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How to Write Recommendations in Research | Examples & Tips

Published on September 15, 2022 by Tegan George . Revised on July 18, 2023.

Recommendations in research are a crucial component of your discussion section and the conclusion of your thesis , dissertation , or research paper .

As you conduct your research and analyze the data you collected , perhaps there are ideas or results that don’t quite fit the scope of your research topic. Or, maybe your results suggest that there are further implications of your results or the causal relationships between previously-studied variables than covered in extant research.

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Table of contents

What should recommendations look like, building your research recommendation, how should your recommendations be written, recommendation in research example, other interesting articles, frequently asked questions about recommendations.

Recommendations for future research should be:

  • Concrete and specific
  • Supported with a clear rationale
  • Directly connected to your research

Overall, strive to highlight ways other researchers can reproduce or replicate your results to draw further conclusions, and suggest different directions that future research can take, if applicable.

Relatedly, when making these recommendations, avoid:

  • Undermining your own work, but rather offer suggestions on how future studies can build upon it
  • Suggesting recommendations actually needed to complete your argument, but rather ensure that your research stands alone on its own merits
  • Using recommendations as a place for self-criticism, but rather as a natural extension point for your work

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conclusion and recommendation in research meaning

There are many different ways to frame recommendations, but the easiest is perhaps to follow the formula of research question   conclusion  recommendation. Here’s an example.

Conclusion An important condition for controlling many social skills is mastering language. If children have a better command of language, they can express themselves better and are better able to understand their peers. Opportunities to practice social skills are thus dependent on the development of language skills.

As a rule of thumb, try to limit yourself to only the most relevant future recommendations: ones that stem directly from your work. While you can have multiple recommendations for each research conclusion, it is also acceptable to have one recommendation that is connected to more than one conclusion.

These recommendations should be targeted at your audience, specifically toward peers or colleagues in your field that work on similar subjects to your paper or dissertation topic . They can flow directly from any limitations you found while conducting your work, offering concrete and actionable possibilities for how future research can build on anything that your own work was unable to address at the time of your writing.

See below for a full research recommendation example that you can use as a template to write your own.

Recommendation in research example

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While it may be tempting to present new arguments or evidence in your thesis or disseration conclusion , especially if you have a particularly striking argument you’d like to finish your analysis with, you shouldn’t. Theses and dissertations follow a more formal structure than this.

All your findings and arguments should be presented in the body of the text (more specifically in the discussion section and results section .) The conclusion is meant to summarize and reflect on the evidence and arguments you have already presented, not introduce new ones.

The conclusion of your thesis or dissertation should include the following:

  • A restatement of your research question
  • A summary of your key arguments and/or results
  • A short discussion of the implications of your research

For a stronger dissertation conclusion , avoid including:

  • Important evidence or analysis that wasn’t mentioned in the discussion section and results section
  • Generic concluding phrases (e.g. “In conclusion …”)
  • Weak statements that undermine your argument (e.g., “There are good points on both sides of this issue.”)

Your conclusion should leave the reader with a strong, decisive impression of your work.

In a thesis or dissertation, the discussion is an in-depth exploration of the results, going into detail about the meaning of your findings and citing relevant sources to put them in context.

The conclusion is more shorter and more general: it concisely answers your main research question and makes recommendations based on your overall findings.

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How to Write a Conclusion for Research Papers (with Examples)

How to Write a Conclusion for Research Papers (with Examples)

The conclusion of a research paper is a crucial section that plays a significant role in the overall impact and effectiveness of your research paper. However, this is also the section that typically receives less attention compared to the introduction and the body of the paper. The conclusion serves to provide a concise summary of the key findings, their significance, their implications, and a sense of closure to the study. Discussing how can the findings be applied in real-world scenarios or inform policy, practice, or decision-making is especially valuable to practitioners and policymakers. The research paper conclusion also provides researchers with clear insights and valuable information for their own work, which they can then build on and contribute to the advancement of knowledge in the field.

The research paper conclusion should explain the significance of your findings within the broader context of your field. It restates how your results contribute to the existing body of knowledge and whether they confirm or challenge existing theories or hypotheses. Also, by identifying unanswered questions or areas requiring further investigation, your awareness of the broader research landscape can be demonstrated.

Remember to tailor the research paper conclusion to the specific needs and interests of your intended audience, which may include researchers, practitioners, policymakers, or a combination of these.

Table of Contents

What is a conclusion in a research paper, summarizing conclusion, editorial conclusion, externalizing conclusion, importance of a good research paper conclusion, how to write a conclusion for your research paper, research paper conclusion examples, frequently asked questions.

A conclusion in a research paper is the final section where you summarize and wrap up your research, presenting the key findings and insights derived from your study. The research paper conclusion is not the place to introduce new information or data that was not discussed in the main body of the paper. When working on how to conclude a research paper, remember to stick to summarizing and interpreting existing content. The research paper conclusion serves the following purposes: 1

  • Warn readers of the possible consequences of not attending to the problem.
  • Recommend specific course(s) of action.
  • Restate key ideas to drive home the ultimate point of your research paper.
  • Provide a “take-home” message that you want the readers to remember about your study.

conclusion and recommendation in research meaning

Types of conclusions for research papers

In research papers, the conclusion provides closure to the reader. The type of research paper conclusion you choose depends on the nature of your study, your goals, and your target audience. I provide you with three common types of conclusions:

A summarizing conclusion is the most common type of conclusion in research papers. It involves summarizing the main points, reiterating the research question, and restating the significance of the findings. This common type of research paper conclusion is used across different disciplines.

An editorial conclusion is less common but can be used in research papers that are focused on proposing or advocating for a particular viewpoint or policy. It involves presenting a strong editorial or opinion based on the research findings and offering recommendations or calls to action.

An externalizing conclusion is a type of conclusion that extends the research beyond the scope of the paper by suggesting potential future research directions or discussing the broader implications of the findings. This type of conclusion is often used in more theoretical or exploratory research papers.

The conclusion in a research paper serves several important purposes:

  • Offers Implications and Recommendations : Your research paper conclusion is an excellent place to discuss the broader implications of your research and suggest potential areas for further study. It’s also an opportunity to offer practical recommendations based on your findings.
  • Provides Closure : A good research paper conclusion provides a sense of closure to your paper. It should leave the reader with a feeling that they have reached the end of a well-structured and thought-provoking research project.
  • Leaves a Lasting Impression : Writing a well-crafted research paper conclusion leaves a lasting impression on your readers. It’s your final opportunity to leave them with a new idea, a call to action, or a memorable quote.

conclusion and recommendation in research meaning

Writing a strong conclusion for your research paper is essential to leave a lasting impression on your readers. Here’s a step-by-step process to help you create and know what to put in the conclusion of a research paper: 2

  • Research Statement : Begin your research paper conclusion by restating your research statement. This reminds the reader of the main point you’ve been trying to prove throughout your paper. Keep it concise and clear.
  • Key Points : Summarize the main arguments and key points you’ve made in your paper. Avoid introducing new information in the research paper conclusion. Instead, provide a concise overview of what you’ve discussed in the body of your paper.
  • Address the Research Questions : If your research paper is based on specific research questions or hypotheses, briefly address whether you’ve answered them or achieved your research goals. Discuss the significance of your findings in this context.
  • Significance : Highlight the importance of your research and its relevance in the broader context. Explain why your findings matter and how they contribute to the existing knowledge in your field.
  • Implications : Explore the practical or theoretical implications of your research. How might your findings impact future research, policy, or real-world applications? Consider the “so what?” question.
  • Future Research : Offer suggestions for future research in your area. What questions or aspects remain unanswered or warrant further investigation? This shows that your work opens the door for future exploration.
  • Closing Thought : Conclude your research paper conclusion with a thought-provoking or memorable statement. This can leave a lasting impression on your readers and wrap up your paper effectively. Avoid introducing new information or arguments here.
  • Proofread and Revise : Carefully proofread your conclusion for grammar, spelling, and clarity. Ensure that your ideas flow smoothly and that your conclusion is coherent and well-structured.

Remember that a well-crafted research paper conclusion is a reflection of the strength of your research and your ability to communicate its significance effectively. It should leave a lasting impression on your readers and tie together all the threads of your paper. Now you know how to start the conclusion of a research paper and what elements to include to make it impactful, let’s look at a research paper conclusion sample.

conclusion and recommendation in research meaning

The research paper conclusion is a crucial part of your paper as it provides the final opportunity to leave a strong impression on your readers. In the research paper conclusion, summarize the main points of your research paper by restating your research statement, highlighting the most important findings, addressing the research questions or objectives, explaining the broader context of the study, discussing the significance of your findings, providing recommendations if applicable, and emphasizing the takeaway message. The main purpose of the conclusion is to remind the reader of the main point or argument of your paper and to provide a clear and concise summary of the key findings and their implications. All these elements should feature on your list of what to put in the conclusion of a research paper to create a strong final statement for your work.

A strong conclusion is a critical component of a research paper, as it provides an opportunity to wrap up your arguments, reiterate your main points, and leave a lasting impression on your readers. Here are the key elements of a strong research paper conclusion: 1. Conciseness : A research paper conclusion should be concise and to the point. It should not introduce new information or ideas that were not discussed in the body of the paper. 2. Summarization : The research paper conclusion should be comprehensive enough to give the reader a clear understanding of the research’s main contributions. 3 . Relevance : Ensure that the information included in the research paper conclusion is directly relevant to the research paper’s main topic and objectives; avoid unnecessary details. 4 . Connection to the Introduction : A well-structured research paper conclusion often revisits the key points made in the introduction and shows how the research has addressed the initial questions or objectives. 5. Emphasis : Highlight the significance and implications of your research. Why is your study important? What are the broader implications or applications of your findings? 6 . Call to Action : Include a call to action or a recommendation for future research or action based on your findings.

The length of a research paper conclusion can vary depending on several factors, including the overall length of the paper, the complexity of the research, and the specific journal requirements. While there is no strict rule for the length of a conclusion, but it’s generally advisable to keep it relatively short. A typical research paper conclusion might be around 5-10% of the paper’s total length. For example, if your paper is 10 pages long, the conclusion might be roughly half a page to one page in length.

In general, you do not need to include citations in the research paper conclusion. Citations are typically reserved for the body of the paper to support your arguments and provide evidence for your claims. However, there may be some exceptions to this rule: 1. If you are drawing a direct quote or paraphrasing a specific source in your research paper conclusion, you should include a citation to give proper credit to the original author. 2. If your conclusion refers to or discusses specific research, data, or sources that are crucial to the overall argument, citations can be included to reinforce your conclusion’s validity.

