Abstract
Introduction
Patient-reported outcomes (PROs) are frequently utilized within orthopaedics to determine the extent of patient disease and the efficacy of surgical treatments. Shoulder arthroplasty is a common treatment option for a range of pathologies; however, substantial variety exists regarding the instruments used within the published literature, limiting their quality and generalizability. The purpose of the present systematic review is to evaluate the overall number and frequency of outcome measures used in all clinical studies evaluating outcomes following shoulder arthroplasty.
Methods
This systematic review was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Relevant studies that assessed patient reported outcomes following total shoulder arthroplasty, reverse shoulder arthroplasty, and shoulder hemiarthroplasty were obtained from PubMed, MEDLINE, and EMBASE databases. For each manuscript, the journal, authors, region of origin, level of evidence, and subject/pathology were recorded. The frequency of each reported outcome measure and category. Associations between study characteristics and measure categories were tested using Poisson regression with robust error variance.
Results
A total of 682 articles were included in the analysis, reporting 42 different PROs. The most popular tools were the Constant-Murley score (49.7%), the American Shoulder and Elbow Surgeons Evaluation Form (37.7%), and the Visual Analog Scale (34.3%). A generic outcome tool was used in 287 studies (42.1%), while 645 (94.6%) utilized a shoulder-specific measure and 49 (7.2%) used a disease-specific measure. The use of generic (p<0.001) and disease specific (p<0.001) measures were associated with higher level of evidence.
Conclusion
Studies assessing patient outcomes following shoulder arthroplasty employ a large range of PRO measuring tools, many of which are non-validated. Furthermore, only a small percentage of studies utilize a combination of tools from different categories despite current recommendations. Consensus on validated and clinically-meaningful tools from multiple categories is necessary to increase the generalizability and applicability of published studies in shoulder arthroplasty literature.
Level of Evidence
1
Keywords: patient-reported outcome measures, shoulder arthroplasty, patient reported outcomes, outcome measure
Introduction
As the current healthcare climate transitions towards value-based care, physician reimbursement will become increasingly reliant on patient-centered outcomes.1–3 In order to accurately assess the efficacy of medical treatments, appropriate instruments for measuring patient outcomes will be necessary.3,4 An effective patient outcome measurement tool should be valid, reproducible, and relevant to a given pathology.5,6 These tools should also be responsive when interventions are employed, detecting clinically meaningful differences as disease states change or improve.5,7 Measurement tools consisting of these qualities will allow for comparisons between studies and treatment interventions.
Orthopaedic literature has demonstrated increasing utilization of patient-reported outcome scores.3,8 Despite their prevalence, the outcome measurements employed within published studies have exhibited substantial variability. 6 There is poor consensus within the orthopaedic community regarding outcome instrument selection.9–12 This has been largely attributed to the wide range of metrics available and the uncertainty of any given tool's clinical utility.10,12 Due to inconsistencies in reported outcome measurement tools and the frequent use of inappropriate metrics among studies, some institutions and organizations have attempted to provide guidelines regarding their use.12–14 These recommendations have been created to improve the validity of published studies, subsequently allowing for better assessment and comparison of the effectiveness of different orthopaedic interventions.
Shoulder pain is a prevalent complaint within the general population and a common cause of morbidity and disability.15–17 Due to the substantial impact of shoulder pathologies on medical and societal costs, the development of effective and efficacious treatment options is imperative. Shoulder arthroplasty is a frequently utilized procedure for the treatment of a variety of shoulder pathologies; however, the literature demonstrating its benefit has exhibited limited generalizability and comparability due to the diversity of outcome measurement tools reported. 18 In order to improve the clinical applicability of these studies, a consolidation of outcome instruments will be necessary. By identifying the number and frequency of patient-reported outcome measures utilized in current literature, a standardized measuring tool can be created. As such, the purpose of this systematic review is to identify the number and frequency of outcome measures used in shoulder arthroplasty literature. The present study also aims to identify associations between publication characteristics and the type of outcome measurement tool utilized.
Materials and methods
Literature search and inclusion criteria
The present systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. All articles published relating to total shoulder arthroplasty (TSA), reverse total shoulder arthroplasty (rTSA), and shoulder hemiarthroplasty were identified via search of the PubMed and MEDLINE databases. The search strategy for publications regarding these procedures was ‘(((((shoulder arthroplasty) OR shoulder replacement) OR total shoulder) OR reverse shoulder) OR hemiarthroplasty) AND shoulder AND full text[sb] AND Humans[mesh]’. Only articles written in English were included in the study. Manual checks of reference lists in published articles were also performed.
