Optimizing Therapeutic Outcomes With Oral Semaglutide: A Patient-Centered Approach.
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SUBMITTER: Isaacs DM
PROVIDER: S-EPMC7887531 | biostudies-literature | 2021 Jan
REPOSITORIES: biostudies-literature
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Optimizing Therapeutic Outcomes With Oral Semaglutide: A Patient-Centered Approach.
Isaacs Diana M DM Kruger Davida F DF Spollett Geralyn R GR
Diabetes spectrum : a publication of the American Diabetes Association 20210101 1
In September 2019, the U.S. Food and Drug Administration approved oral semaglutide as the first orally administered glucagon-like peptide 1 (GLP-1) receptor agonist for treating people with type 2 diabetes. Although injectable GLP-1 receptor agonists are well-established treatment options for people with type 2 diabetes, clinical experience with an oral formulation in this class is limited. This article provides practical guidance for diabetes care and education specialists on how to effectively ...[more]
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Project description:Introduction/objectivesThe engagement of patients and other stakeholders is a critical element in the design of patient-centered outcomes research studies. However, methodology for scalable engagement in research management particularly activities such as operationalization of principles and setting of priorities is not well-developed. The objective of this study is to describe a novel approach for scalable stakeholder engagement in research aligned with the Patient-Centered Outcomes Research Institute (PCORI) engagement principles, which was evaluated in a national clinical data research network.Materials and methodsPatient, patient advocate, clinician, and researcher stakeholders were recruited from clinical sites, as well as social media sites related to the 3 conditions of focus, heart failure, obesity, and Kawasaki disease. The engagement strategy was designed, implemented, and mapped to the PCORI engagement principles. Evaluation included internal assessment and quantitative measures of online engagement.ResultsWe operationalized the PCORI principles with 12 stakeholder engagement strategies and convened stakeholder advisory boards and online research prioritization panels to determine research priorities in a rigorous, deliberative process. A total of 46 advisors (20 patients) and 339 panelists (159 patients) actively participated. There were not significant differences between patients and clinicians in level of online engagement. Nonetheless, while patients reported a slightly greater challenge with following online discussion, they overall had a more favorable opinion about use of the online format.Discussion/conclusionAn efficient way to engage large numbers of representative stakeholders in research is a necessary first step to assure the public of trustworthy use of data networks for health research. This paper describes a comprehensive approach to engagement in patient-centered outcomes research management that informs ongoing development of rigorous methodologies in this area.
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Project description:The mission of the Patient-Centered Outcomes Research Institute (PCORI) is to fund the production of high-quality evidence that will enable patients and clinicians to make informed, personalized healthcare decisions. Since 2012, the PCORI has invested $177 million in patient-centered comparative effectiveness research (CER) that specifically targets the health needs of older adults, with additional relevant studies in its broader portfolio. Developing the PCORI's research portfolio has provided us with significant insights into what factors to consider when conducting CER in older adult populations. When comparing the net benefit of two or more interventions for older adults, investigators should consider the following: absolute risk difference, competing risks, life expectancy, the difference between chronologic and physiologic age, the importance of patient preferences, and other potential drivers of variable treatment effects. Investigators should also engage older adults and their caregivers as partners throughout the research process. Their input helps to identify key outcomes of interest and insights about the conduct of the research. As the PCORI continues to support research that addresses the healthcare decisions of the rapidly growing older adult population, it needs to partner with patients and researchers to identify the most important questions to address. J Am Geriatr Soc 67:21-28, 2019.
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Project description:ObjectivesThis study explored what smartphone health applications (apps) are used by patients, how they learn about health apps, and how information about health apps is shared.MethodsPatients seeking care in an academic ED were surveyed about the following regarding their health apps: use, knowledge, sharing, and desired app features. Demographics and health information were characterized by summary statistics.ResultsOf 300 participants, 212 (71%) owned smartphones, 201 (95%) had apps, and 94 (44%) had health apps. The most frequently downloaded health apps categories were exercise 46 (49%), brain teasers 30 (32%), and diet 23 (24%). The frequency of use of apps varied as six (6%) of health apps were downloaded but never used, 37 (39%) apps were used only a few times, and 40 (43%) health apps were used once per month. Only five apps (2%) were suggested to participants by health care providers, and many participants used health apps intermittently (55% of apps ≤ once a month). Participants indicated sharing information from 64 (59%) health apps, mostly within social networks (27 apps, 29%) and less often with health care providers (16 apps, 17%).ConclusionsWhile mobile health has experienced tremendous growth over the past few years, use of health apps among our sample was low. The most commonly used apps were those that had broad functionality, while the most frequently used health apps encompassed the topics of exercise, diet, and brain teasers. While participants most often shared information about health apps within their social networks, information was less frequently shared with providers, and physician recommendation played a small role in influencing patient use of health apps.
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Project description:ObjectiveTo explore the effects of oral semaglutide on glycaemic parameters, body weight, and satisfaction in the first recipient patients with type 2 diabetes mellitus in Slovenia, in a real-world clinical practice setting.MethodsThe first consecutive adult patients with type 2 diabetes who were eligible for oral semaglutide treatment were included in this prospective, open-label interventional study. Patients received increasing doses of oral semaglutide and were evaluated at inclusion, at 1 month, then 3-5 months after starting treatment. Fasting blood glucose, glycosylated haemoglobin (HbA1c), body weight, patient satisfaction with oral semaglutide treatment (using the validated Treatment Satisfaction Questionnaire for Medication), and adverse effects, were analysed. Statistical analyses were performed using one-way analysis of variance, and, when significant interactions were found, Bonferroni post-hoc test. A P-value <0.05 was considered statistically significant.ResultsTwenty patients (11 male: 9 female; mean age, 59.9 ± 1.5 years; mean diabetes duration, 8.5 ± 1.4 years) were included. Oral semaglutide (7 and 14 mg) significantly decreased HbA1c (from 9.4 ± 0.3% to 8.2 ± 0.2% and 7.8 ± 0.2%, respectively) and fasting plasma glucose (from 11.2 ± 0.5 mmol/L to 9.2 ± 0.7 mmol/L and 8.9 ± 0.4 mmol/L, respectively). Oral semaglutide (14 mg) significantly decreased body weight (from 100.9 ± 2.7 kg to 92.7 ± 2.4 kg). Patients reported that treatment was easy to use and expressed high global satisfaction. Mild and transient, mostly gastrointestinal, adverse effects were reported in 10 patients.ConclusionsOral semaglutide, the first oral glucagon-like peptide 1 receptor agonist, was effective and safe, and associated with high patient satisfaction, in its first recipients in Slovenia. The results are important for daily clinical practice involving patients with type 2 diabetes, however, due to the small study population, lack of placebo control, and short exposure to oral semaglutide, the effectiveness of oral semaglutide in clinical practice requires further investigation.
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Project description:PurposeThis study presents the validation of an index that defines and measures a patient-centered approach to quality survivorship care.MethodsWe conducted a national survey of 1,278 survivors of breast, prostate, and colorectal cancers to identify their priorities for cancer survivorship care. We identified 42 items that were "very important or absolutely essential" to study participants. We then conducted exploratory and confirmatory factor analyses (EFA/CFA) to develop and validate the Patient-Centered Survivorship Care Index (PC-SCI).ResultsA seven-factor structure was identified based on EFA on a randomly split half sample and then validated by CFA based on the other half sample. The seven factors include: (1) information and support in survivorship (7 items), (2) having a medical home (10 items) (3) patient engagement in care (3 items), (4) care coordination (5 items), (5) insurance navigation (3 items), (6) care transitions from oncologist to primary care (3 items), and (7) prevention and wellness services (5 items). All factors have excellent composite reliabilities (Cronbach's alpha 0.84-0.94, Coefficient of Omega: 0.81-0.94).ConclusionsProviding quality post-treatment care is critical for the long-term health and well-being of survivors. The PC-SCI defines a patient-centered approach to survivorship care to complement clinical practice guidelines. The PC-SCI has acceptable composite reliability, providing the field with a valid instrument of patient-centered survivorship care. The PC-SCI provides cancer centers with a means to guide, measure and monitor the development of their survivorship care to align with patient priorities of care.Trial registrationClinicalTrials.gov ID: NCT02362750 , 13 February 2015.
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Project description:Rationale & objectiveElectronic health record portals are increasingly emphasized in chronic kidney disease (CKD). However, associations of portal use with clinical and patient-centered outcomes remain unknown.Study designCross-sectional survey (April 2015 to March 2018).Setting & participantsNondialysis patients with CKD from nephrology clinics within 1 academic medical center.ExposuresPatient demographics (age, sex, race, ethnicity, education, and income), kidney function.OutcomesAssociation between portal use as an outcome and exposures. Additionally, associations of portal use and patient demographics with 4 patient-centered outcomes (CKD-specific knowledge, stress, and 2 self-ratings of health).Analytic approachLogistic regression to examine associations between patient portal use, demographics, and kidney function. Linear regression to examine associations between portal use and patient-centered outcomes.ResultsOf 245 participants, mean age was 60 ± 17 (SD) years, 182 (77%) were White, 121 (49%) were women, 230 (96%) had a high school education or higher, and 96 (45%) had <$50,000 annual income. Examining portal use, 159 (65%) used the portal as follows: checking laboratory test results, 157 (99%); managing appointments, 133 (84%); messaging providers, 131 (82%); viewing medical history, 127 (80%); reviewing educational resources, 113 (71%); and renewing prescriptions, 98 (62%). African Americans (OR, 0.34; 95% CI, 0.16-0.72 vs White patients), patients with less formal education (OR, 0.06; 95% CI, 0.01-0.36), and those with lower income (OR, 0.28; 95% CI, 0.13-0.60; and OR, 0.26; 95% CI, 0.12-0.54 comparing income < $25,000 and $25,000-$50,000, respectively, with ≥$50,000) had lower odds of using the portal. In adjusted analysis, only lower income predicted lower portal use. Examining patient-centered outcomes in univariable analysis, portal users had higher knowledge (β = 4.89; P = 0.02), higher ratings of current health (β = 0.28; P = 0.03), and lower CKD-related stress (β = -0.18; P = 0.05). In adjusted analysis, only patient demographics and/or kidney function remained independent predictors of patient-centered outcomes.LimitationsCross-sectional study design, cannot determine causality.ConclusionsInterventions are needed to ensure that all patients have access to portals to mitigate disparities in care.
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Project description:Medicare patients and other stakeholders often make health care decisions that have economic consequences. Research on economic variables that patients have identified as important is referred to as patient-centered outcomes research (PCOR) and can generate evidence that informs decision-making. Medicare fee-for-service (FFS) claims are widely used for research and are a potentially valuable resource for studying some economic variables, particularly when linked to other datasets. The aim of this study was to identify and assess the characteristics of federally funded administrative and survey data sources that can be linked to Medicare claims for conducting PCOR on some economic outcomes. A targeted internet search was conducted to identify a list of relevant data sources. A technical panel and key informant interviews were used for guidance and feedback. We identified 12 survey and 6 administrative sources of linked data for Medicare FFS beneficiaries. A majority provide longitudinal data and are updated annually. All linked sources provide some data on social determinants of health and health equity-related factors. Fifteen sources capture direct medical costs (beyond Medicare FFS payments); 5 capture indirect costs (eg, lost wages from absenteeism), and 7 capture direct nonmedical costs (eg, transportation). Linking Medicare FFS claims data to other federally funded data sources can facilitate research on some economic outcomes for PCOR. However, few sources capture direct nonmedical or indirect costs. Expanding linkages to include additional data sources, and reducing barriers to existing data sources, remain important objectives for increasing high-quality, patient-centered economic research.
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Project description:ObjectivesAs part of a series of Patient-Centered Outcomes Research Institute-funded large-scale retrospective observational studies on bipolar disorder (BD) treatments and outcomes, we sought the input of patients with BD and their family members to develop research questions. We aimed to identify systemic root causes of patient-reported challenges with BD management in order to guide subsequent studies and initiatives.MethodsThree focus groups were conducted where patients and their family members (total n = 34) formulated questions around the central theme, "What do you wish you had known in advance or over the course of treatment for BD?" In an affinity mapping exercise, participants clustered their questions and ranked the resulting categories by importance. The research team and members of our patient partner advisory council further rated the questions by expected impact on patients. Using a Theory of Constraints systems thinking approach, several causal models of BD management challenges and their potential solution were developed with patients using the focus group data.ResultsA total of 369 research questions were mapped to 33 categories revealing 10 broad themes. The top priorities for patient stakeholders involved pharmacotherapy and treatment alternatives. Analysis of causal relationships underlying 47 patient concerns revealed two core conflicts: for patients, whether or not to take pharmacotherapy, and for mental health services, the dilemma of care quality vs quantity.ConclusionsTo alleviate the core conflicts identified, BD management requires a coordinated multidisciplinary approach including: improved access to mental health services, objective diagnostics, sufficient provider visit time, evidence-based individualized treatment, and psychosocial support.
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