DESIGN AND CONDUCT OF A MULTICENTER RANDOMIZED CLINICAL TRIAL ON THE IMPACT OF A POST-INTENSIVE CARE UNIT MULTIDISCIPLINARY FOLLOW-UP ON THE QUALITY OF LIFE (SUIVI-REA) (Preprint)

e16524 Background: Despite not being recommended by clinical guidelines, the tumor markers carcinoembryonic antigen (CEA), cancer antigen (CA)15-3, and CA 27.29 are used by some clinicians to screen for increased risk of breast cancer recurrence. Although additional research may be warranted to evaluate the benefits and risks of breast cancer tumor marker tests, clinical trials would likely need to involve thousands of women and would take many years to complete. We conducted an analysis to assess the societal value of a prospective randomized clinical trial (RCT) for breast tumor marker testing in routine follow-up of high-risk, stage II-III breast cancer survivors Methods: We used value of information techniques to assess the benefits of reducing uncertainty of using breast cancer tumor markers. We developed a decision-analytic model of biomarker testing in addition to standard surveillance at follow-up appointments every 3-6 months for five years. Expected value of sample information (EVSI) was assessed over a range of trial sizes and assumptions. Results: The overall value of research for an RCT involving 9,000 women was $166 million (EVSI). The value of improved information characterizing the survival impact of tumor markers was $81 million, quality-of-life $38 million, and test performance $95 million. Conclusions: Our analysis indicates that substantial societal value may be gained by conducting a clinical trial evaluating the use of breast cancer tumor markers. The most important aspects of the trial in our analysis were information gained on survival improvements as well as quality-of-life parameters associated with testing and test sensitivity and specificity. Our analysis indicates that smaller randomized trials, as well as adding quality of life instruments to existing trials, retrospective, and observational trials can also generate valuable and relevant information.

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Faculty Opinions recommendation of Health-related quality of life and return to work after critical illness in general intensive care unit patients: a 1-year follow-up study.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.4999956.4933054 ◽

2010 ◽

Author(s):

Gavin Joynt ◽

Gordon Choi

Keyword(s):

Quality Of Life ◽

Intensive Care Unit ◽

Intensive Care ◽

Critical Illness ◽

Health Related Quality ◽

Follow Up Study ◽

Related Quality ◽

Health Related

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The Impact of Medical Conditions on the Quality of Life of Survivors at Discharge From Intensive Care Unit

Medicina ◽

10.3390/medicina47050038 ◽

2011 ◽

Vol 47 (5) ◽

pp. 38 ◽

Cited By ~ 1

Author(s):

Andrius Klimašauskas ◽

Ieva Sereikė ◽

Aušra Klimašauskienė ◽

Gintautas Kėkštas ◽

Juozas Ivaškevičius

Keyword(s):

Quality Of Life ◽

Intensive Care Unit ◽

Intensive Care ◽

Organ System ◽

Therapeutic Interventions ◽

Prolonged Stay ◽

Role Physical ◽

Icu Discharge ◽

The Impact

Background and Objective. Impaired health-related quality of life (HRQOL) is one of the possible outcomes after discharge from an intensive care unit (ICU). Evaluation of patient health status on discharge from the ICU would help identify factors influencing changes in HRQOL after ICU discharge. The objective of the study was to identify whether health state on discharge from prolonged stay in the ICU has any influence on survivors’ HRQOL 6 months after intensive care. Material and Methods. A prospective study of patients with the prolonged length of stay (exceeding 7 days) in the ICU was conducted. The study covered the impact of organ system dysfunction (SOFA score), number of therapeutic interventions (TISS-28 score), and critical illness neuromuscular abnormalities (CINMA) on discharge from the ICU on HRQOL 6 months following ICU discharge. Results. In total, 137 patients were included in the study. The SOFA score on the last day in the ICU was 2.91 (SD, 1.57); the TISS-28 score on the last day in the ICU was 21.79 (SD, 4.53). Decreased physical functioning (PF) and role physical (RP) were identified. Circulatory impairment on discharge from the ICU had an impact on decreased PF (P=0.016), role physical (P=0.066), and role emotional (P=0.001). Patients with dysfunction in more than one organ system on ICU discharge had decreased role emotional (P=0.016). Severe CINMA was diagnosed in 18 patients. They had decreased PF (P=0.007) and RP (P=0.019). Patients with the TISS-28 score above or equal to 20 points showed lower HRQOL in the PF domain (P=0.077) and general health (P=0.038). Conclusions. HRQOL in patients with prolonged stay in the ICU is particularly impaired in the domains of physical functioning and role physical. It is associated with circulatory impairment, CINMA, and greater number of therapeutic interventions on discharge from the ICU.

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Intensive care units follow-up: a scoping review protocol

BMJ Open ◽

10.1136/bmjopen-2020-037725 ◽

2020 ◽

Vol 10 (11) ◽

pp. e037725

Author(s):

Danielle Prevedello ◽

Marco Fiore ◽

Jacques Creteur ◽

J C Preiser

Keyword(s):

Quality Of Life ◽

Intensive Care ◽

Scoping Review ◽

Grey Literature ◽

Icu Discharge ◽

Scoping Reviews ◽

The Impact

IntroductionIncreasing numbers of patients are surviving critical illness, leading to growing concern about the potential impact of the long-term consequences of intensive care on patients, families and society as a whole. These long-term effects are together known as postintensive care syndrome and their presence can be evaluated at intensive care unit (ICU) follow-up consultations. However, the services provided by these consultations vary across hospitals and units, in part because there is no validated standard model to evaluate patients and their quality of life after ICU discharge. We describe a protocol for a scoping review focusing on models of ICU follow-up and the impact of such strategies on improving patient quality of life.Methods and analysisIn this scoping review, we will search the literature systematically using electronic databases (MEDLINE - from database inception to June 15th 2020) and a grey literature search. We will involve stakeholders as recommended by the Joanna Briggs Institute approach developed by Peters et al. The research will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines.Ethics and disseminationThis study does not require ethics approval, because data will be obtained through a review of published primary studies. The results of our evaluation will be published in a peer-reviewed journal and will also be disseminated through presentations at national and international conferences.

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