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Biomedical subjects

P Royle

Publications and source records attributed to P Royle.

At least 19 recordsLinked to original sources
PubMed2005

Surgery for morbid obesity.

BACKGROUND: Obesity is associated with increased morbidity and mortality. Surgery for morbid obesity is considered when other treatments have failed. A number of procedures are available, but the effects of these surgical procedures compared with medical management and with each other are uncertain. OBJECTIVES: To assess the effects of surgery for morbid obesity. SEARCH STRATEGY: Studies were obtained from computerized searches of multiple electronic bibliographic databases, supplemented with hand searches of selected journals and consultation with experts in obesity research. Date of the most recent searches: December 2004. SELECTION CRITERIA: Randomised controlled trials comparing different surgical procedures, and randomised controlled trials and prospective cohort studies comparing surgery with non-surgical management for morbid obesity. DATA COLLECTION AND ANALYSIS: Data were extracted by one reviewer and checked independently by two reviewers. Two reviewers independently assessed trial quality. MAIN RESULTS: Twenty-six trials were included. Two randomised controlled trials and three prospective cohort studies compared surgery with non-surgical management, and 21 randomised controlled trials compared different surgical procedures. The quality of most of the trials was poor; just three trials had adequate allocation concealment. A meta-analysis was not possible due to differences in the surgical procedures performed, measures of weight change and length of follow-up. Compared with conventional management, surgery resulted in greater weight loss (21 kg weight loss at eight years versus weight gain), with improvements in quality of life and comorbidities. Some complications of surgery occurred, such as wound infection. Gastric bypass was associated with greater weight loss, better quality of life and fewer revisions, reoperations and/or conversions than gastroplasty, but had more side-effects. Greater weight loss and fewer side-effects and reoperations occurred with adjustable gastric banding than vertical banded gastroplasty, but laparoscopic vertical banded gastroplasty produced more patients with an excellent or good result and fewer late complications than laparoscopic adjustable silicone gastric banding. Vertical banded gastroplasty was associated with greater weight loss but more vomiting than horizontal gastroplasty. Some postoperative deaths occurred in the studies. Weight loss was similar between open and laparoscopic procedures. Fewer serious complications occurred with laparoscopic surgery, although conversion to open surgery was sometimes required. Most studies found that laparoscopic surgery had a longer operative time. But, it resulted in reduced blood loss and quicker recovery. AUTHORS' CONCLUSIONS: The limited evidence suggests that surgery is more effective than conventional management for weight loss in morbid obesity. The comparative safety and effectiveness of different surgical procedures is unclear.

Gastric Bypass↗
PubMed2005

Systematic review of the Sugarbaker procedure for pseudomyxoma peritonei.

BACKGROUND: Pseudomyxoma peritonei, a rare progressive disease process within the peritoneum, is characterized by an abundance of mucinous fluid; if left untreated, the condition is fatal. The aim of this article is to assess the clinical effectiveness and costs of the Sugarbaker procedure for pseudomyxoma peritonei. METHODS: A systematic review of the literature up to April 2004 was undertaken, with modelling of costs. RESULTS: Five retrospective case-series reports met the inclusion criteria. Survival after operation was approximately 95 per cent at 2 years and 60-68 per cent at 10 years, with 41-52 per cent of patients having no evidence of disease at the end of follow-up. A Monte Carlo simulation model estimated the marginal cost for one patient over a maximum of 5 years to be about pound 9700 (standard deviation pound 1300). CONCLUSION: Evidence of the effectiveness of the Sugarbaker procedure for pseudomyxoma peritonei is limited in quantity and quality, but suggests there may be some benefit for patients. The marginal cost of the operation is about pound 9700, provided that trained and experienced staff are available to perform the procedure.

Costs and Cost Analysis↗
PubMed2005

Clinical effectiveness and cost-effectiveness of immediate angioplasty for acute myocardial infarction: systematic review and economic evaluation.

