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It has been suggested that the quality of clinical trials should be assessed by blinded raters to limit the risk of introducing bias into meta-analyses and systematic reviews, and into the peer-review process. There is very little evidence in the literature to substantiate this. This study describes the development of an instrument to assess the quality of reports of randomized clinical trials (RCTs) in pain research and its use to determine the effect of rater blinding on the assessments of quality. A multidisciplinary panel of six judges produced an initial version of the instrument. Fourteen raters from three different backgrounds assessed the quality of 36 research reports in pain research, selected from three different samples. Seven were allocated randomly to perform the assessments under blind conditions. The final version of the instrument included three items. These items were scored consistently by all the raters regardless of background and could discriminate between reports from the different samples. Blind assessments produced significantly lower and more consistent scores than open assessments. The implications of this finding for systematic reviews, meta-analytic research and the peer-review process are discussed.

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 régimen 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.

This review outlines the possible uses of subjective health status measures in the evaluation of medical treatment, and possible limitations and pitfalls that potential users of such measures must be aware. Whilst much has been written about the requirements of measures in terms of reliability, validity and responsiveness, many existing measures which have gained widespread use have serious shortcomings. In this paper, the limitations of some existing questionnaires are outlined. It is argued that whilst outcomes measurement has the promise to positively influence medical care, done without due consideration of its limitations and weaknesses it could lead to inaccurate or inappropriate data. In the current climate, in which health outcomes data is viewed as central to monitoring and evaluation, inappropriate or unconsidered use of measures could have drastic effects.

Our objective was to assess the sensitivity to change over time of three methods of assessing pain. We conducted a comparison of the sensitivity to change of three pain assessment measures in a double blind, double dummy parallel group study evaluating the efficacy of one of two doses of oral bromfenac and one of two doses of sublingual buprenorphine. Our subject pool consisted of 75 patients following general surgical and orthopaedic procedures. Pain intensity was measured by the affective, sensory and evaluative dimensions of the McGill Pain Questionnaire together with total score and word score, a 10 cm Visual Analogue Scale and by a four word scale. Effect size calculations indicated considerable variation in the sensitivity of the instruments to change. However, despite variation in the size of effect indicated by different measures, there was consistent agreement as to the most effective treatment regimen. This study suggests that simple measures of pain are sensitive to change and are worthwhile indicators of the impact of an intervention upon acute pain, although some care is needed in interpreting results from such instruments. More complex forms of assessment, such as the calculation of the MPQ sub-scales may not add anything to such data.

Parkinson's disease is a common degenerative neurological condition. A number of general health status measures exist but these may not address areas salient to specific diseases. We report here the development and validation of a short 39 item health status questionnaire for use in Parkinson's disease. Questionnaire items, generated from in-depth interviews with people with Parkinson's disease, were developed into a 65 item questionnaire. Data from a postal survey using the 65 item questionnaire were statistically analysed to produce a shorter questionnaire with 39 items and eight scales addressing different dimensions of Parkinson's disease. A second postal survey was conducted in order to assess the reliability and validity of the new 39 item questionnaire. The final questionnaire, referred to here as the 39 item Parkinson's Disease Questionnaire (PDQ-39), proved to have satisfactory internal and test-retest reliability, and construct validity in relation to other measures, reported by respondents with Parkinson's disease.

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.

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.

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.

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.

The importance of patient-based assessments of outcomes of care in RA is increasingly recognized. There are a number of methods of gaining such data. One method is to request patients to assess change in health status by means of transition questions. This is considered advantageous to other methods because is directly addresses perceptions of change over time and is short and simple. One hundred patients with RA completed a range of clinical, laboratory and health status assessments on two occasions 3 months apart. On the second occasion they also completed a transition question. Results show the question to be valid and to correlate with a number of different changes obtained from assessments. Psychological mood did not appear to influence transition judgements. A small minority of patients experienced changes for specific dimensions of health status in the opposite direction of the transition item. Transition judgements may have an important role in evaluation studies and audit.

In recent years much attention has been paid to the development of measures of subjective health status yet, although statistical criteria of reliability and validity have been quite rigourously tested, there has been little consideration of the different theories of disability which underlie the design. The sociology of disability may illuminate such tacit theories. It is suggested that the development of health status questionnaires has not been one of simple rational accumulation in response to methodological advances. Through an examination of the content of health assessment questionnaires, four distinct models of disability are identified. These are shown to influence not only the focus of the content and phrasing of the questions but also, crucially, the way that they perform and how responsive they are to change. The models (the functional, subjective distress, comparative and dependence) are illustrated and discussed in terms related to research design.

Objectives: To gain population norms for the short form 36 health survey questionnaire (SF36) in a large community sample and to explore the questionnaire's internal consistency and validity., Design: Postal survey by using a booklet containing the SF36 and several other items concerned with lifestyles and illness., Setting: The sample was drawn from computerised registers of the family health services authorities for Berkshire, Buckinghamshire, Northamptonshire, and Oxfordshire., Sample: 13,042 randomly selected subjects aged 18-64 years., Main Outcome Measures: Scores for the eight health dimensions of the SF36., Results: The survey achieved a response rate of 72% (n = 9332). Internal consistency of the different dimensions of the questionnaire was high. Normative data broken down by age, sex, and social class were consistent with those from previous studies., Conclusions: The SF36 is a potentially valuable tool in medical research. The normative data provided here may further facilitate its validation and use.

