Patient-reported Questionnaires Research Articles

Two-step screening for depressive symptoms in patients treated with kidney replacement therapies: a cross-sectional analysis.

Systematic screening for depressive symptoms may identify patients who may benefit from clinical assessment and psychosocial support. Here we assess a two-step screening using ultrabrief pre-screeners [Edmonton Symptom Assessment Survey-revised Depression item (ESASr-D) or Patient Health Questionnaire-2 (PHQ-2)] followed by the Patient-Reported Outcomes Measurement Information System Depression questionnaire (PROMIS-D) to identify depressive symptoms in patients on kidney replacement therapies. We conducted a cross-sectional study of adults (kidney transplant recipients or treated with dialysis) in Toronto, ON, Canada. We simulated various two-step screening scenarios where only patients above a pre-screening cut-off score on the ESASr-D or PHQ-2 would move to step 2 (PROMIS-D). Screening performance was evaluated by sensitivity, specificity and positive and negative predictive values using the Patient Health Questionnaire-9 (PHQ-9) as the referent. The average number of items completed by patients in different scenarios was reported. Of 480 participants, 60% were male with a mean age of 55years. Based on PHQ-9, 19% of patients had moderate or severe depressive symptoms. Pre-screening with a PHQ-2 score ≥1 combined with a PROMIS-D score of ≥53 provided the best two-step results (sensitivity 0.81, specificity 0.84, NPV 0.95). Two-step screening also reduces question burden. A two-step screening using a PHQ-2 score ≥1 followed by a PROMIS-D score ≥53 has good sensitivity and specificity for identifying potentially significant depressive symptoms among patients on kidney replacement therapies. This approach has lower question burden. Screened-in patients will need further clinical assessment to establish a diagnosis.

Clinical outcomes of shoulder arthroplasty for post-instability arthropathy after open anterior bone block stabilization

BackgroundPost-instability glenohumeral arthropathy can occur after nonanatomic instability repairs. With advanced secondary arthritis, subsequent shoulder arthroplasty may be complicated by altered surgical anatomy, poor range of motion, subscapularis deficiency, unique glenoid wear patterns, and/or aberrant neurovascular anatomy. The purpose of this study was to evaluate the clinical outcomes of patients undergoing shoulder arthroplasty after previous open nonanatomic anterior shoulder stabilization, particularly glenoid bone block procedures. MethodsBetween 2008 and 2014, all patients with shoulder arthroplasty for symptomatic post-instability glenohumeral arthropathy after prior open stabilizations were identified from surgical case logs of two senior shoulder surgeons. Demographic variables were extracted from electronic medical records, operative reports, and preoperative and postoperative radiographs, and a minimum 24-month follow-up with completion of patient-reported questionnaires was required. Postoperative active forward elevation and active external rotation were recorded. The primary outcome measures were the visual analog scale for pain, American Shoulder and Elbow Surgeons Shoulder score, and the Simple Shoulder Test. Perioperative complications and rates of secondary reoperation were extracted. ResultsA total of 12 patients were identified with an average age of 63 ± 12 years (range, 46-83), including 7 males and 5 females, and index surgery included open Bristow (n = 7), open Latarjet (n = 2), iliac crest bone graft (n = 1), and Putti-Platt procedure (n = 2). Seven patients underwent anatomic TSA, 4 reverse TSA, and 1 hemiarthroplasty. At an average of 44 ± 21 months follow-up, average active forward elevation and active external rotation improved from 100 ± 36 preoperatively to 132 ± 41 (P = .12) postoperatively and 19 ± 15 to 49 ± 11 (P < .01), respectively. The average visual analog scale decreased from 5 ± 3 to 1 ± 2 (P < .01) and mean American Shoulder and Elbow Surgeons improved from 44 ± 23 to 79 ± 17 (P < .01); and the average Simple Shoulder Test improved from 4 ± 2 to 9 ± 3 (P < .01). No perioperative complications or secondary reoperations were required, and only one patient experienced subsequent instability due to subsequent shoulder trauma. ConclusionDespite the surgical complexity and unique challenges associated with post-instability arthropathy, shoulder arthroplasty after prior open anterior bone block procedure or nonanatomic reconstruction is a safe procedure with low risk of perioperative complication, subsequent shoulder instability, or secondary revision surgery. All patients experienced significant improvements in pain, range of motion, and self-reported function at short- to mid-term follow-up.

