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  • Article
    Ward S, Kaltenthaler E, Cowan J, Brewer N.
    Health Technol Assess. 2003;7(32):1-93.
    OBJECTIVES: To evaluate the clinical and cost-effectiveness of capecitabine and tegafur with uracil (UFT/LV) as first-line treatments for patients with metastatic colorectal cancer, as compared with 5-fluorouracil/folinic acid (5-FU/FA) regimens.
    DATA SOURCES: Electronic databases, reference lists of relevant articles and sponsor submissions were also consulted.
    REVIEW METHODS: Systematic searches, selection against criteria and quality assessment were performed to obtain data from relevant studies. Costs were estimated through resource-use data taken from the published trials and the unpublished sponsor submissions. Unit costs were taken from published sources, where available. An economic evaluation was undertaken to compare the cost-effectiveness of capecitabine and UFT/LV with three intravenous 5-FU/LV regimens widely used in the UK: the Mayo, the modified de Gramont regimen and the inpatient de Gramont regimens.
    RESULTS: The evidence suggests that treatment with capecitabine improves overall response rates and has an improved adverse effect profile in comparison with 5-FU/LV treatment with the Mayo regimen, with the exception of hand-foot syndrome. Time to disease progression or death after treatment with UFT/LV in one study appears to be shorter than after treatment with 5-FU/LV with the Mayo regimen, although it also had an improved adverse effect profile. Neither capecitabine nor UFT/LV appeared to improve health-related quality of life. Little information on patient preference was available for UFT/LV, but there was indicated a strong preference for this over 5-FU/LV. The total cost of capecitabine and UFT/LV treatments were estimated at 2111 pounds and 3375 pounds, respectively, compared with the total treatment cost for the Mayo regimen of 3579 pounds. Cost estimates were also presented for the modified de Gramont and inpatient de Gramont regimens. These were 3684 pounds and 6155 pounds, respectively. No survival advantage was shown in the RCTs of the oral drugs against the Mayo regimen. Cost savings of capecitabine and UFT/LV over the Mayo regimen were estimated to be 1461 pounds and 209 pounds, respectively. Drug acquisition costs were higher for the oral therapies than for the Mayo regimen, but were offset by lower administration costs. Adverse event treatment costs were similar across the three regimens. It was inferred that there was no survival difference between the oral drugs and the de Gramont regimens. Cost savings of capecitabine and UFT/LV over the modified de Gramont regimen were estimated to be 1353 pounds and 101 pounds, respectively, and over the inpatient de Gramont regimen were estimated to be 4123 pounds and 2870 pounds, respectively.
    CONCLUSIONS: The results show that there are cost savings associated with the use of oral therapies. No survival difference has been proven between the oral drugs and the Mayo regimen. In addition, no evidence of a survival difference between the Mayo regimen and the de Gramont regimens has been identified. However, improved progression-free survival and an improved adverse event profile have been shown for the de Gramont regimen over the Mayo regimen. Further research is recommended into the following areas: quality of life data should be included in trials of colorectal cancer treatments; the place of effective oral treatments in the treatment of colorectal cancer, the safety mechanisms needed to ensure compliance and the monitoring of adverse effects; the optimum duration of treatment; the measurement of patient preference; and a phase III comparative trial of capecitabine and UFT/LV versus modified de Gramont treatment to determine whether there was any survival advantage and to collate the necessary economic data.
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  • Article
    Boland A, Dundar Y, Bagust A, Haycox A, Hill R, Mujica Mota R, Walley T, Dickson R.
    Health Technol Assess. 2003;7(15):1-136.
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  • Article
    Calvert N, Hind D, McWilliams RG, Thomas SM, Beverley C, Davidson A.
    Health Technol Assess. 2003;7(12):1-84.
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  • Article
    Bankhead CR, Brett J, Bukach C, Webster P, Stewart-Brown S, Munafo M, Austoker J.
    Health Technol Assess. 2003;7(42):1-92.
    OBJECTIVES: To carry out a systematic review to examine the effects of cholesterol, breast and cervical cancer screening on actual or intended health-promoting behaviours and health-related beliefs.
    DATA SOURCES: Eleven electronic databases (between 1980 and 2000).
    REVIEW METHODS: All English language studies that investigated the impact of cholesterol, breast and cervical screening programmes on health-promoting behaviours and beliefs were assessed for inclusion. The data extraction form and quality assessment criteria were developed using the NHS Centre for Reviews and Dissemination guidelines. Data were extracted and a non-quantitative synthesis was conducted. Reviewers categorised the outcomes into those that could be considered beneficial or detrimental to health. This categorisation was based on a value judgement that considered both statistical and clinical significance.
