_益と害の定量的評価法文献まとめ33.htm

	Aim	益と害の定量的評価法。	33/948
	RQ		Benefits-HarmsまたはBenefit-Riskの評価に関する主に最近の論文。（マニュアルサーチの結果を含む。）
	Level	Low
	Time	2018.12.22 20:42
	Query	((((14698953[uid] OR 26456379 [uid] OR 26521865 [uid] OR 26800458 [uid] OR ))) OR (Froberg DG[au] AND Kane RL[au] AND Methodology[tiab] AND health-state preferences[tiab] AND humans[mh] AND (english[la] OR japanese[la]))) OR (((benefit OR benfits) AND (harm OR harms OR risk) AND decision making AND (model OR models) AND (analysis OR analyse OR analyze OR analyzing OR analysing) AND 2010:2019[dp] AND humans[mh] AND (english[la] OR japanese[la])) OR (decision making AND (model OR models) AND (analysis OR analyse OR analyze OR analyzing OR analysing) AND systematic review[TW] AND 2010:2019[dp] AND humans[mh] AND (english[la] OR japanese[la])))
1	Patel KK 2017	Patel KK, Arnold SV, Chan PS, Tang Y, Pokharel Y, Jones PG, Spertus JA: Personalizing the Intensity of Blood Pressure Control: Modeling the Heterogeneity of Risks and Benefits From SPRINT (Systolic Blood Pressure Intervention Trial). Circ Cardiovasc Qual Outcomes 2017;10. PMID: 28373269	Link FT	major adverse cardiovascular events (MACE)、treatment-related serious adverse events (SAE)と死亡をアウトカムとして、SPRINT試験の9361名の参加者のデータを解析。予測モデルを作成。SBP<120mmHgを目標とする場合と<140mmHgにする場合と比べると、MACE,死亡は2.2％減るが、SAEも同程度増加する。予測モデルのC-indexは0.7程度。
2	Zhang Y 2017	Zhang Y, Coello PA, Brożek J, Wiercioch W, Etxeandia-Ikobaltzeta I, Akl EA, Meerpohl JJ, Alhazzani W, Carrasco-Labra A, Morgan RL, Mustafa RA, Riva JJ, Moore A, Yepes-Nuñez JJ, Cuello-Garcia C, AlRayees Z, Manja V, Falavigna M, Neumann I, Brignardello-Petersen R, Santesso N, Rochwerg B, Darzi A, Rojas MX, Adi Y, Bollig C, Waziry R, Schünemann HJ: Using patient values and preferences to inform the importance of health outcomes in practice guideline development following the GRADE approach. Health Qual Life Outcomes 2017;15:52. PMID: 28460638	Link FT	GRADE WGの論文。決定的な内容ではない。Values/Preferences = Unitlitiesの測定方法まではまとめられているが、それらを用いて益と害の大きさとバランス、正味の益を明らかにする方法についてはまとめられていない。
3	Agapova M 2017	Agapova M, Bresnahan BB, Higashi M, Kessler L, Garrison LP, Devine B: A proposed approach for quantitative benefit-risk assessment in diagnostic radiology guideline development: the American College of Radiology Appropriateness Criteria Example. J Eval Clin Pract 2017;23:128-138. PMID: 27762080	Link	米国放射線医学会の検討。Quantitative benefit-risk assessment (QBRA) methodsの中から2つの方法が有用。エキスパートの意見の不一致＋エビデンスがないか弱い場合はMCDA Multi-criteria decision analysisを推奨。エビデンスが弱い＋エキスパートの意見は一致している場合はIncremental net health benefit法またはMCDAとの併用を推奨。
4	Basu S 2017	Basu S, Sussman JB, Rigdon J, Steimle L, Denton BT, Hayward RA: Benefit and harm of intensive blood pressure treatment: Derivation and validation of risk models using data from the SPRINT and ACCORD trials. PLoS Med 2017;14:e1002410. PMID: 29040268	Link FT
