Management of lower limb complex regional pain syndrome type 1: an evaluation of percutaneous radiofrequency thermal lumbar sympathectomy versus phenol lumbar sympathetic neurolysis--a pilot study. Strategies for improving the quality of health care in maternal and child health in low- and middle-income countries: an overview of systematic reviews. Outcome reporting in industry-sponsored trials of gabapentin for off-label use. Implementation of evidence-based preventive services delivery processes in primary care: an Oklahoma Physicians Resource/Research Network (OKPRN) study. Reversible cardiac sympathectomy by high thoracic epidural anesthesia improves regional left ventricular function in patients undergoing coronary artery bypass grafting: a randomized trial. Randomized controlled trials in pediatric surgery: could we do better? Repetitive transcranial magnetic stimulation of the motor cortex attenuates pain perception in complex regional pain syndrome type I. Ingrowing toenails: studies of segmental chemical ablation. Gabapentin in neuropathic pain syndromes: a randomised, double-blind, placebo-controlled trial. Appraising the evidence: applying sex- and gender-based analysis (SGBA) to Cochrane systematic reviews on cardiovascular diseases. An exploratory study of assertive community treatment for people with intellectual disability and psychiatric disorders: conceptual, clinical, and service issues.
Complex regional pain syndrome type 1 can be difficult to treat. The purpose of this study was to compare the safety and efficacy of two therapeutic options: percutaneous radiofrequency thermal lumbar sympathectomy and lumbar sympathetic neurolysis.
                We randomized 20 patients to receive percutaneous radiofrequency lumbar sympathectomy or lumbar sympathetic neurolysis with phenol 7% in lower limb complex regional pain syndrome type 1. The study end points were pain relief and side effects.
                Within each group, there were statistically significant reductions from baseline in various pain scores after the procedure. However, there was no statistically significant difference in mean pain scores between the groups.
                Based on this pilot study, radiofrequency lumbar sympathectomy may be comparable to phenol lumbar sympathectomy. A larger trial is required to confirm these findings. There are many systematic reviews of continuing education programmes and educational strategies for quality improvement in health care. Most of the reviewed studies are one-off evaluations rather than impact evaluations with long-term follow-up. There are few systematic reviews of organisational, financial and regulatory interventions, and few high-quality studies. These interventions are probably as or more important than educational strategies, although they are less well evaluated. Few studies have been undertaken in low- and middle-income countries (LMIC) or that address maternal and child health (MCH). Thus, the results of the available studies and reviews need to be interpreted cautiously when applied to LMIC. Interactive workshops, reminders and multifaceted interventions can improve professional practice, and they generally have moderate effects. Educational outreach visits consistently improve prescribing but have variable effects on other behaviours. Audit and feedback interventions have variable effects on professional practice, but most often these are small to moderate effects. Mass-media and patient-mediated interventions may change professional practice. Multifaceted interventions that combine several quality-improvement strategies are also effective but may not be more so than single interventions. While all of these strategies are applicable to MCH in LMIC, the applicability of the results to rural settings, in particular, may be limited. Use of these strategies could exacerbate inequalities, and this should be taken into consideration when planning implementation. Scaling up and sustainability may be difficult to achieve in LMIC contexts and need careful consideration. The use of financial interventions has not been well studied; financial incentives and disincentives may be difficult to use effectively and efficiently, although their impact on practice needs to be considered. Organisational interventions are likely to be important, given that there are often underlying organisational or system problems. Regulatory interventions have not been well evaluated, but may sometimes be both inexpensive and effective. There are no 'magic bullets' or simple solutions for ensuring the quality of health care services. Interventions should be selected or tailored to address the underlying reasons for a failure to deliver effective services. Decision-makers should select the most appropriate interventions for specific problems. This requires a governance structure that clearly assigns responsibility for quality-improvement activities, priority setting, selection and design of interventions, and evaluation. There is good evidence of selective outcome reporting in published reports of randomized trials.
