Inconclusiveness of psychometric testing of medication adherence questionnaires.

PURPOSE: To propose a paradigm change for the validation procedures of medication adherence questionnaires. METHODS: A total of 121 validation procedures of unique questionnaires for medication adherence were analyzed. RESULTS: "Construct validity" and "internal consistency" were most often assessed, and test results varied largely. A more in-depth analysis indicated that the assessment of medication non-adherence included distinct but related constructs, such as the extent to which doses are missed, and the attempt to identify different facets of medication-taking behavior. Consequently, each construct requires a different measurement approach with different psychometric tests for establishing its validity and reliability. CONCLUSION: Results show that assessing the validity and reliability of adherence questionnaires with standard procedures including statistical tests is inconclusive. Refinement of the constructs of non-adherence is needed in pharmacy and medical practice. We suggest a distinction between the (i) extent of missed doses over the past 2 weeks, (ii) modifiable reasons for non-adherence behavior, and (iii) unmodifiable factors of non-adherence. Validation procedures and corresponding statistical methods should be selected according to the specific single constructs.

Rescue Analgesia for Opioid-Dependent Individuals on Opioid Agonist Treatment during Hospitalization: Adherence to Guideline Treatment.

INTRODUCTION: Opioid agonist treatment (OAT) is the first-line treatment for opioid use disorder (OUD). Simultaneously, opioids are essential medicines in acute pain management. The literature is scarce on acute pain management in individuals with OUD, and guidelines are controversial for patients on OAT. We aimed at analyzing rescue analgesia in opioid-dependent individuals on OAT during hospitalization in the University Hospital Basel, Switzerland. METHODS: Patient hospital records were extracted from the database over 6 months (Jan-Jun) in 2015 and 2018. Of the 3,216 extracted patient records, we identified 255 cases on OAT with full datasets. Rescue analgesia was defined according to established principles of acute pain management, e.g., i) the analgesic agent is identical to the OAT medication, and ii) the opioid agent is dosed above 1/6th morphine equivalent dose of the OAT medication. RESULTS: The patients were on average 51.3 ± 10.5 years old (range: 22-79 years), of which 64% were men. The most frequent OAT agents were methadone and morphine (34.9% and 34.5%). Rescue analgesia was not documented in 14 cases. Guideline-concordant rescue analgesia was observed in 186 cases (72.9%) and consisted mostly of NSAIDs, including paracetamol (80 cases), and identical agents such as the OAT opioid (70 cases). Guideline-divergent rescue analgesia was observed in 69 (27.1%) cases, predominantly due to an underdosed opioid agent (32 cases), another agent other than the OAT (18 cases), or contraindicated agents (10 cases). DISCUSSION: Our analysis suggests that rescue analgesia in hospitalized OAT patients was predominantly concordant with guidelines, while divergent prescriptions seemed to follow common principles of pain medicine. Clear guidelines are needed to appropriately treat acute pain in hospitalized OAT patients.

Knowledge and attitudes of German and Swiss community pharmacists towards biologicals and biosimilars - a prospective survey before and after the COVID-19 pandemic.

BACKGROUND: Knowledge, attitudes and substitution laws of biosimilars are not consistent across countries. Biosimilar acceptance among patients and healthcare professionals may be suffering from gaps in knowledge and understanding about biosimilars and their regulatory approval process. Pharmacists' roles and responsibilities changed considerably during the COVID-19 pandemic. Thus, they might have gained new skills and self-confidence in counseling and substitution of biosimilars. AIMS: To examine and compare the knowledge, perceptions and information needs of German and Swiss pharmacists regarding original biologicals and biosimilars in 2020 and 2022. METHODS: We conducted an online survey among Swiss and German community pharmacies in February 2020 (before) and August 2022 (after the COVID-19 pandemic). Descriptive statistics were calculated and the Chi-Square test was used for comparisons among categorical variables. RESULTS: A total of 764 pharmacists took part in the survey (390 in 2020 and 374 in 2022) with comparable demographics. The frequency of dispensing biologicals remained similar between German and Swiss pharmacists in 2020 and 2022, but the Swiss dispensation of biosimilars increased significantly in 2022 compared to 2020. Concerning the understanding of the term biosimilars, knowledge remained moderate in both countries in both years. Participants were equally familiar with the term and most felt sufficiently informed. In both countries, substitution with a biosimilar showed the least confidence of all attitudes. A third of the participants indicated correct substitution rules in their country. In both years, around 85% of the participants were highly interested in additional training on this topic. DISCUSSION/CONCLUSION: The results indicate that similarities and differences between Germany and Switzerland regarding knowledge and attitudes towards biologicals and biosimilars remained unchanged before and after the COVID-19 pandemic. An influence of the pandemic is unlikely. There is still a clear lack of knowledge among community pharmacists on biosimilars, especially regarding the substitution rules. Due to a rising market with many benefits but also big challenges to overcome, the topic of biosimilars should receive more attention in the future. This requires additional training for pharmacists.

