Increasingly more emphasis is being placed on Patient Reported Outcome Measures (PROMs). There are many used and reported in clinical studies, but there are no universally accepted or preferred measures. It is important for a researcher with a non-clinical background to understand how these assessments are performed, the type of information provided by each of the measures, and which diseases states are best reported by each measure

Patient reported outcomes have become validated objective measures of success in research studies. They take time and effort to develop and administer. However, to remain relevant and universal PROMS should be gathered routinely and used to manage evidence-based change in healthcare systems. To ensure that they are adopted individual clinician involvement is key however a framework for comparison and relevance promotes engagement. Several examples will be presented of system change using PROMS and PREMS as well as using routine data to defend patient selection. How and what we present depends on whom we are expecting to influence.

Abstract

Patient-reported outcomes (PROs) are widely used in the orthopaedic field to assess the impact of conservative and surgical interventions from a patient's perspective. Available instruments cover a range of outcome parameters, such as pain, function, stiffness, quality of life or joint awareness. Choice of instrument for a specific study for clinical practice should include the appraisal of the psychometric characteristics of the measure. The presentation will focus on the assessment of the psychometric characteristics of PRO instruments and provide criteria for evaluating those. The concepts of objectivity, reliability and validity will be explained in the context of PRO instrument and the interpretation of score points derived from PRO instruments will be discussed detailing concepts such as minimal important change/difference, norm data, and thresholds based on external criteria. Finally, international guidelines that define standards for the various procedures on development, validation and translation of PRO instruments will be summarised.

Background

This article reviews four commonly used approaches to assess patient responsiveness to a treatment or therapy [Return To Normal (RTN), Minimal Important Difference (MID), Minimal Clinically Important Difference (MCID), OMERACT-OARSI (OO)], and demonstrates how each of the methods can be formulated in a multi-level modelling (MLM) framework.

Introduction

We used patient reported outcome measures (PROMS) to evaluate qualitative and societal outcomes of trauma.

Introduction

ECG contamination of paraspinal EMG measurements is a known issue ^(1,2), with several proposed methods of correction^(3,4). In addition to this some question remains to how much of an effect this contamination actually has on the EMG recordings.

The Caledonian Technique ^TM has been widely accepted as a safe and effective way of improving post-operative recovery and reducing length of stay following total knee arthroplasty. In keeping with the principles of the enhanced recovery programme its use has slowly spread from specialised units into district general hospitals. There is little evidence using PROMs that supports the use of the Caledonian Technique in the DGH setting. The primary aim of this study was to find out whether the Caledonian Technique was being successfully implemented in this district general setting for TKA. The secondary aim was to identify whether there was a difference in the patients’ perspectives of success post discharge.

This is a prospective questionnaire-based cohort study of patients undergoing total elective TKA in this DGH. It was carried out at Forth Valley Royal Hospital, Larbert, Scotland between June 2011 and 2012. All patients undergoing elective TKA were asked to complete a questionnaire assessing pain, mobilisation, function and satisfaction at 6 weeks post-operatively. Case notes of all returned questionnaires were reviewed and surgeon, protocol followed (Caledonian or non-Caledonian), length of stay, analgesic requirements, discharge analgesia and complications recorded.

We have shown that length of stay, analgesic requirement and cost were all less in the Caledonian group (n=17) compared to non-Caledonian (n=17). In addition there were statistically significant increases in patients mobilising on day 1 and achieving opiate free discharge in the Caledonian group. Patient satisfaction was higher in 11 out of 12 PROMs post discharge.

This confirms that previously shown improvements in length of stay and early mobilisation seen in specialised units can also be achieved in the DGH setting. Secondly it also shows that there is no negative impact on patient satisfaction and outcomes following early mobilisation and discharge.

