Patient Perceptions of Opioids and Benzodiazepines and Attitudes Toward Deprescribing.

BACKGROUND: Opioids and benzodiazepines (BZDs) pose a public health problem. Older adults are especially susceptible to adverse events from opioids and BZDs owing to an increased usage of opioids and BZDs, multiple comorbidities, and polypharmacy. Deprescribing is a possible, yet challenging, solution to reducing opioid and BZD use. OBJECTIVE: We aimed to explore older adult patients' knowledge of opioids and BZDs, perceived facilitators and barriers to deprescribing opioids and BZDs, and attitudes toward alternative treatments for opioids and BZDs. METHODS: We conducted 11 semi-structured interviews with patients aged 65+ years with long-term opioid and/or BZD prescriptions. The interview guide was developed by an interprofessional team and focused on patients' knowledge of opioids and BZDs, perceived ability to reduce opioid or BZD use, and attitudes towards alternative treatments. RESULTS: Three patients had taken opioids, either currently or in the past, three had taken BZDs, and five had taken both opioids and BZDs. Generally, knowledge of opioids and BZDs was variable among patients; yet facilitators and barriers to deprescribing both opioids and BZDs were consistent. Facilitators of deprescribing included patient-provider trust and slow tapering of medications, while barriers included concerns about re-emergence of symptoms and a lack of motivation, particularly if medications and symptoms were stable. Patients were generally unenthusiastic about pursuing alternative pharmacologic and non-pharmacologic alternatives to opioids and BZDs for symptom management. CONCLUSIONS: Our findings indicate that patients are open to deprescribing opioids and BZDs under certain circumstances, but overall remain hesitant with a lack of enthusiasm for alternative treatments. Future studies should focus on supportive approaches to alleviate older adults' deprescribing concerns.

Primary-Care Prescribers' Perspectives on Deprescribing Opioids and Benzodiazepines in Older Adults.

PURPOSE: Opioids and benzodiazepines (BZDs) are frequently implicated as contributing to falls in older adults. Deprescribing of these medications continues to be challenging. This study evaluated primary-care prescribers' confidence in and perceptions of deprescribing opioids and BZDs for older adults. METHODS: For this study, we conducted a quantitative analysis of survey data combined with an analysis of qualitative data from a focus group. A survey evaluating prescriber confidence in deprescribing opioids and BZDs was distributed to providers at 15 primary-care clinics in North Carolina between March-December 2020. Average confidence (scale 0-100) for deprescribing opioids, deprescribing BZDs, and deprescribing under impeding circumstances were reported. A virtual focus group was conducted in March 2020 to identify specific barriers and facilitators to deprescribing opioids and BZDs. Audio recordings and transcripts were analyzed using inductive coding. RESULTS: We evaluated 61 survey responses (69.3% response rate). Respondents were predominantly physicians (54.8%), but also included nurse practitioners (24.6%) and physician assistants (19.4%). Average overall confidence in deprescribing was comparable for opioids (64.5) and BZDs (65.9), but was lower for deprescribing under impeding circumstances (53.7). In the focus group, prescribers noted they met more resistance when deprescribing BZDs and that issues such as lack of time, availability of mental health resources, and patients seeing multiple prescribers were barriers to deprescribing. CONCLUSION: Findings from quantitative and qualitative analyses identified that prescribers were moderately confident in their ability to deprescribe both opioids and BZDs in older adults, but less confident under potentially impeding circumstances. Future studies are needed to evaluate policies and interventions to overcome barriers to deprescribing opioids and BZDs in primary care.

Qualitative measures that assess functional disability and quality of life in ALS.

