Increasing access to fertility preservation for women with breast cancer: protocol for a stepped-wedge cluster randomized trial in France.

BACKGROUND: With the increase in the number of long-term survivors, interest is shifting from cancer survival to life and quality of life after cancer. These include consequences of long-term side effects of treatment, such as gonadotoxicity. Fertility preservation is becoming increasingly important in cancer management. International recommendations agree on the need to inform patients prior to treatments about the risk of fertility impairment and refer them to specialized centers to discuss fertility preservation. However, the literature reveals suboptimal access to fertility preservation on an international scale, and particularly in France, making information for patients and oncologists a potential lever for action. Our overall goal is to improve access to fertility preservation consultations for women with breast cancer through the development and evaluation of a combined intervention targeting the access and diffusion of information for these patients and brief training for oncologists. METHODS: Firstly, we will improve existing information tools and create brief training content for oncologists using a qualitative, iterative, user-centred and participatory approach (objective 1). We will then use these tools in a combined intervention to conduct a stepped-wedge cluster randomized trial (objective 2) including 750 women aged 18 to 40 newly treated with chemotherapy for breast cancer at one of the 6 participating centers. As the primary outcome of the trial will be the access to fertility preservation counselling before and after using the combined intervention (brochures and brief training for oncologists), we will compare the rate of fertility preservation consultations between the usual care and intervention phases using linear regression models. Finally, we will analyse our approach using a context-sensitive implementation analysis and provide key elements for transferability to other contexts in France (objective 3). DISCUSSION: We expect to observe an increase in access to fertility preservation consultations as a result of the combined intervention. Particular attention will be paid to the effect of this intervention on socially disadvantaged women, who are known to be at greater risk of inappropriate treatment. The user-centred design principles and participatory approaches used to optimize the acceptability, usability and feasibility of the combined intervention will likely enhance its impact, diffusion and sustainability. TRIAL REGISTRATION: Registry: ClinicalTrials.gov. TRIAL REGISTRATION NUMBER: NCT05989776. Date of registration: 7th September 2023. URL: https://classic. CLINICALTRIALS: gov/ct2/show/NCT05989776 . PROTOCOL VERSION: Manuscript based on study protocol version 2.0, 21st may 2023.

Evaluation of the Tuto'Tour pregnancy intervention among pregnant smokers in vulnerable situations / Évaluation du dispositif Tuto'Tour de la grossesse chez les femmes fumeuses enceintes vulnérables.

INTRODUCTION: In France, pregnant women generally receive written information about their pregnancy. The efficacy of these materials is limited for socially disadvantaged women, who are more likely to have lower levels of health literacy. As an alternative tool, awareness-raising videos have become popular, and the "Tuto'Tour de la grossesse" health promotion intervention has been created, which includes videos about smoking. The study objective was to evaluate the acceptability, usability, and accessibility of two videos about smoking among pregnant smokers in vulnerable situations. METHODS: We conducted semi-structured interviews with these women, using a participatory approach. We then carried out a hybrid qualitative analysis, combining an analysis based on a conceptual framework and an inductive analysis. RESULTS: Out of twenty participants, nine were separated from their child's father and nine were unemployed. Twelve participants had less than a baccalaureate level of education and seven had a mother tongue other than French. Participants found the videos acceptable, usable, and accessible. We received positive feedback about the efficacy of the videos in terms of participants' ability, opportunity, and motivation to change their behavior. Suggestions for improving the videos were made. CONCLUSIONS: Other studies have looked at health promotion with similar interventions, but acceptability, usability, and accessibility have not been tested with socially disadvantaged women. These videos, which are acceptable, usable, and accessible to socially disadvantaged people, seem to have an influence on two out of three factors leading to behavior change. They could now be tested on a larger scale in a randomized controlled study.

Introduction: En France, les femmes enceintes reçoivent généralement des informations concernant leur grossesse sous forme écrite. Ces supports présentent des limites pour les femmes en situation de vulnérabilité, à plus haut risque d'avoir une littératie en santé limitée. Ainsi, les vidéos de sensibilisation sont devenues populaires et le dispositif de promotion de santé « Tuto'Tour de la grossesse ¼ a été créé, comprenant des vidéos sur le tabac. L'objectif de notre étude était d'évaluer l'acceptabilité, l'utilisabilité et l'accessibilité de deux vidéos sur le tabagisme chez les femmes enceintes fumeuses en situation de vulnérabilité. Méthodes: Nous avons conduit des entretiens semi-directifs auprès de ces femmes, en suivant une approche participative. Nous avons ensuite procédé à une analyse qualitative hybride, combinant une analyse fondée sur une trame conceptuelle et une analyse inductive. Résultats: Sur vingt participantes, neuf étaient séparées du père de l'enfant et neuf étaient sans emploi. Douze d'entre elles n'avaient pas atteint un niveau de formation équivalent au baccalauréat et sept avaient une langue maternelle autre que le français. Les vidéos ont été jugées acceptables, utilisables et accessibles pour les participantes. Des retours positifs ont été recueillis concernant l'efficacité des vidéos à induire un changement de comportement. Des pistes pour améliorer les vidéos ont été suggérées. Conclusions: D'autres études s'intéressent à des dispositifs similaires mais l'acceptabilité, l'utilisabilité et l'accessibilité n'ont pas été testées. Ces vidéos semblent avoir une influence sur deux des trois facteurs menant à un changement de comportement. Elles peuvent maintenant être testées à plus grande échelle dans une étude contrôlée randomisée.

