Participant Dropout Research Articles

Eleven Years of Change: Disease Progression in Biomarker-Defined Sporadic Parkinson's Disease.

Long-term longitudinal data on outcomes in sporadic Parkinson's Disease are limited, especially from cohorts with extensive biological characterization. Recent advances in biomarkers characterization of Parkinson's Disease necessitate an updated examination of long-term progression within contemporary cohorts like the Parkinson's Progression Markers Initiative, which enrolled individuals within 2 years of clinical diagnosis of Parkinson's Disease. Our study leverages the Neuronal Synuclein Disease framework, which defines the disease based on biomarker assessed presence of neuronal alpha-synuclein and dopamine deficit, rather than based on conventional clinical diagnostic criteria. In this study we aimed to provide a comprehensive long-term description of disease progression using the integrated biological and clinical staging system framework. We analyzed data from 344 participants from the sporadic Parkinson's Disease cohort in the Parkinson's Progression Markers Initiative, who met Neuronal Synuclein Disease criteria. We assessed 11-year progression in a spectrum of clinical measures. We used Cox proportional hazards models to assess the association between baseline stage and time to key outcomes, including survival, postural instability (Hoehn & Yahr ≥ 3), loss of independence (Schwab & England < 80%), cognitive decline, and domain-based milestones such as walking and balance, motor complications, autonomic dysfunction, and activities of daily living. Additional analyses were completed to account for death and participant dropout. Biomarker analysis included dopamine transporter binding measures, as well as serum urate, neurofilament light chain and CSF amyloid-beta, phosphorylated tau and total tau. At baseline, despite the cohort consisting of individuals within 2 years of clinical diagnosis, there was clear separation of participants in Neuronal Synuclein Disease Stages (23% Stage 2b, 67% Stage 3, 10% Stage 4). At 11 years, data were available for 153 participants; 35 participants had died over the follow up period. Of retained participants, 59% presented normal cognition, 24% had evidence of postural instability and mean Schwab & England score was 78.5. Serum neurofilament light chain consistently increased over time. No other biofluids had a consistent change in trajectory. Of importance, baseline Neuronal Synuclein Disease Stage predicted progression to clinically meaningful milestones. This study provides data on longitudinal, 11-year progression in Neuronal Synuclein Disease participants within 2 years of clinical diagnosis. We observed better long-term outcomes in this contemporary observational study cohort. It highlights the heterogeneity in the early Parkinson's Disease population as defined by clinical diagnostic criteria and underscores the importance of shifting from clinical to biologically and functionally based inclusion criteria in the design of new clinical trials.

Identifying the association between serum urate levels and gout flares in patients taking urate-lowering therapy: a post hoc cohort analysis of the CARES trial with consideration of dropout

ObjectiveTo investigate gout flare rates based on repeated serum urate (SU) measurements in a randomised controlled trial of urate-lowering therapy (ULT), accounting for dropout and death.MethodsWe performed a secondary analysis...

Framework Development for Reducing Attrition in Digital Dietary Interventions: Systematic Review and Thematic Synthesis.

