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PubMed1990

Is routine vitamin E administration justified in very low-birthweight infants?

Analysis of nine randomised controlled trials of prophylactic vitamin E supplementation in very low-birthweight infants (less than 1500g) showed no statistically significant reduction in the incidence of acute retinopathy of prematurity. There was a significant reduction (49 per cent) in the incidence of intraventricular haemorrhage, but no clear evidence for a corresponding reduction in intracerebral haemorrhage and no reduction in the incidence of haemorrhage confined to the germinal matrix. By combining the estimated reduction with the known incidence of long-term neurological disability associated with intracranial haemorrhage alone, it was shown that only 1.5 per cent (point estimate) and not more than about 4 per cent of all very low-birthweight infants are likely to benefit from routine vitamin E supplementation. In view of this, and data suggesting toxicity of vitamin E at concentrations close to those considered therapeutic, the routine use of vitamin E in very low-birthweight infants is not justified on present evidence. Only large randomised trials can establish whether currently used vitamin E preparations do more good than harm.

Cerebral Hemorrhage↗
PubMed2001

Telephone counselling for smoking cessation.

BACKGROUND: Telephone services can provide information and support for smokers. Counselling may be provided proactively or offered reactively to callers to smoking cessation helplines. OBJECTIVES: To evaluate the effect of proactive and reactive telephone support to help smokers quit. SEARCH STRATEGY: We searched the Cochrane Tobacco Addiction Group trials register for studies using free text term 'telephone*' or the keywords 'telephone counselling' or 'Hotlines' or 'Telephone'. Date of the most recent search: August 2000. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials in which proactive or reactive telephone counselling to assist smoking cessation was offered to smokers or recent quitters. DATA COLLECTION AND ANALYSIS: Trials were identified and data extracted by one person and checked by a second. The main outcome measure was abstinence from smoking after at least six months follow-up. We used the most rigorous definition of abstinence in each trial, and biochemically validated rates where available. Participants lost to follow-up were considered to be continuing smokers. Where interventions were similar, we performed meta-analysis using a fixed effects model to give an odds ratio. MAIN RESULTS: Twenty three trials met inclusion criteria. Ten trials compared proactive counselling to a minimal intervention control. There was statistical heterogeneity, with three trials showing a significant benefit, and seven showing non significant differences. Four trials adding telephone support to a face to face intervention control failed to detect a significant effect on long term quit rates. Four trials failed to detect an additional effect of telephone support in users of nicotine replacement therapy. Providing access to a hotline showed a significant benefit in one trial and no significant difference in two. Varying the type of counselling provided has not been shown to affect outcome. REVIEWER'S CONCLUSIONS: Proactive telephone counselling can be effective compared to an intervention without personal contact. There was heterogeneity between trials so the size of effect is uncertain. The available evidence neither confirms nor rules out a benefit of telephone counselling as an adjunct to face to face counselling or pharmacotherapy. Further trials randomising access to helplines are unlikely to be done but indirect evidence suggests they can be a useful part of a smoking cessation service.

Counseling↗
PubMed2003

Depot risperidone for schizophrenia.

