Financial management of a large multisite randomized clinical trial.
Ontology highlight
ABSTRACT:
SUBMITTER: Sheffet AJ
PROVIDER: S-EPMC4107123 | biostudies-literature | 2014 Aug
REPOSITORIES: biostudies-literature
Publications
Financial management of a large multisite randomized clinical trial.
Sheffet Alice J AJ Flaxman Linda L Tom MeeLee M Hughes Susan E SE Longbottom Mary E ME Howard Virginia J VJ Marler John R JR Brott Thomas G TG
International journal of stroke : official journal of the International Stroke Society 20140324 6
<h4>Background</h4>The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years' funding ($21 112 866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2500 randomized participants at 40 sites.<h4>Aims</h4>Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials.<h4>Methods</h4>Projections of the ...[more]
Similar Datasets
Project description:ObjectiveTo determine the efficacy in improving pain and health-related quality of life (HRQOL) of an online self-management program for adolescents with juvenile idiopathic arthritis (JIA).MethodsYouth ages 12-18 years with JIA were recruited from 10 rheumatology clinics across the United States and randomized to complete an online self-management program (n = 144) or an online disease education program (n = 145). Participants in the self-management group worked through multimedia-based modules comprising psychoeducation, training in cognitive-behavioral coping skills and stress management, and other self-management topics over a 12-week period. Participants in the control group viewed a series of preselected quality educational websites about JIA over the same interval. Online content for both groups was made available in English and Spanish to facilitate inclusion of Hispanic participants. Blinded assessment of main outcomes (pain intensity, pain interference, and HRQOL) and process outcomes (disease knowledge, self-efficacy, pain coping, and emotional adjustment) occurred at baseline, posttreatment, and at 6- and 12-month postrandomization follow-up visits.ResultsParticipants on average demonstrated significant improvements over the study period in the main outcomes, with no significant group differences in the degree of improvement. Effect sizes for these improvements were small. The amount of improvement in self-efficacy, emotional avoidance coping, disease knowledge, and emotional functioning in part predicted improvement in pain and HRQOL outcomes.ConclusionsPrimarily self-directed online self-management training and online disease education comparably and modestly improve pain and HRQOL in youth with JIA.
| S-EPMC6415659 | biostudies-literature
Project description:ObjectiveThe purpose of this study was to evaluate the effects of a mobile app designed to improve chronic disease self-management in older adult patients with low health literacy and who had at least one chronic health condition, and to assess the impact of delivering information at different levels of reading difficulty.MethodsA randomized controlled trial was completed at two sites. Individuals 40 years of age and older screened for low health literacy who had at least one chronic health condition were randomly assigned to a tailored information multimedia app with text at one of three grade levels. Four primary outcomes were assessed: patient activation, chronic disease self-efficacy, health-related quality of life, and medication adherence.ResultsAll groups showed overall increases in activation, self-efficacy, and health-related quality of life, but no change in medication adherence. No between-group differences were observed.ConclusionsThe mobile app was effective in increasing participants' levels of several psychosocial variables, but reading difficulty level was not significantly related to outcomes.Registered at clinicaltrials.gov NCT02922439.
