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1.
Health Technol Assess ; 17(29): 1-386, 2013 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-23870108

RESUMO

BACKGROUND: Denosumab offers an alternative, or additional, treatment for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumours. OBJECTIVES: The aim of this review was to assess the clinical effectiveness and cost-effectiveness of denosumab, within its licensed indication, for the prevention of SREs in patients with bone metastases from solid tumours. DATA SOURCES: Databases searched were MEDLINE (1948 to April 2011), EMBASE (1980 to March 2011), The Cochrane Library (all sections; Issue 1, 2011) and Web of Science with Conference Proceedings (1970 to May 2011). REVIEW METHODS: Only randomised controlled trials (RCTs) assessing denosumab, bisphosphonates (BPs) or best supportive care (BSC) in patients with bone metastases were included. Systematic reviews and observational studies were used for safety and quality-of-life assessments. Study quality was assessed using the Cochrane risk of bias tool. Studies suitable for meta-analysis were synthesised using network meta-analysis (NMA). A systematic review was conducted for cost, quality-of-life and cost-effectiveness studies. The results of this informed the cost-utility modelling. This principally estimated the cost-effectiveness of denosumab relative to zoledronic acid for when BPs are currently recommended and relative to BSC when BPs are not recommended or are contraindicated. RESULTS: A literature search identified 39 studies (eight suitable for NMA). Denosumab was effective in delaying time to first SRE and reducing the risk of multiple SREs compared with zoledronic acid. Generally speaking, denosumab was similar to zoledronic acid for quality of life, pain, overall survival and safety. The NMA demonstrated that denosumab was more effective in delaying SREs than placebo, but was limited by numerous uncertainties. Cost-utility modelling results for denosumab relative to zoledronic acid were driven by the availability of the patient access scheme (PAS) for denosumab. Without this, denosumab was not estimated to be cost-effective compared with zoledronic acid. With it, the cost-effectiveness ranged between dominance for breast and prostate cancer, to between £5400 and £15,300 per quality-adjusted life-year (QALY) for other solid tumours (OSTs) including non-small cell lung cancer (NSCLC) and £12,700 per QALY for NSCLC. Owing to small patient gains estimated, the cost-effectiveness of denosumab was very sensitive to the zoledronic acid price. Denosumab was not estimated to be cost-effective compared with BSC. LIMITATIONS: Only subgroup data were available for denosumab for NSCLC, and OSTs excluding NSCLC. The NMA was subject to numerous uncertainties. Owing to small patient gains estimated, the cost-effectiveness of denosumab was very sensitive to the zoledronic acid price. CONCLUSION: Denosumab, compared with zoledronic acid and placebo, is effective in delaying SREs, but is similar with regard to quality of life and pain. Cost-effectiveness showed that without the PAS denosumab was not estimated to be cost-effective relative to either zoledronic acid or BSC. With the PAS, denosumab was estimated to be cost-effective relative to zoledronic acid but not BSC. STUDY REGISTRATION: PROSPERO number CRD42011001418. FUNDING: The National Institute for Health Research Health Technology Assessment programme.


Assuntos
Anticorpos Monoclonais Humanizados/economia , Anticorpos Monoclonais Humanizados/uso terapêutico , Neoplasias Ósseas/metabolismo , Conservadores da Densidade Óssea/economia , Conservadores da Densidade Óssea/uso terapêutico , Neoplasias da Mama/patologia , Análise Custo-Benefício , Denosumab , Feminino , Humanos , Neoplasias Pulmonares/patologia , Masculino , Modelos Econômicos , Neoplasias da Próstata/patologia , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
2.
Health Technol Assess ; 17(20): vii-xix, 1-281, 2013 May.
Artigo em Inglês | MEDLINE | ID: mdl-23697373

RESUMO

BACKGROUND: In the UK, prostate cancer (PC) is the most common cancer in men. A diagnosis can be confirmed only following a prostate biopsy. Many men find themselves with an elevated prostate-specific antigen (PSA) level and a negative biopsy. The best way to manage these men remains uncertain. OBJECTIVES: To assess the diagnostic accuracy of magnetic resonance spectroscopy (MRS) and enhanced magnetic resonance imaging (MRI) techniques [dynamic contrast-enhanced MRI (DCE-MRI), diffusion-weighted MRI (DW-MRI)] and the clinical effectiveness and cost-effectiveness of strategies involving their use in aiding the localisation of prostate abnormalities for biopsy in patients with prior negative biopsy who remain clinically suspicious for harbouring malignancy. DATA SOURCES: Databases searched--MEDLINE (1946 to March 2012), MEDLINE In-Process & Other Non-Indexed Citations (March 2012), EMBASE (1980 to March 2012), Bioscience Information Service (BIOSIS; 1995 to March 2012), Science Citation Index (SCI; 1995 to March 2012), The Cochrane Library (Issue 3 2012), Database of Abstracts of Reviews of Effects (DARE; March 2012), Medion (March 2012) and Health Technology Assessment database (March 2012). REVIEW METHODS: Types of studies: direct studies/randomised controlled trials reporting diagnostic outcomes. INDEX TESTS: MRS, DCE-MRI and DW-MRI. Comparators: T2-weighted magnetic resonance imaging (T2-MRI), transrectal ultrasound-guided biopsy (TRUS/Bx). Reference standard: histopathological assessment of biopsied tissue. A Markov model was developed to assess the cost-effectiveness of alternative MRS/MRI sequences to direct TRUS-guided biopsies compared with systematic extended-cores TRUS-guided biopsies. A health service provider perspective was adopted and the recommended 3.5% discount rate was applied to costs and outcomes. RESULTS: A total of 51 studies were included. In pooled estimates, sensitivity [95% confidence interval (CI)] was highest for MRS (92%; 95% CI 86% to 95%). Specificity was highest for TRUS (imaging test) (81%; 95% CI 77% to 85%). Lifetime costs ranged from £3895 using systematic TRUS-guided biopsies to £4056 using findings on T2-MRI or DCE-MRI to direct biopsies (60-year-old cohort, cancer prevalence 24%). The base-case incremental cost-effectiveness ratio for T2-MRI was <£30,000 per QALY (all cohorts). Probabilistic sensitivity analysis showed high uncertainty surrounding the incremental cost-effectiveness of T2-MRI in moderate prevalence cohorts. The cost-effectiveness of MRS compared with T2-MRI and TRUS was sensitive to several key parameters. LIMITATIONS: Non-English-language studies were excluded. Few studies reported DCE-MRI/DW-MRI. The modelling was hampered by limited data on the relative diagnostic accuracy of alternative strategies, the natural history of cancer detected at repeat biopsy, and the impact of diagnosis and treatment on disease progression and health-related quality of life. CONCLUSIONS: MRS had higher sensitivity and specificity than T2-MRI. Relative cost-effectiveness of alternative strategies was sensitive to key parameters/assumptions. Under certain circumstances T2-MRI may be cost-effective compared with systematic TRUS. If MRS and DW-MRI can be shown to have high sensitivity for detecting moderate/high-risk cancer, while negating patients with no cancer/low-risk disease to undergo biopsy, their use could represent a cost-effective approach to diagnosis. However, owing to the relative paucity of reliable data, further studies are required. In particular, prospective studies are required in men with suspected PC and elevated PSA levels but previously negative biopsy comparing the utility of the individual and combined components of a multiparametric magnetic resonance (MR) approach (MRS, DCE-MRI and DW-MRI) with both a MR-guided/-directed biopsy session and an extended 14-core TRUS-guided biopsy scheme against a reference standard of histopathological assessment of biopsied tissue obtained via saturation biopsy, template biopsy or prostatectomy specimens. STUDY REGISTRATION: PROSPERO number CRD42011001376. FUNDING: The National Institute for Health Research Health Technology Assessment programme.


