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drug3220 | RECOP unit patient Wiki | 0.24 |
drug63 | 40-Steps-test Wiki | 0.17 |
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drug1369 | Emergency Laparotomy Wiki | 0.17 |
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drug667 | Buprenorphine Sublingual Product Wiki | 0.17 |
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Name (Synonyms) | Correlation | |
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D051271 | Headache Disorders, Secondary NIH | 0.17 |
D005157 | Facial Pain NIH | 0.17 |
D000435 | Alcoholic Intoxication NIH | 0.17 |
Name (Synonyms) | Correlation | |
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D021821 | Communicable Diseases, Emerging NIH | 0.12 |
D006261 | Headache NIH | 0.10 |
D008881 | Migraine Disorders NIH | 0.09 |
D006323 | Heart Arrest NIH | 0.09 |
D011183 | Postoperative Complications NIH | 0.09 |
D000428 | Alcohol Drinking NIH | 0.07 |
D059352 | Musculoskeletal Pain NIH | 0.06 |
D007511 | Ischemia NIH | 0.06 |
D004417 | Dyspnea NIH | 0.05 |
D019966 | Substance-Related Disorders NIH | 0.05 |
D003141 | Communicable Diseases NIH | 0.04 |
D007251 | Influenza, Human NIH | 0.04 |
D014947 | Wounds and Injuries NIH | 0.03 |
D012141 | Respiratory Tract Infections NIH | 0.03 |
D004194 | Disease NIH | 0.03 |
D007239 | Infection NIH | 0.02 |
D016638 | Critical Illness NIH | 0.02 |
D014777 | Virus Diseases NIH | 0.02 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.01 |
D018352 | Coronavirus Infections NIH | 0.01 |
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HP:0002315 | Headache HPO | 0.10 |
HP:0002076 | Migraine HPO | 0.09 |
HP:0001695 | Cardiac arrest HPO | 0.09 |
Name (Synonyms) | Correlation | |
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HP:0002098 | Respiratory distress HPO | 0.05 |
HP:0011947 | Respiratory tract infection HPO | 0.03 |
Navigate: Correlations HPO
There are 34 clinical trials
This study aims to quantify the inpatient and ER visits burden of laboratory-confirmed influenza, and compare the clinical features, severity, complications, risk factors and socioeconomic impact of influenza in children presenting with acute respiratory illness (ARI) and/or isolated fever, with or without laboratory-confirmed influenza.
Description: ARI was defined as one or more of the following symptoms: sore throat (in children greater than or equal to (≥) 3 years old), coryza (runny nose), cough, breathing difficulties. Isolated fever was defined as: oral temperature ≥37.5°C / axillary temperature ≥37.5°C / Rectal temperature ≥38°C / tympanic temperature on oral setting ≥37.5°C / tympanic temperature on rectal setting ≥38°C without an obvious cause.
Measure: Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever Time: Day 0 till Day 28-37Description: Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days.
Measure: Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza Time: Day 0 till Day 28-37Description: Among the other laboratory-confirmed respiratory viruses there were:adenovirus, respiratory syncytial virus, parainfluenza virus 1, 2 and 3, metapneumovirus, bocavirus, rhinovirus or coronavirus. The outcome was assessed in subjects with an acute respiratory illness (ARI) and/or isolated fever episode.
Measure: Number of Subjects With Other Laboratory-confirmed Respiratory Viruses Time: Day 0 till Day 28-37Description: Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed.
Measure: Number of Subjects With Fatal Outcomes Time: Day 0 till Day 28-37Description: The outcome assessed the various complications by laboratory-confirmed influenza status.
Measure: Number of Subjects With Secondary Bacterial Infections Time: Day 0 till Day 28-37Description: Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status.
Measure: Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status Time: Day 0 till Day 28-37Description: The outcomes was assessed in subjects with laboratory-confirmed influenza status
Measure: Number of Days of Hospitalization Time: Day 0 till Day 28-37 (between October 2010 until May 2011)Description: ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Measure: Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status Time: Day 0 till Day 28-37Description: ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Measure: Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status Time: Day 0 till Day 28-37Description: ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Measure: Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status Time: Day 0 till Day 28-37Description: ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Measure: Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit Time: Day 0 till Day 28-37Description: School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status.
Measure: Number of Days of School Absenteeism Time: Day 0 till Day 28-37Description: This outcome assessed absenteeism among caregivers to provide patient care during the follow-up period by laboratory-confirmed influenza status.
Measure: Number of Days of Parent or Caregiver Time Off Work Time: Day 0 till Day 28-37Description: This outcome assessed the number of cases with household contacts presenting influenza like illness symptoms during the follow-up period by laboratory-confirmed influenza status.
Measure: Number of Subjects With Household Members With Influenza-like Illness Time: Day 0 till Day 28-37Description: This outcome assessed the proportion of influenza like illness (ILI) among household members of children < 15 years with and without laboratory-confirmed influenza.
Measure: Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever) Time: Day 0 till Day 28-37The purpose of this study is to evaluate the impact of (1) Implementation Facilitation (IF) on rates of provision of Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) treatment with referral for ongoing medication-assisted treatment (MAT) and the (2) effectiveness of IF on patient engagement in formal addiction treatment at 30 days.
Description: The primary implementation outcome will be evaluated assessing the rate of ED-initiated BUP therapy with referral for ongoing MAT over the 12 month period.
Measure: Implementation (Considered the Primary Outcome) Time: 12 monthsDescription: The primary effectiveness outcome is defined as the rates of patient engagement in formal addiction treatment on the 30th day post enrollment.
Measure: Effectiveness Time: 30 Days Post EnrollmentDescription: Fidelity will be measured using a critical action checklist relating to the provision of ED-initiated BUP with referral for ongoing MAT in eligible patients.
Measure: Implementation: Fidelity Time: Baseline Period (Baseline)Description: Fidelity will be measured using a critical action checklist relating to the provision of ED-initiated BUP with referral for ongoing MAT in eligible patients.
Measure: Implementation: Fidelity Time: IF Evaluation Period (18 months)Description: ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT
Measure: Implementation: ED provider Readiness and Preparedness Ruler Score Time: Pre IF (Baseline)Description: ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT
Measure: Implementation: ED provider Readiness and Preparedness Ruler Score Time: Post IF (6 months)Description: ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT
Measure: Implementation: ED provider Readiness and Preparedness Ruler Score Time: post IF Evaluation Period (12 months)Description: ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT
Measure: Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score Time: Pre IF (Baseline)Description: ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT
Measure: Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score Time: Post IF (6 months)Description: ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT
Measure: Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score Time: Post IF Evaluation Period (12 months)Description: Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP
Measure: Implementation: Community Readiness and Preparedness Ruler Score Time: Pre IF (Baseline)Description: Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP
Measure: Implementation: Community Readiness and Preparedness Ruler Score Time: Post IF (6 months)Description: Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP
Measure: Implementation: Community Readiness and Preparedness Ruler Score Time: post IF Evaluation Period (12 months)Description: Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP
Measure: Implementation: Community ORCA Score Time: Pre IF (Baseline)Description: Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP
Measure: Implementation: Community ORCA Score Time: Post IF (6 months)Description: Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP
Measure: Implementation: Community ORCA Score Time: post IF Evaluation Period (12 months)Description: Self-reported days of illicit opioid use (past 7 days) as measured by Time-Line Follow-Back methods at 30 days
Measure: Effectiveness: Opioid Use Time: 30 days post enrollmentDescription: Overdose event (past 30 days) captured by participant self-report, state medical examiner records, National Death Index and review of medical records
Measure: Effectiveness: Overdose Event Time: 30 days post enrollmentDescription: HIV risk taking behaviors (past 30 days) as measured by HIV Risk Taking Behavior Scale
Measure: Effectiveness: HIV Risk Time: 30 days post enrollmentDescription: All Healthcare Service Utilization Inpatient and Outpatient
Measure: Effectiveness: Healthcare Service Utilization Time: 30 days post enrollmentDescription: Rates of illicit opioid negative urines
Measure: Effectiveness: Illicit Opioid Urine Toxicology Time: 30 days post enrollmentThis study will (1) recruit, train and provide resources to approximately 30 Emergency Department (ED) sites throughout the U.S. using implementation facilitation strategies to provide ED-initiated buprenorphine (BUP) for patients presenting with opioid use disorder (OUD) who are not receiving medications for opioid use disorder (MOUD). Once implementation is adequately achieved, the sites will (2) conduct a randomized controlled trial (RCT) to compare the effectiveness of sublingual buprenorphine (SL-BUP) versus extended-release buprenorphine (XR-BUP) on ED patients' engagement in formal addiction treatment 7-days after their ED visit. In addition, in an ancillary component of the study, the investigators will (3) assess the use of XR-BUP in ED patients with Clinical Opioid Withdrawal Scale (COWS) scores < 8 in a case series to potentially expand the eligibility of patients in the larger RCT to those presenting with little to no opioid withdrawal symptoms. Finally, the investigators will (4) develop and validate ED electronic health record (EHR) opioid-related phenotypes, both of which will inform the main RCT.
Description: Engagement in formal addiction treatment will be defined as enrollment and receiving formal addiction treatment on the 7th day post randomization, confirmed by contact with the facility and/or treating clinician. Formal addiction treatment will be operationally defined as those treatments consistent with the American Society of Addiction Medicine's levels of care (1-4) and can include a range of clinical settings including office-based providers of BUP or naltrexone, opioid treatment programs (OTPs), intensive outpatient, inpatient, or residential treatments. Patients do not need to be receiving MOUD at 7 days to be considered engaged in formal addiction treatment. Participation in a mutual-help program such as Alcoholics Anonymous (AA) or (Narcotics Anonymous) NA alone will not be considered as engagement in formal addiction treatment. Additional analyses evaluating the effects of patient and site characteristics will also be conducted.
Measure: RCT Component: Patient engagement (yes/no) in formal addiction treatment at 7 days post randomization Time: 7 days post randomizationDescription: Engagement in formal addiction treatment will be defined as enrollment in formal addiction treatment on the 30th day post randomization, confirmed by direct contact with the facility and/or treating clinician. Formal addiction treatment will be operationally defined as those treatments consistent with the American Society of Addiction Medicine's levels of care (1-4) and can include a range of clinical settings including office-based providers of BUP or naltrexone, OTPs, intensive outpatient, inpatient, or residential treatments. Patients do not need to be receiving MOUD on the 30th day post randomization to be considered engaged in formal addiction treatment. Participation in a mutual-help program such as Alcoholics or Narcotics Anonymous alone will not be considered as engagement in formal addiction treatment. Additional analyses evaluating the effects of patient and site characteristics will also be conducted.
Measure: RCT Component: Patient engagement (yes/no) in formal addiction treatment at 30 days post randomization Time: 30 days post randomizationDescription: The primary economic outcome will be the incremental cost-effectiveness ratio (ICER). The ICER will be calculated as the incremental mean cost of XR-BUP relative to SL-BUP, divided by the incremental mean effectiveness of XR-BUP relative to SL-BUP. Measures of effectiveness include: engagement in formal addiction treatment at 7 days and on the 30th day; quality-adjusted life-years (QALYs) gained; and Abstinent Years, a measure of time abstinent from opioids.
Measure: RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP at 7 days post randomization Time: 7 days post randomizationDescription: The primary economic outcome will be the incremental cost-effectiveness ratio (ICER). The ICER will be calculated as the incremental mean cost of XR-BUP relative to SL-BUP, divided by the incremental mean effectiveness of XR-BUP relative to SL-BUP. Measures of effectiveness include: engagement in formal addiction treatment at 7 days and on the 30th day; quality-adjusted life-years (QALYs) gained; and Abstinent Years, a measure of time abstinent from opioids.
Measure: RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP at 30 days post randomization Time: 30 days post randomizationDescription: self-report verified with treatment provider(s)
Measure: RCT Component: Engagement in MOUD (yes/no) at 7 days post randomization Time: 7 days post randomizationDescription: The Timeline Follow-back procedure will be used to elicit the patient participant's self-reported days of use of opioids.
Measure: RCT Component: Self-reported days of illicit opioid use (past 7 days) at 7 days post randomization Time: 7 days post randomizationDescription: The Timeline Follow-back procedure will be used to elicit the patient participant's self-reported quantity of use of opioids.
Measure: RCT Component: Self-reported days (quantity) of illicit opioid use (past 7 days) at 7 days post randomization Time: 7 days post randomizationDescription: The Timeline Follow-back procedure will be used to elicit the patient participant's self-reported route of administration of use of opioids.
Measure: RCT Component: Self-reported days (route of administration) of illicit opioid use (past 7 days) at 7 days post randomization Time: 7 days post randomizationDescription: The investigators will use visual analogue scales (VAS) to assess craving, desire to use opioids and need to use opioids with a scale of 0-100.
Measure: RCT Component: Craving scores at 7 days post randomization Time: 7 days post randomizationDescription: The investigators will modify the patient satisfaction scale where overall experience is rated from 1 to 5 (1 is completely ineffective and 5 is completely effective) and treatment characteristics are rated 1 to 7 (1 is not important and 7 is extremely important) based on previous published data.
Measure: RCT Component: Patient satisfaction with BUP at 7 days post randomization Time: 7 days post randomizationDescription: self report verified with treatment provider(s)
Measure: RCT Component: Patient Engagement in MOUD (yes/no) at 30 days post randomization Time: 30 days post randomizationDescription: The Timeline Follow-back procedure will be used to elicit the patient participant's self-reported days of use of opioids.
Measure: RCT Component: Self-reported days of illicit opioid use (past 7 days) at 30 days post randomization Time: 30 days post randomizationDescription: The Timeline Follow-back procedure will be used to elicit the patient participant's self-reported quantity of use of opioids.
Measure: RCT Component: Self-reported days (quantity) of illicit opioid use (past 7 days) at 30 days post randomization Time: 30 days post randomizationDescription: The Timeline Follow-back procedure will be used to elicit the patient participant's self-reported route of administration of use of opioids.
Measure: RCT Component: Self-reported days (route of administration) of illicit opioid use (past 7 days) at 30 days post randomization Time: 30 days post randomizationDescription: A brief, structured interview regarding health care utilization (inpatient and outpatient) will be used, which collects information on the type and amount of services received. This includes ED visits, hospitalizations, primary medical care visits (excluding those for BUP treatment and self-help sources of support (e.g., NA).
Measure: RCT Component: Healthcare services utilization (past 30 days) regarding ED visits and hospitalizations at 30 days post randomization Time: 30 days post randomizationDescription: Assessment of past 30-day overdose events will be completed at 30 days post study enrollment. In addition, Site PIs will search local electronic medical records for fatal and non-fatal overdose events.
Measure: RCT Component: Overdose Events at 30 days post randomization Time: 30 days post randomizationDescription: The investigators will use a visual analogue scale (VAS) "Desire to Use" to assess craving. Participants will be asked "At this moment I desire opioids" and indicate on the line the point that corresponds to the extent to which they desire opioids. Anchors will include 0 mm - "definitely not" to 100 mm - "definitely so". At follow up daily calls they will report a number between 0 and 100.
Measure: Ancillary Component: Desire to Use post XR-BUP injection at ED Index Visit (Day 0) Time: Pre-injection and 240 minutes post injectionDescription: The investigators will use a VAS to assess bad drug effects. Participants will be asked to respond to the statement: "At this moment, I feel bad drug effects" and place a mark across the line at the point that corresponds to the extent to which they are feeling any bad drug effects. Anchors will include 0 mm - 'not at all' to 100 mm - 'extremely'.
Measure: Ancillary Component: Bad drug effects post XR-BUP injection at ED Index Visit (Day 0) Time: Pre-injection and 240 minutes post injectionDescription: Adjective Rating Scale for Withdrawal (ARSW) - The ARSW is a 16-item self-report scale that measures subjective severity of opioid withdrawal and symptoms using a scale of 1 to 9 (1 is none and 9 is severe).
Measure: Ancillary Component: Changes in withdrawal severity at post XR-BUP injection at ED Index Visit (Day 0) Time: Pre-injection and 240 minutes post-injectionDescription: Participants will report the degree of pain at the injection site after the injection is administered using a numerical rating scale ranging from 0 - no pain to 10 - worst possible pain.
Measure: Ancillary Component: Pain at injection site post XR-BUP injection at ED Index Visit (Day 0) Time: Immediately following XR-BUP injection, 30 minutes and 240 minutes post injectionDescription: Vital signs (temperature) collected while sitting, following a rest period of at least 3 minutes are used to medically monitor any changes during the 240 minute time frame.
Measure: Ancillary Component: Vital Signs (temperature) post XR-BUP injection at ED Index Visit (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: Vital signs (systolic blood pressure, mmHg) collected while sitting, following a rest period of at least 3 minutes are used to medically monitor any changes during the 240 minute time frame.
Measure: Ancillary Component: Vital Signs (blood pressure- systolic) post XR-BUP injection at ED Index Visit- (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: Vital signs (diastolic blood pressure, mmHg) collected while sitting, following a rest period of at least 3 minutes are used to medically monitor any changes during the 240 minute time frame.
Measure: Ancillary Component: Vital Signs (diastolic blood pressure) post XR-BUP injection at ED Index Visit- (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: Vital signs (pulse rate- beats per minute) collected while sitting, following a rest period of at least 3 minutes are used to medically monitor any changes during the 240 minute time frame.
Measure: Ancillary Component: Vital Signs (pulse rate) post XR-BUP injection at ED Index Visit- (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: Vital signs (respiratory rate- breaths/min) collected while sitting, following a rest period of at least 3 minutes are used to medically monitor any changes during the 240 minute time frame.
Measure: Ancillary Component: Vital Signs (respiratory rate) post XR-BUP injection at ED Index Visit- (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: Vital signs (oxygen saturation- collected while sitting, following a rest period of at least 3 minutes) collected while sitting, following a rest period of at least 3 minutes are used to medically monitor any changes during the 240 minute time frame.
Measure: Ancillary Component: Vital Signs (oxygen saturation) post XR-BUP injection at ED Index Visit- (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: Clinical Opiate Withdrawal Scale (COWS) - the COWS is a validated measure of the severity of opioid withdrawal that consists of 11 subjective and objective items. Scores on the individual items are combined to a single overall score that has been used to determine the SL-BUP induction strategy. COWS scoring, and interpretation is as follows: Score: 5-12 = mild opioid withdrawal; 13-24 = moderate opioid withdrawal; 25-36 = moderately severe opioid withdrawal; more than 36 = severe opioid withdrawal.
Measure: Ancillary Component: Changes in withdrawal severity (COWS) at post XR-BUP injection at ED Index Visit (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: The Objective Opioid Withdrawal Scale (OOWS) - The OOWS is a validated measure of the severity of opioid withdrawal that consists of 13 objective items.
Measure: Ancillary Component: Changes in withdrawal severity (OOWS) at post XR-BUP injection at ED Index Visit (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: Adjective Rating Scale for Withdrawal (ARSW) - The ARSW is a 16-item self-report scale that measures subjective severity of opioid withdrawal and symptoms using a scale of 1 to 9 (1 is none and 9 is severe).
Measure: Ancillary Component: Changes in withdrawal severity (ARSW) at post XR-BUP injection at ED Index Visit (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: This will be assessed via pupillometry. Two measurements should be taken and if they are discrepant by >0.5mm discrepant, the Research Associate will need to repeat assessment until they achieve two consecutive readings with agreement of <0.5mm. The average of the two measurements is entered.
Measure: Ancillary Component: Pupillary diameter post XR-BUP injection at ED Index Visit (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: SL-BUP and ancillary medications will be provided according to a uniform protocol. Research Associates (RAs) and nurses will document the timing and provision of all medications received before and during the 4-hour observation period in the ED. In addition, the Research Associate will review the electronic medical record to determine any additional medications or intravenous fluids were administered to the patient during their ED visit and the timing of those medications.
Measure: Ancillary Component: Provision of post Injection Medications post XR-BUP injection at ED Index Visit (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: Precipitated Withdrawal will be documented on the Precipitated Withdrawal Form along with time of occurrence.
Measure: Ancillary Component: Precipitated Withdrawal (yes/no) post XR-BUP injection at ED Index Visit (Day 0) Time: Every 30 minutes for a total of 240 minutes post XR-BUP injectionDescription: The Research Associate will assess the degree of erythema and swelling at the injection site using a 4-point rating scale ranging from 0 - none to 3-severe.
Measure: Ancillary Component: Local Tolerability post XR-BUP injection at ED Index Visit (Day 0) Time: At 30 and 240 minutes post XR-BUP injectionDescription: Clinical Opiate Withdrawal Scale (COWS) - the COWS is a validated measure of the severity of opioid withdrawal that consists of 11 subjective and objective items. Scores on the individual items are combined to a single overall score that has been used to determine the SL-BUP induction strategy. COWS scoring, and interpretation is as follows: Score: 5-12 = mild opioid withdrawal; 13-24 = moderate opioid withdrawal; 25-36 = moderately severe opioid withdrawal; more than 36 = severe opioid withdrawal.
Measure: Ancillary Component: Proportion of participants that experience a 5 or greater increase in COWS score within 4 hours of of XR-BUP administration Time: Within 4 hours of XR-BUP administrationDescription: Clinical Opiate Withdrawal Scale (COWS) - the COWS is a validated measure of the severity of opioid withdrawal that consists of 11 subjective and objective items. Scores on the individual items are combined to a single overall score that has been used to determine the SL-BUP induction strategy. COWS scoring, and interpretation is as follows: Score: 5-12 = mild opioid withdrawal; 13-24 = moderate opioid withdrawal; 25-36 = moderately severe opioid withdrawal; more than 36 = severe opioid withdrawal.
Measure: Ancillary Component: Proportion of participants that transition to moderate withdrawal (COWS 13-24) within 4 hours of XR-BUP administration Time: Within 4 hours of XR-BUP administrationDescription: The Daily Substance Use assessment solicits participant use of substances of interest daily via a text-messaging application.
Measure: Ancillary Component: Daily Substance Use (Days 1-6 post injection) Time: Days 1-6 post injectionDescription: The investigators will use a visual analogue scale (VAS) "Desire to Use" to assess craving. Participants will be asked "At this moment I desire opioids" and indicate on the line the point that corresponds to the extent to which they desire opioids. Anchors will include 0 mm - "definitely not" to 100 mm - "definitely so". At follow up daily calls they will report a number between 0 and 100 (daily via a text-messaging application).
Measure: Ancillary Component: Desire to Use (Days 1-6 post injection) Time: Days 1-6 post injectionDescription: Urine testing will be performed for the presence of the following drugs: opioids, oxycodone, benzodiazepines, cocaine, methamphetamine, amphetamine, ecstasy (MDMA), marijuana (THC), barbiturate, methadone, buprenorphine, and fentanyl.
Measure: Ancillary Component: Presence of opioids, oxycodone, benzodiazepines, cocaine, methamphetamine, amphetamine, ecstasy (MDMA), marijuana (THC), barbiturate, methadone, buprenorphine and fentanyl (7 days post injection) Time: 7 days post injectionDescription: Clinical Opiate Withdrawal Scale (COWS) - the COWS is a validated measure of the severity of opioid withdrawal that consists of 11 subjective and objective items. Scores on the individual items are combined to a single overall score that has been used to determine the SL-BUP induction strategy. COWS scoring, and interpretation is as follows: Score: 5-12 = mild opioid withdrawal; 13-24 = moderate opioid withdrawal; 25-36 = moderately severe opioid withdrawal; more than 36 = severe opioid withdrawal.
Measure: Ancillary Component: Opioid Withdrawal (7 days post injection) Time: 7 days post injectionDescription: The Daily Substance Use assessment solicits participant use of substances of interest.
Measure: Ancillary Component: Daily Substance Use (7 days post injection) Time: 7 days post injectionDescription: The investigators will use a visual analogue scale (VAS) "Desire to Use" to assess craving. Participants will be asked "At this moment I desire opioids" and indicate on the line the point that corresponds to the extent to which they desire opioids. Anchors will include 0 mm - "definitely not" to 100 mm - "definitely so". At follow up daily calls they will report a number between 0 and 100
Measure: Ancillary Component: Desire to Use (7 days post injection) Time: 7 days post injectionDescription: At 7-day follow up the participant will be queried about pain, itching, discharge and tenderness at the site. Study staff will examine the patient for erythema at the injection.
Measure: Ancillary Component: Injection Site Reactions (7 days post injection) Time: 7 days post injectionDescription: Participant satisfaction and preference will be assessed using quantitative and qualitative mixed methods at 7-day follow-up. Satisfaction will be rated on a Likert 1-5 scale by the participant, and preference order ranking to receive ongoing treatment with SL-BUP, preference to receive ongoing treatment with XR-BUP, and preference to not receive any formulation of BUP will be ranked. The investigators will use open-ended questions to explore patient satisfaction, preference and study experience.
Measure: Ancillary Component: Patient satisfaction with BUP (7 days post injection) Time: 7 days post injectionDescription: A brief, structured interview (not scored) regarding health care utilization (inpatient and outpatient) will be used, which collects information on the type and amount of services received. This includes ED visits, hospitalizations, primary medical care visits (excluding those for BUP treatment and self-help sources of support (e.g., NA).
Measure: Ancillary Component: Health Services Utilization (7 days post injection) Time: 7 days post injectionDescription: At 7 days post enrollment, participants will be asked to report OUD treatment received. Data will be reported on the Engagement in Treatment - Patient Survey (not scored).
Measure: Ancillary Component: Engagement in Treatment (7 days post injection) Time: 7 days post injectionDescription: Assessment of past 30-day overdose events will be completed at day 7 In addition, Site PIs will search local electronic medical records for fatal and non-fatal overdose events.
Measure: Ancillary Component: Overdose Events (7 days post injection) Time: 7 days post injectionThe epidemic due to the Sars-CoV2 virus is spreading in France, without knowning precisely since when the virus has actually circulated on the territory. Data from China but also systematic samples taken from the passengers of the Diamond Princess boat also report almost 50% of asymptomatic forms of Covid-19. The medical and paramedical staff of the front-line services for the care of patients infected with Covid-19 are in fact potentially exposed to the risk of occupational contamination due to the large number of patients treated, including in the pre-epidemic phase. Therefore, and despite the application of standard protective measures, it is possible that a certain number of these personnel already have or will contract Covid-19 disease, including in its asymptomatic form.
Description: Sars-CoV2 seroconversion is defined by a T0 sample with no specific antibody (negative) and M3 sample with the presence of specific IgG.
Measure: Quantify the proportion of patients with documented Sars-CoV2 infection among medical and paramedical staff Time: 3 monthsDescription: "Age, gender, type of staff, medical staff: resident, Clinic Chief or University Hospital Assistant (CCA / AHU), Associate Practitioner (PA), Contractual Hospital Practitioner (PHC), Hospital Practitioner (PH), Lecturer-Hospital Practitioner (MCU-PH) , University Professor-Hospital Practitioner (PUPH) non-medical staff: nursing assistants (AS), nurses (IDE), physiotherapist, managers, others, Seniority in the profession (number of years) Service tenure (years), Night, day, day or mixed work, Type of service: emergency department, infectious disease service, ICU), Type of hospital (firstline reference hospital or not), Documented contact with a confirmed patient."
Measure: Identification of risk factors for seroconversion Time: 3 monthsDescription: "Seroconversion without clinical manifestation (fever, body aches, headache, sweating, chills + respiratory symptoms (cough dyspnea, sputum) or digestive (nausea / vomiting diarrhea abdominal pain) reported via the weekly self-monitoring booklet. The asymptomatic characteristics will be determined by an adjudication committee, in the light of the weekly self-monitoring notebooks, without knowing the results of the serologies."
Measure: Quantify the proportion of asymptomatic infections among staff who have seroconverted Time: 3 monthsDescription: "Description of symptomatic infections Clinical manifestations associated with seroconversion. On the intermediate sample if necessary, performed within 10 days of the start of a clinical picture compatible with an acute Sars-CoV2 infection (fever, body aches, headache, sweating, chills + respiratory picture (cough dyspnea, sputum, ) or digestive (nausea / vomiting diarrhea abdominal pain) "
Measure: " Describe symptomatic infections for personnel developing acute clinical (respiratory or digestive) viral syndrome " Time: 3 monthsThe study aims at clarifying whether early treatment with continuous positive airway pressure (CPAP) ventilation is able to reduce the need for intubation or death in patients visiting an emergency department (ED) with known or suspected COVID-19 infection and insufficiency respiratory.
Description: The study outcomes will be death or need of intubation within 7 days since ED arrival.
Measure: Death or need of intubation Time: 7 days since ED arrivalDescription: 30-day mortality
Measure: 30-day mortality Time: 30 days since ED arrivalArriving in December 2019, Coronavirus COVID-19 infection is causing a global pandemic with high morbidity and mortality among adults and especially seniors. The child appears little or no affected by this infection. It is estimated that the child could be asymptomatic or pauci-symptomatic carrier and thus be vector of the disease. For this reason, measures have been taken to close schools and contain populations in a large number of countries, including France. However, there are no data on the prevalence of COVID-19 in children.
Description: children admitted to pediatric emergencies for respiratory signs Children hospitalized as a result of travelling to pediatric emergency departments for respiratory signs Respiratory asymptomatic children admitted to pediatric emergencies
Measure: Prevalence of positivity of COVID-19 virus measured by rt-PCR in the following subpopulations of emergency patients Time: at the end an average 28 daysDescription: the degree of relationship with these contacts and the time spent in contact with them within 24 hours before emergency
Measure: Contact frequency Time: At inclusionSince December 2019, when the novel coronavirus disease (Covid-19) spread throughout the world, data have been needed on the effects of the pandemic on various aspects of healthcare systems. Recommendations for social distancing and quarantine decrees made by local governments, alongside the general public fear from the spread of the virus, are presumed to have markedly affected the trends in hospitals visits. Understanding the exact nature of the effect is critical for better anticipating and preparing health systems in the event of future outbreaks and in the post outbreak period. Therefore we intend to To identify retrospectively all patients who presented to the emergency department at our medical institute between January 1 - March 31 in the following years: 2017, 2018, 2019, 2020. We will examine the impact of COVID-19 on the rates of surgical emergency visits, ratio of surgical visits to non-surgical visits, the ratio of severe presentations to non-severe presentations, and the impact of age on ED attendance.
Patients with COVID-19 usually present in the ED and receive their initial medical check-up here. We will try to gather information of comorbidities and other conditions at the time of presentation of COVID-19 patients to the ED. The course of the disease prior to admission as well as the momentary health status at presentation to the ED are of interest because they influence risk stratification and decision-making of treating physicians. The ratio of patients with mild or moderate to severe symptoms will help to calculate the need for hospital beds including beds on Intensive Care Units (ICU) and Intermediate Care Units (IMC), as well as the need for other hospital resources.
Description: Identification of risk factors present at the earliest stage of hospital care (i.e. in the ED) that warrant hospital admission.
Measure: Identification of risk factors present at the earliest stage of hospital care (i.e. in the ED) that warrant hospital admission. Time: 6 monthsDescription: Determination of the course of the disease (days since onset of symptoms, nature of symptoms, e.g. fever, chills, headache) and the state at which patients present to the ED
Measure: Determination of the course of the disease (days since onset of symptoms, nature of symptoms, e.g. fever, chills, headache) and the state at which patients present to the ED Time: 6 monthsDescription: Identification of the ratio of patients with mild or moderate to severe disease
Measure: Identification of the ratio of patients with mild or moderate to severe disease Time: 6 months"For 12 years, the odontology service of the Pitié-Salpêtrière hospital group (GHPS) has been responsible for day and night dental emergency care. Several surveys have been conducted in order to analyze the sociological characteristics of the patients and the typology of the acts performed. These studies indicate that pain is the main reason for consultations, cited by 60 to 80% of patients. So far, very few studies have been done in the context of emergencies. Very recently, a study was undertaken on the satisfaction of patients consulting the odontological emergencies of the GHPS, during a thesis work. This study, carried out in collaboration with the URC Pitié Salpêtrière, under analysis, relates to the satisfaction of patients consulting the odontological emergencies of the GHPS during the day and week, Monday to Friday, excluding night and week emergencies -end (WE). An additional study (URGDENT-NW) aiming at completing this study by focusing on patients consulting the emergency room at night and during the weekend is also in progress. The COVID19 Crisis changed the organization and the venue of patients at the emergency dental service. Therefore this project, based on the same protocol as URGENT and URGDENT-WE, aims at evaluating the Odontology Emergency Reception Service (SAUO) during the COVID 19 epidemy. It will be carried out in the form of a survey whose objective is to assess: on the one hand, the effectiveness of the care provided in this emergency functional unit, and on the other hand the satisfaction of the patients after their passage to the emergency room ."
Description: "Self report measure of pain on the numeric scale 24h after the visit "
Measure: Pain score evolution measured by a 0-10 numeric scale (NS) where 0 is no pain and 10 the worst pain imaginable Time: Day 1Description: the pain is measured with the numeric scale
Measure: Pain scores evolution 3 days and 7 days after first visit measured by a numeric scale where 0 is no pain and 10 the worst pain imaginable Time: Day 3 and Day 7Description: Perception of welcoming, waiting time will be measured with a 0-10 numeric scale
Measure: welcoming quality from hospital staff Time: Day 1Description: The patient anxiety will be measured by numeric scale at Day 0, Day 1, Day 3, Day 7
Measure: anxiety score Time: Day 0, Day 1, Day 3, Day 7Description: The perception is measured just after care with a 0-10 numeric scale
Measure: perception of the technical quality of the emergency treatment Time: Day 1To provide ruxolitinib through an expanded access program for the treatment of cytokine storm due to COVID-19 in the United States to patients who are eligible but not able to be hospitalized or who are hospitalized with a clinical diagnosis and/or positive test for SARD-CoV-2 infection.
The current COVID-19 pandemic, this is especially since the transmission of SARS-CoV-2 is thought to occur mainly through respiratory droplets generated by coughing and sneezing, by direct contact with contaminated surfaces and because in a large number of patients COVID-19 disease may be asymptomatic. As recommended by the CDC medical personnel should be equipped with full personal protective equipment (PPE) for AGP in contact with suspected/confirmed COVID-19 patient. Therefore, it is reasonable to search for the most effective methods of intravascular access in those conditions.
Description: successful placement of intravascular device
Measure: successful rate of first intravascular access attempt Time: 1 dayDescription: number of attempts to successful access
Measure: number of attempts to successful access Time: 1 dayDescription: time to therapy including but not limited to time to fluids, antibiotics, and antiarrythmics
Measure: time to infusion Time: 1 dayDescription: complication rates
Measure: complication rates Time: 1 dayDescription: self-reported percentage the vocal cord visualization. A 100% score is a extremely difficult procedure. A Ease of use score of 1% means that procedure is extremely easy
Measure: ease of use Time: 1 dayDescription: participants were asked which method of intravascular access they would prefer in a real-life resuscitation.
Measure: Preferred intravascular access method Time: 1 dayThe current COVID-19 pandemic, this is especially since the transmission of SARS-CoV-2 is thought to occur mainly through respiratory droplets generated by coughing and sneezing, by direct contact with contaminated surfaces and because in a large number of patients COVID-19 disease may be asymptomatic. As recommended by the CDC medical personnel should be equipped with full personal protective equipment (PPE) for AGP in contact with suspected/confirmed COVID-19 patient. Therefore, it is reasonable to search for the most effective methods of intravascular access in those conditions.
Description: successful placement of intravascular device
Measure: Success rate of first intravascular access attempt Time: 1 dayDescription: time to successful access
Measure: time to successful access Time: 1 dayDescription: number of attempts to successful access
Measure: number of attempts to successful access Time: 1 dayDescription: time to therapy including but not limited to time to fluids, antibiotics, and antiarrythmics
Measure: time to infusion Time: 1 dayDescription: complication rates
Measure: complication rates Time: 1 dayDescription: the rate of survival to hospital admission
Measure: ROSC Time: 1 dayThis research aims to improve knowledge of the epidemiology of patients consulting in the COvid Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID19 affects France and impacts its health system. The reception of all intermediate patients will be on the Emergency Structures (SU). Indeed, the French healthcare system centralizes unscheduled urgent care on the ER. The aspecific respiratory symptomatology in "intermediate" patients indicates them all the more at an admission to SU or the diagnostic approach to respiratory difficulty may be carried out. It will be necessary to identify the diagnosis of the dyspneic patient and to define his virological status COVID before referring him to the appropriate units. The investigatory propose an original strategy of dedicating entire care sectors to the care of patients admitted for dyspnea in our ER. These units will be named RECOP units. This study would improve epidemiological knowledge of COVID-19 and ability to receive these patients within the SU.
Description: The virological condition will be taken with PCR tests on naso-pharyngeal samples or on sputum for patients taking
Measure: Describe the characteristics of patients admitted to reCOP units according to their virological status vis-à-vis COVID-19 Time: 30 daysDescription: demographic variables, usual history and treatments, episode characteristics (symptomatology, evolution, treatment taken) and data from the initial clinical examination will be collected by doctor
Measure: Develop a predictive model of the risk of being COVID for patients admitted to the emergency room for dyspnea Time: 0 daysDescription: Virological status will be collected by a phone call at the patient
Measure: Virological status Time: 30 daysDescription: Mortality status will be collected by a phone call at the patient
Measure: Mortality status Time: 30 daysThe purpose of this study is to develop a safe, easily scalable, and simple method to split a single ventilator for use amongst two or more patients, thus serving as a capacity bridge to save patient lives until manufacturers can produce enough ventilators.
Description: This outcome will measure whether the device will function for respiratory support for 1 minute (yes or no; phase 1 only)
Measure: Completion of 1-minute test Time: Up to 1 minuteDescription: This outcome will measure whether the device will function for respiratory support for 24 hours (yes or no; phase 2 only)
Measure: Completion of 24-hour test Time: Up to 1 minuteDescription: This outcome will measure whether the device will function for respiratory support for 1 hour (yes or no; phase 3 only)
Measure: Completion of 24-hour test Time: Up to 1 hourIn the context of the COVID-19 pandemic, Emergency Department (ED) are in front line for the reception of patients presenting COVID-19 symptoms and have to face a new situation given the expected number of patients. Staff participate in suspect patients triage, in the diagnosis and the management of Covid-19 patients, having to follow the instructions and recommendations that evolve in real time, depending on the stage, resources and means available. This situation requires that the staff immediately adaptation within this reorganization and redeployment of the activity. Then; they are subject to many stress and anxiety factors such as: - Increased activity: massive influx of patients, overload of work, lack of material and human resources - Modification of practices: training in procedures, measures isolation and prevention of contamination of other patients, replacement by professionals reassigned from other departments - Ethical dilemma: decisions to be made in an emergency, patient prioritization - Numerous, evolving information, from various sources and sometimes contradictory (national, governance, service, media) - Individual: fear of personal contamination and of those close to you, personal organization in a situation of confinement of the population, loss of usual social support - Anxiety and stress management of patients and relatives, their entourage and colleagues In this study, it is proposed to study the psychic impact of the COVID-19 pandemic on emergency department staff.
Description: The level of stress will be measured using the Chamoux et Simard visual analogic scale. This scale is composed of 3 subscales evaluating the stress level at work, at home and in the life in general. Each scale are rating from 0 to 10, 0 being the absence of stress and 10 the highest level of stress ever experienced a cotation at each scale greater than 6 will defined the presence of a stress.
Measure: Change of emergency department staff's level of stress during the covid19 pandemic, measured using the Chamoux et Simard visual analogic scale Time: Every 15 days from baseline to 3 monthsDecember 2019 was the onset of an outbreak of an infection related to SARS-CoV-2, a new coronavirus detected in January 2020 and responsible for a disorder termed COVID-19. Since then, COVID-19 has spread worldwide and is responsible for an unprecedented pandemic with major threat on global health and social and economic stability. Covid-19 has a large spectrum of symptoms. Most patients experience mild or moderate flu-like disorder with cough, fever, and shortness of breath. More severe presentations may occur; patients sometimes develop an acute pneumonia that can lead to adult respiratory distress syndrome. A considerable number of publications have been released for the last 10 weeks to help physicians making diagnosis and treat patients. Chinese authors have extensively proposed description of the disease. As signs and symptoms are poorly specific, diagnosis mostly relies on detection of the virus by RT-PCR in the upper respiratory tract. Some uncommon images and localization are highly specific and sensitive on chest CT-scan, which is cornerstone for initial diagnosis. However, resources may lack during healthcare crisis and results of these investigations may be delayed or unavailable developper. Special attention should also be paid to usual laboratory analysis. Indeed, decreased lymphocytes and eosinophilic counts are frequently described as well as increase in D-dimers levels. Variation of C-reactive protein (CRP) and procalcitonin (PCT) have been reported. Coronavirus may have cardiac tropism and changes in cardiac biomarkers concentration may occur. Therefore, some data suggest that values of routine biomarkers and blood cell count may assist physicians at bedside to support diagnosis of COVID-19. To face the outbreak, organization of emergency departments (ED) was mandatory to separate patients flows and avoid mixing patients with COVID-19 and others. Most patients visiting EDs dedicated to initial COVID-19 management suffered of pneumonia-like symptoms. Despite initial triage, patients had either COVID-19-related pneumonia either alternative diagnoses. We took advantage of this to evaluate the ability of routine biomarkers and leucocytes count helping identification of COVID-19 from alternative diagnoses.
Description: assess sensitivity of routine biomarkers and blood cell count for diagnosis of COVID-19-related pneumonia in low and high probability groups for level of certainty using the adjudication committee classification
Measure: routine biomarkers and blood cell count are discriminant to diagnose COVID-19 Time: 2 monthsDescription: An adjudication committee with full access to medical charts will classify patients in 4 categories for diagnosis of COVID-19 associated pneumonia : certain, probable, unlikely, and excluded. Patients will be distributed in 2 probability groups : high probability (certain + probable) and compared with low probability patients (unlikely + excluded). Se, Sp, PPV, NPV, Likelihood ratios will be assessed comparing the 2 groups regarding CRP.
Measure: Probability of COVID-19 and CRP Time: 2 monthsDescription: An adjudication committee with full access to medical charts will classify patients in 4 categories for diagnosis of COVID-19 associated pneumonia : certain, probable, unlikely, and excluded. Patients will be distributed in 2 probability groups : high probability (certain + probable) and compared with low probability patients (unlikely + excluded). Se, Sp, PPV, NPV, Likelihood ratios will be assessed comparing the 2 groups regarding PCT.
Measure: Probability of COVID-19 and PCT Time: 2 monthsDescription: An adjudication committee with full access to medical charts will classify patients in 4 categories for diagnosis of COVID-19 associated pneumonia : certain, probable, unlikely, and excluded. Patients will be distributed in 2 probability groups : high probability (certain + probable) and compared with low probability patients (unlikely + excluded). Se, Sp, PPV, NPV, Likelihood ratios will be assessed comparing the 2 groups regarding Ddimers.
Measure: Probability of COVID-19 and Ddimers Time: 2 monthsDescription: An adjudication committee with full access to medical charts will classify patients in 4 categories for diagnosis of COVID-19 associated pneumonia : certain, probable, unlikely, and excluded. Patients will be distributed in 2 probability groups : high probability (certain + probable) and compared with low probability patients (unlikely + excluded). Se, Sp, PPV, NPV, Likelihood ratios will be assessed comparing the 2 groups regarding NTproBNP.
Measure: Probability of COVID-19 and NTproBNP Time: 2 monthsDescription: An adjudication committee with full access to medical charts will classify patients in 4 categories for diagnosis of COVID-19 associated pneumonia : certain, probable, unlikely, and excluded. Patients will be distributed in 2 probability groups : high probability (certain + probable) and compared with low probability patients (unlikely + excluded). Se, Sp, PPV, NPV, Likelihood ratios will be assessed comparing the 2 groups regarding cTnT-HS.
Measure: Probability of COVID-19 and cTnT-HS Time: 2 monthsDescription: An adjudication committee with full access to medical charts will classify patients in 4 categories for diagnosis of COVID-19 associated pneumonia : certain, probable, unlikely, and excluded. Patients will be distributed in 2 probability groups : high probability (certain + probable) and compared with low probability patients (unlikely + excluded). Se, Sp, PPV, NPV, Likelihood ratios will be assessed comparing the 2 groups regarding blood cell counts.
Measure: Probability of COVID-19 and blood cell counts Time: 2 monthsDescription: Assess performance of combined routine biomarkers and blood cell count for diagnosis of COVID-19-related pneumonia independent parameters that will significantly differ in a univariate analysis will be combined. Their characteristics will be reported (Se, Sp, PPV, NPV, Likelihood ratios). The above mentioned assessment will be held at the exclusion of others
Measure: performance of combined routine biomarkers Time: 2 monthsDescription: ii) to assess performance of combined routine biomarkers and blood cell count for diagnosis of COVID-19-associated pneumonia; assessment of characteritics for high probability and low probability patients : P value and AUC [95% CI] will be assessed comparing the 2 groups. iii) to assess whether usual biomarkers and blood cell count were associated with diagnosis of COVID-19-associated pneumonia using sensitivity analyses in predefinite subgroups chosen a priori; 1) when comparing definite versus excluded patients; 2) when comparing high vs. low probability patients, excluding bacterial infection (respiratory and extra-respiratory) in the low probability COVID-19-associated pneumonia group; 3) when comparing definite versus excluded probability patients, excluding bacterial infections (respiratory and extra-respiratory) in excluded patients. For each, P value and AUC [95% CI] will be assessed comparing the 2 groups
Measure: Assess usual biomarkers and blood cell count Time: 2 monthsThere is a critical need to determine the impact of the COVID-19 emergency on the comprehensive well-being of people as they are living through the emergency and sequelae of the emergency period. The research team is requesting National Institutes of Health funding with the goal to investigate rural vs. urban living people's response to the crisis and its impact using mixed methods research.
Description: participant responses about quality of life during COVID-19 emergency
Measure: World Health Organization Quality of Life-Brief Scale Time: From enrollment until post-event (Feb. 2021)Description: Participants responses to open-ended interview questions regarding alteration in daily life routines
Measure: Open-ended Interview Time: From enrollment until post-event (Feb. 2021)Medication Overuse Headache (MOH) is a disabling condition that affects the 2% of migraine population. Medication overuse (MO) makes this condition very difficult to treat. The literature of the last decades confirm the efficacy of withdrawal for patients with medication overuse, but it is also confirmed that patients have to be carefully followed after withdrawal to avoid relapses and to improve the clinical benefit of the therapeutic approach. Clinical results can be improved when traditional therapies are combined with behavioral approaches in particular mindfulness, that help patient to become more conscious about their symptoms and able to manage pain without medication. As the emergency situation due to the Corona-virus pandemic phenomenon in Italy, the regular clinical practice adopted for patients with CM-MO has changed in the last weeks: patients cannot come to the hospital for the withdrawal iv therapy and for regular follow up as the reduced mobility due to the emergency in particular in the Lombardia region, but all over Italy. So the investigators propose a pilot study to enforce the application of a Home-program for the withdrawal procedure for patients and the use of technology like smartphone and video calls so that patients can continue to be followed in their therapeutic process by using behavioral support and mindfulness practice. Patients will perform the withdrawal program at home, by oral administration of therapies, with specific instructions and education. Also the information for behavioral approach and mindfulness practice will be given, to use every day at home. Daily standardized mindfulness sessions of 12 minutes on their smartphone will be combined with weekly video-call to evaluate the clinical condition and to encourage the use strategies for pain management. Face-to-face visits at the follow up every three months will be scheduled. This modality will allow the patients to continue their therapeutic process and to be regularly followed during the one year after withdrawal.
Description: Drop-out rates after withdrawal treatment
Measure: Drop out rates Time: at 12 monthsDescription: Percentages of patients with absence of Medication Overuse Headache
Measure: Absence of Medication Overuse Headache (MOH) Time: at 12 months from withdrawal program (assessed by Daily Diary Card)NLR has previously been observed to correlate with complications in upper GI (1) and colorectal (2) surgery. The investigators sought to assess if a similar correlation can be identified in emergency general surgical patients and if the presence of suspected or confirmed COVID-19 may impact on this. Given the heterogeneity of emergency general surgery the investigators therefore plan to perform a retrospective review of patients having emergency laparotomies only at a single NHS site during COVID-19 pandemic. Assessment of outcomes and Neutrophil:lymphocyte ratio as a predictor of outcomes will be completed. Outcomes will be completed in line with the recent COVIDSurg study criteria (3). The primary outcome is 30-day mortality. Secondary outcomes are 7-day mortality, re-operation, length of stay, post-operative respiratory failure, post-operative ARDS (Acute Respiratory Distress Syndrome), post-operative sepsis and ITU (Intensive Therapy Unit)/HDU (High Dependency Unit) admission.
Description: Mortality
Measure: 30-day mortality Time: 30 daysDescription: Mortality
Measure: 7-day mortality Time: 7 daysDescription: Re-operation
Measure: Number of participants returning to theatre Time: 30 daysDescription: Inpatient stay during index admission
Measure: Length of stay Time: 30 daysDescription: Presence of respiratory failure in the post-operative period as defined in the clinical notes or discharge summaries
Measure: Post-operative respiratory failure Time: 30 daysDescription: ARDS diagnosed radiologically
Measure: Post-operative ARDS Time: 30 daysDescription: Presence of sepsis in the post-operative period as defined in the clinical notes or discharge summaries
Measure: Post-operative sepsis Time: 30 daysDescription: ITU/HDU admission post-operatively
Measure: ITU/HDU admission Time: 30 daysDescription: Other documented post-operative complications
Measure: Other complications Time: 30 daysDescription: Neutrophil:Lymphocyte Ratio will be recorded daily in the peri-operative period
Measure: Peri-operative NLR Time: First 3 post-operative daysDescription: Absolute platelet counts recorded daily in the peri-operative period
Measure: Post-operative platelet counts Time: First 3 post-operative daysDescription: Defined as the presence of increased PT (prothrombin time) OR APTT (activated partial thromboplastin time) OR TT (thrombin time) OR fibrinogen above 1.5X the upper limit of normal. Coagulation will either be defined as normal or abnormal for each patient if one or more of these derangement are identified.
Measure: Post-operative coagulopathy Time: First 3 post-operative daysThis research aims to improve our knowledge of the epidemiology of patients consulting in the COvid-19 Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID-19 affects France and impacts its health system. The reception of all intermediate patients will be on the Emergency Structures (SU). Indeed, the French healthcare system centralizes unscheduled urgent care on the ER. The aspecific respiratory symptomatology in "intermediate" patients indicates them all the more at an admission to SU or the diagnostic approach to respiratory difficulty may be carried out. A central issue of this diagnostic strategy will be to be rapid, since the diagnosis will have to be made in the context of significant flows, with a need to quickly refer patients to the most suitable downstream service, while limiting the risk contamination of caregivers and vulnerable patients if a COVID-19 + patient is admitted to an unsuitable service. However, virological tests do not currently allow rapid results for COVID-19. Research project of investigatory aims to develop a predictive model of the risk of being COVID-19 positive for patients admitted to the emergency room for acute dyspnea.
Description: demographic variables, usual history and treatments, episode characteristics (symptomatology, evolution, treatment taken) and data from the initial clinical examination will be collected by doctor
Measure: Develop a predictive model of the risk of being COVID-19 for patients admitted to the emergency room for dyspnea Time: inclusion dayDescription: The COVID-19 virological condition will be taken with PCR tests on naso-pharyngeal samples or on sputum for patients taking
Measure: Describe the characteristics of patients admitted to reCOP units according to their virological status Time: 30 daysDescription: Virological status will be collected by a phone call at the patient
Measure: Virological status Time: 30 daysDescription: Mortality status will be collected by a phone call at the patient
Measure: Mortality status Time: 30 daysOpen-label randomized clinical trial, one center, to compare the need for face-to-face re-consultation after discharge for COVID-19 between a telematic monitoring through a mobile app and the regular primary care setting.
Description: Number of patients needing face-to-face re-consultations
Measure: Re-consultation Time: 2 weeksDescription: Number of patients making telephone calls to emergency services
Measure: Telephone calls Time: 2 weeksEmergency general surgical care during the COVID-19 pandemic presents a unique set of considerations and challenges. Patients presenting with acute surgical conditions and concomitant COVID-19 infection have higher risk of mortality and morbidity. The investigators present their experience with COVID-19 positive patients presenting with acute surgical conditions and reviewed the implementation of a protocolized pathway to mitigate the impact of COVID-19 infection.
This is a retrospective analytical study conducted at Vascular and Endovascular surgery Department, Mansoura University Hospital, including all patients admitted at the two periods first six months of 2019 and 2020.To demonstrate the effect of COVID-19 pandemic on the practice of emergency vascular surgery and critical limb threatening ischemia interventions by comparison two periods first six months of 2019 and 2020.
Description: The ICU admission caused by Pneumonia proved radio-logically at both periods
Measure: The ICU admission with associated Pneumonia Time: 6 monthsDescription: percentage of different diagnoses at both periods
Measure: Impact of COVID-19 on the different presentation of vascular surgery at the emergency Time: 6 monthsDescription: Mortality percentages at both periods
Measure: Mortality rates Time: 6 monthsThe overall objective of this investigation is to understand the patient response to a robotic platform used to facilitate telehealth triage in the emergency department during the COVID-19 pandemic. The COVID-19 pandemic has altered the manner in which emergency department triage is completed. Attempts at cohorting individuals with potential COVID-19 disease in order to prevent disease transmission to healthcare workers and minimize the use of personal protective equipment (PPE) have renewed interest in telemedical solutions as a method to triage and manage individuals with COVID-19. This investigation deploys a legged robotic platform to facilitate agile, highly mobile telemedicine to manage COVID-19 patients in the emergency department. The primary objective is to measure the patient response to interacting with these systems.
Description: Quantitative questionnaire on the acceptance of virtual robotic care graded on a likert scale (higher scores better)
Measure: Acceptance of robotic telehealth system Time: Immediately after completion of triageDescription: Quantitative questionnaire on the willingness to use this system again based on a likert scale (higher scores better)
Measure: Willingness to interact with robotic telehealth system Time: Immediately after completion of triageDescription: Quantitative questionnaire on the user satisfaction with their triage experience (How satisfied were you with your experience interacting with the robotic system today?)
Measure: Satisfaction of interacting with a robotic telehealth system Time: Immediately after completion of triageDescription: Quantitative questionnaire comparing robotic triage process with in-person triage: Do you think your interaction with the robotic system was better, the same or no different than an in-person evaluation?)
Measure: Use of robotic system versus in-person triage Time: Immediately after completion of triageHealthcare renunciation is defined as: "Individuals give up care when they do not seek services and health care professionals when they experience a disorder, experience a physical or mental disorder, or when they do not access all of the prescribed care." In 2008, 16.5% of the general French population reported having renounced care. The causes mentioned of the renunciation are mainly the financial difficulties, the deadlines of appointments considered too long, the geographical remoteness. In the department of Sarthe, the rate of cessation of care is estimated at 27.6% over the period from 2014 to 2017. In the context of the COVID-19 epidemic, containment was applied in France counted from 17 March 2020. The widespread message was "save lives, stay at home". The Ministry of Solidarity and Health has provided health professionals with a circular to adapt the management of patients with chronic disease, requiring elective surgical care and pregnant women. The decline in activity of general practitioners is estimated at 44% and that of other specialists at 71%. In Paris, visits to the emergency room fell by 45% for adults and 70% for children. The main risk is the deterioration of the health status of some patients with the worsening of chronic diseases, the discovery of pathologies during episodes of decompensation and the absence of management of serious acute pathologies. The study aims to assess the importance of giving up care during this period of COVID-19 and in comparison with a study conducted at the University Hospital of Angers and the hospital of Le Mans in 2017.
This feasibility study is being conducted to understand how discharged emergency department patients who were tested for the SARS-CoV-2 virus (COVID-19) engage with a symptom-tracking web application. Study participants that are enrolled in the study will be asked to enter daily information about their health into the CovidX web application (app.). In addition, patients will answer questions regarding anxiety levels, use a pulse oximeter to record information (if you own one or are given one). The investigators predict that participants will be able to engage with the CovidX web application over several days to weeks for the purposes of symptom tracking, and may have decreased anxiety over the study period.
Description: The proportion of patients approached for the study who enroll
Measure: Recruitment rate Time: through study completion an average of 1 yearDescription: The PROMIS Emotional Distress-Anxiety-Short Form 4a is a 4-item scale that assesses fear, anxiety, worry, and uneasiness. It uses a 5-point Likert scale (1 = never to 5 = always). Raw scores range from 4-20 with lower scores representing less endorsement of anxiety.
Measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety short form 4a Time: completed at baseline (enrollment), up to 30 daysDescription: This is a 5- item questionnaire that assess anxiety related to the Coronavirus. Participants select from (0 = not at all to 4 = nearly every day over the last 2 weeks). The higher the total number the more anxiety.
Measure: Change in Coronavirus Anxiety Scale Time: completed at baseline (enrollment), up to 30 daysDescription: The questionnaire is a series of 8 questions answered on a 1-7 Likert scale, with lower numbers indicating better usability. There are also 2 open-ended questions about why participants did or didn't like the application and other feedback is collected.
Measure: CovidX web application usability and utility measured adapted by mHealth App Usability Questionnaire Time: 30 daysDescription: This will be measured by the compliance rates
Measure: Differences in CovidX web application engagement between patients who do and do not receive a pulse oximeter Time: 30 daysThe Primary objective is to explore ambulance service attendance at incidents involving alcohol and/or substance use over the period of the pandemic lockdown, and the following months. This will be to determine prevalence and explore factors such as patient gender, age, ethnicity or location. Analysis will examine the calls over the course of the year prior to the lockdown, and then compare this to the period of lockdown and following months.
Description: Counts of attendances for alcohol and drug use by the East Midland's Ambulance Service over the time period. This will be a number per day of people attended.
Measure: Attendances for alcohol and drug use Time: Full data set 23/03/2019 compared to 22/03/2021 to look at interruption (lockdown) in the time series.COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. The aim of this multi-centered study is to guide for the approach, organization, diagnosis and treatment of the patients admitted due to trauma to emergency department during the pandemic period.
Description: within the study period, trauma patients who admitted to any of the seven study centers will be recorded.
Measure: trauma admissions Time: 3 monthsA multi-centre, observational cohort study will be carried out in consecutive patients operated on for urgent digestive pathology. Two cohorts will be defined: the 'pandemic' cohort, which will include all patients [COVID-19-positive or negative] operated on for emergency digestive pathology during the months of March to June 2020; and the control cohort, which will include all patients operated on for emergency digestive pathology during the months of March to June 2019. Information will be gathered on demographic characteristics, clinical and analytical parameters, scores on the usual risk scales for quality management in a General Surgery service (POSSUM, P-POSSUM and LUCENTUM scores), prognostic factors applicable to all patients, specific factors for patients infected with SARS-CoV-2, complications and postoperative mortality (at 30 and 90 postoperative days). In the pandemic cohort it will be detailed whether or not the patient was infected with SARS-CoV-2. The main objective will be to determine the incidence of postoperative complications and mortality. This variable will be analysed in the "full analysis set" population. Secondary objective will be to develop a specific postoperative risk propensity model for SARS-CoV-2 infected patients.
Description: Mortality for any cause at 30 days after urgent gastrointestinal surgery.
Measure: 30-day mortality Time: 30 days post-surgeryDescription: Mortality for any cause within 90 days of surgery
Measure: 90-day mortality Time: 90 days post-surgeryDescription: Postoperative complications within 30 days of surgery: classic postoperative complications, typical complications after digestive surgery and/or complications specifically associated with the evolution of COVID-19
Measure: Postoperative complications Time: 30 days post-surgeryDescription: Postoperative complications within 30 days of surgery graded as equal or superior to IIIA grade according to the Clavien-Dindo classification
Measure: Severe complications Time: 30 days post-surgeryDescription: Number of days of hospital stay from the day of admission to the date of hospital discharge or death
Measure: Lenght of stay Time: 90 days post-surgeryCOVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Emergency departments also carried out an important part of the fight against pandemics in our country/Turkey. The emergency department including an intensive care unit is very few in this country/Turkey and the only hospital, which has an Emergency Intensive Care Unit (EICU) in Istanbul, is the study center. Therefore, this retrospective study aimed to provide useful information about how an effective EICU should be, especially how to use them during pandemic periods.
Description: Mortality of the COVID-19 patients who followed up by emergency department ICU
Measure: Mortality of the COVID-19 patients Time: 3 monthsCommunication with patients on their clinical status is important in delivering care in the emergency department. During times of high volume or complex patients, there may be lapses in communicating with patients about their hospital course or plans of action. These miscommunications may be enhanced during the current COVID-19 pandemic as there is minimized in-person interaction with patients in order to conserve personal protective equipment and decrease the risk of disease transmission. This study utilizes a virtual white board to deliver updates to patients about the status of their emergency department stay.
Description: Satisfaction of overall emergency department stay measured by a 1-5 likert scale, hospital developed question on satisfaction (how satisfied were you with your emergency department stay today?)- higher score is better
Measure: emergency department satisfaction: likert scale Time: 30 minutes after disposition decision for patientDescription: Quality of information conveyed to participant (rated on 5 point likert scale on questions about quality of waiting time for test results, staff concern, perceived teamwork in the hospital)
Measure: Quality of emergency department stay: likert scale Time: 30 minutes after disposition decision for patientDescription: Question on preference for virtual white board compared to a standard emergency department room without a white board (1-4 likert scale, with 4 being strongly prefer white board room)
Measure: Preference for virtual white board Time: 30 minutes after disposition decision for patientThis is a pragmatic controlled clinical trial taking place in the first phase of COVID-19 lockdown re-opening in Spain. Patients of 52 chiropractic clinics were invited to participate in a pseudo-random order (one out of every three contacted patients) as they were contacted to either schedule an appointment with their current chiropractor or not, depending on the clinic's and the patient's availability. Patients would receive chiropractic in-person care (one or more than one visits) or no care at all, for a two-week period. According to the care received, they were assigned to one of three groups (receiving no care, receiving care once, and more than once). Participants filled an online questionnaire with self-reported outcome-measures at the beginning of the two week period. A follow-up questionnaire was completed 14 days after.
Description: Numerical rating scale (0-10, 0 meaning no pain, 10 meaning worst pain imaginable)
Measure: Pain intensity Time: 14 daysDescription: Likert Scale from better (1) to worst (4) outcomes, 1: occasionally, 4: constantly
Measure: Pain frequency Time: 14 daysDescription: Likert Scale of self-perceived improvement, from better (1) to worst (5) outcomes, 1: much better, 5: much worse
Measure: Pain evolution Time: 14 daysDescription: Validated subscale form the Brief Pain Inventory, 6 categories from 0 to 10 each, the lower, the better outcomes, out of a minimal of 0 and total of 60.
Measure: Pain interference Time: 14 daysDescription: Validated questionnaire. Short version 4 items, Likert scale from 0 to 4, lowest score (0) better outcomes, highest score (16) worst outcomes
Measure: Pain Catastrophizing Scale Time: 14 daysDescription: Validated questionnaire. Short version 11 items, Likert scale from 1 to 4, lowest score (11) better outcomes, highest score (44) worst outcomes
Measure: Tampa Scale Kinesiophobia Time: 14 daysDescription: Validated questionnaire 7 items, Likert scale from 0 to 3, lowest score (0) better outcomes, highest score (21) worst outcomes
Measure: General Anxiety Disorder scale Time: 14 daysDescription: Validated questionnaire. Short version 12 items, Likert scale from 1 to 5, lowest score (12) better outcomes, highest score (60) worst outcomes
Measure: Intolerance of Uncertainty Scale Time: 14 daysDescription: Validated questionnaire 10 items, Likert scale from 1 to 10, lowest score (10) WORST outcomes, highest score (100) BETTER outcomes
Measure: General Self-Efficacy scale Time: 14 daysDescription: Questionnaire, subscale 10 items, Likert scale from 1 to 4, lowest score (1) WORST outcomes, highest score (40) BETTER outcomes
Measure: Fear of Illness and Virus Evaluation Time: 14 daysSince 2000, various emerging infectious diseases have repeatedly caused serious impact on the health of the global population and the healthcare systems. With the growing international transportation and improving accessibility of the healthcare systems, hospitals have been inevitably the first sentinels dealing with emerging infectious diseases. The biological disasters, such as the Severe Acute Respiratory Syndrome (SARS) in 2003, the Middle East Respiratory Syndrome (MERS) outbreak in South Korean in 2015, and the Coronavirus disease 2019 (COVID-19) outbreak this year, challenged our vulnerable healthcare systems and caused great loss of lives. Regarding the ongoing global epidemics and possible community outbreaks of the COVID-19, the management of biological disasters for an overcrowded emergency department should be planned. In the early 2020, the emergency department used a double-triage and telemedicine method to treat non-critical patient with suspected COVID-19. This application reduced the exposure time of the first responders and reserve adequate interview quality. However, for the critical patients treated in the isolated resuscitation rooms, the unique environment limited the teamwork and communication for the resuscitation team. These factors might led to poorer quality of critical care. The investigators designed a telemedicine-teamwork model, which connected the isolation room, prepare room and nursing station by an video-conferencing system in the emergency department. This model try to break the barriers of space between the rooms and facilitate the teamwork communications between each unit. Besides, by providing a more efficient workflow, this model could lower the total exposure time for all workers in the contaminated area. This study was conducted to evaluate the benefits of the telemedicine-teamwork model and provide a practical, safe and effective alternative to critical care of the patients with suspected highly infectious diseases.
Description: Team Emergency Assessment Measure, minimal score is 0 and the maximal score is 4. Higher score means a better outcome.
Measure: teamwork score Time: immediately after interventionExertional desaturation is a feature of COVID-19. The study will measure vital signs of patients discharge by practitioners in primary care, secondary care or by paramedic practitioners. Patients will then undertake a 40-steps on the spot walk followed by measurements of heart rate and oxygen saturations for up to two minutes. Association of desaturation with 30 days hospital admission and mortality will be reported.
Description: No change Further investigations Hospital admission a) No change b) Further investigations c) Hospital admission
Measure: Change in decision to discharge Time: 24 hoursDescription: Admission to hospital within 30 days of the test
Measure: Hospital Time: 30 daysDescription: Death within 30 days of the test
Measure: Death Time: 30 daysDescription: Proportion of sites and patients able to undertake the test
Measure: Feasibility of the 40-steps test Time: 12 monthsDescription: Change in heart rate compared to value measured before expercise
Measure: Change in heart rate Time: Within 2 minutes of completion of the testDescription: Change in heart rate compared to value measured before exercise
Measure: Change in oxygen saturations Time: Within 2 minutes of completion of the testDescription: Change in respiratory rate compared to value measured before exercise
Measure: Change in respiratory rate Time: Within 2 minutes of completion of the testDescription: Change in breathlessness compared to value measured before exercise
Measure: Change in breathlessness Time: Within 2 minutes of completion of the testAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports