Subjective Patient-reported Outcome Measures Research Articles

Influence of Concomitant Meniscal Allograft Transplantation on Midterm Outcomes After Osteochondral Allograft Transplantation: A Comparative Matched-Pair Analysis.

Osteochondral allograft transplantation (OCAT) is an accepted knee joint-preserving treatment strategy for focal osteochondral lesions that is often conducted in combination with meniscal allograft transplantation (MAT). Despite its frequent and simultaneous utilization, there remains a lack in the literature reporting on outcomes and failure rates after concomitant procedures. To determine (1) the midterm clinical success rate after OCAT+MAT in comparison with a matched-pair cohort undergoing isolated OCAT, (2) whether patient-specific and procedural variables influence the risk of failure, and (3) patient-reported outcome measures over time. Cohort study; Level of evidence, 3. A single-center matched-pair cohort study was conducted investigating outcomes in patients who underwent OCAT of the medial or lateral femoral condyle with and without MAT between 2004 and 2020. Patients were matched 1:1 by age (±5 years), sex (male or female), body mass index (±5), and grouped Kellgren and Lawrence grade (grades 0-1 or 2-4). The minimum follow-up time was 2 years. Radiographic variables (International Cartilage Regeneration & Joint Preservation Society [ICRS] grade and Kellgren and Lawrence grade) were assessed preoperatively and at follow-up. Subjective patient-reported outcome measures (Lysholm score, Knee injury and Osteoarthritis Outcome Score [KOOS] including subscores, International Knee Documentation Committee [IKDC] score, and visual analog scale score) were collected preoperatively and at follow-up. Clinical failure was defined as revision surgery for graft failure or conversion to total knee arthroplasty. Patient-reported, clinical, and radiographic outcomes were compared between groups. In total, 66 patients (33 treated with isolated OCAT, 33 treated with OCAT+MAT; 57.6% male) with a mean age of 26.3 years (range, 18-62 years) were followed for a mean of 5.6 years (minimum, 2 years; range, 24-218 months). The 2 cohorts showed no difference in Kellgren and Lawrence grade postoperatively (P = .59). There was a significantly higher ICRS grade detected at follow-up in the OCAT+MAT group (2.81 ± 1.10) compared with the OCAT group (2.04 ± 0.96) (P < .05). There were no statistically significant differences between the groups regarding reoperation rate (OCAT: n = 6; OCAT+MAT: n = 13; P = .116), time to reoperation (OCAT: 46.67 ± 47.27 months vs OCAT+MAT: 28.08 ± 30.16 months; P = .061), and failure rate (OCAT: n = 4 [12.1%] vs OCAT+MAT: n = 5 [15.2%]; P = .66). In the OCAT+MAT group, an increase of tibial slope by 1° conferred a 1.65-fold increase in the hazard for failure over decreased slope (hazard ratio, 1.65; 95% CI, 1.10-2.50; P < .05). The overall survival rate was 86% at a mean follow-up of 5.6 years. Patient-reported outcome scores were significantly improved at the final follow-up compared with preoperative status. No significant differences were seen between groups with respect to subjective IKDC, Lysholm, Tegner, and KOOS results, except for the KOOS Symptoms subscale score, which was significantly higher in the OCAT+MAT group than in the OCAT group (mean difference, 14.6; P < .05) and did exceed the minimal clinically important difference threshold of 10.7. Midterm results after isolated OCAT and OCAT+MAT show high rates of healing and sustainable subjective improvement of knee function and quality of life. However, it should be noted that the difference in reoperation rate and time to reoperation between the groups is arguably clinically important and that lack of statistical significance may be because of low power. These results imply that isolated OCAT is an efficient joint-preserving treatment that can be combined with MAT in well-selected patients with meniscal insufficiency without negative influence on global clinical outcomes.

Achieving satisfactory functional outcomes in conservatively treated proximal humerus fractures: relationship between shoulder range of motion and patient-reported clinical outcome scores

