scholarly journals Nicotine preloading for smoking cessation: the Preloading RCT

2018 ◽  
Vol 22 (41) ◽  
pp. 1-84 ◽  
Author(s):  
Paul Aveyard ◽  
Nicola Lindson ◽  
Sarah Tearne ◽  
Rachel Adams ◽  
Khaled Ahmed ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Health Service ◽  
Primary Outcome ◽  
Nicotine Patch ◽  
Intervention Group ◽  
Control Group ◽  
Open Label ◽  
Percentage Points ◽  
Health Service Costs

BackgroundNicotine preloading means using nicotine replacement therapy prior to a quit date while smoking normally. The aim is to reduce the drive to smoke, thereby reducing cravings for smoking after quit day, which are the main cause of early relapse. A prior systematic review showed inconclusive and heterogeneous evidence that preloading was effective and little evidence of the mechanism of action, with no cost-effectiveness data.ObjectivesTo assess (1) the effectiveness, safety and tolerability of nicotine preloading in a routine NHS setting relative to usual care, (2) the mechanisms of the action of preloading and (3) the cost-effectiveness of preloading.DesignOpen-label randomised controlled trial with examination of mediation and a cost-effectiveness analysis.SettingNHS smoking cessation clinics.ParticipantsPeople seeking help to stop smoking.InterventionsNicotine preloading comprised wearing a 21 mg/24 hour nicotine patch for 4 weeks prior to quit date. In addition, minimal behavioural support was provided to explain the intervention rationale and to support adherence. In the comparator group, participants received equivalent behavioural support. Randomisation was stratified by centre and concealed from investigators.Main outcome measuresThe primary outcome was 6-month prolonged abstinence assessed using the Russell Standard. The secondary outcomes were 4-week and 12-month abstinence. Adverse events (AEs) were assessed from baseline to 1 week after quit day. In a planned analysis, we adjusted for the use of varenicline (Champix®; Pfizer Inc., New York, NY, USA) as post-cessation medication. Cost-effectiveness analysis took a health-service perspective. The within-trial analysis assessed health-service costs during the 13 months of trial enrolment relative to the previous 6 months comparing trial arms. The base case was based on multiple imputation for missing cost data. We modelled long-term health outcomes of smoking-related diseases using the European-study on Quantifying Utility of Investment in Protection from Tobacco (EQUIPT) model.ResultsIn total, 1792 people were eligible and were enrolled in the study, with 893 randomised to the control group and 899 randomised to the intervention group. In the intervention group, 49 (5.5%) people discontinued preloading prematurely and most others used it daily. The primary outcome, biochemically validated 6-month abstinence, was achieved by 157 (17.5%) people in the intervention group and 129 (14.4%) people in the control group, a difference of 3.02 percentage points [95% confidence interval (CI) –0.37 to 6.41 percentage points; odds ratio (OR) 1.25, 95% CI 0.97 to 1.62;p = 0.081]. Adjusted for use of post-quit day varenicline, the OR was 1.34 (95% CI 1.03 to 1.73;p = 0.028). Secondary abstinence outcomes were similar. The OR for the occurrence of serious AEs was 1.12 (95% CI 0.42 to 3.03). Moderate-severity nausea occurred in an additional 4% of the preloading group compared with the control group. There was evidence that reduced urges to smoke and reduced smoke inhalation mediated the effect of preloading on abstinence. The incremental cost-effectiveness ratio at the 6-month follow-up for preloading relative to control was £710 (95% CI –£13,674 to £23,205), but preloading was dominant at 12 months and in the long term, with an 80% probability that it is cost saving.LimitationsThe open-label design could partially account for the mediation results. Outcome assessment could not be blinded but was biochemically verified.ConclusionsUse of nicotine-patch preloading for 4 weeks prior to attempting to stop smoking can increase the proportion of people who stop successfully, but its benefit is undermined because it reduces the use of varenicline after preloading. If this latter effect could be overcome, then nicotine preloading appears to improve health and reduce health-service costs in the long term. Future work should determine how to ensure that people using nicotine preloading opt to use varenicline as cessation medication.Trial registrationCurrent Controlled Trials ISRCTN33031001.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 41. See the NIHR Journals Library website for further project information.

