Association of Remote Patient-Reported Outcomes and Step Counts With Hospitalization or Death Among Patients With Advanced Cancer Undergoing Chemotherapy: Secondary Analysis of the PROStep Randomized Trial.

BACKGROUND: Patients with advanced cancer undergoing chemotherapy experience significant symptoms and declines in functional status, which are associated with poor outcomes. Remote monitoring of patient-reported outcomes (PROs; symptoms) and step counts (functional status) may proactively identify patients at risk of hospitalization or death. OBJECTIVE: The aim of this study is to evaluate the association of (1) longitudinal PROs with step counts and (2) PROs and step counts with hospitalization or death. METHODS: The PROStep randomized trial enrolled 108 patients with advanced gastrointestinal or lung cancers undergoing cytotoxic chemotherapy at a large academic cancer center. Patients were randomized to weekly text-based monitoring of 8 PROs plus continuous step count monitoring via Fitbit (Google) versus usual care. This preplanned secondary analysis included 57 of 75 patients randomized to the intervention who had PRO and step count data. We analyzed the associations between PROs and mean daily step counts and the associations of PROs and step counts with the composite outcome of hospitalization or death using bootstrapped generalized linear models to account for longitudinal data. RESULTS: Among 57 patients, the mean age was 57 (SD 10.9) years, 24 (42%) were female, 43 (75%) had advanced gastrointestinal cancer, 14 (25%) had advanced lung cancer, and 25 (44%) were hospitalized or died during follow-up. A 1-point weekly increase (on a 32-point scale) in aggregate PRO score was associated with 247 fewer mean daily steps (95% CI -277 to -213; P<.001). PROs most strongly associated with step count decline were patient-reported activity (daily step change -892), nausea score (-677), and constipation score (524). A 1-point weekly increase in aggregate PRO score was associated with 20% greater odds of hospitalization or death (adjusted odds ratio [aOR] 1.2, 95% CI 1.1-1.4; P=.01). PROs most strongly associated with hospitalization or death were pain (aOR 3.2, 95% CI 1.6-6.5; P<.001), decreased activity (aOR 3.2, 95% CI 1.4-7.1; P=.01), dyspnea (aOR 2.6, 95% CI 1.2-5.5; P=.02), and sadness (aOR 2.1, 95% CI 1.1-4.3; P=.03). A decrease in 1000 steps was associated with 16% greater odds of hospitalization or death (aOR 1.2, 95% CI 1.0-1.3; P=.03). Compared with baseline, mean daily step count decreased 7% (n=274 steps), 9% (n=351 steps), and 16% (n=667 steps) in the 3, 2, and 1 weeks before hospitalization or death, respectively. CONCLUSIONS: In this secondary analysis of a randomized trial among patients with advanced cancer, higher symptom burden and decreased step count were independently associated with and predictably worsened close to hospitalization or death. Future interventions should leverage longitudinal PRO and step count data to target interventions toward patients at risk for poor outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT04616768; https://clinicaltrials.gov/study/NCT04616768. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2021-054675.

Effectiveness of Virtual Reality in Reducing Perceived Pain and Anxiety Among Patients Within a Hospital System: Protocol for a Mixed Methods Study.

BACKGROUND: Within hospital systems, diverse subsets of patients are subject to minimally invasive procedures that provide therapeutic relief and necessary health data that are often perceived as anxiogenic or painful. These feelings are particularly relevant to patients experiencing procedures where they are conscious and not sedated or placed under general anesthesia that renders them incapacitated. Pharmacologic pain management and topical anesthetic creams are used to manage these feelings; however, distraction-based methods can provide nonpharmacologic means to modify the painful experience and discomfort often associated with these procedures. Recent studies support distraction as a useful method for reducing anxiety and pain and as a result, improving patient experience. Virtual reality (VR) is an emerging technology that provides an immersive user experience and can operate through a distraction-based method to reduce the negative or painful experience often related to procedures where the patient is conscious. Given the possible short-term and long-term outcomes of poorly managed pain and enduring among patients, health care professionals are challenged to improve patient well-being during medically essential procedures. OBJECTIVE: The purpose of this pilot project is to assess the efficacy of using VR as a distraction-based intervention for anxiety or pain management compared to other nonpharmacologic interventions in a variety of hospital settings, specifically in patients undergoing lumbar puncture procedures and bone marrow biopsies at the oncology ward, patients receiving nerve block for a broken bone at an anesthesia or surgical center, patients undergoing a cleaning at a dental clinic, patients conscious during an ablation procedure at a cardiology clinic, and patients awake during a kidney biopsy at a nephrology clinic. This will provide the framework for additional studies in other health care settings. METHODS: In a single visit, patients eligible for the study will complete brief preprocedural and postprocedural questionnaires about their perceived fear, anxiety, and pain levels. During the procedure, research assistants will place a VR headset on the patient and the patient will undergo a VR experience to distract from any pain felt from the procedure. Participants' vitals, including blood pressure, heart rate, and rate of respiration, will also be recorded before, during, and after the procedure. RESULTS: The study is already underway, and results support a decrease in perceived pain by 1.00 and a decrease in perceived anxiety by 0.3 compared to the control group (on a 10-point Likert scale). Among the VR intervention group, the average rating for comfort was 4.35 out of 5. CONCLUSIONS: This study will provide greater insight into how patients' perception of anxiety and pain could potentially be altered. Furthermore, metrics related to the operational efficiency of providing a VR intervention compared to a control will provide insight into the feasibility and integration of such technologies in routine practice. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52649.