34679 Association of adult atopic dermatitis severity with decreased physical activity: A cross-sectional study

In multivariable logistic regression models controlling for age, sex, race/ethnicity and asthma history, patient-reported global AD severity, Patient-Oriented Eczema Measure (POEM), Eczema Area and Severity Index (EASI), and Investigator’s Global Assessment (IGA) were associated with itch impairing light, moderate and vigorous physical activity, and higher Patient-Reported Outcome Measurement Information System Itch Questionnaire Physical Activity T-scores. Higher objective Scoring AD (O-SCORAD) was associated with itch impairing moderate physical activity. In bivariable analyses, odds of performing ≥30 minutes of light physical activity ≥1 day a week were lower with increased patient-reported AD severity, POEM, and EASI scores; ≥30 minutes of moderate physical activity ≥1 day a week were lower with increased patient-reported AD severity, EASI, O-SCORAD, and IGA; ≥30 minutes of vigorous physical activity were lower with increased patient-reported AD severity, EASI, O-SCORAD, and IGA scores. In multivariable logistic regression models, increased impact of itch on physical activity was associated with lower odds of performing light, moderate, and vigorous physical activity.

33008 Improving clinical trial experience for patients and investigators through a simulated trial in palmoplantar pustulosis (PPP)

Clinical trial participation can be challenging for patients and investigators. Understanding the main challenges and, therefore, opportunities for improvement through a simulated trial has the potential to enhance future trial designs and outcomes. A phase 3 clinical trial of patients with PPP was simulated in 3 stages: (i) at-home assignments, involving review of trial materials and completion of patient-reported outcome questionnaires; (ii) virtual trial visits, involving conversations between patients and physicians; and (iii) virtual debrief interviews for both patients and physicians.

Preoperative Patient-Reported Data Indicate the Risk of Prolonged Opioid Use After Hand and Upper Extremity Surgeries

Opioids play an important role in pain management after surgery but also increase the risk of prolonged opioid use in patients. The identification of patients who are more likely to use opioids after intended short-term treatment is critical for employing alternative management approaches or targeted interventions for the prevention of opioid-related problems. We used patient-reported data (PRD) and electronic health record information to identify factors predictive of prolonged opioid use after surgery. We used our institutional registry containing data on all patients who underwent elective upper extremity surgeries. We evaluated factors associated with prolonged opioid use in the cohort from the year 2018 to 2019. We then validated our results using the 2020 cohort. The predictive variables included preoperative PRD and electronic health record data. Opioid use was determined based on patient reports and/or filled opioid prescriptions 3 months after surgery. We conducted bivariate regression, followed by multivariable regression analyses, and model validation using area under the receiver operating curve. We included 2,114 patients. In our final model on the 2018-2019 electronic health records and PRD data (n= 1,589), including numerous patient-reported outcome questionnaire scores, patients who were underweight and had undergone trauma-related surgery had higher odds of being on opioids at 3 months. Additionally, each 5-unit decrease in the preoperative Patient-Reported Outcomes Measurement Information System Global Physical Health score was associated with a 30% increased odds of being on opioids at 3 months. The area under the receiver operating curve of our model was 70.4%. On validation using data from the 2020 cohort, the area under the receiver operating curve was 60.3%. The Hosmer-Lemeshow test indicated a good fit. We found that preoperative questionnaire scores were associated with prolonged postoperative opioid use, independent of other variables. Furthermore, PRD may provide unique patient-level insights, alongside other factors, to improve our understanding of postsurgical pain management. Prognostic II.

Experiences of patients with poststroke spasticity throughout a botulinum toxin treatment cycle: Results from a prospective ethnographic study.

