Evaluation of adherence to antipsychotics: A real-world data study using four different dosing assumptions.

AIMS: This study aimed to assess the frequency of dosing inconsistencies in prescription data and the effect of four dosing assumption strategies on adherence estimates for antipsychotic treatment. METHODS: A retrospective cohort, which linked prescription and dispensing data of adult patients with ≥1 antipsychotic prescription between 2015-2016 and followed up until 2019, in Catalonia (Spain). Four strategies were proposed for selecting the recommended dosing in overlapping prescription periods for the same patient and antipsychotic drug: (i) the minimum dosing prescribed; (ii) the dose corresponding to the latest prescription issued; (iii) the highest dosing prescribed; and (iv) all doses included in the overlapped period. For each strategy, one treatment episode per patient was selected, and the Continuous Medication Availability measure was used to assess adherence. Descriptive statistics were used to describe results by strategy. RESULTS: Of the 277 324 prescriptions included, 76% overlapped with other prescriptions (40% with different recommended dosing instructions). The number and characteristics of patients and treatment episodes (18 292, 18 303, 18 339 and 18 536, respectively per strategy) were similar across strategies. Mean adherence was similar between strategies, ranging from 57 to 60%. However, the proportion of patients with adherence ≥90% was lower when selecting all doses (28%) compared with the other strategies (35%). CONCLUSION: Despite the high prevalence of overlapping prescriptions, the strategies proposed did not show a major effect on the adherence estimates for antipsychotic treatment. Taking into consideration the particularities of antipsychotic prescription practices, selecting the highest dose in the overlapped period seemed to provide a more accurate adherence estimate.

Patient Satisfaction and Willingness to Continue with Telemental Health Care During and After the Early Period of SARS-CoV-2 Pandemic: A User Survey.

Objective: The SARS-CoV-2 pandemic and related lockdown periods generated an increase in the use of virtual care for mental health (MH). This study aimed to assess patient satisfaction with Telemental Health services (TMH) during first lockdown and factors related to their willingness to continue using this service. Methods: We conducted a cross-sectional survey of 364 MH outpatients from 9 centers in the Barcelona region (Spain), who received TMH between April 20 and May 22, 2020. We assessed sociodemographic and clinical characteristics, prior experience, and familiarity with technologies and satisfaction with TMH. Willingness to receive TMH after the lockdown was measured separately for telephone and videoconferencing. We performed descriptive statistics and bivariate and multivariate regression models to predict TMH willingness. Results: From 450 patients contacted, 364 were interviewed. Satisfaction with TMH was high (mean 9.24, standard deviation 0.07); 2.47% preferred only TMH visits after lockdown, 23.08% preferred mostly TMH visits, 50.82% accepted some TMH visits, and 23.63% would prefer in-person consultations. Female patients and those having received TMH during lockdown showed higher odds of willingness to receive TMH in the future, while patients unfamiliar with technologies showed lower odds. Concerning TMH through telephone, willingness was more likely in patients living with more persons. Videoconferencing willingness was more likely for people living with depression. Conclusions: TMH was well accepted during the first lockdown and patients were willing to maintain it after lockdown. Low familiarity with new technologies is an important barrier to TMH willingness, which needs to be addressed for appropriate implementation going forward.

Methodological considerations on estimating medication adherence from self-report, electronic monitoring and electronic healthcare databases using the TEOS framework.

AIMS: Measuring adherence to medication is complex due to the diversity of contexts in which medications are prescribed, dispensed and used. The Timelines-Events-Objectives-Sources (TEOS) framework outlined a process to operationalize adherence. We aimed to develop practical recommendations for quantification of medication adherence using self-report (SR), electronic monitoring (EM) and electronic healthcare databases (EHD) consistent with the TEOS framework for adherence operationalization. METHODS: An adherence methodology working group of the International Society for Medication Adherence (ESPACOMP) analysed implications of the process of medication adherence for all data sources and discussed considerations specific to SR, EM and EHD regarding the information available on the prescribing, dispensing, recommended and actual use timelines, the four events relevant for distinguishing the adherence phases, the study objectives commonly addressed with each type of data, and the potential sources of measurement error and quality criteria applicable. RESULTS: Four key implications for medication adherence measurement are common to all data sources: adherence is a comparison between two series of events (recommended and actual use); it refers to one or more specific medication(s); it applies to regular repeated events coinciding with known recommended dosing; and it requires separate measurement of the three adherence phases for a complete picture of patients' adherence. We propose recommendations deriving from these statements, and aspects to be considered in study design when measuring adherence with SR, EM and EHD using the TEOS framework. CONCLUSION: The quality of medication adherence estimates is the result of several design choices that may optimize the data available.

