Long-term cost-effectiveness of screening for fracture risk in a UK primary care setting: the SCOOP study.

Community-based screening and treatment of women aged 70-85 years at high fracture risk reduced fractures; moreover, the screening programme was cost-saving. The results support a case for a screening programme of fracture risk in older women in the UK. INTRODUCTION: The SCOOP (screening for prevention of fractures in older women) randomized controlled trial investigated whether community-based screening could reduce fractures in women aged 70-85 years. The objective of this study was to estimate the long-term cost-effectiveness of screening for fracture risk in a UK primary care setting compared with usual management, based on the SCOOP study. METHODS: A health economic Markov model was used to predict the life-time consequences in terms of costs and quality of life of the screening programme compared with the control arm. The model was populated with costs related to drugs, administration and screening intervention derived from the SCOOP study. Fracture risk reduction in the screening arm compared with the usual management arm was derived from SCOOP. Modelled fracture risk corresponded to the risk observed in SCOOP. RESULTS: Screening of 1000 patients saved 9 hip fractures and 20 non-hip fractures over the remaining lifetime (mean 14 years) compared with usual management. In total, the screening arm saved costs (£286) and gained 0.015 QALYs/patient in comparison with usual management arm. CONCLUSIONS: This analysis suggests that a screening programme of fracture risk in older women in the UK would gain quality of life and life years, and reduce fracture costs to more than offset the cost of running the programme.

Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer.

BACKGROUND: Robust data on patient-reported outcome measures comparing treatments for clinically localized prostate cancer are lacking. We investigated the effects of active monitoring, radical prostatectomy, and radical radiotherapy with hormones on patient-reported outcomes. METHODS: We compared patient-reported outcomes among 1643 men in the Prostate Testing for Cancer and Treatment (ProtecT) trial who completed questionnaires before diagnosis, at 6 and 12 months after randomization, and annually thereafter. Patients completed validated measures that assessed urinary, bowel, and sexual function and specific effects on quality of life, anxiety and depression, and general health. Cancer-related quality of life was assessed at 5 years. Complete 6-year data were analyzed according to the intention-to-treat principle. RESULTS: The rate of questionnaire completion during follow-up was higher than 85% for most measures. Of the three treatments, prostatectomy had the greatest negative effect on sexual function and urinary continence, and although there was some recovery, these outcomes remained worse in the prostatectomy group than in the other groups throughout the trial. The negative effect of radiotherapy on sexual function was greatest at 6 months, but sexual function then recovered somewhat and was stable thereafter; radiotherapy had little effect on urinary continence. Sexual and urinary function declined gradually in the active-monitoring group. Bowel function was worse in the radiotherapy group at 6 months than in the other groups but then recovered somewhat, except for the increasing frequency of bloody stools; bowel function was unchanged in the other groups. Urinary voiding and nocturia were worse in the radiotherapy group at 6 months but then mostly recovered and were similar to the other groups after 12 months. Effects on quality of life mirrored the reported changes in function. No significant differences were observed among the groups in measures of anxiety, depression, or general health-related or cancer-related quality of life. CONCLUSIONS: In this analysis of patient-reported outcomes after treatment for localized prostate cancer, patterns of severity, recovery, and decline in urinary, bowel, and sexual function and associated quality of life differed among the three groups. (Funded by the U.K. National Institute for Health Research Health Technology Assessment Program; ProtecT Current Controlled Trials number, ISRCTN20141297 ; ClinicalTrials.gov number, NCT02044172 .).

A pragmatic randomised controlled trial to evaluate the cost-effectiveness of a physical activity intervention as a treatment for depression: the treating depression with physical activity (TREAD) trial.

