Procalcitonin-guided therapy in intensive care unit patients with severe sepsis and septic shock – a systematic review and meta-analysis

INTRODUCTION: Procalcitonin (PCT) algorithms for antibiotic treatment decisions have been studied in adult patients from primary care, emergency department, and intensive care unit (ICU) settings, suggesting that procalcitonin-guided therapy may reduce antibiotic exposure without increasing the mortality rate. However, information on the efficacy and safety of this approach in the most vulnerable population of critically ill patients with severe sepsis and septic shock is missing. METHOD: Two reviewers independently performed a systematic search in PubMed, Embase, ISI Web of Knowledge, BioMed Central, ScienceDirect, Cochrane Central Register of Controlled Trials, http://www.ClinicalTrials.gov and http://www.ISRCTN.org. Eligible studies had to be randomized controlled clinical trials or cohort studies which compare procalcitonin-guided therapy with standard care in severe sepsis patients and report at least one of the following outcomes: hospital mortality, 28-day mortality, duration of antimicrobial therapy, length of stay in the intensive care unit or length of hospital stay. Disagreements about inclusion of studies and judgment of bias were solved by consensus. RESULTS: Finally seven studies comprising a total of 1,075 patients with severe sepsis or septic shock were included in the meta-analysis. Both hospital mortality (RR [relative risk]: 0.91, 95%CI [confidence interval]: 0.61; 1.36) and 28-day mortality (RR: 1.02, 95%CI: 0.85; 1.23) were not different between procalcitonin-guided therapy and standard treatment groups. Duration of antimicrobial therapy was significantly reduced in favor of procalcitonin-guided therapy (HR [hazard ratio]: 1.27, 95%CI: 1.01; 1.53). Combined estimates of the length of stay in the ICU and in hospital did not differ between groups. CONCLUSION: Procalcitonin-guided therapy is a helpful approach to guide antibiotic therapy and surgical interventions without a beneficial effect on mortality. The major benefit of PCT-guided therapy consists of a shorter duration of antibiotic treatment compared to standard care. Trials are needed to investigate the effect of PCT-guided therapy on mortality, length of ICU and in-hospital stay in severe sepsis patients

Trends in treatment of head and neck cancer in germany: A diagnosis-related-groups-based nationwide analysis, 2005–2018

Simple Summary Surgery, radiotherapy, and chemotherapy/immunotherapy as monotherapy or in combination are the pillars of the treatment of head and neck cancer (HNC). Nation-wide population-based data on treatment rates per population and year for HNC are sparse. The data of virtually all HNC cases (apart from thyroid cancer) treated as inpatients in Germany between 2005 and 2018 were analyzed. Treatment rates for nearly all treatment types increased for cancer of the oral cavity, oropharynx, and salivary glands. Treatment rates for nasopharyngeal cancer in both sexes and hypopharyngeal cancer in men mainly decreased. In women, surgery for hypopharyngeal cancer decreased, but radiotherapy, chemotherapy, or in combination, increased. Laryngeal cancer showed a mixed picture: Surgery and neck dissection decreased in men and remained unchanged in women, whereas radiotherapy, chemotherapy, or in combination, remained unchanged in men, but increased in women. Changes in treatment are dependent on the subsites and are different for men and women for several subsites. Abstract Advances in head and neck cancer (HNC) treatment might have changed treatment strategies. This study determined, with focus on gender disparity, whether treatment rates have changed for inpatients in Germany between 2005 and 2018. Nation-wide population-based diagnosis-related groups (DRG) data of virtually all HNC cases (1,226,856 procedures; 78% men) were evaluated. Poisson regression analyses were used to study changes of annual treatment rates per German population. For surgery, the highest increase was seen for women with cancer of the oral cavity (relative risk (RR) 1.14, 95% confidence interval (CI) 1.11–1.18, p < 0.0001) and the highest decrease for men with laryngeal cancer (RR 0.90, CI 0.87–0.93). In women with oropharyngeal cancer, the highest increase of radiotherapy rates was seen (RR 1.18, CI 1.10–1.27, p < 0.0001). A decrease was seen in men for hypopharyngeal cancer (RR 0.93, CI 0.87–0.98, p = 0.0093). The highest increase for chemotherapy/immunotherapy was seen for women with oropharyngeal cancer (RR 1.16, CI 1.08–1.24, p < 0.0001), and a decrease in men with hypopharyngeal cancer (RR 0.93, CI 0.88–0.97, p = 0.0014). Treatment patterns had changed for nearly all subsites and therapy types. There were relevant gender disparities, which cannot be explained by the DRG data