[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.

Considering health literacy in cardiovascular disease management: a qualitative study on healthcare professionals' and patients' perspectives.

BACKGROUND: Implementing practices adapted to patient health literacy (HL) is a promising avenue for improving their outcomes in the context of cardiovascular diseases (CVD). The health communication skills of healthcare professionals (HCPs) and the quality of information provided are essential for low-HL patients. We aimed to explore HCP knowledge about HL, patients' and HCPs' views on current practices regarding low-HL patients, and facilitators and barriers to adapting communication to patients' HL level, in order to prepare the implementation of a complex intervention dedicated to improve CVD management for low-HL patients. METHODS: We conducted face-to-face semi-structured interviews with HCPs practicing in cardiology units and patients hospitalized for CVD. The study design and analysis were based on the Theory of Planned Behavior for HCPs and on the framework of Health Literacy and Health Action for patients. Deductive and inductive thematic analysis were used. Barriers and facilitators were structured into an Ishikawa fishbone diagram and implementation strategies were selected to address resulting themes from the Expert Recommendations for Implementing Change (ERIC). RESULTS: Fifteen patients and 14 HCPs were interviewed. HCPs had partial knowledge of HL dimensions. Perceptions of HCPs and patients were not congruent regarding HCP-patient interactions and information provided by hospital and community HCPs. HCPs perceived they lacked validated tools and skills, and declared they adapted spontaneously their communication when interacting with low-HL patients. Patients expressed unmet needs regarding communication during hospital discharge and at return to home. CONCLUSION: To implement HL-tailored practices in this setting, our results suggest that several implementation strategies will be valuable at individual (engaging patients and their family), interactional (educating and training of HCPs about HL), and organizational levels (creating a multidisciplinary HCP interest group dedicated to HL). TRIAL REGISTRATION: ClinicalTrials.gov, (NCT number) NCT03949309, May 10, 2019.

Barriers and Facilitators to Participation in Health Screening: an Umbrella Review Across Conditions.

Screening is an essential prevention practice for a number of health conditions. However, screening coverage remains generally low. Studies that investigate determinants of screening participation are becoming more common, but oftentimes investigate screening for health conditions in an individualized rather than integrated fashion. In routine clinical practice, however, healthcare professionals are often confronted with situations in which several screening procedures are recommended for the same patient. The consideration of their common determinants may support a more integrated screening approach. The objectives of this umbrella review were therefore to examine: 1) the determinants (barriers and facilitators) that have been identified in relation to recommended health screening procedures; and 2) the modifiable determinants (in primary care) common across health conditions or specific to individual procedures. Results were presented through a narrative synthesis. PubMed, PsycInfo and Cochrane were searched up to January 2022. Systematic reviews reporting determinants of participation in health screening procedures with grade A or B recommendation according to the US Preventive Services Task Force were included. A total of 85 systematic reviews were included, most which contained both qualitative and quantitative studies on determinants that describe individual factors (961 occurrences), social factors (113 occurrences, healthcare professional factors (149 occurrences), health system factors (105 occurrences) and screening procedure factors (99 occurrences). The most studied screening procedures concerned cervical cancer/human papillomavirus (n = 33), breast cancer (n = 28), colorectal cancer (n = 25) and the human immunodeficiency virus (n = 12). Other conditions have been under-studied (e.g. cardiovascular problems, lung cancer, syphilis). The individual domain, including determinants such as knowledge, beliefs and emotions, was the most covered across health conditions. Healthcare professional's recommendations and the quality of patient-provider communication were identified to have a strong influence on screening participation in most conditions. The other three domains included determinants which were more specific to a condition or a population. Various determinants modifiable in primary care were found in the individual domain and in the health system, healthcare professional and screening procedure domains. Quality was assessed as low for most systematic reviews included. The identification of various modifiable determinants common across conditions highlights the potential of an integrated screening participation approach. Interventions may address common determinants in a broader person-centred framework within which tailoring to specific procedures or populations can be considered. This approach needs to be explored in intervention studies. The systematic review registration is PROSPERO CRD42019126709.

