Participant Dropout Research Articles

Identification of dropout predictors to a community-based physical activity programme that uses motivational interviewing.

Participant dropout reduces intervention effectiveness. Predicting dropout has been investigated for Exercise Referral Schemes, but not physical activity (PA) interventions with Motivational Interviewing (MI). Data from attendees (n = 619) to a community-based PA programme utilizing MI techniques were analysed using a chi-squared test to determine dropout and attendance group differences. Binary logistic regression investigated the likelihood of dropout before 12 weeks. A total of 44.7% of participants dropped out, with statistical (P < 0.05) differences between groups for age, PA and disability. Regression for each variable showed participants aged 61-70 years (OR = 0.28, CI = 0.09-0.79; P = 0.018), >70 years (OR = 0.30, CI = 0.09-0.90; P = 0.036), and high PA (OR = 0.40, CI = 0.20-0.75; P = 0.006) reduced dropout likelihood. Endocrine system disorders (OR = 4.24, CI = 1.19-19.43; P = 0.036) and musculoskeletal disorders (OR = 3.14, CI = 1.84-5.45; P < 0.001) increased dropout likelihood. Significant variables were combined in a single regression model. Dropout significantly reduced for 61-70 years old (OR = 0.31, CI = 0.10-0.90; P = 0.035), and high PA (OR = 0.39, CI = 0.19-0.76; P = 0.008). Musculoskeletal disorders increased dropout (OR = 2.67, CI = 1.53-4.75; P < 0.001). Age, PA and disability type significantly influence dropout at 12 weeks. These are the first results specific to MI based programmes indicating the inclusion of MI and highlighting the need for further research.

Reciprocal relationships between self-efficacy, outcome satisfaction, and attendance at an exercise programme.

The objectives of this study were to (i) investigate directional influences of self-efficacy, outcome satisfaction, and attendance during an exercise programme and (ii) examine the predictive capabilities of self-efficacy and outcome satisfaction on participant dropout. Adults aged 35-65years were recruited to a 12-month exercise programme. Self-efficacy was collected at baseline, three, six, nine, and 12months, and outcome satisfaction at the same time-points except baseline. Cross-lagged panel analyses and logistic regression analyses were conducted to examine the primary and secondary objectives, respectively. Coping and scheduling self-efficacy had stronger reciprocal relationships with outcome satisfaction than task self-efficacy, although the strength of these relationships varied across time. Initially, task self-efficacy predicted programme attendance. Midway through the programme, outcome satisfaction predicted attendance, and by the end of the programme, coping self-efficacy was the strongest predictor of attendance. Self-efficacy and outcome satisfaction did not predict programme dropout. The results support the reciprocal relationship between outcome satisfaction and scheduling and coping self-efficacy and highlight the importance of sequentially targeting different beliefs and skills to facilitate successful initiation and maintenance of exercise behaviour. Statement of contribution What is already known on this subject? Self-efficacy and outcome satisfaction are related to exercise behaviour. The relationship between self-efficacy and outcome satisfaction are typically considered unidirectional. The longitudinal relationships among self-efficacy, outcome satisfaction, and physical activity participation are unclear. What does this study add? Outcome satisfaction had reciprocal relationships with both coping and scheduling self-efficacy for exercise. The importance of self-efficacy and outcome satisfaction to exercise attendance changes over time. Task self-efficacy was the strongest predictor of initial programme attendance. Midway through the programme, outcome satisfaction and task self-efficacy were the strongest predictors of attendance, and by the end of the programme, coping self-efficacy was the strongest predictor.

Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke.

