An approach to addressing subpopulation considerations in systematic reviews: The experience of reviewers supporting the U.S. Preventive Services Task Force

Systematic Reviews

Volumn 6, Issue 1, 2017, Pages

  Whitlock, Evelyn P ^a   Eder, Michelle ^b   Thompson, Jamie H ^b   Jonas, Daniel E ^c   Evans, Corinne V ^b   Guirguis Blake, Janelle M ^d   Lin, Jennifer S ^b  

^a PATIENT CENTERED OUTCOMES RESEARCH INSTITUTE   (United States)

^b CENTER FOR HEALTH RESEARCH   (United States)

^c UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF WASHINGTON   (United States)

Author keywords

Heterogeneity; Patient subpopulation; Subgroup; Systematic review

Indexed keywords

BIBLIOGRAPHIC DATABASE; CARDIOVASCULAR DISEASE; DISEASE SEVERITY; HUMAN; MATHEMATICAL MODEL; MEDICAL SOCIETY; META ANALYSIS (TOPIC); NOTE; POSITIVE END EXPIRATORY PRESSURE; PREVENTIVE MEDICINE; PRIORITY JOURNAL; PUBLIC HEALTH; RANDOMIZED CONTROLLED TRIAL (TOPIC); SLEEP DISORDERED BREATHING; STATISTICAL MODEL; STUDY DESIGN; SYSTEMATIC REVIEW (TOPIC); UNITED STATES; ADVISORY COMMITTEE; EVIDENCE BASED MEDICINE; GOVERNMENT; INTERVIEW; LITERATURE; PRACTICE GUIDELINE; PREVENTIVE HEALTH SERVICE; PRIMARY HEALTH CARE; STANDARDS;

ADVISORY COMMITTEES; EVIDENCE-BASED MEDICINE; HUMANS; INTERVIEWS AS TOPIC; PRACTICE GUIDELINES AS TOPIC; PREVENTIVE HEALTH SERVICES; PRIMARY HEALTH CARE; REVIEW LITERATURE AS TOPIC; UNITED STATES; UNITED STATES AGENCY FOR HEALTHCARE RESEARCH AND QUALITY;

EID: 85014394517     PISSN: None     EISSN: 20464053     Source Type: Journal    
DOI: 10.1186/s13643-017-0437-3     Document Type: Note

References (69)

