Person: Davis, Roger
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Davis, Roger
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Publication Tai chi mind-body exercise in patients with COPD: study protocol for a randomized controlled trial(BioMed Central, 2014) Yeh, Gloria; Wayne, Peter; Litrownik, Daniel; Roberts, David; Davis, Roger; Moy, Marilyn LBackground: Chronic obstructive pulmonary disease (COPD) is a chronic, progressively debilitating condition that is prevalent in the US and worldwide. Patients suffer from progressive dyspnea and exercise intolerance. Physical exercise is beneficial, but conventional pulmonary rehabilitation programs are underutilized. There remains a need for novel interventions that improve symptoms, quality-of-life, and functional capacity. Tai chi is an increasingly popular mind-body exercise that includes physical exercise, breathing training, mindful awareness, and stress management--components that are essential to the self-management of COPD. There are, however, limited data on the effectiveness of tai chi as a therapeutic intervention in this population. Methods/Design The Primary Aims are to evaluate the efficacy, safety, and feasibility of a 12-week tai chi program for patients with COPD. We utilize a randomized controlled trial design, with participants assigned in a 2:1 ratio to either a group tai chi program (N = 63) or a time/attention-matched education control (N = 31). Our primary outcomes are COPD-specific quality-of-life and exercise capacity. Secondary outcomes include dyspnea, mood, functional status, self-efficacy, and lung function. Cardiopulmonary exercise testing is done in a subset of patients (N = 50). To explore optimal training duration, a subgroup of patients in tai chi are randomly assigned to complete an additional 12 weeks training (total 24 weeks) (Exploratory Aim 1). To explore the impact of a simplified seated intervention including only a subset of tai chi’s training components, a third randomly assigned group (N = 31) receives a 12- week mind-body breathing program (N = 31) (Exploratory Aim 2). Discussion Results of the BEAM study (Breathing, Education, Awareness, Movement) will provide preliminary evidence regarding the value of tai chi for improving quality of life and exercise capacity in patients with COPD, including information regarding optimal duration. They will also inform the feasibility and potential benefit of an alternative mind-body breathing intervention, and provide insight regarding how isolated mind-body exercise components contribute to the overall effects of tai chi. Should the results be positive, tai chi and related mind-body practices may offer a novel exercise option that is potentially accessible to a large proportion of patients with COPD. Trial registration This trial is registered in Clinical Trials.gov, ID number NCT01551953. Date of Registration March 1 2012. Electronic supplementary material The online version of this article (doi:10.1186/1745-6215-15-337) contains supplementary material, which is available to authorized users.Publication Complexity-Based Measures Inform Effects of Tai Chi Training on Standing Postural Control: Cross-Sectional and Randomized Trial Studies(Public Library of Science, 2014) Wayne, Peter; Gow, Brian J.; Costa, Madalena; Peng, C.-K.; Lipsitz, Lewis; Hausdorff, Jeffrey M.; Davis, Roger; Walsh, Jacquelyn N.; Lough, Matthew; Novak, Vera; Yeh, Gloria; Ahn, Andrew; Macklin, Eric; Manor, BradBackground: Diminished control of standing balance, traditionally indicated by greater postural sway magnitude and speed, is associated with falls in older adults. Tai Chi (TC) is a multisystem intervention that reduces fall risk, yet its impact on sway measures vary considerably. We hypothesized that TC improves the integrated function of multiple control systems influencing balance, quantifiable by the multi-scale “complexity” of postural sway fluctuations. Objectives: To evaluate both traditional and complexity-based measures of sway to characterize the short- and potential long-term effects of TC training on postural control and the relationships between sway measures and physical function in healthy older adults. Methods: A cross-sectional comparison of standing postural sway in healthy TC-naïve and TC-expert (24.5±12 yrs experience) adults. TC-naïve participants then completed