Dataset Information

A rapid, simple questionnaire to assess gastrointestinal symptoms after oral ferrous sulphate supplementation.

ABSTRACT: Oral iron supplementation is often associated with rapid onset of gastrointestinal side-effects. The aim of this study was to develop and trial a short, simple questionnaire to capture these early side-effects and to determine which symptoms are more discriminating.The study was a double-blind placebo-controlled randomized parallel trial with one week treatment followed by one week wash-out. Subjects were randomized into two treatment groups (n?=?10/group) to receive either ferrous sulphate (200 mg capsules containing 65 mg of iron) or placebo, both to be taken at mealtimes twice daily during the treatment period. Subjects completed the questionnaires daily for 14 days. The questionnaire included gastrointestinal symptoms commonly reported to be associated with the oral intake of ferrous iron salts (i.e. nausea, vomiting, heartburn, abdominal pain, diarrhoea, and constipation).Seventy five per cent of participants reporting the presence of one or more symptoms in the first week of the study were in the ferrous sulphate group. In the second week of the study (i.e. wash-out), 67% of the participants reporting one or more symptom(s) were in the ferrous sulphate group. In the first week of the study (treatment) the number of symptoms reported by participants in the ferrous sulphate group (mean?±?SEM?=?6.7?±?1.7) was significantly higher than that for participants in the placebo group (1.2?±?0.5) (p?=?0.01). In the second week of the study (wash-out) the number of symptoms reported by participants in the ferrous sulphate group (4.6?±?2.0) appeared higher than for participants in the placebo group (1.0?±?0.7) although this did not reach significance (p?=?0.12). Events for which the gastrointestinal symptom questionnaire was most discriminatory between ferrous sulphate and placebo groups were: heartburn, abdominal pain and the presence of black stools (all p???0.03).A tool for the detection of commonly-occurring side effects should not require large study numbers to be effective. With just 10 subjects per group (iron or placebo), this simple questionnaire measures gastrointestinal side-effects associated with oral iron (ferrous sulphate) supplementation, and would be appropriate for use in intervention studies or clinical trials.ClinicalTrials.gov Identifier: NCT02146053 (21/05/2014).

SUBMITTER: Pereira DI

PROVIDER: S-EPMC4082414 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A rapid, simple questionnaire to assess gastrointestinal symptoms after oral ferrous sulphate supplementation.

Pereira Dora I A DI Couto Irving Susana S SS Lomer Miranda C E MC Powell Jonathan J JJ

BMC gastroenterology 20140604

<h4>Background</h4>Oral iron supplementation is often associated with rapid onset of gastrointestinal side-effects. The aim of this study was to develop and trial a short, simple questionnaire to capture these early side-effects and to determine which symptoms are more discriminating.<h4>Methods</h4>The study was a double-blind placebo-controlled randomized parallel trial with one week treatment followed by one week wash-out. Subjects were randomized into two treatment groups (n = 10/group) to r ...[more]

PMID: 24899360

Similar Datasets

Project description:BackgroundExercise induced gastrointestinal (GI) symptoms can plague athletes, especially runners. Sport nutrition recommendations are nutrient rather than foods focused and do not adequately address strategies to reduce GI symptoms. The objective was to develop a valid and reliable questionnaire to evaluate pre-training and pre-racing voluntary food restrictions/choices, reasons for avoiding foods, and gastrointestinal symptoms in endurance runners.MethodsValidity testing occurred through four Registered Dietitians, three of whom possess Master's degrees, and a dietetic trainee who provided initial feedback. Additionally, one Registered Dietitian is a Board Certified Specialist in Sports Dietetics (CSSD), and another has an International Olympic Committee Diploma in Sports Nutrition. The second version was sent out to nine different experts who rated each question using a Likert scale and provided additional comments. For reliability testing, the questionnaire was administered to 39 participants in a test re-test format. Kappa statistics and the prevalence-adjusted bias-adjusted kappa (PABAK) were used to assess the reliability.ResultsAll questions had an average Likert scale rating of 4/5 or greater. All test re-test results falling under basic information exhibited substantial agreement (kappa ≥0.61). All medical questions including food allergies and intolerances had moderate (kappa ≥0.41) or higher agreement. Responses were less consistent for food avoidances while training (5/28 outcomes) versus racing (0/28 outcomes) with a kappa below 0.41. All reasons for avoiding foods were deemed reliable. Regarding symptoms, side stitch while training and gas while racing were the only flagged categories.ConclusionsOverall, the questionnaire is a valid and reliable tool to evaluate voluntary dietary restrictions among endurance runners. Future studies can use the questionnaire to assess dietary strategies runners employ to reduce GI distress and optimize performance.

