Classification of Adverse Events Following Surgery in Patients With Diffuse Lower-Grade Gliomas

BackgroundRecently, the Therapy-Disability-Neurology (TDN) was introduced as a multidimensional reporting system to detect adverse events in neurosurgery. The aim of this study was to compare the novel TDN score with the Landriel–Ibanez classification (LIC) grade in a large cohort of patients with diffuse lower-grade glioma (dLGG). Since the TDN score lacks validation against patient-reported outcomes, we described health-related quality of life (HRQoL) change in relation to TDN scores in a subset of patients.MethodsWe screened adult patients with a surgically treated dLGG World Health Organization (WHO) grade 2 and 3 between 2010 and 2020. Up until 2017, it consists of a retrospective cohort (n = 158). From 2017 and onwards, HRQoL was registered using EuroQoL-5-dimension, three levels of response (EQ-5D 3L) questionnaire at baseline and 3 months follow-up, in a prospectively recruited cohort (n = 102). Both the LIC grade and TDN score were used to classify adverse events.ResultsIn total, 231 patients were included. In 110/231 (47.6%) of the surgical procedures, a postoperative complication was registered. When comparing the TDN score to LIC grades, only a minor shift towards complications of higher order could be observed. EQ-5D 3L was reported for 45 patients. Patients with complications related to surgery had pre- to postoperative changes in EQ-5D 3L index values (n = 27; mean 0.03, 95% CI −0.06 to 0.11) that were comparable to patients without complications (n = 18; mean −0.06, 95% CI −0.21 to 0.08). In contrast, patients with new-onset neurological deficit had a deterioration in HRQoL at follow-up, with a mean change in the EQ-5D 3L index value of 0.11 (n = 13, 95% CI 0.0 to 0.22) compared to −0.06 (n = 32, 95% CI −0.15 to 0.03) for all other patients.ConclusionsIn patients with dLGG, TDN scores compared to the standard LIC tend to capture more adverse events of higher order. There was no clear relation between TDN severity and HRQoL. However, new-onset neurological deficit caused impairment in HRQoL. For the TDN score to better align with patient-reported outcomes, more emphasis on neurological deficit and function should be considered.

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Switching from originator adalimumab to biosimilar SB5 in a rheumatology cohort: persistence on treatment, predictors of drug interruption and safety analysis

Therapeutic Advances in Musculoskeletal Disease ◽

10.1177/1759720x211033679 ◽

2021 ◽

Vol 13 ◽

pp. 1759720X2110336

Author(s):

Cosimo Bruni ◽

Stefano Gentileschi ◽

Giovanni Pacini ◽

Marco Bardelli ◽

Lorenzo Tofani ◽

...

Keyword(s):

Adverse Events ◽

Patient Reported Outcomes ◽

Cox Regression ◽

Musculoskeletal Diseases ◽

Kaplan Meier ◽

Patient Reported ◽

Inflammatory Drugs ◽

Concomitant Medications ◽

Treatment Predictors

Aims: Medical and non-medical switching strategies have been adopted in Europe in the last few years. We aimed to investigate persistence on treatment with a SB5 Adalimumab (SB5) biosimilar after switching from Adalimumab (ADA) originator among patients with inflammatory rheumatic musculoskeletal diseases (iRMD), identifying possible predictors of drug interruption and describing adverse events. Method: iRMD patients previously switched to SB5 after at least 6 months of ADA were enrolled. Data on concomitant medications, disease flares, and persistence on SB5 up to the last available follow up were collected retrospectively. Kaplan–Meier and Cox regression models were used. Result: A total of 172 patients (106 females, ADA duration 5.8 ± 3.8 years) were enrolled, including 34 rheumatoid arthritis, 59 psoriatic arthritis, and 61 axial spondyloarthritis patients. In a 10 ± 3 months follow up, 65 (37.8%) patients presented with adverse events, with 46 (26.7%) showing a clinically defined disease flare (no disease activity and patient reported outcomes assessment were available); 24 patients interrupted SB5 permanently (among them, 11 back-switched to ADA and 8 were prescribed a different biological therapy). Probability of persistence on SB5 was 94.7% at 6 months and 85.1% at 12 months. Baseline corticosteroid [hazard ratio (HR) 3.209, 95% confidence interval (CI) 1.193–8.635, p = 0.021] and therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) (HR 2.876, 95% CI 1.229–6.727, p = 0.015), as well as the baseline corticosteroid dose (HR 1.200, 95%CI 1.026–1.403, p = 0.022) were predictors of drug interruption. Conclusion: Our data on persistence of treatment and adverse events are in line with previous reports. Further large cohort studies may confirm baseline corticosteroid and NSAIDs use as predictors of SB5 interruption, helping to identify patients at higher risk of failure after switching.

