Physical and mental component summaries score of the SF-36 in coronary patients

Background: The aim of the study was to determine the clinical and sociodemographic factors related to the physical and mental components of the health-related quality of life (HRQL) in coronary patients. Methods: We studied 132 patients diagnosed with Acute Myocardial Infarction (AMI) and unstable angina admitted to a cardiology unit over a period of 18 months. The HRQL was assessed with the Short Form 36 Health Questionnaire (SF-36) and the presence of possible mental disorders was measured using the General Health Questionnaire (GHQ-28). In order to study the variables related to both physical and mental summary components of the SF-36, two multiple linear regression models were constructed with the physical (PCS) and the mental component summary (MCS) as outcome variables. Results: The GHQ-28 score 6 was the variable most associated with the lowest PCS in the patients studied. Moreover in the patients with a personal history of coronary heart disease (CHD), age tended to increase the PCS of the HRQL, whereas in those with no such history, age diminished the PCS score. For the MCS, not being married, being of female sex, having GHQ-28 scores 6 and being of younger age were the four variables most related to the lowest MCS score in the patients studied. Conclusion: Age, sex, marital status, personal history of CHD and the presence of a possible mental disorder were the factors most related to HRQL in the coronary patients studied. Focusing medical attention on these groups could contribute to improving their quality of life.     

Is the standard SF-12 Health Survey valid and equivalent for a Chinese population?

Introduction: Chinese is the worlds largest ethnic group but few health-related quality of life (HRQoL) measures have been tested on them. The aim of this study was to determine if the standard SF-12 was valid and equivalent for a Chinese population. Methods: The SF-36 data of 2410 Chinese adults randomly selected from the general population of Hong Kong (HK) were analysed. The Chinese (HK) specific SF-12 items and scoring algorithm were derived from the HK Chinese population data by multiple regressions. The SF-36 PCS and MCS scores were used as criteria to assess the content and criterion validity of the SF-12. The standard and Chinese (HK) specific SF-12 PCS and MCS scores were compared for equivalence. Results: The standard SF-12 explained 82% and 89% of the variance of the SF-36 PCS and MCS scores, respectively, and the effect size differences between the standard SF-36 and SF-12 scores were less than 0.3. Six of the Chinese (HK) specific SF-12 items were different from those of the standard SF-12, but the effect size differences between the Chinese (HK) specific and standard SF-12 scores were mostly less than 0.3. Conclusions: The standard SF-12 was valid and equivalent for the Chinese, which would enable more Chinese to be included in clinical trials that measure HRQoL.     

Validation testing of a three-component model of Short Form-36 scores

Objective

The two-component factor structure underlying Short Form-36 (SF-36) summary scores may not be valid worldwide. We studied a three-component model of SF-36 scores in Japan.

Study Design and Setting

The SF-36 scores came from representative samples of the population of Japan. Factor analysis and structural equation modeling were used. The two-component model gave physical component summary (PCS) scores and mental component summary (MCS) scores. The three-component model gave scores on the PCS, the MCS, and also on the third component, which we call the role component summary (RCS) score. These were evaluated with external criteria.

Results

In the three-component model, the RCS was strongly associated with the role-physical, social functioning, and role-emotional subscales, whereas the PCS and MCS were associated with the physical functioning and mental health subscales, as expected. The goodness-of-fit index was 0.945 for the three-component model and 0.935 for the two-component model. The PCS discriminated between groups stratified by comorbid conditions, and the MCS discriminated between groups stratified by psychological depression. Absence from work was associated with both PCS and RCS.

Conclusion

The three-component model is better than the two-component model, and it provides more useful PCS and MCS scores. Criteria for validation testing of the RCS are needed.     

Results from several population studies show that recommended scoring methods of the SF-36 and the SF-12 may lead to incorrect conclusions and subsequent health decisions

Purpose

To compare the measurement properties of the physical component summary (PCS) and mental component summary (MCS) scores of the SF-36 and SF-12 based on the traditional orthogonal scoring algorithms with the performance of the PCS and MCS scored based on structural equation model coefficients from a correlated model.

Methods

This study used three large-scale representative population studies to compare the measurement properties of the PCS and MCS scores of the SF-36 and SF-12 with the performance of the PCS and MCS scores based on structural equation models producing coefficients from a correlated model. We assessed the relationships of these scores with selected important mental health measures and chronic conditions from three representative Australian population studies that address clinical conditions of high prevalence and health service importance.

