Interrater reliability in neurology objective structured clinical examination across specialties.

PURPOSE: To assess interrater reliability and examiners' characteristics, especially specialty, associated with scoring of neurology objective structured clinical examination (OSCE). MATERIAL AND METHODS: During a neurology mock OSCE, five randomly chosen students volunteers were filmed while performing 1 of the 5 stations. Video recordings were scored by physicians from the Lyon and Clermont-Ferrand university teaching hospitals to assess students performance using both a checklist scoring and a global rating scale. Interrater reliability between examiners were assessed using intraclass coefficient correlation. Multivariable linear regression models including video recording as random effect dependent variable were performed to detect factors associated with scoring. RESULTS: Thirty examiners including 15 (50%) neurologists participated. The intraclass correlation coefficient of checklist scores and global ratings between examiners were 0.71 (CI95% [0.45-0.95]) and 0.54 (CI95% [0.28-0.91]), respectively. In multivariable analyses, no factor was associated with checklist scores, while male gender of examiner was associated with lower global rating (ß coefficient = -0.37; CI 95% [-0.62-0.11]). CONCLUSIONS: Our study demonstrated through a video-based scoring method that agreement among examiners was good using checklist scoring while moderate using global rating scale in neurology OSCE. Examiner's specialty did not affect scoring whereas gender was associated with global rating scale.

Determinants of adherence and consequences of the transition from adolescence to adulthood among young people with severe haemophilia (TRANSHEMO): A multicentric French national observational cross-sectional study based on the FranceCoag registry.

INTRODUCTION: It is necessary to gain insights into adherence to healthcare in people with severe haemophilia (PwSH), especially during the transition from paediatric to adult care, which is an important phase in lives of young people with childhood chronic disease. This adherence can be considered as a marker of successful transition. OBJECTIVES: The main objective of the quantitative phase of the TRANSHEMO project was to compare the adherence to healthcare between adolescents and young adults (YAs) with severe haemophilia. The secondary objective was to identify the determinants (facilitators and barriers) of this adherence and associations between these determinants. METHODS: A multicentre, observational, cross-sectional study was conducted in 2017-2019 on PwSH aged between 14 and 17 years (adolescents) or between 20 and 29 years (YAs), included in the FranceCoag registry and having completed the questionnaires. The adherence to healthcare (treatment regimens and clinical follow-up) was compared between adolescents and YAs using the chi-squared test. The determinants of this adherence were analysed by structural equation modelling. RESULTS: There were 277 participants, 107 adolescents, and 170 YAs. The rate of adolescents adhering to healthcare was 82.2%, while the rate of YAs was 61.2% (p < .001). The barriers to the adherence to healthcare were being YA, having repeated at least one school grade and presenting mental health concerns. CONCLUSION: Adolescents had better adherence to healthcare than YAs. According to the determinants enlightened in this project, targeted supportive strategies and adapted therapeutic education programs can be developed for young PwSH to facilitate their adherence to healthcare.

Toward an Interdisciplinary Approach to Constructing Care Delivery Pathways From Electronic Health Care Databases to Support Integrated Care in Chronic Conditions: Systematic Review of Quantification and Visualization Methods.

BACKGROUND: Electronic health care databases are increasingly used for informing clinical decision-making. In long-term care, linking and accessing information on health care delivered by different providers could improve coordination and health outcomes. Several methods for quantifying and visualizing this information into data-driven care delivery pathways (CDPs) have been proposed. To be integrated effectively and sustainably into routine care, these methods need to meet a range of prerequisites covering 3 broad domains: clinical, technological, and behavioral. Although advances have been made, development to date lacks a comprehensive interdisciplinary approach. As the field expands, it would benefit from developing common standards of development and reporting that integrate clinical, technological, and behavioral aspects. OBJECTIVE: We aimed to describe the content and development of long-term CDP quantification and visualization methods and to propose recommendations for future work. METHODS: We conducted a systematic review following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) recommendations. We searched peer-reviewed publications in English and reported the CDP methods by using the following data in the included studies: long-term care data and extracted data on clinical information and aims, technological development and characteristics, and user behaviors. The data are summarized in tables and presented narratively. RESULTS: Of the 2921 records identified, 14 studies were included, of which 13 (93%) were descriptive reports and 1 (7%) was a validation study. Clinical aims focused primarily on treatment decision-making (n=6, 43%) and care coordination (n=7, 50%). Technological development followed a similar process from scope definition to tool validation, with various levels of detail in reporting. User behaviors (n=3, 21%) referred to accessing CDPs, planning care, adjusting treatment, or supporting adherence. CONCLUSIONS: The use of electronic health care databases for quantifying and visualizing CDPs in long-term care is an emerging field. Detailed and standardized reporting of clinical and technological aspects is needed. Early consideration of how CDPs would be used, validated, and implemented in clinical practice would likely facilitate further development and adoption. TRIAL REGISTRATION: PROSPERO CRD42019140494; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=140494. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2019-033573.