Development and Validation of a Mixed-Reality Simulator for Reducing Biopsy Core Deviation During Simulated Freehand Systematic Prostate Biopsy.

INTRODUCTION: We describe the development and validation of a mixed-reality prostate biopsy (PBx) simulator with built-in guidance aids and real-time 3-dimensional visualization. METHODS: We evaluated our simulator during one-on-one training sessions with urology residents and attendings from 2018 to 2022. Participants performed freehand, side-fire, double-sextant transrectal ultrasound-guided systematic prostate biopsy (sPBx). After a baseline assessment (first set of 12 biopsy cores), participants trained for 25 minutes with visualization and cognitive aids activated. Training was followed by an exit set of 12 biopsy cores without visualization or cognitive aids and afterward, subjective assessment by trainees of the simulator. Deviation is the shortest distance of the center of a core from its intended template location. RESULTS: Baseline deviations (mean ± SD) for residents (n = 24) and attendings (n = 4) were 13.4 ± 8.9 mm and 8.5 ± 3.6 mm ( P < 0.001), respectively. Posttraining deviations were 8.7 ± 6.6 mm and 7.6 ± 3.7 mm ( P = 0.271), respectively. Deviations between baseline and exit were decreased significantly for residents ( P < 0.001) but not for attendings ( P = 0.093). Overall feedback from participants was positive. Confidence in performing a PBx increased in novices after training ( P = 0.011) and did not change among attendings ( P = 0.180). CONCLUSIONS: A new PBx simulator can quantify and improve accuracy during simulated freehand sPBx while providing visualization and graphical feedback. Improved simulated sPBx accuracy could lead to more even distribution of biopsy cores within the prostate when performed in clinical settings, possibly reducing the high risk of missing an existing lesion and thus decreasing the time to initiating treatment, if indicated.

Remote Patient-Reported Outcomes and Activity Monitoring to Improve Patient-Clinician Communication Regarding Symptoms and Functional Status: A Randomized Controlled Trial.

PURPOSE: Routine collection of patient-generated health data (PGHD) may promote earlier recognition of symptomatic and functional decline. This trial assessed the impact of an intervention integrating remote PGHD collection with patient nudges on symptom and functional status understanding between patients with advanced cancer and their oncology team. METHODS: This three-arm randomized controlled trial was conducted from November 19, 2020, to December 17, 2021, at a large tertiary oncology practice. We enrolled patients with stage IV GI and lung cancers undergoing chemotherapy. Over 6 months, patients in two intervention arms received PROStep-weekly text message-based symptom surveys and passive activity monitoring using a wearable accelerometer. PGHD were summarized in dashboards given to patients' oncology team before appointments. One intervention arm received an additional text-based active choice prompt to discuss worsening symptoms or functional status with their clinician. Control patients did not receive PROStep. The coprimary outcomes patient perceptions of oncology team symptom and functional understanding at 6 months were measured on a 1-5 Likert scale (5 = high understanding). RESULTS: One hundred eight patients enrolled: 55% male, 81% White, and 77% had GI cancers. Patient-reported clinician understanding did not differ between control and intervention arms for symptoms (4.5 v 4.5; P = .87) or functional status (4.5 v 4.3; P = .31). In the intervention arms, combined patient adherence to weekly symptom reports and daily activity monitoring was 64% and 53%, respectively. Intervention patients in the PROStep versus PROStep + active choice arms reported low burden from wearing the accelerometer (mean burden [standard deviation], 2.7 [1.3] v 2.1 [1.3]; P = .15) and completing surveys (2.1 [1.2] v 1.9 [1.3]; P = .44). CONCLUSION: Patients receiving PROStep reported high understanding of symptoms and functional status from their oncology team, although this did not differ from controls.

Multicenter assessment of augmented reality registration methods for image-guided interventions.

PURPOSE: To evaluate manual and automatic registration times and registration accuracies on HoloLens 2 for aligning a 3D CT phantom model onto a CT grid, a crucial step for intuitive 3D navigation during CT-guided interventions; to compare registration times between HoloLens 1 and 2. METHODS: Eighteen participants in various stages of clinical training across two academic centers performed registration of a 3D CT phantom model onto a CT grid using HoloLens 2. Registration times and accuracies were compared among different registration methods, clinical experience levels, and consecutive attempts. Registration times were also compared retrospectively to prior HoloLens 1 results. RESULTS: Mean aggregate manual registration times were 27.7 s, 24.3 s, and 72.8 s for one-handed gesture, two-handed gesture, and Xbox controller, respectively; mean automatic registration time was 5.3 s (ANOVA p < 0.0001). No significant difference in registration times was found among attendings, residents and fellows, and medical students (p > 0.05). Significant improvements in registration times were detected across consecutive attempts using hand gestures (p < 0.01). Compared to prior HoloLens 1 data, hand gesture registration was 81.7% faster with HoloLens 2 (p < 0.05). Registration accuracies were not significantly different across manual registration methods, measuring at 5.9 mm, 9.5 mm, and 8.6 mm with one-handed gesture, two-handed gesture, and Xbox controller, respectively (p > 0.05). CONCLUSIONS: Manual registration times decreased significantly on HoloLens 2, approaching those of automatic registration and outperforming Xbox controller registration. Fast, adaptive, and accurate registration of holographic models of cross-sectional imaging is paramount for the implementation of augmented reality-assisted 3D navigation during CT-guided interventions.

Patient and clinician nudges to improve symptom management in advanced cancer using patient-generated health data: study protocol for the PROStep randomised controlled trial.

INTRODUCTION: Patients with advanced cancers often face significant symptoms from their cancer and adverse effects from cancer-associated therapy. Patient-generated health data (PGHD) are routinely collected information about symptoms and activity levels that patients either directly report or passively record using devices such as wearable accelerometers. The objective of this study was to test the impact of an intervention integrating remote collection of PGHD with clinician and patient nudges to inform communication between patients with advanced cancer and their oncology team regarding symptom burden and functional status. METHODS AND ANALYSIS: This single-centre prospective randomised controlled trial randomises patients with metastatic gastrointestinal or lung cancers into one of three arms: (A) usual care, (B) an intervention that integrates PGHD (including weekly text-based symptom surveys and passively recorded step counts) into a dashboard delivered to oncology clinicians at each visit and (C) the same intervention as arm B but with an additional text-based active choice intervention to patients to encourage discussing their symptoms with their oncology team. The study will enrol approximately 125 participants. The coprimary outcomes are patient perceptions of their oncology team's understanding of their symptoms and their functional status. Secondary outcomes are intervention utility and adherence. ETHICS AND DISSEMINATION: This study has been approved by the institutional review board at the University of Pennsylvania. Study results will be disseminated using methods that describe the results in ways that key stakeholders can best understand and implement. TRIAL REGISTRATION NUMBERS: NCT04616768 and 843 616.

Etiologies, incidence, and demographics of lumbar vertebral fractures in U.S. emergency departments.