1. Varadhan R, Segal JB, Boyd CM, Wu AW, Weiss CO. A framework for the analysis of heterogeneity of treatment effect in patient-centered outcomes research. J Clin Epidemiol. 2013;66(8):818-25. doi: 10.1016/j.jclinepi.2013.02.009.
2. West SL, Gartlehner G, Mansfield AJ, Poole C, Tant E, Lenfestey N, et al. Comparative Effectiveness Review Methods: Clinical Heterogeneity. Rockville: Agency for Healthcare Research and Quality; 2010. AHRQ Publication No. 10-EHC070-EF.
3. Gagnier JJ, Moher D, Boon H, Beyene J, Bombardier C. Investigating clinical heterogeneity in systematic reviews: a methodologic review of guidance in the literature. BMC Med Res Methodol. 2012;12:111.
4. Chou R, Dana T, Blazina I, Daeges M, Bougatsos C, Grusing S, et al. Statins for prevention of cardiovascular disease in adults: systematic review for the U.S. Preventive Services Task Force. Rockville: Agency for Healthcare Research and Quality; 2015. AHRQ Publication No. 14-05206-EF-2.
5. Guirguis-Blake JM, Evans CV, Senger CA, Rowland MG, O'Connor EA, Whitlock EP. Aspirin for the primary prevention of cardiovascular events: a systematic evidence review for the U.S. Preventive Services Task Force. Rockville: Agency for Healthcare Research and Quality; 2015. AHRQ Publication No. 13-05195-EF-1.
6. Jonas DE, Amick HR, Feltner C, Palmieri Weber R, Arvanitis M, Stine A, et al. Screening for obstructive sleep apnea in adults: an evidence review for the U.S. Preventive Services Task Force. Rockville: Agency for Healthcare Research and Quality; 2016. AHRQ Publication No. 14-05216-EF-1.
7. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration; 2011. Available from www.handbook.cochrane.org.
8. Guyatt GH, Oxman AD, Kunz R, Woodcock J, Brozek J, Helfand M, et al. GRADE guidelines: 7. Rating the quality of evidence-inconsistency. J Clin Epidemiol. 2011;64(12):1294-302.
9. Guyatt GH, Oxman AD, Kunz R, Atkins D, Brozek J, Vist G, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol. 2011;64(4):395-400.
10. Moberg J, Alonso-Coello P, Oxman AD. GRADE Evidence to Decision (EtD) Frameworks Guidance. Version 1.1 [updated May 2015], The GRADE Working Group, 2015. Available from: https://ietd.epistemonikos.org/#/help/guidance.
11. Cochrane Child Health. Methods for child health reviews. http://childhealth.cochrane.org/methods-child-health-reviews. Accessed 24 Aug 2016.
12. Canadian Task Force on Preventive Health Care. Procedure manual. Canadian Task Force on Preventive Health Care. 2014. http://canadiantaskforce.ca/wp-content/uploads/2016/12/procedural-manual-en_2014_Archived.pdf. Accessed 11 Nov 2015.
13. National Institute for Health and Care Excellence. The Guidelines Manual. National Institute for Health and Care Excellence. 2012. http://www.nice.org.uk/article/PMG6/chapter/1%20Introduction. Accessed 11 Nov 2015.
14. IOM (Institute of Medicine). Finding what works in health care: standards for systematic reviews. Washington, DC: The National Academies Press; 2011. http://iom.nationalacademies.org/Reports/2011/Finding-What-Works-in-Health-Care-Standards-for-Systematic-Reviews.aspx. Accessed 11 Nov 2015.
15. Welch V, Petticrew M, Petkovic J, Moher D, Waters E, White H, et al. Extending the PRISMA statement to equity-focused systematic reviews (PRISMA-E 2012): explanation and elaboration. J Clin Epidemiol. 2016;70:68-89. doi: 10.1016/j.jclinepi.2015.09.001.
16. National Institute for Health and Clinical Excellence. Positively equal: a guide to addressing equality issues in developing NICE clinical guidelines. 2nd ed. 2012.
17. Bibbins-Domingo K, Whitlock E, Wolff T, Ngo-Metzger Q, Phillips WR, Davidson KW, et al. Developing recommendations for evidence-based clinical preventive services for diverse populations: methods of the U.S. Preventive Services Task Force. Annals of Internal Medicine. 2017. In press.
18. PCORI. (Patient-Centered Outcomes Research Institute) Methodology Committee. The PCORI Methodology Report. Washington DC: Patient-Centered Outcomes Research Institute; 2013.
19. Gagnier JJ, Morgenstern H, Altman DG, Berlin J, Chang S, McCulloch P, et al. Consensus-based recommendations for investigating clinical heterogeneity in systematic reviews. BMC Med Res Methodol. 2013;13:106.
20. The Grade Working Group. GRADE Guidelines-best practices using the GRADE framework. In: The GRADE Working Group. The GRADE Working Group. 2014. http://www.gradeworkinggroup.org/. Accessed 11 Nov 2015.
21. U.S. Preventive Services Task Force. U.S. Preventive Services Task Force Procedure Manual. Rockville: Agency for Healthcare Research and Quality; 2015. AHRQ Publication No. 08-05118-EF.