The conclusion of a research paper serves several important purposes: 1. Summarize the Key Points 2. Reinforce the Main Argument 3. Provide Closure 4. Offer Insights or Implications 5. Engage the Reader. 6. Reflect on Limitations

Remember that the primary purpose of the research paper conclusion is to leave a lasting impression on the reader, reinforcing the key points and providing closure to your research. It’s often the last part of the paper that the reader will see, so it should be strong and well-crafted.

  • Makar, G., Foltz, C., Lendner, M., & Vaccaro, A. R. (2018). How to write effective discussion and conclusion sections. Clinical spine surgery, 31(8), 345-346.
  • Bunton, D. (2005). The structure of PhD conclusion chapters.  Journal of English for academic purposes ,  4 (3), 207-224.

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Quick answers, conclusions and recommendations, related terms.

Writing the parts of scientific reports

22 Writing the conclusion & recommendations

There are probably some overlaps between the Conclusion and the Discussion section. Nevertheless, this section gives you the opportunity to highlight the most important points in your report, and is sometimes the only section read. Think about what your research/ study has achieved, and the most important findings and ideas you want the reader to know. As all studies have limitations also think about what you were not able to cover (this shows that you are able to evaluate your own work objectively).

Possible structure of this section:

conclusion and recommendation in research meaning

Use present perfect to sum up/ evaluate:

This study has explored/ has attempted …

Use past tense to state what your aim was and to refer to actions you carried out:

  • This study was intended to analyse …
  • The aim of this study was to …

Use present tense to evaluate your study and to state the generalizations and implications that you draw from your findings.

  • The results add to the knowledge of …
  • These findings s uggest that …

You can either use present tense or past tense to summarize your results.

  • The findings reveal …
  • It was found that …

Achievements of this study (positive)

  • This study provides evidence that …
  • This work has contributed to a number of key issues in the field such as …

Limitations of the study (negative)

  • Several limitations should be noted. First …

Combine positive and negative remarks to give a balanced assessment:

  • Although this research is somewhat limited in scope, its findings can provide a basis for future studies.
  • Despite the limitations, findings from the present study can help us understand …

Use more cautious language (modal verbs may, can, could)

  • There are a number of possible extensions of this research …
  • The findings suggest the possibility for future research on …
  • These results may be important for future studies on …
  • Examining a wider context could/ would lead …

Or indicate that future research is needed

  • There is still a need for future research to determine …
  • Further studies should be undertaken to discover…
  • It would be worthwhile to investigate …

conclusion and recommendation in research meaning

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Organizing Your Social Sciences Research Paper

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  • Purpose of Guide
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The conclusion is intended to help the reader understand why your research should matter to them after they have finished reading the paper. A conclusion is not merely a summary of the main topics covered or a re-statement of your research problem, but a synthesis of key points and, if applicable, where you recommend new areas for future research. For most college-level research papers, one or two well-developed paragraphs is sufficient for a conclusion, although in some cases, more paragraphs may be required in summarizing key findings and their significance.

Conclusions. The Writing Center. University of North Carolina; Conclusions. The Writing Lab and The OWL. Purdue University.

Importance of a Good Conclusion

A well-written conclusion provides you with important opportunities to demonstrate to the reader your understanding of the research problem. These include:

  • Presenting the last word on the issues you raised in your paper . Just as the introduction gives a first impression to your reader, the conclusion offers a chance to leave a lasting impression. Do this, for example, by highlighting key findings in your analysis that advance new understanding about the research problem, that are unusual or unexpected, or that have important implications applied to practice.
  • Summarizing your thoughts and conveying the larger significance of your study . The conclusion is an opportunity to succinctly re-emphasize  the "So What?" question by placing the study within the context of how your research advances past research about the topic.
  • Identifying how a gap in the literature has been addressed . The conclusion can be where you describe how a previously identified gap in the literature [described in your literature review section] has been filled by your research.
  • Demonstrating the importance of your ideas . Don't be shy. The conclusion offers you the opportunity to elaborate on the impact and significance of your findings. This is particularly important if your study approached examining the research problem from an unusual or innovative perspective.
  • Introducing possible new or expanded ways of thinking about the research problem . This does not refer to introducing new information [which should be avoided], but to offer new insight and creative approaches for framing or contextualizing the research problem based on the results of your study.

Bunton, David. “The Structure of PhD Conclusion Chapters.” Journal of English for Academic Purposes 4 (July 2005): 207–224; Conclusions. The Writing Center. University of North Carolina; Kretchmer, Paul. Twelve Steps to Writing an Effective Conclusion. San Francisco Edit, 2003-2008; Conclusions. The Writing Lab and The OWL. Purdue University; Assan, Joseph. "Writing the Conclusion Chapter: The Good, the Bad and the Missing." Liverpool: Development Studies Association (2009): 1-8.

Structure and Writing Style

I.  General Rules

The function of your paper's conclusion is to restate the main argument . It reminds the reader of the strengths of your main argument(s) and reiterates the most important evidence supporting those argument(s). Do this by stating clearly the context, background, and necessity of pursuing the research problem you investigated in relation to an issue, controversy, or a gap found in the literature. Make sure, however, that your conclusion is not simply a repetitive summary of the findings. This reduces the impact of the argument(s) you have developed in your essay.

When writing the conclusion to your paper, follow these general rules:

  • Present your conclusions in clear, simple language. Re-state the purpose of your study, then describe how your findings differ or support those of other studies and why [i.e., what were the unique or new contributions your study made to the overall research about your topic?].
  • Do not simply reiterate your findings or the discussion of your results. Provide a synthesis of arguments presented in the paper to show how these converge to address the research problem and the overall objectives of your study.
  • Indicate opportunities for future research if you haven't already done so in the discussion section of your paper. Highlighting the need for further research provides the reader with evidence that you have an in-depth awareness of the research problem and that further investigations should take place.

Consider the following points to help ensure your conclusion is presented well:

  • If the argument or purpose of your paper is complex, you may need to summarize the argument for your reader.
  • If, prior to your conclusion, you have not yet explained the significance of your findings or if you are proceeding inductively, use the end of your paper to describe your main points and explain their significance.
  • Move from a detailed to a general level of consideration that returns the topic to the context provided by the introduction or within a new context that emerges from the data. 

The conclusion also provides a place for you to persuasively and succinctly restate the research problem, given that the reader has now been presented with all the information about the topic . Depending on the discipline you are writing in, the concluding paragraph may contain your reflections on the evidence presented. However, the nature of being introspective about the research you have conducted will depend on the topic and whether your professor wants you to express your observations in this way.

NOTE : If asked to think introspectively about the topics, do not delve into idle speculation. Being introspective means looking within yourself as an author to try and understand an issue more deeply, not to guess at possible outcomes or make up scenarios not supported by the evidence.

II.  Developing a Compelling Conclusion

Although an effective conclusion needs to be clear and succinct, it does not need to be written passively or lack a compelling narrative. Strategies to help you move beyond merely summarizing the key points of your research paper may include any of the following strategies:

  • If your essay deals with a critical, contemporary problem, warn readers of the possible consequences of not attending to the problem proactively.
  • Recommend a specific course or courses of action that, if adopted, could address a specific problem in practice or in the development of new knowledge.
  • Cite a relevant quotation or expert opinion already noted in your paper in order to lend authority and support to the conclusion(s) you have reached [a good place to look is research from your literature review].
  • Explain the consequences of your research in a way that elicits action or demonstrates urgency in seeking change.
  • Restate a key statistic, fact, or visual image to emphasize the most important finding of your paper.
  • If your discipline encourages personal reflection, illustrate your concluding point by drawing from your own life experiences.
  • Return to an anecdote, an example, or a quotation that you presented in your introduction, but add further insight derived from the findings of your study; use your interpretation of results to recast it in new or important ways.
  • Provide a "take-home" message in the form of a succinct, declarative statement that you want the reader to remember about your study.

III. Problems to Avoid

Failure to be concise Your conclusion section should be concise and to the point. Conclusions that are too lengthy often have unnecessary information in them. The conclusion is not the place for details about your methodology or results. Although you should give a summary of what was learned from your research, this summary should be relatively brief, since the emphasis in the conclusion is on the implications, evaluations, insights, and other forms of analysis that you make. Strategies for writing concisely can be found here .

Failure to comment on larger, more significant issues In the introduction, your task was to move from the general [the field of study] to the specific [the research problem]. However, in the conclusion, your task is to move from a specific discussion [your research problem] back to a general discussion [i.e., how your research contributes new understanding or fills an important gap in the literature]. In short, the conclusion is where you should place your research within a larger context [visualize your paper as an hourglass--start with a broad introduction and review of the literature, move to the specific analysis and discussion, conclude with a broad summary of the study's implications and significance].

Failure to reveal problems and negative results Negative aspects of the research process should never be ignored. These are problems, deficiencies, or challenges encountered during your study should be summarized as a way of qualifying your overall conclusions. If you encountered negative or unintended results [i.e., findings that are validated outside the research context in which they were generated], you must report them in the results section and discuss their implications in the discussion section of your paper. In the conclusion, use your summary of the negative results as an opportunity to explain their possible significance and/or how they may form the basis for future research.

Failure to provide a clear summary of what was learned In order to be able to discuss how your research fits within your field of study [and possibly the world at large], you need to summarize briefly and succinctly how it contributes to new knowledge or a new understanding about the research problem. This element of your conclusion may be only a few sentences long.

Failure to match the objectives of your research Often research objectives in the social sciences change while the research is being carried out. This is not a problem unless you forget to go back and refine the original objectives in your introduction. As these changes emerge they must be documented so that they accurately reflect what you were trying to accomplish in your research [not what you thought you might accomplish when you began].

Resist the urge to apologize If you've immersed yourself in studying the research problem, you presumably should know a good deal about it [perhaps even more than your professor!]. Nevertheless, by the time you have finished writing, you may be having some doubts about what you have produced. Repress those doubts! Don't undermine your authority by saying something like, "This is just one approach to examining this problem; there may be other, much better approaches that...." The overall tone of your conclusion should convey confidence to the reader.

Assan, Joseph. "Writing the Conclusion Chapter: The Good, the Bad and the Missing." Liverpool: Development Studies Association (2009): 1-8; Concluding Paragraphs. College Writing Center at Meramec. St. Louis Community College; Conclusions. The Writing Center. University of North Carolina; Conclusions. The Writing Lab and The OWL. Purdue University; Freedman, Leora  and Jerry Plotnick. Introductions and Conclusions. The Lab Report. University College Writing Centre. University of Toronto; Leibensperger, Summer. Draft Your Conclusion. Academic Center, the University of Houston-Victoria, 2003; Make Your Last Words Count. The Writer’s Handbook. Writing Center. University of Wisconsin Madison; Miquel, Fuster-Marquez and Carmen Gregori-Signes. “Chapter Six: ‘Last but Not Least:’ Writing the Conclusion of Your Paper.” In Writing an Applied Linguistics Thesis or Dissertation: A Guide to Presenting Empirical Research . John Bitchener, editor. (Basingstoke,UK: Palgrave Macmillan, 2010), pp. 93-105; Tips for Writing a Good Conclusion. Writing@CSU. Colorado State University; Kretchmer, Paul. Twelve Steps to Writing an Effective Conclusion. San Francisco Edit, 2003-2008; Writing Conclusions. Writing Tutorial Services, Center for Innovative Teaching and Learning. Indiana University; Writing: Considering Structure and Organization. Institute for Writing Rhetoric. Dartmouth College.