In recent years, there has been an increase in using self- admistrated questionnaires to accurately assess intervention outcomes in hand surgery to determine the quality of healthcare. This study aims to evaluate whether the Manchester Modified Disabilities of the Arm, Shoulder and Hand (M2DASH) questionnaire is a valid, reliable, responsive, and unbiased outcome measure for Carpal Tunnel syndrome compared to the Disability of Arm, Shoulder, and Hand (DASH) questionnaire, Boston questionnaire (BQ), and Nerve Conduction Studies (NCS).

Introduction. Orthopedics is experiencing a significant transformation with the introduction of technologies such as robotics and apps. These, integrated into the post-operative rehabilitation process, promise to improve clinical outcomes, patient satisfaction, and the overall efficiency of the healthcare system. This study examines the impact of an app called Mymobility and intra-operative data collected via the ROSA® robotic system on the functional recovery of patients undergoing robot-assisted knee arthroplasty. Method. The study was conducted at a single center from 2020 to 2023. Data from 436 patients were included, divided into “active” patients (active users of Mymobility) and “non-active” patients. Clinical analyses and satisfaction surveys were carried out on active patients. The intra-operative parameters recorded by ROSA® were correlated with the Patient-Reported Outcome Measures (PROMs) collected via Mymobility. Result. Intra-operative data showed significant correlations with PROMs for the 48 active patients, highlighting the importance of parameters such as medial joint space and ligament laxity. No significant differences were observed between the sexes, but a positive correlation was detected between age and PROMs. The data analysis indicated that an increased medial joint space and reduced ligament laxity are associated with better PROMs. The adoption of Mymobility remained limited, with only 10% of patients fully utilizing the app. Critical factors have been identified to improve recruitment, engagement, and overall experience with the platform. Conclusion. The integration of technologies such as Mymobility and ROSA® in post-operative rehabilitation offers numerous advantages, including the objectification of data, active patient involvement, and personalized care. Challenges remain related to costs, patient compliance, and demographic limitations. Nevertheless, these technologies represent a milestone in modern peri-operative management, being able to improve clinical outcomes and the quality of care

Abstract. Background. Recurrent patellar dislocation in combination with cartilage injures are difficult injuries to treat with confounding pathways of treatment. The aim of this study is to compare the clinical and functional outcomes of patients operated for patellofemoral instability with and without cartilage defects. Methods. 82 patients (mean age-28.8 years) with recurrent patellar dislocations, who underwent soft-tissue or bony procedures, were divided into 2 matched groups (age, sex, follow-up and type of procedure) of 41 each based on the presence or absence of cartilage defects in patella. Chondroplasty, microfracture, osteochondral fixation or AMIC-type procedures were done depending on the nature of cartilage injury. Lysholm, Kujala, Tegner and Subjective Knee scores of both groups were compared and analysed. Complications and return to theatre were noted. Results. With a mean follow-up of 8 years (2 years-12.3 years), there was a significant improvement observed in all the mean post-operative Patient Reported Outcome Measures (p<0.05) of both the groups, as compared to the pre-operative scores. Comparing the 2 groups, post-operative Lysholm, Kujala and Subjective knee scores were significantly higher in patients operated without cartilage defects (p<0.05). 3 patients operated for PFJ instability with cartilage defects had to undergo patellofemoral replacement in the long term. Odds ratio for developing complications is 2.6 for patients operated with cartilage defects. Conclusion. Although there is a significant improvement in the long term outcome scores of patients operated for recurrent patellar dislocation with cartilage defects, the results are significantly inferior as compared to those without cartilage defects, along with a higher risk of developing complications and returning to theatre. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project