a 6-month, two-arm, wait-list randomized clinical trial of TC training. Postural sway was assessed before and after the training during standing on a force-plate with eyes-open (EO) and eyes-closed (EC). Anterior-posterior (AP) and medio-lateral (ML) sway speed, magnitude, and complexity (quantified by multiscale entropy) were calculated. Single-legged standing time and Timed-Up–and-Go tests characterized physical function. Results: At baseline, compared to TC-naïve adults (n = 60, age 64.5±7.5 yrs), TC-experts (n = 27, age 62.8±7.5 yrs) exhibited greater complexity of sway in the AP EC (P = 0.023), ML EO (P<0.001), and ML EC (P<0.001) conditions. Traditional measures of sway speed and magnitude were not significantly lower among TC-experts. Intention-to-treat analyses indicated no significant effects of short-term TC training; however, increases in AP EC and ML EC complexity amongst those randomized to TC were positively correlated with practice hours (P = 0.044, P = 0.018). Long- and short-term TC training were positively associated with physical function. Conclusion: Multiscale entropy offers a complementary approach to traditional COP measures for characterizing sway during quiet standing, and may be more sensitive to the effects of TC in healthy adults. Trial Registration ClinicalTrials.gov NCT01340365Publication Neuropsychiatric Symptoms and Expenditure on Complementary and Alternative Medicine(Physicians Postgraduate Press, Inc, 2015) Purohit, Maulik Prafull; Zafonte, Ross; Sherman, Laura M.; Davis, Roger; Giwerc, Michelle Y.; Shenton, Martha; Yeh, GloriaObjective—Neuropsychiatric symptoms affect 37% of US adults. These symptoms are often refractory to standard therapies, and patients may consequently opt for complementary and alternative medicine therapies (CAM). We sought to determine the demand for CAM by those with neuropsychiatric symptoms compared to those without neuropsychiatric symptoms as measured by out-of-pocket expenditure. Method—We compared CAM expenditure between US adults with and without neuropsychiatric symptoms (n = 23,393) using the 2007 National Health Interview Survey. Symptoms included depression, anxiety, insomnia, attention deficits, headaches, excessive sleepiness, and memory loss. CAM was defined per guidelines from the National Institutes of Health as mind body therapies, biological therapies, manipulation therapies, or alternative medical systems. Expenditure on CAM by those without neuropsychiatric symptoms was compared to those with neuropsychiatric symptoms. Results—Of the adults surveyed, 37% had ≥ 1 neuropsychiatric symptom and spent $ 14.8 billion out-of-pocket on CAM. Those with ≥ 1 neuropsychiatric symptom were more likely than those without neuropsychiatric symptoms to spend on CAM (27.4% vs 20.3%, P < .001). Likelihood to spend on CAM increased with number of symptoms (27.2% with ≥ 3 symptoms, P < .001). After adjustment was made for confounders using logistic regression, those with ≥ 1Publication Effectiveness of Visual Inspection Compared With Non-Microbiologic Methods to Determine the Thoroughness of Post-Discharge Cleaning(Springer Nature, 2013) Snyder, Graham Michael; Holyoak, Aleah D; Leary, Katharine E; Sullivan, Bernadette F; Davis, Roger; Wright, SharonBackground: Published data to date have provided a limited comparison between non-microbiologic methods—particularly visual inspection—and a microbiologic comparator to evaluate the effectiveness of environmental cleaning of patient rooms. We sought to compare the accuracy of visual inspection with other non-microbiologic methods of assessing the effectiveness of post-discharge cleaning (PDC). Methods: Prospective evaluation to determine the effectiveness of PDC in comparison to a microbiologic comparator. Using a highly standardized methodology examining 15 high-touch surfaces, the effectiveness of PDC was evaluated by visual inspection, the removal of fluorescent marker (FM) placed prior to room occupancy, quantification of adenosine triphosphate (ATP) levels, and culture for aerobic colony counts (ACC). Results: Twenty rooms including 293 surfaces were sampled in the study, including 290 surfaces sampled by all four methods. ACC demonstrated 72% of surfaces to be microbiologically clean. Visual inspection, FM, ATP demonstrated 57%, 49%, and 66% of surfaces to be clean. Using ACC as a