treatment outcome

In this large, randomized trial, initial referral to surgery in carpal tunnel syndrome led to better results at 18 months than initial corticosteroid injection. James W. Mold, MD, MPH

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Background: Surgery and corticosteroid injections are established treatments for carpal tunnel syndrome, but the optimal treatment strategy remains unclear. This study aimed to compare starting treatment with surgery versus starting with a corticosteroid injection.

Methods: We conducted an open-label, randomised controlled trial across 31 hospitals in the Netherlands. Eligible patients, diagnosed with carpal tunnel syndrome for at least 6 weeks and confirmed by electrophysiological or sonographic testing, were randomly assigned (1:1) to start treatment with either surgery or an injection via a web-based system. Randomisation was stratified by unilateral or bilateral symptoms, carpal tunnel syndrome with or without concomitant disease as risk factor, and previous ipsilateral injections. If needed, additional treatments were allowed, such as additional injections or surgery. The primary outcome, assessed in the intention-to-treat population, was the proportion of patients who were recovered (defined as a score of less than eight points on the six-item carpal tunnel syndrome scale) at 18 months. The trial was preregistered with the ISRCTN Registry (ISRCTN13164336) and is now completed.

Findings: From Nov 7, 2017, to Nov 4, 2021, 934 participants (545 female and 389 male participants) were included. 468 were randomised to the surgery group and 466 to the injection group. At 18 months, 805 (86%) of 934 participants had primary outcome data. In the surgery group, 243 (61%) of 401 participants had recovered, significantly higher than the 180 (45%) of 404 participants recovered in the injection group (relative risk 1·36; 95% CI 1·19-1·56; p<0·0001). One or more adverse event occurred in 376 (86%) of 436 participants in the surgery group and in 384 (85%) of 453 participants in the injection group. One participant in the surgery group was hospitalised due to complications. No treatment-related deaths were reported.

Interpretation: In patients with carpal tunnel syndrome, initiating treatment with surgery offers a higher chance of recovery after 18 months compared with starting with a corticosteroid injection, even with the possibility of additional interventions.

Funding: The Netherlands Organization for Health Research and Development and Zorgverzekeraars Nederland.

Author/s:

Wijnand A C Palmbergen, Roy Beekman, A Marijne Heeren, Bart F L van Nuenen, Tim W H Alleman, Esther Verstraete, Korné Jellema, Wim I M Verhagen, Leo H Visser, Godard C W de Ruiter, Diederik van de Beek, Corianne A J M de Borgie, Johannes A Bogaards, Rob M A de Bie, Camiel Verhamme, Dutch CTS study group

Is acupuncture an effective treatment for temporomandibular disorder?: A systematic review and meta-analysis of randomized controlled trials

Rowan Hutchins — Wed, 04 Oct 2023 05:00:00 +0000

Date Added:

October 4, 2023

Journal/Publication:

Medicine

Publication Date:

September 22, 2023

Issue:

Volume:

102

URL:

Is acupuncture an effective treatment for temporomandibular disorder?: A systematic review and meta-analysis of randomized controlled trials

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1097/MD.0000000000034950

Keywords

Acupuncture

PMID (1):

37746950

MeSH

Acupuncture Therapy*

Randomized Controlled Trials as Topic

Temporomandibular Joint Disorders* / therapy

treatment outcome

Acupuncture appears to be pretty effective for reducing the discomfort associated with conditions involving the TM joint and its associated muscles. James W. Mold, MD, MPH

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Background:
Acupuncture is used for treating various disorders, but its effects on temporomandibular disorder (TMD) remain unclear. This study aimed to assess the effectiveness and safety of acupuncture for TMD via a systematic review of randomized clinical trials.

Methods:
A total of 11 Korean and worldwide databases were searched to identify acupuncture studies in adults with TMD. A Cochrane risk of bias assessment was performed on all articles; a meta-analysis, which involved the categorization according to the type of control used (inactive control, active control, or add-on), was subsequently performed. The quality of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation methodology.

Results:
The qualitative analysis of randomized clinical trials with acupuncture as the intervention included 32 articles, 22 of which were included in the quantitative analysis (471 participants). Acupuncture significantly improved outcomes (effect rate, relative risk [RR]: 7.00, 95% confidence interval [CI]: 1.91, 25, 62; visual analog scale, standardized mean difference: 0.49, 95% CI: 0.24, 0.73) versus active controls (effect rate, RR: 1.19; 95% CI: 1.12, 1.27). In the analysis of add-ons, acupuncture significantly improved the effect rate and pain intensity (effect rate, RR: 1.36; 95% CI: 1.04, 1.77; visual analog scale, mean difference: −1.23; 95% CI −1.79, −0.67). However, the quality of evidence was determined to range from low to very low.

Conclusion:
Acupuncture in TMD significantly improved outcomes versus active controls and when add-on treatments were applied. However, as the quality of evidence was determined to be low, well-designed clinical trials should be conducted in the future.

