ArticleLiterature Review

Systematic review identifies number of strategies important for retaining study participants

September 2007
Journal of Clinical Epidemiology 60(8):757-65

DOI:10.1016/j.jclinepi.2006.11.023

Source
PubMed

Authors:

Cheryl R Dennison Himmelfarb

Johns Hopkins University

Dawn Wayman

National Institutes of Health

Peter J Pronovost

Johns Hopkins Medicine

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Loss to follow-up threatens internal and external validity yet little research has examined ways to limit participant attrition. We conducted a systematic review of studies with a primary focus on strategies to retain participants in health care research. We completed searches of PubMed, CINAHL, CENTRAL, Cochrane Methodology Register, and EMBASE (August 2005). We also examined reference lists of eligible articles and relevant reviews. A data-driven thematic analysis of the retention strategies identified common themes. We retrieved 3,068 citations, 21 studies were eligible for inclusion. We abstracted 368 strategies and from these identified 12 themes. The studies reported a median of 17 strategies across a median of six themes. The most commonly reported strategies were systematic methods of participant contact and scheduling. Studies with retention rates lower than the mean rate (86%) reported fewer strategies. There was no difference in the number of different themes used. Available evidence suggests that investigators should consider using a number of retention strategies across several themes to maximize the retention of participants. Further research, including explicit evaluation of the effectiveness of different strategies, is needed.

Financial analysis of a locomotor exercise trial for post-stroke recovery: insights from the HIT Stroke Trial

Article

Full-text available

Sep 2024

Background Navigating the complexities of post-stroke recovery trials requires addressing challenges in participant recruitment and retention and effective resource management to ensure trial success. The aim of this study was to examine the financial requirements associated with conducting the Moderate-Intensity Exercise vs. High-Intensity Interval Training to Recover Walking Post-Stroke (HIT Stroke Trial) at a single site encompassing a wide catchment area, recognizing the intricate challenges of participant recruitment and retention inherent in post-stroke recovery trials. Methods To determine cost, study expense reports were gathered and divided into seven categories: recruitment, screening assessments, baseline assessments, intervention, outcome assessments, retention, and oversight. Categories were then further divided into chronological order for initial contact and prescreening, consenting, initial screening, and baseline testing. The 12-week intervention was divided into 4-week blocks: intervention block 1, post 4-week outcome testing, intervention block 2, post 8-week outcome testing, intervention block 3, and post 12-week outcome testing. Results Total direct cost for site execution was

539,768 with cost per participant approximated as

35,984. Oversight costs accounted for 65.8% of the budget at

355,661. To achieve goals related to inclusive participant recruitment (

21,923) and retention (

28,009), our site costs totaled

49,932. Direct study-related costs included screening assessments (

5,905), baseline assessments (

15,028), intervention (

76,952), and outcome assessments (

36,288). Discussion Clinical trials focusing on walking rehabilitation and exercise, particularly those requiring multiple assessment visits, demand rigorous oversight. This cost analysis provides important and critical insight into the expenses required to successfully execute an exercise-based walking rehabilitation trial in the United States.

Transitions from short to long-term outcomes in pediatric critical care: considerations for clinical practice

Article

Full-text available

Oct 2021

Most children are surviving critical illness in highly resourced pediatric intensive care units (PICUs). However, in research studies, many of these children survive with multi-domain health sequelae that has the potential to affect development over many years, termed post-intensive care syndrome-pediatrics (PICS-p). Clinically, there are no recommendations for the assessment and follow-up of children with critical illness as exists for the premature neonatal and congenital heart disease populations. In research studies, primary and secondary outcomes are largely assessed at or prior to hospital discharge, disregarding post-hospital outcomes important to PICU stakeholders. Incorporating longer term outcomes into clinical and research programs, however, can no longer be overlooked. Barriers to outcomes assessments are varied and generalized vs. individualized, but some PICU centers are discovering how to overcome them and are providing this service to families—sometimes specific populations—in need. Research programs and funders are increasingly recognizing the value and need to assess long-term outcomes post-PICU. Finally, we should seek the strong backing of the PICU community and families to insist that long-term outcomes become our new clinical standard of care. PICUs should consider development of a multicenter, multinational collaborative to assess clinical outcomes and optimize care delivery and patient and family outcomes. The aim of this review is to present the potential considerations of implementing long-term clinical follow-up following pediatric critical illness.

Securing Participant Engagement in Longitudinal Substance Use Disorder Recovery Research: A Qualitative Exploration of Key Retention Factors

Article

Full-text available

Dec 2021

The longitudinal cohort study is the gold standard in observational epidemiology. A central challenge with this design is the risk of attrition over time, especially in studies of inaccessible clinical populations, such as individuals with substance use disorder (SUD). Research on individuals who have achieved stable substance use abstinence and functional recovery is scarce. 30 participants from a longitudinal cohort study (the Stayer study), were interviewed concerning their experiences of participation over several years to explore retention factors. Interviewers with first-hand experience of recovery from SUD conducted the interviews. Data were analyzed using a thematic analytic approach within an interpretative–phenomenological framework. The analyses yielded the following themes: (1) Individuals’ substance use: adaptation to slips and relapses in treatment and research, (2) “Show that you care”: Developing working relationships in research with study participants by negotiating expectations flexibly, and (3) “You don’t just make dropouts”: A long-term focus on study participation and treatment can increase retention. Several factors were perceived as relevant to participation in a long-term follow-up study with diverse recovery routes, including working research relationships and explicit contracts allowing follow-up participation, even during periods of drug use. Longitudinal studies could benefit from including such factors in the tracking procedures in addition to more traditional tracking techniques. Clinical services could benefit from developing interventions that use knowledge of long-term recovery processes as non-linear, heterogeneous trajectories, and proactive approaches to motivate recovery.

Effectiveness of incentives to improve the reach of health promotion programs- a systematic review and meta-analysis

Article

Jul 2022
PREV MED

The reach (i.e., enrollment, engagement, and retention) of health promotion evidence-based programs (EBPs) at the participant level has been challenging. Incentives based on behavioral economics may be used to improve EBP reach. We aimed to systematically review and synthesize the evidence of the effectiveness of incentives as a dissemination strategy to increase EBP reach. We conducted a literature search in PubMed, SCOPUS, EMBASE, Cochrane Review and Cochrane CENTRAL for articles published between January 2000 and March 2020 to identify incentive strategies used to increase program reach among health promotion EBPs. Inclusion criteria included studies published in English, experimental or quasi-experimental designs, comparison of incentive to non-incentive or control strategies, and reported on reach (n = 35 health promotion studies). Monetary incentives using cash and a fixed schedule of reinforcement were the most used incentive schemes (71%). Incentives alone or combined with other strategies as a multicomponent approach were effective in improving program enrollment, engagement, and retention. Specifically, incentive strategies were associated with higher odds of program enrollment (odds ratio [OR], 2.78; 95% confidence interval [CI], 1.82-4.24; n = 10) and retention (OR, 2.54, 95% CI, 1.34-4.85; n = 9) with considerable heterogeneity (I2 = 94% and 91%, respectively). Incentives are a promising individual-level dissemination strategy to improve the reach of health promotion EBPs. However, understanding the optimal amount, type, frequency, and target of incentives, and how incentives fit in a multicomponent approach in different contexts requires further research.

Survey of data collection methods and retention strategies in European birth cohorts of children and adults born very preterm

Article

Dec 2021

Background The long-term follow-up of very preterm and very low birthweight cohorts contributes to valuable evidence to understand life-course outcomes in these vulnerable populations. However, attrition is a major challenge in long-term outcome studies. Examining the techniques used by existing cohorts may help to reveal practices that enhance willingness to continue participation over time. Objectives To evaluate the effect of data collection methods and retention strategies on overall retention in European birth cohorts of individuals born very preterm and very low birthweight. Methods A survey of European cohorts integrated in the RECAP-preterm Consortium provided data on study characteristics, retention at the most recent follow-up, data collection methods and retention strategies. Cohorts were classified according to participants’ age at most recent follow-up as child (<18) or adult cohorts (≥18 years old). Results Data were obtained for 17 (81%) cohorts (7 adult and 10 child) in 12 countries. Considering the baseline, at the most recent follow-up, overall retention ranged from 10% to 99%. Child cohorts presented higher median retention (68% versus 38% or 52% for adult cohorts with ≤5 or >5 follow-ups) and used relatively more retention strategies. For contact and invitation, cohorts mostly resorted to invitation letters, and to face-to-face interviews for assessments. Study duration was negatively correlated with retention and positively associated with the number of follow-up evaluation. We identified 109 retention strategies, with a median of 6 per cohort; bond-building (n = 41; 38%) was the most utilised, followed by barrier-reduction (n = 36; 33%) and reminders (n = 32; 29%). Retention was not influenced by category or number of strategies. Conclusions Regular contact with cohort participants favour retention whilst neither the number nor the categories of retention strategies used seemed to have an influence, suggesting that tailored strategies focussed on participants at higher risk of dropout might be a more effective approach.

Mental Health and Well-Being During the First vs. Second COVID-19 Pandemic Lockdown in Cyprus

Article

Full-text available

Sep 2021

Introduction: Following the onset of the COVID-19 pandemic, most countries imposed strict governmental lockdowns. Research investigating the psychological impact of pandemic-induced lockdowns is accumulating, though to date no study has examined the psychological health and associated parameters of well-being in countries that underwent additional lockdowns as the pandemic continued into resurgence “waves.” Aim: The present study provides an overview of the psychological impact of COVID-19 across the two lockdowns in the Cypriot population. Methods: In total, 957 participants completed an online survey during the first lockdown, 134 of whom completed a similar survey again during the second lockdown. The outcomes assessed included stress, positive and negative affect, and well-being. Results: The results indicated no population-wide severe reactions in the participants. Repeated measures analyses showed similar mental health levels during both the first and the second lockdowns. Further inspection of participants’ scores indicated that, for all mental health variables, approximately half of the participants improved, while the other half deteriorated. Discussion: Perceived social support and psychological flexibility predicted most psychological outcomes during both lockdowns. Further research is necessary to understand the continuing effects of the pandemic and associated lockdowns on mental health.

Assessing the feasibility of public engagement in a smartphone app to improve well-being through nature connection ( Evaluación de la factibilidad de la implicación ciudadana mediante una app de teléfonos inteligentes para mejorar el bienestar a través de la conexión con la naturaleza )

Article

Jan 2021

Aside from practical interventions such as providing green infrastructure to improve air quality or water contamination and reduce flooding, well-being interventions to increase engagement with the natural environment are one of the fastest growing ways of improving human and environmental health. This feasibility study assessed a novel smartphone app for well-being intervention. Over 30 days the app prompted adults, including those seeking help for a common mental health problem, to notice the good things about urban green or built spaces (control condition). Self-referral was successful with 885 people downloading the app, 435 supplying baseline data and 50 supplying post-intervention data. However, the low number of observations (M = 6 per participant) indicates that 30 days is too long to remain engaged. There were significant improvements in well-being and nature connection, but no difference between green and built space conditions. Limitations, future recommendations regarding improving engagement and marketing to lower socio-economic status groups are discussed.