Patients undergoing hip resurfacing arthroplasty (HRA) is typically reserved for highly active patients. Patient Reported Outcome Measures (PROMs) such as the Oxford Hip Score (OHS) are reported to have ceiling effects, which may limit physicians' ability to measure health gain in these patients. The Metabolic Equivalent of Task (MET) index is a validated compendium assigning energy expenditure to a wide range of activities; for example, a slow walk expends 2.9 kcal/kg/hour, golf expends 4.0 kcal/kg/hour, while moderate lacrosse typically expends 8.1 kcal/kg/hour. We hypothesized that for patients with high OHS (47–48) after HRA, the MET index could better discriminate between high-performing individuals. We evaluated 97 consecutive HRA patients performed by a single surgeon. They prospectively completed an online Oxford Hip Score. They also listed three activities which they had performed independently in the preceding 2 weeks with a Likert-scale slider denoting intensity of effort. Matched data-sets were obtained from 51 patients, from which 23 had OHS of 47–48 at 6-months. Their activity with the highest MET index was selected for analysis. The 23 patients' OHS improved from 29.3 ± 7.0 preoperatively to 47.6 ± 0.5 after 6-months, while their MET indices improved from 8.5 ± 3.7 to 12.9 ± 3.5 kcal/kg/hr. The activities performed by these high-performance individuals ranged from the lowest, pilates (8.05 kcal/kg/hour), to highest, running at 22km/hr (23 kcal/kg/hour). 45% of patients undergoing HRA in this cohort had OHS of 47 and 48 at 6-months after surgery. Unlike the OHS, the MET index described variation in physical activity in these high-performance individuals, and did so on an objective measurable scale

Background. Recurrent patellar dislocation in combination with cartilage injures are difficult injuries to treat with confounding pathways of treatment. The aim of this study is to compare the clinical and functional outcomes of patients operated for patellofemoral instability with and without cartilage defects. Methods. 82 patients (mean age-28.8 years) with recurrent patellar dislocations, who underwent soft-tissue or bony procedures, were divided into 2 matched groups (age, sex, follow-up and type of procedure) of 41 each based on the presence or absence of cartilage defects in patella. Chondroplasty, microfracture, osteochondral fixation or Autologous Matrix-Induced Chondrogenesis(AMIC)-type procedures were done depending on the nature of cartilage injury. Lysholm, Kujala, Tegner and Subjective Knee scores of both groups were compared and analysed. Complications and return to theatre were noted. Results. With a mean follow-up of 8 years (2 years-12.3 years), there was a significant improvement observed in all the mean post-operative Patient Reported Outcome Measures (p<0.05) of both the groups, as compared to the pre-operative scores. Comparing the 2 groups, post-operative Lysholm, Kujala and Subjective knee scores were significantly higher in patients operated without cartilage defects (p<0.05). 3 patients operated for patellofemoral instability with cartilage defects had to undergo patellofemoral replacement in the long term. Odds ratio for developing complications is 2.6 for patients operated with cartilage defects. Conclusion. Although there is a significant improvement in the long term outcome scores of patients operated for recurrent patellar dislocation with cartilage defects, the results are significantly inferior as compared to those without cartilage defects, along with a higher risk of developing complications and returning to theatre

Background. Prosthetic implants used in primary total hip replacements have a range of bearing surface combinations (metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic, metal-on-metal); head sizes (small <36mm, large 36mm+); and fixation techniques (cemented, uncemented, hybrid, reverse hybrid), which influence prosthesis survival, patient quality of life, and healthcare costs. This study compared the lifetime cost-effectiveness of implants to determine the optimal choice for patients of different age and gender profiles. Methods. In an economic decision Markov model, the probability that patients required one or more revision surgeries was estimated from analyses of UK and Swedish hip joint registries, for males and females aged <55, 55–64, 65–74, 75–84, and 85+ years. Implant and healthcare costs were estimated from hospital procurement prices, national tariffs, and the literature. Quality-adjusted life years were calculated using utility estimates, taken from Patient-Reported Outcome Measures data for hip procedures in the UK. Results. Optimal choices varied between traditionally used cemented metal-on-polyethylene and cemented ceramic-on-polyethylene implants. Small head cemented ceramic-on-polyethylene implants were optimal for males and females aged under 65. The optimal choice for adults aged 65 and older was small head cemented metal-on-polyethylene implants. Conclusions. The older the patient, the higher the probability that small head cemented metal-on-polyethylene implants are optimal. Small head cemented ceramic-on-polyethelyne implants are optimal for adults aged under 65. Our findings can influence NICE guidance, clinical practice, and commissioning of services. Funding. NIHR Research for Patient Benefit programme PB-PG-0613-31032

