Laparoscopic colposuspension for urinary incontinence in women.

BACKGROUND: Stress urinary incontinence (SUI) imposes significant health and economic burden on society and the women affected. Laparoscopic colposuspension was one of the first minimal access operations for the treatment of women with SUI, with the presumed advantages of avoiding major incisions, shorter hospital stays and quicker return to normal activities. OBJECTIVES: To determine the effects of laparoscopic colposuspension for urinary incontinence in women. SEARCH METHODS: We searched the Cochrane Incontinence Group Trials Register (searched 2 July 2009), and sought additional trials from other sources and by contacting study authors for unpublished data and trials. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials in women with symptomatic or urodynamic diagnosis of stress or mixed incontinence that included laparoscopic surgery as the intervention in at least one arm of the studies. DATA COLLECTION AND ANALYSIS: The review authors evaluated trials for methodological quality and their appropriateness for inclusion in the review. Two review authors extracted data and another cross checked them. Where appropriate, we calculated a summary statistic. MAIN RESULTS: We identified 22 eligible trials. Ten involved the comparison of laparoscopic with open colposuspension. Whilst the women's subjective impression of cure seemed similar for both procedures, in the short- and medium-term follow-up, there was some evidence of poorer results of laparoscopic colposuspension on objective outcomes. The results showed trends towards fewer perioperative complications, less postoperative pain and shorter hospital stay for laparoscopic compared with open colposuspension, however, laparoscopic colposuspension was more costly.Eight studies compared laparoscopic colposuspension with newer 'self-fixing' vaginal slings. There were no significant differences in the reported short- and long-term subjective cure rates of the two procedures but objective cure rates at 18 months favoured slings. We observed no significant differences for postoperative voiding dysfunction and perioperative complications. Laparoscopic colposuspension had a significantly longer operation time and hospital stay. We found significantly higher subjective and objective one-year cure rates for women randomised to two paravaginal sutures compared with one suture in a single trial. Three studies compared sutures with mesh and staples for laparoscopic colposuspension and showed a trend towards favouring the use of sutures. AUTHORS' CONCLUSIONS: Currently available evidence suggests that laparoscopic colposuspension may be as good as open colposuspension at two years post surgery. However, the newer vaginal sling procedures appear to offer even greater benefits, better objective outcomes in the short term and similar subjective outcomes in the longer term. If laparoscopic colposuspension is performed, the use of two paravaginal sutures appears to be the most effective method. The place of laparoscopic colposuspension in clinical practice should become clearer when there are more data available describing long-term results. A brief economic commentary (BEC) identified three studies suggesting that tension-free vaginal tape (TVT) may be more cost-effective compared with laparoscopic colposuspension but laparoscopic colposuspension may be slightly more cost-effective when compared with open colposuspension after 24 months follow-up.

Transcutaneous electrical nerve stimulation (TENS) for fibromyalgia in adults.

BACKGROUND: Fibromyalgia is characterised by persistent, widespread pain; sleep problems; and fatigue. Transcutaneous electrical nerve stimulation (TENS) is the delivery of pulsed electrical currents across the intact surface of the skin to stimulate peripheral nerves and is used extensively to manage painful conditions. TENS is inexpensive, safe, and can be self-administered. TENS reduces pain during movement in some people so it may be a useful adjunct to assist participation in exercise and activities of daily living. To date, there has been only one systematic review in 2012 which included TENS, amongst other treatments, for fibromyalgia, and the authors concluded that TENS was not effective. OBJECTIVES: To assess the analgesic efficacy and adverse events of TENS alone or added to usual care (including exercise) compared with placebo (sham) TENS; no treatment; exercise alone; or other treatment including medication, electroacupuncture, warmth therapy, or hydrotherapy for fibromyalgia in adults. SEARCH METHODS: We searched the following electronic databases up to 18 January 2017: CENTRAL (CRSO); MEDLINE (Ovid); Embase (Ovid); CINAHL (EBSCO); PsycINFO (Ovid); LILACS; PEDRO; Web of Science (ISI); AMED (Ovid); and SPORTDiscus (EBSCO). We also searched three trial registries. There were no language restrictions. SELECTION CRITERIA: We included randomised controlled trials (RCTs) or quasi-randomised trials of TENS treatment for pain associated with fibromyalgia in adults. We included cross-over and parallel-group trial designs. We included studies that evaluated TENS administered using non-invasive techniques at intensities that produced perceptible TENS sensations during stimulation at either the site of pain or over nerve bundles proximal (or near) to the site of pain. We included TENS administered as a sole treatment or TENS in combination with other treatments, and TENS given as a single treatment or as a course of treatments. DATA COLLECTION AND ANALYSIS: Two review authors independently determined study eligibility by assessing each record and reaching agreement by discussion. A third review author acted as arbiter. We did not anonymise the records of studies before assessment. Two review authors independently extracted data and assessed risk of bias of included studies before entering information into a 'Characteristics of included studies' table. Primary outcomes were participant-reported pain relief from baseline of 30% or greater or 50% or greater, and Patient Global Impression of Change (PGIC). We assessed the evidence using GRADE and added 'Summary of findings' tables. MAIN RESULTS: We included eight studies (seven RCTs, one quasi-RCT, 315 adults (299 women), aged 18 to 75 years): six used a parallel-group design and two used a cross-over design. Sample sizes of intervention arms were five to 43 participants.Two studies, one of which was a cross-over design, compared TENS with placebo TENS (82 participants), one study compared TENS with no treatment (43 participants), and four studies compared TENS with other treatments (medication (two studies, 74 participants), electroacupuncture (one study, 44 participants), superficial warmth (one cross-over study, 32 participants), and hydrotherapy (one study, 10 participants)). Two studies compared TENS plus exercise with exercise alone (98 participants, 49 per treatment arm). None of the studies measured participant-reported pain relief of 50% or greater or PGIC. Overall, the studies were at unclear or high risk of bias, and in particular all were at high risk of bias for sample size.Only one study (14 participants) measured the primary outcome participant-reported pain relief of 30% or greater. Thirty percent achieved 30% or greater reduction in pain with TENS and exercise compared with 13% with exercise alone. One study found 10/28 participants reported pain relief of 25% or greater with TENS compared with 10/24 participants using superficial warmth (42 °C). We judged that statistical pooling was not possible because there were insufficient data and outcomes were not homogeneous.There were no data for the primary outcomes participant-reported pain relief from baseline of 50% or greater and PGIC.There was a paucity of data for secondary outcomes. One pilot cross-over study of 43 participants found that the mean (95% confidence intervals (CI)) decrease in pain intensity on movement (100-mm visual analogue scale (VAS)) during one 30-minute treatment was 11.1 mm (95% CI 5.9 to 16.3) for TENS and 2.3 mm (95% CI 2.4 to 7.7) for placebo TENS. There were no significant differences between TENS and placebo for pain at rest. One parallel group study of 39 participants found that mean ± standard deviation (SD) pain intensity (100-mm VAS) decreased from 85 ± 20 mm at baseline to 43 ± 20 mm after one week of dual-site TENS; decreased from 85 ± 10 mm at baseline to 60 ± 10 mm after single-site TENS; and decreased from 82 ± 20 mm at baseline to 80 ± 20 mm after one week of placebo TENS. The authors of seven studies concluded that TENS relieved pain but the findings of single small studies are unlikely to be correct.One study found clinically important improvements in Fibromyalgia Impact Questionnaire (FIQ) subscales for work performance, fatigue, stiffness, anxiety, and depression for TENS with exercise compared with exercise alone. One study found no additional improvements in FIQ scores when TENS was added to the first three weeks of a 12-week supervised exercise programme.No serious adverse events were reported in any of the studies although there were reports of TENS causing minor discomfort in a total of 3 participants.The quality of evidence was very low. We downgraded the GRADE rating mostly due to a lack of data; therefore, we have little confidence in the effect estimates where available. AUTHORS' CONCLUSIONS: There was insufficient high-quality evidence to support or refute the use of TENS for fibromyalgia. We found a small number of inadequately powered studies with incomplete reporting of methodologies and treatment interventions.

