Development and validation of the Patient-Physician Relationship Scale among patients with irritable bowel syndrome.

BACKGROUND: An effective patient-physician relationship (PPR) is essential to the care of patients with irritable bowel syndrome (IBS). We sought to develop and validate an IBS-specific instrument to measure expectations of the PPR. METHODS: We conducted structured focus groups about PPRs with 12 patients with IBS. Qualitative analysis was used to generate a questionnaire (the Patient-Physician Relationship Scale [PPRS]), which was modified with input from content experts and usability testing. For validation, we administered it online to US adults with IBS. Participants also completed the Functional Bowel Disorder Severity Index, the Rome III Adult Functional gastrointestinal (GI) Disorder Criteria Questionnaire, and modified versions of the Communication Assessment Tool (CAT-15) and Patient-Doctor Relationship Questionnaire (PDRQ-9). We performed principal components factor analysis for the PPRS. KEY RESULTS: The PPRS contained 32 questions with responses on a 7-item Likert scale. Themes included interpersonal features, clinical care expectations, and aspects of communication. One thousand and fifty-four eligible individuals completed the survey (88% completion rate). Most participants were middle aged (mean 48 years, SD 16.3), white (90%), and female (86%). Factor analysis showed only one relevant factor, relating to quality of PPR. The final scale ranged from possible-96 to +96 (mean 62.0, SD 37.6). It correlated moderately with the CAT-15 (r=.40, P<.001) and PDRQ-9 (r=.30, P<.001), establishing concurrent validity. CONCLUSIONS & INFERENCES: We describe the development and validation of the first questionnaire for use in measuring patient expectations of the PPR, which can be used for future outcomes studies and training physicians.

Severity in irritable bowel syndrome: a Rome Foundation Working Team report.

OBJECTIVES: The concept of severity in irritable bowel syndrome (IBS) is clinically recognized and operative in diagnostic decision making and treatment planning. Yet, there is no consensus on its definition, and there are limited data on the prevalence of severity subgroups, its medical and psychosocial determinants, and its association with other health status measures. The aims of the Rome Foundation Working Team Committee were to summarize current research, to develop a consensus of understanding on this concept, and to make recommendations for its use in research and clinical care. METHODS: In 2006, a multinational committee of clinical investigators with expertise in IBS and/or psychometric research methods undertook a systematic review of the literature relating to severity in IBS. Owing to limited data, the Foundation commissioned three clinical studies to better characterize the concept of severity in IBS, and summary information and recommendations for future research and clinical care were developed. RESULTS: The main findings were: (i) severity in IBS is defined as a biopsychosocial composite of patient-reported gastrointestinal and extraintestinal symptoms, degree of disability, and illness-related perceptions and behaviors; (ii) both visceral and central nervous system physiological factors affect severity; as severity increases, the central nervous system provides a greater contribution; (iii) severity is related to and influences health-related quality of life and health behaviors and also guides diagnostic and therapeutic clinical decision making; (iv) severity can be subcategorized into clinically meaningful subgroups as mild (∼40%), moderate (∼35%), and severe (∼25%), and this provides a working model for use in future research and clinical care. CONCLUSIONS: Future work is required to understand more precisely the factors contributing to severity and to develop a valid patient-reported instrument to measure severity in IBS.

Gastroparesis and functional dyspepsia: excerpts from the AGA/ANMS meeting.

BACKGROUND: Despite the relatively high prevalence of gastroparesis and functional dyspepsia, the aetiology and pathophysiology of these disorders remain incompletely understood. Similarly, the diagnostic and treatment options for these two disorders are relatively limited despite recent advances in our understanding of both disorders. PURPOSE: This manuscript reviews the advances in the understanding of the epidemiology, pathophysiology, diagnosis, and treatment of gastroparesis and functional dyspepsia as discussed at a recent conference sponsored by the American Gastroenterological Association (AGA) and the American Neurogastroenterology and Motility Society (ANMS). Particular focus is placed on discussing unmet needs and areas for future research.

