Transvaginal mesh or grafts or native tissue repair for vaginal prolapse.

BACKGROUND: Pelvic organ prolapse is the descent of one or more of the pelvic organs (uterus, vaginal apex, bladder, or bowel) into the vagina. In recent years, surgeons have increasingly used grafts in transvaginal repairs. Graft material can be synthetic or biological. The aim is to reduce prolapse recurrence and surpass the effectiveness of traditional native tissue repair (colporrhaphy) for vaginal prolapse. This is a review update; the previous version was published in 2016. OBJECTIVES: To determine the safety and effectiveness of transvaginal mesh or biological grafts compared to native tissue repair or other grafts in the surgical treatment of vaginal prolapse. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and two clinical trials registers (March 2022). SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing different types of vaginal repair (mesh, biological graft, or native tissue). DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, assessed risk of bias, and extracted data. The primary outcomes were awareness of prolapse, repeat surgery, and recurrent prolapse on examination. MAIN RESULTS: We included 51 RCTs (7846 women). The certainty of the evidence was largely moderate (ranging from very low to moderate). Transvaginal permanent mesh versus native tissue repair Awareness of prolapse at six months to seven years was less likely after mesh repair (risk ratio (RR) 0.83, 95% confidence interval (CI) 0.73 to 0.95; I2 = 34%; 17 studies, 2932 women; moderate-certainty evidence). This suggests that if 23% of women are aware of prolapse after native tissue repair, between 17% and 22% will be aware of prolapse after permanent mesh repair. Rates of repeat surgery for prolapse were lower in the mesh group (RR 0.71, 95% CI 0.53 to 0.95; I2 = 35%; 17 studies, 2485 women; moderate-certainty evidence). There was no evidence of a difference between the groups in rates of repeat surgery for incontinence (RR 1.03, 95% CI 0.67 to 1.59; I2 = 0%; 13 studies, 2206 women; moderate-certainty evidence). However, more women in the mesh group required repeat surgery for the combined outcome of prolapse, stress incontinence, or mesh exposure (RR 1.56, 95% CI 1.07 to 2.26; I2 = 54%; 27 studies, 3916 women; low-certainty evidence). This suggests that if 7.1% of women require repeat surgery after native tissue repair, between 7.6% and 16% will require repeat surgery after permanent mesh repair. The rate of mesh exposure was 11.8% and surgery for mesh exposure was 6.1% in women who had mesh repairs. Recurrent prolapse on examination was less likely after mesh repair (RR 0.42, 95% CI 0.32 to 0.55; I2 = 84%; 25 studies, 3680 women; very low-certainty evidence). Permanent transvaginal mesh was associated with higher rates of de novo stress incontinence (RR 1.50, 95% CI 1.19 to 1.88; I2 = 0%; 17 studies, 2001 women; moderate-certainty evidence) and bladder injury (RR 3.67, 95% CI 1.63 to 8.28; I2 = 0%; 14 studies, 1997 women; moderate-certainty evidence). There was no evidence of a difference between the groups in rates of de novo dyspareunia (RR 1.22, 95% CI 0.83 to 1.79; I2 = 27%; 16 studies, 1308 women; moderate-certainty evidence). There was no evidence of a difference in quality of life outcomes; however, there was substantial heterogeneity in the data. Transvaginal absorbable mesh versus native tissue repair There was no evidence of a difference between the two methods of repair at two years for the rate of awareness of prolapse (RR 1.05, 95% CI 0.77 to 1.44; 1 study, 54 women), rate of repeat surgery for prolapse (RR 0.47, 95% CI 0.09 to 2.40; 1 study, 66 women), or recurrent prolapse on examination (RR 0.53, 95% CI 0.10 to 2.70; 1 study, 66 women). The effect of either form of repair was uncertain for bladder-related outcomes, dyspareunia, and quality of life. Transvaginal biological graft versus native tissue repair There was no evidence of a difference between the groups at one to three years for the outcome awareness of prolapse (RR 1.06, 95% CI 0.73 to 1.56; I2 = 0%; 8 studies, 1374 women; moderate-certainty evidence), repeat surgery for prolapse (RR 1.15, 95% CI 0.75 to 1.77; I2 = 0%; 6 studies, 899 women; moderate-certainty evidence), and recurrent prolapse on examination (RR 0.96, 95% CI 0.71 to 1.29; I2 = 53%; 9 studies, 1278 women; low-certainty evidence). There was no evidence of a difference between the groups for dyspareunia or quality of life. Transvaginal permanent mesh versus any other permanent mesh or biological graft vaginal repair Sparse reporting of primary outcomes in both comparisons significantly limited any meaningful analysis. AUTHORS' CONCLUSIONS: While transvaginal permanent mesh is associated with lower rates of awareness of prolapse, repeat surgery for prolapse, and prolapse on examination than native tissue repair, it is also associated with higher rates of total repeat surgery (for prolapse, stress urinary incontinence, or mesh exposure), bladder injury, and de novo stress urinary incontinence. While the direction of effects and effect sizes are relatively unchanged from the 2016 version of this review, the certainty and precision of the findings have all improved with a larger sample size. In addition, the clinical relevance of these data has improved, with 10 trials reporting 3- to 10-year outcomes. The risk-benefit profile means that transvaginal mesh has limited utility in primary surgery. Data on the management of recurrent prolapse are of limited quality. Given the risk-benefit profile, we recommend that any use of permanent transvaginal mesh should be conducted under the oversight of the local ethics committee in compliance with local regulatory recommendations. Data are not supportive of absorbable meshes or biological grafts for the management of transvaginal prolapse.

