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 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.

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.

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.

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.

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.

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.

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.

Estimating time and out-of-pocket costs incurred by families attending a pediatric cochlear implant programme.

OBJECTIVES: The objectives of this study are to estimate time and out-of-pocket costs incurred by families attending a pediatric cochlear implant programme. In addition, qualitative data examine the intangible costs faced by families. METHODS: Data was collected during semi-structured face-to-face interviews with parents of children with a cochlear implant attending a clinic visit at Nottingham Cochlear Implantation Programme (NPCIP), UK. Information supplied included socio-demographic characteristics, mode of travel, out-of-pocket expenses, time foregone, and details of companions. Quantitative data was stored and analysed in SPSS version 11.5. RESULTS: Two hundred and sixteen face-to-face interviews were conducted with parents of children implanted for between 1 month and 13 years. Time and out-of-pocket costs were significantly higher for those in the first 2 years of the programme, mean UK pound 3090 per annum compared to UK pound 2159 per annum for those in years >2-5 and UK pound 1815 per annum for those in years >5 (P<0.001). The biggest component of this was time costs, although the sensitivity analysis revealed that these were also most variable depending on the methods used to estimate them. The largest out-of-pocket cost incurred by families was travel costs which accounted for 44%, although 16% of families received some financial help with travel costs. The qualitative findings are consistent with these findings, also showing that over time the financial and intangible costs incurred as a result of cochlear implantation decline. CONCLUSIONS: This study is the first to obtain primary data on the time and out-of-pocket costs incurred by families attending a pediatric cochlear implant programme in the UK. It finds that these costs are greatest for those families in the first 2 years of the programme and/or who live furthest from the programme.

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.

Stage-specific treatment costs for cervical cancer in the United Kingdom.

In order to examine the relationship between stage at initial diagnosis and management costs for cervical cancer, a detailed cost audit over 5 years was conducted on a sample of patients diagnosed in 1990 in one U.K. region. The mean costs of managing pre-invasive carcinoma (386 Pounds) were found to be significantly lower than those of stage 1 invasive carcinoma (6623 Pounds) and both were lower than the costs of invasive cancer at stages 2-4 (10,910 Pounds, 10,579 Pounds and 11,035 Pounds, respectively). A comparison of management costs for cervical cancer with those of breast cancer by stage revealed both that the former are invariably higher and that the cost-by-stage profiles for the two diseases are dissimilar.

Early withdrawal from cervical cancer screening: the question of cost-effectiveness.

In countries such as the UK, mass population screening for cervical cancer has been undertaken since the 1960s. Although of established effectiveness, no formal evaluation of the screening protocol was carried out prior to its implementation. On the basis of a published mathematical modelling exercise, it has been speculated that withdrawing women from the screening programme at an earlier age than at present, whilst leading to a higher rate of invasive cervical cancer (ICC), could reduce resource use. Using estimates of screening and treatment costs, and of expected life-years lost following earlier withdrawal, we simulated cost-effectiveness ratios for various scenarios described by the model. Median cost savings resulting from a life-year lost never exceeded pound10000 for any scenario, although the estimates were particularly sensitive to the assumed age at cancer presentation and the rate of cancer progression. Our findings seem to offer little economic support for the early withdrawal of subjects from the cervical screening programme.

Willingness-to-pay for colorectal cancer screening.

Willingness-to-pay (WTP) techniques are increasingly being used in economic evaluation, as a means of assessing the value of new health care technologies. This paper presents the results of a WTP investigation of two types of screening for colorectal cancer. A questionnaire was issued to a general population via general practitioners (GPs), yielding a sample of approximately 2000 cases for analysis. Regression models demonstrated that WTP was significantly influenced by factors such as gender, income, age, risk perceptions, illness experiences and health beliefs. The median WTP for screening emerged as being pound30 or pound50, depending on the method used to elicit WTP, but independent of the screening protocol. Combining the results with those from related research, it emerged, first, that WTP subjects offered higher values for flexible sigmoidoscopy screening than the costs actually incurred by revealed preference studies and, second, they offered WTP values similar to the likely resource costs of the screening procedures.

The hospital costs of diagnostic procedures for colorectal cancer.

