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32761. Helicobacter pylori test-and-treat intervention compared to usual care in primary care patients with suspected peptic ulcer disease in the United States Full Text available with Trip Pro

. A larger sample size would be needed to identify statistically significant differences in effectiveness outcomes. The answers to the questionnaire were obtained via telephone interviews, thus self-reported information was used. Most of the main outcome measures referred to treatment patterns rather than to health measures. The authors noted that, owing to the study design, it was not possible to determine how much the impact of the combined intervention could be attributed to the on-site test (...) . Source of funding Supported by an American Digestive Health Foundation/TAP Pharmaceuticals Outcomes Research Pilot Program Award; an unrestricted research grant from Astra Merck to the University of Michigan Gastroenterology Division; and the National Institutes of Health (grant M01-RR00079). Bibliographic details Ladabaum U, Fendrick A M, Glidden D, Scheiman J M. Helicobacter pylori test-and-treat intervention compared to usual care in primary care patients with suspected peptic ulcer disease

2002 NHS Economic Evaluation Database.

32762. Clinical and economic benefits of irinotecan in combination with 5-fluorouracil and folinic acid as first line treatment of metastatic colorectal cancer Full Text available with Trip Pro

, until death or trial cut-off date (median: 14.7 months; range: 11.5 - 21.1 months). It was not reported how the 62 patients included in the second stage of the study were chosen from those that failed first-line treatment in the alternative treatment arms. Analysis of effectiveness The authors reported that the basis for the analysis was intention to treat. The outcomes assessed for the first stage of the study and for both treatment arms (irinotecan plus 5-FU/FA and 5-FU/FA alone) were the response (...) that a small proportion of third-line treatment may have been included. The authors did not show that the groups were comparable at analysis, nor report how many patients were allocated in each one of the treatment arms in the second stage of the study. Effectiveness results The response rate with irinotecan plus 5-FU/FA (41%) was significantly higher than that with 5-FU/FA alone (23%), (p<0.001). The median time for disease progression was also significantly higher with irinotecan plus 5-FU/FA (6.7 months

2002 NHS Economic Evaluation Database.

32763. Prolonged treatment with interferon in patients with histologically mild chronic hepatitis C: a decision analysis

for 18 months versus no treatment were presented. This is misleading because it is the average of the incremental effect of 6 months versus no treatment and 18 months versus 6 months, the former generally being more cost-effective than the latter. You as the decision maker need to decide how much you are willing to pay for an increase in benefit. Implications of the study Longer treatment with interferon showed a survival and QALY benefit. The cost per QALY or LY seems reasonable compared (...) , for example, to the judgements of NICE, which seem to have a much higher threshold (about 30,000). As the authors stated, 'the results of this study provide some guidance as to the potential benefits of IFN treatment in patients with histologically mild disease.' They suggest that future models might include viral levels, presence of viral quasispecies and viral genotype when tests are available which provide better prediction of response. Source of funding Supported in part by unrestricted grants from

1998 NHS Economic Evaluation Database.

32764. [Prophylactic treatment of mood disorders: a cost-effectiveness analysis comparing lithium and carbamazepine]

was appropriate. Further details on the clinical trial could have strengthened the validity of the estimate of effectiveness. For example, the method used for randomisation, how blinding was conducted, the losses to follow-up, and the method used for the data analysis. Validity of estimate of costs In general, the costing was well conducted and sufficiently reported. All the categories of cost relevant to the perspective adopted were included in the analysis. In addition, for each category of cost, all (...) limitations. Implications of the study The authors recommended that lithium remain the 'gold' standard in the preventive treatment of unipolar and bipolar depressive episodes. Source of funding Supported by an educational grant from Merck KgaA. Bibliographic details Dardennes R, Lafuma A, Watkins S. Traitement preventif des troubles de l'humeur: comparaison cout-efficacite du lithium et de la carbamazepine. [Prophylactic treatment of mood disorders: a cost-effectiveness analysis comparing lithium