OBJECTIVE: The TREAting Depression with physical activity (TREAD) study investigated the cost-effectiveness of a physical activity intervention, in addition to usual general practitioner care, as a treatment for people with depression. DESIGN: An individually randomised, pragmatic, multicentre randomised controlled trial with follow-up at 4, 8 and 12 months. A subset of participants took part in a qualitative study that investigated the acceptability and perceived benefits of the intervention. SETTING: General practices in the Bristol and Exeter areas. PARTICIPANTS: Aged 18-69 years with an International Statistical Classification of Diseases and Related Health Problems, 10th Edition (ICD-10) diagnosis of depression and scoring ≥ 14 on the Beck Depression Inventory (BDI). Those who were unable to complete self-administered questionnaires in English, with medical contraindications to physical activity or with psychosis, bipolar disorder or serious drug abuse were excluded. INTERVENTIONS: We devised an intervention designed to encourage choice and autonomy in the adoption of physical activity. It consisted of up to three face-to-face and ten telephone contacts delivered by a trained physical activity facilitator over an 8-month period. MAIN OUTCOME MEASURES: The primary outcome was the BDI score measured at 4 months. Secondary outcomes included depressive symptoms over the 12 months and quality of life, antidepressant use and level of physical activity. RESULTS: The study recruited 361 patients, with 182 randomised to the intervention arm and 179 to the usual care arm; there was 80% retention at the 4-month follow-up. The intervention group had a slightly lower BDI score at 4 months [-0.54, 95% confidence interval (CI) -3.06 to 1.99] but there was no evidence that the intervention improved outcome for depression. Neither was there any evidence to suggest a difference in the prescription of or self-reported use of antidepressants. However, the amount of physical activity undertaken by those who had received the intervention was increased (odds ratio 2.3, 95% CI 1.3 to 3.9) and was sustained beyond the end of the intervention. From a health-care perspective, the intervention group was more costly than the usual care group, with the cost of the intervention £220 per person on average. It is therefore extremely unlikely that the intervention is cost-effective as a treatment for depression using current willingness-to-pay thresholds. CONCLUSIONS: This physical activity intervention is very unlikely to lead to any clinical benefit in terms of depressive symptoms or to be a cost-effective treatment for depression. Previous research has reported some benefit and there are three possible reasons for this discrepancy: first, even though the intervention increased self-reported physical activity, the increase in activity was not sufficiently large to lead to a measurable influence; second, only more vigorous activity might be of benefit; and third, previous studies had recruited individuals with a pre-existing commitment to physical activity. Future research is needed to identify and explain the mechanisms by which depression might be effectively treated, including, in particular, specific guidance on the optimum type, intensity and duration of physical activity required to produce a therapeutic effect. TRIAL REGISTRATION: Current Controlled Trials ISRCTN16900744. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 10. See the HTA programme website for further project information.

A pragmatic randomised controlled trial of the effectiveness and cost-effectiveness of screening older women for the prevention of fractures: rationale, design and methods for the SCOOP study.

SCOOP is a UK seven-centre, pragmatic, randomised controlled trial with 5-year follow-up, including 11,580 women aged 70 to 85 years, to assess the effectiveness and cost-effectiveness of a community-based screening programme to reduce fractures. It utilises the FRAX algorithm and DXA to assess the 10-year probability of fracture. Introduction Osteoporotic, or low-trauma, fractures present a considerable burden to the National Health Service and have major adverse effects on quality of life, disability and mortality for the individual. Methods Given the availability of efficacious treatments and a risk assessment tool based upon clinical risk factors and bone mineral density, a case exists to undertake a community-based controlled evaluation of screening for subjects at high risk of fracture, under the hypothesis that such a screening programme would reduce fractures in this population. Results This study is a UK seven-centre, unblinded, pragmatic, randomised controlled trial with a 5-year follow-up period. A total of 11,580 women, aged 70 to 85 years and not on prescribed bone protective therapy will be consented to the trial by post via primary care providing 90% power to detect an 18% decrease in fractures. Conclusions Participants will be randomised to either a screening arm or control. Those undergoing screening will have a 10-year fracture probability computed from baseline risk factors together with bone mineral density measured by DXA in selected subjects. Individuals above an age-dependent threshold of fracture probability will be recommended for treatment for the duration of the trial. Subjects in the control arm will receive 'usual care'. Participants will be followed up 6 months after randomisation and annually by postal questionnaires with independent checking of hospital and primary care records. The primary outcome will be the proportion of individuals sustaining fractures in each group. An economic analysis will be carried out to assess cost-effectiveness of screening. A qualitative evaluation will be conducted to examine the acceptability of the process to participants.

A pragmatic randomised controlled trial to compare antidepressants with a community-based psychosocial intervention for the treatment of women with postnatal depression: the RESPOND trial.