Assuntos
Imageamento por Ressonância Magnética , Espectroscopia de Ressonância Magnética , Próstata/patologia , Neoplasias da Próstata/diagnóstico , Biópsia/métodos , Análise Custo-Benefício , Imagem de Difusão por Ressonância Magnética/economia , Imagem de Difusão por Ressonância Magnética/métodos , Humanos , Imageamento por Ressonância Magnética/economia , Imageamento por Ressonância Magnética/métodos , Espectroscopia de Ressonância Magnética/economia , Espectroscopia de Ressonância Magnética/métodos , Masculino , Neoplasias da Próstata/economia , Neoplasias da Próstata/patologia
3.
Health Technol Assess ; 16(41): 1-313, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-23127367

RESUMO

BACKGROUND: Complete surgical removal of the prostate, radical prostatectomy, is the most frequently used treatment option for men with localised prostate cancer. The use of laparoscopic (keyhole) and robot-assisted surgery has improved operative safety but the comparative effectiveness and cost-effectiveness of these options remains uncertain. OBJECTIVE: This study aimed to determine the relative clinical effectiveness and cost-effectiveness of robotic radical prostatectomy compared with laparoscopic radical prostatectomy in the treatment of localised prostate cancer within the UK NHS. DATA SOURCES: MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, BIOSIS, Science Citation Index and Cochrane Central Register of Controlled Trials were searched from January 1995 until October 2010 for primary studies. Conference abstracts from meetings of the European, American and British Urological Associations were also searched. Costs were obtained from NHS sources and the manufacturer of the robotic system. Economic model parameters and distributions not obtained in the systematic review were derived from other literature sources and an advisory expert panel. REVIEW METHODS: Evidence was considered from randomised controlled trials (RCTs) and non-randomised comparative studies of men with clinically localised prostate cancer (cT1 or cT2); outcome measures included adverse events, cancer related, functional, patient driven and descriptors of care. Two reviewers abstracted data and assessed the risk of bias of the included studies. For meta-analyses, a Bayesian indirect mixed-treatment comparison was used. Cost-effectiveness was assessed using a discrete-event simulation model. RESULTS: The searches identified 2722 potentially relevant titles and abstracts, from which 914 reports were selected for full-text eligibility screening. Of these, data were included from 19,064 patients across one RCT and 57 non-randomised comparative studies, with very few studies considered at low risk of bias. The results of this study, although associated with some uncertainty, demonstrated that the outcomes were generally better for robotic than for laparoscopic surgery for major adverse events such as blood transfusion and organ injury rates and for rate of failure to remove the cancer (positive margin) (odds ratio 0.69; 95% credible interval 0.51 to 0.96; probability outcome favours robotic prostatectomy = 0.987). The predicted probability of a positive margin was 17.6% following robotic prostatectomy compared with 23.6% for laparoscopic prostatectomy. Restriction of the meta-analysis to studies at low risk of bias did not change the direction of effect but did decrease the precision of the effect size. There was no evidence of differences in cancer-related, patient-driven or dysfunction outcomes. The results of the economic evaluation suggested that when the difference in positive margins is equivalent to the estimates in the meta-analysis of all included studies, robotic radical prostatectomy was on average associated with an incremental cost per quality-adjusted life-year that is less than threshold values typically adopted by the NHS (£30,000) and becomes further reduced when the surgical capacity is high. LIMITATIONS: The main limitations were the quantity and quality of the data available on cancer-related outcomes and dysfunction. CONCLUSIONS: This study demonstrated that robotic prostatectomy had lower perioperative morbidity and a reduced risk of a positive surgical margin compared with laparoscopic prostatectomy although there was considerable uncertainty. Robotic prostatectomy will always be more costly to the NHS because of the fixed capital and maintenance charges for the robotic system. Our modelling showed that this excess cost can be reduced if capital costs of equipment are minimised and by maintaining a high case volume for each robotic system of at least 100-150 procedures per year. This finding was primarily driven by a difference in positive margin rate. There is a need for further research to establish how positive margin rates impact on long-term outcomes. FUNDING: The National Institute for Health Research Health Technology Assessment programme.


Assuntos
Laparoscopia/economia , Modelos Econômicos , Prostatectomia/economia , Neoplasias da Próstata/cirurgia , Robótica , Análise Custo-Benefício , Humanos , Laparoscopia/métodos , Masculino , Próstata/cirurgia , Prostatectomia/métodos , Neoplasias da Próstata/economia , Robótica/economia , Robótica/métodos , Resultado do Tratamento
4.
Health Technol Assess ; 15(34): v-vi, 1-322, 2011 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-21951942

