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At least 1,603 records · Page 89Linked to original sources
PubMed2006

Rehabilitation for distal radial fractures in adults.

BACKGROUND: Fracture of the distal radius is a common clinical problem, particularly in older white women with osteoporosis. OBJECTIVES: To examine the effects of rehabilitation interventions in adults with conservatively or surgically treated distal radial fractures. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (December 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 4, 2005), MEDLINE, EMBASE, CINAHL, AMED, PEDro, OTseeker and other databases, conference proceedings and reference lists of articles. No language restrictions were applied. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials evaluating rehabilitation as part of the management of fractures of the distal radius sustained by adults. Rehabilitation interventions such as active and passive mobilisation exercises, and training for activities of daily living, could be used on their own or in combination, and be applied in various ways by various clinicians. DATA COLLECTION AND ANALYSIS: The authors independently selected and reviewed trials. Study authors were contacted for additional information. No data pooling was done. MAIN RESULTS: Fifteen trials, involving 746 mainly female and older patients, were included. Initial treatment was conservative, involving plaster cast immobilisation, in all but 27 participants whose fractures were fixed surgically. Though some trials were well conducted, others were methodologically compromised. For interventions started during immobilisation, there was weak evidence of improved hand function for hand therapy in the days after plaster cast removal, with some beneficial effects continuing one month later (one trial). There was weak evidence of improved hand function in the short term, but not in the longer term (three months), for early occupational therapy (one trial), and of a lack of differences in outcome between supervised and unsupervised exercises (one trial). For interventions started post-immobilisation, there was weak evidence of a lack of clinically significant differences in outcome in patients receiving formal rehabilitation therapy (four trials), passive mobilisation (two trials), ice or pulsed electromagnetic field (one trial), or whirlpool immersion (one trial) compared with no intervention. There was weak evidence of a short-term benefit of continuous passive motion (post external fixation) (one trial), intermittent pneumatic compression (one trial) and ultrasound (one trial). There was weak evidence of better short-term hand function in participants given physiotherapy than in those given instructions for home exercises by a surgeon (one trial). AUTHORS' CONCLUSIONS: The available evidence from randomised controlled trials is insufficient to establish the relative effectiveness of the various interventions used in the rehabilitation of adults with fractures of the distal radius.

Adult↗
PubMed2005

Hyperbaric oxygen therapy for acute ischaemic stroke.

BACKGROUND: Most cases of stroke are caused by impairment of blood flow to the brain (ischaemia) which results in a reduction in oxygen available and subsequent cell death. It has been postulated that hyperbaric oxygen therapy (HBOT) may reduce the volume of brain that will die by greatly increasing the oxygen available, and it may further improve outcome by reducing brain swelling. Some centres are using HBOT routinely to treat stroke. OBJECTIVES: To assess the effectiveness and safety of adjunctive HBOT in the treatment of acute ischaemic stroke. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (last searched 9 January 2004), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 3, 2004), MEDLINE (1966 to July 2004), EMBASE (1980 to July 2004), CINAHL (1982 to July 2004), and DORCTHIM (Database of Randomised Controlled Trials in Hyperbaric Medicine) (from inception to 2004). We handsearched journals and conference proceedings, searched reference lists of articles, and contacted researchers in an effort to identify additional published and unpublished studies. SELECTION CRITERIA: We included all randomised controlled trials that compared the effect of adjunctive HBOT with no HBOT (no treatment or sham). DATA COLLECTION AND ANALYSIS: Two authors used standardised forms to extract the data independently. Each trial was assessed for internal validity with differences resolved by discussion. Data were extracted and entered into RevMan 4.2. MAIN RESULTS: Three randomised controlled trials (106 participants) satisfied the inclusion criteria. The methodological quality of the trials varied but was generally high. Data could be pooled for a limited number of clinically important outcomes. There were no significant differences in mortality rate at six months in those receiving HBOT compared to the control group (relative risk 0.61, 95% confidence interval (CI) 0.17 to 2.2, P value 0.45). Two of 15 scale measures of disability and functional indicated an improvement following HBOT, both at one year follow up: the mean Trouillas Disability Scale was lower with HBOT (mean difference (MD) 2.2 points reduction with HBOT, 95% CI 0.15 to 4.3, P value 0.04) and the mean Orgogozo Scale was higher (MD 27.9 points, 95% CI 4.0 to 51.8, P value 0.02). These improvements were not reflected in other trials or functional scales. AUTHORS' CONCLUSIONS: This systematic review has not found evidence to show that HBOT improves clinical outcomes when applied during the acute presentation of ischaemic stroke. While evidence from the three randomised controlled trials is insufficient to provide clear guidelines for practice, clinical benefit does not seem likely. Further research is required to better define the role of HBOT in this condition.