Nutrient Intake and Nutrition Status in Vegetarians and Vegans in Comparison to Omnivores - the Nutritional Evaluation (NuEva) Study

IntroductionIn recent years, vegetarian and vegan diets became increasingly important as they are associated with beneficial health outcomes. Therefore, the NuEva study compares the impact of flexitarian, vegetarian, or vegan diets with omnivorous nutritional habits on nutrient intake and risk factors for non-communicable diseases.MethodsA dietary protocol was kept over five days and blood and 24h urine samples were collected to examine the impact of dietary habits [omnivores, n = 65 (Median/Interquartile range: 33/17 yrs.), flexitarians, n = 70 (30/17 yrs.), ovo-lacto vegetarians, n = 65 (28/14 yrs.), vegans, n = 58 (25/10 yrs.)] on nutrient intake, nutrient concentrations in plasma, serum or 24h urine, body composition, and blood lipids.ResultsThe increased exclusion of animal based foods in the diet (omnivores &lt; flexitarians &lt; vegetarians &lt; vegans) is associated with a decreased intake of energy, saturated fat, cholesterol, disaccharides, and total sugar as well an increased intake of dietary fibers, beta carotene, vitamin E and K. The combined index of the B12 status (4cB12 score) in vegetarians (0.02/0.75) was lower compared to omnivores (0.34/0.58; p ≤ 0.05) and flexitarians (0.24/0.52; p ≤ 0.05). In omnivores vitamin A, vitamin E, ferritin, and the urinary excretion of selenium, iodine, and zinc were higher than in vegans (p ≤ 0.05). In contrast, vegans had the highest concentrations of biotin, folate, and vitamin C. Flexitarians, vegetarians, and vegans had a lower body weight, BMI, and body fat percentage in comparison to omnivores (p ≤ 0.05). In omnivores the concentrations on total cholesterol, total cholesterol/HDL cholesterol ratio, LDL cholesterol, LDL cholesterol/HDL cholesterol ratio, apolipoprotein B, and apolipoprotein B/ apolipoprotein A1 ratio were higher than in vegetarians and vegans (p ≤ 0.05).ConclusionThe NuEva study confirms the position of the Academy of Nutrition and Dietetics that adequately planned vegetarian diets are healthy, nutritionally adequate, and may provide health benefits in the prevention and treatment of non-communicable diseases. Nevertheless, critical nutrients were identified for all groups studied. This highlights the need to develop individual nutritional concepts to ensure an adequate nutrient intake

Surgery for bilateral vocal fold paralysis: Systematic review and meta-analysis

ObjectivesTo determine the decannulation rate (DR) and revision surgery rate after surgery for bilateral vocal fold paralysis (BVFP).Data SourcesFive databases (MEDLINE, PubMed, Embase, Web of Science, Scopus) were searched for the period 1908–2020.MethodsThe systematic literature review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data were pooled using a random-mixed-effects model. Randomized controlled trials and non-randomized studies (case-control, cohort, and case series) were included to assess DR and revision surgery rate after different surgical techniques for treatment of BVFP.ResultsThe search yielded 857 publications, of which 102 with 2802 patients were included. DR after different types of surgery was: arytenoid abduction (DR 0.93, 95%-confidence interval [CI], 0.86–0.97), endolaryngeal arytenoidectomy (DR 0.92, 95%-CI, 0.86–0.96), external arytenoidectomy (DR 0.94; 95%-CI, 0.71–0.99), external arytenoidectomy and lateralisation (DR 0.87; 95%-CI, 0.73–0.94), laterofixation (DR 0.95; 95%-CI, 0.91–0.97), posterior cordectomy (DR 0.97, 95%-CI, 0.94–0.99), posterior cordectomy and arytenoidectomy (DR 0.98, 95%-CI, 0.93–0.99), posterior cordectomy and subtotal arytenoidectomy (DR 0.98, 95%-CI, 0.88–1.00), posterior cordotomy (DR 0.96, 95%-CI, 0.84–0.99), reinnervation (0.69, 95%-CI, 0.12–0.97), subtotal arytenoidectomy (DR 1.00, 95%-CI, 0.00–1.00) and transverse cordotomy (DR 1.0, 95%-CI, 0.00–1.00). No significant difference between subgroups for DR could be found (Q = 15.67, df = 11, p = 0.1540). The between-study heterogeneity was low (τ2 = 2.2627; τ = 1.5042; I2 = 0.0%). Studies were at high risk of bias.ConclusionBLVP is a rare disease and the study quality is insufficient. The existing studies suggest a publication bias and the literature review revealed that there is a lack of prospective controlled studies. There is a lack of standardized measures that takes into account both speech quality and respiratory function and allows adequate comparison of surgical methods

