Patient-reported Outcome Measures Data Research Articles

Clinical effectiveness of tenotomy versus tenodesis for long head of biceps pathology: a systematic review and meta-analysis

ObjectivesThe comparative clinical effectiveness of common surgical techniques to address long head of biceps (LHB) pathology is unclear. We synthesised the evidence to compare the clinical effectiveness of tenotomy versus...

No advantage with navigated versus conventional mechanically aligned total knee arthroplasty—10 year results of a randomised controlled trial

PurposeComputer-assisted surgery (CAS) total knee arthroplasty (TKA) remains a controversial area of surgical practice. The aim of this study is to report the ten-year revision rates and patient-reported outcome measures (PROMS) of a single-blinded, prospective, randomised controlled trial comparing electromagnetically (EM) navigated and conventional TKA.Methods199 patients were randomised to receive either EM navigated or conventional TKA where the aim of implantation was neutral mechanical alignment in all cases. Ten-year revision rates were collated and compared between the two intervention groups. Longitudinal PROMS data was collected prospectively at various time points up to 10 years post-operatively.ResultsOver the ten-year period, there were 23 deaths (22.8%) in the EM navigation cohort and 30 deaths (30.6%) in the conventional cohort. At 10 years post-operatively, there was no statistically significant difference in all cause revision between the EM navigation and conventional cohort (4.0 vs 6.1%, p = 0.429). When analysing causes of revision that might be influenced by utilising EM navigation, there was no statistically significant difference in revisions (3.0% EM navigated vs 4.1% conventional group, p = 0.591). Patients that received navigated TKAs had improved Oxford Knee Society, American Knee Society Score and range of motion at 3 months following surgery compared to conventional TKA (p = 0.002, p = 0.032, and p = 0.05, respectively). However, from 1 to 10 years post-operatively, both interventions had equivalent outcomes.ConclusionThere is no difference in revision rates or clinical outcomes comparing EM navigated versus conventional TKA at ten-year follow-up. The expected mortality rate makes it unlikely that a difference in revision rates will reach statistical significance in the future. In the setting of an experienced knee arthroplasty surgeon, it is difficult to justify the additional costs of CAS in TKA surgery.Level of evidenceI

Misconceiving patient reported outcome measures (PROMs) as primarily a reporting requirement rather than a quality improvement tool: perceptions of independent healthcare sector stakeholders in the UK

BackgroundThe independent healthcare sector in the UK collects PROMs for several surgical procedures, but implementation has been challenging. We aimed to understand the enablers and barriers to PROMs implementation in the independent healthcare sector in the UK.MethodBetween January and May 2021, we remotely conducted semi-structured interviews with hospital consultants, hospital managers and other clinical staff using a topic guide developed from an implementation science framework called the Theoretical Domains Framework (TDF).ResultsWe interviewed 6 hospital consultants, 5 hospital managers, and 3 other clinical staff (1 nurse and 2 physiotherapists) across 8 hospitals. Common barriers included: the perception that PROMs are predominantly a reporting requirement rather than a quality improvement tool, absence of feedback mechanisms for PROMs data for clinicians, poor awareness of PROMs among healthcare professionals and the public, absence of direction or commitment from leadership, and limited support from hospital consultants. Common enablers included: regular feedback of PROMs data to clinicians, designating roles and responsibilities, formally embedding PROMs collection into patient pathways, and involvement of hospital consultants in developing strategies to improve PROMs uptake.ConclusionTo support PROMs implementation, independent hospitals need to develop long-term organisational strategies that involve sustained leadership commitment, goals or targets, training opportunities to staff, and regular feedback of PROMs data at clinical or governance meetings. The primary purpose of PROMs needs to be reframed to independent healthcare sector stakeholders as a quality improvement tool rather than a reporting requirement.

