scholarly journals Using Clinical Trial Data to Estimate the Costs of Behavioral Interventions for Potential Adopters: A Guide for Trialists

2020 ◽  
Vol 41 (1) ◽  
pp. 9-20
Author(s):  
Louise B. Russell ◽  
Laurie A. Norton ◽  
David Pagnotti ◽  
Christianne Sevinc ◽  
Sophia Anderson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Financial Incentives ◽  
Behavioral Interventions ◽  
Randomized Clinical Trials ◽  
Financial Incentive ◽  
Trial Data ◽  
Control Group ◽  
Cost Information ◽  
Billing Data ◽  
Pragmatic Clinical Trials

Behavioral interventions involving electronic devices, financial incentives, gamification, and specially trained staff to encourage healthy behaviors are becoming increasingly prevalent and important in health innovation and improvement efforts. Although considerations of cost are key to their wider adoption, cost information is lacking because the resources required cannot be costed using standard administrative billing data. Pragmatic clinical trials that test behavioral interventions are potentially the best and often only source of cost information but rarely incorporate costing studies. This article provides a guide for researchers to help them collect and analyze, during the trial and with little additional effort, the information needed to inform potential adopters of the costs of adopting a behavioral intervention. A key challenge in using trial data is the separation of implementation costs, the costs an adopter would incur, from research costs. Based on experience with 3 randomized clinical trials of behavioral interventions, this article explains how to frame the costing problem, including how to think about costs associated with the control group, and describes methods for collecting data on individual costs: specifications for costing a technology platform that supports the specialized functions required, how to set up a time log to collect data on the time staff spend on implementation, and issues in getting data on device, overhead, and financial incentive costs.

scholarly journals Perceptions of a food benefit program that includes financial incentives for the purchase of fruits and vegetables and restrictions on the purchase of foods high in added sugar

2021 ◽  
pp. 1-24
Author(s):  
Fatima A Fagbenro ◽  
Tessa Lasswell ◽  
Sarah A Rydell ◽  
J Michael Oakes ◽  
Brian Elbel ◽  
...  
Keyword(s):  
Financial Incentives ◽  
Fruits And Vegetables ◽  
Financial Incentive ◽  
Control Group ◽  
Added Sugar ◽  
Program Satisfaction ◽  
Food Purchasing ◽  
Households With Children ◽  
Participant Perspectives

ABSTRACT Objective To report perspectives of participants in a food benefit program that includes FAS restrictions and FAS restrictions paired with F/V incentives. Design Randomized experimental trial in which participant perspectives were an exploratory study outcome. Setting Participants were randomized into one of three SNAP-like food benefit program groups - (1) Restriction: not allowed to buy FAS with benefits; (2) Restriction paired with incentive: not allowed to buy FAS with benefits and 30% financial incentive on eligible F/V purchased using benefits; or (3) Control: Same food purchasing rules as SNAP. Participants were asked questions to assess program satisfaction. Participants Adults in the Minneapolis-St. Paul, MN metropolitan area, eligible for but not currently participating in SNAP who completed baseline and follow-up study measures (n=254). Results Among remaining households in each group, most found the program helpful in buying nutritious foods (88.2%-95.7%) and were satisfied with the program (89.1%-93.0%). Sensitivity analysis results indicate that reported helpfulness and satisfaction with the program may in some instances be lower among the Restriction and the Restrictions paired with Incentive groups in comparison to the control group. Conclusions A food benefit program that includes restriction on purchase of FAS or restriction paired with a financial incentive for F/V purchases may be acceptable to most SNAP-eligible households with children.

scholarly journals Randomised controlled trial of a financial incentive for increasing the number of daily walking steps: study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e026086
Author(s):  
Yasutake Tomata ◽  
Fumiya Tanji ◽  
Dieta Nurrika ◽  
Yingxu Liu ◽  
Saho Abe ◽  
...  
Keyword(s):  
Financial Incentives ◽  
Primary Outcome ◽  
Financial Incentive ◽  
Controlled Trial ◽  
Intervention Group ◽  
Sample Size Calculation ◽  
Community Dwelling ◽  
Control Group ◽  
Modifiable Factors ◽  
Randomised Controlled

