Methodological challenges and actionable recommendations in studying the health effects of high-concentration THC products.

In conducting a scoping review on the health effects of high-concentration cannabis products, we have uncovered pervasive methodological shortcomings within the cannabis literature. This paper begins by defining the 'causal effect' of interest for public health and delineating the desirable features of study design that can address crucial questions pertaining to public health and policy. We further delve into the methodological complexities inherent in studying the health effects of high-concentration cannabis products, describing challenges associated with the measurement of exposures and outcomes, confounding, selection bias, and the generalizability of findings.

Enhancing Methodological Approaches for Studying Health Effects of High-Concentration THC Products.

For public health protection, informed decision-making relies on having a robust foundation of evidence concerning risks and their prevention. Application of an evidence-based framework depends on the availability of pertinent, scientifically sound data generated by well-directed and valid research endeavors. In this essay, we address the current state of research in humans and the evidential base concerning high-concentration delta-9-tetrahydrocannabinol (delta-9-THC) products, which are readily available in the United States.

"I never thought of it as payment": Qualitative evaluation of workshops with advanced practice registered nurses on pharmaceutical industry payment reporting.

Background: With the expansion of professional autonomy and prescriptive authority of advanced practice registered nurses (APRNs), interactions with industry are under greater scrutiny. As of July 1, 2021, pharmaceutical and medical device companies must publicly report all payments to APRNs through the Centers for Medicare and Medicaid Services' Open Payments website.

Purpose: To gauge APRNs' familiarity with, and perceptions of the Open Payments database and discuss whether and how APRNs should respond.

Paper mill challenges: past, present, and future.

Paper mills are fraudulent organizations that make money by writing fake manuscripts and offering authorship slots for sale to academic customers. Mill activity differs in scale to individual academic misconduct: many thousands of fake paper mill manuscripts have been successfully published in peer-reviewed journals. Despite this, paper mill activity is still relatively unrecognized outside the publishing industry.

The culture of care to enhance laboratory animal personnel well-being: a scoping review.

There has been intense focus on improving the quality of animal research in recent times. An emerging concept of a 'culture of care' has been proposed as another important pillar to enhance scientific quality, with staff well-being being a critical aspect. Professionals working with research animals can face moral and psychological burdens and are at risk of experiencing work-related stress.

A survey of experts to identify methods to detect problematic studies: stage 1 of the INveStigating ProblEmatic Clinical Trials in Systematic Reviews project.

Background And Objective: Randomized controlled trials (RCTs) inform health-care decisions. Unfortunately, some published RCTs contain false data, and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesize all RCTs which have been conducted on a given topic.

Experiences of early career researchers: Influences on the design and reporting of animal experiments, and the practical and emotional support needed to enhance best practice methods.

While best practice methodology in animal research aims to address reproducibility and translational issues, awareness and implementation remains low. Preclinical systematic reviews have highlighted many flaws, including issues with internal validity and reporting. With early career researchers (ECRs) heavily involved in all aspects of animal experiments, it is crucial we understand what shapes their research practices.

Quantifying Industry Spending on Promotional Events Using Open Payments Data.

Importance: Sponsorship of promotional events for health professionals is a key facet of marketing campaigns for pharmaceuticals and medical devices; however, there appears to be limited transparency regarding the scope and scale of this spending.

Objective: To develop a novel method for describing the scope and quantifying the spending by US pharmaceutical and medical companies on industry-sponsored promotional events for particular products.

Design And Setting: This was a cross-sectional study using records from the Centers for Medicare & Medicaid's Open Payments database on payments made to prescribing clinicians from January 1 to December 21, 2022.

Randomised study of the effects of sense of entitlement and conflict of interest contrarianism on researcher decision-making to work with the alcohol industry.

Background: It is well established that the tobacco industry used research funding as a deliberate tactic to subvert science. There has been little wider attention to how researchers think about accepting industry funding. We developed, then tested, hypotheses about two psychological constructs, namely, entitlement and conflict of interest contrarianism (CoI-C) among alcohol researchers who had previously received industry funding.

Cross-sectional examination of commercial milk formula industry funding of international, regional and national healthcare professional associations: protocol.

Introduction: Commercial milk formula manufacturers often emphasise their role in supporting infant and young child nutrition and breastfeeding, but their commercial goals to increase volume and profit margin of formula sales conflict with these declarations. Healthcare professional associations have an important role in healthcare worker education, shaping clinical practice. When healthcare professional associations enter into financial relationships with formula manufacturers, conflicts of interest arise, which may undermine education and practice that promotes optimal infant and young child feeding.

A survey of experts to identify methods to detect problematic studies: Stage 1 of the INSPECT-SR Project.

Background: Randomised controlled trials (RCTs) inform healthcare decisions. Unfortunately, some published RCTs contain false data, and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs which have been conducted on a given topic.

Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions.

Introduction: Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic.

Investigation of bias due to selective inclusion of study effect estimates in meta-analyses of nutrition research.

We aimed to explore, in a sample of systematic reviews (SRs) with meta-analyses of the association between food/diet and health-related outcomes, whether systematic reviewers selectively included study effect estimates in meta-analyses when multiple effect estimates were available. We randomly selected SRs of food/diet and health-related outcomes published between January 2018 and June 2019. We selected the first presented meta-analysis in each review (index meta-analysis), and extracted from study reports all study effect estimates that were eligible for inclusion in the meta-analysis.

Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials: a meta-epidemiological study.

Background: Researchers and decision-makers often use evidence from randomised controlled trials (RCTs) to determine the efficacy or effectiveness of a treatment or intervention. Studies with observational designs are often used to measure the effectiveness of an intervention in 'real world' scenarios. Numerous study designs and their modifications (including both randomised and observational designs) are used for comparative effectiveness research in an attempt to give an unbiased estimate of whether one treatment is more effective or safer than another for a particular population.

Obesity intervention evidence synthesis: Where are the gaps and which should we address first?

Health professionals and policymakers rely on evidence synthesized from high quality research studies. Yet, there remain unanswered questions about how to prevent and treat obesity. In this research project, international practice guidelines and Cochrane systematic reviews were examined in order to identify gaps in the synthesized obesity intervention evidence base.

Characteristics of Advanced Practice Nurses Receiving Top Industry Payments and Their Practice Settings: a Cross-sectional Study.

Background: The pharmaceutical industry promotes prescribing through the cultivation of key opinion leaders. Advanced practice nurses (APNs) are a growing and influential group of prescribers across generalist and specialty practice. Public reporting of industry payments to APNs allows for exploration of their influence within practice settings.

Context matters: using an Evidence to Decision (EtD) framework to develop and encourage uptake of opioid deprescribing guideline recommendations at the point-of-care.

Objectives: To describe the development and use of an Evidence to Decision (EtD) framework when formulating recommendations for the Evidence-Based Clinical Practice Guideline for Deprescribing Opioid Analgesics.

Study Design And Setting: Evidence was derived from an overview of systematic reviews and qualitative studies conducted with healthcare professionals and people who take opioids for pain. A multidisciplinary guideline development group conducted extensive EtD framework review and iterative refinement to ensure that guideline recommendations captured contextual factors relevant to the guideline target setting and audience.

Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions.

Introduction: Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic.

Understanding the Dynamics of More Restrictive Medicines Policy: A Case Study of Codeine Up-Scheduling in Australia.

Background: There has been increasing concern over opioid-related harms across the world. In Australia in 2018, codeine-containing products were up-scheduled from over-the-counter access at pharmacies, to requiring a prescription. The drug regulator's decision to up-schedule was contentious and widely debated, due to the potentially large impact on consumers and healthcare professionals.

Proposed methods for evaluating efforts made by governments to prevent and mitigate corporate influence and conflicts of interest in public health policy.

There is evidence that corporations try to delay, weaken, and avoid the adoption of measures that would protect and improve population health. This is particularly true and problematic for health harming industries, such as those producing ultra-processed foods, alcohol, and cigarettes. Financial conflicts of interest (COI) are also problematic in policy-making because they may compromise decision-makers' loyalty and independent judgment.

Clinical practice guideline for deprescribing opioid analgesics: summary of recommendations.

Introduction: Long term opioids are commonly prescribed to manage pain. Dose reduction or discontinuation (deprescribing) can be challenging, even when the potential harms of continuation outweigh the perceived benefits. The Evidence-based clinical practice guideline for deprescribing opioid analgesics was developed using robust guideline development processes and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology, and contains deprescribing recommendations for adults prescribed opioids for pain.