JP5694948B2 - 慢性病患者の診断支援または治療支援のための構造化検査方法及びその装置 - Google Patents
慢性病患者の診断支援または治療支援のための構造化検査方法及びその装置 Download PDFInfo
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Description
本発明は、様々な実施形態に関連して、以下に説明されるだろう。当業者は、本発明が多数の異なる応用及び実施形態で実施されてもよく、その応用でここに示される特定の実施形態に特に限定されないことを理解するだろう。特に、本発明は、採血を介する糖尿病管理に関連して、後述されるだろう。しかし、当業者は、本発明がブドウ糖以外の、他の型の液体または検体と共に使用される、及び/または、糖尿病以外の、他の慢性病を管理することに役立つように修正され得ることを認識するだろう。
図5Aは、医学的使用事例または医学的質問のために、図5Bにより示される構造化収集手続70を作成する方法200を示す。構造化収集手続70は、スタンドアロンソフトウェア、糖尿病ソフトウェア34の一部、または紙ツール38の一部として、上記の装置18、24、25、26、28、36、52のいずれか1つに実装されてもよい。ステップ202では、医学的使用事例または医学的質問(以下、一般に使用事例として参照される)が選択される及び/または定義され得る。使用事例は、例えば、次の医学的使用事例または医学的質問から選択されるものであってもよいことを理解すべきである。特定の食物を摂取する効果を知りたい、食前及び/または食後に薬を服用する最善の時間を知りたい、及び運動のbG値への効果を知りたい。他の使用事例は、診断結果を見付けること、患者への治療を初期化する最善の方法、患者の病気の進行の状態の決定を行うこと、患者の治療を最適化する最善の方法を見付けること等に関する質問であってもよい。さらに他の例は、空腹時血糖、食前糖値、食後糖値等に関する医学的質問に対処するのに役立つように使用され得る構造化収集手続70を提供することであり得る。他の医学的質問は、所定の文脈で生体指標を管理すること、所定の文脈で生体指標を最適化すること、治療開始、治療の型、経口単剤治療、経口組み合わせ治療、インスリン治療、生活スタイル治療、治療の順守、治療効果、インスリンの注射または吸入、インスリンの型、基礎及びボーラスでのインスリンの分割等に関連することであり得る。例えば、経口単剤治療及び経口組み合わせに関する医学的質問は、スルホニル尿素、ビグアニド、チアゾリジンジオン、α−グルコシダーゼ阻害剤、メグリチニド、ジペプチジルペプチダーゼIV阻害剤、GLP−1アナログ、タスポグルタイド、PPARデュアルα/γアゴニスト、アレグリタザルに関するものを含み得る。選択された使用事例は、図5Bに示される医学的使用事例パラメータ220に割り当てられ得る。
図6A〜6Eは、構造化収集手続70a、70b、70c、及び70dの例を示し、関連技術の当業者により上記の装置18、24〜26、28、36、52のいずれか1つに実行されてもよい命令コードに容易に変換され得る機能を示す。それゆえに、簡潔のために、示される機能に関連する擬似コードまたは実コードに関して、説明は与えられない。
例えば、いくつかの疫学研究は、食後糖(PPG)値の上昇が、心血管死亡及び2型糖尿病(T2D)での死亡の有意な予測因子であることを確認した。このため、高食後bG値を示すT2Dに処方され得る、週1回長時間作用型グルカゴン様ペプチド−1(GLP1)薬群がある。これらのGLP1薬は、インスリン分泌を促進し、グルカゴン分泌を抑制することにより、血糖調節に重要な役割を果たす天然ホルモンGLP−1と同様である。それゆえに、構造化収集手続70が、一実施形態で提供され得る。構造化収集手続70は、1回以上の食事の後でのbG値の集中的な測定により、測定食後bG値の低減を使用して治療効果が示されるのを可能にすることを提案する。その測定値に基づき、GLP1薬の推奨投与量及び/または特定のGLP1薬が患者に対して適切な薬かどうかが決定され得る。