BACKGROUND: Selection of appropriate trial endpoints and outcome measures is particularly important in rare disease and rapidly progressing disease such as amyotrophic lateral sclerosis (ALS) where the challenges to conducting clinical trials, are substantial: patient and disease heterogeneity, limited understanding of exact disease pathophysiology, and lack of robust and available biomarkers. To address these challenges in ALS, the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised version (ALSFRS-R) was developed and has become a key primary endpoint in ALS clinical trials to assess functional disability and disease progression, often replacing survival as a primary outcome. However, increased understanding of the ALS disease journey and improvements in assistive technology for ALS patients have exposed issues with the ALSFRS-R, including non-linearity, multidimensionality and floor and ceiling effects that could challenge its continued utility as a primary outcome measure in ALS clinical trials. Recently, other qualitative scale measures of functioning disability have been developed to help address these issues. With this in mind, we conducted a literature search aimed at identifying both established and promising new measures for potential use in clinical trials. METHODS: We searched PubMed, Google, Google Scholar, and the reference sections of key studies to identify papers that discussed qualitative measures of functional status for potential use in ALS studies. We also searched clinicaltrials.gov to identify functional status and health-related quality of life (HRQoL) measures that have been used in ALS interventional studies. RESULTS: In addition to the ALSFRS-R, we identified several newer qualitative scales including ALSFRS-EX, ALS-MITOS, CNS-BFS, DALS-15, MND-DS, and ROADS. Strengths and limitations of each measure were identified and discussed, along with their potential to act as a primary or secondary outcome to assess patient functional status in ALS clinical trials. CONCLUSION: This paper serves as a reference guide for researchers deciding which qualitative measures to use as endpoints in their ALS clinical trials to assess functional status. This paper also discusses the importance of including ALS HRQoL and ALS cognitive screens in future clinical trials to assess the value of a new ALS therapy more comprehensively.

Burden and Cost of Gastrointestinal, Liver, and Pancreatic Diseases in the United States: Update 2021.

BACKGROUND & AIMS: Gastrointestinal diseases account for considerable health care use and expenditures. We estimated the annual burden, costs, and research funding associated with gastrointestinal, liver, and pancreatic diseases in the United States. METHODS: We generated estimates using data from the National Ambulatory Medical Care Survey; National Hospital Ambulatory Medical Care Survey; Nationwide Emergency Department Sample; National Inpatient Sample; Kids' Inpatient Database; Nationwide Readmissions Database; Surveillance, Epidemiology, and End Results program; National Vital Statistics System; Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research; MarketScan Commercial Claims and Encounters data; MarketScan Medicare Supplemental data; United Network for Organ Sharing registry; Medical Expenditure Panel Survey; and National Institutes of Health (NIH). RESULTS: Gastrointestinal health care expenditures totaled $119.6 billion in 2018. Annually, there were more than 36.8 million ambulatory visits for gastrointestinal symptoms and 43.4 million ambulatory visits with a primary gastrointestinal diagnosis. Hospitalizations for a principal gastrointestinal diagnosis accounted for more than 3.8 million admissions, with 403,699 readmissions. A total of 22.2 million gastrointestinal endoscopies were performed, and 284,844 new gastrointestinal cancers were diagnosed. Gastrointestinal diseases and cancers caused 255,407 deaths. The NIH supported $3.1 billion (7.5% of the NIH budget) for gastrointestinal research in 2020. CONCLUSIONS: Gastrointestinal diseases are responsible for millions of health care encounters and hundreds of thousands of deaths that annually costs billions of dollars in the United States. To reduce the high burden of gastrointestinal diseases, focused clinical and public health efforts, supported by additional research funding, are warranted.

A Descriptive Review of Global Real World Evidence Efforts to Advance Drug Discovery and Clinical Development in Amyotrophic Lateral Sclerosis.

Understanding patient clinical progression is a key gateway to planning effective clinical trials and ultimately enabling bringing treatments to patients in need. In a rare disease like amyotrophic lateral sclerosis (ALS), studies of disease natural history critically depend on collaboration between clinical centers, regions, and countries to enable creation of platforms to allow patients, caregivers, clinicians, and researchers to come together and more fully understand the condition. Rare disease registries and collaborative platforms such as those developed in ALS collect real-world data (RWD) in standardized formats, including clinical and biological specimen data used to evaluate risk factors and natural history of disease, treatment patterns and clinical (ClinROs) and patient- reported outcomes (PROs) and validate novel endpoints. Importantly, these data support the development of new therapeutics by supporting the evaluation of feasibility and design of clinical trials and offer valuable information on real-world disease trajectory and outcomes outside of the clinical trial setting for comparative purposes. RWD may help to accelerate therapy development by identifying and validating outcome measures and disease subpopulations. RWD can also make potential contributions to the evaluation of the safety and effectiveness of new indications for approved products and to satisfy post-approval regulatory and market access requirements. There is a lack of amalgamated information on available registries, databases, and other sources of real-world data on ALS; thus, a global review of all available resources was warranted. This targeted review identifies and describes ALS registries, biobanks and collaborative research networks that are collecting and synthesizing RWD for the purposes of increasing patient awareness and advancing scientific knowledge with the hope of expediting future development of new therapies.

