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Background Pharmaceutical care serves as a collaborative model for medication review. Its use is advocated for older patients, although its cost-effectiveness is unknown. Although the accompanying article on clinical effectiveness from the RESPECT (Randomised Evaluation of Shared Prescribing for Elderly people in the Community over Time) trial finds no statistically significant impact on prescribing for older patients undergoing pharmaceutical care, economic evaluations are based on an estimation, rather than hypothesis testing. Aim To evaluate the cost-effectiveness of pharmaceutical care for older people compared with usual care, according to National Institute for Health and Clinical Excellence (NICE) reference case standards. Method An economic evaluation was undertaken in which NICE reference case standards were applied to data collected in the RESPECT trial. Results On average, pharmaceutical care is estimated to cost an incremental £10 000 per additional quality-adjusted life year (QALY). If the NHS's cost-effectiveness threshold is between £20 000 and £30 000 per extra QALY, then the results indicate that pharmaceutical care is cost-effective despite a lack of statistical significance to this effect. However, the statistical uncertainty surrounding the estimates implies that the probability that pharmaceutical care is not cost-effective lies between 0.22 and 0.19. Although results are not sensitive to assumptions about costs, they differ between subgroups: in patients aged >75 years pharmaceutical care appears more cost-effective for those who are younger or on fewer repeat medications. Conclusion Although pharmaceutical care is estimated to be cost-effective in the UK, the results are uncertain and further research into its long-term benefits may be worthwhile. [ABSTRACT FROM AUTHOR]

Objective: To establish whether women with low-grade abnormalities detected during screening for cervical cancer prefer to be managed by cytological surveillance or by immediate colposcopy. Methods: TOMBOLA (Trial of Management of Borderline and Other Low-grade Abnormal smears) is a randomized controlled trial comparing alternative management strategies following the screen-detection of low-grade cytological abnormalities. At exit, a sample of TOMBOLA women completed a questionnaire eliciting opinions on their management, contingent valuations (CV) of the management methods and preferences. Within-trial quality of life (EQ-5D) data collected for a sample of TOMBOLA women throughout their follow-up enabled the comparison of self-reported health at various time points, by management method. Results: Once management had been initiated, self-reported health in the colposcopy arm rose relative to that in the surveillance arm, although the effect was short-term only. For the majority of women, the satisfaction ratings and the CV indicated approval of the management method to which they had been randomized. Of the minority manifesting a preference for the method which they had not experienced, relatively more would have preferred colposcopy than would have preferred surveillance. Conclusions: The findings must be interpreted in the light of sample bias with respect to preferences, whereby enthusiasm for colposcopy was probably over-represented amongst trial participants. The study suggests that neither of the management methods is preferred unequivocally; rather, individual women have individual preferences, although many would be indifferent between methods. [ABSTRACT FROM AUTHOR]

PURPOSE: To evaluate alternative approaches taken to estimate the population that could benefit from research and to demonstrate that explicitly modeling future change leads to more appropriate estimates of the expected value of information (EVI). METHODS: Existing approaches to estimating the population typically focus on the time horizon for decisions, employing seemingly arbitrary estimates of the appropriate horizon. These approaches implicitly use the time horizon as a proxy for future changes in technologies, prices, and information. Different approaches to quantifying the time horizon are explored, in the context of a stylized model, to demonstrate the impact of uncertainty in this estimate on EVI. An alternative approach is developed that explicitly models future changes in technologies, prices, and information and that demonstrates the impact on EVI estimates. RESULTS: Explicitly modeling future changes means that the EVI for the decision problem may increase or decrease over time, but the EVI for the group of parameters that can be evaluated by current research tends to decline. The finite and infinite time horizons for the decision problem represent special cases (e.g., price shock or no changes, respectively). This type of analysis can be used to inform policy decisions relating to the timing of research. CONCLUSIONS: The value of information depends on future changes in technologies, prices, and evidence. Finite time horizons for decision problems can be seen as a proxy for the complex and uncertain process of future change. A more explicit approach to modeling these changes could provide a more appropriate basis for calculating EVI, but this raises a number of significant methodological and technical challenges. [ABSTRACT FROM AUTHOR]

