Quality indicators for measuring the level of patients' involvement in the pharmaceutical care process

Patient-centred counseling is an integral part of the pharmaceutical care process. Quality in- dicators can be valuable tools to measure the level of patients’ involvement in their personal healthcare. The aim of the study was to validate two quality indicators for community pharmacy care focusing on patient involvement. As part of the EDQM Pharmaceutical Care Quality Indicators Project (Council of Europe), at least 10 patients per indicator were recruited in each community pharmacy in Serbia and Po- land. Pharmacists targeted patients aged 18-65 years starting chronic treatment (Indicator 1) and elderly patients with polymorbidity receiving at least five chronic treatment medicines (Indicator 2). Based on patients’ answers to a questionnaire, patient-pharmacist consultations took place. For Indicator 2, patients were also offered a medication review. In total, 66% of Serbian patients and 29% Polish patients, for In- dicator 1, were engaged in pharmacist-patient consultations; 96% of Serbian and 84% of Polish elderly patients subsequently participated in medication reviews. Community pharmacists can increase patients’ involvement in their own pharmaceutical care, and there is a need for such services. This study defines a pragmatic approach to encourage/support the implementation of the pharmaceutical care philosophy and working methods in European community pharmacies

The development and appraisal of a tool designed to find patients harmed by falsely labelled, falsified (counterfeit) medicines.

To access publisher's full text version of this article, please click on the hyperlink in Additional Links field or click on the hyperlink at the top of the page marked FilesFalsely labelled, falsified (counterfeit) medicines (FFCm's) are produced or distributed illegally and can harm patients. Although the occurrence of FFCm's is increasing in Europe, harm is rarely reported. The European Directorate for the Quality of Medicines & Health-Care (EDQM) has therefore coordinated the development and validation of a screening tool.The tool consists of a questionnaire referring to a watch-list of FFCm's identified in Europe, including symptoms of their use and individual risk factors, and a scoring form. To refine the questionnaire and reference method, a pilot-study was performed in 105 self-reported users of watch-list medicines. Subsequently, the tool was validated under "real-life conditions" in 371 patients in 5 ambulatory and in-patient care sites ("sub-studies"). The physicians participating in the study scored the patients and classified their risk of harm as "unlikely" or "probable" (cut-off level: presence of ≥2 of 5 risk factors). They assessed all medical records retrospectively (independent reference method) to validate the risk classification and documented their perception of the tool's value.In 3 ambulatory care sites (180 patients), the tool correctly classified 5 patients as harmed by FFCm's. The positive and negative likelihood ratios (LR+/LR-) and the discrimination power were calculated for two cut-off levels: a) 1 site (50 patients): presence of two risk factors (at 10% estimated health care system contamination with FFCm's): LR + 4.9/LR-0, post-test probability: 35%; b) 2 sites (130 patients): presence of three risk factors (at 5% estimated prevalence of use of non-prescribed medicines (FFCm's) by certain risk groups): LR + 9.7/LR-0, post-test probability: 33%. In 2 in-patient care sites (191 patients), no patient was confirmed as harmed by FFCm's. The physicians perceived the tool as valuable for finding harm, and as an information source regarding risk factors.This "decision aid" is a systematic tool which helps find in medical practice patients harmed by FFCm's. This study supports its value in ambulatory care in regions with health care system contamination and in certain risk groups. The establishment of systematic communication between authorities and the medical community concerning FFCm's, current patterns of use and case reports may sustain positive public health impacts.EDQ

Dosimetric influence of deformable image registration uncertainties on propagated structures for online daily adaptive proton therapy of lung cancer patients

