Quality of Life and Clinical Outcome After Traumatic Spleen Injury (SPLENIQ Study): Protocol for an Observational Retrospective and Prospective Cohort Study

Quality of Life and Clinical Outcome After Traumatic Spleen Injury (SPLENIQ Study): Protocol for an Observational Retrospective and Prospective Cohort Study

Little is known about the effect of a splenic rupture on the quality of life (QOL) of patients, although the spleen is one of the most frequently injured organs in blunt abdominal trauma. It is essential to obtain more knowledge about QOL after traumatic spleen injury so that this can be taken into...

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Bibliographic Details
Published in:JMIR research protocols Vol. 8; no. 5; p. e12391
Main Authors: Raaijmakers, Claudia Pam, Lohle, Paul Nm, Lodder, Paul, de Vries, Jolanda
Format: Journal Article
Language:English
Published: Canada JMIR Publications 01-05-2019
Subjects:
Abdomen
Clinical outcomes
Cohort analysis
Cost analysis
Embolization
Hemodynamics
Magnetic resonance imaging
Mortality
Observational studies
Patients
Power
Protocol
Quality of life
Questionnaires
Spleen
Success
Surgery
Trauma
Trauma care
Trauma centers
United States > US
splenic artery embolization
trauma
magnetic resonance imaging
embolization
spleen
SAE
injury
quality of life
QOL
observational study
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Summary:Little is known about the effect of a splenic rupture on the quality of life (QOL) of patients, although the spleen is one of the most frequently injured organs in blunt abdominal trauma. It is essential to obtain more knowledge about QOL after traumatic spleen injury so that this can be taken into account when choosing treatment. The primary objective of the SPLENic Injury and Quality of life (SPLENIQ) study is to determine QOL after treatment for traumatic spleen injury. The secondary objective is to investigate clinical and imaging outcome in relation to QOL. A combination of a retrospective single-center and a prospective multicenter observational cohort study will be conducted. Patients in the retrospective study have had a splenic injury after blunt abdominal trauma and were admitted for treatment to the ETZ Hospital (Elisabeth-TweeSteden Ziekenhuis) in Tilburg between January 2005 and February 2017. Concerning the prospective cohort study, patients with splenic injury admitted to 1 of the 10 participating hospitals between March 2017 and December 2018 will be asked to participate. The follow-up period will be 1 year regarding QOL, clinical symptoms, and imaging. Patients in the retrospective study will complete 2 questionnaires: World Health Organization QOL assessment instrument-Bref (WHOQOL-Bref) and 12-Item Short-Form Health Survey (SF-12). Patients in the prospective study will complete 5 questionnaires at 1 week, 1 month, 3 months, 6 months, and 12 months after treatment: WHOQOL-Bref, SF-12, Euroqol 5-Dimensional 5-Level (EQ-5D-5L) questionnaire, Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ), and iMTA Medical Consumption Questionnaire (iMCQ). In both the retrospective and prospective study, patients treated with splenic artery embolization will undergo magnetic resonance imaging (MRI). The retrospective group will undergo MRI once, and the prospective group will undergo MRI 1 month and 1 year after treatment. Treatment of splenic injury depends on the severity of the splenic injury, the hemodynamic condition of the patient, and the hospital's or doctor's preference. This study is observational in nature without randomization. Concerning the retrospective data, multivariate analysis of covariance will be done. With regard to the prospective data, mixed linear modeling will be performed. This project was funded in April 2015 by ZonMw. The results of the retrospective study will be expected in March 2019. With regard to the prospective study, inclusion of patients was completed in December 2018 and data collection will be completed in December 2019. The first results will be expected in 2019. To our knowledge, this is the first study that examines QOL in patients with a traumatic spleen injury. The SPLENIQ study responds to the shortage of information about QOL after treatment for traumatic spleen injury and may result in the development of a patient-oriented protocol. ClinicalTrials.gov NCT03099798; https://clinicaltrials.gov/ct2/show/NCT03099798 (Archived by WebCite at http://www.webcitation.org/714ZKV6A0). DERR1-10.2196/12391.
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ISSN:1929-0748
1929-0748
DOI:10.2196/12391