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
Validation of Lymphoma in ICD-10-CM lymphoma In progress 02/22/2018
Validation of Serious Infections among an Immunocompromised Population serious infection In progress 11/19/2017
Influenza Vaccines and Birth Outcomes cleft lip without cleft palate, cleft palate without cleft lip, cleft lip with cleft palate Complete 02/06/2019
Influenza Vaccines and Pregnancy Outcomes (PRISM) spontaneous abortion (SAB) Complete 01/26/2018
Thromboembolic Events After Immunoglobulin Administration thromboembolic events (TEE), ischemic stroke, venous thromboembolism (VTE), acute myocardial infarction (AMI) Complete 07/13/2017
Gardasil Vaccination and Venous Thromboembolism (PRISM) venous thromboembolism (VTE) Complete 04/21/2015

Outcomes Assessed in Inferential Analyses

Title Outcomes Reports Status Date Posted
Hospitalized Heart Failure Algorithm Defined in "Acute Myocardial Infarction and Hospitalized Heart Failure following Saxagliptin or Sitagliptin Use: a Propensity Score Matched Analysis" hospitalized heart failure (hHF) Complete 04/01/2019
Acute Myocardial Infarction Algorithm Defined in "Acute Myocardial Infarction and Hospitalized Heart Failure following Saxagliptin or Sitagliptin Use: a Propensity Score Matched Analysis" acute myocardial infarction (AMI) Complete 04/01/2019
Intracranial Hemorrhage Algorithm Defined in "Stroke, Gastrointestinal Bleeding, and Intracranial Hemorrhage following Apixaban or Warfarin Use in Patients with Non-Valvular Atrial Fibrillation: a Propensity Score Matched Analysis" intracranial hemorrhage Complete 02/15/2019
Ischemic Stroke Algorithm Defined in "Stroke, Gastrointestinal Bleeding, and Intracranial Hemorrhage following Apixaban or Warfarin Use in Patients with Non-Valvular Atrial Fibrillation: a Propensity Score Matched Analysis" ischemic stroke Complete 02/15/2019
Gastrointestinal Bleed Algorithm Defined in "Stroke, Gastrointestinal Bleeding, and Intracranial Hemorrhage following Apixaban or Warfarin Use in Patients with Non-Valvular Atrial Fibrillation: a Propensity Score Matched Analysis" gastrointestinal (GI) bleed Complete 02/15/2019
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 (GI) bleed Complete 06/25/2018
Gastrointestinal Bleed Algorithm Defined in "PROMPT: Rivaroxaban Surveillance, Gastrointestinal Bleed" gastrointestinal (GI) bleed 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
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
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
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 "Seizure following Ranolazine Use: a Self-Controlled Risk Interval Analysis" seizure Complete 04/24/2018
Venous Thromboembolism Algorithm Defined in "Venous Thromboembolism following Continuous or Extended Cycle Contraceptive Use: a Propensity Score Matched Analysis" venous thromboembolism (VTE) Complete 04/23/2018
Stroke Algorithm Defined in "Stroke following Atypical Antipsychotic or Z-Hypnotic Use in Patients with Prior Use of Selective Serotonin Reuptake Inhibitors (SSRIs): a Propensity Score Matched Analysis" stroke, ischemic stroke, hemorrhagic stroke Complete 04/23/2018
Stroke Algorithm Defined in "Stroke following Typical or Atypical Antipsychotic Use in non-Elderly Patients: a Propensity Score Matched Analysis" stroke, ischemic stroke, hemorrhagic stroke Complete 04/23/2018

