Cost consequence analysis of transcutaneous tibial nerve stimulation (TTNS) for urinary incontinence in care home residents alongside a randomised controlled trial

Background: Urinary incontinence (UI) is prevalent in more than half of residents of nursing and residential care homes and can have a detrimental impact on dignity and quality of life. Care homes predominantly use absorbent pads to contain UI rather than actively treat the condition. Transcutaneous tibial nerve stimulation (TTNS) is a non-invasive, safe, low-cost intervention with demonstrated effectiveness for reducing UI in adults. We examined the costs and consequences of delivering TTNS to care home residents in comparison to sham (inactive) electrical stimulation.Methods: A cost consequence analysis approach was used to assemble and present the resource use and outcome data for the ELECTRIC trial which randomised 406 residents with UI from 37 care homes in the United Kingdom to receive 12 sessions of 30 minutes of either TTNS or sham (inactive) TTNS. TTNS was administered by care home staff over 6 weeks. Health state utility was measured using DEMQOL-U and DEMQOL-PROXY-U at baseline, 6 weeks and 18 weeks follow-up. Staff completed a resource use questionnaire at baseline, 6 weeks and 18 weeks follow-up, which also assessed use of absorbent pads. Results: HRQoL did not change significantly in either randomised group. Delivery of TTNS was estimated to cost £81.20 per participant, plus training and support costs of £121.03 per staff member. 85% of participants needed toilet assistance as routine, on average requiring one or two staff members to be involved 4 or 5 times in each 24 hours. Daily use of mobility aids and other assistive devices to use the toilet were reported. The value of staff time to assist residents to use the toilet (assuming an average of 5 minutes per resident per visit) was estimated as £19.17 (SD 13.22) for TTNS and £17.30 (SD 13.33) for sham (per resident in a 24-hour period).Conclusions: Use of TTNS to treat UI in care home residents did not lead to changes in resource use, particularly any reduction in the use of absorbent pads and no cost benefits for TTNS were shown. Managing continence in care homes is labour intensive, requiring both high levels of staff time and use of equipment aids

Text Messages With Financial Incentives for Men With Obesity : A Randomized Clinical Trial

Peer reviewe

Stroke in Patients With Acute Coronary Syndromes: Incidence and Outcomes in the Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) Trial

BACKGROUND: The incidence of stroke in patients with acute coronary syndromes has not been clearly defined because few trials in this patient population have been large enough to provide stable estimates of stroke rates. METHODS AND RESULTS: We studied the 10 948 patients with acute coronary syndromes without persistent ST-segment elevation who were randomly assigned to placebo or the platelet glycoprotein IIb/IIIa receptor inhibitor eptifibatide in the Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) trial to determine stroke rates, stroke types, clinical outcomes in patients with stroke, and independent baseline clinical predictors for nonhemorrhagic stroke. Stroke occurred in 79 (0.7%) patients, with 66 (0.6%) nonhemorrhagic, 6 intracranial hemorrhages, 3 cerebral infarctions with hemorrhagic conversion, and 4 of uncertain cause. There were no differences in stroke rates between patients who received placebo and those assigned high-dose eptifibatide (odds ratios and 95% confidence intervals 0.82 [0.59, 1.14] and 0.70 [0.49, 0.99], respectively). Of the 79 patients with stroke, 17 (22%) died within 30 days, and another 26 (32%) were disabled by hospital discharge or 30 days, whichever came first. Higher heart rate was the most important baseline clinical predictor of nonhemorrhagic stroke, followed by older age, prior anterior myocardial infarction, prior stroke or transient ischemic attack, and diabetes mellitus. These factors were used to develop a simple scoring nomogram that can predict the risk of nonhemorrhagic stroke. CONCLUSIONS: Stro

Text messages with financial incentives for men with obesity. A randomized clinical trial

