A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials

<p>Abstract</p> <p>Background</p> <p>Decisions about interim analysis and early stopping of clinical trials, as based on recommendations of Data Monitoring Committees (DMCs), have far reaching consequences for the scientific validity and clinical impact of a trial. Our aim was to evaluate the frequency and quality of the reporting on DMC composition and roles, interim analysis and early termination in pediatric trials.</p> <p>Methods</p> <p>We conducted a systematic review of randomized controlled clinical trials published from 2005 to 2007 in a sample of four general and four pediatric journals. We used full-text databases to identify trials which reported on DMCs, interim analysis or early termination, and included children or adolescents. Information was extracted on general trial characteristics, risk of bias, and a set of parameters regarding DMC composition and roles, interim analysis and early termination.</p> <p>Results</p> <p>110 of the 648 pediatric trials in this sample (17%) reported on DMC or interim analysis or early stopping, and were included; 68 from general and 42 from pediatric journals. The presence of DMCs was reported in 89 of the 110 included trials (81%); 62 papers, including 46 of the 89 that reported on DMCs (52%), also presented information about interim analysis. No paper adequately reported all DMC parameters, and nine (15%) reported all interim analysis details. Of 32 trials which terminated early, 22 (69%) did not report predefined stopping guidelines and 15 (47%) did not provide information on statistical monitoring methods.</p> <p>Conclusions</p> <p>Reporting on DMC composition and roles, on interim analysis results and on early termination of pediatric trials is incomplete and heterogeneous. We propose a minimal set of reporting parameters that will allow the reader to assess the validity of trial results.</p

Comparison of modified ultrafast Papanicolaou stain with the standard rapid Papanicolaou stain in cytology of various organs

Background: Since the first introduction of Papanicolaou (Pap) stain in 1942 there have been many modifications. Of these, the Ultra-Fast Pap stain has become popular. This technique was further modified in India as many of the reagents were not available in our country. Our study was conducted by adapting this modified staining technique which involves the replacement of Gill′s hematoxylin with Harris hematoxylin. Aims: The aim of our prospective study was to assess the use of the modified Ultra-Fast Pap stain (MUFP) for fine needle aspiration cytology (FNAC) of various organs in comparison with the standard rapid Pap stain. Materials and Methods: A total of 100 FNAC cases were studied by random sampling. Two smears were prepared for each case and stained by both, the MUFP and the rapid Pap stain. Scores were given and the quality index was calculated, followed by the statistical analysis. The number of cases was as follows: lymph node (43), thyroid (25), breast (23), salivary gland (02), and soft tissues (07). Scores were given on four parameters: Background of smears, overall staining pattern, cell morphology and nuclear staining. Quality index was calculated from the ratio of score achieved to the maximum score possible. Statistical Analysis: Results were analyzed using Mean, Median, Standard Deviation, ′t′ paired test, ′P′ value and M-diff for statistical significance. Results: Correct diagnosis was made in all cases. The quality index of MUFP smears was better compared to the rapid Pap stain in all the organs, and was statistically significant. MUFP smears showed a clear red blood cells background, transparent cytoplasm and crisp nuclear features. Conclusion: MUFP is a reliable and rapid technique for cytology diagnosis