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Effectiveness of using manual pill organisers and pill reminder apps in improving medication adherence and health outcomes in the Indian elderly population receiving multiple medications (PORA-MEDAdhere): protocol for a 2x2 factorial randomised controlled

Por: Apte · A. · Fathima · F. · Solanke · B. · Selvam · S. · Agarwal · D. · Sridhar · P. R. · Singh · H. · Balkhande · R. · Nimkar · R. · Patil · R. · Cherian · J. J. · Roy · S.
Introduction

Poor medication adherence is associated with poor clinical outcomes, an increase in hospitalisations and increased mortality. This is a multicentre randomised study that evaluates the effectiveness of using a manual pill organiser (MPO) and a custom-developed pill reminder app (PRA) on medication adherence, morbidity, as well as health economic outcomes among Indian elderly individuals taking multiple medications.

Objectives

The primary objective of this study is to evaluate the impact of MPO and PRA alone or in combination in improving medication adherence among elderly individuals on multiple medications. The secondary objectives include the impact of interventions on the morbidity profile and health-related quality of life. The study also plans to assess the cost-effectiveness and cost-utility of improving medication adherence.

Methods and analysis

This is a community-based, open-label, factorial-design randomised controlled trial to be conducted across rural and urban populations at two geographically distinct sites in India. The study will enrol 752 elderly individuals aged 60–80 years, receiving three or more medications for at least 6 months and having access to smartphones. The participants will be randomised to receive one of the following interventions for 12 months: control group, PRA, MPO and MPO+PRA. All study groups would receive patient education about the importance of medication adherence. The study outcomes include the proportion of improvement in medication adherence (using Medication Adherence Rating System-5, 7-day point prevalence of medication non-adherence and pill count); adverse clinical outcomes; healthcare utilisation; health-related quality of life; cost-effectiveness and cost-utility outcomes.

Ethics and dissemination

The study protocol has been approved by institutional ethics committees at all three institutes. The study results for primary and secondary outcomes will be published in peer-reviewed journals.

Trial registration number

CTRI/2024/01/061975 (Registered on: 29 January 2024).

Personality traits, panel tenure, survey topic, and context as predictors of survey nonresponse patterns in high-frequency online longitudinal surveys

by Htay-Wah Saw, Arie Kapteyn

An extensive literature studies the relation between demographic and socio-economic characteristics and attrition in longitudinal studies. In this study, we analyze the independent effects of non-demographic variables—respondent personality traits, panel tenure, and survey topics, using unique datasets from two recently completed high-frequency online longitudinal studies conducted in the U.S. We used latent class analysis to group respondents into various classes based on similarities in their nonresponse patterns across all survey waves, which revealed substantial variations in patterns of nonresponse. Our results indicate that respondent personality traits were strong predictors of nonresponse patterns. Specifically, conscientiousness is positively associated with a lower likelihood of wave nonresponses. In contrast, more open, extroverted, neurotic, and agreeable respondents are more likely to exhibit higher wave nonresponses, but with effect sizes smaller than that of conscientiousness. We found no significant demographic effects on wave nonresponse in one of the studies focused on aging and well-being. However, in the study primarily focused on COVID-19-related topics conducted during the pandemic, we found a few significant demographic effects. Collectively, our findings suggest that personality traits may play a more significant role than conventional demographic and household variables in predicting nonresponse patterns in high frequency (at least one survey per month) online surveys.

Clinical evaluation of adults undergoing elective surgery utilizing intraoperative incisional wound irrigation (CLEAN Wound): protocol for a randomised controlled trial

Por: Roke · R. · Lillie · E. · Daneman · N. · Mason · S. A. · Tomlinson · G. · Jiang · Y. · Shiroky · J. · Puran · S. · Smith · D. E. · Abou Khalil · J. · Kayssi · A. · Serrano · P. E. · Pinchuk · B. · Apte · S. S. · Lamb · T. · Ma · G. · Vogt · K. · Leslie · K. · Mutabdzic · D. · Gomez · D. · Ladh
Introduction

In moderate to high-risk surgical procedures, 15–25% of patients develop a postoperative surgical site infection. Intraoperative incisional wound irrigation has the potential to reduce surgical site infections, and additional randomised controlled trials are required to provide evidence of effectiveness.

Methods and analysis

This protocol describes a pragmatic, adaptive, participant and adjudicator-blinded trial at 13 sites in Canada in up to 2500 participants. Participants planned for surgery with an abdominal or groin incision, who are eligible and provide verbal consent through an integrated consent model, are randomised to receive intraoperative incisional wound irrigation with povidone-iodine, saline or no irrigation. The primary outcome is surgical site infection within 30 days postoperatively. Secondary outcomes include quality of life measured 30 days postoperatively and morbidity, mortality and healthcare utilisation within 90 days postoperatively.

Ethics and dissemination

This trial has been approved by the research ethics board at the participating centres and stopped enrolling participants on May 23, 2025. All participants will provide verbal consent. Results will be disseminated via presentation at conferences, publication and posted on clinicaltrials.gov.

Trial registration number

The study is registered with http://clinicaltrial.gov (NCT04548661; 14 September 2020).

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