Transitioning Focus Group Research to a Videoconferencing Environment: A Descriptive Analysis of Interactivity.

The COVID-19 pandemic disrupted face-to-face interactions in healthcare research, with many studies shifting to video-based data collection for qualitative research. This study describes the interactivity achieved in a videoconferencing focus group of seven primary care providers discussing deprescribing opioids and benzodiazepines. Researchers reviewed video footage of a focus group conducted via Zoom and assessed interactivity using Morgan's framework for focus group communication processes. Two reviewers categorized the type of exchanges as sharing information, comparing experiences, organizing, and conceptualizing the content, as well as validating each other or galvanizing the discussion with "lightning strike" ideas. The conversation dynamics in this focus group included clear examples of interactivity in each of the categories proposed by Morgan (validating, sharing, comparing, organizing, conceptualizing, and lightning strikes) that were observed by two different reviewers with demonstrated high interrater reliability. Conducting focus groups with a skilled moderator using videoconferencing platforms with primary care providers is a viable option that produces sufficient levels of interaction.

Chronic Stress and Preconception Health Among Latina Women in Metro Atlanta.

BACKGROUND: Underserved subgroups are less likely to have optimal health prior to pregnancy. We describe preconception health indicators (behavior, pregnancy intention, and obesity) among pregnant Latina women with and without chronic stress in metro Atlanta. DESIGN: We surveyed 110 pregnant Latina women enrolled in prenatal care at three clinics in Atlanta. The survey assessed chronic stress, pregnancy intention, preconception behavior changes (taking folic acid or prenatal vitamins, seeking healthcare advice, any reduction in smoking or drinking), and previous trauma. RESULTS: Specific behaviors to improve health prior to pregnancy were uncommon (e.g., taking vitamins (25.5%) or improving nutrition (20.9%)). Just under half of women were experiencing a chronic stressor at the time of conception (49.5%). Chronically stressed women were more likely to be obese (aOR: 3.0 (1.2, 7.4)), less likely to intend their pregnancy (aOR: 0.3 (0.1, 0.7)), and possibly less likely to report any PHB (45.5% vs. 57.4%; aOR: 0.5 (0.2-1.1)). CONCLUSIONS: Chronically stress women were less likely to enter prenatal care with optimal health. However, preconception behaviors were uncommon overall.

Cancer Patients' Perspectives and Experiences of Chemotherapy-Induced Myelosuppression and Its Impact on Daily Life.

PURPOSE: To evaluate which side effects of chemotherapy are considered most burdensome by patients with cancer, identify which health care professionals pay most attention to symptoms associated with chemotherapy-induced myelosuppression (CIM) from the patient perspective, and capture the "patient voice" describing how CIM impacts their daily lives. PARTICIPANTS AND METHODS: Online survey of participants with breast, lung, or colorectal cancer who had received chemotherapy within the past 12 months and experienced ≥1 episode of CIM in the past year. Participants were asked to answer close-ended questions and provide qualitative responses to: "In your own words, please describe how side effects from myelosuppression have impacted your life." RESULTS: Among 301 survey participants, fatigue was the most frequently reported side effect of chemotherapy; 55% of participants rated fatigue as highly bothersome (9 or 10 on a 1-10 scale of "bothersomeness"). Participants rated symptoms associated with CIM, including fatigue, weakened immune system (infections), bleeding and/or bruising, and shortness of breath, as being as bothersome as other side effects of chemotherapy, including alopecia, neuropathy, and nausea/vomiting. Overall, 24-43% of participants thought that CIM and its symptoms had a negative impact on their daily lives, including their ability to complete tasks at home and work, and to socialize. Qualitative responses supported these findings; participants highlighted that CIM-related symptoms, particularly fatigue and fear of infections, affected their ability to be physically active, complete work, or continue meaningful relationships with friends and family. CONCLUSION: Participants described a real-world impact of CIM that often isolates them from family and friends, and means that they are unable to work or perform tasks of daily living. Using measures that help patients to recognize and communicate the signs and symptoms of CIM might increase the likelihood of maintaining daily lives as close to normal as possible, during and after chemotherapy treatment.

