Clinical trials published in Revista Española de Anestesiología y Reanimación: characteristics and quality of design

OBJECTIVE: To identify and assess the quality of controlled clinical trials published in Revista Espa?ola de Anestesiología y Reanimación during the period 1967-2004. MATERIAL AND METHODS: We identified and classified clinical trials following the criteria adopted by the International Cochrane Collaboration. Each trial was described and its design assessed. RESULTS: We identified 640 controlled clinical trials: 233 (36.4%) were published as original articles, 398 (62.2%) were conference presentations, and 9 (1.4%) were in other publication formats. The most common type of trial design, found in 398 (62.2%) cases, was drug-to-drug comparison. The main outcome was of clinical interest in 464 (72.5%) cases. The system of randomization used was considered adequate in only 37 (5.8%) of the studies. The funding source for 432 (67.5%) trials was not specified. CONCLUSIONS: It is noteworthy that Revista Espa?ola de Anestesiología y Reanimación has published a large number of controlled clinical trials in comparison with other Spanish journals covered by Index Medicus. We observed that important information on how the trials were carried out was missing and that trial quality was low in terms of current standards. The editorial board's adoption of the CONSORT statement may help to improve the quality of trials currently being published, and that question should be analyzed after a reasonable period of time has passed.     

Controlled clinical trials in cystic fibrosis--are we doing better?

We have previously reported the time trends, design and interventions in randomised controlled trials (RCTs) in cystic fibrosis (CF) from 1961 through 1997 [Cheng K, Smyth RL, Motley J, O'Hea U, Ashby D, Randomised controlled trials in cystic fibrosis (1966-1997) categorized by time, design, and intervention. Pediatr Pulmonol 2000, 29:1-7.]. We maintain an ongoing register of all RCTs and controlled clinical trials (CCTs) in CF and have noted that in the five years since 1997 there has been a 48% increase in published trials. We aimed to assess whether this increase has been associated with an improvement in design quality. All RCTs and CCTs from 1961-2002 were assessed. Two epochs were then compared, 1961-1997 and 1998-2002. For each trial we recorded the design, participant numbers and the intervention studied. 261 trials in 1998-2002 were compared with 544 trials in 1961-1997. Comparing the two epochs a similar proportion of trials were parallel, double-blind and placebo controlled; also the median number of participants was similar. In the later epoch 25% of trials were multicentre, compared with 11% previously. Whilst this recent increase in clinical trials in CF is welcome, this has not been associated with improvements in quality. The trend for an increasing proportion of trials to be multicentre is encouraging. There are however, still deficiencies in the design of clinical trials in CF.     

A bibliography of articles on the history of anaesthesia and medicine in Anaesthesia and Intensive Care 1972-2005

This bibliography references all articles on the history of anaesthesia and medicine published in Anaesthesia and Intensive Care from volume 1 in 1972 to 34 years later when the first symposium on Anaesthesia History was published in the June issue of the Journal (Vol 33, 2005).     

On bias

We performed a search in Medline to assess the quality of clinical journals in orthopedics from the point of view of study design. 3 levels of quality were chosen: prospective studies, random allocation or double-blind methods and randomized controlled trials; all entries were Medical Subject Headings (MeSH).

Out of 25,538 articles indexed in Medline since 1966-1993 in the 8 most cited general orthopedic journals, 994 were indexed as prospective studies, while 138 were indexed as randomized, controlled trials. In recent years the number of well-designed articles has increased, as has the percentage. In a random check of 208 articles, approximately half were of a clinical type where these issues can be addressed. The agreement between the manual check and Medline indexing was good, but not perfect.

It was concluded that the retrospective study representing clinical production control accounts for the vast majority of all published clinical articles in orthopedics. In recent years, a sharp increase in controlled trials had, however, occurred.     

Chiropractic care for patients with asthma: A systematic review of the literature

Objective:

To provide a review of the literature and rate the quality of published studies regarding chiropractic care, including spinal manipulation, for asthmatic patients.

Methods:

A multimodal search strategy was conducted, including multiple database searches, along with reference and journal hand-searching. Studies were limited to those published in English and in peer-reviewed journals or conference proceedings between January 1980 and March 2009. All study designs were considered except personal narratives or reviews. Retrieved articles that met the inclusion criteria were rated for quality by using the Downs and Black checklist. A brief summary was also written for each retrieved study.

