A common language for Gulf War Illness (GWI) research studies: GWI common data elements.

AIMS: The Gulf War Illness programs (GWI) of the United States Department of Veteran Affairs and the Department of Defense Congressionally Directed Medical Research Program collaborated with experts to develop Common Data Elements (CDEs) to standardize and systematically collect, analyze, and share data across the (GWI) research community. MAIN METHODS: A collective working group of GWI advocates, Veterans, clinicians, and researchers convened to provide consensus on instruments, case report forms, and guidelines for GWI research. A similar initiative, supported by the National Institute of Neurologic Disorders and Stroke (NINDS) was completed for a comparative illness, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and provided the foundation for this undertaking. The GWI working group divided into two sub-groups (symptoms and systems assessment). Both groups reviewed the applicability of instruments and forms recommended by the NINDS ME/CFS CDE to GWI research within specific domains and selected assessments of deployment exposures. The GWI CDE recommendations were finalized in March 2018 after soliciting public comments. KEY FINDINGS: GWI CDE recommendations are organized in 12 domains that include instruments, case report forms, and guidelines. Recommendations were categorized as core (essential), supplemental-highly recommended (essential for specified conditions, study types, or designs), supplemental (commonly collected, but not required), and exploratory (reasonable to use, but require further validation). Recommendations will continually be updated as GWI research progresses. SIGNIFICANCE: The GWI CDEs reflect the consensus recommendations of GWI research community stakeholders and will allow studies to standardize data collection, enhance data quality, and facilitate data sharing.

Identifying and Treating Nonalcoholic Fatty Liver Disease.

NAFLD improves with 7% or greater weight loss.

Preventing Hepatitis B Reactivation During Anti-CD20 Antibody Treatment in the Veterans Health Administration.

Hepatitis B virus (HBV) reactivation may occur with high risk immunosuppression, such as anti-cluster of differentiation (CD)20 antibodies (Abs). Appropriate HBV prophylaxis during anti-CD20 Ab therapy averts hepatitis, chemotherapy disruption, and death. Serologic evidence of prior HBV exposure is present in one in nine veterans in the Veterans Health Administration (VHA). In 2014, most (61%-73%) patients in the VHA who were receiving anti-CD20 Ab treatment underwent HBV testing, yet <20% of eligible patients received HBV antiviral prophylaxis. We aimed to prevent HBV reactivation by increasing HBV testing and antiviral treatment rates among anti-CD20 Ab recipients through prospective interventions. A multidisciplinary team of clinicians, pharmacists, and public health professionals developed comprehensive prevention systems, including national seminars/newsletters/websites; pharmacy criteria for HBV screening/treatment prior to anti-CD20 Ab use; changes to national formulary restrictions to expand HBV prophylaxis prescribing authority; Medication Use Evaluation Tracker to identify omissions; national e-mail alert to all VHA oncology providers detailing specific testing and HBV antiviral treatment needs; and a voluntary electronic medical record "order check" used at interested facilities (n = 11) to automatically assess pretreatment HBV testing and antiviral treatment and only generate a reminder to address deficiencies. Analysis of monthly data from June 2016 through September 2017 among anti-CD20 Ab recipients revealed pre-anti-CD20 Ab treatment HBV testing increased to 91%-96% and appropriate HBV antiviral prophylaxis to 76%-85% nationally following implementation of the intervention. Medical centers using the voluntary electronic medical record order check increased HBV testing rates to 93%-98% and HBV antiviral prophylaxis rates to 99%. Conclusion: Multimodal intervention systems to prevent HBV reactivation among VHA patients receiving anti-CD20 Ab therapies increased national rates of HBV testing to >90% and antiviral prophylaxis to >80%.

Correction to: Identifying Nonalcoholic Fatty Liver Disease Advanced Fibrosis in the Veterans Health Administration.

The original version of the article unfortunately contained errors in Table 3, Risk Factor column headings "Age > 50 (n = 115)," "Age > 50-64 (n = 154)," and "Age > 65 + (n = 60)."

Identifying Nonalcoholic Fatty Liver Disease Advanced Fibrosis in the Veterans Health Administration.

