@article{SenjuMukainoProdingeretal.2021, author = {Senju, Y and Mukaino, M and Prodinger, Birgit and Selb, M and Okouchi, Y and Mizutani, K and Suzuki, M and Yamada, S and Izumi, SI and Sonoda, S and Otaka, Y and Saitoh, E and Stucki, G}, title = {Development of a clinical tool for rating the body function categories of the ICF generic-30/rehabilitation set in Japanese rehabilitation practice and examination of its interrater reliability}, series = {BMC Medical Research Methodology}, volume = {21}, journal = {BMC Medical Research Methodology}, number = {1}, pages = {121}, year = {2021}, abstract = {Background: The International Classification of Functioning, Disability, and Health (ICF) Generic-30 (Rehabilitation) Set is a tool used to assess the functioning of a clinical population in rehabilitation. The ICF Generic-30 consists of nine ICF categories from the component "body functions" and 21 from the component "activities and participation". This study aimed to develop a rating reference guide for the nine body function categories of the ICF Generic-30 Set using a predefined, structured process and to examine the interrater reliability of the ratings using the rating reference guide. Methods: The development of the first version of the rating reference guide involved the following steps: (1) a trial of rating patients by several raters; (2) cognitive interviews with each rater to analyze the thought process involved in each rating; (3) the drafting of the rating reference guide by a multidisciplinary panel; and (4) a review by ICF specialists to confirm consistency with the ICF. Subsequently, we conducted a first field test to gain insight into the use of the guide in practice. The reference guide was modified based on the raters' feedback in the field test, and an inter-rater reliability test was conducted thereafter. Interrater agreement was evaluated using weighted kappa statistics with linear weights. Results: The first version of the rating reference guide was successfully developed and tested. The weighted kappa coefficient in the field testing ranged from 0.25 to 0.92. The interrater reliability testing of the rating reference guide modified based on the field test results yielded an improved weighted kappa coefficient ranging from 0.53 to 0.78. Relative improvements in the weighted kappa coefficients were observed in seven out of the nine categories. Consequently, seven out of nine categories were found to have a weighted kappa coefficient of 0.61 or higher. Conclusions: In this study, we developed and modified a rating reference guide for the body function categories of the ICF Generic-30 Set. The interrater reliability test using the final version of the rating reference guide showed moderate to substantial interrater agreement, which encouraged the use of the ICF in rehabilitation practice.}, language = {en} } @article{SecklerRegauerKruegeretal.2021, author = {Seckler, Eva and Regauer, Verena and Kr{\"u}ger, Melanie and Gabriel, Anna and Hermsd{\"o}rfer, Joachim and Niemietz, Carolin and Bauer, Petra and M{\"u}ller, Martin}, title = {Improving mobility and participation of older people with vertigo, dizziness and balance disorders in primary care using a care pathway: feasibility study and process evaluation}, series = {BMC Family Practice}, volume = {22}, journal = {BMC Family Practice}, pages = {62}, year = {2021}, abstract = {Background Community-dwelling older people are frequently affected by vertigo, dizziness and balance disorders (VDB). We previously developed a care pathway (CPW) to improve their mobility and participation by offering standardized approaches for general practitioners (GPs) and physical therapists (PTs). We aimed to assess the feasibility of the intervention, its implementation strategy and the study procedures in preparation for the subsequent main trial. Methods This 12-week prospective cohort feasibility study was accompanied by a process evaluation designed according to the UK Medical Research Council's Guidance for developing and evaluating complex interventions. Patients with VDB (≥65 years), GPs and PTs in primary care were included. The intervention