STUDY DESIGN AND SETTINGS: The Online Randomized Controlled Trials of Health Information Database was used as the sampling frame to identify a subset of self-recruited online trials of self-management interventions. The authors cataloged what these online trials were assessing, appraised study quality, extracted information on how trials were run, and assessed the potential for bias. We searched out how public and patient participation was integrated into online trial design and how this was reported. We recorded patterns of use for registration, reporting, settings, informed consent, public involvement, supplementary materials, and dissemination planning.
RESULTS: The sample included 41 online trials published from 2002 to 2015. The barriers to replicability and risk of bias in online trials included inadequate reporting of blinding in 28/41 (68%) studies; high attrition rates with incomplete or unreported data in 30/41 (73%) of trials; and 26/41 (63%) of studies were at high risk for selection bias as trial registrations were unreported. The methods for (23/41, 56%) trials contained insufficient information to replicate the trial, 19/41 did not report piloting the intervention. Only 2/41 studies were cross-platform compatible. Public involvement was most common for advisory roles (n = 9, 22%), and in the design, usability testing, and piloting of user materials (n = 9, 22%).
CONCLUSION: This study catalogs the state of online trials of self-management in the early 21st century and provides insights for online trials development as early as the protocol planning stage. Reporting of trials was generally poor and, in addition to recommending that authors report their trials in accordance with CONSORT guidelines, we make recommendations for researchers writing protocols, reporting on and evaluating online trials. The research highlights considerable room for improvement in trial registration, reporting of methods, data management plans, and public and patient involvement in self-recruited online trials of self-management interventions.
DESIGN: A 2 x 2 factorial randomized controlled trial design. Two hundred forty new adult patients (60 in each group) were randomized to: information (info) only; info + prompt; info + plan; or info + prompt + plan. All participants received treatment as usual in addition to I-PLAN components, which were provided in a sealed envelope at the end of the hearing aid fitting consultation. Participants in the prompt group were instructed to use their hearing aid box as a physical prompt to remind them to use the device. Participants in the plan group were instructed to write an action plan to encourage them to turn their intentions into action. Participants, audiologists, and researchers were blinded to group allocation. The primary outcome was self-reported proportion of time hearing aids were used in situations where they had listening difficulties. Secondary outcomes were hearing aid use derived from data logging, self-reported hearing aid benefit, self-reported self-regulation, and habit. Outcomes were measured at 6-week post-fitting.
RESULTS: Contrary to predictions, participants who received the prompt component reported using their hearing aid less than participants without the prompt (p = 0.03; d = 0.24). The mean proportion of time hearing aid were used was 73.4% of the time in the prompt group compared with 79.9% of the time in the no prompt group. Participants who received the plan component reported using their hearing aids more frequently than those who did not receive the plan (Meanplan = 81.0% vs Meannoplan = 71.8% of the time; p = 0.01; d = 0.34). Receiving both prompt and plan components did not change self-reported proportion of time hearing aids were used but data-logging use was significantly reduced. The prompt reduced self-regulation of hearing aid use compared with the no prompt (p = 0.04; d = 0.28), while the plan promoted stronger hearing aid use habits than the no plan group (p = 0.02; d = 0.30).
CONCLUSIONS: Audiologists should consider using action plans to promote hearing aid use. Despite the decrease in hearing aid use when using the hearing aid box as a physical prompt, hearing aid use was still high (≈70% of the time). The hearing aid box may have slightly reduced hearing aid use by undermining self-regulation. Participants may have delegated responsibility for hearing aid use to the prompt. Subsequent studies should evaluate different prompts and test the long-term benefit of the plan on hearing aid use via habit formation.
MATERIALS AND METHODS: A cross-sectional study involving 86 respondents was conducted using an online survey between the middle of March and April 2022. The Perceived Stress Scale (PSS) developed by Cohen et al., (1983) was used to assess the stress levels of individuals. Data analysis was carried out using the SPSS statistical program, which included descriptive statistics, Mann-Whitney, Kruskal Wallis and Linear Regression tests.
RESULTS: The majority of respondents, 75.6% (n=65) reported moderate stress levels, while 14.0% (n=12) declared severe stress levels. The Mann-Whitney test showed no significant difference in psychosocial stress scores among workers between onshore and offshore (χ2=-0.523, p=0.601), whereas the Kruskal Wallis test showed a significant difference in psychosocial stress scores among workers between states (PMA, SKA, and SBA) (χ2=6.415, p=0.040). According to the regression test, workers with medical histories of diabetes and Covid-19 (R2=0.158) (p<0.005) are two factors linked to psychosocial stress.
CONCLUSION: The study found that there were significant differences in psychosocial stress among oil and gas workers between SKA, SBA, and PMA due to quarantine activity. Mobile workers and those with certain medical histories were identified as being particularly vulnerable to psychosocial stress. However, it was noted that the overall improvement in the quarantine period had a positive impact on the mental health of these workers.