All clinical studies reporting at least one patient reported outcome were included in the analysis. Review articles, non-human studies, biomechanical studies, cadaveric studies, and single case reports were excluded. Studies reporting outcomes of procedures other than shoulder arthroplasty were also excluded.
Data extraction and outcomes
Article title, year, author, journal, level of evidence, geographic region of origin, subject/pathology (i.e. arthritis, trauma, etc.) were recorded for all included studies. All PROMs reported within each study were also recorded.
Each measurement tool reported was then categorized as ‘Generic’ (e.g. Visual Analog Scale), ‘Region or Shoulder-specific’ (e.g. Disabilities of the Arm, Shoulder, and Hand [DASH]) or ‘Disease-Specific’ (e.g. Western Ontario Osteoarthritis of the Shoulder Score [WOOS]), as performed in previously published studies.11,12,19
Statistical analysis
Statistical analysis was performed using Stata/MP 13.1 for Mac (StataCorp LP, College Station, TX). Study characteristics and PROM frequency were analyzed using descriptive statistics, such as sums and percentages. Bivariate testing was performed via chi-square analysis for all categorical variables. Multivariate testing was performed via Poisson regression with robust error variance to determine associations between the recorded publication characteristics and the utilization of a specific patient reported outcome category. Statistical significance was accepted with p < 0.05.
Results
The initial search yielded a result of 8369 published articles. Following review of title and abstract, 711 were identified as having a clinical focus in shoulder arthroplasty. Following review of full text manuscripts and the application of exclusion criteria, 682 articles remained for final analysis. Figure 1 exhibits the PRISMA flowchart for the included publications.
Figure 1.
Flow diagram of included studies.
Table 1 summarizes the characteristics of the included studies. A total of 682 studies reporting at least one patient reported outcome following TSA, rTSA, or shoulder hemiarthroplasty were published between 1992 and 2018. Of these, 42.1% were published in the Journal of Shoulder and Elbow Surgery. The majority of studies (67.7%) were Level 4 evidence. Arthritis was the most common pathology, having been addressed in 36.7% of the included studies.
Table 1.
Characteristics of clinical publications (N = 682) a
| N | Percent of total (%) | |
|---|---|---|
| Overall | 682 | 100 |
| Journal | ||
| JBJS | 103 | 15.10 |
| JSES | 287 | 42.08 |
| CORR | 37 | 5.43 |
| International Orthopaedics | 37 | 5.43 |
| AOTS | 27 | 3.96 |
| The Bone and Joint Journal | 26 | 3.81 |
| Other | 165 | 24.19 |
| Level of evidence | ||
| 1 | 24 | 3.52 |
| 2 | 42 | 6.16 |
| 3 | 154 | 22.58 |
| 4 | 462 | 67.74 |
| Region of origin | ||
| North America | 332 | 46.68 |
| Asia | 22 | 3.23 |
| Europe/ME | 313 | 45.89 |
| South America | 15 | 2.20 |
| Subject matter | ||
| Arthritis | 250 | 36.66 |
| Trauma | 147 | 21.55 |
| Revision | 67 | 9.82 |
| Infection | 6 | 0.88 |
| Mixed | 212 | 31.09 |
JBJS: Journal of Bone and Joint Surgery; JSES: Journal of Shoulder and Elbow Surgery; CORR: Clinical Orthopaedics and Related Research; AOTS: Archives of Orthopaedic and Trauma Surgery.
aPublished studies assessing patient reported outcomes following total shoulder arthroplasty, reverse total shoulder arthroplasty, or shoulder hemiarthroplasty.
Tables 2 and 3 list all the reported generic outcome measures and the study characteristics associated with their use, respectively. A total of 287 (42.1%) studies reported a generic outcome measure. Amongst these studies, 10 unique generic outcome measures were utilized. The most frequently used generic outcome measure was the Visual Analog Scale (34.3%), followed by the Short Form-12 (5.0%) and the Short Form-36 (4.4%). Twenty-five (3.7%) studies utilized only generic outcome measure. Higher level of evidence was associated with the use of a generic outcome measure (p < 0.001). European studies were least likely to incorporate a generic outcome (p = 0.003).
Table 2.
Generic outcome measures utilized in published studies (N = 682).
| n | Percent of total (n/N) (%) | |
|---|---|---|
| Overall a | 287 | 42.08 |
| Visual Analog Scale | 234 | 34.31 |
| Short Form-12 | 34 | 4.99 |
| Short Form-36 | 30 | 4.40 |
| EuroQoL 5-Domain | 17 | 2.49 |
| Numeric Pain Rating Scale | 7 | 1.03 |
| HSS Scoring System | 2 | 0.29 |
| Global Rate of Change Scale | 2 | 0.29 |
| Health-Related Quality of Life | 2 | 0.29 |
| Likert-type Scale | 2 | 0.29 |
| Resiliency Score | 1 | 0.15 |
NRS Pain: Numeric Pain Rating Scale; HSS: Hospital for Special Surgery.
aPercent of total studies using generic outcome measures.
Table 3.
Study characteristics associated with use of generic outcome measures.
| n/N | Percent of total (%) a | p value b | |
|---|---|---|---|
| Overall | 287/682 | 42.08 | – |
| Journal | 0.773 | ||
| JBJS | 33/103 | 32.04 | |
| JSES | 127/287 | 44.25 | |
| CORR | 14/37 | 37.84 | |
| International Orthopaedics | 19/37 | 51.35 | |
| AOTS | 9/27 | 33.33 | |
| The Bone and Joint Journal | 12/26 | 46.15 | |
| Other | 73/165 | 44.24 | |
| Level of evidence | <0.001 | ||
| 1 | 16/24 | 66.67 | |
| 2 | 20/42 | 47.62 | |
| 3 | 76/154 | 49.35 | |
| 4 | 175/462 | 37.88 | |
| Region of origin | 0.003 | ||
| North America | 166/332 | 50.00 | |
| Asia | 13/22 | 59.09 | |
| Europe/ME | 99/313 | 31.63 | |
| South America | 9/15 | 60.00 | |
| Subject matter | 0.301 | ||
| Arthritis | 100/250 | 40.00 | |
| Trauma | 62/147 | 42.18 | |
| Revision | 28/67 | 41.79 | |
| Infection | 1/6 | 16.67 | |
| Mixed | 96/116 | 45.28 |
JBJS: Journal of Bone and Joint Surgery; JSES: Journal of Shoulder and Elbow Surgery; CORR: Clinical Orthopaedics and Related Research; AOTS: Archives of Orthopaedic and Trauma Surgery; ME: Middle East.
Boldface indicates statistical significance.
aPercent of studies with a specific characteristic utilizing a generic outcome measure.
bp value was calculated for each category using Poisson regression with robust error variance (categorical).
Tables 4 and 5 list the reported shoulder-specific outcome measures and the study characteristics associated with their use. A total of 645 (94.6%) studies reported a shoulder-specific outcome measure. Amongst these studies, 23 unique shoulder-specific outcome measures were utilized. The most frequently used shoulder-specific outcome measure was the CMS (49.7%), followed by the American Shoulder and Elbow Surgeon Evaluation Form (37.7%) and the Simple Shoulder Test (21.6%); 357 (52.2%) studies reported only shoulder-specific outcome measures. No study characteristics were associated with the use of a shoulder-specific outcome score.
Table 4.
Shoulder-specific outcome measures utilized in published studies (N = 682).
| n | Percent of total (n/N) (%) | |
|---|---|---|
| Overall a | 645 | 94.57 |
| Constant–Murley Score | 343 | 49.71 |
| ASES Evaluation Form | 257 | 37.68 |
| Simple Shoulder Test | 147 | 21.55 |
| Modified Neer Pain Scale | 78 | 11.45 |
| DASH | 78 | 11.44 |
| Subjective Shoulder Value | 77 | 11.29 |
| Neer Pain Scale | 55 | 8.06 |
| UCLA Shoulder Score | 42 | 6.16 |
| Oxford Shoulder Score | 41 | 6.01 |
| Shoulder Pain and Disability Index | 23 | 3.37 |
| Penn Shoulder Score | 20 | 2.93 |
| ADLER Score | 4 | 0.59 |
| L'Insalata Shoulder Score | 3 | 0.44 |
| Swanson Shoulder Scoring System | 2 | 0.29 |
| Shoulder Activity Scale | 2 | 0.29 |
| SSC Modification for Hemiarthroplasty | 1 | 0.15 |
| Korean Shoulder Scoring System | 1 | 0.15 |
| Japanese Orthopedic Association Score | 1 | 0.15 |
| Marx Shoulder Activity Score | 1 | 0.15 |
| Florida Impairment Guidelines | 1 | 0.15 |
| HSS Shoulder Surgery Expectations Survey | 1 | 0.15 |
| Objective Outcome Summary Score | 1 | 0.15 |
| Subjective Assessment of Shoulder Function | 1 | 0.15 |
aPercent of total studies using shoulder-specific outcome measures.
