Dataset Information

The content validity of the ANMS GCSI-DD in patients with idiopathic or diabetic gastroparesis.

ABSTRACT: BACKGROUND:The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) was developed to meet Food and Drug Administration (FDA) recommendations for patient-reported outcome (PRO) endpoints in gastroparesis studies, including therapeutic trials. The current version of the ANMS GCSI-DD contains five items pertaining to nausea, early satiety, post-prandial fullness, upper abdominal pain, and vomiting. The specific aims of this study were to determine if the appropriate symptoms are included in the ANMS GCSI-DD and to assess the content validity in patients with idiopathic (IG) and diabetic gastroparesis (DG). METHODS:Patients diagnosed with IG or DG were recruited by five clinical sites in the United States for a cross-sectional, qualitative study involving one-on-one in-person concept elicitation and cognitive debriefing interviews. Concept elicitation included open-ended questions to elicit patients' symptoms and impacts of gastroparesis, while cognitive debriefing was designed to assess the comprehensiveness of the ANMS GCSI-DD and clarity of the instructions, items, and response scales. The interviews were audio-recorded and transcribed. Transcripts were analyzed using a content analysis approach with ATLAS.ti. RESULTS:Of 25 patients interviewed, 15 (60%) had IG and 10 (40%) DG. Mean age of the sample was 42.3 years (range: 20-70 years), and most patients were female (n?=?19, 76%) and white (n?=?19, 76%). During concept elicitation, patients endorsed the following signs and symptoms as relevant and important to their condition: early satiety (n?=?25, 100%), post-prandial fullness (n?=?25, 100%), nausea (n?=?22, 88%), upper abdominal pain (n?=?18, 72%), vomiting (n?=?15, 60%), and bloating (n?=?11, 44%). Many patients (n?=?20, 80%) experienced day-to-day symptom change. During cognitive debriefing, patients confirmed the ANMS GCSI-DD content was comprehensive and reflective of their gastroparesis experience. Patients could easily select a response option and describe how they arrived at their answers. Overall, patients found the instrument's instructions, recall period, items, and response options clear and understandable. CONCLUSIONS:The ANMS GCSI-DD was easily understood, found to contain the most important symptoms for patients with IG and DG, and no changes were recommended. Results support the content validity of the ANMS GCSI-DD for clinical trials and clinical care among IG or DG patients.

SUBMITTER: Revicki DA

PROVIDER: S-EPMC6292831 | biostudies-other | 2018 Dec

REPOSITORIES: biostudies-other

ACCESS DATA

Publications

The content validity of the ANMS GCSI-DD in patients with idiopathic or diabetic gastroparesis.

Revicki Dennis A DA Lavoie Sara S Speck Rebecca M RM Puelles Jorge J Kuo Braden B Camilleri Michael M Almansa Cristina C Parkman Henry P HP

Journal of patient-reported outcomes 20181213 1

<h4>Background</h4>The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) was developed to meet Food and Drug Administration (FDA) recommendations for patient-reported outcome (PRO) endpoints in gastroparesis studies, including therapeutic trials. The current version of the ANMS GCSI-DD contains five items pertaining to nausea, early satiety, post-prandial fullness, upper abdominal pain, and vomiting. The specific aims of this stud ...[more]

PMID: 30547386

Similar Datasets

Project description:BackgroundDengue is the most prevalent arboviral infection causing an estimated 50-60 million cases of febrile illness globally per year, exacting considerable disease burden. Few instruments exist to assess the patient illness experience, with most based on healthcare provider assessment, lacking standardization in timepoints and symptom assessment. This study aimed to evaluate the content validity of the novel 'Dengue Virus Daily Diary (DENV-DD)', designed to measure symptom intensity and disease burden within outpatient infant to adult populations.MethodsThe Dengue Illness Index Report Card was used as a foundation to create the DENV-DD, consisting of patient- and observer-reported outcome (PRO/ObsRO) instruments. In two South American dengue-endemic communities, qualitative combined concept elicitation and cognitive debriefing interviews were conducted among individuals and caregivers of children with symptomatic laboratory-confirmed dengue. Interviews were conducted across two rounds allowing DENV-DD modifications. A small-scale quantitative assessment of the DENV-DD was also conducted with data from an independent Dengue Human Infection Model (DHIM) to generate early evidence of feasibility of DENV-DD completion, instrument performance and insight into the sign/symptom trajectory over the course of illness.ResultsForty-eight participants were interviewed (20 adults, 20 older children/adolescents with their caregivers, 8 caregivers of younger children). A wide spectrum of signs/symptoms lasting 3-15 days were reported with fever, headache, body ache/pain, loss of appetite, and body weakness each reported by > 70% participants. DENV-DD instructions, items and response scales were understood, and items were considered relevant across ages. DHIM data supported feasibility of DENV-DD completion.ConclusionsFindings demonstrate content validity of the DENV-DD (PRO/ObsRO instruments) in dengue-endemic populations. Psychometric and cultural validity studies are ongoing to support use of the DENV-DD in clinical studies.

