PO-05 | Validation of the Italian version of the HARDSHIP Questionnaire in a school-based population

Agnese Onofri,¹ Chiara Rosignoli,¹ Vittorio Trozzi,¹ Martina D’Ambrosio,¹ Benedetta Germani,¹ Roberta Ciuffini,² Raffaele Ornello,¹ Simona Sacco¹ | ¹Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila; ²Department of Clinical Medicine, Public health, Life and Environmental Sciences, University of L’Aquila, Italy

Background: Headache disorders are highly prevalent in children and adolescents but frequently underdiagnosed due to diagnostic complexity and symptom underreporting. A notable gap persists in high-quality epidemiological data on pediatric headache in Italy. This study aims to validate the Italian version of the Child and Adolescents Headache-Attributed Restriction, Disability, Social Handicap and Impaired Participation (HARDSHIP) questionnaire, a standardized tool for assessing headache prevalence and burden, developed by the Global Campaign Against Headache.

Methods: The study was conducted within the REPICEF registry (Registro Epidemiologico delle Cefalee in Età Evolutiva), approved by the Ethics Committee of the Abruzzo Region (protocol 035018). Children and adolescents aged 6–17 years from selected schools in L’Aquila were enrolled between February and December 2024. The Italian version of the HARDSHIP questionnaire was developed via TRAPD methodology. Questionnaire-based diagnoses were compared against clinical assessments performed by headache specialists using ICHD-3 criteria. Diagnostic performance was evaluated through sensitivity, specificity, positive and negative predictive values (PPV-NPV), and Cohen’s kappa. Statistical analyses were performed using R (v.4.3.0).

Results: Of 1053 screened students, 858 were included in the cohort; the first 535 (62.4%) were selected for validation analyses. Based on the HARDSHIP questionnaire, the most common diagnoses were migraine in 68 (7.9%), Tension-Type Headache (TTH) in 86 (10.0%), probable Migraine (pMig) in 175 (20.7%), probable Tension-Type Headache (pTTH) in 144 (16.7%), and Undifferentiated Headache (UDH) in 105 (12.2%) children and adolescents. The agreement between questionnaire-based and clinical diagnoses was moderate for pMIG (κ = 0.432) and fair for pTTH (κ = 0.327). Specificity was high for both pMIG and pTTH, while sensitivity remained low.

Conclusion: The Italian HARDSHIP questionnaire demonstrates adequate specificity and moderate agreement with clinical diagnosis for pediatric migraine, supporting its use as an epidemiological screening tool. While clinical confirmation remains essential, this instrument facilitates population-level monitoring and may inform targeted interventions for headache disorders in youth.