22. Effective Health Care Program. Methods guide for effectiveness and comparative effectiveness reviews. Rockville: Agency for Healthcare Research and Quality; 2011. AHRQ Publication No. 10(11)-EHC063-EF.
23. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001;134(8):663-94.
24. Sun X, Briel M, Busse JW, You JJ, Akl EA, Mejza F, et al. Credibility of claims of subgroup effects in randomised controlled trials: systematic review. BMJ. 2012;344:e1553.
25. Petticrew M, Tugwell P, Kristjansson E, Oliver S, Ueffing E, Welch V. Damned if you do, damned if you don't: subgroup analysis and equity. J Epidemiol Community Health. 2012;66(1):95-8. doi: 10.1136/jech.2010.121095.
26. Sun X, Ioannidis JP, Agoritsas T, Alba AC, Guyatt G. How to use a subgroup analysis: users' guide to the medical literature. JAMA. 2014;311(4):405-11. doi: 10.1001/jama.2013.285063.
27. Schmid CH, Lau J, McIntosh MW, Cappelleri JC. An empirical study of the effect of the control rate as a predictor of treatment efficacy in meta-analysis of clinical trials. Stat Med. 1998;17(17):1923-42.
28. Lau J, Terrin N, Fu R. Expanded guidance on selected quantitative synthesis topics. Methods Guide for Effectiveness and Comparative Effectiveness Reviews. Agency for Healthcare Research and Quality: Rockville,2013.
29. Fu R, Gartlehner G, Grant M, Shamliyan T, Sedrakyan A, Wilt TJ, et al. Conducting quantitative synthesis when comparing medical interventions: AHRQ and the Effective Health Care Program. J Clin Epidemiol. 2011;64(11):1187-97.
30. O'Connor EA, Lin J, Burda BU, Henderson JT, Walsh ES, Whitlock EP. Behavioral sexual risk reduction counseling in primary care to prevent sexually transmitted infections: an updated systematic evidence review for the U.S. Preventive Services Task Force. Rockville: Agency for Healthcare Research and Quality; 2014. AHRQ Publication No. 13-05180-EF-1.
31. Cornell JE, Mulrow CD, Localio R, Stack CB, Meibohm AR, Guallar E, et al. Random-effects meta-analysis of inconsistent effects: a time for change. Ann Intern Med. 2014;160(4):267-70.
32. Cochran WG. The combination of estimates from different experiments. Biometrics. 1954;10(1):101-29.
33. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21(11):1539-58.
34. Velentgas P, Dreyer NA, Nourjah P, Smith SR, Torchia MM. Developing a protocol for observational comparative effectiveness research: a user's guide. Rockville: Agency for Healthcare Research and Quality; 2013. AHRQ Publication No.12(13)-EHC099.
35. Gartlehner G, West SL, Mansfield AJ, Poole C, Tant E, Lux LJ, et al. Clinical heterogeneity in systematic reviews and health technology assessments: synthesis of guidance documents and the literature. Int J Technol Assess Health Care. 2012;28(1):36-43.
36. Baujat B, Mahe C, Pignon JP, Hill C. A graphical method for exploring heterogeneity in meta-analyses: application to a meta-analysis of 65 trials. Stat Med. 2002;21(18):2641-52. doi: 10.1002/sim.1221.
37. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009;151(4):264-9. W64.
38. Berkman ND, Lohr KN, Ansari M, McDonagh M, Balk E, Whitlock EP, et al. Grading the strength of a body of evidence when assessing health care interventions for the effective health care program of the agency for healthcare research and quality: an update. Rockville: Agency for Healthcare Research and Quality; 2013. AHRQ Publication No. 13(14)-EHC130-EF.
39. U.S. Preventive Services Task Force. Final research plan: obstructive sleep apnea in adults: screening. 2014. http://www.uspreventiveservicestaskforce.org/Page/Document/final-research-plan142/obstructive-sleep-apnea-in-adults-screening. Accessed November 11, 2015.
40. Scott IA, Guyatt GH. Cautionary tales in the interpretation of clinical studies involving older persons. Arch Intern Med. 2010;170(7):587-95.
41. Yusuf S, Wittes J, Probstfield J, Tyroler HA. Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. Jama. 1991;266(1):93-8.
42. American Academy of Family Physicians. Developing clinical practice guidelines. American Academy of Family Physicians, Leawood, KS. http://www.aafp.org/patient-care/clinical-recommendations/practice-guidelines.html. Accessed 11 Nov 2015.
43. American Academy of Pediatrics. Clinical practice guidelines and policy implementation. American Academy of Pediatrics, Elk Grove Village, IL. https://www.aap.org/en-us/professional-resources/quality-improvement/Pages/Guidelines-and-Policy-Development.aspx. Accessed 11 Nov 2015.
