Acceptance and Commitment group Therapy for patients with multiple functional somatic syndromes: a three-armed trial comparing ACT in a brief and extended version with enhanced care

2018 ◽  
Vol 49 (6) ◽  
pp. 1005-1014 ◽  
Author(s):  
Heidi Frølund Pedersen ◽  
Johanne L. Agger ◽  
Lisbeth Frostholm ◽  
Jens S. Jensen ◽  
Eva Ørnbøl ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Psychological Treatment ◽  
Secondary Outcome ◽  
Health Improvement ◽  
Extended Version ◽  
Functional Somatic Syndromes ◽  
Global Improvement ◽  
Acceptance And Commitment ◽  
Significant Difference ◽  
Secondary Outcomes

AbstractBackgroundPsychological treatment for functional somatic syndromes (FSS) has been found moderately effective. Information on how much treatment is needed to obtain improvement is sparse. We assessed the efficacy of a brief and extended version of group-based Acceptance and Commitment Therapy (ACT) v. enhanced care (EC) for patients with multiple FSS operationalised as Bodily Distress Syndrome multi-organ type.MethodsIn a randomised controlled three-armed trial, consecutively referred patients aged 20–50 with multiple FSS were randomly assigned to either (1) EC; (2) Brief ACT: EC plus 1-day workshop and one individual consultation; or (3) Extended ACT: EC plus nine 3-h group-based sessions. Primary outcome was patient-rated overall health improvement on the five-point clinical global improvement scale 14 months after randomisation. A proportional odds model was used for the analyses.ResultsA total of 180 patients were randomised; 60 to EC, 61 to Brief ACT, and 59 to Extended ACT. Improvement on the primary outcome after Extended ACT was significantly greater than after EC with an unadjusted OR of 2.9 [95% CI (1.4–6.2), p = 0.006]. No significant differences were found between Brief ACT and EC. Of the 18 secondary outcomes, the only significant difference found was for physical functioning in the comparison of Extended ACT with EC.ConclusionsPatients rated their overall health status as more improved after Extensive ACT than after EC; however, clinically relevant secondary outcome measures did not support this finding. Discrepancies between primary and secondary outcomes in this trial are discussed.

scholarly journals 1611. Evaluating Clinical Outcomes and Efficacy of Daptomycin in Combination with a Beta-Lactam for the Treatment of Vancomycin-Resistant Enterococcus (VRE) Bacteremia

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S799-S800
Author(s):  
Nerea Irusta ◽  
Ana Vega ◽  
Yoichiro Natori ◽  
Lilian M Abbo ◽  
Lilian M Abbo ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Primary Outcome ◽  
Small Sample Size ◽  
Univariate Analysis ◽  
Small Sample ◽  
Significant Difference ◽  
Vancomycin Resistant ◽  
Secondary Outcomes ◽  
Related Mortality

Abstract Background In-vitro studies have shown synergistic bactericidal activity with daptomycin (DAP) plus β-lactam antimicrobials against vancomycin resistant enterococci (VRE). There is a paucity of data regarding clinical outcomes with this combination in VRE bloodstream infections (BSI). The purpose of this study was to assess the efficacy of DAP plus a β-lactam with in-vitro activity vs. other therapies for treatment of VRE BSI. Methods IRB-approved, single-center, retrospective study of patients with VRE BSI from 01/2018-09/2019. Patients were excluded if < 18 years old, pregnant, or incarcerated. The primary outcome was time-to-microbiological clearance. Secondary outcomes included infection-related mortality, 30-day all-cause mortality, and incidence of recurrent BSI within 30 days of index culture. Targeted DAP doses were ≥ 8mg/kg and based on MIC. Factors associated with significance for outcomes, via univariate analysis, were evaluated with multivariable logistic regression (MLR), removed in a backward-step approach. Results A total of 85 patients were included, 23 of which received DAP plus a β-lactam. The comparator arm included linezolid or DAP monotherapy. Patients with combination therapy had significantly higher Charlson Comorbidity Index (CCI) (p=0.013) and numerically higher Pitt Bacteremia scores (PBS) (p=0.087) (Table 1). There was no difference seen in the primary outcome (Table 2). Secondary outcomes are provided in Table 2. The presence of polymicrobial infection and higher PBS were significantly associated with infection-related mortality (p=0.008 and p=0.005, respectively) by MLR. A Mann Whitney U test indicated that presence of infection-related mortality was greater for patients with higher MICS (U=20.5, p=0.06). The presence of an underlying source may be related to recurrence of BSI (p=0.075). Table 1: Patient Characteristics Table 2. Primary and Secondary Outcomes Conclusion We did not find a significant difference in time-to-microbiological clearance, although patients treated with DAP and a β-lactam had higher CCI and PBS. These results are limited by retrospective design, small sample size, and potential selection bias. Prospective randomized studies are needed to further validate these findings. Disclosures All Authors: No reported disclosures

