scholarly journals Effectiveness of An Impedance Cardiography Guided Treatment Strategy to Improve Blood Pressure Control in A Real-World Setting: Results from A Pilot Pragmatic Clinical Trial

2021 ◽  
Author(s):  
Luyan Wang ◽  
Yuan Lu ◽  
Hongyi Wang ◽  
Jianlei Gu ◽  
Zheng J. Ma ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Real World ◽  
Treatment Strategy ◽  
Standard Care ◽  
Impedance Cardiography ◽  
Care Group ◽  
Standard Care Group ◽  
Peking University ◽  
The Mean

ABSTRACTBackgroundHypertension is a hemodynamic-related disorder characterized by abnormalities of the cardiac output (CO) and/or systemic vascular resistance (SVR). We hypothesized that selecting antihypertensive therapy based on patients’ hemodynamic profile could improve blood pressure (BP) control more effectively than standard care in hypertensive patients in real-world clinical practice.MethodsWe conducted a pilot single-center, pragmatic randomized trial involving adults with uncontrolled hypertension who sought outpatient care at a hypertension clinic of the Peking University People’s Hospital, the largest teaching hospital of Peking University, in Beijing China, between December 2018 and December 2019. Participants were randomly assigned to the standard care group or the hemodynamic group in a 1:1 ratio. Impedance cardiography (ICG) was performed with all participants to measure hemodynamic parameters. Only physicians in the hemodynamic group were provided with patients’ ICG findings and a computerized clinical decision support of recommended treatment choices based on patients’ hemodynamic profiles. The primary outcomes were the changes in systolic BP (SBP) and diastolic BP (DBP) levels at the follow-up visit 4-12 weeks after baseline. Secondary outcomes included achievement of BP goal of <140/ 90 mmHg and the changes in BP by baseline BP, age, sex, and BMI.ResultsA total 102 adults (mean age was 54±14 years; 41% were women) completed the study. The mean baseline SBP was 150.9 (±11.5) mmHg and mean baseline DBP was 91.1 (±11.3) mmHg. At the follow-up visit, the mean SBP and DBP decreased by 19.9 and 11.3 mmHg in the hemodynamic group, as compared with 12.0 and 4.9 mmHg in the standard care group (P value for difference between groups <0.001 for both SBP and DBP). The proportion of patients achieving BP goal of <140/ 90 mmHg in the hemodynamic group was 67%, as compared with 41% in the standard care group (P=0.017). The hemodynamic group had a larger effect on BP reduction consistently across subgroups by age, sex, BMI, and baseline BP.ConclusionsAn ICG-guided treatment strategy led to greater reductions in BP levels than were observed with standard care in a real-world population of outpatients with hypertension. There is a need for further validation of this strategy for improving blood pressure treatment selection. (Funded by internal research grant from the Peking University People’s Hospital; ClinicalTrials.gov number: NCT04715698.)

scholarly journals Effectiveness of an impedance cardiography guided treatment strategy to improve blood pressure control in a real-world setting: results from a pragmatic clinical trial

Open Heart ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. e001719
Author(s):  
Yuan Lu ◽  
Luyan Wang ◽  
Hongyi Wang ◽  
Jianlei Gu ◽  
Zheng J Ma ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Real World ◽  
Treatment Strategy ◽  
Standard Care ◽  
Impedance Cardiography ◽  
Care Group ◽  
Hypertension Clinic ◽  
Peking University ◽  
The Mean