scholarly journals Cost-effectiveness of a stepwise cardiometabolic disease prevention program: results of a randomized controlled trial in primary care

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Daphne M. Stol ◽  
Eelco A. B. Over ◽  
Ilse F. Badenbroek ◽  
Monika Hollander ◽  
Mark M. J. Nielen ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Primary Care ◽  
Cost Effectiveness ◽  
Prevention Program ◽  
Healthcare Costs ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group

Abstract Background Cardiometabolic diseases (CMD) are the major cause of death worldwide and are associated with a lower quality of life and high healthcare costs. To prevent a further rise in CMD and related healthcare costs, early detection and adequate management of individuals at risk could be an effective preventive strategy. The objective of this study was to determine long-term cost-effectiveness of stepwise CMD risk assessment followed by individualized treatment if indicated compared to care as usual. A computer-based simulation model was used to project long-term health benefits and cost-effectiveness, assuming the prevention program was implemented in Dutch primary care. Methods A randomized controlled trial in a primary care setting in which 1934 participants aged 45–70 years without recorded CMD or CMD risk factors participated. The intervention group was invited for stepwise CMD risk assessment through a risk score (step 1), additional risk assessment at the practice in case of increased risk (step 2) and individualized follow-up treatment if indicated (step 3). The control group was not invited for risk assessment, but completed a health questionnaire. Results of the effectiveness analysis on systolic blood pressure (− 2.26 mmHg; 95% CI − 4.01: − 0.51) and total cholesterol (− 0.15 mmol/l; 95% CI − 0.23: − 0.07) were used in this analysis. Outcome measures were the costs and benefits after 1-year follow-up and long-term (60 years) cost-effectiveness of stepwise CMD risk assessment compared to no assessment. A computer-based simulation model was used that included data on disability weights associated with age and disease outcomes related to CMD. Analyses were performed taking a healthcare perspective. Results After 1 year, the average costs in the intervention group were 260 Euro higher than in the control group and differences were mainly driven by healthcare costs. No meaningful change was found in EQ 5D-based quality of life between the intervention and control groups after 1-year follow-up (− 0.0154; 95% CI − 0.029: 0.004). After 60 years, cumulative costs of the intervention were 41.4 million Euro and 135 quality-adjusted life years (QALY) were gained. Despite improvements in blood pressure and cholesterol, the intervention was not cost-effective (ICER of 306,000 Euro/QALY after 60 years). Scenario analyses did not allow for a change in conclusions with regard to cost-effectiveness of the intervention. Conclusions Implementation of this primary care-based CMD prevention program is not cost-effective in the long term. Implementation of this program in primary care cannot be recommended. Trial registration Dutch Trial Register NTR4277, registered on 26 November 2013

scholarly journals Adding emollient bath additives to standard eczema management for children with eczema: the BATHE RCT

2018 ◽  
Vol 22 (57) ◽  
pp. 1-116 ◽  
Author(s):  
Miriam Santer ◽  
Kate Rumsby ◽  
Matthew J Ridd ◽  
Nick A Francis ◽  
Beth Stuart ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Primary Outcome ◽  
Intervention Group ◽  
Additive Group ◽  
Health Technology ◽  
Control Group ◽  
Open Label ◽  
Secondary Outcomes ◽  
Bath Additives