Author/s:

Park, Eun Young, Cho, Jae-Heung, Lee, Sook-Hyun, Kim, Koh-Woon, Ha, In-Hyuk, Lee, Yoon Jae

Normal pressure hydrocephalus treated with ventriculoperitoneal shunt

Aubrey Delammermore — Sat, 28 Jan 2023 06:00:00 +0000

Date Added:

January 28, 2023

Journal/Publication:

CMAJ

Publisher:

CMA Impact

Publication Date:

January 23, 2023

Issue:

Volume:

195

Pages:

E115-E119

URL:

Normal pressure hydrocephalus treated with ventriculoperitoneal shunt

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1503/cmaj.221027

Keywords

ventriculoperitoneal shunt

PMID (1):

36690362

MeSH

Hydrocephalus* / surgery

Hydrocephalus, Normal Pressure*

retrospective studies

treatment outcome

ventriculoperitoneal shunt

A concise review of what we know about normal pressure hydrocephalus. James W. Mold, MD, MPH

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Normal pressure hydrocephalus is a form of adult hydrocephalus with ventriculomegaly in the absence of any structural blockage of the cerebrospinal fluid circulation.

Normal pressure hydrocephalus is a partially reversible cause of dementia, manifesting with a triad of cognitive impairment, gait disturbance and urinary incontinence.

A detailed cognitive assessment, neurologic examination and brain imaging is necessary to exclude alternative causes and confirm the diagnosis.

High-volume lumbar puncture with pre- and postprocedure gait assessment is recommended as a confirmatory test before a decision is made regarding therapeutic interventions such as shunting.

Author/s:

Fereshtehnejad, S., Nicholls, M., Huang, S., Akter, R.

Pharmacologic and Nonpharmacologic Treatments for Posttraumatic Stress Disorder

Aubrey Delammermore — Sun, 06 Nov 2022 05:00:00 +0000

Date Added:

November 6, 2022

Publisher:

Agency for Healthcare Research and Quality

Publication Date:

October 24, 2022

URL:

Pharmacologic and Nonpharmacologic Treatments for Posttraumatic Stress Disorder

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.23970/AHRQEPCPTSD2022

Keywords

PTSD

Sample Size

Health Policy

referral and consultation

MEDLINE

PMID (1):

33252890

MeSH

stress disorders, post-traumatic

An evidence-based review of our current knowledge of both pharmacologic and non-pharmacologic treatments for people suffering from PTSD. James W. Mold, MD, MPH

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Objectives: Identify and abstract data from posttraumatic stress disorder (PTSD) treatment randomized controlled trials (RCTs) to update the PTSD Trials Standardized Data Repository (PTSD-Repository) with data on PTSD and mental health, including suicide-related outcomes and substance use.

Data sources: We searched PTSDpubs, Ovid® MEDLINE®, Cochrane CENTRAL, PsycINFO®, Embase®, CINAHL®, and Scopus® for eligible RCTs published from 1980 to May 22, 2020.

Review methods: In consultation with the National Center for PTSD (NCPTSD), we updated the PTSD-Repository by expanding inclusion criteria to RCTs targeting comorbid PTSD/substance use disorder (SUD) and adding data elements. The primary publication for each RCT was abstracted; data and citations from secondary publications (i.e., companion papers) appear in the same record. We assessed risk of bias (ROB) for all studies in the PTSD-Repository. We undertook an exploratory assessment of an expanded ROB system developed with guidance from a Technical Expert Panel and NCPTSD, which was pilot tested on a small subset of studies.

Results: We identified 47 new RCTs of interventions for PTSD and 21 RCTs for comorbid PTSD/SUD, resulting in 389 included studies published from 1988 to 2020. Psychotherapy interventions were the most common (63%), followed by pharmacologic interventions (25%). Most studies were conducted in the United States (62%) and had sample sizes ranging from 25 to 99 participants (60%). Approximately half of studies enrolled community participants (55%), and most were conducted in the outpatient setting (72%). Studies typically enrolled participants with a mix of trauma types (53%). Most RCTs (60%) were rated as having a medium ROB, and only 6 percent were rated as having a low ROB. Our pilot testing of an expanded ROB assessment tool emphasized more detailed assessment of elements, including: (1) methods for managing missing data, including both dropout from treatment and missing measurements (i.e., loss to followup); (2) differential assessment of subjective and objective outcomes; and (3) consideration of a five-category overall rating system.

Conclusions: The PTSD-Repository is a comprehensive database of data from PTSD trials. The PTSD-Repository allows clinical, research, education, and policy stakeholders to understand current research on treatment effectiveness and harms, and enable informed decisions about future research, mental health policy, and clinical care priorities. This report updates the studies and variables included in the PTSD-Repository to include recently published trials, interventions targeting comorbid PTSD/SUD, variables related to comorbidities such as suicide and SUDs, and ROB assessment.

Author/s:

O'Neil, M. E., Cheney, T. P., Hsu, F. C., Carlson, K. F., Hart, E. L., Holmes, R. S., Murphy, K. M., Graham, E., Cameron, D. C., Kahler, J., Lewis, M., Kaplan, J., McDonagh, M. S.

Evidence-Based Guideline: Treatment of Convulsive Status Epilepticus in Children and Adults: Report of the Guideline Committee of the American Epilepsy Society

Bethie Seay — Tue, 30 Nov 2021 06:00:00 +0000

Date Added:

November 30, 2021

Journal/Publication:

Epilepsy Currents

Publication Date:

January 1, 2016

Issue:

Volume:

Pages:

48-61

Type:

Meta-analyses, Reviews, and Guidelines

DOI (1):

10.5698/1535-7597-16.1.48

PMID (1):

26900382

MeSH

Respiratory Insufficiency

Algorithms

Randomized Controlled Trials as Topic

I thought I would place this guideline for treatment of status epilepticus in the RPR library as a reference. It might also be worth posting the recommended doses and routes of administration of the recommended benzos and assuring that one of them is available if needed.

