Health-Related Quality of Life at 30 Days Among Indian Patients With Acute Myocardial Infarction: Results From the ACS QUIK Trial
Circulation: Cardiovascular Quality and Outcomes
Abstract
Background:
Despite a high cardiovascular disease burden, data on patient-reported health status outcomes among individuals with cardiovascular disease in India are limited.
Methods and Results:
Between November 2014 and November 2016, we collected health-related quality of life data among 1261 participants in the ACS QUIK trial (Acute Coronary Syndrome Quality Improvement in Kerala). We used a translated, validated version of the Seattle Angina Questionnaire administered 30 days after discharge for acute myocardial infarction, wherein higher scores represent better health status. We compared results across sex, myocardial infarction type, and randomization status using regression models that account for clustering and temporal trends. Mean (SD) age was 60.8 (13.7) years, 62% were men, and 63% presented with ST-segment–elevation myocardial infarction. More than 2 out of 5 respondents (44%) experienced angina 30 days after hospitalization, but most (68% of respondents with angina; 27% of the total sample) experienced it less than once per week (Seattle Angina Questionnaire angina frequency score 60). Respondents rated high median (interquartile range [IQR]) scores for angina frequency (100.0 [80.0–100.0]) overall with similar unadjusted scores by sex, but between-hospitality variability was high. Median (IQR) physical limitation scale response was 58.3 (41.7–77.8), which is consistent with limitations in moderate- and high-intensity activities at 30-day follow-up. Older respondents had more angina frequency and physical limitations and lower treatment satisfaction and quality of life. Women had greater physical limitations (median [IQR], 52.8 [38.9–72.2] for women versus median [IQR], 61.1 [44.4–80.6] for men; P<0.01). Overall treatment satisfaction was high with median (IQR) score, 81.3 (75.0–93.8), but overall quality of life was lower with median (IQR) score, 66.7 (50.0–83.3). Allocation to the quality improvement intervention group had the strongest direct association with higher quality of life (difference, 4.2; P=0.03), but overall effects were modest.
Conclusions:
This study represents the largest report of quality of life among myocardial infarction survivors in India with variability across age, sex, and quality improvement intervention status. Wide variability demonstrated across hospitals warrants further study.
Clinical Trial Registration:
URL: https://www.clinicaltrials.gov. Unique identifier: NCT02256657.
WHAT IS KNOWN
•
In 2015, 7.3 million individuals died from acute myocardial infarction in India.
•
Little is known about symptoms, function, and quality of life of acute myocardial
•
infarction survivors in India.
WHAT THIS STUDY ADDS
•
This study collected data on health-related quality of life among 1261 Indian patients who have survived acute myocardial infarction at 30 days within the ACS QUIK trial (Acute Coronary Syndrome Quality Improvement in Kerala).
•
More than 2 out of every 5 patients (44%) experienced angina at 30 days with wide between-hospital heterogeneity.
•
The ACS QUIK quality improvement intervention improved health-related quality of life, although this comparison was not made across randomized groups.
Introduction
India has among the world’s highest burden of heart disease. In 2015 alone, an estimated 7.3 million individuals died from acute myocardial infarction.1 Potentially contributing to this high mortality is the marked heterogeneity in presentation and management of patients with acute coronary syndrome, as documented in the Kerala Acute Coronary Syndrome (ACS) Registry.2,3 Overall, patients in Kerala are younger, more likely to present with ST-segment elevation myocardial infarction, and less likely to receive reperfusion compared with patients in the United States.4
Inpatient and short-term mortality are important outcomes in ACS, but it is also important to understand the health status (symptoms, function, and quality of life) of survivors after hospital discharge because these outcomes can be improved with medical therapy and revascularization. Patients often care as much or more about the quality of life than their survival. Data on patient-reported health status outcomes among acute myocardial infarction survivors in India are limited and are important to understand, given the growing prevalence of heart disease in India.
The objective of this study was to evaluate health-related quality of life among Indian patients who have survived acute myocardial infarction at 30 days as a descriptive study within the ACS QUIK trial (Acute Coronary Syndrome Quality Improvement in Kerala). We were also interested in evaluating differences across age, sex, type of myocardial infarction, hospital type, and randomization status and to evaluate potential covariates associated with health-related quality of life to identify groups or targets for future intervention.
Methods
Anonymized data and materials are now available on BioLINCC.