BackgroundChildhood eczema is very common. Treatment often includes emollient bath additives, despite there being little evidence of their effectiveness.ObjectivesTo determine the clinical effectiveness and cost-effectiveness of emollient bath additives in the management of childhood eczema.DesignPragmatic, randomised, open-label, multicentre superiority trial with two parallel groups.SettingNinety-six general practices in Wales, the west of England and southern England. Invitation by personal letter or opportunistically.ParticipantsChildren aged between 12 months and 12 years fulfilling the UK Diagnostic Criteria for Atopic Eczema. Children with inactive or very mild eczema (a score of ≤ 5 on the Nottingham Eczema Severity Scale) were excluded, as were children who bathed less than once per week or whose parents/carers were not prepared to accept randomisation.InterventionsThe intervention group were prescribed bath additives by their usual clinical team and were asked to use them regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued standard eczema management, including regular leave-on emollients and topical corticosteroids (TCSs) when required.Main outcome measuresThe primary outcome was eczema control measured by Patient Oriented Eczema Measure [POEM, 0 (clear) to 28 (severe)] weekly for 16 weeks. The secondary outcomes were eczema severity over 1 year (4-weekly POEM), number of eczema exacerbations, disease-specific quality of life (QoL) (Dermatitis Family Impact Questionnaire), generic QoL (Child Health Utility-9 Dimensions) and type and quantity of topical steroid/calcineurin inhibitors prescribed. Children were randomised (1 : 1) using online software to either bath additives plus standard eczema care or standard eczema care alone, stratified by recruiting centre, and there was open-label blinding.ResultsFrom December 2014 to May 2016, 482 children were randomised: 51% were female, 84% were white and the mean age was 5 years (n = 264 in the intervention group,n = 218 in the control group). Reported adherence to randomised treatment allocation was > 92% in both groups, with 76.7% of participants completing at least 12 (80%) of the first 16 weekly questionnaires for the primary outcome. Baseline POEM score was 9.5 [standard deviation (SD) 5.7] in the bath additives group and 10.1 (SD 5.8) in the no bath additives group. Average POEM score over the first 16 weeks was 7.5 (SD 6.0) in the bath additives group and 8.4 (SD 6.0) in the no bath additives group, with no statistically significant difference between the groups. After controlling for baseline severity and confounders (ethnicity, TCS use, soap substitute use) and allowing for clustering of participants within centres and responses within participants over time, POEM scores in the no bath additive group were 0.41 points higher than in the bath additive group (95% confidence interval –0.27 to 1.10), which is well below the published minimal clinically important difference of 3 points. There was no difference between groups in secondary outcomes or in adverse effects such as redness, stinging or slipping.LimitationsSimple randomisation resulted in an imbalance in baseline group size, although baseline characteristics were well balanced between groups.ConclusionThis trial found no evidence of clinical benefit of including emollient bath additives in the standard management of childhood eczema.Future workFurther research is required on optimal regimens of leave-on emollients and the use of emollients as soap substitutes.Trial registrationCurrent Controlled Trials ISRCTN84102309.FundingThis project was funded by the NIHR Health Technology Assessment Programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 57. See the NIHR Journals Library website for further project information.

scholarly journals Evaluating the effects of an exercise program (Staying UpRight) for older adults in long-term care on rates of falls: study protocol for a randomised controlled trial

2019 ◽  
Author(s):  
Lynne Taylor ◽  
John Parsons ◽  
Denise Taylor ◽  
Elizabeth Binns ◽  
Sue Lord ◽  
...  
Keyword(s):  
Older Adults ◽  
Cost Effectiveness ◽  
Long Term Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Program ◽  
Community Dwelling ◽  
Control Group ◽  
Term Care

Abstract Background Falls are two to four times more frequent amongst long-term care (LTC) than community-dwelling older adults and have deleterious consequences. It is hypothesized that a progressive exercise program targeting balance and strength will reduce falls rates when compared to a seated exercise program and do so cost effectively. Methods/Design This is a single blind, parallel-group, randomized controlled trial with blinded assessment of outcome and intention-to-treat analysis. LTC residents (age ≥65 years) will be recruited from LTC facilities in New Zealand. Participants (n= 528 total; with a 1:1 allocation ratio) will be randomly assigned to either a novel exercise program (Staying UpRight), comprising strength and balance exercises designed specifically for LTC and acceptable to people with dementia, (intervention group) or a seated exercise program (control group). The intervention and control group classes will be delivered for 1 hour twice weekly over 1 year. The primary outcome is rate of falls (per 1000 person years) within the intervention period. Secondary outcomes will be risk of falling (the proportion of fallers per group), falls rate relative to activity exposure, hospitalisation for fall-related injury, change in gait variability, volume and patterns of ambulatory activity and change in physical performance assessed at baseline, 6 and 12 months. Cost effectiveness will be examined using intervention and health service costs. The trial commenced recruitment on 31 November 2018. Discussion This study evaluates the efficacy and cost effectiveness of a progressive strength and balance exercise program for aged-care residents to reduce falls. The outcomes will aid development of evidenced-based exercise programs for this vulnerable population.

