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

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.

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Colon capsule endoscopy in colorectal cancer screening: a randomised controlled trial

BMJ Open Gastroenterology ◽

10.1136/bmjgast-2020-000411 ◽

2020 ◽

Vol 7 (1) ◽

pp. e000411

Author(s):

Lasse Kaalby ◽

Ulrik Deding ◽

Morten Kobaek-Larsen ◽

Anne-Line Volden Havshoi ◽

Erik Zimmermann-Nielsen ◽

...

Keyword(s):

Colorectal Cancer ◽

Capsule Endoscopy ◽

Data Protection ◽

Screening Programme ◽

Intervention Group ◽

Control Group ◽

Economic Implications ◽

Crc Screening ◽

Colon Capsule Endoscopy ◽

Colon Capsule

IntroductionThe use of capsule endoscopy has become an approved method in small bowel diagnostics, but the same level of integration is not seen in large bowel diagnostics. We will use colon capsule endoscopy (CCE) as a filter test in colorectal cancer (CRC) screening between the faecal immunochemical test (FIT) and colonoscopy. We aim to investigate the clinical performance, population acceptability, and economic implications of the procedure in a large-scale clinical trial.Methods and analysisWe will randomly allocate 124 214 Danish citizens eligible for participation in the national CRC screening programme within the Region of Southern Denmark to either an intervention group or a control group. Prior to submitting a FIT, citizens randomised to the intervention group will be informed about their opportunity to undergo CCE, instead of colonoscopy, if the FIT is positive. Suspected cancers; >3 adenomas <10 mm in size, 1 adenoma >10 mm in size or >4 adenomas regardless of size, detected during CCE will generate an invitation to colonoscopy as per regular screening guidelines, whereas citizens with suspected low risk polyps will re-enter the biennial screening programme. Citizens with no CCE findings will be excluded from screening for 8 years. In the control group, citizens will follow standard screening procedures.Ethics and disseminationAll participants must consent prior to capsule ingestion. All collected data will be handled and stored in accordance with current data protection legislation. Approvals from the regional ethics committee (ref. S-20190100) and the Danish data protection agency have been obtained (ref. 19/29858).Trial registration detailsThe study has been registered with ClinicalTrials.gov under: NCT04049357.

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

BMC Medicine ◽

10.1186/s12916-021-01933-6 ◽

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

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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

10.21203/rs.2.15840/v2 ◽

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.

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Surgical treatment for colorectal cancer: analysis of the influence of an enhanced recovery programme on long-term oncological outcomes—a study protocol for a prospective, multicentre, observational cohort study

BMJ Open ◽

10.1136/bmjopen-2020-040316 ◽

2020 ◽

Vol 10 (10) ◽

pp. e040316

Author(s):

Jose-M Ramirez-Rodriguez ◽

Javier Martinez-Ubieto ◽

Jose-L Muñoz-Rodes ◽

Jose-R Rodriguez-Fraile ◽

Jose-A Garcia-Erce ◽

...

Keyword(s):

Quality Of Life ◽

Colorectal Cancer ◽

Cohort Study ◽

Enhanced Recovery ◽

Intervention Group ◽

Rank Test ◽

Control Group ◽

The Impact

IntroductionThe evidence currently available from enhanced recovery after surgery (ERAS) programmes concerns their benefits in the immediate postoperative period, but there is still very little evidence as to whether their correct implementation benefits patients in the long term. The working hypothesis here is that, due to the lower response to surgical aggression and lower rates of postoperative complications, ERAS protocols can reduce colorectal cancer-related mortality. The main objective of this study is to analyse the impact of an ERAS programme for colorectal cancer on 5-year survival. As secondary objectives, we propose to analyse the weight of each of the predefined items in the oncological results as well as the quality of life.Methods and analysisA multicentre prospective cohort study was conducted in patients older than 18 years of age who are scheduled to undergo surgery for colorectal cancer. The study involved 12 hospitals with an implemented enhanced recovery protocol according to the guidelines published by the Spanish National Health Service. The intervention group includes patients with a minimum implementation level of 70%, and the control group includes those who fail to reach this level. Compliance will be studied using 18 key performance indicators, and the results will be analysed using cancer survival indicators, including overall survival, cancer-specific survival and relapse-free survival. The time to recurrence, perioperative morbidity and mortality, hospital stay and quality of life will also be studied, the latter using the validated EuroQol Five questionnaire. The propensity index method will be used to create comparable treatment and control groups, and a multivariate regression will be used to study each variable. The Kaplan-Meier estimator will be used to estimate survival and the log-rank test to make comparisons. A p value of less than 0.05 (two-tailed) will be considered to be significant.Ethics and disseminationEthical approval for this study was obtained from the Aragon Ethical Committee (C.P.-C.I. PI20/086) on 4 March 2020. The findings of this study will be submitted to peer-reviewed journals (BMJ Open, JAMA Surgery, Annals of Surgery, British Journal of Surgery). Abstracts will be submitted to relevant national and international meetings.Trial registration numberNCT04305314.

