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.

Long-term prognosis in Crohn's disease: factors that affect quality of life.

BACKGROUND: There are many studies investigating quality of life in recently diagnosed patients and following surgery for Crohn's disease, but there are none investigating quality of life changes with disease duration. The response shift model suggests quality of life improves with time following diagnosis. AIM: To assess how well the model applies to patients with Crohn's disease. METHODS: The Cardiff Crohn's disease database contains data on all patients diagnosed there since 1934. Three hundred and ninety four patients diagnosed before 1 January 1985 were traced and the mortality status on 31 December 2004 established. Two hundred and eleven still living were sent quality of life questionnaires. Two hundred and eighty five questionnaires were sent to patients with varying disease duration attending out-patient clinics in Leicester. RESULTS: Eighty-nine valid replies were received from Cardiff, 63 from Leicester patients diagnosed over 20 years, 69 from Leicester patients diagnosed <10 years. There was no difference in quality of life between newly diagnosed and established patients. Of greatest concern was possible need for ostomy, uncertain nature of disease, and lack of energy. Stepwise regression showed that increased disease severity, older age and smoking adversely affect quality of life. DISCUSSION: Quality of life is equally poor in patients with established disease as in those newly diagnosed, and directly correlates with disease severity. The response shift model may not be applicable in Crohn's disease.

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.

Brain-gut connections in functional GI disorders: anatomic and physiologic relationships.

Understanding the neural regulation of gut function and sensation makes it easier to understand the interrelatedness of emotionality, symptom-attentive behavior or hypervigilance, gut function and pain. The gut and the brain are highly integrated and communicate in a bidirectional fashion largely through the ANS and HPA axis. Within the CNS, the locus of gut control is chiefly within the limbic system, a region of the mammalian brain responsible for both the internal and external homeostasis of the organism. The limbic system also plays a central role in emotionality, which is a nonverbal system that facilitates survival and threat avoidance, social interaction and learning. The generation of emotion and associated physiologic changes are the work of the limbic system and, from a neuroanatomic perspective, the 'mind-body interaction' may largely arise in this region. Finally, the limbic system is also involved in the 'top down' modulation of visceral pain transmission as well as visceral perception. A better understanding of the interactions of the CNS, ENS and enteric immune system will significantly improve our understanding of 'functional' disorders and allow for a more pathophysiologic definition of categories of patients currently lumped under the broad umbrella of FGID.

Effects of baseline abdominal pain and bloating on response to lubiprostone in patients with irritable bowel syndrome with constipation.

BACKGROUND: Lubiprostone (8 µg b.d.) received US Food and Drug Administration (FDA) approval in 2008 for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) in women aged ≥18 years. In 2012, the FDA issued new guidance for IBS-C clinical trials, recommending a composite endpoint incorporating both abdominal pain and stool frequency. AIM: In a post hoc analysis, similar criteria were applied to data from two pivotal, phase 3, double-blind, randomised trials of lubiprostone in patients with IBS-C. METHODS: Included patients had a baseline spontaneous bowel movement (SBM) frequency <3/week and abdominal pain or bloating ratings ≥1.36 on a 5-point scale [0 (absent) to 4 (very severe)]. Responders (composite endpoint) had a mean pain reduction ≥30% compared with baseline, and an increase from baseline of ≥1 SBM/week for ≥6 of the 12 treatment weeks. Lubiprostone effects on abdominal pain alone were also evaluated, as were bloating alone and in a composite endpoint with stool frequency. RESULTS: In pooled data, 325 patients received lubiprostone and 180 received placebo. Rates of response were higher with lubiprostone vs. placebo for the composite endpoint of improved pain and stool frequency (26.3% vs. 15.3%, respectively; P = 0.008) and the composite endpoint of improved bloating and stool frequency (23.8% vs. 12.6%, respectively; P = 0.012). Response rates were also higher with lubiprostone vs. placebo for abdominal pain alone (P = 0.005) and bloating alone (P = 0.012). CONCLUSION: Lubiprostone was significantly more effective than placebo in improving abdominal pain or bloating, and also in composite endpoints that included stool frequency.

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.

Foetal "black bone" MRI: utility in assessment of the foetal spine.

OBJECTIVE: Foetal CT has recently been added to the foetal imaging armamentarium, but this carries with it the risks of ionizing radiation, both to the mother and the foetus. Foetal "black bone" MRI is a new technique that allows assessment of the foetal skeleton without the risk of exposure to ionizing radiation and is a potential new sequence in foetal MRI examination. METHODS: Retrospective review of all foetal MRI studies over the past 4- to 5-year period identified 36 cases where susceptibility weighted imaging was used. Cases were selected from this group to demonstrate the potential utility of this sequence. RESULTS: This sequence is most frequently useful not only in the assessment of spinal abnormalities, most commonly the bony abnormalities in myelomeningocele, but also in cases of scoliosis, segmentation anomalies and sacrococcygeal teratoma. CONCLUSION: Although the utility of this sequence is still being evaluated, it provides excellent contrast between the mineralized skeleton and surrounding soft tissues compared with standard half Fourier acquisition single-shot turbo-spin echo sequences. Further assessment is required to determine whether black bone MRI can more accurately evaluate the level of bony defect in spina bifida aperta, an important prognostic factor. Potential further uses include the assessment of skeletal dysplasias, evaluation of the skull base and craniofacial skeleton in certain congenital anomalies and the post-mortem evaluation of the foetal skeleton potentially obviating the need for necropsy. ADVANCES IN KNOWLEDGE: Foetal black bone MRI can be performed using susceptibility weighted imaging and allows better demonstration of the mineralized skeleton compared with standard sequences.

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)