QOLP-10. A LONGITUDINAL OBSERVATIONAL STUDY OF EXERCISE BEHAVIOR IN GLIOBLASTOMA PATIENTS TREATED WITH TUMOR-TREATING FIELDS

Glioblastoma (GBM) patients can use tumor-treating fields (TTFs) with adjuvant temozolomide (TMZ) to treat their disease. TTFs involve wearing transfixed transducers to the shaved scalp, and the transducers are wired to a battery pack that is either fixed or carried (weighing 2.7 pounds). EF-14 clinical trial did evaluate health-related quality of life with standardized patient-report outcome measures but did not measure exercise behavior. We sought to evaluate the exercise behavior of GBM patients using TTFs. We consented GBM patients who intended to use TTFs with adjuvant TMZ after completion of chemoradiation. After informed consent and before starting TTFs, patients completed a self-administered questionnaire, Godin Leisure-Time Exercise Questionnaire, to assess exercise behavior/physical function. To calculate our primary outcome of total exercise behavior, the frequency of exercise sessions per week within each intensity category was multiplied by the average reported duration, weighted by an estimate of the MET, summed across all intensities, and expressed as average MET-hr/wk. Prior work has defined that physical function can be compared as < 9 MET-h/wk vs. ≥ 9 MET-h/wk. We evaluated at baseline and up to 24-week exercise behavior in patients with TTFs vs. historical controls not using TTFs. We enrolled 19 total GBM patients, with 14 proceeding to use TTFs. Of the 14 patients on TTFs, seven patients (50%) completed ≥ 9 MET-h/wk of exercise, and this level was maintained 8, 16, and 24 weeks after starting TTFs. Six months after the completion of chemoradiation, mean MET-h/wk was decreased in the TTFs group (n=6) (10.71 sd=7.06) vs. historical controls (n=38) (27.35 sd=46.94). TTFs did not interfere with exercise behavior in our GBM cohort, but when compared to GBM patients not utilizing TTFs, there could be a long-term impact on exercise behavior. More research is needed to evaluate exercise behavior in GBM patients using TTFs.

Restricted kinematic alignment leads to uncompromised osseointegration of cementless total knee arthroplasty

Purpose While kinematic alignment (KA) total knee arthroplasty (TKA) with cemented implants has been shown to provide equivalent or better results than mechanical alignment, its combination with cementless fixation has not yet been documented. The purpose of this study is to report (1) revision rate and causes, (2) clinical results based on patient report outcome measures (PROMs), and (3) radiological signs of implant dysfunction in patients with an uncemented TKA implanted with restricted KA (rKA), after a minimum follow-up of 2 years. Methods This study included the first 100 consecutive uncemented cruciate retaining TKAs implanted between November 2015 and February 2018 by a single surgeon following rKA principles. At last follow-up, all adverse events and PROMs assessed by WOMAC, KOOS, and FJS scores were documented. Radiographic evaluation was performed to identify signs of implant loosening. Results After a mean follow-up of 49 months (32, 60), no implant revision was performed for aseptic loosening. Three revisions were performed: one for malalignment, one for a deep infection, and one for instability. The mean WOMAC score was 20.1 (0–79, 21.3), the mean KOOS score was 71.5 (19.0–96.6, 19.8), and the mean FJS score was 65.9 (0–100, 29.6). No radiological evidence of implant aseptic loosening or osteolysis was identified. Conclusion This study shows that in 99% of our cases, rKA combined with the tested cementless TKA implant allowed for adequate secondary fixation and good functional outcomes in the short term. Favourable mid- to long-term implant survivorship is anticipated. Level of evidence III.

