<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03797313</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00197235</org_study_id>
    <secondary_id>00181895</secondary_id>
    <secondary_id>K01HL141637-01</secondary_id>
    <nct_id>NCT03797313</nct_id>
  </id_info>
  <brief_title>Observational Study of Expected ARF Recovery</brief_title>
  <acronym>OSEAR</acronym>
  <official_title>Observational Study of Expected Acute Respiratory Failure (ARF) Recovery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational cohort study of the association between patient expectations for&#xD;
      functional recovery and quality of life among acute respiratory failure survivors 6 months&#xD;
      after hospital discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will enroll adults who are diagnosed with acute respiratory failure during an ICU&#xD;
      admission and discharged from the ICU alive. All participants will receive usual clinical&#xD;
      care. Participant expectations for functional recovery will be assessed before hospital&#xD;
      discharge via a standardized questionnaire containing a visual analogue scale and questions&#xD;
      about expected ability and importance of being able to perform activities of daily living and&#xD;
      instrumental activities of daily living in 6 months. At 6 months, participants will be&#xD;
      re-contacted by phone. Study staff will administer questionnaires to assess whether patient&#xD;
      expectations have been met. Quality of life will be assessed using the WHOQOL-BREF and the&#xD;
      EQ-5D-VAS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 22, 2019</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life measured using the World Health Organization Quality of Life-BREF instrument (WHOQOL-BREF) after hospital discharge</measure>
    <time_frame>6 months after hospital discharge</time_frame>
    <description>WHOQOL-BREF is a measure of overall quality of life that evaluates satisfaction with important aspects of life rather than of health. The instrument contains 26 items across 4 domains, and requires approximately 5 minutes to administer over the phone. The 26 items in the WHOQOL-BREF are scored in four domains: physical, psychological, social relations, and environment, with between 3 and 8 items in each domain and two &quot;benchmark&quot; items addressing overall QoL. Transforming the raw scores results in a domain score between 0 - 100, enabling comparisons between domains with different numbers of items. Higher scores indicate greater participant satisfaction with their quality of life and lower scores indicate worse satisfaction with quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient expectation error measure using EQ-5D VAS</measure>
    <time_frame>6 months after hospital discharge</time_frame>
    <description>A secondary analysis will estimate patient expectation error, defined as the difference between the health-related quality of life score expected at hospital discharge and the actual health related quality of life score assessed using the EQ-5D VAS 6 months after hospital discharge. The EQ-5D VAS ranges from 0 to 100 with 0 representing the worst imaginable health state and 100 representing the best imaginable health state.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">180</enrollment>
  <condition>Acute Respiratory Failure</condition>
  <condition>Post Intensive Care Syndrome</condition>
  <arm_group>
    <arm_group_label>Patient's expectations met at Hospital discharge</arm_group_label>
    <description>ARF survivors whose expectations for recovery at hospital discharge are fully met 6 months later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient's with unmet expectations at Hospital Discharge</arm_group_label>
