Methodological Challenges in Randomized Controlled Trials of mHealth Interventions: Cross-Sectional Survey Study and Consensus-Based Recommendations

Jesus Lopez-Alcalde   ^{1, 2, 3} , MPH, MD ;   L Susan Wieland   ^{1, 4} , MPH, PhD ;   Yuqian Yan   ¹ , PhD ;   Jürgen Barth   ¹ , PhD ;   Mohammad Reza Khami   ^{5, 6} , DDS, PhD ;   Siddharudha Shivalli   ⁷ , MD ;   Cynthia Lokker   ⁸ , MSc, PhD ;   Harleen Kaur Rai   ⁹ , PhD ;   Paul Macharia   ^{10, 11} , MSc, PhD ;   Sergi Yun   ^{12, 13, 14, 15} , MD ;   Elvira Lang   ¹⁶ , MD, PhD ;   Agnes Bwanika Naggirinya   ¹⁷ , MBChB, MSc, Mmed ;   Concepción Campos-Asensio   ¹⁸ , BPharm, MLiS ;   Leila Ahmadian   ¹⁹ , PhD ;   Claudia M Witt   ^{20, 21} , MBA, MD

¹ Institute for Complementary and Integrative Medicine, University Hospital Zurich, Zurich, Switzerland

² Faculty of Medicine, Universidad Francisco de Vitoria, Madrid, Spain

³ Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Unidad de Bioestadística Clínica, Hospital Universitario Ramón y Cajal, Center for Biomedical Research in Epidemiology and Public Health Network (CIBERESP), Madrid, Spain

⁴ School of Medicine and Health Sciences, George Washington University, Washington, DC, United States

⁵ Research Center for Caries Prevention, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran

⁶ Community Oral Health Department, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran

⁷ Department of Medical Statistics, Faculty of Epidemiology and Public Health, London School of Hygiene & Tropical Medicine, London, United Kingdom

⁸ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada

⁹ Digital Health and Wellness Research Group, Department of Computer and Information Sciences, University of Strathclyde, Glasgow, United Kingdom

¹⁰ Department of Research and Programmes, Kenyatta National Hospital, Nairobi, Kenya

¹¹ University of Nairobi, Faculty of Health Sciences, Nairobi, Kenya

¹² Bio-Heart Cardiovascular Diseases Research Group, Bellvitge Biomedical Research Institute, L'Hospitalet de Llobregat, Barcelona, Spain

¹³ Community Heart Failure Program, Cardiology Department, Bellvitge University Hospital, L’Hospitalet de Llobregat, Barcelona, Spain

¹⁴ Internal Medicine Department, Bellvitge University Hospital, Barcelona, Spain

¹⁵ Center for Biomedical Research in Cardiovascular Diseases (CIBERCV), Instituto Salud Carlos III, Madrid, Spain

¹⁶ Hypnalgesics, Comfort Talk, Brookline, MA, United States

¹⁷ Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda

¹⁸ Biblioteca Médica, Hospital Universitario de Móstoles, Móstoles, Spain

¹⁹ Fakher Mechatronic Research Center, Kerman University of Medical Sciences, Kerman, Iran

²⁰ Institute for Complementary and Integrative Medicine, University of Zurich, Zurich, Switzerland

²¹ Institute for Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, Berlin, Germany