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A clinical and economic evaluation of endoscopic ultrasound for patients at risk for familial pancreatic adenocarcinoma |
Rubenstein J H, Scheiman J M, Anderson M A |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology The study compared four clinical management strategies for patients with a history of family members with pancreatic adenocarcinoma. The strategies considered were: prophylactic total pancreatectomy (PTP), annual surveillance by endoscopic ultrasound surveillance (EUS), annual surveillance with endoscopic ultrasound followed by fine-needle aspiration for pancreatic cancer (EUS/FNA), and do nothing. Economic study type Cost-effectiveness analysis, cost-utility analysis Study population The study population comprised a hypothetical cohort of asymptomatic men aged 45 years old from familial pancreatic cancer kindreds who had at least one first-degree relative with pancreatic cancer. Setting The clinical setting of the study was inpatient and outpatient care. The economic study was conducted in the USA. Dates to which data relate The effectiveness and resource use data were taken from studies published between 1990 and 2005. The price year was 2005.
Modelling A Markov model with a time horizon of 45 years was developed. A simplified graphical representation of the model was provided. Other details of the model, such as the health states and transition probabilities, were reported in the paper but the cycle length was not. Study designs and other criteria for inclusion in the review The clinical data used in the economic evaluation included EUS test characteristics for cancer in the setting of chronic pancreatitis; complications (mortality rates resulting from the screening techniques); the incidence of pancreatic cancer in the general and study population; and the mortality rates resulting from local, regional and distant cancer. Sources searched to identify primary studies The clinical data used in economic evaluation were derived from the published literature. No information on the design and other characteristics of the primary studies was reported. Due to the lack of relevant data on the accuracy of EUS, its sensitivity and specificity were based on author consensus. Methods used to derive estimates of effectiveness A systematic review of the literature was undertaken in order to identify relevant studies with which to inform model parameters. Although the search strategy was described in full, no inclusion or exclusion criteria were reported. Measure of benefits used in the economic analysis The measures of health benefit used were life expectancy, and quality-adjusted life-years (QALYs). Utility weights were derived from the published literature but they were not reported. Utility estimates for patients undergoing PTP were based on authors' assumptions. The health benefits were discounted at an annual rate of 3%. Direct costs The direct health care costs of the third-party health care payer were included in the analysis. The resource use data were taken from the model described above. The unit costs were not presented separately from the resource quantities. The costs were estimated from published studies and from the Centers for Medicare and Medicaid Services. The costs were adjusted to 2005 US dollars using an inflation rate of 3%. As with the benefits, the costs were discounted at an annual rate of 3% per annum. The price year was 2005. Statistical analysis of costs No statistical analysis of the resource use or cost data was undertaken as the costs were treated as point estimates (i.e. the data were deterministic). Indirect Costs No productivity costs were included in the analysis. Sensitivity analysis A series of one-way and two-way sensitivity analyses were conducted in order to determine the impact on the results of changing the model parameters. It would appear that only effectiveness parameters were evaluated in the sensitivity analyses. Estimated benefits used in the economic analysis The health benefits were:
for do nothing, 29.19 life-years and 18.57 QALYs;
for EUS/FNA, 28.26 life-years and 17.94 QALYs;
for EUS, 24.78 life-years and 14.54 QALYs; and
for PTP, 24.65 life-years and 14.28 QALYs. Cost results The costs were:
for do nothing, $2,983;
for EUS/FNA, $42,521;
for EUS, $186,089; and
for PTP, $199,911. Synthesis of costs and benefits The costs and benefits were combined using an incremental cost-effectiveness ratio (i.e. the additional cost per additional QALY). However, these were not reported as the do nothing strategy was dominant (i.e. more efficient and less costly) in comparison with the other three strategies. Authors' conclusions The authors concluded that first-degree relatives from familial pancreatic cancer kindreds, who have EUS findings of chronic pancreatitis, have increased lifetime risk for cancer. As this precise risk is unknown, these individuals should not undergo screening, unless as part of a research programme. Future research should be directed at methods which characterise and define the lifetime risk of pancreatic cancer. CRD COMMENTARY - Selection of comparators This study compared four management strategies for people with a family history of pancreatic cancer. You should consider whether they are valid comparators in your own setting. Validity of estimate of measure of effectiveness The model parameters were taken from published research. Although a number of model parameters were taken from more than one source, it was unclear how the data were combined. The authors reported that a systematic review of the literature was undertaken to identify relevant studies, and provided details of their search criteria. However, they did not specify their inclusion criteria. Since the authors did not provide details of the study designs in the paper, it is difficult to assess the internal validity of the sources used. Validity of estimate of measure of benefit The estimation of health benefit was appropriately derived from the model. The use of QALYs as the summary benefit measure was appropriate as they capture the impact of the intervention on two key dimensions of health (i.e. survival and quality of life). Furthermore, the choice of QALYs will permit the results of this study to be compared with those from other health care interventions. Validity of estimate of costs The analysis of the costs was consistent with the perspective of a third-party health care payer, and all relevant costs appear to have been included. A breakdown of the unit costs was provided in the paper. Future costs were appropriately discounted. However, uncertainty surrounding the cost data might not have been examined, as it appears that only effectiveness parameters were evaluated in the sensitivity analyses. The price year was reported, which will enable future reflation exercises. Other issues The authors do not appear to have presented their results selectively and their conclusions reflected the scope of their analysis. They compared their findings with those from other similar studies and suggested reasons for any differences. The results of this study were intended to be representative of the USA, and no attempt to apply the findings to other countries was made and the issue of generalisability to other settings was not addressed. The authors acknowledged a number of limitations to their study, such as the lack of available data to populate the model and the consequent assumptions that had to be made. Implications of the study The authors indicated the need for further research into the exact risk factors for familial pancreatic cancer and recommended that asymptomatic people with a familial history of pancreatic cancer should not be screened, as the results do not alter management and could potentially cause substantial harm. Source of funding Supported by the GlaxoSmithKline Institute for Digestive Health and the American Society for Gastrointestinal Endoscopy. Bibliographic details Rubenstein J H, Scheiman J M, Anderson M A. A clinical and economic evaluation of endoscopic ultrasound for patients at risk for familial pancreatic adenocarcinoma. Pancreatology 2007; 7(5-6): 514-525 Indexing Status Subject indexing assigned by NLM MeSH Adenocarcinoma /genetics /ultrasonography; Biopsy, Fine-Needle /economics; Decision Support Techniques; Endosonography /economics; Genetic Predisposition to Disease; Health Care Costs; Humans; Male; Markov Chains; Middle Aged; Pancreas /ultrasonography; Pancreatectomy /economics; Pancreatic Neoplasms /genetics /ultrasonography; Pancreatitis, Chronic /complications /therapy; Quality of Life; Risk AccessionNumber 22007002425 Date bibliographic record published 16/11/2007 Date abstract record published 09/08/2008 |
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