Partner burden in irritable bowel syndrome.

BACKGROUND & AIMS: Studies have described the burden experienced by caregivers and next of kin to patients with diseases such as cancer. However, the burden of functional gastrointestinal disorders on partners of patients has not been determined. We aimed to quantify the degree of burden to partners of patients with irritable bowel syndrome (IBS), to describe the factors that affect the burden perceived, and to identify the areas of relationship that are affected. METHODS: We surveyed 152 patients diagnosed with IBS at a tertiary gastrointestinal clinic, on the basis of Rome III criteria, and their partners. Their partners completed questionnaires including the Zarit Burden Interview (ZBI), Relationship Satisfaction Scale, and questions on sexual relationships. Patients with IBS were rated for disease severity by using the Functional Bowel Disease Severity Index. We compared findings with those from 39 partners of healthy individuals (controls). RESULTS: There were no significant demographic differences between the partners of patients with IBS and controls; demographics had no effect on burden. Burden was significantly higher among partners of IBS patients (mean ZBI score, 22.1) than controls (mean ZBI score, 11.5) (P = .0002). The degree of burden was directly related to IBS severity (P < .0001). There were inverse relationships between partners' rating of burden (ZBI) and relationship quality (R = -0.60; P < .001) and sexual satisfaction (R = -0.56; P < .0001). There was no difference in the Relationship Satisfaction Scale scores (4.25 vs 4.19; P = .78) or sexual relationship (6.47 vs 6.21; P = .64) between partners of IBS patients and controls, respectively. CONCLUSIONS: Partners of patients with IBS have a significant burden (on the basis of ZBI score), compared with partners of healthy individuals. Perceived burden increases with IBS severity and poorer sexual and relationship satisfaction.

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.

Characterization of episodes of irritable bowel syndrome using ecological momentary assessment.

OBJECTIVES: Patients with irritable bowel syndrome (IBS) report that symptoms occur as episodes. The nature and frequency of episodes have not been well studied. METHODS: Using modified ecological momentary assessment (EMA), we examined clinical factors attributed to IBS symptom episodes and compared them with nonsymptom episode periods in patients with IBS-D (N=21), IBS-C (N=18), or IBS-M (N=19), and healthy controls (N=19). Symptoms were rated over 14 days on a visual ordinal scale (VOS: 0-10) randomly in morning, midday, and evening, and at wake up, bedtime, prebowel movement, and postbowel movement. Scores were evaluated for total group and across subgroups and between EMA and daily diary cards on the same day. RESULTS: Subjects (n=57/59) reported symptom episodes 34% of the time. Episodes showed significantly higher pain levels (3.6 vs. 1.64, P<0.0001), bloating (4.57 vs. 3.02, P<0.0001), stress (3.54 vs. 2.59, P<0.0001), and decreased well-being (5.29 vs. 6.16, P<0.0001). Episode frequency/2 weeks was greatest for IBS-D (10.7±7.05) than IBS-C (8.4±5.76) and IBS-M (7.1±4.45) (P=nonsignificant). IBS-D also had shorter episodes (9 h 23 min) compared with IBS-M (15 h 01 min) and IBS-C (15 h 25 min) (P<0.04). Stool frequency and looser consistency were greater with IBS-D and similar between IBS-C and IBS-M. Abdominal pain was the greatest predictor of episode status. Diary card ratings of pain and stool frequency overestimate levels reported by EMA. CONCLUSIONS: Episodes of IBS are associated with greater pain (strongest relationship), bloating, and stress scores, and poorer global well-being. Compared with IBS-D, IBS-C and IBS-M are similar in clinical features. Patients overreport pain and stool frequency by diary compared with EMA.

Here's my phone number, don't call me: physician accessibility in the cell phone and e-mail era.

Physician accessibility, for example how available a doctor should be by cell phone or e-mail is an important issue that is not well understood. There can be large differences between the expectations of patients and the perspective of their providers. The rationale for providing accessibility has historical roots and relates to the very basis of the physician-patient relationship and the effects on patient outcomes. While patients may want this line of communication, physicians may worry about disruption from unexpected phone calls, being requested to provide advice without access to records and providing services without adequate remuneration among other concerns. Herein, we discuss the rationale for these concerns, and provide suggestions on how we might overcome them. We suggest a framework with guidelines on establishing and maintaining remote accessibility with patients in the context of a productive physician-patient relationship.

