Abstract. Introduction. Minimum clinically important differences (MCIDs) are critical to understanding changes in patient-reported outcome measure (PROM) scores after total joint arthroplasty (TJA). The usage and adoption of MCIDs not been well-studied. This study was performed to IDENTIFY trends in PROM and MCID use after TJA over the past decade. Methods. All articles published in the calendar years of 2010 and 2020 in CORR, JBJS, and the Journal of Arthroplasty were reviewed. Articles relating to clinical outcomes in primary total hip arthroplasty (THA) or total knee arthroplasty (TKA) were included. For each article, all reported PROMs and (if present) accompanying MCIDs were recorded. The use of PROMs and MCIDs were compared between articles published in 2010 and 2020. Results. Overall, 263 articles from 2010 and 546 articles from 2020 were included. The total number of articles reporting any PROM after THA and TKA increased from 131 in 2010 to 194 in 2020, but the proportion of articles reporting PROMs decreased from 49.8% (131/263) to 35.5% (194/546). Both the total number and proportion of articles reporting MCIDs increased from 2.3% (3/131) in 2010 to 16.5% (32/194) in 2020. These trends persisted when analyzing THA and TKA articles individually. Conclusions. Both the absolute number and proportion of articles reporting MCIDs in conjunction with PROMs after TJA has increased in the past decade but remains low. We recommend that journal editors and meeting organizers encourage the inclusion of MCID information in all reports on clinical outcomes after joint replacement

Aims. Lower limb reconstruction (LLR) has a profound impact on patients, affecting multiple areas of their lives. Many patient-reported outcome measures (PROMs) are employed to assess these impacts; however, there are concerns that they do not adequately capture all outcomes important to patients, and may lack content validity in this context. This review explored whether PROMs used with adults requiring, undergoing, or after undergoing LLR exhibited content validity and adequately captured outcomes considered relevant and important to patients. Methods. A total of 37 PROMs were identified. Systematic searches were performed to retrieve content validity studies in the adult LLR population, and hand-searches used to find PROM development studies. Content validity assessments for each measure were performed following Consensus-based Standards for the selection of health measurement Instruments (COSMIN) guidelines. A mapping exercise compared all PROMs to a conceptual framework previously developed by the study team (‘the PROLLIT framework’) to explore whether each PROM covered important and relevant concepts. Results. The systematic searches found 13 studies, while hand searches found 50 PROM development studies, and copies of all 37 measures. Although several studies discussed content validity, none were found which formally assessed this measurement property in the adult LLR population. Development of many PROMs was rated as inadequate, no PROM had sufficient content validity in the study population, and none covered all areas of the PROLLIT framework. The LIMB-Q was the most promising and comprehensive measure assessed, although further validation in a wider sample of LLR patients was recommended. Conclusion. Current PROMs used in adults requiring, undergoing, or after undergoing LLR lack content validity and do not assess all important and relevant outcomes. There is an urgent need for improved outcome measurement in this population. This can be achieved through development of a new PROM, or through validation of existing measures in representative samples. Cite this article: Bone Jt Open 2024;5(12):1049–1066

Aims. The aims of this study were to assess quality of life after hip fractures, to characterize respondents to patient-reported outcome measures (PROMs), and to describe the recovery trajectory of hip fracture patients. Methods. Data on 35,206 hip fractures (2014 to 2018; 67.2% female) in the Norwegian Hip Fracture Register were linked to data from the Norwegian Patient Registry and Statistics Norway. PROMs data were collected using the EuroQol five-dimension three-level questionnaire (EQ-5D-3L) scoring instrument and living patients were invited to respond at four, 12, and 36 months post fracture. Multiple imputation procedures were performed as a model to substitute missing PROM data. Differences in response rates between categories of covariates were analyzed using chi-squared test statistics. The association between patient and socioeconomic characteristics and the reported EQ-5D-3L scores was analyzed using linear regression. Results. The median age was 83 years (interquartile range 76 to 90), and 3,561 (10%) lived in a healthcare facility. Observed mean pre-fracture EQ-5D-3L index score was 0.81 (95% confidence interval 0.803 to 0.810), which decreased to 0.66 at four months, to 0.70 at 12 months, and to 0.73 at 36 months. In the imputed datasets, the reduction from pre-fracture was similar (0.15 points) but an improvement up to 36 months was modest (0.01 to 0.03 points). Patients with higher age, male sex, severe comorbidity, cognitive impairment, lower income, lower education, and those in residential care facilities had a lower proportion of respondents, and systematically reported a lower health-related quality of life (HRQoL). The response pattern of patients influenced scores significantly, and the highest scores are found in patients reporting scores at all observation times. Conclusion. Hip fracture leads to a persistent reduction in measured HRQoL, up to 36 months. The patients’ health and socioeconomic status were associated with the proportion of patients returning PROM data for analysis, and affected the results reported. Observed EQ-5D-3L scores are affected by attrition and selection bias mechanisms and motivate the use of statistical modelling for adjustment. Cite this article: Bone Joint J 2024;106-B(4):394–400