[Patient decision aids for cancer prevention Synthesis for the francophone community]. / Outils d'aide à la décision pour la prévention des cancers. Synthèse pour la francophonie.

In recent years, the relationship between patients and healthcare professionals, and more broadly between public health actors and citizens, has shifted from a paternalistic, top-down approach to one of increased patient involvement in decision-making. Primary and secondary cancer prevention involve both benefits and risks, underscoring the importance of informed decision-making aligned with each patient and citizen's unique values and preferences. Shared decision-making, supported by decision aids, offers patients and citizens clear and comprehensible information about their options, enabling informed choices. This article aims to compile and define the characteristics of tools developed or translated into French for this purpose.

Depuis plusieurs années, la relation entre les patients et les professionnels de la santé et plus largement entre les acteurs de la santé publique et les citoyens a évolué, passant d'une approche paternaliste et top-down à une implication accrue des patients dans les décisions les concernant. La prévention primaire et secondaire des cancers présente des bénéfices mais parfois également des risques, nécessitant une décision alignée avec les valeurs et les préférences des patients et des citoyens. La prise de décision partagée, via des outils d'aide à la décision, offre aux patients des informations claires et faciles à comprendre à propos des options qui leur sont offertes, afin de prendre une décision éclairée. Cet article vise à recenser les outils créés ou traduits en français et à en définir les caractéristiques.

The Costs of Implementing a Conversation Aid for Uterine Fibroids in Multiple Health Care Settings.

BACKGROUND: Health care organizations considering adopting a conversation aid (CA), a type of patient decision aid innovation, need information about the costs of implementation. OBJECTIVES: The aims of this study were to: (1) calculate the costs of introducing a CA in a study of supported implementation in 5 gynecologic settings that manage individuals diagnosed with uterine fibroids and (2) estimate the potential costs of future clinical implementation efforts in hypothetical settings. RESEARCH DESIGN: We used time-driven activity-based costing to estimate the costs of CA implementation at multiple steps: integration with an electronic health record, preimplementation, implementation, and sustainability. We then estimated costs for 2 disparate hypothetical implementation scenarios. SUBJECTS AND DATA COLLECTION: We conducted semistructured interviews with participants and examined internal documentation. RESULTS: We interviewed 41 individuals, analyzed 51 documents and 100 emails. Overall total implementation costs over ∼36 months of activities varied significantly across the 5 settings, ranging from $14,157 to $69,134. Factors influencing costs included size/complexity of the setting, urban/rural location, practice culture, and capacity to automate patient identification. Initial investments were substantial, comprising mostly personnel time. Settings that embedded CA use into standard workflows and automated identification of appropriate patients had the lowest initial investment and sustainability costs. Our estimates of the costs of sustaining implementation were much lower than initial investments and mostly attributable to CA subscription fees. CONCLUSION: Initiation and implementation of the interventions require significant personnel effort. Ongoing costs to maintain use are much lower and are a small fraction of overall organizational operating costs.

The impact of adding cost information to a conversation aid to support shared decision making about low-risk prostate cancer treatment: Results of a stepped-wedge cluster randomised trial.

BACKGROUND: Decision aids help patients consider the benefits and drawbacks of care options but rarely include cost information. We assessed the impact of a conversation-based decision aid containing information about low-risk prostate cancer management options and their relative costs. METHODS: We conducted a stepped-wedge cluster randomised trial in outpatient urology practices within a US-based academic medical center. We randomised five clinicians to four intervention sequences and enroled patients newly diagnosed with low-risk prostate cancer. Primary patient-reported outcomes collected postvisit included the frequency of cost conversations and referrals to address costs. Other patient-reported outcomes included: decisional conflict postvisit and at 3 months, decision regret at 3 months, shared decision-making postvisit, financial toxicity postvisit and at 3 months. Clinicians reported their attitudes about shared decision-making pre- and poststudy, and the intervention's feasibility and acceptability. We used hierarchical regression analysis to assess patient outcomes. The clinician was included as a random effect; fixed effects included education, employment, telehealth versus in-person visit, visit date, and enrolment period. RESULTS: Between April 2020 and March 2022, we screened 513 patients, contacted 217 eligible patients, and enroled 117/217 (54%) (51 in usual care, 66 in the intervention group). In adjusted analyses, the intervention was not associated with cost conversations (ß = .82, p = .27), referrals to cost-related resources (ß = -0.36, p = .81), shared decision-making (ß = -0.79, p = .32), decisional conflict postvisit (ß = -0.34, p= .70), or at follow-up (ß = -2.19, p = .16), decision regret at follow-up (ß = -9.76, p = .11), or financial toxicity postvisit (ß = -1.32, p = .63) or at follow-up (ß = -2.41, p = .23). Most clinicians and patients had positive attitudes about the intervention and shared decision-making. In exploratory unadjusted analyses, patients in the intervention group experienced more transient indecision (p < .02) suggesting increased deliberation between visit and follow-up. DISCUSSION: Despite enthusiasm from clinicians, the intervention was not significantly associated with hypothesised outcomes, though we were unable to robustly test outcomes due to recruitment challenges. Recruitment at the start of the COVID-19 pandemic impacted eligibility, sample size/power, study procedures, and increased telehealth visits and financial worry, independent of the intervention. Future work should explore ways to support shared decision-making, cost conversations, and choice deliberation with a larger sample. Such work could involve additional members of the care team, and consider the detail, quality, and timing of addressing these issues. PATIENT OR PUBLIC CONTRIBUTION: Patients and clinicians were engaged as stakeholder advisors meeting monthly throughout the duration of the project to advise on the study design, measures selected, data interpretation, and dissemination of study findings.