Towards better reporting of the proportion of days covered method in cardiovascular medication adherence: A scoping review and new tool TEN-SPIDERS.

Although medication adherence is commonly measured in electronic datasets using the proportion of days covered (PDC), no standardized approach is used to calculate and report this measure. We conducted a scoping review to understand the approaches taken to calculate and report the PDC for cardiovascular medicines to develop improved guidance for researchers using this measure. After prespecifying methods in a registered protocol, we searched Ovid Medline, Embase, Scopus, CINAHL Plus and grey literature (1 July 2012 to 14 December 2020) for articles containing the terms "proportion of days covered" and "cardiovascular medicine", or synonyms and subject headings. Of the 523 articles identified, 316 were reviewed in full and 76 were included (93% observational studies; 47% from the USA; 2 grey literature articles). In 45 articles (59%), the PDC was measured from the first dispensing/claim date. Good adherence was defined as 80% PDC in 61 articles, 56% of which contained a rationale for selecting this threshold. The following parameters, important for deriving the PDC, were often not reported/unclear: switching (53%), early refills (45%), in-hospital supplies (45%), presupply (28%) and survival (7%). Of the 46 articles where dosing information was unavailable, 59% reported how doses were imputed. To improve the transparent and systematic reporting of the PDC, we propose the TEN-SPIDERS tool, covering the following PDC parameters: Threshold, Eligibility criteria, Numerator and denominator, Survival, Presupply, In-hospital supplies, Dosing, Early Refills, and Switching. Use of this tool will standardize reporting of the PDC to facilitate reliable comparisons of medication adherence estimates between studies.

Identification of Patients with Cobalamin Deficiency Crucially Depends on the Diagnostic Strategy.

BACKGROUND: Our goal was to determine vitamin B12 (cobalamin) deficiency with different diagnostic strategies, to propose the best possible laboratory strategy, and to synthesize the relevance of biomarkers in the diagnosis of a cobalamin deficiency. METHODS: We performed a secondary data analysis. The testing strategies were (i) vitamin B12 solely, (ii) holotranscobolamin solely, (iii) vitamin B12 and holotranscobolamin, and (iv) reflex testing of holotranscobalamin in samples with vitamin B12 < 300 pmol. A set of 3,044 laboratory samples with vitamin B12 and holotranscobalamin serum values from unselected in- and outpatients from a secondary care hospital. A sample was classified as cobalamin deficient when low values of vitamin B12 < 137 pmol/L or holotranscobalamin ≤ 37 pmol/L were measured. RESULTS: Low cobalamin values were identified in 591 (19.4%) samples either according to low vitamin B12 values (305; 10.0%) or low holotranscobalamin values (436; 14.3%). For 2,404 values with vitamin B12 < 300 pmol/L, the additional measurement of holotranscobalamin (reflex-testing) enabled the detection of an additional 278 (9.1%) deficiencies. When the grey zone was decreased to 138 - 219 pmol/L, the reflex testing of an additional 1,240 samples identified a total of 511 (16.8%) samples as cobalamin deficient. CONCLUSIONS: The identification of cobalamin deficiency or sufficiency highly depends on the diagnostic strategy. A reflex testing with a grey zone for vitamin B12 < 220 pmol/L identifies cobalamin deficiency cost efficiently in 86.5% cases (511 out of 591). Physicians should apply a uniform strategy on how to address the diagnosis of cobalamin deficiency and indication for treatment. In-hospital guidelines, which describe methodology and sensitivity of the locally used assays for vitamin B12 and holotranscobalamin could guide them.

