Article type
Year
Abstract
Background: Children are often excluded from randomised controlled trials (RCTs) therefore clinically important questions may need to be extrapolated from research in adults. Up to now there have been no comprehensive evidence-based guidelines on how to manage type 1 diabetes in children, although previous evidence based guidelines exist in adults and a consensus guideline in children has been used widely. An evidence-based guideline for England and Wales was commissioned by the National Institute for Clinical Excellence and is due to be published in 2004.
Objectives: To review the quality of evidence relating to the management of type 1 diabetes in children, to identify areas where studies involved children and identify where recommendations were based on research extrapolated from adults.
Results: Of the 136 recommendations for the diagnosis and management of type 1 diabetes in children only a minority of recommendations were based on RCTs that had included children.
Overall only one recommendation was derived from a systematic review of RCTs that included children and 10 (7.3%) recommendations were derived from RCTs involving children. Most of the RCTs we identified related to insulin preparations and delivery devices, and many of these RCTs were funded by pharmaceutical companies.
A further 12 (8.8%) recommendations were derived from at least one controlled study without randomisation involving children, or by extrapolating evidence from RCTs involving adults. Sixteen (11.8%) recommendations were based on observational studies. The majority, 92 (67.7%) recommendations, were derived from the consensus view of the Guideline Development Group and expert opinion. Five recommendations (3.7%) were taken from a National Institute for Clinical Excellence Technology Appraisal.
The proportion of recommendations based on systemic reviews and RCTs is lower than in guidelines for antenatal care or management of infertility.
RCTs that involve children with type 1 diabetes are needed to evaluate the clinical and cost effectiveness of many areas including; education programmes, intensive insulin management, diabetic ketoacidosis management and behavioural and social interventions.
Conclusion: There is a lack of good-quality RCTs and systematic reviews examining the management of type 1 diabetes in children, compared to the evidence available for adults. Gaps in the evidence base were filled with low quality studies, consensus from health care professionals and data extrapolated from adult studies.
The gaps in the evidence base could be related to the fact that outcomes of interest such as long-term complications require extended study periods, expensive study designs and such studies may incur problems with rapidly changing technology. In common with other studies involving children, there may be difficulty in recruiting sufficient participants to ensure adequate study power. To improve the evidence base for care of children with type 1 diabetes we need to improve study design, analysis and reporting and to encourage publication in peer reviewed journals.
Objectives: To review the quality of evidence relating to the management of type 1 diabetes in children, to identify areas where studies involved children and identify where recommendations were based on research extrapolated from adults.
Results: Of the 136 recommendations for the diagnosis and management of type 1 diabetes in children only a minority of recommendations were based on RCTs that had included children.
Overall only one recommendation was derived from a systematic review of RCTs that included children and 10 (7.3%) recommendations were derived from RCTs involving children. Most of the RCTs we identified related to insulin preparations and delivery devices, and many of these RCTs were funded by pharmaceutical companies.
A further 12 (8.8%) recommendations were derived from at least one controlled study without randomisation involving children, or by extrapolating evidence from RCTs involving adults. Sixteen (11.8%) recommendations were based on observational studies. The majority, 92 (67.7%) recommendations, were derived from the consensus view of the Guideline Development Group and expert opinion. Five recommendations (3.7%) were taken from a National Institute for Clinical Excellence Technology Appraisal.
The proportion of recommendations based on systemic reviews and RCTs is lower than in guidelines for antenatal care or management of infertility.
RCTs that involve children with type 1 diabetes are needed to evaluate the clinical and cost effectiveness of many areas including; education programmes, intensive insulin management, diabetic ketoacidosis management and behavioural and social interventions.
Conclusion: There is a lack of good-quality RCTs and systematic reviews examining the management of type 1 diabetes in children, compared to the evidence available for adults. Gaps in the evidence base were filled with low quality studies, consensus from health care professionals and data extrapolated from adult studies.
The gaps in the evidence base could be related to the fact that outcomes of interest such as long-term complications require extended study periods, expensive study designs and such studies may incur problems with rapidly changing technology. In common with other studies involving children, there may be difficulty in recruiting sufficient participants to ensure adequate study power. To improve the evidence base for care of children with type 1 diabetes we need to improve study design, analysis and reporting and to encourage publication in peer reviewed journals.