BACKGROUND: Risperidone is the first new generation antipsychotic drug made available in a long acting injection. OBJECTIVES: To examine the clinical effects of depot risperidone for people with schizophrenia and schizophrenia-like psychoses. SEARCH STRATEGY: We searched the Cochrane Schizophrenia Group's Register (December 2002), references of all included studies, and contacted industry and authors of included studies. SELECTION CRITERIA: Randomised clinical trials comparing depot risperidone with other treatments for people with schizophrenia and/or schizophrenia-like psychoses. DATA COLLECTION AND ANALYSIS: Two reviewers independently inspected citations and/or abstracts, ordered papers, re-inspected and quality assessed the results, and extracted data. For dichotomous data, we calculated the relative risk (RR), the 95% confidence interval (CI) and, where appropriate, the number needed to treat (NNT), on an intention-to-treat basis. For continuous data, we calculated weighted mean differences (WMD). MAIN RESULTS: One study (n=400) compared depot risperidone with placebo but 56% of people did not complete the three-month study rendering most global and mental state data unusable. Risperidone depot compared with placebo did not affect levels of anxiety (n=400, RR 0.58 CI 0.32 to 1.05) but may decrease agitation (n=400, RR 0.60 CI 0.39 to 0.92). Risperidone depot did not substantially influence hallucinations (n=400, RR 1.23 CI 0.47 to 3.22) but 'psychosis' was reduced (n=400, RR 0.52 CI 0.33 to 0.83, NNT 9 CI 7 to 26). Attrition was higher for the placebo group compared with people allocated risperidone depot (n=400, RR 0.74 CI 0.63 to 0.88, NNT 6 CI 4 to 12). Severe adverse events were common (13% to 23%) but significantly more so in the placebo group (n=400, RR 0.59 CI 0.38 to 0.93, NNT 11 CI 7 to 70). Poor reporting, however, makes these difficult to interpret. Movement disorders were equally common in both groups (n=400, RR 2.38 CI 0.73 to 7.78) although it looks as if there is a trend for the higher depot doses to encourage movement disorders. One study (n=640) compared depot risperidone against oral risperidone for stable people with relatively mild illness. For global outcomes there was no clear difference between the depot group and oral group (n=640, RR 'no global improvement' 1.06 CI 0.92 to 1.22). Mental state measures were also similar across groups. Overall, in this study compliance was good (n=640, RR <4 injections or "major protocol violation" 1.16 CI 0.81 to 1.67). Adverse effects were poorly reported but over half of both groups reported some adverse effect (n=640, RR 1.04 CI 0.91 to 1.18). REVIEWER'S CONCLUSIONS: There is no reliable data to support the claim that depot risperidone is beneficial for people with schizophrenia. For reasonably well, stable people it may mean that the need for regular oral doses can be avoided, but adverse affects are not well reported. For more severely ill people, few benefits are evident although it may increase compliance with injections in comparison with placebo. Use of depot risperidone, especially at the higher doses, is weakly associated with movement disorders. Well designed and reported, randomised studies, firmly grounded in real world clinical practice are needed to fully assess the effects of this new preparation.

Antipsychotic Agents↗
PubMed2005

Randomised studies in general practice: how to integrate the electronic patient record.

The 'randomised database study' strategy was first proposed in 1997, with the aim of combining the generalisability of observational database studies based on electronic patient records (EPRs) with the validity of randomised clinical trials (RCTs). The key feature was to randomly assign treatments and to use routine care data, as available in the observational database, for patient identification and follow-up. To our knowledge, however, the idea of the randomised database study has not been implemented yet. The conduct of a randomised study in an observational database requires adjustments to methods of medical information processing in the general practice. We developed a software system that facilitates the conduct of an RCT with observational databases based on EPRs. It identifies eligible subjects and presents them one by one to the physician once their EPR is accessed. The general practitioner can then start an interactive recruitment process; after completion, the computer randomises the patients. Follow-up is documented by normal routine care in the EPR. Although the randomised database study has many methodological advantages, it has never been tested. Our software system is meant as a tool to implement and facilitate evaluation of the randomised database approach.

Data Collection↗
PubMed2000

Antifibrinolytics for heavy menstrual bleeding.

