title: Qualitative development of a patient-reported outcome symptom measure in diarrhea-predominant irritable bowel syndrome.
abstract: OBJECTIVE
  Despite a documented clinical need, no patient reported outcome (PRO) symptom measure meeting current regulatory requirements for clinically relevant end points is available for the evaluation of treatment benefit in diarrhea-predominant IBS (IBS-D).
  
  
  METHODS
  Patients (N=113) with IBS-D participated in five study phases: (1) eight concept elicitation focus groups (N=34), from which a 17-item IBS-D Daily Symptom Diary and four-item IBS-D Symptom Event Log (Diary and Event Log) were developed; (2) one-on-one cognitive interviews (N=11) to assess the instrument's comprehensiveness, understandability, appropriateness, and readability; (3) four data triangulation focus groups (N=32) to confirm the concepts elicited; (4) two hybrid (concept elicitation and cognitive interview) focus groups (N=16); and (5) two iterative sets of one-on-one cognitive interviews (N=20) to further clarify the symptoms of IBS-D and debrief a revised seven-item Diary and four-item Event Log.
  
  
  RESULTS
  Of thirty-six concepts initially identified, 22 were excluded because they were not saturated, not clinically relevant, not critical symptoms of IBS-D, considered upper GI symptoms, or too broad or vaguely defined. The remaining concepts were diarrhea, immediate need (urgency), bloating/pressure, frequency of bowel movements, cramps, abdominal/stomach pain, gas, completely emptied bowels/incomplete evacuation, accidents, bubbling in intestines (bowel sounds), rectal burning, stool consistency, rectal spasm, and pain while wiping. The final instrument included a daily diary with separate items for abdominal and stomach pain and an event log with four items completed after each bowel movement as follows: (1) a record of the bowel movement/event and an assessment of (2) severity of immediacy of need/bowel urgency, (3) incomplete evacuation, and (4) stool consistency (evaluated using the newly developed Astellas Stool Form Scale). Based on rounds of interviews and clinical input, items considered secondary or nonspecific to IBS-D (rectal burning, bubbling in intestines, spasms, and pain while wiping) were excluded.
  
  
  CONCLUSIONS
  The IBS-D Symptom Diary and Event Log represent a rigorously developed PRO instrument for the measurement of the IBS-D symptom experience from the perspective of the patient. Its content validity has been supported, and future work should evaluate the instrument's psychometric properties.
authors: TwoLegs Consulting, Newton, Massachusetts, USA.
authors: P
authors: P
authors: Marquis
authors: Pharmerit International, Cambridge, Massachusetts, USA.
authors: K E
authors: KE
authors: Lasch
authors: Astellas Pharma Global Development, Northbrook, Illinois, USA.
authors: L
authors: L
authors: Delgado-Herrera
authors: Merck and Co., Whitehouse Station, New Jersey, USA.
authors: S
authors: S
authors: Kothari
authors: Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
authors: A
authors: A
authors: Lembo
authors: Astellas Pharma Global Development, Northbrook, Illinois, USA.
authors: C
authors: C
authors: Lademacher
authors: Astellas Pharma Global Development, Northbrook, Illinois, USA.
authors: G
authors: G
authors: Spears
authors: Astellas Pharma Global Development, Tokyo, Japan.
authors: A
authors: A
authors: Nishida
authors: Adelphi Values (Formerly Mapi Values), Boston, Massachusetts, USA.
authors: Waldman L
authors: WL
authors: Tesler
authors: Adelphi Values (Formerly Mapi Values), Boston, Massachusetts, USA.
authors: E
authors: E
authors: Piault
authors: University of North Carolina, Wilmington, North Carolina, USA.
authors: K
authors: K
authors: Rosa
authors: Astellas Pharma Global Development, Northbrook, Illinois, USA.
authors: B
authors: B
authors: Zeiher