Writing Tip

Don't Belabor the Obvious!

Avoid phrases like "in conclusion...," "in summary...," or "in closing...." These phrases can be useful, even welcome, in oral presentations. But readers can see by the tell-tale section heading and number of pages remaining to read, when an essay is about to end. You'll irritate your readers if you belabor the obvious.

Assan, Joseph. "Writing the Conclusion Chapter: The Good, the Bad and the Missing." Liverpool: Development Studies Association (2009): 1-8.

Another Writing Tip

New Insight, Not New Information!

Don't surprise the reader with new information in your conclusion that was never referenced anywhere else in the paper and, as such, the conclusion rarely has citations to sources. If you have new information to present, add it to the discussion or other appropriate section of the paper. Note that, although no actual new information is introduced, the conclusion, along with the discussion section, is where you offer your most "original" contributions in the paper; the conclusion is where you describe the value of your research, demonstrate that you understand the material that you’ve presented, and locate your findings within the larger context of scholarship on the topic, including describing how your research contributes new insights or valuable insight to that scholarship.

Assan, Joseph. "Writing the Conclusion Chapter: The Good, the Bad and the Missing." Liverpool: Development Studies Association (2009): 1-8; Conclusions. The Writing Center. University of North Carolina.

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Organizing Academic Research Papers: 9. The Conclusion

  • Purpose of Guide
  • Design Flaws to Avoid
  • Glossary of Research Terms
  • Narrowing a Topic Idea
  • Broadening a Topic Idea
  • Extending the Timeliness of a Topic Idea
  • Academic Writing Style
  • Choosing a Title
  • Making an Outline
  • Paragraph Development
  • Executive Summary
  • Background Information
  • The Research Problem/Question
  • Theoretical Framework
  • Citation Tracking
  • Content Alert Services
  • Evaluating Sources
  • Primary Sources
  • Secondary Sources
  • Tertiary Sources
  • What Is Scholarly vs. Popular?
  • Qualitative Methods
  • Quantitative Methods
  • Using Non-Textual Elements
  • Limitations of the Study
  • Common Grammar Mistakes
  • Avoiding Plagiarism
  • Footnotes or Endnotes?
  • Further Readings
  • Annotated Bibliography
  • Dealing with Nervousness
  • Using Visual Aids
  • Grading Someone Else's Paper
  • How to Manage Group Projects
  • Multiple Book Review Essay
  • Reviewing Collected Essays
  • About Informed Consent
  • Writing Field Notes
  • Writing a Policy Memo
  • Writing a Research Proposal
  • Acknowledgements

The conclusion is intended to help the reader understand why your research should matter to them after they have finished reading the paper. A conclusion is not merely a summary of your points or a re-statement of your research problem but a synthesis of key points. For most essays, one well-developed paragraph is sufficient for a conclusion, although in some cases, a two-or-three paragraph conclusion may be required.

Importance of a Good Conclusion

A well-written conclusion provides you with several important opportunities to demonstrate your overall understanding of the research problem to the reader. These include:

  • Presenting the last word on the issues you raised in your paper . Just as the introduction gives a first impression to your reader, the conclusion offers a chance to leave a lasting impression. Do this, for example, by highlighting key points in your analysis or findings.
  • Summarizing your thoughts and conveying the larger implications of your study . The conclusion is an opportunity to succinctly answer the "so what?" question by placing the study within the context of past research about the topic you've investigated.
  • Demonstrating the importance of your ideas . Don't be shy. The conclusion offers you a chance to elaborate on the significance of your findings.
  • Introducing possible new or expanded ways of thinking about the research problem . This does not refer to introducing new information [which should be avoided], but to offer new insight and creative approaches for framing/contextualizing the research problem based on the results of your study.

Conclusions . The Writing Center. University of North Carolina; Kretchmer, Paul. Twelve Steps to Writing an Effective Conclusion . San Francisco Edit, 2003-2008.

Structure and Writing Style

https://writing.wisc.edu/wp-content/uploads/sites/535/2018/07/conclusions_uwmadison_writingcenter_aug2012.pdf I.  General Rules

When writing the conclusion to your paper, follow these general rules:

  • State your conclusions in clear, simple language.
  • Do not simply reiterate your results or the discussion.
  • Indicate opportunities for future research, as long as you haven't already done so in the discussion section of your paper.

The function of your paper's conclusion is to restate the main argument . It reminds the reader of the strengths of your main argument(s) and reiterates the most important evidence supporting those argument(s). Make sure, however, that your conclusion is not simply a repetitive summary of the findings because this reduces the impact of the argument(s) you have developed in your essay.

Consider the following points to help ensure your conclusion is appropriate:

  • If the argument or point of your paper is complex, you may need to summarize the argument for your reader.
  • If, prior to your conclusion, you have not yet explained the significance of your findings or if you are proceeding inductively, use the end of your paper to describe your main points and explain their significance.
  • Move from a detailed to a general level of consideration that returns the topic to the context provided by the introduction or within a new context that emerges from the data.

The conclusion also provides a place for you to persuasively and succinctly restate your research problem, given that the reader has now been presented with all the information about the topic . Depending on the discipline you are writing in, the concluding paragraph may contain your reflections on the evidence presented, or on the essay's central research problem. However, the nature of being introspective about the research you have done will depend on the topic and whether your professor wants you to express your observations in this way.

NOTE : Don't delve into idle speculation. Being introspective means looking within yourself as an author to try and understand an issue more deeply not to guess at possible outcomes.

II.  Developing a Compelling Conclusion

Strategies to help you move beyond merely summarizing the key points of your research paper may include any of the following.

  • If your essay deals with a contemporary problem, warn readers of the possible consequences of not attending to the problem.
  • Recommend a specific course or courses of action.
  • Cite a relevant quotation or expert opinion to lend authority to the conclusion you have reached [a good place to look is research from your literature review].
  • Restate a key statistic, fact, or visual image to drive home the ultimate point of your paper.
  • If your discipline encourages personal reflection, illustrate your concluding point with a relevant narrative drawn from your own life experiences.
  • Return to an anecdote, an example, or a quotation that you introduced in your introduction, but add further insight that is derived from the findings of your study; use your interpretation of results to reframe it in new ways.
  • Provide a "take-home" message in the form of a strong, succient statement that you want the reader to remember about your study.

III. Problems to Avoid Failure to be concise The conclusion section should be concise and to the point. Conclusions that are too long often have unnecessary detail. The conclusion section is not the place for details about your methodology or results. Although you should give a summary of what was learned from your research, this summary should be relatively brief, since the emphasis in the conclusion is on the implications, evaluations, insights, etc. that you make. Failure to comment on larger, more significant issues In the introduction, your task was to move from general [the field of study] to specific [your research problem]. However, in the conclusion, your task is to move from specific [your research problem] back to general [your field, i.e., how your research contributes new understanding or fills an important gap in the literature]. In other words, the conclusion is where you place your research within a larger context. Failure to reveal problems and negative results Negative aspects of the research process should never be ignored. Problems, drawbacks, and challenges encountered during your study should be included as a way of qualifying your overall conclusions. If you encountered negative results [findings that are validated outside the research context in which they were generated], you must report them in the results section of your paper. In the conclusion, use the negative results as an opportunity to explain how they provide information on which future research can be based. Failure to provide a clear summary of what was learned In order to be able to discuss how your research fits back into your field of study [and possibly the world at large], you need to summarize it briefly and directly. Often this element of your conclusion is only a few sentences long. Failure to match the objectives of your research Often research objectives change while the research is being carried out. This is not a problem unless you forget to go back and refine your original objectives in your introduction, as these changes emerge they must be documented so that they accurately reflect what you were trying to accomplish in your research [not what you thought you might accomplish when you began].

Resist the urge to apologize If you've immersed yourself in studying the research problem, you now know a good deal about it, perhaps even more than your professor! Nevertheless, by the time you have finished writing, you may be having some doubts about what you have produced. Repress those doubts!  Don't undermine your authority by saying something like, "This is just one approach to examining this problem; there may be other, much better approaches...."

Concluding Paragraphs. College Writing Center at Meramec. St. Louis Community College; Conclusions . The Writing Center. University of North Carolina; Conclusions . The Writing Lab and The OWL. Purdue University; Freedman, Leora  and Jerry Plotnick. Introductions and Conclusions . The Lab Report. University College Writing Centre. University of Toronto; Leibensperger, Summer. Draft Your Conclusion. Academic Center, the University of Houston-Victoria, 2003; Make Your Last Words Count . The Writer’s Handbook. Writing Center. University of Wisconsin, Madison; Tips for Writing a Good Conclusion . Writing@CSU. Colorado State University; Kretchmer, Paul. Twelve Steps to Writing an Effective Conclusion . San Francisco Edit, 2003-2008; Writing Conclusions . Writing Tutorial Services, Center for Innovative Teaching and Learning. Indiana University; Writing: Considering Structure and Organization . Institute for Writing Rhetoric. Dartmouth College.

Writing Tip

Don't Belabor the Obvious!

Avoid phrases like "in conclusion...," "in summary...," or "in closing...." These phrases can be useful, even welcome, in oral presentations. But readers can see by the tell-tale section heading and number of pages remaining to read, when an essay is about to end. You'll irritate your readers if you belabor the obvious.

Another Writing Tip

New Insight, Not New Information!

Don't surprise the reader with new information in your Conclusion that was never referenced anywhere else in the paper. If you have new information to present, add it to the Discussion or other appropriate section of the paper.  Note that, although no actual new information is introduced, the conclusion is where you offer your most "original" contributions in the paper; it's where you describe the value of your research, demonstrate your understanding of the material that you’ve presented, and locate your findings within the larger context of scholarship on the topic.

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  • How to Write Recommendations in Research | Examples & Tips

How to Write Recommendations in Research | Examples & Tips

Published on 15 September 2022 by Tegan George .

Recommendations in research are a crucial component of your discussion section and the conclusion of your thesis , dissertation , or research paper .

As you conduct your research and analyse the data you collected , perhaps there are ideas or results that don’t quite fit the scope of your research topic . Or, maybe your results suggest that there are further implications of your results or the causal relationships between previously-studied variables than covered in extant research.

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Table of contents

What should recommendations look like, building your research recommendation, how should your recommendations be written, recommendation in research example, frequently asked questions about recommendations.