Dietary behaviors significantly influence health outcomes across populations. Unhealthy diets are linked to serious diseases and substantial economic burdens, contributing to approximately 11 million deaths and significant disability-adjusted life years annually. Digital dietary interventions offer accessible solutions to improve dietary behaviors. However, attrition, defined as participant dropout before intervention completion, is a major challenge, with rates as high as 75%-99%. High attrition compromises intervention validity and reliability and exacerbates health disparities, highlighting the need to understand and address its causes. This study systematically reviews the literature on attrition in digital dietary interventions to identify the underlying causes, propose potential solutions, and integrate these findings with behavior theory concepts to develop a comprehensive theoretical framework. This framework aims to elucidate the behavioral mechanisms behind attrition and guide the design and implementation of more effective digital dietary interventions, ultimately reducing attrition rates and mitigating health inequalities. We conducted a systematic review, meta-analysis, and thematic synthesis. A comprehensive search across 7 electronic databases (PubMed, MEDLINE, Embase, CENTRAL, Web of Science, CINAHL Plus, and Academic Search Complete) was performed for studies published between 2013 and 2023. Eligibility criteria included original research exploring attrition in digital dietary interventions. Data extraction focused on study characteristics, sample demographics, attrition rates, reasons for attrition, and potential solutions. We followed ENTREQ (Enhancing the Transparency in Reporting the Synthesis of Qualitative Research) and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and used RStudio (Posit) for meta-analysis and NVivo for thematic synthesis. Out of the 442 identified studies, 21 met the inclusion criteria. The meta-analysis showed mean attrition rates of 35% for control groups, 38% for intervention groups, and 40% for observational studies, with high heterogeneity (I²=94%-99%) indicating diverse influencing factors. Thematic synthesis identified 15 interconnected themes that align with behavior theory concepts. Based on these themes, the force-resource model was developed to explore the underlying causes of attrition and guide the design and implementation of future interventions from a behavior theory perspective. High attrition rates are a significant issue in digital dietary interventions. The developed framework conceptualizes attrition through the interaction between the driving force system and the supporting resource system, providing a nuanced understanding of participant attrition, summarized as insufficient motivation and inadequate or poorly matched resources. It underscores the critical necessity for digital dietary interventions to balance motivational components with available resources dynamically. Key recommendations include user-friendly design, behavior-factor activation, literacy training, force-resource matching, social support, personalized adaptation, and dynamic follow-up. Expanding these strategies to a population level can enhance digital health equity. Further empirical validation of the framework is necessary, alongside the development of behavior theory-guided guidelines for digital dietary interventions. PROSPERO CRD42024512902; https://tinyurl.com/3rjt2df9.

Clinical benefits of self-guided mindfulness coach mobile app use for veterans with posttraumatic stress disorder: A pilot randomized control trial.

Mindfulness training can relieve posttraumatic stress disorder (PTSD) symptoms in military veterans and others but is inconsistently accessible. Self-guided mobile apps could improve access but their acceptability, feasibility, and benefits for veterans with PTSD have not been established. We conducted a pilot randomized trial of Mindfulness Coach (MC), a free, publicly available, trauma-informed mobile app tailored to veterans. U.S. veterans with PTSD (n = 173) were randomized to self-guided use of MC or waitlist control (WLC) with 8-week follow-up. Clinical outcomes were PTSD symptoms (PTSD Symptom Checklist-5), depression symptoms (Patient Health Questionnaire, nine item), and psychosocial functioning (Brief Inventory of Psychosocial Functioning). Primary analyses were intent-to-treat using linear mixed models with maximum likelihood estimation. App uptake, objective usage, and usability ratings measured acceptance and feasibility. Participants varied in age, gender, and ethnoracial identity; most reported recent mental health care utilization. Although study attrition was high (68.4% overall) due to participant dropout (treatment: 43.0%; control: 43.7%) and technical study issues (23% overall), diagnostic tests showed no evidence of bias due to missingness. Study completers (MC: n = 19; WLC: n = 37) showed medium effects on PTSD symptoms (b = -9.31, d = -0.69) and depression (b = -3.10, d = -0.52). Higher-intensity users showed greater benefits. App engagement trended lower for women and minoritized subpopulations. No changes were observed in psychosocial functioning. Usability and helpfulness ratings were favorable. Transdiagnostic clinical benefits indicate promise for MC as a public health resource for veterans with PTSD. Further study is warranted to confirm these benefits and ensure consistent engagement across subpopulations. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Hyperalgesia in Patients With a History of Opioid Use Disorder