OBJECTIVES: To evaluate clinical effectiveness at 4 weeks of antidepressant therapy for mothers with postnatal depression (PND) compared with general supportive care; to compare outcome at 18 weeks of those randomised to antidepressant therapy with those randomised to listening visits as the first intervention (both groups were to be allowed to receive the alternative intervention after 4 weeks if the woman or her doctor so decided); and to assess acceptability of antidepressants and listening visits to users and health professionals. DESIGN: A pragmatic two-arm individually randomised controlled trial. SETTING: Participants were recruited from 77 general practices: 21 in Bristol, 21 in south London and 35 in Manchester. PARTICIPANTS: A total of 254 women who fulfilled International Classification of Diseases version 10 criteria for major depression in the first 6 postnatal months were recruited and randomised. INTERVENTIONS: Women were randomised to receive either an antidepressant, usually a selective serotonin reuptake inhibitor prescribed by their general practitioner (GP), or non-directive counselling (listening visits) from a specially trained research health visitor (HV). The trial was designed to compare antidepressants with general supportive care for the first 4 weeks, after which women allocated to listening visits commenced their sessions. It allowed for women to receive the alternative intervention if they had not responded to their allocated intervention or wished to change to, or add in, the alternative intervention at any time after 4 weeks. MAIN OUTCOME MEASURES: The duration of the trial was 18 weeks. Primary outcome, measured at 4 weeks and 18 weeks post randomisation, was the proportion of women improved on the Edinburgh Postnatal Depression Scale (EPDS), that is scoring < 13. Secondary outcomes were the EPDS measured as a continuous variable at 4 and 18 weeks, and scores on various other questionnaires. RESULTS: At 4 weeks, women were more than twice as likely to have improved if they had been randomised to antidepressants compared with listening visits, which started after the 4-week follow-up, i.e. after 4 weeks of general supportive care [primary intention-to-treat (ITT), 45% versus 20%; odds ratio (OR) 3.4, 95% confidence interval (CI) 1.8 to 6.5, p < 0.001]. Explanatory analyses emphasised these findings. At 18 weeks, ITT analysis revealed that the proportion of women improving was 11% greater in the antidepressant group, but logistic regression analysis showed no clear benefit for one group over the other [62% versus 51%, OR 1.5 (95% CI 0.8 to 2.6), p = 0.19]. Overall, there was a difference between the groups in favour of the antidepressant group of about 25 percentage points at 4 weeks, which reduced at 18 weeks. No statistical support existed for a benefit of antidepressants at 18 weeks, but 95% CIs could not rule out a clinically important benefit. It was difficult for GPs not to prescribe antidepressants to women randomised to listening visits after the initial 4 weeks, so many women received both interventions in both groups by 18 weeks and consequently power was reduced. Qualitative interviews with women revealed a preference for listening visits but an acceptance that antidepressants might be necessary. They wished to be reassured that their GP and HV were offering continuity of care focusing on their particular set of circumstances. Interviews with GPs and HVs revealed lack of collaboration in managing care for women with PND; neither professional group was willing to assume responsibility. CONCLUSIONS: At 4 weeks, antidepressants were significantly superior to general supportive care. Trial design meant that by 18 weeks many of the women initially randomised to listening visits were also receiving antidepressants, and more vice versa. The lack of evidence for differences at 18 weeks is likely to reflect a combination of reduced power and the considerable degree of switching across the two interventions. Qualitative study revealed that women found both antidepressants and listening visits effective depending on their circumstances and preferences. The trial indicates that early treatment with antidepressants leads to clinical benefit for women with PND.

Paracetamol and ibuprofen for the treatment of fever in children: the PITCH randomised controlled trial.