5	Bansback N 2016	Bansback N, Harrison M, Marra C: Does Introducing Imprecision around Probabilities for Benefit and Harm Influence the Way People Value Treatments? Med Decis Making 2016;36:490-502. PMID: 26304064	Link	効果推定値の不確実性の定量的提示と定性的提示では患者の判断が変わるか？定性的な提示の方が理解されやすい。
6	Yu T 2016	Yu T, Holbrook JT, Thorne JE, Puhan MA: Using a patient-centered approach to benefit-harm assessment in treatment decision-making: a case study in uveitis. Pharmacoepidemiol Drug Saf 2016;25:363-71. PMID: 26798977	Link FT	ぶどう膜炎益と害の評価の方法により異なる結論になる。Gail/NCI法を用いている。RDとアウトカムの重要度から全体の益・害を計算。益と害のアウトカムの同時生起も考慮。RD＊Outcome importanceの合計による益と害のバランスの判定と、実際の患者さんのQOLの調査結果による判定が異なる場合がある。Joint occurence of benefits and harmsも検討。
7	McCaffrey N 2016	McCaffrey N, Al-Janabi H, Currow D, Hoefman R, Ratcliffe J: Protocol for a systematic review of preference-based instruments for measuring care-related outcomes and their suitability for the palliative care setting. BMJ Open 2016;6:e012181. PMID: 27619829	Link FT	SRのプロトコール：緩和医療領域におけるpreference-based instruments for measuring care-related outcomesに関するシステマティックレビュー。International Society for Quality of Life Researchのチェックリストを使用。
8	Cameron CG 2016	Cameron CG, Synnott PG, Pearson SD, Dubois RW, Ciarametaro M, Ollendorf DA: Evaluating the Importance of Heterogeneity of Treatment Effect: Variation in Patient Utilities Can Influence Choice of the "Optimal" Oral Anticoagulant for Atrial Fibrillation. Value Health 2016;19:661-9. PMID: 27565284	Link FT
9	Thorat MA 2016	Thorat MA: Individualised benefit-harm balance of aspirin as primary prevention measure - a good proof-of-concept, but could have been better…. BMC Med 2016;14:101. PMID: 27383519	Link FT
10	Hughes D 2016	Hughes D, Waddingham E, Mt-Isa S, Goginsky A, Chan E, Downey GF, Hallgreen CE, Hockley KS, Juhaeri J, Lieftucht A, Metcalf MA, Noel RA, Phillips LD, Ashby D, Micaleff A, PROTECT Benefit-Risk Group: Recommendations for benefit-risk assessment methodologies and visual representations. Pharmacoepidemiol Drug Saf 2016;25:251-62. PMID: 26800458	Link FT	☆☆☆Hallgreen CE 2016と連携した内容。
11	Hallgreen CE 2016	Hallgreen CE, Mt-Isa S, Lieftucht A, Phillips LD, Hughes D, Talbot S, Asiimwe A, Downey G, Genov G, Hermann R, Noel R, Peters R, Micaleff A, Tzoulaki I, Ashby D, PROTECT Benefit-Risk group: Literature review of visual representation of the results of benefit-risk assessments of medicinal products. Pharmacoepidemiol Drug Saf 2016;25:238-50. PMID: 26521865	Link FT	☆☆☆Innovative Medicine Initiative Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT)のproject work package 5 beneﬁt–risk integrationandrepresentation(PROTECTBRgroup)のレポート。
12	Puhan MA 2015	Puhan MA, Yu T, Stegeman I, Varadhan R, Singh S, Boyd CM: Benefit-harm analysis and charts for individualized and preference-sensitive prevention: example of low dose aspirin for primary prevention of cardiovascular disease and cancer. BMC Med 2015;13:250. PMID: 26423305	Link FT	個別患者の益と害の評価のためのチャート。アスピリンを心血管系疾患、癌の予防に用いる場合。