IntroductionPhysical activity is one of the major modifiable factors for promotion of public health. Although it has been reported that financial incentives would be effective for promoting health behaviours such as smoking cessation or attendance for cancer screening, few randomised controlled trials (RCTs) have examined the effect of financial incentives for increasing the number of daily steps among individuals in a community setting. The aim of this study is to investigate the effects of financial incentives for increasing the number of daily steps among community-dwelling adults in Japan.Methods and analysisThis study will be a two-arm, parallel-group RCT. We will recruit community-dwelling adults who are physically inactive in a suburban area (Nakayama) of Sendai city, Japan, using leaflets and posters. Participants that meet the inclusion criteria will be randomly allocated to an intervention group or a waitlist control group. The intervention group will be offered a financial incentive (a chance to get shopping points) if participants increase their daily steps from their baseline. The primary outcome will be the average increase in the number of daily steps (at 4–6 weeks and 7–9 weeks) relative to the average number of daily steps at the baseline (1–3 weeks). For the sample size calculation, we assumed that the difference of primary outcome would be 1302 steps.Ethics and disseminationThis study has been ethically approved by the research ethics committee of Tohoku University Graduate School of Medicine, Japan (No. 2018-1-171). The results will be submitted and published in a peer-reviewed scientific journal.Trial registration numberUMIN000033276; Pre-results.

scholarly journals EFFICACY OF SPIRULINA FOR ALLERGIC RHINITIS

2021 ◽  
Author(s):  
Iury Gomes Batista ◽  
Osmar Cleyton Person ◽  
Fernando Veiga Angelico Junior ◽  
Priscila Bogar
Keyword(s):  
Clinical Trials ◽  
Allergic Rhinitis ◽  
Randomized Clinical Trials ◽  
Nasal Congestion ◽  
Control Group ◽  
Cochrane Central Register ◽  
Level Of Evidence ◽  
Runny Nose ◽  
Trial Quality ◽  
Central Register

Introduction: Allergic rhinitis is a condition of high prevalence in the population and widely studied, with several treatments being consecrated for its control. Spirulina is a dietary supplement that modulates immune function, and has been shown to modulate the inflammatory response of allergic rhinitis. Purpose: To evaluate spirulina in the treatment and control of allergic rhinitis. Material and Methods: This is a systematic review of randomized clinical trials. Searches were performed for randomized clinical trials relating spirulina to allergic rhinitis in five electronic databases: Cochrane - Central Register of Controlled Trials - CENTRAL (2021), PUBMED (1966-2021), EMBASE (1974-2021), LILACS (1982-2021) AND SCOPUS (2021). Two investigators independently extracted data and assessed trial quality. Results: Two clinical trials involving a total of 215 patients were included. Both studies assessed the efficacy of spirulina in improving allergic rhinitis as the primary outcome. The first study described a significant reduction in runny nose, nasal congestion and itching over time of medication use (p 0.001) and in the second study the prevalence of rhinorrhea (P = 0.021), nasal congestion or obstruction (P = 0.039) and decreased smell (P = 0.030) were significantly less in the experimental group than in the control group. Conclusions: The included studies were in favor of the use of spirrulina. However, the level of evidence is very low and limited. We should have caution due to the small number of clinical trials and participants in these studies. It is recommended to carry out new RCTs following the CONSORT standardization.