RESUMO

BACKGROUND: Following primary breast cancer treatment, the early detection of ipsilateral breast tumour recurrence (IBTR) or ipsilateral secondary cancer in the treated breast and detection of new primary cancers in the contralateral breast is beneficial for survival. Surveillance mammography is used to detect these cancers, but the optimal frequency of surveillance and the length of follow-up are unclear. OBJECTIVES: To identify feasible management strategies for surveillance and follow-up of women after treatment for primary breast cancer in a UK setting, and to determine the effectiveness and cost-effectiveness of differing regimens. METHODS: A survey of UK breast surgeons and radiologists to identify current surveillance mammography regimens and inform feasible alternatives; two discrete systematic reviews of evidence published from 1990 to mid 2009 to determine (i) the clinical effectiveness and cost-effectiveness of differing surveillance mammography regimens for patient health outcomes and (ii) the test performance of surveillance mammography in the detection of IBTR and metachronous contralateral breast cancer (MCBC); statistical analysis of individual patient data (West Midlands Cancer Intelligence Unit Breast Cancer Registry and Edinburgh data sets); and economic modelling using the systematic reviews results, existing data sets, and focused searches for specific data analysis to determine the effectiveness and cost-utility of differing surveillance regimens. RESULTS: The majority of survey respondents initiate surveillance mammography 12 months after breast-conserving surgery (BCS) (87%) or mastectomy (79%). Annual surveillance mammography was most commonly reported for women after BCS or after mastectomy (72% and 53%, respectively). Most (74%) discharge women from surveillance mammography, most frequently 10 years after surgery. The majority (82%) discharge from clinical follow-up, most frequently at 5 years. Combining initiation, frequency and duration of surveillance mammography resulted in 54 differing surveillance regimens for women after BCS and 56 for women following mastectomy. The eight studies included in the clinical effectiveness systematic review suggest surveillance mammography offers a survival benefit compared with a surveillance regimen that does not include surveillance mammography. Nine studies were included in the test performance systematic review. For routine IBTR detection, surveillance mammography sensitivity ranged from 64% to 67% and specificity ranged from 85% to 97%. For magnetic resonance imaging (MRI), sensitivity ranged from 86% to 100% and specificity was 93%. For non-routine IBTR detection, sensitivity and specificity for surveillance mammography ranged from 50% to 83% and from 57% to 75%, respectively, and for MRI from 93% to 100% and from 88% to 96%, respectively. For routine MCBC detection, one study reported sensitivity of 67% and specificity of 50% for both surveillance mammography and MRI, although this was a highly select population. Data set analysis showed that IBTR has an adverse effect on survival. Furthermore, women experiencing a second tumour measuring >20 mm in diameter were at a significantly greater risk of death than those with no recurrence or those whose tumour was <10 mm in diameter. In the base-case analysis, the strategy with the highest net benefit, and most likely to be considered cost-effective, was surveillance mammography alone, provided every 12 months at a societal willingness to pay for a quality-adjusted life-year of either £20,000 or £30,000. The incremental cost-effectiveness ratio for surveillance mammography alone every 12 months compared with no surveillance was £4727. LIMITATIONS: Few studies met the review inclusion criteria and none of the studies was a randomised controlled trial. The limited and variable nature of the data available precluded any quantitative analysis. There was no useable evidence contained in the Breast Cancer Registry database to assess the effectiveness of surveillance mammography directly. The results of the economic model should be considered exploratory and interpreted with caution given the paucity of data available to inform the economic model. CONCLUSIONS: Surveillance is likely to improve survival and patients should gain maximum benefit through optimal use of resources, with those women with a greater likelihood of developing IBTR or MCBC being offered more comprehensive and more frequent surveillance. Further evidence is required to make a robust and informed judgement on the effectiveness of surveillance mammography and follow-up. The utility of national data sets could be improved and there is a need for high-quality, direct head-to-head studies comparing the diagnostic accuracy of tests used in the surveillance population. FUNDING: The National Institute for Health Research Health Technology Assessment programme.


Assuntos
Neoplasias da Mama/diagnóstico , Análise Custo-Benefício , Mamografia/economia , Adulto , Neoplasias da Mama/economia , Neoplasias da Mama/epidemiologia , Bases de Dados Factuais , Feminino , Pesquisas sobre Atenção à Saúde , Humanos , Incidência , Imageamento por Ressonância Magnética/economia , Mamografia/métodos , Mamografia/estatística & dados numéricos , Pessoa de Meia-Idade , Recidiva Local de Neoplasia , Prevalência , Anos de Vida Ajustados por Qualidade de Vida , Sistema de Registros , Fatores de Risco , Sensibilidade e Especificidade , Análise de Sobrevida , Ultrassonografia/economia , Reino Unido/epidemiologia
5.
Health Technol Assess ; 15(25): 1-178, 2011 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-21689502

RESUMO

BACKGROUND: Imatinib dose escalation is advocated for gastrointestinal stromal tumour (GIST) treatment, but its effectiveness compared with sunitinib and best supportive care (BSC) after failure at the 400 mg/day dose is unknown. OBJECTIVES: To assess the effectiveness and cost-effectiveness of imatinib at escalated doses of 600 or 800 mg/day for patients with unresectable and/or metastatic GISTs whose disease had progressed on 400 mg/day. DATA SOURCES: Electronic databases, including MEDLlNE, MEDLINE In-Process, EMBASE, BIOSIS, Science Citation Index, Health Management Information Consortium and the Cochrane Controlled Trials Register, were searched until September 2009. REVIEW METHODS: A systematic review of the literature was carried out according to standard methods. An economic model was constructed to assess the cost-effectiveness of seven alternative pathways for treating patients with unresectable and/or metastatic GISTs. RESULTS: Five primary studies involving 669 people were included for clinical effectiveness; four reported imatinib and one reported sunitinib. The data were essentially observational as none of the studies was designed to specifically assess treatment of patients whose disease had progressed on 400 mg/day imatinib. For 600 mg/day imatinib, between 26% and 42% of patients showed either a partial response (PR) or stable disease (SD). Median time to progression was 1.7 months (range 0.7-24.9 months). For 800 mg/day imatinib, between 29% and 33% of patients showed either a PR or SD. Median overall survival (OS) was 19 months [95% confidence interval (CI) 13 to 23 months]. Progression-free survival ranged from 81 days to 5 months (95% CI 2 to 10 months). Median duration of response was 153 days (range 37-574 days). Treatment progression led to 88% discontinuations but between 16% and 31% of patients required a dose reduction, and 23% required a dose delay. There was a statistically significant increase in the severity of fatigue (p < 0.001) and anaemia (p = 0.015) following dose escalation. For sunitinib, median OS was 90 weeks (95% CI 73 to 106 weeks). For the cost-effectiveness review, only one full-text study and one abstract were identified, comparing imatinib at an escalated dose, sunitinib and BSC, although neither was based on a UK context. The definition of BSC was not consistent across the studies, and the pattern of resources (including drugs for treatment) and measures of effectiveness also varied. Within the model, BSC (assumed to include continuing medication to prevent tumour flare) was the least costly and least effective. It would be the care pathway most likely to be cost-effective when the cost per quality-adjusted life-year threshold was < £25,000. Imatinib at 600 mg/day was most likely to be cost-effective at a threshold between £25,000 and £45,000. Imatinib at 600 mg/day followed by further escalation followed by sunitinib was most likely to be cost-effective at a threshold > £45,000. LIMITATIONS: The evidence base was sparse, data were non-randomised and potentially biased. The economic model results are surrounded by a considerable degree of uncertainty and open to biases of unknown magnitude and direction. CONCLUSIONS: Around one-third of patients with unresectable and/or metastatic GIST, who fail on 400 mg/day of imatinib, may show response or SD with escalated doses. Between a threshold of £25,000 and £45,000, provision of an escalated dose of imatinib would be most likely to be cost-effective. However, these results should be interpreted with caution owing to the limited evidence available on outcomes following imatinib dose escalation or sunitinib for this group of patients. FUNDING: The National Institute for Health Research Health Technology Assessment programme.


