Biomedical subjects

L Vale

Publications and source records attributed to L Vale.

At least 19 recordsLinked to original sources

PubMed2005

Cellulose, modified cellulose and synthetic membranes in the haemodialysis of patients with end-stage renal disease.

BACKGROUND: When the kidney fails the blood-borne metabolites of protein breakdown and water cannot be excreted. The principle of haemodialysis is that such substances can be removed when blood is passed over a semipermeable membrane. Natural membrane materials include cellulose or modified cellulose, more recently various synthetic membranes have been developed. Synthetic membranes are regarded as being more "biocompatible" in that they incite less of an immune response than cellulose-based membranes. OBJECTIVES: To assess the effects of different haemodialysis membrane material in patients with end-stage renal disease (ESRD). SEARCH STRATEGY: We searched MEDLINE, EMBASE, PreMEDLINE, HealthStar CINAHL, the Cochrane Central Register of Controlled Trials (CENTRAL), Biosis, SIGLE, CRIB, UK National Research Register and reference lists of relevant articles. We contacted biomedical companies, known investigators and handsearched selected journals and conference proceedings. Date of most recent search: June 2004. SELECTION CRITERIA: All randomised controlled trials (RCTs) or quasi-RCTs comparing different haemodialysis membrane material in patients with ESRD. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed the methodological quality of studies. Data was abstracted onto a standard form by one reviewer and checked by another. Relative Risk (RR) and weighted mean difference (WMD) with 95% confidence intervals (CI)) MAIN RESULTS: Thirty two studies were identified. Pre-dialysis ss(2) microglobulin concentrations were not significantly lower in patients treated with synthetic membranes (WMD -14.67, 95% CI -33.10 to 4.05). When analysed for change in ss(2) microglobulin, a fall was only noted with high-flux membranes. The incidence of amyloid was less in patients who were dialysed for six years with high-flux synthetic membranes (one study, RR 0.03, 95% CI 0.00 to 0.54). There was a significant difference in favour of the synthetic (high-flux) membrane in comparison to cellulose membranes for triglycerides (WMD -0.66; 95% CI -1.18 to -0.14) but not for modified cellulose membranes. Dialysis adequacy measured by Kt/V was marginally higher when cellulose membranes were used (WMD -0.10; 95% CI -0.16 to 0.04), whereas synthetic membranes achieved significantly higher Kt/V values when compared with modified cellulose membranes (WMD 0.20, 95% 0.11 to 0.29) . There were no data on quality of life measures. AUTHORS' CONCLUSIONS: We found no evidence of benefit when synthetic membranes were compared with cellulose/modified cellulose membranes in terms of reduced mortality no reduction in dialysis-related adverse symptoms. Despite the relatively large number of RCTs undertaken in this area none of the included studies reported any measures of quality of life.

Cellulose↗

PubMed2005

Recombinant human erythropoietin for chronic renal failure anaemia in pre-dialysis patients.

BACKGROUND: Treatment with recombinant human erythropoietin (rHu EPO) in dialysis patients has been shown to be highly effective in terms of correcting anaemia and improving quality of life. There is debate concerning the benefits of rHu EPO use in pre-dialysis patients which may accelerate the deterioration of renal function. However the opposing view is that if rHu EPO is as effective in pre-dialysis patient's, improving the patients sense of well-being may result in the onset of dialysis being delayed. OBJECTIVES: To assess the effects of rHu EPO use in pre-dialysis patients with renal anaemia. SEARCH STRATEGY: The initial search included 13 electronic databases (1980 to May 2001) an internet search (August 1997), handsearching of Kidney International (1983 to May 1997), contact with known investigators and biomedical companies, and reference list of relevant articles. For this update we searched the Cochrane Renal Group's specialised register (June 2004) and The Cochrane Library (Issue 3, 2004). SELECTION CRITERIA: Randomised controlled trials (RCTs) or quasi-RCTs comparing the use of rHu EPO with no treatment or placebo in pre-dialysis patients. DATA COLLECTION AND ANALYSIS: Only published data were used. Quality assessment was performed by two assessors independently. Data were abstracted by a single author onto a standard form, a sample of which was checked by another author. Results were expressed as relative risk (RR) or weighted mean difference (WMD) with 95% confidence intervals (CI). MAIN RESULTS: Fifteen trials (461 participants) were included. There was a marked improvement in haemoglobin (WMD 1.82 g/dL, 95% CI 1.35 to 2.28) and haematocrit (WMD 9.85%, 95% CI 8.35 to 11.34) with treatment and a decrease in the number of patients requiring blood transfusions (RR 0.32, 95% CI 0.12 to 0.83). The data from studies reporting quality of life or exercise capacity demonstrated an improvement in the treatment group. Most of the measures of progression of renal disease showed no statistically significant difference. No significant increase in adverse events was identified. AUTHORS' CONCLUSIONS: Treatment with rHu EPO in pre-dialysis patients corrects anaemia, avoids the requirement for blood transfusions and also improves quality of life and exercise capacity. We were unable to assess the effects of rHu EPO on progression of renal disease, delay in the onset of dialysis or adverse events. Based on the current evidence, decisions on the putative benefits in terms of quality of life are worth the extra costs of pre-dialysis rHu EPO need careful evaluation.

