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S Fullerton

Publications and source records attributed to S Fullerton.

At least 19 recordsLinked to original sources
PubMed2001

Evidence- and consensus-based practice guidelines for the diagnosis of irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome (IBS) presents a significant diagnostic and management challenge for primary care practitioners. Improving the accuracy and timeliness of diagnosis may result in improved quality and efficiency of care. OBJECTIVE: To systematically appraise the existing diagnostic criteria and combine the evidence with expert opinion to derive evidence- and consensus-based guidelines for a diagnostic approach to patients with suspected IBS. METHODS: We performed a systematic literature review (January 1966-April 2000) of computerized bibliographic databases. Articles meeting explicit inclusion criteria for diagnostic studies in IBS were subjected to critical appraisal, which formed the basis of guideline statements presented to an expert panel. To develop a diagnostic algorithm, an expert panel of specialists and primary care physicians was used to fill in gaps in the literature. Consensus was developed using a modified Delphi technique. RESULTS: The systematic literature review identified only 13 published studies regarding the effectiveness of competing diagnostic approaches for IBS, the accuracy of diagnostic tests, and the internal validity of current diagnostic symptom criteria. Few studies met accepted methodological criteria. While symptom criteria have been validated, the utility of endoscopic and other diagnostic interventions remains unknown. An analysis of the literature, combined with consensus from experienced clinicians, resulted in the development of a diagnostic algorithm relevant to primary care that emphasizes a symptom-based diagnostic approach, refers patients with alarm symptoms to subspecialists, and reserves radiographic, endoscopic, and other tests for referral cases. The resulting algorithm highlights the reliance on symptom criteria and comprises a primary module, 3 submodules based on the predominant symptom pattern (constipation, diarrhea, and pain) and severity level, and a subspecialist referral module. CONCLUSIONS: The dearth of available evidence highlights the need for more rigorous scientific validation to identify the most accurate methods of diagnosing IBS. Until such time, the diagnostic algorithm presented herein could inform decision making for a range of providers caring for primary care patients with abdominal discomfort or pain and altered bowel function suggestive of IBS.

Algorithms↗
PubMed2001

Quality of life in patients with endoscopy-negative heartburn: reliability and sensitivity of disease-specific instruments.

OBJECTIVES: Endoscopy-negative gastroesophageal reflux disease (GERD) lacks objective markers of disease severity. Evaluation of therapies for GERD must therefore rely on subjective measures, including patient self-report questionnaires, to measure the clinical effectiveness of therapeutic interventions. We aimed to evaluate the previously validated Gastrointestinal Symptoms Rating Scale (GSRS) and the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaires for reliability and responsiveness to change over time. METHODS: Patients (n = 1143) with heartburn, but no esophagitis included in a randomized clinical trial assessing the effectiveness of active treatment with proton pump inhibitors over 4 wk were evaluated. RESULTS: The test-retest reliability of both questionnaires over time was good to excellent (GSRS 0.53-0.69; QOLRAD 0.65-0.76), as was the responsiveness estimated by standardized response means (GSRS reflux dimension, -1.43; QOLRAD 0.81-1.43) and effect sizes (GRSR reflux dimension, -1.74; QOLRAD 0.82-1.56). The relationship between improvement in the GSRS reflux dimension score and the amount of clinical benefit as estimated by the patients themselves (based on the Overall Treatment Evaluation) suggested a minimally clinical relevant change is 0.5 on the seven graded scales applied. The importance rating indicated that an important change in the GSRS reflux dimension and the QOLRAD dimensions is equivalent to 1.0, and a very important change to 1.5. CONCLUSIONS: The GSRS and QOLRAD are valid questionnaires that are reliable and sensitive to change. Both questionnaires should be suitable for use in clinical trials of therapeutic interventions for patients with heartburn.

Adolescent↗
PubMed2000

Sleep disturbances in clinic patients with functional bowel disorders.