OBJECTIVES: To review the clinical evidence comparing immediate angioplasty with thrombolysis, and to consider whether it would be cost-effective. DATA SOURCES: Electronic databases. Experts in the field. REVIEW METHODS: For clinical effectiveness, a comprehensive review of randomised control trials (RCTs) was used for efficacy, and a selection of observational studies such as case series or audit data used for effectiveness in routine practice. RCTs of thrombolysis were used to assess the relative value of prehospital and hospital thrombolysis. Observational studies were used to assess the representativeness of patients in the RCTs, and to determine whether different groups have different capacity to benefit. Clinical effectiveness was synthesised through a narrative review with full tabulation of results of all included studies and a meta-analysis to provide a precise estimate of absolute clinical benefit. Consideration was given to the effect of the growing use of stents. The economic modelling adopted an NHS perspective to develop a decision-analytical model of cost-effectiveness focusing on opportunity costs over the short term (6 months). RESULTS: The results were consistent in showing an advantage of immediate angioplasty over hospital thrombolysis. The updated meta-analysis showed that mortality is reduced by about one-third, from 7.6% to 4.9% in the first 6 months, and by about the same in studies of up to 24 months. Reinfarction is reduced by over half, from 7.6% to 3.1%. Stroke is reduced by about two-thirds, from 2.3% with thrombolysis to 0.7% with percutaneous coronary intervention (PCI), with the difference being due to haemorrhagic stroke. The need for coronary artery bypass graft is reduced by about one-third, from 13.2% to 8.4%. Caution is needed in interpreting some of the older trials, as changes such as an increase in stenting and the use of the glycoprotein IIb/IIa inhibitors may improve the results of PCI. There is little evidence comparing prehospital thrombolysis with immediate PCI. Research on thrombolysis followed by PCI, known as 'facilitated PCI', is underway, but results are not yet available. Trials may be done in select centres and results may not be as good in lower volume centres, or out of normal working hours. In addition, much of the marginal mortality benefit of PCI over hospital thrombolysis may be lost if door-to-balloon time were more than an hour longer than door-to-needle time. Conversely, within the initial 6 hours, the later patients present, the greater the relative advantage of PCI. Results suggest that PCI is more cost-effective than thrombolysis, providing additional benefits in health status at some extra cost. In the longer term, the cost difference is expected to be reduced because of higher recurrence and reintervention rates among those who had thrombolysis. CONCLUSIONS: If both interventions were routinely available, the economic analysis favours PCI, given the assumptions of the model. However, very few units in England could offer a routine immediate PCI service at present, and there would be considerable resource implications of setting up such services. Without a detailed survey of existing provision, it is not possible to quantify the implications, but they include both capital and revenue: an increase in catheter laboratory provision and running costs. The greatest problem would be staffing, and that would take some years to resolve. A gradual incrementalist approach based on clinical networks, with transfer to centres able to offer PCI, may be used. In rural areas, one option may be to promote an increase in prehospital thrombolysis, with PCI for thrombolysis failures. There is a need for data on the long-term consequences of treatment, the quality of life of patients after treatment, and the effects of PCI following thrombolysis failure.

Angioplasty↗
PubMed2005

The clinical and cost-effectiveness of left ventricular assist devices for end-stage heart failure: a systematic review and economic evaluation.

