Treatment options for hemorrhoidal disease (HD) include conservative treatment (e.g. laxatives), rubber band ligation, and more invasive surgical treatment options. Outcomes reported in clinical trials evaluating treatment effectiveness are heterogeneous, making comparisons difficult. Moreover, clinical outcomes, such as recurrence, complications and symptoms, do not fully represent the relevant benefits and harms of treatment to the patient. We therefore developed (i) a core outcome set (COS) for HD treatment, and (ii) a patient-reported outcome measure (PROM) evaluating symptoms and impact on daily life.

Literature review established outcomes most commonly used in studies evaluating HD treatment. A Delphi study with health professionals and patients was conducted to rank and discuss the outcomes in terms of importance and completeness, and reach consensus on a COS. In addition, individual patient interviews (n=15) were held to gain insight into patient experiences with HD and treatment. A panel of experts subsequently developed a PROM that focused on the core outcomes. Face and content validity were assessed (n=10) using a retrospective verbal probing technique.

Recurrent symptoms, complications and treatment satisfaction were the primary focus for health professionals, while patients were more concerned with overall impact on daily life. Patients ranked blood loss, pain and itching as the most bothersome symptoms. A PROM was developed, consisting of seven items covering three domains: severity of symptoms, impact on daily life, and treatment satisfaction (if applicable). The questions and response options were clear to patients and content validity was good. The questionnaire took approximately three minutes to complete.

We developed a COS and a PROM for HD treatment. The PROM can be used in clinical trials as the primary outcome measure evaluating treatment effectiveness from the patient's perspective. It can also support shared decision-making regarding individual treatment pathways in clinical practice. A psychometric validation study is currently underway.