ACS QUIK Trial
The methods and primary outcome of the ACS QUIK cluster randomized, stepped wedge trial have been published.5,6 In brief, the study’s primary aim was to evaluate the effect of an evidence-based, locally adapted quality improvement toolkit on the primary outcome of 30-day major adverse cardiovascular events, defined as all-cause mortality, reinfarction, stroke, and major Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries bleeding. The quality improvement toolkit included (1) an audit and feedback reporting mechanism, (2) training on the interpretation of these reports for informing quality improvement team meetings, (3) standardized admission and discharge order sets, (4) translated and culturally adapted patient education materials related to tobacco cessation, dietary advice, and physical activity, and (5) linkage to emergency cardiovascular care training. The study recruited 21 374 eligible participants (76% men) with acute myocardial infarction based on the Third Universal Definition of Acute Myocardial Infarction7 across 63 hospitals (67% private, 14% government, 19% nonprofit) in Kerala, India between November 2014 and November 2016. The follow-up rate was 99% at 30 days. In ACS QUIK, the primary outcome rate of major adverse cardiovascular events at 30 days was 5.3% in the intervention group and 6.4% in the control group (unadjusted odds ratio, 0.82; 95% CI, 0.73–0.91). However, after adjusting for clustering effects and temporal trends, this effect was no longer demonstrated (odds ratio, 0.98; 95% CI, 0.80–1.21).
Sampling Frame and Data Collection
Among a subsample of 1261 eligible participants, we also evaluated health-related quality of life at 30-day follow-up as a secondary objective of the trial using a translated, validated version of the Seattle Angina Questionnaire in Malayalam, the local language in Kerala (courtesy of CV Outcomes, Inc).8 The Seattle Angina Questionnaire is a 19-item instrument that evaluates patient-reported health status across 5 domains: physical limitations, angina stability, angina frequency, treatment satisfaction, and how the respondent perceives their coronary disease to impact their quality of life. Scores range from 0 to 100 for each domain, with higher scores representing better health status. A mean difference of ≥5 points is considered clinically significant.
To oversample underrepresented groups, including younger women, we used a stratified random sampling frame based on age tertiles (<50, 50–69, and ≥70 years) and sex. We sought to evaluate the prevalence and distribution of health-related quality of life among acute myocardial infarction survivors across age- and sex-groups in the ACS QUIK trial. We stratified age by <50, 51 to 70, and >70 years. A sample of 2400 participants provided 80% power with a 2-sided α of 0.05 to detect differences between age- and sex-groups based on an anticipated Seattle Angina Questionnaire score at 30 days of 60 for 369 participants in each stratum, assuming ≈10% missingness. During the recruitment period, we had slow recruitment in this substudy in the underrepresented groups and, after consultation with the trial’s Data and Safety Monitoring Board, expanded recruitment to include individuals in both the intervention and control groups in November 2015.
The Seattle Angina Questionnaire is designed as a self-administered survey, but our formative research suggested that participants would not be likely to complete this survey without support from each site’s research staff. Therefore, sites used research staff to administer the survey by in-person or telephonic interview. We excluded individuals who had missing SAQ data.
Statistical Analysis
We report unadjusted demographic, laboratory, and clinical outcome data using summary statistics, including mean and SD for normally distributed continuous variables and median with interquartile ranges (IQRs) for skewed, continuous variables overall and by sex and type of myocardial infarction (ST-segment–elevation myocardial infarction versus non–ST-segment–elevation myocardial infarction), which we compared using Student t test or Wilcoxon rank sum as appropriate. We also compared unadjusted frequencies for categorical variables overall and by strata using χ2 tests. We compared results from SAQ across sex, type of myocardial infarction, and randomization status using mixed effect linear, logistic, or quantile regression models that account for within-hospital clustering and temporal trends. We also report data by participating hospital. We adjusted for variables from the Global Registry of Acute Coronary Events risk score,9 including age, sex, type of myocardial infarction, systolic blood pressure, heart rate, acute heart failure, cardiogenic shock, and resuscitated cardiac arrest to evaluate the relationship between exposures of interest (age, sex, type of myocardial infarction, and randomization status) and individual responses to the Seattle Angina Questionnaire. We excluded serum creatinine in the models because of the high degree of missingness of this covariate.
We used Stata version 14 (StataCorp LP; College Station, TX), SAS version 9.4 (SAS; Cary, NC), and R version 3.3.0 (Vienna, Austria: R Foundation) for our statistical analyses.
Ethical Considerations
The study received ethics board approval from local, national, and international bodies and was approved by the Indian Health Ministry Screening Committee. All participants or their proxies provided written informed consent to participate.
Results
For this substudy, the participant flow is reported in Figure I in the Data Supplement. We recruited 1356 participants from the main trial (overall ACS QUIK trial n=21 374 participants) and arrived at a final sample of 1261 participants for this substudy after excluding incomplete and duplicate surveys or ineligible participants. The primary reason for exclusion was not meeting criteria for a myocardial infarction either because of missing or normal biomarker results, transfer patients without further interventions, or admission outside the study period. The median (IQR) number of days from discharge to survey completion at follow-up (IQR) was 31 (29–34) days.