Background: Lumbar vertebral fractures are debilitating injuries widely associated with significant patient deformity, disability, pain, and potentially neurological deficit. This cross-sectional database study investigates the most frequent annual etiologies of lumbar vertebral fractures presented to emergency departments throughout the United States (U.S.) from 2010-2018. Methods: The National Electronic Injury Surveillance System (NEISS) database was used to identify all patients who visited participating emergency departments between 2010-2018 and were diagnosed with a lumbar spine fracture. Population estimates by age (18+) were obtained from annual U.S. Census estimates and used to calculate annual incidence rates of lumbar fractures per 100,000 people. Results: The annual incidence rate of total lumbar fractures in the U.S. increased from 14.6 to 22.5 per 100,000 people from 2010-2018 (54%). From 2010-2018, there were 382,914 [95% confidence interval (CI): 382,855-382,973] lumbar fractures in the U.S. This increased from 34,328 (95% CI: 34,277-34,379) in 2010 to 57,098 (95% CI: 57,044-57,152) in 2018 (66.3%). Men composed 40.2% and women made up 59.8% of patients. Mean patient age increased by 2.96 years from 65.5 (95% CI: 65.38-65.62) years in 2010 to 68.4 (95% CI: 68.32-68.48) years in 2018 (4.5%). From 2010-2018, floors, stairs/steps, and ladders were the most common etiologies of lumbar fractures. Estimated sum of floor-related fractures was 80,054 (95% CI: 79,986-80,122), stair/step-related fractures was 48,274 (95% CI: 48,209-48,339), and ladder-related fractures was 31,053 (95% CI: 30,987-31,119). The increase in these three etiologies accounted for 48% of the total increase of all-cause lumbar fractures between 2010 and 2018. Conclusions: The volume of lumbar vertebral fracture has increased over the last near decade (66.3%), and approximately half (48%) of these fractures can be attributed to accidents caused by flooring, stairs/steps, and ladder-related injuries. The increasing mean patient age, as well as accidents involving ladders, were found to be statistically correlated with the rise in total lumbar fracture volume.

Attitude is everything: keep probe pitch neutral during side-fire prostate biopsy. A simulator study.

OBJECTIVES: To develop and validate on a simulator a learnable technique to decrease deviation of biopsied cores from the template schema during freehand, side-fire systematic prostate biopsy (sPBx) with the goal of reducing prostate biopsy (PBx) false-negatives, thereby facilitating earlier sampling, diagnosis and treatment of clinically significant prostate cancer. PARTICIPANTS AND METHODS: Using a PBx simulator with real-time three-dimensional visualization, we devised a freehand, pitch-neutral (0°, horizontal plane), side-fire, transrectal ultrasonography (TRUS)-guided sPBx technique in the left lateral decubitus position. Thirty-four trainees on four Canadian and US urology programmes learned the technique on the same simulator, which recorded deviation from the intended template location in a double-sextant template as well as the TRUS probe pitch at the time of sampling. We defined deviation as the shortest distance in millimeters between a core centre and its intended template location, template deviation as the mean of all deviations in a template, and mastery as achieving a template deviation ≤5.0 mm. RESULTS: All results are reported as mean ± sd. The mean absolute pitch and template deviation before learning the technique (baseline) were 8.2 ± 4.1° and 8.0 ± 2.7 mm, respectively, and after mastering the technique decreased to 4.5 ± 2.7° (P = 0.001) and 4.5 ± 0.6 mm (P < 0.001). Template deviation was related to mean absolute pitch (P < 0.001) and increased by 0.5 mm on average with each 1° increase in mean absolute pitch. Participants achieved mastery after practising 3.9 ± 2.9 double-sextant sets. There was no difference in time to perform a double-sextant set at baseline (277 ± 102 s) and mastery (283 ± 101 s; P = 0.39). CONCLUSION: A pitch-neutral side-fire technique reduced template deviation during simulated freehand TRUS-guided sPBx, suggesting it may also reduce PBx false-negatives in patients in a future clinical trial. This pitch-neutral technique can be taught and learned; the University of Florida has been teaching it to all Urology residents for the last 2 years.

Appraisal of clinical practice guidelines for the evaluation and management of neck masses in children.

AIM: The purpose of this systematic review was to use the Appraisal of Guidelines for Research and Evaluation tool to assess the methodological quality of clinical practice guidelines (CPGs) for the workup and management of paediatric neck masses. METHODS: MEDLINE, Embase, Cochrane and grey literature were searched to identify CPG incorporating paediatric neck masses. Four authors with previous training of the Appraisal of Guidelines for Research and Evaluation tool evaluated the included studies. RESULTS: Nine studies met inclusion criteria. The highest scoring domains were 'Scope and Purpose' (74.0 ± 4.5) and 'Clarity of Presentation' (72.9 ± 6.3). The lowest scoring domains were 'Rigour and Development' (18.8 ± 7.5) and 'Applicability' (23.7 ± 6.1). One study was 'High' quality, three received scores of 'Average' and five were found to be 'Low' quality. CONCLUSION: The majority of paediatric neck mass CPGs were low to average quality. The domains in need of greatest improvement were 'Rigour and Development' and 'Applicability', suggesting significant concerns in current CPGs focused on paediatric neck masses.