Patient-reported Outcome Tools Research Articles

Patient-reported outcomes integrated within electronic medical record in patients with head and neck cancer.

e14026 Background: Patient-reported outcome (PRO) tools have been shown to improve outcomes including overall survival for cancer patients. However, routine implementation of PROs in clinical practice within the electronic medical record (EMR) remains limited. We studied the use of a PRO tool for patients with head and neck cancer (HNC) integrated in an EMR. Methods: Between August 2017 and December 2019 patients with newly diagnosed HNC were surveyed at baseline, then every 3 months using the FACT-G7 and FACT H&N (Version 4). A medical assistant (MA) performed a baseline survey around the time of diagnosis and then notified patients electronically every 3 months for two years and then every 6 months until patients completed their 5 years of surveillance. Patients who did not respond to online PRO surveys could complete them via telephone appointments with MAs, or in office pre-rooming. Abnormal findings on PRO surveys were referred to appropriate members of the care team or the treating ENT physicians. Results: 290 patients received baseline surveys. Patients received up to a maximum of 8 subsequent surveys (table). Out of a total of 597 electronic surveys, 585 (97.9%) were completed. The percentage of patient completing each survey ranged from 92-100%. Conclusions: PRO tools can be effectively deployed within the EMR for HNC patients with a high completion rate provided that there is strong engagement from a dedicated member of the care team. This has important implications for designing clinical trials and symptom monitoring in clinical practices that incorporate EMRs.

Distress screening through PROMIS at an academic cancer center and network site: Implementation of a hybrid model.

2021 Background: The NCCN guidelines recommend routine distress screening of patients with cancer, but the implementation of such programs is inconsistent. Up to one in three such patients experience distress, however fewer than half of them are identified and referred for supportive services. Methods: We implemented a hybrid (electronic and paper) distress screening tool, using a modified version of the PROMIS-Global Health questionnaire. Patients received either an electronic or in-clinic paper questionnaire to assess overall health and distress at the Stanford Cancer Center and its associated integrated network site. Iterative changes were made including integration with the electronic health record (EHR) to trigger questionnaires for appointments every 60 days. A consensus “positive screen” threshold was defined, with data collected on responses and subsequent referrals placed to a supportive care services platform. Results: Between June 2015 and December 2017, 53,954 unique questionnaires representing 12,744 distinct patients were collected, with an average completion rate of 58%. Approximately 30% of the questionnaires were completed prior to the visit electronically through a patient portal. The number of patients meeting the positive screen threshold remained ~ 40% throughout this period. Following assessment by the clinical team, there were 3763 referrals to cancer supportive services. Among the six most common referral categories, those with a positive screen were more likely to have a referral placed (OR 6.4, 95% CI 5.8-6.9 p- < 0.0001), with a sensitivity of 80% and a specificity of 61%. However, 89% of responses with a positive screen did not have a referral to supportive care services. Conclusions: The hybrid electronic and paper use of a commonly available patient reported outcome tool, as a high throughput distress screening tool, is feasible at a multi-site academic cancer center. Our positive screen rate for referrals was sensitive and consistent, but with a low positive predictive value. This screening also resulted in variable clinical response and overall increased clinical burden. Future directions for our group have included refining the threshold for a positive screen and implementation of a real-time response system, especially to address acute concerns.

Integrating PROs with prognostic value into oncologic care: High ESAS global distress score associated with lower overall survival in advanced cancer patients.