Short-term and long-term opioid treatment have been associated with increased pain sensitivity (ie, opioid-induced hyperalgesia). Treatment of opioid use disorder (OUD) mainly involves maintenance with methadone and buprenorphine, and observations of heightened cold pain sensitivity among patients are often considered evidence of opioid-induced hyperalgesia. To critically examine the evidence that hyperalgesia in patients with OUD is related to opioid use. Web of Science, PubMed, and Embase between March 1, 2023, and April 12, 2024, were searched. Studies assessing cold pressor test (CPT) pain responses during treatment seeking, pharmacological treatment, or abstinence in patients with OUD history were included. Multilevel random-effects models with robust variance estimation were used for all analyses. Study quality was rated with the JBI checklist. Funnel plots and Egger regression tests were used to assess reporting bias. Main outcomes were pain threshold, tolerance, and intensity in patients and healthy controls, and unstandardized, standardized (Hedges g), and percentage differences (%Δ) in these measures between patients and controls. The association between pain sensitivity and opioid tolerance, withdrawal, and abstinence indices was tested with meta-regression. Thirty-nine studies (1385 patients, 741 controls) met the inclusion criteria. Most studies reported CPT data on patients undergoing opioid agonist treatment. These patients had a mean 2- to 3-seconds lower pain threshold (95% CI, -4 to -1; t test P = .01; %Δ, -22%; g = -0.5) and 29-seconds lower pain tolerance (95% CI, -39 to -18; t test P < .001; %Δ, -52%; g = -0.9) than controls. Egger tests suggested that these differences may be overestimated. There were some concerns of bias due to inadequate sample matching and participant dropout. Meta-regressions yielded no clear support for hyperalgesia being opioid related. Patients receiving opioid agonist treatment for OUD are hypersensitive to cold pain. It remains unclear whether hyperalgesia develops prior to, independent of, or as a result of long-term opioid treatment. Regardless, future studies should investigate the impact of hyperalgesia on patients' well-being and treatment outcomes.

Resilient Stress Reactivity Profiles Predict Mental Health Gains from Online Contemplative Training: A Randomized Clinical Trial.

Low-dose app-based contemplative interventions for mental health are increasingly popular, but heterogeneity in intervention responses indicates that a personalized approach is needed. We examined whether different longitudinal resilience-vulnerability trajectories, derived over the course of the COVID-19 pandemic, predicted differences in diverse mental health outcomes after mindfulness and socio-emotional dyadic online interventions. The CovSocial project comprised a longitudinal assessment (phase 1) and an open-label efficacy trial (phase 2). A community sample of 253 participants received 12 min daily app-based socio-emotional dyadic or mindfulness-based interventions, with weekly online coaching for 10 weeks. Before and after the intervention, participants completed validated self-report questionnaires assessing mental health. Stress reactivity profiles were derived from seven repeated assessments during the COVID-19 pandemic (January 2020 to March/April 2021) and were categorized into resilient (more plasticity) or vulnerable (less plasticity) stress recovery profiles. After both interventions, only individuals with resilient stress reactivity profiles showed significant improvements in depression symptomatology, trait anxiety, emotion regulation, and stress recovery. Those with vulnerable profiles did not show significant improvements in any outcome. Limitations of this study include the relatively small sample size and potential biases associated with participant dropout. Brief app-based mental interventions may be more beneficial for those with greater levels of stress resiliency and plasticity in response to stressors. More vulnerable individuals might require more intense and personalized intervention formats.

Participant recruitment and attrition in surgical randomised trials with placebo controls versus non-operative controls: a meta-epidemiological study and meta-analysis

ObjectiveTo compare differences in recruitment and attrition between placebo control randomised trials of surgery, and trials of the same surgical interventions and conditions that used non-operative (non-placebo) controls.DesignMeta-epidemiological study.Data sourcesRandomised...

Comparing the effectiveness of computer-aided design/computer-aided manufacturing (CAD/CAM) of insoles manufactured from foam box cast versus direct scans on patient-reported outcome measures: a protocol for a double-blinded, randomised controlled trial

IntroductionCustom insoles are a routine treatment for many foot pathologies, and the use of computer-aided design and computer-aided manufacturing (CAD/CAM) is well established within clinical practice in the UK. The...

