Standardized Patient-reported Outcome Research Articles

Validation of Patient-reported Outcomes Measurement Information System Computer Adaptive Tests in Lumbar Disk Herniation Surgery.

Inadequate validation, floor/ceiling effects, and time constraints limit utilization of standardized patient-reported outcome measures. We aimed to validate Patient-reported Outcomes Measurement Information System (PROMIS) computer adaptive tests (CATs) for patients treated surgically for a lumbar disk herniation. PROMIS, CATs, Oswestry Disability Index, and Short Form-12 measures were administered to 78 patients treated with lumbar microdiskectomy for symptomatic disk herniation with radiculopathy. PROMIS CATs demonstrated convergent validity with legacy measures; PROMIS scores were moderately to highly correlated with the Oswestry Disability Index and Short Form-12 physical component scores (r = 0.41 and 0.78, respectively). PROMIS CATs demonstrated similar responsiveness to change compared with legacy measures. On average, the PROMIS CATs were completed in 2.3 minutes compared with 5.7 minutes for legacy measures. The PROMIS CATs demonstrate convergent and known groups' validity and are comparable in responsiveness to legacy measures. These results suggest similar utility and improved efficiency of PROMIS CATs compared with legacy measures. Level II.

Heritable disorders of connective tissue: Description of a data repository and initial cohort characterization.

We describe a data repository on heritable disorders of connective tissue (HDCT) assembled by the National Institutes of Health's National Institute on Aging (NIA) Intramural Research Program between 2001 and 2013. Participants included affected persons with a wide range of heritable connective tissue phenotypes, and unaffected family members. Elements include comprehensive history and physical examination, standardized laboratory data, physiologic measures and imaging, standardized patient-reported outcome measures, and an extensive linked biorepository. The NIA made a commitment to make the repository available to extramural investigators and deposited samples at Coriell Tissue Repository (N = 126) and GenTAC registry (N = 132). The clinical dataset was transferred to Penn State University College of Medicine Clinical and Translational Science Institute in 2016, and data elements inventoried. The consented cohort of 1,009 participants averaged 39 ± 18 years (mean ± SD, range 2-95) at consent; gender distribution is 71% F and 83% self-report Caucasian ethnicity. Diagnostic categories include Ehlers-Danlos syndrome (classical N = 50, hypermobile N = 99, vascular N = 101, rare types and unclassified N = 178), Marfan syndrome (N = 33), Stickler syndrome (N = 60), fibromuscular dysplasia (N = 135), Other HDCT (N = 72). Unaffected family members (N = 218) contributed DNA for the molecular archive only. We aim to develop further discrete data from unstructured elements, analyze multisymptom HDCT manifestations, encourage data use by other researchers and thereby better understand the complexity of these high-morbidity conditions and their multifaceted effects on affected persons.

German linguistic validation of the BODY-Q: standardised PRO instrument after bariatric and bodycontouring surgery

One of the most important parts of result evaluation in plastic surgery, especially postbariatric and body-contouring surgery, is the appraisal of changes in patients' quality of life after treatment. Standardised assessments of patient-reported outcomes (PROs) are indispensable.BODY-Q (A. Klassen et al.) is a multifaceted, valid PRO instrument comprising a total of 26 scales for the evaluation of multiple factors of everyday life in order to quantify well-being, satisfaction and functionality. Each scale contains 4-10 statements, which have to be rated by patients.The BODY-Q was created pursuant to ISPOR (International Society for Pharmacoeconomics and Outcomes Research) standards and subjected to psychometric tests with great results. It is considered a standard PRO instrument for quality of life in postbariatric and body-contouring surgery.In order to expand the applicability of standardised questionnaires, ISPOR established linguistic validation guidelines, which have been applied to the BODY-Q in Dutch, Danish, Finnish and Polish.In this study, German linguistic validation was completed applying the standardised guidelines. First the BODY-Q was translated in consensus with medical expertise. Then a certified translator produced a backwards translation, which was commented on by the author. After appropriate changes were made in due consideration of these comments, interviews with patients were conducted to remove any sources of content-related misconception. Finally, the translated version was applied on patients. All the scales were translated to an easily understandable questionnaire reliable in form and content. An international collaboration aiming to centralise the results has started. Further linguistic validation procedures in other languages have been initiated, and an international cohort structure is planned to be established for body-contouring procedures in order to systematically improve treatment quality in plastic surgery.