Investigation of text-mining methodologies to aid the construction of search strategies in systematic reviews of diagnostic test accuracy-a case study.

Current methodologies for designing search strategies rely heavily on the knowledge and expertise of information specialists. Yet, the volume and complexity of scientific literature is overwhelming for even the most experienced information specialists, making it difficult to produce robust search strategies for complex systematic reviews. In this case study, we aimed to assess and describe the benefits and limitations of using semi-automated text-mining tools for designing search strategies in a systematic review of diagnostic test accuracy. An experienced information specialist designed a search strategy using traditional methods. This strategy was then amended to include additional terms identified by text-mining tools. We evaluated the usability and expertise required, risk of introducing bias to the search, precision of the search strategy and rated the usefulness of the tools. Thirteen of the 16 investigated tools produced a total of 40 additional terms, beyond those in the original search strategy. This resulted in 11 previously unidentified relevant articles being retrieved. Precision was reduced or remained the same in all cases. After considering all aspects of the investigation we rated each application, with two being 'extremely useful', three being 'useful', three having 'no impact' and eight being 'not very useful'. Comparative analysis revealed discrepancies between similar tools. Our findings have implications for the way in which these methodologies are used and applied to search strategies. If semi-automated techniques are to become mainstream in information retrieval for complex systematic reviews, we need tailored tools that fit information specialists' requirements across disciplines.

A rapid priority setting exercise combining existing, emergent evidence with stakeholder knowledge identified broad topic uncertainties.

OBJECTIVES: The project aimed to rapidly identify priority topic uncertainties as a first step to identify future systematic review questions of pertinence to key international fecal incontinence (FI) stakeholders (patients, carers, health care professionals, policy makers and voluntary, community, or social enterprise representatives). The paper's aim is to share our methods, experience, and learning with other groups planning to deliver a rapid priority setting exercise. STUDY DESIGN AND SETTING: An evidence gap map incorporated three evidence streams: emerging evidence identified through horizon scanning; existing evidence identified through systematic searches of bibliographic databases; and FI stakeholder insights collected through an international survey. The evidence gap map was presented during an online workshop with stakeholders, where they shared their expertize to expand, refine, and rank topic uncertainties using ideation techniques, focus group discussions, consensus techniques, and online polling. RESULTS: The multistep methods used to deliver this priority setting exercise resulted in identification of broad priority topic uncertainties. The methods appear to have high acceptability and engagement with participants but await full evaluation. CONCLUSION: This project successfully followed robust methodology, building upon frameworks from published priority setting and evidence gap mapping projects while incorporating strong patient and public involvement components.

Rapid priority setting exercise on faecal incontinence for Cochrane Incontinence.