Participant engagement and involvement in longitudinal cohort studies: qualitative insights from a selection of pregnancy and birth, twin, and family-based population cohort studies

Article

Full-text available

Dec 2024
BMC MED RES METHODOL

Background Longitudinal cohort studies are pivotal to understand how socioeconomic, environmental, biological, and lifestyle factors influence health and disease. The added value of cohort studies increases as they accumulate life course data and expand across generations. Ensuring that participants stay motivated to contribute over decades of follow-up is, however, challenging. Participant engagement and involvement (PEI) aims to secure the long-term commitment of participants and promote researcher-participant interaction. This study explored PEI practices in a selection of pregnancy and birth, twin, and family-based population cohort studies. Methods Purposive sampling was used to identify cohorts in Europe, Australia and New Zealand. Fourteen semi-structured digital interviews were conducted with cohort study representatives to explore strategies for participant recruitment, informed consent, communication of general and individual information to participants, data collection, and participant involvement. Experiences, resources allocated to PEI, and reflections on future PEI, were discussed. The interview data were analyzed using a content analysis approach and summary results were reviewed and discussed by the representatives. Results The cohort studies used various strategies to recruit participants including support from health professionals and organizations combined with information on the studies’ web sites and social media. New approaches such as intra-cohort recruitment, were being investigated. Most cohorts transitioned from paper-based to digital solutions to collect the participants’ consent and data. While digital solutions increased efficiency, they also brought new challenges. The studies experimented with the use of participant advisory panels and focus groups to involve participants in making decisions, although their success varied across age and socio-economic background. Most representatives reported PEI resources to be limited and called for more human, technical, educational and financial resources to maximize the positive effects of PEI. Conclusions This study of PEI among well-established cohort studies underscores the importance of PEI for project sustainability and highlights key factors to consider in developing PEI. Our analysis shows that knowledge gaps exist regarding which approaches have highest impact on retention rates and are best suited for different participant groups. Research is needed to support the development of best practices for PEI as well as knowledge exchange between cohorts through network building.

The Comparison of High-Intensity Interval Training and Moderate-intensity Continuous Training on Inflammatory and Metabolic Variables in Type 2 Diabetes: Study Protocol for A Pilot Randomized Controlled Trial

Article

Full-text available

Mar 2024

Original Article Background: The worldwide prevalence of type 2 diabetes mellitus (T2DM) is rapidly increasing, and research has shown that low-grade inflammation leads to the development and progress of T2DM. Participating in physical activities, as part of the management program, is recommended to control inflammation and prevent the complications of T2DM. Although the most effective type and intensity of exercise training are not recognized yet, aerobic training has been reported to have beneficial effects. This manuscript describes the protocol of a study, in which we compared the effectiveness of 8 weeks of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) on inflammatory, metabolic, and anthropometric variables in type 2 diabetes patients. Methods/Design: This study was designed as a pilot randomized controlled clinical trial with three parallel groups. Twenty-seven adults with type 2 diabetes were randomly assigned 1:1:1 to HIIT, MICT, and control groups. Participants in the HIIT and MICT groups were invited to undertake three sessions of supervised exercise each week for eight consecutive weeks. HIIT sessions consisted of seven 1-min intervals of running exercise on a treadmill at 90%–95% heart rate reserve (HRR) separated by 2 min of active recovery at 60%–70% HRR. MICT sessions involved 30 min of continuous running on the treadmill at 60%–70% HRR. Participants were assessed 24 h before the start and 24 and 72 h after the last training session. The control group, however, continued their everyday life during the project. The primary outcomes were the alterations of plasma calprotectin, myeloperoxidase (MPO), and interleukin-6. Conclusion: Evidence shows the link between inflammation and the development of type 2 diabetes complications. Therefore, finding ways to improve inflammatory state is of vital importance to these patients. This study is the first clinical trial comparing the impact of long-term HIIT and MICT on calprotectin and MPO for people with type 2 diabetes.

Longitudinal cohort study investigating neurodevelopmental and socioemotional outcomes in school- entry aged children after open heart surgery in Australia and New Zealand: the NITRIC follow-up study protocol

Article

Full-text available

Aug 2023

Introduction Despite growing awareness of neurodevelopmental impairments in children with congenital heart disease (CHD), there is a lack of large, longitudinal, population-based cohorts. Little is known about the contemporary neurodevelopmental profile and the emergence of specific impairments in children with CHD entering school. The performance of standardised screening tools to predict neurodevelopmental outcomes at school age in this high-risk population remains poorly understood. The NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC) trial randomised 1371 children <2 years of age, investigating the effect of gaseous nitric oxide applied into the cardiopulmonary bypass oxygenator during heart surgery. The NITRIC follow-up study will follow this cohort annually until 5 years of age to assess outcomes related to cognition and socioemotional behaviour at school entry, identify risk factors for adverse outcomes and evaluate the performance of screening tools. Methods and analysis Approximately 1150 children from the NITRIC trial across five sites in Australia and New Zealand will be eligible. Follow-up assessments will occur in two stages: (1) annual online screening of global neurodevelopment, socioemotional and executive functioning, health-related quality of life and parenting stress at ages 2–5 years; and (2) face-to-face assessment at age 5 years assessing intellectual ability, attention, memory and processing speed; fine motor skills; language and communication; and socioemotional outcomes. Cognitive and socioemotional outcomes and trajectories of neurodevelopment will be described and demographic, clinical, genetic and environmental predictors of these outcomes will be explored. Ethics and dissemination Ethical approval has been obtained from the Children’s Health Queensland (HREC/20/QCHQ/70626) and New Zealand Health and Disability (21/NTA/83) Research Ethics Committees. The findings will inform the development of clinical decision tools and improve preventative and intervention strategies in children with CHD. Dissemination of the outcomes of the study is expected via publications in peer-reviewed journals, presentation at conferences, via social media, podcast presentations and medical education resources, and through CHD family partners. Trial registration number The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry as ‘Gene Expression to Predict Long-Term Neurodevelopmental Outcome in Infants from the NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC) Study – A Multicentre Prospective Trial’. Trial registration: ACTRN12621000904875.

School Counseling Research: Advancing the Professional Evidence Base

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Jul 2023

Research in the Schools: Advancing the Evidence Base for the School Counseling Profession provides accessible and actionable strategies for conducting school counseling research with a focus on student outcomes. The text is organized to support new research from the starting point of collaborative relationships with school partners and the ethical and developmental considerations of this kind of work. It thoughtfully provides a pathway for moving through the multiple measurement and design decisions that are part of meaningful and impactful research. Each chapter provides practical details and tangible applications, as well as extensive resources and relevant examples. Anyone interested in conducting research that provides the school counseling profession with nuanced, rich information about how best to support student development, that creates truly equitable opportunities for all youth, and that moves the profession forward will find this book useful and engaging.

Research Design: Quantitative Approaches

Chapter

Jul 2023

'Just one interview': making visible the hidden workload associated with qualitative research

Article

Full-text available

Apr 2023

Background: Appropriate costing and allocation of resources is vital to ensure that recruitment to a study is achieved on time and on target. However, there is little guidance concerning the workload associated with qualitative research. Aim: To review the planned versus actual workloads in a qualitative sub-study following elective cardiac surgery in children. Discussion: Parents of children approached for a clinical trial were invited to participate in a semi-structured interview to explore their views about making decisions concerning their children's participation in the trial. A workload audit was conducted using anticipated points of contact with participants, and the duration of activities identified in the protocol and Health Research Authority statement of activities; these were compared with timed activities documented by the research team. Conclusion: The current system did not anticipate or capture the workload associated with conducting a relatively straightforward qualitative sub-study of a clinical trial with a research-engaged patient group. Implications for practice: Understanding the hidden workload associated with qualitative research is vital in ensuring that project timelines, recruitment targets and funding for research staff are realistic.

Achieving mental health equity in Black male suicide prevention

Article

Full-text available

Mar 2023

Despite a steady decrease in suicide rates in the United States, the rate among Black males has increased in recent decades. Moreover, suicide is now positioned as the third leading cause of death in this population, signaling a public health crisis. Enhancing the ability for future suicide prevention scholars to fully characterize and intervene on suicide risk factors is an emerging health equity priority, yet there is little empirical evidence to robustly investigate the alarming trends in Black male suicide. We present fundamental areas of expansion in suicide prevention research focused on establishing culturally responsive strategies to achieve mental health equity. Notably, we identify gaps in existing research and offer future recommendation to reduce suicide death among Black males. Our perspective aims to present important and innovative solutions for ensuring the inclusion of Black males in need of suicide prevention and intervention efforts.

Perceived research burden of a novel therapeutic intervention: A study of transcranial magnetic stimulation for smoking cessation

Article

Full-text available

Mar 2023

Background: Translating repetitive transcranial magnetic stimulation (rTMS) into evidence-based clinical applications relies on research volunteers with different perspectives on the burden of study participation. Additionally, clinical applications of rTMS require multiple visits over weeks or months, the impact of research burden is an important component for these studies and translation of these findings to clinical practice. High frequency rTMS has significant potential to be developed as an evidence-based treatment for smoking cessation, however, the optimal rTMS dosing strategies have yet to be determined. Participant burden is an important component of determining optimal dosing strategy for rTMS as a treatment for long-term smoking cessation. Methods: In this double-blinded, sham-controlled, randomized design, the effects of treatment duration, intensity, and active/sham assignment of rTMS on research burden were examined. Results: Overall level of perceived research burden was low. Experienced burden (M = 26.50) was significantly lower than anticipated burden (M = 34.12). Research burden did not vary by race or income. Conclusions: Overall research burden was relatively low. Contrary to our hypotheses, we found little evidence of added significant burden for increasing the duration or intensity of rTMS, and we found little evidence for differences in research burden by race or income. Clinical trial registration: identifier NCT03865472.

A workflow for incorporating cross-sectional data into the calibration of dynamic models

Preprint

Full-text available

Jan 2023

Mathematical modelling and dynamic simulations are commonly used in systems medicine to investigate the interactions between various biological entities in time. The level of model complexity is mainly restricted by the number of model parameters that can be estimated from available experimental data and prior knowledge. The calibration of dynamic models usually requires longitudinal data from multiple individuals, which is challenging to obtain and, consequently, not always available. On the contrary, the collection of cross-sectional data is often more feasible. Here, we demonstrate how the parameters of individual dynamic models can be estimated from such cross-sectional data using a Bayesian updating method. We illustrate this approach on a model for puberty in girls with cross-sectional hormone measurement data.

Development of a Positive Psychology Well-Being Intervention in a Community Pharmacy Setting

Article

Full-text available

Jan 2023

Community pharmacies are well‐placed to deliver well‐being interventions;however, to date, nothing has been produced specifically for this setting. The aim of this study was to develop a positive psychology intervention suitable for a community pharmacy setting with the goal of increasing the well‐being of community members. Methods: Intervention development consisted of three steps: Step 1—identify the evidence-base and well-being model to underpin the basis of the intervention (Version 1); Step 2—model the intervention and gather user feedback to produce Version 2, and Step 3—revisit the evidence-base and refine the intervention to produce Version 3. Results: Findings from nine studies (seven RCTs, one cross-sectional, one N-1 design plus user feedback were applied to model a 6-week ‘Prescribing Happiness (P-Hap)’ intervention, underpinned by the PERMA model plus four other components from the positive psychology literature (Three Good Things, Utilising Your Signature Strengths in New Ways, Best Possible Selves and Character Strengths). A PERMA-based diary was designed to be completed 3 days a week as part of the intervention. Conclusions: This work is an important development which will direct the future implementation of interventions to support well-being in this novel setting. The next stage is to gain the perspectives of external stakeholders on the feasibility of delivering the P-Hap for its adoption into community pharmacy services in the future.

