Development and evaluation of a decision aid for women eligible for organized breast cancer screening according to international standards: A multi-method study.

BACKGROUND: and purpose: In France, women lack information to make a shared decision to start breast cancer screening. Decision aids are useful to facilitate this discussion, yet few meet international standards. The objective of this project was to build, validate and measure the quality of a decision aid for organized breast screening in France, in line with international standards, intended for both women and healthcare professionals. MATERIALS AND METHODS: This mixed-methods study was conducted between January 2017 and June 2022. The prototype was developed from a qualitative study, systematic review and targeted literature review and alpha tested during two Delphi rounds. Readability was evaluated with the Flesch score and content with International Patient Decision Aid Standards Instrument (IPSASi). RESULTS: An online decision aid, accessible at www.Discutons-mammo.fr, written in French was developed. The content included eligibility, information about breast screening the advantages and disadvantages of screening, patient preferences and a patient-based discussion guide using text, infographics, and videos. The Flesch readability test score was 65.4 and the IPDASi construct quality score was 176 out of 188. CONCLUSIONS: This decision aid complies with IPDASi standards and could help women eligible for breast screening in France make a shared decision with a specialized healthcare professional about whether or not to participate in organized breast screening.

Breast cancer: a randomized controlled trial assessing the effect of a decision aid on mammography screening uptake: study protocol.

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.

Implementation of shared decision-making and patient-centered care in France: Towards a wider uptake in 2022.

We present the evolution of patient-centered care (PCC) and shared decision-making (SDM) in France since 2017, highlighting advantages and drawbacks of their implementation at the macro level. We then focus on several key policy and legislative milestones that are aimed to develop PCC and SDM. These milestones underline the importance of patient movements to support and fund the development of research and practice in the field. We shall conclude by presenting the growing research agenda and selected key topics. These key topics notably include the increase in both patient and healthcare professional trainings on PCC and SDM provided by healthcare users' and patients' representatives. PCC and SDM continue to be central preoccupations at the macro level, supported by public health policies and patients/healthcare users' actions. This overview, however, suggests that although implementation initiatives have increased since 2017, implementation remains scarce in routine clinical practice. Funding, not only for research projects, but for the implementation of PCC and SDM in real-life settings (e-decision aids, clinical guidelines integrating PCC/SDM, human resources dedicated to PCC/SDM, etc.) are needed to promote sustained adoption. More systematic training for both healthcare professionals and patients is also warranted for a true acculturation to occur.

Patient-safety incidents during COVID-19 health crisis in France: An exploratory sequential multi-method study in primary care.

BACKGROUND: The COVID-19 pandemic has resulted in the rapid reorganisation of health and social care services. Patients are already at significant risk of healthcare-associated harm and the wholesale disruption to service delivery during the pandemic stood to heighten those risks. OBJECTIVES: We explored the type and nature of patient safety incidents in French primary care settings during the COVID-19 first wave to make tentative recommendations for improvement. METHODS: A national patient safety incident reporting survey was distributed to General Practitioners (GPs) in France on 28 April 2020. Reports were coded using a classification system aligned to the WHO International Classification for Patient Safety (incident types, contributing factors, incident outcomes and severity of harm). Analysis involved data coding, processing, iterative generation of data summaries using descriptive statistical analysis. Clinicaltrials.gov: NCT04346121. RESULTS: Of 132 incidents, 58 (44%) related to delayed diagnosis, assessments and referrals. Cancellations of appointments, hospitalisations or procedures was reported in 22 (17%) of these incidents. Home confinement-related incidents accounted for 13 (10%) reports and inappropriate medication stopping for five (4%). Patients delayed attending or did not consult their general practitioner or other healthcare providers due to their fear of contracting COVID-19 infection at an in-person visit in 26 (10%) incidents or fear of burdening their GPs in eight (3%) incidents. CONCLUSION: Constraints from the first wave of the COVID-19 pandemic have contributed to patient safety incidents during non-COVID-19 care. Lessons from these incidents pinpoint where primary care services in France can focus resources to design safer systems for patients.

Quality of decision aids developed for women at average risk of breast cancer eligible for mammographic screening: Systematic review and assessment according to the International Patient Decision Aid Standards instrument.

