Economic evaluation of a weight control program with e-mail and telephone counseling among overweight employees: a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Distance lifestyle counseling for weight control is a promising public health intervention in the work setting. Information about the cost-effectiveness of such interventions is lacking, but necessary to make informed implementation decisions. The purpose of this study was to perform an economic evaluation of a six-month program with lifestyle counseling aimed at weight reduction in an overweight working population with a two-year time horizon from a societal perspective.</p> <p>Methods</p> <p>A randomized controlled trial comparing a program with two modes of intervention delivery against self-help. 1386 Employees from seven companies participated (67% male, mean age 43 (SD 8.6) years, mean BMI 29.6 (SD 3.5) kg/m²). All groups received self-directed lifestyle brochures. The two intervention groups additionally received a workbook-based program with phone counseling (phone; n=462) or a web-based program with e-mail counseling (internet; n=464). Body weight was measured at baseline and 24 months after baseline. Quality of life (EuroQol-5D) was assessed at baseline, 6, 12, 18 and 24 months after baseline. Resource use was measured with six-monthly diaries and valued with Dutch standard costs. Missing data were multiply imputed. Uncertainty around differences in costs and incremental cost-effectiveness ratios was estimated by applying non-parametric bootstrapping techniques and graphically plotting the results in cost-effectiveness planes and cost-effectiveness acceptability curves.</p> <p>Results</p> <p>At two years the incremental cost-effectiveness ratio was €1009/kg weight loss in the phone group and €16/kg weight loss in the internet group. The cost-utility analysis resulted in €245,243/quality adjusted life year (QALY) and €1337/QALY, respectively. The results from a complete-case analysis were slightly more favorable. However, there was considerable uncertainty around all outcomes.</p> <p>Conclusions</p> <p>Neither intervention mode was proven to be cost-effective compared to self-help.</p> <p>Trial registration</p> <p>ISRCTN04265725</p

Imatinib in patients with severe COVID-19: a randomised, double-blind, placebo-controlled, clinical trial

Background The major complication of COVID-19 is hypoxaemic respiratory failure from capillary leak and alveolar oedema. Experimental and early clinical data suggest that the tyrosine-kinase inhibitor imatinib reverses pulmonary capillary leak.Methods This randomised, double-blind, placebo-controlled, clinical trial was done at 13 academic and non-academic teaching hospitals in the Netherlands. Hospitalised patients (aged >= 18 years) with COVID-19, as confirmed by an RT-PCR test for SARS-CoV-2, requiring supplemental oxygen to maintain a peripheral oxygen saturation of greater than 94% were eligible. Patients were excluded if they had severe pre-existing pulmonary disease, had pre-existing heart failure, had undergone active treatment of a haematological or non-haematological malignancy in the previous 12 months, had cytopenia, or were receiving concomitant treatment with medication known to strongly interact with imatinib. Patients were randomly assigned (1:1) to receive either oral imatinib, given as a loading dose of 800 mg on day 0 followed by 400 mg daily on days 1-9, or placebo. Randomisation was done with a computer-based clinical data management platform with variable block sizes (containing two, four, or six patients), stratified by study site. The primary outcome was time to discontinuation of mechanical ventilation and supplemental oxygen for more than 48 consecutive hours, while being alive during a 28-day period. Secondary outcomes included safety, mortality at 28 days, and the need for invasive mechanical ventilation. All efficacy and safety analyses were done in all randomised patients who had received at least one dose of study medication (modified intention-to-treat population). This study is registered with the EU Clinical Trials Register (EudraCT 2020-001236-10).Findings Between March 31, 2020, and Jan 4, 2021, 805 patients were screened, of whom 400 were eligible and randomly assigned to the imatinib group (n=204) or the placebo group (n=196). A total of 385 (96%) patients (median age 64 years [IQR 56-73]) received at least one dose of study medication and were included in the modified intention-to-treat population. Time to discontinuation of ventilation and supplemental oxygen for more than 48 h was not significantly different between the two groups (unadjusted hazard ratio [HR] 0.95 [95% CI 0.76-1.20]). At day 28, 15 (8%) of 197 patients had died in the imatinib group compared with 27 (14%) of 188 patients in the placebo group (unadjusted HR 0.51 [0.27-0.95]). After adjusting for baseline imbalances between the two groups (sex, obesity, diabetes, and cardiovascular disease) the HR for mortality was 0.52 (95% CI 0.26-1.05). The HR for mechanical ventilation in the imatinib group compared with the placebo group was 1.07 (0.63-1.80; p=0.81). The median duration of invasive mechanical ventilation was 7 days (IQR 3-13) in the imatinib group compared with 12 days (6-20) in the placebo group (p=0.0080). 91 (46%) of 197 patients in the imatinib group and 82 (44%) of 188 patients in the placebo group had at least one grade 3 or higher adverse event. The safety evaluation revealed no imatinib-associated adverse events.Interpretation The study failed to meet its primary outcome, as imatinib did not reduce the time to discontinuation of ventilation and supplemental oxygen for more than 48 consecutive hours in patients with COVID-19 requiring supplemental oxygen. The observed effects on survival (although attenuated after adjustment for baseline imbalances) and duration of mechanical ventilation suggest that imatinib might confer clinical benefit in hospitalised patients with COVID-19, but further studies are required to validate these findings. Copyright (C) 2021 Elsevier Ltd. All rights reserved.Pathogenesis and treatment of chronic pulmonary disease