[Learning motivational interviewing to better support patient medication adherence]. / Se former à l'entretien motivationnel pour mieux soutenir l'adhésion thérapeutique des patients.

Motivational interviewing (MI), developed in the 1980s, demonstrated efficacy in helping patients to change their health behavior, and more recently in supporting patient therapeutic adherence. However, the training in patient therapeutic adherence support is poor and unequally distributed within the initial and continuing training of health professionals. To cope, an interprofessional continuing training was designed by health professionals and researchers, aiming at acquiring fundamental knowledge in therapeutic adherence and MI skills. The results of the first training session should encourage health professionals to train, and decision-makers to promote wider dissemination of this training.

Depuis son développement dans les années 1980, l'entretien motivationnel (EM) s'est avéré efficace pour accompagner les patients à modifier leur comportement en santé, et plus récemment dans le soutien de leur adhésion thérapeutique. Cependant, la formation au soutien de l'adhésion thérapeutique est pauvre et inégalement répartie au sein de la formation initiale et continue des professionnels de santé. Face à ce constat, une formation continue interprofessionnelle a été conçue par des professionnels de santé et chercheur-e-s, visant à l'acquisition des connaissances fondamentales en adhésion thérapeutique et des compétences en EM. Les résultats objectivés par la première session de formation devraient inciter les professionnels de santé à se former et les décideurs à favoriser une diffusion plus large de ce type de formation.

Temporal Trend of Transient Ischemic Attack Management over a 10-Year Period: Data from the Rhône County, France.

BACKGROUND: Timely recognition and management of transient ischemic attack (TIA) offer the greatest opportunity to prevent subsequent stroke. But variability of TIA management quality exists across hospitals. Under the impetus of national plans, measures were adopted to improve TIA management, including a structured local pathway. Our objective was to compare TIA management between two periods over 10 years, before and after the implementation of these measures. METHODS: A before-and-after study was conducted with two identical population-based cohort studies in 2006-2007 (AVC69) and 2015-2016 (STROKE69) including all patients with TIA diagnosis over a 7-month period in six public and private hospitals in the Rhône county in France. The primary outcome was the adequate TIA management defined as brain and vessel imaging within 24 h of admission and the prescription of antithrombotic treatment at discharge. RESULTS: We identified 109 patients TIA patients in 2006-2007, and 458 over the same period in 2015-2016. A higher proportion of patients were adequately managed in 2015-2016 compared to 2006-2007 (14/96 [15%] in 2006-2007 vs. 306/452 [68%] in 2015-2016, p < 0.001). This difference was mainly driven by a marked increase of vessel imaging performed within 24 h of admission, most often by computed tomography angiography. Furthermore, patients called more often emergency medical dispatch before admission, were admitted with a shorter delay after symptom onset, and were more likely discharged to home in 2015-2016 compared to 2006-2007. CONCLUSION: Our study demonstrated an increasing rate of adequate TIA management, mainly driven by a marked increase of vessel imaging within 24 h of admission, over a 10-year period in the Rhône county in France.

Palliative and high-intensity end-of-life care in schizophrenia patients with lung cancer: results from a French national population-based study.