Patients’ perspectives on the benefits of feedback on patient-reported outcome measures in a web-based personalized decision report for hip and knee osteoarthritis

BackgroundApplications of patient-reported outcome measures (PROMs) for individual patient management are expanding with the support of digital tools. Providing PROM-based information to patients can potentially improve care experiences and outcomes through informing and activating patients. This study explored patients’ perspectives on the benefits of receiving feedback on PROMs in the context of a web-based personalized decision report to guide care for their hip or knee osteoarthritis.MethodsThis qualitative descriptive interview study was nested in a pragmatic clinical trial of a personalized report, which includes descriptive PROM scores and predicted postoperative PROM scores. Patients completed a semi-structured interview within 6 weeks of an office visit with an orthopaedic surgeon. Only patients who reported receiving the report and reviewing it with the surgeon and/or a health educator were included. Data were iteratively analyzed using a combination of deductive and inductive coding strategies.ResultsTwenty-five patients aged 49–82 years (60% female, 72% surgical treatment decision) participated and described three primary benefits of the PROM feedback within the report: 1. Gaining Information About My Health Status, including data teaching new information, confirming what was known, or providing a frame of reference; 2. Fostering Communication Between Patient and Surgeon, encompassing use of the data to set expectations, ask and answer questions, and facilitate shared understanding; and 3. Increasing My Confidence and Trust, relating to the treatment outcomes, treatment decision, and surgeon.ConclusionsPatients identified actual and hypothetical benefits of receiving feedback on PROM scores in the context of a web-based decision report, including advantages for those who had already made a treatment decision before seeing the surgeon. Findings provide insight into patients’ perspectives on how digital PROM data can promote patient-centered care. Results should be considered in the context of the homogeneous sample and complex trial. While participants perceived value in this personalized report, questions remain regarding best practices in patient-facing data presentation and engagement.Trial registrationClinicalTrials.gov, NCT03102580. Registered on 5 April 2017.

148. Impact of self-reported loss of balance and gait disturbance on adult spinal deformity surgery outcomes

148. Impact of self-reported loss of balance and gait disturbance on adult spinal deformity surgery outcomes

P136. Predictors of non-improvement after minimally invasive lumbar spine surgery

P136. Predictors of non-improvement after minimally invasive lumbar spine surgery

P137. Preliminary analysis on the influence of workers’ compensation status on outcomes of anterior lumbar interbody fusion at L5-S1

<h3>BACKGROUND CONTEXT</h3> Few studies have focused on outcomes among Workers' Compensation (WC) claimants undergoing anterior lumbar interbody fusion (ALIF). <h3>PURPOSE</h3> To determine the influence of WC on perioperative outcomes, patient-reported outcome measures (PROMs) and attainment rates of minimal clinically important difference (MCID) among patients undergoing single-level ALIF at L5S1. <h3>STUDY DESIGN/SETTING</h3> Retrospective. <h3>PATIENT SAMPLE</h3> A retrospective surgical database of an attending spine surgeon was utilized to identify patients with WC insurance undergoing single-level ALIF at L5S1. One-hundred and nine patients were included, with 82 in the non-WC and 27 in the WC cohort. <h3>OUTCOME MEASURES</h3> PROM data for visual analog scale (VAS) back/leg, Oswestry Disability Index (ODI), 12-Item Short Form (SF-12) Physical Composite Score (PCS) and Patient Reported Outcome Measurement Information System physical function (PROMIS-PF) was obtained preoperatively and at 6-weeks, 12-weeks, 6-months, 1-year and 2-years following ALIF. <h3>METHODS</h3> Patients were divided into groups based on insurance status: WC vs non-WC (including patients with private insurance or Medicare/Medicaid). Demographic and perioperative information was evaluated between insurance groups using student's t-test for independent samples for continuous variables and chi-squared test for categorical variables. Mean PROMs were compared with student's t-test for independent samples. Comparisons of preoperative and postoperative PROM values were evaluated with paired sample t-tests. Patients who achieved an improvement in PROM score greater than or equal to established threshold values were marked as achieving MCID. WC and non-WC groups were compared in MCID attainment rates across PROMs with chi-squared analyses. <h3>RESULTS</h3> A greater proportion of the non-WC cohort were Caucasian, while a significantly greater proportion of the WC cohort were African American and Hispanic (p=0.001). Significantly more patients in the WC cohort were smokers (p<0.001). Non-WC patients improved significantly from preoperative to postoperative timepoints of 6-months through 2-years for PROMIS-PF and SF-12 PCS, 6 weeks through 1 year for VAS back, 6 months/1 year for VAS leg and 12 weeks through 1-year for ODI (p≤0.048, all). WC patients improved significantly at postoperative timepoints for PROMIS-PF at 6 weeks (p=0.029), SF-12 PCS at 12 weeks (p=0.018), VAS back from 6 weeks to 6 months, and VAS leg at 6 months, only (p≤0.029, all). Mean VAS back scores were significantly greater in the WC cohort at 6 months and 1 year (p≤0.013, both), mean VAS leg scores were significantly greater in the WC cohort at 1 year (p=0.029), and mean ODI scores were significantly higher in the WC cohort at preoperative through 1 year (p≤0.040, all). With the exception of higher MCID achievement for VAS back at 12 weeks (p=0.037), no other differences in attainment rates were observed for any PROM at any time point or for the overall postoperative period. <h3>CONCLUSIONS</h3> Among patients receiving ALIF, WC insurance was more prevalent among patients identifying as Hispanic and African American, along with smokers. While physical function scores were similar between groups, long-term pain and disability (throughout the entire postoperative period) were significantly higher among patients with WC. MCID achievement, however, was largely comparable for all PROMs between WC and non-WC study groups. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

