Improving Assessment of Adherence Behaviors and Drivers: Targeted Literature Review and Concept Elicitation Interviews in Multiple Countries and Disease Populations.

Purpose: Medication adherence is crucial for achieving clinical goals. Medication adherence drivers and behaviors were explored across multiple conditions, countries, and medication schedules/modalities to develop a conceptual model of medication adherence, which could later be used to support development of a patient-reported outcome (PRO) measure of adherence. Patients and Methods: Targeted review of qualitative literature identified important medication adherence concepts. Fifty-seven qualitative concept elicitation interviews were conducted (USA n=21, Spain n=18, Germany n=18). Participants were prescribed medication for: hypertension (n=9), asthma (n=8), multiple myeloma (n=8), psoriasis (n=8), diabetes (n=7), depression (n=7), multiple sclerosis (n=7), and/or schizophrenia (n=6). Thematic analysis of verbatim transcripts was performed. Expert clinicians (n=3) provided input throughout. Results: Nine qualitative articles were selected for review from 2168 screened abstracts. Forty-two medication adherence concepts were reported and grouped into 10 domains. Eight forms of medication adherence were reported during interviews, along with 27 drivers of non-adherence, all of which were incorporated into a conceptual model. Participants reported skipping medication doses (n=36/57; 63.2%) or taking medication later in the day than prescribed (n=29/57; 50.9%). Common drivers of non-adherence included forgetfulness (n=35/57; 61.4%), being out of the usual routine (n=31/57; 54.4%) and being busy (n=22/57; 38.6%). US participants were more likely to report non-adherence due to low perceived efficacy (n=6/21, 28.6%) and cost (n=5/21, 23.8%) than German (n=1/18, 5.6%; n=0/18, 0.0%) or Spanish (n=2/18, 11.1%; n=1/18, 5.6%) participants. Conclusion: Findings highlight the diverse forms and drivers of medication non-adherence, informing the development of a comprehensive conceptual model of medication adherence. The conceptual model builds on and advances previous models of medication adherence and can be used by healthcare professionals to understand and interpret barriers to medication adherence and how best to support patients in taking their medication as intended.

Medication adherence is the extent to which a patient takes their medication as prescribed. This paper describes a literature review and concept elicitation interviews to identify forms and drivers of medication adherence across a diverse sample of participants. Forms of non-adherence identified included: deviating from the prescription, skipping a dose, taking a different amount, and taking medication at a different time. Behaviours and drivers can vary by condition, treatment modality, and dosing schedule.This research highlights the variation in the prevalence of medication non-adherence, and the different forms and drivers of non-adherence, based on individuals' demographic and clinical characteristics. The conceptual model developed advances previous models of medication adherence and may support healthcare professionals in the management of patients and how they can be supported to take medication as intended. The research ultimately informed the development of the Adelphi Adherence Questionnaire (ADAQ^©), a novel generic patient-reported outcome measure.

Content validity of the EORTC quality of life questionnaire QLQ-C30 for use in cancer.

AIM: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) is among the most widely used patient-reported outcome measures in cancer research and practice. It was developed prior to guidance that content should be established directly from patients to confirm it measures concepts of interest and is appropriate and comprehensive for the intended population. This study evaluated the content validity of the QLQ-C30 for use with cancer patients. METHODS: Adults undergoing cancer treatment in Europe and the USA participated in open-ended concept elicitation interviews regarding their functional health, symptoms, side-effects and impacts on health-related quality of life. Thematic analysis was conducted, and similarities across cancer types, disease stages and countries or languages were explored. RESULTS: Interviews with 113 patients with cancer (85 European, 28 USA) including breast, lung, prostate, colorectal and other cancers were conducted between 2016 and 2020. Conceptual saturation was achieved. The most frequently reported concepts were included in the QLQ-C30 conceptual framework. QLQ-C30 items were widely understood across language versions and were relevant to patients across cancer types and disease stages. While several new concepts were elicited such as difficulty climbing steps or stairs, weight loss, skin problems and numbness, many were not widely experienced and/or could be considered sub-concepts of existing concepts. CONCLUSIONS: The QLQ-C30 demonstrates good evidence of content validity for the assessment of functional health, symptom burden and health-related quality of life in patients with localised-to-advanced cancer.

Qualitative Interviews to Support Development and Cognitive Debriefing of the Adelphi Adherence Questionnaire (ADAQ©): A Patient-Reported Measure of Medication Adherence Developed for Use in a Range of Diseases, Treatment Modalities, and Countries.

Purpose: The Adelphi Adherence Questionnaire (ADAQ©) is a newly developed generic patient-reported outcome (PRO) assessment of medication adherence. The aim was to assess its content validity by conducting cognitive debriefing (CD) interviews with patients prescribed medication(s) of various treatment modalities in a range of therapy areas. Materials and Methods: Targeted literature/instrument review and concept elicitation interviews informed development of the ADAQ©. CD interviews were conducted with 57 adults from the United States of America (USA; n = 21), Spain (n = 18), and Germany (n = 18) who prescribed medication for hypertension, diabetes, depression, schizophrenia, asthma, multiple myeloma, psoriasis, and/or multiple sclerosis. Interviews were conducted in two rounds to explore the relevance and understanding of the item wording, instructions, recall period and response options. Verbatim transcripts were analysed in ATLAS.Ti using thematic analysis. Three expert clinicians provided guidance throughout the study. Results: ADAQ© items/instructions were well understood and relevant to participants. Key modifications following round 1 included revising instructions to refer to current medication(s) for one condition to reduce cognitive burden, removing two items with lower relevance (specifically those assessing running out of medication and social discouragement), and adding a response option for participants to indicate if they had stopped taking a medication. Minor wording modifications were made following round 2. Subgroup differences in item relevance were explored based on clinical characteristics. Cost of medication was more relevant amongst US participants. Conclusion: Content validity of the ADAQ© was confirmed in demographically and clinically diverse participants. Psychometric properties of the ADAQ© will be explored in future studies.

Improving patient-clinician communication following nephrectomy in renal cell carcinoma: Development, content validation and pilot testing of a conversation aid tool.

OBJECTIVES: This study developed, and established the content validity, of a conversation aid tool (CAT) for use in clinical practice with renal cell carcinoma (RCC) patients who receive a curative nephrectomy and are at high-risk of recurrence. The CAT was pilot tested in a sample of RCC patients to establish whether the CAT increases knowledge of RCC, treatment options (such as adjuvant therapy), and care options. METHODS: A cross-sectional, mixed methods design was used involving initial, exploratory interviews with RCC patients, RCC specialists and a steering group. Further content validation interviews were conducted with RCC patients and specialists. A web-based survey was conducted with RCC patients (N = 60), to compare the CAT versus a standard of care (SOC) consultation comparator tool on patient knowledge. RESULTS: Findings from exploratory interviews were used to develop the CAT. Content validation interviews demonstrated that the CAT was well understood and relevant to RCC patients. The web-based survey demonstrated that viewing the CAT significantly improved participants knowledge of RCC, and care options, when compared to the SOC. CONCLUSION: The findings highlight that the CAT is a relevant, comprehensive and well-understood tool for use in the post-nephrectomy consultation. PRACTICE IMPLICATIONS: Use of the CAT may increase patient knowledge of RCC and care options.