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease. Severe NAFLD with advanced fibrosis results in substantial morbidity and mortality. Associated with metabolic syndrome, NAFLD is often initially clinically silent, yet intensive lifestyle intervention with 7% or greater weight loss can improve or resolve NAFLD. Using a Veterans Health Administration (VHA) liver biopsy cohort, we evaluated simple noninvasive fibrosis scoring systems to identify NAFLD with advanced fibrosis (or severe disease) to assist providers. METHODS: In our retrospective study of a national VHA sample of patients with biopsy-proven NAFLD or normal liver (2005-2015), we segregated patients by fibrosis stage (0-4). Non-NAFLD liver disease was excluded. We evaluated the diagnostic accuracy of the NAFLD fibrosis score (NFS), fibrosis-4 calculator (FIB-4), aspartate aminotransferase-to-alanine aminotransferase ratio (AST/ALT ratio), AST-to-platelet ratio index (APRI), and body mass index, AST/ALT ratio, and diabetes (BARD) score by age groups. RESULTS: We included 329 patients with well-defined liver histology (296 NAFLD and 33 normal controls without fibrosis), in which 92 (28%) had advanced (stage 3-4) fibrosis. Across all age groups, NFS and FIB-4 best predicted advanced fibrosis (NFS with 0.676 threshold: AUROC 0.71-0.76, LR + 2.30-22.05, OR 6.00-39.58; FIB-4 with 2.67 threshold: AUROC of 0.62-0.80, LR + 4.70-27.45, OR 16.34-59.65). CONCLUSIONS: While NFS and FIB-4 scores exhibit good diagnostic accuracy, FIB-4 is optimal in identifying NAFLD advanced fibrosis in the VHA. Easily implemented as a point-of-care clinical test, FIB-4 can be useful in directing patients that are most likely to have advanced fibrosis to GI/hepatology consultation and follow-up.

Jump starting shared medical appointments for diabetes with weight management: Rationale and design of a randomized controlled trial.

BACKGROUND: Rates of glycemic control remain suboptimal nationwide. Medication intensification for diabetes can have undesirable side effects (weight gain, hypoglycemia), which offset the benefits of glycemic control. A Shared Medical Appointment (SMA) intervention for diabetes that emphasizes weight management could improve glycemic outcomes and reduce weight while simultaneously lowering diabetes medication needs, resulting in less hypoglycemia and better quality of life. We describe the rationale and design for a study evaluating a novel SMA intervention for diabetes that primarily emphasizes low-carbohydrate diet-focused weight management. METHODS: Jump Starting Shared Medical Appointments for Diabetes with Weight Management (Jump Start) is a randomized, controlled trial that is allocating overweight Veterans (body mass index≥27kg/m2) with type 2 diabetes into two arms: 1) a traditional SMA group focusing on medication management and self-management counseling; or 2) an SMA group that combines low-carbohydrate diet-focused weight management (WM/SMA) with medication management. Hemoglobin A1c reduction at 48weeks is the primary outcome. Secondary outcomes include hypoglycemic events, diabetes medication use, weight, medication adherence, diabetes-related quality of life, and cost-effectiveness. We hypothesize that WM/SMA will be non-inferior to standard SMA for glycemic control, and will reduce hypoglycemia, diabetes medication use, and weight relative to standard SMA, while also improving quality of life and costs. CONCLUSIONS: Jump Start targets two common problems that are closely related but infrequently managed together: diabetes and obesity. By focusing on diet and weight loss as the primary means to control diabetes, this intervention may improve several meaningful patient-centered outcomes related to diabetes.

A Coaching by Telephone Intervention for Veterans and Care Team Engagement (ACTIVATE): A study protocol for a Hybrid Type I effectiveness-implementation randomized controlled trial.

