List of Triggers (IHI Trigger tool).pptx
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The document discusses the IHI Global Trigger Tool, which is used to identify adverse events in inpatient populations by focusing on harm or injury from the patient's perspective. It defines harm as an unintended physical injury from or contributed to by medical care that requires additional monitoring, treatment or hospitalization, or results in death. The tool includes adverse events related to active delivery of care but excludes events related to substandard care. It then lists the various trigger modules used in the tool, including care, emergency, medication, intensive care, perinatal care, and surgical care modules. Each module lists specific triggers or events that would indicate an adverse event occurred.
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Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
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- 1. 1 IHI’s Global Trigger Tool
- 2. IHI Global Trigger Tool • Identify Adverse Events in inpatient populations and focuses on identification of harm or injury especially from patient’s perspective • Definition for HARM as per IHI’s GTT: unintended physical injury resulting from or contributed to by medical care that requires additional monitoring, treatment or hospitalization, or that results in death • Includes AE’s related to active delivery of care (Commission) Excludes AE’s related to substandard care (Omission)
- 3. Trigger Modules • Care module (15) • Emergency module (02) • Medication module (13) • Intensive care module (04) • Perinatal care module (08) • Surgical care module (11)
- 4. Care Module C1: Transfusion or use of blood products C2: Code/arrest/rapid response team C3: Acute dialysis C4: Positive blood culture C5: X-ray or Doppler studies for emboli or DVT C6: Decrease of greater than 25% in hemoglobin or hematocrit C7: Patient fall C8: Pressure ulcers C9: Readmission within 30 days C10: Restraint use C11: Healthcare-associated infection C12: In-hospital stroke C13: Transfer to higher level of care C14: Any procedure complication C15: Other
- 5. Emergency module E1: Readmission to ED within 48 hours E2: Time in ED greater than 6 hours
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- 7. Intensive Care module I1: Pneumonia onset I2: Readmission to intensive care I3: In-unit procedure I4: Intubation/reintubation
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- 9. Surgery care module S1: Return to surgery S2: Change in procedure S3: Admission to intensive care post-op S4: Intubation/reintubation/BiPap in Post Anesthesia Care Unit (PACU) S5: X-ray intra-op or in PACU S6: Intra-op or post-op death S7: Mechanical ventilation greater than24 hours post-op S8: Intra-op epinephrine, norepinephrine, naloxone, or romazicon S9: Post-op troponin level greater than1.5 ng/ml S10: Injury, repair, or removal of organ S11: Any operative complication