Schizophrenia is marked by inequities in cancer treatment and associated with high smoking rates. Lung cancer patients with schizophrenia may thus be at risk of receiving poorer end-of-life care compared to those without mental disorder. The objective was to compare end-of-life care delivered to patients with schizophrenia and lung cancer with patients without severe mental disorder. This population-based cohort study included all patients aged 15 and older who died from their terminal lung cancer in hospital in France (2014-2016). Schizophrenia patients and controls without severe mental disorder were selected and indicators of palliative care and high-intensity end-of-life care were compared. Multivariable generalized log-linear models were performed, adjusted for sex, age, year of death, social deprivation, time between cancer diagnosis and death, metastases, comorbidity, smoking addiction and hospital category. The analysis included 633 schizophrenia patients and 66,469 controls. The schizophrenia patients died 6 years earlier, had almost twice more frequently smoking addiction (38.1%), had more frequently chronic pulmonary disease (32.5%) and a shorter duration from cancer diagnosis to death. In multivariate analysis, they were found to have more and earlier palliative care (adjusted Odds Ratio 1.27 [1.03;1.56]; p = 0.04), and less high-intensity end-of-life care (e.g., chemotherapy 0.53 [0.41;0.70]; p < 0.0001; surgery 0.73 [0.59;0.90]; p < 0.01) than controls. Although the use and/or continuation of high-intensity end-of-life care is less important in schizophrenia patients with lung cancer, some findings suggest a loss of chance. Future studies should explore the expectations of patients with schizophrenia and lung cancer to define the optimal end-of-life care.

Early Detection of Patients at Risk of Developing a Post-Traumatic Stress Disorder After an ICU Stay.

OBJECTIVES: To evaluate the diagnostic accuracy of the Impact Event Scale-Revisited assessed following ICU discharge to predict the emergence of post-traumatic stress disorder symptoms at 3 months. DESIGN: Prospective cohort study. SETTING: Three medical or surgical ICU of a French university hospital (Lyon, France). PATIENTS: Patients greater than or equal to 18 years old, leaving ICU after greater than or equal to 2 nights of stay, between September 2017 and April 2018. INTERVENTIONS: Patients completed the Impact Event Scale-Revisited and the Peritraumatic Dissociative Experiences Questionnaire within 8 days after ICU discharge and the Impact Event Scale-Revisited again at 3 months by phone. Patients having an Impact Event Scale-Revisited greater than or equal to 35 at 3 months were considered as having post-traumatic stress disorder symptoms. MEASUREMENTS AND MAIN RESULTS: Among the 208 patients screened, 174 were included and 145 reassessed by phone at 3 months. Among the patients included at baseline, 43% presented symptoms of acute stress. At 3 months, 13% had an Impact Event Scale-Revisited greater than or equal to 35 and 17% had a score between 12 and 34. Regarding the performance of the Impact Event Scale-Revisited performed within 8 days after the ICU discharge to predict post-traumatic stress disorder symptoms at 3 months, the area under the curve was 0.90 (95% CI, 0.80-0.99), and an Impact Event Scale-Revisited greater than or equal to 12 had a sensitivity of 90%, a specificity of 71%, a positive predictive value of 32%, and a negative predictive value of 98%. History of anxiety disorder odds ratio = 3.7 (95% CI, 1.24-11.05; p = 0.02) and Impact Event Scale-Revisited greater than or equal to 12 odds ratio = 16.57 (95% CI, 3.59-76.46; p < 0.001) were identified as risk factors for post-traumatic stress disorder symptoms. CONCLUSIONS: Impact Event Scale-Revisited assessed at ICU discharge has a good ability for the detection of patients at risk of developing post-traumatic stress disorder symptoms. Patients with history of anxiety disorder and those presenting acute stress symptoms at ICU discharge are more at risk to develop post-traumatic stress disorder symptoms.

Choice of Initial Brain Imaging in Patients with Suspected Acute Stroke: STROKE69, a Population-Based Study.

BACKGROUND: In patients with suspected stroke, brain imaging is recommended in the acute phase for appropriate management and treatment. Both computed tomography (CT) and magnetic resonance imaging (MRI) are considered reasonable choices for initial brain imaging. When both techniques are available, choosing one or the other might be associated with specific factors related either to patients, stroke symptoms, and severity or management organization. METHODS: The study was performed within the STROKE 69 database, a population-based cohort of all adult patients with suspected stroke admitted in one of the emergency departments (ED), primary stroke center, or stroke center of the Rhône County, from November 2015 to December 2016. Patients were included if they were admitted within 24 h following either symptom onset or last known normal. To identify factors potentially associated with the choice of initial brain imaging, a multivariate logistic regression was performed. RESULTS: Among the 3,244 patients with suspected stroke enrolled in the STROKE69 cohort, 3,107 (95.8%) underwent brain imaging within the first 24 h after admission. Among those 74.6% underwent CT as initial imaging while 25.4% had an MRI. In multivariate analyses, several factors were associated with a lower probability of having an MRI as initial brain imaging versus CT. These were either patient characteristics: older age (>80 years old, OR 0.39 [95% CI 0.28-0.54]), preexisting disability (OR 0.55 [95% CI 0.36-0.84]), use of anticoagulants (OR 0.52 [95% CI 0.33-0.81]), stroke characteristics: stroke of unknown onset (OR 0.42 [95% CI 0.31-0.58]) or factors associated with overall management: onset-to-door time (>6 h, OR 0.38 [95% CI 0.23-0.60]), initial admission to ED (OR 0.02 [95% CI 0.02-0.04]) or intensive care unit (OR 0.01 [95% CI 0.001-0.08]), personal transport (OR 0.66 [95% CI 0.45-0.96]), and admission during working hours (OR 0.65 [95% CI 0.51-0.84]). CONCLUSIONS: Besides CT or MRI availability, a number of other parameters could influence the choice of first imaging in case of stroke suspicion. These are related to patient characteristics, type of stroke symptoms, and type of organization.