Receipt of an abnormal cervical smear result often generates fear and confusion and can have a negative impact on a woman's well-being. Most previous studies have focussed on high-grade abnormal smears. This study describes the psychological and psychosocial effects, on women, of having received a low-grade abnormal smear result. Over 3500 women recruited to TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) participated in this study. Anxiety was assessed using the Hospital Anxiety and Depression Scale (HADS) at recruitment. Socio-demographic and lifestyle factors, locus of control and factors associated with the psychosocial impact of the abnormal smear result were also assessed. Women reported anxiety levels consistent with those found in previous studies of women with high-grade smear results. Women at highest risk of anxiety were younger, had children, were current smokers, or had the highest levels of physical activity. Interventions that focus particularly on women's understanding of smear results and pre-cancer, and/or directly address their fears about cancer, treatment and fertility might provide the greatest opportunity to reduce the adverse psychosocial impact of receiving a low-grade abnormal cervical smear result. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To predict the likely impact of adding human papillomavirus (HPV) triage for minor abnormalities on participation in the English cervical cancer screening program. METHOD: Contingent valuations of the existing Pap program and a possible HPV-augmented screening program, obtained from questionnaires completed by 1141 women in east-central England. RESULTS: The value of participating in Pap screening was negatively associated with age, positively associated with educational level, and positively associated with the level of household income. Higher levels of worry about cervical cancer were associated with higher valuations of screening. Adding HPV-based triage to the Pap program lowered the value of screening participation for only two women, whereas for the sample as a whole, it increased the average valuation by about 47 percent. Supposedly-negative characteristics of HPV testing, when described, were expected to trigger psychosocial concerns in respondents and thereby give rise to significant decreases in valuations of participating in a Pap-plus-HPV program. For most women, however, such information changed their valuations of participation in screening little, if at all. CONCLUSIONS: Accepting the proposition that higher contingent valuations indicate stronger behavioural preferences, our results offer insubstantial grounds for believing that the inclusion of HPV triage would detrimentally affect participation in Pap screening for cervical cancer. [ABSTRACT FROM AUTHOR]

This paper describes the process of developing and testing a new questionnaire, Process Outcome Specific Measure (POSM), including an assessment of its content validity and reliability. The questionnaire was developed within the context of Trial Of Management of Borderline and Other Low-grade Abnormal smears (TOMBOLA) to assess the psychosocial impact of a low-grade abnormal cervical smear result and the subsequent management. A literature search, focus groups and thorough pre-testing involving experts and patients resulted in a short (15-item), easily completed and understood questionnaire. Questions address issues including cancer, health, fertility and sexual concerns. Repeatability was assessed in 110 TOMBOLA recruits using weighted k; all but one of the questions showed levels of reliability near to, or above, 0.5. Cronbach's standardised alpha was 0.73, indicating acceptable internal consistency. Each POSM item was correlated with the anxiety and depression sub-scales of the Hospital Anxiety Depression Scale (HADS). All except one of the questions correlated more highly with the total POSM score than with the HADS sub-scales thus indicating discriminant validity. The POSM will enable comparison of the alternative management policies for low-grade cervical smears in terms of the benefits (or otherwise) perceived by the women managed by these policies. [ABSTRACT FROM AUTHOR]

The aim of this study is to evaluate different options for introducing liquid-based cytology (LBC) and human papillomavirus (HPV) testing into the UK cervical cancer screening programme. These include options that incorporate HPV testing either as a triage for mild and borderline smear abnormalities or as a primary screening test. Outcomes include the predicted impact on resource use, total cost, life years and cost-effectiveness. Extensive sensitivity analysis has been carried out to explore the importance of the uncertainty associated with disease natural history and the impact of screening. Under baseline assumptions, the cost-effectiveness of different options for introducing LBC appears favourable, and these results are consistent under a range of assumptions for its impact on the diagnostic effectiveness of cytology. However, if we assume a higher marginal cost of LBC in comparison to conventional methods, primary smear testing options are predicted to be more cost-effective without LBC. Combined LBC primary smear and HPV testing with a 5-year interval is similar in both cost and effectiveness to the other 3-yearly options of primary smear testing or primary HPV testing alone. However, both primary HPV testing and combined options would give rise to a far greater risk of inappropriate colposcopy throughout a woman's lifetime. British Journal of Cancer (2004) 91, 84-91. doi:10.1038/sj.bjc.6601884 www.bjcancer.com Published online 25 May 2004 [ABSTRACT FROM AUTHOR]

