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BACKGROUND Accurate self-reported symptomatic toxicity documentation via the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is essential throughout cancer treatment to ensure safety and understand therapeutic efficacy. However, the capture of accurate toxicities from patients undergoing radiation therapy is challenging because this is generally provided only at the time of scheduled visits. OBJECTIVE This study seeks to establish the usability and feasibility of a mobile PRO-CTCAE Administration System (mPROS) to capture toxicities related to radiation therapy. METHODS English-speaking adult patients who were undergoing radiation therapy for cancer were enrolled and given a brief demonstration of the Say All Your Symptoms (SAYS) and Symptom Tracking Entry Program (STEP) interfaces of the mPROS app, followed by a patient-use phase where patient actions were observed as they navigated mPROS to enter toxicities. Patient feedback was captured via a semistructured interview and brief questionnaire. RESULTS We enrolled 25 patients (age: mean 60.7 years; females: n=13, 52%; White patients: n=13; 52%; non-Hispanic patients: n=19, 76%; college graduates: n=17, 68%). Patients almost equally preferred the SAYS (n=14, 56%) or STEP (n=11, 44%) interfaces, with 21 patients (84%) agreeing that they would use mPROS to report their symptoms to their health care team and 19 patients (76%) agreeing that they would recommend mPROS to others. CONCLUSIONS The mPROS app is usable and feasible for facilitating the patient reporting of radiation therapy–related symptomatic toxicities. A revised version of mPROS that incorporates patient input and includes electronic health record integration is being developed and validated as part of a multicenter trial.

Background Accurate self-reported symptomatic toxicity documentation via the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is essential throughout cancer treatment to ensure safety and understand therapeutic efficacy. However, the capture of accurate toxicities from patients undergoing radiation therapy is challenging because this is generally provided only at the time of scheduled visits. Objective This study seeks to establish the usability and feasibility of a mobile PRO-CTCAE Administration System (mPROS) to capture toxicities related to radiation therapy. Methods English-speaking adult patients who were undergoing radiation therapy for cancer were enrolled and given a brief demonstration of the Say All Your Symptoms (SAYS) and Symptom Tracking Entry Program (STEP) interfaces of the mPROS app, followed by a patient-use phase where patient actions were observed as they navigated mPROS to enter toxicities. Patient feedback was captured via a semistructured interview and brief questionnaire. Results We enrolled 25 patients (age: mean 60.7 years; females: n=13, 52%; White patients: n=13; 52%; non-Hispanic patients: n=19, 76%; college graduates: n=17, 68%). Patients almost equally preferred the SAYS (n=14, 56%) or STEP (n=11, 44%) interfaces, with 21 patients (84%) agreeing that they would use mPROS to report their symptoms to their health care team and 19 patients (76%) agreeing that they would recommend mPROS to others. Conclusions The mPROS app is usable and feasible for facilitating the patient reporting of radiation therapy–related symptomatic toxicities. A revised version of mPROS that incorporates patient input and includes electronic health record integration is being developed and validated as part of a multicenter trial.

BackgroundThere is great interest in finding ways to identify patients who will develop toxicity to cancer therapies. This has become especially pressing in the era of immune therapy, where toxicity can be long-lasting and life-altering, and primarily comes in the form of immune-related adverse effects (irAEs). Treatment with the first drugs in this class, anti-programmed death 1 (anti-PD1)/programmed death-ligand 1 (PDL1) checkpoint therapies, results in grade 2 or higher irAEs in up to 25%–30% of patients, which occur most commonly within the first 6 months of treatment and can include arthralgias, rash, pruritus, pneumonitis, diarrhea and/or colitis, hepatitis, and endocrinopathies. We tested the hypothesis that germline microRNA pathway functional variants, known to predict altered systemic stress responses to cancer therapies, would predict irAEs in patients across cancer types.MethodsMicroRNA pathway variants were evaluated for an association with grade 2 or higher toxicity using four classifiers on 62 patients with melanoma, and then the panel’s performance was validated on 99 patients with other cancer types. Trained classifiers included classification trees, LASSO-regularized logistic regression, boosted trees, and random forests. Final performance measures were reported on the training set using leave-one-out cross validation and validated on held-out samples. The predicted probability of toxicity was evaluated for its association, if any, with response categories to anti-PD1/PDL1 therapy in the melanoma cohort.ResultsA biomarker panel was identified that predicts toxicity with 80% accuracy (F1=0.76, area under the curve (AUC)=0.82) in the melanoma training cohort and 77.6% accuracy (F1=0.621, AUC=0.778) in the pan-cancer validation cohort. In the melanoma cohort, the predictive probability of toxicity was not associated with response categories to anti-PD1/PDL1 therapy (p=0.70). In the same cohort, the most significant biomarker of toxicity in RAC1, predicting a greater than ninefold increased risk of toxicity (pConclusionsA germline microRNA-based biomarker signature predicts grade 2 and higher irAEs to anti-PD1/PDL1 therapy, regardless of tumor type, in a pan-cancer manner. These findings represent an important step toward personalizing checkpoint therapy, the use of which is growing rapidly.