Anemia↗

PubMed2005

Frequency of administration of recombinant human erythropoietin for anaemia of end-stage renal disease in dialysis patients.

BACKGROUND: The benefits of recombinant human erythropoietin (rHuEPO) administration in dialysis patients have been demonstrated, however the optimal frequency regimen have yet to be established. OBJECTIVES: To assess the effects of different frequency regimens of rHuEPO administration in dialysis patients on anaemia correction, quality of life and optimal use. SEARCH STRATEGY: We searched 13 electronic databases (1980 to May 2001) the internet (August 1997), handsearched Kidney International (1983 to May 1997), contacted known investigators, biomedical companies, and screened reference lists of relevant articles. Most recent search: The Cochrane Renal Group's specialised register (June 2004) and The Cochrane Library (Issue 3, 2004). SELECTION CRITERIA: Randomised controlled trials (RCTs) or quasi-RCTs comparing different frequencies of rHuEPO administration in dialysis patients. We compared haemodialysis and CAPD patients and subcutaneous and intravenous administration. DATA COLLECTION AND ANALYSIS: Quality assessment was performed by two assessors. Data were abstracted by a single author onto a standard form, and a sample was checked by another author. Results were expressed as relative risk (RR) or weighted mean difference (WMD) with 95% confidence intervals (CI). MAIN RESULTS: Eleven studies (719 patients) were included. There was no significant difference in maintaining target haemoglobin for once versus twice weekly administration (one study, 20 patients: RR 1.00, 95% CI 0.42 to 2.40) or mean haemoglobin after 12 weeks of therapy between haemodialysis and CAPD patients (two studies: WMD -0.21 g/dL, 95% CI -0.98 to 0.56) At the end of study for once versus thrice weekly administration (three studies: SMD -0.31, 95% CI -0.67 to 0.06) and at the end of maintenance phase (one study: WMD -0.2 g/dL, 95% CI -0.65 to 0.25) there was no significant difference. More rHuEPO was required by haemodialysis patients receiving once weekly versus twice weekly doses (WMD 12.0 U/kg, 95% CI 0.24 to 23.76). No difference was found for CAPD patients alone or combined (WMD 4.38 U/kg, 95% CI -11.28 to 20.04). Once versus thrice weekly administration was not significant (WMD 10.00 U/kg, 95% CI -80.87 to 100.87). There was no difference in the frequency of adverse events. AUTHORS' CONCLUSIONS: There is no significant difference between once weekly versus thrice weekly subcutaneous administration of rHuEPO. Once weekly administration would require an additional 12 U/kg/wk for patients on haemodialysis, however this is based on one very small study. Cost of additional rHuEPO needs to assessed with regard to patient preference and compliance.

Anemia↗

PubMed2005

In vitro fertilisation for unexplained subfertility.

