Browsing by Author "Grimshaw, Jeremy M."

Now showing 1 - 2 of 2
  • Thumbnail Image
    Item
    Compliance of clinical trial registries with the World Health Organization minimum data set : a survey
    (BioMed Central, 2009-07) Moja, Lorenzo P.; Moschetti, Ivan; Nurbhai, Munira; Compagnoni, Anna; Liberati, Alessandro; Grimshaw, Jeremy M.; Chan, An-Wen; Dickersin, Kay; Krleza-Jeric, Karmela; Moher, David; Sim, Ida; Volmink, Jimmy
    Background: Since September 2005 the International Committee of Medical Journal Editors has required that trials be registered in accordance with the World Health Organization (WHO) minimum dataset, in order to be considered for publication. The objective is to evaluate registries' and individual trial records' compliance with the 2006 version of the WHO minimum data set. Methods: A retrospective evaluation of 21 online clinical trial registries (international, national, specialty, pharmaceutical industry and local) from April 2005 to February 2007 and a cross-sectional evaluation of a stratified random sample of 610 trial records from the 21 registries. Results: Among 11 registries that provided guidelines for registration, the median compliance with the WHO criteria were 14 out of 20 items (range 6 to 20). In the period April 2005–February 2007, six registries increased their compliance by six data items, on average. None of the local registry websites published guidelines on the trial data items required for registration. Slightly more than half (330/610; 54.1%, 95% CI 50.1% – 58.1%) of trial records completed the contact details criteria while 29.7% (181/610, 95% CI 26.1% – 33.5%) completed the key clinical and methodological data fields. Conclusion: While the launch of the WHO minimum data set seemed to positively influence registries with better standardisation of approaches, individual registry entries are largely incomplete. Initiatives to ensure quality assurance of registries and trial data should be encouraged. Peer reviewers and editors should scrutinise clinical trial registration records to ensure consistency with WHO's core content requirements when considering trial-related publications.
  • Thumbnail Image
    Item
    Reporting of health equity considerations in cluster and individually randomized trials
    (BMC (part of Springer Nature), 2020-04-03) Petkovic, Jennifer; Jull, Janet; Yoganathan, Manosila; Dewidar, Omar; Baird, Sarah; Grimshaw, Jeremy M.; Johansson, Kjell A.; Kristjansson, Elizabeth; McGowan, Jessie; Moher, David; Petticrew, Mark; Robberstad, Bjarne; Shea, Beverley; Tugwell, Peter; Volmink, Jimmy; Wells, George A.; Whitehead, Margaret; Cuervo, Luis G.; White, Howard; Taljaard, Monica; Welch, Vivian
    Background: The randomized controlled trial (RCT) is considered the gold standard study design to inform decisions about the effectiveness of interventions. However, a common limitation is inadequate reporting of the applicability of the intervention and trial results for people who are “socially disadvantaged” and this can affect policy-makers’ decisions. We previously developed a framework for identifying health-equity-relevant trials, along with a reporting guideline for transparent reporting. In this study, we provide a descriptive assessment of healthequity considerations in 200 randomly sampled equity-relevant trials. Methods: We developed a search strategy to identify health-equity-relevant trials published between 2013 and 2015. We randomly sorted the 4316 records identified by the search and screened studies until 100 individually randomized (RCTs) and 100 cluster randomized controlled trials (CRTs) were identified. We developed and pilottested a data extraction form based on our initial work, to inform the development of our reporting guideline for equity-relevant randomized trials. Results: In total, 39 trials (20%) were conducted in a low- and middle-income country and 157 trials (79%) in a high-income country focused on socially disadvantaged populations (78% CRTs, 79% RCTs). Seventy-four trials (37%) reported a subgroup analysis across a population characteristic associated with disadvantage (25% CRT, 49% RCTs), with 19% of included studies reporting subgroup analyses across sex, 9% across race/ethnicity/culture, and 4% across socioeconomic status. No subgroup analyses were reported for place of residence, occupation, religion, education, or social capital. One hundred and forty-one trials (71%) discussed the applicability of their results to one or more socially disadvantaged populations (68% of CRT, 73% of RCT). Discussion: In this set of trials, selected for their relevance to health equity, data that were disaggregated for socially disadvantaged populations were rarely reported. We found that even when the data are available, opportunities to analyze health-equity considerations are frequently missed. The recently published equity extension of the Consolidated Reporting Standards for Randomized Trials (CONSORT-Equity) may help improve delineation of hypotheses related to socially disadvantaged populations, and transparency and completeness of reporting of health-equity considerations in RCTs. This study can serve as a baseline assessment of the reporting of equity considerations.