UK medical cannabis registry: a patient evaluation.

The UK Medical Cannabis Registry is the largest real world data platform for medical cannabis outcomes in the UK, providing insight into clinical outcomes and monitoring safety of this novel therapy. This study aims to assess the functionality and accessibility of the online data collection platform and patient priorities for future research. Descriptive statistics were used to analyze quantitative data. For open-ended questions an inductive thematic analysis was performed. 600 responses were recorded. 554 (92.3%) patients had used the platform. 272 (90.4%) patients believed it was easy to input medications. 52 (8.67%) patients recorded an adverse event with 38 (73.1%) finding it easy to record. 535 (96.6%) patients had completed health questionnaires with 490 (91.6%) patients finding this easy to do. 553 (92.2%) patients agreed that contributing to the registry would impact the medical care of future patients. 'Assessing the impact of medical cannabis on quality of life generally' was the top research priority for 357 (59.3%) patients. This study demonstrates that most enrolled patients found the platform easy to use and believed they were positively impacting future medical cannabis patient care. Future patient research priorities included assessment of quality of life and condition-specific outcomes

Patient priorities for research: A focus group study of UK medical cannabis patients

INTRODUCTION: There has yet to be an evaluation of medical cannabis patient preferences with respect to future research. As such, prioritisation of research agendas has been largely driven by academia and industry. The primary aim of this study was to elicit priorities for research from medical cannabis patients in the United Kingdom (UK). METHODS: Patients undergoing active treatment for health conditions with medical cannabis in the UK were invited to take part in focus groups from December 2021 to February 2022. An inductive thematic analysis of responses was performed. Participants also completed a ranking exercise whereby they assigned ten counters (each equivalent to £1 million GBP) to competing research priorities. RESULTS: 30 medical cannabis patients participated across 3 focus groups. The following themes were identified as research priorities: adverse events, comparison between cannabis-based medicinal products, health conditions, pharmacology of cannabis, types of study, healthcare professionals' attitudes, social environment, agriculture and manufacturing, and the cannabis plant. Participants assigned the highest proportion of research funding to 'assessment of effect on specific symptoms' (26 counters; 8.7%). CONCLUSIONS: This study highlighted specific themes within which to focus future research on medical cannabis. Clinically, there was a directive towards ensuring that research is condition- or symptom-specific. Participants also emphasised themes on the social impact of medical cannabis, such as knowledge of medical cannabis among healthcare professionals, stigma, and effects on driving and in the workplace. These findings can guide both research funders and researchers into effectively conducting research which fits within a more patient-centric model

Visual gaze patterns reveal surgeons' ability to identify risk of bile duct injury during laparoscopic cholecystectomy

BACKGROUND: Bile duct injury is a serious surgical complication of laparoscopic cholecystectomy. The aim of this study was to identify distinct visual gaze patterns associated with the prompt detection of bile duct injury risk during laparoscopic cholecystectomy. METHODS: Twenty-nine participants viewed a laparoscopic cholecystectomy that led to a serious bile duct injury ('BDI video') and an uneventful procedure ('control video') and reported when an error was perceived that could result in bile duct injury. Outcome parameters include fixation sequences on anatomical structures and eye tracking metrics. Surgeons were stratified into two groups based on performance and compared. RESULTS: The 'early detector' group displayed reduced common bile duct dwell time in the first half of the BDI video, as well as increased cystic duct dwell time and Calot's triangle glances count during Calot's triangle dissection in the control video. Machine learning based classification of fixation sequences demonstrated clear separability between early and late detector groups. CONCLUSION: There are discernible differences in gaze patterns associated with early recognition of impending bile duct injury. The results could be transitioned into real time and used as an intraoperative early warning system and in an educational setting to improve surgical safety and performance

Medical cannabis, CBD wellness products and public awareness of evolving regulations in the United Kingdom

