Confidence Intervals

Low dose colchicine taken after an MI or stroke for at least 6 months reduces the risk of subsequent MI or stroke with minimal adverse effects (mostly GI). James W. Mold, MD, MPH

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Rationale
People with cardiovascular disease are at risk of recurrent major adverse cardiovascular events, and chronic low‐grade inflammation may be a major underlying factor. Treatment with low‐dose colchicine has been proposed for the secondary prevention of cardiovascular events in individuals at high cardiovascular risk. A previous Cochrane review showed considerable uncertainty regarding the benefits and harms of this approach.

Objectives
To evaluate the benefits and harms of low‐dose colchicine in the prevention of cardiovascular events in adults with a history of stable CVD or following myocardial infarction or stroke.

Search methods
We conducted a comprehensive search of the literature until February 2025 using Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the drugs@FDA database, references of key papers, and references of included studies.

Eligibility criteria
Randomised controlled trials (RCTs) comparing the use of low‐dose colchicine for a minimum of six months versus any control intervention in patients of any age with cardiovascular disease (i.e. history of stable cardiovascular disease, previous myocardial infarction or stroke).

Outcomes
Our critical outcomes were all‐cause mortality, myocardial infarction, and serious adverse events.

Our important outcomes were cardiovascular mortality, stroke, all‐cause hospitalisations, coronary revascularisation (percutaneous coronary intervention (PCI)/angioplasty or coronary artery bypass graft (CABG)), quality of life, and gastrointestinal adverse events (i.e. diarrhoea, nausea, abdominal pain, or vomiting).

Risk of bias
Two authors independently assessed the risk of bias using the Cochrane RoB2 tool.

Synthesis methods
We conducted meta‐analyses using the random‐effects model. We generated forest plots to facilitate visualisation of the data. We did not perform any subgroup analysis.

We used GRADE to assess the certainty of evidence for all critical outcomes and for cardiovascular mortality, stroke, and coronary revascularisation. This was carried out by two review authors working independently.

Included studies
We included 12 studies involving 22,983 randomised participants. The follow‐up in the studies ranged from 6 to 80 months. Overall, 11,524 participants were assigned to low‐dose colchicine treatment and 11,459 were assigned to a control intervention, which constituted either usual care plus placebo or usual care only. The doses of colchicine used were 0.5 mg once or twice daily. At baseline, the mean age of participants ranged from 57 to 74 years. Most participants (79.4%) were male.

Synthesis of results
There is high‐certainty evidence that low‐dose colchicine treatment reduces the risk of myocardial infarction, with a risk ratio (RR) of 0.74 (95% confidence interval (CI) 0.57 to 0.96; 22,153 participants, 8 studies; I2 = 51%), yielding an absolute risk reduction of 9 fewer events (95% CI 16 fewer to 2 fewer) per 1000 patients, when the myocardial infarction rate is about 4% (36 events per 1000 patients) in the control group.

There is also high‐certainty evidence that low‐dose colchicine reduces the risk of stroke with a RR of 0.67 (95% CI 0.47 to 0.95; 22,483 participants, 10 studies; I2 = 40%), yielding an absolute risk reduction of 8 fewer events (95% CI 12 fewer to 1 fewer) per 1000 patients, when the stroke rate is about 2% (22 events per 1000 patients) in the control group.

There is high‐certainty evidence that the use of low‐dose colchicine does not increase the rate of serious adverse events (RR 0.98, 95% CI 0.94 to 1.02; 15,677 participants, 4 studies; I2 = 0%). However, gastrointestinal adverse events were more common under treatment with colchicine (RR 1.68, 95% CI 1.11 to 2.57; 22,185 participants, 10 studies; I2 = 91%).

For all other outcomes assessed, the evidence is of moderate certainty. Colchicine probably results in little to no difference in all‐cause mortality (RR 1.01, 95% CI 0.84 to 1.21; 22,747 participants, 10 studies; I2 = 1%; moderate‐certainty evidence), in cardiovascular mortality (RR 0.94, 95% CI 0.73 to 1.22; 22,271 participants; 8 studies; I2 = 13%; moderate‐certainty evidence), and coronary revascularisation (RR 0.83, 95% CI 0.64 to 1.08; 13,705 participants, 5 studies; I2 = 40%; moderate‐certainty evidence).

There is no evidence about the benefits or harms of colchicine on quality‐of‐life or on the risk of all‐cause hospitalisation.

Authors' conclusions
People with cardiovascular disease using low‐dose colchicine as secondary prevention for at least six months benefit from reduced rates of myocardial infarction and stroke, without an increase in serious adverse events. Moderate‐certainty evidence did not show a benefit from low‐dose colchicine for the risk of mortality (i.e. all‐cause and cardiovascular mortality) or coronary revascularisation rates. Colchicine use was associated with an increased risk of gastrointestinal adverse events, which were typically described as mild and transient in nature. Additional studies are warranted to investigate the benefits and harms of low‐dose colchicine in relevant subgroups and in specific indications, such as long‐term use in individuals with stable coronary artery disease versus limited‐time use following acute coronary syndrome.

Funding
Review author FE was supported by the Margot und Erich Goldschmidt & Peter René Jacobson Foundation. Review author CMS was supported by the Janggen Pöhn Foundation and the Swiss National Science Foundation (MD‐PhD grant Number: 323530_221860).

Registration
This review is based on its protocol, which is available via DOI 10.1002/14651858.CD014808, and a previous review, which is available via DOI 10.1002/14651858.CD011047.pub2.

Author/s:

Fahim Ebrahimi, Ramin Ebrahimi, Maximilian Beer, Christof Manuel Schönenberger, Hannah Ewald, Matthias Briel, Perrine Janiaud, Julian Hirt

Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity

Hope Smashey — Wed, 08 Oct 2025 00:39:43 +0000

Date Added:

October 7, 2025

Journal/Publication:

New England Journal of Medicine

Publication Date:

September 18, 2025

Issue:

Volume:

393

URL:

Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMoa2500969

Keywords

Semaglutide

overweight

PMID (1):

40934115

MeSH

Oral semaglutide 25mg daily resulted in a 14% reduction in weight in 1.4 years. James W. Mold, MD, MPH

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Background
Oral semaglutide at a dose of 25 mg may provide an alternative treatment option to injectable semaglutide (2.4 mg) and higher-dose oral semaglutide (50 mg) for persons with overweight or obesity.