                We examined reporting practices for trials of gabapentin funded by Pfizer and Warner-Lambert's subsidiary, Parke-Davis (hereafter referred to as Pfizer and Parke-Davis) for off-label indications (prophylaxis against migraine and treatment of bipolar disorders, neuropathic pain, and nociceptive pain), comparing internal company documents with published reports.
                We identified 20 clinical trials for which internal documents were available from Pfizer and Parke-Davis; of these trials, 12 were reported in publications. For 8 of the 12 reported trials, the primary outcome defined in the published report differed from that described in the protocol. Sources of disagreement included the introduction of a new primary outcome (in the case of 6 trials), failure to distinguish between primary and secondary outcomes (2 trials), relegation of primary outcomes to secondary outcomes (2 trials), and failure to report one or more protocol-defined primary outcomes (5 trials). Trials that presented findings that were not significant (P > or = 0.05) for the protocol-defined primary outcome in the internal documents either were not reported in full or were reported with a changed primary outcome. The primary outcome was changed in the case of 5 of 8 published trials for which statistically significant differences favoring gabapentin were reported. Of the 21 primary outcomes described in the protocols of the published trials, 6 were not reported at all and 4 were reported as secondary outcomes. Of 28 primary outcomes described in the published reports, 12 were newly introduced.
                We identified selective outcome reporting for trials of off-label use of gabapentin. This practice threatens the validity of evidence for the effectiveness of off-label interventions.
                2009 Massachusetts Medical Society Previous research has found that wellness visits, recall and reminder systems, and standing orders are associated with higher rates of delivery of preventive services in primary care practices. However, there is little information about how to help practices implement these processes.
                A 6-month randomized, controlled trial comparing a multicomponent quality improvement intervention to feedback and benchmarking. One clinician/nurse team from each of 24 practices was randomly assigned to one of 2 study arms. Intervention practices received performance feedback, peer-to-peer education (academic detailing), a practice facilitator, and computer (information technology) support. Implementation of the 3 targeted processes was determined by a blinded 3-clinician panel that reviewed transcribed clinician interviews before and after intervention using performance definitions. Rates of delivery of selected preventive services were determined by chart audit.
                Intervention practices implemented more of the processes than control practices overall (P = .003), for adults (P = .05), and for children (P = .04). They were also more likely to implement at least one of the processes for children (P = .04) and to implement standing orders for either children or adults (P = .02). Mammography rates increased significantly. Neither clinician and practice characteristics nor clinician readiness to change predicted implementation.
                A multicomponent implementation strategy consisting of feedback, benchmarking, academic detailing, facilitation, and IT support increased implementation of evidence-based processes for delivering preventive services to a greater extent than performance feedback and benchmarking alone. To evaluate the effects of high thoracic epidural anesthesia (TEA) on global and regional myocardial function and on perioperative coronary risk in patients undergoing coronary artery bypass grafting.
                Prospective and randomized clinical trial blinded for the primary outcome measure of 73 patients scheduled for coronary artery bypass grafting who had a left ventricular ejection fraction of 50% or more conducted from February 1, 2000, through August 31, 2000, at University Hospital, Münster, Germany.
                Of 73 randomized patients, 37 were control subjects (who received general anesthesia only) and 36 were in the group who received general anesthesia and high TEA.
                The primary outcome measure was regional left ventricular function after myocardial revascularization, assessed by transesophageal echocardiography. We further determined the plasma concentrations of cardiac troponin I and atrial and brain natriuretic peptides. Secondary outcome measures were postoperative complications recorded to 14 days and mortality recorded to 720 days.