Table 1 presents unadjusted and adjusted demographic, clinical, and laboratory data, overall and stratified by sex. The mean (SD) age of the respondents was 60.8 (13.7) years, which was similar to the overall trial population (Table I in the Data Supplement). Most respondents were men (62% compared with 76% in the overall trial because of the stratified random sampling frame in this study), and most presented with ST-segment–elevation myocardial infarction (63% compared with 65% in the overall trial). The median (IQR) time from symptom onset to arrival was 261 (120–885) minutes. Women were older (mean [SD] age, 64.0 [13.1] years versus 58.8 [13.6] years; adjusted P<0.01) and were less likely to present with ST-segment–elevation myocardial infarction (56% versus 68%; adjusted P<0.01) than men.
| Characteristics | N | Overall (n=1261) | Men (n=784) | Women (n=477) | P Value | |
|---|---|---|---|---|---|---|
| Unadjusted* | Adjusted† | |||||
| Age, mean (SD), y | 1261 | 60.8±13.7 | 58.8±13.6 | 64.0±13.1 | <0.01 | <0.01 |
| History of tobacco use, n (%) | 1261 | 360 (28.5) | 335 (42.7) | 25 (5.2) | <0.01 | <0.01 |
| History of diabetes mellitus, n (%) | 1261 | 581 (46.1) | 318 (40.6) | 263 (55.1) | <0.01 | <0.01 |
| Transferred from another facility, n (%) | 1261 | 530 (42.0) | 349 (44.5) | 181 (37.9) | 0.02 | 0.01 |
| No insurance, n (%) | 1261 | 953 (75.6) | 581 (74.1) | 372 (78.0) | 0.12 | 0.09 |
| ST-elevation myocardial infarction, n (%) | 1261 | 800 (63.4) | 535 (68.2) | 265 (55.6) | <0.01 | <0.01 |
| Symptom-to-door time, median (IQR), min | 1214 | 261 (120–885) | 240 (115–840) | 313 (135–960) | 0.02 | <0.01 |
| Body weight, mean (SD), kg | 1261 | 62.9±10.7 | 65.9±10.0 | 57.9±10.1 | <0.01 | <0.01 |
| Systolic blood pressure, mean (SD), mm Hg | 1261 | 141.2±29.1 | 139.0±27.9 | 144.8±30.7 | <0.01 | <0.01 |
| Heart rate, mean (SD), bpm | 1261 | 81.8±21.0 | 79.7±21.2 | 85.3±20.1 | <0.01 | <0.01 |
| Initial troponin, median (IQR), ng/mL | 671 | 1.23 (0.30–6.71) | 1.65 (0.34–10.00) | 0.88 (0.25–3.17) | <0.01 | 0.03 |
| Low-density lipoprotein cholesterol, mean (SD), mg/dL | 959 | 125.1±42.5 | 122.1±42.5 | 129.6±42.2 | <0.01 | 0.03 |
| Triglycerides, median (IQR), mg/dL | 959 | 115 (84–160) | 117 (82–170) | 113 (88–152) | 0.57 | 0.87 |
| Serum creatinine, median (IQR), mg/dL | 380 | 1.0 (0.9–1.3) | 1.1 (0.9–1.3) | 1.0 (0.8–1.2) | <0.01 | <0.01 |
| Fasting glucose, median (IQR), mg/dL | 807 | 135 (106–189) | 129 (104–180) | 143 (110–206) | <0.01 | 0.02 |
| Hemoglobin, mean (SD), mg/dL | 1236 | 13.1±2.2 | 13.8±2.0 | 11.9±1.8 | <0.01 | <0.01 |
| Intervention, n (%) | 1261 | 328 (26) | 175 (22) | 153 (32) | <0.01 | Nonestimable |
ACS QUIK indicates Acute Coronary Syndrome Quality Improvement in Kerala; and IQR, interquartile range.
*
Two sample t test, χ2 test, or Mann-Whitney U test.
†
Linear, quantile, or logistic regression with adjustment for time (step) and random cluster effect.
Table 2 displays the overall summary results from the Seattle Angina Questionnaire overall and by sex, and Table II in the Data Supplement displays the results within the subscale of each domain. More than 2 out of every 5 respondents (44%) experienced some angina during the month after hospitalization, but most of these (68% of respondents with angina; 27% of the total sample) had episodes of angina less than once a week. However, 1 out of every 10 respondents (10.6%) had weekly angina, and <1% of respondents had daily angina. Women had higher rates of weekly or daily angina compared with men (unadjusted angina frequency prevalence, 12.2% versus 9.9; adjusted P<0.01). Tables III and IV in the Data Supplement demonstrate unadjusted and adjusted results stratified by type of myocardial infarction and randomization status, which were largely similar. The respondents rated high median (IQR) scores for angina frequency (100.0 [80.0–100.0]), indicating minimal impact on quality of life, with similar unadjusted scores by sex. The median (IQR) physical limitation scale response was 58.3 (41.7–77.8), indicating limitations with moderate and high-intensity activity levels at 30-day follow-up. Women experienced greater physical limitations than men (median [IQR], 52.8 [38.9–72.2] for women versus 61.1 [44.4–80.6] for men; P<0.01). Figure 1 demonstrates physical limitation score results by subscale of the Seattle Angina Questionnaire across a range of activity levels. Treatment satisfaction was also high with a median (IQR) score of 81.3 (75.0–93.8), whereas overall quality of life was lower with a median (IQR) score of 66.7 (50.0–83.3). Both treatment satisfaction and overall quality of life scores were similar for men and women.
