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Reporting the Review
- 1. Reporting the Review Prepared for: The Agency for Healthcare Research and Quality (AHRQ) Training Modules for Systematic Reviews Methods Guide www.ahrq.gov
- 3. Systematic Review Process Overview
- 26. Examples of Flow Diagrams Fuccio L, et al. Ann Intern Med 2007;147:53-62. Reprinted with permission from the American College of Physicians. Sharma M, et al. Ann Intern Med 2009:151:622-30. Reprinted with permission from the American College of Physicians.
Notas do Editor
- Reporting the Review
- Learning Objectives This module has been prepared to help authors of comparative effectiveness reviews ensure that their reports are of the highest possible quality. When authors do not provide sufficient details concerning the conduct of their study, readers are left with an incomplete picture of what was done. As such, they are not able to judge the reliability of the results or interpret them. There are two learning objectives for this module. The first one is to describe the various elements that need to be reported upon completion of the review. The second one is to distinguish examples of reporting that are adequate from those that are inadequate. The examples in the subsequent slides are of adequate reporting.
- Systematic Review Process Overview This slide illustrates the steps in the systematic review process. This module focuses on reporting the review, which is more than simply presenting the findings. Reporting the results of a systematic review includes, for example, information on the number of databases searched, the number of records screened, and the complete methods and results.
- Writing the Report Authors should use a standard template (guidance) for the overall report. The purpose of using a standard template is to make reading and understanding of the report easier for readers. The subsections in the report may vary. Using the PICOTS framework (population, intervention, comparator, outcome, timing, and study design or setting) can help guide the construction. Subsequent slides will provide more details about the framework’s use. Note: In this module, “PICOTS” is used for the purposes of consistency. The basic framework, PICO is used in all five steps of conducting a systematic review: preparing the topic, searching for and selecting studies, abstracting data, presenting findings, and reporting the review. In order to understand the review topic or question, the Evidence-based Practice Center investigators must identify the relevant Population, the Intervention, the Comparison, and the Outcome of interest. PICOTS, or PICO(TS), includes two other elements — timing and setting — that are sometimes included as part of the other study criteria or are called out specifically to bring attention to these items. For example, the timing of the outcome assessment may be included with the outcome (PICOT); but if timing is not specified clearly, investigators may forget to define it. The “S” in PICOS or PICOTS usually represents setting but occasionally (as in the modules on quantitative synthesis and the reporting of the review) it is used to refer to the study design. The setting encompasses issues of both population (hospital populations have different characteristics than those in outpatient clinics) and the intervention (particularly for behavioral or surgical interventions in which service delivery may vary greatly in different settings). In preparing their report, authors should use the framework they employed during the first four steps of their systematic review process.
- Systematic Review Report Structure (I) This slide shows the first three of the five major sections of the standard template used in a systematic review report. The structure of the review report, particularly for comparative effectiveness reviews, will include an abstract and an executive summary. Some readers will read only the abstract and executive summary, so particular focus and attention should be given to this section.
- Systematic Review Report Structure (II) This slide shows the last two of the five major sections of the standard template used in a systematic review report.
- Using Formal Guidelines To Improve the Reporting of Systematic Reviews International guidelines have been developed to help improve the quality of research reporting. The PRISMA Statement is an example of reporting guidelines especially developed to help authors report systematic reviews. These guidelines consist of a checklist and a flow diagram that can be downloaded from the PRISMA Web site. References: PRISMA Statement Web site. Home page. Available at: http://www.prisma-statement.org/index.htm . Liberati A, Altman DF, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Ann Intern Med 2009;151:W65-94. http://www.ncbi.nlm.nih.gov/pubmed/19622512 David Moher, Alessandro Liberati, Jennifer Tetzlaff, Douglas G Altman for the PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 2009;339:b2535 http://www.ncbi.nlm.nih.gov/pubmed/ 19622552
- Title of the Review Report In the title of the report, it is important to identify the type of review — a systematic review, a meta-analysis, or a comparative effectiveness review — that was conducted. It is also important to remember that the title needs to be understandable to readers of the report. Consider these examples. The first example, “Comparative Effectiveness of Lipid-Modifying Agents,” does not provide much detail. It is simple and gives a higher level overview of what the review is about. Very often, this type of title is sufficient for the audience. The second example, ”Mortality in Randomized Trials of Antioxidant Supplements for Primary and Secondary Prevention: Systematic Review and Meta-analysis,” is more detailed and provides a more information for readers. Both examples are reasonable. When developing the title, as in many other aspects of the report, the PICOTS framework can be used as a guide.
