Which outcomes are most important to measure in patients with COVID-19 and how and when should these be measured? Development of an international standard set of outcomes measures for clinical use in patients with COVID-19: a report of the International Consortium for Health Outcomes Measurement (ICHOM) COVID-19 Working Group.

OBJECTIVES: The COVID-19 pandemic has resulted in widespread morbidity and mortality with the consequences expected to be felt for many years. Significant variation exists in the care even of similar patients with COVID-19, including treatment practices within and between institutions. Outcome measures vary among clinical trials on the same therapies. Understanding which therapies are of most value is not possible unless consensus can be reached on which outcomes are most important to measure. Furthermore, consensus on the most important outcomes may enable patients to monitor and track their care, and may help providers to improve the care they offer through quality improvement. To develop a standardised minimum set of outcomes for clinical care, the International Consortium for Health Outcomes Measurement (ICHOM) assembled a working group (WG) of 28 volunteers, including health professionals, patients and patient representatives. DESIGN: A list of outcomes important to patients and professionals was generated from a systematic review of the published literature using the MEDLINE database, from review of outcomes being measured in ongoing clinical trials, from a survey distributed to patients and patient networks, and from previously published ICHOM standard sets in other disease areas. Using an online-modified Delphi process, the WG selected outcomes of greatest importance. RESULTS: The outcomes considered by the WG to be most important were selected and categorised into five domains: (1) functional status and quality of life, (2) mental functioning, (3) social functioning, (4) clinical outcomes and (5) symptoms. The WG identified demographic and clinical variables for use as case-mix risk adjusters. These included baseline demographics, clinical factors and treatment-related factors. CONCLUSION: Implementation of these consensus recommendations could help institutions to monitor, compare and improve the quality and delivery of care to patients with COVID-19. Their consistent definition and collection could also broaden the implementation of more patient-centric clinical outcomes research.

Infection of a prosthetic knee joint with Clostridium bifermentans.

We present the first reported case of prosthetic joint infection caused by Clostridium bifermentans, which was treated with total joint washout and debridement allowing for the patient to retain his prosthesis and achieve full recovery. Clostridium bifermentans is a gram-positive, anaerobic, spore-forming bacterium. This organism was once considered to be non-pathogenic, but has recently been associated with cases of septic arthritis, empyema, osteomyelitis, soft tissue infection, brain abscess, bacteremia and endocarditis.

Management of diaphyseal tibial fractures by plate fixation with absolute or relative stability: a retrospective study of 45 patients.

BACKGROUND: Fixation of diaphyseal tibial fractures by plates is not considered the best option due to complications that may eventually arise; however, if principles of stability and proper surgical techniques are used, it is possible to obtain fracture consolidation without major risks. METHODS: We conducted a cross-sectional observational descriptive study by retrospectively analyzing medical records of patients with diaphyseal tibial fractures that were treated with plates from the period between June 2011 and June 2014 at San José and Susana López Hospitals in the city of Popayan, Colombia. 3 treatment groups were created and analyzed according to the type of fracture (Association Osteosynthesis/Osteosynthesis Trauma Association AO/OTA): group I: simple fractures 42A/B, absolute stability; group II: simple fractures 42A/B, Minimally Invasive Plate Osteosynthesis (MIPO) technique, relative stability; group III: multifragmentary fractures 42C, MIPO technique, relative stability. A descriptive analysis of patients, fracture consolidation time, and complications in each group were performed. RESULTS: 45 patients with tibial fractures treated with osteosynthesis plates were analyzed. Group I: 14 patients, 42A (n=13) and 42B (n=1), had an average consolidation time of 16.38 (SD=1.98) and 14 weeks, respectively. In group II: 19 patients, out of which 18 achieved fracture consolidation (42A n=15 and 42B n=3) with an average time of 17.4 (SD=3.33) and 17.3 weeks (SD=6.11), respectively. Finally, in group III: 12 patients all with 42C fractures with a consolidation time of 16.86 (SD=2.93) weeks. The average fracture consolidation time for all 44 patients was 16.86 weeks (SD 2.93). CONCLUSIONS: Osteosynthesis plates are an alternative to intramedullary nailing for diaphyseal tibial fractures and their outcomes can be favorable as long as the management of soft tissues and the proper principle of stability are taken into account. LEVEL OF EVIDENCE: IV.

Clinical Impact of Vaccine Development.