Mammographic screening contributes to a reduction in specific mortality, but it has disadvantages. Decision aids are tools designed to support people's decisions. Because these aids influence patient choice, their quality is crucial. The objective of the current study was to conduct a systematic review of decision aids developed for women eligible for mammographic screening who have an average breast cancer risk and to assess the quality of these aids. The systematic review included articles published between January 1, 1997, and August 1, 2019, in the PubMed, Embase, Cochrane, and PsycInfo databases. The studies were reviewed independently by 2 reviewers. Any study containing a decision aid for women eligible for mammographic screening with an average breast cancer risk was included. Two double-blind reviewers assessed the quality of the selected decision aids using the International Patient Decision Aid Standards instrument, version 3 (IPDASi). Twenty-three decision aids were extracted. Classification of decision aid quality using the IPDASi demonstrated large variations among the decision aids (maximum IPDASi score, 188; mean ± SD score, 132.6 ± 23.8; range, 85-172). Three decision aids had high overall scores. The 3 best-rated dimensions were disclosure (maximum score, 8; mean score, 6.8), focusing on transparency; information (maximum score, 32; mean score, 26.1), focusing on the provision of sufficient details; and probabilities (maximum score, 32; mean score 25), focusing on the presentation of probabilities. The 3 lowest-rated dimensions were decision support technology evaluation (maximum score, 8; mean score, 4.3), focusing on the effectiveness of the decision aid; development (maximum score, 24; mean score, 12.6), evaluating the development process; and plain language (maximum score, 4; mean score, 1.9), assessing appropriateness for patients with low literacy. The results of this review identified 3 high-quality decision aids for breast cancer screening.

Use of Smartphones for Early Detection of Melanoma: Systematic Review.

BACKGROUND: The early diagnosis of melanoma is associated with decreased mortality. The smartphone, with its apps and the possibility of sending photographs to a dermatologist, could improve the early diagnosis of melanoma. OBJECTIVE: The aim of our review was to report the evidence on (1) the diagnostic performance of automated smartphone apps and store-and-forward teledermatology via a smartphone in the early detection of melanoma, (2) the impact on the patient's medical-care course, and (3) the feasibility criteria (focusing on the modalities of picture taking, transfer of data, and time to get a reply). METHODS: We conducted a systematic search of PubMed for the period from January 1, 2007 (launch of the first smartphone) to November 1, 2017. RESULTS: The results of the 25 studies included 13 concentrated on store-and-forward teledermatology, and 12 analyzed automated smartphone apps. Store-and-forward teledermatology opens several new perspectives, such as it accelerates the care course (less than 10 days vs 80 days), and the related procedures were assessed in primary care populations. However, the concordance between the conclusion of a teledermatologist and the conclusion of a dermatologist who conducts a face-to-face examination depended on the study (the kappa coefficient range was .20 to .84, median κ=.60). The use of a dermoscope may improve the concordance (the kappa coefficient range was .29 to .87, median κ=.74). Regarding automated smartphone apps, the major concerns are the lack of assessment in clinical practice conditions, the lack of assessment in primary care populations, and their low sensitivity, ranging from 7% to 87% (median 69%). In this literature review, up to 20% of the photographs transmitted were of insufficient quality. The modalities of picture taking and encryption of the data were only partially reported. CONCLUSIONS: The use of store-and-forward teledermatology could improve access to a dermatology consultation by optimizing the care course. Our review confirmed the absence of evidence of the safety and efficacy of automated smartphone medical apps. Further research is required to determine quality criteria, as there was major variability among the studies.

Anxiety, locus of control and sociodemographic factors associated with adherence to an annual clinical skin monitoring: a cross-sectional survey among 1000 high-risk French patients involved in a pilot-targeted screening programme for melanoma.

OBJECTIVE: The aim of the study was to assess whether adherence to annual clinical skin monitoring is dependent on patient sociodemographic characteristics or personality traits. DESIGN: The study was a questionnaire survey. SETTING AND PARTICIPANTS: Data were collected between February and April 2013 in a sample of 1000 patients at high risk of melanoma who participated in a pilot-targeted screening programme in western France. OUTCOME MEASURES: Sociodemographic data, overall anxiety level (State-Trait Anxiety Inventory questionnaire), locus of control (Multidimensional Health Locus of Control scale) and levels of anxiety specifically associated with screening and melanoma were collected. Actual participation in the skin monitoring examination was reported by 78 general practitioner investigators. STATISTICAL ANALYSIS: Statistical analysis was performed using R statistical software. Factors associated with non-adherence were identified by multivariate analysis. RESULTS: Our analysis included 687 responses (526 adherent patients and 161 non-adherent patients). Non-adherence was higher in younger patients and in men (OR=0.63 (0.41-0.99)). Viewing health status as dependent on external persons (OR=0.90, 95% CI 0.83 to 0.97) or determined by chance (OR=0.89, 95% CI 0.80 to 0.98) and overall anxiety (OR=0.98, 95% CI 0.97 to 0.99) were also factors associated with non-adherence. In contrast, there was no link between anxiety specifically associated with the screening performed or melanoma and patient adherence to monitoring. Adherence was higher in married patients (OR=1.68 95% CI 1.08 to 2.60). CONCLUSIONS: The results of this study suggest that sociodemographic and psychological characteristics should be considered when including patients at elevated risk of melanoma in a targeted screening programme. TRIAL REGISTRATION NUMBER: NCT01610531; Post-results.