Writing Committee for the REMAP-CAP Investigators IMPORTANCE The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive.OBJECTIVE To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. DESIGN, SETTING, AND PARTICIPANTSThe ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. INTERVENTIONSThe immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). MAIN OUTCOMES AND MEASURESThe primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, −1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events. RESULTS Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support-free days was 0 (IQR, -1 to 16) in the convalescent plasma group and 3 (IQR, -1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR <1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11...

Objective To investigate the effectiveness of foot orthoses for pain and function in adults with plantar heel pain.

ObjectiveTo compare the effectiveness of prefabricated foot orthoses to rocker‐sole footwear in reducing foot pain in people with first metatarsophalangeal (MTP) joint osteoarthritis (OA).MethodsParticipants (n = 102) with first MTP joint OA were randomly allocated to receive individualized, prefabricated foot orthoses or rocker‐sole footwear. The primary outcome measure was the pain subscale on the Foot Health Status Questionnaire (FHSQ) at 12 weeks. Secondary outcome measures included the function, footwear, and general foot health subscales of the FHSQ; the Foot Function Index; severity of pain and stiffness at the first MTP joint; perception of global improvement; general health status; use of rescue medication and co‐interventions to relieve pain; physical activity; and the frequency of self‐reported adverse events.ResultsThe FHSQ pain subscale scores improved in both groups, but no statistically significant difference between the groups was observed (adjusted mean difference 2.05 points, 95% confidence interval [95% CI] −3.61, 7.71; P = 0.477). However, the footwear group exhibited lower adherence (mean ± SD total hours worn 287 ± 193 versus 448 ± 234; P < 0.001), were less likely to report global improvement in symptoms (39% versus 62%; relative risk [RR] 0.63, 95% CI 0.41, 0.99; P = 0.043), and were more likely to experience adverse events (39% versus 16%; RR 2.47, 95% CI 1.12, 5.44; P = 0.024) compared to the orthoses group.ConclusionPrefabricated foot orthoses and rocker‐sole footwear are similarly effective at reducing foot pain in people with first MTP joint OA. However, prefabricated foot orthoses may be the intervention of choice due to greater adherence and fewer associated adverse events.

The aim of this study was to investigate the association between foot type and the morphometry of selected muscles and tendons of the lower limb. Sixty-one healthy participants (31 male, 30 female; aged 27.1 ± 8.8 years) underwent gray-scale musculoskeletal ultrasound examination to determine the anterior-posterior (AP) thickness of tibialis anterior, tibialis posterior, and peroneus longus muscles and tendons as well as the Achilles tendon. Foot type was classified based on arch height and footprint measurements. Potentially confounding variables (height, weight, hip and waist circumference, rearfoot and ankle joint range of motion, and levels of physical activity) were also measured. Multiple linear regression models were used to determine the association between foot type with muscle and tendon morphometry accounting for potentially confounding variables. Foot type was significantly and independently associated with AP thickness of the tibialis anterior tendon, peroneus longus muscle, and Achilles tendon, accounting for approximately 7% to 16% of the variation. Flat-arched feet were associated with a thicker tibialis anterior tendon, a thicker peroneus longus muscle, and a thinner Achilles tendon. Foot type is associated with morphometry of tendons that control sagittal plane motion of the rearfoot; and the peroneus longus muscle that controls frontal plane motion of the rearfoot. These findings may be related to differences in tendon loading during gait.

Background Foot orthoses have the potential to be an efficacious treatment for patellofemoral osteoarthritis (PFOA) but have not been evaluated in clinical trials in this population. This study aimed to determine the: (i) feasibility of conducting a randomised controlled trial (RCT) investigating the efficacy of foot orthoses in individuals with PFOA; and (ii) effects of foot orthoses versus flat shoe inserts on pain, function, and knee-related quality of life (QOL). Methods This 6-week, single-blinded pilot RCT randomly allocated participants with PFOA to receive foot orthoses or flat inserts. The primary outcome of feasibility was determined via the following parameters: one participant recruited per week, 20% (35 h/week) adherence to the intervention, 50% log book completion rate, and < 20% drop-out, with results reported using descriptive statistics. Secondary outcomes included average and maximum pain severity (100 mm visual analogue scale), Anterior Knee Pain Scale, and Knee injury and Osteoarthritis Outcome Score, analysed using analysis of covariance. Results Twenty-six participants (16 women; mean (SD) age of 60 (8) years) with PFOA were recruited. All feasibility parameters were exceeded, with three participants recruited per week, > 20% (37.2 [9.8] hours/week) adherence to the intervention, 69.2% (18/26) log-book completion, and 3.8% (1/26) drop-outs. The most common adverse events were arch irritation and shoe fit issues, which were more common in the foot orthoses group (67.9% versus 32.1%). There was a trend for the foot orthoses group to report larger improvements in average and maximum pain than the flat insert group, with the mean difference for maximum knee pain severity (21.9 mm, 95% CI − 2.1 to 46.0) exceeding the minimal clinically important difference (15 mm). The estimated sample size for a full-scale RCT is 160 participants. Suggestions to improve study design include a greater number of face-to-face follow-up appointments, a larger variety of foot orthoses to reduce rates of adverse events, and increasing follow-up time to determine long-term efficacy. Conclusion This study supports the feasibility of a full-scale RCT to determine the efficacy of foot orthoses versus flat inserts in individuals with PFOA. Trial registration The trial protocol was retrospectively registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR number: 12616001287426 ).