INTRODUCTION: A large proportion of deaths and many illnesses can be attributed to three modifiable risk factors: tobacco use, overweight/obesity, and physical inactivity. Health risk assessments (HRAs) are widely available online but have not been consistently used in healthcare systems to activate patients to participate in prevention programs aimed at improving lifestyle behaviors. OBJECTIVES: The goal of this study is to test whether adding telephone-based coaching to use of a comprehensive HRA increases at-risk patients' activation and enrollment into a prevention program compared to HRA use alone. METHODS: Participants were randomized to either complete an HRA alone or in conjunction with a telephone coaching intervention. To be eligible Veterans had to have at least one modifiable risk factor (current smoker, overweight/obese, or physically inactive). The primary outcome is enrollment and participation in a prevention program by 6months. Secondary outcomes include change in a Patient Activation Measure and Framingham Risk Score. DISCUSSION: This study is the first to test a web-based health risk assessment coupled with a health coaching intervention within a large healthcare system. Results from this study will help the Veterans Health Administration (VHA) implement its national plan to include comprehensive health risk assessments as a tool to engage Veterans in prevention. The results will also inform health systems outside VHA who seek to implement Medicare's advisement that health risk assessment become a mandatory component of care under the Affordable Care Act.

Factors associated with choice of a low-fat or low-carbohydrate diet during a behavioral weight loss intervention.

Individuals undertaking a weight loss effort have a choice among proven dietary approaches. Factors contributing to choice of either a low-fat/low-calorie diet or a low-carbohydrate diet, two of the most studied and popular dietary approaches, are unknown. The current study used data from participants randomized to the 'choice' arm of a trial examining whether being able to choose a diet regimen yields higher weight loss than being randomly assigned to a diet. At study entry, participants attended a group session during which they were provided tailored feedback indicating which diet was most consistent with their food preferences using the Geiselman Food Preference Questionnaire (FPQ), information about both diets, and example meals for each diet. One week later, they indicated which diet they chose to follow during the 48-week study, with the option of switching diets after 12 weeks. Of 105 choice arm participants, 44 (42%) chose the low-fat/low-calorie diet and 61 (58%) chose the low-carbohydrate diet. In bivariate analyses, diet choice was not associated with age, race, sex, education, BMI, or diabetes (all p > 0.05). Low-carbohydrate diet choice was associated with baseline higher percent fat intake (p = 0.007), lower percent carbohydrate intake (p = 0.02), and food preferences consistent with a low-carbohydrate diet according to FPQ (p < 0.0001). In a multivariable logistic regression model, only FPQ diet preference was associated with diet choice (p = 0.001). Reported reasons for diet choice were generally similar for those choosing either diet; however, concerns about negative health effects of the unselected diet was rated as more influential among participants selecting the low-fat diet. Only three low-carbohydrate and two low-fat diet participants switched diets at 12 weeks. Results suggest that when provided a choice between two popular weight loss dietary approaches, an individual's selection is likely influenced by baseline dietary intake pattern, and especially by his or her dietary preferences. Research is needed to determine if congruency between food preferences and dietary approach is associated with weight loss.

Considering patient diet preference to optimize weight loss: design considerations of a randomized trial investigating the impact of choice.

A variety of diet approaches achieve moderate weight loss in many individuals. Yet, most diet interventions fail to achieve meaningful weight loss in more than a few individuals, likely due to inadequate adherence to the diet. It is widely conjectured that targeting the diet to an individual's food preferences will enhance adherence, thereby improving weight loss. This article describes the design considerations of a study protocol aimed at testing this hypothesis. The study is a 2-arm randomized trial recruiting 216 medical outpatients with BMI ≥30 kg/m(2) followed for 48 weeks. Participants in the experimental arm (Choice) select from two of the most widely studied diets for weight loss, a low-carbohydrate, calorie-unrestricted diet (LCD) or a low-fat, reduced-calorie diet (LFD). The participant's choice is informed by results from a validated food preference questionnaire and a discussion of diet options with trained personnel. Choice participants are given the option to switch to the other diet after three months, if desired. Participants in the Control arm are randomly assigned to follow one of the two diets for the duration of follow-up. The primary outcome is weight assessed every 2-4 weeks for 48 weeks. Secondary outcomes include adherence to diet by food frequency questionnaire and obesity-specific health-related quality of life. If assisting patients to choose their diet enhances adherence and increases weight loss, the results will support the provision of diet options to patients who desire weight loss, and bring us one step closer to remediating the obesity epidemic faced by our healthcare systems.

Obstetric sphincter injury interacts with diarrhea and urgency to increase the risk of fecal incontinence in women with irritable bowel syndrome.