図7Aは、慢性病患者の診断支援または治療支援のための構造化検査方法300を示す。方法300は、プロセッサ及びメモリを備えるコンピュータで実行されるプログラムの命令コードとして、例えば好ましくは臨床医コンピュータ25(図2)のスタンドアロンソフトウェア、ソフトウェア34の一部、または公衆網50を介して安全なウェブ実装によりサーバ52によりサービスとして提供されるソフトウェアとして実装されてもよい。プロセッサ76が、臨床医コンピュータ25のメモリ78からプログラムを複数あるうちの一機能として実行するとき、プロセッサ76は、医学的使用事例及び/または医学的質問への問い合わせを受信した後、ステップ302で提出された問い合わせに一致する全構造化収集手続70a〜dを求めて、メモリ78、コンピュータ読み取り可能媒体40、及び/またはサーバ52を検索する。例えば、プロセッサ76は、各利用可能な構造化収集手続70a〜dの医学的使用事例パラメータ220を読み取り、従来の検索アルゴリズム(例えば、リスト、ツリー、ヒューリスティクス等)を使用して、一実施形態では、ステップ304で問い合わせに一致する構造化収集手続の選択肢をディスプレイ82に提供してもよい。
図7Bは、所定の構造化収集手続70の一例を概念的に示す。構造化収集手続70は、その手続が患者の血糖(bG)値の傾向及び/または血糖値と時刻、食事量、エネルギー値との間の関係を知る必要がある医学的使用事例または医学的質問に役立つことを示す規定の医学的使用事例パラメータ220を有する。上記のように、使用事例パラメータ220は、識別タグとして使用され得る。プロセッサ102は、例えば入力された使用事例または質問の検索問い合わせに応じて、関連構造化収集手続70を検索してもよい。例えば、検索問い合わせは、ユーザインターフェース146を介して収集装置24に入力及び/または臨床医コンピュータ25から受信され得る。検索問い合わせは、どの使用事例が収集装置24で現在利用可能な構造化収集手続70により対処され得るか知りたい、またはどの構造化収集手続70が特定の使用事例または質問に対処するのに役立つか知りたいという欲求から生じてもよい。それゆえに、使用事例パラメータ220は、一実施形態では、構造化収集手続70が、例えばメモリ110、メモリ78、コンピュータ読み取り可能媒体40、及び/またはサーバ52に提供される複数の構造化収集手続70a〜dから、例えばプロセッサ102により提供され、ディスプレイ108に表示されるリストから、または規定の医学的質問のユーザインターフェースからプロセッサ102により受信される入力からの選択に基づき、プロセッサ102により自動的に選択されるのを可能にする。他の実施形態において、使用事例パラメータ220はまた、構造化収集手続70がまたbG値と時刻、食事量、エネルギー値との間の関係を示すのに役立つことを示してもよい。
図8Aは、本発明の実施形態に従って患者12から文脈説明生体指標データを得るために、構造化収集手続70を実装及び実行するための方法のフローチャートを示す。ステップ312で指示され、ステップ314(図7A)で実装された多数の構造化収集手続70a〜d(図2)は、装置24のメモリ110(図3)に格納され、任意の希望する時間での実行のために選択されてもよいことを理解すべきである。例えば、ボタン147、149の所定の組み合わせを押下すると、患者は、希望する構造化収集手続70a〜c及び構造化検査手続を開始する日付、即ち設定モード機能を選択できる。例えば、選択される日付範囲は、検査を明日開始し、今日から90日後に終了するものであってもよい。日付範囲は、プロセッサ102がデータファイル145(図4)にセットアップデータ163の一部として記録できる。その実行において、プロセッサ102は、ソフトウェア34により指示されるように、選択された構造化収集手続70のためのセットアップデータ163を読み込み、ディスプレイ108に、装置24が、例えば選択されて注目されている検査の開始日の前日から構造化収集手続の終了まで構造化検査モードにあることを示す。