Proximal humerus fractures are common osteoporotic fractures. Postinjury outcome measures include objective clinician-measured range of motion (ROM) and subjective patient-reported outcome measures (PROMs), but the relationship between both has not been established. This study aimed to determine the relationship between shoulder ROM and PROMs and establish which ROMs correlated most with PROMs. A prospective cohort study was conducted on patients with acute proximal humerus fractures. Surgical intervention, open or pathological fractures, neurovascular compromise, polytrauma, or delayed presentations were excluded. Correlation and regression analyses between active ROM and PROMs (Quick Disabilities of Arm, Shoulder and Hand [QuickDASH] and Oxford Shoulder Score [OSS]) at 1-year postinjury were explored. ROM cutoffs predicting satisfactory PROM scores were established. Fifty-five patients were recruited. Moderate correlations were observed between PROMs and flexion, extension, and abduction, but not internal and external rotation. Multivariate analysis showed significant relationships between PROMs and flexion [QuickDASH: adjusted coefficient (AC):-0.135, P=.013, OSS: AC: 0.072, P=.002], abduction [QuickDASH: AC:-0.115, P=.021, OSS: AC: 0.059, P=.005], and extension [QuickDASH: AC:-0.304, P=.020] adjusting for age, gender, Neer classification, injury on dominant side, and employment. Achieving 130° flexion, 59° extension, and 124° abduction were correlated with satisfactory OSS/QuickDASH scores, respectively. Overall, holistic assessment of outcomes with both subjective and objective outcomes are necessary, as shoulder flexion, extension, and abduction are only moderately correlated with PROMs. Attaining 130° flexion, 59° extension, and 124° abduction corresponded with satisfactory functional outcomes measured by OSS/QuickDASH and can guide rehabilitation.

Survivorship of 157 Arthroscopic Meniscal Allograft Transplants Using Bone Fixation at a Mean of 7 Years and Prognostic Factors Analysis

Background: Meniscal allograft transplantation (MAT) is an accepted and effective treatment option in the context of unsalvageable menisci, particularly in young and active patients. It has been shown to reduce pain and improve knee function in previously symptomatic patients. However, there is still limited knowledge about the long-term survival rates of allografts, the durability of clinical results, and the influence of patient-specific parameters, such as leg alignment, tibial slope, and preoperative International Cartilage Regeneration & Joint Preservation Society (ICRS) grade. Purpose: To determine (1) the long-term clinical success rate after MAT with bony fixation in a large, single-center cohort of consecutive patients, and (2) if patient-specific and procedural variables influence the clinical, anatomic, and subjective outcomes and risk of failure. Study Design: Case-control study; Level of evidence, 3. Methods: Data on 185 consecutive knees undergoing MAT in a single institution were prospectively collected and screened for inclusion in this study. The minimum follow-up time was 2 years. Radiographic variables (ICRS grade and Kellgren-Lawrence grade) were assessed preoperatively and at follow-up. Subjective patient-reported outcome measures (PROMs) (Lysholm score, Knee injury and Osteoarthritis Outcome Score [KOOS] including subscores, International Knee Documentation Committee [IKDC] score, and visual analog scale [VAS] score) were collected preoperatively and at follow-up. Clinical failure was defined as revision surgery due to graft failure or conversion to total knee arthroplasty. Anatomic failure was considered a tear covering >20% of the allograft, any peripheral tear, and unstable peripheral fixation leading to dislocation of the graft. Subjective failure was defined as Lysholm score ≤65. Preoperative tibial slope and leg alignment were assessed. Survival analyses were performed using the Kaplan-Meier estimate. Univariate and multivariate analyses were performed to determine risk factors for clinical and anatomic failure. Results: A total of 157 knees met inclusion criteria. After a mean follow-up time of 7 ± 3.5 years, 127 (80.9%) knees were free of clinical, anatomic, and subjective failure. Fourteen (8.9%) knees experienced clinical failure, 26 (16.6%) knees were identified as having experienced anatomic failure, and 13 (8.3%) patients experienced subjective failure with a reported Lysholm score of ≤65 at a mean follow-up of 7 years. Concurrent osteochondral allograft transplantation was identified as a predictor of both clinical (hazard ratio [HR], 4.55; 95% CI, 1.46-14.17; P = .009) and anatomic (HR, 3.05; 95% CI, 1.34-6.92; P = .008) failure. Cartilage damage of ICRS grade 3 or 4 of the index compartment conveyed an increased risk for clinical (HR, 3.41; 95% CI, 1.05-11.01; P = .04) and anatomic (HR, 3.04; 95% CI, 1.31-7.11; P = .01) failure. High-grade cartilage damage preoperatively (HR, 10.67; 95% CI, 1.037-109.768; P = .046), patient age >25 years (HR, 5.44; 95% CI, 0.120-246.070; P = .384), and a body mass index >30 (HR, 2.24; 95% CI, 0.748-6.705; P = .149) were associated with subjective failure. PROMs including KOOS and IKDC were significantly improved at final follow-up compared with preoperative scores across all measurements (P < .005). Conclusion: MAT showed good to excellent clinical results at a mean follow-up of 7 years. Low ICRS lesion grade was associated with a higher clinical and anatomic survival rate. Patients with concurrent OCA transplantation are at a higher risk of clinical and anatomic failure, but still report significantly improved PROMs. These results suggest that MAT has a lasting beneficial effect both in isolation and in complex cases with ≥1 concurrent procedures.