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CONTEXT: The optimal pharmacologic treatment for early convulsive status epilepticus is unclear. OBJECTIVE: To analyze efficacy, tolerability and safety data for anticonvulsant treatment of children and adults with convulsive status epilepticus and use this analysis to develop an evidence-based treatment algorithm. DATA SOURCES: Structured literature review using MEDLINE, Embase, Current Contents, and Cochrane library supplemented with article reference lists. STUDY SELECTION: Randomized controlled trials of anticonvulsant treatment for seizures lasting longer than 5 minutes. DATA EXTRACTION: Individual studies were rated using predefined criteria and these results were used to form recommendations, conclusions, and an evidence-based treatment algorithm. RESULTS: A total of 38 randomized controlled trials were identified, rated and contributed to the assessment. Only four trials were considered to have class I evidence of efficacy. Two studies were rated as class II and the remaining 32 were judged to have class III evidence. In adults with convulsive status epilepticus, intramuscular midazolam, intravenous lorazepam, intravenous diazepam and intravenous phenobarbital are established as efficacious as initial therapy (Level A). Intramuscular midazolam has superior effectiveness compared to intravenous lorazepam in adults with convulsive status epilepticus without established intravenous access (Level A). In children, intravenous lorazepam and intravenous diazepam are established as efficacious at stopping seizures lasting at least 5 minutes (Level A) while rectal diazepam, intramuscular midazolam, intranasal midazolam, and buccal midazolam are probably effective (Level B). No significant difference in effectiveness has been demonstrated between intravenous lorazepam and intravenous diazepam in adults or children with convulsive status epilepticus (Level A). Respiratory and cardiac symptoms are the most commonly encountered treatment-emergent adverse events associated with intravenous anticonvulsant drug administration in adults with convulsive status epilepticus (Level A). The rate of respiratory depression in patients with convulsive status epilepticus treated with benzodiazepines is lower than in patients with convulsive status epilepticus treated with placebo indicating that respiratory problems are an important consequence of untreated convulsive status epilepticus (Level A). When both are available, fosphenytoin is preferred over phenytoin based on tolerability but phenytoin is an acceptable alternative (Level A). In adults, compared to the first therapy, the second therapy is less effective while the third therapy is substantially less effective (Level A). In children, the second therapy appears less effective and there are no data about third therapy efficacy (Level C). The evidence was synthesized into a treatment algorithm. CONCLUSIONS: Despite the paucity of well-designed randomized controlled trials, practical conclusions and an integrated treatment algorithm for the treatment of convulsive status epilepticus across the age spectrum (infants through adults) can be constructed. Multicenter, multinational efforts are needed to design, conduct and analyze additional randomized controlled trials that can answer the many outstanding clinically relevant questions identified in this guideline.

Author/s:

Glauser, T., Shinnar, S., Gloss, D., Alldredge, B., Arya, R., Bainbridge, J., Bare, M., Bleck, T., Dodson, W. E., Garrity, L., Jagoda, A., Lowenstein, D., Pellock, J., Riviello, J., Sloan, E., Treiman, D. M.

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.

Managing Asthma in Adolescents and Adults 2020 Asthma Guideline Update From the National Asthma Education and Prevention Program

Brian Desmarais — Mon, 14 Dec 2020 15:03:27 +0000

Date Added:

December 14, 2020

Journal/Publication:

JAMA Network

Publication Date:

December 3, 2020

Issue:

Volume:

323

URL:

Managing Asthma in Adolescents and Adults 2020 Asthma Guideline Update From the National Asthma Education and Prevention Program

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

doi:10.1001/jama.2020.21974

Keywords

asthma treatment

MeSH

treatment outcome

asthma

A summary of six significant changes and updates to the NHLBI Asthma Guidelines for adolescents and adults. James W. Mold, MD, MPH

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Importance Asthma is a major public health problem worldwide and is associated with excess morbidity, mortality, and economic costs associated with lost productivity. The National Asthma Education and Prevention Program has released the 2020 Asthma Guideline Update with updated evidence-based recommendations for treatment of patients with asthma.

Objective To report updated recommendations for 6 topics for clinical management of adolescents and adults with asthma: (1) intermittent inhaled corticosteroids (ICSs); (2) add-on long-acting muscarinic antagonists; (3) fractional exhaled nitric oxide; (4) indoor allergen mitigation; (5) immunotherapy; and (6) bronchial thermoplasty.

Evidence Review The National Heart, Lung, and Blood Advisory Council chose 6 topics to update the 2007 asthma guidelines based on results from a 2014 needs assessment. The Agency for Healthcare Research and Quality conducted systematic reviews of these 6 topics based on literature searches up to March-April 2017. Reviews were updated through October 2018 and used by an expert panel (n = 19) that included asthma content experts, primary care clinicians, dissemination and implementation experts, and health policy experts to develop 19 new recommendations using the GRADE method. The 17 recommendations for individuals aged 12 years or older are reported in this Special Communication.

