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Biomedical subjects

L Vale

Publications and source records attributed to L Vale.

At least 37 records · Page 2Linked to original sources
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↗
PubMed2003

Systematic reviews of the effectiveness of quality improvement strategies and programmes.

Systematic reviews provide the best evidence on the effectiveness of healthcare interventions including quality improvement strategies. The methods of systematic review of individual patient randomised trials of healthcare interventions are well developed. We discuss methodological and practice issues that need to be considered when undertaking systematic reviews of quality improvement strategies including developing a review protocol, identifying and screening evidence sources, quality assessment and data abstraction, analytical methods, reporting systematic reviews, and appraising systematic reviews. This paper builds on our experiences within the Cochrane Effective Practice and Organisation of Care (EPOC) review group.

Canada↗
PubMed2003

Systematic review of the clinical effectiveness and cost-effectiveness of tension-free vaginal tape for treatment of urinary stress incontinence.

OBJECTIVES: To evaluate the effectiveness and cost-effectiveness of tension-free vaginal tape (TVT) in comparison with the standard surgical interventions currently used. DATA SOURCES: Literature searches were carried out on electronic databases and websites for data covering the period 1966--2002. Other sources included references lists of relevant articles; selected experts in the field; abstracts of a limited number of conference proceedings titles; and the Internet. REVIEW METHODS: A systematic review of studies including comparisons of TVT with any of the comparators was conducted. Alternative treatments considered were abdominal retropubic colposuspension (including both open and laparoscopic colposuspension), traditional suburethral sling procedures and injectable agents (periurethral bulking agents). The identified studies were critically appraised and their results summarised. A Markov model comparing TVT with the comparators was developed using the results of the review of effectiveness and data on resource use and costs from previously conducted studies. The Markov model was used to estimate costs and quality-adjusted life-years for up to 10 years following surgery and it incorporated a probabilistic analysis and also sensitivity analysis around key assumptions of the model. RESULTS: Based on limited data from direct comparisons with TVT and from systematic reviews, laparoscopic colposuspension and traditional slings have broadly similar cure rates to TVT and open colposuspension, whereas injectable agents appear to have lower cure rates. TVT is less invasive than colposuspension and traditional sling procedures, and is also usually performed under regional or local anaesthesia. The principal operative complication is bladder perforation. There are currently no randomised controlled trial (RCT) data beyond 2 years post-surgery, and long-term effects are therefore currently not known reliably. TVT was more likely to be considered cost-effective compared with the other surgical procedures. Increasing the absolute probability of cure following TVT reduced the likelihood that TVT would be considered cost-effective. CONCLUSIONS: The long-term performance of TVT in terms of both continence and unanticipated adverse effects is not known reliably at the moment. Despite relatively few robust comparative data, it appears that in the short to medium term TVT's effectiveness approaches that of alternative procedures currently available, and is of lower cost. As TVT is a less invasive procedure, it is possible that some women who would currently be managed non-surgically will be considered eligible for TVT. Increased adoption of TVT will require additional surgeons proficient in the technique. It is likely that some of the higher rates of complications, e.g. bladder perforation, reported for TVT are associated with a 'learning curve'. Appropriate training will therefore be needed for surgeons new to the operation, in respect of both the technical aspects of the procedure and the choice of women suitable for the operation. Further research suggestions include unbiased assessments of longer term performance from follow-up of controlled trials or population-based registries; more data from methodologically sound RCTs using standard outcome measures; a surveillance system to detect longer term complications, if any, associated with the use of tape; and rigorous evaluation before extending the use of TVT to women who are currently managed non-surgically.

