Patient-reported Outcome Measures Data Research Articles

Digital Patient Reported Outcome Measures Platform for Post-COVID-19 Condition and Other Long-Term Conditions: User-Centered Development and Technical Description.

Post-COVID-19 condition (PCC), colloquially known as long COVID, is a multisystem condition characterized by persistent symptoms beyond 4 weeks after the SARS-CoV-2 infection. More than 60 million people with PCC worldwide need prompt assessment, diagnosis, and monitoring, with many requiring specialist help from a multidisciplinary team of health care professionals (HCPs). Consequently, a scalable digital system is required for both people with PCC and HCPs to capture the breadth of symptoms and their impact on health, using patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs). We aim to develop and implement a novel PCC digital PROM (DPROM) platform for (1) securely collecting PROM and PREM data from people with PCC, (2) enabling users to monitor symptoms longitudinally and assess response to treatment, (3) generating reports for the electronic health records (EHRs), (4) providing summary reports on PCC services based on national requirements, and (5) facilitating the sharing of relevant data with authorized research teams to accelerate our understanding of this new condition and evaluate new strategies to manage PCC. We (1) undertook requirement analysis with people with PCC, HCPs, and researchers to identify the needs of the DPROM platform and determine its required functionalities; (2) designed and developed a clinically useful web portal for staff and a mobile app for patients, with a web-based alternative app to improve patient and staff choice, limit the risk of digital exclusion, and account for variability across services; (3) determined the PROMs and PREMs that PCC services would prefer to use on the platform; and (4) designed the summary report function that can be generated for each user for the EHR and for reporting to national health authorities. A DPROM platform to record PCC symptom profile, condition severity, functional disability, and quality of life, based on the C19-YRS (Yorkshire Rehabilitation Scale) and other PROMs and PREMs, was developed. Individual-level medical information and details on the COVID-19 illness can be captured systematically. The platform generates easy-to-understand scores, radar plots and line graphs for people with PCC to self-monitor their condition and for HCPs to assess the natural course of the condition and the response to interventions. Clinics can configure a suite of PROMs and PREMs based on their local and national service and commissioning requirements and support research studies which require large-scale data collection on PROMs. The DPROM platform enables automatic aggregate data analysis for services to undertake service evaluation and cost-effectiveness analysis. The DPROM platform generated summary report can be uploaded to the EHRs of people with PCC. A multifunctional DPROM platform to assess, grade, and monitor PCC has been developed. Future research will analyze the system's usability in specialist PCC clinical services and other long-term conditions.

Overcoming floor and ceiling effects in knee arthroplasty outcome measurement.

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. 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. 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. 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.

Use of global sagittal flexibility to predict proximal junctional kyphosis after spinal deformity surgery.

Sagittal alignment is an important predictor of functional outcomes after surgery for adult spinal deformity (ASD). A rigid spinal column may create a large lever arm that may impact the rate of proximal junctional kyphosis (PJK) after ASD surgery. In this study, the authors sought to determine whether relatively low preoperative global spinal flexibility (i.e., rigid spine) predicts increased incidence of PJK at 1 year after ASD surgery. The authors retrospectively reviewed long-segment thoracolumbar fusions with pelvic fixation performed at a single tertiary care center between October 2015 and September 2020 in patients with a minimum of 1-year radiographic and clinical follow-up. Two cohorts were established on the basis of the optimal value for spinal flexibility, as defined by the absolute difference between the preoperative standing and supine C7 sagittal vertical axes, which the authors termed global sagittal flexibility (GSF). Demographic information, radiographs, various associated complications, and patient-reported outcome measures (PROMs) were analyzed. Eighty-five patients met the inclusion criteria. Receiver operating characteristic (ROC) analysis using GSF to predict an increase in the proximal junctional sagittal Cobb angle (PJCA) greater than or equal to 10° at 1-year follow-up provided an area under the curve of 0.64 and identified an optimal GSF threshold value of 3.7 cm. Patients with GSF > 3.7 cm were considered globally flexible (48 patients), and those with GSF ≤ 3.7 cm were classified as rigid (37 patients). Rigid patients were noted to have a significantly higher risk of ΔPJCA ≥ 10° at 1-year follow-up (51.4% vs 29.3%, p = 0.049). No changes in the reoperation rates or PROMs based on GSF were observed in the 1- or 2-year postoperative window. Based on these retrospective data, preoperative global spinal rigidity portends an independently elevated risk for the development of PJK after ASD surgery. No differences in other complication rates or PROMs data were observed between groups. Data collection was limited to a 2-year postoperative window; therefore, longer follow-up is required to further elucidate the relationship between rigidity and reoperation rates. Based on these retrospective data, flexibility may influence the outcomes of patients with ASD.