consisted of a diagnostic screening checklist for GPs and a guide for PTs. The implementation strategy included specific educational trainings and a telephone helpline. Data for mixed-method process evaluation were collected via standardized questionnaires, field notes and qualitative interviews. Quantitative data were analysed using descriptive statistics, qualitative data using content analysis. Results A total of five GP practices (seven single GPs), 10 PT practices and 22 patients were included in the study. The recruitment of GPs and patients was challenging (response rates: GP practices: 28\%, PT practices: 39\%). Ninety-one percent of the patients and all health professionals completed the study. The health professionals responded well to the educational trainings; the utilization of the telephone helpline was low (one call each from GPs and PTs). Familiarisation with the routine of application of the intervention and positive attitudes were emphasized as facilitators of the implementation of the intervention, whereas a lack of time was mentioned as a barrier. Despite difficulties in the GPs' adherence to the intervention protocol, the GPs, PTs and patients saw benefit in the intervention. The patients' treatment adherence to physical therapy was good. There were minor issues in data collection, but no unintended consequences. Conclusion Although the process evaluation provided good support for the feasibility of study procedures, the intervention and its implementation strategy, we identified a need for improvement in recruitment of participants, the GP intervention part and the data collection procedures. The findings will inform the main trial to test the interventions effectiveness in a cluster RCT. Trial registration Projektdatenbank Versorgungsforschung Deutschland (German registry Health Services Research) VfD_MobilE-PHY_17_003910, date of registration: 30.11.2017; Deutsches Register Klinischer Studien (German Clinical Trials Register) DRKS00022918, date of registration: 03.09.2020 (retrospectively registered).}, language = {en} } @article{RegauerSecklerGrilletal.2021, author = {Regauer, Verena and Seckler, Eva and Grill, Eva and Ippisch, Richard and Jahn, Klaus and Bauer, Petra and M{\"u}ller, Martin}, title = {Development of a complex intervention to improve mobility and participation of older people with vertigo, dizziness and balance disorders in primary care: a mixed methods study}, series = {BMC Family Practice}, volume = {22}, journal = {BMC Family Practice}, pages = {89}, year = {2021}, abstract = {Background Vertigo, dizziness and balance disorders (VDB) are common in older people and cause restrictions in mobility and social participation. Due to a multifactorial aetiology, health care is often overutilised, but many patients are also treated insufficiently in primary care. The purpose of this study was to develop a care pathway as a complex intervention to improve mobility and participation in older people with VDB in primary care. Methods The development process followed the UK Medical Research Council guidance using a mixed-methods design with individual and group interviews carried out with patients, physical therapists (PTs), general practitioners (GPs), nurses working in community care and a multi-professional expert panel to create a first draft of a care pathway (CPW) and implementation strategy using the Consolidated Framework of Implementation Research and the Expert recommendations for Implementing Change. Subsequently, small expert group modelling of specific components of the CPW was carried out, with GPs, medical specialists and PTs. The Behaviour Change Wheel was applied to design the intervention´s approach to behaviour change. To derive theoretical assumptions, we adopted Kellogg´s Logic Model to consolidate the hypothesized chain of causes leading to patient-relevant outcomes. Results Individual interviews with patients showed that VDB symptoms need to be taken more seriously by GPs. Patients demanded age-specific treatment offers, group sessions or a continuous mentoring by a PT. GPs required a specific guideline for diagnostics and treatment