BACKGROUND: Heavy menstrual bleeding (HMB) is an important cause of ill health in women. Medical therapy, with the avoidance of possibly unnecessary surgery, is an attractive treatment option. A wide variety of medications are available to reduce heavy menstrual bleeding but there is considerable variation in practice and uncertainty about the most appropriate therapy. Plasminogen activators are a group of enzymes that cause fibrinolysis (the dissolution of clots). An increase in the levels of plasminogen activators has been found in the endometrium of women with heavy menstrual bleeding compared to those with normal menstrual loss. Plasminogen activator inhibitors (antifibrinolytic agents) have therefore been promoted as a treatment for heavy menstrual bleeding. There has been a reluctance to prescribe tranexamic acid due to possible side effects of the drugs such as an increased risk of thrombogenic disease (deep venous thrombosis). Long term studies in Sweden, however, have shown that the rate of incidence of thrombosis in women treated with tranexamic acid is comparable with the spontaneous frequency of thrombosis in women. OBJECTIVES: To determine the effectiveness of antifibrinolytics in achieving a reduction in heavy menstrual bleeding. SEARCH STRATEGY: All studies which might describe randomised controlled trials of antifibrinolytic therapy for the treatment of heavy menstrual bleeding were obtained by electronic searches of the MEDLINE 1966-1997, EMBASE 1980-1997 and the Cochrane Library. Companies producing antifibrinolytics and experts within the field were contacted for reference lists and information on unpublished trials. SELECTION CRITERIA: Randomised controlled trials in women of reproductive age treated with antifibrinolytic agents versus placebo, no treatment or any other medical (non-surgical) therapy for regular heavy menstrual bleeding within either the primary, family planning or specialist clinic settings. Women with post menopausal bleeding, intermenstrual bleeding, iatrogenic or pathological causes of heavy menstrual bleeding were excluded. DATA COLLECTION AND ANALYSIS: Fifteen eligible trials were assessed by three reviewers and eight of these did not meet with the inclusion criteria. Of the seven remaining trials, four of these could be included within the meta-analysis. The remaining three trials had a crossover design and despite contacting the authors and appropriate companies, we were unable to extract the results in a format suitable to include these within the meta-analysis. However the results are included within the text of the review for discussion. MAIN RESULTS: Antifibrinolytic therapy compared to placebo showed a significant reduction in mean blood loss (WMD -94.0 [-151.4, -36.5]) and significant change in mean reduction of blood loss (WMD -110.2 [-146. 5, -73.8]). This objective improvement was not mirrored by a patient perceived improvement in monthly menstrual blood loss (RR 2.5 [0.9, 7.3]) in the one study which recorded this outcome ( approximately approximately Edlund 1995 approximately approximately ). Antifibrinolytic agents were compared to only three other medical (non-surgical) therapies: mefenamic acid, norethisterone administered in the luteal phase and ethamsylate. In all instances, there was a significant reduction in mean blood loss (WMD -73.0 [-123.4, -22.6], WMD -111.0 [-178.5, -43.5] and (WMD -100 [-143.9, -56.1] respectively) and a strong, although non-significant trend in favour of tranexamic acid in the participants' perception of an improvement in menstrual blood loss. There were no significant differences in the frequency of reported gastrointestinal side effects with tranexamic acid when compared to either NSAIDs (RR 0.9 [0.4, 2.1], oral luteal phase progestagens (RR 0.4 [0.1, 1.2]) or ethamsylate (RR 0.88 [0.3, 2.9]) when these treatments were used for heavy menstrual bleeding. (ABSTRACT TRUNCATED)

Antifibrinolytic Agents↗
PubMed2000

Interventions for treating chronic pelvic pain in women.

BACKGROUND: Chronic pelvic pain is common in women in the reproductive age group and it causes disability and distress and results in significant costs to health services. The pathogenesis of chronic pelvic pain is poorly understood. Often, investigation by laparoscopy reveals no obvious cause for pain. There are several possible explanations for chronic pelvic pain including undetected irritable bowel syndrome, the vascular hypothesis where pain is thought to arise from dilated pelvic veins in which blood flow is markedly reduced and altered spinal cord and brain processing of stimuli in women with chronic pelvic pain. As the pathophysiology of chronic pelvic pain is not well understood, its treatment is often unsatisfactory and limited to symptom relief. Currently, the main approaches to treatment include counselling or psychotherapy, attempting to provide reassurance using laparoscopy to exclude serious pathology, progestogen therapy such as medroxyprogesterone acetate, and surgery to interrupt nerve pathways. OBJECTIVES: We aimed to identify and review treatments for chronic pelvic pain in women in the reproductive years. The review included studies of patients with a diagnosis of pelvic congestion syndrome but excluded those with pain known to be caused by i) endometriosis, ii) primary dysmenorrhoea (period pain), iii) pain due to chronic pelvic inflammatory disease, or iv) irritable bowel syndrome. SEARCH STRATEGY: The search strategy adopted by the Cochrane Menstrual Disorders and Subfertility Group was used. SELECTION CRITERIA: Randomised controlled trials (RCTs) with women who had chronic pelvic pain, excluding endometriosis, primary dysmenorrhoea, pain due to chronic pelvic inflammatory disease, or irritable bowel syndrome. The reviewers were prepared to consider studies of any intervention including lifestyle, physical, medical, surgical and psychological treatments. Outcome measures were pain rating scales, quality of life measures, economic analyses and adverse events. DATA COLLECTION AND ANALYSIS: For each included trial, information was collected regarding the method of randomisation, allocation concealment, blinding, whether an intention to treat analysis could possibly be performed and relevant interventions and outcomes (see previous sections). Data were extracted independently by the two reviewers, using forms designed according to the Cochrane guidelines. MAIN RESULTS: Seven studies were identified of which four were of good methodological quality. One study was reported in a brief abstract only and was excluded. Progestagen (Medroxyprogesterone acetate) was associated with a reduction of pain during treatment. Counselling supported by ultrasound scanning was associated with reduced pain and improvement in mood. A multidisciplinary approach was beneficial for some outcome measures. Adhesiolysis was not associated with an improved outcome apart from where adhesions were severe. REVIEWER'S CONCLUSIONS: Further studies to confirm these observations are needed, together with full reporting of those studies which have been undertaken. Given the prevalence and health care costs associated with chronic pelvic pain in women, randomised controlled trials of other medical, surgical and psychological interventions are urgently required.

Chronic Disease↗
PubMed2002

Pressurised metered-dose inhalers versus all other hand-held inhalers devices to deliver bronchodilators for chronic obstructive pulmonary disease.

BACKGROUND: Bronchodilator therapy for COPD may be delivered by a number of different inhaler devices. OBJECTIVES: To determine the efficacy of pressurised metered dose inhalers (pMDI) compared to any other handheld inhaler device for the delivery of bronchodilators in non-acute COPD. SEARCH STRATEGY: The Cochrane Collaboration, Asthma and Wheeze Randomised Controlled Clinical Trials register was searched for studies. The UK pharmaceutical companies who manufacture inhaled COPD medication were also contacted. SELECTION CRITERIA: Two reviewers independently reviewed the results of computerised search and any potentially relevant articles were obtained in full. DATA COLLECTION AND ANALYSIS: One reviewer extracted details of each trial and a second reviewer checked all extracted data. Dichotomous outcomes such as exacerbation rate were assessed using relative risk, with 95% confidence interval (CI). MAIN RESULTS: Fourteen studies appeared potentially relevant but only three studies (61 patients) met the entry criteria. Two studies compared a dry powder device (Turbuhaler or Rotahaler) with a pMDI for beta2-agonist delivery, and one (36 patients cross-over design) the Respimat (soft mist device for ipratropium) vs a pMDI. For the Turbuhaler and Rotahaler, none of the reported outcome measures were significantly different. The Rotahaler study used a high and low dose of medication with or without large volume spacer. The study using the Respimat showed significant increases in FEV1 when compared to a pMDI (difference in change from base line 70 ml, 95% CI 10, 130 ml). The effect on change in FVC was of similar size. There were no differences between these two devices for any other reported outcomes. Although none of the included studies required prior patient ability to use any of the inhalers (and no study mentioned device training), it was assumed that all patients randomised into the study would have undergone training in use of the study inhalers and were capable of using those devices. REVIEWER'S CONCLUSIONS: In patients with stable COPD, pMDI produced similar outcomes to a dry powder device for delivering beta2-agonists, but the very small number of studies and included patients does not permit firm conclusions to be drawn. The soft mist device for ipratropium was more effective than a pMDI, but the data come from one small study. There need to be further well designed randomised controlled trials to define the role of inhaler devices using bronchodilators in stable COPD.

Adrenergic Agonists↗
PubMed2003

Transcranial magnetic stimulation for the treatment of obsessive-compulsive disorder.

BACKGROUND: Transcranial magnetic stimulation (TMS) was introduced as a neurophysiological technique in 1985 when Anthony Barker and his team developed a compact machine that permitted non-invasive stimulation of the cerebral cortex (Barker 1985). Since its introduction, TMS has been used to evaluate the motor system, to study the function of several cerebral regions, and for the pathophysiology of several neuropsychiatric illnesses. In addition, it has been suggested that TMS might have therapeutic potential. Some controlled studies have evaluated the effects of repetitive TMS (rTMS) in patients with obsessive-compulsive disorder (OCD). Greenberg (Greenberg 1997) observed that a single session of right prefrontal cortex stimulation produced a significant decrease in compulsive urges in OCD patients lasting over eight hours. Other studies have reported transitory improvements in mood but there are no observations for changes in anxiety or obsessions. OBJECTIVES: To develop a systematic review on the clinical efficacy and safety of transcranial magnetic stimulation from randomised controlled trials in the treatment of obsessive-compulsive disorder. SEARCH STRATEGY: An electronic search was performed including the Cochrane Collaboration Depression, Anxiety and Neurosis Review Group trials register (last searched June, 2002), the Cochrane Controlled Trials Register (Issue 2, 2002), MEDLINE (1966-2002), EMBASE (1974-2002), PsycLIT (1980-2002), and bibliographies from reviewed articles. SELECTION CRITERIA: Randomised controlled trials assessing the therapeutic efficacy and safety of transcranial magnetic stimulation for obsessive-compulsive disorder. DATA COLLECTION AND ANALYSIS: All reviewers independently extracted the information and verified it by cross-checking. Disagreements were resolved through discussion. MAIN RESULTS: Three trials were included in the review and only two contained data in a suitable form for quantitative analysis. It was not possible to pool any results for a meta-analysis. No difference was seen between rTMS and sham TMS using the Yale-Brown Obsessive-Compulsive Scale or the Hamilton Depression Rating Scale for all time periods analysed. REVIEWER'S CONCLUSIONS: There are currently insufficient data from randomised controlled trials to draw any conclusions about the efficacy of transcranial magnetic stimulation in the treatment of obsessive-compulsive disorder.

Humans↗
PubMed2006

Hormonal versus non-hormonal contraceptives in women with diabetes mellitus type 1 and 2.

BACKGROUND: Adequate contraceptive advice is important in women with diabetes mellitus type 1 and 2 to reduce the risk of maternal and infant morbidity and mortality in unplanned pregnancies. A wide variety of contraceptives are available for these women. However hormonal contraceptives might influence carbohydrate and lipid metabolism and increase micro- and macrovascular complications. So caution in selecting a contraceptive method is required. OBJECTIVES: To investigate whether progestogen-only, combined estrogen/progestogen or non-hormonal contraceptives differ in terms of effectiveness in preventing pregnancy, in their side effects on carbohydrate and lipid metabolism and in long-term complications such as micro- and macrovascular disease, when used in women with diabetes mellitus. SEARCH STRATEGY: The search was performed in MEDLINE, EMBASE, CENTRAL/CCTR, POPLINE, CINAHL, WorldCat, ECO, ArticleFirst, the Science Citation Index, the British Library Inside, and reference lists of relevant articles. Last search was performed in May 2005. In addition, experts in the field and pharmaceutical companies marketing contraceptives were contacted to identify published, unpublished or ongoing studies. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials that studied women with diabetes mellitus comparing: 1. hormonal versus non-hormonal contraceptives. 2. progestogen-only versus estrogen/progestogen contraceptives. 3. contraceptives containing <50 microg estrogen versus contraceptives containing > or = 50 microg estrogen. 4. contraceptives containing 'first'-, 'second'- and 'third'-generation progestogens, drospirenone and cyproterone acetate. Principal outcomes were contraceptive effectiveness, diabetes control, lipid metabolism and micro- and macrovascular complications. DATA COLLECTION AND ANALYSIS: Two investigators evaluated the titles and abstracts from the literature search. Quality assessment was performed independently with discrepancies resolved by discussion or consulting a third reviewer. Because the trials differed in studied contraceptives, participant characteristics and methodological quality, we could not combine the data in a meta-analysis. The trials were therefore examined on an individual basis and narrative summaries were provided. MAIN RESULTS: Three randomised controlled trials were included. Only one was of good methodological quality. It compared the influence of levonorgestrel-releasing IUD versus copper-IUD on carbohydrate metabolism in women with type 1 diabetes mellitus. No difference was found in daily insulin requirement, glycosylated hemoglobin (HbA1c) or fasting blood sugar after twelve months. The other two trials were of limited methodological quality. Both compared progestogen-only pills with different estrogen/progestogen combinations. The trials reported blood glucose levels to remain stable during treatment with most regimens. Only high-dose combined oral contraceptives were found to slightly impair glucose homeostasis. Combined oral contraceptives also appeared to have a minor adverse effect on lipid metabolism whereas progestogen-only contraceptives slightly improved lipid-metabolism. Only one study reported on micro- and macrovascular complications. No signs or symptoms of thromboembolic incidents or visual disturbances were observed. However study duration was short. Minor adverse effects were reported in one study. The trial found progestogen-only pills to cause more bleeding irregularities when compared with combined oral contraceptives. Unintended pregnancies were not observed during any of the studies. AUTHORS' CONCLUSIONS: The three included randomised controlled trials in this systematic review provided insufficient evidence to assess whether progestogen-only and combined contraceptives differ from non-hormonal contraceptives in diabetes control, lipid metabolism and complications. Two of the three studies were of limited methodological quality, sponsored by pharmaceutical companies and described surrogate outcomes. Ideally, an adequately reported, high-quality randomised controlled trial analysing both intermediate outcomes (i.e. glucose and lipid metabolism) and true clinical endpoints (micro- and macrovascular disease) in users of combined, progestogen-only and non-hormonal contraceptives should be conducted. However, due to the low incidence of micro- and macrovascular disease and accordingly the large sample size and follow-up period needed to observe differences in risk, a randomised controlled trial might not be the ideal design.