BACKGROUND: In vitro fertilisation (IVF) is now a widely accepted treatment for unexplained infertility (RCOG 1998). However, with estimated live-birth rates per cycle varying between 13% and 28%, its effectiveness has not been rigorously evaluated in comparison with other treatments. With increasing awareness of the role of expectant management and less invasive procedures such as intrauterine insemination, concerns about multiple complications and costs associated with IVF, it is extremely important to evaluate the effectiveness of IVF against other treatment options in couples with unexplained infertility. OBJECTIVES: The aim of this review is to determine, in the context of unexplained infertility, whether IVF improves the probability of live-birth compared with (1) expectant management, (2) clomiphene citrate (CC), (3) intrauterine insemination (IUI) alone, (4) IUI with controlled ovarian stimulation, and (5) gamete intrafallopian transfer (GIFT). SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group Trials Register (searched 23 March 2004), the Cochrane Central Register of Controlled Trials (Cochrane Library Issue 3, 2004), MEDLINE (1970 to August 2004), EMBASE (1985 to August 2004) and reference lists of articles. We also handsearched relevant conference proceedings and contacted researchers in the field. SELECTION CRITERIA: Only randomised controlled trials were included. Live-birth rate per woman was the primary outcome of interest. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed eligibility and quality of trials. MAIN RESULTS: Ten randomised controlled trials were identified. In two we could not extract data separately for unexplained infertility cases, two were non-randomised, one did not report valid rates (included in the review but not in the meta-analysis); leaving four trials for analysis. One trial compared two different interventions (IVF versus IUI with or without ovarian stimulation) and one study compared three interventions (IVF versus IUI with ovarian stimulation and GIFT). The numbers of trials assessing the effectiveness of IVF with the other treatments were as follows: IVF versus expectant management (two), IVF versus IUI (one), IVF versus IUI with ovarian stimulation (two) and IVF versus GIFT (three). Live-birth rate per woman was reported in three studies and three studies determined clinical pregnancy rate per woman. Multiple pregnancy rate was reported in three trials. Two studies reported ovarian hyperstimulation syndrome (OHSS) as an outcome measure. There were no comparative data for clomiphene citrate and no comparative data on live-birth rates for GIFT. There was no evidence of a difference in live-birth rates between IVF and IUI either without (OR 1.96; 95% CI 0.88 to 4.4) or with (OR 1.15; 95% CI 0.55 to 2.4) ovarian stimulation. There were significantly higher clinical pregnancy rates with IVF in comparison to expectant management (OR 3.24; 95% CI 1.07 to 9.80). There was no significant difference between IVF and GIFT for the one RCT that reported live-birth rates (OR 2.57; 95% CI 0.93 to 7.08). However, there was a significant difference in the clinical pregnancy rates between IVF and GIFT, with pregnancy rates greater for IVF (OR 2.14; 95% CI 1.08 to 4.2). There was no evidence of a difference in the multiple pregnancy rates between IVF and IUI with ovarian stimulation (OR 0.63; 95% CI 0.27 to 1.5), however, IVF had a higher rate than GIFT (OR 6.3; 95% CI 1.7 to 23). Clinical heterogeneity was present among the studies included. However, there was no evidence of statistical heterogeneity, which allowed the studies to be combined for statistical analysis. AUTHORS' CONCLUSIONS: Any effect of IVF relative to expectant management, clomiphene citrate, IUI with or without ovarian stimulation and GIFT in terms of live-birth rates for couples with unexplained subfertility remains unknown. The studies included are limited by their small sample size so that even large differences might be hidden. Live-birth rates are seldom reported. Periods of follow up are inadequate and unequal. Adverse effects such as multiple pregnancies and ovarian hyperstimulation syndrome have also not been reported in most studies. Larger trials with adequate power are warranted to establish the effectiveness of IVF in these women. Future trials should not only report rates per woman/couple but also include adverse effects and costs of the treatments as outcomes. Factors that have a major effect on these outcomes such as fertility treatment, female partner's age, duration of infertility and previous pregnancy history should also be considered.

Clomiphene↗

PubMed2005

Transabdominal pre-peritoneal (TAPP) versus totally extraperitoneal (TEP) laparoscopic techniques for inguinal hernia repair: a systematic review.

BACKGROUND: The choice of approach to the laparoscopic repair of inguinal hernia is controversial. There is a scarcity of data comparing the laparoscopic transabdominal preperitoneal (TAPP) approach with the laparoscopic totally extraperitoneal (TEP) approach, and questions remain about their relative merits and risks. METHODS: Electronic databases were searched to identify reports of trials comparing laparoscopic TAPP with laparoscopic TEP. In addition, selected conference proceedings were hand-searched, websites consulted, reference lists of all included papers were scanned, and experts contacted for other potentially eligible reports. All published and unpublished randomised controlled trials and quasi-randomised controlled trials comparing laparoscopic TAPP with laparoscopic TEP for inguinal hernia repair were eligible for inclusion. Large non-randomised prospective studies were also eligible for inclusion to provide further comparative evidence of complications and serious adverse events. Two reviewers independently extracted data and assessed study quality. Statistical analyses were performed using the fixed effects model and the results expressed as relative risk (RR) for dichotomous outcomes and weighted mean difference (WMD) for continuous outcomes with 95% confidence intervals (CI). RESULTS: The search identified one RCT which reported no statistically significant difference between TAPP and TEP when considering duration of operation, haematoma, length of stay, time to return to usual activities, and recurrence. The eight non-randomised studies suggest that TAPP is associated with higher rates of port-site hernias and visceral injuries whilst there appear to be more conversions with TEP. Vascular injuries and deep/mesh infections were rare and there was no obvious difference between the groups. No studies reporting economic evidence were identified. CONCLUSIONS: There is insufficient data to allow conclusions to be drawn about the relative effectiveness of TEP compared with TAPP. Efforts should be made to start and complete adequately-powered randomised controlled trials (RCTs), which compare the different methods of laparoscopic repair.