options including psychosocial interventions. Specific assignment to and a standardized approach during physical therapy were desired by PTs. Nurses favoured a multi-professional documentation system. The structured three-day expert workshop resulted in a first draft of CPW and potential implementation strategies. Subsequent modelling resulted in a CPW with components and appropriate training materials for involved health professionals. A specific implementation strategy is now available. Conclusion A mixed-methods design was suggested to be a suitable approach to develop a complex intervention and its implementation strategy. We will subsequently test the intervention for its acceptability and feasibility in a feasibility study accompanied by a comprehensive process evaluation to inform a subsequent effectiveness trial. Trial Registration The research project is registered in "Projektdatenbank Versorgungsforschung Deutschland" (Project-ID: VfD_MobilE-PHY_17_003910; date of registration: 30.11.2017).}, language = {en} } @article{RegauerSecklerCampbelletal.2021, author = {Regauer, Verena and Seckler, Eva and Campbell, Craig and Phillips, Amanda and Rotter, Thomas and Bauer, Petra and M{\"u}ller, Martin}, title = {German translation and pre-testing of Consolidated Framework for Implementation Research (CFIR) and Expert Recommendations for Implementing Change (ERIC)}, series = {Implementation Science Communications}, volume = {2}, journal = {Implementation Science Communications}, pages = {120}, year = {2021}, abstract = {Background Implementation frameworks may support local implementation strategies with a sound theoretical foundation. The Consolidated Framework for Implementation Research (CFIR) facilitates identification of contextual barriers and facilitators, and the Expert Recommendations for Implementing Change (ERIC) allows identifying adequate implementation strategies. Both instruments are already used in German-speaking countries; however, no standardised and validated translation is available thus far. The aim of this study was to translate the CFIR and ERIC framework into German, in order to increase the use of these frameworks and the adherence to evidence-based implementation efforts in German-speaking countries. Methods The translation of the original versions of the CFIR and ERIC framework was guided by the World Health Organisation's recommendations for the process of translating and adapting both conceptual frameworks. Accordingly, a four-step process was employed: first, forward translation from English into German was conducted by a research team of German native speakers with fluent knowledge of the English language. Second, a bilingual expert panel comprising one researcher with German as his mother tongue and expert command of the English language and one English language expert and university teacher reviewed the translation and discussed inconsistencies with the initial translators. Third, back-translation into English was conducted by an English native speaking researcher. The final version was pre-tested with 12 German researchers and clinicians who were involved in implementation projects using cognitive interviews. Results The translation and review process revealed some inconsistencies between the original version and the German translations. All issues could be solved by discussion. Central aspects of the items were confirmed in 60 to 70\% of the items, and modifications were proposed in 30\% of the items. Finally, we revised one CFIR-item heading after pre-testing. The final version was given consent by all involved parties. Conclusions Now, two validated and tested implementation frameworks to guide implementation efforts are available in the German language and can be used to increase the application of agreed-on implementation strategies into practice.