Patient-reported outcome measures to detect intentional, mixed, or unintentional non-adherence to medication: a systematic review.

OBJECTIVE: To categorise patient-reported outcome measures (PROMs) into their propensity to detect intentional and/or unintentional non-adherence to medication, and synthesise their psychometric properties. DESIGN: Systematic review and regression analysis. ELIGIBILITY: Medication adherence levels studied at primary, secondary and tertiary care settings. Self-reported measures with scoring methods were included. Studies without proxy measures were excluded. DATA SOURCES: Using detailed searches with key concepts including questionnaires, reliability and validity, and restricted to English, MEDLINE, EMBASE, CINAHL, International Pharmaceutical Abstracts, and Cochrane Library were searched until 01 March 2022. Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 (PRISMA-2020) checklist was used. DATA ANALYSIS: Risk of bias was assessed via COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN-2018) guidelines. Narrative synthesis aided by graphical figures and statistical analyses. OUTCOME MEASURES: Process domains [behaviour (e.g., self-efficacy), barrier (e.g., impaired dexterity) or belief (e.g., perception)], and overall outcome domains of either intentional (I), unintentional (UI), or mixed non-adherence. RESULTS: Paper summarises evidence from 59 studies of PROMs, validated among patients aged 18-88 years in America, the United Kingdom, Europe, Middle East, and Australasia. PROMs detected outcome domains: intentional non-adherence, n=44 (I=491 criterion items), mixed intentionality, n=13 (I=79/UI=50), and unintentional, n=2 (UI=5). Process domains detected include belief (383 criterion items), barrier (192) and behaviour (165). Criterion validity assessment used proxy measures (biomarkers, e-monitors), and scoring was ordinal, dichotomised, or used Visual Analogue Scale. Heterogeneity was revealed across psychometric properties (consistency, construct, reliability, discrimination ability). Intentionality correlated positively with negative beliefs (r(57)=0.88) and barriers (r(57)=0.59). For every belief or barrier criterion-item, PROMs' aptitude to detect intentional non-adherence increased by ß=0.79 and ß=0.34 units, respectively (R2=0.94). Primary care versus specialised care predicted intentional non-adherence (OR 1.9; CI 1.01 to 2.66). CONCLUSIONS: Ten PROMs had adequate psychometric properties. Of the ten, eight PROMs were able to detect total, and two PROMs were able to detect partial intentionality to medication default. Fortification of patients' knowledge and illness perception, as opposed to daily reminders alone, is most imperative at primary care levels.

Management of COVID-19 vaccines cold chain logistics: a scoping review.

BACKGROUND: Successful mass vaccination programmes are public health achievements of the contemporary world. While pharmaceutical companies are actively developing new vaccines, and demonstrating results of effectiveness and safety profiles, concerns on COVID-19 vaccine management are under-reported. We aimed to synthesise the evidence for efficient cold chain management of COVID vaccines. METHODS: The scoping review's conduct and reporting were based on the PRISMA-ScR 2018 checklist. We searched from April 2020 to January 2022 for publications in PubMed (LitCovid), Scopus and ScienceDirect. All review stages were pilot-tested to calibrate 2 reviewers. Articles on cold chain logistics and management were included, while publications solely describing COVID vaccines, their development and clinical aspects of the vaccine, were excluded. To capture relevant data, charting was conducted by one reviewer and verified by another. Results were analysed thematically and summarised descriptively in a table and in-text. RESULTS AND DISCUSSION: We assessed 6984 potentially relevant citations. We included 14 publications originating from USA (n = 6), India (n = 2), Finland, Spain, Bangladesh, Netherlands, Switzerland and Ethiopia. They were reported as reviews (4), policy or guidance documents (3), experimental studies (2), case reports (2), expert commentary (1), phenomenological study (1), and decision-making trial and evaluation laboratory trial (1). The findings were presented in three themes: (i) regulatory requirements for cold-chain logistics, (ii) packaging and storage, and (iii) transportation and distribution. A conceptual framework emerged linking regulatory requirements, optimal logistics operation and formulation stability as the key to efficient cold chain management. Recommendations were made for improving formulation stability, end-product storage conditions, and incorporating monitoring technologies. CONCLUSION: COVID-19 vaccines require special end-to-end supply cold chain requirements, from manufacture, and transportation to warehouses and healthcare facilities. To sustain production, minimise wastage, and for vaccines to reach target populations, an efficient and resilient vaccine supply chain which is assisted by temperature monitoring technologies is imperative.