Article type
Year
Abstract
Background: The Cochrane Child Health Field’s Trials Register contains
records of over 30,000 randomised controlled trials (RCTs) and clinical
controlled trials (CCTs) published from 1948 onwards. The contents of the
register allow analysis of the development of design and reporting of
paediatric trials. This will provide historical context and direction for future
research. Objectives: To describe trials in child health and to examine
trends over time in quantity, quality, publication and trial characteristics.
Methods: We selected a random sample of 588 trials published between
1948 and 2006. Sampling was stratified by year, with all studies published
prior to 1960 being automatically included, and all years from 1960 to
2006 being sampled (using simple random sampling) at 10 trials per year.
Data were extracted using a structured electronic form and included
characteristics of publication (e.g., year, type of journal, number of
authors); study design (e.g., CCT vs. RCT, cross-over vs. parallel); pediatric
subspecialty; study methods (e.g., ITT analysis, blinding); results (e.g.,
statistical significance, authors’ conclusions); and methodological quality.
For the final analysis, study characteristics will be analysed using
descriptive statistics. Trends over time will be assessed using regression
and time series analysis methods. Results: Preliminary results show
the sample is 66% RCTs and 34% CCTs. Between 1948 and 1960, the
proportion of RCTs was 25%; between 1997 and 2006, 95%. The
percentage of multi-centered trials has increased, between these same
time periods, from 14% to 40%. Overall the methodological quality based
on Jadad scores was 2 (IQR 1, 3); between 1948 and 1960 it was 1 (IQR
0,2) and between 1997 and 2006, 2 (IQR 1,3). However, there were
persistent issues around methodological quality and reporting. Data
extraction and trend analyses will be complete for presentation at the
2008 Colloquium. Conclusions: Our completed work will outline the
characteristics of clinical trials conducted in pediatrics since 1948. We will
present this work in the context of the particular ethical, legal and practical
issues that are inherent to research among children.
records of over 30,000 randomised controlled trials (RCTs) and clinical
controlled trials (CCTs) published from 1948 onwards. The contents of the
register allow analysis of the development of design and reporting of
paediatric trials. This will provide historical context and direction for future
research. Objectives: To describe trials in child health and to examine
trends over time in quantity, quality, publication and trial characteristics.
Methods: We selected a random sample of 588 trials published between
1948 and 2006. Sampling was stratified by year, with all studies published
prior to 1960 being automatically included, and all years from 1960 to
2006 being sampled (using simple random sampling) at 10 trials per year.
Data were extracted using a structured electronic form and included
characteristics of publication (e.g., year, type of journal, number of
authors); study design (e.g., CCT vs. RCT, cross-over vs. parallel); pediatric
subspecialty; study methods (e.g., ITT analysis, blinding); results (e.g.,
statistical significance, authors’ conclusions); and methodological quality.
For the final analysis, study characteristics will be analysed using
descriptive statistics. Trends over time will be assessed using regression
and time series analysis methods. Results: Preliminary results show
the sample is 66% RCTs and 34% CCTs. Between 1948 and 1960, the
proportion of RCTs was 25%; between 1997 and 2006, 95%. The
percentage of multi-centered trials has increased, between these same
time periods, from 14% to 40%. Overall the methodological quality based
on Jadad scores was 2 (IQR 1, 3); between 1948 and 1960 it was 1 (IQR
0,2) and between 1997 and 2006, 2 (IQR 1,3). However, there were
persistent issues around methodological quality and reporting. Data
extraction and trend analyses will be complete for presentation at the
2008 Colloquium. Conclusions: Our completed work will outline the
characteristics of clinical trials conducted in pediatrics since 1948. We will
present this work in the context of the particular ethical, legal and practical
issues that are inherent to research among children.