Performance of PROMIS Global-10 to Legacy Instruments in Patients With Lateral Epicondylitis

To validate the Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 for patients who have lateral epicondylitis requiring surgical treatment in comparison with other gold standard patient-reported outcomes. Sixty-two patients with lateral epicondylitis of the elbow were prospectively enrolled before arthroscopic treatment. Inclusion criteria were patients 18years of age or older with a diagnosis of lateral epicondylitis. Each patient completed the PROMIS Global-10, EuroQol 5 Dimension (EQ-5D), American Shoulder and Elbow Surgeons (ASES) assessment form, Mayo Elbow Performance Score (MEPS), and Quick Disabilities of the Arm, Shoulder and Hand Score (QuickDASH). Spearman correlations were calculated. Bland-Altman agreement tests were conducted between estimated EQ-5D scores from the PROMIS-10 and actual EQ-5D scores. Correlation between the PROMIS-10 and the EQ-5D was excellent (0.72, P < .0001). Bland-Altman 95% limits of agreement for estimated EQ-5D scores ranged from 0.33 below to 0.21 above actual EQ-5D scores. Correlation of the PROMIS-10 physical score was good to excellent with MEPS (0.61, P < .0001) and QuickDASH scores (0.64, P < .0001) and good with the ASES (0.58, P < .0001). Correlation of the PROMIS mental scores was good with QuickDASH (0.50, P < .0001) and poor with ASES (0.26, P=.0492) and MEPS (0.37, P= .0038). The PROMIS Global-10 physical scores showed good to excellent correlation with gold standard patient-reported outcome instruments, demonstrating it is a reliable tool for outcome assessment in populations with lateral epicondylitis. Despite the excellent correlation with the EQ-5D, the 95% limit of agreement and high variability among the estimated EQ-5D scores derived from the PROMIS-10 suggests that the PROMIS-10 cannot be used as a substitute for actual EQ-5D scores to derive quality-adjusted life years for economic evaluations and cost-effectiveness research. Level II, development of diagnostic criteria on the basis of consecutive patients.

Validation of Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis in Patients With Biopsy-Proven Nonalcoholic Steatohepatitis

The chronic liver disease questionnaire for nonalcoholic steatohepatitis (CLDQ-NASH) was developed in a systematic manner for assessment of patient-reported outcomes. This instrument collects data on 36 items grouped into 6 domains: abdominal symptoms, activity/energy, emotional health, fatigue, systemic symptoms, and worry. We aimed to validate the CLDQ-NASH in a large group of patients with NASH. We collected data from patients with biopsy-proven NASH enrolled in 2 international phase 3 trials of selonsertib (NCT03053050 and NCT03053063). Our final analysis comprised 1667 patients who completed the CLDQ-NASH (age, 58 ± 9 y; 40% male; 52% with cirrhosis; and 69% with type 2 diabetes). The CLDQ-NASH was administered before treatment initiation. A standard patient-reported outcome instrument validation pipeline with internal consistency and validity assessment was applied. The domains of CLDQ-NASH showed good to excellent internal consistency: the Cronbach's α values were 0.80 to 0.94 and item-to-own-domain correlations were greater than 0.50 for 33 of 36 items. All items correlated to the greatest extent with their own domains (discriminant validity). Known-group validity tests indicated that the instrument consistently discriminated between patients with NASH based on the presence of cirrhosis (vs bridging fibrosis; all but 1 Pvalue < .02), obesity (all but 1 P value < .001), psychiatric comorbidities (all P values < .0001), fatigue (all P values < .001), and type 2 diabetes (all but 1 P value < .01). Of the CLDQ-NASH domains, the highest correlated domains with the Short Form-36 were as follows: physical functioning for activity (rho= 0.70), mental health for emotional (rho= 0.72), vitality for fatigue (rho= 0.75), and body pain for systemic (rho= 0.72) (all P values < .0001). In contrast, the domains of abdominal and worry, which are disease-specific, did not correlate with the domains in the Short Form-36 (all rho ≤ 0.50). We validated the CLDQ-NASH by an analysis of data from 1667 patients with biopsy-proven NASH enrolled in phase 3 trials, observing excellent psychometric characteristics of the instrument.

Reporting on the level of validity and reliability of questionnaires measuring Katakori severity: A systematic review.