    <description>ARF survivors whose expectations for recovery at hospital discharge are not fully met 6 months later.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        survivors of acute respiratory failure (ARF) who are expected to be discharged home alive.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Respiratory failure managed in the ICU, where respiratory failure is defined as ≥1 of&#xD;
             the following:&#xD;
&#xD;
          -  Mechanical ventilation via an endotracheal tube ≥ 24 hours OR&#xD;
&#xD;
          -  Non-invasive ventilation (CPAP, BiPAP) ≥ 24 consecutive hours* provided for acute&#xD;
             respiratory failure (not for Obstructive Sleep Apnea or other stable use) OR&#xD;
&#xD;
          -  High flow nasal cannula with FIO2 ≥ 0.5 and flow rate ≥ 30 LPM for ≥ 24 consecutive&#xD;
             hours*&#xD;
&#xD;
             *Occasional rest periods of ≤ 1 hour each are not deducted from the calculation of&#xD;
             consecutive hours.&#xD;
&#xD;
          -  Expected by the clinical team to be discharged home alive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient in ICU &lt; 24 hours&#xD;
&#xD;
          -  Mechanical ventilation at baseline or mechanical ventilation solely for airway&#xD;
             protection or obstruction&#xD;
&#xD;
          -  Residing in a medical institution at the time of hospital admission&#xD;
&#xD;
          -  Homeless / Prisoner / Primary residence not in the USA / Unable to communicate by&#xD;
             telephone in English&#xD;
&#xD;
          -  More than mild dementia (either known diagnosis of moderate or worse dementia or&#xD;
             IQ-CODE &gt; 3.6; screening performed on patients &gt; 50 years old or with family reports&#xD;
             of possible memory decline)&#xD;
&#xD;
          -  Patient on hospice at or before time of enrollment&#xD;
&#xD;
          -  Patients who, based solely on pre-existing medical problems (such as poorly controlled&#xD;
             neoplasm or other end stage disease, including Stage IV heart failure or severe&#xD;
             burns), would not be expected to survive 6 months in the absence of the acute&#xD;
             respiratory failure.&#xD;
&#xD;
          -  Patients with neurological injury either receiving treatment for intracranial&#xD;
             hypertension or who are not expected to return to consciousness.&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alison Turnbull</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Rubenfeld GD, Caldwell E, Peabody E, Weaver J, Martin DP, Neff M, Stern EJ, Hudson LD. Incidence and outcomes of acute lung injury. N Engl J Med. 2005 Oct 20;353(16):1685-93. doi: 10.1056/NEJMoa050333.</citation>
    <PMID>16236739</PMID>
  </reference>
  <reference>
    <citation>Cox CE, Docherty SL, Brandon DH, Whaley C, Attix DK, Clay AS, Dore DV, Hough CL, White DB, Tulsky JA. Surviving critical illness: acute respiratory distress syndrome as experienced by patients and their caregivers. Crit Care Med. 2009 Oct;37(10):2702-8. doi: 10.1097/CCM.0b013e3181b6f64a.</citation>
    <PMID>19865004</PMID>
  </reference>
  <reference>
    <citation>Spragg RG, Bernard GR, Checkley W, Curtis JR, Gajic O, Guyatt G, Hall J, Israel E, Jain M, Needham DM, Randolph AG, Rubenfeld GD, Schoenfeld D, Thompson BT, Ware LB, Young D, Harabin AL. Beyond mortality: future clinical research in acute lung injury. Am J Respir Crit Care Med. 2010 May 15;181(10):1121-7. doi: 10.1164/rccm.201001-0024WS. Epub 2010 Mar 11.</citation>
    <PMID>20224063</PMID>
  </reference>
  <reference>
    <citation>Zambon M, Vincent JL. Mortality rates for patients with acute lung injury/ARDS have decreased over time. Chest. 2008 May;133(5):1120-7. doi: 10.1378/chest.07-2134. Epub 2008 Feb 8.</citation>
    <PMID>18263687</PMID>
  </reference>
  <reference>
    <citation>Phua J, Badia JR, Adhikari NK, Friedrich JO, Fowler RA, Singh JM, Scales DC, Stather DR, Li A, Jones A, Gattas DJ, Hallett D, Tomlinson G, Stewart TE, Ferguson ND. Has mortality from acute respiratory distress syndrome decreased over time?: A systematic review. Am J Respir Crit Care Med. 2009 Feb 1;179(3):220-7. doi: 10.1164/rccm.200805-722OC. Epub 2008 Nov 14.</citation>