    RESULTS: The cholesterol studies used prospective designs more frequently, possibly as many focused on observing changes in lifestyle following screening. Participants who went for breast or cervical screening were not offered advice on lifestyle changes and most of the research into cancer screening programmes investigated issues related to uptake of screening services, explanations of why people are or are not screened and interventions to improve uptake. All three screening programmes are associated with high levels of favourable health behaviours and beliefs that have been measured, although there is evidence that recommended follow-up after screening is often not adhered to. There was no literature on the cost-effectiveness regarding the wider implications of screening (only on reduction of disease-specific mortality/morbidity), possibly due to the outcomes being very broad and not easily categorised and classified.
    CONCLUSIONS: The studies reviewed suggest that cholesterol screening had a positive effect on health behaviours, although participation was voluntary and those screened were possibly more motivated to make changes. These results are therefore not generalisable to the entire population and other factors need to be taken into account. Reduction in blood cholesterol levels was reported in all but two of the studies that assessed this outcome, suggesting that successful lifestyle changes were made. However, as most of the studies only reported follow-up of those screened, some of the reduction can be attributable to regression to the mean. Whether breast and cervical screening affect future health behaviours and beliefs has not been directly measured in many studies and few studies have collected baseline measures. However, evidence suggests that women who attend breast and cervical screening once are likely to reattend and attendance is associated with several positive health behaviours, although it cannot be confirmed whether the associations observed were a result of screening or because these women have a certain set of health behaviours and beliefs irrespective of their experience of screening. Areas of further research include: measuring a much wider range of behaviours and beliefs before and after screening is accepted or declined, examining the subgroup of participants who receive 'desirable' results and the impact of this on health beliefs and health-promoting behaviour, and qualitative research into the experiences of screening and how this interacts with knowledge and beliefs about other aspects of health.
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  • Article
    Moher D, Pham B, Lawson ML, Klassen TP.
    Health Technol Assess. 2003;7(41):1-90.
    OBJECTIVE: To assemble a large dataset of language restricted and language inclusive systematic reviews, including both conventional medicinal (CM) and complementary and alternative medicine (CAM) interventions. To then assess the quality of these reports by considering and comparing different types of systematic reviews and their associated RCTs; CM and CAM interventions; the effect of language restrictions compared with language inclusions, and whether these results are influenced by other issues, including statistical heterogeneity and publication bias, in the systematic review process.
    DATA SOURCES: MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews and the Centralised Information Service for Complementary Medicine.
    REVIEW METHODS: Three types of systematic reviews were included: language restricted; language inclusive/English language (EL) reviews that searched RCTs in languages other than English (LOE) but did not find any and, hence, could not include any, in the quantitative data synthesis; and systematic reviews that searched for RCTs in LOE and included them in the quantitative data synthesis. Fisher's exact test was applied to compare the three different types of systematic reviews with respect to their reporting characteristics and the systematic review quality assessment tool. The odds ratio of LOE trials versus EL trials was computed for each review and this information was pooled across the reviews to examine the influence that language of publication and type of intervention (CM, CAM) have on the estimates of intervention effect. Several sensitivity analyses were performed.
    RESULTS: The LOE RCTs were predominantly in French and German. Language inclusive/LOE systematic reviews were of the highest quality compared with the other types of reviews. The CAM reviews were of higher quality compared with the CM reviews. There were only minor differences in the quality of reports of EL RCTs compared with the eight other languages considered. However, there are inconsistent differences in the quality of LOE reports depending on the intervention type. The results, and those reported previously, suggest that excluding reports of RCTs in LOE from the analytical part of a systematic review is reasonable. Because the present research and previous efforts have not included every type of CM RCT and the resulting possibility of the uncertainty as to when bias will be present by excluding LOE, it is always prudent to perform a comprehensive search for all evidence. This result only applies to reviews investigating the benefits of CM interventions. This does not imply that systematic reviewers should neglect reports in LOE. We recommend that systematic reviewers search for reports regardless of the language. There may be merit in including them in some aspects of the review process although this decision is likely to depend on several factors, including fiscal and other resources being available. Language restrictions significantly shift the estimates of an intervention's effectiveness when the intervention is CAM. Here, excluding trials reported in LOE, compared with their inclusion, resulted in a reduced intervention effect. The present results do not appear to be influenced by statistical heterogeneity and publication bias.
