Risk Factors for Abdominal Pain-Related Disorders of Gut-Brain Interaction in Adults and Children: A Systematic Review.

BACKGROUND & AIMS: Many studies have assessed risk factors of irritable bowel syndrome (IBS) and other abdominal pain-related disorders of gut-brain interaction (AP-DGBI); however, the role of these factors is unclear due to heterogeneous study designs. The aim of this systematic review was to extensively evaluate the literature and determine clinical risk and protective factors for the presence and persistence of AP-DGBI in children and adults. METHODS: A PubMed search identified studies investigating potential risk and protective factors for AP-DGBI in adults and children. Inclusion criteria included fully published studies with a control group; exclusion criteria included poor-quality studies (using a validated scale). For each factor, the proportion of studies that found the factor to be a risk factor, protective factor, or neither was summarized. The number of studies, diagnostic criteria, number of subjects, and average study quality rating provided further context. Whenever possible, a meta-analysis generated pooled odds ratios or mean difference. RESULTS: The systematic review included 348 studies. Female sex, gastroenteritis, abuse, stress, psychological disorders, somatic symptoms, and poor sleep were consistent risk factors for developing AP-DGBI in adults and children. In adults, additional risk factors included obesity, smoking, and increased use of medical resources. Protective AP-DGBI factors in adults included social support and optimism; no studies for protective factors were found for children. CONCLUSIONS: There are multiple risk factors for AP-DGBI in adults and children. These include female sex, gastroenteritis, abuse, stress, poor sleep, obesity, psychological disorders, and somatic symptoms. Additional studies are needed in children, on protective factors, and on factors associated with persistence of AP-DGBI.

Age Differences in Core Symptoms and Symptom Relationships in Patients With Irritable Bowel Syndrome: A Network Analysis.

INTRODUCTION: Irritable bowel syndrome (IBS) is a common disorder of gut-brain interaction, characterized by symptoms of abdominal pain and changes in bowel habits. It often co-occurs with extraintestinal somatic and psychological symptoms. However, the nature of the interrelationships among these symptoms is unclear. Although previous studies have noted age differences in IBS prevalence and specific symptom severity, it remains unknown whether specific symptoms and symptom relationships may differ by age. METHODS: Symptom data were collected in 355 adults with IBS (mean age 41.4 years, 86.2% female). Network analysis was used to examine the interrelationships among 28 symptoms and to identify the core symptoms driving the symptom structure between young (≤45 years) vs older (>45 years) adults with IBS. We evaluated 3 network properties between the 2 age groups: network structure, edge (connection) strength, and global strength. RESULTS: In both age groups, fatigue was the top core symptom. Anxiety was a second core symptom in the younger age group, but not the older age group. Intestinal gas and/or bloating symptoms also exerted considerable influences in both age groups. The overall symptom structure and connectivity were found to be similar regardless of age. DISCUSSION: Network analysis suggests fatigue is a critical target for symptom management in adults with IBS, regardless of age. Comorbid anxiety is likely an important treatment focus for young adults with IBS. Rome V criteria update could consider the importance of intestinal gas and bloating symptoms. Additional replication with larger diverse IBS cohorts is warranted to verify our results.

Symptom management needs of patients with irritable bowel syndrome and concurrent anxiety and/or depression: A qualitative study.

AIMS: To understand the experiences and needs of symptom management among individuals with irritable bowel syndrome and concurrent symptoms of anxiety and/or depression. DESIGN: This study used a qualitative descriptive research design. METHODS: Individuals with a diagnosis of irritable bowel syndrome and concurrent symptoms of anxiety and/or depression participated were recruited through an online ResearchMatch and a listserv. Semi-structured interviews focused on symptoms and experiences with symptom management interventions conducted from June to August 2020. Interviews were transcribed and data were analysed based on thematic analysis. RESULTS: Twelve individuals participated in this study; all reported current irritable bowel syndrome and anxiety/depression symptoms. The data analysis cumulated with three themes related to symptom management: (a) irritable bowel syndrome negatively impacts physical and mental well-being; (b) a trial and error approach to symptom management; and (c) challenges with healthcare professionals supporting symptom management including negative interactions with healthcare professionals and lack of nutritional expertize and support. CONCLUSION: There is a need for individualized approaches which consider patients' current symptoms of anxiety and depression, previous experiences with the trial-and-error process and consideration for intervention delivery methods. IMPACT: There is a limited qualitative research focusing on the experiences of individuals with irritable bowel syndrome and concurrent symptoms of anxiety and/or depression. This research highlights the need for individualized approaches to enhance symptom management that acknowledges patients' psychological state and past negative experiences with providers and prior dietary regimens.

