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Background & Aims: Colorectal cancer (CRC) screening guidelines include screening colonoscopy and sequential high-sensitivity fecal occult blood testing (HSgFOBT), with expectation of similar effectiveness based on the assumption of similar high adherence. However, adherence to screening colonoscopy compared with sequential HSgFOBT has not been reported. In this randomized clinical trial, we assessed adherence and pathology findings for a single screening colonoscopy vs sequential and nonsequential HSgFOBTs. Methods: Participants aged 40–69 years were enrolled at 3 centers representing different clinical settings. Participants were randomized into a single screening colonoscopy arm vs sequential HSgFOBT arm composed of 4–7 rounds. Initial adherence to screening colonoscopy and sequential adherence to HSgFOBT, follow-up colonoscopy for positive HSgFOBT tests, crossover to colonoscopy, and detection of advanced neoplasia or large serrated lesions (ADN-SERs) were measured. Results: There were 3523 participants included in the trial; 1761 and 1762 participants were randomized to the screening colonoscopy and HSgFOBT arms, respectively. Adherence was 1473 (83.6%) for the screening colonoscopy arm vs 1288 (73.1%) for the HSgFOBT arm after 1 round (relative risk [RR], 1.14; 95% CI, 1.10–1.19; P ≤.001), but only 674 (38.3%) over 4 sequential HSgFOBT rounds (RR, 2.19; 95% CI, 2.05–2.33). Overall adherence to any screening increased to 1558 (88.5%) in the screening colonoscopy arm during the entire study period and 1493 (84.7%) in the HSgFOBT arm (RR, 1.04; 95% CI, 1.02–1.07). Four hundred thirty-six participants (24.7%) crossed over to screening colonoscopy during the first 4 rounds. ADN-SERs were detected in 121 of the 1473 participants (8.2%) in the colonoscopy arm who were adherent to protocol in the first 12 months of the study, whereas detection of ADN-SERs among those who were not sequentially adherent (n = 709) to HSgFOBT was subpar (0.6%) (RR, 14.72; 95% CI, 5.46–39.67) compared with those who were sequentially adherent (3.3%) (n = 647) (RR, 2.52; 95% CI, 1.61–3.98) to HSgFOBT in the first 4 rounds. When including colonoscopies from HSgFOBT patients who were never positive yet crossed over (n = 1483), 5.5% of ADN-SERs were detected (RR, 1.50; 95% CI, 1.15–1.96) in the first 4 rounds. Conclusions: Observed adherence to sequential rounds of HSgFOBT was suboptimal compared with a single screening colonoscopy. Detection of ADN-SERs was inferior when nonsequential HSgFOBT adherence was compared with sequential adherence. However, the greatest number of ADN-SERs was detected among those who crossed over to colonoscopy and opted to receive a colonoscopy. The effectiveness of an HSgFOBT screening program may be enhanced if crossover to screening colonoscopy is permitted. ClinicalTrials.gov, Number: NCT00102011.

INTRODUCTION Health systems often emphasize technical skills to reduce iatrogenic injuries. Nontechnical skills such as clinical and communication skills are mostly overlooked or not readily retrievable from medical records. Our aim was to estimate the association of technical and nontechnical skills of endoscopists with indemnity payments to patients after endoscopic perforations. METHODS This is an observational registry-based study of closed claims against gastroenterologists involved in endoscopic perforations. RESULTS We analyzed 175 closed claims related to perforations, all of which involved allegations of improper performance of the endoscopic procedure. Inadequate communication (n = 71, 41%) and clinical judgment (n = 60, 34%) on the part of the endoscopists were observed. Inadequate communication and clinical judgment were associated with over 3-fold odds of indemnity payment (odds ratio [OR] 3.31; 95% confidence interval [CI], 1.46-7.48, and OR 3.18; 95% CI, 1.44-7.01, respectively). However, if there were no communication breakdown or clinical judgment issues and the only allegation was poor technical skill, the odds of indemnity payments were less than half of those cases (OR 0.43; 95% CI 0.15-0.80). There was no evidence of a statistically significant interaction among age, procedure type, trainee involvement, clinical severity, need for surgery, and procedure-related death. DISCUSSION We observed that inadequate communication and clinical judgment were associated with indemnity payment, independent of the severity of clinical outcomes. On the other hand, cases wherein there was an allegation of poor technical skills alone, without communication breakdown or clinical judgment issues, were associated with favorable legal outcomes for the defendant. (See the Visual Abstract at http://links.lww.com/AJG/B568.).

