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PubMed2006

Pain relief in early rehabilitation of rotator cuff tendinitis: any role for indirect suprascapular nerve block?

AIM: The purpose of the trial was to evaluate the efficacy of suprascapular nerve block (SSNB) to relieve the shoulder pain, ameliorate recovery after physiotherapy and reduce disability due to a rotator cuff tendinitis (RCT). A prospective, randomized, comparison cross over investigation was performed in the setting of a large inpatient rehabilitation unit with more than 200 admissions annually. METHODS: A total of 40 potential study subjects, who complained of shoulder pain from a RCT, were enrolled and randomly assigned to standard rehabilitation treatment plus SSNB (Group A) or to standard rehabilitation treatment alone (Group B). The UCLA shoulder rating scale was used to assess the shoulder mobility on admission and discharge, and to calculate the percentage of potential improvement achieved during rehabilitation (effectiveness). A pain visual analogic scale was used to serially assess pain. At the end of the trial, a self-report questionnaire evaluated whether patients could sleep and achieve activity of day life carry out everyday activities better than they could before treatment. RESULTS: Forty patients suffering from RCT entered the study. Those receiving nerve block from the beginning of the treatment in addition to standard rehabilitation therapy reported significantly less pain during physiotherapy and better final outcomes. During treatment with SSNBs, patients reported a more significant reduction in the intensity of pain and a better reduction of pain during sleep and rehabilitation exercises in comparison to with the standard therapy alone. A statistically significant inverse correlation was found between shoulder pain and mobility. CONCLUSIONS: The results indicate that combining nerve block with standard rehabilitative therapy may improve the final outcome of painful RCT. It decreased the severity and frequency of the perceived pain, improved the compliance with physiotherapy, restored more normal sleep patterns, and increased compliance with the rehabilitation program. This result proves to be an effective, safe and inexpensive therapeutic option for patients suffering from painful disabling shoulder tendinitis.

Chi-Square Distribution↗
PubMed1991

Shoulder impingement syndrome. A critical review.

Impingement syndrome is an ill-defined term for a variety of disorders of the shoulder that manifest as anterior shoulder pain, especially during overhead activities. These disorders each have a common pathologic course that includes rotator cuff tendinitis (RCT), and, if untreated, may proceed to cuff rupture. RCT has at least two distinct etiologies. Primary impingement of the supraspinatus tendon on the coracoacromial arch is responsible in the majority of nonathletic cases. Overhead movements in sports are prone to developing secondary mechanical impingement because of an instability pattern that is common in this population. Information from this review and clinical practice permits differentiation of the two distinct etiologies of RCT which is important in treatment planning. Much work still needs to be done in defining the microscopic pathology of RCT.

Humans↗
PubMed1987

Clinical evaluation: how does it influence medical practice?

This paper reviews reports of the effects of clinical evaluations on physician awareness and behavior. Among the reviewed papers, there are 28 studies of the effect of specific randomized clinical trials (RCTs) on 19 different medical practices. After analyzing these 28 papers, there remain two (7%) where the RCT has clear implications for practice, where the pattern of practice reported quantitatively over time conforms fully to the RCT findings, where the RCT preceded the change in the pattern of practice, and where findings from the RCT differ from the results of other forms of evaluation. The majority of the reviewed papers do not support an inference that RCTs have a strong, direct influence in changing established clinical practices. Clinical evaluation is one among many factors bearing on changes in medical practices. Improving the care of patients requires both improved methods of evaluation and more effective translation of the results of evaluation into practice. Evaluations are likely to exert a greater impact on medical practices if they are buttressed by attention to other controllable factors, like channels of communication and environmental constraints and incentives, that affect the adoption and abandonment of medical practices.

Awareness↗
PubMed1985

Defect in cholesterol transport in patients receiving maintenance hemodialysis.

A defect in cholesterol transport was detected in patients with uremia who were receiving long-term hemodialysis when the rate of cholesterol transfer (RCT) from high-density lipoprotein (HDL) to very low-density (VLDL) and low-density lipoproteins (LDL) was compared with that in controls. The RCT (mean +/- SD) in 29 men with uremia (1.85 +/- 1.29 mg/hr/100 ml) and 11 women with uremia (1.84 +/- 1.00 mg/hr/100 ml) was significantly lower (P less than 0.001) than values in 55 healthy men (4.50 +/- 2.61 mg/hr/100 ml) and 23 healthy women (3.72 +/- 1.92 mg/hr/100 ml), respectively. Six patients, but none of the controls, totally lacked the ability for cholesterol transfer. The decreased RCT of the patients could not be completely accounted for by their decreased HDL cholesterol levels, because patients matched with controls for HDL cholesterol within 1 mg/100 ml also had lower RCT (P less than 0.0025). Recombination and crossover of serum fractions of patients and controls separated by ultracentrifugation revealed that the defect in cholesterol transfer of the patients was in the d greater than 1.063 gm/ml fraction (containing HDL and other serum proteins), which not only contained less HDL cholesterol, but was also qualitatively inferior as donor for cholesterol transfer. In one of four patients studied, the d less than 1.063 gm/ml fraction (VLDL and LDL) also had deficient ability to accept cholesteryl esters in the transfer. These in vitro data indicate a defect in cholesterol transport in the patients who are undergoing hemodialysis. Whether this defect exists in vivo and creates the risk of accelerated atherosclerosis warrants further study.

Adult↗
PubMed1997

Prediction of bleeding diathesis in patients undergoing cardiopulmonary bypass during cardiac surgery: viscoelastic measures versus routine coagulation test.

BACKGROUND: Severe hemorrhagic tendency often complicates cardiopulmonary bypass (CPB) in cardiac surgery. In this study, we compared the effectiveness of thromboelastography (TEG), Sonoclot (SCT), and routine coagulation test (RCT) in the prediction of coagulation defects. METHODS: Forty-three patients undergoing cardiac surgery with CPB were included. Blood for RCT, TEG, and SCT profiles was sampled before systemic heparinization and after protamine administration. Clinically significant bleeding was defined as chest tube drainage in excess of 100 ml/h for 3 consecutive hours or 300 ml/h in 1 h. All coagulation parameters obtained before and after CPB were compared. The sensitivity, specificity, accuracy, false positive, and false negative rate were also calculated and compared. RESULTS: All coagulation tests were within normal range except higher partial thromboplastin time. Variables which were significantly different from those before CPB included platelet count, fibrinogen level, prothrombin time, and thrombin time in RCT, alpha angle and maximum amplitude in TEG, and R2 and peak time in SCT. In the TEG tracing, all variables had high sensitivity, specificity, and accuracy (average 85.4%, 83%, and 83.5% respectively) and low false positive and negative rate (12.5% and 5% respectively). Although SCT had high sensitivity (76.3%) and low false negative rate (6.5%), its specificity and accuracy were all under 50%. CONCLUSIONS: Our data demonstrated that the TEG monitoring is a useful tool for detecting post-CPB bleeding diathesis and can provide much predictive information. RCT and SCT are of limited value because of higher rate of unreliable results.

Blood Coagulation Tests↗
PubMed1999

Randomized clinical trials and longitudinal observational studies in systemic lupus erythematosus: consensus on a preliminary core set of outcome domains.

The OMERACT module on systemic lupus erythematosus (SLE) dealt with the definition of preliminary core sets of outcome domains for randomized clinical trials (RCT) and longitudinal observational studies (LOS). After lectures introducing the problems and addressing the key issues, 6 discussion groups, 3 each for LOS and RCT, discussed and weighted more than a dozen possible items for use as outcome domains. The means of the respective 3 groups were calculated. For both RCT and LOS the same outcome domains received more than 10 of a total maximum of 100 points: disease activity, health related quality of life (HRQOL), damage, and toxicity/adverse events. However, the weights for HRQOL and damage were different for LOS and RCT. A final vote led to the acceptance of these 4 variables as a preliminary core set for outcome in SLE by more than 80% of the participants. This core set will allow for improved design, performance, and evaluation of future studies in SLE. However, a number of domains not included in the core set were regarded as important for further analysis and research.

Decision Making↗
PubMed2006

Effectiveness of nonpharmacological interventions for the management of neuropsychiatric symptoms in patients with dementia: a systematic review.