12021 Background: Despite compelling data supporting their use, patient reported outcomes (PROs) are not widely integrated into routine cancer care. In our Palliative Care (PC) practice, all patients complete the Edmonton Symptom Assessment Scale (ESAS), a simple, validated 10-item PRO tool which uses a 0 to 10 rating of 10 common symptoms (pain, fatigue, nausea, drowsiness, appetite, sleep, dyspnea, well-being, anxiety & depression). Our team has previously validated the Global Distress Score (GDS), a sum of 9 physical + psychosocial ESAS items. Here, we studied the implementation of the GDS as a streamlined way to capture the overall symptom burden while providing prognostic value. Methods: We queried a PC database for patients w metastatic cancer at time of 1st PC visit. GDS was calculated & grouped into 3 cohorts based on previous work & clinical experience: high (GDS of 35+), Moderate (16-34) or Low (0-15). Overall Survival was defined as time from 1st PC visit date to death. Regression analysis, ANOVA and t-tests were conducted. Results: 333 patients met the inclusion criteria: median age 62.4y (range 20.5-88.4y), 25 AYA (15-39y), 169 mid age (35-64y), 140 seniors (65y+); 190 female 143 male; median prior therapies 2 (range 0-11), 227 patients were in 2nd line + above therapy. Median ECOG PS 2; 124 patients w ECOG PS 3 & 33 w ECOG PS 4. 262 patients had died at time of analysis. Lower OS was associated w higher GDS (r 0.21, P < 0.001). OS in Low, Mod, High GDS cohorts was 13.1m, 7.9m, & 3.7m, respectively (p < 0.001). There were no sig OS difference between 3 age cohorts (AYA 5.2m, mid age 6m, seniors 5.4m, p0.56). Conclusions: Higher GDS score was associated with a clinically significant decrease in overall survival highlighting the potential of the ESAS as a PRO tool in prognostication and clinical decision making for patients with advanced cancers with a high symptom burden. In the realm of increasingly complex PRO instruments, the ESAS represents a simple, well-validated tool which, in our studies and 25 years of clinical experience, takes the patient less than a minute to complete, with subscores such as the GDS which carry a highly prognostic utility for patients with advanced cancers.

Adoption patterns of an electronic patient-reported outcomes tool in oncology.

e19127 Background: Patient-reported outcomes (PROs) are critical for the delivery of patient-centric care. Previous research has shown that the use of PROs can impact clinical outcomes in Oncology. Despite these benefits, PROs have not been widely implemented as part of standard of care. Significant barriers exist for its adoption including lack of integration between PRO tools and electronic health record systems (EHRs). We developed MSK Engage, a home-grown PRO tool integrated with the EHR and embedded within MSK's patient portal (MyMSK). It was launched in late 2015 and it is currently used enterprise-wide for both standard of care and research purposes. The purpose of this study was to describe the usage patterns of PROs in a real-world setting. Methods: We conducted a retrospective analysis of patients that have been assigned at least one MSK Engage survey instrument between 2015 and 2019. Patient demographic information was extracted from the EHR system. Usage patterns including the number of survey instruments assigned and completed were extracted from MSK Engage. Survey completion rates were stratified by patient demographic information and number of assigned surveys. We performed univariate and multivariate analyses to identify factors associated with survey completion rates. Results: During the study period, 57 survey instruments were implemented, with the majority being used for standard of care (41 for standard of care only, 9 for research protocols, 6 for standard of care and research, and one for a quality improvement initiative). In total, 246,638 patients were assigned 557,559 surveys. Of those, 146,505 patients completed a total of 265,174 surveys, with a median completion time of 3 minutes. Among the patients that were assigned a survey, 73.7% were women. Women in our sample were older than men, with median age 52 and 47 years old, respectively. Men were more likely to complete the assigned surveys with 61.2% completion rate among men and 43.3% among women (p < 0.001). On multivariate analysis, men were less likely to miss surveys than women (odds ratio [OR], 0.49; 95% CI, 0.48-0.49). We also identified a significant correlation between the survey completion rate and number of assigned surveys, demonstrating that assigning a large number of surveys for each patient can lead to a reduced survey response. Conclusions: Providers have quickly adopted MSK Engage demonstrating that it is feasible to incorporate PROs as part of standard of care. Patients are willing to answer PROs; however, it is important to mindful when assigning surveys to avoid negative effects of survey burden.

Minimum Clinically Important Difference in Short Musculoskeletal Function Assessment: What Change Matters in Ankle Fractures.