Background: In the UK, legislation and regulations governing medical cannabis and over the counter cannabidiol (CBD) wellness products have rapidly evolved since 2018. This study aimed to assess the public awareness of the availability, regulations, and barriers to access medical cannabis and over the counter CBD wellness products. Methods: A cross-sectional survey study was performed through YouGov® using quota sampling methodology between March 22nd and March 31st 2021. Responses were matched and statistically weighted to UK adult population demographics, including those without internet access, and analysed according to percentage of respondents. Statistical significance was defined by p-value < 0.050. Results: Ten thousand six hundred eighty-four participants completed the survey. 5,494 (51.4%) respondents believed that medical cannabis is legal in the UK. 684 (6.4%) participants consumed CBD for wellness reasons, 286 (2.7%) were prescribed CBD for a medical reason and 222 (2.1%) consumed CBD for another reason. 10,076 (94.3%) respondents were unaware of April 2021 regulations meaning that all over the counter CBD wellness products in the UK must conform to European Novel Foods Regulations. The most frequently reported main barriers to accessing medical cannabis were its association with recreational cannabis (n = 2,686; 25.1%), being unsure if it was legal (n = 2,276; 21.3%) and being unsure what medical conditions its can be used for (n = 1,863; 17.4%). Conclusion: A large proportion of respondents are unaware of the legislation and regulations surrounding medical cannabis and over the counter CBD wellness products. Lack of knowledge may present a barrier to safe access to either product

Perceived stigma of patients undergoing treatment with cannabis-based medicinal products

Cannabis-based medicinal products (CBMPs) are prescribed with increasing frequency. This study aimed to investigate the perceived stigma attached to patients prescribed CBMPs in the UK to establish its prevalence. A qualitative survey was developed by an expert multidisciplinary group and data were collected via Qualtrics. In total, 2319 patients on CBMP therapy were invited to take part in this study. 450 (19.4%) participants completed the questionnaire. In total, 81.3% (n = 366), 76.9% (n = 346), and 61.3% (n = 276) of participants reported feeling very comfortable or comfortable telling friends, family, and medical professionals, respectively, about their treatment. Participants thought that friends (n = 372; 82.7%) and family (n = 339; 75.3%) were very approving or somewhat approving of their CBMP prescription. However, participants thought that only 37.8% (n = 170) of healthcare professionals and 32.9% (n = 148) of society in general were very approving or somewhat approving of their CBMP prescription. 57.1% (n = 257), 55.3% (n = 249), and 40.2% (n = 181) of participants were afraid of what the police or criminal justice system, other government agencies, and healthcare professionals might think about their treatment. This study highlights those patients treated with CBMPs experience a high prevalence of perceived stigma from many corners of society. Future work should be undertaken to explore strategies to reduce perceived stigma at an individual and community level to avoid discrimination of patients, likely increasing appropriate access

A Case Report on Longitudinal Collection of Tumour Biopsies for Gene Expression-Based Tumour Microenvironment Analysis from Pancreatic Cancer Patients Treated with Endoscopic Ultrasound Guided Radiofrequency Ablation.

BACKGROUND: Most patients with pancreatic ductal adenocarcinoma (PDAC) are metastatic at presentation with dismal prognosis warranting improved systemic therapy options. Longitudinal sampling for the assessment of treatment response poses a challenge for validating novel therapies. In this case study, we evaluate the feasibility of collecting endoscopic ultrasound (EUS)-guided longitudinal fine-needle aspiration biopsies (FNABs) from two PDAC patients and conduct gene expression studies associated with tumour microenvironment changes associated with radiofrequency ablation (RFA). METHODS: EUS-guided serial/longitudinal FNABs of tumour were collected before and after treatment from two stage III inoperable gemcitabine-treated PDAC patients treated with targeted RFA three times. Biopsies were analysed using a custom NanoString panel (144 genes) consisting of cancer and cancer-associated fibroblast (CAFs) subtypes and immune changes. CAF culture was established from one FNAB and characterised by immunofluorescence and immunoblotting. RESULTS: Two-course RFA led to the upregulation of the CD1E gene (involved in antigen presentation) in both patients 1 and 2 (4.5 and 3.9-fold changes) compared to baseline. Patient 1 showed increased T cell genes (CD4-8.7-fold change, CD8-35.7-fold change), cytolytic function (6.4-fold change) and inflammatory response (8-fold change). A greater than 2-fold upregulation of immune checkpoint genes was observed post-second RFA in both patients. Further, two-course RFA led to increased PDGFRα (4.5-fold change) and CAF subtypes B and C genes in patient 1 and subtypes A, B and D genes in patient 2. Patient 2-derived CAFs post-first RFA showed expression of PDGFRα, POSTN and MYH11 proteins. Finally, RFA led to the downregulation of classical PDAC subtype-specific genes in both patients. CONCLUSIONS: This case study suggests longitudinal EUS-FNAB as a potential resource to study tumour and microenvironmental changes associated with RFA treatment. A large sample size is required in the future to assess the efficacy and safety of the treatment and perform comprehensive statistical analysis of EUS-RFA-based molecular changes in PDAC