Recommendations for future research should be:

  • Concrete and specific
  • Supported with a clear rationale
  • Directly connected to your research

Overall, strive to highlight ways other researchers can reproduce or replicate your results to draw further conclusions, and suggest different directions that future research can take, if applicable.

Relatedly, when making these recommendations, avoid:

  • Undermining your own work, but rather offer suggestions on how future studies can build upon it
  • Suggesting recommendations actually needed to complete your argument, but rather ensure that your research stands alone on its own merits
  • Using recommendations as a place for self-criticism, but rather as a natural extension point for your work

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There are many different ways to frame recommendations, but the easiest is perhaps to follow the formula of research question   conclusion  recommendation. Here’s an example.

Conclusion An important condition for controlling many social skills is mastering language. If children have a better command of language, they can express themselves better and are better able to understand their peers. Opportunities to practice social skills are thus dependent on the development of language skills.

As a rule of thumb, try to limit yourself to only the most relevant future recommendations: ones that stem directly from your work. While you can have multiple recommendations for each research conclusion, it is also acceptable to have one recommendation that is connected to more than one conclusion.

These recommendations should be targeted at your audience, specifically toward peers or colleagues in your field that work on similar topics to yours. They can flow directly from any limitations you found while conducting your work, offering concrete and actionable possibilities for how future research can build on anything that your own work was unable to address at the time of your writing.

See below for a full research recommendation example that you can use as a template to write your own.

The current study can be interpreted as a first step in the research on COPD speech characteristics. However, the results of this study should be treated with caution due to the small sample size and the lack of details regarding the participants’ characteristics.

Future research could further examine the differences in speech characteristics between exacerbated COPD patients, stable COPD patients, and healthy controls. It could also contribute to a deeper understanding of the acoustic measurements suitable for e-health measurements.

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While it may be tempting to present new arguments or evidence in your thesis or disseration conclusion , especially if you have a particularly striking argument you’d like to finish your analysis with, you shouldn’t. Theses and dissertations follow a more formal structure than this.

All your findings and arguments should be presented in the body of the text (more specifically in the discussion section and results section .) The conclusion is meant to summarize and reflect on the evidence and arguments you have already presented, not introduce new ones.

The conclusion of your thesis or dissertation should include the following:

  • A restatement of your research question
  • A summary of your key arguments and/or results
  • A short discussion of the implications of your research

For a stronger dissertation conclusion , avoid including:

  • Generic concluding phrases (e.g. “In conclusion…”)
  • Weak statements that undermine your argument (e.g. “There are good points on both sides of this issue.”)

Your conclusion should leave the reader with a strong, decisive impression of your work.

In a thesis or dissertation, the discussion is an in-depth exploration of the results, going into detail about the meaning of your findings and citing relevant sources to put them in context.

The conclusion is more shorter and more general: it concisely answers your main research question and makes recommendations based on your overall findings.

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How to Write Summary, Conclusion and Recommendations in a Research

How to Write Summary, Conclusion and Recommendations in a Research

The summary, conclusion and recommendations are the last part of the research work . It is essential to have this in all research work, both qualitative and quantitative . When perusing a research work (thesis or research articles ), the readers go directly to the summary, conclusion, and recommendation and see if they could point out what the dissertation is saying because it is common in this chapter.

The gap in the literature identified in the introduction signifies what the scholars decided to look at, what they finally assert when their study is done. What did it inform them, and what they are teaching us about the matter. Did they get the expected outcomes? If so, why or why not? The thesis is likely to be a very logical and provisional assertion instead of a broad statement.

Almost every research study concludes by encouraging other academics to continue the work by stating that more investigation is necessary on the topic. Nevertheless, please do not confuse this ruling with the thesis; it is merely a tradition. Frequently, the researchers offer detailed information about possible future research that might or can be undertaken in an attempt to make sense of the findings of their research. The following steps will guide in write a good chapter five:

Step 1: Summary

It is now time to go through each section and highlight the critical statements. What information does the reader have to fully comprehend the article’s central argument or inference? Remember that a summary does not necessitate rephrasing every single line of the article. The idea is to identify the main elements while excluding any background knowledge or optional information. A summary of findings reveals and summarises the most critical factors and outcomes of a study, including the best theoretical boundaries and the finality of the substantiation for each result. It tells the reader what has been done, how it has been done, and the study results. An engaging summary of findings allows the readers to see as many or more minor findings and just about relevant data about each result, see effect estimates presented in various ways, and view clarifications of the evidence supplied.

Step 2: Conclusions

After analysing the literature, the conclusion should aid in understanding why the study is essential to them. A conclusion is a synthesis of critical elements, not just a description of the points or a re-statement of the problem statement. For most research studies, one well-developed paragraph suffices as a conclusion. However, a two- or three paragraph conclusion may be considered necessary in some situations. It is vital to include a conclusion in a thesis, journal article or dissertation to inform the readers of the strength and effect of the assertions in the study. Concluding statements in a thesis can also aid in refocusing the reader’s attention on the quality statements and verifiable details of the research. Conclusions can also form a foundation for further research, generate new ideas to address an issue raised in the thesis or propose novel approaches to a problem. Consider the steps below to help you get started when writing the conclusion of your study:

  • Restate the research topic.
  • Reiterate the thesis (objective of the study).
  • Make a summary of the main points.
  • Mention the relevance or outcomes.
  • Wrap up your thoughts.

Avoidable Issues

  • Inability to be concise.
  • Inability to make a statement on more significant, more important issues.
  • Failure to expose problems leads to adverse outcomes.
  • Inability to provide a brief overview of what was observed.
  • Failure to align the research aim and objectives.
  • Refrain from apologizing.

Step 3: Recommendations

You may have already created suggestions for future studies in the discussion, but the recommendation is a great place to explain, taking into account the potential ramifications of your research results for practice and theory. The recommendations should be premised on the conclusions of the study.

Specific instances

  • Predicated on these conclusions, managers should consider… Additional researches could address…
  • Further research is necessary to confirm the causative factors of/effects of/relationship between…

Avoid overstating the practicability of the study. If you’re making policy, business, or other policy implications, it’s best to structure them as suggestions instead of instructions. Academic research aims to educate, demonstrate, and explore rather than to instruct.

Make sure not to undermine the research carried out when making recommendations for additional research. Academic research aims to educate, demonstrate, and explore rather than to instruct.

Make sure not to undermine the research carried out when making recommendations for additional research.

Step 4: Recommendations for further study

Future studies may confirm, build on, or supplement your findings, but they should not be considered necessary to accomplish them. Highlight the contributions. Make sure the reader understands how the study has contributed to knowledge in the field in focus.

The suggestions for further study should address other areas that your study did not cover. That is, suggestions for further study should expand on the limitations and scope of your study.

//

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Unearthing the Real Process Behind the Event Data pp 227–237 Cite as

Conclusions and Recommendations for Future Research

  • Gert Janssenswillen   ORCID: orcid.org/0000-0002-7474-2088 7  
  • First Online: 08 April 2021

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At the start of this thesis, we set out on a quest for process realism: viewing and representing processes as they really are, as distinguished from the speculative.

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Conducting Biosocial Surveys: Collecting, Storing, Accessing, and Protecting Biospecimens and Biodata (2010)

Chapter: 5 findings, conclusions, and recommendations, 5 findings, conclusions, and recommendations.

A s the preceding chapters have made clear, incorporating biological specimens into social science surveys holds great scientific potential, but also adds a variety of complications to the tasks of both individual researchers and institutions. These complications arise in a number of areas, including collecting, storing, using, and distributing biospecimens; sharing data while protecting privacy; obtaining informed consent from participants; and engaging with Institutional Review Boards (IRBs). Any effort to make such research easier and more effective will need to address the issues in these areas.

In considering its recommendations, the panel found it useful to think of two categories: (1) recommendations that apply to individual investigators, and (2) recommendations that are addressed to the National Institute on Aging (NIA) or other institutions, particularly funding agencies. Researchers who wish to collect biological specimens with social science data will need to develop new skills in a variety of areas, such as the logistics of specimen storage and management, the development of more diverse informed consent forms, and ways of dealing with the disclosure risks associated with sharing biogenetic data. At the same time, NIA and other funding agencies must provide researchers the tools they need to succeed. These tools include such things as biorepositories for maintaining and distributing specimens, better guidance on informed consent policies, and better ways to share data without risking confidentiality.

TAKING ADVANTAGE OF EXISTING EXPERTISE

Although working with biological specimens will be new and unfamiliar to many social scientists, it is an area in which biomedical researchers have a great deal of expertise and experience. Many existing documents describe recommended procedures and laboratory practices for the handling of biospecimens. These documents provide an excellent starting point for any social scientist who is interested in adding biospecimens to survey research.

Recommendation 1: Social scientists who are planning to add biological specimens to their survey research should familiarize themselves with existing best practices for the collection, storage, use, and distribution of biospecimens. First and foremost, the design of the protocol for collec tion must ensure the safety of both participants and survey staff (data and specimen collectors and handlers).

Although existing best-practice documents were not developed with social science surveys in mind, their guidelines have been field-tested and approved by numerous IRBs and ethical oversight committees. The most useful best-practice documents are updated frequently to reflect growing knowledge and changing opinions about the best ways to collect, store, use, and distribute biological specimens. At the same time, however, many issues arising from the inclusion of biospecimens in social science surveys are not fully addressed in the best-practice documents intended for biomedical researchers. For guidance on these issues, it will be necessary to seek out information aimed more specifically at researchers at the intersection of social science and biomedicine.

COLLECTING, STORING, USING, AND DISTRIBUTING BIOSPECIMENS

As described in Chapter 2 , the collection, storage, use, and distribution of biospecimens and biodata are tasks that are likely to be unfamiliar to many social scientists and that raise a number of issues with which even specialists are still grappling. For example, which biospecimens in a repository should be shared, given that in most cases the amount of each specimen is limited? And given that the available technology for cost-efficient analysis of biospecimens, particularly genetic analysis, is rapidly improving, how much of any specimen should be used for immediate research and analysis, and how much should be stored for analysis at a later date? Collecting, storing, using, and distributing biological specimens also present significant practical and financial challenges for social scientists. Many of the questions they must address, such as exactly what should be held, where it should be held, and what should be shared or distributed, have not yet been resolved.

Developing Data Sharing Plans

An important decision concerns who has access to any leftover biospecimens. This is a problem more for biospecimens than for biodata because in most cases, biospecimens can be exhausted. Should access be determined according to the principle of first funded, first served? Should there be a formal application process for reviewing the scientific merits of a particular investigation? For studies that involve international collaboration, should foreign investigators have access? And how exactly should these decisions be made? Recognizing that some proposed analyses may lie beyond the competence of the original investigators, as well as the possibility that principal investigators may have a conflict of interest in deciding how to use any remaining biospecimens, one option is for a principal investigator to assemble a small scientific committee to judge the merits of each application, including the relevance of the proposed study to the parent study and the capacities of the investigators. Such committees should publish their review criteria to help prospective applicants. A potential problem with such an approach, however, is that many projects may not have adequate funding to carry out such tasks.

