Health Related Quality of Life in Hypertensive Patients in a Tertiary Care Teaching Hospital

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1 22 Journal of the association of physicians of india vol 62 october, 2014 Original Article Health Related Quality of Life in Hypertensive Patients in a Tertiary Care Teaching Hospital Bhavit B Oza *, Bela M Patel *, Supriya D Malhotra **, Varsha J Patel *** Abstract Background: Quality of life (QOL) evaluation has emerged as an important outcome measure for chronic diseases like hypertension. Aims: To determine QOL in patients suffering from hypertension using MINICHAL and WHOQOLBREF tools. Methods and Material: The study was carried out for eight weeks in medicine outpatient department of a tertiary care hospital. All patients diagnosed with essential hypertension and on drug therapy for at least one month were included. Their sociodemographic and clinical data were noted. Patients were interviewed for QOL using two questionnaires WHOQOLBREF and MINICHAL scale. Results: Total 269 patients had mean age and duration of hypertension ± and 7.65 ± 8.00 years respectively. Age, duration of illness, number of symptoms, systolic blood pressure and number of drugs prescribed showed statistically significant (P < 0.05) negative correlation with WHOQOLBREF score while number of symptoms, systolic blood pressure and duration of illness showed statistically significant positive correlation with MINICHAL scale (P < 0.05). MINICHAL scale and WHOQOLBREF were significantly correlated with each other (P < 0.01). Women had significantly poorer QOL compared to men. Conclusions: Age, female gender, duration, number of symptoms, systolic blood pressure and number of medications may be important predictors of QOL in hypertensive patients. * 2 nd Year Resident, ** Associate Professor, *** Professor and Head, Department of Pharmacology. Smt. NHL Municipal Medical College, Ahmedabad , Gujarat Received: ; Accepted: Introduction The overall burden of hypertension related diseases is rapidly rising in the developing world. 1 Quality of Life (QOL) is a broad ranging concept affected in a complex way by the person s physical health, psychological state, level of independence, social relationships, personal beliefs and their relationship to salient features of their environment. 2 Health related QOL (HRQOL) is emerging as an important outcome in hypertension and can be adversely affected by hypertension itself and sideeffects of antihypertensive drugs. 3 However reports of HRQOL among hypertensive individuals have been conflicting, with some studies finding worse HRQOL among hypertensives compared to the general population 4, 5 while Moum T et al reported no impact of hypertension on HRQOL in some / all s. 6 There is a paucity of studies reporting QOL in Indian hypertensive patients. Hence this study was conducted to determine QOL in hypertensive patients using MINICHAL, a specific tool for assessing QOL in hypertensive individuals and WHOQOLBREF (world health organisation quality of life BREF), a generic tool applicable in any chronic disease and also to evaluate compatibility of these two QOL tools. Subjects and Methods Study population The study was a cross sectional study conducted over a period of eight weeks to evaluate HRQOL of patients being managed for essential hypertension at outpatient department of medicine of a tertiary care teaching hospital. Study began after approval

2 Journal of the association of physicians of india vol 62 october, from institutional review board. Written informed consent was obtained from each participant. All patients with age 18 years and above suffering from essential hypertension and on antihypertensive treatment for at least one month were included in the study. Patients who were newly diagnosed and those who denied consent for QOL interview were excluded from the study. Inpatients were excluded because majority of the inpatients would be acutely ill with markedly altered QOL. All hypertensive patients seen at the clinic during study period who met the inclusion criteria were invited to participate in the study. Sample size was determined by taking standard deviation 9.6, alpha 0.05, critical difference 1.90 and power of the study 90%. It was necessary to involve 254 patients in the study. 