OBJECTIVES: To establish the relative clinical effectiveness and cost-effectiveness of paracetamol plus ibuprofen compared with paracetamol and ibuprofen separately for time without fever, and the relief of fever-associated discomfort in young children who can be managed at home. DESIGN: The trial design was a single-centre (multisite), individually randomised, blinded, three-arm trial comparing paracetamol and ibuprofen together with paracetamol or ibuprofen separately. SETTING: There were three recruitment settings, as follows: 'local' where research nurses were recruited from NHS primary care sites; 'remote' where NHS sites notified the study of potentially eligible children; and 'community' where parents contacted the study in response to local media advertisements. PARTICIPANTS: Children aged between 6 months and 6 years with fever > or = 37.8 degrees C and < or = 41 degrees C due to an illness that could be managed at home. INTERVENTIONS: The intervention was the provision of, and advice to give, the medicines for up to 48 hours: paracetamol every 4-6 hours (maximum of four doses in 24 hours) and ibuprofen every 6-8 hours (maximum of three doses in 24 hours). Every parent received two bottles, with at least one containing an active medicine. Parents, research nurses and investigators were blinded to treatment allocation by the use of identically matched placebo medicines. The dose of medicine was determined by the child's weight: paracetamol 15 mg/kg and ibuprofen 10 mg/kg per dose. RESULTS: For additional time without fever in the first 4 hours, use of both medicines was superior to use of paracetamol alone [adjusted difference 55 minutes, 95% confidence interval (CI) 33 to 77 minutes; p < 0.001] and may have been as good as ibuprofen (adjusted difference 16 minutes, 95% CI -6 to 39 minutes; p = 0.2). Both medicines together cleared the fever 23 minutes (95% CI 2-45 minutes; p = 0.015) faster than paracetamol alone, but no faster than ibuprofen alone (adjusted difference -3 minutes, 95% CI 24-18 minutes; p = 0.8). For additional time without fever in the first 24 hours, both medicines were superior to paracetamol (adjusted difference 4.4 hours, 95% CI 2.4-6.3 hours; p < 0.001) or ibuprofen (adjusted difference 2.5 hours, 95% CI 0.6-4.5 hours; p = 0.008) alone. No reduction in discomfort or other fever-associated symptoms was found, although power was low for these outcomes. An exploratory analysis showed that children with higher discomfort levels had higher mean temperatures. No difference in adverse effects was observed between treatment groups. The recommended maximum number of doses of paracetamol and ibuprofen in 24 hours was exceeded in 8% and 11% of children respectively. Over the 5-day study period, paracetamol and ibuprofen together was the cheapest option for the NHS due to the lower use of health-care services:14 pounds [standard deviation (SD) 23 pounds] versus 20 pounds (SD 38 pounds) for paracetamol and 18 pounds (SD 40 pounds) for ibuprofen. Both medicines were also cheapest for parents because the lower use of health care services resulted in personal saving on travel costs and less time off work: 24 pounds (SD 46 pounds) versus 26 pounds (SD 63 pounds) for paracetamol and 30 pounds (SD 91 pounds) for ibuprofen. This more than compensated for the extra cost of medication. However, statistical evidence for these differences was weak due to lack of power. Overall, a quarter of children were 'back to normal' by 48 hours and one-third by day 5. Five (3%) children were admitted to hospital, two with pneumonia, two with bronchiolitis and one with a severe, but unidentified 'viral illness'. CONCLUSIONS: Young children who are unwell with fever should be treated with ibuprofen first, but the relative risks (inadvertently exceeding the maximum recommended dose) and benefits (extra 2.5 hours without fever) of using paracetamol plus ibuprofen over 24 hours should be considered. However, if two medicines are used, it is recommended that all dose times are carefully recorded to avoid accidentally exceeding the maximum recommended dose. Manufacturers should consider supplying blank charts for this purpose. Use of both medicines should not be discouraged on the basis of cost to either parents or the NHS. Parents and clinicians should be aware that fever is a relatively short-lived symptom, but may have more serious prognostic implications than the other common symptom presentations of childhood.

Screening in women's health, with emphasis on fetal Down's syndrome, breast cancer and osteoporosis.

Screening tests have become increasingly popular in women's health care over the last two decades. The initiative for screening is typically generated by either an agency or the health care professional being consulted for some reason. In many instances, however, the demand for screening tests is patient driven with the health care provider being poorly prepared to determine the usefulness of screening. This review illustrates the complexity of screening using three disorders where early detection and treatment have the potential to improve the quality and longevity of life. Prenatal diagnosis of Down's syndrome does not offer the parents the opportunity for cure but does offer the opportunity for education and rational choice as the impact of the diagnosis on the family is weighed. The evidence for breast cancer screening is more persuasive for older than younger women, but even in older women, there is a balance of risks and benefits. Treatment options for osteoporosis have improved in terms of reductions in fracture risk as well as beneficial effects on bone density, but evidence of the effectiveness of a screening programme for this condition in an unselected population is lacking. Ultimately, it is crucial that women be provided with clear and comprehensive information about the screening programme, in terms of possible gains but also costs of various kinds: physical, economic and psychological.

A Bayesian approach to analysing the cost-effectiveness of two primary care interventions aimed at improving attendance for breast screening.

AIMS: To assess the cost-effectiveness of two primary care interventions, a letter and a flag, aimed at improving attendance for breast screening among (i) all women invited for breast screening and (ii) non-attenders. METHODS: A probabilistic decision analytic model was developed using Markov chain Monte Carlo simulation implemented in WinBUGS. The model was populated using economic and effectiveness data collected alongside two randomised controlled trials. RESULTS: For all women invited, the incremental cost-effectiveness ratio (ICER) for the letter compared with no intervention is 27 pounds per additional attendance, and the ICER for the combined letter and flag intervention compared to the letter alone is 171 pounds. The corresponding ICERs for non-attenders are 41 pounds and 90 pounds. The flag intervention is an inefficient option in both settings. A large proportion of the costs fall on the practices (25-67%), depending on the intervention and target population. The total costs incurred do not, however, seem prohibitive. Expected value of perfect information suggests that there is greater value in carrying out further research on the intervention implemented among all women invited for breast screening rather than on non-attenders. CONCLUSIONS: The flag intervention alone does not appear to be an efficient option. The choice between the letter and both interventions combined is subjective, depending on the willingness to pay for an additional screening attendance.

Perceptions of patient expectation for an antibiotic: a comparison of walk-in centre nurses and GPs.

BACKGROUND: Patient expectation for a prescription is a recognized influence on GPs' prescribing, particularly in relation to the prescribing of antibiotics. Nurses are now able to supply antibiotics under a Patient Group Direction (PGD) in NHS walk-in centres and may experience similar pressures in this new role. OBJECTIVES: Our aim was to compare walk-in centre nurses' and GPs' perceptions of the influence of patient expectation on their supply of an antibiotic to patients with an acute respiratory tract infection presenting with a sore throat or cough. METHODS: Between June and December 2001, all patients presenting with a sore throat or cough at six walk-in centres and six nearby general practices were eligible to participate in the study. After the health professional-patient consultation, the health professional and the patient each completed a questionnaire. RESULTS: There were 472 health professional (181 GPs and 291 walk-in centres) and 160 (34%, 160 out of 472) patient questionnaires returned. GPs were more likely to report that the patient expected an antibiotic than nurses (72% of 181 versus 13% of 291, P < 0.001). GPs were also less likely to report that an antibiotic was indicated than nurses (88% of 136 versus 97% of 194, P < 0.001). There was a trend for doctors to prescribe more frequently than nurses, in 74% of 180 patients versus 66% of 291 patients (P = 0.06). GPs were likely to report that the patient expected an antibiotic when the patient reported wanting a prescription (60% of 68, P = 0.05) and to report that the patient expected an antibiotic if the patient thought an antibiotic would be beneficial (62% of 68, P = 0.001). There was a much weaker relationship between nurse perceptions of patient expectation for an antibiotic and, either patient desire for a prescription or the patient's affirmative belief that an antibiotic would be beneficial. CONCLUSIONS: Nurses may be compensating for a lack of security in their new role as antibiotic suppliers by not acknowledging the influence of patient expectation on their decision making. The acknowledgement of the influence of patient expectation might be beneficial to nurses' development as suppliers of medicines by giving them greater understanding of the consultation process and in the need to discuss patient expectations explicitly in the consultation.

Comparison of methods for analysing cluster randomized trials: an example involving a factorial design.

BACKGROUND: Studies involving clustering effects are common, but there is little consistency in their analysis. Various analytical methods were compared for a factorial cluster randomized trial (CRT) of two primary care-based interventions designed to increase breast screening attendance. METHODS: Three cluster-level and five individual-level options were compared in respect of log odds ratios of attendance and their standard errors (SE), for the two intervention effects and their interaction. Cluster-level analyses comprised: (C1) unweighted regression of practice log odds; (C2) regression of log odds weighted by their inverse variance; (C3) random-effects meta-regression of log odds with practice as a random effect. Individual-level analyses comprised: (I1) standard logistic regression ignoring clustering; (I2) robust SE; (I3) generalized estimating equations; (I4) random-effects logistic regression; (I5) Bayesian random-effects logistic regression. Adjustments for stratification and baseline variables were investigated. RESULTS: As expected, method I1 was highly anti-conservative. The other, valid, methods exhibited considerable differences in parameter estimates and standard errors, even between the various random-effects methods based on the same statistical model. Method I4 was particularly sensitive to between-cluster variation and was computationally stable only after controlling for baseline uptake. CONCLUSIONS: Commonly used methods for the analysis of CRT can give divergent results. Simulation studies are needed to compare results from different methods in situations typical of cluster trials but when the true model parameters are known.

Clusters within a general adult population of alcohol abstainers.

BACKGROUND: Our previous study found that alcohol abstainers use acute services more and preventative services less than safe level drinkers. The observed relationships between four categories of alcohol consumption and service use were J-shaped for acute services and inverted J-shaped for preventive services. The aim of this paper was to further investigate these relationships. METHODS: The design was a health and lifestyle survey of 41 000 randomly-sampled adults in SE England. The response rate was 60%. Distinctive subgroups within the alcohol abstainer group were investigated using cluster analysis, based on socio-demographic and health status variables. Odds ratios for services use for the abstainer clusters, and three alcohol consumption groups were estimated from a logistic regression model which included age, social class, ethnic group, employment status, household composition, whether the respondent was a carer, smoking habit, use of private health insurance, and health status. RESULTS: Two clusters were formed for both males and females. Cluster 1 comprised, on average, older, frailer, and more disabled people. Cluster 2 comprised younger, healthier people, a greater proportion of whom belonged to ethnic minority groups. Cluster 2 had similar rates of use of Accident & Emergency, GP, optician, and dental services compared with safe level drinkers. Cluster 1's rates differed from those of both Cluster 2 and safe level drinkers in almost all instances. CONCLUSIONS: The J- and inverted J-shaped relationships between alcohol consumption and service use are partly explained by a subgroup of abstainers who are older, of less good health, and who use hospital, clinic, and domiciliary healthcare services much more than safe level drinkers.

