Effectiveness of pharmaceutical care for drug treatment adherence in women with lupus nephritis in Rio de Janeiro, Brazil: a randomized controlled trial

Lupus ◽  
2019 ◽  
Vol 28 (11) ◽  
pp. 1368-1377
Author(s):  
M Oliveira-Santos ◽  
J F S Verani ◽  
L A B Camacho ◽  
C A F de Andrade ◽  
E M Klumb
Keyword(s):  
Lupus Nephritis ◽  
Drug Treatment ◽  
Pharmaceutical Care ◽  
Treatment Adherence ◽  
Rio De Janeiro ◽  
Protocol Analysis ◽  
Intervention Group ◽  
Control Group ◽  
Intention To Treat ◽  
Treat Analysis

Objective Studies have been conducted to determine the causal factors and clinical consequences of non-adherence to treatment in systemic lupus erythematosus (SLE). However, no interventions have been performed to increase drug adherence. Our objective was to assess the effectiveness of pharmaceutical care (PC) for drug treatment adherence in lupus nephritis (LN). Methods This was a randomized clinical trial (pragmatic trial) in patients with LN in Rio de Janeiro, Brazil, allocated in two groups: an intervention group (Dader Method for PC) and a control group (institution's usual care). Drug treatment adherence was measured by the combination of five questions normally used in clinical practice. Results A total of 131 patients were randomized, and 122 completed the study, with a mean follow-up of 12.7 months and use of six drugs per day and 10–12 doses per day. Low adherence was observed at baseline (intervention group: 30%; control group: 29%). PC showed 27% effectiveness (95% confidence interval (CI) –6% to 50%) in the intention to treat analysis and 31% (95% CI 0–52%) in per protocol analysis, considering all drugs. As for adherence to specific drugs for SLE, effectiveness of PC was 64% (95% CI 34–80%) with intention-to-treat analysis and 62% (95% CI 32–79%) in per protocol analysis. Conclusions PC was effective for increasing drug treatment adherence in SLE. The detailed account provided by the Dader Method of the difficulties with patients' drug therapy proved invaluable to approach non-adherence.

Acupuncture Vs Streitberger Needle in Knee Osteoarthritis – An Rct

2006 ◽  
Vol 24 (1_suppl) ◽  
pp. 15-24 ◽  
Author(s):  
Jorge Vas ◽  
Camila Méndez ◽  
Emilio Perea-Milla
Keyword(s):  
Protocol Analysis ◽  
Controlled Trial ◽  
Multiple Linear Regression Model ◽  
Chronically Ill ◽  
Visual Analogue Scale Pain ◽  
Control Group ◽  
Osteoarthritis Of The Knee ◽  
Clinical Variables ◽  
Intention To Treat ◽  
Treat Analysis

Aims To determine the effectiveness of acupuncture as a therapy complementary to the pharmacological treatment of osteoarthritis of the knee. Methods Randomised, single blind, placebo controlled trial. Patients with osteoarthritis of the knee were randomly assigned to either 12 sessions of true acupuncture or 12 sessions of placebo acupuncture (Streitberger needle), these sessions taking place once a week. A baseline measurement was carried out, followed by further observations at 4, 8, 12 and 16 weeks. The clinical variables were the WOMAC (Western Ontario and McMaster Universities Osteoarthritis) index, knee pain measured by a visual analogue scale (pain VAS), the weekly consumption of diclofenac and the Profile of the Quality of Life of the Chronically Ill (PQLC). The two groups were compared for each of the clinical variables per protocol and by intention to treat. A multiple linear regression model for the dependent variables was constructed. Results Ninety seven outpatients were selected, with 88 remaining for the per protocol analysis; the analysis of homogeneity concluded that the lost subjects were not significantly different from those that completed the study. The multivariate per protocol model for the relative pain VAS variable showed a difference in improvement of 43.7% (95% CI 29.4% to 58.0%) for acupuncture, compared with the control group. In an intention to treat analysis, the relative improvement was 32.4% (20.3% to 44.4%). In a per protocol analysis, the total WOMAC showed a relative decrease of 52.0% (34.3% to 69.6%) in favour of the acupuncture group, or 37.6% (22.4% to 52.8%) in an intention to treat analysis. Conclusions The group treated with acupuncture showed significantly better effects, both clinically and statistically, in the reduction of pain intensity as measured by pain VAS, on the WOMAC index and in decreased consumption of diclofenac.

scholarly journals Internet-Based Cognitive Behavior Therapy for Stress and Anxiety among Young Japanese Adults: A Preliminary Study

Psych ◽  
2019 ◽  
Vol 1 (1) ◽  
pp. 353-363 ◽  
Author(s):  
Kentaro Shirotsuki ◽  
Saki Uehara ◽  
Shohei Adachi ◽  
Mutsuhiro Nakao
Keyword(s):  
Behavior Therapy ◽  
Cognitive Behavior Therapy ◽  
Intervention Group ◽  
Control Group ◽  
Cognitive Behavior ◽  
Intention To Treat ◽  
Japanese Adults ◽  
Moderate Effect Size ◽  
Preliminary Study ◽  
Treat Analysis

In the present study, we examined the effect of an internet cognitive behavior therapy (ICBT) program on anxiety, stress, and depressive symptoms in university students. Data were analyzed for 17 participants undergoing ICBT and 11 control group participants. An ANOVA of intention-to-treat analysis and per protocol (PP) analysis indicated that the interaction between group and measurement time was significant for the state–trait anxiety inventory (STAI) scores and that idiosyncratic anxiety was significantly improved. Through the results of PP, a moderate effect size for changes in STAI scores in the intervention group was observed (d = 0.62) based on Cohen’s (1988) classifications. A large effect was also observed for improvements in idiosyncratic anxiety (d = 0.91). Based on the results of the analyses, a significant interaction was observed for the STAI scores. In the intervention group, STAI scores and individual anxiety were significantly reduced after implementing the ICBT program. It was suggested that the ICBT program may positively influence thinking about anxiety and stress from an objective viewpoint.

scholarly journals Comparison of Endoscopic Injection of Botulinum Toxin and Steriods Immediately after Endoscopic Submucosal Dissection to Prevent Esophageal Stricture: A Prospective Cohort Study

2021 ◽  
Author(s):  
Xiaoying Zhou ◽  
Han Chen ◽  
Meihong Chen ◽  
Chao Ding ◽  
Guoxin Zhang ◽  
...  
Keyword(s):  
Esophageal Stricture ◽  
Protocol Analysis ◽  
Control Group ◽  
Endoscopic Injection ◽  
Intention To Treat ◽  
Mucosal Defect ◽  
Esophageal Strictures ◽  
Group A ◽  
Group B ◽  
Treat Analysis

Abstract Background: Widespread endoscopic submucosal dissection (ESD) in early esophageal cancer patients is closely associated with esophageal stricture, which dramatically reduces patients’ quality of life and increases huge medical burdens. Endoscopic injection of steroid was proved as a protective method for post-ESD strictures. Other materials such as botulinum toxin type A (BTX-A) may be potential candidates. We conducted this prospective cohort study to compare the efficacy and feasibility of endoscopic injection of BTX-A and triamcinolone acetonide (TA) for the prevention of esophageal stricture.Methods: Seventy-eight patients with esophageal mucosal defects of more than two thirds of the circumference were successively enrolled and divided into 3 groups: BTX-A group (group A, n=26), TA group (group B, n=16) and control group (group C, n=36). Patients in group A were immediately injected with BTX-A after ESD, in group B were immediately injected with TA and in group C received ESD only. Endoscopy was performed when patients reported dysphagia symptoms and at 6 and 12 weeks post-ESD in patients without symptoms. Patients who experienced post-ESD esophageal strictures in all groups received bougie dilation. All patients were followed up for one year.Results: The proportion of patients developing stricture in BTX-A group was 30.00% (intention to treat analysis, 9/30) and 26.92% (per protocol analysis, 7/26), in TA group was 40.90% (intention to treat analysis, 9/22) and 43.75% (per protocol analysis, 7/16), and in control group was 84.21% (intention to treat analysis, 32/38) and 83.33% (per protocol analysis, 30/36) (p<0.001). When further comparing between each of the two groups, the incidence of esophageal stricture was lower in BTX-A group than that in control group (p<0.001), and lower in TA group than that in control group (p=0.004). Furthermore, in entire circumference mucosal defect subgroup, the esophageal stricture was significantly lower in BTX-A group than that in TA group (33.3% vs 100%, p=0.0454).Conclusions: Endoscopic injection of BTX-A and TA were effective in preventing post-ESD esophageal strictures and BTX-A injection was particularly effective in entire circumference mucosal defect patients. Multi-centered, randomized prospective study with larger sample size should be conducted. (Clinical trial registration number: ChiCTR2100042970, registered 1 February 2021, retrospectively registered, http://www.chictr.org.cn/listbycreater.aspx)

Randomized Trial for Weight Loss Using a Digital Therapeutic Application

2021 ◽  
pp. 193229682110008
Author(s):  
Tryggvi Thorgeirsson ◽  
Johanna E. Torfadottir ◽  
Erlendur Egilsson ◽  
Saemundur Oddsson ◽  
Thrudur Gunnarsdottir ◽  
...  
Keyword(s):  
Weight Loss ◽  
Mobile Application ◽  
Intervention Group ◽  
Lifestyle Change ◽  
Noncommunicable Diseases ◽  
Control Group ◽  
Intention To Treat ◽  
Protocol Group ◽  
Lifestyle Program ◽  
Program Intervention

Background: Smartphones present a near-ubiquitous channel through which structured lifestyle change can reduce risk or progression of the most common noncommunicable diseases. We explored whether a digital structured lifestyle program enhances weight loss. Methods: We randomized overweight and obese participants attending a four-month lifestyle change program to either standard weekly coaching sessions (controls), or standard treatment supplemented with a digital therapeutic mobile application (intervention). Changes in body mass index after four months were the main outcome measure. Odds ratios of achieving 5% weight loss were estimated with unconditional logistic regression. Results: Of 234 eligible persons, 146 (62%) agreed to participate, were block-randomized, showed up for the baseline measures, and constituted the intention-to-treat (ITT) sample ( n = 95 intervention group, n = 51 control group). In the intervention group, 70 (74%) downloaded the mobile application and completed the program (intervention per-protocol). Significant weight loss and BMI reduction were observed for both the intention-to-treat intervention group ( P < 0.05, P = 0.01) and the per-protocol intervention group ( P < 0.0001, P < 0.0001). For the intervention per-protocol group, the odds ratio of achieving 5% weight loss, compared to not treated per-protocol, was 3.3 (95% CI 1.3-8.2), adjusting for age and weight at baseline.Attendance to weekly coaching sessions decreased by 18% during the program in the control group while it increased by 3% amongst the per-protocol group ( P = 0.004). Conclusions: These preliminary findings support the benefit of a digital therapeutic to enhance weight reduction and attendance in a structured lifestyle change program. Larger trials of longer duration are needed to confirm these findings.

School-based obesity interventions in the metropolitan area of Rio De Janeiro, Brazil: pooled analysis from five randomised studies

2021 ◽  
pp. 1-7
Author(s):  
Renata da R. M. Rodrigues ◽  
Bruna K. Hassan ◽  
Michele R. Sgambato ◽  
Bárbara da S. N. Souza ◽  
Diana B. Cunha ◽  
...  
Keyword(s):  
Eating Habits ◽  
Intervention Group ◽  
Pooled Analysis ◽  
Control Group ◽  
Intention To Treat ◽  
School Year ◽  
School Based ◽  
Obesity Interventions ◽  
The One ◽  
And Control

Abstract School-based studies, despite the large number of studies conducted, have reported inconclusive results on obesity prevention. The sample size is a major constraint in such studies by requiring large samples. This pooled analysis overcomes this problem by analysing 5926 students (mean age 11·5 years) from five randomised school-based interventions. These studies focused on encouraging students to change their drinking and eating habits, and physical activities over the one school year, with monthly 1-h sessions in the classroom; culinary class aimed at developing cooking skills to increase healthy eating and attempts to family engagement. Pooled intention-to-treat analysis using linear mixed models accounted for school clusters. Control and intervention groups were balanced at baseline. The overall result was a non-significant change in BMI after one school year of positive changes in behaviours associated with obesity. Estimated mean BMI changed from 19·02 to 19·22 kg/m2 in the control group and from 19·08 to 19·32 kg/m2 in the intervention group (P value of change over time = 0·09). Subgroup analyses among those overweight or with obesity at baseline also did not show differences between intervention and control groups. The percentage of fat measured by bioimpedance indicated a small reduction in the control compared with intervention (P = 0·05). This large pooled analysis showed no effect on obesity measures, although promising results were observed about modifying behaviours associated with obesity.

scholarly journals The Mediterranean Eating in Scotland Experience project: evaluation of an Internet-based intervention promoting the Mediterranean diet

2005 ◽  
Vol 94 (2) ◽  
pp. 290-298 ◽  
Author(s):  
Angeliki Papadaki ◽  
Jane A. Scott
Keyword(s):  
Nutrition Education ◽  
Mediterranean Diet ◽  
Intervention Group ◽  
Saturated Fat ◽  
Hdl Cholesterol ◽  
Control Group ◽  
Monounsaturated Fat ◽  
Feedback Intervention ◽  
Intention To Treat ◽  
The Mediterranean

A 6-month intervention study with a quasi-experimental design was conducted to evaluate the effectiveness of an Internet-based, stepwise, tailored-feedback intervention promoting four key components of the Mediterranean diet. Fifty-three (intervention group) and nineteen (control group) healthy females were recruited from the Universities of Glasgow and Glasgow Caledonian, Scotland, respectively. Participants in the intervention group received tailored dietary and psychosocial feedback and Internet nutrition education over a 6-month period, while participants in the control group were provided with minimal dietary feedback and general healthy-eating brochures. Internet education was provided via an innovative Mediterranean Eating Website. Dietary changes were assessed with 7 d estimated food diaries at baseline and 6 months, and data were analysed to calculate the Mediterranean Diet Score, a composite score based on the consumption of eight components of the traditional Mediterranean diet. The ‘intention-to-treat’ analyses showed that, at 6 months, participants in the intervention group had significantly increased their intake of vegetables, fruits and legumes, as well as the MUFA:saturated fatty acid ratio in their diet, and had significantly increased plasma HDL-cholesterol levels and a reduced ratio of total:HDL-cholesterol. Participants in the control group increased their intake of legumes but showed no other favourable significant changes compared with baseline. This Internet-based, tailored-feedback intervention promoting components of the Mediterranean diet holds promise in encouraging a greater consumption of plant foods, as well as increasing monounsaturated fat and decreasing saturated fat in the Scottish diet; it also shows that the Mediterranean diet can be adopted by healthy individuals in northern European countries.

scholarly journals Effect of Inquiry-Based Stress Reduction (IBSR) Intervention on Well-Being, Resilience and Burnout of Teachers during the COVID-19 Pandemic

2021 ◽  
Vol 18 (7) ◽  
pp. 3689
Author(s):  
Tzofnat Zadok-Gurman ◽  
Ronit Jakobovich ◽  
Eti Dvash ◽  
Keren Zafrani ◽  
Benjamin Rolnik ◽  
...  
Keyword(s):  
Stress Reduction ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Stressful Events ◽  
Control Group ◽  
Subjective Well Being ◽  
Intention To Treat ◽  
School Year ◽  
Blended Intervention

Objective: The COVID-19 pandemic has had a major impact on teachers professional and personal lives. Our primary aim was to assess the effect of a blended Inquiry-Based Stress Reduction (IBSR), an emerging mindfulness and cognitive reframing intervention on teacher’s well-being. Our secondary aims were to assess the effect of IBSR on resilience, burnout, mindfulness, and stress among teachers during the COVID-19 pandemic. Methods: The study was a prospective controlled trial with an intervention group (N = 35) and a comparison control group (N = 32). The intervention took place in the Jerusalem District throughout the school year from November 2019 to May 2020. The sessions were conducted in blended learning that included traditional learning (face-to-face) and online learning. Data was analyzed on an intention-to-treat basis. Results: IBSR blended intervention enhanced the resilience and improved the subjective and psychological well-being of teachers in spite of the breakout of the COVID-19 pandemic and the first lockdown in Israel. Simultaneously the control group suffered from enhanced burnout levels and a decline in psychological and subjective well-being. Conclusions: Implementation of IBSR blended intervention during the school year may benefit teachers’ well-being and ability to flourish, even during stressful events such as the COVID-19 pandemic.

scholarly journals Effect of manual therapy in patients with hemophilia and ankle arthropathy: a randomized clinical trial

2019 ◽  
Vol 34 (1) ◽  
pp. 111-119 ◽  
Author(s):  
Elena Donoso-Úbeda ◽  
Javier Meroño-Gallut ◽  
José Antonio López-Pina ◽  
Rubén Cuesta-Barriuso
Keyword(s):  
Manual Therapy ◽  
Joint Pain ◽  
Controlled Trial ◽  
Control Group ◽  
Load Bearing ◽  
Intention To Treat ◽  
Joint Health ◽  
Experimental Group ◽  
Treat Analysis

Objective: The aim of this study was to evaluate the effects of a manual therapy using fascial therapy on joint bleeding, joint pain and joint function in patients with hemophilic ankle arthropathy. Setting: Hemophilia patient associations. Design: Randomized, controlled trial, multicenter and intention-to-treat analysis. Participants: A total of 65 patients with hemophilic ankle arthropathy. Intervention: The experimental group ( n = 33) received one fascial therapy session per week for three weeks. The control group ( n = 32) received no treatment. Outcome measure: The primary outcome was frequency of joint bleeding measured using self-reporting. Secondary outcomes were joint pain (under load-bearing and non-load-bearing conditions) measured using the visual analog scale; joint condition was measured using the Hemophilia Joint Health Score. Outcomes were measured at baseline, posttreatment and after five months of follow-up. Results: Improvements in the frequency joint bleeding at T0, T1 and T2 were significantly higher in the experimental group (T0: mean (SD) = 1.56 (1.30); T1: mean (SD) = 0.00 (0.00); T2: mean (SD) = 0.27 (0.57)) compared to the control group (T0: mean (SD) = 1.70 (1.78); T1: mean (SD) = 0.05 (0.21); T2: mean (SD) = 0.58 (0.85)). Mean improvement of joint state after the study period was 1.74 points (±1.66) for patients in the experimental group, while the control group exhibited a joint deterioration with 0.43 points (±0.85). Ankle joint pain under load-bearing and non-load-bearing conditions improved in the experimental group with −1.72 (±1.86) and −0.50 (±1.39) points, respectively. Conclusion: The study showed that fascial therapy is favorable for patients with hemophilic ankle arthropathy.

