Patient-reported Outcome Metrics Research Articles

471 Using the QOD to Identify Minimum Clinically Important Differences for Patients With Cervical Spondylotic Myelopathy

INTRODUCTION: Minimum clinically important differences (MCID) for quality-adjusted life years (QALYs) and arm pain patient-reported outcome metrics (PROMs) in cervical spondylotic myelopathy (CSM) have yet to be determined, while data for myelopathy severity, impairment, and neck pain remain limited by small series and low rates of follow-up. METHODS: The CSM database of the QOD Study Group was utilized for this analysis. Patients were prospectively enrolled and followed for 24 months, with a follow-up rate of 85.2%. The MCIDs were computed for five standardized instruments: Neck Disability Index (NDI), five-dimension Euro-QoL (EQ-5D) in QALYs, neck and arm pain numeric rating scale (NRS), and modified Japanese Orthopedic Association score (mJOA) at both 3 and 24-month follow-up. Seven previously validated measures of MCID were compared using the area-under-the-curve (AUC). The North American Spine Society (NASS) satisfaction scale was the anchor, with scores of 1-2 meeting criteria for satisfaction. RESULTS: A total of 1,141 patients underwent surgery for CSM. Improvement of =30% from baseline was the optimal MCID across time points for NDI and neck/arm NRS. At 24 months, 30% improvement for these three instruments resulted in AUCs of 0.73, 0.71, and 0.67, respectively. Numeric cut-offs (0.065 at 3 months and 0.149 at 24 months) were the superior MCIDs for EQ-5D-derived QALYs. For mJOA, a severity-adjusted MCID outperformed the other methods, yielding an AUC of 0.67 at 24 months. CONCLUSIONS: We used the QOD dataset to define previously unknown MCIDs for several outcome measures. A =30% improvement from baseline was a consistent, high-performing MCID in NDI and arm/neck NRS. However, an absolute numeric cut-off (0.149) was the superior MCID for EQ-5D QALYs. mJOA exhibited the lowest predictive capacity for patient satisfaction.

Patient-reported quality of life and acceptance of the extravascular implantable cardioverter-defibrillator: Results from pivotal study.

The pivotal study of the extravascular implantable cardioverter-defibrillator (EV ICD) recently demonstrated primary efficacy and safety endpoints comparable to previous ICD systems. Patient experience with this novel device has not been reported. The current study examined the standardized patient-reported outcome (PRO) metrics of quality of life (QOL) and patient acceptance of the device. The EV ICD Pivotal Study was a prospective, single-arm, nonrandomized, global, premarket approval trial. Patients completed the 12-Item Short Form Survey (SF-12) QOL surveys at baseline and at 6 months following implant. Additionally, patients completed the Florida Patient Acceptance Survey (FPAS) QOL survey at 6 months. From baseline to 6 months, patients within the EV ICD Pivotal Study (n = 247) reported statistically significant SF-12 improvements in physical QOL (45.4 ± 9.4 vs. 46.8 ± 9.1 respectively, p = .020) and no changes in mental QOL (49.3 ± 10.4 vs. 50.5 ± 9.7, p = .061). No differences were noted by sex, atrial fibrillation, or the experience of ICD shock. EV ICD patients reported better total FPAS patient acceptance of their ICD than TV-ICD or S-ICD patients using historical norms comparisons (80.4 ± 15.7 vs. 70.2 ± 17.8, p < .0001 for S-ICD and 73.0 ± 17.4, p = .004 for TV-ICD). The initial PROs for EV ICD patients indicated that patients had improvements in physical QOL from baseline to 6-month follow-up and markedly better overall acceptance of their ICD compared to a previous study with S-ICD and TV-ICD data. These initial results suggest that the EV ICD is evaluated positively by patients.