Blood Glucose↗
PubMed2006

Sodium bicarbonate infusion during resuscitation of infants at birth.

BACKGROUND: For many years, intravenous sodium bicarbonate has been used to reverse acidosis during newborn resuscitation. However, controversy surrounds its use. Most of the evidence has been derived from studies in animals, adult humans, or in uncontrolled, descriptive experiments. Despite the lack of evidence from the human neonatal population and concerns about its safety, some international resuscitation guidelines still recommend the use of sodium bicarbonate in resuscitation of the newborn. OBJECTIVES: To determine whether an intravenous infusion of sodium bicarbonate, compared to placebo or no treatment, reduces mortality and morbidity (in particular regarding neurodevelopmental outcome) in infants receiving resuscitation in the delivery room at birth. SEARCH STRATEGY: We used the standard search strategy of the Cochrane Neonatal Review Group. Searches were conducted of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2005), MEDLINE (1966 - September 2005), EMBASE (1980 - September 2005) and CINAHL (1982 - September 2005) and Pediatric Research (1987 - September 2005). Unpublished trials were sought by handsearching the conference proceedings of American Pediatric Society/Society for Pediatric Research (1990 - 2005) and European Society for Paediatric Research (1993 - 2005). SELECTION CRITERIA: Randomised or quasi-randomised controlled trials of newborn infants receiving sodium bicarbonate infusion during any resuscitation in the delivery room at birth. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. Study authors were contacted for additional information. MAIN RESULTS: We found one randomised controlled trial that fulfilled the eligibility criteria (Lokesh 2004) that compared treating asphyxiated newborn infants (infants continuing to need positive pressure ventilation at 5 minutes after birth) with sodium bicarbonate infusion (N = 27) versus 5% dextrose (N = 28). They found no evidence of an effect on mortality prior to discharge [Relative risk 1.04 (95% confidence interval 0.49 to 2.21)], abnormal neurological examination at discharge [Relative risk 0.86 (95% confidence interval 0.30 to 2.50)] or a composite outcome of death or abnormal neurological examination at discharge [Relative risk 0.97 (95% confidence interval 0.59 to 1.60)]. There was no statistically significant difference in the incidence of encephalopathy [Relative risk 1.30 (95% confidence interval 0.88 to 1.92)], intraventricular haemorrhage [Relative risk 1.04 (95% confidence interval 0.23 to 4.70)] and neonatal seizures [Relative risk 1.19 (95% confidence interval 0.50 to 2.82)]. No long term neurodevelopmental outcomes were assessed. AUTHORS' CONCLUSIONS: There is insufficient evidence from randomised controlled trials to determine whether the infusion of sodium bicarbonate reduces mortality and morbidity in infants receiving resuscitation in the delivery room at birth.

Asphyxia Neonatorum↗
PubMed2005

Exercise for treating isolated anterior cruciate ligament injuries in adults.