Results

Structural equation model scoring methods produced summary scores with higher correlations than the recommended orthogonal methods across a range of disease and health conditions. The problem experienced in using the orthogonal methods is that negative scoring coefficients are applied to negative z-scores for sub-scales, inflating the resulting summary scores. Effect sizes over a half of a standard deviation were common.

Conclusions

If health policy or investment decisions are made based on the results of studies employing the recommended orthogonal scoring methods then the expected outcome of such decisions or investments may not be achieved.     

Health-related quality of life in women and men one year after acute myocardial infarction

The purpose of the present study was, first, to detect possible changes in health-related quality of life (HRQL) over time and, second, to predict HRQL at 1year based on measures made 1 week and 5 months after a first-time acute myocardial infarction. There was an improvement in HRQL at 1year, as measured by the questionnaire 36-item Medical Outcomes Study Short-Form (SF-36), for both men and women as compared with the assessment 5 months after the acute myocardial infarction. However, the pattern was somewhat different for women and men. Women mainly reported increased scores on scales reflecting better mental health, whereas men, on the whole, demonstrated higher scores in the physical health domain. Depression (HAD) and fatigue were identified as early predictors of lower HRQL at the 1-year follow-up. Our conclusion is that early assessment of fatigue and depression is worthwhile, as they may indicate decreased HRQL in men and women 1year after first-time myocardial infarction.     

Impact of diagnosis of diabetes on health-related quality of life among high risk individuals: the Diabetes Prevention Program outcomes study

Purpose

The purpose of this study is to assess if diagnosis of type 2 diabetes affected health-related quality of life (HRQoL) among participants in the Diabetes Prevention Program/Diabetes Prevention Program Outcome Study and changes with treatment or diabetes duration.

Methods

3,210 participants with pre-diabetes were randomized to metformin (MET), intensive lifestyle intervention (ILS), or placebo (PLB). HRQoL was assessed using the SF-36 including: (1) 8 SF-36 subscales; (2) the physical component (PCS) and mental component summary (MCS) scores; and (3) the SF-6D. The sample was categorized by diabetes free versus diagnosed. For diagnosed subgroup, mean scores in the diabetes-free period, at 6 months, 2, 4 and 6 years post-diagnosis, were compared.

Results

PCS and SF-6D scores declined in all participants in all treatment arms (P < .001). MCS scores did not change significantly in any treatment arm regardless of diagnosis. ILS participants reported a greater decrease in PCS scores at 6 months post-diagnosis (P < .001) and a more rapid decline immediately post-diagnosis in SF-6D scores (P = .003) than the MET or PLB arms. ILS participants reported a significant decrease in the social functioning subscale at 6 months (P < .001) and two years (P < .001) post-diagnosis.

Conclusions

Participants reported a decline in measures of overall health state (SF-6D) and overall physical HRQoL, whether or not they were diagnosed with diabetes during the study. There was no change in overall mental HRQoL. Participants in the ILS arm with diabetes reported a more significant decline in some HRQoL measures than those in the MET and PLB arms that developed diabetes.     

Health-related quality of life during the bereavement period of caregivers of a deceased elderly person

Few studies have addressed the health-related quality of life (HRQL) impact of bereavement. The objective of this study was to evaluate the HRQL of the main caregiver after the death of a close elderly relative. 142 caregivers were invited to participate in a phone interview with the SF-36. General population SF-36 norms were used to calculate the gender and age standardised physical component summary (PCS) and mental component summary (MCS) scores. A MCS below 43 was used as an indicator of possible depression. Databases of several patient studies were additionally used to facilitate interpretation of results. 130 caregivers (91.5%) participated, the majority being women (80%), middle aged (56 years), and the spouse (22%) or son/daughter (56%) of the deceased person. Caregivers SF-36 scores were lower than expected for mental health, role emotional and social functioning. Their MCS was below that expected by 0.6 SD units, whereas their PCS was above by 0.2 SD. The proportion of caregivers with possible depression was 33.8%. First-degree family relationship with the deceased (OR=4.5), and lower age of the deceased (OR=3.8) were significantly associated (p<0.02) to a possible depression. The recent death of an elderly person is associated with significant emotional health impact on the caregiver.The members of the Dying Elderly in Catalonia Study Group are: Alonso J., Camp L., Florensa E. Gómez-Batiste X., González C., Mascaró J., Pujol R., Ramon I., Rebollo P., Riquelme M., Sáiz N., Santed S., Subirats. E., Vila T. and Vilagut G.     

International SF-36 reference values in patients with ischemic heart disease

Purpose

International reference data for the SF-36 health survey (version 1) are presented based on a sample of 5508 adult patients with ischemic heart disease.

Methods

Patients with angina, myocardial infarction and ischemic heart failure completed the SF-36. Data were analyzed by diagnosis, gender, age, region and country within region and presented as mean ± standard deviation (SD), minimum, maximum, 25th, 50th and 75th percentile of the physical (PCS) and mental component summary (MCS) measures.

Results

Mean PCS scores were reported as being more than one SD below the normal range (standardized mean of 50 ± 10) by more than half of the patient subgroups (59 %) with all of the mean MCS scores falling within the normal range. Patients with angina and patients with ischemic heart failure reported the poorest mean PCS scores with both diagnoses reporting scores more than one SD below the standardized mean. Females, older patients (especially >70 years) and patients from Eastern Europe reported significantly worse mean PCS scores than male, younger and non-Eastern European patients. The cardiac diagnosis had no effect on the mean MCS scores; however, females, younger patients (especially <51 years) and patients from Eastern Europe reported significantly worse mean MCS scores than male, older and non-Eastern European patients.

Conclusions

These international reference SF-36 values for patients with IHD are useful for clinicians, researchers and health-policy makers when developing improved health services.

     

Assessment of Reliability and Validity of SF-12v2 among a Diabetic Population

Objectives

To validate the Medical Outcomes Study Short Form version 2 (SF-12v2) in diabetic patients.

Health literacy and health-related quality of life in adults with type 2 diabetes: a longitudinal study

Purpose

To examine the association of health literacy (HL) with changes in health-related quality of life (HRQL) among patients with type 2 diabetes.

Methods

Data from a cohort study of type 2 diabetes patients were used. HL was assessed using 3 previously validated screening questions and HRQL using the EQ-5D-5L and SF-12 [physical and mental composite summary scores (PCS, MCS)]. The associations of baseline HL with changes in EQ-5D, PCS, and MCS scores over 1 year and with directions of changes (no change; declined; improved) were examined. Missing data were handled with multiple imputation and sensitivity analyses.

Results

Average age of participants (N = 1948) was 64.6 ± 10.9 years, 45 % were female, and 12.6 % had inadequate HL. Participants had mean decrements of 0.01 in EQ-5D, 1.0 in PCS, and 1.2 in MCS over 1 year. In adjusted analysis, HL was not associated with changes in EQ-5D over 1 year (β = 0.01, P = 0.146); however, patients with adequate HL had 2.1 points greater increase in PCS (P < 0.001) and 3.1 points in MCS (P < 0.001) compared to those with inadequate HL. Patients with adequate HL were less likely to have a decline in EQ-5D (RR 0.66; 95 % CI 0.44, 0.98), PCS (RR 0.51; 95 % CI 0.34, 0.76), and MCS (RR 0.49; 95 % CI 0.33, 0.72) compared to those with inadequate HL. Patients with adequate HL were more likely to have an improvement in MCS compared to those with inadequate HL (RR 1.78; 95 % CI 1.04, 3.04); such associations were not observed for PCS or EQ-5D. All results were robust in sensitivity analyses.

Conclusions

Inadequate HL was independently associated with worsening HRQL in adults with type 2 diabetes, particularly in the mental health domain.

     

Health-related quality of life in patients with interstitial cystitis/bladder pain syndrome and frequently associated comorbidities

Purpose

To estimate the association of chronic non-urologic conditions [i.e., fibromyalgia (FM), chronic fatigue syndrome (CFS), and irritable bowel syndrome (IBS)] with health-related quality of life (HRQOL) in patients with interstitial cystitis/bladder pain syndrome (IC/BPS).

Methods

A total of 276 women with established diagnoses of IC/BPS completed a telephone interview which included demographics, self-reported medical conditions, the SF-36 health survey, and the interstitial cystitis symptom index (ICSI). Multivariate linear regression analysis was used to identify correlates of SF-36 physical and mental component summary scores.

Results

Mean patient age was 45.1 (SD 15.9) years, and 83 % of the subjects were white. Mean values for the SF-36 Physical Component Score (PCS) and Mental Component Score (MCS) means were 39 (SD 14) and 45 (SD 12), respectively, indicating significant HRQOL reductions. Mean ICSI score was 11.27 (SD = 4.86). FM and IBS were significantly associated with worse SF-36 scores: ?8 points on the PCS (p < 0.001) and ?6 points on the MCS (p < 0.001). CFS and the presence of other pelvic conditions (overactive bladder, vulvodynia, endometriosis) were not significantly associated with SF-36 PCS and MCS scores.

