- Open Access
There are more things in physical function and pain: a systematic review on physical, mental and social health within the orthopedic fracture population using PROMIS
Journal of Patient-Reported Outcomes volume 6, Article number: 34 (2022)
The Patient-Reported Outcomes Information System (PROMIS®) is more and more extensively being used in medical literature in patients with an orthopedic fracture. Yet, many articles studied heterogeneous groups with chronic orthopedic disorders in which fracture patients were included as well. At this moment, there is no systematic overview of the exact use of PROMIS measures in the orthopedic fracture population. Therefore this review aimed to provide an overview of the PROMIS health domains physical health, mental health and social health in patients suffering an orthopedic fracture.
This systematic review was documented according to the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines. We searched Embase, Medline, Web of Science Core Collection, and Cochrane Central Register of controlled Trials, CINAHL and Google Scholar in December 2020 using a combination of MeSH terms and specific index terms related to orthopedic fractures and PROMIS questionnaires. Inclusion criteria were available full text articles that were describing the use of any PROMIS questionnaires in both the adult and pediatric extremity fracture population.
We included 51 relevant articles of which most were observational studies (n = 47, 92.2%). A single fracture population was included in 47 studies of which 9 involved ankle fractures (9/51; 17.6%), followed by humeral fractures (8/51; 15.7%), tibia fractures (6/51; 11.8%) and radial -or ulnar fractures (5/51; 9.8%). PROMIS Physical Function (n = 32, 32/51 = 62.7%) and PROMIS Pain Interference (n = 21, 21/51 = 41.2%) were most frequently used questionnaires. PROMIS measures concerning social (n = 5/51 = 9.8%) and mental health (10/51 = 19.6%) were much less often used as outcome measures in the fracture population. A gradually increasing use of PROMIS questionnaires in the orthopedic fracture population was seen since 2017.
Many different PROMIS measures on multiple domains are available and used in previous articles with orthopedic fracture patients. With physical function and pain interference as most popular PROMIS measures, it is important to emphasize that other health-domains such as mental and social health can also be essential to fracture patients.
The number of orthopedic fractures are globally increasing and present a sincere burden on both health related and socioeconomic status of individual patients and communities . Orthopedic fractures are known for negative interference in work status, health related quality of life, impairments and health care costs [1,2,3]. An orthopedic trauma is defined as any injury to the bones, joints and/or soft tissue caused by an external force and bone fractures are all disruptions in bone continuity. In order to measure patient outcomes, patient-reported outcomes measures (PROMs) have been evolving rapidly . In clinical practice, PROMs are used to obtain patient reported information on diverse and essential health aspects like physical function, pain, and mental and social health. More specifically, the impact of treatment and health condition can be assessed by using PROMs [5, 6]. Many available PROMs for the orthopedic trauma populations are anatomical region specific fixed scales (e.g. FAAM, FADI, DASH, ASES or KOOS), rather than more generic questionnaires and a full survey must be completed by the patient [7, 8]. This can be time-consuming for the patient and healthcare provider, but is required to gain a valid score . Short form fixed scales are also available, but might be limited in precision if the number of questions is not reduced properly . On top of this, fixed scales are prone to floor and ceiling effects, since fixed scale questions are often limited of scope with regards to important health domains .
Given these limitations, the Patient Reported Outcomes Information System (PROMIS®) was established. PROMIS was developed to gain generic outcome measures into a more valid, generalizable and reliable method . The great advantage and characteristic entity of PROMIS is the possibility of applying Computerized Adaptive Testing (CAT), which is based on the Item Response Theory (IRT). In IRT, a computerized algorithm uses the previous answer to provide the next question. Additional questions follow until a valid and precise score has been reached with a standard error less than 3.0 on the common metric of a T-score. This normally results in a compact questionnaire with less time effort for the patient and a lower administrative burden . PROMIS measures are demonstrated in T-scores that are standardized to the (U.S.) general population. These PROMIS T-scores range from 0 to 100 with a mean of 50 and a standard deviation of 10 points on the T-score metric. Greater T-scores represent more of the outcome being quantified, thus in a positive context, a higher T-score means a better outcome and in a negative context, a higher T-score means a worse outcome.