What’s New in Hip Replacement

What’s New in Hip Replacement

Evaluating the measures in patient-reported outcomes, values and experiences (EMPROVE study): a collaborative audit of PROMs practice in orthopaedic care in the United Kingdom.

All national orthopaedic societies advocate the use of patient reported outcome measures (PROMs), but clear guidance on their use is limited. We utilised a collaborative methodology to perform a national audit aiming to assess the perceived variability in PROMs practice in orthopaedic surgery in the United Kingdom. A multicentre collaborative audit of practice was performed extracting PROMs data on 21 commonly performed orthopaedic procedures. For each procedure, data were collected for frequency of PROM collection, type of PROM chosen, administration intervals, method and reason for collection. Compliance with national society recommendations was undertaken. Sixty-three trusts enrolled to participate in the study with a completion rate of 60% (38 trusts). The most frequently reported PROMs were those associated with best practice tariffs (83.3% and 80.6% for hip and knee replacements, respectively). Outside incentivised programmes we observed a higher rate of variation in PROMs practice which failed to meet our audit standard. Across all procedures evaluated, 69% (221/318) of respondents to the study used paper as the primary method of PROM collection. This is the first national audit of PROMs collection in orthopaedics. The integration of PROMs within best practice tariff platforms positively influences the frequency and standardisation of collection. Outside this initiative, PROMS collection is infrequent and highly varied despite the presence of several registries. Because PROMs collection is a recommendation across all procedures using implantable devices, the success of this will depend on the adequacy of funding, resource delivery and the presence of clearer recommendations.

Establishing thresholds for meaningful within-individual change using longitudinal item response theory

PurposeThresholds for meaningful within-individual change (MWIC) are useful for interpreting patient-reported outcome measures (PROM). Transition ratings (TR) have been recommended as anchors to establish MWIC. Traditional statistical methods for analyzing MWIC such as mean change analysis, receiver operating characteristic (ROC) analysis, and predictive modeling ignore problems of floor/ceiling effects and measurement error in the PROM scores and the TR item. We present a novel approach to MWIC estimation for multi-item scales using longitudinal item response theory (LIRT).MethodsA Graded Response LIRT model for baseline and follow-up PROM data was expanded to include a TR item measuring latent change. The LIRT threshold parameter for the TR established the MWIC threshold on the latent metric, from which the observed PROM score MWIC threshold was estimated. We compared the LIRT approach and traditional methods using an example data set with baseline and three follow-up assessments differing by magnitude of score improvement, variance of score improvement, and baseline-follow-up score correlation.ResultsThe LIRT model provided good fit to the data. LIRT estimates of observed PROM MWIC varied between 3 and 4 points score improvement. In contrast, results from traditional methods varied from 2 to 10 points—strongly associated with proportion of self-rated improvement. Best agreement between methods was seen when approximately 50% rated their health as improved.ConclusionResults from traditional analyses of anchor-based MWIC are impacted by study conditions. LIRT constitutes a promising and more robust analytic approach to identifying thresholds for MWIC.

