Outcomes for patients with the same disease treated inside and outside of randomized trials: a systematic review and meta-analysis

Fernandes, Natasha; Bryant, Dianne; Griffith, Lauren; El-Rabbany, Mohamed; Fernandes, Nisha M.; Kean, Crystal O.; Marsh, Jacquelyn; Mathur, Siddhi; Moyer, R.; Reade, Clare J.; Riva, John J.; Somerville, Lyndsay; Bhatnagar, Neera

doi:10.1503/cmaj.131693

Cited by 23 publications

(29 citation statements)

References 151 publications

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“…Similarly, meta-analyses of studies of adults and older children demonstrate no significant differences in outcomes between trial participants and non-participants who were treated similarly outside trials. 4,5 …”

Section: Discussionmentioning

confidence: 99%

Short-term Outcomes of Infants Enrolled in Randomized Clinical Trials vs Those Eligible but Not Enrolled

Foglia

Nolen

DeMauro

et al. 2015

JAMA

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It is unknown whether participation in a neonatal randomized clinical trial (RCT) is independently associated with differences in outcomes. Our objective was to compare in-hospital outcomes between extremely premature infants enrolled in RCTs and those who were eligible but not enrolled in RCTs conducted by the National Institute of Child Health and Human Development Neonatal Research Network (NRN).Methods | A retrospective analysis of infants at NRN sites between January 1, 1999, and December 31, 2012, was performed. Included infants were eligible for NRN RCTs and had outcomes recorded in the NRN very low-birth-weight registry (Generic Database [GDB]). We excluded cluster randomized trials, trials of investigational therapies (to ensure that enrolled and nonenrolled infants were likely to be treated similarly), and infants eligible for the Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial (a similar analysis was previously published). 1

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Section: Discussionmentioning

confidence: 99%

Short-term Outcomes of Infants Enrolled in Randomized Clinical Trials vs Those Eligible but Not Enrolled

Foglia

Nolen

DeMauro

et al. 2015

JAMA

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“…Trial participants receive care under enhanced oversight above and beyond usual care, which is ensured by ethics and governance approvals, data and safety monitoring, and protocol compliance. Yet research on the effect of participation in trials versus non‐participation has not consistently shown evidence of benefit . This may be because the way innovations tested in trials differ from care outside trials varies by clinical area, and combining data from a number of specialities into a single synthesis can mask an effect.…”

Section: Introductionmentioning

confidence: 99%

“…Previous reviews on effect of participation in trials have not examined speciality subgroups. Research in women's health, which tends to be publicly funded, with industry funding lagging behind, is unique in many ways: for example, due to the combination of mother and offspring as a single unit, the social and cultural sensitivities in gynaecology, complex disease processes, interventions and outcomes, which may predispose participants to benefit or harm in a manner that cannot be surmised from the broad syntheses previously reported …”

Section: Introductionmentioning

confidence: 99%

“…Yet research on the effect of participation in trials versus nonparticipation has not consistently shown evidence of benefit. [5][6][7][8] This may be because the way innovations tested in trials differ from care outside trials 9,10 varies by clinical area, and combining data from a number of specialities into a single synthesis can mask an effect.…”

Section: Introductionmentioning

confidence: 99%

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Participation in clinical trials improves outcomes in women's health: a systematic review and meta‐analysis

Nijjar

D’Amico

Wimalaweera³

et al. 2017

BJOG

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Background Previous reviews examining the effect of participation in trials on outcomes have not consistently shown benefit. Obstetrics and gynaecology is a unique disease area posing challenges for both researchers and patients.Objectives To determine whether participation in randomised controlled trials (RCTs), compared with non-participation, has a beneficial effect on women's health.Search strategy Medline, Embase, the Cochrane Library, and PsycInfo were searched up to December 2015.Selection criteria We selected studies that reported the same clinical outcomes for participants in a women's health RCT and a comparable non-participant cohort.Data collection and analysis Data were extracted on quality, characteristics and study results. Outcomes were compared using logistic regression.Main results There were 21 relevant studies (20 160 women, 4759 outcome events). Trial participants, compared with nonparticipants, had 25% better odds of improved outcomes on average (OR 0.75; 95% CI 0.64-0.87; I 2 = 64.3%). The beneficial effect of participating in a trial was larger in comparisons where: RCTs were of high quality (OR 0.62; 95% CI 0.50-0.76) versus low (OR 0.92; 95% CI 0.74-1.16); and RCT intervention was not available to non-participants (OR 0.57; 95% CI 0.47-0.69) versus when it was (OR 1.13; 95% CI 0.89-1.44). The effect of trial participation was not influenced by effect size within the RCT (P = 0.48), whether funding was received or not (P = 0.13), whether non-participants received any treatment or not (P = 0.49), and the quality of the comparison of RCT participants with non-participants (P = 0.88).Conclusions Women participating in RCTs on average experienced better outcomes compared with those outside trials.Keywords Neonate, randomised, systematic review, trial participation, women's health.Tweetable abstract Participants in obstetric and gynaecology RCTs experience better outcomes compared with nonparticipants.Please cite this paper as: Nijjar SK, D'Amico MI, Wimalaweera NA, Cooper NAM, Zamora J, Khan KS. Participation in clinical trials improves outcomes in women's health: a systematic review and meta-analysis.

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“…It is well-established that those admitted to a SU are more likely to receive evidence-based clinical practices and have better survival compared to those receiving only care in general wards. 7,8,10 Alternatively, results from one review provide evidence of a positive effect on patient outcomes if they are involved in trials. The previous review articles present mixed results on outcomes and include studies of varying methodologic strength and quality.…”

Section: Figurementioning

confidence: 99%

Improved in-hospital outcomes and care for patients in stroke research

et al. 2016

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Outcomes for patients with the same disease treated inside and outside of randomized trials: a systematic review and meta-analysis

Cited by 23 publications

References 151 publications

Short-term Outcomes of Infants Enrolled in Randomized Clinical Trials vs Those Eligible but Not Enrolled

Short-term Outcomes of Infants Enrolled in Randomized Clinical Trials vs Those Eligible but Not Enrolled

Participation in clinical trials improves outcomes in women's health: a systematic review and meta‐analysis

Improved in-hospital outcomes and care for patients in stroke research

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