Project description:Aim: Diabetic peripheral neuropathy (DPN) is a common, severe microvascular complication of diabetes. Our study was to assess prevalence and risk factors for DPN in subjects with type 2 diabetes from 14 different countries. Methods: A total of 2,733 subjects with type 2 diabetes aged 18-65 years (45.3% men, mean duration of diabetes = 8.8 years) were included to perform this International Prevalence and Treatment of Diabetes and Depression (INTERPRET-DD) study in 14 countries. After a structured questionnaire was used in face-to-face interviews to collect sociodemographic characteristics and medical records of the participating subjects, laboratory tests were carried out for clinical measurement. Depressive symptoms were diagnosed and measured using the Patient Health Questionnaire-9. The potential risk factors for DPN were determined by multilevel mixed-effects logistic regression, accounting for clustering of participants within the country. Robustness of the estimates was assessed by sensitivity analysis. Results: The overall prevalence of DPN across different countries was 26.71%, whereas country-specific prevalences showed considerable variation. Multivariate analysis revealed that duration of diabetes (OR: 1.08 per 1-year increase, 95% CI: 1.06-1.09), poor glycemic control (OR: 1.11 per 1% increase in HbA1c, 95% CI: 1.05-1.18), and history of hypertension (OR: 1.58, 95% CI: 1.18-2.12), cardiovascular disease (OR: 2.07, 95% CI: 1.55-2.78) and depressive symptoms (OR: 1.92, 95% CI: 1.43-2.58) were independently and positively associated with the risk of DPN. Sensitivity analyses including or excluding patients from countries with extreme low or high prevalence of DPN yielded similar estimates in terms of trend and magnitude. Conclusions: This international study illustrates that more than a quarter of individuals with type 2 diabetes developed DPN. The prevalence was positively associated with the duration of diabetes, poor glycemic control, and history of hypertension, cardiovascular disease and depressive symptoms.

Project description:BackgroundCurrently, there are no outcome measures assessing the ability of people with non-specific low back pain to self-manage their illness. Inspired by the 'Patient Enablement Instrument', we developed the Patient Enablement Instrument for Back Pain (PEI-BP). The aim of this study was to describe the development of the Patient Enablement Instrument for Back Pain (PEI-BP) and investigate content validity, construct validity, internal consistency, test-retest reliability, measurement error, responsiveness and floor and ceiling effects.MethodsThe PEI-BP consists of 6 items that are rated on a 0-10 Numeric Rating Scale. Measurement properties were evaluated using the COSMIN taxonomy and were based on three cohorts from primary care with low back pain: The content validity cohort (N = 14) which participated in semi-structured interviews, the GLA:D® Back cohort (N = 272) and the test-retest cohort (N = 37) which both completed self-reported questionnaires. For construct validity and responsiveness, enablement was compared to disability (Oswestry Disability Index), back pain beliefs (Brief Illness Perception Questionnaire), fear avoidance (Fear-Avoidance Beliefs Questionnaire-physical activity), mental health (SF-36), educational level and number of previous episodes of low back pain.ResultsThe PEI-BP was found to have acceptable content validity, construct validity, reliability (internal consistency, test-retest reliability and measurement error) and responsiveness. The Smallest Detectable Change was 10.1 points illustrating that a patient would have to change more than 1/6 of the scale range for it to be a true change. A skewed distribution towards the high scores were found at baseline indicating a potentially problematic ceiling effect in the current population.ConclusionsThe PEI-BP can be considered a valid and reliable tool to measure enablement on people seeking care for non-specific LBP. Further testing of the PEI-BP in populations with more severe LBP is recommended.Trial registrationNot applicable.