Providing meaningful interpretation of performance outcome measures by co-calibration with patient-reported outcomes through the Rasch model: illustration with multiple sclerosis measures

ABSTRACT Performance outcome (PerfO) measures are based on tasks performed by patients in a controlled environment, making their meaningful interpretation challenging to establish. Co-calibrating PerfO and patient-reported outcome (PRO) measures of the same target concept allow for interpretation of the PerfO with the item content of the PRO. The Rasch model applied to the discretized PerfO measure together with the PRO items allows expressing parameters related to the PerfO measure in the PRO metric for it to be linked to the PRO responses. We applied this approach to two PerfO measures used in multiple sclerosis (MS) for walking and manual ability: the Timed 25-Foot Walk (T25FW) and the 9-Hole Peg Test (9HPT). To determine meaningful interpretation of these two PerfO measures, they were co-calibrated with two PRO measures of closely related concepts, the MS walking scale − 12 items (MSWS-12) and the ABILHAND, using the data of 2,043 subjects from five global clinical trials in MS. The probabilistic relationships between the PerfO measures and the PRO metrics were used to express the response pattern to the PRO items as a function of the unit of the PerfOs. This example illustrates the promises of the co-calibration approach for the interpretation of PerfO measures but also highlights the challenges associated with it, mostly related to the quality of the PRO metric in terms of coverage of the targeted concept. Co-calibration with PRO measures could also be an adequate solution for interpretation of digital sensor measures whose meaningfulness is also often questioned.

Long-term outcomes after osteochondral allograft transplantation to the humeral head.

Long-term outcomes of osteochondral allograft (OCA) transplantation to the humeral head have been sparsely reported in the literature. To evaluate outcomes and survivorship of OCA transplantation to the humeral head in patients with osteochondral defects at a minimum of 10years of follow-up. A registry of patients who underwent humeral head OCA transplantation between 2004 and 2012 was reviewed. Patients completed pre and postoperative surveys including the American Shoulder and Elbow Surgeons score, Simple Shoulder Test, Short Form 12 (SF-12), and the visual analog scale. Failure was defined by conversion to shoulder arthroplasty. Fifteen of 21 (71%) patients with a minimum of ten year of follow-up (mean: 14.2±2.40) were identified. Mean patient age was 26.1±8.8years at the time of transplantation and eight (53%) patients were male. Surgery was performed on the dominant shoulder in 11 of the 15 (73%) cases. The use of local anesthetic delivered via an intra-articular pain pump was the most often reported underlying etiology of chondral injury (n=9; 60%). Eight (53%) patients were treated with an allograft plug, while seven (47%) patients were treated with a mushroom cap allograft. At final follow-up, mean American Shoulder and Elbow Surgeons (49.9 to 81.1; P=.048) and Simple Shoulder Test (43.1 to 83.3; P=.010) significantly improved compared to baseline. Changes in mean SF-12 physical (41.4 to 48.1; P=.354), SF-12 mental (57.5 to 51.8; P=.354), and visual analog scale (4.0 to 2.8; P=.618) did not reach statistical significance. Eight (53%) patients required conversion to shoulder arthroplasty at an average of 4.8±4.7years (range: 0.6-13.2). Kaplan-Meier graft survival probabilities were 60% at 10years and 41% at 15years. OCA transplantation to the humeral head can result in acceptable long-term function for patients with osteochondral defects. While patient-reported outcomes metrics were generally improved compared to baseline, OCA graft survival probabilities diminished with time. The findings from this study can be used to counsel future patients with significant glenohumeral cartilage injuries and set expectations about the potential for further surgery.

Intermediate Term Clinical Outcomes in Total Ankle Arthroplasty: The CU Total Ankle Registry

Category: Ankle Arthritis; Ankle Introduction/Purpose: Total ankle arthroplasty (TAA) is a common procedure to treat end stage ankle osteoarthritis. Despite recent increase in popularity, there is limited literature assessing clinical and patient-reported outcomes (PROs) in TAA procedures using 5 current generation implants. These measures are an important tool for physicians to better assess patient performance in daily activities. The purpose of this study is to characterize both PROs and clinical outcomes in primary and revision TAA surgeries using current generation prostheses performed by non-design surgeons at a single institution. Methods: Our institution maintains a prospective outcomes registry for patients undergoing TAA at our institution. Patient demographics, relevant case information, PROs and complications are collected. Collected PROs include PROMIS Physical Function (PF), Pain Interference (PI), Depression, Global Physical Health (GPH), Global Mental Health (GMH), and Foot and Ankle SANE. Records are categorized as a primary TAA, or revision involving either a polyethylene only exchange or complete hardware removal and replacement. Differences between groups were determined non-parametrically using Mann-Whitney U tests. In all statistical tests, a p value of less than 0.05 was considered significant. Results: A total of 259 patients were included for analysis; 223 primary and 36 partial or full revision. Average length of stay was 1.6 ± 1 days. There were 18 reoperations (6.95%), with no implant failures within 1 year. Five patients underwent implant revision at an average of 2.5 years. Of these, one was related to delayed infection at year 3, two due to hardware failure in year 2, and 2 polyethylene exchanges in years 2 and 5. All physical health PRO measures showed significant improvements post-operatively (p &lt; 0.0001). Patients reported significant reductions in pain following TAA at 3-months (Figure 1a), and significant improvement of physical function after 6-months (Figure 1b). There were no significant changes in Depression or GMH (Figure 1d). Conclusion: Total ankle arthroplasty is a safe and effective procedure for end-stage ankle arthritis. Patients experience improvement in all physical health PRO metrics at all post-operative time points after 3 months. Complication and early failure rates are lower than that reported in the literature. Long term outcomes and implant longevity will be tracked using the CU Total Ankle Registry. Total ankle arthroplasty improves quality of life in patients suffering from ankle osteoarthritis. Further follow-up and patient enrollment in the CU Total Ankle Registry will help us to identify risk factors for complications and define implant lifespan.