Assuntos
Antineoplásicos/economia , Tumores do Estroma Gastrointestinal/tratamento farmacológico , Piperazinas/economia , Pirimidinas/economia , Antineoplásicos/administração & dosagem , Antineoplásicos/uso terapêutico , Benzamidas , Intervalos de Confiança , Análise Custo-Benefício , Progressão da Doença , Tumores do Estroma Gastrointestinal/economia , Tumores do Estroma Gastrointestinal/patologia , Humanos , Mesilato de Imatinib , Incidência , Modelos Econômicos , Piperazinas/administração & dosagem , Piperazinas/uso terapêutico , Pirimidinas/administração & dosagem , Pirimidinas/uso terapêutico , Anos de Vida Ajustados por Qualidade de Vida , Análise de Sobrevida , Fatores de Tempo , Resultado do Tratamento , Incerteza , Estados Unidos
6.
Health Technol Assess ; 15 Suppl 1: 23-32, 2011 May.
Artigo em Inglês | MEDLINE | ID: mdl-21609650

RESUMO

This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of eltrombopag for the treatment of adults with chronic idiopathic (immune) thrombocytopenic purpura (ITP), based on a review of the manufacturer's submission (MS) to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal process. ITP is an autoimmune disorder by which antibodies are formed against platelets with annual incidence rates in the UK/USA ranging from 1.13 to 6.62 cases per 100,000 adults. Eltrombopag increases the production of platelets at a rate that outpaces their destruction by the immune system, and has a UK marketing authorisation both for the treatment of adult ITP in splenectomised patients who are refractory to other treatments and as a second-line treatment for adult non-splenectomised patients for whom surgery is contraindicated. Both splenectomised and non-splenectomised patient groups were considered in the analysis. Two economic models were presented, one for a watch-and-rescue treatment scenario and the second for the long-term treatment of patients with more severe ITP. The submission's evidence was sourced from the relatively high-quality RAISE [RAndomized placebo-controlled Idiopathic thrombocytopenic purpura (ITP) Study with Eltrombopag] randomised controlled trial. The study indicated a statistically significant difference in favour of eltrombopag compared with placebo in the odds of achieving the primary outcome of a platelet count of between 50 and 400 × 109/l during the 6-month treatment period (odds ratio 8.2, 99% confidence interval 3.6 to 18.7). In the eltrombopag group, 50/83 (60%) non-splenectomised patients and 18/49 (37%) splenectomised patients achieved this outcome. Median duration of response for all patients was 10.9 weeks (splenectomised patients 6 weeks and non-splenectomised patients 13.4 weeks). Patients treated with eltrombopag required less rescue medication and had lower odds of bleeding events than placebo-treated subjects in both patient groups. In the watch-and-rescue economic model, the ERG found that substantial reductions in the cost of eltrombopag are needed for the incremental cost-effectiveness ratio (ICER) to fall below £ 30,000. Further analyses found that the ICER varied from £33,561 to £ 103,500 per quality-adjusted life-year (QALY) (splenectomised) and from £ 39,657 to £ 150,245 per QALY (non-splenectomised). Other than bleeding, no adverse events were modelled. In relation to the long-term treatment model, the ERG found that using non-randomised non-comparative data may result in biased estimates of unknown magnitude and direction. None of the treatment sequences resulted in an ICER approaching the recommended threshold of £ 30,000. The base-case results, using a 2-year time horizon and prescribing eltrombopag as second-line treatment post rituximab, were found to be favourable towards eltrombopag. In conclusion, based on the MS and additional ERG work, eltrombopag appears to be a safe treatment for ITP (although long-term follow-up studies are awaited) and has short-term efficacy. However, there is no robust evidence on long-term efficacy or cost-effectiveness of eltrombopag, and there is a lack of robust direct evidence on the effectiveness and cost-effectiveness of eltrombopag compared with other relevant comparators. NICE did not recommend eltrombopag for the treatment of chronic ITP within its marketing authorisation for splenectomised or non-splenectomised patients.


Assuntos
Benzoatos/uso terapêutico , Hidrazinas/uso terapêutico , Pirazóis/uso terapêutico , Receptores de Trombopoetina/agonistas , Trombocitemia Essencial/tratamento farmacológico , Benzoatos/administração & dosagem , Benzoatos/economia , Doença Crônica , Análise Custo-Benefício , Humanos , Hidrazinas/administração & dosagem , Hidrazinas/economia , Metanálise como Assunto , Modelos Econômicos , Contagem de Plaquetas , Pirazóis/administração & dosagem , Pirazóis/economia , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Receptores Fc/uso terapêutico , Proteínas Recombinantes de Fusão/uso terapêutico , Esplenectomia , Trombopoetina/uso terapêutico
7.
Health Technol Assess ; 14(4): 1-331, iii-iv, 2010 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-20082749

