UK Medical Cannabis Registry: Assessment of clinical outcomes in patients with insomnia.

INTRODUCTION: The primary aim of this study was to assess changes in sleep-specific health-related quality of life (HRQoL) for those prescribed cannabis-based medicinal products (CBMPs) for insomnia. METHODS: A case series of UK patients with insomnia was analyzed. Primary outcomes were changes in the Single-Item Sleep-Quality Scale (SQS), Generalized Anxiety Disorder-7 (GAD-7), and EQ-5D-5L at up to 6 months from baseline. Statistical significance was identified as a p value < .050. RESULTS: 61 patients were included in the analysis. There was an improvement in the SQS from baseline at 1, 3, and 6 months (p < .001). There were also improvements in the EQ-5D-5L Index value and GAD-7 at 1, 3, and 6 months (p < .050). There were 28 (45.9%) adverse events recorded by 8 patients (13.1%). There were no life-threatening/disabling adverse events. CONCLUSION: Patients with insomnia experienced an improvement in sleep quality following the initiation of CBMPs in this medium-term analysis. Fewer than 15% of participants reported one or more adverse events. However, due to the limitations of the study design, further investigation is required before definitive conclusions can be drawn on the efficacy of CBMPs in treating insomnia.

Assessment of clinical outcomes in patients with fibromyalgia: Analysis from the UK Medical Cannabis Registry.

INTRODUCTION: There are limited therapeutic options for individuals with fibromyalgia. The aim of this study is to analyze changes in health-related quality of life and incidence of adverse events of those prescribed cannabis-based medicinal products (CBMPs) for fibromyalgia. METHODS: Patients treated with CBMPs for a minimum of 1 month were identified from the UK Medical Cannabis Registry. Primary outcomes were changes in validated patient-reported outcome measures (PROMs). A p-value of <.050 was deemed statistically significant. RESULTS: In total, 306 patients with fibromyalgia were included for analysis. There were improvements in global health-related quality of life at 1, 3, 6, and 12 months (p < .0001). The most frequent adverse events were fatigue (n = 75; 24.51%), dry mouth (n = 69; 22.55%), concentration impairment (n = 66; 21.57%), and lethargy (n = 65; 21.24%). CONCLUSION: CBMP treatment was associated with improvements in fibromyalgia-specific symptoms, in addition to sleep, anxiety, and health-related quality of life. Those who reported prior cannabis use appeared to have a greater response. CBMPs were generally well-tolerated. These results must be interpreted within the limitations of study design.

UK medical cannabis registry: assessment of clinical outcomes in patients with headache disorders.

OBJECTIVES: Headache disorders are a common cause of disability and reduced health-related quality of life globally. Growing evidence supports the use of cannabis-based medicinal products (CBMPs) for chronic pain; however, a paucity of research specifically focuses on CBMPs' efficacy and safety in headache disorders. This study aims to assess changes in validated patient-reported outcome measures (PROMs) in patients with headaches prescribed CBMPs and investigate the clinical safety in this population. METHODS: A case series of the UK Medical Cannabis Registry was conducted. Primary outcomes were changes from baseline in PROMs (Headache Impact Test-6 (HIT-6), Migraine Disability Assessment (MIDAS), EQ-5D-5L, Generalized Anxiety Disorder-7 (GAD-7) questionnaire and Single-Item Sleep Quality Scale (SQS)) at 1-, 3-, and 6-months follow-up. P-values <0.050 were deemed statistically significant. RESULTS: Ninety-seven patients were identified for inclusion. Improvements in HIT-6, MIDAS, EQ-5D-5L and SQS were observed at 1-, 3-, and 6-months (p < 0.005) follow-up. GAD-7 improved at 1- and 3-months (p < 0.050). Seventeen (17.5%) patients experienced a total of 113 (116.5%) adverse events. CONCLUSION: Improvements in headache/migraine-specific PROMs and general health-related quality of life were associated with the initiation of CBMPs in patients with headache disorders. Cautious interpretation of results is necessary, and randomized control trials are required to ascertain causality.

Assessment of clinical outcomes in patients with post-traumatic stress disorder: analysis from the UK Medical Cannabis Registry.

BACKGROUND: The current paucity of clinical evidence limits the use of cannabis-based medicinal products (CBMPs) in post-traumatic stress disorder (PTSD). This study investigates health-related quality of life (HRQoL) changes and adverse events in patients prescribed CBMPs for PTSD. METHODS: A case-series of patients from the UK Medical Cannabis Registry was analyzed. HRQoL was assessed at 1-, 3-, and 6-months using validated patient reported outcome measures (PROMs). Adverse events were analyzed according to the Common Terminology Criteria for Adverse Events version 4.0. Statistical significance was defined as p < 0.050. RESULTS: Of 162 included patients, 88.89% (n = 144) were current/previous cannabis users. Median daily CBMP dosages were 5.00 (IQR: 0.00-70.00) mg of cannabidiol and 145.00 (IQR: 100.00-200.00) mg of Δ9-tetrahydrocannabinol. Significant improvements were observed in PTSD symptoms, sleep, and anxiety across all follow-up periods (p < 0.050). There were 220 (135.8%) adverse events reported by 33 patients (20.37%), with the majority graded mild or moderate in severity (n = 190, 117.28%). Insomnia and fatigue had the greatest incidence (n = 20, 12.35%). CONCLUSIONS: Associated improvements in HRQoL were observed in patients who initiated CBMP therapy. Adverse events analysis suggests acceptability and safety up to 6 months. This study may inform randomized placebo-controlled trials, required to confirm causality and determine optimal dosing.