| Seattle Angina Questionnaire Component | N | Overall (n=1261) | Men (n=784) | Women (n=477) | P Value | |
|---|---|---|---|---|---|---|
| Unadjusted* | Adjusted† | |||||
| Any angina, n (%) | 1261 | 560 (44.4) | 338 (43.1) | 222 (46.5) | 0.23 | 0.07 |
| Angina frequency scale, median (IQR) | 1261 | 100.0 (80.0–100.0) | 100.0 (80.0–100.0) | 100.0 (80.0–100.0) | 0.11 | 0.51 |
| Angina frequency | 1261 | <0.01 | <0.01 | |||
| Daily | 7 (0.6) | 0 (0.0) | 7 (1.5) | |||
| Weekly | 134 (10.6) | 78 (9.9) | 56 (11.7) | |||
| Monthly | 419 (33.2) | 260 (33.2) | 159 (33.3) | |||
| None | 701 (55.6) | 446 (56.9) | 255 (53.5) | |||
| Physical limitation scale, median (IQR)‡ | 1184 | 58.3 (41.7–77.8) | 61.1 (44.4–80.6) | 52.8 (38.9–72.2) | <0.01 | <0.01 |
| Treatment satisfaction scale, median (IQR) | 1261 | 81.3 (75.0–93.8) | 81.3 (75.0–93.8) | 81.3 (75.0–93.8) | 0.67 | 1.00 |
| Overall quality of life scale, median (IQR) | 1261 | 66.7 (50.0–83.3) | 66.7 (50.0–83.3) | 66.7 (50.0–83.3) | 0.46 | 1.00 |
ACS QUIK indicates Acute Coronary Syndrome Quality Improvement in Kerala; IQR, interquartile range; and SAQ, Seattle Angina Questionnaire.
*
χ2 test or Mann-Whitney U test.
†
Quantile or logistic regression with adjustment for time (step) and random cluster effect.
‡
Per SAQ scoring instructions if the responses to any of the questions within the physical limitation score are 6=limited for other reasons or did not do the activity then the response is set to missing. The scoring uses a modified imputation to fill in the missing values based on the other responses to physical activity questions. If >4 items are missing, then the score for physical activity cannot be accurately calculated.
Figure 2 demonstrates variability of physical limitation (Figure 2A), angina frequency (Figure 2B), treatment satisfaction (Figure 2C), and quality of life (Figure 2D) scores by center, which demonstrates wide variability overall, with the largest variability seen in physical limitation and overall quality of life domains.
Table V in the Data Supplement displays univariable association of baseline demographics (including age and sex), presentation (including type of myocardial infarction), and randomized group allocation with SAQ scores, and Table 3 demonstrates these data adjusted for the Global Registry of Acute Coronary Events risk score covariates. After adjustment, older decade of age was associated with more physical limitations (difference, −4.1 per decade; P<0.01), greater angina frequency (difference,−0.9 score per decade; P<0.01), lower treatment satisfaction (difference, −0.7 per decade; P=0.01), and lower quality of life scores (difference, −0.7 per decade; P=0.05). Compared with women, men had less physical limitations (difference, 3.1; P=0.01) and less frequent angina (difference, 2.0; P=0.01). Patients who were transferred had lower levels of treatment satisfaction (difference, −1.7; P=0.03), and those randomized to the intervention group was associated with had better quality of life (difference, 4.2; P=0.03) but lower treatment satisfaction (difference, −2.9; P=0.05).
