Assessing the Content Validity of a New Patient-Reported Measure of Barriers to Antiretroviral Therapy Adherence for Electronic Administration in Routine HIV Care: Proposal for a Web-Based Delphi Study

Journal of Patient Experience

et al. 2020

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Patient engagement (PE) promotes collaboration between stakeholders (researchers, patients, clinicians, etc). It often faces challenges due to tensions between its ethical/political and scientific underpinnings. This article explores how stakeholders applied the guiding principles of a PE project (“co-build,” “support and mutual respect,” and “inclusiveness”) for an HIV clinical research program initiated in January 2016. Three researchers/clinicians, a PE agent, and 2 patients held 3 meetings (June-October 2018) to discuss challenges faced and how these impacted their approach to PE. Regular stakeholder discussions about PE in clinical research could be documented and help guide PE to better meet stakeholder needs.

Section: Resultsmentioning

confidence: 99%

Challenges of Patient Engagement in an HIV Clinical Research Program: A Qualitative Analysis of Stakeholder Accounts

Lessard

Journal of Patient Experience

et al. 2020

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“…Systematic monitoring of patient-reported adherence barriers could allow for a more preventative approach and help ensure adherence management addresses patients’ priorities. Indeed, the I-Score PROM includes only the most highly valued barriers in terms of relevance and importance to HIV care, as rated by people living with HIV and providers in our Delphi consultation [ 42 ]. As to the app through which the PROM is administered and its features, it may help redress the patient-provider knowledge imbalance and empower patients in their care [ 71 ].…”

Section: Discussionmentioning

confidence: 99%

“…Respondents indicate how often each barrier made adherence difficult in the past 4 weeks, with an 11-point scale, from 0% (never made it difficult) to 100% (always made it difficult). Details on the measure’s development are published elsewhere [ 20 , 23 , 24 , 42 ]. Example items include “I was not motivated to take my medication,” “I felt isolated or alone,” “I had another health condition to deal with (for example, depression, diabetes, or heart disease),” and “My medication cost coverage was not sufficient.”…”

Section: Methodsmentioning

confidence: 99%

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Implementation of an electronic patient-reported measure of barriers to antiretroviral therapy adherence with the Opal patient portal: Protocol for a mixed method type 3 hybrid pilot study at a large Montreal HIV clinic

et al. 2021

PLoS ONE

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Background Adherence to antiretroviral therapy (ART) remains problematic. Regular monitoring of its barriers is clinically recommended, however, patient-provider communication around adherence is often inadequate. Our team thus decided to develop a new electronically administered patient-reported outcome measure (PROM) of barriers to ART adherence (the I-Score) to systematically capture this data for physician consideration in routine HIV care. To prepare for a controlled definitive trial to test the I-Score intervention, a pilot study was designed. Its primary objectives are to evaluate patient and physician perceptions of the I-Score intervention and its implementation strategy. Methods This one-arm, 6-month study will adopt a mixed method type 3 implementation-effectiveness hybrid design and be conducted at the Chronic Viral Illness Service of the McGill University Health Centre (Montreal, Canada). Four HIV physicians and 32 of their HIV patients with known or suspected adherence problems will participate. The intervention will involve having patients complete the I-Score through a smartphone application (Opal), before meeting with their physician. Both patients and physicians will have access to the I-Score results, for consideration during the clinic visits at Times 1, 2 (3 months), and 3 (6 months). The implementation strategy will focus on stakeholder involvement, education, and training; promoting the intervention’s adaptability; and hiring an Application Manager to facilitate implementation. Implementation, patient, and service outcomes will be collected (Times 1-2-3). The primary outcome is the intervention’s acceptability to patients and physicians. Qualitative data obtained, in part, through physician focus groups (Times 2–3) and patient interviews (Times 2–3) will help evaluate the implementation strategy and inform any methodological adaptations. Discussion This study will help plan a definitive trial to test the efficacy of the I-Score intervention. It will generate needed data on electronic PROM interventions in routine HIV care that will help improve understanding of conditions for their successful implementation. Clinical trial registration ClinicalTrials.gov identifier: NCT04702412; https://clinicaltrials.gov/.

“…To reduce and evaluate the content validity of the 100 items, a modified Delphi was conducted with a panel of PLHIV and health and social service providers in Canada and France (for full methodological details see [ 16 ]). This step as well as our other stakeholder engagement activities [ 17 , 18 ] recognize that a PROM’s content validity is crucial [ 19 ] and, when seeking PROM implementation in care, so is involving both patients and clinicians in their development [ 20 ].…”

Section: Introductionmentioning

confidence: 99%

Content validation of a new measure of patient-reported barriers to antiretroviral therapy adherence, the I-Score: results from a Delphi study

Mate

et al. 2022

J Patient Rep Outcomes

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Background Over a third of people living with HIV (PLHIV) have suboptimal adherence to antiretroviral therapy (ART). Measures of barriers to ART adherence often lack comprehensiveness. To help manage ART adherence barriers in HIV care, we are developing a new patient-reported outcome measure (PROM) of these barriers (the I-Score). Methods We assessed the content validity of 100 items (distinct barriers) to retain only those most relevant to both PLHIV and HIV health/social service providers. A web-based Delphi was conducted in Canada and France, collecting data from December 2018 to October 2019. Items were evaluated on relevance (the combined rated importance and actionability for HIV care of items among both PLHIV and providers); comprehensibility (rated item clarity); comprehensiveness (examined against our conceptual framework); cross-cultural equivalence (based on comparisons by questionnaire language (English, French) and country of residence). Pearson’s chi-square tests were used for comparisons by language, country, gender, and stakeholder group (PLHIV, providers). Results Panelists included 40 PLHIV and 57 providers (66% response rate). Thirty-one items were retained based on consensus thresholds for relevance (minimum: 50% for PLHIV, 60% for providers) and showed good comprehensibility and comprehensiveness, when compared to our conceptual framework (representation of: 6/6 domains, 15/20 subdomains). No significant difference in relevance based on language or country was found among retained items, suggestive of cross-cultural equivalence. Among all 100 items, only 6 significant differences on relevance were observed for gender. For 62 items, the relevance ratings of PLHIV and providers differed significantly, with providers showing greater endorsement of all items but one. Discussion The Delphi led to a much-needed item reduction. Remaining items highlight the panel’s multidimensional priorities for the PROM on ART adherence barriers, with few, if any, differences by language, country, and gender. While the analyses may lack generalizability and power, the sample size is considered adequate for a PROM validation study. Conclusion Retained items showed good content validity. The different patterns of item endorsement observed underscore the utility of engaging multiple stakeholder groups in PROM development for use in clinical practice. The greater endorsement of items by providers versus patients merits further investigation, including the implications of such differentials for measure development.