A Critical Analysis of the Specific Pharmacist Interventions and Risk Assessments During the 12-Month TRANSAFE Rx Randomized Controlled Trial

2021 ◽  
pp. 106002802110447
Author(s):  
Haley M. Gonzales ◽  
James N. Fleming ◽  
Mulugeta Gebregziabher ◽  
Maria Aurora Posadas Salas ◽  
John W. McGillicuddy ◽  
...  
Keyword(s):  
High Risk ◽  
Medication Reconciliation ◽  
Controlled Trial ◽  
Therapy Monitoring ◽  
Pharmacist Intervention ◽  
Risk Levels ◽  
Medication Therapy ◽  
Risk Patients ◽  
The Impact ◽  
Medication Changes

Background Medication safety issues have detrimental implications on long-term outcomes in the high-risk kidney transplant (KTX) population. Medication errors, adverse drug events, and medication nonadherence are important and modifiable mechanisms of graft loss. Objective To describe the frequency and types of interventions made during a pharmacist-led, mobile health–based intervention in KTX recipients and the impact on patient risk levels. Methods This was a secondary analysis of data collected during a 12-month, parallel-arm, 1:1 randomized clinical controlled trial including 136 KTX recipients. Participants were randomized to receive either usual care or supplemental, pharmacist-driven medication therapy monitoring and management using a smartphone-enabled app integrated with telemonitoring of blood pressure and glucose (when applicable) and risk-based televisits. The primary outcome was pharmacist intervention type. Secondary outcomes included frequency of interventions and changes in risk levels. Results A total of 68 patients were randomized to the intervention and included in this analysis. The mean age at baseline was 50.2 years; 51.5% of participants were male, and 58.8% were black. Primary pharmacist intervention types were medication reconciliation and patient education, followed by medication changes. Medication reconciliation remained high throughout the study period, whereas education and medication changes trended downward. From baseline to month 12, we observed an approximately 15% decrease in high-risk patients and a corresponding 15% increase in medium- or low-risk patients. Conclusion and Relevance A pharmacist-led mHealth intervention may enhance opportunities for pharmacological and nonpharmacological interventions and mitigate risk levels in KTX recipients.

scholarly journals Effectiveness of Yoga Lifestyle on Lipid Metabolism in a Vulnerable Population—A Community Based Multicenter Randomized Controlled Trial

Medicines ◽  
2021 ◽  
Vol 8 (7) ◽  
pp. 37
Author(s):  
Raghuram Nagarathna ◽  
Saurabh Kumar ◽  
Akshay Anand ◽  
Ishwara N. Acharya ◽  
Amit Kumar Singh ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
High Risk ◽  
Controlled Trial ◽  
Density Lipoprotein ◽  
Lipid Profiles ◽  
Community Based ◽  
Randomized Controlled ◽  
Rural And Urban ◽  
Yoga Group ◽  
The Impact

Background: Dyslipidemia poses a high risk for cardiovascular disease and stroke in Type 2 diabetes (T2DM). There are no studies on the impact of a validated integrated yoga lifestyle protocol on lipid profiles in a high-risk diabetes population. Methods: Here, we report the results of lipid profile values of 11,254 (yoga 5932 and control 5322) adults (20–70 years) of both genders with high risk (≥60 on Indian diabetes risk score) for diabetes from a nationwide rural and urban community-based two group (yoga and conventional management) cluster randomized controlled trial. The yoga group practiced a validated integrated yoga lifestyle protocol (DYP) in nine day camps followed by daily one-hour practice. Biochemical profiling included glycated hemoglobin and lipid profiles before and after three months. Results: There was a significant difference between groups (p < 0.001 ANCOVA) with improved serum total cholesterol, triglycerides, low-density lipoprotein, and high-density lipoprotein in the yoga group compared to the control group. Further, the regulatory effect of yoga was noted with a significant decrease or increase in those with high or low values of lipids, respectively, with marginal or no change in those within the normal range. Conclusion: Yoga lifestyle improves and regulates (lowered if high, increased if low) the blood lipid levels in both genders of prediabetic and diabetic individuals in both rural and urban Indian communities.

