Cost-comparison study of reusable and disposable rhinolaryngoscopes in a large English teaching hospital.

OBJECTIVE: This study aimed to compare the cost per use of video-rhinolaryngoscopy using reusable and disposable devices in a tertiary referral centre. METHODS: A cost-comparison study was performed that utilised retrospective cost data and prospective utilisation data to compare the total costs of using reusable video-rhinolaryngoscopes versus a single-use alternative. RESULTS: It was estimated that 4776 and 1821 procedures were performed annually with reusable and disposable video-rhinolaryngoscopes, respectively. The cost per use was £66.61 for reusable devices versus £150.00 for disposable devices. The break-even point (i.e. when cost per use was equal, occurred at 1374 procedures per year). Thereafter, it was cheaper to use reusable devices. CONCLUSION: Disposable rhinolaryngoscopes may present a cheaper solution to services with low rates of rhinolaryngoscope utilisation. However, for larger services considering replacement of their reusable rhinolaryngoscopes with disposable units, it is likely that the recurring costs will be prohibitive in the medium to long term.

Psychosocial morbidity in women with abnormal cervical cytology managed by cytological surveillance or initial colposcopy: longitudinal analysis from the TOMBOLA randomised trial.

OBJECTIVE: To compare psychosocial outcomes (follow-up related worries and satisfaction with follow-up related information and support) over 30 months of two alternative management policies for women with low-grade abnormal cervical cytology. METHODS: Women aged 20-59 years with low-grade cytological abnormalities detected in the National Health Service Cervical Screening Programme were randomised to cytological surveillance or initial colposcopy. A total of 3399 women who completed psychosocial questionnaires at recruitment were invited to complete questionnaires at 12, 18, 24 and 30 months. Linear mixed models were used to investigate differences between arms in the two psychosocial outcomes. Each outcome had a maximum score of 100, and higher scores represented higher psychosocial morbidity. RESULTS: On average, over 30 months, women randomised to colposcopy scored 2.5 points (95%CI -3.6 to -1.3) lower for follow-up related worries than women randomised to cytological surveillance. Women in the colposcopy arm also scored significantly lower for follow-up related satisfaction with information and support (-2.4; -3.3 to -1.4) over 30 months. For both outcomes, the average difference between arms was greatest at 12th- and 18th-month time points. These differences remained when the analysis was stratified by post-school education. CONCLUSIONS: Women with low-grade cytology, irrespective of their management, have substantial initial psychosocial morbidity that reduces over time. Implementation of newer screening strategies, which include surveillance, such as primary HPV screening, need to consider the information and support provided to women. © 2016 The Authors. Psycho-Oncology published by John Wiley & Sons Ltd.

UK Lung Cancer RCT Pilot Screening Trial: baseline findings from the screening arm provide evidence for the potential implementation of lung cancer screening.

BACKGROUND: Lung cancer screening using low-dose CT (LDCT) was shown to reduce lung cancer mortality by 20% in the National Lung Screening Trial. METHODS: The pilot UK Lung Cancer Screening (UKLS) is a randomised controlled trial of LDCT screening for lung cancer versus usual care. A population-based questionnaire was used to identify high-risk individuals. CT screen-detected nodules were managed by a pre-specified protocol. Cost effectiveness was modelled with reference to the National Lung Cancer Screening Trial mortality reduction. RESULTS: 247 354 individuals aged 50-75 years were approached; 30.7% expressed an interest, 8729 (11.5%) were eligible and 4055 were randomised, 2028 into the CT arm (1994 underwent a CT). Forty-two participants (2.1%) had confirmed lung cancer, 34 (1.7%) at baseline and 8 (0.4%) at the 12-month scan. 28/42 (66.7%) had stage I disease, 36/42 (85.7%) had stage I or II disease. 35/42 (83.3%) had surgical resection. 536 subjects had nodules greater than 50 mm(3) or 5 mm diameter and 41/536 were found to have lung cancer. One further cancer was detected by follow-up of nodules between 15 and 50 mm(3) at 12 months. The baseline estimate for the incremental cost-effectiveness ratio of once-only CT screening, under the UKLS protocol, was £8466 per quality adjusted life year gained (CI £5542 to £12 569). CONCLUSIONS: The UKLS pilot trial demonstrated that it is possible to detect lung cancer at an early stage and deliver potentially curative treatment in over 80% of cases. Health economic analysis suggests that the intervention would be cost effective-this needs to be confirmed using data on observed lung cancer mortality reduction. TRIAL REGISTRATION: ISRCTN 78513845.