scholarly journals Effects of a Synbiotic Formula on Functional Bowel Disorders and Gut Microbiota Profile during Long-Term Home Enteral Nutrition (LTHEN): A Pilot Study

Nutrients ◽  
2020 ◽  
Vol 13 (1) ◽  
pp. 87
Author(s):  
Valentina D’Onofrio ◽  
Federica Del Chierico ◽  
Paola Belci ◽  
Pamela Vernocchi ◽  
Andrea Quagliariello ◽  
...  
Keyword(s):  
Enteral Nutrition ◽  
Gut Microbiota ◽  
Intervention Group ◽  
Short Chain Fatty Acids ◽  
Stool Consistency ◽  
Control Group ◽  
Open Label ◽  
Intestinal Functions ◽  
Enteral Formula

Long-term enteral nutrition (LTEN) can induce gut microbiota (GM) dysbiosis and gastrointestinal related symptoms, such as constipation or diarrhoea. To date, the treatment of constipation is based on the use of laxatives and prebiotics. Only recently have probiotics and synbiotics been considered, the latter modulating the GM and regulating intestinal functions. This randomized open-label intervention study evaluated the effects of synbiotic treatment on the GM profile, its functional activity and on intestinal functions in long-term home EN (LTHEN) patients. Twenty LTHEN patients were recruited to take enteral formula plus one sachet/day of synbiotic (intervention group, IG) or enteral formula (control group, CG) for four months and evaluated for constipation, stool consistency, and GM and metabolite profiles. In IG patients, statistically significant reduction of constipation and increase of stool consistency were observed after four months (T1), compared to CG subjects. GM ecology analyses revealed a decrease in the microbial diversity of both IC and CG groups. Biodiversity increased at T1 for 5/11 IG patients and Methanobrevibacter was identified as the biomarker correlated to the richness increase. Moreover, the increase of short chain fatty acids and the reduction of harmful molecules have been correlated to synbiotic administration. Synbiotics improve constipation symptoms and influences Methanobrevibacter growth in LTHEN patients.

scholarly journals Effectiveness and Cost of Organized Outreach for Colorectal Cancer Screening: A Randomized, Controlled Trial

2019 ◽  
Vol 112 (3) ◽  
pp. 305-313 ◽  
Author(s):  
Ma Somsouk ◽  
Carly Rachocki ◽  
Ajitha Mannalithara ◽  
Dianne Garcia ◽  
Victoria Laleau ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Economies Of Scale ◽  
Intervention Group ◽  
Safety Net ◽  
Additional Patient ◽  
Control Group ◽  
Crc Screening

Abstract Background Colorectal cancer (CRC) screening remains underused, especially in safety-net systems. The objective of this study was to determine the effectiveness, costs, and cost-effectiveness of organized outreach using fecal immunochemical tests (FITs) compared with usual care. Methods Patients age 50–75 years eligible for CRC screening from eight participating primary care safety-net clinics were randomly assigned to outreach intervention with usual care vs usual care alone. The intervention included a mailed postcard and call, followed by a mailed FIT kit, and a reminder phone call if the FIT kit was not returned. The primary outcome was screening participation at 1 year and a microcosting analysis of the outreach activities with embedded long-term cost-effectiveness of outreach. All statistical tests were two-sided. Results A total of 5386 patients were randomly assigned to the intervention group and 5434 to usual care. FIT screening was statistically significantly higher in the intervention group than in the control group (57.9% vs 37.4%, P < .001; difference = 20.5%, 95% confidence interval = 18.6% to 22.4%). In the intervention group, FIT completion rate was higher in patients who had previously completed a FIT vs those who had not (71.9% vs 35.7%, P < .001). There was evidence of effect modification of the intervention by language, and clinic. Outreach cost approximately $23 per patient and $112 per additional patient screened. Projecting long-term outcomes, outreach was estimated to cost $9200 per quality-adjusted life-year gained vs usual care. Conclusion Population-based management with organized FIT outreach statistically significantly increased CRC screening and was cost-effective in a safety-net system. The sustainability of the program and any impact of economies of scale remain to be determined.

