Background The conduct of high-quality pilot studies can help inform the success of larger clinical trials. Guidelines have been recently developed for the reporting of pilot trials. Objective This methodological survey evaluates the completeness of reporting in pilot randomized controlled trials in chronic kidney disease patients on hemodialysis (HD patients) and explores factors associated with better completion of reporting. Methods The authors searched Pubmed on July 1, 2018, for all pilot trials conducted in HD patients. Reporting quality was assessed against the 40-item Consolidated Standards of Reporting Trials (CONSORT) Extension for Pilot Trials. Study factors including year and country of publication, intervention, number of centers, type of funding, and journal endorsement of CONSORT were also examined. Results The mean number of items reported from the CONSORT extension for pilot trials across all included articles was 18.4 (standard deviation [SD] = 4.4). In the adjusted analysis, studies reported in later years (IRR = 1.026, 95% CI [1.018, 1.034], p < 0.001) and an increase of 20 persons in sample size (adjusted IRR = 1.021, 95% CI [1.010, 1.031], p < 0.001) were associated with a significantly higher number of CONSORT pilot items reported. Conclusions Current reporting completeness of pilot trials in HD patients is suboptimal. Endorsing the CONSORT extension specific to pilot and feasibility studies and ensuring that pilot trials focus on the feasibility objectives may improve reporting completeness of these trials. Electronic supplementary material The online version of this article (10.1186/s40814-019-0436-3) contains supplementary material, which is available to authorized users.
Background Pilot studies are essential in determining if a larger study is feasible. This is especially true when targeting populations that experience stigma and may be difficult to include in research, such as people with HIV. We sought to describe how pilot studies have been used to inform HIV clinical trials. Methods We conducted a methodological study of pilot studies of interventions in people living with HIV published until November 25, 2020, using Medline, Embase, and Cochrane Controlled Register of Trials (CENTRAL). We extracted data on their nomenclature, primary objective, use of progression criteria, sample size, use of qualitative methods, and other contextual information (region, income, level, type of intervention, study design). Results Our search retrieved 10,597 studies, of which 248 were eligible. The number of pilot studies increased steadily over time. We found that 179 studies (72.2%) used the terms “pilot” or “feasibility” in their title, 65.3% tested feasibility as a primary objective, only 2% used progression criteria, 23.9% provided a sample size estimation and only 30.2% used qualitative methods. Conclusions Pilot studies are increasingly being used to inform HIV research. However, the titles and objectives are not always consistent with piloting. The design and reporting of pilot studies in HIV could be improved.
Although the merits of in person learning outweigh those of virtual learning for elementary students, online learning is often implemented in response to rising cases of COVID-19. As such, the significant number of barriers to remote learning must be addressed in order to promote effective and health conscious learning for students during the pandemic. Students have been facing challenges with self-regulation, work management and lack of socio-emotional connections while teachers have been facing obstacles related to effectively using technology to deliver content and engage students. Parents have struggled to understand and fulfill their role supporting their children within the online school environment. Considering the perspectives presented in the literature, efforts should be made to promote connectedness and support for families during this difficult time. A resource toolkit is suggested for caregivers of children enrolled in online school to implement strategies at home to assist their children in their education.
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