Recommendation 2: Early in the planning process, principal investigators who will be collecting biospecimens as part of a social science survey should develop a complete data sharing plan.

This plan should spell out the criteria for allowing other researchers to use (and therefore deplete) the available stock of biospecimens, as well as to gain access to any data derived therefrom. To avoid any appearance of self-interest, a project might empower an external advisory board to make decisions about access to its data. The data sharing plan should also include provisions for the storage and retrieval of biospecimens and clarify how the succession of responsibility for and control of the biospecimens will be handled at the conclusion of the project.

Recommendation 3: NIA (or preferably the National Institutes of Health [NIH]) should publish guidelines for principal investigators containing a list of points that need to be considered for an acceptable data sharing plan. In addition to staff review, Scientific Review Panels should read and comment on all proposed data sharing plans. In much the same way as an unacceptable human subjects plan, an inadequate data sharing plan should hold up an otherwise acceptable proposal.

Supporting Social Scientists in the Storage of Biospecimens

The panel believes that many social scientists who decide to add the collection of biospecimens to their surveys may be ill equipped to provide for the storage and distribution of the specimens.

Conclusion: The issues related to the storage and distribution of biospecimens are too complex and involve too many hidden costs to assume that social scientists without suitable knowledge, experience, and resources can handle them without assistance.

Investigators should therefore have the option of delegating the storage and distribution of biospecimens collected as part of social science surveys to a centralized biorepository. Depending on the circumstances, a project might choose to utilize such a facility for immediate use, long-term or archival storage, or not at all.

Recommendation 4: NIA and other relevant funding agencies should support at least one central facility for the storage and distribution of biospecimens collected as part of the research they support.

PROTECTING PRIVACY AND CONFIDENTIALITY: SHARING DIGITAL REPRESENTATIONS OF BIOLOGICAL AND SOCIAL DATA

Several different types of data must be kept confidential: survey data, data derived from biospecimens, and all administrative and operational data. In the discussion of protecting confidentiality and privacy, this report has focused on biodata, but the panel believes it is important to protect all the data collected from survey participants. For many participants, for example, data on wealth, earnings, or sexual behavior can be as or more sensitive than genetic data.

Conclusion: Although biodata tend to receive more attention in discussions of privacy and confidentiality, social science and operational data can be sensitive in their own right and deserve similar attention in such discussions.

Protecting the participants in a social science survey that collects biospecimens requires securing the data, but data are most valuable when they are made available to researchers as widely as possible. Thus there is an inherent tension between the desire to protect the privacy of the participants and the desire to derive as much scientific value from the data as possible, particularly since the costs of data collection and analysis are so high. The following recommendations regarding confidentiality are made in the spirit of balancing these equally important needs.

Genomic data present a particular challenge. Several researchers have demonstrated that it is possible to identify individuals with even modest amounts of such data. When combined with social science data, genomic data may pose an even greater risk to confidentiality. It is difficult to know how much or which genomic data, when combined with social science data, could become critical identifiers in the future. Although the problem is most significant with genomic data, similar challenges can arise with other kinds of data derived from biospecimens.

Conclusion: Unrestricted distribution of genetic and other biodata risks violating promises of confidentiality made to research participants.

There are two basic approaches to protecting confidentiality: restricting data and restricting access. Restricting data—for example, by stripping individual and spatial identifiers and modifying the data to make it difficult or impossible to trace them back to their source—usually makes it possible to release social science data widely. In the case of biodata, however, there is no answer to how little data is required to make a participant uniquely identifiable. Consequently, any release of biodata must be carefully managed to protect confidentiality.

Recommendation 5: No individual-level data containing uniquely identify ing variables, such as genomic data, should be publicly released without explicit informed consent.

Recommendation 6: Genomic data and other individual-level data con taining uniquely identifying variables that are stored or in active use by investigators on their institutional or personal computers should be encrypted at all times.

Even if specific identifying variables, such as names and addresses, are stripped from data, it is still often possible to identify the individuals associated with the data by other means, such as using the variables that remain (age, sex, marital status, family income, etc.) to zero in on possible candidates. In the case of biodata that do not uniquely identify individuals and can change with time, such as blood pressure and physical measurements, it may be possible to share the data with no more protection than stripping identifying variables. Even these data, however, if known to intruders, can increase identification disclosure risk when combined with enough other data. With sufficient characteristics to match, intruders can uniquely identify individuals in shared data if given access to another data source that contains the same information plus identifiers.

Conclusion: Even nonunique biodata, if combined with social science data, may pose a serious risk of reidentification.

In the case of high-dimensional genomic data, standard disclosure limitation techniques, such as data perturbation, are not effective with respect to preserving the utility of the data because they involve such extreme alterations that they would severely distort analyses aimed at determining gene–gene and gene–environment interactions. Standard disclosure limitation methods could be used to generate public-use data sets that would enable low-dimensional analyses involving genes, for example, one gene at a time. However, with several such public releases, it may be possible for a key match to be used to construct a data set with higher-dimensional genomic data.

Conclusion: At present, no data restriction strategy has been demonstrated to protect confidentiality while preserving the usefulness of the data for drawing inferences involving high-dimensional interactions among genomic and social science variables, which are increasingly the target of research. Providing public-use genomic data requires such intense data masking to protect confidentiality that it would distort the high-dimensional analyses that could result in ground-breaking research progress.

Recommendation 7: Both rich genomic data acquired for research and sensitive and potentially identifiable social science data that do not change (or change very little) with time should be shared only under restricted circumstances, such as licensing and (actual or virtual) data enclaves.

As discussed in Chapter 3 , the four basic ways to restrict access to data are licensing, remote execution centers, data enclaves, and virtual data enclaves. Each has its advantages and disadvantages. 1 Licensing, for example, is the least restrictive for a researcher in terms of access to the data, but the licensing process itself can be lengthy and burdensome. Thus it would be useful if the licensing process could be facilitated.

Recommendation 8: NIA (or preferably NIH) should develop new stan dards and procedures for licensing confidential data in ways that will maximize timely access while maintaining security and that can be used by data repositories and by projects that distribute data.

Ways to improve the other approaches to restricted access are needed as well. For example, improving the convenience and availability of virtual data enclaves could increase the use of combined social science and biodata without

a significant increase in risk to confidentiality. The panel notes that much of the discussion of the confidentiality risk posed by the various approaches is theoretical; no one has a clear idea of just what disclosure risks are associated with the various ways of sharing data. It is important to learn more about these disclosure risks for a variety of reasons—determining how to minimize the risks, for instance, or knowing which approaches to sharing data pose the least risk. It would also be useful to be able to describe disclosure risks more accurately to survey participants.

Recommendation 9: NIA and other funding agencies should assess the strength of confidentiality protections through periodic expert audits of confidentiality and computer security. Willingness to participate in such audits should be a condition for receipt of NIA support. Beyond enforce ment, the purpose of such audits would be to identify challenges and solutions.

Evaluating risks and applying protection methods, whether they involve restricted access or restricted data, is a complex process requiring expertise in disclosure protection methods that exceeds what individual principal investigators and their institutions usually possess. Currently, not enough is known to be able to represent these risks either fully or accurately. The NIH requirement for data sharing necessitates a large investment of resources to anticipate which variables are potentially available to intruders and to alter data in ways that reduce disclosure risks while maintaining the utility of the data. Such resources are better spent by principal investigators on collecting and analyzing the data.

Recommendation 10: NIH should consider funding Centers of Excellence to explore new ways of protecting digital representations of data and to assist principal investigators wishing to share data with others. NIH should also support research on disclosure risks and limitations.

Principal investigators could send digital data to these centers, which would organize and manage any restricted access or restricted data policies or provide advisory services to investigators. NIH would maintain the authority to penalize those who violated any confidentiality agreements, for example, by denying them or their home institution NIH funding. Models for these centers include the Inter-university Consortium for Political and Social Research (ICPSR) and its projects supported by NIH and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the UK data sharing archive. The centers would alleviate the burden of data sharing as mandated of principal investigators by NIH and place it in expert hands. However, excellence in the design of data access and control systems

is likely to require intimate knowledge of each specific data resource, so data producers should be involved in the systems’ development.

INFORMED CONSENT

As described in Chapter 4 , informed consent is a complex subject involving many issues that are still being debated; the growing power of genetic analysis techniques and bioinformatics has only added to this complexity. Given the rapid pace of advances in scientific knowledge and in the technology used to analyze biological materials, it is impossible to predict what information might be gleaned from biological specimens just a few years hence; accordingly, it is impossible, even in theory, to talk about perfectly informed consent. The best one can hope for is relatively well-informed consent from a study’s participants, but knowing precisely what that means is difficult. Determining the scope of informed consent adds another layer of complexity. Will new analyses be covered under the existing consent, for example? There are no clear guidelines on such questions, yet specific details on the scope of consent will likely affect an IRB’s reaction to a study proposal.

What Individual Researchers Need to Know and Do Regarding Informed Consent

To be sure, there is a wide range of views about the practicality of providing adequate protection to participants while proceeding with the scientific enterprise, from assertions that it is simply not possible to provide adequate protection to offers of numerous procedural safeguards but no iron-clad guarantees. This report takes the latter position—that investigators should do their best to communicate adequately and accurately with participants, to provide procedural safeguards to the extent possible, and not to promise what is not possible. 2 Social science researchers need to know that adding the collection of biospecimens to social science surveys changes the nature of informed consent. Informed consent for a traditional social science survey may entail little more than reading a short script over the phone and asking whether the participant is willing to continue; obtaining informed consent for the collection and use of biospecimens and biodata is generally a much more involved process.

Conclusion: Social scientists should be made aware that the process of obtaining informed consent for the use of biospecimens and biodata typically differs from social science norms.

If participants are to provide truly informed consent to taking part in any study, they must be given a certain minimum amount of information. They should be told, for example, what the purpose of the study is, how it is to be carried out, and what participants’ roles are. In addition, because of the unique risks associated with providing biospecimens, participants in a social science survey that involves the collection of such specimens should be provided with other types of information as well. In particular, they should be given detail on the storage and use of the specimens that relates to those risks and can assist them in determining whether to take part in the study.