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Directly Mailing gFOBT Kits to Previous Responders Being Recalled for Colorectal Cancer Screening Increases Participation

Journal of the Canadian Association of Gastroenterology ◽

10.1093/jcag/gwz012 ◽

2019 ◽

Vol 3 (5) ◽

pp. 197-203

Author(s):

Jill Tinmouth ◽

Jigisha Patel ◽

Peter C Austin ◽

Nancy N Baxter ◽

Melissa C Brouwers ◽

...

Keyword(s):

Colorectal Cancer ◽

Primary Care ◽

Care Provider ◽

Primary Care Provider ◽

Intervention Group ◽

Absolute Difference ◽

Control Group ◽

Fecal Occult Blood ◽

Average Risk ◽

Crc Screening

Abstract Background Colorectal cancer (CRC) screening with guaiac fecal occult blood test (gFOBT) reduces CRC-related death. Average risk individuals should be recalled for screening with gFOBT every 2 years in order to maximize effectiveness. However, adherence with repeated testing is often suboptimal. Our aim was to evaluate whether adding a gFOBT kit to a mailed recall letter improves participation compared with a mailed recall letter alone, among previous responders to a mailed invitation. Methods We conducted a cluster randomized controlled trial, with the primary care provider as the unit of randomization. Eligible patients had completed a gFOBT and tested negative in an earlier pilot study and were now due for recall. The intervention group received a mailed CRC screening recall letter from their primary care provider plus a gFOBT kit (n = 431) while the control group received a mailed CRC screening mailed recall letter alone (n = 452). The primary outcome was the uptake of gFOBT or colonoscopy within 6 months. Results gFOBT uptake was higher in the intervention group (61.3%, n = 264) compared with the control group (50.4%, n = 228) with an absolute difference between the two groups of 10.8% (95% confidence interval [CI]: 1.4 to 20.2%, P = <0.01). Patients in the intervention group were more likely to complete the gFOBT compared with the control group (odds ratio [OR] = 1.4; 95% CI: 1.1 to 1.9). Conclusion Our findings show that adding gFOBT kits to the mailed recall letter increased participation among persons recalled for screening. Nine gFOBT kits would have to be sent by mail in order to screen one additional person.

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Effectiveness and Estimation of Cost-Effectiveness of a Group-Based Multicomponent Physical Exercise Programme on Risk of Falling and Frailty in Community-Dwelling Older Adults

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph16122086 ◽

2019 ◽

Vol 16 (12) ◽

pp. 2086 ◽

Cited By ~ 3

Author(s):

Tamara Alhambra-Borrás ◽

Estrella Durá-Ferrandis ◽

Maite Ferrando-García

Keyword(s):

Older Adults ◽

Cost Effectiveness ◽

Physical Exercise ◽

Usual Care ◽

Intervention Group ◽

Exercise Programme ◽

Community Dwelling ◽

Control Group ◽

Risk Of Falling ◽

Community Dwelling Older Adults

This study analyses the effectiveness and cost-effectiveness of a group-based multicomponent physical exercise programme aimed at reducing the risk of falling and frailty in community-dwelling older adults. This is a pretest–posttest non-equivalent control group design, with an intervention group and a comparison group. Participants were evaluated at baseline and after 9 months. The effectiveness analyses showed significant reduction in the risk of falling (−45.5%; p = 0.000) and frailty (−31%; p = 0.000) after the intervention for the participants in the physical exercise programme. Moreover, these participants showed an improvement in limitations in activities of daily living, self-care ability and the use of health resources, physical performance, balance and body mass index. The cost-effectiveness analyses showed that the intervention was cost-saving and more effective than usual care scenario. A novel group-based multicomponent physical exercise programme showed to be more effective and cost-effective than usual care for older adults suffering from risk of falling and frailty.

