Cost-effectiveness analysis of procalcitonin and lung ultrasonography guided antibiotic prescriptions in primary care.

Antimicrobial resistance comes with high morbidity and mortality burden, and ultimately high impact on healthcare and social costs. Efficient strategies are needed to limit antibiotic overuse. This paper investigates the cost-effectiveness of testing patients with lower respiratory tract infection with procalcitonin, either at the point-of-care only or combined with lung ultrasonography. These diagnostic tools help detect the presence of bacterial pneumonia, guiding prescription decisions. The clinical responses of these strategies were studied in the primary care setting. Evidence is needed on their cost-effectiveness. We used data from a cluster-randomized bi-centric clinical trial conducted in Switzerland and estimated patient-level costs using data on resource use to which we applied Swiss tariffs. Combining the incremental costs of the two strategies and the reduction in the 28-days antibiotic prescription rate (APR) compared to usual care, we calculated Incremental Cost-Effectiveness Ratios (ICER). We also used the Cost-Effectiveness Acceptability Curve as an analytical decision-making tool. The robustness of the findings is ensured by Probabilistic Sensitivity Analysis and scenario analysis. In the base case scenario, the ICER compared to usual care is $2.3 per percentage point (pp) reduction in APR for the procalcitonin group, and $4.4 for procalcitonin-ultrasound combined. Furthermore, we found that for a willingness to pay per patient of more than $2 per pp reduction in the APR, procalcitonin is the strategy with the highest probability to be cost-effective. Our findings suggest that testing patients with respiratory symptoms with procalcitonin to guide antibiotic prescription in the primary care setting represents good value for money.

Does the introduction of an infliximab biosimilar always result in savings for hospitals? A descriptive study using real-world data.

BACKGROUND: Biosimilars are biologic drugs that have the potential to increase the efficiency of healthcare spending and curb drug-related cost increases. However, their introduction into hospital formularies through initiatives such as non-medical switching must be carefully orchestrated so as not to cause treatment discontinuation or result in increased health resource utilization, such as additional visits or laboratory tests, among others. This retrospective cohort study aims to assess the impact of the introduction of CT-P13 on the healthcare expenditures of patients who were treated with originator infliximab or CT-P13. METHODS: Gastroenterology, immunoallergology and rheumatology patients treated between September 2017 and December 2020 at a university hospital in Western Switzerland were included and divided into seven cohorts, based on their treatment pathway (i.e., use and discontinuation of CT-P13 and/or originator infliximab). Costs in Swiss francs were obtained from the hospital's cost accounting department and length of stay was extracted from inpatient records. Comparisons of costs and length of stay between cohorts were calculated by bootstrapping. RESULTS: Sixty immunoallergology, 84 rheumatology and 114 gastroenterology patients were included. Inpatient and outpatient costs averaged (sd) CHF 1,611 (1,020) per hospital day and CHF 4,991 (6,931) per infusion, respectively. The mean (sd) length of stay was 20 (28) days. Although immunoallergology and rheumatology patients had higher average costs than gastroenterology patients, differences in costs and length of stay were not formally explained by treatment pathway. Differences in health resource utilization were marginal. CONCLUSIONS: The introduction of CT-P13 and the disruption of patient treatment management were not associated with differences in average outpatient and inpatient costs and length of stay, in contrast to the results reported in the rest of the literature. Future research should focus on the cost-effectiveness of non-medical switching policies and the potential benefits for patients.

Preferences for innovations in healthcare delivery models in the Swiss elderly population: a latent class, choice modelling study.