Importance: Effective weight loss interventions are needed for men with obesity. Objective : To determine whether an intervention that combined text messaging with financial incentives attained significant weight loss at the 12-month follow-up compared with the control group and whether an intervention of text messaging alone attained significant weight loss at the 12-month follow-up compared with the control group. Design, Setting, and Participants: An assessor-blinded randomized clinical trial conducted in Belfast, Bristol, and Glasgow areas in the UK. A total of 585 men with body mass index (BMI) of 30 or more were enrolled between July 2021 and May 2022. Final follow-up occurred June 2023. Interventions: Participants were randomly assigned to 12 months of behavioral focused text messages combined with financial incentives (n = 196), 12 months of behavioral focused text messages alone (n= 194), or a waiting list (control group; n= 195). The financial incentive consisted of a monetary reward that was lost if weight loss targets were not met. All participants received weight management information and a pedometer at baseline. Main Outcomes and Measures: The 2 primary comparisons were the 12-month comparison of within-participant weight change between the text messaging with financial incentive group and the control group and the comparison between the text messaging alone group and the control group (minimum clinically important difference, 3%). The P value defined for statistical significance was P < .025 for each comparison. Results: Of the 585 men (mean [SD] age, 50.7 [13.3] years; mean weight, 118.5 [19.9] kg; mean BMI, 37.7 [5.7]; 525 [90%] White), 227 (39%) lived in postal code areas with lower socioeconomic status, and 426 (73%) completed the 12-month follow-up. At the 12-month follow-up, compared with the control group, the mean percent weight change was significantly greater in the text messaging with financial incentive group (mean difference, −3.2%; 97.5% CI, −4.6% to −1.9%; P < .001) but was not significantly greater in the text messaging alone group (mean difference, −1.4%; 97.5% CI, −2.9% to 0.0, P = .05). The mean (SD) weight changes were −5.7 (7.4) kg for the text messaging with financial incentives group, −3.0 (7.5) kg for the text messaging alone group, and −1.5 (6.6) kg for the control group. The 12-month mean (SD) percentage weight changes from baseline were −4.8% (6.1%) for the text messaging with financial incentives group, −2.7% (6.3%) for text messaging alone group, and −1.3% (5.5%) for the control group. Of 366 adverse events reported, the most common were infections (83 [23%]). Of the 23 serious adverse events (6.3%), 12 (52%) occurred in the text messaging with financial incentives group, 5 (22%) in the texts messaging alone group, and 6 (26%) in the control group. None were considered related to participating in a trial group. Conclusion and Relevance: Among men with obesity, an intervention with text messaging with financial incentive significantly improved weight loss compared with a control group, whereas text messaging alone was not significantly better than the control condition. These findings support text messaging combined with financial incentives to attain weight loss in men with obesityOutput Status: Forthcoming/Available Onlin

Study protocol of European Fans in Training (EuroFIT):a four-country randomised controlled trial of a lifestyle program for men delivered in elite football clubs

Background: Lifestyle interventions targeting physical activity, sedentary time and dietary behaviours have the potential to initiate and support behavioural change and result in public health gain. Although men have often been reluctant to engage in such lifestyle programs, many are at high risk of several chronic conditions. We have developed an evidence and theory-based, gender sensitised, health and lifestyle program (European Fans in Training (EuroFIT)), which is designed to attract men through the loyalty they feel to the football club they support. This paper describes the study protocol to evaluate the effectiveness and cost-effectiveness of the EuroFIT program in supporting men to improve their level of physical activity and reduce sedentary behaviour over 12 months. Methods: The EuroFIT study is a pragmatic, two-arm, randomised controlled trial conducted in 15 football clubs in the Netherlands, Norway, Portugal and the UK (England). One-thousand men, aged 30 to 65 years, with a self-reported Body Mass Index (BMI) ≥27 kg/m2 will be recruited and individually randomised. The primary outcomes are objectively-assessed changes in total physical activity (steps per day) and total sedentary time (minutes per day) at 12 months after baseline assessment. Secondary outcomes are weight, BMI, waist circumference, resting systolic and diastolic blood pressure, cardio-metabolic blood biomarkers, food intake, self-reported physical activity and sedentary time, wellbeing, self-esteem, vitality and quality of life. Cost-effectiveness will be assessed and a process evaluation conducted. The EuroFIT program will be delivered over 12 weekly, 90-minute sessions that combine classroom discussion with graded physical activity in the setting of the football club. Classroom sessions provide participants with a toolbox of behaviour change techniques to initiate and sustain long-term lifestyle changes. The coaches will receive two days of training to enable them to create a positive social environment that supports men in engaging in sustained behaviour change. Discussion: The EuroFIT trial will provide evidence on the effectiveness and cost-effectiveness of the EuroFIT program delivered by football clubs to their male fans, and will offer insight into factors associated with success in making sustained changes to physical activity, sedentary behaviour, and secondary outcomes, such as diet.Trial registration: ISRCTN: 81935608. Registered 16 June 2015.<br/

