|(4) Clinical genetic evaluation of the child with mental retardation or developmental delays. Moeschler JB, Shevell M, American Academy of Pediatrics Committee on Genetics.Pediatrics 2006 ;117(6):2304-16. |
Date Released 2006 Guideline Developer(s) American Academy of Pediatrics - Medical Specialty Society
Source(s) of Funding American Academy of Pediatrics
To provide recommendations for screening and management of late effects in survivors of pediatric malignancies
To increase quality of life and decrease complication-related healthcare costs for pediatric cancer survivors by providing standardized and enhanced follow-up care throughout the life-span that (a) promotes healthy lifestyles, (b) provides for ongoing monitoring of health status, (c) facilitates early identification of late effects, and (d) provides timely intervention for late effects
Asymptomatic survivors of childhood, adolescent, or young adult cancers who were treated surgically and who present for routine exposure-related medical follow-up
Interventions and Practices Considered
Thorough history and physical examination, and targeted screening evaluations
Major Outcomes Considered
Therapy-related complications or adverse effects that persist or arise after completion of treatment for a pediatric malignancy
Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)Hand-searches of Published Literature (Secondary Sources)
Description of Methods Used to Collect/Select the Evidence
Pertinent information from the published medical literature over the past 20 years (updated as of October 2008) was retrieved and reviewed during the development and updating of these guidelines. For each therapeutic exposure, a complete search was performed via MEDLINE (National Library of Medicine, Bethesda, MD). Keywords included "childhood cancer therapy," "complications," and "late effects," combined with keywords for each therapeutic exposure. References from the bibliographies of selected articles were used to broaden the search.
Number of Source Documents
Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus (Committee)
Rating Scheme for the Strength of the Evidence
"High-level evidence" was defined as evidence derived from high quality case control or cohort studies.
"Lower-level evidence" was defined as evidence derived from non-analytic studies, case reports, case series, and clinical experience.
Methods Used to Analyze the Evidence
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence
The guidelines were scored by the multidisciplinary panel of experts using a modified version of the National Criteria: Comprehensive Cancer Network "Categories of Consensus" system. Each score reflects the expert panel's assessment of the strength of data from the literature linking a specific late effect with a therapeutic exposure, coupled with an assessment of the appropriateness of the screening recommendation based on the expert panel's collective clinical experience. "High-level evidence" (category 1) was defined as evidence derived from high quality case control or cohort studies. "Lower-level evidence" (categories 2A and 2B) was defined as evidence derived from non-analytic studies, case reports, case series and clinical experience. Rather than submitting recommendations representing major disagreements, items scored as "Category 3" were either deleted or revised by the panel of experts to provide at least a "Category 2B" score for all recommendations included in the guidelines.
Methods Used to Formulate the Recommendations
Description of Methods Used to Formulate the Recommendations
In 2002, the leadership of the Children's Oncology Group (COG) Late Effects Committee and Nursing Discipline appointed a 7-member task force, with representation from the Late Effects Committee, Nursing Discipline, and Patient Advocacy Committee. The task force was convened to review and summarize the medical literature and develop a draft of clinical practice guidelines to direct long-term follow-up care for pediatric cancer survivors. The task force followed a modified version of the guideline development process established by the National Comprehensive Cancer Network (NCCN), integrating available literature with expert opinion using reiterative feedback loops.
The original draft went through several iterations within the task force prior to initial review. Multidisciplinary experts in the field, including nurses, physicians (pediatric oncologists and other subspecialists), patient advocates, behavioral specialists, and other healthcare professionals, were then recruited by the task force to provide an extensive, targeted review of the draft, including focused review of selected guideline sections. Revisions were made based on these recommendations. The revised draft was then sent out to additional multidisciplinary experts for further review. A total of 62 individuals participated in the review process. The guidelines subsequently underwent comprehensive review and scoring by a panel of experts in the late effects of pediatric malignancies, comprised of multidisciplinary representatives from the COG Late Effects Committee.
In order to keep the guidelines current and clinically meaningful, the COG Late Effects Committee organized 18 multi-disciplinary task forces in March 2004. These task forces were charged with the responsibility for monitoring the medical literature in regard to specific system-related clinical topics relevant to the guidelines (e.g., cardiovascular, neurocognitive, fertility/reproductive), providing periodic reports to the Late Effects Committee, and recommending revisions to the guidelines and their associated health education materials and references (including the addition of therapeutic exposures) as new information became available. Task force members were assigned according to their respective areas of expertise and clinical interest. A list of these task forces and their membership is included in the "Contributors" section of the original guideline document. The revisions incorporated into the previous (Version 2.0 – March 2006) and current (Version 3.0 – October 2008) release of these guidelines reflect the contributions and recommendations of these task forces.
All revisions proposed by the task forces were evaluated by a panel of experts, and if accepted, assigned a score (see "Rating Scheme for the Strength of the Evidence"). Proposed revisions that were rejected by the expert panel were returned with explanation to the relevant task force chair. If desired, task force chairs were given an opportunity to respond by providing additional justification and resubmitting the rejected task force recommendation(s) for further consideration by the expert panel. A total of 34 sections and 9 Health Links were added to Version 2.0 of these guidelines.
Rating Scheme for the Strength of the Recommendations
Each score relates to the strength of the association of the identified late effect with the specific therapeutic exposure based on current literature, and is coupled with a recommendation for periodic health screening based on the collective clinical experience of the panel of experts. This is due to the fact that there are no randomized clinical trials (and none forthcoming in the foreseeable future) on which to base recommendations for periodic screening evaluations in this population; therefore, the guidelines should not be misconstrued as representing conventional "evidence-based clinical practice guidelines" or "standards of care."
Each item was scored based on the level of evidence currently available to support it. Scores were assigned according to a modified version of the National Comprehensive Cancer Network "Categories of Consensus," as follows:CategoryStatement of Consensus1There is uniform consensus of the panel that (1) there is high-level evidence linking the late effect with the therapeutic exposure, and (2) the screening recommendation is appropriate based on the collective clinical experience of panel members.2AThere is uniform consensus of the panel that (1) there is lower-level evidence linking the late effect with the therapeutic exposure, and (2) the screening recommendation is appropriate based on the collective clinical experience of panel members.2BThere is non-uniform consensus of the panel that (1) there is lower-level evidence linking the late effect with the therapeutic exposure, and (2) the screening recommendation is appropriate based on the collective clinical experience of panel members.3There is major disagreement that the recommendation is appropriate.
Uniform consensus: Near-unanimous agreement of the panel with some possible neutral positions.
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
External Peer Review
Description of Method of Guideline Validation
The initial version of the guidelines (Version 1.0 – Children's Oncology Group Late Effects Screening Guidelines) was released to the Children's Oncology Group (COG) membership in March 2003 for a six-month trial period. This allowed for initial feedback from the COG membership, resulting in additional review and revision of the guidelines by the Late Effects Committee prior to public release.
All revisions proposed by the task forces were evaluated by a panel of experts, and if accepted, assigned a score (see "Rating Scheme for the Strength of the Evidence"). Proposed revisions that were rejected by the expert panel were returned with explanation to the relevant task force chair. If desired, task force chairs were given an opportunity to respond by providing additional justification and resubmitting the rejected task force recommendation(s) for further consideration by the expert panel.