We carried out a study to compare the sensitivity to change of disease specific compared with more generic health status instruments in relation to rheumatoid arthritis (RA). A sample of 102 patients was recruited and assessed by means of 4 health status instruments and standard rheumatological measures on 3 occasions separated by 3 monthly intervals. Sensitivity to change for mobility, activities of daily living, household, pain, emotions and social dimensions were calculated. For some dimensions disease specific health status instruments performed less well. However overall there was no evidence of consistent differences between the 2 approaches. We conclude that generic instruments have a role in the assessment of RA.

As an alternative to the calculation of change scores for health status questionnaires used in clinical trials or longitudinal studies, transitional questions have been developed for patients to assess changes directly themselves. Here the original Health Assessment Questionnaire (HAQ) is compared with a modified version of the HAQ (MHAQ) which contains transition questions used at follow up. These, together with a set of standard rheumatological tests, were all completed by 100 patients with rheumatoid arthritis on two occasions, three months apart. Change scores were calculated for the HAQ and for the clinical measures and compared with the MHAQ. The results were strikingly in favour of encouraging patients to assess their own degree of change through the use of transition questions in the MHAQ.

Objective: To assess the sensitivity to change over time of four health status instruments in relation to patients with rheumatoid arthritis., Design: Observational three month study of four self assessed instruments (arthritis impact measurement scales (AIMS), health assessment questionnaire (HAQ), Nottingham health profile (NHP), functional limitations profile (FLP))., Setting: One rheumatology unit., Patients: 101 patients with definite or classic rheumatoid arthritis., Main Measures: Change scores for dimensions of instruments, as determined by effect size (mean change in score/baseline standard deviation of variable) and conventional rheumatological measures, at baseline and after three months., Results: Change scores for comparable dimensions (mobility, activities of daily living, household, pain, mood or emotion, and social scales) of the instruments were compared among 30 patients who considered their health status to have improved over three months. For all dimensions of health status the magnitude of change varied considerably according to the instrument. Maximum range in effect size was for social scales (AIMS 0.06, NHP 0.24, FLP 0.60). No single instrument seemed consistently to show the most change over all dimensions., Conclusion: Selection of health status instruments for audit or evaluation may have a considerable impact on the pattern of results obtained, and the "responsiveness" of such scales should be as carefully examined as their reliability and acceptability when selecting outcome measures.

Seventy-three patients with RA were assessed by means of the Nottingham Health Profile (NHP), the Arthritis Impact Measurement Scales (AIMS) and a number of clinical measures. Patients with RA scored higher than controls on the NHP scales for energy, pain, mobility and sleep. Energy, pain, mobility and emotions scales of the NHP correlate significantly with other measures such as clinical assessments, matching scales of the AIMS and the Beck Depression Inventory, indicating satisfactory validity for the instrument with RA. Five of the six scales of the NHP are stable on retesting. The social scale of the NHP on the other hand does not correlate with the matching instrument of the AIMS and is relatively unstable over time. Measurement properties of generic health status instruments such as the NHP will require serious attention as they are increasingly used in evaluation studies.

Fifty-six patients with rheumatoid arthritis (RA) were assessed on two occasions three months apart. They completed two health status instruments--the Arthritis Impact Measurement Scales (AIMS) and the Nottingham Health Profile (NHP)--and the Beck Depression Inventory. In addition, clinical and serological data were gathered in order to calculate severity of disease according to the Mallya and Mace index. Health status instruments and the severity of disease index showed agreement in the assessment of mobility; similar agreement was found for different assessments of emotions. However, the two instruments provided social interaction scores with little agreement either cross-sectionally or in terms of change over time. It is argued that the generic NHP may be a valid instrument as an outcome measure in RA but the NHP and AIMS assess different aspects of social interaction. Care is needed in the selection of outcome measures to evaluate interventions.

There is currently much interest in the measurement of self reported health status. A number of health status measures have been designed. However, such questionnaires are often long and complicated, or are disease specific. The most famous generic British health status instrument is the Nottingham Health Profile (NHP) which is a short questionnaire designed for ease of completion. However, this paper addresses a number of related issues concerning the weights attached to particular items on this questionnaire. It is argued that the weighting of items by Thurstone's method of paired comparisons is inappropriate and can lead to logically inconsistent results.

The results of two commonly used instruments for measuring health status were compared in patients with chronic illness. The Nottingham health profile (NHP) is a measure of perceived health, while the general health questionnaire (GHQ) is a measure of non-psychotic psychiatric disturbance. The questionnaires were completed by patients suffering either rheumatoid arthritis or migraine. The results provide evidence that, despite some specific problems in the measurement of pain and emotional reactions, the NHP and GHQ may be used to assess the impact of illness upon sufferers' lives, not only in severely disabling disorders such as rheumatoid arthritis, but in health problems such as migraine which have often been considered as relatively minor ailments.

This paper is a report of the results gained from the administration of a health status questionnaire, the Nottingham Health Profile (NHP), on a sample of migraine sufferers. It is argued that chronic migraine suffering is an illness that has implications for perceived health status, and that the NHP is sufficiently sensitive to detect this. The results suggest that scores on the domains of Energy, Sleep and Social Relationships are associated with respondents' mood state as measured on an established psychiatric screening device, the General Health Questionnaire (GHQ-30). It is argued that the NHP has important uses as a survey measure of perceived ill-health in populations, and as an indicator of psychiatric morbidity.

A recent criticism of the Nottingham Health Profile (NHP) claimed it was an insensitive instrument for use in population surveys, because its modal response was zero, and domains measured by the instrument are insufficiently distinct. It is argued here that the NHP was designed specifically to uncover the chronically ill in populations and, further, research undertaken here indicates that the instrument is sufficiently sensitive to be successful in permitting variations within and between illness groups to be determined. However, the domains of mobility and pain, as measured by the instrument, are found to be confounded.