Recruiting young women of color into a pilot RCT targeting sexual health: Lessons learned and implications for applied health technology research.
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ABSTRACT:
SUBMITTER: Gonzalez SK
PROVIDER: S-EPMC7606544 | biostudies-literature |
REPOSITORIES: biostudies-literature
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| S-EPMC4660345 | biostudies-literature
Project description:BackgroundHealth economists have shown a growing interest in deliberation and multi-criteria decision analysis (MCDA) as possible pathways to transparently integrate value judgments in cost-utility analyses. In line with these developments, this study piloted a consensus process to derive a German value set for the Short-Form Six-Dimension (SF-6D). In a conference setting, a group was tasked to deliberate on scores and weights for the SF-6D from the perspective of a self-determined and independent life.MethodsThe one-day consensus conference was based on a deliberative process in combination with the MCDA method MACBETH (Measuring Attractiveness by a Categorical Based Evaluation Technique). According to MACBETH, participants were asked to qualitatively rate pairwise comparisons of SF-6D health states. The scoring within each dimension was conducted in parallel group sessions. Final agreement on the scores as well as weights for the SF-6D dimensions were derived in a subsequent plenary assembly. Results were analyzed using the software M-MACBETH and qualitative content analysis.ResultsA total of 34 participants were recruited. While each of the 6 small groups presented a consented score, the plenary assembly reached consensus on all dimensions apart from pain. Concerning dimension weights, some participants favored prioritizing pain and mental health. Others disputed that trade-offs between dimensions and thus assigning weights were not acceptable in a context where this may involve withholding care from someone. As a consequence, no consensus on a value set was reached. Participants identified the group size of the plenary session and the applied weighting procedure as main obstacles to the process.ConclusionsThis pilot study presents a consensus-based approach for valuing health-related quality of life. However, further research is needed on deliberative processes that yield quantifiable results. Future conferences should explore smaller group sizes, longer durations of the deliberative process and alternatives to the additive value function applied in MACBETH.
| S-EPMC6604444 | biostudies-literature
Project description:While COVID-19 is still ongoing and associated with more than 5 million deaths, the scope and speed of advances over the past year in terms of scientific discovery, data dissemination, and technology have been staggering. It is not a matter of "if" but "when" we will face the next pandemic, and how we leverage technology and data management effectively to create flexible ecosystems that facilitate collaboration, equitable care, and innovation will determine its severity and scale. The aim of this review is to address emerging challenges that came to light during the pandemic in health care and innovations that enabled us to adapt and continue to care for patients. The pandemic highlighted the need for seismic shifts in care paradigms and technology with considerations related to the digital divide and health literacy for digital health interventions to reach full potential and improve health outcomes. We discuss advances in telemedicine, remote patient monitoring, and emerging wearable technologies. Despite the promise of digital health, we emphasise the importance of addressing its limitations, including interpretation challenges, accuracy of findings, and artificial intelligence-driven algorithms. We summarise the most recent recommendation of the Virtual Care Task Force to scaling virtual medical services in Canada. Finally, we propose a model for optimal implementation of health digital innovations with 5 tenets including data management, data security, digital biomarkers, useful artificial intelligence, and clinical integration.
| S-EPMC8632798 | biostudies-literature
Project description:Background: Hospitalizations for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are associated with increased mortality and decreased quality of life. Replicate hospital discharge studies were initiated to examine efficacy and safety of once-daily tiotropium HandiHaler® versus placebo, in addition to usual care, in patients discharged from the hospital after an AECOPD. Methods: Both studies were randomized, placebo-controlled, double-blind, parallel-group, multicenter, with inclusion/exclusion criteria providing a diverse COPD patient cohort hospitalized for ?14 days with AECOPD. Patients received tiotropium or placebo, initiated within 10 days post-discharge. Target recruitment was 604 patients/study and planned duration was event-driven, ending after 631 clinical outcome events across both studies. Inability to reach targeted site numbers and patient recruitment/retention difficulties led to early study termination. Recruitment/retention challenges and protocol amendment impacts were assessed qualitatively to understand the major issues. Results: Over 18 months, 219 patients were enrolled; 158 were randomized and 61 failed screening. Premature treatment discontinuation occurred in 49(31%) patients, of whom 20(41%) completed health status follow-up. All-cause, 30-day hospital readmission was low (8[5%] patients). A total of 154(98%) patients had a concomitant diagnosis and most took pulmonary medication pre-randomization (143[91%]) and during study treatment (144[92%]). Inclusion/exclusion criteria changes failed to improve recruitment. Recruitment/retention barriers were identified, relating to patient and clinician factors, health care infrastructure, and clinical practices. Conclusions: Although AECOPD hospitalization is clinically important and incurs high costs, significant challenges exist in studying this population in clinical trials after hospitalization. Studies are needed to evaluate effective management of AECOPD patients at high risk of adverse clinical outcomes.
