Evidence map›Paper›PMID 32778601›Full record

ArticleCMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne2020

Development of the Instrument to assess the Credibility of Effect Modification Analyses (ICEMAN) in randomized controlled trials and meta-analyses.

Stefan Schandelmaier, Matthias Briel, Ravi Varadhan, Christopher H Schmid, Niveditha Devasenapathy, Rodney A Hayward, Joel Gagnier, Michael Borenstein, Geert J M G van der Heijden, Issa J Dahabreh and 6 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06840756 (Effects of Donor-recipient Sex-matched Versus Sex-mismatched Red Blood Cell Transfusion on Outcomes in Critically Ill Adult Patients), which is not on this map. Cited by 343 papers, 78 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
343citing papers in PubMed, 78 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06840756 phase4recruitingnot on this mapstarted 2025, after this paper: background citation

Effects of Donor-recipient Sex-matched Versus Sex-mismatched Red Blood Cell Transfusion on Outcomes in Critically Ill Adult Patients

TypeinterventionalSponsorMichelle ZellerRan2025 to 2029Enrolled11,082ConditionsRed Blood Cell Transfusions, Sex Differences, Health Services, Critically Ill Intensive Care Unit PatientsArmsSex-mismatched red blood cell transfusions, Sex-matched red blood cell transfusions
3 · Its place in the literature

Who cites it

343 citing papers in PubMed, 78 syntheses or guidelines pooled it.

