Health Outcome of Interest Validations and Literature Reviews

This webpage provides access to Sentinel Health Outcome of Interest (HOI) activities that have been conducted by the FDA. The search options below can be used to find more information about each study type or health outcome. Code lists (such as ICD-9-CM codes, ICD-10 codes, procedure codes, etc.), algorithm criteria, and literature reviews for these activities appear in the form of reports or Microsoft Excel workbooks. These materials can be found by clicking on either the hyperlinked Deliverables listed or the hyperlinked Title to navigate to the activity’s webpage which also lists the Deliverables.

  • Novel Approaches to More Efficient Outcome Validation aim to identify solutions to the governance, process, and technology barriers to support more efficient outcome validation as a starting point for greater sufficiency of Active Risk Identification and Analysis (ARIA), a stronger Sentinel System, and a more rigorous evidence generation enterprise.
  • Validations Supported by Traditional Medical Chart Review involve checking codes derived from electronic medical records and administrative claims-based data against medical chart information to verify that the electronic codes validly and reliably identify individuals with particular medical conditions.
  • Outcomes Assessed in Inferential Analyses identify medical conditions defined as outcomes of interest in inferential analyses and their respective code lists and algorithm criteria.
  • Coding Trend Analyses display the trends for outcome definitions across the ICD-9-CM and ICD-10-CM/PCS eras.
  • Literature Reviews primarily concern identification of health outcomes and focus on determining which codes in electronic medical record and administrative claims-based data are the most valid and reliable indicators of the presence of particular medical conditions.

Literature Reviews

Title Outcomes Reports Status Date Posted
HOI Literature Review - Venous Thromboembolism venous thromboembolism (VTE) Complete 09/04/2011
HOI Literature Review - Gap Analysis angioedema, venous thromboembolism (VTE), anaphylaxis, anaphylactic shock, Achilles tendon rupture (ATR), cerebrovascular accident (CVA), transient ischemic attack (TIA), congestive heart failure, atrial fibrillation, depression, suicide, epilepsy, pancreatitis, lymphoma, toxic epidermal necrolysis, pulmonary fibrosis, interstitial lung disease, acute respiratory failure, orthopedic implant removal and revision, attempted suicide, serious cardiac arrhythmia, transfusion-related ABO incompatibility reaction, seizure, convulsion, transfusion-related septicemia, erythema multiforme major, hypersensitivity reaction, infection related to blood products, tissue grafts, or organ transplantation Complete 08/18/2011
HOI Literature Review - Hypersensitivity Reactions hypersensitivity reaction, fever Complete 07/29/2011
HOI Literature Review - Orthopedic Implant Removal orthopedic implant removal and revision Complete 07/19/2011
HOI Literature Review - Pulmonary Fibrosis pulmonary fibrosis, interstitial lung disease Complete 07/14/2011
HOI Literature Review - Atrial Fibrillation atrial fibrillation Complete 06/30/2011
HOI Literature Review - Erythema Multiforme erythema multiforme minor, Stevens–Johnson Syndrome, toxic epidermal necrolysis, erythema multiforme major Complete 06/16/2011
HOI Literature Review - Transfusion Sepsis transfusion-related septicemia, transfusion-related sepsis Complete 06/15/2011
HOI Literature Review - Respiratory Failure acute respiratory failure Complete 06/13/2011
HOI Literature Review - Anaphylaxis anaphylaxis, angioneurotic edema, anaphylactic shock Complete 06/10/2011
HOI Literature Review - Seizures seizure, convulsion, epilepsy Complete 06/06/2011
HOI Literature Review - CVA/TIA transient ischemic attack (TIA), cerebrovascular accident (CVA) Complete 06/02/2011
HOI Literature Review - Lymphomas lymphoma Complete 05/27/2011
HOI Literature Review - ABO Incompatibility transfusion-related ABO incompatibility reaction Complete 05/27/2011
HOI Literature Review- Transfusion/Graft Infections infection related to tissue graft, infection related to blood product, tissue graft Complete 05/27/2011
HOI Literature Review - Pancreatitis pancreatitis Complete 05/20/2011
HOI Literature Review - Cardiac Arrhythmias serious cardiac arrhythmia, including ventricular fibrillation, supraventricular tachycardia (SVT), torsades de pointes, cardiac arrest, sudden cardiac death Complete 03/02/2011
HOI Literature Review - Depression depression Complete 02/08/2011
HOI Literature Review - Congestive Heart Failure congestive heart failure Complete 02/08/2011
HOI Literature Review - Suicide suicide, suicidal ideation, attempted suicide Complete 02/07/2011