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PubMed1998

Multidimensional assessment of elderly people in the community.

Multidimensional assessment has been advocated as the most appropriate type of screening activity for elderly people. The emphasis has traditionally been on screening for problems with function, disability and dependency in order to identify service and treatment needs. Several randomised trials of multidimensional assessment have been conducted. The UK trials have been conducted in the setting of general practice, while trials in other European countries as well as the US have targeted elderly people living in the community. Although there appear to be possible benefits from multidimensional assessment, for example in reduced mortality, disability and hospital inpatient admissions, these trials have not been consistent in their findings, nor have they been large enough to produce results of sufficient precision and certainty to inform policy. There is stronger evidence that multidimensional assessment can prevent falls but the size of the benefit for serious falls is quite small. The UK health policy of regular assessment of people aged 75 years and above to be carried out in general practice has been implemented haphazardly with little guidance on appropriate methods and levels of assessment. A large randomised trial is currently underway in the UK which will provide evidence on the cost effectiveness of a range of different strategies for assessment.

Accidental Falls↗
PubMed2006

A survey of inclusion of the time element when reporting adverse effects in randomised controlled trials of cyclo-oxygenase-2 and tumour necrosis factor alpha inhibitors.

BACKGROUND: The adequacy of reporting the time element in adverse effects in articles on randomised clinical trials of cyclo-oxygenase-2 and tumour necrosis factor (TNF)alpha antagonists was surveyed. METHODS: Prominent rheumatology and general/internal medicine journals were searched for all randomised controlled trials published about cyclo-oxygenase-2 and TNFalpha inhibitor use in rheumatological diseases up to November 2005. Reporting of time to the occurrence of the adverse effects, the use of patient years as the time frame of the reported adverse effects and the use of annual standard incidence ratios based on the surveillance, epidemiology and end-results (SEER) programme when reporting neoplasms as potential adverse effects of TNFalpha antagonists were specifically tabulated. RESULTS: Only 23 of 70 (33%) of all articles gave the specific time of onset of an adverse effect. Nine studies used patient years to report the adverse effects and six studies used annual standard incidence ratios, using SEER, as the comparator. CONCLUSION: In reporting of adverse effects in randomised clinical trials, a particularly neglected issue is the reporting of the time dimension of adverse effects.

Antirheumatic Agents↗
PubMed2004

[Results of randomised clinical trial: not necessarily positively received].

The acceptance for publication and the implementation of the results of a randomised clinical trial are determined not only by the quality of the study, but also by its timing and the prevailing opinion prior to the study. In a randomised study, comparing laparoscopic and open fundoplication in patients with gastro-oesophageal reflux, interim analysis showed statistically significantly more complications related to laparoscopic intervention. Publication of the study led to an avalanche of criticism focusing mainly on the inexperience of the surgeons. The cost-effectiveness analysis, showing that open fundoplication had fewer complications and was cheaper, was repeatedly rejected by established journals mainly because of criticism of surgical aspects of the study. In the meanwhile a study on a second group of 100 patients was initiated. They underwent laparoscopic fundoplication conducted by two experienced surgeons. The results were statistically significantly better than in the laparoscopic arm of the initial randomised trial. The learning curve proved to be longer than had previously been thought.

Clinical Competence↗
PubMed2000

[Roaming through the methodology. XX. Randomization as a means of avoiding confounding through indication].

Two methodological issues are central in discussions about the value of randomised studies for evaluation of the effectiveness of medical interventions: confounding by indication and generalizability. Confounding occurs when a factor with bearing on the outcome of disease, has a different distribution among intervention groups. Confounding by indication is a special case and results from the fact that in medical practice the choice between intervention alternatives is dependent on the perceived prognosis of the patient for whom these interventions are considered. As the precise arguments for this choice in general are not explicit and hence not measurable, correction for confounding by indication is impossible, and randomisation is applied. Surprisingly, systematic comparison of the results of randomised and non-randomised studies for the same interventions shows remarkable resemblance. This suggests that non-randomised studies may have value in specific situations, but unfortunately so far we do not know for which situations this may be the case.

Bias↗
PubMed2005

Clinical trial design in hepatocellular carcinoma.

Researchers interested in developing treatments for hepatocellular carcinoma (HCC) face three sets of problems; one set common to all clinical trialists at the beginning of the 21st century, one set related to phase I/II studies ('early drug development') and one set related to the design of phase III (randomised, controlled trials). This review is concerned with the challenges faced in designing high quality clinical trials in patients with HCC. Specific published trials are not discussed other than by way of illustration of the problems faced.