    CONCLUSIONS: With the exception of CAM systematic reviews, the quality of recently published systematic reviews is less than optimal. Language inclusive/LOE systematic reviews appear to be a marker for a better quality systematic review. Language restrictions do not appear to bias the estimates of a conventional intervention's effectiveness. However, there is substantial bias in the results of a CAM systematic review if LOE reports are excluded from it.
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  • Article
    Clark W, Raftery J, Song F, Barton P, Cummins C, Fry-Smith A, Burls A.
    Health Technol Assess. 2003;7(3):1-67.
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  • Article
    Riley RD, Burchill SA, Abrams KR, Heney D, Lambert PC, Jones DR, Sutton AJ, Young B, Wailoo AJ, Lewis IJ.
    Health Technol Assess. 2003;7(5):1-162.
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  • Article
    Bagnall AM, Jones L, Ginnelly L, Lewis R, Glanville J, Gilbody S, Davies L, Torgerson D, Kleijnen J.
    Health Technol Assess. 2003;7(13):1-193.
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  • Article
    Cooper BS, Stone SP, Kibbler CC, Cookson BD, Roberts JA, Medley GF, Duckworth GJ, Lai R, Ebrahim S.
    Health Technol Assess. 2003;7(39):1-194.
    OBJECTIVE: To review the evidence for the effectiveness of different isolation policies and screening practices in reducing the incidence of methicillin-resistant Staphylococcus aureus (MRSA) colonisation and infection in hospital in-patients. To develop transmission models to study the effectiveness and cost-effectiveness of isolation policies in controlling MRSA.
    DATA SOURCES: MEDLINE, EMBASE, CINAHL, The Cochrane Library and SIGLE (1966-2000). Hand-searching key journals. No language restrictions.
    REVIEW METHODS: Key data were extracted from articles reporting MRSA-related outcomes and describing an isolation policy in a hospital with epidemic or endemic MRSA. No quality restrictions were imposed on studies using isolation wards (IW) or nurse cohorting (NC). Other studies were included if they were prospective or employed planned comparisons of retrospective data. Stochastic and deterministic models investigated long-term transmission dynamics, studying the effect of a fixed capacity IW, producing economic evaluations using local cost data.
    RESULTS: A total of 46 studies were accepted: 18 IWs, 9 NC, 19 other isolation policies. Most were interrupted time series, with few planned formal prospective studies. All but one reported multiple interventions. Consideration of potential confounders, measures to prevent bias, and appropriate statistical analysis were mostly lacking. No conclusions could be drawn in a third of studies. Most others provided evidence consistent with reduction of MRSA acquisition. Six long interrupted time series provided the strongest evidence. Four of these provided evidence that intensive control measures which included patient isolation were effective in controlling MRSA. In two others IW use failed to prevent endemic MRSA. There was no robust economic evaluation. Models showed that improving the detection rate or ensuring adequate isolation capacity reduced endemic levels, with substantial savings achievable.
    CONCLUSIONS: Major methodological weaknesses and inadequate reporting in published research mean that many plausible alternative explanations for reductions in MRSA acquisition associated with interventions cannot be excluded. No well-designed studies allow the role of isolation measures alone to be assessed. Nonetheless, there is evidence that concerted efforts that include isolation can reduce MRSA even when endemic. Little evidence was found to suggest that current isolation measures recommended in the UK are ineffective, and these should continue to be applied until further research establishes otherwise. The studies with the strongest evidence, together with the results of the modelling, provide testable hypotheses for future research. Guidelines to facilitate design of future research are produced.
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  • Article
    Mowatt G, Vale L, Perez J, Wyness L, Fraser C, MacLeod A, Daly C, Stearns SC.
    Health Technol Assess. 2003;7(2):1-174.
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  • Article
    Davenport C, Elley K, Salas C, Taylor-Weetman CL, Fry-Smith A, Bryan S, Taylor R.
    Health Technol Assess. 2003;7(7):iii-v, 1-127.
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  • Article
    Loveman E, Cave C, Green C, Royle P, Dunn N, Waugh N.
    Health Technol Assess. 2003;7(22):iii, 1-190.
    OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of educational interventions for patients with diabetes, compared with usual care or other educational interventions.
    DATA SOURCES: Electronic databases, reference lists and experts were all consulted in this study. Sponsor submissions to the National Institute of Clinical Excellence were also reviewed.