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Effects of Screening for Colorectal Cancer: Development and Validation of a Multistate Markov Model

10.1101/2020.04.17.20069484 ◽

2020 ◽

Cited By ~ 1

Author(s):

Thomas Heisser ◽

Michael Hoffmeister ◽

Hermann Brenner

Keyword(s):

Colorectal Cancer ◽

Markov Model ◽

Time Course ◽

Intervention Group ◽

Medical Decision ◽

Screening Colonoscopy ◽

Control Group ◽

German Population ◽

Crc Screening ◽

Incidence And Mortality

AbstractSimulation models are a powerful tool to overcome gaps of evidence needed to inform medical decision making. Here, we present development and application of a multistate Markov model to simulate effects of colorectal cancer (CRC) screening, along with a thorough assessment of the model’s ability to reproduce real-life outcomes. Firstly, we provide a comprehensive documentation of the model development, structure and assumptions. Secondly, to assess the model’s external validity, we compared model-derived cumulative incidence and prevalences of colorectal neoplasms to (1) results from KolosSal, a study in German screening colonoscopy participants, (2) registry-based estimates of CRC incidence in Germany, and (3) outcome patterns of randomized sigmoidoscopy screening studies. We found that (1) more than 90% of model-predicted neoplasm prevalences were within the 95% confidence intervals of the observed prevalences in the KolosSal study; (2) the 15-year cumulative CRC incidences estimated by simulations for the German population deviated by 0.0-0.2 percent units in men and 0.0-0.3 percent units in women when compared to corresponding registry-derived estimates; and (3) the time course of cumulative CRC incidence and mortality in the modelled intervention group and control group closely resembles the time course reported from sigmoidoscopy screening trials. Summarized, our model adequately predicted colorectal neoplasm prevalences and incidences in a German population for up to 25 years, with estimated patterns of the effect of screening colonoscopy resembling those seen in registry data and real-world studies. This suggests that the model represents a valid tool to assess the comparative effectiveness of strategies for CRC screening.

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Nicotine preloading for smoking cessation: the Preloading RCT

Health Technology Assessment ◽

10.3310/hta22410 ◽

2018 ◽

Vol 22 (41) ◽

pp. 1-84 ◽

Cited By ~ 2

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.

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Cost-effectiveness analysis of systematic fast-track transition from oncological treatment to specialised palliative care at home for patients and their caregivers: the DOMUS trial

BMC Palliative Care ◽

10.1186/s12904-020-00645-7 ◽

2020 ◽

Vol 19 (1) ◽

Author(s):

Christine Marie Bækø Halling ◽

Rasmus Trap Wolf ◽

Per Sjøgren ◽

Hans Von Der Maase ◽

Helle Timm ◽

...

Keyword(s):

Cost Effectiveness ◽

Usual Care ◽

Fast Track ◽

Psychological Intervention ◽

Intervention Group ◽

Control Group ◽

Incurable Cancer ◽

Oncological Treatment ◽

Link Type ◽

At Home

Abstract Background While hospitals remain the most common place of death in many western countries, specialised palliative care (SPC) at home is an alternative to improve the quality of life for patients with incurable cancer. We evaluated the cost-effectiveness of a systematic fast-track transition process from oncological treatment to SPC enriched with a psychological intervention at home for patients with incurable cancer and their caregivers. Methods A full economic evaluation with a time horizon of six months was performed from a societal perspective within a randomised controlled trial, the DOMUS trial (Clinicaltrials.gov: NCT01885637). The primary outcome of the health economic analysis was a incremental cost-effectiveness ratio (ICER), which is obtained by comparing costs required per gain in Quality-Adjusted Life Years (QALY). The costs included primary and secondary healthcare costs, cost of intervention and informal care from caregivers. Public transfers were analysed in seperate analysis. QALYs were measured using EORTC QLQ-C30 for patients and SF-36 for caregivers. Bootstrap simulations were performed to obtain the ICER estimate. Results In total, 321 patients (162 in intervention group, 159 in control group) and 235 caregivers (126 in intervention group, 109 in control group) completed the study. The intervention resulted in significantly higher QALYs for patients when compared to usual care (p-value = 0.026), while being more expensive as well. In the 6 months observation period, the average incremental cost of intervention compared to usual care was €2015 per patient (p value < 0.000). The mean incremental gain was 0.01678 QALY (p-value = 0.026). Thereby, the ICER was €118,292/QALY when adjusting for baseline costs and quality of life. For the caregivers, we found no significant differences in QALYs between the intervention and control group (p-value = 0.630). At a willingness to pay of €80,000 per QALY, the probability that the intervention is cost-effective lies at 15% in the base case scenario. Conclusion This model of fast-track SPC enriched with a psychological intervention yields better QALYs than usual care with a large increase in costs. Trial registration The trial was prospectively registered 25.6.2013. Clinicaltrials.gov Identifier: NCT01885637.