| S-EPMC10104214 | biostudies-literature
Project description:Importance:Although breastfeeding has a positive effect on an infant's health and development, the prevalence is low in many communities. The effect of financial incentives to improve breastfeeding prevalence is unknown. Objective:To assess the effect of an area-level financial incentive for breastfeeding on breastfeeding prevalence at 6 to 8 weeks post partum. Design, Setting, and Participants:The Nourishing Start for Health (NOSH) trial, a cluster randomized trial with 6 to 8 weeks follow-up, was conducted between April 1, 2015, and March 31, 2016, in 92 electoral ward areas in England with baseline breastfeeding prevalence at 6 to 8 weeks post partum less than 40%. A total of 10?010 mother-infant dyads resident in the 92 study electoral ward areas where the infant's estimated or actual birth date fell between February 18, 2015, and February 17, 2016, were included. Areas were randomized to the incentive plus usual care (n?=?46) (5398 mother-infant dyads) or to usual care alone (n?=?46) (4612 mother-infant dyads). Interventions:Usual care was delivered by clinicians (mainly midwives, health visitors) in a variety of maternity, neonatal, and infant feeding services, all of which were implementing the UNICEF UK Baby Friendly Initiative standards. Shopping vouchers worth £40 (US$50) were offered to mothers 5 times based on infant age (2 days, 10 days, 6-8 weeks, 3 months, 6 months), conditional on the infant receiving any breast milk. Main Outcomes and Measures:The primary outcome was electoral ward area-level 6- to 8-week breastfeeding period prevalence, as assessed by clinicians at the routine 6- to 8-week postnatal check visit. Secondary outcomes were area-level period prevalence for breastfeeding initiation and for exclusive breastfeeding at 6 to 8 weeks. Results:In the intervention (5398 mother-infant dyads) and control (4612 mother-infant dyads) group, the median (interquartile range) percentage of women aged 16 to 44 years was 36.2% (3.0%) and 37.4% (3.6%) years, respectively. After adjusting for baseline breastfeeding prevalence and local government area and weighting to reflect unequal cluster-level breastfeeding prevalence variances, a difference in mean 6- to 8-week breastfeeding prevalence of 5.7 percentage points (37.9% vs 31.7%; 95% CI for adjusted difference, 2.7% to 8.6%; P?<?.001) in favor of the intervention vs usual care was observed. No significant differences were observed for the mean prevalence of breastfeeding initiation (61.9% vs 57.5%; adjusted mean difference, 2.9 percentage points; 95%, CI, -0.4 to 6.2; P?=?.08) or the mean prevalence of exclusive breastfeeding at 6 to 8 weeks (27.0% vs 24.1%; adjusted mean difference, 2.3 percentage points; 95% CI, -0.2 to 4.8; P?=?.07). Conclusions and Relevance:Financial incentives may improve breastfeeding rates in areas with low baseline prevalence. Offering a financial incentive to women in areas of England with breastfeeding rates below 40% compared with usual care resulted in a modest but statistically significant increase in breastfeeding prevalence at 6 to 8 weeks. This was measured using routinely collected data. Trial Registration:International Standard Randomized Controlled Trial Registry: ISRCTN44898617.
| S-EPMC5839268 | biostudies-literature
Project description:The effectiveness of cognitive remediation therapy (CRT) for the neuropsychological deficits seen in schizophrenia is supported by meta-analysis. However, a recent methodologically rigorous trial had negative findings. In this study, 130 chronic schizophrenic patients were randomly assigned to computerized CRT, an active computerized control condition (CC) or treatment as usual (TAU). Primary outcome measures were 2 ecologically valid batteries of executive function and memory, rated under blind conditions; other executive and memory tests and a measure of overall cognitive function were also employed. Carer ratings of executive and memory failures in daily life were obtained before and after treatment. Computerized CRT was found to produce improvement on the training tasks, but this did not transfer to gains on the primary outcome measures and most other neuropsychological tests in comparison to either CC or TAU conditions. Nor did the intervention result in benefits on carer ratings of daily life cognitive failures. According to this study, computerized CRT is not effective in schizophrenia. The use of both active and passive CCs suggests that nature of the control group is not an important factor influencing results.