Assessment of clinical outcomes of medicinal cannabis therapy for depression: analysis from the UK Medical Cannabis Registry.

BACKGROUND: Although pre-clinical experiments associate cannabinoids with reduced depressive symptoms, there is a paucity of clinical evidence. This study aims to analyze the health-related quality of life changes and safety outcomes in patients prescribed cannabis-based medicinal products (CBMPs) for depression. METHODS: A series of uncontrolled cases from the UK Medical Cannabis Registry were analyzed. The primary outcomes were changes from baseline in the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), Sleep Quality Scale (SQS), and EQ-5D-5 L at 1, 3, and 6 months. Secondary outcomes included adverse events incidence. RESULTS: 129 patients were identified for inclusion. Median PHQ-9 at baseline was 16.0 (IQR: 9.0-21.0). There were reductions in PHQ-9 at 1-month (median: 8.0; IQR: 4.0-14.0; p < 0.001), 3-months (7.0; 2.3-12.8; p < 0.001), and 6-months (7.0; 2.0-9.5; p < 0.001). Improvements were also observed in GAD-7, SQS, and EQ-5D-5L Index Value at 1, 3, and 6 months (p < 0.050). 153 (118.6%) adverse events were recorded by 14.0% (n = 18) of participants, 87% (n = 133) of which were mild or moderate. CONCLUSION: CBMP treatment was associated with reductions in depression severity at 1, 3, and 6 months. Limitations of the study design mean that a causal relationship cannot be proven. This analysis provides insights for further study within clinical trial settings.

Depression is a highly prevalent mental health condition with approximately one in five people affected by at least one episode of depression in their lifetime. Two cardinal symptoms of depression are low mood and loss of interest. Since depression is such a debilitating condition, improving quality of life is an important part of treatment.Antidepressant medications are currently an important part of treating depression, but the variability in their effectiveness means that there is a need for alternative treatments. Medicinal cannabis, which contains certain chemicals from the cannabis plant, has received growing interest as a potential novel treatment for depression. Due to the lack of clinical studies on the use of medicinal cannabis to treat depression, this study aims to assess the effects of medicinal cannabis on quality of life in patients suffering from depression.The study included 129 patients treated with medicinal cannabis for depression at Sapphire Medical Clinics. The results showed that medicinal cannabis was associated with improvements in depression and anxiety symptoms, as well as health-related quality of life, and sleep quality after 1, 3, and 6 months of treatment. Although there were numerous adverse events in a small number of patients, most of these were mild or moderate. A major limitation is that this study cannot determine the extent to which medicinal cannabis is directly responsible for the improvements in depression symptoms that were observed. Future studies should focus on conducting clinical trials which can better evaluate the true treatment effects of medicinal cannabis for depression.

Comparison of surgeon gaze behaviour against objective skill assessment in laparoscopic cholecystectomy-a prospective cohort study.

BACKGROUND: Eye tracking technology may provide the basis of a novel, objective technical skill assessment in surgery. Past research has showed differences in the gaze patterns between expert and novice surgeons. The aim of this study was to investigate the relationship between gaze behaviors and technical skill during laparoscopic cholecystectomy as determined by objective assessment scores. METHODS: Gaze behaviors of surgeons performing laparoscopic cholecystectomies were mapped using wearable eye tracking apparatus. Two impartial surgeons retrospectively analyzed video footage of the procedure to perform Objective Structured Assessment of Technical Skill (OSATS) assessments. Primary endpoints were correlation between gaze behaviours (dwell time (%) and fixation frequency (count/s)) and OSATS scores. Dwell time was defined as the percentage of time spent fixating on particular visual areas of interest (AOI). Pearson's correlation coefficient was used to estimate the relationship between primary endpoints and AOIs. Statistical significance was set at p < 0.05. RESULTS: 13 procedures were analyzed. Throughout all operative segments, a negative correlation was present between operating theatre dwell time and OSATS scores (p < 0.05). During dissection of Calot's triangle, there was a strong positive correlation between laparoscopic screen dwell time and OSATS scoring [r = 0.655, p < 0.05]. Scrub nurse dwell time during dissection of Calot's triangle showed a strong negative correlation with OSATS scoring [r = -0.619, p < 0.05]. During dissection of gallbladder fossa, operating theatre fixation frequency negatively correlated against OSATS scores [r = -0.566, p < 0.05]. CONCLUSION: The results suggest a greater focus on significant visual stimuli alongside a lack of attention to non-essential stimuli during critical stages of the operative period is associated with greater technical skill. This aids the validation of eye tracking as an adjunct high-stakes technical skill assessment.

Force-Sensing Enhanced Simulation Environment (ForSense) for laparoscopic surgery training and assessment.

BACKGROUND: Excessive or inappropriate tissue interaction force during laparoscopic surgery is a recognized contributor to surgical error, especially for robotic surgery. Measurement of force at the tool-tissue interface is, therefore, a clinically relevant skill assessment variable that may improve effectiveness of surgical simulation. Popular box trainer simulators lack the necessary technology to measure force. The aim of this study was to develop a force sensing unit that may be integrated easily with existing box trainer simulators and to (1) validate multiple force variables as objective measurements of laparoscopic skill, and (2) determine concurrent validity of a revised scoring metric. METHODS: A base plate unit sensitized to a force transducer was retrofitted to a box trainer. Participants of 3 different levels of operative experience performed 5 repetitions of a peg transfer and suture task. Multiple outcome variables of force were assessed as well as a revised scoring metric that incorporated a penalty for force error. RESULTS: Mean, maximum, and overall magnitudes of force were significantly different among the 3 levels of experience, as well as force error. Experts were found to exert the least force and fastest task completion times, and vice versa for novices. Overall magnitude of force was the variable most correlated with experience level and task completion time. The revised scoring metric had similar predictive strength for experience level compared with the standard scoring metric. CONCLUSION: Current box trainer simulators can be adapted for enhanced objective measurements of skill involving force sensing. These outcomes are significantly influenced by level of expertise and are relevant to operative safety in laparoscopic surgery. Conventional proficiency standards that focus predominantly on task completion time may be integrated with force-based outcomes to be more accurately reflective of skill quality.

Consumer demand for surgical innovation: a systematic review of public perception of NOTES.

BACKGROUND: The full scope of benefits offered by NOTES over traditional laparoscopy, if any, is not yet fully clear. Perceived patient demand for truly "scarless surgery" is often referenced one of the driving factors in the continued development of this relatively new technique. The true scale of patient preference and demand for NOTES as a surgical technique is unknown. This review aims to summarise currently available literature on the topic of patient perceptions of NOTES to guide future development of the technique. METHODS: A comprehensive search of PubMed and Web of Science electronic databases was performed on 1st Jan 2014. To be considered for inclusion, articles were required to assess and report the perception of NOTES in a sample of laypersons (patients or general public). The primary endpoint assessed was acceptance or preference rates expressed by patients for NOTES procedures. Reasons given for preference or rejection of NOTES were recorded, as well as preferred access routes and any predicting factors of NOTES acceptance. RESULTS: Initial search returned 1,334 results, resulting in 15 articles included in final data synthesis. These polled a total of 4,420 subjects. Acceptance of NOTES ranged between 41 and 84 %. Compared to a laparoscopic approach, preference rates for NOTES ranged from 0 to 78 %. Reasons for preferring NOTES were largely centred on potentially reduced recovery time, complications (particularly with reference to hernias) and postoperative pain. Improved cosmesis also played a role, but was secondary to the above issues. Overall, study quality was poor. CONCLUSIONS: This review suggests significant public interest in NOTES and scarless surgery in general. Further research and consideration of differences in public perceptions across regions, countries and cultures are required.

Eye tracking for skills assessment and training: a systematic review.

BACKGROUND: The development of quantitative objective tools is critical to the assessment of surgeon skill. Eye tracking is a novel tool, which has been proposed may provide suitable metrics for this task. The aim of this study was to review current evidence for the use of eye tracking in training and assessment. METHODS: A systematic literature review was conducted in line with PRISMA guidelines. A search of EMBASE, OVID MEDLINE, Maternity and Infant Care, PsycINFO, and Transport databases was conducted, till March 2013. Studies describing the use of eye tracking in the execution, training or assessment of a task, or for skill acquisition were included in the review. RESULTS: Initial search results returned 12,051 results. Twenty-four studies were included in the final qualitative synthesis. Sixteen studies were based on eye tracking in assessment and eight studies were on eye tacking in training. These demonstrated feasibility and validity in the use of eye tracking metrics and gaze tracking to differentiate between subjects of varying skill levels. Several training methods using gaze training and pattern recognition were also described. CONCLUSIONS: Current literature demonstrates the ability of eye tracking to provide reliable quantitative data as an objective assessment tool, with potential applications to surgical training to improve performance. Eye tracking remains a promising area of research with the possibility of future implementation into surgical skill assessment.

A growing problem: implications of obesity on the provision of trauma care.

The incidences of both trauma and obesity are rapidly on the rise. Whilst dedicated trauma centres exist, these may not be equipped to manage obese and super-obese patients' unique medical and surgical demands. This review assesses the impact of trauma on the obese patient and the specialist considerations required in their management throughout pre-hospital, acute and inpatient phases of trauma care. Specific recommendations for the necessary infrastructure and equipment are made to ensure optimal care of the obese trauma patient. We also review evidence-based best practice in the assessment, diagnosis and treatment of this patient group. Only by addressing the unique needs of obese trauma patients with specialist education, equipment and infrastructure can optimal patient outcomes be assured.