8 Patients were approached after they finished consultation with physician. Their socio demographic characteristics and clinical data were noted. The socio demographic data included age, gender, social class, marital status, number of children and education qualification. Clinical data included symptoms, duration of hypertension, BP reading, comorbidities / complications, drugs prescribed and nonpharmacological measures followed by patients. Patients were classified into four groups according to JNC (joint national committee) 7 criteria. 9 Patients falling into category of stage 1 and 2 of hypertension were classified as uncontrolled while others as controlled hypertension. Thereafter patients were interviewed about QOL by using two QOL questionnaires MINICHAL scale (hypertension specific) and WHOQOLBREF (generic). Questionnaires to measure healthrelated quality of life Both instruments were translated in vernacular (Gujarati) language and back translated to ensure content validity. Questionnaires are designed for selfadministration but most of the patients required structured interview due to low educational level. In the interviews, the patients were asked to respond based on the last seven days. To test feasibility of the instruments pilot study was carried out on 25 patients. It took approximately about 20 minutes to collect data from one patient (consent, history, QOL scales). MINICHAL scale 7 The MINICHAL was developed in Spain in 2001 and contains 17 items. This instrument can be used both for populationbased studies and clinical trials to assess a patient s QOL. MINICHAL word was derived from Mini Cuestionario de Calidad de Vida en Hipertensión Arterial. It consists of two s mental (nine items) and somatic (seven items). The mental includes questions one to nine and score ranges from 0 to 27 points. The somatic includes questions 10 to 16 and score ranges from 0 to 21 points. Last question is related to the overall impact of hypertension on the QOL. The score scale is Likert scale with four possible answers (0 = No, not at all; 1 = yes, somewhat; 2 = yes, a lot; 3 = yes, very much). Total points range from 0 (best level of health) to 51 (worst level of health). WHOQOLBREF scale 2 This is a 26 item self administered generic questionnaire. The WHOQOLBREF is one of the most commonly used generic QOL questionnaire which was developed simultaneously across a broad range of member countries, assuring that it could be used more multiculturally and multilingually than any other existing QOL tool. It emphasises subjective response rather than objective life condition, with assessment made over the preceding two weeks. 10 All items, on a fivepoint scale, could be classified into five s: overall general health global (two items), physical (seven items), psychological (six items), social relationships (three items) and environment (eight items). The response option ranges from 1 (very dissatisfied / very poor) to 5 (very satisfied / very good). The total raw score for these five dimensions is transformed into 0 (lowest) to 100 (highest) with low score indicating poor QOL. 11 Statistical analysis Microsoft Excel 2007 and SPSS version 20 were used to analyse the data. Descriptive analysis included calculation of means, standard deviations (SD) and frequencies of categorical variables. The statistical correlations between two different QOL instruments, different s of QOL, socio demographic and clinical parameters was analysed using Pearson correlation coefficient test. Student s ttest was used to compare means between two groups. The values were considered statistically significant if P < Results Sociodemographic and clinical characteristics Table 1. Out of 320 patients invited to participate in the study, 269 consented for participation (response rate 84.06%). Participants mean age was ± years and 113 (42%) were male. Majority of the patients 179 (66.5%) belonged to age group years. Majority of the patients were educated up to school level (59.9%) and belonged to others category of occupation (76.2%). Mean number of symptoms were 3.65 ± About 60% patients presented with at least three symptoms at the time of interview. Fatigue 220 (81.8%) was most common symptom. Mean duration of hypertension was 7.65 ± 8.00 years. Out of 269, 225 (83.26%) patients had associated comorbidities, ischaemic heart disease (IHD) being most common in 106 (39.4%) participants. Mean systolic and diastolic BP were 137 ± and