Insights Into Direct Oral Anticoagulant Therapy Implementation of Stroke Survivors with Atrial Fibrillation in an Ambulatory Setting.

OBJECTIVES: To describe how stroke survivors with atrial fibrillation implement direct oral anticoagulant treatment and propose appropriate metrics to describe adherence. MATERIALS AND METHODS: Stroke patients with atrial fibrillation electronically recorded their self-administered direct oral anticoagulants (apixaban, dabigatran, edoxaban, rivaroxaban) during a 6-month observation phase after hospitalisation for ischemic stroke. Taking and timing adherence, correct dosing days, drug holidays, time of the day and day of the week subsets, dose-to-dose intervals and longest intervals between two consecutive doses were calculated from electronic monitoring data to describe and discuss the implementation phase of adherence. RESULTS: Data from 41 patients were analysed. Median age was 77 (IQR = 69-84), 63.4% were male and the majority suffered a mild stroke (median NIHSS: 1). Mean taking and timing adherence exceeded 90%. Correct dosing occurred in 86.6% of the days. Seven patients (17.1%) had intake pauses of three or more consecutive days. Patients with twice-daily regimen (70.7%) had higher taking adherence in the morning than in the evening (94.4% versus 89.9%; p = 0.001). No therapy- or anamneses-related characteristic was associated with taking adherence. CONCLUSIONS: Although adherence to direct oral anticoagulants of stroke patients with atrial fibrillation exceeded 90%, deviant intake patterns such as drug holidays and missed evening doses were common and raise concerns. Appropriate adherence metrics calculated from electronic monitoring data may guide healthcare professionals elucidating patient-tailored adherence-enhancing interventions. ClinicalTrials.gov registration number: NCT03344146.

The ABC taxonomy for medication adherence translated into French and German.

AIMS: We translated the ABC adherence taxonomy (i.e. 7 terms and their corresponding definitions) published by Vrijens et al. (2012) into French and German without changing the original meaning with the aim to promote a standardised taxonomy for medication adherence to French- and German-speaking researchers and clinicians. METHODS: A Delphi survey was performed. To generate round 1, we identified French and German synonyms for the 7 adherence terms through a literature search in PubMed. Investigators translated the original English definitions into French and German. Panellists were members of ESPACOMP-the International Society for Patient Medication Adherence; experts suggested by ESPACOMP members and first authors of medication adherence publications in French and German. Google forms were used to create online questionnaires. Delphi rounds were performed until consensus was reached. The consensus was defined according to the acceptance rate as moderate consensus (50-75%), consensus (>75-95%), and strong consensus (>95%). RESULTS: The literature search resulted in 4-6 (French) and 4-7 (German) items per English term. Delphi rounds were launched between November 2016 and April 2018. Three rounds sufficed to reach consensus on all terms and definitions from 26 French-speaking and 25 German-speaking panellists. Preferred terms for medication adherence are adhésion médicamenteuse (82%) in French and Medikamentenadhärenz (88%) in German. CONCLUSION: The use of a common terminology for medication adherence with translations in French and German will contribute to standardise the vocabulary, to harmonise research projects and ultimately ease comparison of study results among researchers and clinicians.

Does a tailored intervention to promote adherence in patients with chronic lung disease affect exacerbations? A randomized controlled trial.

