American Association for the Surgery of Trauma/American College of Surgeons Committee on Trauma: Clinical protocol for damage-control resuscitation for the adult trauma patient.

ABSTRACT: Damage-control resuscitation in the care of critically injured trauma patients aims to limit blood loss and prevent and treat coagulopathy by combining early definitive hemorrhage control, hypotensive resuscitation, and early and balanced use of blood products (hemostatic resuscitation) and the use of other hemostatic agents. This clinical protocol has been developed to provide evidence-based recommendations for optimal damage-control resuscitation in the care of trauma patients with hemorrhage.

Standardization of Trauma, General Surgical Morbidity and Mortality Conferences: Development and Dissemination of a "Toolkit" in Peru.

BACKGROUND: Morbidity and Mortality (M&M) conferences allow clinicians to review adverse events and identify areas for improvement. There are few reports of structured M&M conferences in low- and middle-income countries and no report of collaborative efforts to standardize them. METHODS: The present study aims to gather general surgeons representing most of Peru's urban surgical care and, in collaboration, with trauma quality improvement experts develop a M&M conferences toolkit with the expectation that its diffusion impacts their reported clinical practice. Fourteen general surgeons developed a toolkit as part of a working group under the auspices of the Peruvian General Surgery Society. After three years, we conducted an anonymous written questionnaire to follow-up previous observations of quality improvement practices. RESULTS: A four-component toolkit was developed: Toolkit component #1: Conference logistics and case selection; Toolkit component #2: Documenting form; Toolkit component #3: Presentation template; and Toolkit component #4: Code of conduct. The toolkit was disseminated to 10 hospitals in 2016. Its effectiveness was evaluated by comparing the results of surveys on quality improvement practices conducted in 2016, before toolkit dissemination (101 respondents) and 2019 (105 respondents). Lower attendance was reported by surgeons in 2019. However, in 2019, participants more frequently described "improve the system" as the perceived objective of M&M conferences (70.5% vs. 38.6% in 2016; p < 0.001). CONCLUSION: We established a toolkit for the national dissemination of a standardized M&M conference. Three years following the initial assessment in Peru, we found similar practice patterns except for increased reporting of "system improvement" as the goal of M&M conferences.

Changes in error patterns in unanticipated trauma deaths during 20 years: In pursuit of zero preventable deaths.

BACKGROUND: A fundamental goal of continuous process improvement programs is to evaluate and improve the ratio of actual to expected mortality. To study this, we examined contributors to error-associated deaths during two consecutive periods from 1996 to 2004 (period 1) and 2005 to 2014 (period 2). METHODS: All deaths at a level I trauma center with an anticipated probability of death less than 50% and/or identified through process improvement committees were examined. Demographics were assessed for trend only because period 1 data were only available in median and interquartile range. Each death was critically appraised to identify potential error, with subsequent classification of error type, phase, cause, and contributing cognitive processes, with comparison of outcomes made using χ test of independence. RESULTS: During period 1, there were a total of 44,401 admissions with 2,594 deaths and 64 deaths (2.5%) associated with an error, compared with 60,881 admissions during period 2 with 2,659 deaths and 77 (2.9%) associated with an error. Deaths associated with an error occurred in younger and less severely injured patients in period 1 and were likely to occur during the early phase of care, primarily from failed resuscitation and hemorrhage control. In period 2, deaths occurred in older more severely injured patients and were likely to occur in the later phase of care primarily because of respiratory failure from aspiration. CONCLUSION: Despite injured patients being older and more severely injured, error-associated deaths during the early phase of care that was associated with hemorrhage improved over time. Successful implementation of system improvements resolved issues in the early phase of care but shifted deaths to later events during the recovery phase including respiratory failure from aspiration. This study demonstrates that ongoing evaluation is essential for continuous process improvement and realignment of efforts, even in a mature trauma system. LEVEL OF EVIDENCE: Therapeutic/Care Management, level IV.