Findings From 20 572 identified references, 475 were included in the 6 systematic reviews to form the evidence basis for these recommendations. Compared with the 2007 guideline, there was no recommended change in step 1 (intermittent asthma) therapy (as-needed short-acting β2-agonists [SABAs] for rescue therapy). In step 2 (mild persistent asthma), either daily low-dose ICS plus as-needed SABA therapy or as-needed concomitant ICS and SABA therapy are recommended. Formoterol in combination with an ICS in a single inhaler (single maintenance and reliever therapy) is recommended as the preferred therapy for moderate persistent asthma in step 3 (low-dose ICS-formoterol therapy) and step 4 (medium-dose ICS-formoterol therapy) for both daily and as-needed therapy. A short-term increase in the ICS dose alone for worsening of asthma symptoms is not recommended. Add-on long-acting muscarinic antagonists are recommended in individuals whose asthma is not controlled by ICS-formoterol therapy for step 5 (moderate-severe persistent asthma). Fractional exhaled nitric oxide testing is recommended to assist in diagnosis and monitoring of symptoms, but not alone to diagnose or monitor asthma. Allergen mitigation is recommended only in individuals with exposure and relevant sensitivity or symptoms. When used, allergen mitigation should be allergen specific and include multiple allergen-specific mitigation strategies. Subcutaneous immunotherapy is recommended as an adjunct to standard pharmacotherapy for individuals with symptoms and sensitization to specific allergens. Sublingual immunotherapy is not recommended specifically for asthma. Bronchial thermoplasty is not recommended as part of standard care; if used, it should be part of an ongoing research effort.

Conclusions and Relevance Asthma is a common disease with substantial human and economic costs globally. Although there is no cure or established means of prevention, effective treatment is available. Use of the recommendations in the 2020 Asthma Guideline Update should improve the health of individuals with asthma.

Author/s:

Cloutier, M.M., Dixon, A.E., Krishnan, J.A.

Pharmacologic and Nonpharmacologic Treatments for Posttraumatic Stress Disorder: An Update of the PTSD-Repository Evidence Base

Brian Desmarais — Mon, 09 Nov 2020 20:14:11 +0000

Date Added:

November 9, 2020

Journal/Publication:

Agency for Healthcare Research and Quality

Publisher:

U.S Department of Health & Human Services

Publication Date:

November 4, 2020

URL:

Pharmacologic and Nonpharmacologic Treatments for Posttraumatic Stress Disorder: An Update of the PTSD-Repository Evidence Base

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.23970/AHRQEPCCER235

Keywords

PTSD

MeSH

stress disorders, post-traumatic

23-valent pneumococcal capsular polysaccharide vaccine

An AHRQ evidence report on the treatment of PTSD, both pharmacologic and non-pharmacologic. James W. Mold,. MD, MPH

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Structured Abstract

Objectives. Identify and abstract data from posttraumatic stress disorder (PTSD) treatment randomized controlled trials (RCTs) to update the PTSD Trials Standardized Data Repository (PTSD-Repository) with data on PTSD and mental health, including suicide-related outcomes and substance use.

Data sources. We searched PTSDpubs, Ovid® MEDLINE®, Cochrane CENTRAL, PsycINFO®, Embase®, CINAHL®, and Scopus® for eligible RCTs published from 1980 to May 22, 2020.

Review methods. In consultation with the National Center for PTSD (NCPTSD), we updated the PTSD-Repository by expanding inclusion criteria to RCTs targeting comorbid PTSD/substance use disorder (SUD) and adding data elements. The primary publication for each RCT was abstracted; data and citations from secondary publications (i.e., companion papers) appear in the same record. We assessed risk of bias (ROB) for all studies in the PTSD-Repository. We undertook an exploratory assessment of an expanded ROB system developed with guidance from a Technical Expert Panel and NCPTSD, which was pilot tested on a small subset of studies.

Results. We identified 47 new RCTs of interventions for PTSD and 21 RCTs for comorbid PTSD/SUD, resulting in 389 included studies published from 1988 to 2020. Psychotherapy interventions were the most common (63%), followed by pharmacologic interventions (25%). Most studies were conducted in the United States (62%) and had sample sizes ranging from 25 to 99 participants (60%). Approximately half of studies enrolled community participants (55%), and most were conducted in the outpatient setting (72%). Studies typically enrolled participants with a mix of trauma types (53%). Most RCTs (60%) were rated as having a medium ROB, and only 6 percent were rated as having a low ROB. Our pilot testing of an expanded ROB assessment tool emphasized more detailed assessment of elements, including: (1) methods for managing missing data, including both dropout from treatment and missing measurements (i.e., loss to followup); (2) differential assessment of subjective and objective outcomes; and (3) consideration of a five-category overall rating system.

Conclusions. The PTSD-Repository is a comprehensive database of data from PTSD trials. The PTSD-Repository allows clinical, research, education, and policy stakeholders to understand current research on treatment effectiveness and harms, and enable informed decisions about future research, mental health policy, and clinical care priorities. This report updates the studies and variables included in the PTSD-Repository to include recently published trials, interventions targeting comorbid PTSD/SUD, variables related to comorbidities such as suicide and SUDs, and ROB assessment.