Colposcopy↗
PubMed2002

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 livebirth rates per cycle varying between 13% and 28%, it's 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 livebirth compared with 1. expectant management 2. clomiphene citrate (CC) 3. intra uterine insemination (IUI) alone 4. IUI with controlled ovarian stimulation and 5. Gamete IntraFallopian Transfer (GIFT). SEARCH STRATEGY: RCTs were identified using the search strategies developed for the Menstrual Disorders and Subfertility Group. See Review group for more information. SELECTION CRITERIA: Only randomised controlled trials were included. Livebirth rate per woman was the primary outcome of interest. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed eligibility and quality of trials. MAIN RESULTS: Nine randomised controlled trials were identified. In two we could not extract data separately for unexplained infertility cases, two were non-randomised, one reported no valid rates (included in the review and 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 number of trials assessing the effectiveness of IVF with the other treatments were as follows: IVF versus expectant management (one), IVF versus IUI (one), IVF versus IUI with ovarian stimulation (two) and IVF versus GIFT (three). Livebirth rate per woman was reported in two 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 livebirth rates for expectant management or GIFT. There was no evidence of a difference in livebirth rates between IVF and IUI either without (OR 0.51, 95% CI 0.23 to 1.1) or with (OR 0.87, 95% CI 0.42 to 1.8) ovarian stimulation. There was no evidence of a difference in clinical pregnancy rates between IVF and expectant management. There was no significant difference in the clinical pregnancy rates between IVF and GIFT (OR 0.47, 95% CI 0.24 to 0.92). There was no evidence of a difference in the multiple pregnancy rates between IVF and either IUI with ovarian stimulation (OR 1.59, 95% CI 0.68 to 3.70) or GIFT (OR 0.47, 95% CI 0.08 to 0.58). 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. REVIEWER'S CONCLUSIONS: Any effect of IVF relative to expectant management, clomiphene citrate, IUI with or without ovarian stimulation and GIFT in terms of livebirth 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. Livebirth rates are seldom reported. 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 compared 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.

Female↗
PubMed2002

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

BACKGROUND: Although the benefits of recombinant human erythropoietin (rHu EPO) administration in dialysis patients have been demonstrated the optimal frequency regimen has not as yet been established. Treatment with rHu EPO is expensive, there is therefore a need for optimising the efficiency of its administration. OBJECTIVES: The objectives of this review were to assess the effects of different frequency regimens of rHu EPO administration in dialysis patients in terms of i) effectiveness (correction of anaemia, quality of life and freedom from adverse events) ii) efficiency (optimal resource use) of different rHu EPO dose regimen policies. SEARCH STRATEGY: We searched MEDLINE (1980 to May Week 3 2001), EMBASE (1984 to Week 24 2001), BIOSIS (1985 to January 1997), CINAHL (1982 to October 1997), The Cochrane Library (Issue 1, 1997), CHEMABS (1984 to November 1996), SIGLE (1980 to June 1996), CRIB (10th edition, 1995), UK NRR (14th consolidation, September 1996), RSC ( 1980 to February 1997), HealthSTAR (1995 to October 1997), IBSS (1984 to July 1997), NEED (July 1997) and reference lists of relevant articles. We contacted biomedical companies and investigators in the field and we hand searched Kidney International (including all supplements but excluding all conference proceedings except for 1994) July 1983 to May 1997 inclusive. The Internet was also searched on: August 1997. We had also identified some studies from a previous broad search for all randomised controlled trials (RCTs) relevant to the management of end-stage renal disease. Date of the most recent search: June 2001. SELECTION CRITERIA: All randomised or quasi randomised controlled trials comparing different frequencies of rHu EPO administration in dialysis patients. Subgroup analyses were performed comparing haemodialysis and CAPD patients and also subcutaneous and intravenous administration. DATA COLLECTION AND ANALYSIS: Only published data were used. Data were abstracted by a single investigator on to a standard form. The data abstracted were relevant to the predetermined outcome measures: measures of correction of anaemia, rHu EPO dose, quality of life measures, adverse events, number of withdrawals from study, mortality. Where appropriate, a summary relative risk (RR) was calculated for dichotomous data and a weighted mean difference (WMD) or standardised mean difference (SMD) for continuous data. MAIN RESULTS: Eight studies met our inclusion criteria. When once a week administration was compared with twice weekly there was no significant difference in the ability to maintain the target haemoglobin (RR 1.00, 95% CI 0.42 to 2.40). Mean haemoglobin after twelve weeks of therapy was not different between the two groups (WMD -0.21g/dl, 95% CI -0.98 to 0.56). No difference was found in mean haemoglobin or haematocrit at the end of any studies which compared once with thrice weekly administration of rHu EPO (SMD -0.31, 95% CI -0.67 to 0.06). A single study which compared once with more that thrice weekly administration showed no significant difference in mean haemoglobin at the end of the maintenance phase (mean difference -0.2g/dl, 95% CI -0.65 to 0.25). The dosage of erythropoietin required by those on haemodialysis receiving rHu EPO once weekly was just significantly more (WMD 12.0 U/kg, 95% CI 0.24 to 23.76) than those receiving it twice weekly but the confidence interval is wide. No such difference was found for CAPD patients nor when the results were combined (WMD 5.15 U/kg, 95% CI -3.74 to 14.05). The result was not significant when comparing once weekly with thrice weekly administration (WMD 10.00 U/kg, 95% CI -80.87 to 100.87). There was no difference in the frequency of adverse events between any of the groups studies. REVIEWER'S CONCLUSIONS: There is no significant difference between once weekly versus thrice weekly subcutaneous administration of rHu EPO. Once weekly administration of rHu EPO would require an additional 12U/kg/week for patients on haemodialysis, however this is based on one very small study. The cost of this additional hRu EPO nee, however this is based on one very small study. The cost of this additional hRu EPO needs to assessed, in particular with regard to patient preference and compliance.

