A Mixed-Methods Study of the Technical Feasibility and Patient Acceptability of a Real-Time Adherence Monitor in Breast Cancer Survivors Taking Adjuvant Endocrine Therapy

Purpose: Oral anti-cancer medications are increasingly common and endocrine therapies represent the most common oral anti-cancer medications in breast cancer. Adjuvant endocrine therapies reduce the likelihood of recurrence and mortality in the approximately 80% of women diagnosed with hormone-receptor positive breast cancer, thus rendering adherence essential. Real-time medication adherence monitors, such as the Wisepill electronic pillbox, transmit adherence data remotely, allowing for early intervention for non-adherence. However, their feasibility and acceptability have yet to be examined among breast cancer survivors taking endocrine therapies.Methods: This study presents quantitative patient-report and technical support data and qualitative patient acceptability data on using Wisepill, a common real-time adherence monitor, among 88 breast cancer survivors prescribed adjuvant endocrine therapy.Results: This mixed-methods study of a common real-time adherence monitor, among the first in breast cancer survivors taking adjuvant endocrine therapy, demonstrates its technical feasibility and patient acceptability.Conclusion: The use of wireless medication monitors that transmit real-time adherence data are uniquely promising for maximizing the benefits of adjuvant endocrine therapy by allowing for continuous tracking, ongoing communication with oncologic or research teams, and early intervention. This study demonstrates the feasibility and patient acceptability of one such real-time adherence monitor.

Technologies for Monitoring Medication Adherence: Important Aspects to Consider for Technology Assessment (Preprint)

BACKGROUND Accurately measuring and monitoring patient medication adherence is a global challenge due to the absence of “gold standard” methods for adherence measurement. Recent attentions have turned towards the adoption of technologies for medication adherence monitoring as they provide the opportunity for continuous tracking of individual medication adherence behavior. Yet, current medication adherence monitoring technologies vary by their technical features and methods of adherence data capture, leading to differences in their respective advantages and limitations. Overall, there is a lack of appropriate criteria to guide the assessment of medication adherence monitoring technologies for optimal adoption and utilization. OBJECTIVE This study aimed to provide a concise overview and summary of current medication adherence monitoring technologies and propose a set of technology assessment criteria to aid in the development and adoption of these technologies. METHODS A literature search was conducted on PubMed, Scopus, CINAHL, and ProQuest Technology Collection (January 2010-June 2021) using the combination of keywords "medication adherence," "measurement technology," and "monitoring technology". The selection focused on studies related to medication adherence monitoring technology and its development and use. The technological features, methods of adherence data capture, and potential advantages and limitations of identified technology applications were extracted. Common, recurring elements were synthesized as potential technology assessment criteria. RESULTS Among 3865 articles retrieved, 98 remained for final review, which reported a variety of technology applications for monitoring medication adherence, including electronic pill bottles/boxes, ingestible sensors, electronic medication management systems, blister pack technology, patient self-report technology, video-based technology, and motion-sensor technology. The most commonly reported technologies included electronic pill bottles, electronic pillboxes, and ingestible sensors. Twenty-eight technology assessment criteria were identified and organized into five categories: Development Information, Technology Features, Medication Adherence Data Collection & Management, Feasibility & Implementation, and Acceptability and Usability. CONCLUSIONS This study summarized the technical features, data capture methods, and various advantages and limitations of medication adherence monitoring technology reported in the literature and proposed criteria for assessing medication adherence monitoring technologies. This collection of assessment criteria may be a useful tool to guide the development and selection of relevant technology, facilitating the optimal adoption and effective use of technology to improve medication adherence outcomes. Future studies are suggested to further validate the medication adherence monitoring technology assessment criteria and construct an appropriate technology evaluation framework.

Communicating Electronic Adherence Data to Physicians—Consensus-Based Development of a Compact Reporting Form

Information on medication adherence is missing in patient files, although it might be helpful to optimize treatment. An adherence report that presents data from electronic adherence monitoring and provides recommendations regarding pharmacological treatment could close this gap. We aimed to develop an adherence reporting form that combines suitable calculations and graphical representations to facilitate the physicians’ interpretation of (non-)adherence. Two consensus development panels were conducted. First, pharmacists with expertise in adherence monitoring debated the items needed to calculate and illustrate electronic adherence data. Second, physicians discussed the items they would need for an adherence report and were encouraged to propose new items. Preference was indicated by raising a green or red card. Voting was repeated until consensus was obtained. Third, first drafts of the adherence reporting form were created by two pharmacists. Seven pharmacists agreed on four metrics to express medication adherence and three graphical representations. Five physicians approved the four metrics and rated the dot chart as the most useful illustration for judging the patient’s adherence patterns. Additionally, they required a clinical–pharmaceutical evaluation of the adherence estimates considering drug-related properties. We developed an adherence reporting form for the first time in a compact format and based on the recommendations of experts. In addition, we considered the preferences of physicians, who appreciated the clarity of the reporting form.