Wearable sensor-based measures of step-up transfers are supplementary to patient-reported outcome measures following total joint arthroplasty

Purpose This study investigated the longitudinal assessment of step-up performance in patients undergoing total joint arthroplasty (TJA) and correlation with subjective patient reported outcome measures (PROMs). Methods In this sub-analysis of the ADAPT study, PROMs were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Block step-up (BS) transfers were assessed by wearable-derived measures of time. 76 patients undergoing TJA were included. Subgroups were formed isolating the worst performing quartile (low functioning (LF)) from the high functioning (HF), and outcomes were compared– Results One-year post-surgery, WOMAC function demonstrated strong correlations to WOMAC pain (Pearson’s r = 0.67–0.84) and moderate correlations to BS performance (Pearson’s r = 0.31–0.54). Both WOMAC and BS significantly improved with a larger effect size for the HF subgroup (0.62 vs. 0.43; p < 0.05). Patients designated to the LF subgroup at 3 months had increased odds of representing the LF subgroup at 12 months (WOMAC = 19; BS = 4). WOMAC defined 18 LF patients at 12 months follow-up. BS performance identified 9 additional LF patients. Conclusions WOMAC function scores seem pain dominated. Measures of BS performance allow assessment of otherwise hidden residual functional impairment. Lower functioning 3 months post-surgery is predictive of longer-term impairment.

Single-Institution Prospective Evaluation of Moderately Hypofractionated Whole-Breast Radiation Therapy With Simultaneous Integrated Boost With or Without Lymphatic Drainage Irradiation After Breast-Conserving Surgery

We report treatment outcomes for patients who received adjuvant moderate hypofractionated whole-breast radiation therapy with simultaneous integrated boost (SIB-mhWBRT) after breast-conserving surgery. SIB-mhWBRT for patients with breast cancer was introduced in our department in July 2017. This prospective evaluation includes 424 consecutive patients treated with SIB-mhWBRT for stage I-III invasive breast cancer (n=391) and/or ductal carcinoma in situ (n=33) until December 2021. SIB-mhWBRT was applied with 40 Gy in 15 daily fractions over 3 weeks according to the START B trial, with an SIB dose to the tumor bed of 48 Gy according to Radiation Therapy Oncology Group 1005/UK-IMPORT-HIGH, delivered as 3-dinemsional conformal radiation therapy (RT; n=402), intensity modulated RT (n=4), or volumetric modulated arc therapy (n=18). The mean patient age was 60 years (range, 27-88). Since May 2018, patients with indications for lymphatic pathway RT were included (n=62). Baseline parameters and follow-up data were recorded and reported, including objective assessment of treatment-related outcomes and subjective patient-reported outcome measures (PROMs). Mean/median follow-up was 29/33 months (range, 2-60). Acute toxicity grade 0, 1, 2, and 3 was observed in 25.0%, 61.4%, 13.3%, and 0%, respectively, at the completion of RT. Data of 281, 266, 243, 172, and 58 patients were available for 6-month and 1-, 2-, 3-, and 4-year follow-up, respectively. Grade 2 late effects were identified in 8.5%, 6.0%, 4.9%, 2.2%, and 10.2% and grade 3 in 2.8%, 1.1%, 1.2%, 0%, and 0% of patients at 6-month and 1-, 2-, 3-, and 4-year follow-up, respectively. Medical treatment of breast edema was the only grade 3 late effect observed. PROM cosmesis results were evaluated as excellent-good, fair, and poor in 97.2%, 2.5%, and 0.4%; 96.5%, 3.1%, and 0.4%; 97.4%, 2.2%, and 0.4%; 97.5%, 2.5%, and 0%; and 96.5%, 3.5%, and 0.0% at 6 months and 1, 2, 3, and 4 years post-RT, respectively. For all patients, the 3-year overall, cancer-specific, and disease-free survival rates were 98.2%, 99.1%, and 95.9%, respectively. Three-year risk of any locoregional recurrence was 0.6%. No mortality or relapse was observed in patients with ductal carcinoma in situ. SIB-mhWBRT demonstrated very favorable side effect profiles and cosmesis/PROMs. Three-year results demonstrate excellent locoregional control. This short-term regimen offers substantial patient comfort and improves institutional efficacy.