BACKGROUND: Recent reports documenting limited evidence supporting the use of pharmacological interventions for neuropsychiatric symptoms (NPS) and increased risk of death, the black box warnings against the use of atypical antipsychotic drugs in older adults, and Omnibus Budget Reconciliation Act regulations suggest the need to evaluate the usefulness of nonpharmacological interventions in the management of NPS of dementia. METHODS: To determine the evidence base of nonpharmacological interventions for the management of NPS in patients with dementia, we reviewed MEDLINE, PsycINFO, the Cochrane library, and relevant bibliographies published from January 1966 to December 2005, using the American Psychological Association Guidelines. RESULTS: Three randomized controlled trials (RCTs) and 6 single-case designs (SCDs; N of 1 trials) met inclusion criteria. Under unmet needs interventions, 1 SCD found a moderate reduction in problem behaviors. Under behavioral interventions, based on observational data, all 4 SCDs reported a relative reduction of 50% to 100% in neuropsychiatric symptoms. Under caregiving interventions, there were 3 RCTs. At the 6-month follow-up, 1 RCT found a reduction in 4 neuropsychiatric symptom subscales: ideation disturbance score (0.3 vs 0.5; range, 0-8; P = .005); irritability score (18.8 vs 23.0; range, 8-38; P = .008); verbal agitation, as measured by mean frequency of 20-minute outbursts (0.5 vs 0.8; P = .005); and physical aggression score (11.4 vs 12.9; range, 6-42; P<.001). Another RCT found a significant improvement in frequency (2.3 vs 3.1; range, 0-4; P<.001) and severity (2.2 vs 2.8; range, 0-4; P<.001) of target behaviors associated with the intervention arm. The third RCT found no effect. Under bright light therapy, 1 SCD found short-term improvements on the Agitated Behavior Rating Scale (9.7 vs 19.9; P<.001). CONCLUSIONS: The cumulative research to date on the impact of nonpharmacologic interventions for NPS among patients with dementia indicates that interventions that address behavioral issues and unmet needs and that include caregivers or bright light therapy may be efficacious. More high-quality research is necessary to confirm these findings.

Behavior Therapy↗
PubMed2007

External validity of clinical trials in acute myocardial infarction.

BACKGROUND: Patients enrolled in randomized clinical trials (RCTs) may not reflect those seen in real-life practice. Our goal was to compare patients eligible for enrollment but not enrolled in contemporary RCTs of reperfusion therapy with patients who would have been ineligible and also with patients with acute myocardial infarction (AMI) participating in RCTs. METHODS: Consecutive patients with AMI (n = 8469) enrolled in the GRACE registry (Global Registry of Acute Coronary Events) were divided into 3 groups: RCT participants (11%; n = 953), eligible nonenrolled patients (55%; n = 4669), and ineligible patients (34%; n = 2847). Our main outcome measures were hospital mortality rates. RESULTS: Based on baseline characteristics or GRACE risk-score distribution, RCT participants had the lowest a priori risk of death; eligible patients had a higher risk; and ineligible patients had the highest risk. Actual hospital mortality showed a similar gradient (3.6%, 7.1%, and 11.4%, respectively) (P<.001). Multivariable analysis adjusting for baseline risk, use and type of reperfusion therapy, and delay from symptom onset to admission consistently showed a higher mortality rate for eligible nonenrolled patients than for RCT participants (odds ratio, 1.61; 95% confidence interval, 1.06-2.43; and odds ratio, 1.97; 95% confidence interval, 1.24-3.13, respectively). CONCLUSIONS: Patients with AMI participating in RCTs have a lower baseline risk and experience lower mortality than nonenrolled patients, even when they are trial eligible. This difference is not entirely explained by differences in baseline risk, use and type of reperfusion therapy, and/or delays in presentation. Caution is necessary when extending the findings obtained in RCTs to the general population with AMI.

Aged↗
PubMed2002

Randomized controlled trials for evaluating surgical questions.