This study was conducted to capture the experience of patients with poststroke spasticity (PSS) throughout one botulinum neurotoxin A (BoNT-A) treatment cycle. The REBOT study (NCT03995524) was a prospective, observational ethnographic study conducted in France, Italy, the UK, and the USA. It combined a mixed-method ethnography (including semi-structured qualitative interviews within a week of a BoNT-A injection) with completion of a longitudinal quantitative patient-reported outcome questionnaire and sharing of video and images, both reported weekly over a 12–14-week period throughout the BoNT-A treatment cycle. The study recruited 30 adult patients with PSS who were receiving BoNT-A treatment. The most commonly used BoNT-A product was onabotulinumtoxinA (Botox®), which was administered to 21 patients (70%), whereas two patients (6.7%) received abobotulinumtoxinA (Dysport®) and seven patients (23.3%) did not specify the BoNT-A medication that they received. Patients reported a high, continuous burden of PSS, with spasms, sleeping difficulties, stiffness, and pain being the most commonly reported symptoms. In line with an observed waning effect of BoNT-A injections, spasticity symptoms initially were improved at Weeks 4–6 after injection but reemerged after 9–11 weeks. Treatment satisfaction levels decreased over the BoNT-A treatment cycle, as reflected by the worsening of symptoms and the need to self-medicate and consult a physician. The psychological impact of PSS was high. Patients acknowledged the benefits of BoNT-A treatment but wished for more individualized treatment plans with flexible dosing and injection intervals. Additionally, only 10% of patients reported that they had a trusting relationship with their physician and believed that their needs were considered by those managing their PSS. To our knowledge, this was the first ethnographic study in patients with PSS who were treated with BoNT-A. This ethnographic approach to patient surveys complements traditional research methods and allows improved identification of patients' unmet needs by capturing their weekly experience of treatment. The findings of this study confirm previous observations of the diminishing effectiveness of BoNT-A injections between treatment sessions, highlighting the need for agents with a longer duration of action and/or a more flexible treatment pattern that allows for more frequent injections.

1034 Radiological Outcomes Following Surgery for Developmental Dysplasia of the Hip

Abstract Aim Developmental dysplasia of the hip (DDH) is a condition affecting newborns, in which abnormal acetabulum development can result in femoral head subluxation or dislocation. This study aims to retrospectively evaluate radiological outcomes of patients with DDH, treated by either closed reduction, open reduction, or open reduction with osteotomy. Method This study included 59 hips of 54 patients with a median age of 19.6 months at the time of surgery. Radiographs were assessed for the International Hip Dysplasia Institute (IHDI) grade of dislocation, acetabular index (AI), centre-edge angle (CEA), Severin classification and avascular necrosis (AVN). Results Median duration of follow up between primary operation and latest available radiograph was 4.9 years. Pre-operatively, 41 hips were IHDI Grade IV, 16 hips were Grade III and two hips were Grade II. Mean pre-operative AI was 37.9°, which decreased to 22.7° at the latest follow up. Mean CEA was 22.9°. 25 hips were found to be Severin class I, eight hips were class II and three hips were class III. Four hips developed Group II AVN and one hip developed Group III. Nine hips required further surgery. Conclusions The study found overall favourable radiological outcomes of treatment of DDH, with minimal differences between each operation. Longer follow up is needed to evaluate time-dependent outcomes such as Severin class and AVN. A patient-reported outcome questionnaire is necessary to provide information on the correlation of radiological outcomes and physical function.

Self-Reported Measures of Periodontitis in a Portuguese Population: A Validation Study.

Self-reported questionnaires have been developed and validated in multiple populations as useful tools to estimate the prevalence of periodontitis in epidemiological settings. This study aimed to explore the accuracy of self-reporting for predicting the prevalence of periodontitis in a Portuguese population. The questionnaires were given to patients at a university clinic. Thirteen self-reported questions on periodontal health were gathered in a patient-reported questionnaire. Then, self-reporting responses were validated using full-mouth periodontal examination as a comparison. Multivariable logistic regression was used to analyze sensitivity, specificity, accuracy, precision, and area under the curve-receiver operator characteristic (AUC-ROC). Self-reported answers from 103 participants (58 females and 45 males) were included. Self-reported gum health, loose teeth, tooth appearance, and use of dental floss were associated with different definitions of severe periodontitis. The self-reported questions on “having gum disease,” combined with “having gum treatment” and “having lost bone” were the items with higher performance for the 2018 case definition and the 2012 case definition, as well as for each respective severity staging. Categorization of tooth loss was only valuable for the prediction of periodontitis cases according to the 2012 case definition and its severe stage. Multiple self-reporting set-ups showed elevated performance levels for predicting periodontitis in Portuguese patients. These results may pave the way for future epidemiological surveillance programs using self-reporting approaches.

Association of Adult Atopic Dermatitis Severity With Decreased Physical Activity: A Cross-sectional Study.