Albumin Utilization in Spontaneous Bacterial Peritonitis

2021 ◽  
pp. 089719002199700
Author(s):  
Alex M. Ebied ◽  
Thakul Rattanasuwan ◽  
Yiqing Chen ◽  
Adonice P. Khoury
Keyword(s):  
High Risk ◽  
Spontaneous Bacterial Peritonitis ◽  
Total Bilirubin ◽  
Kidney Injury ◽  
Inclusion Criteria ◽  
Dosing Regimen ◽  
Bacterial Peritonitis ◽  
Risk Patients ◽  
The Impact ◽  
Order Set

Background: Albumin has been shown to decrease the incidence of mortality and acute kidney injury (AKI) in patients with spontaneous bacterial peritonitis (SBP). Albumin administration in SBP is recommended within 6 hours of diagnosis and for reserved use in high-risk patients with the following baseline laboratory tests: serum creatinine >1 mg/dL, blood urea nitrogen >30 mg/dL or total bilirubin >4 mg/dL. Objective: We aimed to assess the impact of an albumin order set restricted to high-risk SBP. Methods: A retrospective cohort study was conducted between Jan 1, 2013 to Feb 28, 2018. The albumin order set was implemented on Sep 20, 2016. Patients were included if they were diagnosed with SBP and had an ascitic fluid polymorphonuclear count ≥ 250 cells/mm3. Results: Out of a total of 137 patients reviewed, 88 met the inclusion criteria. The incidence of AKI in the pre-order set and post-order set were 63.93% and 33.33% (p = 0.01), respectively. The incidence of mortality in the pre-order set and post-order set were 36.07% and 7.41% (p = 0.005), respectively. The percentage of patients administered albumin within 6 hours were 24.59% to 40.74% (p = 0.14) in the pre-order set and post-order set, respectively. The percentage of patients who received the recommended albumin dosing regimen ordered was 42.62% vs 96.30% (p < 0.001), in the pre-order set and post-order set, respectively. Conclusion: The albumin order set restricted to high-risk SBP patients significantly reduced the incidence of AKI and mortality, and improved the appropriateness of albumin regimen ordered.

Early Physical Therapy Effects on the High-Risk Infant: A Randomized Controlled Trial

PEDIATRICS ◽  
1986 ◽  
Vol 78 (2) ◽  
pp. 216-224
Author(s):  
Martha C. Piper ◽  
V. Ildiko Kunos ◽  
Diana M. Willis ◽  
Barbara L. Mazer ◽  
Maria Ramsay ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Physical Therapy ◽  
High Risk ◽  
Motor Development ◽  
Controlled Trial ◽  
Physical Growth ◽  
Control Group ◽  
Randomized Controlled ◽  
Early Physical Therapy ◽  
The Impact

A prospective, randomized, controlled trial was conducted to assess the effects of early physical therapy on infants at risk for neurologic sequelae and to evaluate the impact of such early treatment on the prevention or minimization of future handicaps. A cohort of 134 infants who had received care in two Montreal inborn neonatal intensive care units was identified prospectively. Infants were stratified according to prognosis and birth weight and were randomly assigned to either an experimental or control group. Babies assigned to the experimental group received early physical therapy, whereas those allocated to the control group received conventional follow-up care. Outcome measures were administered by independent evaluators at 12 months and included measures of neurologic status, motor and overall development, and physical growth. No statistically significant differences on any of the measured outcomes at 12 months were found between the experimental and control groups. Infants weighing less than 750 g at birth, regardless of group assignment, consistently demonstrated significant delays in their growth and development when compared with their heavier peers. The early physical therapy program investigated in this study was not efficacious in altering the pattern of motor development in those high-risk infants participating in the trial.

Impact of a Clinical Pharmacy Admission Medication Reconciliation Program on Medication Errors in “High-Risk” Patients

2013 ◽  
Vol 47 (12) ◽  
pp. 1599-1610 ◽  
Author(s):  
Mitchell S. Buckley ◽  
Lisa M. Harinstein ◽  
Kimberly B. Clark ◽  
Pamela L. Smithburger ◽  
Doug J. Eckhardt ◽  
...  
Keyword(s):  
High Risk ◽  
Medication Errors ◽  
Clinical Pharmacy ◽  
Medication Reconciliation ◽  
High Risk Patients ◽  
Risk Patients

scholarly journals Impact of Different Modules of 21-Gene Assay in Early Breast Cancer Patients

2021 ◽  
Vol 12 ◽  
Author(s):  
Mengdi Chen ◽  
Deyue Liu ◽  
Weilin Chen ◽  
Weiguo Chen ◽  
Kunwei Shen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Cancer Patients ◽  
Low Risk ◽  
Breast Cancer Patients ◽  
Younger Patients ◽  
Gene Assay ◽  
Risk Patients ◽  
Gene Modules ◽  
The Impact

BackgroundThe 21-gene assay recurrence score (RS) provides additional information on recurrence risk of breast cancer patients and prediction of chemotherapy benefit. Previous studies that examined the contribution of the individual genes and gene modules of RS were conducted mostly in postmenopausal patients. We aimed to evaluate the gene modules of RS in patients of different ages.MethodsA total of 1,078 estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer patients diagnosed between January 2009 and March 2017 from Shanghai Jiao Tong University Breast Cancer Data Base were included. All patients were divided into three subgroups: Group A, ≤40 years and premenopausal (n = 97); Group B, &gt;40 years and premenopausal (n = 284); Group C, postmenopausal (n = 697). The estrogen, proliferation, invasion, and HER2 module scores from RS were used to characterize the respective molecular features. Spearman correlation and analysis of the variance tests were conducted for RS and its constituent modules.ResultsIn patients &gt;40 years, RS had a strong negative correlation with its estrogen module (ρ = −0.76 and −0.79 in Groups B and C) and a weak positive correlation with its invasion module (ρ = 0.29 and 0.25 in Groups B and C). The proliferation module mostly contributed to the variance in young patients (37.3%) while the ER module contributed most in old patients (54.1% and 53.4% in Groups B and C). In the genetic high-risk (RS &gt;25) group, the proliferation module was the leading driver in all patients (ρ = 0.38, 0.53, and 0.52 in Groups A, B, and C) while the estrogen module had a weaker correlation with RS. The impact of ER module on RS was stronger in clinical low-risk patients while the effect of the proliferation module was stronger in clinical high-risk patients. The association between the RS and estrogen module was weaker among younger patients, especially in genetic low-risk patients.ConclusionsRS was primarily driven by the estrogen module regardless of age, but the proliferation module had a stronger impact on RS in younger patients. The impact of modules varied in patients with different genetic and clinical risks.

scholarly journals The impact of the incorporation of a feasible postoperative mortality model at the Post-Anaesthestic Care Unit (PACU) on postoperative clinical deterioration: A pragmatic trial with 5,353 patients

PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0257941
Author(s):  
Claudia de Souza Gutierrez ◽  
Katia Bottega ◽  
Stela Maris de Jezus Castro ◽  
Gabriela Leal Gravina ◽  
Eduardo Kohls Toralles ◽  
...  
Keyword(s):  
Quality Improvement ◽  
High Risk ◽  
Clinical Deterioration ◽  
Surgical Patients ◽  
Predictive Tool ◽  
Postoperative Death ◽  
High Risk Patients ◽  
Death Probability ◽  
Risk Patients ◽  
The Impact

Background Practical use of risk predictive tools and the assessment of their impact on outcome reduction is still a challenge. This pragmatic study of quality improvement (QI) describes the preoperative adoption of a customised postoperative death probability model (SAMPE model) and the evaluation of the impact of a Postoperative Anaesthetic Care Unit (PACU) pathway on the clinical deterioration of high-risk surgical patients. Methods A prospective cohort of 2,533 surgical patients compared with 2,820 historical controls after the adoption of a quality improvement (QI) intervention. We carried out quick postoperative high-risk pathways at PACU when the probability of postoperative death exceeded 5%. As outcome measures, we used the number of rapid response team (RRT) calls within 7 and 30 postoperative days, in-hospital mortality, and non-planned Intensive Care Unit (ICU) admission. Results Not only did the QI succeed in the implementation of a customised risk stratification model, but it also diminished the postoperative deterioration evaluated by RRT calls on very high-risk patients within 30 postoperative days (from 23% before to 14% after the intervention, p = 0.05). We achieved no survival benefits or reduction of non-planned ICU. The small group of high-risk patients (13% of the total) accounted for the highest proportion of RRT calls and postoperative death. Conclusion Employing a risk predictive tool to guide immediate postoperative care may influence postoperative deterioration. It encouraged the design of pragmatic trials focused on feasible, low-technology, and long-term interventions that can be adapted to diverse health systems, especially those that demand more accurate decision making and ask for full engagement in the control of postoperative morbi-mortality.

Endometrial Cancer Lymphadenectomy Trial (ECLAT) (pelvic and para-aortic lymphadenectomy in patients with stage I or II endometrial cancer with high risk of recurrence; AGO-OP.6)

2021 ◽  
Vol 31 (7) ◽  
pp. 1075-1079
Author(s):  
Günter Emons ◽  
Jae-Weon Kim ◽  
Karin Weide ◽  
Nikolaus de Gregorio ◽  
Pauline Wimberger ◽  
...  
Keyword(s):  
Overall Survival ◽  
Endometrial Cancer ◽  
High Risk ◽  
Controlled Trial ◽  
Left Renal Vein ◽  
Stage I ◽  
Open Label ◽  
Risk Of Recurrence ◽  
Gynecology And Obstetrics ◽  
The Impact

BackgroundThe impact of comprehensive pelvic and para-aortic lymphadenectomy on survival in patients with stage I or II endometrial cancer with a high risk of recurrence is not reliably documented. The side effects of this procedure, including lymphedema and lymph cysts, are evident.Primary ObjectiveEvaluation of the effect of comprehensive pelvic and para-aortic lymphadenectomy in the absence of bulky nodes on 5 year overall survival of patients with endometrial cancer (International Federation of Gynecology and Obstetrics (FIGO) stages I and II) and a high risk of recurrence.Study HypothesisComprehensive pelvic and para-aortic lymphadenectomy will increase 5 year overall survival from 75% (no lymphadenectomy) to 83%, corresponding to a hazard ratio of 0.65.Trial DesignOpen label, randomized, controlled trial. In arm A, a total hysterectomy plus bilateral salpingo-oophorectomy is performed. In arm B, in addition, a systematic pelvic and para-aortic lymphadenectomy up to the level of the left renal vein is performed. For all patients, vaginal brachytherapy and adjuvant chemotherapy (carboplatin/paclitaxel) are recommended.Major Inclusion CriteriaPatients with histologically confirmed endometrial cancer stages pT1b–pT2, all histological subtypes, and pT1a endometrioid G3, serous, clear cell, or carcinosarcomas can be included when bulky nodes are absent. When hysterectomy has already been performed (eg, for presumed low risk endometrial cancer), study participation is also possible.Exclusion CriteriaPatients with pT1a, G1 or 2 of type 1 histology or uterine sarcomas (except for carcinosarcomas), endometrial cancers of FIGO stage III or IV (except for microscopic lymph node metastases) or visual extrauterine disease.Primary EndpointOverall survival calculated from the date of randomization until death.Sample Size640 patients will be enrolled in the study.Estimated Dates for Completing Accrual and Presenting ResultsAt present, 252 patients have been recruited. Based on this, accrual should be completed in 2025. Results should be presented in 2031.Trial RegistrationNCT03438474.

Sign in / Sign up

Export Citation Format

Share Document