Purpose: A major burden of introducing an online daily adaptive proton therapy (DAPT) workflow is the time and resources needed to correct the daily propagated contours. In this study, we evaluated the dosimetric impact of neglecting the online correction of the propagated contours in a DAPT workflow.Material and methods: For five NSCLC patients with nine repeated deep-inspiration breath-hold CTs, proton therapy plans were optimised on the planning CT to deliver 60 Gy-RBE in 30 fractions. All repeated CTs were registered with six different clinically used deformable image registration (DIR) algorithms to the corresponding planning CT. Structures were propagated rigidly and with each DIR algorithm and reference structures were contoured on each repeated CT. DAPT plans were optimised with the uncorrected, propagated structures (propagated DAPT doses) and on the reference structures (ideal DAPT doses), nonadapted doses were recalculated on all repeated CTs.Results: Due to anatomical changes occurring during the therapy, the clinical target volume (CTV) coverage of the non-adapted doses reduces on average by 9.7% (V95) compared to an ideal DAPT doses. For the propagated DAPT doses, the CTV coverage was always restored (average differences in the CTV V95 &lt; 1% compared to the ideal DAPT doses). Hotspots were always reduced with any DAPT approach.Conclusion: For the patients presented here, a benefit of online DAPT was shown, even if the daily optimisation is based on propagated structures with some residual uncertainties. However, a careful (offline) structure review is necessary and corrections can be included in an offline adaption.(c) 2021 The Author(s). Published by Elsevier B.V. Radiotherapy and Oncology 159 (2021) 136-143 This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).</p

Quantitative und qualitative Analyse des Lehrverhaltens didaktisch qualifizierter studentischer Tutoren im makroskopisch-anatomischen Kurs

Fragestellung: Der Einsatz studentischer TutorInnen im makroskopisch- anatomischen Kurs (MAK) hat eine lange Historie, jedoch werden diese, wenn überhaupt nur anatomisch, nicht aber didaktisch, vor Beginn des Kurses ausgebildet. Bis dato gibt es wenige Informationen darüber, welchen Tätigkeiten und Aufgaben die TutorInnen im MAK tatsächlich nachgehen und ob diese damit den möglichen Erwartungen z.B. der Kursleitung oder der Studierenden gerecht werden. In dieser Studie wird zum Einen ein didaktisches Qualifizierungsprogramm für studentische TutorInnen „Train- the-Tutor“ vorgestellt, zum Anderen ermittelt, welchen konkreten Aufgaben und Tätigkeiten die durch dieses Programm qualifizierten Near-Peer-Teacher (NPT) im MAK nachgehen, um daraus ein entsprechendes Tätigkeitsprofil zu erstellen. Des Weiteren erhofften wir uns, Rückschlüsse für die Weiterentwicklung des Train-the-Tutor-Programms (TtT) in der Zukunft ziehen zu können. Material und Methoden: Zur quantitativen sowie qualitativen Analyse wurden insgesamt 565 halbstrukturierte Kurzprotokolle ausgewertet, welche die 23 didaktisch geschulten NPTs an allen 25 Kurstagen des MAK im Wintersemester 2012/2013 an der Universität Ulm ausgefüllt hatten. Die Informationen zu ihrer Tätigkeit im MAK wurden von den NPTs sowohl in Freitextform, als auch in Form von quantifizierbaren Kreisdiagrammen dokumentiert. Die qualitative Datenanalyse erfolgte mit Hilfe der Grounded- Theory-Methode. Alle Daten wurden mit Hilfe einer lizensierten Version der SPSS-Software digitalisiert, quantifiziert und schließlich zum Teil deskriptiv präsentiert bzw. die zu unseren Fragestellungen formulierten Hypothesen mit ausgewählten statistischen Testverfahren analysiert. Ergebnisse: Das Tätigkeitsprofil der NPTs zeigte, dass diese im Mittel über die gesamte Kurszeit zu 36,1% die Präparation der Studierenden beaufsichtigten und zu 25% selber präparierten. Sie gingen zu 20,4% sonstigen Aufgaben (z.B. Probetestat) nach, nahmen zu 10,5% organisatorische Aufgaben wahr und widmeten sich zu 7,8% dem Geben von Feedback an die TN. In der longitudinalen Analyse zeichnete sich ab, dass die NPTs in der zweiten Kurshälfte signifikant weniger die Präparation der Studierenden beaufsichtigten als in der 1. Kurshälfte. Umgekehrtes gilt für die Tätigkeit „Sonstiges“. Gerade am Kurstag vor Lernkontrollen (Testate) konnte ein Anstieg sonstiger Tätigkeiten verzeichnet werden sowie ebenfalls ein Anstieg des Gebens von Feedback an die TN. Die qualitative Datenanalyse ergab, dass 45% aller positiven Nennungen zum Umgang mit den Studierenden erfolgten, wohingegen sich 68% der negativen Nennungen auf die Reflexion der eigenen Rolle als TutorIn bezogen. Die NPTs befassten sich mit allen drei Lernzieldomänen, am häufigsten jedoch mit der Lernzieldomäne „Attitudes“. Diskussion: Das Tätigkeitsprofil zeigt, dass NPTs im MAK mehr als die Hälfte der Zeit arbeiten und damit den Erfordernissen eines Praktikums gerecht werden. Es wurde deutlich, dass NPTs in der Lage sind, ihre Tätigkeiten der Dynamik des Kursverlaufes flexibel anzupassen. Sie können durch ihre lehrende Tätigkeit das Fachpersonal insbesondere in den Bereichen Organisation und Präparation entlasten und sind unterstützend für einen optimalen Kursbetrieb. Insbesondere die qualitativen Daten belegen eine hohe Reflexionsfähigkeit der TutorInnen über Bedürfnisse und Haltungen der von ihnen betreuten Studierenden, sowie zur kritischen Ausseinandersetzung mit ihrer eigenen Rolle als TutorIn. Im Bereich der Lernzieldomäne „Attitudes“ sollten die künftigen NPTs im Rahmen des TtT-Programmes vermehrt Unterstützung erhalten. Außerdem sollte die Kursstruktur, insofern umsetzbar, auf eine mögliche Verbesserung der äußeren Rahmenbedingen hin überprüft und angepasst werden