Effect of Standardized Handoff Curriculum on Improved Clinician Preparedness in the Intensive Care Unit: A Stepped-Wedge Cluster Randomized Clinical Trial.

Importance: Clinician miscommunication contributes to an estimated 250 000 deaths in US hospitals per year. Efforts to standardize handoff communication may reduce errors and improve patient safety. Objective: To determine the effect of a standardized handoff curriculum, UW-IPASS, on interclinician communication and patient outcomes. Design, Setting, and Participants: This cluster randomized stepped-wedge randomized clinical trial was conducted from October 2015 to May 2016 at 8 medical and surgical intensive care units at 2 hospital systems within an academic tertiary referral center. Participants included residents, fellows, advance-practice clinicians, and attending physicians (n = 106 clinicians, with 1488 handoff events over 8 months) and data were collected from daily text message-based surveys and patient medical records. Exposures: The UW-IPASS standardized handoff curriculum. Main Outcomes and Measures: The primary aim was to assess the effect of the UW-IPASS handoff curriculum on perceived adequacy of interclinician communication. Patient days of mechanical ventilation, intensive care unit length of stay, reintubations within 24 hours, and order workflow patterns were also analyzed. Mixed-effects logistic regression was used to compute odds ratios and confidence intervals with adjustment for location, time period, and clinician. Results: A total of 63 residents and advance practice clinicians, 13 fellows, and 30 attending physicians participated in the study. During the control period, clinicians reported being unprepared for their shift because of a poor-quality handoff in 35 of 343 handoffs (10.2%), while UW-IPASS-period residents reported being unprepared in 53 of 740 handoffs (7.2%) (odds ratio, 0.19; 95% CI, 0.03-0.74; P = .03). Compared with the control phase, the perceived duration of handoffs among clinicians using UW-IPASS was unchanged (+5.5 minutes; 95% CI, 0.34-9.39; P = .30). Early morning order entry decreased from 106 per 100 patient-days in the control phase to 78 per 100 patient-days in the intervention period (-28 orders; 95% CI, -55 to -4; P = .04). Overall, UW-IPASS was not associated with any changes in intensive care unit length of stay, duration of mechanical ventilation, or the number of reintubations. Conclusions and Relevance: The UW-IPASS standardized handoff curriculum was perceived to improve intensive care provider preparedness and workflow. IPASS-based curricula represent an important step forward in communication standardization efforts and may help reduce communication errors and omissions. Trial Registration: isrctn.org Identifier: ISRCTN14209509.

A Global Assessment of Access to and Use of Medical Information: The State of Evidence-Based Surgery.

BACKGROUND: We aimed to assess surgeons' access to and use of medical information, as well as their training and perceptions about evidence-based medicine (EBM), in order to identify priority areas for improvement. STUDY DESIGN: An anonymous survey conducted among surgeons from the USA, Ghana, Peru, and Thailand examined access to, and use and perception of, medical literature. RESULTS: Of 307 participants, 98% reported access to "OK" or "good" internet. Fifty-one percent reported that language was a barrier to accessing needed medical information; most frequently in Peru (73%) and Thailand (64%). Access to priced full-text journals was poorest in Peru, where 54% lacked access, followed by Ghana (42%) and Thailand (32%). US respondents scored highest on the EBM knowledge test (1.4, SD 0.8), followed by Thailand (1.3, SD 0.9), Ghana (1.1, SD 0.8), and Peru (0.9, SD 0.8) (p < 0.001). Adjusted analysis revealed Ghanaians and Peruvians spent 5% and 1% more on medical information, respectively, relative to country income, than persons from other countries (p < 0.01). After adjustment, employment in a large and/or urban hospital and history of EBM training were associated with better EBM test scores, while middle-income origin and public hospital employment were associated with worse scores (p < 0.05). CONCLUSION: Language, access to priced full-text journals, and training are significant barriers to surgeons' practice of EBM globally. The way forward involves collaboration among surgical societies, publishers, hospital employers, and international policymakers in providing surgeons from all country income levels with the access and training necessary to interpret and apply medical information.

