Predictive Criterion Validity of the Parsley Symptom Index Against the Patient-Reported Outcomes Measurement Information System-10 in a Chronic Disease Cohort: Retrospective Cohort Study.

BACKGROUND: Approximately 60% of US adults live with chronic disease, imposing a significant burden on patients and the health care system. With the rise of telehealth, patient-reported outcomes measures (PROMs) have emerged as pivotal tools for managing chronic disease. While numerous PROMs exist, few have been designed explicitly for telehealth settings. The Parsley Symptom Index (PSI) is an electronic patient-reported outcome measure (ePROM) developed specifically for telehealth environments. OBJECTIVE: Our aim is to determine whether the PSI predicts changes in the established Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) Global Health, a 10-question short form. METHODS: We conducted a retrospective cohort study using data from 367 unique patients, amassing 1170 observations between August 30, 2017, and January 30, 2023. Patients completed the PSI and the PROMIS-10 multiple times throughout the study period. Using univariate regression models, we assess the predictive criterion validity of the PSI against PROMIS-10 scores. RESULTS: This study revealed significant relationships between the PSI and PROMIS-10 physical and mental health scores through comprehensive univariate analyses, thus establishing support for the criterion validity of the PSI. These analyses highlighted the PSI's potential as an insightful tool for understanding and predicting both mental and physical health dimensions. CONCLUSIONS: Our findings emphasize the importance of the PSI in capturing the nuanced interactions between symptomatology and health outcomes. These insights reinforce the value of the PSI in clinical contexts and support its potential as a versatile tool in both research and practice.

Parsley Health: Feasibility and acceptability of a large-scale holistic telehealth program for chronic disease care.

Background: A holistic, personalized approach to medicine can be used to prevent and manage a variety of chronic diseases. However, effectively managing chronic diseases can be difficult due to barriers related to insufficient provider time, staffing, and lack of patient engagement. To address these challenges telehealth strategies are being increasingly adopted, yet few studies have explored how to evaluate the feasibility and implementation success of large-scale holistic telehealth models for chronic disease care. The aim of this study is to assess the feasibility and acceptability of a large-scale holistic telehealth program for the management of chronic diseases. Our study findings can inform the future development and assessment of chronic disease programs delivered through telehealth strategies. Methods: Data was collected from participants enrolled in a Parsley Health membership from June 1, 2021 to June 1, 2022, a subscription-based holistic medicine practice designed to help people prevent or manage chronic diseases. Implementation outcome frameworks were used to understand engagement with services, participant satisfaction, and preliminary effectiveness of the program via a patient-reported symptom severity tool. Results: Data from 10,205 participants with a range of chronic diseases were included in our analysis. Participants averaged 4.8 visits with their clinical team and reported high levels of satisfaction with their care (average NPS score of 81.35%). Preliminary evidence also showed substantial reduction in patient reported symptom severity. Conclusion: Our findings suggest the Parsley Health program is a feasible and acceptable large-scale holistic telehealth program for chronic disease care. Successful implementation was due, in part, to services that promoted participant engagement along with tools and interfaces that were helpful and easy to use. These findings can be used to develop future holistic-focused telehealth programs for the management and prevention of chronic diseases.

Validity of the Parsley Symptom Index-an Electronic Patient-Reported Outcomes Measure Designed for Telehealth: Prospective Cohort Study.

BACKGROUND: Electronic patient-reported outcomes measures (e-PROMs) are a valuable tool for the monitoring and management of chronic conditions over time. However, there are few validated tools available that capture symptoms across body systems in telehealth settings. The Parsley Symptom Index (PSI) is a recently developed symptom assessment for adults with chronic disease in telehealth settings. A previous study demonstrated the feasibility and acceptability of the PSI in a clinical telehealth setting. OBJECTIVE: The purpose of this study was to assess convergent validity between the PSI and the self-rated health (SRH) item. METHODS: This prospective cohort study took place from January 15, 2021, to December 15, 2021, among a sample of 10,519 adult patients at Parsley Health, a subscription-based holistic medical practice. The PSI and the SRH were completed by patients via an online portal. The association between the PSI and SRH was assessed via polyserial and polychoric correlations, while weighted κ scores provided information related to agreement between the PSI and SRH. RESULTS: From 22,748 responses, there were moderate levels of association (polyserial r=0.51; polychoric r=0.52) and agreement (weighted κ=0.46) between the PSI and SRH. In total, 74.13% (n=16,865) of responses between the PSI and SRH were relatively congruent while 36.17% (n=8229) were literally congruent. CONCLUSIONS: The PSI demonstrates convergent validity with the SRH for adults with chronic disease in a telehealth setting. This finding further supports the validation of the PSI in a real-world clinical setting. Although it is conceptually similar to the 1-question SRH, the PSI is a 45-item PROM designed to capture quality of life and specific symptoms by body system. Future studies will compare the PSI to multi-item PROMs.