PROMIS captures three essential health domains for a generic population, namely the physical health domain, the social health domain and the mental health domain. These three health domains are also important to orthopedic fracture patients and might, because of the acute health shift differ from general orthopedic populations [14, 15]. For example, depression or anxiety (mental health domain) after a traumatic fracture decrease quality of life, but also tend to limit physical progression and extend the usage of pain medication [16, 17]. On top of this, the measurement of physical function (physical health domain) shows the functional status of patients and could be used to interfere early into the recovery process when physical function is regressing. Lastly, fractures have been associated with a limitation in social interaction [18, 19]. Due to the advantages of PROMIS measures and due to the importance of monitoring the different health domains in orthopedic fracture patients, there is an increasing number of publications in recent medical literature, including some systematic reviews, using the PROMIS questionnaires in this subgroup [4, 20,21,22,23,24]. Multiple papers have been published in which PROMIS tools were seen in the view of outcome measures or in which PROMIS tools were validated, but many articles studied heterogeneous groups with chronic disorders including orthopedic patients in general [4, 8, 25,26,27,28].
Previous systematic reviews on PROMIS in orthopedic patients primarily focused on physical function in general orthopedic populations, with the argument that PROMIS physical function has been most thoroughly studied in musculoskeletal disorders . On top of this, some systematic reviews showed an underrepresentation of orthopedic trauma patients in general or orthopedic fracture patients or could only include a limited amount of studies on health domains different from physical function [4, 24]. Furthermore, one systematic review only assessed trauma patients with upper limb trauma .
Although the importance of health domains physical function, mental health and social health are evident, there is no recent systematic overview that provides a thoroughly outline of all PROMIS health domains in the orthopedic fracture population specified into subgroups with different upper and lower extremity fractures. Therefore, the primary goal of this review was to provide an overview of studied PROMIS health domains in patients suffering an orthopedic fracture. We aimed to determine the frequency and extensiveness of usage of available PROMIS measures. Secondly, the use of PROMIS differentiated by type of fracture was assessed to evaluate if PROMIS is more often used in specific fracture types.
This systematic review was documented according to the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines .
The literature search was performed in December 2020 with the assistance of a professional biomedical information specialist at the Erasmus Medical center Rotterdam. Literature was extracted from the medical databases Embase, Medline, Web of Science Core Collection, Cochrane Central Register of controlled Trials, CINAHL and Google Scholar. A combination of MeSH terms and specific index terms related to orthopedic fractures and PROMIS questionnaires were used. See Additional file 1: Appendix 1 for the full search strategy.
Articles were eligible for inclusion when (1) any PROMIS questionnaires in both the adult and pediatric extremity fracture population were described, (2) the study was published in English or Dutch and (3) full text of the article was available. Since our goal was to provide an overview of the different PROMIS health domains in patients suffering an orthopedic fracture, and PROMIS offers the opportunity to explore health domains in adults and children, both groups were included. Lower extremity fractures were defined in our study as fractures reaching from pelvis to toes, and upper extremity fractures reached from scapula to fingers. Articles in which fracture patients were part of a large heterogeneous population and where results were not specified for fracture patients were excluded. Conference papers, abstracts, editorials, study protocols, systematic reviews, and meta-analysis were also excluded. Two reviewers (T.H. and L.M.) screened all papers based on title and abstract. Disagreement between the reviewers was resolved by discussion with a third member of the research team (M.J). Next, one reviewer (T.H) collected full texts of papers. The medical library was consulted if full texts of papers could not be extracted from the internet. These full-text papers were screened for eligibility by T.H. and L.M. Reference lists from selected papers were manually screened by two reviewers (T.H. and L.M.) to identify additional eligible papers.
Figure 1 shows the PRISMA flow diagram illustrating the process of screening and identification of eligible articles.
Both reviewers (T.H. and L.M) assessed the quality of included observational papers by using the Strengthening. The Reporting of Observational Studies in Epidemiology (STROBE) checklist . Disagreement in quality assessment was resolved by discussion with a third reviewer (M.J). The STROBE checklist provides recommendations on items that should be addressed in observational studies. Items on the STROBE checklist were reported in a binary way (1 = the item was sufficiently reported, 0 = the item was insufficiently or not reported). In total, 34 items can be scored by using the STROBE-checklist. Since the STROBE-checklist is not suitable for the assessment of case series, the CARE guidelines were used as a framework to assess content of included case series . Methodological quality of randomized controlled trials was assessed by using the Downs and Black Checklist .
The first reviewer (T.H.) extracted data from included papers onto a shared excel file, which was reviewed and if needed supplemented by the second reviewer (L.M.). Extracted information included: (1) basic study -and publication characteristics (first author, country in which the study was performed, level of evidence according Evidence-based nursing care guidelines, study design, primary aim, and inclusion and exclusion criteria); (2) study population characteristics (population type, injury type, number of patients, sex distribution, mean age, follow up time and level of trauma center); (3) PROMIS features (number of PROMIS forms, type of PROMIS forms, context and PROMIS scores).
The initial search resulted in the selection of 3888 papers. Duplicates were removed and 1751 articles remained eligible for screening. In total, 1305 articles were excluded following screening by title and abstract. The medical library was requested for assistance in the search for full-text papers of which 6 articles were not available, leaving 440 articles to be assessed for full text. Finally, 51 papers were included for this review.
Overall study quality
Most articles were based on a retrospective -or prospective observational design with a cross-sectional or case–control setting (n = 47, 92.2%). Additionally, 2 (3.9%) randomized controlled trials and 2 (3.9%) case series were included.
An overview of study quality assessment can be found in Additional file 2: Appendix 2, Additional file 3: Appendix 3 and Additional file 4: Appendix 4. The mean quality score of the 47 observational articles according to the STROBE checklist was 26.5 out of 34 (SD = 3.2). More than half of the papers did describe how missing data were addressed (item 12c, n = 26 studies, 55.3%), lacked the description of any sensitivity analysis (item 12e, n = 32 studies, 68.1%) or did not use a flow diagram (item 13c, n = 39 studies, 83.0%). Papers adequately described balanced information on the scientific paper (item 1b, n = 47 studies, 100%), scientific background and rationale for the investigation (item 2, n = 47 studies, 100%), eligibility criteria (item 6a, n = 46 studies, 97.9%), key results with reference to the study objects (item 18, n = 47 studies, 100%) and limitations of the study (item 19, n = 46 studies, 97.9%). The article which was ranked as the lowest by using the STROBE checklist scored 18 points  versus 32 points for the article which scored the highest . Two studies were assessed by using care guidelines for case series with a mean score of 22.5 out of 30 (respectively 21 and 24 points) and two studies were assessed by the Downs and Back checklist with a mean score of 20 out of 27 (respectively 18 and 22 points).
Table 1 presents the basic characteristics of the included studies.
A single fracture population was included in 47 studies of which 9 involved ankle fractures (9/51; 17.6%), followed by humeral fractures (8/51; 15.7%), tibia fractures (6/51; 11.8%) and radial or ulnar fractures (5/51; 9.8%). Less than a third of all papers involved more than 2 fracture subgroups (16/51; 31.4%) and 3 papers (3/51; 5.9%) did not specify their subgroup (Fig. 2). Sample sizes ranged from 7 to 975 and most studies only included patients ≥ 18 years old in their papers (39/51; 76.5%). The patients’ age ranged from 1  to 99  years.
Included articles in this review showed a gradually increasing frequency of PROMIS questionnaires in the orthopedic fracture population since 2017, with already 2 published papers in January 2021. All studies were conducted in the USA (46/51; 88.2%) or UK (6/51; 11.8%) (Fig. 3). Most studies were performed in a level 1 -or tertiary care trauma center (37/51; 72.5%) (Table 1).
Figure 4 shows all used PROMIS measures divided by subgroups for the adult PROMIS measures, PROMIS parent proxy measures and pediatric PROMIS measures. For both the upper and lower extremity fractures, the PROMIS Physical Function (n = 32, 32/51 = 62.7%) and PROMIS Pain Interference (n = 21, 21/51 = 41.2%) were most frequently used questionnaires in the physical health domain. PROMIS Physical Function Upper Extremity (n = 16, 16/51 = 31.4%) was most frequently used in the upper extremity group. PROMIS measures concerning social and mental health were much less often used as outcome measures in the fracture population. In the mental health domain, one research group accounted for more than one third (n = 4, 4/10 = 40%) of all mental health questionnaires in multiple papers [36,37,38,39], i.e. PROMIS depression, PROMIS emotional distress- anxiety and PROMIS psychosocial impact-positive. The upper extremity population was most frequently asked about mental health. The social health domain was studied in 5 different papers and again, 4 papers were published by the same research group [36,37,38,39]. The studied social health domain included: emotional support, instrumental support and satisfaction with social roles and activities. As an overall evaluation of a patients’ physical and mental health, the PROMIS global health questionnaire was studied in 4 articles [20, 40,41,42].
Additional papers concerning the pediatric population and pediatric measures, primarily focused on PROMIS® pain interference, PROMIS physical function upper extremity and PROMIS peer relationships. On top of this PROMIS physical function and PROMIS physical function mobility were used as outcome measures.