Brain Ischemia↗
PubMed2005

Adjuvant chemotherapy in invasive bladder cancer: a systematic review and meta-analysis of individual patient data Advanced Bladder Cancer (ABC) Meta-analysis Collaboration.

OBJECTIVES: To evaluate the effect of adjuvant chemotherapy in invasive bladder cancer. METHODS: : We conducted a systematic review and meta-analysis of updated individual patient data from all available randomised controlled trials comparing local treatment plus adjuvant chemotherapy versus the same local treatment alone. RESULTS: Analyses were based on 491 patients from six trials, representing 90% of all patients randomised in cisplatin-based combination chemotherapy trials and 66% of patients from all eligible trials. The power of this meta-analysis is clearly limited. The overall hazard ratio for survival of 0.75 (95% CI 0.60-0.96, p = 0.019) suggests a 25% relative reduction in the risk of death for chemotherapy compared to that on control. Cox regression suggests that small imbalances in patient characteristics do not bias the results in favour of chemotherapy. However, the impact of trials that stopped early, of patients not receiving allocated treatments or not receiving salvage chemotherapy is less clear. CONCLUSIONS: This IPD meta-analysis provides the best evidence currently available on the role of adjuvant chemotherapy for invasive bladder cancer. However, at present there is insufficient evidence on which to reliably base treatment decisions. These results highlight the urgent need for further research into the use of adjuvant chemotherapy. The results of appropriately sized randomised trials, such as the ongoing EORTC-30994 trial are needed before any definitive conclusions can be drawn.

Aged↗
PubMed1986

Response to bronchodilators assessed by lung mechanics.

Abnormalities of compliance and functional residual capacity were shown in eight young children aged 2-8 years with asthma during an acute attack. In a randomised, placebo controlled study treatment with bronchodilator (salbutamol) was associated with a significant improvement in compliance and lessening of hyperinflation as shown by a reduction in functional residual capacity.

Acute Disease↗
PubMed2000

[What studies are useful within the scope of quality assurance?].

The necessity for studies in quality assurance is based on the demand for evaluation of quality assurance measures. Whereas investigation of effects of quality assurance measures under controlled conditions is the goal of quality research, quality assurance deals with the improvement and assurance of quality under routine conditions. In quality research a far reaching control of bias and confounding variables should be aimed at. This is only possible with controlled studies, preferably with the randomised study. With methodological demanding randomised studies the effectiveness of specific quality instruments (e.g. guidelines) could be demonstrated. In the evaluation of quality assurance comparison is also the major principle. This can be done in a controlled non-randomised study, in an empiricle comparison between institutions or in a comparison with a given quality standard. It is hoped, that also in Germany methodological adequate studies will play a major role in quality research and quality assurance in the future.

Clinical Trials as Topic↗
PubMed2005

["Treating to New Targets": plea for a LDL cholesterol target of or below 75 mg/dl in any patient with coronary heart disease].

