Identifying Health Economic Considerations to Include in the Research Protocol of a Randomized Controlled Trial (the REDUCE-RISK Trial): Systematic Literature Review and Assessment

Mattias Neyt   ¹ , MSc, PhD ;   Annick Christiaens   ² , BNurs ;   Marina Aloi   ³ , MD, PhD ;   Lissy de Ridder   ⁴ , MD, PhD ;   Nicholas M Croft   ⁵ , MBBS, PhD ;   Sibylle Koletzko   ^{6, 7} , MD ;   Arie Levine   ⁸ , MD ;   Dan Turner   ⁹ , MD, PhD ;   Richard K Russell   ¹⁰ , MD, PhD ;   Frank M Ruemmele   ^{11, 12} , MD, PhD ;   Gigi Veereman   ¹³ , MD, PhD

¹ Medical Evaluation and Technology Assessment (ME-TA), Merendree, Belgium

² Pediatric Gastroenterology and Nutrition, University Hospital Brussels, Brussels, Belgium

³ Department of Maternal and Child Health, Gastroenterology Unit, Sapienza University of Rome, Rome, Italy

⁴ Erasmus MC Sophia Childrens’ Hospital Rotterdam, Rotterdam, Netherlands

⁵ Blizard Institute, Barts and the London School of Medicine, Queen Mary University of London, London, United Kingdom

⁶ Department of Pediatrics, Dr von Hauner Children's Hospital LMU Klinikum, University of Munich, Munich, Germany

⁷ Department of Pediatrics, Gastroenterology and Nutrition, School of Medicine Collegium Medicum University of Warmia and Mazury, Olsztyn, Poland

⁸ Pediatric Gastroenterology and Nutrition Unit, Wolfson Medical Center, Holon, Israel

⁹ Institute of Paediatric Gastroenterology, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel

¹⁰ Department of Paediatric Gastroenterology, The Royal Hospital for Sick Children, Edinburgh, United Kingdom

¹¹ Hôpital Necker Enfants Malades, Assistance Publique - Hôpitaux de Paris, Service de Gastroentérologie Pédiatrique, Paris, France

¹² Faculté de Médecine, Université de Paris, Paris, France

¹³ Pediatric Gastroenterology and Nutrition, Vrije Universiteit Brussel, University Hospital Brussels, Brussels, Belgium