BACKGROUND: The anterior cruciate ligament (ACL) is the most frequently injured ligament of the knee. Injury causes pain, effusion and inflammation leading to the inability to fully activate the thigh muscles. Regaining muscular control is essential if the individual wishes to return to pre-injury level of function and patients will invariably be referred for rehabilitation. OBJECTIVES: To present the best evidence for effectiveness of exercise used in the rehabilitation of isolated ACL injuries in adults, on return to work and pre-injury levels of activity. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PEDro - The Physiotherapy Evidence Database, CINAHL, AMED, and reference lists of articles. SELECTION CRITERIA: Randomised controlled trials and quasi-randomised trials testing exercise programmes designed to rehabilitate adults with isolated ACL injuries. Trials where participants were randomised to receive any combination of the following: no care, usual care, a single-exercise intervention, and multiple-exercise interventions. The primary outcome measures of interest were returning to work and return to pre-injury level of activity post treatment, at six months and one year. DATA COLLECTION AND ANALYSIS: All trials judged to have met the inclusion criteria were independently assessed for methodological quality by use of a 15 point checklist. Pairs of authors independently extracted data. For each study, relative risk and 95% confidence intervals were calculated for dichotomous outcomes and mean differences and 95% confidence intervals calculated for continuous outcomes. MAIN RESULTS: Nine trials, involving 391 participants met the inclusion criteria of the review. Only two trials, involving 76 participants, reported conservative rehabilitation and seven trials, involving 315 participants, evaluated rehabilitation following ACL reconstruction. Methodological quality scores varied considerably across the trials, with the nature of participant and assessor blinding poorly reported. Trial comparisons fell into six categories. Pooling of data was rarely possible due to lack of appropriate data as well as the wide variety in outcome measures and time points reported. Insufficient evidence was found to support the efficacy of one exercise intervention over another. AUTHORS' CONCLUSIONS: This review has demonstrated an absence of evidence to support one form of exercise intervention against another and the use of supplementary exercises in the management of isolated ACL injuries. Further research in the form of large scale well designed randomised controlled trials with suitable outcome measures and surveillance periods, using standardised reporting should be considered.

Adolescent↗
PubMed2006

Oxygen therapy in the pre-hospital setting for acute exacerbations of chronic obstructive pulmonary disease.

BACKGROUND: Chronic obstructive pulmonary disease (COPD), a leading cause of morbidity and mortality in the developed world, is characterised by acute deterioration in symptoms. During these exacerbations, people are prone to developing alveolar hypoventilation, which may be contributed to by the administration of high inspired oxygen concentrations. OBJECTIVES: The objective of the review was to determine the effect of different inspired oxygen concentrations ("high flow" compared to "controlled") in the pre-hospital setting on outcome for people with acute exacerbations of COPD. SEARCH STRATEGY: We searched the Cochrane Airways Group Specialised Register (August 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to August 2005), EMBASE (1980 to wk 32, 2005), CINAHL (1982 to August wk 1, 2005) and reference lists of articles. We also contacted authors of identified RCTs for details of other relevant, published and unpublished studies. SELECTION CRITERIA: Randomised controlled trials comparing oxygen therapy at different concentrations or oxygen therapy versus placebo in the pre-hospital setting for treatment of acute exacerbations of COPD were eligible. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. MAIN RESULTS: The search identified a total of 741 abstracts, of which 18 were selected as potentially relevant, only two of the 18 studies were randomised controlled trials and eligible for inclusion in the review, but were ongoing and had no data available for analysis. AUTHORS' CONCLUSIONS: No relevant trials have been published to date, so there is no evidence to indicate whether different oxygen therapies in the pre-hospital setting have an effect on outcome for people with acute exacerbations of COPD. There is an urgent need for robust, well-designed randomised controlled trials to investigate the effect of oxygen therapies in the pre-hospital setting for people with acute exacerbations of COPD.

Emergency Medical Services↗
PubMed2006

[Evaluation of a multidisciplinary management by a health care network for patients with chronic heart failure].