Development and content validity of a gastroparesis cardinal symptom index daily diary.

BACKGROUND: The Gastroparesis Cardinal Symptom Index (GCSI) is a patient-reported outcome for gastroparesis using a two-week recall period. To minimize potential patient recall effects, a daily diary version of the GCSI (GCSI-DD) was developed. AIMS: To evaluate the content validity of GCSI-DD for the symptoms in patients with documented gastroparesis, to capture symptom variability over time and to compare responses of this GCSI-DD to the original GCSI. METHODS: In gastroparesis adults with delayed gastric emptying, cognitive debriefing interviews were conducted to elicit their perspective on relevant symptoms of gastroparesis and relevant recall periods and to evaluate patient understanding of GCSI-DD. Patients completed the GCSI-DD daily over a 2-week period and completed the GCSI at baseline and the 2-week follow-up visit. RESULTS: Twelve gastroparesis patients, of whom five were diabetic and nine women, reported nausea (100%), vomiting (100%), stomach fullness (75%), bloating (58%) and loss of appetite (50%) were important symptoms. All patients understood diary instructions and item content and reported that the diary captured their gastroparesis symptom experience; 83% considered response scales adequate. There was significant daily variability in GCSI-DD scores. Mean GCSI-DD subscale and total scores over 2 weeks correlated strongly (all r > 0.90) with GCSI scores at 2-week follow-up. CONCLUSIONS: The GCSI-DD includes symptoms relevant to patients with gastroparesis, captures daily variability of those symptoms and has psychometric properties consistent with a good patient-reported outcome endpoint for gastroparesis clinical trials.

Treatment options for fecal incontinence.

PURPOSE: Fecal incontinence is a socially devastating disorder which affects at least 2.2 percent of community dwelling adults and 45 percent of nursing home residents. Most incontinent patients can be helped, but physicians are poorly informed about treatment options. The aim of this study was to develop a consensus on treatment options by convening a conference of surgeons, gastroenterologists, nurses, psychologists, and patient advocates. METHOD: A 1-1/2 day conference was held in April, 1999. Experts from different disciplines gave overviews, followed by extended discussions. Consensus statements were developed at the end of the conference. This summary statement was drafted, circulated to all participants, and revised based on their input. CONCLUSIONS: 1) Diarrhea is the most common aggravating factor for fecal incontinence, and antidiarrheal medications such as loperamide and diphenoxylate or bile acid binders may help. Fecal impaction, a common cause of fecal incontinence in children and elderly patients, responds to combinations of laxatives, education, and habit training in approximately 60 percent. These causes of fecal incontinence can usually be identified by history and physical examination alone. 2) In patients who fail medical management or have evidence of sphincter weakness, anorectal manometry and endoanal ultrasound are recommended as helpful in differentiating simple morphologic defects from afferent and efferent nerve injuries and from combined structural and neurologic injuries. 3) Biofeedback is a harmless and inexpensive treatment which benefits approximately 75 percent of patients but cures only about 50 percent. It may be most appropriate when there is neurologic injury (i.e., partial denervation), but it has been reported to also benefit incontinent patients with minor structural defects. 4) External anal sphincter plication with or without pelvic floor repair is indicated when there is a known, repairable structural defect without significant neurologic injury. It is effective in approximately 68 percent. 5) Salvage operations are reserved for patients who can not benefit from biofeedback or levator-sphincteroplasty. These include electrically stimulated gracilis muscle transpositions and colostomy. 6) Antegrade enemas delivered through stomas in the cecum or descending colon reduce or eliminate soiling in approximately 78 percent of children with myelomeningocele; this operation may come to be more widely applied. 7) Investigational treatments include implanted nerve stimulators, artificial sphincters, and anal plugs. 8) Patient characteristics which influence choice of treatment include mental status, mobility impairment, and typical bowel habits. 9) Additional research is needed to better define the mechanisms responsible for fecal incontinence, to assess the efficacy of these treatments, to develop better treatments for nursing home residents, and to identify predictors of outcome.