Stephen J. Walters

Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D.

Background: The SF-6D and EQ-5D are both preference-based measures of health. Empirical work is required to determine what the smallest change is in utility scores that can be regarded as important and whether this change in utility value is constant across measures and conditions. Objectives: To use distribution and anchor-based methods to determine and compare the minimally important difference (MID) for the SF-6D and EQ-5D for various datasets. Methods: The SF-6D is scored on a 0.29–1.00 scale and the EQ-5D on a −0.59–1.00 scale, with a score of 1.00 on both, indicating ‘full health’. Patients were followed for a period of time, then asked, using question 2 of the SF-36 as our anchor, if their general health is much better (5), somewhat better (4), stayed the same (3), somewhat worse (2) or much worse (1) compared to the last time they were assessed. We considered patients whose global rating score was 4 or 2 as having experienced some change equivalent to the MID. This paper describes and compares the MID and standardised response mean (SRM) for the SF-6D and EQ-5D from eight longitudinal studies in 11 patient groups that used both instruments. Results: From the 11 reviewed studies, the MID for the SF-6D ranged from 0.011 to 0.097, mean 0.041. The corresponding SRMs ranged from 0.12 to 0.87, mean 0.39 and were mainly in the ‘small to moderate’ range using Cohen’s criteria, supporting the MID results. The mean MID for the EQ-5D was 0.074 (range −0.011–0.140) and the SRMs ranged from −0.05 to 0.43, mean 0.24. The mean MID for the EQ-5D was almost double that of the mean MID for the SF-6D. Conclusions: There is evidence that the MID for these two utility measures are not equal and differ in absolute values. The EQ-5D scale has approximately twice the range of the SF-6D scale. Therefore, the estimates of the MID for each scale appear to be proportionally equivalent in the context of the range of utility scores for each scale. Further empirical work is required to see whether or not this holds true for other utility measures, patient groups and populations.

Psychometric scores and persistence of irritable bowel after infectious diarrhoea.

BACKGROUND Although previous studies have shown that psychological disturbances are frequently associated with the irritable bowel syndrome (IBS), the relation was not necessarily cause and effect. The development of chronic bowel symptoms resembling IBS after an episode of acute gastroenteritis has allowed us to examine prospectively the role of psychological factors. METHODS 75 patients with acute gastroenteritis completed a series of psychometric tests soon after admission to hospital. Of these, 22 had persistent symptoms compatible with IBS after the acute illness, and in 20 of these the symptoms were still present at six months. FINDINGS At the time of their initial illness, patients who subsequently developed IBS symptoms had higher scores for anxiety, depression, somatisation, and neurotic trait than those who returned to normal bowel function. The psychometric scores had not changed when remeasured three months after the acute illness. Lactose malabsorption was not an important factor. INTERPRETATION These results support the hypothesis that psychological factors are important in IBS.

The York acupuncture safety study: prospective survey of 34 000 treatments by traditional acupuncturists

Recent reports have highlighted the importance of having good evidence on the safety of acupuncture. 1 2 Sound evidence on the risks associated with acupuncture is, however, scarce.3 Our primary aim, therefore, was to describe the type and frequency of adverse events after acupuncture. A secondary aim was to examine mild transient reactions associated with acupuncture, some of which may indicate a positive response to treatment. The study involved a prospective postal audit of treatments undertaken during a four week period in 2000. All 1848 professional acupuncturists who were members of the British Acupuncture Council and were practising in the United Kingdom were invited to record details of adverse events and mild transient reactions after treatment. Standardised self report forms were used. Participating practitioners also provided information on themselves, including age, sex, length of training, and years of practice. To have a …

Using the SF-36 and Euroqol on an elderly population.

An important methodological issue in measuring health-related quality of life is whether instruments such as SF-36 and EQ can be used on an elderly population. This paper aims to test the completion, reliability and validity of the SF-36 and Euroqol on an elderly female population, and to compare them with the OPCS Disability Survey. Three hundred and eighty women aged 75 and over participated in a randomized controlled trial of the use of clodronate provided the sample. As part of the trial, patients were asked to complete the UK SF-36 and Euroqol, and the OPCS disability survey instrument administered by interview in a hospital clinic at baseline. A random subsample of respondents were retested six months later. The SF-36 achieved poorer levels of completion by dimension (68.1%–88.9%) than the OPCS (99.2%) and Euroqol (84%–93.5%) instruments. There were no major floor effects in the distribution of scores, except for the role dimensions of SF-36. Correlation between test-retest were significant for all instruments, but lower for the role dimensions and social functioning of SF-36, and these dimensions also had 95% Cls for the mean differences in excess of 10 points. There was substantial agreement between the three instruments, and evidence for their construct validity against age and recent use of health services. The sensitivities of the instruments were tested through hypothetical changes in health status. There was some evidence of greater sensitivity to lower levels of morbidity in the SF-36. Where brevity is required and the health changes are expected to be substantial, then EQ may be sufficient. For greater sensitivity SF-36 seems to have an advantage, however lower completion rates and problems with consistency suggest it requires adaptation. One solution would be to use interviewer administration. Another would be to change the SF-36 to make it more suitable for use in elderly people, although this may reduce its usefulness as a generic instrument.

Costs and effectiveness of community postnatal support workers: randomised controlled trial.

Abstract Objectives: To establish the relative cost effectiveness of postnatal support in the community in addition to the usual care provided by community midwives. Design: Randomised controlled trial with six month follow up. Setting: Recruitment in a university teaching hospital and care provided in womens homes. Participants: 623 postnatal women allocated at random to intervention (311) or control (312) group. Intervention: Up to 10 home visits in the first postnatal month of up to three hours duration by a community postnatal support worker. Main outcome measure: General health status as measured by the SF-36 and risk of postnatal depression. Breast feeding rates, satisfaction with care, use of services, and personal costs. Results: At six weeks there was no significant improvement in health status among the women in the intervention group. At six weeks the mean total NHS costs were £635 for the intervention group and £456 for the control group (P=0.001). At six months figures were £815 and £639 (P=0.001). There were no differences between the groups in use of social services or personal costs. The women in the intervention group were very satisfied with the support worker visits. Conclusions: There was no health benefit of additional home visits by community postnatal support workers compared with traditional community midwifery visiting as measured by the SF-36. There were no savings to the NHS over six months after the introduction of the community postnatal support worker service.

Clinical effectiveness of health visitor training in psychologically informed approaches for depression in postnatal women: pragmatic cluster randomised trial in primary care

Objective To evaluate benefits for postnatal women of two psychologically informed interventions by health visitors. Design Prospective cluster trial randomised by general practice, with 18 month follow-up. Setting 101 general practices in Trent, England. Participants 2749 women allocated to intervention, 1335 to control. Intervention Health visitors (n=89 63 clusters) were trained to identify depressive symptoms at six to eight weeks postnatally using the Edinburgh postnatal depression scale (EPDS) and clinical assessment and also trained in providing psychologically informed sessions based on cognitive behavioural or person centred principles for an hour a week for eight weeks. Health visitors in the control group (n=49 38 clusters) provided usual care. Main outcome measures Score ≥12 on the Edinburgh postnatal depression scale at six months. Secondary outcomes were mean Edinburgh postnatal depression scale, clinical outcomes in routine evaluation-outcome measure (CORE-OM), state-trait anxiety inventory (STAI), SF-12, and parenting stress index short form (PSI-SF) scores at six, 12, 18 months. Results 4084 eligible women consented and 595 women had a six week EPDS score ≥12. Of these, 418 had EPDS scores available at six weeks and six months. At six months, 34% women (93/271) in the intervention group and 46% (67/147) in the control group had an EPDS score ≥12. The odds ratio for score ≥12 at six months was 0.62 (95% confidence interval 0.40 to 0.97, P=0.036) for women in the intervention group compared with women in the control group. After adjustment for covariates, the odds ratio was 0.60 (0.38 to 0.95, P=0.028). At six months, 12.4% (234/1880) of all women in the intervention group and 16.7% (166/995) of all women in the control group had scores ≥12 (0.67, 0.51 to 0.87, P=0.003). Benefit for women in the intervention group with a six week EPDS score ≥12 and for all women was maintained at 12 months postnatally. There was no differential benefit for either psychological approach over the other. Conclusion Training health visitors to assess women, identify symptoms of postnatal depression, and deliver psychologically informed sessions was clinically effective at six and 12 months postnatally compared with usual care. Trial registration ISRCTN92195776.