The aim of this study is to evaluate different options for introducing liquid-based cytology (LBC) and human papillomavirus (HPV) testing into the UK cervical cancer screening programme. These include options that incorporate HPV testing either as a triage for mild and borderline smear abnormalities or as a primary screening test. Outcomes include the predicted impact on resource use, total cost, life years and cost-effectiveness. Extensive sensitivity analysis has been carried out to explore the importance of the uncertainty associated with disease natural history and the impact of screening. Under baseline assumptions, the cost-effectiveness of different options for introducing LBC appears favourable, and these results are consistent under a range of assumptions for its impact on the diagnostic effectiveness of cytology. However, if we assume a higher marginal cost of LBC in comparison to conventional methods, primary smear testing options are predicted to be more cost-effective without LBC. Combined LBC primary smear and HPV testing with a 5-year interval is similar in both cost and effectiveness to the other 3-yearly options of primary smear testing or primary HPV testing alone. However, both primary HPV testing and combined options would give rise to a far greater risk of inappropriate colposcopy throughout a woman's lifetime.British Journal of Cancer (2004) 91, 84-91. doi:10.1038/sj.bjc.6601884 www.bjcancer.com Published online 25 May 2004 [ABSTRACT FROM AUTHOR]

Z. Philips, M. Avis and D. K. Whynes Women's interpretation of cervical smear test results Screening for cervical cancer using the Papanicolaou smear test has been available in England since the 1960s, yet very little is known about how women interpret their test results. This questionnaire study required women to explain, in their own words, the meaning of normal and abnormal test results. It was discovered that the use of the word cell as a description of findings was extremely common, and that a proportion of subjects equated abnormal results with technical inadequacy. The frequency of circularity in the interpretations, i.e. interpreting ‘normal’ as ‘not abnormal’ and vice versa, was striking. Contrary to previous research, we find that, whilst many women interpret normal results as indicating the current absence of cancer, few appear to believe that future cancer is thereby definitively ruled out. By the same token, only a very small minority interpret abnormal results as definitive of cancer. [ABSTRACT FROM AUTHOR]

Background: This trial aims to investigate the effectiveness and cost implications of 'pharmaceutical care' provided by community pharmacists to elderly patients in the community. As the UK government has proposed that by 2004 pharmaceutical care services should extend nationwide, this provides an opportunity to evaluate the effect of pharmaceutical care for the elderly. Design: The trial design is a randomised multiple interrupted time series. We aim to recruit 700 patients from about 20 general practices, each associated with about three community pharmacies, from each of the five Primary Care Trusts in North and East Yorkshire. We shall randomise the five resulting groups of practices, pharmacies and patients to begin pharmaceutical care in five successive phases. All five will act as controls until they receive the intervention in a random sequence. Until they receive training community pharmacists will provide their usual dispensing services and so act as controls. The community pharmacists and general practitioners will receive training in pharmaceutical care for the elderly. Once trained, community pharmacists will meet recruited patients, either in their pharmacies (in a consultation room or dispensary to preserve confidentiality) or at home. They will identify drug-related issues/problems, and design a pharmaceutical care plan in conjunction with both the GP and the patient. They will implement, monitor, and update this plan monthly. The primary outcome measure is the 'Medication Appropriateness Index'. Secondary measures include adverse events, quality of life, and patient knowledge and compliance. We shall also investigate the cost of pharmaceutical care to the NHS, to patients and to society as a whole. [ABSTRACT FROM AUTHOR]

The study reports a questionnaire survey of female university students intended (1) to delineate their knowledge of cervical cancer and screening, and (2) to impute their valuation of the introduction of human papillomavirus (HPV) testing. It was found that almost 80% of respondents thought cervical cancer was a leading cause of cancer death amongst women. Most subjects consistently over-estimated the incidence of cervical cancer, consistent with the social amplification hypothesis. The major risk factors were accurately identified by the majority, although family history was emphasized to a degree unwarranted by epidemiological evidence. Subjects' knowledge of the screening programme was accurate in some respects, but not in others, e.g. the majority under-estimated the abnormality rate and over-estimated the age at which abnormalities typically occurred. Subjects placed a premium on the increased accuracy which HPV testing might potentially offer, predictable from their beliefs about the performance of the existing screening programme. Policy makers can be reassured that female university students appear unconcerned about undergoing a test for a sexually transmitted disease, although their beliefs about cervical cancer and the power of screening are distorted, and their enthusiasm for HPV testing relates to an, as yet, unconfirmed belief in its accuracy. [ABSTRACT FROM AUTHOR]