| Characteristics | Beta Coefficient (P Value)* | |||
|---|---|---|---|---|
| Physical Limitation | Angina Frequency | Treatment Satisfaction | Quality of Life | |
| Demographics and presentation | ||||
| Age, y | −0.41 (<0.01) | −0.09 (<0.01) | −0.07 (0.01) | −0.07 (0.05) |
| Male | 3.07 (0.01) | 2.00 (0.01) | 0.62 (0.44) | 0.98 (0.33) |
| History of tobacco use | 0.30 (0.82) | 0.14 (0.87) | 0.23 (0.80) | 0.30 (0.80) |
| History of diabetes mellitus | −0.93 (0.38) | −0.95 (0.18) | −0.99 (0.18) | −0.36 (0.70) |
| Transferred from another facility | 1.03 (0.38) | 0.07 (0.93) | −1.71 (0.03) | −0.07 (0.95) |
| No insurance | 0.40 (0.78) | 0.36 (0.71) | 0.09 (0.93) | 1.96 (0.13) |
| ST-segment–elevation myocardial infarction | 2.69 (0.03) | −0.44 (0.59) | 1.42 (0.09) | 0.87 (0.42) |
| Symptom-to-door time, h | 0.02 (0.45) | −0.02 (0.40) | 0.01 (0.70) | −0.05 (0.02) |
| Body weight, kg | −0.04 (0.49) | 0.10 (0.01) | 0.04 (0.25) | 0.11 (0.03) |
| Systolic blood pressure, mm Hg | 0.01 (0.54) | 0.01 (0.46) | −0.02 (0.17) | −0.02 (0.21) |
| Heart rate, bpm | −0.07 (0.01) | −0.01 (0.44) | −0.003 (0.86) | −0.01 (0.72) |
| Laboratory | ||||
| Initial troponin, mg/dL | 0.01 (0.82) | −0.04 (0.07) | 0.01 (0.47) | −0.04 (0.11) |
| Low-density lipoprotein cholesterol, mg/dL | −0.01 (0.33) | 0.004 (0.65) | 0.01 (0.29) | −0.01 (0.62) |
| Triglycerides, mg/dL | 0.02 (0.06) | 0.0002 (0.97) | 0.0001 (0.99) | 0.01 (0.16) |
| Serum creatinine, mg/dL | −1.45 (0.40) | −0.15 (0.88) | −1.84 (0.05) | −0.26 (0.85) |
| Fasting glucose, mg/dL | −0.02 (0.09) | 0.0003 (0.95) | −0.005 (0.48) | −0.01 (0.47) |
| Hemoglobin, g/dL | 0.45 (0.12) | 0.25 (0.19) | 0.25 (0.22) | −0.07 (0.79) |
| Intervention | −0.32 (0.88) | −1.57 (0.27) | −2.92 (0.05) | 4.15 (0.03) |
GRACE indicates Global Registry of Acute Coronary Events.
*
Linear model in the form of outcome: Seattle Angina Questionnaire domain, adjusted for step, random cluster, age, male, ST-segment–elevation myocardial infarction, systolic blood pressure, heart rate, incident heart failure, incident shock, and incident cardiac arrest.
Discussion
This study represents the largest report of health-related quality of life among myocardial infarction survivors in India. Our results demonstrate that >2 out of every 5 respondents (44%) in Kerala experience angina in the month after hospital discharge for acute myocardial infarction, although most have infrequent angina occurring less than once per week. Older individuals report greater physical limitations, greater angina frequency, and lower treatment satisfaction and overall quality of life. Women had greater physical limitations and angina frequency than men, whereas quality of life outcomes were similar across types of myocardial infarction. Most importantly, we identified wide variability in responses to the Seattle Angina Questionnaire across the participating hospitals, particularly related to physical limitations and overall quality of life. This observation represents an opportunity to learn from participating hospitals about strategies used to optimize health-related quality of life after acute myocardial infarction.
Differences in physical functioning between men and women may be related to differences in baseline characteristics, treatment, or a combination thereof. We tried to account for these differences in our multivariable models, but residual confounding may remain. However, we have previously demonstrated similar treatment and in-hospital clinical outcomes between men and women in Kerala, including death, reinfarction, stroke, heart failure, or cardiogenic shock, after adjustment for baseline differences in comorbidities and presentation.10
Individuals allocated to the ACS QUIK quality improvement intervention group had higher quality of life scores. We have previously demonstrated higher treatment rates, including reperfusion and antiangina medications at discharge, in the intervention group compared with the control group.6 Although the intervention did not target health-related quality of life, these findings may be true but may also be related to risk of recruitment bias, residual confounding between the groups, imprecision, or chance. It seems unlikely that increased treatment led to worse treatment satisfaction, but this question merits further research.