Assessment of Rehabilitation Infrastructure in Peru.

OBJECTIVE: To assess rehabilitation infrastructure in Peru in terms of the World Health Organization (WHO) health systems building blocks. DESIGN: Anonymous quantitative survey; questions were based on the WHO's Guidelines for Essential Trauma Care and rehabilitation professionals' input. SETTING: Large public hospitals and referral centers and an online survey platform. PARTICIPANTS: Convenience sample of hospital personnel working in rehabilitation and neurology (N=239), recruited through existing contacts and professional societies. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Outcome measures were for 4 WHO domains: health workforce, health service delivery, essential medical products and technologies, and health information systems. RESULTS: Regarding the domain of health workforce, 47% of physical therapists, 50% of occupational therapists, and 22% of physiatrists never see inpatients. Few reported rehabilitative nurses (15%) or prosthetist/orthotists (14%) at their hospitals. Even at the largest hospitals, most reported ≤3 occupational therapists (54%) and speech-language pathologists (70%). At hospitals without speech-language pathologists, physical therapists (49%) or nobody (34%) perform speech-language pathology roles. At hospitals without occupational therapists, physical therapists most commonly (59%) perform occupational therapy tasks. Alternate prosthetist/orthotist task performers are occupational therapists (26%), physical therapists (19%), and physicians (16%). Forty-four percent reported interdisciplinary collaboration. Regarding the domain of health services, the most frequent inpatient and outpatient rehabilitation barriers were referral delays (50%) and distance/transportation (39%), respectively. Regarding the domain of health information systems, 28% reported rehabilitation service data collection. Regarding the domain of essential medical products and technologies, electrophysical agents (88%), gyms (81%), and electromyography (76%) were most common; thickened liquids (19%), swallow studies (24%), and cognitive training tools (28%) were least frequent. CONCLUSIONS: Rehabilitation emphasis is on outpatient services, and there are comparatively adequate numbers of physical therapists and physiatrists relative to rehabilitation personnel. Financial barriers seem low for accessing existing services. There appear to be shortages of inpatient rehabilitation, specialized services, and interdisciplinary collaboration. These may be addressed by redistributing personnel and investing in education and equipment for specialized services. Further examination of task sharing's role in Peru's rehabilitation services is necessary to evaluate its potential to address deficiencies.

Correction to: A Global Assessment of Access to and Use of Medical Information: The State of Evidence-Based Surgery.

In the original article some funding information was inadvertently omitted. The complete funding information is as follows.

Status of trauma quality improvement programs in the Americas: a survey of trauma care providers.

INTRODUCTION: Global disparities in trauma care contribute to significant morbidity and mortality (M&M) in low- and middle-income countries. Implementation of quality improvement (QI) programs has been shown to be a cost-effective strategy to improve trauma care quality. In this study, we aim to characterize the trauma QI programs in a broad range of low- to high-income countries in the Americas to assess areas for targeted improvement in global trauma QI efforts. METHODS: We conducted a mixed methods survey of trauma care providers in North and South America distributed in-person at trauma care conferences and online via a secure survey platform. Responses were analyzed to observe differences across respondent country income categories. RESULTS: One hundred ninety-two surveys were collected, representing 21 different countries from three income strata (three lower-middle-, eleven upper-middle-, and eight high-income countries). Respondents were primarily physicians or physicians-in-training (85%). Eighty-nine percent of respondents worked at an institution where M&M conferences occurred. M&M conferences were significantly more frequent at higher income levels (P = 0.002), as was attending physician presence at M&M conferences (70% in high-income countries versus 43% in lower-middle-income countries). There were also significant differences in the structure, quality, and follow-up of M&M conferences in lower versus higher income countries. Sixty-three percent of respondents reported observing some kind of positive change at their institution due to M&M conferences. The survey also suggested significantly higher utilization of autopsy (P < 0.001) and electronic trauma registries (P = 0.01) at higher income levels. CONCLUSIONS: This survey demonstrated an encouraging pattern of widespread adoption of trauma QI programs in several countries in North and South America. However, there continue to be significant disparities in the structure and function of trauma QI efforts in low- and middle-income countries in the Americas. There are several potential areas for development and improvement of trauma care systems, including standardization of case selection and follow-up for M&M conferences and increased use of medical literature to improve evidence-based care.

Status of trauma quality improvement programs in the Andean region: What foundation do we have to build on.

INTRODUCTION: Trauma quality improvement (QI) programs have been shown to improve outcomes and decrease cost. These are high priorities in low- and middle-income countries (LMICs), where 2,000,000 deaths due to survivable injuries occur each year. We sought to define areas for improvement in trauma QI programs in four LMICs. METHODS: We conducted a survey among trauma care providers in four Andean middle-income countries: Bolivia, Colombia, Ecuador, and Peru. RESULTS: 336 physicians, medical students, nurses, administrators and paramedical professionals responded to the cross-sectional survey with a response rate greater than 90% in all included countries except Bolivia, where the response rate was 14%. Eighty-seven percent of respondents reported morbidity and mortality (M&M) conferences occur at their hospital. Conferences were often reported as infrequent - 45% occurred less than every three months and poorly attended - 63% had five or fewer staff physicians present. Only 23% of conferences had standardized selection criteria, most lacked documentation - notes were taken at only 35% of conferences. Importantly, only 13% of participants indicated that discussions were routinely followed-up with any sort of corrective action. Multivariable analysis revealed the presence of standardized case selection criteria (OR 3.48, 95% CI 1.16-10.46), written documentation of the M&M conferences (OR 5.73, 95% CI 1.73-19.06), and a clear plan for follow-up (OR 4.80, 95% CI 1.59-14.50) to be associated with effective M&M conferences. Twenty-two percent of respondents worked at hospitals with a trauma registry. Fifty-two percent worked at institutions where autopsies were conducted, but only 32% of those reported the autopsy results to ever be used to improve hospital practice. CONCLUSIONS: M&M conferences are frequently practiced in the Andean region of Latin America but often lack methodologic rigor and thus effectiveness. Next steps in the maturation of QI programs include optimizing use of data from autopsies and registries, and systematic follow-up of M&M conferences with corrective action to ensure that these activities result in appreciable changes in clinical care.

Mixed-Methods Assessment of Trauma and Acute Care Surgical Quality Improvement Programs in Peru.

BACKGROUND: Evidence for the positive impact of quality improvement (QI) programs on morbidity, mortality, patient satisfaction, and cost is strong. Data regarding the status of QI programs in low- and middle-income countries, as well as in-depth examination of barriers and facilitators to their implementation, are limited. METHODS: This cross-sectional, descriptive study employed a mixed-methods design, including distribution of an anonymous quantitative survey and individual interviews with healthcare providers who participate in the care of the injured at ten large hospitals in Lima, Peru. RESULTS: Key areas identified for improvement in morbidity and mortality (M&M) conferences were the standardization of case selection, incorporation of evidence from the medical literature into case presentation and discussion, case documentation, and the development of a clear plan for case follow-up. The key barriers to QI program implementation were a lack of prioritization of QI, lack of sufficient human and administrative resources, lack of political support, and lack of education on QI practices. CONCLUSIONS: A national program that makes QI a required part of all health providers' professional training and responsibilities would effectively address a majority of identified barriers to QI programs in Peru. Specifically, the presence of basic QI elements, such as M&M conferences, should be required at hospitals that train pre-graduate physicians. Alternatively, short of this national-level organization, efforts that capitalize on local examples through apprenticeships between institutions or integration of QI into continuing medical education would be expected to build on the facilitators for QI programs that exist in Peru.

