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Innovations in Reasoning About
Health: The Case of the
Randomized Clinical Trial
Jodi Schneider, Sally Jackson
University ...
Source for argument: Bada et al. (2015). Morphine versus clonidine for neonatal abstinence syndrome.
Claim: Clonidine may ...
Claim: Clonidine may be a
favorable alternative to
morphine as a single-drug
therapy for NAS.
Data: Infants with NAS given...
“Innovations” in reasoning and arguing
Our research project focuses on fields where innovation is occurring
rapidly (e.g.,...
Warrants
• Warrants are inference rules governing how conclusions are drawn, not
statements from which conclusions are dra...
Warrants
• Warrants are inference rules governing how conclusions are drawn, not
statements from which conclusions are dra...
Data Claim
Warranting rule
Dependable because
backed by:
Material
assurances
Procedural
assurances
Institutional
assurance...
Warranting Devices - Definition
(1) an inference license in Toulmin’s sense
(2) invented for a specialized argumentative p...
Claim: Clonidine may be a
favorable alternative to
morphine as a single-drug
therapy for NAS.
Data: Infants with NAS given...
patients & providers
recruited
Treatment B
Treatment A measurements
measurements
random allocation
blinding, other control...
simple randomized clinical trial
patients & providers
recruited
Treatment B
Treatment A measurements
measurements
random a...
Blinding
(1784)
Random
allocation
(1883)
Outcome
measures
(1914)
Statistical
significance
testing
(1925)
Placebos
(1930)
I...
Published
RCTs
(by 1944)
Institutional
Review
(1966 in US)
Registration
of Trials
(2004)
The RCT continues to evolve
Bradford Hill’s “The Clinical Trial”, 1952
Conclusion: Use CCTs to form beliefs
about medical treatments. [P27]
Goal: advancement of
knowledge on which good
treatmen...
Circumstances: problems in prevailing methods
for forming beliefs about treatment
Means-End: CCTs correct weaknesses in
in...
Black boxing
• Warranting devices, once established within a field, may be employed
without further defense across many si...
“Beyond RCT”
• Although RCT remains the gold standard for causal reasoning today,
new competitors can arise at any time.
A Summary of Our Argument
• Real argumentation serves practical purposes.
• Innovation in reasoning and arguing is driven ...
patients & providers
recruited
Treatment B
Treatment A measurements
measurements
random allocation
measurements
measuremen...
Conclusion: Apply rule R
for belief formation in
domain D.
Goal: To form correct
beliefs in domain D.
Circumstances: Vario...
Innovations in reasoning about health: the case of the Randomized Clinical Trial--ISSA 2018-07-05
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Innovations in reasoning about health: the case of the Randomized Clinical Trial--ISSA 2018-07-05

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Presentation: Jodi Schneider and Sally Jackson, “Innovations in Reasoning About Health: The Case of the Randomized Clinical Trial.” 9th International Conference on Argumentation, International Society for the Society of Argumentation, Amsterdam, Netherlands, July 5, 2018

Abstract: Field-dependence in argumentation comes about through forms of inference invented by specialized fields. In recent work we introduced the concept of a "warranting device": (1) an inference license (2) invented for a specialized argumentative purpose and (3) backed by institutional, procedural, and material assurances of the dependability of conclusions generated by the device. Once established, fields employ such devices across many situations without further defense, even as the devices develop in response to newly-noticed problems.

Many new warranting devices have appeared over the past century to solve problems in reasoning about health and medicine, replacing and obsolescing earlier forms of medical reasoning. One such device is the Randomized Controlled Trial. This case study traces its historical evolution and discusses some current movements toward competing device types.