Recommendation 11: In designing a consent form for the collection of biospecimens, in addition to those elements that are common to social science and biomedical research, investigators should ensure that certain other information is provided to participants:

how long researchers intend to retain their biospecimens and the genomic and other biodata that may be derived from them;

both the risks associated with genomic data and the limits of what they can reveal;

which other researchers will have access to their specimens, to the data derived therefrom, and to information collected in a survey questionnaire;

the limits on researchers’ ability to maintain confidentiality;

any potential limits on participants’ ability to withdraw their speci mens or data from the research;

the penalties 3 that may be imposed on researchers for various types of breaches of confidentiality; and

what plans have been put in place to return to them any medically relevant findings.

Researchers who fail to properly plan for and handle all of these issues before proceeding with a study are in essence compromising assurances under informed consent. The literature on informed consent emphasizes the importance of ensuring that participants understand reasonably well what they are consenting to. This understanding cannot be taken for granted, particularly as it pertains to the use of biological specimens and the data derived therefrom.

While it is not possible to guarantee that participants have a complete understanding of the scientific uses of their specimens or all the possible risks of their participation, they should be able to make a relatively well-informed decision about whether to take part in the study. Thus the ability of various participants to understand the research and the informed consent process must be considered. Even impaired individuals may be able to participate in research if their interests are protected and they can do so only through proxy consent. 4

Recommendation 12: NIA should locate and publicize positive examples of the documentation of consent processes for the collection of biospeci mens. In particular, these examples should take into account the special needs of certain individuals, such as those with sensory problems and the cognitively impaired.

Participants in a biosocial survey are likely to have different levels of comfort concerning how their biospecimens and data will be used. Some may be willing to provide only answers to questions, for example, while others may both answer questions and provide specimens. Among those who provide specimens, some may be willing for the specimens to be used only for the current study, while others may consent to their use in future studies. One effective way to deal with these different comfort levels is to offer a tiered approach to consent that allows participants to determine just how their specimens and data will be used. Tiers might include participating in the survey, providing specimens for genetic and/or nongenetic analysis in a particular study, and allowing the specimens and data to be stored for future uses (genetic and/or nongenetic). For those participants who are willing to have their specimens and data used in future studies, researchers should tell them what sort of approval will be obtained for such use. For example, an IRB may demand reconsent, in which case participants may have to be contacted again before their specimens and data can be used. Ideally, researchers should design their consent forms to avoid the possibility that an IRB will demand a costly or infeasible reconsent process.

Recommendation 13: Researchers should consider adopting a tiered approach to obtaining consent. Participants who are willing to have their specimens and data used in future studies should be informed about the process that will be used to obtain approval for such uses.

What Institutions Should Do Regarding Informed Consent

Because the details of informed consent vary from study to study, individual investigators must bear ultimate responsibility for determining the details of informed consent for any particular study. Thus researchers must understand the various issues and concerns surrounding informed consent and be prepared to make decisions about the appropriate approach for their research in consultation with staff of survey organizations. These decisions should be addressed in the training of survey interviewers. As noted above, however, the issues surrounding informed consent are complex and not completely resolved, and researchers have few options for learning about informed consent as it applies to social science studies that collect biospecimens. Thus it makes sense for agencies funding this research, the Office for Human Research Protection (OHRP), or other appropriate organizations (for example, Public Responsibility in Medicine and Research [PRIM&R]) to provide opportunities for such learning, taking into account the fact that the issues arising in biosocial research do not arise in the standard informed consent situations encountered in social science research. It should also be made clear that the researchers’ institution is usually deemed (e.g., in the courts) to bear much of the responsibility for informed consent.

Recommendation 14: NIA, OHRP, and other appropriate organizations should sponsor training programs, create training modules, and hold informational workshops on informed consent for investigators, staff of survey organizations, including field staff, administrators, and mem bers of IRBs who oversee surveys that collect social science data and biospecimens.

The Return of Medically Relevant Information

An issue related to informed consent is how much information to provide to survey participants once their biological specimens have been analyzed and in particular, how to deal with medically relevant information that may arise from the analysis. What, for example, should a researcher do if a survey participant is found to have a genetic disease that does not appear until later in life? Should the participant be notified? Should participants be asked as part of the initial interview whether they wish to be notified about such a discovery? At this time, there are no generally agreed-upon answers to such questions, but researchers should expect to have to deal with these issues as they analyze the data derived from biological specimens.

Recommendation 15: NIH should direct investigators to formulate a plan in advance concerning the return of any medically relevant findings to

survey participants and to implement that plan in the design and conduct of their informed consent procedures.

INSTITUTIONAL REVIEW BOARDS

Investigators seeking IRB approval for biosocial research face a number of challenges. Few IRBs are familiar with both social and biological science; thus, investigators may find themselves trying to justify standard social science protocols to a biologically oriented IRB or explaining standard biological protocols to an IRB that is used to dealing with social science—or sometimes both. Researchers can expect these obstacles, which arise from the interdisciplinary nature of their work, to be exacerbated by a number of other factors that are characteristic of IRBs in general (see Chapter 4 ).

Recommendation 16: In institutions that have separate biomedical and social science IRBs, mechanisms should be created for sharing expertise during the review of biosocial protocols. 5

What Individual Researchers Need to Do Regarding IRBs

Because the collection of biospecimens as part of social science surveys is still relatively unfamiliar to many IRBs, researchers planning such a study can expect their interactions with the IRB overseeing the research to involve a certain learning curve. The IRB may need extra time to become familiar and comfortable with the proposed practices of the survey, and conversely, the researchers will need time to learn what the IRB will require. Thus it will be advantageous if researchers conducting such studies plan from the beginning to devote additional time to working with their IRBs.

Recommendation 17: Investigators considering collecting biospecimens as part of a social science survey should consult with their IRBs early and often.

What Research Agencies Should Do Regarding IRBs

One way to improve the IRB process would be to give members of IRBs an opportunity to learn more about biosocial research and the risks it entails.

This could be done by individual institutions, but it would be more effective if a national funding agency took the lead (see Recommendation 14).

It is the panel’s hope that its recommendations will support the incorporation of social science and biological data into empirical models, allowing researchers to better document the linkages among social, behavioral, and biological processes that affect health and other measures of well-being while avoiding or minimizing many of the challenges that may arise. Implementing these recommendations will require the combined efforts of both individual investigators and the agencies that support them.

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Recent years have seen a growing tendency for social scientists to collect biological specimens such as blood, urine, and saliva as part of large-scale household surveys. By combining biological and social data, scientists are opening up new fields of inquiry and are able for the first time to address many new questions and connections. But including biospecimens in social surveys also adds a great deal of complexity and cost to the investigator's task. Along with the usual concerns about informed consent, privacy issues, and the best ways to collect, store, and share data, researchers now face a variety of issues that are much less familiar or that appear in a new light.

In particular, collecting and storing human biological materials for use in social science research raises additional legal, ethical, and social issues, as well as practical issues related to the storage, retrieval, and sharing of data. For example, acquiring biological data and linking them to social science databases requires a more complex informed consent process, the development of a biorepository, the establishment of data sharing policies, and the creation of a process for deciding how the data are going to be shared and used for secondary analysis--all of which add cost to a survey and require additional time and attention from the investigators. These issues also are likely to be unfamiliar to social scientists who have not worked with biological specimens in the past. Adding to the attraction of collecting biospecimens but also to the complexity of sharing and protecting the data is the fact that this is an era of incredibly rapid gains in our understanding of complex biological and physiological phenomena. Thus the tradeoffs between the risks and opportunities of expanding access to research data are constantly changing.

Conducting Biosocial Surveys offers findings and recommendations concerning the best approaches to the collection, storage, use, and sharing of biospecimens gathered in social science surveys and the digital representations of biological data derived therefrom. It is aimed at researchers interested in carrying out such surveys, their institutions, and their funding agencies.

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Institute of Medicine (US) Committee on Serious and Complex Medical Conditions; Chrvala CA, Sharfstein S, editors. Definition of Serious and Complex Medical Conditions. Washington (DC): National Academies Press (US); 1999.

Cover of Definition of Serious and Complex Medical Conditions

Definition of Serious and Complex Medical Conditions.

  • Hardcopy Version at National Academies Press

3 Conclusions and Recommendations

  • Introduction

Throughout the course of this study, the committee has been extremely aware of the fact that the topic addressed by this report concerns one of the most critical issues confronting HCFA, health care plans and providers, and patients today. The Medicare+Choice regulations focus on the most vulnerable populations in need of medical care and other services—those with serious or complex medical conditions. Caring for these highly vulnerable populations poses a number of challenges.

In the absence of a fully developed research and clinical knowledge base, combined with the time and resource constraints of this study, the committee chose what it believes is the most prudent and thoughtful approach to its charge. Specifically, the committee has chosen to provide guidance to HCFA and health care plans to support initial steps to address the major issues confronting health care plans and their beneficiaries with serious and complex medical conditions. This guidance is supported by presentation of possible strategies that might be used to screen enrollees for the presence of serious and complex medical conditions. Health care plans are encouraged to be innovative in their initial efforts to develop case-screening methodologies. As plans develop experience with different screening modalities, information can be shared nationally. It is the committee's intent that this will lead to the identification of best practices and subsequent standardized methods for ongoing screening of beneficiaries for serious and complex conditions. The committee also recommends strategies to ensure that the care offered to persons with serious and complex conditions is responsive to the diverse, multidisciplinary needs for services to address a full spectrum of medical, social, and mental health issues. Finally, the committee feels strongly that evaluation and research efforts must occur simultaneously with the implementation of the guidance and recommendations concerning screening and care of patients with serious and complex medical conditions. As HCFA and health care plans develop the necessary expertise and resources to provide comprehensive, multidisciplinary care to patients with serious and complex conditions, this knowledge can be generalized to address the needs of patients with serious but not complex and complex but not serious medical conditions. The following conclusions and recommendations are based on consideration of these diverse issues.

Recommendation 1: The establishment of an administrative definition for serious and complex medical conditions by the Health Care Financing Administration would be premature at this time.

It is the opinion of the committee that the current state of clinical and research literature does not support development of an operational definition for serious and complex medical conditions. There are a large number of potential ways to screen and identify patients with serious and complex medical conditions, although each has its own set of limitations. Disease classification systems such as diagnosis-related groups, diagnostic cost groups, and the International Classification of Diseases—Ninth Edition lack the sensitivity and specificity required to effectively distinguish between patients with acute care needs and those who need more extensive treatment and service arrays. The validity of patient classifications systems (e.g., diagnosis-related groups) and functional status definitions (e.g., Karnofsky and SF-36 scales) has not yet been determined. Efforts to develop case-mix-adjusted reimbursement systems to ensure cost-effectiveness and high-quality interventions for patients with serious and complex conditions are still in the early stages or are limited to only a single disease category. Similarly, efforts to develop standardized protocols for care coordination, continuity of care, care management strategies, and service reimbursement plans have met with varying degrees of success.

