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| Name | Class |
|---|---|
| American Academy of Pediatrics | OTHER |
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The proposal will focus on 3 specific, high-risk, pediatric ambulatory diagnostic errors each representing a unique dimension of diagnostic assessment: evaluation of symptoms, evaluation of signs and follow-up of diagnostic tests. Adolescent depression (i.e. symptoms) affects nearly 10% of teenagers, is misdiagnosed in almost 75% of adolescents and causes significant morbidity. Pediatric elevated blood pressure (signs) is misdiagnosed in 74-87% of patients, often due to inaccurate application of blood pressure parameters that change based on age, gender and height. Actionable pediatric laboratory values (diagnostic tests) are potentially delayed up to 26% of the time in preliminary investigations and 7-65% in adults, leading to harm and malpractice claims.
The investigators propose to conduct a multisite, prospective, stepped wedge cluster randomized trial testing a quality improvement collaborative (QIC) intervention within the American Academy of Pediatrics' Quality Improvement Innovation Networks (QuIIN) to reduce the incidence of pediatric primary care diagnostic errors. QuIIN is a national network of over 300 primary care practices, ranging from tertiary care academic medical centers to single practitioner private practices, interested in and experienced with QICs. Because many processes are likely to be common across diagnostic errors in outpatient settings, a multifaceted intervention, such as a QIC, has a high likelihood of success and broad applicability across populations. Preparatory inquiries to QuIIN primary care providers suggest high interest in reducing these 3 diagnostic errors and provider agreement with randomization to evaluate diagnostic error interventions. Practices will be randomized to one of three groups, with each group collecting retrospective baseline data on one error above, and then intervening to reduce that error during the first eight months. Each group will concurrently collect control data on an error they are not intervening on during those eight months. Following those eight months, the groups will continue intervening on their first error, begin intervening on the error they were a control site for, and begin collecting data on the third error for which they will be a control site for. Finally, in the final eight months, all groups will intervene on all three errors. A second wave of practices will be recruited to join the groups after eight months and will only intervene on two of the three errors.
Objectives:
Primary
• To determine whether a QIC consisting of evidence-based best-practice methodologies, mini-root cause analyses, data sharing, and behavior change techniques, is associated with a reduction in 3 specific diagnostic error rates in a national group of pediatric primary care practices.
Secondary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduce Elevated Blood Pressure Errors First | Experimental | Will provide baseline data on elevated blood pressure diagnosis and first intervene to reduce missed opportunities for elevated blood pressure diagnosis. Will then intervene to reduce missed opportunities for depression diagnosis and finally, intervene to reduce delayed diagnosis attributable to abnormal laboratory values. Quality Improvement Collaborative Intervention will consist of behavioral components, i.e., training, interactions with experts, root cause analyses of errors, idea sharing, best practices dissemination, etc. |
|
| Reduce Depression Errors First | Experimental | Will provide baseline data on depression diagnosis and first intervene to reduce missed opportunities for depression diagnosis. Will then intervene to reduce delayed diagnosis attributable to abnormal laboratory values and finally, intervene to reduce missed opportunities for elevated blood pressure diagnosis. Quality Improvement Collaborative Intervention will consist of behavioral components, i.e., training, interactions with experts, root cause analyses of errors, idea sharing, best practices dissemination, etc. |
|
| Reduce Lab Related Errors First | Experimental | Will provide baseline data on delayed diagnosis attributable to abnormal laboratory values and first intervene to reduce delayed diagnosis attributable to abnormal laboratory values. Will then intervene to reduce missed opportunities for elevated blood pressure diagnosis results and finally, to reduce missed opportunities for depression diagnosis. Quality Improvement Collaborative Intervention will consist of behavioral components, i.e., training, interactions with experts, root cause analyses of errors, idea sharing, best practices dissemination, etc. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality Improvement Collaborative | Behavioral | 1)Every 8 month 1-2 day interactive webinar learning sessions 2)Monthly webinars sharing best practices 3)Monthly team interactions with dedicated QI coach 4)Monthly data submission on both process and outcome measures 5)Monthly data feedback both at aggregate level with full inter-team transparency as well as at institutional level 6)Monthly mini root cause analyses performed on 1 error at each site 7)Multidisciplinary teams consisting of at least a physician, nurse, and office practice associate 8)Instruction on best practices from content area experts in QI, diagnostic errors, hypertension, mental health, leadership, behavior change, Model for Understanding Success in Quality (MUSIQ) and EHRs 9)Ongoing sharing of best ideas and barriers/issues among institutional teams |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adolescents Diagnosed With Depression Seen in Well Child Visits | Patients >=11 years old with documentation of major depression or subsyndromal depression diagnoses in the medical record | Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) |