Cyclic Vomiting Syndrome and Cannabis Hyperemesis Syndrome: The State of the Science.

This article provides a narrative review of the state of the science for both cyclic vomiting syndrome and cannabis hyperemesis syndrome along with a discussion of the relationship between these 2 conditions. The scope of this review includes the historical context of these conditions as well as the prevalence, diagnostic criteria, pathogenesis, and treatment strategies for both conditions. A synopsis of the endocannabinoid system provides a basis for the hypothesis that a lack of cannabidiol in modern high-potency Δ 9 -tetrahydrocannabinol cannabis may be contributory to cannabis hyperemesis syndrome and possibly other cannabis use disorders. In concluding assessment, though the publications addressing both adult cyclic vomiting syndrome and cannabis hyperemesis syndrome are steadily increasing overall, the state of the science supporting the treatments, prognosis, etiology, and confounding factors (including cannabis use) is of moderate quality. Much of the literature portrays these conditions separately and as such sometimes fails to account for the confounding of adult cyclic vomiting syndrome with cannabis hyperemesis syndrome. The diagnostic and therapeutic approaches are, at present, based generally on case series publications and expert opinion, with a very limited number of randomized controlled trials and a complete absence of Level 1 evidence within the cyclic vomiting literature overall as well as for cannabis hyperemesis syndrome specifically.

Impact of COVID-19 on Individuals With Irritable Bowel Syndrome and Comorbid Anxiety and/or Depression.

GOALS: The goal of this study was to describe the influence of the COVID-19 pandemic on ability to engage in activities and the influence on psychological distress and gastrointestinal symptoms among individuals with irritable bowel syndrome (IBS) and comorbid anxiety and/or depression. BACKGROUND: Individuals with IBS and comorbid anxiety and/or depression report increased symptoms and decreased quality of life compared with individuals with IBS alone. The current COVID-19 pandemic has the potential to further influence symptoms among individuals with IBS and comorbid anxiety and/or depression. STUDY: Individuals who met the Rome-IV IBS criteria and reported mild to severe anxiety and/or depression were included. Participants completed an online survey with questions about anxiety, depression, impact of COVID on activities and symptoms, and demographics. RESULTS: Fifty-five individuals participated in the study. The COVID-19 pandemic most commonly influenced their ability to spend time with friends and family, shop for certain types of food, and access health care. Participants also reported increased stress (92%), anxiety (81%), and depressive symptoms (67%). Finally, around half the sample reported increases in abdominal pain (48%), diarrhea (45%), or constipation (44%). CONCLUSIONS: The COVID-19 pandemic is related to self-reported increases in psychological distress and gastrointestinal symptoms among individuals with IBS and comorbid anxiety and/or depression. Additional research is needed to intervene on these symptoms.

Hypnosis and relaxation interventions for chronic pain management in cancer survivors: a randomized controlled trial.

PURPOSE: Nonpharmacological interventions such as hypnosis show promising evidence for the self-management of pain and pain-related sequelae among cancer survivors. The purpose of this study was to evaluate the efficacy of a 4-week recorded hypnosis intervention in reducing pain intensity compared to a recorded relaxation intervention in cancer survivors with chronic pain. METHODS: Adult cancer survivors were randomly assigned to listen to hypnosis (n = 55) or relaxation recordings (n = 54) daily for 28 days. Primary (pain intensity) and secondary outcomes (pain interference, anxiety, depression, fatigue, sleep disturbance) measures were completed pre- and post-treatment. Treatment effects were evaluated using a series of analyses of covariance. RESULTS: Both hypnosis and relaxation provided significant and moderate to large improvements in the primary outcome and the secondary outcomes of pain interference and anxiety (ds = 0.44-0.88). The hypnosis group also experienced a moderate improvement in fatigue (d = 0.47) and sleep disturbance (d = 0.54). The effect size for pain reduction from pre- to post-treatment for the hypnosis group was d = 0.86 and for the relaxation group, d = 0.88. There were no significant between-group differences in primary and secondary outcomes from pre- to post-treatment. CONCLUSIONS: The results support that recorded hypnosis and relaxation interventions are similarly effective in reducing pain and the pain-related sequelae of pain interference and anxiety among cancer survivors with chronic pain. The hypnosis intervention also reduced fatigue and sleep disturbance. Audio recordings can provide a convenient delivery method of nonpharmacological interventions to self-manage chronic pain. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03867760, registered March 8, 2019.

