Health-related quality of life in postcardiac interventional catheterization patients with congenital heart disease: a mixed-methods study protocol from Pakistan

IntroductionImprovement in health-related quality of life (HRQoL) has been reported in patients with congenital heart disease treated with interventional cardiac catheterization; however, there is a significant dearth of literature from low/middle-income countries (LMICs) about this aspect. Multiple factors like sociodemographic and cultural differences, variable procedural outcomes due to lack of technical expertise and limited resources and inconsistent postprocedure follow-up may affect HRQoL in LMICs. This protocol paper aims to describe the study methodology to determine the HRQoL and its predictors in patients who have undergone interventional cardiac catheterization. Conclusions from this protocol study will help prepare a holistic approach to delivering care to patients in low-resource settings.Methods and analysisA mixed-methods study design will be used. The quantitative arm will compare the HRQoL of these postcardiac interventional catheterization patients with their age-matched healthy siblings to identify the HRQoL predictors, whereas the qualitative arm will further explore the experiences of these patients and parents. A minimum number of 108 patients of age 2 years and above, at least 6 months postinterventional catheterization follow-up and ability to understand Urdu/English will be enrolled. PedsQL 4.0 Generic Core Scales, PedsQL Cognitive Functioning Scale and PedsQL 3.0 Cardiac Module will be used. The Student’s t-test will analyse the difference in the means of HRQoL between patients and siblings. Multiple regression will identify HRQoL predictors. A subsample of enrolled patients and parents will be interviewed and analysed using directed content analysis (a qualitative component of the study).Ethics and disseminationEthics approval has been obtained from Ethics Review Committee of The Aga Khan University, Pakistan (ERC #2020-3456-11808). Study findings will be published in peer-reviewed journals and presented at conferences.

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Health-related quality of life in congenital heart disease surgery patients in Pakistan: protocol for a mixed-methods study

BMJ Open ◽

10.1136/bmjopen-2017-018046 ◽

2017 ◽

Vol 7 (10) ◽

pp. e018046 ◽

Cited By ~ 4

Author(s):

Laila Akbar Ladak ◽

Babar Sultan Hasan ◽

Janice Gullick ◽

Khadija Awais ◽

Ahmed Abdullah ◽

...

Keyword(s):

Quality Of Life ◽

Congenital Heart Disease ◽

Congenital Heart ◽

Mixed Methods Study ◽

Health Related Quality ◽

Healthy Siblings ◽

Related Quality ◽

Health Related

IntroductionReduced health-related quality of life (HRQOL) has been reported in postoperative patients with congenital heart disease (CHD). However, there is a paucity of data from low-income and middle-income countries (LMIC). Differences in sociodemographics and sociocultural contexts may influence HRQOL. This protocol paper describes a study exploring HRQOL in surgical patients with CHD from a tertiary hospital in Pakistan. The study findings will assist development of strategies to improve HRQOL in a resource-constrained context.Methods and analysisThis prospective, concurrent triangulation, mixed-methods study aims to compare HRQOL of postsurgery patients with CHD with age-matched healthy siblings and to identify HRQOL predictors. A qualitative component aims to further understand HRQOL data by exploring the experiences related to CHD surgery for patients and parents. Participants include patients with CHD (a minimum of n~95) with at least 1-year postsurgery follow-up and no chromosomal abnormality, their parents and age-matched, healthy siblings. PedsQL 4.0 Generic Core Scales, PedsQL Cognitive Functioning Scale and PedsQL 3.0 Cardiac Module will measure HRQOL. Clinical/surgical data will be retrieved from patients’ medical files. Student’s t-test will be used to compare the difference in the means of HRQOL between CHD and siblings. Multiple regression will identify HRQOL predictors. A subsample of enrolled patients (n~20) and parents (n~20) from the quantitative arm will be engaged in semistructured qualitative interviews, which will be analysed using directed content analysis. Anticipated challenges include patient recruitment due to irregular follow-up compliance. Translation of data collection tools to the Urdu language and back-translation of interviews increases the study complexity.Ethics and disseminationEthics approval has been obtained from The Aga Khan University, Pakistan (3737-Ped-ERC-15). Study findings will be published in peer-reviewed journals and presented at national and international conferences.

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