Diagnosis for colorectal cancer is commonly made using either colonoscopy or double contrast barium enema techniques. To data, little attention has been paid to the comparative costs of these two procedures and the paper presents estimates of hospital costs for each, using data from the colorectal study being undertaken in Nottingham, U.K. Consideration is also given to procedure sensitivity and the frequency of referral to the alternative technique in cases of incomplete diagnosis. The paper presents the conditions under which a given technique may be considered cost-superior to its alternative but concludes that the absence of conclusive clinical trial data and other considerations precludes the identification of a definitively optimum technique from the economic point of view.

Effect of subject age on costs of screening for colorectal cancer.

STUDY OBJECTIVE: The aim was to estimate costs and yields of faecal occult blood screening and rescreening for colorectal cancer, for differing age cohorts. DESIGN: Cost and clinical data were used as the basis for modelling the expected costs, and cost savings, resulting from the treatment of screen detected cancers, as compared with cancers detected by symptomatic presentation. SETTING: Data were derived from the MRC screening trial currently in progress in Nottingham. PARTICIPANTS: Approximately 140,000 subjects, age 50-79 years, were randomly allocated to a test (screened) and a control (unscreened) group. MAIN RESULTS: The net costs of detecting and treating a cancer following colorectal screening fall as the age of the target population increases, owing principally to the increasing incidence of the disease with age. Generally, the marginal detection and treatment costs falls for all age groups with the first screening round, but rises considerably with the second. If allowance is made for cancers prevented as a result of early detection and excision of adenomas, the costs of screening are substantially reduced for all age groups. CONCLUSIONS: Assuming a cost per QALY (quality adjusted life year gained) equivalent to that derived for the breast cancer screening programme, and a QALY gain from colorectal screening of one year, three screens, each separated by two years, appear economically justified for populations aged 60 years and above. Expected gains from cancer prevention make two screens justifiable for those between 45 and 59 years of age.

The cost of screening for colorectal cancer.

STUDY OBJECTIVE: The aim was to make projections of the likely costs and yield resulting from the implementation of a faecal occult blood screening programme for colorectal cancer. DESIGN: Cost and clinical data were derived from the MRC colorectal screening trial currently in progress in Nottingham, UK. SETTING: The above data were used as the basis for modelling the likely implications were the trial to be reproduced as a screening programme within a "typical" family practitioner committee area. MAIN RESULTS: For an average family practitioner committee area with a target population of 75,000 subjects aged 50-74 years, the initial screening round might be expected to detect 85 cancers at a total cost of approximately 250,000 pounds. This represents a cost per cancer detected of 2700 pounds and a cost per person screened of approximately 5 pounds. For subsequent screening rounds, total costs might be expected to fall although average costs are likely to remain approximately constant. CONCLUSIONS: The model is successful in generating "order of magnitude" estimates for the costs of implementation of a screening programme for colorectal cancer. As benefit estimates are not yet available, however, no cost-effectiveness analysis can be undertaken at this stage. In general, sensitivity analyses reveal that programme costs are more sensitive to changes in clinical variables, especially detection and compliance rates, than they are to variations in the costs of resource inputs. A screening programme with a more elaborate protocol than that currently employed in the Nottingham trial will entail considerable cost increases.

Optimal times of transfer between therapies: a mathematical framework.

This paper develops a mathematical framework for identifying optimal transfer times from a low-intensity, watchful waiting therapy to direct intervention. It allows for the probability that patients discharged from watchful waiting will suffer disease recurrence. Two specific functional forms for the resolution of the relevant medical condition are modeled (modified exponential and logistic). Initially structured as an expected cost minimisation problem, the analysis is extended to include the possibilities of differential benefits of the therapies and discounted cost and benefit valuations. The framework demonstrates the existence of non-synchronous transfer optima.

Participation and screening programmes for colorectal cancer: more would be better?

In clinical terms, a screening compliance rate of 100% may be deemed optimal in that the number of abnormalities detected is thereby maximized. This paper explores optimum compliance rates from the cost-effectiveness point of view by modelling the individual's decision to participate in the screening programme. Using data derived from contemporary colorectal screening trials, it assesses the compliance and cost effects of utilizing differing methods of screening invitation, and explores the incremental cost and benefits associated with compliance enhancement techniques. Given the estimated costs and benefits, attempts to attain higher levels of compliance would appear justifiable.