BACKGROUND: Poor medication-adherence is common in chronic lung patients, resulting in reduced health-outcomes and increased healthcare-costs. This study aimed to investigate the impact of an acoustic reminder and support calls on adherence to inhaled therapy in asthma and COPD patients and to determine their effect on exacerbations. METHODS: This single-blinded randomized controlled trial investigated asthma and COPD patients during 6 months in an ambulatory setting. The intervention consisted of daily alarm clock and support phone calls, whenever use of rescue medication doubled or inhaled medication was not taken as prescribed. Primary outcome was time to next exacerbation. Frequency of exacerbations, adherence to inhaled medication and quality of life scores were secondary outcomes. Cox and Poisson regression were used to determine intervention effect on time to exacerbation and frequency of exacerbations, respectively. RESULTS: Seventy-five participants were assigned to the intervention group and 74 to usual follow-up care. During a median follow-up of 6.2 months, 22 and 28% in the intervention and control groups respectively, experienced at least one exacerbation. Intervention had no effect on time to first exacerbation (HR 0.65, 95% CI 0.21 to 2.07, P = .24), but showed a trend toward a 39% decreased frequency of exacerbations (RR = 0.61, 95% CI 0.35 to 1.03, P = .070) for the adjusted models, respectively. The intervention group had significantly more days with 80-100% taking adherence regarding puff inhalers (82 ± 14% vs. 60 ± 30%, P < .001) and dry powder capsules (90 ± .10% vs. 80 ± 21%, P = .01). Timing adherence in participants using puff inhalers was higher in the intervention group (69 ± 25% vs. 51 ± 33%, P < .001). No significant differences in QoL were found between the two groups. CONCLUSION: Participants assigned to the intervention group had significantly better taking and timing adherence of inhaled medication resulting in a trend towards a decreased frequency of exacerbations. However, no effect on time to next exacerbation was observed. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02386722, Registered 14 February 2014.

Do Swiss community pharmacists address the risk of sexually transmitted infections during a consultation on emergency contraception? A simulated patient study.

Objectives: Since 2002, Swiss community pharmacists have dispensed emergency contraception (EC) as pharmacist-only medicine ideally using the official Swiss protocol. Our study aimed to determine pharmacists' resolution of an imaginary EC case, compliance with the protocol, and provision of information on the risk of sexually transmitted infections (STIs). Methods: We conducted a simulated patient study with 69 students who each visited a community pharmacy. The scenario started with the student requesting the 'morning after pill'. Current practice was assessed using an online evaluation form adapted from the Medication-Related Consultation Framework. Descriptive and statistical analyses were carried out. Results: All pharmacists correctly identified that the person needed EC. All pharmacists used an EC protocol and asked on average 10.9 (standard deviation 0.68) of 11 compulsory EC assessment questions. In total, 93% of pharmacists addressed EC counselling items and 56% addressed the risk of STIs, mainly by mentioning that condoms offered the best protection (76%). Conclusions: Community pharmacists correctly issued the EC, complied with the dispensing protocol and used their professional judgement to ensure optimal EC use. There is nevertheless room for improvement regarding pharmacists' STI counselling. Finally, the protocol's STI section could be enriched with specific information to guide counselling.

Use and inhalation technique of inhaled medication in patients with asthma and COPD: data from a randomized controlled trial.

BACKGROUND: The burden of asthma and COPD among patients is high and people affected are frequently hospitalized due to exacerbations. There are numerous reasons for the lack of disease control in asthma and COPD patients. It is associated with non-adherence to guidelines on the part of the health care provider and with poor inhalation technique and/or non-adherence to the prescribed treatment plan by the patient. This study aims to present data on inhaler technique and its impact on quality of life (QoL) and symptom control in a typical population of patients with chronic lung disease from a randomized controlled trial on medication adherence. METHODS: For this cross-sectional analysis, 165 asthma and COPD patients were analyzed. Correct application of inhaler devices was tested using pre-defined checklists for each inhaler type. QoL and symptom control were investigated using COPD Assessment Test (CAT) and Asthma Control Test (ACT). Spirometry was used to measure forced vital capacity (FVC) and forced expiratory volume in one second (FEV1). RESULTS: Overall, incorrect inhalation technique ranged from 0 to 53% depending on the type of inhaler. COPD patients with incorrect device application had a higher CAT sum score compared to those with a correct device application (P = .02). Moreover, COPD patients with incorrect device application were more likely to suffer from cough (P = .03) and were more breathless while walking uphill or a flight of stairs (P = .02). While there was no significance found in asthma patients, COPD patients who used their devices correctly had a significantly better mean FEV1% predicted at baseline compared to those who applied their devices incorrectly (P = .04). CONCLUSIONS: Correct inhalation of prescribed medication is associated with improved health status and lung function. These findings should encourage health professionals to provide instructions on correct inhalation technique and to regularly re-evaluate the patients' inhalation technique. TRIAL REGISTRATION: ClinicalTrials.gov: NCT0238672 , Registered 14 February 2014.