ObjectiveTo test the effectiveness of an impedance cardiography (ICG) guided treatment strategy on improving blood pressure (BP) control in real-world clinical practice.DesignA single-centre, pragmatic randomised trial.SettingA hypertension clinic of the Peking University People’s Hospital in Beijing, China.ParticipantsAdults who sought outpatient care for hypertension in the hypertension clinic at the Peking University People’s Hospital between June and December 2019.InterventionsA computerised clinical decision support of recommending treatment choices to providers based on patients’ haemodynamic profiles measured by ICG.Main outcome measuresChanges in systolic BP (SBP) and diastolic BP (DBP) levels at the follow-up visit 4–12 weeks after baseline. Secondary outcomes included achievement of BP goal of <140/90 mm Hg and the changes in BP by baseline BP, age, sex and body mass index (BMI).ResultsA total of 102 adults (mean age was 54±14 years; 41% were women) completed the study. The mean baseline SBP was 150.9 (SD of 11.5) mm Hg and mean baseline DBP was 91.1 (11.3) mm Hg. At the follow-up visit, the mean SBP and DBP decreased by 19.9 and 11.3 mm Hg in the haemodynamic group, as compared with 12.0 and 4.9 mm Hg in the standard care group (p value for difference between groups <0.001). The proportion of patients achieving BP goal of <140/90 mm Hg in the haemodynamic group was 67%, as compared with 41% in the standard care group (p=0.017). The haemodynamic group had a larger effect on BP reduction consistently across subgroups by age, sex, BMI and baseline BP.ConclusionsAn ICG-guided treatment strategy led to greater reductions in BP levels than were observed with standard care in a real-world population of outpatients with hypertension. There is a need for further validation of this strategy for improving blood pressure treatment selection.Trial registration numberNCT04715698.

scholarly journals Cost-effectiveness of soluble beta-glucan gel in hard-to-heal wounds: an evaluation

2019 ◽  
Vol 28 (7) ◽  
pp. 454-460
Author(s):  
Fredrik Elg ◽  
John Posnett ◽  
Sharon Hunt
Keyword(s):  
Cost Effectiveness ◽  
Standard Care ◽  
Healing Rate ◽  
Care Group ◽  
Nursing Time ◽  
Standard Care Group ◽  
Short Term ◽  
Beta Glucan ◽  
Care Protocol ◽  
The Mean

Objective: To evaluate the cost-effectiveness of a soluble beta-glucan-containing gel as short-term adjunct therapy in the treatment of hard-to-heal wounds in a UK community health-care setting. Methods: A comparative clinical evaluation involving consecutive patients treated for up to eight weeks with a beta-glucan-containing gel as adjunct to standard care. This was compared with consecutive patients as retrospective controls, and using the same standard care protocol from a year previously. The inclusion criteria was wounds that were slow-healing or stalled (<40% healing in four weeks). Results: A total of 300 patients took part. Complete follow-up at 24 weeks was available for 144 patients in the beta-glucan group, and 136 patients in the standard care group. At 24 weeks, the beta-glucan group had a 96% healing rate compared with 75% in the standard care group (p<0.001). The improvement in healing was associated with a reduction in the mean number of weeks of treatment per patient (7.2 and 10.7 for beta-glucan and standard care, respectively), and a reduction in the mean cost of treatment (£576 versus £685 for beta-glucan and standard care, respectively). Treatment costs included nursing time, prescription medications and dressings. In a subset of ulcer wounds (50% of the full sample), at 24 weeks the beta-glucan group had a 92% healing rate compared with 46% in the standard care group (p<0.001). Mean weeks of treatment were 10.4 versus 17.6, leading to a reduction in treatment cost of £388 per patient (£1227 versus £839) over 24 weeks. Conclusion: The results of this evaluation suggest that short-term use of the beta-glucan gel as an adjunct to standard care on slow-healing wounds can shorten healing times and reduce NHS costs.

scholarly journals Post-discharge after surgery Virtual Care with Remote Automated Monitoring-1 (PVC-RAM-1) technology versus standard care: randomised controlled trial

BMJ ◽  
2021 ◽  
pp. n2209
Author(s):  
Michael H McGillion ◽  
Joel Parlow ◽  
Flavia K Borges ◽  
Maura Marcucci ◽  
Michael Jacka ◽  
...  
Keyword(s):  
Standard Care ◽  
Elective Surgery ◽  
Controlled Trial ◽  
Absolute Difference ◽  
Care Group ◽  
Standard Care Group ◽  
Virtual Care ◽  
Randomised Controlled ◽  
At Home

Abstract Objective To determine if virtual care with remote automated monitoring (RAM) technology versus standard care increases days alive at home among adults discharged after non-elective surgery during the covid-19 pandemic. Design Multicentre randomised controlled trial. Setting 8 acute care hospitals in Canada. Participants 905 adults (≥40 years) who resided in areas with mobile phone coverage and were to be discharged from hospital after non-elective surgery were randomised either to virtual care and RAM (n=451) or to standard care (n=454). 903 participants (99.8%) completed the 31 day follow-up. Intervention Participants in the experimental group received a tablet computer and RAM technology that measured blood pressure, heart rate, respiratory rate, oxygen saturation, temperature, and body weight. For 30 days the participants took daily biophysical measurements and photographs of their wound and interacted with nurses virtually. Participants in the standard care group received post-hospital discharge management according to the centre’s usual care. Patients, healthcare providers, and data collectors were aware of patients’ group allocations. Outcome adjudicators were blinded to group allocation. Main outcome measures The primary outcome was days alive at home during 31 days of follow-up. The 12 secondary outcomes included acute hospital care, detection and correction of drug errors, and pain at 7, 15, and 30 days after randomisation. Results All 905 participants (mean age 63.1 years) were analysed in the groups to which they were randomised. Days alive at home during 31 days of follow-up were 29.7 in the virtual care group and 29.5 in the standard care group: relative risk 1.01 (95% confidence interval 0.99 to 1.02); absolute difference 0.2% (95% confidence interval −0.5% to 0.9%). 99 participants (22.0%) in the virtual care group and 124 (27.3%) in the standard care group required acute hospital care: relative risk 0.80 (0.64 to 1.01); absolute difference 5.3% (−0.3% to 10.9%). More participants in the virtual care group than standard care group had a drug error detected (134 (29.7%) v 25 (5.5%); absolute difference 24.2%, 19.5% to 28.9%) and a drug error corrected (absolute difference 24.4%, 19.9% to 28.9%). Fewer participants in the virtual care group than standard care group reported pain at 7, 15, and 30 days after randomisation: absolute differences 13.9% (7.4% to 20.4%), 11.9% (5.1% to 18.7%), and 9.6% (2.9% to 16.3%), respectively. Beneficial effects proved substantially larger in centres with a higher rate of care escalation. Conclusion Virtual care with RAM shows promise in improving outcomes important to patients and to optimal health system function. Trial registration ClinicalTrials.gov NCT04344665 .

scholarly journals The influence of common polygenic risk and gene sets on social skills group training response in autism spectrum disorder

2020 ◽  
Vol 5 (1) ◽  
Author(s):  
Danyang Li ◽  
Nora Choque-Olsson ◽  
Hong Jiao ◽  
Nina Norgren ◽  
Ulf Jonsson ◽  
...  
Keyword(s):  
Standard Care ◽  
Autism Spectrum ◽  
Care Group ◽  
Group Training ◽  
Common Variants ◽  
Standard Care Group ◽  
Gene Sets ◽  
Social Skills Group ◽  
Skills Group

Abstract Social skills group training (SSGT) is a frequently used behavioral intervention in autism spectrum disorder (ASD), but the effects are moderate and heterogeneous. Here, we analyzed the effect of polygenic risk score (PRS) and common variants in gene sets on the intervention outcome. Participants from the largest randomized clinical trial of SSGT in ASD to date were selected (N = 188, 99 from SSGT, 89 from standard care) to calculate association between the outcomes in the SSGT trial and PRSs for ASD, attention-deficit hyperactivity disorder (ADHD), and educational attainment. In addition, specific gene sets were selected to evaluate their role on intervention outcomes. Among all participants in the trial, higher PRS for ADHD was associated with significant improvement in the outcome measure, the parental-rated Social Responsiveness Scale. The significant association was due to better outcomes in the standard care group for individuals with higher PRS for ADHD (post-intervention: β = −4.747, P = 0.0129; follow-up: β = −5.309, P = 0.0083). However, when contrasting the SSGT and standard care group, an inferior outcome in the SSGT group was associated with higher ADHD PRS at follow-up (β = 6.67, P = 0.016). Five gene sets within the synaptic category showed a nominal association with reduced response to interventions. We provide preliminary evidence that genetic liability calculated from common variants could influence the intervention outcomes. In the future, larger cohorts should be used to investigate how genetic contribution affects individual response to ASD interventions.

