Value of clinical research: Usefulness tool development and systematic
review of 350 randomised controlled trials in preterm birth
Abstract
Objective: We developed a research usefulness tool collating published
criteria and examined if randomised controlled trials (RCTs) addressing
preterm birth were useful. Search Strategy: Cochrane library. Selection
Criteria: Published RCTs within 56 preterm birth Cochrane reviews. Data
Collection and Analysis: A usefulness tool was developed with eight
criteria combining 13 items identified through literature searches and
consensus. RCTs were evaluated for compliance with each item by multiple
assessors (reviewer agreement 95-98%). Proportions with 95% confidence
interval (CI) were calculated and compared for change over time using ≧
2010 as a cut-off, with relative risks (RR). Main Results: Among 350
selected RCTs, only 38 (11%, 95% CI 8-15%) met half of the usefulness
criteria. Compared to trials before 2010, recent trials used composite
or surrogate (less informative) outcomes more often (13% vs 25%, RR
1.87, 95% CI 1.19-2.93). Only 17 trials reflected real life
(pragmatism) in design (5%, 95% CI 3-8%), with no improvements over
time. No trials reported involvement of mothers to reflect patients’ top
priorities in question definition or outcomes selection. Recent trials
were more transparent with prospective registration (0.5% vs 28%, RR
58, 95% CI 8-420%), availability of protocol (0.5% vs 15%, RR 32,
95% CI 4-237%) and data sharing statements (2% vs 8%, RR 3, 95% CI
1-10%). Conclusion: Clinical trials in preterm birth lacked many
usefulness features, with one tenth of trials meeting half of the items
evaluated. Use of informative outcomes, patient centeredness, pragmatism
and transparency should be key targets for future research planning.