The primary goal of this systematic literature review was to provide an overview of PROMIS measures in the orthopedic fracture population. The aim was to determine the frequency and extensiveness of usage of available PROMIS measures (physical health, mental health and social health). Secondly, we assessed the use of PROMIS differentiated by type of fracture to evaluate if PROMIS is more often used in specific fracture types.
The systematic review shows that some fracture populations were in particular subject of research in the use of PROMIS measures. Fractures of the ankle, humerus, tibia and radius/ulna and elbow account for more than 50% of all included papers. The popularity of these fracture populations could possibly be found in the high incidence of specific fractures and the previous use of legacy measures/fixed scales other than PROMIS measures for these populations [7, 81] in combination with the validation of PROMIS measures for these certain groups .
Sex differentiation in this review showed a female proportion of 0–78% in included studies. Twenty included studies showed a female proportion of ≥ 50% and ten studies showed a female proportion of ≥ 45%. As fractures show a gender -and age specific pattern in which males are more often exposed to fractures in the age from 12 to 50 and females exceed the males from 50 years of age, it could generally be noticed that females were adequately represented . Spread in follow up time was large and documentation of PROMIS measures diverse. Ideally, the use of PROMIS measures or PROMs in general could generate data on regular dates to enlarge generalizability and comparison between data. Only research performed in level I trauma centers or academic/tertiary centers were seen in this systematic review. For generalizability of the fracture population, it would be better to also include patients from non-trauma or non-academic centers.
The results also show that the physical health domain was most often used in the assessment of orthopedic fracture patients. Especially physical function and pain interference were highlighted in the included papers. A recent systematic review showed that PROMIS physical function strongly correlated with other frequently used orthopedic PROMs in upper -and lower extremity patients . Orthopedic fracture patients are in the current healthcare system being assessed in the emergency department in the acute setting, in (virtual) fracture clinics for follow up after the emergency department and in consultant specialty fracture clinics in the case of more complex fractures for follow-up or additional (surgical) treatment . Since physical function and pain is the main measure of progress for orthopedic conditions, it is comprehensible to firstly evaluate this domain. Patients seen in the acute phase could primarily be provided with PROMIS questionnaires physical function and pain, but for follow up in fracture clinic or specialty consultant fracture clinic, additional questionnaires regarding social and mental aspects could be of value to patient centered care.
As seen in the results of our study, social health and mental health were assessed in the minority of included articles. Traditionally, outcomes in trauma patients focused on in-hospital parameters and survival . As survival to discharge improved, post discharge and long term quality of life outcomes became more important to injured patients [14, 15]. Yet, as this systematic review shows, papers merely focus on the physical health domains. Increasing evidence is found that health aspects other than physical functioning are important for recovery to patients with one or more bone fractures . Firstly, mental health could be limited by depressive or anxious symptoms after trauma, which are noted for reducing the overall quality of life, but mental health also tends to limit physical progression and extend the usage of pain medication [16, 17]. Secondly, patients with bone fractures have to deal with social insecurities. Patients could be uncertain about the future, the ability to work, the need for social support and their own view on their body image [87, 88]. Early intervention into social and mental health problems is known for reducing the number of hospital readmissions , improving reintegration into the community  and improving overall health related quality of life after a trauma . So, patients seen in specialty fracture clinics with more complex fractures, slow progress in physical recovery or complications are prone to have additional health problems and needs and could therefore be supported with additional PROMIS measures exploring social and mental health.
PROMIS measures, including social and mental health, can easily be explored by short forms and CAT-versions in which the response burden for participants and clinicians is limited and estimates be more precise . Clinicians are able to be informed in advance of outpatient clinic visits on a patients’ health status and can anticipate on possible problems. Simultaneously, implementation of PROMIS measures as part of the electronic medical report (EMR) to summarize health status of the patient is possible. This potentially limits administrative tasks for physicians. On top of this, progression on different health domains can be visualized by implementation into the EMR which improves understanding and discussion with the patient . By showing results to patients, the threshold to discuss difficulties in physical, mental and social health could be lowered and patients could feel supported as already seen in studies with multi-morbidity patients . The orthopedic trauma surgeon could also use health information to refer patients to supporting departments, such as the pain management specialist, the psychology department or social work, and in return, these departments can read and interpret the outcomes of PROMIS measures too. Simultaneously, comparison between PROMIS measures in fracture subgroups is easier, since PROMIS scores are generalizable, efficient and highly reliable. Lastly, the disadvantage of low generalizability in several different legacy PROMs to assess injuries in similar anatomical locations can be tackled by the use of PROMIS [4, 7, 23].
