Subjective Patient-reported Outcomes Research Articles

Hybrid Cochlear Implant Outcomes and Improving Outcomes With Electric-Acoustic Stimulation.

Electric-acoustic stimulation (EAS) provides cochlear implant (CI) recipients with preserved low-frequency acoustic hearing in the implanted ear affording auditory cues not reliably transmitted by the CI including fundamental frequency, temporal fine structure, and interaural time differences (ITDs). A prospective US multicenter clinical trial was conducted examining the safety and effectiveness of a hybrid CI for delivering EAS. Fifty-two adults (mean age 59.9 yr) were enrolled in the study and followed up to 5 years postactivation. Testing included unaided and aided audiometric thresholds, speech perception (Consonant-Nucleus-Consonant [CNC] words in quiet and AzBio sentences +5 dB SNR), and patient-reported outcomes (Speech, Spatial, and Qualities of Hearing Scale). Functionally aidable hearing, defined as low-frequency pure-tone average (125-500 Hz) <80 dB HL, was maintained for 77% of patients through 1 year, with 66.7% maintaining through 5 years. Speech perception was significantly improved at all postoperative timepoints compared with preoperative performance with hearing aid(s), and patient-reported outcomes indicated significantly improved subjective speech understanding, spatial hearing, and sound quality. Participants with preserved acoustic hearing using EAS reported significantly higher subjective spatial hearing and sound quality than participants with electric-only hearing in the implanted ear. Patients with high-frequency hearing loss demonstrate significant long-term benefit with a hybrid CI including high rates of functional hearing preservation, significantly improved speech perception, and subjective patient-reported outcomes. EAS with binaural acoustic hearing affords benefit for subjective spatial hearing and sound quality beyond CI listening configurations using monaural acoustic hearing.

Comparison of Swallowing Measures to Patient-Reported Dysphagia Symptoms in Head and Neck Cancer Patients.

Head and neck cancer affects patient swallowing function. We set out to examine how objective measures of swallowing compare against subjective patient-reported outcomes in a cohort of head and neck cancer patients. Retrospective analysis of data collected from a large dysphagia HNC registry. Tertiary Academic Cancer Center. Between 2006 and 2019, objective measures of swallowing as scored on Modified Barium Swallow Study or Fiberoptic Endoscopic Evaluation of Swallowing and subjective measures using the SWAL-QOL were collected. Objective measures were scored by the Penetration-Aspiration Score (PAS); subjective measures were assessed by the Dysphagia Domain Score (DDS), collectively forming paired data points. Data on tumor site, T-stage, and treatment modality was collected and evaluated. A total of 253 paired data points were included in this study. A statistically significant relationship between PAS and DDS was observed across all patients (P < .05, chi sq). When stratified by tumor subsite, PAS and DDS relationships were strongest for oral cavity. When stratified by AJCC T-stage, T4 tumors had the strongest relationship between PAS and DDS. The relationship of PAS and DDS was less congruent the further removed from treatment completion. Objective and subjective measures of swallowing provide complementary evaluations of swallow function. The congruency of assessment varies by T stage and tumor subsite. Physicians and allied health professionals can use this information to better understand the value and limitation of objective and subjective swallowing assessments in evaluating head and neck cancer patients.