Objective outcome measures may demonstrate continued change in functional recovery in patients with ceiling effects of subjective patient-reported outcome measures after surgery for lumbar degenerative disorders

Background ContextThe 6-minute walking test (6WT) has been previously shown to be a reliable and valid outcome measure. It is unclear if the 6WT may further help to detect differences in well performing patients that reach a ceiling effect in PROMs after surgery. PurposeTo evaluate changes and timing of change in objective functional impairment (OFI) as measured with the smartphone-based 6WT in relation to patient-reported outcome measures (PROMs) after surgery for degenerative lumbar disorders (DLD). Study designProspective observational cohort study. Patient SampleFifty consecutive patients undergoing surgery for DLD. Outcome MeasuresPatients self-determined their OFI using the 6WT application (6WT-app) and completed a set of paper-based PROMs before, 6 weeks and 3 months after surgery. MethodsFifty patients undergoing surgery for DLD were assessed preoperatively (baseline), 6 weeks (6W) and 3 months (3M) postoperatively. Paired sample t-tests were used to establish significant changes in raw 6-minute walking distance (6WD) and standardized Z-scores, as well as PROMs. Pearson correlation coefficient was used to define the relationship between 6WT and PROMs. Floor and ceiling effects were assessed for each PROM (visual analogue scale [VAS], core outcome measure index [COMI], Zurich claudication questionnaire [ZCQ]). ResultsMean 6WT results improved from 377 m (standard deviation - SD 137; Z-score: 1.8, SD 1.8) to 490 m (SD 126; -0.7, SD 1.5) and 518 m (SD 112; -0.4, SD 1.41; all p<.05) at 6W and 3M follow-up. No significant improvement was observed between 6W and 3M for the ZCQ, VAS back and leg pain. While correlation between 6WT and all PROMs were weak at baseline, correlation coefficient increased to moderate at 3M. A considerable ceiling effect (best possible score) was observed, most notably for the ZCQ physical performance, VAS back and leg pain in 24%, 20%, and 16% of patient at 6W and in 30%, 24%, and 28% at 3M. ConclusionSObjective functional tests can describe the continued change in the physical recovery of a patient and may help to detect differences in well performing groups as well as in cases where patients' PROM results cannot further improve because of a ceiling effect.

126 Objective Functional Outcome Measures Expose Relevant Ceiling Effects Inherent to Subjective Patient-Reported Outcome Measures in Patients Undergoing Surgery for Lumbar Degenerative Disorders

INTRODUCTION: Patient-reported outcome measures (PROMs) may be subject to relevant floor and ceiling effects which may induce substantial bias to the outcome assessment after spine surgery. METHODS: In a prospective study, 50 patients were assessed preoperatively, 6-weeks and 3-months postoperatively for objective functional impairment using the smartphone-based 6-minute walking test (6WT) as well as a set of widely used PROMs. Paired sample t-tests were used to establish significant difference between the changes in raw 6-minute walking distance (6WD) and PROMs at baseline, 6-weeks and 3-months follow-up. Floor and ceiling effect were considered present if &gt;15% achieved the worst and best status. Pearson correlation coefficients were used to define the relationship between 6WT and PROMs at 6-weeks and 3-months. RESULTS: The mean 6WD improved from 377 m preoperative to 490 m and 517 m at 6-weeks and 3-months follow-up (p &lt; 0,05). While all PROMs improved from pre- to six-week postoperative, no significant improvement was observed beyond the 6-weeks follow up in the Core Outcome Measure Index (COMI), the Zurich Claudication Questionnaire (ZCQ) Symptoms Severity Scale, the ZCQ Physical Performance Scale, VAS Back and Leg pain. A ceiling effect was observed for the COMI, the ZCQ Symptoms Severity Scale, the ZCQ Physical Performance Scale, VAS back and VAS leg pain in 2%, 4%, 24%, 20% and 16% of patient at the 6-weeks follow up. Correlation between the 6WD and PROMs significantly increased from the 6-weeks to 12-weeks follow up. CONCLUSIONS: PROMs reach their best possible score in a relevant number of patients early after surgery for DLD while objective functional outcome continues to improve beyond the 6-weeks follow-up. Objective measures of function may expose relevant ceiling effects observed by PROMs and describe the continued recovery of patient.

Assessment of the masseter stiffness in patients during conservative therapy for masticatory muscle disorders with shear wave elastography

BackgroundThe complex structure of the stomatognathic system plays a vital role in chewing, digestion, speaking, breathing, facial expression and swallowing. Its complexity is the primary reason for creating multidisciplinary teams to manage temporomandibular disorders (TMD). We aimed to assess the masseter stiffness in patients undergoing conservative therapy for masticatory muscle disorders and evaluate the efficacy of manual therapy and stabilization occlusal splint in the treatment of masticatory muscle disorders.MethodsThis uncontrolled prospective cohort study included 35 patients with masticatory muscle disorders. The study lasted for eight weeks. The patients were treated with manual therapy and stabilization occlusal splint and evaluated using shear wave elastography of the masseter muscles and patient-reported outcome measures (PROMs) to assess pain, anxiety, quality of sleep, satisfaction with life and perceived stress.ResultsAfter the treatment, the stiffness of both masseter muscles decreased significantly (by 4.21 kPa). The patients reported a significant reduction in pain. At baseline, the median scores ranged from 5 to 8; after treatment, they ranged from 0 to 1 (p < 0.0001). The patients also reported significant improvement in terms of all patient-reported outcome measures. The reduction in stiffness corresponded to the improvement in pain and PROMs, as shown by correlations which were insignificant for all measures.ConclusionsConservative therapy of masticatory muscle disorders involving manual therapy and stabilization occlusal splint is effective. It reduces the masseter stiffness as objectively shown in shear wave elastography and improves subjective PROMs scores, including numerical pain assessment and selected questionnaires. Shear wave elastography has the potential for broad application in clinical practice to monitor masticatory muscle disorders treatment effects due to its objectivity and non-invasive character. Further research is recommended on larger patient populations and longer follow-up.Trial registrationThe study was registered at clinicaltrials.gov (NCT03844854). First posted date: 19/02/2019.

Quality Assurance in Cataract and Lens Surgery with Special Consideration of Subjective Patient Reported Outcome Measures and Clinical Reported Outcome Measures.

Results of medical interventions must be documented and evaluated. In studies, this is done with clinical outcomes data (clinician/clinical reported outcome measure, CROM). In the past, less weight has been given to patient surveys with questionnaires (patient reported outcome measure, PROM). This retrospective study included 104 eyes from 53 patients. Of these, 35 patients had cataract surgery and 15 patients had a refractive lens exchange. The implanted lenses included 62 trifocal IOLs (Asphina trifiocal 839, Zeiss), 34 trifocal toric IOLs (Asphina trifocal toric 939, Zeiss) and 8 bifocal IOLs (Asphina 808, Zeiss) with the same IOL platform. Patients completed a modified questionnaire before surgery and one year after surgery. We made changes to the CatQuest-9SF questionnaire so as to also document side effects. The effort required by the patients to answer the questionnaire was a burden. Transcribing the data into electronic files so as they could be saved and analyzed was a lot of work for the staff. Among the patients, 88.7% were spectacle-independent in everyday life, and 77.5% for reading. 44.4% had a halo problem. 92% reported the operation as a success. 100% had a prediction error of ≤ ± 0.75 dpt. There is a high rate of patient satisfaction with the outcome of the intervention. New questionnaires are needed for new IOLs. The Catquest-9SF is from 2009. Accordingly, revisions and new validation is necessary. Beyond that, only automatic data transfer will reduce the amount of work involved in data input.

Evaluation of Optical and Radar Based Motion Capturing Technologies for Characterizing Hand Movement in Rheumatoid Arthritis-A Pilot Study.

In light of the state-of-the-art treatment options for patients with rheumatoid arthritis (RA), a detailed and early quantification and detection of impaired hand function is desirable to allow personalized treatment regiments and amend currently used subjective patient reported outcome measures. This is the motivation to apply and adapt modern measurement technologies to quantify, assess and analyze human hand movement using a marker-based optoelectronic measurement system (OMS), which has been widely used to measure human motion. We complement these recordings with data from markerless (Doppler radar) sensors and data from both sensor technologies are integrated with clinical outcomes of hand function. The technologies are leveraged to identify hand movement characteristics in RA affected patients in comparison to healthy control subjects, while performing functional tests, such as the Moberg-Picking-Up Test. The results presented discuss the experimental framework and present the limiting factors imposed by the use of marker-based measurements on hand function. The comparison of simple finger motion data, collected by the OMS, to data recorded by a simple continuous wave radar suggests that radar is a promising option for the objective assessment of hand function. Overall, the broad scope of integrating two measurement technologies with traditional clinical tests shows promising potential for developing new pathways in understanding of the role of functional outcomes for the RA pathology.

Correlation of Patient-Reported Outcomes With Physical Function After Total Ankle Arthroplasty.

Total ankle arthroplasty (TAA) is successful by both subjective patient-reported outcome measures (PROMs) and objective functional improvements of gait. Each is reproducible and valid, but they are entirely distinct methods. This study investigated the correlation between subjective and objective outcomes of TAA. Seventy patients underwent gait analysis preoperatively and 1 year after TAA. The 36-Item Short-Form Health Survey (SF-36) and visual analog score (VAS) for pain and American Orthopaedic Foot & Ankle Society (AOFAS) Ankle-Hindfoot Scores were recorded at each interval. A Student t test, a multivariate regression, and a Pearson correlation coefficient were used to measure the correlation between parameters of gait and PROMs. Patients had statistically significant improvements in gait velocity, total range of motion (ROM), maximum plantarflexion, ankle power, and SF-36 Physical, VAS, and AOFAS scores. The SF-36 Physical score had a moderate positive correlation with preoperative walking speed, step length, and ankle power and postoperative walking speed and ankle power. No correlation between VAS score and function was detected. The AOFAS score had a moderate positive correlation with postoperative walking speed, step length, and ankle power, and improvement in walking speed, cadence, and ankle power. Statistically significant correlations were found between numerous preoperative and postoperative comparisons of PROMs and the AOFAS score with the objective biomechanical outcomes of gait. Walking speed and ankle push-off power correlated most with patient perceptions of function and improvement, while pain and ROM did not. Subjective PROMs and objective biomechanical outcomes were complementary in the assessment of surgical outcomes and, combined, helped to address the dilemma of the confounding effect of other lower extremity pathologies on PROMs. Level III, comparative series.

