Within-trial cost and 1-year cost-effectiveness of the DiRECT/Counterweight-Plus weight-management programme to achieve remission of type 2 diabetes.
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ABSTRACT:
SUBMITTER: Xin Y
PROVIDER: S-EPMC6383752 | biostudies-literature | 2019 Mar
REPOSITORIES: biostudies-literature
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Within-trial cost and 1-year cost-effectiveness of the DiRECT/Counterweight-Plus weight-management programme to achieve remission of type 2 diabetes.
Xin Yiqiao Y Davies Andrew A McCombie Louise L Briggs Andrew A Messow C-Martina CM Grieve Eleanor E Leslie Wilma S WS Taylor Roy R Lean Michael E J MEJ
The lancet. Diabetes & endocrinology 20181220 3
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Project description:Aims/hypothesisHigh-throughput metabolomics technologies in a variety of study designs have demonstrated a consistent metabolomic signature of overweight and type 2 diabetes. However, the extent to which these metabolomic patterns can be reversed with weight loss and diabetes remission has been weakly investigated. We aimed to characterise the metabolomic consequences of a weight-loss intervention in individuals with type 2 diabetes.MethodsWe analysed 574 fasted serum samples collected within an existing RCT (the Diabetes Remission Clinical Trial [DiRECT]) (N=298). In the trial, participating primary care practices were randomly assigned (1:1) to provide either a weight management programme (intervention) or best-practice care by guidelines (control) treatment to individuals with type 2 diabetes. Here, metabolomics analysis was performed on samples collected at baseline and 12 months using both untargeted MS and targeted 1H-NMR spectroscopy. Multivariable regression models were fitted to evaluate the effect of the intervention on metabolite levels.ResultsDecreases in branched-chain amino acids, sugars and LDL triglycerides, and increases in sphingolipids, plasmalogens and metabolites related to fatty acid metabolism were associated with the intervention (Holm-corrected p<0.05). In individuals who lost more than 9 kg between baseline and 12 months, those who achieved diabetes remission saw greater reductions in glucose, fructose and mannose, compared with those who did not achieve remission.Conclusions/interpretationWe have characterised the metabolomic effects of an integrated weight management programme previously shown to deliver weight loss and diabetes remission. A large proportion of the metabolome appears to be modifiable. Patterns of change were largely and strikingly opposite to perturbances previously documented with the development of type 2 diabetes.Data availabilityThe data used for analysis are available on a research data repository ( https://researchdata.gla.ac.uk/ ) with access given to researchers subject to appropriate data sharing agreements. Metabolite data preparation, data pre-processing, statistical analyses and figure generation were performed in R Studio v.1.0.143 using R v.4.0.2. The R code for this study has been made publicly available on GitHub at: https://github.com/lauracorbin/metabolomics_of_direct .
| S-EPMC10709482 | biostudies-literature
Project description:IntroductionKilkari is the largest maternal messaging programme of its kind globally. Between its initiation in 2012 in Bihar and its transition to the government in 2019, Kilkari was scaled to 13 states across India and reached over 10 million new and expectant mothers and their families. This study aims to determine the cost-effectiveness of exposure to Kilkari as compared with no exposure across 13 states in India.MethodsThe study was conducted from a programme perspective using an analytic time horizon aligned with national scale-up efforts from December 2014 to April 2019. Economic costs were derived from the financial records of implementing partners. Data on incremental changes in the practice of reproductive maternal newborn and child health (RMNCH) outcomes were drawn from an individually randomised controlled trial in Madhya Pradesh and inputted into the Lives Saved Tool to yield estimates of maternal and child lives saved. One-way and probabilistic sensitivity analyses were carried out to assess uncertainty.ResultsInflation adjusted programme costs were US$8.4 million for the period of December 2014-April 2019, corresponding to an average cost of US$264 298 per year of implementation in each state. An estimated 13 842 lives were saved across 13 states, 96% among children and 4% among mothers. The cost per life saved ranged by year of implementation and with the addition of new states from US$392 ($385-$393) to US$953 ($889-$1092). Key drivers included call costs and incremental changes in coverage for key RMNCH practices.ConclusionKilkari is highly cost-effective using a threshold of India's national gross domestic product of US$1998. Study findings provide important evidence on the cost-effectiveness of a national maternal messaging programme in India.Trial registrationNCT03576157.