In this study we compare survivorship and patient reported outcome measures in robotically assisted versus conventional Total Hip Arthroplasty (THA).

This paper investigates the hypothesis that implant survival and PROMS following THAs performed with robotic assistance were not different to outcomes following conventional THAs.

Data included all patients undergoing THA for osteoarthritis between 19 April 2016 and 31 December 2020. Analysis of PROMS outcomes was restricted to those who had completed PROMS data preoperatively and at 6 months postoperatively.

There were 157,647 procedures, including 3567 robotically assisted procedures, available for comparison of revision rates. 4557 procedures, including 130 robotically assisted procedures, had PROMS data available. The revision rate of primary THA performed with robotic assistance was not statistically different from THA performed by conventional methods (4 year cumulative percent revision 3.1% v 2.7%; HR = 1.05, p=0.67). The Oxford Hip Score, VAS for pain and the EQ-VAS score for overall health showed no statistically significant difference between the groups. The EQ-5D Utility Score showed an improved score (median score 1 v 0.88; OR = 1.58, p=0.007) for the robotically assisted group compared to the conventional group.

Robotic assisted THA was not associated with significant improvement in early revision or joint-specific PROMs. The findings may have been biased, in either direction, by unmeasured patient, surgeon, hospital and prosthesis factors. The findings (including the difference in health-related quality of life) may have also been influenced by lack of blinding. Future research should include methods to minimise these biases.

The effective capture of outcome measures in the healthcare setting can be traced back to Florence Nightingale’s investigation of the in-patient mortality of soldiers wounded in the Crimean war in the 1850s.

Only relatively recently has the formalised collection of outcomes data into Registries been recognised as valuable in itself.

With the advent of surgeon league tables and a move towards value based health care, individuals are being driven to collect, store and interpret data.

Following the success of the National Joint Registry, the British Association of Spine Surgeons instituted the British Spine Registry. Since its launch in 2012, over 650 users representing the whole surgical team have registered and during this time, more than 27 000 patients have been entered onto the database.

There has been significant publicity regarding the collection of outcome measures after surgery, including patient-reported scores. Over 12 000 forms have been directly entered by patients themselves, with many more entered by the surgical teams.

Questions abound: who should have access to the data produced by the Registry and how should they use it? How should the results be reported and in what forum?

Cite this article: Bone Joint J 2015;97-B:871–4.

