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Biomedical subjects

A M Garratt

Publications and source records attributed to A M Garratt.

34 records · Page 2Linked to original sources

Patient centred assessment of quality of life for patients with four common conditions.

OBJECTIVES: To assess the reliability, validity, and responsiveness of a new quality of life measure, the patient generated index (PGI) of quality of life, in patients with four common clinical conditions. DESIGN: Prospective one year follow up study. SETTING: Outpatient departments and four general practices in Grampian, Scotland. SUBJECTS: 1746 patients consulting a general practitioner in one of four practices, or referred to outpatients from all Grampian practices over a four month period, with low back pain, menorrhagia, suspected peptic ulcer, and varicose veins. MAIN OUTCOME MEASURES: Postal questionnaire including the PGI, SF-36 health survey, and clinically derived condition specific measures of disease severity. RESULTS: Test-retest reliability was satisfactory for group comparisons (intraclass correlation coefficient 0.65). Validity was confirmed by the observed association of the PGI with the SF-36, condition specific instruments, and sociodemographic variables. For low back pain, the PGI and the SF-36 pain scale were found to be most responsive to clinical change. For patients with menorrhagia and suspected peptic ulcer, only the condition specific instruments detected larger changes than the PGI. CONCLUSIONS: It is possible to develop a patient generated index of quality of life that not only assesses the extent to which patients' expectations are matched by reality but also satisfies criteria of reliability and responsiveness to change. Further work is required to make the PGI more acceptable and meaningful to patients, but it is believed that it offers an exciting new approach to the evaluation of medical care.

Family Practice↗

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. DESIGN: Single-centre randomised trial. SETTING: A teaching hospital in the United Kingdom. PARTICIPANTS: One hundred and ninety-seven women seeking specialist treatment of heavy menstrual loss for the first time and willing to accept either treatment. INTERVENTIONS: 1. Medical treatments not previously used by the women prescribed by experienced gynaecologists in standard doses and timings for a minimum of three cycles (n = 94), and 2. transcervical resection of the endometrium performed under general anaesthesia five weeks after goserelin preparation (n = 93). MAIN OUTCOME MEASURES: Treatment satisfaction and acceptability, relief of symptoms, change in haemoglobin, and improvement in health related quality of life, all after four months. RESULTS: Women allocated transcervical resection were more likely to be totally or generally satisfied (76% versus 27%, P < 0.001), to find the treatment acceptable (93% versus 36%, P < 0.001), and willing to have the treatment again (93% versus 31%, P < 0.001). Although pain and bleeding were significantly reduced by medical treatment this was modest in comparison with transcervical resection (P < 0.001). Haemoglobin levels were significantly increased only following transcervical resection. Short form 36 scores were also improved in both arms, although only transcervical resection returned them to normal values. CONCLUSIONS: Medical treatment was less effective than transcervical resection of the endometrium, irrespective of previous treatment or type of medical management. Early hysteroscopic endometrial surgery should be considered by such woman with the choice made by the woman after a full discussion of the advantages and disadvantages of all the options.

Adult↗

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. DESIGN: Randomised controlled comparison of two clinical trial designs with subsequent follow up of the cohorts of women generated. PARTICIPANTS: Women attending a general gynaecology clinic for the first time because of heavy menstrual bleeding. INTERVENTIONS: Partially randomised patient preference clinical trial design and conventional randomised controlled design. MAIN OUTCOME MEASURES: Overall participation; participation in randomised clinical trial of medical management compared with transcervical surgical resection of the endometrium; prognostic characteristics (socio-demographic and Short Form 36) of clinical trial groups; outcomes (clinical and Short Form 36) of clinical trial groups. RESULTS: Overall, more women participated in the partially randomised patient preference design (130/135 vs 97/138; difference 27%, 95% CI 18% to 34%) but there was no difference in the numbers who agreed to be randomised (90/135 vs 97/138; difference-3%, 95% CI-15% to 7%). Women who chose medical management tended to have better general health, to be less restricted by their menstrual problems, with fewer having been previously treated by their general practitioner. Those who chose transcervical resection of the endometrium had all tried medical management and had higher bleeding scores. Follow up satisfactions and acceptability rates, and Short Form 36 scores were highest after transcervical resection of the endometrium, whether chosen or randomised. Acceptability and a desire to continue the same treatment was greater among those who chose medical management than those randomly allocated it. CONCLUSIONS: Use of the partially randomised patient preference design did not affect recruitment to the randomised controlled trial suggesting that a conventionally designed trial would not be biased by motivational factors in this context. Data from the preference groups informed the generalisability of the results but did tend to confirm conclusions that anyway reasonably followed from the randomised controlled trial. The extra resource implications of using the partially randomised patient preference design were significant reflecting the additional 40% who participated and the extra analyses entailed.

Adult↗

Measuring health-related quality of life outcomes in women with endometriosis--results of the Gynaecology Audit Project in Scotland.

The clinical management of endometriosis was addressed within the recent Gynaecology Audit Project in Scotland. The impact of endometriosis and its treatment on women's health-related quality of life was examined using a condition-specific measure and a general measure, the Short Form 36 health survey (SF-36). Postal questionnaires containing the health-related quality of life measures were sent to 273 women at diagnosis and six months later. The measurement properties, including the reliability, validity and responsiveness, of the measures were examined. The condition-specific questions and the SF-36 had a high level of reliability. The validity of the condition-specific scores was demonstrated by their high correlation with the SF-36 which is a well-validated measure. Furthermore, the condition-specific scores were related to clinicians' assessment of disease severity and the need for further treatment. At the six month follow-up, changes in scores conformed to expected hypotheses, demonstrating the responsiveness of both measures. As a general measure, the SF-36 appeared to reflect the effects of both the condition of interest (i.e. endometriosis) and other conditions affecting health at the time of measurement (i.e. treatment side effects). The condition-specific measure was more responsive than the SF-36 to the changes in pain symptoms which resulted from active treatment. A condition-specific questionnaire, together with a general measure such as the SF-36 health survey, can provide a reliable, valid and responsive package of measures for assessing health-related quality of life in women with endometriosis. Such measures should be used alongside clinical measures of outcome to assess the effectiveness of different treatment strategies for endometriosis. A similar approach combining general and specific instruments would be useful in medical audits of other conditions.

Adolescent↗

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.

Adult↗

Developing a condition-specific measure of health for patients with dyspepsia and ulcer-related symptoms.

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 outpatient 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.

Adult↗

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 patient's 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.

Adolescent↗

Measuring sexual functioning in premenopausal women.

OBJECTIVE: To assess the validity and reliability of a measure of sexual function for premenopausal women. DESIGN: A self-administered sexual function questionnaire, derived from the Sabbatsberg Sexual Self-Rating Scale, and other health measures were given to women who were randomly sampled from the community health index. SUBJECTS: One hundred and forty-eight premenopausal women aged between 45 and 49 years. MAIN OUTCOME MEASURES: The content validity, internal consistency and construct validity of the revised sexual rating scale. RESULTS: One hundred and thirty-seven women (92%) responded to the main questionnaire and 89 (60%) completed the sexual rating scale, which possessed a high level of internal consistency; scores on the sexual rating scale, which possessed a high level of internal consistency; scores on the sexual ratings scale had small to moderate correlations with the measures of health, two of which (depression and role limitations attributable to emotional problems) were sufficient to explain 25% of the variation in the sexual functioning scores. CONCLUSION: Questions derived from the Sabbatsberg sexual self-rating scale have been used to construct a simple, acceptable, valid and reliable measure of sexual functioning for women in the 45 to 49 years of age group. Such a measure could be widely used as an adjunct to clinical and more general measures of health in order to assess the impact of interventions on sexual functioning within clinical trials.

Female↗

Patients' perception of health on renal replacement therapy: evaluation using a new instrument.

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)

Adolescent↗

Developing a valid and reliable measure of health outcome for patients with low back pain.

OBJECTIVE: The authors developed and validated a measure of health outcome for patients with low back pain. RESULTS: A questionnaire was developed incorporating the type of questions asked when taking a clinical history. After testing on a sample of 568 patients, three questions were discarded from the questionnaire. The final questionnaire was found to be reliable and valid in the sense that patients' scores correlated highly with their scores on a general health profile and with GP perceptions of severity. Health status in patients with low back pain was significantly impaired when compared with the general population. CONCLUSION: A clinically based questionnaire, together with a general measure of health, can provide a valid and reliable package for the routine assessment of perceived health in patients with low back pain.

Activities of Daily Living↗

A new approach to the measurement of quality of life. The Patient-Generated Index.

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.

Activities of Daily Living↗

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 Cronbach's 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 patient's 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.

Adolescent↗

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 year's 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 instrument's 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.

Adolescent↗

The SF36 health survey questionnaire: an outcome measure suitable for routine use within the NHS?

OBJECTIVE: To assess the validity, reliability, and acceptability of the short form 36 (SF 36) health survey questionnaire (a shortened version of a battery of 149 health status questions) as a measure of patient outcome in a broad sample of patients suffering from four common clinical conditions. DESIGN: Postal questionnaire, followed up by two reminders at two week intervals. SETTING: Clinics and four training practices in north east Scotland. SUBJECTS: Over 1700 patients aged 16-86 with one of four conditions--low back pain, menorrhagia, suspected peptic ulcer, or varicose veins--and a comparison sample of 900 members of the general population. MAIN OUTCOME MEASURES: The eight scales within the SF36 health profile. RESULTS: The response rate exceeded 75% in the patient population (1310 respondents). The SF36 satisfied rigorous psychometric criteria for validity and internal consistency. Clinical validity was shown by the distinctive profiles generated for each condition, each of which differed from that in the general population in a predictable manner. Furthermore, SF36 scores were lower in referred patients than in patients not referred and were closely related to general practitioners' perceptions of severity. CONCLUSIONS: These results provide support for the SF36 as a potential measure of patient outcome within the NHS. The SF36 seems acceptable to patients, internally consistent, and a valid measure of the health status of a wide range of patients. Before it can be used in the new health service, however, its sensitivity to changes in health status over time must also be tested.

Adolescent↗

Towards measurement of outcome for patients with varicose veins.

OBJECTIVE: To develop a valid and reliable outcome measure for patients with varicose veins. DESIGN: Postal questionnaire survey of patients with varicose veins. SETTING: Surgical outpatient departments and training general practices in Grampian region. SUBJECTS: 373 patients, 287 of whom had just been referred to hospital for their varicose veins and 86 who had just consulted a general practitioner for this condition and, for comparison, a random sample of 900 members of the general population. MAIN MEASURES: Content validity, internal consistency, and criterion validity. RESULTS: 281(76%) patients (mean age 45.8; 76% female) and 542(60%) of the general population (mean age 47.9; 54% female) responded. The questionnaire had good internal consistency as measured by item-total correlations. Factor analysis identified four important health factors: pain and dysfunction, cosmetic appearance, extent of varicosity and complications. The validity of the questionnaire was demonstrated by a high correlation with the SF-36 health profile, which is a general measure of patients' health. The perceived health of patients with varicose veins, as measured by the SF-36, was significantly lower than that of the sample of the general population adjusted for age and a lower proportion of women. CONCLUSION: A clinically derived questionnaire can provide a valid and reliable tool to assess the perceived health of patients with varicose veins. IMPLICATIONS: The questionnaire may be used to justify surgical treatment of varicose veins.

Adult↗

Problems in using health survey questionnaires in older patients with physical disabilities. Can proxies be used to complete the SF-36?

BACKGROUND: The SF-36 Health Survey questionnaire has been proposed as a generic measure of health outcome. However, poor rates of return and high levels of missing data have been found in elderly subjects and, even with face-to-face interview, reliability and validity may still be disappointing, particularly in cognitively impaired patients. These patients may be the very patients whose quality of life is most affected by their illness and their exclusion will lead to biased evaluation of health status. A possible alternative to total exclusion is the use of a proxy to answer on the patient's behalf, but few studies of older people have systematically studied patient-proxy agreement. OBJECTIVE: To compare the agreement between patients, lay and professional proxies when assessing the health status of patients with the SF-36. METHODS: The SF-36 was administered by interview to 164 cognitively normal, elderly patients (Mini-mental State Examination 24 or more) referred for physical rehabilitation. The SF-36 was also completed by a patient-designated lay proxy (by post) and a professional proxy. Agreement between proxies and patients was measured by intraclass correlation coefficients (ICCs), and a bias index. RESULTS: Professional proxies were better able to predict the patients' responses than were the lay proxies. Criterion levels of agreement (ICC 0.4 or over) were attained for four of the eight dimensions of the SF-36 by professional proxies, but for only one dimension by lay proxies. In professional proxies, the magnitude of the bias was absent or slight (<0.2) for six of the eight dimensions of the SF-36 with a small (0.2-0.49) negative bias for the other two. Lay proxies showed a negative bias (i.e. they reported poorer function than did the patients themselves) for seven of the eight dimensions of the SF-36 (small in two and moderate (0.5-0.79) in five). CONCLUSIONS: For group comparisons using the SF-36, professional proxies might be considered when patients cannot answer reliably for themselves. However, in the present study, lay proxy performance on a postal questionnaire showed a strong tendency to negative bias. Further research is required to define the limitations and potentials of proxy completion of health status questionnaires.

Aged↗