The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 94, Issue 17

Scientific Articles | September 05, 2012

Impact of Total Shoulder Arthroplasty on Generic and Shoulder-Specific Health-Related Quality-of-Life Measures: A Systematic Literature Review and Meta-Analysis

Michael J. Carter, MD¹; Ted R. Mikuls, MD, MSPH¹; Smita Nayak, MD²; Edward V. Fehringer, MD³; Kaleb Michaud, PhD¹

¹ University of Nebraska Medical Center, 986270 Nebraska Medical Center, Omaha, NE 68198-6270. E-mail address for K. Michaud: kmichaud@unmc.edu
² University of Pittsburgh, 200 Meyran Avenue, Suite 200, Pittsburgh, PA 15213
³ Nebraska Arthritis Outcomes Research Center & University of Nebraska Medical Center, 981080 Nebraska Medical Center, Omaha, NE 68198-1080

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Investigation performed at the University of Nebraska Medical Center, Omaha, Nebraska

J Bone Joint Surg Am, 2012 Sep 05;94(17):e127 1-9. doi: 10.2106/JBJS.K.00204

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Abstract

Background:

Total shoulder arthroplasty is increasingly used in the treatment of arthritis. However, the effect of total shoulder arthroplasty on health-related quality of life has not been fully established. The goal of this systematic review and meta-analysis was to characterize the change in generic and shoulder-specific health-related quality-of-life measures resulting from total shoulder arthroplasty.

Methods:

We identified published studies reporting preoperative and postoperative health-related quality-of-life outcomes for patients receiving total shoulder arthroplasty. Health-related quality-of-life measures were identified, and meta-analysis was used to calculate standardized mean differences (SMDs, reflective of the effect size) and 95% confidence intervals for each scale.

Results:

Twenty studies (1576 total shoulder replacements) met the inclusion criteria. Outcome measures were analyzed after an average postoperative follow-up duration of 3.7 ± 2.2 years. The Short Form-36 demonstrated significant improvement in physical component summary scores (SMD = 0.7, p < 0.001) but not in mental component summary scores (SMD = 0.2, p = 0.37). Significant improvements were observed in the visual analog scale score for pain (SMD = −2.5, p < 0.001) and scores on three shoulder-specific measures: the Constant score (SMD = 2.7, p < 0.001), American Shoulder and Elbow Surgeons score (SMD = 2.9, p < 0.001), and Simple Shoulder Test (SMD = 2.3, p < 0.001).

Conclusions:

Total shoulder arthroplasty leads to significant improvements in scores for function and pain. Shoulder-specific measures of function consistently showed the greatest degree of improvement, with large effect sizes. Total shoulder arthroplasty also leads to significant improvements in overall physical well-being, with a moderate-to-large effect size.

Level of Evidence:

Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Figures in this Article

Introduction

Over the last thirty-five years, the use of total shoulder arthroplasty for treatment of end-stage glenohumeral arthritis has increased dramatically¹. During the 1990s alone, the frequency of total shoulder arthroplasty increased by almost 40% among individuals over sixty-five years of age in the U.S.². Although several studies have demonstrated health-related quality-of-life benefits of total shoulder arthroplasty with use of generic and shoulder-specific measures, the magnitude of benefit gained from total shoulder arthroplasty has not been well defined. With rare exception, studies examining the impact of total shoulder arthroplasty on health outcomes have been performed at single centers and have involved a limited number of both surgeons and patients. Additionally, there has been little consensus regarding which health outcomes should be measured in the context of total shoulder arthroplasty. Many scoring systems were developed before appropriate methods were available to establish their validity³, and new or modified outcome measures have often been used in assessments of total shoulder arthroplasty⁴. Despite the introduction of several validated scales in the 1990s, there remains no definitive, universally adopted measure of health outcomes for evaluation of total shoulder arthroplasty.

A precise estimate of the effect of total shoulder arthroplasty on health-related quality of life will be necessary as part of any future cost-effectiveness considerations. Moreover, establishing the baseline benefit from total shoulder arthroplasty will be central to any future evaluations exploring the incremental gains resulting from modifications or other advances in surgical technique. The goal of this systematic review and meta-analysis was to identify the generic and shoulder-specific health-related quality-of-life outcome measures used in studies of total shoulder arthroplasty, establish those that are most frequently used, and characterize the change in each measure that can be expected as a result of the procedure.

