小児神経外科領域の希少疾患に対する診療ガイドライン 作成への助言：小児脳腫瘍での作成経験から.

Clinical guidelines are developed based on evidence from a comprehensive collection of clinical studies on a target disease while eliminating various biases. In Japan, the Medical Information Sharing Organization (Minds) provides standardized procedures for creating clinical guidelines, and Minds’ clinical guideline creation manuals are intended mainly for relatively common diseases for which clinical results are obtained from multiple randomized clinical trials. However, the manual does not include much on rare diseases. In 2022, clinical guidelines for six major kinds of pediatric brain tumors were published. The development of these guidelines dates back to 2013, when there were no guidelines for pediatric brain tumors, despite the fact that they have the highest incidence among pediatric solid malignant tumors. Under such circumstances, the Japanese Society for Pediatric Neurosurgery proposed the development of clinical guidelines to the Japanese Society of Neuro-Oncology, and the clinical guidelines were finally completed by following the Minds manual, while overcoming difficulties due to the rarity of these tumors. Currently, it is hoped that guidelines will be developed for other pediatric neurosurgical diseases as well, such as developmental abnormalities of the central nervous system. However, since these diseases are relatively rare, they are likely to face the same difficulties as pediatric brain tumors. Based on our experience in developing these guidelines, this paper presents some tips that may be useful for the efficient development of clinical guidelines for other rare pediatric neurosurgical diseases. According to the Minds manual, the first step is to establish a steering committee, a guideline development group, and a systematic review team. The steering committee has full responsibility for decision-making in guideline development. Each guideline development group, consisting of members with extensive experience in the target disease, conducts a scoping search to determine the scope, which is comprised of several key clinical issues related to the target disease and corresponding clinical questions (CQs), etc. For each CQ, certain conditions are proposed for selecting clinical articles for systematic review. In our experience, as a preliminary search, scoping searches are extremely important for appropriate systematic reviews in the development of new clinical guidelines. The systematic review team comprehensively collects articles for systematic review of each CQ and selects under the conditions guided by the scoping search. For rare diseases where most selected articles on treatment or prevention are not commonly based on randomized clinical trials, a qualitative systematic review will be conducted to estimate the Body of Evidence. Although the level of evidence derived from a qualitative systematic review is not as high as that from a quantitative one, the strength of recommendations for each CQ based on Body of Evidence should be discussed and determined at meetings where all members of each guideline development group are requested to share their experiences. We believe that these tips will enable the efficient development of clinical guidelines in accordance with the Minds manual, even for relatively rare pediatric neurosurgical diseases. [ABSTRACT FROM AUTHOR]