Carcinoma, Hepatocellular↗
PubMed2006

Impact of study design on outcome after endovascular abdominal aortic aneurysm repair. A comparison between the randomized controlled DREAM-trial and the observational EUROSTAR-registry.

BACKGROUND: Patients with abdominal aortic aneurysm (AAA) can be treated by transfemoral endovascular intervention and by conventional open surgery. Level-one evidence of the safety and efficacy of one treatment mode over the other is only provided by a randomised controlled trial (RCT). Results reported by voluntary registries are considered less valid than data from RCTs. On the other hand the outcome of a RCT may not be generalisable to the common practice because of vigorous selection of patients and institutions. PURPOSE: The outcomes reported by the Dutch Randomized Endovascular Aneurysm Management (DREAM) trial were compared with the results of the EURopean collaborators on Stent-graft techniques for AAA Repair (EUROSTAR) registry. METHODS: To obtain comparable study groups with regard to risk factors equal proportions of ASA I, II and III patients as observed in the endovascular arm of the DREAMtrial were selected at random from the EUROSTAR-registry. All patients had an aneurysm of at least 50mm. Only patients, who had been enrolled into the registry from 1999, were selected to avoid the influence of first generation endografts which are not longer in use. Patient characteristics and outcomes of endovascular AAA repair (EVAR) of EUROSTAR and DREAM-trial participants were compared. Differences in early findings between study groups were assessed by Chi-Square tests for discrete variables and by Wilcoxon rank sum tests for continuous variables. Follow-up variables were analysed by Kaplan-Meier and Cox proportional hazard models. RESULTS: Data of 177 patients of the DREAM trial with randomization to EVAR and 856 patients selected in the EUROSTAR-registry were compared. Baseline characteristics were comparable between the EUROSTAR-cohort and EVAR-arm of the DREAM-trial. The 36-month survival-rate was 87.6% for EVAR-arm in the DREAM-trial similar to the 86.8% found in this EUROSTAR-study population. The freedom of secondary procedures reached after 3 years 85.7%, and 86.9% in the DREAM and EUROSTAR-cohort, respectively. CONCLUSION: We found comparable characteristics and outcomes between patients of comparable risk class of the EUROSTAR-registry and the EVAR-cohort of the DREAM-trial. This demonstrates the following: first, the EUROSTAR-data provide reliable information, and further comparisons of registry data with patients treated by conventional AAA surgery may be justified. Secondly, the various outcomes of the randomised DREAM trial appear generalisable, as it agrees with observations in a broad common practice derived database.

Aged↗
PubMed2001

Oral methyl-xanthines for bronchiectasis.

BACKGROUND: Bronchiectasis is characterised by chronic sputum production,bronchial wall dilation,recurrent infection and airflow limitation. Methylxanthines are used in the management of airflow limitation associated with asthma and COPD, where they are also purported to have anti-inflammatory properties. In theory they may be of use in bronchiectasis. OBJECTIVES: To determine the efficacy of methylxanthines in the treatment of bronchiectasis. SEARCH STRATEGY: The Cochrane Airways Group clinical trials register derived from MEDLINE,EMBASE and hand searches using the terms bronchiectasis, aminophylline, theophylline and methyl- xanthine SELECTION CRITERIA: Only randomised controlled trials were to be considered. DATA COLLECTION AND ANALYSIS: The results of the searches were reviewed by two authors. Searches yielded seven trials none of which met the inclusion criteria. MAIN RESULTS: No randomised controlled trials were identified. REVIEWER'S CONCLUSIONS: Further research is required to establish if the methylxanthines have a role in the treatment of bronchiectasis.

Administration, Oral↗
PubMed2003

Ionisers for chronic asthma.

BACKGROUND: Previous reports have shown that ion content in the air may have an effect on respiratory function. Results from studies which test the efficacy of air ionisers to reduce asthma symptoms are often inconclusive and their use as a treatment for asthma remains debatable. OBJECTIVES: We conducted a systematic review of the available evidence to determine the effectiveness of positive and negative ion generators in people with asthma. SEARCH STRATEGY: We searched the Cochrane Airways Group Asthma trials register (January 1966 to March 2003), Cochrane Central Register of Controlled Trials (Cochrane Library issue 2, 2003) as well as The Alternative Medicine Database AMED (1985 to March 2003). SELECTION CRITERIA: Randomised controlled trials (parallel or crossover design studies) comparing ionisers with dummy ionisers (being negative or positive ion emitters), in children or adults with chronic asthma. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed titles and abstracts of studies and assessed trial quality. Study quality was determined using two methods:The Cochrane approach to allocation concealment and the five point Jadad scale. MAIN RESULTS: Six studies were selected for inclusion (106 participants). No results were combined as the studies were all of a crossover design. EFFECTS OF NEGATIVE ION GENERATORS (five studies)No study reported a significant difference in lung function between ionised and control air (morning Peak expiratory flow (PEF) - three studies; forced expiratory flow in one second (FEV1) - one study). There were no significant differences in symptoms or beta-2 agonist usage between ionised and control air in three studies. EFFECTS OF POSITIVE ION GENERATORS (one study)This study demonstrated that although positively ionised air was associated with a larger fall in FEV1 with exercise, this did not reach statistical significance. Baseline FEV1 was not demonstrated to be significantly different between treatment groups. REVIEWER'S CONCLUSIONS: Based on the evidence currently available from randomised controlled trials, a recommendation cannot be given for the use of room air ionisers to reduce symptoms in patients with chronic asthma.

Adult↗
PubMed2005

Immunosuppressant and immunomodulatory treatment for dermatomyositis and polymyositis.

BACKGROUND: Idiopathic inflammatory myopathies are chronic skeletal diseases with significant mortality and morbidity despite treatment by corticosteroids. Immunosuppressive agents and immunomodulatory therapy are used to improve disease control and reduce the long-term side effects of corticosteroids. While these treatments are used commonly in routine clinical practice, the optimal therapeutic regimen remains unclear. OBJECTIVES: To systematically review the evidence for the effectiveness of immunosuppressants and immunomodulatory treatments for dermatomyositis and polymyositis. SEARCH STRATEGY: We searched the Cochrane Neuromuscular Disease Group trials register (searched February 2002 and updated in November 2003) and MEDLINE (January 1966 to December 2002). We checked bibliographies of identified trials and wrote to disease experts. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials including patients with probable or definite dermatomyositis and polymyositis as defined by the criteria of Bohan and Peter or definite, probable or mild/early by the criteria of Dalakas. Patients with inclusion body myositis should have been excluded by muscle biopsies. Any immunosuppressant or immunomodulatory treatment including corticosteroids, azathioprine, methotrexate, ciclosporin, chlorambucil, cyclophosphamide, intravenous immunoglobulin, interferon and plasma exchange was considered. Primary outcome was assessment of muscle strength after at least six months. Other outcomes were: change in disability, number of relapses and time to relapse, number of patients in remission and time-to-remission, cumulative corticosteroid dose and serious adverse effects. DATA COLLECTION AND ANALYSIS: Two authors (EC and JH) independently selected trials for inclusion in the review. Four authors independently assessed each study. Methodological criteria and the results of each study were recorded on data extraction forms. MAIN RESULTS: Seven potentially relevant randomised controlled trials were identified. One trial was excluded. Three studies compared immunosuppressant with placebo control, one trial compared one immunosuppressant (methotrexate) with another (azathioprine), another trial compared ciclosporin A with methotrexate and the final trial compared intramuscular methotrexate with oral methotrexate plus azathioprine. The study comparing intravenous immunoglobulin with placebo concluded that the former was superior. Two randomised placebo-controlled trials assessing plasma exchange, leukapheresis and azathioprine produced negative results. The fourth study compared azathioprine with methotrexate and found azathioprine and methotrexate equally effective but methotrexate had a better side effect profile. The fifth study comparing ciclosporin A with methotrexate and the sixth study comparing intramuscular methotrexate with oral methotrexate plus azathioprine found no statistically significant differences between the treatment groups. Immunosuppressants are associated with significant side effects. AUTHORS' CONCLUSIONS: This systematic review highlights the lack of high quality randomised controlled trials that assess the efficacy and toxicity of immunosuppressants in inflammatory myositis.

Azathioprine↗
PubMed2006

Disposable nappies for preventing napkin dermatitis in infants.

BACKGROUND: Napkin dermatitis is a common condition that occurs in otherwise healthy infants. It causes discomfort to infants, anxiety to parents and caregivers and contributes to the load on the health care system. A large variety of napkins, both disposable and non-disposable, are available. Evidence is required to assist carers and health care workers in making informed decisions when balancing the pros and cons of different napkin choices. OBJECTIVES: To assess whether disposable napkins prevent napkin dermatitis in infants. SEARCH STRATEGY: We searched the Skin Group Specialised Register (up to June 2003), the Cochrane Central Register of Controlled Trials in (The Cochrane Library, Issue 3, 2004), MEDLINE (from 1966 to November 2004), EMBASE (from 1980 to February 2003) and CINAHL (from 1982 to November 2004). We searched reference lists of articles. We contacted lead investigators in the area and companies that manufacture disposable napkins for access to unpublished trials. SELECTION CRITERIA: Randomised controlled trials in which disposable napkins were compared with other types of disposable napkins or non-disposable napkins, in infants up to two years of age, for preventing napkin dermatitis. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data. The same two authors independently assessed trials for methodological quality. Attempts were made to contact trial authors of the trials identified for clarification of methods and results of published trials. MAIN RESULTS: We identified 28 studies of the effects of various napkin types on napkin dermatitis. Seventeen studies from nine reports were included. Eleven studies were excluded due to methodology that did not fit the inclusion criteria of this review. Due to the poor reporting of methodology and results of the studies found in this review, there were no quantitative data available for analysis (or meta-analysis). Although the included studies appeared to favour cellulose-core disposable napkins over cloth, absorbent gelling material over cellulose-only core napkins, breathable outer shell over occlusive outer shell napkins and linings impregnated with formulations over plain linings, all of these studies were open to bias due to flawed methodology. AUTHORS' CONCLUSIONS: There is not enough evidence from good quality randomised controlled trials to support or refute the use and type of disposable napkins for the prevention of napkin dermatitis in infants.

Diaper Rash↗
PubMed2006

Does warming up prevent injury in sport? The evidence from randomised controlled trials?

BACKGROUND: The practice of warming up prior to exercise is advocated in injury prevention programs, but this is based on limited clinical evidence. It is hypothesised that warming up will reduce the number of injuries sustained during physical activity. METHODS: A systematic review was undertaken. Relevant studies were identified by searching Medline (1966-April 2005), SPORTDiscus (1966-April 2005) and PubMed (1966-April 2005). This review included randomised controlled trials that investigated the effects of warming up on injury risk. Studies were included only if the subjects were human, and only if they utilised other activities than simply stretching. Studies reported in languages other than English were not included. The quality of included studies was assessed independently by two assessors. RESULTS: Five studies, all of high quality (7-9 (mean=8) out of 11) reported sufficient data (quality score>7) on the effects of warming up on reducing injury risk in humans. Three of the studies found that performing a warm-up prior to performance significantly reduced the injury risk, and the other two studies found that warming up was not effective in significantly reducing the number of injuries. CONCLUSIONS: There is insufficient evidence to endorse or discontinue routine warm-up prior to physical activity to prevent injury among sports participants. However, the weight of evidence is in favour of a decreased risk of injury. Further well-conducted randomised controlled trials are needed to determine the role of warming up prior to exercise in relation to injury prevention.

Athletic Injuries↗
PubMed2001

Review of the radiology in randomised controlled trials in open reduction and internal fixation (ORIF) of displaced intraarticular calcaneal fractures.

The aim of this study was to assess the radiological evaluation of all prospective, randomised, controlled trails of displaced intraarticular calcaneal fractures. A systematic review of the literature, of which only three of 296 references were randomised and controlled, were examined in a blinded fashion. All had preoperative coronal CT for Sander's classification and used a lateral surgical approach or conservative treatment. Thordason (15 patients/11 controls) used interoperative lateral and axial X-rays. Bohler's angle increased on average from 11 to 26 degrees (P<0.001) postoperatively, but decreased (9-8 degrees ) in the conservative group. The posterior facet residual displacement was 1.1 and 4.7 mm, respectively. O'Farrell (12 patients/12 controls) showed 8 out of 12 had Bohler's and Gissane's angle partially or fully restored postoperatively, and not conservatively. Parmar (25 patients/31 controls) used preoperative lateral radiographs, but failed with CT to grade the postoperative reduction, whilst the conservative group was unaltered. There was no systematic, blinded assessment of the change in radiology by the operative intervention. Overall there was weak evidence to support ORIF. In conclusion, there are only three randomised, controlled studies involving small numbers of patients, which showed improved plain radiographic anatomical alignment, in the postoperative but not conservative group. Further prospective randomised, controlled trials with independent and blinded assessment with accurate CT and clinical evaluation will be required before ORIF can be adopted as the best practice.

Calcaneus↗
PubMed2002

Combination of dexamethasone and a somatostatin analogue in the treatment of advanced prostate cancer.

The local microenvironment at the sites of cancer metastases protects tumour cells from anticancer drug-induced apoptosis via mechanisms, such as soluble growth factors and cytokines. The concept of antisurvival factor (ASF) therapy as a component of anticancer treatments aims at neutralising the protective effect conferred upon cancer cells by the survival factor(s) derived by the local microenvironment, in order to enhance the sensitivity and/or reverse the resistance of tumour cells to other anticancer therapeutic strategies. Herein, we review the translation of this concept from ex vivo studies to clinical applications in the setting of prostate cancer refractory to androgen ablation (stage D3). At this stage, which predominantly involves bone metastases, insulin-like growth factor 1 (IGF-1) production (either growth hormone (GH)-dependent or GH-independent) can protect tumour cells from apoptosis, despite the significant suppression of androgens. The application of the ASF therapeutic concept involves the combination of dexamethasone (which suppresses GH-independent IGF-1) and somatostatin analogue (which suppresses endocrine, GH-dependent IGF-1) with the pro-apoptotic effect of the testicular androgen suppression by sustained use of LHRH analogues. In stage D3, patients who had failed anti-androgen withdrawal, chemotherapy and also had several other adverse prognostic features, the ASF-based combination achieved durable objective responses and major symptomatic improvement, paving the way for future applications of this approach. The ASF-based combination therapy illustrates a novel paradigm in cancer treatment: anti-tumour treatment strategies may not only aim at directly inducing cancer cell apoptosis, but can also target the tumour microenvironment and neutralise the protection it confers on metastatic cancer cells. The favourable toxicity profile of this therapeutic approach calls for its testing in a randomised controlled setting in metastatic prostate cancer and, conceivably, in other IGF-1-responsive malignancies.

Androgen Antagonists↗
PubMed2000

NK-104: a novel synthetic HMG-CoA reductase inhibitor.

An elevated level of low-density lipoprotein (LDL)-cholesterol has been recognised as the most important risk factor for coronary artery disease (CAD). Development of the inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) ('statins'), a rate-limiting key enzyme of cholesterol synthesis pathway, has revolutionised the cholesterol-lowering therapy. In the last decade, effective primary and secondary preventive measures have been established in several statin trials to prevent future events of CAD by lowering LDL-cholesterol levels. These results supported the 'lower is better' hypothesis in the relationship between LDL-cholesterol levels and CAD. NK-104 (pitavastatin, previously named as itavastatin or nisvastatin, Kowa Company Ltd., Tokyo) has recently been developed as a new chemically synthesised and powerful statin. On the basis of reported data, the potency of NK-104 is dose-dependent and appears to be equivalent to that of atorvastatin. This new statin is safe and well-tolerated in the treatment of patients with hypercholesterolaemia. The cytochrome P450 system only slightly modifies NK-104, which suggests the clinical advantage of this agent, because the prevalence of clinically significant interactions with a number of other commonly used drugs can be considered to be extremely low. NK-104 can provide a new and potentially superior therapeutic agent when compared with currently available other statins. Randomised controlled clinical trials to assess the long-term effects of this new statin on CAD would be required.

Animals↗
PubMed2005

Reducing the risk of stroke in elderly patients with hypertension: a critical review of the efficacy of antihypertensive drugs.

The risk of ischaemic or haemorrhagic stroke is increased in patients with hypertension, with a linear relationship between elevation of blood pressure and stroke risk being seen even in normotensive individuals. In elderly subjects it has been shown that systolic blood pressure (SBP) elevation in particular is the most important risk predictor for stroke. This is also the rationale for treating elevated SBP in the elderly. Several clinical trials have repeatedly shown the benefits of blood pressure control for prevention of stroke and also for dementia, both of the multi-infarct and Alzheimer subtype. Remaining research questions involve the proper and evidence-based choice of drug treatment in the elderly hypertensive patient. In spite of the introduction of many newer antihypertensive drugs, use of thiazide diuretics is still one of the best treatment choices, as this class of drugs is well proven and cost effective. Another question concerns when and how to treat patients >80 years of age. An ongoing randomised clinical trial, the Hypertension in the Very Elderly trial, is currently trying to evaluate risks and benefits of antihypertensive treatment in this age category.

Aged↗
PubMed2002

Factors affecting general practitioner involvement in a randomised controlled trial in primary care.

AIMS: To investigate factors associated with patient recruitment by general practitioners (GPs) in a randomised controlled trial in primary care. METHODS: Cross sectional survey of 100 GPs who had agreed to recruit patients for a randomised controlled trial. A postal questionnaire was sent to the 100 GPs to collect information on factors associated with recruitment in the randomised controlled trial. RESULTS: The response rate to the survey was 97%. GPs who reported that practice nurses were involved in the research project were significantly more likely to recruit patients into the trial. Age, sex, membership of an independent practitioner association (IPA), number of half days worked, and the number of GPs working in a practice were not associated with recruitment. CONCLUSIONS: Involvement of practice nurses together with GPs may improve recruitment of patients in randomised controlled trials in primary care in New Zealand.

Adult↗