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Introduction: Breast cancer (BC) is the primary cancer among women. The World Health Organization recommends a bilateral screening mammogram every 2 years for women aged 50 to 74 years. However, it has been shown that there is an absence of information about the benefits and risks of screening. Shared medical decision-making is important to ensure patients are involved in the decision process. Decision aids can facilitative this decision-making process. This article presents a protocol to evaluate the effect of a decision aid on participation rates in the French organized BC screening program. Methods and analysis: Design and setting. The design is a 2 arm randomized controlled study, performed in the Pays de la Loire region (French West Coast). Randomization will be based on general medicine practices (Primary Care). Participants: Women aged between 50 and 74 years, eligible for BC screening. In this region, there are 75000 women, and 2800 general practitioners eligible for recruitment. Intervention: In the « Decision aid for organized cancer screening ¼ arm, the intervention will distribute invitation letters to eligible women combined with the provision of decision aid to these women and their general practitioners and an incentive to implement shared medical decision-making. In the « Standard organized cancer screening ¼ arm, only the screening invitation will be sent to eligible women. Primary endpoint: BC screening participation rates will be assessed after an 18-month follow-up period. Statistical analysis: In this non-inferiority trial, the percentage of women who are up-to-date with their screening at 18 months after the intervention will be compared across arms using a generalized mixed linear model. Discussion: The research team expect to demonstrate that providing a better explanation of the benefits and risks of BC screening is not at odds with screening participation. The study results should help policy makers thinking about implementing shared medical decision-making within the framework of organized BC screening programs in the future. Ethics and dissemination: On 6 December 2021, the protocol received a favorable opinion from the French Committee for the Protection of Persons (2021-A01583-38). This study is registered with ClinicalTrials.gov, number NCT05607849. (Version 1, November 7, 2022; https://www.clinicaltrials.gov/ct2/show/NCT05607849). The study findings will be used for publication in peer-reviewed scientific journals and presentations in scientific meetings.
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BACKGROUND: International guidelines recommend avoiding prostate-specific antigen (PSA)-based prostate cancer screening in the elderly when life expectancy is less than 10 years. For younger men, most recommendations encourage a shared decision-making process taking into account patient comorbidities. OBJECTIVE: The objective was to assess the performance of PSA-based prostate cancer screening in men older than 74 years and assess whether the presence (vs absence) of comorbidities was related to the performance of PSA testing in younger men aged 50 to 74 years who were eligible for screening. METHODS: We analyzed data from the French national health care database (Loire-Atlantique geographic area). We reported the follow-up of two cohorts of men from April 1, 2014, to March 31, 2016: 22,480 men aged over 74 years and 98,107 men aged 50 to 74 years. We analyzed whether these patients underwent PSA testing after 2 years of follow-up and whether PSA testing performance was related to the following patient-related variables: age, low income, proxy measures indicative of major comorbidities (repeated ambulance transportation, having one of 30 chronic diseases, taking 5 or more drugs per day), or proxy measures indicative of specific comorbidities (cancer diseases, cardiovascular diseases, or psychiatric disorders). Statistical analysis was based on a multivariate mixed-effects logistic regression. RESULTS: The proportion of patients who underwent a PSA-based screening test was 41.35% (9296/22,480) among men older than 74 years versus 41.05% (40,275/98,107) among men aged 50 to 74 years. The following factors were associated with less frequent PSA testing in men older than 74 years-age (odds ratio [OR] 0.89, 95% CI 0.88-0.89), low income (OR 0.18, 95% CI 0.05-0.69), suffering from a chronic disease (OR 0.82, 95% CI 0.76-0.88), repeated ambulance transportation (OR 0.37, 95% CI 0.31-0.44), diabetes requiring insulin (OR 0.51, 95% CI 0.43-0.60), dementia (OR 0.68, 95% CI 0.55-0.84), and antipsychotic treatment (OR 0.62, 95% CI 0.51-0.75)-whereas cardiovascular drug treatment was associated with more frequent PSA testing (OR 1.6, 95% CI 1.53-1.84). The following factors were associated with less frequent PSA testing in men aged 50 to 74 years-low income (OR 0.61, 95% CI 0.55-0.68); nonspecific conditions related to frailty: suffering from a chronic disease (OR 0.80, 95% CI 0.76-0.83), repeated ambulance transportation (OR 0.29, 95% CI 0.23-0.38), or chronic treatment with 5 or more drugs (OR 0.89, 95% CI 0.83-0.96); and various specific comorbidities: anticancer drug treatment (OR 0.67, 95% CI 0.55-0.83), diabetes requiring insulin (OR 0.55, 95% CI 0.49-0.61), and antiaggregant treatment (OR 0.91, 95% CI 0.86-0.96)-whereas older age (OR 1.07, 95% CI 1.07-1.08) and treatment with other cardiovascular drugs (OR 2.23, 95% CI 2.15-2.32) were associated with more frequent PSA testing. CONCLUSIONS: In this study, 41.35% (9296/22,480) of French men older than 74 years had a PSA-based screening test. Although it depends on patient comorbidities, PSA testing remains inappropriate in certain populations.
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Importance: Increasing participation in fecal screening tests is a major challenge in countries that have implemented colorectal cancer (CRC) screening programs. Objective: To determine whether providing general practitioners (GPs) a list of patients who are nonadherent to CRC screening enhances patient participation in fecal immunochemical testing (FIT). Design, Setting, and Participants: A 3-group, cluster-randomized study was conducted from July 14, 2015, to July 14, 2016, on the west coast of France, with GPs in 801 practices participating and involving adult patients (50-74 years) who were at average risk of CRC and not up-to-date with CRC screening. The final follow-up date was July 14, 2016. Interventions: General practitioners were randomly assigned to 1 of 3 groups: 496 received a list of patients who had not undergone CRC screening (patient-specific reminders group, 10â¯476 patients), 495 received a letter describing region-specific CRC screening adherence rates (generic reminders group, 10â¯606 patients), and 455 did not receive any reminders (usual care group, 10â¯147 patients). Main Outcomes and Measures: The primary end point was patient participation in CRC screening 1 year after the intervention. Results: Among 1482 randomized GPs (mean age, 53.4 years; 576 women [38.9%]), 1446 participated; of the 33â¯044 patients of these GPs (mean age, 59.7 years; 17â¯949 women [54.3%]), follow-up at 1 year was available for 31â¯229 (94.5%). At 1 year, 24.8% (95% CI, 23.4%-26.2%) of patients in the specific reminders group, 21.7% (95% CI, 20.5%-22.8%) in the generic reminders group, and 20.6% (95% CI, 19.3%-21.8%) in the usual care group participated in the FIT screening. The between-group differences were 3.1% (95% CI, 1.3%-5.0%) for the patient-specific reminders group vs the generic reminders group, 4.2% (95% CI, 2.3%-6.2%) for the patient-specific reminders group vs the usual care group, and 1.1% (95% CI, -0.6% to 2.8%) for generic reminders group vs the usual care group. Conclusions and Relevance: Providing French GPs caring for adults at average risk of CRC with a list of their patients who were not up-to-date with their CRC screening resulted in a small but significant increase in patient participation in FIT screening at 1 year compared with patients who received usual care. Providing GPs with generic reminders about regional rates of CRC screening did not increase screening rates compared with usual care. Trial Registration: clinicaltrials.gov Identifier: NCT02515344.