Objectives. Patient-reported outcome measures (PROMs) are often used to evaluate the outcome of treatment in patients with distal radial fractures. Which PROM to select is often based on assessment of measurement properties, such as validity and reliability. Measurement properties are assessed in clinimetric studies, and results are often reviewed without considering the methodological quality of these studies. Our aim was to systematically review the methodological quality of clinimetric studies that evaluated measurement properties of PROMs used in patients with distal radial fractures, and to make recommendations for the selection of PROMs based on the level of evidence of each individual measurement property. Methods. A systematic literature search was performed in PubMed, EMbase, CINAHL and PsycINFO databases to identify relevant clinimetric studies. Two reviewers independently assessed the methodological quality of the studies on measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Level of evidence (strong / moderate / limited / lacking) for each measurement property per PROM was determined by combining the methodological quality and the results of the different clinimetric studies. Results. In all, 19 out of 1508 identified unique studies were included, in which 12 PROMs were rated. The Patient-rated wrist evaluation (PRWE) and the Disabilities of Arm, Shoulder and Hand questionnaire (DASH) were evaluated on most measurement properties. The evidence for the PRWE is moderate that its reliability, validity (content and hypothesis testing), and responsiveness are good. The evidence is limited that its internal consistency and cross-cultural validity are good, and its measurement error is acceptable. There is no evidence for its structural and criterion validity. The evidence for the DASH is moderate that its responsiveness is good. The evidence is limited that its reliability and the validity on hypothesis testing are good. There is no evidence for the other measurement properties. Conclusion. According to this systematic review, there is, at best, moderate evidence that the responsiveness of the PRWE and DASH are good, as are the reliability and validity of the PRWE. We recommend these PROMs in clinical studies in patients with distal radial fractures; however, more clinimetric studies of higher methodological quality are needed to adequately determine the other measurement properties. Cite this article: Dr Y. V. Kleinlugtenbelt. Are validated outcome measures used in distal radial fractures truly valid?: A critical assessment using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Bone Joint Res 2016;5:153–161. DOI: 10.1302/2046-3758.54.2000462

Aims

Refobacin Bone Cement R and Palacos R + G bone cement were introduced to replace the original cement Refobacin Palacos R in 2005. Both cements were assumed to behave in a biomechanically similar fashion to the original cement. The primary aim of this study was to compare the migration of a polished triple-tapered femoral stem fixed with either Refobacin Bone Cement R or Palacos R + G bone cement. Repeated radiostereometric analysis was used to measure migration of the femoral head centre. The secondary aims were evaluation of cement mantle, stem positioning, and patient-reported outcome measures.

Aims

The primary aim of this study was to describe long-term patient-reported outcomes after ulna shortening osteotomy for ulna impaction syndrome.

Aims

The main objective of this study was to examine whether the Oxford Shoulder Score (OSS) demonstrated floor or ceiling effects when used to measure outcomes following shoulder arthroplasty in a large national cohort. Secondary objectives were to assess its pain and function subscales, and to identify independent predictors for patients achieving a postoperative ceiling score following shoulder arthroplasty.

Aims

This study of patients with osteoarthritis (OA) of the hip aimed to: 1) characterize the contribution of the hip, spinopelvic complex, and lumbar spine when moving from the standing to the sitting position; 2) assess whether abnormal spinopelvic mobility is associated with worse symptoms; and 3) identify whether spinopelvic mobility can be predicted from static anatomical radiological parameters.

Aims. A substantial fraction of patients undergoing knee arthroplasty (KA) or hip arthroplasty (HA) do not achieve an improvement as high as the minimal clinically important difference (MCID), i.e. do not achieve a meaningful improvement. Using three patient-reported outcome measures (PROMs), our aim was: 1) to assess machine learning (ML), the simple pre-surgery PROM score, and logistic-regression (LR)-derived performance in their prediction of whether patients undergoing HA or KA achieve an improvement as high or higher than a calculated MCID; and 2) to test whether ML is able to outperform LR or pre-surgery PROM scores in predictive performance. Methods. MCIDs were derived using the change difference method in a sample of 1,843 HA and 1,546 KA patients. An artificial neural network, a gradient boosting machine, least absolute shrinkage and selection operator (LASSO) regression, ridge regression, elastic net, random forest, LR, and pre-surgery PROM scores were applied to predict MCID for the following PROMs: EuroQol five-dimension, five-level questionnaire (EQ-5D-5L), EQ visual analogue scale (EQ-VAS), Hip disability and Osteoarthritis Outcome Score-Physical Function Short-form (HOOS-PS), and Knee injury and Osteoarthritis Outcome Score-Physical Function Short-form (KOOS-PS). Results. Predictive performance of the best models per outcome ranged from 0.71 for HOOS-PS to 0.84 for EQ-VAS (HA sample). ML statistically significantly outperformed LR and pre-surgery PROM scores in two out of six cases. Conclusion. MCIDs can be predicted with reasonable performance. ML was able to outperform traditional methods, although only in a minority of cases. Cite this article: Bone Joint Res 2023;12(9):512–521

Objectives

The Manchester–Oxford Foot Questionnaire (MOXFQ) is a validated 16-item, patient-reported outcome measure for evaluating outcomes of foot or ankle surgery. The original development of the instrument identified three domains. This present study examined whether the three domains could legitimately be summed to provide a single summary index score.