Materials and Methods

Data Sources and Searches

A PubMed search of the MEDLINE and Cochrane Collaboration databases for articles published between the origin of MEDLINE in 1966 and June 1, 2009, was performed with use of the search terms listed in the Appendix. An Embase search was also performed, encompassing articles published from the origin of Embase in 1974 to the same end date as the MEDLINE search (June 1, 2009). The terms used to execute the Embase search are also listed in the Appendix. This search was developed and performed with the assistance of research librarians. To be as inclusive as possible, a large number of terms were included in the search string, including Medical Subject Headings (MeSH) and text words pertaining to the shoulder, procedure/hardware, outcomes of interest, and study design. In addition, an orthopaedic surgeon with expertise in total shoulder arthroplasty provided additional input on potentially relevant articles. Review articles and book chapters related to shoulder arthroplasty were identified within the search results, and all references from these sources were evaluated for potential inclusion. All references of studies meeting the inclusion criteria were similarly examined.

Study Selection

Inclusion criteria for articles identified by the search were: (1) inclusion of patients who underwent primary total shoulder arthroplasty with an unconstrained prosthesis with synthetic humeral and glenoid components; (2) surgical indications specified as glenohumeral arthritis, except for specifically excluded types; and (3) reported preoperative and postoperative health-related quality-of-life outcome measures with at least six months of follow-up. Studies containing a separate treatment group, such as hemiarthroplasty, were included if the outcomes for total shoulder arthroplasty were reported separately; only total shoulder arthroplasty outcomes were analyzed. Health-related quality-of-life measures encompass primary domains of health, such as pain, function, and/or physical and emotional well-being, that are responsive to the treatment of interest. Studies that presented results of both shoulders in the same patient were included, as were patients with minor, reparable rotator cuff tears and/or inflammatory arthritis. No studies were excluded on the basis of patient characteristics, including age, sex, race/ethnicity, socioeconomic status, glenoid morphology, or comorbid disease status. Studies were not required to specify the attrition rate, hospital volume, surgeon quality, or whether concomitant biceps tenodesis had been performed.

Studies were excluded if (1) there were ten or fewer patients; (2) surgical indications included rotator cuff tear arthropathy, rotator cuff deficiency, traumatic injuries, osteonecrosis of the humeral head, capsulorrhaphy arthropathy, instability arthropathy, tumors or bone resection for oncologic treatment, or septic arthritis or another infectious etiology; (3) patients received other types of joint replacement (e.g., knee or elbow) simultaneously; (4) patients did not receive synthetic components; (5) data presented were duplicative with those of an earlier publication; or (6) the report was not in the English language. Studies that provided only aggregate results of both total shoulder arthroplasty and hemiarthroplasty were excluded. One study⁵ included a single patient with a surgical indication of fresh fracture; since the other 137 patients met the inclusion criteria, the study was included in our meta-analysis. Another study⁶ included a single shoulder with a diagnosis of capsulorrhaphy arthropathy; the other twenty-five shoulders met the inclusion criteria, and this study was also included. Rotator cuff deficiency was considered to encompass large or irreparable rotator cuff tears, whether diagnosed preoperatively or intraoperatively.

All inclusion and exclusion criteria were reviewed by a fellowship-trained shoulder orthopaedic surgeon (E.V.F.) with ten years of clinical experience in total shoulder arthroplasty. All articles identified with the search strategy were evaluated for inclusion by the lead author (M.J.C.), and any articles that were not clearly included or excluded were refereed by the same orthopaedic surgeon (E.V.F.) for surgery-specific issues, or by the supporting experienced authors for statistical or methodological issues. One of these experienced authors (T.R.M.) is a rheumatologist with more than ten years of clinical experience, along with an MSPH and ten years of extensive experience with outcomes research. Another experienced author (K.M.) has a PhD, has been epidemiologically trained, and is an author of eighty-five papers published in the past decade.

Data Extraction and Evidence Assessment

Information relevant to each report, including publication year, study location, method of patient selection, level of evidence as assessed according to The Journal of Bone and Joint Surgery Instructions for Authors⁷, number of patients and shoulders examined, attrition, preoperative and postoperative health-related quality-of-life measures (generic and shoulder-specific), preoperative diagnosis, average patient age, minimum and average follow-up time, patient demographics, operating surgeon, and funding source, was abstracted. The significance of any study findings was noted, as were any references to surgical techniques used. Sources of potential bias with regard to patient selection and allocation of treatment, or other evidence of bias arising from study design or data collection, were recorded. The frequency of reoperations, when reported, was also recorded. Complications and adverse outcomes were accounted for through their effect on aggregate outcomes data, and were included in the standard analysis of outcomes. In many cases, the authors of the studies did not detail complications according to the specific patient group, so it was not possible to accurately characterize complications beyond their effect on aggregate health-related quality-of-life outcome measures as reported for each patient group.

Data Synthesis and Analysis

All analyses were performed with use of Review Manager 5.0⁸, a meta-analysis program provided by the Cochrane Collaboration. The number of shoulders was used as the group size (n) for each study, as the number of patients was less often reported for specific treatment groups. All health-related quality-of-life measures were treated as continuous variables, and Cohen’s d was used to estimate effect size from individual studies. Cohen’s d expresses the size of the treatment effect in each study relative to the variability within that study (a standardized mean difference [SMD]); this standardizes the results of studies that use different scales to measure the same outcome, so that they can be combined⁹. For each outcome measure, the chi-square test statistic for heterogeneity (Q) and I² values were calculated to evaluate for heterogeneity between studies. I² is derived directly from the Q statistic and is given as a percentage, with increasing values indicating increasing heterogeneity. General guidelines suggest that I² values of 25%, 50%, and 75% indicate low, medium, and high heterogeneity, respectively¹⁰. Random effects models were used for meta-analysis because of observed heterogeneity in the collected data; random effects models provide a more conservative estimate of treatment effect than do fixed effects models¹¹. Forest plots were generated for each of the outcome measures, displaying individual study SMDs (equivalent to effect size) and corresponding 95% confidence intervals (CIs), individual study weights, and overall summary effect size and 95% CI. For studies not reporting standard deviations (SDs) for a given outcome, the missing SD was imputed with use of the mean value across studies in which the SD was reported. Effect size was defined as the difference in the outcome (after total shoulder arthroplasty minus before total shoulder arthroplasty) divided by the SD of the lagged outcome (after total shoulder arthroplasty), and was considered small if it was <0.5 and ≥0.2, moderate if it was <0.8 and ≥0.5, and large if it was ≥0.8¹². Sensitivity analysis was performed by removing individual studies from analysis and determining if this resulted in a significant change in treatment effect. P values were required to be ≤0.05 to indicate significance.

Source of Funding

This study was supported by the Nebraska Arthritis Outcomes Research Center and the University of Nebraska Medical Center Enhanced Medical Education Track (EMET). Kaleb Michaud received funding from the Arthritis Foundation’s New Investigator Grant. The funding source had no role in this study.

Results

The PubMed search resulted in the identification of 1027 potentially relevant publications, with an additional thirty-eight obtained through the inspection of reference lists of pertinent review articles and accepted studies along with a review of articles written by prominent authors in the field. The Embase search provided an additional 1441 unique publications. A total of twenty articles met the inclusion criteria, with publication dates ranging from 1989 to 2010. A flowchart of the systematic review process, including reasons for exclusion, is provided in Figure 1. Articles with titles and abstracts clearly not relevant to the research question were excluded without further review; in addition, many articles were excluded after a review of the abstract indicated that no patients had received total shoulder arthroplasty. Foreign-language-only studies were excluded, as translation services were not available.

Fig. 1

Summary of systematic review process. *Not relevant to the study because of unrelated topics or no patients had undergone total shoulder arthroplasty (TSA).

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Within the twenty accepted studies, nineteen different measurement tools were used to report total shoulder arthroplasty-related outcomes. Only five of these outcome measures were used in three or more studies; these included the Constant score¹³, American Shoulder and Elbow Surgeons (ASES) shoulder score¹⁴, Simple Shoulder Test (SST)¹⁵, Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)¹⁶, and visual analog scale (VAS) for pain. These outcome measures all had been used for more than 200 shoulders in at least three studies, making meta-analysis appropriate to establish trends in reporting and agreement across studies. The Constant score and ASES shoulder score use a combination of pain, shoulder motion, strength, and ability to complete activities of daily living to assess overall shoulder function, each with a zero to 100 range with lower scores indicating increased pain and less function^13,14. The SST measures the ability to successfully accomplish twelve functions, such as lifting a weight to shoulder height and the ability to work full-time¹⁵. Only these five outcome measures were analyzed further; two of the accepted studies did not use any of these five outcome measures and therefore were not included in the meta-analysis^17,18. A total of 1576 shoulders were evaluated in the twenty studies, with an average patient age of 66.2 years and an average follow-up duration of 3.7 ± 2.2 years following total shoulder arthroplasty. The most common indication for total shoulder arthroplasty was primary osteoarthritis (n = 1499), with rheumatoid arthritis and other types of inflammatory arthritis being the indication in the majority of the remaining cases (n = 60). A small number of shoulders (n = 15) were considered to have a diagnosis of either osteoarthritis or rheumatoid arthritis because, in the study by Angst et al.⁵, the number of patients with each diagnosis was reported but the diagnosis for each shoulder in the fifteen patients who received bilateral total shoulder arthroplasty was not reported. The final two shoulders were described in the Methods section; one had a diagnosis of fresh fracture, and the other, capsulorrhaphy arthropathy. More than 98% of the shoulders in this review carried a diagnosis of primary osteoarthritis or rheumatoid arthritis, and all shoulders had either an intact rotator cuff or a minor cuff tear that could be repaired during the surgical procedure. Characteristics of the accepted studies are detailed in the Appendix.

The accepted studies included three randomized controlled trials^19-21, two multicenter case series^22,23, and one case-control study comparing total shoulder arthroplasty with humeral surface replacement²⁴. The remaining fourteen were single-center case series. Two of the three randomized controlled trials compared total shoulder arthroplasty with hemiarthroplasty^19,21, and the third compared all-polyethylene to metal-backed glenoid prostheses²⁰. Relatively few shoulders were assessed in randomized controlled trials (n = 82); most were assessed in case series (n = 1472). In multiple studies, there was a separate treatment group that was treated with hemiarthroplasty, and these groups were excluded from the meta-analysis. These studies included only two controlled trials^19,21 in which random methods were used to determine which patients would receive total shoulder arthroplasty, and the choice to resurface the glenoid was left to the operating surgeon in all three case series in which total shoulder arthroplasty was compared with hemiarthroplasty^22,23,25.

All analyzed studies had an attrition rate of ≤20%, with the exception of a multicenter study by Norris and Iannotti²²; however, several authors did not report drop-out rates or loss to follow-up^23,25-30. Outside of the randomized controlled trials, selection bias was difficult to assess; sixteen of the twenty studies were case series, with the operating surgeon making the final decision about which patients would receive total shoulder arthroplasty (see Appendix). Reoperation rates were reported in fifteen of the twenty studies, with an average revision rate of 4.2%.

Global Health Measures

The authors of four studies reported results using the generic SF-36 measure on a total of 290 shoulders^5,6,21,31. The eight health domain scores in addition to the composite physical component summary (PCS) and mental component summary (MCS) scores were reported in one⁵ of these four studies. In two other studies^6,31, only domain scores were provided, and these were converted to PCS and MCS scores via the standard linear transformation¹⁶. This is accomplished by multiplying each of the eight domain scores by standardized coefficients, and adding them together to derive each summary score¹⁶. The authors of the fourth study reported only PCS and MCS scores²¹. Meta-analysis was performed on each of the eight domains, the results of which are given in Table I, as well as on the PCS and MCS scores. Pooled results for all SF-36 domains are provided in Table I. Significant improvements were demonstrated in physical function (mean change across studies [▵] = 6.5, SMD = 0.3, p = 0.002), physical role function (▵ = 21.2, SMD = 0.6, p <0.001), bodily pain (▵ = 29.1, SMD = 1.5, p < 0.001), and the PCS (▵ = 7.0, SMD = 0.7, p < 0.001). The MCS, along with its more associated domains, showed mixed results (▵ = −0.1, SMD = 0.2, p = 0.37), although no domains showed a significant decrease in scores. A high degree of heterogeneity was associated with bodily pain, general health perception, social functioning, emotional role functioning, and the MCS, indicating that a greater degree of variation in effect size can be attributed to heterogeneity. Forest plots for PCS and MCS are provided in Figure 2.

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TABLE I Summary of Meta-Analysis Results*

	Weighted Mean Score
Subscale	Preoperative	Postoperative	Mean Difference in Outcome Measure	SMD	95% CI	P Value	I²(%)
Short Form-36 (SF-36)
Physical function	60.6	67.1	6.5	0.3	0.1 to 0.5	0.002	5
Physical role function	40.4	61.6	21.2	0.6	0.3 to 0.8	<0.001	39
Bodily pain	35.7	64.8	29.1	1.5	1.0 to 2.0	<0.001	82
General health perception	70.1	68.8	−1.3	0.0	−0.4 to 0.4	0.90	75
Vitality	55.3	57.8	2.5	0.2	−0.1 to 0.5	0.24	56
Social functioning	79.3	84.6	5.3	0.4	−0.0 to 0.9	0.07	82
Emotional role functioning	80.2	82.6	2.5	0.0	−0.3 to 0.4	0.84	75
Mental health	74.7	76.6	1.9	0.2	−0.1 to 0.4	0.27	50
Physical component summary (PCS)	35.9	42.9	7.0	0.7	0.5 to 0.9	<0.001	4
Mental component summary (MCS)	53.2	53.1	−0.1	0.2	−0.3 to 0.7	0.37	84
Visual analog scale (VAS) pain score (cm)	7.2	1.4	−5.8	−2.5	−3.0 to −2.1	<0.001	69
Constant score	31.7	69.8	38.1	2.7	2.4 to 3.0	<0.001	66
American Shoulder and Elbow Surgeons (ASES) shoulder score	34.8	82.5	47.4	2.9	2.4 to 3.4	<0.001	83
Simple Shoulder Test (SST) (no. of functions)	3.1	9.6	6.5	2.3	1.6 to 3.0	<0.001	86

*SMD = standardized mean difference, CI = confidence interval, and I² = heterogeneity.

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TABLE I Summary of Meta-Analysis Results*

	Weighted Mean Score
Subscale	Preoperative	Postoperative	Mean Difference in Outcome Measure	SMD	95% CI	P Value	I²(%)
Short Form-36 (SF-36)
Physical function	60.6	67.1	6.5	0.3	0.1 to 0.5	0.002	5
Physical role function	40.4	61.6	21.2	0.6	0.3 to 0.8	<0.001	39
Bodily pain	35.7	64.8	29.1	1.5	1.0 to 2.0	<0.001	82
General health perception	70.1	68.8	−1.3	0.0	−0.4 to 0.4	0.90	75
Vitality	55.3	57.8	2.5	0.2	−0.1 to 0.5	0.24	56
Social functioning	79.3	84.6	5.3	0.4	−0.0 to 0.9	0.07	82
Emotional role functioning	80.2	82.6	2.5	0.0	−0.3 to 0.4	0.84	75
Mental health	74.7	76.6	1.9	0.2	−0.1 to 0.4	0.27	50
Physical component summary (PCS)	35.9	42.9	7.0	0.7	0.5 to 0.9	<0.001	4
Mental component summary (MCS)	53.2	53.1	−0.1	0.2	−0.3 to 0.7	0.37	84
Visual analog scale (VAS) pain score (cm)	7.2	1.4	−5.8	−2.5	−3.0 to −2.1	<0.001	69
Constant score	31.7	69.8	38.1	2.7	2.4 to 3.0	<0.001	66
American Shoulder and Elbow Surgeons (ASES) shoulder score	34.8	82.5	47.4	2.9	2.4 to 3.4	<0.001	83
Simple Shoulder Test (SST) (no. of functions)	3.1	9.6	6.5	2.3	1.6 to 3.0	<0.001	86

*SMD = standardized mean difference, CI = confidence interval, and I² = heterogeneity.

Fig. 2

Forest plot demonstrating the change in generic heath-related quality-of-life outcome measures following total shoulder arthroplasty. SD = standard deviation, Total = number of shoulders, IV = inverse variance, CI = confidence interval, random = random effects model, df = degrees of freedom, and I² = heterogeneity. The reference numbers are in parentheses after the authors’ names.

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The authors of five studies reported results using the pain VAS, for a total of 274 shoulders^{6,22,25,27,32}. A significant reduction in pain was noted, with a mean change of −5.8 cm on a 10-cm scale (SMD = −2.5, p < 0.001, 95% CI = −3.0 to −2.1, I² = 69%). A forest plot for pain is provided in Figure 2.

Shoulder-Specific Measures

The authors of eleven studies reported outcomes using the Constant score, for a total of 1032 shoulders^{5,6,20,21,23,24,28-30,33,34}. The examined shoulders showed dramatic gains on postoperative testing, with a mean increase of 38.1 points (SMD = 2.7, p < 0.001, 95% CI = 2.4 to 3.0, I² = 66%). The authors of six studies reported outcomes using the ASES shoulder score, for a total of 415 shoulders^{5,19,21,22,25,27}. Significant improvements in function were evident, with a mean increase of 47.4 points (SMD = 2.9, p < 0.001, 95% CI = 2.4 to 3.4, I² = 83%). In three articles, 222 shoulders were evaluated with use of the SST^6,22,26, which also demonstrated significant gains in function following total shoulder arthroplasty, with a mean increase of 6.5 functions (SMD = 2.3, p < 0.001, 95% CI = 1.6 to 3.0, I² = 86%). As expected, shoulder-specific measures demonstrated more dramatic gains than the SF-36 did. On the basis of the I² values, these three outcome measures showed a high degree of heterogeneity; however, improvements in scores were similar across studies with respect to all three shoulder-specific measures as shown in the forest plots in Figure 3.

Fig. 3

Forest plot demonstrating the change in shoulder-specific outcome measures following total shoulder arthroplasty. SD = standard deviation, Total = number of shoulders, IV = inverse variance, CI = confidence interval, random = random effects model, df = degree of freedom, and I² = heterogeneity. The reference numbers are in parentheses after the authors’ names.

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Sensitivity Analysis

Sensitivity analysis demonstrated that removal of individual studies had no significant effect on the generic or shoulder-specific outcome measures analyzed.

Discussion

In all accepted articles, total shoulder arthroplasty was demonstrated to be a highly effective intervention, leading to substantial gains in scores on shoulder-specific scales as well as significant gains in the scores of generic measures of pain and the SF-36. An improvement of 0.7 SMD units in the PCS indicates a moderate-to-large effect size⁹, signifying that total shoulder arthroplasty has a substantial positive effect on overall physical health and functioning. The effect of total shoulder arthroplasty on pain and the three shoulder-specific scales showed a benefit of >2 SMD units, and gains were of similar magnitude across studies. The mean improvement of 47.4 points in the ASES shoulder score is dramatic; the minimal clinically important difference for this measure is 6.4 points³⁵. The general agreement across studies in the degree of improvement allows accurate characterization of the benefit attributable to total shoulder arthroplasty in its present form.

The aims of this study were to identify health-related quality-of-life and shoulder-specific measures used to report outcomes of total shoulder arthroplasty and to characterize the effect of total shoulder arthroplasty on those measures. A broad range of outcome measures was found, although only five of them—the SF-36, pain VAS, Constant score, ASES shoulder score, and SST—were used in a sufficient number of accepted studies to warrant meta-analysis. In addition to frequency of use, it is important to consider the validity of each measure with regard to total shoulder arthroplasty. The SF-36 has been established as a valid tool to measure the health burden of arthritis, both osteoarthritis and rheumatoid arthritis^36,37. Because the vast majority of shoulders (∼99%) included in the meta-analysis had one of those two diagnoses, the SF-36 would seem to be an appropriate measure of preoperative and postoperative health-related quality of life in this study population³⁸. The ASES shoulder score has also been shown to be reliable, valid, and responsive, with a minimal clinically important difference of 6.4 points³⁵. The SST has been shown to have discriminant construct validity, to be reproducible, and to be responsive to changes in shoulder function following therapeutic interventions^15,26,39,40. However, a minimal clinically important difference has not been established with regard to the SST as it applies to total shoulder arthroplasty. The Constant score was the most common outcome measure, used in more than half of the accepted studies. In the largest study (601 shoulders), a multicenter case series by Edwards et al.²³, the authors reported results using the Constant score only. Despite its frequent use, issues surrounding the validity and reliability of the Constant score have been raised as a result of variability of results across modes of administration and the lack of age and sex norms⁴; in addition, patients presenting with glenohumeral instability can obtain scores of 95 or higher, a seemingly excellent score, even when symptoms are severe enough to warrant surgical intervention^3,41. Although we recognize the potential limitations of this measure, the Constant score may still be valuable as an outcome measure for patients with osteoarthritis³, the most common indication for total shoulder arthroplasty.

In the last decade, validated scales such as the SF-36 and the ASES shoulder score have been used in more total shoulder arthroplasty studies to report outcomes. Studies published prior to the introduction of these scales often used unique outcome measures, tended to have a smaller number of patients, and included patients with a larger variety of diagnoses, with only postoperative outcome data reported. Many outcome measures have been modified, inconsistently applied, or used on different patient populations than originally intended⁴. As a result, these publications frequently did not meet our inclusion criteria. Temporal patterns in the publication dates of accepted studies are also evident. Only one¹⁷ was published before 2000, and the authors reported outcomes via the Hospital for Special Surgery score. Since this measure was used in only one other study³², it was not included in the meta-analysis. Other outcome measures that were not analyzed include the University of California at Los Angeles (UCLA) shoulder score⁴²; Shoulder Function Assessment⁴³; Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire⁴⁴; Shoulder Pain and Disability Index (SPADI)⁴⁵; Neer rating system⁴⁶, McGill pain questionnaire^47,48, and Western Ontario Osteoarthritis of the Shoulder (WOOS) index⁴⁹. The WOOS index is a highly effective tool for measuring functionality and outcomes after treatments for osteoarthritis of the shoulder⁴⁹, with domains of physical symptoms, sports/recreation/work, lifestyle, and emotions; however, it was used in only one of the studies included in this review (n = 20 shoulders, SMD = 3.7)²¹.

Establishing the effect of total shoulder arthroplasty on health-related quality of life is important to justify its effectiveness to both patients and payers. One of the included studies compared SF-36 outcomes after total shoulder arthroplasty with those reported after total hip arthroplasty and coronary artery bypass grafting, both of which have been established as beneficial and cost-effective, and showed that the magnitude of improvement in the health-related quality of life was similar³¹. Total shoulder arthroplasty has also been associated with a shorter hospital stay, a reduced risk of complications, and no significant difference in mortality as compared with both total hip and total knee arthroplasty⁵⁰. Perioperative mortality following total shoulder arthroplasty is well below 1%⁵¹. As total shoulder arthroplasty is a relatively safe and effective intervention, rates of its use will likely continue to increase.

We did not examine outcomes associated with hemiarthroplasty, although this procedure is frequently performed. In the studies included in this review that contained both total shoulder arthroplasty and hemiarthroplasty treatment groups, the results were in agreement with the conclusion by Mather et al.⁵² that total shoulder arthroplasty is superior to hemiarthroplasty in terms of shoulder function, motion, and pain^{19,21-23,25,53,54}.

This systematic review allows future modifications to the total shoulder arthroplasty procedure to be evaluated by comparing health-related quality-of-life outcomes of modified procedures against the values expected for the current intervention. A potential limitation in generalizing these results to all total shoulder arthroplasty procedures is that both hospital and surgeon volume have an effect on outcome, with higher volumes associated with better results^55-57. Although these data were not available for this review, the studies included in this analysis were generally conducted in large centers with the reports authored by experienced surgeons. Thus, these results may not be generalizable to total shoulder arthroplasties performed in smaller-volume centers or by less experienced surgeons. A possible limitation was that we could have missed additional qualifying total shoulder arthroplasty studies had we accessed databases outside of MEDLINE (including Embase).