Objective There is a large body of evidence for the efficacy of Cognitive Behavioral Therapy (CBT) in treating Functional Abdominal Pain Disorders (FAPD) in children. In most CBT interventions for FAPD, parents participate together with their children. However, only one study to date has examined targeting parents alone for treatment. The aim of the current study was to examine mediators of a parent-only CBT treatment incorporating social learning (SLCBT) for FAPD in children. Methods We examined mediators of child outcomes in an existing randomized controlled trial (n = 316) of parent-only social learning CBT compared to an education condition. Hypothesized mediators (parental protectiveness, perceived threat of pain, catastrophizing) were assessed at 3 months post-treatment, and outcomes (parent ratings of disability, quality of life, school absences, and health care visits) were assessed at 6 months post-treatment. Mediation analyses were performed using Hayes' PROCESS macro. Results Pain catastrophizing significantly mediated treatment effects for all outcomes (B ranged from −1.65 to 2.22). Reduction in pain threat was a significant mediator for all outcomes (B ranged from −1.84 to 3.13) except school absences and health care visits. Decrease in parental protectiveness mediated effects on disability and missed school (B ranged from −1.47 to 1.34). Mediation effects did not differ by in-person or remote delivery of SLCBT. Conclusion Changes in maladaptive parental thoughts and behaviors following parent-only SLCBT intervention appeared to mediate the effects of the intervention. Parental catastrophizing appears to be a particularly important target given that decreases in that variable mediated all outcomes.

Objective To extend existing research on the pain burden experienced by youth with inflammatory bowel disease (IBD) by examining the complexity of psychosocial factors involved in pain-related distress. Methods Parents completed measures of family stress and their child's pain-related expressions of distress and coping. Youth with IBD rated their depressive symptoms (n = 183 dyads). Mediation analyses were performed using regression-based techniques and bootstrapping. Results Greater family stress was positively related to children's pain-related expressions of distress and passive coping. Significant indirect effects were found in the relationship between family stress and expressed pain-related distress through parent-reported passive coping, depressive symptoms, and both passive coping and depressive symptoms sequentially. Conclusions Results suggest that family stress can place children at risk for greater expressed pain-related distress through effects on coping and depressive symptoms. Addressing psychosocial difficulties is important for closing the gap between disability and health in youth with IBD.

This chapter concisely addresses legal aspects of gastrointestinal endoscopy. Topics discussed include legal epidemiology, basic concepts, and a description of the tort of negligence, which is the most common type of malpractice lawsuit faced by gastroenterologists. The elements of DUTY, BREACH, CAUSATION, and HARM that must be proven for the plaintiff to prevail are explained. Other topics reviewed include the role of adherence to the applicable standard of care; the use of clinical guidelines, quality measures, and expert witnesses to assess standard of care; and the importance of obtaining and documenting informed consent. The legal obligations regarding protected health information are summarized. The chapter concludes with a discussion of risk management approaches, including good documentation practices, use of clinical practice guidelines (CPGs), and best practices for managing complications and errors once they have occurred.