Results:

Eight articles met the inclusion criteria of this review in the form of one case series, one case study, one survey, two randomized controlled trials (RCTs), one randomized patient and observer blinded cross-over trial, one single blind cross study design, and one self-reported impairment questionnaire. Their quality scores ranged from 5 to 22 out of 27.

Conclusion:

Results of the eight retrieved studies indicated that chiropractic care showed improvements in subjective measures and, to a lesser degree objective measures, none of which were statistically significant. It is evident that some asthmatic patients may benefit from this treatment approach; however, at this time, the evidence suggests chiropractic care should be used as an adjunct, not a replacement, to traditional medical therapy.     

Controlled Trials in Aesthetic Plastic Surgery: A 16-Year Analysis

Aesthetic surgery is one pillar of plastic surgery. Thus, not surprisingly, journals exist that focus predominantly on advances within this subspecialty. However, rarely has the process of systematic reviewing that identified randomized controlled trials (RCTs) and controlled clinical trials (CCTs) been conducted within this subspecialty. All original articles published in Aesthetic Plastic Surgery were analyzed to identify all RCTs and CCTs. The proportion of RCTs and CCTs in all original articles was determined, and the quality of reporting was assessed on the basis of established quality items. Additional parameters were investigated including reporting of statistically significant differences, type of institution, and country affiliation of the first author. Of the 1,048 original articles analyzed, 11 (1%) and 24 (2.3%) articles met the inclusion criteria for RCTs and CCTs, respectively. Only two studies were single blinded, whereas only one study reported on successful double blinding and appropriate allocation concealment. Notably, these trials were RCTs. Participant dropout was reported in one study. Statistically significant differences were reported in 18 trials, 6 of which were RCTs. The annual publication of RCTs has increased over the past 5 years. North America and Europe contributed a total of 28 controlled trials (80%). Controlled trials are being conducted in aesthetic surgery at a strikingly low rate. However, a recent increase in published RCTs reflects the recognition that performing outcome studies is pivotal in moving practice toward a foundation based on assessment by outcome. The quality of reporting, however, needs improvement.     

Quality of complication reporting in the surgical literature

OBJECTIVE: To identify 10 critical elements of accurate and comprehensive reports of surgical complications. SUMMARY BACKGROUND DATA: Despite a venerable tradition of weekly morbidity and mortality conferences, inconsistent complication reporting is common in the surgical literature. METHODS: An analysis of articles reporting short-term outcomes after pancreatectomy, esophagectomy, and hepatectomy was performed. Randomized clinical trials (RCTs) published from 1975 to 2001 and retrospective series of more than 100 patients published from 1990 to 2001 were reviewed. RESULTS: A total of 119 articles reporting outcomes in 22,530 patients were analyzed. This included 42 RCTs and 77 retrospective series. Of the 10 criteria developed, no articles met all criteria; 2% met 9 criteria, 38% 7 or 8, 34% 5 or 6, 40% 3 or 4, and 12% 1 or 2. Outpatient information (22% of articles), definitions of complications provided (34% of articles), severity grade used (20% of articles), and risk factors included in analysis (29% of articles) were the most commonly unmet quality reporting criteria. Type of study (RCT vs. retrospective), site of institution (U.S. vs. non-U.S.) and journal (U.S. vs. non-U.S.) did not influence the quality of complication reporting. CONCLUSIONS: Short-term surgical outcomes are routinely included in the data reported in the surgical literature. This is often used to show improvements over time or to assess the impact of therapeutic changes on patient outcome. The inconsistency of reporting and the lack of accepted principles of accrual, display, and analysis of complication data argue strongly for the creation and generalized use of standards for reporting this information.     

Scientific publications in international anaesthesiology journals: a 10-year survey

Significant growth has been seen in the field of anaesthesiology in recent decades. The current geographic distribution of the publications on anaesthesia research may be different from ten years ago. We performed this literature survey to examine the national origin of articles published in international anaesthesiology journals and to evaluate their contribution to anaesthesia research. Articles published in 18 major anaesthesiology journals from 2000 to 2009 were identified from the PubMed database and the Science Citation Index. A total of 30,191 articles were published in the selected 18 journals from 2000 to 2009. The country responsible for the largest number of articles was the United States of America (29.4%), followed by the United Kingdom, Germany, Japan, Canada, Australia and France. Denmark, Switzerland and Finland had the largest number of articles per capita. Anesthesia & Analgesia published the most number of articles from 2000 to 2009, followed by Anesthesiology, Pain and the British Journal of Anaesthesia. The numbers of clinical studies and randomised controlled trials decreased markedly from 2000 to 2009.     