The way in which women are informed about borderline or mild smear results can have a significant psychological impact. By means of a questionnaire survey of general practices in Nottingham, England, this study audited the means by which abnormal smear results were normally communicated to subjects and analysed the content of these communications. Transmitting abnormal smear results, either by letter or by telephone call, was typically the responsibility of the practice nurse, and communications varied widely in informational content. We conclude that the method and content of communications imparting mild or borderline smear results differs between general practices, even within a small geographical area. [ABSTRACT FROM AUTHOR]

IVF treatment, which involves ovarian stimulation, poses significant health problems such as ovarian hyperstimulation and is associated with a high incidence of multiple pregnancy and premature birth. In this paper, we demonstrate how natural cycle IVF is an effective and potentially cost-effective alternative treatment option for certain groups of infertile couples. The study was conducted in the Assisted Conception Unit at King's College School of Medicine, London. Fifty-two women with regular menstrual cycles whose partners had normal semen parameters were offered a total of 181 cycles of treatment (average 3.49 per couple). Life table analysis was used to calculate cumulative success rates after successive cycles of treatment. After four cycles, the cumulative probability of pregnancy was 46% with an associated live birth rate of 32%. To achieve maximal effectiveness, natural cycle IVF should be offered as a series of treatment cycles, for it is safer, less stressful and can be offered over consecutive cycles. Moreover, the avoidance of expensive drugs and reduced intensity of monitoring make natural cycle IVF less expensive than conventional treatment involving stimulation. We calculate that this treatment can be offered at approximately 23% of the cost of a stimulated cycle, suggesting that it may be a cost-effective alternative to conventional assisted conception techniques. [ABSTRACT FROM AUTHOR]

This paper aims to complement existing clinical guidelines by providing evidence of the relative cost-effectiveness of treatments for infertility in the UK. A series of decision-analytical models have been developed to reflect current diagnostic and treatment pathways for the five main causes of infertility. Data to populate the models are derived from a systematic review and routine National Health Service activity data, and are augmented with expert opinion. Costs are derived from an analysis of extra-contractual referral tariffs and private sector data. Sensitivity analysis has been carried out to take account of the uncertainty of model parameters and to allow results to be interpreted in the light of local circumstances. Results of the modelling exercise suggest in-vitro fertilization is the most cost-effective treatment option for severe tubal factors and endometriosis, with surgery the most cost-effective in the case of mild or moderate disease. Ovulatory factors should be treated medically with the addition of laparoscopic ovarian diathermy in the presence of polycystic ovarian syndrome. For other causes, stimulated intrauterine insemination (unexplained and moderate male factor) and stimulated donor intrauterine insemination (severe male) are cost-effective. [ABSTRACT FROM AUTHOR]

This paper aims to complement existing clinical guidelines by providing evidence of the relative cost-effectiveness of treatments for infertility in the UK. A series of decision–analytical models have been developed to reflect current diagnostic and treatment pathways for the five main causes of infertility. Data to populate the models are derived from a systematic review and routine National Health Service activity data, and are augmented with expert opinion. Costs are derived from an analysis of extra-contractual referral tariffs and private sector data. Sensitivity analysis has been carried out to take account of the uncertainty of model parameters and to allow results to be interpreted in the light of local circumstances. Results of the modelling exercise suggest in-vitro fertilization is the most cost-effective treatment option for severe tubal factors and endometriosis, with surgery the most cost-effective in the case of mild or moderate disease. Ovulatory factors should be treated medically with the addition of laparoscopic ovarian diathermy in the presence of polycystic ovarian syndrome. For other causes, stimulated intrauterine insemination (unexplained and moderate male factor) and stimulated donor intrauterine insemination (severe male) are cost-effective. [ABSTRACT FROM PUBLISHER]