Accurate interpretation of the clinical significance of patient-reported outcome (PRO) research requires determination of the threshold where a difference in PRO score represents a clinical benefit to patients, termed the minimum clinically important difference (MCID). The Short Musculoskeletal Function Assessment (SMFA) is one of the most commonly utilized PRO tools in orthopaedics. However, to date, no MCID has been determined. The purpose of this study was to define the MCID for the SMFA. A prospectively collected ankle fracture outcomes registry was reviewed between 2014 and 2016. Inclusion criteria were isolated ankle fracture, treatment with open reduction and internal fixation, and 6-week follow-up with completed SMFA. Two commonly utilized methods to determine the MCID, the anchor and distribution methods, were performed in this study. Overall, 105 patients met inclusion/exclusion criteria. Utilizing both the overall health anchor and the mental and emotional health anchor, the MCID was 7.3 (n = 17 and n = 19, respectively). The distribution method MCID was 7.0 (n = 105). Our study found the MCID values for the SMFA to converge around a value of 7 for the 3 analyses. This indicates that a threshold of 7 should be applied to studies utilizing the SMFA to determine the clinical significance of the results.

Patient-reported symptoms in metastatic gastric cancer patients in the last 6months of life.

Patients with metastatic gastric cancer have poor survival outcomes and may experience high symptom burden. We evaluated symptom trajectory and risk factors for increased symptom severity among metastatic gastric cancer patients during the last 6months of life. We conducted a retrospective cohort study among patients ≥ 18years diagnosed with metastatic gastric cancer from January 2007 to December 2014 in the province of Ontario, Canada. We included patients who died during the study period and who reported at least one Edmonton Symptom Assessment System (ESAS) score during the last 6months of life. We described the proportion of patients who reported moderate-to-severe symptom scores (≥ 4) by month. Multivariable logistic regression models were created to identify risk factors for moderate-to-severe symptom scores. Seven hundred eighty-eight eligible patients with 3286 unique symptom scores completed during their last 6months of life were identified. The highest prevalence of moderate-to-severe scores was observed for tiredness and lack of appetite, while nausea and depression had the lowest prevalence of elevated scores. The prevalence of moderate-to-severe was consistently high for all symptoms, particularly approaching end-of-life. Timing of ESAS scores, receipt of cancer-directed therapy, urban residence, and female sex were associated with increased odds of reporting moderate-to-severe symptom scores. Patients with metastatic gastric cancer experience significant symptom burden at the end-of-life. Routine screening with patient-reported outcome tools may assist in shared decision-making and effective palliative care by ensuring patients' health status and supportive care needs are identified promptly at the time of clinical encounters.

Symptom assessment in hypereosinophilic syndrome: Toward development of a patient-reported outcomes tool

Symptom assessment in hypereosinophilic syndrome: Toward development of a patient-reported outcomes tool

SUN-349 Characterizing Functional Performance in Adults with Hypophosphatasia

Introduction:Limited data exist regarding physical and cognitive functioning of adults with hypophosphatasia (HPP), and there are no guidelines for evaluation by physical therapists (PT), occupational therapists (OT), or speech-language pathologists (SLP). We evaluated physical and cognitive functioning among adults with HPP through comprehensive assessments and patient reported outcome tools.Methods:Sixteen participants with HPP (median age 42 (32.5–50.5) yrs, 73% female, 100% Caucasian, 50% on enzyme replacement therapy) completed standardized assessments of mobility, balance, fine motor control, activities of daily living and cognition, as well as self-reported measures of health-related quality of life, fatigue, depression and anxiety.Results:Compared with normative data from community dwelling adults, participants traveled less distance on a Six-Minute Walk Test (1,376 ± 431** ft vs 1873±299) and had slower gait on a 10-Meter Walk Test (1.04±0.21 vs 1.39–1.46 m/s). Participants were slower to respond on the Nine Hole Peg Test (20.6±2.4s** for right & 21.7±2.4s** for left hand vs 16.5s to18.5s), and 2 had an abnormally slow reaction time via Dynavision (0.9s* [0.85,0.96], functional speed is <1.15s). 20% scored in the low average/borderline range of performance on the Repeatable Battery for the Assessment of Neuropsychological Status, suggesting potential cognitive impairment. On the Short Form-36, 75% reported limitations in their ability to fulfill life roles due to physical problems (25%±39%ile**), 75% reported below average energy (30%±23ile**), and 100% rated their health as unlikely to improve (32%±15%ile**). Fatigue Severity Scale scores were well above the median for a healthy population (47 [34,60.5]* vs 2.3). Median scores for Depression, Anxiety, and Stress were within the normal range, but moderately severe depression was reported by 4 participants. Participants reported moderate (4), severe (1), or extremely severe (1) anxiety; and 4 reported severe (2) or extremely severe (2) stress.Conclusions:Objective functional assessments indicate mild deficits, but participants self-reported significant limitations due to physical dysfunction, indicating that current objective testing may not be sufficient in the HPP population. Impaired reaction time may indicate potential safety concerns with driving or certain occupations, and screening may be indicated. A subgroup of participants was significantly affected by depression, stress, and/ or anxiety. Guidelines and additional assessment tools should be created to further evaluate physical and cognitive functioning among adults with HPP. The use of PT, OT, and SLP specialists can aid in establishing baseline assessment of impairment and developing treatment plans with objective metrics for assessing efficacy of treatment.*median**mean

