Background: Real-world evidence (RWE) is increasingly used to inform health technology assessments for resource allocation, which are valuable tools for emerging economies such as in America. Nevertheless, the characteristics and uses in South America are unknown.Objectives: To identify sources, characteristics, and uses of RWE in Argentina, Brazil, Colombia, and Chile, and evaluate the context-specific challenges. The implications for future regulation and responsible management of RWE in the region are also considered.Methods: A systematic literature review, database mapping, and targeted gray literature search were conducted to identify the sources and characteristics of RWE. Findings were validated by key opinion leaders attending workshops in 4 South American countries.Results: A database mapping exercise revealed 407 unique databases. Geographic scope, database type, population, and outcomes captured were reported. Characteristics of national health information systems show efforts to collect interoperable data from service providers, insurers, and government agencies, but that initiatives are hampered by fragmentation, lack of stewardship, and resources. In South America, RWE is mainly used for pharmacovigilance and as pure academic research, but less so for health technology assessment decision making or pricing negotiations and not at all to inform early access schemes.Conclusions: The quality of real-world data in the case study countries vary and RWE is not consistently used in healthcare decision making. Authors recommend that future studies monitor the impact of digitalization and the potential effects of access to RWE on the quality of patient care.

No abstract

Population health surveys are rarely comprehensive in addressing sexual health, and population-representative surveys often lack standardised measures for collecting comparable data across countries. We present a sexual health survey instrument and implementation considerations for population-level sexual health research. The brief, comprehensive sexual health survey and consensus statement was developed via a multi-step process (an open call, a hackathon, and a modified Delphi process). The survey items, domains, entire instruments, and implementation considerations to develop a sexual health survey were solicited via a global crowdsourcing open call. The open call received 175 contributions from 49 countries. Following review of submissions from the open call, 18 finalists and eight facilitators with expertise in sexual health research, especially in low- and middle-income countries (LMICs), were invited to a 3-day hackathon to harmonise a survey instrument. Consensus was achieved through an iterative, modified Delphi process that included three rounds of online surveys. The entire process resulted in a 19-item consensus statement and a brief sexual health survey instrument. This is the first global consensus on a sexual and reproductive health survey instrument that can be used to generate cross-national comparative data in both high-income and LMICs. The inclusive process identified priority domains for improvement and can inform the design of sexual and reproductive health programs and contextually relevant data for comparable research across countries.

We compared vestibulo-ocular reflex, optokinetic reflex and postural function in subjects with insulin-dependent diabetes mellitus (IDDM) and non-insulin-dependent diabetes mellitus (NIDDM), as well as non-diabetic controls. Both IDDM and NIDDM subjects exhibited significant deficits in gaze-holding in darkness (p < 0.05), small changes in vestibulo-ocular reflex (VOR) phase re velocity (p < 0.005) without a change in VOR gain, and a decrease in optokinetic reflex (OKR) slow phase velocity (p < 0.001). In addition, a smaller decrease was found in OKR quick phase amplitude (p < 0.02); postural sway was increased in both diabetic groups (p < 0.05), although this was not specific to the conditions of the Clinical Test of Sensory Interaction and Balance (CTSIB) that test vestibular contributions to postural stability. No differences were found in optokinetic afternystagmus or latency to circularvection. These results suggest that both IDDM and NIDDM are associated with deficits in gaze-holding, VOR and OKR function.

ABSTRACT. Objective. Early recognition of invasive meningococcal disease in children may be difficult. Extremity pain and refusal to walk (extremity symptoms) are uncommonly mentioned as clinical findings in children who present with this disease. We sought to determine 1) the frequency of extremity symptoms as part of the clinical presentation in children with invasive meningococcal disease and 2) whether these symptoms help identify children with otherwise unsuspected meningococcal disease.Methods. We reviewed the medical records of patients who were younger than 20 years and had invasive meningococcal disease from 1985 to 1996 at 3 pediatric referral centers. Children with extremity symptoms were identified and described. We compared clinical and laboratory findings and frequency of adverse outcomes between these children and those with invasive meningococcal disease without extremity symptoms.Results. We identified 274 children with invasive meningococcal disease, 45 (16%) of whom had either history or physical examination evidence of extremity pain (31) or refusal to walk (14) as part of their clinical presentations. Five of the 45 patients had arthritis at the time of presentation. Patients with extremity symptoms at presentation were significantly older (77.9 ؎ 62.2 vs 44.0 ؎ 56.9 months), had lower temperatures (38.8 ؎ 1.2°C vs 39.2 ؎ 1.2°C), and had higher band counts (28.2 ؎ 15.2% vs 18.1 ؎ 12.4%) than did patients without extremity symptoms. There were no significant differences, however, between groups with regard to rash, white blood cell counts, coagulation parameters, prevalence of meningitis, or adverse outcomes. Seventy-three (27%) of the 274 patients had unsuspected disease, and 5 (7%) of these had extremity symptoms at the time of diagnosis.Conclusions. Sixteen percent of children with invasive meningococcal disease have extremity symptoms at the time of diagnosis. These symptoms may help to identify some patients with otherwise unsuspected invasive meningococcal disease. Pediatrics 2002;110(1). URL: http://www.pediatrics.org/cgi/content/full/110/1/e3; meningococcal infections, fever, bacteremia, myalgia, limp.ABREVIATIONS. CSF, cerebrospinal fluid; WBC, white blood cell; PT, prothrombin time; PTT, partial thromboplastin time; OR, odds ratio; CI, confidence interval; DIC, disseminated intravascular coagulation.T he clinical manifestations of invasive meningococcal disease in children typically consist of fever with toxic clinical appearance, irritability, lethargy, nuchal rigidity, hypotension, and petechial/purpuric rash. 1-6 Some children with invasive meningococcal disease, however, present in a more subtle manner with fever without clinical toxicity and other nonspecific symptoms, such as cough, rhinorrhea, vomiting, and headache, resembling an upper respiratory tract infection or other viral illness. [5][6][7] Although early recognition and treatment of meningococcal disease decreases complications, 7 neither the physical examination nor the hematologic evaluation reliably enables health ...