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.

Patients' Perceived Importance of Medication and Adherence in Polypharmacy, a Quantitative, Cross-Sectional Study Using a Questionnaire Administered in Three Doctors' Private Practices in France.

BACKGROUND: Among the determinants of nonadherence, polypharmacy (common in people with multiple pathologies and especially in elderly patients), plays a major role. OBJECTIVE: In patients who are subject to polypharmacy involving different classes of medications, the first aim is to assess the impact of medication importance given by patients on (i) medication adherence and (ii) the respective effect of intentionality and habit in medication importance and medication adherence. The second objective is to compare the importance given to medication and adherence in the different therapeutic classes. PATIENTS AND METHODS: Patients taking 5-10 different medications for at least 1 month were included in a cross-sectional survey in three private practices in one region in France. RESULTS: This study included 130 patients (59.2 % female) with 851 medications in total. The mean ± standard deviation (SD) age was 70.5 ± 12.2 years. The mean ± SD of medications taken was 6.9 ± 1.7. Treatment adherence had a strong positive correlation with the patient-perceived medication importance (p < 0.001). Counter-intuitively, taking a large number of medications (≥7) was associated with being fully adherent (p = 0.02). A high intentional nonadherence score was negatively associated with high medication importance (p = 0.003). Furthermore, patient-perceived medication importance was positively associated with taking treatment by habit (p = 0.03). Overall nonadherence more strongly correlated with unintentional nonadherence (p < 0.001) than with intentional nonadherence (p = 0.02). Compared to the antihypertensive class, a decrease in adherence by medication was observed in psychoanaleptics (p < 0.0001) and drugs used in diabetes class (p = 0.002), and a decrease in importance in lipid-modifying agents class (p = 0.001) and psychoanaleptics (p < 0.0001). CONCLUSION: The perception of the importance of a medicine is associated with the place of intentionality and habit in patient adherence. Therefore, explaining the importance of a medicine should become an important part of patient education.

Interactive Inflammatory Bowel Disease Biologics Decision Aid Does Not Improve Patient Outcomes Over Static Education: Results From a Randomized Trial.

INTRODUCTION: To support shared decision-making (SDM) between patients and providers surrounding biologic treatments, we created IBD&me ( ibdandme.org )-a freely available, unbranded, interactive decision aid. We performed a multicenter comparative effectiveness trial comparing the impact of IBD&me on SDM vs a biologics fact sheet developed by the Crohn's & Colitis Foundation. METHODS: We enrolled patients with inflammatory bowel disease (IBD) being seen at a clinic within IBD Qorus-a multicenter adult IBD learning health system-between March 5, 2019, and May 14, 2021. Eligible patients included those with recent IBD-related symptoms who reported that they wanted to discuss biologics with their provider during their upcoming visit. Patients were randomized 1:1 using stratified block randomization and received an e-mail 1 week before their visit inviting them to review either IBD&me or a fact sheet. The primary outcome was patient perception of SDM as measured by the 9-Item SDM Questionnaire (0-100 scale; higher = better); the Student t test was used to compare outcomes between arms. RESULTS: Overall, 152 patients were randomized (biologics fact sheet 75, IBD&me 77); most patients had Crohn's disease (66.4%) and were biologic-experienced (82.9%). No differences were seen between groups regarding SDM (fact sheet 72.6 ± 25.6, IBD&me 75.0 ± 20.8; P = .57). Most patients stated they would be likely to recommend the fact sheet (79.6%) or IBD&me (84.9%; P = .48) to another patient with IBD. DISCUSSION: No differences in outcomes were seen between IBD&me and the biologics fact sheet in this comparative effectiveness study; patients reported high satisfaction with both resources. Further study, particularly among biologic naïve patients, is needed to determine the utility of interactive components to IBD decision aids.

Impact of a phone call with a medical student/general practitioner team on morbidity of chronic patients during the first French COVID-19 lockdown (COVIQuest): a cluster randomised trial.