| S-EPMC4601710 | biostudies-literature
Project description:BackgroundExcessive gestational weight gain (GWG) is common and can result in maternal and child health complications. Pragmatic behavioral interventions that can be incorporated into standard obstetric care are needed, and financial incentives are a promising approach.ObjectiveThe aim of this study is to evaluate the feasibility of recruitment, randomization, and retention, as well as treatment engagement and intervention satisfaction, in a behavioral program. The program provided small incentives for meeting behavioral goals of self-weighing and physical activity as well as larger outcome incentives for meeting GWG goals.MethodsWe recruited 40 adult women in their first trimester of pregnancy from February 2019 to September 2019 at an obstetric clinic. Participants were randomized to 3 intervention components using a 2×2×2 factorial design: daily incentives for self-weighing (lottery vs certain loss), incentives for adhering to the Institute of Medicine's GWG guidelines based on BMI category (monthly vs overall), and incentives for reaching physical activity goals (yes vs no). Participants were asked to complete daily weigh-ins using the Withings Body wireless scale provided by the study, as well as wear a physical activity tracker (Fitbit Flex 2). Feasibility outcomes of recruitment, randomization, and retention, as well as treatment engagement and intervention satisfaction, were assessed. Weight assessments were conducted at baseline, 32-week gestation, and 36-week gestation.ResultsParticipants were enrolled at, on average, 9.6 (SD 1.8) weeks' gestation. Of the 39 participants who were oriented to their condition and received the intervention, 24 (62%) were Black or African American, 30 (77%) were not married, and 29 (74%) had an annual household income of less than US $50,000. Of the 39 participants, 35 (90%) completed the follow-up data collection visit. Participants were generally quite positive about the intervention components, with a particular emphasis on the helpfulness of, and the enjoyment of using, the e-scale in both the quantitative and qualitative feedback. Participants who received the loss incentive, on average, had 2.86 times as many days of self-weighing as those who received the lottery incentive. Participants had a relatively low level of activity, with no difference between those who received a physical activity incentive and those who did not.ConclusionsA financial incentive-based pragmatic intervention was feasible and acceptable for pregnant women for promoting self-weighing, physical activity, and healthy GWG. Participants were successfully recruited early in their first trimester of pregnancy and retained for follow-up data collection in the third trimester. Participants demonstrated promising engagement in self-weighing, particularly with loss-based incentives, and reported finding the self-weighing especially helpful. This study supports further investigation of pragmatic, clinic-based financial incentive-based interventions for healthy GWG behaviors.Trial registrationClinicalTrials.gov NCT03834194; https://clinicaltrials.gov/ct2/show/NCT03834194.
| S-EPMC8742213 | biostudies-literature
Project description:BackgroundFinancial incentives for smoking cessation and use of evidence-based therapy may increase quitting rates and reduce health and economic disparities.MethodsWe randomized a low-income population of 182 hospitalized patients (mean age 58 years, 45% with high school education or less) to enhanced usual care, which included hospital-directed cessation care and Quitline referral or enhanced usual care plus financial incentives. All patients received enhanced usual care, while participants randomized to the financial incentives group were also eligible to receive up to $550 for participation in Quitline counseling ($50), participation in a community-based cessation program ($50), use of pharmacotherapy ($50), and biochemically confirmed smoking cessation at 2 months ($150) and 6 months ($250). Primary outcome was biochemically confirmed smoking cessation at 6 months after hospital discharge.ResultsTotal mean payment was $84 (standard deviation [SD] = $133) in the incentive group. The 6-month rate of biochemically confirmed smoking cessation was 19.6% in the incentive group and 8.9% in the enhanced usual care group (odds ratio [OR] 2.56; 95% confidence interval [CI] 0.84 to 7.83, P = 0.10). Participants in the incentive group had higher rates of nicotine replacement therapy use (57.3% vs 31.3%, P = 0.002). Financial incentives did not improve subjective social status but did increase financial stress.ConclusionsRates of bioconfirmed smoking cessation were higher among hospitalized patients randomized to financial incentives compared to usual care alone, but the difference was not significant. Considering the frequency of low payouts and the importance of assistance for successful quitting, future studies should explore the effectiveness of financial incentives sufficiently large to overcome barriers to evidence-based therapy.