A focus group assessment of patient perspectives on irritable bowel syndrome and illness severity.

There is a growing need to understand from the patient's perspective the experience of irritable bowel syndrome (IBS) and the factors contributing to its severity; this has been endorsed by the Food and Drug Administration (FDA). Accordingly, we conducted focus groups to address this issue. A total of 32 patients with mostly moderate to severe IBS were recruited through advertising and were allocated into three focus groups based on predominant stool pattern. The focus groups were held using standard methodology to obtain a general assessment of the symptoms experienced with IBS, its impact, and of factors associated with self-perceived severity. Patients described IBS not only as symptoms (predominantly abdominal pain) but mainly as it affects daily function, thoughts, feelings and behaviors. Common responses included uncertainty and unpredictability with loss of freedom, spontaneity and social contacts, as well as feelings of fearfulness, shame, and embarrassment. This could lead to behavioral responses including avoidance of activities and many adaptations in routine in an effort for patients to gain control. A predominant theme was a sense of stigma experienced because of a lack of understanding by family, friends and physicians of the effects of IBS on the individual, or the legitimacy of the individual's emotions and adaptation behaviors experienced. This was a barrier to normal functioning that could be ameliorated through identifying with others who could understand this situation. Severity was linked to health-related quality of life (HRQOL) and was influenced by the intensity of abdominal pain and other symptoms, interference with and restrictions relating to eating, work, and social activities, and of the unpredictability of the condition. This study confirms the heterogeneous and multi-component nature of IBS. These qualitative data can be used in developing health status and severity instruments for larger-scale studies.

International survey of patients with IBS: symptom features and their severity, health status, treatments, and risk taking to achieve clinical benefit.

BACKGROUND: Although clinicians generally make treatment decisions in irritable bowel syndrome (IBS) related to the type of symptoms, other factors such as the perceived severity and the risks patients are willing to tolerate for effective treatment are also important to consider. These factors are not fully understood. OBJECTIVE: To describe among patients with IBS their symptoms and severity, quality of life and health status, medications taken, and the risk that they would take to continue medications for optimal relief. METHODS: Adult patients diagnosed with IBS who accessed the websites of the International Foundation for Functional GI Disorders or the University of North Carolina Center for Functional GI Disorders filled out questionnaires to address the study aims. RESULTS: The 1966 respondents (83% female, 91% white, 78% US/Canada) reported impaired health status: restricting on average 73 days of activity in a year, having poor health-related quality of life particularly with dietary restrictions, mood disturbance, and interference with daily activity, and 35% reported their symptoms as severe defined primarily as pain, bowel difficulties, bloating, and eating/dietary restrictions). These symptoms were reported in some combination by over 90%, and 35.1% endorsed all 4 items. To receive a treatment that would make them symptom free, patients would give up 25% of their remaining life (average 15 y) and 14% would risk a 1/1000 chance of death. Most of the medications being taken were for pain relief and 18% were taking narcotics. Complementary and alternative treatments were used by 37%. CONCLUSIONS: Patients accessing IBS informational websites report moderate-to-severe impairments in health status, and would take considerable risk to obtain symptom benefit. There is an unmet need to find effective treatments for patients with IBS and regulatory agencies might consider raising risk-benefit ratios when approving new medications for IBS.

Adequate relief in a treatment trial with IBS patients: a prospective assessment.