The "Treating to New Targets" (TNT) trial compared atorvastatin 80 mg (aiming at reducing LDL cholesterol < or = 75 mg/dl) and atorvastatin 10 mg (LDL < or = 100 mg/dl as target) in 10,001 patients with stable coronary heart disease followed up for 5 years. A reduction of major cardiovascular events of 22% was observed in the atorvastatin 80 mg group as compared to the atorvastatin 10 mg group (hazard ratio: 0.78; 95 % interval of confidence: 0.69-0.89; p < 0.001). Such clinical efficacy was obtained while a good drug safety profile was maintained. Total mortality was not significantly different between the two groups. However, and remarkably, cardiovascular death was not the first cause of death anymore in this atorvastatin-treated population. The results of TNT in patients with stable coronary heart disease thus confirm the results of PROVE-IT in patients with acute coronary syndrome. These two randomised controlled trials should encourage considering a LDL cholesterol level of 75 mg/dl (rather than 100 mg/dl) as a new target in any patient with coronary heart disease.

Adult↗
PubMed1997

Impact of covert duplicate publication on meta-analysis: a case study.

OBJECTIVE: To quantify the impact of duplicate data on estimates of efficacy. DESIGN: Systematic search for published full reports of randomised controlled trials investigating ondansetron's effect on postoperative emesis. Abstracts were not considered. DATA SOURCES: Eighty four trials (11,980 patients receiving ondansetron) published between 1991 and September 1996. MAIN OUTCOME MEASURES: Percentage of duplicated trials and patient data. Estimation of antiemetic efficacy (prevention of emesis) of the most duplicated ondansetron regimen. Comparison between the efficacy of non-duplicated and duplicated data. RESULTS: Data from nine trials had been published in 14 further reports, duplicating data from 3335 patients receiving ondansetron; none used a clear cross reference. Intravenous ondansetron 4 mg versus placebo was investigated in 16 reports not subject to duplicate publication, three reports subject to duplicate publication, and six duplicates of those three reports. The number needed to treat to prevent vomiting within 24 hours was 9.5 (95% confidence interval 6.9 to 15) in the 16 non-duplicated reports and 3.9 (3.3 to 4.8) in the three reports which were duplicated (P < 0.00001). When these 19 were combined the number needed to treat was 6.4 (5.3 to 7.9). When all original and duplicate reports were combined (n = 25) the apparent number needed to treat improved to 4.9 (4.4 to 5.6). CONCLUSIONS: By searching systematically we found 17% of published full reports of randomised trials and 28% of the patient data were duplicated. Trials reporting greater treatment effect were significantly more likely to be duplicated. Inclusion of duplicated data in meta-analysis led to a 23% overestimation of ondansetron's antiemetic efficacy.

Antiemetics↗
PubMed2004

Planned elective repeat caesarean section versus planned vaginal birth for women with a previous caesarean birth.

BACKGROUND: When a woman has had a previous caesarean birth, there are two options for her care in a subsequent pregnancy: planned elective repeat caesarean or planned vaginal birth. While there are risks and benefits for both planned elective repeat caesarean birth and planned vaginal birth after caesarean, current sources of information are limited to non-randomised cohort studies. Studies designed in this way have significant potential for bias and consequently conclusions based on these results are limited in their reliability and should be interpreted with caution. OBJECTIVES: To assess, using the best available evidence, the benefits and harms of a policy of planned elective repeat caesarean section with a policy of planned vaginal birth after caesarean section for women with a previous caesarean birth. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (24 June 2004), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2004), and PubMed (1966 to 24 June 2004). SELECTION CRITERIA: Randomised controlled trials with reported data that compared outcomes in mothers and babies who planned a repeat elective caesarean section with outcomes in women who planned a vaginal birth, where a previous birth had been by caesarean. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. MAIN RESULTS: There were no randomised controlled trials identified. REVIEWERS' CONCLUSIONS: Planned elective repeat caesarean section and planned vaginal birth after caesarean section for women with a prior caesarean birth are both associated with benefits and harms. Evidence for these care practices is drawn from non-randomised studies, associated with potential bias. Any results and conclusions must therefore be interpreted with caution. Randomised controlled trials are required to provide the most reliable evidence regarding the benefits and harms of both planned elective repeat caesarean section and planned vaginal birth for women with a previous caesarean birth.