microbiologic comparator, the sensitivity of visual inspection, FM, and ATP to detect a clean surface were 60%, 51%, and 70%, respectively; the specificity of visual inspection, FM, and ATP were 52%, 56%, and 44%. Conclusions: In assessing the effectiveness of PDC, there was poor correlation between the two most frequently studied commercial methods and a microbiologic comparator. Visual inspection performed at least as well as commercial methods, directly addresses patient perception of cleanliness, and is economical to implement.Publication Structural Integration as an Adjunct to Outpatient Rehabilitation for Chronic Nonspecific Low Back Pain: A Randomized Pilot Clinical Trial(Hindawi Publishing Corporation, 2015) Jacobson, Eric; Meleger, Alec; Bonato, Paolo; Wayne, Peter; Langevin, Helene; Kaptchuk, Ted; Davis, RogerStructural Integration (SI) is an alternative method of manipulation and movement education. To obtain preliminary data on feasibility, effectiveness, and adverse events (AE), 46 outpatients from Boston area with chronic nonspecific low back pain (CNSLBP) were randomized to parallel treatment groups of SI plus outpatient rehabilitation (OR) versus OR alone. Feasibility data were acceptable except for low compliance with OR and lengthy recruitment time. Intent-to-treat data on effectiveness were analyzed by Wilcoxon rank sum, n = 23 per group. Median reductions in VAS Pain, the primary outcome, of −26 mm in SI + OR versus 0 in OR alone were not significantly different (P = 0.075). Median reductions in RMDQ, the secondary outcome, of −2 points in SI + OR versus 0 in OR alone were significantly different (P = 0.007). Neither the proportions of participants with nor the seriousness of AE were significantly different. SI as an adjunct to OR for CNSLBP is not likely to provide additional reductions in pain but is likely to augment short term improvements in disability with a low additional burden of AE. A more definitive trial is feasible, but OR compliance and recruitment might be challenging. This trial is registered with ClinicalTrials.gov (NCT01322399).Publication Conscientiousness is modified by genetic variation in catechol-O-methyltransferase to reduce symptom complaints in IBS patients(BlackWell Publishing Ltd, 2014) Hall, Kathryn; Tolkin, Benjamin R; Chinn, Garrett M; Kirsch, Irving; Kelley, John; Lembo, Anthony; Kaptchuk, Ted; Kokkotou, Efi; Davis, Roger; Conboy, LisaBackground: Attention to and perception of physical sensations and somatic states can significantly influence reporting of complaints and symptoms in the context of clinical care and randomized trials. Although anxiety and high neuroticism are known to increase the frequency and severity of complaints, it is not known if other personality dimensions or genes associated with cognitive function or sympathetic tone can influence complaints. Genetic variation in catechol-O-methyltransferase (COMT) is associated with anxiety, personality, pain, and response to placebo treatment. We hypothesized that the association of complaint reporting with personality might be modified by variation in the COMT val158met genotype. Methods: We administered a standard 25-item complaint survey weekly over 3-weeks to a convenience sample of 187 irritable bowel syndrome patients enrolled in a placebo intervention trial and conducted a repeated measures analysis. Results: We found that complaint severity rating, our primary outcome, was negatively associated with the personality measures of conscientiousness (β = −0.31 SE 0.11, P = 0.003) and agreeableness (β = −0.38 SE 0.12, P = 0.002) and was positively associated with neuroticism (β = 0.24 SE 0.09, P = 0.005) and anxiety (β = 0.48 SE 0.09, P < 0.0001). We also found a significant interaction effect of COMT met alleles (β = −32.5 SE 14.1, P = 0.021). in patients genotyped for COMT val158met (N = 87) specifically COMT × conscientiousness (β = 0.73 SE 0.26, P = 0.0042) and COMT × anxiety (β = −0.42 SE 0.16, P = 0.0078) interaction effects. Conclusion: These findings potentially broaden our understanding of the factors underlying clinical complaints to include the personality dimension of conscientiousness and its modification by COMT.Publication Open-label versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial(BioMed Central, 