Development, content validity, and cross-cultural adaptation of a patient-reported outcome measure for real-time symptom assessment in irritable bowel syndrome.

BACKGROUND: End-of-day questionnaires, which are considered the gold standard for assessing abdominal pain and other gastrointestinal (GI) symptoms in irritable bowel syndrome (IBS), are influenced by recall and ecological bias. The experience sampling method (ESM) is characterized by random and repeated assessments in the natural state and environment of a subject, and herewith overcomes these limitations. This report describes the development of a patient-reported outcome measure (PROM) based on the ESM principle, taking into account content validity and cross-cultural adaptation. METHODS: Focus group interviews with IBS patients and expert meetings with international experts in the fields of neurogastroenterology & motility and pain were performed in order to select the items for the PROM. Forward-and-back translation and cognitive interviews were performed to adapt the instrument for the use in different countries and to assure on patients' understanding with the final items. KEY RESULTS: Focus group interviews revealed 42 items, categorized into five domains: physical status, defecation, mood and psychological factors, context and environment, and nutrition and drug use. Experts reduced the number of items to 32 and cognitive interviewing after translation resulted in a few slight adjustments regarding linguistic issues, but not regarding content of the items. CONCLUSIONS AND INFERENCES: An ESM-based PROM, suitable for momentary assessment of IBS symptom patterns was developed, taking into account content validity and cross-cultural adaptation. This PROM will be implemented in a specifically designed smartphone application and further validation in a multicenter setting will follow.

What's new in Rome IV?

The functional gastrointestinal disorders (FGIDs) are the most common disorders seen in Gastroenterology clinical practice. The Rome process has generated consensus definitions of FGIDS, allowing to subdivide patients into diagnostic categories based on the symptom pattern. The Rome IV consensus, presented in 2016, is the most recent update of this diagnostic scheme. This article summarizes the main changes, which include the use of epidemiology-based symptom thresholds to define FGIDs, characterization of FGIDS as disorders of Gut-Brain interaction, and updates of criteria for esophageal disorders, irritable bowel syndrome and Biliary and Sphincter of Oddi disorders based on scientific and technical progress made over the last decade. The Rome IV consensus provides a standard for clinical and research approach to FGIDS for the coming years.

Communication breakdown between physicians and IBS sufferers: what is the conundrum and how to overcome it?

Irritable bowel syndrome is a disorder of gut-brain interaction that leads to a significant healthcare burden worldwide. A good physician-patient relationship is fundamental in managing patients who suffer from this poorly understood chronic disease. We highlight possible reasons for breakdown in communication between physicians and irritable bowel syndrome sufferers and suggest possible ways to overcome such pitfalls.

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.

Utility of red flag symptom exclusions in the diagnosis of irritable bowel syndrome.

BACKGROUND: Studies suggest that the positive predictive value of the Rome II criteria for diagnosing irritable bowel syndrome can be enhanced by excluding red flag symptoms suggestive of organic diseases. AIM: We assessed the utility of red flags for detecting organic diseases in patients diagnosed irritable bowel syndrome by their physicians. METHODS: Systematic chart reviews were completed in 1434 patients with clinical diagnoses of irritable bowel syndrome, abdominal pain, diarrhoea or constipation, who also completed questionnaires to identify Rome II criteria for irritable bowel syndrome and red flag symptoms. RESULTS: The overall incidence of gastrointestinal cancer was 2.5% (but 1.0% in those with irritable bowel syndrome), for inflammatory bowel disease 2.0% (1.2% in irritable bowel syndrome), and for malabsorption 1.3% (0.7% in irritable bowel syndrome). Red flags were reported by 84% of the sample. The positive predictive value of individual red flags for identifying organic disease was 7-9%. Excluding any patient with a red flag improved the agreement between Rome II and clinical diagnosis by a modest 5%, but left 84% of patients who were diagnosed with irritable bowel syndrome by their physicians, without a diagnosis. CONCLUSIONS: Red flags may be useful for identifying patients who require additional diagnostic evaluation, but incorporating them into the Rome criteria would not improve sensitivity and would result in too many missed irritable bowel syndrome diagnoses.

