A questionnaire to assess the relevance and credibility of observational studies to inform health care decision making: An ISPOR-AMCP-NPC good practice task force report

Value in Health

Volumn 17, Issue 2, 2014, Pages 143-156

  Berger, Marc L ^a   Martin, Bradley C ^b   Husereau, Don ^c,d,e   Worley, Karen ^f   Allen, J Daniel ^g   Yang, Winnie ^h   Quon, Nicole C ⁱ   Mullins, C Daniel ^j   Kahler, Kristijan H ^k   Crown, William ^l  

^a PFIZER INC   (United States)

^b Division of Pharmaceutical Evaluation and Policy   (United States)

^c INSTITUTE OF HEALTH ECONOMICS   (Canada)

^d UNIVERSITY OF OTTAWA   (Canada)

^e UNIVERSITY FOR HEALTH SCIENCES   (Austria)

^f HUMANA INC   (United States)

^g OmedaRx   (United States)

^h Blue Cross of California   (United States)

ⁱ Optimer Pharmaceuticals   (United States)

^j UNIVERSITY OF MARYLAND SCHOOL OF PHARMACY   (United States)

^k NOVARTIS PHARMA AG   (Switzerland)

^l OPTUM   (United States)

more..

Author keywords

bias; checklist; comparative effectiveness research; confounding; consensus; credibility; decision making; prospective observational study; quality; questionnaire; relevance; retrospective observational study; validity

Indexed keywords

ARTICLE; CHECKLIST; CLINICAL PROTOCOL; COMPARATIVE EFFECTIVENESS; CONFLICT OF INTEREST; CONFOUNDING VARIABLE; CONSENSUS; CONSENSUS DEVELOPMENT; DATA ANALYSIS; FOLLOW UP; GOOD CLINICAL PRACTICE; HUMAN; INTERNAL VALIDITY; MEASUREMENT ERROR; MEDICAL DECISION MAKING; OBSERVATIONAL STUDY; OBSERVATIONAL STUDY ASSESSMENT QUESTIONNAIRE; OUTCOME ASSESSMENT; POPULATION; PRIORITY JOURNAL; PROSPECTIVE STUDY; PROTOCOL COMPLIANCE; QUESTIONNAIRE; SAMPLE SIZE; SCORING SYSTEM; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE; STUDY DESIGN; THERAPY EFFECT;

BIAS; CHECKLIST; COMPARATIVE EFFECTIVENESS RESEARCH; CONFOUNDING; CONSENSUS; CREDIBILITY; DECISION MAKING; PROSPECTIVE OBSERVATIONAL STUDY; QUALITY; QUESTIONNAIRE; RELEVANCE; RETROSPECTIVE OBSERVATIONAL STUDY; VALIDITY;

ADVISORY COMMITTEES; DECISION MAKING; DELIVERY OF HEALTH CARE; EVIDENCE-BASED MEDICINE; HUMANS; INTERNATIONALITY; OBSERVATIONAL STUDY AS TOPIC; QUESTIONNAIRES; RESEARCH DESIGN;

EID: 84896367143     PISSN: 10983015     EISSN: 15244733     Source Type: Journal    
DOI: 10.1016/j.jval.2013.12.011     Document Type: Article

References (48)

