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...

Lean thinking is a method for organising complex production processes so as to encourage flow and reduce waste. While the principles of lean thinking were developed in the manufacturing sector, there is increasing interest in its application in health care. This case history documents the introduction and development of Redesigning Care, a lean thinking-based program to redesign care processes across a teaching general hospital. Redesigning Care has produced substantial benefits over the first two-and-a-half years of its implementation, making care both safer and more accessible. Redesigning Care has not been aimed at changing the specifics of clinical practice. Rather, it has been concerned with improving the flow of patients through clinical and other systems. Concepts that emerged in the manufacturing sector have been readily translatable into health care. Lean thinking may play an important role in the reform of health care in Australia and elsewhere.

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Introduction The South Australian Couples Sildenafil (SACS) study sought to look more closely at the role of sexual functioning in couples by exploring the impact of treatment for erectile dysfunction (ED) with sildenafil. Aim The SACS study investigated the individual and dyadic impact of the drug sildenafil (Viagra) on couples over a 6-month period. Main Outcome Measures A range of outcome measures were utilized including the Dyadic Adjustment Scale (DAS), the International Index of Erectile Function (IIEF), and the Erectile Dysfunction Inventory of Treatment Satisfaction. Methods Couples were recruited through the use of local media and general practitioners. Couples were randomly allocated to placebo or active drug with the option of using up to one study tablet per day for 6 months. Couples were reviewed at 2 weeks, 4 weeks, 8 weeks, 3 months, and 6 months. Results There were 108 couples who were eligible for the study with the eventual analysis including 49 couples in the active treatment group and 47 in the placebo group with similar demographic and background profiles found in both groups. A large number of psychosocial, quality-of-life, and sexual measures were recorded at the end of the trial for both male subjects and their female partners. Predictably, the erectile response in the active treatment group showed a significant improvement as measured by the IIEF although no change was found between the active and placebo groups in relationship functioning as measured by the DAS scores. Conclusions The SACS study found no difference between treatment arms with regard to relationship functioning after the use of sildenafil for ED. Potential contributing factors to a “no change” result are discussed. The SACS study adds to the available literature on psychological and interpersonal factors in the treatment of ED which have not been sufficiently investigated until recently.

Acute and chronic pain in trauma patients remains a challenging entity, particularly in the setting of the escalating opioid epidemic. It has been reported that chronic opioid use increases the likelihood of hospital admissions as a result of traumatic injuries. Furthermore, patients admitted with traumatic injuries have a greater than average risk of developing opioid use disorder after discharge. Practitioners providing care to these patients will encounter the issue of balancing analgesic goals and acute opioid withdrawal with the challenge of reducing postdischarge persistent opioid use. Additionally, the practitioner is faced with the worrisome prospect that inadequate treatment of acute pain may lead to the development of chronic pain and overtreatment may result in opioid dependence. It is therefore imperative to understand and execute alternative nonopioid strategies to maximize the benefits and reduce the risks of analgesic regimens in this patient population. This narrative review will analyze the current literature on pain management in trauma patients and highlight the application of the multimodal approach in potentially reducing the risks of both short- and long-term opioid use. LEVEL OF EVIDENCE Narrative review, moderate to High.

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