scholarly journals Effect of a 36-month Pharmaceutical Care Program on the Coronary Heart Disease Risk in Elderly Diabetic and Hypertensive Patients

2011 ◽  
Vol 14 (2) ◽  
pp. 249 ◽  
Author(s):  
Paulo Roque Obreli Neto ◽  
Srecko Marusic ◽  
Divaldo Pereira De Lyra Júnior ◽  
Diogo Pilger ◽  
Joice Mara Cruciol-Souza ◽  
...  
Keyword(s):  
Coronary Heart Disease ◽  
Heart Disease ◽  
Pharmaceutical Care ◽  
Coronary Heart Disease Risk ◽  
Disease Risk ◽  
Intervention Group ◽  
Care Program ◽  
Control Group ◽  
Hypertensive Patients ◽  
Heart Disease Risk

Purpose. To examine the effect of a pharmaceutical care program on the coronary heart disease risk in elderly diabetic and hypertensive patients. Methods. A total of 200 elderly (> 60 years) diabetic and/or hypertensive patients were recruited into a randomized, controlled, prospective clinical trial with a 36-month follow-up, developed in a public primary health care unit in a municipality in the Brazilian State of Sao Paulo. A range of clinical measurements were evaluated at the baseline and up to 36 months afterwards. The intervention group patients received pharmaceutical care from a clinical pharmacist, whereas the control group patients received their usual care from the medical and nursing staff. The Framingham scoring method was used to estimate changes in the 10-year coronary heart disease risk scores of all the patients. Results. A total of 194 patients completed the study. Significant reductions (p < 0.05) in the mean values (baseline vs. 36 months) for the systolic blood pressure [156.7mmHg vs 133.7mmHg; p

scholarly journals Effect of a Controlled Feedback Intervention on Laboratory Test Ordering by Community Physicians

2004 ◽  
Vol 50 (2) ◽  
pp. 321-326 ◽  
Author(s):  
Peter S Bunting ◽  
Carl van Walraven
Keyword(s):  
Laboratory Test ◽  
Intervention Group ◽  
Population Based ◽  
Control Group ◽  
Relative Reduction ◽  
Reference Laboratory ◽  
Intention To Treat ◽  
General Terms ◽  
Utilization Data ◽  
Personal Approach

Abstract Background: Most studies of interventions to reduce laboratory test utilization have occurred in academic hospital settings, used historical controls, or have had short postintervention follow-up. Interventions with the greatest impact use multiple approaches, are repeated regularly, include comparisons with physician peers, and have a personal approach. We determined whether laboratory test utilization by community physicians could be reduced by a multifaceted program of education and feedback. Methods: We identified 200 physicians who ordered the largest number of common laboratory tests during 1 year in a nonhospital, commercial community (reference) laboratory. They were assigned to intervention and control groups (100 each). Intervention physicians were visited individually up to three times by laboratory representatives over a 2-year period. At each visit, educational material and the physician’s personal laboratory test utilization data were presented and discussed briefly in general terms, with the latter compared with utilization data for the physician’s peers. Overall test utilization rates 1 year before, during, and 2 years after the intervention were measured using population-based databases. Time-series analysis was used to determine the effect of the intervention on laboratory test utilization. Results: The two groups began with similar test utilization: control group, 4.06 × 106 tests in 1.48 × 106 visits (2.73 tests/visit); intervention group, 3.90 × 106 tests in 1.41 × 106 visits (2.77 tests/visit). During the 2-year intervention, intention-to-treat analysis showed that utilization decreased significantly in the intervention group compared with the controls [relative reduction of 7.9% (P &lt;0.0001); absolute reduction of 0.22 tests/visit (95% confidence interval, 0.20–0.24)]. This difference persisted until the end of study observation, or more than 2 years after the intervention ended. Conclusion: A multifaceted education and feedback strategy can significantly and persistently decrease laboratory utilization by practicing community physicians.

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