Background: Atopic dermatitis (AD) is associated with chronic pruritus, skin pain, sleep deprivation, depression, and anxiety, which may lead to decreased physical activity (PA). Objective: The aim of the study is to elucidate the impact of disease and itch severity on PA in adult AD. Methods: This is a prospective dermatology practice-based study of 955 AD patients (ages 18-97 years). Results: In multivariable logistic regression models controlling for age, sex, race/ethnicity, and asthma history, patient-reported global AD severity (PtGA), Patient-Oriented Eczema Measure, Eczema Area and Severity Index (EASI), and Investigator's Global Assessment (IGA) were associated with itch impairing light PA, moderate PA, and vigorous PA, as well as higher Patient-Reported Outcomes Measurement Information System Itch Questionnaire PA T-scores. Higher objective Scoring AD (O-SCORAD) was associated with itch impairing moderate PA. In bivariable analyses, performing greater than or equal to 30 minutes of light PA greater than or equal to 1 day a week was decreased with higher PtGA, Patient-Oriented Eczema Measure, and EASI; greater than or equal to 30 minutes of moderate PA greater than or equal to 1 day a week was decreased with PtGA, EASI, O-SCORAD, and IGA; and greater than equal to 30 minutes of vigorous PA was decreased with patient-reported AD severity, EASI, O-SCORAD, and IGA. In multivariable logistic regression models, the impact of itch on PA was inversely associated with light PA, moderate PA, and vigorous PA. Conclusion: Adult AD patients with more severe disease have decreased levels of PA secondary to itch.

First Experience and Prospective Evaluation on Feasibility and Acute Toxicity of Online Adaptive Radiotherapy of the Prostate Bed as Salvage Treatment in Patients with Biochemically Recurrent Prostate Cancer on a 1.5T MR-Linac.

Introduction: Novel MRI-linear accelerator hybrids (MR-Linacs, MRL) promise an optimization of radiotherapy (RT) through daily MRI imaging with enhanced soft tissue contrast and plan adaptation on the anatomy of the day. These features might potentially improve salvage RT of prostate cancer (SRT), where the clinical target volume is confined by the mobile organs at risk (OAR) rectum and bladder. So far, no data exist about the feasibility of the MRL technology for SRT. In this study, we prospectively examined patients treated with SRT on a 1.5 T MRL and report on workflow, feasibility and acute toxicity. Patients and Methods: Sixteen patients were prospectively enrolled within the MRL-01 study (NCT: NCT04172753). All patients were staged and had an indication for SRT after radical prostatectomy according to national guidelines. RT consisted of 66 Gy in 33 fractions or 66.5/70 Gy in 35 fractions in case of a defined high-risk region. On the 1.5 T MRL, daily plan adaption was performed using one of two workflows: adapt to shape (ATS, using contour adaptation and replanning) or adapt to position (ATP, rigid replanning onto the online anatomy with virtual couch shift). Duration of treatment steps, choice of workflow and treatment failure were recorded for each fraction of each patient. Patient-reported questionnaires about patient comfort were evaluated as well as extensive reporting of acute toxicity (patient reported and clinician scored). Results: A total of 524/554 (94.6%) of fractions were successfully treated on the MRL. No patient-sided treatment failures occurred. In total, ATP was chosen in 45.7% and ATS in 54.3% of fractions. In eight cases, ATP was performed on top of the initial ATS workflow. Mean (range) duration of all fractions (on-table time until end of treatment) was 25.1 (17.6–44.8) minutes. Mean duration of the ATP workflow was 20.60 (17.6–25.2) minutes and of the ATS workflow 31.3 (28.2–34.1) minutes. Patient-reported treatment experience questionnaires revealed high rates of tolerability of the treatment procedure. Acute toxicity (RTOG, CTC as well as patient-reported CTC, IPSS and ICIQ) during RT and 3 months after was mild to moderate with a tendency of recovery to baseline levels at 3 months post RT. No G3+ toxicity was scored for any item. Conclusions: In this first report on SRT of prostate cancer patients on a 1.5 T MRL, we could demonstrate the feasibility of both available workflows. Daily MR-guided adaptive SRT of mean 25.1 min per fraction was well tolerated in this pretreated collective, and we report low rates of acute toxicity for this treatment. This study suggests that SRT on a 1.5 T MRL can be performed in clinical routine and it serves as a benchmark for future analyses.