OBJECTIVES: This study aimed to confirm that fecal urgency and diarrhea are independent risk factors for fecal incontinence (FI), to identify obstetrical risk factors associated with FI in women with irritable bowel syndrome, and to determine whether obstetric anal sphincter injuries interact with diarrhea or urgency to explain the occurrence of FI. METHODS: The study is a supplement to a diary study of bowel symptoms in 164 female patients with irritable bowel syndrome. Subjects completed daily bowel symptom diaries for 90 consecutive days and rated each bowel movement for stool consistency and presence of urgency, pain, and FI. All female participants from the parent study were invited to complete a telephone-administered 33-item bowel symptom and obstetric history questionnaire, which included the fecal incontinence severity index. RESULTS: Of the 164 women in the parent study, 115 (70.1%) completed the interview. Seventy-four (45.1%) reported FI on their diary including 34 (29.6%) who reported at least 1 episode per month, 112 (97.4%) reported episodes of urgency, and 106 (92.2%) reported episodes of diarrhea. The mean fecal incontinence severity index score was 13.9 (9.7). On multivariable analysis, FI was significantly associated with parity (P = 0.007), operative abdominal delivery (P = 0.049), obstetrical sphincter lacerations (P = 0.007), fecal urgency (P = 0.005), diarrhea (P = 0.008), and hysterectomy (P = 0.004), but was not associated with episiotomy, pelvic organ prolapse, or urinary incontinence. The synergistic interactions of obstetric anal sphincter laceration with urgency (P = 0.002) and diarrhea (P = 0.004) were significant risk factors for FI. CONCLUSIONS: Fecal urgency and diarrhea are independent risk factors for FI, and they interact with obstetric anal sphincter laceration to amplify the risk of FI.

Development and validation of new disease-specific measures of somatization and comorbidity in IBS.

OBJECTIVE: To create and validate empirically derived questionnaires that measure non-gastrointestinal symptoms and disorders that co-exist with irritable bowel syndrome (IBS). METHODS: A systematic review of the world literature identified all non-GI symptoms and diagnoses known to have excess frequency in IBS patients. These data were used to create the Recent Physical Symptoms Questionnaire (RPSQ), which measures somatization (the psychological tendency to report multiple physical symptoms), and the Comorbid Medical Conditions Questionnaire (CMCQ). The psychometric properties of these questionnaires were assessed in two studies: 109 IBS patients in Study I; 286 IBS patients and 67 healthy controls in Study II. RESULTS: In Study I, the RPSQ and CMCQ showed high test-retest reliability (r=.88 and .95) and good internal consistency (Cronbach alphas: .86 and .70, respectively). In Study II, principal components analysis demonstrated that the RPSQ is a homogeneous somatization scale, but the CMCQ could be divided into 4 subscales: one for psychiatric disorders and 3 for different types of somatic disorders. Concurrent validity of the RPSQ was shown by strong correlations with the Cornell Medical Index (CMI) and the Brief Symptom Inventory-18 (BSI-18) somatization scales. The validity of CMCQ responses was not assessed. Discriminant validity was modest: the BSI-18 anxiety and depression scales were less strongly correlated with the RPSQ than the BSI-18 somatization scale. The RPSQ and CMCQ scores of IBS patients were significantly higher than the scores of healthy controls (P<.001). CONCLUSIONS: The RPSQ and CMCQ are psychometrically sound measures of somatization and medical comorbidities in IBS.

IBS patients show frequent fluctuations between loose/watery and hard/lumpy stools: implications for treatment.