UCLA: University of California: Los Angeles; DASH: Disabilities of the Arm, Shoulder, and Hand; ASES: American Shoulder and Elbow Surgeons; ADLER: Activities of Daily Living Requiring External Rotation; SSC: Scoring System for Cases; HSS: Hospital for Special Surgery.
Table 5.
Study characteristics associated with use of shoulder-specific outcome measures.
| n/N | Percent of total (%) a | p value b | |
|---|---|---|---|
| Overall | 645/682 | 94.57 | – |
| Journal | 0.094 | ||
| JBJS | 101/103 | 98.06 | |
| JSES | 277/287 | 96.52 | |
| CORR | 36/37 | 97.30 | |
| International Orthopaedics | 37/37 | 100.00 | |
| AOTS | 26/27 | 96.30 | |
| The Bone and Joint Journal | 23/26 | 88.46 | |
| Other | 145/165 | 87.88 | |
| Level of evidence | 0.396 | ||
| 1 | 22/24 | 91.67 | |
| 2 | 40/42 | 95.24 | |
| 3 | 143/154 | 92.86 | |
| 4 | 440/462 | 95.24 | |
| Region of origin | 0.746 | ||
| North America | 313/332 | 94.28 | |
| Asia | 20/22 | 90.91 | |
| Europe/ME | 298/313 | 95.21 | |
| South America | 14/15 | 93.33 | |
| Subject matter | 0.300 | ||
| Arthritis | 234/250 | 93.60 | |
| Trauma | 145/147 | 98.64 | |
| Revision | 65/67 | 97.01 | |
| Infection | 6/6 | 100.00 | |
| Mixed | 195/212 | 91.98 |
JBJS: Journal of Bone and Joint Surgery; JSES: Journal of Shoulder and Elbow Surgery; CORR: Clinical Orthopaedics and Related Research; AOTS: Archives of Orthopaedic and Trauma Surgery; ME: Middle East.
Statistical significance is p<.05.
aPercent of studies with a specific characteristic utilizing a shoulder-specific outcome measure.
bp value was calculated for each category using Poisson regression with robust error variance (categorical).
Tables 6 and 7 list the disease-specific outcome measure reported in the included studies and the study characteristics associated with their use. A total of 49 (7.2%) studies reported a disease-specific outcome measure. Among these studies, nine different disease-specific outcome measurement tools were utilized. The most common disease-specific tool was the Western Ontario Osteoarthritis of the Shoulder score (5.3%), followed by the Musculoskeletal Tumor Society Score (1.2%). Eleven (1.6%) studies reported only a disease-specific outcome measure.
Table 6.
Disease-specific outcome measures utilized in published studies (N = 682).
| n | Percent of total (n/N) (%) | |
|---|---|---|
| Overall a | 49 | 7.18 |
| Western Ontario OA of the Shoulder | 36 | 5.28 |
| MSK Tumor Society Score | 8 | 1.17 |
| Modified HAQ – Rheumatoid Arthritis | 2 | 0.29 |
| Toronto Extremity Salvage Score | 2 | 0.29 |
| Oxford SI Index | 1 | 0.15 |
| Rowe Score | 1 | 0.15 |
| Western Ontario SI Index | 1 | 0.15 |
| McMaster-Toronto Arthritis PPDQ | 1 | 0.15 |
| RA Disease Activity | 1 | 0.15 |
SI: shoulder instability; OA: osteoarthritis; PPDQ: Patient Preference Disability Questionnaire; HAQ: Health Assessment Questionnaire; MSK: musculoskeletal.
aPercent of total studies using disease-specific outcome measures.
Table 7.
Study characteristics associated with use of disease-specific outcome measures.