| S-EPMC10175950 | biostudies-literature
Project description:Objective:Identifying early predictors of weight loss is key for developing personalized treatment. However, few individual factors have been identified that predict weight loss during intervention, other than early weight loss itself. Methods:Women with overweight or obesity (n = 186, mean ± SD age 50.0 ± 10.6 years, body mass index 34.0 ± 4.2 kg m-2) participated in the Portion-Control Strategies Trial, a 1-year randomized controlled weight-loss trial with three intervention groups. Early changes in eating behaviours and psychological factors were evaluated by questionnaires at baseline and Month 1. The influence of these early changes on the trajectory of weight loss from baseline to Months 3 and 12 was assessed by random coefficients models. Results:Although there were no differences in weight loss between intervention groups at the end of the trial, certain individual factors were shown to predict both early weight loss at Month 3 and longer-term weight loss at Month 12. Across all participants, increases in dietary restraint and healthy lifestyle ratings in the first month predicted more rapid weight loss from baseline to Month 3 (P < 0.05) and also predicted more rapid weight loss and slower regain from baseline to Month 12 (both P < 0.01). Early attendance and changes in disinhibition were not associated with subsequent weight loss. Conclusions:Changes in psychological and behavioural measures, such as restraint, in the first month of weight loss intervention predicted longer-term weight loss in women. Early additional support or tailored treatment could promote long-term success by reinforcing these behaviours.
| S-EPMC5818734 | biostudies-literature
Project description:BackgroundPhase 3 clinical trial results reveal that Qsymia is a clinically effective long-term treatment for obesity, but whether this treatment is cost-effective compared to a diet and lifestyle intervention has yet to be explored.ObjectiveTo quantify the incremental cost-effectiveness of Qsymia (phentermine and topiramate extended-release) for health-related quality of life improvements.Study design and methodsEstimates are based on cost and quality of life outcomes from a 56-week, multicenter, placebo-controlled, phase 3 clinical trial undertaken in 93 health centers in the US. Participants were overweight and obese adults (aged 18-70 years) with a body-mass index of 27-45 kg/m(2) and two or more comorbidities (hypertension, dyslipidemia, diabetes or pre-diabetes or abdominal obesity). The intervention was diet and lifestyle advice plus the recommended dose of Qsymia (phentermine 7.5 mg plus topiramate 46.0 mg) vs. control, which included diet and lifestyle advice plus placebo. The study was from the payer perspective. Costs included the prescription cost, medication cost offsets and physician appointment costs. Effectiveness was measured in terms of quality-adjusted life years gained (QALYs). The main outcome measure was incremental cost per QALY gained of the intervention relative to control.ResultsOur base-case model, in which participants take Qsymia for 1 year with benefits linearly decaying over the subsequent 2 years, generates an incremental cost-effectiveness ratio (ICER) of $48,340 per QALY gained. Using the base-case assumptions, probabilistic sensitivity analyses reveal that the ICER is below $50,000 per QALY in 54 % of simulations. However, results are highly dependent on the extent to which benefits are maintained post medication cessation. If benefits persist for only 1 year post cessation, the ICER increases to $74,480.ConclusionAlthough base-case results suggest that Qsymia is cost-effective, this result hinges on the time on Qsymia and the extent to which benefits are maintained post medication cessation. This should be an area of future research.
| S-EPMC4486409 | biostudies-literature
Project description:ObjectivesThe aim of the study was to evaluate weight loss and maintenance parameters in cats fed a novel weight management food and to assess the owner's perception of the cat's quality of life.MethodsThis study was designed as a prospective, uncontrolled/unmasked clinical trial. One hundred and thirty-two overweight/obese, otherwise healthy, client-owned cats were enrolled. Initial evaluation included physical examination, nutritional assessment, ideal body weight determination and weight-loss feeding guidelines development. Follow-up evaluations (monthly for 6 months) encompassed determination of body weight, body condition score, body fat index, muscle condition score and feeding practices. Quality of life assessment by owners included the cat's level of energy, happiness, appetite, begging behavior, flatulence, stool volume and fecal score.ResultsEighty-three percent of the cats lost weight, with an average ± SEM weight loss of 11.0 ± 1.8% over 6 months and an average ± SE weekly weight loss rate of 0.45 ± 0.02%. The mean ± SEM duration of weight loss was 134.0 ± 4.8 days. Fourteen percent of cats achieved an ideal body weight. Seventy-nine percent of cats ate more calories from novel weight management food than the recommended daily energy requirement for weight loss, and the majority of these cats still lost weight. Body condition score and body fat index decreased over time compared with baseline from weeks 12-24 and from weeks 8-24, respectively. Owners perceived an increase in energy and happiness (>week 12) in the cats that lost weight, without changes in appetite or begging behavior.Conclusions and relevanceThis study confirmed the effectiveness of the novel weight management food in achieving weight loss in overweight/obese client-owned cats. Owners reported significant improvements in their cat's quality of life without negative side effects.