Delivery Methods of Cognitive Behavior Therapy for Patients With Irritable Bowel Syndrome.

Irritable bowel syndrome (IBS) is the most commonly diagnosed gastrointestinal disorder and negatively impacts individuals' quality of life. Cognitive behavioral therapy appears effective for reducing symptoms in many irritable bowel syndrome patients. However, the optimal methods to deliver cognitive behavioral therapy and the effective treatment dosage for patients with IBS remain unclear. This article aims to provide an update on cognitive behavioral therapy research in IBS, particularly considering the dose of treatment, route of delivery (in-person vs. web- and telephone-based delivery), and outcome measures. A systematic literature review was conducted using databases of PubMed, CINAHL Complete, and Web of Science from 2008 through 2021. Twelve studies reporting randomized clinical trials comparing cognitive behavioral therapy delivered with in-person, telephone, and web for the management of IBS symptoms among adults with irritable bowel syndrome were found. The dose of treatment varied from 4 to 10 sessions. Six different scales measured various outcomes. No severe adverse reactions to cognitive behavioral therapy were reported. Cognitive behavioral therapy is an effective treatment for IBS symptoms regardless of the dose and the route of treatment. However, it is difficult to compare the effectiveness of these randomized clinical trials due to the various cognitive behavioral therapy protocols, combined routes of therapy delivery, and different outcome measures used.

Early Evidence Indicates Vitamin D Improves Symptoms of Irritable Bowel Syndrome: Nursing Implications and Future Research Opportunities.

Irritable bowel syndrome (IBS) affects approximately 11.2% of the population. Yet, full understanding of its etiology and optimal treatment remains elusive. Understanding of the underlying pathophysiology of IBS has been limited. However, research is beginning to identify the cause as multifactorial (e.g., low-grade local mucosal inflammation, systemic immune activation, altered intestinal permeability, intestinal hypersensitivity, altered central nervous system processing, changes in intestinal microbiota). Understanding of the role of vitamin D in intestinal inflammation, immunity, and gastrointestinal conditions is increasing but is not yet fully understood. Growing evidence has linked vitamin D deficiency with a variety of gastrointestinal disorders, including inflammatory bowel disease, diverticulitis, colorectal cancer, and IBS. Several studies have demonstrated that individuals with IBS are more likely to have vitamin D deficiency than healthy controls. Recent vitamin D supplementation studies have shown improvement in quality of life and reduction in IBS symptoms (including abdominal pain, distention, flatulence, constipation, and visceral sensitivity) but the mechanism remains unclear. Nurses are well positioned to educate patients about the importance of sufficient vitamin D for overall health in individuals with IBS as well as participate in well-designed therapeutic studies to explore whether enhanced vitamin D status will ultimately help treat IBS more effectively.

Relationships of Microbiome Markers With Extraintestinal, Psychological Distress and Gastrointestinal Symptoms, and Quality of Life in Women With Irritable Bowel Syndrome.