Project description:After radiotherapy for pelvic cancer, chronic gastrointestinal problems may affect quality of life (QOL) in 6-78% of patients. This variation may be due to true differences in outcome in different diseases, and may also represent the inadequacy of the scales used to measure radiotherapy-induced gastrointestinal side effects. The aim of this study was to assess whether outcome measures used for nonmalignant gastrointestinal disease are useful to detect gastrointestinal morbidity after radiotherapy. Results obtained from a Vaizey Incontinence questionnaire and a modified Inflammatory Bowel Disease questionnaire (IBDQ)--both patient completed--were compared to those from a staff administered Late Effects on Normal Tissue (LENT)--Subjective, Objective, Management and Analytic (SOMA) questionnaire in patients who had completed radiotherapy for a pelvic tumour at least 3 months previously. In all, 142 consecutive patients were recruited, 72 male and 70 female, median age 66 years (range 26-90 years), a median of 27 (range 3-258) months after radiotherapy. In total, 62 had been treated for a gynaecological, 58, a urological and 22, a gastrointestinal tract tumour. Of these, 21 had undergone previous gastrointestinal surgery and seven suffered chronic gastrointestinal disorders preceding their diagnosis of cancer. The Vaizey questionnaire suggested that 27% patients were incontinent for solid stools, 35% for liquid stools and 37% could not defer defaecation for 15 min. The IBDQ suggested that 89% had developed a chronic change in bowel habit and this change significantly affected 49% patients: 44% had more frequent or looser bowel movements, 30% were troubled by abdominal pain, 30% were troubled by bloating, 28% complained of tenesmus, 27% were troubled by their accidental soiling and 20% had rectal bleeding. At least 34% suffered emotional distress and 22% impairment of social function because of their bowels. The small intestine/colon SOMA median score was 0.1538 (range 0-1) and the rectal SOMA median score was 0.1428 (range 0-1). Pearson's correlations for the IBDQ score and small intestine/colon SOMA score was -0.630 (P<0.001), IBDQ and rectum SOMA -0.616 (P<0.001), IBDQ and Vaizey scores -0.599 (P<0.001), Vaizey and small intestine/colon SOMA 0.452 (P<0.001) and Vaizey and rectum SOMA 0.760 (P<0.001). After radiotherapy for a tumour in the pelvis, half of all patients develop gastrointestinal morbidity, which affects their QOL. A modified IBDQ and Vaizey questionnaire are reliable in assessing new gastrointestinal symptoms as well as overall QOL and are much easier to use than LENT SOMA.

Project description:BackgroundBowel symptoms are considered indicators of the presence of colorectal cancer and other bowel diseases. Self administered questionnaires that elicit information about lower bowel symptoms have not been assessed for reliability, although this has been done for upper bowel symptoms. Our aim was to develop a self administered questionnaire for eliciting the presence, nature and severity of lower bowel symptoms potentially related to colorectal cancer, and assess its reliability.MethodsImmediately before consulting a gastroenterologist or colorectal surgeon, 263 patients likely to have a colonoscopy completed the questionnaire. Reliability was assessed in two ways: by assessing agreement between patient responses and (a) responses given by the doctor at the consultation; and (b) responses given by patients two weeks later.ResultsThere was more than 75% agreement for 78% of the questions for the patient-doctor comparison and for 92% of the questions for the patient-patient comparison. Agreement for the length of time a symptom was present, its severity, duration, frequency of occurrence and whether or not medical consultation had been sought, all had agreement of greater than 70%. Over all questions, the chance corrected agreement for the patient-doctor comparison had a median kappa of 65% (which represents substantial agreement), interquartile range 57-72%. The patient-patient comparison also showed substantial agreement with a median kappa of 75%, interquartile range 68-81%.ConclusionThis self administered questionnaire about lower bowel symptoms is a useful way of eliciting details of bowel symptoms. It is a reliable instrument that is acceptable to patients and easily completed. Its use could guide the clinical consultation, allowing a more efficient, comprehensive and useful interaction, ensuring that all symptoms are assessed. It will also be a useful tool in research studies on bowel symptoms and their predictive value for colorectal cancer and other diseases. Studies assessing whether bowel symptoms predict the presence of colorectal cancer should provide estimates of the reliability of the symptom elicitation.

Dataset Information

A rapid, simple questionnaire to assess gastrointestinal symptoms after oral ferrous sulphate supplementation.

Publications

A rapid, simple questionnaire to assess gastrointestinal symptoms after oral ferrous sulphate supplementation.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets