Our study aimed to assess health-related quality of life and the factors influencing it in postmodified radical mastectomy patients using the WHO QOL BREF and the SF-36 questionnaires. We also aimed to compare the application feasibility of these two tools in the OPD setting and terms of the duration of application.
This study was proposed for the short-term studentship (STS) programme, an initiative from the Indian Council of Medical Research (ICMR), Government of India. After the ICMRs approved the proposal, approval was obtained from the Institute Ethics Committee of All India Institute of Medical Sciences, Nagpur (reference number: IEC/Pharmac/2022/423). This cross-sectional survey-based study was conducted over two months (August 2022-September 2022) in the Department of Surgery in All India Institute of Medical Sciences Nagpur, India. This study had a limited duration. Based on the average number of breast carcinoma patients presenting in the OPD weekly, 30 patients were included.
Patients who underwent modified radical mastectomy (MRM) for breast carcinoma within the past six months after the commencement of the study were contacted through telephone conversations. Patients who underwent MRM within the first month of the study were also included. Patients with a preexisting psychiatric disorder, severe comorbidities or recurrent disease were excluded. Male patients with breast carcinoma were also excluded from the study. Informed written consent was obtained from every patient willing to participate in the study. Detailed sociodemographic information was recorded in the appropriate study proforma. We used the WHO QOL BREF and SF-36 to measure QoL in the study cohort.
The SF 36 comprises an evolution of the earlier Health Insurance Experiment survey and Medical Outcome Study survey developed by the Research and Development (RAND) Corporation (Ware and Shelbourne, 1992) (5). It measures eight health concepts. These concepts include physical functioning, role limitations due to physical health, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and emotional well-being. All eight domains define distinct physical and mental health functions. Three of the eight domains, physical functioning, role limitation due to physical health, and bodily pain, correlate most strongly with physical components. The other three domains, emotional well-being, emotional role, and social functioning, correspond to mental elements. Vitality, social functioning, and general health are associated with physical and mental health (5, 6).
The WHO QOL BREF, developed in 1997, is an abbreviated version of the WHO QOL-100. This QoL assessment tool has four domains: social health, physical health, psychological health, and environmental health. There are twenty-six items in the four domains, and all the items can be self-administered (7). Each item is marked on a scale ranging from 1 to 5. The scores of individual domains of the WHO QOL-BREF are strongly correlated with similar scores on the WHO QOL-100 (7).
The validated and translated versions of both questionnaires in Hindi and Marathi are available on the official websites of the WHO and RAND. The questionnaires were provided in the language that the patient preferred most. The individuals in the study group were asked to complete both questionnaires in a single session in the follow-up outpatient department (OPD). Patients who underwent MRM within one month of the study were given the questionnaires at the first follow-up. The participants in the study group were again asked to complete the same questionnaires after two weeks. The questionnaires were self-administered if the respondents could read and understand the items; otherwise, interviewer-assisted methods were used. The respondent set and other biases were avoided by clearly explaining the question and providing information based on their experience in the past four weeks. For the emotional and mental domain, the respondent was instructed that the response that came to mind first was the actual situation. Each item in all the domains of the questionnaires was scored according to the patient's response. The duration of each administration was noted, and the average time for the two questionnaires was taken separately. Patient privacy was maintained during the data collection. The documents and information were kept confidential by appropriate means.
According to the scoring system's instruction manual guidelines, the scores were transformed into predetermined scales. The mean scale value of the items within each domain was used to calculate the domain score. The study population was divided into different strata based on age group, clinical disease stage, socioeconomic status, education level, marital status, time since MRM, history of oral contraceptive pill use, and QoL. The modified Kuppuswamy scale was used to determine socioeconomic status. Descriptive statistics are presented as the mean ± standard deviation (SD) or median (range) for continuous data or as a percentage for counts. We performed a preliminary analysis to verify the assumptions of normality and linearity of the variants. Normally distributed data were compared using parametric tests. We examined the association between the characteristics of the surveyed population and the domains of health-related QoL measured by the WHO QOL BREF and SF-36. Simple linear regression models were used. The correlation coefficients of different characteristics of the study population were calculated. Significance was set at the 5% level, and a p-value less than 0.05 was considered to indicate statistical significance.