Adherence to pharmacological therapy in patients with hypertension: protocol of a qualitative study by focus groups

Introduction

Hypertension is the leading modifiable risk factor for cardiovascular disease and is a significant contributor to morbidity and mortality globally.1 Despite the high prevalence of hypertension, there is a disparity concerning both its prevalence and control.2–4 One relevant factor contributing to inadequate blood pressure control is non-adherence to antihypertensive medication,5 6 which is estimated at 45% globally.7

Additionally, the hypertensive population typically consists of elderly individuals,8 with low socioeconomic status, a low education level9 and multimorbidity.10 This scenario worsens as multimorbidity contributes to the increase in medical expenses among the elderly.11

Non-adherence can be used as a strategy to deal with such expenses but subsequently increases patients’ risks.11

Increasing adherence to therapeutic recommendations is thought to be a promissory health measure12 and several strategies to improve medication adherence have been tested in randomised controlled trials.13–20 On the other hand, regarding non-pharmacological interventions to improve medication adherence, the question remains of which interventions yield the highest efficacy.21

Understanding the perspectives of patients and healthcare professionals can be valuable for designing strategies to enhance medication adherence. Few studies have been conducted to comprehend the perspectives, attitudes and beliefs of patients22 and healthcare professionals23 concerning medication adherence. None of them focused on adherence to pharmacological therapy for hypertension specifically in Portugal.

When addressing interventions for medication adherence, clinicians and researchers should attend to the characteristics of their unique population, healthcare system, healthcare providers, social policy and community.24 These factors may differ from other countries/cultures. Hence, it is expected that barriers and strategies to address them are also location-specific.25

All this evidence emphasises the need for healthcare providers and policymakers in each location to identify and address the barriers to antihypertensive medications through the development of tailored tactics.25

Objectives

The primary objective of this study will be to investigate the perspectives of patients diagnosed with hypertension and healthcare professionals such as family doctors, nurses and community pharmacists from Portugal regarding the most effective strategies to enhance medication adherence.

Another objective of this study is to gain an understanding of the factors contributing to non-adherence to hypertensive medication in Portugal.

Methods and analysisDesign

This will be a qualitative study. We will organise three synchronous online focus groups26 comprising patients and another three similar focus groups with healthcare professionals. The duration of each session is expected to be of 1 hour.

The participants’ numbers for each focus group will range from 6 to 10 individuals.27–29 The precise number of focus groups required will be determined based on the achievement of theoretical saturation.28 30 31

The facilitator of the focus groups will be a female medical doctor and researcher (BR-S) who has experience in conducting interviews.

The videoconferencing application Zoom will be used to enable the involvement of participants residing in diverse regions of Portugal. The researchers involved in this study did not have prior acquaintance with the participants recruited.

Participants will sign informed consent to participate in the study, to the use of their data and opinions in the focus groups, as well as to their audio-recording, and will be informed that they can withdraw from the study at any time.

The focus group meetings with healthcare professionals will be scheduled in December 2023. We will start the analyses of the data retrieved in January 2024.

In relation to the focus group with patients, the recruitment phase will begin in December 2023. The first focus groups will be pilot studies, and necessary changes will be made to improve the scripts and the following gatherings.

In the development of this protocol, the principles of qualitative research design by focus groups were considered, through criteria and standards of quality and transparency already defined: COnsolidated criteria for REporting Qualitative research32 and Standards for Reporting Qualitative Research.33

Setting and participants

The focus groups will be composed of maximal variation sampling (purposive sample), in which diverse individuals who are expected to hold different perspectives are chosen, based on predefined inclusion criteria (table 1), and invited to participate.34

Table 1

Inclusion criteria

The focus groups with patients with hypertension will include adult patients with hypertension taking at least one antihypertensive drug from the primary care setting and the nomination of potential patients will include criteria28 listed in table 1.

Clinicians will exclude patients who are unable to participate due to cognitive impairment and participants without an email account or whose caregivers or family members do not have an email account.

The promotion of patient focus groups will be through profession-specific mailing lists of family physicians. Among the family doctors willing to collaborate, 15 will be accepted.

Family physicians accepted will be asked to identify and nominate potential participants among their patients with hypertension, regarding their will to participate, and address the need and possibility for assistance from any family member or caregiver to handle the technological requirements of the meeting. Clinicians will address potential participants in the most convenient way (during consultations or via email or telephone) and seek consent from their patients to be contacted (via email or telephone) by the research team.

After obtaining consent to contact, a research team member will contact the participants and give them a concise overview of the study, while addressing any questions they may have. If the person remains interested in participating in the study, a consent form will be sent via email. Each family physician will recruit a maximum of two participants.

The additional three focus groups will gather family physicians, nurses and community pharmacists, and their inclusion criteria are presented in table 1.

Healthcare professionals will be invited to participate through profession-specific mailing lists, and those who reply showing interest in participating will receive more details about the study and, if selected to participate, will receive a copy of the participant consent form via email.

During the process of selecting participants for the focus groups, it will be given priority to participants’ availability for each meeting date and time.

After generating a pool of potential participants, randomisation of potential participants will be made to minimise selection bias using a random number generator.

The consent form sheet will explain the purpose and ethical safeguards of the study. Researchers will gather signed consent forms from participants who maintain their will to participate before the meetings via email.

Additionally, prior to the focus group meeting, the research team will approach participants to thank them for their availability, to ensure that participants understand the purpose of the research and to check the technological conditions to participate in the focus group.

Data collection

Data collection will be carried out during the focus groups which will be recorded via Zoom.

Each group of participants will be of the same category (patients or healthcare professionals) to maintain homogeneity,28 minimising the dynamics of power in the meetings.

The moderator (BR-S) will explain the purpose of the study and after an initial icebreaker activity will introduce the questions, promote the discussion and strive to maintain neutrality while ensuring an interactive atmosphere and contributions from every participant.

The scripts to be used were developed after a thorough review of the existing literature and were revised by two researchers with expertise in focus group moderation. Furthermore, each script underwent a linguistic validation process through cognitive interviews, which involved 10 persons from each target population of the focus groups: 10 patients with hypertension and 10 healthcare professionals from a Primary Healthcare Unit before conducting focus groups. These validations introduced small differences in each script to make them more understandable to the target population.

Each script consists of 10 open-ended questions and the primary subjects approached in the scripts will concentrate on the following areas: the definition of hypertension and adherence to hypertensive medication; the reasons or circumstances leading to patient non-adherence to medication; forgetfulness regarding medication; the factors impeding adherence to prescribed medication; the facilitating factors and strategies aimed at helping patients in adhering to medication; and the significant side effects experienced by patients and methods to reduce or prevent them. Additionally, the role of the family in hypertensive management and the involvement of primary healthcare, pharmacies and technology in promoting adherence to pharmacological therapy will be explored.

Participants will be encouraged to engage in group discussions and share their views and experiences regarding the topics of interest.

At the end of the focus group session, the moderator will undertake a summary, and a research assistant and all participants will be encouraged to express their opinions regarding the summary content.

Attendance in the meetings will be limited to participants and the research team, which will include the moderator (BR-S) and the assistant moderator (IR). Researchers will make field notes during or after the sessions whenever they think it is appropriate. Meetings will be transcribed verbatim with all identifiable information removed from the transcription and replaced by a code number prior to data analyses, and subsequently, the recordings of the sessions will be destroyed, to ensure anonymisation.

Supplementary demographic data regarding participants will be gathered via an online anonymous form distributed after the focus groups. This form will encompass various fields designed to capture the following information: age, sex, place of residence, type of geographical location, household composition, educational level, occupation, number of pills taken daily (only for patients) and prior involvement in focus groups, as well as an open section for participants to provide additional comments or suggestions.

Data analyses

The transcribed data will undergo qualitative analyses using the MAXQDA V.12 software program during the period from July 2023 to September 2023.

Two researchers will assess the data through comparative analyses and subsequent consensus.

The information will be categorised and subjected to content analyses to construct a coding tree and identify the primary themes, predominantly aligning with the script questions. In the beginning, category definition and abstraction level will be defined, but both deductive and inductive category development approaches will be employed. A third researcher will review the analyses. The results will be presented narratively, accompanied by illustrative quotations from the data.28 29 35

Patient and public involvement statement

None.

Data protection

The research team will keep all confidential data for 5 years, storing it exclusively on password-protected computers that are only accessible to team members. Before conducting data analyses, the audio recordings will undergo anonymisation, ensuring the removal of any identifiable information.

Ethics and dissemination

Written informed consent to participate and be audio-recorded will be obtained from all participants.

The Ethics Committee of the University of Coimbra has approved this study with the number CE-026/2021, which adheres to the Declaration of Helsinki.

This study has been designed to obtain insights and feedback about reasons for non-adherence, and strategies to improve adherence to medication in patients with hypertension to conduct subsequent research to develop and test strategies to address adherence to medication in patients with hypertension. Additionally, these findings will be disseminated via peer-reviewed publications and national and international conferences.

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