Development of a Positive Psychology Well-Being Intervention in a Community Pharmacy Setting

Preprint

Nov 2022

Background: Community pharmacies are well-placed to deliver well-being interventions; however, to date, nothing has been produced specifically for this setting. The aim of this study was to develop a positive psychology intervention suitable for a community pharmacy setting with the goal of increasing the well-being of community members. Methods: Intervention development consisted of three steps: Step 1- identify the evidence-base and well-being model to underpin the basis of the intervention (Version 1); Step 2 - model the intervention and gather user feedback to produce Version 2, and Step 3 - revisit the evidence-base and refine the intervention to produce Version 3. Results: Findings from nine studies (seven RCTs, one cross-sectional, one N-1 design plus user feedback were applied to model a 6-week ‘Prescribing Happiness (P-Hap)’ intervention, underpinned by the PERMA model plus four other components from the positive psychology literature (Three Good Things, Utilising Your Signature Strengths in New Ways, Best Possible Selves and Character Strengths). A PERMA-based diary was designed to be completed 3-days a week as part of the intervention. Conclusions: This work is an important development which will direct the future implementation of interventions to support well-being in this novel setting. The next stage is to gain the perspectives of external stakeholders on the feasibility of delivering the P-Hap for its adoption into community pharmacy services in the future.

Proper understanding of recurrent stress urinary incontinence treatment in women (PURSUIT): a randomised controlled trial of endoscopic and surgical treatment

Article

Full-text available

Aug 2022
TRIALS

Background Women with stress urinary incontinence (SUI) experience urine leakage with physical activity. Currently, the interventional treatments for SUI are surgical, or endoscopic bulking injection(s). However, these procedures are not always successful, and symptoms can persist or come back after treatment, categorised as recurrent SUI. There are longstanding symptoms and distress associated with a failed primary treatment, and currently, there is no consensus on how best to treat women with recurrent, or persistent, SUI. Methods A two-arm trial, set in at least 20 National Health Service (NHS) urology and urogynaecology referral units in the UK, randomising 250 adult women with recurrent or persistent SUI 1:1 to receive either an endoscopic intervention (endoscopic bulking injections) or a standard NHS surgical intervention, currently colposuspension, autologous fascial sling or artificial urinary sphincter. The aim of the trial is to determine whether surgical treatment is superior to endoscopic bulking injections in terms of symptom severity at 1 year after randomisation. This primary outcome will be measured using the patient-reported International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF). Secondary outcomes include assessment of longer-term clinical impact, improvement of symptoms, safety, operative assessments, sexual function, cost-effectiveness and an evaluation of patients’ and clinicians’ views and experiences of the interventions. Discussion There is a lack of high-quality, randomised, scientific evidence for which treatment is best for women presenting with recurrent SUI. The PURSUIT study will benefit healthcare professionals and patients and provide robust evidence to guide further treatment and improve symptoms and quality of life for women with this condition . Trial registration International Standard Randomised Controlled Trials Number (ISRCTN) registry ISRCTN12201059. Registered on 09 January 2020

Strategies for participant retention in long term clinical trials: A participant –centric approaches

Article

Full-text available

Jul 2022
Perspect Clin Res

A clinical trial is the most foolproof method to evaluate the efficacy of a new intervention. Successful completion of clinical trials depends on the retention of the participants enrolled. Poor participant retention can lead to significant time and cost burden and have potentially adverse biases on the results. A high retention rate of participants is an important criterion for the validity and credibility of randomized controlled clinical trials. Many long-term trials fail due to low retention of study participants. Efforts at participant retention should start even before the first participant is recruited into the study. Retention is not only the responsibility of the investigators but also all other stakeholders in a clinical trial. In recent years, retention materials, participant camps, and introduction of national study coordinators have helped in improving retention. Quality of the relationship developed between the research staff and the study participant is a key factor for success of any trial. In our experience, in the context of resource-challenged low- and middle-income countries, we have found that it is possible to achieve high retention rates, 95%–100%. The rapport built between the investigating team and the participant plays a vital role in retention. In addition, personalized care, including listening to the participant's problems and enabling to contact investigators or study team at any time of the day, has shown benefits in retention.

Strategies Associated with Retaining Participants in the Longitudinal National Alzheimer’s Coordinating Center Uniform Data Set Study

Article

Full-text available

Apr 2022
J ALZHEIMERS DIS

Background: Best approaches for retaining research participants in Alzheimer's disease cohort studies are understudied. Objective: Using data from the National Alzheimer's Coordinating Center Uniform Data Set, we evaluated the associations of unique strategies with participant retention across Alzheimer's Disease Research Centers and explored potential effect modification by race/ethnicity and diagnostic group. Methods: We examined retention at the first follow-up visit among participants enrolled during 2015-2017. Structured surveys ascertained 95 retention tactics among 12 strategies. Strategy-specific summary scores were created based on the number of implemented tactics for each strategy and grouped into tertiles. Generalized estimating equations were constructed to evaluate associations of strategy scores and the odds of retention, controlling for age, sex, education, race and ethnicity, study partner type, marital status, visit length, battery length, and diagnostic group. Separate models were stratified by race/ethnicity and diagnostic group. Effect modification was formally tested with interaction terms. Results: Among 5,715 total participants enrolled, 4,515 were Non-Hispanic White (79%), 335 were Hispanic/Latino (6%), 651 were Non-Hispanic Black (11%), and 214 were Non-Hispanic Asian (4%). Compared to the lowest tertile of scores, the highest tertile of scores involving improvement in study personnel and communication of study requirements and details were associated with 61% higher odds of retention in fully adjusted models (adjusted Odds Ratios [aOR] = 1.61, 95% Confidence Interval [CI] = 1.05-2.47 and aOR = 1.55, 95% CI = 1.03-2.35, respectively). We did not find evidence for effect modification. Conclusion: In the setting of limited resources, specific retention strategies may be more valuable than others.

Strategies to Enhance Retention in a Cohort Study Among Adults of Turkish Descent Living in Berlin

Article

Full-text available

Oct 2022

Retention is important for statistical power and external validity in long-term cohort studies. The aims of our study were to evaluate different retention strategies within a cohort study of adults of Turkish descent in Berlin, Germany, and to compare participants and non-participants. In 2011–2012, a population-based study was conducted among adults of Turkish descent to primarily examine recruitment strategies. 6 years later, the participants were re-contacted and invited to complete a self-report questionnaire regarding their health status, health care utilization, and satisfaction with medical services. The retention strategy comprised letters in both German and Turkish, phone calls, and home visits (by bilingual staff). We calculated the response rate and retention rate, using definitions of the American Association for Public Opinion Research, as well as the relative retention rate for each level of contact. Associations of baseline recruitment strategy, sociodemographic, migration-related and health-related factors with retention were investigated by logistic regression analysis. Of 557 persons contacted, 249 (44.7%) completed the questionnaire. This was 50.1% of those whose contact information was available. The relative retention rate was lowest for phone calls (8.9%) and highest for home visits (18.4%). Participants were more often non-smokers and German citizens than non-participants. For all remaining factors, no association with retention was found. In this study, among adults of Turkish descent, the retention rate increased considerably with every additional level of contact. Implementation of comprehensive retention strategies provided by culturally matched study personnel may lead to higher validity and statistical power in studies on migrant health issues.

What Works Best to Engage Participants in Mobile App Interventions and e-Health: A Scoping Review

Article

Full-text available

Oct 2021
TELEMED J E-HEALTH

Background Despite the growing popularity of mobile app interventions, specific engagement components of mobile apps have not been well studied. Methods The objectives of this scoping review are to determine which components of mobile health intervention apps encouraged or hindered engagement, and examine how studies measured engagement. Results A PubMed search on March 5, 2020 yielded 239 articles that featured the terms engagement, mobile app/mobile health, and adult. After applying exclusion criteria, only 54 studies were included in the final analysis. Discussion Common app components associated with increased engagement included: personalized content/feedback, data visualization, reminders/push notifications, educational information/material, logging/self-monitoring functions, and goal-setting features. On the other hand, social media integration, social forums, poor app navigation, and technical difficulties appeared to contribute to lower engagement rates or decreased usage. Notably, the review revealed a great variability in how engagement with mobile health apps is measured due to lack of established processes. Conclusion There is a critical need for controlled studies to provide guidelines and standards to help facilitate engagement and its measurement in research and clinical trial work using mobile health intervention apps.

Healthy for My Baby Research Protocol- a Randomized Controlled Trial Assessing a Preconception Intervention to Improve the Lifestyle of Overweight Women and Their Partners

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Full-text available

Aug 2021

Background: Preconception lifestyle interventions appear promising to reduce pregnancy complications, prevent adult cardiometabolic diseases, and prevent childhood obesity. These interventions have almost exclusively been studied in populations of obese infertile women. The development of preconception lifestyle interventions targeting a broader population of overweight and obese women without a history infertility and their partners is needed. Methods: This study is a multicenter open label parallel group randomized controlled trial. Sixty-eight non-infertile women with overweight or obesity in the preconception period and their partners will be recruited from the Sherbrooke and Quebec City regions. The couples will be randomized in a 1:1 ratio to receive the Healthy for my Baby intervention or standard care in the preconception period and pregnancy. Women and their partners will be invited to take part in this lifestyle intervention which includes motivational interviews and daily self-monitoring of lifestyle goals through a mobile phone application. The primary endpoint of this study is the diet quality of women during the preconception period, which will be evaluated using the C-HEI 2007 score at baseline, 2, 4- and 6-months following study enrolment. Women's dietary quality will also be evaluated through the measure of urinary biomarkers of habitual dietary intake at baseline and 2 months in preconception, and 24–26 weeks in pregnancy. Additional indicators of women's lifestyle as well as anthropometric measures will be documented in preconception and pregnancy. For the pregnancy period, the main secondary endpoint is the pattern of gestational weight gain. Pregnancy and neonatal complications will also be evaluated. For partners, diet quality, other lifestyle habits, and anthropometric measures will be documented in the preconception and pregnancy periods. Discussion: This study will evaluate the effectiveness of a low-cost intervention designed to improve diet and other lifestyle characteristics of women in the preconception period who are overweight or obese. If the Healthy for my Baby intervention is efficacious regarding dietary measures, larger trials will be needed to evaluate the impact of this intervention on the rates of pregnancy complications, childhood obesity, and adult cardiometabolic disease. Clinical Trial Registration: clinicaltrials.gov (NCT04242069).

Recruitment and retention rates in randomised controlled trials of exercise therapy in people with multimorbidity: a systematic review and meta-analysis

Article

Full-text available

Jun 2021
TRIALS

Aim To quantify recruitment, retention and differential retention rates and associated trial, participant and intervention characteristics in randomised controlled trials (RCTs) evaluating the effect of exercise therapy in people with multimorbidity. Data sources MEDLINE, EMBASE, CINAHL and CENTRAL from 1990 to April 20, 2020. Study selection RCTs including people with multimorbidity comparing exercise therapy with a non-exposed comparator group reporting at least one of the following outcomes: physical function, health-related quality of life, depression symptoms, or anxiety symptoms. Data extraction and synthesis Recruitment rates (proportion of people randomised/proportion of people eligible), retention rates (proportion of people providing the outcomes of interest/proportion randomised) and differential retention rates (difference in proportion of people providing the outcomes in the intervention group and comparator group) were calculated. Meta-analysis using a random-effects model was used to estimate pooled proportions. Methodological quality was assessed using Cochrane ´Risk of Bias tool 2.0´ for individual studies, and the GRADE approach was used to assess the overall quality of the evidence. Results Twenty-three RCTs with 3363 people were included. The pooled prevalence for recruitment rate was 75% (95%CI 66 to 84%). The pooled prevalence for retention rate was 90% (95%CI 86 to 94%) at the end of the intervention (12 weeks; interquartile range (IQR) (12 to 12)). Meta-regression analyses showed that increasing age and including a higher proportion of people with hypertension was associated with lower retention rates. Retention rates did not differ between the intervention and comparator groups. The overall quality of the evidence was deemed very low. Conclusion Three in four eligible people with multimorbidity were randomised to RCTs using exercise therapy, of which nine out of 10 provided end of treatment outcomes with no difference seen between the intervention and comparison groups. However, the results must be interpreted with caution due to large differences between the included studies. Trial registration ClinicalTrials.gov CRD42020161329 . Registered on 28 April 2020.

