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新規開発や新技術の検証、導入にまつわる記事を投稿しよう！
@kaizen_nagoya(Dr. Kiyoshi Ogawa)

メラノーマガイドラインパブリックコメントにIT関係者からの意見を出す準備

Last updated at Posted at 2019-05-08

医療系の現状と課題
https://qiita.com/kaizen_nagoya/items/5734255c49b6eca4565d

で引用している

メラノーマガイドラインパブリックコメントの募集について
http://www.skincancer.jp/info_melanoma190415.html

について、IT関係者からの意見をどのようにまとめるかの事例を記録する。

医療システムは、主に次の３つを想定している。

計算機を内蔵している機器
解析に計算機を利用している
記録・管理に計算機を利用している

これらのソフトウェアは、従来は全く異なるOSで管理し、全く異なる通信網(network)に接続されてきた。

最近では内蔵機器のOSがLinuxだった、通信にWi-Fi, bluetoothを使っていたり、ほぼ継ぎ目なく(seamless)につなぐくとができる場合がある。

そこで、医療技術だけでなく、OS、通信、データ解析技術を統合的に設計、運用することになる。

メラノーマガイドライン序文（PDFファイル 2.30 MB）
http://www.skincancer.jp/info_melanoma_j190415.pdf
からの引用はページ数のみ

CQ統合版（PDFファイル 478 KB）
http://www.skincancer.jp/info_melanoma190415.pdf
からの引用はページ数の前にCQをつける。

#確認事項
ここまでの作業で確認できたこと

  1. 用語
    専門用語以外はカタカナ語を少なくし、専門性のない概念の文字数を減らし、専門性のある内容に注力できるようにするとよい

専門用語は用語集として略号、資料URLなどをつける。
英語、日本語の対比もあるとよい。

日本語と英語の違いでの見落としの確率が減る。

  1. 参考文献
    参考文献のうち、本文がWEBにあるものはURLを必ずつける。抄録しかない場合でも、URLをつける。
    最適なURLであるかどうかは、未確認であると断る。

#用語

医療専門用語がカタカナ語である場合には、専門的な考察が必要であるため意見は留保する。
しかし、医療専門用語以外のカタカナ語を多用すると、医療専門用語との区分があいまいになり、
用語定義しないで利用していると医療専門用語として使っているのかどうかが不明確になる。

CQ

p.6

その是非について十分なコンセンサスが確立していると考えられる事項（background question）については，本ガイドラインの前半部分 に新たに総論を設けてそのなかで紹介することとした．Background Question とするには議論の余地が残る重要臨床事項について，これまでと同様に臨床質問を作成し（foreground question），クリニカルクエスチョン（clinical question: CQ）として後半に記述した．

CQは、頻出単語でここでfull spellも、意味の説明もあり、略号として使うのにふさわしい。

background question, foreground questionも、BQ, FQとして用いるとよいかどうかは全文での頻度による。

#言い換え案
日本語案が空欄の用語は、よい言葉がおもいあたっていないもの。
思い当たる言葉がありましたら、コメント欄などでご教示ください。
またより適切な日本語案についても同様です。

カタカナ語 日本語案 英語
ガイドライン 指針 guideline
スクリーニング 予備選別 screening
チーム 班 team
グループ 班 group
パネリスト panelist
システマティク 体系的 systematic
レビュー 見直し review
エビデンス 証拠 evidence
マニュアル 手引き manual
コンセンサス 合意 consensus
ハンドリサーチ 人手検索 hand search
テンプレート 雛形 template
アウトカム 成果 outcome
デザイン 設計 design
バイアス 偏向 bias
リスク 危険性 risk
メタアナリシス meta analysis
センター 本部, 施設 center
レポート 報告 report
バランス 均衡 balance
コスト 費用 cost
シート 表 sheet
チーフ 主任、筆頭 cheaf
メール 郵便 mail
パブリックコメント 意見公募 public comment
ロードマップ 計画図 road map
フォーマット 書式 format
テーマ 主題 thema
コメント 意見 comment
モニタリング 監視 monitoring
アンケート 質問票 questionnaire
ホームページ home page
ガイダンス 指導 guidance
チェックポイント 検査点 check point
カテゴリー 分類 category
サブグループ 分班 sub group
ストレス 圧迫 stress
ルール 規則 rule

meta analysis

Primary, secondary and meta-analysis of research. Educational Researcher 10: 3-8.
, Gene V Glass, 1976
http://www.jameslindlibrary.org/glass-gv-1976/

専門用語資料

カタカナ語 日本語 英語 略号 URL
メラノーマ
ダーモスコピー
センチネルリンパ
クリニカルクエスチョン clinical question CQ
backgroud question
foregroud question
Patients, problem population, Interventions, Comparions, controles, comparators, Outcomes PICO
Conchrance Library
PubMed
- 医学中央雑誌
- 経済的利益相反 Conflict of Interest COI
疫学
メラノサイト
腫瘍
臨床症状
病理所見
表在拡大型
末端黒子型
悪性黒子型
結節型
皮膚
粘膜
眼球脈絡膜
脳軟膜
遺伝子変異
紫外線暴露量
色素性病変
罹患率
WHO
GLOBOCAN
リンパ
BRAF
MAPキナーゼ
P13キナーゼ
NRAS
解剖学的部位
日光暴露累積量 cumulative sun damage CSD
四肢末端部 acral
粘膜部 mucosal
眼球内 uveal
malignant Spitz tumor
先天性色素性母斑
青色母斑
水平方向進展 radial growth phase
垂直方向進展 vertical growth phase
VRAF V600E
KIT
チロシンキナーゼ
膜受容体型
阻害薬
cyclin dependent kinase 4/cylinD1 CDK4/CCND1
GNAQ/GNA11
mammalian target of rapamycin) mTOR
cyclin-dependant kinase inhibitor 2A CDKN2A
PTEN
telomerase reverse transcriptase)， TERT
neurofibromin-1 NF-1
American Joint Committee on Cancer AJCC
Union for International Cancer Control UICC
臨床分類 cTNM
生検
原発巣
部分生検
全切除生検
センチネルリンパ節生検
病理学的分類 pTNM
in-transig
乳酸脱水酵素 LDH
腫瘍厚さ tumor thickness： TT
ocular micrometer
原発腫瘍評価不可能 pTX
フィブリン沈着
メラノーマin situ ．Tis
Asymmetry，Border irregularity，Color variegation，Diameter>6mm，Evolution ABCDE

#手順

p.9

ii. 投票を行う CQ に関連して，規定を超える経済的利益相反（COI）または学術的 COI，その他のCOIを有する委員は，議論に参加可能だが投票を棄権する．

経済的利益相反は投票を棄権するのは合理的。
学術的、その他が棄権する根拠は、「規定による」。

学術的COIがないような専門家はいないはずである。単に専門家を排除する印象がある。

p.13

1）利益相反の申告
2017年3月に日本医学会より公表された「診療ガイドライン策定参加資格基準ガイダンス」（以下，参加基準ガイダンス）5)に従い，ガイドライン改訂委員会委員，外部評価委員が就任時に前年にさかのぼって過去3年間分とガイドライン公表までの1年ごとの利益相反（conflict of interest: COI）の開示を行った．申告に際しては，1）委員本人のCOI，委員の配偶者，2）1親等親族または収入・財産的利益を共有する者のCOI，3）委員が所属する組織・部門にかかる組織COIを，参加基準ガイダンスの定めるCOI自己申告書にて金額区分（図1A, 1B） とともに申告した．

診療ガイドライン策定参加資格基準 ガイダンス - 日本医学会
https://www.google.co.jp/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=2ahUKEwiy7MSU64riAhXMPXAKHeUEDHEQFjAAegQIAxAC&url=http%3A%2F%2Fjams.med.or.jp%2Fguideline%2Fclinical_guidance.pdf&usg=AOvVaw08ro92lHZrZgh861u6jF5U

規定の妥当性を別途確認中。

#遺伝子

遺伝子に関する資料は、従来の疫学、病理学などと連続している。
情報源および情報量の多寡の記載があるとよい。
また遺伝子に関する資料は急増しており、従来の医学論文の分析の方法によらない方法も模索するとよい。
また、経済的CIO、学術的CIOを検討するには、学術的なフィルタによらない情報源の収集が大事である。

BRAF

肺癌患者における BRAF 遺伝子変異検査の手引き
https://www.haigan.gr.jp/uploads/files/photos/1620.pdf

メラノーマにおけるBRAF V600変異の検出 宇 原 久
0238 モダンメディア 61 巻 8 号 2015[臨床検査アップデート]
http://www.eiken.co.jp/modern_media/backnumber/pdf/MM1508_04.pdf

アレイ バイオファーマ社、BRAF 遺伝子変異陽性の転移性大腸がんを対象とした BRAFTOVI®、MEKTOVI®および ERBITUX®の併用療法の第III相 BEACON CRC 試験の 安全性導入期(Safety Lead-in)結果において全生存期間の中央値 15.3 カ月を発表
https://www.ono.co.jp/jpnw/PDF/n19_0115_2.pdf

京都がん研究会メールマガジン第 166 号 (2018 年2月)
BRAF 変異陽性肺癌の最近の話題
(文責 京都大学医学部附属病院 呼吸器内科 阪森優一)
http://ganpro.med.kyoto-u.ac.jp/wp-content/uploads/2018/02/mm166_201802.pdf

BRAF遺伝子検査 ※詳細は次ページをご覧ください。 (オンコマインTM Dx TargetTest CDx システム)5,000点

平成 27 年度 学内グラント終了時報告書 日本人悪性黒色腫における体細胞遺伝子変異ならびに
バイオマーカー候補と臨床料理学的因子との関連に関する研究 寺本由紀子(国際医療センター 皮膚腫瘍科)埼玉医科大学雑誌 第 43 巻 第 1 号 平成 28 年 8 月
http://www.saitama-med.ac.jp/jsms/vol43/01/jsms43_043_047.pdf

保険適用、料金の変化

臨床検査の保険適用について(平成30年8月収載予定) BRAF 遺伝子検査
https://www.mhlw.go.jp/content/12404000/000334420.pdf

検査実施料新設のお知らせ　No.2018-58 平成 30 年 12 月　株式会社エスアールエル
https://www.srl-group.co.jp/assets/pdf/news/testing/2018-58.pdf

BRAF遺伝子検査 (オンコマインTM Dx TargetTest CDx システム) 5,000点

新規受託開始のお知らせ　項目コード:2663 No.2018-19 RAS-BRAF遺伝子変異解析 受託開始日:2018年9月8日(土)受付分より
http://www.sms.co.jp/reference/info/2018_19.pdf?PHPSESSID=581ff6a343dd7fdba8f0c20ca88fe40c

4,000点(包括点数)※4※5 (悪性腫瘍組織検査 「1」悪性腫瘍遺伝子検査) (保険請求上は、「RAS遺伝子検査」および「BRAF遺伝子検査」の2項目扱いとなります。

#調査資料
直接資料に掲載されているかどうかは未確認であるが、調査の途中で有用と推定した資料の記録。
参考文献に掲載のある事項は順次連携もしくは移動予定

この皮膚悪性腫瘍診療ガイドラインについて
https://www.dermatol.or.jp/medical/guideline/skincancer/about.html

参照資料

参考文献と二次資料

Evidence-based Dermatology. Williams W, et al (eds), BMJ Books, London, 2003
The Cochrane Library：http://www.thecochranelibrary.org
BMJ Clinical Evidence：http://www.clinicalevidence.org
UpToDate：http://www.uptodate.com
欧米の主要ガイドライン

The National Comprehensive Cancer Network（NCCN）：http://www.nccn.org
National Cancer Institute Physician Data Query：http://www.cancer.gov/cancer_information/pdq/
オーストラリア政府のガイドライン：http://www.nhmrc.gov.au/publications/subjects/cancer.htm
Scottish Intercollegiate Guidelines Network （SIGN）：http://www.sign.ac.uk/

文献

GLOBOCAN: Cancer Incidence. Mortality and Prevalence Worldwide, World Health Organization, Lyon, 2001

2004年に改定あり。ResearchgateでRequest now.

参考文献

先頭100文献中URLの記載は４

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