Creation of a tool to evaluate supportive care.

The absence of a specific tool to evaluate the impact of supportive care in general and socioesthetics (SE) in particular is undoubtedly at the origin of the lack of published research based on scientific standards. We developed a supportive-care, patient-reported outcome questionnaire using the multistep methods, following COSMIN recommendations. The Patient Centricity Questionnaire (PCQ) was developed using the standardized methodology for designing patient-reported outcome (PRO) questionnaires according to the following steps: elaboration of the questionnaire, measurement properties of the questionnaire, internal and external validation, test-retest validation and translation, cross-cultural adaptation, and cognitive debriefing. A multidisciplinary work group was designed including professionals, such as physicians, public health experts, sociologists, supportive-care experts, and socioestheticians. Our questionnaire includes 11 items. It is scored by adding each Visual Analogue Scale [VAS], making it range from 0 to 110, with a higher benefit when the score is higher. The Cronbach's α coefficient is 0.88 for the entire questionnaire. As the questionnaire is a reflection of the patient's feelings, it is quite natural that the name "Patient Centricity Questionnaire" (PCQ) was retained and validated by the Scientific Committee. The PCQ correlated negatively and moderately with the Perceived Stress Scale [PSS], positively and moderately with the mental dimension of the Short Form-12, and poorly with the Well Beng 12 [WB12], the physical dimension of the SF-12, and the satisfaction VAS. Constructed according to the recommendations, the PCQ meets the prerequisite for this type of questionnaire. Its short format and simplicity of use allow it to be used by a large number of people. The PCQ is a simple, reliable, easy-to-use, and validated tool for research teams, making it possible for randomized studies to prove the impact of supportive care in general and SE in particular, on the patient's quality of life.

Complex Nasal Reconstruction in a Wide-awake Ambulatory Setting: A Study of Efficacy and Perioperative Patient Experience

Background:The use of local anesthesia in nasal surgery has gained popularity as a cost-effective and safe alternative. With the potential benefit of reconstruction without using general anesthesia, the goal of the study was to evaluate the patient-reported experience in addition to surgical outcomes and perioperative complications.Methods:A mixed-methods study was completed with retrospective chart review and patient-reported outcome questionnaire. The primary outcome measures were demographics, oncologic and surgical details, and postoperative complications. Secondary outcome measures were aesthetic outcomes and procedure tolerance, which were gathered from the FACE-Q questionnaire.Results:Of the 22 patients who met inclusion criteria, nine patients (41%) had forehead flaps performed and 13 patients (59%) had multilayer reconstruction with local flaps and cartilage grafts. The average number of surgeries performed, including revisions, was 2.3 ± 0.2. The overall complication rate for reconstructions and revisions was 20%, most of these were minor complications. The overall subjective rating of patient’s appearance was excellent with an average score of 83.9 (± 17.3) out of 100. There was minimal appearance distress as a product of the surgery with an average score of 84.9 (±18.8). On a scale of one to five, patients reported an average of 4.3 for convenience, 3.8 for efficiency of setup and procedure, and 3.4 out of 5 for comfortability with having an operation performed on their face wide awake.Conclusion:Our study demonstrated that complex nasal reconstruction performed under local anesthetic in a minor procedure setting is a feasible and safe option with good patient-reported outcomes.

Rhoads Research Lecture-Reflections from a clinician scientist: The power of patient voice.

Qualitative research is a scientific method that systematically examines a phenomenon with the purpose of understanding and describing human experiences, exploring meanings and patterns, and illuminating the patient's lived experience. The Rhoads Research Lecture will highlight the power of patient voice and its importance to clinicians and researchers in addressing key clinical needs that are most relevant to patients receiving nutrition support. The subjective experience of patients who are dependent on home parenteral nutrition (HPN) will be shared, including how patients view HPN, define their quality of life (QOL), and describe the meaning of food in the context of being intravenously fed. As a result of these exploratory studies, the HPN patient-reported outcome questionnaire (HPN-PROQ) was developed and validated. Incorporating the HPN-PROQ in practice empowers patients to identify and communicate QOL and HPN therapy goals and clinicians to delve deeper in the provision of holistic and empathetic care.

Developing and Implementing ICF-Based Tools for Occupational Rehabilitation Supporting the Communication and Return to Work Process Between Sickness Absentees, Clinical Team and Jobcentre Contacts.