OBJECTIVES: To assess the clinical and cost-effectiveness of left ventricular assist devices (LVADs) as a bridge to heart transplantation (BTT), as a bridge to myocardial recovery (BTR) or as a long-term chronic support (LTCS) for people with end-stage heart failure (ESHF). DATA SOURCES: For the systematic review, electronic databases and bibliographies of related publications plus experts and manufacturers. For the economic evaluations, data originated from the systematic review of clinical and cost-effectiveness, UK hospitals, device manufacturers and expert opinion. REVIEW METHODS: For the systematic review, studies were selected and assessed against a set of rigorous criteria; data were then synthesised using a narrative approach through subgroup analysis based on the indication for treatment, type of LVAD and quality of studies. The economic evaluation developed two models to evaluate the use of LVADs, first as a BTT and second as LTCS for patients suffering from ESHF. RESULTS: Sixteen studies assessed the clinical effectiveness of LVADs as a BTT. Despite the poor methodological quality of the evidence, LVADs appeared beneficial compared to other treatment options (i.e. inotropic agents or usual care) or to no care (i.e. the natural history of ESHF) improving the survival of people with ESHF during the period of support and following heart transplantation. Patients supported by an LVAD appeared to have an improved functional status compared with those on usual care and experienced an improvement in their quality of life from before device implantation to the period during support. Serious adverse events are a risk for patients with an LVAD. With a scarcity of evidence directly comparing different devices, it is difficult to identify specific devices as the most clinically effective. The HeartMate LVAD is the only device that has evidence comparing it with the different alternatives, appearing to be more clinically effective than inotropic agents and usual care and as clinically effective as the Novacor device. Second generation devices, such as Jarvik 2000 and MicroMed Debakey LVADs, are early in their development but show considerable promise that should be assessed through long-term studies. Evidence of the clinical effectiveness of LVADs as a BTR was limited to seven non-comparative observational studies that appeared to show that the LVADs were beneficial in providing support until myocardial recovery. It was not possible to assess whether the LVADs are more effective than other alternatives or specific devices. No evidence was found on the quality of life or functional status of patients and limited information on adverse events was reported. Six studies assessed the clinical effectiveness of LVADs as an LTCS and from these it was evident that LVADs provided benefits in terms of improved survival, functional status and quality of life. Nineteen studies assessed the costs and cost-effectiveness of LVADS for people with ESHF, with the majority being simple costing studies and very few studies of the cost-effectiveness of LVADs. With no relevant cost-effectiveness studies available, an economic evaluation for BTT and LTCS was developed. The economic evaluation has shown that neither LVAD indication considered, that is, BTT and LTCS, is a cost-effective use. For the HeartMate LVAD used as a BTT the cost per QALY was pound 65,242. In the less restrictive indication, LTCS, where LVADs are not just given to patients awaiting transplantation, the analysis has shown that LTCS is not cost-effective. The baseline cost per QALY of the first-generation HeartMate LVAD was pound 170,616. One- and multi-way sensitivity analysis had limited effect on the cost per QALY. A hypothetical scenario based on the cost of a second-generation MicroMed DeBakey device illustrated that a 60% improvement in survival over first-generation devices was necessary before the incremental cost-effectiveness approached pound 40,000 per QALY. CONCLUSIONS: Although the review showed that LVADs are clinically effective as a BTT with ESHF, the economic evaluation indicated that they are not cost-effective. With the limited and declining availability of donor hearts for transplantation, it appears that the future of the technology is in its use as an LTCS. Further research is needed to examine the clinical effectiveness of LVADs for people with ESHF, assessing patient survival, functional ability, quality of life and adverse events. Evaluations of the clinical effectiveness of LVADs should include economic evaluations, as well as data on quality of life, utilities, resources and costs. A systematic review of the epidemiology of ESHF should be undertaken to assess its potential impact.

Cost-Benefit Analysis↗
PubMed2004

Inhaled insulin in diabetes mellitus.