Female↗

PubMed2005

Transabdominal pre-peritoneal (TAPP) vs totally extraperitoneal (TEP) laparoscopic techniques for inguinal hernia repair.

BACKGROUND: The choice of approach to the laparoscopic repair of inguinal hernia is controversial. There is a scarcity of data comparing the laparoscopic transabdominal preperitoneal (TAPP) approach with the laparoscopic totally extraperitoneal (TEP) approach and questions remain about their relative merits and risks. OBJECTIVES: To compare the clinical effectiveness and relative efficiency of laparoscopic TAPP and laparoscopic TEP for inguinal hernia repair. SEARCH STRATEGY: We searched Medline Extra, Embase, Biosis, Science Citation Index, Cochrane Central Register of Controlled Trials (CENTRAL), Journals@ Ovid Full Text and the electronic version of the journal, Surgical Endoscopy. Recent conference proceedings by the following organisations were hand searched: Association of Endoscopic Surgeons of Great Britain & Ireland; International Congress of the European Association for Endoscopic Surgery; Scientific Session of the Society of American Gastrointestinal & Endoscopic Surgeons (SAGES); and the Italian Society of Endoscopic Surgery. In addition, specialists involved in research on the repair of inguinal hernia were contacted to ask for information about any further completed and ongoing trials, relevant websites were searched and reference lists of the all included studies were checked for additional reports. SELECTION CRITERIA: All published and unpublished randomised controlled trials and quasi-randomised controlled trials comparing laparoscopic TAPP with laparoscopic TEP for inguinal hernia repair were eligible for inclusion. Non-randomised prospective studies were also eligible for inclusion to provide further comparative evidence of complications and adverse events. DATA COLLECTION AND ANALYSIS: Statistical analyses were performed using the fixed effects model and the results expressed as relative risk (RR) for dichotomous outcomes and weighted mean difference (WMD) for continuous outcomes with 95% confidence intervals (CI). MAIN RESULTS: The search identified one RCT which reported no statistical difference between TAPP and TEP when considering duration of operation, haematoma, length of stay, time to return to usual activity and recurrence. The eight non-randomised studies suggest that TAPP is associated with higher rates of port-site hernias and visceral injuries whilst there appear to be more conversions with TEP. Vascular injuries and deep/mesh infections were rare and there was no obvious difference between the groups. No studies reporting economic evidence were identified. Very limited data were available on learning effects but these data suggest that operators become experienced at between 30 and 100 procedures. AUTHORS' CONCLUSIONS: There is insufficient data to allow conclusions to be drawn about the relative effectiveness of TEP compared with TAPP. Efforts should be made to start and complete adequately powered RCTs, which compare the different methods of laparoscopic repair.

Hernia, Inguinal↗

PubMed2005

'Spiking' as a rapid method for differentiation of Candida albicans from other yeast species.

This paper describes a simple and rapid method for the differentiation of Candida albicans from other yeast species in primary cultures based on colonial morphology following incubation in carbon dioxide. The technique has superior sensitivity to the traditional germ-tube method and requires no additional laboratory tests. In a busy laboratory, this can result in significant savings in cost and time, as well as improvements in patient care.

Agar↗

PubMed2005

Clinical quiz.

Explore the source record for details and available documents.

Diagnosis, Differential↗

PubMed2005

Quality of life before and after intensive care.

Quality of life is often thought to be poor before and after intensive care unit admission. The aim of this study was to investigate changes in quality of life before and after intensive care. A prospective cohort study of 300 consecutive patients admitted to intensive care was performed in a Scottish Teaching Hospital. Quality of life was assessed premorbidly and 3, 6 and 12 months after intensive care admission for surviving patients using SF-36 as well as EQ-5D scores at 12 months. The median value for age was 60.5 years and for APACHE II score, 18. The mean length of stay was 6.7 days. SF-36 physical component scores decreased from premorbid values at 3 months (p = 0.05) and then returned to premorbid values at 12 months (p < 0.001). The mean physical scores were below the population norm at all time points but the mean mental scores were similar or higher than these population norms. Patients who died after intensive care discharge had lower quality of life scores than did survivors (all p < 0.01). Poor premorbid quality of life was demonstrated and appears to reduce after ICU discharge. For survivors there was a slow increase in physical quality of life to premorbid levels by the end of the first year but these remained lower than in the general population. ICU patients experience a considerable longer-term burden of ill health.