13	Pedersen K 2015	Pedersen K, Sørbye SW, Burger EA, Lönnberg S, Kristiansen IS: Using Decision-Analytic Modeling to Isolate Interventions That Are Feasible, Efficient and Optimal: An Application from the Norwegian Cervical Cancer Screening Program. Value Health 2015;18:1088-97. PMID: 26686795	Link FT	子宮頸癌のスクリーニング（ノルウェイ）。決断分析。
14	Puhan MA 2015	Puhan MA, Yu T, Boyd CM, Ter Riet G: Quantitative benefit-harm assessment for setting research priorities: the example of roflumilast for patients with COPD. BMC Med 2015;13:157. PMID: 26137986	Link FT	効果推定値の不確実性が大きくても益と害の判定における各アウトカムの重要性の評価によっては、益と害のバランスは確実になる場合がある。必ずしも追加の大規模RCTが必要とは限らない。かならずしも更なるRCTではない。その不確実性を最も効率的に減少させる研究がアウトカムの重要度に関する研究の場合もある。それを明らかにするには、定量的益と害のアセスメントが有用。
15	Radawski C 2015	Radawski C, Morrato E, Hornbuckle K, Bahri P, Smith M, Juhaeri J, Mol P, Levitan B, Huang HY, Coplan P, Li H, BRACE Special Interest Group: Benefit-Risk Assessment, Communication, and Evaluation (BRACE) throughout the life cycle of therapeutic products: overall perspective and role of the pharmacoepidemiologist. Pharmacoepidemiol Drug Saf 2015;24:1233-40. PMID: 26456379	Link
16	Mt-Isa S 2014	Mt-Isa S, Hallgreen CE, Wang N, Callréus T, Genov G, Hirsch I, Hobbiger SF, Hockley KS, Luciani D, Phillips LD, Quartey G, Sarac SB, Stoeckert I, Tzoulaki I, Micaleff A, Ashby D, IMI-PROTECT benefit-risk participants: Balancing benefit and risk of medicines: a systematic review and classification of available methodologies. Pharmacoepidemiol Drug Saf 2014;23:667-78. PMID: 24821575	Link	Benefit-Risk balance解析の方法：49種類
17	Puhan MA 2013	Puhan MA, Singh S, Weiss CO, Varadhan R, Sharma R, Boyd CM: Evaluation of the Benefits and Harms of Aspirin for Primary Prevention of Cardiovascular Events: A Comparison of Quantitative Approaches. AHRQ Methods for Effective Health Care 2013; (book) PMID: 24404631	Link FT	Gail/NCI法とNNT/NNHアプローチを比較している。アウトカムの重要性を変えると結論が変わる。Boyd CM 2012に続くAHRQの報告書と思われる。
18	Puhan MA 2012	Puhan MA, Singh S, Weiss CO, Varadhan R, Boyd CM: A framework for organizing and selecting quantitative approaches for benefit-harm assessment. BMC Med Res Methodol 2012;12:173. PMID: 23163976	Link FT
19	Boyd CM 2012	Boyd CM, Singh S, Varadhan R, Weiss CO, Sharma R, Bass EB, Puhan MA: Methods for Benefit and Harm Assessment in Systematic Reviews. AHRQ Methods for Effective Health Care 2012; (book) PMID: 23326898	Link FT	16種類の定量的益と害の評価法がある。2018年の時点でも一番包括的な報告。
20	Guo JJ 2010	Guo JJ, Pandey S, Doyle J, Bian B, Lis Y, Raisch DW: A review of quantitative risk-benefit methodologies for assessing drug safety and efficacy-report of the ISPOR risk-benefit management working group. Value Health 2010;13:657-66. PMID: 20412543	Link FT	新薬の認可の際に定量的な益と害の評価（quantitative risk-benefit assessment (RBA)）はあまり行われていない。RBAの方法について調査。ISPOR　WG。2012年のAHRQの報告書にはすべて取り上げられている方法。。
21	Bossuyt PMM 2009	Bossuyt PMM, McCaffery K: Medical Tests-White Paper Series. AHRQ Methods for Effective Health Care 2009; (book) PMID: 21290780	Link FT
22	Sullivan PW 2006	Sullivan PW, Ghushchyan V: Mapping the EQ-5D index from the SF-12: US general population preferences in a nationally representative sample. Med Decis Making 2006;26:401-9. PMID: 16855128	Link FT	費用対効果分析のためのアメリカの一般人口のUtilityをSF-12、EQ-5D質問票で測定。
