial fibrillation may be at low (< 1%), moderate (1% to 4%) or high (> 4%) yearly risk of stroke.

Setting This should state any specific characteristics of the settings of the healthcare question that might limit the applicability of the summary of findings to other settings (e.g. primary care in Europe and North America).

Intervention The experimental intervention.

Comparison The comparator intervention (including no specific intervention).

14.1.6.2 Outcomes

The rows of a ‘Summary of findings’ table should include all desirable and undesirable health outcomes (listed in order of importance) that are essential for decision making, up to a maximum of seven outcomes. If there are more outcomes in the review, review authors will need to omit the less important outcomes from the table, and the decision selecting which outcomes are critical or important to the review should be made during protocol development (see Chapter 3 ). Review authors should provide time frames for the measurement of the outcomes (e.g. 90 days or 12 months) and the type of instrument scores (e.g. ranging from 0 to 100).

Note that review authors should include the pre-specified critical and important outcomes in the table whether data are available or not. However, they should be alert to the possibility that the importance of an outcome (e.g. a serious adverse effect) may only become known after the protocol was written or the analysis was carried out, and should take appropriate actions to include these in the ‘Summary of findings’ table.

The ‘Summary of findings’ table can include effects in subgroups of the population for different comparator risks and effect sizes separately. For instance, in Figure 14.1.b effects are presented for children younger and older than 5 years separately. Review authors may also opt to produce separate ‘Summary of findings’ tables for different populations.

Review authors should include serious adverse events, but it might be possible to combine minor adverse events as a single outcome, and describe this in an explanatory footnote (note that it is not appropriate to add events together unless they are independent, that is, a participant who has experienced one adverse event has an unaffected chance of experiencing the other adverse event).

Outcomes measured at multiple time points represent a particular problem. In general, to keep the table simple, review authors should present multiple time points only for outcomes critical to decision making, where either the result or the decision made are likely to vary over time. The remainder should be presented at a common time point where possible.

Review authors can present continuous outcome measures in the ‘Summary of findings’ table and should endeavour to make these interpretable to the target audience. This requires that the units are clear and readily interpretable, for example, days of pain, or frequency of headache, and the name and scale of any measurement tools used should be stated (e.g. a Visual Analogue Scale, ranging from 0 to 100). However, many measurement instruments are not readily interpretable by non-specialist clinicians or patients, for example, points on a Beck Depression Inventory or quality of life score. For these, a more interpretable presentation might involve converting a continuous to a dichotomous outcome, such as >50% improvement (see Chapter 15, Section 15.5 ).

14.1.6.3 Best estimate of risk with comparator intervention

Review authors should provide up to three typical risks for participants receiving the comparator intervention. For dichotomous outcomes, we recommend that these be presented in the form of the number of people experiencing the event per 100 or 1000 people (natural frequency) depending on the frequency of the outcome. For continuous outcomes, this would be stated as a mean or median value of the outcome measured.

Estimated or assumed comparator intervention risks could be based on assessments of typical risks in different patient groups derived from the review itself, individual representative studies in the review, or risks derived from a systematic review of prognosis studies or other sources of evidence which may in turn require an assessment of the certainty for the prognostic evidence (Spencer et al 2012, Iorio et al 2015). Ideally, risks would reflect groups that clinicians can easily identify on the basis of their presenting features.

An explanatory footnote should specify the source or rationale for each comparator group risk, including the time period to which it corresponds where appropriate. In Figure 14.1.a , clinicians can easily differentiate individuals with risk factors for deep venous thrombosis from those without. If there is known to be little variation in baseline risk then review authors may use the median comparator group risk across studies. If typical risks are not known, an option is to choose the risk from the included studies, providing the second highest for a high and the second lowest for a low risk population.

14.1.6.4 Risk with intervention

For dichotomous outcomes, review authors should provide a corresponding absolute risk for each comparator group risk, along with a confidence interval. This absolute risk with the (experimental) intervention will usually be derived from the meta-analysis result presented in the relative effect column (see Section 14.1.6.6 ). Formulae are provided in Section 14.1.5 . Review authors should present the absolute effect in the same format as the risks with comparator intervention (see Section 14.1.6.3 ), for example as the number of people experiencing the event per 1000 people.

For continuous outcomes, a difference in means or standardized difference in means should be presented with its confidence interval. These will typically be obtained directly from a meta-analysis. Explanatory text should be used to clarify the meaning, as in Figures 14.1.a and 14.1.b .

14.1.6.5 Risk difference

For dichotomous outcomes, the risk difference can be provided using one of the ‘Summary of findings’ table formats as an additional option (see Figure 14.1.b ). This risk difference expresses the difference between the experimental and comparator intervention and will usually be derived from the meta-analysis result presented in the relative effect column (see Section 14.1.6.6 ). Formulae are provided in Section 14.1.5 . Review authors should present the risk difference in the same format as assumed and corresponding risks with comparator intervention (see Section 14.1.6.3 ); for example, as the number of people experiencing the event per 1000 people or as percentage points if the assumed and corresponding risks are expressed in percentage.

For continuous outcomes, if the ‘Summary of findings’ table includes this option, the mean difference can be presented here and the ‘corresponding risk’ column left blank (see Figure 14.1.b ).

14.1.6.6 Relative effect (95% CI)

The relative effect will typically be a risk ratio or odds ratio (or occasionally a hazard ratio) with its accompanying 95% confidence interval, obtained from a meta-analysis performed on the basis of the same effect measure. Risk ratios and odds ratios are similar when the comparator intervention risks are low and effects are small, but may differ considerably when comparator group risks increase. The meta-analysis may involve an assumption of either fixed or random effects, depending on what the review authors consider appropriate, and implying that the relative effect is either an estimate of the effect of the intervention, or an estimate of the average effect of the intervention across studies, respectively.

14.1.6.7 Number of participants (studies)

This column should include the number of participants assessed in the included studies for each outcome and the corresponding number of studies that contributed these participants.

14.1.6.8 Certainty of the evidence (GRADE)

Review authors should comment on the certainty of the evidence (also known as quality of the body of evidence or confidence in the effect estimates). Review authors should use the specific evidence grading system developed by the GRADE Working Group (Atkins et al 2004, Guyatt et al 2008, Guyatt et al 2011a), which is described in detail in Section 14.2 . The GRADE approach categorizes the certainty in a body of evidence as ‘high’, ‘moderate’, ‘low’ or ‘very low’ by outcome. This is a result of judgement, but the judgement process operates within a transparent structure. As an example, the certainty would be ‘high’ if the summary were of several randomized trials with low risk of bias, but the rating of certainty becomes lower if there are concerns about risk of bias, inconsistency, indirectness, imprecision or publication bias. Judgements other than of ‘high’ certainty should be made transparent using explanatory footnotes or the ‘Comments’ column in the ‘Summary of findings’ table (see Section 14.1.6.10 ).

14.1.6.9 Comments

The aim of the ‘Comments’ field is to help interpret the information or data identified in the row. For example, this may be on the validity of the outcome measure or the presence of variables that are associated with the magnitude of effect. Important caveats about the results should be flagged here. Not all rows will need comments, and it is best to leave a blank if there is nothing warranting a comment.

14.1.6.10 Explanations

Detailed explanations should be included as footnotes to support the judgements in the ‘Summary of findings’ table, such as the overall GRADE assessment. The explanations should describe the rationale for important aspects of the content. Table 14.1.a lists guidance for useful explanations. Explanations should be concise, informative, relevant, easy to understand and accurate. If explanations cannot be sufficiently described in footnotes, review authors should provide further details of the issues in the Results and Discussion sections of the review.

Table 14.1.a Guidance for providing useful explanations in ‘Summary of findings’ (SoF) tables. Adapted from Santesso et al (2016)

14.2 Assessing the certainty or quality of a body of evidence

14.2.1 the grade approach.

The Grades of Recommendation, Assessment, Development and Evaluation Working Group (GRADE Working Group) has developed a system for grading the certainty of evidence (Schünemann et al 2003, Atkins et al 2004, Schünemann et al 2006, Guyatt et al 2008, Guyatt et al 2011a). Over 100 organizations including the World Health Organization (WHO), the American College of Physicians, the American Society of Hematology (ASH), the Canadian Agency for Drugs and Technology in Health (CADTH) and the National Institutes of Health and Clinical Excellence (NICE) in the UK have adopted the GRADE system ( www.gradeworkinggroup.org ).

Cochrane has also formally adopted this approach, and all Cochrane Reviews should use GRADE to evaluate the certainty of evidence for important outcomes (see MECIR Box 14.2.a ).

MECIR Box 14.2.a Relevant expectations for conduct of intervention reviews

For systematic reviews, the GRADE approach defines the certainty of a body of evidence as the extent to which one can be confident that an estimate of effect or association is close to the quantity of specific interest. Assessing the certainty of a body of evidence involves consideration of within- and across-study risk of bias (limitations in study design and execution or methodological quality), inconsistency (or heterogeneity), indirectness of evidence, imprecision of the effect estimates and risk of publication bias (see Section 14.2.2 ), as well as domains that may increase our confidence in the effect estimate (as described in Section 14.2.3 ). The GRADE system entails an assessment of the certainty of a body of evidence for each individual outcome. Judgements about the domains that determine the certainty of evidence should be described in the results or discussion section and as part of the ‘Summary of findings’ table.

The GRADE approach specifies four levels of certainty ( Figure 14.2.a ). For interventions, including diagnostic and other tests that are evaluated as interventions (Schünemann et al 2008b, Schünemann et al 2008a, Balshem et al 2011, Schünemann et al 2012), the starting point for rating the certainty of evidence is categorized into two types:

• randomized trials; and
• non-randomized studies of interventions (NRSI), including observational studies (including but not limited to cohort studies, and case-control studies, cross-sectional studies, case series and case reports, although not all of these designs are usually included in Cochrane Reviews).

There are many instances in which review authors rely on information from NRSI, in particular to evaluate potential harms (see Chapter 24 ). In addition, review authors can obtain relevant data from both randomized trials and NRSI, with each type of evidence complementing the other (Schünemann et al 2013).

In GRADE, a body of evidence from randomized trials begins with a high-certainty rating while a body of evidence from NRSI begins with a low-certainty rating. The lower rating with NRSI is the result of the potential bias induced by the lack of randomization (i.e. confounding and selection bias).

However, when using the new Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool (Sterne et al 2016), an assessment tool that covers the risk of bias due to lack of randomization, all studies may start as high certainty of the evidence (Schünemann et al 2018). The approach of starting all study designs (including NRSI) as high certainty does not conflict with the initial GRADE approach of starting the rating of NRSI as low certainty evidence. This is because a body of evidence from NRSI should generally be downgraded by two levels due to the inherent risk of bias associated with the lack of randomization, namely confounding and selection bias. Not downgrading NRSI from high to low certainty needs transparent and detailed justification for what mitigates concerns about confounding and selection bias (Schünemann et al 2018). Very few examples of where not rating down by two levels is appropriate currently exist.

The highest certainty rating is a body of evidence when there are no concerns in any of the GRADE factors listed in Figure 14.2.a . Review authors often downgrade evidence to moderate, low or even very low certainty evidence, depending on the presence of the five factors in Figure 14.2.a . Usually, certainty rating will fall by one level for each factor, up to a maximum of three levels for all factors. If there are very severe problems for any one domain (e.g. when assessing risk of bias, all studies were unconcealed, unblinded and lost over 50% of their patients to follow-up), evidence may fall by two levels due to that factor alone. It is not possible to rate lower than ‘very low certainty’ evidence.

Review authors will generally grade evidence from sound non-randomized studies as low certainty, even if ROBINS-I is used. If, however, such studies yield large effects and there is no obvious bias explaining those effects, review authors may rate the evidence as moderate or – if the effect is large enough – even as high certainty ( Figure 14.2.a ). The very low certainty level is appropriate for, but is not limited to, studies with critical problems and unsystematic clinical observations (e.g. case series or case reports).

Figure 14.2.a Levels of the certainty of a body of evidence in the GRADE approach. *Upgrading criteria are usually applicable to non-randomized studies only (but exceptions exist).

14.2.2 Domains that can lead to decreasing the certainty level of a body of evidence   

We now describe in more detail the five reasons (or domains) for downgrading the certainty of a body of evidence for a specific outcome. In each case, if no reason is found for downgrading the evidence, it should be classified as 'no limitation or not serious' (not important enough to warrant downgrading). If a reason is found for downgrading the evidence, it should be classified as 'serious' (downgrading the certainty rating by one level) or 'very serious' (downgrading the certainty grade by two levels). For non-randomized studies assessed with ROBINS-I, rating down by three levels should be classified as 'extremely' serious.

(1) Risk of bias or limitations in the detailed design and implementation

Our confidence in an estimate of effect decreases if studies suffer from major limitations that are likely to result in a biased assessment of the intervention effect. For randomized trials, these methodological limitations include failure to generate a random sequence, lack of allocation sequence concealment, lack of blinding (particularly with subjective outcomes that are highly susceptible to biased assessment), a large loss to follow-up or selective reporting of outcomes. Chapter 8 provides a discussion of study-level assessments of risk of bias in the context of a Cochrane Review, and proposes an approach to assessing the risk of bias for an outcome across studies as ‘Low’ risk of bias, ‘Some concerns’ and ‘High’ risk of bias for randomized trials. Levels of ‘Low’. ‘Moderate’, ‘Serious’ and ‘Critical’ risk of bias arise for non-randomized studies assessed with ROBINS-I ( Chapter 25 ). These assessments should feed directly into this GRADE domain. In particular, ‘Low’ risk of bias would indicate ‘no limitation’; ‘Some concerns’ would indicate either ‘no limitation’ or ‘serious limitation’; and ‘High’ risk of bias would indicate either ‘serious limitation’ or ‘very serious limitation’. ‘Critical’ risk of bias on ROBINS-I would indicate extremely serious limitations in GRADE. Review authors should use their judgement to decide between alternative categories, depending on the likely magnitude of the potential biases.

Every study addressing a particular outcome will differ, to some degree, in the risk of bias. Review authors should make an overall judgement on whether the certainty of evidence for an outcome warrants downgrading on the basis of study limitations. The assessment of study limitations should apply to the studies contributing to the results in the ‘Summary of findings’ table, rather than to all studies that could potentially be included in the analysis. We have argued in Chapter 7, Section 7.6.2 , that the primary analysis should be restricted to studies at low (or low and unclear) risk of bias where possible.

Table 14.2.a presents the judgements that must be made in going from assessments of the risk of bias to judgements about study limitations for each outcome included in a ‘Summary of findings’ table. A rating of high certainty evidence can be achieved only when most evidence comes from studies that met the criteria for low risk of bias. For example, of the 22 studies addressing the impact of beta-blockers on mortality in patients with heart failure, most probably or certainly used concealed allocation of the sequence, all blinded at least some key groups and follow-up of randomized patients was almost complete (Brophy et al 2001). The certainty of evidence might be downgraded by one level when most of the evidence comes from individual studies either with a crucial limitation for one item, or with some limitations for multiple items. An example of very serious limitations, warranting downgrading by two levels, is provided by evidence on surgery versus conservative treatment in the management of patients with lumbar disc prolapse (Gibson and Waddell 2007). We are uncertain of the benefit of surgery in reducing symptoms after one year or longer, because the one study included in the analysis had inadequate concealment of the allocation sequence and the outcome was assessed using a crude rating by the surgeon without blinding.