Centrally targeted pharmacotherapy for chronic abdominal pain.

BACKGROUND: Chronic abdominal pain in the context of the functional gastrointestinal disorders departs from a more traditional approach to treating gastrointestinal symptoms. Chronic abdominal pain involves a dysregulation of brain-gut modulation of afferent signaling, so treatments directed toward the gut are not usually sufficient to achieve a clinical response. Rather the methods of treatment depend on re-establishing central pain regulation. PURPOSE: A conceptual model of predisposing, precipitating, and perpetuating factors is used to explain how a situation of chronic pain develops and it provides the evidence for central neuron degeneration as relevant to this chain of events. The rationale for centrally targeted medications, in particular antidepressants, is discussed with regard to effects independent of their role in treating psychiatric disorders: with regard to downregulation of afferent pain signals and their potential role in neuron proliferation. Finally, guiding examples of which drug to use and treatment combinations involving multiple drugs, augmentation treatment, are outlined and some brief clinical cases of centrally targeted pharmacotherapy.

Development and pilot testing of an integrated, web-based self-management program for irritable bowel syndrome (IBS).

BACKGROUND: Although essential, many medical practices are unable to adequately support irritable bowel syndrome (IBS) patient self-management. Web-based programs can help overcome these barriers. METHODS: We developed, assessed, and refined an integrated IBS self-management program (IBS Self-care). We then conducted a 12-week pilot test to assess program utilization, evaluate its association with patients' self-efficacy and quality of life, and collect qualitative feedback to improve the program. KEY RESULTS: 40 subjects with generally mild IBS were recruited via the Internet to participate in a 12-week pilot study. Subjects found the website easy to use (93%) and personally relevant (95%), and 90% would recommend it to a friend. Self-rated IBS knowledge increased from an average of 47.1 on a 100-point VAS scale (SD 22.1) at baseline to 77.4 (SD: 12.4) at week 12 (p < 0.0001). There were no significant changes in patient self-efficacy (Patient Activation Measure) or quality of life (IBS -Quality of Life Scale). CONCLUSIONS & INFERENCES: The IBS Self-Care program was well received by users who after 12 weeks reported improved knowledge about IBS, but no significant changes in self-efficacy or quality of life. If applied to the right population, this low cost solution can overcome some of the deficiencies of medical care and empower individuals to better manage their own IBS.

Patients with psychogenic abdominal pain: six years' observation in the medical setting.

The author presents data on 24 patients with psychogenic abdominal pain who were followed by nonpsychiatric physicians for up to 6 years. Twenty were women, many of whose symptoms related to loss. Several personality patterns were observed, including histrionic personality, depression, pain-prone personality, and hypochondriasis. No patient sought psychiatric care, although 4 patients eventually required psychiatric hospitalization. Two patients had medical disorders that contributed to the symptoms, and 1 patient died of carcinoma. Pain resolved in only 1 of the patients, but psychosocial functioning improved in half. Those with a shorter duration of pain and no abnormal personality patterns had a better prognosis.

Panic disorder and gastrointestinal symptoms: findings from the NIMH Epidemiologic Catchment Area project.

OBJECTIVE: Clinical experience and recent reports suggest that there is a high prevalence of gastrointestinal symptoms in patients with panic disorder and that there is a high prevalence of panic disorder in patients with irritable bowel syndrome, a functional gastrointestinal disorder. To assess gastrointestinal symptoms in a nonpatient, community-based sample, the authors surveyed the prevalence of gastrointestinal symptoms in individuals with panic disorder and other or no psychiatric disorders obtained in a national community survey. METHOD: Subjects were 13,537 respondents at four sites of the National Institute of Mental Health (NIMH) Epidemiological Catchment Area project. DSM-III diagnoses were determined by using the NIMH Diagnostic Interview Schedule (DIS). Gastrointestinal symptoms were assessed from the somatization disorder section of the DIS. RESULTS: Individuals with panic disorder had a significantly higher rate of endorsing gastrointestinal symptoms, including those typically associated with irritable bowel syndrome, than those with other or no psychiatric diagnosis. CONCLUSIONS: Findings suggest a diagnostic overlap between panic disorder and irritable bowel syndrome, with similar demographic and clinical characteristics of patients. Limitations of the study are discussed in terms of medical assessment and self-report inventories. Practical and theoretical implications are discussed.