BACKGROUND: Insulin therapy often relies on multiple daily injections of insulin. However this is a considerable burden to many people with diabetes and adherence to such an insulin regimen can be difficult to maintain, hence compromising optimal glycaemic control. Also, short acting injected insulin is absorbed more slowly than insulin released by the normal pancreas in response to a meal. Inhaled insulin has the potential to reduce the number of injections to perhaps one long-acting insulin per day, and provide a closer match to the natural state, by more rapid absorption from the lung. OBJECTIVES: To compare the efficacy, adverse effects and patient acceptability of inhaled versus injected insulin. SEARCH STRATEGY: A sensitive search strategy for randomised controlled or cross-over trials was combined with key terms for inhaled insulins. Databases searched were: The Cochrane Library, MEDLINE, PubMed, EMBASE, Science Citation Index, BIOSIS, Web of Science Proceedings, National Research Register UK, Current Controlled Trials, ClinicalTrials.gov, Conference Papers Index, LexisNexis, and web sites of the ADA and EASD were searched for recent meeting abstracts. Reference lists and journals were handsearched. There were no language restrictions on searching. Manufacturers of inhaled insulin were also contacted. Date of last search October 2002. SELECTION CRITERIA: Only randomised controlled trials with parallel groups or controlled cross-over trials, including type 1 or type 2 diabetic patients of any age treated with insulin, were considered eligible. The minimum trial duration considered was 10 weeks, as this is the time taken for glycated haemoglobin to reliably reflect changes in glycaemic control. DATA COLLECTION AND ANALYSIS: Trial selection and evaluation of study quality was performed independently by two reviewers. The quality of reporting of each trial was assessed according to a modification of the criteria outlined in Centre for Reviews and Dissemination (CRD) Report 4, Spitzer; and Jadad. MAIN RESULTS: Six randomised controlled trials were found and the overall number of participants was 1191. Three trials included patients with type 1 diabetes and three with type 2 diabetes. Three trials had a duration of 24 weeks, and three of 12 weeks. All were open label. There was insufficient information to determine the study quality. Results for HbA1c were similar for all trials, in that all showed comparable glycaemic control for inhaled insulin compared to an entirely subcutaneous regimen. All trials that reported patient satisfaction and quality of life showed that these were significantly greater in the inhaled insulin group. Overall there was no difference in total hypoglycaemic episodes between the groups, but one trial showed a statistically significant increase in severe hypoglycaemic episodes for the inhaled insulin group. No adverse pulmonary effects were observed in any of the studies, but longer follow-up will be required to be sure that there are no adverse side-effects. Cavets include: few studies published in full (so quality could not be assessed), and only two studies used the same basal regimen in both the inhaled and injected groups. REVIEWERS' CONCLUSIONS: Inhaled insulin taken before meals, in conjunction with an injected basal insulin, has been shown to maintain glycaemic control comparable to that of patients taking multiple daily injections. The key benefit appears to be that patient satisfaction and quality of life are significantly improved, presumably due to the reduced number of daily injections required. However, the patient satisfaction data is based on five trials, of which only two have been published in full; also the three trials containing quality of life data are all only published in abstract form at present. In addition, longer term pulmonary safety data are still needed. Also, the lower bioavailability, and hence higher doses of inhaled insulin required, may make it less cost-effective than injected insulin.

Administration, Inhalation↗
PubMed2004

Clinical effectiveness and costs of the Sugarbaker procedure for the treatment of pseudomyxoma peritonei.

OBJECTIVES: This systematic review examines the clinical and cost-effectiveness of the Sugarbaker procedure for treating pseudomyxoma peritonei (PMP) and the costs of the procedure in the UK. DATA SOURCES: Electronic databases, bibliographies of related papers and experts in the field were used as sources for English language studies available up to September 2002. REVIEW METHODS: Evidence of the clinical effectiveness of the Sugarbaker procedure for PMP was synthesised through a narrative review with full tabulation of results of all included studies. The economic modelling used a Monte-Carlo simulation model populated with UK price data to estimate likely UK costs. RESULTS: Five retrospective case-series reports assessing the Sugarbaker procedure met the inclusion criteria for the review, although they were found to be of poor quality when judged against standard criteria for assessing methodological standard. There appears to be some benefit for people with PMP who undergo treatment with the Sugarbaker procedure. Commonly reported complications of the Sugarbaker procedure were anastomotic leaks, fistula formation, wound infection, small bowel perforations/obstructions and pancreatitis. One costing study of poor methodological quality and set in the USA was found. This study, together with UK unit price data and expert advice, was used to populate a Monte-Carlo simulation model to estimate the marginal cost of operating a service to provide treatment for PMP using the Sugarbaker technique rather than standard treatment. The results of the Monte-Carlo simulation model showed that the cost for one patient over a maximum of 5 years would be about 9700 British pounds, with a standard deviation of about 1300 British pounds (although costs incurred in setting up the specific service or training the staff were not included). The US study showed a ten-fold higher cost. The Monte-Carlo analysis showed that the variation around the mean was not very high. The most likely factor influencing the variation of the costs was the length of procedure. No sensitivity analysis could be done of the alternative treatment. CONCLUSIONS: The economic results should be seen as merely an example of the likely marginal costs of the Sugarbaker procedure, as more information about the current alternative is required. Trained and experienced staff are required to implement the procedure and inevitably time and cost will be involved in developing the appropriate teams. Although the procedure requires some specialist equipment and maintenance, such as smoke evacuators, these should have limited effect on setting up the service. PMP is a relatively rare condition with approximately 50 new cases per year in the UK and the impact of an increase in the demand for services should be limited. Evidence is needed for the effectiveness of maximal cytoreductive surgery compared with surgical debulking, using different intraoperative intraperitoneal chemotherapy strategies, and for the effectiveness of treatments in patients who have residual disease following maximal efforts at cytoreduction. Further research involving high-quality prospective cohort studies with economic evaluations would be valuable.

Adult↗
PubMed2003

Specialist nurses in diabetes mellitus.

BACKGROUND: The patient with diabetes has many different learning needs relating to diet, monitoring, and treatments. In many health care systems specialist nurses provide much of these needs, usually aiming to empower patients to self-manage their diabetes. The present review aims to assess the effects of the involvement of specialist nurse care on outcomes for people with diabetes, compared to usual care in hospital clinics or primary care with no input from specialist nurses. OBJECTIVES: To assess the effects of diabetes specialist nurses / nurse case manager in diabetes on the metabolic control of patients with type 1 and type 2 diabetes mellitus. SEARCH STRATEGY: We carried out a comprehensive search of databases including the Cochrane Library, MEDLINE and EMBASE to identify trials. Bibliographies of relevant papers were searched, and hand searching of relevant publications was undertaken to identify additional trials (Date of last search November 2002). SELECTION CRITERIA: Randomised controlled trials and controlled clinical trials of the effects of a specialist nurse practitioner on short and long term diabetic outcomes were included in the review. DATA COLLECTION AND ANALYSIS: Three investigators performed data extraction and quality scoring independently; any discrepancies were resolved by consensus. MAIN RESULTS: Six trials including 1382 participants followed for six to 12 months were included. Two trials were in adolescents. Due to substantial heterogeneity between trials a meta-analysis was not performed. Glycated haemoglobin (HbA1c) in the intervention groups was not found to be significantly different from the control groups over a 12 month follow up period. One study demonstrated a significant reduction in HbA1c in the presence of the diabetes specialist nurse/nurse case manager at 6 months. Significant differences in episodes of hypoglycaemia and hyperglycaemia between intervention and control groups were found in one trial. Where reported, emergency admissions and quality of life were not found to be significantly different between groups. No information was found regarding BMI, mortality, long term diabetic complications, adverse effects, or costs. REVIEWER'S CONCLUSIONS: The presence of a diabetes specialist nurse / nurse case manager may improve patients' diabetic control over short time periods, but from currently available trials the effects over longer periods of time are not evident. There were no significant differences overall in hypoglycaemic episodes, hyperglycaemic incidents, or hospital admissions. Quality of life was not shown to be affected by input from a diabetes specialist nurse/nurse case manager.

Case Management↗
PubMed2003

Surgery for morbid obesity.