Recommendations for defining and reporting adherence measured by Biometric Monitoring Technologies (BioMeTs): A systematic review (Preprint)

BACKGROUND Sub-optimal adherence to data collection procedures and/or a study intervention is often the cause of a failed clinical trial. Data from biometric monitoring technologies (BioMeTs) can measure adherence to both digital therapeutics and digital data collection procedures, thereby providing the opportunity to identify the determinants of adherence and thereafter, methods to maximize adherence. OBJECTIVE Our goal was to describe the methods and definitions by which adherence has been captured and reported using BioMeTs in recent years. Identifying key gaps allowed us to make recommendations regarding minimum reporting requirements and consistency of definitions for BioMeT-based adherence data. METHODS We conducted a systematic review of studies published between 2014 and 2019 that deployed a BioMeT outside of the clinical/lab setting for which a quantitative, non-surrogate, sensor-based measurement of adherence was reported. After systematically screening manuscripts for eligibility, we extracted details regarding study design, participants, the BioMeT/s used, and the definition and units of adherence. Primary definitions of adherence were categorized as a continuous variable based on duration (highest resolution), a continuous variable based on the number of measurements completed, or a categorical variable (lowest resolution). RESULTS Our PubMed search terms identified 940 manuscripts; 100 met our eligibility criteria, which contained descriptions of 110 BioMeTs. We identified 37 unique definitions of adherence reported for 110 BioMeTs, and observed that the uniformity of adherence definitions was associated with the resolution of the data reported. When adherence was reported as a continuous time-based variable, the same definition of adherence was adopted for 92% of the tools; however, when adherence data were simplified to a categorical variable, we observed 25 unique definitions of adherence reported for 37 tools. CONCLUSIONS We recommend that: A) quantitative, non-surrogate, sensor-based, adherence data be reported for all BioMeTs when feasible; B) a clear description of the sensor/s used to capture adherence data, the algorithm/s that convert sample-level measurements to a metric of adherence, and the analytical validation data demonstrating that BioMeT-generated adherence is an accurate and reliable measurement of actual usage, be provided when available; and C) primary adherence data be reported as a continuous variable followed by categorical definitions if needed, and that the categories adopted are supported by clinical validation data and/or consistent with previous reports.

Implementing the use of objective medication adherence data in routine clinical practice via the digital CFHealthHub platform: situation analysis and strategy development using the theoretical domains framework

Background Preventative inhaled treatments preserve lung function and reduce exacerbations in Cystic Fibrosis (CF). Self-reported adherence to these treatments is over-estimated. An online platform (CFHealthHub) has been developed with patients and clinicians to display real-time objective adherence data from dose-counting nebulisers, so that clinical teams can offer informed treatment support. Methods In this paper, we identify pre-implementation barriers to healthcare practitioners performing two key behaviours: accessing objective adherence data through the website CFHealthHub and discussing medication adherence with patients. We aimed to understand barriers during the pre-implementation phase, so that appropriate strategy could be developed for the scale up of implementing objective adherence data in 19 CF centres. Thirteen semi-structured interviews were conducted with healthcare practitioners working in three UK CF centres. Qualitative data were coded using the Theoretical Domains Framework (TDF), which describes 14 validated domains to implementation behaviour change. Results Analysis indicated that an implementation strategy should address all 14 domains of the TDF to successfully support implementation. Participants did not report routines or habits for using objective adherence data in clinical care. Examples of salient barriers included skills, beliefs in consequences, and social influence and professional roles. The results also affirmed a requirement to address organisational barriers. Relevant behaviour change techniques were selected to develop implementation strategy modules using the behaviour change wheel approach to intervention development. ConclusionsThis paper demonstrates the value of applying the TDF at pre-implementation, to understand context and to support the development of a situationally relevant implementation strategy. Contribution to the literature· Research indicates that the implementation of healthcare innovations may be more likely to succeed when context and theory are taken into consideration. · In this study, healthcare professionals identified barriers to two behaviours that were key to the implementation of a national Cystic Fibrosis (CF) healthcare innovation. By coding barriers to the Theoretical Domains Framework (TDF), a contextually relevant implementation strategy was developed, with a focus on clinician behaviour change. · The study highlights the challenges CF teams face when implementing new remote monitoring of medication adherence, and provides an important opportunity to apply the TDF in the pre-implementation phase of a healthcare innovation.

Real world effectiveness and cost consequences of grass pollen SCIT compared with SLIT and symptomatic treatment

Purpose Real-world evidence (RWE) with regard to allergen-specific immunotherapy (AIT) adherence is increasingly available. Economic modelling has already shown AIT to be cost-effective in the treatment of allergic rhinitis compared with symptomatic treatment. However, analyzing sublingual (SLIT) and subcutaneous (SCIT) immunotherapeutic approaches based on RWE adherence data are not available for Germany. This analysis outlines the cost-effectiveness of SCIT compared with SLIT as well as a symptomatic treatment modality on the basis of recent RWE adherence data. Methods A Markov model, with predefined disease stages and a time period of 9 years, was adapted for this analysis. A 6-grass subcutaneous allergoid SCIT preparation and a 5-grass pollen SLIT tablet was employed as AIT administrations. Quality-adjusted life years (QALYs) were calculated based on symptom scores and used as the effectiveness variable. Total costs and cost effectiveness of SCIT, SLIT and symptomatic treatment (ST) were calculated. Model uncertainties were estimated by means of additional sensitivity analyses. Applied discount rate was 3%. Results Both SCIT and SLIT preparations proved superior compared to symptomatic treatment with regard to effectiveness. Although more expensive, AIT also proved to be cost-effective. A direct comparison of SCIT (Allergovit®) and SLIT (Oralair®) showed lower total costs for SCIT treatment over the study period of 9 years (SCIT 1779 € versus SLIT 2438 €) and improved effectiveness (SCIT 7.17 QALYs versus SLIT 7.11 QALYs). Conclusion AIT represents a cost-effective treatment option for patients with allergic rhinitis compared with symptomatic treatment. SCIT appeared to be dominant and cost-effective, due in particular to higher patient adherence and lower drug costs.

Assessing Medication Adherence Barriers to Short-Term Oral Antibiotic Treatment in Primary Care—Development and Validation of a Self-Report Questionnaire (BIOTICA)

Background: Pharmacists are increasingly involved in strategies to fight antimicrobial resistance by ensuring optimised antibiotic (AB) use, including adherence support. Successful adherence interventions should be tailored to patients’ barriers and validated instruments are needed. This study aimed to identify adherence barriers to AB treatment, develop a self-report questionnaire, and validate it in outpatients. Method: Adherence barriers were identified through a systematic literature search and focus group discussion. Unmodifiable and irrelevant barriers were excluded from further processing. A validation study assessed the questionnaire’s internal reliability and construct validity by comparing the questionnaire’s score with electronically monitored adherence data. Results: A 15-item questionnaire was created. Overall, 68 patients were included in the construct validation analysis (60.3% female). The mean consecutive taking adherence was 88% and the most frequently reported barriers were “worries about side-effects” (37%) and “having swallowing difficulties” (19%). Three items were excluded from the questionnaire, which was supported by an increase of Cronbach’s alpha (0.69 to 0.70). The 12-item version’s score correlated significantly with medication adherence rate (r = −0.34, p < 0.01). Conclusion: The self-report questionnaire is a reliable and valid tool to pre-emptively assess adherence barriers in outpatients prescribed ABs. In the future, appropriate adherence interventions can be matched to barriers and tested in a pilot intervention study.

Compliance and adherence to drug treatment on patients with chronic kidney disease in high prevalence areas of North Central Province, Sri Lanka

Background: Chronic kidney disease that cannot be explained by traditional factors such as hypertension, diabetes mellitus is called chronic kidney disease unexplained etiology. With limited evidence on the success of interventions in enhancing medication adherence, this study was designed to test patient compliance and adherence on taking medication in North Central Province in Sri Lanka.Methods: A cross sectional study was conducted in a selected area of NCP to identify compliance, adherence. Data was collected using an interviewer administered questionnaire by visiting patients at their own residences.Results: A total of 200 people participated in this study. 92.5% of the population was involved in agriculture and 63% worked more than 1 acre of farmland. Among the selected population (74%) were not educated about the side effects of medication. 60.5% had missed taking their medicines during the prescribed time period. The entire population of the study was selected among patients having a monthly income of less than 15,000 Sri Lankan rupees. There was a statistically significant association in missing doses with land extent, patient’s income and stages of the disease.Conclusions: Non adherence and compliance to the medication is common in patients that worked in largely extended lands, were in late stages of the disease and had reduced income. Compliance and Adherence to the medication can be enhanced by proper counseling and improving patient’s knowledge about their medication.