scholarly journals Eight-Year Post-Trial Follow-up of Morbidity and Mortality of Telephone Health Coaching

2021 ◽  
Author(s):  
Erja Mustonen ◽  
Iiris Hörhammer ◽  
Kristiina Patja ◽  
Pilvikki Absetz ◽  
Johanna Lammintakanen ◽  
...  
Keyword(s):  
Heart Failure ◽  
Primary Outcome ◽  
Intervention Group ◽  
Health Coaching ◽  
Control Group ◽  
Mortality And Morbidity ◽  
Intention To Treat ◽  
Post Trial

Abstract Background: Health coaching is a patient-centred approach to supporting self-management for the chronic conditions. However, long-term evidence of effectiveness of health coaching remains scarce. The object of this study was to evaluate the long-term effect of telephone health coaching (THC) on mortality and morbidity among people with type 2 diabetes (T2D), coronary artery disease (CAD) and congestive heart failure (CHF) with a population of 112,000 in Finland.Methods: 1535 T2D, CAD and CHF patients with unmet treatment targets were randomly allocated to receive usual health care (control group, n = 501) or a combination of usual care and individual THC for 12 months (intervention group, n = 1034). The primary outcome was a composite of death from cardiovascular causes, non-fatal stroke, non-fatal myocardial infarction (AMI) or unstable angina pectoris (UAP) during a follow-up of eight years. Three other composite variables were also followed; cardiovascular mortality or morbidity, events of death from any cause, non-fatal AMI, non-fatal stroke, renal insufficiency, peripheral vascular disease and hospitalization due to congestive heart failure (CHF). Randomized controlled trial (RCT) data was linked to Finnish national health and social care registries and electronic health records (EHR). Post-trial eight-year evaluation was conducted using intention-to-treat (ITT) and per-protocol (PP) analysis. Results: The composite primary outcome event rate per 100 person years was lower in the intervention group (3.45) than in control group (3.88) in ITT -analysis, but the difference was not statistically significant (hazard ratio in the intervention group 0.87; 95% CI, 0.71 to 1.07; P = 0.19). In the subgroup (T2D, CAD/CHF) analysis, there were no statistically significant effects. The secondary PP-analysis showed statistically significant benefits for those who participated to the study. Conclusions: No statistically significant effect of health coaching on mortality and morbidity was found in intention to treat analysis. The results suggest, however, that the intervention may be effective among patients who are willing and able to participate in health coaching. More research is needed to identify patients most likely to benefit from low-intensity health coaching. Trial registration: NCT00552903 (registration date: the 1st of November 2007, updated the 3rd of February 2009)

scholarly journals Eight-year post-trial follow-up of morbidity and mortality of telephone health coaching

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Erja Mustonen ◽  
Iiris Hörhammer ◽  
Kristiina Patja ◽  
Pilvikki Absetz ◽  
Johanna Lammintakanen ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Intervention Group ◽  
Health Coaching ◽  
Control Group ◽  
Mortality And Morbidity ◽  
Intention To Treat ◽  
Composite Endpoints ◽  
Post Trial