Cesarean Section, Repeat↗
PubMed2004

Educating health professionals to improve quality of care for asthma.

Recent studies have shown significant progress in improving the quality of care for asthma. The most successful interventions have combined multiple elements: educational sessions that engage learners in discussing cases and practicing new skills; use of new resources, tools and practice patterns to enable quality improvement; and reinforcement of improvements through peer support, incentives or administrative review. Future research should include more randomised controlled trials to test the effectiveness of quality improvement interventions, more detailed descriptions of strategies to change health professional behaviour and studies to determine whether effective interventions can be translated to other settings, disseminated widely and sustained over time.

Asthma↗
PubMed2005

Organisation of a proposed Cochrane Diet and Nutrition Field.

The Cochrane Collaboration helps people make well-informed decisions about health care by preparing, maintaining and promoting the accessibility of systematic reviews of the effects of healthcare interventions. In all, 51 Cochrane Review Groups are responsible for preparing and maintaining the reviews. Most of these Review Groups are problem-based. However, there are a number of areas or dimensions of health care, such as the setting of care (eg primary care) or the type of patient/consumer (eg older persons), that cannot be usefully conceptualised as 'health problems'. In order to reflect the interests of these dimensions, or 'fields', of health care more effectively, the Cochrane Collaboration created another type of entity: Cochrane Fields or Networks. The core functions of these Fields are described. It is proposed that a new Cochrane Subfield for Diet and Nutrition should be set up to attract a cadre of new reviewers in order to ensure the proper representation of diet and nutrition expertise in the relevant Collaborative Review Groups. The methodological pitfalls of the use of nonrandomised studies will be a key issue for the new Subfield, since the focus of the Cochrane Collaboration's programme of searching databases, journals and conference proceedings has been on the identification of reports of randomised controlled trials (RCTs). Some of these sources will be need to be searched again for non-RCT studies. The financial considerations of establishing of a Cochrane Subfield for Diet and Nutrition are discussed.

Databases, Bibliographic↗
PubMed2006

[Interactions between radiation and hormonal therapy in breast cancer: simultaneous or sequential treatment].

BACKGROUND: Combining radiation and hormone therapy (administration of selective estrogen receptor modulators) has become common clinical practice in recent years for receptor positive breast cancer. Little is known about a possible interaction of both treatment modalities if they are given simultaneously. Tamoxifen (antiestrogen molecule, triphenylethylene derivative) may theoretically render cancer cells less responsive to radiotherapy arresting hormone-receptor-positive cells in G0/G1 phase and increase the risk of breast and lung fibrosis stimulating the secretion of transforming growth factor beta in human fibroblasts. PURPOSE: This article reviews the published data to assess the impact of sequencing of hormonal and radiation therapy on outcomes in breast cancer. METHODS: Computerised searches for publications debating the sequencing of hormonal therapy relative to radiation therapy were done using MEDLINE data. RESULTS: Results of tamoxifen experiments with cell culture regarding radioprotection of tumour clonogens are conflicting. In contrast to in vitro results, in animal studies no protective effect of tamoxifen was observed. In one in vitro study, letrozole (non-steroid selective aromatase inhibitor) had a radiosensitizing effect on breast-cancer lines. No randomised clinical trials to date have studied sequencing of tamoxifen or other selective estrogen receptor modulators and radiotherapy. Results from retrospective clinical studies which included treatment arms with and without tamoxifen showed reduction in tumour recurrence with tamoxifen. Some of these studies have noted increased risk of lung and breast fibrosis with tamoxifen with radiotherapy. Results of three articles examined the effect of tamoxifen sequence showed no adverse effect on local control or survival in sequential versus concurrent tamoxifen and radiation patients. One of the three studies also assessed the risk of complications with respect to the timing of tamoxifen with radiotherapy. There was no difference in the rates of complications between the two groups. The association of radiation and selective aromatase inhibitors or aromatase inactivators has not been addressed in clinical studies. CONCLUSIONS: Combined application of tamoxifen and radiotherapy improves survival and local control in breast cancer. Available clinical studies do not indicate that the simultaneous application of tamoxifen and radiotherapy is disadvantageous, as was suggested by some of the in vitro studies. The risk of subcutaneous breast and lung fibrosis might be slightly increased if tamoxifen is given simultaneously with radiotherapy. Both treatment modalities should be started early after surgery. There is no sufficient evidence to withhold tamoxifen administration during irradiation of breast cancer. The issue of optimal sequencing of hormonal and radiotherapy should be addressed in randomised clinical trials.

Animals↗
PubMed2001

[Hormonal supplements for postmenopausal women: no evidence of protection against cardiovascular disease].

Atherothrombotic cardiovascular disease is a leading cause of death in women, especially in the postmenopause. It is controversial whether postmenopausal hormone replacement therapy is protective with regard to cardiovascular disease. On the one hand, observational studies consistently show that the risk of cardiovascular disease is 35 to 50% lower among users of hormonal replacement than among non-users. In addition, hormonal replacement is associated with an improvement of the lipid profile and several other potentially beneficial effects. On the other hand, two recent placebo-controlled randomised trials did not find evidence in favour of cardiovascular protection by hormonal replacement. This discrepancy may be explained by insufficient adjustment for lifestyle factors in observational studies and insufficient consideration of methodological flaws in experimental studies, both of which lead to an overestimation of the protective effect of hormonal replacement. Hormonal replacement may affect the pathophysiology of atherothrombosis in several ways, both positive and negative. Progress in this field requires the isolation of the positive effects.

Aged↗
PubMed2001

Field efficacy of a 10 per cent pyriproxyfen spot-on for the prevention of flea infestations on cats.

The clinical application of a new method for using the insect growth regulator, pyriproxyfen, for controlling flea populations in cat-owning homes is evaluated for the first time. In a multicentric, controlled and randomised trial, 107 flea-infested cats were treated with a minimum dose of 10 mg/kg bodyweight pyriproxyfen as a 10 per cent spot-on application on two occasions, with a three-month interval between doses. For comparison, 99 cats received lufenuron suspension orally, once a month, for six months. Flea counts decreased significantly over time in each group and were significantly lower in the pyriproxyfen group than in cats treated with the reference product. The percentage of 'zero-flea' cats increased from 49 per cent on day 30 to 88 per cent on day 180 in the pyriproxyfen group and from 30 to 71 per cent in the lufenuron group at the same time points (P<0.05). Appropriately timed topical applications of pyriproxyfen, therefore, offer a method of flea control in the domestic environment.

Administration, Cutaneous↗
PubMed2005

[Chemoradiotherapy and anal canal cancer].

Local control and sphincter preservation are the two challenges of anal canal cancer treatment. These tumors are radio- and chemo-sensitive and treatment moved from surgical approach, with abdominoperineal resection, to definitive radiation therapy with or without concurrent chemotherapy. Randomised trials proved the benefit of combined modality with chemoradiotherapy and of mitomycine C (MMC) compared with radiotherapy alone, with a toxic death rate of about 2%. Indications of chemoradiotherapy are locally advanced tumor T2 > or = 4 cm, T3-4 or N1-3 but the best modalities of combined treatment are still under debate. Standard chemotherapy is 5 flurouracile (5FU) + MMC, but cisplatinum (CDDP) is an effective and well tolerated substitute for MMC. Favourable results with CDDP-containing regimen in term of toxicity and carcinologic control have been reported in phase II and retrospective studies. Total radiation dose, overall duration of radiation therapy, duration of the gap and indications of additional boost are not clear, but it is demonstrated that overall duration of treatment should be as short as possible to improve the therapeutic radio. Phase II and III studies are ongoing, to evaluate the best chemotherapy regimen between 5FU+MMC and 5FU+CDDP, the benefit of neoadjuvant or maintenance chemotherapy and the interest of increased total dose. Next future could be the utilisation of oral 5FU. This article is a review of past randomised trials, phases II and retrospective study on radiochemotherapy of anal canal carcinoma.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2004

