The effectiveness and cost-effectiveness of minimal access surgery amongst people with gastro-oesophageal reflux disease - a UK collaborative study. The REFLUX trial.

OBJECTIVES: To evaluate the clinical effectiveness, cost-effectiveness and safety of a policy of relatively early laparoscopic surgery compared with continued medical management amongst people with gastro-oesophageal reflux disease (GORD) judged suitable for both policies. DESIGN: Relative clinical effectiveness was assessed by a randomised trial (with parallel non-randomised preference groups) comparing a laparoscopic surgery-based policy with a continued medical management policy. The economic evaluation compared the cost-effectiveness of the two management policies in order to identify the most efficient provision of future care and describe the resource impact that various policies for fundoplication would have on the NHS. SETTING: A total of 21 hospitals throughout the UK with a local partnership between surgeon(s) and gastroenterologist(s) who shared the secondary care of patients with GORD. PARTICIPANTS: The 810 participants, who were identified retrospectively or prospectively via their participating clinicians, had both documented evidence of GORD (endoscopy and/or manometry/24-hour pH monitoring) and symptoms for longer than 12 months. In addition, the recruiting clinician(s) was clinically uncertain about which management policy was best. INTERVENTION: Of the 810 eligible patients who consented to participate, 357 were recruited to the randomised arm of the trial (178 allocated to surgical management, 179 allocated to continued, but optimised, medical management) and 453 recruited to the parallel non-randomised preference arm (261 chose surgical management, 192 chose to continue with best medical management). The type of fundoplication was left to the discretion of the surgeon. MAIN OUTCOME MEASURES: Participants completed a baseline REFLUX questionnaire, developed specifically for this study, containing a disease-specific outcome measure, the Short Form with 36 Items (SF-36), the EuroQol-5 Dimensions (EQ-5D) and the Beliefs about Medicines and Surgery questionnaires (BMQ/BSQ). Postal questionnaires were completed at participant-specific time intervals after joining the trial (equivalent to approximately 3 and 12 months after surgery). Intraoperative data were recorded by the surgeons and all other in-hospital data were collected by the research nurse. At the end of the study period, participants completed a discrete choice experiment questionnaire. RESULTS: The randomised groups were well balanced at entry. Participants had been taking GORD medication for a median of 32 months; the mean age of participants was 46 years and 66% were men. Of 178 randomised to surgery, 111 (62%) actually had fundoplication. There was a mixture of clinical and personal reasons why some patients did not have surgery, sometimes related to long waiting times. A total or partial wrap procedure was performed depending on surgeon preference. Complications were uncommon and there were no deaths associated with surgery. By the equivalent of 12 months after surgery, 38% in the randomised surgical group (14% amongst those who had surgery) were taking reflux medication compared with 90% in the randomised medical group. There were substantial differences (one-third to one-half standard deviation) favouring the randomised surgical group across the health status measures, the size depending on assumptions about the proportion that actually had fundoplication. These differences were the same or somewhat smaller than differences observed at 3 months. The lower the REFLUX score, the worse the symptoms at trial entry and the larger the benefit observed after surgery. The preference surgical group had the lowest REFLUX scores at baseline. These scores improved substantially after surgery, and by 12 months they were better than those in the preference medical group. The BMQ/BSQ and discrete choice experiment did distinguish the preference groups from each other and from the randomised groups. The latter indicated that the risk of serious complications was the most important single attribute of a treatment option. A within-trial cost-effectiveness analysis suggested that the surgery policy was more costly (mean 2049 pounds) but also more effective [+0.088 quality-adjusted life-years (QALYs)]. The estimated incremental cost per QALY was 19,000-23,000 pounds, with a probability between 46% (when 62% received surgery) and 19% (when all received surgery) of cost-effectiveness at a threshold of 20,000 pounds per QALY. Modelling plausible longer-term scenarios (such as lifetime benefit after surgery) indicated a greater likelihood (74%) of cost-effectiveness at a threshold of 20,000 pounds, but applying a range of alternative scenarios indicated wide uncertainty. The expected value of perfect information was greatest for longer-term quality of life and proportions of surgical patients requiring medication. CONCLUSIONS: Amongst patients requiring long-term medication to control symptoms of GORD, surgical management significantly increases general and reflux-specific health-related quality of life measures, at least up to 12 months after surgery. Complications of surgery were rare. A surgical policy is, however, more costly than continued medical management. At a threshold of 20,000 pounds per QALY it may well be cost-effective, especially when putative longer-term benefits are taken into account, but this is uncertain. The more troublesome the symptoms, the greater the potential benefit from surgery. Uncertainty about cost-effectiveness would be greatly reduced by more reliable information about relative longer-term costs and benefits of surgical and medical policies. This could be through extended follow-up of the REFLUX trial cohorts or of other cohorts of fundoplication patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15517081.

Evaluating podiatry services: testing a treatment specific measure of health status.

This study reports on the preliminary testing of a new measure designed for use alongside EQ-5D in evaluating outcomes in podiatry: the Podiatry Health Questionnaire (PHQ). Individuals aged 18 years or more, receiving podiatry services in clinic or domicilliary locations across four NHS Trusts in Yorkshire and Humberside UK took part in a questionnaire survey. Respondents reported high levels of problems on all six PHQ dimensions. Correlations suggested that the PHQ and EQ-5D were measuring distinct constructs. The levels on each dimension were well defined in terms of self-rated morbidity on the PHQ visual analogue scale (PHQvas) and the EQ-5Dvas, although PHQvas appeared to be slightly more sensitive to changes in health on the dimensions. There was a strong relationship between clinicians' Podiatry Clinical Score rating and reported symptoms for four out of six PHQ dimensions and PHQvas. The PHQ was able to distinguish respondents in terms of their self-reported morbidity in EQ-5D and in terms of their morbidity as assessed by clinicians. It is suggested that the respondent completed PHQ appears to be a useful new measure for assessing foot-related health. However, further investigation of the psychometric properties of the measure is required.

