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Background  A previous qualitative assessment of the psychosocial consequences of labelling hypertension describes the diagnosis of hypertension as a labelling event with potential unintended negative long-term psychosocial consequences (labelling effects). Until now, the benefits of diagnosing hypertension have been far more reported than the harms. To obtain the net result of the preventive interventions for cardiovascular disease, such as diagnosing and treating mild hypertension, assessing benefits and harms in the most comprehensive way possible is necessary, including the psychosocial consequences of labelling. When measuring psychosocial consequences of labelling hypertension, a questionnaire with high content validity and adequate psychometric properties is needed.    Objectives  The aim of this study was to describe the psychometric parameters of face and content-validated pool of items. Other objectives were also to screen the item pool by using Rasch model analysis and confirmatory factor analysis (CFA) for identifying such items with sufficient fit to the hypothesised models.    Methods  We surveyed the pool of items as a draft questionnaire to Brazilians recruited via social networks, sending e-mails, WhatsApp® messages and posting on Facebook®. The inclusion criteria were to be older than 18 years old, to be healthy and to have only hypertension.  We used Rasch model analysis to screen the item pool, discarding items that did not fit the hypothesised domain. We searched for local dependence and differential item functioning. We used CFA to confirm the derived measurement models and complementarily assessed reliability using Cronbach’s coefficient alpha.    Results  The validation sample consisted of 798 respondents. All 798 respondents completed Part I, whereas 285 (35.7%)—those with hypertension—completed Part II. A condition-specific questionnaire with high content validity and adequate psychometric properties was developed for people labelled with hypertension. This measure is called ‘Consequences of Labelling Hypertension Questionnaire’ and covers the psychosocial consequences of labelling hypertension in two parts, encompassing a total of 71 items in 15 subscales and 11 single items.    Conclusion  We developed a tool that can be used in future research involving hypertension, especially in scenarios of screening, prevention, population strategies and in intervention studies. Future use and testing of the questionnaire may still be required.    Supplementary Information  The online version contains supplementary material available at 10.1186/s41687-021-00291-4.

Psychometric properties of a condition-specific PROM for the psychosocial consequences of Labelling hypertension by using Rasch analysis