TEOS: A framework for constructing operational definitions of medication adherence based on Timelines-Events-Objectives-Sources.

AIMS: Managing adherence to medications is a priority for health systems worldwide. Adherence research is accumulating, yet the quality of the evidence is reduced by various methodological limitations. In particular, the heterogeneity and low accuracy of adherence measures have been highlighted in many literature reviews. Recent consensus-based guidelines advise on best practices in defining adherence (ABC) and reporting of empirical studies (EMERGE). While these guidelines highlight the importance of operational definitions in adherence measurement, such definitions are rarely included in study reports. To support researchers in their measurement decisions, we developed a structured approach to formulate operational definitions of adherence. METHODS: A group of adherence and research methodology experts used theoretical, methodological and practical considerations to examine the process of applying adherence definitions to various research settings, questions and data sources. Consensus was reached through iterative review of discussion summaries and framework versions. RESULTS: We introduce TEOS, a four-component framework to guide the operationalization of adherence concepts: (1) describe treatment as four simultaneous interdependent timelines (recommended and actual use, conditional on prescribing and dispensing); (2) locate four key events along these timelines to delimit the three ABC phases (first and last recommended use, first and last actual use); (3) revisit study objectives and design to fine-tune research questions and assess measurement validity and reliability needs, and (4) select data sources (e.g., electronic monitoring, self-report, electronic healthcare databases) that best address measurement needs. CONCLUSION: Using the TEOS framework when designing research and reporting explicitly on these components can improve measurement quality.

Effects of short- and long-acting beta-agonists on asthma exacerbations: a prospective cohort.

BACKGROUND: In asthma, short- and long-acting ß-agonists (SABAs and LABAs) should be used together with inhaled corticosteroids (ICS), and regular use is inappropriate. OBJECTIVE: To assess the relationship between patterns of use of therapy and asthma exacerbations (AEx). METHODS: Patients with asthma (6-40 years) were enrolled in France and the United Kingdom. Prescribing data, computer-assisted telephone interviews (CATIs), and text messages assessed medication use and AEx over a maximum period of 24 months. Generalized linear mixed models provided AEx risks associated with therapy. RESULTS: Among the 908 patients (median age: 20.0 years, 46.6% women, 24.5% children) answering a total of 4248 CATIs over 486 (±235) days, regular (ie, daily) use was more frequent for single LABAs and fixed dose combinations (FDCs) than for single ICS (75.6%, 70.1%, and 65.4% of investigated periods of use, respectively). Regular (ie, daily or almost daily) SABA use was observed for 21.1% of periods of use. Altogether, 265 patients (29.2%) experienced 1 or more AEx. The ORs for AEx risk related to regular vs no use of FDCs, single ICS, and single LABAs were 0.98 (95% CI = [0.73-1.33]), 0.90 (95% CI = [0.61-1.33]), and 1.29 (95% CI = [0.76-2.17]), respectively, after adjustment for cotherapy, sociodemographic, and disease characteristics. The OR was 2.09 (95% CI = [1.36-3.21]) in regular SABA users. CONCLUSION: Inhaled corticosteroids and FDCs were often used intermittently, whereas SABAs and LABAs could be used regularly, and exacerbations were frequent. Compared with non-users, the risk of exacerbation increased moderately under regular use of single LABAs, whereas it doubled, significantly, in regular SABA users, likely in relationship with poor overall asthma control.

Does adherence to inhaled corticosteroids predict asthma-related outcomes over time? A cohort study.