OBJECTIVE: This rapid priority setting exercise aimed to identify, expand, prioritise and explore stakeholder (patients, carers and healthcare practitioners) topic uncertainties on faecal incontinence (FI). DESIGN: An evidence gap map (EGM) was produced to give a visual overview of emerging trial evidence; existing systematic review-level evidence and FI stakeholder topic uncertainties derived from a survey. This EGM was used in a knowledge exchange workshop that promoted group discussions leading to the prioritisation and exploration of FI stakeholder identified topic uncertainties. RESULTS: Overall, a mismatch between the existing and emerging evidence and key FI stakeholder topic uncertainties was found. The prioritised topic uncertainties identified in the workshop were as follows: psychological support; lifestyle interventions; long-term effects of living with FI; education; constipation and the cultural impact of FI. When these six prioritised topic uncertainties were explored in more depth, the following themes were identified: education; impact and burden of living with FI; psychological support; healthcare service improvements and inconsistencies; the stigma of FI; treatments and management; culturally appropriate management and technology and its accessibility. CONCLUSIONS: Topic uncertainties identified were broad and wide ranging even after prioritisation. More research is required to unpick the themes emerging from the in-depth discussion and explore these further to achieve a consensus on deliverable research questions.

Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis.

BACKGROUND: Bladder pain syndrome (BPS), which includes the condition of interstitial cystitis, is a poorly understood clinical condition for which patients present with varying symptoms. Management of BPS is challenging for both patients and practitioners. At present, there is no universally accepted diagnosis and diverse causes have been proposed. This is reflected in wide-ranging treatment options, used alone or in combination, with limited evidence. A network meta-analysis (NMA) simultaneously comparing multiple treatments may help to determine the best treatment options for patients with BPS. OBJECTIVES: To conduct a network meta-analysis to assess the effects of interventions for treating people with symptoms of bladder pain syndrome (BPS). SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL, in the Cochrane Library), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and handsearched journals and conference proceedings (searched 11 May 2018) and the reference lists of relevant articles. We conducted a further search on 5 June 2019, which yielded four small studies that were screened for eligibility but were not incorporated into the review. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs of interventions for treating adults with BPS. All types of interventions (including conservative, pharmacological and surgical) were eligible. DATA COLLECTION AND ANALYSIS: We assessed the risk of bias of included studies using Cochrane's 'Risk of bias' tool. Primary outcomes were the number of people cured or improved, pain, frequency and nocturia. For each outcome, random-effects NMA models were fitted using WinBUGS 1.4. We monitored median odds ratios (ORs) for binary outcomes and mean differences (MDs) for continuous outcomes with 95% credible intervals (Crls). We compared results of the NMA with direct evidence from pairwise meta-analysis of head-to-head trials. We used the CINeMA tool to assess the certainty of evidence for selected treatment categories. MAIN RESULTS: We included 81 RCTs involving 4674 people with a median of 38 participants (range 10 to 369) per RCT. Most trials compared treatment against control; few trials compared two active treatments. There were 65 different active treatments, and some comparisons were informed by direct evidence from only one trial. To simplify, treatments were grouped into 31 treatment categories by mode of action. Most studies were judged to have unclear or high risk of bias for most domains, particularly for selection and detection bias. Overall, the NMA suggested that six (proportion cured/improved), one (pain), one (frequency) and zero (nocturia) treatment categories were effective compared with control, but there was great uncertainty around estimates of effect. Due to the large number of intervention comparisons in this review, we focus on three interventions: antidepressants, pentosan polysulfate (PPS) and neuromuscular blockade. We selected these interventions on the basis that they are given 'strong recommendations' in the EAU Guidelines for management of BPS (EAU Guidelines 2019). We found very low-certainty evidence suggesting that antidepressants were associated with greater likelihood of cure or improvement compared with control (OR 5.91, 95% CrI 1.12 to 37.56), but it was uncertain whether they reduced pain (MD -1.27, 95% CrI -3.25 to 0.71; low-certainty evidence), daytime frequency (MD -2.41, 95% CrI -6.85 to 2.05; very low-certainty evidence) or nocturia (MD 0.01, 95% CrI -2.53 to 2.50; very low-certainty evidence). There was no evidence that PPS had improved cure/improvement rates (OR 0.14, 95% CrI 0.40 to 3.35; very low-certainty evidence) or reduced pain (MD 0.42, 95% CrI -1.04 to 1.91; low-certainty evidence), frequency (MD -0.37, 95% CrI -5.00 to 3.44; very low-certainty evidence) or nocturia (MD -1.20, 95% CrI -3.62 to 1.28; very low-certainty evidence). There was evidence that neuromuscular blockade resulted in greater cure or improvement (OR 5.80, 95% CrI 2.08 to 18.30) but no evidence that it improved pain (MD -0.33, 95% CrI -1.71 to 1.03), frequency (MD -0.91, 95% CrI -3.24, 1.29) or nocturia (MD -0.04, 95% CrI -1.35 to 1.27). The certainty of this evidence was always very low. AUTHORS' CONCLUSIONS: We are uncertain whether some treatments may be effective in treating patients with BPS because the certainty of evidence was generally low or very low. Data were available for a relatively large number of trials, but most had small sample sizes and effects of treatments often could not be estimated with precision. An NMA was successfully conducted, but limited numbers of small trials for each treatment category hampered our ability to fully exploit the advantages of this analysis. Larger, more focused trials are needed to improve the current evidence base.