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  6. Cognitive Behavioral Interventions for Children and Adolescents With Overweight or Obesity: A Systematic Review and Component Network Meta-Analysis.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2026
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283 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Stefan SchandelmaierDepartments of Health Research Methods, Evidence, and Impact (Schandelmaier, Briel, Walsh, Thabane, Guyatt), Medicine (Walsh, Guyatt), Pediatrics (Thabane) and Anesthesia (Thabane), McMaster University, Hamilton, Ont.; Institute for Clinical Epidemiology and Biostatistics (Schandelmaier, Briel), Department of Clinical Research, Basel University, Basel, Switzerland; Division of Biostatistics and Bioinformatics (Varadhan), Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Md.; Department of Biostatistics (Schmid), Brown University School of Public Health, Brown University, Providence, RI; Indian institute of Public Health-Delhi (Devasenapathy), Public Health Foundation of India, New Delhi, India; VA Center for Clinical Management and Research (Hayward); Department of Internal Medicine (Hayward), University of Michigan School of Medicine; Department of Orthopaedic Surgery (Gagnier), University of Michigan; Department of Epidemiology (Gagnier), School of Public Health, University of Michigan, Ann Arbor, Mich.; Biostat (Borenstein), Englewood, NJ; Department of Social Dentistry (van der Heijden), Academic Center for Dentistry Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, Netherlands; Center for Evidence Synthesis in Health (Dahabreh) and Departments of Health Services, Policy, and Practice (Dahabreh) and Epidemiology (Dahabreh), School of Public Health, Brown University, Providence, RI; Chinese Evidence-Based Medicine Center (Sun), West China Hospital, Sichuan University, Chengdu, China; Institute of Medical Biometry and Statistics (Sauerbrei), Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany; Population Health Research Institute (Walsh), Hamilton Health Sciences/McMaster University, Hamilton, Ont.; Departments of Medicine (Ioannidis), Health Research and Policy (Ioannidis) and Biomedical Data Science (Ioannidis), and Statistics and Meta-Research Innovation Center at Stanford (METRICS) (Ioannidis), Stanford University, Stanford, Calif.; Biostatistics Unit (Thabane), St. Joseph's Healthcare, Hamilton, Ont. s.schandelmaier@gmail.com.
Matthias BrielDepartments of Health Research Methods, Evidence, and Impact (Schandelmaier, Briel, Walsh, Thabane, Guyatt), Medicine (Walsh, Guyatt), Pediatrics (Thabane) and Anesthesia (Thabane), McMaster University, Hamilton, Ont.; Institute for Clinical Epidemiology and Biostatistics (Schandelmaier, Briel), Department of Clinical Research, Basel University, Basel, Switzerland; Division of Biostatistics and Bioinformatics (Varadhan), Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Md.; Department of Biostatistics (Schmid), Brown University School of Public Health, Brown University, Providence, RI; Indian institute of Public Health-Delhi (Devasenapathy), Public Health Foundation of India, New Delhi, India; VA Center for Clinical Management and Research (Hayward); Department of Internal Medicine (Hayward), University of Michigan School of Medicine; Department of Orthopaedic Surgery (Gagnier), University of Michigan; Department of Epidemiology (Gagnier), School of Public Health, University of Michigan, Ann Arbor, Mich.; Biostat (Borenstein), Englewood, NJ; Department of Social Dentistry (van der Heijden), Academic Center for Dentistry Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, Netherlands; Center for Evidence Synthesis in Health (Dahabreh) and Departments of Health Services, Policy, and Practice (Dahabreh) and Epidemiology (Dahabreh), School of Public Health, Brown University, Providence, RI; Chinese Evidence-Based Medicine Center (Sun), West China Hospital, Sichuan University, Chengdu, China; Institute of Medical Biometry and Statistics (Sauerbrei), Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany; Population Health Research Institute (Walsh), Hamilton Health Sciences/McMaster University, Hamilton, Ont.; Departments of Medicine (Ioannidis), Health Research and Policy (Ioannidis) and Biomedical Data Science (Ioannidis), and Statistics and Meta-Research Innovation Center at Stanford (METRICS) (Ioannidis), Stanford University, Stanford, Calif.; Biostatistics Unit (Thabane), St. Joseph's Healthcare, Hamilton, Ont.