BACKGROUND: With the increasing number of people affected by multiple chronic conditions, it is essential for public-health professionals to promote strategies addressing patient needs for coordinated care. We aim to explore preference heterogeneity for better-coordinated care delivery models in Swiss older adults, and identify profiles of individuals more open to healthcare reforms. METHODS: A DCE (discrete choice experiment) survey was developed online and on paper for the Swiss adults aged 50+, following best practice. To elicit preferences, we estimated a latent class model allowing grouping individuals with similar preferences into distinct classes, and examined what background characteristics contributed to specific class membership. RESULTS: The optimal model identified three classes with different openness to reforms. Class 1 (49%) members were concerned with premium increases and were in favour of integrated care structures with care managed by interprofessional teams. Individuals in class 2 (19%) were younger, open to reforms, and expressed the needs for radical changes within the Swiss healthcare system. Class 3 respondents (32%) were strongly reluctant to changes. CONCLUSIONS: Our study goes beyond average preferences and identifies three distinct population profiles, a majority open to reforms on specific aspects of care delivery, a smallest group in favour radical changes, and a third strongly against changes. Therefore, tailored approaches around healthcare reforms are needed, e.g. explaining the role of interprofessional teams in coordinating care, electronic health records and insurance premium variation.

PLUS-IS-LESS project: Procalcitonin and Lung UltraSonography-based antibiotherapy in patients with Lower rESpiratory tract infection in Swiss Emergency Departments: study protocol for a pragmatic stepped-wedge cluster-randomized trial.

BACKGROUND: Lower respiratory tract infections (LRTIs) are among the most frequent infections and a significant contributor to inappropriate antibiotic prescription. Currently, no single diagnostic tool can reliably identify bacterial pneumonia. We thus evaluate a multimodal approach based on a clinical score, lung ultrasound (LUS), and the inflammatory biomarker, procalcitonin (PCT) to guide prescription of antibiotics. LUS outperforms chest X-ray in the identification of pneumonia, while PCT is known to be elevated in bacterial and/or severe infections. We propose a trial to test their synergistic potential in reducing antibiotic prescription while preserving patient safety in emergency departments (ED). METHODS: The PLUS-IS-LESS study is a pragmatic, stepped-wedge cluster-randomized, clinical trial conducted in 10 Swiss EDs. It assesses the PLUS algorithm, which combines a clinical prediction score, LUS, PCT, and a clinical severity score to guide antibiotics among adults with LRTIs, compared with usual care. The co-primary endpoints are the proportion of patients prescribed antibiotics and the proportion of patients with clinical failure by day 28. Secondary endpoints include measurement of change in quality of life, length of hospital stay, antibiotic-related side effects, barriers and facilitators to the implementation of the algorithm, cost-effectiveness of the intervention, and identification of patterns of pneumonia in LUS using machine learning. DISCUSSION: The PLUS algorithm aims to optimize prescription of antibiotics through improved diagnostic performance and maximization of physician adherence, while ensuring safety. It is based on previously validated tests and does therefore not expose participants to unforeseeable risks. Cluster randomization prevents cross-contamination between study groups, as physicians are not exposed to the intervention during or before the control period. The stepped-wedge implementation of the intervention allows effect calculation from both between- and within-cluster comparisons, which enhances statistical power and allows smaller sample size than a parallel cluster design. Moreover, it enables the training of all centers for the intervention, simplifying implementation if the results prove successful. The PLUS algorithm has the potential to improve the identification of LRTIs that would benefit from antibiotics. When scaled, the expected reduction in the proportion of antibiotics prescribed has the potential to not only decrease side effects and costs but also mitigate antibiotic resistance. TRIAL REGISTRATION: This study was registered on July 19, 2022, on the ClinicalTrials.gov registry using reference number: NCT05463406. TRIAL STATUS: Recruitment started on December 5, 2022, and will be completed on November 3, 2024. Current protocol version is version 3.0, dated April 3, 2023.

Potentially avoidable hospitalizations and socioeconomic status in Switzerland: A small area-level analysis.

