Pain is ubiquitous, but effective pain relief eludes many. Research has shown that some pain behaviours are perceived as gendered, and this may influence the way men and women express and cope with pain, but such enquiries have not extended to specific methods of pain relief. Our aim was to explore perceptions of the most socially acceptable ways for men and women to relieve pain. Across two studies, sixty participants (50% male) aged 18-78 completed a Q-sort task, sorting different pain relief strategies by the social acceptability for either women (Study 1; N=30) or men (Study 2; N=30). Analyses revealed two stereotypes for each sex. The overarching stereotype for women suggested it is most acceptable for them to use pain relief strategies considered conventional and effective. However, a second stereotype suggested it is most acceptable for women to use strategies which generally conform to feminine gender norms and stereotypes. The overarching male stereotype suggested it is most acceptable for men to use pain relief aligned with stereotypical masculinity, however a second stereotype also emerged, characterised by conventional and effective responses to pain, much like the overarching stereotype for women. These differing viewpoints seem to depend on whether gender norm conformity or perceived analgesic efficacy is thought to determine social acceptability. These studies provide initial evidence of both a gendered and ungendered lens through which pain relief can be viewed, which may influence how men and women use pain relief.
Purpose
Endometriosis is a chronic disorder of the female reproductive system characterized by debilitating symptoms, particularly endometriosis-related pain (ERP). Patient-reported outcome (PRO) measures of symptoms and impacts are required to assess disease severity in ERP clinical studies and clinical practice. A content-valid instrument was developed by modifying the Dysmenorrhea Daily Diary (DysDD) to form the Endometriosis Daily Diary (EDD), an electronic PRO administered via handheld device.
Methods
Qualitative research with US females with ERP was conducted in three stages: (1) Development of an endometriosis conceptual model based on qualitative literature and conduct of concept elicitation (CE) interviews (N = 30). (2) Cognitive debriefing (CD) interviews (N = 30) conducted across two rounds to assess relevance and understanding of the EDD, with modifications between interview rounds. (3) Pilot testing to assess usability/feasibility of administrating the EDD daily on an electronic handheld device (N = 15). Clinical experts provided guidance throughout the study.
Results
The conceptual model provided a comprehensive summary of endometriosis to inform modifications to the DysDD, forming the EDD. CD results demonstrated that EDD items were relevant for most participants. Instructions, items, response scales, and recall period were well-understood. The resulting daily diary assesses severity of cyclic and non-cyclic pelvic pain, dyspareunia, impact of ERP on functioning and daily life, symptoms associated with ERP, and bowel symptoms. Participants were able to complete the diary daily and found the device easy to use.
Conclusion
The EDD demonstrated good content validity in females experiencing ERP. The next step is to perform psychometric validation in an ERP sample.
Introduction: Sjo ¨gren's Syndrome Symptom Diary (SSSD) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) are patient-reported outcome (PRO) instruments assessing Sjo ¨gren's symptoms. Original SSSD items have demonstrated content validity, however qualitative evidence supporting the updated 'tiredness' item and two new supplementary items is lacking. Although well established and validated in other rheumatic diseases, there is no qualitative evidence sup-porting content validity of FACIT-F in Sjo ¨gren's. This study addressed these evidence gaps to support use of SSSD and FACIT-F as clinical trial endpoints, in clinical practice and in other research settings. Methods: Qualitative, semi-structured telephone interviews were conducted with patients with Sjo ¨gren's (n = 12) and expert Sjo ¨gren's physicians (n = 10). Patient interviews explored content validity (e.g., understanding and relevance) of the new and updated SSSD items, perceptions of item and total score meaningful change on SSSD, and understanding and relevance of FACIT-F items. Physician interviews explored opinions on various SSSD scoring approaches. Results: The new and updated SSSD items and FACIT-F demonstrated good content validity. Most patients considered a two-point improvement on most SSSD items meaningful, as well as a one-or two-point total score improvement. Most physicians reported tracking changes in patient responses to individual items as the most appropriate SSSD scoring approach. Conclusions: SSSD and FACIT-F are content valid in a Sjo ¨gren's population, meeting an important criterion to support their use as
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