図8Bは、収集装置24で提供されるグラフィカルユーザインターフェースを介して構造化収集手続を実行する方法を示す。グラフィカルユーザインターフェースは、収集装置で実行されると、プロセッサ102に次のステップを実行させる。ボタン147、149の所定の組み合わせを押下すると、患者12は、ステップ330でプロセッサ102により収集装置24のディスプレイ108に提供されるリスト329内の、選択のために利用可能な構造化収集手続70までスクロールできる。構造化収集手続を開始したければ、患者12は、例えばステップ332でOKボタン151を押下することを介して希望する構造化収集手続70を選択する。この例において、構造化収集手続70の進入基準226(図6)は、プロセッサ102がディスプレイ108上でユーザに表示する情報を、ステップ334で提供する。表示された情報を読み取った後に、ユーザは、ステップ336で任意のボタンを押下する。進入基準226での次の手続が、プロセッサ102により実行される。この示される例において、進入基準226の一部として、質問がステップ338でプロセッサ102により問い合わせられる。患者12が依然、構造化収集手続を開始したければ、患者12は、ステップ340でOKボタン151を選択する。さもなければ、ボタン147、149を介する他の押下は、プロセッサに、リスト329に戻って構造化収集手続70のためのセットアップ手続を終了させる。
図9は、本発明の実施形態に従って糖尿病の診断支援及び治療支援のために生体指標データを文脈説明する方法388を示す。図8A及び8Bを参照して上述された以前の実施形態において、文脈情報156は、構造化収集手続70の間に自動的にプロセッサにより要求され、関連生体指標値と共に記録されたことを理解すべきである。しかし、自動化が収集装置24で提供されない実施形態において、患者は、紙ツール38を使用し、収集データは、例えば構造化収集手続70が少なくともデータ事象値256を作成するためにステップ390で実行された後に、文脈情報156と関連付けられ得る。収集装置24によりまだ終了しなければ、例えば限られたメモリ及び処理能力を備える装置の場合に、または記録が紙ツール38で行われるときに、データは、ソフトウェア34を実行し、少なくともデータ事象値256(図4)をそれぞれのデータ事象要求240と関連付ける機能を有する装置18、25、36の別の1つに提供されてもよい。少なくともデータ事象値256のそれぞれのデータ事象要求240、日時印169、及び文脈情報156とのこの関連付けは、ステップ392で文脈説明(自己監視)データ170をもたらす。
図12は、(例えば、図9のステップ398で)パラメータを調整するための別の方法420のフローチャートを示す。より具体的には、関心文脈説明生体指標値422を指針ベースターゲット範囲に入れることが示される。方法420は、好ましくは、臨床医コンピュータ25で、ソフトウェア34の分析機能として、例えば完了した構造化収集手続70から収集された患者データファイル145に含まれる患者データを評価するために促進される。関心文脈説明生体指標値422は、公知の指針及び標準により提供されるターゲット範囲外に入る。構造化収集手続70の多くにおいて、臨床医により調整のために利用可能な多数のパラメータが存在し得る。それゆえに、臨床医コンピュータ25で実行される体系的手法は、関心生体指標値422を希望するターゲット範囲に入れるために取られる時間及び努力を向上させるのに役立つはずである。図2も参照して、方法420は、ステップ424でディスプレイ82で関心文脈説明生体指標値422を選択することを有する。プロセッサ76は、ステップ424で、選択されるパラメータのリストを表示するだろう。任意のパラメータが選択され得るが、この例では、臨床医により選択されるパラメータは、選択された関心文脈説明生体指標値422をターゲット範囲外からターゲット範囲内に潜在的に移動すると思われるパラメータである。パラメータの例は、ソフトウェア34により専用にされるプロセッサにより提供される薬、投与量、運動の頻度及び時間、並びに食事の頻度、時期、量、及び型の1つ以上を含んでもよい。パラメータの他の例は、メトホルミン投与量、インスリン対糖質比、基礎インスリン投与量、運動、及び食事の1つ以上を含み得る。パラメータのさらに他の例は、タスポグルタイド、アレグリタザル、スルホニル尿素、ビフアニド(bifuanides)、ビグアニド、チアゾリジンジオン、α−グルコシダーゼ阻害剤、メグリチニド、ジペプチジルペプチダーゼIV阻害剤、GLP−1アナログ、PPARデュアルα/γアゴニストの1つ以上を含み得る。