Ravi VaradhanDepartments of Health Research Methods, Evidence, and Impact (Schandelmaier, Briel, Walsh, Thabane, Guyatt), Medicine (Walsh, Guyatt), Pediatrics (Thabane) and Anesthesia (Thabane), McMaster University, Hamilton, Ont.; Institute for Clinical Epidemiology and Biostatistics (Schandelmaier, Briel), Department of Clinical Research, Basel University, Basel, Switzerland; Division of Biostatistics and Bioinformatics (Varadhan), Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Md.; Department of Biostatistics (Schmid), Brown University School of Public Health, Brown University, Providence, RI; Indian institute of Public Health-Delhi (Devasenapathy), Public Health Foundation of India, New Delhi, India; VA Center for Clinical Management and Research (Hayward); Department of Internal Medicine (Hayward), University of Michigan School of Medicine; Department of Orthopaedic Surgery (Gagnier), University of Michigan; Department of Epidemiology (Gagnier), School of Public Health, University of Michigan, Ann Arbor, Mich.; Biostat (Borenstein), Englewood, NJ; Department of Social Dentistry (van der Heijden), Academic Center for Dentistry Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, Netherlands; Center for Evidence Synthesis in Health (Dahabreh) and Departments of Health Services, Policy, and Practice (Dahabreh) and Epidemiology (Dahabreh), School of Public Health, Brown University, Providence, RI; Chinese Evidence-Based Medicine Center (Sun), West China Hospital, Sichuan University, Chengdu, China; Institute of Medical Biometry and Statistics (Sauerbrei), Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany; Population Health Research Institute (Walsh), Hamilton Health Sciences/McMaster University, Hamilton, Ont.; Departments of Medicine (Ioannidis), Health Research and Policy (Ioannidis) and Biomedical Data Science (Ioannidis), and Statistics and Meta-Research Innovation Center at Stanford (METRICS) (Ioannidis), Stanford University, Stanford, Calif.; Biostatistics Unit (Thabane), St. Joseph's Healthcare, Hamilton, Ont.
Christopher H SchmidDepartments of Health Research Methods, Evidence, and Impact (Schandelmaier, Briel, Walsh, Thabane, Guyatt), Medicine (Walsh, Guyatt), Pediatrics (Thabane) and Anesthesia (Thabane), McMaster University, Hamilton, Ont.; Institute for Clinical Epidemiology and Biostatistics (Schandelmaier, Briel), Department of Clinical Research, Basel University, Basel, Switzerland; Division of Biostatistics and Bioinformatics (Varadhan), Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Md.; Department of Biostatistics (Schmid), Brown University School of Public Health, Brown University, Providence, RI; Indian institute of Public Health-Delhi (Devasenapathy), Public Health Foundation of India, New Delhi, India; VA Center for Clinical Management and Research (Hayward); Department of Internal Medicine (Hayward), University of Michigan School of Medicine; Department of Orthopaedic Surgery (Gagnier), University of Michigan; Department of Epidemiology (Gagnier), School of Public Health, University of Michigan, Ann Arbor, Mich.; Biostat (Borenstein), Englewood, NJ; Department of Social Dentistry (van der Heijden), Academic Center for Dentistry Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, Netherlands; Center for Evidence Synthesis in Health (Dahabreh) and Departments of Health Services, Policy, and Practice (Dahabreh) and Epidemiology (Dahabreh), School of Public Health, Brown University, Providence, RI; Chinese Evidence-Based Medicine Center (Sun), West China Hospital, Sichuan University, Chengdu, China; Institute of Medical Biometry and Statistics (Sauerbrei), Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany; Population Health Research Institute (Walsh), Hamilton Health Sciences/McMaster University, Hamilton, Ont.; Departments of Medicine (Ioannidis), Health Research and Policy (Ioannidis) and Biomedical Data Science (Ioannidis), and Statistics and Meta-Research Innovation Center at Stanford (METRICS) (Ioannidis), Stanford University, Stanford, Calif.; Biostatistics Unit (Thabane), St. Joseph's Healthcare, Hamilton, Ont.
Niveditha DevasenapathyDepartments of Health Research Methods, Evidence, and Impact (Schandelmaier, Briel, Walsh, Thabane, Guyatt), Medicine (Walsh, Guyatt), Pediatrics (Thabane) and Anesthesia (Thabane), McMaster University, Hamilton, Ont.; Institute for Clinical Epidemiology and Biostatistics (Schandelmaier, Briel), Department of Clinical Research, Basel University, Basel, Switzerland; Division of Biostatistics and Bioinformatics (Varadhan), Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Md.; Department of Biostatistics (Schmid), Brown University School of Public Health, Brown University, Providence, RI; Indian institute of Public Health-Delhi (Devasenapathy), Public Health Foundation of India, New Delhi, India; VA Center for Clinical Management and Research (Hayward); Department of Internal Medicine (Hayward), University of Michigan School of Medicine; Department of Orthopaedic Surgery (Gagnier), University of Michigan; Department of Epidemiology (Gagnier), School of Public Health, University of Michigan, Ann Arbor, Mich.; Biostat (Borenstein), Englewood, NJ; Department of Social Dentistry (van der Heijden), Academic Center for Dentistry Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, Netherlands; Center for Evidence Synthesis in Health (Dahabreh) and Departments of Health Services, Policy, and Practice (Dahabreh) and Epidemiology (Dahabreh), School of Public Health, Brown University, Providence, RI; Chinese Evidence-Based Medicine Center (Sun), West China Hospital, Sichuan University, Chengdu, China; Institute of Medical Biometry and Statistics (Sauerbrei), Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany; Population Health Research Institute (Walsh), Hamilton Health Sciences/McMaster University, Hamilton, Ont.; Departments of Medicine (Ioannidis), Health Research and Policy (Ioannidis) and Biomedical Data Science (Ioannidis), and Statistics and Meta-Research Innovation Center at Stanford (METRICS) (Ioannidis), Stanford University, Stanford, Calif.; Biostatistics Unit (Thabane), St. Joseph's Healthcare, Hamilton, Ont.