| S-EPMC11112234 | biostudies-literature
Project description:BackgroundSeasonal influenza imposes a significant health and economic burden in South Africa, particularly in populations vulnerable to severe consequences of influenza. This study assesses the cost-effectiveness of South Africa's seasonal influenza vaccination strategy, which involves vaccinating vulnerable populations with trivalent inactivated influenza vaccine (TIV) during routine facility visits. Vulnerable populations included in our analysis are persons aged ≥ 65 years; pregnant women; persons living with HIV/AIDS (PLWHA), persons of any age with underlying medical conditions (UMC) and children aged 6-59 months.MethodWe employed the World Health Organisation's (WHO) Cost Effectiveness Tool for Seasonal Influenza Vaccination (CETSIV), a decision tree model, to evaluate the 2018 seasonal influenza vaccination campaign from a public healthcare provider and societal perspective. CETSIV was populated with existing country-specific demographic, epidemiologic and coverage data to estimate incremental cost-effectiveness ratios (ICERs) by comparing costs and benefits of the influenza vaccination programme to no vaccination.ResultsThe highest number of clinical events (influenza cases, outpatient visits, hospitalisation and deaths) were averted in PLWHA and persons with other UMCs. Using a cost-effectiveness threshold of US$ 3400 per quality-adjusted life year (QALY), our findings suggest that the vaccination programme is cost-effective for all vulnerable populations except for children aged 6-59 months. ICERs ranged from ~US$ 1 750 /QALY in PLWHA to ~US$ 7500/QALY in children. In probabilistic sensitivity analyses, the vaccination programme was cost-effective in pregnant women, PLWHA, persons with UMCs and persons aged ≥65 years in >80% of simulations. These findings were robust to changes in many model inputs but were most sensitive to uncertainty in estimates of influenza-associated illness burden.ConclusionSouth Africa's seasonal influenza vaccination strategy of opportunistically targeting vulnerable populations during routine visits is cost-effective. A budget impact analysis will be useful for supporting future expansions of the programme.
| S-EPMC7804372 | biostudies-literature
Project description:ObjectiveTo assess the overall cost effectiveness of the NHS breast screening programme, based on findings of the Independent UK Panel on Breast Cancer Screening and taking into account the uncertainty of associated estimates of benefits, harms, and costs.DesignA life table model comparing data from two cohorts.SettingUnited Kingdom's health service.Participants and interventions364,500 women aged 50 years-the population of 50 year old women in England and Wales who would be eligible for screening-were followed up for 35 years without screening, compared with a similar cohort who had regular mammographic screening between ages 50 and 70 years and were then followed for another 15 years.Main outcome measuresBetween the cohorts, we compared the number of breast cancer diagnoses, number of deaths from breast cancer, number of deaths from other causes, person years of survival adjusted for health quality, and person years of survival with breast cancer. We also calculated the costs of treating primary and end stage breast cancer, and the costs of screening. Probabilistic sensitivity analysis explored the effect of uncertainty in key input parameters on the model outputs.ResultsUnder the base case scenario (using input parameters derived from the Independent Panel Review), there were 1521 fewer deaths from breast cancer and 2722 overdiagnosed breast cancers. Discounting future costs and benefits at a rate of 3.5% resulted in an additional 6907 person years of survival in the screened cohort, at a cost of 40,946 additional years of survival after a diagnosis of breast cancer. Screening was associated with 2040 additional quality adjusted life years (QALYs) at an additional cost of £42.5m (€49.8m; $64.7m) in total or £20,800 per QALY gained. The gain in person time survival over 35 years was 9.2 days per person and 2.7 quality adjusted days per person screened. Probabilistic sensitivity analysis showed that this incremental cost effectiveness ratio varied widely across a range of plausible scenarios. Screening was cost effective at a threshold of £20,000 per QALY gained in 2260 (45%) scenarios, but in 588 (12%) scenarios, screening was associated with a reduction in QALYs.ConclusionThe NHS breast screening programme is only moderately likely to be cost effective at a standard threshold. However, there is substantial uncertainty in the model parameter estimates, and further primary research will be needed for cost effectiveness studies to provide definitive data to inform policy.