Comparison Between Accelerated Partial Breast Irradiation and Whole Breast Irradiation: APBI IMRT Florence Retrospective Analysis of Subjective, Objective and Patient-reported Cosmetic Outcomes

Accelerated partial breast irradiation (APBI) represents a valid alternative to whole breast irradiation (WBI) in selected low risk patients with early stage breast cancer. The long-term analysis of the APBI-IMRT Florence randomized phase 3 trial showed no significant difference in terms of both local and distant disease control and survival outcomes. Acute/late toxicity and cosmesis evaluations were significantly in favor of the APBI arm. The aim of this analysis is to compare the agreement between objective and subjective patient-reported outcome measures (PROMs) of cosmesis assessment. From June 2019 to January 2020, 95 women previously enrolled in the APBI-IMRT Florence trial accepted to undergo photographic assessment. Late skin toxicity was assessed following the RTOG/EORTC late Radiation Morbidity Scoring questionnaire. Digital photographs were assessed (objective method) using the BCCT.core software v.31 (Breast Cancer Conservative Treatment. Cosmetic Results). Breast cosmetic outcomes scored both by physician and patient (subjective methods) were recorded using the Harvard Breast Cosmesis Grading Scale. At median follow up of 11 years (IQR 10.5-11.6 years), we evaluated 95 patients (51 APBI, 44 WBI). Late skin toxicity rates (any grade) were significantly in favor of the APBI group of patients (36.4% vs 6%; p = 0.0003). Also, cosmetic assessment was significantly in favor of the APBI group both evaluated by physician (excellent-good [EG] 98% vs 90%, p<0.0001; fair-poor [FP] 2% vs 10%, p = 0.0455) and patient (EG 86% vs 70%, p<0.0001; FP 14% vs 30%, p<0.0001). The BCCT.core cosmetic assessment showed significantly improved outcomes in the APBI group (EG 65% vs FP 35%) as compared to WBI group (EG 52% vs FP 48%; p = 0.0001). We observed a good agreement between BCCT.core objective evaluation and both patients (p = 0.19) and physicians PROMs (p = 0.17). Patients treated with APBI showed significant improved late toxicity and cosmetic outcomes. There is a significative agreement between patients/physician PROMs and BCCT.core. This score has proven to be a feasible tool in breast cancer clinical practice.

Prospective, longitudinal digital activity monitoring before and after treatment of low-risk oropharyngeal squamous cell carcinoma: A feasibility study.

6578 Background: Given the expected excellent prognosis of low-risk oropharyngeal squamous cell carcinoma (OPSCC), consideration of long-term toxicity and functional outcomes has become increasingly important. Activity monitors (e.g. FITBIT) are imperfect but have been shown to have reasonable validity in healthy adults. Here we aimed to test the feasibility of using medical grade longitudinal digital activity monitoring to better define objective functional outcomes after treatment of low-risk OPSCC. Methods: This prospective, observational parallel cohort study included patients with previously untreated stage I-III (AJCC 7) OPSCC eligible for standard of care single-modality treatment with either Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS). Objective Actigraph accelerometer data (Actigraph, Pensacola, FL) were collected continuously for 1 week at baseline, 3, 6 and 12 months after treatment along with subjective patient-reported outcome (PRO) measures. Results: Forty-four patients (34M, 10F) enrolled with median age 59 years (range: 42-78). Baseline, 3 and 6 month activity data were available for 40 patients (91%): 16 IMPT and 24 TORS. There was a significant decrease in mean percent of day performing moderate to vigorous physical activity (MVPA) (-0.78, 0.021) mean number of steps/minute (-1.1, p = 0.035), and mean kcals/day (-115.9, p &lt; 0.001) from baseline to 3 months after treatment for the overall cohort. A significant decrease in mean kcals/day (-82.2, p = 0.004) persisted for the overall cohort at 6 months with no significant difference between groups. Conclusions: Longitudinal digital activity monitoring is feasible before and after treatment of low-risk OPSCC. This approach may offer objective functional endpoints for future de-escalation trials. Similar short-term decreases in objective activity measurements were observed after IMPT and TORS. Long-term (12 month) activity data and correlations to subjective PRO measures will be available at the time of presentation. Clinical trial information: 02663583 .