OBJECTIVE: Sleep deprivation can lower visceral perception thresholds and nonregenerative sleep has been implicated as an etiological factor in chronic hyperalgesia syndromes. The aims of our study were to quantify the self-reported prevalence and type of sleep disturbances in patients with different functional bowel disorders (FBD) and to determine if this prevalence is related to involvement of the upper or lower gastrointestinal (GI) tract, perceived disease severity, or psychological comorbidity. METHODS: We enrolled 505 new FBD patients from an academic referral center specializing in functional GI disorders and 247 community based healthy controls. All patients and controls were prospectively evaluated by validated bowel symptom and sleep questionnaires. A psychological profile was obtained by SCL-90R. RESULTS: We found that 68% of functional dyspepsia (FD), 71.2% of irritable bowel syndrome (IBS)+FD, 50.2% of IBS, and 55.1% of the normal subjects reported having sleep disturbances. Waking up repeatedly during the night and waking up in the morning feeling tired or not rested were the most commonly reported sleep patterns; 57.2% of the patients reported that their abdominal ache awakened them from sleep during the night. Self-reported sleep disturbance was directly related to the perceived intensity of GI symptoms. Self-reported sleep disturbances were equally common in both male (57%) and female (58.4%) FBD patients. There was no significant difference between the mean anxiety and depression scores between patients with and without sleep dysfunction. CONCLUSIONS: FD patients, but not IBS patients, reported sleep disturbances more frequently than healthy control subjects. Abdominal pain or discomfort that awaken FBD patients from sleep during the night were common, and thus a poor discriminating factor between organic and functional disorders.

Abdominal Pain↗
PubMed1999

Measurement of symptoms in irritable bowel syndrome clinical trials.

Irritable bowel syndrome (IBS) is a chronic disorder with symptoms that range in intensity from mild and infrequent to severe and continuous. A variety of approaches to symptom assessment are used in IBS, although there is little literature directly comparing or validating them. Determining the presence or absence of specific symptoms is the primary focus of diagnostic evaluation and categorization. In contrast, outcome assessment usually entails assessment of symptom severity. Symptom severity scales can themselves vary on a wide range of factors, including specificity (pain, discomfort, gastrointestinal problem), scaling properties (numerical, analogue, or descriptor), range (usual, highest, lowest), time frame (now, past week), response category (intensity, unpleasantness, change, relief), and use of modifying variables (frequency, impact, location). The measurement properties of similar symptom scales have been investigated more extensively in the context of somatic pain, and these studies will be reviewed in suggesting some guidelines for IBS symptom assessment in clinical trials.

Colonic Diseases, Functional↗
PubMed1999

Impact of advertisement and clinic populations in symptoms and perception of irritable bowel syndrome.

BACKGROUND: This study assessed the impact of recruitment on irritable bowel syndrome clinical trials, by determining whether irritable bowel syndrome patients recruited from advertisement or a specialty clinic differ in clinical and physiologic measures. METHODS: We prospectively surveyed 657 irritable bowel syndrome patients who either: (i) were referred from a functional bowel disease clinic (52%); or (ii) responded to advertisement for clinical trials (48%), using questionnaires about bowel and psychological symptoms, and quality of life. In a subset of 42 irritable bowel syndrome patients (29 advertisement and 15 clinic patients), rectal discomfort thresholds were measured before and after repetitive sigmoid stimulation. RESULTS: While the advertisement population more commonly consulted primary care physicians, the clinic population more commonly consulted gastroenterologists. The clinic population reported more prevalent and severe abdominal pain, and higher psychological symptom scores, while the advertisement population had greater quality of life. In the visceral perception studies, both subgroups were hypersensitive to rectal distension. CONCLUSION: Compared to the clinic population, the advertisement population had less severe abdominal pain and psychological symptoms, better quality of life but similar visceral perception. The differences in clinical self-reports may have consequences for enrolment of these different patient populations into clinical trials.

Adult↗
PubMed1999

Symptoms and visceral perception in patients with pain-predominant irritable bowel syndrome.

OBJECTIVE: Abdominal pain is thought to be a hallmark of the irritable bowel syndrome (IBS), although currently used symptom criteria do not differentiate between abdominal pain and discomfort. By focusing on viscerosensory symptoms, we sought to determine: 1) which type of symptoms are most commonly reported by IBS patients, and 2) whether patients who report pain as their most bothersome symptom differ in clinical, psychological, and physiological characteristics. METHODS: A total of 443 consecutive new patient referrals to a tertiary referral center for functional gastrointestinal disorders who met symptom criteria for IBS were given validated, psychometric, health status, and bowel symptom questionnaires containing specific questions regarding the patients' predominant viscerosensory gastrointestinal symptom. Of these patients, 155 (35%) also met criteria for functional dyspepsia. A representative subset of the total IBS patient population (n = 58) underwent evaluation of perceptual responses to controlled rectal distension before and after a noxious sigmoid conditioning stimulus. RESULTS: Viscerosensory symptoms clustered into four groups: 1) abdominal pain, 2) bloating-type discomfort, 3) sensation of incomplete rectal evacuation, and 4) extraabdominal (chest pain or pressure and nausea). A total of 66% of patients reported gas as one of their viscerosensory symptoms, whereas 60% reported abdominal pain as one of their symptoms. Only 29% rated abdominal pain as their most bothersome symptom, whereas bloating-type symptoms were listed by 60% as most bothersome. Although pain predominance did not correlate with the severity of gastrointestinal or psychological symptoms, there was a significant correlation with the development of rectal hypersensitivity in response to the sigmoid conditioning stimulus. CONCLUSIONS: In a tertiary referral population of IBS patients: 1) abdominal pain is reported by only one third of patients as their most bothersome viscerosensory symptoms; and 2) pain-predominance correlates with development of rectal hypersensitivity after a noxious sigmoid stimulus.

Abdominal Pain↗
PubMed1998

Intestinal and extraintestinal symptoms in functional gastrointestinal disorders.

Functional gastrointestinal disorders such as irritable bowel syndrome or functional dyspepsia have traditionally been regarded as syndromes limited to the digestive system. However, both clinical experience and published evidence show that patients with such disorders also report a series of other symptoms of physical distress, such as fibromyalgia and irritable bladder and alterations in vital functions, such as sleep, libido, appetite and energy level. Some of these extraintestinal symptoms can be explained in the context of an evolving comprehensive disease model which views functional gastrointestinal disorders as manifestations of alterations in the interactions between the nervous system, the viscera and the musculoskeletal system. Alterations in central circuits concerned with arousal, attention and fear, cognitions about bodily symptoms and possible alterations in the hypothalamic pituitary adrenal (HPA) axis may all contribute to the wide range of symptoms reported by affected patients.

Colonic Diseases, Functional↗
PubMed1998

Functional digestive disorders (FDD) in the year 2000--economic impact.

OBJECTIVE: The objective of this study is to quantify the future worldwide economic impact of functional gastrointestinal disease and to describe international differences that might exist between major industrialized countries. DESIGN: This study employs an econometric projection using data from the only known survey of national economic impact of functional gastrointestinal disease. Economic costs from this survey are combined with country specific population estimates, health care spending characteristics, and growth rates to estimate economic impact for major industrial countries. RESULTS: The estimated economic impact of functional gastrointestinal disease for eight major industrial countries is over 41 billion U.S. dollars annually. This estimate includes both direct and indirect costs of disease. CONCLUSION: The economic impact of functional gastrointestinal disease is large. Economic estimates are useful in policy decision making regarding the allocation of health care resources.

Canada↗
PubMed1998

The impact of managed care on gastroenterology.

Managed care has emerged out o pressures to reduce the high cost of healthcare and has brought about unprecedented change and uncertainty for the specialist. To flourish in a managed care environment the subspecialist will need to rely on strategic planning. Four emerging approached to healthcare lend themselves to strategic planning. They are 1) practice-based clinical trials, 2) outcomes research, 3) clinical practice guidelines, and 4) systems-based disease management. This report explains how subspecialists in private practice can participate in and profit from each of these new approaches.

Clinical Trials as Topic↗
PubMed1998

Effect of amitriptyline on symptoms, sleep, and visceral perception in patients with functional dyspepsia.