System intervention in community pharmacy setting: Leading to better patient care through reducing harm associated with coprescribing benzodiazepines and opioids

2021 ◽  
Vol 17 (6) ◽  
pp. 445-453
Author(s):  
Angelina Vascimini, PharmD ◽  
Kevin Duane, PharmD ◽  
Stacey Curtis, PharmD
Keyword(s):  
Chart Review ◽  
Primary Outcome ◽  
Community Pharmacists ◽  
Retrospective Chart Review ◽  
Secondary Outcome ◽  
Post Intervention ◽  
Improvement Project ◽  
System Intervention ◽  
Secondary Outcomes ◽  
Pharmacy Setting

Objective: The opioid epidemic is frequently discussed including the staggering numbers involved with coprescribing opioids and benzodiazepines associated with death. Community pharmacists, with the help of a system intervention, have a unique opportunity to help reduce the coprescribing of benzodiazepines and opioids and reduce the associated risk of death.Design: A single center retrospective chart review was conducted after a system intervention was placed, as a quality improvement project, from November 2019 to May 2020.Setting: Independent community pharmacy.Patients/participants: Data included demographics, dosing of each medication pre- and post-intervention, and naloxone status.Main outcome(s) measures: The primary outcome evaluated was reduction in dose/discontinuation of these prescriptions. The secondary outcome evaluated was the number of naloxone prescriptions ordered per protocol and picked up.Results: The primary outcome did not show statistical difference; however, the secondary outcomes showed statistical significance.Conclusion: In conclusion, community pharmacists, with the help of evolving technologies, can reduce harm associated with the coprescribing of benzodiazepines and opioids.

Effect of Sustained Uterine Compression versus Uterine Massage on Blood Loss after Vaginal Delivery: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Labib M. Ghulmiyyah ◽  
Alaa El-Husheimi ◽  
Ihab M. Usta ◽  
Cristina Colon-Aponte ◽  
Ghina Ghazeeri ◽  
...  
Keyword(s):  
Blood Loss ◽  
Vaginal Delivery ◽  
Postpartum Hemorrhage ◽  
Primary Outcome ◽  
Dropout Rate ◽  
Significant Difference ◽  
Uterine Massage ◽  
Secondary Outcomes ◽  
Group 2 ◽  
Group 1

Objective This study aimed to compare the effectiveness of sustained uterine compression versus uterine massage in reducing blood loos after a vaginal delivery. Study Design This was a prospective randomized trial conducted at the American University of Beirut Medical Center (AUBMC) between October 2015 and October 2017. Inclusion criteria were women with a singleton pregnancy at ≥36 weeks of gestation, with less than three previous deliveries, who were candidates for vaginal delivery. Participants were randomized into two groups, a sustained uterine compression group (group 1) and a uterine massage group (group 2). Incidence of postpartum hemorrhage (blood loss of ≥500 mL) was the primary outcome. We assumed that the incidence of postpartum hemorrhage at our institution is similar to previously published studies. A total of 545 women were required in each arm to detect a reduction from 9.6 to 4.8% in the primary outcome (50% reduction) with a one-sided α of 0.05 and a power of 80%. Factoring in a 10% dropout rate. Secondary outcomes were admission to intensive care unit (ICU), postpartum complications, drop in hemoglobin, duration of hospital stay, maternal pain, use of uterotonics, or of surgical procedure for postpartum hemorrhage. Results A total of 550 pregnant women were recruited, 273 in group 1 and 277 in group 2. There was no statistically significant difference in baseline characteristics between the two groups. Type of anesthesia, rate of episiotomy, lacerations, and mean birth weight were also equal between the groups. Incidence of the primary outcome was not different between the two groups (group 1: 15.5%, group 2: 15.4%; p = 0.98). There was no statistically significant difference in any of the secondary outcomes between the two groups, including drop in hemoglobin (p = 0.79). Conclusion There was no difference in blood loss between sustained uterine compression and uterine massage after vaginal delivery. Key Points

scholarly journals 1033. Effectiveness of a Physician-Driven Automated Antibiotic Time Out in the Setting of Gram-negative Bacteremia