}, language = {en} } @article{NicolYuSelbetal.2021, author = {Nicol, R and Yu, H and Selb, M and Prodinger, Birgit and Hartvigsen, J and C{\^o}t{\´e}, P}, title = {How Does the Measurement of Disability in Low Back Pain Map Unto the International Classification of Functioning, Disability and Health?: A Scoping Review of the Manual Medicine Literature}, series = {American Journal of Physical Medicine \& Rehabilitation}, volume = {100}, journal = {American Journal of Physical Medicine \& Rehabilitation}, number = {4}, pages = {367 -- 395}, year = {2021}, abstract = {The objective of this study was to catalog items from instruments used to measure functioning, disability, and contextual factors in patients with low back pain treated with manual medicine (manipulation and mobilization) according to the International Classification of Functioning, Disability and Health. This catalog will be used to inform the development of an International Classification of Functioning, Disability and Health-based assessment schedule for low back pain patients treated with manual medicine. In this scoping review, we systematically searched MEDLINE, Embase, PsycINFO, and CINAHL. We identified instruments (questionnaires, clinical tests, single questions) used to measure functioning, disability, and contextual factors, extracted the relevant items, and then linked these items to the International Classification of Functioning, Disability and Health. We included 95 articles and identified 1510 meaningful concepts. All but 70 items were linked to the International Classification of Functioning, Disability and Health. Of the concepts linked to the International Classification of Functioning, Disability and Health, body functions accounted for 34.7\%, body structures accounted for 0\%, activities and participation accounted for 41\%, environmental factors accounted for 3.6\%, and personal factors accounted for 16\%. Most items used to measure functioning and disability in low back pain patient treated with manual medicine focus on body functions, as well as activities and participation. The lack of measures that address environmental factors warrants further investigation.}, language = {en} } @article{LinkHostmannshoffMuelleretal.2021, author = {Link, Friederike and Hostmannshoff, Caren and M{\"u}ller, Martin and L{\"u}ftl, Katharina}, title = {Wissenschaftliche Karriere bis zur HAW-Professur in pflegebezogenen Studieng{\"a}ngen - Ziel oder Kompromiss? Ergebnisse einer Befragung wissenschaftlicher Nachwuchskr{\"a}fte an unterschiedlichen Etappen des Karriereweges}, series = {Lehren \& Lernen im Gesundheitswesen}, volume = {2021}, journal = {Lehren \& Lernen im Gesundheitswesen}, number = {6}, pages = {73 -- 86}, year = {2021}, abstract = {Die Pflegewissenschaft in Deutschland steht vor der Herausforderung, wissenschaftliche Strukturen und Karrierewege auszubilden. Erschwert wird dies durch einen Mangel an wissenschaftlichem Nachwuchs, der das Potential hat, pflegewissenschaftliche Professuren mit wissenschaftlicher Exzellenz und praktischer Erfahrung zu f{\"u}llen. Ziel dieses Beitrags ist es, darzustellen, was ausl{\"o}sende Momente f{\"u}r wissenschaftliche Karrieren sind, die in Professuren pflegebezogener Studieng{\"a}nge m{\"u}nden, und welche Kontextbedingungen diese Karrieren beeinflussen. Es soll auch aufgezeigt werden, wie wissenschaftliche Nachwuchskr{\"a}fte vorgehen, um ihre Ziele zu erreichen und welche Konsequenzen sich daraus f{\"u}r sie und f{\"u}r die Pflegewissenschaft ergeben. Auf dieser Grundlage sollen Empfehlungen f{\"u}r die Nachwuchsf{\"o}rderung entwickelt werden, um mehr geeignete Personen f{\"u}r Professuren in pflegebezogenen Studieng{\"a}ngen zu gewinnen. Vorhandene Daten teilnarrativer Interviews mit ProfessorInnen (n=11) und Masterstudierenden (n=11) sowie Promovierenden (n=10) pflegebezogener Studieng{\"a}nge wurden im Rahmen einer retrospektiven Datenanalyse mit dem dreistufigen Codierverfahren der Grounded Theory Methodologie ausgewertet. Die Ergebnisse zeigen, dass in der Pflegepraxis gewonnene Erfahrungen ausl{\"o}sende Momente wissenschaftlicher Karrieren sind. Diese l{\"o}sen den Drang aus, die dort herrschende Situation zu ver{\"a}ndern, wobei sich vier Karrieretypen unterscheiden lassen: Typ A forscht, weil er erlebt hat, dass es f{\"u}r pflegerische Ph{\"a}nomene keine geeigneten Pflegeinterventionen gab. Typ B lehrt, um dazu beizutragen, dass Pflegende zuk{\"u}nftig besser