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.
     

Validations Supported by Traditional Medical Chart Review

Title Outcomes Reports Status Date Posted
Validation of Stillbirth in ICD-10-CM stillbirth In progress 07/17/2018
Influenza Vaccines and Birth Outcomes Cleft lip without cleft palate, cleft palate without cleft lip, or cleft lip with cleft palate Complete 03/28/2018
Validation of Hodgkin’s and Non-Hodgkin’s Lymphoma in ICD-10 CM Hodgkin's lymphoma, non-Hodgkin's lymphoma In progress 02/22/2018
Influenza Vaccines and Pregnancy Outcomes (PRISM) Spontaneous abortion (SAB) Complete 01/26/2018
Validation of Serious Infections among an Immunocompromised Population serious infection In progress 11/19/2017
Thromboembolic Events After Immunoglobulin Administration thromboembolic events (TEE), ischemic stroke, venous thromboembolism (VTE), acute myocardial infarction Complete 07/13/2017
Gardasil Vaccination and Venous Thromboembolism (PRISM) venous thromboembolism (VTE) Complete 04/21/2015
Intussusception Risk After Rotavirus Vaccination in U.S. Infants (PRISM) Intussusception Complete 02/03/2014
Validation of Acute Kidney Injury Cases Acute kidney injury Complete 12/22/2013
Validation of Anaphylaxis Cases anaphylaxis Complete 03/27/2013
Validation of Severe Liver Injury Cases severe liver injury Complete 01/29/2013
Validation of Acute Myocardial Infarction Cases AMI, acute myocardial infarction Complete 07/01/2011

Outcomes Assessed in Inferential Analyses

Title Outcomes Reports Status Date Posted
Gastrointestinal Bleeding Algorithm Defined in "Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Gastrointestinal (GI) Bleeding Following New Use of Warfarin Compared with Statins" gastrointestinal bleeding Complete 06/25/2018
Gastrointestinal Bleed Algorithm Defined in "PROMPT: Rivaroxaban Surveillance, Gastrointestinal Bleed" gastrointestinal bleeding Complete 05/10/2018
Intracranial Hemorrhage Algorithm Defined in "PROMPT: Rivaroxaban Surveillance, Intracranial Hemorrhage" intracranial hemorrhage Complete 05/07/2018
Intussusception Algorithm Defined in "Intussusception Risk After Rotavirus Vaccination in U.S. Infants (PRISM)" Intussusception Complete 05/07/2018
Clostridium difficile Algorithm Defined in "Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Clostridium difficile Events After Use of Oral Clindamycin versus Penicillins" clostridium difficile Complete 04/30/2018
Complex Regional Pain Syndrome (CRPS), Uveitis, Acute Disseminated Encephalomyelitis (ADEM), and Acute Pericarditis Algorithms Defined in "Sequential Analysis of Gardasil 9 Safety" complex regional pain syndrome (CRPS), acute disseminated encephalomyelitis (ADEM), acute pericarditis, uveitis Complete 04/30/2018
Hypoglycemia Algorithm Defined in "Testing Routine Querying Tools with Known Positive Exposure-Outcome Associations: Hypoglycemia Events After Use of Glyburide versus Glipizide" Hypoglycemia Complete 04/26/2018
Seizure Algorithm Defined in "Ranexa (Ranolazine) and Seizures" seizure Complete 04/24/2018
Stroke Algorithm Defined in "Antipsychotics/Selective Serotonin Reuptake Inhibitors (SSRIs) and Stroke" stroke, ischemic stroke, hemorrhagic stroke Complete 04/23/2018
Stroke Algorithm Defined in "Antipsychotics and Stroke" stroke, ischemic stroke, hemorrhagic stroke Complete 04/23/2018
Venous Thromboembolism Algorithm Defined in "Venous Thromboembolism after Continuous or Extended Cycle Contraceptive Use" venous thromboembolism (VTE) Complete 04/23/2018

Coding Trend Analyses

Title Outcomes Reports Status Date Posted
Coding Trend Analyses: Rhabdomyolysis rhabdomyolysis Complete 06/15/2018
Coding Trend Analyses: Myocarditis myocarditis Complete 06/15/2018
Coding Trend Analyses: Myositis myositis Complete 06/15/2018

Literature Reviews

Title Outcomes Reports Status Date Posted
Health Outcome Algorithm Inventory Achilles tendon rupture (ATR), acute respiratory failure, agranulocytosis, Bell’s palsy, erythema multiforme major (including Stevens-Johnson syndrome and toxic epidermal necrolysis), febrile seizures, gastrointestinal bleeding, Guillain-Barré syndrome, Henoch Schönlein purpura (HSP), hip fracture, idiopathic thrombocytopenic purpura, juvenile rheumatoid arthritis, peripheral neuropathy, pulmonary fibrosis, pulmonary hypertension, rhabdomyolysis, Severe acute liver injury, stillbirth, Spontaneous abortion (SAB), sudden cardiac death, suicide (including attempted suicide), systemic lupus erythematosus (SLE), thrombocytopenia, tuberculosis (TB), type I diabetes, venous thromboembolism (VTE), acute intracranial hemorrhage, acute ischemic stroke, acute pancreatitis, acute stroke (ischemic or hemorrhagic), aplastic anemia, asthma exacerbation, hypertensive emergency, inflammatory bowel disease (IBD), neutropenia, premature delivery, sepsis, sudden or rapidly-progressing hearing loss, thrombotic thrombocytopenic purpura Complete 05/23/2016
16 Health Outcomes of Interest for Surveillance Preparedness Achilles tendon rupture, erythema multiforme major (including Stevens-Johnson syndrome and toxic epidermal necrolysis), Guillain-Barré syndrome, hip fracture, idiopathic thrombocytopenic purpura, peripheral neuropathy, pulmonary hypertension, rhabdomyolysis, Severe acute liver injury, sudden cardiac death and ventricular arrhythmia, suicide (including attempted suicide), thrombocytopenia, type I diabetes, valvulopathy, febrile seizures, Henoch Schönlein purpura (HSP) Complete 07/01/2014
HOI Evidence Reviews (PRISM) Bell’s palsy, acute bronchospasm, Kawasaki disease, myopericarditis, rheumatoid arthritis, systemic lupus erythematosus (SLE), stillbirth, spontaneous abortion, transverse myelitis, uveitis, idiopathic facial palsy, wheeze, acute asthma, acute disseminated encephalomyelitis (ADEM), optic neuritis, tics, Henoch Schönlein purpura (HSP), myocarditis, bronchospasm, intrauterine fetal demise Complete 12/25/2013
HOI Literature Review - Venous Thromboembolism venous thromboembolism (VTE) Complete 09/05/2011
HOI Literature Review - Gap Analysis cerebrovascular accident (CVA), transient ischemic attack (TIA), congestive heart failure, atrial fibrillation, serious cardiac arrhythmias, venous thromboembolism (VTE), depression, suicide (including attempted suicide), seizure, convulsion, epilepsy, pancreatitis, lymphoma, transfusion-related septicemia and sepsis, transfusion-related ABO incompatibility reaction, Achilles tendon rupture (ATR), erythema multiforme major (including Stevens-Johnson syndrome and toxic epidermal necrolysis), anaphylaxis, Anaphylactic shock, Angioedema, hypersensitivity reactions other than anaphylaxis, pulmonary fibrosis, interstitial lung disease, acute respiratory failure, orthopedic implant removal and revision, infection related to blood products, tissue grafts, or organ transplantation Complete 08/18/2011
HOI Literature Review - Hypersensitivity Reactions hypersensitivity reactions other than anaphylaxis, fever, rash, lymphadenopathy Complete 07/29/2011
HOI Literature Review - Orthopedic Implant Removal removal (explantation) or revision of orthopedic device, removal of implanted device, orthopedic device, implanted device, 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 Stevens–Johnson Syndrome, erythema multiforme major/minor/not otherwise specified, toxic epidermal necrolysis Complete 06/16/2011
HOI Literature Review - Transfusion Sepsis transfusion-related septicemia and sepsis, 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- Transfusion/Graft Infections infection associated with blood products or tissue grafts, infection related to blood products, tissue grafts Complete 05/27/2011
HOI Literature Review - ABO Incompatibility transfusion-related ABO incompatibility reaction Complete 05/27/2011
HOI Literature Review - Lymphomas lymphoma Complete 05/27/2011
HOI Literature Review - Pancreatitis pancreatitis Complete 05/20/2011
HOI Literature Review - Cardiac Arrhythmias serious cardiac arrhythmias, including ventricular fibrillation, supraventricular tachycardia (SVT), torsades de pointes, cardiac arrest, sudden cardiac death Complete 03/02/2011
HOI Literature Review - Suicide suicide, suicidal ideation, suicide (including attempted suicide) Complete 02/08/2011
HOI Literature Review - Depression depression Complete 02/08/2011
HOI Literature Review - Congestive Heart Failure congestive heart failure Complete 02/08/2011