Conclusions

In patients with IC/BPS, the presence of FM, CFS, and IBS has a significant association with HRQOL, equivalent in impact to the bladder symptoms themselves. These results emphasize the importance of a multidisciplinary approach to treating patients with IC/BPS and other conditions.     

Health-related quality of life deficits associated with diabetes and comorbidities in a Canadian National Population Health Survey

Objective: To assess the impact of comorbid heart disease, stroke and arthritis on health-related quality of life (HRQL) in people with diabetes in the general Canadian population. Methods: Data were collected as part of the 1996–1997 Canadian National Population Health Survey. HRQL was assessed using overall Health Utilities Index Mark 3 (HUI3) and single attribute utility scores. Respondents (N=66,093) were classified into 1 of 16 groups based on the presence or absence of diabetes, heart disease, stroke, and arthritis, in all possible combinations and HRQL scores were compared using analysis of covariance. Results: Overall HUI3 scores for respondents with diabetes alone (0.88, 95 CI: 0.87–0.89) were lower than controls (0.92 95 CI: 0.92–0.92, p<0.001). Overall HUI3 scores for diabetes in combination withheart disease (0.77, 95 CI: 0.74–0.79), arthritis (0.78, 95 CI: 0.77–0.79) or stroke (0.79, 95 CI: 0.74–0.85) were considerably lower than diabetes alone. Triplets of comorbidities were associated with overall HRQL deficits of approximately 0.26–0.30, relative to controls. Conclusions: The illness burden experienced by individuals with diabetes is not only associated with diabetes itself, but largely with comorbid medical conditions.     

A comparison of SF-36 summary measures of physical and mental health for women across the life course

Background

Physical and mental component summary scores (PCS and MCS, respectively) are often used to summarise SF-36 quality of life subscales. This paper investigates PCS and MCS across the life course and compares the trajectories obtained from two different methods of calculation.

Methods

The Australian Longitudinal Study on Women’s Health is a population-based study with three cohorts of women and SF-36 surveys taken at multiple time points. Scoring coefficients for each component score were determined using factor analysis with uncorrelated (orthogonal) and correlated (oblique) rotation at the baseline survey, which were then used to compute correlated and uncorrelated PCS and MCS scores at each survey (scaled to have mean of 50 and standard deviation of 10 at baseline).

Results

For both methods, PCS declined progressively across the lifespan, while MCS rose in young and mid-age women to a peak and subsequently declined in later life. Differences were apparent between correlated and uncorrelated scores, most notably for MCS in the older cohort, where correlated MCS reached 54.6 but still less than uncorrelated MCS, with a random effects model indicating 1.63 (95 % confidence intervals 1.58–1.67) units difference; it then declined to a score of 51.2 by the last survey and the difference widened to 3.44 (3.38–3.50) units compared with the uncorrelated MCS.

Conclusions

PCS and MCS have distinct trajectories through life, with differences in results from correlated and uncorrelated component summary scores. The divergence is most notable with MCS, especially for older women, suggesting that correlated MCS and PCS should be used when examining change in health over time in this age group.     

Health-related quality of life of among elders in rural China: the effect of widowhood

Purpose

China has an enormous and rapidly growing population of widowed elders. Little is known about how losing a spouse affects elders’ health-related quality of life (QOL), especially in the rural areas where most Chinese elders live. This article analyzes QOL data collected in 2014 among rural Chinese elders to address this question.

Methods

SF12 questionnaires and information about individual and household characteristics were collected from 3053 elders aged 60 and above in rural China. We compared the physical component summary (PCS) and mental component summary (MCS) scores between 1925 married elders and 1060 widowed elders in a bivariate model stratifying by gender and age group and in a general factorial ANOVA multivariate analysis that examined and controlled for other predictors of PCS and MCS scores including education, chronic disease, and family and household factors.

Results

Widowed male and female elders’ physical health and mental health were in decline with age. Widowed men had lower PCS and MCS scores than married men. Widowed women also had lower PCS scores, but differences in MCS scores did not reach statistical significance. In multivariate analysis, widowhood was associated with lower PCS and MCS scores overall. Support from children was associated with better QOL and, based on interaction analysis, appeared to mitigate negative effects of widowhood.