Association of urinary phytoestrogen concentrations with serum concentrations of prostate-specific antigen in the National Health and Nutrition Examination Survey

Some clinical trials have shown that high phytoestrogen intake may decrease serum concentrations of prostate-specific antigen (PSA), and phytoestrogens may also lower prostate cancer risk. It was the aim of this study to examine the relationship between the serum PSA level and urine phytoestrogen concentration in generally healthy U.S. men. Eight hundred twenty-four men, 40+ yr old without prostate cancer, who participated in the 2001-2004 NHANES surveys, were included in the analysis. The association of total PSA, free PSA, and PSA ratio [free PSA/total PSA * 100] with concentrations of isoflavones and lignans (standardized for urinary creatinine concentration) was examined using multivariable-adjusted linear and logistic regression models. The linear regression analyses showed no clear association between creatinine-standardized urinary phytoestrogen concentrations and serum total or free PSA levels or PSA ratio. However, the odds of having a PSA ratio <15% rose from Quartile 1 to Quartile 4 of isoflavone excretion (odds ratio = 2.82, 95% confidence interval 1.28-6.22 for top vs. bottom quartile), but there were no associations with having a PSA ratio <25%. In generally healthy U.S. men, 40+ yr old without a diagnosis of prostate cancer, urinary isoflavone, and lignan concentrations were not associated with serum PSA level

Urinary phytoestrogen levels and frailty in older American women and the National Health and Nutrition Examination Survey (NHANES) 1999-2002: a cross-sectional study