Feasibility study of rehabilitation for cardiac patients aided by an artificial intelligence web-based programme: a randomised controlled trial (RECAP trial)—a study protocol

IntroductionCardiac rehabilitation (CR) delivered by rehabilitation specialists in a healthcare setting is effective in improving functional capacity and reducing readmission rates after cardiac surgery. It is also associated with a...

Attrition from longitudinal ageing studies and performance across domains of cognitive functioning: an individual participant data meta-analysis

ObjectivesThis paper examined the magnitude of differences in performance across domains of cognitive functioning between participants who attrited from studies and those who did not, using data from longitudinal ageing...

A pilot study of a new app based on self-compassion for the prevention and promotion of mental health among Brazilian college students.

Epidemiological data suggest substantial issues on the mental health of university students worldwide. Self-compassion is associated with lower rates of psychological distress and better positive mental health. Thus, we have developed a app-based intervention based on self-compassion principles targeting the prevention and promotion of mental health in college students. The current pilot study assessed adherence to intervention, preliminary mental health benefits, and satisfaction and acceptability with the app among Brazilian college students. The study employed a pre-experimental single-group design along with pre-test and post-test assessments (n = 23). A mixed methods approach was utilized to comprehensively assess the outcomes of the intervention. The overall adherence rate for the intervention was 37.87%, with 26.26% of participants successfully completing all modules. Among the 21 outcomes assessed, 15 exhibited statistically significant results. Notably, there was a substantial increase in self-compassion, demonstrating a large effect size (d = 1.15), and a moderate effect size reduction in stress (d = 0.62) and anxiety (d = 0.52). All satisfaction indicators for the intervention received scores above 7. The intervention was well-received by participants who completed it, although a potential barrier identified was the volume of text within the app and the need to adopt a more playful and concise format for the intervention. Despite a notable participant dropout, the adherence to intervention aligns with patterns observed in other online interventions conducted in real-world settings. The observed mental health benefits, high satisfaction levels, and positive acceptance underscore the rationale for pursuing a subsequent randomized clinical trial.

Spotivey: A web application for simplified use of the Spotify application programming interface in online questionnaire studies

Everyday music listening has become an important research topic during the last decades. However, self-reporting through questionnaire surveys, the received approach for studying individual music consumption, presents methodological challenges. The rise of mobile music streaming and open application programming interfaces introduces new opportunities to address these productively. Spotivey is a free research software that integrates music streaming provider API functionalities into online surveys and in this way allows to connect digital behavioral traces with self-reported questionnaire data. The current version effortlessly retrieves comprehensive information about respondents’ past music listening on Spotify while they fill an online survey. Through an informed consent procedure, General Date Protection Regulation compliance for this new form of digital data donation is ensured. Methodical challenges include participant dropout and the need for robust statistical analysis methods. Planned future enhancements encompass expanding application programming interfaces support, enriching retrieved data with information from other music databases, and compatibility with diverse online survey design systems.

The application of target trials with longitudinal targeted maximum likelihood estimation to assess the effect of alcohol consumption in adolescence on depressive symptoms in adulthood.

Time-varying confounding is a common challenge for causal inference in observational studies with time-varying treatments, long follow-up periods, and participant dropout. Confounder adjustment using traditional approaches can be limited by data sparsity, weight instability, and computational issues. The Nicotine Dependence in Teens Study is a prospective cohort study, and we used data from 21 data collection cycles carried out from 1999 to 2008 among 1294 students recruited from 10 high schools in Montreal, Quebec, Canada, including follow-up into adulthood. Our aim in this study was to estimate associations of timing of alcohol initiation and cumulative duration of alcohol use with depression symptoms in adulthood. Based on the target trials framework, we defined intention-to-treat and as-treated parameters in a marginal structural model with sex as a potential effect-modifier. We then used the observational data to emulate the trials. For estimation, we used pooled longitudinal target maximum likelihood estimation, a plug-in estimator with double-robust and local efficiency properties. We describe strategies for dealing with high-dimensional potential drinking patterns and practical positivity violations due to a long follow-up time, including modifying the effect of interest by removing sparsely observed drinking patterns from the loss function and applying longitudinal modified treatment policies to represent the effect of discouraging drinking.