生体指標測定でのノイズの効果をより理解するために、図14は、全ノイズの成分の関係の図を示す。示されるように、全ノイズ450は、システムノイズ452、手続ノイズ454、及び測定方法ノイズ456を含む。全ノイズ450は、測定ノイズ、手続ノイズ、及びシステムノイズを関連付ける関数であり、次の方程式により説明され得る。
全ノイズ=f(測定、手続、システム)
ここで、測定ノイズ、手続ノイズ、及びシステムノイズは、関数の成分である。図14において、横軸は時間458を示し、縦軸は生体指標値460を示す。縦軸はさらに、生体指標設定値462、上限値464、及び下限値466を示す。システムノイズ452、手続ノイズ454、測定ノイズ456、及びそれらの組み合わせのために調整された新たなノイズ特徴付け生体指標値468が示される。
本発明の実施形態により提供される上記の利点を示すのに役立つように、次の使用事例の例が与えられる。糖尿病の診断支援及び治療支援のための生体指標データの文脈説明が、関心生体指標、即ちブドウ糖を使用し、構造化収集手続を参照して後述されるが、様々な他の実施形態が、例えばトリグリセリド、コレステロール、低密度脂質、高密度脂質等の、構造化収集手続を作成し(図5A、5B、7A、及び7B)、構造化収集手続を実行し(図8A及び8B)、パラメータを調整し(図9及び12)、及びノイズモデル化関数を作成する(図15)要素からの他の生体指標に対して構成され得る。
Claims (16)
- 慢性病患者(12)の診断支援または治療支援のための収集装置(24)であって、
ディスプレイ(108)と、
ユーザインターフェース(146)と、
前記ディスプレイ(108)及び前記ユーザインターフェース(146)に連結されたプロセッサ(102)と、
前記プロセッサ(102)により実行されると、前記プロセッサ(102)に、
前記ディスプレイ(108)で選択のために慢性病に関連する複数の医学的使用事例を促し、
前記ユーザインターフェース(146)を介して選択された医学的使用事例を受信し、
前記選択された医学的使用事例に基づいてメモリ(110)に格納された複数の構造化収集手続(70)から前記慢性病患者(12)の前記診断支援または治療支援のための構造化収集手続(70)を自動的に選択し、
前記選択された構造化収集手続(70)を実行させ、
前記構造化収集手続(70)は、事象の工程(222)を定義するパラメータ(220、222、224、226、228、230、232、237、238、240)を有し、前記事象(237)の各々は、少なくとも1つの型の生体指標データの収集の要求(240)を含む、プログラム(34)命令と、を備え、
前記選択された構造化収集手続(70)は、
前記医学的使用事例に基づいて生体指標データを収集する前に満たされる必要がある条件を規定する進入基準(226)が満たされると、前記選択された構造化収集手続(70)の事象(237)の各々を自動的に開始し、
前記選択された構造化収集手続(70)の事象(237)の各々が実行されて収集した生体指標データを前記メモリ(110)に格納し、
前記の実行された事象(237)が前記医学的使用事例に対処するのに受け入れ可能なデータを提供したかどうかを定性的に評価するために使用される順守基準(224)を満たせば、前記生体指標データに前記メモリ(110)内で一意の識別子を自動的に関連付け、
前記構造化収集手続(70)を終了する前に満たされる必要がある条件を規定する退出基準(228)が満たされると、自動的に終了する収集装置。 - 前記構造化収集手続(70)の前記パラメータ(220、222、224、226、228、230、232、237、238、240)は、プロセッサ(102)が事象の工程(222)を実行するために満たされる必要がある1つ以上の条件を規定する、少なくとも1つの進入基準(226)をさらに定義する、請求項1に記載の診断支援または治療支援のための収集装置(24)。