    <PMID>19011152</PMID>
  </reference>
  <reference>
    <citation>Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.</citation>
    <PMID>21946660</PMID>
  </reference>
  <reference>
    <citation>Hopkins RO, Suchyta MR, Kamdar BB, Darowski E, Jackson JC, Needham DM. Instrumental Activities of Daily Living after Critical Illness: A Systematic Review. Ann Am Thorac Soc. 2017 Aug;14(8):1332-1343. doi: 10.1513/AnnalsATS.201701-059SR.</citation>
    <PMID>28463657</PMID>
  </reference>
  <reference>
    <citation>Kamdar BB, Huang M, Dinglas VD, Colantuoni E, von Wachter TM, Hopkins RO, Needham DM; National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome Network. Joblessness and Lost Earnings after Acute Respiratory Distress Syndrome in a 1-Year National Multicenter Study. Am J Respir Crit Care Med. 2017 Oct 15;196(8):1012-1020. doi: 10.1164/rccm.201611-2327OC.</citation>
    <PMID>28448162</PMID>
  </reference>
  <reference>
    <citation>Lieu TA, Au D, Krishnan JA, Moss M, Selker H, Harabin A, Taggart V, Connors A; Comparative Effectiveness Research in Lung Diseases Workshop Panel. Comparative effectiveness research in lung diseases and sleep disorders: recommendations from the National Heart, Lung, and Blood Institute workshop. Am J Respir Crit Care Med. 2011 Oct 1;184(7):848-56. doi: 10.1164/rccm.201104-0634WS.</citation>
    <PMID>21965016</PMID>
  </reference>
  <reference>
    <citation>Carson SS, Goss CH, Patel SR, Anzueto A, Au DH, Elborn S, Gerald JK, Gerald LB, Kahn JM, Malhotra A, Mularski RA, Riekert KA, Rubenfeld GD, Weaver TE, Krishnan JA; American Thoracic Society Comparative Effectiveness Research Working Group. An official American Thoracic Society research statement: comparative effectiveness research in pulmonary, critical care, and sleep medicine. Am J Respir Crit Care Med. 2013 Nov 15;188(10):1253-61. doi: 10.1164/rccm.201310-1790ST.</citation>
    <PMID>24160906</PMID>
  </reference>
  <reference>
    <citation>Cox CE, Martinu T, Sathy SJ, Clay AS, Chia J, Gray AL, Olsen MK, Govert JA, Carson SS, Tulsky JA. Expectations and outcomes of prolonged mechanical ventilation. Crit Care Med. 2009 Nov;37(11):2888-94; quiz 2904. doi: 10.1097/CCM.0b013e3181ab86ed.</citation>
    <PMID>19770733</PMID>
  </reference>
  <reference>
    <citation>Lamas DJ, Owens RL, Nace RN, Massaro AF, Pertsch NJ, Gass J, Bernacki RE, Block SD. Opening the Door: The Experience of Chronic Critical Illness in a Long-Term Acute Care Hospital. Crit Care Med. 2017 Apr;45(4):e357-e362. doi: 10.1097/CCM.0000000000002094.</citation>
    <PMID>27632675</PMID>
  </reference>
  <reference>
    <citation>Turnbull AE, Davis WE, Needham DM, White DB, Eakin MN. Intensivist-reported Facilitators and Barriers to Discussing Post-Discharge Outcomes with Intensive Care Unit Surrogates. A Qualitative Study. Ann Am Thorac Soc. 2016 Sep;13(9):1546-52. doi: 10.1513/AnnalsATS.201603-212OC.</citation>
    <PMID>27294981</PMID>
  </reference>
  <reference>
    <citation>Thompson AG, Sunol R. Expectations as determinants of patient satisfaction: concepts, theory and evidence. Int J Qual Health Care. 1995 Jun;7(2):127-41. doi: 10.1093/intqhc/7.2.127.</citation>
    <PMID>7655809</PMID>
  </reference>
  <reference>
    <citation>Gonzalez Saenz de Tejada M, Escobar A, Herrera C, Garcia L, Aizpuru F, Sarasqueta C. Patient expectations and health-related quality of life outcomes following total joint replacement. Value Health. 2010 Jun-Jul;13(4):447-54. doi: 10.1111/j.1524-4733.2009.00685.x. Epub 2010 Jan 15.</citation>
    <PMID>20088892</PMID>
  </reference>
  <reference>
    <citation>Soroceanu A, Ching A, Abdu W, McGuire K. Relationship between preoperative expectations, satisfaction, and functional outcomes in patients undergoing lumbar and cervical spine surgery: a multicenter study. Spine (Phila Pa 1976). 2012 Jan 15;37(2):E103-8. doi: 10.1097/BRS.0b013e3182245c1f.</citation>
    <PMID>21629159</PMID>
  </reference>
  <reference>
    <citation>Hamilton DF, Lane JV, Gaston P, Patton JT, Macdonald D, Simpson AH, Howie CR. What determines patient satisfaction with surgery? A prospective cohort study of 4709 patients following total joint replacement. BMJ Open. 2013 Apr 9;3(4):e002525. doi: 10.1136/bmjopen-2012-002525. Print 2013.</citation>
    <PMID>23575998</PMID>
  </reference>
  <reference>
    <citation>Pihl K, Roos EM, Nissen N, JoRgensen U, Schjerning J, Thorlund JB. Over-optimistic patient expectations of recovery and leisure activities after arthroscopic meniscus surgery. Acta Orthop. 2016 Dec;87(6):615-621. doi: 10.1080/17453674.2016.1228411. Epub 2016 Sep 13.</citation>
    <PMID>27622598</PMID>
  </reference>
  <reference>
    <citation>Waljee J, McGlinn EP, Sears ED, Chung KC. Patient expectations and patient-reported outcomes in surgery: a systematic review. Surgery. 2014 May;155(5):799-808. doi: 10.1016/j.surg.2013.12.015. Epub 2013 Dec 16.</citation>
    <PMID>24787107</PMID>
  </reference>
  <reference>
    <citation>Aversa M, Chowdhury NA, Tomlinson G, Singer LG. Preoperative expectations for health-related quality of life after lung transplant. Clin Transplant. 2018 Oct;32(10):e13394. doi: 10.1111/ctr.13394. Epub 2018 Sep 25.</citation>
    <PMID>30160803</PMID>
  </reference>
  <reference>
    <citation>Katz S, Downs TD, Cash HR, Grotz RC. Progress in development of the index of ADL. Gerontologist. 1970 Spring;10(1):20-30. doi: 10.1093/geront/10.1_part_1.20. No abstract available.</citation>
    <PMID>5420677</PMID>
  </reference>
  <reference>
    <citation>Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.</citation>
    <PMID>5349366</PMID>
  </reference>
  <reference>
    <citation>Charney DS. Psychobiological mechanisms of resilience and vulnerability: implications for successful adaptation to extreme stress. Am J Psychiatry. 2004 Feb;161(2):195-216. doi: 10.1176/appi.ajp.161.2.195.</citation>
    <PMID>14754765</PMID>
  </reference>
  <reference>
    <citation>Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.</citation>
    <PMID>12964174</PMID>
  </reference>
  <reference>
    <citation>Cosco TD, Kaushal A, Richards M, Kuh D, Stafford M. Resilience measurement in later life: a systematic review and psychometric analysis. Health Qual Life Outcomes. 2016 Jan 28;14:16. doi: 10.1186/s12955-016-0418-6.</citation>
    <PMID>26821587</PMID>
  </reference>
  <reference>
    <citation>Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.</citation>
    <PMID>15085902</PMID>
  </reference>
  <reference>
    <citation>Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.</citation>
    <PMID>2280326</PMID>
  </reference>
  <reference>
    <citation>Shumaker SC, Frazier SK, Moser DK, Chung ML. Psychometric Properties of the Multidimensional Scale of Perceived Social Support in Patients With Heart Failure. J Nurs Meas. 2017 Apr 1;25(1):90-102. doi: 10.1891/1061-3749.25.1.90.</citation>
    <PMID>28395702</PMID>
  </reference>
  <reference>
    <citation>Hoffmann TC, Del Mar C. Patients' expectations of the benefits and harms of treatments, screening, and tests: a systematic review. JAMA Intern Med. 2015 Feb;175(2):274-86. doi: 10.1001/jamainternmed.2014.6016.</citation>
    <PMID>25531451</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>December 14, 2021</last_update_submitted>
  <last_update_submitted_qc>December 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03797313
org study id: IRB00197235
secondary id: 00181895
secondary id: K01HL141637-01
nct id: NCT03797313
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This is an observational cohort study of the association between patient expectations for
      functional recovery and quality of life among acute respiratory failure survivors 6 months
      after hospital discharge.
This study will enroll adults who are diagnosed with acute respiratory failure during an ICU
      admission and discharged from the ICU alive. All participants will receive usual clinical
      care. Participant expectations for functional recovery will be assessed before hospital
      discharge via a standardized questionnaire containing a visual analogue scale and questions
      about expected ability and importance of being able to perform activities of daily living and
      instrumental activities of daily living in 6 months. At 6 months, participants will be
      re-contacted by phone. Study staff will administer questionnaires to assess whether patient
      expectations have been met. Quality of life will be assessed using the WHOQOL-BREF and the
      EQ-5D-VAS.
observational model: Cohort
time perspective: Prospective
measure: Quality of life measured using the World Health Organization Quality of Life-BREF instrument (WHOQOL-BREF) after hospital discharge
time frame: 6 months after hospital discharge
description: WHOQOL-BREF is a measure of overall quality of life that evaluates satisfaction with important aspects of life rather than of health. The instrument contains 26 items across 4 domains, and requires approximately 5 minutes to administer over the phone. The 26 items in the WHOQOL-BREF are scored in four domains: physical, psychological, social relations, and environment, with between 3 and 8 items in each domain and two "benchmark" items addressing overall QoL. Transforming the raw scores results in a domain score between 0 - 100, enabling comparisons between domains with different numbers of items. Higher scores indicate greater participant satisfaction with their quality of life and lower scores indicate worse satisfaction with quality of life.
measure: Patient expectation error measure using EQ-5D VAS
time frame: 6 months after hospital discharge
description: A secondary analysis will estimate patient expectation error, defined as the difference between the health-related quality of life score expected at hospital discharge and the actual health related quality of life score assessed using the EQ-5D VAS 6 months after hospital discharge. The EQ-5D VAS ranges from 0 to 100 with 0 representing the worst imaginable health state and 100 representing the best imaginable health state.
arm group label: Patient's expectations met at Hospital discharge
description: ARF survivors whose expectations for recovery at hospital discharge are fully met 6 months later.
arm group label: Patient's with unmet expectations at Hospital Discharge
description: ARF survivors whose expectations for recovery at hospital discharge are not fully met 6 months later.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alison Turnbull
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Rubenfeld GD, Caldwell E, Peabody E, Weaver J, Martin DP, Neff M, Stern EJ, Hudson LD. Incidence and outcomes of acute lung injury. N Engl J Med. 2005 Oct 20;353(16):1685-93. doi: 10.1056/NEJMoa050333.
PMID: 16236739
citation: Cox CE, Docherty SL, Brandon DH, Whaley C, Attix DK, Clay AS, Dore DV, Hough CL, White DB, Tulsky JA. Surviving critical illness: acute respiratory distress syndrome as experienced by patients and their caregivers. Crit Care Med. 2009 Oct;37(10):2702-8. doi: 10.1097/CCM.0b013e3181b6f64a.
PMID: 19865004
citation: Spragg RG, Bernard GR, Checkley W, Curtis JR, Gajic O, Guyatt G, Hall J, Israel E, Jain M, Needham DM, Randolph AG, Rubenfeld GD, Schoenfeld D, Thompson BT, Ware LB, Young D, Harabin AL. Beyond mortality: future clinical research in acute lung injury. Am J Respir Crit Care Med. 2010 May 15;181(10):1121-7. doi: 10.1164/rccm.201001-0024WS. Epub 2010 Mar 11.