(2) Unexplained heterogeneity or inconsistency of results

When studies yield widely differing estimates of effect (heterogeneity or variability in results), investigators should look for robust explanations for that heterogeneity. For instance, drugs may have larger relative effects in sicker populations or when given in larger doses. A detailed discussion of heterogeneity and its investigation is provided in Chapter 10, Section 10.10 and Section 10.11 . If an important modifier exists, with good evidence that important outcomes are different in different subgroups (which would ideally be pre-specified), then a separate ‘Summary of findings’ table may be considered for a separate population. For instance, a separate ‘Summary of findings’ table would be used for carotid endarterectomy in symptomatic patients with high grade stenosis (70% to 99%) in which the intervention is, in the hands of the right surgeons, beneficial, and another (if review authors considered it relevant) for asymptomatic patients with low grade stenosis (less than 30%) in which surgery appears harmful (Orrapin and Rerkasem 2017). When heterogeneity exists and affects the interpretation of results, but review authors are unable to identify a plausible explanation with the data available, the certainty of the evidence decreases.

(3) Indirectness of evidence

Two types of indirectness are relevant. First, a review comparing the effectiveness of alternative interventions (say A and B) may find that randomized trials are available, but they have compared A with placebo and B with placebo. Thus, the evidence is restricted to indirect comparisons between A and B. Where indirect comparisons are undertaken within a network meta-analysis context, GRADE for network meta-analysis should be used (see Chapter 11, Section 11.5 ).

Second, a review may find randomized trials that meet eligibility criteria but address a restricted version of the main review question in terms of population, intervention, comparator or outcomes. For example, suppose that in a review addressing an intervention for secondary prevention of coronary heart disease, most identified studies happened to be in people who also had diabetes. Then the evidence may be regarded as indirect in relation to the broader question of interest because the population is primarily related to people with diabetes. The opposite scenario can equally apply: a review addressing the effect of a preventive strategy for coronary heart disease in people with diabetes may consider studies in people without diabetes to provide relevant, albeit indirect, evidence. This would be particularly likely if investigators had conducted few if any randomized trials in the target population (e.g. people with diabetes). Other sources of indirectness may arise from interventions studied (e.g. if in all included studies a technical intervention was implemented by expert, highly trained specialists in specialist centres, then evidence on the effects of the intervention outside these centres may be indirect), comparators used (e.g. if the comparator groups received an intervention that is less effective than standard treatment in most settings) and outcomes assessed (e.g. indirectness due to surrogate outcomes when data on patient-important outcomes are not available, or when investigators seek data on quality of life but only symptoms are reported). Review authors should make judgements transparent when they believe downgrading is justified, based on differences in anticipated effects in the group of primary interest. Review authors may be aided and increase transparency of their judgements about indirectness if they use Table 14.2.b available in the GRADEpro GDT software (Schünemann et al 2013).

(4) Imprecision of results

When studies include few participants or few events, and thus have wide confidence intervals, review authors can lower their rating of the certainty of the evidence. The confidence intervals included in the ‘Summary of findings’ table will provide readers with information that allows them to make, to some extent, their own rating of precision. Review authors can use a calculation of the optimal information size (OIS) or review information size (RIS), similar to sample size calculations, to make judgements about imprecision (Guyatt et al 2011b, Schünemann 2016). The OIS or RIS is calculated on the basis of the number of participants required for an adequately powered individual study. If the 95% confidence interval excludes a risk ratio (RR) of 1.0, and the total number of events or patients exceeds the OIS criterion, precision is adequate. If the 95% CI includes appreciable benefit or harm (an RR of under 0.75 or over 1.25 is often suggested as a very rough guide) downgrading for imprecision may be appropriate even if OIS criteria are met (Guyatt et al 2011b, Schünemann 2016).

(5) High probability of publication bias

The certainty of evidence level may be downgraded if investigators fail to report studies on the basis of results (typically those that show no effect: publication bias) or outcomes (typically those that may be harmful or for which no effect was observed: selective outcome non-reporting bias). Selective reporting of outcomes from among multiple outcomes measured is assessed at the study level as part of the assessment of risk of bias (see Chapter 8, Section 8.7 ), so for the studies contributing to the outcome in the ‘Summary of findings’ table this is addressed by domain 1 above (limitations in the design and implementation). If a large number of studies included in the review do not contribute to an outcome, or if there is evidence of publication bias, the certainty of the evidence may be downgraded. Chapter 13 provides a detailed discussion of reporting biases, including publication bias, and how it may be tackled in a Cochrane Review. A prototypical situation that may elicit suspicion of publication bias is when published evidence includes a number of small studies, all of which are industry-funded (Bhandari et al 2004). For example, 14 studies of flavanoids in patients with haemorrhoids have shown apparent large benefits, but enrolled a total of only 1432 patients (i.e. each study enrolled relatively few patients) (Alonso-Coello et al 2006). The heavy involvement of sponsors in most of these studies raises questions of whether unpublished studies that suggest no benefit exist (publication bias).

A particular body of evidence can suffer from problems associated with more than one of the five factors listed here, and the greater the problems, the lower the certainty of evidence rating that should result. One could imagine a situation in which randomized trials were available, but all or virtually all of these limitations would be present, and in serious form. A very low certainty of evidence rating would result.

Table 14.2.a Further guidelines for domain 1 (of 5) in a GRADE assessment: going from assessments of risk of bias in studies to judgements about study limitations for main outcomes across studies

Table 14.2.b Judgements about indirectness by outcome (available in GRADEpro GDT)

Intervention:

Comparator:

Direct comparison:

Final judgement about indirectness across domains:

14.2.3 Domains that may lead to increasing the certainty level of a body of evidence

Although NRSI and downgraded randomized trials will generally yield a low rating for certainty of evidence, there will be unusual circumstances in which review authors could ‘upgrade’ such evidence to moderate or even high certainty ( Table 14.3.a ).

• Large effects On rare occasions when methodologically well-done observational studies yield large, consistent and precise estimates of the magnitude of an intervention effect, one may be particularly confident in the results. A large estimated effect (e.g. RR >2 or RR <0.5) in the absence of plausible confounders, or a very large effect (e.g. RR >5 or RR <0.2) in studies with no major threats to validity, might qualify for this. In these situations, while the NRSI may possibly have provided an over-estimate of the true effect, the weak study design may not explain all of the apparent observed benefit. Thus, despite reservations based on the observational study design, review authors are confident that the effect exists. The magnitude of the effect in these studies may move the assigned certainty of evidence from low to moderate (if the effect is large in the absence of other methodological limitations). For example, a meta-analysis of observational studies showed that bicycle helmets reduce the risk of head injuries in cyclists by a large margin (odds ratio (OR) 0.31, 95% CI 0.26 to 0.37) (Thompson et al 2000). This large effect, in the absence of obvious bias that could create the association, suggests a rating of moderate-certainty evidence.  Note : GRADE guidance suggests the possibility of rating up one level for a large effect if the relative effect is greater than 2.0. However, if the point estimate of the relative effect is greater than 2.0, but the confidence interval is appreciably below 2.0, then some hesitation would be appropriate in the decision to rate up for a large effect. Another situation allows inference of a strong association without a formal comparative study. Consider the question of the impact of routine colonoscopy versus no screening for colon cancer on the rate of perforation associated with colonoscopy. Here, a large series of representative patients undergoing colonoscopy may provide high certainty evidence about the risk of perforation associated with colonoscopy. When the risk of the event among patients receiving the relevant comparator is known to be near 0 (i.e. we are certain that the incidence of spontaneous colon perforation in patients not undergoing colonoscopy is extremely low), case series or cohort studies of representative patients can provide high certainty evidence of adverse effects associated with an intervention, thereby allowing us to infer a strong association from even a limited number of events.
• Dose-response The presence of a dose-response gradient may increase our confidence in the findings of observational studies and thereby enhance the assigned certainty of evidence. For example, our confidence in the result of observational studies that show an increased risk of bleeding in patients who have supratherapeutic anticoagulation levels is increased by the observation that there is a dose-response gradient between the length of time needed for blood to clot (as measured by the international normalized ratio (INR)) and an increased risk of bleeding (Levine et al 2004). A systematic review of NRSI investigating the effect of cyclooxygenase-2 inhibitors on cardiovascular events found that the summary estimate (RR) with rofecoxib was 1.33 (95% CI 1.00 to 1.79) with doses less than 25mg/d, and 2.19 (95% CI 1.64 to 2.91) with doses more than 25mg/d. Although residual confounding is likely to exist in the NRSI that address this issue, the existence of a dose-response gradient and the large apparent effect of higher doses of rofecoxib markedly increase our strength of inference that the association cannot be explained by residual confounding, and is therefore likely to be both causal and, at high levels of exposure, substantial.  Note : GRADE guidance suggests the possibility of rating up one level for a large effect if the relative effect is greater than 2.0. Here, the fact that the point estimate of the relative effect is greater than 2.0, but the confidence interval is appreciably below 2.0 might make some hesitate in the decision to rate up for a large effect
• Plausible confounding On occasion, all plausible biases from randomized or non-randomized studies may be working to under-estimate an apparent intervention effect. For example, if only sicker patients receive an experimental intervention or exposure, yet they still fare better, it is likely that the actual intervention or exposure effect is larger than the data suggest. For instance, a rigorous systematic review of observational studies including a total of 38 million patients demonstrated higher death rates in private for-profit versus private not-for-profit hospitals (Devereaux et al 2002). One possible bias relates to different disease severity in patients in the two hospital types. It is likely, however, that patients in the not-for-profit hospitals were sicker than those in the for-profit hospitals. Thus, to the extent that residual confounding existed, it would bias results against the not-for-profit hospitals. The second likely bias was the possibility that higher numbers of patients with excellent private insurance coverage could lead to a hospital having more resources and a spill-over effect that would benefit those without such coverage. Since for-profit hospitals are likely to admit a larger proportion of such well-insured patients than not-for-profit hospitals, the bias is once again against the not-for-profit hospitals. Since the plausible biases would all diminish the demonstrated intervention effect, one might consider the evidence from these observational studies as moderate rather than low certainty. A parallel situation exists when observational studies have failed to demonstrate an association, but all plausible biases would have increased an intervention effect. This situation will usually arise in the exploration of apparent harmful effects. For example, because the hypoglycaemic drug phenformin causes lactic acidosis, the related agent metformin was under suspicion for the same toxicity. Nevertheless, very large observational studies have failed to demonstrate an association (Salpeter et al 2007). Given the likelihood that clinicians would be more alert to lactic acidosis in the presence of the agent and over-report its occurrence, one might consider this moderate, or even high certainty, evidence refuting a causal relationship between typical therapeutic doses of metformin and lactic acidosis.

14.3 Describing the assessment of the certainty of a body of evidence using the GRADE framework

Review authors should report the grading of the certainty of evidence in the Results section for each outcome for which this has been performed, providing the rationale for downgrading or upgrading the evidence, and referring to the ‘Summary of findings’ table where applicable.

Table 14.3.a provides a framework and examples for how review authors can justify their judgements about the certainty of evidence in each domain. These justifications should also be included in explanatory notes to the ‘Summary of Findings’ table (see Section 14.1.6.10 ).

Chapter 15, Section 15.6 , describes in more detail how the overall GRADE assessment across all domains can be used to draw conclusions about the effects of the intervention, as well as providing implications for future research.

Table 14.3.a Framework for describing the certainty of evidence and justifying downgrading or upgrading

14.4 Chapter information

Authors: Holger J Schünemann, Julian PT Higgins, Gunn E Vist, Paul Glasziou, Elie A Akl, Nicole Skoetz, Gordon H Guyatt; on behalf of the Cochrane GRADEing Methods Group (formerly Applicability and Recommendations Methods Group) and the Cochrane Statistical Methods Group

Acknowledgements: Andrew D Oxman contributed to earlier versions. Professor Penny Hawe contributed to the text on adverse effects in earlier versions. Jon Deeks provided helpful contributions on an earlier version of this chapter. For details of previous authors and editors of the Handbook , please refer to the Preface.

Funding: This work was in part supported by funding from the Michael G DeGroote Cochrane Canada Centre and the Ontario Ministry of Health.

14.5 References

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Bhandari M, Busse JW, Jackowski D, Montori VM, Schünemann H, Sprague S, Mears D, Schemitsch EH, Heels-Ansdell D, Devereaux PJ. Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. Canadian Medical Association Journal 2004; 170 : 477-480.

Brophy JM, Joseph L, Rouleau JL. Beta-blockers in congestive heart failure. A Bayesian meta-analysis. Annals of Internal Medicine 2001; 134 : 550-560.

Carrasco-Labra A, Brignardello-Petersen R, Santesso N, Neumann I, Mustafa RA, Mbuagbaw L, Etxeandia Ikobaltzeta I, De Stio C, McCullagh LJ, Alonso-Coello P, Meerpohl JJ, Vandvik PO, Brozek JL, Akl EA, Bossuyt P, Churchill R, Glenton C, Rosenbaum S, Tugwell P, Welch V, Garner P, Guyatt G, Schünemann HJ. Improving GRADE evidence tables part 1: a randomized trial shows improved understanding of content in summary of findings tables with a new format. Journal of Clinical Epidemiology 2016; 74 : 7-18.

Deeks JJ, Altman DG. Effect measures for meta-analysis of trials with binary outcomes. In: Egger M, Davey Smith G, Altman DG, editors. Systematic Reviews in Health Care: Meta-analysis in Context . 2nd ed. London (UK): BMJ Publication Group; 2001. p. 313-335.

Devereaux PJ, Choi PT, Lacchetti C, Weaver B, Schünemann HJ, Haines T, Lavis JN, Grant BJ, Haslam DR, Bhandari M, Sullivan T, Cook DJ, Walter SD, Meade M, Khan H, Bhatnagar N, Guyatt GH. A systematic review and meta-analysis of studies comparing mortality rates of private for-profit and private not-for-profit hospitals. Canadian Medical Association Journal 2002; 166 : 1399-1406.

Engels EA, Schmid CH, Terrin N, Olkin I, Lau J. Heterogeneity and statistical significance in meta-analysis: an empirical study of 125 meta-analyses. Statistics in Medicine 2000; 19 : 1707-1728.

Furukawa TA, Guyatt GH, Griffith LE. Can we individualize the 'number needed to treat'? An empirical study of summary effect measures in meta-analyses. International Journal of Epidemiology 2002; 31 : 72-76.

Gibson JN, Waddell G. Surgical interventions for lumbar disc prolapse: updated Cochrane Review. Spine 2007; 32 : 1735-1747.

Guyatt G, Oxman A, Vist G, Kunz R, Falck-Ytter Y, Alonso-Coello P, Schünemann H. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008; 336 : 3.