Abstract Background Health coaching is a patient-centred approach to supporting self-management for the chronic conditions. However, long-term evidence of effectiveness of health coaching remains scarce. The object of this study was to evaluate the long-term effect of telephone health coaching (THC) on mortality and morbidity among people with type 2 diabetes (T2D), coronary artery disease (CAD) and congestive heart failure (CHF).. Methods 1535 T2D, CAD and CHF patients with unmet treatment targets were randomly allocated into an intervention group (n = 1034) and control group (n = 501). Intervention group received monthly individual strength-based, autonomy supportive THC sessions (average 30 min) for behavior change with a specially trained nurse for 12 months additional to usual health care. Control group received usual health care services. The primary outcome was a composite of death from cardiovascular causes or non-fatal stroke or non-fatal myocardial infarction (AMI) or unstable angina pectoris (UAP) during a follow-up of 8 years Three other composite endpoints with distinct combinations of fatal and non-fatal cardiovascular events and death from any cause were used as secondary outcomes. Other outcomes followed were the most relevant components of the composite endpoints. Randomized controlled trial (RCT) data was linked to Finnish national health and social care registries and electronic health records (EHR). Post-trial eight-year evaluation was conducted using intention-to-treat (ITT) and per-protocol (PP) analysis. Results The composite primary outcome event rate per 100 person years was lower in the intervention group (3.45) than in control group (3.88) in ITT -analysis, but the difference was not statistically significant (hazard ratio in the intervention group 0.87; 95% CI, 0.71 to 1.07; P = 0.19). In the subgroup (T2D, CAD/CHF) analysis, there were no statistically significant effects. The secondary PP-analysis showed statistically significant benefits for those who participated in the study. Conclusions No statistically significant effect of health coaching on mortality and morbidity was found in intention to treat analysis. The per protocol results suggest, however, that the intervention may be effective among patients who are willing and able to participate in health coaching. More research is needed to identify patients most likely to benefit from low-intensity health coaching. Trial registration NCT00552903 (registration date: the 1st of November 2007, updated the 3rd of February 2009).

scholarly journals Clinician-delivered Intervention to Facilitate Tobacco Quitline Use by Surgical Patients

2011 ◽  
Vol 114 (4) ◽  
pp. 847-855 ◽  
Author(s):  
David O. Warner ◽  
Robert C. Klesges ◽  
Lowell C. Dale ◽  
Kenneth P. Offord ◽  
Darrell R. Schroeder ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Primary Outcome ◽  
Elective Surgery ◽  
Intervention Group ◽  
Surgical Patients ◽  
Control Group ◽  
Counseling Session ◽  
Smoking Intervention ◽  
Continuous Abstinence

Background Telephone quitlines that provide counseling support are efficacious in helping cigarette smokers quit and have been widely disseminated; currently, they are underused. Surgery represents a teachable moment for smoking cessation, which can benefit surgical outcomes; however, few surgical patients receive smoking cessation interventions. This study developed and tested a clinician-delivered intervention to facilitate quitline use by adult patients scheduled for elective surgery. Methods After formative work involving patients and clinicians, a brief intervention was designed to facilitate telephone quitline use. It was then evaluated in a randomized trial of 300 adults scheduled for elective surgery. A control standard brief stop-smoking intervention served as a comparator, with both interventions delivered by clinicians. The primary outcome was the use rate of a quitline accessed through a dedicated toll-free telephone number, with use defined as completing at least one full counseling session. Secondary outcomes included self-reported abstinence from cigarettes at 30 and 90 days postoperatively. Results Subject characteristics were similar between the two groups. Records from the designated quitline documented that 29 of 149 subjects (19.5%) in the quitline intervention group and 0 of 151 subjects in the control group completed the first full counseling session (P < 0.0001). There were no significant differences in the self-reported point-prevalent and continuous abstinence rates between groups at either 30 or 90 days postoperatively, although rates tended to be higher in the quitline intervention group. Conclusions Clinicians can effectively facilitate quitline use by surgical patients. Further work is necessary to evaluate the efficacy of this approach in terms of long-term abstinence from cigarette smoking.