Author/s:

Agency for Healthcare Research and Quality

Diagnosis and Treatment of Clinical Alzheimer’s-Type Dementia

Brian Desmarais — Fri, 01 May 2020 15:44:37 +0000

Date Added:

May 1, 2020

Journal/Publication:

Comparative Effectiveness Review

Publisher:

Agency for Healthcare Research and Quality

Publication Date:

April 20, 2020

URL:

Diagnosis and Treatment of Clinical Alzheimer’s-Type Dementia

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

https://doi.org/10.23970/AHRQEPCCER223

Keywords

cognitive screening tests

alzheimer's disease

treatment

MeSH

Cholinesterase Inhibitors

A review of the evidence regarding cognitive screening tests used to “diagnose” (identify patients with cognitive impairment that could be Alzheimer’s Disease) and the (lack of) effectiveness of currently available medications use to treat it. James W. Mold, MD, MPH

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Objective. To summarize evidence on: (1) the accuracy of brief cognitive tests for identifying clinical Alzheimer’s-type dementia (CATD) in individuals with suspected cognitive impairment; (2) the accuracy of biomarkers for identifying Alzheimer’s disease (AD) in individuals with dementia; and (3) the benefits and harms of prescription drugs and supplements for cognition, function, and behavioral and psychological symptoms of dementia (BPSD) in patients with CATD.

Data sources. Electronic bibliographic databases to March 2019, ClinicalTrials.gov, systematic review bibliographies.

Review methods. Cognitive test accuracy studies must have used explicit CATD diagnostic criteria and a non-CATD control group. Biomarker accuracy studies must have used neuropathologic criteria to define AD cases and non-AD controls. All treatment trials must have enrolled participants with CATD; those evaluating BPSD enrolled individuals with CATD and BPSD. Minimum trial duration was 2 weeks for agitation, aggression, psychosis, and disinhibited sexual behavior, and 24 weeks for other outcomes. Two reviewers rated risk of bias (ROB) and strength of evidence. One reviewer extracted data; a second checked accuracy. We analyzed English-language studies with low or medium ROB.

Results. We analyzed 56 unique studies on the accuracy of brief cognitive tests for CATD, 24 on accuracy of biomarkers for AD (15 brain imaging, nine cerebrospinal fluid [CSF] testing), and 67 trials of CATD treatment (54 reporting cognition or function, 13 reporting BPSD). Multiple brief cognitive tests were highly sensitive and specific (>0.8) for distinguishing CATD from normal cognition, but less so for distinguishing mild CATD from normal cognition or CATD from mild cognitive impairment (MCI). Based on few studies, compared with clinical evaluation alone, amyloid positron emission tomography (PET), fluorodeoxyglucose (FDG)-PET, and combinations of CSF tests added to clinical evaluation may improve accuracy for distinguishing AD from non-AD dementia. Regardless of CATD severity, cholinesterase-inhibitors produced small improvements in cognition and function compared with placebo but may increase serious adverse events and withdrawals due to adverse events. For moderate to severe CATD, memantine plus a cholinesterase inhibitor slightly improved global change and inconsistently improved cognition, but not function, compared with a cholinesterase inhibitor alone. Evidence was mostly insufficient about the effects of prescription drugs and supplements on agitation, aggression, psychosis, or disinhibited sexual behavior.

Conclusion. Brief cognitive tests accurately distinguished CATD from normal cognition, but were less accurate distinguishing smaller clinical differences. Whether biomarkers improve diagnostic accuracy when added to clinical evaluation needs further verification, but potential benefits of testing are limited by lack of effective treatments for AD and non-AD dementias. Cholinesterase-inhibitors slightly outperformed placebo for cognition and function, but evidence of whether any drug treatments improved BPSD was largely insufficient.

Author/s:

Hemmy, L.S, Fink, H.A., Linskens, E.J., Silverman, P.G., MacDonald, R., McCarten, J.R., Talley, K.M.C., Desai, P.J., Forte, M.L., Miller, M.A., Brasure, M., Nelson, V.A., Taylor, B.C., Ng, W., Ouellette, J.M., Greer, N.L., Sheets, K.M., Wilt, T.J., Butler, M.

Pharmacotherapy for the Treatment of Cannabis Use Disorder: A Systematic Review

Brian Desmarais — Tue, 03 Mar 2020 15:03:47 +0000

Date Added:

March 3, 2020

Journal/Publication:

Annals of Internal Medicine

Publication Date:

March 3, 2020

URL:

Pharmacotherapy for the Treatment of Cannabis Use Disorder: A Systematic Review

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.7326/M19-1105

MeSH

Cannabinoids and SSRIs appear NOT to be effective for treatment of cannabis use disorder. No other medications have been found to be effective to date. James W. Mold, MD, MPH

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BACKGROUND:

Cannabis use disorder (CUD) is a growing concern, and evidence-based data are needed to inform treatment options.

PURPOSE:

To review the benefits and risks of pharmacotherapies for the treatment of CUD.

DATA SOURCES:

MEDLINE, PsycINFO, Cochrane Database of Systematic Reviews, and clinical trial registries from inception through September 2019.

STUDY SELECTION:

Pharmacotherapy trials of adults or adolescents with CUD that targeted cannabis abstinence or reduction, treatment retention, withdrawal symptoms, and other outcomes.

DATA EXTRACTION:

Data were abstracted by 1 investigator and confirmed by a second. Study quality was dually assessed, and strength of evidence (SOE) was determined by consensus according to standard criteria.

DATA SYNTHESIS:

Across 26 trials, the evidence was largely insufficient. Low-strength evidence was found that selective serotonin reuptake inhibitors (SSRIs) do not reduce cannabis use or improve treatment retention. Low- to moderate-strength evidence was found that buspirone does not improve outcomes and that cannabinoids do not increase abstinence rates (moderate SOE), reduce cannabis use (low SOE), or increase treatment retention (low SOE). Across all drug studies, no consistent evidence of increased harm was found.

LIMITATIONS:

Few methodologically rigorous trials have been done. Existing trials are hampered by small sample sizes, high attrition rates, and heterogeneity of concurrent interventions and outcomes assessment.

CONCLUSION:

Although data on pharmacologic interventions for CUD are scarce, evidence exists that several drug classes, including cannabinoids and SSRIs, are ineffective. Because of increasing access to and use of cannabis in the general population, along with a high prevalence of CUD among current cannabis users, an urgent need exists for more research to identify effective pharmacologic treatments.

PRIMARY FUNDING SOURCE:

U.S. Department of Veterans Affairs. (PROSPERO: CRD42018108064).

Author/s:

Kondo, K.K., Morasco, B.J., Nugent S.M., O'Neil, ME, Ayers, C.K., Freeman, M., Kansagara, D.

Comparative Effectiveness of Different Treatment Pathways for Opioid Use Disorder

John Bayhi — Fri, 07 Feb 2020 13:59:45 +0000

Date Added:

February 7, 2020

Journal/Publication:

JAMA Network Open

Publisher:

American Medical Association

Publication Date:

February 5, 2020

Issue:

Volume:

Pages:

e1920622

URL:

Comparative Effectiveness of Different Treatment Pathways for Opioid Use Disorder

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jamanetworkopen.2019.20622

Keywords

PMID (1):

32022884

MeSH

retrospective studies

Inpatients

outpatients

Comparative Effectiveness Research

opioid-related disorders

If the goal is to reduce overdoses and ED visits, the best treatment options appear to include buprenorphine or methadone. James W. Mold, MD, MPH

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IMPORTANCE:

Although clinical trials demonstrate the superior effectiveness of medication for opioid use disorder (MOUD) compared with nonpharmacologic treatment, national data on the comparative effectiveness of real-world treatment pathways are lacking.

OBJECTIVE:

To examine associations between opioid use disorder (OUD) treatment pathways and overdose and opioid-related acute care use as proxies for OUD recurrence.

DESIGN, SETTING, AND PARTICIPANTS:

This retrospective comparative effectiveness research study assessed deidentified claims from the OptumLabs Data Warehouse from individuals aged 16 years or older with OUD and commercial or Medicare Advantage coverage. Opioid use disorder was identified based on 1 or more inpatient or 2 or more outpatient claims for OUD diagnosis codes within 3 months of each other; 1 or more claims for OUD plus diagnosis codes for opioid-related overdose, injection-related infection, or inpatient detoxification or residential services; or MOUD claims between January 1, 2015, and September 30, 2017. Data analysis was performed from April 1, 2018, to June 30, 2019.

EXPOSURES:

One of 6 mutually exclusive treatment pathways, including (1) no treatment, (2) inpatient detoxification or residential services, (3) intensive behavioral health, (4) buprenorphine or methadone, (5) naltrexone, and (6) nonintensive behavioral health.

MAIN OUTCOMES AND MEASURES:

Opioid-related overdose or serious acute care use during 3 and 12 months after initial treatment.

RESULTS:

A total of 40 885 individuals with OUD (mean [SD] age, 47.73 [17.25] years; 22 172 [54.2%] male; 30 332 [74.2%] white) were identified. For OUD treatment, 24 258 (59.3%) received nonintensive behavioral health, 6455 (15.8%) received inpatient detoxification or residential services, 5123 (12.5%) received MOUD treatment with buprenorphine or methadone, 1970 (4.8%) received intensive behavioral health, and 963 (2.4%) received MOUD treatment with naltrexone. During 3-month follow-up, 707 participants (1.7%) experienced an overdose, and 773 (1.9%) had serious opioid-related acute care use. Only treatment with buprenorphine or methadone was associated with a reduced risk of overdose during 3-month (adjusted hazard ratio [AHR], 0.24; 95% CI, 0.14-0.41) and 12-month (AHR, 0.41; 95% CI, 0.31-0.55) follow-up. Treatment with buprenorphine or methadone was also associated with reduction in serious opioid-related acute care use during 3-month (AHR, 0.68; 95% CI, 0.47-0.99) and 12-month (AHR, 0.74; 95% CI, 0.58-0.95) follow-up.

CONCLUSIONS AND RELEVANCE:

Treatment with buprenorphine or methadone was associated with reductions in overdose and serious opioid-related acute care use compared with other treatments. Strategies to address the underuse of MOUD are needed.

Author/s:

Wakeman, SE, Larochelle, MR, Ameli, O, Chaisson, CE, McPheeters, JT, Crown, WH, Azocar, F, Sanghavi, DM

Testosterone Treatment in Adult Men With Age-Related Low Testosterone: A Clinical Guideline From the American College of Physicians

John Bayhi — Tue, 07 Jan 2020 19:22:41 +0000

Date Added:

January 7, 2020

Journal/Publication:

Annals of Internal Medicine

Publisher:

American College of Physicians

Publication Date:

January 7, 2020

URL:

Testosterone Treatment in Adult Men With Age-Related Low Testosterone: A Clinical Guideline From the American College of Physicians

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.7326/M19-0882

Keywords

testosterone

guidelines

age-related testosterone deficiency

PMID (1):

31905405

MeSH

depressive disorder, major

Sexual Dysfunction

Physiological

Cognition

cardiovascular diseases

It appears that testosterone replacement in men with documented age-related testosterone deficiency may have small benefits in terms of sexual function and quality of life with no effect on physical function and no increase in significant adverse events. James W. Mold, MD, MPH

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DESCRIPTION:

The American College of Physicians (ACP) developed this guideline to provide clinical recommendations based on the current evidence of the benefits and harms of testosterone treatment in adult men with age-related low testosterone. This guideline is endorsed by the American Academy of Family Physicians.