Predictors of Poor Treatment Experience in Cervical Cancer Patients Receiving Definitive Chemoradiation and Brachytherapy Boost: A Prospective Study

Cervical cancer patients experience high overall symptom burden. Here, we analyzed patient reported outcomes (PROs) to identify disease, treatment, or patient-related characteristics that can predict poor treatment experience. Cervical cancer patients treated with definitive chemoradiation (CRT) at a single institution enrolled on a prospective trial evaluating PROs between 2021-2023 were included. Patients received PRO questionnaires at baseline (BL) and 2-7 days after final brachytherapy implant (post-BT). Data was collected using the EORTC-QLQ-C30, which is a validated metric scored on a 4-point Likert scale (1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much). Poor treatment experience was defined as low physical function [score >2], significant overall symptom burden [> population mean], or substantial nausea/vomiting (N/V), diarrhea, pain, or fatigue [score >2] after BT. Potential predictors included age, menopause status, stage, radiation field size, BT modality (PDR vs HDR), marital status, high baseline financial toxicity [score >2], depression [score >2], worse social function [score >2] and poor emotional function [score >2]. Logistic regression modeling was performed and p<0.05 were considered significant. A total of 36 patients completed BL and post-BT PRO metrics. Median age was 42 (range, 18-85), 22% (n = 8) of patients had localized disease, 75% (n = 27) had regional disease, and 3% (n = 1) had distant disease. Low BL social function was associated with high symptom burden after BT (HR 12.5, 95% CI 2.3-68.2, p = 0.004), significant N/V (HR 19.0, 95% CI 1.9-191.0, p = 0.012), high rates of fatigue (HR 9.29, 95% CI 1.6-54.8, p = 0.014), and overall poor physical function after treatment (HR 5.67, 95% CI 1.1-30.1, p = 0.042). High BL financial toxicity was predictive of elevated symptom burden after BT (HR 12.0, 95% CI 2.2-66.0, p = 0.004) and substantial fatigue (HR 7.33, 95% CI 1.5-36.7, p = 0.015). Significant depression at BL was also associated with high rates of N/V (HR 9.78, 95% CI 1.4-66.9, p = 0.02). Patient age, menopausal status, disease stage, radiation field size, BT modality, and marital status were not significantly predictive for symptom burden or physical function after treatment. Patients with poor baseline social function, high financial toxicity, and depression are at risk for increased symptom burden. Screening for these factors may provide an opportunity to intervene early and improve patient treatment experience.

Patient Reported Outcomes for Women Undergoing Definitive Chemoradiation for Gynecologic Cancer: A Prospective Clinical Trial