INTRODUCTION: Altered microbial diversity has been associated with gastrointestinal (GI) symptoms in persons with irritable bowel syndrome (IBS). Less is known about the relationship of microbiome with extraintestinal pain and psychological distress symptoms and quality of life (QOL) in persons with IBS. We aimed to evaluate the relationship of fecal microbiota to GI symptoms, stool consistency, psychological distress, extraintestinal pain, and QOL in participants meeting Rome III criteria for IBS. METHODS: Seventy-six women completed a 28-day diary that included GI, stool consistency, psychological distress, and extraintestinal pain ratings. Participants completed the IBS-Specific Quality of Life questionnaire. Stool samples were collected and analyzed by 16S rRNA gene sequencing. Principal component analysis was performed and the first 2 components (PC1, PC2) were used to test relationships among bacterial families and clinical measures. RESULTS: Participants were categorized as IBS constipation (n=22), IBS diarrhea (n=39), IBS mixed (n=13), and IBS unsubtyped (n=2). There was a significant group effect for the Firmicutes to Bacteroidetes ratio and PC1. Lower microbial diversity and richness were associated with increased urgency and extraintestinal pain, worse QOL, and looser stools. Lower extraintestinal pain was associated with increased Rikenellaceae, Christensenellaceae, Dehalobabacteriaceae, Oscillospiraceae, Mogibacteriaceae, Ruminococcaceae, Sutterellaceae, Desulfovibrionaceae, and Erysipelotrichaceae abundances. QOL was positively associated with many of these same bacterial families. Higher Firmicutes to Bacteroidetes ratio was positively associated with loose stools. There were no statistically significant relationships between daily psychological distress or abdominal pain and bacterial families. CONCLUSIONS: Stool microbial diversity and composition are linked to daily extraintestinal symptoms, stool consistency, and QOL in women with IBS.

Relationships Between Abdominal Pain and Fatigue With Psychological Distress as a Mediator in Women With Irritable Bowel Syndrome.

Women with irritable bowel syndrome often report fatigue, along with abdominal pain and psychological distress (i.e., depression and anxiety). There is little information about the relationships among these symptoms. Using a secondary data analysis (N = 356), we examined the relationship between abdominal pain and fatigue and whether psychological distress mediates the effect of abdominal pain on fatigue in both across women and within woman with irritable bowel syndrome. Data gathered through a 28-day diary were analyzed with linear regressions. The across-women and within-woman relationships among same-day abdominal pain, fatigue, and psychological distress were examined. Within-woman relationships were also examined for directionality among symptoms (i.e., prior-day abdominal pain predicts next-day fatigue and prior-day fatigue predicts next-day abdominal pain). In across-women and within-woman analyses on the same day, abdominal pain and fatigue were positively correlated. In within-woman analyses, abdominal pain predicted next-day fatigue, but fatigue did not predict next-day pain. In across-women and within-woman analyses, psychological distress partially mediated the effects of abdominal pain on fatigue. Symptom management incorporating strategies to decrease both abdominal pain and psychological distress are likely to reduce fatigue. Nursing interventions, such as self-management skills to reduce abdominal pain and psychological distress, may have the added benefit of reducing fatigue in irritable bowel syndrome.

The Use of Technology to Support Precision Health in Nursing Science.

PURPOSE: This article outlines how current nursing research can utilize technology to advance symptom and self-management science for precision health and provides a roadmap for the development and use of technologies designed for this purpose. APPROACH: At the 2018 annual conference of the National Institute of Nursing Research (NINR) Research Centers, nursing and interdisciplinary scientists discussed the use of technology to support precision health in nursing research projects and programs of study. Key themes derived from the presentations and discussion were summarized to create a proposed roadmap for advancement of technologies to support health and well-being. CONCLUSIONS: Technology to support precision health must be centered on the user and designed to be desirable, feasible, and viable. The proposed roadmap is composed of five iterative steps for the development, testing, and implementation of technology-based/enhanced self-management interventions. These steps are (a) contextual inquiry, focused on the relationships among humans, and the tools and equipment used in day-to-day life; (b) value specification, translating end-user values into end-user requirements; (c) design, verifying that the technology/device can be created and developing the prototype(s); (d) operationalization, testing the intervention in a real-world setting; and (e) summative evaluation, collecting and analyzing viability metrics, including process data, to evaluate whether the technology and the intervention have the desired effect. CLINICAL RELEVANCE: Interventions using technology are increasingly popular in precision health. Use of a standard multistep process for the development and testing of technology is essential.

Symptom-based latent classes of persons with irritable bowel syndrome.

