Financial management of a large multisite randomized clinical trial.
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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]
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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: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: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
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:Importance:Elucidation of optimal dosing and treatment content is critical for health care providers, payers, and policy makers, as well as mechanisms of change to inform intervention delivery and training initiatives for childhood obesity. Objectives:To evaluate effects, following a 4-month family-based behavioral weight loss treatment (FBT), of 2 doses (HIGH or LOW) of a weight-control intervention (enhanced social facilitation maintenance [SFM+]) vs a weight-control education condition (CONTROL; matched for dose with LOW), on child anthropometrics, and to explore putative mediators of weight loss outcomes. Design, Setting, and Participants:For this parallel-group randomized clinical trial conducted at 2 US academic medical centers from December 2009 to March 2013, 172 parent-child dyads completed FBT and were then randomized to 8 months of SFM+ (HIGH, n = 59; LOW, n = 56) or CONTROL (n = 57). Children (aged 7-11 years) with overweight and obesity (body mass index [BMI; calculated as weight in kilograms divided by height in meters squared] ≥85th percentile) with at least 1 parent with overweight and obesity (BMI ≥25) were recruited. Interventions:HIGH SFM+ vs LOW SFM+ (CONTROL matched the dose of LOW). Main Outcomes and Measures:Intention-to-treat analysis using mixed-effects models estimated change in child percentage overweight (percentage above the median BMI for a child's age and sex) for the FBT period (0-4 months) and the SFM+ period (4-12 months), and proportion of children achieving a clinically significant change in percentage overweight (≥9-unit decrease; months 0-12). Theory-based outcome mediators were also evaluated. Results:This study recruited 172 parent-child dyads (mean [SD] age: parents 42.3 [6.4] years; children, 9.4 [1.3] years). The omnibus treatment × time interaction for child percentage overweight was significant (F8, 618.9 = 2.89; P = .004). Planned pairwise comparisons revealed that from months 4 to 12, LOW had better outcomes than CONTROL (difference, -3.34; 95% CI, -6.21 to -0.47; d = -0.40; P = .02). HIGH had better outcomes than LOW (difference, -3.37; 95% CI, -6.15 to -0.59; d = -0.38; P = .02) and CONTROL (difference, -6.71; 95% CI, -9.57 to -3.84; d = -0.77; P < .001). A greater proportion of children in HIGH (45 [82%]) vs LOW (34 [64%]) (difference, 18.00; 95% CI, 1.00-34.00; P = .03; number needed to treat = 5.56) and CONTROL (25 [48%]) (difference, 34.00; 95% CI, 16.00-51.00; P < .001; number needed to treat = 2.94) had clinically significant percentage overweight reductions. Food and activity monitoring and goal setting mediated the effect of LOW vs CONTROL (50%). Monitoring and goal setting, family and home environment, and healthy behaviors with peers mediated the effect of HIGH vs CONTROL (25%-42%). Conclusions and Relevance:Following FBT, specialized intervention content (SFM+) enhanced children's weight outcomes and outperformed a credible control condition, with high dose delivery yielding the best outcomes. Sustained monitoring and goal setting, support from the family and home environment, and healthy peer interactions explained outcome differences, highlighting key treatment targets. Trial Registration:clinicaltrials.gov Identifier: NCT00759746.
| S-EPMC6169780 | biostudies-literature
Project description:Research in psychoneuroimmunology suggests that immunosuppression associated with perceived stress may contribute to disease progression in persons with HIV infection. While stress management interventions may enhance immune function, few alternative approaches have yet been tested. This randomized clinical trial was conducted to test effects of three 10-week stress management approaches--cognitive-behavioral relaxation training (RLXN), focused tai chi training (TCHI), and spiritual growth groups (SPRT)--in comparison to a wait-listed control group (CTRL) among 252 individuals with HIV infection. Using repeated measures mixed modeling, the authors found that in comparison to the CTRL group, (a) both the RLXN and TCHI groups used less emotion-focused coping, and (b) all treatment groups had augmented lymphocyte proliferative function. Despite modest effects of the interventions on psychosocial functioning, robust findings of improved immune function have important clinical implications, particularly for persons with immune-mediated illnesses.
| S-EPMC4629773 | biostudies-other
Project description:Importance:Colorectal cancer screening rates are suboptimal, particularly among sociodemographically disadvantaged groups. Objective:To examine whether guaranteed money or probabilistic lottery financial incentives conditional on completion of colorectal cancer screening increase screening uptake, particularly among groups with lower screening rates. Design, Setting, and Participants:This parallel, 3-arm randomized clinical trial was conducted from March 13, 2017, through April 12, 2018, at 21 medical centers in an integrated health care system in western Washington. A total of 838 age-eligible patients overdue for colorectal cancer screening who completed a questionnaire that confirmed eligibility and included sociodemographic and psychosocial questions were enrolled. Interventions:Interventions were (1) mail only (n?=?284; up to 3 mailings that included information on the importance of colorectal cancer screening and screening test choices, a fecal immunochemical test [FIT], and a reminder letter if necessary), (2) mail and monetary (n?=?270; mailings plus guaranteed $10 on screening completion), or (3) mail and lottery (n?=?284; mailings plus a 1 in 10 chance of receiving $50 on screening completion). Main Outcomes and Measures:The primary outcome was completion of any colorectal cancer screening within 6 months of randomization. Secondary outcomes were FIT or colonoscopy completion within 6 months of randomization. Intervention effects were compared across sociodemographic subgroups and self-reported psychosocial measures. Results:A total of 838 participants (mean [SD] age, 59.7 [7.2] years; 546 [65.2%] female; 433 [52.2%] white race and 101 [12.1%] Hispanic ethnicity) were included in the study. Completion of any colorectal screening was not significantly higher for the mail and monetary group (207 of 270 [76.7%]) or the mail and lottery group (212 of 284 [74.6%]) than for the mail only group (203 of 284 [71.5%]) (P?=?.11). For FIT completion, interventions had a statistically significant effect (P?=?.04), with a net increase of 7.7% (95% CI, 0.3%-15.1%) in the mail and monetary group and 7.1% (95% CI, -0.2% to 14.3%) in the mail and lottery group compared with the mail only group. For patients with Medicaid insurance, the net increase compared with mail only in FIT completion for the mail and monetary or the mail and lottery group was 37.7% (95% CI, 11.0%-64.3%) (34.2% for the mail and monetary group and 40.4% for the mail and lottery group) compared with a net increase of only 5.6% (95% CI, -0.9% to 12.2%) among those not Medicaid insured (test for interaction P?=?.03). Conclusions and Relevance:Financial incentives increased FIT uptake but not overall colorectal cancer screening. Financial incentives may decrease screening disparities among some sociodemographically disadvantaged groups. Trial Registration:ClinicalTrials.gov identifier: NCT00697047.
| S-EPMC6789432 | biostudies-literature