A Randomized Double-Blind Placebo-Control Feasibility Trial of Immunoglobulin Treatment for Prevention of Recurrent Acute Exacerbations of COPD.

BACKGROUND: Observational studies suggest that immunoglobulin treatment may reduce the frequency of acute exacerbations of COPD (AECOPD). OBJECTIVE: To inform the design of a future randomised control trial (RCT) of intravenous immunoglobulin (IVIG) treatment efficacy for AECOPD prevention. METHODS: A pilot RCT was conducted. We recruited patients with COPD hospitalized for AECOPD, or from ambulatory clinics with one severe, or two moderate AECOPD in the previous year regardless of their serum IgG level. Patients were allocated in a 1:1 ratio with balanced randomisation to monthly IVIG or normal saline for 1 year. The primary outcome was feasibility defined as pre-specified accrual, adherence, and follow-up rates. Secondary outcomes included safety, tolerance, AECOPD rates, time to first AECOPD, quality of life, and healthcare costs. RESULTS: Seventy patients were randomized (37 female; mean age 67.7; mean FEV1 35.1%). Recruitment averaged 4.5±0.9 patients per month (range 0-8), 34 (49%) adhered to at least 80% of planned treatments, and four (5.7%) were lost to follow-up. There were 35 serious adverse events including seven deaths and one thromboembolism. None was related to IVIG. There were 56 and 48 moderate and severe AECOPD in the IVIG vs control groups. In patients with at least 80% treatment adherence, median time to first moderate or severe AECOPD was 275 vs 114 days, favoring the IVIG group (HR 0.76, 95% CI 0.3-1.92). CONCLUSION: The study met feasibility criteria for recruitment and retention, but adherence was low. A trend toward more robust treatment efficacy in adherent patients supports further study, but future trials must address treatment adherence. TRIAL REGISTRATION NUMBER: NCT0290038, registered 24 February 2016, https://clinicaltrials.gov/ct2/show/NCT02690038 and NCT03018652, registered January 12, 2017, https://clinicaltrials.gov/ct2/show/NCT03018652.

Participation-focused interventions for stroke rehabilitation: a scoping review protocol.

OBJECTIVE: The objectives of this scoping review are to i) identify adaptive stroke rehabilitation interventions using metacognitive or self-management approaches targeting participation as an outcome; ii) determine the explicit and implicit theories underlying these interventions; and iii) ascertain the elements in each intervention. This review will develop a catalogue of these interventions, improving the understanding of how these interventions work, thereby facilitating efficient development and testing of participation-focused interventions. INTRODUCTION: Stroke rehabilitation interventions can be categorized as those aiming to correct impairment and those seeking participation improvement despite impairment. Impairment-focused interventions include a relatively small number of well-defined elements, generally based on motor learning or other types of learning theory. Participation-focused interventions span a large group of diverse interventions. The underlying theory is typically varied and often implicit, but many of these interventions are based on metacognitive or self-management approaches. An examination of the underlying theory and elements of participation-focused interventions would allow researchers to more effectively advance the science of these approaches. INCLUSION CRITERIA: The review will include published papers describing rehabilitation interventions using metacognitive or self-management approaches to improve participation among adults who have experienced a stroke. METHODS: The search will include JBI Evidence-Based Practice Database, MEDLINE, Embase, CINAHL, PsycINFO, OTSeeker, and PEDro databases. Studies will be selected according to a three-step process, including i) managing search results and removing duplicates, ii) title and abstract screening, and iii) full text screening. The extracted data will be presented in table form and narrative summary, aligning with the objectives and scope of this review.

False positives in functional near-infrared topography.

Functional cranial near-infrared spectroscopy (NIRS) has been widely used to investigate the haemodynamic changes which occur in response to functional activation. The technique exploits the different absorption spectra of oxy- and deoxy-haemoglobin ([HbO2] [HHb]) in the near-infrared region to measure the changes in oxygenation and haemodynamics in the cortical tissue. The aim of this study was to use an optical topography system to produce topographic maps of the haemodynamic response of both frontal cortex (FC) and motor cortex (MC) during anagram solving while simultaneously monitoring the systemic physiology (mean blood pressure, heart rate, scalp flux). A total of 22 young healthy adults were studied. The activation paradigm comprised of 4-, 6- and 8- letter anagrams. 12 channels of the optical topography system were positioned over the FC and 12 channels over the MC. During the task 12 subjects demonstrated a significant change in at least one systemic variable (p < or = 0.05). Statistical analysis of task-related changes in [HbO2] and [HHb], based on a Student's t-test was insufficient to distinguish between cortical haemodynamic activation and systemic interference. This lead to false positive haemodynamic maps of activation. It is therefore necessary to use statistical testing that incorporates the systemic changes that occur during brain activation.