Return to play after UCL injury in gymnasts

ABSTRACT Background Injuries to the ulnar collateral ligament (UCL) are commonly reported in traditional overhead sports. Conversely, there is a lack of evidence outlining management and return to play (RTP) outcomes for gymnasts. This study aimed to evaluate RTP and patient reported outcomes (PROs) in gymnasts after operative and non-operative treatment of UCL injuries. Methods Gymnasts who presented with UCL injury and underwent operative and non-operative treatment were evaluated. Patient reported outcomes were collected via telephone: Conway-Jobe Scale, Kerlan-Jobe Orthopaedic Clinic Shoulder and Elbow (KJOC) Score, Mayo Elbow Performance (MEP) Score, quick DASH (qDASH) and Timmerman-Andrews (TA) Elbow Score. Results Nine patients met inclusion criteria and were available for follow-up. Five were initially treated operatively and 4 were initially treated non-operatively. The operative group initially consisted of 3 ulnar collateral ligament reconstructions (UCLR) and 2 UCL repairs with internal bracing. One patient crossed over to the operative group after failing non-operative treatment and underwent UCLR 4 months post injury. Overall, 66.7% and 100% of operatively and non-operatively treated gymnasts were able to return to play, respectively. At final follow-up, the operative groups’ mean KJOC, MEP, TA and qDASH scores were: 68.4 ± 7.7, 97.5 ± 2.7, 90.8 ± 10.7 and 1.9 ± 3.0, respectively. For the non-operative group, the mean scores were 67.4 ± 9.0, 71.7 ± 5.8, 71.7 ± 14.4 and 11.4 ± 9.9, respectively. Treatment satisfaction for the operative group was 81.7 ± 27.5 compared to 80.6 ± 34.5 in the non-operative group. Odds ratios indicated no differences between groups. Conclusion Both operative and non-operative interventions for UCL injuries in gymnasts can provide favorable outcomes with respect to return to play and subjective patient-reported outcomes. Further research is warranted to determine optimal treatment, especially regarding indications for operative vs. nonoperative treatment, of UCL injury based on injury severity and location in gymnasts. Level of Evidence Level III

Vectored Thermal Pulsation as a Treatment for Meibomian Gland Dysfunction: A Review Spanning 15 Years.

The LipiFlow Thermal Pulsation System received its first marketing clearance for the treatment of meibomian gland dysfunction (MGD) 13years ago. Since then, the evidence evaluating the effectiveness and safety of LipiFlow as a treatment for MGD has grown significantly. The objective of this comprehensive review was to summarize all clinical reports evaluating the effectiveness and safety of LipiFlow over the past 15years. The literature was systematically reviewed, and 55 unique articles had subjective (patient-reported outcomes) and objective (meibomian gland function, tear production, and ocular staining) outcomes for extraction. Data were collected from 2101patients and 3521 eyes treated with LipiFlow. Of these, effectiveness was evaluated in 2041patients and 3401 eyes, and safety was evaluated in 1448 patients and 2443 eyes. Taken together, the studies demonstrate that a single 12-min treatment with LipiFlow safely improves signs and symptoms of MGD and associated evaporative dry eye disease (DED), and the benefits persist up to 3years in some cases. The findings are corroborated by multiple meta-analyses and consensus guidelines. While some studies showed that daily eyelid hygiene, warm compress, and/or massage had a similar benefit to a single LipiFlow, these treatments were limited by inconvenience, discomfort, and non-compliance. The majority of studies evaluating safety reported no discomfort or pain associated with LipiFlow treatment, which supports the patient acceptability of LipiFlow therapy. All adverse events (AEs) related to LipiFlow were transient, non-vision-threatening, and did not require treatment. No studies reported serious AEs. The data obtained from 55 studies conducted globally overwhelmingly show that LipiFlow is effective and safe for the treatment of MGD and associated evaporative DED. The conclusions are supported by the diversity of the patient populations (geography, race, disease severity, and diagnosis), the large population treated with LipiFlow, the meta-analyses, and that this review analyzed all published clinical studies to date.

Paper 15: Survivorship of 157 Arthroscopic Meniscal Allograft Transplants Using Bone Fixation at Mean 7 Years and Prognostic Factors Analysis

Objectives: 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 &amp; Joint Preservation Society (ICRS) grade. The purpose of this study was 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. 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 (International Cartilage Regeneration &amp; Joint Preservation Society [ICRS] grade and Kellgren and Lawrence grade) were assessed preoperatively and at follow-up. Subjective patient-reported outcome measures (PROMs), Lysholm score, Knee Disability and Osteoarthritis Outcome Score (KOOS) including subscores, International Knee Documentation Committee (IKDC) score, and visual analog score (VAS) were collected preoperatively and at follow-up. Clinical failure was defined as revision surgery due to graft failure or conversion to total knee arthroplasty (TKA). Anatomic failure was considered a tear covering &gt;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 utilizing 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 (Table 1). 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 anatomic failure, and 13 patients (8.3%) suffered from 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 (HR 4.55; 95% CI 1.46-14.17; p=0.009) and anatomic failure (HR 3.05; 95% CI 1.34-6.92; p=0.008). 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=0.04) and anatomic failure (HR 3.04; 95% CI 1.31-7.11; p=0.01) (Table 2). There were no differences in outcomes between medial and lateral MAT. High-grade cartilage damage (defined as ICRS grades 3 and 4) preoperatively (HR 10.67; 95% CI 1.037-109.768; p=0.046), patients age over 25 (HR 5.44; 95% CI 0.120-246.070; p=0.384), and a body mass index &gt;30 (HR 2.24; 95% CI 0.748-6.705; p=0.149) were associated with subjective failure. Considering the entire study population, PROMs including KOOS and IKDC were significantly improved at final follow-up compared to preoperative scores across all measurements (p&lt;0.005). Conclusions: 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 osteochondral allograft transplantation are at higher risk of clinical and anatomic failure, but still report significantly improved PROMs. These results suggest MAT has a lasting beneficial effect both as in isolation and in complex cases with one or more concurrent procedures.

