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.

Prevalence of dysmenorrhea in adolescents in France: Results of a large cross-sectional study.

BACKGROUNDS: Dysmenorrhea is the most common gynecological complaint in young women but is overlooked by recent studies. Our objective was to evaluate the prevalence of dysmenorrhea in adolescents in France and its impact on daily living. METHODS: It was a cross-sectional study conducted between April-May 2019, in eight randomly selected high schools in France. Participants were randomly selected post-menarche girl pupils 15-19 years who completed a 50-item questionnaire. Dysmenorrhea severity was assessed with the Numerical Rating Scale (NRS) and Verbal Multidimensional Scoring System Scale (VMSS). RESULTS: Questionnaires from 953 girls were analyzed (mean age: 16.9 years). The prevalence of dysmenorrhea was 92.9% with 8.9% describing their pain as severe. Impact on quality of life was significant: 43.3% reported school absences because of dysmenorrhea, 74.9% difficulties in attending classes and 77.2% difficulties in sports activities. Risk factors of severe dysmenorrhea in multivariate analysis were heavy menstrual bleeding (OR 2.02, 95%CI [1.12; 3.63] p = 0.0192), early menarche (OR 0.68, 95%CI [0.57; 0.81] p<0.0001), chronic pelvic pain (OR 2.60, 95%CI [1.10; 6.11] p = 0.0274), BMI (BMI<18, OR 1.94, 95%CI [1.03; 3.66] p = 0.0335). Of the 50.4% who had consulted a physician, 45.4% had seen a general practitioner. Among the girls who had not consulted, 55.1% reported that menstruation was a "woman's burden". CONCLUSIONS: Dysmenorrhea is highly prevalent in adolescents in France and has a real impact on daily living with social repercussions. As such, it should be treated as a public health problem with educational and information campaigns targeting the girls themselves, their families and healthcare professionals.