Objectives:Katakori is a Japanese term for non-specific symptoms including discomfort or dull pain caused by muscle stiffness around the neck through the shoulders and is one of the most frequently reported symptoms in Japan. However, there has been no standardized patient-reported outcome measure to evaluate Katakori severity. This study aimed to investigate the reporting level on validity and reliability of patient-reported outcome measures of Katakori severity.Method:A systematic search in ICHUSHI, MEDLINE, EMBASE and PubMed was undertaken from inception to April 2017 without language limitations. Two authors independently undertook screening by inspecting the title and abstract. Inclusion criteria were as follows: (1) participants with Katakori symptoms, (2) reporting reliability or validity of questionnaire evaluating Katakori severity and (3) published journal articles. Studies that either of the authors retained through the screening process were inspected with full text by the two authors independently to examine eligibility of the study. Any disagreement on eligibility after full-text inspection was resolved by discussion between them. Methodological quality was rated with the COnsensus-based Standards for the selection of health Measurement INstruments checklist. Subsequently, the evidence level of each measurement property was assessed for each questionnaire. The two authors extracted data independently. Any disagreement was resolved by discussion between them.Results:Five questionnaires were identified in five studies. The Shoulder Pain and Disability Index and Scale for Measuring Felt Shoulder Stiffness had the highest level of methodological quality. However, excellent measurement properties were found in only two out of nine criteria. Furthermore, in particular, content validity was not investigated in any measure.Conclusion:There is preliminary evidence for the reliability and validity of the Shoulder Pain and Disability Index and Scale for Measuring Felt Shoulder Stiffness; however, much further research is required. Identifying or developing a patient-reported outcome measure with content validity would be a future research agenda.

Pediatric pain screening identifies youth at risk of chronic pain in sickle cell disease.

This study aimed to evaluate the preliminary validation and application of a pain screening tool to identify biopsychosocial risk factors for chronic pain in pediatric sickle cell disease (SCD) and classify youth with SCD into prognostic risk groups. Youth presenting to a pediatric SCD clinic completed the Pediatric Pain Screening Tool (PPST), a brief 9-item self-report questionnaire developed for rapid identification of risk in youth with pain complaints. Youth also completed a battery of standardized patient-reported outcomes, including pain characteristics, pain burden, functional disability, pain interference, depressive symptoms, pain catastrophizing, and fear of pain. Healthcare utilization was extracted from medical chart review. Seventy-three 8- to 18-year-olds (94% Black, 57% female) with SCD participated. The PPST demonstrated discriminant validity that ranged from fair to excellent (area under the curves (AUC)=0.74-0.93, P values<0.001) for identifying significant pain frequency, disability, pain interference, and psychosocial distress. Receiver operating characteristic curve analyses indicated that previously established cutoff scores were appropriate for the SCD sample. Participants were classified into low-risk (28.8%), medium-risk (38.4%), and high-risk (32.9%) groups, with significant group differences across measures, F(18, 116)=6.67, P<0.001. The high-risk group reported significantly higher pain intensity, pain frequency, pain burden, functional disability, pain interference, and depressive symptoms relative to both low-risk and medium-risk groups (P values<0.005). The high-risk group demonstrated a pain and psychosocial profile consistent with chronic SCD pain. The PPST may be useful for efficiently identifying youth with chronic SCD pain or those at risk of poor outcomes.

Enhancing implementation of measurement-based mental health care in primary care: a mixed-methods randomized effectiveness evaluation of implementation facilitation

BackgroundMental health care lags behind other forms of medical care in its reliance on subjective clinician assessment. Although routine use of standardized patient-reported outcome measures, measurement-based care (MBC), can improve patient outcomes and engagement, clinician efficiency, and, collaboration across care team members, full implementation of this complex practice change can be challenging. This study seeks to understand whether and how an intensive facilitation strategy can be effective in supporting the implementation of MBC. Implementation researchers partnering with US Department of Veterans Affairs (VA) leaders are conducting the study within the context of a national initiative to support MBC implementation throughout VA mental health services. This study will focus specifically on VA Primary Care-Mental Health Integration (PCMHI) programs.MethodsA mixed-methods, multiple case study design will include 12 PCMHI sites recruited from the 23 PCMHI programs that volunteered to participate in the VA national initiative. Guided by a study partnership panel, sites are clustered into similar groups using administrative metrics. Site pairs are recruited from within these groups. Within pairs, sites are randomized to the implementation facilitation strategy (external facilitation plus QI team) or standard VA national support. The implementation strategy provides an external facilitator and MBC experts who work with intervention sites to form a QI team, develop an implementation plan, and, identify and overcome barriers to implementation. The RE-AIM framework guides the evaluation of the implementation facilitation strategy which will utilize data from administrative, medical record, and primary qualitative and quantitative sources. Guided by the iPARIHS framework and using a mixed methods approach, we will also examine factors associated with implementation success. Finally, we will explore whether implementation of MBC increases primary care team communication and function related to the care of mental health conditions.DiscussionMBC has significant potential to improve mental health care but it represents a major change in practice. Understanding factors that can support MBC implementation is essential to attaining its potential benefits and spreading these benefits across the health care system.