Background and aims. Hallux rigidus in the metatarsophalangeal joint (MTPJ) can be treated with arthroplasty to reduce pain and enhance motion. Few studies have investigated the functionality and the survival of HemiCap arthroplasty. Primarily we aimed to examine the medium to long-term functionality and the degree of pain after surgery. Secondarily the failure and revision rate of HemiCap implants. Methods. A total of 106 patients were operated with HemiCap arthroplasty (n=114) from 2006 to 2014, median age 53 (16 to 80) years, 78 females, 37 dorsal flange (DF) implants. Patient charts were reviewed retrospectively to collect revision data. Pre operative Coughlin/Shurnas arthrosis degree, hallux valgus (HV), intermetatarsalintermetatarsal (IM) and Distal Metaphyseal Articular Angle (DMAA) angles was were measured. Pre- and post operative 3 weeks, 6 months, 1 and 2 year2-year pain levels of the first MTPJ by Visuel Analog Skala (VAS 1–10), American Orthopaedic Foot and Ankle Score (AOFAS 0 to 100 points) and, Range of Motion (ROM), were available for 51 patients. FortysevenForty-seven of the 70 available for reexamination partook in a cross sectional follow up where the Self-Reported Foot and Ankle Score (SEFAS 0–48 points) was added to the Patients Related Outcome Measures (PROMs). Statistics. Kaplan-Meier for survival analysis, adjusted for sex, radiological angles, degree of arthrosis and dorsal flange. Prospective PROMs and ROM compared by paired t-test. Results. At 3, 5 and 7 years we had an mean implant survival of 85%, 83% and 78%. Almost all were revised due to pain, one due to malalignment and one due to loosening of the Hemicap. Dorsal flange, gender, preoperative arthrosis degree, HV, IM or DMAA angles did not statistically influence the result. For those (n=23) that were re-examined, preoperative dorsal ROM changed from mean(sd) 21 (6) to 42 (18) degrees, VAS from 7 (2) to 2 (2) and AOFAS from 61 (11) to 87 (11) (p < 0.001). At mean 5 year follow up (n=47), mean (sd) dorsal ROM was 46 (17) degrees,. AOFAS was 84 (9), VAS 2 (1) and SEFAS 42 (6) points. The dorsal flange made no statistical significant difference for ROM or PROMs, but DF displayed 51 degrees of extension vs. 44 without (p=0.1). Periprostethic lucency (<2 mm) was observed in 27/47. Conclusions. In general, we saw an acceptable implant survival rate. We did not find any predictors that influenced implant failure and the design alterations with the dorsal flange are not evident clinically. Patients who were not revised had significantly less pain, greater ROM, and better overall foot and ankle conditions than preoperatively, but the data are biased by missing numbers and revisions

Background. Multiple randomised controlled trials have demonstrated that arthroscopy provides little benefit in patients with knee osteoarthritis. In 2008, NICE released guidelines to reflect this evidence. Implementation has been sporadic, and arthroscopy for knee osteoarthritis is commonly performed with an annual incidence of 9.9 per 10,000 in England. Our aim was to establish whether previous arthroscopy affects Patient Reported Outcome Measures (PROMs) in Total Knee Replacement (TKR) patients. Methods. Data was retrospectively collected from 2010–2012 from a University hospital. Pre-operative and one-year post-operative PROMs were collected on patients who had undergone arthroscopy and then TKR, or only TKR. The change in PROMs score over TKR was then compared between groups. Results. Complete data was available for 85 patients: 36 had arthroscopy prior to TKR, with 49 receiving only TKR. There was no difference between the groups with regard to age and gender. Oxford Knee Score (OKS) before TKR for both groups were similar (arthroscopy group 41.9, non-arthroscopy 40.8). At arthroscopy 81% of patients had grade IV arthritis, with 19% demonstrating grade III. Patients who had arthroscopy before TKR had a worse response to TKR compared to those who did not have an arthroscopy (respective mean change of 23.79%, 38.4%, p< 0.001). Conclusions. Although this exploratory study is small and subject to selection bias, our data suggest that arthroscopy may have a detrimental effect on patient function after TKR. This may be due to psychological factors, as there is growing evidence to suggest stress and anxiety negatively affect PROMs4. Medicalisation of patients through arthroscopic procedures may contribute to poor PROMs. This study offers a potential pre-operative factor that may explain some of the variability in outcome seen with TKR. This relationship requires confirmation and exploration in larger studies with correction for confounding factors. Level of evidence. III