| S-EPMC3649817 | biostudies-literature
Project description:BackgroundDirect oral anticoagulants (DOACs) have demonstrated clinical benefits and better patient adherence over low-molecular-weight heparin (LMWH) in treating patients with cancer-associated venous thrombosis (CAT). We aimed to compare the cost-effectiveness of DOACs against LMWH in patients with CAT from the perspective of the Hong Kong healthcare system.MethodsA Markov state-transition model was performed to estimate the incremental cost-effectiveness ratio (ICER) per quality-adjusted life years (QALYs) for DOACs and LMWH in a hypothetical cohort of 10,000 patients with CAT over a 5-year lifetime horizon. The model was primarily based on the health states of no event, recurrent venous thromboembolism, bleeding, and death. Transition probabilities, relative risks, and utilities were derived from the literature. Resource cost data were obtained from the Hong Kong Hospital Authority. Deterministic and probabilistic sensitivity analyses tested the robustness of the results.ResultsRelative to LMWH, DOACs were associated with increased QALYs (1.52 versus 1.50) at a lower medical cost of USD 2,232 versus 8,224 in five years. The cost of LMWH was the main contributor to the outcome. Out of 10,000 simulated cases, DOACs were dominant in 15.8% and cost-effective in 42.1%, at the willingness-to-pay threshold of USD 148,392 per additional QALY.ConclusionsDOACs were associated with greater QALY improvements and lower overall costs compared to LMWH. Accounting for uncertainty, DOACs were between cost-effective and dominant in 57.9% of cases. DOACs are a cost-effective alternative to LMWH in the management of CAT in Hong Kong.
| S-EPMC11257015 | biostudies-literature
Project description:BackgroundRecently, direct oral anticoagulants (DOACs) have been included in guidelines for the treatment of cancer-associated thrombosis (CAT) to be extended to suitable cancer patients. The purpose of this study was to compare the cost-effectiveness of using DOACs and low molecular weight heparins (LMWHs) for treating CAT from the perspective of the Chinese healthcare system.MethodsA Markov model was constructed to estimate the cost-effectiveness of the two strategies with a 6-month and 5-year time horizon. Input parameters were either sourced from the clinical trial, published literature. The primary outcome of the model was reported as incremental cost-effectiveness ratios (ICERs). Sensitivity analyses were performed to test model uncertainty.ResultsThe 6-month cost of DOACs was $ 654.65 with 0.40 quality adjusted life-years (QALYs) while the 6-month cost of LMWHs was $USD 1719.31 with 0.37 QALYs. Similarly, treatment with DOACs had a lower cost ($USD 657.85 vs. $USD 1716.56) and more health benefits (0.40 QALYs vs. 0.37 QALYs) than treatment with LMWHs in a subgroup of patients with gastrointestinal malignancy. We found treatment with DOACs would result in a large reduction in cost ($USD 1447.22 vs. $USD 3374.70) but a small reduction in QALYs (3.07 QALYs vs. 3.09 QALYs) compared with LMWHs over a 5-year time frame, resulting in an ICER of $USD 112895.50/QALYs. Sensitivity analysis confirmed the robustness of the results.ConclusionAs compared to LMWHs, DOACs can be a cost-saving anticoagulant choice for the treatment of CAT in the general oncology population and gastrointestinal malignancy population.
| S-EPMC8479897 | biostudies-literature
Project description:ObjectiveTo assess the cost-effectiveness of pembrolizumab in combination with chemotherapy compared to chemotherapy alone, based on the results of the NRG-GY018 trial, in patients with advanced or recurrent endometrial cancer (EC), stratified by mismatch repair-deficient (dMMR) and mismatch repair-proficient (pMMR) subgroups.MethodsA Markov model was used to simulate patients receiving either pembrolizumab plus chemotherapy or chemotherapy alone. Lifetime costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER) were calculated using a willingness-to-pay (WTP) threshold of $150,000/QALY. Univariate and probabilistic sensitivity analyses were conducted to assess the robustness of our findings.ResultsThe addition of pembrolizumab to chemotherapy led to an incremental gain of 4.05 QALYs at an additional cost of $167,224, resulting in an ICER of $41,305.09/QALY compared to chemotherapy alone in dMMR EC. Additionally, there were 0.93 additional QALYs at an additional cost of $83,661, which resulted in an ICER of $90,284.80/QALY in pMMR EC. Sensitivity analyses indicated that the cost of pembrolizumab, utility of progressed disease, and utility of progression-free survival had the greatest impact on the results. Probabilistic sensitivity analysis showed that pembrolizumab was considered cost-effective at a 100% probability at a WTP threshold of $150,000 per QALY.ConclusionPembrolizumab, when combined with chemotherapy, was found to be cost-effective compared to chemotherapy alone both for patients with advanced or recurrent dMMR and pMMR EC from the perspective of a payer in the United States.
| S-EPMC11543263 | biostudies-literature