Patient-important Outcomes in Systematic Reviews: Poor Quality of Evidence

Overview

Journal PLoS One

Specialties General Medicine
Science

Date 2018 Apr 6

PMID 29621329

Citations 7

Authors

Youri Yordanov

Agnes Dechartres

Philippe Ravaud

Affiliations

Soon will be listed here.

Abstract

Background: Cochrane reviewers are strongly encouraged to evaluate the quality of evidence for the most important outcomes by using the GRADE approach and to report these results in a Summary of Findings (SoF) table. We aimed to assess whether outcomes reported in the SoF table of Cochrane reviews could be considered patient-important outcomes (PIOs) and the quality of the available evidence for these outcomes.

Methods: We performed a methodological review of Cochrane reviews published between March 2011 and September 2014. For a random sample of Cochrane reviews reporting a SoF table, we extracted all outcomes reported in this table and evaluated whether they could be considered PIOs (i.e., mortality, other clinical events, adverse events, function, pain, quality of life and therapeutic decisions). Then, we collected the quality of evidence for every outcome in these SoF tables.

Results: We included 290 reviews issued by 47 of the 53 Cochrane Review Groups. Every SoF table included a median of 5 outcomes, for a total of 1414 outcomes; 1089 (77%) could be considered PIOs. Almost all reviews (n = 278, 96%) included at least one PIO in their SoF table. The quality of evidence for the outcomes was high for 12% (n = 168), moderate for 28% (n = 402) and low or very low for 45% (n = 640). Less than one quarter of reviews (n = 63) included at least one PIO with high-quality evidence that favoured a benefit of the experimental intervention evaluated in half of them (n = 34 reviews).

Conclusions: Many outcomes reported in the SoF table of recent Cochrane reviews can be considered PIOs. However, the quality of available evidence remains limited for these outcomes.

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References

Rahimi K, Malhotra A, Banning A, Jenkinson C . Outcome selection and role of patient reported outcomes in contemporary cardiovascular trials: systematic review. BMJ. 2010; 341:c5707. PMC: 2967478. DOI: 10.1136/bmj.c5707. View

Williamson P, Altman D, Blazeby J, Clarke M, Devane D, Gargon E . Developing core outcome sets for clinical trials: issues to consider. Trials. 2012; 13:132. PMC: 3472231. DOI: 10.1186/1745-6215-13-132. View

Page M, Shamseer L, Altman D, Tetzlaff J, Sampson M, Tricco A . Epidemiology and Reporting Characteristics of Systematic Reviews of Biomedical Research: A Cross-Sectional Study. PLoS Med. 2016; 13(5):e1002028. PMC: 4878797. DOI: 10.1371/journal.pmed.1002028. View

. Methodological standards and patient-centeredness in comparative effectiveness research: the PCORI perspective. JAMA. 2012; 307(15):1636-40. DOI: 10.1001/jama.2012.466. View

Ioannidis J, Horbar J, Ovelman C, Brosseau Y, Thorlund K, Buus-Frank M . Completeness of main outcomes across randomized trials in entire discipline: survey of chronic lung disease outcomes in preterm infants. BMJ. 2015; 350:h72. DOI: 10.1136/bmj.h72. View

Rosenbaum S, Glenton C, Oxman A . Summary-of-findings tables in Cochrane reviews improved understanding and rapid retrieval of key information. J Clin Epidemiol. 2010; 63(6):620-6. DOI: 10.1016/j.jclinepi.2009.12.014. View

Dechartres A, Ravaud P, Atal I, Riveros C, Boutron I . Association between trial registration and treatment effect estimates: a meta-epidemiological study. BMC Med. 2016; 14(1):100. PMC: 4932748. DOI: 10.1186/s12916-016-0639-x. View

Atkins D, Best D, Briss P, Eccles M, Falck-Ytter Y, Flottorp S . Grading quality of evidence and strength of recommendations. BMJ. 2004; 328(7454):1490. PMC: 428525. DOI: 10.1136/bmj.328.7454.1490. View

Williamson P, Clarke M . The COMET (Core Outcome Measures in Effectiveness Trials) Initiative: Its Role in Improving Cochrane Reviews. Cochrane Database Syst Rev. 2012; (5):ED000041. PMC: 10846459. DOI: 10.1002/14651858.ED000041. View

10.

Alonso-Coello P, Vernooij R, Carrasco-Labra A, Vandvik P, Guyatt G . RE: Which estimates comprise optimal reporting in systematic reviews?. J Clin Epidemiol. 2017; 81:140-141. DOI: 10.1016/j.jclinepi.2017.01.001. View

11.

Guyatt G, Montori V, Devereaux P, Schunemann H, Bhandari M . Patients at the center: in our practice, and in our use of language. ACP J Club. 2004; 140(1):A11-2. View

12.

Montori V, Gandhi G, Guyatt G . Patient-important outcomes in diabetes--time for consensus. Lancet. 2007; 370(9593):1104-6. DOI: 10.1016/S0140-6736(07)61489-5. View

13.

Glasziou P, Altman D, Bossuyt P, Boutron I, Clarke M, Julious S . Reducing waste from incomplete or unusable reports of biomedical research. Lancet. 2014; 383(9913):267-76. DOI: 10.1016/S0140-6736(13)62228-X. View

14.

Khan K, Kunz R, Kleijnen J, Antes G . Five steps to conducting a systematic review. J R Soc Med. 2003; 96(3):118-21. PMC: 539417. DOI: 10.1177/014107680309600304. View

15.

Guyatt G, Oxman A, Vist G, Kunz R, Falck-Ytter Y, Alonso-Coello P . GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008; 336(7650):924-6. PMC: 2335261. DOI: 10.1136/bmj.39489.470347.AD. View

16.

Richards T, Montori V, Godlee F, Lapsley P, Paul D . Let the patient revolution begin. BMJ. 2013; 346:f2614. DOI: 10.1136/bmj.f2614. View

17.

Ameur H, Ravaud P, Fayard F, Riveros C, Dechartres A . Systematic reviews of therapeutic interventions frequently consider patient-important outcomes. J Clin Epidemiol. 2017; 84:70-77. DOI: 10.1016/j.jclinepi.2017.01.006. View

18.

Alonso-Coello P, Carrasco-Labra A, Brignardello-Petersen R, Neumann I, Akl E, Vernooij R . Systematic reviews experience major limitations in reporting absolute effects. J Clin Epidemiol. 2015; 72:16-26. DOI: 10.1016/j.jclinepi.2015.11.002. View

19.

Gandhi G, Murad M, Fujiyoshi A, Mullan R, Flynn D, Elamin M . Patient-important outcomes in registered diabetes trials. JAMA. 2008; 299(21):2543-9. DOI: 10.1001/jama.299.21.2543. View

20.

Yordanov Y, Dechartres A, Atal I, Tran V, Boutron I, Crequit P . Avoidable waste of research related to outcome planning and reporting in clinical trials. BMC Med. 2018; 16(1):87. PMC: 5994653. DOI: 10.1186/s12916-018-1083-x. View