Publications by authors named "Robyn T Carson"
Leveraging sensor-based functional outcomes to enhance understanding of the patient experience: challenges and opportunities.
Expert Rev Pharmacoecon Outcomes Res
July 2024
Article Synopsis
- - Sensor-based digital health technology (DHT) uses sensors to improve understanding of patient health by providing data on functioning both in and out of clinical trials, enhancing the patient experience for medical product development.
- - The paper outlines recommendations for defining sensor-based functional outcomes (SBFOs), the necessary evidence to support their use in decision-making, and future directions for this emerging field.
- - Successful SBFO development relies on a combination of expertise in patient engagement, measurement science, and analytics, while addressing challenges such as identifying meaningful health concepts and establishing thresholds for change, making SBFOs valuable alongside traditional clinical outcome assessments.
Article Synopsis
- The study aimed to assess the reliability and validity of the Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C) for measuring symptoms in IBS with constipation.
- Data was gathered from 108 adults over 17 days using a smartphone device, evaluating bowel movements and abdominal symptoms through various scales.
- The findings showed high consistency and reliability in measuring abdominal symptoms, with strong correlations supporting the DIBSS-C's effectiveness, helping to qualify it for use in IBS-C clinical trials by the FDA.
Article Synopsis
- A study reviewed new drug approvals by the FDA from 2016 to 2020, focusing on patient-reported outcomes (PROs) in labeling, finding that 26.3% of drugs included PRO-based statements.
- Compared to previous years (2006-2015), the percentage of NDAs with PRO labeling has increased in both PRO-dependent and non-PRO-dependent categories.
- Despite the rise in PRO-based labeling, more than half of these statements were deemed complex, highlighting the need for clearer communication in drug labels.
Article Synopsis
- The study aims to analyze the experiences of patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) by linking claims data with patient-reported outcomes using the CONTOR platform.
- Data was collected through surveys and diaries over a year, examining symptom severity, treatment approaches, quality of life, and healthcare costs from a sample of 2,052 participants.
- Findings revealed many patients experienced significant symptoms and treatment dissatisfaction, particularly among those on multiple treatments, signaling the need for improved strategies in managing these conditions.
Article Synopsis
- The study evaluates the Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C) to measure key symptoms of IBS-C, focusing on its abdominal score.
- Findings show strong correlations among abdominal symptom items, high reliability (Cronbach's alpha of .94), and good test-retest reliability (0.82).
- The DIBSS-C abdominal score is responsive to changes, with a threshold of -2.0 points indicating clinically meaningful improvements for patients with IBS-C.*
Article Synopsis
- The study aimed to investigate how stool consistency affects bowel movement satisfaction in patients with IBS-C or chronic constipation, focusing on the medication linaclotide.
- Data was collected from 2922 daily bowel movement diaries, analyzing the relationship between stool types (loose, hard, or intermediate) and patient satisfaction.
- Results showed that intermediate and loose stools were reported as satisfactory more often, with linaclotide users more likely to report satisfaction, especially with loose stools.
Article Synopsis
- - Diabetic gastroparesis (DG) is characterized by delayed stomach emptying and specific gastrointestinal symptoms, and the Diabetic Gastroparesis Symptom Severity Diary (DGSSD) was created to better measure and assess these patient-reported symptoms for treatment evaluation.
- - The development of the DGSSD involved qualitative research with 41 patients and resulted in a six-item tool focusing on symptoms like nausea, vomiting, and bloating, which was further enhanced based on regulatory feedback to include postprandial fullness.
- - Psychometric analysis demonstrated that the DGSSD has strong measurement properties, making it a reliable tool for determining treatment effectiveness in clinical trials for DG.
Article Synopsis
- The study aimed to evaluate how eluxadoline treatment affects health-related quality of life (HRQOL) in patients with irritable bowel syndrome with diarrhea (IBS-D).
- Adult patients were randomly assigned to take eluxadoline or a placebo, with their HRQOL assessed using the IBS-QOL questionnaire over 26 to 52 weeks.