3 24 Journal of the association of physicians of india vol 62 october, 2014 Table 1: Socio demographic and clinical characteristics of participants (N=269) Parameter [Range] Values N (%) Age (years) [32 78] ± (Mean ± SD) (4.5%) (12.3%) (30.1%) (36.4%) (16.7%) Gender Male 113 (42%) Female 156 (58%) Religion Hindu 158 (58.7%) Muslim 109 (40.5%) Other 2 (%) Marital status Married 195 (72.5%) Single 13 (4.8%) Widowed 61 (22.7%) Number of children [ 0 10 ] 3.56 ± 1.66 (Mean ± SD) < (50.2%) (49.8%) Weight Normal / underweight 107 (39.8%) Moderately overweight 108 (40.1%) Obese 54 (20.1%) Educational status Uneducated 74 (27.5%) Up to school 161 (59.9%) Graduate 30 (11.2%) Postgraduate 4 (%) Occupational class White collar 4 (%) Self employed 20 (7.4%) Blue collar 40 (14.9%) Others (housewives, retired etc.) 205 (76.2%) Number of symptom [0 11] 3.65 ± 2.63 (Mean ± SD) No symptom 8 (3.0%) 1 symptom 60 (22.3%) 2 symptoms 39 (14.5%) 3 symptoms 162 (60.2%) ± 8.03 mm of Hg respectively. Hypertension was uncontrolled in about 44% patients. Mean number of drugs prescribed were 7.12 ± 2.31 while mean number of antihypertensive drug prescribed were 2.06 ± About 126 (46.8%) followed nonpharmacological measures apart from drug therapy. Angiotensin receptor blockers 164 (61%) was the most commonly prescribed drug group followed by β blockers 120 (44.6%). HMG Co A reductase inhibitors Statins (71.7%) was most common concomitant drug group followed by antiplatelet drugs (69.9%) (Table 1). WHOQOLBREF questionnaire For overall and general health related questions 60 70% of patients responded as average to good. As far as physical, Parameter [Range] Values N (%) Prevalence of symptoms Fatigue, Weakness Frequent insomnia Headache Dizziness Blurred vision 220 (81.8%) 169 (62.8%) 102 (37.9%) 92 (34.2%) 69 (25.7%) Duration of hypertension [ ] 7.65 ± 8.00 (Mean ± SD) (years) (9.7%) 81 (30.1%) 80 (29.7%) 82 (30.5%) Number of comorbidities [ 0 4 ] Ischaemic heart disease Type 2 diabetes mellitus Osteoarthritis Cerebro Vascular Accident 1.48 ± 0.95 (Mean ± SD) 106 (39.4%) 88 (32.7%) 30 (11.2%) 28 (10.4%) Systolic BP (mm of Hg) [ ] 137 ± (Mean ± SD) Diastolic BP [ ] ± 8.03 (Mean ± SD) Stages of hypertension Normal Prehypertension Stage 1 Stage 2 16 (5.9%) 135 (50.2%) 75 (27.9%) 43 (16.0%) Total number of drugs [ 2 13 ] ± 2.31(Mean ± SD) 40 (14.9%) 160 (59.5%) 69 (25.7%) Number of antihypertensive drugs 2.06 ± 0.97 (Mean ± SD) [1 5 ] Nonpharmacological measures [ 0 4 ] 0.61 ± 0.80 (Mean ± SD) Compliant Non compliant 126 (46.8%) 143 (53.2%) SD Standard deviation, BP Blood Pressure psychological, social and environmental s were concerned, majority of the patients responded as poor to good except a few responding as very good for physical. Table 2 depicts distribution of responses (%) for WHOQOL BREF. MINICHAL scale Regarding mental related questions majority of the participants responded as yes, somewhat and yes, a lot. Somatic related responses by majority of the patients lay between Not, at all and Yes, a lot. About 67% patients responded that QOL is affected a lot by hypertension and its treatment. Mean of Not at all response for mental and somatic was and respectively, indicating mental was affected more compared to somatic. Distribution of responses of MINICHAL scale is shown in Table 3. MINICHAL and WHOQOLBREF scales were significantly correlated with each other (P < 0.01). HRQOL scores of MINICHAL scale showed significant