BACKGROUND: Obesity is associated with increased morbidity and mortality. Surgery for morbid obesity may be considered when other conventional measures have failed, and a number of procedures are available. However, the effects of these surgical procedures compared with medical management and with each other are uncertain. OBJECTIVES: To assess the effects of surgery for morbid obesity on weight, comorbidities and quality of life. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register (issue 4, 2001), Medline (SilverPlatter) up to 2001, PubMed (Internet) 01/01/01-19/10/01, Embase (SilverPlatter) up to 09/2001, PsychINFO up to 10/2001, CINAHL (SilverPlatter) up to 07/2001, Science and Social Sciences Citation Index up to 10/12001, British Nursing Index up to 07/2001, Web of Science Proceedings up to 06/2001, BIOSIS up to10/2001, AMED up to 07/2001, National Research Register (issue 2, 2001), reference lists of relevant articles, and handsearched relevant journals. We also contacted experts in the field. Date of the most recent searches: October 2001. SELECTION CRITERIA: Randomised controlled trials comparing different surgical procedures, and randomised controlled trials and non-randomised controlled trials comparing surgery with non-surgical management for morbid obesity. DATA COLLECTION AND ANALYSIS: Data were extracted by one reviewer and checked independently by two reviewers. Two reviewers independently assessed trial quality. MAIN RESULTS: 18 trials involving 1891 people were included. One randomised controlled trial and one non-randomised controlled trial compared surgery with non-surgical management, and 11 randomised controlled trials compared different surgical procedures. The overall quality of the trials was variable, with just one trial having adequate allocation concealment. A meta-analysis was not possible due to differences in the surgical procedures performed, measures of weight change and length of follow-up. Compared with conventional management, surgery resulted in greater weight loss (23-28 kg more weight loss at two years), with improvements in quality of life and comorbidities. Some complications of surgery occurred, such as wound infection. Gastric bypass was associated with greater weight loss and fewer revisions, reoperations and/or conversions than gastroplasty, but had more side-effects. Greater weight loss and fewer side-effects and reoperations occurred with adjustable gastric banding than vertical banded gastroplasty, while vertical banded gastroplasty was associated with greater weight loss but more vomiting than horizontal gastroplasty. Some postoperative deaths occurred in the studies. Weight loss was similar between open and laparoscopic procedures. Fewer serious complications occurred with laparoscopic surgery. Laparoscopic surgery had a longer operative time, but resulted in reduced blood loss, reduced proportion of patients requiring intensive care unit stay, reduced length of hospital stay, reduced days to return to activities of daily living and reduced days to return to work. REVIEWER'S CONCLUSIONS: The limited evidence suggests that surgery is more effective than conventional management for weight loss in morbid obesity. The comparative safety and effectiveness of different surgical procedures is unclear.

Gastric Bypass↗
PubMed2003

Inhaled insulin in diabetes mellitus.

BACKGROUND: Insulin therapy often relies on multiple daily injections of insulin. However this is a considerable burden to many people with diabetes and adherence to such an insulin regimen can be difficult to maintain, hence compromising optimal glycaemic control. Also, short acting injected insulin is absorbed more slowly than insulin released by the normal pancreas in response to a meal. Inhaled insulin has the potential to reduce the number of injections to perhaps one long-acting insulin per day, and provide a closer match to the natural state, by more rapid absorption from the lung. OBJECTIVES: To compare the efficacy, adverse effects and patient acceptability of inhaled versus injected insulin. SEARCH STRATEGY: A sensitive search strategy for randomised controlled or cross-over trials was combined with key terms for inhaled insulins. Databases searched were: The Cochrane Library, MEDLINE, PubMed, EMBASE, Science Citation Index, BIOSIS, Web of Science Proceedings, National Research Register UK, Current Controlled Trials, ClinicalTrials.gov, Conference Papers Index, LexisNexis, and web sites of the ADA and EASD were searched for recent meeting abstracts. Reference lists and journals were handsearched. There were no language restrictions on searching. Manufacturers of inhaled insulin were also contacted. Date of last search October 2002. SELECTION CRITERIA: Only randomised controlled trials with parallel groups or controlled cross-over trials, including type 1 or type 2 diabetic patients of any age treated with insulin, were considered eligible. The minimum trial duration considered was 10 weeks, as this is the time taken for glycated haemoglobin to reliably reflect changes in glycaemic control. DATA COLLECTION AND ANALYSIS: Trial selection and evaluation of study quality was performed independently by two reviewers. The quality of reporting of each trial was assessed according to a modification of the criteria outlined in Centre for Reviews and Dissemination (CRD) Report 4, Spitzer; and Jadad. MAIN RESULTS: Six randomised controlled trials were found and the overall number of participants was 1191. Three trials included patients with type 1 diabetes and three with type 2 diabetes. Three trials had a duration of 24 weeks, and three of 12 weeks. All were open label. There was insufficient information to determine the study quality. Results for HbA1c were similar for all trials, in that all showed comparable glycaemic control for inhaled insulin compared to an entirely subcutaneous regimen. All trials that reported patient satisfaction and quality of life showed that these were significantly greater in the inhaled insulin group. Overall there was no difference in total hypoglycaemic episodes between the groups, but one trial showed a statistically significant increase in severe hypoglycaemic episodes for the inhaled insulin group. No adverse pulmonary effects were observed in any of the studies, but longer follow-up will be required to be sure that there are no adverse side-effects. Cavets include: few studies published in full (so quality could not be assessed), and only two studies used the same basal regimen in both the inhaled and injected groups. REVIEWER'S CONCLUSIONS: Inhaled insulin taken before meals, in conjunction with an injected basal insulin, has been shown to maintain glycaemic control comparable to that of patients taking multiple daily injections. The key benefit appears to be that patient satisfaction and quality of life are significantly improved, presumably due to the reduced number of daily injections required. However, the patient satisfaction data is based on five trials, of which only two have been published in full; also the three trials containing quality of life data are all only published in abstract form at present. In addition, longer term pulmonary safety data are still needed. Also, the lower bioavailability, and hence higher doses of inhaled insulin required, may make it less cost-effective than injected insulin.