RESUMO

OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of photodynamic diagnosis (PDD) compared with white light cystoscopy (WLC), and urine biomarkers [fluorescence in situ hybridisation (FISH), ImmunoCyt, NMP22] and cytology for the detection and follow-up of bladder cancer. DATA SOURCES: Major electronic databases including MEDLINE, MEDLINE In-Process, EMBASE, BIOSIS, Science Citation Index, Health Management Information Consortium and the Cochrane Controlled Trials Register were searched until April 2008. REVIEW METHODS: A systematic review of the literature was carried out according to standard methods. An economic model was constructed to assess the cost-effectiveness of alternative diagnostic and follow-up strategies for the diagnosis and management of patients with bladder cancer. RESULTS: In total, 27 studies reported PDD test performance. In pooled estimates [95% confidence interval (CI)] for patient-level analysis, PDD had higher sensitivity than WLC [92% (80% to 100%) versus 71% (49% to 93%)] but lower specificity [57% (36% to 79%) versus 72% (47% to 96%)]. Similar results were found for biopsy-level analysis. The median sensitivities (range) of PDD and WLC for detecting lower risk, less aggressive tumours were similar for patient-level detection [92% (20% to 95%) versus 95% (8% to 100%)], but sensitivity was higher for PDD than for WLC for biopsy-level detection [96% (88% to 100%) versus 88% (74% to 100%)]. For more aggressive, higher-risk tumours the median sensitivity of PDD for both patient-level [89% (6% to 100%)] and biopsy-level [99% (54% to 100%)] detection was higher than those of WLC [56% (0% to 100%) and 67% (0% to 100%) respectively]. Four RCTs comparing PDD with WLC reported effectiveness outcomes. PDD use at transurethral resection of bladder tumour resulted in fewer residual tumours at check cystoscopy [relative risk, RR, 0.37 (95% CI 0.20 to 0.69)] and longer recurrence-free survival [RR 1.37 (95% CI 1.18 to 1.59)] compared with WLC. In 71 studies reporting the performance of biomarkers and cytology in detecting bladder cancer, sensitivity (95% CI) was highest for ImmunoCyt [84% (77% to 91%)] and lowest for cytology [44% (38% to 51%)], whereas specificity was highest for cytology [96% (94% to 98%)] and lowest for ImmunoCyt [75% (68% to 83%)]. In the cost-effectiveness analysis the most effective strategy in terms of true positive cases (44) and life-years (11.66) [flexible cystoscopy (CSC) and ImmunoCyt followed by PDD in initial diagnosis and CSC followed by WLC in follow-up] had an incremental cost per life-year of over 270,000 pounds. The least effective strategy [cytology followed by WLC in initial diagnosis (average cost over 20 years 1403 pounds, average life expectancy 11.59)] was most likely to be considered cost-effective when society's willingness to pay was less than 20,000 pounds per life-year. No strategy was cost-effective more than 50% of the time, but four of the eight strategies in the probabilistic sensitivity analysis (three involving a biomarker or PDD) were each associated with a 20% chance of being considered cost-effective. In sensitivity analyses the results were most sensitive to the pretest probability of disease (5% in the base case). CONCLUSIONS: The advantages of PDD's higher sensitivity in detecting bladder cancer have to be weighed against the disadvantages of a higher false-positive rate. Taking into account the assumptions made in the model, strategies involving biomarkers and/or PDD provide additional benefits at a cost that society might be willing to pay. Strategies replacing WLC with PDD provide more life-years but it is unclear whether they are worth the extra cost.


Assuntos
Neoplasias da Bexiga Urinária/diagnóstico , Neoplasias da Bexiga Urinária/urina , Bexiga Urinária/citologia , Biomarcadores Tumorais/economia , Análise Custo-Benefício , Cistoscopia/economia , Cistoscopia/normas , Técnicas de Apoio para a Decisão , Técnicas de Diagnóstico Urológico/economia , Técnicas de Diagnóstico Urológico/normas , Humanos , Hibridização in Situ Fluorescente/economia , Hibridização in Situ Fluorescente/normas , Incidência , Modelos Econômicos , Proteínas Nucleares/economia , Fármacos Fotossensibilizantes/economia , Prevalência , Sensibilidade e Especificidade , Resultado do Tratamento , Reino Unido/epidemiologia , Bexiga Urinária/patologia , Bexiga Urinária/cirurgia , Neoplasias da Bexiga Urinária/epidemiologia , Neoplasias da Bexiga Urinária/terapia
8.
Health Technol Assess ; 13 Suppl 2: 63-8, 2009 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-19804691

RESUMO

This paper presents a summary of the evidence review group (ERG) report into the clinical and cost-effectiveness of romiplostim for the treatment of adults with chronic immune or idiopathic thrombocytopenic purpura (ITP) based upon a review of the manufacturer's submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The submission's evidence came from two relatively high-quality randomised controlled trials (RCTs). The ERG found no evidence that any important data were missed or that data extraction was inaccurate. In both RCTs more patients in the romiplostim than in the placebo group achieved a durable platelet response [non-splenectomised patients: romiplostim 25/41 (61%), placebo 1/21 (5%), odds ratio (OR) 24.45, 95% confidence interval (CI) 3.34 to 179.18; splenectomised patients: romiplostim 16/42 (38%), placebo 0/21 (0%), OR 8.5 (95% CI 1.15 to 372)] and an overall platelet response [non-splenectomised patients: romiplostim 36/41 (88%), placebo 3/21 (14%), OR 34.74, 95% CI 7.77 to 155.38; splenectomised patients: romiplostim 33/42 (79%), placebo 0/21 (0%), OR 16.6 (95% CI 2.37 to 706]. The difference in mean period with a platelet response was 13.9 weeks (95% CI 10.5 to 17.4) in favour of romiplostim in the RCT of non-splectomised patients and 12.1 weeks (95% CI 8.7 to 15.6) in favour of romiplostim in the RCT of splectomised patients. The manufacturer's economic model evaluated the cost-effectiveness of romiplostim compared with standard care. The ERG had concerns about the way the decision problem was addressed in the economic model and about the non-adjustment of findings for confounding factors. In non-splenectomised patients, using romiplostim as a first option treatment, the base-case incremental cost-effectiveness ratio (ICER) was 14,840 pounds per quality-adjusted life-year (QALY). In splenectomised patients the ICER was 14,655 pounds per QALY. Additional sensitivity analyses performed by the ERG identified two issues of importance: whether individuals entered the model on watch and rescue or on active therapy in the comparator arm (ICER 21,674 pounds per QALY for non-splenectomised patients, 29,771 pounds per QALY for splenectomised patients); whether it was assumed that any unused medicine would be wasted. Combining all of the separate sensitivity analyses, and assuming that watch and rescue was not the first-line treatment, increased the ICERs further (non-splenectomised 37,290 pounds per QALY; splenectomised 131,017 pounds per QALY). In conclusion, the manufacturer's submission and additional work conducted by the ERG suggest that romiplostim has short-term efficacy for the treatment of ITP, but there is no robust evidence on long-term effectiveness or cost-effectiveness of romiplostim compared with relevant comparators.


