Development of a new patient-reported outcome measure for complex cryptoglandular fistulas (20-Item complex cryptoglandular fistula questionnaire™): a qualitative study.

BACKGROUND: There are limited tools to measure the burden of disease and effectiveness of medical/surgical interventions in patients with cryptoglandular fistulas. The aim of this study was to explore concepts that are relevant and important to patients with complex cryptoglandular fistulas (CCF) and to develop a patient-centred, disease-specific, patient-reported outcome measure (PROM) to assess symptom burden and impacts of CCF. METHODS: A targeted literature review was conducted, followed by one-to-one telephone interviews with five colorectal surgeons (USA, n = 3; UK, n = 1; Spain, n = 1) and 20 US adult patients with CCF to inform the development of a conceptual model and a CCF-specific PROM. The targeted literature review informed the development of the preliminary conceptual model and identified a PROM in the literature that was used as a reference to generate the draft CCF-specific PROM. The colorectal surgeon interviews provided insights on the experience of patients with CCF to refine the conceptual model, formulate probing questions for use in patient interviews, and to develop the draft CCF-specific PROM. Patients' descriptions of their experiences with symptoms and the impacts on their lives and evaluation of the draft CCF-specific PROM in concept elicitation and cognitive interviews were used to develop the final conceptual model and final CCF-specific PROM. RESULTS: Ten symptoms (odour, pain during bowel movement, abscess, post-operative pain, discharge/drainage/leakage, anal/perianal pain, inflammation/swelling, skin irritation, bleeding and itchiness) and 11 impacts (discomfort, inability to exercise, embarrassment, difficulty sitting, worry about disease, adapted life to maintain hygiene, negatively impacted social life/isolation, inability to perform daily activities, reduced interest in sex, negatively impacted intimate relationships and negatively impacted mood) were reported as most salient by patients. The patient experience, clinician perspective, and literature review provided input to item generation. Evaluation of relevance and patient understanding through cognitive interviews with patients provided evidence for the content validity of the new patient-reported outcome measure: the 20-item Complex Cryptoglandular Fistula Questionnaire™ (CCFQ-20™). CONCLUSION: The CCFQ-20™ is a new clinician-guided, patient-validated, disease-specific patient-reported outcome measure that measures disease impact and quality of life in patients with CCF.

Between Scylla and Charybdis: risks of early therapeutic anticoagulation for venous thromboembolism after acute intracranial hemorrhage.

OBJECTIVE: To assess the risk of hematoma expansion in patients with acute intracranial hemorrhage (ICH) requiring therapeutic anticoagulation for the treatment of venous thromboembolism. METHODS: We retrospectively reviewed all patients at our institution between 2014 and 2019 who were therapeutically anticoagulated for venous thromboembolism within 4 weeks after ICH. We included subtypes of traumatic ICH and spontaneous intraparenchymal hemorrhage. Our main outcome was the incidence of hematoma expansion within 14 days from initiating therapeutic anticoagulation. Hematoma expansion was defined as (1) radiographically proven expansion leading to cessation of therapeutic anticoagulation or (2) death due to hematoma expansion. Secondary outcomes included mortality due to hematoma expansion and characteristics associated with hematoma expansion. RESULTS: Fifty patients met inclusion criteria (mean age: 54 years, 80% male, 76% Caucasian); 24% had undergone a neurosurgical procedure prior to therapeutic anticoagulation. Median time from ICH to therapeutic anticoagulation initiation was 9.5 days (IQR 4-17), 40% received therapeutic anticoagulation in <7 days after ICH. Six patients (12%) developed hematoma expansion, of whom two (4%) died. While not statistically significant, patients with hematoma expansion tended to be older (57.8 vs. 53.5 years), were anticoagulated sooner (4 vs. 10 days), presented with lower GCS (50% vs. 39% with GCS <8), higher hematoma volume (50% vs. 42% >30 cc), and higher SDH diameter (16 mm vs. 8.35 mm). There was a trend towards greater risk of hematoma expansion for patients undergoing endoscopic ICH evacuation (16% vs. 2%, p = 0.09); patients with hematoma expansion were more likely to present with hydrocephalus (67% vs. 16%, p = 0.02). CONCLUSIONS: Our study is among the first to explore characteristics associated with hematoma expansion in patients undergoing therapeutic anticoagulation after acute ICH. Larger studies in different ICH subtypes are needed to identify determinants of hematoma expansion in this high-acuity population.

Measuring the patient experience of chronic rhinosinusitis with nasal polyposis: qualitative development of a novel symptom diary.

BACKGROUND: This qualitative study assessed the experience of patients with chronic rhinosinusitis with nasal polyposis (NP) to inform the development of a novel symptom diary for clinical study use. METHODS: Concept elicitation and cognitive interviews were conducted with patients who had a physician-verified diagnosis of NP and a history of intranasal corticosteroid use. Concepts were identified via open-ended and follow-up questions. Relative symptom/impact disturbance level was assessed using a scale of 0 (not at all disturbing) to 10 (extremely disturbing). RESULTS: Patients (n = 30) attributed numerous symptoms and impacts to NP; the most prevalent and disturbing were nasal congestion (identified by 100% of patients; average disturbance rating = 7.9), nasal blockage/obstruction (97%; 8.2), difficulty with sense of smell (97%; 7.6), facial pressure (90%; 6.2), postnasal drip (87%; 6.5), runny nose (87%; 6.2), facial pain (80%; 6.3), and headache (77%; 6.5). These symptoms, along with the impact of NP on sleep and daily activities, were included in the Nasal Polyposis Symptom Diary (NPSD). Cognitive interviews confirmed that patients understood the NPSD items and could select a response reflective of their experience at its worst over the past 24 hours using a four-point scale (none, mild, moderate, or severe). CONCLUSION: The most relevant and disturbing symptoms, according to patients with NP, were included in the NPSD. Interviews confirmed the suitability of NPSD in capturing the daily experience of patients. These findings support the content validity of the NPSD as a suitable tool for capturing NP symptoms and impacts.