Do psychosocial factors define symptom severity and patient status in irritable bowel syndrome?

Psychological difficulties in patients with irritable bowel syndrome (IBS) are strongly related to symptom severity and patient status. This has important implications for clinical practice, and the design and conduct of clinical trials. Psychosocial factors (personality, psychiatric diagnosis illness behavior, life stress, psychological distress) distinguish patients with IBS from patients with no IBS. Psychosocial difficulties (e.g., history of physical or sexual abuse, maladaptive coping, or "catastrophizing") predict poorer health outcome (greater pain scores, psychologic distress and poorer daily function, more days spent in bed, and more frequent physician visits and surgeries). When using the standardized Functional Bowel Disorder Severity Index, patients classified as severe are distinguished from moderates by several psychosocial difficulties and health-care use variables. In addition, whereas patients with severe illness report more pain, there is no difference from patients with moderate illness in terms of visceral sensation threshold. Given these data, it is important to consider psychosocial factors as predictive of symptom severity and clinical outcome, and this should be considered in clinical care and the design of clinical trials.

Review article: an integrated approach to the irritable bowel syndrome.

Our understanding of the pathophysiology of irritable bowel syndrome (IBS) has evolved from a disorder of motility to a more integrated understanding of enhanced motility and visceral hypersensitivity associated with brain-gut dysfunction. Psychosocial factors contribute to the predisposition, precipitation and perpetuation of IBS symptoms, and affect the clinical outcome. Newer brain imaging techniques (e.g. PET, fMRI) may help us understand the relationship between altered emotional states with pain enhancement and other gastrointestinal symptoms. Diagnosis using symptom-based (e.g. Rome) criteria and a conservative diagnostic approach is recommended. Treatment is based on an effective physician-patient relationship and a combined pharmacological and behavioural approach. Newer medications acting at the 5-HT receptor may help in reducing pain and bowel dysfunction. For more severe pain, antidepressants may be considered.

The usual medical care for irritable bowel syndrome.

AIMS: To determine what constitutes usual medical care for irritable bowel syndrome, which patient characteristics influence choice of treatment and how satisfied patients are with care. METHODS: Patient encounters in a health maintenance organization were prospectively monitored to identify visits coded irritable bowel syndrome, abdominal pain, constipation or diarrhoea. Within 2 weeks these patients were sent postal questionnaires (n = 1770, 59% participation) to assess patient characteristics and treatment recommendations. Responders were sent follow-up questionnaires 6 months later (77% participation) to assess adherence and satisfaction with treatment. RESULTS: Treatments employed most frequently were dietary advice, explanation, exercise advice, reassurance, advice to reduce stress and antispasmodic medications. Primary care physicians and gastroenterologists provided similar treatments. Patient confidence was higher for lifestyle advice (63-67, 100-point scale) than for medications (46-59). However, adherence was greater for medications (62-79 vs. 59-69, 100-point scale). Satisfactory relief was reported by 57%, but only 22% reported that symptom severity was reduced by half. Usual medical treatment was less effective for irritable bowel syndrome than for constipation, diarrhoea, or abdominal pain. CONCLUSIONS: Usual medical care for irritable bowel syndrome emphasizes education and lifestyle modification more than drugs; patients have a greater expectation of benefit from lifestyle modification than drugs. Overall 57% of irritable bowel syndrome patients report satisfactory relief.

Improvement in pain and bowel function in female irritable bowel patients with alosetron, a 5-HT3 receptor antagonist.

