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M1322 Upper Gastrointestinal Symptoms and Not Lower Gastrointestinal Symptoms are More Common in Diabetics Than Healthy Controls
M1319 M1321
Do IBS Patients Understand the Difference Between Abdominal Pain vs. Discomfort? Implications for Clinical Practice and Clinical Trial Design Brennan M. Spiegel, Roger E. Bolus, Lucinda A. Harris, Susan L. Lucak, Eric Esrailian, William D. Chey, Anthony Lembo, Hetal A. Karsan, Kirsten Tillisch, Jennifer Talley, Lin Chang
Abdominal Pain: An Under Appreciated Symptom in Gastroparesis Dinu Cherian, Priyanka Sachdeva, Robert S. Fisher, Henry P. Parkman
Background: Although the Rome III criteria allow either abdominal pain or “discomfort” to diagnose IBS, earlier criteria specified pain - not discomfort - as the hallmark IBS symptom. Moreover, pain is the principal driver of illness severity in IBS. However, it remains unclear whether patients understand the difference between pain and discomfort and, if so, what they perceive the difference to be. This has important implications for validating diagnostic criteria and crafting future IBS patient reported outcomes (PROs). We elicited IBS patients' understanding of pain vs. discomfort. Methods: We surveyed Rome III IBS subjects from the Patient Reported Observed Outcomes and Function (PROOF) Cohort - a multi-center IBS registry. The survey posed the following: “Patients with IBS often use the word ‘pain' and/ or ‘discomfort' to describe what they are feeling in their belly. Do you think there is a difference between ‘pain' and ‘discomfort?” Responses included: “Yes - pain is different from discomfort;” “No - pain and discomfort are the same;” and “Unsure.” Patients endorsing “yes” were asked to describe the difference using open ended text. Patients then classified each of 7 cardinal IBS symptoms as “painful,” “uncomfortable,” “both painful and uncomfortable,” or “neither.” Results: Of the 102 subjects (mean age=43; 79% F; 18% IBS-C; 33% IBS-D; 49% IBS-M), 91 (89%) reported that pain and discomfort are different. In qualitative responses, 14% described pain vs. discomfort as extremes on a shared sensory scale, 36% described them as different symptom categories, and 50% described them in terms of varying functional impact. Other than abdominal pain, none of the other IBS symptoms were perceived as being predominantly painful, rather >50% of subjects reported each of their IBS symptoms as predominantly “uncomfortable”, except for straining (36%). The percentage reporting each symptom as either “uncomfortable” or “both painful and uncomfortable” were 91%, 90%, 90%, 85%, 81%, 81%, and 64% for bloating, distension, fullness, incomplete evacuation, gas, urgency and straining, respectively. Conclusion: Most IBS patients believe pain and discomfort are different; when asked to explain the difference, patients exhibit wide variations in their understanding. Most IBS symptoms, other than abdominal pain itself, are considered “uncomfortable.” Thus, asking patients about discomfort is nonspecific because it encompasses many symptoms and concepts. Future iterations of IBS diagnostic criteria and PROs should distinguish pain from discomfort and delineate individual discomfort symptoms rather than aggregating under the shared “discomfort” construct.
Symptoms of gastroparesis have focused mainly on early satiety, nausea and vomiting. Previous studies, however, have reported abdominal pain of varying degrees in patients with gastroparesis. The aim of this study was to define the prevalence, severity, and quality of abdominal pain in patients with gastroparesis and to correlate abdominal pain with gastric emptying (GE) and quality of life. Methods: Patients referred to Temple University Hospital for presumed gastroparesis underwent 4-hr GE scintigraphy and upper endoscopy. Patients filled out the Patient Assessment of GI Symptoms questionnaire (PAGI-SYM), a quality of life questionnaire (PAGI-QOL), and an abdominal pain questionnaire derived from validated pain questionnaires (Short-Form McGill Pain Questionnaire and Short-Form Brief Pain Inventory). Results: The study group consisted of 55 patients (48 females; 7 males) with delayed GE (13 diabetics (DG) and 42 idiopathics (IG)) seen from May to Nov 2009. Abdominal pain was present in 89% of patients (85% DG, 91% IG) compared to nausea which was present in 95% of patients (100% DG, 93% IG). The location of abdominal pain was epigastric in 