Project description:PurposeWe evaluate the face, content, and construct validity of a portable hip arthroscopy module in a regional orthopaedic unit.MethodsParticipants were recruited from a regional orthopaedic centre, and categorized into novice (0 arthroscopies), intermediate (1-29 arthroscopies), and expert (>50 arthroscopies) groups based on reported experience in arthroscopy. Face and content validity was evaluated by feedback from users immediately following completion of modules. Objective measurements, including time taken and subjective measurements consisting of simulation software metrics including, cam lesion locations attempts, scope strikes on bone, healthy bone burred, and cam lesion burred. Scores achieved by experts were recorded, and the median score was set at the level at which proficiency was demonstrated. Participant feedback on perceived educational use was collected following completion.ResultsIn total, 20 participant results were included for analysis. Good face and content validity was expressed by participants with previous arthroscopic experience. Number of scope strikes within the simulator-derived metrics accurately discerned between levels of experience. Novices had a mean of 5 strikes per attempt (SD ±5), intermediates a mean of 5.8 strikes (SD ± 4.1). There was a significant difference between expert and novice groups (P = .01), and expert and intermediate groups (P = .002). No significant difference between overall performance scores achieved by participants in expert, intermediate, and novice groups (62% ±19 vs 55% ±22 vs 50% ±23, P = .15). This demonstrates incomplete construct validity of the simulator software-derived metrics.ConclusionsThis hip arthroscopy simulator demonstrated acceptable face and content validity, with incomplete construct validity of simulator software metrics. Participants reported high levels of satisfaction with the module, highlighting that the addition of haptic feedback would be beneficial to improve procedural steps. Incorporation of tactile feedback to the modulator components would likely enable the software to accurately delineate between levels of experience.Clinical relevanceThis study demonstrates good face and content validity. The addition of haptic feedback in a hip arthroscopy simulator may improve learning.

Project description:Study designOutcome investigation to verify the internal consistency, reproducibility and validity of the adapted Chinese version of the Scoliosis Research Society-22 (SRS-22) questionnaire for measuring health-related quality of life (HRQoL) in children with idiopathic scoliosis.ObjectiveTo develop this questionnaire for the outcome measurement in treating Chinese adolescents with idiopathic scoliosis and evaluate its metric qualities. The SRS-22 questionnaire has proven to be a valid instrument for clinical assessment of patients with idiopathic scoliosis and has been successfully translated into Spanish and Turkish. In most developing countries, however, quality of life and psychological health have been poorly described when treating children with idiopathic scoliosis.MethodsTrans-cultural adaptation of the SRS-22 questionnaire was carried out according to the International Quality of Life Assessment Project guidelines. The final version was approved by a committee of experts. The questionnaire was completed by 86 adolescents with idiopathic scoliosis who had been treated with a brace; this included 11 males and 75 females, aged from 10 to 18 years (mean 13.9 years). Curve magnitude ranged from 25 degrees to 45 degrees (mean 35.6 degrees ). A subgroup of 30 patients completed the questionnaire again in 3 or 4 weeks.ResultsFive common factors were acquired from factorial analysis, and the cumulative contribution ratio was 67.66%. The overall alpha coefficient of the questionnaire was 0.88. Coefficients for individual domains were as follows: function/activity, 0.70; pain, 0.80; self-image, 0.80; mental health, 0.88; and satisfaction, 0.81. The questionnaire as a whole had a test-retest correlation coefficient of 0.97. Test-retest correlation coefficients for individual domains were as follows: function, 0.85; pain, 0.96; self-image, 0.96; mental health, 0.95; and satisfaction, 0.91.ConclusionThe Chinese version of the SRS-22 questionnaire is eligible in terms of reliability and validity, and can be used to measure HRQoL for adolescent idiopathic scoliosis patients in Mainland China.

Dataset Information

The content validity of the ANMS GCSI-DD in patients with idiopathic or diabetic gastroparesis.

Publications

The content validity of the ANMS GCSI-DD in patients with idiopathic or diabetic gastroparesis.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets