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

Claudia Pam Raaijmakers, Paul Nm Lohle, Paul Lodder, Jolanda de Vries, Claudia Pam Raaijmakers, Paul Nm Lohle, Paul Lodder, Jolanda de Vries

Abstract

Background: 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.

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov NCT03099798; https://ichgcp.net/clinical-trials-registry/NCT03099798 (Archived by WebCite at http://www.webcitation.org/714ZKV6A0).

International registered report identifier (irrid): DERR1-10.2196/12391.

Keywords: QOL; SAE; embolization; injury; magnetic resonance imaging; observational study; quality of life; spleen; splenic artery embolization; trauma.

Conflict of interest statement

Conflicts of Interest: None declared.

©Claudia PAM Raaijmakers, Paul NM Lohle, Paul Lodder, Jolanda de Vries. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 26.04.2019.

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