Extensive Validation of a Disease-Specific Health Related Quality of Life Instrument in Patients With Biopsy-Proven Non-Alcoholic Steatohepatitis (NASH): Chronic Liver Disease Questionnaire-NASH (CLDQ-NASH): ACG Governors Award for Excellence in Clinical Research

Introduction: CLDQ-NASH is a disease-specific instrument developed in a systematic fashion for assessment of patient-reported outcomes (PROs) in patients with NASH. It includes 36 items grouped in 6 domains: Activity, Abdominal, Emotional, Fatigue, Systemic, and Worry domains, all scored on a Likert scale 1-7. Our aim was to validate CLDQ-NASH in a large group of patients with biopsy-proven NASH. Methods: Patients with biopsy-proven NASH were enrolled in two phase-3 clinical trials. CLDQ-NASH and other PRO instruments [Short Form-36 (SF-36), EQ-5D, Work Productivity and Activity Index (WPAI)] were administered before treatment initiation. A standard PRO instrument validation pipeline with interval consistency, construct validity, discriminant validity and convergent validity assessments were applied. Results: 1664 patients with biopsy-proven NASH completed CLDQ-NASH and other PRO instruments: 58±9 years old, 40% male, 48% with cirrhosis, 69% with type 2 diabetes. The domains of CLDQ-NASH demonstrated good to excellent internal consistency: Cronbach's alphas 0.80-0.94, item-to-own domain correlations >0.50 for 33/36 items. Confirmatory factor analysis verified the construct validity for 5 out of 6 original domains. Known groups validity tests suggest that the instrument is consistently able to discriminate between NASH patients with cirrhosis vs. bridging fibrosis (all but one p<0.02), with and without obesity (all but one p<0.001), with or without psychiatric comorbidities (all p<0.0001), with or without fatigue (all p<0.001), and with or without type 2 diabetes (all but one p<0.005). In addition, for the domains of CLDQ-NASH, the highest correlated domains of SF-36 were as follows: Physical Functioning for Activity (rho=0.70), Mental Health for Emotional (rho=0.72), Vitality for Fatigue (rho=0.75), Bodily Pain for Systemic (rho=0.72) (all p-values<0.0001). In contrast, domains of Abdominal and Worry which are more disease-specific did not show high correlations with domains in SF-36 (all rho≤0.50). In addition, the domains of CLDQ-NASH moderately correlated with work productivity and activity impairment returned by WPAI: rho from -0.39 to -0.53. Conclusion: This extensive validation of CLDQ-NASH demonstrates excellent psychometric characteristics. CLDQ-NASH performed well in this extensive round of validation in a larg of patients with biopsy-proven NASH. CLDQ-NASH is an important instrument to assess PROs in patients with NASH.

PMU60 - Utilization of Patient-Reported Outcomes in Asian Trial Literature

While overall use of patient-reported outcomes (PRO) measures has increased dramatically globally in the past 10 years, the inclusion of PRO data in controlled trials are still in its naissance, especially in the larger Asian region. PRO measures are still generally observed as a means of arriving at the current paragon of measuring the worth of a treatment - its cost-effectiveness. As the global trend in healthcare moves rapidly towards patient-centered medicine, it will become increasingly important to focus sincerely on accurate and systematic data capture in this realm. The current study seeks to track the use of PROs in clinical and controlled trials in Asia to summarize the current trends in utilization of standardized and non-standardized PRO instruments to pave the way for future investigation in systematically collecting this data alongside clinical data. A search strategy that includes terms to screen for prospective Asian clinical and controlled trials that have used survey instruments to measure PROs. The literature review will be conducted using databases like MEDLINE, PubMed, Cochrane Library and Asian registries and will be organized according to country population, sub-disease, standardized PROs used, outcome type, and purpose of study. A total of 179 studies were identified and further screened to 130 in the past 10 years by eliminating studies that were focusing on Asian patients in the Western world. Of these, 41 were based in China, 29 in Japan, 16 in Korea, 13 in India, and the rest in other South East Asian countries. The preliminary results show that the focus of PROs is mainly focused on cancer therapies, major psychoses such as Alzheimer's and schizophrenia, or degenerative diseases like Parkinson's disease. Secondary analysis will confirm the above results, identify the most common PROs utilized, and the purpose behind this type of data capture.