Electromechanical and robot-assisted arm training devices are used in rehabilitation, and may help to improve arm function after stroke. To assess the effectiveness of electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength in people after stroke. We also assessed the acceptability and safety of the therapy. We searched the Cochrane Stroke Group's Trials Register (last searched January 2018), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2018, Issue 1), MEDLINE (1950 to January 2018), Embase (1980 to January 2018), CINAHL (1982 to January 2018), AMED (1985 to January 2018), SPORTDiscus (1949 to January 2018), PEDro (searched February 2018), Compendex (1972 to January 2018), and Inspec (1969 to January 2018). We also handsearched relevant conference proceedings, searched trials and research registers, checked reference lists, and contacted trialists, experts, and researchers in our field, as well as manufacturers of commercial devices. Randomised controlled trials comparing electromechanical and robot-assisted arm training for recovery of arm function with other rehabilitation or placebo interventions, or no treatment, for people after stroke. Two review authors independently selected trials for inclusion, assessed trial quality and risk of bias, used the GRADE approach to assess the quality of the body of evidence, and extracted data. We contacted trialists for additional information. We analysed the results as standardised mean differences (SMDs) for continuous variables and risk differences (RDs) for dichotomous variables. We included 45 trials (involving 1619 participants) in this update of our review. Electromechanical and robot-assisted arm training improved activities of daily living scores (SMD 0.31, 95% confidence interval (CI) 0.09 to 0.52, P = 0.0005; I² = 59%; 24 studies, 957 participants, high-quality evidence), arm function (SMD 0.32, 95% CI 0.18 to 0.46, P < 0.0001, I² = 36%, 41 studies, 1452 participants, high-quality evidence), and arm muscle strength (SMD 0.46, 95% CI 0.16 to 0.77, P = 0.003, I² = 76%, 23 studies, 826 participants, high-quality evidence). Electromechanical and robot-assisted arm training did not increase the risk of participant dropout (RD 0.00, 95% CI -0.02 to 0.02, P = 0.93, I² = 0%, 45 studies, 1619 participants, high-quality evidence), and adverse events were rare. People who receive electromechanical and robot-assisted arm training after stroke might improve their activities of daily living, arm function, and arm muscle strength. However, the results must be interpreted with caution although the quality of the evidence was high, because there were variations between the trials in: the intensity, duration, and amount of training; type of treatment; participant characteristics; and measurements used.

Perceptions of Response Burden Associated with Completion of Patient-Reported Outcome Assessments in Oncology

BackgroundPatient response burden is often raised as a human subject concern in consideration of the length or complexity of patient-reported outcome (PRO) instruments used in oncology. ObjectivesTo quantify patient response burden and identify its predictive factors. MethodsData were collected presurgically during a prospective trial that used a comprehensive symptom and health-related quality-of-life (HRQOL) PRO assessment. A subset of patients also completed HRQOL interviews. Response burden was captured using an internally developed six-item instrument. Demographic and clinical characteristics as well as HRQOL scores were examined as potential predictors using hierarchical regression. Response burden was used to predict participant dropout at the first follow-up interval. ResultsA total of 275 patients (mean age 67.5 years; 23.6% female) completed surveys (n = 126) or surveys in addition to interviews (n = 149). Patients experienced low response burden (mean 12.19 ± 11.65). Repetitive questions were identified by 60 patients (21.8%), whereas 31.6% indicated that additional information should be gathered; 35 patients (12.7%) identified repetitive questions and expressed a desire for additional items. Low self-reported cognitive function was a significant predictor of higher response burden (β = −0.20; t(270) = −3.38; P = 0.01; model-adjusted R2 = 0.04). Response burden was not a significant predictor of study dropout. ConclusionsDespite completing a large battery of PRO measures and interviews, patients reported minimal response burden, with nearly one-third expressing that more questions should have been asked. Patients with lower cognitive function are more likely to report higher response burden when completing PRO measures. Further examination of patient characteristics related to response burden may reveal useful pathways for tailoring patient-centered interventions.

Current Theories and Clinical Trial Evidence for Limiting Human Abdominal Aortic Aneurysm Growth.

Abdominal aortic aneurysm (AAA) refers to localized dilation of abdominal aorta. AAA is largely asymptomatic, but aneurysmal rupture results in a high mortality rate. AAA with a diameter greater than 55 mm carries a high risk of rupture. There are currently no known medical treatments effective in limiting the growth of small AAA. To review the current status of and challenges faced in limiting AAA growth. Data from human investigations and animal model studies were summarized. In particular, the ClinicalTrials.gov website was searched for details of ongoing or completed studies related to AAA growth. We searched the key words 'abdominal aortic aneurysm' and 'drugs' to identify potential target drugs for slowing or stopping AAA growth. These clinical trials involve a number of challenges, including demonstrating the design of the trial, minimizing the participant dropout rate, and developing accurate outcome assessments during the trials. A number of clinical trials have concentrated on pharmaceutical intervention (such as angiotensin- converting enzyme inhibitors, beta-blockers, statins, and antibiotics) that could be effective for AAA patients in delaying or reversing aneurysm expansion and postponing the endpoint for elective surgical repair. Further randomized, controlled, clinical trials are required to develop effective nonsurgical therapies for AAA.