Anemia↗
PubMed2001

Double bag or Y-set versus standard transfer systems for continuous ambulatory peritoneal dialysis in end-stage renal disease.

BACKGROUND: Peritonitis is the most frequent serious complication of continuous ambulatory peritoneal dialysis (CAPD). It has a major influence on the number of patients switching from CAPD to haemodialysis and has probably restricted the wider acceptance and uptake of CAPD as an alternative mode of dialysis. OBJECTIVES: This systematic review sought to determine if modifications of the transfer set (Y-set or double bag systems) used in CAPD exchanges are associated with a reduction in peritonitis and an improvement in other relevant outcomes. SEARCH STRATEGY: A broad search strategy was employed which attempted to identify all RCTs or quasi-RCTs relevant to the management of end-stage renal disease (ESRD). Five electronic databases were searched (Medline 1966-1999, EMBASE 1984-1999, CINAHL 1982-1996, BIOSIS 1985-1996 and the Cochrane Library), authors of included studies and relevant biomedical companies were contacted, reference lists of identified RCTs and relevant narrative reviews were screened and Kidney International 1980-1997 was hand searched. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials comparing double bag, Y-set and standard CAPD exchange systems in patients with ESRD. DATA COLLECTION AND ANALYSIS: Data were abstracted by a single investigator onto a standard form and subsequently entered into Review Manager 4.0.4. Odds Ratio (OR) for dichotomous data and a (Weighted) Mean Difference (WMD) for continuous data were calculated with 95% confidence intervals (95% CI). MAIN RESULTS: Twelve eligible trials with a total of 991 randomised patients were identified. In trials comparing either the Y-set or double bag systems with the standard systems significantly fewer patients (OR 0.33, 95% CI 0.24 to 0.46) experienced peritonitis and the number of patient-months on CAPD per episode of peritonitis were consistently greater. When the double bag systems were compared with the Y-set systems significantly fewer patients experienced peritonitis (OR 0.44, 95% CI 0.27 to 0.71) and the numbers of patient-months on CAPD/ episode of peritonitis were also greater. REVIEWER'S CONCLUSIONS: Double bag systems should be the preferred exchange systems in CAPD.