OBJECTIVE: To discuss some of the obstacles inherent in the design of the randomized controlled trial (RCT) that the surgeon must confront and options to minimize these obstacles. DATA SOURCES: The literature was searched for articles discussing RCTs using MEDLINE from 1966 to 1998. STUDY SELECTION: Studies relevant to the general use of RCTs for evaluating surgical questions were selected. SYNTHESIS: Several problems inherent in RCTs were noted: (1) ethical considerations, (2) difficulties in patient accrual, (3) patient preferences, and (4) variability in surgical proficiency/technique. Some means of minimizing these problems are (1) the concept of clinical equipoise, (2) multicenter trials, and (3) stratified sampling of patients. Alternatives to the classic RCT are discussed, namely, the randomized consent design and the patient preference design. CONCLUSIONS: The nature of the RCTs is that they are difficult to use to evaluate surgical techniques. Some options are available to minimize these difficulties. Designing and conducting RCTs to evaluate surgical interventions require careful planning and some compromises. Unless the previously mentioned criteria are applied, the validity of the RCT can be considered no greater than that of other trials.

Ethics, Medical↗
PubMed2001

The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials.

To comprehend the results of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this article incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Comment. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from 4 stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, according to each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Publishing↗
PubMed2026

Cognitive Behavior vs Bright Light Therapy for Insomnia in Women Undergoing Chemotherapy for Breast Cancer: A Randomized Clinical Trial.

IMPORTANCE: Women receiving chemotherapy for breast cancer experience insomnia and fatigue, which impair quality of life. To date, no randomized clinical trial (RCT) has evaluated the use of cognitive behavior therapy for insomnia (CBT-I) and bright light therapy (BLT) both alone and in combination, and few have evaluated the use of either during chemotherapy. OBJECTIVE: To determine the main effects of CBT-I and BLT on insomnia and fatigue symptoms in women undergoing chemotherapy for breast cancer. DESIGN, SETTING, AND PARTICIPANTS: Sleep, Cancer, Rest (SleepCARE) was a 6-week, 2&#x2009;&#xd7;&#x2009;2 factorial, superiority, parallel RCT conducted at 5 metropolitan and regional hospitals in Australia from January 22, 2021, to August 21, 2024. Participants were women (aged &#x2265;18 years) receiving chemotherapy for early or metastatic breast cancer. INTERVENTIONS: Two brief interventions were administered: CBT-I and BLT alone (using light glasses at 1500 lux) and in combination, creating 4 groups (CBT-I alone, BLT alone, CBT-I plus BLT, and sleep hygiene education [SHE]). All interventions included SHE. The interventions lasted 6 weeks and included a 1:1 consultation session, emails sent once or twice per week, and a midpoint call for all groups, as well as light glasses for the BLT groups. MAIN OUTCOMES AND MEASURES: Dual primary outcomes were Insomnia Severity Index (ISI) scores and Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue T scores. Both are patient-reported outcome measures and measure insomnia and fatigue symptoms, respectively. Assessments occurred via surveys administered at baseline and at the midpoint (3 weeks), postintervention (6 weeks), and follow-up (3 months and 6 months) periods. Modified intention-to-treat analyses used latent growth models. RESULTS: Of the 219 women enrolled (mean [SD] age, 50.7 [10.8] years; 54 [26.9%] with metastatic cancer), 55 were randomized to CBT-I, 55 to BLT, 52 to CBT-I plus BLT, and 57 to SHE. A total of 208 women (95.0%) with any data at any time point were analyzed. Insomnia symptoms (ISI score mean difference [MD], -2.19 [95% CI, -3.33 to -1.05] points; P&#x2009;=&#x2009;.002) but not fatigue symptoms (PROMIS-Fatigue score MD, -0.90 [95% CI, -3.08 to 1.28] points; P&#x2009;=&#x2009;.52) improved more in the CBT-I groups compared with the non-CBT-I groups. The BLT groups (compared with the non-BLT groups) did not differ in insomnia symptoms (ISI score MD, -0.88 [95% CI, -2.02 to 0.26] points; P&#x2009;=&#x2009;.26) or fatigue symptoms (PROMIS-Fatigue score MD, -0.71 [95% CI, -2.89 to 1.47] points; P&#x2009;=&#x2009;.52). Comparable results emerged in the high-adherence subgroup and in the subgroups with high initial insomnia and fatigue symptoms. However, exploratory subgroup analyses in women with metastatic breast cancer showed that BLT (vs non-BLT) improved insomnia symptoms (ISI score MD, -2.87 [95% CI, -5.06 to -0.67] points; P&#x2009;=&#x2009;.01) and fatigue symptoms (PROMIS-Fatigue score MD, -5.16 [95% CI, -9.57 to -0.76] points; P&#x2009;=&#x2009;.02). CONCLUSIONS AND RELEVANCE: In the SleepCARE RCT of CBT-I and BLT administered for 6 weeks to women receiving chemotherapy for breast cancer, CBT-I improved insomnia but not fatigue compared with SHE or BLT. BLT did not produce greater improvements in fatigue or insomnia symptoms compared with non-BLT treatment. The study findings indicate that brief CBT-I, but not BLT, may reduce insomnia symptoms among women receiving chemotherapy for breast cancer. TRIAL REGISTRATION: ANZCTR Identifier: ACTRN12620001133921.