APACHE↗

PubMed2005

Laparoscopic surgery for inguinal hernia repair: systematic review of effectiveness and economic evaluation.

OBJECTIVES: To determine whether laparoscopic methods are more effective and cost-effective than open mesh methods of inguinal hernia repair, and then whether laparoscopic transabdominal preperitoneal (TAPP) repair is more effective and cost-effective than laparoscopic totally extraperitoneal (TEP). DATA SOURCES: Electronic databases. Conference proceedings. Manufacturers' submissions to the National Institute for Clinical Excellence (NICE) were reviewed. REVIEW METHODS: Selected studies were rigorously assessed. Dichotomous outcome data were combined using the relative risk method and continuous outcomes were combined using the Mantel-Haenszel weighted mean difference method. Time to return to usual activities was described using hazard ratios derived from individual patient data reanalysis. A review of economic evaluations undertaken by NICE in 2001 was updated and an economic evaluation was performed. The estimation of cost-effectiveness focused on the comparison of laparoscopic repair with open flat mesh. A Markov model incorporating the data from the systematic review was used to estimate cost-effectiveness for a time horizon up to 25 years. RESULTS: Thirty-seven randomised control trials (RCTs) and quasi-RCTs met the inclusion criteria on effectiveness. Fourteen studies were included in the review of economic evaluations. Laparoscopic repair was associated with a faster return to usual activities and less persisting pain and numbness. There also appeared to be fewer cases of wound/superficial infection and haematoma. However, operation times are longer and there appears to be a higher rate of serious complications in respect of visceral (especially bladder) injuries. Mesh infection is very uncommon with similar rates noted between the surgical approaches. There is no apparent difference in the rate of hernia recurrence. Laparoscopic repair was more costly to the health service than open repair, with an estimated extra cost from studies conducted in the UK of about 300-350 pounds per patient. The point estimates of cost provided by the economic model also suggest that the laparoscopic techniques are more costly (approximately 100-200 pounds more per patient after 5 years). From the review of economic evaluations, the estimates of incremental cost per additional day at usual activities were between 86 pounds and 130 pounds. Where productivity costs were included, they eliminated the cost differential between laparoscopic and open repair. Additional analysis incorporating new trial evidence suggested that TEP was associated with significantly more recurrences than open mesh but these data did not greatly influence cost-effectiveness. CONCLUSIONS: For the management of unilateral hernias, the base-case analysis and most of the sensitivity analysis suggest that open flat mesh is the least costly option but provides less quality adjusted life years (QALYs) than TEP or TAPP. TEP is likely to dominate TAPP (on average TEP is estimated to be less costly and more effective). It is likely that, for management of symptomatic bilateral hernias, laparoscopic repair would be more cost-effective as differences in operation time (a key cost driver) may be reduced and differences in convalescence time are more marked (hence QALYs will increase) for laparoscopic compared with open mesh repair. When possible repair of contralateral occult hernias is taken into account, TEP repair is most likely to be considered cost-effective at threshold values for the cost per additional QALY above 20,000 pounds. The increased adoption of laparoscopic techniques may allow patients to return to usual activities faster. This may, for some people, reduce any loss of income. For the NHS, increased use of laparoscopic repair would lead to an increased requirement for training and the risk of serious complications may be higher. Chronic pain should now be addressed prospectively using standard definitions and allowing assessment of the degree of pain. More evidence is required on the loss of utility caused by persisting pain and numbness, as well as serious complications resulting from minor surgery. Prospective population-based registries of new surgical procedures may be the best way to address this, as a complement to randomised trials assessing effectiveness. Further research relating to whether the balance of advantages and disadvantages changes when hernias are recurrent or bilateral is also required as current data are limited. Methodologically sound RCTs are needed to consider the relative merits and risks of TAPP and TEP. Further methodological research is required into the complexity of laparoscopic groin hernia repair and the improvement of performance that accompanies experience.

Cost-Benefit 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↗

PubMed2004

Continuous ambulatory peritoneal dialysis (CAPD) versus hospital or home haemodialysis for end-stage renal disease in adults.

