A modeling approach to derive baseline risk estimates for GRADE recommendations: Concepts, development, and results of its application to the American Society of Hematology 2019 guidelines on prevention of venous thromboembolism in surgical hospitalized patients

Gian Paolo Morgano; Wojtek Wiercioch; David R. Anderson; Jan L. Brożek; Nancy Santesso; Feng Xie; Adam Cuker; Robby Nieuwlaat; Elie A. Akl; Andrea J. Darzi; Juan José Yepes-Nuñez; Itziar Exteandia-Ikobaltzeta; Maryam Rahman; Anita Rajasekhar; Frederick Rogers; Kari A.O. Tikkinen; Adolph J. Yates; Philipp Dahm; Holger J. Schünemann

doi:10.1016/j.jclinepi.2021.07.010

A modeling approach to derive baseline risk estimates for GRADE recommendations: Concepts, development, and results of its application to the American Society of Hematology 2019 guidelines on prevention of venous thromboembolism in surgical hospitalized patients

Gian Paolo Morgano, Wojtek Wiercioch, David R. Anderson, Jan L. Brożek, Nancy Santesso, Feng Xie, Adam Cuker, Robby Nieuwlaat, Elie A. Akl, Andrea J. Darzi, Juan José Yepes-Nuñez, Itziar Exteandia-Ikobaltzeta, Maryam Rahman, Anita Rajasekhar, Frederick Rogers, Kari A.O. Tikkinen, Adolph J. Yates, Philipp Dahm, Holger J. Schünemann

Medicine

Medicine

Producción científica: Contribución a una revista › Artículo › revisión exhaustiva

Resumen

Objective: The goal of this study was to develop an approach that can be used where baseline risk estimates that are directly applicable to prioritized patient-important outcomes are not available from published studies. Study design: The McMaster University GRADE Centre and the ASH guideline panel for the prevention of VTE in surgical patients developed a modeling approach based on explicit assumptions about the distribution of symptoms, anatomical location, and severity of VTE events. Results: We applied the approach to derive modeled estimates of baseline risk. These estimates were used to calculated absolute measures of anticipated effects that informed the discussion of the evidence and the formulation of 30 guideline recommendations. Conclusion: Our approach can assist guideline developers facing a lack of information about baseline risk estimates that directly apply to outcomes of interest. The use of modeled estimates increases transparency in the process and makes the baseline risk used by guideline experts explicit during their decision-making.

Idioma original	English
Páginas (desde-hasta)	69-78
Número de páginas	10
Publicación	Journal of Clinical Epidemiology
Volumen	140
DOI	https://doi.org/10.1016/j.jclinepi.2021.07.010
Estado	Published - dic. 2021

Nota bibliográfica

Funding Information:
Contribution: G.P.M. wrote the first draft of the manuscript and revised the manuscript based on authors’ suggestions; H.J.S. conceptualized the modeling approach and guided its development; W.W. and H.J.S contributed to drafting and critical revisions of the manuscript; D.R.A. and P.D. were the chair and vice-chair of the panel, led the panel meetings, facilitated the development of assumptions and the application of the model; J.L.B. N.S. and F.X. critically reviewed the model providing methodological input; G.P.M. and H.J.S. performed initial selection of the sources of baseline risk for all guideline questions for review by the chair and vice-chair of the panel; G.P.M. W.W. I.E.I, J.J.Y.N. lead the review of the evidence used to inform the guideline and calculated modeled estimates of baseline risk; A.D. and E.A. conducted the systematic searches for prognosis data and defined its selection criteria; D.A. P.D. M.R. A.R. K.A.O.T, F.R. and A.J.Y. were members of the panel and provided expert evidence for the development of assumptions. H.J.S. A.C. R.N. and W.W. verified that the methods described in this manuscript are consistent with what was used in the ASH 2019 guidelines on prevention of venous thromboembolism in surgical hospitalized patients. All of the authors revised the manuscript critically for important intellectual content and approved the final version submitted for publication. Gian Paolo Morgano: Conceptualization, Methodology, Formal analysis, Investigation, Writing - Original Draft, Visualization, Project administration Wojtek Wiercioch: Conceptualization, Methodology, Investigation, Writing - Review & Editing Robby Nieuwlaat: Methodology, Investigation, Writing - Review & Editing, Project administration Philipp Dahm: Investigation, Writing - Review & Editing David R. Anderson: Investigation, Writing - Review & Editing Jan L. Brożek: Investigation, Writing - Review & Editing Nancy Santesso: Investigation, Writing - Review & Editing Feng Xie: Investigation, Writing - Review & Editing Adam Cuker: Investigation, Writing - Review & Editing Elie A. Akl: Investigation, Writing - Review & Editing Andrea Darzi: Investigation, Writing - Review & Editing Juan José Yepes-Nuñez: Investigation, Writing - Review & Editing Itziar Exteandia-Ikobaltzeta: Investigation, Writing - Review & Editing Maryam Rahman: Investigation, Writing - Review & Editing Anita Rajasekhar: Investigation, Writing - Review & Editing Frederick Rogers: Investigation, Writing - Review & Editing Kari A. O. Tikkinen: Investigation, Writing - Review & Editing Adolph J. Yates: Investigation, Writing - Review & Editing Philipp Dahm: Investigation, Writing - Review & Editing Holger J. Schünemann: Conceptualization, Methodology, Investigation, Resources, Writing - Review & Editing, Supervision, Project administration, Funding acquisition. Not required. This study does not involve de novo patient data collection. No patient informed consent and Institutional Review Board approval have been sought. The Excel spreadsheet used to calculate modeled baseline risk from surrogate baseline risk estimates is available upon request.

