Sequential organ failure assessment score is an excellent operationalization of disease severity of adult patients with hospitalized community acquired pneumonia - results from the prospective observational PROGRESS study.

BACKGROUND: CAP (Community acquired pneumonia) is frequent, with a high mortality rate and a high burden on health care systems. Development of predictive biomarkers, new therapeutic concepts, and epidemiologic research require a valid, reproducible, and quantitative measure describing CAP severity. METHODS: Using time series data of 1532 patients enrolled in the PROGRESS study, we compared putative measures of CAP severity for their utility as an operationalization. Comparison was based on ability to correctly identify patients with an objectively severe state of disease (death or need for intensive care with at least one of the following: substantial respiratory support, treatment with catecholamines, or dialysis). We considered IDSA/ATS minor criteria, CRB-65, CURB-65, Halm criteria, qSOFA, PSI, SCAP, SIRS-Score, SMART-COP, and SOFA. RESULTS: SOFA significantly outperformed other scores in correctly identifying a severe state of disease at the day of enrollment (AUC = 0.948), mainly caused by higher discriminative power at higher score values. Runners-up were the sum of IDSA/ATS minor criteria (AUC = 0.916) and SCAP (AUC = 0.868). SOFA performed similarly well on subsequent study days (all AUC > 0.9) and across age groups. In univariate and multivariate analysis, age, sex, and pack-years significantly contributed to higher SOFA values whereas antibiosis before hospitalization predicted lower SOFA. CONCLUSIONS: SOFA score can serve as an excellent operationalization of CAP severity and is proposed as endpoint for biomarker and therapeutic studies. TRIAL REGISTRATION: clinicaltrials.gov NCT02782013 , May 25, 2016, retrospectively registered.

On the Conditional Power in Survival Time Analysis Considering Cure Fractions.

Conditional power of survival endpoints at interim analyses can support decisions on continuing a trial or stopping it for futility. When a cure fraction becomes apparent, conditional power cannot be calculated accurately using simple survival models, e.g. the exponential model. Non-mixture models consider such cure fractions. In this paper, we derive conditional power functions for non-mixture models, namely the non-mixture exponential, the non-mixture Weibull, and the non-mixture Gamma models. Formulae were implemented in the R package CP. For an example data set of a clinical trial, we calculated conditional power under the non-mixture models and compared results with those under the simple exponential model.

Clinical Efficacy of Azithromycin as an Adjunctive Therapy to Non-Surgical Periodontal Treatment of Periodontitis: A Systematic Review and Meta-Analysis.

INTRODUCTION: Over the years, numerous trials have sufficiently documented benefits of adjuvant administration of antibiotics in combination to Scaling and Root Planing (SRP) in treatment of periodontitis. Nevertheless there are justified doubts in respect to antibiotics administration with regard to increasing development of resistances. AIM: The aim of this review study and meta-analysis was to verify a possible benefit of Azithromycin (AZM) as an alternative adjuvant antibiotic in combination with SRP. MATERIALS AND METHODS: Electronic databases (Pubmed) were searched from the earliest point of record until May 2015. A hand search was also conducted. The variables considered in this respect were Probing Depth (PD), Clinical Attachment Level (CAL), Bleeding on Probing (BOP) and SRP. A meta-analysis containing trials comparing SRP as a sole therapy with SRP and administration of AZM was produced once all of the data obtained had been reviewed. RESULTS: Six randomised clinical trials were accepted into the review and the meta-analysis following the process of trial selection. Meta-analysis revealed larger overall effects by the systemic administration of AZM compared with SRP on their own in terms of PD, CAL, BOP, Plaque-Index and total bacterial load reduction after three and six months. CONCLUSION: The data used in this study revealed that the systemic administration of AZM is beneficial compared with SRP on its own for the treatment of chronic periodontitis.

Evaluation of a New Self-Reported Tool for Periodontitis Screening.

INTRODUCTION: Periodontitis is still highly prevalent in industrial population whereas at the same time appropriate screening programs are missing. AIM: To evaluate, a self-reported questionnaire about periodontal risk factors in combination with the Periodontal Screening Index (PSI) to identify an existing need for periodontal treatment combined with the early recognition of high-risk patients. MATERIALS AND METHODS: Total 200 patients took part in the questionnaire based study and were examined using the PSI. Thereafter the participants were divided into two groups, subjects with periodontitis (Group 1; PSI 0-2) and subjects without periodontitis (Group 2; PSI 3-4). The answers were evaluated using a point system ranging from 0 to 8, based on known periodontal risk factors and their assumed degree of influence. Receiver-Operating Characteristic (ROC) curve analysis were applied to examine the overall discriminatory power, sensitivity, specificity and corresponding cut-off points of the self-reported periodontal disease scale. RESULTS: There was a significant difference between Group 1 and 2 concerning the majority of the inquired items (12 of 16, p<0.05). The distribution of the individual total score exhibited a high statistical significance (p<0.001) of robustness in terms of differing definitions of periodontitis. The Area Under the Curve (AUC) was 0.912 with a sensitivity of 86% and a specificity of 76%. CONCLUSION: The questionnaire produced a reliable assessment of the individual risk (total score) and the need for periodontal treatment as well as the differentiation between gingivitis and periodontitis. CLINICAL RELEVANCE: Patient-based data (clinical variables and periodontal risk factors of periodontitis) were adequate to make a preliminary assessment of a possible need for periodontal treatment.

Evaluation of an Electronic Periodontal Probe Versus a Manual Probe.

INTRODUCTION: Diagnosis of periodontal diseases requires reco-rding of clinical and periodontal variables. Possible measurement errors in recording the periodontal findings are dependent on the measurement method. AIM: The purpose of the trial was to investigate an electronic, pressure-calibrated probe compared with a standard, manual measurement probe used to take periodontal variables. MATERIALS AND METHODS: The study included 25 subjects suffering from periodontal disease. Their findings were taken by two users on a randomized basis using a standard probe and an electronic, pressure calibrated probe, at an interval of 24 hours. The recorded clinical variables contained Pocket Depth (PD), Attachment Level (AL), Bleeding on Probing (BOP), the complete time needed to take the findings and the sensation of pain experienced by a Visual Analogue Scale (VAS). The data were statistically analyzed using the paired t-test. RESULTS: The measurement values (24 patients) for PD (p=0.03) and BOP (p=0.01) indicated a significant difference (paired t test, p>0.05), while there was no statistical difference for AL (p=0.064). A classification of PD into groups of 1-3mm, 4-6mm and ≥7mm showed that the manual method measured higher values than the electronic method (p=0.001). The measurement values did not reveal any significant differences (p>0.05) with respect to the total time needed to take findings and the measurement time for PD/AL. There was a significant difference (Wilcoxon-test, p<0.05) in VAS values (p=0.048) and in terms of the time needed to record the findings for BOP (p=0.004). CONCLUSION: It can be assumed that the electronic probe should mainly be used in the supportive periodontal therapy. Present study showed that the use of a standard manual probe is essential to review conspicuous or unclear measurement values, or when treating deep pockets higher than 7mm.