OBJECTIVES: Adequate relief (AR) of irritable bowel syndrome (IBS) symptoms (IBS-AR) has been used as a primary end point in many randomized controlled trials of IBS and is considered by the Rome III committee to be an acceptable primary end point. However, controversy exists on whether baseline severity confounds the effect of the treatment outcome. The aim (1) is to compare a subjective report of IBS-AR with global assessment of improvement (IBS-GAI), change in IBS symptom severity scale (IBS-SSS), and IBS quality of life (IBS-QOL); (2) to explore whether initial IBS symptom severity influences the ability of these outcome measures to detect differences post treatment; and (3) to determine whether psychological symptoms influence the sensitivity of these measures, in a randomized controlled treatment trial. METHODS: A total of 289 adult IBS patients were recruited to a treatment trial. Baseline IBS-SSS scores were used to classify IBS severity as mild (<175), moderate (175-300), or severe (>300). Questionnaires were completed at baseline and after 3 weeks of treatment with sham acupuncture or wait-list control. RESULTS: IBS baseline severity (IBS-SSS) significantly affected the proportion of patients who reported IBS-AR at 3 weeks (mild, 70%; moderate, 49.7%; severe, 38.8%) (P<0.05). However, once the patients who reported IBS-AR at baseline (28.0%) were excluded from the analysis, baseline severity no longer affected the proportion of patients reporting IBS-AR. Baseline severity did not have a significant effect on patients reporting moderate or significant improvement on the IBS-GAI (mild, 30%; moderate, 25.3%; severe, 18.8%) (P=NS). Psychological symptoms had no significant correlations with responders after adjusting for baseline severity. CONCLUSIONS: These data suggest that IBS-AR as an end point is inversely related to baseline symptom severity. However, if patients who report AR at screening were excluded from study participation, baseline symptom severity was no longer confounded with a report of AR at the study end point.

Complementary and alternative medicine use and cost in functional bowel disorders: a six month prospective study in a large HMO.

BACKGROUND: Functional Bowel Disorders (FBD) are chronic disorders that are difficult to treat and manage. Many patients and doctors are dissatisfied with the level of improvement in symptoms that can be achieved with standard medical care which may lead them to seek alternatives for care. There are currently no data on the types of Complementary and Alternative Medicine (CAM) used for FBDs other than Irritable Bowel Syndrome (IBS), or on the economic costs of CAM treatments. The aim of this study is to determine prevalence, types and costs of CAM in IBS, functional diarrhea, functional constipation, and functional abdominal pain. METHODS: 1012 Patients with FBD were recruited through a health care maintenance organization and followed for 6 months. Questionnaires were used to ascertain: Utilization and expenditures on CAM, symptom severity (IBS-SS), quality of life (IBS-QoL), psychological distress (BSI) and perceived treatment effectiveness. Costs for conventional medical care were extracted from administrative claims. RESULTS: CAM was used by 35% of patients, at a median yearly cost of $200. The most common CAM types were ginger, massage therapy and yoga. CAM use was associated with female gender, higher education, and anxiety. Satisfaction with physician care and perceived effectiveness of prescription medication were not associated with CAM use. Physician referral to a CAM provider was uncommon but the majority of patients receiving this recommendation followed their physician's advice. CONCLUSION: CAM is used by one-third of FBD patients. CAM use does not seem to be driven by dissatisfaction with conventional care. Physicians should discuss CAM use and effectiveness with their patients and refer patients if appropriate.

Increased colonic pain sensitivity in irritable bowel syndrome is the result of an increased tendency to report pain rather than increased neurosensory sensitivity.

OBJECTIVE: The aim was to determine whether lower visceral pain thresholds in irritable bowel syndrome (IBS) primarily reflect physiological or psychological factors. METHODS: Firstly, 121 IBS patients and 28 controls underwent balloon distensions in the descending colon using the ascending methods of limits (AML) to assess pain and urge thresholds. Secondly, sensory decision theory analysis was used to separate physiological from psychological components of perception: neurosensory sensitivity (p(A)) was measured by the ability to discriminate between 30 mm Hg vs 34 mm Hg distensions; psychological influences were measured by the report criterion-that is, the overall tendency to report pain, indexed by the median intensity rating for all distensions, independent of intensity. Psychological symptoms were assessed using the Brief Symptom Inventory (BSI). RESULTS: IBS patients had lower AML pain thresholds (median: 28 mm Hg vs 40 mm Hg; p<0.001), but similar neurosensory sensitivity (median p(A): 0.5 vs 0.5; p = 0.69; 42.6% vs 42.9% were able to discriminate between the stimuli better than chance) and a greater tendency to report pain (median report criterion: 4.0 ("mild" pain) vs 5.2 ("weak" pain); p = 0.003). AML pain thresholds were not correlated with neurosensory sensitivity (r = -0.13; p = 0.14), but were strongly correlated with report criterion (r = 0.67; p<0.0001). Report criterion was inversely correlated with BSI somatisation (r = -0.26; p = 0.001) and BSI global score (r = -0.18; p = 0.035). Similar results were seen for the non-painful sensation of urgency. CONCLUSION: Increased colonic sensitivity in IBS is strongly influenced by a psychological tendency to report pain and urge rather than increased neurosensory sensitivity.