Pediatric functional abdominal pain disorders (FAPD) are associated with increased healthcare utilization, school absences, and poor quality of life (QoL). Cost-effective and accessible interventions are needed. This multi-site study tested the effects of a 3-session cognitive-behavioral intervention delivered to parents, in person or remotely, on the primary outcome of pain severity and secondary outcomes (process measures) of parental solicitousness, pain beliefs, catastrophizing, and child-reported coping. Additional outcomes hypothesized a priori and assessed included functional disability, quality of life, pain behavior, school absences, healthcare utilization, and gastrointestinal symptoms. The study was prospective and longitudinal (baseline, 3 and 6 months follow-up) with three randomized conditions: social learning and cognitive-behavioral therapy in-person (SLCBT) or by phone (SLCBT-R) and education/support condition by phone (ES-R). Participants were children aged 7–12 with FAPD and their parents (N = 316 dyads). While no significant treatment effect for pain severity was found, the SLCBT groups showed significantly greater improvements compared to controls on process measures of parental solicitousness, pain beliefs and catastrophizing, and additional outcomes of parent-reported functional disability, pain behaviors, child healthcare visits for abdominal pain, and (remote condition only) quality of life and missed school days. No effects were found for parent and child-reported gastrointestinal symptoms, or child-reported quality of life or coping. These findings suggest that for children with FAPD, a brief phone SLCBT for parents can be similarly effective as in-person SLCBT in changing parent responses and improving outcomes, if not reported pain and symptom report, compared to a control condition.

Background: Currently, no clinical tools use demographic and risk factor information to predict the risk of finding an adenoma in individuals undergoing colon cancer screening. Such a tool would be valuable for identifying those who would most benefit from screening colonoscopy. Methods: We used baseline data from men and women who underwent screening colonoscopy from the randomized, multicenter National Colonoscopy Study (NCS) to develop and validate an adenoma risk model. The study, conducted at three sites in the United States (Minneapolis, MN; Seattle, WA; and Shreveport, LA) asked all participants to complete baseline questionnaires on clinical risk factors and family history. Model parameters estimated from logistic regression yielded an area under the receiver operating characteristic curve (AUROCC) used to assess prediction. Results: Five hundred forty-one subjects were included in the development model, and 1,334 in the validation of the risk score. Variables in the prediction of adenoma risk for colonoscopy screening were age (likelihood ratio test for overall contribution to model, P < 0.001), male sex (P < 0.001), body mass index (P < 0.001), family history of at least one first-degree relative with colorectal cancer (P = 0.036), and smoking history (P < 0.001). The adjusted AUROCC of 0.67 [95% confidence interval (CI), 0.61–0.74] for the derivation cohort was not statistically significantly different from that in the validation cohort. The adjusted AUROCC for the entire cohort was 0.64 (95% CI, 0.60–0.67). Conclusion: We developed and validated a simple well-calibrated risk score. Impact: This tool may be useful for estimating risk of adenomas in screening eligible men and women Cancer Epidemiol Biomarkers Prev; 24(6); 913–20. ©2015 AACR.

The Affordable Care Act, passed in 2010, contained a number of regulations that directly affect physician practices, behavior, and relationships with others in the health care industry. One such provision is the “Physician Payment Sunshine Act,” which is the subject of this month’s Practice Management: The Road Ahead column. The authors have provided us with a detailed and enlightening review of how our relationships with pharmaceutical and medical device companies have become transparent and public. It will be important for you to understand this law and take the time to review your own data through CMS’s Enterprise Portal (http://www.cms.gov/Regulations-andGuidance/Legislation/National-Physician-Payment-Transp arency-Program/Physicians.html).

Throughout the past 20 years, the rising use of social media has revolutionized health care as well as other businesses. It allows large groups of people to create and share information, ideas, and experiences through online communications, and develop social and professional contacts easily and inexpensively. Our Gastroenterology organizations, among others, have embraced this technology. Although the health-care benefits may be many, social media must be viewed through a legal lens, recognizing the accompanying burdens of compliance, ethical, and litigation issues. Theories of liability and risk continue to evolve as does the technology. Social media usage within the medical community is fraught with potential legal issues, requiring remedial responses to meet patients' needs and comply with current laws, while not exposing physicians to medical malpractice and other tort risks.

Endoscopic Retrograde Cholangiopancreatography (ERCP) provides an important medical procedure for patients in a generally safe and effective manner. It can be technically complex, often performed during serious illness, and has the highest potential complication rate of procedures commonly performed by gastroenterologists. The issue of duodenoscope-related infections has been more recently added the list of potential ERCP adverse events. This chapter will take a risk management approach to help the endoscopists understand and manage the risks associated with ERCP, with particular concentration on duodenoscope related infections. This chapter is written for educational purposes only and cannot be considered legal advice. For specific legal advice, one should consult a health care attorney.

In this month's "Roadmap," Andrew Feld-MD and JD, dis­ cusses the intriguing intersection ofsocial media, the internet, and medicine. He analyzes opportunities and dangers of connectivity. Physicians who utilize social media in their medical practiw or private communications must be aware of the power and perma­ nence of electronic "footprints. !I During this year's Digestive Disease Week® AGA Spring Postgraduate Course, I moderated a session about new andpreviously unimagined resources that are being developed to monitor patients remotely, enhance our com­ munication, and allow us to "hover" over patients in need of intense physician management. This is a new world that carries awesome power and responsibility but one worth exploring.

Goals of endoscopic sedation are to provide patients with a successful procedure, and ensure that they remain safe and are relieved from anxiety and discomfort; agents should provide efficient, appropriate sedation and allow patients to recover rapidly. Sedation is usually safe and effective; however, complications may ensue. This paper outlines some medicolegal aspects of endoscopic sedation, including informed consent, possible withdrawal of consent during the procedure, standard of care for monitoring sedation, use of anesthesia personnel to deliver sedation, and new agents and devices.

Proper management of complications is critical to ensure the best outcome for both the patient and the physician. The physician's response to the error or complication, promptly informing the patient and the family, and expressing empathy at the situation, ensuring transparency and excellent post-complication care, is a critical determinant of the patient's understanding of the complication, perception of the physician, and, often, the decision to sue. Articles outlining best practice approach to various legal and risk management issues may aid physicians to acquire useful skills to help their patients.

Is the higher reported colorectal cancer (CRC) mortality in blacks versus whites in the United States due to pathology or disparities in screening? Our study used patient navigation (PN) to assist blacks and whites adhere to screening colonoscopy and compared adenomas detected in each group.

Recently, the emerging role of nonpolypoid precursors of colorectal cancer has challenged the conventional polyp-cancer sequence. The impact of colonoscopy in cancer prevention depends on its reliability in the diagnosis of colorectal neoplasia when the lesion does not extend beyond the submucosa and is potentially curable. The estimation of the risk of progression is based on the prediction of histology from the morphological appearance of the lesion and includes (1) distinction between neoplastic and non-neoplastic lesions, (2) identification of different categories of non-serrated and serrated lesions, and (3) determination of the localization in the proximal or distal colon, which has an impact on the morphology and behavior of the lesion. The pragmatic classification Of superficial neoplastic lesions proposed in this text takes into account these changes and is based oil a 2-step strategy of endoscopic diagnosis with initial detection and characterization, followed by treatment implementation, Such as endoscopic resection, ablation, and Surgery

The availability of endoscopy as a diagnostic and therapeutic tool has caused the number of procedures performed in the United States to greatly increase; additionally, the volume and complexity of endoscopic procedures performed under sedation, including difficult procedures performed on frail and severely ill patients, has increased. The goals of endoscopic sedation are to provide patients with a successful procedure and to ensure that they remain safe and are relieved from anxiety and discomfort; agents should provide efficient, appropriate sedation and allow patients to recover rapidly. Sedation is usually both safe and effective; however, complications may ensue. This article will explore medicolegal aspects of sedation, such as the importance of informed consent for sedation, the difficulties of assessing withdrawal of consent in a sedated patient, and the need for sedation monitoring which meets accepted standard of care. Controversies involving GI directed propofol and the use of anesthesia personnel to deliver sedation for endoscopy are also discussed.

Objective To assess the usefulness of health plan administrative data for identifying patients with irritable bowel syndrome (IBS). Study Design and Setting In this retrospective study of 442 medical records of patients in nine U.S. health plans, five sets of criteria that used administrative data were used to identify potential IBS patients. Physician reviewers provided an assessment of the likelihood of the diagnosis of IBS being present. IBS was considered to be present if the physician reviewer categorized the case as definite, probable, or possible based on medical record review. Analyses were also performed with cases categorized as possible placed in an “IBS not present” category. Results The positive predictive value (PPV) for the five sets of criteria ranged from 63% to 83% with the highest PPV found with one of the most restrictive criteria. When cases characterized as possible were included in the “IBS not present” category, the PPV for each of the five sets of criteria decreased substantially, ranging from 33% to 63%. Conclusion The PPV of different criteria used to identify patients with IBS from administrative data varies substantially based on the criteria that are used. Use of criteria with a higher PPV may come at the expense of generalizability.

Well-crafted systemically developed clinical practice guidelines (CPGs) are intended to frame current medical knowledge in a manner that will assist health care providers in delivering high quality care. CPGs are being used in the malpractice arena to define a credible standard of care to measure the accused physician for an alleged problem addressed. This may occur despite a medical society's disclaimer that they are not intended, nor devised, for that purpose. It can be argued that CPGs may be used with greater effect by the plaintiff's bar for inculpatory evidence than by the defense as an exculpatory standard. Physicians should be aware of the legal use of CPGs and the associated risk management implications. Physicians who write guidelines for medical societies may wish to consider the potential future courtroom use of CPGs as they attempt to use evolving research to enhance patient care. A fine line may separate a "best practice" from acceptable quality care; the former may not be expected to occur in all patient care interactions. Suggestions embedded in a CPG rather than other publication may be legally interpreted incorrectly as a baseline standard of care expectation.

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.

The use of quality improvement tools such as clinical practice guidelines and quality measures can improve patients’ clinical outcomes and reduce the incidence of adverse events. In addition to improving patient care, properly structured quality improvement policies can also reduce physician liability. If a physician is sued for malpractice, proof that the physician complied with a guideline or quality measure will help prove lack of fault for a negative outcome. However, guidelines and quality measures are double-edged swords. As quality measures and guidelines become established, courts may adopt them as de facto standards of care, and physician noncompliance may lead to liability during a malpractice trial. The careful gastroenterologist will need to keep up with quality measures both to provide good patient care and to manage risk.

Reports of “Satisfactory Relief” by IBS Patients Receiving Usual Medical Care Are Confounded by Baseline Symptom Severity and Do Not Accurately Reflect Symptom Improvement

There is little doubt that severe distortions are present in the legal adjudication of professional medical liability. The medical expert witness plays an important, often crucial, role in the medical liability cases. The expert assesses medical information, interprets and explains medical uncertainty, medical research, and customary practice for a nonscientific jury, and offers an expert level opinion as to whether the standard of medical care was met. When expert witnesses not merely disagree, but misrepresent data, misrepresent their background credentials and expertise, and offer egregiously false testimony, the legal process is violated and verdicts may be distorted. Many medical and surgical professional organizations, including the American Medical Association, have adopted programs that provide guidelines for members who serve as medical expert witnesses in professional liability cases. The American Association of Neurological Surgeons (AANS) was the first to develop a program to deal with irresponsible expert witness testimony. That program involves a published code of conduct, which outlines the expectations of society regarding expert witness testimony, and potential consequences for noncompliance. To date, the AANS program has withstood court challenge, in fact, has received judicial praise. Other medical societies, including the American College of Gastroenterology (ACG), have reviewed efforts by others and are considering developing their own programs.

Summary 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.

Proper management of complications is critical to ensure the best outcome for both the patient and the physician. The physician's response to the error or complication, promptly informing the patient and the family, and expressing empathy at the situation, ensuring transparency and excellent post-complication care, is a critical determinant of the patient's understanding of the complication, perception of the physician, and, often, the decision to sue. Articles outlining best practice approach to various legal and risk management issues may aid physicians to acquire useful skills to help their patients.

AIM: To examine familial aggregation of irritable bowel syndrome (IBS) via parental reinforcement/modeling of symptoms, coping, psychological distress, and exposure to stress. METHODS: Mothers of children between the ages of 8 and 15 years with and without IBS were identified through the Group Health Cooperative of Puget Sound. Mothers completed questionnaires, including the Child Behavior Checklist (child psychological distress), the Family Inventory of Life Events (family exposure to stress), SCL-90R (mother psychological distress), and the Pain Response Inventory (beliefs about pain). Children were interviewed separately from their parents and completed the Pain Beliefs Questionnaire (beliefs about pain), Pain Response Inventory (coping) and Child Symptom Checklist [gastrointestinal (GI) symptoms]. In addition, health care utilization data was obtained from the automated database of Group Health Cooperative. Mothers with IBS (n = 207) and their 296 children were compared to 240 control mothers and their 335 children, while controlling for age and education. RESULTS: Hypothesis 1: reinforcement of expression of GI problems is only related to GI symptoms, but not others (cold symptoms) in children. There was no significant correlation between parental reinforcement of symptoms and child expression of GI or other symptoms. Hypothesis 2: modeling of GI symptoms is related to GI but not non-GI symptom reporting in children. Children of parents with IBS reported more non-GI (8.97 vs 6.70, P < 0.01) as well as more GI (3.24 vs 2.27, P < 0.01) symptoms. Total health care visits made by the mother correlated with visits made by the child (rho = 0.35, P < 0.001 for cases, rho = 0.26, P < 0.001 for controls). Hypothesis 3: children learn to share the methods of coping with illness that their mothers exhibit. Methods used by children to cope with stomachaches differed from methods used by their mothers. Only 2/16 scales showed weak but significant correlations (stoicism rho = 0.13, P < 0.05; acceptance rho = 0.13, P < 0.05). Hypothesis 4: mothers and children share psychological traits such as anxiety, depression, and somatization. Child psychological distress correlated with mother’s psychological distress (rho = 0.41, P < 0.001 for cases, rho= 0.38, P < 0.001 for controls). Hypothesis 5: stress that affects the whole family might explain the similarities between mothers and their children. Family exposure to stress was not a significant predictor of children’s symptom reports. Hypothesis 6: the intergenerational transmission of GI illness behavior may be due to multiple mechanisms. Regression analysis identified multiple independent predictors of the child’s GI complaints, which were similar to the predictors of the child’s non-GI symptoms (mother’s IBS status, child psychological symptoms, child catastrophizing, and child age). CONCLUSION: Multiple factors influence the reporting of children’s gastrointestinal and non-gastrointestinal symptoms. The clustering of illness within families is best understood using a model that incorporates all these factors.

Colonoscopy and polypectomy effectively reduce the incidence and mortality of colorectal cancer, but some patients present with fully developed cancers within 1-4 yr of a colonoscopy that apparently cleared the colon of neoplasia. These events may result in medical-legal action against colonoscopists, generally based on an assumption of negligent technical performance of the procedure. Alternative explanations for the development of interval cancers include variable growth rates of colorectal cancers, the inherent miss rate of the procedure even when optimal examination techniques are used, and the possibility of flat lesions that are not readily detected by standard colonoscopic techniques. This paper discusses issues relevant to reduction of medical-legal risks associated with interval cancers after clearing colonoscopy. These issues include informed consent, documentation of cecal intubation, appropriate description of preparation, documentation of examination time and technique, and attention to potential atypical neoplasms.

Autonomic nervous system (ANS) balance was assessed in women with and without irritable bowel syndrome (IBS) using laboratory tests of function (ie, expiratory/inspiratory ratio, Valsalva, posture changes, and cold pressor) and spectral and nonspectral measures of heart rate variability (HRV). Women with (N = 103) and without IBS (N = 49) were recruited, interviewed, then completed a laboratory assessment and wore a 24-hr Holter monitor Analysis using the entire sample showed little difference between IBS and control women and between subgroups with IBS on either laboratory measures or 24-hr HRV measures. However, analysis restricted to those women with severe IBS symptoms showed quite pronounced differences between two IBS subgroups on 24-hr HRV measures. Parasympathetic tone was significantly lower and ANS balance was significantly higher in the constipation-predominant compared to the diarrhea-predominant group. Subgroups of women with IBS do differ in ANS function as measured by 24-hr HRV; however, these differences are only apparent among women with severe symptoms. These findings point out the importance of considering symptom severity when interpreting studies of IBS.

Many gastroenterology treatments would be minimally effective if patients did not adhere to prescribed therapeutic regimens. However, considerable evidence exists that patients often do not adhere. Factors associated with nonadherence include the physician's or other health care provider's behavior, the prescribed regimen, and the illness. These factors affect patient adherence such that: 1) patients do not have the skills or knowledge necessary to complete an assignment; 2) patients do not believe that they will be helped by the prevention or intervention activity, or they do not accept the activity because they do not believe that its value will outweigh its costs; and 3) patients' environments are not supportive of, or interfere with, adherence. Strategies that can increase adherence include attention to the physician/patient relationship, direct skill training, setting up a reward structure, and reminders, among others. Specific methods that gastroenterology health care providers can utilize to enhance adherence in their practice are presented.

The long-term health care costs of patients with chronic hepatitis B (CHB) were compared with those of patients without CHB. Patients with laboratory markers for CHB were identified from an HMO database and matched with up to four control patients (either not tested for hepatitis B infection or with negative test results). Cost data were collected retrospectively for both groups of patients for the period up to 30 days before identification of the first marker for hepatitis B (prediagnosis), 30 days before identification of the first marker through 180 days after the identification (peridiagnosis), and 181 days after identification through the end of the six-year study period. Costs were categorized as emergency room, inpatient, short-stay inpatient, laboratory, radiology, office visit, pharmacy, outside claim, or other and were analyzed as ratios of the costs of each patient with CHB to the median of the corresponding control patients. Eighty-eight patients were identified as having CHB; there were 342 control patients. In the seven months surrounding the appearance of their first diagnostic marker, the patients with CHB had costs 3.3 times those of the corresponding control patients and, after the first seven months, 2.9 times those of the control patients per month. Peridiagnosis costs in the categories of laboratory, radiology, office visits, and pharmacy were significantly higher for patients with CHB than for control patients. Except for emergency room costs, postdiagnosis costs per month of the patients with CHB were significantly higher than those of the corresponding control patients. Examination of an HMO database showed that, compared with patients without CHB, patients with CHB had significantly higher health care costs around and after the CHB diagnosis.

Legal and regulatory issues often receive only brief attention during medical training, given the significant competing curriculum. Medical institutions and insurance companies may educate physicians on potential liability, but the curriculum is designed to focus on the knowledge most important to protect the medical institution and insurance company, rather than the physician. While this will often overlap with protection of the individual, that is not always the case. This note will overview the ways a physician may face trouble. The purpose is to raise awareness so that one may come out unscathed (or at least, less scathed).

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.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.(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.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.

Unexplained abdominal pain in children has been shown to be related to parental responses to symptoms. This randomized controlled trial tested the efficacy of an intervention designed to improve outcomes in idiopathic childhood abdominal pain by altering parental responses to pain and children's ways of coping and thinking about their symptoms.Two hundred children with persistent functional abdominal pain and their parents were randomly assigned to one of two conditions-a three-session intervention of cognitive-behavioral treatment targeting parents' responses to their children's pain complaints and children's coping responses, or a three-session educational intervention that controlled for time and attention. Parents and children were assessed at pretreatment, and 1 week, 3 months, and 6 months post-treatment. Outcome measures were child and parent reports of child pain levels, function, and adjustment. Process measures included parental protective responses to children's symptom reports and child coping methods.Children in the cognitive-behavioral condition showed greater baseline to follow-up decreases in pain and gastrointestinal symptom severity (as reported by parents) than children in the comparison condition (time x treatment interaction, P0.01). Also, parents in the cognitive-behavioral condition reported greater decreases in solicitous responses to their child's symptoms compared with parents in the comparison condition (time x treatment interaction, P0.0001).An intervention aimed at reducing protective parental responses and increasing child coping skills is effective in reducing children's pain and symptom levels compared with an educational control condition.