                High TEA was effective in all patients of this group, the somatosensory block extended from T1 through T7 vertebrae. Regional left ventricular function was significantly improved (mean [SD] global wall motion index, 0.74 [0.18] vs 0.38 [0.16]; P<.05), and cardiac troponin I concentrations were reduced by 72% (mean [SD], 5.7 [1.5] vs 1.6 [0.7] ng/mL, P<.05) in patients with high TEA. Natriuretic peptide concentrations peaked during reperfusion (atrial natriuretic peptide) and 24 hours after reperfusion (brain natriuretic peptide). High TEA reduced the mean (SD) peak concentrations of atrial natriuretic peptide by 54% (211 [63] vs 98 [33] ng/mL, P =.03) and brain natriuretic peptide by 43% (189 [39] vs 108 [21] ng/mL, P =.01). One of 36 patients who received high TEA and 3 of 37 controls died.
                Reversible cardiac sympathectomy by high TEA improves regional left ventricular function and reduces postoperative ischemia after coronary artery bypass grafting. These effects of high TEA may improve the long-term outcome after myocardial revascularization. Randomized controlled trials (RCTs) are accepted as the gold standard for assessing the effectiveness of clinical interventions but are rarely reported in pediatric surgery. Have RCTs submitted to the British Association of Paediatric Surgeons (BAPS) Annual Congress during the last 5 years been adequately designed and large enough to produce a valid result?
                Abstracts accepted by the Annual BAPS Congress meetings between 1996 and 2000 were examined in collaboration with a senior health services researcher. The quality of the design, methodology, statistical analysis and conclusions, and the adequacy of the sample size were assessed for all identifiable clinical RCTs.
                From 760 accepted abstracts, there were only 9 RCTs (1%) of clinical interventions. In only 4 trials was the relevant primary end-point specified at the outset of the study, and none documented the method of randomization. Only one abstract mentioned blinding with respect to the intervention or outcome measure. Sample sizes were inadequate to detect even large clinical differences. To date, only one of these RCTs has been published in an English-language, peer-reviewed journal.
                Clear guidelines exist for the conduct of RCTs, yet compliance with these standards was rarely documented in abstracts of pediatric surgical RCTs presented at BAPS. Sample sizes were inadequate. RCTs in pediatric surgery are difficult to perform, but the specialty would benefit from well-designed, carefully conducted, multicentre, clinical RCTs to advance evidence-based practice.
                Copyright 2003, Elsevier Science (USA). All rights reserved. In complex regional pain syndrome (CRPS) many clinical symptoms suggest involvement of the central nervous system. Neuropathic pain as the leading symptom is often resistant to therapy. In the present study we investigated the analgesic efficiency of repetitive transcranial magnetic simulation (rTMS) applied to the motor cortex contralateral to the CRPS-affected side. Seven out of ten patients reported decreased pain intensities. Pain relief occurred 30 s after stimulation, whereas the maximum effect was found 15 min later. Pain re-intensified increasingly 45 min after rTMS. In contrast, sham rTMS did not alter pain perception. These findings provide evidence that in CRPS I pain perception can be modulated by repetitive motor cortex stimulation. Recent studies have suggested that segmental ablation is the treatment of choice for patients with ingrowing toenails and that the success rate is 96%. This procedure has been common practice among chiropodists for 20 years, usually using phenol in the United Kingdom, and sodium hydroxide in the United States. However, there has been little critical evaluation of the relative merits of the two chemicals, of the period of chemical application, or of the duration of post-operative pain and healing time. We therefore embarked upon a number of controlled prospective studies to examine these questions. A prospective study of 422 procedures for patients with ingrowing toenails (onychocryptosis) shows that good results are achieved by segmental chemical ablation performed by chiropodists in 91% of cases. The average period of post-operative pain is 3.6 days. Similar results are obtained using either 80% phenol or 10% sodium hydroxide. We believe that segmental chemical ablation by a chiropodist is the treatment of choice for the typical patient with an ingrowing toe nail. A double-blind, randomised, placebo-controlled 8-week study was conducted to evaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain, using doses up to 2400 mg/day. The study used a novel design that was symptom- rather than syndrome-based; an approach that aimed to reflect the realities of clinical practice. Participants had a wide range of neuropathic pain syndromes, with at least two of the following