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Intravenous ferric derisomaltose versus oral iron for iron deficient pregnant women: a randomised controlled trial

10.22541/au.163483717.75251987/v1 ◽

2021 ◽

Author(s):

Rebecka Hansen ◽

Veronika Sommer ◽

Anja Pinborg ◽

Lone Krebs ◽

Lars Thomsen ◽

...

Keyword(s):

Adverse Events ◽

Pregnant Women ◽

Patient Reported Outcomes ◽

Well Being ◽

Oral Iron ◽

Maximum Likelihood Estimates ◽

Psychological Well Being ◽

Patient Reported ◽

Randomised Controlled

Objective:Compare the efficacy of intravenous ferric derisomaltose (FDI) with oral iron in pregnant women with persistent iron deficiency.Design:Single-centre, open-labelled, randomised controlled trial.Setting:Danish university hospital.Population:Women 14–21 weeks pregnant with persistent iron deficiency (ferritin <30 µg/L).Methods:Allocation to 1,000 mg intravenous FDI (single-dose) or 100 mg elemental oral iron daily (FA). Assessment of blood tests, patient reported outcomes (fatigue and quality of life) and adverse events throughout eighteen weeks’ follow-up.Main_outcome_measures:Proportion of non-anaemic (haemoglobin ≥11 g/dL) women throughout follow-up (primary endpoint), assessed by Kaplan-Meier estimates compared between groups by risk difference analysis. Change in haematological markers and patient reported outcomes, assessed by restricted maximum likelihood estimates compared between groups by a repeated measures mixed model.Results:From July 2017 through February 2020, 100 women were randomised to FDI and 101 to FA. In the FDI vs. FA group 89% vs. 88% were non-anaemic prior to inclusion. Throughout follow-up, 91% vs. 73% were non-anaemic in favor of FDI (18% difference, 95% CI 0.10–0.25, p<0.001). The haemoglobin least-squares mean increase was significantly greater in the FDI vs. FA group at week six (0.4 vs. -0.2 g/dL, p<0.001), twelve (0.5 vs. 0.1 g/dL, p<0.001) and eighteen (0.8 vs. 0.5 g/dL, p=0.01). Improvements in patient reported fatigue and psychological well-being were greater in the FDI group at weeks three and six. The incidence of treatment related adverse events was comparable across treatments.Conclusions:FDI was superior for avoiding anaemia compared to oral treatment, and biochemical superiority was accompanied by improved fatigue and psychological well-being.

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Evaluation of immune-related adverse events (irAE): Utilizing the patient-reported outcomes of the common terminology criteria for adverse events (PRO-CTCAE) in a phase II study of ipilimumab (ipi) in men with castration-sensitive prostate cancer (CSPC).

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e24174 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e24174-e24174

Author(s):

Daniel Vargas Pivato de Almeida ◽

Justine Anderson ◽

Daniel Costin Danila ◽

Michael J. Morris ◽

Susan F. Slovin ◽

...

Keyword(s):