The effect of remuneration schedule on data completion and retention in the pregnancy eating attributes study (PEAS)

Article

Full-text available

May 2021
PLOS ONE

Maximizing data completion and study retention is essential in population research. This study examined the effect of remuneration schedule and data collection modality on data completion and retention in the Pregnancy Eating Attributes Study cohort. Participants (n = 458) completed online surveys and attended six in-person study visits. Initially, remuneration was a prespecified amount per visit, then was changed mid-study to be prorated based on the number of forms completed. Additionally, survey data collection modality was changed to in-person at the sixth study visit. In this secondary data analysis, there was no effect of remuneration schedule on withdrawal rates or time-to-withdrawal. Survey completion was significantly lower under prorated remuneration at the first visit but did not significantly differ at subsequent visits. The lump sum group had significantly greater odds of completely the first and second trimester dietary record (OR = 4.1, OR = 2.6, respectively) then the prorated group but were almost half as likely to complete the dietary record at the 6-month postpartum visit (OR = 0.5). Survey completion at sixth visit was significantly higher for in-person versus online completion (68.6% vs. 93.1%). Findings suggest that remuneration schedule and data collection modality can impact completion of self- reported assessments.

Measuring the long-term effects of informal science education experiences: challenges and potential solutions

Article

Full-text available

Dec 2021

Despite the fact that most science learning takes place outside of school, little is known about how engagement in informal science learning (ISL) experiences affects learners’ knowledge, skill development, interest, or identities over long periods of time. Although substantial ISL research has documented short-term outcomes such as the learning that takes place during a science center visit, research suggests that the genuine benefits of informal experiences are long-term transformations in learners as they pursue a “cascade” of experiences subsequent to the initial educational event. However, a number of major methodological challenges have limited longitudinal research projects investigating the long-term effects of ISL experiences. In this paper we identify and address four key issues surrounding the critical but challenging area of how to study and measure the long-term effects or impacts of ISL experiences: attribution, attrition, data collection, and analytic approaches. Our objective is to provide guidance to ISL researchers wishing to engage in long-term investigations of learner outcomes and to begin a dialogue about how best to address the numerous challenges involved in this work.

Generative adversarial networks for imputing missing data for big data clinical research

Article

Full-text available

Apr 2021
BMC MED RES METHODOL

Background Missing data is a pervasive problem in clinical research. Generative adversarial imputation nets (GAIN), a novel machine learning data imputation approach, has the potential to substitute missing data accurately and efficiently but has not yet been evaluated in empirical big clinical datasets. Objectives This study aimed to evaluate the accuracy of GAIN in imputing missing values in large real-world clinical datasets with mixed-type variables. The computation efficiency of GAIN was also evaluated. The performance of GAIN was compared with other commonly used methods, MICE and missForest. Methods Two real world clinical datasets were used. The first was that of a cohort study on the long-term outcomes of patients with diabetes (50,000 complete cases), and the second was of a cohort study on the effectiveness of a risk assessment and management programme for patients with hypertension (10,000 complete cases). Missing data (missing at random) to independent variables were simulated at different missingness rates (20, 50%). The normalized root mean square error (NRMSE) between imputed values and real values for continuous variables and the proportion of falsely classified (PFC) for categorical variables were used to measure imputation accuracy. Computation time per imputation for each method was recorded. The differences in accuracy of different imputation methods were compared using ANOVA or non-parametric test. Results Both missForest and GAIN were more accurate than MICE. GAIN showed similar accuracy as missForest when the simulated missingness rate was 20%, but was more accurate when the simulated missingness rate was 50%. GAIN was the most accurate for the imputation of skewed continuous and imbalanced categorical variables at both missingness rates. GAIN had a much higher computation speed (32 min on PC) comparing to that of missForest (1300 min) when the sample size is 50,000. Conclusion GAIN showed better accuracy as an imputation method for missing data in large real-world clinical datasets compared to MICE and missForest, and was more resistant to high missingness rate (50%). The high computation speed is an added advantage of GAIN in big clinical data research. It holds potential as an accurate and efficient method for missing data imputation in future big data clinical research. Trial registration ClinicalTrials.gov ID: NCT03299010 ; Unique Protocol ID: HKUCTR-2232

The Impact of Social Support on Treatment Participation and Completion in a Disability Prevention Intervention for Older Adults

Article

Full-text available

Mar 2021
J AGING HEALTH

Objectives: This study evaluates the role of emotional and instrumental social support on treatment participation and completion using the Positive Minds-Strong Bodies (PMSB) disability prevention program. Methods: Data from a multisite randomized controlled trial of the PMSB program for older adults (≥60 years) with physical impairment and mild to severe depression and/or anxiety were used. Participants were randomly assigned to receive 10 sessions of cognitive behavior therapy (CBT) plus 36 sessions of group exercise or usual care. Results: Adjusting for covariates, higher levels of emotional social support at baseline were associated with increased odds of completing the recommended number of CBT sessions (6 or more, OR = 2.58, p = .030), attending 5.56 more exercise sessions ( p = .006), and increased odds of completing the recommended exercise sessions (25 or more, OR = 2.37, p = .047). Discussion: Emotional social support appears to increase dosage in a disability prevention program.

Retaining Adolescent and Young Adult Participants in Research During a Pandemic: Best Practices From Two Large-Scale Developmental Neuroimaging Studies (NCANDA and ABCD)

Article

Full-text available

Jan 2021

The novel coronavirus pandemic that emerged in late 2019 (COVID-19) has created challenges not previously experienced in human research. This paper discusses two large-scale NIH-funded multi-site longitudinal studies of adolescents and young adults – the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA) and the Adolescent Brain Cognitive Development (ABCD) Study – and valuable approaches to learn about adaptive processes for conducting developmentally sensitive research with neuroimaging and neurocognitive testing across consortia during a global pandemic. We focus on challenges experienced during the pandemic and modifications that may guide other projects, such as implementing adapted protocols that protect the safety of participants and research staff, and addressing assessment challenges through the use of strategies such as remote and mobile assessments. Given the pandemic’s disproportionate impacts on participants typically underrepresented in research, we describe efforts to retain these individuals. The pandemic provides an opportunity to develop adaptive processes that can facilitate future studies’ ability to mobilize effectively and rapidly.

Early Environmental Exposures and Contaminants: a Design Framework for Biospecimen Collection and Analysis for a Prospective National Birth Cohort

Article

Full-text available

Dec 2020

Identifying factors associated with disruptions in early neurodevelopment is imperative for promoting the health and wellbeing of children. We describe a design framework for biospecimen collection for the forthcoming HEALthy Brain and Child Development (HBCD) study, which seeks to establish a large cohort of pregnant women throughout the USA and follow their children into middle childhood. Biospecimens and biological outcomes of interest, together with validated questionnaires and other measures, may help to disentangle the effect of prenatal exposures from social and environment factors that extend across the prenatal and postnatal periods, including early life adversity (ELA). Biospecimen selection is discussed across four domains of interest: (a) substance use exposure, (b) other environmental exposures, (c) genomics and epigenomics, and (d) other biological markers of neurodevelopment and putative moderators and mediators of developmental effects. HBCD biospecimen working group recommendations were based on nine guiding principles including utility as a biomarker to assess neurodevelopment; feasibility of collection during critical periods of exposure with a broad detection window; logistics and cost of specimen collection, storage, and transportation; cultural acceptability; minimal invasiveness; flexibility; high sensitivity and specificity; anticipated expertise and infrastructure at participating sites; and availability of informative alternative non-biological measures. The proposed essential and recommended biospecimens will need to be integrated with the recommendations from other HBCD working groups to ascertain overall burden for the research participants and families, feasibility of multi-modal collection at each study visit, cost, and implications for recruitment and retention, as well as any potential legal repercussions.

Impact of a Case-Based Sleep Apnoea Education on the Knowledge, Attitudes and Confidence of Dental Hygiene Students-A Multicentre Intervention Study

Article

Oct 2024
Int J Dent Hyg

Objective: This pilot study aimed to explore knowledge, attitudes and confidence levels of Obstructive Sleep Apnoea (OSA) before and after case-based education among dental hygiene students. Moreover, to give an international perspective, this study included students from the US and Scandinavia. Methods: A longitudinal multicentre study assessed dental hygiene students' OSA knowledge, attitudes and confidence through a case-based education model. Students from six dental hygiene programmes in the US, Norway and Sweden participated from 2021 to 2022. The intervention group (N = 89) received preview material, live synchronous OSA lecture, case-based screening of fictitious patients and clinical practice using the STOP-Bang screening tool. Controls (N = 70) followed the standard curriculum. The Obstructive Sleep Apnoea Knowledge and Attitudes (OSAKA) questionnaire, comprising 18 knowledge and five attitude/confidence questions, was used. Reliability was assessed and nonparametric tests determined OSAKA knowledge score differences among the baseline, 6 months and 12 months intervals. Results: The intervention increased OSA knowledge with the largest increase in proportions of correct responses occurring between the baseline and 6 months and all single items showing a higher proportion of correct answers at 12 months compared to the baseline. Students' attitudes regarding the importance of OSAKA and confidence in managing patients increased from the baseline to both 6 months and 12 months. Conclusion: The case based educational intervention increased OSA knowledge and improved attitudes and confidence among dental hygiene students. The results also determined that the OSAKA questionnaire can be used in a setting with dental hygiene students to provide an overview of their knowledge, attitudes and confidence toward OSA. Current sleep medicine education in dental hygiene programmes is limited, suggesting the need for enhanced and sustained educational interventions to address this knowledge gap.