    REVIEW METHODS: Electronic databases were searched, references of all retrieved articles were checked for relevant studies, and experts were contacted for advice and peer review and to identify additional published and unpublished references. Randomised clinical trials (RCTs) and controlled clinical trials (CCTs) were included if they fulfilled pre-specified criteria, among which was follow-up from inception for 12 months or longer. Data were synthesised through a narrative review because the diversity of studies prevented a meta-analysis.
    RESULTS: Twenty-four studies (18 RCTs and six CCTs) that compared education with either a control group or with another educational intervention were included. The quality of reporting and methodology was generally found to be poor by today's standards. As part of treatment intensification, education in Type 1 diabetes (four studies) resulted in significant and long-lasting improvements in metabolic control and reductions in complications. In Type 2 diabetes (16 studies) a diversity of educational programmes did not yield consistent results on measures of metabolic control. Inconsistent results on metabolic control were also found in studies of diabetes of either type (four studies), with studies of lower quality producing significant effects. Few studies evaluated quality of life. Economic evaluations comparing education with usual care or other educational interventions were not identified.
    CONCLUSIONS: Education as part of intensification of treatment produces improvement in diabetic control in Type 1 diabetes. Mixed results in Type 2 diabetes mean that no clear characterisation is possible as to what features of education may be beneficial. Cost analysis and information from sponsor submissions indicated that where costs associated with patient education were in the region of 500-600 pounds sterling per patients, the benefits over time would have to be very modest to offer an attractive cost-effectiveness profile. Further research should focus on RCTs with clear designs based on explicit hypotheses and with a range of outcomes evaluated after long follow-up intervals.
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  • Article
    Meads C, Salas C, Roberts T, Moore D, Fry-Smith A, Hyde C.
    Health Technol Assess. 2003;7(9):v-vi, 1-98.
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  • Article
    Bagnall AM, Jones L, Richardson G, Duffy S, Riemsma R.
    Health Technol Assess. 2003;7(19):iii, 1-92.
    OBJECTIVES: To examine four key areas: (1) the effectiveness and cost-effectiveness of spinal fixation surgery, (2) the consequences of immediate versus delayed referral to a spinal injuries unit (SIU), (3) the number of people with a new spinal cord injury (SCI) who are discharged from hospital without ever being transferred to an SIU, and (4) the effectiveness and cost-effectiveness of steroids for people with SCI.
    DATA SOURCES: Searches were carried out on several databases and also on the Internet. Specialist SCI and spinal injury related websites were searched, specifically the Spinal Injuries Association, the British Association of Spinal Cord Injury Specialists and the National Spinal Cord Injury Association.
    REVIEW METHODS: Three separate search strategies were devised to find studies relating to the four key areas. Two reviewers independently screened all study citations for inclusion. The lists of all retrieved studies were scanned for additional studies. Quality of studies was assessed and data were extracted by one reviewer then checked by the second. Data from included studies were summarised within each key area. For dichotomous data, relative risks were calculated with 95% confidence intervals. Pooled relative risks were calculated as appropriate. For continuous data, mean differences with 95% confidence intervals were calculated and, if data were pooled, weighted mean differences were calculated. Searches were carried out to identify economic evaluations, details of these together with a critical appraisal of quality are presented in structured tables. Quality was assessed using a checklist supplemented with additional comments on the adequacy of methodology where appropriate.
    RESULTS: For spinal fixation versus no fixation, 68 retrospective observational studies were found that suggested some benefits of fixation surgery. Only four studies were found on fixation surgery in SIUs compared with non-SIU hospitals and no significant differences were seen. All 28 studies concerning delayed referral to a SIU were retrospective observational studies. In most, study details were poorly reported and there was doubt over the comparability of groups at baseline and on confounding factors. Times of referral and transfer were not reported separately. Evidence suggested an effect in favour of the SIU group for neurological improvement. No relevant published studies of any design were found regarding how many people with a new SCI are discharged from hospital without ever being transferred to an SIU. Two systematic reviews were found that assessed the effectiveness of steroids. No studies were identified that considered both costs and the impact on patient outcomes of a given intervention.
    CONCLUSIONS: Although there was evidence to suggest some benefits of fixation surgery and also a benefit of immediate referral to SIUs compared with delayed or no referral, owing to the limitations of the data these should be interpreted with caution. Not enough data were found to assess whether surgery is more beneficial when carried out in SIUs and further research is required in this area. Well-designed prospective observational studies with appropriately matched controls are needed. High-dose methylprednisolone steroid therapy may be effective in promoting some degree of neurological recovery if given within 8 hours of injury. There is a need for more randomised controlled trials (RCTs) of pharmacological therapy for acute SCI. No published studies of any design were found to answer the question of how many people with acute SCI are discharged from hospital without ever being transferred to an SIU. Primary research involving audit of selected hospital records should be commissioned and published. The search strategy did not identify any full economic evaluations. Future research should include full economic evaluations, possibly alongside a large RCT, which fully consider the costs and consequences of implementing interventions.
