Objectives

To study the measurement properties of a joint specific patient reported outcome measure, a measure of capability and a general health-related quality of life (HRQOL) tool in a large cohort of patients with a hip fracture.

Purpose: Unbiased outcome assessment in orthopedic clinical trials has the potential to improve trial validity. The approaches used to limit bias in outcome assessment in orthopaedic trials remain unclear. The objective of this systematic review was to assess the reporting and process of outcomes assessment practices in the current orthopaedic trauma literature. Method: We searched eight high-impact-factor medical and orthopaedic journals manually and using the MED-LINE electronic database for reports of randomized controlled trials published from 2005 to 2008 pertaining to the surgical treatment of trauma-related injuries. Two reviewers independently determined study eligibility and extracted relevant data from included trials. Results: Of the 7910 citations identified during our search, 47 randomized controlled trials, which included a total of 4706 patients, met our inclusion criteria. Of 47 studies, 39 (83%) provided a statement to describe some process of outcome assessment and 29 (74%) reported using an unblinded individual as the outcome adjudicator. Four studies (10%) reported using a second assessor to verify outcome measurements, and three studies (8%) reported the use of an adjudication committee to reach endpoint decisions via consensus. No included study provided a rationale for the use of their chosen approach to adjudication. The most commonly adjudicated outcomes included fracture healing (15 studies), reoperation rate (6 studies), and general clinical assessment of post-operative complications and limb function (30 studies), mainly by orthopaedic surgeons. Blinding of outcome assessors was not performed or unclear in 38 studies (81%). Conclusion: Despite the importance of the outcome assessment process in orthopedic trauma trials, key aspects of outcome assessment are insufficiently reported. This limits the ability of readers to assess the validity of published trials

Purpose: The purpose of this study was to evaluate how outcome assessment committees of various sizes, and the biases and personalities of its members, potentially impact a trial’s results. Method: We conducted a retrospective analysis of the available individual and consensus data from an adjudication committee in a multinational trial (the SPRINT trial) of fracture fixation alternatives. The trial committee members included six members (5 surgeons, 1 methodologist) who independently determined the outcome of reoperation, and any discordant cases were discussed in the committee until a consensus was achieved. We described the pattern of agreement among adjudicators, modeled the adjudication process, and predicted the results if a smaller committee had been used. We also tested for adjudicator biases based upon their preferences for reamed or unreamed intramedullary nails, the presence of a potentially dominant adjudicator, and evaluated the resource implications of reducing the size of an adjudication committee. Results: Overall, committee member agreement was moderate (Kappa Free=0.6). We found that reducing the number of adjudicators from six to three would have changed the consensus outcome in less than 15% of cases. Regardless of committee size, per-patient analyses also demonstrated very little change in the final study results across all fracture types or in the open fracture subgroup. Results from the original SPRINT adjudication indicated a significant decrease in the rate of reoperations associated with reamed intramedullary nailing among patients with closed fractures (relative risk 0.65; 95% confidence interval 0.46 to 0.93; p=0.02). Under the model, in committee sizes of three or less persons, these estimates of treatment effect were no longer significant. There was a significant difference between adjudicators with respect to the number of times their independent decision was in the minority but nevertheless became the final consensus decision (p=0.046), suggesting a dominant adjudicator was present in the committee. There were large predicted savings in cost and time with a reduced committee size. Conclusion: In this study, smaller committees (i.e., four or five rather than six adjudicators) would likely have produced similar results, substantially reducing costs of research

The relevance of physical activity (PA) for general health and the value of assessing PA in the free-living environment especially for assessing orthopaedic conditions and outcome are discussed. Available methods for assessing PA such as self-reports, trackers, phone apps and clinical grade monitors are introduced. An overview of devices such as accelerometers for research quality assessments is given and aspects for choosing them such as wear location, usability or study population are reviewed. Basic principles to derive mobility parameters from the PA related sensor signals are presented. The symposium explains mobility parameters, their types, definitions, validity, analysis and those with particular relevance to assess orthopaedic conditions. The application of activity monitors is orthopaedic patient studies is demonstrated in various examples such as knee and hop osteoarthritis and total joint arthroplasty, in frail elderly subjects at fall risk or patients with shoulder pathologies.