BACKGROUND: Renal replacement therapy (RRT) with dialysis and transplantation is the only means of sustaining life for patients with end-stage renal disease (ESRD). Although transplantation is the treatment of choice, the number of donor kidneys are limited and transplants may fail. Hence many patients require long-term or even life-long dialysis. Continuous ambulatory peritoneal dialysis (CAPD) is an alternative to hospital or home haemodialysis for patients with ESRD. OBJECTIVES: To assess the benefits and harms of CAPD versus hospital or home haemodialysis for adults with ESRD. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL in The Cochrane Library), the Cochrane Renal Group's specialised register, MEDLINE (1966 - May 2002), EMBASE (1980 - May 2002), BIOSIS, CINAHL, SIGLE and NRR without language restriction. Reference lists of retrieved articles and conference proceedings were searched and known investigators and biomedical companies were contacted. Date of most recent search January 2004. SELECTION CRITERIA: Randomised controlled trials (RCTs) or quasi-RCTs comparing CAPD to hospital or home haemodialysis for adults with ESRD were to be included. DATA COLLECTION AND ANALYSIS: Two reviewers independently assess the methodological quality of studies. Data was abstracted from included studies onto a standard form by one reviewer and checked by another. Statistical analyses were performed using the random effects model and the results expressed as relative risk (RR) for dichotomous outcomes and weighted mean difference (WMD) for continuous outcomes with 95% confidence intervals (CI). MAIN RESULTS: One trial, reported in abstract form only, was located in the most recent search. There was no statistical difference in death or quality adjusted life years score at 2 years between peritoneal dialysis or haemodialysis patients. REVIEWERS' CONCLUSIONS: There is Insufficient data to allow conclusions to be drawn about the relative effectiveness of CAPD compared with hospital or home haemodialysis for adults with ESRD. Efforts should be made to start and complete adequately powered RCTs, which compare the different dialysis modalities.

Adult↗

PubMed2004

Effectiveness and efficiency of guideline dissemination and implementation strategies.

OBJECTIVES: To undertake a systematic review of the effectiveness and costs of different guideline development, dissemination and implementation strategies. To estimate the resource implications of these strategies. To develop a framework for deciding when it is efficient to develop and introduce clinical guidelines. DATA SOURCES: MEDLINE, Healthstar, Cochrane Controlled Trial Register, EMBASE, SIGLE and the specialised register of the Cochrane Effective Practice and Organisation of Care (EPOC) group. REVIEW METHODS: Single estimates of dichotomous process variables were derived for each study comparison based upon the primary end-point or the median measure across several reported end-points. Separate analyses were undertaken for comparisons of different types of intervention. The study also explored whether the effects of multifaceted interventions increased with the number of intervention components. Studies reporting economic data were also critically appraised. A survey to estimate the feasibility and likely resource requirements of guideline dissemination and implementation strategies in UK settings was carried out with key informants from primary and secondary care. RESULTS: In total, 235 studies reporting 309 comparisons met the inclusion criteria; of these 73% of comparisons evaluated multifaceted interventions, although the maximum number of replications of a specific multifaceted intervention was 11 comparisons. Overall, the majority of comparisons reporting dichotomous process data observed improvements in care; however, there was considerable variation in the observed effects both within and across interventions. Commonly evaluated single interventions were reminders, dissemination of educational materials, and audit and feedback. There were 23 comparisons of multifaceted interventions involving educational outreach. The majority of interventions observed modest to moderate improvements in care. No relationship was found between the number of component interventions and the effects of multifaceted interventions. Only 29.4% of comparisons reported any economic data. The majority of studies only reported costs of treatment; only 25 studies reported data on the costs of guideline development or guideline dissemination and implementation. The majority of studies used process measures for their primary end-point, despite the fact that only three guidelines were explicitly evidence based (and may not have been efficient). Respondents to the key informant survey rarely identified existing budgets to support guideline dissemination and implementation strategies. In general, the respondents thought that only dissemination of educational materials and short (lunchtime) educational meetings were generally feasible within current resources. CONCLUSIONS: There is an imperfect evidence base to support decisions about which guideline dissemination and implementation strategies are likely to be efficient under different circumstances. Decision makers need to use considerable judgement about how best to use the limited resources they have for clinical governance and related activities to maximise population benefits. They need to consider the potential clinical areas for clinical effectiveness activities, the likely benefits and costs required to introduce guidelines and the likely benefits and costs as a result of any changes in provider behaviour. Further research is required to: develop and validate a coherent theoretical framework of health professional and organisational behaviour and behaviour change to inform better the choice of interventions in research and service settings, and to estimate the efficiency of dissemination and implementation strategies in the presence of different barriers and effect modifiers.

Cost-Benefit Analysis↗

PubMed2004

Does early imaging influence management and improve outcome in patients with low back pain? A pragmatic randomised controlled trial.