Humans↗
PubMed2001

Comparison of 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 can be used including 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 (1966 to December 2000), Embase (1981 to November 2000), PreMedline (29 November 2000), HealthStar (1975 to December 2000), Cinahl (1982 to October 2000), The Cochrane Controlled Trials Register (Issue 1, 1996), Biosis (1989 to June 1995), Sigle (1980 to June 1996), Crib (10th edition, 1995), UK National Research Register (September 1996), and reference lists of relevant articles. We contacted biomedical companies, investigators and we hand searched Kidney International (1980 to 1997). Date of the most recent searches: November 2000. SELECTION CRITERIA: All randomised or quasi-randomised clinical trials 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 from included studies onto a standard form by one reviewer and checked by another. MAIN RESULTS: Twenty seven studies met our inclusion criteria and where possible data from these were summated by meta-analyses (Peto's odds ratio (OR) and weighted mean difference (WMD) with 95% confidence intervals (CI)). Twenty two outcome measures were sought in 10 broad areas. For two (number of episodes of significant infection per year and quality of life) no data were available. For the comparison of cellulose with synthetic membranes, data for 12/20 outcome measures were available in only a single trial. For modified cellulose and synthetic membranes, data for three outcome measures were available in one trial only and for 12 of the outcomes no data were found, crossover studies were analysed separately and studies which randomised by patient yet analysed by dialysis sessions adjusted for clustering. Pre-dialysis beta2 microglobulin concentrations were significantly lower at the end of the studies in patients treated with synthetic membranes (WMD - 14.5; 95% CI -17.4 to -11.6). One crossover study showed a lowering of beta2 microglobulin when low flux synthetic membranes were used. When analysed for a change in beta2 microglobulin across a trial a fall was only noted when high flux membranes were used. In one very small study the incidence of amyloid was less in patients who were dialysed for six years with high flux synthetic membranes (OR 0.05; 95% CI 0.01 to 0.18). In the single study which measured triglyceride values there was a significant difference in favour of the synthetic (high flux) membrane (WMD -0.66; 95% CI -1.18 to -0.14). Serum albumin was higher in patients treated with synthetic membranes (both low and high flux) although this just bordered statistical significance (WMD -0.09; 95% CI -0.18 to 0.00). Dialysis adequacy measured by Kt/V was marginally higher when cellulose membranes were used (WMD 0.10; 95% CI 0.04 to 0.16). There was no significant difference between these membranes for any of the other clinical outcomes measures but confidence intervals were generally wide. No differences were found between modified cellulose and synthetic membranes although many fewer trials were carried out for this comparison. REVIEWER'S CONCLUSIONS: For clinical practice This systematic literature review has generated no evidence of benefit when synthetic membranes were used compared with cellulose/modified cellulose membranes in terms of reduced mortality nor 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. End-of-study beta2 microglobulin values, and possibly the development of amyloid disease, were less in patients treated with synthetic membranes compared with cellulose membranes. Plasma triglyceride values were also lower with synthetic membranes in the single study that measured this outcome. Differences in these outcomes may have reflected the high flux of the synthetic membrane. Serum albumin was higher when synthetic membranes of both high and low flux were used. Kt/V and urea reduction ratio were higher when cellulose or modified cellulose membranes were used in the few studies that measured these outcomes. We are hesitant to recommend the universal use of synthetic membranes for haemodialysis in patients with ESRD because of; the small number of trials (particularly for modified cellulose membranes, most with low patient numbers), the heterogeneity of many of the trials compared, the variations in membrane flux, the differences in exclusion criteria, particularly relating to comorbidity and the relative lack of patient-centred outcomes studied. Such evidence as we have favours synthetic membranes but even if we assume extra benefit it may be at considerable cost, particularly if high flux synthetic membranes were to be used. For further research A further systematic review of RCTs comparing high and low flux haemodialysis membranes, subgrouped according to membrane composition (cellulose, modified cellulose, synthetic) and reporting clinical outcomes of major importance to patients needs to be undertaken. Further pragmatic RCTs are required to compare the different dialysis membranes available. We recommend that they: - Take into account other properties including flux as well as the material from which the membrane is made and test modified cellulose membranes as well as standard ones. - Record an agreed minimum dataset on primary outcomes of major importance to patients. - Explicitly record whether symptoms are patient- or staff-reported recognising that generally patient reporting will be more appropriate for evaluating effectiveness but staff reported data may be necessary for calculating the cost of treating complications. - Be multi-centre (and possibly multinational) to have sufficient patients to complete the study to allow for a considerable number of withdrawals and dropouts. - Have sufficient length of follow up to draw conclusions for important clinical outcome measures and continue to follow patients who have renal transplants. - Include older patients and those with comorbid illnesses and take into account age and comorbidity when assessing outcomes (possibly by stratification at trial entry). - Carry out, in parallel, an economic evaluation of the different policies being compared in the trial.