Background Critical reflection in clinical routine and research raises the question of how we measure outcome. The classical etiopathogenetic way of thinking has led to biophysical, investigator-based, ‘objective’ parameters. However, new concepts of holistic health assessment based on the WHO’s International Classification of Functioning, Disability, and Health (ICF) emphasize the patient’s (subjective) perception.

Methods We present different approaches to health and health-related quality of life assessment by applying assessment tools to specific examples and providing an overview of some of the existing instruments with an analysis of their properties.

Results Self-assessments reflect the patient’s needs more closely than biophysical parameters. Reliability and validity of the self-assessments are high and population surveys provide valid norms for comparisons. Generic instruments offer a comprehensive range of measurements, and condition-specific self-assessment tools differ in their pattern of health dimensions and their sensitivity to change (responsiveness) as expressed by specific scales. A specific set of instruments has to be compiled appropriate to the focus of interest.

Conclusions Self-assessments are an important complement to clinical signs as indicators of the patient’s condition and fulfill the requirements of the modern salutogenetic, holistic view of the patient as set out in the ICF concept. As a valid representation of the patient’s needs they help in the optimization of disease management and medical-economic planning.

This study is a prospective analysis of clinical outcome in 201 consecutive patients treated with medial patellofemoral ligament reconstruction using an autologous semitendinosus graft between October 2005 and January 2011. Patients received pre and post-operative clinical evaluation, radiological assessment and outcome scoring systems. 193 patients (92 male, 119 female) underwent 211 procedures, with mean age 26 (16–49) and follow-up 16 months (6–42 months). Indications were atraumatic recurrent patella dislocation (68%), traumatic recurrent dislocation (22.8%), instability (5%), single dislocation (2.7%) and anterior knee pain (1.4%). Trochlea dysplasia was moderate in 57% and mild in 35%. There have been no recurrent dislocations/ subluxations. 10 patients have required further surgery. The mean pre-op Kujala Scores were 55 (SE 5.21) and post-op scores improved to mean 82 (31–100) (SE 1.18)(p < 0.001). This improvement and significance is mirrored with Oxford (27 to 41), WOMAC (76 to 93), Fulkerson (53 to 83), IKDC (46 to 75), Tegner (4.1 to 5.3) and SF12 (38 to 51) scores (p < 0.005). 93% of patients were satisfied with their operation. History of prior realignment surgery was associated with significantly worse outcomes compared to patients where MPFL reconstruction was their first realignment procedure (p < 0.05). This series is the largest reported in the literature for any technique of MPFL surgery. This technique allows for objective intra-operative evaluation of the required graft tension to optimise patella tracking

Introduction

There has been a paradigm shift in orthopaedic research, it is now recognized that the extent to which interventions really make a difference to a patient's overall life is indicated by measuring one's general health status. The primary aim of this study was to report how the methodology of current evidence in hip fracture research can improve if studies included patients with cognitive impairment.

Summary

Physical activity monitoring using a single accelerometer works reliably in clinical practice and is of added value as clinical outcome tool, as it provides objective and more precise information about a patient's activity compared to currently used questionnaires.

Introduction The purpose of this study was to identify issues of importance to Juvenile Idiopathic Arthritis (JIA) patients before and after total hip arthroplasty (THA) and to determine if these issues are included in widely utilized, standardized outcome measures for THA (Western-Ontario and McMaster Universities Arthritis Index – WOMAC; Patient Specific Index – PASI).