Results of our study showed a preference for research of mental health constructs in patients with upper extremity fractures. No conclusive explanation could be found to this observation, since both upper extremity injuries as lower extremity injuries are associated with limitations in mental health (and social health and physical health) [95,96,97,98]. Future research could therefore focus on differences between mental health outcomes in upper extremity fracture patients and lower extremity fracture patients by use of PROMIS measures. Furthermore, future research could also focus on the impact of trauma on social aspects of life (e.g. work, ability to participate in the community, support preferences, social interaction after trauma and reaching the preliminary social status). On top of this, the effect of the use of PROMIS in outpatient fracture clinics on the felling of support and health related quality of life could be expanded.
Included articles were conducted in the United States and the United Kingdom. Papers from other countries were available in the primary/initial search, but did not meet our inclusion criteria. For example because of inclusion of heterogeneous populations not specified to fracture patients. Nevertheless, articles from English speaking countries with PROMIS-networks like Canada and Australia were lacking. In Canada, PROMIS measures are translated into French as well, so this could potentially result in less hits with regard to PROMIS and fracture patients, but no French articles were found in our search. In Australian literature, especially the use of PROMIS-29 and PROMIS 10 in for example the New South Wales Trauma Outcome Registry and Quality Evaluation (TORQUE) was promoted, but as far as our search reaches, no publications were generated from these reports [99, 100]. PROMIS-networks in other non-English speaking countries have also been established in for example the Netherlands and Belgium (Dutch-Flemish PROMIS group), and Germany (PROMIS® Germany). These PROMIS communities provide information about PROMIS, support development and translation of PROMIS measures and can advise or participate in new scientific projects. Yet, it has to be emphasized that the development and translation of PROMIS measures to languages other than English, needs to be continued for worldwide implementation. Especially the measurement and documentation of PROMS in low and -middle income countries (LMIC) in general, is running behind [101, 102]. In our case, articles including PROMIS measures and fracture patients from LMIC are absent, but the PROMIS Health Organization does show that PROMIS translations (in fixed length or CAT version) are available to every continent of the world . Barriers for the successful introduction and usage of PROMIS could possibly be found in more sophisticated technologies in the use of computer adaptive testing which may not be routinely available, but barriers of PROs in general could be linked to missing centralized documentation in EMR or financial support . We would therefore advocate to both scientists and clinicians to explore the possibilities of PROMIS within their own PROMIS communities for the prospects of PROMIS.
This systematic review has a few limitations. Firstly, articles were possibly missed during database search. But, by involving a professional librarian and by searching in five medical databases, we attempted to include all available articles. Furthermore, only English papers were included which theoretically increases the risk for language bias. Language bias is actually very limited, since only two papers were excluded due to the non-English language. Thirdly, only one reviewer independently extracted the data which could potentially cause information bias, but a second reviewer checked randomly for accuracy and supplemented if needed. Fourthly, the STROBE-checklist was used for the assessment of observational studies. However, originally it has been developed as a checklist for the report of observational studies, rather than a tool for methodological quality assessment . No universal consensus exists in the assessment of methodological quality of observational studies, but the use of the STOBE checklist does support in the knowledge and evaluation of observational papers [104, 105]. Furthermore we faced difficulties in the assessment of papers by use of the strobe checklist or by use of the care guidelines for case series. Multiple papers mentioned the term ‘case series’ in their abstract, but classified the paper in the main text as cohort study. As known from the literature, distinguishing cohort studies and case series might be difficult . Therefore, we only chose to assess papers by using the care guidelines for case series if the title or main text involved a description with the term case series. Lastly, readers should take into consideration that the upward trend of the use of PROMIS measures will probably increase, because results as shown in this paper apply until January 2021.
This review shows that the use of PROMIS measures in the field of orthopedic fracture care is increasing. Many different PROMIS measures on multiple domains are available and already used in previous articles for the evaluation of patient outcomes. With physical function and pain interference as most popular PROMIS measures, it is important to emphasize that other health-domains such as mental and social health can also be essential to fracture patients. PROMIS measures offer a valid, reliable and easy accessible tool to evaluate the patient as a whole and healthcare providers providing care for fracture patients (and scientists) could consider to connect to available national PROMIS-networks to learn more about the possibilities of PROMIS.
Availability of data and materials
Data are available from the authors upon reasonable request.
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Houwen, T., de Munter, L., Lansink, K.W.W. et al. There are more things in physical function and pain: a systematic review on physical, mental and social health within the orthopedic fracture population using PROMIS. J Patient Rep Outcomes 6, 34 (2022). https://doi.org/10.1186/s41687-022-00440-3
- Patient-reported outcomes