Text messages with financial incentives for men with obesity. A randomized clinical trial

Importance: Effective weight loss interventions are needed for men with obesity. Objective : To determine whether an intervention that combined text messaging with financial incentives attained significant weight loss at the 12-month follow-up compared with the control group and whether an intervention of text messaging alone attained significant weight loss at the 12-month follow-up compared with the control group. Design, Setting, and Participants: An assessor-blinded randomized clinical trial conducted in Belfast, Bristol, and Glasgow areas in the UK. A total of 585 men with body mass index (BMI) of 30 or more were enrolled between July 2021 and May 2022. Final follow-up occurred June 2023. Interventions: Participants were randomly assigned to 12 months of behavioral focused text messages combined with financial incentives (n = 196), 12 months of behavioral focused text messages alone (n= 194), or a waiting list (control group; n= 195). The financial incentive consisted of a monetary reward that was lost if weight loss targets were not met. All participants received weight management information and a pedometer at baseline. Main Outcomes and Measures: The 2 primary comparisons were the 12-month comparison of within-participant weight change between the text messaging with financial incentive group and the control group and the comparison between the text messaging alone group and the control group (minimum clinically important difference, 3%). The P value defined for statistical significance was P < .025 for each comparison. Results: Of the 585 men (mean [SD] age, 50.7 [13.3] years; mean weight, 118.5 [19.9] kg; mean BMI, 37.7 [5.7]; 525 [90%] White), 227 (39%) lived in postal code areas with lower socioeconomic status, and 426 (73%) completed the 12-month follow-up. At the 12-month follow-up, compared with the control group, the mean percent weight change was significantly greater in the text messaging with financial incentive group (mean difference, −3.2%; 97.5% CI, −4.6% to −1.9%; P < .001) but was not significantly greater in the text messaging alone group (mean difference, −1.4%; 97.5% CI, −2.9% to 0.0, P = .05). The mean (SD) weight changes were −5.7 (7.4) kg for the text messaging with financial incentives group, −3.0 (7.5) kg for the text messaging alone group, and −1.5 (6.6) kg for the control group. The 12-month mean (SD) percentage weight changes from baseline were −4.8% (6.1%) for the text messaging with financial incentives group, −2.7% (6.3%) for text messaging alone group, and −1.3% (5.5%) for the control group. Of 366 adverse events reported, the most common were infections (83 [23%]). Of the 23 serious adverse events (6.3%), 12 (52%) occurred in the text messaging with financial incentives group, 5 (22%) in the texts messaging alone group, and 6 (26%) in the control group. None were considered related to participating in a trial group. Conclusion and Relevance: Among men with obesity, an intervention with text messaging with financial incentive significantly improved weight loss compared with a control group, whereas text messaging alone was not significantly better than the control condition. These findings support text messaging combined with financial incentives to attain weight loss in men with obesit

Correction:The effect of a programme to improve men's sedentary time and physical activity: The European Fans in Training (EuroFIT) randomised controlled trial (PLoS medicine (2019) 16 2 (e1002736))

[This corrects the article DOI: 10.1371/journal.pmed.1002736.].status: publishe