Novel remote electronic medication supply model for opioid-dependent outpatients with polypharmacy--first long-term case study.

BACKGROUND: Patients with substance use disorders grow older thanks to effective treatments. Together with a high prevalence of comorbidities, psychological problems, and low social support, these patients are at high risk for medication non-adherence. Established treatment facilities face challenges to accommodate these complex patients within their setting. Electronic medication management aids (e-MMAs) might be appropriate to simultaneously monitor and improve adherence for these patients. CASE PRESENTATION: We report the first long-term experiences with a novel remote electronic medication supply model for two opioid-dependent patients with HIV. John (beginning dementia, 52 years, 6 tablets daily at 12 am) and Mary (frequent drug holidays, 48 years, 5-6 tablets daily at 8 pm) suffered from disease progression due to non-adherence. We electronically monitored adherence and clinical outcomes during 659 (John) and 953 (Mary) days between July 2013 and April 2016. Both patients retrieved over 90% of the pouches within 75 min of the scheduled time. Technical problems occurred in 4% (John) and 7.2% (Mary) of retrievals, but on-site support was seldom required. Viral loads fell below detection limits during the entire observation period. CONCLUSIONS: Continuous medication supply and persistence with treatment of over 1.7 years, timing adherence of more than 90%, and suppressed HIV viral load are first results supporting the feasibility of the novel supply model for patients on opioid-assisted treatment and polypharmacy.

Stability of medicines after repackaging into multicompartment compliance aids: eight criteria for detection of visual alteration.

INTRODUCTION: Multicompartment compliance aids (MCA) are widely used by patients. They support the management of medication and reduce unintentional nonadherence. MCA are filled with medicines unpacked from their original packaging. Swiss pharmacists currently provide MCA for 1-2 weeks, although little and controversial information exists on the stability of repackaged medicines. OBJECTIVE: We aimed to validate the usefulness of a simple screening method capable of detecting visual stability problems with repackaged medicines. METHODS: We selected eight criteria for solid formulations from The International Pharmacopoeia: (1) rough surface, (2) chipping, (3) cracking, (4) capping, (5) mottling, (6) discoloration, (7) swelling, and (8) crushing. A selection of 24 critical medicines was repackaged in three different MCA (Pharmis®, SureMed™, and self-produced blister) and stored at room temperature for 4 weeks. Pharmis® was additionally stored at accelerated conditions. Appearance was scored weekly. RESULTS: Six alterations (rough surface, cracking, mottling, discoloration, swelling, and crushing) were observed at accelerated conditions. No alteration was observed at room temperature, except for the chipping of tablets that had been stuck to cold seal glue. CONCLUSION: The eight criteria can detect alterations of the appearance of oral solid medicines repackaged in MCA. In the absence of specific guidelines, they can serve as a simple screening method in community pharmacies for identifying medicines unsuitable for repackaging.

Proposal of Standardization to Assess Adherence With Medication Records: Methodology Matters.

BACKGROUND: Medication adherence is the process by which patients take their medication as prescribed and is an umbrella term that encompasses all aspects of medication use patterns. Ambiguous terminology has emerged to describe a deviation from prescribed regimen, forcing the European ABC Project to define 3 phases of medication use: initiation, implementation, and discontinuation. However, different measures of medication adherence using medication records are currently available that do not always distinguish between these phases. The literature is lacking standardization and operationalization of the assessment methods. OBJECTIVE: To propose a harmonization of standards as well as definitions of distinct measures and their operationalization to quantify adherence to medication from medication records. METHODS: Group discussions and consensus process among all coauthors. The propositions were generated using the authors' experiences and views in the field of adherence, informed by theory. RESULTS: The concepts of adherence measures within the new taxonomy were harmonized, and the standards necessary for the operationalization of adherence measures from medication records are proposed. Besides percentages and time-to values, the addition of a dichotomous value for the reinitiation of treatment is proposed. Methodological issues are listed that should be disclosed in studies on adherence. CONCLUSIONS: The possible impact of the measures in adherence research is discussed. By doing this, the results of future adherence research should gain in accuracy. Finally, studies will become more transparent, enabling comparison between studies.