The Development of a Digital Patient-Reported Outcome Measurement for Adults With Chronic Disease (The Parsley Symptom Index): Prospective Cohort Study.

BACKGROUND: The monitoring and management of chronic illness has always been a challenge. Patient-reported outcome measures (PROMs) can be powerful tools for monitoring symptoms and guiding treatment of chronic diseases, but the available PROM tools are either too broad or too disease specific for the needs of a primary care practice focused on longitudinal care. OBJECTIVE: In this study we describe the development and preliminary validation of the Parsley Symptom Index (PSI). METHODS: This prospective cohort study took place from January 5, 2018, to June 05, 2020, among a sample of 4621 adult patients at Parsley Health. After a review of literature, followed by binning and winnowing of potential items, a 45-item PROM that also served as a review of systems (ROS) was developed. The PSI was deployed and completed by patients via an online portal. Construct and face validity was performed by clinicians, tested on patients, and feasibility was measured by response rate, completion rate, and percentage of missing data. RESULTS: The response rate for 12,175 collected PSIs was 93.72% (4331/4621) with a 100% item completion rate. A confirmatory factor analysis confirmed the model structure was satisfactory by a Comparative Fit Index of 0.943, Tucker-Lewis index of 0.938, and root mean square error of approximation of 0.028. CONCLUSIONS: A 45-item ROS-style PROM designed to capture chronic disease symptoms was developed, and preliminary validation suggests that the PSI can be deployed, completed, and helpful to both patients and clinicians.

Acceptability and Feasibility of a Mindfulness-Based Intervention for Pain Catastrophizing among Persons with Sickle Cell Disease.

BACKGROUND: Few investigators have developed and tested nonpharmacological interventions for helping persons with sickle cell disease (SCD) manage persistent pain. AIMS: The purpose of this pilot study was to examine the feasibility and acceptability of a mindfulness-based intervention (MBI) in adults with SCD and chronic pain and to gather preliminary data on its efficacy. DESIGN: Data on feasibility and acceptability, including recruitment, retention, and attendance rates, were collected during a single-site, randomized control trial. Participants were randomly assigned to either a 6-session group telephonic MBI or a wait-listed control. Pain catastrophizing was assessed at baseline and at weeks 1, 3, and 6. SETTING: Outpatient, comprehensive, interdisciplinary sickle cell disease center in the Southeast. PARTICIPANTS/SUBJECTS: Adults at least 18 years of age with a self-reported diagnosis of sickle cell disease who self-identified as having chronic, non-cancer pain that persisted on most days for at least 6 months and adversely affected function and/or well-being. METHODS: Seventy-eight adults were recruited; 18 (23%) declined to participate; 60 were randomly assigned to either the MBI (N = 40) or control (N = 20). Of those, 14 (35%) from the MBI and 12 (60%) from the control group withdrew immediately after random allocation, resulting in 34 evaluable cases (MBI: N = 26; control: N = 8). RESULTS: Among the 26 assigned to MBI, the median number of sessions attended per person was 4; 7 (27%) attended all six sessions. Qualitative findings indicated that MBI participants viewed the program as acceptable and liked the telephonic format, community, and content. Reductions in pain catastrophizing outcomes were identified after intervention. CONCLUSIONS: An MBI is feasible and acceptable for persons with SCD experiencing chronic pain. A larger randomized controlled trial to establish MBI efficacy on pain and related outcomes for SCD will provide nonpharmacologic, behavioral pain management options for nurses and other clinicians caring for persons with SCD and chronic pain.

Decreased Bleeding Incidence with Direct Oral Anticoagulants Compared to Vitamin K Antagonist and Low-Molecular-Weight Heparin in Patients with Sickle Cell Disease and Venous Thromboembolism.