PND87 PARKINSON'S DISEASE EXPERIENCE FROM A PATIENT'S PERSPECTIVE: SYSTEMATIC REVIEW ON PATIENT REPORTED OUTCOMES

Parkinson’s disease remains a chronic condition with major unmet needs. Understanding the nature and extent of patient experiences is hampered by a lack of clarity about whether well-developed patient-reported outcomes (PROs) exist or which PRO instrument fits better for Parkinson’s disease. To better inform the selection of PROs that could potentially be used in future clinical trials, the objective was to identify and summarize PRO instruments that have been validated and/or used in the published literature of Parkinson's disease through a systematic literature review. A systematic search of computerized databases PubMed and PsycINFO was conducted between January 2000 and December 2019. Articles were included in the review based on predefined criteria;1)Adults with Parkinson's disease, 2)"Patient-reported” outcome and experience measures;3)Published in English language;4)Sample size >50. The literature screening was conducted by 2 independent reviewers. All of the included studies were assessed for quality. The search yielded a total of 215 articles from 2000 to 2019. The majority of studies are randomized control trials. Overall, we found 16 PROs in the published literature. The patient-reported outcome tool for advanced Parkinson's disease (PRO-APD) evaluates the perceptions of symptom severity and therapy expectations were rated on a Likert scale with score -3 to +3 (very worse to very much improved). Parkinson's disease symptom and severity were evaluated using 39-item Parkinson's Disease Questionnaire (PDQ-39), Freezing of Gait Questionnaire,MDT-PD(Munich Dysphagia Test-Parkinson's Disease), Unified Parkinson Disease Rating Scale. Some studies rated symptom severity on a Likert scale scoring from 0 to 7. The PROs were administered by clinician or patients. We also observed substantial variations in measuring disease symptoms and severity. As FDA’s 21st-century cure act recommends collecting patient experience data during the drug development process, this review systematically summarized patient-reported outcome measures that could be used in future clinical trials and help in understanding patient experience.

Validation of Pediatric Self-Report Patient-Reported Outcomes Measurement Information System (PROMIS) Measures in Different Stages of Legg-Calvé-Perthes Disease.

Patient-reported outcomes (PRO) assessing health-related quality of life (HRQoL) are important outcome measures, especially in Legg-Calvé-Perthes disease (LCPD) where symptoms (pain and limping), activity restrictions, and treatments vary depending on the stage of the disease. The purpose of this study was to investigate the validity of the Patient-reported Outcomes Measurement Information System (PROMIS) for measuring HRQoL of patients with LCPD in various stages of the disease. This is a multicenter validity study. Patients with LCPD between 4 and 18 years old were included and classified into modified Waldenström stages of disease: Early (1 or 2A), Late (2B or 3), or Healed (4). Seven PROMIS domains were collected, including Pain Interference, Fatigue, Mobility, Depression, Anger, Anxiety, and Peer Relationships. Convergent, discriminant, and known group validity was determined. A total of 190 patients were included (mean age: 10.4±3.1 y). All 7 domains showed the worst scores in patients in the Early stage (known group validity). Within each domain, all domains positively correlated to each other (convergent validity). Patients who reported more anxiety, depression, and anger were associated with decreased mobility and increased fatigue and pain. Peer relationships had no to weak associations with other domains (discriminant validity). PROMIS has construct validity in measuring the HRQoL of patients in different stages of LCPD, suggesting that PROMIS has potential to serve as a patient-reported outcome tool for this population. Diagnostic level III study.