New strategies in anaemia management: ACORD (Anaemia CORrection in Diabetes) trial.

Anaemia is a key component of diabetic nephropathy, but its importance has only recently been recognised. Recombinant human erythropoietin (epoetin) is an established treatment for renal anaemia, and may help to reduce complications associated with diabetic nephropathy, such as cardiovascular disease. The limited experience with the use of epoetin in this patient group prompts the urgent need for clinical data on anaemia correction in early diabetic nephropathy, particularly with regard to benefits on cardiovascular risk reduction. The Anaemia CORrection in Diabetes (ACORD) study will investigate the effects of anaemia correction on cardiac structure and function in patients with early diabetic nephropathy. This 15-month multicentre study will recruit 160 adult patients with diabetes, mild or moderate chronic kidney disease (with creatinine clearance >or=30 ml/min at screening) and moderate anaemia (haemoglobin [Hb], 10.5-13.0 g/dl). Patients will be randomised to one of two groups: the early treatment group will receive subcutaneous epoetin beta (NeoRecormon) at study entry to maintain target Hb levels of 13-15 g/dl, while the control group will reflect current practice and will not receive epoetin therapy until Hb levels decline below 10.5 g/dl. The primary efficacy variable, change in left ventricular mass index, will be evaluated at 15 months following randomisation; secondary efficacy variables will include changes in cardiac structure and function over the study period. The ACORD study should provide valuable information on the benefits of anaemia correction in patients with early diabetic nephropathy. The study will also increase awareness of the importance of treating anaemia associated with diabetes.

Anemia↗
PubMed2004

[Calcaneal fractures--the most frequent tarsal fractures].

Operative treatment of intra-articular calcaneal fractures with anatomical reduction and early mobilisation has lead to a considerable improvement of the functional results of these severe injuries over the recent two decades. New tendencies like modified approaches tailored according to the vascular anatomy, arthroscopic control of joint reduction in conjunction with open or percutaneous procedures, early flap coverage for severe open fractures or closed fractures with full thickness skin necrosis, the use of interlocking plates that further minimises the need of bone grafting and subtalar arthrolysis at the time of hardware removal for fibrous overgrowth have the potential for further improvement of the outcome. The observation from several comparative studies that operative treatment leads to superior results in displaced intra-articular calcaneal fractures has been qualified in a recent prospective, randomised multicentre trial. This paper presents and the authors' experience with the demanding operative treatment of these fractures together with new developments aiming at improving the clinical results.

Arthroscopy↗
PubMed1994

Treatment of Langerhans cell histiocytosis--evolution and current approaches.

Optimal treatment of Langerhans cell histiocytosis remains problematic. The absence of controlled studies and the lack of standard diagnostic and evaluation criteria have impeded therapeutic progress even though knowledge of basic aspects of LCH have advanced. Historical analysis of outcome suggests little improvement until very recently, but marked differences in outcome according to extent of disease. Consequently, major and now successful efforts have been made to stratify LCH patients into different 'risk groups'. Recent findings suggest that combination chemotherapy for multisystem disease is beneficial and that VP-16 is a useful new agent for treating LCH, despite controversies regarding its side effects. The first randomised international treatment study, LCH-1, being conducted by the Histiocyte Society, should resolve some of these controversies. Other experimental therapies may be considered for children with severe, unresponsive LCH.

Biological Factors↗