Cellulose↗
PubMed2001

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. There is a concern that rHu EPO may accelerate the deterioration in renal function, however the opposing view is that if rHu EPO is as effective in pre-dialysis patients that by improving the patients sense of well-being the onset of dialysis could be delayed. OBJECTIVES: To assess the effects of rHu EPO use in pre-dialysis patients with renal anaemia. SEARCH STRATEGY: We searched MEDLINE (1980 to May Week 3 2001), EMBASE (1984 to Week 24 2001), BIOSIS (1985 to January 1997), CINAHL (1982 to October 1997), The Cochrane Library (Issue 1, 1997), CHEMABS (1984 to November 1996), SIGLE (1980 to June 1996), CRIB (10th edition, 1995), UK NRR (14TH consolidation, September 1996), RSC ( 1980 to February 1997), HealthSTAR (1995 to October 1997), IBSS (1984 to July 1997), NEED (July 1997) and reference lists of relevant articles. We contacted biomedical companies and investigators in the field and we hand searched Kidney International (including all supplements but excluding all conference proceedings except for 1994) July 1983 to May 1997 inclusive. The internet was also searched on: August 1997. We had also identified some studies from a previous broad search for all randomised controlled trials (RCTs) relevant to the management of end-stage renal disease. Date of the most recent search: June 2001. SELECTION CRITERIA: RCTs or quasi-RCTs comparing the use of rHu EPO with no rHu EPO or placebo in pre-dialysis patients. DATA COLLECTION AND ANALYSIS: Only published data were used. Data were abstracted by a single investigator onto a standard form. A sample of the data abstracted was double-checked by another reviewer. The data abstracted were relevant to the predetermined outcome measures. Some authors were contacted to clarify how patients were allocated to groups. All authors from included studies were contacted for missing information. MAIN RESULTS: Twelve studies with a total of 232 participants met the inclusion criteria and where possible data from these were summated by meta-analyses (Peto's Odds Ratio (OR) and Weighted Mean Difference (WMD)). The majority of the trials included small numbers and were of short duration (8-10 weeks) with the exception of three trials. There was a marked improvement in haemoglobin (mean difference 2.3g/dL, 95% CI 1.37 to 3.23) and haematocrit (WMD 9.92%, 95% CI 8.78 to 11.05) with the treatment and a decrease in the number of patients requiring blood transfusion (OR 0.25, 95% CI 0.09 to 0.69). The data from all studies which reported quality of life or exercise capacity demonstrated an improvement in the rHu EPO group. None of the measures of progression of renal disease (when a summary statistic was calculated) demonstrated a statistically significant difference. Though the requirement for antihypertensive treatment appears to be increased by rHu EPO (OR 1.84, 95% CI 1.02 to 3.32), there was no other statistically significant increase in adverse events. Based on the limited current evidence, decisions therefore have to be made on whether the putative benefits in terms of quality of life identified in the review are worth the extra costs of pre-dialysis rHu EPO. REVIEWER'S CONCLUSIONS: This review has shown that treatment with rHu EPO in pre-dialysis patients corrects anaemia and avoids the requirement for blood transfusions. There are also improvements in quality of life and exercise capacity. There may be increased hypertension. Most of the trials were not of sufficient duration to assess the effects of rHu EPO on progression of renal disease. In the long term, questions still remain about whether pre-dialysis rHu EPO either speeds up or delays the onset of dialysis. Thus there is insufficient evidence on the total costs and benefits of treating pre-dialysis patients with rHu EPO.

Anemia↗
PubMed2001

Dialysis for end-stage renal disease. Determining a cost-effective approach.