Assuntos
Imunossupressores/economia , Imunossupressores/uso terapêutico , Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Receptores Fc/uso terapêutico , Proteínas Recombinantes de Fusão/economia , Proteínas Recombinantes de Fusão/uso terapêutico , Trombopoetina/economia , Trombopoetina/uso terapêutico , Pesquisa Comparativa da Efetividade , Análise Custo-Benefício , Humanos , Púrpura Trombocitopênica Idiopática/imunologia , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Esplenectomia
9.
Health Technol Assess ; 13(7): iii-iv, ix-xii, 1-95, 2009 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-19200414

RESUMO

OBJECTIVES: To assess the effectiveness and cost-effectiveness of oesophageal Doppler monitoring (ODM) compared with conventional clinical assessment and other methods of monitoring cardiovascular function. DATA SOURCES: Electronic databases and relevant websites from 1990 to May 2007 were searched. REVIEW METHODS: This review was based on a systematic review conducted by the US Agency for Healthcare Research and Quality (AHRQ), supplemented by evidence from any additional studies identified. Comparator interventions for effectiveness were standard care, pulmonary artery catheters (PACs), pulse contour analysis monitoring and lithium or thermodilution cardiac monitoring. Data were extracted on mortality, length of stay overall and in critical care, complications and quality of life. The economic assessment evaluated strategies involving ODM compared with standard care, PACs, pulse contour analysis monitoring and lithium or thermodilution cardiac monitoring. RESULTS: The AHRQ report contained eight RCTs and was judged to be of high quality overall. Four comparisons were reported: ODM plus central venous pressure (CVP) monitoring plus conventional assessment vs CVP monitoring plus conventional assessment during surgery; ODM plus conventional assessment vs CVP monitoring plus conventional assessment during surgery; ODM plus conventional assessment vs conventional assessment during surgery; and ODM plus CVP monitoring plus conventional assessment vs CVP monitoring plus conventional assessment postoperatively. Five studies compared ODM plus CVP monitoring plus conventional assessment with CVP monitoring plus conventional assessment during surgery. There were fewer deaths [Peto odds ratio (OR) 0.13, 95% CI 0.02-0.96], fewer major complications (Peto OR 0.12, 95% CI 0.04-0.31), fewer total complications (fixed-effects OR 0.43, 95% CI 0.26-0.71) and shorter length of stay (pooled estimate not presented, 95% CI -2.21 to -0.57) in the ODM group. The results of the meta-analysis of mortality should be treated with caution owing to the low number of events and low overall number of patients in the combined totals. Three studies compared ODM plus conventional assessment with conventional assessment during surgery. There was no evidence of a difference in mortality (fixed-effects OR 0.81, 95% CI 0.23-2.77). Length of hospital stay was shorter in all three studies in the ODM group. Two studies compared ODM plus CVP monitoring plus conventional assessment vs CVP monitoring plus conventional assessment in critically ill patients. The patient groups were quite different (cardiac surgery and major trauma) and neither study, nor a meta-analysis, showed a statistically significant difference in mortality (fixed-effects OR 0.84, 95% CI 0.41-1.70). Fewer patients in the ODM group experienced complications (OR 0.49, 95% CI 0.30-0.81) and both studies reported a statistically significant shorter median length of hospital stay in that group. No economic evaluations that met the inclusion criteria were identified from the existing literature so a series of balance sheets was constructed. The results show that ODM strategies are likely to be cost-effective. CONCLUSIONS: More formal economic evaluation would allow better use of the available data. All identified studies were conducted in unconscious patients. However, further research is needed to evaluate new ODM probes that may be tolerated by awake patients. Given the paucity of the existing economic evidence base, any further primary research should include an economic evaluation or should provide data suitable for use in an economic model.


Assuntos
Velocidade do Fluxo Sanguíneo/fisiologia , Débito Cardíaco/fisiologia , Ecocardiografia Doppler/métodos , Ecocardiografia Transesofagiana/métodos , Monitorização Fisiológica/métodos , Aorta/fisiologia , Análise Custo-Benefício , Estado Terminal , Ecocardiografia Doppler/economia , Ecocardiografia Transesofagiana/economia , Humanos , Monitorização Intraoperatória , Monitorização Fisiológica/economia , Avaliação de Resultados em Cuidados de Saúde , Procedimentos Cirúrgicos Operatórios , Avaliação da Tecnologia Biomédica
10.
Health Technol Assess ; 12(35): iii, ix-x, 1-146, 169-515, 2008 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-19032882

RESUMO

OBJECTIVES: To determine the clinical effectiveness and cost utility of procedures alternative to TURP (transurethral resection of the prostate) for benign prostatic enlargement (BPE) unresponsive to expectant, non-surgical treatments. DATA SOURCES: Electronic searches of 13 databases to identify relevant randomised controlled trials (RCTs). REVIEW METHODS: Two reviewers independently assessed study quality and extracted data. The International Prostate Symptom Score/American Urological Association (IPSS/AUA) symptom score was the primary outcome; others included quality of life, peak urine flow rate and adverse effects. Cost-effectiveness was assessed using a Markov model reflecting likely care pathways. RESULTS: 156 reports describing 88 RCTs were included. Most had fewer than 100 participants (range 12-234). TURP provided consistent, high-level, long-term symptomatic improvement. Minimally invasive procedures resulted in less marked improvement. Ablative procedures gave improvements equivalent to TURP. Holmium laser enucleation of the prostate (HoLEP) additionally resulted in greater improvement in flow rate. HoLEP is unique amongst the newer technologies in offering an advantage in urodynamic outcomes over TURP, although long-term follow-up data are lacking. Severe blood loss was more common following TURP. Rates of incontinence were similar across all interventions other than transurethral needle ablation (TUNA) and laser coagulation, for which lower rates were reported. Acute retention and reoperation were commoner with newer technologies, especially minimally invasive interventions. The economic model suggested that minimally invasive procedures were unlikely to be cost-effective compared with TURP. Transurethral vaporisation of the prostate (TUVP) was both less costly and less effective than TURP. HoLEP was estimated to be more cost-effective than a single TURP but less effective than a strategy involving repeat TURP if necessary. The base-case analysis suggested an 80% chance that TUVP, followed by HoLEP if required, would be cost-effective at a threshold of 20,000 pounds per quality-adjusted life-year. At a 50,000 pounds threshold, TUVP, followed by TURP as required, would be cost-effective, although considerable uncertainty surrounds this finding. The main limitations are the quantity and quality of the data available, in the context of multiple comparisons. CONCLUSIONS: In the absence of strong evidence in favour of newer methods, the standard--TURP--remains both clinically effective and cost-effective. There is a need for further research to establish (i) how many years of medical treatment are necessary to offset the cost of treatment with a minimally invasive or ablative intervention; (ii) more cost-effective alternatives to TURP; and (iii) strategies to improve outcomes after TURP.