| S-EPMC5764840 | biostudies-literature
Project description:The Building Up Trial is a cluster-randomized trial that aims to address the issue of the leaky career pathway for underrepresented (UR) faculty in biomedical fields. Regulatory approval and recruitment for the Building Up Trial took place during the COVID-19 pandemic and the anti-racism movement. The pandemic and anti-racism movement personally and professionally impacted the target population and made recruitment challenging at both the institution and participant level. The target sample size for this study was 208 postdoctoral fellows or early-career faculty across 26 predominately white institutions. Challenges and adaptations are described. The Building Up Trial was delayed by 3 months. In total, 225 participants from 26 institutions were enrolled. Participants are predominately female (80%), Hispanic/Latinx (34%) or non-Hispanic/Latinx Black (33%), and early-career faculty (53%). At the institution level, obtaining Institutional Review Board (IRB) approval through a single Institutional Review Board (sIRB) posed the biggest challenge. We adapted to COVID-19-related challenges through simplifying sIRB forms, modifying study practices, and increasing communication with institutions. Recruiting UR postdoctoral fellows and faculty during the COVID-19 pandemic and anti-racism movement was challenging but not impossible. Studies should be prepared to modify study and recruitment policies to overcome additional barriers posed by the pandemics.
| S-EPMC8596076 | biostudies-literature
Project description:The use of remote measurement technologies (RMTs) across mobile health (mHealth) studies is becoming popular, given their potential for providing rich data on symptom change and indicators of future state in recurrent conditions such as major depressive disorder (MDD). Understanding recruitment into RMT research is fundamental for improving historically small sample sizes, reducing loss of statistical power, and ultimately producing results worthy of clinical implementation. There is a need for the standardisation of best practices for successful recruitment into RMT research. The current paper reviews lessons learned from recruitment into the Remote Assessment of Disease and Relapse- Major Depressive Disorder (RADAR-MDD) study, a large-scale, multi-site prospective cohort study using RMT to explore the clinical course of people with depression across the UK, the Netherlands, and Spain. More specifically, the paper reflects on key experiences from the UK site and consolidates these into four key recruitment strategies, alongside a review of barriers to recruitment. Finally, the strategies and barriers outlined are combined into a model of lessons learned. This work provides a foundation for future RMT study design, recruitment and evaluation.
| S-EPMC9440458 | biostudies-literature
Project description:BackgroundTransgender men (TGM) are underrepresented in genital microbiome research. Our prospective study in Birmingham, AL investigated genital microbiota changes over time in TGM initiating testosterone, including the development of incident bacterial vaginosis (iBV). Here, we present lessons learned from recruitment challenges encountered during the conduct of this study.MethodsInclusion criteria were assigned female sex at birth, TGM or non-binary identity, age ≥18 years, interested in injectable testosterone but willing to wait 7 days after enrollment before starting, and engaged with a testosterone-prescribing provider. Exclusion criteria were recent antibiotic use, HIV/STI infection, current vaginal infection, pregnancy, or past 6 months testosterone use. Recruitment initiatives included community advertisements via flyers, social media posts, and referrals from local gender health clinics.ResultsBetween February 2022 and October 2023, 61 individuals contacted the study, 17 (27.9%) completed an in-person screening visit, and 10 (58.8%) of those screened were enrolled. The primary reasons for individuals failing study screening were having limited access to testosterone-prescribing providers, already being on testosterone, being unwilling to wait 7 days to initiate testosterone therapy, or desiring the use of topical testosterone. Engagement of non-White TGM was also minimal.ConclusionDespite robust study inquiry by TGM, screening and enrollment challenges were faced including engagement by TGM not yet in care and specific study eligibility criteria. Excitement among TGM for research representation should be leveraged in future work by engaging transgender community stakeholders at the inception of study development, particularly regarding feasibility of study inclusion and exclusion criteria, as well as recruitment of TGM of color. These results also highlight the need for more clinical resources for prescribing gender-affirming hormone therapy, especially in the Southeastern US.
