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Dissertation Stefan Heinmüller FINAL TECHNISCHE UNIVERSITÄT MÜNCHEN Institut für Allgemeinmedizin (Direktor: Univ.-Prof. Dr. Antonius Schneider) Inhalte, Qualität und Ergebnisse von randomisierten kontrollierten Studien der universitären Allgemeinmedizin in Deutschland – ein systematischer Review von 2000 bis 2014 Stefan Philipp Heinmüller Vollständiger Abdruck der von der Fakultät für Medizin der Technischen Universität München zur Erlangung des akademischen Grades eines Doktors der Medizin genehmigten Dissertation. Vorsitzender: Univ.-Prof. Dr. Jürgen Schlegel Prüfer der Dissertation: 1. apl. Prof. Dr. Klaus Linde 2. Univ.-Prof. Dr. Antonius Schneider Die Dissertation wurde am 08.02.2017 bei der Technischen Universität München eingereicht und durch die Fakultät für Medizin am 21.02.2018 angenommen. Meinen Großeltern Erika und Dr. Werner Heinmüller aus Mansbach Inhaltsverzeichnis 1 Einleitung und Zielsetzung ........................................................................................ 1 1.1 Bedeutung der Hausarztmedizin ....................................................................... 1 1.2 Notwendigkeit der Forschung in der Allgemeinmedizin sowie deren universitärer Anbindung ..................................................................................... 2 1.3 Historische Entwicklung der akademischen Allgemeinmedizin in Deutschland ......................................................................................................... 3 1.4 Herausforderungen der universitären Allgemeinmedizin ............................... 5 2 Methodik ..................................................................................................................... 9 2.1 Protokoll und Regelwerk .................................................................................... 9 2.2 Einschlusskriterien ............................................................................................. 9 2.2.1 Publikationszeitraum ......................................................................................... 9 2.2.2 Studiendesign ................................................................................................... 9 2.2.3 Affiliation zur deutschen universitären Allgemeinmedizin ............................... 10 2.3 Literatursuche ................................................................................................... 10 2.3.1 2000 bis 2010: Publikationen aus Vorgängerdissertation ............................... 11 2.3.2 2010 bis 2014: Datenbanksuche Scopus und Durchsicht von Publikationslisten ............................................................................................ 12 2.3.3 Durchsicht von Literaturangaben (engl. reference tracking) ........................... 14 2.4 Selektionsprozess ............................................................................................. 15 2.4.1 2000 bis 2010: Selektion der Publikationen aus Vorgängerdissertation ........ 15 2.4.2 2010 bis 2014: Selektion der Publikationen aus Datenbanksuche Scopus und Durchsicht von Publikationslisten ............................................................ 16 2.5 Extraktion von Studieninformationen ............................................................. 17 2.5.1 Extraktionsprozess – praktisches Vorgehen ................................................... 17 2.5.2 Formale Merkmale und Finanzierung .............................................................. 20 2.5.3 Thematische Einordnung ................................................................................ 21 2.5.4 Studienbeteiligte und Studienteilnehmer ........................................................ 21 2.5.5 Details zum Studiendesign ............................................................................. 23 2.5.6 Ergebnisse der untersuchten Studien ............................................................. 24 I 2.6 Beurteilung von Verzerrungsrisiken ................................................................ 24 2.6.1 „Random sequence generation“ ..................................................................... 25 2.6.2 „Allocation concealment“ ................................................................................ 26 2.6.3 „Blinding of participants and personnel“ ........................................................ 28 2.6.4 „Blinding of outcome assessment“ ................................................................. 30 2.6.5 „Incomplete outcome data“ ............................................................................ 31 2.6.6 „Selective reporting“ ....................................................................................... 33 2.7 Zusammenfassung und Beurteilung von Studienergebnissen ..................... 33 2.7.1 „Vote count“ .................................................................................................... 33 2.7.2 Metaanalyse .................................................................................................... 35 3 Ergebnisse ................................................................................................................ 37 3.1 Literatursuche und Selektionsprozess ........................................................... 37 3.1.1 Publikationen aus Vorgängerdissertation, Scopussuche, „reference tracking“ .......................................................................................................... 37 3.1.2 Publikationslisten ............................................................................................ 37 3.1.3 Selektionsprozess ........................................................................................... 38 3.1.4 Nachträglicher Studienausschluss .................................................................. 39 3.2 Merkmale der eingeschlossenen Studien ...................................................... 42 3.2.1 Zeitpunkt der Veröffentlichung, Publikationssprache und Autorenschaft ...... 42 3.2.2 Beteiligte Abteilungen ..................................................................................... 45 3.2.3 Finanzierung .................................................................................................... 46 3.2.4 Untersuchte Fragestellungen .......................................................................... 48 3.2.5 Informationen zum Studiendesign .................................................................. 57 3.2.6 Orte der Studiendurchführung ........................................................................ 63 3.2.7 Beteiligte und Teilnehmer der untersuchten Studien ...................................... 64 3.3 Verzerrungsrisiken der untersuchten Studien ............................................... 69 3.3.1 Verzerrungsrisiken der clusterrandomisierten Studien ................................... 69 3.3.2 Verzerrungsrisiken der „klassischen“ randomisierten Studien ....................... 70 3.4 Zusammenfassung und Beurteilung der Studienergebnisse ....................... 73 3.4.1 „Vote count“ .................................................................................................... 73 3.4.2 Metaanalyse .................................................................................................... 75 II 4 Diskussion ................................................................................................................ 77 4.1 Zusammenfassung der Hauptergebnisse ...................................................... 77 4.2 Methodenkritik .................................................................................................. 78 4.2.1 Literatursuche ................................................................................................. 78 4.2.2 Erste Arbeit dieser Art – Stärke oder Schwäche? ........................................... 78 4.2.3 Einschlusskriterien .......................................................................................... 79 4.2.4 Hürden und Kritikpunkte der Studienanalyse ................................................. 80 4.3 Interpretation ..................................................................................................... 82 4.3.1 RCTs der deutschen universitären Allgemeinmedizin – Entwicklung und Vergleich ......................................................................................................... 82 4.3.2 Clusterrandomisierte Studien der universitären Allgemeinmedizinforschung 84 4.3.3 Inhaltliche Einordnung der analysierten Studien ............................................. 86 4.3.4 Methodik der analysierten Studien ................................................................. 87 4.3.5 Effekte der untersuchten Interventionen ......................................................... 89 4.4 Schlussfolgerung .............................................................................................. 89 5 Zusammenfassung ................................................................................................... 91 Abbildungsverzeichnis ....................................................................................................... i Tabellenverzeichnis .......................................................................................................... iii Abkürzungsverzeichnis ..................................................................................................... v Literaturverzeichnis ......................................................................................................... xi Verzeichnis aller Text- und Studienreferenzen ...............................................................
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