Using co-production to implement patient reported outcome measures in third sector organisations: a mixed methods study

BackgroundThird sector organisations such as charities and community groups are using Patient Reported Outcome Measures (PROMs) at an aggregated service level to demonstrate their impact to commissioners to generate or retain funding. Despite this motivation, organisations can struggle with implementing PROMs. Previous studies have identified facilitators including organisations using an appropriate measure, co-producing the PROMs process with staff, and investing resources to support the use of measures. However, to date no studies have applied this learning to third sector organisations to evaluate whether taking an evidence-informed implementation approach improves the use of PROMs.MethodsA Community-Based Participatory Research approach was used which involved university-based researchers supporting two third sector organisations to implement PROMs. The researchers provided evidence-informed advice and training. The organisations were responsible for implementing PROMs. The researchers evaluated implementation through a mixed methods approach including five key informant interviews, four evaluation groups and analysis of collected PROMs data (n = 313).ResultsBoth third sector organisations faced considerable constraints in incorporating known facilitators and addressing barriers. The organisations involved staff in choosing an acceptable measure. However, competing priorities including external pressures to use specific PROMs, busy workloads and staff opinions created challenges to using measures. Investment of time and energy into developing an outcomes-based organisational culture was key to enable the prioritisation of PROMs. For example, discussing PROMs in supervision so that they were viewed as part of people’s job roles. Organisations found that implementation took several years and was disrupted by other pressures.ConclusionsWhilst organisations were motivated to implement PROMs to obtain or retain funding, they faced considerable practical and ideological challenges. Consequently, some stakeholders felt that alternative methods to measuring impact could potentially be more feasible than PROMs.

Patient and Treatment Characteristics Associated With Receipt of Core Patient-Reported Outcome Measures in VA Mental Health.

Measurement-based care (MBC) has been implemented in Veterans Affairs since 2016 and is increasingly used in other mental health care organizations. Little quantitative research exists that assesses patient-level barriers and facilitators of MBC. This study examines correlates of receiving patient-reported outcome measures (PROMs) among veterans receiving both psychotherapy and pharmacotherapy (Both), psychotherapy only (Psychotherapy), and pharmacotherapy only (Pharmacotherapy). Data on PROM administration were obtained for a 12-month period for 1,726,578 veterans who initiated outpatient mental health care during fiscal year 2019. Clinical, treatment, and PROM data were extracted from the electronic health record. Logistic regression was used to model the association between veteran and treatment characteristics and PROM administration. Thirty-two percent of veterans in Both, 26.0% in Psychotherapy, and 8.8% in Pharmacotherapy received at least one PROM. The probability of PROM administration was positively associated with the number of treatment encounters during the fiscal year 2019. Major depressive, generalized anxiety, and other depressive disorders were associated with an increased probability of PROM administration. Psychotic disorders, personality disorders, older age, dementia, and electronic health record suicide risk flag were associated with decreased odds of PROM administration across treatment types. Rates of PROM administration differ depending on the type of treatment received. The probability of PROM administration is influenced by the frequency of encounters and, to a lesser extent, having a diagnosis congruent with symptoms assessed in the set of PROMs considered. Consistent with hypotheses from the MBC implementation literature, potential indicators of clinical severity and cognitive impairment decrease the likelihood of PROM utilization.

Persistent Deficits after an Achilles Tendon Rupture: A Narrative Review.

Persistent muscle weakness, tendon elongation, and incomplete return to preinjury level are frequent sequelae after acute Achilles tendon rupture, and evidence-based knowledge of how to best rehabilitate the injury is largely absent in the literature. The objective of this review is to illuminate and discuss to what extent an Achilles tendon rupture affects muscle, tendon, and function when assessed with the Achilles tendon total rupture score (ATRS), muscle strength, muscle cross-sectional area, tendon length, and the heel-rise test. The patient-reported outcome measures (PROM) data in the literature suggest that the recovery takes longer than 6 months (ATRS, 70 out of 100), that one-year postinjury, the ATRS only reaches 82, and that this does not appear to noticeably improve thereafter. Loss of muscle mass, strength, and function can in some cases be permanent. Over the first 6 months postinjury, the tendon undergoes elongation, which appears to be negatively correlated to heel-rise function. More recently, there has been some interest in how muscle length and excursion is related to the reduced function. The available literature indicates that further research is highly warranted and that efforts to restore normal tendon length may improve the likelihood of returning to preinjury level after an Achilles tendon rupture.