[Adverse drug effects in the community pharmacy]. / Unerwünschte Arzneimittelwirkungen in der Offizinapotheke.

Community pharmacists represent an important pillar for the identification and the reporting of adverse drug effects (ADE}. Thanks to their broad view on the pharmacotherapy, over-the-counter medication included, they contribute greatly to the improvement of drug safety. In principle, the community pharmacy will face three groups of ADE which require specific attention. This article deals with these specific ADE groups and presents some illustrative examples from daily practice. Furthermore, we suggest some solutions to identify potential relevant interactions - including herbal-drug interactions - and give tips for daily practice, along with some often overseen cutaneous ADE.

Antiplatelet resistance in outpatients with monitored adherence.

Antiplatelet resistance with aspirin and clopidogrel has been associated with clinical, cellular and pharmacogenetic factors; and non-adherence has been considered as a major contributor to resistance in outpatients. We aimed at assessing factors to resistance when adherence to the antiplatelet drugs and all other oral solid drugs was controlled for. In a pilot study, we tested arachidonic acid and/or ADP-induced in vitro platelet aggregation of 82 outpatients with chronic aspirin and/or clopidogrel treatment before and after a one-week period of measuring the patient's adherence with the polymedication electronic monitoring system (POEMS). Resistance was found in 20% (aspirin; n = 69) and 25% (clopidogrel; n = 32) of the patients after monitored adherence. Mean platelet aggregation was not (aspirin) or non-significantly (clopidogrel) lowered when compared to baseline. Diabetes mellitus and inflammation were consistently associated with resistance to both drugs, but CYP2C19 polymorphisms could not be confirmed as predictors of clopidogrel response. Electronically compiled multidrug dosing histories allowed the concomitant intake of high-dose lipophilic statins to be identified as a risk factor of impaired response to clopidogrel and revealed that exposure to further potential drug-drug interactions (DDIs) was too low for analysis. Multidrug adherence monitoring allowed thus dismissing non-adherence as a major contributor to resistance and inter-individual response variability in an outpatient setting. Additionally, it allowed analysing the impact of DDIs according to the actual exposure to the potentially interfering drugs. Further studies based on this methodology are essential to prevent misleading results due to incomplete adherence and gain additional insight into the impact of timing adherence on antiplatelet drug response.

[Guide to perfect prescribing in Switzerland]. / Wie schreibe ich ein perfektes Rezept in der Schweiz?

An important initial step in the medication process is prescription writing. The more perfect it is, the more successfully can a therapy be performed. Imprecisions and missing information lead to unnecessary queries or to errors which are often randomly discovered during a later consultation. A "perfect prescription" serves every individual involved in the medication process. The prescription document contains the instructions for the patient, the pharmacist, the nurse, and other health professionals involved in the therapy. The prescription writing process is regulated by several laws and decrees which were enacted to assure the greatest possible drug safety. Deviations from the norm may be necessary in individual cases, which require an even more responsible prescribing and explicit indication.

Adherence Monitoring Package (AMoPac) in patients suspected of non-response to antihypertensive treatment: perceived usefulness by general practitioners.

