Comparison of reports of randomized controlled trials and systematic reviews in surgical journals: literature review

OBJECTIVES: Randomized controlled trials and systematic reviews of such trials are the gold standard for assessing the effectiveness of interventions. There have been concerns about the anecdotal evidence underpinning many of the interventions used and introduced into surgical care. The American College of Surgeons has prioritized the need for more trials and systematic reviews of trials. To investigate the assertion that the methodological quality of studies conducted in surgery is in general poor and to assess the possible impact of new policy developments in the US, we sought to compare the number and proportion of published randomized controlled trials and systematic reviews in the leading two US and UK general surgical journals. Two reviewers systematically and independently hand searched all issues of these journals over a 12-month period to identify randomised controlled trials and systematic reviews. DESIGN: Systematic searching and independent abstraction of data from all volumes of the top two general surgical journals published in the USA and the UK in 2004. SETTING: 519 original reports in UK journals and 616 original reports in USA journals. MAIN OUTCOME MEASURES: Number and proportion of randomized controlled trials and systematic reviews. RESULTS: Overall, the proportion of randomized controlled trials in all four journals was 5.6% (95% confidence interval [CI] 4.4-7.0) and 5.2% (95% CI 4.1-6.7) for systematic reviews. For journals published in the UK 29/519 (5.6%) of the publications were reports of randomized controlled trials, and for the USA journals this figure was 34/616 (5.5%); odds ratio [OR]=0.99, 95%CI 0.6-1.6; P=0.96. Systematic reviews were significantly more commonly reported in the UK journals: UK 37/519 (7.1%) versus USA 22/616 (3.6%); OR=0.48, 95%CI 0.3-0.8; P<0.01. CONCLUSIONS: The concerns expressed almost a decade ago remain valid: there are still very few reports of randomized controlled trials and systematic reviews published in leading USA and UK surgical journals, with relatively little difference between these countries in the proportion of reported studies employing these designs. The American College of Surgeons initiative has yet to make an impact.     

Does Serum Procalcitonin Have a Role in Evaluating the Severity of Acute Pancreatitis? A Question Revisited

Purpose This study was designed to evaluate the diagnostic accuracy of serum procalcitonin (PCT) for the diagnosis of severity in acute pancreatitis (AP), compared with routine clinical, biochemical, radiological, and combination severity scoring systems. Methods Quantitative meta-analysis was performed on prospective studies, comparing serum PCT, against validated scoring systems for diagnosing severe AP. The sensitivity, specificity, and diagnostic odds ratio were calculated for each study. Summary receiver operating characteristic (SROC) curves and subgroup analysis were undertaken. Study quality and heterogeneity were evaluated. Meta-regression meta-analysis was used to evaluate the effect of using serum PCT in the diagnostic accuracy severity scoring in AP. Results Summary receiver operating characteristic analysis of nine studies showed an overall sensitivity and specificity of 74% (range: 66%–81%) and 83% (range: 79%–87%), respectively. Overall unweighted area under the curve (AUC) was 0.91 (DOR = 16.26 95% CI: 5.68–46.60), demonstrating significant heterogeneity (Q-value = 25.32; P = 0.001). When high-quality studies alone were evaluated, there was an increase in the overall sensitivity (89%); however, specificity was similar (82%), with an overall unweighted AUC of 0.94 (DOR 41.46, 95% CI: 17.95–95.80), with no significant heterogeneity. Meta-regression analysis confirmed the significant effect of study quality on the diagnostic accuracy of severity scoring using serum PCT (P = 0.025). Conclusions The use of PCT for severity scoring in AP has a moderate sensitivity but higher specificity. However, the overall accuracy for predicting severity in AP is high. The prognosis of severity, especially early on (<48 hours from onset of symptoms), and the evaluation of potential infectious complications of AP may be the most useful factors to assess in subsequent clinical trials to identify its exact application in clinical practice in the management of AP.     