BACKGROUND: Venous thromboembolism (VTE) is a recognized complication of sickle cell disease (SCD), yet the optimal pharmacologic anticoagulant is unknown. METHODS: A retrospective single-institution cohort study of patients with SCD complicated by first VTE from January 2009 through July 2017 was performed using ICD 9/10 codes. Data collected included the anticoagulant used, VTE recurrence, and incidence of bleeding. RESULTS: 109 patients with VTE were identified. SCD genotypes included HbSS in 92 (84%), HbSC in 13 (12%), and HbS-ß+ thalassemia in 4 (4%). After the initial VTE event, 32 patients received a vitamin K antagonist (VKA), 34 for low-molecular-weight heparin (LMWH), and 43 for direct oral anticoagulants (DOACs). 16 patients (15%) experienced a clinically significant bleeding event, including 9 on VKA, 5 on LMWH, and 2 on DOACs. At a median follow-up of 11.8 (range, 3.4-60) months, 33 patients had a recurrent VTE, including 10 on VKA, 10 on LMWH, and 13 on DOACs (p = 0.833). Bleeding incidence was least with the DOACs, which were associated with fewer bleeding events (OR 0.22), and greatest with VKA (OR 1.55) (p < 0.05). CONCLUSION: There was no difference between VTE recurrence and choice of anticoagulation in SCD patients with VTE. Bleeding events were lower for DOACs compared to VKA or LMWH.

Clinical Encounters and Treatment Initiation for Chronic Hepatitis C Patients: Applications of Adaptive Leadership Framework for Chronic Illness.

Chronic Hepatitis C (CHC) is the most common blood-borne infection in the U. S. Patients with CHC undergoing treatment face many challenges including adherence to medications and management of symptoms; health care practitioners are well positioned to facilitate patients' ability to address these challenges. We used the Adaptive Leadership for Chronic Illness Framework to investigate the difficulties inherent in affecting behavior change in patients undergoing treatment. We enrolled 11 patient participants and 10 provider participants. We used data from the first clinical encounter between patients and providers during which treatment was discussed. We found examples of adaptive leadership and categorized these behaviors into three themes: support for medication, coping with family/ home life, and strategizing to manage employment. We also saw examples of what we termed missed opportunities for adaptive leadership. This study illustrates the contributions of adaptive leadership behaviors by healthcare providers and the potential risk to patients in their absence.

Social and Behavioral Factors in Sickle Cell Disease: Employment Predicts Decreased Health Care Utilization.

THE PURPOSE: to determine frequency of health care encounters among people with sickle cell disease (SCD) seeking treatment for a vaso-occlusive crisis (VOC). Health care encounters are categorized by visit type (day hospital, ED visit, hospitalization), prevalence of self-reported behavioral and social factors, and any associations between behavioral and social factors and health care encounters. Ninety-five people with SCD were enrolled in a prospective descriptive study in North Carolina. Patients were interviewed concerning behavioral-social factors, and a report of health care encounters was produced, generated by ICD codes associated with VOCs between October 2011 and March 2014. Among 95 patients, there were a total of 839 day hospital and 1,990 ED visits, and 1,101 hospital admissions. Prevalent behavioral and social factors were depression (29%), anxiety (34%), illicit drug use (6%); unstable home situation (17%); and unemployment (81%). Employment and stable home were significantly associated with decreased frequency of health care encounters.

A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial.

BACKGROUND: One of the most difficult symptoms for persons with sickle cell disease (SCD) to manage is chronic pain. Chronic pain impacts approximately one-third of persons with SCD and is associated with increased pain intensity, pain behavior, and frequency and duration of hospital visits. A promising category of nonpharmacological interventions for managing both physical and affective components of pain are mindfulness-based interventions (MBIs). METHODS/DESIGN: The primary aim of this study is to conduct a randomized controlled study to evaluate the acceptability and feasibility, as well as to determine the preliminary efficacy, of a telephonic MBI for adults with SCD who have chronic pain. We will enroll 60 adult patients with SCD and chronic pain at an outpatient comprehensive SCD center in the southeastern United States. Patients will be randomized to either an MBI or a wait-listed control group. The MBI group will complete a six-session (60 minutes), telephonically delivered, group-based MBI program. The feasibility, acceptability, and efficacy of the MBI regarding pain catastrophizing will be assessed by administering questionnaires at baseline and weeks 1, 3, and 6. In addition, ten randomly selected MBI participants will complete semistructured interviews to help determine intervention acceptability. DISCUSSION: In this study protocol, we report detailed methods of the randomized controlled trial. Findings of this study will be useful to determine the acceptability, feasibility, and efficacy of an MBI for persons with SCD and chronic pain. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02394587 . Registered on 9 February 2015.