2017) Ballou, Sarah; Kaptchuk, Ted; Hirsch, William; Nee, Judy; Iturrino, Johanna; Hall, Kathryn; Kelley, John; Cheng, Vivian; Kirsch, Irving; Jacobson, Eric; Conboy, Lisa; Lembo, Anthony; Davis, RogerBackground: Placebo medications, by definition, are composed of inactive ingredients that have no physiological effect on symptoms. Nonetheless, administration of placebo in randomized controlled trials (RCTs) and in clinical settings has been demonstrated to have significant impact on many physical and psychological complaints. Until recently, conventional wisdom has suggested that patients must believe that placebo pills actually contain (or, at least, might possibly contain) active medication in order to elicit a response to placebo. However, several recent RCTs, including patients with irritable bowel syndrome (IBS), chronic low back pain, and episodic migraine, have demonstrated that individuals receiving open-label placebo (OLP) can still experience symptomatic improvement and benefit from honestly described placebo treatment. Methods and design This paper describes an innovative multidisciplinary trial design (n = 280) that attempts to replicate and expand upon an earlier IBS OLP study. The current study will compare OLP to double-blind placebo (DBP) administration which is made possible by including a nested, double-blind RCT comparing DBP and peppermint oil. The study also examines possible genetic and psychological predictors of OLP and seeks to better understand participants’ experiences with OLP and DBP through a series of extensive interviews with a randomly selected subgroup. Discussion OLP treatment is a novel strategy for ethically harnessing placebo effects. It has potential to re-frame theories of placebo and to influence how physicians can optimize watch-and-wait strategies for common, subjective symptoms. The current study aims to dramatically expand what we know about OLP by comparing, for the first time, OLP and DBP administration. Adopting a unique, multidisciplinary approach, the study also explores genetic, psychological and experiential dimensions of OLP. The paper ends with an extensive discussion of the “culture” of the trial as well as potential mechanisms of OLP and ethical implications. Trial registration ClinicalTrials.gov, identifier: NCT02802241. Registered on 14 June 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1964-x) contains supplementary material, which is available to authorized users.Publication Heart Rate Fragmentation: A New Approach to the Analysis of Cardiac Interbeat Interval Dynamics(Frontiers Media S.A., 2017) Costa, Madalena; Davis, Roger; Goldberger, AryBackground: Short-term heart rate variability (HRV) is most commonly attributed to physiologic vagal tone modulation. However, with aging and cardiovascular disease, the emergence of high short-term HRV, consistent with the breakdown of the neuroautonomic-electrophysiologic control system, may confound traditional HRV analysis. An apparent dynamical signature of such anomalous short-term HRV is frequent changes in heart rate acceleration sign, defined here as heart rate fragmentation. Objective: The aims were to: (1) introduce a set of metrics designed to probe the degree of sinus rhythm fragmentation; (2) test the hypothesis that the degree of fragmentation of heartbeat time series increases with the participants' age in a group of healthy subjects; (3) test the hypothesis that the heartbeat time series from patients with advanced coronary artery disease (CAD) are more fragmented than those from healthy subjects; and (4) compare the performance of the new fragmentation metrics with standard time and frequency domain measures of short-term HRV. Methods: We analyzed annotated, open-access Holter recordings (University of Rochester Holter Warehouse) from healthy subjects and patients with CAD using these newly introduced metrics of heart rate fragmentation, as well as standard time and frequency domain indices of short-term HRV, detrended fluctuation analysis and sample entropy. Results: The degree of fragmentation of cardiac interbeat interval time series increased significantly as a function of age in the healthy population as well as in patients with CAD. Fragmentation was higher for the patients with CAD than the healthy subjects. Heart rate fragmentation metrics outperformed traditional short-term HRV indices, as well as two widely used nonlinear