Handheld computers and the 21<Superscript>st</Superscript> century surgical team: a pilot study

Background  

The commercial development and expansion of mobile phone networks has led to the creation of devices combining mobile phones and personal digital assistants, which could prove invaluable in a clinical setting. This pilot study aimed to look at how one such device compared with the current pager system in facilitating inter-professional communication in a hospital clinical team.     

Germline mosaicism of PHOX2B mutation accounts for familial recurrence of congenital central hypoventilation syndrome (CCHS)

Congenital central hypoventilation syndrome (CCHS), a rare disorder characterized by alveolar hypoventilation and autonomic dysregulation, is caused by mutations in the PHOX2B gene. Most mutations occur de novo, but recent evidence suggests that up to 25% are inherited from asymptomatic parents with somatic mosaicism for these mutations. However, to date, germline mosaicism has not been reported. This report describes a family with recurrence of PHOX2B mutation-confirmed CCHS due to germline mosaicism. The first occurrence was a baby girl, noted on day 2 of life to have multiple episodes of apnea, bradycardia, and cyanosis while breathing room air. PHOX2B gene testing confirmed the diagnosis of CCHS with a heterozygous polyalanine repeat expansion mutation (PARM); genotype 20/27 (normal 20/20). Both parents tested negative for this mutation using fragment analysis (limit of detection <1%). Upon subsequent pregnancy [paternity confirmed using short tandem repeat (STR) analysis], amniocentesis testing identified the PHOX2B 20/27 genotype, confirmed with repeat testing. Elective abortion was performed at 21.5 weeks gestation. Testing of abortus tissue confirmed amniocentesis testing. The PHOX2B 20/27 expansion was not observed in a paternal sperm sample. This case represents the first reported family with recurrence of PHOX2B mutation-confirmed CCHS without detection of a parental carrier state or mosaicism, confirming the previously hypothesized possibility of germline mosaicism for PHOX2B mutations. This is an important finding for genetic counseling of CCHS families, suggesting that even if somatic mosaicism is not detected in parental samples, there is still reason for careful genetic counseling and consideration of prenatal testing during subsequent pregnancies. ? 2012 Wiley Periodicals, Inc.     

Use of anti‐CD20 antibody in the treatment of post‐transplant glomerulonephritis

Damodar A, Mustafa R, Bhatnagar J, Panesar M, Gundroo A, Zachariah M, Blessios G, Tornatore K, Weber‐Shrikant E, Venuto R. Use of anti‐CD20 antibody in the treatment of post‐transplant glomerulonephritis.
Clin Transplant 2011: 25: 375–379. © 2010 John Wiley & Sons A/S. Abstract: Post‐transplant glomerulonephritis (PTGN) accounts for 4–10% of late graft loss. Six consecutive patients who developed PTGN 3–72 months post‐transplant presented to our center with deteriorating kidney function and proteinuria. Three had focal segmental glomerulosclerosis; one had membranoproliferative glomerulonephritis Type 1; one recurrent membranous nephropathy; and one recurrent immunoglobin A nephropathy. All six were treated with an aggressive immunosuppression regimen including rituximab, pulse steriods and/or maximization of mycophenolic acid and calcineurin inhibitor therapy. Four of the six patients received plasma exchange. The patients were followed for a minimum of nine months after treatment. Proteinuria decreased from 7.2 ± 4.4 to 1.4 ± 1.5 g (p = 0.04), while mean estimated glomerular filtration rate was 31.2 ± 13.1 and 42.5 ± 21.7 mL/min (p = 0.07) at nine months. No adverse events were noted. These observations suggest that immune modulating therapy may be of benefit in the treatment of PTGN.     

Behavioural interventions for smoking cessation in patients hospitalised for a major cardiovascular event

The impact of cigarette smoking on progression of atherosclerosis in patients with known cardiovascular disease suggests a strong need for effective cessation interventions in this group. This letter compares and discusses smoking cessation outcomes following behavioural smoking cessation interventions versus usual care in hospitalised cardiovascular patients using meta-analysis of randomised controlled peer-reviewed publications. It particularly focuses on the impact of intensity and duration of intervention on outcome.