Effectiveness of phone and e-mail lifestyle counseling for long term weight control among overweight employees

OBJECTIVES: To determine the effectiveness of a weight-management program with personal counseling by phone or e-mail. METHODS: A randomized controlled trial of a 6-month program comparing two modes of intervention delivery (phone, n = 462; Internet, n = 464) with self-directed materials (control, n = 460), among overweight employees. Change in body weight after 2 years was the main outcome. RESULTS: Among complete cases, weight loss in the Internet group was 1.2 kg (95% confidence interval [CI], -1.9 to -0.4) and in the phone group 0.8 kg (95% CI, -1.5 to 0.03), compared with the control group. Multiple imputation of missing body weight resulted in comparative weight losses of -0.9 kg (95% CI, -2.0 to 0.3) and -0.4 kg (95% CI, -1.4 to 0.7). CONCLUSIONS: Among complete cases, the Internet intervention showed modest long-term weight loss, but among all participants neither program version was more effective than self-help. ©2011The American College of Occupational and Environmental Medicine

Imatinib in patients with severe COVID-19: a randomised, doubleblind, placebo-controlled, clinical trial (vol 9, pg 957, 2021)

Pathogenesis and treatment of chronic pulmonary disease

Imatinib in patients with severe COVID-19: a randomised, doubleblind, placebo-controlled, clinical trial (vol 9, pg 957, 2021)

Pathogenesis and treatment of chronic pulmonary disease

Body mass index and complications following major gastrointestinal surgery: A prospective, international cohort study and meta-analysis

Aim Previous studies reported conflicting evidence on the effects of obesity on outcomes after gastrointestinal surgery. The aims of this study were to explore the relationship of obesity with major postoperative complications in an international cohort and to present a metaanalysis of all available prospective data. Methods This prospective, multicentre study included adults undergoing both elective and emergency gastrointestinal resection, reversal of stoma or formation of stoma. The primary end-point was 30-day major complications (Clavien–Dindo Grades III–V). A systematic search was undertaken for studies assessing the relationship between obesity and major complications after gastrointestinal surgery. Individual patient meta-analysis was used to analyse pooled results. Results This study included 2519 patients across 127 centres, of whom 560 (22.2%) were obese. Unadjusted major complication rates were lower in obese vs normal weight patients (13.0% vs 16.2%, respectively), but this did not reach statistical significance (P = 0.863) on multivariate analysis for patients having surgery for either malignant or benign conditions. Individual patient meta-analysis demonstrated that obese patients undergoing surgery formalignancy were at increased risk of major complications (OR 2.10, 95% CI 1.49–2.96, P < 0.001), whereas obese patients undergoing surgery for benign indications were at decreased risk (OR 0.59, 95% CI 0.46–0.75, P < 0.001) compared to normal weight patients. Conclusions In our international data, obesity was not found to be associated with major complications following gastrointestinal surgery. Meta-analysis of available prospective data made a novel finding of obesity being associated with different outcomes depending on whether patients were undergoing surgery for benign or malignant disease