The Swiss healthcare system is well known for the quality of its healthcare and population health but also for its high cost, particularly regarding out-of-pocket expenses. We conduct the first national study on the association between socioeconomic status and access to community-based ambulatory care (CBAC). We analyze administrative and hospital discharge data at the small area level over a four-year time period (2014 - 2017). We develop a socioeconomic deprivation indicator and rely on a well-accepted indicator of potentially avoidable hospitalizations as a measure of access to CBAC. We estimate socioeconomic gradients at the national and cantonal levels with mixed effects models pooled over four years. We compare gradient estimates among specifications without control variables and those that include control variables for area geography and physician availability. We find that the most deprived area is associated with an excess of 2.80 potentially avoidable hospitalizations per 1,000 population (3.01 with control variables) compared to the least deprived area. We also find significant gradient variation across cantons with a difference of 5.40 (5.54 with control variables) between the smallest and largest canton gradients. Addressing broader social determinants of health, financial barriers to access, and strengthening CBAC services in targeted areas would likely reduce the observed gap.

Potentially Inappropriate Medication Dispensing in Outpatients: Comparison of Different Measurement Approaches.

Purpose of the Research: This paper aims at comparing different approaches to measure potentially inappropriate medication (PIM) with routinely collected data on prescriptions, patient age institutionalization status (ie in nursing home or in the community). A secondary objective is to measure the rate and prevalence of PIM dispensing and to identify problematic practices in Switzerland. Material and Methods: The studied population includes about 90,000 insured over 17 years old from a Swiss health maintenance organization in 2019 and 2020. We computed and compared the number of PIM per patient for Beers criteria, Priscus list, Laroche, NORGEP and Prescrire approaches. We also created a composite indicator that accounts for the specificities of the Swiss context (adaptation to the Swiss drugs' market, recommendations in force related to sleeping pills, anxiolytics and NSAIDs). We also stratified the analysis per physician, including initiation and cessation of PIM prescription. Results: Our comparison revealed similarities between the approaches, but also that each of them had specific gaps that provides further motivation for the development of a composite approach. PIM rate was particularly high for sleeping pills, anxiolytics, NSAIDs, even when analyses were limited to chronic use. Drugs with anticholinergic effect were also frequently prescribed. Based on our composite indicator, 27% of insured over 64 years old received at least one PIM in 2020, and 8% received more than one. Our analyses also reveal that for sleeping pills and anxiolytics, half of the volume (or prevalence?) occurs in the <65 population. We observed strong variations between physicians and a significant proportion of new users among patients with PIM. Conclusion: Our results show that PIMs prescribing is very frequent in Switzerland and is driven mostly by a few drug categories. There is important physician variation in PIM prescribing that warrants the development of intervention targeted at high PIM-prescribers.

[Teaching health equity in the French-speaking part of Switzerland : inventory in 2023]. / Enseignements sur l'équité en santé en Suisse romande : état des lieux en 2023.

The theme of health equity was for a long time absent or little addressed in the pre- and postgraduate teaching programs of universities and training university hospitals in Switzerland. This gap has gradually been filled by the development and provision of structured teaching on health equity, adapted to the needs of their target audiences. This article aims to highlight a selection of teachings that have emerged in recent years in the French-speaking part of Switzerland.

La thématique de l'équité en santé a été pendant longtemps absente ou peu abordée dans les programmes d'enseignement pré et post-gradué des universités et établissements hospitaliers de formation en Suisse. Cette lacune a été progressivement comblée par le développement et la mise à disposition de formations structurées portant sur l'équité en santé, adaptées aux besoins de leurs publics cibles. Cet article vise à mettre en avant une sélection d'enseignements qui ont vu le jour ces dernières années en Suisse romande.

[Understanding health equity through artificial intelligence The case of Agent-Based Modelling (ABM)]. / Comprendre l'équité en santé grâce à l'intelligence artificielle. L'exemple de l'Agent-Based Modelling (ABM).

Agent-Based Modelling (ABM) is a computer modelling technique that simulates the behaviour and interactions of autonomous agents within a virtual environment. Applied to health equity, this technique allows for a better understanding of the complex social and economic determinants that contribute to health inequities and enables the evaluation of the potential effects of public policies on the latter. Despite some limitations related to the accessibility and quality of health data and the complexity of the models, ABM appears to be a promising tool in the field of health equity, both for researchers in public or community health and for policy makers.