OBJECTIVES: The first COVID-19 lockdown led to a significantly reduced access to healthcare, which may have increased decompensations in frail patients with chronic diseases, especially older patients living with a chronic cardiovascular disease (CVD) or a mental health disorder (MHD). The objective of COVIQuest was to evaluate whether a general practitioner (GP)-initiated phone call to patients with CVD and MHD during the COVID-19 lockdown could reduce the number of hospitalisation(s) over a 1-month period. DESIGN: This is a cluster randomised controlled trial. Clusters were GPs from eight French regions. PARTICIPANTS: Patients ≥70 years old with chronic CVD (COVIQuest_CV subtrial) or ≥18 years old with MHD (COVIQuest_MH subtrial). INTERVENTIONS: A standardised GP-initiated phone call aiming to evaluate patients' need for urgent healthcare, with a control group benefiting from usual care (ie, the contact with the GP was by the patient's initiative). MAIN OUTCOME MEASURES: Hospital admission within 1 month after the phone call. RESULTS: In the COVIQuest_CV subtrial, 131 GPs and 1834 patients were included in the intervention group and 136 GPs and 1510 patients were allocated to the control group. Overall, 65 (3.54%) patients were hospitalised in the intervention group vs 69 (4.57%) in the control group (OR 0.82, 95% CI 0.56 to 1.20; risk difference -0.77, 95% CI -2.28 to 0.74). In the COVIQuest_MH subtrial, 136 GPs and 832 patients were included in the intervention group and 131 GPs and 548 patients were allocated to the control group. Overall, 27 (3.25%) patients were hospitalised in the intervention group vs 12 (2.19%) in the control group (OR 1.52, 95% CI 0.82 to 2.81; risk difference 1.38, 95% CI 0.06 to 2.70). CONCLUSION: A GP-initiated phone call may have been associated with more hospitalisations within 1 month for patients with MHD, but results lack robustness and significance depending on the statistical approach used. TRIAL REGISTRATION NUMBER: NCT04359875.

Acceptability of and Willingness to Take Digital Pills by Patients, the Public, and Health Care Professionals: Qualitative Content Analysis of a Large Online Survey.

BACKGROUND: Digital pills are pills combined with a sensor, which sends a signal to a patch connected to a smartphone when the pills are ingested. Health care professionals can access patient data from digital pills online via their own interface, thus allowing them to check whether a patient took the drug. Digital pills were developed for the stated goal of improving treatment adherence. The US Food and Drug Administration approved the first digital pills in November 2017, but the manufacturer withdrew its application to the European Medicines Agency in July 2020 because of insufficient evaluation. OBJECTIVE: As recommended for the evaluation of health technologies, this study assesses the prospective acceptability of and willingness to take digital pills among patients, the public, and health care professionals. METHODS: Participants were patients who were receiving long-term treatment for a chronic condition, public participants (both groups recruited from a representative sample), and health care professionals. Participants answered 5 open-ended questions regarding the acceptability of digital pills and 1 close-ended question regarding the willingness to take digital pills, which were developed in a preliminary qualitative study. We explored the 5 theoretical dimensions of acceptability by performing an abductive qualitative content analysis of all free-text responses. We assessed data saturation with mathematical models. We fitted a multivariate logistic regression model to identify the sociodemographic and health characteristics associated with the willingness to take digital pills. RESULTS: Between January 29, 2020, and April 18, 2020, 767 patients, 1238 public participants, and 246 health care professionals provided 11,451 free-text responses. We identified 98 codes related to the acceptability of digital pills: 29 codes on perceived clinical effectiveness (eg, sensor safety cited by 66/2251 participants, 29.5%), 6 on perceived burden (eg, increased doctors' workload, 164/2251 participants, 7.3%), 25 on perceived ethicality (eg, policing, 345/2251 participants, 15.3%), 30 codes on perceived opportunity (eg, exclusively negative perception, 690/2251 participants, 30.7%), and 8 on affective attitude (eg, anger, 541/2251, 24%). Overall, 271/767 (35.3%) patients, 376/1238 (30.4%) public participants, and 39/246 (15.8%) health care professionals reported willingness to take digital pills. This willingness was associated with male sex (odds ratio 1.98, 95% CI 1.62-2.43) and current use of a connected device to record health settings (with a dose-response relationship). CONCLUSIONS: The prospective acceptability of and willingness to take digital pills were limited by clinical and ethical concerns both at the individual and societal level. Our results suggest that digital pills should not be considered a mere change in the form of drug administration but a complex intervention requiring specific evaluation before extended use in clinical routine practice as well as an ethical and legal framework to ensure safe and ethical collection and use of health data through a patient-centered approach.