Injectable local anaesthetic agents for dental anaesthesia.

Injectable local anaesthetic agents for dental anaesthesia.

Detecting small-study effects and funnel plot asymmetry in meta-analysis of survival data: A comparison of new and existing tests.

Small‐study effects are a common threat in systematic reviews and may indicate publication bias. Their existence is often verified by visual inspection of the funnel plot. Formal tests to assess the presence of funnel plot asymmetry typically estimate the association between the reported effect size and their standard error, the total sample size, or the inverse of the total sample size. In this paper, we demonstrate that the application of these tests may be less appropriate in meta‐analysis of survival data, where censoring influences statistical significance of the hazard ratio. We subsequently propose 2 new tests that are based on the total number of observed events and adopt a multiplicative variance component. We compare the performance of the various funnel plot asymmetry tests in an extensive simulation study where we varied the true hazard ratio (0.5 to 1), the number of published trials (N=10 to 100), the degree of censoring within trials (0% to 90%), and the mechanism leading to participant dropout (noninformative versus informative). Results demonstrate that previous well‐known tests for detecting funnel plot asymmetry suffer from low power or excessive type‐I error rates in meta‐analysis of survival data, particularly when trials are affected by participant dropout. Because our novel test (adopting estimates of the asymptotic precision as study weights) yields reasonable power and maintains appropriate type‐I error rates, we recommend its use to evaluate funnel plot asymmetry in meta‐analysis of survival data. The use of funnel plot asymmetry tests should, however, be avoided when there are few trials available for any meta‐analysis.

The Fear Reduction Exercised Early (FREE) approach to low back pain: study protocol for a randomised controlled trial

BackgroundLow back pain (LBP) is a major health issue associated with considerable health loss and societal costs. General practitioners (GPs) play an important role in the management of LBP; however, GP care has not been shown to be the most cost-effective approach unless exercise and behavioural counselling are added to usual care. The Fear Reduction Exercised Early (FREE) approach to LBP has been developed to assist GPs to manage LBP by empowering exploration and management of psychosocial barriers to recovery and provision of evidence-based care and information. The aim of the Low Back Pain in General Practice (LBPinGP) trial is to explore whether patients with LBP who receive care from GPs trained in the FREE approach have better outcomes than those who receive usual care.Methods/designThis is a cluster randomised controlled superiority trial comparing the FREE approach with usual care for LBP management with investigator-blinded assessment of outcomes. GPs will be recruited and then cluster randomised (in practice groups) to the intervention or control arm. Intervention arm GPs will receive training in the FREE approach, and control arm GPs will continue to practice as usual. Patients presenting to their GP with a primary complaint of LBP will be allocated on the basis of allocation of the GP they consult. We aim to recruit 60 GPs and 275 patients (assuming patients are recruited from 75% of GPs and an average of 5 patients per GP complete the study, accounting for 20% patient participant dropout). Patient participants and the trial statistician will be blind to group allocation throughout the study. Analyses will be undertaken on an intention-to-treat basis. The primary outcome will be back-related functional impairment 6 months post-initial LBP consultation (interim data at 2 weeks, 6 weeks and 3 months), measured with the Roland-Morris Disability Questionnaire. Secondary patient outcomes include pain, satisfaction, quality of life, days off from work and costs of care. Secondary GP outcomes include beliefs about pain and impairment, GP confidence, and actual and reported clinical behaviour. Health economic and process evaluations will be conducted.DiscussionIn the LBPinGP trial, we will investigate providing an intervention during the first interaction a person with back pain has with their GP. Because the FREE approach is used within a normal GP consultation, if effective, it may be a cost-effective means of improving LBP care.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12616000888460. Registered on 6 July 2016.

WITHDRAWN: Intermittent catheterisation for long-term bladder management.

Intermittent catheterisation is a commonly recommended procedure for people with incomplete bladder emptying. There are now several designs of intermittent catheter (e.g. different lengths, 'ready to use' presentation) with different materials (e.g. PVC-free) and coatings (e.g. hydrophilic). The most frequent complication of intermittent catheterisation is urinary tract infection (UTI), but satisfaction, preference and ease of use are also important to users. It is unclear which catheter designs, techniques or strategies affect the incidence of UTI, which are preferable to users and which are most cost effective. To compare one type of catheter design versus another, one type of catheter material versus another, aseptic catheterisation technique versus clean technique, single-use (sterile) catheters versus multiple-use (clean) catheters, self-catheterisation versus catheterisation by others and any other strategies designed to reduce UTI and other complications or improve user-reported outcomes (user satisfaction, preference, ease of use) and cost effectiveness in adults and children using intermittent catheterisation for incomplete bladder emptying. We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, and handsearching of journals and conference proceedings (searched 30 September 2013), the reference lists of relevant articles and conference proceedings, and we attempted to contact other investigators for unpublished data or for clarification. Randomised controlled trials (RCTs) or randomised cross-over trials comparing at least two different catheter designs, catheterisation techniques or strategies. Two review authors assessed the methodological quality of trials and abstracted data. For dichotomous variables, risk ratios and 95% confidence intervals were derived for each outcome where possible. For continuous variables, mean differences and 95% confidence intervals were calculated for each outcome. Because of trial heterogeneity, it was not always possible to combine data to give an overall estimate of treatment effect. Thirty-one trials met the inclusion criteria, including 13 RCTs and 18 cross-over trials. Most were small (less than 60 participants completed), although five trials had more than 100 participants. There was considerable variation in length of follow-up and definitions of UTI. Participant dropout was a problem for several trials, particularly where there was long-term follow-up to measure incidence of UTI. Fifteen trials were more than 10 years old and focused mainly on comparing different catheterisation techniques (e.g. single versus multiple-use) on clinical outcomes whereas, several more recent trials have focused on comparing different types of catheter designs or materials, especially coatings, and user preference. It was not possible to combine data from some trials owing to variations in the catheters tested and in particular the catheter coatings. Where there were data, confidence intervals around estimates were wide and hence clinically important differences in UTI and other outcomes could neither be identified nor reliably ruled out. No study assessed cost-effectiveness. Despite a total of 31 trials, there is still no convincing evidence that the incidence of UTI is affected by use of aseptic or clean technique, coated or uncoated catheters, single (sterile) or multiple-use (clean) catheters, self-catheterisation or catheterisation by others, or by any other strategy. Results from user-reported outcomes varied. The current research evidence is weak and design issues are significant. More well-designed trials are strongly recommended. Such trials should include analysis of cost-effectiveness because there are likely to be substantial differences associated with the use of different catheter designs, catheterisation techniques and strategies.

Conducting interactive experiments online

Online labor markets provide new opportunities for behavioral research, but conducting economic experiments online raises important methodological challenges. This particularly holds for interactive designs. In this paper, we provide a methodological discussion of the similarities and differences between interactive experiments conducted in the laboratory and online. To this end, we conduct a repeated public goods experiment with and without punishment using samples from the laboratory and the online platform Amazon Mechanical Turk. We chose to replicate this experiment because it is long and logistically complex. It therefore provides a good case study for discussing the methodological and practical challenges of online interactive experimentation. We find that basic behavioral patterns of cooperation and punishment in the laboratory are replicable online. The most important challenge of online interactive experiments is participant dropout. We discuss measures for reducing dropout and show that, for our case study, dropouts are exogenous to the experiment. We conclude that data quality for interactive experiments via the Internet is adequate and reliable, making online interactive experimentation a potentially valuable complement to laboratory studies.

Parent-based diagnosis of ADHD is as accurate as a teacher-based diagnosis of ADHD

ABSTRACTObjective: To review the literature evaluating the psychometric properties of parent and teacher informants relative to a gold-standard ADHD diagnosis in pediatric populations.Method: We included studies that included both a parent and teacher informant, a gold-standard diagnosis, and diagnostic accuracy metrics. Potential confounds were evaluated. We also assessed the ‘OR’ and the ‘AND’ rules for combining informant reports.Results: Eight articles met inclusion criteria. The diagnostic accuracy for predicting gold standard ADHD diagnoses did not differ between parents and teachers. Sample size, sample type, participant drop-out, participant age, participant gender, geographic area of the study, and date of study publication were assessed as potential confounds.Conclusion: Parent and teachers both yielded moderate to good diagnostic accuracy for ADHD diagnoses. Parent reports were statistically indistinguishable from those of teachers. The predictive features of the ‘OR’ and ‘AND’ rules are useful in evaluating approaches to better integrating information from these informants.

13: Evaluating ureteral patency in the post-indigo carmine era: A randomized controlled trial

Many gynecologic, urologic and pelvic reconstructive surgeries require accurate intra-operative evaluation of ureteral patency. The objective of this study is to compare surgeon satisfaction with four methods of evaluating ureteral patency at the time of cystoscopy: phenazopyridine, sodium fluorescein, mannitol, and normal saline. We conducted a randomized controlled trial of the method used to evaluate ureteral patency during cystoscopy at time of benign gynecologic or pelvic reconstructive surgery. Subjects were randomized to 200 mg oral phenazopyridine, 25 mg sodium fluorescein intravenously, mannitol bladder distention, or normal saline bladder distention during cystoscopy to evaluate ureteral patency. The primary outcome was surgeon satisfaction with the method, which was assessed via a 10 cm Visual Analog Scale (VAS). A priori sample size of 137 participants was planned to detect a 3 cm difference in the VAS scale with 80% power and a 2-tailed alpha of 0.05, including 10% added for participant dropout. Demographic and operative information, including time to confidence in the ureteral jets was collected. Adverse events were followed for at least 6 weeks after the surgical procedure. Two hundred nine patients were screened for eligibility, 193 met inclusion criteria, and 140 were consented and enrolled in the study. One hundred thirty subjects were randomized and evaluated according to intention-to-treat into four groups: phenazopyridine (n = 33), sodium fluorescein (n = 32), mannitol (n = 32), and normal saline (n = 33). Demographics were similar between groups with mean/standard deviation age of 50 years (12) and BMI 29 (7), and median/range parity 2 (0, 8). Forty-two percent were Hispanic, 31% white, 19% African American, 2% Asian, and 6% unknown/other. Indications for surgery were similar across groups and included AUB/fibroids (48%), prolapse (28%), incontinence (12%), and microhematuria (4%). Type of surgery did not differ across groups and included 55% hysterectomy, 42% pelvic reconstruction, and 26% incontinence surgery. With regard to the primary outcome, mannitol was noted to be the most satisfactory method to physicians for assessing ureteral patency (p < 0.001). Mannitol was also the easiest method to use and the agent that provided the clearest and most definitive visualization of the ureteral jets, bladder mucosa and urethra (all p < 0.001). Surgery length, cystoscopy length, and time to confidence in ureteral jets were not different between groups (all p > 0.05). During the 111 day median follow-up, there was no significant difference in adverse events noted among the groups, including urinary tract infections (all p > 0.05). The use of mannitol during cystoscopy to assess ureteral patency provided surgeons with the most overall satisfaction, ease of use, and superior visualization without impacting surgery or cystoscopy times. There were no differences in adverse events, including urinary tract infections.

Attrition during a randomized controlled trial of reduced nicotine content cigarettes as a proxy for understanding acceptability of nicotine product standards.

To determine (1) if nicotine content affects study attrition-a potential behavioral measure of acceptability-in a trial that required compliance with three levels of reduced nicotine content (RNC) cigarettes, and (2) if attrition is associated with subjective and behavioral responses to RNC cigarettes. Secondary analysis of a 35-day, parallel-design, open-label, randomized controlled trial. After a 5-day baseline period, participants were randomized to smoke for three 10-day periods: their preferred brand (control group) or RNC cigarettes with three nicotine levels in a within-subject stepdown (one group: high-moderate-low) or non-stepdown (five groups: high-low-moderate, low-moderate-high, low-high-moderate, moderate-low-high, moderate-high-low) fashion. A single site in Philadelphia, PA, USA. A total of 246 non-treatment-seeking daily smokers [mean age=39.52, cigarettes per day (CPD)=20.95, 68.3% white] were recruited from October 2007 to June 2013. The primary outcome was attrition. Key predictors were nicotine content transition and study period. Exploratory predictors were taste and strength subjective ratings, total puff volume and carbon monoxide (CO) boost. Covariates included: age, gender, race, education and nicotine dependence. Overall attrition was 31.3% (n=77): 24.1% of the control and 25.0% of the stepdown RNC cigarette groups dropped out versus 44.6% of non-stepdown groups (P=0.006). Compared with controls, attrition odds were 4.5 and 4.7 times greater among smokers transitioning from preferred and the highest RNC cigarettes to the lowest RNC cigarettes, respectively (P=0.001 and 0.003). Providing more favorable initial taste ratings of study cigarettes decreased attrition odds by 2% (P=0.012). The majority of participants completed a 35-day trial of varying levels of reduced nicotine content cigarettes. Participant dropout was greater for cigarettes with lower nicotine content and less in smokers reporting more favorable subjective ratings of the cigarettes.

Conducting Interactive Experiments Online

Online labor markets provide new opportunities for behavioral research, but conducting economic experiments online raises important methodological challenges. This particularly holds for interactive designs. In this paper, we provide a methodological discussion of the similarities and differences between interactive experiments conducted in the laboratory and online. To this end, we conduct a repeated public goods experiment with and without punishment using samples from the laboratory and the online platform Amazon Mechanical Turk. We chose to replicate this experiment because it is long and logistically complex. It therefore provides a good case study for discussing the methodological and practical challenges of online interactive experimentation. We find that basic behavioral patterns of cooperation and punishment in the laboratory are replicable online. The most important challenge of online interactive experiments is participant dropout. We discuss measures for reducing dropout and show that, for our case study, dropouts are exogenous to the experiment. We conclude that data quality for interactive experiments via the Internet is adequate and reliable, making online interactive experimentation a valuable complement to laboratory studies.

Menstruation and the Cycle of Poverty: A Cluster Quasi-Randomised Control Trial of Sanitary Pad and Puberty Education Provision in Uganda.

BackgroundPoor menstrual knowledge and access to sanitary products have been proposed as barriers to menstrual health and school attendance. In response, interventions targeting these needs have seen increasing implementation in public and private sectors. However, there has been limited assessment of their effectiveness.ObjectivesAssess the impact of providing reusable sanitary pads and puberty education on girls’ school attendance and psychosocial wellbeing outcomes.MethodsA cluster quasi-randomised controlled trial was conducted across 8 schools, including 1124 girls, in rural Uganda. Schools were allocated to one of four conditions: the provision of puberty education alone; reusable sanitary pads alone; puberty education and reusable sanitary pads; and a control (no intervention). The primary outcome was school attendance. Secondary outcomes reflected psychosocial wellbeing.ResultsAt follow-up, school attendance had worsened for girls across all conditions. Per-protocol analysis revealed that this decline was significantly greater for those in the control condition d = 0.52 (95%CI 0.26–0.77), with those in control schools having a 17.1% (95%CI: 8.7–25.5) greater drop in attendance than those in any intervention school. There were no differences between the intervention conditions. High rates of school drop-out and transfer meant the trial suffered from substantial participant drop-out. Intention-to-treat analyses using two different imputation strategies were consistent with the main results, with mean differences of 5.2% attendance in best-case and 24.5% in worst-case imputations. Results were robust to adjustments for clustering. There was no impact of the interventions on girls’ self-reported shame or insecurity during menstruation.ConclusionResults of the trial support the hypothesised positive impact of providing sanitary pads or puberty education for girls’ school attendance in a developing country context. Findings must be interpreted with caution in light of poor participant retention, intervention fidelity, and the attendance measures used.Trial RegistrationPan African Clinical Trials Registry PACTR201503001044408

Retrospective cohort study of the South Tyneside Exercise Referral Scheme 2009-14: predictors of dropout and barriers to adherence.

Exercise Referral Schemes (ERS) are a prevalent method of increasing physical activity levels. However, they suffer from participant dropout and research predicting dropout or barriers to adherence are limited. This study aimed to focus upon the effect of referral characteristics on dropout, dropout predictors and whether self-reported barriers to exercise predict dropout. ERS data from 2009 to 2014 were retrieved for analysis. Chi-squared and t-tests were used to investigate differences between referral characteristics, and logistic regression used to investigate dropout predictors. Of 6894 participants, 37.8% (n=2608) dropped out within 6 weeks and 50.03% (n=3449) by the final 12th week. More males adhered (P<0.001) with dropouts being significantly younger (P<0.001). Dropout predictors were smoking (OR=1.58, 95% CI: 1.29-1.93) or being a Tier 3 referral (OR=1.47, 95% CI: 1.25-1.73). Increasing age (OR=0.98, 95% CI: 0.98-0.99), drinking alcohol (OR=0.82, 95% CI: 0.71-0.95), secondary care referrals (OR=0.68, 95% CI: 0.52-0.90), having a lack of motivation (OR=0.81, 95% CI: 0.69-0.95) or a lack of childcare (OR=0.69, 95% CI: 0.50-0.95) decreased the likelihood of dropout. ERS dropout continues to be problematic. Smoking and having moderate-high comorbidities predicted dropout. Increasing age and patient-reported barriers of a lack of time or childcare decreased dropout risk. The reasons for dropout require further investigation.

Methods for Evaluating Respondent Attrition in Web-Based Surveys.

BackgroundElectronic surveys are convenient, cost effective, and increasingly popular tools for collecting information. While the online platform allows researchers to recruit and enroll more participants, there is an increased risk of participant dropout in Web-based research. Often, these dropout trends are simply reported, adjusted for, or ignored altogether.ObjectiveTo propose a conceptual framework that analyzes respondent attrition and demonstrates the utility of these methods with existing survey data.MethodsFirst, we suggest visualization of attrition trends using bar charts and survival curves. Next, we propose a generalized linear mixed model (GLMM) to detect or confirm significant attrition points. Finally, we suggest applications of existing statistical methods to investigate the effect of internal survey characteristics and patient characteristics on dropout. In order to apply this framework, we conducted a case study; a seventeen-item Informed Decision-Making (IDM) module addressing how and why patients make decisions about cancer screening.ResultsUsing the framework, we were able to find significant attrition points at Questions 4, 6, 7, and 9, and were also able to identify participant responses and characteristics associated with dropout at these points and overall.ConclusionsWhen these methods were applied to survey data, significant attrition trends were revealed, both visually and empirically, that can inspire researchers to investigate the factors associated with survey dropout, address whether survey completion is associated with health outcomes, and compare attrition patterns between groups. The framework can be used to extract information beyond simple responses, can be useful during survey development, and can help determine the external validity of survey results.

Illness Management & Recovery (IMR) in the Netherlands; a naturalistic pilot study to explore the feasibility of a randomized controlled trial.

BackgroundIllness Management & Recovery (IMR) is a curriculum-based program for people with severe and persistent mental illness. To date, four randomized controlled trials (RCTs) have been published on it. As these produced mixed results, we conducted a pilot study to test the feasibility of conducting a new RCT in a Dutch psychiatric institute. Because our primary objective was to evaluate support for implementing IMR on a broader scale, we examined participant recruitment, client outcomes, and clients’ and clinicians’ satisfaction. Secondary objectives were to evaluate fidelity, trainers’ training and supervision, and to explore program duration, dropout, and client characteristics related to dropout. For reporting, we used the checklist for pilot studies adopted from the CONSORT Statement.MethodsThis program evaluation included a process-evaluation and an outcome evaluation with a One Group Pre-Posttest Design (N = 81). Interviews and internal reports were used to monitor participant numbers, program duration, dropout, and completers’ characteristics. Clients’ and clinicians’ satisfaction and provision of trainers’ training and supervision were assessed through interviews. Fidelity was assessed on the IMR Fidelity Scale; client outcomes were assessed on the IMR scale (client and clinician versions) and the Recovery Markers Questionnaire (RMQ).ResultsEighty-one participants were recruited of 167 people who were assessed for eligibility. Completers and clinicians were satisfied, and scores for completers improved significantly on the IMR scale (clinician version) (d = 0.84) and RMQ (d = 0.52), and not significantly on the IMR scale client version (d = 0.41). Mean fidelity was good, but three groups had only moderate fidelity. Our feasibility criterion for trainers’ education and supervision was partly attained. Dropout from treatment was 51 %; female participants and people who scored higher on both IMR-scales at baseline had a significantly lower chance of dropping out. The duration of IMR varied (M = 12.7 months, SD = 2.87).ConclusionsResults suggested that feasibility of conducting an RCT on IMR was good. Special attention is required to fidelity, IMR duration, trainers’ education and supervision, and dropout, especially of men. One study limitation was our inability to conduct follow-up measurements of non-completers.

Participant Recruitment and Engagement in Automated eHealth Trial Registration: Challenges and Opportunities for Recruiting Women Who Experience Violence.