Methods JIA patients who underwent THA between 1986 and 1999 in our institution participated in the study (n=31). An independent observer was asked to gather data forms including patient demographics, a postoperative WOMAC questionnaire, postoperative patient-generated items from the PASI, a retrospectively completed preoperative PASI form, and changes in items from pre-operative to postoperative PASI. Descriptive analysis was completed on demographic information and clinical outcomes as well as for the WOMAC and PASI scores. Spearmans rank correlation coefficients were calculated to describe the association between WOMAC and PASI scores

Results Issues deemed important by JIA patients included four symptom areas (pain, joint motion, strength, discomfort) and five activity areas (light household, leisure, clothing, sports, sex); some indicated they had no symptoms or difficulties. Issues relevant to patients shifted from predominantly symptoms before surgery, to recreational and social activities at follow-up. Comparison of postoperative WOMAC questionnaires with preoperative and postoperative PASI questionnaires revealed fundamental differences between items found in the standardized WOMAC and items deemed important by the patient. The WOMAC included less than 10% of the unweighted content deemed important by these patients at follow-up.The shift in the PASI towards more physically demanding activities after surgery indicates that patients improved, which is not reflected in the WOMAC. Correlations between postoperative WOMAC and PASI scores for pain sub-scales were low to moderate (Spearman‘s coefficient rs=0.53) and 63% of JRA patients had higher PASI than WOMAC normalized scores.

Conclusion The self-generated, self-reported portion of the PASI questionnaire provided a different perspective on the impact of THA in JIA patients. The WOMAC did not include content deemed to be important by JRA patients and did not correlate well with the patient specific instrument.

Background

Shoulder pain limits range of motion (ROM) and reduces performing activities of daily living (ADL). Objective assessment of shoulder function could be of interest for diagnosing shoulder pathology or functional assessment of the shoulder after therapy.

The feasibility of 2 wearable inertial sensors for functional assessment to differentiate between healthy subjects and patients with unilateral shoulder pathology is investigated using parameters as asymmetry.

Objective: The objective of this study was to clarify the clinical outcome of upper-extremity surgeries for the rheumatoid patients using the Japanese version of the DASH Disabilities of the Arm, Shoulder and Hand questionnaire and to investigate whether the outcome was affected by the activity of the disease.

Materials and methods: One hundred and twenty seven surgical procedures in 103 rheumatoid patients (male: 26, female: 77) were included in this study. Surgeries were performed in 4 shoulders (HHR: 4), 35 elbows (TEA: 28, synovectomy: 6 etc.), 60 wrists (Kapandji: 6, radiolunate arthrodesis: 28, total arthrodesis: 7, extensor tendon reconstruction: 19 etc), and 28 hands (MP Swanson: 13, PIP fusion: 7, thumb IP fusion: 4 etc.). The patients’ average age at the surgery was 61 years and an average duration of the disease was 11 years. The DASH (function/symptoms) score and DAS (Disease Activity Score) 28-CRP(4) were taken just before the surgery and an average of 1 year and 3 months after the surgery. According to the EULAR’s improvement criteria, disease activity and response to the medical treatment was determined.

Results: The preoperative DASH score decreased in 96 surgical procedures (76%) postoperatively and the average score decreased from 50 to 38 (n=127, p< 0.01). Change in the score was −17 in shoulder surgeries (n=4, p=0.17), −12 in elbow surgeries (n=35, p< 0.01), −12 in wrist surgeries (n=60, p< 0.01) and −10 in hand surgeries (n=28, p< 0.05). The DASH score in the patients with preoperative HDA (high disease activity: n=16, from 70 to 57, p< 0.01) remained high compared to those with preoperative LDA (low disease activity: n=23, from 45 to 32, p< 0.01) and MDA (moderate disease activity: n=88, from 47 to 36, p< 0.01). Decrease in the score was more prominent in the patients with good response to the medical treatment (n=34, −22, p< 0.01) than those with moderate response (n=38, −11, p< 0.01) or no response (n=55, −6, p< 0.05). There was no significant decrease in the postoperative score in the patients with increased DAS28-CRP (4) (n=26, −1, p=0.822).

Conclusions: The clinical outcome of upper-extremity surgeries for the rheumatoid patients was good. Control of the disease activity by the medical treatment proved to be one of the important factors to produce a favourable outcome of surgical treatment.