The CONFIDENT study protocol: a randomized controlled trial comparing two methods to increase long-term care worker confidence in the COVID-19 vaccines.

BACKGROUND: Clinical and real-world effectiveness data for the COVID-19 vaccines have shown that they are the best defense in preventing severe illness and death throughout the pandemic. However, in the US, some groups remain more hesitant than others about receiving COVID-19 vaccines. One important group is long-term care workers (LTCWs), especially because they risk infecting the vulnerable and clinically complex populations they serve. There is a lack of research about how best to increase vaccine confidence, especially in frontline LTCWs and healthcare staff. Our aims are to: (1) compare the impact of two interventions delivered online to enhanced usual practice on LTCW COVID-19 vaccine confidence and other pre-specified secondary outcomes, (2) determine if LTCWs' characteristics and other factors mediate and moderate the interventions' effect on study outcomes, and (3) explore the implementation characteristics, contexts, and processes needed to sustain a wider use of the interventions. METHODS: We will conduct a three-arm randomized controlled effectiveness-implementation hybrid (type 2) trial, with randomization at the participant level. Arm 1 is a dialogue-based webinar intervention facilitated by a LTCW and a medical expert and guided by an evidence-based COVID-19 vaccine decision tool. Arm 2 is a curated social media web application intervention featuring interactive, dynamic content about COVID-19 and relevant vaccines. Arm 3 is enhanced usual practice, which directs participants to online public health information about COVID-19 vaccines. Participants will be recruited via online posts and advertisements, email invitations, and in-person visits to care settings. Trial data will be collected at four time points using online surveys. The primary outcome is COVID-19 vaccine confidence. Secondary outcomes include vaccine uptake, vaccine and booster intent for those unvaccinated, likelihood of recommending vaccination (both initial series and booster), feeling informed about the vaccines, identification of vaccine information and misinformation, and trust in COVID-19 vaccine information provided by different people and organizations. Exploration of intervention implementation will involve interviews with study participants and other stakeholders, an in-depth process evaluation, and testing during a subsequent sustainability phase. DISCUSSION: Study findings will contribute new knowledge about how to increase COVID-19 vaccine confidence and effective informational modalities for LTCWs. TRIAL REGISTRATION: NCT05168800 at ClinicalTrials.gov, registered December 23, 2021.

Acceptability of interventional materials: public participation in public health interventional research / Acceptabilité d'une intervention : exemple de participation des publics en recherche interventionnelle en santé publique

Introduction: The uptake rate of colorectal cancer screening remains insufficient in France and decreases as the level of deprivation increases. Participants' health literacy appears to be an important determinant of screening uptake. Aim of the study: The aim of this study, nested in our multicenter-randomized controlled trial, was to present the development and acceptability of interventional material (training and a pictorial brochure) for general practitioners and healthcare users in disadvantaged geographical areas using a participatory involvement approach. Methods: The development of the brochure and the training was carried out in three stages, two for the development, usability, and acceptability testing and a third for its evaluation with the target audience. We used a qualitative approach based on focus groups and cognitive interviews. The qualitative analysis was based on Morville's "Honeycomb" conceptual model and the COREQ checklist. Results: The development and test of the acceptability of the material enabled us to adjust the content of the training by proposing examples that were more rooted in professional reality, and to produce a brochure that was easy to read, understand, acceptable and adapted to the intervention's targeted audience. Conclusions: This experience illustrates in a concrete way the feasibility of public participation and its value in the context of interventional research, and more generally in the creation of interventional material.

Introduction: Le taux de participation au dépistage du cancer colorectal reste insuffisant en France et diminue à mesure que le niveau de précarité augmente. La littératie en santé est un déterminant important du recours au dépistage. But de l'étude: Cette étude, nichée dans notre essai randomisé multicentrique, a pour but de présenter la procédure d'élaboration (procédé itératif de test d'utilisabilité et d'acceptabilité) et de vérification de l'acceptabilité de l'intervention (formation et brochure imagée) ciblant les médecins généralistes et usagers du soin dans des zones géographiques défavorisées, selon une approche participative. Méthodes: Le développement de la brochure et de la formation a été réalisé en trois étapes : deux pour l'élaboration et tests itératifs d'utilisabilité et acceptabilité et une troisième pour vérifier l'acceptabilité auprès des publics cibles. Nous avons utilisé une approche qualitative par focus group et entretiens individuels cognitifs dont l'analyse repose sur le « nid d'abeille ¼ de Morville et la grille COREQ. Résultats: Le développement itératif et la vérification de l'acceptabilité du matériel nous ont permis, d'une part, de réaliser des ajustements quant au contenu de la formation, en proposant des exemples plus ancrés dans la réalité professionnelle et, d'autre part, de produire une brochure imagée facile à lire et à comprendre, acceptable et adaptée au public ciblé par l'intervention. Conclusions: Cette expérience illustre, de manière concrète, la faisabilité de cette modalité de participation des publics concernés et son intérêt dans le cadre de la recherche interventionnelle et, plus généralement, dans le matériel interventionnel.