Previous studies evaluating health-related quality of life in India have included fewer than 100 participants each, and no study had more than 25 women.11–14 Three of these studies that evaluated quality of life were among military veterans after revascularization (2 studies) and patients with coronary artery disease and panic disorder treated at a north Indian government hospital (1 study), and they demonstrated more angina, lower quality of life, and lower treatment satisfaction than in participants in our study.12–14 However, our results were similar to baseline health-related quality of life estimates from a 2017 Indian trial evaluating the effect of ranolazine among individuals with microvascular dysfunction.11
Data from the 2003 to 2004 PREMIER (Prospective Registry Evaluating Myocardial Infarction: Events and Recovery, n=1815 participants) in the United States demonstrated that 27% and 24% of postmyocardial infarction patients had angina at 1- and 6-month follow-up, respectively,15 which were lower than angina rates from ACS QUIK. In the PREMIER study, individuals with persistent angina were 3× more likely to report low treatment satisfaction, even after multivariable adjustment. Among participants in the 2005 to 2008 TRIUMPH (Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients’ Health Status) registry (n=2915 participants), 29% of postmyocardial infarction survivors reported angina at 1-month follow-up (12% new angina; 17% persistent angina),16 which was again lower than results from ACS QUIK. Patients with angina in the TRIUMPH study were more likely to be younger, nonwhite, and uninsured than individuals without angina. The presence of angina at 1-month follow-up was also associated with increased risk for all-cause rehospitalization (persistent angina hazard ratio, 1.35; 95% CI, 1.06–1.71 or new angina at 30 days hazard ratio, 1.40; 95% CI, 1.08–1.82) and angina (persistent angina hazard ratio, 3.55; 95% CI, 3.05–4.13 or new angina hazard ratio, 3.38; 95% CI, 2.59–4.42) at 1-year follow-up.16 Whether or not a similar, longitudinal relationship exists between postdischarge angina and longer-term rehospitalization and angina among patients in Kerala is uncertain but seems plausible. In a subsample of the 2008 to 2012 VIRGO study (Variation in Recovery: Role of Gender on Outcomes of Young Acute Myocardial Infarction Patients) with preenrollment coronary artery disease (n=3501 total participants [67% women]; n=672 [65% women] with coronary artery disease), women demonstrated more physical limitations, more angina, less treatment satisfaction, and poorer quality of life than men.17 Among ACS QUIK participants, women had greater physical limitations and more angina than men, but other domains were similar between sexes.
Strengths and Limitations
Our study has several strengths, including being the largest study of health-related quality of life among survivors of acute myocardial infarction in India, particularly women, and using a translated, validated instrument designed for patients with coronary artery disease. However, our study also has limitations. First, our study was restricted to hospitals in Kerala and thus may not be representative of all of India, including states with lower per capita income. Second, we did not capture baseline health status and were thus not able to measure changes in health status over time. Third, we did not achieve our target sample because of low recruitment of underrepresented age-sex groups and expanding our sampling frame during the trial to include individuals in the intervention group. However, because the differences between the intervention and control groups were modest and because we were able to adjust for group allocation, the influence of this change is likely minimal. Fourth, the trial in which this substudy was embedded randomized on the cluster level yet recruited participants on the individual level, which raises the possibility of recruitment bias that may have influenced our results.
Conclusions
Angina is common after hospital discharge for patients with recent acute myocardial infarction in Kerala and warrants postdischarge follow-up for evaluation and management, although most individuals experience mild, infrequent angina. Although the rate of angina may be higher than previously reported in high-income country settings, the overall quality of life scores among ACS QUIK was similar to, if not higher than, previous studies though variability across hospitals is wide. However, older individuals and women have lower quality of life outcomes. The ACS QUIK quality improvement intervention improved health-related quality of life, although this comparison was not made across randomized groups. Additional research is needed to help explain the variability in quality of life across age, sex, and hospitals, in particular. Future research will help better understand the underlying reasons and translatable factors why some hospitals attain better health status outcomes in their patients. This research will help toward achieving the goal of improving the quality of life of patients after acute myocardial infarction in Kerala, India, and other low- and middle-income country settings.
APPENDIX A
Group Information: Cardiological Society of India Kerala Chapter Advisory Committee:
G. Vijayaraghavan, Kerala Institute of Medical Sciences; Ashokan Nambiar, Baby Memorial Hospital; Geevar Zachariah, Mother Hospital; Rajan J. Manjooran, Pushpagiri Medical College; S. Sivasankaran, Sree Chitra Tirunal Institute of Medical Science and Technology.
Trial Steering Committee:
Dorairaj Prabhakaran (co-chair), Centre for Chronic Disease Control/Public Health Foundation of India; Donald M. Lloyd-Jones (co-chair), Northwestern University; K. Srinath Reddy, Public Health Foundation of India; S. Harikrishnan, Sree Chitra Tirunal Institute of Medical Science and Technology; Robert O. Bonow, Northwestern University; Darwin R. Labarthe, Northwestern University; Sidney C. Smith Jr, University of North Carolina.
Data and Safety Monitoring Board:
Brahmajee Nallamothu (chair), University of Michigan; Thomas Alexander, Kovai Medical Center and Hospital; Karla Hemming, University of Birmingham; Simon Thom, Imperial College London; K.R. Sundaram, Amrita Institute of Medical Sciences; Lawton Cooper, National Heart, Lung, and Blood Institute.
Zonal Project Coordinators:
Divin Davies, WestFort Hi-Tech Hospital; Prasad Arumugan, Caritas Hospital, Aneesh T.C., P.R.S. Hospital.
Trial Sites, Investigators, and Coordinators:
Amala Medical College, Thrissur; Investigator: Dr Rajesh; Coordinator: Anoop P.T.; Amrita Institute of Medical Sciences & Research Center, Ernakulam; Investigator: Dr Natarajan; Coordinator: Mr Sujith Raj; Anathapurai Hospital, Thiruvananthapuram; Investigator: Dr Bahuleyan; Coordinator: Mr Jinbert; Aswini Hospital, Thrissur; Investigator: Dr Pramod; Coordinator: Mr Vineesh Varghese; Baby Memorial Hospital, Kozhikode; Investigator: Dr Nambiar; Coordinator: Dr Bindu; Bharath Heart Institute, Kottayam; Investigator: Dr Kathalankal; Coordinator: Mrs Susamma; Bishop Benziger Hospital, Kollam; Investigator: Dr Renga; Coordinator: Ms. Alphonsa; C.H. Memorial Hospital, Valanchery; Investigator: Dr Ibrahimkutty; Caritas Hospitals; Investigator: Dr Joseph; Coordinator: Mr Tony; Daya Specialty Hospital, Thrissur; Investigator: Dr Ullas; Coordinator: Ajmal K.A.; District Hospital, Palakkad; Investigator: Dr Siar; Coordinator: Pravya P.; District Hospital, Kollam; Investigator: Dr Syam; Coordinator: Mrs Sajitha; Dr Damodaran Memorial Hospital, Kollam; Investigator: Dr Robby; Coordinator: Mrs Prasanna; Elite Mission Hospital, Thrissur; Investigator: Dr Manikandan; Coordinator: Lekha M.P.; E.M.S. Hospital Perinthalmana; Investigator: Dr Somanathan; Gokulam Medical College, Thiruvananthapuram; Investigator: Dr Abhilash and Dr Binu; Coordinator: Mr Aneesh; Government Medical College Thrissur; Investigator: Dr Mathew and Dr Andrews; Coordinator: Mr Arun Gopi; Holy Cross Hospital, Kottayam; Investigator: Dr Chacko; Coordinator: Mr Libin; Indira Gandhi Cooperative Hospital, Ernakulam; Investigator: Dr Abraham; Coordinator: Ms. Alphonsa Rony; Irinjalakuda Co-operative Hospital; Investigator: Dr Ullas; Coordinator: Mr Midhun George; Jubilee Mission Hospital, Thrissur; Investigator: Dr Govindanunny; Coordinator: Mr Lance Frank William; Kannur Medical College, Kannur; Investigator: Dr Raveendran; Coordinator: Ms. Athira; Kerala Institute of Medical Science, Thiruvananthapuram; Investigator: Dr Vijayaraghavan; Coordinator: Mrs Kavitha; K.M.C.T. Heart Institute, Manassery; Investigator: Dr Saleem; Coordinator: Mr Joshy; Koyili Hospital, Kannur; Investigator: Dr Kumar; Coordinator: Ms. Alpha; K.V.M. Hospital, Cherthala; Investigator: Dr Venugopal; Coordinator: Mr Vipin; Lakshmi Hospital, Palakkad; Investigator: Dr Jayagopal; Coordinator: Devaki; Lakshmi Hospital, Ernakulam; Investigator: Dr Sasikumar; Lal Memorial Hospital, Irinjalakuda; Investigator: Dr Madhu; Lisie Hospital, Ernakulam; Investigators: Dr Abdullakutty, Dr Mathew; Coordinator: Ms. Serrin; Little Flower Hospital, Angamaly; Investigator: Dr Joseph; Coordinator: Mr Rajesh; Lourdes Hospital, Ernakulam; Investigator: Dr Sujith Kumar; Coordinator: Mrs Ria Sandeep; Medical College Hospital, Kozhikode; Investigator: Dr Haridas; Coordinator: Mrs Deepa; Medical College Hospital, Alappuzha; Investigators: Dr Sivaprasad, Dr Sreenivas, Dr Gagan; Medical College Thiruvananthapuram; Investigator: Dr Koshy; Coordinator: Dr Raji; Medical College, Kottayam; Investigator: Dr Jayaprakash, Dr Brijesh; Metro International Cardiac Centre, Kozhikode; Investigator: Dr Mustafa; Coordinator: Ms. Anooja; M.I.M.S. Heart, Kottakkal, Malappuram; Investigator: Dr Tahsin; Coordinator: Mr Pradeesh; Modern Hospital, Kodungallur; Investigator: Dr Ukken; Coordinator: Ms. Teena Sudheer; M.O.S.C.M. Hospital, Ernakulam; Investigator: Dr Punnoose; Coordinator: Mr Binoy Kurian; Mother Hospital, Limited, Thrissur; Investigator: Dr James; Coordinator: Dr James K.J.; N.I.M.S. Hospital, Thiruvananthapuram; Investigator: Dr Sreedharan; Coordinator: Mrs Anju Mohan; Pariyaram Medical College, Kannur; Investigator: Dr Sebastian; Coordinator: Mr Robin; P.R.S. Hospital, Thiruvananthapuram; Investigator: Dr Nair; Coordinator: Mr Aneesh; Pushpagiri Medical College, Thiruvilla; Investigator: Dr Manjooran; Coordinator: Mr Jacob; P.V.S. Memorial Hospital, Ernakulam; Investigator: Dr Blessan; Coordinator: Mrs Nisha; Rajah Hospital, Guruvayoor; Investigator: Dr Showjad; Coordinator: Dr Dhamoadharan; Ramdas Nursing Home, Perinthalmana; Investigator: Dr Ramadas; Coordinator: Mr Jobson; S.K. Hospital, Thiruvananthapuram; Investigator: Dr Suresh; Coordinator: Mrs Divy; S.H. Medical Centre Hospital, Kottayam; Investigator: Dr Chacko; Coordinator: Mrs Saranya; Samaritan Hospital, Pazhangad; Investigator: Dr Eapen; Coordinator: Mrs Sindhu; Santhi Nursing Home, Punnayoorkulam; Investigators: Dr Shaji, Dr Krishnan; Sree Chitra Tirunal Institute of Medical Sciences & Technology, Thiruvananthapuram; Investigators: Dr Harikrishnan, Dr Ajit; Coordinator: Mr Suresh; Sree Narayana Institute of Medical Science, Ernakulam; Investigator: Dr Menon; Coordinator: Mrs Nisha; St. James Hospital, Chalakudy; Investigator: Dr Mathew; St. Joseph Hospital, Dharmagiri Investigator: Dr Thomas; Coordinator: Sr. Betto; St. Martin De Porres Hospital, Cherukunnu; Investigator: Dr Muralidharan; St. Mary’s Hospital, Thodupuzha; Investigator: Dr Abraham; Sukuppuram Hospital, Edappal; Investigator: Dr Narayanan; Tellicherry Co-operative Hospital, Thalassery; Investigator: Dr Kumar; Coordinator: Dr Manoj; Thangam Hospital, Palakkad; Investigator: Dr Jayakumar; Coordinator: Mr Sagar Thampy; Travancore Medical College, Thiruvananthapuram; Investigator: Dr Abhilash; Coordinator: Mr Santhosh; WestFort Hi-Tech Hospital, Limited, Thrissur; Investigator: Dr E.B. Manoj; Coordinator: Mr Divin Davies.†
Acknowledgments
StatTag25 (v3.0; Chicago, IL) was used for the preparation of results in this article. StatTag facilitates reproducible research by embedding output from statistical programs (Stata, SAS, and R) in Microsoft Word documents. Code files used for generation of results can be downloaded at https://github.com/abigailbaldridge/ACS-QUIK. Drs Huffman, Kondal, and Zhao and A.S. Baldridge and M. Ali had full access to all study data and take responsibility for the integrity of the data and the accuracy of the data analysis.
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Information & Authors
Information
Published In
Circulation: Cardiovascular Quality and Outcomes
PubMed: 30755027
Copyright
© 2019 American Heart Association, Inc.
History
Received: 8 August 2018
Accepted: 11 January 2019
Published in print: February 2019
Published online: 13 February 2019
Keywords
Subjects
Authors
Disclosures
Dr Huffman receives support from the World Heart Federation to serve as its senior program advisor for the Emerging Leaders program, which is supported by unrestricted educational grants from Boehringer Ingelheim and Novartis with previous support from Bupa and AstraZeneca. He also receives funding from the American Heart Association, Verily, and AstraZeneca for work unrelated to this article. Dr. Huffman receives funding from the American Medical Association as an associate editor for JAMA Cardiology, which is unrelated to this work. The other authors report no conflicts.
Sources of Funding
The ACS QUIK trial (Acute Coronary Syndrome Quality Improvement in Kerala) was sponsored by the National Heart, Lung, and Blood Institute (R00 HL107749), Centre for Chronic Disease Control, Cardiological Society of India-Kerala Chapter, Northwestern Global Health Initiative, and Northwestern University Clinical and Translational Science Institute (UL1TR001422). The translation, validation, and license of the Seattle Angina Questionnaire was sponsored by CV Outcomes, Inc. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the article; or decision to submit the article for publication.
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- Quality of life after myocardial infarction in the pakistani population – insights from a single-center cohort study, BMC Cardiovascular Disorders, 24, 1, (2024).https://doi.org/10.1186/s12872-024-04283-2
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- Use of Natural Language Processing for Identification of Gender Differences in Acute Myocardial Infarction Presentation and Management in Pakistan, SSRN Electronic Journal, (undefined).https://doi.org/10.2139/ssrn.3978558
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