Establishing  Credibility for Medical Marijuana: The Proposed Prometheus Dispensary Registry for Botanical  Cannabis

A previous commentary in INNOVATIONS in Pharmacy argued that, given the lack of evidence for outcomes in medical marijuana, outside of a handful of randomized clinical trials and even fewer observational studies, good clinical practice points to the need for monitoring patients who received cannabis through certified medical marijuana dispensaries. The commentary noted the lack of standards for monitoring cannabis patients and the lack of feedback from the dispensary to providers. Botanical cannabis administration was occurring in, effectively, an evidence vacuum. More to the point, dispensary owners and investors seem uninterested in establishing a robust evidence base for cannabis outcomes. Given the range of conditions and symptoms presented by patients, to include the prevalence of multiple symptoms together with the range of potential cannabis formulations, dosing regimens and delivery options, a failure to monitor patients over the course of their exposure to cannabis in not acceptable. The purpose of this commentary is to report on a proposed on-line registry structure proposed by Prometheus Research for medical marijuana dispensaries in the US. The registry tracks and reports on patients over the course of treatment with botanical cannabis with the focus on severe or chronic non-cancer pain, severe nausea, persistent muscle spasms and seizures, together with prevalent comorbidities – fatigue, anxiety, depression and sleep. This is the first time a registry has been developed for dispensaries in the United States as a model for a robust evidence base to support botanical cannabis as a therapy option. Article Type: Commentary

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779. Impact of updated IDSA practice guidelines on the treatment of Clostridium difficile infections in the United States

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz360.847 ◽

2019 ◽

Vol 6 (Supplement_2) ◽

pp. S346-S346 ◽

Cited By ~ 1

Author(s):

Cornelius J Clancy ◽

Minh-Hong Nguyen

Keyword(s):

United States ◽

Practice Guidelines ◽

Randomized Clinical Trials ◽

The United States ◽

Prescription Data ◽

Recommended Treatment ◽

The Us ◽

Before And After ◽

Dosing Regimens ◽

National Pact

Abstract Background IDSA published updated practice guidelines for C. difficile infections (CDI) in February 2018. Since publication of previous CDI guidelines in2010, randomized clinical trials (RCTs) have demonstrated benefit of oral (po) vancomycin or fidaxomicin over metronidazole in at least some types of CDI. Updated guidelines endorsed vancomycin or fidaxomicin as recommended treatment for initial and recurrent nonfulminant CDI episodes, and vancomycin as treatment for fulminant CDI. We studied the use of po vancomycin, fidaxomicin and metronidazole in the United States before and after publication of updated guidelines. Methods We obtained US antibiotic prescription data (IQVIA, Durham, NC) since 2013, and used standard dosing regimens for treatment of initial CDI to estimate numbers of infections treated with different agents. Po vancomycin and fidaxomicin are used exclusively against known or suspected CDI. Metronidazole is used to treat CDI and other infections. IQVIA data do not capture indications for prescriptions. Results Treatment courses of po vancomycin and fidaxomicin increased by 45% (n = 126,729 increase) and 44% (n = 11,243 increase), respectively, over the 12 months after publication of the updated CDI guidelines compared with 12 months before publication (Figure, second arrow; Table). Increased use of both agents was evident in the first month after guidelines were published. Over the same 12 month periods, treatment courses of po metronidazole decreased by 3% (190,430 decrease). In comparison, treatment courses of po vancomycin increased by 24% (n = 47,219 increase) over the 12 months after publication of the multi-national PACT study in August 2014 (Figure, first arrow), which demonstrated superiority of vancomycin over metronidazole. Since 2013, there were no significant increases in the use of fidaxomicin until publication of the updated guidelines. Conclusion Updated IDSA guidelines have had a major impact on treatment of CDI in the US. RCT data used for guideline updates have been available since 2007–14 and 2011–12 for po vancomycin and fidaxomicin, respectively. IDSA should provide more timely updates to practice guidelines as new data emerge. Annual or bi-annual updates posted in electronic or other nontraditional formats may be more efficient than publishing long-form articles. Disclosures All authors: No reported disclosures.