Background/Purpose of study. The increasing aging of the population will see a growing number of patients presenting for spine surgery with appropriate indications but numerous medical comorbidities. This complicates decision-making, requiring that the likely benefit of surgery (outcome) be carefully weighed up against the potential risk (complications). We assessed the influence of comorbidity on the risks and benefits of spine surgery. Methods. 3′699 patients with degenerative lumbar disorders, undergoing surgery with the goal of pain relief, completed the multidimensional Core Outcome Measures Index (COMI; scored 0–10) before and 12 months after surgery. At 12mo they also rated the global treatment outcome and their satisfaction. Using the Eurospine Spine Tango Registry, surgeons documented surgical details, American Society of Anesthesiologists (ASA) scores and surgical/general complications. Results. 29.8% patients were rated ASA1 (normal healthy), 44.8% ASA2 (mild/moderate systemic disease), 25.0% ASA3 (severe) and 0.4% ASA4 (life-threatening). In going from ASA1 to ASA3 (ASA4 group too small), surgical complications increased significantly from 3.6% to 11.1% and general complications increased from 2.3% to 12.6%; 12-month outcomes showed a corresponding decline, with a good global outcome being reported by 78% ASA1 patients, 76% ASA2, and 68% ASA3. Satisfaction with treatment was 87%, 85%, and 79%, respectively and reduction in COMI, 4.2±2.9, 3.7±3.0, and 3.3±3.0 points, respectively. Conclusion. The negative impact of comorbidity on the outcome of spine surgery has not been well investigated/quantified to date. The ASA grade may be helpful in producing algorithms for decision-making and preoperative counselling regarding the corresponding risks and benefits of surgery. No Conflict of interest. No funding obtained. This abstract has not been previously published in whole or substantial part nor has it been presented previously at a national meeting

Summary. The dGEMRIC index correlates more strongly with the pattern of radiographic joint space narrowing in hip osteoarthritis at five year follow-up than morphological measurements of the proximal femur. It therefore offers potential to refine predictive models of hip osteoarthritis progression. Introduction. Longitudinal general population studies have shown that femoroacetabular impingement increases the risk of developing hip osteoarthritis, however, morphological parameters have a low positive predictive value. Arthroscopic debridement of impingement lesions has been proposed as a potential strategy for the prevention of osteoarthritis, however, the development of such strategies requires the identification of individuals at high risk of disease progression. We investigated whether delayed Gadolinium-Enhanced MRI of Cartilage (dGEMRIC) predicts disease progression. This imaging modality is an indirect measure of cartilage glycosaminoglycan content. Patients and Methods. 34 asymptomatic individuals from a longitudinal cohort study (sibkids) were assessed at baseline with the collection of Patient Reported Outcome Measures (PROMs), anteroposterior and cross-table lateral radiographs, 3D morphological MRI, and dGEMRIC at 3T of their index hip. A dGEMRIC index was calculated as a ratio of the anterosuperior acetabular cartilage T1 relaxation time and the total femoral and acetabular cartilage T1 relaxation time. 29 individuals were followed up at 5 years for repeat assessment (average age 51 years and range 36 to 67). Radiological measurements were made by a single observer using in house Hipmorf software. Radiographic disease progression was assessed using minimum joint space width (JSW), lateral sourcil JSW, and medial sourcil JSW. These were measured on baseline and five year follow-up anteroposterior radiographs with an intra-observer ICC of 0.916. Alpha angle measurements were made by the same observer on radiographs and MRI radial slices with an intra-observer ICC of 0.926. Results. Mean minimum JSW for the cohort fell by 0.16mm over five years (p=0.024). Baseline dGEMRIC index did not correlate with change in minimum JSW (r=0.031 p=0.873). There was a moderate correlation between baseline dGEMRIC and the direction of JSW loss (change in JSW at the lateral sourcil minus change in JSW at the medial sourcil) (r=0.561 p=0.002). There was a weak correlation between the change in Non-Arthritic Hip Score and baseline dGEMRIC (r=0.256 P=0.180). Maximum alpha angle measured on baseline MRI radial slices did not correlate with change in minimum JSW and weakly correlated with the direction of JSW narrowing (r=0.273 p=0.160). Conclusion. A low dGEMRIC index indicates reduced glycosaminoglycan concentration in the anterosuperior acetabular cartilage compared with the total femoral and acetabular cartilage. This correlates with lateral JSW narrowing relative to medial JSW narrowing as osteoarthritis progresses. The dGEMRIC index correlates better with osteoarthritis progression than alpha angle measurements and offers the potential to refine a predictive model for osteoarthritis progression to aid patient selection for clinical trials