Publié dans : Santé & Médecine
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Innovations in reasoning about health: the case of the Randomized Clinical Trial--ISSA 2018-07-05

  1. 1. Innovations in Reasoning About Health: The Case of the Randomized Clinical Trial Jodi Schneider, Sally Jackson University of Illinois at Urbana-Champaign United States of America ISSA, Amsterdam, 2018-07-05
  2. 2. Source for argument: Bada et al. (2015). Morphine versus clonidine for neonatal abstinence syndrome. Claim: Clonidine may be a favorable alternative to morphine as a single-drug therapy for NAS. Data: Infants with NAS given clonidine improved more rapidly than those given morphine and had equal outcomes on other measures.
  3. 3. Claim: Clonidine may be a favorable alternative to morphine as a single-drug therapy for NAS. Data: Infants with NAS given clonidine improved more rapidly than those given morphine and had equal outcomes on other measures. Source for argument: Bada et al. (2015). Morphine versus clonidine for neonatal abstinence syndrome. Warrant: Randomized Clinical Trial
  4. 4. “Innovations” in reasoning and arguing Our research project focuses on fields where innovation is occurring rapidly (e.g., health): • Search for novel ways of drawing and defending conclusions (new warrants) • Examination of how these novel warrants are established (and sometimes dis-established) within fields
  5. 5. Warrants • Warrants are inference rules governing how conclusions are drawn, not statements from which conclusions are drawn. • “The claim is not presented as following from the warrant; rather it is presented as following from the grounds in accordance with the warrant.” (Hitchcock 2003, p. 71) • Warrants do not typically appear in the argument. • “Arguments instance inference rules, rather than include them as elements…” (Freeman 2011, p. 88; Hitchcock 2003 agrees) • Warrants generate conclusions as well as justify them • In law, relevant statute allows for “findings” of guilt or innocence (Toulmin, 1958, p. 99) • In science, “standard equations” generate predictions (Toulmin, 1958, p. 121) • They can be technical in multiple senses: • Expert communities devise them as tools for conclusion-drawing • They depend on “built” things (Jackson & Schneider 2018)
  6. 6. Warrants • Warrants are inference rules governing how conclusions are drawn, not statements from which conclusions are drawn. • “The claim is not presented as following from the warrant; rather it is presented as following from the grounds in accordance with the warrant.” (Hitchcock 2003, p. 71) • Warrants do not typically appear in the argument. • “Arguments instance inference rules, rather than include them as elements…” (Freeman 2011, p. 88; Hitchcock 2003 agrees) • Warrants generate conclusions as well as justify them • In law, relevant statute allows for “findings” of guilt or innocence (Toulmin, 1958, p. 99) • In science, ”standard equations” generate predictions (Toulmin, 1958, p. 121) • They can be technical in multiple senses: • Expert communities devise them as tools for conclusion-drawing • They depend on “built” things (Jackson & Schneider 2018)
  7. 7. Data Claim Warranting rule Dependable because backed by: Material assurances Procedural assurances Institutional assurances Source of figure: Jackson & Schneider 2018. Cochrane Review as a "Warranting Device" for Reasoning About Health. Warranting Devices
  8. 8. Warranting Devices - Definition (1) an inference license in Toulmin’s sense (2) invented for a specialized argumentative purpose and (3) backed by institutional, procedural, and material components that provide assurances of the dependability of conclusions generated by the device Source: Jackson & Schneider 2018. Cochrane Review as a "Warranting Device" for Reasoning About Health.
  9. 9. Claim: Clonidine may be a favorable alternative to morphine as a single-drug therapy for NAS. Data: Infants with NAS given clonidine improved more rapidly than those given morphine and had equal outcomes on other measures. Source for argument: Bada et al. (2015). Morphine versus clonidine for neonatal abstinence syndrome. Warrant: Randomized Clinical Trial material resources procedures institutions
  10. 10. patients & providers recruited Treatment B Treatment A measurements measurements random allocation blinding, other controls monitoring simple randomized clinical trial which group did better? statistical comparison
  11. 11. simple randomized clinical trial patients & providers recruited Treatment B Treatment A measurements measurements random allocation blinding, other controls monitoring which group did better? statistical comparison protocol approved
  12. 12. Blinding (1784) Random allocation (1883) Outcome measures (1914) Statistical significance testing (1925) Placebos (1930) Inventions contributing to the RCT
  13. 13. Published RCTs (by 1944) Institutional Review (1966 in US) Registration of Trials (2004) The RCT continues to evolve
  14. 14. Bradford Hill’s “The Clinical Trial”, 1952
  15. 15. Conclusion: Use CCTs to form beliefs about medical treatments. [P27] Goal: advancement of knowledge on which good treatment of patients depends at population level [P27] Circumstances: problems in prevailing methods for forming beliefs about treatment • variability in patient response to treatment [P6,7,9] • inability to distinguish between small effects and absent effects [P25] • inability to identify cause [P9,22] • inability to generalize [P9,10] • bias in individual clinician judgment [P13,22] and in patient judgment [P22] • a ‘literature’ composed of conflicting true findings [P6] Values: medical ethics (primacy of patient welfare) [P3], expertise [P1] Means-End: CCTs correct weaknesses in individual clinical judgments • successful in Great Britain [P21,22,25] and spreading [P14] • trial design eliminates various problems • random allocation of patients [P13] • blinding [P21] • exact specification of treatment schedule [P17,18] • standardized measurement [P19] • independent assessors [P21,23] Reconstruction of Bradford Hill’s Warrant-Establishing Argument, adapted from the practical argument scheme presented in I. Fairclough 2016: A Dialectical Profile for the Evaluation of Practical Arguments.
  16. 16. Circumstances: problems in prevailing methods for forming beliefs about treatment Means-End: CCTs correct weaknesses in individual clinical judgments Conclusion: Use CCTs to form beliefs about medical treatments. [P27] Imputed counterclaim: Reject CCTs [P2] Goal: advancement of knowledge on which good treatment of patients depends at population level Because the rationale for the action is faulty: • primary goal must be best care for the individual patient [P3] • don’t need CCTs to know what works [P24,25] • statisticians lack medical knowledge, count the wrong things, care only about the group [P1,3,4] • measures can’t replace clinical judgment [P5] • humans too variable to allow CCTs to generate medical wisdom [P6] Because the action itself is: • impractical (large numbers [P7-11], co- ordination [P18]) • unethical to experiment on patients [P26] • disregard of primary clinical responsibility • set treatment schedule not best [P17,18] • wrong to reduce patients to numbers • challenges authority of clinician [P1] Adapted from the deliberation scheme presented in I. Fairclough 2016: A Dialectical Profile for the Evaluation of Practical Arguments.
  17. 17. Black boxing • Warranting devices, once established within a field, may be employed without further defense across many situations. • Their initial establishment within a domain may be followed by an open-ended process of reconfiguration in response to newly-noticed problems. • “Black box arguments are a constantly evolving technology for coming to conclusions and making these conclusions broadly acceptable.” (Jackson, 2008)
  18. 18. “Beyond RCT” • Although RCT remains the gold standard for causal reasoning today, new competitors can arise at any time.
  19. 19. A Summary of Our Argument • Real argumentation serves practical purposes. • Innovation in reasoning and arguing is driven by these practical purposes. • New inference rules have to be argued into existence; they can be argued out just as well. • Change in the stock of usable warrants is normal. New things are invented and old things are abandoned.
  20. 20. patients & providers recruited Treatment B Treatment A measurements measurements random allocation measurements measurements blinding, other controls monitoring protocol approved randomized clinical trial with pretest and posttest measurements did Group A improve? did Group B improve? which group did better?
  21. 21. Conclusion: Apply rule R for belief formation in domain D. Goal: To form correct beliefs in domain D. Circumstances: Various ways incorrect beliefs may form in domain D. Values: Professional ethics in domain D, reason domain D is studied, etc. Means-End: Reasons for believing that rule R generates correct beliefs and/or avoids incorrect beliefs.

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