Robyn T. Carson
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View article: From clinical trials to informing clinical decision-making: a review of patient-reported outcomes in nononcology medicines approved by the European Medicines Agency (2018–2022)
From clinical trials to informing clinical decision-making: a review of patient-reported outcomes in nononcology medicines approved by the European Medicines Agency (2018–2022) Open
Introduction Information about a medicine published in the Summary of Product Characteristics (SmPC) and the product’s package leaflet by the European Medicines Agency (EMA) is key to communicate its value to prescribers and patients. The …
View article: A Review of Patient-Reported Outcome Labeling of FDA-Approved New Drugs (2016-2020): Counts, Categories, and Comprehensibility
A Review of Patient-Reported Outcome Labeling of FDA-Approved New Drugs (2016-2020): Counts, Categories, and Comprehensibility Open
The increase in labeling text based on PRO endpoints in product labels is encouraging. However, there is room for improvement on the comprehensibility of labeling statements based on PRO endpoints.
View article: coreNASH: Multi-stakeholder Consensus on Core Outcomes for Decision Making About Nonalcoholic Steatohepatitis Treatment
coreNASH: Multi-stakeholder Consensus on Core Outcomes for Decision Making About Nonalcoholic Steatohepatitis Treatment Open
The increasing prevalence and burden of nonalcoholic steatohepatitis (NASH) has spurred the development of new treatments and a need to consider outcomes used for NASH treatment decision making. Development of a NASH core outcome set (COS)…
View article: Comprehensive assessment of patients with irritable bowel syndrome with constipation and chronic idiopathic constipation using deterministically linked administrative claims and patient-reported data: the Chronic Constipation and IBS-C Treatment and Outcomes Real-World Research Platform (CONTOR)
Comprehensive assessment of patients with irritable bowel syndrome with constipation and chronic idiopathic constipation using deterministically linked administrative claims and patient-reported data: the Chronic Constipation and IBS-C Treatment and Outcomes Real-World Research Platform (CONTOR) Open
By combining administrative claims and patient-reported data over time, CONTOR afforded a deeper understanding of the IBS-C/CIC patient experience than could be achieved with 1 data source alone; for example, participants self-reported bur…
View article: Psychometric Analysis of the Abdominal Score From the Diary for Irritable Bowel Syndrome Symptoms–Constipation Using Phase IIb Clinical Trial Data
Psychometric Analysis of the Abdominal Score From the Diary for Irritable Bowel Syndrome Symptoms–Constipation Using Phase IIb Clinical Trial Data Open
Overall, this study provides evidence that the DIBSS-C abdominal score is valid, reliable, responsive to change, and interpretable for assessing treatment benefit in patients with IBS-C.
View article: The Impact of Stool Consistency on Bowel Movement Satisfaction in Patients With IBS-C or CIC Treated With Linaclotide or Other Medications
The Impact of Stool Consistency on Bowel Movement Satisfaction in Patients With IBS-C or CIC Treated With Linaclotide or Other Medications Open
Goals: This study aimed to characterize the impact of stool consistency on patient-reported bowel movement (BM) satisfaction in patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation, with a foc…
View article: Su1587 – New Patient Reported Outcome Measure: Diary for Irritable Bowel Syndrome Symptoms—Constipation, Guidelines for Interpretation of Change in Abdominal Symptoms Using Phase 2B Clinical Trial Data
Su1587 – New Patient Reported Outcome Measure: Diary for Irritable Bowel Syndrome Symptoms—Constipation, Guidelines for Interpretation of Change in Abdominal Symptoms Using Phase 2B Clinical Trial Data Open
View article: <p>Development and psychometric evaluation of the Diabetic Gastroparesis Symptom Severity Diary</p>
Development and psychometric evaluation of the Diabetic Gastroparesis Symptom Severity Diary Open
Qualitative and quantitative evidence support use of the DGSSD as a reliable and valid measure from which to derive endpoints to evaluate treatment benefit in future DG interventional trials.
View article: The impact of treatment with eluxadoline on health-related quality of life among adult patients with irritable bowel syndrome with diarrhea
The impact of treatment with eluxadoline on health-related quality of life among adult patients with irritable bowel syndrome with diarrhea Open
Compared to placebo, twice-daily eluxadoline treatment significantly improved HRQOL among patients with IBS-D in two phase III trials.
View article: Development of a Symptom-Focused Patient-Reported Outcome Measure for Functional Dyspepsia: The Functional Dyspepsia Symptom Diary (FDSD)
Development of a Symptom-Focused Patient-Reported Outcome Measure for Functional Dyspepsia: The Functional Dyspepsia Symptom Diary (FDSD) Open
The FDSD is a content-valid PRO measure, with preliminary psychometric evidence providing support for the FDSD's items and total score. Further psychometric evaluations are recommended to more fully test the FDSD's score performance and ot…
View article: Development of the Diary for Irritable Bowel Syndrome Symptoms to Assess Treatment Benefit in Clinical Trials: Foundational Qualitative Research
Development of the Diary for Irritable Bowel Syndrome Symptoms to Assess Treatment Benefit in Clinical Trials: Foundational Qualitative Research Open
View article: Health-related quality of life, work productivity, and indirect costs among patients with irritable bowel syndrome with diarrhea
Health-related quality of life, work productivity, and indirect costs among patients with irritable bowel syndrome with diarrhea Open
View article: Development of a Symptom-Based Patient-Reported Outcome Instrument for Functional Dyspepsia: A Preliminary Conceptual Model and an Evaluation of the Adequacy of Existing Instruments
Development of a Symptom-Based Patient-Reported Outcome Instrument for Functional Dyspepsia: A Preliminary Conceptual Model and an Evaluation of the Adequacy of Existing Instruments Open