- Results showed significant improvements in HRQOL scores for those on eluxadoline compared to the placebo group, indicating that the treatment is effective for enhancing quality of life for IBS-D patients.
Article Synopsis
- - Pharmacy costs rose due to the introduction of a new treatment in a market where over-the-counter and generic options are common.
- - Despite the increase in pharmacy costs, there was a significant decrease in healthcare resource use and costs related to gastrointestinal issues and irritable bowel disease.
- - This decrease in costs was observed among both commercial and Medicare patients after they started treatment with linaclotide.
Article Synopsis
- The Functional Dyspepsia Symptom Diary (FDSD) was created to fill the gap in effective symptom-focused, patient-reported outcome measures for people with functional dyspepsia (FD), aligning with FDA guidelines.
- Researchers conducted interviews with FD patients to identify key symptoms, leading to the development of the FDSD, which was then tested for usability and effectiveness through cognitive interviews.
- Results showed that the FDSD is valid and reliable, capturing important symptoms without redundancy, but further testing is needed to fully validate its measurement properties.
Article Synopsis
- Irritable bowel syndrome (IBS) is a chronic digestive disorder with three subtypes based on stool patterns: diarrhea-predominant, constipation-predominant, and mixed IBS.
- The study aimed to create patient-reported outcome measures for IBS that the FDA could qualify, using qualitative interviews to gather data from IBS patients meeting specific criteria.
- Findings highlighted that symptom importance varied by IBS subtype, leading to refined measures and a pilot study set to enhance scoring and validate the outcomes further.
Article Synopsis
- Irritable bowel syndrome with diarrhea (IBS-D) affects 10-15% of adults in the US and significantly reduces their health-related quality of life (HRQoL), work productivity, and daily activities, but there's a lack of specific data about this subtype.
- A study analyzed data from 66,491 respondents, showing that those with IBS-D had notably lower mental and physical health scores compared to controls, as well as higher rates of absenteeism and presenteeism.
- The results suggest that IBS-D not only impacts personal health but also leads to increased indirect costs due to productivity losses at work and diminishes overall quality of life.
Article Synopsis
- The study aimed to document the main symptoms of functional dyspepsia (FD), evaluate how well existing questionnaires capture those symptoms, and identify any gaps affecting their use in clinical trials for treatment efficacy claims.
- A literature review identified 56 articles and 16 patient-reported outcome (PRO) instruments, which were compared to Rome III criteria and FDA guidelines.
- Only three questionnaires fully covered the seven FD symptoms outlined in the Rome III criteria, yet they still had issues that might prevent them from meeting regulatory standards for clinical trials.
Article Synopsis
- A study evaluated linaclotide (Linzess) and lubiprostone (Amitiza) for treating chronic idiopathic constipation (CIC) in adults, focusing on effectiveness and costs.
- The research used a decision-tree model based on trial data and surveys to compare treatment outcomes, with key measures including patient satisfaction and spontaneous bowel movement frequency at 4 weeks.
- Results showed linaclotide had lower costs and similar effectiveness compared to lubiprostone, making it a potentially better option for treating CIC in adults.
Comparison of adequate relief with symptom, global, and responder endpoints in linaclotide phase 3 trials in IBS-C.
United European Gastroenterol J
February 2015
Article Synopsis
- The article investigates the effectiveness of "adequate relief" (AR) as a clinical trial endpoint for IBS-C and how it compares to other established endpoints like FDA and EMA criteria.
- It analyzes data from two phase 3 clinical trials involving linaclotide over 12 weeks to determine correlations between AR and abdominal symptoms, bowel symptoms, and global health assessments.
- The study concludes that AR serves as a consistent measure that aligns with FDA and EMA responder criteria, helping to standardize IBS-C trial outcomes and improve comparisons across studies.
Article Synopsis
- The study aimed to assess the effectiveness and costs of linaclotide versus lubiprostone in treating adults with irritable bowel syndrome with constipation (IBS-C) through a decision-analytic model.
- Results showed that linaclotide led to a higher percentage of treatment responders, lower costs per patient, and greater quality-adjusted life-years (QALYs) compared to lubiprostone over a 12-week period.
- Limitations of the study include the lack of direct head-to-head trials and the short time frame of the model, which only reflects available clinical trial data.
Article Synopsis
- The study analyzed the effectiveness of patient-reported outcome measures for chronic constipation (CC) in clinical trials of linaclotide, highlighting that previous measures fell short of FDA standards.
- Using data from multiple trials, the researchers assessed the measurement properties of CC Symptom Severity Measures, confirming their reliability and validity through various statistical analyses.
- Results showed that linaclotide significantly improved both abdominal and bowel symptoms in CC patients, supporting the effectiveness of the analyzed measures for evaluating treatment outcomes in clinical studies.
Article Synopsis
- Irritable bowel syndrome with constipation (IBS-C) is a chronic condition that impacts both work productivity and daily life, creating challenges for patients and employers.
- Linaclotide, a medication approved for IBS-C, was studied for its effects on work and activity impairment through two phase 3 clinical trials.
- Results indicated that linaclotide significantly improved work productivity and reduced daily activity limitations in patients with IBS-C, showing a notable decrease in presenteeism and overall productivity loss compared to a placebo.
Article Synopsis
- The study focuses on the need for effective clinical outcome assessments (COAs) in trials regarding pediatric chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C).
- A literature review including 1,105 abstracts identified a limited number of relevant studies and COAs that measure key symptoms such as bowel movement frequency, abdominal pain, and stool consistency in children.
- Although there is general agreement among experts on important symptoms to measure, the existing COAs fall short of regulatory standards for proper evaluation in clinical trials.
Assessment of treatment response in chronic constipation clinical trials.
Clin Exp Gastroenterol
June 2014
Article Synopsis
- Research highlights that chronic constipation (CC) not only involves bowel symptoms but also significant abdominal symptoms experienced by patients.
- A study involving literature reviews and patient interviews identified a range of symptoms important for clinical trials, discovering 62 distinct symptoms related to CC.
- Findings emphasize that both bowel and abdominal symptoms are crucial for understanding patient experiences and should be included in clinical trial assessments to evaluate treatment benefits effectively.
Article Synopsis
- - The study aimed to compare healthcare resource utilization (HRU) and costs for adults with irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC), differentiating those who experienced treatment failure from those who did not.
- - Using Missouri Medicaid claims data, researchers found that about 50% of patients had indicators of treatment failure, which led to significantly higher healthcare resource usage and costs, with annual costs rising by $4,353 for IBS-C patients and $2,978 for CC patients.
- - Limitations include that the study only involved Medicaid patients in Missouri, and the reliance on claims data may affect the accuracy in identifying treatment failure.
Article Synopsis
- - The study examines the prevalence and associated health care costs of irritable bowel syndrome with constipation (IBS-C), affecting 4.3% to 5.2% of U.S. adults, aiming to assess total costs in individuals seeking medical care and compare these costs to matched controls.
- - Researchers utilized a large database to identify IBS-C patients and controls, ensuring accurate comparison by matching on age, gender, and health plan characteristics, while excluding those with certain other diagnoses.
- - Findings were focused on calculating annual health care costs related to IBS-C, including expenses from various medical services and prescriptions, providing insight into the financial impact of this condition.
Objective: To evaluate total annual all-cause, gastrointestinal-related, and symptom-related healthcare costs among chronic constipation (CC) patients and estimate incremental all-cause healthcare costs of CC patients relative to matched controls.
Methods: Patients aged ≥18 years with continuous medical and pharmacy benefit eligibility in 2010 were identified from the HealthCore Integrated Research Database. CC patients had ≥2 medical claims for constipation (ICD-9-CM code 564.
Background: Irritable bowel syndrome (IBS) and chronic constipation (CC) are common functional gastrointestinal disorders affecting 14% and 20% of the U.S. population, respectively.
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