Clinical research relevant to defining patient populations as having serious and complex conditions and developing the most effective care protocols to respond to patient needs is evolving rapidly, but only preliminary results are available. For example, research in correlating patient volume with patient outcomes, differentiating access to services as a function of health plan benefits, and addressing variations in quality of care has just begun to yield meaningful results about particular groups of patients. The committee anticipates that this research will continue to evolve and will provide more definitive conclusions to guide the efforts of health plans to identify patients with serious and complex medical conditions and ensure appropriate levels of treatment and care management. As the science base is strengthened, so too will be the ability of HCFA and health plans to correctly identify patients with serious and complex medical conditions who would benefit from broad strategies of care management.

Recognizing these limitations, the committee recommends that plans first focus their attentions on patient populations with conditions that are serious AND complex. These conditions are described as persistent, substantially disabling or life threatening that require treatments and interventions across a broad scope of medical, social, and mental health services. Plans will require time to develop expertise and resources to develop methods of case finding and provision of an integrated care management approach for these patients. As such expertise is developed and resources are allocated, plans can then expand their efforts to include patients with serious but not complex conditions and those with complex but not serious conditions.

Recommendation 2: The committee recommends that the Health Care Financing Administration should provide guidance to health plans to assist their efforts to identify patients with serious and complex medical conditions. Specifically, the committee recommends the following language be used to facilitate efforts of plans to identify their enrollees with ''serious and complex conditions": "A serious and complex condition is one that is persistent and substantially disabling or life threatening that requires treatments and services across a variety of domains of care to ensure the best possible outcomes for each unique patient of member."

The committee recognizes the importance at this time of providing health plans with guidance to facilitate operationalization of their own definitions of serious and complex medical conditions. This guidance includes a description of a serious and complex medical condition as one that is persistent and substantially disabling or life threatening that requires treatments and services across a variety of domains of care. The committee reviewed a number of possible categories of conditions that might be considered serious and complex. These are discussed in Chapter 1 of this report and include, but are not limited to, life-threatening conditions, conditions that cause serious disability without necessarily being life threatening, conditions associated with severe consequences, conditions affecting multiple organ systems, conditions requiring coordination of management by multiple specialties, and conditions requiring treatments that carry a risk of serious complications.

Clinical research to identify patient populations with serious and complex medical conditions and develop the most effective care management strategies to respond to patient needs is evolving rapidly, with only preliminary results available. The current state of clinical and research literature does not adequately address all of the challenges and issues relevant to the identification and care of these patients. These issues include, but are not limited to, identification of methods and criteria that can be applied to screen enrollees for the presence of serious and complex conditions; development of strategies for proper care and management of the complex array of medical, social, and mental health problems confronting these patients; development of strategies to evaluate the effectiveness, efficacy, and efficiency of different strategies of care management; and ongoing research to ensure continuous improvements in the care of patients. Health care service research is only beginning to emerge with initial findings relevant to these issues.

The committee anticipates that this research will continue to evolve and provide more definitive conclusions to guide the efforts of health plans to identify patients with serious and complex medical conditions and help plans to provide appropriate levels of treatment and care management. The committee urges health care plans, in collaboration with federal agencies and research institutions, to support this ongoing research and facilitate a synthesis of emerging results. As the science base is strengthened, so too will be the ability of HCFA and health plans to correctly identify patients who would benefit from a broad care management strategy including those with serious but not complex or complex but not serious conditions.

Recommendation 3: The committee recommends that health plans develop a broad strategy for care management to enable patients and providers to achieve the best possible outcomes for each unique patient or member with a serious or complex medical condition.

This care management strategy should include, but not necessarily be limited to, case finding; screening and selection; problem assessment and identification of strengths; development of treatment or care plans; implementation of care plans with an emphasis on proactive interventions; and monitoring of care plan implementation and outcomes.

The treatments for individuals with serious and complex medical conditions will inevitably vary due to many factors, including characteristics of the individual patient and the patient's social situation, characteristics of individual providers, provider organizations, health plans, resources in the community, health plan benefits, and so forth. Although these factors will vary for all patients, they have less impact on preventive care (e.g., immunizations) and acute care (e.g., setting a broken arm) interventions. Successful outcomes for persons with serious and complex medical conditions will rely on a diverse mix of medical, social, functional, financial, and psychological factors, as well as on how these factors mesh with a community's health and social services resources. There is no single guideline that can prescribe the care or treatments for persons with serious and complex medical conditions.

The committee's recommendations concerning elements of the care management strategy have been derived, in part, from existing publications (Case Management Society of America, 1996; HMO Workgroup on Care Management, 1999). A brief explanation for each of the recommended steps in the care process is provided below.

Case finding refers to methods for identifying persons who may have a serious and complex medical condition. Utilization of the committee's recommended description for serious and complex conditions can facilitate efforts by health plans and providers to identify possible categories of patients for whom case finding should be conducted. Depending on the organization of a health plan and its provider group(s), case finding methods may include electronic searching of administrative databases; phone screening of new or existing members; referral by patient or family member; referral by a clinician or other professional; or notification by an emergency room, hospital, nursing home, or other provider organization.

Case screening and selection outline a process for deciding exactly which patients meet a plan's criteria for serious and complex medical conditions. These criteria should be established by each health plan with review by HCFA. Examples of selection criteria might include factors such as diagnostic codes, patient age, presence of comorbidities, severity of illness or disability, duration of a disability, and so forth. It is expected that patients meeting these criteria would benefit from coordinated care management.

The next step in the care process should involve an assessment of the patient's problems and strengths. This is a tool for gathering information about the patient's medical, social, functional, and financial status that will be used to further determine his or her need for care management and the resources available to access the necessary services.

Treatment or care planning is also recommended by the committee as an essential element of a care management strategy for patients with serious and complex medical conditions. Such planning supports the development of individualized, goal-focused care plans (based on assessment findings and drawing on evidence-based treatments when available) to provide a guide for delineating patient, provider, and plan responsibilities for accessing and coordinating needed services.

The care management strategy also demands that steps be taken to ensure the implementation of care plans. Execution of the care management plan includes strategies and tactics for providing or purchasing needed services, or for linking patients to covered services, services available in the community, or those for which the patient will have to pay. It also includes advocating for the provision of informal services by family, friends, and neighbors.

The final step of the care process is monitoring implementation and outcomes of the care management strategy. This can be based upon periodic reviews of a patient's status and treatments to determine whether goals are being achieved, whether interventions and treatments continue to be appropriate, whether there is a medical need for continued services, or whether proactive care is required to address potential or emerging new problems. This type of monitoring can also include measurements to assess the impact of care management and treatment on clinical, functional, cost, and satisfaction outcomes.

Throughout the entire care management strategy for persons with serious and complex medical conditions, three principles should be evident. First, the care management strategy should reflect a commitment to continuity and coordination of care, as described among the requirements for National Committee for Quality Assurance accreditation. This entails monitoring continuity and coordination activities, analyzing data to identify opportunities for improvement, and taking actions to bring about improvements, as indicated. Second, the care process should include multidisciplinary perspectives and treatments, as appropriate. The care of persons with serious and complex medical conditions may require the assessment and treatment expertise of primary care providers; medical and surgical specialists; nurses and nurse specialists; social workers; pharmacists; occupational, speech, and physical therapists; behavioral and mental health professionals; and community-based service providers and resources. Access to expertise from these various disciplines should be available as needed. Third, and perhaps most important, patients and their family members should be involved at every step so that the care process incorporates the patient's expectations and preferences and documents the patient's role in achieving treatment goals.

The committee's recommendations concerning the care management process for patients with serious and complex conditions assumes patient willingness to collaborate with a multidisciplinary team of providers in the development and implementation of that plan. In those instances where a patient or family member declines such participation, appropriate documentation should be entered into the patient record. The presence of such documentation should be considered by HCFA as evidence that a good faith effort has been made by the plan to involve the patient and family in the development of the case management plan.

Recommendation 4: The committee recommends that health plans design and implement strategies for routine screening and selection to identify those beneficiaries with serious and complex medical conditions. These strategies should be consistent with the guidance outlined in Recommendation 2 to determine which patients meet a plan's threshold for serious and complex medical conditions and would benefit from a coordinated care management strategy.

The committee recommends that health plans identify specific categories of patients or health conditions for which screening for the presence of serious and complex conditions should occur on a routine basis. Examples of such categories are provided in Chapter 1 . The committee is of the opinion that screening a health care plan's entire population of enrollees is not a feasible, cost-effective, or efficient method of identifying subpopulations with serious and complex medical conditions. The committee feels strongly, however, that early efforts to develop case-screening methodologies should not be prescriptive; rather, innovation should be encouraged. Documentation of locally derived methods by plans will result in extensive nationwide experience that can be assessed and can lead to the identification of best practices and subsequent standardized methods for ongoing routine screening of patient populations.

The appropriate application of resources by a health plan to patients with serious and complex medical conditions requires the identification of those individuals whose health outcomes would benefit by such designation. For the purposes of this report, the committee has not included patients suffering from acute conditions that might require coordinated delivery of sophisticated medical services to treat complications of acute decompensation. On the other hand, many patients who have endured prolonged hospitalization for an acute medical condition may subsequently need coordinated long-term care to maximize their rehabilitation potential; to treat persistent sequelae of the disease processes that resulted from the acute, severe illness; and to ensure that they receive proactive care to prevent further exacerbation of the illness or disability.

Conceptually, various methodologies could be applied to administrative databases that could produce relevant lists of patients with serious and complex medical conditions who would be likely to benefit from written care management plans. High-cost patients, for example, might merit designation as having serious and complex conditions. Some of these individuals, however, may have undergone a single event such as bypass surgery that is self-limited and not appropriate for such designation. In contrast, others will have conditions, such as organ transplants, disabling traumatic injury, and HIV/AIDS, that clearly require ongoing medical attention and resources to sustain or improve their health status. Aside from costs, certain diagnostic entities could be identified for designation as serious and complex medical conditions. Examples of such entities could include progressive, degenerative disorders, active collagen vascular disease, and metastatic cancers. The committee does not believe it is feasible at this time to create an all-encompassing list of diagnoses appropriate for designation as serious and complex conditions. Indeed, within any diagnostic label, there exists a continuum of disease and disability that requires varying degrees of medical and other health-related support.

Beneficiary survey tools could supplement the use of administrative data sets to identify appropriate patients. Questionnaires that quantify functional status could assist plans in capturing individuals who need special attention in the outpatient setting to improve or sustain functional capacity or physiological stability. Similarly, home health agencies or medical professionals could identify frail elderly patients who require care management to sustain homeostasis. These agents could refer patients' names to health plans for development of a formal management program for serious and complex medical conditions. Such patients could include those of advanced age (over 85) with several comorbid medical conditions such as congestive heart failure, chronic renal failure, and diabetes. These persistent conditions in concert with reduced cognitive functioning or physical capacity to sustain daily living activities produce a constellation of physiological deficits that require supportive health care services for the patient to maintain independent living in a community setting.