4 Journal of the association of physicians of india vol 62 october, Table 2 : Distribution of responses (%) in WHOQOL BREF items (N = 269) Items Very poor 1 Poor 2 Average 3 Good 4 Very good 5 OG: Overall general health Q1 General QOL Q2 General health D1: Physical Q3 Pain and discomfort Q4 Dependence medication Q10 Energy and fatigue Q15 Mobility Q16 Sleep and rest Q17 Activities of daily living Q18 Working capacity D2: Psychological Q5 Positive feelings Q6 Spirituality, religion and personal beliefs Q7 Thinking, learning, memory, concentration Q11 Body image Q19 Self esteem Q26 Negative feelings D3: Social relationships Q20 Personal relations Q21 Sex Q22 Practical social support D4: Environment Q8 Safety Q9 Home environment Q12 Financial resources Q13 Information Q14 Recreation and leisure Q23 Physical environment Q24 Access to health care Q25 Transport WHOQOLBREF World Health Organization Quality Of Life BREF, QOL Quality of Life, SD Standard Deviation Mean ± SD 2.88 ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± 0.61 negative correlation with WHOQOLBREF scores. WHOQOLBREF s were significantly and positively correlated with one another. Pearson correlation between WHOQOLBREF and MINICHAL scale is shown in Table 4. Age showed significant negative correlation with all WHOQOLBREF s (P < 0.05) except environmental. Systolic BP and number of symptoms showed significant positive correlation with MINICHAL scale (P < 0.05) and negative correlation with WHOQOLBREF s (P < 0.05). Number of comorbidities showed significant positive correlation with MINICHAL s (P < 0.05) and negative correlation with WHOQOLBREF s (P < 0.05) except global. Number of drugs prescribed showed significant negative correlation with physical and social s of WHOQOLBREF scale (P < 0.05) while positive correlation with MINICHAL s which was not statistically significant. Pearson correlation between different variables and HRQOL scales is depicted in Table 5. Mean scores of MINICHAL and WHOQOLBREF were ± 7.81 (range 2 43) and ± 9.14 (range 48 96) respectively. Social score was lowest while physical score was highest for WHOQOLBREF. Men showed significantly lower scores for MINICHAL scale and higher scores for WHOQOLBREF scale (P < 0.05) compared to women. Comparison of HRQOL scores between men and women is depicted in Table 6. Among WHOQOL BREF s physical, psychological, social and total WHOQOLBREF scores were lower in patients with comorbidities compared to patients without comorbidity (P < 0.05). Patients with uncontrolled hypertension had lower scores of WHOQOLBREF except psychological and higher scores of MINICHAL scale compared to those with controlled hypertension. However the difference was not statistically significant. (P > 0.10)

5 26 Journal of the association of physicians of india vol 62 october, 2014 Table 3 : Distribution of responses (%) in MINICHAL scale items (N = 269) Items No, not at all Yes, somewhat Yes, a lot Yes, very much Mean ± SD Mental Q1 Poor sleep ± 1.00 Q2 Difficulty to maintain social relations ± 0.65 Q3 Difficulty in interaction ± 0 Q4 Not playing useful role ± 0.64 Q5 Unable to make decision ± 0.68 Q6 Felt distressed continuously ± 0.98 Q7 Life is a struggle ± 0.67 Q8 Not enjoying daily activities ± 1 Q9 Felt worn out ± 0.69 Somatic Q10 Felt sick ± 0.64 Q11 Felt breathless ± 0.87 Q12 Swollen ankles ± 0.96 Q13 Frequent urination ± 0.99 Q14 Dry mouth ± 0.95 Q15 Chest pain without exertion ± 0.89 Q16 Tingling and numbness ± 0.90 Q17 Quality of life affected by hypertension and its treatment ± 0.57 SD Standard Deviation Table 4 : Pearson Correlation between WHOQOLBREF and MINICHAL scale Mental Somatic Total MINICHAL score Overall and general health Physical Social Psychological Environmental Total WHOBREF Score Mental 1 Somatic 0.581** 1 Total MINICHAL 0.904** 0.871** 1 score Overall general 0.622** 0.483** 0.630** 1 health Physical 0.486** 0.288** 0.444** 0.444** 1 Psychological 0.474** 0.281** 0.434** 0.613** 0.477** 1 Social 0.547** 0.424** 0.553** 0.545** 0.562** 0.609** 1 Environmental 0.596** 0.458** 0.603** 0.598** 0.414** 0.693** 0.614** 1 Total WHOBREF score 0.673** 0.474** 0.656** 59** 22** 0.849** 0.800** 0.866** 1 **Correlation is significant at the level 0.01 (based on 2 tailed Pearson correlation coefficient) WHOQOLBREF World Health Organization Quality of Life BREF Discussion For chronic disease like hypertension assessing quality of life can help in evaluating the physical and psychosocial impact of the disease on affected individuals. It can also serve as important outcome measure for different therapeutic interventions whether pharmacological or nonpharmacological. According to a recent study, patients with hypertension have worse QOL particularly when BP is controlled by drugs! 