Theoretical framework

The main tenets of the theory of critical realism will be used to guide this study. Critical realism accounts for individual factors and structural factors that influence dietary decision-making.52 Individual factors include participants’ knowledge, beliefs and attitudes; whereas structural factors include gender, culture, social norms, and the political and geographical environments.10 ,52 Critical realism is derived mainly from the philosophy of Bhaskar,53 who argued that the purpose of science is to describe social phenomena in a way that makes sense to us and not just to seek the absolute truth as in experiments.52^–54 Critical realism stratifies reality and suggests that reality is influenced by various elements, objects, practices and structures. It has three domains: “(1) the empirical—which are experienced and perceived, (2) the actual—actions that can be observed, and (3) the real—underlying structures, powers and tendencies which cause events in an actual domain.”52 These domains identify the underlying structures, powers or forces that influence people's behaviour or way of living, even though they might not be aware of them. Thus, critical realism focuses on explaining the outcomes as they occur in complex and natural environments.

The theory also helps us to understand the broader social structures such as poverty, sex, race and so on that exist in society and influence behaviour.52 People cannot deny the existence of these social realities just because they do not recognise or perceive them as factors that affect their behaviours or actively influence their lifestyle patterns.55 The way that people live can be understood in complex natural settings in which multiple factors act together to form behaviour. Some of these factors are physical, social, cultural, economical, environmental and geographical.55 In summary, critical realism offers a comprehensive approach that explains the outcomes in real and complex environments. It explores the influences of the underlying powers and structures that the participants might not have perceived as barriers in selecting a healthy diet.

Study setting

This study will take place in Karachi, the largest metropolitan city of Pakistan, which has a population of approximately 18–20 million.56 Many ethnolinguistic groups from all parts of Pakistan reside in Karachi, and most of the people in Karachi are of low-income and middle-income groups. The main causes of death for adults are CVD, injuries and complications from pregnancy.57 We aim to recruit participants mainly from CR centres or any other cardiac facilities of the two large hospitals in Karachi, where people with low-SES receive rehabilitative services free of charge. One rehabilitation centre is at Aga Khan University Hospital (AKUH), and the other centre is located at the National Institute of Cardiovascular Diseases (NICVD). Both centres provide 2–4 weeks of comprehensive services, which include education, prescribed exercise, nutritional counselling and other behavioural interventions.58

NICVD was established in 1963 to meet the national need to cope with the increasing demand for diagnosis, management and prevention of CVDs. The institution provides diagnostic, preventive care and medical services to all patients free of charge. Most people from low-SES from all parts of Pakistan are referred to NICVD for the diagnosis and treatment of CVDs. The daily out-patient attendance averages 1200 individuals, and an average of 30–40 patients attend rehabilitation services.59 ,60

AKUH started its operation in 1985. It is a not-for-profit, private teaching institution committed to providing the best possible options for the diagnosis and management of all diseases for all patients. Although AKUH is a private institution, it provides financial assistance to needy and poor patients who cannot bear the cost of medical treatment and rehabilitative services. AKUH's Department of Patients’ Welfare is responsible for screening patients’ needs and providing financial assistance accordingly.61

Study sample

We anticipate that 25–30 participants, 12–15 from each facility, will be sufficient to provide us with meaningful descriptions to answer the above research questions. Hunt47 used 18 participants to investigate the ‘moral experience of Canadian healthcare professionals in humanitarian work’ and achieved sufficient depth and meaningful description. Hunt further explained that purposive sampling results in a diverse set of participants, and theoretical sampling achieves richness in understanding the issues “identified in the early analysis of the data, or who could address aspects of the inquiry that remained underdeveloped or thin.”47 We will recruit participants who have financial assistance at any cardiac facility of AKUH and include participants from NICVD if they earn $C1.25 (Rs.113) or less, based on the poverty line defined by Pakistan's economic analysis.62 We will purposively and theoretically select participants to capture expected and emerging data variations. Purposive sampling will include participants who represent different age groups, men and women, different ethnicities, those with different educational and income levels and those who are willing to share their decision-making process on food choices; whereas theoretical sampling will involve participants based on information that emerges from an early data analysis. Recruitment of patients from the private and public healthcare settings will also yield maximum variation in sampling.

Inclusion criteria

The participants in this study will include adult patients with CVD who (A) are aged 30–70 years with a documented CVD diagnosis. As mentioned earlier, the onset of CVD in South Asian population occurs at a younger age. People younger than 40 years have also developed heart disease because of the high prevalence of all risk factors at a younger age25; (B) have attended any kind of CR programme or been taught secondary prevention; (C) earn $C1.25 (Rs113) or less per day based on the poverty line defined by Pakistan's economic analysis (self-reported); (D) are of any ethnic group or religion; (E) are able to speak English or Urdu (the national language of Pakistan) and (F) are willing to talk about and reflect on their experiences with the phenomenon under study.

Recruitment process

We will recruit participants by word of mouth and briefly explain (in Urdu) this study during the rehabilitation sessions. We will also request that the staffs who work in the clinics identify eligible participants and obtain their contact numbers or email addresses. The primary author will contact the potential participants by telephone or email. During the initial conversation or meeting she will ensure that each individual meets the inclusion criteria and will arrange times and places for the interviews that are suitable to the participants. Otherwise, she will interview them in one of the offices that AKUH or NICVD will make available to her.

Data collection

Data analysis

The data collection and analysis will occur concurrently. Soon after each interview, the primary author will transcribe the recording verbatim and then code the transcript to reveal broad or initial categories or themes. She will also maintain field notes immediately after each meeting that will include her reflections on the interview process, the participants’ non-verbal behaviours and the initial themes that emerge from the interviews. The transcripts will then be analysed and discussed with the research team, and the data will be examined for similarities and differences in patterns to understand and gain insight into the phenomenon in the participants’ context.

To manage the participants’ data, we will use ATLAS.ti Scientific Development Software, which facilitates the organisation of the data and arrangement of the datasets at different levels of the analytic scheme.65 We will also critically examine the data for underlying structures that the participants might not perceive as barriers to healthy eating.

The final analysis will thus convey the entire essence of individual and contextual factors that influence the participants’ dietary decision-making. We will discuss the themes and categories in the final stage with the research team members, who are subject-expert health professionals. Verification and discussion of the themes with the experts will also ensure that the analysis of the data reflects the participants’ views, makes sense and will be useful in the practice setting.

Thorne46 suggested that the findings should create a platform for assessment, planning and interventional strategies that can be logically and ethically applied in clinical settings.46 We anticipate that this study's findings will lead to the careful and systematic analysis of the contextual and individual factors that influence the participants’ healthy eating and will simultaneously allow me to use that analysis in assessment, planning and interventional strategies in the practice field. Table 1 summarises the analytical steps.

Strategies to ensure the rigour of the study

To ensure the quality and rigour of the study, we the researchers will be deeply involved with the data (eg, transcribing, reading and rereading the transcripts; conducting an inductive analysis) and will maintain transparency while subjectively analysing the data. We are aware of social structures, power relations and gender influences in Pakistan and will, therefore, explicitly acknowledge any personal biases that could influence the research findings.

Thorne46 suggested some guiding principles to ensure the quality of the findings that result from the use of the ID method, and we will apply these principles throughout the entire research process. These principles are as follows:

1. Epistemological integrity is achieved by ensuring the logical flow of the research questions, data sources and data interpretation.

2. Variant sampling will include a broad age range, males and females, diverse ethnic backgrounds and samples from two different rehabilitation centres to help us to gain substantive knowledge of the phenomenon that cannot be produced simply by selecting similar patients from similar backgrounds. Prolonged engagement with the data and a review of prior literature can result in representative credibility and substantive completeness.

3. We will use Miles and Huberman's66 approach for data analysis, which requires an explicit description of the researcher's analytical thinking. We will describe the decision-making process while developing the initial and final themes. This also allows novice researchers to learn the practical application of analytic structures and assists in replicating the research process should other researchers want to repeat it. We will remain vigilant throughout the analytic process and will not attempt premature closure of our early conceptualisations. This will help us to articulate and contextualise specific analytic decisions within the larger picture to reflect analytic logic.

4. Thorne46 defined interpretive authority as the transparent presentation in the research report of the power relation, the subjective construction of knowledge and the researcher's position in the study. This principle emphasises the researcher's trustworthiness in interpreting the data.46 Therefore, as researchers, we will explicitly identify any personal biases and power relations and take ownership of the interpretation and findings from the data.

Synonymous with the goals of the paradigm, ID does not aim for generalisability of the findings; however, the commonality of the patterns that we identify in the study might help to generalise the findings within the context and the time.46 This study will foster a deeper understanding of the complexities of the health-promoting eating behaviours of poor people with CVD. The knowledge gained from this study will provide a more complete picture of its ground realities, facilitate the design of comprehensive preventive interventions for CVD in the context of low-SES and inform future research and national health policy development for required programmatic and structural changes to promote healthy eating. Communities will also be able to draw on the study's findings to make the necessary changes in their own environments to facilitate changes in their shared eating habits. In Pakistan, tertiary care for the management of CVD receives a great deal of emphasis, but it is very costly for the poor. The promotion of primary and secondary preventive programmes is critical for the country to overcome the burden of CVD in a cost-effective manner.

Information letter and consent

The author submitted an information letter to satisfy the informed-consent standards and a separate permission letter to appropriate management teams at the selected field sites. The letter is also written in Urdu for participants who do not understand English. When necessary, we will offer information about the study and the consent procedures verbally in Urdu. The information letter includes details on voluntary participation in the study, the potential benefits and potential harm from participation in the study and the right to withdraw from the study at any time without penalty. We will maintain the participants’ anonymity and confidentially throughout the research process and during the dissemination and publication of the findings. We will ask the participants to sign or place a thumb impression on the consent form.

We will keep the raw data and all identifying information in a separate locked cabinet and the soft copies in encrypted computers. Other than the research team, no one will have access to the participants’ data. When we present the study's findings, we will use pseudonyms to protect the participants’ identities. We will also maintain their anonymity during the tape recording and transcribing, translating and analysing of the data. We will keep the data for 5 years as per the University of Alberta's policy and will electronically erase the data from the audiotapes and shred the hard copies of the transcripts and analysis in a confidential shredder.

Monetary compensation

At the end of the first interview, we will give each participant Rs.250 (approximately $C2.5) as a token of thanks for their participation. We will not ask any participants who wish to withdraw from the second interview to return the money.

Gender implications

As we discussed earlier, Pakistan is a patriarchal society in which women are primarily responsible for all household chores and men are considered breadwinners responsible for the household earnings. With limited resources, the female family members usually select and prepare the food. It is also customary that family practices determine the food to be eaten and that all family members eat the same food prepared in the house. Thus, acceptable cultural norms and resource constraints limit separate food preparation and food selection for patients with CVD. Because the onset of CVD in women tends to occur at a later age when there are more age-related comorbid issues, the management of CVDs and secondary prevention becomes more challenging and complex.16 The findings of this study will categorise the difficulties that strict gender roles present for healthy eating and identify gender-specific approaches for prevention and counselling. The study results will also identify the resource constraints that female family members face in making food choices for their families, as well as identify the limitations of any family.

Communication of findings and knowledge transfer plans

A multilevel knowledge translation plan is created to ensure that key messages are developed for specific audiences.67 The principal audience for this project is the rehabilitation centre staff members at AKUH and NICVD. In the monthly staff meetings, we also intend to share our progress and the results with the physicians, nurses, nutritionists and other rehabilitation staff of AKUH and NICVD. This strategy will create awareness of the context-rich data and may lead to the implementation of necessary changes regarding dietary counselling and preventive measures. We the research team will make presentations at AKUH and NICVD rehabilitation centres to identify critical areas for future research. We will also share the findings with the participants and the family members to provide them with a deeper contextual understanding of the issues regarding the prevention of CVD. Participants may acknowledge the need for changing lifestyles and suggest strategies to incorporate into future preventive programmes. Healthcare teams can work very closely with all family members and address their concerns related to the family's norms and cultural values that influence the patient's lifestyle changes.

The target audience also includes administrators, clinical educators and health policymakers to inform them about preventive measures that require broader programmatic and structural changes to provide healthcare to poor people. We also plan to present our findings at one or more conferences on cardiovascular prevention at the national and international level. This research will be of great interest to cardiologists and researchers who are working in preventive cardiology, as well as some healthcare decision-makers and it will create opportunities for future interdisciplinary research.

For knowledge-translation purposes, we will also publish the study findings in highly accessed, peer-reviewed scientific and health policy journals at the national and international level. This will increase the understanding of the challenges that poor people face in changing their eating behaviours, and it is possible that these contextual barriers could be included in international guidelines for CR and the secondary prevention of CVDs.