The association between home mindfulness practice quantity in standard length mindfulness-based interventions (MBIs) and chronic pain outcomes is variable. Few studies focus on abbreviated MBIs (< ...8 weeks) and distinguish between formal guided practices and informal practices in daily life.
To characterize home mindfulness practice and explore associations between home practice quantity and pre-to-post-outcome changes after an MBI for chronic pain.
In this single-arm study, 21 adults with chronic pain (mean age = 54 years, 81% White, mean pain duration = 7 years) completed an MBI with four weekly group sessions. Pre and post self-report measures of pain intensity/interference, physical function, depression, anxiety, positive affect, sleep disturbance (all PROMIS measures), and pain acceptance, catastrophizing, perceived stress and mindfulness were completed, along with daily surveys of formal (mindfulness of breath, body scan) and informal (breathing space, mindfulness of daily activities) practice. Bivariate correlations and multivariable regression models were used to assess the association between days and minutes of practice and change in outcomes.
On average, formal practice was completed on 4.3 days per week and 13.5 minutes per day. Informal practice was completed on 3.5 days per week and 8.6 minutes per day. Formal practice was not significantly correlated with outcomes (Spearman's ρ = |.01|-|.32|), whereas informal practice was correlated with multiple outcomes (ρ = |.04|-|.66|). Number of days practiced informally was associated with improved pain interference, physical function, sleep disturbance, and catastrophizing (
's ≤ .05). Number of minutes practiced informally was associated with improved pain interference, anxiety, positive affect, and catastrophizing (
's ≤ .05).
Informal home practice quantity, but not formal practice quantity, is associated with improved outcomes during an abbreviated MBI for chronic pain. For these MBIs, it is important to evaluate the distinct roles of formal and informal practice.
NCT03495856.
Migraine is a prevalent neurological disorder, affecting over 16% of adult women and 7% of adult men in the U.S., causing significant pain, disability, and medical expense, with incomplete benefits ...from conventional medical management. Migraine, as a chronic pain syndrome, provides a practical model for investigating the impact of dietary modifications in omega-3 (n-3) and omega-6 (n-6) fatty acids. This paper reports the protocol of a trial to assess whether targeted dietary modifications designed to increase n-3 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), with or without concurrent reduction in n-6 linoleic acid (LA), will alter nociceptive lipid mediators and mediate decreases in frequency and severity of migraine. This prospective, randomized, controlled trial in 153 male and female adult subjects, ages 18–99, with diagnosed and actively managed episodic migraine tests the efficacy, safety, and biochemical effects of targeted, controlled alterations in dietary omega-3 and omega-6 fatty acids. Participants are masked to diet hypotheses and all assessors are masked to treatment assignment. Following a four-week baseline period, participants with migraine headache frequency of 5–20 per month are randomized to one of three intensive dietary regimens for 16 additional weeks followed by a less intensive observation period. Dietary intervention arms include: 1) increased n-3 EPA+DHA with low n-6 linoleic acid (H3 L6); 2) increased n-3 EPA+DHA with usual US dietary intake of n-6 linoleic acid (H3 H6); and 3) usual US dietary content of n-3 and n-6 fatty acids (L3 H6). During the actual intervention, subjects receive content-specific study oils and foods sufficient for two meals and two snacks per day, as well as dietary counseling. Biochemical and clinical outcome measures are performed at intervals throughout this period. This randomized controlled trial is designed to determine whether targeted alterations in dietary n-3 and n-6 fatty acids can alter nociceptive lipid mediators in a manner that decreases headache pain and enhances quality of life and function in adults with frequent migraines.
NCT02012790
•Lipid mediators derived from n-3 and n-6 fatty acids are proposed to regulate pain.•Targeted changes in fatty acids reduced headaches in a prior, small randomized trial.•The protocol for an ongoing larger, more tightly controlled trial is presented.
The NIH Pragmatic Trials Collaboratory supports the design and conduct of 27 embedded pragmatic clinical trials, and many of the studies collect patient reported outcome measures as primary or ...secondary outcomes. Study teams have encountered challenges in the collection of these measures, including challenges related to competing health care system priorities, clinician's buy-in for adoption of patient-reported outcome measures, low adoption and reach of technology in low resource settings, and lack of consensus and standardization of patient-reported outcome measure selection and administration in the electronic health record. In this article, we share case examples and lessons learned, and suggest that, when using patient-reported outcome measures for embedded pragmatic clinical trials, investigators must make important decisions about whether to use data collected from the participating health system's electronic health record, integrate externally collected patient-reported outcome data into the electronic health record, or collect these data in separate systems for their studies.
Embedded pragmatic clinical trials (ePCTs) are conducted during routine clinical care and have the potential to increase knowledge about the effectiveness of interventions under real world ...conditions. However, many pragmatic trials rely on data from the electronic health record (EHR) data, which are subject to bias from incomplete data, poor data quality, lack of representation from people who are medically underserved, and implicit bias in EHR design. This commentary examines how the use of EHR data might exacerbate bias and potentially increase health inequities. We offer recommendations for how to increase generalizability of ePCT results and begin to mitigate bias to promote health equity.
Post-traumatic headache (PTH) is common after traumatic brain injury (TBI), especially among active-duty service members (SMs), affecting up to 35% of patients with chronic TBI. Persistent PTH is ...disabling and frequently unresponsive to treatment and is often migrainous. Here, we describe a trial assessing whether dietary modifications to increase n-3 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) and reduce n-6 linoleic acid (LA), will alter nociceptive lipid mediators and result in clinical improvements in persistent PTH.
This prospective, randomized, controlled trial tests the efficacy, safety, and biochemical effects of targeted, controlled alterations in dietary n-3 and n-6 fatty acids in 122 adult SMs and military healthcare beneficiaries with diagnosed TBI associated with actively managed persistent frequent (>8 /month) PTH with migraine. Following a 4-week baseline, participants are randomized to one of two equally intensive dietary regimens for 12 additional weeks: 1) increased n-3 EPA + DHA with low n-6 LA (H3L6); 2) usual US dietary content of n-3 and n-6 fatty acids (Control). During the intervention, participants receive diet arm-specific study oils and foods sufficient for 75% of caloric needs and comprehensive dietary counseling. Participants complete daily headache diaries throughout the intervention. Clinical outcomes, including the Headache Impact Test (HIT-6), headache hours per day, circulating blood fatty acid levels, and bioactive metabolites, are measured pre-randomization and at 6 and 12 weeks. Planned primary analyses include pre-post comparisons of treatment groups on clinical measures using ANCOVA and mixed-effects models. Similar approaches to explore biochemical and exploratory clinical outcomes are planned.
ClinicalTrials.gov registration: NCT03272399
Purpose
Mind-body therapies (MBTs), a subset of complementary and alternative medicine (CAM), are used by cancer survivors to manage symptoms related to their cancer experience. MBT use may differ by ...cancer survivorship stage (i.e., acute, short-term, long-term) because each stage presents varying intensities of medical activities, associated emotions, and treatment effects. We examined the relationship between MBT use and survivorship stage (acute <1 year; short-term 1 to 5 years; long-term >5 years since diagnosis) using the CAM supplement of the 2012 National Health Interview Survey. We also examined reported reasons for and outcomes of MBT use and frequency of MBT types.
Methods
The sample included cancer survivors (
N
= 3076) and non-cancer controls (
N
= 31,387). Logistic regression tested the relationship of MBT use and survivorship stage. Weighted percentages were calculated by survivorship stage for reported reasons and outcomes of use and frequency of MBT types.
Results
MBT use varied by cancer survivorship stage (
p
= 0.02): acute (8.3 %), short-term (15.4 %), long-term (11.7 %) survivorship and non-cancer controls (13.2 %). In the adjusted model, short-term survivors had 35 % greater odds of MBT use than did controls (95 % CI 1.00, 1.83). Reasons for and outcomes of MBT use varied among the survivorship stages, with more acute survivors reporting medical-related reasons and more short-term survivors reporting to manage symptoms.
Conclusions
MBT may fulfill different symptom management needs at varying stages of survivorship. These findings can help inform supportive care services of survivors’ use of MBT for symptom burden at each stage and the allocation of these services.
Phantom limb pain (PLP) is a significant source of chronic pain in most persons with amputation at some time in their clinical course. Pharmacologic therapies for this condition are often only ...moderately effective and may produce unwanted adverse effects. There is growing empirical evidence of the therapeutic effectiveness of mind-body therapies for the relief of chronic pain; therefore, an exploration of their role in relieving amputation-related chronic pain is warranted. We undertook a focused literature review on mind-body interventions for patients with amputation who experience PLP. Because of study heterogeneity, only descriptive presentations of the studies are presented. Only studies of hypnosis, imagery, and biofeedback, including visual mirror feedback, were found; studies on meditation, yoga, and tai chi/qigong were missing from the literature. Few studies of specific mind-body therapies were dedicated to management of PLP, with the exception of mirror visual therapy. Overall, studies were largely exploratory and reflect considerable variability in the application of mind-body techniques, making definitive conclusions inadvisable. Nevertheless, the weight of existing findings indicates that a mind-body approach to PLP pain management is promising and that specific methods may offer either temporary or long-term relief, either alone or in combination with conventional therapies. The authors discuss the potential for usefulness of specific mind-body therapies and the relevance of their mechanisms of action to those of PLP, including targeting cortical reorganization, autonomic nervous system deregulation, stress management, coping ability, and quality-of-life. The authors recommend more and better quality research exploring the efficacy and mechanisms of action.