How do Patient-reported Outcome Scores in International Hip and Knee Arthroplasty Registries Compare?

Patient-reported outcome measures (PROMs) are the only systematic approach through which the patient's perspective can be considered by surgeons (in determining a procedure's efficacy or appropriateness) or healthcare systems (in the context of value-based healthcare). PROMs in registries enable international comparison of patient-centered outcomes after total joint arthroplasty, but the extent to which those scores may vary between different registry populations has not been clearly defined. (1) To what degree do mean change in general and joint-specific PROM scores vary across arthroplasty registries, and to what degree is the proportion of missing PROM scores in an individual registry associated with differences in the mean reported change scores? (2) Do PROM scores vary with patient BMI across registries? (3) Are comorbidity levels comparable across registries, and are they associated with differences in PROM scores? Thirteen national, regional, or institutional registries from nine countries reported aggregate PROM scores for patients who had completed PROMs preoperatively and 6 and/or 12 months postoperatively. The requested aggregate PROM scores were the EuroQol-5 Dimension Questionnaire (EQ-5D) index values, on which score 1 reflects "full health" and 0 reflects "as bad as death." Joint-specific PROMs were the Oxford Knee Score (OKS) and the Oxford Hip Score (OHS), with total scores ranging from 0 to 48 (worst-best), and the Hip Disability and Osteoarthritis Outcome Score-Physical Function shortform (HOOS-PS) and the Knee Injury and Osteoarthritis Outcome Score-Physical Function shortform (KOOS-PS) values, scored 0 to 100 (worst-best). Eligible patients underwent primary unilateral THA or TKA for osteoarthritis between 2016 and 2019. Registries were asked to exclude patients with subsequent revisions within their PROM collection period. Raw aggregated PROM scores and scores adjusted for age, gender, and baseline values were inspected descriptively. Across all registries and PROMs, the reported percentage of missing PROM data varied from 9% (119 of 1354) to 97% (5305 of 5445). We therefore graphically explored whether PROM scores were associated with the level of data completeness. For each PROM cohort, chi-square tests were performed for BMI distributions across registries and 12 predefined PROM strata (men versus women; age 20 to 64 years, 65 to 74 years, and older than 75 years; and high or low preoperative PROM scores). Comorbidity distributions were evaluated descriptively by comparing proportions with American Society of Anesthesiologists (ASA) physical status classification of 3 or higher across registries for each PROM cohort. The mean improvement in EQ-5D index values (10 registries) ranged from 0.16 to 0.33 for hip registries and 0.12 to 0.25 for knee registries. The mean improvement in the OHS (seven registries) ranged from 18 to 24, and for the HOOS-PS (three registries) it ranged from 29 to 35. The mean improvement in the OKS (six registries) ranged from 15 to 20, and for the KOOS-PS (four registries) it ranged from 19 to 23. For all PROMs, variation was smaller when adjusting the scores for differences in age, gender, and baseline values. After we compared the registries, there did not seem to be any association between the level of missing PROM data and the mean change in PROM scores. The proportions of patients with BMI 30 kg/m 2 or higher ranged from 16% to 43% (11 hip registries) and from 35% to 62% (10 knee registries). Distributions of patients across six BMI categories differed across hip and knee registries. Further, for all PROMs, distributions also differed across 12 predefined PROM strata. For the EQ-5D, patients in the younger age groups (20 to 64 years and 65 to 74 years) had higher proportions of BMI measurements greater than 30 kg/m 2 than older patients, and patients with the lowest baseline scores had higher proportions of BMI measurements more than 30 kg/m 2 compared with patients with higher baseline scores. These associations were similar for the OHS and OKS cohorts. The proportions of patients with ASA Class at least 3 ranged across registries from 6% to 35% (eight hip registries) and from 9% to 42% (nine knee registries). Improvements in PROM scores varied among international registries, which may be partially explained by differences in age, gender, and preoperative scores. Higher BMI tended to be associated with lower preoperative PROM scores across registries. Large variation in BMI and comorbidity distributions across registries suggest that future international studies should consider the effect of adjusting for these factors. Although we were not able to evaluate its effect specifically, missing PROM data is a recurring challenge for registries. Demonstrating generalizability of results and evaluating the degree of response bias is crucial in using registry-based PROMs data to evaluate differences in outcome. Comparability between registries in terms of specific PROMs collection, postoperative timepoints, and demographic factors to enable confounder adjustment is necessary to use comparison between registries to inform and improve arthroplasty care internationally. Level III, therapeutic study.