| S-EPMC7293955 | biostudies-literature
Project description:IntroductionCerebral palsy (CP) affects up to 4 children in 1,000 live births, making it the most common motor disorder in children. It impairs the child's ability to move voluntarily and maintain balance and posture, and results in a wide range of other functional disorders during early development impairments in various sensory modalities, e.g., vision, hearing ability and proprioception. Current standard of care therapy focuses on symptom management and does not mitigate the progression of many of these underlying neurological impairments. The goal of this trial is to conduct a prospective multicenter, double-blinded, sham-controlled, crossover, randomized control trial to demonstrate the safety and efficacy of noninvasive spinal cord neuromodulation (SCiP™, SpineX Inc.) in conjunction with activity-based neurorehabilitation therapy (ABNT) to improve voluntary sensorimotor function in children with cerebral palsy.Methods and analysisSixty participants (aged 2-13 years) diagnosed with CP classified as Gross Motor Function Classification Scale Levels I-V will be recruited and divided equally into two groups (G1 and G2). Both groups will receive identical ABNT 2 days/wk. G1 will initially receive sham stimulation, whereas G2 will receive therapeutic SCiP™ therapy for 8 weeks. After 8 weeks, G1 will cross over and receive therapeutic SCiP™ therapy for 8 weeks, whereas G2 will continue to receive SCiP™ therapy for another 8 weeks, for a total of 16 weeks. Primary and secondary outcome measures will include Gross Motor Function Measure-88 and Modified Ashworth Scale, respectively. Frequency and severity of adverse events will be established by safety analyses.Ethics and disseminationThe trial is registered on clinicaltrials.gov (NCT05720208). The results from this trial will be reported on clinicaltrials.gov, published in peer-reviewed journals and presented at scientific and clinical conferences.
| S-EPMC10411340 | biostudies-literature
Project description:ImportanceSocioeconomically disadvantaged individuals (ie, those with low socioeconomic status [SES]) have difficulty quitting smoking and may benefit from incentive-based cessation interventions.ObjectivesTo evaluate the impact of incentivizing smoking abstinence on smoking cessation among adults with low SES.Design, setting, and participantsThis study used a 2-group randomized clinical trial design. Data collection occurred between January 30, 2017, and February 7, 2022. Participants included adults with low SES who were willing to undergo smoking cessation treatment. Data were analyzed from April 18, 2023, to April 19, 2024.InterventionsParticipants were randomized to usual care (UC) for smoking cessation (counseling plus pharmacotherapy) or UC plus abstinence-contingent financial incentives (UC plus FI).Main outcomes and measuresThe primary outcome was biochemically verified 7-day point prevalence smoking abstinence (PPA) at 26 weeks after the quit date. Secondary outcomes included biochemically verified 7-day PPA at earlier follow-ups, 30-day PPA at 12 and 26 weeks, repeated 7-day PPA, and continuous abstinence. Multiple approaches were employed to handle missing outcomes at follow-up, including categorizing missing data as smoking (primary), complete case analysis, and multiple imputation.ResultsThe 320 participants had a mean (SD) age of 48.9 (11.6) and were predominantly female (202 [63.1%]); 82 (25.6%) were Black, 15 (4.7%) were Hispanic, and 200 (62.5%) were White; and 146 (45.6%) participated during the COVID-19 pandemic. Overall, 161 were randomized to UC and 159 were randomized to UC plus FI. After covariate adjustment with missing data treated as smoking, assignment to UC plus FI was associated with a greater likelihood of 7-day PPA at the 4-week (adjusted odds ratio [AOR], 3.11 [95% CI, 1.81-5.34]), 8-week (AOR, 2.93 [95% CI, 1.62-5.31]), and 12-week (AOR, 3.18 [95% CI, 1.70-5.95]) follow-ups, but not at the 26-week follow-up (22 [13.8%] vs 14 [8.7%] abstinent; AOR, 1.79 [95% CI, 0.85-3.80]). However, the association of group assignment with smoking cessation reached statistical significance at all follow-ups, including 26 weeks, with multiple imputation (37.37 [23.5%] in the UC plus FI group vs 19.48 [12.1%] in the UC group were abstinent; AOR, 2.29 [95% CI, 1.14-4.63]). Repeated-measures analyses indicated that participants in the UC plus FI group were significantly more likely to achieve PPA across assessments through 26 weeks with all missing data estimation methods. Other secondary cessation outcomes also showed comparable patterns across estimation methods. Participants earned a mean (SD) of $72 ($90) (of $250 possible) in abstinence-contingent incentives. Participation during the COVID-19 pandemic reduced the likelihood of cessation across assessments.Conclusions and relevanceIn this randomized clinical trial, incentivizing smoking cessation did not increase cessation at 26 weeks when missing data were treated as smoking; however, the UC plus FI group had greater odds of quitting at follow-ups through 12 weeks. Cessation rates were higher for the UC plus FI group at all follow-ups through 26 weeks when multiple imputation was used to estimate missing outcomes.Trial registrationClinicalTrials.gov Identifier: NCT02737566.
