Validation of a questionnaire evaluating risk of hypersensitivity towards titanium and its oxide

A questionnaire to identify patients with suspected hypersensitivity to titanium and titanium oxide has been developed. The questionnaire was validated using Spearman's correlation and Cronbach's alpha coefficient. A sublingual test (ST) with titanium oxide was used (122 people) as an objective indicator of the titanium and titanium oxide allergy presence. Major and minor criteria were identified, as well as risk factors for the presence of hypersensitivity to titanium and titanium oxide, with point scores assigned to each question. The reliability and internal consistency of the questionnaire was 0.83. The risks of allergy to titanium and titanium oxide and the need for subsequent objective testing based on the accumulated points were determined: less than 3 – low risk, further testing at the request of the patient; 3–5 – moderate risk, testing is recommended; 3 or more, with major criteria present, or more than 5 without major criteria – high risk – patient testing is necessary. The total score in patients with clinical suspicion to titanium and titanium oxide hypersensitivity determined by a doctor, as well as with a positive ST result, was significantly higher than in patients without suspicion of hypersensitivity (p<0.0001) and with a negative ST result (p=0.00005). Taking the scored points into account, the sensitivity of the developed questionnaire was 62%, specificity – 82%. The developed questionnaire is a reliable tool for anamnestic examination and can be used by doctors of various specialties to identify individuals with risk and need for further objective diagnosis of titanium and titanium oxide allergy.