measures, sample entropy and detrended fluctuation analysis short-term exponent, in distinguishing healthy subjects and patients with CAD. The same level of discrimination was obtained from the analysis of normal-to-normal sinus (NN) and cardiac interbeat interval (RR) time series. Conclusion: The fragmentation framework and accompanying metrics introduced here constitute a new way of assessing short-term HRV under free-running conditions, one which appears to overcome salient limitations of traditional HRV analysis. Fragmentation of sinus rhythm cadence may provide new dynamical biomarkers for probing the integrity of the neuroautonomic-electrophysiologic network controlling the heartbeat in health and disease.Publication A Treatment Trial of Acupuncture in IBS Patients(Nature Publishing Group, 2009) Lembo, Anthony; Conboy, Lisa; Kelley, John; Schnyer, Rosa S; McManus, Claire A; Quilty, Mary T; Kerr, Catherine; Drossman, Doug; Jacobson, Eric; Davis, Roger; Kaptchuk, TedObjective: To compare the effects of true and sham acupuncture in relieving symptoms of IBS. Methods: A total of 230 adult IBS patients (75% females, average age 38.4 yrs) were randomly assigned to 3 weeks of true or sham acupuncture (6 treatments) following a 3 week ‘run-in’ with sham acupuncture in an ‘augmented’ or ‘limited’ patient-practitioner interaction. A third arm of the study included a waitlist control group. The primary outcome was the IBS Global Improvement Scale (IBS-GIS) (range 1–7); secondary outcomes included IBS Symptom Severity Scale (IBS-SSS), Adequate Relief (IBS-AR) and IBS-Quality of life (IBS-QOL). Results: Though there was no statistically significant difference between acupuncture and sham acupuncture on the IBS-GIS (41% vs. 32%, p=0.25), both groups improved significantly compared to the wait list control group (37% vs. 4%, p=0.001). Similarly, small differences that were not statistically significant favored acupuncture on the other three outcomes: IBS-AR (59% vs 57%, p=0.83), IBS-SSS (31% vs 21%, p=0.18) and IBS-QOL (17% vs 13%, p=0.56). Eliminating responders during the run-in period did not substantively change the results. Side effects were generally mild and only slightly greater in the acupuncture group. Conclusion: This study did not find evidence to support the superiority of acupuncture compared to sham acupuncture in the treatment of IBS.Publication Preventability of early vs. late readmissions in an academic medical center(Public Library of Science, 2017) Graham, Kelly; Dike, Ogechi; Doctoroff, Lauren; Jupiter, Marisa; Vanka, Anita; Davis, Roger; Marcantonio, EdwardBackground: It is unclear if the 30-day unplanned hospital readmission rate is a plausible accountability metric. Objective: Compare preventability of hospital readmissions, between an early period [0–7 days post-discharge] and a late period [8–30 days post-discharge]. Compare causes of readmission, and frequency of markers of clinical instability 24h prior to discharge between early and late readmissions. Design, setting, patients 120 patient readmissions in an academic medical center between 1/1/2009-12/31/2010 Measures Sum-score based on a standard algorithm that assesses preventability of each readmission based on blinded hospitalist review; average causation score for seven types of adverse events; rates of markers of clinical instability within 24h prior to discharge. Results: Readmissions were significantly more preventable in the early compared to the late period [median preventability sum score 8.5 vs. 8.0, p = 0.03]. There were significantly more management errors as causative events for the readmission in the early compared to the late period [mean causation score [scale 1–6, 6 most causal] 2.0 vs. 1.5, p = 0.04], and these errors were significantly more preventable in the early compared to the late period [mean preventability score 1.9 vs 1.5, p = 0.03]. Patients readmitted in the early period were significantly more likely to have mental status changes documented 24h prior to hospital discharge than patients readmitted in the late period [12% vs. 0%, p = 0.01]. Conclusions: Readmissions occurring in the early period were significantly more preventable. Early readmissions were associated with more management errors, and mental status changes 24h prior to discharge. Seven-day readmissions may be a better accountability measure.