A total of seven patients (six men and one woman) with a defect in the Achilles tendon and overlying soft tissue underwent reconstruction using either a composite radial forearm flap (n = 3) or an anterolateral thigh flap (n = 4). The Achilles tendons were reconstructed using chimeric palmaris longus (n = 2) or tensor fascia lata (n = 2) flaps or transfer of the flexor hallucis longus tendon (n = 3). Surgical parameters such as the rate of complications and the time between the initial repair and flap surgery were analysed. Function was measured objectively by recording the circumference of the calf, the isometric strength of the plantar flexors and the range of movement of the ankle. The Achilles tendon Total Rupture Score (ATRS) questionnaire was used as a patient-reported outcome measure. Most patients had undergone several previous operations to the Achilles tendon prior to flap surgery. The mean time to flap surgery was 14.3 months (2.1 to 40.7).

At a mean follow-up of 32.3 months (12.1 to 59.6) the circumference of the calf on the operated lower limb was reduced by a mean of 1.9 cm (sd 0.74) compared with the contralateral limb (p = 0.042). The mean strength of the plantar flexors on the operated lower limb was reduced to 88.9% of that of the contralateral limb (p = 0.043). There was no significant difference in the range of movement between the two sides (p = 0.317). The mean ATRS score was 72 points (sd 20.0). One patient who had an initial successful reconstruction developed a skin defect of the composite flap 12 months after free flap surgery and this resulted in recurrent infections, culminating in transtibial amputation 44 months after reconstruction.

These otherwise indicate that reconstruction of the Achilles tendon combined with flap cover results in a successful and functional reconstruction.

Cite this article: Bone Joint J 2015;97-B:215–20.

Objectives

Electronic forms of data collection have gained interest in recent years. In orthopaedics, little is known about patient preference regarding pen-and-paper or electronic questionnaires. We aimed to determine whether patients undergoing total hip (THR) or total knee replacement (TKR) prefer pen-and-paper or electronic questionnaires and to identify variables that predict preference for electronic questionnaires.

Aims. To map the Oxford Knee Score (OKS) and High Activity Arthroplasty Score (HAAS) items to a common scale, and to investigate the psychometric properties of this new scale for the measurement of knee health. Methods. Patient-reported outcome measure (PROM) data measuring knee health were obtained from the NHS PROMs dataset and Total or Partial Knee Arthroplasty Trial (TOPKAT). Assumptions for common scale modelling were tested. A graded response model (fitted to OKS item responses in the NHS PROMs dataset) was used as an anchor to calibrate paired HAAS items from the TOPKAT dataset. Information curves for the combined OKS-HAAS model were plotted. Bland-Altman analysis was used to compare common scale scores derived from OKS and HAAS items. A conversion table was developed to map between HAAS, OKS, and the common scale. Results. We included 3,329 response sets from 528 patients undergoing knee arthroplasty. These generally met the assumptions of unidimensionality, monotonicity, local independence, and measurement invariance. The HAAS items provided more information than OKS items at high levels of knee health. Combining both instruments resulted in higher test-level information than either instrument alone. The mean error between common scale scores derived from the OKS and HAAS was 0.29 logits. Conclusion. The common scale allowed more precise measurement of knee health than use of either the OKS or HAAS individually. These techniques for mapping PROM instruments may be useful for the standardization of outcome reporting, and pooling results across studies that use either PROM in individual-patient meta-analysis. Cite this article: Bone Joint Res 2023;12(10):624–635

Increased collection of patient-reported outcome measures (PROM) in registries enables international comparison of patient-centered outcomes after knee and hip replacement. We aimed to investigate 1) variations in PROM improvement, 2) the possible confounding factor of BMI, and 3) differences in comorbidity distributions between registries. Registries affiliated with the International Society of Arthroplasty Registries (ISAR) or OECD membership countries were invited to report aggregate EQ-5D, OKS, OHS, HOOS-PS and KOOS-PS values. Eligible patients underwent primary total, unilateral knee or hip replacement for osteoarthritis within three years and had completed PROMs preoperatively and either 6 or 12 months postoperatively, excluding patients with subsequent revisions. For each PROM cohort, Chi-square tests were performed for BMI distributions across registries and 12 predefined PROM strata (male/female, age 20-64/65-74/>75, high or low preoperative PROM scores). Comorbidity distributions were reported for available comorbidity indexes. Thirteen registries from 9 countries contributed data, n~130000 knee (range 140 to 79848) and n~113000 hip (range 137 to 85281). Mean EQ-5D index values (10 registries) ranged from 0.53 to 0.71 (knee) and 0.50 to 0.70 (hips) preoperatively and 0.78 to 0.85 (knee) and 0.83 to 0.87 (hip) postoperatively. Mean OKS (6 registries) ranged from 19.3 to 23.6 preoperatively and 36.2 to 41.2 postoperatively. Mean OHS (7 registries) ranged from 18.0 to 23.2 preoperatively and 39.8 to 44.2 postoperatively. Four registries reported KOOS-PS and three reported HOOS-PS. Proportions of patients with BMI >30 ranged from 35 to 62% (10 knee registries) and 16 to 43% (11 hip registries). For both knee and hip registries, distributions of patients across six BMI categories differed significantly among registries (p30 were for patients in the youngest age groups (20 to 64 and 65 to 74 years) with the lowest baseline scores. Additionally, females with lowest preoperative PROM scores had highest BMI. These findings were echoed for the OHS and OKS cohorts. Proportions of patients with ASA scores ≥3 ranged from 7 to 42% (9 knee registries) and 6 to 35% (8 hip registries). PROM-score improvement varies between international registries, which may be partially explained by differences in age, sex and preoperative scores. BMI and comorbidity may be relevant to adjust for

Introduction. There are concerns that patient-reported outcome measures (PROMs) currently used for adults requiring, undergoing or after undergoing lower limb reconstruction (LLR) are not adequately capturing the range of experiences important to these patients. The ‘Patient-Reported Outcome Measure for Lower Limb Reconstruction’ (PROLLIT) study developed a conceptual framework of outcomes identified as important and relevant by adult LLR patients. This review explored whether existing PROMs address these outcomes, and exhibit content validity in this population. Materials & Methods. A range of key PROMs was selected (n=32). Systematic and hand-searches were employed to find studies assessing content validity of these PROMs in the adult LLR population, along with PROM content and development information. A systematic review of content validity of the measures was carried out following ‘COnsensus-based Standards for the selection of health Measurement Instruments’ (COSMIN) guidance, alongside conceptual mapping of the content of the PROMs against the PROLLIT conceptual framework. Results. The searches uncovered very few content validity studies assessing the PROMs when applied in adult LLR patients. The COSMIN review found that these measures lacked content validity when applied in this population. The conceptual mapping found that PROMs did not capture all concepts identified as important and relevant in the PROLLIT framework. Conclusions. Existing PROMs applied in the adult LLR population lack content validity and fail to adequately capture relevant outcomes for this patient group. There is a need for a new, dedicated PROM designed for adult LLR patients

Aims. Hip fracture patients have high morbidity and mortality. Patient-reported outcome measures (PROMs) assess the quality of care of patients with hip fracture, including those with chronic cognitive impairment (CCI). Our aim was to compare PROMs from hip fracture patients with and without CCI, using the Norwegian Hip Fracture Register (NHFR). Methods. PROM questionnaires at four months (n = 34,675) and 12 months (n = 24,510) after a hip fracture reported from 2005 to 2018 were analyzed. Pre-injury score was reported in the four-month questionnaire. The questionnaires included the EuroQol five-dimension three-level (EQ-5D-3L) questionnaire, and information about who completed the questionnaire. Results. Of the 34,675 included patients, 5,643 (16%) had CCI. Patients with CCI were older (85 years vs 81 years) (p < 0.001), and had a higher American Society of Anesthesiologists (ASA) classification compared to patients without CCI. CCI was unrelated to fracture type and treatment method. EQ-5D index scores were lower in patients with CCI after four months (0.37 vs 0.60; p < 0.001) and 12 months (0.39 vs 0.64; p < 0.001). Patients with CCI had lower scores for all dimensions of the EQ-5D-3L pre-fracture and at four and 12 months. Conclusion. Patients with CCI reported lower health-related quality of life pre-fracture, at four and 12 months after the hip fracture. PROM data from hip fracture patients with CCI are valuable in the assessment of treatment. Patients with CCI should be included in future studies. Cite this article: Bone Jt Open 2021;2(7):454–465

Unicompartmental knee arthroplasty (UKA) and high tibial osteotomy (HTO) are well-established operative interventions in the treatment of knee osteoarthritis (KOA). However, which of these interventions is more beneficial, to patients with KOA, is not known and remains a topic of much debate. Aims: (i) To determine whether UKA or HTO is more beneficial in the treatment of isolated medial compartment KOA, via an assessment of patient-reported outcome measures (PROMs). (ii) To investigate the relationship between PROMs and radiographic parameters of knee joint orientation/alignment. This longitudinal observational study assessed a total of 42 patients that had undergone UKA (n=23) or HTO (n=19) to treat isolated medial compartment KOA. The PROMs assessed, pre-operatively and 1-year post-operatively, consisted of the: self-administered comorbidity questionnaire; short form-12; oxford knee score; knee injury and osteoarthritis outcome score; and the EQ-5D-5L. The radiographic parameters of knee joint alignment/orientation assessed, pre-operatively and 8-weeks post-operatively, included the: hip-knee-ankle angle; mechanical axis deviation; and the angle of the Mikulicz line. Statistical analysis demonstrated an overall significant (p<0.001), pre-operative to post-operative, improvement in the PROM scores of both groups. There were no significant differences in the post-operative PROM scores of the UKA and HTO group. Correlation analyses revealed that pre-operatively, a more distolaterally angled Mikulicz line was associated with worse knee function (p<0.05) and overall health (p<0.05); a relationship that, until now, has not been investigated nor commented upon within the literature. UKAs and HTOs are both efficacious operations that provide a comparable degree of clinical benefit to patients with isolated medial compartment KOA. To further the scientific/medical community's understanding of the factors that impact upon health-outcomes in KOA, future research should seek to investigate the mechanism underlying the relationship, between Mikulicz line and PROMs, observed within the current study

For all the research into arthroplasty, provision of total knee arthroplasty (TKR) services based on gender in the Australian context is yet to be explored. International literature points toward a heavily gender biased provision of TKA services, skewed away from female patients. This research has aimed to assess the current experience of Australian female patients and to explore better assessment techniques that could provide more equitable services. A retrospective cohort analysis has been conducted using pre-op PROMs data, where available, from the Australian National Joint Replacement Registry (AOANJRR), between 7 August 2018 and 31 December 2021, including: EQ VAS Health; Oxford Knee Score; joint pain; and KOOS-12. Data was adjusted for age, ASA score, BMI, primary diagnosis, public vs private hospital, surgeon gender and years of practice (as estimated from years of registry data available). Of 1,001,231 procedures performed, 27,431 were able to be analysed (12,300 male and 15,131 female). Gender-based bias against female patients reached statistical significance across all PROM scores, according to the Kruskal-Wallis test of difference (p-value <0.0001). Males were more likely to undergo TKR than females, with odds ratios remaining statistically significant when adjusted for age, ASA score, BMI, primary diagnosis, and hospital type. Numbers were further analysed for surgeon years of recorded practice and surgeon gender with mixed results. This study found that women were less likely to undergo TKR despite worse scores on every pre-op PROM available, thus we demonstrate a statistically significant gender-based bias against female patients. More effort needs to be made to identify the base of this bias and find new ways to assess patients that can provide more equitable provision of healthcare