scholarly journals Retention of knowledge and clinical competence among Ugandan mid-level health providers 1 year after intensive clinical mentorship in TB and HIV management

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Dan K. Senjovu ◽  
Sarah Naikoba ◽  
Pallen Mugabe ◽  
Damazo T. Kadengye ◽  
Carey McCarthy ◽  
...  
Keyword(s):  
Clinical Competence ◽  
Clinical Care ◽  
Institutional Review Board ◽  
Control Group ◽  
National Council ◽  
Task Sharing ◽  
Health Providers ◽  
Research Committee ◽  
Institutional Review ◽  
Clinical Mentorship

Abstract Introduction Clinical mentorship is effective in improving knowledge and competence of health providers and may be a useful task sharing approach for improving antiretroviral therapy. However, the endurance of the effect of clinical mentorship is uncertain. Methods The midlevel health providers who participated in a cluster-randomized trial of one-on-one, on-site, clinical mentorship in tuberculosis and HIV for 8 h a week, every 6 weeks over 9 months were followed to determine if the gains in knowledge and competence that occurred after the intervention were sustained 6- and 12-months post-intervention. In December 2014 and June 2015, their knowledge and clinical competence were respectively assessed using vignettes and a clinical observation tool of patient care. Multilevel mixed effects regression analysis was used to compare the differences in mean scores for knowledge and clinical competence between times 0, 1, 2, and 3 by arm. Results At the end of the intervention phase of the trial, the mean gain in knowledge scores and clinical competence scores in the intervention arm was 13.4% (95% confidence interval ([CI]: 7.2, 19.6), and 27.8% (95% CI: 21.1, 34.5) respectively, with no changes seen in the control arm. Following the end of the intervention; knowledge mean scores in the intervention arm did not significantly decrease at 6 months (0.6% [95% CI − 1.4, 2.6]) or 12 months (− 2.8% [95% CI: − 5.9, 0.3]) while scores in the control arm significantly increased at 6 months (6.6% [95% CI: 4.4, 8.9]) and 12 months (7.9% [95% CI: 5.4, 10.5]). Also, no significant decrease in clinical competence mean scores for intervention arm was seen at 6 month (2.8% [95% CI: − 1.8, 7.5] and 12 months (3.7% [95% CI: − 2.4, 9.8]) while in the control arm, a significant increase was seen at 6 months (5.8% [95% CI: 1.2, 10.3] and 12 months (11.5% [95% CI: 7.6, 15.5]). Conclusions Mentees sustained the competence and knowledge gained after the intervention for a period of one year. Although, there was an increase in knowledge in the control group over the follow-up period, MLP in the intervention arm experienced earlier and sustained gains. One-on-one clinical mentorship should be scaled-up as a task-sharing approach to improve clinical care. Trial Registration The study received ethics approvals from 3 institutions—the US Centers for Disease Control and Prevention Institutional Review Board (USA), the Institutional Review Board “JCRC’s HIV/AIDS Research Committee” IRB#1-IRB00001515 with Federal Wide Assurance number (FWA00009772) based in Kampala and the Uganda National Council of Science and Technology (Uganda) which approves all scientific protocols to be implemented in Uganda.

Knowledge and Competence Retention Among Mid-Level Health Providers After Intensive One-On-One Clinical Mentorship in TB and HIV Management

2020 ◽  
Author(s):  
Dan Kaggwa Senjovu ◽  
Sarah Naikoba ◽  
Pallen Mugabe ◽  
Damazo T. Kadengye ◽  
Carey McCarthy ◽  
...  
Keyword(s):  
Clinical Competence ◽  
Clinical Care ◽  
Institutional Review Board ◽  
Control Group ◽  
National Council ◽  
Task Sharing ◽  
Health Providers ◽  
Research Committee ◽  
Institutional Review ◽  
Clinical Mentorship