Protocol optimization and reducing dropout in online research.

Online research has advantages over in-person research; it's cost-efficient, scalable, and may increase diversity. Researchers collecting data online can assess protocol performance with classification models like a decision tree. However, challenges include attrition, lack of testing environment controls, technical limitations, and lack of face-to-face rapport and real time feedback. It is necessary to consider human factors of the teleresearch process from recruitment to data collection. Here we document the impact of protocol optimizations on social media engagement and retention between a pilot sample of Veterans (n = 26) and a post-optimization sample of both Veterans and civilians (n = 220) recruited from Facebook advertisements. Two-sided tests for equality of proportions were statistically significant: advertisement views leading to clicks increased by 23.8% [X2(1) = 130.3, p < 0.001] and completion of behavioral tasks increased by 31.2% [X2(1) = 20.74, p < 0.001]. However, a proportion of participants dropped out of the study before completion for both samples. To explore why, a C5.0 decision tree was used to find features that classify participant dropout. The features chosen by the algorithm were nicotine use (100%) and cannabis use (25.6%). However, for those completing the study, data quality of cognitive performance was similar for users and nonusers. Rather than determining eligibility, participants who endorse using nicotine, or both nicotine and cannabis, may have individual differences that require support in online protocols to reduce drop out, such as extra breaks. An introduction page that humanizes participants' lifestyle habits as a naturalistic benefit of remote research may also be helpful. Strategies are discussed to increase engagement and improve data quality. The findings have implications for the feasibility of conducting remote research, an increasingly popular approach that has distinct challenges compared to in-person studies.

A randomized controlled trial comparing the efficacy of nifedipine and enalapril in the postpartum period

Postpartum hypertension is a common medical complication of pregnancy and is associated with increased healthcare use, including unplanned interactions with the medical system and readmission, which can add significant stress to both a newly postpartum patient and the medical care delivery system. We currently do not know what the best antihypertensive treatment for postpartum hypertension is and tend to use antihypertensives commonly used during pregnancy. However, the mechanism of action of angiotensin-converting enzyme inhibitors may be well suited for the pathophysiology of hypertension in the postpartum period and may help to provide better control of hypertension and, in turn, decrease healthcare use. This study aimed to determine if enalapril is superior to nifedipine in preventing prolonged hospitalizations, unplanned medical visits, and/or readmission among women with postpartum hypertension. We performed an open-label, randomized controlled trial(ClinicalTrials.gov registered: NCT04236258)in which patients≥18 years with chronic hypertension, gestational hypertension, or preeclampsia were recruited to receive either 10 mg enalapril daily or 30 mg extended-release nifedipine daily as an initial antihypertensive agent in the period from delivery to 6 weeks postpartum. Recruitment occurred at a tertiary academic hospital from January 2020 to February 2021. Exclusion criteria included being on an antihypertensive when pregnancy started or requiring≥2 daily antihypertensives during pregnancy. The antihypertensive regimen was managed by the participants' obstetrical provider after the initial randomization. The primary outcome was a composite of prolonged hospitalization, unplanned clinic visits, triage visits, and/or readmission. A total of 40 patients in each arm were needed to detect a decrease in the primary outcome rate from 70% to 40% (α=0.05; power 0.80). Analyses were performed based on the intention-to-treat principal, and each arm was oversampled because of the risk for participant dropout. A total of 47 patients were randomized to each arm. Aside from the mode of delivery and twin gestation, the maternal demographics were similar between the 2 groups. The primary outcome occurred in 31 of 47 patients (66%) randomized to the nifedipine group and in 30 of 47 (64%) randomized to the enalapril group (P=.83). There was no significant difference in the primary outcome after controlling for mode of delivery and twin gestation. More patients in the enalapril arm had a second antihypertensive added during their primary hospitalization (16 vs 6) and more patients in the nifedipine arm were still on their antihypertensive at 2 weeks postpartum (42 vs 36). There were no adverse events in either group. Enalapril was not superior to nifedipine when used as an initial antihypertensive in the immediate postpartum period in terms of decreasing healthcare use.

Evaluation of the "Shifting Weight using Intermittent Fasting in night-shift workers" weight loss interventions: a mixed-methods protocol.

Shift workers are at a greater risk for obesity-related conditions. The impacts of working at night presents a challenge for designing effective dietary weight-loss interventions for this population group. The Shifting Weight using Intermittent Fasting in night-shift workers (SWIFt) study is a world-first, randomized controlled trial that compares three weight-loss interventions. While the trial will evaluate the effectiveness of weight-loss outcomes, this mixed-methods evaluation aims to explore for who weight-loss outcomes are achieved and what factors (intervention features, individual, social, organisational and wider environmental) contribute to this. A convergent, mixed-methods evaluation design was chosen where quantitative and qualitative data collection occurs concurrently, analyzed separately, and converged in a final synthesis. Quantitative measures include participant engagement assessed via: dietary consult attendance, fulfillment of dietary goals, dietary energy intake, adherence to self-monitoring, and rates for participant drop-out; analyzed for frequency and proportions. Regression models will determine associations between engagement measures, participant characteristics (sex, age, ethnicity, occupation, shift type, night-shifts per week, years in night shift), intervention group, and weight change. Qualitative measures include semi-structured interviews with participants at baseline, 24-weeks, and 18-months, and fortnightly audio-diaries during the 24-week intervention. Interviews/diaries will be transcribed verbatim and analyzed using five-step thematic framework analysis in NVivo. Results from the quantitative and qualitative data will be integrated via table and narrative form to interrogate the validity of conclusions. The SWIFt study is a world-first trial that compares the effectiveness of three weight-loss interventions for night shift workers. This mixed-methods evaluation aims to further explore the effectiveness of the interventions. The evaluation will determine for who the SWIFt interventions work best for, what intervention features are important, and what external factors need to be addressed to strengthen an approach. The findings will be useful for tailoring future scalability of dietary weight-loss interventions for night-shift workers.Clinical trial registration: This evaluation is based on the SWIFt trial registered with the Australian New Zealand Clinical Trials Registry [ACTRN 12619001035112].

A new acquisition protocol for conducting studies with children: The science camp research experience.

In the last 50 years, the study of brain development has brought major discoveries to education and medicine, changing the lives of millions of children and families. However, collecting behavioral and neurophysiological data from children has specific challenges, such as high rates of data loss and participant dropout. We have developed a science camp method to collect data from children using the benefits of positive peer interactions and interactive and engaging activities, to allow researchers to better collect data repeatedly and reliably from groups of children. A key advantage of this approach is that by increasing participant engagement, attention is also increased, thereby increasing data quality, reducing data loss, and lowering attrition rates. This protocol describes the step-by-step procedure for facilitation of a science camp, including behavioral, electrophysiological, and participatory engagement activities. As this method is robust but also flexible, we anticipate that it can also be applied to different demographics and research needs.

Effectiveness of an app-based intervention to improve well-being through cultivating positive thinking and positive emotions in an adult sample: study protocol for a randomized controlled trial.