METHODS:

The ACP Clinical Guidelines Committee based these recommendations on a systematic review on the efficacy and safety of testosterone treatment in adult men with age-related low testosterone. Clinical outcomes were evaluated by using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system and included sexual function, physical function, quality of life, energy and vitality, depression, cognition, serious adverse events, major adverse cardiovascular events, and other adverse events.

TARGET AUDIENCE AND PATIENT POPULATION:

The target audience includes all clinicians, and the target patient population includes adult men with age-related low testosterone.

RECOMMENDATION 1A:

ACP suggests that clinicians discuss whether to initiate testosterone treatment in men with age-related low testosterone with sexual dysfunction who want to improve sexual function (conditional recommendation; low-certainty evidence). The discussion should include the potential benefits, harms, costs, and patient's preferences.

RECOMMENDATION 1B:

ACP suggests that clinicians should reevaluate symptoms within 12 months and periodically thereafter. Clinicians should discontinue testosterone treatment in men with age-related low testosterone with sexual dysfunction in whom there is no improvement in sexual function (conditional recommendation; low-certainty evidence).

RECOMMENDATION 1C:

ACP suggests that clinicians consider intramuscular rather than transdermal formulations when initiating testosterone treatment to improve sexual function in men with age-related low testosterone, as costs are considerably lower for the intramuscular formulation and clinical effectiveness and harms are similar.

RECOMMENDATION 2:

ACP suggests that clinicians not initiate testosterone treatment in men with age-related low testosterone to improve energy, vitality, physical function, or cognition (conditional recommendation; low-certainty evidence).

Author/s:

Qaseem, A., Horwitch, CA, Vijan, S, Etxeandia-Ikobaltzeta, I, Kansagara, D, Clinical Guidelines Committee of the American College of Physicians

Building a Group-Based Opioid Treatment (GBOT) blueprint: a qualitative study delineating GBOT implementation

John Bayhi — Thu, 02 Jan 2020 21:06:56 +0000

Date Added:

January 2, 2020

Journal/Publication:

Addiction Science & Clinical Practice

Publisher:

BioMed Central Ltd

Publication Date:

December 27, 2019

Issue:

Volume:

URL:

Building a Group-Based Opioid Treatment (GBOT) blueprint: a qualitative study delineating GBOT implementation

Type:

Practice Management Research Results

Format:

Article

DOI (1):

10.1186/s13722-019-0176-y

Keywords

Buprenorphine-naloxone

GBOT

Group psychotherapy

Group visit

Implementation science

Shared medical appointment

Group-Based Opioid Treatment

PMID (1):

31882001

MeSH

Humans

Focus Groups

Patient Participation

outpatients

motivation

opioid-related disorders

This article could be helpful to medical directors, practice facilitators, and QI managers who are tasked with creating systems for addressing patients with opioid use disorders. James W. Mold, MD, MPH

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BACKGROUND:

Group-Based Opioid Treatment (GBOT) has recently emerged as a mechanism for treating patients with opioid use disorder (OUD) in the outpatient setting. However, the more practical "how to" components of successfully delivering GBOT has received little attention in the medical literature, potentially limiting its widespread implementation and utilization. Building on a previous case series, this paper delineates the key components to implementing GBOT by asking: (a) What are the core components to GBOT implementation, and how are they defined? (b) What are the malleable components to GBOT implementation, and what conceptual framework should providers use in determining how to apply these components for effective delivery in their unique clinical environment?

METHODS:

To create a blueprint delineating GBOT implementation, we integrated findings from a previously conducted and separately published systematic review of existing GBOT studies, conducted additional literature review, reviewed best practice recommendations and policies related to GBOT and organizational frameworks for implementing health systems change. We triangulated this data with a qualitative thematic analysis from 5 individual interviews and 2 focus groups representing leaders from 5 different GBOT programs across our institution to identify the key components to GBOT implementation, distinguish "core" and "malleable" components, and provide a conceptual framework for considering various options for implementing the malleable components.

RESULTS:

We identified 6 core components to GBOT implementation that optimize clinical outcomes, comply with mandatory policies and regulations, ensure patient and staff safety, and promote sustainability in delivery. These included consistent group expectations, team-based approach to care, safe and confidential space, billing compliance, regular monitoring, and regular patient participation. We identified 14 malleable components and developed a novel conceptual framework that providers can apply when deciding how to employ each malleable component that considers empirical, theoretical and practical dimensions.

CONCLUSION:

While further research on the effectiveness of GBOT and its individual implementation components is needed, the blueprint outlined here provides an initial framework to help office-based opioid treatment sites implement a successful GBOT approach and hence potentially serve as future study sites to establish efficacy of the model. This blueprint can also be used to continuously monitor how components of GBOT influence treatment outcomes, providing an empirical framework for the ongoing process of refining implementation strategies.