Clinical Trial ◽

Adverse Events ◽

Patient Reported Outcomes ◽

Potential Role ◽

De Novo ◽

Limited Data ◽

Patient Reported ◽

The Common ◽

Clinical Trial Information

e24174 Background: Incorporation of the PRO-CTCAE during chemotherapy is associated with fewer ER visits and improved survival. Limited data exist using this tool to capture irAE in immunotherapy trials. We collected select PRO-CTCAEs in a clinical trial evaluating an immune checkpoint inhibitor (ICI) in patients (pts) with CSPC. Methods: Cohort A (Coh A) enrolled de novo metastatic CSPC; Cohort B (Coh B) enrolled recurrent CSPC after radical prostatectomy (RP). Treatment consisted of 4 doses of ipi and 8 months of androgen deprivation therapy (ADT) in Coh A & B, and RP in Coh A. PRO-CTCAEs were collected at each ipi or ADT administration, and during follow-up. PRO-CTCAE items included abdominal pain, diarrhea, fatigue, anorexia, nausea, vomiting, rash and pruritus, with the correspondent attributes of frequency (freq), severity (sev), interference (int), and presence. Results: 16 pts were treated (Coh A: 7; Coh B: 9) with 181 matched pairs of PRO-CTCAE and CTCAE. The study was terminated early for an unfavorable risk:benefit ratio. PRO-CTCAE completion at required visits was 85.4% in Coh A and 98.1% in Coh B. Cohen’s kappa coefficients was lowest for pruritus (k = 0.10, slight agreement) and highest for rash (k = 0.64, moderate agreement). CTCAE captured diarrhea in 10 pts, 4 of whom received steroids. 75% (3/4) of pts receiving steroids graded diarrhea as ‘frequently’ or ‘almost constantly’ on the PRO-CTCAE while 66.7% (4/6) of those who did not receive steroids reported the same frequency. Conclusions: IrAE were more commonly reported and of higher grade by patients using the PRO-CTCAE as compared to clinician reporting, consistent with existing literature in non-ICI studies. Diarrhea as reported by the PRO-CTCAE did not associate with steroid use in this small trial. Further studies are needed to evaluate irAE using PRO-CTCAEs and the potential role in management of these toxicities. Clinical trial information: NCT02020070 . [Table: see text]

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3 fraction pencil-beam scanning proton accelerated partial breast irradiation: early provider and patient reported outcomes of a novel regimen

Radiation Oncology ◽

10.1186/s13014-019-1417-7 ◽

2019 ◽

Vol 14 (1) ◽

Cited By ~ 4

Author(s):

Robert W. Mutter ◽

Krishan R. Jethwa ◽

Karthik Gonuguntla ◽

Nicholas B. Remmes ◽

Thomas J. Whitaker ◽

...

Keyword(s):

Adverse Effects ◽

Adverse Events ◽

Patient Reported Outcomes ◽

Partial Breast Irradiation ◽

Skin Dose ◽

Pencil Beam ◽

Beam Scanning ◽

Pencil Beam Scanning ◽

Patient Reported

Abstract Background and purpose To report dosimetry and early adverse effects, aesthetic, and patient-reported outcomes of a prospective study of 3-fraction pencil-beam scanning (PBS) proton accelerated partial irradiation (APBI). Materials and methods Eligibility included women age ≥ 50 years with estrogen receptor positive (ER+), sentinel lymph node negative invasive or in-situ breast cancer measuring ≤2.5 cm. The prescription was 21.9 Gy (RBE 1.1) in 3 daily fractions to the post-operative tumor bed with a 1 cm expansion. Toxicities were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, 10-point Linear Analog Scale Assessment, Patient-Reported Outcomes Version of the CTCAE, and the Harvard Breast Cosmesis Scale. Results Seventy-six women were treated between 2015 and 2017. The median breast volume receiving 50% of prescription or more was 28%. Median mean heart, mean ipsilateral lung, and maximum skin dose were 0 Gy, 0.1 Gy, and 20.6 Gy, respectively. With a median follow-up of 12 months, no treatment-related toxicity grade ≥ 2 has been observed. Most common grade 1 adverse events were dermatitis (68%) and skin hyperpigmentation (18%). At 12 months, the only persistent toxicities were one patient with grade 1 breast edema and one patient with a grade 1 seroma. 90% of patients reported quality of life as ≥7 out of 10 (0 indicating “as bad as it can be” and 10 indicating “as good as it can be”) and 98% of patients reported excellent or good cosmesis. Conclusion 3-fraction PBS proton APBI is well tolerated with low rates of physician and patient reported early adverse effects. Follow-up is ongoing to assess late toxicities and disease control outcomes. Further investigation of this novel adjuvant treatment strategy is warranted.

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Feasibility of Implementing the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in a Multicenter Trial: NCCTG N1048

Journal of Clinical Oncology ◽

10.1200/jco.2018.78.8620 ◽

2018 ◽

Vol 36 (31) ◽

pp. 3120-3125 ◽

Cited By ~ 18

Author(s):

Ethan Basch ◽

Amylou C. Dueck ◽

Lauren J. Rogak ◽

Sandra A. Mitchell ◽

Lori M. Minasian ◽

...

Keyword(s):

Adverse Events ◽

National Cancer Institute ◽

Patient Reported Outcomes ◽

Multicenter Trial ◽

Self Report ◽

Preoperative Radiation ◽

Time Points ◽

Patient Reported ◽

The Common

Purpose The US National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed to enable patient reporting of symptomatic adverse events in oncology clinical research. This study was designed to assess the feasibility and resource requirements associated with implementing PRO-CTCAE in a multicenter trial. Methods Patients with locally advanced rectal cancer enrolled in the National Cancer Institute–sponsored North Central Cancer Treatment Group (Alliance) Preoperative Radiation or Selective Preoperative Radiation and Evaluation before Chemotherapy and Total Mesorectal Excision trial were asked to self-report 30 PRO-CTCAE items weekly from home during preoperative therapy, and every 6 months after surgery, via either the Web or an automated telephone system. If participants did not self-report within 3 days, a central coordinator called them to complete the items. Compliance was defined as the proportion of participants who completed PRO-CTCAE assessments at expected time points. Results The prespecified PRO-CTCAE analysis was conducted after the 500th patient completed the 6-month follow-up (median age, 56 years; 33% female; 12% nonwhite; 43% high school education or less; 5% Spanish speaking), across 165 sites. PRO-CTCAE was reported by participants at 4,491 of 4,882 expected preoperative time points (92.0% compliance), of which 3,771 (77.2%) were self-reported by participants and 720 (14.7%) were collected via central coordinator backup. Compliance at 6-month post-treatment follow-up was 333 of 468 (71.2%), with 122 (26.1%) via backup. Site research associates spent a median of 15 minutes on PRO-CTCAE work for each patient visit. Work by a central coordinator required a 50% time commitment. Conclusion Home-based reporting of PRO-CTCAE in a multicenter trial is feasible, with high patient compliance and low site administrative requirements. PRO-CTCAE data capture is improved through centralized backup calls.

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Prospective, randomized, multicenter study with 2-year follow-up to compare the performance of decompression with and without interlaminar stabilization

Journal of Neurosurgery Spine ◽

10.3171/2017.11.spine17643 ◽

2018 ◽

Vol 28 (4) ◽

pp. 406-415 ◽

Cited By ~ 18

Author(s):

Sven Schmidt ◽

Joerg Franke ◽

Michael Rauschmann ◽

Dieter Adelt ◽

Matteo Mario Bonsanto ◽

...

Keyword(s):

Adverse Events ◽

Patient Reported Outcomes ◽

Walking Distance ◽

Pivotal Trial ◽

Significant Difference ◽

Patient Reported ◽

Severe Adverse Events ◽

Us Fda ◽

Foraminal Height

OBJECTIVESurgical decompression is extremely effective in relieving pain and symptoms due to lumbar spinal stenosis (LSS). Decompression with interlaminar stabilization (D+ILS) is as effective as decompression with posterolateral fusion for stenosis, as shown in a major US FDA pivotal trial. This study reports a multicenter, randomized controlled trial in which D+ILS was compared with decompression alone (DA) for treatment of moderate to severe LSS.METHODSUnder approved institutional ethics review, 230 patients (1:1 ratio) randomized to either DA or D+ILS (coflex, Paradigm Spine) were treated at 7 sites in Germany. Patients had moderate to severe LSS at 1 or 2 adjacent segments from L-3 to L-5. Outcomes were evaluated up to 2 years postoperatively, including Oswestry Disability Index (ODI) scores, the presence of secondary surgery or lumbar injections, neurological status, and the presence of device- or procedure-related severe adverse events. The composite clinical success (CCS) was defined as combining all 4 of these outcomes, a success definition validated in a US FDA pivotal trial. Additional secondary end points included visual analog scale (VAS) scores, Zürich Claudication Questionnaire (ZCQ) scores, narcotic usage, walking tolerance, and radiographs.RESULTSThe overall follow-up rate was 91% at 2 years. There were no significant differences in patient-reported outcomes at 24 months (p > 0.05). The CCS was superior for the D+ILS arm (p = 0.017). The risk of secondary intervention was 1.75 times higher among patients in the DA group than among those in the D+ILS group (p = 0.055). The DA arm had 228% more lumbar injections (4.5% for D+ILS vs 14.8% for DA; p = 0.0065) than the D+ILS one. Patients who underwent DA had a numerically higher rate of narcotic use at every time point postsurgically (16.7% for D+ILS vs 23% for DA at 24 months). Walking Distance Test results were statistically significantly different from baseline; the D+ILS group had > 2 times the improvement of the DA. The patients who underwent D+ILS had > 5 times the improvement from baseline compared with only 2 times the improvement from baseline for the DA group. Foraminal height and disc height were largely maintained in patients who underwent D+ILS, whereas patients treated with DA showed a significant decrease at 24 months postoperatively (p < 0.001).CONCLUSIONSThis study showed no significant difference in the individual patient-reported outcomes (e.g., ODI, VAS, ZCQ) between the treatments when viewed in isolation. The CCS (survivorship, ODI success, absence of neurological deterioration or device- or procedure-related severe adverse events) is statistically superior for ILS. Microsurgical D+ILS increases walking distance, decreases compensatory pain management, and maintains radiographic foraminal height, extending the durability and sustainability of a decompression procedure.Clinical trial registration no.: NCT01316211 (clinicaltrials.gov)