Myocardial infarction: Economic, health, and social impacts on informal caregivers.

OBJECTIVES: The aim of the study was to measure the economic impact of informal care (IC) on caregivers assisting myocardial infarction (MI) survivors in France. Health and social impacts were also described. METHODS: Data from the prospective 2008 Health and Disabilities Households Survey (Enquête Handicap-Santé), carried out among the French general population, were used to obtain information about patients with MI and their informal caregivers. To estimate the approximate monetary value of IC, three methods were used: the proxy good method, opportunity cost method (OCM), and contingent valuation method (CVM). A multivariate analysis was performed to determine the associations of the IC duration and the existence of professional care with the health indicators stated by caregivers. RESULTS: The analysis included data from 147 caregivers. The mean value of IC ranged from €9,679 per year using the CVM to €11,288 per year using the OCM (p > .05). The mean willingness to pay for an additional hour of IC was €10.9 (SD = 8.3). A total of 46.2 percent of caregivers reported that IC negatively affected theirs physical condition, and 46.3 percent reported that it negatively affected their psychological health. In addition, 40.1 percent declared that caregiving activity made them anxious and 38.8 percent stated they felt alone. Associations were identified between the duration of IC and feeling the need to be replaced, feeling alone and making sacrifices (p < .05). CONCLUSIONS: Informal caregiver burden may be recognized in health technology assessment in order not to underestimate the cost of strategies and to facilitate the comparability of cost-effectiveness outcomes between studies.

Identification of biopSychoSocial factors predictive of post-traUmatic stress disorder in patients admitted to the Emergency department after a trauma (ISSUE): protocol for a multicenter prospective study.

BACKGROUND: Traumatic exposure is a frequent issue in patients visiting emergency departments (EDs). Some patients will subsequently develop post-traumatic stress disorder (PTSD) while other will not. The problem is under-diagnosed in EDs and no standardized management is provided to prevent PTSD. Most studies focused on a particular group of trauma whereas we need a global approach to further develop interventions for detecting and treating patients at high risk. We aim to assess the prevalence of traumatic exposure and situation at high risk of further PTSD and identify pre and peri-traumatic biopsychosocial factors predisposing individuals to PTSD in the general context of EDs. METHODS: This comprehensive multicenter study will have two steps. The first step will be a cross-sectional study on moderate and high risk of PTSD prevalence among EDs visitors with a recent history of trauma. All patients aged 18-70 years, presenting with a recent history of trauma (< 1 month) in one of the six EDs in the Auvergne-Rhône-Alpes region (≈1/10° of the French population) will be included over a 1-month period and approximately 1500 subjects are expected in this cross-sectional step. The risk of PTSD will be assessed using the Impact of Event Scale Revised (IES-R). Self-administered questionnaires will be used to measure acute stress (IES-R), and a number of potential bio-psycho-social risk factors. Demographic and physical health-related data will be collected from medical file. Second step will be a prospective cohort study within a sub-sample of 400 patients enrolled in step 1, randomly selected with stratification on sex, age, ED, and IES-R score. At 3 months, PTSD will be defined by a ≥ 33 score at PTSD Check List for DSM-5 (PCL-5) through a telephone interview. We will evaluate definite PTSD biopsychosocial predictive factors using a multivariate logistic regression model and describe evolution of PTSD at 3 months. DISCUSSION: This is the first study to assess PTSD predictors prospectively with a biopsychosocial approach within a cohort representative of EDs visitors. The results will inform the development of dedicated interventions to decrease the risk of subsequent PTSD. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03615014 ; ISSUE protocol 2nd version was approved on 07/08/2018.

Secondary Prevention Three and Six Years after Stroke Using the French National Insurance Healthcare System Database.

BACKGROUND: Secondary prevention is inadequate in the first 2 years after stroke but what happens after that is less documented. The aim of this study was to assess the use and the adherence to preventive drugs 3 and 6 years after experiencing a transient ischemic attack (TIA) or an ischemic stroke (IS). METHODS: The population study was from the AVC69 cohort (IS or TIA admitted in an emergency or stroke unit in the Rhône area, France, for an IS or a TIA during a 7-month period). Medication use was defined as ≥1 purchase during the studied year and adherence as Continuous Measure of Medication Acquisition ≥0.8 using the French medical insurance health care funding database. RESULTS: The study population consisted of 210 patients at 3 years and 163 patients at 6 years. Medication use at 3 and 6 years was, respectively, 80.9 and 79.8% for antithrombotics, 69.1 and 66.3% for antihypertensives, 60.5 and 55.2% for statins and 48.6 and 46.6% for optimal treatment defined as the treatment achieved by the use of the 3 drugs. Adherence to each class was good at 3 years and tends to decrease at 6 years. CONCLUSIONS: More than one patient out of 2 do not use the optimal preventive treatment.

Implementing Indicators and Trajectories of Return to Work After Breast Cancer Diagnosis: A Mixed-Methods Study Using the French National Healthcare Insurance Database and Stakeholder Consultation.

PURPOSE: Return to work (RTW) is important for quality of life after breast cancer but its analysis at the population-level remains limited in France. This study aimed to implement Electronic Healthcare Data (EHD)-based indicators and trajectories to measure RTW after breast cancer diagnosis, and to examine stakeholders' perspectives regarding these indicators. METHODS: We followed a mixed-methods approach that consisted of (i) implementing RTW indicators and identifying clusters of trajectories using state sequence analysis with data from a representative sample of the French National Health Data System and (ii) exploring, through qualitative focus group and interviews, stakeholders' perceptions on the interpretation, limitations, and utility of these indicators. RESULTS: We extracted data from 317 women aged 25-55 years with a first diagnosis of early-stage breast cancer. The median number of sickness absence periods was 2 for a total of 434 days during the 3-year follow-up, and the median time to sustainable RTW was 240 days. Three clusters of RTW trajectories were identified: "early RTW" (49.5% of the population), "RTW after partial resumption" (37.5%) and "continuous compensation" (12.9%). Feedback from stakeholders highlighted the multi-factorial nature of RTW and underscored the added value of EHD for studying RTW, despite certain limitations. CONCLUSIONS: We demonstrated the feasibility of calculating RTW indicators and identifying trajectories using the French National Health Data System. These indicators can serve as outcome measures in RTW promotion and provide a basis for designing targeted interventions for breast cancer survivors.

Motivational interviewing to support medication adherence in older patients: Barriers and facilitators for implementing in hospital setting according to healthcare professionals.

OBJECTIVE: The aim of this study was to understand through Healthcare professionals' (HCPs) opinions the barriers and facilitators to implement MI in older hospitalized patients. METHODS: A qualitative study with semi-structured interviews was performed among 23 HCPs involved in the medication management of older hospitalized patients (geriatricians, nurses, psychologists and pharmacists). A thematic analysis was conducted using a deductive approach through the Theoretical Domain Framework (TDF), and an inductive approach. RESULTS: The thematic analysis reported 25 factors influencing MI implementation, mapped into 8 TDF themes, and including 13 facilitators, 8 barriers, and 4 both. The main factors identified were: 'cognitive and sensory disorders' (barrier), 'having dedicated time and HCPs' (facilitator and barrier), and the 'HCP's awareness about MI' (facilitator). Ten factors were identified as specific to the older population. CONCLUSIONS: Implementing MI in a hospital setting with older patients presented both barriers and facilitators. PRACTICE IMPLICATIONS: To ensure successful MI implementation, it is important to take into account the older patients' context, the hospital environment, and the HCPs-related factors.

Health care resource utilization preceding death or lung transplantation in people with cystic fibrosis: HCRU before transplant or death in cystic fibrosis.

