Abstract
Introduction
Most studies of polytrauma examined highly mixed patient groups. The objective of the present study was to report the development of patient-reported quality of life (QOL), in a patient group with musculoskeletal polytrauma, excluding patients with major thoracic, abdominal, and brain injuries.
Materials and methods
The study design was a 1-year cohort follow-up study. Recordings of injury severity were measured with the ISS and NISS. Patient-reported QOL was measured with the questionnaires Eq5d-5L and SF-36 and compared to age-matched reference populations. Moreover, patients return to work status was measured. Data were collected prospectively at discharge, 3, 6, and 12 months.
Results
53 patients were included. The mean age was 42.3 years, ranging from 17 to 78 years. Twelve months after trauma admission, the mean Eq5d-5L index was 0.601 (95 % CI 0.546–0.657). A progressive increasing Eq5d-5L index and SF-36 PCS was observed between the discharge and the 12-month follow-up (p < 0.001). The development in QOL from 6 to 12 months almost shows identically scores. Throughout the study period, patients reported significant worse QOL compared with the established reference population. 32 % of patients have resumed earlier employment status at 1-year follow-up.
Conclusions
Throughout the 12-month observational period, patients reported worse QOL compared to the age-matched reference population. The development of QOL from 6- to 12-month time points almost showed identically scores with only little improvement. At the end of 1-year follow-up, 32 % of patients had resumed prior employment status.
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Introduction
Severely injured patients admitted as trauma patients following a high-energy trauma is reported with high risk of death and long-term morbidity [1–5]. Young men are predominant in this group of patients with the mode of injury often being a road traffic accident [2].
During the last decade, pre-hospital service and clinical emergency medicine have significantly improved survival of patients resulting in decreased mortality [4, 6]. As a consequence, long-term functional outcomes, quality of life (QOL), and socioeconomic consequences of severely injured patients are of increasing interest.
Long-term impairments and severe disabilities are commonly reported in patients following polytrauma [1–5, 7, 8]. Factors, such as demographics (age, gender, and BMI), severity of injury, psychological factors, social classes, and educational level have all been reported to influence the clinical and socioeconomic outcomes [1–5, 7–11].
However, most studies are retrospective in design and are conducted in highly mixed patient groups, including a large variation of different injuries. To the authors’ knowledge, the literature lack prospective studies evaluating the development of patient-reported outcomes and rate of return to work during the first year in a severely injured patient group with musculoskeletal injuries excluding patients with major thoracic, abdominal, and brain injuries. Patients with multiple and severe orthopaedic injuries are likely to present with poor outcomes [12]. Information regarding the development of QOL in patients with multiple orthopaedic injuries is important to increase the understanding of outcomes and treatment in a specialised orthopaedic setting.
The objective of the present study was to report the development of patient-reported QOL, in a patient group with musculoskeletal polytrauma, from trauma admission to 12 months after discharge from the trauma unit. Second, an explorative objective was to evaluate the rate of return to employment and the association between injury severity and patient-reported QOL at 6 and 12 months after discharge from the trauma unit.
The primary and pre-defined hypothesis was that patients would report worse patient-reported QOL compared to an age-matched reference population at 6 and 12 months after discharge from the trauma unit.
Patients and methods
Study design
The study design was a prospective cohort follow-up study including all patients admitted as trauma patients with multiple bone fractures at the Level 1 Trauma Center at Aalborg University Hospital, Denmark. Patients were included between January 2011 and December 2013.
Patients with brain injuries were excluded. Patients with a thoracic or abdominal AIS score ≥2 were excluded. Patients who were unable to fill out the questionnaires due to pre-existing mental disabilities were excluded.
Information regarding age, gender, Injury Severity Score (ISS), New Injury Severity Score (NISS), Glasgow Coma Score (GCS), mode of injury, days treated at intensive care unit, and length of hospital stay at trauma unit was obtained. Injuries following the trauma were categorised as follows: bone injuries, thorax injuries, abdominal injuries, injuries to vessels and nerves, and soft tissue injuries. Patient-reported QOL, measured by the two questionnaires, Eq5d-5L and SF-36, were obtained systematically at the time of discharge from the trauma unit and at 3-, 6-, and 12-month follow-ups at the hospital.
The primary outcome measurement was the development of patient-reported QOL (Eq5d-5L index) during the first 12 months after discharge from the trauma unit.
Explorative outcome measurements were the development of patient-reported QOL measured with the SF-36 questionnaire, employment rate 12 months after discharge from the trauma unit, and the association between injury severity (measured with ISS and NISS) and patient-reported QOL.
Following discharge, all patients received an individualised multidisciplinary rehabilitation programme. The rehabilitation programme had specifically focused on the individual patient’s specific needs to achieve the highest level of function, independence, and QOL possible. Individual planned rehabilitation was offered with additional time, during the study period. During the study period, rehabilitation was offered up to 6 months following discharge from the trauma unit.
The Danish Data Protection Agency (J. nr. 2008-58-0028) approved the study, which was performed according to the principles of the Helsinki declaration. Informed consent was obtained from all subjects. The reporting of this study complies with the Strengthening the Reporting of Observational studies in Epidemiology (STROBE) statement [13].
Patient-reported measurements
Eq5d-5L is a standardised and validated instrument to assess health outcome [14]. It consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a self-rated health scale using a 20 cm vertical, visual analogue scale with endpoints labelled ‘the best health you can imagine’ and ‘the worst health you can imagine’. An Eq5d-5L index at 1.0 indicates full health, 0 indicates death, and negative scores represent health states worse than death. Eq5d reference data from a general population-based sample in Denmark are available [15].
The Short Form 36 Health Survey (SF-36) is a 36-item, patient-reported survey of patient health [16, 17]. The SF-36 is a widely used and validated instrument developed to measure patient’s reported general health status. It comprises eight health dimensions: physical functioning, role physical, bodily pain, general health, vitality, social function, role emotional and mental health. Each of the eight dimensions is separately scored, using item weighting and additive scaling. Summed data are transformed onto a 0–100 point scale. These eight dimensions can be combined into two key health status measures: the Physical Component Summary (PCS) and Mental Component Summary (MCS). A score of zero is equivalent to maximum disability, and a score of 100 is equivalent to no disability. SF-36 reference data from a general population-based sample in Denmark are available [16].
Employment rate
Return to work was assessed with a comparison of the patient’s pre-injury employment status and employment situation 12 months after trauma discharge. The outcomes included return to employment defined as: (1) returned to pre-injury employment, (2) returned to employment with reduced time, (3) not able to return to employment following sick leave, (4) on sick leave, (5) early retirement, and (6) retired before injury. Data were collected through an interview at the time of admission to the hospital and at follow-up 12 months after discharge from the trauma unit.
Injury Severity Scores
Injury Severity Score (ISS) is an anatomical scoring system developed to provide an overall score for patients with multiple injuries [18]. Each injury is assigned an Abbreviated Injury Scale (AIS) score and is allocated to one of six body regions. Only the highest AIS score in each body region is used. The three most severely injured body regions have their scores squared and added together to produce the ISS score. The ISS score ranges from 0 to 75.
The New Injury Severity Score (NISS) is an anatomical scoring system modified from the ISS, developed to capture an overall score for patients with multiple injuries within the same body region [19, 20]. Each injury is assigned an Abbreviated Injury Scale (AIS) score. The three highest AIS scores independent of the six body regions have their scores squared and added together to produce the NISS score. The NISS score ranges from 0 to 75.
Statistics
Continuous data were expressed with means and standard deviations (SD). Skewed data were expressed with mean, median, and range. Categorical data were expressed as frequencies (%). The Eq5d was expressed with means and 95 % confidence intervals (95 % CI). The assumption of normal distribution variables was checked visually by QQ plots.
A mixed model repeated measured analysis of variance (ANOVA) and was used to analyse the development of Eq5d-5L index and SF-36 (MCS and PSC) between the time points: discharge from hospital, 3, 6, and 12 months after the trauma. If significant ANOVA factors or interactions were found, multiple pairwise analyses with post hoc test (Bonferroni) corrections were used.
At 6 and 12 months postoperatively, Pearson’s test was used for the analysis of the correlations between QOL (Eq5d-5L) and number of fractures and ISS and NISS scores.
A p value of <0.05 was considered significant. The statistical analysis was performed using the SPSS (version 22).
Results
A total of 53 patients were admitted with musculoskeletal polytrauma during the study period. The study population consisted of 18 females and 35 males. The mean age at the time of the trauma was 42.3 years, ranging from 17 to 78 years. The mean age for males and females was, respectively, 39.6 and 47.4 years. Baseline characteristics of all patients are presented in Table 1. The summary of specific injuries of all patients is presented in Fig. 1.
Throughout the study period, seven patients were lost to follow-up. One patient died during the initial treatment at the trauma unit. Prior to the 3-month follow-up, three patients refused to enter the study, including two patients who moved out of the country and one patient died. Forty-six patients completed the 12-month follow-up (87 %).
Patient-reported outcome
Twelve months after trauma unit discharge, the mean Eq5d-5L index was 0.601 (95 % CI 0.546–0.657). The mean Eq5d-5L VAS was 63.8 (95 % CI 57.7–69.9). The mean Eq5d-5L index from the time of surgery to 12 months postoperatively compared to the established Danish reference norms is presented in Fig. 2. Throughout the observational period, patients in the study population reported significantly worse QOL compared to the established Danish reference population norms as evidenced by no overlapping 95 % CI.
The mixed-model ANOVA of the Eq5d-5L indexes showed a substantial main effect for time (RM-MX_ANOVA: F 3,126 = 48.0, p < 0.001) with a significant increase in the Eq5d-5L index between the time of discharge from the trauma unit and the 12-month time point. The post hoc test showed an increase in the Eq5d-5L index, between discharge from the trauma unit and the 3-, 6-, and 12-month follow-ups (p < 0.001).
Twelve months after trauma admission, the mean SF-36 PCS and MCS scores were, respectively, 31.8 and 48.9 (95 % CI 31.8–36.3 and 45.6–52.2). The development of mean SF-36 PCS and MCS scores from discharge from the trauma unit to 12 months postoperatively compared to the age-matched established Danish reference norms is presented in Fig. 3 (PCS) and Fig. 4 (MCS). Throughout the observational period, patients in the study population reported significantly worse scores on both the PCS and the MCS scores compared to the age-matched established Danish reference population norms as evidenced by no overlapping 95 % CI.
The mixed-model ANOVA of the SF-36 PCS score showed a substantial main effect for time (RM-MX_ANOVA: F 3,126 = 29.5, p < 0.001) with a significant increase in the SF-36 PCS score between discharge from the trauma unit and the 12-month time point. The post hoc test showed an increase in the SF-36 PCS score between discharge from the trauma unit and the 3-, 6-, and 12-month follow-ups (p < 0.001) and between the 3-month and 6- and 12-month follow-ups (p < 0.035).
The mixed-model ANOVA of the SF-36 MCS score showed no main effect for time (RM-MX_ANOVA: F 3,126 = 2.2, p = 0.095) showing no significant increase in the SF-36 MCS score between discharge from the trauma unit and the 12-month time point.
Correlations between QOL and injury severity
The relationship between QOL (Eq5d-5L) at 6 and 12 months and the ISS showed no significant correlations (Pearson’s test: 6 months r = 0.13, p = 0.39; 12 months r = 0.14, p = 0.35).
The relationship between QOL (Eq5d-5L) at 6 and 12 months and the NISS showed no significant correlations (Pearson’s test: 6 months r = 0.18, p = 0.35; 12 months r = 0.20, p = 0.30).