PMS70 A SYSTEMATIC REVIEW OF COSTS AND RESOURCE USE ASSOCIATED WITH COMPUTER ASSISTED SURGERY (CAS) FOR TOTAL KNEE ARTHROPLASTY (TKA)

The success and longevity of total knee arthroplasty (TKA) is dependent upon many factors, including accurate alignment of prosthesis and restoration of the mechanical axis of the lower limb. Computer assisted surgery (CAS) could lead to better functional outcomes by enabling more precise component positioning and mechanical alignment versus conventional techniques. A systematic review was conducted to investigate the economic and humanistic burden of CAS compared with conventional methods in patients undergoing TKA. Electronic databases and reference lists were interrogated in February 2019 to identify studies reporting cost/resource use outcomes (including duration of surgery, operating room time, registration time, hospital length of stay [LOS]) and quality of life (QoL)/patient-reported outcome (PRO) data associated with CAS-TKA. Eligible studies were extracted and quality assessed using established methods. A total of 86 relevant studies were identified (cost/resource use, N=55 studies; QoL/PRO, N=63 studies). In general, CAS-TKA was associated with higher upfront technology costs and additional computed tomography (CT) or magnetic resonance imaging (MRI) scans compared with conventional TKA. However, patients undergoing CAS-TKA typically had a shorter hospital LOS (N=9/19 studies) compared with patients undergoing conventional TKA. Few data were reported regarding registration time, operating room time, number of instrument trays required, or indirect costs. Functional outcomes were assessed using a variety of validated PRO tools. CAS was associated with comparable or improved functional outcome compared with conventional surgery over the short- and medium-term, with statistically significant improvements reported with CAS in 9 of 24 studies (follow up time ranged from 6 months to 10 years). Despite higher upfront technology costs, CAS-TKA has been shown to potentially reduce costs through shorter inpatient stays. Further adequately powered studies employing longitudinal data collection with validated tools are certainly warranted to quantify the long-term societal costs and functional outcomes associated with CAS-TKA.

Development of the symptoms and impacts questionnaire for Crohn's disease and ulcerative colitis.

SummaryBackgroundPatient‐reported outcome (PRO) measures historically used in inflammatory bowel disease have been considered inadequate to support future drug labelling claims by regulatory agencies.AimsTo develop PRO tools for use in Crohn's disease (CD) and ulcerative colitis (UC) following guidance issued by the US FDA and the ISPOR (International Society for Pharmacoeconomics and Outcomes Research).MethodsConcept elicitation and cognitive interviews were conducted in adult patients (≥18 years) across the United States and Canada. Semi‐structured interview guides were used to collect data, and interview transcripts were coded and analysed. Concept elicitation results were considered alongside existing literature and clinical expert opinion to identify candidate PRO items. Cognitive interviews evaluated concept relevance, interpretability and structure, and facilitated instrument refinement. Concept elicitation participants, except those with an ostomy, underwent centrally read endoscopy to assess inflammatory status.ResultsIn all, 54 participants (mean age: 46.2 years; 66.7% female) were included in the CD concept elicitation interviews. In total, 80 symptom concepts and 61 impact concepts were identified. After three waves of cognitive interviews, the 31‐item Symptoms and Impacts Questionnaire for CD (SIQ‐CD) was developed. In the UC concept elicitation phase, 53 participants were interviewed (mean age: 41.4 years; 49.1% female). In total, 79 symptoms concepts and 49 impact concepts were identified. Following two waves of cognitive interviews, the 29‐item Symptoms and Impacts Questionnaire for UC (SIQ‐UC) was developed. Both instruments include four symptom and six impact domains.ConclusionsWe developed PROs to support CD and UC drug labelling claims. Psychometric validation studies to evaluate instrument reliability and responsiveness are ongoing.

