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...
SUMMARY Forty four children with daytime wetting were included in a randomly controlled trial of two alarm devices, a contingent one that sounded when wetting occurred and a non-contingent one that went off from time to time unrelated to wetting events. A quota allocation system ensured comparability between treatment groups. Two thirds responded to an alarm by becoming dry. The non-contingent alarm produced as good a response as the contingent one and is recommended for routine use in children with diurnal enuresis. Twenty three per cent of those who responded to treatment relapsed up to two years after completion of the trial. This study was set up to evaluate a contingent alarm system for the treatment of diurnal enuresis using a randomly controlled trial. Children who did not receive the device being tested were managed with what seemed to be an identical alarm but which in fact merely emitted a similar loud tone about every two hours, whether wetting had occurred or not. Patients and methodsChildren aged 5 to 15 attending a children's enuresis clinic were selected for inclusion in the trial.Daytime wetting had to be sufficiently common and severe to make it the main problem complained about by the mother. For most of the children the pants became so wet each day that urine soaked through to trousers or skirt; it was rare, however, for there to be a puddle on the chair seat or floor.About two thirds of the children were referred by consultant colleagues (tertiary referral) and the other third by general practitioners or clinical medical officers. Any children identified as having severe urinary tract abnormality were excluded; urinary tract infections were treated before the child was included in the study. Children with very severe social or psychological problems that made them unsuitable for routine management in a paediatric outpatient clinic were also excluded. Nevertheless, the sample of cases included in the study was virtually a consecutive series of children presenting with troublesome daytime wetting; only two were excluded because of being too disturbed for paediatric management.Fifty cases were collected, but in one instance the family refused to participate, in another the child developed diabetes mellitus, and for four others treatment was not thought to be necessary as there was a period of at least seven days without wetting during the baseline period. Therefore, 44 children were included in the trial and allocated to one of the two treatment groups. The mean (SD) age of those included was 8-5
We aimed to quantify declines from baseline in lower limb skeletal muscle size and strength of uninjured adults following single‐leg disuse. We searched EMBASE, Medline, CINAHL, and CCRCT up to 30 January 2022. Studies were included in the systematic review if they (1) recruited uninjured participants; (2) were an original experimental study; (3) employed a single‐leg disuse model; and (4) reported muscle strength, size, or power data following a period of single‐leg disuse for at least one group without a countermeasure. Studies were excluded if they (1) did not meet all inclusion criteria; (2) were not in English; (3) reported previously published muscle strength, size, or power data; or (4) could not be sourced from two different libraries, repeated online searches, and the authors. We used the Cochrane Risk of Bias Assessment Tool to assess risk of bias. We then performed random‐effects meta‐analyses on studies reporting measures of leg extension strength and extensor size. Our search revealed 6548 studies, and 86 were included in our systematic review. Data from 35 and 20 studies were then included in the meta‐analyses for measures of leg extensor strength and size, respectively (40 different studies). No meta‐analysis for muscle power was performed due to insufficient homogenous data. Effect sizes (Hedges' gav) with 95% confidence intervals for leg extensor strength were all durations = −0.80 [−0.92, −0.68] (n = 429 participants; n = 68 aged 40 years or older; n ≥ 78 females); ≤7 days of disuse = −0.57 [−0.75, −0.40] (n = 151); >7 days and ≤14 days = −0.93 [−1.12, −0.74] (n = 206); and >14 days = −0.95 [−1.20, −0.70] (n = 72). Effect sizes for measures of leg extensor size were all durations = −0.41 [−0.51, −0.31] (n = 233; n = 32 aged 40 years or older; n ≥ 42 females); ≤7 days = −0.26 [−0.36, −0.16] (n = 84); >7 days and ≤14 days = −0.49 [−0.67, −0.30] (n = 102); and >14 days = −0.52 [−0.74, −0.30] (n = 47). Decreases in leg extensor strength (cast: −0.94 [−1.30, −0.59] (n = 73); brace: −0.90 [−1.18, −0.63] (n = 106)) and size (cast: −0.61[−0.87, −0.35] (n = 41); brace: (−0.48 [−1.04, 0.07] (n = 41)) following 14 days of disuse did not differ for cast and brace disuse models. Single‐leg disuse in adults resulted in a decline in leg extensor strength and size that reached a nadir beyond 14 days. Bracing and casting led to similar declines in leg extensor strength and size following 14 days of disuse. Studies including females and males and adults over 40 years of age are lacking.
The paper describes the use of a Digital Rainbow computer for organising, listing, displaying and retrospectively storing records of journals sent for binding at Sunderland Polytechnic Library. It touches briefly on the problems of the old manual system, and on the general difficulties of establishing a binding policy. The paper goes on to describe the creation of the main database files, and the command files which produce lists for the binders, integrated informative lists of all material away at a time, and lists of journals not bound. Also described is the creation of separate disks and files for retrospective storing of binding of records. The results are twofold: a more informative and efficient system of recording binding issues has been produced; and the automated system has generated the formation of a comprehensive binding policy.
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