BackgroundThe ICF model is applied as a conceptual framework in occupational rehabilitation in Norway.ObjectiveTo systematically apply the ICF model in rehabilitation this study had the following aims: (1) apply an ICF subset by merging an ICF core set and an ICF set to assess functioning in rehabilitation patients related to work; (2) develop a patient-reported ICF questionnaire and a clinician-friendly ICF report complementing the clinician-rated ICF subset and (3) evaluate whether ICF-based tools (subset, questionnaire, report) support the communication between a clinical team, patient and jobcentre contacts during return to work (RTW) follow up.MethodsForty-one patients completing four weeks rehabilitation were recruited. The patients were referred from general practitioners and jobcentres. The ICF subset was a combination of the EUMASS core set for disability evaluation and suggested ICF categories by experts in vocational rehabilitation from Iceland. A clinical rehabilitation team interviewed the patients using the ICF subset and problems were quantified on a generic qualifier scale for body functions, activities and participation and environmental factors. The research team and clinical team developed an ICF questionnaire, by cross-culturally adapting the Work Rehabilitation Questionnaire to Norwegian. The same teams also developed an ICF report. The rehabilitation clinic forwarded the report and questionnaire to the patients' jobcentre contact, which was responsible for the RTW follow up. To evaluate the benefits of ICF-based tools, the clinical team, user representative and jobcentre contacts together participated in four workshops. They were asked the degree to which and in what way the tools supported the communication between them.ResultsThe ICF subset captured RTW challenges but was found to be time consuming. The jobcentres experienced the ICF report and questionnaire beneficial in the follow up as it strengthened their RTW decision-making basis and communication with the rehabilitation clinic and the patients about follow-up interventions.ConclusionThe development and implementation of ICF-based tools for clinical practice was a preliminary success in supporting the communication between three stakeholders during RTW follow up. Future applications of ICF-based tools ought to integrate personal factors to capture both facilitators and barriers related to functioning and work, thus, getting closer to a holistic assessment.

Post-Laryngectomy Voice Prosthesis Changes by Speech-Language Pathologists: Preliminary Results.

Background: In the present study, we assess the feasibility and success outcomes of voice prosthesis (VP) changes when performed by a speech-language pathologist (SLP). Methods: Patients treated with total laryngectomy (TL) from January 2020 to December 2020 were prospectively recruited from our medical center. Patients benefited from tracheoesophageal puncture. The VP changes were performed by the senior SLP and the following data were collected for each VP change: date of placement; change or removal; VP type and size; reason for change or removal; and use of a washer for periprosthetic leakage. A patient-reported outcome questionnaire including six items was proposed to patients at each VP change. Items were assessed with a 10-point Likert-scale. Results: Fifty-two VP changes were performed by the senior SLP during the study period. The mean duration of the SLP consultation, including patient history, examination and VP change procedure, was 20 min (range: 15–30). The median prosthesis lifetime was 88 days. The main reasons for VP changes were transprosthetic (n = 34; 79%) and periprosthetic (n = 7; 21%) leakages. SLP successfully performed all VP changes. He did not change one VP, but used a periprosthetic silastic to stop the periprosthetic leakages. In two cases, SLP needed the surgeon’s examination to discuss the following indication: implant mucosa inclusion and autologous fat injection. The patient satisfaction was high according to the speed and the quality of care by the SLP. Conclusions: The delegation of VP change from the otolaryngologist–head and neck surgeon to the speech-language pathologist (SLP) may be achieved without significant complications. The delegation of VP change procedure to SLP may be interesting in some rural regions with otolaryngologist shortages.

Association of psychological factors with limb disability in patients with cervical radiculopathy: comparison with carpal tunnel syndrome

BackgroundRegarding musculoskeletal conditions, patient’s psychological distress, are shown to be associated with higher disability. Cervical radiculopathy (CR) and carpal tunnel syndrome (CTS), are two conditions caused by entrapment of cervical nerve roots and carpal median nerve, respectively. This study aims to investigate the association of psychological factors including depression, anxiety, and pain catastrophizing, with measures of upper limb patient-reported and performance-based disability, in patients with CR, and compare the obtained results with our similar study on CTS.MethodsIn a cross-sectional study, we recruited 92 patients with CR, and investigated their disability level using patient-reported questionnaires (Quick Disabilities of the Arm, Shoulder and Hand (DASH) and pain Likert Scale) and by measuring grip and pinch strength. We also assessed their psychological status with Hospital Anxiety and Depression Scale questionnaire for depression (HADS-D) and anxiety (HADS-A) and also Pain Catastrophizing Scale (PCS) tools. We performed correlational coefficient analysis between disability and psychological scores and regression analysis of dependent variables (Pain, DASH, grip and pinch scores) and independent (psychological) variables. Finally, Z observed value was calculated to compare correlational coefficients between two diseases of CTS and CR.ResultsThe results of the correlational coefficient analysis indicate that all three HADS-A, HADS-D and PCS scores correlated with DASH score (r = 0.49, 0.37, 0.38 for HADS-A, HADS-D and PCS, respectively; p < 0.001 for all three). HADS-A also significantly correlated with VAS pain score (r = 0.41, P < 0.001) and grip strength (r = − 0.25, P = 0.016). Linear regression analysis revealed that anxiety has a notable value for DASH and VAS pain scores as well as grip strength. Fisher’s r correlation coefficient to z transformation, revealed that there was no difference between two diseases of CTS and CR in terms of the resulted r coefficients from correlational coefficient analysis between disability and psychological distress.ConclusionIt is concluded that psychological disorders are associated with disability in CR patients, with anxiety also correlating with objective disability parameter of grip strength. Finally, both CTS and CR patients’ disabilities associate with anxiety, depression, and catastrophysing thinking in a similar manner.Level of evidenceLevel IV (cross-sectional study).

Usefulness, acceptation and feasibility of electronic medical history tool in reflux disease.

To investigate usefulness, feasibility, and patient satisfaction of an electronic pre-consultation medical history tool (EPMH) in laryngopharyngeal reflux (LPR) work-up. Seventy-five patients with LPR were invited to complete electronic medical history assessment prior to laryngology consultation. EPMH collected the following parameters: demographic and epidemiological data, medication, medical and surgical histories, diet habits, stress and symptom findings. Stress and symptoms were assessed with perceived stress scale and reflux symptom score. Duration of consultation, acceptance, and satisfaction of patients (feasibility, usefulness, effectiveness, understanding of questions) were evaluated through a 9-item patient-reported outcome questionnaire. Seventy patients completed the evaluation (93% participation rate). The mean age of cohort was 51.2 ± 15.6years old. There were 35 females and 35 males. Patients who refused to participate (N = 5) were > 65years old. The consultation duration was significantly lower in patients who used the EPMH (11.3 ± 2.7min) compared with a control group (18.1 ± 5.1min; p = 0.001). Ninety percent of patients were satisfied about EPMH easiness and usefulness, while 97.1% thought that EPMH may improve the disease management. Patients would recommend similar approach for otolaryngological or other specialty consultations in 98.6% and 92.8% of cases, respectively. The use of EPMH is associated with adequate usefulness, feasibility, and satisfaction outcomes in patients with LPR. This software is a preliminary step in the development of an AI-based diagnostic decision support tool to help laryngologists in their daily practice. Future randomized controlled studies are needed to investigate the gain of similar approaches on the traditional consultation format.

6. Breast Flap Neurotization After Autologous Free Flap Breast Reconstruction: A Prospective Trial

Purpose: Restoration of breast sensation is an important factor to consider following autologous breast reconstruction (ABR). Flap neurotization may result in improved sensation after ABR, but current literature regarding both patient-reported outcomes and quantitative sensation after neurotization is inadequate and heterogenous. We present a prospective trial investigating the long-term outcomes of flap neurotization regarding breast sensation. Methods: 98 patients (n = 166 flaps) were prospectively evaluated for breast sensation and quality-of-life 1-5 years after ABR. This included 55 neurotized patients (n=97 neurotized breast flaps) and 44 non-neurotized patients (n=71 non-neurotized breast flaps). Evaluation consisted of the validated patient-reported questionnaire (BREAST-Q), a sensation-specific patient-reported questionnaire, and pressure-specified sensation testing at 9 locations on the breast using the AcroVal pressure-specified sensory device. Continuous variables were compared using independent t-tests. Categorical variables were compared using chi-squared analyses. Results: Non-neurotized patients were significantly more likely to report breast sensation was affecting their daily lives due to pain or discomfort, while neurotized patients were more likely to report they did not notice a difference in breast sensation after ABR or that the change in sensation was not affecting their daily lives (p= 0.035). While there was no significant difference in quantitative sensation between neurotized and non-neurotized patients at 1 year after ABR, neurotized patients were significantly more sensate at 4 of 9 testing locations on the breast (0.011<p<0.039) when evaluated 2-5 years after ABR. Conclusion: Breast sensation affects the daily lives of breast reconstruction patients and is an important long-term outcome to consider following ABR. Neurotization is associated with improved protective sensation as well as reduced pain and discomfort in the long-term after ABR.