L'Agent-Based Modelling (ABM) est une technique de modélisation informatique qui simule le comportement et les interactions d'agents autonomes au sein d'un environnement virtuel. Appliquée à l'équité en santé, cette technique permet de mieux comprendre les déterminants sociaux et économiques complexes qui contribuent aux iniquités de santé et d'évaluer les effets potentiels de politiques publiques sur ces dernières. Malgré quelques limitations liées notamment à l'accessibilité et la qualité des données de santé et la complexité des modèles, l'ABM apparaît comme un outil prometteur dans le domaine de l'équité en santé, tant pour les chercheurs en santé publique et communautaire que pour les décideurs politiques.

Immunosuppressant drugs and quality-of-life outcomes in kidney transplant recipients: An international cohort study (EU-TRAIN).

Introduction: Patient-Reported Outcomes (PRO) integrate a wide range of holistic dimensions that arenot captured within clinical outcomes. Particularly, from induction treatment to maintenance therapy, patient quality-of-life (QoL) of kidney transplant recipients have been sparsely investigated in international settings. Methods: In a prospective, multi-centric cohort study, including nine transplant centers in four countries, we explored the QoL during the year following transplantation using validated elicitation instruments (EQ-5D-3L index with VAS) in a population of kidney transplant patients receiving immunosuppressive therapies. Calcineurin inhibitors (tacrolimus and ciclosporin), IMPD inhibitor (mycophenolate mofetil), and mTOR inhibitors (everolimus and sirolimus) were the standard-of-care (SOC) medications, together with tapering glucocorticoid therapy. We used EQ-5D and VAS data as QoL measures alongside descriptive statistics at inclusion, per country and hospital center. We computed the proportions of patients with different immunosuppressive therapy patterns, and using bivariate and multivariate analyses, assessed the variations of EQ-5D and VAS between baseline (i.e., inclusion Month 0) and follow up visits (Month 12). Results: Among 542 kidney transplant patients included and followed from November 2018 to June 2021, 491 filled at least one QoL questionnaire at least at baseline (Month 0). The majority of patients in all countries received tacrolimus and mycophenolate mofetil, ranging from 90.0% in Switzerland and Spain to 95.8% in Germany. At M12, a significant proportion of patients switched immunosuppressive drugs, with proportion varying from 20% in Germany to 40% in Spain and Switzerland. At visit M12, patients who kept SOC therapy had higher EQ-5D (by 8 percentage points, p < 0.05) and VAS (by 4 percentage points, p < 0.1) scores than switchers. VAS scores were generally lower than EQ-5D (mean 0.68 [0.5-0.8] vs. 0.85 [0.8-1]). Discussion: Although overall a positive trend in QoL was observed, the formal analyses did not show any significant improvements in EQ-5D scores or VAS. Only when the effect of a therapy use was separated from the effect of switching, the VAS score was significantly worse for switchers during the follow up period, irrespective of the therapy type. If adjusted for patient characteristics and medical history (e.g., gender, BMI, eGRF, history of diabetes), VAS and EQ-5D delivered sound PRO measures for QoL assessments during the year following renal transplantation.

The impact of patient safety incidents during hip and knee replacements on patients' health related quality of life: a before and after study using longitudinal data linked to patient-reported outcome measures.

