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"Tertiary Care Centers - organization "
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Effectiveness of integrative medicine group visits in chronic pain and depressive symptoms: A randomized controlled trial
by
D’Amico, Salvatore
,
Gergen-Barnett, Katherine
,
Gardiner, Paula
in
Academic Medical Centers - organization & administration
,
Adult
,
Aged
2019
Current treatment options for chronic pain and depression are largely medication-based, which may cause adverse side effects. Integrative Medical Group Visits (IMGV) combines mindfulness techniques, evidence based integrative medicine, and medical group visits, and is a promising adjunct to medications, especially for diverse underserved patients who have limited access to non-pharmacological therapies.
Determine the effectiveness of IMGV compared to a Primary Care Provider (PCP) visit in patients with chronic pain and depression.
9-week single-blind randomized control trial with a 12-week maintenance phase (intervention-medical groups; control-primary care provider visit).
Academic tertiary safety-net hospital and 2 affiliated federally-qualified community health centers.
159 predominantly low income racially diverse adults with nonspecific chronic pain and depressive symptoms.
IMGV intervention- 9 weekly 2.5 hour in person IMGV sessions, 12 weeks on-line platform access followed by a final IMGV at 21 weeks.
Data collected at baseline, 9, and 21 weeks included primary outcomes depressive symptoms (Patient Health Questionnaire 9), pain (Brief Pain Inventory). Secondary outcomes included pain medication use and utilization.
There were no differences in pain or depression at any time point. At 9 weeks, the IMGV group had fewer emergency department visits (RR 0.32, 95% CI: 0.12, 0.83) compared to controls. At 21 weeks, the IMGV group reported reduction in pain medication use (Odds Ratio: 0.42, CI: 0.18-0.98) compared to controls.
Absence of treatment assignment concealment for patients and disproportionate group attendance in IMGV.
Results demonstrate that low-income racially diverse patients will attend medical group visits that focus on non-pharmacological techniques, however, in the attention to treat analysis there was no difference in average pain levels between the intervention and the control group.
clinicaltrials.gov NCT02262377.
Journal Article
A Randomized Clinical Trial of Three Options for N95 Respirators and Medical Masks in Health Workers
by
Shi, Weixian
,
Rahman, Bayzid
,
Seale, Holly
in
Adult
,
Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
,
Biological and medical sciences
2013
Abstract
Rationale
We compared three policy options for the use of medical masks and N95 respirators in healthcare workers (HCWs).
Objectives
A cluster randomized clinical trial of 1,669 hospital-based HCWs in Beijing, China in the winter of 2009–2010.
Methods
Participants were randomized to medical masks, N95 respirators, or targeted use of N95 respirators while doing high-risk procedures or barrier nursing. Outcomes included clinical respiratory illness (CRI) and laboratory-confirmed respiratory pathogens in symptomatic subjects.
Measurements and Main Results
The rate of CRI was highest in the medical mask arm (98 of 572; 17%), followed by the targeted N95 arm (61 of 516; 11.8%), and the N95 arm (42 of 581; 7.2%) (P < 0.05). Bacterial respiratory tract colonization in subjects with CRI was highest in the medical mask arm (14.7%; 84 of 572), followed by the targeted N95 arm (10.1%; 52 of 516), and lowest in the N95 arm (6.2%; 36 of 581) (P = 0.02). After adjusting for confounders, only continuous use of N95 remained significant against CRI and bacterial colonization, and for just CRI compared with targeted N95 use. Targeted N95 use was not superior to medical masks.
Conclusions
Continuous use of N95 respirators was more efficacious against CRI than intermittent use of N95 or medical masks. Most policies for HCWs recommend use of medical masks alone or targeted N95 respirator use. Continuous use of N95s resulted in significantly lower rates of bacterial colonization, a novel finding that points to more research on the clinical significance of bacterial infection in symptomatic HCWs. This study provides further data to inform occupational policy options for HCWs.
Clinical trial registered with Australian New Zealand Clinical Trials Registry http://www.anzctr.org.au (ACTRN 12609000778280).
Journal Article
Digital Physiotherapeutic Ankle-Specific Training System for Patients With Chronic Ankle Instability Following Modified Brostrom Surgery: Noninferiority Randomized Controlled Trial at a Tertiary Grade A Trauma Center in China
2025
Functional rehabilitation is commonly used for patients with chronic ankle instability (CAI). Digital training (DT) systems have become increasingly popular in postoperative rehabilitation; however, their effectiveness for CAI patients after modified Brostrom surgery (MBS) is uncertain. Furthermore, specialized physiotherapy resources for CAI are limited in some regions, highlighting the need for effective digital home-based rehabilitation alternatives.
This trial aimed to evaluate whether individually tailored physiotherapeutic ankle-specific training (PAST) delivered via a DT system is noninferior to conventional face-to-face physiotherapy in clinical outcomes and to compare their cost-effectiveness in CAI patients following MBS in China.
We conducted a 2-arm, single-blinded (assessor), noninferiority randomized controlled trial at a tertiary hospital in Shanghai, China, from January 2022 to January 2024. A total of 84 postsurgery CAI patients were randomly assigned to a DT group (n=42), which received a 12-week individualized PAST program via a digital system, or a physiotherapy group (n=42), which received standard face-to-face physiotherapy for 12 weeks. Assessments were performed at baseline, 12 weeks, and 24 weeks postoperatively. The primary outcomes were 2 subscales of the Foot and Ankle Ability Measure, with a noninferiority margin of 8 points for Foot and Ankle Ability Measure-Activities of Daily Living (FAAM-ADL) and 9 points for Foot and Ankle Ability Measure-Sports (FAAM-S). Secondary outcomes included balance tests (time-in-balance, foot-lift, and star excursion balance), functional tests (ankle dorsiflexion range of motion, side-hop, and figure-8 hop), and quality of life (FAAM questionnaire). We also collected intervention costs to evaluate cost-effectiveness. Statistical analyses included between-group comparisons of outcomes and nonparametric bootstrapping to calculate incremental cost-effectiveness ratios.
Baseline characteristics were similar between groups (except for a difference in foot-lift test performance). By the 24-week follow-up, improvements in the primary outcomes were comparable between the DT and physiotherapy groups, with adjusted between-group differences of 0.36 (95% CI -1.01 to 1.72) for FAAM-ADL and 1.67 (95% CI -0.61 to 3.96) for FAAM-S. These differences fell within the predefined noninferiority margins, demonstrating noninferiority of the digital program. No significant between-group differences were observed in secondary outcomes (all P>.05). The average cost per patient was lower in the DT group (CNY 53,551; an exchange rate of US $1=CNY 7 was applied) than in the physiotherapy group (CNY 59,372), yielding an incremental cost of CNY -14,451 in favor of the digital intervention. The bootstrapped incremental cost-effectiveness ratios were CNY -16,396 for FAAM-ADL and CNY -114,131 for FAAM-S, indicating that DT was more cost-effective.
Individually tailored PAST delivered via a DT system was found to be clinically noninferior to conventional face-to-face physiotherapy and more cost-effective, supporting its use as a viable rehabilitation alternative for CAI patients after MBS.
Journal Article
Randomised Trial of Oral Misoprostol versus Manual Vacuum Aspiration for the Treatment of Incomplete Abortion at a Nigerian Tertiary Hospital
by
Kehinde Ibiyemi
,
Munir'deen Ijaiya
,
Kikelomo Adesina
in
ABORTION
,
Abortion, Incomplete - therapy
,
Abortion, Induced - adverse effects
2019
Objectives : This study aimed to compare the efficacy of oral misoprostol with manual vacuum aspiration
(MVA) in first trimester incomplete abortions. Methods : This randomised controlled trial study was conducted
at the University of Ilorin Teaching Hospital, Ilorin, Nigeria between April 2014 and November 2015. Pregnant
women who presented with clinical features of incomplete abortion at a gestational age of 13 weeks or less were
included. Patients who had profuse vaginal bleeding, an intrauterine device in situ, signs of pelvic infections or who
were younger than 18 years old and had no accompanying adults to give informed consent were excluded. A total
of 200 participants were randomly and equally allocated to either the MVA or misoprostol treatment group. The
treatment group were given 600 μg of misoprostol orally. The primary outcome measure was complete uterine evacuation,
while secondary outcome measures included the need for additional surgical evacuation for failed treatment,
adverse effects/complications, acceptability of and satisfaction with the treatment. Results : Both misoprostol and
MVA had high complete evacuation rates, yet MVA was significantly higher (99% versus 83%, relative risk [RR] : 0.84,
confidence interval [CI]: 0.766–0.918; P < 0.001). Significantly more women in the misoprostol group required additional
MVA for failed treatment than in the MVA treatment group (17% versus 1%, RR: 16.67, CI: 2.260–12.279; P <0.001).
No significant difference was found between the misoprostol and MVA treatment groups in terms of satisfaction
(92.7 % versus 89.8 %, RR : 1.04, CI : 0.946–1.127; P = 0.473). Conclusion : Treatments with misoprostol and MVA had
high complete uterine evacuation rates, as well as high rates of acceptability and satisfaction. However, MVA had a
significantly higher complete evacuation rate than misoprostol.
Journal Article
Automated anesthesia carts reduce drug recording errors in medication administrations — A single center study in the largest tertiary referral hospital in China
2017
To clinically evaluate a type of patented automated anesthesia cart in medication administrations in anesthesia.
This was a prospectively randomized open label clinical trial. In 10 designated operating suits in the First Affiliated Hospital of Zhengzhou University, in China. 1066 cases originated from 10,812 medication administrations in anesthesia were randomized. 78 registered anesthesiologists managed the medication. The patients received medication administrations in anesthesia with either an automated or a conventional manual cart. American Society of Anesthesiologists (ASA) score, sex, duration of anesthesia and surgical specialty, errors in administration of medications (incorrect medication given (substitution), medication not given (omission) and drug recordings errors”), compliance and satisfaction were recorded.
The total error rate was 7.3% with the automated anesthesia carts (1 in 14 administrations) and 11.9% with conventional manual carts (1 in 8 administrations). Automated anesthesia carts significantly reduced the drug recording error rate compared to conventional manual carts (P<0.01). However, no significant difference of substitution or errors omission errors was found between groups of automated anesthesia carts and conventional manual carts. The anesthesiologists' compliance with the automated anesthesia carts was unsatisfactory, and all the errors in medication recordings with the automated anesthesia carts were due to the incorrect use of the carts. Most of the participating anesthesiologists preferred the automated anesthesia carts (P<0.05).
The utilization of automated anesthesia carts reduced the drug recording errors in medication administrations of anesthesia.
•Automated anesthesia carts reduced the error rate;•Anesthesiologists' compliance to the automated anesthesia carts was not satisfactory;•Most of the participating anesthesiologists preferred the automated anesthesia carts.
Journal Article
Computerized physician order entry and decision support improves ED analgesic ordering for renal colic
by
Lang, Eddy
,
Lonergan, Kevin
,
Netherton, Stuart J.
in
Adult
,
Analgesics
,
Analgesics - therapeutic use
2014
Computerized physician order entry (CPOE) offers the potential for safer, faster patient care, as well as greater use of evidence-based therapy via built-in decision support. However, the effectiveness of CPOE in yielding these benefits has shown mixed results in the emergency department (ED) setting. Our objective was to evaluate the impact of CPOE implementation on analgesic prescribing and dosing practices for renal colic presentations.
This retrospective pre/post comparative study was conducted in 3 tertiary hospitals that implemented CPOE in 2010. Two patient groups were compared: prior to (pre-CPOE) and after (post-CPOE) CPOE implementation. Each group consisted of 230 randomly selected, high-acuity patients presenting to the ED with renal colic. The primary outcome was the proportion of patients receiving ketorolac in the ED. Secondary outcomes included choice of analgesic and average morphine dose.
The proportion of patients receiving ketorolac significantly increased after CPOE implementation (65.6% pre-CPOE vs 76.5% post-CPOE, P = .015), as did the proportion of patients receiving fentanyl (pre, 9.7%; post, 16.7%; P = .047). Differences in morphine use (pre, 66.0%; post, 69.1%) and average morphine dose (pre, 10.09 mg; post, 12.28 mg) did not reach statistical significance.
The introduction of CPOE is associated with an increase in ketorolac use for ED renal colic visits. This may reflect the inclusion of ketorolac in the renal colic order set. Computerized physician order entry implementation with condition-specific electronic order sets and decision support may improve evidence-based practice.
Journal Article
Position Paper for the Organization of Extracorporeal Membrane Oxygenation Programs for Acute Respiratory Failure in Adult Patients
by
Gattinoni, Luciano
,
Slutsky, Arthur
,
Pesenti, Antonio
in
Adult
,
Adults
,
Ambulances - organization & administration
2014
The use of extracorporeal membrane oxygenation (ECMO) for severe acute respiratory failure (ARF) in adults is growing rapidly given recent advances in technology, even though there is controversy regarding the evidence justifying its use. Because ECMO is a complex, high-risk, and costly modality, at present it should be conducted in centers with sufficient experience, volume, and expertise to ensure it is used safely. This position paper represents the consensus opinion of an international group of physicians and associated health-care workers who have expertise in therapeutic modalities used in the treatment of patients with severe ARF, with a focus on ECMO. The aim of this paper is to provide physicians, ECMO center directors and coordinators, hospital directors, health-care organizations, and regional, national, and international policy makers a description of the optimal approach to organizing ECMO programs for ARF in adult patients. Importantly, this will help ensure that ECMO is delivered safely and proficiently, such that future observational and randomized clinical trials assessing this technique may be performed by experienced centers under homogeneous and optimal conditions. Given the need for further evidence, we encourage restraint in the widespread use of ECMO until we have a better appreciation for both the potential clinical applications and the optimal techniques for performing ECMO.
Journal Article
Effect of a facility-based multifaceted intervention on the quality of obstetrical care: a cluster randomized controlled trial in Mali and Senegal
by
Zunzunegui, Maria-Victoria
,
Traoré, Mamadou
,
Dumont, Alexandre
in
Cause of Death - trends
,
Clinical Audit - methods
,
Clinical Audit - statistics & numerical data
2013
Background
Maternal mortality in referral hospitals in Mali and Senegal surpasses 1% of obstetrical admissions. Poor quality obstetrical care contributes to high maternal mortality; however, poor care is often linked to insufficient hospital resources. One promising method to improve obstetrical care is maternal death review. With a cluster randomized trial, we assessed whether an intervention, based on maternal death review, could improve obstetrical quality of care.
Methods
The trial began with a pre-intervention year (2007), followed by two years of intervention activities and a post-intervention year. We measured obstetrical quality of care in the post-intervention year using a criterion-based clinical audit (CBCA). We collected data from 32 of the 46 trial hospitals (16 in each trial arm) and included 658 patients admitted to the maternity unit with a trial of labour. The CBCA questionnaire measured 5 dimensions of care- patient history, clinical examination, laboratory examination, delivery care and postpartum monitoring. We used adjusted mixed models to evaluate differences in CBCA scores by trial arms and examined how levels of hospital human and material resources affect quality of care differences associated with the intervention.
Results
For all women, the mean percentage of care criteria met was 66.3 (SD 13.5). There were significantly greater mean CBCA scores in women treated at intervention hospitals (68.2) compared to control hospitals (64.5). After adjustment, women treated at intervention sites had 5 points’ greater scores than those at control sites. This difference was mostly attributable to greater clinical examination and post-partum monitoring scores. The association between the intervention and quality of care was the same, irrespective of the level of resources available to a hospital; however, as resources increased, so did quality of care scores in both arms of the trial.
Trial registration
The QUARITE trial is registered on the Current Controlled Trials website under
ISRCTN46950658
Journal Article
Life-threatening massive pulmonary embolism rescued by venoarterial-extracorporeal membrane oxygenation
2017
Background
Despite quick implementation of reperfusion therapies, a few patients with high-risk, acute, massive, pulmonary embolism (PE) remain highly hemodynamically unstable. Others have absolute contraindication to receive reperfusion therapies. Venoarterial-extracorporeal membrane oxygenation (VA-ECMO) might lower their right ventricular overload, improve hemodynamic status, and restore tissue oxygenation.
Methods
ECMO-related complications and 90-day mortality were analyzed for 17 highly unstable, ECMO-treated, massive PE patients admitted to a tertiary-care center (2006–2015). Hospital- discharge survivors were assessed for long-term health-related quality of life. A systematic review of this topic was also conducted.
Results
Seventeen high-risk PE patients [median age 51 (range 18–70) years, Simplified Acute Physiology Score II (SAPS II) 78 (45–95)] were placed on VA-ECMO for 4 (1–12) days. Among 15 (82%) patients with pre-ECMO cardiac arrest, seven (41%) were cannulated during cardiopulmonary resuscitation, and eight (47%) underwent pre-ECMO thrombolysis. Pre-ECMO median blood pressure, pH, and blood lactate were, respectively: 42 (0–106) mmHg, 6.99 (6.54–7.37) and 13 (4–19) mmol/L. Ninety-day survival was 47%. Fifteen (88%) patients suffered in-ICU severe hemorrhages with no impact on survival. Like other ECMO-treated patients, ours reported limitations of all physical domains but preserved mental health 19 (4–69) months post-ICU discharge.
Conclusions
VA-ECMO could be a lifesaving rescue therapy for patients with high-risk, acute, massive PE when thrombolytic therapy fails or the patient is too sick to benefit from surgical thrombectomy. Because heparin-induced clot dissolution and spontaneous fibrinolysis allows ECMO weaning within several days, future studies should investigate whether VA-ECMO should be the sole therapy or completed by additional mechanical clot-removal therapies in this setting.
Journal Article
Factors associated with respectful maternity care during hospital deliveries: A cross-sectional study in Bangladesh
2025
Respectful provision of care is an integral component of quality maternity care service. The objective of the present study was to assess the status of respectful maternity care and its associated factors in public and private hospitals in Bangladesh.
A cross-sectional study was conducted at a tertiary care public hospital and a tertiary care private hospital in Chittagong, Bangladesh from October 2023 to September 2024. Face-to-face interviews using a structured questionnaire was conducted to collect data from postnatal women. Respectful maternity care was measured using a validated 15-item tool with four domains (friendly, abuse-free, timely, and discrimination-free care). Logistic regression analysis was used to identify factors associated with respectful maternity care.
A number of 264 postnatal women from the public hospital and 334 from the private hospital were included in the study. Overall, 55.5% of them received respectful maternity care, with significant differences between public (33.7%) and private (72.8%) hospitals (p-value <0.001). Women in private hospitals reported higher standards across all domains, with the largest disparity in discrimination-free care (98% in private vs. 56% in public hospitals, p < 0.001). Logistic regression showed that women in private hospitals (adjusted odds ratio, aOR 18.10; 95% confidence interval, CI 8.43-42.0), those with facility-level referrals (aOR 2.88; 95% CI 1.59-5.31), and cesarean deliveries (aOR 2.45; 95% CI 1.26-5.07) were significantly more likely to receive respectful maternity care.
Respectful maternity care was significantly more likely among women delivering in private hospitals, through facility-level referrals, and by cesarean section, indicating gaps in public hospital practices that require attention to ensure respectful care for all mothers.
Journal Article