Abstract: Complications and Patient Reported Outcomes in Male to Female Vaginoplasty Where We Are Today a Systematic Review and Meta Analysis

PURPOSE: There is an increased need for evidence-based practices in male to female transgender (MtF) vaginoplasty. While there are a multitude of surgical techniques, there is a paucity of data comparing these procedures. A systematic review of retrospective studies on the outcomes of MtF vaginoplasty was conducted to minimize surgical complications, and improve patient outcomes for transgender patients. METHODS: Applying the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA), a comprehensive search of several databases from 1985 to November 7th, 2017 was conducted. The databases included PubMed, Ovid MEDLINE Epub Ahead of Print, Ovid Medline In-Process & Other Non-Indexed Citations, Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, and Web of Science. The resulting publications were screened, and those that met our specified inclusion/exclusion criteria were analyzed. The DerSimonian and Laird random effects model was used to pool complications and patient-reported outcomes. RESULTS: A total of 471 articles were initially identified, of which 46 met our eligibility criteria. A total of 3716 cases were analyzed. Overall incidence of complications included 2% (95% CI 1% to 6%) fistula, 14% (95% CI 10% to 18%) stenosis and strictures, and 1% (95% CI 0% to 6%) tissue necrosis, and 4% (95% Cl 2% to 10%) prolapse. Patient reported outcomes included a satisfaction rate of 93% (95% Cl 79% to 100%) with overall results, 87% (95% Cl 75% to 96%) with functional outcomes, and 90% (95% Cl 79% to 98%) with aesthetic outcomes. Ability to have orgasm was reported in 70% (95% Cl 54% to 84%) of patients. The regret rate was 1% (95% Cl 0% to 3%). The length of the vaginal cavity was 12.5 cm (95% Cl 6.3 cm to 14.4 cm). CONCLUSION: Multiple surgical techniques have demonstrated safe and reliable means of male to female vaginoplasty with low overall complication rates, and with a significant improvement in patient’s quality of life. Studies utilizing different techniques in a similar population and standardized patient-reported outcomes are required to further analyze outcomes among the different procedures and to establish best-practice guidelines.

Friday, September 28, 2018 10:45 AM–12:00 PM abstracts: how should we measure our success: 184. Clinical outcomes research in spine surgery: What are appropriate follow-up times?

BACKGROUND CONTEXT There has been a generic dictum in spine and musculoskeletal clinical research that 2 years follow-up is necessary for patient reported outcomes (PRO); however, the rationale for this duration is not evidence based. PURPOSE The purpose of this study is to determine the PRO follow-up time necessary to ensure that the effectiveness of a lumbar surgical intervention is adequately captured. STUDY DESIGN/SETTING Using PROs from the Canadian Spine Outcomes and Research Network (CSORN) prospective database the time-course to recovery plateau after lumbar spine surgery was assessed. PATIENT SAMPLE The time-course to recovery plateau after lumbar spine surgery was assessed for lumbar disc herniation, degenerative spondylolisthesis, and spinal stenosis in 1,200 patients. OUTCOME MEASURES ODI, Visual Analogue Scale (VAS) leg and back pain, and Short form (SF-12) mental and physical component summary (MCS/PCS) scores. METHODS Analysis of multicenter prospective clinical spine registry.One-way ANOVAs with post-hoc testing were used to compare the following standardized PROs at baseline, three, twelve, and twenty-four months postoperatively: RESULTS There were significant differences determined by one-way ANOVAs for all spine pathologies and specific PROs (p CONCLUSIONS Individual PROs after surgery for lumbar spine pathologies follow specific time-courses to plateaued recovery indicating a 2-year follow-up may not be required for all outcomes to be accurately assessed. Ultimately the clinical research question should dictate follow-up time and the outcome measure utilized, however there is now evidence to guide the specific duration of follow-up for each PRO.

PedsQL 3.2 Diabetes Module for Children, Adolescents, and Young Adults: Reliability and Validity in Type 1 Diabetes.

The objective of the study was to report on the measurement properties of the revised and updated Pediatric Quality of Life Inventory (PedsQL) 3.2 Diabetes Module for children, adolescents, and young adults with type 1 diabetes. The 33-item PedsQL 3.2 Diabetes Module and PedsQL Generic Core Scales were completed in a 10-site national field test study by 656 families of patients ages 2-25 years with type 1 diabetes. The 15-item Diabetes Symptoms Summary Score and 18-item Diabetes Management Summary Score were derived from the factor analysis of the items. The Diabetes Symptoms and Diabetes Management Summary Scores evidenced excellent reliability (patient self-report α = 0.88-0.90; parent proxy report α = 0.89-0.90). The Diabetes Symptoms and Diabetes Management Summary Scores demonstrated construct validity through medium to large effect size correlations with the Generic Core Scales Total Scale Score (r = 0.43-0.67, P < 0.001). HbA1c was significantly correlated with the Diabetes Symptoms and Diabetes Management Summary Scores (r = -0.21 to -0.29, P < 0.001). Minimal clinically important difference scores ranged from 5.05 to 5.55. The PedsQL 3.2 Diabetes Module Diabetes Symptoms and Diabetes Management Summary Scores demonstrated excellent measurement properties and may be useful as standardized patient-reported outcomes of diabetes symptoms and diabetes management in clinical research, clinical trials, and practice in children, adolescents, and young adults with type 1 diabetes.

Return to Recreational Sporting Activities Following Total Shoulder Arthroplasty.

Background:Patients are staying active longer and expect to return to sports or continue participating in recreational activities after total shoulder arthroplasty (TSA) for primary glenohumeral osteoarthritis.Purpose/Hypothesis:The purpose of this study was to assess the ability of patients to return to recreational sports following TSA. We hypothesized that TSA would allow a high rate of return to recreational sports.Study Design:Case series; Level of evidence, 4.Methods:All patients who underwent primary TSA by a single surgeon and were at least 2 years out from surgery were included and were studied for their ability to return to recreational activity following surgery between December 2005 and January 2015. Patient-reported outcomes were obtained, including the 12-Item Short Form Health Survey–Physical Component Summary (SF-12 PCS); Single Assessment Numeric Evaluation (SANE); Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire; American Shoulder and Elbow Surgeons (ASES) score; and satisfaction scores (10-point scale), preoperatively and at a minimum of 2 years postoperatively. Return-to-sport rates were assessed using a standardized patient-reported outcome questionnaire.Results:A total of 165 patients (186 shoulders) that received TSA met the inclusion criteria for the study. Preoperatively, 139 patients (157 shoulders) were involved in recreational sports; 16 (8.6%) shoulders required additional surgical intervention after the index TSA procedure. A significant postoperative increase was noted in the mean ASES (from 48.3 to 87.0; P < .001), QuickDASH (from 41.0 to 15.8; P < .001), SANE (from 49.1 to 81.2; P < .001), and SF-12 PCS scores (from 38.6 to 48.9; P = .004). Of the 157 shoulders in the recreational sports cohort, responses to the survey examining recreational sporting activities after surgery were available for 112 shoulders. The overall rate of return to sport or recreational activity following TSA was 93.7% (105/112 shoulders). The rate of return to recreational sporting activity equal to or better than the preinjury level was 69.7% (78/112 shoulders), while 6.3% (7/112 shoulders) of our cohort reported that they were unable to compete in recreational sports following TSA. Of the patients who participated in predominantly upper extremity sporting activities after TSA, 49% had to modify their postoperative recreational sporting activity because of lifestyle change, pain, weakness, or decreased range of motion.Conclusion:Patients undergoing TSA showed excellent postoperative improvement in their outcome scores, satisfaction, and return to athletic activities. Despite the expected decrease in activity levels with the slow progression of osteoarthritis over time until TSA was performed, almost 94% of patients successfully returned to various recreational sporting activities postoperatively. This study showed that return to recreational sports can be achieved at participation levels that are comparable with preoperative levels, but athletes in some sports such as tennis or swimming, which require more intense levels of exercise, are less likely to return to the same participation levels.

Systemwide Implementation of Patient-Reported Outcomes in Routine Clinical Care at a Children's Hospital

BackgroundDespite a growing literature on patient-reported outcomes (PROs), little has been written to guide development of a standardized, systemwide PRO program across multiple clinics and conditions. A PRO implementation program, which was created at Cincinnati Children's Hospital Medical Center, a large children's hospital, can serve as a standardized approach for the use of PROs in a clinical setting. MethodsRecommended standardized PRO implementation components include identification of a committed clinical leader and team, selection of an instrument that addresses the identified outcome of interest, specifying threshold scores that indicate when an intervention is needed, identification of clinical interventions to be triggered by threshold scores, provision of training for providers and staff involved in the PRO implementation process, and the measurement and monitoring of PRO use. ResultsFor each instrument, the completion goal is 80%, defined as the number of PRO measures that were actually completed divided by the number that should have been completed. The overall combined completion rate is 75% for the 68 unique instruments currently in use. Case studies of specific clinical team experiences demonstrate the value of using PROs and the implementation components and shows how PROs are used to promote patient-centered care. ConclusionData on PRO implementation are collected on an ongoing basis to confirm the value of the program, define ongoing improvement, and fuel collaborative research to further refine essential implementation components and successful spread. Next steps include measuring the influence of PRO use on coproduction of patient-centered clinical care and the impact PRO measurement has on patient outcomes.

Complications and Patient-Reported Outcomes in Male-to-Female Vaginoplasty-Where We Are Today: A Systematic Review and Meta-Analysis.

There is an increased need for evidence-based practices in male-to-female (MtF) transgender vaginoplasty. Although there are a multitude of surgical techniques, there is a paucity of data comparing these procedures. A systematic review of retrospective studies on the outcomes of MtF vaginoplasty was conducted to minimize surgical complications and improve patient outcomes for transgender patients. Applying the Preferred Reporting Items for Systematic Review and Meta-Analysis, a comprehensive search of several databases from 1985 to November 7, 2017, was conducted. The databases included PubMed, Ovid MEDLINE Epub Ahead of Print, Ovid Medline In-Process & Other Non-Indexed Citations, Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, and Web of Science. The resulting publications were screened, and those that met our specified inclusion/exclusion criteria were analyzed. The DerSimonian and Laird random-effects model was used to pool complications and patient-reported outcomes. A total of 471 articles were initially identified, of which 46 met our eligibility criteria. A total of 3716 cases were analyzed. Overall incidence of complications included the following: 2% (1%-6%) fistula, 14% (10%-18%) stenosis and strictures, and 1% (0%-6%) tissue necrosis, and 4% (2%-10%) prolapse (upper and lower limits of the 95% confidence interval). Patient-reported outcomes included a satisfaction rate of 93% (79%-100%) with overall results, 87% (75%-96%) with functional outcomes, and 90% (79%-98%) with esthetic outcomes. Ability to have orgasm was reported in 70% (54%-84%) of patients. The regret rate was 1% (0%-3%). The length of the vaginal cavity was 12.5 cm (6.3-4.4 cm). Multiple surgical techniques have demonstrated safe and reliable means of MtF vaginoplasty with low overall complication rates and with a significant improvement in the patient's quality of life. Studies using different techniques in a similar population and standardized patient-reported outcomes are required to further analyze outcomes among the different procedures and to establish best-practice guidelines.

Abstract 112: Systematic Review and Meta Analysis of Complications and Patient Reported Outcomes in Male to Female Vaginoplasty- Where We Are Today

PURPOSE: There is an increased need for evidence-based practices in male to female gender (MTF) vaginoplasty. While there are a multitude of surgical techniques, there is a paucity of data comparing these procedures. A systematic review of retrospective studies on the outcomes of MTF vaginoplasty was conducted to summarize evidence of MTF vaginoplasty. METHODS: Applying the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA), a comprehensive search of several databases from 1985 to November 7th, 2017, any language, was conducted. The databases included PubMed, Ovid MEDLINE Epub Ahead of Print, Ovid Medline In-Process & Other Non-Indexed Citations, Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, and Web of Science. The resulting publications were screened, and those that met our specified inclusion/exclusion criteria analyzed. The DerSimonian and Laird random effects model was used to pool complications and patient-reported outcomes. RESULTS: A total of 471 articles were initially identified, of which 46 met our eligibility criteria. A total of 3716 cases were analyzed. Overall incidence of complications included 2% (95% CI 1% to 6%) fistula, 14% (95% CI 10% to 18%) stenosis and strictures, and 1% (95% CI 0% to 6%) tissue necrosis, and 4% (95% Cl 2% to 10%) prolapse. Patient reported outcomes included a satisfaction rate of 93% (95% Cl 79% to 100%) with overall results, 87% (95% Cl 75% to 96%) with function outcome, and 90% (95% Cl 79% to 98%) with aesthetic outcome. Ability to have orgasm was reported in 70% (95% Cl 54% to 84%) of patients. The regret rate was 1% (95% Cl 0% to 3%). The width of the vaginal cavity was 12.5 cm (95% Cl 6.3 cm to 14.4 cm). CONCLUSION: Multiple surgical techniques have demonstrated safe and reliable means of male to female vaginoplasty with low overall complication rates, and significant improvements in patient quality of life. Studies utilizing different techniques in a similar population and standardized patient-reported outcomes are required to further analyze outcomes among the different procedures and to establish best-practice guidelines. O.J. Manrique: None. K. Adabi: None. K. Kiranantawat: None. J. Martinez-Jorge: None. P. Ciudad: None. Z. Wang: None.

In Search of a Gold Standard Patient-Reported Outcome Measure for Use in Chemotherapy- Induced Peripheral Neuropathy Clinical Trials.