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  • Article
    Dinnes J, Loveman E, McIntyre L, Waugh N.
    Health Technol Assess. 2003;7(29):iii, 1-166.
    OBJECTIVES: To evaluate the evidence for the effectiveness and cost-effectiveness of the newer diagnostic imaging tests as an addition to clinical examination and patient history for the diagnosis of soft tissue shoulder disorders.
    DATA SOURCES: Literature was identified from several sources including general medical databases.
    REVIEW METHODS: Studies were identified that evaluated clinical examination, ultrasound, magnetic resonance imaging (MRI), or magnetic resonance arthrography (MRA) in patients suspected of having soft tissue shoulder disorders. Outcomes assessed were clinical impingement syndrome or rotator cuff tear (full, partial or any). Only cohort studies were included. The methodological quality of included test accuracy studies was assessed using a formal quality assessment tool for diagnostic studies and the extraction of study findings was conducted in duplicate using a pre-designed and piloted data extraction form to avoid any errors. For each test, sensitivity, specificity and positive and negative likelihood ratios with 95% confidence intervals were calculated for each study. Where possible pooled estimates of sensitivity, specificity and likelihood ratios were calculated using random effects methods. Potential sources of heterogeneity were investigated by conducting subgroup analyses.
    RESULTS: In the included studies, the prevalence of rotator cuff disorders was generally high, partial verification of patients was common and in many cases patients who were selected retrospectively because they had undergone the reference test. Sample sizes were generally very small. Reference tests were often inappropriate with many studies using arthrography alone, despite problems with its sensitivity. For clinical assessment, 10 cohort studies were found that examined either the accuracy of individual tests or clinical examination as a whole: individual tests were either good at ruling out rotator cuff tears when negative (high sensitivity) or at ruling in such disorders when positive (high specificity), but small sample sizes meant that there was no conclusive evidence. Ultrasound was investigated in 38 cohort studies and found to be most accurate when used for the detection of full-thickness tears; sensitivity was lower for detection of partial-thickness tears. For MRI, 29 cohort studies were included. For full-thickness tears, overall pooled sensitivities and specificities were fairly high and the studies were not statistically heterogeneous; however for the detection of partial-thickness rotator cuff tears, the pooled sensitivity estimate was much lower. The results from six MRA studies suggested that it may be very accurate for detection of full-thickness rotator cuff tears, although its performance for the detection of partial-thickness tears was less consistent. Direct evidence for the performance of one test compared with another is very limited.
    CONCLUSIONS: The results suggest that clinical examination by specialists can rule out the presence of a rotator cuff tear, and that either MRI or ultrasound could equally be used for detection of full-thickness rotator cuff tears, although ultrasound may be better at picking up partial tears. Ultrasound also may be more cost-effective in a specialist hospital setting for identification of full-thickness tears. Further research suggestions include the need for large, well-designed, prospective studies of the diagnosis of shoulder pain, in particular a follow-up study of patients with shoulder pain in primary care and a prospective cohort study of clinical examination, ultrasound and MRI, alone and/or in combination.
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  • Article
    Dalziel K, Stein K, Round A, Garside R, Royle P.
    Health Technol Assess. 2003;7(17):iii, 1-159.
    OBJECTIVES: To provide a systematic review of the clinical effectiveness of endoscopic sinus surgery (ESS) for the removal of nasal polyps.
    DATA SOURCES: Searches of electronic databases, websites and reference lists were made to identify relevant studies.
    REVIEW METHODS: An extensive search was performed to identify all articles where FESS is used for the excision of nasal polyps. Two reviewers independently screened articles for inclusion according to predefined criteria. Comparative studies were included if they were primary research, focused on FESS for the removal of nasal polyps, reported patient relevant outcomes and were published in English. In addition, case series studies were included if they met the above criteria and enrolled more than 50 patients with polyps. Data were then extracted by one reviewer and checked by a second. A structured form was used to assess the internal and external validity of included studies. Comparative data were reported where available. Excluded case series and case reports were grouped and described. A group of nine ear, nose and throat (ENT) experts were selected, then using the literature and their own experience, they generated a list of priority research questions. Existing economic evaluations were sought and described.