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Abstract 19735: Temporal Trends in Sample Size of RCTs in Published Cardiology Literature from 1970-2013

Circulation ◽

10.1161/circ.130.suppl_2.19735 ◽

2014 ◽

Vol 130 (suppl_2) ◽

Author(s):

Sonia Jain ◽

Sushil A Luis ◽

Vivien Coelho ◽

Limor Ilan Bushari ◽

Hilma Holm ◽

...

Keyword(s):

Sample Size ◽

Randomized Clinical Trials ◽

Search Algorithm ◽

Temporal Trends ◽

Cost Effective ◽

Evidence Base ◽

Sample Sizes ◽

Study Designs ◽

Journal Impact ◽

Robust Evidence

Background: It is generally perceived that sample sizes of randomized clinical trials (RCTs) have increased over the years, particularly in specialties such as cardiology, with a robust evidence base. The aim of this study was to analyze temporal trends in sample sizes of RCTs in cardiology journals compared to other specialties. Methods: Abstracts of RCTs involving humans from PubMed for 1970-2013 were analyzed using a digital search algorithm. Sample sizes of studies were extracted from each abstract. Date of publication and journal name were collected. Journals from several medical subspecialties were selected for comparison, using the journal impact factor as a measure of clinical relevance. Sample sizes of studies in 1990 were compared to 2010 for each of the journals using the Mann-Whitney U test. Graphical comparisons of sample size trends are presented. Results: 272,054 abstracts of human RCTs were identified. Median sample sizes for the years 1990 and 2010 is shown in table 1. The median sample size for all RCTs published in Circulation was 99 subjects per study in 1990, increasing to 630 subjects per study in 2010 (p < 0.01). All cardiology journals had a significant increase in study sample size over the 20 year period, as did the multispecialty journals (JAMA, NEJM, Lancet). In contrast, only a few non-cardiology specialty journals published studies with increasing sample sizes (table 1). Figure 1 shows the sample size trend for 1970-2013. Conclusions: Our study demonstrates a dramatic temporal trend of increasing sample sizes in RCTs in cardiology compared to other specialties. Since sample size is estimated based on the effect size studied, one explanation for this observation is that the more obvious larger effects have been previously elucidated, leaving only smaller associations to be studied. This requires increasing resources, highlighting the importance of alternate study designs and collaborative registries to develop a cost effective evidence base.

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Medical Marijuana Dispensaries and Referrals for Child Maltreatment Investigations

Journal of Interpersonal Violence ◽

10.1177/0886260520912596 ◽

2020 ◽

pp. 088626052091259

Author(s):

Bridget Freisthler ◽

Christiana Kranich

Keyword(s):

Los Angeles ◽

Child Maltreatment ◽

Legal Status ◽

Medical Marijuana ◽

The United States ◽

Alcohol Outlet ◽

Alcohol Outlet Density ◽

Outlet Density ◽

Medical Marijuana Dispensaries ◽

Conditionally Autoregressive

The changing legal status of marijuana in the United States has increased access to the drug through medical marijuana dispensaries. Limited research exists that examines the effects of these dispensaries on social problems including child maltreatment. The current study examines how medical marijuana dispensaries may affect referrals for child abuse and neglect investigations. Data are analyzed from 2,342 Census tracts in Los Angeles County, California. Locations of medical marijuana dispensaries were obtained through Weedmaps.com . Using conditionally autoregressive models, local and spatially lagged dispensaries show a positive relationship to rates of referrals in the unadjusted models. However, when we adjust for alcohol outlet density and measures of social disorganization, this relationship is no longer significant. Although this study does not find a relationship between medical marijuana dispensaries and referrals for investigations of child maltreatment, it should not be considered a definitive finding of this relationship. The increasing number of states that are allowing marijuana to be used for medical and recreational purposes is resulting in more people using the drug and the effects on parenting are still unknown.

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Establishing Practice Risk Management and Outcomes Claims for Medical Marijuana Dispensaries: Questions Legislators Should Ask

INNOVATIONS in pharmacy ◽

10.24926/iip.v10i1.1596 ◽

2019 ◽

Vol 10 (1) ◽

pp. 1

Author(s):

Paul Langley

Keyword(s):

Risk Management ◽

Medical Marijuana ◽

Evidence Base ◽

Level Of Care ◽

Duty Of Care ◽

For Profit ◽

Not For Profit ◽

Article Type ◽

Scant Attention ◽

Medical Marijuana Dispensaries

In a previous commentary in INNOVATIONS in Pharmacy, the case was made that a major oversight in approving the establishment of medical marijuana programs through commercially and not-for-profit operated dispensaries is the failure to put in place standards for the monitoring and reporting of outcomes. It was pointed out that the evidence base is limited for the range of dosing options, administrative routes and conditions treated. The concern is that the ease that patients have in obtaining medical marijuana certification in many states means that a medical marijuana program is, in effect, little different from a recreational program. Dispensaries understandably focus on sales and returns to investors with scant attention given to tracking and reporting outcomes across the range of conditions and symptoms presented. While this no doubt appeals to investors in reducing administration costs, it makes it virtually impossible to deliver the appropriate and coordinated level of care that patients should expect if a medical marijuana dispensary is to meet it responsibilities in its duty of care. This places dispensaries at malpractice risk. Given this, this commentary focuses on the questions that legislators should ask in licensing medical marijuana dispensaries to ensure they meet a defensible duty of care to their patients. Article Type: Commentary

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HFrEF pharmacological treatment: hydralazine and isosorbide dinitrate

ESC CardioMed ◽

10.1093/med/9780198784906.003.0429 ◽

2018 ◽

pp. 1872-1877

Author(s):

Faraz S. Ahmad ◽

Clyde W. Yancy

Keyword(s):

Nitric Oxide ◽

Heart Failure ◽

Isosorbide Dinitrate ◽

Randomized Clinical Trials ◽

The United States ◽

Evidence Base ◽

Ongoing Research ◽

Reduced Ejection Fraction ◽

Nitrate Therapy ◽

Angiotensin Blockade

The use of hydralazine and isosorbide dinitrate in combination with renin–angiotensin blockade and evidence-based beta-blocker therapy is an accepted therapy for heart failure with reduced ejection fraction (HFrEF). However, differing assessments of the evidence base and the strength of recommendation are noted between the heart failure guideline writing committees in America and Europe, so much so that this may the largest digression of opinion between the two august groups. Three randomized clinical trials in the United States provide the cornerstone evidence for use of hydralazine and nitrates in selected patients with HFrEF. The explanation of the potential mechanism of action for combination hydralazine and nitrate therapy in certain HFrEF populations has shifted from a haemodynamic to a neurohormonal model based on better understanding of the role of nitric oxide and oxidative stress imbalances in the pathogenesis of HFrEF. The differing professional interpretations of the data and the unique cohort studied most avidly (i.e. those of African descent), have resulted in unusually low use of this regimen despite evident salutary benefits. Moreover, the available preparation requires thrice-daily dosing and important side effects limit its tolerability. The future of hydralazine and isosorbide dinitrate use in patients with HFrEF will be informed by ongoing research allowing for more precise alignment of treatment and response. Even more so, further research to explore how best to modulate nitric oxide in cardiovascular disease including the application of pharmacogenomics may expose new therapeutic directions in the treatment of heart failure.

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Blood Transfusion Trends in the United States, National Inpatient Sample, 2015-2018

Blood Advances ◽

10.1182/bloodadvances.2021005361 ◽

2021 ◽

Author(s):

Ruchika Goel ◽

Xianming Zhu ◽

Eshan U. Patel ◽

Elizabeth Patricia Crowe ◽

Paul M. Ness ◽

...

Keyword(s):

The United States ◽

Evidence Base ◽

National Inpatient Sample ◽

Pediatric Age Group ◽

Binomial Regression ◽

Therapeutic Procedures ◽

Admission Type ◽

National Trends ◽

Robust Evidence ◽

Inpatient Database

Blood transfusions are among the most common therapeutic procedures performed in hospitalized patients. This study evaluates contemporary national trends in RBC, plasma, platelet and cryoprecipitate transfusions. National Inpatient Sample (NIS), the largest all-payer inpatient database representing 94-97% of US population, was evaluated from the 4th quarter of 2015 through 2018. Quarterly trends for the percentage of hospitalizations with a transfusion procedure were separately examined for each blood product using log binomial regression and reported as quarterly percent change (QPC). The percentage of hospitalizations with a RBC transfusion decreased from 4.22% (2015Q4) to 3.79% (2018Q4) (QPC=-0.72[95%CI=-1.26, -0.19]; Ptrend=0.008). While plasma transfusions also decreased QPC=-1.33(95%CI=-2.00, 0.65;Ptrend<0.001), platelet transfusions remained stable QPC=-0.13[95%CI=-0.99,0.73]; Ptrend=0.766). In contrast, hospitalizations with cryoprecipitate utilization significantly increased QPC=2.01(95%CI=0.57,3.44; Ptrend=0.006). Significant quarterly reductions in RBC transfusions were also seen among many -but not all- strata of sex, race/ethnicity, patient risk-severity, and admission type (elective versus non-elective). Despite significant declines in RBC transfusions among older adults, there were no significant changes among pediatric age-group (<18-years) and those 18-49 years. The decline in RBC and plasma transfusions suggests steady incorporation of robust evidence base showing safety of restrictive transfusions. Increased cryoprecipitate use may be reflective of wider adoption of hypofibrinogenemia management and hemostasis testing for coagulopathic patients.

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RAND Retracts Report about Medical Marijuana Dispensaries and Crime

PsycEXTRA Dataset ◽

10.1037/e525412012-001 ◽

2011 ◽

Cited By ~ 1

Keyword(s):

Medical Marijuana ◽

Medical Marijuana Dispensaries

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A Subtle but Intractable Problem? Public Attitudes to Sectarianism in 2014

Scottish Affairs ◽

10.3366/scot.2015.0078 ◽

2015 ◽

Vol 24 (3) ◽

pp. 266-287 ◽

Cited By ~ 4

Author(s):

Rachel Ormston ◽

John Curtice ◽

Stephen Hinchliffe ◽

Anna Marcinkiewicz

Keyword(s):

Public Opinion ◽

Public Attitudes ◽

Evidence Base ◽

Social Attitudes ◽

The Public ◽

Public Beliefs ◽

Intractable Problem ◽

Robust Evidence

Discussion of sectarianism often focuses on evidence purporting to show discriminatory behaviour directed at Catholics or Protestants in Scotland. But attitudes also matter – in sustaining (or preventing) such discriminatory behaviours, and in understanding the nature of the ‘problem of sectarianism’ from the perspective of the Scottish public. This paper uses data from the Scottish Social Attitudes survey 2014. The survey fills a gap in the evidence base by providing robust evidence on what the public actually thinks about sectarianism in modern Scotland. It assesses public beliefs about the extent and nature of sectarianism and its perceived causes. Tensions in public opinion and differences in the attitudes of different sections of Scottish society are explored.

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The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

10.2196/preprints.17630 ◽

2019 ◽

Author(s):

Allison Hirsch ◽

Mahip Grewal ◽

Anthony James Martorell ◽

Brian Michael Iacoviello

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Clinical Research ◽

Scoping Review ◽

Digital Technologies ◽

Good Clinical Practice ◽

The United States ◽

Clinical Trial Research ◽

Digital Methods ◽

Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

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