OBJECTIVES: To establish whether the early use of sophisticated imaging techniques influences the clinical management and outcome of patients with low back pain (LBP) and whether it is cost-effective. DESIGN: A pragmatic multicentre randomised controlled trial using a standard two parallel group approach incorporating an economic evaluation. For a subgroup of trial participants, a controlled 'before and after' approach was used to assess the impact of 'early imaging' on clinicians' diagnostic and therapeutic confidence. SETTING AND PARTICIPANTS: A total of 782 participants who had been referred by their general practitioner to a consultant orthopaedic specialist or neurosurgeon because of symptomatic lumbar spine disorders. The study included 14 hospitals in Scotland and one in England over a 24-month period. RESULTS: Participants in both groups reported an improvement in health status at 8 and 24 months with the 'early imaging' group having statistically significantly better outcome. Other than the proportion of participants receiving imaging (90% versus 30%), there were few differences between the groups in the management received throughout the 24-month follow-up. The total number of outpatient consultations in the two groups was similar although more people in the 'early imaging' group had return outpatient appointments during the 8-month follow-up. Clinicians' diagnostic confidence, between trial entry and follow-up, increased significantly for both groups with a greater increase in the 'early imaging' group. The cost of imaging was the main determinant of the difference in total costs between the groups and it was estimated that 'early imaging' could provide an additional 0.07 quality-adjusted life-years (QALYs), at an additional average cost of 61 British pounds over the 24-month follow-up. Using non-imputed costs and QALYs but adjusted for baseline differences in EQ-5D score, the mean incremental cost per QALY of 'early imaging' was 870 British pounds. The results were sensitive to the costs of imaging and the confidence intervals surrounding estimates of average costs and QALYs. CONCLUSIONS: The early use of sophisticated imaging does not appear to affect management overall but does result in a slight improvement in clinical outcome at an estimated cost of 870 British pounds per QALY. Imaging was associated with an increase in clinicians' diagnostic confidence, particularly for non-specialists. Further research is required to determine if more rapid referral to sophisticated imaging and secondary care is important in the acute episode and whether the use of imaging would be more beneficial for particular categories of LBP.

Adult↗

PubMed2004

Systematic review of the effectiveness and cost-effectiveness, and economic evaluation, of myocardial perfusion scintigraphy for the diagnosis and management of angina and myocardial infarction.

OBJECTIVES: To assess the effectiveness and cost-effectiveness of single photon emission computed tomography (SPECT) myocardial perfusion scintigraphy for the diagnosis and management of angina and myocardial infarction (MI). DATA SOURCES: Major electronic databases. REVIEW METHODS: Two reviewers independently extracted data and assessed study quality. A decision tree model was used to model the diagnosis decision and a Markov model was developed for the management of patients with suspected coronary artery disease. Costs for the treatments and interventions within strategies were derived from the literature and expressed in 2001-02 pounds sterling. Quality-adjusted life-year (QALY) weights for the different Markov model states were also obtained from the literature. RESULTS: Twenty-one diagnostic and 46 prognostic studies were included, plus two studies comparing SPECT with electrocardiography (ECG)-gated SPECT and one study comparing SPECT with attenuation-corrected SPECT. The diagnostic values of SPECT were generally higher than those of stress ECG, indicating that SPECT provided a better diagnostic performance. SPECT also provided higher positive and lower negative likelihood ratios than stress ECG but heterogeneity was evident among studies. The subgroup of studies including patients with previous MI tended to report a better diagnostic performance for SPECT than stress ECG, but there were too few studies to assess this reliably. The extent and size of the perfusion defect, and whether reversible or fixed, were important factors in predicting future cardiac events such as cardiac death or non-fatal MI. SPECT may be able to identify lower risk patients for whom coronary angiography (CA) might be avoided. Normal SPECT scans were associated with a benign prognosis and the option of medical rather than invasive management. Four studies of patients post-MI reported SPECT to be valuable in stratifying patients into at-risk groups for further cardiac events. The two studies comparing SPECT with ECG-gated SPECT, one diagnostic and the other prognostic, found in favour of gated SPECT. The study comparing SPECT with attenuation-corrected SPECT reported the latter to be more accurate. The systematic review of economic evaluations indicated that strategies involving SPECT were likely either to be dominant or to produce more QALYs at an acceptable cost. There was less agreement about which of the strategies involving SPECT was optimal. The model suggested that, for low prevalence, the incremental cost per unit of output (true positives diagnosed, accurate diagnosis, QALY) for the move from stress ECG-SPECT-CA and from stress ECG-CA to SPECT-CA might be considered worthwhile. Even after allowing for different values for sensitivity or specificity, the least costly and least effective strategy was stress ECG-SPECT-CA. The sensitivity analysis suggested that the cost-effectiveness of SPECT-CA improved if it was assumed that SPECT results allowed for the adoption of a management strategy without recourse to CA. As the time horizon reduced, the incremental cost per QALY increased (as the cost of initial diagnosis and treatment were not offset by survival and quality of life gains). CONCLUSIONS: There was a considerable variability in terms of measurement of outcomes, management, setting and patient characteristics, however the direction of evidence tended to favour SPECT in terms of test sensitivity, although these conclusions are based on a relatively small number of diagnostic studies. SPECT, in a variety of settings and patient populations, provided valuable independent and incremental prognostic information to that provided by stress ECG and/or CA that helped to risk-stratify patients and influence the way in which their condition was managed. However, all of the prognostic studies were observational studies and may be biased by unknown confounding factors. Although the ECG-gated and attenuation-corrected SPECT findings seem promising, it is difficult to draw conclusions from so few studies. Further research is needed on the effectiveness and cost-effectiveness, diagnostically and prognostically, of (a) gated and attenuation-corrected SPECT compared with standard SPECT, (b) standard SPECT compared with stress echocardiography and (c) the uncertainty surrounding the results presented in the cost-effectiveness analysis.