BACKGROUND: The burden of patient safety incidents (PSIs) is often characterized by their impact on mortality, morbidity, and treatment costs. Few studies have attempted to estimate the impact of PSIs on patients' health-related quality of life (HRQoL) and the studies that have made such estimates primarily focus on a narrow set of incidents. The aim of this paper is to estimate the impact of PSIs on HRQoL of patients undergoing elective hip and knee surgery in England. PATIENTS AND METHODS: A unique linked longitudinal data set consisting of patient-reported outcome measures for patients with hip and knee replacements linked to Hospital Episode Statistics (HES) collected between 2013/14 and 2016/17 was examined. Patients with any of nine US Agency for Healthcare Research and Quality (AHRQ) PSI indicators were identified. HRQoL was measured using the general EuroQol five dimensions questionnaire (EQ-5D) before and after surgery. Exploiting the longitudinal structure of the data, exact matching was combined with difference in differences to estimate the impact of experiencing a PSI on HRQoL and its individual dimensions, comparing HRQoL improvements after surgery in similar patients with and without a PSI in a retrospective cohort study. This design compares the change in HRQoL before and after surgery in patients who experience a PSI to those who do not. RESULTS: The sample comprised 190 697 and 204 649 observations for patients undergoing hip replacement and knee replacement respectively. For six out of nine PSIs, patients who experienced a PSI reported improvements in HRQoL that were 14-23% lower than those who did not experience a PSI during surgery. Those who experienced a PSI were also more likely to report worse health states after surgery than those without a PSI on all five dimensions of HRQoL. CONCLUSION: PSIs are associated with a substantial negative impact on patients' HRQoL.

Decision Making About Disease-Modifying Treatments for Relapsing-Remitting Multiple Sclerosis: Stated Preferences and Real-World Choices.

BACKGROUND: People with relapsing-remitting multiple sclerosis can benefit from disease-modifying treatments (DMTs). Several DMTs are available that vary in their efficacy, side-effect profile and mode of administration. OBJECTIVE: We aimed to measure the preferences of people with relapsing-remitting multiple sclerosis for DMTs using a discrete choice experiment and to assess which stated preference attributes correlate with the attributes of the DMTs they take in the real world. METHODS: Discrete choice experiment attributes were developed from literature reviews, interviews and focus groups. In a discrete choice experiment, participants were shown two hypothetical DMTs, then chose whether they preferred one of the DMTs or no treatment. A mixed logit model was estimated from responses and individual-level estimates of participants' preferences conditional on their discrete choice experiment choices calculated. Logit models were estimated with stated preferences predicting current real-world on-treatment status, DMT mode of administration and current DMT. RESULTS: A stated intrinsic preference for taking a DMT was correlated with currently taking a DMT, and stated preferences for mode of administration were correlated with the modes of administration of the DMTs participants were currently taking. Stated preferences for treatment effectiveness and adverse effects were not correlated with real-world behaviour. CONCLUSIONS: There was variation in which discrete choice experiment attributes correlated with participants' real-world DMT choices. This may indicate patient preferences for treatment efficacy/risk are not adequately taken account of in prescribing. Treatment guidelines must ensure they take into consideration patients' preferences and improve communication around treatment efficacy/risk.

Preferences of older adults for healthcare models designed to improve care coordination: Evidence from Western Switzerland.

Implementing innovations in care delivery in Switzerland is challenging due to the fragmented nature of the system and the specificities of the political process (i.e., direct democracy, decentralized decision-making). In this context, it is particularly important to account for population preferences when designing policies. We designed a discrete choice experiment to study population preferences for coordination-improving care models. Specifically, we assessed the relative importance of model characteristics (i.e., insurance premium, presence of care coordinator, access to specialists, use of EMR, cost-sharing for chronic patients, incentives for informal care), and predicted uptake under different policy scenarios. We accounted for heterogeneity in preferences for the status quo option using an error component logit model. Respondents attached the highest importance to the price attribute (i.e. insurance premium) (0.31, CI: 0.27- 0.36) and to the presence of a care coordinator (0.27, CI: 0.23 - 0.31). Policy scenarios showed for instance that gatekeeping would be preferred to free access to specialists if the model includes a GP or an interprofessional team as a care coordinator. Although attachment to the status quo is high in the studied population, there are potential ways to improve acceptance of alternative care models by implementation of positively valued innovations.

Variation in hospital cost trajectories at the end of life by age, multimorbidity and cancer type.

Background: Approximately thirty thousand people in Scotland are diagnosed with cancer annually, of whom a third live less than one year. The timing, nature and value of hospital-based healthcare for patients with advanced cancer are not well understood. The study's aim was to describe the timing and nature of hospital-based healthcare use and associated costs in the last year of life for patients with a cancer diagnosis. Methods: We undertook a Scottish population-wide administrative data linkage study of hospital-based healthcare use for individuals with a cancer diagnosis, who died aged 60 and over between 2012 and 2017. Hospital admissions and length of stay (LOS), as well as the number and nature of outpatient and day case appointments were analysed. Generalised linear models were used to adjust costs for age, gender, socioeconomic deprivation status, rural-urban (RU) status and comorbidity. Results: The study included 85,732 decedents with a cancer diagnosis. For 64,553 (75.3%) of them, cancer was the primary cause of death. Mean age at death was 80.01 (SD 8.15) years. The mean number of inpatient stays in the last year of life was 5.88 (SD 5.68), with a mean LOS of 7 days. Admission rates rose sharply in the last month of life. One year adjusted and unadjusted costs decreased with increasing age. A higher comorbidity burden was associated with higher costs. Major cost differences were present between cancer types. Conclusions: People in Scotland in their last year of life with cancer are high users of secondary care. Hospitalisation accounts for a high proportion of costs, particularly in the last month of life. Further research is needed to examine triggers for hospitalisations and to identify influenceable reasons for unwarranted variation in hospital use among different cancer cohorts.

Stakeholder Engagement in Designing Attributes for a Discrete Choice Experiment With Policy Implications: An Example of 2 Swiss Studies on Healthcare Delivery.

OBJECTIVES: The use of discrete choice experiments (DCEs) has become increasingly popular in health policy development by involving and analyzing the preferences of target groups for different aspects of the policy intervention. In this article, we aim to contribute to the standardization of the process of attribute and attribute level development for DCEs with policy relevance. To do so, we propose and empirically illustrate a framework tool for the development and reporting of attributes and attribute levels, with the systematic engagement of relevant stakeholders. METHODS: The framework tool was kept general to allow its use as a standard reporting approach on the development process of a DCE, involving relevant stakeholders at each stage. The proposed 3-stage process consists of (1) collection, (2) selection, and (3) refinement of the DCE attributes and attribute levels. The application of the framework tool is illustrated by 2 projects, Health2040 and COCONUTS-both concerning the preferences of the Swiss population for the future organization of healthcare. RESULTS: By engaging stakeholders, we identified and included attributes and attribute levels that would not have been identified solely through the existing literature. In addition, including multiple stakeholders from different professional backgrounds ensured that the selected attributes and attribute levels were policy relevant, were applicable in practice, and reflected the opinions of multiple actors in healthcare. CONCLUSION: The proposed framework helps to strengthen the standardization of the reporting on attribute and attribute level development with stakeholder engagement and to guide future research teams designing a DCE with policy implications.

The price of nicotine dependence: A comparison of the cost of nicotine across products in Switzerland, Germany, USA, Sweden, France and the UK, in 2019.

INTRODUCTION: Tobacco cigarette taxes aim at reducing smoking, but smokers are still dependent on nicotine and need safe and cheap alternatives. As the costs play a role in the product chosen, we compared standardized nicotine costs across products and countries. METHODS: We gathered prices of tobacco cigarettes, heated tobacco products (HTP), pharmaceutical nicotine replacement therapy (pNRT) gums, snus, and open and closed electronic nicotine delivery systems (ENDS) in 6 countries (Switzerland, Germany, USA, Sweden, France, UK) in 2019. We compared the cost of a pack of cigarettes in Switzerland to the cost of equivalent doses of nicotine delivered by other products and across countries, normalizing to purchasing power GDP per capita to compute relative adjusted costs (RACs). RESULTS: Adjusted tobacco cigarette cost was lowest in Switzerland, Germany, and Sweden; RAC for pNRT was 1.1 in Switzerland and 1.0 in Germany. In France and the UK, RACs for cigarettes were 1.5 and 2.1, while for pNRT they were cheaper (RAC: 0.04). In Switzerland, snus/nicotine pouches were the cheapest form of nicotine delivery (RAC: 0.2), open ENDS were a low-cost option for nicotine delivery in all countries (RAC: 0.2-0.3), and HTP cost more than regular tobacco products in most countries. CONCLUSIONS: We found broad differences in costs of nicotine according to countries and products. This should be considered in future studies on smoking prevalence and in public health efforts.