Surgical interventions for women with stress urinary incontinence: systematic review and network meta-analysis of randomised controlled trials.

OBJECTIVES: To compare the effectiveness and safety of surgical interventions for women with stress urinary incontinence. DESIGN: Systematic review and network meta-analysis. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials evaluating surgical interventions for the treatment of stress urinary incontinence in women. METHODS: Identification of relevant randomised controlled trials from Cochrane reviews and the Cochrane Incontinence Specialised Register (searched May 2017), which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Medline In-Process, Medline Epub Ahead of Print, CINAHL, ClinicalTrials.gov, and WHO ICTRP. The reference lists of relevant articles were also searched. Primary outcomes were "cure" and "improvement" at 12 months, analysed by means of network meta-analyses, with results presented as the surface under the cumulative ranking curve (SUCRA). Adverse events were analysed using pairwise meta-analyses. Risk of bias was assessed using the Cochrane risk of bias tool. The quality of evidence for network meta-analysis was assessed using the GRADE approach. RESULTS: 175 randomised controlled trials assessing a total of 21 598 women were included. Most studies had high or unclear risk across all risk of bias domains. Network meta-analyses were based on data from 105 trials that reported cure and 120 trials that reported improvement of incontinence symptoms. Results showed that the interventions with highest cure rates were traditional sling, retropubic midurethral sling (MUS), open colposuspension, and transobturator MUS, with rankings of 89.4%, 89.1%, 76.7%, and 64.1%, respectively. Compared with retropubic MUS, the odds ratio of cure for traditional sling was 1.06 (95% credible interval 0.62 to 1.85), for open colposuspension was 0.85 (0.54 to 1.33), and for transobtrurator MUS was 0.74 (0.59 to 0.92). Women were also more likely to experience an improvement in their incontinence symptoms after receiving retropubic MUS or transobturator MUS compared with other surgical procedures. In particular, compared with retropubic MUS, the odds ratio of improvement for transobturator MUS was 0.76 (95% credible interval 0.59 to 0.98), for traditional sling was 0.69 (0.39 to 1.26), and for open colposuspension was 0.65 (0.41 to 1.02). Quality of evidence was moderate for retropubic MUS versus transobturator MUS and low or very low for retropubic MUS versus the other two interventions. Data on adverse events were available mainly for mesh procedures, indicating a higher rate of repeat surgery and groin pain but a lower rate of suprapubic pain, vascular complications, bladder or urethral perforation, and voiding difficulties after transobturator MUS compared with retropubic MUS. Data on adverse events for non-MUS procedures were sparse and showed wide confidence intervals. Long term data were limited. CONCLUSIONS: Retropubic MUS, transobturator MUS, traditional sling, and open colposuspension are more effective than other procedures for stress urinary incontinence in the short to medium term. Data on long term effectiveness and adverse events are, however, limited, especially around the comparative adverse events profiles of MUS and non-MUS procedures. A better understanding of complications after surgery for stress urinary incontinence is imperative. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016049339.

Transurethral radiofrequency collagen denaturation for the treatment of women with urinary incontinence.