Angina Pectoris↗

PubMed2003

Assessing the costs and consequences of laparoscopic vs. open methods of groin hernia repair: a systematic review.

BACKGROUND: We aimed to provide unbiased estimates of cost-effectiveness by systematically reviewing published cost and cost-effectiveness data derived from studies with rigorous designs that compared laparoscopic with open groin hernia repair. METHODS: Studies reporting costs and outcomes were identified as part of a systematic review of randomized controlled trials comparing laparoscopic with open repair. The quality of the included studies was assessed against a standard checklist. Cost per recurrence avoided and cost per additional day at usual activities were estimated. RESULTS: Fourteen studies were identified. Laparoscopic repair was less efficient than open mesh repair in terms of avoiding recurrences, avoided but it had a modest cost per additional day back at usual activities. Laparoscopic repair is more likely to be efficient when compared with open nonmesh repair. CONCLUSION: The type of open repair with which laparoscopic repair is compared influences its cost-effectiveness. The earlier return to usual activities provided by laparoscopic repair may make it worthwhile in some circumstances.

Cost-Benefit Analysis↗

PubMed2003

Continuous ambulatory peritoneal dialysis (CAPD) versus hospital or home haemodialysis for end-stage renal disease in adults.

BACKGROUND: Renal replacement therapy (RRT) with dialysis and transplantation is the only means of sustaining life for patients with end-stage renal disease (ESRD). Although transplantation is the treatment of choice, the number of donor kidneys are limited and transplants may fail. Hence many patients require long-term or even life-long dialysis. Continuous ambulatory peritoneal dialysis (CAPD) is an alternative to hospital or home haemodialysis for patients with ESRD. OBJECTIVES: To assess the benefits and harms of CAPD versus hospital or home haemodialysis for adults with ESRD. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register (Cochrane Library, Issue 2, 2002), the Cochrane Renal Group's Specialised Register (May 2002), MEDLINE (1966 - May 2002), EMBASE (1980 - May 2002), BIOSIS, CINHAL, SIGLE and NRR without language restriction. Reference lists of retrieved articles and conference proceedings were searched and known investigators and biomedical companies were contacted. SELECTION CRITERIA: Randomised controlled trials (RCTs) or quasi-RCTs comparing CAPD to hospital or home haemodialysis for adults with ESRD were to be included. DATA COLLECTION AND ANALYSIS: Two reviewers were to independently assess the methodological quality of studies. Data was to be abstracted from included studies onto a standard form by one reviewer and checked by another. Statistical analyses were to be performed using the random effects model and the results to be expressed as relative risk (RR) with 95% confidence intervals (95% CI). MAIN RESULTS: Despite extensive searching, no RCTs or quasi-RCTs were identified. REVIEWER'S CONCLUSIONS: Data are not available to allow conclusions to be drawn about the relative effectiveness of CAPD compared with hospital or home haemodialysis for adults with ESRD. Efforts should be made to start and complete adequately powered RCTs, which compare the different dialysis modalities.

Adult↗

PubMed2003

Metal on metal hip resurfacing arthroplasty. An economic analysis.

This paper explores the cost utility of metal-on-metal hip resurfacing arthroplasty (MOM) as an alternative intervention to total hip replacement or 'watchful waiting' for patients with advanced hip disease. Early implant failure among younger and more active elderly patients can mean that the use of total hip replacement (THR) is delayed, with patients managed through 'watchful waiting', a combination of pain control and other non-surgical interventions. Information on costs is combined with evidence on effectiveness from a systematic review in a Markov model in order to estimate the incremental cost per quality adjusted life year (QALY) of MOM relative to THR and 'watchful waiting'.

Journal Article↗