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연구정보

[사회] Addressing sources of bias in the GRAND study protocol in India

인도 국외연구자료 연구보고서 - The Journal of Clinical Hypertension 발간일 : 2024-10-03 등록일 : 2024-10-24 원문링크

We thank Chattopadhyay and Visaria for reading our GeogRaphic And socioecoNomic Distribution of real-world Indian data of home blood pressure monitoring (GRAND) Study protocol manuscript and appreciate the thoughtful insights into sources of bias provided.1 We welcome this opportunity to address the points raised and to clarify our approach.Since India is one of the most diverse countries, there is indeed a variation of options in antihypertensive treatment, access to care, medication adherence, and health literacy among other variables which might significantly affect blood pressure (BP) control and could impact the stability of an antihypertensive regimen across the country. In our protocol, the stability in antihypertensive medications is defined as consistent and continuous use of prescribed antihypertensive medication without changes for at least 3 months. To minimize the variability by those factors, the study investigators were provided with an educational session on proper BP measuring techniques to train the participants. On the other hand, the study participants (1) received training by the study investigator/supporting staff of show-how on home BP measurement procedure, (2) were provided with an infographic sheet on the proper technique to measure BP at home, (3) were provided a link and QR code to a short video on how to measure BP at home. All these actions were taken aiming to enhance health literacy and ensure accurate readings.2 Nevertheless, the source of bias is still a valid point and will be included as a limitation in future publications of the study results.We acknowledge that factors such as diet, physical activity, sleep, and mental health/stress among others significantly influence BP. Our protocol included participants’ background questionnaires that captured several of these lifestyle factors. We agree that external factors like temperature can also affect BP readings, and we have considered stratifying our sample to include diverse geographic regions to account for such variations in future results publications. While 24-h ambulatory BP monitoring offers in-depth insights, its implementation is challenging for a subset of individuals, let alone on a large scale due to resource constraints and the disadvantages of this monitoring.3, 4 However, the influencing factors affecting BP are considered in the study limitation and will be mentioned in future publications of the study results.It is a priority for our study to ensure the study sample is representative of India. We recruited participants across various demographic strata, including religious, geographic, socioeconomic groups among other factors. We have designed our sampling strategy to reflect the diverse Indian population as closely as possible. We emphasize that the study participants are all hypertensive patients under treatment, so the results can only apply to hypertensive patients in the nation. Nonetheless, our approach in sampling the closest representative sample of hypertensive patients across India will help in generating generalizable and applicable results across different segments of Indian society.One additional note to mention is that the sample size of our study population is not considered large compared to India`s population, and there were indeed limitations in our study, however, clinical studies using home BP monitoring (HBPM) in India are limited. Our GRAND Study is the first step toward understanding the “real” BP control status using both clinic BP and home BP and the current hypertension situation in India. We believe that the GRAND Study will contribute to understanding hypertension management based on HBPM, and we anticipate that future national studies in India will also incorporate HBPM.We appreciate the constructive feedback on our protocol. We believe the mentioned insights align well with our goal of providing a comprehensive and accurate assessment of hypertension prevalence and BP control in India. We are committed to incorporating these insights in analyzing the results of the study and in future publications to ensure proper interpretations of the study findings and implications.

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