[Can we increase the availability of decision aids in French-speaking Switzerland?] / Comment augmenter l'accès aux outils d'aide à la décision en Suisse romande ?

Models of shared decision making recommend the use of patient decision aids. Hundreds of such aids exist worldwide but scaling up of their use in French-speaking Switzerland requires their translation to French and their adaptation to the clinical context. We review seven sources of tools that we assume relevant for French-speaking Switzerland. A short survey on a selection of three decision aids of general practitioners in the canton of Vaud confirmed their general interest in using such tools. They preferred a limited amount and a simple presentation of information in the decision aids to facilitate integration in clinical practice. Given the complexity of the required translations and adaptations, the medical community should develop a collaborative approach to lift this important task.

Les modèles de décision partagée recommandent, autant que possible, l'utilisation d'outils d'aide à la décision. La mise à l'échelle de la décision partagée en Suisse romande nécessite l'accès à un grand nombre d'outils de qualité disponibles en français et adaptés à notre pratique. Des centaines d'outils existent dans le monde entier. Nous passons en revue 7 types d'outils que nous supposons pertinents pour leur utilisation en Suisse romande. Nous présentons également l'avis d'un échantillon de convenance de 10 médecins généralistes vaudois sur une sélection de 3 outils. Les médecins étaient intéressés par l'utilisation de ces outils. Ils jugeaient qu'une quantité limitée et une présentation simplifiée des informations s'intégreraient mieux à leur pratique. La question de leur traduction et/ou adaptation éventuelle demeure complexe.

A Rectal Cancer Surgical Decision Aid Is Not Enough: A Qualitative Study.

BACKGROUND: Rectal cancer patients often face complex surgical treatment decisions, but there are few available tools to aid in decision-making. OBJECTIVE: We aimed to identify content and delivery preferences of rectal cancer patients and colorectal surgeons to guide future surgical decision aid creation. DESIGN: Qualitative study: inductive thematic analysis of semi-structured interviews. SETTING: In-person and phone interviews. PATIENTS: We purposively sampled 15 rectal cancer survivors based on demographics and surgery type. Five caregivers also participated. We purposively selected 10 surgeons based on practice type and years of experience. INTERVENTIONS: Semi-structured interviews. MAIN OUTCOME MEASURES: Major and minor themes for survivors and surgeons with thematic saturation. RESULTS: Interviews were a median of 61 minutes (41-93) for patients and 35 minutes (25-59) for surgeons. Nine survivors were younger than 65 years; 7 were female. Surgeons had been practicing for a mean of 10 years (SD 7.4), with 7 in academic and 3 in private settings. Participating survivors and surgeons wanted a comprehensive educational tool-not just a surgical decision aid. Survivors wanted more information on rectal cancer basics and lifestyle, care timelines, and resources during treatment. Surgeons thought patients mostly desired information about surgical options and bowel function. Both patients and surgeons wanted a tool that was personalized, simple, understandable, visually appealing, interactive, short, and in multiple formats. LIMITATIONS: Results may not be generalizable due to selection bias of participants. CONCLUSION: Rectal cancer survivors, their caregivers, and colorectal surgeons wanted an educational support tool that would address substantial educational needs through the continuum of disease rather than a surgical decision aid focusing on a discrete surgical choice only. See Video Abstract at http://links.lww.com/DCR/C20 . UNA AYUDA PARA LA DECISIN QUIRRGICA DEL CNCER DE RECTO NO ES SUFICIENTE UN ESTUDIO CUALITATIVO: ANTECEDENTES:Los pacientes con cáncer de recto a menudo enfrentan decisiones de tratamiento quirúrgico complejas, pero hay pocas herramientas disponibles para ayudar en la toma de decisiones.OBJETIVO:Nuestro objetivo fue identificar el contenido y las preferencias de entrega de los pacientes con cáncer de recto y los cirujanos colorrectales para guiar la futura creación de ayuda para la toma de decisiones quirúrgicas.DISEÑO:Estudio cualitativo: análisis temático inductivo de entrevistas semiestructuradas.ESCENARIO:Entrevistas en persona y por teléfono.PACIENTES:Tomamos muestras intencionalmente de 15 sobrevivientes de cáncer de recto, según la demografía y el tipo de cirugía. También participaron cinco cuidadores. Seleccionamos intencionalmente a 10 cirujanos según el tipo de práctica y los años de experiencia.INTERVENCIONES:Entrevistas semiestructuradas.PRINCIPALES MEDIDAS DE RESULTADO:Temas principales y secundarios para sobrevivientes y cirujanos con saturación temática.RESULTADOS:Las entrevistas tuvieron una mediana de 61 minutos (41-93) para pacientes y 35 minutos (25-59) para cirujanos. Nueve sobrevivientes tenían menos de 65 años; siete eran mujeres. Los cirujanos habían estado ejerciendo una media de 10 años (DE 7,4), con siete en entornos académicos y 3 en entornos privados. Los sobrevivientes y cirujanos participantes querían una herramienta educativa comprensible, no solo una ayuda para la decisión quirúrgica. Los sobrevivientes querían más información sobre los conceptos básicos y el estilo de vida del cáncer de recto, los plazos de atención y los recursos durante el tratamiento. Los cirujanos pensaron que los pacientes en su mayoría deseaban información sobre las opciones quirúrgicas y la función intestinal. Tanto los pacientes como los cirujanos querían una herramienta que fuera personalizada, simple, comprensible, visualmente atractiva, interactiva, corta y en múltiples formatos.LIMITACIONES:Los resultados pueden no ser generalizables debido al sesgo de selección de los participantes.CONCLUSIÓN:Los sobrevivientes de cáncer rectal, sus cuidadores y los cirujanos colorrectales querían una herramienta de apoyo educativo que cubriera las necesidades educativas sustanciales a lo largo del tratamiento de la enfermedad en lugar de una ayuda para la decisión quirúrgica que se centre solo en una opción quirúrgica discreta. Consulte Video Resumen en http://links.lww.com/DCR/C20 . (Traducción-Dr. Yolanda Colorado ).