Cluster randomised controlled trial comparing the effectiveness and cost-effectiveness of two primary care interventions aimed at improving attendance for breast screening.

OBJECTIVES: To examine the effectiveness and cost-effectiveness of two interventions based in primary care aimed at increasing uptake of breast screening. SETTING: 24 General practices with low uptake in the second round of screening (below 60%) in north west London and the West Midlands, UK. Participants were all women registered with these practices and eligible for screening in the third round. METHODS: Pragmatic factorial cluster randomised controlled trial, with practices randomised to a systematic intervention (general practitioner letter), an opportunistic intervention (flag in women's notes prompting discussion by health professionals), neither intervention, or both. Outcome measures were attendance for screening 6 months after the practices had been screened and cost-effectiveness of the interventions. RESULTS: 6,133 Women were included: 1,721 control; 1,818 letter; 1,232 flag; 1,362 both interventions. Attendance data were obtained for 5,732 (93%) women. The two interventions independently increased breast screening uptake in a logistic regression model adjusted for clustering, with the flag (odds ratio (OR) 1.43, 95% confidence interval (95% CI) 1.14 to 1.79; p=0.0019) marginally more effective than the letter (OR 1.31, 95% CI 1.05 to 1.64; p=0.015). Health service costs per additional attendance were 26 pounds (letter) and 41 pounds (flag). CONCLUSIONS: Although both interventions increased attendance for breast screening, the letter was the more cost-effective. Any decision to implement both interventions rather than just the letter will depend on whether the additional (41 pounds) costs are judged worthwhile in terms of the gains in breast screening uptake.

Improving attendance for breast screening among recent non-attenders: a randomised controlled trial of two interventions in primary care.

OBJECTIVES: To examine the effectiveness and cost-effectiveness of two primary care based interventions aimed at increasing breast screening uptake for women who had recently failed to attend. SETTING: 13 General practices with low uptake in the second round of breast screening (below 60%) in north west London and the West Midlands, United Kingdom. Participants were women in these practices who were recent non-attenders for breast screening in the third round. METHODS: Pragmatic factorial randomised controlled trial, with people randomised to a systematic intervention (general practitioner letter), an opportunistic intervention (flag in women's notes prompting discussion by health professionals), neither intervention, or both. Outcome measures were attendance for screening 6 months after randomisation and cost-effectiveness of the interventions. RESULTS: 1,158 Women were individually randomised as follows: 289 control; 291 letter; 290 flag; 288 both interventions. Attendance was ascertained for 1,148 (99%) of the 1,158 women. Logistic regression adjusting for the other intervention and practice produced an odds ratio (OR) for attendance of 1.51 (95% confidence interval (95% CI 1.02 to 2.26; p=0.04) for the letter, and 1.39 (95% CI 0.93 to 2.07; p=0.10) for the flag. Health service costs/ additional attendance were 35 pounds (letter) and 65 pounds (flag). CONCLUSIONS: Among recent non-attenders, the letter was effective in increasing breast screening attendance. The flag was of equivocal effectiveness and was considerably less cost-effective than the letter.

Effects of patients' preferences on the treatment of atrial fibrillation: observational study of patient-based decision analysis.