- Executive Summary (I) Although the review team may work hard to develop a 100-page report, not everyone will have the time to read it. Because the executive summary may be used for decisionmaking by individuals who do not have time to read the full report, it is important that it be well-organized, as illustrated on this slide. It should include the background to the review, the review objectives, the key research questions, and the methods, which also might include the data sources, the eligibility criteria, the study appraisal, and the synthesis methods. The results, limitations, and conclusions, including the implications of key findings, should also be included.
- Executive Summary (II) The executive summary is meant to be a distillation of the entire review report and should not include study-by-study results. It should provide an overall summary of the review and describe the evidence that supports the summary statements. It is important to describe the strength of the evidence, as was categorized in the evidence review.
- Introduction: Purpose and Scope In the introductory section of the document, it is important to share with the reader the purpose and scope of the review, including the clinical decisional dilemma, the current literature, and the current state of practice. Providing this information gives the reader context, which is extremely important. The next step is to provide information about the objectives and the key questions that the evidence review will address. It might be helpful at this point to use the PICOTS framework to describe the objectives and state the key research questions.
- Methods Overview Ideally, research methods are detailed in a preexisting protocol (and any subsequent amendments), which is typically prepared by Evidence-based Practice Center investigators in advance of a systematic review. In this report, the Methods overview should provide information on literature search strategy and data sources, eligibility criteria, and data collection processes and data items. The Methods overview should also provide information on quality assessment and synthesis of results, grading of evidence and additional analysis methods. The information should be provided in as clear and transparent a manner as possible. Using the PICOTS framework might be helpful in considering what to include. A point to be noted on writing style: this section of the review should be written in the past tense.
- Methods: Literature Search All systematic reviews conducted by Evidenced-based Practice Centers must present the complete electronic search strategy in the Appendix. The purpose of including the entire search strategy is to ensure transparency and to permit replication of the review. Reference : Alejandria MM, Lansang MA, Dans LF, et al. Intravenous immunoglobulin for treating sepsis and septic shock. Cochrane Database Syst Rev 2002;(1):CD001090. http://www.ncbi.nlm.nih.gov/pubmed/11869591
- Methods: Information Sources All information sources used in the literature search — including the databases used, dates covered in each database, and any contacts with authors — should be reported. This slide shows an example of how this information is reported. Reference : Bolen S, Wilson L, Vassy J, et al. Comparative Effectiveness and Safety of Oral Diabetes Medications for Adults With Type 2 Diabetes . Comparative Effectiveness Review No. 8 (Prepared by The Johns Hopkins University Evidence-based Practice Center under Contract No. 290-02-0018). Rockville, MD: Agency for Health Care Research and Quality, July 2007. AHRQ Publication No. 07-EHC010-EF. Available at: http://www.effectivehealthcare.ahrq.gov/ehc/products/6/39/OralFullReport.pdf.