Impact of an interactive web tool on patients' intention to receive COVID-19 vaccination: a before-and-after impact study among patients with chronic conditions in France.

OBJECTIVES: In France, about 30% of the population refuses COVID-19 vaccination outright, and 9 to 40% are hesitant. We developed and evaluated an interactive web tool providing transparent and reliable information on the benefits and risks of COVID-19 vaccination. METHODS: The most recent scientific data at the time of the study were implemented into an interactive web tool offering individualized information on the risks of COVID-19 infection-related events versus vaccination-related serious adverse events. The tool was evaluated during a before-and-after impact study nested in ComPaRe, a French e-cohort of adult patients with chronic conditions. Primary outcome was the proportion of patients intending to receive vaccination after using the tool, among those not intending to receive it at baseline. RESULTS: Between January 8 and 14, 2021, we enrolled 3152 patients in the study [mean age 55.2 (SD: 16.9), 52.9% women and 63% with ≥ 2 chronic conditions]. Before consulting the tool, 961 (30.5%) refused to be vaccinated until further data on efficacy/safety was obtained and 239 (7.5%) outright refused vaccination. Among these 1200 patients, 96 (8.0%, number needed to treat: 12.5) changed their mind after consulting the tool and would subsequently accept vaccination. CONCLUSIONS: Our interactive web tool represents a scalable method to help increase the intent to receive COVID-19 vaccination among patients with chronic conditions and address vaccine hesitancy. Since April 2021, our tool has been embedded on the official webpage of the French Government for COVID-19 information.

Titrated baclofen for high-risk alcohol consumption: a randomized placebo-controlled trial in out-patients with 1-year follow-up.

BACKGROUND AND AIMS: Baclofen is a promising drug for treating patients with alcohol-related disorders. Nevertheless, the first randomized clinical trials (mainly with target doses) reported inconsistent efficacy, possibly because of the effective dose widely varying between patients. The Bacloville study aimed to test the efficacy of titrated baclofen for achieving low-risk alcohol consumption. DESIGN: Twelve-month multicenter pragmatic double-blind randomized clinical trial from June 2012 to June 2014. SETTING: Sixty-two French primary care centers. PARTICIPANTS: Out-patients with high-risk alcohol consumption (> 40 g/day for women and > 60 g/day for men). INTERVENTION AND COMPARATOR: Patients were randomly assigned (1 : 1 ratio) to receive titrated baclofen up to 300 mg/day or placebo for 12 months. Switching to open-label baclofen was allowed in cases of perceived inefficacy. MEASUREMENTS: The primary outcome defined success as no or low-risk alcohol consumption (≤ 20 g/day for women and ≤ 40 g/day for men) during the last month of the 1-year follow up, with patients who switched to open-label baclofen classified as failures. FINDINGS: A total of 320 patients were randomized, 162 to baclofen and 158 to placebo (consumption 129 g/day in both arms). Discontinuation rates were 30 and 34% in the baclofen and placebo arms, respectively, and return rates of the last-month diaries were 42 and 34%, respectively. Primary success rates were 57 and 36% in the baclofen and placebo arms, respectively [difference: 21 percentage points, 95% confidence interval (CI) = 8-34, P = 0.003]. When switchers were not classified as failures unless they failed, the success rates were 62 versus 55% (difference: 6 percentage points, 95% CI = -7 to 20). Over 12 months, daily consumption differed between both arms (11 g less in the baclofen arm), as did the number of abstinence days (3.3 days more in the baclofen arm). Adverse events were more frequent with baclofen than placebo and were mostly drowsiness, fatigue and insomnia. Serious adverse events occurred in 85 (seven deaths) and 36 (three deaths) patients with baclofen and placebo, respectively. CONCLUSIONS: Baclofen was more effective than placebo in reducing alcohol consumption to low-risk levels. The number of adverse events and more serious adverse events was greater with baclofen than placebo.