Rodney A HaywardDepartments of Health Research Methods, Evidence, and Impact (Schandelmaier, Briel, Walsh, Thabane, Guyatt), Medicine (Walsh, Guyatt), Pediatrics (Thabane) and Anesthesia (Thabane), McMaster University, Hamilton, Ont.; Institute for Clinical Epidemiology and Biostatistics (Schandelmaier, Briel), Department of Clinical Research, Basel University, Basel, Switzerland; Division of Biostatistics and Bioinformatics (Varadhan), Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Md.; Department of Biostatistics (Schmid), Brown University School of Public Health, Brown University, Providence, RI; Indian institute of Public Health-Delhi (Devasenapathy), Public Health Foundation of India, New Delhi, India; VA Center for Clinical Management and Research (Hayward); Department of Internal Medicine (Hayward), University of Michigan School of Medicine; Department of Orthopaedic Surgery (Gagnier), University of Michigan; Department of Epidemiology (Gagnier), School of Public Health, University of Michigan, Ann Arbor, Mich.; Biostat (Borenstein), Englewood, NJ; Department of Social Dentistry (van der Heijden), Academic Center for Dentistry Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, Netherlands; Center for Evidence Synthesis in Health (Dahabreh) and Departments of Health Services, Policy, and Practice (Dahabreh) and Epidemiology (Dahabreh), School of Public Health, Brown University, Providence, RI; Chinese Evidence-Based Medicine Center (Sun), West China Hospital, Sichuan University, Chengdu, China; Institute of Medical Biometry and Statistics (Sauerbrei), Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany; Population Health Research Institute (Walsh), Hamilton Health Sciences/McMaster University, Hamilton, Ont.; Departments of Medicine (Ioannidis), Health Research and Policy (Ioannidis) and Biomedical Data Science (Ioannidis), and Statistics and Meta-Research Innovation Center at Stanford (METRICS) (Ioannidis), Stanford University, Stanford, Calif.; Biostatistics Unit (Thabane), St. Joseph's Healthcare, Hamilton, Ont.
Joel GagnierDepartments of Health Research Methods, Evidence, and Impact (Schandelmaier, Briel, Walsh, Thabane, Guyatt), Medicine (Walsh, Guyatt), Pediatrics (Thabane) and Anesthesia (Thabane), McMaster University, Hamilton, Ont.; Institute for Clinical Epidemiology and Biostatistics (Schandelmaier, Briel), Department of Clinical Research, Basel University, Basel, Switzerland; Division of Biostatistics and Bioinformatics (Varadhan), Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Md.; Department of Biostatistics (Schmid), Brown University School of Public Health, Brown University, Providence, RI; Indian institute of Public Health-Delhi (Devasenapathy), Public Health Foundation of India, New Delhi, India; VA Center for Clinical Management and Research (Hayward); Department of Internal Medicine (Hayward), University of Michigan School of Medicine; Department of Orthopaedic Surgery (Gagnier), University of Michigan; Department of Epidemiology (Gagnier), School of Public Health, University of Michigan, Ann Arbor, Mich.; Biostat (Borenstein), Englewood, NJ; Department of Social Dentistry (van der Heijden), Academic Center for Dentistry Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, Netherlands; Center for Evidence Synthesis in Health (Dahabreh) and Departments of Health Services, Policy, and Practice (Dahabreh) and Epidemiology (Dahabreh), School of Public Health, Brown University, Providence, RI; Chinese Evidence-Based Medicine Center (Sun), West China Hospital, Sichuan University, Chengdu, China; Institute of Medical Biometry and Statistics (Sauerbrei), Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany; Population Health Research Institute (Walsh), Hamilton Health Sciences/McMaster University, Hamilton, Ont.; Departments of Medicine (Ioannidis), Health Research and Policy (Ioannidis) and Biomedical Data Science (Ioannidis), and Statistics and Meta-Research Innovation Center at Stanford (METRICS) (Ioannidis), Stanford University, Stanford, Calif.; Biostatistics Unit (Thabane), St. Joseph's Healthcare, Hamilton, Ont.
Michael BorensteinDepartments of Health Research Methods, Evidence, and Impact (Schandelmaier, Briel, Walsh, Thabane, Guyatt), Medicine (Walsh, Guyatt), Pediatrics (Thabane) and Anesthesia (Thabane), McMaster University, Hamilton, Ont.; Institute for Clinical Epidemiology and Biostatistics (Schandelmaier, Briel), Department of Clinical Research, Basel University, Basel, Switzerland; Division of Biostatistics and Bioinformatics (Varadhan), Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Md.; Department of Biostatistics (Schmid), Brown University School of Public Health, Brown University, Providence, RI; Indian institute of Public Health-Delhi (Devasenapathy), Public Health Foundation of India, New Delhi, India; VA Center for Clinical Management and Research (Hayward); Department of Internal Medicine (Hayward), University of Michigan School of Medicine; Department of Orthopaedic Surgery (Gagnier), University of Michigan; Department of Epidemiology (Gagnier), School of Public Health, University of Michigan, Ann Arbor, Mich.; Biostat (Borenstein), Englewood, NJ; Department of Social Dentistry (van der Heijden), Academic Center for Dentistry Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, Netherlands; Center for Evidence Synthesis in Health (Dahabreh) and Departments of Health Services, Policy, and Practice (Dahabreh) and Epidemiology (Dahabreh), School of Public Health, Brown University, Providence, RI; Chinese Evidence-Based Medicine Center (Sun), West China Hospital, Sichuan University, Chengdu, China; Institute of Medical Biometry and Statistics (Sauerbrei), Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany; Population Health Research Institute (Walsh), Hamilton Health Sciences/McMaster University, Hamilton, Ont.; Departments of Medicine (Ioannidis), Health Research and Policy (Ioannidis) and Biomedical Data Science (Ioannidis), and Statistics and Meta-Research Innovation Center at Stanford (METRICS) (Ioannidis), Stanford University, Stanford, Calif.; Biostatistics Unit (Thabane), St. Joseph's Healthcare, Hamilton, Ont.
Geert J M G van der HeijdenDepartments of Health Research Methods, Evidence, and Impact (Schandelmaier, Briel, Walsh, Thabane, Guyatt), Medicine (Walsh, Guyatt), Pediatrics (Thabane) and Anesthesia (Thabane), McMaster University, Hamilton, Ont.; Institute for Clinical Epidemiology and Biostatistics (Schandelmaier, Briel), Department of Clinical Research, Basel University, Basel, Switzerland; Division of Biostatistics and Bioinformatics (Varadhan), Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Md.; Department of Biostatistics (Schmid), Brown University School of Public Health, Brown University, Providence, RI; Indian institute of Public Health-Delhi (Devasenapathy), Public Health Foundation of India, New Delhi, India; VA Center for Clinical Management and Research (Hayward); Department of Internal Medicine (Hayward), University of Michigan School of Medicine; Department of Orthopaedic Surgery (Gagnier), University of Michigan; Department of Epidemiology (Gagnier), School of Public Health, University of Michigan, Ann Arbor, Mich.; Biostat (Borenstein), Englewood, NJ; Department of Social Dentistry (van der Heijden), Academic Center for Dentistry Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, Netherlands; Center for Evidence Synthesis in Health (Dahabreh) and Departments of Health Services, Policy, and Practice (Dahabreh) and Epidemiology (Dahabreh), School of Public Health, Brown University, Providence, RI; Chinese Evidence-Based Medicine Center (Sun), West China Hospital, Sichuan University, Chengdu, China; Institute of Medical Biometry and Statistics (Sauerbrei), Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany; Population Health Research Institute (Walsh), Hamilton Health Sciences/McMaster University, Hamilton, Ont.; Departments of Medicine (Ioannidis), Health Research and Policy (Ioannidis) and Biomedical Data Science (Ioannidis), and Statistics and Meta-Research Innovation Center at Stanford (METRICS) (Ioannidis), Stanford University, Stanford, Calif.; Biostatistics Unit (Thabane), St. Joseph's Healthcare, Hamilton, Ont.
Issa J DahabrehDepartments of Health Research Methods, Evidence, and Impact (Schandelmaier, Briel, Walsh, Thabane, Guyatt), Medicine (Walsh, Guyatt), Pediatrics (Thabane) and Anesthesia (Thabane), McMaster University, Hamilton, Ont.; Institute for Clinical Epidemiology and Biostatistics (Schandelmaier, Briel), Department of Clinical Research, Basel University, Basel, Switzerland; Division of Biostatistics and Bioinformatics (Varadhan), Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Md.; Department of Biostatistics (Schmid), Brown University School of Public Health, Brown University, Providence, RI; Indian institute of Public Health-Delhi (Devasenapathy), Public Health Foundation of India, New Delhi, India; VA Center for Clinical Management and Research (Hayward); Department of Internal Medicine (Hayward), University of Michigan School of Medicine; Department of Orthopaedic Surgery (Gagnier), University of Michigan; Department of Epidemiology (Gagnier), School of Public Health, University of Michigan, Ann Arbor, Mich.; Biostat (Borenstein), Englewood, NJ; Department of Social Dentistry (van der Heijden), Academic Center for Dentistry Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, Netherlands; Center