Coding Trend Analyses

Title Outcomes Reports Status Date Posted
Coding Trend Analyses: Lung Cancer lung cancer Complete 04/25/2019
Coding Trend Analyses: Endometrial Cancer endometrial cancer Complete 04/25/2019
Coding Trend Analysis: Leukemia leukemia Complete 04/25/2019
Coding Trend Analyses: Esophageal Cancer esophageal cancer Complete 04/25/2019
Coding Trend Analyses: Lymphoma lymphoma Complete 04/25/2019
Coding Trend Analyses: Kidney and Pelvis Cancer kidney and pelvis cancer Complete 04/25/2019
Coding Trend Analyses: Cataracts cataracts Complete 04/16/2019
Coding Trend Analyses: Glaucoma glaucoma Complete 04/16/2019
Coding Trend Analyses: Nasal Polyps nasal polyps Complete 04/16/2019
Coding Trend Analyses: Heart Failure heart failure Complete 04/16/2019
Coding Trend Analyses: Nasal Septal Perforations nasal septal perforation Complete 04/16/2019
Coding Trend Analyses: Diabetes Mellitus with Pregnancy diabetes mellitus with pregnancy Complete 04/15/2019
Coding Trend Analyses: Visual Acuity visual acuity Complete 04/15/2019
Coding Trend Analyses: Blindness blindness Complete 04/15/2019
Coding Trend Analyses: Pancreatic Cancer pancreatic cancer Complete 04/12/2019
Coding Trend Analyses: Urinary Bladder Cancer urinary bladder cancer Complete 04/12/2019
Coding Trend Analyses: Malignant Melanoma Cancer malignant melanoma cancer Complete 04/09/2019
Coding Trend Analyses: Diabetic Ketoacidosis diabetic ketoacidosis Complete 04/09/2019
Coding Trend Analyses: Non-Melanoma Skin Cancer non-melanoma skin cancer Complete 04/09/2019
Coding Trend Analyses: Type 2 Diabetes Mellitus type 2 diabetes mellitus Complete 04/09/2019
Coding Trend Analyses: Type 1 Diabetes Mellitus type 1 diabetes mellitus Complete 04/09/2019
Coding Trend Analyses: Ischemic Heart Disease ischemic heart disease Complete 04/05/2019
Coding Trend Analyses: Allergic Reactions allergic reaction Complete 04/05/2019
Coding Trend Analyses: Guillain-Barré Syndrome Guillain-Barré syndrome Complete 04/03/2019
Coding Trend Analyses: Bell's Palsy Bell’s palsy Complete 04/03/2019
Coding Trend Analyses: Prostate Cancer prostate cancer Complete 04/03/2019
Coding Trend Analyses: Febrile Seizures febrile seizure Complete 04/03/2019
Coding Trend Analyses: Anaphylaxis anaphylaxis Complete 04/03/2019
Coding Trend Analyses: Thyroid Cancer thyroid cancer Complete 03/29/2019
Coding Trend Analyses: Rectal Cancer rectal cancer Complete 03/29/2019
Coding Trend Analyses: Gout gout Complete 03/28/2019
Coding Trend Analyses: Anal Cancer anal cancer Complete 03/28/2019
Coding Trend Analyses: Male Breast Cancer male breast cancer Complete 03/28/2019
Coding Trend Analyses: Colon Cancer colon cancer Complete 03/28/2019
Coding Trend Analyses: Female Breast Cancer female breast cancer Complete 03/28/2019
Coding Trend Analyses: Cervical Cancer cervical cancer Complete 03/28/2019
Coding Trend Analyses: Gestational Diabetes Mellitus gestational diabetes mellitus Complete 03/01/2019
Coding Trend Analyses: Intracranial Hemorrhage - Inpatient Care Setting intracranial hemorrhage Complete 03/01/2019
Coding Trend Analyses: Lower Limb Amputation lower limb amputation Complete 03/01/2019
Coding Trend Analyses: Intracranial Hemorrhage - Any Care Setting intracranial hemorrhage Complete 03/01/2019
Coding Trend Analyses: Angioedema angioedema Complete 09/18/2018
Coding Trend Analyses: Ischemic Stroke ischemic stroke Complete 09/18/2018
Coding Trend Analyses: Acute Myocardial Infarction acute myocardial infarction (AMI) Complete 09/18/2018
Coding Trend Analyses: Myositis myositis Complete 06/15/2018
Coding Trend Analyses: Rhabdomyolysis rhabdomyolysis Complete 06/15/2018
Coding Trend Analyses: Myocarditis myocarditis Complete 06/15/2018

Literature Reviews

Title Outcomes Reports Status Date Posted
Health Outcome Algorithm Inventory febrile seizure, venous thromboembolism (VTE), spontaneous abortion (SAB), gastrointestinal (GI) bleed, tuberculosis (TB), Achilles tendon rupture (ATR), suicide, toxic epidermal necrolysis, pulmonary fibrosis, acute respiratory failure, severe acute liver injury (SALI), Bell’s palsy, Henoch Schönlein purpura (HSP), systemic lupus erythematosus (SLE), stillbirth, attempted suicide, sudden cardiac death, erythema multiforme major, Guillain-Barré syndrome, hip fracture, idiopathic thrombocytopenic purpura, peripheral neuropathy, pulmonary hypertension, rhabdomyolysis, thrombocytopenia, agranulocytosis, type 1 diabetes mellitus, juvenile rheumatoid arthritis, 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