"Death" and the valuation of health-related quality of life.

BACKGROUND AND OBJECTIVES: Despite evidence to the contrary, a common assumption in the area of health status measurement is that the state "dead" is the worst possible health state and by definition should be assigned a value of 0. However, the value of the state "dead" and the notion of states worse than "dead" have never been fully addressed as a research topic. This article demonstrates the extent of the variation in the value given to the state "dead" by individuals and the effects of transformation on individual and aggregate values using data elicited with 2 methods (visual analog scale rating and ranking) that place no constraint on the value given to the state "dead." RESEARCH DESIGN: Face-to-face interviews were conducted with 253 adults in North Yorkshire, UK, in 1998. Each participant performed ranking and visual analog scale rating exercises for 19 EuroQol EQ-5D health states. CONCLUSIONS AND RESULTS: Data showed that there is a small group of individuals who, when given the option, choose to place relatively high value on the state "dead" compared with other health states. This did not appear to be due to artifact. Evidence also suggested that the usual assumptions underlying the transformation of health state values, for which the distance between full health and "dead" is used to define the denominator, may not hold for these individuals and may distort aggregate preference structures. The authors stress the need for more systematic inquiry in this field.

The role of personal therapy for therapists: a review.

This paper reviews the research literature on personal therapy and makes some recommendations for how future work in this area may be improved. Despite the general acceptance of the importance of personal therapy amongst therapists, there has been relatively little research to evaluate its effectiveness. The vast majority of studies have consisted of surveys of therapists' opinions and experiences of therapy or naturalistic comparisons across therapists who have or have not had therapy. The interpretation of most findings is compromised because of small sample sizes and confounding variables, nevertheless some conclusions can be made. Whilst the majority of therapists feel that they have benefited professionally from personal therapy there is very little empirical evidence that it has any measurable effect on client outcome. However, there is some evidence that personal therapy has a positive effect on those therapist qualities often cited as constructive to client change (e.g. empathy, warmth, genuineness). What is evident is that there is a need for more methodologically sound research as well as a more theoretical understanding of how personal therapy affects clinical practice, before any firm conclusions can be drawn about its usefulness. It is suggested that it may be more useful for future research in this area to focus on therapy process rather than client outcome.

Women's employment transitions around child bearing.

PIP: Women's increasing participation in the labor force since the 1950s demands that knowledge about their labor supply needs to keep pace with the changing world. One important change has occurred among mothers of small children, they are increasingly working for pay in successive generations, as the break in their employment has become increasingly shorter. Legislation was enacted in the UK to outlaw unequal pay and discrimination in employment on the basis of gender, while statutory maternity leave was introduced in 1976 and extended in 1986. The proportion of mothers taking maternity leave has since increased, as has full-time employment among mothers. The authors examine the transitions into and out of paid work which women make after childbirth, helping to determine whether recent generations of mothers have benefitted from the policy changes, whether all have benefitted equally, and whether any effects persist beyond the period around the first childbirth. Study data are drawn from the fifth sweep of the National Child Development Study (NCDS) 1958 birth cohort at age 33. The experiences of mothers in the 1958 generation suggests that women have begun to benefit from the equal opportunities provisions enacted in Britain during the 1970s. The age of the youngest child is the most important determinant of women's participation over the preschool years, and relatively better educated women have the highest degree of continuity in employment across childbirth.^ieng

Women's health: dimensions and differentials.

This paper is concerned with the social patterning of ill-health amongst women in Britain. It uses the various health measures available in the Health and Lifestyle Survey (self-assessed health, disease/disability, illness, psycho-social well-being and fitness) to explore whether there are particular aspects of health systematically associated with social advantage and disadvantage, as measured by current or last occupation, employment status, household composition and household income. Among women aged 18-59, after controlling for age, number of psychological symptoms experienced in the past month showed the greatest social variation. Number of physical illness symptoms in the last month showed the least. Lone mothers with dependent children were found to have particularly poor psycho-social health, although this was confined to those in full-time employment. The presence of a long-standing disease/disability proved useful as a control for the influence of health selection in to and out of both employment and motherhood.

Employment after childbearing and women's subsequent labour force participation: evidence from the British 1958 birth cohort.

"Data on women from the British 1958 Cohort Study is used as evidence on the determinants of their labour force participation at age 33. A conventional cross-sectional model of full or part-time employment makes use of some longitudinal material not normally included in such models. Whether the woman made the hitherto customary break from employment at the time of the first maternity is included in recognition that this cohort was among the first generation to be offered Statutory Maternity Leave. Results suggest that the presence of children (still) inhibits full-time employment and raises the probability of part-time employment; that income effects on participation have continued to weaken while wage elasticity for full-time employment is high. Continuity of employment straight after childbearing raises the chances of subsequent full-time employment, but by no means guarantees it. Gains from maternity leave and other family friendly employment policies have been far from uniform."

Double burden or double blessing? Employment, motherhood and mortality in the Longitudinal Study of England and Wales.

The OPCS Longitudinal Study has been used to follow up women who were married at the time of the 1971 census, to see if their employment status and responsibility for children at that time had any detectable consequence for their mortality up to 1985. Of particular interest was whether the combination of employment and child rearing produced any signs of role overload, or its opposite hypothesized effect, role enhancement. The results show poorer health among those with neither employment nor children, but these effects did not appear to interact. We suspect the data reveal health selection as much as health effects of the roles taken separately. Whatever the stresses and strains of combining jobs and child rearing, they do not appear drastic enough to result in early death.