for Evidence Synthesis in Health (Dahabreh) and Departments of Health Services, Policy, and Practice (Dahabreh) and Epidemiology (Dahabreh), School of Public Health, Brown University, Providence, RI; Chinese Evidence-Based Medicine Center (Sun), West China Hospital, Sichuan University, Chengdu, China; Institute of Medical Biometry and Statistics (Sauerbrei), Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany; Population Health Research Institute (Walsh), Hamilton Health Sciences/McMaster University, Hamilton, Ont.; Departments of Medicine (Ioannidis), Health Research and Policy (Ioannidis) and Biomedical Data Science (Ioannidis), and Statistics and Meta-Research Innovation Center at Stanford (METRICS) (Ioannidis), Stanford University, Stanford, Calif.; Biostatistics Unit (Thabane), St. Joseph's Healthcare, Hamilton, Ont.
Xin SunDepartments of Health Research Methods, Evidence, and Impact (Schandelmaier, Briel, Walsh, Thabane, Guyatt), Medicine (Walsh, Guyatt), Pediatrics (Thabane) and Anesthesia (Thabane), McMaster University, Hamilton, Ont.; Institute for Clinical Epidemiology and Biostatistics (Schandelmaier, Briel), Department of Clinical Research, Basel University, Basel, Switzerland; Division of Biostatistics and Bioinformatics (Varadhan), Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Md.; Department of Biostatistics (Schmid), Brown University School of Public Health, Brown University, Providence, RI; Indian institute of Public Health-Delhi (Devasenapathy), Public Health Foundation of India, New Delhi, India; VA Center for Clinical Management and Research (Hayward); Department of Internal Medicine (Hayward), University of Michigan School of Medicine; Department of Orthopaedic Surgery (Gagnier), University of Michigan; Department of Epidemiology (Gagnier), School of Public Health, University of Michigan, Ann Arbor, Mich.; Biostat (Borenstein), Englewood, NJ; Department of Social Dentistry (van der Heijden), Academic Center for Dentistry Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, Netherlands; Center for Evidence Synthesis in Health (Dahabreh) and Departments of Health Services, Policy, and Practice (Dahabreh) and Epidemiology (Dahabreh), School of Public Health, Brown University, Providence, RI; Chinese Evidence-Based Medicine Center (Sun), West China Hospital, Sichuan University, Chengdu, China; Institute of Medical Biometry and Statistics (Sauerbrei), Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany; Population Health Research Institute (Walsh), Hamilton Health Sciences/McMaster University, Hamilton, Ont.; Departments of Medicine (Ioannidis), Health Research and Policy (Ioannidis) and Biomedical Data Science (Ioannidis), and Statistics and Meta-Research Innovation Center at Stanford (METRICS) (Ioannidis), Stanford University, Stanford, Calif.; Biostatistics Unit (Thabane), St. Joseph's Healthcare, Hamilton, Ont.
Willi SauerbreiDepartments of Health Research Methods, Evidence, and Impact (Schandelmaier, Briel, Walsh, Thabane, Guyatt), Medicine (Walsh, Guyatt), Pediatrics (Thabane) and Anesthesia (Thabane), McMaster University, Hamilton, Ont.; Institute for Clinical Epidemiology and Biostatistics (Schandelmaier, Briel), Department of Clinical Research, Basel University, Basel, Switzerland; Division of Biostatistics and Bioinformatics (Varadhan), Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Md.; Department of Biostatistics (Schmid), Brown University School of Public Health, Brown University, Providence, RI; Indian institute of Public Health-Delhi (Devasenapathy), Public Health Foundation of India, New Delhi, India; VA Center for Clinical Management and Research (Hayward); Department of Internal Medicine (Hayward), University of Michigan School of Medicine; Department of Orthopaedic Surgery (Gagnier), University of Michigan; Department of Epidemiology (Gagnier), School of Public Health, University of Michigan, Ann Arbor, Mich.; Biostat (Borenstein), Englewood, NJ; Department of Social Dentistry (van der Heijden), Academic Center for Dentistry Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, Netherlands; Center for Evidence Synthesis in Health (Dahabreh) and Departments of Health Services, Policy, and Practice (Dahabreh) and Epidemiology (Dahabreh), School of Public Health, Brown University, Providence, RI; Chinese Evidence-Based Medicine Center (Sun), West China Hospital, Sichuan University, Chengdu, China; Institute of Medical Biometry and Statistics (Sauerbrei), Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany; Population Health Research Institute (Walsh), Hamilton Health Sciences/McMaster University, Hamilton, Ont.; Departments of Medicine (Ioannidis), Health Research and Policy (Ioannidis) and Biomedical Data Science (Ioannidis), and Statistics and Meta-Research Innovation Center at Stanford (METRICS) (Ioannidis), Stanford University, Stanford, Calif.; Biostatistics Unit (Thabane), St. Joseph's Healthcare, Hamilton, Ont.
