Health Related Quality of Life after Multiple Trauma in Adolescents

doi:10.21203/rs.2.22166/v1

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Health Related Quality of Life after Multiple Trauma in Adolescents

https://doi.org/10.21203/rs.2.22166/v1

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Purpose Trauma is still a major burden in global public health. In the past, multiple pieces of trauma research focused on mortality as an outcome parameter. The purpose of this study is to evaluate the global health-related quality of life (HRQoL) of adolescents after multiple trauma.

Methods We conducted a multicenter prospective registry-based study on patients aged 16-24 years who sustained a multiple trauma (ISS>16). Data acquisition was based on the trauma registry of the German Trauma Society (DGU). Additionally, the global HRQoL was measured using the EQ-5D score at 6, 12, and 24 months post trauma.

Results We identified 77 patients meeting the inclusion criteria. There were 65 male (84%) and 12 female (16%) patients. The average age at time of injury was 20.27 years (±2.34). The mean ISS was 26.4 (±10.58). Six months post multiple trauma, we found an EQ-5D index score of 0.85. The score improved after 12 and 24 months to 0.87. There was no significant correlation between the ISS of any body region and the EQ-5D index value at 6, 12, or 24 months.

Conclusions We found a limited HRQoL measured by an EQ-5D index score six months post multiple trauma. There was an improvement in HRQoL from 6 to 12 months and a stable condition between 12 and 24 months after trauma. Compared to normal values of healthy subjects, this still suggests an impairment of HRQoL after multiple trauma.

Pediatrics

Health Economics & Outcomes Research

Health services research

Management of polytrauma

Multiple trauma

Adolescent Polytrauma

Outcome research

Patient-reported outcome

Trauma register

Despite tremendous improvements in accident prevention, trauma still constitutes a major burden in global public health. A traumatic injury is the leading cause of death between the ages of 15–44 years. In the past, multiple trauma research focused on mortality as the main outcome parameter.¹ However, survival or death is a limited indicator for characterization of the consequences of such an event. Research that focuses in morbidity instead of mortality provides more in-depth insight on the consequences on multiple trauma, however, it is a lot more demanding in that it requires follow up with patients over an extended period of time.² Contemporary research on health-related quality of life (HRQoL) is mainly patient-centered.³ Multidimensional scoring systems like the EQ-5D are validated and well established. The standard values of healthy subjects are available for different age groups.⁴ Despite demographic changes in industrial countries, the younger generation is in the spotlight in this field because they generally have a higher life expectancy and a higher functional demand. These patients are of extraordinary interest especially from a socio-economic point of view.

During the period of adolescence, the transition from child to adulthood contains significant physical and psychological transformation.⁵ Adolescence is characterized by an increased risk propensity, occasional emotional instability and a high level of physical demand.⁶ The question remains what consequences multiple trauma has on adolescent quality of life. Moreover, it is unclear whether a certain injury pattern like cranio-cerebral injuries (CCI) or other injuries like extremity injuries have a higher impact on impairment of HRQoL in multiply injured adolescents. Due to an increased risk of injury and higher functional expectations, this patient population warrants further research.

The purpose of this study is to evaluate the global HRQoL of adolescents after multiple trauma and to correlate injury patterns and the HRQoL to identify risk factors for and impairment of HRQoL after multiple trauma in adolescents.

We conducted a multicenter prospective registry-based study on patients aged 16-24 years who sustained multiple trauma with an Injury Severity Score greater or equal 16 (ISS) from 03/2012 to 02/2014. The study was executed within the East Bavarian trauma network (TNO) consisting of 25 hospitals of basic care (n=15), standard care (n=8), and two maximum care facilities. The mainly rural area of the TNO consists of about 20,000 square kilometers and has approximately 2.3 million inhabitants. The TNO was founded in 2007 and has proven to be an effective network to improve patient care of the severely injured.⁷ All 25 hospitals of the TNO network participate in the trauma registry of the German Trauma Society (DGU), which was the basis for this prospective multicenter study.