A blood-based, low cost alternative to radiation intensive CT and PET imaging is critically needed for cancer prognosis and management of its treatment. "Liquid biopsies" of circulating tumor cells (CTCs) from a relatively non-invasive blood draw are particularly ideal, as they can be repeated regularly to provide up to date molecular information about the cancer, which would also open up key opportunities for personalized therapies. Beyond solely diagnostic applications, CTCs are also a subject of interest for drug development and cancer research. In this paper, we adapt a technology previously introduced, combining the use of micro-scale vortices and inertial focusing, specifically for the high-purity extraction of CTCs from blood samples. First, we systematically varied parameters including channel dimensions and flow rates to arrive at an optimal device for maximum trapping efficiency and purity. Second, we validated the final device for capture of cancer cell lines in blood, considering several factors, including the effect of blood dilution, red blood cell lysis and cell deformability, while demonstrating cell viability and independence on EpCAM expression. Finally, as a proof-of-concept, CTCs were successfully extracted and enumerated from the blood of patients with breast (N = 4, 25-51 CTCs per 7.5 mL) and lung cancer (N = 8, 23-317 CTCs per 7.5 mL). Importantly, samples were highly pure with limited leukocyte contamination (purity 57-94%). This Vortex approach offers significant advantages over existing technologies, especially in terms of processing time (20 min for 7.5 mL of whole blood), sample concentration (collecting cells in a small volume down to 300 μL), applicability to various cancer types, cell integrity and purity. We anticipate that its simplicity will aid widespread adoption by clinicians and biologists who desire to not only enumerate CTCs, but also uncover new CTC biology, such as unique gene mutations, vesicle secretion and roles in metastatic processes.

This study aimed to identify pre-treatment and immediate early treatment factors predicting continuous positive airway pressure (CPAP) use during the first week of therapy, when the pattern of non-adherence is established. Four domains of potential predictors were examined: pre-treatment demographic and clinical factors, patients' perceived self-efficacy, treatment delivery (mask leak and bothering side effects) and immediate disease reduction (residual respiratory events and flow limitation). The Autoset™ Clinical System objectively documented daily CPAP use, mask leak, residual respiratory events and flow limitation. Ninety-one CPAP-naive patients with newly diagnosed obstructive sleep apnea were followed for 1week after treatment initiation. Mean CPAP daily use during the first week was 3.4±2.7h, with significantly lower use observed in black than non-black participants (2.7 versus 4.4h, respectively, P=0.002). Less intimacy with partners caused by CPAP was the only treatment side effect correlated with CPAP use (r=-0.300, P=0.025). Reduced CPAP use during the first week was associated simultaneously with being black, higher residual apnea-hypopnea index and the treatment side effect of less intimacy with partners. The three factors together accounted for 25.4% of the variance in the CPAP use (R(2) =0.254, P