Guyatt G, Oxman AD, Akl EA, Kunz R, Vist G, Brozek J, Norris S, Falck-Ytter Y, Glasziou P, DeBeer H, Jaeschke R, Rind D, Meerpohl J, Dahm P, Schünemann HJ. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. Journal of Clinical Epidemiology 2011a; 64 : 383-394.

Guyatt GH, Oxman AD, Kunz R, Brozek J, Alonso-Coello P, Rind D, Devereaux PJ, Montori VM, Freyschuss B, Vist G, Jaeschke R, Williams JW, Jr., Murad MH, Sinclair D, Falck-Ytter Y, Meerpohl J, Whittington C, Thorlund K, Andrews J, Schünemann HJ. GRADE guidelines 6. Rating the quality of evidence--imprecision. Journal of Clinical Epidemiology 2011b; 64 : 1283-1293.

Iorio A, Spencer FA, Falavigna M, Alba C, Lang E, Burnand B, McGinn T, Hayden J, Williams K, Shea B, Wolff R, Kujpers T, Perel P, Vandvik PO, Glasziou P, Schünemann H, Guyatt G. Use of GRADE for assessment of evidence about prognosis: rating confidence in estimates of event rates in broad categories of patients. BMJ 2015; 350 : h870.

Langendam M, Carrasco-Labra A, Santesso N, Mustafa RA, Brignardello-Petersen R, Ventresca M, Heus P, Lasserson T, Moustgaard R, Brozek J, Schünemann HJ. Improving GRADE evidence tables part 2: a systematic survey of explanatory notes shows more guidance is needed. Journal of Clinical Epidemiology 2016; 74 : 19-27.

Levine MN, Raskob G, Landefeld S, Kearon C, Schulman S. Hemorrhagic complications of anticoagulant treatment: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126 : 287S-310S.

Orrapin S, Rerkasem K. Carotid endarterectomy for symptomatic carotid stenosis. Cochrane Database of Systematic Reviews 2017; 6 : CD001081.

Salpeter S, Greyber E, Pasternak G, Salpeter E. Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus. Cochrane Database of Systematic Reviews 2007; 4 : CD002967.

Santesso N, Carrasco-Labra A, Langendam M, Brignardello-Petersen R, Mustafa RA, Heus P, Lasserson T, Opiyo N, Kunnamo I, Sinclair D, Garner P, Treweek S, Tovey D, Akl EA, Tugwell P, Brozek JL, Guyatt G, Schünemann HJ. Improving GRADE evidence tables part 3: detailed guidance for explanatory footnotes supports creating and understanding GRADE certainty in the evidence judgments. Journal of Clinical Epidemiology 2016; 74 : 28-39.

Schünemann HJ, Best D, Vist G, Oxman AD, Group GW. Letters, numbers, symbols and words: how to communicate grades of evidence and recommendations. Canadian Medical Association Journal 2003; 169 : 677-680.

Schünemann HJ, Jaeschke R, Cook DJ, Bria WF, El-Solh AA, Ernst A, Fahy BF, Gould MK, Horan KL, Krishnan JA, Manthous CA, Maurer JR, McNicholas WT, Oxman AD, Rubenfeld G, Turino GM, Guyatt G. An official ATS statement: grading the quality of evidence and strength of recommendations in ATS guidelines and recommendations. American Journal of Respiratory and Critical Care Medicine 2006; 174 : 605-614.

Schünemann HJ, Oxman AD, Brozek J, Glasziou P, Jaeschke R, Vist GE, Williams JW, Jr., Kunz R, Craig J, Montori VM, Bossuyt P, Guyatt GH. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ 2008a; 336 : 1106-1110.

Schünemann HJ, Oxman AD, Brozek J, Glasziou P, Bossuyt P, Chang S, Muti P, Jaeschke R, Guyatt GH. GRADE: assessing the quality of evidence for diagnostic recommendations. ACP Journal Club 2008b; 149 : 2.

Schünemann HJ, Mustafa R, Brozek J. [Diagnostic accuracy and linked evidence--testing the chain]. Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen 2012; 106 : 153-160.

Schünemann HJ, Tugwell P, Reeves BC, Akl EA, Santesso N, Spencer FA, Shea B, Wells G, Helfand M. Non-randomized studies as a source of complementary, sequential or replacement evidence for randomized controlled trials in systematic reviews on the effects of interventions. Research Synthesis Methods 2013; 4 : 49-62.

Schünemann HJ. Interpreting GRADE's levels of certainty or quality of the evidence: GRADE for statisticians, considering review information size or less emphasis on imprecision? Journal of Clinical Epidemiology 2016; 75 : 6-15.

Schünemann HJ, Cuello C, Akl EA, Mustafa RA, Meerpohl JJ, Thayer K, Morgan RL, Gartlehner G, Kunz R, Katikireddi SV, Sterne J, Higgins JPT, Guyatt G, Group GW. GRADE guidelines: 18. How ROBINS-I and other tools to assess risk of bias in nonrandomized studies should be used to rate the certainty of a body of evidence. Journal of Clinical Epidemiology 2018.

Spencer-Bonilla G, Quinones AR, Montori VM, International Minimally Disruptive Medicine W. Assessing the Burden of Treatment. Journal of General Internal Medicine 2017; 32 : 1141-1145.

Spencer FA, Iorio A, You J, Murad MH, Schünemann HJ, Vandvik PO, Crowther MA, Pottie K, Lang ES, Meerpohl JJ, Falck-Ytter Y, Alonso-Coello P, Guyatt GH. Uncertainties in baseline risk estimates and confidence in treatment effects. BMJ 2012; 345 : e7401.

Sterne JAC, Hernán MA, Reeves BC, Savović J, Berkman ND, Viswanathan M, Henry D, Altman DG, Ansari MT, Boutron I, Carpenter JR, Chan AW, Churchill R, Deeks JJ, Hróbjartsson A, Kirkham J, Jüni P, Loke YK, Pigott TD, Ramsay CR, Regidor D, Rothstein HR, Sandhu L, Santaguida PL, Schünemann HJ, Shea B, Shrier I, Tugwell P, Turner L, Valentine JC, Waddington H, Waters E, Wells GA, Whiting PF, Higgins JPT. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ 2016; 355 : i4919.

Thompson DC, Rivara FP, Thompson R. Helmets for preventing head and facial injuries in bicyclists. Cochrane Database of Systematic Reviews 2000; 2 : CD001855.

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For permission to re-use material from the Handbook (either academic or commercial), please see here for full details.

How To Write The Results/Findings Chapter

For qualitative studies (dissertations & theses).

By: Jenna Crossley (PhD Cand). Expert Reviewed By: Dr. Eunice Rautenbach | August 2021

So, you’ve collected and analysed your qualitative data, and it’s time to write up your results chapter – exciting! But where do you start? In this post, we’ll guide you through the qualitative results chapter (also called the findings chapter), step by step.  

Overview: Qualitative Results Chapter

• What (exactly) the qualitative results chapter is
• What to include in your results chapter
• How to write up your results chapter
• A few tips and tricks to help you along the way

What exactly is the results chapter?

The results chapter in a dissertation or thesis (or any formal academic research piece) is where you objectively and neutrally present the findings of your qualitative analysis (or analyses if you used multiple qualitative analysis methods ). This chapter can sometimes be combined with the discussion chapter (where you interpret the data and discuss its meaning), depending on your university’s preference.  We’ll treat the two chapters as separate, as that’s the most common approach.

In contrast to a quantitative results chapter that presents numbers and statistics, a qualitative results chapter presents data primarily in the form of words . But this doesn’t mean that a qualitative study can’t have quantitative elements – you could, for example, present the number of times a theme or topic pops up in your data, depending on the analysis method(s) you adopt.

Adding a quantitative element to your study can add some rigour, which strengthens your results by providing more evidence for your claims. This is particularly common when using qualitative content analysis. Keep in mind though that qualitative research aims to achieve depth, richness and identify nuances , so don’t get tunnel vision by focusing on the numbers. They’re just cream on top in a qualitative analysis.

So, to recap, the results chapter is where you objectively present the findings of your analysis, without interpreting them (you’ll save that for the discussion chapter). With that out the way, let’s take a look at what you should include in your results chapter.

What should you include in the results chapter?

As we’ve mentioned, your qualitative results chapter should purely present and describe your results , not interpret them in relation to the existing literature or your research questions . Any speculations or discussion about the implications of your findings should be reserved for your discussion chapter.

In your results chapter, you’ll want to talk about your analysis findings and whether or not they support your hypotheses (if you have any). Naturally, the exact contents of your results chapter will depend on which qualitative analysis method (or methods) you use. For example, if you were to use thematic analysis, you’d detail the themes identified in your analysis, using extracts from the transcripts or text to support your claims.

While you do need to present your analysis findings in some detail, you should avoid dumping large amounts of raw data in this chapter. Instead, focus on presenting the key findings and using a handful of select quotes or text extracts to support each finding . The reams of data and analysis can be relegated to your appendices.

While it’s tempting to include every last detail you found in your qualitative analysis, it is important to make sure that you report only that which is relevant to your research aims, objectives and research questions .  Always keep these three components, as well as your hypotheses (if you have any) front of mind when writing the chapter and use them as a filter to decide what’s relevant and what’s not.

Need a helping hand?

How do I write the results chapter?

Now that we’ve covered the basics, it’s time to look at how to structure your chapter. Broadly speaking, the results chapter needs to contain three core components – the introduction, the body and the concluding summary. Let’s take a look at each of these.

Section 1: Introduction

The first step is to craft a brief introduction to the chapter. This intro is vital as it provides some context for your findings. In your introduction, you should begin by reiterating your problem statement and research questions and highlight the purpose of your research . Make sure that you spell this out for the reader so that the rest of your chapter is well contextualised.

The next step is to briefly outline the structure of your results chapter. In other words, explain what’s included in the chapter and what the reader can expect. In the results chapter, you want to tell a story that is coherent, flows logically, and is easy to follow , so make sure that you plan your structure out well and convey that structure (at a high level), so that your reader is well oriented.

The introduction section shouldn’t be lengthy. Two or three short paragraphs should be more than adequate. It is merely an introduction and overview, not a summary of the chapter.

Pro Tip – To help you structure your chapter, it can be useful to set up an initial draft with (sub)section headings so that you’re able to easily (re)arrange parts of your chapter. This will also help your reader to follow your results and give your chapter some coherence.  Be sure to use level-based heading styles (e.g. Heading 1, 2, 3 styles) to help the reader differentiate between levels visually. You can find these options in Word (example below).

Section 2: Body

Before we get started on what to include in the body of your chapter, it’s vital to remember that a results section should be completely objective and descriptive, not interpretive . So, be careful not to use words such as, “suggests” or “implies”, as these usually accompany some form of interpretation – that’s reserved for your discussion chapter.

The structure of your body section is very important , so make sure that you plan it out well. When planning out your qualitative results chapter, create sections and subsections so that you can maintain the flow of the story you’re trying to tell. Be sure to systematically and consistently describe each portion of results. Try to adopt a standardised structure for each portion so that you achieve a high level of consistency throughout the chapter.

For qualitative studies, results chapters tend to be structured according to themes , which makes it easier for readers to follow. However, keep in mind that not all results chapters have to be structured in this manner. For example, if you’re conducting a longitudinal study, you may want to structure your chapter chronologically. Similarly, you might structure this chapter based on your theoretical framework . The exact structure of your chapter will depend on the nature of your study , especially your research questions.

As you work through the body of your chapter, make sure that you use quotes to substantiate every one of your claims . You can present these quotes in italics to differentiate them from your own words. A general rule of thumb is to use at least two pieces of evidence per claim, and these should be linked directly to your data. Also, remember that you need to include all relevant results , not just the ones that support your assumptions or initial leanings.

In addition to including quotes, you can also link your claims to the data by using appendices , which you should reference throughout your text. When you reference, make sure that you include both the name/number of the appendix , as well as the line(s) from which you drew your data.

As referencing styles can vary greatly, be sure to look up the appendix referencing conventions of your university’s prescribed style (e.g. APA , Harvard, etc) and keep this consistent throughout your chapter.

Section 3: Concluding summary

The concluding summary is very important because it summarises your key findings and lays the foundation for the discussion chapter . Keep in mind that some readers may skip directly to this section (from the introduction section), so make sure that it can be read and understood well in isolation.

In this section, you need to remind the reader of the key findings. That is, the results that directly relate to your research questions and that you will build upon in your discussion chapter. Remember, your reader has digested a lot of information in this chapter, so you need to use this section to remind them of the most important takeaways.

Importantly, the concluding summary should not present any new information and should only describe what you’ve already presented in your chapter. Keep it concise – you’re not summarising the whole chapter, just the essentials.

Tips and tricks for an A-grade results chapter

Now that you’ve got a clear picture of what the qualitative results chapter is all about, here are some quick tips and reminders to help you craft a high-quality chapter:

• Your results chapter should be written in the past tense . You’ve done the work already, so you want to tell the reader what you found , not what you are currently finding .
• Make sure that you review your work multiple times and check that every claim is adequately backed up by evidence . Aim for at least two examples per claim, and make use of an appendix to reference these.
• When writing up your results, make sure that you stick to only what is relevant . Don’t waste time on data that are not relevant to your research objectives and research questions.
• Use headings and subheadings to create an intuitive, easy to follow piece of writing. Make use of Microsoft Word’s “heading styles” and be sure to use them consistently.
• When referring to numerical data, tables and figures can provide a useful visual aid. When using these, make sure that they can be read and understood independent of your body text (i.e. that they can stand-alone). To this end, use clear, concise labels for each of your tables or figures and make use of colours to code indicate differences or hierarchy.
• Similarly, when you’re writing up your chapter, it can be useful to highlight topics and themes in different colours . This can help you to differentiate between your data if you get a bit overwhelmed and will also help you to ensure that your results flow logically and coherently.

If you have any questions, leave a comment below and we’ll do our best to help. If you’d like 1-on-1 help with your results chapter (or any chapter of your dissertation or thesis), check out our private dissertation coaching service here or book a free initial consultation to discuss how we can help you.

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20 Comments

This was extremely helpful. Thanks a lot guys

Hi, thanks for the great research support platform created by the gradcoach team!

I wanted to ask- While “suggests” or “implies” are interpretive terms, what terms could we use for the results chapter? Could you share some examples of descriptive terms?

I think that instead of saying, ‘The data suggested, or The data implied,’ you can say, ‘The Data showed or revealed, or illustrated or outlined’…If interview data, you may say Jane Doe illuminated or elaborated, or Jane Doe described… or Jane Doe expressed or stated.

I found this article very useful. Thank you very much for the outstanding work you are doing.

What if i have 3 different interviewees answering the same interview questions? Should i then present the results in form of the table with the division on the 3 perspectives or rather give a results in form of the text and highlight who said what?

I think this tabular representation of results is a great idea. I am doing it too along with the text. Thanks

That was helpful was struggling to separate the discussion from the findings

this was very useful, Thank you.

Very helpful, I am confident to write my results chapter now.

It is so helpful! It is a good job. Thank you very much!

Very useful, well explained. Many thanks.

Hello, I appreciate the way you provided a supportive comments about qualitative results presenting tips

I loved this! It explains everything needed, and it has helped me better organize my thoughts. What words should I not use while writing my results section, other than subjective ones.

Thanks a lot, it is really helpful

Thank you so much dear, i really appropriate your nice explanations about this.

Thank you so much for this! I was wondering if anyone could help with how to prproperly integrate quotations (Excerpts) from interviews in the finding chapter in a qualitative research. Please GradCoach, address this issue and provide examples.

what if I’m not doing any interviews myself and all the information is coming from case studies that have already done the research.

Very helpful thank you.

This was very helpful as I was wondering how to structure this part of my dissertation, to include the quotes… Thanks for this explanation

This is very helpful, thanks! I am required to write up my results chapters with the discussion in each of them – any tips and tricks for this strategy?

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Criteria for Good Qualitative Research: A Comprehensive Review

• Regular Article
• Open access
• Published: 18 September 2021
• Volume 31 , pages 679–689, ( 2022 )

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• Drishti Yadav   ORCID: orcid.org/0000-0002-2974-0323 1  

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This review aims to synthesize a published set of evaluative criteria for good qualitative research. The aim is to shed light on existing standards for assessing the rigor of qualitative research encompassing a range of epistemological and ontological standpoints. Using a systematic search strategy, published journal articles that deliberate criteria for rigorous research were identified. Then, references of relevant articles were surveyed to find noteworthy, distinct, and well-defined pointers to good qualitative research. This review presents an investigative assessment of the pivotal features in qualitative research that can permit the readers to pass judgment on its quality and to condemn it as good research when objectively and adequately utilized. Overall, this review underlines the crux of qualitative research and accentuates the necessity to evaluate such research by the very tenets of its being. It also offers some prospects and recommendations to improve the quality of qualitative research. Based on the findings of this review, it is concluded that quality criteria are the aftereffect of socio-institutional procedures and existing paradigmatic conducts. Owing to the paradigmatic diversity of qualitative research, a single and specific set of quality criteria is neither feasible nor anticipated. Since qualitative research is not a cohesive discipline, researchers need to educate and familiarize themselves with applicable norms and decisive factors to evaluate qualitative research from within its theoretical and methodological framework of origin.

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Introduction

“… It is important to regularly dialogue about what makes for good qualitative research” (Tracy, 2010 , p. 837)

To decide what represents good qualitative research is highly debatable. There are numerous methods that are contained within qualitative research and that are established on diverse philosophical perspectives. Bryman et al., ( 2008 , p. 262) suggest that “It is widely assumed that whereas quality criteria for quantitative research are well‐known and widely agreed, this is not the case for qualitative research.” Hence, the question “how to evaluate the quality of qualitative research” has been continuously debated. There are many areas of science and technology wherein these debates on the assessment of qualitative research have taken place. Examples include various areas of psychology: general psychology (Madill et al., 2000 ); counseling psychology (Morrow, 2005 ); and clinical psychology (Barker & Pistrang, 2005 ), and other disciplines of social sciences: social policy (Bryman et al., 2008 ); health research (Sparkes, 2001 ); business and management research (Johnson et al., 2006 ); information systems (Klein & Myers, 1999 ); and environmental studies (Reid & Gough, 2000 ). In the literature, these debates are enthused by the impression that the blanket application of criteria for good qualitative research developed around the positivist paradigm is improper. Such debates are based on the wide range of philosophical backgrounds within which qualitative research is conducted (e.g., Sandberg, 2000 ; Schwandt, 1996 ). The existence of methodological diversity led to the formulation of different sets of criteria applicable to qualitative research.

Among qualitative researchers, the dilemma of governing the measures to assess the quality of research is not a new phenomenon, especially when the virtuous triad of objectivity, reliability, and validity (Spencer et al., 2004 ) are not adequate. Occasionally, the criteria of quantitative research are used to evaluate qualitative research (Cohen & Crabtree, 2008 ; Lather, 2004 ). Indeed, Howe ( 2004 ) claims that the prevailing paradigm in educational research is scientifically based experimental research. Hypotheses and conjectures about the preeminence of quantitative research can weaken the worth and usefulness of qualitative research by neglecting the prominence of harmonizing match for purpose on research paradigm, the epistemological stance of the researcher, and the choice of methodology. Researchers have been reprimanded concerning this in “paradigmatic controversies, contradictions, and emerging confluences” (Lincoln & Guba, 2000 ).

In general, qualitative research tends to come from a very different paradigmatic stance and intrinsically demands distinctive and out-of-the-ordinary criteria for evaluating good research and varieties of research contributions that can be made. This review attempts to present a series of evaluative criteria for qualitative researchers, arguing that their choice of criteria needs to be compatible with the unique nature of the research in question (its methodology, aims, and assumptions). This review aims to assist researchers in identifying some of the indispensable features or markers of high-quality qualitative research. In a nutshell, the purpose of this systematic literature review is to analyze the existing knowledge on high-quality qualitative research and to verify the existence of research studies dealing with the critical assessment of qualitative research based on the concept of diverse paradigmatic stances. Contrary to the existing reviews, this review also suggests some critical directions to follow to improve the quality of qualitative research in different epistemological and ontological perspectives. This review is also intended to provide guidelines for the acceleration of future developments and dialogues among qualitative researchers in the context of assessing the qualitative research.

The rest of this review article is structured in the following fashion: Sect.  Methods describes the method followed for performing this review. Section Criteria for Evaluating Qualitative Studies provides a comprehensive description of the criteria for evaluating qualitative studies. This section is followed by a summary of the strategies to improve the quality of qualitative research in Sect.  Improving Quality: Strategies . Section  How to Assess the Quality of the Research Findings? provides details on how to assess the quality of the research findings. After that, some of the quality checklists (as tools to evaluate quality) are discussed in Sect.  Quality Checklists: Tools for Assessing the Quality . At last, the review ends with the concluding remarks presented in Sect.  Conclusions, Future Directions and Outlook . Some prospects in qualitative research for enhancing its quality and usefulness in the social and techno-scientific research community are also presented in Sect.  Conclusions, Future Directions and Outlook .

For this review, a comprehensive literature search was performed from many databases using generic search terms such as Qualitative Research , Criteria , etc . The following databases were chosen for the literature search based on the high number of results: IEEE Explore, ScienceDirect, PubMed, Google Scholar, and Web of Science. The following keywords (and their combinations using Boolean connectives OR/AND) were adopted for the literature search: qualitative research, criteria, quality, assessment, and validity. The synonyms for these keywords were collected and arranged in a logical structure (see Table 1 ). All publications in journals and conference proceedings later than 1950 till 2021 were considered for the search. Other articles extracted from the references of the papers identified in the electronic search were also included. A large number of publications on qualitative research were retrieved during the initial screening. Hence, to include the searches with the main focus on criteria for good qualitative research, an inclusion criterion was utilized in the search string.

From the selected databases, the search retrieved a total of 765 publications. Then, the duplicate records were removed. After that, based on the title and abstract, the remaining 426 publications were screened for their relevance by using the following inclusion and exclusion criteria (see Table 2 ). Publications focusing on evaluation criteria for good qualitative research were included, whereas those works which delivered theoretical concepts on qualitative research were excluded. Based on the screening and eligibility, 45 research articles were identified that offered explicit criteria for evaluating the quality of qualitative research and were found to be relevant to this review.

Figure  1 illustrates the complete review process in the form of PRISMA flow diagram. PRISMA, i.e., “preferred reporting items for systematic reviews and meta-analyses” is employed in systematic reviews to refine the quality of reporting.

PRISMA flow diagram illustrating the search and inclusion process. N represents the number of records

Criteria for Evaluating Qualitative Studies

Fundamental criteria: general research quality.

Various researchers have put forward criteria for evaluating qualitative research, which have been summarized in Table 3 . Also, the criteria outlined in Table 4 effectively deliver the various approaches to evaluate and assess the quality of qualitative work. The entries in Table 4 are based on Tracy’s “Eight big‐tent criteria for excellent qualitative research” (Tracy, 2010 ). Tracy argues that high-quality qualitative work should formulate criteria focusing on the worthiness, relevance, timeliness, significance, morality, and practicality of the research topic, and the ethical stance of the research itself. Researchers have also suggested a series of questions as guiding principles to assess the quality of a qualitative study (Mays & Pope, 2020 ). Nassaji ( 2020 ) argues that good qualitative research should be robust, well informed, and thoroughly documented.

Qualitative Research: Interpretive Paradigms

All qualitative researchers follow highly abstract principles which bring together beliefs about ontology, epistemology, and methodology. These beliefs govern how the researcher perceives and acts. The net, which encompasses the researcher’s epistemological, ontological, and methodological premises, is referred to as a paradigm, or an interpretive structure, a “Basic set of beliefs that guides action” (Guba, 1990 ). Four major interpretive paradigms structure the qualitative research: positivist and postpositivist, constructivist interpretive, critical (Marxist, emancipatory), and feminist poststructural. The complexity of these four abstract paradigms increases at the level of concrete, specific interpretive communities. Table 5 presents these paradigms and their assumptions, including their criteria for evaluating research, and the typical form that an interpretive or theoretical statement assumes in each paradigm. Moreover, for evaluating qualitative research, quantitative conceptualizations of reliability and validity are proven to be incompatible (Horsburgh, 2003 ). In addition, a series of questions have been put forward in the literature to assist a reviewer (who is proficient in qualitative methods) for meticulous assessment and endorsement of qualitative research (Morse, 2003 ). Hammersley ( 2007 ) also suggests that guiding principles for qualitative research are advantageous, but methodological pluralism should not be simply acknowledged for all qualitative approaches. Seale ( 1999 ) also points out the significance of methodological cognizance in research studies.

Table 5 reflects that criteria for assessing the quality of qualitative research are the aftermath of socio-institutional practices and existing paradigmatic standpoints. Owing to the paradigmatic diversity of qualitative research, a single set of quality criteria is neither possible nor desirable. Hence, the researchers must be reflexive about the criteria they use in the various roles they play within their research community.

Improving Quality: Strategies

Another critical question is “How can the qualitative researchers ensure that the abovementioned quality criteria can be met?” Lincoln and Guba ( 1986 ) delineated several strategies to intensify each criteria of trustworthiness. Other researchers (Merriam & Tisdell, 2016 ; Shenton, 2004 ) also presented such strategies. A brief description of these strategies is shown in Table 6 .

It is worth mentioning that generalizability is also an integral part of qualitative research (Hays & McKibben, 2021 ). In general, the guiding principle pertaining to generalizability speaks about inducing and comprehending knowledge to synthesize interpretive components of an underlying context. Table 7 summarizes the main metasynthesis steps required to ascertain generalizability in qualitative research.

Figure  2 reflects the crucial components of a conceptual framework and their contribution to decisions regarding research design, implementation, and applications of results to future thinking, study, and practice (Johnson et al., 2020 ). The synergy and interrelationship of these components signifies their role to different stances of a qualitative research study.

Essential elements of a conceptual framework

In a nutshell, to assess the rationale of a study, its conceptual framework and research question(s), quality criteria must take account of the following: lucid context for the problem statement in the introduction; well-articulated research problems and questions; precise conceptual framework; distinct research purpose; and clear presentation and investigation of the paradigms. These criteria would expedite the quality of qualitative research.

How to Assess the Quality of the Research Findings?

The inclusion of quotes or similar research data enhances the confirmability in the write-up of the findings. The use of expressions (for instance, “80% of all respondents agreed that” or “only one of the interviewees mentioned that”) may also quantify qualitative findings (Stenfors et al., 2020 ). On the other hand, the persuasive reason for “why this may not help in intensifying the research” has also been provided (Monrouxe & Rees, 2020 ). Further, the Discussion and Conclusion sections of an article also prove robust markers of high-quality qualitative research, as elucidated in Table 8 .

Quality Checklists: Tools for Assessing the Quality

Numerous checklists are available to speed up the assessment of the quality of qualitative research. However, if used uncritically and recklessly concerning the research context, these checklists may be counterproductive. I recommend that such lists and guiding principles may assist in pinpointing the markers of high-quality qualitative research. However, considering enormous variations in the authors’ theoretical and philosophical contexts, I would emphasize that high dependability on such checklists may say little about whether the findings can be applied in your setting. A combination of such checklists might be appropriate for novice researchers. Some of these checklists are listed below:

The most commonly used framework is Consolidated Criteria for Reporting Qualitative Research (COREQ) (Tong et al., 2007 ). This framework is recommended by some journals to be followed by the authors during article submission.

Standards for Reporting Qualitative Research (SRQR) is another checklist that has been created particularly for medical education (O’Brien et al., 2014 ).

Also, Tracy ( 2010 ) and Critical Appraisal Skills Programme (CASP, 2021 ) offer criteria for qualitative research relevant across methods and approaches.

Further, researchers have also outlined different criteria as hallmarks of high-quality qualitative research. For instance, the “Road Trip Checklist” (Epp & Otnes, 2021 ) provides a quick reference to specific questions to address different elements of high-quality qualitative research.

Conclusions, Future Directions, and Outlook

This work presents a broad review of the criteria for good qualitative research. In addition, this article presents an exploratory analysis of the essential elements in qualitative research that can enable the readers of qualitative work to judge it as good research when objectively and adequately utilized. In this review, some of the essential markers that indicate high-quality qualitative research have been highlighted. I scope them narrowly to achieve rigor in qualitative research and note that they do not completely cover the broader considerations necessary for high-quality research. This review points out that a universal and versatile one-size-fits-all guideline for evaluating the quality of qualitative research does not exist. In other words, this review also emphasizes the non-existence of a set of common guidelines among qualitative researchers. In unison, this review reinforces that each qualitative approach should be treated uniquely on account of its own distinctive features for different epistemological and disciplinary positions. Owing to the sensitivity of the worth of qualitative research towards the specific context and the type of paradigmatic stance, researchers should themselves analyze what approaches can be and must be tailored to ensemble the distinct characteristics of the phenomenon under investigation. Although this article does not assert to put forward a magic bullet and to provide a one-stop solution for dealing with dilemmas about how, why, or whether to evaluate the “goodness” of qualitative research, it offers a platform to assist the researchers in improving their qualitative studies. This work provides an assembly of concerns to reflect on, a series of questions to ask, and multiple sets of criteria to look at, when attempting to determine the quality of qualitative research. Overall, this review underlines the crux of qualitative research and accentuates the need to evaluate such research by the very tenets of its being. Bringing together the vital arguments and delineating the requirements that good qualitative research should satisfy, this review strives to equip the researchers as well as reviewers to make well-versed judgment about the worth and significance of the qualitative research under scrutiny. In a nutshell, a comprehensive portrayal of the research process (from the context of research to the research objectives, research questions and design, speculative foundations, and from approaches of collecting data to analyzing the results, to deriving inferences) frequently proliferates the quality of a qualitative research.

Prospects : A Road Ahead for Qualitative Research

Irrefutably, qualitative research is a vivacious and evolving discipline wherein different epistemological and disciplinary positions have their own characteristics and importance. In addition, not surprisingly, owing to the sprouting and varied features of qualitative research, no consensus has been pulled off till date. Researchers have reflected various concerns and proposed several recommendations for editors and reviewers on conducting reviews of critical qualitative research (Levitt et al., 2021 ; McGinley et al., 2021 ). Following are some prospects and a few recommendations put forward towards the maturation of qualitative research and its quality evaluation:

In general, most of the manuscript and grant reviewers are not qualitative experts. Hence, it is more likely that they would prefer to adopt a broad set of criteria. However, researchers and reviewers need to keep in mind that it is inappropriate to utilize the same approaches and conducts among all qualitative research. Therefore, future work needs to focus on educating researchers and reviewers about the criteria to evaluate qualitative research from within the suitable theoretical and methodological context.

There is an urgent need to refurbish and augment critical assessment of some well-known and widely accepted tools (including checklists such as COREQ, SRQR) to interrogate their applicability on different aspects (along with their epistemological ramifications).

Efforts should be made towards creating more space for creativity, experimentation, and a dialogue between the diverse traditions of qualitative research. This would potentially help to avoid the enforcement of one's own set of quality criteria on the work carried out by others.

Moreover, journal reviewers need to be aware of various methodological practices and philosophical debates.

It is pivotal to highlight the expressions and considerations of qualitative researchers and bring them into a more open and transparent dialogue about assessing qualitative research in techno-scientific, academic, sociocultural, and political rooms.

Frequent debates on the use of evaluative criteria are required to solve some potentially resolved issues (including the applicability of a single set of criteria in multi-disciplinary aspects). Such debates would not only benefit the group of qualitative researchers themselves, but primarily assist in augmenting the well-being and vivacity of the entire discipline.

To conclude, I speculate that the criteria, and my perspective, may transfer to other methods, approaches, and contexts. I hope that they spark dialog and debate – about criteria for excellent qualitative research and the underpinnings of the discipline more broadly – and, therefore, help improve the quality of a qualitative study. Further, I anticipate that this review will assist the researchers to contemplate on the quality of their own research, to substantiate research design and help the reviewers to review qualitative research for journals. On a final note, I pinpoint the need to formulate a framework (encompassing the prerequisites of a qualitative study) by the cohesive efforts of qualitative researchers of different disciplines with different theoretic-paradigmatic origins. I believe that tailoring such a framework (of guiding principles) paves the way for qualitative researchers to consolidate the status of qualitative research in the wide-ranging open science debate. Dialogue on this issue across different approaches is crucial for the impending prospects of socio-techno-educational research.

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Yadav, D. Criteria for Good Qualitative Research: A Comprehensive Review. Asia-Pacific Edu Res 31 , 679–689 (2022). https://doi.org/10.1007/s40299-021-00619-0

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How To Write A Research Summary

It’s a common perception that writing a research summary is a quick and easy task. After all, how hard can jotting down 300 words be? But when you consider the weight those 300 words carry, writing a research summary as a part of your dissertation, essay or compelling draft for your paper instantly becomes daunting task.

A research summary requires you to synthesize a complex research paper into an informative, self-explanatory snapshot. It needs to portray what your article contains. Thus, writing it often comes at the end of the task list.

Regardless of when you’re planning to write, it is no less of a challenge, particularly if you’re doing it for the first time. This blog will take you through everything you need to know about research summary so that you have an easier time with it.

What is a Research Summary?

A research summary is the part of your research paper that describes its findings to the audience in a brief yet concise manner. A well-curated research summary represents you and your knowledge about the information written in the research paper.

While writing a quality research summary, you need to discover and identify the significant points in the research and condense it in a more straightforward form. A research summary is like a doorway that provides access to the structure of a research paper's sections.

Since the purpose of a summary is to give an overview of the topic, methodology, and conclusions employed in a paper, it requires an objective approach. No analysis or criticism.

Research summary or Abstract. What’s the Difference?

They’re both brief, concise, and give an overview of an aspect of the research paper. So, it’s easy to understand why many new researchers get the two confused. However, a research summary and abstract are two very different things with individual purpose. To start with, a research summary is written at the end while the abstract comes at the beginning of a research paper.

A research summary captures the essence of the paper at the end of your document. It focuses on your topic, methods, and findings. More like a TL;DR, if you will. An abstract, on the other hand, is a description of what your research paper is about. It tells your reader what your topic or hypothesis is, and sets a context around why you have embarked on your research.

Getting Started with a Research Summary

Before you start writing, you need to get insights into your research’s content, style, and organization. There are three fundamental areas of a research summary that you should focus on.

• While deciding the contents of your research summary, you must include a section on its importance as a whole, the techniques, and the tools that were used to formulate the conclusion. Additionally, there needs to be a short but thorough explanation of how the findings of the research paper have a significance.
• To keep the summary well-organized, try to cover the various sections of the research paper in separate paragraphs. Besides, how the idea of particular factual research came up first must be explained in a separate paragraph.
• As a general practice worldwide, research summaries are restricted to 300-400 words. However, if you have chosen a lengthy research paper, try not to exceed the word limit of 10% of the entire research paper.

How to Structure Your Research Summary

The research summary is nothing but a concise form of the entire research paper. Therefore, the structure of a summary stays the same as the paper. So, include all the section titles and write a little about them. The structural elements that a research summary must consist of are:

It represents the topic of the research. Try to phrase it so that it includes the key findings or conclusion of the task.

The abstract gives a context of the research paper. Unlike the abstract at the beginning of a paper, the abstract here, should be very short since you’ll be working with a limited word count.

Introduction

This is the most crucial section of a research summary as it helps readers get familiarized with the topic. You should include the definition of your topic, the current state of the investigation, and practical relevance in this part. Additionally, you should present the problem statement, investigative measures, and any hypothesis in this section.

Methodology

This section provides details about the methodology and the methods adopted to conduct the study. You should write a brief description of the surveys, sampling, type of experiments, statistical analysis, and the rationality behind choosing those particular methods.

Create a list of evidence obtained from the various experiments with a primary analysis, conclusions, and interpretations made upon that. In the paper research paper, you will find the results section as the most detailed and lengthy part. Therefore, you must pick up the key elements and wisely decide which elements are worth including and which are worth skipping.

This is where you present the interpretation of results in the context of their application. Discussion usually covers results, inferences, and theoretical models explaining the obtained values, key strengths, and limitations. All of these are vital elements that you must include in the summary.

Most research papers merge conclusion with discussions. However, depending upon the instructions, you may have to prepare this as a separate section in your research summary. Usually, conclusion revisits the hypothesis and provides the details about the validation or denial about the arguments made in the research paper, based upon how convincing the results were obtained.

The structure of a research summary closely resembles the anatomy of a scholarly article . Additionally, you should keep your research and references limited to authentic and  scholarly sources only.

Tips for Writing a Research Summary

The core concept behind undertaking a research summary is to present a simple and clear understanding of your research paper to the reader. The biggest hurdle while doing that is the number of words you have at your disposal. So, follow the steps below to write a research summary that sticks.

1. Read the parent paper thoroughly

You should go through the research paper thoroughly multiple times to ensure that you have a complete understanding of its contents. A 3-stage reading process helps.

a. Scan: In the first read, go through it to get an understanding of its basic concept and methodologies.

b. Read: For the second step, read the article attentively by going through each section, highlighting the key elements, and subsequently listing the topics that you will include in your research summary.

c. Skim: Flip through the article a few more times to study the interpretation of various experimental results, statistical analysis, and application in different contexts.

Sincerely go through different headings and subheadings as it will allow you to understand the underlying concept of each section. You can try reading the introduction and conclusion simultaneously to understand the motive of the task and how obtained results stay fit to the expected outcome.

2. Identify the key elements in different sections

While exploring different sections of an article, you can try finding answers to simple what, why, and how. Below are a few pointers to give you an idea:

• What is the research question and how is it addressed?
• Is there a hypothesis in the introductory part?
• What type of methods are being adopted?
• What is the sample size for data collection and how is it being analyzed?
• What are the most vital findings?
• Do the results support the hypothesis?

Discussion/Conclusion

• What is the final solution to the problem statement?
• What is the explanation for the obtained results?
• What is the drawn inference?
• What are the various limitations of the study?

3. Prepare the first draft

Now that you’ve listed the key points that the paper tries to demonstrate, you can start writing the summary following the standard structure of a research summary. Just make sure you’re not writing statements from the parent research paper verbatim.

Instead, try writing down each section in your own words. This will not only help in avoiding plagiarism but will also show your complete understanding of the subject. Alternatively, you can use a summarizing tool (AI-based summary generators) to shorten the content or summarize the content without disrupting the actual meaning of the article.

SciSpace Copilot is one such helpful feature! You can easily upload your research paper and ask Copilot to summarize it. You will get an AI-generated, condensed research summary. SciSpace Copilot also enables you to highlight text, clip math and tables, and ask any question relevant to the research paper; it will give you instant answers with deeper context of the article..

4. Include visuals

One of the best ways to summarize and consolidate a research paper is to provide visuals like graphs, charts, pie diagrams, etc.. Visuals make getting across the facts, the past trends, and the probabilistic figures around a concept much more engaging.

5. Double check for plagiarism

It can be very tempting to copy-paste a few statements or the entire paragraphs depending upon the clarity of those sections. But it’s best to stay away from the practice. Even paraphrasing should be done with utmost care and attention.

Also: QuillBot vs SciSpace: Choose the best AI-paraphrasing tool

6. Religiously follow the word count limit

You need to have strict control while writing different sections of a research summary. In many cases, it has been observed that the research summary and the parent research paper become the same length. If that happens, it can lead to discrediting of your efforts and research summary itself. Whatever the standard word limit has been imposed, you must observe that carefully.

7. Proofread your research summary multiple times

The process of writing the research summary can be exhausting and tiring. However, you shouldn’t allow this to become a reason to skip checking your academic writing several times for mistakes like misspellings, grammar, wordiness, and formatting issues. Proofread and edit until you think your research summary can stand out from the others, provided it is drafted perfectly on both technicality and comprehension parameters. You can also seek assistance from editing and proofreading services , and other free tools that help you keep these annoying grammatical errors at bay.

8. Watch while you write

Keep a keen observation of your writing style. You should use the words very precisely, and in any situation, it should not represent your personal opinions on the topic. You should write the entire research summary in utmost impersonal, precise, factually correct, and evidence-based writing.

9. Ask a friend/colleague to help

Once you are done with the final copy of your research summary, you must ask a friend or colleague to read it. You must test whether your friend or colleague could grasp everything without referring to the parent paper. This will help you in ensuring the clarity of the article.

Once you become familiar with the research paper summary concept and understand how to apply the tips discussed above in your current task, summarizing a research summary won’t be that challenging. While traversing the different stages of your academic career, you will face different scenarios where you may have to create several research summaries.

In such cases, you just need to look for answers to simple questions like “Why this study is necessary,” “what were the methods,” “who were the participants,” “what conclusions were drawn from the research,” and “how it is relevant to the wider world.” Once you find out the answers to these questions, you can easily create a good research summary following the standard structure and a precise writing style.

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Research Summary – Structure, Examples and Writing Guide

Table of Contents

Research Summary

Definition:

A research summary is a brief and concise overview of a research project or study that highlights its key findings, main points, and conclusions. It typically includes a description of the research problem, the research methods used, the results obtained, and the implications or significance of the findings. It is often used as a tool to quickly communicate the main findings of a study to other researchers, stakeholders, or decision-makers.

Structure of Research Summary

The Structure of a Research Summary typically include:

• Introduction : This section provides a brief background of the research problem or question, explains the purpose of the study, and outlines the research objectives.
• Methodology : This section explains the research design, methods, and procedures used to conduct the study. It describes the sample size, data collection methods, and data analysis techniques.
• Results : This section presents the main findings of the study, including statistical analysis if applicable. It may include tables, charts, or graphs to visually represent the data.
• Discussion : This section interprets the results and explains their implications. It discusses the significance of the findings, compares them to previous research, and identifies any limitations or future directions for research.
• Conclusion : This section summarizes the main points of the research and provides a conclusion based on the findings. It may also suggest implications for future research or practical applications of the results.
• References : This section lists the sources cited in the research summary, following the appropriate citation style.

How to Write Research Summary

Here are the steps you can follow to write a research summary:

• Read the research article or study thoroughly: To write a summary, you must understand the research article or study you are summarizing. Therefore, read the article or study carefully to understand its purpose, research design, methodology, results, and conclusions.
• Identify the main points : Once you have read the research article or study, identify the main points, key findings, and research question. You can highlight or take notes of the essential points and findings to use as a reference when writing your summary.
• Write the introduction: Start your summary by introducing the research problem, research question, and purpose of the study. Briefly explain why the research is important and its significance.
• Summarize the methodology : In this section, summarize the research design, methods, and procedures used to conduct the study. Explain the sample size, data collection methods, and data analysis techniques.
• Present the results: Summarize the main findings of the study. Use tables, charts, or graphs to visually represent the data if necessary.
• Interpret the results: In this section, interpret the results and explain their implications. Discuss the significance of the findings, compare them to previous research, and identify any limitations or future directions for research.
• Conclude the summary : Summarize the main points of the research and provide a conclusion based on the findings. Suggest implications for future research or practical applications of the results.
• Revise and edit : Once you have written the summary, revise and edit it to ensure that it is clear, concise, and free of errors. Make sure that your summary accurately represents the research article or study.
• Add references: Include a list of references cited in the research summary, following the appropriate citation style.

Example of Research Summary

Here is an example of a research summary:

Title: The Effects of Yoga on Mental Health: A Meta-Analysis

Introduction: This meta-analysis examines the effects of yoga on mental health. The study aimed to investigate whether yoga practice can improve mental health outcomes such as anxiety, depression, stress, and quality of life.

Methodology : The study analyzed data from 14 randomized controlled trials that investigated the effects of yoga on mental health outcomes. The sample included a total of 862 participants. The yoga interventions varied in length and frequency, ranging from four to twelve weeks, with sessions lasting from 45 to 90 minutes.

Results : The meta-analysis found that yoga practice significantly improved mental health outcomes. Participants who practiced yoga showed a significant reduction in anxiety and depression symptoms, as well as stress levels. Quality of life also improved in those who practiced yoga.

Discussion : The findings of this study suggest that yoga can be an effective intervention for improving mental health outcomes. The study supports the growing body of evidence that suggests that yoga can have a positive impact on mental health. Limitations of the study include the variability of the yoga interventions, which may affect the generalizability of the findings.

Conclusion : Overall, the findings of this meta-analysis support the use of yoga as an effective intervention for improving mental health outcomes. Further research is needed to determine the optimal length and frequency of yoga interventions for different populations.

References :

• Cramer, H., Lauche, R., Langhorst, J., Dobos, G., & Berger, B. (2013). Yoga for depression: a systematic review and meta-analysis. Depression and anxiety, 30(11), 1068-1083.
• Khalsa, S. B. (2004). Yoga as a therapeutic intervention: a bibliometric analysis of published research studies. Indian journal of physiology and pharmacology, 48(3), 269-285.
• Ross, A., & Thomas, S. (2010). The health benefits of yoga and exercise: a review of comparison studies. The Journal of Alternative and Complementary Medicine, 16(1), 3-12.

Purpose of Research Summary

The purpose of a research summary is to provide a brief overview of a research project or study, including its main points, findings, and conclusions. The summary allows readers to quickly understand the essential aspects of the research without having to read the entire article or study.

Research summaries serve several purposes, including:

• Facilitating comprehension: A research summary allows readers to quickly understand the main points and findings of a research project or study without having to read the entire article or study. This makes it easier for readers to comprehend the research and its significance.
• Communicating research findings: Research summaries are often used to communicate research findings to a wider audience, such as policymakers, practitioners, or the general public. The summary presents the essential aspects of the research in a clear and concise manner, making it easier for non-experts to understand.
• Supporting decision-making: Research summaries can be used to support decision-making processes by providing a summary of the research evidence on a particular topic. This information can be used by policymakers or practitioners to make informed decisions about interventions, programs, or policies.
• Saving time: Research summaries save time for researchers, practitioners, policymakers, and other stakeholders who need to review multiple research studies. Rather than having to read the entire article or study, they can quickly review the summary to determine whether the research is relevant to their needs.

Characteristics of Research Summary

The following are some of the key characteristics of a research summary:

• Concise : A research summary should be brief and to the point, providing a clear and concise overview of the main points of the research.
• Objective : A research summary should be written in an objective tone, presenting the research findings without bias or personal opinion.
• Comprehensive : A research summary should cover all the essential aspects of the research, including the research question, methodology, results, and conclusions.
• Accurate : A research summary should accurately reflect the key findings and conclusions of the research.
• Clear and well-organized: A research summary should be easy to read and understand, with a clear structure and logical flow.
• Relevant : A research summary should focus on the most important and relevant aspects of the research, highlighting the key findings and their implications.
• Audience-specific: A research summary should be tailored to the intended audience, using language and terminology that is appropriate and accessible to the reader.
• Citations : A research summary should include citations to the original research articles or studies, allowing readers to access the full text of the research if desired.

When to write Research Summary

Here are some situations when it may be appropriate to write a research summary:

• Proposal stage: A research summary can be included in a research proposal to provide a brief overview of the research aims, objectives, methodology, and expected outcomes.
• Conference presentation: A research summary can be prepared for a conference presentation to summarize the main findings of a study or research project.
• Journal submission: Many academic journals require authors to submit a research summary along with their research article or study. The summary provides a brief overview of the study’s main points, findings, and conclusions and helps readers quickly understand the research.
• Funding application: A research summary can be included in a funding application to provide a brief summary of the research aims, objectives, and expected outcomes.
• Policy brief: A research summary can be prepared as a policy brief to communicate research findings to policymakers or stakeholders in a concise and accessible manner.

Advantages of Research Summary

Research summaries offer several advantages, including:

• Time-saving: A research summary saves time for readers who need to understand the key findings and conclusions of a research project quickly. Rather than reading the entire research article or study, readers can quickly review the summary to determine whether the research is relevant to their needs.
• Clarity and accessibility: A research summary provides a clear and accessible overview of the research project’s main points, making it easier for readers to understand the research without having to be experts in the field.
• Improved comprehension: A research summary helps readers comprehend the research by providing a brief and focused overview of the key findings and conclusions, making it easier to understand the research and its significance.
• Enhanced communication: Research summaries can be used to communicate research findings to a wider audience, such as policymakers, practitioners, or the general public, in a concise and accessible manner.
• Facilitated decision-making: Research summaries can support decision-making processes by providing a summary of the research evidence on a particular topic. Policymakers or practitioners can use this information to make informed decisions about interventions, programs, or policies.
• Increased dissemination: Research summaries can be easily shared and disseminated, allowing research findings to reach a wider audience.

Limitations of Research Summary

Limitations of the Research Summary are as follows:

• Limited scope: Research summaries provide a brief overview of the research project’s main points, findings, and conclusions, which can be limiting. They may not include all the details, nuances, and complexities of the research that readers may need to fully understand the study’s implications.
• Risk of oversimplification: Research summaries can be oversimplified, reducing the complexity of the research and potentially distorting the findings or conclusions.
• Lack of context: Research summaries may not provide sufficient context to fully understand the research findings, such as the research background, methodology, or limitations. This may lead to misunderstandings or misinterpretations of the research.
• Possible bias: Research summaries may be biased if they selectively emphasize certain findings or conclusions over others, potentially distorting the overall picture of the research.
• Format limitations: Research summaries may be constrained by the format or length requirements, making it challenging to fully convey the research’s main points, findings, and conclusions.
• Accessibility: Research summaries may not be accessible to all readers, particularly those with limited literacy skills, visual impairments, or language barriers.

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Qualitative Data Analysis

23 Presenting the Results of Qualitative Analysis

Mikaila Mariel Lemonik Arthur

Qualitative research is not finished just because you have determined the main findings or conclusions of your study. Indeed, disseminating the results is an essential part of the research process. By sharing your results with others, whether in written form as scholarly paper or an applied report or in some alternative format like an oral presentation, an infographic, or a video, you ensure that your findings become part of the ongoing conversation of scholarship in your field, forming part of the foundation for future researchers. This chapter provides an introduction to writing about qualitative research findings. It will outline how writing continues to contribute to the analysis process, what concerns researchers should keep in mind as they draft their presentations of findings, and how best to organize qualitative research writing

As you move through the research process, it is essential to keep yourself organized. Organizing your data, memos, and notes aids both the analytical and the writing processes. Whether you use electronic or physical, real-world filing and organizational systems, these systems help make sense of the mountains of data you have and assure you focus your attention on the themes and ideas you have determined are important (Warren and Karner 2015). Be sure that you have kept detailed notes on all of the decisions you have made and procedures you have followed in carrying out research design, data collection, and analysis, as these will guide your ultimate write-up.

First and foremost, researchers should keep in mind that writing is in fact a form of thinking. Writing is an excellent way to discover ideas and arguments and to further develop an analysis. As you write, more ideas will occur to you, things that were previously confusing will start to make sense, and arguments will take a clear shape rather than being amorphous and poorly-organized. However, writing-as-thinking cannot be the final version that you share with others. Good-quality writing does not display the workings of your thought process. It is reorganized and revised (more on that later) to present the data and arguments important in a particular piece. And revision is totally normal! No one expects the first draft of a piece of writing to be ready for prime time. So write rough drafts and memos and notes to yourself and use them to think, and then revise them until the piece is the way you want it to be for sharing.

Bergin (2018) lays out a set of key concerns for appropriate writing about research. First, present your results accurately, without exaggerating or misrepresenting. It is very easy to overstate your findings by accident if you are enthusiastic about what you have found, so it is important to take care and use appropriate cautions about the limitations of the research. You also need to work to ensure that you communicate your findings in a way people can understand, using clear and appropriate language that is adjusted to the level of those you are communicating with. And you must be clear and transparent about the methodological strategies employed in the research. Remember, the goal is, as much as possible, to describe your research in a way that would permit others to replicate the study. There are a variety of other concerns and decision points that qualitative researchers must keep in mind, including the extent to which to include quantification in their presentation of results, ethics, considerations of audience and voice, and how to bring the richness of qualitative data to life.

Quantification, as you have learned, refers to the process of turning data into numbers. It can indeed be very useful to count and tabulate quantitative data drawn from qualitative research. For instance, if you were doing a study of dual-earner households and wanted to know how many had an equal division of household labor and how many did not, you might want to count those numbers up and include them as part of the final write-up. However, researchers need to take care when they are writing about quantified qualitative data. Qualitative data is not as generalizable as quantitative data, so quantification can be very misleading. Thus, qualitative researchers should strive to use raw numbers instead of the percentages that are more appropriate for quantitative research. Writing, for instance, “15 of the 20 people I interviewed prefer pancakes to waffles” is a simple description of the data; writing “75% of people prefer pancakes” suggests a generalizable claim that is not likely supported by the data. Note that mixing numbers with qualitative data is really a type of mixed-methods approach. Mixed-methods approaches are good, but sometimes they seduce researchers into focusing on the persuasive power of numbers and tables rather than capitalizing on the inherent richness of their qualitative data.

A variety of issues of scholarly ethics and research integrity are raised by the writing process. Some of these are unique to qualitative research, while others are more universal concerns for all academic and professional writing. For example, it is essential to avoid plagiarism and misuse of sources. All quotations that appear in a text must be properly cited, whether with in-text and bibliographic citations to the source or with an attribution to the research participant (or the participant’s pseudonym or description in order to protect confidentiality) who said those words. Where writers will paraphrase a text or a participant’s words, they need to make sure that the paraphrase they develop accurately reflects the meaning of the original words. Thus, some scholars suggest that participants should have the opportunity to read (or to have read to them, if they cannot read the text themselves) all sections of the text in which they, their words, or their ideas are presented to ensure accuracy and enable participants to maintain control over their lives.

Audience and Voice

When writing, researchers must consider their audience(s) and the effects they want their writing to have on these audiences. The designated audience will dictate the voice used in the writing, or the individual style and personality of a piece of text. Keep in mind that the potential audience for qualitative research is often much more diverse than that for quantitative research because of the accessibility of the data and the extent to which the writing can be accessible and interesting. Yet individual pieces of writing are typically pitched to a more specific subset of the audience.

Let us consider one potential research study, an ethnography involving participant-observation of the same children both when they are at daycare facility and when they are at home with their families to try to understand how daycare might impact behavior and social development. The findings of this study might be of interest to a wide variety of potential audiences: academic peers, whether at your own academic institution, in your broader discipline, or multidisciplinary; people responsible for creating laws and policies; practitioners who run or teach at day care centers; and the general public, including both people who are interested in child development more generally and those who are themselves parents making decisions about child care for their own children. And the way you write for each of these audiences will be somewhat different. Take a moment and think through what some of these differences might look like.

If you are writing to academic audiences, using specialized academic language and working within the typical constraints of scholarly genres, as will be discussed below, can be an important part of convincing others that your work is legitimate and should be taken seriously. Your writing will be formal. Even if you are writing for students and faculty you already know—your classmates, for instance—you are often asked to imitate the style of academic writing that is used in publications, as this is part of learning to become part of the scholarly conversation. When speaking to academic audiences outside your discipline, you may need to be more careful about jargon and specialized language, as disciplines do not always share the same key terms. For instance, in sociology, scholars use the term diffusion to refer to the way new ideas or practices spread from organization to organization. In the field of international relations, scholars often used the term cascade to refer to the way ideas or practices spread from nation to nation. These terms are describing what is fundamentally the same concept, but they are different terms—and a scholar from one field might have no idea what a scholar from a different field is talking about! Therefore, while the formality and academic structure of the text would stay the same, a writer with a multidisciplinary audience might need to pay more attention to defining their terms in the body of the text.

It is not only other academic scholars who expect to see formal writing. Policymakers tend to expect formality when ideas are presented to them, as well. However, the content and style of the writing will be different. Much less academic jargon should be used, and the most important findings and policy implications should be emphasized right from the start rather than initially focusing on prior literature and theoretical models as you might for an academic audience. Long discussions of research methods should also be minimized. Similarly, when you write for practitioners, the findings and implications for practice should be highlighted. The reading level of the text will vary depending on the typical background of the practitioners to whom you are writing—you can make very different assumptions about the general knowledge and reading abilities of a group of hospital medical directors with MDs than you can about a group of case workers who have a post-high-school certificate. Consider the primary language of your audience as well. The fact that someone can get by in spoken English does not mean they have the vocabulary or English reading skills to digest a complex report. But the fact that someone’s vocabulary is limited says little about their intellectual abilities, so try your best to convey the important complexity of the ideas and findings from your research without dumbing them down—even if you must limit your vocabulary usage.

When writing for the general public, you will want to move even further towards emphasizing key findings and policy implications, but you also want to draw on the most interesting aspects of your data. General readers will read sociological texts that are rich with ethnographic or other kinds of detail—it is almost like reality television on a page! And this is a contrast to busy policymakers and practitioners, who probably want to learn the main findings as quickly as possible so they can go about their busy lives. But also keep in mind that there is a wide variation in reading levels. Journalists at publications pegged to the general public are often advised to write at about a tenth-grade reading level, which would leave most of the specialized terminology we develop in our research fields out of reach. If you want to be accessible to even more people, your vocabulary must be even more limited. The excellent exercise of trying to write using the 1,000 most common English words, available at the Up-Goer Five website ( https://www.splasho.com/upgoer5/ ) does a good job of illustrating this challenge (Sanderson n.d.).

Another element of voice is whether to write in the first person. While many students are instructed to avoid the use of the first person in academic writing, this advice needs to be taken with a grain of salt. There are indeed many contexts in which the first person is best avoided, at least as long as writers can find ways to build strong, comprehensible sentences without its use, including most quantitative research writing. However, if the alternative to using the first person is crafting a sentence like “it is proposed that the researcher will conduct interviews,” it is preferable to write “I propose to conduct interviews.” In qualitative research, in fact, the use of the first person is far more common. This is because the researcher is central to the research project. Qualitative researchers can themselves be understood as research instruments, and thus eliminating the use of the first person in writing is in a sense eliminating information about the conduct of the researchers themselves.

But the question really extends beyond the issue of first-person or third-person. Qualitative researchers have choices about how and whether to foreground themselves in their writing, not just in terms of using the first person, but also in terms of whether to emphasize their own subjectivity and reflexivity, their impressions and ideas, and their role in the setting. In contrast, conventional quantitative research in the positivist tradition really tries to eliminate the author from the study—which indeed is exactly why typical quantitative research avoids the use of the first person. Keep in mind that emphasizing researchers’ roles and reflexivity and using the first person does not mean crafting articles that provide overwhelming detail about the author’s thoughts and practices. Readers do not need to hear, and should not be told, which database you used to search for journal articles, how many hours you spent transcribing, or whether the research process was stressful—save these things for the memos you write to yourself. Rather, readers need to hear how you interacted with research participants, how your standpoint may have shaped the findings, and what analytical procedures you carried out.

Making Data Come Alive

One of the most important parts of writing about qualitative research is presenting the data in a way that makes its richness and value accessible to readers. As the discussion of analysis in the prior chapter suggests, there are a variety of ways to do this. Researchers may select key quotes or images to illustrate points, write up specific case studies that exemplify their argument, or develop vignettes (little stories) that illustrate ideas and themes, all drawing directly on the research data. Researchers can also write more lengthy summaries, narratives, and thick descriptions.

Nearly all qualitative work includes quotes from research participants or documents to some extent, though ethnographic work may focus more on thick description than on relaying participants’ own words. When quotes are presented, they must be explained and interpreted—they cannot stand on their own. This is one of the ways in which qualitative research can be distinguished from journalism. Journalism presents what happened, but social science needs to present the “why,” and the why is best explained by the researcher.