- Methods: Eligibility Criteria (I) Authors of systematic reviews should report the processes by which they selected studies for analysis. Specifically, they should explain how the studies were screened for inclusion or exclusion and which eligibility criteria were applied. The brief example on this slide shows the level of detail that authors should provide in a report. This level of detail is needed ensure transparency and to permit replication of the review. Reference : Shah MR, Hasselvlad V, Stevenson LW, et al. Impact of the pulmonary artery catheter in critically ill patients: meta-analysis of randomzied clinical trials. JAMA 2005;294:1664-70. http://www.ncbi.nlm.nih.gov/pubmed/16204666
- Methods: Eligibility Criteria (II) This slide offers examples of how studies and participants were described in the methods section of a published report. The PICOTS (population, intervention, comparator, outcome, timing, and study design or setting) framework can serve as a guide for reporting the eligibility criteria of the review. Specifically, the type of study, the types of participants, the type of intervention, and the type of outcome should be reported. This ensures that readers, such as clinicians, can determine if the review results can be generalized to their patient population. It is also important to provide this information clearly so that anyone who would like to replicate the review are able to do so. Reference: Schroth RJ, Hitchon CA, Uhanova J, et al. Hepatitis B vaccination for patients with chromic renal failure. Cochrane Database Syst Rev 2004;(3):CD003775. http://www.ncbi.nlm.nih.gov/pubmed/15266500
- Methods: Eligibility Criteria (III) This slide offers examples of how interventions and outcomes were described in the methods section of a published report. The PICOTS (population, intervention, comparator, outcome, timing, and study design or setting) framework can serve as a guide for reporting the eligibility criteria of the review. This ensures that readers, such as clinicians, can determine if the review results can be generalized to their patient population. It is also important to provide this information clearly so that anyone who would like to replicate the review are able to do so. Reference : Schroth RJ, Hitchon CA, Uhanova J, et al. Hepatitis B vaccination for patients with chromic renal failure. Cochrane Database Syst Rev 2004;(3):CD003775. http://www.ncbi.nlm.nih.gov/pubmed/15266500
- Methods: Data Extraction Authors should describe the method used for extracting data from the studies selected for the review. The level of detail that should be included in the description of the data collection process is illustrated in the example on this slide. Authors should also describe any processes they followed to obtain and confirm any information they received from the authors of the primary studies. Once again, the goal is to ensure transparency and to permit replication of the review. Reference Mistiaen P, Poot E. Telephone follow-up, initiated by a hospital-based health professional, for postdischarge problems in patients discharged from hospital to home. Cochrane Database Syst Rev 2006;(4):CD004510. http://www.ncbi.nlm.nih.gov/pubmed/17054207
- Methods: Data Items Authors should list and define all the variables for which data were sought. The PICOTS (population, intervention, comparator, outcome, timing, and study design or setting) framework can be used as a guide. In addition, authors should describe any assumptions and simplifications that were made in defining the variables. Following this approach will make the report clear and ensure transparency. Reference : Allen C, et al. Non-steroidal anti-inflammatory drugs for pain in women with endometriosis. Cochrane Database Syst Rev 2005;(4):CD004753. http://www.ncbi.nlm.nih.gov/pubmed/16235379
- Methods: Quality Assessment Authors should describe the methods and criteria they used to assess the quality (risk of bias) of the studies selected for the review. As noted in the previous slides on methods, authors should provide a certain level of detail about the approaches they used for quality assessment. This information helps to ensure transparency and to permit replication of the review. References: Tracz MJ, Sideras K, Boloña ER, et al. Testosterone use in men and its effects on bone health. A systematic review and meta-analysis of randomized placebo-controlled trials. J Clin Endocrinol Metab 2006;91:2011-6. http://www.ncbi.nlm.nih.gov/pubmed/16720668 Bucher HC, Hengstler P, Schindler C, et al. Percutaneous transluminal coronary angioplasty versus medical treatment for non-acute coronary heart disease: meta-analysis of randomised controlled trials. BMJ 2000;321:73-7. http://www.ncbi.nlm.nih.gov/pubmed/10884254
- Methods: Synthesis of Results Authors should describe the methods they used to handle the data and to combine the results of studies. If measures of consistency, such as an I-squared test, were used, the results should be reported for each meta-analysis. This level of detail will also be helpful to ensure transparency and to permit replication of the review. This slide shows two examples of descriptions of methods used for synthesizing data. References: Jones M, Schenkel B, Just J, et al. Epoetin alfa improves quality of life in patients with cancer: results of metaanalysis. Cancer 2004;101:1720-32. http://www.ncbi.nlm.nih.gov/pubmed/15386341 Briel M, Studer M, Glass T, et al. Effects of statins on stroke prevention in patients with and without coronary heart disease: a meta-analysis of randomized controlled trials. Am J Med 2004;117:596-606. http://www.ncbi.nlm.nih.gov/pubmed/15465509
- Methods: Grading Strength of Evidence Authors should report any assessments they made of risk of bias that may effect the cumulative evidence. One example of such bias is study level publication bias. The example in the slide gives the level of detail that authors should report. Reference: Hróbjartsson A, Gøtzsche PC. Placebo interventions for all clinical conditions. Cochrane Database Syst Rev 2004;(1):CD003974. http://www.ncbi.nlm.nih.gov/pubmed/20091554
- Methods: Additional Analyses Additional analysis, such as a subgroup analysis or a meta-regression, should be reported in the same detail as the other methods used in the review. this slide shows an example of additional analyses conducted as part of a review. Reference: Briel M, Schwartz GG, Thompson PL, et al. Effects of early treatment with statins on short-term clinical outcomes in acute coronary syndromes: a meta-analysis of randomized controlled trials. JAMA 2006;295:2046-56. http://www.ncbi.nlm.nih.gov/pubmed/16670413
- Results Overview The next several slides describe how results should be reported, including information on the study selection, the study characteristics, and quality assessment.