Abstract Introduction : Clinical mentorship is effective in improving knowledge and competence of health providers and may be a useful task sharing approach for improving antiretroviral therapy. However, the endurance of the effect of clinical mentorship is uncertain. Methods : The midlevel health providers who participated in a cluster-randomized trial of one-on-one, on-site, clinical mentorship in tuberculosis and HIV for 8 hours a week, every 6 weeks over 9 months were followed to determine if the gains in knowledge and competence that occurred after the intervention were sustained 6- and 12-months post-intervention. In December 2014 and June 2015, their knowledge and clinical competence were respectively assessed using vignettes and a clinical observation tool of patient care. Multilevel mixed effects regression analysis was used to compare the differences in mean scores for knowledge and clinical competence between times 0, 1, 2, and 3 by arm.Results: At the end of the intervention phase of the trial, the mean gain in knowledge scores and clinical competence scores in the intervention arm was 13.4% (95% confidence interval ([CI]: 7.2, 19.6), and 27.8% (95% CI: 21.1, 34.5) respectively, with no changes seen in the control arm. Following the end of the intervention; knowledge mean scores in the intervention arm did not significantly decrease at 6 months (0.6% [95% CI -1.4, 2.6]) or 12 months (-2.8% [95% CI: -5.9, 0.3]) while scores in the control arm significantly increased at 6 months (6.6% [95% CI: 4.4, 8.9]) and 12 months (7.9% [95% CI: 5.4, 10.5]). Also, no significant decrease in clinical competence mean scores for intervention arm was seen at 6 month (2.8% [95% CI: -1.8, 7.5] and 12 months (3.7% [95% CI: -2.4, 9.8]) while in the control arm, a significant increase was seen at 6 months (5.8% [95% CI: 1.2, 10.3] and 12 months (11.5% [95% CI: 7.6, 15.5]).Conclusions : Mentees sustained the competence and knowledge gained after the intervention for a period of one year. Although, there was an increase in knowledge in the control group over the follow-up period, MLP in the intervention arm experienced earlier and sustained gains. One-on-one clinical mentorship should be scaled-up as a task-sharing approach to improve clinical care.Trial Registration : The study received ethics approvals from 3 institutions – the US Centers for Disease Control and Prevention Institutional Review Board (USA), the Institutional Review Board “JCRC’s HIV/AIDS Research Committee” IRB#1-IRB00001515 with Federal Wide Assurance number (FWA00009772) based in Kampala and the Uganda National Council of Science and Technology (Uganda) which approves all scientific protocols to be implemented in Uganda.

scholarly journals Hypercoagulation and Hypermetabolism of Fibrinogen in Severely Burned Adults

2019 ◽  
Author(s):  
Wenjun Z Martini ◽  
John B Holcomb ◽  
Yong-Ming Yu ◽  
Steven E Wolf ◽  
Leopoldo C Cancio ◽  
...  
Keyword(s):  
Stable Isotope ◽  
Vital Signs ◽  
Institutional Review Board ◽  
Control Group ◽  
Clot Strength ◽  
Blood Samples ◽  
Respiration Rates ◽  
Institutional Review ◽  
Production And Consumption ◽  
D Dimer

Abstract This study investigated changes in plasma fibrinogen metabolism and changes in coagulation in severely burned adults. Ten patients (27 ± 3 years; 91 ± 6 kg) with 51 ± 3% TBSA were consented and enrolled into an institutional review board–approved prospective study. On the study day, stable isotope infusion of 1-13C-phenylalanine and d5-phenylalanine was performed to quantify fibrinogen production and consumption. During the infusion, vital signs were recorded and blood samples were drawn every hour. Coagulation was measured by thromboelastograph (TEG). Ten normal healthy volunteers (37 ± 7 years; 74 ± 4 kg) were included as the control group. Burned adults had elevated heart rates (120 ± 2 vs 73 ± 5 [control] beats/minute), respiration rates (23 ± 2 vs 15 ± 1 breaths/minute), plasma glucose (127 ± 10 vs 89 ± 2 mg/dl), and fibrinogen levels (613 ± 35 vs 239 ± 17 mg/dl); and decreased albumin (1.3 ± 0.2 vs 3.7 ± 0.1 g/dl) and total protein (4.4 ± 0.2 vs 6.8 ± 0.1 g/dl, all P < .05). Fibrinogen breakdown was elevated in the burn group (2.3 ± 0.4 vs. 1.0 ± 0.3 µmol/kg/minute); and fibrinogen synthesis was further enhanced in the burn group (4.4 ± 0.7 vs 0.7 ± 0.2 µmol/kg/minute, both P < .05). Clotting speed (TEG-alpha) and clot strength (TEG-MA) were increased in the burn group (62 ± 4 vs 50 ± 4°, and 76 ± 2 vs 56 ± 2 mm, respectively, both P < .05). Fibrinolysis of TEG-LY60 was accelerated in the burn group (16 ± 6 vs 3 ± 1) and so was the increase in D-dimer level in the burn group (4.5 ± 0.4 vs 1.9 ± 0.3 mg/l, both P < .05). The hypercoagulable state postburn is in part a result of increased fibrinogen synthesis, over and above increased fibrinogen breakdown.

Molecular Alterations in Pulmonary Adenocarcinoma of African Americans

2019 ◽  
Vol 152 (2) ◽  
pp. 237-242
Author(s):  
Erika F Rodriguez ◽  
Robert Jones ◽  
C Paul Morris ◽  
David Ettinger ◽  
Sayanan Chowsilpa ◽  
...  
Keyword(s):  
Overall Survival ◽  
African American ◽  
African Americans ◽  
Pulmonary Adenocarcinoma ◽  
Institutional Review Board ◽  
Control Group ◽  
Molecular Alterations ◽  
Molecular Tests ◽  
Institutional Review Board Approval ◽  
Institutional Review

ABSTRACT Objectives Identify molecular alterations in pulmonary adenocarcinoma (ADC) in African American (AA) patients diagnosed on cytology specimens. Methods After institutional review board approval, we searched our database from 2013 to 2017 for AA patients with a diagnosis of pulmonary ADC. Molecular and clinical data were reviewed. White patients also diagnosed with pulmonary ADC on cytology samples formed a control group. Results A total of 113 patients were identified. Mean age was 63.4 years. Molecular tests were available for 91 patients. Mutations were identified in 53 (58.2%) cases. The most common mutations were EGFR (n = 19 cases, 36%) and KRAS (n = 24 cases, 45%). When compared with whites, AA patients were diagnosed at higher stages (P = .045) and demonstrated shorter overall survival (17 vs 47 months, P = .0150). No differences were noted regarding distribution of molecular alterations. Conclusion AA patients have similar molecular alterations in ADCs as their white counterparts. However, they have worse outcomes.

scholarly journals Multicentre randomised double-blinded placebo-controlled trial of favipiravir in adults with mild COVID-19

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e047495
Author(s):  
Mohammad Bosaeed ◽  
Ahmad Alharbi ◽  
Mohammad Hussein ◽  
Mohammed Abalkhail ◽  
Khizra Sultana ◽  
...  
Keyword(s):  
Randomised Trial ◽  
Disease Onset ◽  
Dropout Rate ◽  
Institutional Review Board ◽  
Research Centre ◽  
Control Group ◽  
Ministry Of Health ◽  
Link Type ◽  
Institutional Review ◽  
Novel Coronavirus

IntroductionA novel coronavirus, designated SARS-CoV-2, caused an international outbreak of a respiratory illness, termed COVID-19 in December 2019. There is a lack of specific therapeutic agents based on evidence for this novel coronavirus infection; however, several medications have been evaluated as a potential therapy. Therapy is required to treat symptomatic patients and decrease the virus carriage duration to limit the communitytransmission.Methods and analysisWe hypothesise that patients with mild COVID-19 treated with favipiravir will have a shorter duration of time to virus clearance than the control group. The primary outcome is to evaluate the effect of favipiravir on the timing of the PCR test conversion from positive to negative within 15 days after starting the medicine.Adults (>18 years, men or nonpregnant women, diagnosed with mild COVID-19 within 5 days of disease onset) are being recruited by physicians participating from the Ministry of National Guard Health Affairs and the Ministry of Health ethics committee approved primary healthcare centres. This double-blind, randomised trial comprises three significant parts: screening, treatment and a follow-up period. The treating physician and patients are blinded. Eligible participants are randomised in a 1:1 ratio to either the therapy group (favipiravir) or a control group (placebo) with 1800 mg by mouth two times per day for the first day, followed by 800 mg two times per day for 4–7 days. Serial nasopharyngeal/oropharyngeal swab samples are obtained on day 1 (5 days before therapy). On day5±1 day, 10±1 day, 15±2 days, extra nasopharyngeal/oropharyngeal PCR COVID-19 samples are requested.The primary analysis population for evaluating both the efficacy and safety outcomes will be a modified intention to treat population. Anticipating a 10% dropout rate, we expect to recruit 288 subjects per arm. The results assume that the hazard ratio is constant throughout the study and that the Cox proportional hazard regression is used to analyse the data.Ethics and disseminationThe study was approved by the King Abdullah International Medical Research Centre Institutional Review Board (28 April 2020) and the Ministry of Health Institutional Review Board (1 July 2020). Protocol details and any amendments will be reported to https://clinicaltrials.gov/ct2/show/NCT04464408. The results will be published in peer-reviewed journals.Trial registration numberNational Clinical Trial Registry (NCT04464408).

scholarly journals Driving After Total Ankle Arthroplasty

2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0008
Author(s):  
Elizabeth McDonald ◽  
David Pedowitz ◽  
Rachel Shakked ◽  
Joseph Daniel ◽  
Kristen Nicholson ◽  
...  
Keyword(s):  
Total Ankle Arthroplasty ◽  
Institutional Review Board ◽  
Control Group ◽  
Analog Scale ◽  
Ankle Arthroplasty ◽  
Patient Demographics ◽  
Institutional Review Board Approval ◽  
Institutional Review ◽  
Age Range ◽  
Arthroplasty Surgery

Category: Ankle Introduction/Purpose: With the increase in number of total ankle arthroplasty surgery, physician guidelines on when to begin to consider patients’ return to driving is valuable. The ability to accurately and efficiently determine when a patient can return to driving is important both from a patient safety and a medicolegal perspective. The purpose of the study was to determine when patients’ brake reaction time (BRT) returns to a safe value after right total ankle arthroplasty. We also aimed to identify predictive factors that may identify those patients who may not be safe to drive. Methods: After institutional review board approval, fifty-five patients undergoing right total ankle arthroplasty were recruited prospectively. Patient demographics include an age range of 43 to 83 years (median 63 years), of which 31 were male (56%) and 24 were female (44%). BRT was tested at six weeks and repeated weekly until patients achieved a passing BRT. A control group of twenty healthy patients was used to establish a passing BRT of 0.850 seconds. Patients were given a validated, novel driver readiness survey to complete of which a 10/15 point or higher score was considered passing. Results: At 6 weeks, 50 patients (91%) achieved a passing BRT and were considered safe to drive, and the passing group average BRT was 0.662 seconds. At 9 weeks, 52 patients (100%) of those who completed the study achieved a passing BRT. Patients that failed at 6 weeks had statistically greater visual analog scale (VAS) for pain (p=0.037) and significantly diminished ankle plantarflexion (p=0.029). There is a significant (p<0.001) and large (r=-0.455) correlation between BRT and the validated driver readiness survey scores. 5/5 (100%) patients that failed the BRT also failed the driver readiness survey (p=0.049). Interestingly, males were more likely to think they were ready to drive based on their driver readiness survey but were no more likely to pass the BRT than females (p=0.002). Conclusion: Over 90% of patients may be eligible to return to driving as early as 6 weeks post-operatively. Indications that a patient is not safe to return to driving at 6 weeks are higher VAS, limited plantarflexion, and a failed driver readiness survey. Although many factors determine whether a patient may safely return to driving, patients may be informed that BRT normalizes 9 weeks after right total ankle arthroplasty.

scholarly journals Acceptability and barriers to implementation of N-of-1 tests in Ethiopia - a qualitative study

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Chalachew Alemayehu ◽  
Geoff Mitchell ◽  
Jane Nikles ◽  
Abraham Aseffa ◽  
Alexandra Clavarino
Keyword(s):  
Qualitative Study ◽  
Regulatory Authority ◽  
Generic Drugs ◽  
Clinical Care ◽  
Cost Effective ◽  
Analysis Data ◽  
Institutional Review Board ◽  
Therapeutic Equivalence ◽  
Drug Regulatory Authority ◽  
Institutional Review

Abstract Background Locally produced generic drugs offer a cost–effective alternative to imported drugs to treat patients in Ethiopia. However, due to a lack of bioequivalence testing, additional assurance tests are needed to build trust in cheaper, locally made drugs. By testing bioequivalence of local drugs to gold standard, N-of-1 tests have the potential to promote patient centred quality use of medicines. Method We sought to assess the acceptability of, and explore barriers to, conducting N-of-1 tests to evaluate local medicines in a resource limited clinical setting. We conducted a descriptive qualitative study, analysing four focus group discussions and five key informant interviews. Participants were senior drug regulatory authority members, institutional review board members, physicians and patients. All interviews were audio taped and transcribed verbatim. Patient interviews were conducted in Amharic and translated to English prior to analysis. Data analysis used an inductive, thematic process. Results Five major themes were identified; (1) Appropriateness of N-of-1 tests to determine the therapeutic equivalence of local drugs, (2) N-of-1 therapeutic equivalence tests: clinical care or research? (3) Ethical and regulatory requirements (IRB), (4) Potential barriers to implementing N-of-1 tests and (5) Possible solutions to identified challenges. The study demonstrated considerable support for using N-of-1 tests for clinical equivalence studies between local and imported medicines, but important impediments were very likely to impact the feasibility of conducting N-of-1 tests in Ethiopia. Key informants from the regulatory authority did not support additional tests of local drugs. There were also mixed opinions regarding ethical requirements for conducting N-of-1 tests. The Institutional Review Board (IRB) members believed that IRB approval was sufficient to conduct N-of-1 tests, however, the regulatory authority members considered that N-of-1 tests constituted a clinical trial, and required approval at the regulatory level. Conclusion This study showed that there were key uncertainties that could impact the feasiblity of using N-of-1 testing local drugs in Ethiopia. Therefore, a number of protocol amendments to address contextual threats and regulatory challenges, would be needed before progressing to conducting these tests.

scholarly journals The Impact of NORTH STAR on Suicidality, Substance Problems, Intimate Partner Violence, and Child Abuse

2020 ◽  
Author(s):  
Amy M Smith Slep ◽  
Richard E Heyman ◽  
Michael F Lorber ◽  
David J Linkh
Keyword(s):  
Intimate Partner Violence ◽  
Child Abuse ◽  
Air Force ◽  
Partner Violence ◽  
Absolute Risk ◽  
Intimate Partner ◽  
Institutional Review Board ◽  
Cross Sectional ◽  
Institutional Review ◽  
The Impact

Abstract Introduction We evaluated the effectiveness of New Orientation for Reducing Threats to Health from Secretive-problems That Affect Readiness (NORTH STAR), a community assessment, planning, and action framework to reduce the prevalence of suicidality, substance problems, intimate partner violence, and child abuse. Materials and Methods One-third of U.S. Air Force bases worldwide were randomly assigned to NORTH STAR (n = 12) or an assessment-and-feedback-only condition (n = 12). Two Air Force-wide, cross-sectional, anonymous, web-based surveys were conducted of randomly selected samples assessing risk/protective factors and outcomes. This study was reviewed and approved by the institutional review board at the investigators’ university and by the institutional review board at Fort Detrick. Results NORTH STAR, relative to control, bases experienced a 33% absolute risk reduction in hazardous drinking rates and cumulative risk, although, given the small number of bases, these effects were not statistically significant. Conclusions Given its relatively low cost, use of empirically supported light-touch interventions, and emphasis on sustainability with existing resources, NORTH STAR may be a useful system for prevention of a range of adult behavioral health problems that are difficult to impact.

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