Andrew M. Garratt

Quality of life measurement: bibliographic study of patient assessed health outcome measures

Abstract Objectives: To assess the growth of quality of life measures and to examine the availability of measures across specialties. Design: Systematic searches of electronic databases to identify developmental and evaluative work relating to health outcome measures assessed by patients. Main outcome measures: Types of measures: disease or population specific, dimension specific, generic, individualised, and utility. Specialties in which measures have been developed and evaluated. Results: 3921 reports that described the development and evaluation of patient assessed measures met the inclusion criteria. Of those that were classifiable, 1819 (46%) were disease or population specific, 865 (22%) were generic, 690 (18%) were dimension specific, 409 (10%) were utility, and 62 (1%) were individualised measures. During 1990-9 the number of new reports of development and evaluation rose from 144 to 650 per year. Reports of disease specific measures rose exponentially. Over 30% of evaluations were in cancer, rheumatology and musculoskeletal disorders, and older peoples health. The generic measures—SF-36, sickness impact profile, and Nottingham health profile—accounted for 612 (16%) reports. Conclusions: In some specialties there are numerous measures of quality of life and little standardisation. Primary research through the concurrent evaluation of measures and secondary research through structured reviews of measures are prerequisites for standardisation. Recommendations for the selection of patient assessed measures of health outcome are needed.

Quality of life in older people : A structured review of generic self-assessed health instruments

Objective: To review evidence relating to the measurement properties of multi-item generic patient or self-assessed measures of health in older people. Methods: Systematic literature searches to identify instruments. Pre-defined criteria relating to reliability, validity and responsiveness. Results: 122 articles relating to 15 instruments met the inclusion criteria. The most extensive evidence was found for the SF-36, COOP Charts, EQ-5D, Nottingham Health Profile (NHP) and SIP. Four instruments have evidence of both internal consistency and test–retest reliability – NHP, SF-12, SF-20, SF-36. Four instruments lack evidence of reliability – HSQ-12, IHQL, QWB, SQL. Most instruments were assessed for validity through comparisons with other instruments, global judgements of health, or clinical and socio-demographic variables. Five instruments lack evidence of responsiveness – GQL, HSQ-12, IHQL, QLI and QWB. Conclusion: There is good evidence for reliability, validity and responsiveness for the SF-36, EQ-5D and NHP. There is more limited evidence for the COOP, SF-12 and SIP. The SF-36 is recommended where a detailed and broad ranging assessment of health is required, particularly in community dwelling older people with limited morbidity. The EQ-5D is recommended where a more succinct assessment is required, particularly where a substantial change in health is expected. Instrument content should be assessed for relevance before application. The concurrent evaluation of generic instruments in older people is recommended.

Patient-assessed health outcome measures for diabetes: a structured review

Aims To identify available disease‐specific measures of health‐related quality of life (HRQL) for diabetes and to review evidence for the reliability, validity and responsiveness of instruments.

SF 36 health survey questionnaire: II. Responsiveness to changes in health status in four common clinical conditions.

OBJECTIVE--To assess the responsiveness of the SF 36 health survey questionnaire to changes in health status over time for four common clinical conditions. DESIGN--Postal questionnaires at baseline and after one years follow up, with two reminders at two week intervals if necessary. SETTING--Clinics and four training general practices in Grampian region in the north east of Scotland. PATIENTS--More than 1,700 patients aged 16 to 86 years with one of four conditions: low back pain, menorrhagia, suspected peptic ulcer, and varicose veins; and a random sample of 900 members of the local general population for comparison. MAIN MEASURES--A transition question measuring change in health and the eight scales of the SF 36 health survey questionnaire; standardised response means (mean change in score for a scale divided by the standard deviation of the change in scores) used to quantify the instruments responsiveness to changes in perceived health status, and comparison of patient scores at baseline and follow up with those of the general population. RESULTS--The response rate exceeded 75% in a patient population. Changes across the SF 36 questionnaire were associated with self reported changes in health, as measured by the transition question. The questionnaire showed significant improvements in health status for all four clinical conditions, whether in referred or non-referred patients. For patients with suspected peptic ulcer and varicose veins the SF 36 profiles at one year approximate to the general population. CONCLUSIONS--These results provide the first evidence of the responsiveness of the SF 36 questionnaire to changes in perceived health status in a patient population in the United Kingdom.

A randomised comparison of medical and hysteroscopic management in women consulting a gynaecologist for treatment of heavy menstrual loss

Objectives To compare medical with hysteroscopic management in women referred to a gynaecologist complaining of heavy menstrual loss.

