A Systematic Review of Outcome Measures and Concepts Included in Trials on Obesity in the Last Decade

 

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Abstract

Background: The prevalence of obesity is currently estimated at about 300 million people worldwide and is rising further on. Based on the current understanding of obesity as a complex, multifactorial condition, comprehensive outcomes are necessary for both the measurement of the burden of disease and the evaluation of treatment outcomes. An in-depth understanding of the outcome domains that have been used in studies of obesity in the last decade can bring us one step ahead in the definition of a set of domains that define “what should be measured” to comprehensively describe the burden of obesity and/or the evaluation of treatment outcomes.

Objective: The objective of this systematic review was to examine the use of the obesity-specific, generic and dimension-specific health status measures and concepts contained in these measures using the ICF as a reference tool in randomised controlled obesity trials (RCTs) from 1992-2001.

Methods: Randomized controlled trials between 1992 and 2001 were located in MEDLINE and selected according to predefined criteria. The outcome measures were extracted and the concepts contained in the outcome measures were linked to the ICF.

Results: A total of 428 trials were included in the study. Fifty-seven different health-status questionnaires were extracted. Of 16 034 extracted concepts 81% could be linked to the ICF. The most used ICF categories within the components body functions, activities and participation, environmental factors, and body structures, were general metabolic functions (b540), looking after one's health (d570), products or substances for personal consumption (e110), and structure of the trunk (s760) with frequencies of 65%, 57%, 16% and 13%, respectively.

Conclusion: The ICF provides a useful reference to identify and quantify the concepts contained in outcome assessment used in clinical obesity trials. There seems to be a lack of health concepts evaluating specific aspects of the environment and a need to systematically include patient oriented measures in randomized control trials.

Zusammenfassung

Hintergrund: Die Prävalenz von Adipositas wird derzeitig, mit steigender Tendenz, auf circa 300 Millionen Menschen weltweit geschätzt. Nach dem gegenwärtigen wissenschaftlichen Kenntnisstand wird Adipositas als eine komplexe multifaktorielle Erkrankung verstanden. Aus diesem Grund ist es in Adipositasstudien erforderlich, umfassende und weit reichende Messparametern und Studienendpunkten zu verwenden, um einerseits die Krankheitslast in ihrem gesamten Umfang zu erfassen und andererseits die Behandlungsergebnisse besser beurteilen zu können.

Eine genaue Untersuchung von Adipositasstudien der letzten zehn Jahre kann bei der Definition einer Vorgabe mithelfen, welche Messparameter grundsätzlich in Adipositasstudien verwendet werden sollten. Diese Vorgabe muss die für Adipositaspatieten spezifische Krankheitslast umfassend beschreiben. Durch die universelle Verwendung dieser Vorgabe kann in Zukunft das Auswerten und Vergleichen der Behandlungsergebnisse von Adipositasstudien vereinfacht werden.

Seitdem die Internationale Klassifikation der Funktionsfähigkeit, Behinderung und Gesundheit (ICF) von der Weltgesundheitsorganisation im Mai 2001 als einheitliche Sprache eingeführt wurde, ist es möglich Konzepte die in Messergebnissen beinhaltet sind zu identifizieren und zu vergleichen.

Ziel: Ziel dieser Arbeit ist die systematische Identifizierung von Konzepten die in Messparametern klinischer Adipositasstudien der Jahre 1992-2001 enthalten sind. Des Weiteren wird in dieser Arbeit die Verwendung von adipositas-spezifischen, generischen und dimensionsspezifischen Health-Status Fragebögen untersucht.

Methoden: Ein systematischer Literaturreview wurde durchgeführt, um randomisierte kontrollierte Studien (RCTs) mit Adipositaspatienten zu lokalisieren und zu selektieren. Alle Verfahren zur Outcome-Erfassung in den ausgewählten RCTs wurden identifiziert. Die Inhalte dieser Messverfahren wurden anschließend unterscucht, indem sie mit Hilfe der sogenannten Linking Methode zur ICF in Verbindung gesetzt wurden.

Ergebnisse: Insgesamt wurden 428 Studien mit Adipositaspatienten in dem Literaturreview eingeschlossen. Es wurden 57 verschiedene Health-Status Fragebögen in den ausgewerteten Pulikationen verwendet. Aus den 428 Studien wurden 16 034 Konzepte identifiziert, davon konnten 81% dem Kategoriensystem der ICF zugeordnet werden. Die am häufigsten verwendeten ICF-Kategorien, aufgeteilt nach deren ICF-Klassifikationskomponente Körperfunktionen, Aktivität und Partizipation, Umweltfaktoren und Körperstrukturen, waren ‘Allgemeine Stoffwechselfunktionen’ (b540), ‘Sorge um die eigene Gesundheit’ (d570), ‘Produkte oder Substanzen für den persönlichen Konsum’ (e110) und ‘Struktur des Rumpfes’ (s760) mit jeweils die folgenden Häufigkeiten: 65%, 57%, 16% und 13%.

Schussfolgerung: Diese Studie zeigt, dass die ICF ein nützliches Referenzsystem zur Identifizierung und Quantifizierung von Konzepten aus Verfahren zur Erfassung der Studienendpunkte in Adipositasstudien ist. Es scheint ein Mangel an ICF-Kategorien der ICF-Kalssifikationskomponente Adipositaspatienten stark relevanten ICF-Klassifikationskomponente Aktivität und Partizipation, verstärkt in Adipositasstudien einzuschließen.

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Correspondence

Prof. Dr. G. Stucki

Department of Physical Medicine and Rehabilitation

University of Munich

81377 Munich

Germany

Phone: +49/89/70 95 40 50

Fax: +49/89/70 95 88 36

Email: gerold.stucki@med.uni-muenchen.de