A meta-epidemiological study of bias in randomized clinical trials of open and laparoscopic surgery.

BACKGROUND: Blinding, random sequence generation, and allocation concealment are established strategies to minimize bias in RCTs. Meta-epidemiological studies of drug trials have demonstrated exaggerated treatment effects in RCTs where such methods were not employed. As blinding is more difficult in surgical trials it is important to determine whether this applies to them. The study aimed to investigate this using systematic meta-epidemiological methods. METHOD: The Cochrane Database of Systematic Reviews was searched for systematic reviews of RCTs that compared laparoscopic and open abdominal surgical procedures. Each review was then scrutinized to determine whether at least one of the included trials was blinded. Eligible reviews were updated and individual RCTs retrieved. Extracted data included the primary outcomes of interest (length of stay and complications), secondary outcomes and a risk of bias assessment. A multistep meta-regression analysis was then performed to obtain an overall difference in the reported outcome differences between trials that employed each bias-minimization strategy, and those that did not. RESULTS: Some 316 RCTs were included, reporting on eight different procedures. Patient-blinded RCTs reported a smaller difference in length of stay between laparoscopic and open groups (difference of standardized mean differences -0·36 (95 per cent c.i. -0·73 to 0·00)) and complications (ratio of odds ratios 0·76 (95 per cent c.i. 0·61 to 0·93)). Blinding of postoperative carers and outcome assessors had similar effects. CONCLUSION: Lack of blinding significantly altered the treatment effect estimates of RCTs comparing laparoscopic and open surgery. Blinding should be implemented in surgical RCTs where possible to avoid systematic bias.

Malaysian consensus statement on FDG PET-CT reporting format for lymphoma.

Over the past decade, 18F-Fluorodeoxyglucose (FDG) positron emission tomography-computed tomography (PETCT) has emerged as an important imaging modality in the management of lymphoma. Since the introduction of Deauville scoring system (2009) and the Lymphoma Response Assessment Criteria (2014), clinicians are now sharing a common language in the management of lymphoma. In Malaysia, nearly a third of PET-CT request is related to lymphoma imaging. Though there are extensive publications regarding these scoring systems and assessment criteria for lymphoma, there are hardly any literature on the reporting format for the 18F-FDG PET-CT in this disease. The variable reporting formats have on many occasions caused confusion not only to the referring clinicians but also to nuclear medicine physicians. Thus, a working committee comprising experienced nuclear medicine physicians and haematologists in Malaysia have agreed and made a joint recommendation on the standard reporting format for 18F-FDG PET-CT in Lymphoma. This recommendation will minimize inter-observer discrepancies in reporting, facilitate the understanding of the report of the referring clinicians as well as facilitate counseling between patients and clinicians in the management of the disease.

Network meta-analysis of surgical management of gastro-oesophageal reflux disease in adults.

BACKGROUND: Proton pump inhibitors are the mainstay of treatment for gastro-oesophageal reflux disease, but are associated with ongoing costs and side-effects. Antireflux surgery is cost-effective and is preferred by many patients. A total (360o or Nissen) fundoplication is the traditional procedure, but other variations including partial fundoplications are also commonly performed, with the aim of achieving durable reflux control with minimal dysphagia. Many RCTs and some pairwise meta-analyses have compared some of these procedures but there is still uncertainty about which, if any, is superior. Network meta-analysis allows multiple simultaneous comparisons and robust synthesis of the available evidence in these situations. A network meta-analysis comparing all antireflux procedures was performed to identify which has the most favourable outcomes at short-term (3-12 months), medium-term (1-5 years) and long-term (10 years and more than 10 years) follow-up. METHODS: Article databases were searched systematically for all eligible RCTs. Primary outcomes were quality-of-life measures and dysphagia. Secondary outcomes included reflux symptoms, pH studies and complications. RESULTS: Fifty-one RCTs were included, involving 5357 patients and 14 different treatments. Posterior partial fundoplication ranked best in terms of reflux symptoms, and caused less dysphagia than most other interventions including Nissen fundoplication. This was consistent across all time points and outcome measures. CONCLUSION: Posterior partial fundoplication provides the best balance of long-term, durable reflux control with less dysphagia, compared with other treatments.

Analysis of TP53 gene expression and p53 level of human hypopharyngeal FaDu (HTB-43) head and neck cancer cell line after microRNA-181a inhibition.

The identification of new biomarkers for early detection of highly recurrent head and neck cancer is urgently needed. MicroRNAs (miRNAs) are small and non-coding RNAs that regulate cancer-related gene expression, such as tumor protein 53 (TP53) gene expression. This study was carried out to analyze TP53 gene expression using real-time PCR and to determine changes in intracellular p53 level by flow cytometry after downregulation of miRNA-181a miRNA inhibitor in the FaDu cell line. TP53 gene expression showed a 3-fold increment and the p53 protein level was also increased in the miRNA-181a-treated cells. In conclusion, miRNA-181a binds to the TP53 gene and inhibits its expression, decreasing the synthesis of p53.