Michael WalshDepartments of Health Research Methods, Evidence, and Impact (Schandelmaier, Briel, Walsh, Thabane, Guyatt), Medicine (Walsh, Guyatt), Pediatrics (Thabane) and Anesthesia (Thabane), McMaster University, Hamilton, Ont.; Institute for Clinical Epidemiology and Biostatistics (Schandelmaier, Briel), Department of Clinical Research, Basel University, Basel, Switzerland; Division of Biostatistics and Bioinformatics (Varadhan), Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Md.; Department of Biostatistics (Schmid), Brown University School of Public Health, Brown University, Providence, RI; Indian institute of Public Health-Delhi (Devasenapathy), Public Health Foundation of India, New Delhi, India; VA Center for Clinical Management and Research (Hayward); Department of Internal Medicine (Hayward), University of Michigan School of Medicine; Department of Orthopaedic Surgery (Gagnier), University of Michigan; Department of Epidemiology (Gagnier), School of Public Health, University of Michigan, Ann Arbor, Mich.; Biostat (Borenstein), Englewood, NJ; Department of Social Dentistry (van der Heijden), Academic Center for Dentistry Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, Netherlands; Center for Evidence Synthesis in Health (Dahabreh) and Departments of Health Services, Policy, and Practice (Dahabreh) and Epidemiology (Dahabreh), School of Public Health, Brown University, Providence, RI; Chinese Evidence-Based Medicine Center (Sun), West China Hospital, Sichuan University, Chengdu, China; Institute of Medical Biometry and Statistics (Sauerbrei), Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany; Population Health Research Institute (Walsh), Hamilton Health Sciences/McMaster University, Hamilton, Ont.; Departments of Medicine (Ioannidis), Health Research and Policy (Ioannidis) and Biomedical Data Science (Ioannidis), and Statistics and Meta-Research Innovation Center at Stanford (METRICS) (Ioannidis), Stanford University, Stanford, Calif.; Biostatistics Unit (Thabane), St. Joseph's Healthcare, Hamilton, Ont.
John P A IoannidisDepartments of Health Research Methods, Evidence, and Impact (Schandelmaier, Briel, Walsh, Thabane, Guyatt), Medicine (Walsh, Guyatt), Pediatrics (Thabane) and Anesthesia (Thabane), McMaster University, Hamilton, Ont.; Institute for Clinical Epidemiology and Biostatistics (Schandelmaier, Briel), Department of Clinical Research, Basel University, Basel, Switzerland; Division of Biostatistics and Bioinformatics (Varadhan), Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Md.; Department of Biostatistics (Schmid), Brown University School of Public Health, Brown University, Providence, RI; Indian institute of Public Health-Delhi (Devasenapathy), Public Health Foundation of India, New Delhi, India; VA Center for Clinical Management and Research (Hayward); Department of Internal Medicine (Hayward), University of Michigan School of Medicine; Department of Orthopaedic Surgery (Gagnier), University of Michigan; Department of Epidemiology (Gagnier), School of Public Health, University of Michigan, Ann Arbor, Mich.; Biostat (Borenstein), Englewood, NJ; Department of Social Dentistry (van der Heijden), Academic Center for Dentistry Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, Netherlands; Center for Evidence Synthesis in Health (Dahabreh) and Departments of Health Services, Policy, and Practice (Dahabreh) and Epidemiology (Dahabreh), School of Public Health, Brown University, Providence, RI; Chinese Evidence-Based Medicine Center (Sun), West China Hospital, Sichuan University, Chengdu, China; Institute of Medical Biometry and Statistics (Sauerbrei), Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany; Population Health Research Institute (Walsh), Hamilton Health Sciences/McMaster University, Hamilton, Ont.; Departments of Medicine (Ioannidis), Health Research and Policy (Ioannidis) and Biomedical Data Science (Ioannidis), and Statistics and Meta-Research Innovation Center at Stanford (METRICS) (Ioannidis), Stanford University, Stanford, Calif.; Biostatistics Unit (Thabane), St. Joseph's Healthcare, Hamilton, Ont.
Lehana ThabaneDepartments of Health Research Methods, Evidence, and Impact (Schandelmaier, Briel, Walsh, Thabane, Guyatt), Medicine (Walsh, Guyatt), Pediatrics (Thabane) and Anesthesia (Thabane), McMaster University, Hamilton, Ont.; Institute for Clinical Epidemiology and Biostatistics (Schandelmaier, Briel), Department of Clinical Research, Basel University, Basel, Switzerland; Division of Biostatistics and Bioinformatics (Varadhan), Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Md.; Department of Biostatistics (Schmid), Brown University School of Public Health, Brown University, Providence, RI; Indian institute of Public Health-Delhi (Devasenapathy), Public Health Foundation of India, New Delhi, India; VA Center for Clinical Management and Research (Hayward); Department of Internal Medicine (Hayward), University of Michigan School of Medicine; Department of Orthopaedic Surgery (Gagnier), University of Michigan; Department of Epidemiology (Gagnier), School of Public Health, University of