    RESULTS: Of the 33 studies included, the randomised controlled trials and controlled trials reported overall symptomatic improvement that ranged from 78 to 88% for FESS compared with 43 to 84% for similar techniques (including polypectomy, Caldwell-Luc and intranasal ethmoidectomy). Disease recurrence was 8% for FESS compared with 14% for Caldwell-Luc and polyp recurrence was 28% for endoscopic ethmoidectomy compared with 35% for polypectomy. Revision surgery was reported in one study only and was the same for FESS and Caldwell-Luc procedures. Percentage of overall complications was reported in only one comparative study and was 1.4% for FESS compared with 0.8% for conventional procedures. The case series studies reported overall symptomatic improvement for patients with nasal polyps ranging from 37 to 99% (median 89%). For the mixed patient groups (with and without polypoid disease) overall symptomatic improvement ranged from 40 to 98% (median 88%). Total complications in the case series studies ranged from 22.4 to 0.3% (median 6%).
    CONCLUSIONS: The majority of studies report that symptoms improve following FESS with relatively few complications; however, only a small proportion of evidence is comparative. Results from non-comparative studies do not inform the choices that need to be made by ENT surgeons and commissioners. Health economics data are also lacking and therefore cannot inform these decisions. FESS may offer some advantages in effectiveness over comparative techniques, but there is enormous variation in the range of results reported and there are severe methodological limitations. There is a clear need for quality-controlled trials in order to answer questions regarding the effectiveness of FESS. A number of priority research questions from a selection of ENT surgeons within the UK are identified and presented.
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  • Article
    Cody J, Wyness L, Wallace S, Glazener C, Kilonzo M, Stearns S, McCormack K, Vale L, Grant A.
    Health Technol Assess. 2003;7(21):iii, 1-189.
    OBJECTIVES: To evaluate the effectiveness and cost-effectiveness of tension-free vaginal tape (TVT) in comparison with the standard surgical interventions currently used.
    DATA SOURCES: Literature searches were carried out on electronic databases and websites for data covering the period 1966--2002. Other sources included references lists of relevant articles; selected experts in the field; abstracts of a limited number of conference proceedings titles; and the Internet.
    REVIEW METHODS: A systematic review of studies including comparisons of TVT with any of the comparators was conducted. Alternative treatments considered were abdominal retropubic colposuspension (including both open and laparoscopic colposuspension), traditional suburethral sling procedures and injectable agents (periurethral bulking agents). The identified studies were critically appraised and their results summarised. A Markov model comparing TVT with the comparators was developed using the results of the review of effectiveness and data on resource use and costs from previously conducted studies. The Markov model was used to estimate costs and quality-adjusted life-years for up to 10 years following surgery and it incorporated a probabilistic analysis and also sensitivity analysis around key assumptions of the model.
    RESULTS: Based on limited data from direct comparisons with TVT and from systematic reviews, laparoscopic colposuspension and traditional slings have broadly similar cure rates to TVT and open colposuspension, whereas injectable agents appear to have lower cure rates. TVT is less invasive than colposuspension and traditional sling procedures, and is also usually performed under regional or local anaesthesia. The principal operative complication is bladder perforation. There are currently no randomised controlled trial (RCT) data beyond 2 years post-surgery, and long-term effects are therefore currently not known reliably. TVT was more likely to be considered cost-effective compared with the other surgical procedures. Increasing the absolute probability of cure following TVT reduced the likelihood that TVT would be considered cost-effective.
    CONCLUSIONS: The long-term performance of TVT in terms of both continence and unanticipated adverse effects is not known reliably at the moment. Despite relatively few robust comparative data, it appears that in the short to medium term TVT's effectiveness approaches that of alternative procedures currently available, and is of lower cost. As TVT is a less invasive procedure, it is possible that some women who would currently be managed non-surgically will be considered eligible for TVT. Increased adoption of TVT will require additional surgeons proficient in the technique. It is likely that some of the higher rates of complications, e.g. bladder perforation, reported for TVT are associated with a 'learning curve'. Appropriate training will therefore be needed for surgeons new to the operation, in respect of both the technical aspects of the procedure and the choice of women suitable for the operation. Further research suggestions include unbiased assessments of longer term performance from follow-up of controlled trials or population-based registries; more data from methodologically sound RCTs using standard outcome measures; a surveillance system to detect longer term complications, if any, associated with the use of tape; and rigorous evaluation before extending the use of TVT to women who are currently managed non-surgically.
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  • Article
    Hummel S, Paisley S, Morgan A, Currie E, Brewer N.