Administration, Inhalation↗
PubMed2003

Clinical and cost effectiveness of surgery for morbid obesity: a systematic review and economic evaluation.

OBJECTIVE: To assess the clinical and cost effectiveness of surgery for people with morbid obesity. DESIGN: A systematic review of randomised control trials (RCTs), prospective clinical trials and economic evaluations identified from 14 electronic databases (including Medline, Cochrane library and Embase from their inception to October 2001), bibliographies and consultation with experts and manufacturers was performed to assess the clinical and cost effectiveness of different surgical procedures and nonsurgical management for morbid obesity. An economic evaluation was undertaken to assess cost effectiveness in the UK. SUBJECTS: People diagnosed as morbidly obese, defined as a body mass index (BMI) (weight in kilograms/height in metres(2)) >40 kg/m(2), or with a BMI>35 kg/m(2) with serious comorbid disease, in whom previous nonsurgical interventions had failed. MEASUREMENTS: The outcomes assessed included weight change, quality of life, peri- and postoperative morbidity and mortality, revision rates and obesity comorbidities. Cost effectiveness was modelled from these data and presented as cost per quality-adjusted life year (QALY). RESULTS: Included studies differed in methodological quality. Surgery resulted in a significantly greater loss of weight (23-37 kg more weight) than nonsurgical treatment, which was maintained to 8 years and led to improvements in quality of life and comorbidities. The economic evaluation of surgery compared with nonsurgical management suggested that surgery was cost effective at pound 11000 per QALY. Comparisons of the different types of surgery were equivocal. CONCLUSION: Surgery for morbid obesity appears to be clinically and cost effective. Because of the nature of the evidence, particularly the uncertainty in the clinical and economic evaluations, it is difficult to distinguish between the different surgical procedures.

Cost-Benefit Analysis↗
PubMed2003

Are analogue insulins better than soluble in continuous subcutaneous insulin infusion? Results of a meta-analysis.

AIMS: The properties of rapid-acting insulin analogues are thought to be particularly appropriate for use in continuous subcutaneous insulin infusion (CSII) or insulin pump therapy. We conducted a systematic review and meta-analysis of trials comparing rapid-acting insulin analogues with soluble insulin in CSII. METHODS: The following databases were searched (last search June 2002): MEDLINE 1985-2002; Embase 1980-2002; PubMed internet version, records added June 2001 to June 2002; Science Citation Index 1990-2002; BIOSIS 1999-2002; Web of Science Proceedings 1990-2002; and the Cochrane Library, including DARE and the HTA databases. Randomized controlled trials and crossover studies with at least 10 weeks on each treatment were included. Data extraction and quality assessment were undertaken by one reviewer and checked by a second. A meta-analysis was undertaken using a random effects model. RESULTS: A significant improvement of 0.26% (95% confidence interval -0.47, -0.06%) in glycated haemoglobin was demonstrated with lispro. Some studies reported fewer hypoglycaemic episodes with analogue insulin but this varied according to the definitions used. No differences in insulin dosage or weight were seen. Two studies reported patient preference, with analogues preferred in both. The extra cost per annum ranges from pound 72 (at 40 units per day) to pound 150 (at 84 units per day). CONCLUSIONS: Insulin analogues result in a modest but significant reduction in HbA1c compared with soluble insulin when used in CSII, and are preferred by patients.