| S-EPMC11220567 | biostudies-literature
Project description:Uptake of human papillomavirus (HPV) vaccinations by 17- to 18-year-old girls in England is below (<35%) target (80%). This trial assesses (a) the impact of financial incentives on uptake and completion of an HPV vaccination program, and (b) whether impacts are moderated by participants' deprivation level. It also assesses the impact of incentives on decision quality to get vaccinated, as measured by attitudes toward the vaccination and knowledge of its consequences.One thousand 16- to 18-year-old girls were invited to participate in an HPV vaccination program: 500 previously uninvited, and 500 unresponsive to previous invitations. Girls randomly received either a standard invitation letter or a letter including the offer of vouchers worth £ 45 (€ 56; $73) for undergoing 3 vaccinations. Girls attending their first vaccination appointment completed a questionnaire assessing decision quality to be vaccinated. Outcomes were uptake of the first and third vaccinations and decision quality.The intervention increased uptake of the first (first-time invitees: 28.4% vs. 19.6%, odds ratio [OR] = 1.63, 95% confidence interval [CI; 1.08, 2.47]; previous nonattenders: 23.6% vs. 10.4%, OR = 2.65, 95% CI [1.61, 4.38]) and third (first-time invitees: 22.4% vs. 12%, OR = 2.15, 95% CI [1.32, 3.50]; previous nonattenders: 12.4% vs. 3%, OR = 4.28, 95% CI [1.92, 9.55]) vaccinations. Impacts were not moderated by deprivation level. Decision quality was unaffected by the intervention.Although the intervention increased completion of HPV vaccinations, uptake remained lower than the national target, which, in addition to cost effectiveness and acceptability issues, necessitates consideration of other ways of achieving it.
| S-EPMC4312136 | biostudies-other
Project description:ImportanceLarge language model (LLM) artificial intelligence (AI) systems have shown promise in diagnostic reasoning, but their utility in management reasoning with no clear right answers is unknown.ObjectiveTo determine whether LLM assistance improves physician performance on open-ended management reasoning tasks compared to conventional resources.DesignProspective, randomized controlled trial conducted from 30 November 2023 to 21 April 2024.SettingMulti-institutional study from Stanford University, Beth Israel Deaconess Medical Center, and the University of Virginia involving physicians from across the United States.Participants92 practicing attending physicians and residents with training in internal medicine, family medicine, or emergency medicine.InterventionFive expert-developed clinical case vignettes were presented with multiple open-ended management questions and scoring rubrics created through a Delphi process. Physicians were randomized to use either GPT-4 via ChatGPT Plus in addition to conventional resources (e.g., UpToDate, Google), or conventional resources alone.Main outcomes and measuresThe primary outcome was difference in total score between groups on expert-developed scoring rubrics. Secondary outcomes included domain-specific scores and time spent per case.ResultsPhysicians using the LLM scored higher compared to those using conventional resources (mean difference 6.5 %, 95% CI 2.7-10.2, p<0.001). Significant improvements were seen in management decisions (6.1%, 95% CI 2.5-9.7, p=0.001), diagnostic decisions (12.1%, 95% CI 3.1-21.0, p=0.009), and case-specific (6.2%, 95% CI 2.4-9.9, p=0.002) domains. GPT-4 users spent more time per case (mean difference 119.3 seconds, 95% CI 17.4-221.2, p=0.02). There was no significant difference between GPT-4-augmented physicians and GPT-4 alone (-0.9%, 95% CI -9.0 to 7.2, p=0.8).Conclusions and relevanceLLM assistance improved physician management reasoning compared to conventional resources, with particular gains in contextual and patient-specific decision-making. These findings indicate that LLMs can augment management decision-making in complex cases.Trial registrationClinicalTrials.gov Identifier: NCT06208423; https://classic.clinicaltrials.gov/ct2/show/NCT06208423.
| S-EPMC11326321 | biostudies-literature