1,720,985 research outputs found
Transparent and complete reporting of surrogate endpoints in trials: the SPIRIT-and CONSORT-Surrogate extensions
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Surrogate endpoints in cardio-thoracic trials: a call for better reporting and improved interpretation of trial findings
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Reply to Commentary by Cummings (2022): Surrogate endpoints extend beyond biomarkers
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A call for better reporting of trials using surrogate primary endpoints
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Surrogate endpoints in randomised trials of physiotherapy interventions: the SPIRIT and CONSORT extension checklists for better reporting
Full text linkSurrogate endpoints in randomised trials of physiotherapy interventions: the SPIRIT and CONSORT extension checklists for better reportin
Sample size in multistakeholder Delphi surveys: at what minimum sample size do replicability of results stabilise?
Full text linkBackground
The minimum sample size for multistakeholder Delphi surveys remains understudied. Drawing from three large international multistakeholder Delphi surveys, this study aimed to: 1) investigate the effect of increasing sample size on replicability of results; 2) assess whether the level of replicability of results differed with participant characteristics: e.g., gender, age, profession.
Methods
We used data from Delphi surveys to develop guidance for improved reporting of healthcare intervention trials: SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) extension for surrogate endpoints (n=175, 22 items rated); CONSORT-SPI, extension for social and psychological interventions (n=333, 77 items rated); and core outcome set for burn care (n=553, 88 items rated). Resampling with replacement was used to draw random subsamples from the participant data set in each of the three surveys. For each subsample, the median value of all rated survey items was calculated and compared to the medians from the full participant data set. The median number (and interquartile range) of medians replicated was used to calculate the percentage replicability (and variability). High replicability was defined as ≥80% and moderate as 60% and <80%
Results
The average median replicability (variability) as a percentage of total number of items rated from the three datasets was 81% (10%) at a sample size of 60. In one of the datasets (CONSORT-SPI), a ≥80% replicability was reached at a sample size of 80. On average, increasing the sample size from 80 to 160 increased the replicability of results by a further 3% and reduced variability by 1%. For subgroup analysis based on participant characteristics (e.g. gender, age, professional role), using resampled samples of 20 to 100 showed that a sample size of 20 to 30 resulted to moderate replicability levels of 64 to 77%.
Conclusion
We found that a minimum sample size of 60 to 80 participants in multistakeholder Delphi surveys provide a high level of replicability (≥80%) in the results. For Delphi studies limited to individual stakeholder groups (such as researchers, clinicians, patients), a sample size of 20 to 30 per group may be sufficient
Scoping and targeted reviews to support development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: protocol
Full text linkIntroduction: Using a surrogate endpoint as a substitute for a primary patient-relevant outcome enables randomised controlled trials (RCTs) to be conducted more efficiently, that is, with shorter time, smaller sample size and lower cost. However, there is currently no consensus-driven guideline for the reporting of RCTs using a surrogate endpoint as a primary outcome; therefore, we seek to develop SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) extensions to improve the design and reporting of these trials. As an initial step, scoping and targeted reviews will identify potential items for inclusion in the extensions and participants to contribute to a Delphi consensus process.
Methods and analysis: The scoping review will search and include literature reporting on the current understanding, limitations and guidance on using surrogate endpoints in trials. Relevant literature will be identified through: (1) bibliographic databases; (2) grey literature; (3) handsearching of reference lists and (4) solicitation from experts. Data from eligible records will be thematically analysed into potential items for inclusion in extensions. The targeted review will search for RCT reports and protocols published from 2017 to 2021 in six high impact general medical journals. Trial corresponding author contacts will be listed as potential participants for the Delphi exercise.
Ethics and dissemination: Ethical approval is not required. The reviews will support the development of SPIRIT and CONSORT extensions for reporting surrogate primary endpoints (surrogate endpoint as the primary outcome). The findings will be published in open-access publications
Nutrition outcomes and interventions in older people in Africa: a systematic umbrella and scoping review
No full textAfrica's older population is rapidly increasing, necessitating the development of healthy aging interventions. Nutrition is a key component of healthy aging. Evidence synthesis on nutrition outcomes of older adults in Africa is emerging but a synthesis on interventions is lacking. The aim was to synthesize evidence from reviews on older people in Africa to determine the prevalence of nutrition outcomes and associated factors (phase 1) and implemented interventions (phase 2). Literature searches using Medline, EMBASE, Web of Science, African Index Medicus, and African Journals Online were conducted up to May 9, 2024. After screening, 25 reviews (for phase 1) and 22 articles (for phase 2) were selected for inclusion. Most reviews (n = 16; 64%) were systematic, with 8 having a meta-analysis, and published between 2020 and 2023 (n = 20; 80%). The pooled prevalence of malnutrition (being underweight) was 21% (evidence from 5 reviews), 26% for sarcopenia (1 review), 27% for obesity (3 reviews), 32% for constipation (1 review), 39% for food insecurity (2 reviews), 49% for dental caries (1 review), and 64% for vitamin D insufficiency and deficiency (2 reviews). The 22 articles on nutritional interventions represented only 6 countries, mostly South Africa (64%; 14/22), evaluated using randomized trials (n = 10; 45%) and educational interventions (n = 10; 45%). Reported interventions were not typically underpinned by supporting systematic reviews or a contextual evidence base, did not account for the minimally important clinical difference, lacked evidence of community engagement, and were not reported transparently. Nutritional research is needed on older adults outside of South Africa and beyond malnutrition. Future nutritional interventions (ideally, multicomponent) for older people in Africa should consider targeting the multiple nutritional and practical needs (eg, dietary counseling, supplementation) of older adults. Intervention development should be evidence-based, include engagement with older people, and follow complete and transparent reporting.</p
Understanding the aetiology of type 2 diabetes and the perceptions of diabetes risk in Nairobi, Kenya
No full textAbstract not currently available
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