Assuntos
Hipertermia Induzida , Terapia a Laser , Hiperplasia Prostática/cirurgia , Ressecção Transuretral da Próstata , Resultado do Tratamento , Idoso , Análise Custo-Benefício , Bases de Dados Bibliográficas , Humanos , Hipertermia Induzida/economia , Hipertermia Induzida/métodos , Terapia a Laser/economia , Lasers de Estado Sólido/uso terapêutico , Masculino , Procedimentos Cirúrgicos Minimamente Invasivos/economia , Hiperplasia Prostática/diagnóstico por imagem , Hiperplasia Prostática/fisiopatologia , Avaliação da Tecnologia Biomédica/economia , Ressecção Transuretral da Próstata/economia , Ultrassonografia
11.
Heart ; 94(11): 1386-93, 2008 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-18669550

RESUMO

CONTEXT: Coronary artery disease (CAD) is a major cause of mortality and ill health. OBJECTIVE: To assess whether 64-slice CT angiography might replace some coronary angiography (CA) for diagnosis and assessment of CAD. DATA SOURCES: Electronic databases, conference proceedings and reference lists of included studies. STUDY SELECTION: Eligible studies compared 64-slice CT with a reference standard of CA in adults with suspected/known CAD, reporting sensitivity and specificity or true and false positives and negatives. DATA EXTRACTION: Two reviewers independently extracted data from included studies. RESULTS: Forty studies were included; 28 provided sufficient data for inclusion in the meta-analyses, all using a cut off point of >/=50% stenosis to define significant CAD. In patient-based detection (n = 1286) 64-slice CT pooled sensitivity was 99% (95% credible interval (CrI) 97% to 99%), specificity 89% (95% CrI 83% to 94%), median positive predictive value (PPV) across studies 93% (range 64-100%) and negative predictive value (NPV) 100% (range 86-100%). In segment-based detection (n = 14 199) 64-slice CT pooled sensitivity was 90% (95% CrI 85% to 94%), specificity 97% (95% CrI 95% to 98%), median PPV across studies 76% (range 44-93%) and NPV 99% (range 95-100%). CONCLUSIONS: 64-Slice CT is highly sensitive for patient-based detection of CAD and has high NPV. An ability to rule out significant CAD means that it may have a role in the assessment of chest pain, particularly when the diagnosis remains uncertain despite clinical evaluation and simple non-invasive testing.


Assuntos
Calcinose/diagnóstico por imagem , Dor no Peito/diagnóstico por imagem , Angiografia Coronária/instrumentação , Doença da Artéria Coronariana/diagnóstico por imagem , Tomografia Computadorizada por Raios X/métodos , Idoso , Dor no Peito/etiologia , Angiografia Coronária/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intensificação de Imagem Radiográfica , Sensibilidade e Especificidade
12.
BJOG ; 115(11): 1350-61, 2008 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-18715243

RESUMO

BACKGROUND: The efficacy and safety of mesh/graft in surgery for anterior or posterior pelvic organ prolapse is uncertain. OBJECTIVES: To systematically review the efficacy and safety of mesh/graft for anterior or posterior vaginal wall prolapse surgery. SEARCH STRATEGY: Electronic databases and conference proceedings were searched, experts and manufacturers contacted, and reference lists of retrieved papers scanned. SELECTION CRITERIA: Randomised controlled trials (RCTs), nonrandomised comparative studies, registries, case series involving at least 50 women, and RCTs published as conference abstracts from 2005 onwards. DATA COLLECTION AND ANALYSIS: One reviewer screened titles/abstracts, undertook data extraction, and assessed study quality. Data analysis was conducted for three subgroups: anterior, posterior, and anterior and/or posterior repair (not reported separately). RESULTS: Forty-nine studies involving 4569 women treated with mesh/graft were included. Study quality was generally high. Median follow up was 13 months (range 1-51 months). In anterior repair, there was short-term evidence that mesh/graft (any type) significantly reduced objective prolapse recurrence rates compared with no mesh/graft (relative risk 0.48, 95% CI 0.32-0.72). Nonabsorbable synthetic mesh had a significantly lower objective prolapse recurrence rate (8.8%, 48/548) than absorbable synthetic mesh (23.1%, 63/273) and biological graft (17.9%, 186/1041), but a higher erosion rate (10.2%, 68/666) than absorbable synthetic mesh (0.7%, 1/147) and biological graft (6.0%, 35/581). There was insufficient information to compare any of the other outcomes regardless of prolapse type. CONCLUSIONS: Evidence for most outcomes was too sparse to provide meaningful conclusions. Rigorous long-term RCTs are required to determine the comparative efficacy of using mesh/graft.


Assuntos
Retalhos Cirúrgicos/normas , Telas Cirúrgicas/normas , Prolapso Uterino/cirurgia , Adulto , Idoso , Falha de Equipamento , Feminino , Humanos , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Retalhos Cirúrgicos/efeitos adversos , Telas Cirúrgicas/efeitos adversos , Resultado do Tratamento
13.
Br J Surg ; 94(8): 925-36, 2007 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-17636511

RESUMO

BACKGROUND AND METHOD: Foam sclerotherapy is a potential treatment for varicose veins. A systematic review was undertaken to assess its safety and efficacy. RESULTS: Sixty-nine studies were included. The median rates of serious adverse events, including pulmonary embolism and deep vein thrombosis, were less than 1 per cent. The median rate of visual disturbance was 1.4 per cent, headache 4.2 per cent, thrombophlebitis 4.7 per cent, matting/skin staining/pigmentation 17.8 per cent and pain at the site of injection 25.6 per cent. The median rate of complete occlusion of treated veins was 87.0 per cent and for recurrence or development of new veins it was 8.1 per cent. Meta-analysis for complete occlusion suggests that foam sclerotherapy is less effective than surgery (relative risk (RR) 0.86 (95 per cent confidence interval (c.i.) 0.67 to 1.10)) but more effective than liquid sclerotherapy (RR 1.39 (95 per cent c.i. 0.91 to 2.11)), although there was substantial heterogeneity between studies. CONCLUSION: Serious adverse events associated with foam sclerotherapy are rare. There is insufficient evidence to allow a meaningful comparison of the effectiveness of this treatment with that of other minimally invasive therapies or surgery.


Assuntos
Escleroterapia/métodos , Varizes/terapia , Humanos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Escleroterapia/efeitos adversos , Resultado do Tratamento
14.
Clin Otolaryngol ; 31(2): 95-102, 2006 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-16620327

RESUMO

In the meta-analysis models, compared with cold steel dissection with ties/packs haemostasis (reference technique): * Bipolar diathermy dissection and haemostasis was associated with statistically significant lower odds of primary haemorrhage (OR 0.13, 95% CrI 0.03 to 0.51), including primary haemorrhage requiring return to theatre (OR 0.002, 95% CrI <0.001 to 0.26). * Coblation was associated with statistically significant higher odds of secondary haemorrhage requiring return to theatre (OR 33.82, 95% CrI 1.25 to 5676.00). * Monopolar and bipolar diathermy dissection and haemostasis (OR 4.12, 95% CrI 1.12 to 14.67; OR 2.86, 95% CrI 1.12 to 8.02, respectively), coblation (OR 3.75, 95% CrI 1.29 to 12.12), and cold steel dissection with monopolar or bipolar diathermy haemostasis (OR 4.83, 95% CrI 1.56 to 15.95; OR 9.18, 95% CrI 3.09 to 30.53, respectively) were all associated with statistically significant higher odds of secondary haemorrhage. * In deciding which technique to employ, factors to consider include patient characteristics, the underlying risk of primary or secondary haemorrhage, which is regarded as likely to be more serious, and the clinical significance of the observed differences in haemorrhage rates across techniques.


Assuntos
Eletrocirurgia/normas , Hemorragia Pós-Operatória/etiologia , Tonsilectomia/métodos , Eletrocoagulação/normas , Eletrocirurgia/efeitos adversos , Hemostasia Cirúrgica/métodos , Humanos , Reoperação , Fatores de Risco , Fatores de Tempo , Tonsilectomia/efeitos adversos
15.
Br J Surg ; 91(12): 1559-69, 2004 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-15455360

RESUMO

BACKGROUND AND METHOD: This systematic review assesses the efficacy and safety of sacral nerve stimulation (SNS) for faecal incontinence and constipation. Electronic databases and selected websites were searched for studies evaluating SNS in the treatment of faecal incontinence or constipation. Primary outcome measures included episodes of faecal incontinence per week (faecal incontinence studies) and number of evacuations per week (constipation studies). RESULTS: From 106 potentially relevant reports, six patient series and one crossover study of SNS for faecal incontinence, and four patient series and one crossover study of SNS for constipation, were included. After implantation, 41-75 per cent of patients achieved complete faecal continence and 75-100 per cent experienced improvement in episodes of incontinence. There were 19 adverse events among 149 patients. The small crossover study reported increased episodes of faecal incontinence when the implanted pulse generator was switched off. Case series of SNS for constipation reported an increased frequency of evacuation. There were four adverse events among the 20 patients with a permanent implant. The small crossover study reported a reduced number of evacuations when the pulse generator was switched off. CONCLUSION: SNS results in significant improvement in faecal incontinence in patients resistant to conservative treatment. Early data also suggest benefit in the treatment of constipation.


Assuntos
Constipação Intestinal/terapia , Terapia por Estimulação Elétrica/métodos , Incontinência Fecal/terapia , Estudos Cross-Over , Terapia por Estimulação Elétrica/efeitos adversos , Humanos , Plexo Lombossacral , Manometria , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
16.
Health Technol Assess ; 1(14): i-vi, 1-149, 1997.
Artigo em Inglês | MEDLINE | ID: mdl-9483162

RESUMO

OBJECTIVES. To try to identify the optimal time at which to start assessing new and fast-evolving health technologies. To provide insight into factors influencing the timing of assessments and the choice of methods for assessing new and fast-changing technologies. HOW THE RESEARCH WAS CONDUCTED. A series of literature reviews were undertaken covering the general principles involved in the timing of health technology assessments (HTAs). Additionally, the reported assessments of laparoscopic cholecystectomy, chorionic villus sampling (CVS), teleradiology, teledermatology, genetic screening for predisposition to breast cancer, and gene therapy for cystic fibrosis were reviewed to try to identify the factors that influenced the timing of these assessments. Key individuals in each field were also interviewed. The selected technologies allowed comparison between those that were new and evolving and those that were relatively well-established. A bibliometric study of publication trends was also undertaken to see whether these trends would suggest points in the development of a technology that could be used as indicators that assessment should be started. RESEARCH FINDINGS. TIMING. The precise point at which assessment should start was not identified but the bibliometric study suggested that extending this approach might give useful results. For all health technologies, more regular reporting of outcomes and side-effects should be encouraged during the period after initial assessment and, where the technology is fast-changing, reassessment should take place from time to time. The precise intervals were not identified and the problem remains of deciding when a technology has changed enough to warrant reassessment. FACTORS INFLUENCING TIMING. Published reports of assessments did not generally specify the reasons for their timing, but a number of factors appear to have influenced the timing of those assessments, directly or indirectly. Product champions and opinion leaders pioneer the introduction of new technologies into clinical practice, and their reports may lead to the rapid diffusion of such technologies before they have been adequately evaluated, as was the case with laparoscopic cholecystectomy; this diffusion may limit the methods of evaluation that can then be used. It is therefore important to assess new health technologies before diffusion takes place. The extent to which regulatory control is imposed on the introduction of new health technologies can also influence the timing of assessments. Such controls might have helped to restrict the diffusion of laparoscopic cholecystectomy, making a large and widely generalisable randomised controlled trial (RCT) feasible. The source and availability of funding for studies may influence the nature and timing of trials. Many telemedicine evaluations were funded by commercial telecommunications organisations and were thus restricted in their timing (and biased towards the technological aspects of the applications) by the availability of funds. Media coverage undoubtedly has an influence although this influence is not always predictable; it may generate 'favourable' publicity about new health technologies, which can lead to immediate demands for the new technique, as was the case with laparosocpic cholecystectomy with its apparent benefits. Thus assessments should be made before media coverage exerts popular pressure on purchasers to adopt the technology and dissuades patients from participating in RCTs (because of fear they may be randomised to the standard treatment as occurred in a US trial of CVS). Innovators should also be cautious in the claims that they make to the media.(ABSTRACT TRUNCATED)


Assuntos
Ciência de Laboratório Médico , Avaliação da Tecnologia Biomédica , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/genética , Colecistectomia Laparoscópica/métodos , Colecistectomia Laparoscópica/normas , Amostra da Vilosidade Coriônica/métodos , Amostra da Vilosidade Coriônica/normas , Ensaios Clínicos como Assunto , Fibrose Cística/diagnóstico , Fibrose Cística/genética , Difusão de Inovações , Feminino , Testes Genéticos/métodos , Testes Genéticos/normas , Humanos , Ciência de Laboratório Médico/normas , Ciência de Laboratório Médico/tendências , Gravidez , Avaliação da Tecnologia Biomédica/normas , Avaliação da Tecnologia Biomédica/tendências , Telemedicina/métodos , Telemedicina/normas , Reino Unido
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