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S363-S364
Author(s):  
Sana Mohayya ◽  
Navaneeth Narayanan ◽  
Daniel Cimilluca ◽  
Parth Vaidya ◽  
Alexander Malanowski ◽  
...  
Keyword(s):  
Broad Spectrum ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Antibiotic Prescribing ◽  
Gram Negative ◽  
Time Out ◽  
Days Of Therapy ◽  
Gram Negative Bacteremia ◽  
Secondary Outcomes ◽  
The Impact

Abstract Background In an effort to minimize complications associated with over-utilization of antibiotics, many antimicrobial stewardship programs have incorporated an antibiotic time out (ATO). Despite the increasing adoption of the ATO, limited data are available to support its effectiveness. This study was designed to assess the impact of an automated ATO integrated into the electronic medical record (EMR) on the rate of antibiotic modification in patients receiving broad-spectrum antibiotic(s) for Gram-negative bacteremia (GNB). Methods This was a single-center retrospective cohort study of inpatients from January 2017 to June 2018 conducted at a large academic medical center. ATO was implemented on October 31, 2017. Adult patients with GNB who received at least 72 hours of a systemic antibiotic were included. Patients with neutropenia or polymicrobial infections were excluded. The primary outcome was the proportion of patients who received a modification of therapy within 24 hours of final culture results. Secondary outcomes included modification at any point in therapy, time to modification of therapy, time to de-escalation, and days of therapy of broad-spectrum antibiotics. Results There was a total of 88 patients who met inclusion criteria, 37 patients pre-ATO and 51 patients post-ATO. The primary outcome of modification of therapy within 24 hours of final culture results was not significantly different for patients in the pre-ATO and post-ATO groups (19% vs. 20%, P = 0.94, respectively). The secondary outcome of modification of therapy at any point in therapy was not significantly different between the two groups (62% vs. 66%, P = 0.67). Of the 47 patients who received a modification of therapy, the mean time to modification was significantly shorter in the post-ATO group (52.8 hours vs. 45.26 hours, P < 0.05,). All other secondary outcomes were not significantly different between study groups. Conclusion The ATO alert was not associated with a higher rate of antibiotic modification within 24 hours of culture results in patients with GNB, although there was a significant reduction in the time to antibiotic modification. Further efforts are needed to improve the time to modification and optimize antibiotic prescribing practices. Disclosures All authors: No reported disclosures.

scholarly journals Cybersecurity features of digital medical devices: an analysis of FDA product summaries

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e025374 ◽  
Author(s):  
Ariel Dora Stern ◽  
William J Gordon ◽  
Adam B Landman ◽  
Daniel B Kramer
Keyword(s):  
Medical Devices ◽  
Time Trends ◽  
Primary Outcome ◽  
Product Information ◽  
Healthcare Delivery ◽  
Recent Time ◽  
Secondary Outcome ◽  
Regulatory Documents ◽  
Secondary Outcomes ◽  
Premarket Approval

ObjectivesTo more clearly define the landscape of digital medical devices subject to US Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and cybersecurity features in regulated medical devices.DesignWe analysed data from publicly available FDA product summaries to understand the frequency and recent time trends of inclusion of software and cybersecurity content in publicly available product information.SettingThe full set of regulated medical devices, approved over the years 2002–2016 included in the FDA’s 510(k) and premarket approval databases.Primary and secondary outcome measuresThe primary outcome was the share of devices containing software that included cybersecurity content in their product summaries. Secondary outcomes were differences in these shares (a) over time and (b) across regulatory areas.ResultsAmong regulated devices, 13.79% were identified as including software. Among these products, only 2.13% had product summaries that included cybersecurity content over the period studied. The overall share of devices including cybersecurity content was higher in recent years, growing from an average of 1.4% in the first decade of our sample to 5.5% in 2015 and 2016, the most recent years included. The share of devices including cybersecurity content also varied across regulatory areas from a low of 0% to a high of 22.2%.ConclusionsTo ensure the safest possible healthcare delivery environment for patients and hospitals, regulators and manufacturers should work together to make the software and cybersecurity content of new medical devices more easily accessible.

scholarly journals Internet-based self-help randomized trial for motor functional neurologic disorder (SHIFT)

Neurology ◽  
2020 ◽  
Vol 95 (13) ◽  
pp. e1883-e1896
Author(s):  
Jeannette M. Gelauff ◽  
Judith G.M. Rosmalen ◽  
Alan Carson ◽  
Joke M. Dijk ◽  
Martijn Ekkel ◽  
...  
Keyword(s):  
Online Education ◽  
Usual Care ◽  
Social Adjustment ◽  
Stepped Care ◽  
Secondary Outcome ◽  
Global Improvement ◽  
Neurologic Disorder ◽  
Self Rated Health ◽  
Self Help ◽  
Secondary Outcomes

ObjectiveTo determine whether self-rated health of patients with motor functional neurologic disorder (FND) can be improved by unguided Internet-based self-help and education.MethodsIn this nonblinded randomized controlled trial, patients were allocated 1:1 unbiased to an unguided education and self-help website in addition to usual care or usual care only. Patients over 17 years of age with a functional motor symptom that caused distress or disability were included. The primary outcome was self-rated health on the Clinical Global Improvement scale at 3 and 6 months. Secondary outcomes were severity of motor symptoms, other physical and psychiatric symptoms, physical functioning, quality of life, work and social adjustment, illness beliefs, and satisfaction with care.ResultsA total of 186 patients were randomized, with a follow-up rate of 87% at 6 months. There was no difference in improvement of self-rated health at 3 months (44% vs 40%, p = 0.899) or 6 months (42% vs 43%, p = 0.435). Secondary outcomes did not differ between groups, with a threshold of p < 0.01. Satisfaction was high, with 86% of patients recommending the website to other patients.ConclusionWe found no significant effect of the intervention added to usual care on self-rated health or secondary outcome measures, despite high patient satisfaction with the intervention. These results suggest that online education and nonguided self-help could be valuable additions to stepped care for motor FND, but are not effective treatments as interventions in their own right.Clinicaltrials.gov identifierNCT02589886.Classification of evidenceThis study provides Class III evidence that for patients with motor FND, online education and self-help intervention does not significantly improve self-rated health.

A randomised controlled trial of perivenous tumescent anaesthesia in addition to general anaesthesia for surgical ligation and stripping of the great saphenous vein

2019 ◽  
Vol 35 (5) ◽  
pp. 305-315 ◽  
Author(s):  
Sandip Nandhra ◽  
Tom Wallace ◽  
Joseph El-Sheikha ◽  
Daniel Carradice ◽  
Ian Chetter
Keyword(s):  
Quality Of Life ◽  
General Anaesthesia ◽  
Saphenous Vein ◽  
Primary Outcome ◽  
Great Saphenous Vein ◽  
Bodily Pain ◽  
Secondary Outcome ◽  
Surgical Ligation ◽  
Significant Difference

Introduction Open surgical ligation and stripping of the great saphenous vein is a highly cost-effective treatment when compared with conservative management and foam sclerotherapy but has limitations including post-operative morbidity and pain. This study aims to identify if the addition of tumescent anaesthesia could improve patient outcomes following treatment. Methods Patients with primary superficial venous incompetence undergoing open surgical ligation and stripping of the great saphenous vein were randomised to either General Anaesthesia (GA) alone (GA) procedure or the addition of tumescent (G + T). The primary outcome was bodily pain (within SF-36) at one week. Additional outcomes included post-procedural pain score (100 mm visual analogue scale), complications and quality of life. Results A total of 90 patients were randomised for inclusion. There was no significant difference in primary outcome; bodily pain at one week. Secondary outcome of 4-h post-procedural scores were significantly lower in the G + T group (32 (20–54) mm vs. (GA alone) 56 (24–70) mm (P = 0.016)). Complications were minor and equivalent. Both groups saw a significant increase (worsening) in Aberdeen Varicose Vein Questionnaire scores at week 1 with the G + T group faring worse at six weeks (10.0 (Interquartile Range [IQR] 5.6–17.9) vs. 4.3 (IQR 2.7–7.9) P = 0.004). Conclusion The G + T group did not demonstrate a significant difference in the one-week bodily pain domain. The addition of tumescent anaesthesia does improve immediate post-operative pain but appears to negatively impact on six-week quality of life. EudraCT Number: 2011-005574-39

scholarly journals Efficiency and safety of ondansetron in preventing postanaesthesia shivering

2016 ◽  
Vol 98 (6) ◽  
pp. 358-366 ◽  
Author(s):  
k He ◽  
H Zhao ◽  
HC Zhou
Keyword(s):  
Lower Risk ◽  
Randomised Controlled Trials ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Meta Analysis ◽  
Primary Outcome Measure ◽  
Cochrane Library ◽  
Significant Difference ◽  
Secondary Outcomes ◽  
Randomised Controlled

Introduction Shivering is one of the most frequent complications of operation during the postanaesthesia period. Ondansetron has been proved to be valid in preventing postanaesthesia shivering (PAS) in several studies. However, its efficiency and safety are still disputable. We therefore performed an updated meta-analysis of randomised controlled trials (RCTs) for evaluation and to clarify this issue. Methods A literature search using the PubMed, Embase™ and Cochrane Library databases was performed (from inception to January 2015). RCTs that evaluated the efficiency and safety of ondansetron in the prevention of PAS were included in the meta-analysis. The primary outcome measure was incidence of PAS, and secondary outcomes included subgroup analysis and the side effects of ondansetron. Results A total of 8 RCTs containing 905 subjects were identified as suitable for this review. Compared with placebo, ondansetron was associated with a significant reduction of PAS (relative risk [RR]: 0.33, 95% confidence interval [CI]: 0.19–0.58, p=0.0001) while no difference was detected between ondansetron and pethidine (RR: 0.89, 95% CI: 0.41–1.94, p=0.78). There was no significant difference between ondansetron and placebo or pethidine in terms of risk of bradycardia but ondansetron was associated with a lower risk of hypotension (RR: 0.26, 95% CI: 0.08–0.79, p=0.020) than placebo. There was no difference in hypotension when ondansetron was compared with pethidine. Conclusions Ondansetron can prevent PAS effectively and reduce the risk of hypotension.

scholarly journals Role of Preoperative Calcium and Vitamin D Therapy to prevent Post-thyroidectomy Hypocalcemia

2020 ◽  
Author(s):  
Sunghwan suh ◽  
Ju Won Seok ◽  
Keunyoung Kim ◽  
Mi Kyoung Park ◽  
Kyoungjune Pak ◽  
...  
Keyword(s):  
Vitamin D ◽  
English Language ◽  
Primary Outcome ◽  
Potential Role ◽  
Meta Analysis ◽  
Vitamin D Supplementation ◽  
Secondary Outcome ◽  
Significant Difference ◽  
Symptomatic Hypocalcemia

Abstract Purpose: Postsurgical hypocalcemia is the most common and troublesome consequence of thyroidectomy. We investigated the potential role of routine calcium or vitamin D supplementation in preventing postsurgical hypocalcemia. Materials and Methods: We searched MEDLINE and EMBASE for English-language publications using the keywords “calcium”, “vitamin D”, and “thyroid cancer”. The primary outcome was any postoperative hypocalcemia, and the secondary outcome was symptomatic hypocalcemia. Results: Four studies that included 381 patients were eligible for this meta-analysis. The random-effects model showed no significant difference in the occurrence of hypocalcemia between calcium/vitamin D treatment and placebo/no treatment. The occurrence of symptomatic hypocalcemia was lower in patients with calcium/vitamin D treatment. In combined results, preoperative calcium and vitamin D supplementation was associated with a reduced incidence of symptomatic hypocalcemia.Conclusion: We support the use of preoperative calcium and vitamin D supplementation in conjunction with routine postsurgical supplementation for patients after total thyroidectomy.

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