Author/s:

Sokol, R, Albanese, M, Chew, A, Early, J, Grossman, E, Roll, D, Sawin, G, Wu, DJ, Schuman-Olivier, Z

A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study

John Bayhi — Wed, 13 Nov 2019 18:19:52 +0000

Date Added:

November 13, 2019

Journal/Publication:

Diabetes Care

Publisher:

American Diabetes Association

Publication Date:

October 16, 2019

URL:

A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.2337/dc19-0476

Keywords

wound therapy

diabetes

diabetic foot ulcer

topical wound oxygen therapy

two2

PMID (1):

31619393

MeSH

Oxygen Inhalation Therapy

treatment outcome

Home Care Services

Intermittent pressurized oxygen therapy appears to improve wound healing in diabetic foot ulcers. James W. Mold, MD, MPH

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OBJECTIVE:

Topical oxygen has been used for the treatment of chronic wounds for more than 50 years. Its effectiveness remains disputed due to the limited number of robust high-quality investigations. The aim of this study was to assess the efficacy of multimodality cyclical pressure Topical Wound Oxygen (TWO2) home care therapy in healing refractory diabetic foot ulcers (DFUs) that had failed to heal with standard of care (SOC) alone.

RESEARCH DESIGN AND METHODS:

Patients with diabetes and chronic DFUs were randomized (double-blind) to either active TWO2 therapy or sham control therapy-both in addition to optimal SOC. The primary outcome was the percentage of ulcers in each group achieving 100% healing at 12 weeks. A group sequential design was used for the study with three predetermined analyses and hard stopping rules once 73, 146, and ultimately 220 patients completed the 12-week treatment phase.

RESULTS:

At the first analysis point, the active TWO2 arm was found to be superior to the sham arm, with a closure rate of 41.7% compared with 13.5%. This difference in outcome produced an odds ratio (OR) of 4.57 (97.8% CI 1.19, 17.57), P = 0.010. After adjustment for University of Texas Classification (UTC) ulcer grade, the OR increased to 6.00 (97.8% CI 1.44, 24.93), P = 0.004. Cox proportional hazards modeling, also after adjustment for UTC grade, demonstrated >4.5 times the likelihood to heal DFUs over 12 weeks compared with the sham arm with a hazard ratio of 4.66 (97.8% CI 1.36, 15.98), P = 0.004. At 12 months postenrollment, 56% of active arm ulcers were closed compared with 27% of the sham arm ulcers (P = 0.013).

CONCLUSIONS:

This sham-controlled, double-blind randomized controlled trial demonstrates that, at both 12 weeks and 12 months, adjunctive cyclical pressurized TWO2 therapy was superior in healing chronic DFUs compared with optimal SOC alone.

Author/s:

Frykberg, RG, Franks, PJ, Edmonds, M, Brantley, JN, Téot, L, Wild, T, Garoufalis, MG, Lee, AM, Thompson, JA, Reach, G, Dove, CR, Lachgar, K, Grotemeyer, D, Renton, SC, TWO2 Study Group

Catheter Ablation of Atrial Fibrillation: An Overview for Clinicians

Tracy Ashby — Fri, 30 Nov 2018 06:00:00 +0000

Date Added:

November 30, 2018

Journal/Publication:

Advances In Therapy

Publisher:

Springer Healthcare

Publication Date:

July 21, 2017

Issue:

Volume:

Pages:

1897-1917

URL:

Catheter Ablation of Atrial Fibrillation: An Overview for Clinicians

Type:

Meta-analyses, Reviews, and Guidelines, Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1007/s12325-017-0590-z

Keywords

atrial fibrillation

catheter ablation

interventional cardiology

pulmonary vein isolation

stroke

substrate modification

PMID (1):

28733782

MeSH

This is a non-systematic but still useful review of the indications, benefits, and risks associated with catheter ablation for patients with atrial fibrillation.

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Abstract

Catheter ablation (CA) of atrial fibrillation (AF) is currently one of the most commonly performed electrophysiology procedures. Ablation of paroxysmal AF is based on the elimination of triggers by pulmonary vein isolation (PVI), while different strategies for additional AF substrate modification on top of PVI have been proposed for ablation of persistent AF. Nowadays, various technologies for AF ablation are available. The radiofrequency point-by-point ablation navigated by electro-anatomical mapping system and cryo-balloon technology are comparable in terms of the efficacy and safety of the PVI procedure. Long-term success of AF ablation including multiple procedures varies from 50 to 80%. Arrhythmia recurrences commonly occur, mostly due to PV reconnection. The recurrences are particularly common in patients with non-paroxysmal AF, dilated left atrium and the "early recurrence" of AF within the first 2–3 post-procedural months. In addition, this complex procedure can be accompanied by serious complications, such as cardiac tamponade, stroke, atrio-esophageal fistula and PV stenosis. Therefore, CA represents a second-line treatment option after a trial of antiarrhythmic drug(s). Good candidates for the procedure are relatively younger patients with symptomatic and frequent episodes of AF, with no significant structural heart disease and no significant left atrial enlargement. Randomized trials demonstrated the superiority of ablation compared to antiarrhythmic drugs in terms of improving the quality of life and symptoms in AF patients. However, nonrandomized studies reported additional clinical benefits from ablation over drug therapy in selected AF patients, such as the reduction of the mortality and stroke rates and the recovery of tachyarrhythmia-induced cardiomyopathy. Future research should enable the creation of more durable ablative lesions and the selection of the optimal lesion set in each patient according to the degree of atrial remodeling. This could provide better long-term CA success and expand indications for the procedure, especially among the patients with non-paroxysmal AF.

Author/s:

Nebojša, Marinković, Milan, Lenarczyk, Radoslaw, Tilz, Roland, Potpara, Tatjana S.