    Health Technol Assess. 2003;7(33):iii, ix-x, 1-157.
    OBJECTIVES: To evaluate the clinical and cost-effectiveness of new and emerging technologies for early, localised prostate cancer.
    DATA SOURCES: Electronic databases, reference lists of relevant articles and various health services research-related resources.
    REVIEW METHODS: A list of new and emerging technologies was identified and agreed. A systematic review was undertaken and selected studies were reviewed against a set of criteria. An economic model was developed and used to compare the specified newer treatments with the traditional approaches.
    RESULTS: For neoadjuvant hormonal therapy, no evidence of benefit was seen in terms of biochemical disease-free survival. For adjuvant hormonal therapy, there was no evidence of benefit in terms of survival, but some conflicting evidence that higher risk patients may benefit. The largest number of studies reported results for brachytherapy, where some evidence suggested that it may be more effective than standard treatments for lower risk patients, although less effective for intermediate- and high-risk patients, in terms of biochemical disease-free survival. Lower quality evidence reported fewer complications than for standard treatments. Higher quality evidence suggested that disease-specific quality of life (QoL) for brachytherapy patients was lower than for patients receiving standard treatments. The review of three-dimensional conformal radiotherapy (3D-CRT) considered treatment-related morbidity, where significantly fewer gastrointestinal complications occurred than with standard radiotherapy. It was suggested that higher radiation doses achieved better disease control, although patient characteristics were often reported as independent indicators of control. The review of intensity-modulated conformal radiotherapy suggested that late gastrointestinal toxicity may be reduced compared with 3D-CRT. For cryotherapy, high rates of impotence were reported. Owing to the paucity and poor quality of evidence identified for other interventions, conclusions regarding their clinical effectiveness cannot be drawn. Cost-effectiveness estimates were based on the impact of adverse events on quality-adjusted life-years and the assessment was restricted to brachytherapy, 3D-CRT and cryotherapy compared with standard treatments. Of the new treatments included, only cryotherapy appeared not to be potentially cost-effective compared with traditional treatments, owing to the associated high incidence of impotence.
    CONCLUSIONS: The results of the clinical effectiveness review should be viewed in the context of the quality of the available evidence. Very few randomised controlled trials (RCTs) were identified, with the majority of included studies being descriptive case series, open to patient selection bias and measuring surrogate end-points with short-term follow-up. It is difficult therefore to draw conclusions on the relative benefits or otherwise of the newer technologies owing to the lack of substantive evidence of any quality and the lack of comparisons between the newer technologies and with standard treatments. Given the lack of high-quality clinical evidence with long-term follow-up and the uncertainty surrounding the assumptions in the economic analysis, the following areas are recommended for further research: RCTs with sufficient follow-up to measure benefits in terms of overall survival to include QoL measurement to establish trade-offs between potential adverse events and benefits of treatment; the identification of prognostic risk factors among men diagnosed with early prostate cancer; QoL studies to compare the utility of health states among patients on active monitoring, patients receiving treatment and the comparable healthy population; the relationship between surrogate end-points and survival; and the adoption of standard definitions for adverse events.
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  • Article
    Beard S, Hunn A, Wight J.
    Health Technol Assess. 2003;7(40):iii, ix-x, 1-111.
    OBJECTIVES: To identify the drug treatments currently available for the management of spasticity and pain in multiple sclerosis (MS), and to evaluate their clinical and cost-effectiveness.
    DATA SOURCES: Electronic bibliographic databases, National Research Register, MRC Clinical Trials Register and the US National Institutes of Health Clinical Trials Register.
    REVIEW METHODS: Systematic searches identified 15 interventions for the treatment of spasticity and 15 interventions for treatment of pain. The quality and outcomes of the studies were evaluated. Reviews of the treatment of spasticity and pain when due to other aetiologies were also sought.
    RESULTS: There is limited evidence of the effectiveness of four oral drugs for spasticity: baclofen, dantrolene, diazepam and tizanidine. Tizanidine appears to be no more effective than comparator drugs such as baclofen and has a slightly different side-effects profile. Despite claims that it causes less muscle weakness, there was very little evidence that tizanidine performed any better in this respect than other drugs, although it is more expensive. The findings of this review are consistent with reviews of the same treatments for spasticity derived from other aetiologies. There is good evidence that both botulinum toxin (BT) and intrathecal baclofen are effective in reducing spasticity, and both are associated with functional benefit. However, they are invasive, and substantially more expensive. None of the studies included in the review of pain were designed specifically to evaluate the alleviation of pain in patients with MS and there was no consistency regarding the use of validated outcome measures. It was suggested that, although expensive, the use of intrathecal baclofen may be associated with significant savings in hospitalisation costs in relation to bed-bound patients who are at risk of developing pressure sores, thus enhancing its cost-effectiveness. No studies of cost-effectiveness were identified in the review of pain. There is evidence, albeit limited, of the clinical effectiveness of baclofen, dantrolene, diazepam, tizanidine, intrathecal baclofen and BT and of the potential cost-effectiveness of intrathecal baclofen in the treatment of spasticity in MS.