All gastroenterologists are at risk of being accused of medical malpractice; few have received much training about what to do should a lawsuit occur. This article details what one can expect in a typical medical malpractice negligence claim and reviews basic relevant legal terminology. The timeline of a lawsuit is described, particularly noting the physician's role in discovery and trial. Cautions and suggestions for successful navigation of this unfamiliar and uncomfortable world are dispensed.

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.

Summary Aim To provide estimates of actual costs to deliver health care to patients with functional bowel disorders, and to assess the cost impact of symptom severity, recency of onset, and satisfaction with treatment. Methods We enrolled 558 irritable bowel (IBS), 203 constipation, 243 diarrhoea and 348 abdominal pain patients from primary care and gastroenterology clinics at a health maintenance organization within weeks of a visit. Costs were extracted from administrative claims. Symptom severity, satisfaction with treatment and out-of-pocket expenses were assessed by questionnaires. Results Average age was 52 years, 27% were males, and 59% participated. Eighty percent were seen in primary care clinics. Mean annual direct health care costs were $5049 for IBS, $6140 for diarrhoea, $7522 for constipation and $7646 for abdominal pain. Annual out-of-pocket expenses averaged $406 for treatment of IBS symptoms, $294 for diarrhoea, $390 for constipation and $304 for abdominal pain. Lower gastrointestinal costs comprised 9% of total costs for IBS, 9% for diarrhoea, 6.5% for constipation and 9% for abdominal pain. In-patient care accounted for 17.5% of total costs (15.2% IBS). Conclusion Costs were affected by disease severity (increased), recent exacerbation of bowel symptoms (increased), and whether the patient was consulting for the first time (decreased).

Physician Liability for Medical Errors of Nonphysician Clinicians: Nurse Practitioners and Physician Assistants

Summary 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.

BACKGROUND: Soy isoflavones have numerous biological properties that suggest that they may protect against colorectal cancer. Colorectal epithelial cell proliferation has been used extensively as an intermediate endpoint biomarker for colorectal neoplasia. OBJECTIVE: We tested the hypothesis that supplementation with soy protein containing isoflavones decreases colorectal epithelial cell proliferation. DESIGN: A 12-mo randomized intervention was conducted in men and women aged 50-80 y with recently diagnosed adenomatous polyps. One hundred fifty participants were enrolled and randomly assigned to an active treatment group (58 g protein powder/d containing 83 mg isoflavones/d; +ISO) or a control group (ethanol-extracted soy-protein powder containing 3 mg isoflavones; -ISO). Biopsy specimens from the cecum, sigmoid colon, and rectum were collected at baseline and at the 12-mo follow-up. Ki-67 antibody immunohistostaining was used to detect cell proliferation. One hundred twenty-five participants completed the study, and proliferation was measured in the first 91 who completed the study. RESULTS: In the sigmoid colon, cell proliferation increased by 0.9 (95% CI: 0.09, 1.9) labeled nuclei per crypt more (11%) in the +ISO group than in the -ISO group over the 12-mo intervention, which was opposite the direction predicted. The number of labeled nuclei per 100 [micro]m crypt height also increased more in the +ISO than in the -ISO group. In the cecum and sigmoid colon, but not in the rectum, the proliferation count increased as the serum genistein concentration increased. Proliferation distribution and crypt height were not changed by treatment at any site. CONCLUSIONS: Supplementation with soy protein containing isoflavones does not reduce colorectal epithelial cell proliferation or the average height of proliferating cells in the cecum, sigmoid colon, and rectum and increases cell proliferation measures in the sigmoid colon.