Cost effectiveness of community leg ulcer clinics: randomised controlled trial

Abstract Objectives: To establish the relative cost effectiveness of community leg ulcer clinics that use four layer compression bandaging versus usual care provided by district nurses. Design: Randomised controlled trial with 1 year of follow up. Setting: Eight community based research clinics in four trusts in Trent. Subjects: 233 patients with venous leg ulcers allocated at random to intervention (120) or control (113) group. Interventions: Weekly treatment with four layer bandaging in a leg ulcer clinic (clinic group) or usual care at home by the district nursing service (control group). Main outcome measures: Time to complete ulcer healing, patient health status, and recurrence of ulcers. Satisfaction with care, use of services, and personal costs were also monitored. Results: The ulcers of patients in the clinic group tended to heal sooner than those in the control group over the whole 12 month follow up (log rank P=0.03). At 12 weeks, 34% of patients in the clinic group were healed compared with 24% in the control. The crude initial healing rate of ulcers in intervention compared with control patients was 1.45 (95% confidence interval 1.04 to 2.03). No significant differences were found between the groups in health status. Mean total NHS costs were £878.06 per year for the clinic group and £859.34 for the control (P=0.89). Conclusions: Community based leg ulcer clinics with trained nurses using four layer bandaging is more effective than traditional home based treatment. This benefit is achieved at a small additional cost and could be delivered at reduced cost if certain service configurations were used. Key messages Leg ulcer clinics based in the community using four layer compression bandaging can be more clinically effective than usual care provided by the district nursing service Community based leg ulcer clinics could be provided more cost effectively than usual home based care for venous leg ulcers Recurrence of venous leg ulcers is an important variable that should be measured in future trials of venous leg ulcer care It is difficult to measure improvements in health related quality of life among people with venous leg ulcers

Health-Related Quality of Life and Cost Impact of Irritable Bowel Syndrome in a UK Primary Care Setting

AbstractObjectives: To identify the impact of irritable bowel syndrome (IBS) on health-related quality of life (HR-QOL), time off work and the utilisation and cost of health services. Design: A case-control study was undertaken matching patients with IBS and controls. Quality-of-life information was collected using the Medical Outcomes Study 36-item Short Form (SF-36) health survey, EuroQOL instrument (EQ-5D) and IBS Quality-of-Life (IBS-QOL) instruments. Data on time off work was also collected. National Health Service (NHS) resource use in primary and secondary care was estimated by review of general practitioner (GP) and hospital records over a 12-month period. Setting: Recruitment was from six GPs’ surgeries in the Trent Region of the United Kingdom. Participants: 161 patients with IBS, as defined by the Rome Criteria I were recruited. These were compared with 213 controls matched for age, sex and social characteristics. Main outcome measures: SF-36 and EQ-5D scores; mean number of days off work; mean NHS costs per person during the 12-month study period. Results: Patients with IBS had considerably lower HR-QOL than controls. They scored worse in all dimensions of the SF-36 and the EQ-5D and they had more time off work. On average patients with IBS cost the NHS £123 (95% confidence interval: £35 to £221, 1999 values) more per year than individuals in the control group (p = 0.04). Conclusions: IBS affects patients through reduced quality of life, more time off work and greater healthcare utilisation than a control group of patients without IBS. The difference in quality of life was pronounced and unusual in that it was influential in every dimension of both the SF-36 and the EQ-5D.