An evaluation of the quality of clinical trials in anesthesia.

BACKGROUND: The authors evaluated the quality of clinical trials published in four anesthesia journals during the 20-yr period from 1981-2000. METHODS: Trials published in four major anesthesia journals during the periods 1981-1985, 1991-1995, and the first 6 months of 2000 were grouped according to journal and year. Using random number tables, four trials were selected from all of the eligible clinical trials in each journal in each year for the periods 1981-1985 and 1991-1995, and five trials were selected from all of the trials in each journal in the first 6 months of 2000. Methods and results sections from the 160 trials from 1981-1985 and 1991-1995 were randomly ordered and distributed to three of the authors for blinded review of the quality of the study design according to 10 predetermined criteria (weighted equally, maximum score of 10): informed consent and ethics approval, eligibility criteria, sample size calculation, random allocation, method of randomization, blind assessment of outcome, adverse outcomes, statistical analysis, type I error, and type II error. After these trials were evaluated, 20 trials from the first 6 months of 2000 were randomly ordered, distributed, and evaluated as described. RESULTS: The mean (+/- SD) analysis scores pooled for the four journals increased from 5.5 +/- 1.4 in 1981-1985 to 7.0 +/- 1.1 in 1991-1995 (P < 0.00001) and to 7.8 +/- 1.5 in 2000. For 7 of the 10 criteria, the percentage of trials from the four journals that fulfilled the criteria increased significantly between 1981-1985 and 1991-1995. During the 20-yr period, the reporting of sample size calculation and method of randomization increased threefold to fourfold, whereas the frequency of type I statistical errors remained unchanged. CONCLUSION: Although the quality of clinical trials in four major anesthesia journals has increased steadily during the past two decades, specific areas of trial methodology require further attention.     

The effectiveness of therapeutic ultrasound for musculoskeletal conditions of the lower limb: A literature review

BackgroundUltrasound is suggested as one of the treatment options available for soft tissue musculoskeletal conditions of the lower limb and to this end, the objective was to review the literature and evaluate the effectiveness of therapeutic ultrasound for musculoskeletal conditions of the lower limb.MethodsA search of the literature published between 1975 and February 2009 was carried out. All studies that fulfilled the inclusion criteria were quality assessed and scored using the Critical Appraisal Skills Programme (CASP) appraisal tool [1] for randomised controlled trials.ResultsTen studies out of a possible fifteen were included in the review. Only one trial was considered to be high quality (score 16+), three medium quality trials (score 11–15) were identified and six trials were considered to be low or poor quality (score ≤ 10). None of the six placebo-controlled trials found any statistically significant differences between true and sham ultrasound therapy.ConclusionThis literature review found that there is currently no high quality evidence available to suggest that therapeutic ultrasound is effective for musculoskeletal conditions of the lower limb.     

An evaluation of conscious sedation using propofol and remifentanil for tension-free vaginal tape insertion

Tension-free vaginal tape insertion is a recommended treatment for stress incontinence. There is evidence that intra-operative testing of continence by asking patients to cough may improve outcomes, but an optimal sedation regimen has not been determined. We prospectively evaluated the effectiveness of propofol and remifentanil infusions in 25 patients using pre- and post-sedation peak cough pressures and pain scores. Patient satisfaction was assessed using the Iowa Satisfaction with Anaesthesia Score (ISAS). Post-sedation cough pressures were improved compared to baseline, with a mean peak pressure increase of 24 mmHg (95% CI 15.5–32.5; p   <   0.001). Pain scores (median, IQR [range]) were low for local anaesthetic infiltration (0, [0–1]) and first (0, [0–1]) and second (0, [0–3.5]) needle insertions. Of the 19 patients completing the ISAS, all felt safe and satisfied. Sedation using propofol and remifentanil provides acceptable analgesia, satisfaction and effective continence testing.     