12 As there are no studies reported from India, this study becomes important in this regard. We used MINICHAL as hypertension specific tool as it is recommended that a measuring instrument validated in a foreign language if adapted in other country would allow a common measure to investigate QOL within different contexts and help in making comparisons across the countries besides saving time and financial resources. 13 Both WHOQOLBREF and MINICHAL scale were inversely and significantly correlated with each other. Higher MINICHAL score implies impaired QOL while higher WHOQOLBREF score implies better QOL. Significant correlation between two scales is also reported by Melchiors AC et al with WHOQOLBREF physical best correlated with total MINICHAL score. 14 In our study MINICHAL mental was the one that best correlated with total WHOQOL BREF score. Our study shows that MINICHAL can be a useful instrument for assessing QOL in Indian

6 Journal of the association of physicians of india vol 62 october, Table 5 : Pearson Correlation between different variables and HRQOL scales Mental Somatic Total MINICHAL Score Global Physical Psychological Social Environmental Total WHOBREF Score Age **.132*.240** ** Systolic BP.138*.123*.152*.183**.251**.126*.164**.145*.214** Diastolic BP *.129* * Number of.454**.510**.544**.346**.316**.199**.294**.295**.355** symptoms Duration of **.172** * hypertension Number of comorbidities.133*.159**.166** **.184**.186**.137*.199** Number of drugs * ** *correlation is significant at level of 0.05, **correlation is significant at level of 0.01 (based on 2 tailed Pearson correlation coefficient) HRQOL Health related quality of life, WHOQOLBREF World Health Organization Quality Of Life BREF, BP Blood Pressure Table 6 : Comparison of HRQOL scores between men and women participants (N = 269) Domains All (N = 269) Score (Mean ± SD) Men (N = 113) Women (N = 156) P value MINICHAL scale Mental ± ± ± *** Somatic 8.96 ± ± ± ** Total ± ± ± 7.82 <.001*** WHOQOLBREF Overall and ± ± ± <.001*** General health Physical ± ± ± ** Psychological ± ± ± * Social ± ± ± ** Environmental ± ± ± * Total ± ± ± ** * significant at < 0.05, ** significant at < 0.01, *** significant at < (based on Student s ttest). HRQOL Health related quality of life, WHOQOLBREF World Health Organisation Quality of Life BREF, SD Standard Deviation hypertensive patients, whose results significantly correlated with the generic instrument WHOQOL BREF. Socio demographic and clinical characteristics like age, duration of hypertension, systolic and diastolic BP are consistent with previous studies. 3,15 Mean age of participants and most common comorbidities were comparable with recent study from India. 16 In this study 97% of the patients were symptomatic probably due to associated comorbidities in majority (83%) of patients with IHD being most common followed by DM. Our study population differs from previous studies that our population had higher symptom and co morbidities count, both can affect QOL adversely. 8,15 Our study shows that hypertension associated with comorbidities adversely affects HRQOL which was in accordance with previous studies. 17,18 Of our participants 44% had uncontrolled BP which is lower than stated by WHO that three fourths of the patients are not able to achieve optimal blood pressure control even after drug therapy. 19 Mean score for MINICHAL was ± 7.81 (range 2 43) which was higher compared to previous similar study from Brazil suggesting poorer QOL of our study population. 20 The MINICHAL exhibits wider score range compared to WHOQOLBREF which suggests specificity of MINICHAL for hypertensive patients. Mean score for WHOQOLBREF was ± 9.14 (range 48 96) and individual scores were lower compared to previous study from Brazil which again suggests poorer QOL in our study population. 14 This may be due to our study population had higher symptom score and comorbidities. Poor nutritional status of our population reporting to general hospital may also contribute to some extent. For WHOQOLBREF, among various s social scored lowest while physical scored highest. As our study population comprises of patients of poor socioeconomic status, minor symptoms, mild disturbance of any kind are often not noticed. Poor educational status, lack of awareness regarding health and socio cultural factors may have contributed to higher physical score in hypertensive patients. Important contributing factor for lowest social QOL could be poor sexual life of patients. Quite a few respondents hesitated in answering the question related to sex hence it is not possible to be certain about the reliability of social score. This finding demonstrates the cultural differences affecting QOL assessment. Age, systolic BP, number of symptoms and number of comorbidities showed significant negative correlation with some of the WHOQOLBREF s and positive correlation with MINICHAL scale which suggests as these parameters increase, QOL worsens. Number of drugs prescribed showed significant negative correlation with physical and social s of WHOQOLBREF scale suggesting worsening of QOL by polypharmacy. MINICHAL scale is disease specific so the number of symptoms showed stronger correlation compared to WHOQOLBREF s. Generic instrument is more effective in obtaining

7 28 Journal of the association of physicians of india vol 62 october, 2014 information about correlation of various clinical variables (age, BP, duration of hypertension, number of comorbidities and number of drugs prescribed) except number of symptoms where disease specific instrument is more effective. Generic instrument (WHOQOLBREF) is more informative because it contains five s and 26 questions hence it includes each and every aspects of patients health status. Probably MINICHAL may be better used to complement a generic tool rather than as a sole instrument for assessing QOL in hypertension. The adverse influence of increasing BP on HRQOL has been well documented but very few studies have emphasised the influence of symptoms on HRQOL of hypertensive patients Though hypertension is seen as an asymptomatic condition, increasing symptom count and BP is a major determinant of the HRQOL of hypertensives. 26 In our study, symptom count and systolic BP were predictors of QOL. Male patients showed significantly lower scores of MINICHAL scale and higher scores of WHOQOL BREF scale suggesting poorer QOL in females compared to males which is in accordance with previous studies. 8,14,15,27,28 Indian society is male dominant especially in lower socioeconomic class hence greater importance is given to men even in illness who are more likely to take medications than women. Thus, poor treatment compliance is expected more in women compared to men affecting QOL adversely in women. To our knowledge this is the first study evaluating quality of life in Indian hypertensive patients. Both instruments are significantly correlated with each other. We examined the relationship of QOL to various socio demographic and clinical variables. As the study population is from a single centre the findings cannot be generalised. Further multicentric studies with larger sample size are required in this direction. Conclusion MINICHAL significantly correlated with WHOQOL BREF in all s, proving to be a useful tool for the assessment of quality of life in Indian hypertensive patients. Age, female gender, duration, number of symptoms, systolic BP and number of comorbidities are important predictors of QOL in hypertensive patients. These HRQOL tools may be helpful to choose the best treatment and to assess the impact of therapeutic interventions on quality of life of hypertensive patients. Acknowledgement We are thankful to Dr. Hemant Tiwari for his guidance in data analysis. We are also thankful to all the patients who have participated in the study. References 1. Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. et al. Global burden of hypertension: analysis of worldwide data. Lancet 2005;365:21723.[PMID: ] 2. WHOQOL: Development of the World Health Organization WHOQOLBREF quality of life assessment. The WHOQOL Group. Psychol Med 1998;28: WF Khaw, STS Hassan and AL Latiffah. 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