Common peroneal nerve injury in the setting of multi-ligament knee injury: incidence and recovery in a prospective cohort

Objectives: Multiligament knee injuries (MLKI’s) are rare, but life-altering injuries which can be made worse with the presence of a concomitant nerve palsy or drop foot. Common peroneal nerve (CPN) palsy has previously been reported to be present in 5-40% of MLKI patients. The purpose of this study was to identify factors that predict CPN palsy at the time of MLKI presentation as well as determine variables that impact likelihood of neurologic recovery. Methods: Between 2006-2017, adults with MLKIs were identified at an academic level 1-trauma center and those with CPN palsy symptoms at presentation were identified. Patients were enrolled in prospective data collection and followed routinely after surgery. The primary outcome was MRC score to analyze associations between age, gender, BMI, injury severity (Schenck classification), surgical timing and presence of fibular head fracture. Secondarily, those with CPN palsy were also compared to a matched cohort of MLKI patients without CPN palsy for demographic as well as functional outcome differences using multiligament quality of life scores (MLQoL). Results: 152 patients were identified with MLKIs, of which 57 presented with a CPN palsy (38%). When comparing those with CPN palsy to those without, there were significantly more males in the CPN palsy cohort (p=0.001), significantly more lateral sided injuries – 84% versus 36% (p<0.001), and significantly more fibular head fractures – 35% versus 12% (p=0.001). There was no difference in age, BMI or injury severity or sidedness. Percentage of full or near full recovery for patients with CPN palsy at presentation was 58% (MRC>/=4). In comparing those with permanent CPN palsies to those who recovered, there was a trend towards significance for those with fibula head fractures being more likely to recover (Chi-squared 3.21, p=0.07). There was no significant difference in age, sex, BMI, sidedness, laterality, or time from presentation to surgery in terms of nerve recovery. There was no significant difference in MLQoL scores between those without CPN palsy, those with CPN palsy which recovered (MRC>/=4) and those with permanent CPN palsy (MRC<4). Analysis of MRC grading and sensory grading at presentation and factors influencing the likelihood of recovery is pending. Conclusions: The rate of CPN palsy within MLKI identified in our study matches previously reported literature. Male gender, lateral sided injury and presence of a fibular head fracture were found to be risk factors for CPN palsy at the time of injury. We found no significant difference between demographic or injury mechanism between patients who developed permanent CPN palsy and those who recovered, though there was a trend towards better recovery in those with fibular head fracture. Additionally, we found no difference between patients with CPN palsy compared to those without with respect to MLQoL scores in any domain, which calls into question whether a MLKI patient report outcome measure should incorporate nerve specific questions given the high rate of nerve injuries. The authors intend to analyze the likelihood of recovery in partial versus complete CPN palsy at the time of presentation. To our knowledge this is the largest prospectively collected dataset on CPN palsies after MLKIs, and will provide important insight into neurologic prognostication, especially when combined with previously reported data elsewhere in the literature.

Patient-Report-Outcome-Measure and Incentives for Inpatient Chronic Care in Germany

INTRODUCTION: In general, incentive tools like pay for performance (P4P) have positive effects regarding treatment quality and financial outcomes. As they are applicable to the clinical management of chronic conditions like asthma and diabetes, this article analyses their potential for multimodal complex treatment of chronic rheumatic diseases. METHODS: Cost data for chronic rheumatic diseases with and without specified complex treatments and their respective remuneration are compared to permit specific statements regarding incentive aspects in a DRG setting. Moreover, several standardized Patient-Report-Outcome-Measures (PROMs) are considered in the context of complex treatment to allow not only for efficiency, but also effectiveness evaluation. RESULTS: In total, 375 patients with complex treatment for rheumatic conditions were surveyed from 2013 to 2018. The incentive is slightly below (4,821.05 &euro;) the costs incurred for complex treatments (4,972.44 &euro;). The results of the used PROMs are positive as pain intensity decreased considerably (p &lt;.001, r=0.75) and mental state complaints were reduced (p &lt;.001). CONCLUSIONS: PROMs are valid instruments to capture changes in patient well-being. They also help to improve clinical operations and can be used for benchmarking. The P4P approach should cover the costs incurred to ensure the incentive structure.

Mapping PRO-CTCAE responses to clinician-graded adverse events, dose reductions, interruptions, and discontinuations in phase I cancer trials.

