Showing papers by "Marcia A. Ciol published in 2022"

Effects of Hypnosis vs Mindfulness Meditation vs Education on Chronic Pain Intensity and Secondary Outcomes in Veterans: A Randomized Clinical Trial.

Abstract: ABSTRACT Effective, rigorously evaluated nonpharmacological treatments for chronic pain are needed. This study compared the effectiveness of training in hypnosis (HYP) and mindfulness meditation (MM) to an active education control (ED). Veterans (N=328) were randomly assigned to 8 manualized, group-based, in-person sessions of HYP (n = 110), MM (n = 108), or ED (n = 110). Primary (average pain intensity; API) and secondary outcomes were assessed at pretreatment, posttreatment, and 3- and 6-months posttreatment. Treatment effects were evaluated using linear regression, a generalized estimating equation approach, or a Fisher exact test, depending on the variable. There were no significant omnibus between-group differences in pre- to posttreatment change in API, however pre- to posttreatment improvements in API and several secondary variables were seen for participants in all three conditions. Participation in MM resulted in greater decreases in API and pain interference at 6-months posttreatment relative to ED. Participation in HYP resulted in greater decreases in API, pain interference, and depressive symptoms at 3- and 6-months posttreatment compared to ED. No significant differences on outcomes between HYP and MM were detected at any time point. This study suggests that all three interventions provide posttreatment benefits on a range of outcomes, but the benefits of HYP and MM continue beyond the end of treatment, while the improvements associated with ED dissipate over time. Future research is needed to determine whether the between-group differences that emerged posttreatment are reliable, whether there are benefits of combining treatments, and to explore moderating and mediating factors.

Development of the Sm14/GLA-SE Schistosomiasis Vaccine Candidate: An Open, Non-Placebo-Controlled, Standardized-Dose Immunization Phase Ib Clinical Trial Targeting Healthy Young Women

Abstract: We report the successful closure of Phase I clinical trials of the Schistosoma mansoni 14 kDa fatty acid-binding protein (Sm14) + glucopyranosyl lipid A in squalene emulsion (GLA-SE) vaccine candidate against human Schistosomiasis, comprising Phases Ia and Ib. Shown here are the results of Phase Ib, an open, not placebo-controlled, standardized-dose immunization trial, involving 10 healthy 18-49 years old women submitted to the same clinical protocol and the same batch of cGMP Sm14+GLA-SE used in Phase Ia, which was one on men. Fifty {micro}g Sm14 protein plus 10 {micro}g GLA-SE per dose were given intramuscularly thrice at 30-day intervals. Participants were assessed clinically, biochemically, and immunologically for up to 120 days. In preambular experiments involving vaccinated pregnant female rabbits, we did not find any toxicological feature either in offspring or mothers, as ascertained by histopathology and biochemical parameters. The vaccine induced adaptive immunity in the animals, as defined by the detection of anti-Sm14 antibodies in the sera. In women, neither serious nor light adverse events were observed. Sm14+GLA-SE vaccination induced high titers of anti-Sm14 serum IgG antibody production. Total anti-IgG serum levels remained high 120 days after the first vaccination dose. Significant increases in Sm14-specific total IgG, IgG1, and IgG3 were observed 30 days after the first vaccination, with specific IgG2 and IgG4 after 60 days. Sm14+GLA-SE vaccination also elicited robust cytokine responses with increased TNF, IFN{gamma}, and IL-2 profiles in all female vaccinees on days 90 and 120. As in Phase Ia, the Sm14+GLA-SE vaccine was shown to be strongly immunogenic and well tolerated. The completion of Phase I clinical trials performed to the highest standards set by the Good Clinical Research Practice (GCP) standards and pre-clinical data in pregnant rabbits enabled the vaccine candidate to proceed to Phase II clinical trials in endemic areas.

Implementation of a Physical Activity Vital Sign in Primary Care: Associations Between Physical Activity, Demographic Characteristics, and Chronic Disease Burden.

Abstract: INTRODUCTION Physical activity is important to prevent and manage multiple chronic medical conditions. The objective of this study was to describe the implementation of a physical activity vital sign (PAVS) in a primary care setting and examine the association between physical activity with demographic characteristics and chronic disease burden. METHODS We extracted data from the electronic medical records of patients who had visits from July 2018 through January 2020 in a primary care clinic in which PAVS was implemented as part of the intake process. Data collected included self-reported physical activity, age, sex, body mass index, race, ethnicity, and a modified Charlson Comorbidity Index score indicating chronic disease burden. We classified PAVS into 3 categories of time spent in moderate to strenuous intensity physical activity: consistently inactive (0 min/wk), inconsistently active (<150 min/wk), and consistently active (≥150 min/wk). We used χ2 tests of independence to test for association between PAVS categories and all other variables. RESULTS During the study period, 13,704 visits, corresponding to 8,741 unique adult patients, had PAVS recorded. Overall, 18.1% of patients reported being consistently inactive, 48.3% inconsistently active, and 33.7% consistently active. All assessed demographic and clinical covariates were associated with PAVS classification (all P < .001). Larger percentages of consistent inactivity were reported for female, older, and underweight or obese patients. Larger percentages of consistent activity were reported for male, younger, and normal weight or overweight patients. CONCLUSION Using PAVS as a screening tool in primary care enables physicians to understand the physical activity status of their patients and can be useful in identifying inactive patients who may benefit from physical activity counseling.

Performance of an auto-adjusting prosthetic socket during walking with intermittent socket release

Abstract: Introduction A challenge in the engineering of auto-adjusting prosthetic sockets is to maintain stable operation of the control system while users change their bodily position and activity. The purpose of this study was to test the stability of a socket that automatically adjusted socket size to maintain fit. Socket release during sitting was conducted between bouts of walking. Methods Adjustable sockets with sensors that monitored distance between the liner and socket were fabricated. Motor-driven panels and a microprocessor-based control system adjusted socket size during walking to maintain a target sensed distance. Limb fluid volume was recorded continuously. During eight sit/walk cycles, the socket panels were released upon sitting and then returned to position for walking, either the size at the end of the prior bout or a size 1.0% larger in volume. Results In six transtibial prosthesis users, the control system maintained stable operation and did not saturate (move to and remain at the end of the actuator’s range) during 98% of the walking bouts. Limb fluid volume changes generally matched the panel position changes executed by the control system. Conclusions Stable operation of the control system suggests that the auto-adjusting socket is ready for testing in users’ at-home settings.

Perceived Community Participation and Associated Factors in People With Stroke

Abstract: To examine individual- and environmental-level factors associated with perceived participation performance and satisfaction in people with chronic stroke. Cross-sectional study using secondary data analysis of baseline data from a randomized controlled trial. Community-based setting. Community-dwelling adults with mild to moderate stroke (N=113; mean age=57 years; 58 males). Not applicable. Main outcomes were measured with the Reintegration to Normal Living Index (perceived participation performance) and Patient-Reported Outcome Measure Information System satisfaction with participation in social roles (perceived participation satisfaction). Other variables collected included personal (eg, age, perceived recovery), health-related (eg, time since stroke, number of comorbidities), body function–related (eg, Stroke Impact Scale, Center for Epidemiologic Studies Depression Scale), and environmental (eg, World Health Organization Quality of Life Short Form Environmental subscale) data. Depression, fatigue, mobility, and environmental support showed moderate to strong, statistically significant associations with participation performance and satisfaction in people with stroke. Perceived recovery was moderately associated with participation performance but not with participation satisfaction. Returning to participation is a complex process after stroke. Results suggest that various personal, body function–related, and environmental factors are associated with participation performance and satisfaction.

Effect of an educational program on physical activity in individuals undergoing their first percutaneous coronary intervention: A randomized clinical trial.

Abstract: Educational programs designed for specific populations to improve regular physical activity need to be tested.To evaluate the effectiveness of an educational program, when compared to usual care, on improving physical activity 5 to 7 months after hospital discharge in adult patients undergoing their first percutaneous coronary intervention.Randomized controlled trial with two groups: usual care (n = 56) and educational program (n = 53) interventions. Data on sociodemographic and clinical characteristics were collected and the Baecke-Habitual Physical Activity Questionnaire, Self-efficacy Scale for Physical Activity, and Hospital Anxiety and Depression Scale were administered at baseline and follow-up. Participants in the educational program received an intervention based on Social Cognitive Theory, focused on physical activity, followed by three telephone calls. The usual care group received the hospital routine information. Unadjusted and adjusted differences between the two groups in mean score changes (with 95% confidence intervals [CI]) were calculated for all outcomes.At follow-up, the educational program group showed higher mean ± standard deviation scores than the usual care group for practice of physical activity (7.94 ± 1.84 vs. 6.90 ± 1.89) and for self-efficacy (3.98 ± 3.75 vs. 2.52 ± 3.12). Adjusting for baseline outcome, the difference in mean change between groups was 0.89 (95% CI: 0.32, 1.46) for physical activity and 2.30 (95% CI: 1.12, 3.49) for self-efficacy. There were no statistical differences between groups in symptoms of anxiety and depression.The educational program may be an effective intervention in increasing habitual physical activity and self-efficacy for physical activity in individuals with coronary artery disease.

Evaluation of a peripheral vein for intravenous chemotherapy: a prospective observational study

Abstract: This study aimed to assess over time alterations of a peripheral vein used for chemotherapy infusion in patients with breast cancer. It is a prospective observational study which included patients who were scheduled to receive peripheral infusion of chemotherapy. These patients had the first peripheral vein used for infusion evaluated in five moments: before the venipuncture, after device removal at the end of the first chemotherapy infusion, and on days 21, 42, and 63 after the first infusion. The primary outcome was the caliber of the vein, measured in millimeters with a Veinlite LEDX® transilluminator and a tape measure. Fifty-nine women receiving doxorubicin and docetaxel for the first time were enrolled to the study. The caliber size varied from 2 to 4 millimeters at baseline, and decreased overtime. During the follow-up period, peripheral veins of 35 women (59.3%) were measured at 0 mm at day 63. The remaining 24 women (40.7%) had some recovery, but for 15 of them (62.5%) the vein became a palpable cord. The feasibility of using a peripheral vein to perform chemotherapy decreased as the treatment progresses. Este estudio tuvo como objetivo evaluar las alteraciones en el tiempo de una vena periférica utilizada para la infusión de quimioterapia en pacientes con cáncer de mama. Es un estudio observacional prospectivo que incluyó pacientes que estaban programados para recibir infusión periférica de quimioterapia. A estos pacientes se les evaluó la primera vena periférica utilizada para la infusión en cinco momentos: antes de la venopunción, después de la extracción del dispositivo al final de la primera infusión de quimioterapia y los días 21, 42 y 63 después de la primera infusión. El resultado primario fue el calibre de la vena, medido en milímetros con un transiluminador Veinlite LEDX® y una cinta métrica. Se inscribieron en el estudio 59 mujeres que recibieron doxorrubicina y docetaxel por primera vez. El tamaño del calibre varió de 2 a 4 milímetros en la línea de base y disminuyó con el tiempo. Durante el período de seguimiento, las venas periféricas de 35 mujeres (59,3%) se midieron a 0 mm el día 63. Las 24 mujeres restantes (40,7%) tuvieron cierta recuperación, pero para 15 de ellas (62,5%) la vena se convirtió en un cordón palpable. La viabilidad de utilizar una vena periférica para realizar quimioterapia disminuyó a medida que avanzaba el tratamiento. Este estudo teve como objetivo avaliar as alterações ao longo do tempo de uma veia periférica utilizada para infusão de quimioterapia em pacientes com câncer de mama. Trata-se de um estudo observacional prospectivo que incluiu pacientes que tinham indicação de receber infusão periférica de quimioterapia. A primeira veia periférica utilizada para infusão de quimioterapia nessas pacientes foi avaliada em cinco momentos: antes da punção venosa, após a retirada do dispositivo ao final da primeira infusão de quimioterapia e nos dias 21, 42 e 63 após a primeira infusão. O desfecho primário foi o calibre da veia, mensurado em milímetros com um iluminador transdérmico chamado Veinlite LEDX® e uma fita métrica. Cinquenta e nove mulheres que receberam doxorrubicina e docetaxel pela primeira vez foram incluídas no estudo. O tamanho do calibre variou de 2 a 4 milímetros no início do estudo e diminuiu com o tempo. Durante o período de acompanhamento, as veias periféricas de 35 mulheres (59,3%) foram medidas a 0 mm no dia 63. As 24 mulheres restantes (40,7%) tiveram alguma recuperação, mas para 15 delas (62,5%) a veia tornou-se um cordão palpável. A viabilidade do uso de uma veia periférica para a realização da quimioterapia diminuiu com o avanço do tratamento.