Corrigendum: Translating planetary health principles into sustainable primary care services.

[This corrects the article DOI: 10.3389/fpubh.2022.931212.].

Current Expertise, Opinions, and Attitude toward TNF-⍺ Antagonist Biosimilars among Physicians: A Self-Administered Online Survey in Western Switzerland.

Tumor necrosis factor-alpha (TNF-⍺) antagonists are biological drugs with multiple authorized biosimilars. Biosimilars are becoming critical to the financial sustainability of health systems. Recent studies emphasize that physicians' knowledge regarding biosimilars has not yet progressed sufficiently to overcome their concerns regarding biosimilars' safety and efficacy. To assess the current knowledge, opinions, and attitudes toward TNF-⍺ antagonist biosimilars among postgraduate physicians and specialists, an anonymous, self-administered survey was implemented on SurveyMonkey between February and May 2022. The survey was validated through think-aloud interviews with senior and postgraduate physicians in rheumatology, gastroenterology, and immunoallergology, and a senior epidemiologist. Participant recruitment was conducted with the help of the physicians' professional societies and departmental head physicians of two university hospitals in Western Switzerland. Most physicians felt more comfortable initiating a TNF-⍺ antagonist biosimilar in biologic-naive patients (BNPs) than switching patients stabilized on the original biologic (originator). However, most participants agreed that BNPs should start treatment with the biosimilar rather than the originator when available. Postgraduate physicians and specialists in rheumatology, gastroenterology, and immunoallergology who participated in this survey were familiar with TNF-⍺ antagonist biosimilars and were confident in prescribing them. Yet, they still preferred to avoid switching a patient already on the originator.

Combining default choices and an encounter decision aid to improve tobacco cessation in primary care patients: protocol for a cluster-randomized trial.

BACKGROUND: While quitting smoking dramatically decreases overall mortality, general practitioners (GPs) are less likely to prescribe medications for smoking cessation than other cardiovascular risk factors. Guidelines recommend providers first assess patients' "readiness" to quit, an "opt-in" strategy, but only a minority of tobacco users are ready to quit on a given day. An "opt-out" strategy offering treatment as the default choice increased quit attempts in hospital and with pregnant women, but has not been tested in primary care. We will assess the efficacy of training GPs to offer treatment as the default choice using an encounter decision aid with current smokers seen in primary care. METHODS: This is a pragmatic cluster-randomized controlled superiority trial with block randomization at the GP level in private practice in French-speaking Switzerland. GPs will be blinded to the arm allocation. The intervention is a half-day training course teaching an 'opt-out' approach to smoking cessation using an encounter decision aid (paper or electronic). GPs in the enhanced usual care group receives a brief refresher training about smoking cessation without changing their behaviour. GPs in both arms will recruit 23 patients each prior to routine primary care visits. The primary outcome is the effect of consulting a GP who received the intervention on the 7-day, point prevalence, smoking abstinence 6 months after the baseline appointment. Secondary outcomes include continuous abstinence; number of quit attempts; use of smoking cessation aids; patient-perceived involvement in discussions; and changes in GP behaviour. Patient outcomes will be collected using paper and telephone questionnaires. Assuming 15% drop-out, recruiting 46 GPs with 23 patients each will give us 80% power to detect an increase in smoking cessation from 4% (control) to 10.5% (intervention), with an alpha < 0.05. DISCUSSION: GP visits are an opportunity to administer proven smoking cessation treatments. We hypothesize GPs offering smoking cessation treatment as the default choice using an encounter decision aid will increase the number of patients who quit. This study could significantly change our approach to smoking cessation in primary care. Default choices and the electronic decision aid are low-cost, easily diffusible interventions. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04868474, First Posted May 3, 2021, Last Update Posted October 6, 2021.