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OBJECTIVE: To explore whether placebo surgery controlled trials achieve what they set out to do by investigating discrepancy between projected and actual design aspects of trials identified through systematic review methods. SUMMARY BACKGROUND: Interest in placebo surgery controlled trials is growing in response to concerns regarding unnecessary surgery and the societal cost of low-value healthcare. As questions about the justifiability of using placebo controls in surgery have been addressed, attention is now being paid to more practical concerns. METHODS: Six databases were searched from inception - May 2020 (MEDLINE, Embase, Emcare, APA PsycInfo, CINAHL, Cochrane Library). Placebo surgery controlled trials with a published protocol were included. Three authors extracted "projected" design aspects from protocols and "actual" design aspects from main findings papers. Absolute and relative difference between projected and actual design aspects were presented for each trial. Trials were grouped according to whether they met their target sample size ("completed") and were concluded in a timely fashion. Pairs of authors assessed risk of bias. RESULTS: Of 24 trials with data available to analyse; 3 were completed and concluded within target timeframe; 10 were completed and concluded outside the target timeline; 4 were completed without clear target timeframes; 2 were incomplete and concluded within the target framework; 5 were incomplete and concluded outside the target timeline. Trials which reached the recruitment target underestimated trial duration by 88% and number of recruitment sites by 87%. CONCLUSIONS: Trialists need to factor additional time and sites into future placebo surgery controlled trials. A robust reporting framework of projected and actual trial design is imperative for trialists to learn from their predecessors. REVIEW REGISTRATION: PROSPERO (CRD42019133296).
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Ensayos Clínicos Controlados como Asunto/métodos , Placebos , Procedimientos Quirúrgicos Operativos , HumanosRESUMEN
BACKGROUND: The disruption to the immune system and profound metabolic response to burn injury gives rise to a unique susceptibility to infection. Indeed, infection is one of the most frequently encountered post-burns complications placing significant burden on patients and healthcare system. Advancements in burn care have led to marked improvements in burn-related mortality and morbidity; however, scarce hospital resources hamper adequate burn-related care, and patient length of stay (LOS) in hospital is an important drain on such resources. The aim of this review was to assess and evaluate the existing literature relating to the impact of infections on LOS in hospitalised, adult burn patients. METHODS: Electronic searches were performed in Medline and Embase. Eligible studies were those reporting on LOS and infection in adult burn populations. Articles published before 2000 were excluded to ensure that the analysis was focused on contemporary literature that reflects current, clinical management of burn patients. RESULTS: Nineteen studies (54,397 burn patients) were included in the review. All studies were retrospective, with the majority undertaken in North America (14 studies). The mean age range was 38-67 years and the majority of patients were male. Inhalation injury was recorded in eleven studies. The most common types of infection included pneumonia, blood stream infections (BSI) and burn wound infections. Overall, there was a trend towards a positive association between infection and LOS. CONCLUSION: The results of this scoping review provide an overview of the existing literature on the relationship between infection and LOS in adult burn populations. However, significant gaps remain in knowledge which call for further high-quality research. Standardised definitions for the collection of infection data and the use of burns specific infection control guidelines are also critical to understanding and improving patient outcomes.
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Quemaduras , Tiempo de Internación , Infección de Heridas , Humanos , Quemaduras/terapia , Quemaduras/complicaciones , Tiempo de Internación/estadística & datos numéricos , Infección de Heridas/epidemiología , Neumonía/epidemiología , Bacteriemia/epidemiología , Quemaduras por Inhalación/terapia , Adulto , Lesión por Inhalación de Humo/terapiaRESUMEN
BACKGROUND: Chest wall sarcomas are a rare group of tumours. Surgical resection is considered the mainstay of curative treatment, however, resection and reconstruction of chest wall defects presents complex issues for the clinician. METHODS: A retrospective analysis of 59 patients undergoing surgical management of chest wall sarcoma between December 1996 and July 2020 was conducted across a multidisciplinary sarcoma service in Melbourne, Australia. Patient demographics, pathologic data, and long-term outcomes were recorded. RESULTS: Mean age at surgery was 48.4 years (SD 18.3), and 66.1% were male. Median follow-up was 29 months (IQR 11.8, 51.0 months). Fifty-one patients presented with primary tumours, while the others had secondary tumours resected. Most tumours arose in bone (72.9%) as opposed to soft tissues (27.1%). Chondrosarcoma was the most common histologic subtype (50.8%). The most common reconstructive techniques involved the use of mesh (79.7%) or mesh supplemented with bone cement (33.9%). Overall survival at 1 and 5 years was 92% and 70%, respectively. Seven patients died of metastatic sarcoma during the follow up period with a median survival time of 27 months. Twelve patients had evidence of disease recurrence during the follow-up period. Stage 4 disease, soft tissue tumours, secondary tumours, leiomyosarcoma and UPS subtypes, and plating reconstruction were associated with increased disease recurrence. CONCLUSIONS: The results suggest that outcomes for chest wall sarcoma are similar to extremity sarcomas and may be treated in a similar manner. Patients requiring adjuvant radiotherapy and those who develop disease-recurrence are more likely to have worse overall survival outcome despite complete surgical resection.
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Neoplasias Óseas , Procedimientos de Cirugía Plástica , Sarcoma , Neoplasias de los Tejidos Blandos , Neoplasias Torácicas , Pared Torácica , Australia/epidemiología , Cementos para Huesos , Neoplasias Óseas/patología , Neoplasias Óseas/cirugía , Femenino , Humanos , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/patología , Procedimientos de Cirugía Plástica/métodos , Estudios Retrospectivos , Sarcoma/patología , Neoplasias de los Tejidos Blandos/patología , Neoplasias de los Tejidos Blandos/cirugía , Neoplasias Torácicas/patología , Neoplasias Torácicas/cirugía , Pared Torácica/patología , Pared Torácica/cirugíaRESUMEN
BACKGROUND: The influence of sex on the failure of débridement antibiotics and implant retention (DAIR) for treating prosthetic joint infection (PJI) is important for decision-making, patient counseling, and equitable health care. However, very few studies in the orthopaedic literature conduct sex-specific analyses. AIM: The primary aim was to determine whether sex influences treatment success after DAIR. METHODS: A systematic review and individual patient data (IPD) meta-analysis was conducted. MEDLINE (Ovid), EMBASE (Ovid), Web of Science, and Google Scholar were searched, and IPD was requested via e-mail. Patients who underwent DAIR after developing PJI within 12 months of a primary total hip or knee arthroplasty were included in the analysis. Treatment failure was defined by the Delphi International Consensus criteria. Adjusted odds ratios for treatment failure were calculated using a mixed-effects logistic regression. RESULTS: The study collected and analyzed IPD of 1,116 patients from 21 cohorts. The odds of treatment failure were 29% lower in women (odds ratio, 0.71; 95% CI 0.54 to 0.017; P = 0.017), after adjusting for duration of symptoms >7 days and Staphylococcus aureus infection (methicillin-susceptible Staphylococcus aureus or any infection with S aureus). None of the 64 studies included in the systematic review conducted a sex-specific analysis. CONCLUSION: For patients who developed a PJI within 1 year postsurgery, females have lower odds of DAIR failure than males. Other factors also have varying effects on outcome for men and women. It is essential to implement sex-specific analysis in orthopaedic research.