47%, periumbilical in 12%, and suprapubic in 12%. Pain occurred daily in 35% of patients and intermittently in 65%. Abdominal pain was brought on by eating in 71%; many patients also had nocturnal pain (76%) that interfered with sleep (63%). Patients described the pain as mild (27%) or discomforting (24%). The abdominal pain was characterized on a 3 point scale as: sickening (1.8±0.2), cramping (1.7±0.2), tiring-exhausting (1.6±0.2), sharp (1.5±0.2), tender (1.4±0.2) and aching (1.4±0.2). The severity ranking of symptoms based on the 5-point PAGI-SYM scores were: abdominal fullness (3.8±0.2), bloating (3.7±0.3), nausea (3.4±0.2), upper abdominal discomfort (3.4±0.2), upper abdominal pain (3.1±0.3) and vomiting (2.2±0.3). IG patients tended to have more severe upper abdominal pain compared to DG (3.2±0.3 vs 2.6±0.5, p=0.16) and nausea (3.6±0.2 vs 2.9±0.5, p=0.08). Abdominal pain did not correlate with GE (2-hr GE: r=0.06; p=0.65 and 4-hr GE r=0.02; p=0.90). Abdominal pain severity correlated with quality of life showing moderate correlation with taking longer to do daily activities (r=0.61, p<0.001), depending on others to do daily activities (r=0.57, p<0.001), avoiding daily activities (r=0.56, p<0.001), and feeling tired (r=0.54, p<0.001). Conclusions: Abdominal pain is a significant symptom in gastroparesis, comparable to nausea and more severe than vomiting. Abdominal pain correlated with impaired quality of life but not with GE. Thus, abdominal pain is an important symptom in patients with gastroparesis.
M1320
M1322
Characterizing “Bowel Urgency”: Guidance for Outcome Assessment in Patients With Diarrhea Predominant IBS Brennan M. Spiegel, Roger E. Bolus, Lucinda A. Harris, Susan L. Lucak, Eric Esrailian, William D. Chey, Anthony Lembo, Hetal A. Karsan, Kirsten Tillisch, Jennifer Talley, Lin Chang
Upper Gastrointestinal Symptoms and Not Lower Gastrointestinal Symptoms are More Common in Diabetics Than Healthy Controls Reza A. Hejazi, Peter Beyer, Qingjiang Hou, Richard McCallum Background: The prevalence of gastrointestinal (GI) symptoms has been reported to be increased in diabetes mellitus (DM), but there are few comprehensive studies which compared the GI symptoms in diabetics with healthy matched controls. The previous studies have concluded that lower GI (LGI) symptoms, particularly constipation are the commonest GI complications in diabetics. Aims: To compare the frequency of GI symptoms in patients with DM with non-diabetic controls. Methods: The prevalence of 9 upper GI (UGI) and 5 LGI symptoms were measured in outpatients with DM attending diabetic clinics at an academic medical center and compared to age/gender matched, non-diabetic controls. Symptoms were assessed over the previous 4 weeks using a standardized questionnaire. Scores for each symptom ranged from 0-4 to correspond with the number of weeks the symptom occurred in the last month. Overall UGI & LGI symptom scores were computed from total scores. McNemar's chi-square test was performed for each of the 14 GI symptoms. A pvalue of < 0.05, with a CI 95% was considered significant. Results: 196 patients with DM [97 female, (98 type II & 71 type I)] with mean age of 46 yrs were included. The mean duration of DM was 12.3 yrs. 196 age/gender matched healthy controls were the comparison group. The mean overall UGI symptom score was significantly higher in DM (6.79 vs 4.55, P<0.05) but not for LGI symptoms (2.75 vs 2.68, p=0.86). The individual scores for loss of appetite, belching, epigastric pain, nausea/vomiting and fullness were all significantly greater in the DM group but difficult/painful swallowing, heartburn, abdominal bloating, cramping, diarrhea, steatorrhea, fecal incontinence and constipation were not significantly different from non-diabetic controls. Increasing HbA1c was significantly correlated with total UGI symptoms scor (p=0.003). Conclusions: 1) The overall frequency score for UGI symptoms in outpatients with type I & II DM was significantly greater than for age and gender matched controls with the individual upper GI symptoms scores typically associated with the diagnosis of “dyspepsia” being the most prevalent. 2) In contrast to previous research the LGI scores were not significantly different in DM than the control population. 3) Poor diabetic control correlated with total UGI symptoms scores. 4) Because “dyspepsia” can represent a motility disorder, eliciting GI symptoms should be a routine part of the evaluation of diabetic patients.