BackgroundAutomated eHealth Web-based research trials offer people an accessible, confidential opportunity to engage in research that matters to them. eHealth trials may be particularly useful for sensitive issues when seeking health care may be accompanied by shame and mistrust. Yet little is known about people’s early engagement with eHealth trials, from recruitment to preintervention autoregistration processes. A recent randomized controlled trial that tested the effectiveness of an eHealth safety decision aid for New Zealand women in the general population who experienced intimate partner violence (isafe) provided the opportunity to examine recruitment and preintervention participant engagement with a fully automated Web-based registration process. The trial aimed to recruit 340 women within 24 months.ObjectiveThe objective of our study was to examine participant preintervention engagement and recruitment efficiency for the isafe trial, and to analyze dropout through the registration pathway, from recruitment to eligibility screening and consent, to completion of baseline measures.MethodsIn this case study, data collection sources included the trial recruitment log, Google Analytics reports, registration and program metadata, and costs. Analysis included a qualitative narrative of the recruitment experience and descriptive statistics of preintervention participant engagement and dropout rates. A Koyck model investigated the relationship between Web-based online marketing website advertisements (ads) and participant accrual.ResultsThe isafe trial was launched on September 17, 2012. Placement of ads in an online classified advertising platform increased the average number of recruited participants per month from 2 to 25. Over the 23-month recruitment period, the registration website recorded 4176 unique visitors. Among 1003 women meeting eligibility criteria, 51.55% (517) consented to participate; among the 501 women who enrolled (consented, validated, and randomized), 412 (82.2%) were accrued (completed baseline assessments). The majority (n=52, 58%) of the 89 women who dropped out between enrollment and accrual never logged in to the allocated isafe website. Of every 4 accrued women, 3 (314/412, 76.2%) identified the classified ad as their referral source, followed by friends and family (52/412, 12.6%). Women recruited through a friend or relative were more likely to self-identify as indigenous Māori and live in the highest-deprivation areas. Ads increased the accrual rate by a factor of 74 (95% CI 49–112).ConclusionsPrint advertisements, website links, and networking were costly and inefficient methods for recruiting participants to a Web-based eHealth trial. Researchers are advised to limit their recruitment efforts to Web-based online marketplace and classified advertising platforms, as in the isafe case, or to social media. Online classified advertising in “Jobs–Other–volunteers” successfully recruited a diverse sample of women experiencing intimate partner violence. Preintervention recruitment data provide critical information to inform future research and critical analysis of Web-based eHealth trials.ClinicalTrialAustralian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000708853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000708853 (Archived by WebCite at http://www.webcitation/6lMGuVXdK)

Community-Based Culturally Preferred Physical Activity Intervention Targeting Populations at High Risk for Type 2 Diabetes: Results and Implications.

In Canada, an ageing population, obesity rates and high risk among certain ethnocultural populations are driving diabetes prevalence. Given the burden associated with type 2 diabetes and its link to modifiable risk factors, this study aimed to implement culturally preferred physical activities at the community level, targeting individuals at high risk for type 2 diabetes. Glycated hemoglobin (A1C) levels were used to detect potential improvements in glycemic control. Participants were screened for diabetes risk using a questionnaire and capillary point-of-care A1C blood testing. Participants were offered community-based physical activity classes 2 to 3 times per week for 6 months. A subset of participants (n=84) provided additional measurements. In total, 718 subjects were reached during recruitment. Substantial participant dropout took place, and 487 participants were exposed to the intervention. Among those who participated in the physical activity and provided follow up, mean A1C levels were reduced by 0.17 (p=0.002) after 3 months (n=84) and by 0.06 (p=0.35; n=49) after 6 months. The homeostatic model assessment (HOMA-beta) showed a significant improvement of 23.6% after 3 months (n=20; p=0.03) and 45.2% after 6 months (n=12; p=0.02). Resting systolic blood pressure and diastolic blood pressure plus combined hand-grip strength improved after 6 months (n=12). Implementation of this community-based, culturally preferred physical activity program presented several challenges and was associated with significant participant dropout. After considering participant dropout, the relatively small group who participated and provided follow-up measures showed improvements various physiologic measures. Despite efforts to enhance accessibility, it appears that several barriers to physical activity participation remain and need to be explored to enhance the success of future programs.