Beyond intraocular pressure: Optimizing patient-reported outcomes in glaucoma.

Glaucoma, an irreversible blinding condition affecting 3-4% adults aged above 40 years worldwide, is set to increase with a rapidly aging global population. Raised intraocular pressure (IOP) is a major risk factor for glaucoma where the treatment paradigm is focused on managing IOP using medications, laser, or surgery regimens. However, notwithstanding IOP and other clinical parameters, patient-reported outcomes, including daily functioning, emotional well-being, symptoms, mobility, and social life, remain the foremost concerns for people being treated for glaucoma. These outcomes are measured using objective patient-centered outcome measures (PCOMs) and subjective patient-reported outcome measures (PROMs). Studies using PCOMs have shown that people with glaucoma have several mobility, navigational and coordination challenges; reading and face recognition deficits; and are slower in adapting to multiple real-world situations when compared to healthy controls. Similarly, studies have consistently demonstrated, using PROMs, that glaucoma substantially and negatively impacts on peoples' self-reported visual functioning, mobility, independence, emotional well-being, self-image, and confidence in healthcare, compared to healthy individuals, particularly in those with late-stage disease undergoing a heavy treatment regimen. The patient-centred effectiveness of current glaucoma treatment paradigms is equivocal due to a lack of well-designed randomized controlled trials; short post-treatment follow-up periods; an inappropriate selection or availability of PROMs; and/or an insensitivity of currently available PROMs to monitor changes especially in patients with newly diagnosed early-stage glaucoma. We provide a comprehensive, albeit non-systematic, critique of the psychometric properties, limitations, and recent advances of currently available glaucoma-specific PCOMs and PROMs. Finally, we propose that item banking and computerized adaptive testing methods can address the multiple limitations of paper-pencil PROMs; customize their administration; and have the potential to improve healthcare outcomes for people with glaucoma.

Reliability and Validity of the Persian Version of the Foot Function Index in Patients with Foot Disorders.

Foot function index (FFI) is a worthy subjective patient reported outcome measures (PROM) tool for evaluation of the outcomes of medical interventions on foot and ankle. This study was conducted to assess the validity of the Persian version of the foot function index (FFI). After translating the original FFI into Persian, back-translation was performed on the agreed Persian version and the final version was established. A total of 113 Persian-speaking patients with foot and ankle problems were enrolled in this study and were asked to fill in the FFI. The Cronbach's alpha for subsections of FFI and MOXFQ was above 0.8 and 0.7, respectively, while it was 0.95 and 0.93 for total FFI and MOXFQ, respectively. The ICC for all subsections of MOXFQ and FFI was above 0.7. The Pearson's correlation coefficient for all subsections of FFI and MOXFQ was significant (P<0.01). The Persian version of FFI is valid and reproducible in Persian speaking population. IV.

Aesthetics Assessment and Patient Reported Outcome of Nasolabial Aesthetics in 18-Year-Old Patients With Unilateral Cleft Lip.

Objective:To determine if there is a correlation between objective nasolabial aesthetics assessment using the Cleft Aesthetic Rating Scale (CARS) and patient satisfaction.Design:Retrospective analysis of a generic satisfaction questionnaire and independent assessment by three cleft surgeons of the nasolabial area of these patients on 2D frontal photographs, using the CARS.Setting:The Vrije Universiteit Medical Center and The Academic Center for Dentistry Amsterdam.Patients:Thirty-nine 18-year old patients with a repaired complete or incomplete unilateral cleft lip, with or without a cleft palate, and a completed satisfaction questionnaire. Exclusion criteria were an incomplete questionnaire; a history of facial trauma; and congenital syndromes affecting facial appearance.Main Outcome Measures:The correlation between surgeon evaluation (on a 5-point Likert scale) and patient satisfaction (not, moderately or very satisfied) on nasolabial appearance was assessed using Spearman rho (ρ).Results:There was a negligible correlation between surgeon evaluation and patient satisfaction on nose assessment (ρ = 0.20) and a moderate correlation on lip assessment (ρ = 0.32).Conclusions:Most literature supports this discrepancy between different objective aesthetics evaluation methods and subjective patient-reported outcome measures, suggesting there are factors playing a role in patient satisfaction that are impossible to objectify with assessment methods. Therefore, a strong emphasis should remain on clear communication between the physician and patient regarding their expectations, perception, and satisfaction of surgery results.

Associations between Health Assessment Questionnaire Disability Index and physical performance in rheumatoid arthritis and osteoarthritis.

