Rationale for integration of palliative care in the medical intensive care: A narrative literature review

Despite the remarkable technological advancement in the arena of critical care expertise, the mortality of critically ill patients remains high. When the organ functions deteriorate, goals of care are not fulfilled and life-sustaining treatment becomes a burden on the patient and caregivers, then it is the responsibility of the physician to provide a dignified end to life, control the symptoms of the patient and provide psychological support to the family members. Palliative care is the best way forward for these patients. It is a multidimensional specialty which emphasizes patient and family-based care and aims to improve the quality of life of patients and their caregivers. Although intensive care and palliative care may seem to be at two opposite ends of the spectrum, it is necessary to amalgamate the postulates of palliative care in intensive care units to provide holistic care and best benefit patients admitted to intensive care units. This review aims to highlight the need for an alliance of palliative care with intensive care in the present era, the barriers to it, and models proposed for their integration and various ethical issues.     

Optimizing telemedicine to facilitate amyotrophic lateral sclerosis clinical trials

Amyotrophic lateral sclerosis (ALS) has the largest drug pipeline among neuromuscular diseases, with over 160 companies actively involved in ALS research. There is a growing need to recruit trial participants, but ALS patients often have limited mobility and most ALS trials are conducted in a small number of major centers. These factors effectively limit patient participation, particularly for those in rural areas. The current coronavirus disease 2019 (COVID-19) pandemic has necessitated the more widespread use of telemedicine technology for clinical care, and has prompted consideration of its increased use for clinical trials. In this opinion piece, we describe the current state of telemedicine for recruitment, consenting, and screening of participants for clinical trials. We also summarize the available data on remote administration of outcome measures. Current challenges include validation of outcome measures for remote assessment, as well as technological, regulatory, and licensure barriers.     

Discrepancies in endpoints between clinical trial protocols and clinical trial registration in randomized trials in oncology

Background

Clinical trials are an essential part of evidence-based medicine. Hence, to ensure transparency and accountability in these clinical trials, policies for registration have been framed with emphasis on mandatory submission of trial elements, specifically outcome measures. As these efforts evolve further, we sought to evaluate the current status of endpoint reporting in clinical trial registries.

Methods

We reviewed 71 oncology related randomized controlled trials published in three high impact journals. We compared primary (PEP) and non-primary endpoints (NPEP) between the clinical trial protocols of these trials and their corresponding registration in one of the 14 primary global clinical trial registries. A discrepancy was defined as the non-reporting or absence of an endpoint in either the protocol or registry. The primary endpoint was the rate of discrepancy between secondary endpoints in clinical trial protocols and clinical trial registries.

Results

Of the 71 clinical trials, a discrepancy in PEP was found in only 4 trials (6%). Secondary endpoint (SEP) differences were found in 45 (63%) trials. Among these 45 trials, 36 (80%) had SEPs that were planned in the protocol but not reported in the registry and 19 (42%) had SEPs with endpoints in the registry that were not found in the protocol. The total number of SEPs that were absent from the corresponding registry and protocol were 84 and 29, respectively. Of these endpoints, 48 (57%) and 9 (31%) were included in the published report of these trials.

Conclusion

Although recent regulations and enhanced procedures have improved the number and quality of clinical trial registrations, inconsistencies regarding endpoint reporting still exist. Though further guidelines for the registration of clinical trials will help, greater efforts to provide a correct, easily accessible, and complete representation of planned endpoints are needed.

     

Using a Novel <Emphasis Type="Italic">In Vitro</Emphasis> Fontan Model and Condition-Specific Real-Time MRI Data to Examine Hemodynamic Effects of Respiration and Exercise

Several studies exist modeling the Fontan connection to understand its hemodynamic ties to patient outcomes (Chopski in: Experimental and Computational Assessment of Mechanical Circulatory Assistance of a Patient-Specific Fontan Vessel Configuration. Dissertation, 2013; Khiabani et al. in J Biomech 45:2376–2381, 2012; Taylor and Figueroa in Annu Rev Biomed 11:109–134, 2009; Vukicevic et al. in ASAIO J 59:253–260, 2013). The most patient-accurate of these studies include flexible, patient-specific total cavopulmonary connections. This study improves Fontan hemodynamic modeling by validating Fontan model flexibility against a patient-specific bulk compliance value, and employing real-time phase contrast magnetic resonance flow data. The improved model was employed to acquire velocity field information under breath-held, free-breathing, and exercise conditions to investigate the effect of these conditions on clinically important Fontan hemodynamic metrics including power loss and viscous dissipation rate. The velocity data, obtained by stereoscopic particle image velocimetry, was visualized for qualitative three-dimensional flow field comparisons between the conditions. Key hemodynamic metrics were calculated from the velocity data and used to quantitatively compare the flow conditions. The data shows a multi-factorial and extremely patient-specific nature to Fontan hemodynamics.     

Foreign body in ocular coats causing a pseudo optic nerve head shadow

Small intraocular foreign body in the outer coats of the eye may be wrongly interpreted as optic nerve head on ultrasound imaging. Such errors can be avoided by performing multiple sonography scans in different axes.     

Guidelines for ethical behavior relating to clinical practice issues in neuromuscular and electrodiagnostic medicine

The American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) developed guidelines to formalize the ethical standards that neuromuscular and electrodiagnostic (EDx) physicians should observe in their clinical and scientific activities. Neuromuscular and EDx medicine is a subspecialty of medicine that focuses on evaluation, diagnosis, and comprehensive medical management, including rehabilitation of individuals with neuromuscular disorders. Physicians working in this subspecialty focus on disorders of the motor unit, including muscle, neuromuscular junction, axon, plexus, nerve root, anterior horn cell, and the peripheral nerves (motor and sensory). The neuromuscular and EDx physician's goal is to diagnose and treat these conditions to mitigate their impact and improve the patient's quality of life. The guidelines are consistent with the Principles of Medical Ethics adopted by the American Medical Association and represent a revision of previous AANEM guidelines. Muscle Nerve 52 : 1122–1129, 2015