Quality of Life Splenic injury splenic laceration
Conditions
Interventions
None listed
Sponsors
Sint Elisabeth Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients: - With splenic injury after blunt abdominal trauma - Treated with non-operative management, splenic artery embolization or splenectomy - Treatment took place in the period from May 2016 to December 2018 at one of the eleven selected hospitals - 18 years or older
Exclusion criteria
Exclusion criteria: - Insufficient knowledge of the Dutch language - Patiënts who died are (of course) excluded for questionnaires and follow-up MRI, not for clinical outcomes, Exclusion for MRI only: - Patients treated with splenic artery embolization: patiënts who do not want to or are not able to undergo an MRI scan of the abdomen (for example pregnant women or other contraindications for MRI) (Patients excluded for MRI still need to fill out the questionnaires. Also, their clinical outcomes will be processed in the database.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (II) PROSPECTIVE PRIMARY Quality of life is assessed with the generic 26-item World Health Organization Quality of Life-Bref (WHOQOL-Bref) [14] at 1 week, 1 month, 3 months, 6 months and 1 year follow-up. This measure assesses four domains (Physical health, Psychological health, Social relationships, and Environment) and a general facet *Overall QOL and general health*. The short-form (12) health survey is a shorter version of the SF-36, which is used to evaluate individual patients health status, researching the cost-effectiveness of a treatment and monitoring and comparing disease burden. iMCQ (iMTA Medical Consumption Questionnaire): The iMTA Medical Consumption Questionnaire (iMCQ), is a generic non disease specific instrument for measuring (direct) medical costs. The instrument is a standardized self-reported questionnaire. The iMCQ includes questions related to frequently occurring contacts with health care providers and can be complemented with extra questions that are relevant for specific study populations. A manual is available for a structured use of the questionnaire. Cost-prices be applied to the obtained healthcare utilization by the iMCQ by using the Dutch manual for cost-analyses that is written by iMTA on behalves of Zorginstituut Nederland (former CVZ). The iMCQ can be combined with the iMTA Productivity Cost Questionnaire (iPCQ). With the iPCQ indirect costs can be measured in addition to the direct costs as measured by the iMCQ. iPCQ (iMTA Productivity Cost Questionnaire): The impact of disease on the ability of a person to perform work should be part of an economic evaluation when a societal perspective is applied. A manual is developed containing information on the modular structure of the iPCQ and its scoring- and valuation methods that are used for the cost calculations. The iPCQ is a generic non-disease specific questionnaire and is applicable to national and international studies. Currently a Dutch version vers | — |
Secondary
| Measure | Time frame |
|---|---|
| (II) PROSPECTIVE SECONDARY Furthermore the three treatments will be compared in terms of clinical outcomes, recovery related outcomes and cost outcomes. Also imaging outcomes will be investigated in the SAE group, thereby identifying morphological (versus immunological) aspects of the spleen after endovascular treatment. The following endpoints apply to each of the outcomes: - Clinical: complications during and/or after treatment; failure rate (technical, clinical); any re-intervention or additional therapy - Recovery related: hospital stay (days); return to daily activities - Cost: cost-utility analysis between SAE and splenectomy - Imaging: how does the spleen morphologically look like, in patients who underwent embolization treatment of the splenic artery in case of traumatic splenic injury? Splenic morpholical characteristics such as: volume; necrosis; splenosis; calcifications; chronic infarction morphology The cost effectiveness of SAE compared to splenectomy will be assessed using a Markov modeling approach taking into account uncertainty and using all available data. The effectiveness will be expressed in the most common outcome measure the Quality Adjusted Life year (QALY). The costs will be estimated from a societal perspective. For the cost-effectiveness study, data on quality of life, survival and costs are needed. - Quality of life will be calculated by the SF-12 - Survival will be derived from international clinical literature - Costs will be divided in direct medical costs and the costs due to productivity losses from a societal perspective. Costs are derived by multiplying the (health care) utilization or productivity loss by the reference price. - Costs will be estimated according to the Dutch Manual for Costing in Economic Evaluations, update 2010 (Hakkaart-van Roijen, Tan& Bouwmans 2010). - Health care utilization and production losses will be derived from various sources: o questionnaires concerning patientÕs healt | — |
Countries
Netherlands
Outcome results
None listed