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PubMed2003

Checking for interviewer bias in outcome assessment: a method for strengthening the design of prospective, randomised trials in surgery.

BACKGROUND: Blind, randomised trials are conceived as the gold standard in clinical research, but this ideal, in its strict sense, can rarely be achieved in surgical settings. One way to strengthen the study design is to check for observer bias in the assessment and evaluation of surgical outcome. METHOD: In a randomised, prospective trial comparing nasogastric versus gastrostomy tubes the primary endpoint was the subjective inconvenience induced by the tube system and was assessed in the context of a standardised face-to-face interview. These interviews were tape-recorded on a pocket memo. Two independent raters listened to these interviews and judged--on the basis of how the interviewer formulated the questions--which treatment arm they thought the patients were assigned to and how confident they were in their judgement. RESULTS: The overall proportion of correct judgements was 50.5% for rater 1 and 53.2% for rater 2. In other words, both judgement performances were not greater than chance. Nevertheless, the raters' confidence in their judgements increased significantly ( P<0.05) in the course of the rating procedure, whereas the actual proportion of correct judgements did not. There was no overlap between the two raters [kappa = 0.022, not significant (NS)] and between actual group assignment and both raters' judgements (kappa = 0.012, NS and kappa = 0.110, NS). CONCLUSION: The two independent raters were not able to detect systematic variations in the interviewing style that were contingent on treatment arm assignment. This gives further credence to the results of the randomised trial showing greater patient-reported discomfort and inconvenience with the nasogastric tube than with the gastrostomy tube. The present report describes a feasible method to monitor subtle biases that may occur in trial settings. This helps to strengthen the design of randomised clinical trials in surgery.

Feasibility Studies↗
PubMed2006

Stem cells in cardiac repair.

Advances in the treatment of acute myocardial infarction have led to increased survival but also an increase in those suffering from heart failure. The concept of adult progenitor cell therapy has grown from observations that cardiac function improves after injection of bone marrow-derived cells into infarcted regions in animal models. The mechanism of action is unclear and is probably multifactorial. Different subpopulations of autologous cells have been utilised in humans with acute myocardial infarction and heart failure, as well different routes of delivery. These small Phase I clinical trials suggest that this approach is safe and leads to clinical improvement, and larger scale randomised control studies are underway. We believe that cell therapy heralds a revolutionary new era in the treatment of disease.

Animals↗
PubMed2003

Prevention of heterotopic ossification after total hip replacement with NSAIDs.

INTRODUCTION: Non steroidal anti-inflammatory drugs (NSAIDs) and prophylactic radiotherapy can prevent ectopic bone formation around the hip after total hip arthroplasty. METHODS: We retrieved from Medline, Embase and the Cochrane Register (clinical) trials and other relevant literature on the prevention of heterotopic ossification (HO) from 1990-2002 for further review. RESULTS: Review of these clinical trials shows that HO is effectively prevented by a postoperative NSAID treatment with indomethacin for at least seven days. The best evidence is available for indomethacin, although naproxen, diclofenac and ibuprofen are also well documented. Short term use of ibuprofen is not effective. If NSAIDs are contraindicated, preoperative or postoperative radiotherapy is a very effective therapeutic option to prevent HO. DISCUSSION AND CONCLUSION: Because of the potential of serious gastrointestinal side effects of NSAIDs and their interaction with anticoagulant drugs, rofecoxib and other COX-2 specific NSAIDs may be a safer option for the treatment of HO. However, randomised controlled studies are needed to confirm the results of the rofecoxib study.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1999

Lofexidine for opiate detoxification: review of recent randomised and open controlled trials.

The objective of this article was to review the data from recently published trials of lofexidine in the treatment of opiate withdrawal, with particular attention to evidence on efficacy, side-effects (particularly hypotension), and the acceptability of this new treatment to the patient population. The authors reviewed data contained within peer-reviewed published reports of clinical trials of lofexidine compared with detoxification using reducing doses of the opiate agonist methadone or the alpha-adrenergic agonist clonidine. Five published reports of clinical trials of lofexidine have been identified from peer-reviewed journals in the eight years between 1990 and 1998--all published within the last three years. Three of the reports compare lofexidine with clonidine, while the remaining two compare it with methadone detoxification. The three comparisons with clonidine find lofexidine to be similar in its moderating effect on the withdrawal syndrome, but without the same extent of problems with hypotension. Comparisons with methadone show a more rapid resolution of withdrawal symptoms with lofexidine--particularly with the accelerated 5-day lofexidine protocol. Such problems of hypotension as were encountered with lofexidine were adequately managed with dose reduction. Acceptability of the treatment to the patient (as measured by retention in treatment) appears to be greater with lofexidine than clonidine, although possibly less than with methadone. Lofexidine is an alpha-2 adrenergic agonist that is increasingly used in the management of opiate withdrawal--notably in the UK. The available data indicate that it is a useful new addition to the armamentarium of the clinician. Future studies should explore its application with improved protocols and in new treatment settings. This article reviews the recent advances in the study of lofexidine as a new treatment for opiate detoxification. It examines the background of the development and introduction of lofexidine into the U.K., with data on the extent to which it is now used in the U.K. in the treatment of opiate addiction. A review is then provided of the published evidence on the use of lofexidine in the management of opiate detoxification, mainly concentrating on the data from recent double-blind randomised trials. Finally, the possible future role of lofexidine in this field is considered.

