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The COVID-19 pandemic presented unprecedented challenges to patients, family members, and healthcare staff that resulted in increased stress and isolation and decreased quality of life. We evaluate the impact of a novel virtual concert program, the Vital Sounds Initiative (VSI) of Project: Music Heals Us (PMHU), which began at the beginning of the pandemic to combat patient isolation and provide employment to professional musicians. Using a qualitative analysis of VSI data, we examined post-concert written responses by musicians. These responses were coded by independent coders via inductive coding and thematic analysis. Between 7 April 2020 and 20 July 2022, 192 musicians played 2203 h of music for 11,222 audience members in 39 care facilities nationwide. A total of 114 musicians submitted a total of 658 responses. Three main themes (with corresponding subthemes) arose: (1) Patient Experience; (2) Musician Experience; (3) Caregiver (family or staff) Experience. The responses offered valuable insight into the overwhelmingly positive aspects of the virtual concerts. Overall, we found that VSI favorably impacts individuals at every level, including the patients, musician, and caregivers. These findings provide preliminary evidence for the benefits of virtual music concerts. Upscaling similar virtual music interventions/programs should be considered.
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Shared decision making (SDM) has been advocated to improve patient care, patient decision acceptance, patient-provider communication, patient motivation, adherence, and patient reported outcomes. Documentation of SDM is endorsed in several society guidelines and is a condition of reimbursement for selected cardiovascular and cardiac arrhythmia procedures. However, many clinicians argue that SDM already occurs with clinical encounter discussions or the process of obtaining informed consent and note the additional imposed workload of using and documenting decision aids without validated tools or evidence that they improve clinical outcomes. In reality, SDM is a process and can be done without decision tools, although the process may be variable. Also, SDM advocates counter that the low-risk process of SDM need not be held to the high bar of demonstrating clinical benefit and that increasing the quality of decision making should be sufficient. Our review leverages a multidisciplinary group of experts in cardiology, cardiac electrophysiology, epidemiology, and SDM, as well as a patient advocate. Our goal is to examine and assess SDM methodology, tools, and available evidence on outcomes in patients with heart rhythm disorders to help determine the value of SDM, assess its possible impact on electrophysiological procedures and cardiac arrhythmia management, better inform regulatory requirements, and identify gaps in knowledge and future needs.
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Arritmias Cardíacas/terapia , Tomada de Decisão Clínica , Tomada de Decisão Compartilhada , Técnicas de Apoio para a Decisão , Técnicas Eletrofisiológicas Cardíacas , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/fisiopatologia , Medicina Baseada em Evidências , Humanos , Participação do Paciente , Segurança do Paciente , Valor Preditivo dos Testes , Prognóstico , Medição de Risco , Fatores de RiscoRESUMO
Importance: Chronic low back pain has high societal and personal impact but remains challenging to treat. Electroacupuncture has demonstrated superior analgesia compared with placebo in animal studies but has not been extensively studied in human chronic pain conditions. Objective: To evaluate the treatment effect of real electroacupuncture vs placebo in pain and disability among adults with chronic low back pain and to explore psychophysical, affective, and demographic factors associated with response to electroacupuncture vs placebo in treating chronic low back pain. Design, Setting, and Participants: This double-blind randomized clinical trial was conducted between August 2, 2016, and December 18, 2018, at a single center in Stanford, California. Primary outcomes were collected at approximately 2 weeks before and after intervention. Participants included English-speaking adults with at least 6 months of chronic low back pain, pain intensity of at least 4 on a scale of 0 to 10, and no radiculopathy. Data analyses for this intent-to-treat study were conducted from June 2019 to June 2020. Interventions: Twelve sessions of real or placebo (sham) electroacupuncture administered twice a week over 6 weeks. Main Outcomes and Measures: The main outcome was change in pain severity from baseline to 2 weeks after completion of treatment, measured by the National Institutes of Health PROMIS pain intensity scale. A secondary outcome was change in the