The quality of randomized controlled trials in major anesthesiology journals

Increased attention has been directed at the quality of randomized controlled trials (RCTs) and how they are being reported. We examined leading anesthesiology journals to identify if there were specific areas for improvement in the design and analysis of published clinical studies. All RCTs that appeared between January 2000 and December 2000 in leading anesthesiology journals (Anesthesiology,Anesthesia & Analgesia,Anaesthesia, and Canadian Journal of Anaesthesia) were retrieved by a MEDLINE search. We used a previously validated assessment tool, including 14 items associated with study quality, to determine a quality score for each article. The overall mean weighted quality score was 44% +/- 16%. Overall average scores were relatively high for appropriate controls (77% +/- 7%) and discussions of side effects (67% +/- 6%). Scores were very low for randomization blinding (5% +/- 2%), blinding observers to results (1% +/- 1%), and post-beta estimates (16% +/- 13%). Important pretreatment clinical predictors were absent in 32% of all studies. Significant improvement in the reporting and conduct of RCTs is required and should focus on randomization methodology, the blinding of investigators, and sample size estimates. Repeat assessments of the literature may improve the adoption of guidelines for the improvement of the quality of randomized controlled trials.     

Randomised clinical trials in plastic surgery: survey of output and quality of reporting.

Randomised clinical trials (RCTs) are considered the best level of evidence when evaluating interventions. Report quality is often used as a surrogate measure of methodological quality, with poorly reported trials assumed to be poorly conducted. To address this problem the CONsolidated Standards of Reporting Trials (CONSORT) statement was published, encouraging authors to explicitly report certain items of information. The aim of this study was to survey RCTs published in the plastic surgery literature and determine quality of reporting. All RCTs published in Plastic & Reconstructive Surgery, British Journal of Plastic Surgery and Annals of Plastic Surgery from 1980 to 2004 were retrieved using a Medline search. Quality of reporting was assessed using a 17-item checklist derived from the CONSORT statement. One hundred and thirty three trials were eligible for assessment. 56 (42.1%) originated from European countries. Anaesthesia/analgesia was the most popular topic addressed and accounted for 23 (17.3%) of all studies. Quality of reporting analysis revealed wide variation between items. Sample size calculation was only reported in 17(12.8%) trials. Randomisation methodology, allocation concealment and blind investigator/assessment was reported in 39 (29.3%), 25 (18.8%) and 69 (51.9%) trials respectively. Study limitations were also infrequently reported and present in only 45 (33.8%) trials. This study indicates the annual output of plastic surgery RCTs is increasing and a variety of topics are covered. However, reporting of certain key items is inadequate. Awareness of the CONSORT statement and more attention to the quality of reporting may improve matters.     

The role of prospective randomized clinical trials in pediatric surgery: state of the art?

PURPOSE: This study sought to determine the role of randomized controlled trials (RCT) in the evolution of pediatric surgical practice. METHODS: The authors used a computer-assisted literature search to identify all clinical trials related to pediatric surgery published in the English-language literature from 1966 through 1999. Each article was reviewed in detail for purpose, content, conduct, and quality of the trial. The authors assessed quality with a previously validated instrument (Chalmers Qualitative Assessment). RESULTS: The authors identified 134 RCTs related to pediatric surgery over the past 33 years. This accounts for 0.17% of 80,377 articles published in the field. The areas of surgery studied were analgesia 65 (49%), antibiotics 17 (13%), extracorporeal membrane oxygenation (ECMO) 9 (7%), gastrointestinal, burns, oncology, minimally invasive surgery, vascular access, congenital anomalies, and trauma (each <5%). Only 16 (12%) trials compared 2 surgical therapies, 9 (7%) compared a medical versus a surgical therapy, and 109 (81%) compared 2 medical therapies in surgical patients. Fourteen (10%) RCTs were funded by peer-reviewed agencies. Only 17 (13%) RCTs included a biostatistician as an author or a consultant. Trial design included calculation of sample size and statistical power in 21 (16%) RCTs. Method of randomization was reported in only 51 (38%). The test statistic and observed probability value was reported in 15 (11%). CONCLUSIONS: Clinical trials are used infrequently to answer questions related to pediatric surgery. When RCTs are utilized, they often suffer from poor trial design, inadequate statistical analysis, and incomplete reporting. Pediatric surgery could benefit from increased expertise, funding, and participation in clinical trials.     

Randomized controlled trials in neurosurgery—how good are we?

Summary Background  The strongest evidence in medical clinical literature is represented by randomized controlled trials (RCTs). This study was designed to evaluate neurosurgically relevant RCTs published recently by neurosurgeons. Method  A literature search in MEDLINE and EMBASE included all clinical studies published up to 30 June 2006. RCTs with neurosurgical relevance published by at least one author with affiliation to a neurosurgical department were selected. The number and characteristics of individual trials were recorded, and the quality of the trials with regard to study design, quality of reporting, and relevance for clinical practice was assessed by two different investigators using a modification of the Scottish Intercollegiate Guidelines Network methodology checklist. Changes of RCT quality over time as well as factors influencing the quality were analyzed. Findings  From the initial search results (MEDLINE n = 3,860, EMBASE n = 3,113 articles), 159 RCTs published by neurosurgeons were extracted for final evaluation. Of the RCTs, 62% have been published since 1995; 52% came from the USA, UK, and Germany. The median RCT sample size was 78 patients and the median follow-up 35.7 weeks. Fifty-two percent of all RCTs were of good, 37% of moderate, and 11% of bad quality, with an improvement over time. RCTs with financial funding and RCTs with a sample size of >78 patients were of significantly better quality. There were no major differences in the rating of the studies between the two investigators. Conclusions  Only a fraction of neurosurgically relevant literature consists of RCTs, but the quality is satisfying and has significantly improved over the last years. An adequate sample size and sufficient financial support seem to be of substantial importance with regard to the quality of the study. Our data also show that by using a standardized checklist, the quality of trials can be reliably assessed by observers of different experience and educational levels.     

The number, quality, and coverage of randomized controlled trials in nephrology

Randomized controlled trials (RCT) are the optimal study design to answer intervention questions. The authors evaluated the number, quality, and coverage of RCT in nephrology. MEDLINE was searched using the relevant medical subject headings for nephrology and 12 major specialties in internal medicine, limited by "randomized controlled trial" as a publication type. A random selection of 160 RCT in nephrology (40 for each decade) published since 1966 and an additional 270 RCT from ongoing or published Cochrane systematic reviews in various areas of nephrology, dialysis, and transplantation were evaluated for quality of reporting using standard criteria. The number of RCT published in nephrology from 1966 to 2002 (2779) is fewer than all other specialties of internal medicine (range: 5335 in hematology to 27109 in cardiology) with the proportion of all citations which are RCT being the third lowest (1.15%). There has been an increase in both indices from 1966 to 1996, but not at a greater rate than other specialties, and there has been no increase over the past 5 yr. Some areas of nephrology, in particular glomerulonephritis, are clear outliers with very low numbers of RCT to guide clinical decision-making. Overall the quality of RCT reporting in nephrology is low and has not improved over the past 30 yr with unclear allocation concealment (89%), lack of reported blinding of outcome assessors (92%), and failure to perform "intention-to-treat analysis" (50%) particularly frequent. The challenges of improving the quality and quantity of trials in nephrology are substantial, but they can be overcome by using standard guidelines and checklists for trial reporting, greater attention to the trial methods and not just the results, involving experts in trial design and reporting, multicenter collaboration, and larger and simpler trials.     

Deliberate hypotension in orthopedic surgery reduces blood loss and transfusion requirements: A meta-analysis of randomized controlled trials

PURPOSE: To determine if deliberate hypotension decreases blood loss and transfusion requirements in patients undergoing orthopedic surgery, a systematic review of all randomized trials addressing this issue was undertaken. METHODS: Electronic databases, citations lists and review articles were searched for potential articles. Relevant articles met the following inclusion criteria: English language, humans undergoing orthopedic surgery, deliberate hypotension used by any method, intraoperative blood loss measured as an outcome, and the trial methodology being randomized and controlled. Four outcomes were analyzed, including estimated blood loss, blood transfused, surgery duration, and quality of the surgical field. For all analyses, the random-effects model was used. RESULTS: Seventeen articles met the inclusion criteria. The surgeries studied included total hip arthroplasty (seven), orthognathic surgery (eight), total knee arthroplasty (one) and spinal fusion (one). A total of 636 patients were randomized across all studies. For blood loss, the overall weighted mean difference favoured treatment, with a savings of about 287 mL of blood [95% confidence interval (CI): -447, -127]. The mean differences also showed a statistically significant benefit for deliberate hypotension in reducing transfusion requirements (-667 mL of blood transfused; 95% CI: -963, -370). Deliberate hypotension was not shown to reduce the duration of surgery (-1.9 min of surgery; 95% CI: -7.2, 3.5) or improve surgical conditions (surgical field quality rating -0.5; 95% CI: -1.1, 0.2). CONCLUSION: This review provides some support for the use of deliberate hypotension in reducing blood loss and transfusion requirements in orthopedic surgery, but these results are tempered by the small sample sizes and poor methodological quality of published studies.