44. American Congress of Obstetricians and Gynecologists. Resources & publications. American Congress of Obstetricians and Gynecologists, Washington DC. http://www.acog.org/Resources_And_Publications. Accessed 11 Nov 2015.
45. American College of Physicians. Guideline process: how does ACP develop clinical recommendations American College of Physicians,. http://www.acponline.org/clinical_information/guidelines/guidelines/process.htm. Accessed 11 Nov 2015.
46. Qaseem A, Snow V, Owens DK, Shekelle P. The development of clinical practice guidelines and guidance statements of the American College of Physicians: summary of methods. Ann Intern Med. 2010;153(3):194-9.
47. Community Preventive Services Task Force. Systematic review methods. Community Preventive Services Task Force,. http://www.thecommunityguide.org/about/methods.html. Accessed 11 Nov 2015.
48. Briss PA, Zaza S, Pappaioanou M, Fielding J, Wright-De AL, Truman BI, et al. Developing an evidence-based guide to community preventive services-methods. The Task Force on Community Preventive Services. Am J Prev Med. 2000;18(1 Suppl):35-43.
49. The Cochrane Collaboration. Cochrane reviews. The Cochrane Collaboration,. http://www.cochrane.org/what-is-cochrane-evidence. Accessed 11 Nov 2015.
50. IOM (Institute of Medicine). Clinical practice guidelines we can trust. The National Academies Press, Washington, DC. 2011. http://iom.nationalacademies.org/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust.aspx. Accessed 11 Nov 2015.
51. Glasziou PP, Sanders SL. Investigating causes of heterogeneity in systematic reviews. Stat Med. 2002;21(11):1503-11.
52. Guyatt G, Oxman AD, Akl EA, Kunz R, Vist G, Brozek J, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol. 2011;64(4):383-94.
53. Fernandez YG, Nguyen H, Duan N, Gabler NB, Kravitz RL. Assessing heterogeneity of treatment effects: are authors misinterpreting their results Health Serv Res. 2010;45(1):283-301.
54. Rothwell PM. Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation. Lancet. 2005;365(9454):176-86.
55. Lagakos SW. The challenge of subgroup analyses-reporting without distorting. N Engl J Med. 2006;354(16):1667-9. doi: 10.1056/NEJMp068070.
56. VanderWeele TJ, Knol MJ. Interpretation of subgroup analyses in randomized trials: heterogeneity versus secondary interventions. Ann Intern Med. 2011;154(10):680-3.
57. Sun X, Briel M, Walter SD, Guyatt GH. Is a subgroup effect believable Updating criteria to evaluate the credibility of subgroup analyses. BMJ. 2010;340:c117.
58. Guyatt GH, Oxman AD, Kunz R, Brozek J, Alonso-Coello P, Rind D, et al. GRADE guidelines: 6. Rating the quality of evidence-imprecision. J Clin Epidemiol. 2011;64(12):1283-93.
59. Kent DM, Rothwell PM, Ioannidis JP, Altman DG, Hayward RA. Assessing and reporting heterogeneity in treatment effects in clinical trials: a proposal. Trials. 2010;11:85.
60. Rothwell PM, Mehta Z, Howard SC, Gutnikov SA, Warlow CP. Treating individuals 3: from subgroups to individuals: general principles and the example of carotid endarterectomy. Lancet. 2005;365(9455):256-65.
61. Egger M, Smith GD, Altman DG. Systematic reviews in health care: meta-analysis in context. London: BMJ Publishing Group; 2001.
62. Glasziou PP, Irwig LM. An evidence based approach to individualising treatment. BMJ. 1995;311(7016):1356-9.
63. Ridker PM, Cook NR, Lee IM, Gordon D, Gaziano JM, Manson JE, et al. A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women. N Engl J Med. 2005;352(13):1293-304. doi: 10.1056/NEJMoa050613.
64. Thompson SG, Higgins JP. Treating individuals 4: can meta-analysis help target interventions at individuals most likely to benefit Lancet. 2005;365(9456):341-6.
65. McAlister FA, Straus SE, Guyatt GH, Haynes RB. Users' guides to the medical literature: XX. Integrating research evidence with the care of the individual patient. Evidence-Based Medicine Working Group. JAMA. 2000;283(21):2829-36.
66. Atkins D, Chang SM, Gartlehner G, Buckley DI, Whitlock EP, Berliner E, et al. Assessing applicability when comparing medical interventions: AHRQ and the Effective Health Care Program. J Clin Epidemiol. 2011;64(11):1198-207.
67. Arias E. United States life tables, 2007. Natl Vital Stat Rep. 2011;59(9):1-60.
68. Gabler NB, Duan N, Liao D, Elmore JG, Ganiats TG, Kravitz RL. Dealing with heterogeneity of treatment effects: is the literature up to the challenge Trials. 2009;10:43.
69. The White House. The precision medicine initiative. Washington, DC. 2015. https://www.whitehouse.gov/precision-medicine. Accessed 11 Nov 2015.