- Results: Study Selection In reporting the study selection, authors should provide information on the numbers of studies screened, assessed for eligibility, and actually included in the review. Authors should also provide the rationale for the exclusion of studies at each of these stages. This can be done in two ways. In the example in this slide, authors provide the rationale in a narrative format. The authors report the starting total of 548 records (usually titles and/or abstracts) initially identified in searches of electronic databases and then describe how studies were excluded until only 5 studies remained that met the inclusion criteria for the systematic review. The other way to provide this information is to use a flow diagram, an example of which is presented on the next slide. One common mistake in reporting study selection is to put the information in the Methods section, for example, under eligibility criteria. Study selection should be the first part of the Results section. Reference: Uitterhoeve RJ, Vernooy M, Litjens M, et al. Psychosocial interventions for patients with advanced cancer — a systematic review of the literature. Br J Cancer 2004;91:1050-62. http://www.ncbi.nlm.nih.gov/pubmed/15316564
- Examples of Flow Diagrams The flow diagram is a good option to consider when reporting the steps used to select studies for the systematic review. Such diagrams can be included within the report or in the appendix. There are many different ways to design flow diagrams. This slide shows two examples. In the example labeled Figure 2, the authors have laid out the flow diagram in an easy-to-comprehend manner. Notice too that the bottom three boxes contain numerical data, a level of detail that is important to give when using flow diagrams. Reference: Sharma M, Ansari MT, Abou-Setta AM, et al. Systematic review: comparative effectiveness and harms of combination therapy and monotherapy for dyslipidemia. Ann Intern Med 2009;151:622-30. http://www.ncbi.nlm.nih.gov/pubmed/19884623 Fuccio L, Minardi ME, Zagari RM, et al. Meta-analysis: duration of first-line proton-pump inhibitor based triple therapy for Helicobacter pylori eradication. Ann Intern Med 2007;147:553-62. http://www.ncbi.nlm.nih.gov/pubmed/17938394
- Results: Study Characteristics Authors should report the characteristics of the studies that were included in the review. This can be adequately achieved within the text or by using tables and figures. The example shows how to report study characteristics in text and the level of detail required. The Presentation of Findings module offers additional guidance on how to present study characteristics. Reference: Curioni C, André C. Rimonabant for overweight or obesity. Cochrane Database Syst Rev 2006;(4):CD006162. http://www.ncbi.nlm.nih.gov/pubmed/17054276
- Results: Quality Assessment Authors should provide quality assessment information on each of the studies included in the review. In this example, the columns represent the quality criteria used, and the rows represent the individual studies included in the review. The table is populated with the quality assessment results. Refer to the Assessing the Quality of Individual Studies module for additional guidance. References: Devereaux PJ, Beattie WS, Choi PT, et al. How strong is the evidence for the use of perioperative beta blockers in non-cardiac surgery? Systematic review and meta-analysis of randomised controlled trials. BMJ 2005;331:313-21. http://www.ncbi.nlm.nih.gov/pubmed/15996966 Liberati A, Altman DF, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Ann Intern Med 2009;151:W65-94. http://www.ncbi.nlm.nih.gov/pubmed/19622512
- Results: Individual Studies When reporting the results of individual studies included in a review, authors should report all outcomes, including benefits and harms, that were assessed. For each study, authors should present simple summary data for each intervention group and some effect estimates and confidence intervals with a forest plot, assuming that a meta-analysis has been done. Ideally, authors should also report the results of individual studies in evidence tables.