BACKGROUND: We studied the health care resource utilization (HCRU) and associated costs in the year preceding LT in pwCF or death without LT, and we estimated the overall cost of LT. METHODS: We performed a linkage between 2006 and 2017 data from the French CF Registry (FCFR) and the French health claims database (Système National des Données de Santé; SNDS). The HCRU and associated costs were described the year before LT or before death without LT, and two years after LT. RESULTS: Among the 7,671 patients included in the FCFR, 6,187 patients (80.7 %) were successfully matched to patients in the SNDS (males (m): 51.9 %, mean±SD age at the end of follow-up: 24.6 ± 13.6). Overall, 166 patients died without LT (m: 47.6 %, age at death: 30.4 ± 14.5) and 767 patients with primary LT (m: 48.2 %, age at transplantation: 28.0 ± 9.1) were identified. HCRU was lower among patients who died without receiving LT, with marked differences in the cost of hospital stays. The mean total cost per patient was €66,759 ± 38,249 in the year before death, €149,374 ± 62,678 in the year preceding LT, €63,919 ± 35,399 in the first year following LT, and €42,813 ± 39,967 in the second year of follow-up. CONCLUSION: Our results indicate that HCRU was two times lower in the year before death in non-transplant pwCF than in the year before LT, which may reflect inappropriate care of CF in patients who died without receiving LT. It also shows the cost associated with LT.

Factors associated with post-stroke social participation: A quantitative study based on the ICF framework.

BACKGROUND: Post-stroke social participation is a major determinant of quality of life and life satisfaction. However, few data relating to participation determinants are available, especially the influence of psychological factors and factors related to the living environment. OBJECTIVES: This study investigated determinants of post-stroke social participation within the International Classification of Functioning, Disability and Health framework. METHODS: We contacted people with stroke who had been hospitalized in the Rhône County, included in a previous cohort study, were aged ≥18 years and were not institutionalized. The primary outcome was social participation measured with the Stroke Impact Scale (SIS) 2.0. We performed multiple hierarchical linear regressions to test the following predictors: clinical factors (stroke-related variables, limitations in Activities of Daily Living [ADL]/Instrumental ADL), personal factors (sociodemographic factors, coping strategies) and environmental factors (satisfaction with social relationships and living environment). RESULTS: Among the 352 participants, 63% were men, and mean age was 68.7(SD 14.5) years. In the last multivariate model, variables associated with higher levels of social participation were the use of the positive thinking coping strategy (B (SD)=1.17(0.52), p = 0.03), higher perceived satisfaction with the living environment (B (SD)=0.17(0.07), p = 0.03) and fewer perceived activity limitations (B (SD)=0.55 (0.06), p < 0.001). Conversely, the seeking social support coping style (B (SD)= -1.98 (0.60), p = 0.001), and a higher number of stroke-related sequelae (B (SD)= -1.93(0.53), p = 0.001) were associated with lower social participation. CONCLUSIONS: The identification of potentially modifiable personal and environmental factors that influence social participation provides elements to strengthen existing rehabilitation programs and opens the way for possible psychosocial interventions.

A Participatory Approach Involving Patients with Cystic Fibrosis and Healthcare Professionals for the Co-Design of an Adherence-Enhancing Intervention Toolkit.

Purpose: Cystic fibrosis (CF) is an inherited life-shortening disease involving a significant treatment burden. Few interventions have been proven effective in improving adherence, and of these fewer have been adopted for implementation. Patient participation in research is increasingly desired in developing relevant health care services. A participatory approach was implemented in an adult CF center to co-design an adherence-enhancing intervention toolkit. We aimed to report on the participatory process and the results regarding the co-designed intervention. Patients and Methods: Two focus group sessions and four working sessions were conducted at 4-week intervals with three healthcare professionals (HCP; physician, nurse, physiotherapist), eight patients, and two researchers (sociologist, public health pharmacist). The two initial focus group sessions were dedicated to the collection of narratives about CF treatment experiences to identify drivers of adherence. The next four working sessions were dedicated to the reflection on solutions that could alleviate the difficulties identified and be used in current clinical practice. The researchers observed during all sessions the interactions between participants, group dynamics, and process of implementation of the collective reflection. Results: The process facilitated an active participation of patients and HCP, who contributed equally to the intervention development. The co-design adherence-enhancing intervention toolkit consisted in a self-questionnaire to be completed by patients before the medical consultation and used as a communication support during the consultation, plus a toolkit of solutions to be proposed by the HCP for each barrier identified by patients, and to be followed up during the next consultation. Conclusion: This study demonstrated that a participatory approach involving CF patients and HCP lead to the development of an adherence-enhancing intervention toolkit, using a 6-session format; the benefits of the co-designed intervention on the medication adherence have yet to be tested in a multicenter, open-label study in 3 centers in France.

Real-world data and evidence in health technology assessment: When are they complementary, substitutes, or the only sources of data compared to clinical trials?

Within the life-cycle assessment of health technologies, real-world data (RWD) have until now been of secondary importance to clinical trial data. The availability of massive, better quality RWD, particularly with the emergence of connected devices, the improvement of methods for characterizing populations, make it possible to have a better insight into the effects of treatment, sometimes on a national scale the importance of RWD is likely to progress in the eyes of health technology assessors, going from being traditionally complementary to possibly replacing clinical trial data. This is the fundamental question that the round table, involving experts from the academic and/or hospital, institutional, and industrial worlds, set out to answer. This work served first to establish the current role of RWD in health technology assessment, by distinguishing the main purposes of RWD, the timing of the evaluation in relation to the life cycle of the technology, and then according to the party commissioning or receiving the outcomes of RWD-based studies. Secondly, the round table proposed six general recommendations for more intensive and decisive use of RWD in the assessment and decision-making process.

Motivational interviewing to support medication adherence in adults with chronic conditions: Systematic review of randomized controlled trials.

OBJECTIVES: To systematically review published randomized controlled trials (RCTs) assessing the efficacy of MI to support medication adherence in adults with chronic conditions. METHODS: A systematic review (PROSPERO-CRD42020025374) was performed by searching in Pubmed/MEDLINE, PsycINFO, The Cochrane Library and Web of Science. Studies were included for the following: RCTs assessing the impact of MI on medication adherence among adults with chronic diseases. Two reviewers conducted independent screening of records and full-text articles published until July 2020. Quality was assessed with the Risk of Bias 2 tool for RCTs. RESULTS: From 1262 records identified, 54 RCTs were included. The MI interventions were delivered alone or in combination with other interventions, and varied in mode of delivery (e.g. face-to-face, phone), exposure level (duration, number of sessions), and provider characteristics (profession, training). Most interventions were developed in infectious diseases (n = 16), cardiology (n = 14), psychiatry (n = 8), and endocrinology (n = 7). Medication adherence showed significant improvement in 23 RCTs, and other clinical outcomes were improved in 19 RCTs (e.g. risky behaviors, disease symptoms). CONCLUSIONS: MI is an approach to medication adherence support with an increasing evidence base in several clinical domains and further potential for adaptation to different settings. PRACTICE IMPLICATIONS: In further studies, particular attention should focus on methodological issues such as the populations of patients to include - patients with suboptimal adherence, the evaluation of fidelity to the MI spirit and components, and a sound measurement of medication adherence and clinical outcomes.

Temporal trends in healthcare resource use and associated costs of patients with cystic fibrosis.

BACKGROUND: Better insights into the natural course of cystic fibrosis (CF) have led to treatment approaches that have improved pulmonary health and increased the life expectancy of affected individuals. This study evaluated how the combination of modified demographics and changes in CF management impacted resource consumption and the cost of care. METHODS: Medical records of CF patients from 2006 to 2016 in the French CF Registry were linked to their corresponding claims data (SNDS). Medications, medical visits, procedures, hospitalisations, and indirect costs were annualized by calendar year from 2006 to 2017. RESULTS: Of the 7,671 patients included in the French CF Registry, 6,187 patients (80.7%) were linked to the SNDS (51.9% male, mean age = 24.7 years). The average cost per patient was €14,174 in 2006, €21,920 in 2011 and €44,585 in 2017. Costs associated with hospital stays increased from €3,843 per patient in 2006 to €6,741 in 2017. In 2017, the mean cost per CF patient was allocated as follows: 72% for medications (of which 51% for modulator therapies), 15% for hospital stays, 7% for medical visits, 3% for indirect costs, 2% for medical devices, 1% for outpatient medical procedures. CONCLUSION: There was a strong increase in the mean annual cost per CF patient between 2006 and 2017, mostly due to the cost of therapy after the introduction of cystic fibrosis transmembrane conductance regulator (CFTR) modulators. The combination of an increase in the number of CF patients - particularly adult patients - and an increase in the annual cost per patient led to a substantial increase in the total cost of CF disease care for the health systems.