Humans↗
PubMedDate not supplied

Esophageal cancer surgery: the value of controlled clinical trials.

Prospective randomized controlled trials (RCT) in esophageal cancer were reviewed. Their value and significance in the areas of multimodality therapy, lymphadenectomy, surgical techniques, palliative treatments, and perioperative management were evaluated. Much has been gained through RCT in the management of esophageal cancer, and RCT is the most reliable scientific method in clinical investigations. Problems in the conduct of such trials include lack of expertise by surgeons, lack of patients, lack of funding, and methodologic and ethical problems. These obstacles could be overcome and more well-conducted RCTs encouraged.

Adenocarcinoma↗
PubMed2000

Screening for lung cancer: do we need randomized trials?

In a scientifically ideal randomized controlled trial (RCT) on the efficacy of screening for lung cancer, screening-detected cases would be allocated to immediate intervention or to no action until symptoms lead to diagnostics. The study would provide for learning about the extent to which earlier interventions (defined by disease stage and stage-conditional tumor size) enhance curability, and also about the distributions of disease stage and stage-conditional tumor size at the time of diagnosis under the particular regimen of screening and its associated diagnostics. Because ethics call for randomization to screening or no screening, this contrast no longer provides for studying the curability function of shared concern for all regimens of screening; it addresses only the overall curability advantage specific to the regimen deployed. The same information that is provided by the scientifically ideal RCT is obtainable from a noncomparative study in which each member of the study cohort is subject to both screening and early intervention, so long as the problem of "overdiagnosis" is avoided by documenting growth before biopsy for cytologic or histologic criteria of malignancy and so long as the outcome of intervention is documented by follow-up. The ethically feasible RCT, in addition to compromising the objects of study, involves validity problems of its own and is less efficient by an order of magnitude.

Humans↗
PubMed2000

Using health production functions to evaluate treatment effectiveness: an application to a community mental health service.

The randomized controlled trial (RCT) is the recommended means of evaluating health care effectiveness and cost-effectiveness. Whilst representing a 'gold-standard' in health services research, RCT evidence on the clinical and economic desirability of services and treatments is often absent. Where RCT evidence is lacking, or where it is infeasible to implement randomized controlled comparisons, longitudinal observational and naturalistic data sources when analysed appropriately can yield useful insights regarding the clinical effectiveness and economic efficiency of treatments. In this paper we demonstrate the utility of applying panel estimation methods to data from an Italian psychiatric case register as a means of modelling the mental health outcomes of patients referred to a community-based mental health service. Emphasis is placed on quantifying the clinical effectiveness of consultations with different mental health professionals (including in-patient days) and whether service outcomes are affected by psychiatric diagnosis. The impact of service consultations and their interaction with different types of psychiatric diagnosis on a measure of patient mental health are found to be statistically significant, although the size of these effects are not substantial from a clinical perspective.

Adult↗
PubMed2005

Electroconvulsive therapy for schizophrenia.

BACKGROUND: Electroconvulsive therapy (ECT) involves the induction of a seizure for therapeutic purposes by the administration of a variable frequency electrical stimulus shock via electrodes applied to the scalp. The effects of its use in people with schizophrenia are unclear. OBJECTIVES: To determine whether electroconvulsive therapy (ECT) results in clinically meaningful benefit with regard to global improvement, hospitalisation, changes in mental state, behaviour and functioning for people with schizophrenia, and to determine whether variations in the practical administration of ECT influences outcome. SEARCH STRATEGY: We undertook electronic searches of Biological Abstracts (1982-1996), EMBASE (1980-1996), MEDLINE (1966-2004), PsycLIT (1974-1996),SCISEARCH (1996) and the Cochrane Schizophrenia Group's Register (July 2004). We also inspected the references of all identified studies and contacted relevant authors. SELECTION CRITERIA: We included all randomised controlled clinical trials that compared ECT with placebo, 'sham ECT', non-pharmacological interventions and antipsychotics and different schedules and methods of administration of ECT for people with schizophrenia, schizoaffective disorder or chronic mental disorder. DATA COLLECTION AND ANALYSIS: Working independently, we selected and critically appraised studies, extracted data and analysed on an intention-to-treat basis. Where possible and appropriate we calculated risk ratios (RR) and their 95% confidence intervals (CI) with the number needed to treat (NNT). For continuous data Weighted Mean Differences (WMD) were calculated. We presented scale data for only those tools that had attained pre-specified levels of quality. We also undertook tests for heterogeneity and publication bias. MAIN RESULTS: This review includes 26 trials with 50 reports. When ECT is compared with placebo or sham ECT, more people improved in the real ECT group (n=392, 10 RCTs, RR 0.76 random CI 0.59 to 0.98, NNT 6 CI 4 to 12) and though data were heterogeneous (chi-square 17.49 df=9 P=0.04), its impact on variability of data was not substantial (I-squared 48.5%). There was a suggestion that ECT resulted in less relapses in the short term than sham ECT (n=47, 2 RCTs, RR fixed 0.26 CI 0.03 to 2.2), and a greater likelihood of being discharged from hospital (n=98, 1 RCT, RR fixed 0.59, CI 0.34 to 1.01). There is no evidence that this early advantage for ECT is maintained over the medium to long term. People treated with ECT did not drop out of treatment earlier than those treated with sham ECT (n=495, 14 RCTs, RR fixed 0.71 CI 0.33 to 1.52, I-squared 0%). Very limited data indicated that visual memory might decline after ECT compared with sham ECT (n=24, 1 RCT, WMD -14.0 CI -23 to -5); the results of verbal memory tests were equivocal. When ECT is directly compared with antipsychotic drug treatments (total n=443, 10 RCTs) results favour the medication group (n=175, 3 RCTs, RR fixed 'not improved at the end of ECT course' 2.18 CI 1.31 to 3.63). Limited evidence suggests that ECT combined with antipsychotic drugs results in greater improvement in mental state (n= 40, 1 RCT, WMD, Brief Psychiatric Rating Scale -3.9 CI - 2.28 to -5.52) than with antipsychotic drugs alone. One small study suggested more memory impairment after a course of ECT combined with antipsychotics than with antipsychotics alone (n=20, MD serial numbers and picture recall -4.90 CI -0.78 to -9.02), though this proved transient. When continuation ECT was added to antipsychotic drugs, the combination was superior to the use of antipsychotics alone (n=30, WMD Global Assessment of Functioning 19.06 CI 9.65 to 28.47), or CECT alone (n=30, WMD -20.30 CI -11.48 to -29.12). Unilateral and bilateral ECT were equally effective in terms of global improvement (n=78, 2 RCTs, RR fixed 'not improved at end of course of ECT' 0.79 CI 0.45 to 1.39). One trial showed a significant advantage for 20 treatments over 12 treatments for numbers globally improved at the end of the ECT course (n=43, RR fixed 2.53 CI 1.13 to 5.66). AUTHORS' CONCLUSIONS: The evidence in this review suggests that ECT, combined with treatment with antipsychotic drugs, may be considered an option for people with schizophrenia, particularly when rapid global improvement and reduction of symptoms is desired. This is also the case for those with schizophrenia who show limited response to medication alone. Even though this initial beneficial effect may not last beyond the short term, there is no clear evidence to refute its use for people with schizophrenia. The research base for the use of ECT in people with schizophrenia continues to expand, but even after more than five decades of clinical use, there remain many unanswered questions regarding its role in the management of people with schizophrenia.

Electroconvulsive Therapy↗
PubMed2004

Zuclopenthixol acetate for acute schizophrenia and similar serious mental illnesses.

BACKGROUND: Medication used for acute aggression in psychiatry must have rapid onset of effect, low frequency of administration and low levels of adverse effects. Zuclopenthixol acetate is said to have these properties. OBJECTIVES: To estimate the clinical effects of zuclopenthixol acetate for the management of acute aggression or violence thought to be due to serious mental illnesses, in comparison to other drugs used to treat similar conditions. SEARCH STRATEGY: We supplemented past searches of Current Controlled Trials (10/2000), the Cochrane Library (1997) and MEDLINE (1966-1997) and appeals for unpublished data with an update search of the Cochrane Schizophrenia Group's Register of trials (September 2003). SELECTION CRITERIA: All randomised clinical trials involving people thought to have serious mental illnesses comparing zuclopenthixol acetate with other drugs. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers and cross-checked. We calculated fixed effects relative risks (RR) and 95% confidence intervals (CI) for dichotomous data. Where possible, the number needed to treat/harm statistic (NNT/H) was calculated. We analyzed by intention-to-treat. Mean differences were used for continuous variables. MAIN RESULTS: We found no data for the primary outcome, tranquilisation. Compared with haloperidol, zuclopenthixol acetate was no more sedating at two hours (n=40, 1 RCT, RR 0.60 CI 0.27 to 1.34). People given zuclopenthixol acetate were not at reduced risk of being given supplementary antipsychotics (n=134, 3 RCTs, RR 1.49 CI 0.97 to 2.30) although additional use of benzodiazepines was less (n=50, 1 RCT, RR 0.03 CI 0.00 to 0.47, NNT 2 CI 2 to 4). People given zuclopenthixol acetate had fewer injections over seven days compared with those allocated to haloperidol IM (n=70, 1 RCT, RR 0.39 CI 0.18 to 0.84, NNT 4 CI 3 to 14). We found no data on more episodes of aggression or harm to self or others. One trial (n=148) reported no significant difference in adverse effects for people receiving zuclopenthixol acetate compared with those allocated haloperidol at one, three and six days (RR 0.74 CI 0.43 to 1.27). Compared with haloperidol or clotiapine, people allocated zuclopenthixol did not seem to be at more risk of a range of movement disorders (<20%). Three studies found no difference in the proportion of people getting blurred vision/ dry mouth (n=192, 2 RCTs, RR at 24 hours 0.90 CI 0.48 to 1.70). Similarly dizziness was equally infrequent for those allocated zuclopenthixol acetate compared with haloperidol (n=192, 2 RCTs, RR at 24 hours 1.15 CI 0.46 to 2.88). There was no difference between treatments for leaving the study before completion (n=522, RR 0.85 CI 0.31 to 2.31). REVIEWERS' CONCLUSIONS: Recommendations on the use of zuclopenthixol acetate for the management of psychiatric emergencies in preference to 'standard' treatment have to be viewed with caution. Most trials present important methodological flaws and findings are poorly reported. This review did not find any suggestion that zuclopenthixol acetate is more or less effective in controlling aggressive acute psychosis, or in preventing adverse effects than intramuscular haloperidol, and neither seemed to have a rapid onset of action. Well-conducted pragmatic randomised controlled trials are needed.

Acute Disease↗
PubMed2001

Patient education for preventing diabetic foot ulceration.