BACKGROUND: No currently available treatment provides consistent relief of irritable bowel syndrome. Colonic sensory and motor function are modulated partly through 5HT3-receptors. AIM: To evaluate effects of the 5HT3-receptor antagonist, alosetron, in irritable bowel syndrome. METHODS: Randomized, double-blind, placebo-controlled, dose-ranging (1, 2, 4, 8 mg b.d. alosetron), 12-week trial in 370 patients with diarrhoea-predominant or alternating constipation and diarrhoea irritable bowel syndrome. Weekly measurement of adequate relief was the key end-point; other irritable bowel syndrome symptoms were collected daily using an electronic phone system. RESULTS: Alosetron (1 mg or 2 mg b.d.) significantly (P < 0.05 vs. placebo) increased the proportion of females, but not males, reporting adequate relief. Stool consistency, frequency and percentage days with urgency improved over placebo (P < 0.05) within the first month with all doses of alosetron, and persisted throughout the trial with all doses in female patients. With 1 mg b.d. alosetron, females had improved stool consistency and urgency within the first week, and adequate relief and improved stool frequency within the first 2 weeks. There was no consistent improvement in bowel function among male patients. CONCLUSION: In female irritable bowel syndrome patients with predominant diarrhoea or alternating constipation and diarrhoea, alosetron is effective in treatment of abdominal pain and discomfort and bowel-related symptoms.

Psychologic and psychiatric aspects of gastrointestinal disease.

There has been an explosion in understanding of the psychosocial concomitants of functional gastrointestinal disorders. Detecting psychologic disturbance and eliciting a history of physical or sexual abuse are critical in suggesting comprehensive and efficacious treatment strategies for these patients. The challenge is to define further the use of psychopharmacologic agents, including the newer antidepressants, anticonvulsants, and anxiolytic agents, in the treatment of chronic functional gastrointestinal disorders. Further research to evaluate the usefulness of various forms of psychotherapeutic and behavioral interventions needs to be undertaken. Establishing a multicomponent treatment program delivered by a team of caregivers, each bringing their unique skills (internist, psychiatrist, psychologist, and others) to patients, must be based on further research on the efficacy of these modalities as opposed to empiric treatment.

Irritable bowel syndrome and sexual/physical abuse history.

There is growing evidence that a history of sexual or physical abuse can affect emotional and physical well-being. Within gastroenterology, attention has focused on the increased frequency of abuse history, particularly for patients with refractory functional gastrointestinal (GI) disorders. Furthermore, regardless of diagnosis, abuse history can impair health status and one's ability to cope with one's medical condition. Especially for patients with painful functional GI disorders resistant to usual treatments, the physician should inquire in a supportive manner about the possibility of a prior abuse history or other psychosocial traumas (e.g., major loss). This can then lead to an appropriate mental health referral (along with continued medical care) and an improved clinical outcome.

Measuring quality of life in inflammatory bowel disease.

In this study, the authors developed a disease-specific health related quality-of-life (HRQOL) measure that differentiated patients with ulcerative colitis (with and without surgery) from patients with Crohn's disease (with and without surgery). The purpose of the measure, which was facilitated by a questionnaire, was to produce a patient-orientated HRQOL index applicable to physicians' day-to-day management, and to provide a quality assurance mechanism to assess outcomes for these chronic diseases. The interview-directed questionnaire contained 47 items covering the following 4 domains: functional/economic, social/recreational, affect/life, and medical/symptoms. The items were selected by the authors from clinical experience and literature review, and showed good test-retest reliability over a 2-week period. The questionnaire had construct validity based on those items that correlated with the Sickness Impact Profile (SIP), a standardised generic health profile measure. From the 47 questions, a quality-of-life index was constructed by condensing the questionnaire to include only those 18 items that significantly differentiated between the 4 patient groups. Using this questionnaire, the authors studied 164 ambulatory patients (94 with ulcerative colitis, 70 with Crohn's disease) from a registry developed at the Cleveland Clinic. All patients had had their illness for at least 10 years, and 62% had undergone surgery because of it. When comparing the groups, the authors found that patients with ulcerative colitis had a better quality of life than those with Crohn's disease. In addition, patients who had not had surgery for their disease had a better quality of life than those who had.(ABSTRACT TRUNCATED AT 250 WORDS)

Factor analysis of bowel symptoms in US and Italian populations.