The relationship between QOL (Eq5d-5L) at 6 and 12 months and the number of fractures showed no significant correlations (Pearson’s test: 6 months r = 0.12, p = 0.44; 12 months r = 0.02, p = 0.99).
Return to employment
Of the 46 patients who completed the 12-month follow-up, 42 patients were below the age of 65 years, which was the official retirement age in Denmark. No patients above the age of 65 years were employed before the injury.
Of the 42 patients, below the age of 65 years, 38 patients were employed before the injury (90 %). Of these 38 patients, 12 patients (32 %) returned to pre-injury work, 9 patients (24 %) were employed with reduced working hours, 7 (18 %) patients were unable to return to work, 4 (10 %) patients were on sick leave and 6 (16 %) had chosen early retirement at 12-month follow-up.
The development in QOL (Eq5d-5L) between the 12 patients who return to pre-injured work (0.640 95 % CI 0.537–0.744) and the 26 patients who did not (0.593 95 % CI 0.520–0.665) showed no significant difference between the two groups due to no overlapping 95 % CI.
Discussion
Findings of the present study evidenced the severity on patient-reported QOL and the impact on the ability to return to prior work following a high-energy trauma resulting in multiple bone fractures. The results clearly indicated that patients during the first year had significant inferior patient-reported QOL compared to an age-matched established reference population. Furthermore, only 32 % of patients had returned to earlier employment status.
Although fractures are rarely critical in the initial treatment of polytrauma patients, the impact of orthopaedic injuries on the short- and long-term outcomes is frequently reported with worse QOL and limited working capacity, which is in line with the findings of the present study [1, 4, 8, 10, 21–23]. Moreover, results from the present study are supported by studies reporting severe impairments and disabilities following major trauma at 1 year follow-up compared to established reference populations [23, 24]. Zelle et al. [4] reported decreased outcomes in patients with increasing number of factures. Moreover, it has been suggested that injuries of the lower limb are a limiting factor for successful outcomes [4, 22, 25, 26].
QOL as an important endpoint following polytrauma is generally accepted [1]. However, most studies available reported on patients with mixed injuries, including both major abdominal, thoracic, and head injuries. Moreover, little is known about the development of QOL from the time of injury and onwards and the literature lacks evidence regarding the length of follow-up needed to establish the final outcome of the patient group.
The present study showed the development of QOL from the time of injury to 12 months after the trauma. As expected, patients improved substantially during the first 6 months after injury on both Eq5d-5L and SF36 PCS scores. In contrast, it was unexpected that the development of QOL from the 6- to 12-month time points showed almost identical scores with only slight improvement on both Eq5d-5L and SF-36 PCS. These findings are supported by Holbrook et al. [23] reporting only minimal improvement in QOL between 6- and 12-month follow-ups and even less improvement between 12- and 18-month follow-ups. The same study also reported that 80 % of patients reported worse QOL compared to a reference norm at 18-month follow-up [23]. Although an individualised multidisciplinary rehabilitation programme was offered to all patients for up to 6 months following discharge from the trauma unit, findings from the present study showed that multiple orthopaedic injuries have a huge impact on patients’ QOL and that future research regarding improvement in the development of patients’ well-being is needed.
Patients’ mental outcomes following a major trauma have been the topic of several studies [7, 27, 28]. The present study used the SF-36 mental component scores (MCS) and showed that patients throughout the treatment period reported worse outcome compared to the age-matched reference population. The SF-36 mental component showed only small insignificant improvement in the 12-month observational period, which was unexpected. To the authors’ knowledge, no other studies have reported the development of SF-36 mental component in orthopaedic trauma patients. The authors suggest that during the first months following trauma, the mental disability is primarily related to an initial psychological reaction following major trauma. Furthermore, practical problems with regard to work and family, loss of self-dependency, and social isolation may have an influence on the score. Later on, the mental burden may be the result of socioeconomic impact and the experience of long-term disabilities and concerns about the future.
The ability to return to work is generally accepted as an important goal in orthopaedic trauma treatment. A number of studies conducted on different trauma populations all point to trauma as a leading contributor to work disability [1, 10, 22, 27]. Thirty-two percent of patients in the present study population resumed to prior employment status within the first year. The severe impact of orthopaedic injuries on employment is supported by MacKenzie et al. [10] reporting that one-quarter of patients with lower extremity fractures did not return to work after 1 year. Michaels et al. [27] showed that psychosocial morbidity after injury was associated with a reduced ability to return to work independent of pre-injury employment status. Moreover, MacKenzie et al. [10] suggested high positive correlations with regard to the ability to return to work and younger age, higher education level, higher income, higher social support, white-collar work, and employment that was not physically demanding. However, the present study lacks power to conduct multiple comparisons.
The Injury Severity Score (ISS) is widely used in assessing severity of injury following polytrauma [2, 3, 20]. It has been recognised that, by only allowing the score to consider the worst injury for each body system, ISS may underestimate the problems of multiple musculoskeletal injuries [20]. To improve the evaluation of injury severity in polytrauma patients, especially with multiple orthopaedic injuries, the New Injury Severity score (NISS) has been introduced [19]. Sutherland et al. [20] reported that NISS better predicts functional outcomes in survivors of musculoskeletal trauma. However, these findings are not supported by results of the present study reporting no significant correlations between QOL (Eq5d-5L) and ISS or NISS.
Overall, patients’ development of QOL and the ability to return to work following an orthopaedic polytrauma may depend on a number of different aspects. The literature suggested factors included: objectively measurable impairments, mental disability, subjective reactions, personal expectations, education, cultural background, social factors, and economy [1, 27]. Furthermore, a large-scale retrospective study by O’Toole et al. [29] reported that the most important drivers in patient’s satisfaction following major lower limb trauma seem to be physical function, less pain, the absence of depression, and the ability to return to work. Moreover, O’Toole et al. [29] reported that patient’s satisfaction was not related to details of the injury, patient demographics, or psychological profile of the patient. As a consequence, the factors determining the outcomes following orthopaedic polytrauma are most likely complex and multifactorial. Results of the present study showed that recovery following orthopaedic polytrauma appears to be prolonged, and some residual disability may be expected. To the authors’ knowledge, the present study is the first to prospectively report the development of QOL in a heterogenic group of polytrauma patients with multiple bone fractures with a 12-month follow-up period. The authors suggest that studies on heterogeneous groups of polytrauma patients are important to improve current treatment and to better advise patients during recovery and to understand the development of QOL.
The main limitation of this study was the observational design, implying that no conclusions regarding causality can be drawn. The number of analysis conducted may increase the risk of type 1 errors. However, this study provided novel findings and useful clinically information, relevant for future clinical trials. Moreover, findings provide importance information to trauma surgeons increasing their ability to advise patients regarding QOL, rehabilitation, and their ability to return to work following an orthopaedic polytrauma. Due to the limited sample size, the evaluation of the impact of specific injuries on QOL is not possible. The strength of this study was the prospective design and the Eq5d-5L and SF-36 reference populations. Reference populations offer a unique opportunity to evaluate the outcome of patients compared to the general population.
Conclusion
Throughout the 12-month observational period, patients reported worse QOL compared to the age-matched reference population. The development of QOL from 6- to 12-month time points almost showed identically scores with only little improvement. At the end of 1-year follow-up, 32 % of patients had resumed prior employment.
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Larsen, P., Goethgen, C.B., Rasmussen, S. et al. One-year development of QOL following orthopaedic polytrauma: a prospective observational cohort study of 53 patients. Arch Orthop Trauma Surg 136, 1539–1546 (2016). https://doi.org/10.1007/s00402-016-2550-5
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DOI: https://doi.org/10.1007/s00402-016-2550-5