    CONCLUSIONS: Many of the interventions identified are not licensed for the alleviation of pain or spasticity in MS and the lack of evidence relating to their effectiveness may also limit their widespread use. Indeed, forthcoming information relating to the use of cannabinoids in MS may result in there being better evidence of the effectiveness of new treatments than of any of the currently used drugs. It may therefore be of value to carry out double-blind randomised controlled trials of interventions used in current practice, where outcomes could include functional benefit and impact on quality of life. Further research into the development and validation of outcomes measures for pain and spasticity may also be useful, as perhaps would cost-utility studies.
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  • Article
    Turner D, Wailoo A, Nicholson K, Cooper N, Sutton A, Abrams K.
    Health Technol Assess. 2003;7(35):iii-iv, xi-xiii, 1-170.
    OBJECTIVES: To establish the clinical and cost-effectiveness of amantadine, oseltamivir and zanamivir compared to standard care for the treatment and prevention of influenza.
    DATA SOURCES: Electronic databases. Reference lists of identified articles and key publications. Relevant trials.
    REVIEW METHODS: A systematic review and meta-analysis of the randomised evidence was undertaken to investigate the effectiveness of oseltamivir and zanamivir compared to standard care for treatment and prophylaxis use for influenza A and B. An additional systematic review of the effectiveness of amantadine for treatment and prophylaxis use for influenza A in children and the elderly was also undertaken. Economic decision models were constructed to examine the cost-effectiveness and cost-utility of the alternative strategies for treating and preventing influenza A and/or B. This was informed by the systematic reviews outlined above and additional sources of information where required.
    RESULTS: The systematic review of the treatment of influenza found that oseltamivir reduced the median duration of symptoms in the influenza positive group by 1.38 days for the otherwise healthy adult population, 0.5 day for the high-risk population, and 1.5 days for the children population. This compared to 1.26 days, 1.99 days, and 1.3 for the similar groups for inhaled zanamivir. The systematic review of the prevention of influenza found that the relative risk reduction for oseltamivir was between approximately 75 and 90% and approximately 70 and 90% for inhaled zanamivir depending on the strategy adopted and the population under consideration. For the economic model a base case was constructed that focussed primarily on the health benefits generated by shortening the period of influenza illness. This base case found that, compared to standard care, the estimated cost per quality-adjusted life year ranged from pound 6190 to pound 31,529 for healthy adults, from pound 4535 to pound 22,502 for the 'high-risk' group, from pound 6117 to pound 30,825 for children, and from pound 5057 to pound 21,781 for the residential care elderly population. The base case model included valuations of the health effects of pneumonia (and otitis media in the children's model) based on observed rates in the trials. However it does not include the cost of hospitalisations as only very limited data was available for the effects of antivirals on hospitalisation rates. As for mortality rates, deaths from influenza were rare in trials of neuraminidase inhibitors (NIs). Therefore, suitable data on mortality were not available from these sources. As avoided hospitalisation costs and avoided mortality are potentially important we also carried out sensitivity analysis that involved extrapolating the observed reductions in pneumonias in the NI trials to hospitalisations and deaths. In all four models the cost-effectiveness of NIs is substantially improved by this extrapolation. For prophylaxis, antiviral drugs were compared with vaccination as preventative strategies. In all cases the cost-effectiveness ratios for vaccination were either low or cost-saving. In the base case the cost-effectiveness of antivirals was relatively unfavourable, there were scenarios relating to the elderly residential care model where antivirals as an additional strategy could be cost-effective.
    CONCLUSIONS: The cost-effectiveness varies markedly between the intervention strategies and target populations. The estimate of cost effectiveness is also sensitive to variations in certain key parameters of the model, for example the proportion of all influenza-like illnesses that are influenza. The effectiveness literature that was used to inform the economic decision model spans many decades and hence great caution should be exercised when interpreting the results of indirect intervention comparisons from the model. Further randomised trials making direct comparisons would be valuable to verify the model's findings.
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