Patient Burden and Real-World Management of Chemotherapy-Induced Myelosuppression: Results from an Online Survey of Patients with Solid Tumors.

INTRODUCTION: Chemotherapy-induced myelosuppression (CIM) is one of the most common dose-limiting complications of cancer treatment, and is associated with a range of debilitating symptoms that can significantly impact patients' quality of life. The purpose of this study was to understand patients' perspectives on how the side effects of CIM are managed in routine clinical practice. METHODS: An online survey was conducted of participants with breast, lung, or colorectal cancer who had received chemotherapy treatment within the past 12 months, and had experienced at least one episode of myelosuppression in the past year. The survey was administered with predominantly close-ended questions, and lay definitions of key terms were provided to aid response selection. RESULTS: Of 301 participants who completed the online survey, 153 (51%) had breast cancer, 100 (33%) had lung cancer, and 48 (16%) had colorectal cancer. Anemia, neutropenia, lymphopenia, and thrombocytopenia were reported by 61%, 59%, 37%, and 34% of participants, respectively. Most participants (79%) reported having received treatment for CIM, and 64% of participants recalled chemotherapy dose modifications as a result of CIM. Although most participants believed their oncologist was aware of the side effects of CIM, and treated them quickly, 30% of participants felt their oncologists did not understand how uncomfortable they were due to the side effects of CIM. Overall, 88% of participants considered CIM to have a moderate or major impact on their lives. CONCLUSION: The data highlight that despite the various methods used to address CIM, and the patient-focused approach of oncologists, the real-world impact of CIM on patients is substantial. Improving communication between patients and health care providers may help improve patients' understanding of CIM, and foster shared decision-making in terms of treatment. Additional insights from patients should be obtained to further elucidate the totality of life burden associated with CIM.

This study looked at people with cancer who received chemotherapy and developed a condition where their bone marrow activity was reduced, called myelosuppression. This meant they had fewer red blood cells that carry oxygen around the body, white blood cells that help fight infections, and platelets that help the blood to clot. The researchers wanted to understand how chemotherapy-induced myelosuppression affects peoples' lives and their cancer treatment, and people's experiences of treatment for myelosuppression. Overall, 301 people in the USA with breast, lung, or large bowel (colorectal) cancer completed an online survey. They had all received chemotherapy in the last year, and had myelosuppression at least once during their treatment. The survey showed that around 8 in 10 people (79%) had to be treated for myelosuppression, and around 7 in 10 people (73%) felt they received treatment for myelosuppression quickly. Chemotherapy was delayed, reduced, or stopped because of myelosuppression in around 6 in 10 people (64%). Around 3 in 10 people (30%) felt their oncologist did not understand the discomfort that myelosuppression caused them, and around 9 in 10 people (88%) felt that myelosuppression made their quality of life worse. The researchers concluded that because myelosuppression impacts peoples' lives and their ability to keep receiving chemotherapy to treat their cancer, effective prevention and treatment for this condition are important. Better communication between people and their health care teams could help them to understand how people experience myelosuppression and make plans for treatment together.

Rationale and design of the Atrial Fibrillation health Literacy Information Technology Trial: (AF-LITT).