The Effects of Mean of Visit-to-Visit Blood Pressure on Incident Brain Vascular Lesions and Functional-Cognitive Decline

2021 ◽  
pp. 1-12
Author(s):  
Bibek Gyanwali ◽  
Celestine Xue Ting Cai ◽  
Christopher Chen ◽  
Henri Vrooman ◽  
Chuen Seng Tan ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Cognitive Decline ◽  
Hippocampal Volume ◽  
Intracranial Stenosis ◽  
Vascular Lesions ◽  
Linear Regression Models ◽  
Volume Functional ◽  
Mri Scans ◽  
The Mean

Background: Cerebrovascular disease (CeVD) is an underlying cause of cognitive impairment and dementia. Hypertension is a known risk factor of CeVD, but the effects of mean of visit-to-visit blood pressure (BP) on incident CeVD and functional-cognitive decline remains unclear. Objective: To determine the association between mean of visit-to-visit BP with the incidence and progression of CeVD [white matter hyperintensities (WMH), infarcts (cortical infarcts and lacunes), cerebral microbleeds (CMBs), intracranial stenosis, and hippocampal volume] as well as functional-cognitive decline over 2 years of follow-up. Methods: 373 patients from a memory-clinic underwent BP measurements at baseline, year 1, and year 2. The mean of visit-to-visit systolic BP, diastolic BP, pulse pressure, and mean arterial pressure were calculated. Baseline and year 2 MRI scans were graded for WMH, infarcts, CMBs, intracranial stenosis, and hippocampal volume. Functional-cognitive decline was assessed using locally validated protocol. Logistic and linear regression models with odds ratios, mean difference, and 95%confidence interval were constructed to analyze associations of visit-to-visit BP on CeVD incidence and progression as well as functional-cognitive decline. Results: Higher mean of visit-to-visit diastolic BP was associated with WMH progression. Higher tertiles of diastolic BP was associated with WMH progression and incident CMBs. There was no association between mean of visit-to-visit BP measures with incident cerebral infarcts, intracranial stenosis, change in hippocampal volume, and functional-cognitive decline. Conclusion: These findings suggest the possibility of hypertension-related vascular brain damage. Careful monitoring and management of BP in elderly patients is essential to reduce the incidence and progression of CeVD.

scholarly journals A longitudinal analysis of the progression from normal blood pressure to stage 2 hypertension: A 12-year Korean cohort

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Eun Sun Yu ◽  
Kwan Hong ◽  
Byung Chul Chun
Keyword(s):  
Blood Pressure ◽  
Health Insurance ◽  
American Heart Association ◽  
American Heart ◽  
Heart Association ◽  
Normal Blood ◽  
Normal Blood Pressure ◽  
The Mean ◽  
Stage 1

Abstract Background The study aimed to estimate the incidence of and period of progression to stage 2 hypertension from normal blood pressure. Methods We selected a total of 21,172 normotensive individuals between 2003 and 2004 from the National Health Insurance Service-Health Screening and followed them up until 2015. The criteria for blood pressure were based on the American College of Cardiology/American Heart Association 2017 guideline (normal BP: SBP < 120 and DBP < 80 mmHg, elevated BP: SBP 120–129 and DBP < 80 mmHg, stage 1 hypertension: SBP 130–139 or DBP 80–89 mmHg, stage 2 hypertension: SBP ≥140 or DBP ≥ 90 mmHg). We classified the participants into four courses (Course A: normal BP → elevated BP → stage 1 hypertension→ stage 2 hypertension, Course B: normal BP → elevated BP → stage 2 hypertension, Course C: normal BP → stage 1 hypertension → stage 2 hypertension, Course D: normal BP → stage 2 hypertension) according to their progression from normal blood pressure to stage 2 hypertension. Results During the median 12.23 years of follow-up period, 52.8% (n= 11,168) and 23.6% (n=5004) of the participants had stage 1 and stage 2 hypertension, respectively. In particular, over 60 years old had a 2.8-fold higher incidence of stage 2 hypertension than 40–49 years old. After the follow-up period, 77.5% (n=3879) of participants with stage 2 hypertension were found to be course C (n= 2378) and D (n=1501). After the follow-up period, 77.5% (n=3879) of participants with stage 2 hypertension were found to be course C (n= 2378) and D (n=1501). The mean years of progression from normal blood pressure to stage 2 hypertension were 8.7±2.6 years (course A), 6.1±2.9 years (course B), 7.5±2.8 years (course C) and 3.2±2.0 years, respectively. Conclusions This study found that the incidence of hypertension is associated with the progression at each stage. We suggest that the strategies necessary to prevent progression to stage 2 hypertension need to be set differently for each target course.

scholarly journals Real-world effectiveness of app-based treatment for urinary incontinence: a cohort study

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e040819
Author(s):  
Pontus Rygh ◽  
Ina Asklund ◽  
Eva Samuelsson
Keyword(s):  
Urinary Incontinence ◽  
Cohort Study ◽  
Real World ◽  
Short Form ◽  
Pelvic Floor Muscle ◽  
Controlled Trial ◽  
Healthcare Services ◽  
International Consultation ◽  
The Mean

ObjectivesThe efficacy of app-based treatment for stress urinary incontinence (SUI) has been demonstrated in a randomised controlled trial (RCT). In this study, we investigate the user characteristics and the effectiveness of the same app when freely available, and compare these results with the RCT.DesignProspective cohort study.ParticipantsDuring a 17-month period, 24 602 non-pregnant, non-postpartum women older than 18 years downloaded the app and responded anonymously to a questionnaire. Of these, 2672 (11%) responded to the 3-month follow-up.InterventionThree months’ use of the app Tät, containing information, a pelvic floor muscle training programme and lifestyle advice.Main outcome measuresChange in symptom severity (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)) and subjective improvement (Patient Global Impression of Improvement (PGI-I)).ResultsOf the respondents, 88% lived in Sweden and 75% (18 384/24 602) were incontinent with a mean age of 45.5 (SD 14.1) years. The UI types, based on symptoms, were SUI (53%), urgency UI (12%), mixed UI (31%) and undefined (4%). The mean ICIQ-UI SF score was 8.2 (SD 4.0) at baseline. The mean ICIQ-UI SF score reduction at follow-up was 1.31 (95% CI: 1.19 to 1.44) with a larger reduction in those with more severe incontinence at baseline (severe/very severe 3.23 (95% CI: 2.85 to 3.61), moderate 1.41 (95% CI: 1.24 to 1.59) and slight 0.24 (95% CI 0.06 to 0.42). When the results were weighted to match the distribution of severity in the RCT, the ICIQ-UI SF score reduction was 2.2 compared with 3.9 in the RCT. Regarding PGI-I, 65% experienced improvement compared with 92% in the RCT.ConclusionsThe app Tät was effective for self-management of UI even in the real world. Although the reduction in incontinence symptoms was less than in the RCT, two-thirds of the users improved. App-based treatment reaches many women without requiring resources from ordinary healthcare services.

scholarly journals One-year intensive lifestyle intervention and improvements in health-related quality of life and mental health in persons with type 2 diabetes: a secondary analysis of the U-TURN randomized controlled trial

2021 ◽  
Vol 9 (1) ◽  
pp. e001840
Author(s):  
Christopher Scott MacDonald ◽  
Sabrina M Nielsen ◽  
Jakob Bjørner ◽  
Mette Y Johansen ◽  
Robin Christensen ◽  
...  
Keyword(s):  
Lifestyle Intervention ◽  
Standard Care ◽  
Controlled Trial ◽  
Care Group ◽  
Standard Care Group ◽  
Intensive Lifestyle Intervention ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

IntroductionThe effects of lifestyle interventions in persons with type 2 diabetes (T2D) on health-related quality of life (HRQoL) and subjective well-being are ambiguous, and no studies have explored the effect of exercise interventions that meet or exceed current recommended exercise levels. We investigated whether a 1-year intensive lifestyle intervention is superior in improving HRQoL compared with standard care in T2D persons.Research design and methodsWe performed secondary analyses of a previously conducted randomized controlled trial (April 2015 to August 2016). Persons with non-insulin-dependent T2D (duration ≤10 years) were randomized to 1-year supervised exercise and individualized dietary counseling (ie, ‘U-TURN’), or standard care. The primary HRQoL outcome was change in the 36-item Short Form Health Survey (SF-36) physical component score (PCS) from baseline to 12 months of follow-up, and a key secondary outcome was changes in the SF-36 mental component score (MCS).ResultsWe included 98 participants (U-TURN group=64, standard care group=34) with a mean age of 54.6 years (SD 8.9). Between-group analyses at 12-month follow-up showed SF-36 PCS change of 0.8 (95% CI −0.7 to 2.3) in the U-TURN group and deterioration of 2.4 (95% CI −4.6 to −0.1) in the standard care group (difference of 3.2, 95% CI 0.5 to 5.9, p=0.02) while no changes were detected in SF-36 MCS. At 12 months, 19 participants (30%) in the U-TURN group and 6 participants (18%) in the standard care group achieved clinically significant improvement in SF-36 PCS score (adjusted risk ratio 2.6, 95% CI 1.0 to 4.5 corresponding to number needed to treat of 4, 95% CI 1.6 to infinite).ConclusionIn persons with T2D diagnosed for less than 10 years, intensive lifestyle intervention improved the physical component of HRQoL, but not the mental component of HRQoL after 1 year, compared with standard care.Trial registration numberNCT02417012.

scholarly journals Real-World Clinical Outcomes Associated with Canagliflozin in Patients with Type 2 Diabetes Mellitus in Spain: The Real-Wecan Study

2020 ◽  
Vol 9 (7) ◽  
pp. 2275
Author(s):  
Juan J. Gorgojo-Martínez ◽  
Manuel A. Gargallo-Fernández ◽  
Alba Galdón Sanz-Pastor ◽  
Teresa Antón-Bravo ◽  
Miguel Brito-Sanfiel ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Real World ◽  
Primary Outcome ◽  
Baseline Hba1c ◽  
Real World Setting ◽  
Antihyperglycemic Therapy ◽  
The Mean ◽  
Hba1c Levels

The aims of this multicentric retrospective study were to assess in a real-world setting the effectiveness and safety of canagliflozin 100 mg/d (CANA100) as an add-on to the background antihyperglycemic therapy, and to evaluate the intensification of prior sodium–glucose co-transporter type 2 inhibitor (SGLT-2i) therapy by switching to canagliflozin 300 mg/d (CANA300) in patients with T2DM. One cohort of SGLT2i-naïve patients with T2DM who were initiated on CANA100 and a second cohort of patients with prior background SGLT-2i therapy who switched to CANA300 were included in the study. The primary outcome of the study was the mean change in HbA1c over the follow-up time. In total, 583 patients were included—279 in the cohort of CANA100 (HbA1c 8.05%, weight 94.9 kg) and 304 in the cohort of CANA300 (HbA1c 7.51%, weight 92.0 kg). Median follow-up periods in both cohorts were 9.1 and 15.4 months respectively. CANA100 was associated to significant reductions in HbA1c (−0.90%) and weight (−4.1 kg) at the end of the follow-up. In those patients with baseline HbA1c > 8% (mean 9.25%), CANA100 lowered HbA1c levels by 1.51%. In the second cohort, patients switching to CANA300 experienced a significant decrease in HbA1c (−0.35%) and weight (−2.1 kg). In those patients with baseline HbA1c > 8% (mean 8.94%), CANA300 lowered HbA1c levels by 1.12%. There were significant improvements in blood pressure in both cohorts. No unexpected adverse events were reported. In summary, CANA100 (as an add-on therapy) and CANA300 (switching from prior SGLT-2i therapy) significantly improved several cardiometabolic parameters in patients with T2DM.

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