Examining Caregiver Practices During Adolescent Outpatient Alcohol Use and Co-Occurring Mental Health Treatment: A Dyadic Ecological Momentary Assessment Protocol (Preprint)

Article

Jun 2024

Structures and Strategies for Retaining an International Pediatric Cohort from Birth: Lessons from The Environmental Determinants of Diabetes in the Young (TEDDY) Study

Preprint

Full-text available

May 2024

Background: Retention of study participants in observational studies is essential to maintaining the representativeness of the population, minimizing selection bias, and assuring sufficient statistical power. The aim of this report is to describe the structures and strategies used to retain participants in The Environmental Determinants of Diabetes in the Young (TEDDY) Study, an observational study of children at increased genetic risk for type 1 diabetes followed in an intense protocol with frequent clinic visits from birth until age 15. Methods: A systematic review of methodologies used to retain research subjects identified four domains: barrier reduction strategies; community building strategies; follow-up/reminder strategies; and tracing strategies. Independent reviewers categorized the retention strategies implemented by the TEDDY Study into each of these domains. Strategies not fitting into any of these categories were placed into a fifth category unique to TEDDY. Results: TEDDY identified over one hundred retention strategies used during the 15 years of follow-up; most could be categorized in these domains. Those unique to TEDDY included (1) study organization and structures to support retention; (2) efforts to meet the changing developmental needs of the TEDDY population, (3) implementation of efforts to address protocol challenges in real-time; and (4) employment of a re-engagement protocol for those who had dropped out of the study. Conclusion: Pediatric cohort studies should include strategies, structures, and resources addressing retention at the study's initiation. It is recommended that child and parent engagement in addition to the developmental needs of the child be an integrated focus of all strategies. Putting mechanisms in place to address protocol and retention challenges in real time would facilitate effectively addressing challenges as they arise. Trial registration: ClinicalTrials.gov Identifier: NCT00279318

Recruitment and retention of American Indian youth and caregivers in a culturally adapted prevention program

Article

Dec 2023

This article seeks to understand to what extent cultural engagement and substance use risk factors influence families’ decisions to participate, and ultimately complete, a culturally grounded substance use prevention program. Using data from a 14-week culturally oriented family-based substance use prevention program, we examine predictors of successful recruitment and retention of American Indian youth and their caregivers. Guided by the theoretical model for developing culturally specific preventions, the community-based approach to recruitment resulted in 85.6% of eligible families from two American Indian communities agreeing to participate in the randomized controlled trial. After completion of baseline surveys, 57.3% of the intervention selected families initiated participation in the program sessions and 67.8% of these families completed participation in the program. We used logistic regression to analyze two different models: one that predicted whether invited families chose to participate and whether participating families attended eight or more sessions. Important predictors of participation in the intervention program included single-caregiver households, youth Indigenous language and cultural identity, youth early substance use initiation, and household substance use exposure. Overall, results from this study highlight the importance of fully engaged community research partnerships for multi-session family-based interventions, while identifying potential challenges to program recruitment and participation.

Engaging Adolescents in Contemporary Longitudinal Health Research: Strategies for Promoting Participation and Retention

Article

Sep 2023
J ADOLESCENT HEALTH

Purpose: High (and nonselective) recruitment and retention rates in longitudinal studies of adolescence are essential for illuminating health trajectories and determinants during this critical period. Knowledge of optimal recruitment and retention strategies must keep pace with emerging challenges and opportunities, such as the shifts towards digitally-based data collection. Methods: We used a narrative review approach to synthesize research on promising recruitment and retention strategies for optimizing engagement in the next generation of longitudinal adolescent health studies. Results: We identified a small number of well-evidenced strategies, emerging challenges and opportunities for recruitment and retention in contemporary studies, and key evidence gaps. Core recommendations include the use of well-evidenced strategies (e.g., incentivizing participation, reducing barriers and burden, and investing in building positive relationships with participants) and coproducing recruitment and retention strategies with adolescents and parents of adolescents. Discussion: More research is needed into successful recruitment/retention strategies for digital/remote data collection methods, but initial evidence suggests that adopting principles and adapting well-evidenced strategies from traditional longitudinal studies is promising.

Exploring participant attrition in a longitudinal follow-up of older adults: the Global Longitudinal Study of Osteoporosis in Women (GLOW) Hamilton cohort

Article

Full-text available

Jul 2023

Objective We explored the magnitude of attrition, its pattern and risk factors for different forms of attrition in the cohort from the Global Longitudinal Study of Osteoporosis in Women. Design Prospective cohort study. Setting Participants were recruited from physician practices in Hamilton, Ontario. Participants Postmenopausal women aged ≥55 years who had consulted their primary care physician within the last 2 years. Outcome measures Time to all-cause, non-death, death, preventable and non-preventable attrition. Results All 3985 women enrolled in the study were included in the analyses. The mean age of the cohort was 69.4 (SD: 8.9) years. At the end of the follow-up, 30.2% (1206/3985) of the study participants had either died or were lost to follow-up. The pattern of attrition was monotone with most participants failing to return after a missed survey. The different types of attrition examined shared common risk factors including age, smoking and being frail but differed on factors such as educational level, race, hospitalisation, quality of life and being prefrail. Conclusion Attrition in this ageing cohort was selective to some participant characteristics. Minimising potential bias associated with such non-random attrition would require targeted measures to achieve maximum possible follow-rates among the high-risk groups identified and dealing with specific reasons for attrition in the study design and analysis.

Retention strategies among those on community supervision in the South: Lessons learned during the COVID-19 pandemic

Article

Full-text available

Apr 2023
PLOS ONE

Objectives Cohort studies must implement effective retention strategies to produce internally valid and generalizable results. Ensuring all study participants are retained, particularly those involved in the criminal legal system, ensures study findings and future interventions will be relevant to this group, who are often lost to follow-up: critical to achieving health equity. Our objective was to characterize retention strategies and describe overall retention among an 18-month longitudinal cohort study of persons on community supervision prior to and during the COVID-19 pandemic. Methods We implemented various retention strategy best-practices (e.g., multiple forms of locator information, training study staff on rapport building, study-branded items). During the COVID-19 pandemic, we developed and describe new retention strategies. We calculated overall retention and analyzed differences between those retained and lost to follow-up by demographic characteristics. Results Prior to the start of the COVID-19 pandemic, 227 participants enrolled across three sites (N = 46 North Carolina; N = 99 Kentucky; N = 82 Florida). Of these, 180 completed the final 18-month visit, 15 were lost to follow-up, and 32 were ineligible. This resulted in an overall retention of 92.3% (180/195). While most participant characteristics did not differ by retention status, a greater proportion of those experiencing unstable housing were lost to follow-up. Conclusion Our findings highlight that when retention strategies are flexible, particularly during a pandemic, high retention is still achievable. In addition to retention best-practices (e.g., frequent requests for updated locator information) we suggest other studies consider retention strategies beyond the study participant (e.g., paying participant contacts) and incentivize on-time study visit completion (e.g., providing a bonus when completed the study visit on time).

Enhancing the Cardiovascular Safety of Hemodialysis Care Using Multimodal Provider Education and Patient Activation Interventions: Protocol (Preprint)

Article

Full-text available

Feb 2023

Background: End-stage kidney disease (ESKD) is treated with dialysis or kidney transplantation, with most patients with ESKD receiving in-center hemodialysis treatment. This life-saving treatment can result in cardiovascular and hemodynamic instability, with the most common form being low blood pressure during the dialysis treatment (intradialytic hypotension [IDH]). IDH is a complication of hemodialysis that can involve symptoms such as fatigue, nausea, cramping, and loss of consciousness. IDH increases risks of cardiovascular disease and ultimately hospitalizations and mortality. Provider-level and patient-level decisions influence the occurrence of IDH; thus, IDH may be preventable in routine hemodialysis care. Objective: This study aims to evaluate the independent and comparative effectiveness of 2 interventions-one directed at hemodialysis providers and another for patients-in reducing the rate of IDH at hemodialysis facilities. In addition, the study will assess the effects of interventions on secondary patient-centered clinical outcomes and examine factors associated with a successful implementation of the interventions. Methods: This study is a pragmatic, cluster randomized trial to be conducted in 20 hemodialysis facilities in the United States. Hemodialysis facilities will be randomized using a 2 × 2 factorial design, such that 5 sites will receive a multimodal provider education intervention, 5 sites will receive a patient activation intervention, 5 sites will receive both interventions, and 5 sites will receive none of the 2 interventions. The multimodal provider education intervention involved theory-informed team training and the use of a digital, tablet-based checklist to heighten attention to patient clinical factors associated with increased IDH risk. The patient activation intervention involves tablet-based, theory-informed patient education and peer mentoring. Patient outcomes will be monitored during a 12-week baseline period, followed by a 24-week intervention period and a 12-week postintervention follow-up period. The primary outcome of the study is the proportion of treatments with IDH, which will be aggregated at the facility level. Secondary outcomes include patient symptoms, fluid adherence, hemodialysis adherence, quality of life, hospitalizations, and mortality. Results: This study is funded by the Patient-Centered Outcomes Research Institute and approved by the University of Michigan Medical School's institutional review board. The study began enrolling patients in January 2023. Initial feasibility data will be available in May 2023. Data collection will conclude in November 2024. Conclusions: The effects of provider and patient education on reducing the proportion of sessions with IDH and improving other patient-centered clinical outcomes will be evaluated, and the findings will be used to inform further improvements in patient care. Improving the stability of hemodialysis sessions is a critical concern for clinicians and patients with ESKD; the interventions targeted to providers and patients are predicted to lead to improvements in patient health and quality of life. Trial registration: ClinicalTrials.gov NCT03171545; https://clinicaltrials.gov/ct2/show/NCT03171545. International registered report identifier (irrid): PRR1-10.2196/46187.

Proper Understanding of Recurrent Stress Urinary Incontinence Treatment in women (PURSUIT): A Randomised Controlled Trial of Endoscopic and Surgical Treatment

Preprint

Full-text available

Jun 2022

Background: Women with stress urinary incontinence (SUI) experience urine leakage with physical activity. Currently the interventional treatments for SUI are surgical, or endoscopic bulking injection(s). However, these procedures are not always successful, and symptoms can persist or come back after treatment, categorised as recurrent SUI. There are longstanding symptoms and distress associated with a failed primary treatment and currently there is no consensus on how best to treat women with recurrent, or persistent, SUI. Methods: A two-arm trial, set in at least 20 National Health Service (NHS) urology and urogynaecology referral units in the United Kingdom, randomising 250 adult women with recurrent or persistent SUI 1:1 to receive either an endoscopic intervention (endoscopic bulking injections) or a standard NHS surgical intervention, currently colposuspension, autologous fascial sling or artificial urinary sphincter. The aim of the trial is to determine whether surgical treatment is superior to endoscopic bulking injections in terms of symptom severity at 1-year after randomisation. This primary outcome will be measured using the patient-reported International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF). Secondary outcomes include assessment of longer-term clinical impact, improvement of symptoms, safety, operative assessments, sexual function, cost-effectiveness and an evaluation of patients’ and clinicians’ views and experiences of the interventions. Discussion: There is a lack of high-quality, randomised, scientific evidence for which treatment is best for women presenting with recurrent SUI. The PURSUIT study will benefit healthcare professionals and patients and provide robust evidence to guide further treatment and improve symptoms and quality of life for women with this condition. Trial registration: International Standard Randomised Controlled Trials Number (ISRCTN) registry, ID: ISRCTN12201059. Registered on 09 January 2020.