1999 NHS Economic Evaluation Database.

32765. Cost and outcome of mechanical ventilation for life-threatening stroke

-way sensitivity analysis was carried out in order to establish how sensitive both cost per life year and cost per QALY were to variations in different variables including: cost, survival, discounting, and utility variables. To test the plausible extremes of the variables within the model all such variables were adjusted to test the best and worse case scenarios. For the purpose of sensitivity analysis the discount rate was varied within the range 0% - 5%; justification for the range chosen (...) not receive absolutely no care. It also raises ethical issues, which might make this comparator inapplicable. Validity of estimate of measure of effectiveness Study physicians obtained effectiveness data prospectively through review of study sample medical records and neurological examination. The effectiveness measures chosen by authors allowed them to address the three main aims of the study: to determine how frequently stroke patients are mechanically ventilated; to identify predictors of 30-day

2000 NHS Economic Evaluation Database.

32766. Putting a lid on injury costs: the economic impact of the California motorcycle helmet law

to convert hospital charges into costs. The costs attributed to nursing home care were based on estimation rather than actual data due to unavailability. The date of the price data was 1993. Statistical analysis of costs The differences in medical expenditures were compared using the Kruskal-Wallis test and/or the Wilcoxon signed-rank test. Poisson regressions were performed, using injury and fatality rates as a proxy for costs, to determine how much of the decrease in costs was due to the helmet law (...) performed to account for the uncertainties in the data. The authors chose not to discount benefits and to discount costs at 3%. These discount rates might not apply in other countries. The issue of generalisability to other settings or countries was not addressed. Appropriate comparisons were made with other studies. Source of funding Funded by a grant from the California Office of Traffic Safety (MC9201). Bibliographic details Max W, Stark B, Root S. Putting a lid on injury costs: the economic impact

1998 NHS Economic Evaluation Database.

32767. Costs and effectiveness of alternative strategies for cervical cancer screening in military beneficiaries

, in the past, received unrestricted grant funding from Digene Inc. for the evaluation of economic issues surrounding human papillomavirus testing. Bibliographic details Maxwell G L, Carlson J W, Ochoa M, Krivak T, Rose G S, Myers E R. Costs and effectiveness of alternative strategies for cervical cancer screening in military beneficiaries. Obstetrics and Gynecology 2002; 100(4): 740-748 PubMedID Indexing Status Subject indexing assigned by NLM MeSH Adult; Cost-Benefit Analysis; Female; Health Care Costs

2002 NHS Economic Evaluation Database.

32768. Dialysis for end-stage renal disease: determining a cost-effective approach

analysis The effect of a three-way analysis on incremental cost-effectiveness ( per life-year) was presented. This varied the discount rates, costs and transition probabilities. The cost and probability values used were labelled as high or low. The corresponding resource quantities and unit costs were not given for the costs. It was not stated how the probabilities were combined to produce the high and low estimates. The discount rates were 0, 6 and 10%. Estimated benefits used in the economic analysis (...) to their observational nature. Also, only three studies were obtained, and it was not stated how the estimates from the studies were used to provide the probabilities used in the model. The assumption that the patients were only able to switch treatment because of complications does not take into account other reasons for switching. However, the magnitude of any effect this would cause is not known. Validity of estimate of measure of benefit The number of life-years gained was an appropriate measure of health

2001 NHS Economic Evaluation Database.

32769. The effectiveness of a home visit to prevent childhood injury

was representative of the study population. The patient groups were shown to differ at baseline, mainly due to the attrition of younger and less educated parents. It is unclear how this could have impacted on the analysis. The authors did not discuss the statistical analysis used to compare the costs. Validity of estimate of measure of benefit The measure of the benefit used in the economic analysis was injuries prevented, which was obtained directly from the effectiveness analysis. No justification was provided (...) to determine the most worthwhile or least beneficial components of the programme. "Future programmes should integrate with other home visitation programmes and target a few, well-focused, evidence-based areas including the evaluation of high-risk groups and the effect of repeated visits on outcome." Source of funding Supported by Health and Welfare Canada, National Health Research and Development Programme, grant number 6605-4290-BF. Bibliographic details King W J, Klassen T P, LeBlanc J, Bernard-Bonnin