A prospective survey of adverse events and treatment reactions following 34,000 consultations with professional acupuncturists.

The paper describes the type and frequency of adverse events and transient reactions following consultations with professional acupuncturists. In a postal survey, involving 1848 professional acupuncturists, all of whom were members of the British Acupuncture Council and practising in the UK, details of adverse events and transient reactions following treatment were recorded on standardised self-report forms. A sample size of 30,000 treatments was sought, and piloting indicated that a four-week period was required. Practitioners also provided information on themselves, including age, sex, length of training and years of practice. A total of 574 practitioners responded, 31% of the total population. These practitioners reported on adverse events and transient reactions associated with 34,407 treatments. No serious adverse events were reported, where these were defined as requiring hospital admission, prolonging hospital stays, permanently disabling, or resulting in death (95% CI: 0 to 1.1 per 10,000 treatments). A total of 43 significant minor adverse events were reported, a rate of 1.3 per 1,000 treatments (95% CI: 0.9 to 1.7). These included severe nausea and actual fainting (12), unexpected, severe and prolonged aggravation of symptoms (7), prolonged and unacceptable pain and bruising (5) and psychological and emotional reactions (4). There were three avoidable events: two patients had needles left in by mistake, and one patient had moxa burns to the skin, also caused by practitioner error. The acupuncturists also recorded 10,920 mild transient reactions occurring in 5136 treatments, 15% (95% CI: 14.6 to 15.3) of the 34,407 total. In terms of local reactions, there were reports of mild bruising (1.7%), pain (1.2%) and bleeding (0.4%). Practitioners reported that patients experienced an aggravation of existing symptoms after 2.8% of treatments. The most common mild transient reactions to treatment were feeling relaxed (11.9%) and feeling energised (6.6%). In this prospective survey of 34,407 treatments, practitioners reported no serious adverse events. This conclusion was based on data collected from one in three members of the British Acupuncture Council. Given that the whole membership delivers between one and a half and two million treatments a year, this is important evidence on public health and safety. When compared with medication routinely prescribed in primary care, the results suggest that acupuncture is a relatively safe treatment modality.

Patient reports of adverse events associated with acupuncture treatment: a prospective national survey

Objective: The primary aim was to establish from acupuncture patients the type and frequency of adverse events they experienced and attributed to their treatment. Secondary aims included the measurement of patient reported adverse consequences arising from advice received about conventional/prescribed medication or from delayed conventional diagnosis and treatment. Methods: Postal survey of prospectively identified acupuncture patients. One in three members of the British Acupuncture Council (n = 638) invited consecutive patients to participate in the survey. Participating patients gave baseline data and consented to direct follow up by the researchers at 3 months. A structured questionnaire was used to collect data on perceived adverse events. Results: 9408 patients gave baseline information and consent and 6348 (67%) completed 3 month questionnaires. Responders were not dissimilar to non-responders for all known characteristics. 682 patients reported at least one adverse event over 3 months, a rate of 107 per 1000 patients (95% CI 100 to 115). Three patients reported a serious adverse event. The most common events reported were severe tiredness and exhaustion, pain at the site of needling, and headache. Patients receiving acupuncture treatment that was not funded by the NHS and patients not in contact with a GP or hospital specialist were less likely to report adverse events (odds ratios 0.59 and 0.66, respectively). 199 (3%) of responding patients reported receiving advice about conventional/prescribed medication, six of whom reported adverse consequences after taking the advice. Two patients reported delayed conventional treatment. Conclusion: Patients report a range of adverse events but these do not prevent most patients seeking further acupuncture. This large scale survey supports existing evidence that acupuncture is a relatively safe intervention when practised by regulated practitioners.