OBJECTIVE: Renal replacement therapy (RRT) is essential for maintenance of life for those with end-stage renal disease. However, there remain many areas of uncertainty about which method of RRT should be chosen. This paper reports an economic model based on a systematic review that attempts to determine which method of dialysis, continuous ambulatory peritoneal dialysis (CAPD) or hemodialysis, a patient should have as the initial method of RRT. METHODS: A systematic review and a costing exercise carried out in a Scottish hospital were used to populate a Markov model. Scenario analysis was used to model plausible variations in variables included in the model. RESULTS: In 8 of the 16 scenarios developed hemodialysis dominated CAPD. In a further eight scenarios, the cost per life-year displayed considerable variability, ranging from between 5,000 Pounds to 51,000 Pounds. The higher costs per life-year were associated with minimum estimates of additional survival for a patient starting RRT on hospital hemodialysis. CONCLUSION: It may be more cost-effective to manage patients starting on RRT with hospital hemodialysis than CAPD. This has particular implications for the United Kingdom, given that up to 50% of new patients receive CAPD.

Cost-Benefit Analysis↗
PubMed2001

Programme approach to managing informed commissioning.

The objective of this paper is to examine possible organizational reasons for why UK NHS commissioners have not adopted programme budgeting and marginal analysis (PBMA). This is despite increasing evidence of discontent with current commissioning and priority-setting processes, increasing research evidence demonstrating the potential of PBMA and support for the principles of PBMA. Two separate semistructured surveys of the views of commissioning decision-makers on the use of PBMA were carried out at Grampian Health Board and Newcastle & North Tyneside Health Authority. Twenty-nine decision-makers were interviewed. Both surveys found common barriers to implementation of PBMA, described by respondents as 'institutional inertia'. These were the reactive rather than proactive environment; the fear of 'unnecessary' explicitness; an aversion to unilateral innovation in the current NHS environment; and the demand for concrete evaluation evidence. It is concluded that these qualitative surveys have small samples and cannot claim to be representative. It may be significant that many issues were common to both surveys carried out separately in organizations. It is unlikely that NHS commissioning will independently adopt techniques such as PBMA, given the current commissioning environment and organizational structures. Implementation strategies and future research on such commissioning innovations may need to focus on institutions as well as the interventions.

Budgets↗
PubMed2000

Evidence-based medicine and health economics: a case study of end stage renal disease.

This paper explores the potential for use of an economic evaluation framework alongside systematic reviews. Clinical issues in dialysis therapy for end stage renal disease are used as case studies. The effectiveness data required were obtained from a systematic review of randomized controlled trials. Resource use and cost data were obtained from three sources; the identified randomized controlled trials, a separate review of observational studies and primary data collection. The results of the case studies show that, although simple economic evaluations were possible, issues arose, such as how transferable results are between settings and how appropriate it is to focus on the average patient. The interface between economic evaluation and systematic reviews needs to be further developed in order to ensure that the best available evidence can be used to inform future policy and research.

Chi-Square Distribution↗
PubMed2000

Evidence-based medicine in nephrology: identifying and critically appraising the literature.

BACKGROUND: Uncertainties about best management of end-stage renal disease (ESRD) are reflected in wide variations in practice. Systematic reviews aim to reduce uncertainty by strengthening the evidence base for clinical practice, allowing estimation of the benefits and risks of particular interventions, whilst minimizing the potential for bias. This paper describes the methods and conduct of six systematic reviews of aspects of the management of ESRD, and the yield in terms of trials found. METHODS: Our methodology was based on that recommended by the Cochrane Collaboration (an international initiative set up to perform and disseminate systematic reviews of health care). It involved a systematic search of electronic databases and bibliographic reference lists, together with handsearching of Kidney International for studies relevant to the management of ESRD, followed by a systematic assessment of study quality. RESULTS: Around 12,000 abstracts were assessed which had been identified from electronic sources. Of these, 2085 (18%) were deemed to be reports of possible randomized or quasi-randomized controlled trials relevant to the management of ESRD. Three hundred and forty were relevant to the six specific reviews, and after assessment of the full manuscripts, 39 studies were finally included in our reviews. Reports of a further nine trials, which were identified from other sources, were also included. The broad search adopted allowed the parallel development of a register of trials of all aspects of the management of ESRD. CONCLUSIONS: This study has demonstrated that the methodology of systematic reviews, as promoted by the Cochrane Renal Group, is feasible but has significant resource implications. The development of a register of randomized controlled trials (RCTs) related to the management of ESRD will facilitate this form of research in the future.

Databases as Topic↗
PubMed1998

A randomised comparison of strategies for reducing infective complications of induced abortion.

OBJECTIVES: To determine lower genital tract carriage rates of C. trachomatis, N. gonorrhoeae and bacterial vaginosis among women seeking termination of pregnancy. To compare two clinical management strategies for minimising the risks of infective morbidity after induced abortion. DESIGN: Prevalence of infections was assessed by screening women undergoing abortion. Clinical management strategies were compared by a randomised trial. SETTING: The gynaecology departments of four hospitals in Scotland. PARTICIPANTS: 1672 women undergoing induced abortion. INTERVENTIONS: Women randomised to prophylaxis received metronidazole 1 g rectally before abortion plus doxycycline 100 mg twice daily for seven days. Women randomised to screen-and-treat received appropriate antibiotics only if screening proved positive for one or more infection. MAIN OUTCOME MEASURES: Prevalences of infections; morbidity in the eight weeks following abortion as assessed by reported symptoms, general practitioner consultation and prescription rates and hospital re-attendances; costs to the NHS of alternative managements. RESULTS: Prevalence rates: C. trachomatis 5.6%; N gonorrhoeae 0.19%; bacterial vaginosis 17.5%. Overall, women allocated to receive prophylaxis had lower rates of measures of short term infective morbidity than those allocated to screen-and-treat. These differences only reached statistical significance for women who were reported negative on screening. The direct costs to the NHS of prophylaxis and screen-and-treat were calculated to be 8.17 and 18.34 per woman, respectively. CONCLUSIONS: Prevalences of lower genital tract infections which have been implicated in increased rates of infective morbidity after abortion are similar to those reported elsewhere. Universal antibiotic prophylaxis is at least as effective as a policy of screen-and-treat in minimising the risk of short term infective morbidity and is far more cost efficient.

Abortion, Induced↗
PubMed1998

Increased general practice workload due to a primary care led National Health Service: the need for evidence to support rhetoric.

Recent policy initiatives have focused on shifts in the balance of care from secondary care to primary care. A consequence of such shifts is increased workload in primary care. The aim of this paper is to appraise the literature critically to assess whether changes in the balance of care have led to additional work for general practices. In particular, the implications of this literature for the measurement of workload in general practice are highlighted. After an extensive, systematic literature search, only 12 studies that met the review criteria were identified. Although the studies pointed to negligible effects on the number of general practitioner (GP) visits, they failed to capture the many other attributes of a practice's work that are likely to be influenced by a shift in the balance of care. These include both qualitative (e.g. stress and mental effort) and quantitative (i.e. the use of resources in the practice, such as GPs, nurses and other staff's time and administration) measures of workload. The studies may therefore have under-estimated the effect on practice workload. To identify correctly the impact on workload of shifts in the balance of care, studies evaluating shifts need to improve their measurement of general practice workload. Furthermore, an extended definition of workload needs to be developed and tested, and workload monitored over time.

Family Practice↗
PubMed1997

An economic evaluation of thrombolysis in a remote rural community.

OBJECTIVES: To assess the cost effectiveness of community thrombolysis relative to hospital thrombolysis by investigating the extra costs and benefits of a policy of community thrombolysis, then establishing the extra cost per life saved by community thrombolysis. DESIGN: Economic evaluation based on the results of the Grampian region early anistreplase trial. SETTING: 29 rural general practices and one secondary care provider in Grampian, Scotland. SUBJECTS: 311 patients recruited to the Grampian region early anistreplase trial. INTERVENTIONS: Intravenous anistreplase given either by general practitioners or secondary care clinicians. MAIN OUTCOME MEASURES: Survival at 4 years and costs of administration of thrombolysis. RESULTS: Relative to hospital thrombolysis, community thrombolysis gives an additional probability of survival at 4 years of 11% (95% confidence interval 1% to 22%) at an additional cost of 425 pounds per patient. This gives a marginal cost of life saved at 4 years of 3,890 pounds (1,990 pounds to 42,820 pounds). CONCLUSIONS: The cost per life saved by community thrombolysis is modest compared with, for example, the cost of changing the thrombolytic drug used in hospital from streptokinase to alteplase.

Anistreplase↗