Cost-effectiveness of volar locking plate versus percutaneous fixation for distal radial fractures: Economic evaluation alongside a randomised clinical trial.

This study compares the cost-effectiveness of treating dorsally displaced distal radial fractures with a volar locking plate and percutaneous fixation. It was performed from the perspective of the National Health Service (NHS) using data from a single-centre randomised controlled trial. In total 130 patients (18 to 73 years of age) with a dorsally displaced distal radial fracture were randomised to treatment with either a volar locking plate (n = 66) or percutaneous fixation (n = 64). The methodology was according to National Institute for Health and Care Excellence guidance for technology appraisals. . There were no significant differences in quality of life scores between groups at any time point in the study. Both groups returned to baseline one year post-operatively. NHS costs for the plate group were significantly higher (p < 0.001, 95% confidence interval 497 to 930). For an additional £713, fixation with a volar locking plate offered 0.0178 additional quality-adjusted life years in the year after surgery. The incremental cost-effectiveness ratio (ICER) for plate fixation relative to percutaneous fixation at list price was £40 068. When adjusting the prices of the implants for a 20% hospital discount, the ICER was £31 898. Patients who underwent plate fixation did not return to work earlier. We found no evidence to support the cost-effectiveness, from the perspective of the NHS, of fixation using a volar locking plate over percutaneous fixation for the operative treatment of a dorsally displaced radial fracture.

Cost comparison of re-usable and single-use fibrescopes in a large English teaching hospital.

A number of studies in the U.S.A. and mainland Europe have described the costs of fibreoptic tracheal intubation. However, no such data from the UK appear available. We performed a cost assessment of fibreoptic intubation, using re-usable (various devices from Olympus, Acutronic and Karl Storz) and single-use (Ambu aScope) fibrescopes, at the Queens Medical Centre, Nottingham, U.K., between 1 January 2009 and 31 March 2014. The total annual cost of fibreoptic intubation with re-usable fibrescopes was £46,385. Based on 141 fibreoptic intubations per year, this equated to £329 per use, an average dominated by repair/maintenance costs (43%) and capital depreciation costs (42%). In comparison, the total annual cost of using single-use fibrescopes for the same work would have been around £200 per use. The analysis enabled us to develop a generic model, wherein we were able to describe the relationship between total cost of use vs number of uses for a fibrescope. An 'isopleth' was identified for this relationship: a line that joined all the points where the cost of re-usable vs single-use fibrescopes was equal. It appears cheaper to use single-use fibrescopes at up to 200 fibreoptic intubations per year (a range commensurate with normal practice) even when the repair rate for re-usable fibrescopes is low. Any centre, knowing its fibrescope use and repair rate, can plot its data similarly to help ascertain which of the re-usable or single-use fibrescope represents better value.

A normal colposcopy examination fails to provide psychological reassurance for women who have had low-grade abnormal cervical cytology.