Study objectives Despite significant medical sequelae of obstructive sleep apnea (OSA), the condition remains undiagnosed and untreated in many affected individuals. We explored the feasibility of a comprehensive, telemedicine-based OSA management pathway in a community-based Veteran cohort. Methods This prospective, parallel-group randomized pilot study assessed feasibility of a telemedicine-based pathway for OSA evaluation and management in comparison to a more traditional, in-person care model. The study included 60 Veterans at the Philadelphia Veterans Affairs Medical Center and two affiliated community-based outpatient clinics. Telemedicine pathway feasibility, acceptability, and outcomes were assessed through a variety of quantitative (Functional Outcomes of Sleep Questionnaire, dropout rates, positive airway pressure [PAP] adherence rates, participant satisfaction ratings) and qualitative (verbal feedback) metrics. Results There was no significant difference in functional outcome changes, patient satisfaction, dropout rates, or objectively measured PAP adherence between groups after 3 months of treatment. Telemedicine participants showed greater improvement in mental health scores, and their feedback was overwhelmingly positive. Conclusions Our pilot study suggests that telemedicine-based management of OSA patients is feasible in terms of patient functional outcomes and overall satisfaction with care. Future studies should include larger populations to further elucidate these findings while assessing provider- and patient-related cost effectiveness.

The consideration of assistive technology devices and services is required during the development of every Individualized Educational Program (IEP) according to the Individuals with Disabilities Act, Amendments of 1997 (IDEA'97). Assistive technology devices and services, which the IEP team determines are required by a student in order to benefit from a free appropriate public education (FAPE), must be written into the IEP. Despite this requirement, mere has been no agreed upon description of high quality assistive technology services. This article describes the activities of a national group of assistive technology professionals known as the Quality Indicators for Assistive Technology Services (QIAT) Consortium. The QIAT Consortium was formed to initiate a nationwide dialogue regarding quality indicators for a variety of assistive technology service areas. The work of the Consortium to date is discussed and the current set of indicators is included. Processes used in the development of the indicators are described. Implications for future use of the indicators and future development activities are discussed.

This study aimed to identify pre-treatment and immediate early treatment factors predicting continuous positive airway pressure (CPAP) use during the first week of therapy, when the pattern of non-adherence is established. Four domains of potential predictors were examined: pre-treatment demographic and clinical factors, patients’ perceived self-efficacy, treatment delivery (mask leak and bothering side effects), and immediate disease reduction (residual respiratory events and flow limitation). The Autoset™ Clinical System objectively documented daily CPAP use, mask leak, residual respiratory events, and flow limitation. Ninety-one CPAP-naïve patients with newly diagnosed obstructive sleep apnea were followed for 1 week after treatment initiation. Mean CPAP daily use during the first week was 3.4 ± 2.7 hours, with significantly lower use observed in Black than non-Black participants (2.7 vs. 4.4 hours, respectively, p= 0.002). Less intimacy with partners caused by CPAP was the only treatment side effect correlated with CPAP use (r= -0.300, p=0.025). Reduced CPAP use during the first week was simultaneously associated with being Black, higher residual apnea-hypopnea index, and the treatment side effect of less intimacy with partners. The three factors together accounted for 25.4% of the variance in the CPAP use (R2=0.254, p

The purpose of this study was to evaluate the Self-Efficacy Measure for Sleep Apnea (SEMSA) designed to assess adherence-related cognitions.Subjects completed the questionnaire prior to the initiation of continuous positive airway pressure (CPAP) treatment. Test-retest reliability of the instrument was evaluated by having a subset of subjects complete the SEMSA a second time at home, 1 week later, returning the questionnaire by mail.213 subjects with newly diagnosed obstructive sleep apnea were recruited from the clinic populations of 2 sleep disorders centers.Content validity was confirmed by a panel of expert judges. Confirmatory factor analysis validated the 3 a priori sub-scales: risk perception, outcome expectancies, and treatment self-efficacy. The internal consistency of the total instrument was 0.92. Test-retest reliability coefficients (N = 20) were estimated to be 0.68, P = 0.001, for Perceived Risk; 0.77, P more more than 0.0001, for Outcome Expectancies; and 0.71, P = 0.0005, for the Treatment Self-Efficacy subscale. Subject responses indicated that approximately half of the subjects did not perceive problems with concentration, sexual performance, sleepy driving, or an accident as related to sleep apnea. More than 60% of the subjects acknowledged most of the benefits of CPAP presented to them, but only 53% associated CPAP use with enhanced sexual performance. Frequently identified barriers to treatment use were nasal stuffiness, claustrophobia, and disturbing bed partner sleep.These findings indicate that the SEMSA has strong psychometric properties and has the potential for identifying patient perceptions that may indicate those most likely to not adhere to treatment.

In a discussion of Henry IV, Part One I can count on at least one student to remark that Shakespeare might have created for Hal a worthier opposite than Hotspur. Hotspur may be a great warrior, the student admits, but he is also impatient, unfeeling, and intolerably conceited. Pressed to specify the moments in the play that justify this negative view, the student is likely to point to Act II, Scene 3, Hotspur's first scene with Kate. The mention of the scene triggers other members of the class to harsher criticism. "Look at how he greets her: 'Oh, it's you; well, I'm leaving.'" "After she goes on for half a column about how worried she is, he ignores her and calls his servant to find out about his horse." "When she insists on his attention, he evades her by playing on words." "Even worse, he tells her flat out that he doesn't love her." By this point in the discussion Hotspur's worthiness as a foil to Hal is no longer the issue. He has so fallen in the students' esteem that Sir Toby's indignant question about Malvolio seems more to the point: "Shall this fellow live?" This kind of episode probably seems familiar to anyone who teaches dramatic literature in an English department. I have learned to use such moments to remind my students that no character in a play can be arraigned on the evidence of words alone. When I ask the students to tell me how Hotspur and Kate are positioned onstage during this scene, I am likely to hear that Kate has yet to pass through the doorway. An argument of such intensity, I am told, implies physical distance. But what, I ask, of Kate's threat to break her spouse's little finger? How close must she be standing to Hotspur to make that "threat" real? (Uneasy silence.) Given all the violent things a warring couple could say to one another, why does Kate call Hotspur only a "mad-headed ape" and a "paraquito"? (Rustling of paper, shifting about in seats.) What must be happening in this scene to prompt the wife-abusing Hotspur to invite Kate to follow him to war? (Dead silence.) These unanswered questions are the usual prologue to a careful, theatrically alert rereading of a love scene, where the belligerent language wittily counterpoints the pair's physical intimacy. As soon as the students decipher the cues for action in the language, the supposedly unfeeling Hotspur is restored to favor. More importantly, they recognize how completely drama is an art of sights and sounds: what they see or imagine is as vital in interpreting a play as what they hear or read.

S HORTLY AFTER THE DISCOVERY OF DUNCAN S MURDER, daybreak scatters pale light over the castle's tower, battlements, and gateway. The courtiers have withdrawn confusedly to their chambers, Malcolm has fled, and Macbeth, alone in the courtyard, sits on the dead king's throne. The castle gates swing slowly open. A grotesquely distorted figure appears, followed by another such figure, then another, and another. As Macbeth looks on, appalled and fascinated, these cripples drag their limbless, sightless, or diseased bodies across the courtyard toward the throne. Macbeth's body tenses as the cripples approach. His alarm grows when voices from a great distance hail him as king. Suddenly, those voices are near at hand, on the battlements directly above the throne. Three voodoo priestesses huddle together there, chanting to the pounding of invisible drums. The pale dawn sky turns an angry red, the drums beat more insistently, the women's voices grow louder, and the cripples draw closer to the throne. Far above the throne, on the roof of the tower, Hecate appears, arms outstretched, his black-cloaked figure silhouetted against the red sky. At the sound of his voice, the cripples stop moving and the priestesses cease their chant. In the stillness, Hecate looks down at Macbeth and curses him. On the last word of the curse, the drums sound once, then are silent, and the sky fades to black. At the Lafayette Theatre in Harlem on 14 April 1936, the house lights came up at this point, closing the first act of what came to be known as the "Voodoo" Macbeth. Several months earlier, a newcomer to the New York stage, Orson Welles, had been invited to direct a classic play for the Federal Theatre's Negro Theatre Project. 1 He chose Macbeth after his wife, Virginia Nicholson, suggested a production set in Haiti, with the witches as voodoo priestesses. Turning this idea into theatrical reality, Welles made theatrical history. The "Voodoo" Macbeth was the first black professional production of Shakespeare, an important critical and commercial success for the Federal Theatre, and an appropriately dazzling debut for its twenty-year-old director. It was also a respectful