Community-based outpatient cancer rehabilitation services for women with gynecologic cancer: acceptability and impact on patient-reported outcomes.

Women with gynecologic cancers often experience functional impairments impacting quality of life. Physical and occupational therapy (PT/OT) treat functional impairment; however, the acceptability and impact of these services for women with gynecologic cancer are unknown. We reviewed rehabilitation charts of women with gynecologic cancer who received PT/OT (i.e., patients) in 2019 and completed patient-reported outcome measures (PROMs) selected by their therapist at intake (pre) and discharge (post). We calculated descriptive statistics for patient, rehabilitation, and acceptability (0-10) data. For PROM data, we used paired samples t-tests to evaluate pre-post change, and then calculated effect size (Hedge's g) and the proportion who achieved a minimal detectable change (MDC). PT/OT patients (N = 84) were 64.63 ± 11.04years old with predominant diagnoses of ovarian (41.7%) or endometrial (32.1%) cancer. They attended a median of 13 sessions (IQR = 8.0-19.0). Sessions were predominantly PT (86%) vs. OT (14%). Median acceptability was 10 (IQR = 9.8-10.0). Pre-post improvement was observed for each of the 17 PROMs used by therapists. Significant improvement (p < .05) was observed for four PROMs: the Patient-Specific Functional Scale (M∆ = 2.93 ± 2.31, g = 1.47, 71% achieved MDC), the Lower Extremity Functional Scale (M∆ = 12.88 ± 12.31, g = 0.61, 60% achieved MDC), the Lymphedema Life Impact Scale (M∆ = 20.50 ± 20.61, g = 1.18, 58% achieved MDC), and the Modified Fatigue Impact Scale (M∆ = 6.55 ± 9.69, g = 0.33, 7% achieved MDC). PT/OT was acceptable and improved patient-reported outcomes for women with gynecologic cancers. Future research is needed to establish gynecologic-specific guidelines for referral and PT/OT practice.

Use of computerised adaptive testing to reduce the number of items in patient-reported hip and knee outcome scores: an analysis of the NHS England National Patient-Reported Outcome Measures programme

ObjectiveOver 160 000 participants per year complete the 12-item Oxford Hip and Knee Scores (OHS/OKS) as part of the NHS England Patient-Reported Outcome Measures (PROMs) programme. We used a modern...

Poor Knee-specific and Generic Patient-reported Outcome Measure Scores at 6 Months Are Associated With Early Revision Knee Arthroplasty: A Study From the Australian Orthopaedic Association National Joint Replacement Registry.

The ability to identify which patients are at a greater risk of early revision knee arthroplasty has important practical and resource implications. Many international arthroplasty registries administer patient-reported outcome measures (PROMs) to provide a holistic assessment of pain, function, and quality of life. However, few PROM scores have been evaluated as potential indicators of early revision knee arthroplasty, and earlier studies have largely focused on knee-specific measures. This national registry-based study asked: (1) Which 6-month postoperative knee-specific and generic PROM scores are associated with early revision knee arthroplasty (defined as revision surgery performed 6 to 24 months after the primary procedure)? (2) Is a clinically important improvement in PROM scores (based on thresholds for the minimal important change) after primary knee arthroplasty associated with a lower risk of early revision? Preoperative and 6-month postoperative PROM scores for patients undergoing primary knee arthroplasty were sourced from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and Arthroplasty Clinical Outcomes Registry National. Between January 2013 and December 2020, PROM data were available for 19,402 primary total knee arthroplasties; these data were linked to AOANJRR data on revision knee arthroplasty. Of these, 3448 procedures were excluded because they did not have 6-month PROM data, they had not reached the 6-month postoperative point, they had died before 24 months, or they had received revision knee arthroplasty before the 6-month PROMs assessment. After these exclusions, data were analyzed for 15,954 primary knee arthroplasties. Associations between knee-specific (knee pain, Oxford Knee Score, and 12-item Knee injury and Osteoarthritis Outcome Score [KOOS-12]) or generic PROM scores (5-level EuroQol quality of life instrument [EQ-5D], EQ VAS, perceived change, and satisfaction) and revision surgery were explored using t-tests, chi-square tests, and regression models. Ninety-four revision procedures were performed at 6 to 24 months, most commonly for infection (39% [37 procedures]). The early revision group was younger than the unrevised group (mean age 64 years versus 68 years) and a between-group difference in American Society of Anesthesiologists (ASA) grade was noted. Apart from a small difference in preoperative low back pain for the early revision group (mean low back pain VAS 4.2 points for the early revision group versus 3.3 points for the unrevised group), there were no between-group differences in preoperative knee-specific or generic PROM scores on univariate analysis. As the inclusion of ASA grade or low back pain score did not alter the model results, the final multivariable model included only the most clinically plausible confounders (age and gender) as covariates. Multivariable models (adjusting for age and gender) were also used to examine the association between a clinically important improvement in PROM scores (based on published thresholds for minimal important change) and the likelihood of early revision. After adjusting for age and gender, poor postoperative knee pain, Oxford, KOOS-12, EQ-5D, and EQ VAS scores were all associated with early revision. A one-unit increase (worsening) in knee pain at 6 months was associated with a 31% increase in the likelihood of revision (RR 1.31 [95% confidence interval (CI) 1.19 to 1.43]; p < 0.001). Reflecting the reversed scoring direction, a one-unit increase (improvement) in Oxford or KOOS-12 score was associated with a 9% and 5% reduction in revision risk, respectively (RR for Oxford: 0.91 [95% CI 0.90 to 0.93]; p < 0.001; RR for KOOS-12 summary: 0.95 [95% CI 0.94 to 0.97]; p < 0.001). Patient dissatisfaction (RR 6.8 [95% CI 3.7 to 12.3]) and patient-perceived worsening (RR 11.7 [95% CI 7.4 to 18.5]) at 6 months were also associated with an increased likelihood of early revision. After adjusting for age and gender, patients who did not achieve a clinically important improvement in PROM scores had a higher risk of early revision (RR 2.9 for the knee pain VAS, RR 4.2 for the Oxford Knee Score, RR 6.3 to 8.6 for KOOS-12, and RR 2.3 for EQ-5D) compared with those who did (reference group). Knee-specific and generic PROM scores offer an efficient approach to identifying patients at greater risk of early revision surgery, using either the 6-month score or the magnitude of improvement. These data indicate that surgeons can use single- and multi-item measures to detect a patient-perceived unsuccessful surgical outcome at 6 months after primary knee arthroplasty. Surgeons should be alert to poor PROM scores at 6 months or small improvements in scores (for example, less than 2 points for knee pain VAS or less than 10.5 points for Oxford Knee Score), which signal a need for direct patient follow-up or expedited clinical review. Level III, therapeutic study.

Clinical and Radiographic Outcomes of Revision Total Ankle Arthroplasty Using the INBONE II Prosthesis.

The literature on the outcome of revision total ankle arthroplasty (TAA) remains limited. In this study, we aimed to report the clinical and radiographic outcomes of revision TAA at a high-volume center in the United Kingdom. This study was a retrospective review of 28 patients who underwent 29 revision TAAs using the INBONE II Total Ankle System (Wright Medical Technology/Stryker). Demographic, radiographic, and patient-reported outcome measure data were analyzed. The mean duration from primary TAA to revision was 87.5 months (range, 16 to 223 months). The main indication for the revision was aseptic loosening after the primary TAA (83%). Additional procedures were required in 76% of ankles. At a mean follow-up of 40 months (range, 24 to 60 months), the infection rate was 7%, the reoperation rate was 7%, and the implant survival rate was 97%. A significant postoperative improvement in the radiographic component alignment measures was observed. The subsidence, loosening, and heterotopic ossification rates in this study were comparable with those in other reports and did not influence the clinical outcome. A significant improvement was observed in the Manchester-Oxford Foot Questionnaire (MOXFQ) in all domains and the EuroQol-5 Dimensions (EQ-5D) in 3 domains at 24 months postoperatively. Revision TAA using the INBONE II prosthesis was associated with good short-term survival and improvement in postoperative scores at 2 years. Maintenance of the postoperatively improved alignment was documented at the follow-up. The results of this study support the notion that revision TAA is a satisfactory option for failed primary TAA. Therapeutic Level IV . See Instructions for Authors for a complete description of levels of evidence.