Introduction: The treatment of stage 3 hallux rigidus is controversial. Cheilectomy, fusion and total joint replacement have all been advocated. No consensus is agreed on the best optimal management. We present our results of a ceramic on ceramic MOJE metatarsophalangeal (MTP) joint replacement.

Aim: To find out the medium to long term outcome following MOJE MTP joint replacement.

Material and Methods: A sample of 95 patients was identified, between January 1999 to July 2006 from our data base who underwent MOJE metatarsophalangeal joint replacement. We divided these patients into three groups. First group had screw fit ceramic MOJE joint replacement; second group Mark 1 ceramic on ceramic press fit MOJE joint replacement and third group Mark 2. Indications of the surgery were osteoarthritis (primary or secondary), osteochondral defects, inflammatory arthropahty, previous infections and previously failed surgery. The outcome was analysed clinically, radiologically and functionally (using AOFAS and QALY scoring system).

Results: This study shows that the early results are promising but the medium and long term results show early radiological loosing. The significance of this is not known but based on these results we would advice caution on the use of these implants and further long term studies are required.

We validated the North American Spine Society (NASS) outcome-assessment instrument for the lumbar spine in a computerised touch-screen format and assessed patients’ acceptance, taking into account previous computer experience, age and gender.

Fifty consecutive patients with symptomatic and radiologically-proven degenerative disease of the lumbar spine completed both the hard copy (paper) and the computerised versions of the NASS questionnaire. Statistical analysis showed high agreement between the paper and the touch-screen computer format for both subscales (intraclass correlation coefficient 0.94, 95% confidence interval (0.90 to 0.97)) independent of computer experience, age and gender. In total, 55% of patients stated that the computer format was easier to use and 66% preferred it to the paper version (p < 0.0001 among subjects expressing a preference). Our data indicate that the touch-screen format is comparable to the paper form. It may improve follow-up in clinical practice and research by meeting patients’ preferences and minimising administrative work.

Introduction and Aims: In this study, we identify issues of importance to adult Juvenile Rheumatoid Arthritis (JRA) patients before and after total hip arthroplasty (THA) and determine if these issues are included in widely utilised, standardised outcome measures for THA (Western-Ontario and McMaster Universities Arthritis Index – WOMAC; Patient Specific Index – PASI).

Method: Adult JRA patients who underwent THA between 1986 and 1999 at our institution participated in the study (n=31). An independent observer gathered data, including patient demographics, a post-operative WOMAC questionnaire, post-operative patient-generated items from the PASI, a retrospectively completed pre-operative PASI form, and changes in items from pre-operative to post-operative PASI. Descriptive analysis was completed on demographic information and clinical outcomes, as well as for the WOMAC and PASI scores. Spearman’s rank correlation coefficients were calculated to describe the association between WOMAC and PASI scores.

Results: Issues deemed important by JRA patients included four symptom areas (pain, joint motion, strength, discomfort) and five activity areas (light household, leisure, clothing, sports, sex); some patients indicated they had no symptoms or difficulties. Before surgery, issues identified as relevant by patients were predominantly symptoms, whereas at follow-up, patients primarily identified recreational and social activities as the issues relevant to them.

Comparison of post-operative WOMAC questionnaires with pre-operative and post-operative PASI questionnaires revealed fundamental differences between items found in the standardised WOMAC and items deemed important by the patient. The WOMAC included less than 10% of the unweighted content deemed important by these patients at follow-up. The shift in the PASI towards more physically demanding activities after surgery indicates that patients improved, which is not reflected in the WOMAC. Correlations between post-operative WOMAC and PASI scores for pain subscales were low to moderate (Spearman rank correlation coefficient: rs = 0.53) and 63% of JRA patients had higher PASI than WOMAC normalised scores.

Conclusion: The self-generated, self-reported portion of the PASI provided a different perspective on the impact of THA in adult JRA patients and more information on issues important to these patients. The WOMAC did not include content deemed to be important by JRA patients and did not correlate well with the PASI.