Patients with gynecologic malignancies have high psychosocial and symptom burden. We report data from a prospective trial evaluating patient-reported outcome (PRO) metrics in women undergoing definitive chemoradiation with brachytherapy (BT). A single-institution prospective trial evaluating outcomes of gynecologic cancer patients undergoing BT. Questionnaires to assess PROs at baseline, post-BT, and 60-day follow-up were collected, using European Organization for Research and Treatment of Cancer-Quality of Life Question-Core 30 and European Organization for Research and Treatment of Cancer-Quality of Life Question-Cervical Cancer Module validated metrics. Higher scores for functional scales/global health and lower scores for symptom items are favorable. European Organization for Research and Treatment of Cancer-Quality of Life Question-Core 30 mean scores were compared with a reference population. When comparing the study population between time points, medians, interquartile range, and nonparametric testing were used. Thirty-three patients were enrolled, and 29 (88%) completed baseline PRO metrics. Mean global health score was worse than the reference population of women with any cancer diagnosis at baseline (41 vs 59, P < .001) and decreased further at follow-up (42 vs 33, P=.005). Compared with the cervical cancer reference, our patients had significantly worse social function (62 vs 83, P=.03), financial toxicity (49 vs 10, P < .001), fatigue (49 vs 34, P=.04), nausea/vomiting (26 vs 9, P=.001), and appetite loss (36 vs 16, P=.004).The majority of patients described depression (53%), feeling less attractive (64%), life interference (66%), and/or worry (69%). At baseline, higher global health scores were associated with improved physical functioning (R20.58, P < .001), social functioning (R20.56, P < .001), and body image (R20.40, P < .001); lower scores with more symptom burden (R20.71, P < .001), financial toxicity (R20.50, P < .001), and/or sexual worry (R20.25, P=.001). Patients with cervical cancer have significant symptom burden and psychosocial toxicity, contributing to decreased quality of life. These data highlight the need for improved support throughout treatment for this high-risk population.

Does humeral fixation technique affect long-term outcomes of total shoulder arthroplasty?

For anatomic total arthroscopic repair, cementless humeral fixation has recently gained popularity. However, few studies have compared clinical, radiographic, and patient-reported outcomes between cemented and press-fit humeral fixation, and none have performed follow-up for longer than 5 years. In this study, we compared long-term postoperative outcomes in patients receiving a cemented versus press-fit humeral stem anatomic arthroscopic repair. This study retrospectively analyzed 169 shoulders that required primary anatomic total shoulder arthroplasty (aTSA). Shoulders were stratified by humeral stem fixation technique: cementation or press-fit. Data were collected pre- and postoperatively. Primary outcome measures included range of motion, patient reported outcomes, and radiographic measures. One hundred thirty-eight cemented humeral stems and 31 press-fit stems were included. Significant improvements in range of motion were seen in all aTSA patients with no significant differences between final cemented and press-fit stems (forward elevation: P=0.12, external rotation: P=0.60, and internal rotation: P=0.77). Patient reported outcome metrics also exhibited sustained improvement through final follow-up. However, at final follow-up, the press-fit stem cohort had significantly better overall scores when compared to the cemented cohort (visual analog score: P=0.04, American Shoulder and Elbow Surgeon Score: P<0.01, Simple Shoulder Test score: P=0.03). Humeral radiolucency was noted in two cemented implants and one press-fit implant. No significant differences in implant survival were observed between the two cohorts (P=0.75). In this series, we found that irrespective of humeral fixation technique, aTSA significantly improves shoulder function. However, within this cohort, press-fit stems provided significantly better outcomes than cemented stems in terms of patient reported outcome scores. Level of evidence: III.

Short-Term Outcomes of Concomitant Patellofemoral Arthroplasty and Medial Patellofemoral Ligament Reconstruction to Treat Concurrent Patellofemoral Arthritis and Patellar Instability.

The purpose of this study was to evaluate the efficacy of combined patellofemoral arthroplasty (PFA) and medial patellofemoral ligament (MPFL) reconstruction in patients with patellofemoral arthritis in the setting of concomitant patellar instability. Patients who underwent single-stage, combined PFA and MPFL reconstruction by a single surgeon at a tertiary-care orthopaedic center between 2016 and 2021 were identified. Postoperative radiographic and clinical outcomes at a minimum of 6 months were recorded using patient-reported outcome measures, including International Knee Documentation Committee (IKDC), Kujala, and VR-12. Early complications and rates of recurrent instability were also recorded. Of the 16 patients who met inclusion and exclusion criteria, 13 patients were available for final follow-up (81%; 51.7 ± 7.2 years, 11 females, 2 males) with a mean clinical follow-up of 1.3 ± 0.5 years (range: 0.5-2.3 years). Patients experienced significant improvements in patellar tilt and multiple patient-reported outcome metrics postoperatively, including IKDC, Kujala, VR-12 Mental Health, and VR-12 Physical Health. At the time of the most recent follow-up, no patient had experienced a postoperative dislocation or subluxation event. The findings suggest that concurrent PFA and MPFL reconstruction are associated with significant improvements in multiple patient-reported outcomes. Further studies are needed to evaluate the duration of clinical benefits achieved with this combined intervention.

In-office needle arthroscopy is a cost-effective alternative for operating room diversion in medial meniscectomy: a financial analysis

BackgroundIn-office needle arthroscopy (IONA) has been described as a diagnostic alternative to magnetic resonance imaging (MRI) for intra-articular pathology. However, few studies have analyzed its impact on cost and wait times when used as a therapeutic intervention. The purpose of this study was to investigate the impact on cost and wait times associated with offering IONA for partial medial meniscectomy as an alternative to traditional operating room (OR) arthroscopy for patients with irreparable medial meniscus tears on MRI.MethodsTwo models were created comparing the existing care pathway (current state) to a proposed future state utilizing IONA. Data sources were accounting data from an academically affiliated hospital in Canada and supplemented with literature values. A Monte Carlo simulation combined with DuPont analysis running 10,000 simulations was conducted to calculate the revenue, expenses, profits, and effect on surgical waitlists (i.e., throughput) between the states. Sensitivity analyses examined the influence of patient preference and revision rates on profit and throughput. Two-sample Student’s t test was performed (p < .05).ResultsAn average of 198 (standard deviation (SD) 31) patients underwent arthroscopic meniscectomy or repair each year from 2016 to 2020. The IONA revision rate was calculated as 20.3%. Compared to the current state, annual expenses in the IONA pathway were significantly reduced ($266,912.68 versus $281,415.23, p < .0001), while improving throughput by 21.2% (3.54%). Sensitivity analysis revealed 10% of patients need to select IONA over traditional OR arthroscopy with the revision rate remaining below 40% for the proposed state profit to be higher than the current state.ConclusionsIONA is a cost-effective alternative to traditional OR arthroscopy in patients undergoing partial medial meniscectomy. The next steps are to assess patients’ perceptions of IONA as an alternative to traditional OR arthroscopy, and to carry out clinical trials to determine the efficacy, patient-reported outcome metrics, and complications of IONA.

Patient-Reported Outcomes Measures in Rhinoplasty: Need for Use and Implementation.

Patient-reported outcome metrics (PROMs) are increasingly utilized to capture data about patients' quality of life. PROMs play an important role in the value-based health care movement by providing a patient-centered metric of quality. There are many barriers to the implementation of PROMs, and widespread adoption requires buy-in from numerous stakeholders including patients, clinicians, institutions, and payers. Several validated PROMs have been utilized by facial plastic surgeons to measure both functional and aesthetic outcomes among rhinoplasty patients. These PROMs can help clinicians and rhinoplasty patients participate in shared decision making (SDM), a process via which clinicians and patients arrive at treatment decisions together through a patient-centered approach. However, widespread adoption of PROMs and SDM has not yet been achieved. Further work should focus on overcoming barriers to implementation and engaging key stakeholders to increase the utilization of PROMs in rhinoplasty.

Spotlight in Plastic Surgery: April 2023.

Spotlight in Plastic Surgery: April 2023.

Traditional patient reported outcome metrics(PROMS) are more associated with objective physical metrics such as walking speed than standing sagittal alignment

Traditional patient reported outcome metrics(PROMS) are more associated with objective physical metrics such as walking speed than standing sagittal alignment

P55. Identifying the impact of body mass index on surgical and patient outcomes for cervical spine surgery