Comparison of pediatric sports fracture outcomes based on provider type

ABSTRACT Objective: Pediatric primary care sports medicine physicians and pediatric sports medicine orthopedic surgeons, in conjunction with physician assistants (PAs), often manage patients with fractures. We sought to determine if pediatric patients with fractures seen by primary care sports medicine physicians had similar outcomes and satisfaction as those seen by orthopedic surgeons. Methods: We performed a retrospective chart review of four to 18-year-old patients who were treated by a sports medicine provider (primary care or orthopedic surgeon/PA) for a fracture of the radius, ulna, tibia, or fibula. Patients or their parents completed a patient satisfaction survey (Short Assessment of Patient Satisfaction [SAPS]) and an injury location-specific patient-reported functional outcome tool: the Foot and Ankle Ability Measure (FAAM) or the Disabilities of the Arm, Shoulder, and Hand (DASH) Scale. Results: Fifty-seven (70%) of the 82 patients were treated by pediatric primary care sports medicine physicians and 25 (30%) were treated by a pediatric sports medicine orthopedic surgeon or surgical PA. The median time from injury to clinically confirmed healing was similar between the two groups (47 vs 60.5 days; p = 0.54), as was the patient satisfaction (SAPS median score = 26 [range = 19–28] vs 24 [range = 9–28]; p = 0.12). Patient-reported outcomes did not differ significantly between groups for the functional outcome tools. Conclusions: Patients seen by pediatric primary care sports medicine physicians and sports medicine orthopedic surgeons have similar patient-reported fracture outcomes and similar satisfaction with care. Pediatric patients with fractures will likely have favorable outcomes when cared for by either of these subspecialty providers.

Long-term patient-reported distress in locally advanced cervical cancer patients treated with definitive chemoradiation

Background and purposeTo evaluate longitudinal patient-reported distress in cervical cancer patients treated with definitive chemoradiation (CRT). Materials and methodsBetween 2011 and 2016, consenting cervical cancer patients treated with definitive CRT who completed ≥ 2 revised Edmonton Symptom Assessment System (ESAS-r) questionnaires at clinical visits, including baseline, were included. A linear mixed model was used to assess the longitudinal trend in ESAS-r. A minimal clinically important difference (MCID) for total ESAS-r score was defined as a change of 3-points for improvement and 4-points for deterioration. The proportion of patients with an MCID over time was described using moving averages. To test for changes, mixed effects logistic models were fitted, each of which included patient-specific random intercepts and random slopes. Results67 patients were eligible for analysis (736 ESAS-r assessments). Median (range) follow-up was 24 months (range: 15–45) and compliance at 12 months was 60% (40/67). There was a significant decrease in ESAS-r scores over time. Baseline ESAS-r was strongly predictive of ESAS-r at follow-up (p < 0.001). The proportion of patients with an MCID for improvement from baseline significantly increased over time (p < 0.001) and the proportion with an MCID for deterioration significantly decreased over time (p < 0.001). No predictors for distress were found. ConclusionsLong-term cervical cancer survivors experience distress that significantly improves over time to an extent expected to be clinically meaningful for patients. Implementing cervical cancer specific patient-reported outcome tools into practice could better inform patient needs.

Percentile curves for the knee injury and osteoarthritis outcome score in the middle-aged dutch population

Purpose: The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire is a widely used patient-reported outcome tool, developed to evaluate short- and long-term knee symptoms and function. Previous studies evaluating knee complaints in the general population have shown that individuals in the general population do not report the best possible score on knee-specific questionnaires, stressing the need for benchmarks for adequate interpretation of these patient-reported scores. Therefore, we aimed to improve the interpretation of the KOOS by developing reference curves in a large population-based cohort.