2014 Background: Typically symptomatic adverse events (sy-AEs) on clinical trials are reported by clinicians using the CTCAE. To complement clinician collected sy-AEs and understand tolerability better, the patient report outcome version of the CTCAE (PRO-CTCAE) has been developed to provide the patient (pt) perspective on severity of AEs (graded scale 0-4) and their interference in daily life (scale 0-4). The aim of this study was to correlate PRO responses with the grade (G) of AEs, dose interruptions/reductions and dose limiting toxicities (DLTs). Methods: Pts enrolled on phase 1 clinical trials at Princess Margaret were surveyed electronically on tablet using the full library of items for PRO-CTCAE. The PRO-CTCAE was administered at baseline (prior to therapy), mid-cycle 1, and mid-cycle 2. AEs on study were recorded by physicians using the CTCAE. The electronic medical records were analyzed for an association between reported sy-AEs and PRO score. Summary statistics were used to describe patient and disease characteristics, as well as the outcomes. Spearman’s method was used to correlate PRO severity and interference responses. Logistic regression was used to assess which factors were associated with CTCAE G 3-4 vs G 2 AEs. Results: We analyzed 158 pts: median age 60yrs, 77 (49%) were male; all were ECOG ≤1 and 22, 55 and 81 pts completed 1, 2 and 3 surveys, respectively. Clinician reported G2, 3 and 4 sy-AEs occurred in 81, 47 and 3 pts, respectively and all of these were related to a PRO item except 5% (4/81), 9% (4/47) and 33% (1/3), respectively because either the AE occurred after 3rd time point or patient not able to complete the PRO (encephalitis). Sy-AEs causing dose interruptions, reductions, DLTs and discontinuations occurred in 45 (28%), 12 (7.5%), 5 (3%) and 12 (7.5%) pts, respectively; with a corresponding PRO item in 40 (89%), 12 (100%), 4 (80%) and 11(92%) pts, respectively. For patients who had CTCAE G2, G3/4 AEs, interruptions and discontinuations, their severity and inference levels were positively correlated (coefficient 0.49, p < 0.001; 0.45, p < 0.001 0.59, p < 0.001, 0.86, p < 0.001). Dose interruptions (p = 0.0027) and reductions (p = 0.0061) were significantly associated with G3-4 compared to G2 AEs. Conclusions: This is the first time an association between PRO-CTCAE severity and interference; and CTCAE G2, 3, 4 AEs, dose interruptions and discontinuations has been demonstrated. Additional modelling and more patient data are being analyzed to explore the relationship.

A Systematic Review Evaluating Psychometric Properties of Parent or Caregiver Report Instruments on Child Maltreatment: Part 2: Internal Consistency, Reliability, Measurement Error, Structural Validity, Hypothesis Testing, Cross-Cultural Validity, and Criterion Validity

Aims: Child maltreatment (CM) is global public health issue with devastating lifelong consequences. Global organizations have endeavored to eliminate CM; however, there is lack of consensus on what instruments are most suitable for the investigation and prevention of CM. This systematic review aimed to appraise the psychometric properties (other than content validity) of all current parent- or caregiver-reported CM instruments and recommend the most suitable for use. Method: A systematic search of the CINAHL, Embase, ERIC, PsycINFO, PubMed, and Sociological Abstracts databases was performed. The evaluation of psychometric properties was conducted according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines for systematic reviews of patient-report outcome measures. Responsiveness was beyond the scope of this systematic review, and content validity has been reported on in a companion paper (Part 1). Only instruments developed and published in English were included. Results: Twenty-five studies reported on selected psychometric properties of 15 identified instruments. The methodological quality of the studies was overall adequate. The psychometric properties of the instruments were generally indeterminate or not reported due to incomplete or missing psychometric data; high-quality evidence on the psychometric properties was limited. Conclusions: No instruments could be recommended as most suitable for use in clinic and research. Nine instruments were identified as promising based on current psychometric data but would need further psychometric evidence for them to be recommended.

PATIENT REPORT OUTCOME MEASURE USE FOR CONCUSSION AMONG HIGH SCHOOL ATHLETIC TRAINERS

Background: Recent recommendations suggest incorporating patient-report outcome measures (PROMs) into concussion assessment batteries. Utilizing PROMs provides information on the patient’s perspective and how the concussion may influence the patient’s health status. Past studies evaluating PROM use among athletic trainers (ATs) found varying practices and barriers to implementation. However, there is limited data on use of PROMs in managing concussion among adolescent patients. Hypothesis/Purpose: To describe the use of PROMs as part of concussion assessment and treatment practices of ATs working in middle and high school settings. Methods: An online survey regarding concussion treatment perceptions and practices was distributed to a convenience sample of 5000 ATs through the NATA Survey Research Program. The survey included personal and institutional demographics, healthcare provider access and referral practices, perceptions of concussion treatment, clinical practice characteristics of concussion treatment and PROM use. The survey was pilot tested and validated in a sample of ATs prior to distribution. Analysis of the PROM section was conducted using descriptive statistics (percentages, frequencies) for this study. Results: The survey was accessed by 304 ATs (6.1% access rate) and completed by 153 ATs (58.3% completion rate). Of those, 27.2% (n=57) were employed in the middle school or high school setting and were analyzed for this study. Just over half of respondents had <10 years of experience (52.7%, n=30). Only 35.1% (n=20) of ATs reported they use PROMs as part of their clinical management of concussion. Of those who use PROMs, 75% (n=15) indicated that they use them always or almost always. The most commonly used generic PROMs were the Short Form 12 or 36 (25%, n=5) and Patient Reported Outcomes Measurement Information System (25%, n=5) and the most common specific PROMs were the Headache Impact Test (45%, n=9) and Dizziness Handicap Inventory (15%, n=3). Figure 1 shows the level of self-reported confidence of those utilizing PROMs. Barriers for PROM use included it being too time consuming (24.6%, n=14/57), lacking a support structure (15.8%, n=9/57), and not familiar with PROMs (14%, n=8/57). Close to one-fourth (22.8%, n=13/57) of respondents would be willing to use PROMs, but lacked time. Conclusion: While the use of PROMs is recommended in the evaluation and treatment of adolescent athletes, just over one-third of ATs providing care to these patients, use PROMs. Educational efforts for ATs should look to increase their familiarity and confidence when using PROMs for concussion while suggesting strategies to incorporate PROMs into practice. [Figure: see text]

Efficacy and Usability of eHealth Technologies in Stroke Survivors for Prevention of a New Stroke and Improvement of Self-Management: Phase III Randomized Control Trial

Background: Stroke is a leading cause of severe and long-term disability in developed countries. Around 15 million people suffer a stroke each year, being most of them ischemic due to modifiable risk factors. Adequate self-management abilities may help to manage the consequences of stroke, but it is unknown which specific intervention could be effective to booster these self-management abilities. Objective: To evaluate the improvement of self-management in chronic stroke survivors using decision support and self-management system (STARR). Methods: A randomized, prospective, parallel group, open, and the unicentric pilot trial will be performed. Stroke survivors and their caregivers will be randomly allocated to STARR management or standard of care. Main inclusion criteria are mild to moderate disabled first stroke adult survivor, living at home, able to cope and follow the guidelines and devices, without socio-familial exclusion. All will get a conventional treatment in the acute and subacute phase; however, in the chronic period, cases will use the developed STARR App and Decision Support System. Measurements will be performed at baseline, at 3 months, and at 6 months. Outcome measures are patient-report outcome measure of self-management competency, physical function, risk factor reduction, healthcare resource utilization, knowledge of the condition, mood, and social isolation. Discussion: If effective, the results of this study will enable stroke patients and their caregivers to deal better with the everyday life obstacles of stroke, improve the adherence of the treatment, improve the control of cardiovascular risk, and, in consequence, reduce the recurrence of secondary strokes, the number of complications, the number of consultations, and readmissions; to ultimately reduce the health systems costs. Taking into consideration that the number of stroke survivors is increasing around the world, a large number of individuals could profit from this intervention.