Publisher Copyright:
© 2021 Elsevier Inc.

ASJC Scopus Subject Areas

Epidemiology

PubMed: MeSH publication types

Journal Article
Practice Guideline

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10.1016/j.jclinepi.2021.07.010

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Morgano, G. P., Wiercioch, W., Anderson, D. R., Brożek, J. L., Santesso, N., Xie, F., Cuker, A., Nieuwlaat, R., Akl, E. A., Darzi, A. J., Yepes-Nuñez, J. J., Exteandia-Ikobaltzeta, I., Rahman, M., Rajasekhar, A., Rogers, F., Tikkinen, K. A. O., Yates, A. J., Dahm, P., & Schünemann, H. J. (2021). A modeling approach to derive baseline risk estimates for GRADE recommendations: Concepts, development, and results of its application to the American Society of Hematology 2019 guidelines on prevention of venous thromboembolism in surgical hospitalized patients. Journal of Clinical Epidemiology, 140, 69-78. https://doi.org/10.1016/j.jclinepi.2021.07.010

A modeling approach to derive baseline risk estimates for GRADE recommendations: Concepts, development, and results of its application to the American Society of Hematology 2019 guidelines on prevention of venous thromboembolism in surgical hospitalized patients. / Morgano, Gian Paolo; Wiercioch, Wojtek; Anderson, David R. et al.
En: Journal of Clinical Epidemiology, Vol. 140, 12.2021, p. 69-78.

Producción científica: Contribución a una revista › Artículo › revisión exhaustiva

Morgano, GP, Wiercioch, W, Anderson, DR, Brożek, JL, Santesso, N, Xie, F, Cuker, A, Nieuwlaat, R, Akl, EA, Darzi, AJ, Yepes-Nuñez, JJ, Exteandia-Ikobaltzeta, I, Rahman, M, Rajasekhar, A, Rogers, F, Tikkinen, KAO, Yates, AJ, Dahm, P & Schünemann, HJ 2021, 'A modeling approach to derive baseline risk estimates for GRADE recommendations: Concepts, development, and results of its application to the American Society of Hematology 2019 guidelines on prevention of venous thromboembolism in surgical hospitalized patients', Journal of Clinical Epidemiology, vol. 140, pp. 69-78. https://doi.org/10.1016/j.jclinepi.2021.07.010

Morgano GP, Wiercioch W, Anderson DR, Brożek JL, Santesso N, Xie F et al. A modeling approach to derive baseline risk estimates for GRADE recommendations: Concepts, development, and results of its application to the American Society of Hematology 2019 guidelines on prevention of venous thromboembolism in surgical hospitalized patients. Journal of Clinical Epidemiology. 2021 dic.;140:69-78. doi: 10.1016/j.jclinepi.2021.07.010

Morgano, Gian Paolo ; Wiercioch, Wojtek ; Anderson, David R. et al. / A modeling approach to derive baseline risk estimates for GRADE recommendations : Concepts, development, and results of its application to the American Society of Hematology 2019 guidelines on prevention of venous thromboembolism in surgical hospitalized patients. En: Journal of Clinical Epidemiology. 2021 ; Vol. 140. pp. 69-78.

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abstract = "Objective: The goal of this study was to develop an approach that can be used where baseline risk estimates that are directly applicable to prioritized patient-important outcomes are not available from published studies. Study design: The McMaster University GRADE Centre and the ASH guideline panel for the prevention of VTE in surgical patients developed a modeling approach based on explicit assumptions about the distribution of symptoms, anatomical location, and severity of VTE events. Results: We applied the approach to derive modeled estimates of baseline risk. These estimates were used to calculated absolute measures of anticipated effects that informed the discussion of the evidence and the formulation of 30 guideline recommendations. Conclusion: Our approach can assist guideline developers facing a lack of information about baseline risk estimates that directly apply to outcomes of interest. The use of modeled estimates increases transparency in the process and makes the baseline risk used by guideline experts explicit during their decision-making.",