- 前記進入基準(226)は、前記構造化収集手続(70)が自動的に選択され、前記進入基準(226)を満たすと前記事象の工程(222)が開始されるように、特定の医学的質問として定義される、請求項2に記載の診断支援または治療支援のための収集装置(24)。
- 前記構造化収集手続(70)の前記パラメータ(220、222、224、226、228、230、232、237、238、240)は、前記事象の工程(222)に従って実行された事象(237)が前記選択された医学的使用事例に対処するのに受け入れ可能なデータ(256、170、145)を提供したかどうかを定性的に評価するために使用される1つ以上の条件を規定する、少なくとも1つの順守基準(224)をさらに定義する、請求項1に記載の診断支援または治療支援のための収集装置(24)。
- 前記順守基準(224)は評価され、前記評価に基づいて前記構造化収集手続(70)は動的に適合する、請求項4に記載の診断支援または治療支援のための収集装置(24)。
- 前記構造化収集手続(70)の前記パラメータ(220、222、224、226、228、230、232、237、238、240)は、前記構造化収集手続(70)を終了する前に満たされる必要がある1つ以上の条件を規定する、少なくとも1つの退出基準(228)をさらに定義する、請求項1に記載の診断支援または治療支援のための収集装置(24)。
- 前記プロセッサ(102)は、出力として前記選択された構造化収集手続(70)を実行する、請求項1に記載の診断支援または治療支援のための収集装置(24)。
- 前記収集装置(24)は、臨床医コンピュータ(25)及び携帯収集装置(26、28、36、48)の1つである、請求項1に記載の診断支援または治療支援のための収集装置(24)。
- 前記選択された構造化収集手続(70)の前記出力は、携帯血糖メータ(26)に提供される、請求項7に記載の診断支援または治療支援のための収集装置(24)。
- 前記出力は、印刷紙ツール(38)、収集装置(24)により操作されるソフトウェア(34)、収集装置(24)に送信されるソフトウェア(34)、収集装置(24)、臨床医コンピュータ(25)のディスプレイ(82)、及び携帯収集装置(24)のディスプレイ(108)によりサーバ(52)からダウンロードされるソフトウェア(34)の1つである、請求項7に記載の診断支援または治療支援のための収集装置(24)。
- 前記メモリ(110)は、前記収集装置(24)に提供される、前記収集装置(24)に備わる、及び前記収集装置(24)により遠隔からアクセスされる、の1つである、請求項1に記載の診断支援または治療支援のための収集装置(24)。
- 前記複数の医学的使用事例は、インスリン対糖質比を最適化すること、食事開始に対するボーラス投与時期を決定すること、及び運動相当を決定することを含む、請求項1に記載の診断支援または治療支援のための収集装置(24)。
- 前記複数の医学的使用事例は、所定の文脈で生体指標を管理すること、治療開始、治療の型、経口単剤治療、経口組み合わせ治療、インスリン治療、生活スタイル治療、治療の順守、及び治療効果に関する1つ以上の質問を含む、請求項1に記載の診断支援または治療支援のための収集装置(24)。
- 前記経口単剤治療は、スルホニル尿素、ビグアニド、チアゾリジンジオン、α−グルコシダーゼ阻害剤、メグリチニド、ジペプチジルペプチダーゼIV阻害剤、GLP−1アナログ、タスポグルタイド、PPARデュアルα/γアゴニスト、及びアレグリタザルからなる群から選択される、請求項13に記載の診断支援または治療支援のための収集装置(24)。
- 前記経口組み合わせ治療は、スルホニル尿素、ビグアニド、チアゾリジンジオン、GLP−1アナログ、タスポグルタイド、PPARデュアルα/γアゴニスト、及びアレグリタザルからなる群から選択される1つ以上である、請求項13に記載の診断支援または治療支援のための収集装置(24)。
- 前記インスリン治療は、インスリンの注射または吸入、インスリンの型、及び基礎及びボーラスでのインスリンの分割からなる群から選択される1つ以上である、請求項13に記載の診断支援または治療支援のための収集装置(24)。
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