Cross-Over Studies↗
PubMed2003

Systematic review of endoscopic sinus surgery for nasal polyps.

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.

Endoscopy↗
PubMed2003

The clinical and cost-effectiveness of patient education models for diabetes: a systematic review and economic evaluation.

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.

Cost-Benefit Analysis↗
PubMed2003

Literature searching for clinical and cost-effectiveness studies used in health technology assessment reports carried out for the National Institute for Clinical Excellence appraisal system.

OBJECTIVE: To contribute to making searching for Technology Assessment Reports (TARs) more cost-effective by suggesting an optimum literature retrieval strategy. DATA SOURCES: A sample of 20 recent TARs. REVIEW METHODS: All sources used to search for clinical and cost-effectiveness studies were recorded. In addition, all studies that were included in the clinical and cost-effectiveness sections of the TARs were identified, and their characteristics recorded, including author, journal, year, study design, study size and quality score. Each was also classified by publication type, and then checked to see whether it was indexed in the following databases: MEDLINE, EMBASE, and then either the Cochrane Controlled Trials Register (CCTR) for clinical effectiveness studies or the NHS Economic Evaluation Database (NHS EED) for the cost-effectiveness studies. Any study not found in at least one of these databases was checked to see whether it was indexed in the Science Citation Index (SCI) and BIOSIS, and the American Society of Clinical Oncology (ASCO) Online if a cancer review. Any studies still not found were checked to see whether they were in a number of additional databases. RESULTS: The median number of sources searched per TAR was 20, and the range was from 13 to 33 sources. Six sources (CCTR, DARE, EMBASE, MEDLINE, NHS EED and sponsor/industry submissions to National Institute for Clinical Excellence) were used in all reviews. After searching the MEDLINE, EMBASE and NHS EED databases, 87.3% of the clinical effectiveness studies and 94.8% of the cost-effectiveness studies were found, rising to 98.2% when SCI, BIOSIS and ASCO Online and 97.9% when SCI and ASCO Online, respectively, were added. The median number of sources searched for the 14 TARs that included an economic model was 9.0 per TAR. A sensitive search filter for identifying non-randomised controlled trials (RCT), constructed for MEDLINE and using the search terms from the bibliographic records in the included studies, retrieved only 85% of the known sample. Therefore, it is recommended that when searching for non-RCT studies a search is done for the intervention alone, and records are then scanned manually for those that look relevant. CONCLUSIONS: Searching additional databases beyond the Cochrane Library (which includes CCTR, NHS EED and the HTA database), MEDLINE, EMBASE and SCI, plus BIOSIS limited to meeting abstracts only, was seldom found to be effective in retrieving additional studies for inclusion in the clinical and cost-effectiveness sections of TARs (apart from reviews of cancer therapies, where a search of the ASCO database is recommended). A more selective approach to database searching would suffice in most cases and would save resources, thereby making the TAR process more efficient. However, searching non-database sources (including submissions from manufacturers, recent meeting abstracts, contact with experts and checking reference lists) does appear to be a productive way of identifying further studies.

Abstracting and Indexing↗
PubMed2000

A comparison of opiate- and epidural-induced alterations in splanchnic blood flow using intra-operative gastric tonometry.

Several methods are available to measure splanchnic blood flow and gut ischaemia. Tonometry is most practical for peri-operative use. Epidural blockade from T5 to T11 causes mesenteric arteriovenous vasodilation and may increase splanchnic blood flow. This study assesses the ability of tonometry to measure differential effects of opiate and epidural analgesia on splanchnic blood flow. Forty patients for elective colorectal surgery were randomly allocated to receive epidural infusion or intravenous morphine. Gastric mucosal PCO2, pHi, standard pHi, PCO2 gap and pH gap were measured after induction and on termination of surgery. These parameters were within normal limits at the end in most cases and there was no significant difference between the groups. The complication rate was similar in both groups and was not correlated with low pHi, but was correlated with blood loss. We were unable to demonstrate a difference in splanchnic perfusion, as assessed by gastric tonometry, between the two groups.

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