BACKGROUND: Atrial Fibrillation (AF) is a common cardiac arrhythmia that is challenging for patients and adversely impacts health-related quality of life (HRQoL). Long-term management of AF requires that patients adhere to complex therapies, understand difficult terminology, navigate subspecialty care, and have continued symptom monitoring with the goal of preventing adverse outcomes. Continued interventions to ameliorate the patient experience of AF are essential. DESIGN: The Atrial Fibrillation health Literacy Information Technology Trial (AF-LITT; NCT03093558) is an investigator-initiated, 2-arm randomized clinical trial (RCT). This RCT is a pilot in order to implement a novel, smartphone-based intervention to address the patient experience of AF. This pilot RCT will compare a combination of the Embodied Conversational Agent (ECA) and the Alive Cor Kardia Mobile heart rhythm monitor to the current standard of care. The study will enroll 180 adults with non-valvular AF who are receiving anticoagulation for stroke prevention and randomize them to receive a 30-day intervention (smartphone-based ECA/Kardia) or standard of care, which will include a symptom and adherence journal. The primary end-points are improvement in HRQoL and self-reported adherence to anticoagulation. The secondary end-points are the acceptability of the intervention to participants, its use by participants, and acceptability to referring physicians. CONCLUSIONS: The AF-LITT pilot aims to evaluate the efficacy of the ECA/Kardia to improve HRQoL and anticoagulant adherence, and to guide its implementation in a larger, multicenter clinical trial. The intervention has potential to improve HRQoL, adherence, and health care utilization in individuals with chronic AF.

The Atrial Fibrillation Health Literacy Information Technology System: Pilot Assessment.

BACKGROUND: Atrial fibrillation (AF) is a highly prevalent heart rhythm condition that has significant associated morbidity and requires chronic treatment. Mobile health (mHealth) technologies have the potential to enhance multiple aspects of AF care, including education, monitoring of symptoms, and encouraging and tracking medication adherence. We have previously implemented and tested relational agents to improve outcomes in chronic disease and sought to develop a smartphone-based relational agent for improving patient-centered outcomes in AF. OBJECTIVE: The objective of this study was to pilot a smartphone-based relational agent as preparation for a randomized clinical trial, the Atrial Fibrillation Health Literacy Information Technology Trial (AF-LITT). METHODS: We developed the relational agent for use by a smartphone consistent with our prior approaches. We programmed the relational agent as a computer-animated agent to simulate a face-to-face conversation and to serve as a health counselor or coach specific to AF. Relational agent's dialogue content, informed by a review of literature, focused on patient-centered domains and qualitative interviews with patients with AF, encompassed AF education, common symptoms, adherence challenges, and patient activation. We established that the content was accessible to individuals with limited health or computer literacy. Relational agent content coordinated with use of the smartphone AliveCor Kardia heart rate and rhythm monitor. Participants (N=31) were recruited as a convenience cohort from ambulatory clinical sites and instructed to use the relational agent and Kardia for 30 days. We collected demographic, social, and clinical characteristics and conducted baseline and 30-day assessments of health-related quality of life (HRQoL) with the Atrial Fibrillation Effect on Quality of life (AFEQT) measure; self-reported medication adherence with the Morisky 8-item Medication Adherence Scale (MMAS-8); and patient activation with the Patient Activation Measure (PAM). RESULTS: Participants (mean age 68 [SD 11]; 39% [12/31] women) used the relational agent for an average 17.8 (SD 10.0) days. The mean number of independent log-ins was 19.6 (SD 10.7), with a median of 20 times over 30 days. The mean number of Kardia uses was 26.5 (SD 5.9), and participants using Kardia were in AF for 14.3 (SD 11.0) days. AFEQT scores improved significantly from 64.5 (SD 22.9) at baseline to 76.3 (SD 19.4) units at 30 days (P<.01). We observed marginal but statistically significant improvement in self-reported medication adherence (baseline: 7.3 [SD 0.9], 30 days: 7.7 [SD 0.5]; P=.01). Assessments of acceptability identified that most of the participants found the relational agent useful, informative, and trustworthy. CONCLUSIONS: We piloted a 30-day smartphone-based intervention that combined a relational agent with dedicated content for AF alongside Kardia heart rate and rhythm monitoring. Pilot participants had favorable improvements in HRQoL and self-reported medication adherence, as well as positive responses to the intervention. These data will guide a larger, enhanced randomized trial implementing the smartphone relational agent and the Kardia monitor system.