1. J. Jansen, T.A. Trikalinos, and J.P. Cappelleri et al. Indirect treatment comparison/network meta-analysis study questionnaire to assess study relevance and credibility to inform healthcare decision-making: an ISPOR-AMCP-NPC Good Practice Task Force report Value Health 17 2014 157 173
2. J.J. Caro, D.M Eddy, and H. Kan et al. A modeling study questionnaire to assess study relevance and credibility to inform health care decision making: an ISPOR-AMCP-NPC Good Practice Task Force report Value Health 17 2014 174 182
3. L.P. Garrison Jr, P.J. Neumann, and P. Erickson et al. Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force report Value Health 10 2007 326 335 (Pubitemid 47481104)
4. D.I. Brixner, A.P. Holtorf, and P.J. Neumann et al. Standardizing quality assessment of observational studies for decision making in health care J Manag Care Pharm 15 3 2009 275 283
5. H. Balshem, M. Helfand, and H.J. Schunemann et al. GRADE guidelines, 3: rating the quality of evidence J Clin Epidemiol 64 2011 401 406
6. D. Atkins, M. Eccles, and S. Flottorp et al. Systems for grading the quality of evidence and the strength of recommendations, I: critical appraisal of existing approaches The GRADE Working Group. BMC Health Serv Res 4 1 2004 38
7. P. Glasziou, J.P. Vandenbroucke, and I. Chalmers Assessing the quality of research BMJ 328 2004 39 41 (Pubitemid 38067746)
8. G.H. Guyatt, A.D. Oxman, and G.E. Vist et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations BMJ 336 2008 924 926 (Pubitemid 351632017)
9. D. Moher, A.R. Jadad, and P. Tugwell Assessing the quality of randomized controlled trials: current issues and future directions Int J Technol Assess Health Care 12 1996 195 208 (Pubitemid 26195520)
10. M.L. Berger, N. Dreyer, and F. Anderson et al. Prospective observational studies to assess comparative effectiveness: the ISPOR Good Research Practices Task Force report Value Health 15 2012 217 230
11. M.L. Berger, M. Mamdani, D. Atkins, and M.L. Johnson Good research practices for comparative effectiveness research: defining, reporting and interpreting nonrandomized studies of treatment effects using secondary data sources: the ISPOR Good Research Practices for Retrospective Database Analysis Task Force Report - part I Value Health 12 2009 1044 1052
12. E. Cox, B.C. Martin, and T. Van Staa et al. Good research practices for comparative effectiveness research: approaches to mitigate bias and confounding in the design of nonrandomized studies of treatment effects using secondary data sources: the International Society for Pharmacoeconomics and Outcomes Research Good Research Practices for Retrospective Database Analysis Task Force Report-part II Value Health 12 2009 1053 1061
13. M.L. Johnson, W. Crown, and B.C. Martin et al. Good research practices for comparative effectiveness research: analytic methods to improve causal inference from nonrandomized studies of treatment effects using secondary data sources: the ISPOR Good Research Practices for Retrospective Database Analysis Task Force Report - part III Value Health 12 2009 1062 1073
14. P. Juni, A. Witschi, R. Bloch, and M. Egger The hazards of scoring the quality of clinical trials for meta-analysis JAMA 282 1999 1054 1060 (Pubitemid 29436453)
15. GRACE Initiative. GRACE principles. Available from: http://www. graceprinciples.org. [Accessed December 4, 2013].
16. STROBE checklist. 2013. Available from: http://www.strobe-statement.org/ fileadmin/Strobe/uploads/checklists/STROBE-checklist-v4-cohort.pdfstatement.org/ fileadmin/Strobe/uploads/checklists/STROBE-checklist-v4-cohort.pdf. [Accessed December 4, 2013].
17. The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. Guide on methodological standards in pharmacoepidemiology (Revision 1). 2012. Available from: http://www.encepp.eu/standards-and- guidances/documents/ENCePPGuideofMethStandardsinPE.pdf. [Accessed December 4, 2013].
18. Agency for Healthcare Research and Quality. AHRQ user guide for developing a protocol for observation comparative effectiveness research. 2013. Available from: http://www.ncbi.nlm.nih.gov/books/NBK126190/. [Accessed December 4, 2013].
19. J. Slutsky, D. Atkins, and S. Chang AHRQ series paper 1: comparing medical interventions: AHRQ and the effective health-care program J Clin Epidemiol 63 2010 481 483
20. M. Helfand, and H. Balshem AHRQ series paper 2: principles for developing guidance: AHRQ and the effective health-care program J Clin Epidemiol 63 2010 484 490
21. R. Chou, N. Aronson, and D. Atkins et al. AHRQ series paper 4: assessing harms when comparing medical interventions: AHRQ and the effective health-care program J Clin Epidemiol 63 2010 502 512
22. D.K. Owens, K.N. Lohr, and D. Atkins et al. AHRQ series paper 5: grading the strength of a body of evidence when comparing medical interventions - Agency for Healthcare Research and Quality and the effective health-care program J Clin Epidemiol 63 2010 513 523
23. S.J. Rangel, J. Kelsey, and C.E. Colby et al. Development of a quality assessment scale for retrospective clinical studies in pediatric surgery J Ped Surg 38 2003 390 396 discussion 390-6 (Pubitemid 36278699)
24. D.F. Stroup, J.A. Berlin, and S.C. Morton et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group JAMA 283 2000 2008 2012 (Pubitemid 30214957)
25. K.A. Fairman, and F.R. Curtiss Rethinking the "whodunit" approach to assessing the quality of health care research - a call to focus on the evidence in evidence-based practice J Manag Care Pharm 14 7 2008 661 674
26. B. Motheral, J. Brooks, and M.A. Clark et al. A checklist for retrospective database studies - report of the ISPOR Task Force on Retrospective Databases Value Health 6 2003 90 97 (Pubitemid 36403125)
27. L. Tooth, R. Ware, and C. Bain et al. Quality of reporting of observational longitudinal research Am J Epidemiol 161 2005 280 288 (Pubitemid 40223516)
28. D. Atkins, D. Best, and P.A. Briss et al. Grading quality of evidence and strength of recommendations BMJ 328 2004 1490
29. K. Theobald, M. Capan, and M. Herbold et al. Quality assurance in non-interventional studies Ger Med Sci 2009 7 Doc 29
30. J.P. Vandenbroucke, E. von Elm, and D.G. Altman et al. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration Ann Intern Med 147 2007 W163 W194
31. S. Chavers, D. Fife, and M. Wacholtz et al. Registration of observational studies: perspectives from an industry-based epidemiology group Pharmacoepidemiol Drug Saf 20 2011 1009 1013
32. N.A. Dreyer Making observational studies count: shaping the future of comparative effectiveness research Epidemiology 22 3 2011 295 297
33. N.A. Dreyer, S.R. Tunis, and M. Berger et al. Why observational studies should be among the tools used in comparative effectiveness research Health Aff (Millwood) 29 10 2010 1818 1825
34. National Academy of Sciences. Initial national priorities for comparative effectiveness research. Available from: http://www.iom.edu/~/media/Files/ Report%20Files/2009/ComparativeEffectivenessResearchPriorities/ CER%20report%20brief%2008-13-09.ashx. [Accessed December 4, 2013].
35. A.A. Papathanasiou, and E. Zintzaras Assessing the quality of reporting of observational studies in cancer Ann Epidemiol 20 2010 67 73
36. Sackett D, Strauss S, Richardson W, et al. Evidence-Based Medicine: How to Practice and Teach EBM. London, UK: Churchill Livingstone, 2000.
37. PCORI methodology standards. Available from: http://www.pcori.org/assets/ PCORI-Methodology-Standards.pdf. [Accessed December 4, 2013].
38. G.D. Smith, and S. Ebrahim Data dredging, bias, or confounding BMJ 325 2002 1437 1438 (Pubitemid 36026785)
39. L.E. Levesque, J.A. Hanley, A. Kezouh, and S. Suissa Problem of immortal time bias in cohort studies: example using statins for preventing progression of diabetes BMJ 2010 340
40. J.H. Ellenberg Selection bias in observational and experimental studies Stat Med 13 1994 557 567 (Pubitemid 24106737)
41. A. Linden, J.L. Adams, and N. Roberts Evaluating disease management programme effectiveness: an introduction to the regression discontinuity design J Eval Clin Prac 12 2006 124 131 (Pubitemid 43384608)
42. P.C. Austin, M.M. Mamdani, D.N. Juurlink, and J.E. Hux Testing multiple statistical hypotheses resulted in spurious associations: a study of astrological signs and health J Clin Epidemiol 59 2006 964 969 (Pubitemid 44183881)
43. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: manuscript preparation and submission: preparing a manuscript for submission to a biomedical journal. Available from: http://www.icmje.org/manuscript-1prepare.html. [Accessed December 4, 2013].
44. K. Dwan, C. Gamble, and P.R. Williamson et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias - an updated review PloS One 8 2013 e66844
45. L. Forrow, W.C. Taylor, and R.M. Arnold Absolutely relative: how research results are summarized can affect treatment decisions Am J Med 92 1992 121 124
46. P.C. Gotzsche Readers as research detectives Trials 10 2009 2
47. J.P. Jansen, R. Fleurence, and B. Devine et al. Interpreting indirect treatment comparisons and network meta-analysis for health-care decision making: report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: part 1 Value Health 14 2011 417 428
48. J.J. Caro, A.H. Briggs, and U. Siebert et al. Modeling good research practices-overview: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force-1 Value Health 15 2012 796 803