OBJECTIVE: Tricyclic antidepressants in low doses are widely used in the therapy of patients with functional gastrointestinal disorders, yet the mechanism(s) of action of these drugs in these disorders is not known. In the current study, we sought to determine in a group of patients with functional dyspepsia and associated poor sleep how amitryptiline affects digestive symptoms, perceptual responses to gastric distension, and subjective and objective measures of sleep. METHODS: Patients were randomized to 4 wk of amitryptiline 50 mg taken at bedtime versus placebo. There was a 3-wk washout phase, followed by a cross-over to the alternate treatment. Perceptual sensitivity to gastric distention and sleep EEG were recorded at the end of each treatment period. Diaries of symptoms were maintained throughout. RESULTS: Seven of seven patients reported significantly less severe gastrointestinal symptoms after 4 wk on amitryptiline compared to placebo. Five of seven patients had evidence for altered perception of gastric balloon distension during placebo. However, the subjective symptom improvement on amitryptiline was not associated with a normalization of the perceptual responses to gastric distension. Baseline sleep dysfunction in the form of reduced sleep efficiency, increased arousal, or abnormal amounts of REM sleep was found in all seven patients. Amitryptiline significantly reduced absolute and relative amounts of REM sleep, but had no effect on sleep parameters related to nonregenerative sleep. CONCLUSION: The beneficial effect of low dose amitryptiline seen in functional dyspepsia is not related to changes in perception of gastric distension, or to measures of arousal from sleep. An increased tolerance to aversive visceral sensations may play a role in the therapeutic effect.

Adult↗
PubMed1998

Symptoms and visceral perception in severe functional and organic dyspepsia.

BACKGROUND: Hypersensitivity of gastric afferent pathways may play an aetiological role in symptoms of functional dyspepsia. AIMS: To determine whether patients with severe organic dyspepsia (associated with tissue irritation/injury) and those with functional dyspepsia (no detectable tissue irritation) differ in their perception of gastric distension and whether this difference is reflected in differences in their gastrointestinal and psychological symptoms. METHODS: Perceptual thresholds, referral patterns, and gastrointestinal and psychological symptoms were compared in 23 patients with functional dyspepsia, 10 organic dyspeptics, and 15 healthy controls. RESULTS: Fifteen (65%) functional dyspeptics and no organic dyspeptics had reduced perceptual thresholds for fullness, discomfort, or pain (odds ratio (OR) 19.56, 95% confidence interval (CI) 1.95 to 476.09, p = 0.0017). Either reduced perceptual thresholds or altered referral was found in 20 (87%) functional dyspeptics and four (20%) organic dyspeptics (OR 10.0, 95% CI 1.34 to 89.54, p = 0.014). During sham distension fullness, discomfort and pain were reported by healthy controls, organic dyspeptics, and functional dyspeptics. A sham response of pain but no other sensation was more frequent among functional dyspeptics (43%) than healthy controls (7%) (OR 10.77, 95% CI 1.10 to 257.35, p = 0.026). Gastrointestinal and psychological symptoms and gastric compliance were similar in the functional and organic groups. CONCLUSIONS: Alterations in the perception of gastric distension distinguishes between functional and organic dyspepsia, while symptoms do not. A total of 87% of functional dyspeptics studied had evidence of altered visceral afferent function. In this study population, psychological abnormalities or changes in compliance did not explain the findings.

Adult↗
PubMed1998

Sexual dysfunction in patients with irritable bowel syndrome and non-ulcer dyspepsia.

The prevalence and type of sexual dysfunction in patients with functional gastrointestinal (GI) disorders involving the upper (functional dyspepsia) or lower GI tract (irritable bowel syndrome) were studied in 683 patients seen at a tertiary referral center and a comparison group of 247 community volunteers. Associations between sexual dysfunction and type and severity of GI symptoms, and psychological symptoms were examined. All subjects were evaluated with a validated bowel syndrome questionnaire, which included questions about sexual function. Psychological symptom severity was assessed by SCL-90R. The prevalence of self-reported sexual dysfunction in patients with functional GI disorders was 43.3% and did not differ by gender, age stratification or disease subtype: irritable bowel syndrome (IBS); non-ulcer dyspepsia (NUD), and IBS + NUD. In the comparison subjects without IBS symptoms and those with IBS symptoms but not seeking health care (IBS non-patients), the reported sexual dysfunction prevalence was significantly lower (16.1 and 24.4%, respectively, p < 0.005). Decreased sexual drive was the symptom most commonly reported by both male (36.2%) and female (28.4%) patients. Dyspareunia was reported by 16.4% of females and 4% of males with IBS, but was rarely observed in patients with NUD. Report of sexual dysfunction was positively associated with perceived GI symptom severity, but not with psychological symptom severity. Sexual dysfunction should be incorporated into the quality-of-life assessment of patients with functional GI disorders and addressed in future outcome studies.

Adult↗
PubMed1997

Management strategies for Helicobacter pylori-seropositive patients with dyspepsia: clinical and economic consequences.

BACKGROUND: Noninvasive testing for Helicobacter pylori is widely available and has been considered as an initial management strategy for uninvestigated dyspepsia. However, data to guide clinicians in the management of patients with dyspepsia who are seropositive for H. pylori are lacking. OBJECTIVE: To examine the economic, clinical, and policy implications of alternative initial management strategies for patients with uninvestigated dyspepsia who are seropositive for H. pylori. DESIGN: Decision analysis comparing the costs and outcomes of initial anti-H. pylori therapy and initial endoscopy. PATIENTS: Helicobacter pylori-seropositive patients with dyspepsia. MEASUREMENTS: Cost estimates were obtained from the Medicare reimbursement schedule and a health maintenance organization pharmacy. Probability estimates were derived from the medical literature. RESULTS: Initial endoscopy costs an average of $1276 per patient, whereas initial anti-H, pylori therapy costs $820 per patient; the average saving is $456 per patient treated. The financial effect of a 252% increase in the use of antibiotics for initial H. pylori therapy is more than offset by reducing the endoscopy workload by 53%. Endoscopy-related costs must be reduced by 96% before the two strategies become equally cost-effective. In patients with nonulcer dyspepsia, the financial benefits of initial anti-H. pylori therapy are not substantially affected by varying the rates of H. pylori eradication, the complications of antibiotics, or the response of symptoms to cure of H. pylori infection. CONCLUSIONS: In H. pylori-seropositive patients with dyspepsia, initial anti-H. pylori therapy is the most cost, effective management strategy. Randomized studies of these strategies that evaluate outcomes and patient preferences are needed to optimize management decisions. In the meantime, unless physicians are concerned about resistance to antimicrobial agents or the lack of proven benefit of anti-H. pylori therapy in nonucler dyspepsia, the strategy outlined in this analysis can be used as a basis for management and policy decisions about H. pylori-seropositive patients with dyspepsia.

Age Factors↗
PubMed1997

Sigmoid afferent mechanisms in patients with irritable bowel syndrome.

Up to 60% of patients with IBS have lowered perception thresholds in the rectum to balloon distension. The current study sought to test the hypothesis that IBS patients with normal perception thresholds in the rectum show hypersensitivity of afferent pathways in the sigmoid colon. Eleven healthy normal subjects and eight IBS patients with normal rectal perception thresholds underwent a balloon distension protocol in the sigmoid and rectum. Discomfort thresholds, receptive relaxation, compliance, and referral patterns were measured. Although IBS patients had significantly lower discomfort thresholds in the sigmoid when measured as volume, pressure, and wall tension, thresholds were similar to normals. Receptive relaxation and dynamic compliance were significantly decreased in IBS patients in the sigmoid. Referral patterns were similar during sigmoid distention in IBS patients in comparison to normals. Despite normal perception thresholds in rectum and sigmoid, IBS patients show evidence for alterations in rectosigmoid afferent mechanisms. In the sigmoid, this is seen in the form of reduced reflex relaxation and compliance and in the rectum in the form of altered viscerosomatic referral.

Adult↗
PubMed1997

Patient-perceived severity of irritable bowel syndrome in relation to symptoms, health resource utilization and quality of life.

AIM: In this study of patients with irritable bowel syndrome (IBS), we evaluated the relationship between patient-rated severity of IBS and patients' physical and psychological symptoms, health care resource use and quality of life. METHODS: One hundred and twenty-six patients diagnosed with IBS were administered a series of questionnaires, including the Bowel Symptom Checklist, the Symptom Checklist-90-R (a psychological symptom checklist), the IBSQOL (a disease-specific quality of life instrument), the SF-36 (a general health status instrument), and a health resource utilization assessment that measured health care use, time loss from work, impact on productivity, and days worked with symptoms. RESULTS: No relationship was found between IBS severity and gastrointestinal symptoms, except for a feeling of unpassed stool. IBS severity was also not related to psychological symptom severity. Direct traditional indicators of resource use (e.g. physician visits, hospital admissions and emergency room visits) were not significantly associated by severity level; however, indirect measures of resource use (e.g. number of days with pain, productivity and number of bed days) were related to severity. Quality of life was clearly associated with perceived IBS severity. Patients who rated themselves as very severe reported the lowest scores and had the poorest health for all quality of life dimensions measured. CONCLUSIONS: These findings suggest that perceived IBS severity is defined by the limitations the disease imposes, rather that by the symptoms. Patients with reduced productivity and decreased functioning for most of the quality of life indicators were those who rated their IBS as very severe.

Absenteeism↗
PubMed1997

Evaluation of a new quality of life questionnaire for patients with irritable bowel syndrome.

BACKGROUND: We describe the development and evaluation of a new disease-specific instrument, the Irritable Bowel Syndrome Quality of Life Questionnaire (IBSQOL), which was designed for use in patients with irritable bowel syndrome. The IBSQOL measures 10 domains found to be relevant to patients with irritable bowel syndrome: emotional health, mental health, health belief, sleep, energy, physical functioning, diet, social role, physical role, and sexual relations. METHODS: During its development and evaluation, the IBSQOL was administered to over 500 patients with irritable bowel syndrome--two groups of patients from tertiary care centres, three focus groups of 8-12 patients each, and 287 patients in a national irritable bowel syndrome support network. As a control, the IBSQOL was also administered to 37 patients who did not have irritable bowel syndrome but had other gastrointestinal disorders. Statistical analyses to test the reliability and validity of the IBSQOL were performed using Cronbach's alpha coefficient. RESULTS: Responses from the focus groups indicated that the IBSQOL was easy to complete and did not require too much time to fill out (approximately equal to 25 min). Statistical analyses of the final 30-item version of the IBSQOL demonstrated that it had both adequate validity and reliability (alpha > or = 0.60). A comparison of mean IBSQOL scores of persons with and without irritable bowel syndrome (but with other gastrointestinal conditions) showed no difference between the two groups with irritable bowel syndrome; however, scores for both irritable bowel syndrome groups were considerably lower than for the non-irritable bowel syndrome group, suggesting better health-related quality of life in patients who do not have irritable bowel syndrome. This further demonstrated the validity of the IBSQOL in targeting questions and domains specific to patients with irritable bowel syndrome. CONCLUSIONS: Evaluation of the IBSQOL included testing the questionnaire in a large number of patients, which resulted in a revised and well-constructed instrument that demonstrated both adequate validity and reliability. The IBSQOL is currently being used in large-scale clinical trials to measure changes in quality of life in patients with irritable bowel syndrome following treatment intervention.

Adult↗
PubMed1997

Evidence for two distinct perceptual alterations in irritable bowel syndrome.

BACKGROUND: Visceral hyperalgesia has been implicated as a factor contributing to symptom generation in irritable bowel syndrome (IBS). However, previous studies using intestinal balloon distension have used psychophysical procedures which do not provide adequate and unbiased measures of visceral sensitivity. METHODS: Three psychophysical tasks were examined in 45 patients with IBS (positive Rome criteria) and 14 controls using rectal balloon distension with a computerised distension device. Discomfort threshold and tolerance were assessed during an ascending series of phasic pressure stimuli and during an interactive threshold tracking procedure. In addition, stimulus response functions were generated from intensity and unpleasantness ratings of the rectal distensions. RESULTS: Discomfort threshold and tolerance for the ascending stimuli were significantly lower for the patients with IBS compared with the controls. In contrast, discomfort thresholds during the tracking procedure and stimulus response curves for the ascending series were not different between the groups. A factor analysis of the psychophysical data was consistent with the presence of two distinct and unrelated perceptual alterations related to rectal distension: hypervigilance for visceral stimuli, manifested as lowered response criteria for using the descriptor "discomfort"; and rectal hypersensitivity, manifested as a lower discomfort threshold and left shift of the stimulus response curves. CONCLUSIONS: Patients with IBS as a group have a greater propensity to label visceral sensations negatively and show a lower tolerance for rectal balloon distension. A subgroup of patients also have baseline rectal hypersensitivity, assessed by unbiased measures of discomfort threshold and stimulus intensity judgements.

Adult↗