ORCID Profile
0000-0003-1716-993X
Current Organisations
Oslo Centre for Biostatistics and Epidemiology
,
University of Bristol
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Publisher: Public Library of Science (PLoS)
Date: 27-04-2022
DOI: 10.1371/JOURNAL.PMED.1003980
Abstract: We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether rates of completion and publication have increased (2) the extent to which nonpublished RCTs can be identified in trial registries and (3) the association between reporting quality of protocols and premature discontinuation or nonpublication of RCTs. We included 326 RCT protocols approved in 2012 by research ethics committees in Switzerland, the United Kingdom, Germany, and Canada in this metaresearch study. Pilot, feasibility, and phase 1 studies were excluded. We extracted trial characteristics from each study protocol and systematically searched for corresponding trial registration (if not reported in the protocol) and full text publications until February 2022. For trial registrations, we searched the (i) World Health Organization: International Clinical Trial Registry Platform (ICTRP) (ii) US National Library of Medicine ( ClinicalTrials.gov ) (iii) European Union Drug Regulating Authorities Clinical Trials Database (EUCTR) (iv) ISRCTN registry and (v) Google. For full text publications, we searched PubMed, Google Scholar, and Scopus. We recorded whether RCTs were registered, discontinued (including reason for discontinuation), and published. The reporting quality of RCT protocols was assessed with the 33-item SPIRIT checklist. We used multivariable logistic regression to examine the association between the independent variables protocol reporting quality, planned s le size, type of control (placebo versus other), reporting of any recruitment projection, single-center versus multicenter trials, and industry versus investigator sponsoring, with the 2 dependent variables: (1) publication of RCT results and (2) trial discontinuation due to poor recruitment. Of the 326 included trials, 19 (6%) were unregistered. Ninety-eight trials (30%) were discontinued prematurely, most often due to poor recruitment (37% 36/98). One in 5 trials (21% 70/326) remained unpublished at 10 years follow-up, and 21% of unpublished trials (15/70) were unregistered. Twenty-three of 147 investigator-sponsored trials (16%) reported their results in a trial registry in contrast to 150 of 179 industry-sponsored trials (84%). The median proportion of reported SPIRIT items in included RCT protocols was 69% (interquartile range 61% to 77%). We found no variables associated with trial discontinuation however, lower reporting quality of trial protocols was associated with nonpublication (odds ratio, 0.71 for each 10% increment in the proportion of SPIRIT items met 95% confidence interval, 0.55 to 0.92 p = 0.009). Study limitations include that the moderate s le size may have limited the ability of our regression models to identify significant associations. We have observed that rates of premature trial discontinuation have not changed in the past decade. Nonpublication of RCTs has declined but remains common 21% of unpublished trials could not be identified in registries. Only 16% of investigator-sponsored trials reported results in a trial registry. Higher reporting quality of RCT protocols was associated with publication of results. Further efforts from all stakeholders are needed to improve efficiency and transparency of clinical research.
Publisher: Cold Spring Harbor Laboratory
Date: 22-12-2022
DOI: 10.1101/2022.12.20.22283748
Abstract: The surge of the COVID-19 pandemic challenged health services globally, and in Lesotho, the HIV and tuberculosis (TB) services were similarly affected. Integrated, multi-disease diagnostic services were proposed solutions to mitigate these disruptions. We describe and evaluate the effect of an integrated, hospital-based COVID-19, TB and HIV screening and diagnostic model in two rural districts in Lesotho, during the period between December 2020 and August 2022. Adults and children above 5 years attending two hospitals were screened for COVID-19 and TB symptoms. After a positive screening, participants were offered to enroll in a service model that included clinical evaluation, chest radiography, SARS-CoV-2, Xpert MTB/RIF Ultra and HIV testing. Participants diagnosed with COVID-19, TB, or HIV were contacted after 28 days evaluate their health status, and linkage to HIV or TB services. Of the 179160 participants screened, 6623(37%) screened positive, and 4371(66%) were enrolled in this service model, yielding a total of 458 diagnoses. One positive rapid antigen test for SARS-CoV-2 was found per 11 participants screened, one Xpert-positive TB case was diagnosed per 85 people screened, and 1 new HIV diagnosis was done per 182 people screened. Of the 321(82.9%) participants contacted after 28 days of diagnosis, 304(94.7%) reported to be healthy. Of the in iduals that were newly diagnosed with HIV or TB, 18/24(75.0%) and 46/51(90.1%) started treatment. This service showed no difference in the detection of new HIV and TB cases when compared to other hospitals, where no such integrated service model was provided. This screening and diagnostic model successfully maintained same-day, integrated COVID-19, TB, and HIV testing services through different COVID-19 incidence periods in a resource-limited context. There were positive effects in avoiding diagnostic delays and ensuring linkage to services, however, efficiencies were contingent on the successful adaptation to the changing environment.
Location: United Kingdom of Great Britain and Northern Ireland
No related grants have been discovered for Alain Amstutz.