"How do I keep this live in my mind?" Allied Health Professionals' perspectives of barriers and enablers to implementing good clinical practice principles in research: a qualitative exploration.

BACKGROUND: Allied health professionals (AHPs) engaged in research are expected to comply with Good Clinical Practice (GCP) principles to protect participant safety and wellbeing and enhance data integrity. Currently, few studies have explored health professionals' perceptions of implementing and adhering to GCP principles in research with none of these including AHPs. Such knowledge is vital to guide future interventions to increase adherence to GCP principles. This study aimed to identify the barriers and enablers AHPs experience when applying GCP principles to research conduct in a public hospital and health service, as well as their perceived support needs. METHODS: The study used a qualitative descriptive study approach guided by behaviour change theory. AHPs currently undertaking ethically approved research within a public health service in Queensland, Australia were interviewed to explore barriers and enablers to adherence to GCP principles and support needs, with interview questions guided by the Theoretical Domains Framework (TDF). The TDF was chosen as it allows for a systematic understanding of factors influencing implementation of a specific behaviour (i.e., GCP implementation) and can be used to inform tailored interventions. RESULTS: Ten AHPs across six professions were interviewed. Participants identified both enablers and barriers to implementing GCP across nine domains of the TDF and enablers across three additional domains. Examples of enablers included strong beliefs about the importance of GCP in increasing research rigour and participant safety (i.e. from TDF - beliefs about consequences); applying clinical skills and personal attributes when implementing GCP (i.e., skills), available training and support (i.e., environmental context and resources); and alignment with their moral sense to 'do the right thing' (i.e., professional identity). Barriers to GCP implementation were generally less commonly reported but included reduced time to implement GCP and a sense of 'red tape' (i.e., environmental context and resources), a lack of knowledge of GCP principles (i.e., knowledge) and a fear of making mistakes (i.e., emotions), and varying relevance to individual projects (i.e., knowledge). Suggestions for support were identified beyond training, such as physical resources (e.g., prescriptive checklists, templates and scripts), additional time, and regular one-on-one mentoring support. CONCLUSION: Findings suggest that while clinicians recognise the importance of GCP and want to implement it, they report barriers to its practical implementation. GCP training alone is unlikely to address these barriers to implementing GCP in daily practice. Findings suggest that GCP training may be more useful to AHPs when it is tailored to the allied heath context and supplemented with additional supports including check-ups from experienced researchers and access to prescriptive resources. Future research however is needed to investigate the effectiveness of such strategies.

Effects of cannabinoids in Amyotrophic Lateral Sclerosis (ALS) murine models: a systematic review and meta-analysis.

Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disorder that results from motor neuron damage. Cannabinoids have been proposed as treatments for ALS because of their anti-excitotoxicity, anti-oxidant and anti-inflammatory effects. Preclinical studies in mice models of ALS have been published using a range of cannabinoid formulations and doses. To date, there has been no rigorous evaluation of these trials to assess a potential cannabinoid treatment effect. This review and meta-analysis was undertaken to provide evidence for or against a treatment effect of cannabinoids in murine ALS models. Evidence of a treatment effect in mice may provide motivation for trials in human ALS. We identified a total of 10 studies; nine studies using cannabinoid treatment in transgenic SOD1-G93A ALS-model mice and one study in TDP-43 transgenic mice. Eight of the nine studies that used SOD1-G93A mice expressed similarly high copy numbers of the transgene while one study used a low-copy number line. Outcomes evaluated were survival time and disease progression. The latter was measured by motor function and bodyweight decline. Meta-analysis of the mean difference in survival time across the seven studies showed an increase in survival of 3.84 days (95% CI: 0.35-7.32 days; p = 0.031) for cannabinoid treated compared to control SOD1-G93A mice. It was not possible to conduct meta-analyses for motor function decline or weight loss. However, eight of nine studies reported significant improvements in measures of motor function decline and one reported non-significant improvements. Weight loss was significantly attenuated in four of five studies reporting this measure while the other study reported a non-significant attenuation. This review provides some evidence for the efficacy of cannabinoids in prolonging survival time in an ALS mouse model. A delay in disease progression is also suggested following cannabinoid treatment though it was not possible to consolidate the results from reviewed studies. However, studies have moderate to high risk of bias and are highly heterogeneous. Although this review provides some evidence to support the conduct of a cannabinoid trial in human ALS, more standardized studies on specific cannabinoids are necessary before supporting therapeutic potential of cannabinoids in treating patients with ALS. OPEN SCIENCE BADGES: This article has received a badge for *Preregistration* because the study was pre-registered at https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=89274. The complete Open Science Disclosure form for this article can be found at the end of the article. More information about the Open Practices badges can be found at https://cos.io/our-services/open-science-badges/. Read the Editorial Highlight for this article on page 168.

Effects of Cannabis in Parkinson's Disease: A Systematic Review and Meta-Analysis.

The legalization of cannabis in many countries has allowed many Parkinson's disease (PD) patients to turn to cannabis as a treatment. As such there is a growing interest from the PD community to be properly guided by evidence regarding potential treatment benefits of cannabis. This systematic review and meta-analysis aims to compile the best available evidence to help guide patients and their family, clinicians and researchers make informed decisions. A systematic search of the literature was conducted in June 2021. Five randomized controlled studies and eighteen non-randomized studies investigated cannabis treatment in PD patients. No compelling evidence was found to recommend the use of cannabis in PD patients. However, a potential benefit was identified with respect to alleviation of PD related tremor, anxiety, pain, improvement of sleep quality and quality of life. Given the relative paucity of well-designed randomized studies, there is an identified need for further investigation, particularly in these areas.