JMIR Publications

ABSTRACT

Background:

In developed countries, only 50% of the patients treated for chronic diseases adhere to the prescribed treatment and the problem in developing countries is greater. Medication adherence scales are simple, low-cost approaches to identify non-adherence in clinical practice. In India non-adherence to medication varies from 18.7% to 74% which is assessed using scales validated in the Western population as we do not have a validated medication adherence tool contextualized to the Indian setting. The phrasing of questions in scales validated elsewhere and its interpretations may vary when applied in the Indian patients unless accounted for unique cultural, social, and economic factors influencing medication adherence in India. This could result in inaccurate reports of adherence behavior.

Objective:

The present study aims to develop and validate a novel medication adherence tool for select NCDs (DM, HTN, COPD/Bronchial asthma, CAD) in the Indian population.

Methods:

Exploratory sequential mixed method design would be used. Item generation would be conceptualized based on deductive process (scoping review) and inductive process (FGD, IDI). Content validity assessment, cognitive interviews, item reduction, expert panel review and cross-sectional survey in 4 zones of India would be used to develop and validate the tool.

Results:

In the first phase, we will develop an inventory of potential items for the proposed medication adherence tool and compute item-level and scale-level content validity indices, along with the content validity ratio. In the second phase, we will conduct item reduction analysis and determine the scoring matrix and item weightage after expert review. In the third phase, we will assess the tool's psychometric properties, plot the ROC curve to set an adherence cutoff score, and compute construct validity and test-retest reliability.

Conclusions:

A medication adherence tool for select NCDs, developed after ensuring it is ethnically, culturally, and linguistically appropriate after exploration of expert opinion and patients’ perspectives and validated in community settings, would offer a real-world perspective of adherence. The tool will have two versions for clinical practice and research, aiding policymakers in adopting tailored adherence policies.