Background: Patients with diarrhea-predominant IBS (D-IBS) often experience bowel urgency. We have shown that urgency is an independent driver of illness severity in IBS, and current efforts are underway to develop patient reported outcomes (PROs) that measure urgency for D-IBS trials. Yet it remains unclear how patients perceive and define urgency or how best to measure this common and disruptive symptom. Understanding the patients' perspective is vital for crafting future urgency PROs. We performed qualitative & quantitative assessments of patient impressions about urgency. Methods: We performed online “virtual cognitive interviews” of 35 Rome III D-IBS subjects from the Patient Reported Observed Outcomes and Function Cohort - a multicenter IBS registry. We asked patients to report their most bothersome symptoms; those reporting urgency were asked: “What does ‘bowel urgency' mean to you?” In addition, patients rated 4 attributes of urgency, including frequency, intensity, interference, & fluctuation. We evaluated the association of each attribute across IBS severity metrics, including IBS-QOL, severity numeric rating scale (NRS), & pain NRS. Results: There were 35 D-IBS patients of whom 33 reported urgency (age=43; 79% F). In qualitative responses, patients reported 4 hierarchically ordered characterizations of urgency: 1) simple symptom description (12%); 2) emphasis on immediacy of symptom (43%); 3) emphasis that immediacy impacts controllability (33%); & 4) emphasis that immediacy and controllability impact psychosocial functioning (12%). All urgency attributes had significant independent associations with the severity metrics (Table); interference & fluctuation demonstrated the highest relationships. Conclusions: Urgency in D-IBS is multifaceted with some symptom attributes driving illness severity more than others. Urgency is not a unidimensional symptom. Future urgency PRO development should consider multiple attributes of urgency, including interference, fluctuation, frequency, and intensity. Moreover, items in an urgency PRO might be expressed in a conceptual framework measured with 4 hierarchically related scales: 1) symptom description stratified by urgency attributes; 2) immediacy; 3) controllability; 4) psychosocial impact. This structure may lead to a novel measure of severity. Urgency Attributes and Severity Metrics [r-value (p-value)]
S-379
AGA Abstracts
AGA Abstracts
bias although there was moderate heterogeneity. Using the pooled results of age- and sexmatched studies, the diagnostic utility of breath testing demonstrated a sensitivity and specificity of 93 and 40 percent, respectively. Conclusion: Although there is heterogeneity among studies of breath testing in IBS, early and elevated hydrogen on breath testing appear more common in IBS subjects compared to controls. Whether this represents bacterial overgrowth or colonic flora will need to wait for a better gold standard than simple culture techniques.
Do IBS Patients Understand the Difference Between Abdominal Pain vs. Discomfort? Implications for Clinical Practice and Clinical Trial Design Brennan M. Spiegel, Roger E. Bolus, Lucinda A. Harris, Susan L. Lucak, Eric Esrailian, William D. Chey, Anthony Lembo, Hetal A. Karsan, Kirsten Tillisch, Jennifer Talley, Lin Chang
Abdominal Pain: An Under Appreciated Symptom in Gastroparesis Dinu Cherian, Priyanka Sachdeva, Robert S. Fisher, Henry P. Parkman
Background: Although the Rome III criteria allow either abdominal pain or “discomfort” to diagnose IBS, earlier criteria specified pain - not discomfort - as the hallmark IBS symptom. Moreover, pain is the principal driver of illness severity in IBS. However, it remains unclear whether patients understand the difference between pain and discomfort and, if so, what they perceive the difference to be. This has important implications for validating diagnostic criteria and crafting future IBS patient reported outcomes (PROs). We elicited IBS patients' understanding of pain vs. discomfort. Methods: We surveyed Rome III IBS subjects from the Patient Reported Observed Outcomes and Function (PROOF) Cohort - a multi-center IBS registry. The survey posed the following: “Patients with IBS often use the word ‘pain' and/ or ‘discomfort' to describe what they are feeling in their belly. Do you think there is a difference between ‘pain' and ‘discomfort?” Responses included: “Yes - pain is different from discomfort;” “No - pain and discomfort are the same;” and “Unsure.” Patients endorsing “yes” were asked to describe the difference using open ended text. Patients then classified each of 7 cardinal IBS symptoms as “painful,” “uncomfortable,” “both painful and uncomfortable,” or “neither.” Results: Of the 102 subjects (mean age=43; 79% F; 18% IBS-C; 33% IBS-D; 49% IBS-M), 91 (89%) reported that pain and discomfort are different. In qualitative responses, 14% described pain vs. discomfort as extremes on a shared sensory scale, 36% described them as different symptom categories, and 50% described them in terms of varying functional impact. Other than abdominal pain, none of the other IBS symptoms were perceived as being predominantly painful, rather >50% of subjects reported each of their IBS symptoms as predominantly “uncomfortable”, except for straining (36%). The percentage reporting each symptom as either “uncomfortable” or “both painful and uncomfortable” were 91%, 90%, 90%, 85%, 81%, 81%, and 64% for bloating, distension, fullness, incomplete evacuation, gas, urgency and straining, respectively. Conclusion: Most IBS patients believe pain and discomfort are different; when asked to explain the difference, patients exhibit wide variations in their understanding. Most IBS symptoms, other than abdominal pain itself, are considered “uncomfortable.” Thus, asking patients about discomfort is nonspecific because it encompasses many symptoms and concepts. Future iterations of IBS diagnostic criteria and PROs should distinguish pain from discomfort and delineate individual discomfort symptoms rather than aggregating under the shared “discomfort” construct.