<h3>BACKGROUND CONTEXT</h3> Body mass index (BMI) is a common factor known to contribute to spine pathologies such as low back pain, spinal deformities and disc degeneration. BMI, both above and below normal ranges, have been shown to relate to various outcomes after lumbar spine surgery. Effects of BMI specifically after cervical spine surgery is less commonly understood. <h3>PURPOSE</h3> The aim of this research review is to clarify the role of BMI in specific cervical spine surgery outcomes. We additionally seek to study whether obese patients can be classified homogeneously, or if there are substratifications in the outcomes of obese patients by BMI. <h3>STUDY DESIGN/SETTING</h3> Retrospective study. <h3>PATIENT SAMPLE</h3> For the current study, we queried the 2013-2019 Quality Outcomes Database (QOD) cervical module. The Quality Outcomes Database is a prospective, multicenter registry designed to evaluate demographic, clinical, and patient-reported outcomes (PROs) for spine surgery. <h3>OUTCOME MEASURES</h3> Various PRO metrics were identified for the cohort, including mJOA, NRS-AP, NRS-NP, NDI, and EQ-5D at 3- and 12-month follow-up after surgical intervention. <h3>METHODS</h3> Analysis of continuous outcomes was assessed using primarily multivariate linear regression. A quasipoisson regression was utilized for hospital length of stay to account for the overdispersion assessed in multiple outcomes. For PROs, improvement in outcomes were dichotomized to achieving the MCID or not at 12-months. <h3>RESULTS</h3> Class II and III obese patients have substantially greater risk factors and poor outcomes, whereas Class I and overweight patients are not substantially different than patients with normal BMI. Adjusted for different factors, patients with class II obesity had lower odds of reoperation at 30-days (OR = 0.44 (0.22 - 0.84), p = 0.02). Class III obese patients had higher odds of postoperative complications, such as cerebrospinal fluid (CSF) leak (OR = 3.70 (1.08 - 14.7), p = 0.044) and pulmonary embolism (OR = 4.69 (1.06 - 24.5), p = 0.045). Underweight patients had a higher rate of readmission at 3 months than other classes of BMI. Other important factors associated with 30-day postoperative complications, reoperation and 3-month readmission included race, approach, and baseline ASA class. Additionally, we also demonstrate how low BMI affects surgical outcomes and PROs, with higher rates of 3-month readmission and greater hospitalization lengths. Patients with class II and III obesity had lower odds at achieving optimal mJOA at 3 months (OR = 0.8 (0.67 - 0.94), p < 0.01, OR = 0.68 (0.56 - 0.82), p < 0.001, respectively) and 12 months (OR = 0.82 (0.68 - 0.98), p = 0.03, OR = 0.79 (0.64 - 0.98), respectively). There were no significant differences between achieving MCID for mJOA. <h3>CONCLUSIONS</h3> We demonstrate how low and high BMI have unique impacts on outcomes for cervical spine surgery. Future studies ought to examine how correcting high or low BMI impacts outcomes, and whether surgeons should more aggressively work to address BMI abnormalities preoperatively. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Trends in Facial Paralysis Management: A National Survey Study.

Advances in operative management, minimally invasive procedures, and physical therapy have allowed for dramatic improvements in functional and cosmetic outcomes in patients with facial paralysis. Our goal was to evaluate the current trends and practice patterns in the diagnosis and management of facial paralysis by provider demographics. An electronic questionnaire was distributed to members of the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS). Practice patterns in the diagnosis and treatment were compared by level of training (fellowship-trained facial plastic and reconstructive surgeon versus non-fellowship trained), practice type (academic and private), practice length, patient volume, and presence of a dedicated facial nerve clinic. The bivariate associations of the outcome variables and the stratification factors were analyzed using 2-way contingency tables and Fisher's exact tests. The survey was sent to 1129 members of the AAFPRS. The response rate was 11.7% (n=132). Most respondents were fellowship-trained surgeons (79%) in the academic setting (55%), and most have been in practice for more than 10 years (53%). Practice setting and patient volume were the factors most associated with significant variations in management, including the use of facial paralysis grading scales, photography/videography, patient-reported outcome metrics, as well as differences in both noninvasive and surgical management. Based on the present study, several physician demographic factors may play a role in choosing which diagnostic and treatment options are employed for facial paralysis, with practice setting and patient volume appearing to be the 2 variables associated with the most significant differences.

Long-term bowel dysfunction and decision regret in diverticulitis: A mixed methods study

BackgroundThis study had aimed to describe long-term decision regret, bowel dysfunction, and the overall quality of life in patients with diverticulitis, and to determine if elective colectomy was associated with these patient-reported outcome measures. MethodsThis mixed-methods, survey-based study was administered to a national cohort of patients in the United States with diverticulitis. We measured decision regret (Brehaut Decision Regret), bowel dysfunction (Low Anterior Resection Syndrome score), and the overall quality of life (EuroQol 5 Dimension) in this population. We asked open-ended questions to elucidate factors that influenced patients’ choices between elective colectomy and observation. ResultsAmong the 614 respondents, 294 (48%) chose between colectomy and observational management, 94 (15%) had surgery, and 157 (26%) had major Low Anterior Resection Syndrome. Of the 294 that chose between colectomy and observational management, 51 (17%) experienced decision regret. Colectomy was associated with an average decrease in the Brehaut Decision Regret score by 6 points but was not associated with a categorical measure of decision regret (Brehaut Score ≥50). Bowel dysfunction and overall quality of life were not significantly associated with colectomy. Disease-related factors, psychosocial factors, and interactions with physicians were commonly cited as reasons for pursuing colectomy or observational management. ConclusionPatients with self-reported diverticulitis describe high levels of decision regret and bowel dysfunction regardless of chosen management strategy. Physicians should be aware that psychosocial factors can strongly influence a patient’s choice between colectomy and observational management. We advocated for future prospective studies using patient reported outcome metrics to improve outcomes in diverticulitis.

A Prospective Study on the Safety and Efficacy of Vascularized Lymph Node Transplant.

While vascularized lymph node transplant (VLNT) has gained popularity, there are a lack of prospective long-term studies and standardized outcomes. The purpose of this study was to evaluate the safety and efficacy of VLNT using all available outcome measures. This was a prospective study on all consecutive patients who underwent VLNT. Outcomes were assessed with 2 patient-reported outcome metrics, limb volume, bioimpedance, need for compression, and incidence of cellulitis. There were 89 patients with the following donor sites: omentum (73%), axilla (13%), supraclavicular (7%), groin (3.5%). The mean follow-up was 23.7±12 months. There was a significant improvement at 2 years postoperatively across all outcome measures: 28.4% improvement in the Lymphedema Life Impact Scale, 20% average reduction in limb volume, 27.5% improvement in bioimpedance score, 93% reduction in cellulitis, and 34% of patients no longer required compression. Complications were transient and low without any donor site lymphedema. VLNT is a safe and effective treatment for lymphedema with significant benefits fully manifesting at 2 years postoperatively. Omentum does not have any donor site lymphedema risk making it an attractive first choice.

Paper 18: Effect of Bone Marrow Aspirate Concentrate on Osteochondral Allograft Transplantation Incorporation: A Prospective, Randomized, Single Blind Investigation

Objectives:Osteochondral allograft transplantation for cartilage defects of the knee has demonstrated excellent long-term clinical outcomes and survival, which largely depends on successful graft osseointegration. Biologics have been suggested as a viable adjunct to enhance successful healing in several musculoskeletal applications. In the context of OCA, early results have suggested that BMAC may improve cellular repopulation and viability within the osseus portion of an implanted graft. However, few clinical studies to date have investigated the impact of BMAC on patient outcomes following OCA. The purpose of this study was to investigate the effect of bone marrow aspirate concentrate (BMAC) on osseointegration and patient-reported outcome metrics (PROMs) after osteochondral allograft transplantation in a prospective, randomized controlled single-blinded trial.Methods:Patients undergoing osteochondral allograft transplantation of the knee were consented and enrolled. Prior to surgery, patients were randomized into either the BMAC or sham incision groups. In the BMAC group, the osteochondral allograft plug was soaked in BMAC for a minimum of 2 minutes prior to implantation. All patients underwent postoperative computed tomography (CT) scanning at 6 months postoperatively and completed PROMs preoperatively, 6 months, and 1 year postoperatively. Two board-eligible orthopaedic surgeons blinded to treatment allocation independently assessed and graded each CT according to the ACTOCA system proposed by Gelber et al.Results:Thirty-six patients enrolled between April 2018 to December 2020 (17 female, 19 male) were included for analysis. There were no significant differences between the BMAC and non-BMAC groups in graft signal density (Grader 1: p=0.283, Grader 2: p=0.467), osseous integration (both graders: p=0.489), surface percentage with discernible cleft (Grader 1: 0.287, Grader 2: 0.469), or intra-articular fragments (Grader 1: p=0.617, Grader 2: p=0.810) (Table 1). A significantly greater number of patients receiving BMAC demonstrating cystic changes <3 mm (Grader 1: p=0.015, Grader 2: p=0.05) (Figure 1). At 1 year, BMAC patients reported significantly better WOMAC Pain (87.82±14.26 vs 75.80±15.56, p=0.043) and trended towards improved PROMIS Pain (54.14±8.31 vs 61.79±5.24, p=0.09).Conclusions:Patients receiving BMAC soaked OCA grafts demonstrated no difference from controls with respect to graft signal intensity, osseous integration, intra-articular fragments, or discernible graft-host clefts at 6-months postoperatively. BMAC patients had a significantly greater occurrence of small (<3 mm) cystic changes. At 1 year, BMAC patients reported significantly less pain than controls on WOMAC Pain, with similar trends on PROMIS Pain Interference.Table 1.Postoperative Imaging Characteristics (ACTOCA) by Grader.Figure 1.Distribution of cystic changes between BMAC and control groups.

Stand-Alone Cage Versus Anterior Plating for 1-Level and 2-Level Anterior Cervical Discectomy and Fusion: A Randomized Controlled Trial.

Prospective, randomized controlled trial. The aim was to compare perioperative and radiographic outcomes between stand-alone and anterior plated 1 and 2-level anterior cervical discectomy and fusion (ACDF). ACDF with interbody spacer and separate plate/screw construct (PLATE) may be associated with a higher incidence of postoperative dysphagia, increased operative time, and other complications. Therefore, some have opted to utilize an interbody cage with integrated screws and no plate (CAGE) with good results. Patients with 1-level to 2-level degenerative disease were prospectively enrolled and randomized into 1 of 2 treatment arms consisting of either PLATE or CAGE reconstruction. Patients were followed for a minimum of 1 year postoperatively. Primary endpoints included improvement on patient-reported outcome metrics, construct integrity, cervical alignment, successful arthrodesis, and subsequent revision surgeries. Forty-six patients were included: 12 with 1-level PLATE, 12 with 1-level CAGE, 12 with 2-level PLATE, and 10 with 2-level CAGE. For 1-level ACDF, PLATE patients reported worse swallow function on Swallowing Quality of Life Questionnaire at 6 weeks (P=0.050) and 6 months (P=0.042). Pseudarthrosis requiring revision was observed in one PLATE patient. For 2-level ACDF CAGE patients reported worse disability on neck disability index (P=0.037) at 6 weeks, as well as worse neck disability index (P=0.017) and visual analog scale neck (P=0.010) at 6 months. However, PLATE patients reported worse swallow function on Swallowing Quality of Life Questionnaire at 6 weeks (P=0.038). There were no differences in the rates of fusion, loss of disc height correction, subsidence, or in sagittal parameters between cohorts for both 1-level and 2-level ACDF. There was greater incidence of transient postoperative dysphagia in both single and 2-level PLATE cohorts. However, early postoperative outcomes were worse for 2-level CAGE in certain patient-reported metrics. This suggests that although anterior instrumentation may be associated with a higher likelihood of dysphagia, it may also lead to higher short-term stability and improved patient-reported outcomes for 2-level fusion.

Patient Satisfaction and Interest in Telemedicine Visits Following Total Knee and Hip Replacement Surgery.

Introduction: Telemedicine is the practice of caring for patients remotely when the patient and provider are not physically present at the same location. Within orthopedic surgery, telemedicine offers care without the typical obstacles of an in-person appointment such as difficulty ambulating following surgery and patient wait times. In this study, we evaluated patient interest and satisfaction in postoperative telemedicine visits following hip or knee arthroplasty surgery. Materials and Methods: Patients were offered either a traditional in-person or a remote telemedicine postoperative visit following surgery. Patients were asked to complete a satisfaction survey following their postoperative visit regarding their experience. Patient-survey responses as well as patient-reported outcome metrics were captured using a mobile and web-based electronic patient rehabilitation application. Results: A total of 766 patients were included in this study with 360 offered postoperative telemedicine visits and 402 offered traditional in-person visits. Two hundred fifty-nine patients reported satisfaction levels with their telemedicine visit, with 58.3% of patients characterizing their feelings with the visit as "extremely satisfied," 32.0% as "satisfied," 8.9% as "neutral," 0.3% as "dissatisfied," and 0.3% as "extremely dissatisfied." A total of 713 patients reported how the COVID-19 pandemic effected their feelings toward telemedicine with 12.9% of patients characterizing the affect as "extremely positively," 33.1% of patients as "positively," 48.9% of patients as "neutral," 3.6% of patients as "negatively," and 1.4% of patients as "extremely negatively." There were no significant differences in the change between preoperative Hip disability and Osteoarthritis Outcome Scores/Knee Injury and Osteoarthritis Outcome Score Joint Replacement, or Veterans RAND 12 Physical and Mental components and these values at 12 weeks follow-up and 1-year follow-up, respectively, in patients who had telemedicine visits versus those who had traditional in-person visits. Discussion: The results of this study demonstrate that the patients who decided to have a telemedicine visit during their postoperative visit were satisfied with their experience. Overall, COVID-19 had a positive influence on patient's feelings toward telemedicine visits.