Conclusions

Widowed rural elders in China have lower physical and mental quality of life than their married counterparts. These elders rely on their children for care, and a supportive family is associated with better QOL.

     

Normative data of the SF-12 health survey with validation using postmyocardial infarction patients in the Dutch population

Objective  To gain Dutch population norms for the Short Form-12 (SF-12), a generic health status questionnaire, in a random sample of the general population and to validate these in postmyocardial infarction (MI) patients. Methods  2,301 respondents from the general population and 459 post-MI patients completed the Short Form-36 (SF-36), which was used to calculate SF-12 scores. Results  The SF-12 summary scores correlated highly with SF-36 summary scores, demonstrating that these scores explain the same amount of variance in health status. Significant sex differences (P < .001) existed for both the physical component summary (PCS) and the mental component summary (MCS). Multivariate analysis of variance showed a main effect of age in oblique (PCS-12: P < .001; MCS-12: P < .001) and orthogonally rotated PCS scores (PCS-12_uc: P < .001; MCS-12_uc: P = .07). As expected, post-MI patients reported statistically significant and clinically relevant poorer mental (P < .001) and physical functioning (P < .001). Differences were less pronounced for MCS and PCS derived from orthogonal rotation data. When controlling for covariates, MI did not significantly affect PCS-12_uc anymore in orthogonally rotated data, while PCS-12_uc was affected by fewer covariates compared with PCS-12. Conclusions  This study presents Dutch population norms for the SF-12 in a large random population sample obtained from both oblique and orthogonal PCA rotation methods, revealing systematic differences between the results based on these two methods. Furthermore, this study demonstrates the discriminative validity of the SF-12 by showing that post-MI patients differ significantly from the normative population on PCS-12 scores.     

Comparing SF-36 scores across three groups of women with different health profiles

Background: The widespread use of the Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36) facilitates the comparison of health-related quality of life (HRQL) across independent studies. Objectives: To compare the scores of eight scales and two summary scales of the SF-36 across participants in the Womens Healthy Eating and Living (WHEL) trial, the Womens Health Initiative-Dietary Modification trial (WHI-DM), and the MOS, and to illustrate the use of effect sizes for interpreting the importance of group differences. Methods: WHEL and WHI-DM are both multi-center dietary interventions; only data from the UC Davis sites were used in our study. WHEL participants had a recent history of breast cancer, WHI-DM participants were healthy, postmenopausal women, and women in the MOS had a history of hypertension, diabetes, heart disease, or depression. General linear models were used to identify statistically significant differences in scale scores. Meaningful differences were determined by effect sizes computed using a common within-group standard deviation (SD) and SDs from normative data. Results: After adjusting for age and marital status, SF-36 scores for the WHI-DM and WHEL samples were similar and both had statistically significantly higher scores than the MOS sample. Relative to the WHEL or WHI-DM studies, MOS scores for scales related to the physical domain were clearly meaningfully lower whereas scale scores related to the mental health domain were potentially meaningfully lower. Conclusions: The HRQL of breast cancer survivors is comparable to that of healthy women and better than that of women with chronic health conditions, particularly with respect to physical health. This study illustrated the use of ranges of effects sizes for aiding the interpretation of SF-36 scores differences across independent studies.     

Biopsychosocial factors predict quality of life in thoracolumbar spine surgery

Purpose

Surgical intervention is a treatment option for various spinal pathology but many patients report no improvement or even an exacerbation of symptoms like pain. This study examined the association of preoperative (pre-op) biopsychosocial risk factors with poor quality of life at 2 and 6 months using hierarchical models controlling demographic and medical variables.

Method

Participants undergoing thoracolumbar spine surgery (N = 214) were provided with questionnaire packages to complete pre-op, at 2 and at 6-month postoperative clinical follow-ups (i.e., demographics, psychosocial measures, SF-12, medical, and clinical measures). The surgeon recorded surgical measures.

Results

Examining the pre-op period only, greater age and medication use (for back symptoms) were associated with poorer physical quality of life [physical component summary score (PCS)], while greater catastrophizing, depression, and lower social support were associated with poorer mental QoL [mental component summary score (MCS)]. Lower preoperative PCS, social support, and greater kinesiophobia were associated with diminished PCS at 2-month. Higher pre-op MCS and higher social support was associated with better MCS at 2-month. Poorer PCS at 6-month was associated with older age and low social support, while diminished MCS was associated with lower pre-op social support, MCS, and longer time in the operation room. Preoperative kinesiophobia partially mediated the relationship between pre-op PCS and 2-month PCS. Age partially mediated the relationship between pre-op PCS and at 6-month. For MCS, social support was the lone partial mediator of baseline MCS and both 2 and 6-month MCS.

