Review of quality assessment tools for the evaluation of pharmacoepidemiological safety studies

BMJ Open

Volumn 2, Issue 5, 2012, Pages

  Neyarapally, George A ^a   Hammad, Tarek A ^a   Pinheiro, Simone P ^a   Iyasu, Solomon ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL ASSESSMENT TOOL; CLINICAL EVALUATION; DRUG SAFETY; ELECTRONIC MEDICAL RECORD; FOOD AND DRUG ADMINISTRATION; HUMAN; MEDICAL LITERATURE; MEDICAL RESEARCH; OUTCOME ASSESSMENT; PHARMACOEPIDEMIOLOGY; POSTMARKETING SURVEILLANCE; QUALITY ASSESSMENT ATTRIBUTE; QUALITY CONTROL; REVIEW;

EID: 84869828902     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2012-001362     Document Type: Review

References (100)

1. Hammad TA, Pinheiro SP, Neyarapally GA. Secondary use of randomized controlled trials to evaluate drug safety: a review of methodological considerations. Clin Trials 2011;8:559-70.
2. Ioannidis JP. Adverse events in randomized trials: neglected, restricted, distorted, and silenced. Arch Intern Med 2009;169:1737-9.
3. Pitrou I, Boutron I, Ahmad N, et al. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med 2009;169:1756-61.
4. Clark DW, Coulter DM, Besag FM. Randomized controlled trials and assessment of drug safety. Drug Saf 2008;31:1057-61.
5. American Recovery and Reinvestment Act. Pub.L. 2009;111-5
6. Bruen BK, Ku L, Burke MF, et al. More than four in five office-based physicians could qualify for federal electronic health record incentives. Health Aff (Millwood) 2011;30:472-80.
7. Schneeweiss S, Avorn J. A review of uses of health care utilization databases for epidemiologic research on therapeutics. J Clin Epidemiol 2005;58:323-37.
8. Dreyer N, Tunis S, Berger M. Why observational studies should be among the tools used in comparative effectiveness research. Health Affairs 2010;29:1818.
9. Dreyer N. Do we need good practice principles for observational comparative effectiveness research? GRACE Initiative (serial online) 2009. http://www.graceprinciples.org/art/GRACE-principles-25-october-2009.pdf (accessed on 3 Mar 2011).
10. Tunis SR, Benner J, McClellan M. Comparative effectiveness research: policy context, methods development and research infrastructure. Stat Med 2010;29:1963-76.
11. Institute of Medicine. Ethical and Scientific Issues in Studying the Safety of Approved Drugs. 2012.
12. von EE, Altman DG, Egger M, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol 2008;61:344-9.
13. FDA. FDA Draft Guidance: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets. FDA Draft Guidance. 2011.
14. Atkins D, Best D, Briss PA, et al. Grading quality of evidence and strength of recommendations. BMJ 2004;328:1490.
15. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336:924-6.
16. Deeks JJ, Dinnes J, D'Amico R, et al. Evaluating non-randomised intervention studies. Health Technol Assess 2003;7:173.
17. Sanderson S, Tatt ID, Higgins JP. Tools for assessing quality and susceptibility to bias in observational studies in epidemiology: a systematic review and annotated bibliography. Int J Epidemiol 2007;36:666-76.
18. Lohr KN. Rating the strength of scientific evidence: relevance for quality improvement programs. Int J Qual Health Care 2004;16:9-18.
19. Cornelius VR, Perrio MJ, Shakir SA, et al. Systematic reviews of adverse effects of drug interventions: a survey of their conduct and reporting quality. Pharmacoepidemiol Drug Saf 2009;18:1223-31.
20. Chou R, Helfand M. Challenges in systematic reviews that assess treatment harms. Ann Intern Med 2005;142:1090-9.
21. Loke YK, Price D, Herxheimer A. Systematic reviews of adverse effects: framework for a structured approach. BMC Med Res Methodol 2007;7:32.
22. Mallen C, Peat G, Croft P. Quality assessment of observational studies is not commonplace in systematic reviews. J Clin Epidemiol 2006;59:765-9.
23. da Costa BR, Cevallos M, Altman DG, et al. Uses and misuses of STROBE statement: bibliographic study. BMJ Open 2011; 1:e000048 doi:10.1136/bmjopen- 2010-000048.
24. EMA. Checklist for Methodological Standards for ENCePP Study Protocols. 2010.
25. Sanderson S, Tatt ID, Higgins JP. Tools for assessing the quality and susceptibility to bias in observational studies in epidemiology: a systematic review and annotated bibliography. Int J Epidemiol 2007;36:666.
26. Deeks JJ, Dinnes J, D'Amico R. Evaluating non-randomised intervention studies. Health Technol Assess 2003;7:iii-x, 1-173.
27. Lohr K. Rating the strength of scientific evidence: relevance for quality improvement programs. Int J Qual Health Care 2004;16:9-18.
28. von Elm E. STROBE. J Clin Epidemiol 2008;61:344-9.
29. Balshem H, Helfand M, Schunemann HJ,, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol 2011;64:401-6.
30. Downs SH, Black N. The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions. J Epidemiol Community Health 1998;52:377-84.
31. Macfarlane TV, Glenny AM, Worthington HV. Systematic review of population-based epidemiological studies of oro-facial pain. J Dent 2001;29:451-67.
32. Margetts BM, Thompson RL, Key T,, et al. Development of a scoring system to judge the scientific quality of information from case-control and cohort studies of nutrition and disease. Nutr Cancer 1995;24:231-9.
33. Rangel SJ, Kelsey J, Colby CE, et al. Development of a quality assessment scale for retrospective clinical studies in pediatric surgery. J Pediatr Surg 2003;38:390-6.
34. Genaidy AM, Lemasters GK, Lockey J,, et al. An epidemiological appraisal instrument-a tool for evaluation of epidemiological studies. Ergonomics 2007;50:920-60.
35. Santaguida P, Raina P. McMaster Quality Assessment Scale of Harms (McHarm) for primary studies. 2008 http://hiru.mcmaster.ca/epc/mcharm.pdf (accessed on 27 Oct 2010).
36. Cho MK, Bero LA. Instruments for assessing the quality of drug studies published in the medical literature. JAMA 1994;272:101-4.
37. Avis M. Reading research critically. II. An introduction to appraisal: assessing the evidence. J Clin Nurs 1994;3:271-7.
38. Cameron I, Crotty M, Currie C,, et al. Geriatric rehabilitation following fractures in older people: a systematic review. Health Technol Assess 2000;4:111.
39. Carneiro AV. Critical appraisal of prognostic evidence: practical rules. Rev Port Cardiol 2002;21:891-900.
40. NHS. Critical appraisal skills programme: appraisal tools. Public Health Resource Unit N, editor. 2003.
41. Center for Occupational and Environmental Health. Critical appraisal. School of Epidemiology and Health Sciences UoM, editor. 2003.
42. DuRant RH. Checklist for the evaluation of research articles. J Adolesc Health 1994;15:4-8.
43. Elwood M. Forward projection-using critical appraisal in the design of studies. Int J Epidemiol 2002;31:1071-3.
44. Esdaile JM, Horwitz RI. Observational studies of cause-effect relationships: an analysis of methodologic problems as illustrated by the conflicting data for the role of oral contraceptives in the etiology of rheumatoid arthritis. J Chronic Dis 1986;39:841-52.
45. Gardner MJ, Machin D, Campbell MJ. Use of check lists in assessing the statistical content of medical studies. Br Med J (Clin Res Ed) 1986;292:810-2.
46. Health Evidence Bulletin. Questions to assist with the critical appraisal of an observational study eg cohort, case-control, cross-sectional. Wales, editor. 2004.
47. Levine M, Walter S, Lee H, et al. Users' guides to the medical literature. IV. How to use an article about harm. Evidence-Based Medicine Working Group. JAMA 1994;271:1615-19.
48. Lichtenstein MJ, Mulrow CD, Elwood PC. Guidelines for reading case-control studies. J Chronic Dis 1987;40:893-903.
49. Federal Focus I. The London principles for evaluating epidemiologic data in regulatory risk assessment. Fed Focus (serial online) 2004 http://www.fedfocus.org/science/londonprinciples.html (accessed on 5 Nov 2010).
50. Margetts BM, Vorster V. Evidence-based nutrition - review of nutritional epidemiological studies. South Afr J Clin Nutr 2002;15:68-73.