Soft-Tissue Augmentation Around Dental Implants by a New Laser-Aided Pouch Roll Technique: Volumetric and Clinical Evaluation After 1 Year.

The ultimate goal in implantology is to restore the whole tooth-gingival complex in a fashion that cannot be distinguished from the rest of the natural dentition. This study assesses the volumetric and clinical changes in vestibular gingival soft tissues, crucial for satisfactory engraftment and esthetic results, upon treatment with laser-aided pouch roll augmentation in second-stage surgery for dental implant uncovering. Twelve patients with mild ridge deficiencies in 16 edentulous sites, including distal elements, were enrolled and reevaluated for up to 1 year. Digital impressions, taken with an intraoral laser scanner and software, were analyzed before (day 0) and after (month 12) treatment. The digital STL files were superimposed to assess volumetric and linear dimensional variations in selected peri-implant regions of interest by 3D analysis software. Clinical periodontal parameters (probing depth [PD], bleeding on probing [BoP], plaque index [PI]) and subjective patient-reported outcomes were also evaluated. In all patients, the applied technique induced a substantial increase in the volume of the vestibular peri-implant gingiva at 12-month follow-up (range, 24%-69%, mean 40.4%) with respect to day 0. The gingival mucosa appeared normal at both inspection and evaluation of the periodontal parameters (PD 2.7 ± 1 mm; BoP 0.11 ± 0.2 seconds; PI 0.19 ± 0). Patients' satisfaction with perceived pain/discomfort and esthetic outcome was high. These findings indicate that laser-aided pouch roll flap is a safe, patient-liked procedure whose long-term effectiveness has been objectively demonstrated by volumetric and clinical assessment.

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.

Postparetic Synkinesis: Objective and Subjective Comparisons of Depressor Anguli Oris Myectomies versus Depressor Anguli Oris and Buccinator Myectomies.

Muscles affected by postparetic synkinesis have imbalanced tonicity that limit perioral mimetic movement and inhibit the ability to smile. The depressor anguli oris (DAO) muscle has been a common myectomy target for the treatment of perioral synkinesis. While addition of buccinator myectomies to DAO myectomies has risen, no studies have analyzed the effects of buccinator myectomies. The goal of this study was to evaluate and compare the effects of a DAO myectomy with and without concomitant buccinator myectomy through objective facial metrics and subjective patient-reported outcomes. This study is a retrospective review of patients with postparetic synkinesis who underwent DAO myectomy (DAO myectomy group) or DAO myectomy with buccinator myectomy (DAO + Buccinator myectomies group). Outcomes included postoperative differences in objective smile measures (smile angle, excursion, and dental show) using validated software and patient-reported outcomes using the Facial Disability Index (FDI) questionnaire and a myectomy-specific questionnaire. After chart review, 18 patients were included in the DAO myectomy group and 19 in the DAO + Buccinator myectomies group. There were no significant postoperative differences between the groups in (1) smile excursion, angle, or dental show at resting, closed smile, or open smile (p > 0.05), (2) FDI physical and social scores, p = 0.198 and 0.932, respectively, or (3) myectomy-specific questionnaire responses (p > 0.05). The addition of a buccinator myectomy to a DAO myectomy does not provide significant clinical benefit when compared with an isolated DAO myectomy, based on objective measures and subjective patient-reported 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.

Minimum 10-Year Outcomes of Matrix-Induced Autologous Chondrocyte Implantation in the Knee: A Systematic Review.

Matrix-induced autologous chondrocyte implantation (MACI) is an established cell-based therapy for the treatment of chondral defects of the knee. As long-term outcomes are now being reported in the literature, it is important to systematically review available evidence to better inform clinical practice. To report (1) subjective patient-reported outcomes (PROs) and (2) the rate of graft failure, reoperation, and progression to total knee arthroplasty (TKA) after undergoing MACI of the knee at a minimum 10-year follow-up. Systematic review; Level of evidence, 4. A comprehensive search of Ovid MEDLINE and Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Daily; Ovid Embase; Ovid Cochrane Central Register of Controlled Trials; Ovid Cochrane Database of Systematic Reviews; and Scopus from 2008 to September 15, 2022, was conducted in the English language. Study eligibility criteria included (1) full-text articles in the English language, (2) patients undergoing a MACI within the knee, (3) clinical outcomes reported, and (4) a minimum 10-year follow-up. In total, 168 patients (99 male, 69 female; mean age, 37 years [range, 15-63 years]; mean body mass index, 26.2 [range, 18.6-39.4]) representing 188 treated chondral defects at a minimum 10-year follow-up after MACI were included in this review. Significant and durable long-term improvements were observed across multiple PRO measures. Follow-up magnetic resonance imaging (MRI), when performed, also demonstrated satisfactory defect fill and an intact graft in the majority of patients. The all-cause reoperation rate was 9.0%, with an overall 7.4% rate of progression to TKA at 10 to 17 years of follow-up. At a minimum 10-year follow-up, patients undergoing MACI for knee chondral defects demonstrated significant and durable improvements in PROs, satisfactory defect fill on MRI-based assessment, and low rates of reoperation and TKA. These data support the use of MACI as a long-term treatment of focal cartilage defects of the knee.

Treatment of osteochondral injuries of the humeral head using fresh osteochondral allograft transplantation

BackgroundLarge osteochondral lesions of the humeral head can result from locked posterior dislocations, avascular necrosis, and osteochondritis dissecans. Fresh osteochondral allograft (OCA) transplantation is a treatment option for young patients with focal osteochondral defects of the humeral head. The purpose of this case series was to assess graft survivorship, subjective patient-reported outcomes (PROMs), and satisfaction among seven patients who underwent OCA transplantation of the humeral head. MethodsWe identified seven patients who underwent humeral head OCA transplantation between 2008 and 2017. A custom questionnaire for patient reported outcome measures including ASES, QuickDASH, Likert satisfaction, and reoperations was mailed to each patient. Clinical failure was defined as further surgery that involved removal of the allograft. ResultsMedian follow-up duration was 10 years (range, 4.6 to 13.5 years) with a median age of 21.6 years (range, 18.5 to 43.5 years). Most patients (86%) reported improved function and reduced pain. At final follow-up, 71% of patients reported ongoing problems with their shoulder including pain, stiffness, clicking/grinding, limited range of motion, and instability. Return to recreational activities was high at 86% but 43% expressed limitations with activity due to their shoulder. Overall satisfaction was high at 71% with mean ASES and QuickDASH scores at 62.4 and 29.2 respectively. Reoperation after OCA occurred in one patient (14%). ConclusionsAmong this case series of seven patients who underwent OCA transplantation of the humeral head, patient satisfaction was high at 10 year follow-up and most returned to recreational activity although most also had persistent shoulder symptoms.

Clinical outcomes and patient-reported outcomes after oncoplastic breast surgery in breast cancer patients: A matched cohort study.

Surgery is the recommended treatment for breast cancer, the most common cancer in women in Taiwan and the leading cause of cancer-related deaths. Although breast-conserving surgery (BCS) has good prognosis, in some cases, BCS may cause more significant deformities and interfere with the patient's psychosocial well-being. Oncoplastic breast surgery (OBS) is the treatment option in these cases. This study aimed to determine the outcomes of OBS and BCS regardless of clinical and patient-reported esthetic outcomes. Between 2015 and 2020, 50 patients who underwent OBS at our hospital after complete treatment were enrolled. With 1:2 matched ratios, 100 patients were enrolled in the BCS control group. Clinical outcomes were analyzed. The BREAST-Q questionnaire was then assessed 6 months after the completion of treatment for subjective patient-reported outcomes. Due to the matching process, no difference was noted between the two groups in terms of demographic data such as age, comorbidities, or tumor characteristics. There were no significant differences in the local recurrence rate, disease-free survival, overall survival, positive margin rate, rewide excision rate, conversion to mastectomy rate, or complication rate (major or minor) between both groups. However, the OBS group showed higher satisfaction with breasts in the BREAST-Q questionnaire ( p < 0.001). The mean follow-up time was 38.77 ± 14.70 months in the BCS group and 29.59 ± 14.06 months in the OBS group. OBS seems to be a safe and feasible surgery in breast cancer patients because clinical outcomes are compatible with BCS. Moreover, the OBS group had better patient-reported outcomes in terms of satisfaction.

Minimally invasive ureteroplasty with lingual mucosal graft for complex ureteral stricture: analysis of surgical and patient-reported outcomes.

To evaluate objective treatment efficacy and safety, and subjective patient-reported outcomes in patients with complex ureteral strictures (US) undergoing minimally invasive lingual mucosal graft ureteroplasty (LMGU). We prospectively enrolled patients underwent robotic or laparoscopic LMGU between May 2020 and July 2022. Clinical success was defined as symptom-free and no radiographic evidence of re-obstruction. Patient-reported outcomes, including health-related quality of life (HRQoL), mental health status and oral health-related quality of life (OHRQoL), were longitudinally evaluated before surgery, 6 and 12 months postoperatively. Overall, 41 consecutive patients were included. All procedures were performed successfully with 32 patients in robotic approach and 9 in laparoscopic. Forty (97.56%) patients achieved clinical success during the median follow-up of 29 (range 15-41) months. Although patients with complex US experienced poor baseline HRQoL, there was a remarkable improvement following LMGU. Specifically, the 6-month and 12-month postoperative scores were significantly improved compared to the baseline (p < 0.05) in most domains. Twenty-eight (68.3%) and 31 (75.6%) patients had anxiety and depression symptoms before surgery, respectively. However, no significant decrease in the incidence of these symptoms was observed postoperatively. Moreover, there was no significant deterioration of OHRQoL at 6 months and 12 months postoperatively when compared to the baseline. LMGU is a safe and efficient procedure for complex ureteral reconstruction that significantly improves patient-reported HRQoL without compromising OHRQoL. Assessing patients' quality of life enables us to monitor postoperative recovery and progress, which should be considered as one of the criteria for surgical success.

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.

Objective wearable measures and subjective questionnaires for predicting response to neurostimulation in people with chronic pain

BackgroundNeurostimulation is an effective therapy for treating and management of refractory chronic pain. However, the complex nature of pain and infrequent in-clinic visits, determining subject’s long-term response to the therapy remains difficult. Frequent measurement of pain in this population can help with early diagnosis, disease progression monitoring, and evaluating long-term therapeutic efficacy. This paper compares the utilization of the common subjective patient-reported outcomes with objective measures captured through a wearable device for predicting the response to neurostimulation therapy.MethodData is from the ongoing international prospective post-market REALITY clinical study, which collects long-term patient-reported outcomes from 557 subjects implanted by Spinal Cord Stimulator (SCS) or Dorsal Root Ganglia (DRG) neurostimulators. The REALITY sub-study was designed for collecting additional wearables data on a subset of 20 participants implanted with SCS devices for up to six months post implantation. We first implemented a combination of dimensionality reduction algorithms and correlation analyses to explore the mathematical relationships between objective wearable data and subjective patient-reported outcomes. We then developed machine learning models to predict therapy outcome based on the subject’s response to the numerical rating scale (NRS) or patient global impression of change (PGIC).ResultsPrincipal component analysis showed that psychological aspects of pain were associated with heart rate variability, while movement-related measures were strongly associated with patient-reported outcomes related to physical function and social role participation. Our machine learning models using objective wearable data predicted PGIC and NRS outcomes with high accuracy without subjective data. The prediction accuracy was higher for PGIC compared with the NRS using subjective-only measures primarily driven by the patient satisfaction feature. Similarly, the PGIC questions reflect an overall change since the study onset and could be a better predictor of long-term neurostimulation therapy outcome.ConclusionsThe significance of this study is to introduce a novel use of wearable data collected from a subset of patients to capture multi-dimensional aspects of pain and compare the prediction power with the subjective data from a larger data set. The discovery of pain digital biomarkers could result in a better understanding of the patient’s response to therapy and their general well-being.

