@article{NeudeckerMalzahnHeuschmannetal.2015, author = {Neudecker, Jens and Malzahn, Uwe and Heuschmann, Peter and Behrens, Uwe and Walles, Thorsten}, title = {Pulmonary wedge resection plus parietal pleurectomy (WRPP) versus parietal pleurectomy (PP) for the treatment of recurrent primary pneumothorax (WOPP trial): study protocol for a randomized controlled trial}, series = {Trials}, volume = {16}, journal = {Trials}, doi = {10.1186/s13063-015-1060-z}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-145869}, pages = {540}, year = {2015}, abstract = {Background For the surgical treatment of recurrent primary spontaneous pneumothoraces (rPSP) different operative therapies are applied to achieve permanent freedom from recurrence. Methods/design This multicenter clinical trial evaluates the long-term results of two commonly applied surgical techniques for the treatment of rPSP. Based on the inclusion and exclusion criteria, and after obtaining the patients' informed consent, participants are randomized into the two surgical treatment arms: pulmonary wedge resection plus parietal pleurectomy (WRPP) or parietal pleurectomy alone (PP). Consecutively, all study participants will be followed up for two years to evaluate the surgical long-term effect. The primary efficacy endpoint is the recurrence rate of pneumothorax within 24 months after surgery. The calculated sample size is 360 patients (n = 180 per treatment arm) to prove superiority of one of the two treatments. So far, 22 surgical sites have submitted their declaration of commitment, giving the estimated number of participating patients. Discussion A prospective randomized clinical trial has been started to compare two established surgical therapies to evaluate the long-term results regarding recurrence rates. Furthermore, cost of treatment, and influence on the perioperative morbidity and mortality as well as on quality of life are analyzed. If the study reveals equivalence for both surgical techniques, unnecessary pulmonary resections could be avoided.}, language = {en} } @article{MaggRieglerWiedmannetal.2015, author = {Magg, Barbara and Riegler, Christoph and Wiedmann, Silke and Heuschmann, Peter and Sommer, Claudia and {\"U}{\c{c}}eyler, Nurcan}, title = {Self-administered version of the Fabry-associated pain questionnaire for adult patients}, series = {Orphanet Journal of Rare Diseases}, volume = {10}, journal = {Orphanet Journal of Rare Diseases}, number = {113}, doi = {10.1186/s13023-015-0325-7}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-145294}, year = {2015}, abstract = {Background Fabry-associated pain may be the first symptom of Fabry disease (FD) and presents with a unique phenotype including mostly acral burning triggerable pain attacks, evoked pain, pain crises, and permanent pain. We recently developed and validated the first Fabry Pain Questionnaire (FPQ) for adult patients. Here we report on the validation of the self-administered version of the FPQ that no longer requires a face-to-face interview but can be filled in by the patients themselves allowing more flexible data collection. Methods At our W{\"u}rzburg Fabry Center for Interdisciplinary Treatment, Germany, we have developed the self-administered version of the FPQ by adapting the questionnaire to a self-report version. To do this, consecutive Fabry patients with current or past pain history (n = 56) were first interviewed face-to-face. Two weeks later patients' self-reported questionnaire results were collected by mail (n = 55). We validated the self-administered version of the FPQ by assessing the inter-rater reliability agreement of scores obtained by supervised administration and self-administration of the FPQ. Results The FPQ contains 15 questions on the different pain phenotypes, on pain development during life with and without therapy, and on impairment due to pain. Statistical analysis showed that the majority of questions were answered in high agreement in both sessions with a mean AC1-statistic of 0.857 for 55 nominal-scaled items and a mean ICC of 0.587 for 9 scores. Conclusions This self-administered version of the first pain questionnaire for adult Fabry patients is a useful tool to assess Fabry-associated pain without a time-consuming face-to-face interview but via a self-reporting survey allowing more flexible usage.}, language = {en} } @article{GybergDeBacquerDeBackeretal.2015, author = {Gyberg, Viveca and De Bacquer, Dirk and De Backer, Guy and Jennings, Catriona and Kotseva, Kornelia and Mellbin, Linda and Schnell, Oliver and Tuomilehto, Jaakko and Wood, David and Ryden, Lars and Amouyel, Philippe and Bruthans, Jan and Conde, Almudena Castro and Cifkova, Renata and Deckers, Jaap W. and De Sutter, Johan and Dilic, Mirza and Dolzhenko, Maryna and Erglis, Andrejs and Fras, Zlatko and Gaita, Dan and Gotcheva, Nina and Goudevenos, John and Heuschmann, Peter and Laucevicius, Aleksandras and Lehto, Seppo and Lovic, Dragan and Milicic, Davor and Moore, David and Nicolaides, Evagoras and Oganov, Raphae and Pajak, Andrzej and Pogosova, Nana and Reiner, Zeljko and Stagmo, Martin and St{\"o}rk, Stefan and Tokg{\"o}zoglu, Lale and Vulic, Dusko}, title = {Patients with coronary artery disease and diabetes need improved management: a report from the EUROASPIRE IV survey: a registry from the EuroObservational Research Programme of the European Society of Cardiology}, series = {Cardiovascular Diabetology}, volume = {14}, journal = {Cardiovascular Diabetology}, number = {133}, doi = {10.1186/s12933-015-0296-y}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-141358}, year = {2015}, abstract = {Background: In order to influence every day clinical practice professional organisations issue management guidelines. Cross-sectional surveys are used to evaluate the implementation of such guidelines. The present survey investigated screening for glucose perturbations in people with coronary artery disease and compared patients with known and newly detected type 2 diabetes with those without diabetes in terms of their life-style and pharmacological risk factor management in relation to contemporary European guidelines. Methods: A total of 6187 patients (18-80 years) with coronary artery disease and known glycaemic status based on a self reported history of diabetes (previously known diabetes) or the results of an oral glucose tolerance test and HbA1c (no diabetes or newly diagnosed diabetes) were investigated in EUROASPIRE IV including patients in 24 European countries 2012-2013. The patients were interviewed and investigated in order to enable a comparison between their actual risk factor control with that recommended in current European management guidelines and the outcome in previously conducted surveys. Results: A total of 2846 (46 \%) patients had no diabetes, 1158 (19 \%) newly diagnosed diabetes and 2183 (35 \%) previously known diabetes. The combined use of all four cardioprotective drugs in these groups was 53, 55 and 60 \%, respectively. A blood pressure target of <140/90 mmHg was achieved in 68, 61, 54 \% and a LDL-cholesterol target of <1.8 mmol/L in 16, 18 and 28 \%. Patients with newly diagnosed and previously known diabetes reached an HbA1c <7.0 \% (53 mmol/mol) in 95 and 53 \% and 11 \% of those with previously known diabetes had an HbA1c >9.0 \% (>75 mmol/mol). Of the patients with diabetes 69 \% reported on low physical activity. The proportion of patients participating in cardiac rehabilitation programmes was low (approximate to 40 \%) and only 27 \% of those with diabetes had attended diabetes schools. Compared with data from previous surveys the use of cardioprotective drugs had increased and more patients were achieving the risk factor treatment targets. Conclusions: Despite advances in patient management there is further potential to improve both the detection and management of patients with diabetes and coronary artery disease.}, language = {en} }