| n/N | Percent of total (%) a | p value b | |
|---|---|---|---|
| Overall | 49/682 | 7.18 | – |
| Journal | 0.585 | ||
| JBJS | 3/103 | 2.91 | |
| JSES | 20/287 | 6.97 | |
| CORR | 3/37 | 8.11 | |
| International Orthopaedics | 2/37 | 5.41 | |
| AOTS | 2/27 | 7.41 | |
| The Bone and Joint Journal | 2/26 | 7.69 | |
| Other | 17/165 | 10.30 | |
| Level of evidence | <0.001 | ||
| 1 | 4/24 | 16.67 | |
| 2 | 9/42 | 21.43 | |
| 3 | 15/154 | 9.74 | |
| 4 | 21/462 | 4.55 | |
| Region of origin | 0.257 | ||
| North America | 26/332 | 7.83 | |
| Asia | 2/22 | 9.09 | |
| Europe/ME | 21/313 | 6.71 | |
| South America | 0/15 | 0.00 | |
| Subject matter | 0.159 | ||
| Arthritis | 30/220 | 12.00 | |
| Trauma | 3/147 | 2.04 | |
| Revision | 1/67 | 1.49 | |
| Infection | 1/6 | 16.67 | |
| Mixed | 14/198 | 6.60 |
JBJS: Journal of Bone and Joint Surgery; JSES: Journal of Shoulder and Elbow Surgery; CORR: Clinical Orthopaedics and Related Research; AOTS: Archives of Orthopaedic and Trauma Surgery; ME: Middle East.
Boldface indicates statistical significance.
aPercent of studies with a specific characteristic utilizing a disease-specific outcome measure.
bp value was calculated for each category using Poisson regression with robust error variance (categorical).
Higher level of evidence was associated with the use of a disease-specific outcome measure (p < 0.001).
Table 8 reports the number of studies utilizing multiple outcome measures; 62 (9.09%) studies used two or more generic outcome measures, 389 (57.0%) studies used two or more shoulder-specific outcome measures, while only 5 (0.7%) studies used two or more disease-specific measures. Additionally, 262 (38.4%) studies reported a combination of generic and shoulder-specific outcome measures, and 11 (1.6%) studies reported a combination of generic and disease-specific outcome measures.
Table 8.
Studies using multiple outcome measures.
| n | Percent of total (n/N) (%) | |
|---|---|---|
| Overall | 682 | |
| Generic outcome | ||
| 1 | 243 | 35.63 |
| 2 | 58 | 8.50 |
| 3+ | 4 | 0.59 |
| Shoulder-specific outcome | ||
| 1 | 256 | 37.54 |
| 2 | 281 | 41.20 |
| 3+ | 108 | 15.84 |
| Disease-specific outcome | ||
| 1 | 44 | 6.45 |
| 2 | 5 | 0.73 |
| Combination | ||
| Gen+Shoulder | 262 | 38.42 |
| Gen+Disease | 11 | 1.61 |
| Shoulder+Disease | 35 | 5.13 |
Gen+Shoulder: studies using both a general outcome measure and a shoulder-specific outcome measure; Gen+Disease: studies using both a general outcome measure and a disease-specific outcome measure; Shoulder+Disease: studies using both a shoulder-specific outcome measure and a disease-specific outcome measure.
Discussion
The results of the present study demonstrate that 42 different PROMs have been utilized to quantify patient results in published shoulder arthroplasty literature. The majority of these studies reported a shoulder-specific outcome measure. The CMS is the most commonly utilized tool; however, less than half of the included studies utilized this score. The next most frequently utilized instruments were the American Shoulder and Elbow Surgeons Evaluation form followed by the Visual Analog Scale. Disease-specific outcome measures were infrequently reported and less than half of studies utilized measures from two different categories. Additionally, higher level of evidence was associated with the use of disease-specific and generic outcome measures.
The present study suggests that a wide range of outcome metrics have been reported in the current shoulder arthroplasty literature with no clear consensus on any given PROM. These results are consistent with other studies performed in the orthopaedic literature. In a review of published randomized controlled trials investigating the effect of either operative or nonoperative treatments in a variety of shoulder pathologies, Page et al. 20 identified 42 different PROMs reported among included studies. The authors also noted large discrepancies in the outcomes being addressed or measured within each tool. Similarly, in a systematic review assessing the quality of shoulder-specific outcome tools in published literature, Schmidt et al. 21 identified 11 unique shoulder-specific tools reported among 112 articles, each with varying quality and validity. PROM utilization has been promoted through initiatives such as the Patient Centered Outcomes Research Institute in attempts to improve healthcare quality, create evidence-based treatment recommendations, and reduce healthcare costs.20,22,23 However, there remains substantial variation in PROM selection, partially attributed to uncertainty among physicians regarding the utility of any given tool. 24 This lack of consensus limits study comparability and the assessment of treatment efficacy. As such, standardization of outcome measures is necessary to improve the generalizability, validity, and quality of shoulder arthroplasty and other orthopaedic literature.