A large amount of interindividual variability exists in symptom experiences of persons with irritable bowel syndrome (IBS). Thus, consideration of multiple symptoms to identify distinct symptom subgroups may be useful in directing personalized health strategies for symptom management. We aimed to identify latent classes (i.e., subgroups) of persons with IBS who share similar patterns of symptoms using symptom-related variables (six groups of daily diary symptoms, cognitive beliefs about IBS, and IBS quality of life [QOL]); and to examine how subgroups differed in patient characteristics. Data were derived from a baseline assessment of men and women enrolled in two cognitively-focused intervention trials (N = 332). Using latent class analysis, four latent classes were identified: Class 1 (low symptoms and good QOL, n = 153), Class 2 (low symptoms and moderate QOL, n = 106), Class 3 (high symptoms with diarrhea and poor QOL, n = 38), and Class 4 (high symptoms with low diarrhea and moderate QOL, n = 35). Diarrhea, being female, less formal education, unemployment, and previous history of major depressive disorder were associated with membership in Class 3. Using these distinct symptom profiles, the next step is to explore underlying mechanisms accounting for symptom burden with the goal of designing tailored interventions to reduce that burden.

Precision health: Advancing symptom and self-management science.

BACKGROUND: Precision health considers individual lifestyle, genetics, behaviors, and environment context and facilitates interventions aimed at helping individuals achieve well-being and optimal health. PURPOSE: To present the Nursing Science Precision Health (NSPH) Model and describe the integration of precision health concepts within the domains of symptom and self-management science as reflected in the National Institute of Nursing Research P30 Centers of Excellence and P20 Exploratory Centers. METHODS: Center members developed the NSPH Model and the manuscript based on presentations and discussions at the annual NINR Center Directors Meeting and in follow-up telephone meetings. DISCUSSION: The NSPH Model comprises four precision components (measurement; characterization of phenotype including lifestyle and environment; characterization of genotype and other biomarkers; and intervention target discovery, design, and delivery) that are underpinned by an information and data science infrastructure. CONCLUSION: Nurse scientist leadership is necessary to realize the vision of precision health as reflected in the NSPH Model.

Effects of Low-FODMAPS Diet on Irritable Bowel Syndrome Symptoms and Gut Microbiome.

Patients with irritable bowel syndrome (IBS) suffer from abdominal pain, bloating, and abnormal defecation. Reducing the dietary intake of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) has been shown to be beneficial in reducing IBS symptoms. However, diet modification plays an important role in the composition of colonic microbiota. Currently, the effects of a FODMAP diet on the composition of the gut microbiome are not known. We conducted a systematic review to determine (1) the effectiveness of low-FODMAPs diet to reduce symptoms of patients with IBS and (2) the association between a low-FOMAPs diet and the composition of gut microbiome. Four electronic databases were searched using key words "IBS" or "irritable bowel syndrome," and "FODMAP" or "FODMAPs" or "fermentable oligosaccharides, disaccharides, monosaccharides, and polyols," and "microbiome." Two reviewers (H.S. and Y.T.L.) selected and reviewed articles according to our inclusion criteria. A total of 87 articles were reviewed and 7 met inclusion criteria. Based on the systematic review, low FODMAPs appear to reduce gastrointestinal symptoms for a least a subset of patients with IBS. However, due to the heterogeneity of reviewed studies, the influence on patients' gut microbiome composition and/or microbiota metabolites requires additional studies.

Symptom Comparisons Between Asian American and White American Women With Irritable Bowel Syndrome.

There is little information on racial/ethnic characteristics of patients with irritable bowel syndrome. In this study, we determined whether the severity of symptoms (gastrointestinal, psychological distress), cognitive beliefs about irritable bowel syndrome, and life impacts (life interference, health-related quality of life) differ between Asian American and White American women with irritable bowel syndrome. We also look at the relationships among these variables. Asian American women (N = 21) and age- and design-matched White American women (N = 63) with irritable bowel syndrome were included. Data were collected from questionnaires and a 28-day daily diary (e.g., abdominal pain, depression). The percent of days with moderate/severe abdominal pain and psychological distress were significantly higher, and constipation- and diarrhea-dominant bowel pattern subtypes were prevalent in White Americans as compared with Asian Americans. Positive relationships of gastrointestinal symptoms with psychological distress, and of gastrointestinal and psychological symptoms with negative cognitive beliefs and negative life impact, were observed in White Americans. Further studies to evaluate contributing (e.g., cultural-environmental, pathophysiological, diet) factors of symptom characteristics in Asian Americans are suggested. Our study provides useful information for healthcare providers to understand symptoms and cultural factors and the potential for culturally tailored symptom management for this patient group.

Effectiveness of Probiotic, Prebiotic, and Synbiotic Therapies in Reducing Postoperative Complications: A Systematic Review and Network Meta-analysis.

BACKGROUND: Microbiome-directed therapies are increasingly used preoperatively and postoperatively to improve postoperative outcomes. Recently, the effectiveness of probiotics, prebiotics, and synbiotics in reducing postoperative complications (POCs) has been questioned. This systematic review aimed to examine and rank the effectiveness of these therapies on POCs in adult surgical patients. METHODS: We searched for articles from PubMed, Embase, Cochrane, Web of Science, Scopus, and CINAHL plus. From 2002 to 2015, 31 articles meeting the inclusion criteria were identified in the literature. Risk of bias and heterogeneity were assessed. Network meta-analyses (NMA) were performed using random-effects modeling to obtain estimates for study outcomes. Risk ratios (RRs) and 95% confidence intervals (CIs) were estimated. We then ranked the comparative effects of all regimens with the surface under the cumulative ranking (SUCRA) probabilities. RESULTS: A total of 2,952 patients were included. We found that synbiotic therapy was the best regimen in reducing surgical site infection (SSI) (RR = 0.28; 95% CI, 0.12-0.64) in adult surgical patients. Synbiotic therapy was also the best intervention to reduce pneumonia (RR = 0.28; 95% CI, 0.09-0.90), sepsis (RR = 0.09; 95% CI, 0.01-0.94), hospital stay (mean = 9.66 days, 95% CI, 7.60-11.72), and duration of antibiotic administration (mean = 5.61 days, 95% CI, 3.19-8.02). No regimen significantly reduced mortality. CONCLUSIONS: This network meta-analysis suggests that synbiotic therapy is the first rank to reduce SSI, pneumonia, sepsis, hospital stay, and antibiotic use. Surgeons should consider the use of synbiotics as an adjunctive therapy to prevent POCs among adult surgical patients. Increasing use of synbiotics may help to reduce the use of antibiotics and multidrug resistance.

COMT Val158Met Polymorphism and Symptom Improvement Following a Cognitively Focused Intervention for Irritable Bowel Syndrome.

BACKGROUND: Our nurse-delivered comprehensive self-management (CSM) program, a cognitive behavioral therapy intervention, is effective in reducing gastrointestinal and psychological distress symptoms in patients with irritable bowel syndrome (IBS). Findings from non-IBS studies indicate that the catechol-O-methyltransferase (COMT) Val158Met polymorphism may moderate the efficacy of cognitive behavioral therapy. It is unknown whether this COMT polymorphism is associated with symptom improvements in patients with IBS. OBJECTIVE: We tested whether this COMT Val158Met polymorphism influences the efficacy of our 2-month CSM intervention. METHODS: We analyzed data from two published randomized controlled trials of CSM. The combined European American sample included 149 women and 23 men with IBS (CSM, n = 111; usual care [UC], n = 61). The primary outcomes were daily reports of abdominal pain, depression, anxiety, and feeling stressed measured 3 and 6 months after randomization. Secondary outcomes were additional daily symptoms, retrospective psychological distress, IBS quality of life, and cognitive beliefs about IBS. The interaction between COMT Val158Met polymorphism and treatment group (CSM vs. UC) in a generalized estimating equation model tested the main objective. RESULTS: At 3 months, participants with at least one Val allele benefited more from CSM than did those with the Met/Met genotype (p = .01 for anxiety and feeling stressed, and p < .16 for abdominal pain and depression). The moderating effect of genotype was weaker at 6 months. DISCUSSION: Persons with at least one Val allele may benefit more from CSM than those homozygous for the Met allele. Future studies with larger and more racially diverse samples are needed to confirm these findings. RCT REGISTRATION: Parent studies were registered at ClinicalTrials.gov (NCT00167635 and NCT00907790).

Feasibility of Combining Common Data Elements Across Studies to Test a Hypothesis.