So how do authors go about integrating quotes into their written work? Julie Posselt (2017), a sociologist who studies graduate education, provides a set of instructions. First of all, authors need to remain focused on the core questions of their research, and avoid getting distracted by quotes that are interesting or attention-grabbing but not so relevant to the research question. Selecting the right quotes, those that illustrate the ideas and arguments of the paper, is an important part of the writing process. Second, not all quotes should be the same length (just like not all sentences or paragraphs in a paper should be the same length). Include some quotes that are just phrases, others that are a sentence or so, and others that are longer. We call longer quotes, generally those more than about three lines long, block quotes , and they are typically indented on both sides to set them off from the surrounding text. For all quotes, be sure to summarize what the quote should be telling or showing the reader, connect this quote to other quotes that are similar or different, and provide transitions in the discussion to move from quote to quote and from topic to topic. Especially for longer quotes, it is helpful to do some of this writing before the quote to preview what is coming and other writing after the quote to make clear what readers should have come to understand. Remember, it is always the author’s job to interpret the data. Presenting excerpts of the data, like quotes, in a form the reader can access does not minimize the importance of this job. Be sure that you are explaining the meaning of the data you present.

A few more notes about writing with quotes: avoid patchwriting, whether in your literature review or the section of your paper in which quotes from respondents are presented. Patchwriting is a writing practice wherein the author lightly paraphrases original texts but stays so close to those texts that there is little the author has added. Sometimes, this even takes the form of presenting a series of quotes, properly documented, with nothing much in the way of text generated by the author. A patchwriting approach does not build the scholarly conversation forward, as it does not represent any kind of new contribution on the part of the author. It is of course fine to paraphrase quotes, as long as the meaning is not changed. But if you use direct quotes, do not edit the text of the quotes unless how you edit them does not change the meaning and you have made clear through the use of ellipses (…) and brackets ([])what kinds of edits have been made. For example, consider this exchange from Matthew Desmond’s (2012:1317) research on evictions:

The thing was, I wasn’t never gonna let Crystal come and stay with me from the get go. I just told her that to throw her off. And she wasn’t fittin’ to come stay with me with no money…No. Nope. You might as well stay in that shelter.

A paraphrase of this exchange might read “She said that she was going to let Crystal stay with her if Crystal did not have any money.” Paraphrases like that are fine. What is not fine is rewording the statement but treating it like a quote, for instance writing:

The thing was, I was not going to let Crystal come and stay with me from beginning. I just told her that to throw her off. And it was not proper for her to come stay with me without any money…No. Nope. You might as well stay in that shelter.

But as you can see, the change in language and style removes some of the distinct meaning of the original quote. Instead, writers should leave as much of the original language as possible. If some text in the middle of the quote needs to be removed, as in this example, ellipses are used to show that this has occurred. And if a word needs to be added to clarify, it is placed in square brackets to show that it was not part of the original quote.

Data can also be presented through the use of data displays like tables, charts, graphs, diagrams, and infographics created for publication or presentation, as well as through the use of visual material collected during the research process. Note that if visuals are used, the author must have the legal right to use them. Photographs or diagrams created by the author themselves—or by research participants who have signed consent forms for their work to be used, are fine. But photographs, and sometimes even excerpts from archival documents, may be owned by others from whom researchers must get permission in order to use them.

A large percentage of qualitative research does not include any data displays or visualizations. Therefore, researchers should carefully consider whether the use of data displays will help the reader understand the data. One of the most common types of data displays used by qualitative researchers are simple tables. These might include tables summarizing key data about cases included in the study; tables laying out the characteristics of different taxonomic elements or types developed as part of the analysis; tables counting the incidence of various elements; and 2×2 tables (two columns and two rows) illuminating a theory. Basic network or process diagrams are also commonly included. If data displays are used, it is essential that researchers include context and analysis alongside data displays rather than letting them stand by themselves, and it is preferable to continue to present excerpts and examples from the data rather than just relying on summaries in the tables.

If you will be using graphs, infographics, or other data visualizations, it is important that you attend to making them useful and accurate (Bergin 2018). Think about the viewer or user as your audience and ensure the data visualizations will be comprehensible. You may need to include more detail or labels than you might think. Ensure that data visualizations are laid out and labeled clearly and that you make visual choices that enhance viewers’ ability to understand the points you intend to communicate using the visual in question. Finally, given the ease with which it is possible to design visuals that are deceptive or misleading, it is essential to make ethical and responsible choices in the construction of visualization so that viewers will interpret them in accurate ways.

The Genre of Research Writing

As discussed above, the style and format in which results are presented depends on the audience they are intended for. These differences in styles and format are part of the genre of writing. Genre is a term referring to the rules of a specific form of creative or productive work. Thus, the academic journal article—and student papers based on this form—is one genre. A report or policy paper is another. The discussion below will focus on the academic journal article, but note that reports and policy papers follow somewhat different formats. They might begin with an executive summary of one or a few pages, include minimal background, focus on key findings, and conclude with policy implications, shifting methods and details about the data to an appendix. But both academic journal articles and policy papers share some things in common, for instance the necessity for clear writing, a well-organized structure, and the use of headings.

So what factors make up the genre of the academic journal article in sociology? While there is some flexibility, particularly for ethnographic work, academic journal articles tend to follow a fairly standard format. They begin with a “title page” that includes the article title (often witty and involving scholarly inside jokes, but more importantly clearly describing the content of the article); the authors’ names and institutional affiliations, an abstract , and sometimes keywords designed to help others find the article in databases. An abstract is a short summary of the article that appears both at the very beginning of the article and in search databases. Abstracts are designed to aid readers by giving them the opportunity to learn enough about an article that they can determine whether it is worth their time to read the complete text. They are written about the article, and thus not in the first person, and clearly summarize the research question, methodological approach, main findings, and often the implications of the research.

After the abstract comes an “introduction” of a page or two that details the research question, why it matters, and what approach the paper will take. This is followed by a literature review of about a quarter to a third the length of the entire paper. The literature review is often divided, with headings, into topical subsections, and is designed to provide a clear, thorough overview of the prior research literature on which a paper has built—including prior literature the new paper contradicts. At the end of the literature review it should be made clear what researchers know about the research topic and question, what they do not know, and what this new paper aims to do to address what is not known.

The next major section of the paper is the section that describes research design, data collection, and data analysis, often referred to as “research methods” or “methodology.” This section is an essential part of any written or oral presentation of your research. Here, you tell your readers or listeners “how you collected and interpreted your data” (Taylor, Bogdan, and DeVault 2016:215). Taylor, Bogdan, and DeVault suggest that the discussion of your research methods include the following:

• The particular approach to data collection used in the study;
• Any theoretical perspective(s) that shaped your data collection and analytical approach;
• When the study occurred, over how long, and where (concealing identifiable details as needed);
• A description of the setting and participants, including sampling and selection criteria (if an interview-based study, the number of participants should be clearly stated);
• The researcher’s perspective in carrying out the study, including relevant elements of their identity and standpoint, as well as their role (if any) in research settings; and
• The approach to analyzing the data.

After the methods section comes a section, variously titled but often called “data,” that takes readers through the analysis. This section is where the thick description narrative; the quotes, broken up by theme or topic, with their interpretation; the discussions of case studies; most data displays (other than perhaps those outlining a theoretical model or summarizing descriptive data about cases); and other similar material appears. The idea of the data section is to give readers the ability to see the data for themselves and to understand how this data supports the ultimate conclusions. Note that all tables and figures included in formal publications should be titled and numbered.

At the end of the paper come one or two summary sections, often called “discussion” and/or “conclusion.” If there is a separate discussion section, it will focus on exploring the overall themes and findings of the paper. The conclusion clearly and succinctly summarizes the findings and conclusions of the paper, the limitations of the research and analysis, any suggestions for future research building on the paper or addressing these limitations, and implications, be they for scholarship and theory or policy and practice.

After the end of the textual material in the paper comes the bibliography, typically called “works cited” or “references.” The references should appear in a consistent citation style—in sociology, we often use the American Sociological Association format (American Sociological Association 2019), but other formats may be used depending on where the piece will eventually be published. Care should be taken to ensure that in-text citations also reflect the chosen citation style. In some papers, there may be an appendix containing supplemental information such as a list of interview questions or an additional data visualization.

Note that when researchers give presentations to scholarly audiences, the presentations typically follow a format similar to that of scholarly papers, though given time limitations they are compressed. Abstracts and works cited are often not part of the presentation, though in-text citations are still used. The literature review presented will be shortened to only focus on the most important aspects of the prior literature, and only key examples from the discussion of data will be included. For long or complex papers, sometimes only one of several findings is the focus of the presentation. Of course, presentations for other audiences may be constructed differently, with greater attention to interesting elements of the data and findings as well as implications and less to the literature review and methods.

Concluding Your Work

After you have written a complete draft of the paper, be sure you take the time to revise and edit your work. There are several important strategies for revision. First, put your work away for a little while. Even waiting a day to revise is better than nothing, but it is best, if possible, to take much more time away from the text. This helps you forget what your writing looks like and makes it easier to find errors, mistakes, and omissions. Second, show your work to others. Ask them to read your work and critique it, pointing out places where the argument is weak, where you may have overlooked alternative explanations, where the writing could be improved, and what else you need to work on. Finally, read your work out loud to yourself (or, if you really need an audience, try reading to some stuffed animals). Reading out loud helps you catch wrong words, tricky sentences, and many other issues. But as important as revision is, try to avoid perfectionism in writing (Warren and Karner 2015). Writing can always be improved, no matter how much time you spend on it. Those improvements, however, have diminishing returns, and at some point the writing process needs to conclude so the writing can be shared with the world.

Of course, the main goal of writing up the results of a research project is to share with others. Thus, researchers should be considering how they intend to disseminate their results. What conferences might be appropriate? Where can the paper be submitted? Note that if you are an undergraduate student, there are a wide variety of journals that accept and publish research conducted by undergraduates. Some publish across disciplines, while others are specific to disciplines. Other work, such as reports, may be best disseminated by publication online on relevant organizational websites.

After a project is completed, be sure to take some time to organize your research materials and archive them for longer-term storage. Some Institutional Review Board (IRB) protocols require that original data, such as interview recordings, transcripts, and field notes, be preserved for a specific number of years in a protected (locked for paper or password-protected for digital) form and then destroyed, so be sure that your plans adhere to the IRB requirements. Be sure you keep any materials that might be relevant for future related research or for answering questions people may ask later about your project.

And then what? Well, then it is time to move on to your next research project. Research is a long-term endeavor, not a one-time-only activity. We build our skills and our expertise as we continue to pursue research. So keep at it.

• Find a short article that uses qualitative methods. The sociological magazine Contexts is a good place to find such pieces. Write an abstract of the article.
• Choose a sociological journal article on a topic you are interested in that uses some form of qualitative methods and is at least 20 pages long. Rewrite the article as a five-page research summary accessible to non-scholarly audiences.
• Choose a concept or idea you have learned in this course and write an explanation of it using the Up-Goer Five Text Editor ( https://www.splasho.com/upgoer5/ ), a website that restricts your writing to the 1,000 most common English words. What was this experience like? What did it teach you about communicating with people who have a more limited English-language vocabulary—and what did it teach you about the utility of having access to complex academic language?
• Select five or more sociological journal articles that all use the same basic type of qualitative methods (interviewing, ethnography, documents, or visual sociology). Using what you have learned about coding, code the methods sections of each article, and use your coding to figure out what is common in how such articles discuss their research design, data collection, and analysis methods.
• Return to an exercise you completed earlier in this course and revise your work. What did you change? How did revising impact the final product?
• Find a quote from the transcript of an interview, a social media post, or elsewhere that has not yet been interpreted or explained. Write a paragraph that includes the quote along with an explanation of its sociological meaning or significance.

The style or personality of a piece of writing, including such elements as tone, word choice, syntax, and rhythm.

A quotation, usually one of some length, which is set off from the main text by being indented on both sides rather than being placed in quotation marks.

A classification of written or artistic work based on form, content, and style.

A short summary of a text written from the perspective of a reader rather than from the perspective of an author.

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• v.74(8); 2010 Oct 11

Presenting and Evaluating Qualitative Research

The purpose of this paper is to help authors to think about ways to present qualitative research papers in the American Journal of Pharmaceutical Education . It also discusses methods for reviewers to assess the rigour, quality, and usefulness of qualitative research. Examples of different ways to present data from interviews, observations, and focus groups are included. The paper concludes with guidance for publishing qualitative research and a checklist for authors and reviewers.

INTRODUCTION

Policy and practice decisions, including those in education, increasingly are informed by findings from qualitative as well as quantitative research. Qualitative research is useful to policymakers because it often describes the settings in which policies will be implemented. Qualitative research is also useful to both pharmacy practitioners and pharmacy academics who are involved in researching educational issues in both universities and practice and in developing teaching and learning.

Qualitative research involves the collection, analysis, and interpretation of data that are not easily reduced to numbers. These data relate to the social world and the concepts and behaviors of people within it. Qualitative research can be found in all social sciences and in the applied fields that derive from them, for example, research in health services, nursing, and pharmacy. 1 It looks at X in terms of how X varies in different circumstances rather than how big is X or how many Xs are there? 2 Textbooks often subdivide research into qualitative and quantitative approaches, furthering the common assumption that there are fundamental differences between the 2 approaches. With pharmacy educators who have been trained in the natural and clinical sciences, there is often a tendency to embrace quantitative research, perhaps due to familiarity. A growing consensus is emerging that sees both qualitative and quantitative approaches as useful to answering research questions and understanding the world. Increasingly mixed methods research is being carried out where the researcher explicitly combines the quantitative and qualitative aspects of the study. 3 , 4

Like healthcare, education involves complex human interactions that can rarely be studied or explained in simple terms. Complex educational situations demand complex understanding; thus, the scope of educational research can be extended by the use of qualitative methods. Qualitative research can sometimes provide a better understanding of the nature of educational problems and thus add to insights into teaching and learning in a number of contexts. For example, at the University of Nottingham, we conducted in-depth interviews with pharmacists to determine their perceptions of continuing professional development and who had influenced their learning. We also have used a case study approach using observation of practice and in-depth interviews to explore physiotherapists' views of influences on their leaning in practice. We have conducted in-depth interviews with a variety of stakeholders in Malawi, Africa, to explore the issues surrounding pharmacy academic capacity building. A colleague has interviewed and conducted focus groups with students to explore cultural issues as part of a joint Nottingham-Malaysia pharmacy degree program. Another colleague has interviewed pharmacists and patients regarding their expectations before and after clinic appointments and then observed pharmacist-patient communication in clinics and assessed it using the Calgary Cambridge model in order to develop recommendations for communication skills training. 5 We have also performed documentary analysis on curriculum data to compare pharmacist and nurse supplementary prescribing courses in the United Kingdom.

It is important to choose the most appropriate methods for what is being investigated. Qualitative research is not appropriate to answer every research question and researchers need to think carefully about their objectives. Do they wish to study a particular phenomenon in depth (eg, students' perceptions of studying in a different culture)? Or are they more interested in making standardized comparisons and accounting for variance (eg, examining differences in examination grades after changing the way the content of a module is taught). Clearly a quantitative approach would be more appropriate in the last example. As with any research project, a clear research objective has to be identified to know which methods should be applied.

Types of qualitative data include:

• Audio recordings and transcripts from in-depth or semi-structured interviews
• Structured interview questionnaires containing substantial open comments including a substantial number of responses to open comment items.
• Audio recordings and transcripts from focus group sessions.
• Field notes (notes taken by the researcher while in the field [setting] being studied)
• Video recordings (eg, lecture delivery, class assignments, laboratory performance)
• Case study notes
• Documents (reports, meeting minutes, e-mails)
• Diaries, video diaries
• Observation notes
• Press clippings
• Photographs

RIGOUR IN QUALITATIVE RESEARCH

Qualitative research is often criticized as biased, small scale, anecdotal, and/or lacking rigor; however, when it is carried out properly it is unbiased, in depth, valid, reliable, credible and rigorous. In qualitative research, there needs to be a way of assessing the “extent to which claims are supported by convincing evidence.” 1 Although the terms reliability and validity traditionally have been associated with quantitative research, increasingly they are being seen as important concepts in qualitative research as well. Examining the data for reliability and validity assesses both the objectivity and credibility of the research. Validity relates to the honesty and genuineness of the research data, while reliability relates to the reproducibility and stability of the data.

The validity of research findings refers to the extent to which the findings are an accurate representation of the phenomena they are intended to represent. The reliability of a study refers to the reproducibility of the findings. Validity can be substantiated by a number of techniques including triangulation use of contradictory evidence, respondent validation, and constant comparison. Triangulation is using 2 or more methods to study the same phenomenon. Contradictory evidence, often known as deviant cases, must be sought out, examined, and accounted for in the analysis to ensure that researcher bias does not interfere with or alter their perception of the data and any insights offered. Respondent validation, which is allowing participants to read through the data and analyses and provide feedback on the researchers' interpretations of their responses, provides researchers with a method of checking for inconsistencies, challenges the researchers' assumptions, and provides them with an opportunity to re-analyze their data. The use of constant comparison means that one piece of data (for example, an interview) is compared with previous data and not considered on its own, enabling researchers to treat the data as a whole rather than fragmenting it. Constant comparison also enables the researcher to identify emerging/unanticipated themes within the research project.

STRENGTHS AND LIMITATIONS OF QUALITATIVE RESEARCH

Qualitative researchers have been criticized for overusing interviews and focus groups at the expense of other methods such as ethnography, observation, documentary analysis, case studies, and conversational analysis. Qualitative research has numerous strengths when properly conducted.

Strengths of Qualitative Research

• Issues can be examined in detail and in depth.
• Interviews are not restricted to specific questions and can be guided/redirected by the researcher in real time.
• The research framework and direction can be quickly revised as new information emerges.
• The data based on human experience that is obtained is powerful and sometimes more compelling than quantitative data.
• Subtleties and complexities about the research subjects and/or topic are discovered that are often missed by more positivistic enquiries.
• Data usually are collected from a few cases or individuals so findings cannot be generalized to a larger population. Findings can however be transferable to another setting.

Limitations of Qualitative Research

• Research quality is heavily dependent on the individual skills of the researcher and more easily influenced by the researcher's personal biases and idiosyncrasies.
• Rigor is more difficult to maintain, assess, and demonstrate.
• The volume of data makes analysis and interpretation time consuming.
• It is sometimes not as well understood and accepted as quantitative research within the scientific community
• The researcher's presence during data gathering, which is often unavoidable in qualitative research, can affect the subjects' responses.
• Issues of anonymity and confidentiality can present problems when presenting findings
• Findings can be more difficult and time consuming to characterize in a visual way.

PRESENTATION OF QUALITATIVE RESEARCH FINDINGS

The following extracts are examples of how qualitative data might be presented:

Data From an Interview.

The following is an example of how to present and discuss a quote from an interview.

The researcher should select quotes that are poignant and/or most representative of the research findings. Including large portions of an interview in a research paper is not necessary and often tedious for the reader. The setting and speakers should be established in the text at the end of the quote.

The student describes how he had used deep learning in a dispensing module. He was able to draw on learning from a previous module, “I found that while using the e learning programme I was able to apply the knowledge and skills that I had gained in last year's diseases and goals of treatment module.” (interviewee 22, male)

This is an excerpt from an article on curriculum reform that used interviews 5 :

The first question was, “Without the accreditation mandate, how much of this curriculum reform would have been attempted?” According to respondents, accreditation played a significant role in prompting the broad-based curricular change, and their comments revealed a nuanced view. Most indicated that the change would likely have occurred even without the mandate from the accreditation process: “It reflects where the profession wants to be … training a professional who wants to take on more responsibility.” However, they also commented that “if it were not mandated, it could have been a very difficult road.” Or it “would have happened, but much later.” The change would more likely have been incremental, “evolutionary,” or far more limited in its scope. “Accreditation tipped the balance” was the way one person phrased it. “Nobody got serious until the accrediting body said it would no longer accredit programs that did not change.”

Data From Observations

The following example is some data taken from observation of pharmacist patient consultations using the Calgary Cambridge guide. 6 , 7 The data are first presented and a discussion follows:

Pharmacist: We will soon be starting a stop smoking clinic. Patient: Is the interview over now? Pharmacist: No this is part of it. (Laughs) You can't tell me to bog off (sic) yet. (pause) We will be starting a stop smoking service here, Patient: Yes. Pharmacist: with one-to-one and we will be able to help you or try to help you. If you want it. In this example, the pharmacist has picked up from the patient's reaction to the stop smoking clinic that she is not receptive to advice about giving up smoking at this time; in fact she would rather end the consultation. The pharmacist draws on his prior relationship with the patient and makes use of a joke to lighten the tone. He feels his message is important enough to persevere but he presents the information in a succinct and non-pressurised way. His final comment of “If you want it” is important as this makes it clear that he is not putting any pressure on the patient to take up this offer. This extract shows that some patient cues were picked up, and appropriately dealt with, but this was not the case in all examples.

Data From Focus Groups

This excerpt from a study involving 11 focus groups illustrates how findings are presented using representative quotes from focus group participants. 8

Those pharmacists who were initially familiar with CPD endorsed the model for their peers, and suggested it had made a meaningful difference in the way they viewed their own practice. In virtually all focus groups sessions, pharmacists familiar with and supportive of the CPD paradigm had worked in collaborative practice environments such as hospital pharmacy practice. For these pharmacists, the major advantage of CPD was the linking of workplace learning with continuous education. One pharmacist stated, “It's amazing how much I have to learn every day, when I work as a pharmacist. With [the learning portfolio] it helps to show how much learning we all do, every day. It's kind of satisfying to look it over and see how much you accomplish.” Within many of the learning portfolio-sharing sessions, debates emerged regarding the true value of traditional continuing education and its outcome in changing an individual's practice. While participants appreciated the opportunity for social and professional networking inherent in some forms of traditional CE, most eventually conceded that the academic value of most CE programming was limited by the lack of a systematic process for following-up and implementing new learning in the workplace. “Well it's nice to go to these [continuing education] events, but really, I don't know how useful they are. You go, you sit, you listen, but then, well I at least forget.”

The following is an extract from a focus group (conducted by the author) with first-year pharmacy students about community placements. It illustrates how focus groups provide a chance for participants to discuss issues on which they might disagree.

Interviewer: So you are saying that you would prefer health related placements? Student 1: Not exactly so long as I could be developing my communication skill. Student 2: Yes but I still think the more health related the placement is the more I'll gain from it. Student 3: I disagree because other people related skills are useful and you may learn those from taking part in a community project like building a garden. Interviewer: So would you prefer a mixture of health and non health related community placements?

GUIDANCE FOR PUBLISHING QUALITATIVE RESEARCH

Qualitative research is becoming increasingly accepted and published in pharmacy and medical journals. Some journals and publishers have guidelines for presenting qualitative research, for example, the British Medical Journal 9 and Biomedcentral . 10 Medical Education published a useful series of articles on qualitative research. 11 Some of the important issues that should be considered by authors, reviewers and editors when publishing qualitative research are discussed below.

Introduction.

A good introduction provides a brief overview of the manuscript, including the research question and a statement justifying the research question and the reasons for using qualitative research methods. This section also should provide background information, including relevant literature from pharmacy, medicine, and other health professions, as well as literature from the field of education that addresses similar issues. Any specific educational or research terminology used in the manuscript should be defined in the introduction.

The methods section should clearly state and justify why the particular method, for example, face to face semistructured interviews, was chosen. The method should be outlined and illustrated with examples such as the interview questions, focusing exercises, observation criteria, etc. The criteria for selecting the study participants should then be explained and justified. The way in which the participants were recruited and by whom also must be stated. A brief explanation/description should be included of those who were invited to participate but chose not to. It is important to consider “fair dealing,” ie, whether the research design explicitly incorporates a wide range of different perspectives so that the viewpoint of 1 group is never presented as if it represents the sole truth about any situation. The process by which ethical and or research/institutional governance approval was obtained should be described and cited.

The study sample and the research setting should be described. Sampling differs between qualitative and quantitative studies. In quantitative survey studies, it is important to select probability samples so that statistics can be used to provide generalizations to the population from which the sample was drawn. Qualitative research necessitates having a small sample because of the detailed and intensive work required for the study. So sample sizes are not calculated using mathematical rules and probability statistics are not applied. Instead qualitative researchers should describe their sample in terms of characteristics and relevance to the wider population. Purposive sampling is common in qualitative research. Particular individuals are chosen with characteristics relevant to the study who are thought will be most informative. Purposive sampling also may be used to produce maximum variation within a sample. Participants being chosen based for example, on year of study, gender, place of work, etc. Representative samples also may be used, for example, 20 students from each of 6 schools of pharmacy. Convenience samples involve the researcher choosing those who are either most accessible or most willing to take part. This may be fine for exploratory studies; however, this form of sampling may be biased and unrepresentative of the population in question. Theoretical sampling uses insights gained from previous research to inform sample selection for a new study. The method for gaining informed consent from the participants should be described, as well as how anonymity and confidentiality of subjects were guaranteed. The method of recording, eg, audio or video recording, should be noted, along with procedures used for transcribing the data.

Data Analysis.

A description of how the data were analyzed also should be included. Was computer-aided qualitative data analysis software such as NVivo (QSR International, Cambridge, MA) used? Arrival at “data saturation” or the end of data collection should then be described and justified. A good rule when considering how much information to include is that readers should have been given enough information to be able to carry out similar research themselves.

One of the strengths of qualitative research is the recognition that data must always be understood in relation to the context of their production. 1 The analytical approach taken should be described in detail and theoretically justified in light of the research question. If the analysis was repeated by more than 1 researcher to ensure reliability or trustworthiness, this should be stated and methods of resolving any disagreements clearly described. Some researchers ask participants to check the data. If this was done, it should be fully discussed in the paper.

An adequate account of how the findings were produced should be included A description of how the themes and concepts were derived from the data also should be included. Was an inductive or deductive process used? The analysis should not be limited to just those issues that the researcher thinks are important, anticipated themes, but also consider issues that participants raised, ie, emergent themes. Qualitative researchers must be open regarding the data analysis and provide evidence of their thinking, for example, were alternative explanations for the data considered and dismissed, and if so, why were they dismissed? It also is important to present outlying or negative/deviant cases that did not fit with the central interpretation.

The interpretation should usually be grounded in interviewees or respondents' contributions and may be semi-quantified, if this is possible or appropriate, for example, “Half of the respondents said …” “The majority said …” “Three said…” Readers should be presented with data that enable them to “see what the researcher is talking about.” 1 Sufficient data should be presented to allow the reader to clearly see the relationship between the data and the interpretation of the data. Qualitative data conventionally are presented by using illustrative quotes. Quotes are “raw data” and should be compiled and analyzed, not just listed. There should be an explanation of how the quotes were chosen and how they are labeled. For example, have pseudonyms been given to each respondent or are the respondents identified using codes, and if so, how? It is important for the reader to be able to see that a range of participants have contributed to the data and that not all the quotes are drawn from 1 or 2 individuals. There is a tendency for authors to overuse quotes and for papers to be dominated by a series of long quotes with little analysis or discussion. This should be avoided.

Participants do not always state the truth and may say what they think the interviewer wishes to hear. A good qualitative researcher should not only examine what people say but also consider how they structured their responses and how they talked about the subject being discussed, for example, the person's emotions, tone, nonverbal communication, etc. If the research was triangulated with other qualitative or quantitative data, this should be discussed.

Discussion.

The findings should be presented in the context of any similar previous research and or theories. A discussion of the existing literature and how this present research contributes to the area should be included. A consideration must also be made about how transferrable the research would be to other settings. Any particular strengths and limitations of the research also should be discussed. It is common practice to include some discussion within the results section of qualitative research and follow with a concluding discussion.

The author also should reflect on their own influence on the data, including a consideration of how the researcher(s) may have introduced bias to the results. The researcher should critically examine their own influence on the design and development of the research, as well as on data collection and interpretation of the data, eg, were they an experienced teacher who researched teaching methods? If so, they should discuss how this might have influenced their interpretation of the results.

Conclusion.

The conclusion should summarize the main findings from the study and emphasize what the study adds to knowledge in the area being studied. Mays and Pope suggest the researcher ask the following 3 questions to determine whether the conclusions of a qualitative study are valid 12 : How well does this analysis explain why people behave in the way they do? How comprehensible would this explanation be to a thoughtful participant in the setting? How well does the explanation cohere with what we already know?

CHECKLIST FOR QUALITATIVE PAPERS

This paper establishes criteria for judging the quality of qualitative research. It provides guidance for authors and reviewers to prepare and review qualitative research papers for the American Journal of Pharmaceutical Education . A checklist is provided in Appendix 1 to assist both authors and reviewers of qualitative data.

ACKNOWLEDGEMENTS

Thank you to the 3 reviewers whose ideas helped me to shape this paper.

Appendix 1. Checklist for authors and reviewers of qualitative research.

Introduction

• □ Research question is clearly stated.
• □ Research question is justified and related to the existing knowledge base (empirical research, theory, policy).
• □ Any specific research or educational terminology used later in manuscript is defined.
• □ The process by which ethical and or research/institutional governance approval was obtained is described and cited.
• □ Reason for choosing particular research method is stated.
• □ Criteria for selecting study participants are explained and justified.
• □ Recruitment methods are explicitly stated.
• □ Details of who chose not to participate and why are given.
• □ Study sample and research setting used are described.
• □ Method for gaining informed consent from the participants is described.
• □ Maintenance/Preservation of subject anonymity and confidentiality is described.
• □ Method of recording data (eg, audio or video recording) and procedures for transcribing data are described.
• □ Methods are outlined and examples given (eg, interview guide).
• □ Decision to stop data collection is described and justified.
• □ Data analysis and verification are described, including by whom they were performed.
• □ Methods for identifying/extrapolating themes and concepts from the data are discussed.
• □ Sufficient data are presented to allow a reader to assess whether or not the interpretation is supported by the data.
• □ Outlying or negative/deviant cases that do not fit with the central interpretation are presented.
• □ Transferability of research findings to other settings is discussed.
• □ Findings are presented in the context of any similar previous research and social theories.
• □ Discussion often is incorporated into the results in qualitative papers.
• □ A discussion of the existing literature and how this present research contributes to the area is included.
• □ Any particular strengths and limitations of the research are discussed.
• □ Reflection of the influence of the researcher(s) on the data, including a consideration of how the researcher(s) may have introduced bias to the results is included.

Conclusions

• □ The conclusion states the main finings of the study and emphasizes what the study adds to knowledge in the subject area.