Although there is little consistency amongst studies regarding employed PROMs, there are apparent trends in the shoulder arthroplasty literature. The present study identified the CMS being utilized in approximately 50% of included manuscripts. Previous studies assessing the score's popularity have demonstrated similar results. In the previously mentioned review by Page et al., 20 CMS was employed in 31% of the 409 included randomized controlled trials. In a review of all shoulder-related publications utilizing PROMs in four major orthopaedic journals published between 2012 and 2013, Booker et al. 18 noted that CMS was reported in approximately 52% of included studies. However, despite its popularity, multiple concerns have been raised regarding the score's utility, reliability, and clinical application.25–28
The CMS is a 100-point scale, incorporating both patient-reported and physician-measured components including pain, range of motion, and strength. 29 The score originally exhibited many flaws including utilization of an inappropriate pain scale and omitting questions assessing activities of daily living. 28 Although the score has since been revised, studies continue to report a mix of original and revised CMS values.28,30 Additionally, the scoring system has exhibited poor interobserver reliability, primarily attributed to variation in physical exam technique and methods in patient questioning.31–33 While valid and acceptable in some settings, the current evidence does not support the use of CMS as a gold standard evaluation tool for all shoulder pathologies, including osteoarthritis.26,28,34–36 As such, the standardization of this tool is necessary to improve the validity and the clinical utility of studies endorsing its use.
Despite the limitations in popular shoulder-specific outcomes, the present study's results demonstrate an infrequent utilization of validated disease-specific outcome measures. Many disease-specific outcome measures have been developed and validated to adequately capture a patient's progression along the spectrum for a particular disease; however, these tools are scarcely employed. 7 This has been attributed to the wide range of indications for shoulder arthroplasty, the poor generalizability of these tools to different pathologies, and the lack of instruments for all pathologies. 7 However, even studies addressing pathologies with valid and easily attainable outcome measures rarely incorporated these tools. In the present study, over a third of the included publications addressed arthritis. Despite this, only 5% utilized the validated Western Ontario Osteoarthritis of the Shoulder score.37,38 Furthermore, only 7% of all studies reported a disease-specific measure to supplement either a reported generic outcome or a shoulder-specific outcome. The International Consortium for Health Outcomes Measurement recommend the use of both a generic and disease-specific outcome measure for hip and knee arthroplasty research.12,13 Currently, no recommendations exist for shoulder arthroplasty literature, likely contributing to inappropriate PROM utilization and poor consensus among studies. As such, guidelines must be developed to encourage the use of a core set of valid outcome measures and improve the quality of shoulder arthroplasty literature.
Several study characteristics were associated with the utilization of generic, shoulder-specific, or disease-specific outcome measure in the present study. Specifically, higher level of evidence was associated with the use of generic and disease-specific outcome measures. This may be due to higher level studies employing more stringent methods with valid metrics to appropriately quantify patient outcomes and improve the clinical utility of the results. 6 By incorporating both a generic and disease-specific PROM, a patient's improvement along a particular pathology's spectrum can be monitored while also assessing the effect of the symptoms on daily living, functionality, and overall wellbeing. While this may not be possible for all studies due to number of tools needed to address all indications shoulder arthroplasty, this could be used as a guideline for high-level studies to improve the quality, generalizability, and clinical utility of their results.
This systematic review is not without limitations. First, although the review was performed in accordance with PRISMA guidelines, there is the possibility that some shoulder arthroplasty studies were inadvertently missed. Despite this, a large number of relevant studies were included in the study, providing an appropriate overview of the current status of PROMs used in shoulder arthroplasty literature. Second, the current systematic review only included studies relating to three specific procedures, as such, the results cannot be generalized to all shoulder literature. However, the reporting variability that existed within the present study may be indicative of an issue that is present across studies addressing other shoulder procedures as well.
Conclusion
The utilization of patient-reported outcomes in orthopaedic literature is becoming increasingly popular as healthcare transitions towards a value-based system.1,2,23 Despite government and institutional efforts to promote the incorporation of PROMs in both clinical and research settings, no consensus has been reached regarding the most appropriate outcome tools. 23 The present study demonstrates substantial variability in the outcome measures reported within shoulder arthroplasty literature. These results highlight a need for the consolidation of outcome tools employed in orthopaedic research. Strict guidelines with standardized outcome measures will be necessary in order to improve the validity, quality, and clinical utility of shoulder arthroplasty studies and other orthopaedics-related research.
Footnotes
Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding: The author(s) received no financial support for the research, authorship, and/or publication of this article.
Guarantor: FH
Contributorship: AS, FH, and IV conceived the study and researched literature. BS and TC were in charge of literature research and review of literature for data retrieval. FH was in charge of data analysis. FH was in charge of writing the first draft of the manuscript. All authors reviewed and edited the manuscript and approved the final version of the manuscript.
ORCID iD: Blake M Schach https://orcid.org/0000-0002-6864-0640
References
- 1.Gabriel SE, Normand SL. Getting the methods right – the foundation of patient-centered outcomes research. N Engl J Med 2012; 367: 787–790. [DOI] [PubMed] [Google Scholar]
- 2.Orszag PR, Ellis P. Addressing rising health care costs – a view from the Congressional Budget Office. N Engl J Med 2007; 357: 1885–1887. [DOI] [PubMed] [Google Scholar]
- 3.Poolman RW, Swiontkowski MF, Fairbank JC, et al. Outcome instruments: rationale for their use. J Bone Joint Surg Am 2009; 91: 41–49. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4.Marshall S, Haywood K, Fitzpatrick R. Impact of patient-reported outcome measures on routine practice: a structured review. J Eval Clin Pract 2006; 12: 559–568. [DOI] [PubMed] [Google Scholar]
- 5.Bhandari M, Giannoudis PV. Assessing patient outcomes: pearls for clinical practice and research. Injury 2011; 42: 231. [DOI] [PubMed] [Google Scholar]
- 6.Zlowodzki M, Bhandari M. Outcome measures and implications for sample-size calculations. J Bone Joint Surg Am 2009; 91: 35–40. [DOI] [PubMed] [Google Scholar]
- 7.Farrugia P, Goldstein C, Petrisor BA. Measuring foot and ankle injury outcomes: common scales and checklists. Injury 2011; 42: 276—280. [DOI] [PubMed] [Google Scholar]
- 8.Swiontkowski MF, Buckwalter JA, Keller RB, et al. The outcomes movement in orthopaedic surgery: where we are and where we should go. J Bone Joint Surg Am 1999; 81: 732–740. [DOI] [PubMed] [Google Scholar]
- 9.Cutler HS, Guzman JZ, Al Maaieh M, et al. Patient reported outcomes in adult spinal deformity surgery: a bibliometric analysis. Spine Deform 2015; 3: 312–317. [DOI] [PubMed] [Google Scholar]
- 10.Guzman JZ, Cutler HS, Connolly J, et al. Patient-reported outcome instruments in spine surgery. Spine 2016; 41: 429–437. [DOI] [PubMed] [Google Scholar]
- 11.Hunt KJ, Hurwit D. Use of patient-reported outcome measures in foot and ankle research. J Bone Joint Surg Am 2013; 95: e118(1–9). [DOI] [PubMed] [Google Scholar]
- 12.Lovelock TM, Broughton NS, Williams CM. The popularity of outcome measures for hip and knee arthroplasties. J Arthroplasty 2018; 33: 273–276. [DOI] [PubMed] [Google Scholar]
- 13.Rolfson O, Bohm E, Franklin P, et al. Patient-reported outcome measures in arthroplasty registries. Report of the Patient-Reported Outcome Measures Working Group of the International Society of Arthroplasty Registries Part II. Recommendations for selection, administration, and analysis. Acta Orthop 2016; 87: 9–23. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 14.Rolfson O, Wissig S, van Maasakkers L, et al. Defining an International Standard Set of Outcome Measures for Patients with Hip or Knee Osteoarthritis: Consensus of the International Consortium for Health Outcomes Measurement Hip and Knee Osteoarthritis Working Group. Arthritis Care Res 2016; 68: 1631–1639. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 15.Largacha M, Parsons IMt, Campbell B, et al. Deficits in shoulder function and general health associated with sixteen common shoulder diagnoses: a study of 2674 patients. J Shoulder Elbow Surg 2006; 15: 30–39. [DOI] [PubMed] [Google Scholar]
- 16.van der Heijden GJ. Shoulder disorders: a state-of-the-art review. Baillieres Best Pract Res Clin Rheumatol 1999; 13: 287–309. [DOI] [PubMed] [Google Scholar]
- 17.Virta L, Joranger P, Brox JI, et al. Costs of shoulder pain and resource use in primary health care: a cost-of-illness study in Sweden. BMC Musculoskelet Disord 2012; 13: 17. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 18.Booker S, Alfahad N, Scott M, et al. Use of scoring systems for assessing and reporting the outcome results from shoulder surgery and arthroplasty. World J Orthop 2015; 6: 244–251. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 19.Hijji FY, Schneider AD, Pyper M, et al. The popularity of outcome measures used in the foot and ankle literature. Foot Ankle Spec 2020; 13: 58–68. [DOI] [PubMed] [Google Scholar]
- 20.Page MJ, Huang H, Verhagen AP, et al. Outcome reporting in randomized trials for shoulder disorders: literature review to inform the development of a core outcome set. Arthritis Care Res 2018; 70: 252–259. [DOI] [PubMed] [Google Scholar]
- 21.Schmidt S, Ferrer M, Gonzalez M, et al. Evaluation of shoulder-specific patient-reported outcome measures: a systematic and standardized comparison of available evidence. J Shoulder Elbow Surg 2014; 23: 434–444. [DOI] [PubMed] [Google Scholar]
- 22.Linsell L, Dawson J, Zondervan K, et al. Prevalence and incidence of adults consulting for shoulder conditions in UK primary care; patterns of diagnosis and referral. Rheumatology 2006; 45: 215–221. [DOI] [PubMed] [Google Scholar]
- 23.Tunis SR, Clarke M, Gorst SL, et al. Improving the relevance and consistency of outcomes in comparative effectiveness research. J Comp Eff Res 2016; 5: 193–205. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 24.Hunt KJ, Lakey E. Patient-reported outcomes in foot and ankle surgery. Orthop Clin North Am 2018; 49: 277–289. [DOI] [PubMed] [Google Scholar]
- 25.Blonna D, Scelsi M, Marini E, et al. Can we improve the reliability of the Constant–Murley score?. J Shoulder Elbow Surg 2012; 21: 4–12. [DOI] [PubMed] [Google Scholar]
- 26.Conboy VB, Morris RW, Kiss J, et al. An evaluation of the Constant–Murley shoulder assessment. J Bone Joint Surg Br 1996; 78: 229–232. [PubMed] [Google Scholar]
- 27.Kirkley A, Griffin S, Dainty K. Scoring systems for the functional assessment of the shoulder. Arthroscopy 2003; 19: 1109–1120. [DOI] [PubMed] [Google Scholar]
- 28.Vrotsou K, Avila M, Machon M, et al. Constant–Murley Score: systematic review and standardized evaluation in different shoulder pathologies. Qual Life Res 2018; 27: 2217–2226. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 29.Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res 1987; 214: 160–164. [PubMed] [Google Scholar]
- 30.Constant CR, Gerber C, Emery RJ, et al. A review of the Constant score: modifications and guidelines for its use. J Shoulder Elbow Surg 2008; 17: 355–361. [DOI] [PubMed] [Google Scholar]
- 31.Bankes MJ, Crossman JE, Emery RJ. A standard method of shoulder strength measurement for the Constant score with a spring balance. J Shoulder Elbow Surg 1998; 7: 116–121. [DOI] [PubMed] [Google Scholar]
- 32.Lillkrona U. How should we use the Constant Score? – A commentary. J Shoulder Elbow Surg 2008; 17: 362–363. [DOI] [PubMed] [Google Scholar]
- 33.Rocourt MH, Radlinger L, Kalberer F, et al. Evaluation of intratester and intertester reliability of the Constant–Murley shoulder assessment. J Shoulder Elbow Surg 2008; 17: 364–369. [DOI] [PubMed] [Google Scholar]
- 34.Baker P, Nanda R, Goodchild L, et al. A comparison of the Constant and Oxford shoulder scores in patients with conservatively treated proximal humeral fractures. J Shoulder Elbow Surg 2008; 17: 37–41. [DOI] [PubMed] [Google Scholar]
- 35.Huang H, Grant JA, Miller BS, et al. A systematic review of the psychometric properties of patient-reported outcome instruments for use in patients with rotator cuff disease. Am J Sports Med 2015; 43: 2572–2582. [DOI] [PubMed] [Google Scholar]
- 36.Slobogean GP, Slobogean BL. Measuring shoulder injury function: common scales and checklists. Injury 2011; 42: 248–252. [DOI] [PubMed] [Google Scholar]
- 37.Klintberg IH, Lind K, Marlow T, et al. Western Ontario Osteoarthritis Shoulder (WOOS) index: a cross-cultural adaptation into Swedish, including evaluation of reliability, validity, and responsiveness in patients with subacromial pain. J Shoulder Elbow Surg 2012; 21: 1698–1705. [DOI] [PubMed] [Google Scholar]
- 38.St-Pierre C, Dionne CE, Desmeules F, et al. Reliability, validity, and responsiveness of a Canadian French adaptation of the Western Ontario Rotator Cuff (WORC) index. J Hand Ther 2015; 28: 292–298. [DOI] [PubMed] [Google Scholar]