Abstract 158: Satisfaction With Appearance In Patients With Cleft Lip And/or Palate: Patient-reported Outcomes Using The Cleft-q At The University Of Pittsburgh

Purpose: To date, surgical outcomes after cleft lip and/or palate (CL/P) surgery have been largely determined by the assessment of surgeons or bystanders, underestimating what might matter to patients. The CLEFT-Q is a new, validated patient-reported outcome (PRO) instrument that evaluates patient satisfaction and QOL in children and adolescents with CL/P through different life domains. Our aim was to evaluate the satisfaction of patients with CL/P with their own appearance, using the CLEFT-Q as a metric. Methods: Patients 8-29 years with a diagnosis of CL/P visiting our institution’s craniofacial center from 2015-2016 were included during the phase II stage of the CLEFT-Q multicenter validation. The CLEFT-Q questionnaire was administered during the visit, ensuring it was filled with no parental interference. Only the appearance domain was used, including questions on face, nose, nostrils, lips, cleft scar, teeth and jaws. Rasch-transformed scores were analyzed using one-way ANOVAS to detect significant main effects and interactions between groups (p<0.05, two-tailed) with Fisher posthoc tests. Results: 101 patients (female n=53; male n=48) were included, with diagnoses including the common range of CL/P deformities (CL, CP, CL+P, CL+A, and BL CL+P). The majority (55%) were aged 8-11; 37.6% between 12-17; and 6.9% aged 18 or older. Nose and nostril scores were the lowest of appearance satisfaction scores in patients whose deformity included CL. Patients with CP had a significantly higher nose and nostril scores compared to CL, CL+P, CL+A, and BL CL+P (p=0.003, 0.000, 0.029, and 0.039, respectively). Lip or cleft scar scores were not significantly different between any groups. While scores for nose appearance satisfaction did not vary significantly between age groups in males, scores trended lower with increasing age in females (p=0.012). The same was seen in nostril scores (p=0.038), and trended for significance in lip scores (0.054). Satisfaction was lower in the 12-17 years category. Females in the 18+ age group scored lower than males across all appearance items. Conclusion: PRO tools are essential to understand what patients value to better guide surgical decisions. Adolescents are particularly vulnerable in terms of satisfaction with their appearance, which could warrant closer follow up. Nasal aesthetics are a particularly concerning feature to patients with any type of CL. The lower satisfaction rates with increasing age in females should be addressed, and may warrant additional attention to cosmetic details when reaching adulthood.

Translation, validation and test-retest reliability of the VISA-G patient-reported outcome tool into Danish (VISA-G.DK).

The Victorian Institute of Sport Assessment (VISA) questionnaire model is based on item response theory using a graded response (responses reflect increasing difficulty). The purpose of the VISA-G is to monitor patient outcomes and evaluate treatment strategies for people with greater trochanteric pain syndrome (GTPS). The primary aim of the current study was to translate and culturally adapt the VISA-G into a Danish context (DK) through forward and back translation and cognitive interviews. The second aim was to establish test–retest reliability and face validity of the VISA-G into a Danish context (DK). No major disagreements were observed between the original and translated versions of the questionnaire. A total of 58 heterogenous asymptomatic, and 49 symptomatic respondents (response rate: 92% and 78% respectively) completed the VISA-G.DK twice, 1 week apart. The VISA-G.DK had excellent internal consistency (Cronbach’s alpha: asymptomatic = 0.86; symptomatic = 0.98). The test–retest reliability was excellent for the total score: ICC: 0.961 (95% CI [0.933–0.978]). Standard Error Measurement was calculated to be 0.6. Bland–Altman plots showed no significant or relevant differences from test to retest in the total score with mean differences below 1 (0.61). The minimal detectable change was 3.17 for both groups. The VISA-G.DK was found to be valid, reliable and acceptable for use in the Danish population.

Systematic Review of Patient-Reported Outcomes following Surgical Treatment of Lymphedema.