MATERIAL AND METHODS: This cluster randomised controlled trial (RCT) will involve 207 Arab students (14-18 years old) from 12 Arabic schools in the Klang Valley. The schools will be assigned randomly to an intervention (online life skills programme) or control group at a 1:1 ratio. The researcher will deliver eight one-hour sessions to the intervention group weekly. The control group will receive the intervention at the evaluation end. Both groups will complete assessments at baseline, and immediately and three months after the intervention. The primary outcome is anxiety, depression, and stress [Depression Anxiety and Stress Scale-21 (DASS-21)]. The secondary outcomes are self-efficacy (General Self-Efficacy Scale) and coping skills (Brief COPE Inventory). Data analysis will involve the Generalised Estimation Equation with a 95% confidence interval. P < .05 will indicate significant inter- and intra-group differences.
DISCUSSION: This will be the first cluster RCT of an online life skills education programme involving Arab adolescent migrants in Malaysia. The results could support programme effectiveness for improving the participants' mental health problems (depression, anxiety, stress), increasing their self-efficacy, and enhancing their coping skills. The evidence could transform approaches for ameliorating migrant children and adolescents' mental well-being.
TRIAL REGISTRATION: The study is registered with the Clinical Trial Registry (Identifier: NCT05370443).
METHODS: Study within a trial of an international parallel group randomized controlled trial (RCT) that compares spironolactone to placebo. Adults receiving dialysis enter an 8-week active run-in period with spironolactone. Adherence was assessed by both self-report and pill counts in a subgroup of participants at both 3 weeks and 7 weeks.
RESULTS: 332 participants entered the run-in period of which 166 had complete data. By self-report, 146/166 (94.0%) and 153/166 (92.2%) had at least 80% adherence at 3 and 7 weeks respectively (kappa = 0.27 (95% C.I. 0.16 to 0.38). By pill counts, the mean (SD) adherence was 96.5% (16.1%) and 92.4% (18.2%) at 3 and 7 weeks respectively (r = 0.32) with a mean (SD) difference of 3.1% (17.8%) and a 95% limit of agreement from -31.7% to +37.9%. The proportion of adherent participants by self-report and pill counts at 3 weeks agreed in 87.4% of participants (McNemar's p-value 0.58, kappa 0.11, p = 0.02) and at 7 weeks agreed in 92.2% (McNemar's p-value 0.82, kappa 0.47, p self-reported and pill count assessments performed similarly.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03020303.
METHODS: The first and second COVAD patient self-reported e-surveys were circulated from March to December 2021, and February to June 2022 (ongoing). We collected data on demographics, comorbidities, COVID-19 infection and vaccination history, reasons for hesitancy, and patient reported outcomes. Predictors of hesitancy were analysed using regression models in different groups.
RESULTS: We analysed data from 18 882 (COVAD-1) and 7666 (COVAD-2) respondents. Reassuringly, hesitancy decreased from 2021 (16.5%) to 2022 (5.1%) (OR: 0.26; 95% CI: 0.24, 0.30, P
OBJECTIVE: This study aims to develop and validate SafeHIT, an instrument to assess self-reported safe use of HIT among health care practitioners.
METHODS: Systematic literature review and a semistructured interview with 31 experts were adopted to generate SafeHIT instrument items. In total, 450 physicians from various departments at three Malaysian public hospitals participated in the questionnaire survey to validate SafeHIT. Exploratory factor analysis and confirmatory factor analysis (CFA) were undertaken to explore the items that best represent a specific construct and to confirm the reliability and validity of the SafeHIT, respectively.
RESULTS: The final SafeHIT consisted of 14 constructs and 58 items in total. The result of the CFA confirmed that all constructs demonstrated adequate convergent and discriminant validity.
CONCLUSION: A reliable and valid theoretically underpinned measure of determinants of safe HIT use behavior has been developed. Understanding external factors that influence safe HIT use is useful for developing targeted interventions that favor the quality and safety of health care.
METHODS: This multi-center, cross-sectional web-based questionnaire survey was conducted on HCWs during the outbreak of COVID-19 from August 2020 to January 2021. HCWs working in hospitals from 48 different countries were invited to participate in an online anonymous survey that investigated sociodemographic data, psychological distress, burnout and structural empowerment (SE) based on Depression Anxiety and Stress Scale 21 (DASS-21), Maslach Burnout Inventory (MBI) and Conditions for work effectiveness questionnaire (CWEQ_II), respectively. Predictors of the total scores of DASS-21, MBI and CWEQ-II were assessed using unadjusted and adjusted binary logistic regression analysis.
RESULTS: Out of the 1030 HCWs enrolled in this survey, all completed the sociodemographic section (response rate 100%) A total of 730 (70.9%) HCWs completed the DASS-21 questionnaire, 852 (82.6%) completed the MBI questionnaire, and 712 (69.1%) completed the CWEQ-II questionnaire. The results indicate that 360 out of 730 responders (49.3%) reported severe or extremely severe levels of stress, anxiety, and depression. Additionally, 422 out of 851 responders (49.6%) reported a high level of burnout, while 268 out of 712 responders (37.6%) reported a high level of structural empowerment based on the DASS-21, MBI, and CWEQ-II scales, respectively. In addition, the analysis showed that HCWs working in the COVID-19 areas experienced significantly higher symptoms of severe stress, anxiety, depression and higher levels of burnout compared to those working in other areas. The results also revealed that direct work with COVID-19 patients, lower work experience, and high workload during the outbreak of COVID-19 increase the risks of negative psychological consequences.
CONCLUSION: Health professionals had high levels of burnout and psychological symptoms during the COVID-19 emergency. Monitoring and timely treatment of these conditions is needed.