To clinically diagnose and postoperatively monitor the younger or more demanding orthopaedic patients it becomes increasingly important to measure function beyond the capacity of classic scores suffering from subjectivity, pain dominance and ceiling effects. This study investigates whether a stair climbing test with accelerometer derived motion parameters in a group of healthy subjects is clinically feasible and valid to distinguish between demographic differences.

The ascending and descending of stairs (preferred speed, no handrails) was measured in 46 healthy subjects (19m/27f, no orthopaedic pathology) using a triaxial accelerometer attached with a belt to the sacrum. The study group was divided in two age groups: young group (15m/16f; age: 25 [21–38]) and old group (4m/11f; age: 67 [54–74]). Motion parameters were derived by acceleration peak detection algorithms based on step times: tup, tdown, tup-tdown,, step irregularity: irrup, irrdown and asymmetry: asymup, asymdown.

Step times were slightly higher ascending (tup=606ms) than descending (tdown=575ms, p< 0.05). The step time difference between ascending and descending (tup-tdown=31ms) showed a significant difference between the young (47ms) and elderly (−7ms). All subjects with descending times ≥20ms slower than ascending (6/46) were elderly. Irregularity and asymmetry were similar between stepping direction and age groups. Asymmetry identified the dominant leg with equal or faster steps than the non-dominant leg in 43/46 cases. Motion parameters were not correlated to gender, height or BMI.

Slower step times down than up seem a promising parameter to detect general or bilateral orthopaedic pathologies. Asymmetry identifying the dominant leg shall detect unilateral pathologies. The accelerometer assessed stair test seems suitable for routine clinical follow-up complementing classic scores.

We performed a systematic review of the literature to evaluate the use and interpretation of generic and disease-specific functional outcome instruments in the reporting of outcome after the surgical treatment of disruptions of the pelvic ring. A total of 28 papers met our inclusion criteria, with eight reporting only generic outcome instruments, 13 reporting only pelvis-specific outcome instruments, and six reporting both. The Short-Form 36 (SF-36) was by far the most commonly used generic outcome instrument, used in 12 papers, with widely variable reporting of scores. The pelvis-specific outcome instruments were used in 19 studies; the Majeed score in ten, Iowa pelvic score in six, Hannover pelvic score in two and the Orlando pelvic score in one. Four sets of authors, all testing construct validity based on correlation with the SF-36, performed psychometric testing of three pelvis-specific instruments (Majeed, IPS and Orlando scores). No testing of responsiveness, content validity, criterion validity, internal consistency or reproducibility was performed.

The existing literature in this area is inadequate to inform surgeons or patients in a meaningful way about the functional outcomes of these fractures after fixation.

Scoliosis requires three dimensional correction at a global level (curve correction) and at a local one (apical axial derotation) as well as sagittal balance management. Except for in situ contouring, previously reported surgical techniques for scoliosis correction hardly deal with all these issues. The aim of the current study was to evaluate long term clinical and radiological outcomes after in situ contouring in 85 patients with severe scoliosis (Cobb= 40 to 110°). Age influence (adults versus adolescents) and surgical approaches (anterior release and posterior correction and fusion versus posterior correction and fusion only) were also assessed. The results of the study show that the in situ contouring is comparable to other surgical techniques in terms of surgery duration and blood loss. Anterior release proved useful in severe scoliosis correction. No difference in peroperative complications was found between age groups nor between approach groups. However, adolescents recover faster than adults. No difference of revision rates in double approach versus posterior approach populations was found. No statistically significant differences were found between the adolescent and adult populations. The mean overall frontal correction reached 68%. The mean loss of correction amounted 5%. No significant evolution was found in sagittal curvatures, emphasizing the difficulties in restoring physiological curvatures in patients with severe scoliosis. Our results suggest the in situ contouring technique is fully appropriate for severe scoliosis correction, regardless of the patient’s age and approach. Besides it will not result in higher morbidity for one specific population and warrants similar outcome when properly applied.

Aims. To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures. Methods. Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed. Results. Overall, 105 trials (n = 16 to 669 participants) from 27 countries were included. Trials compared surgical interventions (n = 62), post-surgical management options (n = 17), rehabilitative interventions (n = 14), surgical versus non-surgical interventions (n = 6), and pre-surgical management strategies (n = 5). In total, 888 outcome assessments were reported across seven domains: 263 assessed body structure or function (85.7% of trials), 136 activities (68.6% of trials), 34 participation (23.8% of trials), 159 health-related quality of life (61.9% of trials), 247 processes of care (80% of trials), 21 patient experiences (15.2% of trials), and 28 economic impact (8.6% of trials). From these, 337 discrete outcomes were described. Outcome reporting was inconsistent across trials. The quality of reporting varied widely (reproducibility ranged 4.8% patient experience to 100% complications). Conclusion. Substantial heterogeneity in outcome selection, assessment methods, and reporting quality were described. Despite the large number of outcomes, few are reported across multiple trials. Most outcomes are clinically focused, with little attention to the long-term consequences important to patients. Poor reporting quality reduces confidence in data quality, inhibiting data synthesis by which to inform care decisions. Outcome reporting guidance and standardization, which captures the outcomes that matter to multiple stakeholders, are urgently required. Cite this article: Bone Jt Open 2022;3(10):832–840

Midfoot arthrodesis is the conventional surgical intervention for midfoot arthritis. Arthrodesis aims to stabilise, realign and fuse the affected joints, providing patients with improved pain and function. Current research neglects the measurement of patient reported outcomes. This study aimed to investigate objective, and patient reported outcomes of midfoot arthrodesis. The secondary aim was to identify variables predicting the development of non-union. An automated search of online patient records identified 108 eligible patients (117 feet). The rates of union, re-operations, and complications were calculated using radiographs and medical records. Logistic regression was used to model variables influencing the odds of non-union. All living patients were posted a Manchester Oxford Foot Questionnaire (MOx-FQ), a patient reported outcome assessment. Pre-operative MOx-FQ results were available in a minority of cases. Students t-test was used to compare pre- and post-operative MOx-FQ scores. The rate of union achieved was 74%. The rate of re-operations was 35%. The rate of complications was 14%. Bone grafts and staple fixation independently impacted the odds of non-union. Bone grafts decreased the odds of non-union, whilst staple fixation increased the odds. This finding agrees with the opinion of other researchers. We recommend the use of bone grafts, and the avoidance of fixation with staples. Previous attempts have been made to assess patient outcomes. However, this study is the first to use the MOx-FQ, a validated questionnaire. Therefore, this study establishes a baseline for improvements in patient reported outcomes

The aim of this study was to determine the floor and ceiling effects for both the QuickDASH and PRWE following a fracture of the distal radius. Secondary aims were to determine the degree to which patients with a floor or ceiling effect felt that their wrist was ‘normal’, and if there were patient factors associated with achieving a floor or ceiling effect. A retrospective cohort study of patients sustaining a distal radius fracture and managed at the study centre during a single year was undertaken. Outcome measures included the QuickDASH, the PRWE, EuroQol-5 Dimension-3 Levels (EQ-5D-3L), and the normal wrist score. There were 526 patients with a mean age of 65yrs (20–95) and 421 (77%) were female. Most patients were managed non-operatively (73%, n=385). The mean follow-up was 4.8yrs (4.3–5.5). A ceiling effect was observed for both the QuickDASH (22.3%) and PRWE (28.5%). When defined to be within the minimum clinical important difference of the best available score, the ceiling effect increased to 62.8% for the QuickDASH and 60% for the PRWE. Patients that achieved a ceiling score for the QuickDASH and PRWE subjectively felt their wrist was only 91% and 92% normal, respectively. On logistic regression analysis, a dominant hand injury and better health-related quality of life were the common factors associated with achieving a ceiling score for both the QuickDASH and PRWE (all p<0.05). The QuickDASH and PRWE demonstrate ceiling effects when used to assess the outcome of fractures of the distal radius. Patients achieving ceiling scores did not consider their wrist to be ‘normal’. Future patient-reported outcome assessment tools for fractures of the distal radius should aim to limit the ceiling effect, especially for individuals or groups that are more likely to achieve a ceiling score