Patient-Physician Agreement in Reporting and Prioritizing Existing Chronic Conditions.

PURPOSE: In this study, we aimed to assess (1) the agreement between patient self-reports and general practitioner (GP) reports of the chronic conditions affecting the patients and (2) the agreement between patients and GPs on health priorities in a primary care setting. METHOD: Patients were recruited in the Parisian area of France by a convenience sample of GPs; eligibility criteria required that the GP was the patient's listed primary care provider for at least 12 months. Participants were asked to report all the patient's current chronic conditions by using a previously developed list of 124 chronic conditions and write a list of up to 3 priority conditions. RESULTS: From April to May 2017, 233 patients were recruited from 16 GP practices. Agreement between the number of conditions reported by patients and by GPs was moderate (intraclass correlation coefficient 0.59, 95% CI, 0.50 to 0.69). Agreement between patient self-reports and GP reports of each chronic condition ranged from very good (eg, κ = 0.85 for hypothyroidism) to poor (eg, κ = 0.12 for chronic anxiety disorder). Among the 153 patient-GP pairs for which both the patient and GP wrote a priority list, 45 (29.4%) of patients' first priorities did not appear anywhere on the corresponding GPs' lists, and 19 (12.4%) pairs had no matching priority condition. CONCLUSIONS: Agreement between patients and their GPs varied widely depending on the diseases reported. Low agreement on health priorities suggests a need for improvement to ensure better alignment between patient and physician perspectives.

Acceptable medication non-adherence: A crowdsourcing study among French physicians for commonly prescribed medications.

BACKGROUND: Achieving good medication adherence is a major challenge for patients with chronic conditions. Our study aimed to assess the Threshold for Unacceptable Risk of Non-adherence (TURN), defined as the threshold at which physicians consider the health risks incurred by patients due to medication non-adherence unacceptable, for the most commonly prescribed drugs in France. METHODS: We conducted an online study using a crowdsourcing approach among French general practitioners and specialists from September 2016 to August 2017. Physicians assessed the TURN for various levels of missed doses by evaluating a series of randomly presented clinical vignettes, each presenting a given medication with a given therapeutic indication. For each "drug-indication group" (i.e., all drugs from the same pharmacological class with a similar therapeutic indication): 1) we described the distribution of physicians' assessments, 2) we provided a summary estimate of the TURN, defined as the frequency of missed doses above which 75% of the physicians' assessments were located; 3) we computed the number of pill boxes reimbursed in France in 2016 to put our results into context. RESULTS: We collected a total of 5365 assessments from 544 physicians, each of whom evaluated a random sample among 528 distinct clinical vignettes. Estimates of the TURN varied widely across drug-indication groups, ranging from risk considered unacceptable with 1 daily dose missed per month (e.g., insulin for diabetes) to risk always considered acceptable (e.g., anti-dementia drugs). Drugs with an estimated TURN of over one missing daily dose per week represented 44.9% of the prescription volume of the medications assessed in our study. CONCLUSIONS: According to physicians, the impact of non-adherence may vary greatly. Patient-physician discussions on the variable consequences of non-adherence could lead to a paradigm shift by seeking to reach "optimal adherence" depending on drugs rather than unrealistic "perfect adherence" to all drugs.

Tailored-Dose Baclofen in the Management of Alcoholism: A Retrospective Study of 144 Outpatients Followed for 3 Years in a French General Practice.