Background/Aims: A deficit of various hormones during the process of aging and/or a heightened inflammatory state may be causally linked to the development of frailty. Phytoestrogens as weak estrogens, antioxidants, and anti-inflammatory agents may counteract this process. Methods: In a cross-sectional study including two cycles of the National Health and Nutrition Examination Survey (NHANES, i.e. 1999-2002), logistic regression was used to analyze the association between urinary concentrations of isoflavones and lignans and frailty in 600 females aged 50 years or older (median age 66.5 years). Participants were classified as &#39;frail&#39; (meeting 3 or more of the 5 frailty criteria), &#39;prefrail&#39; (meeting 1 or 2 of the criteria), or &#39;robust&#39; (meeting none of the criteria). Four percent were frail. Results: For all of the phytoestrogens considered, the unadjusted OR were lower than 1 but generally not statistically significant aside from the association with O-desmethylangolensin (O-DMA) (OR = 0.76; 95% CI 0.61-0.92). Multivariate analysis did not attenuate this finding (OR = 0.74; 95% CI 0.61-0.90). Conclusions: This first analysis of the relationship between phytoestrogens and frailty revealed an inverse association between urinary O-DMA levels and frailty in women. However, the number of frail women was low. Although this finding may be confounded or biased, it seems worthwhile to intensify research on the potential preventive effects of O-DMA

Archimedes’ principle for characterisation of recombinant whole cell biocatalysts

The ability of whole cells to catalyse multistep reactions, often yielding synthetically demanding compounds later used by industrial biotech or pharma, makes them an indispensable tool of synthetic chemistry. The complex reaction network employed by cellular catalysts and the still only moderate predictive power of modelling approaches leaves this tool challenging to engineer. Frequently, large libraries of semi-rationally generated variants are sampled in high-throughput mode in order to then identify improved catalysts. We present a method for space- and time-efficient processing of very large libraries (10^7) of recombinant cellular catalysts, in which the phenotypic characterisation and the isolation of positive variants for the entire library is done within one minute in a single, highly parallelized operation. Specifically, product formation in nanolitre-sized cultivation vessels is sensed and translated into the formation of catalase as a reporter protein. Exposure to hydrogen peroxide leads to oxygen gas formation and thus to a density shift of the cultivation vessel. Exploiting Archimedes’ principle, this density shift and the resulting upward buoyancy force can be used for batch-wise library sampling. We demonstrate the potential of the method for both, screening and selection protocols, and envision a wide applicability of the system for biosensor-based assays.ISSN:2045-232

Analysis of AET and yield predictions under surface and buried drip irrigation systems using the Crop Model PILOTE and Hydrus-2D

Innovative irrigation solutions have to face water scarcity problems affecting the Mediterranean countries. Generally, surface (DI) or subsurface drip irrigation systems (SDI) have the ability to increase water productivity (WP). But the question about their possible utilisation for crops such as corn would merit to be analysed using an appropriate economic tool. The latter would be necessary based on the utilisation of a modelling approach to identify the optimal irrigation strategy associating a water amount with a crop yield (Yc). In this perspective, a possible utilisation of the operative 1D crop model PILOTE for simulating actual evapotranspiration (AET) and yield under a 2D soil water transfer process characterizing DI and SDI was analysed. In this study, limited to a loamy soil cultivated with corn, the pertinence of the root water uptake model used in the numerical code Hydrus-2D for AET estimations of actual evapotranspiration (AET) under water stress conditions is discussed throughout the Yc = F(AET) relationship established by PILOTE on the basis of validated simulations. The conclusions of this work are (i): with slight adaptations, PILOTE can provide reliable WP estimations associated to irrigation strategies under DI and SDI, (ii): the current Hydrus-2D version used in this study underestimates AET, compared with PILOTE, in a range varying from 7% under moderate water stress conditions to 14% under severe ones, (iii): A lateral spacing of 1.6 m for the irrigation of corn with a SDI system is an appropriate solution on a loamy soil under a Mediterranean climate. A local Yc = F(AET) relationship associated with a Hydrus-2D version taking into account the compensating root uptake process could result in an interesting tool to help identify the optimal irrigation system design under different soil conditions.Actual evapotranspiration Crop model Drip irrigation Hydrus-2D