Surgeons' and Trauma Care Physicians' Perception of the Impact of the Globalization of Medical Education on Quality of Care in Lima, Peru.

Importance: The globalization of medical education-the process by which trainees in any region gain access to international training (electronic or in-person)-is a growing trend. More data are needed to inform next steps in the responsible stewardship of this process, from the perspective of trainees and institutions at all income levels, and for use by national and international policymakers. Objective: To describe the impact of the globalization of medical education on surgical care in Peru from the perspective of Peruvian surgeons who received international training. Design, Setting, and Participants: Observational study of qualitative interviews conducted from September 2015 to January 2016 using grounded theory qualitative research methods. The study was conducted at 10 large public institutions that provide most of the trauma care in Lima, Peru, and included urban resident and faculty surgery and trauma care physicians. Exposures: Access to international surgical rotations and medical information. Main Outcomes and Measures: Outcome measures defining the impact of globalization on surgical care were developed as part of simultaneous data collection and analysis during qualitative research as part of a larger project on trauma quality improvement practices in Peru. Results: Fifty qualitative interviews of surgeons and emergency medicine physicians were conducted at 10 hospitals, including multiple from the public and social security systems. A median of 4 interviews were conducted at each hospital, and fewer than 3 interviews were conducted at only 1 hospital. From the broader theme of globalization emerged subthemes of an eroded sense of agency and a perception of inadequate training on the adaptation of international standards as negative effects of globalization on surgical care in Peru. Access to research funds, provision of incentives for acquisition of advanced clinical training, increased expectations for patient outcomes, and education in quality improvement skills are ways in which globalization positively affected surgeons and their patients in Peru. Conclusions and Relevance: Short-term overseas training of surgeons from low- and middle-income countries may improve care in the surgeons' country of origin through the acquisition of skills and altered expectations for excellence. Prioritization of evidence-based medical education is necessary given widespread internet access and thus clinician exposure to variable quality medical information. Finally, the establishment of centers of excellence in low- and middle-income countries may address the eroded sense of agency attributable to globalization and offer a local example of world-class surgical outcomes, diminishing surgeons' most frequently cited reason for emigration: access to better surgical training.

Antibiotics as part of the management of severe acute malnutrition.

BACKGROUND: Severe acute malnutrition contributes to 1 million deaths among children annually. Adding routine antibiotic agents to nutritional therapy may increase recovery rates and decrease mortality among children with severe acute malnutrition treated in the community. METHODS: In this randomized, double-blind, placebo-controlled trial, we randomly assigned Malawian children, 6 to 59 months of age, with severe acute malnutrition to receive amoxicillin, cefdinir, or placebo for 7 days in addition to ready-to-use therapeutic food for the outpatient treatment of uncomplicated severe acute malnutrition. The primary outcomes were the rate of nutritional recovery and the mortality rate. RESULTS: A total of 2767 children with severe acute malnutrition were enrolled. In the amoxicillin, cefdinir, and placebo groups, 88.7%, 90.9%, and 85.1% of the children recovered, respectively (relative risk of treatment failure with placebo vs. amoxicillin, 1.32; 95% confidence interval [CI], 1.04 to 1.68; relative risk with placebo vs. cefdinir, 1.64; 95% CI, 1.27 to 2.11). The mortality rates for the three groups were 4.8%, 4.1%, and 7.4%, respectively (relative risk of death with placebo vs. amoxicillin, 1.55; 95% CI, 1.07 to 2.24; relative risk with placebo vs. cefdinir, 1.80; 95% CI, 1.22 to 2.64). Among children who recovered, the rate of weight gain was increased among those who received antibiotics. No interaction between type of severe acute malnutrition and intervention group was observed for either the rate of nutritional recovery or the mortality rate. CONCLUSIONS: The addition of antibiotics to therapeutic regimens for uncomplicated severe acute malnutrition was associated with a significant improvement in recovery and mortality rates. (Funded by the Hickey Family Foundation and others; ClinicalTrials.gov number, NCT01000298.).

Assessment of trauma quality improvement activities at public hospitals in Thailand.

BACKGROUND: Given the current exceptional burden of injury in Thailand, the proven efficacy of quality improvement programs, and the current scarcity of national-level information on trauma quality improvement program (TQIP) implementation in Thailand, we aimed to examine the use of TQIPs and barriers to TQIP adoption in Thai public trauma centers. METHODS: We distributed a survey to 110 public hospitals which are designated to provide trauma care in Thailand. The survey assessed the presence or absence of the four core elements of the World Health Organization (WHO) recommended TQIPs (morbidity and mortality (M&M) conferences, preventable death panels, trauma registries, and audit filters), and provider perception of barriers and priorities in TQIP implementation. RESULTS: Responses were received from 80 (72%) respondents. Seventy-two (90%) reported having a trauma registry and seventy (88%) respondents reported use of audit filters. Seventy (88%) respondents reported conducting regular M&M conferences, and 45 (56%) respondents reported the presence of preventable death panels. Thirty-eight (48%) respondents reported presence of all four elements of WHO TQIPs. The most commonly reported barriers to implementing TQIPs were lack of interest (55; 68%) and lack of time (39; 48%)to implement TQIPs. Audit filters were reported by only 25 (31%) of respondents and optimization of audit filters was the most frequently identified next-step in further development of TQIP. CONCLUSIONS: Just under half of responding Thai public trauma centers reported implementation of all four elements of the WHO recommended TQIPs. Priority strategies to facilitate TQIP maturation in Thailand should address staff motivation, provision of staff time for TQIP development, and optimization of audit filter use to monitor quality of care.

Antibiotics as part of the management of severe acute malnutrition.

BACKGROUND: Severe acute malnutrition contributes to 1 million deaths among children annually. Adding routine antibiotic agents to nutritional therapy may increase recovery rates and decrease mortality among children with severe acute malnutrition treated in the community. METHODS: In this randomized, double-blind, placebo-controlled trial, we randomly assigned Malawian children, 6 to 59 months of age, with severe acute malnutrition to receive amoxicillin, cefdinir, or placebo for 7 days in addition to ready-to-use therapeutic food for the outpatient treatment of uncomplicated severe acute malnutrition. The primary outcomes were the rate of nutritional recovery and the mortality rate. RESULTS: A total of 2767 children with severe acute malnutrition were enrolled. In the amoxicillin, cefdinir, and placebo groups, 88.7%, 90.9%, and 85.1% of the children recovered, respectively (relative risk of treatment failure with placebo vs. amoxicillin, 1.32; 95% confidence interval [CI], 1.04 to 1.68; relative risk with placebo vs. cefdinir, 1.64; 95% CI, 1.27 to 2.11). The mortality rates for the three groups were 4.8%, 4.1%, and 7.4%, respectively (relative risk of death with placebo vs. amoxicillin, 1.55; 95% CI, 1.07 to 2.24; relative risk with placebo vs. cefdinir, 1.80; 95% CI, 1.22 to 2.64). Among children who recovered, the rate of weight gain was increased among those who received antibiotics. No interaction between type of severe acute malnutrition and intervention group was observed for either the rate of nutritional recovery or the mortality rate. CONCLUSIONS: The addition of antibiotics to therapeutic regimens for uncomplicated severe acute malnutrition was associated with a significant improvement in recovery and mortality rates. (Funded by the Hickey Family Foundation and others; ClinicalTrials.gov number, NCT01000298.).

Investigation of food acceptability and feeding practices for lipid nutrient supplements and blended flours used to treat moderate malnutrition.

OBJECTIVE: To examine acceptability and feeding practices associated with different supplementary food items and identify practices associated with weight gain. METHODS: Caregivers (n = 409) whose children had been enrolled in a trial comparing a fortified corn-soy blended flour (CSB++), soy ready-to-use supplementary food (RUSF), and soy/whey RUSF answered a questionnaire administered by health workers in their homes. RESULTS: No significant differences in acceptability of food types were found. CSB++ was more likely than soy RUSF or soy/whey RUSF to be shared (21% vs 3% vs 8%, respectively, P < .001). Children who received soy/whey RUSF were more likely to feed themselves than children who received soy RUSF or CSB++ (11% vs 4% vs 3%, respectively, P < .05). Refusing food was associated with slower weight gain. CONCLUSIONS AND IMPLICATIONS: Despite similar acceptability, feeding practices differed among food types. Increased nonstaple food consumption is associated with weight gain.

A review of training opportunities for ultrasonography in low and middle income countries.

OBJECTIVE: To review the current training opportunities for ultrasound use for health workers practising in low- and middle-income countries (LMICs). METHODS: A PubMed search using terms ultrasound, sonography, echocardiography, developing country/countries, developing world, low resource settings, low income country/countries, training and education was conducted. Articles from 2000 to 2011 that included data on ultrasonography training were eligible for inclusion. RESULTS: This review shows that most ultrasound scans are performed by generalist and obstetric physicians and even non-medical personnel with little to no formal training in ultrasonography. The spectrum of ultrasonography training described spanned from no formal training to formal certification and residency programmes. All courses included some component of didactics and hands-on training. Follow-up of trainee skills ranged from none, to telemedicine case review, to formal re-evaluations and intensive refresher courses. Ultrasonographic training in LMICs often does not meet the WHO criteria such as the number of scans under supervision and length of training programme recommended by WHO. Nevertheless, some programmes manage to have excellent outcomes with regard to diagnostic accuracy and retention of knowledge by trained personnel. CONCLUSION: Regulation and quality control of training in ultrasound skills for those working in LMICs can be improved. Research on effective training and follow-up should be encouraged.

A novel fortified blended flour, corn-soy blend "plus-plus," is not inferior to lipid-based ready-to-use supplementary foods for the treatment of moderate acute malnutrition in Malawian children.

BACKGROUND: Children with moderate acute malnutrition (MAM) are often treated with fortified blended flours, most commonly a corn-soy blend (CSB). However, recovery rates remain <75%, lower than the rate achieved with peanut paste-based ready-to-use supplementary foods (RUSFs). To bridge this gap, a novel CSB recipe fortified with oil and dry skim milk, "CSB++," has been developed. OBJECTIVE: In this trial we compared CSB++ with 2 RUSF products for the treatment of MAM to test the hypothesis that the recovery rate achieved with CSB++ will not be >5% worse than that achieved with either RUSF. DESIGN: We conducted a prospective, randomized, investigator-blinded, controlled noninferiority trial involving rural Malawian children aged 6-59 mo with MAM. Children received 75 kcal CSB++ · kg(-1) · d(-1), locally produced soy RUSF, or an imported soy/whey RUSF for ≤12 wk. RESULTS: The recovery rate for CSB++ (n = 763 of 888; 85.9%) was similar to that for soy RUSF (795 of 806, 87.7%; risk difference: -1.82%; 95% CI: -4.95%, 1.30%) and soy/whey RUSF (807 of 918, 87.9%; risk difference: -1.99%; 95% CI: -5.10%, 1.13%). On average, children who received CSB++ required 2 d longer to recover, and the rate of weight gain was less than that with either RUSF, although height gain was the same among all 3 foods studied. CONCLUSIONS: A novel, locally produced, fortified blended flour (CSB++) was not inferior to a locally produced soy RUSF and an imported soy/whey RUSF in facilitating recovery from MAM. The recovery rate observed for CSB++ was higher than that for any other fortified blended flour tested previously. This trial is registered at clinicaltrials.gov as NCT00998517.