OBJECTIVES: To evaluate the impact, at three months, of a multidisciplinary management by a health care network for patients with chronic heart failure, compared with a historic control group. METHODS: We carried out an exhaustive prospective investigation of 68 patients included in the network in 2001 (stage II to IV of NYHA classification). The historic control was 64 patients hospitalized in 2000 with the same inclusion criteria. RESULTS: Mean age (78 years) and the initial severity of heart failure (stage NYHA II: 43%, III: 55%, IV: 2%) did not differ between the two groups. Seven parameters significantly improved at three months in intervention group: systolic blood pressure, heart frequency, walking distance covered in six minutes, quality of life score, prescription of angiotensin converting enzyme inhibitor at maximal dose, prescription of beta-blocker and the patient's compliance with therapy. The three months survival without event (hospital readmission or death) did not significantly differ between the two groups: 45% [33-57] in 2000 versus 41% [29-53] in 2001. CONCLUSION: The functional status and treatments of the patients significantly improved three months after their inclusion in health care network. The impact of the health care network for chronic heart failure management should be studied by randomised trials.

Adrenergic beta-Antagonists↗
PubMed2005

Role of topical antibiotics in hip surgery. A prospective randomised study.

BACKGROUND: The effectiveness of topical antibiotics has been shown well enough in vitro to justify strong consideration of their use in orthopaedic procedures. We carried out a randomised prospective trial to study the role of topical chloramphenicol ointment application on postoperative wounds following surgeries for hip fractures. METHODS: One hundred cases with fracture neck of femur were enrolled in the study. They were randomized into two treatment groups: one group had chloramphenicol ointment applied at the surgical site at the end of procedure and 3rd day postoperatively, while the control group did not. The wound was checked on the 3rd, 6th, 12th and 30th days postoperatively, by a tissue viability nurse on the guidelines issued by the Scottish Centre for Infection and Environmental Health (SCIEH). RESULTS: We had 12 cases with superficial infection of which 8 belonged to control group. The risk of developing wound infection, however, was not significant with and without the use of chloramphenicol ointment (relative risk 0.430, 95% confidence interval (CI) 0.120-1.544). Using multivariate analysis, no association was found between wound infection and age, gender, type of fracture or type of surgical procedure. Smoking was found to be the only factor significantly associated with infection, with the relative risk for current smokers compared with former/non-smokers being 7.29 (95% CI 1.62-32.67). CONCLUSION: Awareness is needed amongst the general public about the ill effects of smoking. There was reduction in the incidence of wound infection with the use of topical antibiotic ointment. However, this was not statistically significant to recommend its use in routine practice. A larger study should provide useful information on the role of topical antibiotic and its effect on postoperative wound infection.

Administration, Topical↗
PubMed2003

Polymyalgia rheumatica and temporal arteritis: evidence and guidelines for diagnosis and management in older people.

Polymyalgia rheumatica and temporal arteritis commonly present for the first time in older people. Guidelines for diagnosis, investigation and management are available but have largely been developed by rheumatologists from studies where older people have been excluded. It is not clear whether geriatricians care for a group of patients with different clinical presentations compared to those under the care of other clinicians. There is a need for further prospective studies and randomised controlled trials to clarify a host of outstanding issues to improve the care of older people with polymyalgia rheumatica and temporal arteritis.

Aged↗
PubMed2004

Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group.

OBJECTIVE: To determine whether poor reporting of methods in randomised controlled trials reflects on poor methods. DESIGN: Observational study. SETTING: Reports of randomised controlled trials conducted by the Radiation Therapy Oncology Group since its establishment in 1968. PARTICIPANTS: The Radiation Therapy Oncology Group. Outcome measures Content of reports compared with the design features described in the protocols for all randomised controlled trials. RESULTS: The methodological quality of 56 randomised controlled trials was better than reported. Adequate allocation concealment was achieved in all trials but reported in only 42% of papers. An intention to treat analysis was done in 83% of trials but reported in only 69% of papers. The sample size calculation was performed in 76% of the studies, but reported in only 16% of papers. End points were clearly defined and alpha and beta errors were prespecified in 76% and 74% of the trials, respectively, but only reported in 10% of the papers. The one exception was the description of drop outs, where the frequency of reporting was similar to that contained in the original statistical files of the Radiation Therapy Oncology Group. CONCLUSIONS: The reporting of methodological aspects of randomised controlled trials does not necessarily reflect the conduct of the trial. Reviewing research protocols and contacting trialists for more information may improve quality assessment.

Clinical Trials, Phase III as Topic↗