BACKGROUND AND AIMS: Functional gastrointestinal disorders are diagnosed by the presence of a characteristic set of symptoms. Aims of this study were to validate the Rome symptom criteria by factor analysis and to determine whether symptoms cluster in the same way in different cultures. METHODS: One thousand forty-one gastroenterology clinic patients in the US (response rate 53%) and 228 family members accompanying clinic patients in Italy (84%) completed a previously validated symptom questionnaire. Factor analysis identified clusters of symptoms which are highly correlated with each other, and these were compared to the Rome diagnostic criteria. RESULTS: In the US, 13 factors were identified. The irritable bowel factor was composed of three core symptoms corresponding to the Rome II classification system. Two dyspepsia factors were identified which correspond to the ulcer- and motility-like subtypes proposed in the Rome I classification system. All symptoms of constipation formed a single cluster as proposed in the Rome II classification system. Symptom clusters in the US agreed well with symptom clusters identified in Italian subjects. CONCLUSIONS: Empirically derived symptom clusters agree in most respects with the Rome II classification system and support their validity. These symptom clusters are independent of cultural differences in diet and behaviour.

Psychosocial aspects of Crohn's disease.

In clinical practice, significant discrepancies occur between disease activity and severity, and the patient's symptom experience and behavior. Discrepancies cannot be explained by biologic or morphologic findings, and usually are considered to be related to psychosocial factors. Recent advances in the scientific understanding of the relationship between environmental stress and the neural, endocrine, and immune systems, combined with new methodologies in clinical research, provide a challenging opportunity for clinicians and researchers to establish a more comprehensive understanding of Crohn's disease. This article reviews the important relationship of psychosocial factors, pathogenesis, clinical expression, response to treatment, and outcome of Crohn's disease, and presents a comprehensive model of illness, disease, and ways to integrate psychosocial factors with diagnosis and patient care.

Validity of the Family APGAR in patients with irritable bowel syndrome.

BACKGROUND: This study explores the validity of the Family APGAR (adaptability, partnership, growth, affection, and resolve), a test of family function, in persons with irritable bowel syndrome (IBS). Previous studies have reported increased stress in persons with IBS in the form of marital and interpersonal relationships. METHODS: The Family APGAR and the MMPI were completed by 198 persons, including 58 who sought care for IBS, 67 with IBS who did not seek care, and 73 who did not have the disorder. Family APGAR scores were compared for the three groups using analysis of variance. Multiple regression analysis was used to compare Family APGAR scores with both IBS group status and MMPI K and L scales. An odds ratio was calculated for the two groups with IBS. RESULTS: Mean Family APGAR scores were in the normal range for all three groups and differed by less than 1 point among the groups. The Family APGAR score did not differentiate among persons with IBS but was strongly related to the MMPI K score, a measure of defensiveness in test taking. CONCLUSIONS: The failure of the Family APGAR to detect the family dysfunction found by psychological interviewing and the strong relationship with the MMPI K scale lead us to question the construct validity of the APGAR. More sophisticated test construction is necessary to measure family dysfunction in patients who may tend to respond defensively.

Newer aspects of the irritable bowel syndrome.

IBS is a challenging, functional GI disorder that affects many individuals around the world. Early life experiences, the biologic nature of the condition, and the psychosocial milieu interact to affect the severity and outcome of symptoms. Most people do not seek medical attention for their GI symptoms, or they require intermittent, limited medical therapy and assurance from their physician. Fewer patients, but still a significant number, demand frequent interaction with their physician, who may select pharmacotherapy or psychological and behavioral treatments to control symptoms, depending on the severity. A biopsychosocial approach with attention to the patient-doctor relationship is recommended as the basis for treatment.