OBJECTIVES: The objectives of this study were to determine how variable stool consistency is in patients with irritable bowel syndrome (IBS) and to assess the relationship between stool consistency and gastrointestinal symptoms. METHODS: Individuals with a physician diagnosis of IBS were recruited by advertisement. Enrollment questionnaires included the Rome III Diagnostic Questionnaire and IBS Symptom Severity Scale. Then, 185 patients meeting the Rome criteria for IBS rated the consistency (using the Bristol Stool Scale) of each bowel movement (BM) for 90 days and whether the BM was accompanied by pain, urgency, or soiling. Each night, they transferred BM ratings from a paper diary to an internet form and also reported the average daily intensity of abdominal pain, bloating, bowel habit dissatisfaction, and life interference of bowel symptoms. Only the longest sequence of consecutive days of diary data was used in the analysis (average of 73 days). RESULTS: Patients were 89% females with average age 36.6 years. Among the patients, 78% had both loose/watery and hard/lumpy stools; the average was three fluctuations between these extremes per month. The proportion of loose/watery stools correlated r=0.78 between the first and second months and the proportion of hard/lumpy stools correlated r=0.85 between months. Loose/watery stools were associated with more BM-related pain, urgency, and soiling than hard/lumpy or normal stools; however, IBS-C patients had significantly more BM-unrelated abdominal pain, bloating, dissatisfaction with bowel habits, and life interference than IBS-D patients. Questionnaires overestimated the frequency of abnormal stool consistency and gastrointestinal symptoms compared with diaries. CONCLUSIONS: Stool consistency varies greatly within individuals. However, stool patterns are stable within an individual from month to month. The paradoxical findings of greater symptom severity after individual loose/watery BMs vs. greater overall symptom severity in IBS-C implies different physiological mechanisms for symptoms in constipation compared with diarrhea. Daily symptom monitoring is more sensitive and reliable than a questionnaire.

Inability of the Rome III criteria to distinguish functional constipation from constipation-subtype irritable bowel syndrome.

OBJECTIVES: The Rome III classification system treats functional constipation (FC) and irritable bowel syndrome with constipation (IBS-C) as distinct disorders, but this distinction appears artificial, and the same drugs are used to treat both. This study's hypothesis is that FC and IBS-C defined by Rome III are not distinct entities. METHODS: In all, 1,100 adults with a primary care visit for constipation and 1,700 age- and gender-matched controls from a health maintenance organization completed surveys 12 months apart; 66.2% returned the first questionnaire. Rome III criteria identified 231 with FC and 201 with IBS-C. The second survey was completed by 195 of the FC and 141 of the IBS-C cohorts. Both surveys assessed the severity of constipation and IBS, quality of life (QOL), and psychological distress. RESULTS: (i) Overlap: if the Rome III requirement that patients meeting criteria for IBS cannot be diagnosed with FC is suspended, 89.5% of IBS-C cases meet criteria for FC and 43.8% of FC patients fulfill criteria for IBS-C. (ii) No qualitative differences between FC and IBS-C: 44.8% of FC patients report abdominal pain, and paradoxically IBS-C patients have more constipation symptoms than FC. (iii) Switching between diagnoses: by 12 months, 1/3 of FC transition to IBS-C and 1/3 of IBS-C change to FC. CONCLUSIONS: Patients identified by Rome III criteria for FC and IBS-C are not distinct groups. Revisions to the Rome III criteria, possibly including incorporation of physiological tests of transit and pelvic floor function, are needed.

Survey of geriatricians on the effect of fecal incontinence on nursing home referral.

OBJECTIVES: Determine the effect of fecal incontinence (FI) on healthcare providers' decisions to refer patients for nursing home (NH) placement. DESIGN: Survey. SETTING: Questionnaires were e-mailed to participants' homes or offices. Participants could also volunteer at the 2008 American Geriatric Society annual meeting in Washington, DC. PARTICIPANTS: Two thousand randomly selected physician members and all 181 nurse practitioner members of the American Geriatrics Society were surveyed. MEASUREMENTS: The survey presented a clinical scenario of a 70-year-old woman ready for discharge from a hospital and asked about the likelihood of making a NH referral if the patient had no incontinence, urinary incontinence (UI) alone, or FI. Subsequent questions modified the clinical situation to include other conditions that might affect the decision to refer. A second survey of respondents to Survey 1 addressed possible moderators of the decision to refer (e.g., family caregiver presence, diarrhea or constipation, other physical or psychiatric limitations). Significance of differences in the relative risk (RR) for NH referral was tested using the chi-square test. RESULTS: Seven hundred sixteen members (24.7% response rate) completed the first survey, and 686 of the 716 (96%) completed the second. FI increased the likelihood of NH referral (RR=4.71, P<.001) more than UI did (RR=1.90, P<.001). Mobility restrictions, cognitive decline, and multiple chronic illnesses increased the likelihood of NH referral more than FI alone (P<.001 for each), but in all scenarios, adding FI further increased the likelihood of referral (P<.001). Having family caregivers willing to help with toileting attenuated the likelihood of referral. CONCLUSION: FI increases the probability that geriatricians will refer to a NH. More-aggressive outpatient treatment of FI might delay or prevent NH referral, improve quality of life, and reduce healthcare costs.