OBJECTIVE: Worldwide, each year, large numbers of women are referred for colposcopy following low-grade abnormal cervical cytology. Many have no visible abnormality on examination. The risk of cervical intra-epithelial neoplasia grade 2/3 (CIN2/3) in these women is low. It is unknown whether, for women, a normal colposcopy resolves the anxiety which often follows the receipt of an abnormal cytology result. We investigated the prevalence of adverse psychological outcomes over 30 months following a normal colposcopy. METHODS: This cohort study was nested within the UK TOMBOLA randomized controlled trial. Women aged 20-59 years, with recent low-grade cytology, who had a satisfactory colposcopy examination and normal transformation zone, completed the Hospital Anxiety and Depression Scale (HADS) and Process Outcome Specific Measure (POSM) at recruitment and during follow-up (12, 18, 24 and 30 months post-recruitment). Outcomes included percentages reporting significant anxiety (HADS anxiety subscale score ≥11), significant depression (HADS depression subscale score ≥8) or worries about the result of the next cytology test, cervical cancer, having sex, future fertility and general health at each time point (point prevalence) and during follow-up (cumulative prevalence). RESULTS: The study included 727 women. All psychological measures (except depression) had high prevalence at recruitment, falling substantially by 12 months. During follow-up, the cumulative prevalence of significant anxiety was 27% and significant depression was 21%. The most frequently reported worry was that the next cytology test would be abnormal (cumulative prevalence of 71%; point prevalence of ≥50% at 12 and 18 months). The cumulative prevalence values of worries about cervical cancer, having sex and future fertility were 33%, 20% and 16%, respectively. CONCLUSIONS: For some women who have low-grade cytology, a normal colposcopy does not appear to provide psychological reassurance.

Evaluation of mammographic surveillance services in women aged 40-49 years with a moderate family history of breast cancer: a single-arm cohort study.

BACKGROUND: Women with a significant family history of breast cancer are often offered more intensive and earlier surveillance than is offered to the general population in the National Breast Screening Programme. Up to now, this strategy has not been fully evaluated. OBJECTIVE: To evaluate the benefit of mammographic surveillance for women aged 40-49 years at moderate risk of breast cancer due to family history. The study is referred to as FH01. DESIGN: This was a single-arm cohort study with recruitment taking place between January 2003 and February 2007. Recruits were women aged < 50 years with a family history of breast or ovarian cancer conferring at least a 3% risk of breast cancer between ages 40 and 49 years. The women were offered annual mammography for at least 5 years and observed for the occurrence of breast cancer during the surveillance period. The age group 40-44 years was targeted so that they would still be aged < 50 years after 5 years of surveillance. SETTING: Seventy-four surveillance centres in England, Wales, Scotland and Northern Ireland. PARTICIPANTS: A total of 6710 women, 94% of whom were aged < 45 years at recruitment, with a family history of breast cancer estimated to imply at least a 3% risk of the disease between the ages of 40 and 50 years. INTERVENTIONS: Annual mammography for at least 5 years. MAIN OUTCOME MEASURES: The primary study end point was the predicted risk of death from breast cancer as estimated from the size, lymph node status and grade of the tumours diagnosed. This was compared with the control group from the UK Breast Screening Age Trial (Age Trial), adjusting for the different underlying incidence in the two populations. RESULTS: As of December 2010, there were 165 breast cancers diagnosed in 37,025 person-years of observation and 30,556 mammographic screening episodes. Of these, 122 (74%) were diagnosed at screening. The cancers included 44 (27%) cases of ductal carcinoma in situ. There were 19 predicted deaths in 37,025 person-years in FH01, with an estimated incidence of 6.3 per 1000 per year. The corresponding figures for the Age Trial control group were 204 predicted deaths in 622,127 person-years and an incidence of 2.4 per 1000 per year. This gave an estimated 40% reduction in breast cancer mortality (relative risk = 0.60; 95% confidence interval 0.37 to 0.98; p = 0.04). CONCLUSIONS: Annual mammography in women aged 40-49 years with a significant family history of breast or ovarian cancer is both clinically effective in reducing breast cancer mortality and cost-effective. There is a need to further standardise familial risk assessment, to research the impact of digital mammography and to clarify the role of breast density in this population. TRIAL REGISTRATION: National Research Register N0484114809. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 11. See the HTA programme website for further project information.

Responsiveness of the EQ-5D health-related quality-of-life instrument in assessing low back pain.