Background: More information is needed about the efficacy and safety of long-term baclofen in the treatment of alcohol use disorders. The objective of this study was to assess the effect of treatment with tailored-dose baclofen on alcohol consumption in patients with alcohol use disorders followed for 3 years after first initiating baclofen treatment. Methods: This retrospective descriptive cohort included outpatients followed in a French general practice clinic for 3 years and treated with tailored-dose baclofen to reduce or eliminate alcohol consumption. At 3 years, treatment was considered successful if alcohol consumption was at or below levels defined as low-risk by the WHO (≤ 40 g/d in men and ≤ 20 g/d in women). Results: The study population included 144 patients (88 men and 56 women). The participants' mean age was 46 ± 11 years and mean daily alcohol intake before treatment was 167 ± 77 grams. At the end of the study, treatment was successful for 91 (63.2%) patients. Participants' mean dose of baclofen at the end of study period was 100 ± 101 mg/d. We identified 75 (52.1%) patients for whom treatment was successful at each annual follow-up appointment: at 1, 2, and 3 years. The mean maximum dose of baclofen over follow-up of the 144 patients was 211 ± 99 mg/d (dose range: 40 mg/d to 520 mg/d). Conclusion: In this study, tailored-dose baclofen appears to be an effective treatment in patients with alcohol use disorders, with sustainable effect over time (3 years). There are many adverse effects but they are consistent with those already described in the literature.

Discordance Between Drug Adherence as Reported by Patients and Drug Importance as Assessed by Physicians.

PURPOSE: Among patients on long-term medical therapy, we compared (1) patient and physician assessments of drug adherence and of drug importance and (2) drug adherence reported by patients with drug importance as assessed by their physicians. METHODS: We recruited to the study patients receiving at least 1 long-term drug treatment from both hospital and ambulatory settings in France. We compared drug adherence reported by patients and drug importance assessed by physicians using Spearman correlation coefficients. Reasons for nonadherence were collected with open-ended questions and classified as intentional or unintentional. RESULTS: Between April and August 2014, we recruited 128 patients taking 498 drugs. Patients and physicians showed only weak agreement in their assessments of drug adherence (r = -0.25; 95% CI, -0.37 to -0.11) and drug importance (r = 0.07; 95% CI, 0.00 to 0.13). We did not find any correlation between physician-assessed drug importance and patient-reported drug adherence (r = -0.04; 95% CI, -0.14 to 0.06). In all, 94 (18.9%) of the drugs that physicians considered important were not correctly taken by patients. Patients intentionally did not adhere to 26 (48.1%) of the drugs for which they reported reasons for nonadherence. CONCLUSIONS: We found substantial discordance between patient and physician evaluations of drug adherence and drug importance. Nearly 20% of drugs considered important by physicians were not correctly taken by patients. These findings highlight the need for better patient-physician collaboration in drug treatment.

Development and validation of an instrument to assess treatment adherence for each individual drug taken by a patient.

OBJECTIVE: To develop and validate an instrument to assess adherence to each individual drug taken by patients undergoing long-term treatment. DESIGN: Multicentre prospective observational validation study. SETTING: Six general practitioners' clinics and 6 university hospitals in Paris, France. PARTICIPANTS: Patients 18 years and older receiving at least one long-term treatment. METHODS: The instrument was developed from a literature search and interviews with experts. Clarity and wording were assessed during pilot testing with 51 patients. The tool was validated in a sample of consecutive patients. We assessed agreement between adherence measured with our tool and drug diaries and compared measurements from our instrument with (1) the Lu instrument; (2) the Adherence Estimator (AE); (3) patient's adherence assessed by physicians; (4) the Morisky Medication Adherence Scale-4 items (MMAS-4); and (5) the Treatment Burden Questionnaire (TBQ). Reliability was assessed by a test-retest method. RESULTS: A total of 243 patients taking 961 drugs were recruited in 2014. We found good agreement between adherence measured by our tool and drug diaries (intraclass correlation coefficient (ICC) 0.69, 95% CI 0.34 to 0.91) and a linear relationship between measurement with our tool and (1) the Lu instrument (p<0.01); (2) 2 items of the AE (perceived need for medication (p<0.01) and concerns about medication (p<0.01)); (3) patients' adherence assessed by their physicians (p<0.01); (4) the MMAS-4 (p<0.01) and (5) the TBQ (p<0.01). Reliability of the retest was good (ICC 0.67, 95% CI 0.42 to 0.85). CONCLUSIONS: We developed an instrument with acceptable validity and reliability to assess adherence for each drug taken by patients, usable in hospital and primary care settings.