2001 NHS Economic Evaluation Database.

32770. Will genetic testing alter the management of disease caused by infectious agents: a cost-effectiveness analysis of gene-testing strategies for prevention of rheumatic fever Full Text available with Trip Pro

of these studies still hold in current settings. When a base estimate of effectiveness was derived from multiple studies, the authors did not report how the results from the different studies were combined (if at all), or whether any differences between these studies were investigated. However, they did report that, if the estimate measures were uncertain, the value that tended to bias against genetic testing was used in the base-case scenario. Further, the authors appropriately varied measures (...) , careful attention to test development is needed so that test accuracy is optimised and the costs are limited. The authors stated that they expect similar strategies focusing on enhanced primary or secondary prophylaxis, according to knowledge of genetic testing, could also serve to limit disease caused by other chronic and recurrent infections. Source of funding Supported by the National Institutes of Health (grants A1-45473 and TW-00920). Bibliographic details King C H, Fischler D F, Gerkin R D

2002 NHS Economic Evaluation Database.

32771. The cost-effectiveness of infliximab (Remicade) in the treatment of rheumatoid arthritis in Sweden and the United Kingdom based on the ATTRACT study

grant from Schering Plough. Bibliographic details Kobelt G, Jonsson L, Young A, Eberhardt K. The cost-effectiveness of infliximab (Remicade) in the treatment of rheumatoid arthritis in Sweden and the United Kingdom based on the ATTRACT study. Rheumatology 2003; 42(2): 326-335 PubMedID Other publications of related interest Maini R, the ATTRACT Study Group. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant (...) costs and consequences of RA. Arthritis Rheum 2002;46:2310-9. Young A, Dixey J, Cox N, et al. How does functional disability in early rheumatoid arthritis (RA) affect patients and their lives? Results from a 5 year follow-up in 732 patients from the Early RA study. Rheumatology 2000;39:603-3. Indexing Status Subject indexing assigned by NLM MeSH Adult; Aged; Antibodies, Monoclonal /economics /therapeutic use; Antirheumatic Agents /economics /therapeutic use; Arthritis, Rheumatoid /drug therapy

2003 NHS Economic Evaluation Database.

32772. Projected cost-effectiveness of statewide universal newborn hearing screening

to special education, vocational rehabilitation, assistive devices, medical costs of treating deaf children, and productivity losses were not reported separately from the costs. The authors made assumptions to estimate the costs, some of which were based on evidence, and performed sensitivity analyses to evaluate how robust the results were when these assumptions were modified. Discounting was performed using a 3% discount rate. This was appropriate given that the study was performed in the USA (...) , but also on the ability to ensure follow-up of infants who do not pass screening tests. The authors recommend further research to measure the utilities of deaf children and adults given early or late identification and normal or delayed language abilities, as well as parental utilities concerning hearing screening test results. There is also a need to obtain better evidence about how early intervention affects the language, educational and vocational costs, and lifetime productivity of deaf individuals

2002 NHS Economic Evaluation Database.

32773. Economic benefits of establishing a National Cancer Center in Louisiana

searched to identify primary studies Not applicable. Criteria used to ensure the validity of primary studies Not applicable. Methods used to judge relevance and validity, and for extracting data Not applicable. Number of primary studies included It was unclear how many sources of information were included in the study. Methods of combining primary studies Not applicable. Investigation of differences between primary studies Not applicable. Results of the review The number of cancer deaths in Louisiana (...) in the economic analysis The measures of benefits used were the deaths averted, the disability-adjusted life-years (DALYs) saved and monetary benefits. Deaths averted by the NCI-designated centre were calculated by subtracting the 50th percentile cancer death levels from the current levels. DALYs were derived using data from the World Health Organization and, apparently, authors' assumptions. However, it was unclear how the authors estimated the number of DALYs saved per cancer death as a result of the NCI

