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Purpose To explore symptoms and disease impacts of Crohn’s disease and to develop a new patient-reported outcomes (PRO) measure according to industry best practices. Methods A conceptual model of relevant symptoms experienced by patients with Crohn’s disease was developed following a literature review. Three rounds of combined qualitative semi-structured concept elicitation and cognitive debriefing interviews with 36 patients (≥ 16 years) with Crohn’s disease and 4 clinicians were conducted to further explore the most commonly reported and most bothersome symptoms to patients. Interview results were used to update the conceptual model as well as items and response options included in The Crohn’s Disease Diary, a new PRO measure. Results All patients (N = 36) reported abdominal pain, loose or liquid bowel movements, and high or increased frequency of bowel movements, with most reporting these symptoms spontaneously (100%, 92%, and 75%, respectively). All patients reported bowel movement urgency, but 61% reported this symptom only when probed. Most also reported that symptoms impacted activities of daily living, work/school, and emotional, social, and physical functioning (overall, 78%–100%; spontaneously, 79% – 92%). Data regarding core symptoms of Crohn’s disease from clinician concept elicitation interviews supported patient data. The 17-item Crohn’s Disease Diary assesses core symptoms and impacts of Crohn’s disease over 24 h, and extraintestinal manifestations over 7 days. The content validity of the diary was confirmed during cognitive debriefing interviews. Conclusion The Crohn’s Disease Diary is a new PRO measure for the assessment of Crohn’s disease symptoms and impacts, developed according to industry best practices.

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The point we wish to emphasize here is the relationship between 1) delay in developing speech (i.e., “motor speech delay”), 2) delay in developing clear, mature, well articulated speech (i.e., persistent “infantilisms” of speech), 3) stuttering and 4) specific reading disability. Our clinical experience has taught us that the late talker and/or the one who persists in baby talk, is apt, himself, to have a reading disability or even to be a stutterer. If he himself happens to have neither of these complications, family histories usually show the occurrence of one or all of these disabilities within the wide family group as well as in the siblings of the patient. It is the repeated recurrence of these several language disability syndromes within the same family group that indicates the existence of a genetic relationship

A sample school population of 75 family units of equal size was investigated for expression of specific reading disability. 25.3% of the total children showed specific reading disability as defined in this study. By using spelling achievement as the criterion for the presence of the disability, the incidence of the disorder was shown to be much higher in certain families than in others, with clear sibling aggregation. The siblings of specific-reading-disability cases demonstrated lower spelling competence than the total siblings in normal families, even when well above a crippling level. Both within individual families and by grades, the spelling rating in relation to grade norms of the specific-reading-disability family cases with their siblings tended to decline with age, in contrast to normal families where it tended to improve with age. This pattern was even more striking if the greater language competence of females, now quite generally accepted and further supported by this study, was taken into account. It was demonstrated that the above patterns were not primarily a product of intelligence level or teaching methods. The bearing of these findings on the tenability of the most common, current hypotheses concerning causation was briefly discussed.