The discovery and development of immunization has been a singular improvement in the health of mankind. This chapter reviews currently available vaccines, their historical development, and impact on public health. Specific mention is made in regard to the challenges and pursuit of a vaccine for the human immunodeficiency virus as well as the unfounded link between autism and measles vaccination.

Seco-limonoid derived from Raputia heptaphylla promotes the control of cutaneous leishmaniasis in hamsters (Mesocricetus auratus).

The rational search of novel bioactive molecules against pathogens with immunomodulatory activity is presently one of the most significant approaches to discover and design new therapeutic agents for effective control of infectious diseases, such as the infection caused by Leishmania parasites. In the present study, we evaluated the therapeutic efficacy of the recently characterized immunomodulatory compound 11α,19ß-dihydroxy-7-acetoxy-7-deoxoichangin, a seco-limonoid derived from the bark of Raputia heptaphylla (Pittier) using: (1) peritoneal macrophages and (2) Mesocricetus auratus hamsters infected with Leishmania (V.) panamensis and Leishmania (L.) amazonensis. We observed the ability of this seco-limonoid to induce the effective control of the parasite either in vitro [determining an effective concentration 50 (EC50) of 59 µ m at the infection model] and in vivo (inducing clinical improvement or even cure in infected animals treated compared with the groups of animals treated with vehicle solution or meglumine antimoniate).

Development of a novel formulation with hypericin to treat cutaneous leishmaniasis based on photodynamic therapy in in vitro and in vivo studies.

An evaluation of the leishmanicidal activity in vitro and in vivo of hypericin, an expanded-spectrum photosensitizer found in Hypericum perforatum, is presented. Hypericin was evaluated against intracellular amastigotes in vitro of Leishmania (Viannia) panamensis. A topical formulation containing 0.5% hypericin was developed and assayed in vivo in a hamster model of cutaneous leishmaniasis. Results demonstrate that hypericin induces a significant antiamastigote effect in vitro against L. panamensis by decreasing the number of parasites inside infected cells. The topical formulation of 0.5% hypericin allows healing of L. panamensis-induced lesions upon a topical application of 40 mg/day plus visible-light irradiation (5 J/cm(2), 15 min), twice a week for 3 weeks.

Cutaneous leishmaniasis in the dorsal skin of hamsters: a useful model for the screening of antileishmanial drugs.

Traditionally, hamsters are experimentally inoculated in the snout or the footpad. However in these sites an ulcer not always occurs, measurement of lesion size is a hard procedure and animals show difficulty to eat, breathe and move because of the lesion. In order to optimize the hamster model for cutaneous leishmaniasis, young adult male and female golden hamsters (Mesocricetus auratus) were injected intradermally at the dorsal skin with 1 to 1.5 x l0(7) promastigotes of Leishmania species and progression of subsequent lesions were evaluated for up to 16 weeks post infection. The golden hamster was selected because it is considered the adequate bio-model to evaluate drugs against Leishmania as they are susceptible to infection by different species. Cutaneous infection of hamsters results in chronic but controlled lesions, and a clinical evolution with signs similar to those observed in humans. Therefore, the establishment of the extent of infection by measuring the size of the lesion according to the area of indurations and ulcers is feasible. This approach has proven its versatility and easy management during inoculation, follow up and characterization of typical lesions (ulcers), application of treatments through different ways and obtaining of clinical samples after different treatments. By using this method the quality of animal life regarding locomotion, search for food and water, play and social activities is also preserved.

Profundización de copas acetabulares no cementadas en reemplazo total de cadera en pacientes con displasia acetabular. Experiencia Hospital Universitario Clínica San Rafael / Deepening of uncemented acetabular cups in total hip replacement in patients with acetabular dysplasia. Experience Clinic University Hospital San Rafael

14 pacientes con displasia acetabular fueron tratados en el Hospital Universitario Clínica San Rafael con profundización de copas no cementadas, en reemplazos totales de cadera. De acuerdo a la clasificación de Crowe, una fue tipo 1, ocho fueron tipo 2, cinco fueron tipo 3. El seguimiento promedio fue de catorce meses. Se evaluaron clínicamente con la escala de Harris; el promedio preoperatorio fue de 35 puntos y postoperatorio de 87 puntos. La cantidad de profundización promedio de la copa fue de cuatro milímetros, con un protrusio promedio de 47% y cobertura promedio de 81%. El centro de la cabeza femoral se profundizó en promedio 26 mm. Se utilizaron tornillos para fijación de la copa en 3 pacientes. No se presentaron complicaciones, ni se han hecho necesarias revisiones hasta el momento del corte del seguimiento.