Fecal incontinence in primary care: prevalence, diagnosis, and health care utilization.

OBJECTIVE: We sought to estimate the frequency of self-reported fecal incontinence (FI), identify what proportion of these patients have a diagnosis of FI in their medical record, and compare health care costs and utilization in patients with different severities of FI to those without FI. STUDY DESIGN: Patients in a health maintenance organization were eligible and 1707 completed a survey. Patients with self-reported FI were assessed for a diagnosis of FI in their medical record for the last 5 years. Health care costs and utilization were obtained from claims data. RESULTS: FI was reported by 36.2% of primary care patients, but only 2.7% of patients with FI had a medical diagnosis. FI adversely affected quality of life and severe FI was associated with 55% higher health care costs (including 77% higher gastrointestinal-related health care costs) compared to continent patients. CONCLUSION: Increased screening of FI is needed.

Audio-recorded guided imagery treatment reduces functional abdominal pain in children: a pilot study.

OBJECTIVE: This study was designed to develop and to test a home-based, guided imagery treatment protocol, using audio and video recordings, that is easy for health care professionals and patients to use, is inexpensive, and is applicable to a wide range of health care settings. METHODS: Thirty-four children, 6 to 15 years of age, with a physician diagnosis of functional abdominal pain were assigned randomly to receive 2 months of standard medical care with or without home-based, guided imagery treatment. Children who received only standard medical care initially received guided imagery treatment after 2 months. Children were monitored for 6 months after completion of guided imagery treatment. RESULTS: All treatment materials were reported to be self-explanatory, enjoyable, and easy to understand and to use. The compliance rate was 98.5%. In an intention-to-treat analysis, 63.1% of children in the guided imagery treatment group were treatment responders, compared with 26.7% in the standard medical care-only group (P = .03; number needed to treat: 3). Per-protocol analysis showed similar results (73.3% vs 28.6% responders). When the children in the standard medical care group also received guided imagery treatment, 61.5% became treatment responders. Treatment effects were maintained for 6 months (62.5% responders). CONCLUSION: Guided imagery treatment plus medical care was superior to standard medical care only for the treatment of abdominal pain, and treatment effects were sustained over a long period.

Contributions of pain sensitivity and colonic motility to IBS symptom severity and predominant bowel habits.

OBJECTIVES: Irritable bowel syndrome (IBS) patients show pain hypersensitivity and hypercontractility in response to colonic or rectal distention. Aims were to determine whether predominant bowel habits and IBS symptom severity are related to pain sensitivity, colon motility, or smooth muscle tone. METHODS: One hundred twenty-nine patients classified as IBS with diarrhea (IBS-D, N = 44), IBS with constipation (IBS-C, N = 29), mixed IBS (IBS-M, N = 45), and unspecified IBS (IBS-U, N = 11) based on stool consistency, and 30 healthy controls (HC) were studied. A manometric catheter containing a 600-mL capacity plastic bag was positioned in the descending colon. Pain threshold was assessed using a barostat. Motility was assessed for 10 min with the bag minimally inflated (individual operating pressure [IOP]), 10 min at 20 mmHg above the IOP, and for 15-min recovery following bag inflation. Motility was also recorded for 30 min following an 810-kcal meal. RESULTS: Compared with HC, IBS patients had lower pain thresholds (medians 30 vs 40 mmHg, P < 0.01), but IBS subtypes were not different. IBS symptom severity was correlated with pain thresholds (rho =-0.36, P < 0.001). During distention, the motility index (MI) was significantly higher in IBS compared with HC (909 +/- 73 vs 563 +/- 78, P < 0.01). Average barostat bag volume at baseline was higher (muscle tone lower) in HC compared with IBS-D and IBS-M but not compared with IBS-C. The baseline MI and bag volume differed between IBS-D and IBS-C and correlated with symptoms of abdominal distention and dissatisfaction with bowel movements. Pain thresholds and MI during distention were uncorrelated. CONCLUSIONS: Pain sensitivity and colon motility are independent factors contributing to IBS symptoms. Treatment may need to address both, and to be specific to predominant bowel habit.