Evaluation of Pressing Issues in Ecological Momentary Assessment

Article

Dec 2022

The use of repeated, momentary, real-world assessment methods known as the Experience Sampling Method and Ecological Momentary Assessment (EMA) has been broadly embraced over the last few decades. These methods have extended our assessment reach beyond lengthy retrospective self-reports as they can capture everyday experiences in their immediate context, including affect, behavior, symptoms, and cognitions. In this review we evaluate nine conceptual, methodological, and psychometric issues about EMA with the goal of stimulating conversation and guiding future research on these matters: the extent to which participants are actually reporting momentary experiences, respondents’ interpretation of momentary questions, the use of comparison standards in responding, efforts to increase the EMA reporting period beyond the moment to longer periods within a day, training of EMA study participants, concerns about selection bias of respondents, the impact of missing EMA assessments, the reliability of momentary data, and for which purposes EMA might be considered a gold standard for assessment. Resolution of these issues should have far-reaching implications for advancing the field. Expected final online publication date for the Annual Review of Clinical Psychology, Volume 19 is May 2023. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

Becoming with Care in Drug Treatment Services: The Recovery Assemblage

Book

Full-text available

Nov 2022

Lena Theodoropoulou

Establishing requirements for technology to support clinical trial retention: a systematic scoping review and analysis using Self-Determination Theory (Preprint)

Article

Full-text available

Apr 2022
J MED INTERNET RES

Background: Retaining participants in clinical trials is an established challenge. Currently, the industry is moving to a technology-mediated, decentralized model for running trials. The shift presents an opportunity for technology design to aid the participant experience and promote retention; however, there are many open questions regarding how this can be best supported. We advocate the adoption of a stronger theoretical position to improve the quality of design decisions for clinical trial technology to promote participant engagement. Objective: This study aimed to identify and analyze the types of retention strategies used in published clinical trials that successfully retain participants. Methods: A systematic scoping review was carried out on 6 electronic databases for articles published from 1990 to September 2020, namely CINAHL, The Cochrane Library, EBSCO, Embase, PsycINFO, and PubMed, using the concepts "retention," "strategy," "clinal trial," and "clinical research." This was followed by an analysis of the included articles through the lens of self-determination theory, an evidence-based theory of human motivation. Results: A total of 26 articles were included in this review. The motivational strategies identified in the clinical trials in our sample were categorized into 8 themes: autonomy; competence; relatedness; controlled motivation; branding, communication material, and marketing literature; contact, tracking, and scheduling methods and data collection; convenience to contribute to data collection; and organizational competence. The trials used a wide range of motivational strategies. Notably, the trials often relied on controlled motivation interventions and underused strategies to support intrinsic motivation. Moreover, traditional clinical trials relied heavily on human interaction and "relatedness" to support motivation and retention, which may cause problems in the move to technology-led decentralized trials. We found inconsistency in the data-reporting methods and that motivational theory-based approaches were not evident in strategy design. Conclusions: This study offers direction and a framework to guide digital technology design decisions for future decentralized clinical trials to enhance participant retention during clinical trials. This research defines previous clinical trial retention strategies in terms of participant motivation, identifies motivational strategies, and offers a rationale for selecting strategies that will improve retention. It emphasizes the benefits of using theoretical frameworks to analyze strategic approaches and aid decision-making to improve the quality of technology design decisions.

Previous Treatments

Chapter

Oct 2022

This chapter relates to the previous treatment of inpatients/clients in the research sample and their choice of TC, where they had been rehabilitated. The correlations between SUDs and treatment careers are also discussed here. The chapter also contains machine-generated summaries of five relevant scientific papers.

Retention in a 6-Month Smoking Cessation Study Among Alaska Native and American Indian People

Article

Sep 2022
AM INDIAN ALASKA NAT

Participant retention in longitudinal health research is necessary for generalizable results. Understanding factors that correlate with increased retention could improve retention in future studies. Here, we describe how participant and study process measures are associated with retention in a longitudinal tobacco cessation research study performed in Anchorage, Alaska. Specifically, we conducted a secondary analysis exploring retention among 151 Alaska Native and American Indian (ANAI) people and described our study processes using study retention categories from a recent meta-analysis. We found that our study processes influence retention among ANAI urban residents more than measures collected about the participant. For study process measures, calls where a participant answered and calls participants placed to the study team were associated with higher retention. Calls where the participant did not answer were associated with lower retention. For participant measures, only lower annual income was associated with lower retention at 6 weeks. Promoting communication from participants to the study team could improve retention, and alternative communication methods could be used after unsuccessful calls. Finally, categorizing our study retention strategies demonstrated that additional barrier-reduction strategies might be warranted.

Factors associated with dropout in the longitudinal Vogel Study of cognitive decline

Article

Sep 2021

Dementia, including Alzheimer’s Disease (AD), is a growing problem worldwide. Prevention or early detection of the disease or a prodromal cognitive decline is necessary. By means of our long-term follow-up “Vogel Study”, we aim to predict the pathological cognitive decline of a German cohort (mean age was 73.9 ± 1.55 years at first visit) with three measurement time points within 6 years per participant. Especially in samples of the elderly and subjects with chronic or comorbid diseases, dropouts are one of the biggest problems of long-term studies. In contrast to the large number of research articles conducted on the course of dementia, little research has been done on the completion of treatment. To ensure unbiased and reliable predictors of cognitive decline from study completers, our objective was to determine predictors of dropout. We conducted multivariate analyses of (co-)variance (MANCOVAs) and multinomial logistic regression analyses to compare and predict the subject’s dropout behavior at the second visit 3 years after baseline (full participation, partial participation, no participation/dropout) with neuropsychiatric, cognitive, blood, and lifestyle variables. Lower performance in declarative memory, attention, and visual-spatial processing predicted dropout rather than full participation. Lower performance in visual-spatial processing predicted partial participation as opposed to full participation. Furthermore, lower performance in Mini-Mental Status Examination (MMSE) predicted whether subjects dropped out or participated partially instead of full participation. Baseline cognitive parameters are associated with dropouts at follow-up with a loss of impaired participants. We expect a bias into a healthier sample over time.

From cohort to community: The emotional work of birthday cards in the Medical Research Council National Survey of Health and Development, 1946–2018

Article

Full-text available

May 2021
HIST HUM SCI

The Medical Research Council National Survey of Health and Development (NSHD) is Britain’s longest-running birth cohort study. From their birth in 1946 until the present day, its research participants, or study members, have filled out questionnaires and completed cognitive or physical examinations every few years. Among other outcomes, the findings of these studies have framed how we understand health inequalities. Throughout the decades and multiple follow-up studies, each year the study members have received a birthday card from the survey staff. Although the birthday cards were originally produced in 1962 as a method to record changes of address at a time when the adolescent study members were potentially leaving school and home, they have become more than that with time. The cards mark, and have helped create, an ongoing evolving relationship between the NSHD and the surveyed study members, eventually coming to represent a relationship between the study members themselves. This article uses the birthday cards alongside archival material from the NSHD and oral history interviews with survey staff to trace the history of the growing awareness of importance of emotion within British social science research communities over the course of the 20th and early 21st centuries. It documents changing attitudes to science’s dependence on research participants, their well-being, and the collaborative nature of scientific research. The article deploys an intertextual approach to reading these texts alongside an attention to emotional communities drawing on the work of Barbara Rosenwein.

Maximizing Participant Engagement, Participation and Retention in Cohort Studies using Digital Methods: Rapid Review to Inform the Next Generation of Very Large Birth Cohorts (Preprint)

Article

Full-text available

Aug 2020
J MED INTERNET RES

Background Many current research needs can only be addressed using very large cohorts. In such studies, traditional one-on-one phone, face-to-face, or paper-based engagement may not be feasible. The only realistic mechanism for maintaining engagement and participation at this scale is via digital methods. Given the substantial investment being made into very large birth cohort studies, evidence for optimal methods of participant engagement, participation, and retention over sustained periods without in-person contact from researchers is paramount. Objective This study aims to provide an overview of systematic reviews and meta-analyses evaluating alternative strategies for maximizing participant engagement and retention rates in large-scale studies using digital methods. Methods We used a rapid review method by searching PubMed and Ovid MEDLINE databases from January 2012 to December 2019. Studies evaluating at least 1 e-engagement, participation, or retention strategy were eligible. Articles were screened for relevance based on preset inclusion and exclusion criteria. The methodological quality of the included reviews was assessed using the AMSTAR-2 (Assessing the Methodological Quality of Systematic Reviews 2) measurement tool, and a narrative synthesis of the data was conducted. ResultsThe literature search yielded 19 eligible reviews. Overall, 63% (n=12) of these reviews reported on the effectiveness of e-engagement or participation promotion strategies. These evaluations were generally not conducted within very large observational digital cohorts. Most of the contributing reviews included multipurpose cohort studies (with both observational and interventional elements) conducted in clinical and research settings. Email or SMS text message reminders, SMS text messages or voice notifications, and incentives were the most commonly used design features to engage and retain participants. For parental outcomes, engagement-facilitation interventions influenced uptake and behavior change, including video feedback, goal setting, and intensive human facilitation and support. Participant-stated preferences for content included new knowledge, reminders, solutions, and suggestions about health issues presented in a clear, short, and personalized way. Perinatal and postpartum women valued self-monitoring and personalized feedback. Digital reminders and multiple SMS text messages were specific strategies that were found to increase adherence to medication and clinic attendance, respectively. Conclusions This review adds to the growing literature evaluating methods to optimize engagement and participation that may apply to large-scale studies using digital methods; it is promising that most e-engagement and participation promotion strategies appear to be effective. However, these reviews canvassed relatively few strategies, suggesting that few alternative strategies have been experimentally evaluated. The reviews also revealed a dearth of experimental evidence generated within very large observational digital cohort studies, which may reflect the small number of such studies worldwide. Thus, very large studies may need to proactively build in experimental opportunities to test engagement and retention approaches to enhance the success of their own and other large digital contact studies.

It Takes a Village: Evaluating the Feasibility and Acceptability of a Community-Based Parenting Program

Article

Full-text available

Dec 2020

Background: A community-academic partnership responded to a community-voiced need to address parenting challenges while living in poverty. Purpose: To evaluate the feasibility and acceptability of a community-based intervention that included positive parenting strategies to build and support healthy families, and behavioral health promotion. Design: Multi-method pilot study Findings: Focus group participants (n=11) valued the program highly. There were no changes in participants' (n=36) Perceived Stress Scale scores after program completion (p>0.05, d=0.063). Conclusions: Participants were highly engaged throughout the program and requested a longer duration of the intervention to continue to build social connectivity.

Recruitment and Retention for the Evaluation of a Healthy Food Initiative in Economically Disadvantaged, Majority African American Communities

Article

Jan 2021

Effective recruitment and retention supports equitable participation in research. The aim of this article is to describe recruitment and retention methods among residents of highly disadvantaged, predominantly African American communities in the southeastern United States during the evaluation of a healthy food access initiative. We proposed that active and passive recruitment methods, intensive retention strategies, community outreach and involvement, over-enrollment to anticipate attrition, and applied principles of community participation would achieve the study's recruitment and retention goals. The enrollment goal of 560 was met at 94% (n = 527), and the retention goal of 400 was achieved (n = 408).

Recruitment and Retention of Homeless Mentally Ill Participants in Research

Article

Full-text available

Oct 1996

Are the unstable residential and personal lives of homeless mentally ill (HMI ) individuals so difficult as to preclude their inclusion in rigorous, longitudinal research protocols? The continued presence of HMI individuals in U.S. society has prompted the mental health research community to reconsider the question of whether clinical trial and demonstration research protocols are feasible with this population. This article briefly examines the existing research literature on recruitment and retention rates in recent studies of this population and, in more detail, the specific strategies used by researchers to recruit and retain HMI individuals as research participants. In general, with sufficient resources and the persistent use of existing strategies for recruitment and retention, HMI individuals can be successfully studied over time. Finally, to demonstrate this potential, the recruitment and retention strategies of the San Diego McKinney Homeless Mentally Ill Demonstration Research Program are described. (PsycINFO Database Record (c) 2012 APA, all rights reserved)

Risk status for dropping out of developmental followup for very low birth weight infants

Article

Full-text available

Sep 1993

Not keeping scheduled visits for medical care is a major health care issue. Little research has addressed how the interaction of demographic and biomedical parameters with psychosocial processes has an impact on appointment keeping. Typical factors are stress of daily living, methods of coping, social support, and instrumental support (that is, tangible assistance). In this study, the authors examine the role of these parameters and processes in the risk status for dropping out of a developmental followup program for very low birth weight infants. The findings suggest that the stress of daily living is a significant predictor for the mother's return when the infant is 6 months of age (corrected for prematurity). The predictors for return at 24 months corrected age include marital status, race, gestational age of the infant, maternal intelligence, and efficacy expectations. Providing transportation was found to be a successful intervention strategy for a subgroup at very high risk for dropping out due to a constellation of biomedical, demographic, and psychosocial factors.