Responsiveness of the SF-36 and a condition-specific measure of health for patients with varicose veins

Approaches to measuring patient perceptions of outcome for varicose veins were tested using a postal questionnaire incorporating a clinically derived specific measure of varicose veins severity and the SF-36 health survey. The questionnaire was administered to 373 patients with varicose veins, 287 of whom had been referred to hospital for their varicose veins and 86 who had just consulted a general practitioner for the condition. The response rate exceeded 75%. Test-retest reliability was assessed by mailing patients a similar questionnaire at two weeks. The validity of the two instruments was assessed by comparing patient scores to general practitioner ratings of symptom severity and complications associated with varicose veins. Standardized response means (mean change in scores divided by the standard deviation of the change in scores) were used to quantify and compare the responsiveness of the two measures. Levels of test-retest reliability, as assessed by the intraclass correlation coefficient, were acceptable and the instruments appear to have good levels of validity. Patients who were or were not admitted to hospital for surgery on their veins had significant improvements in perceived health status on both the specific measure and the SF-36. The specific measure was the most responsive to changes in health status for both patients who were admitted to hospital for surgery and those receiving alternative forms of management. These two approaches might be suitable as part of a package of outcome measures for use in clinical trials to assess the effectiveness of different interventions for varicose veins.

The UK IBDQ—A British version of the inflammatory bowel disease questionnaire: development and validation

Measurement of health-related quality of life (HRQL) is becoming more important in studies of patients with inflammatory bowel disease. The McMaster IBDQ is the most widely used HRQL instrument for these patients. However, its use with patients in the United Kingdom has not been validated. This study develops and validates a UK version of the McMaster IBDQ (UK IBDQ). The UK IBDQ was tested with two samples of patients for its reliability, validity, reproducibility, and responsiveness. The first sample consisted of 180 patients participating in a randomized clinical trial. The second was recruited from members of the National Association for Colitis and Crohns Disease. Reliability of the subscales and the summary score of the UK IBDQ is demonstrated by Cronbachs alpha and item-total correlations. Their validity is demonstrated by their correlations with SF-36 subscales and an empirical index of disease activity. Good intraclass correlations and responsiveness ratios show their reproducibility and responsiveness. The findings support the reliability, validity, reproducibility, and responsiveness of the UK IBDQ and its acceptability to patients in UK.

Assessment of patients with menorrhagia: How valid is a structured clinical history as a measure of health status?

A patient-administered questionnaire for menorrhagia based on the type of questions asked when taking a gynaecological history was developed and tested using the following steps: literature reviews, devising the questions, testing responses for internal consistency and test-retest reliability and validating the questionnaire by comparing patients scores with their responses to the SF-36 general health measure, and with family practitioner perceptions of severity. The main sample consisted of 351 women with menorrhagia, 246 referred to gynaecology ambulatory clinics and 105 from four large training practices in North-east Scotland. Following testing, two questions were discarded from the questionnaire. The final questionnaire demonstrated a good level of reliability and the resulting patient scores correlated significantly with their scores on the scales making up the general health measure. The questions asked in taking a clinical history from a woman with menorrhagia can be used to construct a valid and reliable measure of health status. This clinical measure may be a useful guide in selection for treatment and in the assessment of patient outcome following treatment.

SF 36 health survey questionnaire: I. Reliability in two patient based studies.

OBJECTIVE--To assess the reliability of the SF 36 health survey questionnaire in two patient populations. DESIGN--Postal questionnaire followed up, if necessary, by two reminders at two week intervals. Retest questionnaires were administered postally at two weeks in the first study and at one week in the second study. SETTING--Outpatient clinics and four training general practices in Grampian region in the north east of Scotland (study 1); a gastroenterology outpatient clinic in Aberdeen Royal Hospitals Trust (study 2). PATIENTS--1787 patients presenting with one of four conditions: low back pain, menorrhagia, suspected peptic ulcer, and varicose veins and identified between March and June 1991 (study 1) and 573 patients attending a gastroenterology clinic in April 1993. MAIN MEASURES--Assessment of internal consistency reliability with Cronbachs alpha coefficient and of test-retest reliability with the Pearson correlation coefficient and confidence interval analysis. RESULTS--In study 1, 1317 of 1746 (75.4%) correctly identified patients entered the study and in study 2, 549 of 573 (95.8%). Both methods of assessing reliability produced similar results for most of the SF 36 scales. The most conservative estimates of reliability gave 95% confidence intervals for an individual patients score difference ranging from -19 to 19 for the scales measuring physical functioning and general health perceptions, to -65.7 to 65.7 for the scale measuring role limitations attributable to emotional problems. In a controlled clinical trial with sample sizes of 65 patients in each group, statistically significant differences of 20 points can be detected on all eight SF 36 scales. CONCLUSIONS--All eight scales of the SF 36 questionnaire show high reliability when used to monitor health in groups of patients, and at least four scales possess adequate reliability for use in managing individual patients. Further studies are required to test the feasibility of implementing the SF 36 and other outcome measures in routine clinical practice within the health service.

The impact of using a partially randomised patient preference design when evaluating alternative managements for heavy menstrual bleeding.

Objective To identify the advantages and disadvantages of using a partially randomised patient preference design rather than a conventional randomised controlled design when evaluating alternative managements for heavy menstrual bleeding.