BACKGROUND: Ulceration of the feet, which can result in loss of limbs and even death, is one of the major health problems for people with diabetes mellitus. OBJECTIVES: To assess the effectiveness of patient education on the prevention of foot ulcers in patients with diabetes mellitus. SEARCH STRATEGY: Eligible studies were identified by searching the Wounds Group Specialised Trials Register, which is compiled from regular searches of the major health care databases including MEDLINE, Cinahl and EMBASE, hand searching of wound care journals and relevant conference proceedings. For this review the Register was searched up to March 2001. SELECTION CRITERIA: Prospective randomised controlled trials (RCTs) which evaluated educational programmes for the prevention of foot ulcers in people with diabetes mellitus. There was no restriction on language of the publications. DATA COLLECTION AND ANALYSIS: Data extraction and assessment of study quality were undertaken by two reviewers independently. MAIN RESULTS: The methodological quality of the 8 included RCTs was poor. The internal validity score (range 0 - 10) of individual RCTs ranged from 2 to 4. Four trials compared the effect of intensive with brief educational interventions; 2 of these reported clinical endpoints. One study involving high-risk patients reported a reduction in ulcer incidence (Peto OR: 0.28 (95% CI 0.13,0.59)) and amputation rate (Peto OR: 0.32 (0.14,0.71)) after 1 year. The other RCT did not find an effect at seven years follow-up. Participants' foot care knowledge significantly improved with education in 2 trials. In one trial, foot care knowledge was significantly worse at 6 months, although foot care behaviour improved significantly. Non-calcaneal callus was significantly reduced by education in one trial. One RCT did not find that patient foot care education, as part of a general diabetes education program reduced foot ulceration compared with usual care. Patient education as part of a complex intervention targeted at both people with diabetes and doctors reduced the number of serious foot lesions at one year, in one RCT (OR: 0.41(0.16-1.00)) and improved foot care behaviour. Evidence from 2 RCTs comparing the effect of patient-tailored education in addition to usual care was conflicting. REVIEWER'S CONCLUSIONS: RCTs evaluating education for people with diabetes, aimed at preventing diabetic foot ulceration, are mostly of poor methodological quality. Existing data suggests that patient education may reduce foot ulceration and amputations, especially in high-risk patients. Foot care knowledge and behaviour of patients seem positively influenced by patient education in the short term. Because of conflicting results and the methodological shortcomings more RCTs are needed.

Diabetic Foot↗
PubMed2005

Patient education for preventing diabetic foot ulceration.

BACKGROUND: Ulceration of the feet, which can result in loss of limbs and even death, is one of the major health problems for people with diabetes mellitus. OBJECTIVES: To assess the effectiveness of patient education on the prevention of foot ulcers in patients with diabetes mellitus. SEARCH STRATEGY: Eligible studies were identified by searching the Cochrane Wounds Group Specialised Register, (September 2004) and the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3, 2004). SELECTION CRITERIA: Prospective randomised controlled trials (RCTs) which evaluated educational programmes for the prevention of foot ulcers in people with diabetes mellitus. There was no restriction on language of the publications. DATA COLLECTION AND ANALYSIS: Two reviewers undertook data extraction and assessment of study quality independently. MAIN RESULTS: Nine RCTs were included. Four trials compared the effect of intensive with brief educational interventions; two of these reported clinical endpoints. One study involving high-risk patients reported a reduction in ulcer incidence (Peto OR: 0.28 (95% CI 0.13 - 0.59)) and amputation rate (Peto OR: 0.32 (95% CI 0.14 - 0.71)) after one year. The other RCT did not find an effect at seven years follow-up. Participants' foot care knowledge significantly improved with education in two trials. In one trial foot care knowledge improved significantly in the control group, in contrast to the intervention group. Non-calcaneal callus was significantly reduced by education in one trial. One RCT did not find that patient foot care education, as part of a general diabetes education program, reduced foot ulceration compared with usual care. Patient education as part of a complex intervention, targeted at both people with diabetes and doctors, reduced the number of serious foot lesions at one year in one RCT (OR: 0.41(95% CI 0.16 -1.00)) and improved foot care behaviour. Evidence from three RCTs comparing the effect of patient-tailored education in addition to usual care was conflicting.The methodological quality of the nine included RCTs was poor. The internal validity score (range 0 - 10) of individual RCTs ranged from 2 to 5. AUTHORS' CONCLUSIONS: RCTs evaluating education for people with diabetes, aimed at preventing diabetic foot ulceration, are mostly of poor methodological quality. Weak evidence suggests that patient education may reduce foot ulceration and amputations, especially in high-risk patients. Foot care knowledge and behaviour of patients seem positively influenced by patient education in the short term. Because of conflicting results and the methodological shortcomings more RCTs are needed.

Diabetic Foot↗