2003 NHS Economic Evaluation Database.

32774. A cost consequence study of the impact of a dermatology-trained practice nurse on the quality of life of primary care patients with eczema and psoriasis

that the annual cost of the dermatology clinic was 2,208 and the annual potential saving in GP consultations was 504. The cost of training the practice nurse was 1,392 and the training implications for the hospital dermatology nurse was 384. Synthesis of costs and benefits Costs and benefits were not combined. Authors' conclusions This study demonstrates the difficulties of obtaining relevant information to facilitate decisions on how resources should be allocated in primary care. CRD COMMENTARY - Selection (...) . Implications of the study The authors believe that not all questions can be answered by large multi-centred trials and that studies themselves have an opportunity cost, consuming resources that could otherwise be spent on direct health care. Often, local resource decisions are based on partial evidence-yielding solutions that are satisfactory rather than optimal but which are, nevertheless, better than decisions taken with no evidence at all. Source of funding Funded with a grant of 7,500 from Leo

2000 NHS Economic Evaluation Database.

32775. Impact of new treatments for neonatal pulmonary hypertension on extracorporeal membrane oxygenation use and outcome

. No power calculations were performed and there is no evidence that the patient sample was appropriate for the clinical study question. In terms of patient numbers, it was not clear how many patients were included in period 1, but it was stated that there were 96 in period 2. Study design This study was a before and after study, based on retrospective case review, which took place at a single specialist ECMO centre. Patients were followed up until hospital discharge. Analysis of effectiveness (...) of experience. Implications of the study A randomised controlled trial is needed to validate the findings presented. Source of funding Supported in part by grant HL-46481 from the National Institute of Health and by the Bugher Physician-Scientist Training Program. Bibliographic details Kennaugh J M, Kinsella J P, Abman S H, Hernandez J A, Moreland S G, Rosenberg A A. Impact of new treatments for neonatal pulmonary hypertension on extracorporeal membrane oxygenation use and outcome. Journal of Perinatology

1997 NHS Economic Evaluation Database.

32776. Effects of decision aids for menorrhagia on treatment choices, health outcomes, and costs: a randomized controlled trial

was requested. In total, 1,301 eligible women were invited between October 1996 and February 1998 to participate in the study. Of these, 407 (31%) refused consent and did not participate in the study. The authors reported that there was no significant difference in age between those granting consent (mean age 40 years, standard deviation, SD=7.0) and those who refused (mean age 41 years, SD=7.7), (p=0.56). The reasons for refusal were not reported. Post-randomisation no patients were excluded for any reason (...) of funding Supported by a grant from the UK National Health Service Research and Development Health Technology Assessment Programme. The Health Economics Research Group receives funding from the UK Department of Health. Bibliographic details Kennedy A D M, Sculpher M J, Coulter A, Dwyer N, Rees M, Abrams K R, Horsley S, Cowley D, Kidson C, Kirwin C, Naish C, Stirrat G. Effects of decision aids for menorrhagia on treatment choices, health outcomes, and costs: a randomized controlled trial. JAMA 2002; 288

2002 NHS Economic Evaluation Database.

32777. A comprehensive comparison of Ziehl-Neelsen and fluorescence microscopy for the diagnosis of tuberculosis in a resource-poor urban setting

, with high numbers of suspects and high prevalence of HIV, the authors recommended the use of FM on two specimens. Source of funding Supported by a grant from the Netherlands Ministry of Development Co-operation. Bibliographic details Kivihya-Ndugga L E, van Cleeff M R, Githui W A, Nganga L W, Kibuga D K, Odhiambo J A, Klatser P R. A comprehensive comparison of Ziehl-Neelsen and fluorescence microscopy for the diagnosis of tuberculosis in a resource-poor urban setting. International Journal (...) of Tuberculosis and Lung Disease 2003; 7(12): 1163-1171 PubMedID Other publications of related interest Ba F, Rieder HL. A comparison of fluorescence microscopy with the Ziehl-Neelsen technique in the examination of sputum for acid-fast bacilli. International Journal of Tuberculosis and Lung Disease 1999;3:1101-5. Hopewell PC. Tuberculosis control: how the world has changed since 1990 (editorial). Bulletin of the World Health Organization 2002;80:427. Indexing Status Subject indexing assigned by NLM MeSH

2003 NHS Economic Evaluation Database.

32778. Impact of a multidisciplinary day program on disease and healthcare costs in children and adolescents with severe asthma: a two-year follow-up study

has considerable resource implications bearing in mind how impressive the results appear to be. Further research needs to be carried out on how this type of shorter, multidisciplinary approach could be used in other settings and for other chronic illnesses. Source of funding Grant sponsor: NIH: Grant number: General Clinical Research Center Grant MO1 RR00051: Grant sponsor: Dr Scholl Foundation. Bibliographic details Bratton D L, Price M, Gavin L, Glenn K, Brenner M, Gelfand E W, Klinnert M D (...) was carried out on treatment completers only. The absence of a control group also affects the validity. The authors attempted to justify the lack of a control group by stating how difficult it would be to get an appropriate control group given the severe and complex nature of patients referred to their programme. No power calculations were provided to justify the size of the sample. Validity of estimate of measure of benefit No summary measure of benefit was provided due to the cost-consequences approach

2001 NHS Economic Evaluation Database.

32779. Use of Gen-Probe AccuProbe Group B streptococcus test to detect group B streptococci in broth cultures of vaginal-anorectal specimens from pregnant women: comparison with traditional culture method

of benefit The only information given about the study sample is that it consisted of pregnant women attending ante-natal care at certain primary care centres. It is not possible to say how representative this sample may have been. This factor would have no effect on the sensitivity and specificity results. However, the proportion of positive cases of GBS detected could be very different for a different study sample, which would influence the cost-effectiveness of the culture method relative to the probe (...) saving. Source of funding Supported in part by a grant from Gen-Probe Inc. Bibliographic details Bourbeau P P, Heiter B J, Figdore M. Use of Gen-Probe AccuProbe Group B streptococcus test to detect group B streptococci in broth cultures of vaginal-anorectal specimens from pregnant women: comparison with traditional culture method. Journal of Clinical Microbiology 1997; 35(1): 144-147 PubMedID Indexing Status Subject indexing assigned by NLM MeSH Bacterial Typing Techniques; Cell Culture Techniques

1997 NHS Economic Evaluation Database.

32780. Cost-minimization analysis of domiciliary antenatal fetal monitoring in high-risk pregnancies

were apparently calculated using actual resource use multiplied by 1993 prices although no details as to how resource use was estimated were provided. In-hospital costs included: nursing care; monitoring sessions; ultrasonography; laboratory tests; medication and dietary measures. The following hospital costs were estimated: outpatient visits; monitoring sessions; outpatient ultrasonography; outpatient laboratory tests; home monitoring sessions; home medication; primary care (home). Direct non (...) controlled trial, although power calculations demonstrated the trial to be of sufficient size. It is not clear how randomisation was undertaken as it was reported to be both on a 1:1 basis as well as by 'block randomisation'. Since outcomes were not shown to vary (although one should note that the Prechtl neurologic examination, the primary outcome, was unblinded) the study proceeded from the cost-minimisation standpoint. One could, however have obtained women's views as to the benefits of domiciliary

1997 NHS Economic Evaluation Database.

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