Summary. Bi-plane Image matching method is very useful technique to evaluate the loaded 3D motion of each cervical level. Introduction. Cervical orthoses are commonly used to regulate the motion of cervical spines for conservative treatment of injuries and for post-operative immobilization. Previous studies have reported the efficacy of orthoses for 2D flex-extension or 3D motions of the entire cervical spine. However, the ability of cervical orthoses to reduce motion might be different at each intervertebral level and for different types of motion (flexion-extension, rotation, lateral bending). The effectiveness of immobilizing orthoses at each cervical intervertebral level for 3D motions has not been reported. The purpose of this study is to evaluate the effectiveness of the Philadelphia collar to each level of cervical spines with 3D motion analysis under loading condition. Patients & Methods. Patient Sample: Four asymptomatic volunteer subjects were recruited and provided informed consent. Approval of the experimental design by the institutional review board was obtained. These 4 individuals were without any history of cervical diseases or procedures. The presence of any symptoms, spinal disorders and anatomical abnormalities in fluoroscopic images or CT was a criterion of exclusion from this study. Outcome Measures: To evaluate the efficacy of the Philadelphia collar, ANOVA was used to compare the range of motion with and without collar at the C3/4, C4/5, C5/6 and C6/7 intervertebral levels for each motion. The level of statistical significance was set at p<0.05. When a statistical difference was detected, post hoc Tukey tests were performed. Methods. Three-dimensional models of the C3-C7 vertebrae were developed from CT scans of each subject using commercial software. Two fluoroscopy systems were positioned to acquire orthogonal images of the cervical spine. The subject was seated within the view of the dual fluoroscopic imaging system. Pairs of images were taken in each of 7 positions: neutral posture, maximum flexion and extension, maximum left and right lateral bending, and maximum left and right rotation. The images and 3D vertebral models were imported into biplane 2D-3D registration software, where the vertebral models were projected onto the pair of digitised images and the 3D bone pose was adjusted to match its radiographic projection in each image. Relative motions between each vertebral body were calculated from body-fixed coordinate systems using a flexion-lateral bending-axial rotation Cardan angle sequence. Results. Flexion range was significantly reduced with the collar at each cervical level. Extension range was significantly reduced at the C3/4 level. Rotation and lateral bending were reduced for C3/4, C4/5, C5/6 levels with the collar. Discussion/Conclusion. The Philadelphia Collar significantly reduces cervical motion at C3/4, C4/5 and C5/6 levels in almost all motions (except for extension). At the C6/7 level, this type of collar has limited effectiveness reducing cervical motion. We used 3D radiographic measurements to quantify the effectiveness of the Philadelphia collar for reducing cervical motion. Bi-plane 2D-3D registration method is useful technique to evaluate 3D motion of cervical spines