Targeted analgesic dietary interventions are a promising strategy for alleviating pain and improving quality of life in patients with persistent pain syndromes, such as chronic daily headache (CDH). ...High intakes of the omega-6 (n-6) polyunsaturated fatty acids (PUFAs), linoleic acid (LA) and arachidonic acid (AA) may promote physical pain by increasing the abundance, and subsequent metabolism, of LA and AA in immune and nervous system tissues. Here we describe methodology for an ongoing randomized clinical trial comparing the metabolic and clinical effects of a low n-6, average n-3 PUFA diet, to the effects of a low n-6 plus high n-3 PUFA diet, in patients with CDH. Our primary aim is to determine if: A) both diets reduce n-6 PUFAs in plasma and erythrocyte lipid pools, compared to baseline; and B) the low n-6 plus high n-3 diet produces a greater decline in n-6 PUFAs, compared to the low n-6 diet alone. Secondary clinical outcomes include headache-specific quality-of-life, and headache frequency and intensity.
Adults meeting the International Classification of Headache Disorders criteria for CDH are included. After a 6-week baseline phase, participants are randomized to a low n-6 diet, or a low n-6 plus high n-3 diet, for 12 weeks. Foods meeting nutrient intake targets are provided for 2 meals and 2 snacks per day. A research dietitian provides intensive dietary counseling at 2-week intervals. Web-based intervention materials complement dietitian advice. Blood and clinical outcome data are collected every 4 weeks.
Subject recruitment and retention has been excellent; 35 of 40 randomized participants completed the 12-week intervention. Preliminary blinded analysis of composite data from the first 20 participants found significant reductions in erythrocyte n-6 LA, AA and %n-6 in HUFA, and increases in n-3 EPA, DHA and the omega-3 index, indicating adherence.
ClinicalTrials.gov (NCT01157208).
Abstract Background Frailty is a dynamic aging-related syndrome, but measuring frailty transitions is challenging. The Faurot frailty index is a validated Medicare claims-based frailty proxy based on ...demographic and billing information. We evaluated whether three-year changes in the Faurot frailty index were consistent with concurrent changes in the frailty phenotype in a cohort of older adults. Methods We used longitudinal data from the National Health and Aging Trends (NHATS) study with Medicare claims linkage (2010-2018). We identified older adults (66+ years) in the 2011 and 2015 NHATS cohorts with at least one year of Medicare fee-for-service continuous enrollment (N=6,951). We described annual changes in mean claims-based frailty for up to three-years, based on concurrent transitions in the frailty phenotype. Results At baseline, 32% were robust, 48% prefrail, and 19% frail based on the frailty phenotype. Mean claims-based frailty for older adults who were robust at baseline and worsened to frail increased over three-years (0.09-0.25). Similarly, those who worsened from prefrail to frail experienced an increase in mean claims-based frailty (0.14-0.26). Improvements in the frailty phenotype did not correspond to decreases in claims-based frailty. Older adults whose frailty phenotype improved over time had a lower baseline claims-based frailty score than those who experienced stable or worsening frailty. Conclusions Older adults who experienced a frailty phenotype worsening over three years experienced concurrent increases in the Faurot frailty index. Our results suggest that claims data may be used to identify clinically meaningful worsening in frailty.
BACKGROUND
Use of dietary supplements (DS) is common in the United States; however little is known about the use of DS specifically in hospitalized patients.
OBJECTIVE
The goal of this study is to ...begin to characterize trends in DS use by hospitalized patients and to assess the degree of patient–physician communication about use of DS that occurs during hospitalization.
DESIGN
This is a cross-sectional, observational pilot study.
PARTICIPANTS
Participants were admitted to the general internal medicine or geriatrics service by house staff residents; those ≥ 18 years of age who were medically stable, cognitively intact and fluent in English and/or Spanish were invited to participate in the study.
RESULTS
Nearly 80% of hospitalized patients reported use of DS, with 52% reporting use of non-vitamin/non-mineral DS. During the admission process, physicians documented inquiring about DS use only 20% of the time. While the majority of patients had no concern about temporarily discontinuing their DS during hospitalization, 13% of patients reported that they believed there was nothing wrong with continued use of DS while hospitalized regardless of the recommendations provided by their inpatient physicians.
CONCLUSIONS
Use of DS in hospitalized patients is common, and communication between patients and physicians regarding their use is limited.
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