Symptoms of gastroparesis have focused mainly on early satiety, nausea and vomiting. Previous studies, however, have reported abdominal pain of varying degrees in patients with gastroparesis. The aim of this study was to define the prevalence, severity, and quality of abdominal pain in patients with gastroparesis and to correlate abdominal pain with gastric emptying (GE) and quality of life. Methods: Patients referred to Temple University Hospital for presumed gastroparesis underwent 4-hr GE scintigraphy and upper endoscopy. Patients filled out the Patient Assessment of GI Symptoms questionnaire (PAGI-SYM), a quality of life questionnaire (PAGI-QOL), and an abdominal pain questionnaire derived from validated pain questionnaires (Short-Form McGill Pain Questionnaire and Short-Form Brief Pain Inventory). Results: The study group consisted of 55 patients (48 females; 7 males) with delayed GE (13 diabetics (DG) and 42 idiopathics (IG)) seen from May to Nov 2009. Abdominal pain was present in 89% of patients (85% DG, 91% IG) compared to nausea which was present in 95% of patients (100% DG, 93% IG). The location of abdominal pain was epigastric in 47%, periumbilical in 12%, and suprapubic in 12%. Pain occurred daily in 35% of patients and intermittently in 65%. Abdominal pain was brought on by eating in 71%; many patients also had nocturnal pain (76%) that interfered with sleep (63%). Patients described the pain as mild (27%) or discomforting (24%). The abdominal pain was characterized on a 3 point scale as: sickening (1.8±0.2), cramping (1.7±0.2), tiring-exhausting (1.6±0.2), sharp (1.5±0.2), tender (1.4±0.2) and aching (1.4±0.2). The severity ranking of symptoms based on the 5-point PAGI-SYM scores were: abdominal fullness (3.8±0.2), bloating (3.7±0.3), nausea (3.4±0.2), upper abdominal discomfort (3.4±0.2), upper abdominal pain (3.1±0.3) and vomiting (2.2±0.3). IG patients tended to have more severe upper abdominal pain compared to DG (3.2±0.3 vs 2.6±0.5, p=0.16) and nausea (3.6±0.2 vs 2.9±0.5, p=0.08). Abdominal pain did not correlate with GE (2-hr GE: r=0.06; p=0.65 and 4-hr GE r=0.02; p=0.90). Abdominal pain severity correlated with quality of life showing moderate correlation with taking longer to do daily activities (r=0.61, p<0.001), depending on others to do daily activities (r=0.57, p<0.001), avoiding daily activities (r=0.56, p<0.001), and feeling tired (r=0.54, p<0.001). Conclusions: Abdominal pain is a significant symptom in gastroparesis, comparable to nausea and more severe than vomiting. Abdominal pain correlated with impaired quality of life but not with GE. Thus, abdominal pain is an important symptom in patients with gastroparesis.
M1320
M1322
Characterizing “Bowel Urgency”: Guidance for Outcome Assessment in Patients With Diarrhea Predominant IBS Brennan M. Spiegel, Roger E. Bolus, Lucinda A. Harris, Susan L. Lucak, Eric Esrailian, William D. Chey, Anthony Lembo, Hetal A. Karsan, Kirsten Tillisch, Jennifer Talley, Lin Chang
Upper Gastrointestinal Symptoms and Not Lower Gastrointestinal Symptoms are More Common in Diabetics Than Healthy Controls Reza A. Hejazi, Peter Beyer, Qingjiang Hou, Richard McCallum Background: The prevalence of gastrointestinal (GI) symptoms has been reported to be increased in diabetes mellitus (DM), but there are few comprehensive studies which compared the GI symptoms in diabetics with healthy matched controls. The previous studies have concluded that lower GI (LGI) symptoms, particularly constipation are the commonest GI complications in diabetics. Aims: To compare the frequency of GI symptoms in patients with DM with non-diabetic controls. Methods: The prevalence of 9 upper GI (UGI) and 5 LGI symptoms were measured in outpatients with DM attending diabetic clinics at an academic medical center and compared to age/gender matched, non-diabetic controls. Symptoms were assessed over the previous 4 weeks using a standardized questionnaire. Scores for each symptom ranged from 0-4 to correspond with the number of weeks the symptom occurred in the last month. Overall UGI & LGI symptom scores were computed from total scores. McNemar's chi-square test was performed for each of the 14 GI symptoms. A pvalue of < 0.05, with a CI 95% was considered significant. Results: 196 patients with DM [97 female, (98 type II & 71 type I)] with mean age of 46 yrs were included. The mean duration of DM was 12.3 yrs. 196 age/gender matched healthy controls were the comparison group. The mean overall UGI symptom score was significantly higher in DM (6.79 vs 4.55, P<0.05) but not for LGI symptoms (2.75 vs 2.68, p=0.86). The individual scores for loss of appetite, belching, epigastric pain, nausea/vomiting and fullness were all significantly greater in the DM group but difficult/painful swallowing, heartburn, abdominal bloating, cramping, diarrhea, steatorrhea, fecal incontinence and constipation were not significantly different from non-diabetic controls. Increasing HbA1c was significantly correlated with total UGI symptoms scor (p=0.003). Conclusions: 1) The overall frequency score for UGI symptoms in outpatients with type I & II DM was significantly greater than for age and gender matched controls with the individual upper GI symptoms scores typically associated with the diagnosis of “dyspepsia” being the most prevalent. 2) In contrast to previous research the LGI scores were not significantly different in DM than the control population. 3) Poor diabetic control correlated with total UGI symptoms scores. 4) Because “dyspepsia” can represent a motility disorder, eliciting GI symptoms should be a routine part of the evaluation of diabetic patients.
Background: Patients with diarrhea-predominant IBS (D-IBS) often experience bowel urgency. We have shown that urgency is an independent driver of illness severity in IBS, and current efforts are underway to develop patient reported outcomes (PROs) that measure urgency for D-IBS trials. Yet it remains unclear how patients perceive and define urgency or how best to measure this common and disruptive symptom. Understanding the patients' perspective is vital for crafting future urgency PROs. We performed qualitative & quantitative assessments of patient impressions about urgency. Methods: We performed online “virtual cognitive interviews” of 35 Rome III D-IBS subjects from the Patient Reported Observed Outcomes and Function Cohort - a multicenter IBS registry. We asked patients to report their most bothersome symptoms; those reporting urgency were asked: “What does ‘bowel urgency' mean to you?” In addition, patients rated 4 attributes of urgency, including frequency, intensity, interference, & fluctuation. We evaluated the association of each attribute across IBS severity metrics, including IBS-QOL, severity numeric rating scale (NRS), & pain NRS. Results: There were 35 D-IBS patients of whom 33 reported urgency (age=43; 79% F). In qualitative responses, patients reported 4 hierarchically ordered characterizations of urgency: 1) simple symptom description (12%); 2) emphasis on immediacy of symptom (43%); 3) emphasis that immediacy impacts controllability (33%); & 4) emphasis that immediacy and controllability impact psychosocial functioning (12%). All urgency attributes had significant independent associations with the severity metrics (Table); interference & fluctuation demonstrated the highest relationships. Conclusions: Urgency in D-IBS is multifaceted with some symptom attributes driving illness severity more than others. Urgency is not a unidimensional symptom. Future urgency PRO development should consider multiple attributes of urgency, including interference, fluctuation, frequency, and intensity. Moreover, items in an urgency PRO might be expressed in a conceptual framework measured with 4 hierarchically related scales: 1) symptom description stratified by urgency attributes; 2) immediacy; 3) controllability; 4) psychosocial impact. This structure may lead to a novel measure of severity. Urgency Attributes and Severity Metrics [r-value (p-value)]
S-379
AGA Abstracts
AGA Abstracts
bias although there was moderate heterogeneity. Using the pooled results of age- and sexmatched studies, the diagnostic utility of breath testing demonstrated a sensitivity and specificity of 93 and 40 percent, respectively. Conclusion: Although there is heterogeneity among studies of breath testing in IBS, early and elevated hydrogen on breath testing appear more common in IBS subjects compared to controls. Whether this represents bacterial overgrowth or colonic flora will need to wait for a better gold standard than simple culture techniques.