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Citation: Lyons RA, Perry HM, Littlepage BN, Evidence for the validity of the Short-form 36 Questionnaire (SF-36) in an elderly population., Age Ageing 23: 3, 182-4, May, 1994.
The objective of this study was to determine whether the Short-form 36 Health Status Questionnaire (SF-36) is suitable for use in an elderly population. The SF-36 was administered by interview to a random sample of 827 adults from West Glamorgan. Among the 216 adults aged 65 and over the data were 98.8% complete. Evidence for a high degree of internal consistency was good with Cronbach's alpha statistic exceeding 0.8 for each parameter. The evidence for construct validity was also good with the SF-36 distinguishing between those with and without markers of poorer health. The SF-36 is suitable for use with an elderly population when used in an interview setting.
Citation: Jenkinson C, Wright L, Coulter A, Criterion validity and reliability of the SF-36 in a population sample., Qual Life Res 3: 1, 7-12, Feb, 1994.
This study aimed to determine the criterion validity of the Short Form 36 health survey questionnaire (SF-36) in a large community sample, and to explore the instrument's internal consistency and validity in groups reporting different levels of ill-health. A postal survey was undertaken using a questionnaire booklet, containing the SF-36 and a number of other items concerned with lifestyles and illness. The questionnaire booklet was sent to 13,042 randomly selected subjects between the ages of 18-64 years, drawn from Family Health Services Authority (FHSA) computerized registers for Berkshire, Buckinghamshire, Northamptonshire and Oxfordshire. This paper is based upon the 9332 (72%) responses gained. Scores for the functional status and well-being scales of the SF-36 were used as outcome measures. The response rate for the questionnaire booklet was 72%. Internal consistency of domains was found to be high, both for the sample as a whole, and when broken down by specific subgroups. Criterion validity was assessed by comparing scores for the seven multi-item dimensions assessing functional status and well being with a single global health question. The global question was the first item of the SF-36 and asks respondents to evaluate their health 'overall'. Statistically significant trends were observed for decreasing SF-36 scores (i.e., those indicating greater health problems) with worsening self-rated general health. These results provide further psychometric evidence for the use of the SF-36 when used with groups reporting varying extents of ill-health.
Citation: Lyons RA, Fielder H, Littlepage BN, Measuring health status with the SF-36: the need for regional norms., J Public Health Med 17: 1, 46-50, Mar, 1995.
BACKGROUND: Normative data on SF-36 scores in populations from Oxford and Aberdeen have recently been published. It has been suggested that such data provide suitable normative values for the UK population. However, other indices of health vary considerably across regions, and tend to be worse in areas such as South Wales. The objective of this study was to determine whether population SF-36 scores in West Glamorgan differ from scores from other parts of the United Kingdom. METHOD: The SF-36 health status questionnaire was administered to two random samples of adults aged 20-89 years, drawn from the West Glamorgan Family Health Services Authority register. One sample (n = 919) received postal questionnaires and those in the other sample (n = 1201) were interviewed in their own homes. Normative data from this study were compared with published data from other areas of the United Kingdom. RESULTS: SF-36 population scores were significantly lower in the two West Glamorgan samples; this was not due to differences in age, sex, social class, or response rates. CONCLUSION: Health status in West Glamorgan, as measured by the SF-36, is lower than in Oxford or Aberdeen. A national study would be required to provide appropriate normative data for the UK population.
Citation: Schneider B, Varghese RK, Scores on the SF-36 scales and the Beck Depression Inventory in assessing mental health among patients on hemodialysis., Psychol Rep 76: 3 Pt 1, 719-22, Jun, 1995.
45 patients on hemodialysis were administered both the Medical Outcomes Study SF-36 and the Beck Depression Inventory. The Mental Health Inventory subscale scores of the SF-36 were regressed stepwise on the Role Emotional subscale scores of the SF-36 and the Beck inventory. 46% of the variance in the MHI-5 scores was accounted for by age category and the other two measures of emotional status. Age category was not significant. Discussion includes the potential utility of the combination of inventories in assessing mental health among patients on hemodialysis.
Citation: Alonso J, Prieto L, Anto JM, [The Spanish version of the SF-36 Health Survey (the SF-36 health questionnaire): an instrument for measuring clinical results], Med Clin (Barc) 104: 20, 771-6, May 27, 1995.
BACKGROUND: The present study, performed within the International Quality of Life Assessment project (including researchers from 15 countries) presents preliminary results of the process of adaptation of the SF-36 to be used in Spain. METHODS: The adaptation was based on the translation/back-translation methodology. Meetings of translators, researchers and patients were organized in order to produce successive versions. A study involving 47 individuals was carried out to assess the relative value (through a visual analogue scale) of each response choice of the questionnaire items. Finally, internal consistency and reproducibility of the Spanish version of the SF-36 was assessed by administering the questionnaire to 46 patients with stable coronary heart disease in two different occasions 2 weeks apart. RESULTS: The average ratings of equivalence of the translated version with the original were high regardless of the difficulty of translation. The rank ordering of mean scores for each responses choice agreed with the ranking assigned in the questionnaire in all cases. Cronbach's Alpha was higher than 0.7 for all dimensions (range: 0.71-0.94) except for Social Functioning scale (alpha = 0.45). Intraclass correlation coefficients between both administrations of the questionnaire ranged from 0.58 to 0.99. CONCLUSIONS: The adaptation process of the SF-36 has concluded with an instrument apparently equivalent to the original and with an acceptable level of reliability. Nevertheless, other basic characteristics of the adapted questionnaire (i.e. validity and sensitivity to changes) should be also assessed.
Citation: Hayes V, Morris J, Wolfe C, Morgan M, The SF-36 health survey questionnaire: is it suitable for use with older adults?, Age Ageing 24: 2, 120-5, Mar, 1995.
An Anglicized version of the SF-36, a recently developed generic health status measure, was tested among people aged 65 years and over in hospital out-patient and general practice settings as both a self-completed and interview-administered instrument. The SF-36 was quick to complete, with 84% completed in 10 minutes or less (median time 8 minutes), while the distribution of scores provided further evidence of its sensitivity and validity. As an interview-administered instrument the SF-36 was acceptable among all age groups, although 32% of out-patients and 10% of general-practice patients, consisting predominantly of people aged 75 years and over with poor physical or mental health scores, felt unable to self-complete the questionnaire. In addition, 26% of respondents missed out at least one of the 36 statements, with missing items being significantly related to older age and self-completion. Missing responses were mainly concentrated on a small number of questions whose emphasis on work or vigorous activities meant that they were frequently regarded as not applicable by elderly people. Suggested modifications to these questions for elderly respondents are given. With these changes the SF-36 is regarded as suitable for use as a self-completed questionnaire among the younger age group of elderly people, although some assistance may often be required by people aged 75 years and over and especially those with poor physical or mental health.
Citation: Bousquet J, Knani J, Dhivert H, Richard A, Chicoye A, Ware JE Jr, Michel FB, Quality of life in asthma. I. Internal consistency and validity of the SF-36 questionnaire., Am J Respir Crit Care Med 149: 2 Pt 1, 371-5, Feb, 1994.
Asthma is a chronic disease in which social life is altered. The importance of restrictions on social life may be greater in severe asthma or when symptoms are not adequately controlled. General scales of quality-of-life (QOL) may be used to detect the importance of social life impairment, but it is not yet known whether the scores of such QOL measures are reliable and valid in asthmatic patients. A study was carried out in 252 patients with asthma of variable severity (FEV1 ranging from 25 to 131% of predicted) to assess the validity of a general QOL scale, the first French version of the SF-36 health status questionnaire (SF-36). This is based on 36 items selected to represent nine health concepts (physical, social, and role functioning; mental health; health perceptions; energy or fatigue; pain; and general health). All nine SF-36 category scores were highly significantly correlated with the severity of asthma assessed by the clinical score of Aas (p < 0.0007 to p < 0.0001). Eight SF-36 category scores were highly significantly correlated with FEV1 (p < 0.003 to p < 0.0001). A high internal reliability of SF-36 was found using the alpha coefficient of Cronbach (0.91 for the whole questionnaire). The SF-36 questionnaire is valid and reliable in asthma and can therefore be used to examine QOL in asthmatic and nonasthmatic patients and to determine to what extent asthma impairs social life.
Citation: Beusterien KM, Steinwald B, Ware JE Jr, Usefulness of the SF-36 Health Survey in measuring health outcomes in the depressed elderly., J Geriatr Psychiatry Neurol 9: 1, 13-21, Jan, 1996.
Longitudinal data from a clinical trial were analyzed to evaluate the usefulness of the SF-36 Health Survey in estimating the impact of depression and changes in severity over time on the functional health and well-being of 532 patients, 60 to 86 years of age, who met DSM-III-R criteria for major depressive disorder. The Hamilton Depression Rating Scale, the Clinician's Global Impression of Severity and Improvement, and the Geriatric Depression Scale were used to define clinical severity and changes in severity over a 6-week period. Answers to SF-36 questions tended to be complete and to satisfy assumptions underlying methods of scale construction and scoring. As hypothesized, the SF-36 Mental Health Scale and Mental Component Summary measure, shown in previous studies to be most valid in measuring differences in mental health, exhibited the strongest associations with severity of depression in cross-sectional analyses and were most responsive to changes in severity in longitudinal comparisons. We conclude that the SF-36 Health Survey is useful for estimating the burden of depression and in monitoring changes in functional health and well-being over time among the depressed elderly.
Citation: McCallum J, The SF-36 in an Australian sample: validating a new, generic health status measure., Aust J Public Health 19: 2, 160-6, Apr, 1995.
The SF-36 is a self-reported, 36-item, generic measure of health status that has been validated for adult age groups in the United States, the United Kingdom and in some non-English-speaking countries. The Australian Bureau of Statistics used it in the 1995 National Health Survey and it has been used in health status measurement, in monitoring health outcomes and in clinical trials. The validity of the SF-36 was examined in the National Centre for Epidemiology and Population Health Record Linkage Study using a sample of 555 respondents to the National Heart Foundation Risk Factor Prevalence Survey in 1989; they were followed up in 1992. Items chosen for the scale had been used in health status assessment and had stood the test of time. The health concepts measured demonstrated good internal consistency. The eight scales of the SF-36 formed factors as predicted in the general health dimensions of physical and mental health. The component scales of the SF-36 demonstrated good discrimination between people with and without health conditions, including those with medical and those with psychiatric types of conditions. Although the SF-36 was a valid measure of general health status among Australian respondents, further work is needed to establish clinical validity and to produce population norms for Australia. Use of the SF-36 will allow Australian and international comparison of health status from the point of view of the users of health services.
Citation: O'Dea D, Kokaua J, Wheadon M, SF-36 health status questionnaire [letter], J Epidemiol Community Health 49: 6, 647, Dec, 1995.
Citation: McGuigan FX, Hozack WJ, Moriarty L, Eng K, Rothman RH, Predicting quality-of-life outcomes following total joint arthroplasty. Limitations of the SF-36 Health Status Questionnaire., J Arthroplasty 10: 6, 742-7, Dec, 1995.
A group of 114 patients undergoing total hip and knee arthroplasty were evaluated to assess the effect of total joint arthroplasty on quality of life, as measured by the SF-36 Health Status Questionnaire, and to determine the predictive relationship between preoperative and postoperative scores. A highly significant improvement was seen comparing preoperative with postoperative scores at 2 years for physical function, social function, physical role function, emotional role function, mental health, energy, and pain. Despite a significant change in health status (P < or = .001), no change was seen in the patient's health perception (P = .61). Regression analysis failed to indicate a predictive relationship between preoperative and postoperative scores for any scale. Total joint arthroplasty dramatically improves the quality of life and function of patients afflicted with arthritis; however, because of the poor ability of the SF-36 to predict postoperative improvement on an individual basis, it cannot be used alone to determine treatment selection.
Citation: Hollingworth W, Mackenzie R, Todd CJ, Dixon AK, Measuring changes in quality of life following magnetic resonance imaging of the knee: SF-36, EuroQol or Rosser index?, Qual Life Res 4: 4, 325-34, Aug, 1995.
Evidence suggests that magnetic resonance imaging (MRI) allows accurate diagnosis of meniscal and ligamentous injuries of the knee. However the link between improved diagnosis through MRI and improved patient quality of life (QOL) has yet to be shown. Previous studies aimed at establishing this link have found no significant improvements in health related quality of life (HRQOL) as measured by the Rosser classification and index. This paper presents the results of three HRQOL questionnaires (SF-36, Rosser and EuroQol) used to measure health change in 332 patients referred for MRI of the knee. Before imaging, patients reported poorer HRQOL than the general population on two of the three questionnaires (SF-36 and EuroQol). The same two questionnaires recorded significant improvements in patient health at six months, although patients' health had not yet reached that experienced in the general population. There was evidence to suggest that the index values attached to the Rosser classification made it unresponsive in this group of patients, which may have predisposed the null results of previous studies of the influence of MRI on HRQOL. Some evidence is provided to suggest that the EurolQol may be less responsive in assessing change in health status than the SF-36.
Citation: Jenkinson C, Lawrence K, McWhinnie D, Gordon J, Sensitivity to change of health status measures in a randomized controlled trial: comparison of the COOP charts and the SF-36., Qual Life Res 4: 1, 47-52, Feb, 1995.
This study compared the sensitivity to change of comparable dimensions of a multi-item multi-dimensional health status measure (the SF-36) with the equivalent single item domains on the Dartmouth COOP charts. One hundred and twenty nine patients were randomized to either day case laparoscopic surgery (n = 60) or open inguinal hernia repair (n = 69). Respondents completed the SF-36 and COOP charts at baseline (prior to surgery) and at follow up at 10 days and 6 weeks. Equivalent dimensions of physical functioning, mental health/emotional condition, social activities, pain and overall condition/general health on the two questionnaires were compared. Despite slightly different pictures of change provided by the physical functioning and 'overall condition/general health' dimensions the general picture of change provided by the two instruments was similar. At 10 days, patients who underwent open surgery reported far greater levels of dysfunction than those who underwent laparoscopic surgery on both questionnaires. At 6 weeks the pain dimension of both questionnaires indicated a large improvement from baseline, whilst no other domain on either questionnaire for either group indicated such improvement. The general picture of change provided by the two measures was similar. The results suggest that both the SF-36 and the COOP charts may prove suitable for the assessment of health perception outcomes in surgical clinical trials. Differences on certain domains were caused in large measure by the nature of the questions posed. The study once again highlights the importance of checking item content to determine the suitability of any particular measure for a given study.
Citation: Jenkinson C, Peto V, Fitzpatrick R, Greenhall R, Hyman N, Self-reported functioning and well-being in patients with Parkinson's disease: comparison of the short-form health survey (SF-36) and the Parkinson's Disease Questionnaire (PDQ-39)., Age Ageing 24: 6, 505-9, Nov, 1995.
The purpose of this paper was to document the impact of Parkinson's disease (PD) upon patients using both a generic health status measure (the Short-form 36 health survey questionnaire, SF-36) and a disease-specific measure (the 39-item Parkinson's Disease Questionnaire, PDQ-39). Comparing the results of the SF-36 in this population with a similar aged group selected randomly from two general practices it was evident that the disease has considerable impact on general levels of functioning and well-being. Furthermore, other areas not contained on the SF-36 were found to be relevant to PD patients. It is suggested that the disease-specific measure will be of value, ideally alongside a generic measure, in studies aimed at determining the impact of a treatment regimen upon PD patients, or to monitor the long-term progress of cohorts of patients with PD. The paper highlights the need for careful consideration of measures for evaluation.
Citation: Hunter DJ, McKee M, Black NA, Sanderson CF, Health status and quality of life of British men with lower urinary tract symptoms: results from the SF-36., Urology 45: 6, 962-71, Jun, 1995.
OBJECTIVES. To determine the extent to which urinary symptoms, and resulting bothersomeness interfere with daily activities and affect health status, as measured using the Medical Outcomes Study 36-item short form health survey (SF-36). METHODS. Postal population survey in a British health region of 217 men aged 55 years and over known to have reported mild, moderate, or severe lower urinary tract symptoms. Outcome measures are self-reported urinary symptoms, their bothersomeness, general health status, and quality of life (measured using the SF-36). RESULTS. Response rate among eligible subjects was 84%. Depending on the activity, between 9% and 49% of men with moderate or severe urinary symptoms reported interference with some of their daily activities. Increasing symptom severity was associated with worsening physical role, social functioning, vitality, mental health, and perception of general health, and increasing bothersomeness was associated with worsening of all dimensions of general health status and quality of life. The association between these measures and bothersomeness was stronger than with symptom score. Compared with the general population, men bothered by their symptoms to the extent that they were a medium or a large problem have worse health status for all dimensions except physical functioning. CONCLUSIONS. The SF-36 demonstrates a deterioration in general health status and quality of life with increasing lower urinary tract symptoms and the extent to which those symptoms are bothersome. As such, it provides a generic measure of the burden of ill health arising from these symptoms at a population level. There is, however, considerable individual variation in the way that men respond to their symptoms.
Citation: Bousquet J, Bullinger M, Fayol C, Marquis P, Valentin B, Burtin B, Assessment of quality of life in patients with perennial allergic rhinitis with the French version of the SF-36 Health Status Questionnaire., J Allergy Clin Immunol 94: 2 Pt 1, 182-8, Aug, 1994.
BACKGROUND AND AIM: Perennial allergic rhinitis may impair social life. General scales of quality of life (QOL) are used to detect the importance of social life impairment, but the reliability and validity of QOL measures should be tested in patients with perennial allergic rhinitis. The extent to which QOL scores differ in patients with rhinitis and healthy subjects is unknown. METHODS: A cross-sectional study was carried out in 111 patients with moderate to severe perennial allergic rhinitis and 116 healthy subjects to assess the validity of a general QOL scale, the SF-36 Health Status Questionnaire. This scale is based on 36 items selected to represent nine health concepts (dimensions). The internal reliability of each dimension of the questionnaire was examined. The differences in QOL scores between patients with rhinitis and healthy subjects were studied. RESULTS: Most QOL scores were highly reliable. There was a significant impairment in eight of nine QOL dimensions in patients with perennial allergic rhinitis in comparison with healthy subjects. CONCLUSIONS: The SF-36 Health Status Questionnaire allows discrimination between patients with perennial allergic rhinitis and healthy subjects.
Citation: Paterson C, Measuring outcomes in primary care: a patient generated measure, MYMOP, compared with the SF-36 health survey., BMJ 312: 7037, 1016-20, Apr 20, 1996.
OBJECTIVE--To assess the sensitivity to within person change over time of an outcome measure for practitioners in primary care that is applicable to a wide range of illness. DESIGN--Comparison of a new patient generated instrument, the measure yourself medical outcome profile (MYMOP), with the SF-36 health profile and a five point change score; all scales were completed during the consultation with' practitioners and repeated after four weeks. 103 patients were followed up for 16 weeks and their results charted; seven practitioners were interviewed. SETTING--Established practice of the four NHS general practitioners and four of the private complementary practitioners working in one medical centre. SUBJECTS--Systematic sample of 218 patients from general practice and all 47 patients of complementary practitioners; patients had had symptoms for more than seven days. OUTCOME MEASURES--Standardised response mean and index of responsiveness; view of practitioners. RESULTS--The index of responsiveness, relating to the minimal clinically important difference, was high for MYMOP: 1.4 for the first symptom, 1.33 for activity, and 0.85 for the profile compared with < 0.45 for SF-36. MYMOP's validity was supported by significant correlation between the change score and the change in the MYMOP score and the ability of this instrument to detect more improvement in acute than in chronic conditions. Practitioners found that MYMOP was practical and applicable to all patients with symptoms and that its use increased their awareness of patients' priorities. CONCLUSION--MYMOP shows promise as an outcome measure for primary care and for complementary treatment.It is more sensitive to change than the SF-36 and has the added bonus of improving patient-practitioner communication.
Citation: Rector TS, Ormaza SM, Kubo SH, Health status of heart transplant recipients versus patients awaiting heart transplantation: a preliminary evaluation of the SF-36 questionnaire., J Heart Lung Transplant 12: 6 Pt 1, 983-6, Nov-Dec, 1993.
Measures of the effects of health care on patients' lives are being requested to evaluate heart transplantation programs. A relatively short, 36-item, questionnaire (SF-36) designed to measure health status is being evaluated as an outcome measure for a variety of conditions. The SF-36 was sent to all adults awaiting heart transplantation (n = 48) and heart transplant recipients (n = 177) at the University of Minnesota as a pilot study of the SF-36 applied to heart transplantation. Response rates were 88% and 81%, respectively. Heart transplant recipients had significantly (p < 0.0001) better scores for general health perceptions (70 +/- 21 versus 33 +/- 21), vitality (62 +/- 19 versus 39 +/- 2), physical function (71 +/- 22 versus 36 +/- 24), ability to perform roles without physical limitations (62 +/- 41 versus 27 +/- 35), and social function (85 +/- 18 versus 63 +/- 31) compared with patients awaiting heart transplantation. Mental function and ability to perform roles without emotional problems were good in both groups and not significantly different. Mean SF-36 scores for the heart transplant recipients were uniformly not as high as scores for a historical group with only minor medical problems. These preliminary data suggest that the SF-36 is sensitive to the effects of heart transplantation. Additional studies of the SF-36 as an outcome measure for heart transplantation are warranted and should include methods to control for extraneous variability and to provide unbiased data collection.
Citation: Sullivan M, Karlsson J, Ware JE Jr, The Swedish SF-36 Health Survey--I. Evaluation of data quality, scaling assumptions, reliability and construct validity across general populations in Sweden., Soc Sci Med 41: 10, 1349-58, Nov, 1995.
We document the applicability of the SF-36 Health Survey, which was translated into Swedish using methods later adopted by the International Quality of Life Assessment (IQOLA) Project procedures. To test its appropriateness for use in Sweden, it was administered through mail-out/mail-back questionnaires in seven general population studies with an average response rate of 68%. The 8930 respondents varied by gender (48.2% men), age (range 15-93 years, mean age 42.7), marital status, education, socio-economic status, and geographical area. Psychometric methods used in the evaluation of the SF-36 in the U.S. were replicated. Over 90% of respondents had complete items for each of the eight SF-36 scales, although more missing data were observed for subjects 75 years and over. Scale scores could be computed for the vast majority of respondents (95% and over); slightly fewer in the oldest subgroup. Item-internal consistency was consistently high across socio-demographic subgroups and the eight scales. Most reliability estimates exceeded the 0.80 level. The highest reliability was observed for the Bodily Pain Scale where all subgroups met the 0.90 level recommended for individual comparisons; coefficients at or above 0.90 were also observed in most subgroups for the Physical Functioning Scale. Tests of scaling assumptions including hypothesized item groupings, which reflect the construct validity of scales, were consistently favorable across subgroups, although lower rates were noted in the oldest age group. In conclusion, these studies have yielded empirical evidence supporting the feasibility of a non-English language reproduction of the SF-36 Health Survey.The Swedish SF-36 is ready for further evaluation.
Citation: Julious SA, George S, Campbell MJ, Sample sizes for studies using the short form 36 (SF-36)., J Epidemiol Community Health 49: 6, 642-4, Dec, 1995.
Citation: Leplege A, Mesbah M, Marquis P, [Preliminary analysis of the psychometric properties of the French version of an international questionnaire measuring the quality of life: the MOS SF-36 (version 1.1)], Rev Epidemiol Sante Publique 43: 4, 371-9, , 1995.
The International Quality of Life Assessment (IQOLA) Project is a 4 year project initiated in 1991 to translate and adapt the Medical Outcome Study Short Form 36 item Health Survey (SF-36) in at least 15 countries. This paper reports on the preliminary psychometric assessment of the SF-36 in French (version 1.1). The validation data come from two studies: a phase IV study of 121 patients with arthritis and a phase IV study of 159 patients with angina. In both cases, the patients were surveyed using the SF-36 and a disease specific module. The main objective of this analysis was to determine how well the scaling assumptions (summated rating or Likert type scaling construction) of the SF-36 were satisfied. Item convergent validity was supported as items-scale correlation range from 0.47-0.87. Item discriminant validity was supported as all items were more correlated with their hypothesised scales than with scales measuring other concepts. Our data support the assumption that the items measuring the same concept had approximately equal variance. Items in a given scale contained about the same proportion of information about the concept being measured, as most items of any given dimension had approximately the same correlation with that dimension. The Cronbach alpha coefficient ranged between 0.79 and 0.95. The correlation between two scales was less than the reliability coefficient for those scales, and these correlations adjusted for attenuation were less than 1. These preliminary results are encouraging. They indicate that the items are linearly related to the underlying concept being measured.(ABSTRACT TRUNCATED AT 250 WORDS)
Citation: Perneger TV, Leplege A, Etter JF, Rougemont A, Validation of a French-language version of the MOS 36-Item Short Form Health Survey (SF-36) in young healthy adults., J Clin Epidemiol 48: 8, 1051-60, Aug, 1995.
The MOS 36-Item Short Form Health Survey (SF-36) is designed to measure 8 dimensions of health in clinical and general population settings. The main aim of this paper was to examine the reliability and validity of this instrument in young adults. A secondary aim was to document the results of a rapid translation procedure of the instrument, to be compared later to the more thorough official French adaptation. The translated survey was answered in 1992 by 1007 residents of Geneva, Switzerland, 18-44 years old, identified from health insurance rolls (82% response rate). Completion rate for all 8 dimensions of health was 95.5%. The instrument demonstrated excellent covergent ("100%") and discriminant (98%) validity against pre-set criteria. Interval scaling of responses could be verified in some, but not all, items. Cronbach alpha (reliability) coefficients ranged from 0.76 to 0.92. Factorial analysis yielded 2 principal components, corresponding to mental and physical health. Thirteen of 16 correlations between health dimensions and principal components were within a pre-established range. Validation by independent clinical variables was also, with few exceptions, consistent with theory. Thus the SF-36 retained excellent psychometric properties even when used in a generally very healthy group. The careful but rapid translation procedure used in this study may be an effective alternative to full-scale cultural adaptations when resources are limited.
Citation: Bousquet J, Duchateau J, Pignat JC, Fayol C, Marquis P, Mariz S, Ware JE, Valentin B, Burtin B, Improvement of quality of life by treatment with cetirizine in patients with perennial allergic rhinitis as determined by a French version of the SF-36 questionnaire., J Allergy Clin Immunol 98: 2, 309-16, Aug, 1996.
BACKGROUND AND AIM: Perennial allergic rhinitis impairs social life, but it is not known whether quality of life may be improved when patients are treated with an H1-blocker. A randomized, double-blind, placebo-controlled study was carried out with cetirizine to assess the effect of this drug on quality of life. METHODS: Two hundred seventy-four patients with perennial allergic rhinitis were tested. Quality of life was measured by using the Medical Outcome Study Short-Form Health Survey (SF-36) questionnaire. After a 2-week run-in period, cetirizine, 10 mg once daily, (136 patients) or placebo (138 patients) was given for the next 6 weeks. The SF-36 questionnaire was administered after the run-in period (at the start of treatment) and after 1 and 6 weeks of treatment. Symptom-medication scores were measured daily during the study. RESULTS: After the run-in period (baseline), there were no significant differences between the cetirizine and placebo groups in terms of symptoms or quality-of-life scores. After 6 weeks of treatment, percentage of days without rhinitis or with only mild rhinitis symptoms was significantly greater in the cetirizine group in comparison with the placebo group (p < 0.0001, Mann-Whitney U test). All of the nine quality-of-life dimensions were significantly improved (from p = 0.01 to p < 0.0001, Mann-Whitney U test) after 1 and 6 weeks of cetirizine treatment compared with placebo. There was no improvement in the placebo group. CONCLUSIONS: This study is the first to demonstrate that an H1-blocker, cetirizine, can improve quality of life for patients with perennial allergic rhinitis.
Citation: Ware JE Jr, Kosinski M, Bayliss MS, McHorney CA, Rogers WH, Raczek A, Comparison of methods for the scoring and statistical analysis of SF-36 health profile and summary measures: summary of results from the Medical Outcomes Study., Med Care 33: 4 Suppl, AS264-79, Apr, 1995.
Physical component summary (PCS) and mental component summary (MCS) measures make it possible to reduce the number of statistical comparisons and thereby the role of chance in testing hypotheses about health outcomes. To test their usefulness relative to a profile of eight scores, results were compared across 16 tests involving patients (N = 1,440) participating in the Medical Outcomes Study. Comparisons were made between groups known to differ at a point in time or to change over time in terms of age, diagnosis, severity of disease, comorbid conditions, acute symptoms, self-reported changes in health, and recovery from clinical depression. The relative validity (RV) of each measure was estimated by a comparison of statistical results with those for the best scales in the same tests. Differences in RV among scales from the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) were consistent with those in previous studies. One or both of the summary measures were significant for 14 of 15 differences detected in multivariate analyses of profiles and detected differences missed by the profile in one test. Relative validity coefficients ranged from .20 to .94 (median, .79) for PCS in tests involving physical criteria and from .93 to 1.45 (median, 1.02) for MCS in tests involving mental criteria. The MCS was superior to the best SF-36 scale in three of four tests involving mental health. Results suggest that the two summary measures may be useful in most studies and that their empiric validity, relative to the best SF-36 scale, will depend on the application. Surveys offering the option of analyzing both a profile and psychometrically based summary measures have an advantage over those that do not.
Citation: Hill S, Harries U, Popay J, Is the short form 36 (SF-36) suitable for routine health outcomes assessment in health care for older people? Evidence from preliminary work in community based health services in England., J Epidemiol Community Health 50: 1, 94-8, Feb, 1996.
STUDY OBJECTIVE: To examine the short form 36 (SF-36) health status measure when used to assess older people's views of the outcome of community based health care. DESIGN: Completion of a structured questionnaire, before and after intervention alongside in-depth interviews with a subsample of the interviewees. SETTING: Community based continence and mental health services in two health authorities in the North West Health Region. PATIENTS: Forty seven older people newly referred to mental health services or continence services between December 1992 and April 1993 participated. MAIN RESULTS: The SF-36 showed minimal change over time for both patient groups. The more detailed in-depth interviews showed that people experienced positive changes and derived value from contact with services in a number of important ways. For many reasons these benefits were not reflected in their SF-36 scores. CONCLUSIONS: The SF-36 is not likely to be the "measure of choice" for this type of evaluation, particularly where it involves older patient groups who have high levels of comorbidity. The content of the SF-36 and its lack of detail for individual assessment of change means it masks rather than illuminates patients' views of outcome.
Citation: McHorney CA, Kosinski M, Ware JE Jr, Comparisons of the costs and quality of norms for the SF-36 health survey collected by mail versus telephone interview: results from a national survey., Med Care 32: 6, 551-67, Jun, 1994.
Many health status surveys have been designed for mail, telephone, or in-person administration. However, with rare exception, investigators have not studied the effect the survey mode of administration has on the way respondents assess their health and other important parameters (such as response rates, nonresponse bias, and data quality), which can affect the generalizability of results. Using a national sampling frame of noninstitutionalized adults from the General Social Survey, we randomly assigned adults to a mail survey ("80%") or a computer-assisted telephone survey ("20%"). The surveys were designed to provide national norms for the SF-36 Health Survey. Total data collection costs per case for the telephone survey ($47.86) were 77% higher than that for the mail survey ($27.07). A significantly higher response rate was achieved among respondents randomly assigned to the mail (79.2%) than telephone survey (68.9%). Nonresponse bias was evident in both modes but, with the exception of age, was not differential between modes. The rate of missing responses was higher for mail than telephone respondents (1.59 vs. 0.49 missing items). Health ratings based on the SF-36 scales were less favorable, and reports of chronic conditions were more frequent, for mail than telephone respondents. Results are discussed in light of the trade-offs involved in choosing a survey methodology for health status assessment applications. Norms for mail and telephone versions of the SF-36 survey are provided for use in interpreting individual and group scores.
Citation: Bullinger M, German translation and psychometric testing of the SF-36 Health Survey: preliminary results from the IQOLA Project. International Quality of Life Assessment., Soc Sci Med 41: 10, 1359-66, Nov, 1995.
International translation and psychometric testing of generic health outcome measures is increasingly in demand. Following the methodology developed by the International Quality of Life Assessment group (IQOLA) we report the German work with the SF-36 Health Survey. The form was translated using a forward-backward method with accompanying translation quality ratings and pilot tested in terms of translation clarity and applicability. Psychometric evaluation included Thurstone's test of ordinality and equidistance of response choices in 48 subjects as well as testing of reliability, validity, responsiveness and discriminative power of the form in crossectional studies of two samples of healthy persons and longitudinal studies of two samples of pain patients totalling 940 respondents. Quality ratings of translations were favorable, suggesting a high quality of both forward and backward translations. In the pilot study, the form was well understood and easily administered, suggesting high clarity and applicability. Thurstone's test revealed ordinality (in over 90% of the cases) and rough equidistance of response choices also as compared to the American original. On item and scale level, missing data were low and descriptive statistics indicated acceptable distribution characteristics. In all samples studied, discriminative item validity was high (over 90% scaling successes) and Cronbach's alpha reliabilities were above the 0.70 criterion with exception of one scale. Furthermore convergent validity, responsiveness to treatment and discriminative power in distinguishing between healthy and ill respondents was present. The preliminary results suggest that the SF-36 Health Survey in its German form may be a valuable tool in epidemiological and clinical studies. However further work as concerns responsiveness and population based norms is necessary.
Citation: Hawker G, Melfi C, Paul J, Green R, Bombardier C, Comparison of a generic (SF-36) and a disease specific (WOMAC) (Western Ontario and McMaster Universities Osteoarthritis Index) instrument in the measurement of outcomes after knee replacement surgery., J Rheumatol 22: 6, 1193-6, Jun, 1995.
OBJECTIVE. The discriminant validity of a generic, health related quality of life (HRQL) measure, the SF-36, was compared with that of a disease specific HRQL measure, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in patients aged 67-99 years who had undergone knee replacement surgery 2 to 7 years previously. METHODS. A stratified random sample of 1750 Medicare beneficiaries was surveyed and 1193 usable responses were obtained (after adjustment for ineligible, incapacitated, and deceased individuals). Discriminant validity of scale scores common to both instruments (pain, physical functioning, and overall score) were compared. RESULTS. Examination of discriminant validity, using Spearman correlations, showed that the WOMAC discriminates better among individuals with knee problems, while the SF-36 discriminates better among individuals with varying levels of self reported general health status and comorbidities. CONCLUSION. These scales measure 2 distinct but important aspects of patients' health. These results support inclusion of both a generic and a disease specific HRQL measure in cross sectional studies.
Citation: Jenkinson C, Peto V, Coulter A, Measuring change over time: a comparison of results from a global single item of health status and the multi-dimensional SF-36 health status survey questionnaire in patients presenting with menorrhagia., Qual Life Res 3: 5, 317-21, Oct, 1994.
This paper compares the sensitivity to change of a multi-item, multi-dimensional health status measure with a single global health status question, in the assessment of treatment for menorrhagia. A cohort study of patients recruited by general practitioners, was carried out, with a follow up at eighteen months. Questionnaires were administered postally at base-line and follow up. General practices in Berkshire, Buckinghamshire, Northamptonshire and Oxfordshire supplied three hundred and nine women who reported heavy menstrual bleeding, and received either drug treatment alone or both drug and surgical treatment (endometrial resection or hysterectomy) during the eighteen months between the two administrations of the questionnaires. A single global question was given to patients asking them to rate their overall health status as 'excellent', 'very good', 'good', 'fair' or 'poor'. The eight dimensions of the SF-36 health survey questionnaire were also given to patients to complete. The dimensions of the SF-36 indicated only small levels of improvement for patients who received drug treatment. However, on many dimensions of the SF-36, a moderate to large improvement was detected for the surgical group. However, small changes were reported in overall health status, as indicated by the single global question, for both groups. Single item measures of health status may not provide a sufficiently accurate indication of health status to be appropriate for use in longitudinal studies.
Citation: Jette DU, Downing J, Health status of individuals entering a cardiac rehabilitation program as measured by the medical outcomes study 36-item short-form survey (SF-36)., Phys Ther 74: 6, 521-7, Jun, 1994.
BACKGROUND AND PURPOSE. The goal of health care for individuals with chronic disease is the improvement of function and well-being. Although the individual's perception of his or her quality of life may be the best indicator of achievement of this goal, measurement of self-perceived quality of life, or health status, is not a routine component of evaluation. The purposes of this article are to describe the health status of individuals upon entry into a cardiac rehabilitation program and to demonstrate the use of a comprehensive, generic health status measure in this group. SUBJECTS. The subjects of this study were 789 men and women enrolled in one of 13 cardiac rehabilitation programs in the state of Massachusetts. METHODS. As part of a large database, subjects completed a 36-item generic questionnaire, Short Form 36 (SF-36), that examines eight health concepts. Scores range from 0% to "100%"; a higher score is consistent with better health status. Results. Mean uncontrolled scores ranged from 26.6 to 70.8. Mean scores adjusted for sex, age, and education ranged from 27.1 to 70.9. In light of previously published data using a similar 20-item scale, our results show that cardiac disease is associated with reductions in health-related quality of life. CONCLUSION AND DISCUSSION. Health status measurement provides information that can supplement the usual measures of impairment in patients with cardiovascular disease. The findings of this study contribute to the understanding of health status of individuals who enroll in cardiac rehabilitation programs.The health status instrument used in this study has potential as a useful, practical measurement tool for use in the clinical setting.
Citation: Haley SM, McHorney CA, Ware JE Jr, Evaluation of the MOS SF-36 physical functioning scale (PF-10): I. Unidimensionality and reproducibility of the Rasch item scale., J Clin Epidemiol 47: 6, 671-84, Jun, 1994.
Indexes developed to measure physical functioning as an essential component of general health status are often based on sets of hierarchically-structured items intended to represent a broad underlying concept. Rasch Item Response Theory (IRT) provides a methodology to examine the hierarchical structure, unidimensionality, and reproducibility of item positions (calibrations) along a scale. Data gathered on the 10-item Physical Functioning Scale (PF-10) from a large sample of Medical Outcomes Study patients (N = 3445) were used to examine the hierarchical order, unidimensionality, and reproducibility of item calibrations. Rasch-IRT analyses generated an empirical item hierarchy, confirmed the unidimensionality of the PF-10 for most patients, and established the reproducibility of item calibrations across patient populations and repeated tests. These findings support the content validity of the PF-10 as a measure of physical functioning and suggest that valid Rasch-IRT summary scores could be generated as an alternative to the current Likert summative scores. Unidimensionality and reproducibility of the item scale are essential prerequisites for the development of Rasch-based person measures of physical functioning that can be used across populations and over repeated tests.
Citation: Baker DM, Turnbull NB, Pearson JC, Makin GS, How successful is varicose vein surgery? A patient outcome study following varicose vein surgery using the SF-36 Health Assessment Questionnaire., Eur J Vasc Endovasc Surg 9: 3, 299-304, Apr, 1995.
OBJECTIVE: Assessment of outcome after varicose vein surgery. DESIGN: Prospective study using the Health Assessment Questionnaire (SF36) which considers different aspects of overall health. SETTING: University Hospital and Community. MATERIALS: 150 patients undergoing varicose vein surgery. CHIEF OUTCOME MEASURES: SF36 questionnaires were sent pre-operatively and at 1 and 6 months post surgery. MAIN RESULTS: Eighty-nine (59%) patients answered all three questionnaires. Pre-operatively their overall health was similar to that of the general population. The "cost" to the patient of the operation was demonstrated by an increased pain and reduced role function at 1 month post-operation (p < 0.01). By 6 months post-operation, when compared with preoperative values, all dimensions except social function and health perception were improved (p < 0.01). Overall symptoms improved (p < 0.01) by 1 month and were further improved at 6 months. CONCLUSIONS: The general good health of varicose vein patients may justify the low priority given to their treatment, but the improvement in symptoms and general health that relatively simple surgery provides should ensure its continued provision as a health care service.
Citation: Johnson JA, Nowatzki TE, Coons SJ, Health-related quality of life of diabetic Pima Indians., Med Care 34: 2, 97-102, Feb, 1996.
This study was designed to measure the health-related quality of life of a sample of diabetic Pima Indians. Health status questionnaires were administered to 54 diabetic Pima Indians attending an out-patient pharmacy in southern Arizona. Health-related quality of life was assessed using the SF-36 Health Survey. Internal consistencies of the eight multi-item scales of the SF-36 were estimated. Nonparametric analyses were performed to determine relationships between mean SF-36 scale scores and various clinical and demographic variables. Favorable internal consistencies for the multi-item scales were observed, with alpha coefficients ranging from 0.63 to 0.91. SF-36 scale scores were not influenced by sex or education level. Age was significantly associated with four of the eight dimensions. Indicators of glycemic control were not significantly associated with any SF-36 multi-item scale scores. Subjects with more comorbid chronic conditions had significantly lower SF-36 scores. If the goal of maximizing health status of American Indians is to be reached, health-related quality-of-life assessment should be used as a means to monitor progress toward that goal. Further evaluation of the SF-36 or other health status/quality-of-life instruments in this population should be undertaken.
Citation: Weinberger M, Oddone EZ, Samsa GP, Landsman PB, Are health-related quality-of-life measures affected by the mode of administration?, J Clin Epidemiol 49: 2, 135-40, Feb, 1996.
While measures of health-related quality of life (HRQOL) are increasingly being used as outcomes in clinical trials, it is unknown whether HRQOL assessments are influenced by the method of administration. We compared telephone, face-to-face, and self-administration of a commonly-used HRQOL measure, the SF-36. Veterans (N = 172) receiving care in the General Medicine Clinic were randomized into groups differing only in order of administration. All patients were asked to complete the SF-36 three times over a 4-week period. The SF-36 demonstrated high internal consistency, regardless of mode of administration, but showed large variation over short intervals. This variation may: (1) increase dramatically sample size requirements to detect between-group differences in randomized trials and (2) reduce the SF-36's usefulness for clinicians wishing to follow individual patients over time.
Citation: Viramontes JL, O'Brien B, Relationship between symptoms and health-related quality of life in chronic lung disease., J Gen Intern Med 9: 1, 46-8, Jan, 1994.
The authors studied the relationship between patient self-reported symptoms and responses to a general measure of health-related quality of life [Short Form 36 (SF-36)] for 102 patients who had chronic lung disease [forced expiratory volume in one second (FEV1) < 70%]. The primary diagnoses were chronic bronchitis, emphysema, and asthma; the mean age was 62 years, and 46% were women. Based upon Medical Research Council (MRC) symptom scores, the patients' disease severity was classified as mild (21%), moderate (22%), or severe (57%). The SF-36 scores differed significantly between disease severity groups in domains of health perception, physical functioning, physical role, and energy. The SF-36 physical functioning and Oxygen Cost Diagram scores correlated well (r = 0.78). The authors conclude that SF-36 is a useful and valid measure of general health status in patients with chronic lung disorders.
Citation: Ziebland S, The short form 36 health status questionnaire: clues from the Oxford region's normative data about its usefulness in measuring health gain in population surveys., J Epidemiol Community Health 49: 1, 102-5, Feb, 1995.
OBJECTIVES--To determine the potential of the short form 36 health status questionnaire (SF-36) for indicating changes in the health status of a general population by examining the recently published normative data. DESIGN--The sensitivity of the SF-36 was tested through hypothesising two dramatic changes in health status whereby (i) the scores of people in social class V are improved to the level of social class I, and (ii) the scores of men and women aged 55 to 64 are altered to the level of current 45 to 54 year olds. The size of the effect measured by the SF-36 was considered. RESULTS--Small to moderate effects were evident when SF-36 mean scores for social class V were increased to the level of social class I, and primarily negligible effects were apparent on all domains but physical function for the postulated "10 years of age" improvement. CONCLUSION--The SF-36 may be a useful measure for detecting changes in health status in homogenous treatment groups, but the variation in responses in a general population make it an inadequate tool for assessing the diffuse impact of health interventions directed at the whole community.
Citation: Gliklich RE, Hilinski JM, Longitudinal sensitivity of generic and specific health measures in chronic sinusitis., Qual Life Res 4: 1, 27-32, Feb, 1995.
The utility of reliable health measures for longitudinal studies in chronic sinusitis depends on their ability to detect clinically relevant change. Sixty-three patients with chronic sinusitis were evaluated before and three months after ethmoid sinus surgery using the Chronic Sinusitis Survey (CSS) and the generic Short-Form 36-Item Health Survey (SF-36). Statistically significant improvement was found for several SF-36 subscales including physical functioning, role functioning-physical, bodily pain, vitality and all CSS subscales. However, the differences between the instruments in longitudinal sensitivity to change as measured by standardized response means (SRM) and effect sizes (ES) were large. For the SF-36, sensitivity to change ranged from minimal to small (SRM: 0.01-0.43; ES: 0.01-0.52) with bodily pain and role functioning-physical scores most sensitive. For the CSS, sensitivity to change ranged from moderate to large (SRM: 0.56-0.82; ES: 0.48-1.12) with symptom-based and total index scores most sensitive. Despite this, the SF-36 yielded useful information concerning the relative burden of chronic sinusitis and failure of these patients to achieve normal levels of general health 3 months after sinus surgery. We conclude that the disease-specific CSS was more sensitive to change than the SF-36 survey in patients following ethmoid sinus surgery.
Citation: Stucki G, Liang MH, Phillips C, Katz JN, The Short Form-36 is preferable to the SIP as a generic health status measure in patients undergoing elective total hip arthroplasty., Arthritis Care Res 8: 3, 174-81, Sep, 1995.
OBJECTIVE. To assess the comparative usefulness of the Short Form-36 (SF-36) and the Sickness Impact Profile, (SIP) as generic health status measures in total hip arthroplasty. METHODS. Analysis of preoperative and 3-month data of 54 consecutive patients undergoing total hip replacement for osteoarthritis or rheumatoid arthritis. Instruments were mailed to patients preoperatively and 3 months postoperatively. RESULTS. In 10 of the 12 SIP subscales, but just 1 of the 8 SF-36 subscales, more than 40% of the patients had scores of zero. On a 100-point scale, the median global SIP was 12 (range 0-40) whereas the median global SF-36 was 50 (range 10-85). This indicates that many items of the SIP were not germane to patients undergoing joint arthroplasty. The global and, particularly, the physical dimensions of the SF-36 were more responsive than their SIP counterparts, as measured both by the standardized response mean (1.26 and 0.88, respectively) and the correlation with self-perceived improvement in quality of life (r = 0.37 and 0.26, respectively). The SF-36, but not the SIP, discriminated between patients with relatively good physical performance at 3 months with respect to their ability to work, to play sports, or to garden. CONCLUSION. The SF-36 is briefer, more relevant, and more responsive than the SIP and is preferable as a generic health status measure in patients undergoing elective hip arthroplasty. The SF-36 should be tested in other populations as well as other conditions to determine whether it is a superior generic health status instrument for evaluative research in orthopedic surgery.
Citation: Heiligenstein JH, Ware JE Jr, Beusterien KM, Roback PJ, Andrejasich C, Tollefson GD, Acute effects of fluoxetine versus placebo on functional health and well-being in late-life depression., Int Psychogeriatr 7 Suppl: 125-37, , 1995.
In a randomized 6-week trial comparing fluoxetine with placebo, the Medical Outcomes Study 36-Item Short-Form Health Status Survey (SF-36) scales were used to measure the effects of treatment on functional health and well-being among elderly (age > or = 60 years) out-patients with major depression. In the fluoxetine and placebo groups, 261 and 271 patients, respectively, completed the SF-36 before treatment and at Weeks 3 and 6. Compared with national norms for individuals over age 60, study patients before treatment exhibited baseline decrements on the following SF-36 scales: mental health, role limitations due to emotional problems, social functioning, vitality, role limitations due to physical problems, and bodily pain. Analyses of SF-36 changed scores from baseline to Week 6 revealed that the fluoxetine group improved more than the placebo group across all scales. Differences in changes of scores between groups were significant (p < .05), favoring the fluoxetine group for the scales of mental health, role limitations due to emotional problems, physical functioning, and bodily pain. Improvements observed in the fluoxetine group were both clinically and socially significant.
Citation: Walker V, Streiner DL, Novosel S, Rocchi A, Levine MA, Dean DM, Health-related quality of life in patients with major depression who are treated with moclobemide., J Clin Psychopharmacol 15: 4 Suppl 2, 60S-67S, Aug, 1995.
A total of 651 depressed patients completed self-administered health-related quality-of-life (HRQOL) questionnaires during treatment with moclobemide in order to evaluate whether general and psychopathology-specific HRQOL questionnaires could detect changes in depressed patients receiving treatment. Patients were treated with moclobemide on an out-patient basis over an 8-week period; questionnaires were completed at weeks 0, 2, 4, and 8. At each assessment, patients completed one of two HRQOL questionnaires: namely, the General Health Questionnaire (GHQ), a psychopathology-specific HRQOL questionnaire, or the Short-Form 36 (SF-36), a general HRQOL instrument. Physicians were randomized to one of the two HRQOL questionnaires for all of their patients. Because the French version of the SF-36 was not available in the public domain, the patients of all Francophone physicians completed the GHQ, whereas the patients enrolled by Anglophone physicians completed either the SF-36 or the GHQ. The GHQ provides an overall score that measures the emotional dimensions of HRQOL, whereas the SF-36 provides scores in the following eight domains: physical functioning (PF), physical role functioning (PRF), emotional role functioning (ERF), social functioning (SF), bodily pain (BP), mental health (MH), vitality (VT), and general health perceptions (GHP). The GHQ and seven domains of the SF-36 detected a statistically significant linear trend (improvement) over time (p < 0.05). The change in the BP domain of the SF-36 was not statistically significant (p = 0.29).(ABSTRACT TRUNCATED AT 250 WORDS)
Citation: Solomon GD, Skobieranda FG, Genzen JR, Quality of life assessment among migraine patients treated with sumatriptan [see comments], Headache 35: 8, 449-54, Sep, 1995.
PURPOSE--Quality of life evaluations can enhance traditional measures of therapeutic efficacy. The purpose of our study was to evaluate the impact of sumatriptan on the quality of life of patients with migraine headaches. PATIENTS AND METHODS--Migraine patients who were given a prescription for sumatriptan completed an SF-36 questionnaire and a nine-item pain questionnaire. Six to 9 months later, patients were mailed another copy of the SF-36 and the nine-item pain questionnaire. We compared the pretreatment and posttreatment scores for the SF-36 and for each question of the nine-item pain questionnaire. RESULTS--The pretreatment SF-36 was completed by 255 patients. The pretreatment pain questionnaire was completed by 86 of these patients. Follow-up questionnaires were returned by 147 patients (58%). Three of the eight SF-36 scales: role functioning--physical, bodily pain, and social functioning showed significant (P < 0.05) improvement with treatment. On the nine-item pain-specific questionnaire, three items--pain interference with normal work, ability to walk or move about, and enjoyment of life showed statistically significant (P < 0.05) improvement after sumatriptan treatment. CONCLUSIONS--Sumatriptan caused a significant improvement in the quality of life of patients with very severe migraine. This improvement was measurable by both the general quality of life instrument and the pain-specific questionnaire.
Citation: Johnson PA, Goldman L, Orav EJ, Garcia T, Pearson SD, Lee TH, Comparison of the Medical Outcomes Study Short-Form 36-Item Health Survey in black patients and white patients with acute chest pain., Med Care 33: 2, 145-60, Feb, 1995.
Few data are available regarding the performance of the Medical Outcomes Study (MOS) Short-Form 36-Item Health Survey (SF-36) in black patients. In this article, the reliability and validity of the MOS SF-36 is compared in a population of black patients and white patients with acute chest pain. The MOS SF-36 was administered to 1,160 patients (31% black) who presented to the emergency department of an urban teaching hospital with acute chest pain from October 1990 to May 1992. In unadjusted analyses, black patients had significantly lower scores compared with white patients for several dimensions of the SF-36. Correlations among the eight subscales were similar, and the internal consistency of each of the eight subscales was excellent for both groups (Cronbach's coefficient alpha range .64 to .93). Each subscale had similar clinical and nonclinical correlates in black patients and white patients. In multivariate models, race was not a significant independent correlate of any of the eight subscales. Thus, the MOS SF-36 had similar reliability and validity in this population of black patients and white patients with acute chest pain who presented to an urban teaching hospital. If these findings are confirmed in other populations, they suggest that results from the MOS SF-36 may be interpreted similarly in black patients and white patients, after adjusting for clinical and sociodemographic data. Whether these findings are generalizable to other conditions and less acute settings requires further investigation.
Citation: Fielder H, Denholm SW, Lyons RA, Fielder CP, Measurement of health status in patients with vertigo., Clin Otolaryngol 21: 2, 124-6, Apr, 1996.
In order to assess how much disability is caused by vertigo, health status scores of patients referred with dizziness or vertigo were compared with local population normative data and with the severity of illness, measured by a disease-specific questionnaire. The questionnaires were administered by post to patients awaiting an ENT out-patient appointment. There was a strong correlation (P = 0.001) between the eight dimensions of the SF-36 (Mos 36 item short-form health survey) and disease severity, measured by the Dizziness Handicap Inventory questionnaire. Compared with the general population, vertigo sufferers had significant role limitation due to physical problems and social functioning (men) and physical problems and vitality (women). General health status is significantly affected by both the presence and severity of vertigo and the SF-36 may prove useful in assessing outcomes.
Citation: Reuben DB, Valle LA, Hays RD, Siu AL, Measuring physical function in community-dwelling older persons: a comparison of self-administered, interviewer-administered, and performance-based measures., J Am Geriatr Soc 43: 1, 17-23, Jan, 1995.
PURPOSE: To compare two self-administered, one interviewer-administered, and one performance-based measure of physical function in community-based older persons. METHODS: Eighty-three subjects were recruited from meal sites, senior recreation centers, and senior housing units for a comprehensive geriatric assessment program. At the time of screening, study participants self-administered the Functional Status Questionnaire (FSQ) and were administered the Katz Activities of Daily Living (ADL) and the Older Americans Resources and Services Instrumental Activities of Daily Living (OARS-IADL) instruments by interview. Participants also completed the Physical Performance Test (PPT) and were given the Medical Outcomes Study SF-36 to self-administer on site or at home and return by mail. RESULTS: All 83 subjects completed FSQ, Katz ADL, OARS-IADL, and PPT; 72 returned SF-36 forms. Correlations between the two self-administered physical function measures (FSQ and SF-36) were higher than between self-administered and interviewer-assessed (ADL and OARS-IADL) or performance-based (PPT) measures. When assessed for construct validity, the self-administered, OARS, and PPT measures had comparable correlations with role limitations as a result of physical health problems, but relationships between physical functional status measures and other SF-36 measures of health were inconsistent. CONCLUSION: The relationships between commonly used self-administered, interviewer-administered, and performance-based measures of physical function were inconsistent and weak, suggesting that these instruments are not measuring the same construct.
Citation: Ware JE Jr, Keller SD, Gandek B, Brazier JE, Sullivan M, Evaluating translations of health status questionnaires. Methods from the IQOLA project. International Quality of Life Assessment., Int J Technol Assess Health Care 11: 3, 525-51, Summer, 1995.
There is growing demand for translations of health status questionnaires for use in multinational drug therapy studies and for population comparisons of health statistics. The International Quality of Life Assessment (IQOLA) Project is conducting a three-stage research program to determine the feasibility of translating the SF-36 Health Survey, widely used in English-speaking countries, into other languages. In stage 1, the conceptual equivalence and acceptability of translated questionnaires are evaluated and improved using qualitative and quantitative methods. In stage 2, assumptions underlying the construction and scoring of questionnaire scales are tested empirically. In stage 3, the equivalence of the interpretation of questionnaire scores across countries is tested using methods that closely approximate their intended use, and empirical results are compared. Data analyses from Sweden and the United Kingdom, as well as other research cited, support the feasibility of cross-cultural health measurement using the SF-36.
Citation: Lee PP, Whitcup SM, Hays RD, Spritzer K, Javitt J, The relationship between visual acuity and functioning and well-being among diabetics., Qual Life Res 4: 4, 319-23, Aug, 1995.
Given the enormous recent interest in functional capabilities related to vision, the goal of this study was to examine the relationship of standard clinical measures of vision (e.g. Snellen acuity) to functioning and well-being. The association between Snellen visual acuity, Amsler grid distortion and presence of diabetic retinopathy with self-reported functioning and well-being (SF-36) were examined in a sample of 327 diabetics from the Medical Outcomes Study (MOS). There was little or no correlation between Snellen visual acuity, Amsler grid distortion or diabetic retinopathy and functioning and well-being (i.e. SF-36 scales). Maximum product-moment correlation was 0.15 with worst eye visual acuity, 0.13 with best eye visual acuity, 0.08 with presence of retinopathy, and 0.10 with Amsler grid distortion. Analysis of variance revealed that visual acuity (both best and worst eye) was statistically related only to the physical function scale; no other exam measure was related to any other SF-36 scale score. Snellen visual acuity, Amsler distortion and diabetic retinopathy correlate weakly with patient self-reported functioning and well-being. Thus, the information provided by functioning and well-being measures is complementary to that of standard clinical measures of visual ability.
Citation: Garratt AM, Ruta DA, Russell I, Macleod K, Brunt P, McKinlay A, Mowat A, Sinclair T, Developing a condition-specific measure of health for patients with dyspepsia and ulcer-related symptoms., J Clin Epidemiol 49: 5, 565-71, May, 1996.
A patient-administered instrument for dyspepsia and symptoms suggestive of duodenal or gastric ulcer, based on the type of questions asked when taking a patient's history, was developed and tested using the following steps: literature reviews, devising the questions, testing the responses to the questions using factor analysis and internal consistency, assessing test-retest reliability, and validating the questionnaire by comparing patient responses to the SF-36 health survey questionnaire. The main sample consisted of 135 patients referred to an out-patient clinic with dyspepsia, and 152 patients in general practice who were not referred to a specialist. The final instrument produced a Cronbach's alpha of 0.72 and an intraclass correlation coefficient of 0.69. Patient scores on the dyspepsia questionnaire had small to moderate correlations with the SF-36 health survey, the largest correlation being with the SF-36 scale of pain. Patient scores were significantly related to general practitioner perceptions of symptom severity, family history of gastric ulcer disease, and whether the patient was referred. The questions asked in taking a clinical history from a patient with dyspepsia and other symptoms suggestive of ulcer disease can be used to construct a valid and reliable measure of the effect of dyspepsia on health.
Citation: McCarthy MJ Jr, Shroyer AL, Sethi GK, Moritz TE, Henderson WG, Grover FL, London MJ, Gibbs JO, Lansky D, Miller D, et al, Self-report measures for assessing treatment outcomes in cardiac surgery patients., Med Care 33: 10 Suppl, OS76-85, Oct, 1995.
Patient self-report measures are increasingly valued as outcome variables in health services research studies. In this article, the authors describe the Functional Status, Health Related Quality of Life, Life Satisfaction, and Patient Satisfaction scales included in the Processes, Structures, and Outcomes of Cardiac Surgery (PSOCS) cooperative study underway within the Department of Veterans Affairs health care system. In addition to reporting on the baseline psychometric characteristics of these instruments, the authors compared preoperative Medical Outcomes Study SF-36 data from the study patients with survey data from a probability sample of the US population and with preoperative data on cardiac surgery patients from a high volume private sector surgical practice. Descriptive analyses indicate that the SF-36 profiles for all of the cardiac patients are highly similar. The Veterans Affairs and private sector patients report diminished physical functioning, physical role functioning, and emotional role functioning as well as reduced energy relative to an age-matched comparison sample. At the same time, however, the Veterans Affairs patients evidenced lower levels of capacity on most of the SF-36 dimensions relative to the private sector patients.
Citation: Jarema M, Konieczynska Z, Glowczak M, Szaniawska A, Meder J, Jakubiak A, [The evaluation of subjective quality of life in patients with schizophrenia or depression], Psychiatr Pol 29: 5, 641-53, Sep-Oct, 1995.
Subjective evaluation of the quality of life was studied in 53 schizophrenics (hospitalized, from the day-hospital, and from the rehabilitation unit) and in 12 depressed patients before and after pharmacological treatment or rehabilitation. The self-evaluation questionnaire SF-36 was used. The subjective quality of life of depressive patients at baseline was low in comparison to the schizophrenics. The best improvement of subjective quality of life after the treatment was found in hospitalized schizophrenic patients. Evaluation of the quality of life both before and after treatment/rehabilitation did not correlate with doctors' estimation of the severity of their illness. Depressive patients expressed more negative opinion regarding their physical condition and social activity than did the schizophrenics. The positive opinion on patients' health status correlated positively with good evaluation of patients' physical condition and good performance at home or work.
Citation: Bombardier C, Melfi CA, Paul J, Green R, Hawker G, Wright J, Coyte P, Comparison of a generic and a disease-specific measure of pain and physical function after knee replacement surgery., Med Care 33: 4 Suppl, AS131-44, Apr, 1995.
Generic and disease-specific health status instruments are commonly used to assess patients' outcomes. The hypothesis that they measure distinct but complementary aspects of patients' quality of life was tested using a sample of patients aged 67 to 99 years who had undergone knee replacement surgery 2 to 7 years previously. Patients' scores on a generic health-related quality-of-life (HRQOL) measure, the SF-36, were compared to those of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the WOMAC was developed specifically for patients with lower extremity arthritis, whereas the SF-36 is aimed at all conditions. A stratified sample of 1,750 Medicare beneficiaries was surveyed and an overall response rate of 80.3% achieved, resulting in 1,193 usable surveys (after adjustment for ineligible, incapacitated, and deceased individuals). The distribution of scores on the three dimensions common to both instruments (i.e., pain, physical function, and overall score) showed consistently higher scores on the WOMAC, on a scale of 0 (worst) to 100 (best), than on the SF-36, indicating less disability from arthritis than from other conditions after knee surgery in this elderly population. Statistically significant differences in the number of people with perfectly healthy scores were detected between the instruments; with regard to pain, 32.2% of the sample reported no pain due to arthritis on the WOMAC, compared with only 13.6% reporting no pain due to any conditions on the SF-36. The figures for physical function and overall score were 9.6% versus 1.4%, and 6.9% versus 0.2%, respectively. Examination for discriminant validity showed that the scores on the two scales followed hypothesized patterns: the WOMAC discriminated better among subjects with varying severity of knee problems, whereas the SF-36 discriminated better among subjects with varying levels of self-reported health status and comorbidity. The results of this study support the inclusion of both a generic and a disease-specific HRQOL measure to assess patient outcomes fully.
Citation: Stacey JH, Miocevich ML, Sacks GE, The effect of ranitidine (as effervescent tablets) on the quality of life of GORD patients., Br J Clin Pract 50: 4, 190-4 196, Jun, 1996.
Patients diagnosed as suffering from symptomatic reflux disease were entered into this comparative, multicentre study based in UK general practice. The study was designed to investigate the symptomatic response and quality of life of these GORD sufferers as they received ranitidine (Zantac effervescent tablets) over a four-week period. All patients initially received ranitidine 150 mg bd for two weeks. Subsequent treatment was allocated according to symptomatic response: responders remained on the initial dose for the remaining two weeks of the study, non-responders had their dosage increased to qds. Quality of life was assessed using the short-form 36 questionnaire (SF-36) both before and two and four weeks after treatment. The GORD sufferers had a significantly worse quality of life than a representative sample of the general population before treatment. After just four weeks of treatment with ranitidine, however, substantial improvements were observed in all domains of the SF-36, to the extent that the quality of life profile of the GORD sufferers became very similar to that of the general population and no significant differences were observed between the groups.
Citation: Wagner AK, Bungay KM, Kosinski M, Bromfield EB, Ehrenberg BL, The health status of adults with epilepsy compared with that of people without chronic conditions., Pharmacotherapy 16: 1, 1-9, Jan-Feb, 1996.
STUDY OBJECTIVES: To examine the feasibility of administering and the psychometric properties of a general health status questionnaire in adults with epilepsy, and to assess the health status of these patients. DESIGN: Prospective, cross-sectional, observational study. SETTING: Neurology clinic of a tertiary care medical center. PATIENTS: One hundred forty-eight ambulatory adults with epilepsy. INTERVENTIONS: Patients completed the SF-36, a general health status questionnaire. Respondent burden and data quality as well as psychometric characteristics were evaluated. Patients' SF-36 scale scores, adjusted for comorbidities, were compared with those of 641 people without chronic conditions with the same sociodemographic characteristics. MEASUREMENTS AND MAIN RESULTS: Administering the SF-36 to adult out-patients with epilepsy is feasible and results are psychometrically sound. Compared with those who were not ill, patients had significantly (p < 0.001) lower (0 = worst, 100 = best) scores in six of the eight SF-36 domains: general health perceptions (57.7 vs 82.1), mental health (61.3 vs 79.6), vitality (53.5 vs 67.8), role limitations owing to physical (69.6 vs 95.0) and emotional problems (67.2 vs 88.4), and social functioning (75.2 vs 89.9). CONCLUSIONS: Lower SF-36 scores may reflect patients' assessments of the balance among epilepsy, seizures, and antiepileptic drug therapy-related effects. Incorporating health status information into therapeutic decision making may help to attain the ultimate goal of improving patients' health.
Citation: van Campen C, Kerkstra A, [Experienced quality of life of somatic nursing home patients: a review of measuring instruments], Tijdschr Gerontol Geriatr 27: 1, 20-8, Feb, 1996.
Research into the quality of life of somatic patients in nursing home is scarce in the Netherlands. In this article, 33 quality of life instruments for somatic nursing home patients are reviewed with respect to content, psychometric characteristics and resident-friendliness. A combination of a health status instrument and a life satisfaction instrument seems most suitable for the assessment of somatic patients in nursing homes: Eight instruments, including six health status instruments (McMaster Health Index Questionnaire, MOS SF-36, Nottingham Health Profile, Sickness Impact Profile, Quality of Well-being scale and COOP/WONCA charts) and two life satisfaction instruments (Philadelphia Geriatric Center Morale Scale and Life Satisfaction Index Z) are qualified and should be further investigated.
Citation: Sullivan M, [Measuring quality of life. A new general and a new tumor specific formulary for evaluation and planning], Lakartidningen 91: 13, 1340-1, Mar 30, 1994.
The generic measure, SF-36, was developed in the US. It covers both functioning and well-being and has proved suitable for clinical outcomes research, patient monitoring and health care planning. To protect the forms and scoring algorithms of the SF-36 and ensure comparability across studies and countries the copyright was placed with Medical Outcomes Trust, a non-profit making organization. Researchers are granted permission through a user agreement procedure. An international team of investigators is developing authorized translations of the SF-36 through the International Quality of Life Assessment (IQOLA) Project, sponsored by Glaxo Research Institute, Research Triangle Park, North Carolina, USA, and Schering-Plough Corporation, Kenilworth, New Jersey, USA. The Swedish test version is currently available on a case-by-case basis at the Health Care Research Unit. The tumor-specific measure, QLQ-C30, was developed and proved reliable in cross-cultural field studies, created by the Quality of Life Study Group within the European Organization for Research and Treatment of Cancer (EORTC). It includes questions on functioning, symptom burden and global quality of life across tumors, supplemented by diagnosis--or therapy-specific additional modules. The instrument is copyrighted and all translations are placed with the Quality of Life Unit at the EORTC Data Center, Brussels. Requests for permission to use the instrument and scoring instructions should be sent to the Center.
Citation: Kutner NG, Schechtman KB, Ory MG, Baker DI, Older adults' perceptions of their health and functioning in relation to sleep disturbance, falling, and urinary incontinence.FICSIT Group., J Am Geriatr Soc 42: 7, 757-62, Jul, 1994.
OBJECTIVE: To investigate variation in older adults' perceived health and functioning that is associated with self-reported sleep disturbance, falling, and urinary incontinence, controlling for self-reported depression, ambulation difficulty, number of chronic conditions, and subjects' sociodemographic characteristics. DESIGN: Multicenter prospective study (FICSIT). SETTING: Persons age 70 and older living in the community evaluated at baseline. PARTICIPANTS: 239 women, 113 men; mean age = 77. MEASUREMENTS: Sleep disturbance score based on EPESE questions, recent falls history (Y/N), incontinent episodes (Y/N), CES-D score, SIP Ambulation score, and 4 MOS SF-36 scale scores. RESULTS: Women were significantly more likely than men to report multiple conditions (sleep disturbance, falling, incontinence) and to report lower levels of functioning as measured by 3 of 4 SF-36 scales. In regression analyses, sleep disturbance and urinary incontinence were significant predictors of perceived limitations in usual role activities because of physical health problems. Depression and ambulation measures significantly predicted scores on all 4 SF-36 scales. CONCLUSIONS: Our analysis suggests that it is important to address depressive symptomatology and ambulation difficulty--which in turn are related to sleep disturbance, falling, and urinary incontinence--in efforts to enhance older adults' perceived health and functioning.
Citation: Wolinsky FD, Stump TE, A measurement model of the Medical Outcomes Study 36-Item Short-Form Health Survey in a clinical sample of disadvantaged, older, black, and white men and women., Med Care 34: 6, 537-48, Jun, 1996.
The authors assess the factorial validity of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) for use in a clinical sample of disadvantaged, older adults with significant comorbidities. Confirmatory factor analysis was performed using LISREL VIII on data obtained from baseline face-to-face interviews with a clinical sample of 1,051 patients who were at risk for acute deterioration of their clinical condition due either to their age alone (75 years or older), or to their age (50 to 74 years old) and major comorbid conditions. An acceptable eight-factor measurement model reflecting the original specification (ie, subscales) of the SF-36 was obtained (chi-square to degrees of freedom ratio = 2.14; root mean squared residual = .055; adjusted goodness of fit index = .90). That model, however, required relaxing the assumptions associated with seven correlated error terms. Moreover, an alternative nine-factor model that allowed the getting sick and getting worse items to form their own factor, labeled health optimism, fit the data significantly better (8 degrees of freedom chi-square improvement = 61; P< 0.0001). Although continued use of the SF-36 in older, disadvantaged, clinical samples is appropriate, further assessment of the underlying measurement model in other samples using confirmatory factor analytic techniques is needed to resolve the issue of correlated error structures and the existence of the health optimism factor.
Citation: Krousel-Wood MA, Re RN, Health status assessment in a hypertension section of an internal medicine clinic., Am J Med Sci 308: 4, 211-7, Oct, 1994.
The authors obtained health status instrument information with the SF-36 and COOP charts distributed in random order (along with selected items from the Hypertension Technology of Patient Experience [TyPE] tool) to patients attending the hypertension section of an internal medicine clinic. The goal was to examine and compare potential associations of clinical, demographic, and/or treatment variables with SF-36/COOP health status scale variables in a nonuniversity urban clinic. One hundred fifty-eight pairs of health status instruments were returned (62% response rate). One hundred (64%) had a diagnosis of hypertension, 81 (51%) were males, 94 (60%) were older than 65 years, and 122 (78%) were white. Clinical, demographic, and treatment measurements were studied using regression analysis; the estimated regressions accounted for 4-32% of the variation in the COOP scales and 8-19% in the SF-36 scales. The number of coexisting diseases, gender, and diagnosis of hypertension were the most frequent significant variables associated with health status scale outcomes for each health status instrument. For most COOP and some SF-36 scales, there was a significant hypertension by gender interaction indicating that women with a hypertension diagnosis report better health status than women seen for other conditions; hypertension diagnosis had little effect on men's reported health status for most scales. Further study is necessary to confirm these results, yet the regression models developed in this study suggest that health status as assessed by these instruments is affected by multiple and not always obvious factors.
Citation: McCarthy ML, MacKenzie EJ, Bosse MJ, Copeland CE, Hash CS, Burgess AR, Functional status following orthopedic trauma in young women., J Trauma 39: 5, 828-36; discussion 836-7, Nov, 1995.
OBJECTIVE: To evaluate the general health status and sexual function of women following serious orthopedic injury. METHODS: Women aged 16-44 who were treated at a level I trauma center between 1986 and 1992 for a fracture to the pelvis or lower extremity were interviewed by telephone. The interview included the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) supplemented by questions about sexual function. The SF-36 is a measure of outcome from the respondent's point of view and consists of 36 items representing eight health concepts. RESULTS: Of 289 eligible women, 233 (81%) were interviewed (123 pelvic fracture; 110 lower extremity fracture). Their mean Injury Severity Score was 17.9. Compared to age- and gender-standardized norms, study patients as a group scored significantly worse (lower scores) on all dimensions of the SF-36 except mental health (p < 0.05). Of the women interviewed, 45% reported feeling less sexually attractive due to their injury, and 39% reported a decrease in sexual pleasure. Women who reported arthritis that was attributed to their fracture had significantly poorer health outcomes than study subjects who did not. The most significant predictor of deviations from SF-36 norms was the presence of one or more comorbid chronic conditions. CONCLUSION: The results underscore the importance of considering comorbidities when evaluating health outcomes following major trauma. In addition, the relatively high rates of reported change in sexual function after injury argue for more attention to these issues in both clinical practice and outcomes research.
Citation: Mangione CM, Phillips RS, Lawrence MG, Seddon JM, Orav EJ, Goldman L, Improved visual function and attenuation of declines in health-related quality of life after cataract extraction., Arch Ophthalmol 112: 11, 1419-25, Nov, 1994.
OBJECTIVE: To measure the effect of cataract extraction and lens implantation on elderly persons' health-related quality of life and on their ability to perform visual activities. DESIGN: Evaluations of health status were conducted preoperatively and at 3 and 12 months after surgery on patients scheduled for cataract extraction. SETTING: Patients were enrolled from the General Eye Service of the Massachusetts Eye and Ear Infirmary and 33 Boston practices. PATIENTS: The cohort consisted of 464 patients aged 65 years or older who were identified from the surgical schedule of the Massachusetts Eye and Ear Infirmary. At 3 to 12 months after surgery, 458 (99%) of the participants were successfully contacted. Health-related quality of life data were available for 419 (90%) to assess changes after surgery. MAIN OUTCOME MEASURES: Ophthalmologic examinations were performed preoperatively and during the follow-up period. The Activities of Daily Vision Scale (ADVS) and the Medical Outcomes Study 36-item short from (SF-36) were administered before surgery and at 3 and 12 months postoperatively to assess changes in health status. RESULTS: At 12 months after surgery, 95% of patients had improved Snellen visual acuity, "80%" had improved ADVS scores, but only 36% had improved SF-36 physical functioning. Average scores on seven of eight SF-36 subscales worsened at 12 months. Patients with improved ADVS scores had significantly smaller declines across all SF-36 dimensions except for role limitations due to emotional problems. CONCLUSION: Improved visual function after cataract surgery was associated with better health-related quality of life, suggesting that age-related declines in health may be attenuated by improvements in visual function.
Citation: Osterhaus JT, Townsend RJ, Gandek B, Ware JE Jr, Measuring the functional status and well-being of patients with migraine headache., Headache 34: 6, 337-43, Jun, 1994.
OBJECTIVE: Compare adult migraineurs' health related quality of life to adults in the general U.S. population reporting no chronic conditions, and to samples of patients with other chronic conditions. METHODS: Subjects (n = 845) were surveyed 2-6 months after participation in a placebo-controlled clinical trial and asked to complete a questionnaire including the SF-36 Health Survey, a migraine severity measurement scale and demographics. Results were adjusted for severity of illness and comorbidities. Scores were compared with responses to the same survey by the U.S. sample and by patients with other chronic conditions. RESULTS: Response rate was 67%. After adjustment for comorbid conditions, SF-36 scale scores were significantly (P 0.001) lower in migraineurs, relative to age and sex-adjusted norms for the U.S. sample with no chronic conditions. Some health dimensions were more affected by migraine than other chronic conditions, while other dimensions were less affected by migraine. Measures of bodily pain, role disability due to physical health and social functioning discriminated best between migraineurs, the U.S. sample, and patients with other chronic conditions. Patients reporting moderate, severe and very severe migraines scored significantly (P < or = 0.001) lower on five of the eight SF-36 scales than the U.S. sample. CONCLUSIONS: Migraine has a unique, significant quality of life burden.
Citation: Krumholz HM, McHorney CA, Clark L, Levesque M, Baim DS, Goldman L, Changes in health after elective percutaneous coronary revascularization. A comparison of generic and specific measures., Med Care 34: 8, 754-9, Aug, 1996.
OBJECTIVES. This study determines changes in health-related quality of life after elective percutaneous transluminal coronary angioplasty and compares generic and specific measures. METHODS. Changes in health-related quality of life were measured in consecutive, symptomatic patients undergoing elective percutaneous coronary revascularization using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), the Specific Activity Scale (SAS), and the Canadian Cardiovascular Society Classification (CCSC). The patients were interviewed as out-patients before admission and at least 6 months later. RESULTS. There were significant changes in the following SF-36 measures: physical functioning (postscore minus prescore = 19.1 +/- 24.1), role limitations due to physical-health problems (40.4 +/- 47.2), bodily pain (19.9 +/- 29.3), vitality (12.9 +/- 25.1), social functioning (20.0 +/- 33.1), role limitations due to emotional-health problems (26.7 +/- 49.0), and general mental health (7.1 +/- 21.2). General health perceptions did not change significantly. Internal-consistency reliability coefficients for these measures ranged from 0.73 to 0.91. There also was significant improvement in the CCSC class, but the SAS class did not change significantly. Overall, the SF-36 role-physical scale was the most responsive to changes after elective percutaneous coronary revascularization, followed by the CCSC and the SF-36 physical functioning scale. CONCLUSIONS. Although this study cannot determine the causal role of elective percutaneous coronary revascularization in these changes, it provides support for the usefulness of these measures in future evaluations of this intervention.
Citation: Keoghane SR, Lawrence KC, Jenkinson CP, Doll HA, Chappel DB, Cranston DW, The Oxford Laser Prostate Trial: sensitivity to change of three measures of outcome., Urology 47: 1, 43-7, Jan, 1996.
OBJECTIVES. To evaluate the sensitivity to change of outcome measures in a double-blind randomized controlled trial of transurethral resection of the prostate (TURP) and contact laser prostatectomy. METHODS. A total of 152 patients were randomized to TURP or contact laser prostatectomy using the Surgical Laser Technology (SLT) system. Preoperative data were obtained using a self-administered questionnaire containing the American Urological Association (AUA-7) symptom score, the bothersome score (benign prostatic hyperplasia impact index), and the Short Form-36 health status questionnaire (SF-36). Follow-up was at 1 and 3 months. Effect size scores were calculated to indicate the extent of change from baseline to follow-up. RESULTS. Data were available on 148 patients: 72 received laser therapy and 76 received TURP. Mean change in AUA-7 score at 3 months was 7.3 in the laser arm, compared with 11.9 in the TURP arm (P < 0.05). Furthermore, substantial change was detected in both groups on the bothersome score. However, very few significant differences in SF-36 dimension scores from baseline to 3 months were detected. CONCLUSIONS. The SF-36 at both baseline and follow-up indicated a similar level of health status as that reported in the general population. Subsequently, the measure did not improve on any dimensions. Our data support the claim of some researchers that shorter disease-specific indices are vital to the evaluation of treatment regimens in clinical trials, especially when the general health of the patients is similar to that of the population.
Citation: Tilly KF, Belton AB, McLachlan JF, Continuous monitoring of health status outcomes: experience with a diabetes education program., Diabetes Educ 21: 5, 413-9, Sep-Oct, 1995.
A diabetes education program was evaluated using an outcomes management system. Data concerning health status outcomes, including glycemic control (HbA1c), diabetes-related quality of life, and general health-related quality of life, were collected over a 15-month period. This information was collected for each clinic patient at entry into the program and again at a 6-month follow-up session. Patients improved significantly in all categories of outcomes. Newly diagnosed patients showed significantly greater reduction in HbA1c than did patients with a history of diabetes. Health-related quality of life, as measured by symptoms and the SF-36, improved independent of glycemic control. Despite the difficulties of interpreting results from this one-group, pretest-posttest design, the study demonstrated the value of a multidimensional approach to outcome assessment and program evaluation.
Citation: Usherwood T, Jones N, Self-perceived health status of hostel residents: use of the SF-36D health survey questionnaire. Hanover Project Team., J Public Health Med 15: 4, 311-4, Dec, 1993.
As part of a project to assess the health needs of homeless people in Sheffield, a survey of hostel residents was undertaken with the aim of measuring self-perceived health and health service use among respondents. The survey instrument incorporated the SF-36D short-form health survey questionnaire. One hundred and four (56 per cent) adult hostel residents responded. Respondents reported high levels of health service use, and poor average perceived health in comparison with the general population. Three-quarters of respondents were identified as being at risk of major depressive illness. There was a strong association between risk of major depression and recent hospital contact, current use of prescribed medication, and low scores on the social function, mental health, energy/vitality, pain and general health dimensions of the SF-36. The implications of these findings are discussed.
Citation: Jette DU, Downing J, The relationship of cardiovascular and psychological impairments to the health status of patients enrolled in cardiac rehabilitation programs., Phys Ther 76: 2, 130-9; discussion 140-8, Feb, 1996.
BACKGROUND AND PURPOSE: Understanding the causes of differences in disability among individuals is an important research focus for rehabilitation professionals. The purpose of this study was to examine the relationship between health status and the impairments commonly associated with cardiovascular pathophysiology. SUBJECTS: The subjects were patients (N=789) enrolled in 13 cardiac rehabilitation programs in Massachusetts. METHODS: Data were collected on psychological and physiological impairments, demographic characteristics, and health status. Multivariate analyses were used to determine which measures of impairment and patient characteristics were related to health status. RESULTS: Psychological impairment was related to all scales of the MOS 36-item Short-Form Health Survey (SF-36). Very few measures of physiological impairment and individual characteristics were related to SF-36 scores. The models accounted for 16% to 57% of the variability of the instrument's scales. CONCLUSION AND DISCUSSION: In patients entering cardiac rehabilitation, psychological distress is related to poor health in both the physical and psychological dimensions. Variability in health status is not well explained by traditional measures of impairment or demographic characteristics. Physical therapists working to address their patients' health needs must consider collecting data, setting goals, and devising interventions that address psychological impairment.
Citation: Mackenzie R, Dixon AK, Keene GS, Hollingworth W, Lomas DJ, Villar RN, Magnetic resonance imaging of the knee: assessment of effectiveness., Clin Radiol 51: 4, 245-50, Apr, 1996.
OBJECTIVES: To quantify how magnetic resonance imaging (MRI) influences clinicians' diagnoses, diagnostic confidence and management plans in patients with knee problems. To investigate whether these changes can bring about an improvement in health. METHODS: This was a prospective observational study on all patients referred to a regional unit for MRI of the knee over a 6-month-period. Data on diagnosis, diagnostic confidence and proposed management before MRI was compared with diagnoses and actual management after MRI. In addition, short form 36 item (SF-36) health survey data was collected at referral and again 6 months later. RESULTS: Three hundred and thirty-two patients were entered into the study. MRI led to previously unsuspected diagnosis in 69 of 269 patients with available data. When MRI confirmed the clinical diagnosis, significant improvements in clinicians' diagnostic confidence were found (P < 0.01 for medical meniscus, P < 0.05 lateral meniscus, P < 0.05 anterior cruciate). MRI led to a change in management in 180 (63%) of 288 patients (where data available). There was a significant shift away from surgical management after MRI (P < 0.01). SF-36 results were available in 206 patients. There was a significant improvement over time in five of the eight SF-36 scales (four at P < 0.001, one at P < 0.01). CONCLUSIONS: Magnetic resonance imaging significantly influences clinicians' diagnoses and management plans. These patients, examined by MRI, also recorded an improvement in health related quality of life.
Citation: Coulter A, Peto V, Jenkinson C, Quality of life and patient satisfaction following treatment for menorrhagia., Fam Pract 11: 4, 394-401, Dec, 1994.
This prospective cohort study of patients who consulted general practitioners complaining of excessive menstrual bleeding measured changes in quality of life and patients' satisfaction following different forms of treatment for menorrhagia. Three hundred and forty-eight patients were followed-up for 18 months using self-completion questionnaires which included generic measurements of health-related quality of life (SF-36) and a disease-specific questionnaire to measure the social impact of menstrual symptoms. Only 15 patients (4%) received no active treatment, 132 (38%) underwent surgical treatment (hysterectomy or endometrial resection), and the remainder were prescribed drugs. Those in the surgical group with both moderate and severe symptoms experienced significant improvements in their quality of life. Patients with moderate symptoms who did not undergo surgery improved in the social functioning and energy dimensions of the SF-36, but those with severe symptoms who received drug treatment only experienced no significant quality-of-life benefits. Patients who had not had surgery were significantly more likely to be dissatisfied with their treatment (21%) than those in the surgical group (5%). Since menorrhagia can have adverse effects on many aspects of a patient's daily life, it is important to measure the effects of treatment on quality of life. This study has demonstrated the feasibility of doing so.
Citation: Mahler DA, Mackowiak JI, Evaluation of the short-form 36-item questionnaire to measure health-related quality of life in patients with COPD., Chest 107: 6, 1585-9, Jun, 1995.
STUDY OBJECTIVE: To evaluate the short-form 36-item questionnaire (SF-36) as an instrument for measuring health-related quality of life (HRQL) in patients with symptomatic COPD. DESIGN: Observational data at a single point in time. SETTING: Out-patient pulmonary clinic. PATIENTS: Fifty male patients with COPD and no significant comorbidity. MEASUREMENTS AND RESULTS: HRQL was assessed with the SF-36, which consists of 36 questions that cover nine health domains. Clinical ratings of dyspnea were measured by the multidimensional baseline dyspnea index (BDI). Pulmonary function tests included forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1), and maximal inspiratory mouth pressure (PImax). The mean (+/- SD) age of the patients was 72 +/- 8 years. The BDI focal score was 5.6 +/- 2.3, FEV1 was 1.32 +/- 0.60 L (48 +/- 22% pred), and PImax was 62 +/- 23 cm H2O. The BDI focal score was significantly correlated with seven of nine components of the SF-36 (range of r, 0.42 to 0.91; p < 0.05). The FEV1 percent of predicted and PImax were significantly correlated with five of nine health components (range of r, 0.30 to 0.65 and 0.31 to 0.61, respectively). Using linear regression model analysis with the different SF-36 components as the dependent variable and BDI, FVC, FEV1, and PImax as independent variables, the BDI score was the only significant predictor of social and physical functioning, role-physical, vitality, pain, health perceptions, and health transition (p < 0.05). CONCLUSIONS: The SF-36 is a valid instrument to measure HRQL in patients with COPD. The severity of dyspnea but not respiratory function was a significant predictor of various components of HRQL.
Citation: Klassen A, Fitzpatrick R, Jenkinson C, Goodacre T, Should breast reduction surgery be rationed? A comparison of the health status of patients before and after treatment: postal questionnaire survey., BMJ 313: 7055, 454-7, Aug 24, 1996.
OBJECTIVES: To assess the health status of patients before and after breast reduction surgery and to make comparisons with the health status of women in the general population. DESIGN: Postal questionnaire survey sent to patients before and six months after surgery. SETTING: The three plastic surgery departments in the Oxford Regional Health Authority, during April to August 1993. SUBJECTS: 166 women (over the age of 16 years) referred for breast reduction; scores from the "short form 36" (SF-36) health questionnaire completed by women in the 1991-2 Oxford healthy life survey. MAIN OUTCOME MEASURES: Health status of breast reduction patients before and after surgery as assessed by the SF-36, the 28 item general health questionnaire, and Rosenberg's self esteem scale; comparisons between the health status of breast reduction patients and that of women in the general population; outcome of surgery as assessed retrospectively by patients. RESULTS: Differences between the health status of breast reduction patients and that of women in the general population were detected by the SF-36 both before and after surgery. Breast reduction surgery produced substantial change in patients' physical, social, and psychological function. The proportion of cases of possible psychiatric morbidity according to the general health questionnaire fell from 41% (22/54) before surgery to 11% (6/54) six months after treatment. Eighty six per cent (50/58) of patients expressed great satisfaction with the surgical result postoperatively. CONCLUSION: The study provides empirical evidence that supports the inclusion of breast reduction surgery in NHS purchasing contracts.
Citation: Ruta DA, Garratt AM, Leng M, Russell IT, MacDonald LM, A new approach to the measurement of quality of life. The Patient-Generated Index., Med Care 32: 11, 1109-26, Nov, 1994.
Quality of life has been defined as "the extent to which our hopes and ambitions are matched by experience." To improve a patient's quality of life through medical care would be to "narrow the gap between a patient's hopes and expectations and what actually happens." Using the above definition as a conceptual basis, we produced a self-administered, Patient-Generated Index (PGI) of quality of life. The PGI was completed by 359 patients presenting with low back pain. The validity of the measure was assessed by correlating patients' PGI scores with a well-validated health profile, the Short-Form 36-item Health Survey (SF-36), and with their scores on a clinical back pain questionnaire. Stepwise multiple regression was then used to model the relationship between the PGI score and the SF-36. Patients' PGI scores showed a high correlation with SF-36 scales measuring pain, social functioning, and role limitations attributable to physical problems, and with the clinical questionnaire. Together with whether a person was retired or not, these health variables were able to explain 25% of the variance in PGI scores. Patient generated index scores were significantly lower in patients referred to hospital compared with those managed solely in general practice and tended to reflect the general practitioner's assessment of symptom severity. We conclude that it is possible to construct a questionnaire that quantifies the effect of a medical condition on patients' quality of life in a way that has meaning and relevance in the context of their daily lives. The PGI has considerable potential for routine use in a wide range of clinical conditions for which the measurement of outcome has hitherto proved very difficult.
Citation: Khan IH, Garratt AM, Kumar A, Cody DJ, Catto GR, Edward N, MacLeod AM, Patients' perception of health on renal replacement therapy: evaluation using a new instrument., Nephrol Dial Transplant 10: 5, 684-9, , 1995.
Patients' perception of their health is an important outcome measure in the management of chronic disease. Comparing that perception from patients receiving different forms of renal replacement therapy (RRT) with data from the general population could be used to monitor the effectiveness of treatment. The short form 36 (SF-36) questionnaire is a general measure of health status which has been validated in the UK and uses eight health scales comprising physical function, social function, role limitation (physical and emotional), mental health, energy, pain and overall health. Using the SF-36 questionnaire, the perception of health of patients receiving RRT was compared with data from healthy control subjects. One hundred and seventy-two of 185 (93%) patients receiving RRT--transplant (n = 102), haemodialysis (n = 43), and peritoneal dialysis (n = 27) completed the questionnaire; scores were compared with those from 542 healthy control subjects. The perception of health of haemodialysis and peritoneal dialysis patients was significantly worse than transplanted patients and controls in six of the eight scales (P < 0.05 dialysis versus transplant and controls). That of transplanted patients was worse in only two and better in one of the eight scales compared with the general population (P < 0.05). Patients were also stratified into low, medium, and high-risk groups based on age and comorbidity and were analysed irrespective of treatment modality. Scores were significantly different across the risk groups in five of the eight scales. We conclude that the SF-36 questionnaire is acceptable to patients on RRT and enables the perception of health of patients receiving RRT to be compared with that of the general population.(ABSTRACT TRUNCATED AT 250 WORDS)
Citation: Patrick DL, Deyo RA, Atlas SJ, Singer DE, Chapin A, Keller RB, Assessing health-related quality of life in patients with sciatica., Spine 20: 17, 1899-908; discussion 1909, Sep 1, 1995.
STUDY DESIGN. This study analyzed health-related quality-of-life measures and other clinical and questionnaire data obtained from the Maine Lumbar Spine Study, a prospective cohort study of persons with low back problems. OBJECTIVE. For persons with sciatica, back pain-specific and general measures of health-related quality-of-life were compared with regard to internal consistency, construct validity, reproducibility, and responsiveness in detecting small changes over a 3-month period. SUMMARY OF BACKGROUND DATA. Data were collected from 427 participants with sciatica. Baseline in-person interviews were conducted with surgical and medical patients before treatment and by mail at 3 months. METHODS. Health-related quality-of-life measures included symptoms (frequency and bothersomeness of pain and sciatica) functional status and well-being (modified back pain-specific Roland scale and Medical Outcomes Study 36-item Short Form Health Survey (SF-36), and disability (bed rest, work loss, and restricted activity days). RESULTS. Internal consistency of measures was high. Reproducibility was moderate, as expected after a 3-month interval. The SF-36 bodily pain item and the modified Roland measure demonstrated the greatest amount of change and were the most highly associated with self-rated improvement. The specific and generic measures changed in the expected direction, except for general health perceptions, which declined slightly. A high correlation between clinical findings or symptoms and the modified Roland measure, SF-36, and disability days indicated a high degree of construct validity. CONCLUSIONS. These measures performed well in measuring the health-related quality-of-life of patients with sciatica. The modified Roland and the physical dimension of the SF-36 were the measures most responsive to change over time, suggesting their use in prospective evaluation. Disability day measures, although valuable for assessing the societal impact of dysfunction, were less responsive to changes over this short-term follow-up of 3 months.
Citation: Okamoto LJ, Noonan M, DeBoisblanc BP, Kellerman DJ, Fluticasone propionate improves quality of life in patients with asthma requiring oral corticosteroids., Ann Allergy Asthma Immunol 76: 5, 455-61, May, 1996.
BACKGROUND: Fluticasone propionate is a potent inhaled corticosteroid that is effective in improving pulmonary function and symptoms in patients with asthma. OBJECTIVE: To evaluate the effects of fluticasone propionate on quality of life in patients with severe asthma requiring oral corticosteroids. METHODS: A total of 96 patients with severe asthma participated in a randomized, double-blind, placebo-controlled, parallel-group, oral steroid-sparing study. Patients received fluticasone propionate aerosol, 750 or 1000 micrograms bid, or placebo for 16 weeks; 91 of these patients continued in a 1-year open-label study, in which everyone initially received fluticasone propionate, 1000 micrograms bid. At regular intervals, patients completed the Medical Outcomes Study Short Form-36 (SF-36), a general health status questionnaire measuring eight dimensions of quality of life, plus one question on change in health from the previous year. RESULTS: Compared with the US population, patients scored significantly lower at baseline for five of eight SF-36 dimensions (P < .01). After 16 weeks, patients receiving fluticasone propionate, 1000 micrograms, improved significantly (P < or = .02) in physical functioning, role-physical, general health, and change in health, compared with the placebo group. After 1 year of open-label treatment with fluticasone propionate, these improvements were maintained. SF-36 scores in the placebo group during the double-blind period either worsened or remained unchanged; however, when these patients were switched to fluticasone propionate during the open-label period, their SF-36 scores also improved. Forced expiratory volume in 1 second (FEV1) at the end of the double-blind period was positively correlated with mean quality of life scores on physical functioning, role-physical, vitality, social functioning, and change-in-health status. CONCLUSION: Health-related quality of life improved in patients with severe asthma following 16 weeks of treatment with fluticasone propionate, 1000 micrograms bid. These improvements were maintained during subsequent fluticasone propionate treatment over a 1-year period.
Citation: Langfitt JT, Comparison of the psychometric characteristics of three quality of life measures in intractable epilepsy., Qual Life Res 4: 2, 101-14, Apr, 1995.
Understanding how epilepsy affects an individual's quality of life (QOL) requires reliable and valid QOL measures. Analyses of reliability and validity rarely examine measures obtained in the same sample, making comparisons among measures difficult. We report analyses of internal consistency reliability, face, content, construct and criterion validity for the Epilepsy Surgery Inventory-55 (ESI-55, a measure based on the SF-36 Health Survey), the Sickness Impact Profile (SIP) and the Washington Psychosocial Seizure Inventory (WPSI) administered concurrently in the same sample of intractable epilepsy patients. Results generally support the validity of all three measures in assessing the aspects of QOL they were designed to address. The ESI-55 and SIP assess a broad, multi-dimensional construct of QOL in epilepsy, compared with the more specific focus of the WPSI on psychological and social adjustment. Judged by objective psychometric criteria, the ESI-55 and SIP are preferred over the WPSI in studies of the broad impact of epilepsy on quality of life.
Citation: Weinberger M, Kirkman MS, Samsa GP, Cowper PA, Shortliffe EA, Simel DL, Feussner JR, The relationship between glycemic control and health-related quality of life in patients with non-insulin-dependent diabetes mellitus., Med Care 32: 12, 1173-81, Dec, 1994.
The relationship between glycemic control and health-related quality of life was examined in patients with non-insulin-dependent diabetes mellitus (NIDDM). Within the context of a randomized controlled trial, 275 patients with NIDDM receiving primary care from a Veteran's Administration general medical clinic were enrolled and monitored for 1 year. Glycemic control (glycosylated hemoglobin levels) and health-related quality of life (Medical Outcomes Study Short-Form 36-item Health Survey [SF-36]) were assessed at baseline and at 1 year. Multivariate regression modeling using baseline and change scores during a 1-year period did not find a linear or curvilinear relationship between glycosylated hemoglobin and SF-36 scores (P = .15); this was true even after controlling for five covariates identified a priori (insulin use, number of diabetic complications, duration of diabetes, education, number of hyper-, or hypoglycemic episodes during the preceding month). Health services researchers and clinicians alike need to be aware that these two important outcomes may not be directly related. This lack of association could contribute to the high noncompliance rates observed among patients prescribed complex diabetic regimens. Unless patients perceive a benefit from following such regimens, good glycemic control may continue to be an elusive therapeutic goal, especially in patients with long-standing disease.
Citation: Ware J Jr, Kosinski M, Keller SD, A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity., Med Care 34: 3, 220-33, Mar, 1996.
Regression methods were used to select and score 12 items from the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) to reproduce the Physical Component Summary and Mental Component Summary scales in the general US population (n=2,333). The resulting 12-item short-form (SF-12) achieved multiple R squares of 0.911 and 0.918 in predictions of the SF-36 Physical Component Summary and SF-36 Mental Component Summary scores, respectively. Scoring algorithms from the general population used to score 12-item versions of the two components (Physical Components Summary and Mental Component Summary) achieved R squares of 0.905 with the SF-36 Physical Component Summary and 0.938 with SF-36 Mental Component Summary when cross-validated in the Medical Outcomes Study. Test-retest (2-week)correlations of 0.89 and 0.76 were observed for the 12-item Physical Component Summary and the 12-item Mental Component Summary, respectively, in the general US population (n=232). Twenty cross-sectional and longitudinal tests of empirical validity previously published for the 36-item short-form scales and summary measures were replicated for the 12-item Physical Component Summary and the 12-item Mental Component Summary.

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