symptoms: allodynia, burning pain, shooting pain, or hyperalgesia. Patients were randomised to gabapentin (n=153) or placebo (n=152). Gabapentin was given in three divided doses, initially titrated to 900 mg/day over 3 days, followed by two further increases, to a maximum of 2400 mg/day if required by the end of week 5. The primary outcome measure was changed in average daily pain diary score (baseline versus final week). Over the 8 week study, this score decreased (i.e. improved) by 1.5 (21%) in gabapentin treated patients and by 1.0 (14%) in placebo treated patients (P=0.048, rank-based analysis of covariance). Significant differences were shown in favour of gabapentin (P<0.05) for the Clinician and Patient Global Impression of Change, and some domains of the Short Form-McGill Pain Questionnaire. Improvements were also shown in patient-reported outcomes in quality of life, as seen by significant differences in favour of gabapentin in several domains of the Short-Form-36 Health Survey. Gabapentin was well tolerated and the majority of patients completed the study (79 versus 73% for placebo). The most common adverse events were mild to moderate dizziness and somnolence, most of which were transient and occurred during the titration phase. This study shows that gabapentin reduces pain and improves some quality-of-life measures in patients with a wide range of neuropathic pain syndromes. To examine the use of sex- and gender-based analysis (SGBA) in systematic reviews of cardiovascular health in order to strengthen the evidence base for clinical practice and policy.
                To determine the current status of SGBA in systematic reviews, an appraisal tool was developed by the research team and applied by an independent reviewer to a random sample of 38 Cochrane systematic reviews. The sample was drawn from reviews addressing interventions for cardiovascular diseases (CVD). A random sample of Cochrane reviews in cardiovascular health was selected from the Cochrane Library, Issue 3, 2001, to Issue 3, 2007. The main outcome measure was the number of reviews that included analysis of sex or gender or both.
                Our findings showed that SGBA was generally absent in the sampled reviews. Data were rarely disaggregated by sex; only 2 of 38 reviews reported any sex or gender research gaps. Only one quarter of the reviews included a rationale as to why any subgroup analyses by sex were or were not completed. None of the 38 reviews met all of the appraisal tool criteria. As well, we found that where sex or gender was mentioned, the terms were used interchangeably.
                Despite increasing evidence over the past decade documenting that sex and gender frequently matter in CVD, this study demonstrated that SGBA was rarely considered in systematic reviews. We suggest this omission has important implications for assuring the quality of research and of evidence-based policy and practice and for achieving equitable health outcomes for women and men. To build a robust evidence base for future work in cardiovascular health, we propose that the methodologies of systematic reviews and of SGBA be refined and synchronized to enhance the collection, synthesis, and analysis of evidence for decision making. Assertive community treatment (ACT) has been applied to a number of disorders in the adult population, such as schizophrenia, with some degree of success; its use in the treatment of people with intellectual disability (ID) and mental illness has received little attention. Despite the high costs of ID in health and social care, there has been very little evidence-based practice for people with ID and mental illness, and it remains a neglected area of research. Aims The aims of this study were an exploratory comparison of the effectiveness of an ACT model for the treatment of mental illness in people with ID (ACT-ID) with a standard community treatment (SCT-ID) approach.
                A Randomized controlled trial design was adopted and allocation was made by stratified randomization by an independent statistician. The prognostic factors used in the randomization were gender and psychiatric diagnosis (psychosis vs. affective). Service users were randomly allocated to either ACT-ID or SCT-ID.
                There were no statistically significant differences between ACT-ID and SCT-ID in terms of the level of unmet needs, carer burden, functioning and quality of life, but borderline evidence of a difference between treatment groups in quality of life in favour of SCT-ID. Both SCT-ID and ACT-ID groups decreased level of unmet needs and carer burden, and increased functioning. SCT-ID also led to a small increase in quality of life.
The practice of surgical and chemical sympathectomy for neuropathic pain and CRPS is based on very little high quality evidence. Sympathectomy should be used cautiously in clinical practice, in carefully selected patients, and probably only after failure of other treatment options.