Conclusion

These results show that preoperative psychosocial variables are significantly associated with poorer postoperative health-related QoL outcomes following spinal surgeries, supporting a biopsychosocial pre-op care map.

     

Association of patient demographics on quality of life in a sample of adult patients with cardiac arrhythmias

Purpose

Identify predictors of quality of life (QOL) in patients with any form of cardiac arrhythmia (CA).

Methods

Data from the Medical Panel Expenditure Survey were analyzed from 2004 to 2009. Patients aged ≥18 with any form of CA (identified via ICD-9-CM codes) were included. Primary outcomes included the physical and mental component scores (PCS and MCS) of the Short-Form 12 version 2 (SF-12) and EuroQoL-5D (EQ-5D) utility scores (US version). Patient demographics included insurance status, urban status, geographical region, federal poverty level, education, comorbidities, and disease-related risk factors of CA.

Results

Approximately 5,750,440 individuals had CA. Non-Hispanic Whites had the highest SF-12 MCS (mean 50.9; p < 0.001 across racial groups) and utility scores (mean 0.76; p < 0.001 across racial groups). Patients with both private and public insurance had significantly higher PCS (p = 0.001) and MCS (p < 0.001) in comparison with patients only covered by public insurance. Patients on antiarrhythmic agents had higher SF-12 MCS (51.4 vs. 48.4; p < 0.001) compared to individuals not on antiarrhythmic agents.

Conclusions

Significantly lower QOL existed in specific subpopulations (e.g., patients with only public health insurance, racial/ethnic minorities, and those not exposed to antiarrhythmic agents) within the CA population.     

Health-related quality of life in a rare disease: Hereditary hemorrhagic telangiectasia (HHT) or Rendu–Osler–Weber Disease

The levels of the health-related quality of life (HR-QoL) were analyzed in hereditary hemorrhagic telangiectasia (HHT) patients. The Short Form-36 Health Survey (SF-36) was administered to 50 HHT patients and scores were compared to a cohort of 2301 normal subjects. Clinical variables were patient age, illness duration, number of epistaxis episodes in the previous year and hemoglobin levels. Physical functioning, physical role limitations, bodily pain, social functioning, emotional role limitations and the physical component scores were lower among females. In multivariable analyses increasing age was related to lower physical functioning (P<0.04), physical role limitations (P<0.008), bodily pain (P<0.05) and emotional role limitations (P<0.01), while higher hemoglobin levels improved physical functioning(€P<0.03). The number of epistaxis episodes was negatively associated with physical role limitations (€P<0.009), vitality (P<0.002), social functioning (P<0.001), physical component summary (€P<0.001) and bodily pain (P<0.01). Illness duration was negatively related to the mental component summary (P<0.004). HHT patients had a lower HR-QoL with respect to normal controls in all domains except for bodily pain. Females had lower scores for several domains. Epistaxis was the most important clinical variable.     

Use of the Short Form-36 to Detect the Influence of Upper Gastrointestinal Disease on Self-Reported Health Status

Patient-centred outcome measures such as the Short Form-36 (SF-36) have been developed to assess the impact of ill health and medical interventions on self-reported health status. The objective of the study was to assess the impact of gastrointestinal disease upon health status as measured by the SF-36 physical and mental health component scores (PCS and MCS) and to assess whether these component scores might be an appropriate outcome measure for use in clinical research in gastroenterology. The subjects were 364 patients aged between 18 and 64 years who had been prescribed proton pump inhibitors (PPIs) by general practitioners in Oxfordshire. The general practices participating identified patients who had been prescribed PPIs. The data were abstracted from the general practice medical records of these patients concerning gastrointestinal diagnoses and other prescribed medications. The patients were sent the SF-36 questionnaire by post and the PCS and MCS scores were derived, which were adjusted for age and sex and compared with the scores of the general population of the Oxford region. Co-morbidity was assessed by the extent to which non-gastric medications were also used. The commonest diagnoses were oesophagitis/gastro-oesophageal reflux and indigestion. People with these diagnoses had significantly lower health status than the general population. Differences persisted when the results were controlled for the possible effects of co-morbidity. It was concluded that the SF-36 is sensitive to the impact of gastrointestinal disease on health status. This revised version was published online in June 2006 with corrections to the Cover Date.