OBJECTIVE: To compare the responsiveness of the EuroQol five-dimensional questionnaire (EQ-5D) generic quality-of-life instrument with that of specific instruments-the Brief Pain Inventory (BPI) and the Oswestry Disability Index (ODI)-in assessing low back pain. METHODS: Data were obtained from a group of patients receiving epidural steroid injections. We assessed responsiveness by using correlation, by estimating standardized response means, by receiver operating characteristic curve analysis, and by comparing the minimum clinically important differences peculiar to each of the instruments. RESULTS: ODI, BPI, and EQ-5D index scores, and changes in scores, were found to be correlated. Estimated standardized response means and receiver operating characteristic curve analysis suggested lower responsiveness for the EQ-5D index score. Clinically significant categories of mild, moderate, and severe BPI pain intensity translated into progressively and significantly lower mean EQ-5D index scores. An increase or a decrease in severity level reported on any of the five EQ-5D dimensions was associated with significant changes (with appropriate signs) in the condition-specific scores. No change in severity in any EQ-5D dimension was associated with no change in the specific scores. Significant changes in the EQ-5D index scores were associated with clinically important changes in the ODI and BPI scores. Correlation between index scores and responses on EQ-5D's visual analogue scale was only moderate. CONCLUSIONS: The EQ-5D index is less responsive than instruments specific to pain measurement, although it is capable of indicating clinically important changes. The lower responsiveness arises from EQ-5D's more limited gradation of severity and its multidimensionality.

Which women default from follow-up cervical cytology tests? A cohort study within the TOMBOLA trial.

OBJECTIVE: To identify factors associated with default from follow-up cervical cytology tests. METHODS: A cohort study was conducted involving 2166 women, aged 20-59, with recent low-grade cervical cytology taken within the NHS Cervical Screening Programmes in Scotland and England, and managed by 6-monthly cytology in primary care. For the first (6-month) and second (12-month) surveillance cytology tests separately, women were categorized as 'on-time attendees' (attended ≤6 months of test being due), 'late attendees' (attended greater than 6 months after test was due) or 'non-attendees' (failed to attend). Multivariate odds ratios (ORs) were computed for factors associated with late and non-attendance. RESULTS: For the first surveillance test, risk of non-attendance was significantly higher in younger women, those without post-secondary education, and non-users of prescribed contraception. Factors significantly associated with late attendance for the first test were the same as for non-attendance, plus current smoking and having children. The most important predictor of non-attendance for the second surveillance test was late attendance for the first test (OR = 9.65; 95% CI, 6.60-16.62). Non-attendance for the second test was also significantly higher among women who were younger, smokers and had negative cytology on the first surveillance test. Late attendance for the second surveillance test was higher in women who were younger, smokers, had children and attended late for the first test. CONCLUSIONS: Women at highest risk of default from follow-up cytology tend to be young, smoke, lack post-secondary education, and have defaulted from a previous surveillance appointment. Tackling default will require development of targeted strategies to encourage attendance and research to better understand the reasons underpinning default.

Nottingham trial of faecal occult blood testing for colorectal cancer: a 20-year follow-up.

BACKGROUND: Three large randomised trials have shown that screening for colorectal cancer (CRC) using the faecal occult blood test (FOBt) can reduce the mortality from this disease. The largest of these trials, conducted in Nottingham since 1981, randomised 152,850 individuals between the ages of 45 and 74 years to an intervention arm receiving biennial Haemoccult (FOB) test kit or to a control arm. In 2006, the National Bowel Cancer Screening Programme was launched in England using the FOBt, with the expectation that it will reduce CRC mortality. AIMS: To compare the CRC mortality and incidence in the intervention arm with the control arm after long-term follow-up. METHODS: The 152,850 randomised individuals were followed up through local health records and central flagging (Office for National Statistics). RESULTS: At a median follow-up of 19.5 years there was a 13% reduction in CRC mortality (95% CI 3% to 22%) in the intervention arm despite an uptake at first invitation of approximately 57%. The CRC mortality reduction in those accepting the first screening test, adjusted for the rate of non-compliers, was 18%. There was no significant difference in mortality from causes other than CRC between the intervention and control arms. Despite removing 615 adenomas >10 mm in size from the intervention arm, there was no significant difference in CRC incidence between the two arms. CONCLUSIONS: Although the reduction in CRC mortality was sustained, further follow-up of the screened population has not shown a significant reduction in the CRC incidence. Moreover, despite the removal of many large adenomas there was no reduction in the incidence of invasive cancer which was independent of sex and site of the tumour.