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.

Not All Patients Need Supervised Physical Therapy After Primary Total Knee Arthroplasty: A Systematic Review and Meta-Analysis.

Although postoperative physical therapy (PT) has long been considered essential to successful total knee arthroplasty (TKA) recovery, recent literature has suggested that unsupervised home exercise regimens may offer similar benefits to formal supervised sessions. We aimed to compare objectively measured physical function and subjective patient-reported outcomes (PROs) between primary TKA patients who received formal supervised physical therapy sessions and those who received unsupervised home exercise regimens after discharge. Six electronic databases were queried to identify randomized controlled trials comparing supervised physical therapy to unsupervised home exercise regimens in primary TKA patients after discharge. Outcomes of interest included change from baseline in objective measures (knee flexion range of motion (ROM), lower extremity strength, and aerobic capacity) and PROs (physical function and quality of life scores). These outcomes were subdivided into short-term (<6 months from surgery; closest data point to three months is used if multiple measurements were made in this time period) and long-term (≥6 months from surgery; closest data point to 12 months is used if multiple measurements were made in this time period) assessments. A total of 1,884 cases performed in 11 studies were included in this review. There were no significant differences between cohorts with regardto short-term knee flexion ROM (p = 0.7), lower extremity strength (p = 0.6), or patient-reported quality of life (p = 0.5), as well as long-term knee flexion ROM (p = 0.7), patient-reported quality of life (p = 0.2), or patient-reported physical outcome scores (p = 0.3). A small difference in short-term patient-reported physical outcomes was observed in favor of the supervised cohort (standardized mean difference(SMD): 0.3 (95% confidence interval (CI): 0.01, 0.6); I2= 82%; p = 0.04). Formal supervised physical therapy regimens do not confer clinically significant benefits over unsupervised home exercise regimens following primary TKA. The routine use of supervised physical therapy after discharge may not be warranted. Further study is needed to determine the subset of patients that may benefit from supervised care.

Validation of the Foot and Ankle Outcome Score (FAOS) for Ankle Osteochondral Lesions

Category: Sports; Ankle Introduction/Purpose: Subjective patient-reported outcome scores are routinely used to evaluate the efficacy of surgical interventions however to date none have been validated for ankle osteochondral lesions (OCL's). The foot and ankle outcome score (FAOS) is a 42 item subjective questionnaire consisting of 5 domains: pain, symptoms, function in daily activities, function in sports, and quality of life. It has been recently validated for flatfoot deformity and hallux valgus correction. The aim of this study was to validate the FAOS for ankle OCL's. Methods: Patients diagnosed with ankle OCL's from 2008 to 2013 were identified through the hospital foot and ankle registry. A retrospective analysis was performed to determine construct validity, where the FAOS subscales were compared with corresponding short form-12 (SF-12) subscales. Correlation was deemed moderate if the Spearman's correlation coefficient was .4 to .7. Preoperative and postoperative scores of 54 patients with OCL's were compared to determine responsiveness. Content validity was prospectively assessed in 20 patients by a separate questionnaire where patients rated the relevance of each FAOS question to their ankle OCL. A score of 2 or more was considered acceptable. Both retrospective analysis and prospective evaluation of 44 patients were used to assess test-retest reliability, which was measured using intraclass correlation coefficients (ICC's). Results: All of the FAOS subscales demonstrated moderate correlation with the physical health component of the SF-12. The FAOS symptoms subscale showed the least correlation, demonstrating the foot-specific nature of the questionnaire. Mental health related domains demonstrated poor correlation. All five FAOS domains are significantly responsive to change in postoperative patients (p&lt;0.01). All domains have acceptable content validity overall, with quality of life (QoL) and function in sports the highest. Test-retest reliability was very good for all domains with ICC's above 0.8. Conclusion: Patient-based assessments have become increasingly important in evaluating treatment effectiveness. This study has shown that the FAOS has very good construct and content validity, reliability, and responsiveness in patients with ankle OCL's. We support its use and consider it a useful patient-based instrument for the assessment of surgical intervention