Methods
In a 71-week, double-blind, randomized, placebo-controlled trial conducted at 22 sites in four countries, we enrolled persons without diabetes who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 30 or higher or a BMI of 27 or higher with at least one obesity-related complication. The participants were randomly assigned in a 2:1 ratio to receive oral semaglutide (25 mg) or placebo once daily, plus lifestyle interventions. The coprimary end points at week 64 were the percent change in body weight and a reduction of 5% or more in body weight; confirmatory secondary end points included reductions in body weight of 10% or more, 15% or more, and 20% or more and the change in the Impact of Weight on Quality of Life–Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score.

Results
A total of 205 participants were randomly assigned to receive oral semaglutide, and 102 to receive placebo. The estimated mean change in body weight from baseline to week 64 was −13.6% in the oral semaglutide group and −2.2% in the placebo group (estimated difference, −11.4 percentage points; 95% confidence interval, −13.9 to −9.0; P<0.001). Participants in the oral semaglutide group were significantly more likely than those in the placebo group to have body-weight reductions of 5% or more, 10% or more, 15% or more, and 20% or more (P<0.001 for all comparisons) and to have an improved IWQOL-Lite-CT Physical Function score (P<0.001). Gastrointestinal adverse events were more common with oral semaglutide than with placebo (74.0% vs. 42.2%).

Conclusions
Oral semaglutide at a dose of 25 mg once daily resulted in a greater mean reduction in body weight than placebo in participants with overweight or obesity. (Funded by Novo Nordisk; OASIS 4 ClinicalTrials.gov number, NCT05564117.)

Author/s:

Sean Wharton, Ildiko Lingvay, Pawel Bogdanski, Ruben Duque do Vale, Stephan Jacob, Tobias Karlsson, Chaithra Shaji, Domenica Rubino, W. Timothy Garvey

Aspirin in Patients with Chronic Coronary Syndrome Receiving Oral Anticoagulation

Megan George — Tue, 02 Sep 2025 13:36:10 +0000

Date Added:

September 2, 2025

Journal/Publication:

New England Journal of Medicine

Publication Date:

August 30, 2025

URL:

Aspirin in Patients with Chronic Coronary Syndrome Receiving Oral Anticoagulation

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMoa2507532

Keywords

Chronic Coronary Syndrome

Oral Anticoagulation

aspirin

atherothrombotic risk

stent implantation

PMID (1):

40888725

MeSH

aspirin

Fibrinolytic Agents

follow-up studies

Clinical Trials Data Monitoring Committees

Confidence Intervals

random allocation

myocardial infarction

coronary artery disease

In patients with high-risk CAD already on an anticoagulant, the addition of aspirin increases the risk of adverse events. James W. Mold, MD, MPH

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Background: The appropriate antithrombotic regimen for patients with chronic coronary syndrome who are at high atherothrombotic risk and receiving long-term oral anticoagulation remains unknown.

Methods: We conducted a multicenter, double-blind, randomized, placebo-controlled trial in France involving patients with chronic coronary syndrome who had undergone a previous stent implantation (>6 months before enrollment) and were at high atherothrombotic risk and currently receiving long-term oral anticoagulation. The patients were randomly assigned in a 1:1 ratio to receive aspirin (100 mg once daily) or placebo; all the patients continued to receive their current oral anticoagulation therapy. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, stroke, systemic embolism, coronary revascularization, or acute limb ischemia. The key safety outcome was major bleeding.

Results: A total of 872 patients underwent randomization; 433 were assigned to the aspirin group, and 439 to the placebo group. The trial was stopped early at the advice of the independent data and safety monitoring board after a median follow-up of 2.2 years because of an excess of deaths from any cause in the aspirin group. A primary efficacy outcome event occurred in 73 patients (16.9%) in the aspirin group and in 53 patients (12.1%) in the placebo group (adjusted hazard ratio, 1.53; 95% confidence interval [CI], 1.07 to 2.18; P = 0.02). Death from any cause occurred in 58 patients (13.4%) in the aspirin group and in 37 (8.4%) in the placebo group (adjusted hazard ratio, 1.72; 95% CI, 1.14 to 2.58; P = 0.01). Major bleeding occurred in 44 patients (10.2%) in the aspirin group and in 15 patients (3.4%) in the placebo group (adjusted hazard ratio, 3.35; 95% CI, 1.87 to 6.00; P<0.001). A total of 467 and 395 serious adverse events were reported in the aspirin group and placebo group, respectively.

Conclusions: Among patients with chronic coronary syndrome at high atherothrombotic risk who were receiving an oral anticoagulant, the addition of aspirin led to a higher risk of cardiovascular death, myocardial infarction, stroke, systemic embolism, coronary revascularization, or acute limb ischemia than placebo, as well as higher risks of death from any cause and major bleeding. (Funded by the French Ministry of Health and Bayer Healthcare; ClinicalTrials.gov number, NCT04217447.).

Author/s:

Gilles Lemesle, M.D., Ph.D., Romain Didier, M.D., Ph.D., Philippe Gabriel Steg, M.D., Tabassome Simon, M.D., Ph.D., Gilles Montalescot, M.D., Ph.D., Nicolas Danchin, M.D., Christophe Bauters, M.D., Ph.D.

Effects of Tai Chi and Qigong on cognitive and physical functions in older adults: systematic review, meta-analysis, and meta-regression of randomized clinical trials

Aubrey Delammermore — Wed, 14 Jun 2023 05:00:00 +0000

Date Added:

June 14, 2023

Journal/Publication:

BMC Geriatrics

Publisher:

BioMed Central

Publication Date:

June 6, 2023

Issue:

Volume:

Pages:

352

URL:

Effects of Tai Chi and Qigong on cognitive and physical functions in older adults: systematic review, meta-analysis, and meta-regression of randomized clinical trials

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1186/s12877-023-04070-2

Keywords

PMID (1):

37280512

MeSH

Qigong

Tai Chi

Confidence Intervals

Effect Modifier, Epidemiologic

Electronics

More evidence that we should all be doing Tai Chi, at least those of us of a certain age. James W. Mold, MD, MPH

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Background: Older adults experience age-related declines in physical and cognitive functions due to interactions between aging and chronic diseases. Tai Chi and Qigong (TCQ) might be beneficial in improving the physical function and delaying the cognitive decline of this population. The potential underlying mechanism was explored to determine the effects of TCQ on cognitive function via direct or indirect pathways.

Purpose: The objective of this systematic review was to determine the effects of TCQ on cognitive and physical functions in older adults using meta-analysis, and to determine the impact of TCQ on cognitive function while controlling for physical function using a meta-regression approach.

Methods: A systematic search of 13 electronic databases (in English, Korean, and Chinese languages) identified 10,292 potentially eligible studies published between inception and May 2022. The bias in individual studies was assessed using the Cochrane Risk of Bias (version 2.0) tool. The heterogeneity of the studies was evaluated using a 95% prediction interval, and the meta-analysis and meta-regression were implemented using the Comprehensive Meta-Analysis (version 3) software.

Results: Our search identified 17 randomized studies (n = 2,365, mean age = 70.3 years). The results of the meta-analysis that used a random-effects model indicated that TCQ had significant effects on both cognitive (Hedges' g = 0.29, 95% confidence interval [CI] = 0.17 to 0.42) and physical (Hedges' g = 0.32, 95% CI = 0.19 to 0.44) functions. We used meta-regression to explore the effect size of TCQ in association with physical function level. The regression model was significant (Q = 25.01, p = .070), and 55% of the heterogeneity was explained by physical function as a moderator variable. The effects of TCQ on cognitive function remained significant in this model when controlling for the effect of physical function (β = 0.46, p = .011).

Conclusion: This meta-regression of 17 randomized studies strongly suggests that TCQ has beneficial effects on physical and cognitive functions in older adults. The effect of TCQ on cognitive function remained significant after taking into account the significant effects of physical function as a moderator. The findings imply the potential health benefits of TCQ by promoting cognitive function in older adults directly and indirectly through enhancing physical function. PROSPERO REGISTRATION NUMBER: *PROSPERO international prospective register of systematic reviews, registration ID CRD42023394358.

Author/s:

Park, M., Song, R., Ju, K., Shin, J. C., Sea, J., Fan, X., Gao, X., Ryu, A., Li, Y.

Sacral Neuromodulation for Neurogenic Lower Urinary Tract Dysfunction

Aubrey Delammermore — Tue, 25 Oct 2022 05:00:00 +0000

Date Added:

October 25, 2022

Journal/Publication:

New England Journal of Medicine Evidence

Publisher:

Massachusetts Medical Society

Publication Date:

July 7, 2022

Issue:

Volume:

URL:

Sacral Neuromodulation for Neurogenic Lower Urinary Tract Dysfunction

Type:

Clinical Research Results

Format:

Article

Keywords

Sacral Neuromodulation

Lower Urinary Tract Dysfunction

referral and consultation

Odds Ratio

Randomized Controlled Trials as Topic

MeSH

Electric Stimulation Therapy

Many patients with various forms of neurogenic bladder (neurogenic lower urinary tract dysfunction) appear to benefit significantly from sacral neuromodulation, a fairly simple, reversible surgical procedure. James W. Mold, MD, MPH

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BACKGROUND
Neurogenic lower urinary tract dysfunction (NLUTD) is a highly prevalent and disabling condition; nevertheless, standard treatments often remain unsatisfactory. Sacral neuromodulation (SNM) is a well-established therapy for non-NLUTD, but there is a lack of randomized controlled trials to show benefit in patients with NLUTD.

METHODS
For this sham-controlled, double-blind, multicenter trial, patients with refractory NLUTD (and intended SNM) were recruited at four Swiss SNM referral centers. After lead placement into the sacral foramina S3 (rarely, S4), all participants underwent SNM testing. If successful (≥50% improvement in key bladder diary variables), the neurostimulator was implanted for permanent stimulation. For 2 months, neuromodulation was optimized using subsensory stimulation with individually adjusted parameters. Thereafter, the neurostimulator remained on or was switched off (1:1 random allocation to group SNM ON or SNM OFF, respectively) for 2 months, followed by a neurourologic reevaluation. The primary outcome was success, as defined above, of SNM compared with baseline.

RESULTS
Of 124 patients undergoing SNM testing, 65 (52%) had successfully improved lower urinary tract function. Of these, 60 patients (median age, 49.5 years; 43 women) were randomly assigned to the intervention. After 2 months of intervention, the SNM ON group demonstrated a success rate of 76%. In the SNM OFF group, 42% of patients showed sustained SNM effects despite their neurostimulator being switched off during the last 2 months (odds ratio, 4.35; 95% confidence interval, 1.43 to 13.21; P=0.009). During the entire study period, there were 11 adverse events (6 dropouts; no dropouts during the intervention phase).

CONCLUSIONS
SNM effectively corrected refractory NLUTD in the short term in well-selected neurologic patients. (Funded by the Swiss National Science Foundation, Vontobel–Stiftung, Gottfried und Julia Bangerter–Rhyner Stiftung, Dr. Urs Mühlebach, and the Swiss Continence Foundation; ClinicalTrials.gov number, NCT02165774.)

Author/s:

Liechti, M. D., van der Lely, S., Knüpfer, S. C., Abt, D., Kiss, B., Lietner, L., Mordasini, L., Tornic, J., Wöllner, J., Mehnert, U., Bachmann, L. M., Burkhard, F. C., Engeler, D. S., Pannek, J., Kessler, T. M.

The Effectiveness of Intraosseous Basivertebral Nerve Radiofrequency Ablation for the Treatment of Vertebrogenic Low Back Pain: An Updated Systematic Review with Single-Arm Meta-analysis

Aubrey Delammermore — Wed, 27 Jul 2022 05:00:00 +0000

Date Added:

July 27, 2022

Journal/Publication:

Pain Medicine

Publisher:

Oxford University Press

Publication Date:

July 20, 2022

Issue:

Issue Supplement 2

Volume:

Pages:

S50-S62

URL:

The Effectiveness of Intraosseous Basivertebral Nerve Radiofrequency Ablation for the Treatment of Vertebrogenic Low Back Pain: An Updated Systematic Review with Single-Arm Meta-analysis

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1093/pm/pnac070

Keywords

PMID (1):

35856331

MeSH

Confidence Intervals

low back pain

Visual Analog Scale

Radiofrequency Ablation

MEDLINE

Basi-vertebral nerve radiofrequency ablation is a new approach to management of chronic low back pain that appears to be fairly effective though more research is needed. James W. Mold, MD, MPH

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Objective. To provide an estimate of the effectiveness of basivertebral nerve (BVN) radiofrequency ablation (RFA) to
treat vertebrogenic low back pain (LBP). Design. Systematic review with single-arm meta-analysis. Population.
Persons 18 years of age with chronic LBP associated with type 1 or 2 Modic changes. Intervention. Intraosseous
BVN RFA. Comparison. Sham, placebo procedure, active standard care treatment, or none. Outcomes. The proportion
of patients treated with BVN RFA who reported 50% pain score improvement on a visual analog scale or numeric
rating scale. The main secondary outcome was 15-point improvement in Oswestry Disability Index score. Methods.
Three reviewers independently assessed articles published before December 6, 2021, in MEDLINE and Embase. The
Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) framework was used to evaluate
the overall quality of evidence. Results. Of the 856 unique records screened, 12 publications met the inclusion criteria,
representing six unique study populations, with 414 participants allocated to receive BVN RFA. Single-arm metaanalysis showed a success rate of 65% (95% confidence interval [CI] 51–78%) and 64% (95% CI 43–82%) for 50%
pain relief at 6 and 12 months, respectively. Rates of 15-point Oswestry Disability Index score improvement were
75% (95% CI 63–86%) and 75% (95% CI 63–85%) at 6 and 12 months, respectively. Conclusion. According to GRADE,
there is moderate-quality evidence that BVN RFA effectively reduces pain and disability in most patients with vertebr

Author/s:

Conger, A., Burnham, T. R., Clark, T., Teramoto, M, McCormick, Z. L.

The frequency and impact of undiagnosed benign paroxysmal positional vertigo in outpatients with high falls risk

Bethie Seay — Thu, 18 Nov 2021 06:00:00 +0000

Date Added:

November 18, 2021

Journal/Publication:

British Geriatrics Society

Publication Date:

June 11, 2021

Issue:

Volume:

Pages:

2025-2030

Type:

Clinical Research Results

DOI (1):

10.1093/ageing/afab122

MeSH

Benign Paroxysmal Positional Vertigo

Accidental Falls

Social Isolation

Cross-Sectional Studies

Benign positional vertigo may be a more common cause of falls in older people than we thought. It’s certainly worth looking for since it is treatable.

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Background
The frequency and impact of undiagnosed benign paroxysmal positional vertigo (BPPV) in people identified with high falls risk has not been investigated.

Objective
To determine the frequency and impact on key psychosocial measures of undiagnosed BPPV in adult community rehabilitation outpatients identified with a high falls risk.

Design
A frequency study with cross-sectional design.

Setting
A Community Rehabilitation Program in Melbourne, Australia.

Subjects
Adult community rehabilitation outpatients with a Falls Risk for Older People in the Community Screen score of four or higher.

Methods
BPPV was assessed in 34 consecutive high falls risk rehabilitation outpatients using the Dix–Hallpike test and supine roll test. Participants were assessed for anxiety, depression, fear of falls, social isolation and loneliness using the Hospital Anxiety and Depression Scale, Falls Efficacy Scale-International and De Jong Gierveld 6-Item Loneliness Scale.

Results
A total of 18 (53%; 95% confidence interval: 36, 70) participants tested positive for BPPV. There was no significant difference between those who tested positive for BPPV and those who did not for Falls Risk for Older People in the Community Screen scores (P = 0.555), Hospital Anxiety and Depression Scale (Anxiety) scores (P = 0.627), Hospital Anxiety and Depression Scale (Depression) scores (P = 0.368) or Falls Efficacy Scale-International scores (P = 0.481). Higher scores for the De Jong Gierveld 6-Item Loneliness Scale in participants with BPPV did not reach significance (P = 0.056).

Conclusions
Undiagnosed BPPV is very common and associated with a trend towards increased loneliness in adult rehabilitation outpatients identified as having a high falls risk.

Author/s:

Hawke, L. J., Barr, C. J., McLoughlin, J. V.

Effect of age on treatment outcomes in benign paroxysmal positional vertigo: A systematic review

Bethie Seay — Sun, 14 Nov 2021 06:00:00 +0000

Date Added:

November 14, 2021

Journal/Publication:

Journal of the American Geriatric Society

Publication Date:

October 26, 2021

Type:

Meta-analyses, Reviews, and Guidelines

DOI (1):

10.1111/jgs.17485

MeSH

Humans

aged

Benign Paroxysmal Positional Vertigo

Outcome Assessment, Health Care

Causality

PubMed

Older patients with benign positional vertigo may need more than one canalith-repositioning procedure to achieve resolution.

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Background
Benign paroxysmal positional vertigo (BPPV) can lead to an increased fall risk in older adults. Therefore, we examined the influence of age on the effectiveness of canalith-repositioning procedures (CRPs) for the treatment of BPPV.

Methods
Pubmed, Web of Science, and the bibliographies of selected articles were searched for studies conducted before September 2020 that examined the effectiveness of treatments for BPPV in various age groups. Meta-analyses were performed to compare treatment effectiveness and recurrence rates for younger and older adults. Odds ratios were calculated in a random-effects model. Mean differences were calculated using a fixed-effects model. A significance level of p < 0.05 (95% confidence interval) was set. The risk of bias and the methodological quality of all included articles were examined.

Results
Forty-five studies were retrieved after full-text screening, of which 29 studies were included for a qualitative review. The remaining 16 studies were eligible for inclusion in the meta-analysis (3267 participants with BPPV). The success rate of a single CRP was higher in the younger group (72.5% vs. 67%, p < 0.001). An average of 1.4 and 1.5 CRPs was needed for complete recovery in the younger and older groups, respectively (p = 0.02). However, global treatment success did not differ between these groups (97.5% vs. 94.6%, p = 0.41). The recurrence rate was higher in the older population (23.2% vs. 18.6%, p = 0.007).

Conclusions
Although more CRPs are needed, the rate of complete recovery in older adults is similar to that observed in younger adults.

Author/s:

Laurent, G., Vereeck, L., Verbecque, E., Herssens, N., Casters, L., Spildooren, J.

Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain

Bethie Seay — Tue, 02 Nov 2021 05:00:00 +0000

Date Added:

November 2, 2021

Journal/Publication:

Agency for Healthcare Research and Quality

Publication Date:

October 27, 2021

Issue:

Volume:

Pages:

EHC036

Type:

Meta-analyses, Reviews, and Guidelines

DOI (1):

10.23970/AHRQEPCCER250

This is a summary of the evidence available to date on cannabis and other plant-based treatments for chronic pain.

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Objectives. To evaluate the evidence on benefits and harms of cannabinoids and similar plant-based compounds to treat chronic pain.

Data sources. Ovid® MEDLINE®, PsycINFO®, Embase®, the Cochrane Library, and SCOPUS® databases, reference lists of included studies, submissions received after Federal Register request were searched to July 2021.

Review methods. Using dual review, we screened search results for randomized controlled trials (RCTs) and observational studies of patients with chronic pain evaluating cannabis, kratom, and similar compounds with any comparison group and at least 1 month of treatment or followup. Dual review was used to abstract study data, assess study-level risk of bias, and rate the strength of evidence. Prioritized outcomes included pain, overall function, and adverse events. We grouped studies that assessed tetrahydrocannabinol (THC) and/or cannabidiol (CBD) based on their THC to CBD ratio and categorized them as high-THC to CBD ratio, comparable THC to CBD ratio, and low-THC to CBD ratio. We also grouped studies by whether the product was a whole-plant product (cannabis), cannabinoids extracted or purified from a whole plant, or synthetic. We conducted meta-analyses using the profile likelihood random effects model and assessed between-study heterogeneity using Cochran’s Q statistic chi square and the I2 test for inconsistency. Magnitude of benefit was categorized into no effect or small, moderate, and large effects.

Results. From 2,850 abstracts, 20 RCTs (N=1,776) and 7 observational studies (N=13,095) assessing different cannabinoids were included; none of kratom. Studies were primarily short term, and 75 percent enrolled patients with a variety of neuropathic pain. Comparators were primarily placebo or usual care. The strength of evidence (SOE) was low, unless otherwise noted. Compared with placebo, comparable THC to CBD ratio oral spray was associated with a small benefit in change in pain severity (7 RCTs, N=632, 0 to10 scale, mean difference [MD] −0.54, 95% confidence interval [CI] −0.95 to −0.19, I2=28%; SOE: moderate) and overall function (6 RCTs, N=616, 0 to 10 scale, MD −0.42, 95% CI −0.73 to −0.16, I2=24%). There was no effect on study withdrawals due to adverse events. There was a large increased risk of dizziness and sedation and a moderate increased risk of nausea (dizziness: 6 RCTs, N=866, 30% vs. 8%, relative risk [RR] 3.57, 95% CI 2.42 to 5.60, I2=0%; sedation: 6 RCTs, N=866, 22% vs. 16%, RR 5.04, 95% CI 2.10 to 11.89, I2=0%; and nausea: 6 RCTs, N=866, 13% vs. 7.5%, RR 1.79, 95% CI 1.20 to 2.78, I2=0%). Synthetic products with high-THC to CBD ratios were associated with a moderate improvement in pain severity, a moderate increase in sedation, and a large increase in nausea (pain: 6 RCTs, N=390 to 10 scale, MD −1.15, 95% CI −1.99 to −0.54, I2=39%; sedation: 3 RCTs, N=335, 19% vs. 10%, RR 1.73, 95% CI 1.03 to 4.63, I2=0%; nausea: 2 RCTs, N=302, 12% vs. 6%, RR 2.19, 95% CI 0.77 to 5.39; I²=0%). We found moderate SOE for a large increased risk of dizziness (2 RCTs, 32% vs. 11%, RR 2.74, 95% CI 1.47 to 6.86, I2=0%). Extracted whole-plant products with high-THC to CBD ratios (oral) were associated with a large increased risk of study withdrawal due to adverse events (1 RCT, 13.9% vs. 5.7%, RR 3.12, 95% CI 1.54 to 6.33) and dizziness (1 RCT, 62.2% vs. 7.5%, RR 8.34, 95% CI 4.53 to 15.34). We observed a moderate improvement in pain severity when combining all studies of high-THC to CBD ratio (8 RCTs, N=684, MD −1.25, 95% CI −2.09 to −0.71, I2=50%; SOE: moderate). Evidence on whole-plant cannabis, topical CBD, low-THC to CBD, other cannabinoids, comparisons with active products, and impact on use of opioids was insufficient to draw conclusions. Other important harms (psychosis, cannabis use disorder, and cognitive effects) were not reported.

Conclusions. Low to moderate strength evidence suggests small to moderate improvements in pain (mostly neuropathic), and moderate to large increases in common adverse events (dizziness, sedation, nausea) and study withdrawal due to adverse events with high- and comparable THC to CBD ratio extracted cannabinoids and synthetic products in short-term treatment (1 to 6 months). Evidence for whole-plant cannabis, and other comparisons, outcomes, and PBCs were unavailable or insufficient to draw conclusions. Small sample sizes, lack of evidence for moderate and long-term use and other key outcomes, such as other adverse events and impact on use of opioids during treatment, indicate that more research is needed.

Author/s:

McDonagh, M. S., Wagner, J., Ahmed, A. Y., Morasco, B., Kansagara, D., Chou, R.

Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel

Saige Blanchard — Thu, 07 Oct 2021 23:14:35 +0000

Date Added:

October 7, 2021

Journal/Publication:

New England Journal of Medicine

Publisher:

Massachusetts Medical Society

Pages:

1-10

URL:

Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMoa2109730

Keywords

PMID (1):

34614328

MeSH

Coronavirus

retrospective studies

During active surveillance in Israel, the incidences of symptomatic myocarditis following the Pfizer COVID vaccine were on the order of 1 (after first dose) to 4 (after the second dose) per 100,000 for males and .1/ 100,000 and 0.5 per 100,000 for females. However, the rates were 1.5/100,00 (after first dose) and 13/100,000 (after second dose) in males 16 – 24 years of age. James W. Mold, MD, MPH

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Background: Approximately 5.1 million Israelis had been fully immunized against coronavirus disease 2019 (Covid-19) after receiving two doses of the BNT162b2 messenger RNA vaccine (Pfizer-BioNTech) by May 31, 2021. After early reports of myocarditis during adverse events monitoring, the Israeli Ministry of Health initiated active surveillance.

Methods: We retrospectively reviewed data obtained from December 20, 2020, to May 31, 2021, regarding all cases of myocarditis and categorized the information using the Brighton Collaboration definition. We analyzed the occurrence of myocarditis by computing the risk difference for the comparison of the incidence after the first and second vaccine doses (21 days apart); by calculating the standardized incidence ratio of the observed-to-expected incidence within 21 days after the first dose and 30 days after the second dose, independent of certainty of diagnosis; and by calculating the rate ratio 30 days after the second dose as compared with unvaccinated persons.

Results: Among 304 persons with symptoms of myocarditis, 21 had received an alternative diagnosis. Of the remaining 283 cases, 142 occurred after receipt of the BNT162b2 vaccine; of these cases, 136 diagnoses were definitive or probable. The clinical presentation was judged to be mild in 129 recipients (95%); one fulminant case was fatal. The overall risk difference between the first and second doses was 1.76 per 100,000 persons (95% confidence interval [CI], 1.33 to 2.19), with the largest difference among male recipients between the ages of 16 and 19 years (difference, 13.73 per 100,000 persons; 95% CI, 8.11 to 19.46). As compared with the expected incidence based on historical data, the standardized incidence ratio was 5.34 (95% CI, 4.48 to 6.40) and was highest after the second dose in male recipients between the ages of 16 and 19 years (13.60; 95% CI, 9.30 to 19.20). The rate ratio 30 days after the second vaccine dose in fully vaccinated recipients, as compared with unvaccinated persons, was 2.35 (95% CI, 1.10 to 5.02); the rate ratio was again highest in male recipients between the ages of 16 and 19 years (8.96; 95% CI, 4.50 to 17.83), with a ratio of 1 in 6637.

Conclusions: The incidence of myocarditis, although low, increased after the receipt of the BNT162b2 vaccine, particularly after the second dose among young male recipients. The clinical presentation of myocarditis after vaccination was usually mild.

Author/s:

Mevorach, D., Anis, E., Cedar, N., Bromberg, M., Haas, E. J., Nadir, E., Olsha-Castell, S., Arad, D., Hasin, T., Levi, N., Asleh, R., Amir, O., Meir, K., Cohen, D., Dichtiar, R., Novick, D., Hershkovitz, Y., Dagan, R., Leitersdorf, I., Ben-Ami, R., Miskin, I., Saliba, W., Muhsen, K., Levi, Y., Green, M. S., Beinan-Boker, L., Alroy-Preis, S.

Maintenance or Discontinuation of Antidepressants in Primary Care

Bethie Seay — Sun, 03 Oct 2021 05:00:00 +0000

Date Added:

October 3, 2021

Journal/Publication:

The New England Journal of Medicine

Publication Date:

September 30, 2021

Type:

Clinical Research Results

DOI (1):

10.1056/NEJMoa2106356

In patients whose depression resolved on antidepressants, discontinuation of the antidepressant is associated with a significantly higher rate of depression reoccurrence vs. maintenance antidepressant therapy over a one year period.

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BACKGROUND
Patients with depression who are treated in primary care practices may receive antidepressants for prolonged periods. Data are limited on the effects of maintaining or discontinuing antidepressant therapy in this setting.

METHODS
We conducted a randomized, double-blind trial involving adults who were being treated in 150 general practices in the United Kingdom. All the patients had a history of at least two depressive episodes or had been taking antidepressants for 2 years or longer and felt well enough to consider stopping antidepressants. Patients who had received citalopram, fluoxetine, sertraline, or mirtazapine were randomly assigned in a 1:1 ratio to maintain their current antidepressant therapy (maintenance group) or to taper and discontinue such therapy with the use of matching placebo (discontinuation group). The primary outcome was the first relapse of depression during the 52-week trial period, as evaluated in a time-to-event analysis. Secondary outcomes were depressive and anxiety symptoms, physical and withdrawal symptoms, quality of life, time to stopping an antidepressant or placebo, and global mood ratings.

RESULTS
A total of 1466 patients underwent screening. Of these patients, 478 were enrolled in the trial (238 in the maintenance group and 240 in the discontinuation group). The average age of the patients was 54 years; 73% were women. Adherence to the trial assignment was 70% in the maintenance group and 52% in the discontinuation group. By 52 weeks, relapse occurred in 92 of 238 patients (39%) in the maintenance group and in 135 of 240 (56%) in the discontinuation group (hazard ratio, 2.06; 95% confidence interval, 1.56 to 2.70; P<0.001). Secondary outcomes were generally in the same direction as the primary outcome. Patients in the discontinuation group had more symptoms of depression, anxiety, and withdrawal than those in the maintenance group.

CONCLUSIONS
Among patients in primary care practices who felt well enough to discontinue antidepressant therapy, those who were assigned to stop their medication had a higher risk of relapse of depression by 52 weeks than those who were assigned to maintain their current therapy. (Funded by the National Institute for Health Research; ANTLER ISRCTN number, ISRCTN15969819.)

Author/s:

Lewis, G., Marston, L., Duffy, L., Freemantle, N., Gilbody, S., Hunter, R., Kendrick, T., Kessler, D., Mangin, D., King, M., Lanham, P., Moore, M.

Recombinant Zoster Vaccine (Shingrix): Real-World Effectiveness in the First 2 Years Post-Licensure

Bethie Seay — Thu, 23 Sep 2021 05:00:00 +0000

Date Added:

September 23, 2021

Journal/Publication:

Clinical Infectious Diseases

Publication Date:

September 15, 2021

Issue:

Volume:

Pages:

941-948

Type:

Clinical Research Results

DOI (1):

10.1093/cid/ciab125

MeSH

herpes zoster vaccine

Neuralgia, Postherpetic

Real world effectiveness of Shingrix (76%)

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Background
Shingrix (recombinant zoster vaccine) was licensed to prevent herpes zoster, dispensed as 2 doses given 2–6 months apart among adults aged ≥50 years. Clinical trials yielded efficacy of >90% for confirmed herpes zoster, but post-market performance has not been evaluated. Efficacy of a single dose and a delayed second dose and efficacy among persons with autoimmune or immunosuppressive conditions have not been studied. We aimed to assess post-market vaccine effectiveness of Shingrix.

Methods
We conducted a cohort study among Medicare Part D community-dwelling beneficiaries aged >65 years. Herpes zoster was identified using a medical office visit diagnosis with treatment, and postherpetic neuralgia was identified using a validated algorithm. We used inverse probability of treatment weighting to improve cohort balance and marginal structural models to estimate hazard ratios.

Results
We found a vaccine effectiveness of 70.1% (95% confidence interval [CI], 68.6–71.5) and 56.9% (95% CI, 55.0–58.8) for 2 and 1 doses, respectively. The 2-dose vaccine effectiveness was not significantly lower for beneficiaries aged >80 years, for second doses received at ≥180 days, or for individuals with autoimmune conditions. The vaccine was also effective among individuals with immunosuppressive conditions. Two-dose vaccine effectiveness against postherpetic neuralgia was 76.0% (95% CI, 68.4–81.8).

Conclusions
This large real-world observational study of the effectiveness of Shingrix demonstrates the benefit of completing the 2-dose regimen. Second doses administered beyond the recommended 6 months did not impair effectiveness. Our effectiveness estimates were lower than the clinical trials estimates, likely due to differences in outcome specificity.

Author/s:

Izurieta, H. S., Wu, X., Forshee, R., Lu, Y., Sung, H. M., Agger, P. E., Chillarige, Y., Link-Gelles, R., Lufkin, B., Wernecke, M., MaCurdy, T. E., Kelman, J., Dooling, K.

Colchicine in Patients with Chronic Coronary Disease

Brian Desmarais — Sat, 07 Nov 2020 22:20:46 +0000

Date Added:

November 7, 2020

Journal/Publication:

New England Journal of Medicine

Publication Date:

November 5, 2020

URL:

Colchicine in Patients with Chronic Coronary Disease

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMoa2021372

MeSH

Heart Diseases

Myocardial Ischemia

coronary artery disease

myocardial infarction

In this RCT involving patients with chronic coronary artery disease, 0.5mg of colchicine daily reduce the risk of a composite endpoint of cardiovascular death, myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization. James W. Mold, MD, MPH

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Abstract

Background: Evidence from a recent trial has shown that the antiinflammatory effects of colchicine reduce the risk of cardiovascular events in patients with recent myocardial infarction, but evidence of such a risk reduction in patients with chronic coronary disease is limited.

Methods: In a randomized, controlled, double-blind trial, we assigned patients with chronic coronary disease to receive 0.5 mg of colchicine once daily or matching placebo. The primary end point was a composite of cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization. The key secondary end point was a composite of cardiovascular death, spontaneous myocardial infarction, or ischemic stroke.

Results: A total of 5522 patients underwent randomization; 2762 were assigned to the colchicine group and 2760 to the placebo group. The median duration of follow-up was 28.6 months. A primary end-point event occurred in 187 patients (6.8%) in the colchicine group and in 264 patients (9.6%) in the placebo group (incidence, 2.5 vs. 3.6 events per 100 person-years; hazard ratio, 0.69; 95% confidence interval [CI], 0.57 to 0.83; P<0.001). A key secondary end-point event occurred in 115 patients (4.2%) in the colchicine group and in 157 patients (5.7%) in the placebo group (incidence, 1.5 vs. 2.1 events per 100 person-years; hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P = 0.007). The incidence rates of spontaneous myocardial infarction or ischemia-driven coronary revascularization (composite end point), cardiovascular death or spontaneous myocardial infarction (composite end point), ischemia-driven coronary revascularization, and spontaneous myocardial infarction were also significantly lower with colchicine than with placebo. The incidence of death from noncardiovascular causes was higher in the colchicine group than in the placebo group (incidence, 0.7 vs. 0.5 events per 100 person-years; hazard ratio, 1.51; 95% CI, 0.99 to 2.31).

Conclusions: In a randomized trial involving patients with chronic coronary disease, the risk of cardiovascular events was significantly lower among those who received 0.5 mg of colchicine once daily than among those who received placebo. (Funded by the National Health Medical Research Council of Australia and others; LoDoCo2 Australian New Zealand Clinical Trials Registry number, ACTRN12614000093684.).

Author/s:

LoDoCo2 Trial Investigators

Reduction in Saturated Fat Intake for Cardiovascular Disease

Brian Desmarais — Fri, 12 Jun 2020 19:42:30 +0000

Date Added:

June 12, 2020

Journal/Publication:

The Cochrane Database of Systematic Reviews

Publication Date:

May 19, 2020

URL:

Reduction in Saturated Fat Intake for Cardiovascular Disease

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1002/14651858.CD011737.pub2.

MeSH

cardiovascular diseases

6-dimethylaminodibenzopyriodonium citrate

body mass index

Dietary replacement of saturated fatty acids with polyunsaturated fatty acids or carbohydrates for at least 2 years, appears to reduce the incidence of adverse cardiovascular events. James W. Mold, MD, MPH

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Abstract

Background: Reducing saturated fat reduces serum cholesterol, but effects on other intermediate outcomes may be less clear. Additionally, it is unclear whether the energy from saturated fats eliminated from the diet are more helpfully replaced by polyunsaturated fats, monounsaturated fats, carbohydrate or protein.

Objectives: To assess the effect of reducing saturated fat intake and replacing it with carbohydrate (CHO), polyunsaturated (PUFA), monounsaturated fat (MUFA) and/or protein on mortality and cardiovascular morbidity, using all available randomised clinical trials.

Search methods: We updated our searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid) and Embase (Ovid) on 15 October 2019, and searched Clinicaltrials.gov and WHO International Clinical Trials Registry Platform (ICTRP) on 17 October 2019.

Selection criteria: Included trials fulfilled the following criteria: 1) randomised; 2) intention to reduce saturated fat intake OR intention to alter dietary fats and achieving a reduction in saturated fat; 3) compared with higher saturated fat intake or usual diet; 4) not multifactorial; 5) in adult humans with or without cardiovascular disease (but not acutely ill, pregnant or breastfeeding); 6) intervention duration at least 24 months; 7) mortality or cardiovascular morbidity data available.

Data collection and analysis: Two review authors independently assessed inclusion, extracted study data and assessed risk of bias. We performed random-effects meta-analyses, meta-regression, subgrouping, sensitivity analyses, funnel plots and GRADE assessment.

Main results: We included 15 randomised controlled trials (RCTs) (16 comparisons, ~59,000 participants), that used a variety of interventions from providing all food to advice on reducing saturated fat. The included long-term trials suggested that reducing dietary saturated fat reduced the risk of combined cardiovascular events by 21% (risk ratio (RR) 0.79; 95% confidence interval (CI) 0.66 to 0.93, 11 trials, 53,300 participants of whom 8% had a cardiovascular event, I² = 65%, GRADE moderate-quality evidence). Meta-regression suggested that greater reductions in saturated fat (reflected in greater reductions in serum cholesterol) resulted in greater reductions in risk of CVD events, explaining most heterogeneity between trials. The number needed to treat for an additional beneficial outcome (NNTB) was 56 in primary prevention trials, so 56 people need to reduce their saturated fat intake for ~four years for one person to avoid experiencing a CVD event. In secondary prevention trials, the NNTB was 32. Subgrouping did not suggest significant differences between replacement of saturated fat calories with polyunsaturated fat or carbohydrate, and data on replacement with monounsaturated fat and protein was very limited. We found little or no effect of reducing saturated fat on all-cause mortality (RR 0.96; 95% CI 0.90 to 1.03; 11 trials, 55,858 participants) or cardiovascular mortality (RR 0.95; 95% CI 0.80 to 1.12, 10 trials, 53,421 participants), both with GRADE moderate-quality evidence. There was little or no effect of reducing saturated fats on non-fatal myocardial infarction (RR 0.97, 95% CI 0.87 to 1.07) or CHD mortality (RR 0.97, 95% CI 0.82 to 1.16, both low-quality evidence), but effects on total (fatal or non-fatal) myocardial infarction, stroke and CHD events (fatal or non-fatal) were all unclear as the evidence was of very low quality. There was little or no effect on cancer mortality, cancer diagnoses, diabetes diagnosis, HDL cholesterol, serum triglycerides or blood pressure, and small reductions in weight, serum total cholesterol, LDL cholesterol and BMI. There was no evidence of harmful effects of reducing saturated fat intakes.

Authors' conclusions: The findings of this updated review suggest that reducing saturated fat intake for at least two years causes a potentially important reduction in combined cardiovascular events. Replacing the energy from saturated fat with polyunsaturated fat or carbohydrate appear to be useful strategies, while effects of replacement with monounsaturated fat are unclear. The reduction in combined cardiovascular events resulting from reducing saturated fat did not alter by study duration, sex or baseline level of cardiovascular risk, but greater reduction in saturated fat caused greater reductions in cardiovascular events.

Trial registration: ClinicalTrials.gov NCT00000611 NCT02062424 NCT00692536 NCT01954472 NCT01005498 NCT01634841 NCT03354377.

Author/s:

Hopper, L., Martin, N., Jimoh, O.F., Kirk, C., Foster, E., Abdelhamid, A.

Handgun Ownership and Suicide in California

Brian Desmarais — Thu, 04 Jun 2020 19:59:09 +0000

Date Added:

June 4, 2020

Journal/Publication:

New England Journal of Medicine

Publication Date:

June 4, 2020

Volume:

382

Pages:

2220-2229

URL:

Handgun Ownership and Suicide in California

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMsa1916744

Keywords

MeSH

Proportional Hazards Models

Ethnic Groups

I know it isn’t always easy to inquire about gun ownership in Oklahoma. However, if the goal is to prevent premature death, you should certainly ask patients who are depressed. James W. Mold, MD, MPH

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BACKGROUND

Research has consistently identified firearm availability as a risk factor for suicide. However, existing studies are relatively small in scale, estimates vary widely, and no study appears to have tracked risks from commencement of firearm ownership.

METHODS

We identified handgun acquisitions and deaths in a cohort of 26.3 million male and female residents of California, 21 years old or older, who had not previously acquired handguns. Cohort members were followed for up to 12 years 2 months (from October 18, 2004, to December 31, 2016). We used survival analysis to estimate the relationship between handgun ownership and both all-cause mortality and suicide (by firearm and by other methods) among men and women. The analysis allowed the baseline hazard to vary according to neighborhood and was adjusted for age, race and ethnic group, and ownership of long guns (i.e., rifles or shotguns).

RESULTS

A total of 676,425 cohort members acquired one or more handguns, and 1,457,981 died; 17,894 died by suicide, of which 6691 were suicides by firearm. Rates of suicide by any method were higher among handgun owners, with an adjusted hazard ratio of 3.34 for all male owners as compared with male nonowners (95% confidence interval [CI], 3.13 to 3.56) and 7.16 for female owners as compared with female nonowners (95% CI, 6.22 to 8.24). These rates were driven by much higher rates of suicide by firearm among both male and female handgun owners, with a hazard ratio of 7.82 for men (95% CI, 7.26 to 8.43) and 35.15 for women (95% CI, 29.56 to 41.79). Handgun owners did not have higher rates of suicide by other methods or higher all-cause mortality. The risk of suicide by firearm among handgun owners peaked immediately after the first acquisition, but 52% of all suicides by firearm among handgun owners occurred more than 1 year after acquisition.

CONCLUSIONS

Handgun ownership is associated with a greatly elevated and enduring risk of suicide by firearm. (Funded by the Fund for a Safer Future and others.)

Author/s:

Studdert, D.M., Zhang, Y., Swanson, S.A., Prince, L., Rodden J.A., Holsinger, E.E., Wintemute, G.J., Miller, M., Spittal, M.J.