Background/Objectives: Cow's milk allergy (CMA) presents a significant clinical burden. The Cow's Milk-related Symptom Score (CoMiSS™) is a widely used clinical screening tool designed to raise awareness of CMA among healthcare professionals. This qualitative study aimed to assess the need for a parent-reported CoMiSS™ tool (Pre-CoMiSS™) and explore its potential usefulness for parents and primary care physicians (PCPs). Methods: Participants were parents of infants aged 2-12 months and PCPs from Germany, Sweden, Spain, and the United Kingdom (UK) selected from a local panel of potential respondents. Interviews, conducted by experienced qualitative research moderators, consisted of pre-decided standardised questions. Thematic analysis was undertaken, and themes were derived from the data. Results: A total of 26 parent interviews and 18 primary care physician interviews were conducted. Parents from all countries found the Pre-CoMiSS™ tool helpful for understanding their baby's signs, easy to use, and useful for facilitating consultation with the physician. Physicians in the UK, Spain, and Sweden found that the Pre-CoMiSS™ tool was helpful for improving symptom reporting and for medical consultations; however, in Germany, physicians had mixed opinions, expressing concerns that the tool might increase parental anxiety, lead to overdiagnosis of CMA, and add to their workload. Conclusions: A parent-specific tool for recording cow's milk-related symptoms was generally well received by parents and most physicians, though concerns about parental anxiety and workload were noted, particularly in Germany. With further validation and refinement, Pre-CoMiSS™ may be a useful tool for parents to record their infant's symptoms related to feeding and support PCPs in considering CMA in these infants.

Children's Hospital Helsinki University Hospital University of Helsinki 00014 Helsinki Finland

Clinique Marcel Sembat Ramsay Group 92100 Paris France

Department of Medicine and Technological Innovation Pediatric Unit University of Insubria 21100 Varese Italy

Department of Paediatrics Medical University of Warsaw 02 091 Warsaw Poland

Department of Pediatrics Gastroenterology and Nutrition Collegium Medicum University of Warmia and Mazury 10719 Olsztyn Poland

Department of Pediatrics University Hospital Brno Faculty of Medicine Masaryk University 62500 Brno Czech Republic

Department of Translational Medical Sciences University of Naples Federico 2 80138 Naples Italy

Faculty of Medicine KU Leuven Belgium 3000 Leuven Belgium

Hassenfeld Children's Hospital Department of Pediatrics NYU Grossman School of Medicine New York NY 10016 USA

Institute of Gastroenterology Nutrition and Liver Diseases Schneider Children's Medical Center of Israel Petah Tikva 4920235 Israel

Ipsos SA 1219 Geneva Switzerland

KidZ Health Castle UZ Brussel Vrije Universiteit Brussel 1090 Brussels Belgium

Nestlé Health Science 1800 Vevey Switzerland

Pediatric Gastroenterology Unit La Fe Hospital Research Institute 46026 Valencia Spain

School of Medicine Faculty of Medical and Health Sciences Tel Aviv University Tel Aviv 6997801 Israel

Section of Allergy and Clinical Immunology Children's Hospital Colorado University of Colorado Aurora CO 80045 USA

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