PURPOSE: The purpose of this article is to describe the outcomes of a collaborative initiative to share data across five schools of nursing in order to evaluate the feasibility of collecting common data elements (CDEs) and developing a common data repository to test hypotheses of interest to nursing scientists. This initiative extended work already completed by the National Institute of Nursing Research CDE Working Group that successfully identified CDEs related to symptoms and self-management, with the goal of supporting more complex, reproducible, and patient-focused research. DESIGN: Two exemplars describing the group's efforts are presented. The first highlights a pilot study wherein data sets from various studies by the represented schools were collected retrospectively, and merging of the CDEs was attempted. The second exemplar describes the methods and results of an initiative at one school that utilized a prospective design for the collection and merging of CDEs. METHODS: Methods for identifying a common symptom to be studied across schools and for collecting the data dictionaries for the related data elements are presented for the first exemplar. The processes for defining and comparing the concepts and acceptable values, and for evaluating the potential to combine and compare the data elements are also described. Presented next are the steps undertaken in the second exemplar to prospectively identify CDEs and establish the data dictionaries. Methods for common measurement and analysis strategies are included. FINDINGS: Findings from the first exemplar indicated that without plans in place a priori to ensure the ability to combine and compare data from disparate sources, doing so retrospectively may not be possible, and as a result hypothesis testing across studies may be prohibited. Findings from the second exemplar, however, indicated that a plan developed prospectively to combine and compare data sets is feasible and conducive to merged hypothesis testing. CONCLUSIONS: Although challenges exist in combining CDEs across studies into a common data repository, a prospective, well-designed protocol for identifying, coding, and comparing CDEs is feasible and supports the development of a common data repository and the testing of important hypotheses to advance nursing science. CLINICAL RELEVANCE: Incorporating CDEs across studies will increase sample size and improve data validity, reliability, transparency, and reproducibility, all of which will increase the scientific rigor of the study and the likelihood of impacting clinical practice and patient care.

The Gastrointestinal Pain Pointer: A Valid and Innovative Method to Assess Gastrointestinal Symptoms.

Abdominal pain is a chronic condition experienced by approximately 20% of individuals in the United States. The purpose of the study was to assess the validity of the Gastrointestinal Pain Pointer as a measure of abdominal pain intensity. A prospective longitudinal time-series study design was utilized. The sample included 93 outpatients (58.1% female). Participants met Rome III criteria for irritable bowel syndrome (n = 32) or were healthy controls (n = 61). The Gastrointestinal Pain Pointer, a new electronic pain assessment tool, was used to assess self-reported abdominal pain intensity among participants before and after ingestion of an intestinal permeability test solution across 11 time points over a 5-hour time period. The results were compared with the Short-Form McGill Pain Questionnaire. The Gastrointestinal Pain Pointer was found to be valid in the assessment of abdominal pain intensity. The tool is a novel and valid measure of abdominal pain intensity that enhances the ability for clinicians to better quantify, in real time, patient-related pain outcomes for both clinical care and research.

A Comprehensive Self-Management Irritable Bowel Syndrome Program Produces Sustainable Changes in Behavior After 1 Year.

BACKGROUND & AIMS: We developed a comprehensive self-management (CSM) program that combines cognitive behavioral therapy with relaxation and dietary strategies; 9 sessions (1 hour each) over 13 weeks were shown to reduce gastrointestinal symptoms and increase quality of life in a randomized trial of patients with irritable bowel syndrome (IBS), compared with usual care. The aims of this study were to describe strategies patients with IBS selected and continued to use, 12 months after the CSM program began. METHODS: We performed a cohort study to continue to follow 81 adults with IBS (87% female; mean age, 45 ± 15 years old) who received the CSM program in the previous clinical trial. During the last CSM session, participants selected strategies they intended to continue using to manage their IBS. CSM strategies were categorized into subthemes of diet (composition, trigger foods, meal size or timing, and eating behaviors), relaxation (specific relaxation strategies and lifestyle behaviors), and alternative thoughts (identifying thought distortions, challenging underlying beliefs, and other strategies). Twelve months later, participants were asked how often they used each strategy (not at all or rarely, occasionally, often, very often, or almost always). RESULTS: At the last CSM session, 95% of the patients selected the subthemes of specific relaxation strategies, 90% selected diet composition, and 90% identified thought distortions for continued use. At 12 months, 94% of the participants (76 of 81) were still using at least 6 strategies, and adherence was greater than 79% for all subthemes. CONCLUSIONS: We developed a CSM program to reduce symptoms and increase quality of life in patients with IBS that produced sustainable behavioral changes in almost all patients (94%) after 1 year of follow-up.