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.

Comorbidity in irritable bowel syndrome.

BACKGROUND: Comorbid nongastrointestinal symptoms account for two-thirds of excess health-care costs in irritable bowel syndrome (IBS). OBJECTIVES: To determine whether IBS patients are at greater risk for specific comorbid disorders versus showing a general tendency to overreport symptoms; whether patients with inflammatory bowel disease (IBD) show patterns of comorbidity similar to IBS; whether comorbidity is explained by psychiatric disease; and whether excess comorbidity occurs in all IBS patients. METHODS: All 3,153 patients in a health maintenance organization with a diagnosis of IBS in 1994-1995 were compared to 3,153 age- and gender-matched controls, and to 571 IBD patients. All diagnoses in a 4-yr period beginning 1 yr before their index visit were categorized as gastrointestinal, psychiatric, or nongastrointestinal somatic. Nongastrointestinal somatic diagnoses were further divided into symptom-based versus biological marker-based diagnoses. RESULTS: Forty-eight of 51 symptom-based and 16 of 25 biomarker-based diagnoses were significantly more common in IBS versus controls. However, there were no unique associations. Bacterial, viral, and fungal infections and stroke were among diagnoses made more frequently in IBS. IBD patients were similar to controls. Greater somatic comorbidity was associated with concurrent psychiatric diagnosis. Only 16% of IBS patients had abnormally high numbers of comorbid diagnoses. CONCLUSIONS: Comorbidity in IBS is due to a general amplification of symptom reporting and physician consultation rather than a few unique associations; this suggests biased symptom perception rather than shared pathophysiology. Comorbidity is influenced by, but is not explained by, psychiatric illness. Excess comorbidity is present in only a subset of IBS patients.

Reports of "satisfactory relief" by IBS patients receiving usual medical care are confounded by baseline symptom severity and do not accurately reflect symptom improvement.

BACKGROUND: Treatment trials for irritable bowel syndrome (IBS) usually define a responder as a patient who reports satisfactory relief or adequate relief of symptoms at the end of the trial. However, these measures have not been adequately validated. AIMS: (1) Compare a binary satisfactory relief measure to alternative ways of defining a treatment responder. (2) Determine whether baseline IBS symptom severity or psychological distress influence the sensitivity of these outcome measures. METHODS: A total of 350 patients (81% females, average age 50 yr) who had a medical diagnosis of IBS and satisfied Rome II criteria, were recruited from Group Health Cooperative of Puget Sound. At baseline the Irritable Bowel Severity Scale (IBSS) was used to assess symptom severity and to classify patients as mild, moderate, or severe. Psychological distress and IBS-specific quality of life (IBS-QOL) were also assessed. After 6 months treatment with standard medical care, IBSS and IBS-QOL were reassessed, and patients were asked whether they had experienced satisfactory relief and whether they were somewhat or markedly better. RESULTS: Initial severity of IBS significantly affected the proportion who reported satisfactory relief (mild, 72%; moderate, 53%; severe, 44%) and the proportion who were somewhat or markedly better (mild, 62%; moderate, 44%; severe, 38%), but did not affect the proportion with a 50% reduction in symptoms (mild, 26%; moderate, 25%; severe, 23%). Although mild patients were the most likely to report satisfactory relief, they showed no average decrease in symptom severity or improvement in IBS-QOL. Conversely, severe patients, who were the least likely to report satisfactory relief, had the largest reductions in IBS symptom severity and the largest improvements in IBS-QOL. Psychological distress had no significant effect on the responder rate after adjusting for IBS symptom severity. CONCLUSIONS: These data from a descriptive study suggest that satisfactory relief is confounded with initial IBS symptom severity and is poorly correlated with the amount of symptom improvement. Confirmation of these findings in a clinical trial is needed.