- Results: Synthesis of Results There are at least three ways to present syntheses of results. It can be textual, as in the detailed example in this slide. Summary tables and evidence maps are also useful. More detailed information on the use of tables can be found in the Presentation of Findings module. Reference: Duffett M, Choong K, Ng V, Randolph A, et al. Surfactant therapy for acute respiratory failure in children: a systematic review and meta-analysis. Crit Care 2007;11:R66. http://www.ncbi.nlm.nih.gov/pubmed/17573963
- Results: Risk of Bias Across Studies There should be synergy between what authors report about their methods and what they report about their results. For example, in reporting methods, authors should also report on the risk of bias across studies (see the slide “Methods: Risk of Bias Across Studies” in this talk for additional information). The results of such as assessment need to be included in the results section as well. For example, in providing information about how the strength of a body of evidence was graded, authors should discuss risk of bias, directness, consistency, and precision. Review the Grading the Strength of Evidence module for additional guidance. Reference: Ip S, Terasawa T, Balk EM, et al. Comparative Effectiveness of Radiofrequency Catheter Ablation for Atrial Fibrillation . Comparative Effectiveness Review No. 15 (Prepared by Tufts–Mew England Medical Center Evidence-based Practice Center under Contract No. 290-02-0022). Rockville, MD: Agency for Healthcare Research and Quality, July 2009. AHRQ Publication No. 09-EHC015-EF. Available at: http://www.effectivehealthcare.ahrq.gov/ehc/products/51/114/2009_0623RadiofrequencyFinal.pdf.
- Results: Additional Sensitivity Analyses Authors should report sensitivity analyses, which is usually methodological (e.g., high quality vs. low quality; low risk of bias vs. high risk of bias), separate from subgroup analyses in the report. The example in this slide provides the type of information authors should include in reporting any additional sensitivity analyses. Reference: Reichenbach S, Sterchi R, Scherer M, et al. Meta-analysis: chondroitin for osteoarthritis of the knee or hip. Ann Intern Med 2007;146:580-90. http://www.ncbi.nlm.nih.gov/pubmed/17438317
- Results: Additional Subgroup Analyses It is important to separate subgroup analyses, which is usually clinical (e.g., men vs. women; young vs. old), from sensitivity analyses when reporting results. The example in this slide provides the type of information authors should include in reporting any additional subgroup analyses. Reference: Hodson EM, Craig JC, Strippoli GF, et al. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev 2008;(2):CD003774. http://www.ncbi.nlm.nih.gov/pubmed/18425894
- Discussion: Summary of Evidence Authors should summarize the main findings, including the strength of evidence for each of the main outcomes. Review the Assessing Applicability and Grading of Strength of Evidence modules for helpful information.
- Discussion: Summary of Evidence This slide illustrates a well-written example of a summary of evidence. Reference: Wilt TJ, Shamliyan T, Taylor B, et al. Comparative Effectiveness of Therapies for Clinically Localized Prostate Cancer . Comparative Effectiveness Review No. 13 (Prepared by Minnesota Evidence-based Practice Center under Contract No. 290-02-0009). Rockville, MD: Agency for Healthcare Research and Quality, February 2008. AHRQ Publication No. 08-EHC010-EF. Available at: http://www.effectivehealthcare.ahrq.gov/ehc/products/9/80/2008_0204ProstateCancerFinal.pdf.
- Discussion: Limitations Authors should feel comfortable reporting on the limitations of the review, because all reviews have limitations. Some of the limitations will be at the study level and some will be at the outcome level. The example illustrates the sort of information that should be included in the discussion section of the document. Reference: Liberati A, D'Amico R, Pifferi, et al. Antibiotic prophylaxis to reduce respiratory tract infections and mortality in adults receiving intensive care. Cochrane Database Syst Rev 2004;(1):CD000022. http://www.ncbi.nlm.nih.gov/pubmed/14973945
- Discussion: Conclusions Authors should provide a general interpretation of the results in the context of other evidence and the implications for future research. Reference: Sharma M, Ansari MT, Soares-Weiser K, et al. Comparative Effectiveness of Lipid-Modifying Agents . Comparative Effectiveness Review No. 16 (Prepared by the University of Ottawa Evidence-based Practice Center under contract No. 290-02-0021). Rockville, MD: Agency for Healthcare Research and Quality, September 2009. AHRQ Publication No. 09-EHC024-EF. Available at: http://www.effectivehealthcare.ahrq.gov/ehc/products/11/171/reptbodyfin-typofixed4-12-2010.pdf.
- Key Messages Reporting the findings of a systematic review is the final step in the continuum of the review process. The report should convey in a transparent manner what was done and what was found. It is especially important to be transparent in reporting the methods and the results. Doing so helps all readers—including consumers, clinicians, and policymakers—better understand the review process. Inadequate reporting makes it more difficult to judge the validity of the methods and the results, thereby making the review less useful as tool for effective health care.
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