Predicting factors for better outcomes of stable supination external rotation type 2 ankle fractures

PurposeStable Weber B ankle fractures are treated by a walking boot for 6 weeks and bearing full weight through the boot as tolerated. The aim of the present study was to assess the outcome parameters of this treatment protocol, evaluate the efficacy of using the walking boot, and investigate any possible predicting factors that could affect the outcomes. MethodsAll the patients with stable Weber B ankle fractures, treated in our hospital between January 2018 and December 2018, were prospectively included to the study. The patients were evaluated clinically, and the patient-reported outcome measures data were collected at the 2 and 6 weeks post-injury. Chi square, Spearman's rho test, independent samples and paired sample t-tests were used for the monovariant analysis. ResultsA total of 128 consecutive patients (aged 52.2 ± 19.1 years) with supination external rotation type 2 fracture were finally included to the study. At the 2 weeks follow-up, the reported outcome measures scores were in moderate levels, but improved significantly at the 6 weeks follow-up (p < 0.0001). Multivariant analysis revealed that the ability to bear full weight without the boot at the 2 weeks after diagnosis was the only variable, which made statistically unique contribution to the foot and ankle disability index score at the 6 weeks (p = 0.005). ConclusionConservative treatment using a walking boot with advice to bear full weight of stable ankle Weber B fractures can bring to good functional outcomes. The ability to bear full weight without the aid of the walking boot at 2 weeks after diagnosis was the only significant predicting factor for better outcomes at 6 weeks after diagnosis.

Preventing clinical deterioration in cancer outpatients: Human centered design of a predictive model and response system.

e13567 Background: Patients (pts) with cancer in the outpatient setting are at a high-risk for adverse events, such as unplanned hospitalizations and ER visits. A recent study found that up to 30% of hospital admissions were preventable. Identifying pts at risk of avoidable clinical deterioration remains a challenge, as clinicians may not be aware of pts’ experiences at home. The growing use of health IT presents an opportunity to identify and respond to clinical deterioration in patients before an adverse event occurs. In this study, we describe a human-centered design (HCD) process used to develop a clinical deterioration risk prediction system to improve the detection of and response to deterioration in cancer outpatients. Methods: Predictive model: We enrolled eligible cancer pts and collected data from each one including: FitBit, geolocation, EHR, and weekly patient-reported outcome measures (PROMs). Pts and their family caregivers could also report non-routine events (NREs), defined as any deviation from expected optimal care. We also captured unplanned treatment events (UTEs), a clinically meaningful change in the pt’s treatment course or care pathway. We developed a predictive model that generates a pt’s 7-day risk of clinical deterioration. Response system: We are developing a risk communication system (RCS) to communicate predicted risk scores to clinical teams. Using a HCD process, we first conducted 36 observations across 100 patient encounters to understand the environment of use. Next, we conducted 18 clinician interviews to define user needs. We have conducted 7 multi-disciplinary design sessions to iteratively develop prototypes of the RCS. We are currently conducting formative usability testing to assess the prototype and gather clinician feedback. Results: Predictive model: We have enrolled 36 cancer outpatients (24 head &amp; neck, 9 gastrointestinal, and 3 lung). Pts completed a total of 219 weekly PROM surveys, reported 107 NREs and experienced 18 UTEs (e.g., infection). So far, models using EHR and PROM data are the most sensitive and precise (AUC: 0.983; 0.999). More patient data are required to develop higher quality stable models. Response system: We identified key design elements to include in the RCS, such as the caregiver’s phone number and the pt’s weight over time. Preliminary findings demonstrate high usability of the prototype RCS. Oncologists identified opportunities for the system to better support team communication and coordination, and to improve the identification and response to clinical deterioration in cancer outpatients. Conclusions: We have developed and tested a clinical deterioration risk prediction system for cancer outpatients. Future studies will implement the response system and evaluate its impact on clinical care.