The Cost-Effectiveness of Rituximab, Cyclophosphamide, Vincristine and Prednisolone (RCVP) Compared with CVP for the Treatment of Follicular Non-Hodgkin’s Lymphoma (NHL) in the UK.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 345-345 ◽  
Author(s):  
Gavin Lewis ◽  
Robert E. Marcus ◽  
Stephen J. Proctor ◽  
Marlene Gyldmark ◽  
James Creeden ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Health Service ◽  
Life Expectancy ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
The Uk ◽  
First Line Treatment ◽  
Health Service Costs

Abstract Background: A large phase III randomised control trial (Marcus et al, Blood2005, 105;4) has demonstrated that rituximab plus CVP compared with CVP alone improved time to treatment failure (p<0.0001) and a trend towards overall survival benefit (p=0.06). No analysis has yet been published relating to long-term clinical outcomes and costs of adding rituximab as a first-line treatment. Cost-effectiveness (CE) analysis aims to evaluate the additional costs and patient benefits (expressed as quality adjusted life years – QALYs) of an intervention (RCVP) compared with an alternative intervention (CVP). Some healthcare systems have CE thresholds to judge if the incremental cost-effectiveness ratio (ICER) is within acceptable limits; these thresholds vary across countries. Aims: To estimate the long-term clinical outcomes, direct health-service costs and incremental CE of RCVP compared with CVP for the first-line treatment of patients with follicular NHL. Methods: A CE analysis was developed using a state-transition Markov model, which simulated the lifetime progression of follicular NHL patients. Baseline patient characteristics were assumed equal to those in the Marcus et al study, with a mean age of 53. The CE of RCVP was evaluated using an ICER, based upon the UK health-service perspective. The model starts from the time of receiving first treatment until death. Patients could be in one of 3 discrete health states: progression-free survival, progression or death. The risk of disease progression for RCVP and CVP patients was derived directly from the results of the Marcus et al study, based upon a median trial follow-up of 42 months. The risk of death following disease progression was based upon outcomes reported by a UK registry of second-line follicular NHL patients (n=249). Patient quality of life was incorporated within the analysis using utility scores for each health state from a survey of follicular NHL patients (n=165) who completed the EQ-5D questionnaire. Cost and QALYs were discounted at 3.5%. Costs for patient monitoring and drug costs for second-line and later treatments were taken from published literature. Second-line and later treatments were assumed equivalent in both arms of the model. Results: Over the lifetime of a patient rituximab as a first-line treatment strategy generated higher total costs, but greater QALYs, compared with CVP alone. The average lifetime health-service costs per patient were £20,347 ($37,650) and £9,977 ($18,462) per patient for RCVP and CVP, respectively. Life expectancy was estimated as 9.4 yrs for RCVP and 7.2 yrs for CVP (undiscounted). Average QALYs for RCVP and CVP were 5.7 and 4.5 per patient, respectively (undiscounted). The ICER (discounted) of RCVP compared with CVP was £8,290 ($15,340) per QALY. Although there is uncertainty associated with the progression of follicular lymphoma and treatment costs, the ICER did not exceed £21,500 ($39,784) despite a wide variation in each parameter used in the analysis. Conclusions: Rituximab in combination with CVP is a cost-effective treatment option for the first-line treatment of follicular NHL. The clinical advantages of RCVP compared with CVP alone are predicted to generate an increase in life expectancy and QALYs. The resulting ICER for RCVP is well within the UK threshold of CE.

scholarly journals Healthy eating and lifestyle in pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum

2021 ◽  
Author(s):  
Sharon A. Simpson ◽  
Elinor Coulman ◽  
Dunla Gallagher ◽  
Karen Jewell ◽  
David Cohen ◽  
...  
Keyword(s):  
Weight Management ◽  
Healthy Eating ◽  
Primary Outcome ◽  
Intervention Group ◽  
Control Group ◽  
Risky Drinking ◽  
Management Intervention ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Weight Management Intervention

Abstract Objective To assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth. Methods Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined. Interventions Women attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy. Results Mean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was −0.02 (95% CI −0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p < 0.04), improved fibre score (3.22, 1.07 to 5.37, p < 0.01) and lower levels of risky drinking at 12 months postpartum compared to the control group (OR 0.45, 0.27 to 0.74, p < 0.002). The net incremental monetary benefit was not statistically significantly different between arms, although the probability of the intervention being cost-effective was above 60%, at policy-relevant thresholds. Conclusions There was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking. Trial registration: Current Controlled Trials ISRCTN25260464.

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