The greatest limitation of this analysis is the overall quality of the studies that were available. A considerable majority of shoulders were assessed in case series (n = 1472), with relatively few in randomized controlled trials (n = 82). Case series tend to show larger treatment effects⁵⁸ and greater heterogeneity⁵⁸ than trials, and they are susceptible to the Hawthorne effect because of a lack of blinding and lack of a comparison group. The Hawthorne effect is an increase in clinical response demonstrated by patients as a result of the attention they receive from being singled out and studied⁵⁹. We did not find any randomized trial comparing total shoulder arthroplasty with either placebo surgery or nonoperative treatment, largely because an important indication for total shoulder arthroplasty is failure of nonsurgical management⁶⁰. However, such a trial could clearly establish whether the improvement in physical health status and pain ratings is attributable to total shoulder arthroplasty, rather than part of the natural history of the disease, a regression to the mean, a placebo effect, or systematic errors in measurement.

Further standardization of measurements of total shoulder arthroplasty outcomes is also needed with respect to generalized health-related quality-of-life measures. In view of the relatively small number of studies examining the impact of total shoulder arthroplasty on global health-related quality of life, additional SF-36 data or dedicated health utility measures such as the low-burden EuroQol 5D will be needed to provide a reliable cost-effectiveness assessment of this increasingly used intervention. Recently Mather et al. conducted the first cost-effectiveness analysis of total shoulder arthroplasty, finding that total shoulder arthroplasty dominated hemiarthroplasty as a cost-effective treatment for glenohumeral osteoarthritis⁵². However, in determining preoperative total shoulder arthroplasty utility values, their analysis was limited to a single-center study using SF-36 data³¹, while their postoperative utility values relied on a study reporting only post-total shoulder arthroplasty SF-36 scores⁶¹ and the assumption that the effect of total shoulder arthroplasty is equal to that of hip and knee arthroplasty, procedures with well-documented health-related quality-of-life utilities. Of note, Mather et al. assumed the revision rate for total shoulder arthroplasty to be 0.5%, while our systematic review showed a rate above 4%, which would reduce its cost-effectiveness. The value of the present analysis is that it includes more studies reporting both preoperative and postoperative SF-36 data, establishes revision arthroplasty rates, and characterizes patient demographics across a much larger number of studies. However, more SF-36 data are needed because of the heterogeneity of the MCS results. The greater improvement observed in PCS scores was expected because symptoms leading to the need for total shoulder arthroplasty are primarily physical. However, it is possible that, with more SF-36 data, a stronger relationship between total shoulder arthroplasty and MCS scores could be established.

To our knowledge, this is the first comprehensive review characterizing the outcome measures commonly used in studies of total shoulder arthroplasty and the improvements that can be expected following this procedure. We found that, in the studies included in our review, total shoulder arthroplasty led to marked improvements in pain and shoulder-specific function scores in addition to significant, albeit more modest, improvements in overall health-related quality of life as indicated by changes in the SF-36. Total shoulder arthroplasty appears to be an effective intervention in patients with primary osteoarthritis or rheumatoid arthritis and without major rotator cuff pathology; however, future high-quality studies, such as randomized controlled trials, should be considered for further evaluation of the effect of total shoulder arthroplasty on health outcomes.

Appendix

Tables showing the PubMed and Embase search strategies as well as characteristics of the accepted studies are available with the online version of this article as a data supplement at jbjs.org.

Acknowledgements

Note: The authors acknowledge the assistance of research librarians Roxanne R. Cox, Mary Lou Klem, and Ahlam Saleh in formatting the search terms for entry and performing the search. They also thank Harlan Sayles, MS, for statistical support.

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Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of an aspect of this work. In addition, one or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

Topics

quality of life ; shoulder region ; shoulder replacement arthroplasty

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Michael J. Carter, Ted R. Mikuls, Smita Nayak, Edward V. Fehringer, Kaleb Michaud; Impact of Total Shoulder Arthroplasty on Generic and Shoulder-Specific Health-Related Quality-of-Life MeasuresA Systematic Literature Review and Meta-Analysis. The Journal of Bone & Joint Surgery. 2012 Sep;94(17):e127 1-9.

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