51. University of Montreal. Critical Appraisal Worksheet. 2004.
52. Mulrow CD, Lichtenstein MJ. Blood glucose and diabetic retinopathy: a critical appraisal of new evidence. J Gen Intern Med 1986;1:73-7.
53. Whiting P, Rutjes AW, Reitsma JB, et al. The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med Res Methodol 2003;3:25.
54. Scottish Intercollegiate Guidelines Network. SIGN 50: A guideline developer's handbook. Scottish Intercollegiate Guidelines Network (serial online) 2004.
55. Parker S. Critical appraisal: Guidelines for the critical appraisal of a paper. Website (serial online) 2004.
56. Zaza S, Wright-De Aguero LK, Briss PA, et al. Data collection instrument and procedure for systematic reviews in the Guide to Community Preventive Services. Task Force on Community Preventive Services. Am J Prev Med 2000;18:44-74.
57. Zola P, Volpe T, Castelli G, et al. Is the published literature a reliable guide for deciding between alternative treatments for patients with early cervical cancer? Int J Radiat Oncol Biol Phys 1989;16:785-97.
58. Ariens GA, van MW, Bongers PM, et al. Physical risk factors for neck pain. Scand J Work Environ Health 2000;26:7-19.
59. Bhutta AT, Cleves MA, Casey PH, et al. Cognitive and behavioral outcomes of school-aged children who were born preterm: a meta-analysis. JAMA 2002;288:728-37.
60. Borghouts JA, Koes BW, Bouter LM. The clinical course and prognostic factors of non-specific neck pain: a systematic review. Pain 1998;77:1-13.
61. Carson CA, Fine MJ, Smith MA, et al. Quality of published reports of the prognosis of community-acquired pneumonia. J Gen Intern Med 1994;9:13-19.
62. Loney PL, Chambers LW, Bennett KJ, et al. Critical appraisal of the health research literature: prevalence or incidence of a health problem. Chronic Dis Can 1998;19:170-6.
63. Corrao G, Bagnardi V, Zambon A, et al. Exploring the dose - response relationship between alcohol consumption and the risk of several alcohol-related conditions: a meta-analysis. Addiction 1999;94:1551-73.
64. Garber BG, Hebert PC, Yelle JD, et al. Adult respiratory distress syndrome: a systemic overview of incidence and risk factors. Crit Care Med 1996;24:687-95.
65. Goodman SN, Berlin J, Fletcher SW, et al. Manuscript quality before and after peer review and editing at Annals of Internal Medicine. Ann Intern Med 1994;121:11-21.
66. Jabbour M, Osmond MH, Klassen TP. Life support courses: are they effective? Ann Emerg Med 1996;28:690-8.
67. Kreulen CM, Creugers NH, Meijering AC. Meta-analysis of anterior veneer restorations in clinical studies. J Dent 1998;26:345-53.
68. Krogh CL. A checklist system for critical review of medical literature. Med Educ 1985;19:392-5.
69. Littenberg B, Weinstein LP, McCarren M, et al. Closed fractures of the tibial shaft. A meta-analysis of three methods of treatment. J Bone Joint Surg Am 1998;80:174-83.
70. Longnecker MP, Berlin JA, Orza MJ, et al. A meta-analysis of alcohol consumption in relation to risk of breast cancer. JAMA 1988;260:652-6.
71. Manchikanti L, Singh V, Vilims BD, et al. Medial branch neurotomy in management of chronic spinal pain: systematic review of the evidence. Pain Phys 2002;5:405-18.
72. Meijer R, Ihnenfeldt DS, van LJ, et al. Prognostic factors in the subacute phase after stroke for the future residence after six months to one year. A systematic review of the literature. Clin Rehabil 2003;17:512-20.
73. Nguyen QV, Bezemer PD, Habets L, et al. A systematic review of the relationship between overjet size and traumatic dental injuries. Eur J Orthod 1999;21:503-15.
74. Reisch JS, Tyson JE, Mize SG. Aid to the evaluation of therapeutic studies. Pediatrics 1989;84:815-27.
75. Stock SR. Workplace ergonomic factors and the development of musculoskeletal disorders of the neck and upper limbs: a meta-analysis. Am J Ind Med 1991;19:87-107.
76. van der Windt DA, Thomas E, Pope DP, et al. Occupational risk factors for shoulder pain: a systematic review. Occup Environ Med 2000;57:433-42.
77. Bollini P, Garcia Rodriguez LA, Perez GS, et al. The impact of research quality and study design on epidemiologic estimates of the effect of nonsteroidal anti-inflammatory drugs on upper gastrointestinal tract disease. Arch Intern Med 1992;152:1289-95.
78. Ciliska D, Hayward S, Thomas H, et al. A systematic overview of the effectiveness of home visiting as a delivery strategy for public health nursing interventions. Can J Public Health 1996;87:193-8.
79. Cowley DE. Prostheses for primary total hip replacement. A critical appraisal of the literature. Int J Technol Assess Health Care 1995;11:770-8.
80. Effective Public Health Practice Project. Quality Assessment Tools for Quantitative Studies. 2003.
81. School of Population Health. EPIQ (Effective Practice, Informatics, and Quality Improvement). Faculty of Medical and Health Sciences. University of Auckland, 2004.
82. Fowkes FG, Fulton PM. Critical appraisal of published research: introductory guidelines. BMJ 1991;302:1136-40.
83. Gyorkos TW, Tannenbaum TN, Abrahamowicz M, et al. An approach to the development of practice guidelines for community health interventions. Can J Public Health 1994;85(Suppl 1):S8-13..
84. Spitzer WO, Lawrence V, Dales R,, et al. Links between passive smoking and disease: a best-evidence synthesis. A report of the Working Group on Passive Smoking. Clin Invest Med 1990;13:17-42.
85. Steinberg EP, Eknoyan G, Levin NW, et al. Methods used to evaluate the quality of evidence underlying the National Kidney Foundation-Dialysis Outcomes Quality Initiative Clinical Practice Guidelines: description, findings, and implications. Am J Kidney Dis 2000;36:1-11.
86. El BN, Middel B, van Dijk JP, et al. Are the outcomes of clinical pathways evidence-based? A critical appraisal of clinical pathway evaluation research. J Eval Clin Pract 2007;13:920-9.
87. Salford University. Evaluation tool for quantitative research studies. 2001.
88. Chou R, Aronson N, Atkins D, et al. AHRQ series paper 4: assessing harms when comparing medical interventions: AHRQ and the effective health-care program. J Clin Epidemiol 2010;63:502-12.
89. Chokshi DA, Avorn J, Kesselheim AS. Designing comparative effectiveness research on prescription drugs: lessons from the clinical trial literature. Health Aff (Millwood) 2010;29:1842-8.
90. Psaty BM, Weiss NS. NSAID trials and the choice of comparators-questions of public health importance. N Engl J Med 2007;356:328-30.
91. Strom B. Pharmacoepidemiology. 4th edn. Hoboken, New Jersey: John Wiley & Sons Ltd, 2005.
92. Brookhart MA, Sturmer T, Glynn RJ, et al. Confounding control in healthcare database research: challenges and potential approaches. Med Care 2010;48:S114-20.
93. Stang A. Critical evaluation of the Newcastle-Ottawa scale for the assessment of the quality of nonrandomized studies in meta-analyses. Eur J Epidemiol 2010;25:603-5.
94. Conway PH, Clancy C. Charting a path from comparative effectiveness funding to improved patient-centered health care. JAMA 2010;303:985-6.
95. GRACE. GRACE Checklist. 2012.
96. Hall GC, Sauer B, Bourke A, et al. Guidelines for good database selection and use in pharmacoepidemiology research. Pharmacoepidemiol Drug Saf 2012;21:1-10.
97. Hamburg MA. Shattuck lecture. Innovation, regulation, and the FDA. N Engl J Med 2010;363:2228-32.
98. Miettinen OS, Caro JJ. Principles of nonexperimental assessment of excess risk, with special reference to adverse drug reactions. J Clin Epidemiol 1989;42:325-31.
99. Guess HA. Behavior of the exposure odds ratio in a case-control study when the hazard function is not constant over time. J Clin Epidemiol 1989;42:1179-84.
100. Schneeweiss S. A basic study design for expedited safety signal evaluation based on electronic healthcare data. Pharmacoepidemiol Drug Saf 2010;19:858-68.