The study was approved by the Ethics Committee of the University of Regensburg (Institutional Review Board Number 10-101-0077), is funded by a grant from the German Federal Ministry of Education and Research (reference number 01GY1153), and is registered in the data base of the German Network of Health Services Research (reference number VfD_Polyqualy_12_001978, date 10.Jan.2013), and in the German Clinical Trials Register (DRKS00010039, 18. Feb. 2016).

Exclusion criteria were an age below 16 or over 24 years, an ISS below 16, care outside the TNO, or missing data. All data was collected prospectively. Particular efforts were made to assure excellent quality of recorded data and monitoring the process quality of care. Details of the study protocol are published by Koller et al.⁸

During the study period, a total number of 1143 multiple trauma patients was treated within the TNO. 215 patients were excluded due to secondary admission (n=112), a transfer within the first 48 hours after trauma (n=101), or missing data of the RISC II (n=3). Of the remaining 927 patients, there were 77 patients meeting the criteria of adolescence (age 16-24 years) and a EQ 5-D global quality of life questionnaire at 6, 12, and 24 months post trauma (Figure 1).

Data acquisition was based on the Trauma registry of the German Trauma Society (DGU). The web-based registry contains 130 single items per patient. For initial evaluation of patients, the following scoring scales were used:

- Glasgow Coma Scale (GCS)

- Glasgow Outcome Scale (GOS)

- Injury Severity Score (ISS)

- Abbreviated Injury Scale (AIS) for each body region

- Revised Injury Severity Classification II (RISC II)

- Standardized Mortality Ratio (SMR)

Additionally, the global HRQoL was measured using the EQ-5D score at 6, 12, and 24 months post trauma. The EQ 5-D is a global quality of life questionnaire consisting of a 5-item assessment of the health status regarding mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.⁴ The second part of the EQ 5-D consists of a 100 mm global health visual analogue scale (EQ-VAS) ranging from 0-100 points and concerning the patient’s assessment of their current global health status. The EQ 5-D has been adapted to German and has been validated for a number of health compromising conditions.⁹

Another hypothesis was that certain injury patterns might cause greater limitations of outcome than others. There is evidence that the consequences of CCI can be compensated a lot better in younger patients, whereas musculo-skeletal limitations might have a greater impact on the HRQoL. Therefore, we intended to investigate the 20% of patients with the lowest and highest EQ-5D score in more detail. Our hypothesis was that within these subgroups, there would be a correlation between the EQ-5D and the severity of injury measured by the ISS of each body region.

To evaluate whether an injury in a specific body region would have greater impact on HRQoL, we correlated the ISS of each region (head and neck, facial, thorax, abdomen, extremities and external) to the EQ-5D index value at 6, 12, and 24 months.

Statistics

Statistical analysis was performed using the software package SPSS (Version 25, SPSS Inc, Chicago, Illinois). For comparison of mean values, we used the independent t-test. For analysis of intra-individual parameters (paired data) we used the Wilcoxon signed-rank test. Unless otherwise stated, descriptive data is given as mean ± standard deviation. The level of significance was set at p < 0.05 for all tests.

For evaluation of HRQoL among adolescent multiple trauma patients, we identified 77 patients who meet the age criterion of adolescence (16-24 years) for whom a complete data set regarding the DGU trauma registry data set and an evaluation of the EQ-5D was available. Among these 77 patients meeting the inclusion criteria, there were 65 male (84%) and 12 female (16%) patients. The mean age at time of injury was 20.27 years (±2.34). The mean ISS was 26.4 (±10.58) (Table 1). Regarding the mechanism of injury, the majority of patients sustained a high-velocity trauma associated to road traffic (Figure 2). There were 71/77 (96%) patients who sustained a blunt trauma and only 3/71 (4%) with a penetrating injury. The majority of patients suffered a blunt injury to the thorax (50/77, 78%). 60% of patients sustained a CCI and half of the patients an abdominal trauma.

The median stay on ICU was recorded as 7 days [IQR 2-12]. The median duration of intubation was 1 day [IQR 0-164]. 30 patients required emergency operation subsequent to primary survey in the resuscitation room. 3 patients were craniotomized, 10 patients laparotomized and 13 patients required stabilizing interventions of extremities or pelvis. No patient died within the first 24 months after multiple trauma, therefore, the mortality rate was 0%.

Measurement of HRQoL revealed a slight improvement of global quality of life from 6 months to 12 months and remained stable at 24 months post trauma measured by an EQ-5D index score (Table 2). Concordant with the EQ-5D index value, the global health visual analogue scale (EQ-VAS) showed a mean improvement from 6 to 12 months post trauma of ten points and remained stable to month 24 (Table 2). After 12 and 24 months the mean EQ-5D values are close to the same level as the healthy control subjects of the same age group (0.95).¹²

Patients with a functional capacity index (FCI) of 1 (worst possible state) showed a significant worse quality of life than patients with a FCI>1. Likewise, a higher RISC2 score and a higher ISS showed worse quality of life. Nevertheless, none of them showed a significant interaction with time. I.e. change of quality of life is statistically independent of the severity of the injury. (Tables 3,4).

There was also no significant correlation between the ISS of any body region and the EQ-5D index value at 6, 12, or 24 months.

The relationship between ISS head and neck and the evolution of EQ-5D index value is shown in Figure 3. Except for those suffering from critical CCI injuries (AIS 5), all patients improved from 6 to 12 months post trauma.

To our knowledge, this is the first study investigating global HRQoL after multiple trauma in adolescents. Compared to normal values of healthy subjects, we found an impairment of HRQoL six months post trauma and an increase of HRQoL from 6 to 12 months post trauma. We found no correlation between injury pattern and HRQoL.

The importance of a functional impairment increases with mean life expectancy of the patient. Therefore, young, physically active patients are especially endangered by posttraumatic limitations.⁶ Adolescence is the transition from childhood to adulthood. Since adolescence spans only a limited period of time and there is no absolute definition of its duration, these patients are generally under-researched.¹⁰ There is no general definition of adolescence. The WHO defines adolescence as subjects aged 10–20 years. The Anglo-American definition is related to the expression “teenager” from 13–19 years of age. However, the physical and psychological transition is not limited to the age of under twenty. In Europe, the period between 16–24 years of age is therefore considered most accurate as a description of adolescence.¹¹ In this study, we chose the interval of 16–24 years of age, because this is the age group of patients with a high-risk propensity and a high level of physical demand being particularly threatened by posttraumatic disorders.^{6 12} The lack of proper definition has led to a neglect of research in this very demanding and energetic population group.

Trauma can be a life-threatening event and if the patient survives, trauma might lead to persistent functional limitations. Outcome after severe injury is a main issue in literature. Most studies focus on mortality as a primary outcome parameter.¹ The mortality of our adolescent cohort was 0% compared to 19.4% of the total study population including adult patients.¹⁴

Since improvements in preclinical and clinical treatment led to a decreasing rate of mortality, the question of quality of life after severe trauma gains importance.¹⁵ Especially in cohort of younger patients, the functional impairment after injury might be of great interest, since they have an entire life to build. Facing the socio-economic impact, morbidity is evolving as a critical outcome parameter. ¹⁶ The main focus of this study is the evaluation of posttraumatic HRQoL in adolescent multiple trauma patients. We used the EQ-5D HRQoL outcome score. This is a well-established, patient-reported outcome measurement (PROM) tool.⁴ It has been adapted and validated in German. Normal values for the EQ-5D and the EQ-VAS are available for different age groups.⁹ The global HRQoL was measured using the EQ-5D score at 6, 12, and 24 months post trauma.

We found a limited HRQoL measured by an EQ-5D index score of 0.85 six months post trauma. We recorded an increase of HRQoL from 6 to 12 months post trauma and a steady state from 12 to 24 months. Thus, compared to normal values of healthy subjects, this still means an impairment of HRQoL.⁹ This is not an unexpected result. What is concordant with other studies is a distinct improvement of global quality of life from 6 months to 12 and no relevant change from 12 to 24 months post trauma: According to literature, at 12 months after trauma a high percentage of adult patients show a full recovery of their physical injuries.^{17 18}

After 24 months after trauma, a stable situation of disabilities is likely.¹⁸ The results of the EQ-VAS in our study also reflect this tendency towards improvement within the first year after trauma.

It is worth noting that the difference between the study population (0.87) and normal values of healthy subjects (0.95) is not as big as in other studies investigating posttraumatic condition after multiple trauma in adults.¹⁹ For children, studies already described this phenomenon of accelerated recovery and a correlation of age and recovery from injury.²² This further stresses the importance of developing a clear definition of adolescence to elaborate the intricacies in the interim period between infancy and adulthood.

Another important issue of this study was to correlate the HRQoL result with different injury patterns. The Injury Severity Scale (ISS) is a scoring system with a clear definition which grades the severity of injuries in defined anatomical regions using the Abbreviated Injury Scale (AIS). A severe trauma can be predicted when the ISS is greater or equal to 16.

HRQoL by contrast has many different definitions in literature.²³ It can be defined as “how well a person functions in their life and his or her perceived wellbeing in physical, mental, and social domains of health”^{24 25} or as "aspects of self-perceived wellbeing that are related to or affected by the presence of disease or treatment.”²⁶ Other definitions conclude that “quality of life is an all inclusive concept incorporating all factors that impact upon an individual’s life. Health-related quality of life includes only those factors that are part of an individual’s health.”²⁷ HRQoL can also refer to the “values assigned to different health states;" these values are used to calculate the benefits of health technologies.²⁸

There is ongoing discussion about the correlation between ISS and health related quality of life in general:

A prospective Norwegian study assessing HRQOL of 242 adults with a mean ISS of 10 during the first year after trauma also aimed to identify predictors of HRQOL. They found that an optimistic disposition, lower age, employment, good general health and a lower ISS score were factors of good HRQOL. Interestingly, better physical functioning was predicted by having a head injury as the most severe injury vs spine or extremitiy injuries.²⁹

Gunning et al. retrospectively evaluated 1870 adults after severe trauma and identified age, ICU admission, probability of survival, injury type and severe injury to the head or extremities as predictors for worse HRQOL. The severity of an injury measured with AIS did not show a high association with HRQOL. Only severe injury to the extremities and head showed a relevant influence on the HRQOL.³⁰

The relationship between injury severity and HRQOL was investigated in several studies. In 2012, Martin-Herz et al. published a review of literature investigating HRQOL following general traumatic injury in patients under 18 years of age. The review’s conclusion was ambivalent, with some studies finding reductions in HRQOL with higher ISS, ^{31 32} while other studies could not detect any correlation.^{33 34}

A focus on the type of injury as investigated by Sturms et al. showed that a lower extremity fracture of children was associated with significantly worse HRQOL than either an upper extremity injury or no extremity fracture.³⁵ Hu et al also postulated that functional impairment and recovery in children are related more to the body parts involved than to the ISS.³⁶ We also compared each ISS body region to the EQ-5D results, but did not find any significant difference. The subgroup analysis of the 20% best and worst results also did not reveal any significant difference.

Health related quality of life has also been shown to be associated with gender, age, length of hospitalization, low education and comorbidities.^{37 38 39}

We did not find any correlation as such within our cohort.

Moreover, social support systems and indicators of participation (social integration, mobility, and community and vocational activity) are found to be better indicators to good outcome and quality of life than the measurement of injury severity.⁴⁰

For that matter, adolescent patients do have an advantage over adults because of their generally more sound social environment. Nevertheless, determining the health related quality of life in adolescent severe trauma patients is crucial for identifying those in need of more care and rehabilitation. Those results might lead to preventative measures which could help decrease posttraumatic disabilities. In order to further enhance the significance of HRQoL as an Indicator of adolescent trauma and for trauma center performance, there should be a clear definition of adolescence, a consensus of the ideal timing for the measurement and about the measurement instruments, in order to standardize studies for reliable and comparable results.

Limitations

Our study has some limitations. The main issue is the limited number of cases. Adolescent multiple trauma is a rare condition. Even in a large registry-based study with participation of all relevant hospitals in a specific area it was not possible to enroll more than 77 adolescent multiple trauma patients to the study. Another limitation is that we cannot provide clinical follow-up data on our patients to correlate the HRQoL with the clinical condition. With a total number of cases in this trial of over 1000 patients, this effort would not have been possible. However, the main strength of this study is its prospective multicenter registry-based design. Within the TNO, we were able to include all potential cases and establish a standardized study protocol to achieve excellent data quality.

This is the first study to report on HRQoL after adolescent multiple trauma. We found a limited HRQoL measured by an EQ-5D index score of 0.85 six months post trauma. We recorded an increase of HRQoL from 6 to 12 months post trauma and a steady state from 12 to 24 months. Thus, compared to normal values of healthy subjects, this still means an impairment of HRQoL. Further studies into identification of potential risk factors for a limited HRQoL are recommended.

AIS - Abbreviated Injury Scale

CCI – cranio-cerebral injury

GCS - Glasgow Coma Scale

GOS - Glasgow Outcome Scale

HRQoL – health-related quality of life

ICU – Intensive care unit

ISS – Injury Severity Score

PROM – Patient-reported outcome measurement

RISC II - Revised Injury Severity Classification II

SMR - Standardized Mortality Ratio

Ethical Approval and Consent to participate

The study was approved by the Ethics Committee of the University of Regensburg (Institutional Review Board Number 10-101-0077) and is registered in the data base of the German Network of Health Services Research (reference number VfD_Polyqualy_12_001978, date 10.Jan.2013), and in the German Clinical Trials Register (DRKS00010039, 18. Feb. 2016). Informed consent to participate in the study was obtained from all individual participants included in the study.

Consent for publication

Informed consent was obtained from all individual study participants to publish data collected from the participants. All authors gave consent for publication.

Availability of supporting data

The dataset generated during this study will not be publicly available to protect the participants’ anonymity.

Competing interests

The authors declare that they have no competing interests.

Funding

The study is funded by a grant from the German Federal Ministry of Education and Research (reference number 01GY1153),

Authors' contributions

VF carried out data interpretation, performed literature research and drafted the manuscript. AE, MR, VA, JW, SL and FZ were involved in the design and correction work. FB was significantly involved in design, coordination and draft of the manuscript. All authors red and approved the final version of the manuscript.

Acknowledgements

The authors would like to express their appreciation to all participants of this study for their cooperation.

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Table 1: Baseline characteristics of the study population

Female/male, n (%)	12 (16%) / 65 (84%)
Age (years), mean (SD)	20.27 (2.34)
Injury severity score, mean (SD)	26.4 (10.58)
Mechanical ventilation (days), median [IQR]	1 [0, 164]
Intensive care unit stay (days) , median [IQR]	7 [2, 12]

Table 2: Measurement of HRQoL

	6 months	12 months	24 months	p-value
EQ-5D index score	0.82 (0.77-0.88)	0.86 (0.81-0.91)	0.86 (0.81-0.92)	0.138
EQ-5D VAS*	69 (64-74)	79 (74-85)	79 (74-85)	<0.001

Data show estimated means (95%-confidence interval) adjusted by RISC2 and functional capacity index by using linear mixed models; *Question: “We would like to know how good or bad your health is TODAY?” on a scale from 0-100

Table 3: Correlation of severity of injury and HRQoL

	p-value
Index value	Main effect	Time effect	Interaction	Effect estimate
FCI (1 vs. >1)	0.015	0.824	0.511	Table 3a
RISC2	0.001	0.167	0.768	-0.04 (per 10 units)
ISS	0.01	0.378	0.729	-0.06 (per 10 units)
VAS
FCI (1 vs. >1)	0.121	<0.001	0.903	Table 3a
RISC2	0.003	<0.001	0.957	-3.5 (per 10 units)
ISS	0.007	0.095	0.970	-5.3 (per 10 units)

Table 4: Effect estimates

	6 months	12 months	24 months
Index value
FCI=1	0.72 (0.56-0.87)	0.72 (0.58-0.87)	0.68 (0.54-0.82)
FCI>1	0.84 (0.80-0.89)	0.88 (0.83-0.93)	0.89 (0.84-0.94)
VAS
FCI=1	59 (45-74)	71 (56-85)	72 (57-86)
FCI>1	71 (66-76)	82 (77-87)	81 (76-86)

Data show estimated means (95%-confidence interval)

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Health Related Quality of Life after Multiple Trauma in Adolescents

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