BACKGROUND: Non-adherence to antihypertensive agents is common, mainly because of the low perceived burden of high blood pressure. General practitioners (GPs) are unable to predict whether patients are adhering to a recommended treatment. Knowledge about adherence might be of clinical interest in patients non-responding to antihypertensive treatment. AIM: To assess the usefulness of an Adherence Monitoring Package (AMoPac) to identify non-adherence in patients non-responding to antihypertensive treatment. METHODS: AMoPac consists of (1) 4 weeks of electronic adherence monitoring, (2) pharmacist's feedback on patient's intake behaviour and (3) adherence metrics including clinical-pharmaceutical recommendations to the GP. AMoPac-HYP ('Adherence Monitoring Package to identify non-adherence in ambulatory HYPertensive patients') is an observational study among GPs and ambulatory patients with hypertension in a real-world setting. The primary outcome was GPs' perceived usefulness of AMoPac. Secondary outcomes were (1) frequency of medication problems and prescribing errors; (2) types of pharmacist's' recommendations; (3) acceptance of the recommendations by GPs; (4) medication adherence and (5) patients' satisfaction. Outcomes are reported descriptively. Data were collected with questionnaires and electronic monitoring of medicine intake. RESULTS: Fifteen GPs and 15 patients with hypertension participated in the AMoPac-HYP Study. Patients were on average 62 years old, and mean blood pressure was 137/83 mmHg. All GPs rated AMoPac as useful. The most frequently mentioned use was excluding non-adherence in patients with hypertension (93%). Medication problems and prescribing errors were observed in 80% of the patients. The study pharmacist recommended adherence support (N=9 patients) and treatment optimisation (N=8 patients). The recommendations were accepted and implemented in 10 of 17 cases by the GP. Patients' mean taking and timing adherence were 90% and 86%, respectively. Satisfaction with the study procedures among patients was high. CONCLUSION: AMoPac was rated as useful for identifying and excluding non-adherence in patients with hypertension and was highly accepted among patients. Including adherence data in clinical decision-making could contribute to optimising patient care.

Practices and Barriers in Developing and Disseminating Plain-Language Resources Reporting Medical Research Information: A Scoping Review.

BACKGROUND: The intent of plain-language resources (PLRs) reporting medical research information is to advance health literacy among the general public and enable them to participate in shared decision-making (SDM). Regulatory mandates coupled with academic and industry initiatives have given rise to an increasing volume of PLRs summarizing medical research information. However, there is significant variability in the quality, format, readability, and dissemination channels for PLRs. In this scoping review, we identify current practices, guidance, and barriers in developing and disseminating PLRs reporting medical research information to the general public including patients and caregivers. We also report on the PLR preferences of these intended audiences. METHODS: A literature search of three bibliographic databases (PubMed, EMBASE, Web of Science) and three clinical trial registries (NIH, EMA, ISRCTN registry) was performed. Snowball searches within reference lists of primary articles were added. Articles with PLRs or reporting topics related to PLRs use and development available between January 2017 and June 2023 were identified. Evidence mapping and synthesis were used to make qualitative observations. Identified PLRs were quantitatively assessed, including temporal annual trends, availability by field of medicine, language, and publisher types. RESULTS: A total of 9116 PLRs were identified, 9041 from the databases and 75 from clinical trial registries. The final analysis included 6590 PLRs from databases and 72 from registries. Reported barriers to PLR development included ambiguity in guidance, lack of incentives, and concerns of researchers writing for the general public. Available guidance recommendations called for greater dissemination, increased readability, and varied content formats. Patients preferred visual PLRs formats (e.g., videos, comics), which were easy to access on the internet and used short jargon-free text. In some instances, older audiences and more educated readers preferred text-only PLRs. Preferences among the general public were mostly similar to those of patients. Psychology, followed by oncology, showed the highest number of PLRs, predominantly from academia-sponsored research. Text-only PLRs were most commonly available, while graphical, digital, or online formats were less available. Preferred dissemination channels included paywall-free journal websites, indexing on PubMed, third-party websites, via email to research participants, and social media. CONCLUSIONS: This scoping review maps current practices, recommendations, and patients' and the general public's preferences for PLR development and dissemination. The results suggest that making PLRs available to a wider audience by improving nomenclature, accessibility, and providing translations may contribute to empowerment and SDM. Minimizing variability among available guidance for PLR development may play an important role in amplifying the value and impact of these resources.