PMID: 20224063
citation: Zambon M, Vincent JL. Mortality rates for patients with acute lung injury/ARDS have decreased over time. Chest. 2008 May;133(5):1120-7. doi: 10.1378/chest.07-2134. Epub 2008 Feb 8.
PMID: 18263687
citation: Phua J, Badia JR, Adhikari NK, Friedrich JO, Fowler RA, Singh JM, Scales DC, Stather DR, Li A, Jones A, Gattas DJ, Hallett D, Tomlinson G, Stewart TE, Ferguson ND. Has mortality from acute respiratory distress syndrome decreased over time?: A systematic review. Am J Respir Crit Care Med. 2009 Feb 1;179(3):220-7. doi: 10.1164/rccm.200805-722OC. Epub 2008 Nov 14.
PMID: 19011152
citation: Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.
PMID: 21946660
citation: Hopkins RO, Suchyta MR, Kamdar BB, Darowski E, Jackson JC, Needham DM. Instrumental Activities of Daily Living after Critical Illness: A Systematic Review. Ann Am Thorac Soc. 2017 Aug;14(8):1332-1343. doi: 10.1513/AnnalsATS.201701-059SR.
PMID: 28463657
citation: Kamdar BB, Huang M, Dinglas VD, Colantuoni E, von Wachter TM, Hopkins RO, Needham DM; National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome Network. Joblessness and Lost Earnings after Acute Respiratory Distress Syndrome in a 1-Year National Multicenter Study. Am J Respir Crit Care Med. 2017 Oct 15;196(8):1012-1020. doi: 10.1164/rccm.201611-2327OC.
PMID: 28448162
citation: Lieu TA, Au D, Krishnan JA, Moss M, Selker H, Harabin A, Taggart V, Connors A; Comparative Effectiveness Research in Lung Diseases Workshop Panel. Comparative effectiveness research in lung diseases and sleep disorders: recommendations from the National Heart, Lung, and Blood Institute workshop. Am J Respir Crit Care Med. 2011 Oct 1;184(7):848-56. doi: 10.1164/rccm.201104-0634WS.
PMID: 21965016
citation: Carson SS, Goss CH, Patel SR, Anzueto A, Au DH, Elborn S, Gerald JK, Gerald LB, Kahn JM, Malhotra A, Mularski RA, Riekert KA, Rubenfeld GD, Weaver TE, Krishnan JA; American Thoracic Society Comparative Effectiveness Research Working Group. An official American Thoracic Society research statement: comparative effectiveness research in pulmonary, critical care, and sleep medicine. Am J Respir Crit Care Med. 2013 Nov 15;188(10):1253-61. doi: 10.1164/rccm.201310-1790ST.
PMID: 24160906
citation: Cox CE, Martinu T, Sathy SJ, Clay AS, Chia J, Gray AL, Olsen MK, Govert JA, Carson SS, Tulsky JA. Expectations and outcomes of prolonged mechanical ventilation. Crit Care Med. 2009 Nov;37(11):2888-94; quiz 2904. doi: 10.1097/CCM.0b013e3181ab86ed.
PMID: 19770733
citation: Lamas DJ, Owens RL, Nace RN, Massaro AF, Pertsch NJ, Gass J, Bernacki RE, Block SD. Opening the Door: The Experience of Chronic Critical Illness in a Long-Term Acute Care Hospital. Crit Care Med. 2017 Apr;45(4):e357-e362. doi: 10.1097/CCM.0000000000002094.
PMID: 27632675
citation: Turnbull AE, Davis WE, Needham DM, White DB, Eakin MN. Intensivist-reported Facilitators and Barriers to Discussing Post-Discharge Outcomes with Intensive Care Unit Surrogates. A Qualitative Study. Ann Am Thorac Soc. 2016 Sep;13(9):1546-52. doi: 10.1513/AnnalsATS.201603-212OC.
PMID: 27294981
citation: Thompson AG, Sunol R. Expectations as determinants of patient satisfaction: concepts, theory and evidence. Int J Qual Health Care. 1995 Jun;7(2):127-41. doi: 10.1093/intqhc/7.2.127.