Reiki for depression and anxiety.

BACKGROUND: Anxiety and depression affect many people. Treatments do not have complete success and often require people to take drugs for long periods of time. Many people look for other treatments that may help. One of those is Reiki, a 2500 year old treatment described as a vibrational or subtle energy therapy, and is most commonly facilitated by light touch on or above the body. There have been reports of Reiki alleviating anxiety and depression, but no specific systematic review. OBJECTIVES: To assess the effectiveness of Reiki for treating anxiety and depression in people aged 16 and over. SEARCH METHODS: Search of the Cochrane Register of Controlled Trials (CENTRAL - all years), the Cochrane Depression, Anxiety and Neurosis Review Group's Specialised Register (CCDANCTR - all years), EMBASE, (1974 to November 2014), MEDLINE (1950 to November 2014), PsycINFO (1967 to November 2014) and AMED (1985 to November 2014). Additional searches were carried out on the World Health Organization Trials Portal (ICTRP) together with ClinicalTrials.gov to identify any ongoing or unpublished studies. All searches were up to date as of 4 November 2014. SELECTION CRITERIA: Randomised trials in adults with anxiety or depression or both, with at least one arm treated with Reiki delivered by a trained Reiki practitioner. DATA COLLECTION AND ANALYSIS: The two authors independently decided on inclusion/exclusion of studies and extracted data. A prior analysis plan had been specified but was not needed as the data were too sparse. MAIN RESULTS: We found three studies for inclusion in the review. One recruited males with a biopsy-proven diagnosis of non-metastatic prostate cancer who were not receiving chemotherapy and had elected to receive external-beam radiation therapy; the second study recruited community-living participants who were aged 55 years and older; the third study recruited university students.These studies included subgroups with anxiety and depression as defined by symptom scores and provided data separately for those subgroups. As this included only 25 people with anxiety and 17 with depression and 20 more with either anxiety or depression, but which was not specified, the results could only be reported narratively. They show no evidence that Reiki is either beneficial or harmful in this population. The risk of bias for the included studies was generally rated as unclear or high for most domains, which reduces the certainty of the evidence. AUTHORS' CONCLUSIONS: There is insufficient evidence to say whether or not Reiki is useful for people over 16 years of age with anxiety or depression or both.

Continuous positive airway pressure (CPAP) during the postoperative period for prevention of postoperative morbidity and mortality following major abdominal surgery.

BACKGROUND: Major abdominal surgery can be associated with a number of serious complications that may impair patient recovery. In particular, postoperative pulmonary complications (PPCs), including respiratory complications such as atelectasis and pneumonia, are a major contributor to postoperative morbidity and may even contribute to increased mortality. Continuous positive airway pressure (CPAP) is a type of therapy that uses a high-pressure gas source to deliver constant positive pressure to the airways throughout both inspiration and expiration. This approach is expected to prevent some pulmonary complications, thus reducing mortality. OBJECTIVES: To determine whether any difference can be found in the rate of mortality and adverse events following major abdominal surgery in patients treated postoperatively with CPAP versus standard care, which may include traditional oxygen delivery systems, physiotherapy and incentive spirometry. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2013, Issue 9; Ovid MEDLINE (1966 to 15 September 2013); EMBASE (1988 to 15 September 2013); Web of Science (to September 2013) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (to September 2013). SELECTION CRITERIA: We included all randomized controlled trials (RCTs) in which CPAP was compared with standard care for prevention of postoperative mortality and adverse events following major abdominal surgery. We included all adults (adults as defined by individual studies) of both sexes. The intervention of CPAP was applied during the postoperative period. We excluded studies in which participants had received PEEP during surgery. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies that met the selection criteria from all studies identified by the search strategy. Two review authors extracted the data and assessed risk of bias separately, using a data extraction form. Data entry into RevMan was performed by one review author and was checked by another for accuracy. We performed a limited meta-analysis and constructed a summary of findings table. MAIN RESULTS: We selected 10 studies for inclusion in the review from 5236 studies identified in the search. These 10 studies included a total of 709 participants. Risk of bias for the included studies was assessed as high in six studies and as unclear in four studies.Two RCTs reported all-cause mortality. Among 413 participants, there was no clear evidence of a difference in mortality between CPAP and control groups, and considerable heterogeneity between trials was noted (risk ratio (RR) 1.28, 95% confidence interval (CI) 0.35 to 4.66; I(2) = 75%).Six studies reported demonstrable atelectasis in the study population. A reduction in atelectasis was observed in the CPAP group, although heterogeneity between studies was substantial (RR 0.62, 95% CI 0.45 to 0.86; I(2) = 61%). Pneumonia was reported in five studies, including 563 participants; CPAP reduced the rate of pneumonia, and no important heterogeneity was noted (RR 0.43, 95% CI 0.21 to 0.84; I(2) = 0%). The number of participants identified as having serious hypoxia was reported in two studies, with no clear difference between CPAP and control groups, given imprecise results and substantial heterogeneity between trials (RR 0.48, 95% CI 0.22 to 1.02; I(2) = 67%). A reduced rate of reintubation was reported in the CPAP group compared with the control group in two studies, and no important heterogeneity was identified (RR 0.14, 95% CI 0.03 to 0.58; I(2) = 0%). Admission into the intensive care unit (ICU) for invasive ventilation and supportive care was reduced in the CPAP group, but this finding did not reach statistical significance (RR 0.45, 95% CI 0.18 to 1.14; I(2) = 0).Secondary outcomes such as length of hospital stay and adverse effects were only minimally reported.A summary of findings table was constructed using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) principle. The quality of evidence was determined to be very low. AUTHORS' CONCLUSIONS: Very low-quality evidence from this review suggests that CPAP initiated during the postoperative period might reduce postoperative atelectasis, pneumonia and reintubation, but its effects on mortality, hypoxia or invasive ventilation are uncertain. Evidence is not sufficiently strong to confirm the benefits or harms of CPAP during the postoperative period in those undergoing major abdominal surgery. Most of the included studies did not report on adverse effects attributed to CPAP.New, high-quality research is much needed to evaluate the use of CPAP in preventing mortality and morbidity following major abdominal surgery. With increasing availability of CPAP to our surgical patients and its potential to improve outcomes (possibly in conjunction with intraoperative lung protective ventilation strategies), unanswered questions regarding its efficacy and safety need to be addressed. Any future study must report on the adverse effects of CPAP.

Preoperative carbohydrate treatment for enhancing recovery after elective surgery.

BACKGROUND: Preoperative carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been widely investigated and have been shown to be associated with improved postoperative outcomes, some individual constituents of these protocols, including preoperative carbohydrate treatment, have not been subject to such robust analysis. OBJECTIVES: To assess the effects of preoperative carbohydrate treatment, compared with placebo or preoperative fasting, on postoperative recovery and insulin resistance in adult patients undergoing elective surgery. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, Issue 3), MEDLINE (January 1946 to March 2014), EMBASE (January 1947 to March 2014), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (January 1980 to March 2014) and Web of Science (January 1900 to March 2014) databases. We did not apply language restrictions in the literature search. We searched reference lists of relevant articles and contacted known authors in the field to identify unpublished data. SELECTION CRITERIA: We included all randomized controlled trials of preoperative carbohydrate treatment compared with placebo or traditional preoperative fasting in adult study participants undergoing elective surgery. Treatment groups needed to receive at least 45 g of carbohydrates within four hours before surgery or anaesthesia start time. DATA COLLECTION AND ANALYSIS: Data were abstracted independently by at least two review authors, with discrepancies resolved by consensus. Data were abstracted and documented pro forma and were entered into RevMan 5.2 for analysis. Quality assessment was performed independently by two review authors according to the standard methodological procedures expected by The Cochrane Collaboration. When available data were insufficient for quality assessment or data analysis, trial authors were contacted to request needed information. We collected trial data on complication rates and aspiration pneumonitis. MAIN RESULTS: We included 27 trials involving 1976 participants Trials were conducted in Europe, China, Brazil, Canada and New Zealand and involved patients undergoing elective abdominal surgery (18), orthopaedic surgery (4), cardiac surgery (4) and thyroidectomy (1). Twelve studies were limited to participants with an American Society of Anaesthesiologists grade of I-II or I-III.A total of 17 trials contained at least one domain judged to be at high risk of bias, and only two studies were judged to be at low risk of bias across all domains. Of greatest concern was the risk of bias associated with inadequate blinding, as most of the outcomes assessed by this review were subjective. Only six trials were judged to be at low risk of bias because of blinding.In 19 trials including 1351 participants, preoperative carbohydrate treatment was associated with shortened length of hospital stay compared with placebo or fasting (by 0.30 days; 95% confidence interval (CI) 0.56 to 0.04; very low-quality evidence). No significant effect on length of stay was noted when preoperative carbohydrate treatment was compared with placebo (14 trials including 867 participants; mean difference -0.13 days; 95% CI -0.38 to 0.12). Based on two trials including 86 participants, preoperative carbohydrate treatment was also associated with shortened time to passage of flatus when compared with placebo or fasting (by 0.39 days; 95% CI 0.70 to 0.07), as well as increased postoperative peripheral insulin sensitivity (three trials including 41 participants; mean increase in glucose infusion rate measured by hyperinsulinaemic euglycaemic clamp of 0.76 mg/kg/min; 95% CI 0.24 to 1.29; high-quality evidence).As reported by 14 trials involving 913 participants, preoperative carbohydrate treatment was not associated with an increase or a decrease in the risk of postoperative complications compared with placebo or fasting (risk ratio of complications 0.98, 95% CI 0.86 to 1.11; low-quality evidence). Aspiration pneumonitis was not reported in any patients, regardless of treatment group allocation. AUTHORS' CONCLUSIONS: Preoperative carbohydrate treatment was associated with a small reduction in length of hospital stay when compared with placebo or fasting in adult patients undergoing elective surgery. It was found that preoperative carbohydrate treatment did not increase or decrease postoperative complication rates when compared with placebo or fasting. Lack of adequate blinding in many studies may have contributed to observed treatment effects for these subjective outcomes, which are subject to possible biases.

Feedback or biofeedback to augment pelvic floor muscle training for urinary incontinence in women: shortened version of a Cochrane systematic review.

BACKGROUND: Feedback and biofeedback (BF) are common adjuncts to pelvic floor muscle training (PFMT) for women with stress, urgency, and mixed urinary incontinence (UI). An up to date systematic review of adjunctive feedback or BF was needed to guide practice and further research. OBJECTIVES: To determine whether feedback or BF add benefit to PFMT for women with UI. METHODS: The Cochrane Incontinence Group Specialised Trials Register was searched (May 2010) for randomised or quasi-randomized trials in women with stress, urgency or mixed UI regardless of cause, which compared PFMT versus PFMT augmented with feedback or BF. Two reviewers independently undertook eligibility screening, risk of bias assessment and data extraction. Analysis was in accordance with the Cochrane Handbook for Systematic Reviews of Intervention (version 5.0.2). RESULTS: Twenty-four trials were included, and many were at moderate to high risk of bias. Women who received BF were less likely to report they were not improved (RR 0.75, 95% CI: 0.66-0.86), although there was no statistically significant difference for cure (RR 0.92, 95% CI: 0.81-1.05) and marginal statistical significance for leakage episodes (mean difference: -0.12 leaks/day, 95% CI: -0.22 to -0.01). It is possible the results are confounded because women in the BF group commonly had more contact with the health professional than those in the PFMT only arm. CONCLUSION: BF may add benefit to PFMT but the observed effect could well be related to another variable, such as the amount of health professional contact rather than the BF per se.

Weighted vaginal cones for urinary incontinence.

BACKGROUND: For a long time pelvic floor muscle training (PFMT) has been the most common form of conservative (non-surgical) treatment for stress urinary incontinence (SUI). Weighted vaginal cones can be used to help women to train their pelvic floor muscles. Cones are inserted into the vagina and the pelvic floor is contracted to prevent them from slipping out. OBJECTIVES: The objective of this review is to determine the effectiveness of vaginal cones in the management of female urinary stress incontinence (SUI).We wished to test the following comparisons in the management of stress incontinence: 1. vaginal cones versus no treatment; 2. vaginal cones versus other conservative therapies, such as PFMT and electrostimulation; 3. combining vaginal cones and another conservative therapy versus another conservative therapy alone or cones alone; 4. vaginal cones versus non-conservative methods, for example surgery or injectables.Secondary issues which were considered included whether:1. it takes less time to teach women to use cones than it does to teach the pelvic floor exercise; 2. self-taught use is effective;3. the change in weight of the heaviest cone that can be retained is related to the level of improvement;4. subgroups of women for whom cone use may be particularly effective can be identified. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Trials Register (searched 19 September 2012), MEDLINE (January 1966 to March 2013), EMBASE (January 1988 to March 2013) and reference lists of relevant articles. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials comparing weighted vaginal cones with alternative treatments or no treatment. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed studies for inclusion and trial quality. Data were extracted by one reviewer and cross-checked by the other. Study authors were contacted for extra information. MAIN RESULTS: We included 23 trials involving 1806 women, of whom 717 received cones. All of the trials were small, and in many the quality was hard to judge. Outcome measures differed between trials, making the results difficult to combine. Some trials reported high drop-out rates with both cone and comparison treatments. Seven trials were published only as abstracts.Cones were better than no active treatment (rate ratio (RR) for failure to cure incontinence 0.84, 95% confidence interval (CI) 0.76 to 0.94). There was little evidence of difference for a subjective cure between cones and PFMT (RR 1.01, 95% CI 0.91 to 1.13), or between cones and electrostimulation (RR 1.26, 95% CI 0.85 to 1.87), but the confidence intervals were wide. There was not enough evidence to show that cones plus PFMT was different to either cones alone or PFMT alone. Only seven trials used a quality of life measures and no study looked at economic outcomes.Seven of the trials recruited women with symptoms of incontinence, while the others required women with urodynamic stress incontinence, apart from one where the inclusion criteria were uncertain. AUTHORS' CONCLUSIONS: This review provides some evidence that weighted vaginal cones are better than no active treatment in women with SUI and may be of similar effectiveness to PFMT and electrostimulation. This conclusion must remain tentative until larger, high-quality trials, that use comparable and relevant outcomes, are completed. Cones could be offered as one treatment option, if women find them acceptable.

Interventions for protecting renal function in the perioperative period.

BACKGROUND: Various methods have been used to try to protect kidney function in patients undergoing surgery. These most often include pharmacological interventions such as dopamine and its analogues, diuretics, calcium channel blockers, angiotensin-converting enzyme (ACE) inhibitors, N-acetyl cysteine (NAC), atrial natriuretic peptide (ANP), sodium bicarbonate, antioxidants and erythropoietin (EPO). OBJECTIVES: This review is aimed at determining the effectiveness of various measures advocated to protect patients' kidneys during the perioperative period.We considered the following questions: (1) Are any specific measures known to protect kidney function during the perioperative period? (2) Of measures used to protect the kidneys during the perioperative period, does any one method appear to be more effective than the others? (3) Of measures used to protect the kidneys during the perioperative period,does any one method appear to be safer than the others? SEARCH METHODS: In this updated review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 2, 2012), MEDLINE (Ovid SP) (1966 to August 2012) and EMBASE (Ovid SP) (1988 to August 2012). We originally handsearched six journals (Anesthesia and Analgesia, Anesthesiology, Annals of Surgery, British Journal of Anaesthesia, Journal of Thoracic and Cardiovascular Surgery, and Journal of Vascular Surgery) (1985 to 2004). However, because these journals are properly indexed in MEDLINE, we decided to rely on electronic searches only without handsearching the journals from 2004 onwards. SELECTION CRITERIA: We selected all randomized controlled trials in adults undergoing surgery for which a treatment measure was used for the purpose of providing renal protection during the perioperative period. DATA COLLECTION AND ANALYSIS: We selected 72 studies for inclusion in this review. Two review authors extracted data from all selected studies and entered them into RevMan 5.1; then the data were appropriately analysed. We performed subgroup analyses for type of intervention, type of surgical procedure and pre-existing renal dysfunction. We undertook sensitivity analyses for studies with high and moderately good methodological quality. MAIN RESULTS: The updated review included data from 72 studies, comprising a total of 4378 participants. Of these, 2291 received some form of treatment and 2087 acted as controls. The interventions consisted most often of different pharmaceutical agents, such as dopamine and its analogues, diuretics, calcium channel blockers, ACE inhibitors, NAC, ANP, sodium bicarbonate, antioxidants and EPO or selected hydration fluids. Some clinical heterogeneity and varying risk of bias were noted amongst the studies, although we were able to meaningfully interpret the data. Results showed significant heterogeneity and indicated that most interventions provided no benefit.Data on perioperative mortality were reported in 41 studies and data on acute renal injury in 44 studies (all interventions combined). Because of considerable clinical heterogeneity (different clinical scenarios, as well as considerable methodological variability amongst the studies), we did not perform a meta-analysis on the combined data.Subgroup analysis of major interventions and surgical procedures showed no significant influence of interventions on reported mortality and acute renal injury. For the subgroup of participants who had pre-existing renal damage, the risk of mortality from 10 trials (959 participants) was estimated as odds ratio (OR) 0.76, 95% confidence interval (CI) 0.38 to 1.52; the risk of acute renal injury (as reported in the trials) was estimated from 11 trials (979 participants) as OR 0.43, 95% CI 0.23 to 0.80. Subgroup analysis of studies that were rated as having low risk of bias revealed that 19 studies reported mortality numbers (1604 participants); OR was 1.01, 95% CI 0.54 to 1.90. Fifteen studies reported data on acute renal injury (criteria chosen by the individual studies; 1600 participants); OR was 1.03, 95% CI 0.54 to 1.97. AUTHORS' CONCLUSIONS: No reliable evidence from the available literature suggests that interventions during surgery can protect the kidneys from damage. However, the criteria used to diagnose acute renal damage varied in many of the older studies selected for inclusion in this review, many of which suffered from poor methodological quality such as insufficient participant numbers and poor definitions of end points such as acute renal failure and acute renal injury. Recent methods of detecting renal damage such as the use of specific biomarkers and better defined criteria for identifying renal damage (RIFLE (risk, injury, failure, loss of kidney function and end-stage renal failure) or AKI (acute kidney injury)) may have to be explored further to determine any possible benefit derived from interventions used to protect the kidneys during the perioperative period.

Development of clinical priority access criteria for assisted reproduction and its evaluation on 1386 infertile couples in New Zealand.

BACKGROUND: In New Zealand ranking patients for elective, publicly funded procedures uses clinical priority access criteria (CPAC). A CPAC to prioritize patients seeking assisted reproductive technology (ART) was developed in 1997 and implemented nationwide in 2000. This study describes the development of the ART CPAC tool and its evaluation on 1386 couples referred to a single tertiary service from 1998 to 2005. METHODS: A total of 48 health professionals and consumers assisted in criteria development. A score between 0 and 100 points was calculated for each couple and those who reached ≥65 points were eligible for publicly funded ART. Couples beneath the treatment threshold were placed on active review; the review being the date the score was calculated to reach the treatment threshold. Couples who would never be eligible or who were on active review were offered private treatment. Treatments and outcomes (spontaneous and treatment dependent live birth pregnancies) were used to evaluate the criteria. RESULTS: Three social criteria (duration infertility, number of children and sterilization status) and two objective criteria (diagnosis and female age) formed the priority score. Of the evaluated couples, 643 (46%) were eligible within 1 year of referral (Group 1), 451 (33%) >1-5 years from referral (Group 2) and 292 (21%) couples were never eligible (Group 3). The predominant ART was IVF. A total of 480 couples had at least one IVF treatment with 404 (84%) having publicly funded treatment. A total of 762 (55%) women gave birth, 473 from treatment and 289 spontaneously. Group 1 had more pregnancies from treatment while Group 2 had most pregnancies overall being mainly from spontaneous pregnancies. Compared with Group 3 cases the hazard ratio using time to spontaneous live birth pregnancy for Group 1 couples was significantly lower, 0.51 (95% confidence interval 0.36-0.74) and for Group 2 cases significantly higher, 1.86, (1.35-2.58). Treatments using ART were evaluated for the three eligibility groups, with the never eligible divided into women age <40 (Group 3a) and woman age ≥40 at referral (Group 3b). Compared with Group 1 cases the hazard ratio to treatment dependent live birth pregnancy was similar for Groups 2 and 3a but significantly lower for Group 3b (0.37, 0.14-0.90). CONCLUSIONS: The clinical priority access score was able to discriminate between the chance of pregnancy with and without treatment and those offered and not offered treatment. The CPAC is a useful model for informing the allocation of public funding for ART in other countries.

Interventions for treating acute elbow dislocations in adults.

BACKGROUND: Dislocation of the elbow joint is a relatively uncommon injury. OBJECTIVES: To assess the effects of various forms of treatment for acute simple elbow dislocations in adults. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (April 2011), the Cochrane Central Register of Controlled Trials (The Cochrane Library, 2011 Issue 1), MEDLINE (1948 to March Week 5 2011), EMBASE (1980 to 2011 Week 14), PEDro (April 2011), CINAHL (April 2011), various trial registers, various conference proceedings and bibliographies of relevant articles. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials of conservative and surgical treatment of dislocations of the elbow in adults. Excluded were trials involving dislocations with associated fractures, except for avulsion fractures. DATA COLLECTION AND ANALYSIS: Data extraction and assessment of risk of bias were independently performed by two review authors. There was no pooling of data. MAIN RESULTS: Two small randomised controlled trials, involving a total of 80 participants with simple elbow dislocations, were included. Both trials were methodologically flawed and potentially biased.One trial, involving 50 participants, compared early mobilisation at three days post reduction versus cast immobilisation. At one year follow-up, the recovery of range of motion appeared better in the early mobilisation group (e.g. participants with incomplete recovery of extension: 1/24 versus 5/26; risk ratio 0.22, 95% confidence interval 0.03 to 1.72). However, the results were not statistically significant. There were no reports of instability or recurrence. One person in each group had residual pain at one year.The other trial, involving 30 participants, compared surgical repair of the torn ligaments versus conservative treatment (cast immobilisation for two weeks). At final follow-up (mean 27.5 months), there were no statistically significant differences between the two groups in the numbers of patients who considered their injured elbow to be inferior to their non-injured elbow (10/14 versus 7/14; RR 1.43, 95% CI 0.77 to 2.66) or in other patient complaints about their elbow such as weakness, pain or weather-related discomfort. There were no reports of instability or recurrence. There were no statistically significant differences between the two groups in range of motion of the elbow (extension, flexion, pronation, and supination) or grip strength at follow-up. No participants had neurological disturbances of the hand but two surgical group participants had recurrent dislocation of the ulnar nerve (no other details provided). One person in each group had radiologically detected myositis ossificans (bone formation within muscles following injury). AUTHORS' CONCLUSIONS: There is insufficient evidence from randomised controlled trials to determine which method of treatment is the most appropriate for simple dislocations of the elbow in adults. Although weak and inconclusive, the available evidence from a trial comparing surgery versus conservative treatment does not suggest that the surgical repair of elbow ligaments for simple elbow dislocation improves long-term function. Future research should focus on questions relating to non-surgical treatment, such as the duration of immobilisation.

Which anticholinergic drug for overactive bladder symptoms in adults.

BACKGROUND: Around 16% to 45% of adults have overactive bladder symptoms (urgency with frequency and/or urge incontinence - 'overactive bladder syndrome'). Anticholinergic drugs are common treatments. OBJECTIVES: To compare the effects of different anticholinergic drugs for overactive bladder symptoms. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Trials Register (searched 8 March 2011) and reference lists of relevant articles. SELECTION CRITERIA: Randomised trials in adults with overactive bladder symptoms or detrusor overactivity that compared one anticholinergic drug with another, or two doses of the same drug. DATA COLLECTION AND ANALYSIS: Two authors independently assessed eligibility, trial quality and extracted data. Data were processed as described in the Cochrane Reviewers' Handbook. MAIN RESULTS: Eighty six trials, 70 parallel and 16 cross-over designs were included (31,249 adults). Most trials were described as double-blind, but were variable in other aspects of quality. Crossover studies did not present data in a way that could be included in the meta-analyses. Twenty nine collected quality of life data (the primary outcome measure) using validated measures, but only fifteen reported useable data.Tolterodine versus oxybutynin: There were no statistically significant differences for quality of life, patient reported cure or improvement, leakage episodes or voids in 24 hours, but fewer withdrawals due to adverse events with tolterodine (Risk Ratio (RR) 0.52, 95% confidence interval (CI) 0.40 to 0.66, data from eight trials), and less risk of dry mouth (RR 0.65, 95% CI 0.60 to 0.71, data from ten trials).Solifenacin versus tolterodine: There were statistically significant differences for quality of life (standardised mean difference (SMD) -0.12, 95% CI -0.23 to -0.01, data from three trials), patient reported cure/improvement (RR 1.25, 95% CI 1.13 to 1.39, data from two trials), leakage episodes in 24 hours (weighted mean difference (WMD) -0.30, 95% CI -0.53 to -0.08, data from four studies) and urgency episodes in 24 hours (WMD -0.43, 95% CI -0.74 to -0.13, data from four trials), all favouring solifenacin. There was no difference in withdrawals due to adverse events and dry mouth, but after sensitivity analysis the dry mouth (RR 0.69, 95% CI 0.51 to 0.94) was statistically significantly lower with solifenacin when compared to Immediate Release (IR) tolterodine.Fesoterodine versus extended release tolterodine: Three trials contributed to the meta analyses. There were statistically significant differences for quality of life (SMD -0.20, 95% CI -0.27 to -0.14), patient reported cure/improvement (RR 1.11, 95% CI 1.06 to 1.16), leakage episodes (WMD -0.19, 95% CI -0.30 to -0.09), frequency (WMD -0.27, 95% CI -0.47 to -0.06) and urgency episodes (WMD -0.44, 95% CI -0.72 to -0.16) in 24 hours, all favouring fesoterodine, but those taking fesoterodine had higher risk of withdrawal due to adverse events (RR 1.45, 95% CI 1.07 to 1.98) and higher risk of dry mouth (RR 1.80, 95% CI 1.58 to 2.05) at 12 weeks.Different doses of tolterodine: The standard recommended starting dose (2 mg twice daily) was compared with two lower (0.5 mg and 1 mg twice daily), and one higher dose (4 mg twice daily). The effects of 1 mg, 2 mg and 4 mg doses were similar for leakage episodes and micturitions in 24 hours, with greater risk of dry mouth with 2 and 4 mg doses at two to 12 weeks.Different doses of solifenacin: The standard recommended starting dose of 5 mg once daily was compared to 10 mg: while frequency and urgency were less (better) with 10 mg compared to 5 mg, there was a higher risk of dry mouth with 10 mg solifenacin at four to 12 weeks.Different doses of fesoterodine:The recommended starting dose of 4mg once daily was compared to 8 and 12 mg. The clinical efficacy (patient reported cure, leakage episodes, micturition per 24 hours) of 8 mg was better than 4 mg fesoterodine but with a higher risk of dry mouth with 8 mg.There was no statistically significant difference between 4 and 12 mg in the efficacy but the dry mouth was significantly higher with 12 mg at eight to 12 weeks.Extended versus immediate release preparations of oxybutynin and/or tolterodine: There were no statistically significant differences for cure/improvement, leakage episodes or micturitions in 24 hours, or withdrawals due to adverse events, but there were few data. Overall, extended release preparations had less risk of dry mouth at two to 12 weeks.One extended release preparation versus another: There was less risk of dry mouth with oral extended release tolterodine than oxybutynin (RR 0.75, 95% CI 0.59 to 0.95), but no difference between transdermal oxybutynin and oral extended release tolterodine although some people withdrew due to skin reaction at the transdermal patch site at 12 weeks. AUTHORS' CONCLUSIONS: Where the prescribing choice is between oral immediate release oxybutynin or tolterodine, tolterodine might be preferred for reduced risk of dry mouth. With tolterodine, 2 mg twice daily is the usual starting dose, but a 1 mg twice daily dose might be equally effective, with less risk of dry mouth. If extended release preparations of oxybutynin or tolterodine are available, these might be preferred to immediate release preparations because there is less risk of dry mouth.Between solifenacin and immediate release tolterodine, solifenacin might be preferred for better efficacy and less risk of dry mouth. Solifenacin 5 mg once daily is the usual starting dose, this could be increased to 10 mg once daily for better efficacy but with increased risk of dry mouth.Between fesoterodine and extended release tolterodine, fesoterodine might be preferred for superior efficacy but has higher risk of withdrawal due to adverse events and higher risk of dry mouth.There is little or no evidence available about quality of life, costs, or long-term outcome in these studies. There were insufficient data from trials of other anticholinergic drugs to draw any conclusions.

Traumatic and non-traumatic spinal cord impairment in New Zealand: incidence and characteristics of people admitted to spinal units.

This paper estimates the incidence (all ages) of spinal cord neurological impairment (SCI; traumatic and non-traumatic) in New Zealand and describes pre-SCI characteristics and early post-SCI outcomes for participants (16-64 years) in this longitudinal study. Demographic and clinical data on all people admitted to New Zealand's two spinal units (mid-2007 to mid-2009) were included for the estimate of incidence. Participants in this longitudinal study were asked at first interview about pre-SCI socio-demographic, health and behavioural characteristics, and about post-SCI symptoms, general health status (EQ-5D) and disability (WHODAS 12-item). Age-adjusted incidence rates (95% CI) for European, Maori, Pacific and 'Other' ethnicities were 29 (24-34), 46 (30-64), 70 (40-100) and 16 (9-22) per million, respectively. Interviews with 118 (73%) participants (16-64 years), occurred 6.5 months post-SCI. Most reported bother with symptoms, and problems with health status and disability. Compared with Europeans, the incidence of SCI is high among Maori and particularly high among Pacific people. Six months after SCI, proximate to discharge from the spinal units, considerable symptomatic, general health and disability burden was borne by people with SCI.

Botulinum toxin injections for adults with overactive bladder syndrome.

BACKGROUND: Overactive bladder syndrome (OAB) is a common condition with a significant negative impact on quality of life characterised by urgency with or without urge incontinence, frequency and nocturia.  Intravesical botulinum toxin is being increasingly used to treat severe overactive bladder refractory to standard management.  An increasing body of literature is forming that supports this technique as effective, well tolerated, and safe.  This review is a substantial update of the 2007 review of the same title. OBJECTIVES: The objective was to compare intravesical botulinum toxin with other treatments for neurogenic and idiopathic overactive bladder in adults. The hypothesis to be addressed were whether intravesical injection of botulinum toxin was better than placebo or no treatment; pharmacological and other non-pharmacological interventions; whether higher doses of botulinum toxin were better than lower doses; whether botulinum toxin in combination with other treatments was better than other treatments alone; whether one formulation of botulinum toxin is better than another; and whether one injection technique was better than another. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Trials Register (searched 23 February 2010). The Register contains trials identified from MEDLINE, CINAHL, the Cochrane Central Register of Controlled Trials (CENTRAL), and handsearching of journals and conference proceedings. Additionally, all reference lists of selected trials and relevant review papers were searched. No limitations were placed on the searches. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials of treatment for OAB in adults in which at least one management arm involved intravesical injection of botulinum toxin were included. Participants had either neurogenic OAB or idiopathic OAB with or without stress incontinence. Comparison interventions could include no intervention, placebo, lifestyle modification, bladder retraining, pharmacological treatments, surgery, bladder instillation techniques, neuromodulation, and different types, doses, and injection techniques of botulinum toxin. DATA COLLECTION AND ANALYSIS: Binary outcomes were presented as relative risk and continuous outcomes by mean differences. Little data could be synthesised across studies due to differing study designs and outcome measures. Where applicable standard deviations were calculated from P values according to the formula described in section 7.7.3.3 of the Cochrane Handbook of Systematic Reviews of Interventions. Data were tabulated where possible with results taken from trial reports where this was not possible. Where multiple publications were found, the reports were treated as a single source of data. MAIN RESULTS: Nineteen studies were identified that met the inclusion criteria.  Most patients in the studies had neurogenic OAB, but some included patients with idiopathic OAB.  All studies demonstrated superiority of botulinum toxin to placebo.  Lower doses of botulinum toxin (100 to 150 U) appeared to have beneficial effects, but larger doses (300 U) may have been more effective and longer lasting, but with more side effects.  Suburothelial injection had comparable efficacy to intradetrusor injection. The effect of botulinum toxin may last for a number of months and is dependent upon dose and type of toxin used. Patients receiving repeated doses do not seem to become refractory to botulinum toxin. Botulinum toxin appeared to have beneficial effects in OAB that quantitatively exceeded the effects of intravesical resiniferatoxin. Intravesical botulinum toxin appeared to be reasonably safe; however, one study was halted due to a perceived unacceptable rate of urinary retention.  AUTHORS' CONCLUSIONS: Intravesical botulinum toxin appears to be an effective therapy for refractory OAB symptoms, but as yet little controlled trial data exist on benefits and safety compared with other interventions, or with placebo. Further robust data are required on long term outcomes, safety, and optimal dose of botulinum toxin for OAB.

Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women.

BACKGROUND: Pelvic floor muscle training is the most commonly recommended physical therapy treatment for women with stress urinary incontinence. It is also sometimes recommended for mixed and, less commonly, urge urinary incontinence. The supervision and content of pelvic floor muscle training programmes are highly variable, and some programmes use additional strategies in an effort to increase adherence or training effects. OBJECTIVES: To compare the effects of different approaches to pelvic floor muscle training for women with urinary incontinence. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Trials Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and CINAHL, and handsearching of journals and conference proceedings (searched 17 May 2011), and the reference lists of relevant articles. SELECTION CRITERIA: Randomised trials or quasi-randomised trials in women with stress, urge or mixed urinary incontinence (based on symptoms, signs or urodynamics). One arm of the study included pelvic floor muscle training. Another arm was an alternative approach to pelvic floor muscle training, such as a different way of teaching, supervising or performing pelvic floor muscle training. DATA COLLECTION AND ANALYSIS: We independently assessed trials for eligibility and methodological quality. We extracted then cross-checked data. We resolved disagreements by discussion. We processed data as described in the Cochrane Handbook for Systematic Reviews of Interventions (version 5.2.2). We subgrouped trials by intervention. MAIN RESULTS: We screened 574 records for eligibility and included 21 trials in the review. The 21 trials randomised 1490 women and addressed 11 comparisons. These were: differences in training supervision (amount, individual versus group), in approach (one versus another, the effect of an additional component) and the exercise training (type of contraction, frequency of training). In women with stress urinary incontinence, 10% of those who received weekly or twice-weekly group supervision in addition to individual appointments with the therapist did not report improvement post-treatment compared to 43% of the group who had individual appointments only (risk ratio (RR) for no improvement 0.29, 95% confidence interval (CI) 0.15 to 0.55, four trials). Looking at this another way, 90% of those who had combined group and individual supervision reported improvement versus 57% of women receiving individual supervision only. While women receiving the combination of frequent group supervision and individual supervision of pelvic floor muscle training were more likely to report improvement, the confidence interval was wide, and more than half of the 'control' group (the women who did not get the additional weekly or twice-weekly group supervision) reported improvement. This finding, of subjective improvement in both active treatment groups, with more improvement reported by those receiving more health professional contact, was consistent throughout the review.We feel there are several reasons why caution is needed when interpreting the results of the review: there were few data in any comparison; a number of trials were confounded by comparing two arms with multiple differences in the approaches to pelvic floor muscle training; there was a likelihood of a relationship between attention and reporting of more improvement in women who were not blind to treatment allocation; some trials chose interventions that were unlikely to have a muscle training effect; and some trials did not adequately describe their intervention. AUTHORS' CONCLUSIONS: This review found that the existing evidence was insufficient to make any strong recommendations about the best approach to pelvic floor muscle training. We suggest that women are offered reasonably frequent appointments during the training period, because the few data consistently showed that women receiving regular (e.g. weekly) supervision were more likely to report improvement than women doing pelvic floor muscle training with little or no supervision.

Feedback or biofeedback to augment pelvic floor muscle training for urinary incontinence in women.

BACKGROUND: Pelvic floor muscle training (PFMT) is an effective treatment for stress urinary incontinence in women. Whilst most of the PFMT trials have been done in women with stress urinary incontinence, there is also some trial evidence that PFMT is effective for urgency urinary incontinence and mixed urinary incontinence. Feedback or biofeedback are common adjuncts used along with PFMT to help teach a voluntary pelvic floor muscle contraction or to improve training performance. OBJECTIVES: To determine whether feedback or biofeedback adds further benefit to PFMT for women with urinary incontinence.To compare the effectiveness of different forms of feedback or biofeedback. SEARCH STRATEGY: We searched the Cochrane Incontinence Group Specialised Trials Register (searched 13 May 2010) and the reference lists of relevant articles. SELECTION CRITERIA: Randomised or quasi-randomised trials in women with stress, urgency or mixed urinary incontinence (based on symptoms, signs or urodynamics). At least two arms of the trials included PFMT. In addition, at least one arm included verbal feedback or device-mediated biofeedback. DATA COLLECTION AND ANALYSIS: Trials were independently assessed for eligibility and risk of bias. Data were extracted by two reviewers and cross-checked. Disagreements were resolved by discussion or the opinion of a third reviewer. Data analysis was conducted in accordance with the Cochrane Handbook for Systematic Reviews of Intervention (version 5.1.0). Analysis within subgroups was based on whether there was a difference in PFMT between the two arms that had been compared. MAIN RESULTS: Twenty four trials involving 1583 women met the inclusion criteria; 17 trials contributed data to analysis for one of the primary outcomes. All trials contributed data to one or more of the secondary outcomes. Women who received biofeedback were significantly more likely to report that their urinary incontinence was cured or improved compared to those who received PFMT alone (risk ratio 0.75 , 95% confidence interval 0.66 to 0.86). However, it was common for women in the biofeedback arms to have more contact with the health professional than those in the non-biofeedback arms. Many trials were at moderate to high risk of bias, based on trial reports. There was much variety in the regimens proposed for adding feedback or biofeedback to PFMT alone, and it was often not clear what the actual intervention comprised or what the purpose of the intervention was. AUTHORS' CONCLUSIONS: Feedback or biofeedback may provide benefit in addition to pelvic floor muscle training in women with urinary incontinence. However, further research is needed to differentiate whether it is the feedback or biofeedback that causes the beneficial effect or some other difference between the trial arms (such as more contact with health professionals).

Recovery after injury: an individual patient data meta-analysis of general health status using the EQ-5D.

BACKGROUND: General information of health-related quality of life pathways to recovery after injury are largely absent from the literature. This article describes a study which: (1) collated and synthesized individual patient data of injured persons from an earlier systematic review and (2) produced general predictions of health-related quality of life for different injury groups for up to 1 year postinjury. METHODS: A systematic search of literature from January 1990 to December 2008 was completed. Researchers were approached to share their anonymous individual level data. Injuries were grouped into 39 categories based on the Eurocost injury classifications. Multilevel mixed effects models were used to produce predictions across both the five dimensions and the visual analog scale of the EQ-5D measure at 3 days, 30 days, 120 days, and 360 days postinjury. RESULTS: Individual patient data from 10,496 injured persons (76% of known data worldwide) was retrieved. Predictions were fitted to 27 of the 39 injury categories covering a wide spectrum of injury types. Across most injuries, pain, or discomfort, usual activities and mobility were the most commonly impaired dimensions. Recovery for pain or discomfort was generally more gradual than other health dimensions. For many injury categories, a considerable proportion of people reported residual impairment at 360 days. Regardless of the anatomic location of injury, similar patterns of recovery or persistent impairment were seen for fractures and strains/sprains. Recovery patterns differed and took much longer than estimated in the Global Burden of Disease Study. CONCLUSIONS: This study has produced recovery patterns for 27 injury groups using most of the worldwide individual-level data. For many injury categories, recovery is incomplete and takes much longer than estimated. This study infers that the burden of injury is likely being underestimated.

A longitudinal study of the life histories of people with spinal cord injury.

BACKGROUND: Approximately 70-80 New Zealanders have spinal cord impairment (SCI) due to injury (2/3) or disease (1/3) each year. They had been socialized as non-disabled people. Following paralysis, interrelationships between body, self and society change. Little is known of the impact of these changes on life histories, life chances and life choices of people with SCI. This has negative implications for the design of rehabilitation and disability support services in New Zealand. Furthermore, the trajectory of disability is affected by previous socioeconomic conditions. How specific supports following SCI (eg, rehabilitation and compensation funded by the Accident Compensation Corporation; ACC) can change this trajectory is unknown. OBJECTIVES: To explore the interrelationships of body, self and society for people with SCI and how these have shaped life chances, life choices and subjectivity. To investigate how entitlement to rehabilitation and compensation through ACC affects socioeconomic and health outcomes. SETTING: New Zealand. DESIGN: A prospective cohort study; mixed methods. PARTICIPANTS: 112 people with SCI admitted for the first time to one of New Zealand's two spinal units without serious cognitive injury. DATA: Structured interviews with all participants (n=112); qualitative interviews with a selected subgroup (n=20); clinical data collected at the time of admission. Exposures include: demographics, comorbidity, previous health and socioeconomic status, SCI resulting from illness or injury, income support, health and social services. OUTCOME MEASURES: Socioeconomic status, health, participation and life satisfaction. ANALYSIS: Descriptive statistics; differences tested by paired t tests or McNemar tests; multiple regression and mixed models. Qualitative analysis will be interpretive.

Placebo run-in periods in anticholinergic trials are not associated with treatment effect size or risk of attrition: an empirical evaluation.

OBJECTIVES: We aimed to explore the impact of run-in periods on the magnitude of treatment effect and the risk of attrition in a sample of randomized trials. STUDY DESIGN AND SETTING: We identified randomized trials from a published systematic review examining the effects of anticholinergics for the treatment of overactive bladders. We fitted meta-analytic mixed-effects models to assess whether the type of run-in (placebo run-in vs. no run-in) was associated with the magnitude of the effect estimates for the following outcomes: the number of voids per day, number of leakages per day, presence of dry mouth, cure/improvement, patient withdrawal from the trial, compliance with the trial protocol, and/or adherence to study drug. We adjusted for potential confounders. RESULTS: A total of 96 trials met the eligibility criteria; 59 trials had no run-in (which included those with a screening or withdrawal period), 37 trials had a placebo run-in, and no trials had a drug run-in. The magnitude of the effect estimates for all outcomes did not importantly differ between trials with a placebo run-in and trials with no run-in. Adjustment for the confounding variables did not materially change the estimates. CONCLUSION: The hypothesized benefits of placebo run-in periods were not observed in our sample of anticholinergic randomized trials for the treatment of overactive bladders. Designing future trials of anticholinergics with more pragmatic intentions is likely to result in evidence that more directly informs clinical decision-making.

Sacral neuromodulation with implanted devices for urinary storage and voiding dysfunction in adults.

BACKGROUND: The neural control of storage and voiding of urine is complex and dysfunction can be difficult to treat. One treatment for people with refractory symptoms is continuous electrical nerve stimulation of the sacral nerve roots using implanted electrodes and an implanted pulse generator. OBJECTIVES: To determine the effects of implantable electrical stimulation devices in the treatment of urine storage and voiding problems. SEARCH STRATEGY: We searched the Cochrane Incontinence Group Specialised Register (searched 10 February 2009), CENTRAL (The Cochrane Library 2008, Issue 1), MEDLINE (January 1980 to March 2008), EMBASE (January 1980 to March 2008), CINAHL (January 1982 to March 2008) and the reference lists of relevant articles. SELECTION CRITERIA: Trials that tested implanted electronic stimulators connected to electrodes attached to the nerves and providing continuous electrical stimulation for neuromodulation. DATA COLLECTION AND ANALYSIS: Both authors selected studies, assessed quality, and extracted data. MAIN RESULTS: Eight reports of randomised studies that evaluated implants which provided continuous stimulation were included. It was unclear whether some reports included patients who also appeared in other reports, so no data were pooled. In spite of this, it seems clear that continuous stimulation offers benefits for carefully selected people with overactive bladder syndrome and for those with urinary retention but no structural obstruction.Many of the implants did not work and many required revision operations. Many questions remain about patient selection and the best way to use these devices. AUTHORS' CONCLUSIONS: In spite of methodological problems, it would appear that some people benefit from implants which provide continuous nerve stimulation. More research is needed on the best way to improve patient selection, carry out the implant, and to find why so many fail. The effectiveness of implants should be tested against other interventions, particularly in people with an overactive bladder.

The association between obesity and asthma: interactions between systemic and airway inflammation.

RATIONALE: Both obesity and asthma are common conditions, and both are characterized by the presence of inflammation. Animal studies suggest that the development of airway hyperresponsiveness with antigen challenge is exaggerated with obesity. However, clear evidence for either an additive or a synergistic pathologic interaction between obesity and asthma is lacking in humans. OBJECTIVES: To identify whether an interaction between systemic and local inflammation occurs in obese subjects with asthma in a controlled observational study. METHODS: We studied 79 women: obese patients with asthma (n = 20), normal-weight patients with asthma (n = 19), obese patients without asthma (n = 20), and normal-weight patients without asthma (n = 20). After corticosteroid withdrawal, between-group differences in spirometric values, lung volumes, exhaled nitric oxide, induced sputum cell counts, and biomarkers of inflammation in sputum supernatant and blood were measured, and interactions explored. MEASUREMENTS AND MAIN RESULTS: Markers of systemic inflammation were increased with obesity, and Th2 cytokines were increased with asthma, but no important interactions were identified. Obesity adversely affected lung function with increases in functional residual capacity and residual volume in obese but not normal-weight patients with asthma, with a significant obesity by asthma interaction. CONCLUSIONS: The link between obesity and asthma is unlikely to be explained by enhancement of the "classical" forms of airway inflammation resulting from the systemic inflammatory effects of obesity itself. Other mechanisms, possibly related to innate immunity, may explain the relationship between obesity and asthma.