BACKGROUND: Transurethral radiofrequency collagen denaturation is a relatively novel, minimally invasive device-based intervention used to treat individuals with urinary incontinence (UI). No systematic review of the evidence supporting its use has been published to date. OBJECTIVES: To evaluate the efficacy of transurethral radiofrequency collagen denaturation, compared with other interventions, in the treatment of women with UI.Review authors sought to compare the following.• Transurethral radiofrequency collagen denaturation versus no treatment/sham treatment.• Transurethral radiofrequency collagen denaturation versus conservative physical treatment.• Transurethral radiofrequency collagen denaturation versus mechanical devices (pessaries for UI).• Transurethral radiofrequency collagen denaturation versus drug treatment.• Transurethral radiofrequency collagen denaturation versus injectable treatment for UI.• Transurethral radiofrequency collagen denaturation versus other surgery for UI. SEARCH METHODS: We conducted a systematic search of the Cochrane Incontinence Group Specialised Register (searched 19 December 2014), EMBASE and EMBASE Classic (January 1947 to 2014 Week 50), Google Scholar and three trials registries in December 2014, along with reference checking. We sought to identify unpublished studies by handsearching abstracts of major gynaecology and urology meetings, and by contacting experts in the field and the device manufacturer. SELECTION CRITERIA: Randomised and quasi-randomised trials of transurethral radiofrequency collagen denaturation versus no treatment/sham treatment, conservative physical treatment, mechanical devices, drug treatment, injectable treatment for UI or other surgery for UI in women were eligible. DATA COLLECTION AND ANALYSIS: We screened search results and selected eligible studies for inclusion. We assessed risk of bias and analysed dichotomous variables as risk ratios (RRs) with 95% confidence intervals (CIs) and continuous variables as mean differences (MDs) with 95% CIs. We rated the quality of evidence using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. MAIN RESULTS: We included in the analysis one small sham-controlled randomised trial of 173 women performed in the United States. Participants enrolled in this study had been diagnosed with stress UI and were randomly assigned to transurethral radiofrequency collagen denaturation (treatment) or a sham surgery using a non-functioning catheter (no treatment). Mean age of participants in the 12-month multi-centre trial was 50 years (range 22 to 76 years).Of three patient-important primary outcomes selected for this systematic review, the number of women reporting UI symptoms after intervention was not reported. No serious adverse events were reported for the transurethral radiofrequency collagen denaturation arm or the sham treatment arm during the 12-month trial. Owing to high risk of bias and imprecision, we downgraded the quality of evidence for this outcome to low. The effect of transurethral radiofrequency collagen denaturation on the number of women with an incontinence quality of life (I-QOL) score improvement ≥ 10 points at 12 months was as follows: RR 1.11, 95% CI 0.77 to 1.62; participants = 142, but the confidence interval was wide. For this outcome, the quality of evidence was also low as the result of high risk of bias and imprecision.We found no evidence on the number of women undergoing repeat continence surgery. The risk of other adverse events (pain/dysuria (RR 5.73, 95% CI 0.75 to 43.70; participants = 173); new detrusor overactivity (RR 1.36, 95% CI 0.63 to 2.93; participants = 173); and urinary tract infection (RR 0.95, 95% CI 0.24 to 3.86; participants = 173) could not be established reliably as the trial was small. Evidence was insufficient for assessment of whether use of transurethral radiofrequency collagen denaturation was associated with an increased rate of urinary retention, haematuria and hesitancy compared with sham treatment in 173 participants. The GRADE quality of evidence for all other adverse events with available evidence was low as the result of high risk of bias and imprecision.We found no evidence to inform comparisons of transurethral radiofrequency collagen denaturation with conservative physical treatment, mechanical devices, drug treatment, injectable treatment for UI or other surgery for UI. AUTHORS' CONCLUSIONS: It is not known whether transurethral radiofrequency collagen denaturation, as compared with sham treatment, improves patient-reported symptoms of UI. Evidence is insufficient to show whether the procedure improves disease-specific quality of life. Evidence is also insufficient to show whether the procedure causes serious adverse events or other adverse events in comparison with sham treatment, and no evidence was found for comparison with any other method of treatment for UI.

Double bag or Y-set versus standard transfer systems for continuous ambulatory peritoneal dialysis in end-stage kidney 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.This is an update of a review first published in 2000. 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 METHODS: We searched the Cochrane Renal Group's Specialised Register through contact with the Trials Search Co-ordinator. Studies contained in the Specialised Register are identified through search strategies specifically designed for CENTRAL, MEDLINE and EMBASE. Date of last search: 22 October 2013. SELECTION CRITERIA: Randomised controlled trials (RCTs) or quasi-RCTs comparing double bag, Y-set and standard peritoneal dialysis (PD) exchange systems in patients with end-stage kidney disease. DATA COLLECTION AND ANALYSIS: Data were abstracted by a single investigator onto a standard form and analysed by Review Manager. Analysis was by a random effects model and results were expressed as risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI). MAIN RESULTS: Twelve eligible trials with a total of 991 randomised patients were identified. Despite the large total number of patients, few trials covered the same interventions, small numbers of patients were enrolled in each trial and the methodological quality was suboptimal. Y-set and twin-bag systems were superior to conventional spike systems (7 trials, 485 patients, RR 0.64, 95% CI 0.53 to 0.77) in preventing peritonitis in PD. AUTHORS' CONCLUSIONS: Disconnect systems should be the preferred exchange systems in CAPD.