OnabotulinumtoxinA in chronic migraine: is the response dose dependent?

BackgroundOnabotulinumtoxinA has been widely used for control of chronic migraine. The aim of the current study was to evaluate the efficacy of different doses of the onabotulinumtoxinA therapy in patients with chronic migraine.MethodsThis is a retrospective paired comparison study on patients with chronic migraine who received at least 3 rounds of 150 units of onabotulinumtoxinA followed by at least 3 rounds of 200 units of onabotulinumtoxinA. The data from the patient-reported questionnaires about headache days, severe headache days and wearing off periods were reviewed.ResultsA total of 175 patients were included in this study. The headache days and severe headache days decreased from 13.62 ± 10.79 and 5.88 ± 6.73 to 11.02 ± 10.61and 4.01 ± 4.89 days, after increase in the onabotulinumtoxinA dose, respectively (P < 0.001 for both comparisons). The favorable effect of the 200 units compared to the 150 units of the onabotulinumtoxinA, was independent from the headache location and the duration of the onabotulinumtoxinA 150 units therapy; and persisted as patients continued to receive the higher dose of onabotulinumtoxinA. Increase in the onabotulinumtoxinA dose was also associated with a decreased wearing off period (P < 0.05).ConclusionWe found that increase in the onabotulinumtoxinA is associated with fewer headache and severe headache days. Future randomized clinical trials are needed to confirm the dose-dependent response to onabotulinumtoxinA.

913-P: The Relationship between ASK12 Patient-Reported Medication Adherence Scores and Objective Measures of Adherence among Patients with Type 2 Diabetes

Background: Medication adherence may be measured either by (a) patient-reported measurement or (b) objective measurement using medication dispense data. Proportion of days covered (PDC) is an objective measure of adherence becoming more readily available in the electronic health record (EHR) and a threshold of &amp;lt; 80% is commonly used to identify a potential adherence problem. Using PDCs may be more efficient and clinically practical than using longer patient-reported adherence questionnaires. However, it is unknown how well the PDC and patient reported measures correlate. Methods: As part of a pragmatic randomized trial to evaluate an intervention designed to improve medication adherence in a Midwest health care system, 1,423 adults with type 2 diabetes (T2D) were identified at an index visit in primary care based on suboptimal diabetes control (AIC &amp;gt;8%) and at least one oral diabetes medication with PDC &amp;lt; 80%. They were surveyed shortly after the index visit to assess adherence using a validated 12 question ASK-12 instrument, with a response rate of 29% (80/280) . We evaluated the relationship between PDC and ASK-12 total/subscale scores using linear regression. Results: There were no significant associations found between PDC scores and the total ASK-12 score (β=-0.4, p=0.47) , or ASK-12 subscales of inconvenience/forgetfulness (β=-1.1, p=0.42) , treatment beliefs (β=-0.4, p=0.77) , behavior (β=-0.7, p=0.55) , or barriers (β=-0.7, p=0.44) . Conclusions: For patients above recommended A1C goal with a medication PDC &amp;lt; 80%, there was no correlation between PDC scores and patient-reported measures of adherence using ASK-12 total or component scores. This analysis raises questions about the validity and usefulness of EHR-derived PDC scores to identify poor medication adherence for patients with T2D. Disclosure P.Pawloski: None. M.Pankonin: None. D.Rehrauer: None. C.Frail: None. J.Anderson: None. L.Chumba: None. J.Ziegenfuss: None. P.J.O'connor: None. S.P.Dehmer: None. H.Ekstrom: None. J.Haapala: None. J.M.Sperl-hillen: None. M.Becker: None. A.Truitt: None. Funding NHLBI #R01HL136937