1. There was no difference in initiation rates of buprenorphine-naloxone for patients with opioid use disorder (OUD) at emergency departments randomized to receive a clinical decision support tool, compared to those without the support tool.
2. A higher proportion of physicians at sites with the support tool initiated buprenorphine-naloxone at least once, compared to the control.
Evidence Rating Level: 1 (Excellent)
Currently, only approximately 19% of eligible individuals with opioid use disorder (OUD) in the USA receive treatment for OUD. For many individuals with OUD, the emergency department (ED) is an access point into the healthcare system, especially when patients are undergoing overdose or withdrawal. However, only 20.9% of ED clinicians felt comfortable starting buprenorphine-naloxone, an opioid agonist therapy (OAT) that is one of the most effective long-term treatments for OUD. Therefore, the authors of this cluster randomized controlled trial developed a clinical decision support tool to assist clinicians with initiating buprenorphine treatment in patients with OUD, to determine if this was associated with increased rates of initiation. This study was conducted at 18 clusters across 5 states, with constrained randomization to balance potential confounding characteristics in either group. 9 clusters comprising of 3820 OUD visits were randomized to care as usual, while the remaining 9 clusters comprising 3443 OUD visits were randomized to the intervention. All sites were educated on OUD and buprenorphine initiation, but only the intervention sites received the decision support tool, integrated into their electronic health record systems. Initiation was defined as receiving buprenorphine-naloxone in the ED or being prescribed it on discharge. Overall, the study found no difference in buprenorphine-naloxone initiation rates in the ED, with an initiation rate of 12.5% in the intervention and 12.0% in the usual care (adjusted odds ratio 1.22, 95% CI 0.61-2.43, p = 0.58). However, the percentage of attending physicians who initiated buprenorphine-naloxone at least once was greater in the intervention than the usual care arm (44.4% versus 34.0%, adjusted OR 1.83, 95% CI 1.16-2.89, p = 0.01). With regards to uptake, the decision support tool was used by 38.2% of physicians for 9.4% of OUD patients, and for visits where the tool was launched, buprenorphine was initiated 61.7% of the time. Altogether, this study did not find that buprenorphine-naloxone initiation was increased at sites with the decision support tool, although more physicians in the intervention than the control initiated it at least once, and there was low uptake of the decision tool at the intervention sites.
1. Participants randomized into smoking cessation training cessation sessions in community pharmacies in English and Wales were not found to have greater quit rates than control after a 11 month period.
2. There was no significant difference in the program retention rate and quit rate at 4 weeks between the pharmacies that received the training session and those that did not.
Evidence Rating Level: 1 (Excellent)
Smoking cigarettes is one of leading causes of preventable death worldwide, causing over 7 million deaths worldwide each year, with 1.2 million of the deaths being from environmental exposure to tobacco smoke. Smoking cessation has been found to be extremely effective to reduce premature mortality due to smoking at all ages. In England and Wales, the National Health Service (NHS) released a Stop Smoking Services (SSS) to provide free medication and behavioural supports for smoking cessation. These services are available in many different settings, including with general practitioners, at community pharmacies, and at specialist clinics. The NHS SSS reported a 52.4% rate of self-reported smoking cessation in 2018/2019 across all settings. However, in community pharmacies, quit rates were found to be much lower at 19%, due to a number of possible reasons including loss to follow up and poor subject selection. The STOP study was a cluster randomized controlled trial that recruited 60 pharmacies in England and Wales between April 2017 and February 2018 and randomized them in a 1:1 ratio to the intervention group and control group. The intervention was a training session involving role-plays and videos that targeted the engagement of smokers, including sessions on motivational interviewing. The primary outcome was the number ‘treated smokers’ – smokers who joined, set a firm quit date, and attended at least one consult on or before their set quit date. Between the two groups, there was no significant difference with respect to total number of treated smokers (IRR 0.75; 95% CI, 0.46-1.23, p=0.259). With respect to secondary outcomes, between the two groups, there was also no significant difference in treated smoker retention rate and quit rate at 4 weeks. Study findings suggest that comprehensive behavioural and communication skill based interventions provided by pharmacies may be an ineffective intervention tool to promote quitting cigarettes, though this will require further exploration in future studies.
1. In patients with post-cardiopulmonary bypass coagulopathy, therapy with prothrombin complex concentrate was similar in overall safety and efficacy and had fewer complications compared to plasma infusion.
Evidence Rating Level: 1 (Excellent)
In surgical practice, post-cardiopulmonary bypass (CPB) coagulopathy is one of the most frequent reasons for requiring blood transfusions. Contributing factors to coagulopathies post-surgery include thrombocytopenia, platelet dysfunction, and coagulation factor consumption and dilution. Patients with factor-mediated coagulopathy and bleeding post-CPB often receive large volume plasma transfusions; however, there are many risks of plasma transfusions including lung injury, infectious complications, and allergic reactions. In recent years, the use of prothrombin complex concentrates in the treatment of coagulation factor-mediated bleeding post-cardiac surgery is becoming increasingly common due to lower risks and complications compared to plasma transfusions. As such, this randomized control trial aimed to investigate the safety and efficacy of prothrombin complex concentrate (PCC) compared to using plasma in patients undergoing cardiac surgery. A total of 100 adult participants undergoing CPB were included. Participants were randomly assigned to receive either PCC or plasma and were required to have excessive microvascular bleeding, determined by prothrombin greater than 16.6 seconds, to be included in the final analysis. Postoperative bleeding, evaluated by chest tube output, was assessed in all patients. The results of this study showed that there was no significant difference in postoperative bleeding between the PCC and plasma groups (median 937, IQR 708-1443 and median 1022, IQR 799-1575, respectively). Additionally, fewer participants in the PCC group required intraoperative transfusion after therapy compared to the plasma group (13.6% and 30.6%, respectively) and 13.6% of PCC participants avoided allogenic transfusion as opposed to 0% in those receiving plasma. In conclusion, this trial indicates that in patients receiving cardiac surgery with coagulopathic complications, PCC may be a safer and more effective alternative to plasma transfusion. Given that this is the first randomized control trial comparing PCC and plasma in this context, further research investigating efficacy and long-term adverse events could be very valuable.
1. Following invasive or conservative management of chronic coronary disease, patients with CKD stage 5 were found to have a significantly higher 3-year cumulative incidence of death and nonfatal myocardial infarction than patients with CKD stage 1.
2. In patients who received either conservative or invasive management of chronic coronary disease, there was no significant difference in 3-year cumulative incidence of death or nonfatal myocardial infarction between the two groups across the different stages of chronic kidney disease.
3. Invasive management versus conservative management of chronic coronary disease was associated with significant improvement of quality-of-life parameters 1 year following randomization, as measured by the Seattle Angina Questionnaire summary score, in patients with CKD stages 1, 2, and 3, but not in CKD stages 4 and 5.
Evidence Rating Level: 2 (Good)
Previous trials comparing invasive versus conservative management of patients with chronic coronary disease (CCD) typically exclude or involve very few patients with severe kidney disease. Thus, current treatment guidelines for CCD are not based on evidence that includes varying levels of kidney function. Prior studies have found that decreased kidney function is associated with higher risks of invasive procedures and increased rates of cardiovascular events. Given this, kidney function often influences treatment decisions, and it is important to investigate for any heterogeneity of treatment benefit based on existing kidney function. The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial recruited patients with varying levels of kidney function. This study is a post-hoc analysis of the ISCHEMIA and ISCHEMIA-CKD trials. The ISCHEMIA trial recruited participants with CCD and randomized them in a 1:1 ratio to either invasive or conservative management. Invasive management included coronary angiography followed by revascularization with either percutaneous intervention or a coronary artery bypass graft in addition to guideline-directed medical therapy (GDMT), while the conservative management group received GDMT only. 5956 participants were included in this analysis with 1889 (32%), 2551 (43%), 738 (12%), 311 (5%), 467 (8%) patients in CKD stages 1, 2, 3, 4, and 5 respectively. The primary clinical outcome was death or nonfatal myocardial infarction (MI), while the primary quality of life (QoL) outcome was based on the Seattle Angina Questionnaire (SAQ) summary score at 1 year after randomization. Patients with CKD stage 5 were found to have a significantly greater 3-year cumulative incidence of death and MI than patients with CKD stage 1 (p<.001). However, in terms of heterogeneity of treatment benefit, there was no significant difference in death or MI between the invasive and conservative management groups across the spectrum of kidney disease (p=.62). With respect to QoL, invasive management was associated with a significant improvement in QoL parameters in patients with CKD stages 1-3 (p<.001), but this significant improvement was not present in patients with CKD stages 4 and 5.
1. There was no significant difference in smoking cessation between healthcare-based and community-based smoking cessation transitional care models at 6 months after hospital discharge.
2. The healthcare-based model had a higher proportion of patients than the community-based model that continued with tobacco cessation treatment.
Evidence Rating Level: 2 (Good)
Cigarette smoking is one of the leading preventable causes of death in the United States, and 3.2 million adults who smoke are admitted to hospital annually. Hospital admission provides a unique opportunity for patients to attempt smoking cessation, with counselling that begins in hospital and continues after discharge. Previous research has found this counselling strategy to be associated with a 37% increase in tobacco abstinence rate at 6 months after discharge. There are two existing models that facilitate the transition of smoking cessation from the inpatient to the outpatient setting: the transitional tobacco care management model (TTCM), which keeps post-discharge treatment within the healthcare system, and the quitline electronic referral model (QL), which transfers treatment to a community-based resource. This study randomized patients in a 1:1 ratio to either the TTCM or QL group, with a primary outcome of self-reported past 7-day tobacco abstinence at 6 month follow up confirmed biochemically. Between September 2018 and March 2020, 1409 patients from the Massachusetts General Hospital, the University of Pittsburg Medical Center, and the Vanderbilt University Medical Center were enrolled into the study. At 1 and 3 months after discharge, the TTCM group had significantly higher 7-day tobacco abstinence rates than the QL group. However, at 6 months, tobacco abstinence did not differ significantly between the groups (TTCM: 19.9%; QL: 16.9%; RR, 1.18; 95% CI, 0.92-1.50; p=.19). With respect to use of tobacco cessation treatment, which includes pharmacotherapy and counselling, the TTCM group had a significantly higher proportion of patients than the QL group that reported current use of tobacco cessation treatment at 1 and 3 months. At 6 months, this significant difference persisted with use of cessation medication, but not counselling support.
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