| S-EPMC11318884 | biostudies-literature
Project description:The main purpose of the current trial was to test if a brief trauma-focused cognitive-behaviour therapy protocol (prolonged exposure; PE) provided within 72 h after a traumatic event could be effective in decreasing the incidence of post-traumatic stress disorder (PTSD), thus replicating and extending the findings from an earlier trial. After a pilot study (N = 10), which indicated feasible and deliverable study procedures and interventions, we launched an RCT with a target sample size of 352 participants randomised to either three sessions of PE or non-directive support. Due to an unforeseen major reorganisation at the hospital, the RCT was discontinued after 32 included participants. In this paper, we highlight obstacles and lessons learned from our feasibility work that are relevant for preventive psychological interventions for PTSD in emergency settings. One important finding was the high degree of attrition, and only 75% and 34%, respectively, came back for the 2-month and 6-month assessments. There were also difficulties in reaching eligible patients immediately after the event. Based on our experiences, we envisage that alternative models of implementation might overcome these obstacles, for example, with remote delivery of both assessments and interventions via the internet or smartphones combined with multiple recruitment procedures. Lessons learned from this terminated RCT are discussed in depth.
| S-EPMC8143412 | biostudies-literature
Project description:BackgroundRecruiting large samples of diverse sexual and gender minority adolescent and young adults (AYAs) into HIV intervention research is critical to the development and later dissemination of interventions that address the risk factors for HIV transmission among substance-using, sexual and gender minority AYAs.ObjectiveThis paper aimed to describe the characteristics of the samples recruited via social media and in-person methods and makes recommendations for strategies to recruit substance-using, sexual and gender minority AYAs, a hardly reached population that is a priority for HIV prevention research.MethodsUsing data from a randomized control trial of an HIV and substance use intervention with sexual and gender minority AYAs, aged 15 to 29 years in southeastern Michigan (n=414), we examined demographic and behavioral characteristics associated with successful recruitment from a range of virtual and physical venues.ResultsWe found that paid advertisements on Facebook, Instagram, and Grindr offered the largest quantity of eligible participants willing to enroll in the trial. Instagram offered the largest proportion of transgender masculine participants, and Grindr offered the largest proportion of Black/African American individuals. Although we attempted venue-based recruitment at clubs, bars, community centers, and AIDS service organizations, we found it to be unsuccessful for this specific hardly reached population. Social media and geobased dating applications offered the largest pool of eligible participants.ConclusionsUnderstanding factors associated with successful recruitment has the potential to inform effective and efficient strategies for HIV prevention research with substance-using, sexual and gender AYAs.Trial registrationClinicalTrials.gov NCT02945436; https://clinicaltrials.gov/ct2/show/NCT02945436.International registered report identifier (irrid)RR2-10.2196/resprot.9414.
| S-EPMC8686481 | biostudies-literature
Project description:BACKGROUND:Providing financial incentives has gained popularity as a strategy to promote weight loss, but questions remain about how best to utilize them. A promising mobile health strategy provides users with near-real-time financial incentives based on both the process of weight loss (behavioral modification) and actual weight loss. To maximize the impact of this strategy, a methodology is needed to close the gap between the desired behavior and the financial incentive. Leveraging mobile health tools-such as mobile phone apps, cellular body weight scales that transmit data to physicians and researchers, and text messaging for instructions and encouragement-has the potential to close this gap. OBJECTIVE:This study aimed to describe the development of an innovative technology-based solution and lessons learned from a feasibility trial-Log2Lose-that encouraged individuals to lose weight by providing near-real-time financial incentives for weight loss and/or dietary self-monitoring. METHODS:We recruited participants (N=96) with a body mass index greater than or equal to 30 kg/m2 for a 24-week weight loss trial. Participants received a behavioral intervention of biweekly, in-person group sessions and were instructed to log a minimum number of daily calories in MyFitnessPal and to step on the BodyTrace cellular scale at least twice per week. In a 2×2 design, participants were randomized into 4 groups to receive financial incentives for the following: (group 1) weekly weight loss and dietary self-monitoring, (group 2) dietary self-monitoring only, (group 3) weekly weight loss only, or (group 4) no financial incentives. Diet and weight data from the devices were obtained through application programming interfaces. Each week, we applied algorithms to participants' data to determine whether they qualified for a monetary incentive (groups 1-3). A text message notified these participants of whether they met weight loss and/or self-monitoring requirements to earn an incentive and the amount they earned or would have earned. The money was uploaded to a debit card. RESULTS:Our custom-engineered software platform analyzed data from multiple sources, collated and processed the data to send appropriate text messages automatically, and informed study staff of the appropriate incentives. We present lessons learned from the development of the software system and challenges encountered with technology, data transmission, and participants (eg, lost connections or delayed communication). CONCLUSIONS:With consistent and constant validation checks and a robust beta test run, the process of analyzing data and determining eligibility for weekly incentives can be mostly automated. We were able to accomplish this project within an academic health system, which required significant security and privacy safeguards. Our success demonstrates how this methodology of automated feedback loops can provide health interventions via mobile technology. TRIAL REGISTRATION:ClinicalTrials.gov NCT02691260; https://clinicaltrials.gov/ct2/show/NCT02691260.
| S-EPMC6391641 | biostudies-literature