ausgebildet werden. Typ C ist als Pflegeperson von {\"A}rztInnen nicht ausreichend anerkannt worden und absolviert eine wissenschaftliche Qualifikation, um mit ihnen auf Augenh{\"o}he zu gelangen. Typ D wollte in der Praxis bleiben, ist aber bei Weiterentwicklungsprozessen blockiert worden und nimmt als Kompromiss eine Professur an. Identifizierte Kontextfaktoren sind u.a. mangelnde Wertsch{\"a}tzung f{\"u}r wissenschaftliches Handeln in der Pflege und das Fehlen von Stellen f{\"u}r hochschulisch qualifizierte Pflegepersonen in der Praxis. Angesichts der bestehenden Bedingungen k{\"o}nnen hochschulisch qualifizierte Pflegende in der Praxis nicht Fuß fassen. Als Konsequenz f{\"u}r die Pflegewissenschaft als Disziplin zeigt sich, dass in der Pflegepraxis Vorbilder fehlen, die zuk{\"u}nftige Generationen Pflegender dazu anregen k{\"o}nnten, selbst eine wissenschaftliche Karriere in der Pflege einzuschlagen. Dadurch besteht die Gefahr einer Verk{\"u}mmerung der Pflegewissenschaft. Auf Grundlage der Ergebnisse wird die durchg{\"a}ngige Implementierung geeigneter Stellen f{\"u}r hochschulisch qualifizierte Pflegepersonen in der Pflegepraxis als Ausgangsbasis wissenschaftlicher Nachwuchsf{\"o}rderung betrachtet. Als Konzept werden Hochschul-Praxis-Partnerschaften skizziert, die beginnend auf Bachelorniveau bis zur Post-doc-Phase Strukturen zu einem systematischen praxisbezogenen wissenschaftlichen Kompetenzauf- und -ausbau f{\"u}r akademisch qualifizierte Pflegende etablieren.}, language = {de} } @article{LinkHorstmannshoffMülleretal.2021, author = {Link, Friederike and Horstmannshoff, Caren and M{\"u}ller, Martin and L{\"u}ftl, Katharina}, title = {Wissenschaftliche Karriere bis zur Professur in pflegebezogenen Studiengängen - Ziel oder Kompromiss?}, series = {Lehren \& Lernen im Gesundheitswesen LLiG}, volume = {2021}, journal = {Lehren \& Lernen im Gesundheitswesen LLiG}, number = {6}, pages = {73 -- 85}, year = {2021}, abstract = {Die Pflegewissenschaft in Deutschland steht vor der Herausforderung, wissenschaftliche Strukturen und Karrierewege auszubilden. Erschwert wird dies durch einen Mangel an wissenschaftlichem Nachwuchs, der das Potential hat, pflegewissenschaftliche Professuren mit wissenschaftlicher Exzellenz und praktischer Erfahrung zu f{\"u}llen. Ziel dieses Beitrags ist es, darzustellen, was ausl{\"o}sende Momente f{\"u}r wissenschaftliche Karrieren sind, die in Professuren pflegebezogener Studieng{\"a}nge m{\"u}nden, und welche Kontextbedingungen diese Karrieren beeinflussen. Es soll auch aufgezeigt werden, wie wissenschaftliche Nachwuchskr{\"a}fte vorgehen, um ihre Ziele zu erreichen und welche Konsequenzen sich daraus f{\"u}r sie und f{\"u}r die Pflegewissenschaft ergeben. Auf dieser Grundlage sollen Empfehlungen f{\"u}r die Nachwuchsf{\"o}rderung entwickelt werden, um mehr geeignete Personen f{\"u}r Professuren in pflegebezogenen Studieng{\"a}ngen zu gewinnen. Vorhandene Daten teilnarrativer Interviews mit ProfessorInnen (n=11) und Masterstudierenden (n=11) sowie Promovierenden (n=10) pflegebezogener Studieng{\"a}nge wurden im Rahmen einer retrospektiven Datenanalyse mit dem dreistufigen Codierverfahren der Grounded Theory Methodologie ausgewertet. Die Ergebnisse zeigen, dass in der Pflegepraxis gewonnene Erfahrungen ausl{\"o}sende Momente wissenschaftlicher Karrieren sind. Diese l{\"o}sen den Drang aus, die dort herrschende Situation zu ver{\"a}ndern, wobei sich vier Karrieretypen unterscheiden lassen: Typ A forscht, weil er erlebt hat, dass es f{\"u}r pflegerische Ph{\"a}nomene keine geeigneten Pflegeinterventionen gab. Typ B lehrt, um dazu beizutragen, dass Pflegende zuk{\"u}nftig besser ausgebildet werden. Typ C ist als Pflegeperson von {\"A}rztInnen nicht ausreichend anerkannt worden und absolviert eine wissenschaftliche Qualifikation, um mit ihnen auf Augenh{\"o}he zu gelangen. Typ D wollte in der Praxis bleiben, ist aber bei Weiterentwicklungsprozessen blockiert worden und nimmt als Kompromiss eine Professur an. Identifizierte Kontextfaktoren sind u.a. mangelnde Wertsch{\"a}tzung f{\"u}r wissenschaftliches Handeln in der Pflege und das Fehlen von Stellen f{\"u}r hochschulisch