There are several reasons why it is essential to the care of persons with serious and complex medical conditions that screening and selection of a plan's designated patient categories or conditions occur on a routine basis. First, periodic screening allows the multidisciplinary care team to adjust the care management approach as patient needs change over time. Second, routine screening is necessary to identify new patients with serious and complex medical conditions. Third, it ensures that persons who are no longer considered to have a serious and complex condition will be identified and services adjusted accordingly, which could result in a cost benefit.

The committee believes that over time, the health care system will identify reliable, accurate screening techniques for populations of patients with serious and complex medical conditions. In many cases, timely identification will permit appropriate treatment at the level of the primary care provider. Nevertheless, even with robust methodologies in place, there will be patients and families who believe that they require additional resources or attention to adequately manage a persistent health condition. In instances in which a treatment plan is not mutually agreeable, individuals should be able to appeal to the medical director of the provider group or health plan. The review process should be timely and should allow for both internal and independent external review.

Recommendation 5: The committee recommends that health care plans develop a care management strategy that integrates the participation of all those involved in the care of the patient, including primary care physicians; medical and surgical specialists; nurses and nurse specialists; behavioral and mental health specialists; physical, occupational, and speech therapists; social workers; allied health professionals; and community-based service providers.

The development of a collaborative care management strategy involving all those who participate in providing care to the individual patient is critical to the treatment of patients with serious and complex conditions. The treatment plan serves several important functions within the care management strategy. First, it provides a road map and a guide to indicate direction of and demarcate landmarks in care management, making it easier to ensure that all providers involved in the patient's care share the same goals, and that these goals are accessible to the patient and the patient's family. Second, it provides a way to measure progress and the achievement of care goals, and it serves as a powerful communication and coordination tool among the participants involved in the care of the patient, avoiding overlapping or redundant efforts as well as gaps and inattention to components of care assumed to be the responsibility of others on the care team. Third, a treatment plan offers an opportunity to delineate which provider is taking responsibility for specific aspects of care.

Although there is currently no evidence to support the identification of a single format or model as superior to all others, the committee feels confident in recommending certain key components that should be part of any treatment plan for patients with serious and complex medical conditions. Specifically, the plan should involve the collaborative participation of all those taking part in the care of the patient, including primary care physicians; medical and surgical specialists; nurses and nurse specialists; physical, occupational, and speech therapists; rehabilitation specialists; behavioral and mental health specialists; social workers; allied health professionals; and community-based service providers and resources.

The perspectives, health beliefs, and values of the patient and the patient's family should be taken into consideration, and the care management plan should be constructed in a culturally appropriate manner. Elements of the care management plan should be appropriate both for the age or life phase of each patient as well as the stage or severity of the health condition. This will ensure selection of treatment options that are responsive to the unique needs of patients of different age groups and with conditions of varying severity. The patient should be involved in the development of the plan and should have access to the plan.

The plan should be linked to relevant clinical practice guidelines and should reflect the process of adapting population-based clinical practice guidelines to the unique care and service needs of the individual. The treatment plan should cross areas of expertise and should address the need for coordination of care across the continuum of care delivery settings. The plan should be longitudinal, with accommodations for proactive interventions to prevent potential problems from arising, and it should also enable longitudinal assessment of outcomes. The treatment plan should be a living document that is periodically reviewed, updated, and tested for continuing relevance to the patient's circumstances (e.g., the life phase) and clinical condition (e.g., the disease stage).

Recommendation 6: The committee recommends that health care plans have programs in place to monitor care management plans for both process and outcomes for patients with serious and complex conditions at the level of population, patient, provider, and best practices of care .

The Health Care Financing Administration should establish a formal mechanism to evaluate a Medicare+Choice provider organization's program to monitor the outcomes of care for patients with serious and complex medical conditions. The committee recognizes that the monitoring and evaluation programs will vary between health plans but recommends that all programs include population-based monitoring of the outcomes of care for patients with serious or complex conditions, as well as individual case monitoring, assessment of provider interventions, and evaluation of best practices of care.

Assessment of population-based measures may include, but not be limited to, review of plan-wide policies and procedures; application of working definitions of serious and complex conditions; adoption of evidence-based clinical guidelines; review of health outcomes survey, patient satisfaction and complaint data; and review of clinical outcomes data for patients with serious or complex medical conditions. Individual case monitoring may include, but not be limited to, analysis of complaint data, patient satisfaction, internal and external appeals of the care plan, and overturned denials. Evaluation and monitoring at the level of providers will include efforts to assess clinical quality of care, timeliness of care, and effectiveness of specific interventions. Best practices of care will be identified by data that describe clinical, functional, and patient satisfaction outcomes.

Recommendation 7: The committee recommends that the Health Care Financing Administration collaborate with federal, private, and voluntary agencies, organizations, and consumers to establish an ongoing process to address policy issues to ensure continuous improvements in the care of populations with serious and complex medical conditions .

Access to providers with the appropriate training and expertise is important, but other issues must be addressed to ensure that beneficiaries with serious and complex conditions achieve the best possible outcomes. The committee recognizes that a number of these issues supersede activities that can be accomplished at the level of individual health plans. Issues that must be addressed include, but are not limited to, the following:

• Payment.

The current Medicare capitated payment mechanisms for health plans are not risk adjusted and are derived from experience in the fee-for-service sector. These payment mechanisms may not provide adequate compensation to some health plans. Furthermore, health plans use a variety of methods to compensate individual providers and hospitals. Greater attention should be focused on the improved alignment of financial incentives at all levels to ensure appropriate payment for serious and complex cases through adequate funding and risk-adjusted payment systems.

• Benefits.

Improving the care of persons with serious and complex medical conditions can be supported by ensuring that Medicare beneficiaries can choose among different health plans. When beneficiaries have multiple affordable options, they can select based upon their own evaluations of quality. Where benefits are provided through multiple payment programs (i.e., Medicare and Medicaid dual eligibles), coordination of benefit packages and eligibility requirements is critical. The movement of patients with serious and complex conditions into managed care holds the promise of greater health for these patients and therefore reduced expenditures for Medicaid programs due to reduced nursing home use. Prescription coverage for these patients would result in a direct reduction in state Medicaid prescription coverage expenses. Medicare requirements for management of patients with serious and complex conditions may also serve as the future basis for Medicaid managed care contracts.

• Medicaid and Medicare Fee-for-Service Programs.

The committee was unable to address the third point of its charge with any degree of thoroughness. This is primarily due to the fact that the committee lacked sufficient information and time to conduct informed deliberations about the implications of alternative definitions for serious and complex medical conditions for Medicaid and commercial programs, especially when applied to Medicare beneficiaries who are dual eligible. The committee strongly recommends that HCFA, in collaboration with Medicare and Medicaid provider plans, establish this as a research priority. Resources and expertise should be allocated to conduct a study to define the relevant issues and generate possible approaches to address this question.

In the meantime, the committee suggests that the basic guidance provided in this report concerning the description of serious and complex medical conditions and recommendations concerning strategies for care management for this patient population should be extended to include Medicaid beneficiaries and those that are dual eligible. In addition, this guidance should apply to patients enrolled in fee-for-service Medicare programs. This should be a priority area for collaborative research on policy issues to ensure continuous improvements in the care of populations with serious and complex medical conditions covered by Medicaid and fee-for-service Medicare plans.

• Consumer Education and Participation.

Many patients, especially those with persistent and disabling conditions, are ready and able to become more active participants in the care delivery process. Attempts should be made to increase patient participation in clinical decision-making and caregiving processes consistent with improving clinical outcomes and satisfaction.

• Professional Training.

To serve persons with serious and complex medical conditions, an aggressive strategy must be developed to educate and train health professionals to provide appropriate care for this population. There is currently a great undersupply of persons trained in care management processes, multidisciplinary team care, geriatrics, patient education and self-management, and cultural competence.

• Information Technology.

More sophisticated information technology is required to provide high-quality, coordinated care to those with complex or serious medical conditions. More sophisticated information systems are needed to support efforts to monitor, analyze, and improve patient care. Continued development of electronic medical records will be an important factor in ensuring that all health care organizations and providers involved in the care of a patient have timely access to complete information on the patient's clinical conditions, diagnostic and therapeutic test results, and services received. Confidentiality protections must be respected throughout the process of technology development.

• Regulatory Framework.

Developing a regulatory approach for the Medicare+Choice program that affords adequate protections for beneficiaries with serious and complex medical conditions while encouraging innovation in a rapidly changing health care environment will be an ongoing challenge. Periodic evaluation and modification will be essential.

• Applied Research.

Research is needed to further inform the policy process and to identify best practices in the care of patients with serious and complex conditions. Attention should be focused on the following areas: effects of benefits coverage and payment methods on care delivery; determination and dissemination of best practices in the identification of patients with serious and complex conditions; efficacy, effectiveness, and efficiency of multidisciplinary teams; use of information technology to support care coordination and delivery; and development of innovative methods of designing, implementing, and coordinating medical, social, and other services.

These and related issues will require HCFA to actively collaborate with all types of payors, health care plans, providers, research organizations, and consumer and disability groups to develop strategies and solutions that will maximize the quality of health care and other services for patients with serious and complex medical conditions.

  • Conclusions

The needs of patients with serious and complex medical conditions far exceed the boundaries of a single issue such as access to specialists for care. For health care delivery systems to provide high-quality, effective care for these patients, the systems must be responsive to a diverse array of clinical, social, mental, and functional health issues. The development of a health care delivery system that will provide quality and effective care for these patient populations must be responsive to a diverse group of clinical, social, mental, and functional health issues. The health care delivery system must also be capable of working effectively with other community and social support systems.

The questions raised by HCFA concerning implementation and regulations for the Medicare+Choice program apply broadly to include all health care delivery and payment systems, including fee-for-service care. This study is one of the first to address these complex and extremely important topics. Thus, the committee urges HCFA, health care plans, and consumer groups to view this report, and especially its conclusions and recommendations, as first steps in the effort to address the unique and complicated needs of persons with serious and complex medical conditions and to ensure that they receive the most cost-effective and best-quality care possible. The work of this committee is intended to support and provide direction for future work to be conducted by HCFA, in collaboration with all types of health care plans and consumer organizations, to design innovative strategies to ensure adequate reimbursement, access to broad care management, and the highest possible quality of treatment services required by patients with serious and complex medical conditions.

  • Cite this Page Institute of Medicine (US) Committee on Serious and Complex Medical Conditions; Chrvala CA, Sharfstein S, editors. Definition of Serious and Complex Medical Conditions. Washington (DC): National Academies Press (US); 1999. 3, Conclusions and Recommendations.
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