| Number of Patients With Elevated Blood Pressure Measured and Appropriately Acted on by Providers | Systolic or Diastolic Blood Pressure >= 90th percentile for age, gender and height or >=120/80 in >=3 years old patients at well child visits and at least one of: 1) provider repeated blood pressure, 2) clinic note mentions elevated blood pressure/hypertension 3) plan included recheck or evaluation of blood pressure, or 4) ordering laboratory or other studies to evaluate elevated blood pressure | Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) |
| Number of Patients With Abnormal Laboratory Results With Appropriate Actions Without Delay | Documented action step for first positive within 30 days:
Documented action step for first positive within 7 days:
| Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adolescents With Mental Health Addressed During Their Well Child Visit | Provider screened for mental health concerns either with standard screening tool or clinical judgement and documented mental health concerns or no mental health concerns. | Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Clinics Reaching Pre-Determined Threshold for Providers With Laboratory Results Unread/Unacknowledged in Their Electronic Health Record (EHR) Inbox for More Than 72 Hrs | Clinics reported percent of EHR inboxes with laboratory results unread/unacknowledged in their electronic health record (EHR) inbox for more than 72 hrs each month. They reported whether this percentage was equal to or less than 10%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months. |
Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Academy of Pediatrics | Elk Grove Village | Illinois | 60007 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30720339 | Derived | Bundy DG, Singh H, Stein RE, Brady TM, Lehmann CU, Heo M, O'Donnell HC, Rice-Conboy E, Rinke ML. The design and conduct of Project RedDE: A cluster-randomized trial to reduce diagnostic errors in pediatric primary care. Clin Trials. 2019 Apr;16(2):154-164. doi: 10.1177/1740774518820522. Epub 2019 Feb 5. |
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Of note, initial control data were collected prior to the first Intervention Period
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Blood Pressure, Depresion, Labs | A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors. |
| FG001 | Group 2: Depression, Labs, Blood Pressure | A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors. |
| FG002 | Group 3: Labs, Blood Pressure, Depression | A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention Period |
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| Second Intervention Period |
| |||||||||||||||||||
| Third Intervention Period |
|
Each error had variable numbers of patients in the intervention and control groups
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Reduce Elevated Blood Pressure Errors | A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors. Data presented aggregates all control and intervention phase data respectively, from all three cohorts. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Each error had an intervention and control group |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Adolescents Diagnosed With Depression Seen in Well Child Visits | Patients >=11 years old with documentation of major depression or subsyndromal depression diagnoses in the medical record | Posted | Count of Participants | Participants | Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) |
|
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As this quality improvement research study was considered low risk, no adverse event data was collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reduce Elevated Blood Pressure Errors | Will provide baseline data on elevated blood pressure diagnosis and first intervene to reduce missed opportunities for elevated blood pressure diagnosis. Will then intervene to reduce missed opportunities for depression diagnosis and finally, intervene to reduce delayed diagnosis attributable to abnormal laboratory values. Each group provides control data and intervention data on all 3 errors in different sequences. Three Wave 2 practices were recruited to increase power and they intervened on only 2 errors. Quality Improvement Collaborative: 1)Every 8 month 1-2 day interactive webinar learning sessions 2)Monthly webinars sharing best practices 3)Monthly team interactions with dedicated QI coach 4)Monthly data submission on both process and outcome measures 5)Monthly data feedback both at aggregate level with full inter-team transparency as well as at institutional level 6)Monthly mini root cause analyses performed on 1 error at each site 7)Multidisciplinar |
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Practices enrolled in a QIC are likely not representative of all practices. Appropriate actions broadly defined. No direct chart review verifications. No data on 11 practices who left the study. Quasi-random chart review strategy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Rinke | Children's Hospital at Montefiore and Albert Einstein College of Medicine | 718-741-2597 | mrinke@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2016 | Sep 9, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D018798 | Anemia, Iron-Deficiency |
| D013290 | Streptococcal Infections |
| D012749 | Sexually Transmitted Diseases |
| D020264 | Lead Poisoning, Nervous System, Childhood |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
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|
|
| Number of Patients With Elevated Blood Pressures Measured and Blood Pressure Percentiles Documented in the Chart | Systolic or Diastolic Blood Pressure >= 90th percentile for age, gender and height or >=120/80 in >=3 years old patients at well child visits with blood pressure percentiles documented per the 4th Report. | Collected Monthly (5-0 baseline months and 8-9 intervention months depending on the enrolled cohort) |
| Number of Patients With Elevated Blood Pressures Measured and Recognized by Provider | Systolic or Diastolic Blood Pressure >= 90th percentile for age, gender and height or >=120/80 in >=3 years old patients at well child visits with provider documentation of abnormal blood pressure or appropriate action taken | Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) |
| Number of Patients With Abnormal Laboratory Results Received and Recognized by Provider | Provider documentation of abnormal laboratory value, of appropriate diagnosis (e.g. iron deficiency anemia) or appropriate action taken without delay as defined above. | Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) |
| Collected at 4 months |
| Percent of Clinics Reaching Pre-determined Threshold for Children Greater Than or Equal to 3 Yrs Old Receiving Blood Pressure Measurements at Triage for Well Child Visits | Clinics reported percent of well child visit charts with blood pressure measurements at triage done each month. They reported whether this percentage was equal to or greater than 90%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months. | Collected until 2 months |
| Percent of Clinics Reaching Predetermined Threshold for Adolescents Screened for Depression With Patient Health Questionnaire-9 Modified (PHQ-9M) During Well Child Visits | Clinics reported percent of adolescent well child visit charts with depression screening done each month. They reported whether this percentage was equal to or greater than 90%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months. | Collected monthly for 8 months when practice is intervening on this topic |
| Intervention Data Error 2 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Intervention Data Error 3 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Reduce Depression Errors | A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors. Data presented aggregates all control and intervention phase data respectively, from all three cohorts. |
| BG002 | Reduce Lab Related Errors | A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors. Data presented aggregates all control and intervention phase data respectively, from all three cohorts. |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Each error had an intervention and control group | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Insurance Status | Each error had an intervention and control group | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Number of Patients With Elevated Blood Pressure Measured and Appropriately Acted on by Providers | Systolic or Diastolic Blood Pressure >= 90th percentile for age, gender and height or >=120/80 in >=3 years old patients at well child visits and at least one of: 1) provider repeated blood pressure, 2) clinic note mentions elevated blood pressure/hypertension 3) plan included recheck or evaluation of blood pressure, or 4) ordering laboratory or other studies to evaluate elevated blood pressure | Posted | Count of Participants | Participants | Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) |
|
|
|
|
| Primary | Number of Patients With Abnormal Laboratory Results With Appropriate Actions Without Delay | Documented action step for first positive within 30 days:
Documented action step for first positive within 7 days:
| Posted | Count of Participants | Participants | Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) |
|
|
|
|
| Secondary | Number of Adolescents With Mental Health Addressed During Their Well Child Visit | Provider screened for mental health concerns either with standard screening tool or clinical judgement and documented mental health concerns or no mental health concerns. | Posted | Count of Participants | Participants | Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) |
|
|
|
|
| Secondary | Number of Patients With Elevated Blood Pressures Measured and Blood Pressure Percentiles Documented in the Chart | Systolic or Diastolic Blood Pressure >= 90th percentile for age, gender and height or >=120/80 in >=3 years old patients at well child visits with blood pressure percentiles documented per the 4th Report. | Posted | Count of Participants | Participants | Collected Monthly (5-0 baseline months and 8-9 intervention months depending on the enrolled cohort) |
|
|
|
|
| Secondary | Number of Patients With Elevated Blood Pressures Measured and Recognized by Provider | Systolic or Diastolic Blood Pressure >= 90th percentile for age, gender and height or >=120/80 in >=3 years old patients at well child visits with provider documentation of abnormal blood pressure or appropriate action taken | Posted | Count of Participants | Participants | Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) |
|
|
|
|
| Secondary | Number of Patients With Abnormal Laboratory Results Received and Recognized by Provider | Provider documentation of abnormal laboratory value, of appropriate diagnosis (e.g. iron deficiency anemia) or appropriate action taken without delay as defined above. | Posted | Count of Participants | Participants | Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) |
|
|
|
|
| Other Pre-specified | Percent of Clinics Reaching Pre-Determined Threshold for Providers With Laboratory Results Unread/Unacknowledged in Their Electronic Health Record (EHR) Inbox for More Than 72 Hrs | Clinics reported percent of EHR inboxes with laboratory results unread/unacknowledged in their electronic health record (EHR) inbox for more than 72 hrs each month. They reported whether this percentage was equal to or less than 10%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months. | Posted | Count of Units | Clinics | Collected at 4 months | Clinics | Clinics |
|
|
|
| Other Pre-specified | Percent of Clinics Reaching Pre-determined Threshold for Children Greater Than or Equal to 3 Yrs Old Receiving Blood Pressure Measurements at Triage for Well Child Visits | Clinics reported percent of well child visit charts with blood pressure measurements at triage done each month. They reported whether this percentage was equal to or greater than 90%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months. | Posted | Count of Units | Clinics | Collected until 2 months | Clinics | Clinics |
|
|
|
| Other Pre-specified | Percent of Clinics Reaching Predetermined Threshold for Adolescents Screened for Depression With Patient Health Questionnaire-9 Modified (PHQ-9M) During Well Child Visits | Clinics reported percent of adolescent well child visit charts with depression screening done each month. They reported whether this percentage was equal to or greater than 90%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months. | Posted | Count of Units | Clinics | Collected monthly for 8 months when practice is intervening on this topic | Clinics | Clinics |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Reduce Depression Errors | Will provide baseline data on depression diagnosis and first intervene to reduce missed opportunities for depression diagnosis. Will then intervene to reduce delayed diagnosis attributable to abnormal laboratory values and finally, intervene to reduce missed opportunities for elevated blood pressure diagnosis. Each group provides control data and intervention data on all 3 errors in different sequences. Two Wave 2 practices were recruited to increase power and they intervened on only 2 errors. Quality Improvement Collaborative: 1)Every 8 month 1-2 day interactive webinar learning sessions 2)Monthly webinars sharing best practices 3)Monthly team interactions with dedicated QI coach 4)Monthly data submission on both process and outcome measures 5)Monthly data feedback both at aggregate level with full inter-team transparency as well as at institutional level 6)Monthly mini root cause analyses performed on 1 error at each site 7)Multidisciplinary teams cons | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Reduce Lab Related Errors | Will provide baseline data on delayed diagnosis attributable to abnormal laboratory values and first intervene to reduce delayed diagnosis attributable to abnormal laboratory values. Will then intervene to reduce missed opportunities for elevated blood pressure diagnosis results and finally, to reduce missed opportunities for depression diagnosis. Each group provides control data and intervention data on all 3 errors in different sequences. Four Wave 2 practices were recruited to increase power and they intervened on only 2 errors. Quality Improvement Collaborative: 1)Every 8 month 1-2 day interactive webinar learning sessions 2)Monthly webinars sharing best practices 3)Monthly team interactions with dedicated QI coach 4)Monthly data submission on both process and outcome measures 5)Monthly data feedback both at aggregate level with full inter-team transparency as well as at institutional level 6)Monthly mini root cause analyses performed on 1 error at ea | 0 | 0 | 0 | 0 | 0 | 0 |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020263 | Lead Poisoning, Nervous System |
| D020260 | Heavy Metal Poisoning, Nervous System |
| D020258 | Neurotoxicity Syndromes |
| D009422 | Nervous System Diseases |
| D007855 | Lead Poisoning |
| D000075322 | Heavy Metal Poisoning |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| Between 18 and 65 years |
|
| >=65 years |
|
| Title | Measurements |
|---|---|
| <=18 years |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Title | Measurements |
|---|---|
| Female |
|
| Male |
|
| Non-private Insurance |
|
| Title | Measurements |
|---|---|
| Private Insurance |
|
| Non-private Insurance |
|