Clonidine↗
PubMedDate not supplied

Evidence-based guide to slowing the progression of early renal insufficiency.

Early renal insufficiency (ERI), defined as a calculated or measured glomerular filtration rate (GFR) between 30 and 60 mL/min per 1.73 m2, is present in more than 10% of the adult Australian population. This pernicious condition is frequently unrecognised, progressive and accompanied by multiple associated comorbidities, including hypertension, renal osteodystrophy, anaemia, sleep apnoea, cardiovascular disease, hyperparathyroidism and malnutrition. Several treatments have been suggested to retard GFR decline in ERI, including blood pressure reduction, angiotensin-converting enzyme inhibition, angiotensin receptor antagonism, calcium channel blockade, cholesterol reduction, smoking cessation, erythropoietin therapy, dietary protein restriction, intensive glycaemic control and early intensive multidisciplinary patient education within a renal unit. In addition, specific interventions have been reported to be renoprotective in atherosclerotic renal artery stenosis, diabetic nephropathy, lupus nephritis and certain forms of primary glomerulonephritis. The present paper reviews the available published randomised controlled clinical trials and meta-analyses supporting (or refuting) a role for each of these therapeutic manoeuvres.

Disease Progression↗
PubMed2000

Are the pneumococcal polysaccharide vaccines effective? Meta-analysis of the prospective trials.

The objective was to review the evidence of effectiveness of the polyvalent polysaccharide pneumococcal vaccine from prospective properly randomised controlled trials comparing pneumococcal vaccines with placebo in subjects who are immunocompetent and those likely to have an impaired immune system. Databases searched included the Cochrane Library, (issue 2, 2000), MEDLINE (1966-August 2000), PubMed (to August 2000) and EMBASE ( to August 2000). Reference lists of reports and reviews were also searched. To be included in the analysis, a study had to have been a prospective randomised comparison of a polysaccharide pneumococcal vaccine (any valency) and to have a placebo or no treatment comparison group. Papers had to report important clinical outcomes, such as rates of pneumonia, pneumococcal pneumonia, lower respiratory tract infections, pneumonia deaths or bacteraemia. Serological outcomes were not sought. Thirteen randomised comparisons with over 45,000 subjects were identified in an extensive literature review. Eight studies had a quality score of 3 or more on a scale of 1 to 5. In three comparisons with 21,152 immunocompetent subjects (South African gold miners, New Guinea highlanders) pneumococcal vaccination was effective in reducing the incidence of all-cause pneumonia (relative risk 0.56, 95% confidence interval 0.47 to 0.66), pneumococcal pneumonia (0.16; 0.11 to 0.23), pneumonia deaths (0.70; 0.50 to 0.96) and bacteraemia (0.18; 0.09 to 0.34). In ten comparisons in over 24,000 people who were elderly or likely to have impaired immune systems, pneumococcal vaccination was without effect for any outcome. Present guidelines recommend pneumococcal vaccination for "high-risk" groups. There is no evidence from randomised trials that this is of any benefit.

Bacteremia↗
PubMed1999

Combined modality therapy of rectal cancers.

Rectal cancer accounts for about 10% of new cancer cases each year. It strikes men and women at nearly the same rate, generally in the range of 50-80 years of age, with rising incidence with age. Despite simple screening procedures rectal cancer is often advanced when discovered. Current trends in the management of cancer have focused on organ preservation and improved quality of life without compromising the overall survival. During the last decade substantial progress has been made in treatment modalities: new and improved radiation techniques (conformal radiotherapy, altered fractionation, brachytherapy), chemotherapy (protracted infusion, use of radiosensitizers) and development of surgical procedures-enabling safer postoperative irradiation. In patients with advanced/unresectable disease aggressive combined chemoradiation can be added prior to surgery to downstage the tumour and increase the proportion treated with anal-rectal-sparing procedures. Preoperative chemoradiation therapy regimens are as safe and tolerable as the standard postoperative treatment. In this presentation indications for preoperative radiochemotherapy will be discussed in detail, together with treatment-related side effects, prognostic parameters, tumour response and outcome. Different irradiation settings and chemotherapy schedules are described. In patients with primary resectable disease (mainly Dukes C) several prospective randomised trials have shown less local recurrence with postoperative combined modality therapy.

Antineoplastic Agents↗
PubMed2004

Gastrostomy feeding in cerebral palsy: a systematic review.

AIMS: To determine benefits and risks for gastrostomy or jejunostomy feeding compared with oral feeding for children with cerebral palsy. METHODS: Systematic review. SEARCH STRATEGY: electronic databases--Cochrane Library, Medline, Embase, Cinahl, Lilacs, databases of theses, grey literature. INCLUDED: relevant systematic reviews, randomised controlled trials, observational studies, case reports. EXCLUDED: non-systematic reviews and qualitative research. PARTICIPANTS: children with cerebral palsy. INTERVENTION: use of gastrostomy or jejunostomy tube to provide nutrition. OUTCOME: evaluated outcome measures included death, growth, gastro-oesophageal reflux, other complications, psychosocial aspects, and caregiver wellbeing. RESULTS: No relevant systematic reviews or randomised controlled trials were found. Two cohort studies, 15 case series, and eight case reports met the inclusion criteria. Eight studies specifically described percutaneous endoscopic gastrostomy as the intervention. Weight gain resulted from gastrostomy feeding in most cases. There was an approximately fourfold increased risk of death reported in one cohort study for the gastrostomy fed children. Many complications were reported, including potential for increased gastro-oesophageal reflux and fluid aspiration into the lungs. CONCLUSIONS: Benefits associated with gastrostomy or jejunostomy feeding are difficult to assess from the available evidence. Risks of gastrostomy, particularly in relation to surgical complications, have been described but the size of the risk could not be quantified. The finding of a higher death rate for children fed by gastrostomy may merely reflect the greater disability of these compared with orally fed children. Lack of available evidence and the substantial risk of bias in observational studies suggests that a well conducted randomised controlled trial of sufficient size will be needed to answer these problems.

Cerebral Palsy↗
PubMed2004

Evidence-based medicine in orthopaedics.

Evidence-based medicine (EBM) is medicine based on the sum of personal clinical experience and clinical studies with the best possible design (preferably, but not necessarily, randomised controlled trials or RCTs), while focusing on the expectancies of patients and institutions.

Belgium↗
PubMed1995

Empiric monotherapy in neutropenia: a realistic goal?

Infection remains the major cause of morbidity and mortality for cancer patients who become granulocytopenic as a result of chemotherapy. Treatment is instituted at the first sign of infection and before the identification of the causative pathogen (empiric treatment). For many years, standard empiric treatment has been combination therapy with beta-lactams and aminoglycosides. The advent of new broad spectrum antibiotics, such as ceftazidime, has introduced the possibility of empiric monotherapy. However, ceftazidime has only modest activity against infections due to Gram-positive organisms, which presently account for at least 50% of infections in neutropenic patients, and resistance to ceftazidime in Gram-negative organisms has been documented. Meropenem is a new carbapenem with a broad antibacterial spectrum with greater in vitro activity than ceftazidime against staphylococci, streptococci and many Gram-negative bacteria. A comparative study of intravenous meropenem (1 g 8-hourly) and ceftazidime (2 g 8-hourly) in the empiric treatment of febrile neutropenic patients with haematological malignancies has been conducted. In an open, randomised trial of the treatment of 338 febrile episodes, all patients survived to 72 hours on both treatments, and meropenem was found to be at least as clinically effective as ceftazidime in eradicating both Gram-positive and Gram-negative infections. Early modification of treatment (48-72 hours) was required for approximately 40% of patients but occurred less frequently in patients treated with meropenem than with ceftazidime. Tolerability of both treatments was good. Meropenem should be compared with standard combination therapy in a large randomised trial before adopting it as empiric monotherapy for febrile neutropenic patients.

Bacterial Infections↗
PubMed2004

Acupuncture for induction of labour.

BACKGROUND: This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. The use of complementary therapies is increasing and some women look to complementary therapies during pregnancy and childbirth to be used alongside conventional medical practice. Acupuncture involves the insertion of very fine needles into specific points of the body. The limited observational studies to date suggest acupuncture for induction of labour appears safe, has no known teratogenic effects, and may be effective. The evidence regarding the clinical effectiveness of this technique is limited. OBJECTIVES: To determine the effects of acupuncture for third trimester cervical ripening or induction of labour. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register (February 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2003), PubMed (1966 to present), CISCOM (1960 to present), EMBASE (1980 to present) and bibliographies of relevant papers. SELECTION CRITERIA: Clinical trials comparing acupuncture used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods. DATA COLLECTION AND ANALYSIS: A strategy was developed to deal with the large volume and complexity of trial data relating to labour induction. This involved a two-stage method of data extraction. MAIN RESULTS: One trial of 56 women was included in the review. Data were not in a form that could be included in the meta-analysis. REVIEWER'S CONCLUSIONS: There is a need for well-designed randomised controlled trials to evaluate the role of acupuncture to induce labour and for trials to assess clinically meaningful outcomes.

Acupuncture Therapy↗
PubMedDate not supplied

The cult of the double-blind placebo-controlled trial.

The double-blind, placebo-controlled trial is held as the gold standard in medical knowledge, but this tool of investigation has its weaknesses. These include ethical limitations on the types of comparison that can be undertaken, the central conflict between best practice for an individual and trial protocols, problems of applicability to the general population and applicability of work done on one population to another, type II errors, publication bias, misuse and limitation of statistics, fraud, maintenance of blinding, asking the wrong question, and a simplistic, reductionist view of clinical management. The concentration on the randomised, controlled trial devalues information from other sources, such as natural history studies, clinical experience and case reports. The randomised, controlled trial is an important source of information and as physicians we should welcome more well-crafted trials, but they are not the only source of information.

Controlled Clinical Trials as Topic↗