author = "Morgano, {Gian Paolo} and Wojtek Wiercioch and Anderson, {David R.} and Bro{\.z}ek, {Jan L.} and Nancy Santesso and Feng Xie and Adam Cuker and Robby Nieuwlaat and Akl, {Elie A.} and Darzi, {Andrea J.} and Yepes-Nu{\~n}ez, {Juan Jos{\'e}} and Itziar Exteandia-Ikobaltzeta and Maryam Rahman and Anita Rajasekhar and Frederick Rogers and Tikkinen, {Kari A.O.} and Yates, {Adolph J.} and Philipp Dahm and Sch{\"u}nemann, {Holger J.}",

note = "Funding Information: Contribution: G.P.M. wrote the first draft of the manuscript and revised the manuscript based on authors{\textquoteright} suggestions; H.J.S. conceptualized the modeling approach and guided its development; W.W. and H.J.S contributed to drafting and critical revisions of the manuscript; D.R.A. and P.D. were the chair and vice-chair of the panel, led the panel meetings, facilitated the development of assumptions and the application of the model; J.L.B. N.S. and F.X. critically reviewed the model providing methodological input; G.P.M. and H.J.S. performed initial selection of the sources of baseline risk for all guideline questions for review by the chair and vice-chair of the panel; G.P.M. W.W. I.E.I, J.J.Y.N. lead the review of the evidence used to inform the guideline and calculated modeled estimates of baseline risk; A.D. and E.A. conducted the systematic searches for prognosis data and defined its selection criteria; D.A. P.D. M.R. A.R. K.A.O.T, F.R. and A.J.Y. were members of the panel and provided expert evidence for the development of assumptions. H.J.S. A.C. R.N. and W.W. verified that the methods described in this manuscript are consistent with what was used in the ASH 2019 guidelines on prevention of venous thromboembolism in surgical hospitalized patients. All of the authors revised the manuscript critically for important intellectual content and approved the final version submitted for publication. Gian Paolo Morgano: Conceptualization, Methodology, Formal analysis, Investigation, Writing - Original Draft, Visualization, Project administration Wojtek Wiercioch: Conceptualization, Methodology, Investigation, Writing - Review & Editing Robby Nieuwlaat: Methodology, Investigation, Writing - Review & Editing, Project administration Philipp Dahm: Investigation, Writing - Review & Editing David R. Anderson: Investigation, Writing - Review & Editing Jan L. Bro{\.z}ek: Investigation, Writing - Review & Editing Nancy Santesso: Investigation, Writing - Review & Editing Feng Xie: Investigation, Writing - Review & Editing Adam Cuker: Investigation, Writing - Review & Editing Elie A. Akl: Investigation, Writing - Review & Editing Andrea Darzi: Investigation, Writing - Review & Editing Juan Jos{\'e} Yepes-Nu{\~n}ez: Investigation, Writing - Review & Editing Itziar Exteandia-Ikobaltzeta: Investigation, Writing - Review & Editing Maryam Rahman: Investigation, Writing - Review & Editing Anita Rajasekhar: Investigation, Writing - Review & Editing Frederick Rogers: Investigation, Writing - Review & Editing Kari A. O. Tikkinen: Investigation, Writing - Review & Editing Adolph J. Yates: Investigation, Writing - Review & Editing Philipp Dahm: Investigation, Writing - Review & Editing Holger J. Sch{\"u}nemann: Conceptualization, Methodology, Investigation, Resources, Writing - Review & Editing, Supervision, Project administration, Funding acquisition. Not required. This study does not involve de novo patient data collection. No patient informed consent and Institutional Review Board approval have been sought. The Excel spreadsheet used to calculate modeled baseline risk from surrogate baseline risk estimates is available upon request. Publisher Copyright: {\textcopyright} 2021 Elsevier Inc.",

year = "2021",

month = dec,

doi = "10.1016/j.jclinepi.2021.07.010",

language = "English",

volume = "140",

pages = "69--78",

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T1 - A modeling approach to derive baseline risk estimates for GRADE recommendations

T2 - Concepts, development, and results of its application to the American Society of Hematology 2019 guidelines on prevention of venous thromboembolism in surgical hospitalized patients

AU - Morgano, Gian Paolo

AU - Wiercioch, Wojtek

AU - Anderson, David R.

AU - Brożek, Jan L.

AU - Santesso, Nancy

AU - Xie, Feng

AU - Cuker, Adam

AU - Nieuwlaat, Robby

AU - Akl, Elie A.

AU - Darzi, Andrea J.

AU - Yepes-Nuñez, Juan José

AU - Exteandia-Ikobaltzeta, Itziar

AU - Rahman, Maryam

AU - Rajasekhar, Anita

AU - Rogers, Frederick

AU - Tikkinen, Kari A.O.