Roland Morris Disability Questionnaire (RMDQ). Baseline factors potentially associated with these outcomes included psychophysical testing (ie, thermal temporal summation, conditioned pain modulation, pressure pain threshold), participant's self-report (ie, widespread pain, coping strategies, expectations, self-efficacy, and pain catastrophizing), and demographic characteristics (eg, age, sex, and race). Results: A total of 121 adults were recruited to the study, among whom 59 participants (mean [SD] age, 46.8 [11.9] years; 36 [61.0%] women) were randomized to real electroacupuncture and 62 participants (mean [SD] age, 45.6 [12.8] years; 33 [53.2%] women) were randomized to sham electroacupuncture. At baseline, the mean (SD) PROMIS T-score was 50.49 (3.36) in the real electroacupuncture group and 51.71 (4.70) in the sham acupuncture group, and the mean (SD) RMDQ score was 10.16 (4.76) in the real electroacupuncture group and 10.03 (5.45) in the sham acupuncture group. After adjusting for baseline pain scores, there was no statistically significant difference between groups in change in T-scores 2 weeks after completion of treatment (real electroacupuncture: -4.33; 95% CI, -6.36 to -2.30; sham acupuncture: -2.90; 95% CI, -4.85 to -0.95; difference: -2.09; 95% CI, -4.27 to 0.09; P = .06). After adjusting for baseline RMDQ, there was a significantly greater reduction in RMDQ in the real electroacupuncture group (-2.77; 95% CI, -4.11 to -1.43) compared with the sham electroacupuncture group (-0.67; 95% CI, -1.88 to 0.55; difference: -2.11; 95% CI, -3.75 to -0.47; P = .01). Within the real electroacupuncture group, effective coping at baseline was associated with greater RMDQ reduction (r = -0.32; 95% CI, -0.54 to -0.05; P = .02), and White race was associated with worse outcomes in PROMIS score (ß = 3.791; 95% CI, 0.616 to 6.965; P = .02) and RMDQ (ß = 2.878; 95% CI, 0.506 to 5.250; P = .02). Conclusions and Relevance: This randomized clinical trial found no statistically significant difference in change in PROMIS pain score in real electroacupuncture vs sham electroacupuncture. There was a statistically significant treatment effect for the secondary outcome of RMDQ compared with sham electroacupuncture. Effective coping skills and non-White race were associated with response to electroacupuncture. Trial Registration: ClinicalTrials.gov Identifier: NCT02890810.
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Eletroacupuntura/normas , Dor Lombar/terapia , Manejo da Dor/normas , Placebos/normas , Adulto , Idoso , California , Método Duplo-Cego , Eletroacupuntura/métodos , Eletroacupuntura/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Manejo da Dor/métodos , Manejo da Dor/estatística & dados numéricos , Medição da Dor/métodos , Resultado do TratamentoRESUMO
BACKGROUND: Although modifiable cardiovascular disease risk factors are common, some patients eschew conventional drug treatments in favor of natural alternatives. Pine bark extract, a dietary supplement source of antioxidant oligomeric proanthocyanidin complexes, has multiple putative cardiovascular benefits. Studies published to date about the supplement have notable methodological limitations. METHODS: We randomized 130 individuals with increased cardiovascular disease risk to take 200 mg of a water-based extract of pine bark (n = 64; Toyo-FVG, Toyo Bio-Pharma, Torrance, California; Shinyaku Co, Ltd, Saga, Japan; also marketed as Flavagenol in Japan) or placebo (n = 66) once per day. Blood pressure, our primary outcome, and other cardiovascular disease risk factors were measured at baseline and at 6 and 12 weeks. Statistical analyses were conducted using regression models. RESULTS: Baseline characteristics did not differ between the study groups. Over the 12-week intervention, the sum of systolic and diastolic blood pressures decreased by 1.0 mm Hg (95% confidence interval, -4.2 to 2.1 mm Hg) in the pine bark extract-treated group and by 1.9 mm Hg (-5.5 to 1.7 mm Hg) in the placebo group (P = .87). Other outcomes were likewise not significantly different, including body mass index, lipid panel measures, liver transaminase test results, lipoprotein cholesterol particle size, and levels of insulin, lipoprotein(a), fasting glucose, and high-sensitivity C-reactive protein. There were no subgroups for whom intake of pine bark extract affected cardiovascular disease risk factors. CONCLUSIONS: This pine bark extract (at a dosage of 200 mg/d) was safe but was not associated with improvement in cardiovascular disease risk factors. Although variations among participants, dosages, and chemical preparations could contribute to different findings compared with past studies, our results are consistent with a general failure of antioxidants to demonstrate cardiovascular benefits. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00425945.
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Antioxidantes/uso terapêutico , Doenças Cardiovasculares/prevenção & controle , Fitoterapia , Pinus/química , Casca de Planta/química , Extratos Vegetais/uso terapêutico , Antioxidantes/farmacologia , Índice de Massa Corporal , Método Duplo-Cego , Humanos , Obesidade/complicações , Obesidade/tratamento farmacológico , Sobrepeso/complicações , Sobrepeso/tratamento farmacológico , Extratos Vegetais/farmacologia , Fatores de Risco , Resultado do TratamentoRESUMO
BACKGROUND: In China and Taiwan, Complementary and Alternative Medicine (CAM) therapies such as traditional Chinese medicine have been an option to cancer patients for centuries, whereas in the United States, CAM has been growing in popularity only in the past few decades. Prior research has indicated that the prevalence of CAM use among cancer patients may exceed 80%. Because of a long cultural history of CAM, we hypothesized that oncologists in China and Taiwan (C/T) would communicate and combine CAM with conventional treatments more often than US oncologists. METHODS: In 2004-2005, a convenience sample of oncologists from the United States, mainland China, and Taiwan were surveyed regarding their opinions and self-reported practice patterns regarding CAM. RESULTS: A total 95 oncologists returned surveys, providing a 38% response rate. Four out of 5 respondents (78%) felt their medical training was inadequate to use CAM. However, 70% reported they would allow CAM use during active cancer treatment, even in the setting of curable disease. Responding C/T oncologists tended to ask patients more frequently (they ask > 25% of patients) about CAM use and recommended CAM more commonly (recommend to > 10%) to patients than surveyed US oncologists, 55% versus 37% (P = .09) and 81% versus 53% (P < .05). Respondents from the United States felt no more prepared for CAM use than C/T respondents, but 70% reported willingness to combine CAM with conventional treatments for curable disease as compared with only 48% (P < .05) of C/T oncologists. CONCLUSIONS: As expected, responding C/T oncologists communicate more often about CAM with patients by asking and recommending CAM. However, contrary to our original hypothesis, C/T oncologists reported a much lower rate of combining CAM with conventional treatment among curable patients than responding US oncologists. Further research is needed to explore, in depth, the reasons for differences in CAM practice patterns among oncologists.
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Atitude do Pessoal de Saúde/etnologia , Terapias Complementares/estatística & dados numéricos , Neoplasias/terapia , Padrões de Prática Médica , Adulto , California , China , Feminino , Humanos , Illinois , Masculino , Oncologia , Pessoa de Meia-Idade , Projetos Piloto , Inquéritos e Questionários , TaiwanRESUMO
BACKGROUND: Recent research has raised doubts about the efficacy of calcium supplementation in preventing fractures; however, adequate calcium intake remains important. OBJECTIVE: Using data from the 1999-2002 National Health and Nutrition Examination Survey, we assessed dietary and supplemental calcium consumption among US men and women according to risk of osteoporosis and stratified by sex, race/ethnicity, and socioeconomic status. DESIGN: We categorized risk of osteoporosis as high (having an osteoporosis diagnosis or treatment), moderate (aged >50 y), or low (aged 19-50 y). Main study outcomes included milligrams of dietary and supplemental calcium intake, likelihood of meeting national calcium adequate intake (AI) levels, and likelihood of taking supplemental calcium. RESULTS: Mean (95% CI) total calcium consumption was 944 (846, 1043) mg in the high-risk group, 821 (788, 854) mg in the moderate-risk group, and 846 (812, 871) mg in the low-risk group. Overall, 40% of the sample met the calcium AI amount and 48% reported taking supplemental calcium. After adjustment for daily caloric intake, the greater likelihood of meeting calcium AI levels was associated with [odds ratio (95% CI)] low [versus moderate, 1.5 (1.2, 1.7)] and high [versus moderate, 1.9 (1.3, 2.6)] osteoporosis risk, female sex [1.6 (1.3, 1.8)], non-Hispanic white ethnicity [versus nonwhite, 1.9 (1.7, 2.3)], and education beyond high school [versus less than high school, 1.5 (1.2, 1.9)]. These same factors were also associated with an increased likelihood of taking supplemental calcium, except for a consistent increase with higher osteoporosis risk. CONCLUSION: Many Americans--particularly men, ethnic minorities, and the socially disadvantaged--are not meeting the current recommendations for adequate calcium intake through diet alone or with supplements.
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Conservadores da Densidade Óssea/administração & dosagem , Cálcio da Dieta/administração & dosagem , Política Nutricional , Necessidades Nutricionais , Osteoporose/prevenção & controle , Adulto , Dieta , Suplementos Nutricionais/estatística & dados numéricos , Etnicidade , Feminino , Inquéritos Epidemiológicos , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos Nutricionais , Osteoporose/epidemiologia , Osteoporose/etiologia , Fatores Sexuais , Fatores Socioeconômicos , Estados UnidosRESUMO
OBJECTIVE: Women increasingly use alternative therapies for menopause symptom relief. We examined 1) current use and perceptions of hormone and alternative therapies for symptom relief among US women, and 2) healthcare provider involvement in women's decision making. DESIGN: An online survey was completed by a national sample of 781 US women aged 40 to 60 years (72% survey completion rate) drawn from the Knowledge Networks panel in June 2004. Nationally representative estimates of women's use and perceptions of hormone and alternative therapies were made by accounting for sampling weights and survey design. RESULTS: Hormone therapy was reported among 263 or 37% of this largely symptomatic sample, of whom 59% had stopped primarily due to concern about its potential risks. Herbal products and soy supplements separately were used among 31% and 13% of symptomatic women, of whom 41% and 67% were current users. Forty-four percent of herb users considered these products helpful with symptom relief. Sampled women generally felt ill informed about proper doses and usage of herbal products. Also, 58% of the sampled women expressed at least some concerns about these products, whereas proven safety was the most important factor when women consider such products. Despite considering healthcare providers the most reliable source of information, sampled women expressed low confidence in their ability to give sufficient information about treatment options for menopause symptoms. CONCLUSIONS: Alternative therapies have become increasing popular and are quickly approaching hormone therapy in frequency as therapies for symptom relief among menopause-age women in the United States. However, large gaps exist between patient expectations and provider preparedness to guide patient decision making.
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Terapias Complementares , Terapia de Reposição de Estrogênios , Fogachos/terapia , Menopausa , Relações Médico-Paciente , Adulto , Tomada de Decisões , Feminino , Pesquisas sobre Atenção à Saúde , Fogachos/patologia , Humanos , Serviços de Informação , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde , Educação de Pacientes como Assunto , Fitoterapia , Inquéritos e Questionários , Estados UnidosRESUMO
OBJECTIVE: Although calcium intake is considered integral to appropriate management of osteoporosis, we hypothesized that the recent therapeutic dominance of bisphosphonates in osteoporosis treatment may have led calcium to be neglected as a component of effective management. STUDY DESIGN: Two national databases were used to assess the adequacy of calcium intake in patients with osteoporosis. Trends in reported supplemental calcium use among physician visits by patients with osteoporosis were assessed using nationally representative 1994-2004 IMS HEALTH National Disease and Therapeutic Index data. Quantity of calcium intake, from both supplements and food, among individuals with osteoporosis (n = 38 men and 376 women) was estimated using the 1999-2002 National Health and Nutrition Examination Survey (NHANES). RESULTS: Physician visits for osteoporosis in the United States increased 4.5-fold between 1994 (1.3 million visits) and 2004 (5.8 million visits). During this time the proportion of osteoporosis visits in which bisphosphonates were prescribed increased from 14% to 81%, while reported calcium use fell from 43% to 23% of visits. Among osteoporosis patients in NHANES, 64% reported using calcium-containing supplements. Reported median calcium intake was 433 (interquartile range: 295, 705) mg/d for calcium supplement nonusers and 1,319 (845, 1,874) mg for calcium supplement users. Overall, only 40% of osteoporosis patients had calcium intake exceeding 1,200 mg/d. CONCLUSION: While osteoporosis is increasingly identified and treated with effective medications, calcium is being neglected as a component of osteoporosis management. Despite the fact that the efficacy of new osteoporosis medications depends on adequate calcium intake, reported calcium intake in osteoporosis patients is far below recommended levels.