PMID: 7655809
citation: Gonzalez Saenz de Tejada M, Escobar A, Herrera C, Garcia L, Aizpuru F, Sarasqueta C. Patient expectations and health-related quality of life outcomes following total joint replacement. Value Health. 2010 Jun-Jul;13(4):447-54. doi: 10.1111/j.1524-4733.2009.00685.x. Epub 2010 Jan 15.
PMID: 20088892
citation: Soroceanu A, Ching A, Abdu W, McGuire K. Relationship between preoperative expectations, satisfaction, and functional outcomes in patients undergoing lumbar and cervical spine surgery: a multicenter study. Spine (Phila Pa 1976). 2012 Jan 15;37(2):E103-8. doi: 10.1097/BRS.0b013e3182245c1f.
PMID: 21629159
citation: Hamilton DF, Lane JV, Gaston P, Patton JT, Macdonald D, Simpson AH, Howie CR. What determines patient satisfaction with surgery? A prospective cohort study of 4709 patients following total joint replacement. BMJ Open. 2013 Apr 9;3(4):e002525. doi: 10.1136/bmjopen-2012-002525. Print 2013.
PMID: 23575998
citation: Pihl K, Roos EM, Nissen N, JoRgensen U, Schjerning J, Thorlund JB. Over-optimistic patient expectations of recovery and leisure activities after arthroscopic meniscus surgery. Acta Orthop. 2016 Dec;87(6):615-621. doi: 10.1080/17453674.2016.1228411. Epub 2016 Sep 13.
PMID: 27622598
citation: Waljee J, McGlinn EP, Sears ED, Chung KC. Patient expectations and patient-reported outcomes in surgery: a systematic review. Surgery. 2014 May;155(5):799-808. doi: 10.1016/j.surg.2013.12.015. Epub 2013 Dec 16.
PMID: 24787107
citation: Aversa M, Chowdhury NA, Tomlinson G, Singer LG. Preoperative expectations for health-related quality of life after lung transplant. Clin Transplant. 2018 Oct;32(10):e13394. doi: 10.1111/ctr.13394. Epub 2018 Sep 25.
PMID: 30160803
citation: Katz S, Downs TD, Cash HR, Grotz RC. Progress in development of the index of ADL. Gerontologist. 1970 Spring;10(1):20-30. doi: 10.1093/geront/10.1_part_1.20. No abstract available.
PMID: 5420677
citation: Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
PMID: 5349366
citation: Charney DS. Psychobiological mechanisms of resilience and vulnerability: implications for successful adaptation to extreme stress. Am J Psychiatry. 2004 Feb;161(2):195-216. doi: 10.1176/appi.ajp.161.2.195.
PMID: 14754765
citation: Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
PMID: 12964174
citation: Cosco TD, Kaushal A, Richards M, Kuh D, Stafford M. Resilience measurement in later life: a systematic review and psychometric analysis. Health Qual Life Outcomes. 2016 Jan 28;14:16. doi: 10.1186/s12955-016-0418-6.
PMID: 26821587
citation: Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
PMID: 15085902
citation: Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.
PMID: 2280326
citation: Shumaker SC, Frazier SK, Moser DK, Chung ML. Psychometric Properties of the Multidimensional Scale of Perceived Social Support in Patients With Heart Failure. J Nurs Meas. 2017 Apr 1;25(1):90-102. doi: 10.1891/1061-3749.25.1.90.
PMID: 28395702
citation: Hoffmann TC, Del Mar C. Patients' expectations of the benefits and harms of treatments, screening, and tests: a systematic review. JAMA Intern Med. 2015 Feb;175(2):274-86. doi: 10.1001/jamainternmed.2014.6016.
PMID: 25531451
responsible party type: Sponsor
mesh term: Respiratory Insufficiency
mesh term: Respiratory Distress Syndrome
sharing ipd: Undecided