Integration of musculoskeletal physical therapy care in the patient-centred medical home (IMPaC): protocol for a single-site randomised clinical trial.

INTRODUCTION: Annually, >50% of the US population reports musculoskeletal (MSK) pain to a provider, with direct healthcare costs exceeding $185 billion. The number of MSK complaints and the associated costs are projected to rise, increasing demand for and burden on providers. Establishing new care models to decrease inefficiencies may lower costs and optimise care delivery. The purpose of the Integration of Musculoskeletal Physical Therapy Care in the Patient-Centred Medical Home (IMPaC) study is to compare initial evaluation by a physical therapist (PT) integrated into primary care versus initial evaluation by a primary care provider (PCP) for patients with an MSK complaint. METHODS AND ANALYSIS: This single-site, randomised clinical trial will test the hypothesis that a PT within a primary care facility as the initial evaluating provider for patients with an MSK complaint will lower costs, improve utilisation (ie, reduced opioid prescriptions, imaging, physical therapy, emergency department visits and missed appointments) and increase patient satisfaction within 90 days of the index visit compared with PCP evaluation in the same location. Participants aged ≥18 years will be randomised with equal allocation and stratified by pain site (ie, back, knee, upper extremity and other). In the initial PT evaluation arm, patients will be assessed, treated and then instructed to complete a home exercise programme. The PCP cohort will undergo a usual PCP evaluation, and if a referral to physical therapy is made, patients will be randomised to onsite versus offsite physical therapy. Differences will be calculated and tested across the two arms. ETHICS AND DISSEMINATION: Approval was received from the Duke University Institutional Review Board (01 May 2017) and the National Institutes of Health, National Centre for Advancing Translational Sciences (01 January 2017). Findings will be communicated via quarterly reports to funding bodies and disseminated through scientific publications. TRIAL REGISTRATION NUMBER: NCT03110211; Pre-results.

De novo belatacept in clinical vascularized composite allotransplantation.

Most immunosuppressive regimens used in clinical vascularized composite allotransplantation (VCA) have been calcineurin inhibitor (CNI)-based. As such, most recipients have experienced CNI-related side effects. Costimulation blockade, specifically CD28/B7 inhibition with belatacept, has emerged as a clinical replacement for CNI-based immunosuppression in kidney transplantation. We have previously shown that belatacept can be used as a centerpiece immunosuppressant for VCA in nonhuman primates, and subsequently reported successful conversion from a CNI-based regimen to a belatacept-based regimen after clinical hand transplantation. We now report on the case of a hand transplant recipient, whom we have successfully treated with a de novo belatacept-based regimen, transitioned to a CNI-free regimen. This case demonstrates that belatacept can provide sufficient prophylaxis from rejection without chronic CNI-associated side effects, a particularly important goal in nonlifesaving solid organ transplants such as VCA.

Surviving critical illness: acute respiratory distress syndrome as experienced by patients and their caregivers.

OBJECTIVE: To characterize the effects of critical illness in the daily lives and functioning of acute respiratory distress syndrome survivors. Survivors of acute respiratory distress syndrome, a systemic critical illness, often report poor quality of life based on responses to standardized questionnaires. However, the experiences of acute respiratory distress syndrome survivors have not been reported. DESIGN: We conducted semistructured interviews with 23 acute respiratory distress syndrome survivors and 24 caregivers 3 to 9 mos after intensive care unit admission, stopping enrollment after thematic saturation was reached. Transcripts were analyzed, using Colaizzi's qualitative methodology, to identify significant ways in which survivors' critical illness experience impacted their lives. SETTING: Medical and surgical intensive care units of an academic medical center and a community hospital. PATIENTS: We recruited consecutively 31 acute respiratory distress syndrome survivors and their informal caregivers. Eight patients died before completing interviews. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Participants related five key elements of experience as survivors of acute respiratory distress syndrome: 1) pervasive memories of critical care; 2) day-to-day impact of new disability; 3) critical illness defining the sense of self; 4) relationship strain and change; and 5) ability to cope with disability. Survivors described remarkable disability that persisted for months. Caregivers' interviews revealed substantial strain from caregiving responsibilities as well as frequent symptom minimization by patients. CONCLUSIONS: The diverse and unique experiences of acute respiratory distress syndrome survivors reflect the global impact of severe critical illness. We have identified symptom domains important to acute respiratory distress syndrome patients who are not well represented in existing health outcomes measures. These insights may aid the development of targeted interventions to enhance recovery and return of function after acute respiratory distress syndrome.