Plain-language resources (PLRs) can help people understand medical research information. This will allow them to make informed decisions about their health. However, PLRs vary in quality, format, and ways in which they are shared. In this study, researchers looked at how PLRs are made and publicly shared. They also studied what makes PLRs useful for the public and patients. Creating PLRs is not easy because of unclear guidelines on writing for the public. Using different formats and languages can make PLRs readable. Patients preferred PLRs as videos and comics. Older and educated readers liked text-only PLRs. The fields of psychology and oncology had the highest number of PLRs. Text-only PLRs were more common than digital or online formats. PLRs should be easily and freely accessible. Open-access journal websites, PubMed, third-party websites, email, and social media can be used to share PLRs. This study showed that PLRs can be helpful, but there are challenges in creating and sharing them. Good PLRs can inform patients and help them make better health-related decisions.

Initiation of oral hepatitis C virus treatment: Which barriers are pertinent for ambulatory individuals with a history of illicit substance use? A qualitative interview study.

Background and Aims: The World Health Organization has set a goal to eradicate hepatitis C virus (HCV) by the year 2030. Nonadherence to HCV treatment has substantial economic implications due to high treatment costs, among others. Barriers to start HCV treatment may be critical. The aim of this study was to assess pertinent barriers to HCV treatment in ambulatory patients with a history of illicit substance use and to compare them to the literature. Methods: Barriers to HCV treatment mentioned by the key risk group (i.e., people who inject drugs) were retrieved from literature through a pragmatic literature search. From 34 published articles, we identified 80 modifiable barriers that were bundled in 23 items within the four topics "Personal difficulties and barriers to treatment," "Personal motivation to be treated," "Knowledge about the disease," and "Received information about the medicine." In-depth semistructured interviews were performed face-to-face with ambulatory patients from the University Psychiatric Clinics in Basel, Switzerland. Transcripts were coded inductively. Results: Interviews were performed with seven individuals (mean age: 48.3 years; range: 38-63 years; one woman) treated with oral direct-acting antivirals between 2014 and 2022. Thirteen barriers to start HCV treatment were mentioned that corresponded to the five categories: information, attitudes, swallowing difficulties, social environment, and unfavorable lifestyle. The barrier "swallowing difficulties" emerged exclusively from the statements provided by the interviewees. Conclusion: Barriers to the initiation of HCV treatment indicated by our interviewees clearly differed from the literature. Notably, the challenge of swallowing medicines may be particularly relevant for physicians prescribing and pharmacists dispensing HCV medication.

Concordance between pharmacy dispensing and electronic monitoring data of direct oral anticoagulants - A secondary analysis of the MAAESTRO study.

BACKGROUND: Direct oral anticoagulants are the preferred treatment for stroke patients with atrial fibrillation. Pharmacy dispensing data represent a practical method to identify suboptimal medication adherence. OBJECTIVE: This study investigates whether pharmacy dispensing data are indicative of real-life adherence behavior, using data from 130 patients in the MAAESTRO study (2018-2022) in Basel, Switzerland. METHODS: This secondary data analysis of the MAAESTRO study (Dietrich, 2024) included patients with electronic monitoring (EM) and dispensing data for 12 months. Patients with at least two refills were included in the analysis. We categorized refill series into three adherence patterns using the Delta T method (Baumgartner, 2022): all refills on time, erratic refills, end-gaps ≥10 days. EM-adherence was assessed through "taking adherence" and "missing days" (24h without intake). We analyzed: i) all dispensing data ("all refills"); ii) all data independently of the MAAESTRO phase ("all phases"); iii) the last two dispensing data ("last"), and iv) EM data from the MAAESTRO phase that match the date of the last refill ("matched"). Associations between refill patterns and adherence were examined using Spearman correlation and Fisher's exact test. RESULTS: Data analyzed from 50 patients (mean age 76.4 ± 9.1 years, 56.0 % male) included 252 refills with a median of 4 refills per patient. Refill patterns were: all refills on time (40.0 %), erratic refills (36.0 %), and end-gaps >10 days (24.0 %). Mean taking adherence was 89.3 ± 13.7 %. EM data revealed missing days in 82.0 % of patients, with 61.0 % having irregular refill patterns. Matched taking adherence was moderately associated with Delta T over all refills (p = 0.034) and the last refill (p = 0.013). CONCLUSIONS: Dispensing data processed with the Delta T method correlate moderately with EM data. The Delta T value for the last two refills shows promise for estimating irregular adherence, suggesting potential for targeted interventions in pharmacy practice.