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Early Imaging for Back Pain in Older Adults

10.1093/med/9780190223700.003.0015 ◽

2016 ◽

Author(s):

Christoph I. Lee

Keyword(s):

Older Adults ◽

Back Pain ◽

Resource Use ◽

Patient Reported Outcomes ◽

Additional Information ◽

Patient Reported ◽

Early Imaging ◽

Study Methodology ◽

New Onset

This chapter, found in the back pain section of the book, provides a succinct synopsis of a key study examining the use of early imaging for back pain in older adults. This summary outlines the study methodology and design, major results, limitations and criticisms, related studies and additional information, and clinical implications. The study showed that early imaging for new onset back pain among older adults presenting to primary care was not associated with improved patient-reported outcomes at 1-year follow-up. However, patients undergoing such early imaging had substantially higher resource use and reimbursement expenditures than those not undergoing early imaging. In addition to outlining the most salient features of the study, a clinical vignette and imaging example are included in order to provide relevant clinical context.

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Serious Adverse Events Significantly Reduce Patient-Reported Outcomes at 2-Year Follow-up

Spine ◽

10.1097/brs.0000000000002479 ◽

2018 ◽

Vol 43 (11) ◽

pp. 747-753 ◽

Cited By ~ 1

Author(s):

Andrew J. Pugely ◽

Michael P. Kelly ◽

Christine R. Baldus ◽

Yubo Gao ◽

Lukas Zebala ◽

...

Keyword(s):

Adverse Events ◽

Patient Reported Outcomes ◽

Serious Adverse Events ◽

Patient Reported

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Individualized cancer follow-up supported by electronic Patient-Reported Outcomes: Development and evaluation (Preprint)

10.2196/preprints.18397 ◽

2020 ◽

Author(s):

Sissel Ravn ◽

Henriette Vind Thaysen ◽

Lene Seibaek ◽

Victor Jilbert Verwaal ◽

Lene Hjerrild Iversen

Keyword(s):

Ct Scan ◽

Advanced Cancer ◽

Patient Reported Outcomes ◽

Cost Benefit Analysis ◽

Cost Benefit ◽

Structured Interviews ◽

European Organization ◽

Individualized Care ◽

Patient Reported

BACKGROUND Cancer survivors experience unmet needs during follow-up. Besides recurrence, a follow-up includes detection of late side effects, rehabilitation, palliation and individualized care. OBJECTIVE We aimed to describe the development and evaluate the feasibility of an intervention providing individualized cancer follow-up supported by electronic patient-reported outcomes (e-PRO). METHODS The study was carried out as an interventional study at a Surgical and a Gynecological Department offering complex cancer surgery and follow-up for advanced cancer. The e-PRO screened for a priori defined clinical important symptoms and needs providing individualized follow-up. We included following questionnaires in the e-PRO; the general European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EORTC validated for colorectal and ovarian cancer patients. To support individualization, we included three prioritized issues of the patient’s preference in each e-PRO. The response-algorithm was aggregated based on the severity of the patient’s response. To ensure the sensitivity of the e-PRO, we performed semi-structured interviews with five patients. All clinicians (surgeons and gynecologists) performing the consultations reviewed the e-PRO. The evaluation was divided in two, 1)The feasibility was assessed by a)Patients’ response rate of the e-PRO, b)Number of follow-up visits documenting the use of e-PRO and c)Patients’ prioritized issues prior to the consultation(‘yes’ / ‘no’), and after the follow-up 2)Patients assessment of a)The need and purpose of the follow-up visit and b)the support provided during the follow-up visit. RESULTS In total, 187 patients were included in the study, of which 73%(n=136/187) patients responded to the e-PRO and were subjected to an individualized follow-up. The e-PRO was documented as applied in 79% of the follow-up visits. In total, 23% of the prioritized issues did not include a response. Stratified by time since surgery, significantly more patients did not fill out a prioritized issue had a follow-up >6 months since surgery. In total, 72 % follow-up visits were evaluated to be necessary in order to discuss the outcome of the CT scan, symptoms, and/or prioritized issues. Contrary, 19% of the follow-up visits were evaluated to be necessary only to discuss the result of the CT scan. A range from 19.3–56.3% of patients assessed the follow-up visit to provide support with respect to physical (42% of patients), mental (56%), sexual (19%) or dietary (27%) issues. Further, a range from 34–60% of the patients reported that they did not need support regarding physical (43% of patients), mental (34%), sexual (63%) or dietary (57%) issues. CONCLUSIONS An individualized follow-up based on e-PRO is feasible, and support most patients surgically treated for advanced cancer. However, results indicate that follow-up based on e-PRO may not be beneficial for all patients and circumstances. A thorough cost-benefit analysis may be warranted before implementation in routine clinic.

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Minimum 10-Year Outcomes of Primary Arthroscopic Transosseous-Equivalent Double-Row Rotator Cuff Repair

The American Journal of Sports Medicine ◽

10.1177/03635465211015419 ◽

2021 ◽

pp. 036354652110154

Author(s):

Adam M. Johannsen ◽

Justin W. Arner ◽

Bryant P. Elrick ◽

Philip-C. Nolte ◽

Dylan R. Rakowski ◽

...

Keyword(s):

Rotator Cuff ◽

Revision Surgery ◽

Rotator Cuff Repair ◽

Patient Reported Outcomes ◽

Long Term Results ◽

Double Row ◽

Kaplan Meier ◽

Patient Reported ◽

Cuff Repair

Background: Modern rotator cuff repair techniques demonstrate favorable early and midterm outcomes, but long-term results have yet to be reported. Purpose: To determine 10-year outcomes and survivorship after arthroscopic double-row transosseous-equivalent (TOE) rotator cuff repair. Study Design: Case series; Level of evidence 4. Methods: The primary TOE rotator cuff repair procedure was performed using either a knotted suture bridge or knotless tape bridge technique on a series of patients with 1 to 3 tendon full-thickness rotator cuff tears involving the supraspinatus. Only patients who were 10 years postsurgery were included. Patient-reported outcomes were collected pre- and postoperatively, including American Shoulder and Elbow Surgeons (ASES), 12-Item Short Form Health Survey (SF-12), Single Assessment Numeric Evaluation (SANE), shortened version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH), and satisfaction. Kaplan-Meier survivorship analysis was performed. Failure was defined as progression to revision surgery. Results: A total of 91 shoulders (56 men, 31 women) were included between October 2005 and December 2009. Mean follow-up was 11.5 years (range, 10.0-14.1 years). Of 91 shoulders, 5 (5.5%) failed and required revision surgery. Patient-reported outcomes for patients who survived were known for 80% (69/86). Outcomes scores at final follow-up were as follows: ASES, 93.1 ± 10.8; SANE, 87.5 ± 14.2; QuickDASH, 11.1 ± 13.5; and SF-12 physical component summary (PCS), 49.2 ± 10.1. There were statistically significant declines in ASES, SANE, and SF-12 PCS from the 5-year to 10-year follow-up, but none of these changes met the minimally clinically important difference threshold. Median satisfaction at final follow-up was 10 (range, 3-10). From this cohort, Kaplan-Meier survivorship demonstrated a 94.4% survival rate at a minimum of 10 years. Conclusion: Arthroscopic TOE rotator cuff repair demonstrates high patient satisfaction and low revision rates at a mean follow-up of 11.5 years. This information may be directly utilized in surgical decision making and preoperative patient counseling regarding the longevity of modern double-row rotator cuff repair.

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