qualifizierte Pflegepersonen in der Praxis. Angesichts der bestehenden Bedingungen k{\"o}nnen hochschulisch qualifizierte Pflegende in der Praxis nicht Fuß fassen. Als Konsequenz f{\"u}r die Pflegewissenschaft als Disziplin zeigt sich, dass in der Pflegepraxis Vorbilder fehlen, die zuk{\"u}nftige Generationen Pflegender dazu anregen k{\"o}nnten, selbst eine wissenschaftliche Karriere in der Pflege einzuschlagen. Dadurch besteht die Gefahr einer Verk{\"u}mmerung der Pflegewissenschaft. Auf Grundlage der Ergebnisse wird die durchg{\"a}ngige Implementierung geeigneter Stellen f{\"u}r hochschulisch qualifizierte Pflegepersonen in der Pflegepraxis als Ausgangsbasis wissenschaftlicher Nachwuchsf{\"o}rderung betrachtet. Als Konzept werden Hochschul-Praxis-Partnerschaften skizziert, die beginnend auf Bachelorniveau bis zur Post-doc-Phase Strukturen zu einem systematischen praxisbezogenen wissenschaftlichen Kompetenzauf- und -ausbau f{\"u}r akademisch qualifizierte Pflegende etablieren.}, language = {de} } @article{HodelStuckiProdinger2021, author = {Hodel, Jsabel and Stucki, Gerold and Prodinger, Birgit}, title = {The potential of prediction models of functioning remains to be fully exploited: A scoping review in the field of spinal cord injury rehabilitation}, series = {Journal of Clinical Epidemiology}, volume = {139}, journal = {Journal of Clinical Epidemiology}, pages = {177 -- 190}, year = {2021}, abstract = {Objective: The study aimed to explore existing prediction models of functioning in spinal cord injury (SCI). Study design and setting: The databases PubMed, EBSCOhost CINAHL Complete, and IEEE Xplore were searched for relevant literature. The search strategy included published search filters for prediction model and impact studies, index terms and keywords for SCI, and relevant outcome measures able to assess functioning as reflected in the International Classification of Functioning, Disability and Health (ICF). The search was completed in October 2020. Results: We identified seven prediction model studies reporting twelve prediction models of functioning. The identified prediction models were mainly envisioned to be used for rehabilitation planning, however, also other possible applications were stated. The method predominantly used was regression analysis and the investigated predictors covered mainly the ICF components of body functions and activities and participation, next to characteristics of the health condition and health interventions. Conclusion: Findings suggest that the development of prediction models of functioning for use in clinical practice remains to be fully exploited. By providing a comprehensive overview of what has been done, this review informs future research on prediction models of functioning in SCI and contributes to an efficient use of research evidence.}, language = {en} } @article{HodelEhrmannScheelSaileretal.2021, author = {Hodel, Jsabel and Ehrmann, Cristina and Scheel-Sailer, Anke and Stucki, Gerold and Bickenbach, Jerome E. and Prodinger, Birgit}, title = {Identification of Classes of Functioning Trajectories and Their Predictors in Individuals With Spinal Cord Injury Attending Initial Rehabilitation in Switzerland}, series = {Archives of Rehabilitation Research and Clinical Translation}, volume = {3}, journal = {Archives of Rehabilitation Research and Clinical Translation}, number = {2}, pages = {100121}, year = {2021}, abstract = {Objectives: To identify classes of functioning trajectories in individuals with spinal cord injury (SCI) undergoing initial rehabilitation after injury and to examine potential predictors of class membership to inform clinical planning of the rehabilitation process. Design: Longitudinal analysis of the individual's rehabilitation stay using data from the Inception Cohort of the Swiss Spinal Cord Injury Cohort Study (SwiSCI). Setting: Initial rehabilitation in specialized centers in Switzerland. Participants: Individuals with newly acquired SCI (N=748; mean age, 54.66±18.38y) who completed initial rehabilitation between May 2013 and September 2019. The cohort was primarily composed of men (67.51\%), persons with paraplegia (56.15\%), incomplete injuries (67.51\%), and traumatic etiologies (55.48\%). Interventions: Not applicable. Main Outcome Measures: Functioning was operationalized with the interval-based sum score of the Spinal Cord Independence Measure version III (SCIM III). For each individual, the SCIM III sum score was assessed at up to 4 time points during rehabilitation stay. The corresponding time of assessment was recorded by the difference in days between the SCIM III assessment and admission to the rehabilitation program. Results: Latent process mixed model analysis revealed 4 classes of functioning trajectories within the present sample. Class-specific predicted mean functioning trajectories describe stable high functioning (n=307; 41.04\%), early functioning improvement (n=39; 5.21\%), moderate functioning improvement (n=287; 38.37\%), and slow functioning improvement (n=115; 15.37\%), respectively. Out of 12 tested factors, multinomial logistic regression showed that age, injury level, injury severity, and ventilator assistance were robust predictors that could distinguish between identified classes of functioning trajectories in the present sample. Conclusions: The current study establishes a foundation for future research on the course of functioning of individuals with SCI in initial rehabilitation by identifying classes of functioning trajectories. This supports the development of specifically tailored rehabilitation programs and prediction models, which can be integrated into clinical rehabilitation planning.}, language = {en} } @article{HempelVelosodeOliveiraGaumannetal.2021, author = {Hempel, Louisa and Veloso de Oliveira, Julia and Gaumann, Andreas and Milani, Valeria and Schweneker, Katrin and Schenck, Kristina and Fleischmann, Bastian and Philipp, Patrick and Mederle, Stefanie and Garg, Arun and Piehler, Armin and Gandorfer, Beate and Schick, Cordula and Kleespies, Axel and Sellmann, Ludger and Bartels, Marius and Goetze, Thorsten O. and Stein, Alexander and Goekkurt, Eray and Pfitzner, Lucia and Robert, Sebastian and Hempel, Dirk}, title = {Landscape of Biomarkers and Actionable Gene Alterations in Adenocarcinoma of GEJ and Stomach - A Real World Data Analysis}, series = {Cancers}, volume = {13}, journal = {Cancers}, number = {17}, pages = {4453}, year = {2021}, abstract = {After several years of negative phase III trials in gastric and esophageal cancer, a significant breakthrough in the treatment of metastatic adenocarcinomas of the gastroesophageal junction (GEJ) and stomach (GC) is now becoming evident with the emerging of precision oncology and implementation of molecular targets in tumor treatment. In addition, new generation studies such as umbrella and basket trials are focused on these molecular targets, which makes an early molecular diagnosis based on IHC/ISH and NGS necessary. The required companion diagnostics of Her2neu overamplification or PD-L1 expression is based on immunohistochemistry (IHC) or additionally in situ hybridization (ISH) in case of an IHC Her2neu score of 2+. However, there are investigator-dependent differences in the assessment of Her2neu amplification and different PD-L1 scoring systems obtained by IHC/ISH. The use of high-throughput technologies such as next-generation sequencing (NGS) holds the potential to standardize the analysis and thus make them more comparable. In the presented study, real-world multigene sequencing data of 72 Caucasian patients diagnosed with metastatic adenocarcinomas of GEJ and stomach were analyzed. In the clinical companion diagnostics, we found ESCAT level I molecular targets in one-third of our patients, which directly determined the therapy. In addition, we found potential targets in 14/72 patients (19.4\%) who potentially qualify for precision therapies in corresponding molecular studies. The study highlights the importance of comprehensive molecular profiling for precision treatment of GEJ/GC and indicates that a biomarker evaluation should be performed for all patients with metastatic adenocarcinomas before the initiation of first-line treatment and during second-line or subsequent treatment.}, language = {en} }