Health-related quality of life in patients with chronic obstructive pulmonary disease in North IndiaH Negi1, M Sarkar2, AD Raval3, K Pandey4, P Das1
1 Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research, Hajipur, India
2 Department of Pulmonary Medicine, Indira Gandhi Medical College and Hospital, Shimla, India
3 Department of Pharmaceutical Systems and Policy, West Virginia University, Morgantown, West Virginia, USA
4 Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences, Indian Council of Medical Research, Patna, India
Correspondence Address: Source of Support: None, Conflict of Interest: None DOI: 10.4103/0022-3859.128797
Source of Support: None, Conflict of Interest: None
Background and Objectives: Chronic obstructive pulmonary disease (COPD) is a major health problem in India and constitutes an important cause of mortality and morbidity. A cross-sectional study was undertaken to assess health-related quality of life (HRQL) and its determinants in patients with COPD from India. Materials and Methods: A total of 126 patients (73.81% male) were enrolled using convenient sampling prospectively in this cross-sectional study. Eligible patients were assessed for socioeconomic status, anthropometric measures, COPD severity, dyspnea and health status using the Hindi version of St George's Respiratory Questionnaire (SGRQ). Linear regression model was used to examine the association between risk factors and HRQL score (a higher score indicating poorer HRQL), adjusting for age and sex. Results: The mean total score for SGRQ in the patients was 52.66 ± 12.89, indicating a marked impairment of HRQL. Impairment was associated with the severity of airway obstruction, but within each Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage, the variation (SD) was wide [stage I: 47.8 ± 12.3 (n = 14); stage II: 49.28 ± 11.69 (n = 47); stage III: 53.47 ± 11.69 (n = 44); stage IV: 61.75 ± 14.14 (n = 21)]. A regression analysis showed that body mass index, forced expiratory volume in 1 s (FEV 1 ), dyspnea grade, and depression were associated with poor HRQL. Conclusion: HRQL of COPD patients was significantly impaired across stages. Marked impairment of HRQL was found even in patients with mild disease.
Keywords: Chronic obstructive pulmonary disease, Global Initiative for Chronic Obstructive Lung Disease, health-related quality of life, India, tertiary care
Chronic obstructive pulmonary disease (COPD) is a prevalent disease affecting 6-8% of the population in India.  The Global Initiative for Chronic Obstructive Lung Disease (GOLD) defines COPD as "a preventable and treatable disease with some significant extrapulmonary effects that may contribute to the severity in individual patients."  Mortality and morbidity associated with COPD is currently greater in Asia than that in developed countries.  COPD is also associated with a significant reduction in quantity as well as quality of life. 
COPD and its associated symptoms, such as fatigue and dyspnea, cause restriction on patients' exercise tolerance, and consequently have a major impact on their ability to carry out daily activities, thus resulting in a reduced quality of life (QOL). COPD is largely irreversible and responsible for subsequent deterioration in health status due to airflow obstruction.  Health-related quality of life (HRQL) refers to the physical, psychological, and social domains of health that are unique to each individual.  HRQL has attracted considerable attention over the past decade as impaired health status is an important determinant of mortality,  exacerbation and hospital admission, and response to diverse treatment options. 
Although many studies have reported impaired HRQL in patients with COPD and poor HRQL has been shown to be associated with different physiological factors, to our knowledge, in Indian context, there is only one study from South India that found that patients with COPD had reduced quality life that was associated with duration of disease, severity of disease, as well as dyspnea.  Thus, the present study was undertaken to assess the status and predictors of HRQL in COPD patients visiting a tertiary care setting of the North Indian region.
This cross-sectional study was carried out in Indira Gandhi Medical College (IGMC) from November 2011 to April 2012. COPD patients visiting the chest clinic were recruited in using convenience sampling. Study population fulfilled the GOLD criterion of forced expiratory volume in 1 s (FEV 1 ) to forced vital capacity (FVC) less than 0.70 (FEV 1 /FVC ratio <70%). Diagnosis of COPD was established by a respiratory physician based on medical history, current symptoms, suggestive findings from physical examination and available pulmonary function tests, using the definitions provided by American Thoracic Society and European Respiratory Society. We included only those patients who were clinically stable with no exacerbations and without change in medication during the last 4 weeks from the date of inclusion in the study. Patients with comorbid conditions like asthma, cardiovascular disease, arthritis, diabetes, and incontinence/prostate disease that can affect HRQL of patients were excluded. The study protocol was approved by the institutional review board and written informed consent was obtained from each patient pre inclusion.
Assessment of HRQL
A validated Hindi version of St George's Respiratory Questionnaire (SGRQ) was administered for self-assessment when the patients were clinically stable.  The SGRQ is composed of 50 items with 76 weighted responses that cover three components - symptoms, activity, and impact - which relate to frequency and severity, restriction in physical activities and social function, and psychological disturbances resulting from respiratory disease, respectively. For each subscale and for the overall questionnaire, scores ranged from zero (no impairment) to 100 (maximum impairment).
Information was collected on the following variables using a structured questionnaire: Demographic characteristics, socioeconomic status, and anthropometric measurements, smoking habits, and exposure to biomass fuel. Smoking status was calculated in terms of smoking index which is the product of average number of cigarettes smoked per day and the total duration of smoking in years.  Pulmonary function tests (post bronchodilator FEV 1 , FVC, and FEV 1 /FVC) were measured using a computerized spirometer (Model Vitalograph Pneumotrac 6800; SN.PN-06011 Ireland) and carried out by trained personnel with several years of experience.
Patients' perceived breathlessness was scored on the basis of their response to Medical Research Council (MRC) Dyspnea scale.  Depression was evaluated with the validated Hindi version  of the nine-item PHQ-9 (a subset of Patient Health Questionnaire). PHQ-9 consists of the actual nine criteria on which the diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) depressive disorders is based. The total score can range from 0 to 27, and depending upon the total score, the severity of depression was classified.
Continous data were expressed as numbers, percentages, and means ± SD, or medians and 25 th or 75 th percentiles. Characteristics of the participants and the SGRQ score were compared across the stages of COPD severity using the unpaired t-test or Wilcoxon rank sum test (for quantitative variables) and chi-squared or Fisher's exact test (for categorical variables). Analysis of the association between HRQL domains and individual determinants in patients with COPD was carried out using linear regression analysis, controlling for age and sex. All the analysis were conducted using IBM SPSS version 19.
Demographic and clinical characteristics of the study patients are represented by GOLD stages in [Table 1]. The sample had a higher proportion of patients with stage II (37%) and stage III COPD (35%) compared to stage I (11%) and stage IV (17%) COPD. A total of 51 (40.5%) patients had severe dyspnea on MRC dyspnea scale, and 66 patients showed depressive symptoms with 26 having major depressive disorder. HRQL scores showed significant impairment across all levels of airway obstruction, even in patients with mild disease [Table 2]. The mean score for all domains of HRQL was 52.7 (GIVE SD), which was significantly different with respect to GOLD stages. The mean HRQL scores for symptom, activity, and impact domains were 58.8 (SD 17.2), 61.3 (SD 13.2), and 45.6 (SD 14.1), respectively, which suggested marked impairments in HRQL in all the quality of life domains. Across all the findings, the score of all HRQL domains was significantly higher with severe stages of COPD.
In an adjusted linear regression model, lower FEV 1 , higher dyspnea scores, lower level of education, lower body mass index (BMI), and depressive symptoms were associated with higher SGRQ total score (or worse HRQL) [Table 3]. In addition to these factors, a higher smoking index was associated with a higher SGRQ activity score, while a lower level of education was independently associated with a higher SGRQ activity and impact score. Educational status showed significant negative linear relationship with all domains (activity = 0.013, impact = 0.004, total = 0.008) except for symptoms.
Our study found that patients with COPD had an impaired quality of life overall. HRQL was markedly impaired across all levels of severity of airway obstruction. Health status in patients with COPD is influenced by many different factors. This study shows that the most significant factors that determine the health status in COPD patients are the level of education, BMI, FEV 1 , dyspnea, and depression. Smoking was also shown to be associated with activity domain, whereas no association was found with other demographic variables. As the study patients had been smoking for a long time with high smoking index, effective intervention strategies to quit smoking in COPD patients are mandatory.
Education status was also associated with poor HRQL, which could be due to lack of knowledge about disease resulting in non-compliance with medication and medical intervention. BMI was a significant predictor of HRQL, which is in accordance with previous studies that have shown underweight patients having worse health status than patients of normal weight.  Further, disease severity (based on FEV 1 ) significantly influenced HRQL among COPD patients. Previous studies have also shown significant association of health status with disease severity as the disease passed to more severe stages. ,
Impact of airway obstruction on HRQL is demonstrated by the significant relationship between FEV 1 and SGRQ. Additionally, the importance of dyspnea causing patients with COPD to reduce their activities of daily living  had also resonance in present study, with dyspnea showing a significant positive relationship with HRQL. There is a bi-directional association between depression and HRQL. Disease symptoms and impaired functional status may develop the ability to cope up with compromised living, which in turn results in development of depression. On the other hand, the presence of depression may ultimately affect the functional status of individuals with COPD, which would reduce the overall quality of life. Hence, there should be interventions to screen depression and for treating it among patients with COPD to improve their quality of life.
This study provides preliminary data on impaired HRQL in patients with COPD at the northern region of India. It also found that disease-related factors as well as depression, dyspnea, and anxiety were significantly associated with poor HRQL.
Limitations of our study include (1) its relatively small sample size and (2) inability to assess some of the objective parameters like 6-minute walk distance, which would have been a better measure their health status. As this was a cross-sectional study, it was not possible to determine the causal association between risk factors and HRQL. A long term, longitudinal study should be conducted in future to assess the impact of severity of COPD on the impairment of HRQL.
[Table 1], [Table 2], [Table 3]