To investigate whether the Health Assessment Questionnaire Disability Index (HAQ-DI) reflects objective measures of physical function in people with osteoarthritis (OA) and rheumatoid arthritis (RA). In total, 139 people, 71 with RA fulfilling the American College of Rheumatology (ACR) criteria (1987) and 68 with OA fulfilling ACR criteria for OA of the hip or knee, completed the HAQ-DI. Physical function was assessed using Timed Up and Go (TUG), 30 seconds Sit to Stand (STS), grip strength dynamometry and pedometer steps over 7days. The strongest association with HAQ-DI was with the TUG (R2 of 0.671 and 0.512 in RA and OA groups, respectively). HAQ-DI and STS showed a non-linear association in both groups with R2 of 0.380 in RA and 0.359 in OA. A strong association was found between HAQ-DI and grip strength in the OA group (R2 =0.681), whereas the RA group showed a moderate association (R2 =0.285). There was a strong association between the HAQ-DI and pedometer measures in RA (R2 =0.562), although this association was weak in OA (R2 =0.156). The HAQ-DI has a strong association with the TUG in both RA and OA. There was variable association between the HAQ-DI and other physical performance measures, as well as differences between the RA and OA cohorts. In order to form a full and accurate clinical picture, health professionals should perform both subjective patient-reported outcome measures and objective physical performance measures of disability.

Risk factors for nonroutine discharge in adult spinal deformity surgery

BACKGROUND CONTEXTSurgery for adult spinal deformity (ASD) is increasingly common. Although outcomes of ASD surgery have been studied extensively, to our knowledge, no data exist regarding factors predicting nonroutine discharge in this population. Nonroutine discharge is defined as discharge to a health care facility after surgery rather than to home. PURPOSETo determine which patient and surgical factors predict nonroutine discharge after ASD surgery. DESIGNThis is a retrospective study. PATIENTS SAMPLEWe conducted a retrospective single-center study of 303 patients who underwent arthrodesis of five or more spinal levels to treat ASD between 2009 and 2014. OUTCOME MEASURESPatients were stratified into two groups according to discharge disposition: home or nonroutine. METHODSObjective preoperative characteristics, intraoperative course, and postoperative recovery were analyzed to identify pre- and perioperative factors associated with nonroutine discharge. Univariate analysis was performed first. All factors with P values < .2 on univariate analysis were included in a logistic regression model. Additionally, to understand the relationship between subjective patient-reported outcome measures and nonroutine discharge, we compared the two groups with respect to mean Oswestry Disability Index and Scoliosis Research Society-22r domains using Student t-tests. RESULTSOn univariate analysis, objective measures that differed significantly (P < .05) between the two cohorts were age (≥65 years), osteoporosis, Charlson Comorbidity Index score of ≥2, prolonged hospital stay (>8 days), and blood transfusion. Given the above logistic regression inclusion criteria, we controlled for the performance, and type, of osteotomy (P = .055). On multivariate analysis, older age, osteoporosis, prolonged hospital stay, blood transfusion, and 3-column osteotomy were independently associated with nonroutine discharge. Subjective patient-reported outcome measures, including Oswestry Disability Index and Scoliosis Research Society-22r physical function and pain domain scores, were significantly worse in the nonroutine discharge cohort (P < .05). CONCLUSIONTo our knowledge, this is the first study to evaluate pre- and perioperative factors associated with nonroutine discharge after ASD surgery. Elderly patients who undergo complex surgery and receive blood transfusions are at particularly high risk of nonroutine discharge. Surgeons should consider these factors during surgical planning and preoperative patient counseling.

Application of validity theory and methodology to patient-reported outcome measures (PROMs): building an argument for validity

BackgroundData from subjective patient-reported outcome measures (PROMs) are now being used in the health sector to make or support decisions about individuals, groups and populations. Contemporary validity theorists define validity not as a statistical property of the test but as the extent to which empirical evidence supports the interpretation of test scores for an intended use. However, validity testing theory and methodology are rarely evident in the PROM validation literature. Application of this theory and methodology would provide structure for comprehensive validation planning to support improved PROM development and sound arguments for the validity of PROM score interpretation and use in each new context.ObjectiveThis paper proposes the application of contemporary validity theory and methodology to PROM validity testing.Illustrative exampleThe validity testing principles will be applied to a hypothetical case study with a focus on the interpretation and use of scores from a translated PROM that measures health literacy (the Health Literacy Questionnaire or HLQ).DiscussionAlthough robust psychometric properties of a PROM are a pre-condition to its use, a PROM’s validity lies in the sound argument that a network of empirical evidence supports the intended interpretation and use of PROM scores for decision making in a particular context. The health sector is yet to apply contemporary theory and methodology to PROM development and validation. The theoretical and methodological processes in this paper are offered as an advancement of the theory and practice of PROM validity testing in the health sector.

Non-invasive ventilation for the management of acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease.

Non-invasive ventilation for the management of acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease.