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Please provide an alternative term or definition, the relevant reference(s) to the sources and your rationale for including the alternative term or definition instead of that provided for Mitigating

Factors.

II 1. Differentiate mitigating factors in (a) "early intervention" (arrow between "risky healthcare acts" and patient outcome) (b)and "impact alleviating factors" (arrow between patient outcome and patient impact. For organizational impact: use "reorganization", "organizational amendment" or else Comment: The conceptual framework has been reviewed and refined. See Introduction, Basic Definitions and New Framework – (a) mitigating (b) ameliorating.

II 2. '...in diminishing the impact of an event on the safety of patient.' Comment: The revised definition incorporates these comments.

II 3. A circumstance, action or influence that played a role in diminishing patient harm or in providing compensation for patient harm.

Comment: The revised definition incorporates these comments.

II 4. Impact diminishing factor

II 5. What tense are you taking about? recovery Factors does not make sense but Factors affecting recovery does? Or are you talking about Significant Clinical Feature (e.g history of MI)

Comment: The definition has been revised.

II 6. An effort or action taken or in place and designed to reduce the patient harm or organizational impact that could result from a patient safety event.

Comment: The definition has been revised.

II 7. Mitigating may be acceptable if the term recovery is sufficiently altered to distinguish the categories.

Comment: The term and definition have been revised.

II 8. I would not use the word "diminishing". I would change it to decreasing or increasing the level of the outcome. PS - your * description is incorrect

Comment: The term and definition have been revised.

II 9. ?

Page 111 of 194 II 10. again I think you mean Mitigating Factor, and I think the term is fine, just need to amend your

definition of....see above

II 11. ... I think mitigating factors should point to the outcomes

II 12. These categories would be clumsy to use and should be amalgamated with each other and perhaps also with Actions taken.

Comment: The conceptual framework and concepts have been revised to alleviate confusion.

II 13. A circumstance, action or influence previously defined that played a role in diminishing the impact of a patient safety event.

Comment: The revised definition incorporates these comments.

II 14. If the broader notion were to be attempted, a new name would be needed.

II 15. Safety factors would mean that something has been introduced to play a role in diminishing the impact of a patient safety event.

Comment: The revised definition incorporates these comments.

II 16. None

II 17. An action taken or condition in place that played a role in diminishing the impact of a patient safety event.

Comment: The revised definition incorporates these comments.

II 18. are they preexisting? have they previously been put in place again as with recover unsure of timing here within framework....

II 19. controls

II 20. Diminishing factors might explain this better.

II 21. XX

II 22. See previous box.

II 23. Modifying my earlier suggestion, I would suggest now that the three categories in that part of the structure be denominated, within the box of each, "event preventive factors," "event recovery factors"

and "patient safety event mitigating factors."

Comment: The conceptual framework and concepts have been revised to incorporate these comments.

II 24. As before II 25. example include

II 26. The whole column, "Recover Factors", needs reworking.

Comment: Agreed, the class has been reviewed, refined, and revised.

II 27. Mitigating Factors – A circumstance, action or influence that played a role in diminishing the impact of a patient safety event to the patient.

Comment: The revised definition incorporates these comments.

II 28. event modifiers

II 29. see my previous comments II 30. see previous

II 31. No suggestion

II 32. Diminishing effects factors

Page 112 of 194

Comments from the Question – Do you believe this is a meaningful and useful class?

III

III 1. see previous answer

III 2. Already gave this reason. This is not a clinical term but I am sure a term already exists for what you mean III 3. As previously discussed in the CPSI response, the information is likely meaningful however the distinction

between this class and recovery factors is subtle and likely to produce unreliable data.

III 4. How specifically is this different than preventive and recovery factors. Seems like sometimes we spend too much time slotting things into the right descriptive bucket instead of just identifying it. The more possibilities you have the more folks become obsessed with the minutia instead of focusing on the real factors which contributed to the event.

Comment: The conceptual framework and concepts have been revised for clarity and simplicity.

III 5. see previous answer

III 6. Again, important but should be oriented differently in diagram. See earlier comments

III 7. Mitigating Factors should be consolidated with Recovery Factors. Both would benefit from substantial revision for the mix of reasons referred to in relation to Chapter VII.

Comment: The conceptual framework and concepts have been revised in line with these and other concepts.

III 8. confusing term

III 9. see previous comment re the need to expand the concept.

III 10. Mitigating can mean "making an offence or a crime seem less serious, or partly excusing it"

III 11. I understand the term but would everyone else? It is more of a litigation term.

Comment: The term and definition have been revised.

III 12. Same

III 13. As described in the examples, I would see such concepts as more appropriately described as recovery factors.

Comment: The concepts have been reviewed and reorganized where appropriate.

III 14. See previous statement.

III 15. controls is a better term III 16. please see previous answer III 17. See previous comment

III 18. Emphasize tertiary prevention aspect, and bring out organizational and systemic factors as well as specifically clinical aspects that made this possible.

Comment: The concepts in this class have been reviewed. Additional concepts have been incorporated; others have been revised.

III 19. There are muddy boundaries among "preventive," "recovery," and "mitigating" factors.

III 20. As with contributing factors

III 21. it is not clear to me what the difference is between these and recovery factors

Comment: The conceptual framework has been revised to clarify the distinguishing characteristics of each class and to illustrate the relationship between and among them.

Page 113 of 194 III 22. distinction between recover and mitigating is difficult in a real-world application

Comment: The conceptual framework and concepts have been revised to clarify the distinction between the classes. “Real world” applicability will be tested in the field.

III 23. mitigation can be mixed in with prevention and recovery III 24. See my previous comments on the need to include macro level III 25. see my comments

III 26. If there are mitigating factors why not enhancing factors III 27. As with recovery factors

III 28. without a standardized approach such a question has little help of securing consistent reliable information Comment: Agreed, business rules will be developed to create a standardized approach. This approach will be tested for real world applicability and revised accordingly based on the results.

Additional Comments from e-mails None

Delphi Task Force Comments

Feedback from Round 1 indicated confusion about the definition and role of the Mitigating Factors class, as well