Purpose:To test a reduced version—CIPN15—of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy scale (QLQ-CIPN20) to establish a possible gold-standard patient-reported outcome measure for chemotherapy-induced peripheral neuropathy (CIPN).Methods:Using a prospective, longitudinal, case–control design, patients (n = 121) receiving neurotoxic chemotherapy completed the CIPN15 at baseline and 12 weeks and underwent objective neurological assessment using the 5-item Total Neuropathy Score-Clinical (TNSc). Healthy controls (n = 30) completed the CIPN15 once. Structural validity was evaluated using factor analysis. Because a stable factor structure was not found, a sum score was used to evaluate measures of the CIPN15’s psychometric properties—reliability, validity, sensitivity, and responsiveness—as follows: internal consistency via Cronbach’s α and item–item correlations; test–retest reliability via correlation between 2 CIPN15 scores from each patient; concurrent validity via correlation between CIPN15 and 5-item TNSc scores; contrasting group validity via comparison of CIPN15 scores from patients and healthy controls; sensitivity via descriptive statistics (means, standard deviation, ranges); and responsiveness via Cohen’s d effect size.Results:Most patients received single agent oxaliplatin (33.7%), paclitaxel (21.2%), or more than 1 neurotoxic drug concurrently (29.8%). Factor analysis revealed no stable factor structure. Cronbach’s α for the CIPN15 sum score was 0.91 (confidence interval [CI] = 0.89-0.93). Test–retest reliability was demonstrated based on strong correlations between the 2 scores obtained at the 12-week time point (r = 0.86; CI = 0.80-0.90). The CIPN15 and 5-item TNSc items reflecting symptoms (not signs) were moderately correlated (r range 0.57-0.72): concurrent validity. Statistically significant differences were found between patient and healthy control CIPN15 mean scores (P < .0001): contrasting group validity. All items encompassed the full score range but the CIPN15 linearly converted sum score did not: sensitivity. The CIPN15 was responsive based on a Cohen’s d of 0.52 (CI = 0.25-0.79).Conclusion:The sum-scored CIPN15 is reliable, valid, sensitive, and responsive when used to assess taxane- and platinum-induced CIPN.

Sexual activity in patients with left ventricular assist devices and their partners: impact of the device on quality of life, anxiety and depression.

Prolonged support with a left ventricular assist device (LVAD) has evolved as an alternative treatment strategy for patients with end-stage heart disease. This requires a shift in focus on sexual activity and psychosocial outcomes in patients with an LVAD and their partners. This cross-sectional study was designed to capture Sexual Activities in Left Ventricular Assist Device Patients Or PaRtners (SALVADOR) perceptions on illness-related changes in the quality of sexual activity and its impact on quality of life, anxiety and depression using standardized patient-reported outcome scales (Sexual Adjustment Scale, 36-Item Short Form Health Survey, Hospital Anxiety and Depression Scale). A total of 72 patients with LVADs (50% response rate) along with 48 partners participated. For patients with an LVAD (median age 60 years; 84.7% male), median time on the device was 650 days; 69.5% stayed in long-term partnerships (median 23 years). Prevalence rates for illness-related changes in the quality of sexual activity were 58.3% for patients and 52.1% for partners. Device-related disturbances in sexual activities occurred due to battery pockets (patients/partners: 59.2%/37.6%; P = 0.006) and the driveline (46.3%/37.5%; P = 0.033) and led to significantly increased distress in patients/partners (battery pockets: 53.5%/41.3%; P = 0.006; driveline 54.9%/37.5%; P = 0.004). Disturbances in sexual activity were independently associated with higher rates of depression (odds ratio 1.33, 95% confidence interval 1.14-1.55; P = 0.001) in patients and lower mental quality of life (odds ratio 6.18, 95% confidence interval 1.13-33.98; P = 0.036) in partners. Disturbances in sexual activity are common in patients with an LVAD and their partners while the patients are on durable long-term support. Counselling on long-term adjustment should provide a platform for information seeking on illness-related changes in the quality of sexual activity.

Content validation of the SF-36v2\xae health survey with AL amyloidosis patients

BackgroundThis study examined the content validity of the SF-36v2® Health Survey (SF-36v2) in patients with AL amyloidosis using qualitative interviews with physicians and patients. The study included three distinct phases of qualitative research: concept elicitation interviews among physicians, concept elicitation interviews among patients, and cognitive debriefing interviews among patients. The concept elicitation interviews focused on areas of health-related quality of life that are affected by AL amyloidosis and may be affected by treatment, while patient cognitive debriefings aimed to confirm whether the SF-36v2 instructions, recall period, items, and response choices were comprehensive and understandable to AL amyloidosis patients.ResultsPhysicians discussed the importance of measuring physical functioning, general health, mental/emotional health, sleep, fatigue, and work impact; though they also reported that they do not routinely use a standard Patient-Reported Outcome (PRO) measure of health-related quality of life. Patients described social, physical, role, and emotional impacts of AL amyloidosis and various treatments. Cognitive debriefing interviews confirmed the relevance of the concepts measured by the SF-36v2 and indicated that patients found the SF-36v2 both easy to understand and complete, that the SF-36v2 instructions and items were comprehensive and understandable without change, and the response choices and recall period were appropriate for use with patients with AL amyloidosis.ConclusionsThe findings support the content validity of the SF-36v2 as an appropriate measure of health-related quality of life in patients with AL amyloidosis.