Outcome measurement in orthopaedics has evolved rapidly over the past 20 years, and there are many patient-reported or clinician-based outcome measures.1,2 The popularity of patient-reported outcome (PRO) measurement, in particular, has grown in response to the perception that clinicians have an incomplete understanding of the true impact of disease on a patient's life and the complexity of the human illness experience.2,3 PRO measures, by definition, focus on quantifying the subjective impact of health from the patient's perspective, commonly referred to as “disability” in contrast to “impairment” (objective pathophysiology). Common orthopaedic outcomes such as range of motion and fracture union represent the biomedical paradigm. PRO measures represent the biopsychosocial paradigm (including the influence of thoughts, emotions, behaviors, and circumstances) on symptoms and limitation.
The International Classification of Functioning, Disability and Health defines disability as a multidimensional concept related to the dynamic interaction between body functions and structures, activity limitations, and participation restrictions alongside environmental and personal factors.3 These components are influenced by impairment (ie, problems with structure and function of the body leading to significant deviation and loss), psychosocial factors, and symptom experience.3 The alleviation of disability, in this wider context, is the primary aim of most orthopaedic interventions.
Orthopaedic trauma is often associated with a significant impact on the magnitude of disability and the factors influencing it, which can affect an individual's quality of life in several health domains.4,5 There is increasing evidence that disability is less associated with measures of impairment and objective pathophysiology than the subjective psychosocial aspects of illness.6,7 Factors likely to mediate these interactions include anxiety, depression, ineffective coping, pain catastrophizing, and kinesiophobia, as well as social status, support, financial loss, and secondary gain.4–8 This has an influence on recovery following musculoskeletal trauma, which is shown to have a stronger association with pain intensity and disability than biomedical factors, such as fracture type.8–10 Furthermore, studies such as those conducted by Bhandari et al4 reported on a significant number of patients experiencing orthopaedic trauma breach thresholds for psychological distress.
Upper limb injuries demonstrate reduced health-related quality of life indices compared with trauma involving other regions.11 The inability to feed, clothe, and care for oneself following injury, particularly involving a dominant arm, can be extremely debilitating.11 A study involving proximal humerus fractures demonstrated that measures of impairment, such as range of motion and arm strength, did not correlate with PRO measures of disability.12 Factors such as social independence appeared to more accurately predict PROs than physician based assessments and even mortality in these patients.12,13 Similarly, studies involving distal radius fractures demonstrate depression, anxiety, kinesiophobia, and catastrophic thinking as the most important factors influencing disability and rate of recovery.9,14,15 Despite this growing evidence and the rising demand for robust PRO measurement, there remains a lack of clarity regarding the original development, testing, and quality of PRO measures in the context of upper extremity trauma and disability in this region.
The primary objective was to identify outcome measures developed for upper extremity conditions, focusing on traumatic injuries, and to classify them by anatomic region, condition type, instrument type, and the psychometric evaluation used in their original development. Secondarily, we aimed to assess the methodological quality of original studies, introducing a PRO measure that incorporated trauma patients in their development. We conclude by highlighting the challenges and solutions encountered in measuring outcomes and disability in this population.
A broad search strategy was applied to PubMED (MEDLINE from 1946 to 2016), OVIDSP (EMBASE from 1974 to 2016), CINAHL (from 2006 to 2016), and PsycINFO (from 1806 to 2016) electronic databases on July 1, 2016. Search terms related to “upper limb anatomy,” “outcome measurement,” and demographic parameters were combined with the operator AND (Supplemental Digital Content 1, http://links.lww.com/JG9/A2). No restrictions were set in the search fields, and terms were identified in the title and/or abstract without any limits. Further identification was conducted through an internet search engine (Google) and a contemporary atlas of outcome measures.3 The review is reported according to the PRISMA statement and registered on the PROSPERO system (No. CRD42016046243) (Appendix 1).
Studies involving adult patients experiencing any orthopaedic upper extremity condition involving outcome measurement systems were identified. Abstracts were screened by the lead investigator (P.J.) to (1) generate a comprehensive set of outcome measures and (2) track down the original article introducing the measure plus or minus any development and psychometric evaluation studies, if available. Psychometric evaluations of PRO measures were taken to include assessments of validity, reliability, responsiveness, interpretability, and acceptability.16 Eligibility assessment selected only the original publications of PRO measures for qualitative and quantitative synthesis. Measures not recognized as multidomain outcome measurement systems, such as those focusing on clinimetric features alone (eg, range of motion, pathoanatomic or radiological grading and classification, and clinical examination tests), single health components (eg, pain, depression, and return to activity), broad diagnostic groups (eg, osteoarthritis and tumor classifications), and health behavior scales, were excluded along with articles not published in English.
Data Extraction and Data Synthesis
Data were extracted, synthesized, and recorded using an electronic database (Microsoft Excel, v15.33). Outcome measures were classified by anatomic region, conditions assessed (ie, broad etiology and specific diagnoses), instrument characteristics (ie, coverage and type), and initial level of psychometric evaluation. Measures combining patient-reported and clinician-based components were classified as the latter by default, unless one or the other was more popularly used in the literature. Initial characterization of psychometric evaluation was based on details of validation (construct validity). If none existed, measures were classified with “no initial empirical psychometric evaluation” or “no initial empirical psychometric evaluation and no validation studies identifiable.”
Quality assessment was conducted using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria and 4-point checklist.17 This is a well-established standard for evaluating methodological quality, design requirements, and preferred statistical analysis of measurement properties of health-related PRO measures. Only original studies involving patients with trauma conditions in the development and psychometric evaluation of instruments were assessed. Contact with authors was made for clarification of conditions when these were nonspecific. Properties were assessed with the lowest rating within a category taken as the score for the section. In addition, data were extracted for generalizability (ie, population characteristics and sampling procedure) and interpretability but were not rated. The items within PRO measures were also categorized as “best fit” into one of the five health domains by three investigators (P.J., D.R., and S.G.) to calculate the proportion (percentage) of each domain as part of the full score, including any instrument weightings. Discordant judgments were resolved through discussions coordinated by the lead author (P.J.) to reach a consensus between the three investigators. Synthesized data were reported using descriptive statistics and discordant judgments resolved by a discussion among all the authors.
A total of 144 outcome measures targeting the upper extremity were identified (Figure 1 and Table 1). The majority focused on the shoulder, wrist, and hand (Figure 2). Fifty-eight percent (n = 83/144) included patients with trauma problems either in combination with other conditions or alone (Figure 3). Seven percent (n = 10/144) required corresponding authors to be contacted to determine conditions investigated because these could not be otherwise identified. Conditions included fractures, dislocations, and soft-tissue injuries (Table 1). Instrument classification revealed the majority as completely or partially clinician based (53%; n = 76/144) (Figure 4) and predominantly condition specific (56%; n = 80/144) (Figure 5), with trends in instrument type and coverage mapped over time (Figures 6 and 7).
Quality assessment was conducted on 29 original studies (20%; n = 29/144) that included some form of psychometric evaluation of PRO measures when they were first published and involved upper limb trauma patients in their study cohort (Table 2). The majority of studies included in quality assessment were prospective cohort studies. “Test-retest” reliability was assessed more frequently than internal consistency and measurement error, and rating was “poor” to “good” when assessed. Content (face) validity ratings were “good” to “excellent” for almost all measures. Construct validity assessed through testing of hypotheses rated “good to excellent” in two thirds of studies and “poor to fair” in the rest, while structural validity was “poor” in 71% of studies (n = 17/24) when it was assessed. This was primarily due to few studies undertaking factor analysis or item response theory (IRT) analysis, a requisite for higher ratings. The lack of gold-standard measures in this field meant that criterion validity was rarely assessed. Responsiveness was highly variable; although most studies allowed some interpretability through score distribution and change, few conducted analysis of floor-ceiling effects, minimal clinical important difference, or minimal detectable change. Characterization of health domains revealed that the majority of items were related to physical function and symptoms, whereas the relative proportion represented by social (median 14%; range 3%–35%) and psychological aspects (median 14%; range 3%–16.5%) was low. Generalizability assessment revealed low levels of reporting patient consent, percentage of missing items, and study limitations.
The selection of outcome measures is of paramount importance in conducting high-quality orthopaedic research.48 Arriving at this choice, particularly among the current assortment of PRO measures, may benefit from an understanding of the methodological quality of their development and relevance to study populations.49 Over 140 different outcome measures targeted at upper extremity problems were identified, with a substantial number involving trauma conditions in their original cohorts, many of which included distal radius fractures, rotator cuff tears, and shoulder instability. The majority were clinician-based, injury-specific, or procedure-specific instruments and lacked empirical psychometric evaluation in initial development or any identifiable validation studies since introduction. One in five was a PRO measure, involving trauma patients who had undergone initial psychometric evaluation. Methodological quality was deemed acceptable in terms of test-retest reliability, content, and construct validity through hypothesis testing, but was of variable quality and/or lacking in others such as internal consistency, measurement error, responsiveness, and interpretability. This work also demonstrated a transition from pure clinician-based measures to nonvalidated PRO measures to those with some form of validation before introduction (Figure 6). A further trend toward an increase in the development of region-specific instruments over condition-specific measures is observed (Figure 7). This may reflect the importance placed on PRO measurement in modern orthopaedic practice as well as a possible trend toward more general outcome measurements of disability impact at the regional level. Despite these findings, relatively low rates of patient-reported assessment have been observed in the orthopaedic trauma literature, and the drive to develop these instruments does not appear to correlate with their level of utilization in clinical practice.50
There are some limitations to this work. First, only the original index articles relevant to each outcome measure were within scope. We were interested in understanding the nature of the original developmental work by the investigators and the methodological quality of these measures. Although we located the studies for each instrument, it is recognized that more than one early investigation could lay claim to being part of the initial psychometric evaluation. Furthermore, subsequent studies may have superseded these index evaluations, performing further assessments, including specific trauma populations. Second, although the proportion of psychosocial components within our selection of PRO measurements was judged to be low, it is appreciated that investigators may incorporate other measures to account for psychological and social well being. Third, the identified outcome measurement set is unlikely to be exhaustive, but intuitively any instruments “missed” are more likely clinician-based than patient-reported. In this regard, there is an issue of publication bias and its impact on the internal validity of this work.51 Unpublished studies reporting negative, unfavorable outcomes following instrument testing may exist. The lack of reporting limitations in many of the studies may also reflect a level of reporting bias where there has been a vested interest in instrument promotion. Fourth, we recognize that “all upper extremity trauma conditions” were included as the target category, and findings around methodological quality of measures may vary if the evaluations were performed around specific injuries. Finally, in 7% of authors contacted, inquiries were limited to diagnostic clarification, and no further information was gathered around methodological quality. Thus, it was unclear whether low ratings were down to lack of reporting or actual lack of quality according to COSMIN. The findings of this review can be considered in light of some of the challenges and solutions in this field.
Timing and recruitment of orthopaedic trauma patients for instrument development, testing, and outcome assessment may be logistically difficult because of a variety of clinical and environmental stressors. Measurement should occur at a time when patients are “stable” enough to perform evaluations while being close enough to the date of injury to fully capture the health-related impact. This can be challenging when considering the effects of symptoms (eg, fracture-related pain) and clinical circumstances (eg, fracture immobilization). These issues may be unavoidable but managed best by improved patient and staff education as outcome measurement becomes part of everyday orthopaedic practice.
Responder burden plus inefficient and irrelevant testing are further issues, especially when full and lengthy fixed-length outcome measures are administered in these populations. The risks of incomplete scoring, poor patient experience, “gaming” of the assessment for perceived reward, and difficulties in estimating performance while being “out of action,” alongside the tendency to overestimate one's level of ability in these situations, are apparent.52
Functionality and psychometric properties of instruments primarily developed in chronic conditions may lack adequate coverage and incorporate a set of items too narrow and limited in assessing health impact outside this context.53 This tendency may be reflected by high floor-ceiling effects during applications in trauma.3,53 Furthermore, instruments or groups of instruments should adequately cover all relevant health-related domains, including psychosocial factors which are shown to have a dominant influence on disability.
Tailored assessment of patients is an ongoing challenge within outcome measurement in general. It is particularly relevant in orthopaedic trauma where population characteristics are wide ranging. One component involves the assessment of a patient's baseline status, a particular challenge in trauma situations. Other aspects include the capture of patient experience and emerging concept of patient activation, an individual's level of involvement in his or her care and the propensity to engage in adaptive health behaviors.28,29,54
One or more of these challenges can be met by the introduction and/or mode of application of established and contemporary outcome measurement systems. First, combinations of region-specific and generic measures with instruments measuring specific factors of relevance, such as depression and pain interference, could be applied to more comprehensively assess patient-focused, health-related outcomes. Instrument choice should depend on the psychometric attributes of the measure, methodological quality in development, and evidence of validation in the target population.49 Generic PRO measures have gained popularity in trauma as they provide a more holistic measurement of health-related outcomes in the multiply injured and medically complex patient, while allowing comparisons between interventions.3 Collaborative efforts are underway to develop standardized outcome sets through a consensus-based selection of generic and specific outcome measures.55
Second, abbreviated versions of well-established scales (eg, QuickDASH) have been developed to improve efficiency and performance while maintaining validity against their full-version counterparts.19 Another contemporary solution involves computerized adaptive tests (CATs). CATs are dynamic tests using computers to administer test items based on the IRT mathematical model.56–58 An IRT-based algorithm allows adaptation to the patient's last response and administration of relevant subsequent items from a large question bank.58 The Patient-Reported Outcome Measurement Information System (PROMIS) developed by the US National Institute of Health is one of the most commonly used CAT systems.56–58 PROMIS CAT scores range from 0 to 100, with 50 points as US general population mean. They enable capture of physical (eg, physical function and pain interference), mental (eg, anxiety, and depression), and social (eg, social isolation) health domains through modules that can be tailored to the study and population being assessed.56 Customization, avoiding redundancy, minimizing floor-ceiling effects, and maximizing scoring efficiency and measurement precision are clearly advantageous in the trauma setting.56–58 Studies have demonstrated the correlation of CATs with popular fixed-length scales.59
In general, computer-based outcome assessment represents a positive paradigm shift, with instruments such as PROMIS CATs being incorporated in outcome measurement software by well-established organizations such as the AO Foundation.60 It is important to note that PROMIS CATs were originally developed for chronic conditions, and their development as regional measures (eg, PROMIS Upper Extremity Physical Function CAT) and evaluation in traumatic conditions is ongoing.56,61 Other outcome measures with adaptive capabilities, but delivered through a paper-based format, include the FLEX-SF shoulder instrument and short-form PROMIS measures.56,62
Some fixed-length scales have also been designed to provide a more relevant, patient-specific assessment by factoring in patient-reported “levels of ability” and “levels of necessity” in relation to various activities.42 Other instruments have focused on accurate measurement of functional progress and minimizing the discrepancy between what patients report and what they actually do, by clinician-observed grading of enacted activities of daily life in real time.63 PRO measures such as the PFWO and ULFI are designed to capture recall of preinjury performance and baseline function.21,44,45 The former includes a component that accounts for compensatory mechanisms in performing daily activities.44,45 Another strategy in establishing a baseline involves the use of patient proxies, such as family and friends, to aid in recall of preinjury function during the early postinjury phase.64 In terms of patient satisfaction with various health domains, the MHQ includes a component measuring satisfaction with appearance, physical function, and symptoms.41 Patient experience, including satisfaction with care, is often assessed through separate scales, although instruments such as the SRI and MWQ evaluate this aspect in musculoskeletal trauma and wrist/hand injuries, respectively.43,65 Early work on patient activation measures has demonstrated a direct correlation with satisfaction among upper extremity conditions and musculoskeletal trauma patients, as well as improved pain relief, mental health, and reduced disability.66,67 Further research is necessary to assess correlation with PROs.
This work has systematically reviewed the methodological quality of studies involving PRO measurements in upper extremity trauma on a broad scale. Focused evaluations, using the COSMIN checklist, have been conducted in distal radius fractures; however, the literature in this area is lacking overall.49 Instrument properties should be defined for the population being tested and not for the PRO instrument itself.3,13 In reality, PRO measures have been used throughout orthopaedics in patient groups for which the instrument was not initially developed or psychometrically evaluated.3,13 It is unclear whether commonly used instruments can measure all the health-related aspects surrounding upper limb trauma important to the individual. These measures are commonly selected by intuition, clinical culture, and familiarity, with the belief that they are “fit for purpose” and capable of capturing the substantive components of disability experienced by these patients. Ultimately, PRO measurement selection requires careful consideration of the methodological quality, and further research is required to evaluate their psychometric properties in these populations. Reaching a consensus on outcome measurement sets in trauma that are delivered in a standardized fashion will form a more complete, comparable, and interpretable assessment of disability in these populations.68
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Appendix 1 PRISMA 2009 Checklist