scholarly journals A Mapping Literature Review of Medical Cannabis Clinical Outcomes and Quality of Evidence in Approved Conditions in the USA from 2016 to 2019

2021 ◽  
pp. 1-22
Author(s):  
Sebastian Jugl ◽  
Aimalohi Okpeku ◽  
Brianna Costales ◽  
Earl J. Morris ◽  
Golnoosh Alipour-Haris ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
The Body ◽  
Medical Cannabis ◽  
High Quality ◽  
Chronic Noncancer Pain ◽  
High Quality Evidence ◽  
Improved Outcomes ◽  
Noncancer Pain ◽  
Study Setting

In 2017, a National Academies of Sciences, Engineering, and Medicine (NASEM) report comprehensively evaluated the body of evidence regarding cannabis health effects through the year 2016. The objectives of this study are to identify and map the most recently (2016–2019) published literature across approved conditions for medical cannabis and to evaluate the quality of identified recent systematic reviews, published following the NASEM report. Following the literature search from 5 databases and consultation with experts, 11 conditions were identified for evidence compilation and evaluation: amyotrophic lateral sclerosis, autism, cancer, chronic noncancer pain, Crohn’s disease, epilepsy, glaucoma, human immunodeficiency virus/AIDS, multiple sclerosis (MS), Parkinson’s disease, and posttraumatic stress disorder. A total of 198 studies were included after screening for condition-specific relevance and after imposing the following exclusion criteria: preclinical focus, non-English language, abstracts only, editorials/commentary, case studies/series, and non-U.S. study setting. Data extracted from studies included: study design type, outcome definition, intervention definition, sample size, study setting, and reported effect size. Few completed randomized controlled trials (RCTs) were identified. Studies classified as systematic reviews were graded using the Assessing the Methodological Quality of Systematic Reviews-2 tool to evaluate the quality of evidence. Few high-quality systematic reviews were available for most conditions, with the exceptions of MS (9 of 9 graded moderate/high quality; evidence for 2/9 indicating cannabis improved outcomes; evidence for 7/9 indicating cannabis inconclusive), epilepsy (3 of 4 graded moderate/high quality; 3 indicating cannabis improved outcomes; 1 indicating cannabis inconclusive), and chronic noncancer pain (12 of 13 graded moderate/high quality; evidence for 7/13 indicating cannabis improved outcomes; evidence from 6/7 indicating cannabis inconclusive). Among RCTs, we identified few studies of substantial rigor and quality to contribute to the evidence base. However, there are some conditions for which significant evidence suggests that select dosage forms and routes of administration likely have favorable risk-benefit ratios (i.e., epilepsy and chronic noncancer pain). The body of evidence for medical cannabis requires more rigorous evaluation before consideration as a treatment option for many conditions, and evidence necessary to inform policy and treatment guidelines is currently insufficient for many conditions.

scholarly journals A Mapping Literature Review of Medical Cannabis Clinical Outcomes and Quality of Evidence in Approved Conditions in the United States, from 2016 to 2019

2021 ◽  
Author(s):  
Sebastian Jugl ◽  
Aimalohi Okpeku ◽  
Brianna Costales ◽  
Earl Morris ◽  
Golnoosh Alipour-Harris ◽  
...  
Keyword(s):  
United States ◽  
Chronic Pain ◽  
Systematic Reviews ◽  
The United States ◽  
Evidence Base ◽  
Medical Cannabis ◽  
High Quality ◽  
Quality Of Evidence ◽  
Study Setting

Background: Medical cannabis is available to patients by physician order in two-thirds of the United States (U.S.) as of 2020, but remains classified as an illicit substance by federal law. States that permit medical cannabis ordered by a physician typically require a diagnosed medical condition that is considered qualifying by respective state law. Objectives: To identify and map the most recently (2016-2019) published clinical and scientific literature across approved conditions for medical cannabis, and to evaluate the quality of identified recent systematic reviews. Methods: Literature search was conducted from five databases (PubMed, Embase, Web of Science, Cochrane, and ClinicalTrials.gov), with expansion and update from the National Academies of Sciences, Engineering, and Medicine’s (NASEM) comprehensive evidence review through 2016 of the health effects of cannabis on several conditions. Following consultation with experts and stakeholders, 11 conditions were identified for evidence evaluation: amyotrophic lateral sclerosis (ALS), autism, cancer, chronic pain, Crohn’s disease, epilepsy, glaucoma, HIV/AIDS, multiple sclerosis (MS), Parkinson’s disease, and posttraumatic stress disorder (PTSD). The following exclusion criteria were imposed: preclinical focus, non-English language, abstracts only, editorials/commentary, case studies/series, and non-U.S. study setting. Data extracted from studies included: study design type, outcome, intervention, sample size, study setting, and reported effect size. Studies classified as systematic reviews with or without meta-analysis were graded using the AMSTAR-2 tool by two raters to evaluate the quality of evidence, with additional raters to resolve cases of evidence grade disagreement. Results: A total of 438 studies were included after screening. Five completed randomized controlled trials (RCTs) were identified, and an additional 11 trials were ongoing, and 1 terminated. Cancer, chronic pain, and epilepsy were the most researched topic areas, representing more than two-thirds of all reviewed studies. The quality of evidence assessment for each condition suggests that few high-quality systematic reviews are available for most conditions, with the exceptions of MS, epilepsy, and chronic pain. In those areas, findings on chronic pain are mostly in alignment with the previous literature, suggesting that cannabis or cannabinoids are potentially beneficial in treating chronic neuropathic pain. In epilepsy, findings suggest that cannabidiol is potentially effective in reducing seizures in pediatric patients with drug-resistant Dravet and Lennox-Gastaut syndromes. In MS, recent high-quality systematic reviews did not include new RCTs, and are therefore not substantially expanding the evidence base. In sum, the most recent clinical evidence suggests that for most of the conditions assessed, we identified few studies of substantial rigor and quality to contribute to the evidence base. However, there are some conditions for which significant evidence suggests that select dosage forms and routes of administration likely have favorable risk-benefit ratios (i.e., epilepsy and chronic pain), with the higher quality of evidence for epilepsy driven by FDA-approved formulations for cannabis-based seizure treatments. Conclusion: The body of evidence for medical cannabis requires more rigorous evaluation before consideration as a treatment option for many conditions and evidence necessary to inform policy and treatment guidelines is currently insufficient for many conditions.

scholarly journals Rituximab for the Treatment of Neuromyelitis Optica Spectrum Disorder

2021 ◽  
Vol 1 (2) ◽  
Author(s):  
Srabani Banerjee ◽  
Robyn Butcher
Keyword(s):  
Economic Evaluation ◽  
B Cell ◽  
Relapse Rate ◽  
Systematic Reviews ◽  
Neuromyelitis Optica Spectrum Disorder ◽  
High Quality ◽  
High Quality Evidence ◽  
Cell Monitoring ◽  
Quality Evidence

Four systematic reviews, 1 randomized controlled trial (RCT), 1 economic evaluation, and 2 evidence-based guidelines were identified. Four systematic reviews (2 that included moderate- to high-quality evidence and 2 that did not report the quality of the evidence) and 1 RCT (that provided high-quality evidence) reported on the clinical effectiveness of rituximab (RTX) for the treatment of neuromyelitis optica spectrum disorder (NMOSD). Overall, RTX treatment appeared to reduce the relapse rate and disability level compared with pre-treatment or placebo. In terms of reduction in relapse rate and disability, RTX was either better or not different from azathioprine (AZA). For relapse rates, disability levels, and incidence of adverse events, network meta-analyses showed that no treatment was favoured for comparisons between RTX, mycophenolate mofetil (MMF), and cyclophosphamide (CYP). One economic evaluation (of moderate quality) showed that, for patients with NMOSD, in the context of the Thai health care system, RTX biosimilar with CD27+ memory B cell monitoring regimen had the highest probability (48%) of being cost-effective, followed by AZA (30%), MMF (13%), RTX with CD27+ memory B cell monitoring regimen (9%), RTX biosimilar (0%), and RTX (0%) at a willingness-to-pay threshold of 160,000 Thai bhat (equivalent to US$5,289 in 2019 values) per quality-adjusted life-year gained. The 2 guidelines recommended immunosuppressants (RTX, AZA, and MMF) for prevention of NMOSD attacks. In addition, 1 guideline mentioned that tocilizumab, eculizumab, inebilizumab, and satralizumab can be used in NMOSD leave it up to patients who have no response to other immunosuppressants. The quality of the evidence that informed the guidelines and the strength of the recommendations were not reported. Findings need to be interpreted with caution given the limited quantity of evidence on comparative efficacy and safety between various immunosuppressants, that many of the included primary studies were retrospective studies, the heterogeneity among the studies included in the systematic reviews, and the lack of clarity with respect to the strength of the recommendations.

scholarly journals The Effectiveness of Virtual Reality for Rehabilitation of Parkinson Disease: An Overview of Systematic Reviews and Meta-Analyses

2021 ◽  
Author(s):  
Yaqin Lu ◽  
Yonggui Ge ◽  
Wanqiang Chen ◽  
Wenting Xing ◽  
Lushan Wei ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Parkinson Disease ◽  
Systematic Reviews ◽  
Methodological Quality ◽  
Cochrane Library ◽  
High Quality ◽  
High Quality Evidence ◽  
Meta Analyses ◽  
Quality Evidence

Abstract Background: An increasing number of systematic reviews (SRs) and meta-analyses (MAs) of clinical trials have begun to investigate the effects of virtual reality (VR) in patients with Parkinson disease (PD). The aim of this overview of was to systematically summarize the current best evidence for the effectiveness of VR therapy for the rehabilitation of people with PD.Methods: We searched SRs/MAs based on randomized controlled trials (RCTs) for relevant literature in PubMed, Embase and Cochrane library databases from inception to December 5, 2020. The methodological quality of included SRs/MAs was evaluated with the Assessing the Methodological Quality of Systematic Reviews 2 (AMSTAR-2), and the evidence quality of outcome measures with the Grading of Recommendations, Assessment, Development and Evaluation (GRADE). Results: A total of nine SRs/MAs were included. The evaluation with AMSTAR-2 showed that all included SRs/MAs but one were rated as low or critically low quality studies. The GRADE criteria revealed 19 studies with very-low-quality evidences, 20 with low-quality evidences, 8 with moderate-quality evidences, and 1 with high-quality evidence. Effectiveness evaluation showed that VR therapy had greater improvement of stride length compared with control groups. However, there were inconsistent results (better or similar effects) regarding to gait speed, gait ability, balance, global motor function, activities of daily living, quality of life, postural control, cognitive function, and neuropsychiatric symptoms.Conclusions: VR therapy appears to be a promising and effective treatment for PD, but there is still a lack of high-quality evidence. In the future, rigorous-designed, high-quality RCTs with larger sample sizes are needed to further verify the effectiveness of VR therapy in the treatment of PD.

scholarly journals Measurement properties of patient-reported outcome measures (PROMs) in hyperhidrosis: a systematic review

2021 ◽  
Author(s):  
Michaela Gabes ◽  
Helge Knüttel ◽  
Gesina Kann ◽  
Christina Tischer ◽  
Christian J. Apfelbacher
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Measurement Properties ◽  
High Quality ◽  
High Quality Evidence ◽  
Patient Reported ◽  
Quality Evidence

Abstract Purpose To critically appraise, compare and summarize the quality of all existing PROMs that have been validated in hyperhidrosis to at least some extend by applying the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Thereby, we aim to give a recommendation for the use of PROMs in future clinical trials in hyperhidrosis. Methods We considered studies evaluating, describing or comparing measurement properties of PROMs as eligible. A systematic literature search in three big databases (MEDLINE, EMBASE and Web of Science) was performed. We assessed the methodological quality of each included study using the COSMIN Risk of Bias checklist. Furthermore, we applied predefined quality criteria for good measurement properties and finally, graded the quality of the evidence. Results Twenty-four articles reporting on 13 patient-reported outcome measures were included. Three instruments can be further recommended for use. They showed evidence for sufficient content validity and moderate- to high-quality evidence for sufficient internal consistency. The methodological assessment showed existing evidence gaps for eight other PROMs, which therefore require further validation studies to make an adequate decision on their recommendation. The Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) and the short-form health survey with 36 items (SF-36) were the only questionnaires not recommended for use in patients with hyperhidrosis due to moderate- to high-quality evidence for insufficient measurement properties. Conclusion Three PROMs, the Hyperhidrosis Quality of Life Index (HidroQoL), the Hyperhidrosis Questionnaire (HQ) and the Sweating Cognitions Inventory (SCI), can be recommended for use in future clinical trials in hyperhidrosis. Results obtained with these three instruments can be seen as trustworthy. Nevertheless, further validation of all three PROMs is desirable. Systematic review registration PROSPERO CRD42020170247

scholarly journals The effectiveness of M-Health associated with cardiac rehabilitation on functional capacity and cardiovascular risk factors: a systematic review and meta-analysis

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
A C Campagnolo Goncalves Toledo ◽  
N Soares De Almeida ◽  
A Pierucci ◽  
A Straioto Salomao ◽  
I Ribeiro Lemes ◽  
...  
Keyword(s):  
Functional Capacity ◽  
Meta Analysis ◽  
Medium Term ◽  
Short Term ◽  
High Quality ◽  
Quality Of Evidence ◽  
High Quality Evidence ◽  
Quality Evidence

Abstract Introduction Smartphone applications for health (M-Health) seem to overcome barriers to access Cardiovascular Rehabilitation Programs (CRP), because of their high degree of acceptance and also their potential to influence the frequency of physical exercise in weight loss. Objective To analyze the effectiveness of the combination of M-Health and CRP compared to CRP alone on functional capacity, adherence to CRP, management of cardiovascular risk factors in cardiac patients. Design Systematic Review and Meta-Analysis. Methods The following databases were used Medline via Ovid, EMBASE, Central, PEDro and SPORTDiscus via EBSCOhost from their inception until July/2020. We included randomized controlled trials investigating the effects of M-Health in combination with CRP compared to CRP alone in adults with heart disease, and the interventions with M-Health consisted of text messages, e-mails, and applications. The primary outcome of this review was functional capacity, measured by VO2peak, or self-reported physical activity (METs.min/week). PEDro scale was used to assess the methodological quality of the studies and the GRADE approach to assess the overall quality of evidence. Pooled estimates were calculated using a random effect model to obtain mean difference (MD) or standardized mean differences (SMD) and their respectives 95% confidence intervals (CI). Results Nineteen RCTs were eligible, the median risk of bias was 7 out of 10 points. The primary endpoint was analyzed by subgroups, time of intervention and kind of type CRP, eigthteen of these studies assessed functional capacity. CRP in combination with a m-health intervention was more effective than CRP alone in improving VO2peak, ml/min/kg, (MD: 0.84, CI: 0.30 to 1.38; I2=0%, high quality evidence, 12 trials, n=1889) at short-term follow-up, but at medium-term follow-up (MD: 0.84, CI: −0.26 to 1.41; I2=0%, high quality evidence, 8 trials, n=927,). Similarly, CRP associated with m-health was superior to CRP alone in increasing self-reported at short-term, METs.min/week, (MD:1.31, CI: −0.24 to 2.37; I2 = not aplicable, very low quality evidence, 1 trial, n=18), and at medium-term follow-up (MD: 0.18, CI: −0.01 to 0.36; I2=56%, moderate quality evidence, 4 trials, n=1107). Conclusion High quality of evidence shows that M-Health improves cardiorespiratory fitness at short-term follow-up. In addition, supervised program showed to be more effective than non-supervised. Funding Acknowledgement Type of funding sources: None.

scholarly journals Impact of Adjustment for Quality on Results of Metaanalyses of Diagnostic Accuracy

2007 ◽  
Vol 53 (2) ◽  
pp. 164-172 ◽  
Author(s):  
Mariska Leeflang ◽  
Johannes Reitsma ◽  
Rob Scholten ◽  
Anne Rutjes ◽  
Marcello Di Nisio ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Quality Assessment ◽  
Confidence Intervals ◽  
Systematic Reviews ◽  
Methodological Quality ◽  
Patient Characteristics ◽  
Clinical Decision ◽  
High Quality ◽  
Poor Reporting

Abstract Background: We examined whether and to what extent different strategies of defining and incorporating quality of included studies affect the results of metaanalyses of diagnostic accuracy. Methods: We evaluated the methodological quality of 487 diagnostic-accuracy studies in 30 systematic reviews with the QUADAS (Quality Assessment of Diagnostic-Accuracy Studies) checklist. We applied 3 strategies that varied both in the definition of quality and in the statistical approach to incorporate the quality-assessment results into metaanalyses. We compared magnitudes of diagnostic odds ratios, widths of their confidence intervals, and changes in a hypothetical clinical decision between strategies. Results: Following 2 definitions of quality, we concluded that only 70 or 72 of 487 studies were of “high quality”. This small number was partly due to poor reporting of quality items. None of the strategies for accounting for differences in quality led systematically to accuracy estimates that were less optimistic than ignoring quality in metaanalyses. Limiting the review to high-quality studies considerably reduced the number of studies in all reviews, with wider confidence intervals as a result. In 18 reviews, the quality adjustment would have resulted in a different decision about the usefulness of the test. Conclusions: Although reporting the results of quality assessment of individual studies is necessary in systematic reviews, reader wariness is warranted regarding claims that differences in methodological quality have been accounted for. Obstacles for adjusting for quality in metaanalyses are poor reporting of design features and patient characteristics and the relatively low number of studies in most diagnostic reviews.

scholarly journals Updated meta-review of evidence on support for carers

2018 ◽  
Vol 23 (3) ◽  
pp. 196-207 ◽  
Author(s):  
Jane Dalton ◽  
Sian Thomas ◽  
Melissa Harden ◽  
Alison Eastwood ◽  
Gillian Parker
Keyword(s):  
Mental Health ◽  
Systematic Reviews ◽  
Mental Health Problems ◽  
Psychosocial Support ◽  
Psychosocial Interventions ◽  
Negative Effects ◽  
High Quality ◽  
People With Dementia ◽  
Meta Review

Objective To update a 2010 meta-review of systematic reviews of effective interventions to support carers of ill, disabled, or older adults. In this article, we report the most promising interventions based on the best available evidence. Methods Rapid meta-review of systematic reviews published from January 2009 to 2016. Results Sixty-one systematic reviews were included (27 high quality, 25 medium quality, and nine low quality). The quality of reviews has improved since the original review, but primary studies remain limited in quality and quantity. Fourteen high quality reviews focused on carers of people with dementia, four on carers of those with cancer, four on carers of people with stroke, three on carers of those at the end of life with various conditions, and two on carers of people with mental health problems. Multicomponent interventions featured prominently, emphasizing psychosocial or psychoeducational content, education and training. Improved outcomes for carers were reported for mental health, burden and stress, and wellbeing or quality of life. Negative effects were reported in reviews of respite care. As with earlier work, we found little robust evidence on the cost-effectiveness of reviewed interventions. Conclusions There is no ‘one size fits all’ intervention to support carers. There is potential for effective support in specific groups of carers, such as shared learning, cognitive reframing, meditation, and computer-delivered psychosocial support for carers of people with dementia. For carers of people with cancer, effective support may include psychosocial interventions, art therapy, and counselling. Carers of people with stroke may also benefit from counselling. More good quality, theory-based, primary research is needed.

scholarly journals Health-Related Quality of Life among Chronic Opioid Users, Nonchronic Opioid Users, and Nonopioid Users with Chronic Noncancer Pain

2018 ◽  
Vol 53 (5) ◽  
pp. 3329-3349 ◽  
Author(s):  
Corey J. Hayes ◽  
Xiaocong Li ◽  
Chenghui Li ◽  
Anuj Shah ◽  
Niranjan Kathe ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Related Quality ◽  
Chronic Noncancer Pain ◽  
Related Quality ◽  
Health Related ◽  
Noncancer Pain ◽  
Opioid Users

scholarly journals Can prospective systematic reviews of animal studies improve clinical translation?

2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Pandora Pound ◽  
Merel Ritskes-Hoitinga
Keyword(s):  
Clinical Trials ◽  
Systematic Reviews ◽  
Animal Studies ◽  
Poor Quality ◽  
Human Studies ◽  
Clinical Knowledge ◽  
Safety And Efficacy ◽  
High Quality Evidence ◽  
Animal Data

AbstractSystematic reviews are powerful tools with the potential to generate high quality evidence. Their application to animal studies has been instrumental in exposing the poor quality of these studies, as well as a catalyst for improvements in study design, conduct and reporting. It has been suggested that prospective systematic reviews of animal studies (i.e. systematic reviews conducted prior to clinical trials) would allow scrutiny of the preclinical evidence, providing valuable information on safety and efficacy, and helping to determine whether clinical trials should proceed. However, while prospective systematic reviews allow valuable scrutiny of the preclinical animal data, they are not necessarily able to reliably predict the safety and efficacy of an intervention when trialled in humans. Consequently, they may not reliably safeguard humans participating in clinical trials and might potentially result in lost opportunities for beneficial clinical treatments. Furthermore, animal and human studies are often conducted concurrently, which not only makes prospective systematic reviews of animal studies impossible, but suggests that animal studies do not inform human studies in the manner presumed. We suggest that this points to a confused attitude regarding animal studies, whereby tradition demands that they precede human studies but practice indicates that their findings are often ignored. We argue that it is time to assess the relative contributions of animal and human research in order to better understand how clinical knowledge is actually produced.

scholarly journals Quality of the Evidence Supporting the Role of Oral Nutritional Supplements in the Management of Malnutrition: An Overview of Systematic Reviews and Meta-Analyses

2020 ◽  
Author(s):  
Christine Baldwin ◽  
Rosemary Smith ◽  
Michelle Gibbs ◽  
C Elizabeth Weekes ◽  
Peter W Emery
Keyword(s):  
At Risk ◽  
Systematic Reviews ◽  
Methodological Quality ◽  
Hospital Readmissions ◽  
Nutritional Supplement ◽  
Measurement Tool ◽  
High Quality ◽  
Oral Nutritional Supplements ◽  
Meta Analyses

ABSTRACT There is considerable heterogeneity across the findings of systematic reviews of oral nutritional supplement (ONS) interventions, presenting difficulties for healthcare decision-makers and patients alike. It is not known whether heterogeneity arises from differences in patient populations or relates to methodological rigor. This overview aimed to collate and compare findings from systematic reviews of ONSs compared with routine care in adult patients who were malnourished or at risk of malnutrition with any clinical condition and to examine their methodological quality. Three electronic databases were searched to July 2019, supplemented with hand-searching. Data on all outcomes were extracted and review methodological quality assessed using A MeaSurement Tool for Assessment of systematic Reviews (AMSTAR). Twenty-two reviews were included, 11 in groups from mixed clinical backgrounds and 11 in specific clinical conditions. Ninety-one meta-analyses were identified for 12 different outcomes but there was discordance between results. Significant benefits of ONSs were reported in 4 of 4 analyses of energy intake, 7 of 11 analyses of body weight, 7 of 22 analyses of mortality, 10 of 17 analyses of complications (total and infectious), 1 of 3 analyses of muscle strength, 4 of 9 analyses of body composition/nutritional status, 2 of 14 analyses of length of stay, and 2 of 5 analyses of hospital readmissions. Ten reviews were high quality (AMSTAR scores 8–11), 9 moderate (AMSTAR scores 3–8), and 3 poor (AMSTAR scores 0–3). Methodological deficiencies were limitations to searches, poor reporting of heterogeneity, and failure to incorporate quality of evidence into any recommendations. Discordance between reviews was not markedly reduced when only high-quality reviews were considered. Evidence for the effects of ONS in malnourished patients or those who are at risk of malnutrition is uncertain, and discordance in results can arise from differences in clinical background of patients or the etiological basis of malnutrition.

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