Does Patient-Reported Outcome Measures Use at New Foot and Ankle Patient Clinic Visits Improve Patient Activation, Experience, and Satisfaction?

Category: Other; Ankle Introduction/Purpose: Patient-reported outcome measures (PROMs) can help predict clinical outcomes and improve shared clinical decision-making discussions. There remains a paucity of research assessing how the use of PROMs may drive improved patient experience and patient activation. This randomized, controlled trial study objectives: 1) Determine if the active use and discussion of PROMs during new patient visits are associated with patient satisfaction and experience 2) Determine if the active use and discussion of PROMs during new patient clinic visits are associated with patient activation; and 3) To determine if the objectives (1) and (2) differ based on surgeon or sociodemographic factors. Methods: This Institutional Review Board (IRB) approved singled-blinded RCT was registered prior to data collection on ClinicalTrials.gov (NCT04654910). As a standard of care, new foot and ankle patients completed PROMIS Physical Function (PF), Pain Interference (PI), and Depression assessments. Patients were then randomized to viewing and discussing their PROMIS scores with their surgeon or not. Following the clinic visit, patients completed a series of Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) questions and the Patient Activation Measure (PAM). CG-CAHPS findings and PAM responses were compared between the two groups and after clustering on surgeon. Potential interaction effects by social deprivation were also explored. Results: After enrolling patients but removing those lost to follow-up or with missing data, 97 and 116 patients remained in the intervention control cohorts, respectively. No difference was found in CG-CAHPS responses, nor PAM scores between the two groups (p>0.05). All surgeons were highly rated by all patients. When clustered by surgeon, intervention subjects were less likely to indicate “top box” scores for the understanding domain of the CG-CAHPS question (OR:0.51;p < 0.001) and had decreased odds of high patient activation compared to control subjects (OR:0.67;p=0.005). Among the most socially disadvantaged patients, there was no difference in control and intervention subjects in their likelihood of having high patient activation (p=0.09). Conclusion: Well perceived foot and ankle surgeons who show and discuss PROMs results may not improve the patient experience or activation and may, in fact, decrease understanding or patient activation in select populations. Future work is needed to determine when PROMs discussions are most beneficial and how best to present PROMs data. Health literacy tools and/or communication training may better engage different patient groups regarding PROMs.

Outcome of patients with osteoarthritis aged 90 to 101 years after cemented total hip arthroplasty: 1,385 patients from the Swedish Arthroplasty Register.

Few studies have focused on nonagenarians treated with total hip arthroplasty (THA). We investigated 30- and 90-day postoperative mortality, patient-reported outcome measures (PROMs), reoperation rate, risk factors for reoperation, and relative patient survival in nonagenarians or older. 167,091 patients with primary cemented THA performed for osteoarthritis between 1992 and 2019 were identified in the Swedish Arthroplasty Register. Patients were divided into age groups based on age at time of surgery: 60-74 (n = 90,285), 75-89 (n = 75,421), and > 90 years (n = 1,385). Mortality rate, PROMs (pain-Likert scale, satisfaction-Likert scale, EQ-VAS, n = 67,553), reoperation rate, risk factors for reoperation, and relative patient survival were studied. The nonagenarians had the highest postoperative mortality rate, 1.7% and 2.6% at 30 and 90 days, respectively. Nonagenarian females reported significantly lower pre- and postoperative EQ-VAS compared with patients aged 60-89 years but reported least pain and highest patient satisfaction 1 year after surgery. At 2 years the nonagenarians had highest reoperation frequency-2.7%-due to infection (1.5%), dislocation (0.8%), and periprosthetic fracture (0.4%). Increasing age, male sex, and polished stem were associated with higher risk of reoperation within 2 years. 8-year age- and sex-matched relative survival was highest among nonagenarians (study group/matched population: ≥ 90 years 3.4, 95% confidence interval [CI] 3.0-3.8; 75-89 years: 1.4, CI 1.4-1.4, and 60-74 years: 1.1, CI 1.1-1.1). 30- and 90-day postoperative mortality and reoperation rates were higher in nonagenarians but PROM data showed least pain and highest patient satisfaction 1 year after surgery with THA among female nonagenarians with primary osteoarthritis.

Outcomes of Surgically Treated Purely Ligamentous Stage II Lisfranc Injuries.

Low-energy stage II Lisfranc injuries are rare, and treatment can be operative or nonoperative based on a surgeon's assessment of midfoot stability. No previously published patient-reported outcome measures (PROMs) data for Lisfranc injuries isolates purely ligamentous stage II injuries. The purpose of this study was to analyze PROMs for patients who underwent operative management of stage II Lisfranc injuries. Thirty-nine patients (39 feet) with confirmed Nunley-Vertullo stage II Lisfranc injuries between May 2012 and February 2022 were identified through a retrospective chart review. PROMs that were analyzed were the visual analog scale (VAS) pain scale, Veterans RAND 12-Item Health Survey (VR-12), Foot and Ankle Ability Measure (FAAM), and patient satisfaction. Thirty-two open reduction internal fixations (ORIFs) and 7 fusions were performed. The mean latest follow-up was 44.6 (range, 12-92) months. There were 2 complications (5%, 2/39) that required a revision procedure. Twenty-six patients (67%, 26/39) underwent secondary surgery to remove retained hardware. The mean time to hardware removal was 3.97 (range, 2.70-7.47) months. The overall mean patient satisfaction score with overall medical care including clinical visits and interactions with medical staff personnel was 93.6/100. All PROMs (VAS, VR-12, FAAM) demonstrated statistically significant improvement (P < .05) from preoperative (injury) values to latest follow-up postinjury values. Patients who were treated surgically with stage II purely ligamentous Lisfranc injuries via the methods used were found to mostly undergo hardware removal and have high levels of overall satisfaction with their process of medical care. Level IV, retrospective case series.

Development of an implementation strategy for routine collection of generic patient reported outcome measures: a qualitative study in multidisciplinary community rehabilitation

Purpose To explore staff perceptions of barriers and enablers towards implementing the EQ-5D-5L in community rehabilitation, and develop a theory-informed implementation approach for routine administration of generic patient-reported outcome measures (PROMs) using implementation science frameworks. Materials and methods A qualitative study was conducted at three sites. Multidisciplinary rehabilitation staff completed individual semi-structured interviews, which were transcribed and coded against the Theoretical Domains Framework (TDF). We identified and selected potentially effective behaviour change techniques using the Behavior Change Wheel. Hypothetical strategies were operationalised. Results Twenty-one interviews were conducted, and four themes emerged: (1) The Impact of PROMs on patient centered-care; (2) Considerations for validity of PROMs; (3) Service-level impact of embedding PROMs; (4) Practical issues of embedding PROMs within the service. Barriers and enablers were mapped to seven of the TDF domains; relating most to clinicians’ “belief about consequences”, “reinforcement”, and “environmental context and resources”. Five hypothetical strategies were developed to overcome identified barriers and strengthen enablers. Key behaviour change techniques underpinning the strategies include: restructuring the physical environment, incentivisation, persuasion and education, enablement, and, social support. Conclusions Our implementation approach highlights the importance of automating processes, engaging site champions, routinely reporting, and using PROM data to inform service provision.

Remote Symptom Monitoring With Ecological Momentary Computerized Adaptive Testing: Pilot Cohort Study of a Platform for Frequent, Low-Burden, and Personalized Patient-Reported Outcome Measures.

Remote patient-reported outcome measure (PROM) data capture can provide useful insights into research and clinical practice and deeper insights can be gained by administering assessments more frequently, for example, in ecological momentary assessment. However, frequent data collection can be limited by the burden of multiple, lengthy questionnaires. This burden can be reduced with computerized adaptive testing (CAT) algorithms that select only the most relevant items from a PROM for an individual respondent. In this paper, we propose "ecological momentary computerized adaptive testing" (EMCAT): the use of CAT algorithms to reduce PROM response burden and facilitate high-frequency data capture via a smartphone app. We develop and pilot a smartphone app for performing EMCAT using a popular hand surgery PROM. The aim of this study is to determine the feasibility of EMCAT as a system for remote PROM administration. We built the EMCAT web app using Concerto, an open-source CAT platform maintained by the Psychometrics Centre, University of Cambridge, and hosted it on an Amazon Web Service cloud server. The platform is compatible with any questionnaire that has been parameterized with item response theory or Rasch measurement theory. For this study, the PROM we chose was the patient evaluation measure, which is commonly used in hand surgery. CAT algorithms were built using item response theory models derived from UK Hand Registry data. In the pilot study, we enrolled 40 patients with hand trauma or thumb-base arthritis, across 2 sites, between July 13, 2022, and September 14, 2022. We monitored their symptoms with the patient evaluation measure, via EMCAT, over a 12-week period. Patients were assessed thrice weekly, once daily, or thrice daily. We additionally administered full-length PROM assessments at 0, 6, and 12 weeks, and the User Engagement Scale at 12 weeks. The use of EMCAT significantly reduced the length of the PROM (median 2 vs 11 items) and the time taken to complete it (median 8.8 seconds vs 1 minute 14 seconds). Very similar scores were obtained when EMCAT was administered concurrently with the full-length PROM, with a mean error of <0.01 on a logit (z score) scale. The median response rate in the daily assessment group was 93%. The median perceived usability score of the User Engagement Scale was 4.0 (maximum possible score 5.0). EMCAT reduces the burden of PROM assessments, enabling acceptable high-frequency, remote PROM data capture. This has potential applications in both research and clinical practice. In research, EMCAT could be used to study temporal variations in symptom severity, for example, recovery trajectories after surgery. In clinical practice, EMCAT could be used to monitor patients remotely, prompting early intervention if a patient's symptom trajectory causes clinical concern. ISRCTN 19841416; https://www.isrctn.com/ISRCTN19841416.

Outcomes in Ankle Replacement Study (OARS).

The aim of this study was to capture 12-month outcomes from a representative multicentre cohort of patients undergoing total ankle arthroplasty (TAA), describe the pattern of patient-reported outcome measures (PROMs) at 12 months, and identify predictors of these outcome measures. Patients listed for a primary TAA at 19 NHS hospitals between February 2016 and October 2017 were eligible. PROMs data were collected preoperatively and at six and 12 months including: Manchester-Oxford Foot and Ankle Questionnaire (MOXFQ (foot and ankle)) and the EuroQol five-dimension five-level questionnaire (EQ-5D-5L). Radiological pre- and postoperative data included Kellgren-Lawrence score and implant position measurement. This was supplemented by data from the National Joint Registry through record linkage to determine: American Society of Anesthesiologists (ASA) grade at index procedure; indication for surgery, index ankle previous fracture; tibial hind foot alignment; additional surgery at the time of TAA; and implant type. Multivariate regression models assessed outcomes, and the relationship between MOXFQ and EQ-5D-5L outcomes, with patient characteristics. Data from 238 patients were analyzed. There were significant improvements in MOXFQ and EQ-5D-5L among people who underwent TAA at six- and 12-month assessments compared with preoperative scores (p < 0.001). Most improvement occurred between preoperative and six months, with little further improvement at 12 months. A greater improvement in MOXFQ outcome postoperatively was associated with older age and more advanced radiological signs of ankle osteoarthritis at baseline. TAA significantly benefits patients with end-stage ankle disease. The lack of substantial further overall change between six and 12 months suggests that capturing PROMs at six months is sufficient to assess the success of the procedure. Older patients and those with advanced radiological disease had the greater gains. These outcome predictors can be used to counsel younger patients and those with earlier ankle disease on the expectations of TAA.

Height Gain Following Correction of Adult Spinal Deformity.

Height gain following a surgical procedure for patients with adult spinal deformity (ASD) is incompletely understood, and it is unknown if height gain correlates with patient-reported outcome measures (PROMs). This was a retrospective cohort study of patients undergoing ASD surgery. Patients with baseline, 6-week, and subanalysis of 1-year postoperative full-body radiographic and PROM data were examined. Correlation analysis examined relationships between vertical height differences and PROMs. Regression analysis was utilized to preoperatively estimate T1-S1 and S1-ankle height changes. This study included 198 patients (mean age, 57 years; 69% female); 147 patients (74%) gained height. Patients with height loss, compared with those who gained height, experienced greater increases in thoracolumbar kyphosis (2.81° compared with -7.37°; p < 0.001) and thoracic kyphosis (12.96° compared with 4.42°; p = 0.003). For patients with height gain, sagittal and coronal alignment improved from baseline to postoperatively: 25° to 21° for pelvic tilt (PT), 14° to 3° for pelvic incidence - lumbar lordosis (PI-LL), and 60 mm to 17 mm for sagittal vertical axis (SVA) (all p < 0.001). The full-body mean height gain was 7.6 cm, distributed as follows: sella turcica-C2, 2.9 mm; C2-T1, 2.8 mm; T1-S1 (trunk gain), 3.8 cm; and S1-ankle (lower-extremity gain), 3.3 cm (p < 0.001). T1-S1 height gain correlated with the thoracic Cobb angle correction and the maximum Cobb angle correction (p = 0.002). S1-ankle height gain correlated with the corrections in PT, PI-LL, and SVA (p < 0.001). T1-ankle height gain correlated with the corrections in PT (p < 0.001) and SVA (p = 0.03). Trunk height gain correlated with improved Scoliosis Research Society (SRS-22r) Appearance scores (r = 0.20; p = 0.02). Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scores correlated with S1-ankle height gain (r = -0.19; p = 0.03) and C2-T1 height gain (r = -0.18; p = 0.04). A 1° correction in a thoracic scoliosis Cobb angle corresponded to a 0.2-mm height gain, and a 1° correction in a thoracolumbar scoliosis Cobb angle resulted in a 0.25-mm height gain. A 1° improvement in PI-LL resulted in a 0.2-mm height gain. Most patients undergoing ASD surgery experienced height gain following deformity correction, with a mean full-body height gain of 7.6 cm. Height gain can be estimated preoperatively with predictive ratios, and height gain was correlated with improvements in reported SRS-22r appearance and PROMIS scores. Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.

Poster 317: Preoperative and Operative Characteristics in the Context of Patient-Reported Outcomes for ACLR in Patients Aged 40 or Older: Allograft versus Autograft

Poster 317: Preoperative and Operative Characteristics in the Context of Patient-Reported Outcomes for ACLR in Patients Aged 40 or Older: Allograft versus Autograft

Poster 364: Prospective Assessment of Outcomes after Femoral Condyle Osteochondral Allograft with Concurrent Meniscus Allograft Transplantation

Objectives: To report outcomes and associated risk factors for treatment failure (revision surgery or conversion to arthroplasty) in a consecutive series of patients undergoing concurrent femoral condyle osteochondral allograft (OCA) and meniscus allograft (MAT) transplantation using advances in tissue preservation and surgical techniques. Methods: Patients who underwent primary femoral condyle OCA transplantation and concomitant MAT (OCAT+MAT) between 2016-2020 with minimum 2-year follow up data regarding complications, failures, adherence, and patient reported outcome measures (PROMs) were analyzed. Patients who required OCA and/or MAT revision or conversion to artificial arthroplasty were defined as treatment failures. Patient reported outcome measures (PROMs) including VAS pain, IKDC, SANE, PROMIS Global Health and Physical Function, were collected at 3 and 6 months and then yearly after transplantation. Fisher’s exact tests were used to compare proportions and repeated measures ANOVA tests were used to compare longitudinal PROMs data for statistically significant (p&lt;0.05) differences. Results: A total of 21 consecutively enrolled patients met inclusion criteria with mean age of 35 (15-54) years and mean BMI of 27 (19-36) kg/m2. OCAT+MAT was performed in the medial compartment in 14 cases and lateral compartment in 7 cases. Realignment osteotomies were performed in 4 cases. Initial success rate (mean follow-up of 44 mos) was 76% based on 1 revision and 4 arthroplasties performed. Overall success rate was 81% based on successful revision. Statistically significant (p&lt;0.002) and clinically meaningful improvements were noted for all measured PROMs (VAS pain, IKDC, SANE, PROMIS) at 2-year follow up. Patients requiring conversion to arthroplasty were significantly older (mean age, 48.3 v 32.2 years, p=0.0076) than patients with successful outcomes. Nonadherence with postoperative restrictions and rehabilitation protocol was an independent risk factor for conversion to arthroplasty (p=0.022, OR=42). Conclusions: Combined femoral condyle OCA and meniscus allograft transplantation was associated with successful short- to mid-term outcomes in 81% of cases. Older age and nonadherenceto postoperative protocols are risk factors for decreased outcomes.

Poster 343: How Does the Literature on Minimum Clinically Important Difference (MCID) Apply to the Patient Population from a Single Center: The Challenge of MCID in Anterior Cruciate Ligament Reconstruction

Objectives: The field of orthopaedic surgery continues to transition towards using patient-reported outcome measures (PROMs) to measure treatment success. Metrics such as the minimum clinically important difference (MCID) can help define treatment success, but there is no clear consensus on the methodology or application of scores in clinical medicine. MCID calculations can vary significantly based on cohort size, methodology (e.g. anchor-based versus distribution-based methods), follow-up time point, and patient-specific factors. Anterior cruciate ligament reconstruction (ACLR) is a highly prevalent procedure that provides high patient satisfaction according to PROMs such as the Knee Injury &amp; Osteoarthritis Outcome Score (KOOS) and the Single Assessment Numerical Evaluation (SANE). Both scales have MCID values reported in the ACLR literature. The purpose of this study was to identify patients that reached the literature-reported MCID values for KOOS and SANE. The secondary aim was to identify if there were any differences in demographic, injury, and treatment characteristics among patients that reach MCID for KOOS and/or SANE and those that do not. Methods: The PROM database of a single ambulatory surgical center was queried for ACLR procedures from 2009-2016. Revision procedures, concomitant ligament repairs/reconstructions, and patients without outcome data at baseline and two-year follow-up were excluded from the study. Demographic, injury, and surgical characteristics were extracted via chart review. Demographics included age, sex, and diagnosis of anxiety and/or depression. Injury characteristics included acuity of injury (≥6 months considered chronic) and presence of meniscal injuries. Surgical characteristics included body mass index (BMI), operative time, American Society of Anesthesiologists (ASA) Score, graft type, implant type, and concomitant meniscal procedures. Outcomes evaluated were KOOS and SANE after two years of ACLR. Patients were grouped according to whether they did or did not meet literature-reported MCIDs for KOOS and/or SANE. One-way analysis of variance and chi-square tests were conducted to identify group differences, with p=0.05 set as the threshold for significance. Results: A total of 322 patients were included. Most were female (62.1%) and had an average age of 28. Average BMI and operative time were 25.3 and 108.3 minutes, respectively. Most patients had an ASA score of 1 (84.1%). A total of 20.5% of patients had a mental health diagnosis of anxiety and/or depression. Most patients received a bone-tendon-bone autograft (49.1%). Only 6.8% of patients presented with a chronic injury. The proportion of patients that achieved MCID at two years for KOOS and SANE were 73.6% and 45.7%, respectively (p&lt;0.00001). The majority of patients achieving SANE MCID achieved KOOS MCID (89.8%), while just 55.7% of patients achieving KOOS MCID achieved SANE MCID. 41.0% of patients achieved MCID for both KOOS and SANE, while 21.7% of patients did not achieve MCID for any scale. Compared to patients that achieved MCID in at least one PROM, there was a significantly higher proportion of patients that underwent ACLR for chronic injuries among those that did not meet MCID (11.4% vs 5.6%, p=0.004). Surgical technique did not statistically differ among patients that achieved MCID and those that did not. Conclusions: The rates of achieving literature-reported MCID values for KOOS and SANE were significantly different within the same cohort of ACLR patients (73.6% for KOOS vs 45.7% for SANE). Only 41.0% of patients achieved MCID for both PROMs. A higher percentage of patients that did not meet MCID had chronic injuries compared to those that met at least one MCID. Treatment success in ACLR as determined by PROMs is thus a function of the tool employed and the injury/patient undergoing treatment rather than the surgery performed. This study particularly found that the timing from injury to presentation was associated with likelihood of achieving MCID. As orthopaedics continues to incorporate PROM data to determine treatment success as well as prior authorization and reimbursement policies, it is important to refine these PROMs and tailor them to patient-specific factors in order to adequately capture a successful treatment. [Table: see text][Table: see text]

Evaluation and acceptability of patient-reported outcome measures in women following pelvic organ prolapse procedures

BackgroundThe Australasian Pelvic Floor Procedure Registry (APFPR) captures clinical and surgical data in women undergoing pelvic floor procedures. The inclusion of patient reported outcome measures (PROMs) in the APFPR is a critical activity providing the additional patient perspective of their condition prior to surgery as well as monitoring beyond the usual post-surgical follow-up time. This study aimed to evaluate the acceptability of seven PROMs for women with pelvic organ prolapse (POP) and to determine the most suitable instrument for the APFPR.MethodsSemi-structured qualitative interviews were conducted with women with POP (n = 15) and their treating clinicians (n = 11) in Victoria, Australia. Interview topics covered appropriateness, content, and acceptability of seven POP-specific instruments identified through the literature to determine their suitability and acceptability for inclusion in the APFPR. We analysed the interview data using conventional content analysis.ResultsAll study participants agreed that PROMs were needed for the APFPR. Both women and clinicians suggested that some of the instruments were ambiguous, too long and confusing. The Australian Pelvic Floor Questionnaire was accepted widely amongst women and clinicians and recommended for inclusion in the APFPR. All participants agreed it would be appropriate to capture PROMs before surgery, and then followed up post-surgically. Email, phone call or postal mail-out were the preferred options for PROMs data collection.ConclusionMost women and clinicians supported incorporating PROMs in the APFPR. Study participants believed that capturing PROMs would have potential use in individual care and improve outcomes of women with POP.

Patient-Reported Outcome Measures in Gender-Affirming Surgery.

Patient-reported outcome measures (PROMs) are questionnaires that assess how patients feel and function. PROMs should be developed and validated using a mixed methods, multistep approach with extensive patient input to ensure that they are easy to understand, comprehensive, and relevant. PROMs that are specific to gender-affirming care (including surgery), such as the GENDER-Q, can be used to educate patients, align patients' goals and preferences with realistic expectations about the surgical procedures' purposes and outcomes, and conduct comparative effectiveness research. PROM data can contribute to evidence-based, shared decision making and just access to gender-affirming surgical care.

Pedi-IKDC exhibits questionable measurement properties in a cohort of pediatric patients with ACL rupture.

Pedi-IKDC is commonly used to evaluate anterior cruciate ligament (ACL) deficiency in children. However, its construct validity has not been thoroughly assessed. The aim was to examine the measurement properties of the Pediatric International Knee Documentation Committee (Pedi-IKDC) by modern test theory (MTT) models, confirmatory factor analysis (CFA), and item response theory (IRT). The cohort consisted of all children and adolescents in Denmark (n = 535, age 9-16) treated with physeal-sparing ACL reconstruction 2011-2020. Patient-reported outcome measure (PROM) data were collected before surgery and at 1 year follow-up. Structural validity of Pedi-IKDC was assessed with MTT models. Reliability was reported as McDonalds coefficient omega. Responsiveness was evaluated with standardized response means. Sufficient PROM data were available for 372 patients. The original unidimensional construct did not fit CFA model expectations neither before surgery (χ2 = 462.0, df = 163, p < 0.0001; RMSEA: 0.109, CFI: 0.910, TFI: 0.895) nor at follow-up. Neither did a two-factor CFA model with "Symptoms" and "Sports activities" as individual subscales (χ2 = 455.6, df = 162, p < 0.0001) nor a bifactor model (χ2 = 338.9, df = 143, p < 0.0001), although fit indices improved with the latter (RMSEA: 0.094, CFI: 0.941, TFI: 0.922). The IRT models confirmed this pattern. The scale was responsive (SRM 1.66 (95% CI: 1.46-1.88)). Coefficient omega values were 0.866 before surgery and 0.919 at follow-up. The Pedi-IKDC exhibited inadequate structural validity. Neither the original construct, a two-factor model, nor bifactor models fitted data well. We advise that data obtained by Pedi-IKDC are interpreted with caution.

Facing the challenges of PROM implementation in Dutch dialysis care: Patients' and professionals' perspectives.

Patient Reported Outcome Measures (PROMs) are increasingly used in routine clinical practice to facilitate patients in sharing and discussing health-related topics with their clinician. This study focuses on the implementation experiences of healthcare professionals and patients during the early implementation phase of the newly developed Dutch set of dialysis PROMs and aims to understand the process of early implementation of PROMs from the users' perspectives. This is a qualitative study among healthcare professionals (physicians and nursing staff: n = 13) and patients (n = 14) of which 12 were receiving haemodialysis and 2 peritoneal dialysis. Semi-structured interviews were used to understand the barriers and facilitators that both professionals and patients encounter when starting to implement PROMs. The early PROM implementation process is influenced by a variety of factors that we divided into barriers and facilitators. We identified four barriers: patient´s indifference to PROMs, scepticism on the benefits of aggregated PROM data, the limited treatment options open to doctors and organizational issues such as mergers, organizational problems and renovations. We also describe four facilitators: professional involvement and patient support, a growing understanding of the use of PROMs during the implementation, quick gains from using PROMs such as receiving instant feedback and a clear ambition on patient care such as a shared view on patient involvement and management support. In this qualitative study carried out during the early implementation phase of the Dutch dialysis PROM set, we found that patients did not yet consider the PROM set to be a useful additional tool to share information with their doctor. This was despite the professionals' primary reason for using PROMs being to improve patient-doctor communication. Furthermore, the perceived lack of intervention options was frustrating for some of the professionals. We found that nurses could be important enablers of further implementation because of their intensive relationship with dialysis patients.

Age-Related Differences in Pain, Function, and Quality of Life Following Primary Total Knee Arthroplasty: Results From a FORCE-TJR (Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement) Cohort

BackgroundThe impact of age on patient outcomes after total knee arthroplasty (TKA) remains controversial. Age has shown no effect on outcome in some studies, while others have reported better or worse outcome in younger patients. The aims of this study were to determine the differences in pain, function, and quality of life (QoL) reported 1 year after TKA across different age groups. MethodsA prospective, multicenter cohort of 11,602 unilateral primary TKA patients was evaluated. Demographic data, comorbid conditions, and patient-reported outcome measures including the knee injury and osteoarthritis outcome score (KOOS), KOOS-12, KOOS Joint Replacement, and Short-Form health survey (12-item) were collected preoperatively and at 1-year postoperatively. Descriptive statistics were generated, stratified by age [<55 years (younger adult), 55 to 64 years (older adult), 65 to 74 years (early elder), and ≥ 75 years (late elder)], and differences in pain, function, and QoL among the 4 age groups were evaluated using Chi-square and Kruskal-Wallis tests. Multivariate regression models with 95% confidence interval were performed to determine if age was predictive for KOOS pain and function scores. ResultsPrior to surgery, younger patients (<55 years) reported worse KOOS pain (39), function (50), and QoL (18) scores with poor mental health score (47) than other older patient groups. The mean preoperative score differences across the age groups in the KOOS total score (9.37), KOOS pain (11.61), KOOS-12 pain (10.14), and KOOS/KOOS-12 QoL (12.60) reached the calculated minimal clinically important difference. At 1 year after TKA, younger patients (<55 years) reported lower KOOS pain, function, and QoL scores when compared to older patients (≥ 75 years). The differences in 1-year postop scores among the 4 age groups (ranging from 4.0 to 12.2) reached the minimal clinically important difference for pain (10.4) and QoL (12.2). Younger patients (<55 years) achieved higher baseline to 1-year pain (36.8 points), function (30.3 points), and QoL (40.7 points) score changes when compared to older patients aged ≥ 75 years. Although statistically significant, the differences in score changes among the age groups were clinically irrelevant. The multivariate regression analyses showed that age was a significant predictor for pain, but not for function at 1 year where KOOS pain score was predicted to be higher (less pain) (β = 6.17; 95% confidence interval 4.12- 8.22) (P < .001) in older patients (≥ 75 years) when compared to younger patients (<55 years). ConclusionA TKA provides a dramatic improvement in pain, function, and QoL in all age groups. However, there are age-related clinically significant differences in preoperative pain, QoL, and mental health and in final postoperative pain and QoL scores with younger patients (<55 years) reporting more pain, less QoL, and worse preoperative mental health. The patient-reported outcome measure data presented here can be used clinically to improve shared decision-making and patient expectations prior to TKA.

Updated Recommendations on Evidence Needed to Support Measurement Comparability Among Modes of Data Collection for Patient-Reported Outcome Measures: A Good Practices Report of an ISPOR Task Force

The ISPOR Task Force on measurement comparability between modes of data collection for patient-reported outcome measures (PROMs) has updated the good practice recommendations from the 2009 ISPOR electronic patient-reported outcome and 2014 patient-reported outcome mixed modes Good Research Practices Task Force reports in light of accumulated evidence of measurement comparability among different modes of PROM data collection. Furthermore, with the increasing use of electronic formats of clinical outcome assessments in clinical trials and the US Food and Drug Administration’s encouragement of electronic data collection, this new task force report provides stakeholders with best practice recommendations reflecting the current body of evidence and enables them to respond to future developments in research and technology.This task force recommends an evidence-based approach to determine whether new research is needed to evaluate measurement comparability for a given questionnaire or technology. The suitability of existing evidence depends upon whether it satisfactorily demonstrates that the change in data collection mode has not affected the PROM’s measurement properties. In cases where sufficient evidence of measurement comparability exists and best practices for faithful migration are followed, this task force concludes that further testing of measurement comparability among the data collection modes is unnecessary, including cases of “mixing modes” within clinical trials such as bring your own device designs.

Evolution of patient-reported outcome measures, 1, 2, and 5 years after surgery for subaxial cervical spine fractures, a nation-wide registry study

BACKGROUND CONTEXTA longer duration of patient follow up arguably provides more reliable data on the long-term effects of a treatment. However, the collection of long-term follow up data is resource demanding and often complicated by missing data and patients being lost to follow up. In surgical fixation for cervical spine fractures, data are lacking on the evolution of patient reported outcome measures (PROMs) beyond 1-year of follow up. We hypothesized that the PROMs would remain stable beyond the 1-year postoperative follow up mark, regardless of the surgical approach. PURPOSETo assess the trends in the evolution of patient-reported outcome measures (PROMs) at 1, 2-, and 5-years following surgery in patients with traumatic cervical spine injuries. STUDY DESIGNNation-wide observational study on prospectively collected data. PATIENT SAMPLEIndividuals treated for subaxial cervical spine fractures with anterior, posterior, or combined anteroposterior approaches, between 2006 and 2016 were identified in the Swedish Spine Registry (Swespine). OUTCOME MEASURESPROMs consisting of EQ-5D-3Lindex and the Neck Disability Index (NDI) were considered. METHODSPROMs data were available for 292 patients at 1 and 2 years postoperatively. Five-years PROMs data were available for 142 of these patients. A simultaneous within-group (longitudinal) and between group (approach-dependent) analysis was performed using mixed ANOVA. The predictive ability of 1-year PROMs was subsequently assessed using linear regression. RESULTSMixed ANOVA revealed that PROMs remained stable from 1- to 2-years as well as from 2- to 5-years postoperatively and were not significantly affected by the surgical approach (p<0.05). A strong correlation was found between 1-year and both 2- and 5-years PROMs (R>0.7; p<0.001). Linear regression confirmed the accuracy of 1-year PROMs in predicting both 2- and 5-years PROMs (p<0.001). CONCLUSIONPROMs remained stable beyond 1-year of follow up in patients treated with anterior, posterior, or combined anteroposterior surgeries for subaxial cervical spine fractures. The 1-year PROMs were strong predictors of PROMs measured at 2, and 5 years. The 1-year PROMs were sufficient to assess the outcomes of subaxial cervical fixation irrespective of the surgical approach.