Long-term psychosocial impact of alternative management policies in women with low-grade abnormal cervical cytology referred for colposcopy: a randomised controlled trial.

BACKGROUND: The debate continues regarding the best management for women with low-grade abnormal cervical cytology attending colposcopy. We compared psychosocial outcomes of alternative management policies in these women. METHODS: In all, 989 women, aged 20-59 years, with low-grade abnormal cytology, were randomised to immediate large loop excision (LLETZ) or two to four targeted punch biopsies taken immediately with recall for LLETZ if these showed cervical intra-epithelial neoplasia 2/3. At 6 weeks after the last procedure, women completed the hospital anxiety and depression scale (HADS) and the impact of event scale (IES). At 12, 18, 24 and 30 months post recruitment, women completed the HADS and process outcome specific measure (POSM). Prevalence of significant depression (≥ 8), significant anxiety (≥ 11) and distress (≥ 9) and median POSM scores were compared between arms. Multivariate odds ratios (ORs) for immediate LLETZ vs biopsy and recall were computed. RESULTS: Over the entire follow-up, there was no significant difference between arms in cumulative prevalence or risk of significant depression (OR=0.78, 95% CI 0.52-1.17) or significant anxiety (OR=0.83, 95% CI 0.57-1.19). At 6 weeks post procedure, distress did not differ significantly between arms. At later time points, 8-11% had significant depression and 14-16% had significant anxiety but with no differences between arms. The POSM scores did not differ between the arms. CONCLUSIONS: There is no difference in long- or short-term psychosocial outcomes of immediate LLETZ and punch biopsies with selective recall.

Analysis of deaths occurring within the Nottingham trial of faecal occult blood screening for colorectal cancer.

OBJECTIVE: To report the causes of, and ages at, death of subjects in an English colorectal cancer screening trial. DESIGN AND SETTING: Analysis of 78 708 deaths occurring between 1981 and 2008, within the Nottingham randomised controlled trial of biennial faecal occult blood testing. MAIN OUTCOME MEASURES: Cause of death, age at death by sex and by cause. RESULTS: Significantly more subjects died from verified colorectal cancer in the trial's control group than in the intervention group (3.2% vs 2.9%). For no other major cause of death was the difference in proportion across the two groups statistically significant. Age at death was lower for cancer than for other principal causes, except for ischaemic heart disease among women. However, mean age at death was higher for colorectal cancer than for other cancers, except for prostate cancer among men. Increasing levels of material deprivation significantly lowered the expected ages at death, independently of cause. For both men and women, the mean age at death from all causes for screening participants was higher than that of controls and non-participants. Mean deprivation was lowest among participants. Of those participating in screening, and dying from colorectal cancer, subjects receiving negative test results lived significantly longer than those who received positive test results. However, if dying from other causes, they died at an earlier age. CONCLUSIONS: The age at death from colorectal cancer is higher than that of most other cancers. Those accepting a screening invitation live longer than non-participants. In part, this difference is explained by relative deprivation. Among screening participants, the receipt of a positive, as opposed to a negative, test result is associated with a later age at death.

Prospective randomized trial using cost-utility analysis of early versus delayed laparoscopic cholecystectomy for acute gallbladder disease.

