Johann Frick|Pimrapat Gebert|Ulrike Grittner|Anne Letsch|Daniel Schindel|Liane Schenk
Identifying and handling unbalanced baseline characteristics in a non-randomized, controlled, multicenter social care nurse intervention study for patients in advanced stages of cancer
Berlin Institute of Health at Charité - Universitätsmedizin Berlin|Humboldt-Universität zu Berlin|Freie Universität Berlin|Berlin Institute of Health at Charité - Universitätsmedizin Berlin|Humboldt-Universität zu Berlin|Freie Universität Berlin|Charité - Universitätsmedizin Berlin|Humboldt-Universität zu Berlin|Freie Universität Berlin|University Hospital Schleswig-Holstein|University of Lübeck|Berlin Institute of Health at Charité - Universitätsmedizin Berlin|Humboldt-Universität zu Berlin|Freie Universität Berlin|Berlin Institute of Health at Charité - Universitätsmedizin Berlin|Humboldt-Universität zu Berlin|Freie Universität Berlin
abstract purpose given psychosocial burdens patients advanced stages cancer face innovative care concepts needed time vulnerable patient groups difficult reach participation intervention studies randomized patient inclusion may feasible article aims identify systematic biases respectively selection effects occurring recruitment phase discuss potential causes based nonrandomized multicenter intervention study patients advanced stages cancer methods patients diagnosed least one 16 predefined cancers recruited four hospitals three german cities effect social care nurses continuous involvement acute oncology wards measured healthrelated quality life eortc qlqc30 information participation preferences decisional conflicts doctorpatient communication health literacy symptom perception absolute standardized mean difference calculated standardized effect size test baseline characteristics balance intervention control groups results study enrolled 362 patients 150 intervention 212 control group except gender groups differed relevant sociodemographic characteristics eg regarding age educational background respect distribution diagnoses intervention group showed higher symptom burden control group moreover control group reported better quality life baseline compared intervention group 526 points sd 217 478 points sd 220 asmd 0218 p 0044 conclusion overall intervention group showed social health vulnerability control group among factors wide range diagnoses included structural variation recruiting clinics increased risk bias recommend close continuous monitoring relevant social healthrelated characteristics recruitment phase well use appropriate statistical analysis strategies adjustment propensity score methods trial registration german clinical trials register drksid drks00013640 registered 29th december 2017