Nutrient intake and nutrition status in vegetarians and vegans in comparison to omnivores - the nutritional evaluation (NuEva) study

In recent years, vegetarian and vegan diets became increasingly important as they are associated with beneficial health outcomes. Therefore, the NuEva study compares the impact of flexitarian, vegetarian, or vegan diets with omnivorous nutritional habits on nutrient intake and risk factors for non-communicable diseases. Methods A dietary protocol was kept over five days and blood and 24h urine samples were collected to examine the impact of dietary habits [omnivores, n = 65 (Median/Interquartile range: 33/17 yrs.), flexitarians, n = 70 (30/17 yrs.), ovo-lacto vegetarians, n = 65 (28/14 yrs.), vegans, n = 58 (25/10 yrs.)] on nutrient intake, nutrient concentrations in plasma, serum or 24h urine, body composition, and blood lipids. Results The increased exclusion of animal based foods in the diet (omnivores < flexitarians < vegetarians < vegans) is associated with a decreased intake of energy, saturated fat, cholesterol, disaccharides, and total sugar as well an increased intake of dietary fibers, beta carotene, vitamin E and K. The combined index of the B12 status (4cB12 score) in vegetarians (0.02/0.75) was lower compared to omnivores (0.34/0.58; p ≤ 0.05) and flexitarians (0.24/0.52; p ≤ 0.05). In omnivores vitamin A, vitamin E, ferritin, and the urinary excretion of selenium, iodine, and zinc were higher than in vegans ( p ≤ 0.05). In contrast, vegans had the highest concentrations of biotin, folate, and vitamin C. Flexitarians, vegetarians, and vegans had a lower body weight, BMI, and body fat percentage in comparison to omnivores ( p ≤ 0.05). In omnivores the concentrations on total cholesterol, total cholesterol/HDL cholesterol ratio, LDL cholesterol, LDL cholesterol/HDL cholesterol ratio, apolipoprotein B, and apolipoprotein B/ apolipoprotein A1 ratio were higher than in vegetarians and vegans ( p ≤ 0.05). Conclusion The NuEva study confirms the position of the Academy of Nutrition and Dietetics that adequately planned vegetarian diets are healthy, nutritionally adequate, and may provide health benefits in the prevention and treatment of non-communicable diseases. Nevertheless, critical nutrients were identified for all groups studied. This highlights the need to develop individual nutritional concepts to ensure an adequate nutrient intake

Systematic survey of the design, statistical analysis, and reporting of studies published in the 2008 volume of the Journal of Cerebral Blood Flow and Metabolism

Translating experimental findings into clinically effective therapies is one of the major bottlenecks of modern medicine. As this has been particularly true for cerebrovascular research, attention has turned to the quality and validity of experimental cerebrovascular studies. We set out to assess the study design, statistical analyses, and reporting of cerebrovascular research. We assessed all original articles published in the Journal of Cerebral Blood Flow and Metabolism during the year 2008 against a checklist designed to capture the key attributes relating to study design, statistical analyses, and reporting. A total of 156 original publications were included (animal, in vitro, human). Few studies reported a primary research hypothesis, statement of purpose, or measures to safeguard internal validity (such as randomization, blinding, exclusion or inclusion criteria). Many studies lacked sufficient information regarding methods and results to form a reasonable judgment about their validity. In nearly 20% of studies, statistical tests were either not appropriate or information to allow assessment of appropriateness was lacking. This study identifies a number of factors that should be addressed if the quality of research in basic and translational biomedicine is to be improved. We support the widespread implementation of the ARRIVE (Animal Research Reporting In Vivo Experiments) statement for the reporting of experimental studies in biomedicine, for improving training in proper study design and analysis, and that reviewers and editors adopt a more constructively critical approach in the assessment of manuscripts for publication

Oral health improvement for nursing home residents through delegated remotivation and reinstruction (MundZaRR Study): study protocol of a cluster-randomised controlled trial

Introduction: Oral health and oral health-related quality of life (OHrQL) of residents in German long-term residential care (LRC) are poor. We will develop an evidence-based catalogue of interventions ('Oral Health Toolbox') and provide care-accompanying reinstruction and remotivation of nursing staff by dental assistants (DA). We hypothesise that such intervention will significantly improve OHrQL, daily oral hygiene/care behaviour and is cost-effective. Methods and analysis: A scoping review will be used to identify possible intervention components. Mixed methods will be used to identify barriers and enablers of oral hygiene and care in German LRC. The result will be the 'Oral Health Toolbox', a two-phased instrument supporting both initial intervention allocation to improve oral health/hygiene and reinstruction/remotivation. A two-arm clustered, randomised controlled trial (ratio of 1:1 via block randomisation) will be performed in LRC in Rhineland-Palatinate, Germany. Each nursing home represents a cluster. Based on a feasibility study, considering clustering and possible attrition, we aim at recruiting 618 residents in 18 clusters. In the intervention group, dentists will assign one or more intervention component from the box (phase 1). During follow-up, nursing staff will be reinstructed and remotivated by DA, who use the box to decide how to maintain the intervention (phase 2). In the control group residents will receive care as usual. The primary outcome, OHrQL, will be measured using the General Oral Health Assessment Index. Secondary outcomes include pain condition, general health-related quality of life, caries increment, oral/prosthetic hygiene and gingival status, incidence of dental emergencies and hospitalisations, and cost-utility/effectiveness. The endpoints will be measured at baseline and after 12 months. For our primary outcome, a mixed-linear model will be used within an intention-to-treat analysis. A process evaluation using mixed methods will be conducted alongside the trial. Ethics and dissemination: Ethical approval by the University of Kiel was granted (D480/18). Trial registration number: NCT04140929

Selective carious tissue removal using subjective criteria or polymer bur: study protocol for a randomised controlled trial (SelecCT)

Introduction: Selective (incomplete/partial) carious tissue removal is suitable for treating deep carious lesions in teeth with vital, asymptomatic pulps. In the periphery of a cavity, removal to hard dentin is performed, while in pulpo-proximal areas, leathery or soft dentin is left to avoid pulp exposure. As the decision of what contains 'soft' or 'leathery' dentin is subjective, using self-limiting burs which help to standardise the hardness of the remaining dentin, has been suggested to increase the reliability of carious tissue removal. The trial compares subjectively measured selective carious tissue removal in deep lesions in primary teeth with objectively measured selective removal with a self-limiting bur (Polybur, Komet). Methods and analysis: A community-based single-blind clustered randomised controlled superiority trial nested into a larger evaluation is performed. Recruitment for this trial has been concluded. We have recruited 115 children aged 6-8 years with >= 1 vital primary molar with a deep dentin lesion. The unit of randomisation was the child, with all eligible molars per child treated identically. Treatment was performed in a mobile dental unit. Subjective and objective carious tissue removal was performed at random. Teeth were restored using glass ionomer cement (Equia Forte, GC). Our primary outcome will be the time until complications occur, evaluated via multilevel survival analysis. Secondary outcomes will be the time until extraction is needed, subjective satisfaction of the child with the treatment (measured using a Likert scale) and cost-effectiveness. Re-examination will be performed after 12, 24 and 36 months (the final examination is expected in 2020). Ethics and dissemination: This trial has been approved by the Ethics Committee of the Health Sciences of the University of Brasilia (CAAE 51310415.0.0000.0030). Trial results will be published in peer-reviewed journals and presented on conferences