Sickle Cell Disease: A Review of Nonpharmacological Approaches for Pain.

CONTEXT: Sickle cell disease (SCD) is a life-threatening condition that affects more than seven million people worldwide. The most common complication experienced by persons living with SCD is pain. Evidence supports the use of nonpharmacologic therapies in managing psychological and social complications of pain in persons with SCD, but there is little consensus if these approaches can also be applied for the treatment of pain in SCD. OBJECTIVES: To describe and synthesize the use of nonpharmacological therapies for reducing pain of any type and origin in persons with SCD. METHODS: A literature search was conducted using PsycINFO, PsycARTICLES, PubMed, CINAHL, and Embase. Databases were searched using the following terms: sickle cell, pain, and nonpharmacological therapies. Interventions were graded for methodological quality and categorized as 1) peer-support group therapies, 2) educational/psychological therapies, and 3) skill-based therapies. RESULTS: Twenty-eight nonpharmacological interventions for persons with SCD were examined. Of these studies, a wide variety of nonpharmacological interventions were tested. Twelve studies yielded significant improvements in pain, three studies reported no positive effect or differences between experimental and control conditions on pain or a pain-related outcome, and one study reported a negative or detrimental intervention effect. CONCLUSION: Approximately half of the studies reviewed demonstrated success in alleviating pain, suggesting that patients are able to use nonpharmacological interventions to reduce pain with some degree of success. Questions still remain regarding the efficacy and generalizability of these interventions for persons with SCD.

Mindfulness-Based Stress Reduction in Advanced Nursing Practice: A Nonpharmacologic Approach to Health Promotion, Chronic Disease Management, and Symptom Control.

The aim of this article is to discuss how advanced practice nurses (APNs) can incorporate mindfulness-based stress reduction (MBSR) as a nonpharmacologic clinical tool in their practice. Over the last 30 years, patients and providers have increasingly used complementary and holistic therapies for the nonpharmacologic management of acute and chronic diseases. Mindfulness-based interventions, specifically MBSR, have been tested and applied within a variety of patient populations. There is strong evidence to support that the use of MBSR can improve a range of biological and psychological outcomes in a variety of medical illnesses, including acute and chronic pain, hypertension, and disease prevention. This article will review the many ways APNs can incorporate MBSR approaches for health promotion and disease/symptom management into their practice. We conclude with a discussion of how nurses can obtain training and certification in MBSR. Given the significant and growing literature supporting the use of MBSR in the prevention and treatment of chronic disease, increased attention on how APNs can incorporate MBSR into clinical practice is necessary.

Reappraisal facilitates extinction in healthy and socially anxious individuals.

BACKGROUND AND OBJECTIVES: Cognitive behavioral therapy (CBT) combines cognitive restructuring with exposure to feared stimuli in the treatment of anxiety disorders. Due to the complexities of cognition­emotion interactions during ongoing CBT, the underlying mechanisms remain unclear, which hinders treatment optimization. METHODS: We created a laboratory analogue by combining reappraisal, a key ingredient of cognitive restructuring, with Pavlovian conditioning, a key ingredient in behavioral treatments. The novel differential Pavlovian acquisition and extinction task featured social stimuli as conditioned and unconditioned stimuli under unregulated and reappraisal instructions. RESULTS: Findings indicated that reappraising the conditioned stimuli attenuated acquisition (Study 1) and facilitated extinction (Study 2) of conditioned negative valence. In Study 3, highly socially anxious individuals showed deficient extinction learning relative to low socially anxious individuals but compensated for this by using reappraisal. LIMITATIONS: Diagnostic status of participants was not assessed in structured clinical interviews. CONCLUSIONS: Reappraisal of feared stimuli could be useful in prevention and treatment of social anxiety.

See what you think: reappraisal modulates behavioral and neural responses to social stimuli.

The social environment requires people to quickly form contextually appropriate social evaluations. Models of social cognition suggest that this ability depends on the interaction of automatic and controlled evaluative systems. However, controlled processes, such as reappraisal of an initial response, have rarely been studied in the context of social evaluation. In the two studies reported here, participants reappraised or simply observed angry or neutral faces. In Study 1, reappraisal modulated evaluations of angry faces on explicit as well as implicit behavioral levels. In Study 2, reappraisal altered both early and late phases of evaluative electrocortical processing. These studies suggest that controlled processes, such as reappraisal, can quickly and substantially modulate early evaluative processes in the context of biologically significant social stimuli.