Co-Development of a Web Application (COVID-19 Social Site) for Long-Term Care Workers ("Something for Us"): User-Centered Design and Participatory Research Study.

BACKGROUND: Improving confidence in and uptake of COVID-19 vaccines and boosters among long-term care workers (LTCWs) is a crucial public health goal, given their role in the care of elderly people and people at risk. While difficult to reach with workplace communication interventions, most LTCWs regularly use social media and smartphones. Various social media interventions have improved attitudes and uptake for other vaccines and hold promise for the LTCW population. OBJECTIVE: We aimed to develop a curated social web application (interactive website) to increase COVID-19 vaccine confidence (a 3-arm randomized trial is underway). METHODS: Following user-centric design and participatory research approaches, we undertook the following 3 steps: (1) content identification, (2) platform development, and (3) community building. A LTCW and stakeholder advisory group provided iterative input. For content identification (step 1), we identified topics of concern about COVID-19 vaccines via desktop research (published literature, public opinion polls, and social media monitoring), refined by interviewing and polling LTCWs. We also conducted a national online panel survey. We curated and fact-checked posts from popular social media platforms that addressed the identified concerns. During platform development (step 2), we solicited preferences for design and functionality via interviews and user experience testing with LTCWs. We also identified best practices for online community building (step 3). RESULTS: In the interviews (n=9), we identified 3 themes: (1) LTCWs are proud of their work but feel undervalued; (2) LTCWs have varying levels of trust in COVID-19-related information; and (3) LTCWs would welcome a curated COVID-19 resource that is easy to understand and use-"something for us". Through desktop research, LTCW interviews, and our national online panel survey (n=592) we found that participants are interested in information about COVID-19 in general, vaccine benefits, vaccine risks, and vaccine development. Content identification resulted in 434 posts addressing these topic areas, with 209 uploaded to the final web application. Our LTCW poll (n=8) revealed preferences for personal stories and video content. The platform we developed is an accessible WordPress-based social media web application, refined through formal (n=3) and informal user experience testing. Users can sort posts by topic or subtopic and react to or comment on posts. To build an online community, we recruited 3 LTCW "community ambassadors" and instructed them to encourage discussion, acknowledge concerns, and offer factual information on COVID-19 vaccines. We also set "community standards" for the web application. CONCLUSIONS: An iterative, user-centric, participatory approach led to the launch of an accessible social media web application with curated content for COVID-19 vaccines targeting LTCWs in the United States. Through our trial, we will determine if this approach successfully improves vaccine confidence. If so, a similar social media resource could be used to develop curated social media interventions in other populations and with other public health goals.

[Decision aids for addictions: the example of smoking cessation]. / Outils d'aide à la décision dans les addictions : lexemple du tabac.

Decision aids (DAs) help patients participate in healthcare decisions by improving knowledge and clarifying values and preferences, thus favoring a more active role in the decision process. DAs exist as a physical support (paper, DVD, audio) or computerized formats. They can be used independently by patients before and after consultations, or with a health professional during consultations. Unisanté has created a DA for use during consultations presenting available smoking cessation aids (www.howtoquit.ch). A local study showed that the DA is considered easy to use and useful by the doctors interviewed. The use of DAs in addictions to other substances, in conjunction with shared decision making, shows a favourable effect on the involvement of patients in their health and therapeutic adherence.

Les outils d'aide à la décision (AD) soutiennent les patient-e-s dans leurs choix médicaux en majorant leurs connaissances et en clarifiant leurs valeurs et préférences, ce qui leur permet de s'impliquer dans le processus décisionnel. Les AD existent en tant que supports physiques (papier, DVD) ou informatiques. Ils peuvent être utilisés par les patient-e-s avant/après la consultation ou avec le-la professionnel-le de santé durant la consultation. Unisanté a créé un AD présentant les aides à l'arrêt du tabac durant la consultation. Une étude locale a montré que l'usage de celui-ci a été jugé simple et utile par les médecins. L'utilisation d'AD dans les addictions à d'autres substances, renforcée par des entretiens de décision partagée, montre un effet favorable sur l'implication des patient-e-s et sur l'adhésion thérapeutique.

[Information materials for colorectal cancer screening for citizens with low health literacy]. / Information sur le dépistage du cancer colorectal adaptée pour les citoyens à faible littératie en santé - Nouveaux outils.

For multiple reasons, certain socially disadvantaged populations are more affected by colorectal cancer but have lower screening rates than wealthier populations. The Vaud colorectal cancer screening program (CCR) provides a 20-page decision support tool for the 50-69-year-old population. Three new tools have now been designed specifically for citizens with a low level of health literacy: a simplified 6-page leaflet presenting the choice of a Fecal Occult Blood Test (FIT) and colonoscopy; a 2-page leaflet presenting the detection and screening of 4 common cancers; and a short video presenting the FIT test. By adapting our approach to each individual's level of health literacy, we can ensure a shared decision for all.

Pour des raisons multiples, certaines populations en situation de vulnérabilité sont davantage touchées par le cancer colorectal (CCR) mais ont des taux de dépistage plus bas que les populations plus aisées. Le programme de dépistage du CCR vaudois adresse un outil d'aide à la décision de 20 pages à la population de 50 à 69 ans. Trois nouveaux outils ont été conçus spécifiquement pour les citoyen-ne-s avec un faible niveau de littératie en santé: un dépliant simplifié de 6 pages présentant le choix d'un test immunologique de recherche de sang occulte dans les selles (FIT) et de coloscopie; un dépliant de 2 pages présentant la détection et le dépistage de 4 cancers fréquents; et une courte vidéo présentant le test FIT. En adaptant notre approche au niveau de littératie en santé, nous pouvons favoriser une décision partagée pour tous et toutes.

What matters most: Randomized controlled trial of breast cancer surgery conversation aids across socioeconomic strata.

BACKGROUND: Women of lower socioeconomic status (SES) with early-stage breast cancer are more likely to report poorer physician-patient communication, lower satisfaction with surgery, lower involvement in decision making, and higher decision regret compared to women of higher SES. The objective of this study was to understand how to support women across socioeconomic strata in making breast cancer surgery choices. METHODS: We conducted a 3-arm (Option Grid, Picture Option Grid, and usual care), multisite, randomized controlled superiority trial with surgeon-level randomization. The Option Grid (text only) and Picture Option Grid (pictures plus text) conversation aids were evidence-based summaries of available breast cancer surgery options on paper. Decision quality (primary outcome), treatment choice, treatment intention, shared decision making (SDM), anxiety, quality of life, decision regret, and coordination of care were measured from T0 (pre-consultation) to T5 (1-year after surgery. RESULTS: Sixteen surgeons saw 571 of 622 consented patients. Patients in the Picture Option Grid arm (n = 248) had higher knowledge (immediately after the visit [T2] and 1 week after surgery or within 2 weeks of the first postoperative visit [T3]), an improved decision process (T2 and T3), lower decision regret (T3), and more SDM (observed and self-reported) compared to usual care (n = 257). Patients in the Option Grid arm (n = 66) had higher decision process scores (T2 and T3), better coordination of care (12 weeks after surgery or within 2 weeks of the second postoperative visit [T4]), and more observed SDM (during the surgical visit [T1]) compared to usual care arm. Subgroup analyses suggested that the Picture Option Grid had more impact among women of lower SES and health literacy. Neither intervention affected concordance, treatment choice, or anxiety. CONCLUSIONS: Paper-based conversation aids improved key outcomes over usual care. The Picture Option Grid had more impact among disadvantaged patients. LAY SUMMARY: The objective of this study was to understand how to help women with lower incomes or less formal education to make breast cancer surgery choices. Compared with usual care, a conversation aid with pictures and text led to higher knowledge. It improved the decision process and shared decision making (SDM) and lowered decision regret. A text-only conversation aid led to an improved decision process, more coordinated care, and higher SDM compared to usual care. The conversation aid with pictures was more helpful for women with lower income or less formal education. Conversation aids with pictures and text helped women make better breast cancer surgery choices.

Women Who Are Young, Non-White, and with Lower Socioeconomic Status Report Higher Financial Toxicity up to 1 Year After Breast Cancer Surgery: A Mixed-Effects Regression Analysis.

PURPOSE: We examined self-reported financial toxicity and out-of-pocket expenses among adult women with breast cancer. METHODS: Patients spoke English, Spanish, or Mandarin Chinese, were aged 18+ years, had stage I-IIIA breast cancer, and were eligible for breast-conserving and mastectomy surgery. Participants completed surveys about out-of-pocket costs and financial toxicity at 1 week, 12 weeks, and 1 year postsurgery. RESULTS: Three hundred ninety-five of 448 eligible patients (88.2%) from the parent trial completed surveys. Excluding those reporting zero costs, crude mean ± SD out-of-pocket costs were $1,512 ± $2,074 at 1 week, $2,609 ± $6,369 at 12 weeks, and $3,308 ± $5,000 at 1 year postsurgery. Controlling for surgery, cancer stage, and demographics with surgeon and clinic as random effects, higher out-of-pocket costs were associated with higher financial toxicity 1 week and 12 weeks postsurgery (p < .001). Lower socioeconomic status (SES) was associated with lower out-of-pocket costs at each time point (p = .002-.013). One week postsurgery, participants with lower SES reported financial toxicity scores 1.02 points higher than participants with higher SES (95% confidence interval [CI], 0.08-1.95). Black and non-White/non-Black participants reported financial toxicity scores 1.91 (95% CI, 0.46-3.37) and 2.55 (95% CI, 1.11-3.99) points higher than White participants. Older (65+ years) participants reported financial toxicity scores 2.58 points lower than younger (<65 years) participants (95% CI, -3.41, -1.74). Younger participants reported significantly higher financial toxicity at each time point. DISCUSSION: Younger age, non-White race, and lower SES were associated with higher financial toxicity regardless of costs. Out-of-pocket costs increased over time and were positively associated with financial toxicity. Future work should reduce the impact of cancer care costs among vulnerable groups. IMPLICATIONS FOR PRACTICE: This study was one of the first to examine out-of-pocket costs and financial toxicity up to 1 year after breast cancer surgery. Younger age, Black race, race other than Black or White, and lower socioeconomic status were associated with higher financial toxicity. Findings highlight the importance of addressing patients' financial toxicity in several ways, particularly for groups vulnerable to its effects.

Impact of Knowledge and Risk Perceptions on Older Adults' Intention for Surveillance Colonoscopy.

GOALS: The authors aimed to characterize older adults' intentions for future surveillance colonoscopy, knowledge of polyps, and predictors of colonoscopy plans. BACKGROUND: Guidelines recommend that the decision to continue or stop surveillance colonoscopy in older adults with colon polyps be "individualized." Although older adults want to be included in decision making, how knowledge regarding polyps influences decisions is unknown. STUDY: In collaboration with a rural family medicine practice, the authors invited adults aged 65 years and older with a history of colon adenomas to complete a 14-item survey regarding intention for colonoscopy and knowledge of colon polyps. RESULTS: Sixty-seven of 105 (63%) patients completed the survey. The mean age was 72 years. Regarding future surveillance, 53% planned to return, 25% were unsure, and 22% did not plan to return. There were no significant differences in baseline characteristics on the basis of the intention for future colonoscopy. Regarding polyp knowledge, 73% had correct knowledge around how common polyps are; 50% thought that more than half of untreated polyps would become cancerous-an inaccurately elevated perception by 10 folds. Respondents who perceived polyps to have a high malignant potential were more likely to report plans for surveillance colonoscopy (68% vs. 39%; P=0.03). CONCLUSIONS: In this survey of older adults with a history of polyps, many had a falsely elevated perception of polyps' potential for cancer that was associated with a higher intention for future colonoscopy. Ensuring older adults have an understanding of the risks of polyps is an essential step toward improving decision making around surveillance colonoscopy.

Processes for evidence summarization for patient decision aids: A Delphi consensus study.

BACKGROUND: Patient decision aids (PDAs) should provide evidence-based information so patients can make informed decisions. Yet, PDA developers do not have an agreed-upon process to select, synthesize and present evidence in PDAs. OBJECTIVE: To reach the consensus on an evidence summarization process for PDAs. DESIGN: A two-round modified Delphi survey. SETTING AND PARTICIPANTS: A group of international experts in PDA development invited developers, scientific networks, patient groups and listservs to complete Delphi surveys. DATA COLLECTION: We emailed participants the study description and a link to the online survey. Participants were asked to rate each potential criterion (omit, possible, desirable, essential) and provide qualitative feedback. ANALYSIS: Criteria in each round were retained if rated by >80% of participants as desirable or essential. If two or more participants suggested rewording, reordering or merging, the steering group considered the suggestion. RESULTS: Following two Delphi survey rounds, the evidence summarization process included defining the decision, reporting the processes and policies of the evidence summarization process, assembling the editorial team and managing (collect, manage, report) their conflicts of interest, conducting a systematic search, selecting and appraising the evidence, presenting the harms and benefits in plain language, and describing the method of seeking external review and the plan for updating the evidence (search, selection and appraisal of new evidence). CONCLUSION: A multidisciplinary stakeholder group reached consensus on an evidence summarization process to guide the creation of high-quality PDAs. PATIENT CONTRIBUTION: A patient partner was part of the steering group and involved in the development of the Delphi survey.

Impact of a health literacy intervention combining general practitioner training and a consumer facing intervention to improve colorectal cancer screening in underserved areas: protocol for a multicentric cluster randomized controlled trial.

BACKGROUND: Colorectal cancer (CRC) is a leading cause of cancer burden worldwide. In France, it is the second most common cause of cancer death after lung cancer. Systematic uptake of CRC screening can improve survival rates. However, people with limited health literacy (HL) and lower socioeconomic position rarely participate. Our aim is to assess the impact of an intervention combining HL and CRC screening training for general practitioners (GPs) with a pictorial brochure and video targeting eligible patients, to increase CRC screening and other secondary outcomes, after 1 year, in several underserved geographic areas in France. METHODS: We will use a two-arm multicentric randomized controlled cluster trial with 32 GPs primarily serving underserved populations across four regions in France with 1024 patients recruited. GPs practicing in underserved areas (identified using the European Deprivation Index) will be block-randomized to: 1) a combined intervention (HL and CRC training + brochure and video for eligible patients), or 2) usual care. Patients will be included if they are between 50 and 74 years old, eligible for CRC screening, and present to recruited GPs. The primary outcome is CRC screening uptake after 1 year. Secondary outcomes include increasing knowledge and patient activation. After trial recruitment, we will conduct semi-structured interviews with up to 24 GPs (up to 8 in each region) and up to 48 patients (6 to 12 per region) based on data saturation. We will explore strategies that promote the intervention's sustained use and rapid implementation using Normalization Process Theory. We will follow a community-based participatory research approach throughout the trial. For the analyses, we will adopt a regression framework for all quantitative data. We will also use exploratory mediation analyses. We will analyze all qualitative data using a framework analysis guided by Normalization Process Theory. DISCUSSION: Limited HL and its impact on the general population is a growing public health and policy challenge worldwide. It has received limited attention in France. A combined HL intervention could reduce disparities in CRC screening, increase screening rates among the most vulnerable populations, and increase knowledge and activation (beneficial in the context of repeated screening). TRIAL REGISTRATION: Registry: ClinicalTrials.gov. TRIAL REGISTRATION NUMBER: 2020-A01687-32 . Date of registration: 17th November 2020.