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Cost-Effectiveness Analysis of an Interdisciplinary Lifestyle Intervention Targeting Women With Obesity and Infertility in Comparison to Usual Care

Journal of the Endocrine Society ◽

10.1210/jendso/bvab048.1485 ◽

2021 ◽

Vol 5 (Supplement_1) ◽

pp. A730-A730

Author(s):

Matea Belan ◽

Belina Carranza-Mamane ◽

Youssef AinMelk ◽

Marie-Helene Pesant ◽

Farrah Jean-Denis ◽

...

Keyword(s):

Cost Effectiveness ◽

Usual Care ◽

Lifestyle Intervention ◽

Intervention Group ◽

Cost Effectiveness Analysis ◽

Administrative Databases ◽

Absolute Difference ◽

Control Group ◽

Effectiveness Analysis ◽

Care Protocol

Abstract Although lifestyle modification is considered as the first-line treatment for women with obesity and infertility, these women generally do not have access to a program supporting them in adopting healthy habits that is integrated to fertility care. Implementing such a program requires to demonstrate its efficiency. The purpose of this study was to conduct a cost-effectiveness analysis (CEA) of an interdisciplinary lifestyle intervention (Fit-for-Fertility (FFF) program) for women with obesity and infertility, in comparison with the usual care protocol, i.e. fertility treatments. Methods: A CEA was conducted alongside a randomized controlled trial, recruiting women at the fertility clinic of the Centre hospitalier universitaire de Sherbrooke. Women were randomized to: i) the intervention group (IG): FFF program alone for 6 months (individual follow-ups every 6 weeks and 12 group sessions), and in combination with usual care for infertility after 6 months if not pregnant; or ii) control group (CG): usual care from the outset. Data were collected in both groups, during 18 months or until the end of the pregnancy for those who became pregnant. Costs related to the management of infertility, obesity, pregnancy and childbirth, and the FFF program were considered and collected by self-reported questionnaires, review of medical records and administrative databases. Live birth (LB) rate was used to assess effectiveness. The CEA’s parameter of interest was the incremental cost-effectiveness ratio (ICER), calculated by non-parametric bootstrap with 5,000 iterations. All costs are in Canadian dollars, 2019. Results: A total of 130 women were randomized (65 CG, 65 IG). We present results for the 108 women (57 CG, 51 IG) who completed at least 6 months in the study. We observed an absolute difference of 14.2% (p=0.328) in LB rate between groups (IG: 51.0%; CG: 36.8%). Total mean costs per patient were significantly higher in the IG vs the CG for healthcare system’s ($5,660 ± $3,200 vs $3,631 ± $3,389; p=0.002) and society’s ($9,745 ± $5,899 vs $6,898 ± 7,021; p=0.026) perspectives. We observed an ICER of $12,633 per additional LB [$5,319-$19,947] from the healthcare system’s perspective, and $5,980 [$3,086-$8 874] from the patients’ perspective. Overall, the ICER for the society’s perspective, which includes both previous perspectives, was estimated at $24,393 per additional LB [$15,509-$33,276]. Conclusion: According to our results, a lifestyle intervention may be clinically more effective than the usual protocol of care for women with obesity and infertility, but generates higher costs as well, resulting in a positive ICER (of $12,600 per additional life birth for the healthcare system). Such an intervention could be considered efficient compared to the usual standard of care, but studies are needed to assess the willingness to pay of stakeholders for this type of intervention.

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