A survey on patient educational needs in irritable bowel syndrome and attitudes toward participation in clinical research.

BACKGROUND: The educational needs of patients with irritable bowel syndrome (IBS) are poorly understood and rarely studied. AIM: To determine the educational needs of IBS patients, regarding content, presentation format, and expectations from healthcare providers. METHODS: Fifteen functional GI clinic patients were asked open-ended questions to generate items for a questionnaire addressing the study aim. A total of 104 IBS patients received this questionnaire by mail (42 had declined to participate in a prior IBS study). To assess the frequency of endorsements and importance (on a scale of 1-3) of the items, an index was calculated (frequency of endorsements x mean rating per item, first priority scored 3, third priority scored 1). A higher index indicated greater endorsement based on frequency and rating of response. RESULTS: A total of 29 (28%) subjects (22 willing, 7 unwilling to participate previously in questionnaire research) completed the questionnaire (mean age, 42.6 years; SD, 14.2 years; 19 female, 10 male). The overall low response rate is likely related to the population studied; 40.4% of our study subjects have declined participation in prior research. The response rate of those who have previously agreed to participate was 36%. The typical response profile included: interest in learning disease management (index=1.4) and preference for information presented in person by an M.D. (2.4). Choice of presentation media included magazines (1.9), television (1.5), and Web sites (1.2). Doctors' qualities ranked high related to competency (0.8), allocation of sufficient time (0.7), and listening skills (0.4). Preferred incentives for research participation included a thank you note (0.4), summary of trial results (0.3), and monetary incentives (0.6). CONCLUSIONS: This qualitative study will provide pilot data for a national survey on the educational needs of IBS patients, for use in developing effective patient-centered, educational programs.

A prospective assessment of bowel habit in irritable bowel syndrome in women: defining an alternator.

BACKGROUND & AIMS: Irritable bowel syndrome (IBS) is subtyped as IBS with diarrhea (IBS-D) or IBS with constipation (IBS-C) based on Rome II guidelines. The remaining group is considered as having mixed IBS (IBS-M). There is no standard definition of an alternator (IBS-A), in which bowel habit changes over time. Our aim was to use Rome II criteria to prospectively assess change in bowel habit for more than 1 year to understand IBS-A. METHODS: Female patients (n=317) with IBS entering a National Institutes of Health treatment trial were studied at baseline with questionnaires and 2-week daily diary cards of pain and stool frequency and consistency. Studies were repeated at the end of treatment (3 months) and at four 3-month intervals for one more year. Algorithms to classify subjects into IBS-D, IBS-C, and IBS-M groups used diary card information and modified Rome II definitions. Changes in bowel habit at 3-month intervals were then assessed using these surrogate diary card measures. RESULTS: At baseline, 36% had IBS-D, 31% IBS-M, and 34% IBS-C. Except for stool frequency, there were no differences between groups. While the proportion of subjects in each subgroup remained the same over the year, most individuals (more than 75%) changed to either of the other 2 subtypes at least once. IBS-M was the least stable (50% changed out by 12 weeks). Patients were more likely to transition between IBS-M and IBS-C than between IBS-D and IBS-M. Notably, only 29% switched between the IBS-D and IBS-C subtypes over the year. CONCLUSIONS: While the proportion of subjects in each of the IBS subtypes stays the same, individuals commonly transition between subtypes, particularly between IBS-M and IBS-C. We recommend that IBS-A be defined as at least one change between IBS-D and IBS-C by Rome II criteria over a 1-year period.