23	Sullivan PW 2006	Sullivan PW, Ghushchyan V: Preference-Based EQ-5D index scores for chronic conditions in the United States. Med Decis Making 2006;26:410-20. PMID: 16855129	Link FT
24	Jardine C 2003	Jardine C, Hrudey S, Shortreed J, Craig L, Krewski D, Furgal C, McColl S: Risk management frameworks for human health and environmental risks. J Toxicol Environ Health B Crit Rev 2003;6:569-720. PMID: 14698953	Link
25	Djulbegovic B 2000	Djulbegovic B, Hozo I, Lyman GH: Linking evidence-based medicine therapeutic summary measures to clinical decision analysis. MedGenMed 2000;2:E6. PMID: 11104452	Link FT	MedScape:NNT/NNHを指標とすることを提案。アウトカムの重要性の重みづけをしていない。同じアウトカムの場合に限定。（古い）Medscapeの文書。
26	Gail MH 1999	Gail MH, Costantino JP, Bryant J, Croyle R, Freedman L, Helzlsouer K, Vogel V: Weighing the risks and benefits of tamoxifen treatment for preventing breast cancer. J Natl Cancer Inst 1999;91:1829-46. PMID: 10547390	Link	Gail/NCI法の最初の論文。
27	Froberg DG 1989	Froberg DG, Kane RL: Methodology for measuring health-state preferences--II: Scaling methods. J Clin Epidemiol 1989;42:459-71. PMID: 2732774	Link
28	Froberg DG 1989	Froberg DG, Kane RL: Methodology for measuring health-state preferences--I: Measurement strategies. J Clin Epidemiol 1989;42:345-54. PMID: 2723695	Link
29	Froberg DG 1989	Froberg DG, Kane RL: Methodology for measuring health-state preferences--IV: Progress and a research agenda. J Clin Epidemiol 1989;42:675-85. PMID: 2668450	Link
30	Froberg DG 1989	Froberg DG, Kane RL: Methodology for measuring health-state preferences--III: Population and context effects. J Clin Epidemiol 1989;42:585-92. PMID: 2661731	Link
31	Wen S 2014	Wen S, Zhang L, Yang B: Two approaches to incorporate clinical data uncertainty into multiple criteria decision analysis for benefit-risk assessment of medicinal products. Value Health 2014;17:619-28. PMID: 25128056	Link FT	☆☆☆δ-method approachおよびMonte-Carlo approachによるEuropean Medicines Agencyの推奨するPrOACT-URL frameworkとMCDA modelによるB-R scores (Benefit-Risk scores, net benefitの定量的評価法。具体的数式モデル、および効果指標の間の相関をVariance-covariance matrixを用いて取り込む方法が記述されている。実例も示されている。
32	Sainfort F 2013	Sainfort F, Kuntz KM, Gregory S, Butler M, Taylor BC, Kulasingam S, Kane RL: Adding decision models to systematic reviews: informing a framework for deciding when and how to do so. Value Health 2013;16:133-9. PMID: 23337224	Link FT
33	Hallgreen CE 2014	Hallgreen CE, van den Ham HA, Mt-Isa S, Ashworth S, Hermann R, Hobbiger S, Luciani D, Micaleff A, Thomson A, Wang N, van Staa TP, Downey G, Hirsch I, Hockley K, Juhaeri J, Metcalf M, Mwangi J, Nixon R, Peters R, Stoeckert I, Waddingham E, Tzoulaki I, Ashby D, Wise L: Benefit-risk assessment in a post-market setting: a case study integrating real-life experience into benefit-risk methodology. Pharmacoepidemiol Drug Saf 2014;23:974-83. PMID: 25043919	Link FT