The rat shoulder animal model has been used previously to study the role of intrinsic injury (modeled as an acute insult to the tendon), extrinsic injury (modeled as external subacromial impingement), and overuse factors on rotator cuff tendinosis. These studies demonstrated that it is possible to produce rotator cuff tendinosis with any one of these factors in isolation. The current study uses the rat shoulder model to study the roles of extrinsic compression, overuse, and overuse in combination with extrinsic compression, on the development of rotator cuff tendinosis. The results of this study demonstrate that the injury created by overuse plus extrinsic compression is greater than the injuries created by overuse or extrinsic compression alone, particularly when important biomechanical variables are considered. While ineffective in causing a change in supraspinatus tendon properties in animals with normal cage activity, extrinsic compression had a significant and dramatic effect when it was combined with overuse activity. Without an additional factor, such as overhead activity, the extrinsic compression alone may be insufficient to cause tendinosis. The results of the present study support the role of multiple factors in the etiology of some rotator cuff injuries.

Background Heterogeneous respiratory system static compliance (CRS) values and levels of hypoxemia in patients with novel coronavirus disease (COVID-19) requiring mechanical ventilation have been reported in previous small-case series or studies conducted at a national level. Methods We designed a retrospective observational cohort study with rapid data gathering from the international COVID-19 Critical Care Consortium study to comprehensively describe CRS—calculated as: tidal volume/[airway plateau pressure-positive end-expiratory pressure (PEEP)]—and its association with ventilatory management and outcomes of COVID-19 patients on mechanical ventilation (MV), admitted to intensive care units (ICU) worldwide. Results We studied 745 patients from 22 countries, who required admission to the ICU and MV from January 14 to December 31, 2020, and presented at least one value of CRS within the first seven days of MV. Median (IQR) age was 62 (52–71), patients were predominantly males (68%) and from Europe/North and South America (88%). CRS, within 48 h from endotracheal intubation, was available in 649 patients and was neither associated with the duration from onset of symptoms to commencement of MV (p = 0.417) nor with PaO2/FiO2 (p = 0.100). Females presented lower CRS than males (95% CI of CRS difference between females-males: − 11.8 to − 7.4 mL/cmH2O p < 0.001), and although females presented higher body mass index (BMI), association of BMI with CRS was marginal (p = 0.139). Ventilatory management varied across CRS range, resulting in a significant association between CRS and driving pressure (estimated decrease − 0.31 cmH2O/L per mL/cmH20 of CRS, 95% CI − 0.48 to − 0.14, p < 0.001). Overall, 28-day ICU mortality, accounting for the competing risk of being discharged within the period, was 35.6% (SE 1.7). Cox proportional hazard analysis demonstrated that CRS (+ 10 mL/cm H2O) was only associated with being discharge from the ICU within 28 days (HR 1.14, 95% CI 1.02–1.28, p = 0.018). Conclusions This multicentre report provides a comprehensive account of CRS in COVID-19 patients on MV. CRS measured within 48 h from commencement of MV has marginal predictive value for 28-day mortality, but was associated with being discharged from ICU within the same period. Trial documentation: Available at https://www.covid-critical.com/study. Trial registration: ACTRN12620000421932.

IntroductionPatients 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 analysisThis 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 disseminationThis 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 numbersNCT04616768 and 843 616.

1581 Background: Patients with advanced cancer undergoing chemotherapy experience significant symptoms and declines in functional status, which are often associated with poor outcomes. Remote monitoring of PROs (symptoms) and step counts (functional status), may proactively identify patients at risk of hospitalization or death. Our objectives were 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 (NCT04616768) enrolled 108 patients with advanced gastrointestinal (GI) or lung cancers undergoing cytotoxic chemotherapy at a large academic cancer center. Patients were randomized to weekly text-based monitoring of 8 PROs (each measured on a 0-4 scale) + continuous step count monitoring via Fitbit, vs usual care. This pre-planned secondary analysis included 57 of 75 patients randomized to the intervention who had PRO and step data. We analyzed associations between PROs and mean daily step count, and 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 evaluable patients, mean age was 57 years, 24 (42%) were female, 49 (86%) were White, 43 (75%) had advanced GI cancer, and 14 (25%) had advanced lung cancer. 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, -213, p < 0.001). PROs most strongly associated with step count decline were patient-reported activity level (daily step change -892), nausea (-677), and constipation (-524). 25 patients (44%) were hospitalized (n = 21) or died (n = 8). 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 = 0.008). PROs most strongly associated with hospitalization/death were pain (aOR 3.2), decreased activity (aOR 3.2), dypsnea (aOR 2.6) and sadness (aOR 2.1). 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 = 0.03). Compared to baseline, mean daily step count decreased 6.7%, 8.5%, 16.2% in the 3, 2, and 1 weeks prior to hospitalization/death. Mean aggregate PRO score increased by 11.0%, 25.3%, 36.4% in the 3, 2, and 1 weeks prior to hospitalization/death. Conclusions: In this secondary analysis of a randomized trial, increased PRO-based symptom burden was associated with lower daily step count. 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 data to identify risk for poor outcomes. Clinical trial information: NCT04616768 .

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 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 (NCT04616768) enrolled 108 patients with advanced gastrointestinal (GI) or lung cancers undergoing cytotoxic chemotherapy at a large academic cancer center. Patients were randomized to weekly text-based monitoring of 8 PROs + continuous step count monitoring via Fitbit, vs usual care. This pre-planned secondary analysis included 57 of 75 patients randomized to the intervention who had PRO and step data. We analyzed associations between PROs and mean daily step count, and 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, mean age was 57 years, 24 (42%) were female, 43 (75%) had advanced GI 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, -213, p <0.001). PROs most strongly associated with step count decline were patient-reported activity (daily step change -892), nausea (-677), and constipation (-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 = 0.008). PROs most strongly associated with hospitalization/death were pain (aOR 3.2), decreased activity (aOR 3.2), dyspnea (aOR 2.6) and sadness (aOR 2.1). 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 = 0.03). Compared to baseline, mean daily step count decreased 6.7%, 8.5%, 16.2% in the 3, 2, and 1 weeks prior to hospitalization/death. 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 data to target interventions towards patients at risk for poor outcomes. CLINICALTRIAL ClinicalTrials.gov NCT04616768 INTERNATIONAL REGISTERED REPORT RR2-http://dx.doi.org/10.1136/bmjopen-2021-054675