Retention of women enrolled in a prospective study of human immunodeficiency virus infection: impact of race, unstable housing, and use of human immunodeficiency virus therapy

Article

Full-text available

Oct 2001
AM J EPIDEMIOL

Even though women and people of color represent an increasing proportion of US acquired immunodeficiency syndrome (AIDS) cases, few research studies include adequate representation of these populations. Here the authors describe recruitment and retention of a diverse group of human immunodeficiency virus (HIV)-infected and at risk HIV-uninfected women in a prospective study operating in six sites across the United States. Methods used to minimize loss to follow-up in this cohort are also described. For the first 10 study visits that occurred during a 5-year period between 1994 and 1999, the retention rate of participants was approximately 82%. In adjusted Cox analysis, factors associated with retention among all women were older age, African-American race, stable housing, HIV-infected serostatus, past experience in studies of HIV/AIDS, and site of enrollment. In an adjusted Cox analysis of HIV-infected women, African-American race, past experience in studies of HIV/AIDS, site of enrollment, and reported use of combination or highly active antiretroviral HIV therapy at the last visit were significantly associated with retention. In adjusted Cox analysis of HIV-uninfected study participants, only the site of enrollment was significantly associated with study retention. These results show that women with and at risk for HIV infection, especially African-American women, can be successfully recruited and retained in prospective studies.

Motivating patients to participate in clinical trials

Article

Jan 1999

K. Lilley

At the present time, there is a notable shift of emphasis within clinical research circles towards the importance of strategies to optimise patient recruitment, compliance and retention. No longer is it accepted as the norm that clinical studies will inevitably slip and stall in relation to their original timeline forecasts. The challenge, within what seems to be an increasingly difficult research environment, of meeting and beating recruitment targets - or indeed of recruiting any patients at all - is discussed.

Strategies to improve recruitment to research studies

Chapter

Jul 2002

Researchers do many untested things to try to increase recruitment into studies. Many studies fail to recruit their planned number of participants. Using effective ways to improve recruitment would be of benefit to the research community and society. The reviewers did not find any trials of methods aimed at researcher collaborators or ethics committees. Fifteen trials of methods aimed at participants were identified, but the results are not easily generalizable.

Overcoming obstacles to recruitment and retention of subjects in clinical studies

Article

Jan 1994
J Clin Res Drug Dev

Recruitment of suitable subjects is one of the most challenging aspects of a clinical study. Major obstacles to recruitment are lack of awareness of studies and time constraints. There are numerous ways to disseminate information about clinical studies including paid advertisements, public service announcements, and word of mouth. Whatever the population being studied, the key to recruitment consists of identifying large groups of potential subjects and finding creative ways to draw their attention and interest. Using a variety of recruitment tactics is more effective than relying on only one. Retention of subjects begins during recruitment, and the consent form is one of the key tools. A thorough explanation of risks, benefits, procedures, and time requirements at the beginning of the study helps prevent dropouts. A relationship of trust between subject and investigator and attention to the subject's convenience help to promote compliance and increase the subject's willingness to participate in future trials.

Epidemiology: Beyond the Basics

Article

Apr 2001
AM J EPIDEMIOL

M. Szklo

Written for those who are familiar with the basic strategies of analytic epidemiology, Epidemiology: Beyond the Basics takes readers through a more rigorous discussion of key epidemiologic concepts and methods such as study design, measures of association, research assessment, and more. With real-life examples throughout, the book avoids complex statistical formulations and is an invaluable resource for intermediate students and practicing epidemiologists who wish to expand their knowledge of epidemiology and its role in the medical and public health sciences. The Third Edition offers a completely revamped page design that will make it easier for your students to navigate through the many charts, graphs, and mathematical formulas. It also offers expanded chapter exercises, new and updated references throughout, as well as coverage of some new topics including: * Over-diagnosis Bias (Ch. 4); * "Joint Presence of Two Factors that Interact as a Confounding Variable" (Ch. 6); * "Alternative Approaches for the Control of Confounding" (Ch. 7); * "Final Considerations" (Ch.8); * Decision trees (Ch. 10) This edition also offers an updated package of instructor materials including instructor's manual, PowerPoint lecture slides, and a test bank.

Retention of Women Enrolled in a Prospective Study of Human Immunodeficiency Virus Infection: Impact of Race, Unstable Housing, and Use of Human Immunodeficiency Virus Therapy

Article

Sep 2001
AM J EPIDEMIOL

Nancy A Hessol

Research Fundamentals: Follow-up of Subjects in Clinical Trials: Addressing Subject Attrition

Article

Aug 2004

Robert Woolard

Many published clinical trials have less than adequate follow-up. When conducting a clinical trial, researchers attempt to minimize data loss; however, some data may not be collected, particularly when subjects are lost to follow-up. Careful planning of research protocols, including comprehensive initial data collection, identification of locators, flexible scheduling, systematic subject tracking, monitoring subject loss, and systematically approaching problem cases can ensure high follow-up rates. This article presents a compendium of techniques and procedures that researchers can use to enhance follow-up and address attrition in their studies. Finally, this article outlines statistical techniques that can be used to address the effects of missing data, particularly when patients are lost to follow-up.

Patient recruitment and retention strategies in randomised controlled trials

Article

Oct 1998

Recruitment and Retention of Elderly Patients in Clinical Trials: Issues and Strategies

Article

May 2001
AM J GERIAT PSYCHIAT

Erin L Cassidy-Eagle

Brief Communication: A Trial that Failed, and the Reasons Why: Comparing the Minnesota Model with Outpatient Treatment and Non-treatment for Alcohol Disorders

Article

Sep 1990

A randomised clinical trial was conducted in order to compare treatment results between Minnesota model treatment for alcohol abuse and outpatient treatment. The trial had to be discontinued due to problems in recruitment of subjects and a high rate of attrition among subjects allocated to Minnesota model treatment. In this paper the problems encountered during the trial are discussed. Different methods of recruitment of subjects to a randomised trial are compared.

Fundamentals of Clinical Trials

Book

Jan 1985

This is the fourth edition of a very successful textbook on clinical trials methodology, written by three recognized experts who have long and extensive experience in all areas of clinical trials. Most chapters have been revised considerably from the third edition. A chapter on ethics has been added and topics such as noninferiority and adaptive designs now receive considerable discussion. There is much new material on adverse events, adherence, data monitoring, and issues in analysis. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials from a variety of medical disciplines to illustrate the fundamentals. The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan, and reporting the trial results according to the pre-specified objectives. Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful. This book has been successfully used for teaching courses in clinical trial methodology. © Springer Science + Business Media, LLC 2010. All rights aeserved.

Epdemiology Beyond the Basics

Book

Jan 2000

Subject retention in a controlled clinical trial

Article

Aug 1997
J ADV NURS

Threats to subject retention in a controlled clinical trial require strategies that encourage continued participation of subjects, with consideration of the effect of the strategies on the dependent variable. Methods to encourage retention must be based on sensitivity to the patient's changing condition and perspective. Primary considerations in the design and implementation of an intervention study are the acceptability of the intervention to particular patients and the compatibility of the intervention with other care activities. In addition, qualities of the research personnel and changes in patient conditions are important factors in retention of subjects. Vignettes illustrate the threats to retention and solutions used in a clinical trial. Threats to retention include the research nurse's approach and patient factors such as worries, control issues, visitors, symptoms of confusion and pain, and lack of cooperation. Retention strategies include supporting and educating research nurses, providing empathy and respect, including patients in decisions, negotiating with visitors, alleviating symptoms, and supporting a plan of care consistent with both the research protocol and the patient's recovery. While providing a similar approach to all groups, experimental researchers in a variable clinical environment must also provide some individualization and communication to retain valuable subjects who are ill.

Recruitment and Retention in an Alcohol Prevention Program at Two Inner‐City Middle Schools

Article

Aug 1998
J SCHOOL HEALTH

This study examined recruitment within an alcohol prevention program at two diverse inner-city schools and retention of these students through follow-up at one month and one year. Subjects in Cohort 1 included 211 sixth grade students from one inner-city, neighborhood school. Subjects in Cohort 2 included 650 sixth grade students from one neighborhood school (n=388) and one magnet (bused) school (n=262). Recruitment rates differed between the two Cohort 2 urban schools. However, when eligibility criteria were considered, recruitment rates were nearly identical. At one-month posttest, dropouts were more at risk for alcohol use initiation than nondropouts. At one-year follow-up, dropouts were more likely to initiate alcohol and smokeless tobacco, and had greater total risk factors for alcohol use. These findings indicate the need to establish eligibility requirements, conduct aggressive recruitment and follow-up to minimize subject attrition, and establish programming that targets students not recruited or retained when using standard protocols

Planning strategies for the avoidance of pitfalls in intervention research

Article

Aug 2001
J ADV NURS

Background: With the exception of large clinical trials, few studies in nursing and other social sciences test interventions. The discipline of nursing needs to maintain a full range of research designs for continued knowledge development. Intervention research presents unique opportunities and challenges for the novice as well as the seasoned researcher. Some of these methodological challenges include the complex nature of human subjects and interventions, including many factors that interfere with the study variables. Preliminary studies often reveal challenges that may not always be predicted or reflected in research texts. These challenges may be as important as the study results for success in future research efforts. Purpose: Difficulties encountered in intervention research and suggested strategies for maintaining the integrity of the study are addressed. These challenges include maintaining an adequate sample size, intervention demands, measuring variables, timing issues, and experiencing unexpected events. Findings and conclusions: Strategies presented include the importance of extensive planning, minimizing subject expectations and rewarding efforts, attention to control group members, incorporating retention strategies, expanding knowledge of variables and the study population, preliminary studies as well as anticipating unexpected events. The need for enhanced communication among nurse researchers, educators and clinicians is addressed. In the current health care arena, nurse researchers must understand organizational dynamics and marketing strategies. Collaborative research efforts can increase the visibility of nursing research as well as funding opportunities.

High retention rates within a prospective study of heroin users

Article

Aug 1991

The process of achieving a high retention rate of subjects in a 12-month prospective study of intravenous heroin users in Sydney, Australia is presented. Self-referred heroin users were compared with heroin users from a court diversion programme. The retention rates throughout the prospective study interview schedules were high, ranging from 69 to 83% of the original sample. No statistical differences were detected between the proportions located at each interview, indicating a high retention rate was maintained despite the passage of time. It is argued that contact with State services, i.e. Methadone Maintenance Programmes and the legal system, particularly the prison service, contributed to this high maintenance. It is speculated that the effectiveness of location strategies reflect prominent characteristics of the populations studied.

