Article type
Abstract
Background
With the exponentially growing medical literature, the process of updating guidelines is now more important than ever. Numerous papers providing guidance on when and how to update have been published, nevertheless, these guidance papers mostly utilize fields with abundant evidence for their frameworks. Limited information on the value of updating guidelines in fields with scarce evidence has been published.
Objectives
This study aims to describe the changes in evidence and recommendations when updating the 2018 ASH management guidelines for pediatric venous thromboembolism (VTE). Additionally, we aim to describe unique considerations when updating guidelines of “rare” disease entity with scarce published literature.
Methods
We compared the evidence which informed each outcome between the original 2018 guidelines and the current update. We summarized study type, number of patients and events, and overall certainty of evidence (CoE), that informed 16 updated recommendations. We also describe the changes in strength and direction of recommendations.
Results
From the 16 recommendations, two changed in strength, one changed in direction, and one changed in CoE. Details on the changes in recommendations are described in Table 1. Despite only 4 recommendations changing, 45 outcomes out of 101 (44.5%) relied on higher quality/certainty evidence. Thirty-two (31.6%) outcomes in 8 recommendations that relied on non-comparative data in the original guideline relied on comparative data in the update. Four (3.9%) outcomes in three recommendations with no data in the original guidelines now relied on comparative. Five (4.9%) outcomes in two recommendations that relied on adult comparative data in the original guidelines now relied on pediatric comparative. Lastly, four (3.9%) outcomes in one recommendation changed from non-comparative to randomized control trials. Table 2 describes the changes in outcomes. On average, each recommendation relied on 2.1 additional comparative studies with a mean of 94.5 additional patients.
Conclusions
Despite the limited published literature in the field of pediatric VTE, substantial changes in the evidence informing the updated recommendation were utilized. The panel considered this critical as to ensure the field and guidelines are informed by the most updated and best available evidence even if it does not lead to a change in recommendation.
With the exponentially growing medical literature, the process of updating guidelines is now more important than ever. Numerous papers providing guidance on when and how to update have been published, nevertheless, these guidance papers mostly utilize fields with abundant evidence for their frameworks. Limited information on the value of updating guidelines in fields with scarce evidence has been published.
Objectives
This study aims to describe the changes in evidence and recommendations when updating the 2018 ASH management guidelines for pediatric venous thromboembolism (VTE). Additionally, we aim to describe unique considerations when updating guidelines of “rare” disease entity with scarce published literature.
Methods
We compared the evidence which informed each outcome between the original 2018 guidelines and the current update. We summarized study type, number of patients and events, and overall certainty of evidence (CoE), that informed 16 updated recommendations. We also describe the changes in strength and direction of recommendations.
Results
From the 16 recommendations, two changed in strength, one changed in direction, and one changed in CoE. Details on the changes in recommendations are described in Table 1. Despite only 4 recommendations changing, 45 outcomes out of 101 (44.5%) relied on higher quality/certainty evidence. Thirty-two (31.6%) outcomes in 8 recommendations that relied on non-comparative data in the original guideline relied on comparative data in the update. Four (3.9%) outcomes in three recommendations with no data in the original guidelines now relied on comparative. Five (4.9%) outcomes in two recommendations that relied on adult comparative data in the original guidelines now relied on pediatric comparative. Lastly, four (3.9%) outcomes in one recommendation changed from non-comparative to randomized control trials. Table 2 describes the changes in outcomes. On average, each recommendation relied on 2.1 additional comparative studies with a mean of 94.5 additional patients.
Conclusions
Despite the limited published literature in the field of pediatric VTE, substantial changes in the evidence informing the updated recommendation were utilized. The panel considered this critical as to ensure the field and guidelines are informed by the most updated and best available evidence even if it does not lead to a change in recommendation.