Comparison of hemodialysis, hemofiltration, and acetate-free biofiltration for ESRD: systematic review.

BACKGROUND: We performed a systematic review of randomized controlled trials (RCTs) comparing hemodialysis (HD), hemofiltration (HF), hemodiafiltration (HDF), and acetate-free biofiltration (AFB) in the treatment of patients with end-stage renal disease to assess their clinical effectiveness. METHODS: The Cochrane CENTRAL Registry, MEDLINE, EMBASE, CINAHL, the American College of Physicians Database, Database of Abstracts of Reviews of Effectiveness, and reference lists were searched for randomized trials of HF, HDF, and AFB compared with HD; HDF compared with AFB; and HF compared with HDF. Two reviewers extracted data for all-cause mortality; hypotension, headache, nausea, vomiting, and any other adverse symptoms; quality of life (QoL); hospitalization; dialysis adequacy; and end-of-treatment beta 2 -microglobulin levels. Analysis was by means of a random-effects model, and results are expressed as relative risk (RR) and weighted mean difference (WMD) with 95% confidence intervals (CIs). RESULTS: Eighteen eligible trials (588 patients) were identified. HDF was associated with significantly greater mortality risk than HD (4 trials, 326 patients; RR, 3.52; 95% CI, 1.37 to 9.47). Risk for mortality was not different among the other comparisons. Risks for hypotension episodes and dialysis-related symptoms were not significantly different with HD, HF, HDF, and AFB (18 trials, 583 patients). QoL, assessed by using an unvalidated scoring tool, appeared to be significantly improved in patients on HDF therapy than those on HD therapy (1 trial, 67 patients; WMD, 0.6; 95% CI, 0.3 to 0.9), but this was not evident when validated QoL assessment tools were used. Use of AFB compared with HDF was not associated with a significant difference in risk for hospitalization (1 trial, 11 patients; WMD, -0.45; 95% CI, -1.42 to 0.52). HDF in comparison to HD did not reduce the risk for carpal tunnel syndrome (1 trial, 67 patients; RR, 2.04; 95% CI, 0.59 to 7.00). Kt/V was significantly different with HDF compared with HD (3 trials, 124 patients; WMD, 0.14; 95% CI, 0.05 to 0.22). No other substantial data for these interventions and their impact on major patient-centered outcomes were available. CONCLUSION: The trials assessed were not powered adequately and had suboptimal method quality. It is not possible on the basis of effectiveness to prefer one extracorporeal renal replacement therapy modality to the other for end-stage kidney disease because significant differences in clinically important outcomes have not been shown by available published RCTs.

Assessing the learning curve effect in health technologies. Lessons from the nonclinical literature.

INTRODUCTION: Many health technologies exhibit some from of learning effect, and this represents a barrier to rigorous assessment. It has been shown that the statistical methods used are relatively crude. Methods to describe learning curves in fields outside medicine, for example, psychology and engineering, may be better. METHODS: To systematically search non-health technology assessment literature (for example, PsycLit and Econlit databases) to identify novel statistical techniques applied to learning curves. RESULTS: The search retrieved 9,431 abstracts for assessment, of which 18 used a statistical technique for analyzing learning effects that had not previously been identified in the clinical literature. The newly identified methods were combined with those previously used in health technology assessment, and categorized into four groups of increasing complexity: a) exploratory data analysis; b) simple data analysis; c) complex data analysis; and d) generic methods. All the complex structured data techniques for analyzing learning effects were identified in the nonclinical literature, and these emphasized the importance of estimating intra- and interindividual learning effects. CONCLUSION: A good dividend of more sophisticated methods was obtained by searching in nonclinical fields. These methods now require formal testing on health technology data sets.