Integrating Option Grid Patient Decision Aids in the Epic Electronic Health Record: Case Study at 5 Health Systems.

BACKGROUND: Some researchers argue that the successful implementation of patient decision aids (PDAs) into clinical workflows depends on their integration into electronic health records (EHRs). Anecdotally, we know that EHR integration is a complex and time-consuming task; yet, the process has not been examined in detail. As part of an implementation project, we examined the work involved in integrating an encounter PDA for symptomatic uterine fibroids into Epic EHR systems. OBJECTIVE: This study aims to identify the steps and time required to integrate a PDA into the Epic EHR system and examine facilitators and barriers to the integration effort. METHODS: We conducted a case study at 5 academic medical centers in the United States. A clinical champion at each institution liaised with their Epic EHR team to initiate the integration of the uterine fibroid Option Grid PDAs into clinician-facing menus. We scheduled regular meetings with the Epic software analysts and an expert Epic technologist to discuss how best to integrate the tools into Epic for use by clinicians with patients. The meetings were then recorded and transcribed. Two researchers independently coded the transcripts and field notes before categorizing the codes and conducting a thematic analysis to identify the facilitators and barriers to EHR integration. The steps were reviewed and edited by an Epic technologist to ensure their accuracy. RESULTS: Integrating the uterine fibroid Option Grid PDA into clinician-facing menus required an 18-month timeline and a 6-step process, as follows: task priority negotiation with Epic software teams, security risk assessment, technical review, Epic configuration; troubleshooting, and launch. The key facilitators of the process were the clinical champions who advocated for integration at the institutional level and the presence of an experienced technologist who guided Epic software analysts during the build. Another facilitator was the use of an emerging industry standard app platform (Health Level 7 Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources) as a means of integrating the Option Grid into existing systems. This standard platform enabled clinicians to access the tools by using single sign-on credentials and prevented protected health information from leaving the EHR. Key barriers were the lack of control over the Option Grid product developed by EBSCO (Elton B Stephens Company) Health; the periodic Epic upgrades that can result in a pause on new software configurations; and the unforeseen software problems with Option Grid (ie, inability to print the PDA), which delayed the launch of the PDA. CONCLUSIONS: The integration of PDAs into the Epic EHR system requires a 6-step process and an 18-month timeline. The process required support and prioritization from a clinical champion, guidance from an experienced technologist, and a willing EHR software developer team.

[Three approaches to doctor-patient communication and prevention : Which model for which situation ?] / Trois approches de communication médecin-patient et prévention : quel modèle pour quelle situation ?

Doctors learn different communication approaches for use during prevention consultations to promote healthy habits, so as to set up a partnership and to promote patient autonomy. Three of these approaches are shared decision making, when there is more than one reasonable choice, motivational interviewing, principally for behaviour change and therapeutic education, a pedagogical approach helping patients develop skills so that they may have a better management of their chronic illness. This article presents an overview of the commonalities and the differences between these approaches, often considered separately, nevertheless they are complementary and in practice, using elements of all three during a consultation could improve preventative care.

Les médecins apprennent différentes approches de communication utilisées lors des consultations de prévention afin de promouvoir des comportements sains, créer un partenariat avec le patient et favoriser son autonomie. Trois des approches les plus courantes sont : la décision partagée lorsqu'il y a plus d'un choix raisonnable, l'entretien motivationnel pour le changement de comportement et l'éducation thérapeutique, une approche pédagogique visant le développement de compétence des patients pour une gestion optimale des maladies chroniques. Nous présentons ici une vision d'ensemble des similarités et des différences entre ces approches, car, souvent considérées en silos, elles sont néanmoins complémentaires et, en pratique, utiliser des éléments tirés des trois durant une consultation pourrait améliorer la prise en charge.

[Risk communication in healthcare: literature review and recommendations for clinical practice]. / Communication des risques en santé†: revue de littérature et recommandations pour la pratique clinique.

Consistent with the principles of evidence-based medicine, communicating clinical risks to patients and their families is an essential part of informed consent and decision-making. Communication of clinical risks can take place during and after consultations, orally or in writing, based on the latest available scientific data, when available. Numerous studies show that there are different degrees of innumeracy in the general population, meaning more or less significant difficulties mastering numbers in everyday situations. It is therefore imperative to communicate risks in a way that is adapted to the patients' variable numeracy and health literacy levels. This article presents a synthesis of international research on risk communication, as well as recommendations for clinical practice.

En conformité avec les principes de médecine basée sur les preuves, communiquer les risques cliniques aux patients et à leurs proches est un préambule essentiel au consentement et à la prise de décision éclairée. La communication des risques cliniques peut s'effectuer pendant et après les consultations, verbalement ou par écrit, en s'appuyant sur les dernières données scientifiques disponibles. De nombreuses études démontrent que la population est confrontée à différents degrés d'innumérisme, soit des difficultés plus ou moins importantes dans la maîtrise des chiffres. Il est ainsi impératif de communiquer les risques de façon adaptée aux numératie et littératie en santé variables des patients. Cet article présente une synthèse des travaux internationaux sur la communication des risques, ainsi que des recommandations pour la pratique clinique.