Inhaled corticosteroids (ICS) adherence is important for asthma management. Current evidence on the impact of ICS adherence on outcomes is mostly based on correlational analyses of between-person data. Although it is widely acknowledged that asthma outcomes fluctuate over time, evidence on predictors of within-person change is scarce. We aimed to quantify these fluctuations and the longitudinal relationships between ICS adherence and outcomes at both between- and within-person levels.A prospective cohort of persistent asthma patients in France and the UK (n=847, age 6-40 years) provided 3756 reports over up to 2 years via computer-assisted telephone interviews and text messages on ICS adherence, asthma control, reliever medication use and exacerbations. We examined adherence-outcome relationships via longitudinal models, controlling for confounders, including severity.Considerable within-person variability was found for exacerbations (91%), asthma control (59%) and reliever use (52%); 431 (11.5%) reports signalled exacerbations and 2046 (54.5%) poor control. At between-person level, patients with higher average adherence were more likely to report asthma control (OR 1.25, 95% CI 1.06-1.47), but not asthma exacerbations (OR 0.99, 95% CI 0.87-1.12) or lower reliever use (b -0.0004, 95% CI -0.089-0.088). At within-person level, higher-than-usual adherence was associated with higher concomitant reliever use (b 0.092, 95% CI 0.053-0.131) and lower subsequent reliever use (b -0.047, 95% CI -0.005- -0.088); it was unrelated to asthma control (OR 0.93, 95% CI 0.84-1.02) or exacerbations (OR 1.04, 95% CI 0.94-1.16).Patients maintaining high ICS adherence over time have better asthma control. Temporarily increasing ICS adherence tends to be simultaneous to higher reliever use and reduces reliever use later on. Causes of within-person variation in outcomes require more investigation.

EuroQol (EQ-5D-5L) Validity in Assessing the Quality of Life in Adults With Asthma: Cross-Sectional Study.

BACKGROUND: The EuroQol-5 Dimension (EQ-5D), developed in 1990, is a most widely used generic tool to measure the health-related quality of life (HRQoL) and considered suitable for patients with asthma. In 2009, the EuroQol Group developed a new EQ-5D version to overcome limitations related to its consistently reported high ceiling effect. To enhance the sensitivity for assessing the HRQoL in further patient populations, the number of responses of EQ-5D was increased from 3 to 5 levels (EQ-5D-5L). Moreover, the availability of well-defined requirements for its Web-based administration allows EQ-5D-5L use to monitor the HRQoL in electronic health (eHealth) programs. No study has evaluated the metric properties of the new EQ-5D-5L in patients with asthma yet. OBJECTIVE: This study aims to examine the distribution, construct validity, and reliability of the new EQ-5D-5L questionnaire administered online to adults with asthma. METHODS: We evaluated patients with asthma (age: 18-40 years) from a primary care setting in France and England, who self-completed the EQ-5D-5L questionnaire online. The inclusion criteria were persistent asthma defined as >6 months of prescribed inhaled corticosteroids and long-acting beta-agonists or inhaled corticosteroids alone during the 12 months prior to inclusion. The EQ-5D index was obtained by applying the English preference value set for the new EQ-5D-5L and the French 3L-5L crosswalk value set. Both value sets produced single preference-based indices ranging from 1 (best health state) to negative values (health states valued as worse than death), where 0=death, allowing the calculation of quality-adjusted life years. Responses to dimensions and index distribution, including ceiling and floor effects, were examined. The construct validity was assessed by comparing the means of known groups by analyses of variance and calculation of effect sizes. RESULTS: Of 312 patients answering the baseline Web-based survey, 290 completed the EQ-5D-5L (93%). The floor effect was null, and the ceiling effect was 26.5% (74/279). The mean EQ-5D-5L index was 0.88 (SD 0.14) with the English value set and 0.83 (SD 0.19) with the French 3L-5L crosswalk value set. In both indices, large effect sizes were observed for known groups defined by the Asthma Control Questionnaire (1.06 and 1.04, P<.001). Differences between extreme groups defined by chronic conditions (P=.002 and P=.003 for the English value set and French 3L-5L crosswalk value set, respectively), short-acting beta-agonists (SABAs) canisters in the last 12 months (P=.02 and P=.03), or SABA use during the previous 4 weeks (P=.03 and P=.01) were of moderate magnitude with effect sizes around 0.5. CONCLUSIONS: The new EQ-5D-5L questionnaire has an acceptable ceiling effect, a good construct validity based on the discriminant ability for distinguishing among health-related known groups, and high reliability, supporting its adequacy for assessing the HRQoL in patients with asthma. EQ-5D-5L completion by most Web-based respondents supports the feasibility of this administration form.

Digital technologies and adherence in respiratory diseases: the road ahead.

Outcomes for patients with chronic respiratory diseases remain poor despite the development of novel therapies. In part, this reflects the fact that adherence to therapy is low and clinicians lack accurate methods to assess this issue. Digital technologies hold promise to overcome these barriers to care. For example, algorithmic analysis of large amounts of information collected on health status and treatment use, along with other disease relevant information such as environmental data, can be used to help guide personalised interventions that may have a positive health impact, such as establishing habitual and correct inhaler use. Novel approaches to data analysis also offer the possibility of statistical algorithms that are better able to predict exacerbations, thereby creating opportunities for preventive interventions that may adapt therapy as disease activity changes. To realise these possibilities, digital approaches to disease management should be supported by strong evidence, have a solid infrastructure, be designed collaboratively as clinically effective and cost-effective systems, and reflect the needs of patients and healthcare providers. Regulatory standards for digital interventions and strategies to handle the large amounts of data generated are also needed. This review highlights the opportunities provided by digital technologies for managing patients with respiratory diseases.

Asthma exacerbations and socio-economic status in French adults with persistent asthma: A prospective cohort study.

INTRODUCTION: Adults disadvantaged by poor socio-economic status (SES) are more severely affected by asthma compared to those with better SES. We aimed to determine whether the frequency of asthma exacerbations (AEx), as well as aspects related to AEx management, differed based on SES in patients treated with daily treatments. METHODS: This study, part of the prospective observational cohort ASTRO-LAB, included French adult patients with persistent asthma. Patients were considered as low SES if they benefited from publicly funded special health insurance and/or were perceived as low SES by their general practitioner. AEx was defined as at least one of the following: asthma-related oral corticosteroid course, medical contact, hospitalization, and death. We examined associations between SES and AEx frequency, perceived triggering factors and type of medical contact after AEx. RESULTS: In our sample of 255 patients, 11.40% were considered as low SES. Patients with low SES did not report significantly more AEx than medium/high SES patients during one-year follow-up (0.79 versus 0.55, p = 0.38). The type of medical contact during AEx differed significantly between the two groups (p = 0.03): patients with medium/high SES consulted their general practitioner more frequently (OR = 2.23, 95% CI = 0.91-5.50, p = 0.08) and were less likely to visit an emergency department or be hospitalized (OR = 0.27, 95% CI = 0.09-0.84, p = 0.02). CONCLUSIONS: AEx frequency did not differ significantly between low and medium/high SES patients, but differences were found in the management of AEx. Studies are needed to better understand the relation between precariousness and management of asthma.

Asthma inhaler adherence determinants in adults: systematic review of observational data.

Nonadherence to inhaled medication leads to poor asthma control and increased healthcare utilisation. Many studies exploring adherence determinants have been conducted, but summaries of the evidence are scarce. We performed a systematic review of observational research on determinants of asthma inhaler adherence among adults. We searched for articles in English reporting quantitative observational studies on inhaler adherence correlates among adults in developed countries, published in EMBASE, Medline, PsychInfo and PsychArticles in 1990-2014. Two coders independently assessed eligibility and extracted data, and assessed study quality. Results were summarised qualitatively into social and economic, and healthcare-, therapy-, condition- and patient-related factors. The 51 studies included mainly examined patient-related factors and found consistent links between adherence and stronger inhaler-necessity beliefs, and possibly older age. There was limited evidence on the relevance of other determinants, partly due to study heterogeneity regarding the types of determinants examined. Methodological quality varied considerably and studies performed generally poorly on their definitions of variables and measures, risk of bias, sample size and data analysis. A broader adoption of common methodological standards and health behaviour theories is needed before cumulative science on the determinants of adherence to asthma inhalers among adults can develop further.

Looking Beyond Health-Related Quality of Life: Predictors of Subjective Well-Being among People Living with HIV in the Netherlands.

Health care interventions are increasingly expected to improve subjective well-being (SWB) rather than health-related quality of life (HRQOL) only. However, little is known about how HRQOL and other relevant quality of life (QOL) domains relate to SWB among people living with HIV. People living with HIV treated in Dutch HIV centers (n = 191) completed a cross-sectional survey on SWB, HRQOL, and other QOL domains (social, financial, sexual, and environmental well-being). In bivariate analyses, all QOL domains were significantly related to SWB (r = .17 to .42). In structural equation models, physical health (ß = .14; p < .05), mental health (ß = .27; p < .01), and environmental well-being (ß = .41; p < .01) directly predicted SWB, while financial and social well-being explained SWB indirectly. Thus, environmental well-being and mental health are the main predictors of SWB, and physical health, social well-being, and financial well-being to a lesser extent. Given that most of HIV-care is directed at improving physical health, from the perspective of promoting SWB HIV care should also be directed at other life domains.

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.

An exploratory graphical analysis of the Montgomery-Åsberg Depression Rating Scale pre- and post-treatment using pooled antidepressant trial secondary data.

BACKGROUND: The 10-item Montgomery-Åsberg Depression Rating Scale (MADRS) is a commonly used measure of depression in antidepressant clinical trials. Numerous studies have adopted classical test theory perspectives to assess the psychometric properties of this scale, finding generally positive results. However, its network configural structure and stability is unexplored across different time-points and treatment groups. AIMS: To assess the network structure and stability of the MADRS in clinical settings pre- and post-treatment, and to determine a configurally invariant and stable model across time-points and treatment groups (placebo and intervention). METHOD: Individual participant data for 6440 participants from 14 clinical trials of major depressive disorder was obtained from the data repository Vivli.org. Exploratory Graphical Analysis (EGA) was used to identify empirical models pre-treatment (baseline) and post-treatment (8-week outcome). Bootstrapping techniques were applied to obtain optimised configurally invariant models. RESULTS: Empirical models presented with performance issues at baseline and for the placebo group at outcome. An abbreviated 8-item single-community model was found to be stable and configurally invariant across time-points and treatment groups. Symptoms such as low mood and lassitude showed most centrality across all models. LIMITATIONS: Metric invariance could not be explored due to research environment limitations. CONCLUSIONS: An 8-item one-community variant of the MADRS may provide optimal performance when conducting network analyses of antidepressant clinical trial outcomes. Findings suggest that interventions targeting low mood and lassitude might be most efficacious in treating depression among clinical trial participants. Further considerations of the potential impact on trial design and analysis should be explored.

Evaluating the psychometric structure of the Hamilton Rating Scale for Depression pre- and post-treatment in antidepressant randomised trials: Secondary analysis of 6843 individual participants from 20 trials.

BACKGROUND: The 17-item Hamilton Rating Scale for Depression (HRSD-17) is the most popular depression measure in antidepressant clinical trials. Prior evidence indicates poor replicability and inconsistent factorial structure. This has not been studied in pooled randomised trial data, nor has a psychometrically optimal model been developed. AIMS: To examine the psychometric properties of the HRSD-17 for pre-treatment and post-treatment clinical trial data in a large pooled database of antidepressant randomised controlled trial participants, and to determine an optimal abbreviated version. METHOD: Data for 6843 participants were obtained from the data repository Vivli.org and randomly split into groups for exploratory (n = 3421) and confirmatory (n = 3422) factor analysis. Invariance methods were used to assess potential sex differences. RESULTS: The HRSD-17 was psychometrically sub-optimal and non-invariant for all models. High item variances and low variance explained suggested redundancy in each model. EFA failed at baseline and produced four item models for outcome groups (five for placebo-outcome), which were metric but not scalar invariant. CONCLUSIONS: In antidepressant trial data, the HRSD-17 was psychometrically inadequate and scores were not sex invariant. Neither full nor abbreviated HRSD models are suitable for use in clinical trial settings and the HRSD's status as the gold standard should be reconsidered.

Engagement of medication users in the development and implementation of digital medication adherence technologies: a multi-stakeholder study.

BACKGROUND: This study aims to create a comprehensive framework for the development and implementation of digital medication adherence technologies (DMATech), focusing on critical stages where engagement of medication users (MU) is considered meaningful, i.e. adds significant value, as agreed upon by participating stakeholders. METHODS: Through a literature review and expert consensus, a framework was outlined covering key DMATech development and implementation phases and steps. An in-person workshop with MU representatives and adherence experts, using the Nominal Group Technique, further refined these stages for MU engagement. RESULTS: The DMATech framework included three phases: 'Innovation,' 'Research and Development,' and 'Launch and Implementation,' each encompassing multiple steps. The workshop, attended by five MU representatives and nine adherence experts, identified critical stages for MU input including context analysis, ideation, proof of concept, prototype creation, DMATech's iteration, critical evaluation, healthcare implementation, real-world assessment, and improvement. Nevertheless, there was a divergence of consensus regarding the importance of MUs engagement in regulatory, financial, and marketing aspects. CONCLUSIONS: This study provides a holistic framework for DMATech development and implementation and underscores the necessity of MU engagement at various stages. Modes of MU engagement cannot be generalized; a case-by-case evaluation of engagement strategies is essential.

Impact of treatment adherence and inhalation technique on asthma outcomes of pediatric patients: a longitudinal study.

Introduction: We aimed to evaluate the longitudinal relationships, both at between- and within-person levels, that adherence to inhaled corticosteroid-based maintenance treatment and inhalation technique present with symptom control, exacerbations, and health-related quality of life (HRQoL) in children and adolescents with asthma. Methods: Participants (6-14 years old) from the ARCA (Asthma Research in Children and Adolescents) cohort-a prospective, multicenter, observational study (NCT04480242)-were followed for a period from 6 months to 5 years via computer-assisted telephone interviews and a smartphone application. The Medication Intake Survey-Asthma (MIS-A) was administered to assess the implementation stage of adherence, and the Inhalation Technique Questionnaire (InTeQ) was used to assess the five key steps when using an inhaler. Symptom control was measured with the Asthma Control Questionnaire (ACQ), and HRQL was measured with the EQ-5D and the Patient-Reported Outcomes Measurement Information System-Pediatric Asthma Impact Scale (PROMIS-PAIS). Multilevel longitudinal mixed models were constructed separately with symptom control, exacerbation occurrence, EQ-5D, and PROMIS-PAIS as the dependent variables. Results: Of the 360 participants enrolled, 303 (1,203 interviews) were included in the symptom control and exacerbation analyses, 265 (732) in the EQ-5D, and 215 (617) in the PROMIS-PAIS. Around 60% of participants were male subjects, and most of them underwent maintenance treatment with inhaled corticosteroids plus long-acting ß-agonists in a fixed dose (73.3%). Within-person variability was 83.6% for asthma control, 98.6% for exacerbations, 36.4% for EQ-5D, and 49.1% for PROMIS-PAIS. At the within-person level, patients with higher adherence had better symptom control (p = 0.002) and HRQoL over time (p = 0.016). Patients with a better inhalation technique reported worse HRQoL simultaneously (p = 0.012), but they showed better HRQoL in future assessments (p = 0.012). The frequency of reliever use was associated with symptom control (p < 0.001), exacerbation occurrence (p < 0.001), and HRQoL (p = 0.042); and boys were more likely to present better symptom control and HRQoL than girls. Conclusion: Our results confirm longitudinal associations at the within-person level of the two indicators of quality use of inhalers: for adherence to maintenance treatment with symptom control and HRQoL, and for the inhalation technique with HRQoL. Although treatment adherence was shown to be excellent, a third of the participants reported a suboptimal inhalation technique, highlighting the need for actions for improving asthma management of the pediatric population.