OBJECTIVE: To investigate the effect of patients' preferences in the treatment of atrial fibrillation by using individualized decision analysis in which probability and utility assessments are combined into a decision tree. DESIGN: Observational study based on interviews with patients. SETTING: 8 general practices in Avon, England. PARTICIPANTS: 260 randomly selected patients aged 70 to 85 years with atrial fibrillation. MAIN OUTCOME MEASURES: Patients' treatment preferences regarding anticoagulation treatment (warfarin sodium) after individualized decision analysis; comparison of these preferences with treatment guidelines on the basis of comorbidity and absolute risk and compared with current prescription. RESULTS: Of 195 eligible patients, 97 participated in decision making using decision analysis. Among these 97, the decision analysis indicated that 59 (61%; 95% confidence interval, 50%-71%) would prefer anticoagulation treatment, considerably fewer than those who would be recommended treatment according to guidelines. There was marked disagreement between the decision analysis and guideline recommendations (kappa> or =0.25). Of 38 patients whose decision analysis indicated a preference for anticoagulation, 17 (45%) were being prescribed warfarin; on the other hand, 28 (47%) of 59 patients were not being prescribed warfarin, although the results of their decision analysis suggested they wanted to be. CONCLUSIONS: In the context of shared decision making, individualized decision analysis is valuable in a sizable proportion of elderly patients with atrial fibrillation. Taking account of patients' preferences would lead to fewer prescriptions for warfarin than under published recommendations. Decision analysis as a shared decision-making tool should be evaluated in a randomized controlled trial.

Vision-related quality of life impairment in an elderly UK population: associations with age, sex, social class and material deprivation.

PURPOSE: To describe the prevalence of vision-related quality of life (VR-QOL) impairment in an elderly UK population sample. METHOD: The survey, using the VCM1 questionnaire, was based on an age- and sex-stratified random population sample of 2783 individuals aged 55 years or over. RESULTS: One thousand eight hundred and forty-six (69.7%) of 2647 eligible subjects responded. One thousand six hundred and eighty-three individuals completed all 10 VCM1 items. Overall the prevalence of a VCM1 score >2.0 ('more than a little' concern about vision) was 4.6% (95% CI = 3.7% to 5.7%), leading to an estimate of more than 550,000 individuals in England with substantial VR-QOL impairment. The prevalence increased with age from 2.1% in the 55-64 year age group to 17.9% in the group aged 85 years and older. The prevalence also increased as social class became lower, from 0 in social class I to 10.2% in social class V, and increased with increasing material deprivation, from 1.2% in the most affluent quintile to 6.8% in the most deprived quintile. Multivariable logistic regression analysis showed that age (p = 0.0001), decreasing social class (p = 0.03) and increasing material deprivation (p = 0.008) were independently associated with VR-QOL impairment (VCM1 score >2.0), whilst gender and means of questionnaire administration were not associated with VR-QOL impairment at the 5% level. CONCLUSIONS: The findings suggest a substantial national prevalence of VR-QOL impairment, and are consistent with earlier studies linking ocular disease with social deprivation. Consideration should be given to directing resources more carefully towards groups at higher risk of VR-QOL impairment, in particular the very elderly and socially deprived.

The population requirement for cataract extraction: a cross-sectional study.

PURPOSE: To examine the distribution in the population of indications for cataract extraction in order to relate demand for this procedure to the capacity for satisfying it. METHODS: An age-stratified random population sample of 2783 individuals aged 55 years and over was taken from inner-city, urban and rural areas of Avon and Somerset. The requirement for cataract extraction was estimated on the basis of measures of vision-related quality of life, refracted visual acuity, and application of the Oxford Clinical Cataract Classification and Grading System. Data were also collected concerning suitability for surgery, including relative contraindications to surgery and whether participants considered their eyesight bad enough to merit surgery. Three sets of composite indications were defined. RESULTS: Estimated prevalent requirements for cataract extraction for the three sets of composite criteria were: 29 per 1000 aged over 55 years (95% CI 20-41) for the most inclusive criterion; 17 per thousand (95% CI 10-27) for the intermediate criterion; and 7 per thousand (95% CI 3-14) for the most stringent criterion. These rates are equivalent to a national prevalent requirement for England of 384,000 for the most inclusive criterion. If the approximately 15% of individuals whose desire or fitness for surgery was questionable are removed from this estimate, the prevalent requirement, including the backlog from previous unsatisfied demand, becomes 325,000 individuals. CONCLUSIONS: The findings suggest only a modest imbalance between supply and demand for cataract surgery. In particular there was a very small prevalence of untreated severe cataract, less than the annual health service surgical capacity, suggesting that the current National Health Service surgical capacity is adequate for cases of severe cataract.

The impact of patients' preferences on the treatment of atrial fibrillation: observational study of patient based decision analysis.

OBJECTIVE: To investigate the impact of patients' preferences for the treatment of atrial fibrillation, by using individualised decision analysis combining probability and utility assessments into a decision tree. DESIGN: Observational study based on interviews with patients. SETTING: Eight general practices in Avon. PARTICIPANTS: 260 randomly selected patients aged 70-85 years with atrial fibrillation. MAIN OUTCOME MEASURES: Patients' treatment preferences regarding anticoagulation treatment (warfarin) after individualised decision analysis; comparison of these preferences with treatment guidelines on the basis of comorbidity and absolute risk and compared with current prescription. RESULTS: Of 195 eligible patients, 97 participated in decision making using decision analysis. Among these 97, the decision analysis indicated that 59 (61%; 95% confidence interval 50% to 71%) would prefer anticoagulation treatment-considerably fewer than those who would be recommended treatment according to guidelines. There was marked disagreement between the decision analysis and guideline recommendations (kappa=0.25 or less). Of 38 patients whose decision analysis indicated a preference for anticoagulation, 17 (45%) were being prescribed warfarin; on the other hand, 28 (47%) of 59 patients were not being prescribed warfarin although the results of their decision analysis suggested they wanted to be. CONCLUSIONS: In the context of shared decision making, individualised decision analysis is valuable in a sizeable proportion of elderly patients with atrial fibrillation. Taking account of patients' preferences would lead to fewer prescriptions for warfarin than under published guideline recommendations. Decision analysis as a shared decision making tool should be evaluated in a randomised controlled trial.

Anxiety amongst women with mild dyskaryosis: costs of an educational intervention.

BACKGROUND: A randomized controlled trial in primary care investigated whether a structured educational intervention had an impact on the psychological morbidity associated with a 6-month period of surveillance for mild dyskaryosis. In the context of high levels of sustained distress, and few differences in terms of objective measures of anxiety, the intervention led to a greater proportion of women who were comfortable with a 6-month interval before their next smear test. OBJECTIVE. The aim of this paper is to evaluate the implications to general practices and the NHS, in terms of both costs and numbers of patient contacts, of a change from current policy to one of actively inviting all women with mild dyskaryosis to consult the practice nurse for the intervention. METHODS: We conducted a pragmatic, cluster-randomized controlled trial, comparing the intervention with standard care. The setting was general practices in Avon and South Glamorgan, UK. The subjects were women under surveillance following their first ever mildly dyskaryotic cervical smear result. The main outcome measures were as follows. Costs were reported according to randomization group, from the viewpoint of general practices and the NHS. The main elements which were costed were those attributable to production of the package and training in its use, and the costs of consultations subsequent to the woman receiving her smear test result. In addition, since in practice the intervention might be applied in different circumstances to those prevailing in the trial, a sensitivity analysis was performed to assess the costs of the educational package as realistically as possible. RESULTS: Almost twice as many women in the intervention group compared with the control group visited their practice to discuss their result. From the perspective of the practices, a change from current policy to the intervention policy led to potential (negligible) savings of around pound sterling 3.50 per partner per year. From the NHS perspective, the intervention would lead to slightly increased costs of between pound sterling 1000 and pound sterling 2500 per year for an area performing 60000 tests per year. CONCLUSIONS: It is both feasible and acceptable for practice nurses to deliver the educational package. Moreover, from the perspective of a practice, the policy is effectively cost-neutral. The main implication for general practices is the change in the pattern of care provided: fewer women consulted their GP about their smear result and many more, following active encouragement, consulted the practice nurse.

Population requirement for primary hip-replacement surgery: a cross-sectional study.

BACKGROUND: There has been a long-standing failure in many countries to satisfy the demand for several elective surgical treatments, including total hip replacement. We set out to estimate the population requirement for primary total hip replacement in England. METHODS: We undertook a cross-sectional study of a stratified random sample of 28,080 individuals aged 35 and over from 40 general practices in inner-city, urban, and rural areas of Avon and Somerset, UK. Prevalent disease was identified through a two-stage process: a self-report screening questionnaire (22,978 of 26,046 responded) and subsequent clinical examination. Incident disease was estimated from the point prevalence by statistical modelling. The requirement for total hip replacement surgery was estimated on the basis of pain and loss of functional ability, with adjustment for evidence of comorbidity and patients' treatment preferences. FINDINGS: 3169 people reported hip pain on the screening questionnaire. 2018 were invited for clinical examination, and 1405 attended. The prevalence of self-reported hip pain was 107 per 1000 (95% CI 101-113) for men and 173 per 1000 (166-180) for women. The prevalence of hip disease severe enough to require surgery was 15.2 (12.7-17.8) per 1000 aged 35-85 years. The corresponding annual incidence of hip disease requiring surgery was estimated as 2.23 (1.56-2.90), which suggests an overall requirement in England of 46,600 operations per year for patients who expressed a preference for, and were suitable for, surgery; the recent actual provision in England was about 43,500. INTERPRETATION: This research suggests that the satisfaction of demand for total hip replacement, given agreed criteria for surgery, is a realistic objective.