BACKGROUND: This randomized controlled trial compared the cost-utility of early laparoscopic cholecystectomy with that for conventional management of newly diagnosed acute gallbladder disease. METHODS: Adults admitted to hospital with a first episode of biliary colic or acute cholecystitis were randomized to an early intervention group (36 patients, operation within 72 h of admission) or a conventional group (36, elective cholecystectomy 3 months later). Costs were measured from a National Health Service and societal perspective. Quality-adjusted life year (QALY) gains were calculated 1 month after surgery. RESULTS: The mean(s.d.) total costs of care were pound 5911(2445) for the early group and pound 6132(3244) for the conventional group (P = 0.928), Mean(s.d.) societal costs were pound 1322(1402) and pound 1461(1532) for the early and conventional groups respectively (P = 0.732). Visual analogue scale scores of health were 72.94 versus 84.63 (P = 0.012) and the mean(s.d.) QALY gain was 0.85(0.26) versus 0.93(0.13) respectively (P = 0.262). The incremental cost per additional QALY gained favoured conventional management at a cost of pound 3810 per QALY gained. CONCLUSION: In this pragmatic trial, the cost-utilities of both the early and conventional approaches were similar, but the incremental cost per additional QALY gained favoured conventional management.

Hospital costs of colorectal cancer care.

OBJECTIVE: In a hospital based setting, identify factors which influence the cost of colorectal cancer care? DESIGN: Retrospective case note review SETTING: Nottingham, United Kingdom PARTICIPANTS: 227 patients treated for colorectal cancer METHODS: Retrospective review of the hospital records provided the primary data for the costing study and included all CRC related resource consumption over the study period. RESULTS: Of 700 people identified, 227 (32%) sets of hospital notes were reviewed. The median age of the study group was 70.3 (IQR 11.3) years and there were 128 (56%) males. At two years, there was a significant difference in costs between Dukes D cancers ( pound3641) and the other stages ( pound3776 Dukes A; pound4921 Dukes B). Using univariate and multivariate regression, the year of diagnosis, Dukes stage of disease, intensive nursing care, stoma requirements and recurrent disease all significantly affected the total cost of care. CONCLUSIONS: CRC remains costly with no significant difference in costs if diagnosed before compared to after 1992. Very early and very late stage cancers remain the least costly stage of cancers to treat. Other significant effectors of hospital costs were the site of cancer (rectal), intensive nursing care, recurrent disease and the need for a stoma.

Population screening for colorectal cancer: the implications of an ageing population.

Population screening for colorectal cancer (CRC) has recently commenced in the United Kingdom supported by the evidence of a number of randomised trials and pilot studies. Certain factors are known to influence screening cost-effectiveness (e.g. compliance), but it remains unclear whether an ageing population (i.e. demographic change) might also have an effect. The aim of this study was to simulate a population-based screening setting using a Markov model and assess the effect of increasing life expectancy on CRC screening cost-effectiveness. A Markov model was constructed that aimed, using a cohort simulation, to estimate the cost-effectiveness of CRC screening in an England and Wales population for two timescales: 2003 (early cohort) and 2033 (late cohort). Four model outcomes were calculated; screened and non-screened cohorts in 2003 and 2033. The screened cohort of men and women aged 60 years were offered biennial unhydrated faecal occult blood testing until the age of 69 years. Life expectancy was assumed to increase by 2.5 years per decade. There were 407 552 fewer people entering the model in the 2033 model due to a lower birth cohort, and population screening saw 30 345 fewer CRC-related deaths over the 50 years of the model. Screening the 2033 cohort cost pound 96 million with cost savings of pound 43 million in terms of detection and treatment and pound 28 million in palliative care costs. After 30 years of follow-up, the cost per life year saved was pound 1544. An identical screening programme in an early cohort (2003) saw a cost per life year saved of pound 1651. Population screening for CRC is costly but enables cost savings in certain areas and a considerable reduction in mortality from CRC. This Markov simulation suggests that the cost-effectiveness of population screening for CRC in the United Kingdom may actually be improved by rising life expectancies.

Management of low-grade cervical abnormalities detected at screening: which method do women prefer?