Longitudinal Research Strategies: Advantages, Problems, and Prospects

Article

Jun 1991
J AM ACAD CHILD PSY

David P. Farrington

The single-cohort, long-term longitudinal survey has many advantages in comparison with a cross-sectional survey in advancing knowledge about offending and other types of psychopathology, notably in providing information about onset and desistance, about continuity and prediction, and about within-individual change. However, the longitudinal survey also has significant problems, notably in confounding aging and period effects, delayed results, achieving continuity in funding and research direction, and cumulative attrition. This paper suggests the use of a multiple-cohort sequential strategy (the "accelerated longitudinal design") as a way of achieving the benefits of the longitudinal method while minimizing the problems in advancing knowledge about the natural history, causes, prevention, and treatment of psychopathological disorders.

A trial that failed, and the reasons why: Comparing the Minnesota model with outpatient treatment and non-treatment for alcohol disorders

Article

Oct 1990
Scand J Soc Med

Longitudinal studies: Social and psychological factors

Article

Feb 1989
REV EPIDEMIOL SANTE

E A Sand

In spite of the great variety of longitudinal studies, one may consider two main orientations: on one hand the "comprehensive" studies, based on the combined or parallel observation of numerous psychosocial characteristics collected at successive stages of the child's development; on the other hand, studies focussed on limited topics based on the observation and longitudinal analysis of a restricted number of specific characteristics. Some examples of these different approaches are presented. The chapter considers, finally, several methodological issues, including new developments as well as constraints and problems. Recent methodological developments concern, i.a., videoscopic recording techniques which may be applied to the behaviour of mother and child (etc...) whether in the laboratory or in normal life-situations. Moreover, in view of the statistical analysis of the datas appropriate instruments are developed which at the same time keep the nuances and details of the clinical observation. Finally, some examples of problems linked to the attrition-rate of the observed sample are presented, as well as specific ethical issues raised by longitudinal studies.

Enhancement of visit adherence in the National Beta-Blocker Heart Attack Trial

Article

Jul 1985
Contr Clin Trials

Efforts were made in the Beta Blocker Heart Trial (BHAT), a double-blind study of 3837 post-MI patients, to enhance visit adherence, a measure of compliance that is not subjective and can be easily monitored. Of the required visits, 93.9% were completed in the window, 3.9% of the patients were classified as dropouts and 12 persons were lost to follow-up. Methods used to enhance compliance varied with circumstances but included appointment reminders, assistance with transportation, minimal waiting times, newsletters, continuity of care, involvement of family members, and close contact with private physicians. Comparisons of the BHAT visit adherence rates to those from other clinical trials are difficult to make because there are few reports in the literature regarding follow-up in large multicenter clinical trials. However, data obtained through personal communications, as well as published reports, indicate that adherence in primary prevention trials was generally less than that of secondary prevention trials. Adherence rates in the BHAT tended to be slightly higher than those of comparable trials.

Obtaining follow-up interviews for treatment evaluation

Article

Mar 1995
J SUBST ABUSE TREAT

Studies of the outcomes of substance abuse treatment are often handicapped because of subjects lost to follow-up. While follow-up data may be obtained from several sources, the follow-up interview often serves as the principal source of data. Difficulties are regularly encountered in locating and interviewing subjects not in treatment. From review of the literature on follow-up methodology and our own experience, we identified 10 procedures for effective follow-up. Application of these procedures is illustrated in a follow-up study of illicit opioid users treated in a methadone maintenance program. Follow-up interviews were obtained with 98% of the subjects. We recommend use of the 10 procedures by follow-up researchers, and we also recommend review of several previous publications on follow-up methodology.

The Multicenter AIDS Cohort Study: Retention after 9 1/2 years

Article

Sep 1995
AM J EPIDEMIOL

In a longitudinal, multicenter study of 4,954 men at risk for human immunodeficiency virus infection and acquired immunodeficiency syndrome, data from the first 9.5 years of follow-up (April 1984 through September 1993) were used to determine differences between those who remained in the study and those who dropped out. Demographic variables (age, race, education, employment, and study center), health status (human immunodeficiency virus type 1 serostatus and depression), and behavioral characteristics (alcohol drinking, drug use, and anal-receptive intercourse) were analyzed. Strategies for promoting retention included having frequent contact with participants, generating trust, keeping participants well-informed, utilizing multiple resources for follow-up, and providing flexible methods of participation. After 9.5 years of follow-up, vital status was known for 4,385 (88.5%) of the participants. Results from multiple logistic regression showed that race, age, education, and smoking were each significantly associated with nonparticipation (p < 0.001). A high level of retention was maintained in this well-educated and highly motivated cohort of homosexual/bisexual men. Extensive follow-up methods may improve case-finding. Nonwhite race, younger age, less education, and smoking were important predictors of dropping out. These findings identify specific groups for targeting follow-up efforts to reduce potential bias due to dropout.

Retention of Resistant Subjects in Longitudinal Studies: Description and Procedures

Article

Feb 1994

This paper discusses efforts to retain resistant subjects (N = 88) in a prospective research project which investigates the effects of prenatal substance use on pregnancy and infant outcome. Resistant subjects were women for whom we had valid addresses and/or phone numbers. They did not refuse to participate but were reluctant to schedule appointments and/or keep scheduled appointments. The persistent resistance we encountered led us to develop procedures which established and maintained rapport with resistant respondents and facilitated access to the 18-month assessment. No significant differences were found between the resistant participants and nonresistant subjects on six sociodemographic factors and on substance use. However, resistant subjects were significantly more depressed than nonresistant subjects. Anxiety and hostility did not differ at any time point. Resistant subjects who were finally interviewed, reported a significantly higher number of recent life events than nonresistant subjects at the 18-month postpartum interview. The follow-up rates for retaining the 88 resistant subjects were 44.3, 72.7, and 79.6% at Phases 4, 5. and 6, respectively.

Recruitment and Retention of Families in Clinical Trials with Longitudinal Designs

Article

Jul 1997

The Family Home Visitation Program: Nurse as Coach was a 3-year, National Cancer Institute-funded, multisite, randomized trial of a nursing intervention. It tested the effectiveness of an in-home coaching intervention designed to enhance long-term adjustment of breast cancer's effect on family functioning. We summarize our recruitment and retention experiences, review accrual and retention issues identified from our experiences and those of other researchers, and suggest 24 specific strategies to maximize sample size in future clinical trial studies. Our target sample consisted of 200 women with early stage breast cancer and their male partners and children. We obtained 313 eligible referrals from 91 sites: 217 participants (69.3%) were accrued, 96 families (30.7%) refused, 181 participants (83.4%) were retained, 11 (5.1%) were dropped because of changes in eligibility status or because of scheduling error, and another 25 (11.5%) elected to withdraw.

Adherence in AIDS clinical trials: A framework for clinical research and clinical care

Article

May 1997
J CLIN EPIDEMIOL

Assessment of adherence within AIDS clinical trials is a critical component of the successful evaluation of therapeutic outcomes. Poor medication adherence can result in the misinterpretation of clinical trial data. Research on factors affecting adherence in AIDS clinical trials has been scarce, and few investigations have evaluated strategies for enhancing patient participation. One reason may be the absence of a conceptual framework to guide research. Consistent with previous research on medical adherence, we propose a framework whereby factors affecting adherence in AIDS clinical trials can be categorized as characteristics of the: (a) individual, (b) treatment regimen, (c) patient-provider relationship, (d) clinical setting, and (e) disease. This framework is used as a heuristic for reviewing studies that examine factors affecting adherence in AIDS clinical trials. Suggestions for future research and clinical intervention are provided. These efforts are timely because adherence is now the center of attention in discourse about the efficacy of the new class of protease inhibitor drugs; non-adherence has been linked to viral resistance and drug failure. Efforts to identify factors that influence adherence to AIDS clinical trials can inform future attempts to improve adherence and retention. Better adherence protects the scientific integrity of AIDS clinical trials, promoting more efficient and accurate evaluations of therapeutic value. Accelerated access to new treatments may follow, ultimately enhancing patient care.

Testing for treatment difference with dropouts present in clinical trials—A composite approach

Article

Jun 1997

A major problem in the analysis of clinical trials is missing data from patients who drop out of the study before the predetermined schedule. In this paper we consider the situation where the outcome measure is a continuous variable and the final outcome at the end of the study is the main interest. We argue that the hypothetical complete-data marginal mean averaged over the dropout patterns is not as relevant clinically as the conditional mean of the completers together with the probability of completion or dropping out of the trial. We first take the pattern-mixture modelling approach to factoring the likelihood function, then direct the analysis to the multiple testings of a composite of hypotheses that involves the probability of dropouts and the conditional mean of the completers. We review three types of closed step-down multiple-testing procedures for this application. Data from several clinical trials are used to illustrate the proposed approach.

Problems and Solutions in Longitudinal Research: From Theory to Practice

Article

Aug 1997

Longitudinal studies provide the only method for directly studying the natural course of human growth and development and are therefore invaluable, both to public health and clinical medicine. However, longitudinal studies are accompanied by specific problems. The purpose of this final paper is to discuss in two separate sections some of the methodological, analytical and practical issues regarding the relevance of the findings reported. Examples of such problems and their solutions are described. Methodological issues discussed concern statistical conclusion validity, internal validity and construct validity of longitudinal studies. Practical issues discussed concern the design of longitudinal studies, the recruitment and retention of subjects, and the methods used. Finally, examples of the significance of longitudinal research outcomes to public health and clinical medicine are given.

Retaining and Tracking Cohort Study Members

Article

Feb 1998

The only way to ensure that losses to follow-up have not biased study results is to keep all losses to an absolute minimum. Since more complete follow-up leads to the identification of additional disease events, the effort spent in locating cohort members also improves the precision as well as the validity of the study results. This presentation reviewed approaches for maximizing retention and minimizing loss to follow-up, including the importance of communicating the expectations of participation and collecting personal information at baseline, conducting frequent personal and mail contact, and providing incentives for participation. Response rates can be increased by repeated attempts to contact each cohort member using a range of approaches (e.g., telephone, mail, personal contacts) and by other procedures specific to mailed questionnaires, telephone interviews, or in-person visits. Lost participants can be traced by use of the NCOA system and contact with other local, state, and national sources. Finally, for those participants who are unable or unwilling to continue or who cannot be found, proxy interviews and/or use of the National Death Index may provide information on the outcomes of interest and vital status. Additional research evaluating the efficacy of the various approaches to retention and tracking is needed to help investigators learn how to best apply study resources to retain and keep track of the largest possible number of cohort members.

Methods of Ensuring High Follow-up Rates: Lessons from a Longitudinal Study of Dual Diagnosed Participants

Article

Dec 1998

Despite growing research interest in co-occurring psychiatric and substance misuse disorders, relatively few longitudinal studies have been conducted with dual diagnosis populations. Many of the longitudinal studies that have been done have experienced excessive attrition. Thus, investigators have noted that one of the primary difficulties of conducting longitudinal studies with this population is successfully minimizing attrition during follow-up. This study, conducted in 1991 1993, describes retention and tracking methods employed in a longitudinal study of 485 dual diagnosis participants. Follow-up interview completion rates at the 2-, 6-, 10-, 14-, and 18-month interviews were 86.7, 85.6, 85.1, 84.5, and 88.4%, respectively. Several case studies are provided that document some of the challenges facing project staff and successful strategies for handling them. A notable finding from this study was that participants reported that the relationship established with the interviewer was more important than material incentives in preventing study attrition.

The Art of Clinical Management in Pharmacologic Trials With Depressed Elderly Patients: Lessons from the Pittsburgh Study of Maintenance Therapies in Late-Life Depression

Article

Feb 1999
AM J GERIAT PSYCHIAT

Systematic review identifies number of strategies important for retaining study participants

Abstract

No full-text available