Report on Mortality from Gluteal Fat Grafting: Recommendations from the ASERF Task Force.

Background: Gluteal fat grafting is among the fastest growing aesthetic procedures in the United States and around the world. Given numerous anecdotal and published reports of fatal and nonfatal pulmonary fat embolism resulting from this procedure, the Aesthetic Surgery Education and Research Foundation (ASERF) formed a Task Force to study this complication. Objectives: To determine the incidence of fatal and nonfatal pulmonary fat embolism associated with gluteal fat grafting and provide recommendations to decrease the risks of the procedure. Methods: An anonymous web-based survey was sent to 4843 plastic surgeons worldwide. Additional data on morbidity and mortality was collected through confidential interviews with plastic surgeons and medical examiners, public records requests for autopsy reports in the United States, and through the American Association for the Accreditation of Ambulatory Surgical Facilities (AAAASF). Results: Six hundred and ninety-two (692) surgeons responding to the survey reported 198,857 cases of gluteal fat grafting. Over their careers, surgeons reported 32 fatalities from pulmonary fat emboli as well as 103 nonfatal pulmonary fat emboli. Three percent (3%) of respondents experienced a patient fatality and 7% of respondents reported at least one pulmonary fat embolism in a patient over their careers. Surgeons reporting the practice of injecting into the deep muscle experienced a significantly increased incidence rate of fatal and nonfatal pulmonary fat emboli. Twenty-five fatalities were confirmed in the United States over the last 5 years through of autopsy reports and interviews with surgeons and medical examiners. Four deaths were reported from 2014 to 2015 from pulmonary fat emboli in AAAASF facilities. Conclusions: Despite the growing popularity of gluteal fat grafting, significantly higher mortality rates appear to be associated with gluteal fat grafting than with any other aesthetic surgical procedure. Based on this survey, fat injections into the deep muscle, using cannulae smaller than 4 mm, and pointing the injection cannula downwards should be avoided. More research is necessary to increase the safety of this procedure.

Friday and weekend hospital stays: effects on mortality.

While weekend hospital admissions are associated with higher mortality, the effects of weekend hospital stays are not known. We assessed whether patients hospitalised for chronic obstructive pulmonary disease (COPD) or pneumonia have higher mortality during weekend and Friday stays. Our cohort consisted of all hospitalisations for COPD or pneumonia during 1990-2007 from the healthcare databases of the province of Quebec, Canada. The hazard ratio (HR) of in-patient death associated with Friday and weekend stay was estimated by the Cox model with time-dependent covariates, adjusted for age, sex and comorbidity. The cohort included 323 895 hospitalisations for COPD or pneumonia during which 32 414 deaths occurred (rate of death 8.06 per 1000 per day). Mortality was higher for weekend (HR 1.06, 95% CI 1.03-1.09) but not Friday admissions (HR 0.97, 95% CI 0.95-1.00), relative to Monday-Thursday admissions. Independently of the admission day, mortality was higher during weekend stays (HR 1.07, 95% CI 1.04-1.09) and Friday stays (HR 1.05, 95% CI 1.02-1.08), relative to Monday-Thursday stays. Patients hospitalised for COPD or pneumonia are at increased risk of death when staying over on a Friday or a weekend. The additional 40-56 deaths per 100 000 patients staying in hospital on those days are most likely due to reduced access to healthcare at that time.

Non-steroidal anti-inflammatory drugs and the risk of Clostridium difficile-associated disease.

AIM: Several case reports have linked diclofenac, a non-steroidal anti-inflammatory drug (NSAID), with Clostridium difficile associated disease (CDAD). We assessed whether NSAID use in general, and diclofenac use in particular, is associated with an increased risk of CDAD. METHODS: We used the United Kingdom's General Practice Research Database (GPRD) to conduct a population-based case-control study. All cases of CDAD occurring between 1994 and 2005 were identified and were matched to 10 controls each. Conditional logistic regression was used to estimate the odds ratio of CDAD associated with current NSAID use, adjusting for covariates. RESULTS: We identified 1360 CDAD cases and 13 072 controls. We found an increased risk of CDAD associated with diclofenac (adjusted odds ratio (RR) 1.35, 95% confidence interval (CI) 1.10, 1.67). We did not observe an increased risk of CDAD with use of any other NSAID. No dose-response for diclofenac exposure was found. When we analyzed only patients who were not hospitalized in the year before the index date, we found diclofenac to have a similar effect on CDAD risk (adjusted RR 1.43, 95% CI 1.11, 1.84). CONCLUSION: Diclofenac use is associated with a modest increase in the risk of CDAD. In patients at risk of CDAD, other NSAIDs could be prescribed.

Number needed to treat is incorrect without proper time-related considerations.

The number needed to treat (NNT) is a simple measure of a treatment's impact, increasingly reported in randomized trials and observational studies. Its calculation in studies involving varying follow-up times or recurrent outcomes has been criticized. We discuss the NNT in these contexts, illustrating using several published studies. The computation of the NNT is founded on the cumulative incidence of the outcome. Instead, several published studies use simple proportions that do not account for varying follow-up times, or use incidence rates per person-time. We show that these approaches can lead to erroneous values of the NNT and misleading interpretations. For example, after converting the incidence rate to a cumulative incidence, we show that a trial reporting a NNT of 4 "to prevent one exacerbation in 1 year" should have reported a NNT of 9. A survey of all papers reporting NNT, published in four major medical journals in 2009, found that 6 out of all 10 papers involving varying follow-up times did not correctly estimate the NNT. As the "number needed to treat" becomes increasingly used in complex studies and in the comparative effectiveness of therapies, its accurate estimation and interpretation become crucial to avoid erroneous clinical and public health decisions.

Negative-pressure therapy versus standard wound care: a meta-analysis of randomized trials.

BACKGROUND: Several randomized controlled trials comparing negative-pressure therapy to standard wound care for chronic wounds have been published. Although these studies suggest a benefit for negative-pressure therapy, the majority of the review articles on the topic conclude that the studies are inconclusive. The authors conducted a quantitative meta-analysis of the effectiveness of negative-pressure therapy for the management of chronic wounds. METHODS: The MEDLINE, EMBASE, and Cochrane databases were searched from 1993 to March of 2010 for randomized controlled trials comparing negative-pressure therapy to standard wound care for chronic wounds. Measures of wound size and time to healing, along with the corresponding p values, were extracted from the randomized controlled trials. Relative change ratios of wound size and ratios of median time to healing were combined using a random effects model for meta-analysis. RESULTS: Ten trials of negative-pressure therapy versus standard wound care were found. In the negative-pressure therapy group, wound size had decreased significantly more than in the standard wound care group (relative change ratio, 0.77; 95 percent confidence interval, 0.63 to 0.96). Time to healing was significantly shorter in the negative-pressure therapy group in comparison with the standard wound care group (ratio of median time to healing, 0.74; 95 percent confidence interval, 0.70 to 0.78). CONCLUSIONS: This quantitative meta-analysis of randomized trials suggests that negative-pressure therapy appears to be an effective treatment for chronic wounds. An effect of publication bias cannot be ruled out. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.