Introduction: Analysis of quality of life (QOL) outcomes is an important aspect of lymphedema treatment since this disease can substantially impact QOL in affected individuals. There are a growing number of studies reporting patient-reported outcomes (PROMs) for patients with lymphedema. The purpose of this study was to conduct a systematic review of outcomes and utilization of PROMs following surgical treatment of lymphedema. Methods: A literature search of four databases was performed up to and including March, 2019. Studies included reported on QOL outcomes after physiologic procedures, defined as either lymphovenous bypass (LVB) or vascularized lymph node transplant (VLNT), to treat upper and/or lower extremity primary or secondary lymphedema. Results: In total, 850 studies were screened—of which, 32 studies were included in this review. Lymphovenous bypass was the surgical intervention in 16 studies, VLNT in 11 studies, and both in 5 studies. Of the 32 total studies, 16 used validated survey tools. The most commonly used PROM was the lymph quality of life measure for limb lymphedema (LYMQOL) (12 studies). In the remaining four studies, the upper limb lymphedema 27 scale (ULL27), the short form 36 questionnaire (SF-36), the lymphedema functioning, disability and health questionnaire (Lymph-ICF), and lymphedema life impact scale (LLIS) were each used once. QOL improvement following surgical treatment was noted in all studies. Conclusions: Physiologic surgical treatment of lymphedema results in improved QOL outcomes in most patients. The use of validated PROM tools is increasing but there is no current consensus on use. Future research to evaluate the psychometric properties of PROMs in lymphedema is needed to guide the development and use of lymphedema-specific tools.

Anxiety patient reported outcome tool (GAD-7) use in complementary medicine teaching clinics throughout Australia

ObjectiveTo assess how the introduction of the Generalized Anxiety Disorder-7 (GAD-7) was utilised in consultations by students in complementary medicine undergraduate teaching clinic throughout Australia. This study also aims to evaluate the reported severity of anxiety in patients attending the clinic, the practitioner type consulted, and the treatment prescribed by the Complementary Medicine (CM) students for patients with anxiety during 2017-18. DesignThis is a longitudinal, observational study using data from the Endeavour Wellnation clinics across Australia. MethodsPatients anxiety levels were measured with the GAD-7 at consultations with student practitioners during 2017–2018. Patients that completed the GAD-7 more than once had their subsequent GAD-7 scores compared to assess changes in outcome score. Information was taken from SurveyGizmo for patients who visited the student clinic making it a sub-group analysis. ResultsThree hundred and ninety (n = 390) GAD-7 surveys were completed from the 50, 896 consultations that occurred in 2017 and 2018 (0.7 % of consultations). Most patients (29.7 %, n = 116) reported moderate anxiety on several days. Thirty-nine patients (n = 39) completed the GAD-7 more than once. Nutrition patients were the most frequent to complete the GAD-7 more than once. ConclusionsThe introduction of the GAD-7 at Australian complementary medicine teaching clinics reported usage frequency of 0.7 % of consultations in the first two years. The reason for this usage frequency may be due to low encouragement of the use of Patient Reported Outcome Measurements (PROMs) by clinic supervisors and in pre-clinic subjects, students having low confidence in the use of the GAD-7 or other PROMs or lack of understanding of their benefits by either the student practitioner or the client. The lack of subsequent GAD-7 use in follow-up consultations may be contributing to a decreased substantiation of treatment outcomes for both the patient and the students. Consideration of more frequent use of the GAD-7 in regular clinical practice to enhance clinical outcomes and practitioner education is warranted.

Instruments for Screening, Diagnosis, and Management of Patients with Generalized Acquired Hypoactive Sexual Desire Disorder.

Screening, diagnosis, and management of hypoactive sexual desire disorder (HSDD) and research into the condition have been challenging due to its biopsychosocial complexity and lack of consensus on relevant measures. Although physician interviews yield much clinically valid information, self-reported questionnaires appear more acceptable to patients and physicians. Consequently, validated patient-reported outcome (PRO) tools are essential for evaluation and management of HSDD, including any therapeutic intervention. The US Food and Drug Administration (FDA) has issued guidance on the use of appropriate endpoints and associated measures for female sexual dysfunction, including HSDD. Although many of the available measures were not designed specifically for HSDD assessment, as per FDA guidelines, most clinical studies have used individual domains or items from established tools, such as the Female Sexual Function Index-desire domain and Item 13 of the revised Female Sexual Distress Scale. For clinical practice, several professional societies recommend the Decreased Sexual Desire Screener and/or a sexual history as tools to diagnose HSDD. This review discusses frequently used PRO tools as well as the newly developed and validated Elements of Desire Questionnaire, which may be appropriate for clinical trials or clinical practice.