Michigan, Ann Arbor, Mich.; Biostat (Borenstein), Englewood, NJ; Department of Social Dentistry (van der Heijden), Academic Center for Dentistry Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, Netherlands; Center for Evidence Synthesis in Health (Dahabreh) and Departments of Health Services, Policy, and Practice (Dahabreh) and Epidemiology (Dahabreh), School of Public Health, Brown University, Providence, RI; Chinese Evidence-Based Medicine Center (Sun), West China Hospital, Sichuan University, Chengdu, China; Institute of Medical Biometry and Statistics (Sauerbrei), Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany; Population Health Research Institute (Walsh), Hamilton Health Sciences/McMaster University, Hamilton, Ont.; Departments of Medicine (Ioannidis), Health Research and Policy (Ioannidis) and Biomedical Data Science (Ioannidis), and Statistics and Meta-Research Innovation Center at Stanford (METRICS) (Ioannidis), Stanford University, Stanford, Calif.; Biostatistics Unit (Thabane), St. Joseph's Healthcare, Hamilton, Ont.
Gordon H GuyattDepartments of Health Research Methods, Evidence, and Impact (Schandelmaier, Briel, Walsh, Thabane, Guyatt), Medicine (Walsh, Guyatt), Pediatrics (Thabane) and Anesthesia (Thabane), McMaster University, Hamilton, Ont.; Institute for Clinical Epidemiology and Biostatistics (Schandelmaier, Briel), Department of Clinical Research, Basel University, Basel, Switzerland; Division of Biostatistics and Bioinformatics (Varadhan), Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Md.; Department of Biostatistics (Schmid), Brown University School of Public Health, Brown University, Providence, RI; Indian institute of Public Health-Delhi (Devasenapathy), Public Health Foundation of India, New Delhi, India; VA Center for Clinical Management and Research (Hayward); Department of Internal Medicine (Hayward), University of Michigan School of Medicine; Department of Orthopaedic Surgery (Gagnier), University of Michigan; Department of Epidemiology (Gagnier), School of Public Health, University of Michigan, Ann Arbor, Mich.; Biostat (Borenstein), Englewood, NJ; Department of Social Dentistry (van der Heijden), Academic Center for Dentistry Amsterdam, University of Amsterdam and VU University Amsterdam, Amsterdam, Netherlands; Center for Evidence Synthesis in Health (Dahabreh) and Departments of Health Services, Policy, and Practice (Dahabreh) and Epidemiology (Dahabreh), School of Public Health, Brown University, Providence, RI; Chinese Evidence-Based Medicine Center (Sun), West China Hospital, Sichuan University, Chengdu, China; Institute of Medical Biometry and Statistics (Sauerbrei), Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany; Population Health Research Institute (Walsh), Hamilton Health Sciences/McMaster University, Hamilton, Ont.; Departments of Medicine (Ioannidis), Health Research and Policy (Ioannidis) and Biomedical Data Science (Ioannidis), and Statistics and Meta-Research Innovation Center at Stanford (METRICS) (Ioannidis), Stanford University, Stanford, Calif.; Biostatistics Unit (Thabane), St. Joseph's Healthcare, Hamilton, Ont.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMost randomized controlled trials (RCTs) and meta-analyses of RCTs examine effect modification (also called a subgroup effect or interaction), in which the effect of an intervention varies by another variable (e.g., age or disease severity). Assessing the credibility of an apparent effect modification presents challenges; therefore, we developed the Instrument for assessing the Credibility of Effect Modification Analyses (ICEMAN).

methodsTo develop ICEMAN, we established a detailed concept; identified candidate credibility considerations in a systematic survey of the literature; together with experts, performed a consensus study to identify key considerations and develop them into instrument items; and refined the instrument based on feedback from trial investigators, systematic review authors and journal editors, who applied drafts of ICEMAN to published claims of effect modification.

resultsThe final instrument consists of a set of preliminary considerations, core questions (5 for RCTs, 8 for meta-analyses) with 4 response options, 1 optional item for additional considerations and a rating of credibility on a visual analogue scale ranging from very low to high. An accompanying manual provides rationales, detailed instructions and examples from the literature. Seventeen potential users tested ICEMAN; their suggestions improved the user-friendliness of the instrument.

interpretationThe Instrument for assessing the Credibility of Effect Modification Analyses offers explicit guidance for investigators, systematic reviewers, journal editors and others considering making a claim of effect modification or interpreting a claim made by others.

Indexed as

Meta-Analysis as TopicRandomized Controlled Trials as TopicConsensusHumansResearch Design

Identifiers

PMID32778601
PMCPMC7829020

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.