AU - Yates, Adolph J.

AU - Dahm, Philipp

AU - Schünemann, Holger J.

N1 - Funding Information: Contribution: G.P.M. wrote the first draft of the manuscript and revised the manuscript based on authors’ suggestions; H.J.S. conceptualized the modeling approach and guided its development; W.W. and H.J.S contributed to drafting and critical revisions of the manuscript; D.R.A. and P.D. were the chair and vice-chair of the panel, led the panel meetings, facilitated the development of assumptions and the application of the model; J.L.B. N.S. and F.X. critically reviewed the model providing methodological input; G.P.M. and H.J.S. performed initial selection of the sources of baseline risk for all guideline questions for review by the chair and vice-chair of the panel; G.P.M. W.W. I.E.I, J.J.Y.N. lead the review of the evidence used to inform the guideline and calculated modeled estimates of baseline risk; A.D. and E.A. conducted the systematic searches for prognosis data and defined its selection criteria; D.A. P.D. M.R. A.R. K.A.O.T, F.R. and A.J.Y. were members of the panel and provided expert evidence for the development of assumptions. H.J.S. A.C. R.N. and W.W. verified that the methods described in this manuscript are consistent with what was used in the ASH 2019 guidelines on prevention of venous thromboembolism in surgical hospitalized patients. All of the authors revised the manuscript critically for important intellectual content and approved the final version submitted for publication. Gian Paolo Morgano: Conceptualization, Methodology, Formal analysis, Investigation, Writing - Original Draft, Visualization, Project administration Wojtek Wiercioch: Conceptualization, Methodology, Investigation, Writing - Review & Editing Robby Nieuwlaat: Methodology, Investigation, Writing - Review & Editing, Project administration Philipp Dahm: Investigation, Writing - Review & Editing David R. Anderson: Investigation, Writing - Review & Editing Jan L. Brożek: Investigation, Writing - Review & Editing Nancy Santesso: Investigation, Writing - Review & Editing Feng Xie: Investigation, Writing - Review & Editing Adam Cuker: Investigation, Writing - Review & Editing Elie A. Akl: Investigation, Writing - Review & Editing Andrea Darzi: Investigation, Writing - Review & Editing Juan José Yepes-Nuñez: Investigation, Writing - Review & Editing Itziar Exteandia-Ikobaltzeta: Investigation, Writing - Review & Editing Maryam Rahman: Investigation, Writing - Review & Editing Anita Rajasekhar: Investigation, Writing - Review & Editing Frederick Rogers: Investigation, Writing - Review & Editing Kari A. O. Tikkinen: Investigation, Writing - Review & Editing Adolph J. Yates: Investigation, Writing - Review & Editing Philipp Dahm: Investigation, Writing - Review & Editing Holger J. Schünemann: Conceptualization, Methodology, Investigation, Resources, Writing - Review & Editing, Supervision, Project administration, Funding acquisition. Not required. This study does not involve de novo patient data collection. No patient informed consent and Institutional Review Board approval have been sought. The Excel spreadsheet used to calculate modeled baseline risk from surrogate baseline risk estimates is available upon request. Publisher Copyright: © 2021 Elsevier Inc.

PY - 2021/12

Y1 - 2021/12

N2 - Objective: The goal of this study was to develop an approach that can be used where baseline risk estimates that are directly applicable to prioritized patient-important outcomes are not available from published studies. Study design: The McMaster University GRADE Centre and the ASH guideline panel for the prevention of VTE in surgical patients developed a modeling approach based on explicit assumptions about the distribution of symptoms, anatomical location, and severity of VTE events. Results: We applied the approach to derive modeled estimates of baseline risk. These estimates were used to calculated absolute measures of anticipated effects that informed the discussion of the evidence and the formulation of 30 guideline recommendations. Conclusion: Our approach can assist guideline developers facing a lack of information about baseline risk estimates that directly apply to outcomes of interest. The use of modeled estimates increases transparency in the process and makes the baseline risk used by guideline experts explicit during their decision-making.

AB - Objective: The goal of this study was to develop an approach that can be used where baseline risk estimates that are directly applicable to prioritized patient-important outcomes are not available from published studies. Study design: The McMaster University GRADE Centre and the ASH guideline panel for the prevention of VTE in surgical patients developed a modeling approach based on explicit assumptions about the distribution of symptoms, anatomical location, and severity of VTE events. Results: We applied the approach to derive modeled estimates of baseline risk. These estimates were used to calculated absolute measures of anticipated effects that informed the discussion of the evidence and the formulation of 30 guideline recommendations. Conclusion: Our approach can assist guideline developers facing a lack of information about baseline risk estimates that directly apply to outcomes of interest. The use of modeled estimates increases transparency in the process and makes the baseline risk used by guideline experts explicit during their decision-making.

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