Design of Control-Group Conditions in Clinical Trials of Behavioral Interventions

2007 ◽  
Vol 39 (3) ◽  
pp. 214-221 ◽  
Author(s):  
Ruth Lindquist ◽  
Jean F. Wyman ◽  
Kristine M.C. Talley ◽  
Mary J. Findorff ◽  
Cynthia R. Gross
Keyword(s):  
Clinical Trials ◽  
Behavioral Interventions ◽  
Control Group

scholarly journals The Application of Beta-Tricalcium Phosphate in Implant Dentistry: A Systematic Evaluation of Clinical Studies

Materials ◽  
2022 ◽  
Vol 15 (2) ◽  
pp. 655
Author(s):  
Elisabet Roca-Millan ◽  
Enric Jané-Salas ◽  
Antonio Marí-Roig ◽  
Álvaro Jiménez-Guerra ◽  
Iván Ortiz-García ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Survival Rate ◽  
Tricalcium Phosphate ◽  
Randomized Clinical Trials ◽  
Systematic Evaluation ◽  
Control Group ◽  
Cochrane Central Register ◽  
Graft Material ◽  
Synthetic Graft ◽  
Implant Dentistry

The demand for synthetic graft materials in implant dentistry is rising. This systematic review aims to evaluate the survival rate of dental implants placed simultaneously with bone regeneration procedures using the material β-tricalcium phosphate, one of the most promising synthetic graft materials. The electronic search was conducted in PubMed, Scielo, and the Cochrane Central Register of Controlled Trials. There were five randomized clinical trials, one of which was a non-randomized controlled clinical trial and four of which were observational studies without a control group included. Implant survival rate and other clinical, radiographic, and histological parameters did not differ from those of implants placed simultaneously with another type of graft material, or placed in blood clots or natural alveolar ridges. Based on the available literature, β-tricalcium phosphate seems to be a promising graft material in implant dentistry. Nevertheless, more randomized clinical trials, with long follow-up periods, preoperative and postoperative CBCT, and histological analysis, are necessary to assess its long-term behavior.

The yin and yang of pragmatic clinical trials of behavioral interventions for chronic pain

Pain ◽  
2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Francis J. Keefe ◽  
Mark P. Jensen ◽  
Amanda C de C Williams ◽  
Steven Z. George
Keyword(s):  
Chronic Pain ◽  
Clinical Trials ◽  
Behavioral Interventions ◽  
Pragmatic Clinical Trials ◽  
Yin And Yang

Metabolic deterioration of the sedentary control group in clinical trials

2011 ◽  
Vol 111 (4) ◽  
pp. 1211-1217 ◽  
Author(s):  
Mahesh J. Patel ◽  
Cris A. Slentz ◽  
William E. Kraus
Keyword(s):  
Physical Activity ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Health Benefits ◽  
Moderate Intensity ◽  
Control Group ◽  
Genetic Profile ◽  
Sedentary Control ◽  
Physical Activity Recommendations ◽  
Activity Recommendations

Randomized clinical trials of exercise training regimens in sedentary individuals have provided a mechanistic understanding of the long-term health benefits and consequences of physical activity and inactivity. The sedentary control periods from these trials have provided evidence of the progressive metabolic deterioration that results from as little as 4–6 mo of continuing a physically inactive lifestyle. These clinical trials have also demonstrated that only a modest amount of physical activity is required to prevent this metabolic deterioration, and this amount of physical activity is consistent with current physical activity recommendations (150 min/wk of moderate intensity physical activity). These recommendations have been issued to the general population for a vast array of health benefits. While greater adherence to these recommendations should result in substantial improvements in the health of the population, these recommendations still remain inadequate for many individuals. An individual's physical activity requirements are influenced by such factors as an individual's diet, nonexercise physical activity patterns, genetic profile, and medications. Improving the understanding of how these factors influence an individual's physical activity requirements will help advance the field and help move the field toward the development of more personalized physical activity recommendations.

