Exploring the Perspectives,Knowledge and Attitudes Toward the “MASH-Cardiovascular Multidisciplinary Programme” of Subjects With Metabolic Dysfunction-Associated Steatohepatitis: A Qualitative Case Study Protocol

Study Design

This qualitative descriptive study will use semi-structured interviews to collect data, enabling an in-depth exploration of the main study phenomena (perceptions, expectations, attitudes, needs, and knowledge) among patients with MASH participating in the MASH-CVP. This approach allows for a deeper exploration of the meanings and experiences underlying previously obtained quantitative results (Antentas et al., 2026), providing a more comprehensive understanding of the phenomena (Berenguera Ossó, 2014). The semi-structured interview guide will be developed based on the Theoretical Domains Framework (TDF) of behaviour change, which informs the design of questions and supports the exploration of factors influencing the perceptions, attitudes, needs, and knowledge of the patients with MASH, while maintaining an inductive analytic approach (Atkins et al., 2017). The interview questions will follow a flexible structure and will be continuously refined and adapted throughout the data collection process. This approach will allow the incorporation of patients’ perceptions and the exploration of emerging topics of interest based on the responses of the patients, allowing adaptation during data collection to incorporate the perceptions of the patients and respond dynamically to emerging insights. (Malmqvist et al., 2019). (See Supplementary Material). A pilot study will be conducted to assess the clarity, relevance, and feasibility of the material prior to data collection (Kallio et al., 2016). The study protocol has been prospectively registered in the ClinicalTrials.gov database (NCT07188220).

Study Population and Sampling

The study population will consist of patients diagnosed with MASH who meet all the criteria to be referred to the multidisciplinary MASH-CVP at the HSCSP in Barcelona (Antentas et al., 2026). HSCSP is a tertiary-care hospital that provides specialized, multidisciplinary, and coordinated care for patients with MASH, making it particularly relevant for exploring the study phenomena. Recruitment will follow a convenience sampling approach, including patients who meet the clinical eligibility criteria and are accessible and willing to participate. This approach ensures that the data collected are both relevant and informative for the study objectives.

⁃ Inclusion criteria

Study Phases

The study is structured into four distinct phases: 1) pilot study phase, 2) recruitment phase, 3) data collection phase, and 4) data analysis phase (Figure 1).OPEN IN VIEWER

Study Pilot Phase

A pilot study will be conducted to assess the feasibility, clarity, and relevance of the proposed semi-structured interviews and sociodemographic questionnaire among patients enrolled in the MASH-CVP at HSCSP. Four patients will be included: two who are currently starting the programme and two who are completing it. This pilot phase will evaluate whether the interview questions effectively capture the intended qualitative data and are understandable and meaningful to patients (Malmqvist et al., 2019; Thorogood, N, 2018). Furthermore, feedback from patients will be incorporated to co-design and refine the interview guide, ensuring that the questions accurately reflect their lived experiences and perceptions (Malmqvist et al., 2019).

Recruitment Phase

The required sample size for the study will be determined through saturation analysis, with patients being recruited until no new or previously unidentified concepts emerge during the interviews, ensuring comprehensive coverage of the research topic (Berenguera Ossó, 2014). A saturation grid will be developed to track and document the emergence of spontaneously mentioned concepts related to the main study phenomena. This approach will help determine the point at which no new information is generated (Braun & Clarke, 2021). To confirm data saturation, each patient’s responses will be analyzed, coded, and compared against the number of new concepts identified in subsequent interviews (Braun & Clarke, 2021).

Patients who agree to participate in the lifestyle programme for the treatment of MASH-CVP at the HSCSP will be invited to take part in semi-structured interviews. They will be informed that their contribution to this study will help improve the management of the programme and future initiatives aimed at treating MASH.

Data Collection Phase: Semi-structured Interviews

Data will be collected through two semi-structured interviews to explore the main study phenomena (perceptions, expectations, attitudes, needs, and knowledge) of patients with MASH participating in the MASH-CVP. These interviews will provide valuable insights, enabling an objective and in-depth analysis of the phenomena under investigation, as well as patient experiences and socio-demographic information before and after the programme (Thorogood, N, 2018).

The data collection phase will consist of two visits: one at baseline (0 months) and another at 12 months. A pre-selection period will take place prior to the baseline visit to confirm eligibility. If the criteria are met, the baseline visit will be scheduled. At baseline, patients will complete a sociodemographic questionnaire and take part in a semi-structured interview will be conducted one to two weeks prior to programme initiation. The interview will take place in person at the study center (HSCSP) and recorded using an institutional Teams account to ensure privacy (Figure 2).OPEN IN VIEWER

The second interview will take place one to two weeks after programme completion, either in person or online, depending on patient availability. Any changes in socio-demographic information will be recorded and updated during this interview (Figure 2).

Data Analysis Phase

A thematic content analysis will be conducted following the five steps proposed by Graneheim and Lundman (1) verbatim transcription of interviews, (2) thorough review of the transcripts to capture key ideas, (3) identification and coding of units of meaning, (4) grouping of codes into broader categories, and (5) extraction of main themes. All interviews will first be systematically transcribed, after which the research team will carefully read the transcripts to become familiar with the data. Using qualitative analysis software, two researchers will independently code the transcripts according to a pre-established coding framework. This process involves segmenting the text into meaningful units, coding the content, clustering codes into categories, and analysing each category to derive an integrated understanding of the data. Finally, the research team will collectively review and discuss the findings to enhance credibility, consistency, and rigor through triangulation (Berenguera Ossó, 2014). This approach was selected as it enables a systematic yet flexible identification of patterns across the data, allowing for an in-depth exploration of the perceptions and experiences of the patients who participated in the MASH-CVP (Braun & Clarke, 2006).

Ethics

This study will be conducted according to the Helsinki Declaration (World Medical Association, 2013). It has been approved by the research committee of Hospital de Sant Pau on April 23st, 2025, under the code 25/093 (OBS). The interviews will be conducted face-to-face by a dietitian-nutritionist who is not involved in delivering the nutritional intervention offered at the MASH-CVP at the HSCSP, ensuring independence from the clinical team. All interviews will be audio-recorded with the Microsoft Teams platform provided by the University of Vic – Central University of Catalonia. Audio files will be stored on an encrypted institutional server. Recording then will be transcribed verbatim for subsequent qualitative analysis.

Informed consent will be obtained verbally and written, in a face-to-face baseline visit with each patient. Patients will be fully informed about the study objectives, procedures, minimal risks, and potential benefits before giving their consent.

All personal data will be anonymized by assigning a study code to each patient and all patients will be provided with the study information sheet and the informed consent form. The identity of each subject participating in the semi-structured interview will be coded with a unique identifier, ensuring that it cannot be used to identify them under any circumstances. Additionally, the conduct of this study is expected to pose minimal risks to the patients.

Dissemination Strategy

The dissemination plan includes publication in peer-reviewed journals, presentation of findings at scientific conferences, sharing plain language summaries via institutional websites, providing patients with an executive summary of the study results, and posting updates through relevant social media.

Rigor

The rigor of this study will be guided by the criteria of credibility, transferability, dependability, and confirmability proposed by Guba and Lincoln (Guba & Lincoln, 1994). These well-established criteria offer a framework to ensure that the findings are credible, accurately reflect the perceptions of patients with MASH, and are methodologically rigorous.

To achieve these standards, multiple strategies will be employed. First, data triangulation will be conducted to enhance understanding of the complex phenomena under investigation and to capture the perceptions of patients more comprehensively. Following data collection, patients will be invited to review the preliminary interpretations as part of the member-checking process, providing feedback to ensure that the analysis accurately represents their experiences (Korstjens & Moser, 2018).

Reflexivity will be maintained during data collection, analysis, and interpretation, with the researcher position as registered dietitian nutritionist explicitly acknowledged and its influence on the study considered. Specifically, during the semi-structured interviews, the researcher will take brief field notes using a structured template to document non-verbal cues (e.g., facial expressions, tone shifts, pauses), contextual elements (e.g., interruptions), and initial reflexive impressions, which may enrich the interpretation of the data. After each interview, the researcher will expand and clarify these notes, transforming them into detailed field notes and reflexive memos (Korstjens & Moser, 2018; Palaganas et al., 2017). To support transferability, detailed descriptions of the study context, procedures, and patients characteristics will be provided in all publications, facilitating replication (Korstjens & Moser, 2018; Palaganas et al., 2017).

In line with established qualitative research standards, the study will adhere to the Standards for Reporting Qualitative Research (SRQR) (O’Brien et al., 2014; Tong et al., 2012).

Potential Limitations and Challenges

Several potential limitations could be identified in the present study. During the semi-structured interviews, data could be lost due to cultural beliefs or language barriers on the part of patients. Patient dropout is another possible challenge, given the one-year duration of the study and the requirement to complete interviews at both the beginning and the end of the programme. Additionally, there is a potential for selection bias and the risk of recruiting a sample that may not be sufficiently heterogeneous, as HSCSP primarily serves neighborhoods with middle and upper-middle socioeconomic levels in Barcelona. Nevertheless, the sampling strategy profiles and ensures the study captures a diverse range of experiences.