Interventions to promote health and well-being based on the construction of psychological resources can positively impact the daily life of users and foster human flourishing. Nowadays, mobile health represents a safe way to support health research and implement evidence-based psychological interventions. The present study aims to evaluate the effectiveness of a mobile app-based intervention program (OneUS) designed to cultivate positive emotions and positive thinking to improve overall well-being. The study is designed as a randomized controlled trial. Two hundred participants will be randomly assigned to either a mobile health intervention condition (OneUS App) or an active control condition. The intervention consists of a program to cultivate positive emotions and positive thoughts. The active control intervention will comprise a set of mental imagery exercises and daily routine recording. The primary outcome comprises optimal well-being assessed using the multidimensional PERMA-Profiler scale. The sample will include adult people from the general population, who will be assessed at 8 time points: baseline (t1), intervention (t2, t3, t4, t5, t6) post-intervention (t7) and 3-month follow-up (t8). Mobile apps seem to be promising tools to promote health and well-being. This study will evaluate the effectiveness of a mobile app (OneUS) aiming to cultivate positive emotions and positive thinking to improve well-being. The main strength of this study is the development of an evidence-based mobile health app, based on intentional mental training, to promote well-being. The limitations of this study relate to potential participant drop-out and the non-generalizability of the results to clinical populations. https://ensaiosclinicos.gov.br/rg/RBR-43hpwqk, Identifier RBR-43hpwqk.

Clinical and cost effectiveness of a system for turning and positioning intensive care unit patients, when compared to usual care turning and positioning devices, for the prevention of hospital-acquired pressure injuries. A randomised controlled trial.

Pressure injuries affect 13.1% to 45.5% of patients in the intensive care unit and lead to pain and discomfort for patients, burden on healthcare providers, and unnecessary cost to the health system. Turning and positioning systems offer improvements on usual care devices, however the evidence of the effectiveness of such systems is still emerging. We conducted an investigator initiated, prospective, single centre, two group, non-blinded, randomised controlled trial to determine the effectiveness of a system for turning and positioning intensive care unit patients, when compared to usual care turning and positioning devices, for preventing PIs. The trial was prematurely discontinued after enrolment of 78 participants due to COVID-19 pandemic related challenges and lower than expected enrolment rate. The study groups were comparable on baseline characteristics and adherence to the interventions was high. Four participants developed a PI (in the sacral, ischial tuberosity or buttock region), n = 2 each in the intervention and control group. Each participant developed one PI. As the trial is underpowered, these findings do not provide an indication of the clinical effectiveness of the interventions. There was no participant drop-out or withdrawal and there were no adverse events, device deficiencies, or adverse device effects identified or reported. The results of our study (in particular those pertaining to enrolment, intervention adherence and safety) provide considerations for future trials that seek to investigate how to prevent PIs among ICU patients.

Identifying and Categorizing Adverse Events in Trials of Digital Mental Health Interventions: Narrative Scoping Review of Trials in the International Standard Randomized Controlled Trial Number Registry.

To contextualize the benefits of an intervention, it is important that adverse events (AEs) are reported. This is potentially difficult in trials of digital mental health interventions, where delivery may be remote and the mechanisms of actions less understood. We aimed to explore the reporting of AEs in randomized controlled trials of digital mental health interventions. The International Standard Randomized Controlled Trial Number database was searched for trials registered before May 2022. Using advanced search filters, we identified 2546 trials in the category of mental and behavioral disorders. These trials were independently reviewed by 2 researchers against the eligibility criteria. Trials were included where digital mental health interventions for participants with a mental health disorder were evaluated through a completed randomized controlled trial (protocol and primary results publication published). Published protocols and primary results publications were then retrieved. Data were extracted independently by 3 researchers, with discussion to reach consensus when required. Twenty-three trials met the eligibility criteria, of which 16 (69%) included a statement on AEs within a publication, but only 6 (26%) reported AEs within their primary results publication. Seriousness was referred to by 6 trials, relatedness by 4, and expectedness by 2. More interventions delivered with human support (9/11, 82%) than those with only remote or no support (6/12, 50%) included a statement on AEs, but they did not report more AEs. Several reasons for participant dropout were identified by trials that did not report AEs, of which some were identifiable or related to AEs, including serious AEs. There is significant variation in the reporting of AEs in trials of digital mental health interventions. This variation may reflect limited reporting processes and difficulty recognizing AEs related to digital mental health interventions. There is a need to develop guidelines specifically for these trials to improve future reporting.