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.

Treated Colorectal Cancer: What is the Cost to Primary Care?

BACKGROUND: Colorectal cancer is the second commonest cause of cancer death and the cost to primary care has not been estimated. AIM: To determine the direct primary care costs of colorectal cancer care. DESIGN: Retrospective case note review. SETTING: Nottingham, United Kingdom. METHODS: We identified people with colorectal cancer between 1995 and 1998, from computerised pathology records. Colorectal cancer related resources consumed in primary care, from hospital discharge to death, were identified from retrospective notes review. Outcome measures were costs incurred by the General Practitioner (GP) and the total cost to primary care. We used multiple linear regression to identify predictors of cost. RESULTS: Of 416 people identified from pathology records, the median age at primary operation of the 135 (33%) people we selected was 74.2 (IQR 14.4) years, 75 (56%) were male. The median GP cost was: Dukes A pound61.0 (IQR 516.2) and Dukes D pound936.2 (1196.2) p < 0.01. The geometric mean ratio found Dukes D cancers to be 10 times as costly as Dukes A. The median total cost was: Dukes A pound1038.3 (IQR 5090.6) and Dukes D pound1815.2 (2092.5) p = 0.06. Using multivariate analysis, Dukes stage was the most important predictor of GP costs. For total costs, the presence of a permanent stoma was the most predictive variable, followed by adjuvant therapy and advanced Dukes stage (Dukes C and D). CONCLUSIONS: Contrary to hospital based care costs, late stage disease (Dukes D) costs substantially more to general practice than any other stage. Stoma care products are the most costly prescribable item. Costs savings may be realised in primary care by screening detection of early stage colorectal cancers.

Risk-stratified intensive follow up for treated colorectal cancer - realistic and cost saving?

OBJECTIVE: Intensive follow-up post surgery for colorectal cancer (CRC) is thought to improve long-term survival principally through the earlier detection of recurrent disease. This paper aims to calculate the additional resource and cost implications of intensive follow up post-CRC resection, examine the possibility of risk-stratifying this follow up to those at highest risk of recurrence and investigating the impact that population screening might have on the future cost and outcomes of follow up. METHOD: Two follow-up regimens were constructed: the 'standard' follow-up protocol used the principles of the British Society of Gastroenterology (BSG) guidelines whilst the 'intensive' follow-up protocol used the most intensive arm of the follow up after colorectal surgery (FACS) trial. Using ONS data, the number of CRC diagnosed in a given year was calculated for 2003 and projected for 2016 based on the population of England and Wales. The resource requirements and costs of follow up over a 5-year period were then calculated for the two time periods. Risk stratifying entry to follow up and the introduction of population CRC screening were then considered. RESULTS: For the 2003 cohort, an intensive follow-up program would detect 853 additional resectable recurrences over 5 years with 795 fewer subjects requiring palliative care. An additional 26 302 outpatient appointments, 181 352 CEA tests and 79 695 CT scans over 5 years would be required to achieve this. The cost of investigating subjects who would never develop detectable recurrences was pound15.6 million. The cost per additional resectable recurrence was pound18 077, a figure also found for a nonscreened population in 2016. An identical intensive follow-up policy with biennial FOBT screening in 2016 saw the cost per additional resectable recurrence rise to pound36 255. CONCLUSION: Intensive follow up will detect considerably more resectable recurrences but at considerable cost and it is unclear if such follow up will be achievable in an already over-stretched NHS. If population-based CRC screening increases the number of Dukes A cancers this may offer the possibility of risk-stratifying future follow up to those at highest risk of recurrence; minimizing tests on those who will never have recurrent disease and better utilizing our scarce resources.

Psychological effects of a low-grade abnormal cervical smear test result: anxiety and associated factors.

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.

Developing a questionnaire to measure the psychosocial impact of an abnormal cervical smear result and its subsequent management: the TOMBOLA (Trial of Management of Borderline and Other Low-grade Abnormal Smears) trial.

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.