Randomized Clinical Trials of Self-Management With Asian/Pacific Islanders

2011 ◽  
Vol 20 (4) ◽  
pp. 366-403 ◽  
Author(s):  
Jillian Inouye ◽  
Nafanua Braginsky ◽  
Merle Kataoka-Yahiro
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Chronic Conditions ◽  
Behavioral Interventions ◽  
Randomized Clinical Trials ◽  
Descriptive Analysis ◽  
Management Strategies ◽  
Pacific Islanders ◽  
Self Management

Little has been reported in the literature about self-management strategies of chronic conditions in Asian and Pacific Islanders (APIs). The purpose of this systematic review was to investigate randomized clinical trials (RCTs) of self-management strategies of chronic conditions in APIs. Twenty-one studies were included in the final review, published between 1997 and 2010. Initially, the Jadad Scoring of Quality of Reports of Randomized Clinical Trials (JSQRRC) was used to determine the quality of RCT studies. The researchers then did a systematic review of each of the RCTs based on the JSQRRC criteria. JSQRRC scores ranged from 8 to 12, M = 9.6. Descriptive analysis indicated cognitive behavioral interventions as an effective treatment methodology for APIs. The results underscore the importance of clarifying the methodological components and reporting of RCTs. Interventions appropriate for APIs using disaggregated ethnic groups are essential to determine specific cultural responses to treatments and outcomes.

Comparison of Monetary Reinforcers and Goal Setting as Learning Incentives

1985 ◽  
Vol 56 (1) ◽  
pp. 223-235 ◽  
Author(s):  
Vandra L. Huber
Keyword(s):  
Goal Setting ◽  
Financial Incentives ◽  
Training Programs ◽  
Financial Incentive ◽  
Control Group ◽  
Laboratory Setting ◽  
Performance Goal ◽  
Piece Rate ◽  
Significant Performance ◽  
Linear Trends

This 3 × 3 study (with one cell missing) examined the effectiveness of goal setting (participative, assigned, and no goals) and financial incentives (noncontingent, piece rate, and goal contingent) as techniques to stimulate learning 88 inexperienced trainees performed a 10-hr., 5-day proofreading proficiency task in a laboratory setting. The linear trends for all groups except the control group in which noncontingent ($30 for completing the training period) pay was offered were significant. Planned comparisons indicated that learning was greatest when a performance goal was assigned and a financial incentive offered for demonstrating that level of performance. The offer of piece-rate reinforcement also stimulated faster learning than the offer of noncontingent pay. Setting goals, regardless of the method, did not result in significant performance increases beyond that achieved by offering a $30 incentive for merely completing the training. Finally, financial incentives affected goal choice. Implications for training programs were discussed.

scholarly journals Effect of traditional resistance training on blood pressure in normotensive elderly persons: a systematic review of randomized controlled trials and meta-analyses

2017 ◽  
Vol 20 (4) ◽  
pp. 571-581 ◽  
Author(s):  
Durcelina Schiavoni ◽  
Ligia Maxwell Pereira ◽  
Hugo Maxwell Pereira ◽  
Edilson Serpeloni Cyrino ◽  
Jefferson Rosa Cardoso
Keyword(s):  
Systematic Review ◽  
Blood Pressure ◽  
Clinical Trials ◽  
Resistance Training ◽  
Randomized Clinical Trials ◽  
Random Effect Model ◽  
Control Group ◽  
Elderly Persons ◽  
Traditional Resistance Training ◽  
Meta Analyses

Abstract The objective of the present study was to determine the effectiveness of the regular practice of traditional resistance training (RT) on systolic (SBP) and diastolic blood pressure (DBP) in normotensive elderly persons. A systematic review of randomized clinical trials and meta-analyses was performed. Searches were performed without language restrictions in different databases. Randomized clinical trials published from 1966 to 2010 that assessed the effects of traditional RT on resting blood pressure (BP) and/or for the treatment of high BP were included. Only studies that assessed the effects of traditional RT on elderly adults, regardless of the number of exercises, with the presence of a control group and comparisons between groups, were included. Twenty-nine studies were found, but only six met the inclusion criteria. The mean difference was used for meta-analysis, using a 95% confidence interval and a random effect model. Traditional RT induced a significant decrease in SBP (-6.63 mmHg; p=0.02) but not in DBP (-3.34 mmHg; p=0.11). These results suggest that traditional RT may be a non-pharmacological strategy for the control of BP in the elderly.

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