Gaze patterns hold key to unlocking successful search strategies and increasing polyp detection rate in colonoscopy

BACKGROUND:  The adenoma detection rate (ADR) is an important quality indicator in colonoscopy. The aim of this study was to evaluate the changes in visual gaze patterns (VGPs) with increasing polyp detection rate (PDR), a surrogate marker of ADR. METHODS:  18 endoscopists participated in the study. VGPs were measured using eye-tracking technology during the withdrawal phase of colonoscopy. VGPs were characterized using two analyses - screen and anatomy. Eye-tracking parameters were used to characterize performance, which was further substantiated using hidden Markov model (HMM) analysis. RESULTS:  Subjects with higher PDRs spent more time viewing the outer ring of the 3 × 3 grid for both analyses (screen-based: r = 0.56, P = 0.02; anatomy: r = 0.62, P < 0.01). Fixation distribution to the "bottom U" of the screen in screen-based analysis was positively correlated with PDR (r = 0.62, P = 0.01). HMM demarcated the VGPs into three PDR groups. CONCLUSION:  This study defined distinct VGPs that are associated with expert behavior. These data may allow introduction of visual gaze training within structured training programs, and have implications for adoption in higher-level assessment

Clinical outcome data of children treated with cannabis-based medicinal products for treatment resistant epilepsy - analysis from the UK medical cannabis registry.

BACKGROUND:  There is a paucity of high-quality evidence of the efficacy and safety of cannabis-based medicinal products in treatment of treatment-resistant epilepsy (TRE) in children. METHODS:  A case series of children (<18 years old) with TRE from the UK Medical Cannabis Registry was analyzed. Primary outcomes were ≥50% reduction in seizure frequency, changes in the Impact of Pediatric Epilepsy Score (IPES), and incidence of adverse events. RESULTS:  Thirty-five patients were included in the analysis. Patients were prescribed during their treatment with the following: CBD isolate oils (n = 19), CBD broad-spectrum oils (n = 17), and CBD/Δ9-THC combination therapy (n = 17). Twenty-three (65.7%) patients achieved a ≥50% reduction in seizure frequency. 94.1% (n = 16) of patients treated with CBD and Δ9-THC observed a ≥50% reduction in seizure frequency compared to 31.6% (n = 6) and 17.6% (n = 3) of patients treated with CBD isolates and broad-spectrum CBD products, respectively (p< 0.001). Twenty-six (74.3%) adverse events were reported by 16 patients (45.7%). The majority of these were mild (n = 12; 34.2%) and moderate (n = 10; 28.6%). CONCLUSION:  The results of this study demonstrate a positive signal of improved seizure frequency in children treated with Cannabis-based medicinal products (CBMPs) for TRE. Moreover, the results suggest that CBMPs are well-tolerated in the short term. The limitations mean causation cannot be determined in this open-label, case series

A cohort study comparing the effects of medical cannabis for anxiety patients with and without comorbid sleep disturbance.

BACKGROUND: Research on cannabis-based medicinal products (CBMPs) in anxiety remains inconclusive due to a paucity of high-quality evidence. Studies indicate a bidirectional relationship between generalized anxiety disorder (GAD) and sleep disruption, but it is unclear how this affects CBMP treatment outcomes. This study aims to compare the patient-reported outcome measures (PROMs) of patients prescribed CBMPs for GAD, with and without impaired sleep. METHODS: Changes in PROMs were recorded from baseline to 1, 3, 6, and 12 months between those with impaired or unimpaired sleep. Multivariate logistic regression was applied to compare factors associated with a clinically significant improvement in GAD-7 at 12 months. Secondary outcomes included adverse event incidence and frequency. RESULTS: Of the 302 patients that fit the inclusion criteria, mean GAD-7, single-item sleep quality, and EQ-5D-5L index values improved at all time points (p < 0.001). A relationship between sleep impairment and clinically significant changes in GAD-7 at 1 and 3 months was identified (p ≤ 0.01). On multivariate regression, only baseline GAD severity was associated with an increased likelihood of observing a clinically significant improvement in anxiety (p < 0.001). Seven hundred and seven (234%) adverse events were reported by 55 (18.21%) participants. CONCLUSIONS: This study observed an association between CBMP treatment and improvements in anxiety in patients with GAD. While patients with comorbid sleep disruption had greater improvements in anxiety, the differences were not maintained in a multivariate analysis. Baseline anxiety severity may be a predictor for CBMP treatment outcomes