scholarly journals Cannabidiol use and effectiveness: real-world evidence from a Canadian medical cannabis clinic

2021 ◽  
Vol 3 (1) ◽  
Author(s):  
Lucile Rapin ◽  
Rihab Gamaoun ◽  
Cynthia El Hage ◽  
Maria Fernanda Arboleda ◽  
Erin Prosk
Keyword(s):  
Observational Study ◽  
Real World ◽  
Retrospective Observational Study ◽  
Depression Symptoms ◽  
Medical Cannabis ◽  
Specific Symptom ◽  
Pain Anxiety ◽  
Real World Evidence ◽  
Anxiety Depression ◽  
The Impact

Abstract Background Cannabidiol (CBD) is a primary component in the cannabis plant; however, in recent years, interest in CBD treatments has outpaced scientific research and regulatory advancement resulting in a confusing landscape of misinformation and unsubstantiated health claims. Within the limited results from randomized controlled trials, and lack of trust in product quality and known clinical guidelines and dosages, real-world evidence (RWE) from countries with robust regulatory frameworks may fill a critical need for patients and healthcare professionals. Despite growing evidence and interest, no real-world data (RWD) studies have yet investigated patients’ reports of CBD impact on symptom control in the common expression of pain, anxiety, depression, and poor wellbeing. The objective of this study is to assess the impact of CBD-rich treatment on symptom burden, as measured with a specific symptom assessment scale (ESAS-r). Methods This retrospective observational study examined pain, anxiety, depression symptoms, and wellbeing in 279 participants over 18 years old, prescribed with CBD-rich treatment at a network of clinics dedicated to medical cannabis in Quebec, Canada. Data were collected at baseline, 3 (FUP1), and 6 (FUP2) month after treatment initiation. Groups were formed based on symptom severity (mild vs moderate/severe) and based on changes to treatment plan at FUP1 (CBD vs THC:CBD). Two-way mixed ANOVAs were used to assess ESAS-r scores differences between groups and between visits. Results All average ESAS-r scores decreased between baseline and FUP1 (all ps < 0.003). The addition of delta-9-tetrahydrocannabinol (THC) during the first follow-up had no effect on symptom changes. Patients with moderate/severe symptoms experienced important improvement at FUP1 (all ps < 0.001), whereas scores on pain, anxiety, and wellbeing of those with mild symptoms actually increased. Differences in ESAS-r scores between FUP1 and FUP2 were not statistically different. Conclusion This retrospective observational study suggests CBD-rich treatment has a beneficial impact on pain, anxiety, and depression symptoms as well as overall wellbeing only for patients with moderate to severe symptoms; however, no observed effect on mild symptoms. The results of this study contribute to address the myths and misinformation about CBD treatment and demand further investigation.

The impact of anti-CGRP monoclonal antibodies in resistant migraine patients: a real-world evidence observational study

2021 ◽  
Author(s):  
Marta Torres-Ferrús ◽  
Victor J. Gallardo ◽  
Alicia Alpuente ◽  
Edoardo Caronna ◽  
Eulalia Gine-Cipres ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Observational Study ◽  
Real World ◽  
Real World Evidence ◽  
The Impact

1607-P: Real-World Evidence of the Impact of Obesity on Residual Teeth in the Japanese Population

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 1607-P
Author(s):  
MAYU HAYASHI ◽  
KATSUTARO MORINO ◽  
KAYO HARADA ◽  
MIKI ISHIKAWA ◽  
ITSUKO MIYAZAWA ◽  
...  
Keyword(s):  
Real World ◽  
Japanese Population ◽  
Real World Evidence ◽  
The Impact

scholarly journals P237 Annual incidence and prevalence of ulcerative colitis and Crohn’s disease from 2010 to 2017 in four Nordic countries: Results from the TRINordic study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S261-S262
Author(s):  
M Lördal ◽  
J Burisch ◽  
E Langholz ◽  
T Knudsen ◽  
M Voutilainen ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Observational Study ◽  
Nordic Countries ◽  
Annual Incidence ◽  
University Hospital ◽  
Retrospective Observational Study ◽  
Western World ◽  
The Impact

Abstract Background Incidence and prevalence of inflammatory bowel diseases (IBD) have been increasing for the past decades in the western world, however with an emerging trend of incidence stabilisation in recent years. There is an indication of higher IBD incidence and prevalence in northern Europe, especially in the Nordic region, compared with southern Europe. Methods This retrospective observational study collected data from the National Patient Registries and National Prescription Registries (Sweden [SWE], Norway [NOR], Denmark [DEN]) and one university hospital database (Turku, Finland [FIN]) during 2010–2017 to investigate the annual incidence and prevalence of ulcerative colitis (UC) and Crohn’s disease (CD). Patients with ≥2 ICD-10 diagnosis codes for UC (K51) or CD (K50) from 2010 or later and no K51 or K50 codes prior to 2010 were included; patients were classified according to their last code. The look-back period for SWE was until 2000, for NOR until 2008, for DEN until 1995, and for FIN until 2004. Incidence proportions highlight results through 2016, as 2017 patients had less than 1-year follow-up. Results In total, 69,876 patients were included (SWE n = 27,902, NOR n = 20,761, FIN n = 2,118, DEN n = 19,095), of which 44 367 patients were diagnosed with UC and 25,509 with CD. In 2016, the annual incidence of UC was 28 patients per 100,000 persons in NOR, 32 patients per 100,000 persons in DEN, 25 patients per 100,000 persons in SWE, and 44 patients per 100,000 in FIN. The corresponding results for the annual incidence of CD per 100,000 persons were 22 in NOR, 16 in DEN, 16 in SWE, and 21 in FIN. The prevalence per 100,000 persons of both UC and CD was the highest in DEN, followed by SWE and NOR, and lowest in FIN. Prevalence estimates increased in all four Nordic countries during 2010–2017: for UC, from 409 to 488 patients in SWE, from 256 to 428 in NOR, from 129 to 375 in FIN, and from 577 to 798 in DEN. For CD, it increased from 261 to 313 patients in SWE, from 164 to 258 in NOR, from 54 to 164 in FIN, and from 280 to 400 in DEN. Conclusion This retrospective observational study showed that during 2016, the annual incidence of UC ranged from 25–44 patients per 100,000 persons across the evaluated Nordic countries, whereas the annual incidence of CD was 16–22 patients per 100,000 persons. Prevalence of both UC and CD increased during 2010–2017 in all four countries. Estimates of UC and CD incidence and prevalence in this analysis are greater than reported in the published literature. Additional analyses are underway to further explore the impact of methodological decisions on the estimates of UC and CD annual incidence and prevalence.

scholarly journals Connected health for growth hormone treatment research and clinical practice: learnings from different sources of real-world evidence (RWE)—large electronically collected datasets, surveillance studies and individual patients’ cases

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Nea Boman ◽  
Luis Fernandez-Luque ◽  
Ekaterina Koledova ◽  
Marketta Kause ◽  
Risto Lapatto
Keyword(s):  
Growth Hormone ◽  
Observational Study ◽  
Case Studies ◽  
Real World ◽  
Growth Disorders ◽  
Injection Device ◽  
Growth Outcomes ◽  
Real World Evidence ◽  
High Adherence

Abstract Background A range of factors can reduce the effectiveness of treatment prescribed for the long-term management of chronic health conditions, such as growth disorders. In particular, prescription medications may not achieve the positive outcomes expected because approximately half of patients adhere poorly to the prescribed treatment regimen. Methods Adherence to treatment has previously been assessed using relatively unreliable subjective methods, such as patient self-reporting during clinical follow-up, or counting prescriptions filled or vials returned by patients. Here, we report on a new approach, the use of electronically recorded objective evidence of date, time, and dose taken which was obtained through a comprehensive eHealth ecosystem, based around the easypod™ electromechanical auto-injection device and web-based connect software. The benefits of this eHealth approach are also illustrated here by two case studies, selected from the Finnish cohort of the easypod™ Connect Observational Study (ECOS), a 5-year, open-label, observational study that enrolled children from 24 countries who were being treated with growth hormone (GH) via the auto-injection device. Results Analyses of data from 9314 records from the easypod™ connect database showed that, at each time point studied, a significantly greater proportion of female patients had high adherence (≥ 85%) than male patients (2849/3867 [74%] vs 3879/5447 [71%]; P < 0.001). Furthermore, more of the younger patients (< 10 years for girls, < 12 years for boys) were in the high adherence range (P < 0.001). However, recursive partitioning of data from ECOS identified subgroups with lower adherence to GH treatment ‒ children who performed the majority of injections themselves at an early age (~ 8 years) and teenagers starting treatment aged ≥ 14 years. Conclusions The data and case studies presented herein illustrate the importance of adherence to GH therapy and how good growth outcomes can be achieved by following treatment as described. They also show how the device, software, and database ecosystem can complement normal clinical follow-up by providing HCPs with reliable information about patient adherence between visits and also providing researchers with real-world evidence of adherence and growth outcomes across a large population of patients with growth disorders treated with GH via the easypod™ device.

Understanding the Users with Chronic Pain on AI CBT Mental Health App (Wysa): A Mixed-Methods Retrospective Observational Study (Preprint)

2021 ◽  
Author(s):  
S Meheli ◽  
Chaitali Sinha ◽  
Madhura Kabada
Keyword(s):  
Mental Health ◽  
Chronic Pain ◽  
Pain Management ◽  
Observational Study ◽  
Real World ◽  
Effect Size ◽  
Retrospective Observational Study ◽  
Medium Effect ◽  
Health Concerns ◽  
Perceived Needs

BACKGROUND Digital health interventions can bridge barriers in access to treatment of care for individuals with chronic pain. OBJECTIVE This study aimed to evaluate the perceived needs, engagement and the effectiveness of the mental health app Wysa on mental health outcomes among real-world users who reported chronic pain and engaged with the app for support. METHODS Real-world data from users (N = 2,194) who reported chronic pain and associated health conditions in their conversations with a mental health app was analyzed using a mixed-method retrospective observational study. An inductive thematic analysis was used to analyse conversational data of users with chronic pain to assess perceived needs, along with comparative macro-analyses of conversational flows to capture engagement within the app. Additionally, the scores from a subset of users who completed a set of pre-post assessment questionnaires, namely PHQ-9 (N=69) and GAD-7 (N=57), were examined to evaluate the effectiveness of Wysa in providing support for mental health concerns for those managing chronic pain. RESULTS The themes emerging from the conversations of users with chronic pain included Health Concerns, Socioeconomic Concerns, and Pain Management Concerns. Findings from the quantitative analysis indicated that users with chronic pain showed significantly greater app engagement (p value <2.2e-16) than users without chronic pain, with a large effect size (Vargha and Delaney’s A- 0.76 -0.8). Furthermore, the sample of users with pre-post assessments during the study period were found to have significant improvements in group means on both PHQ-9 and GAD-7 symptom scores, with medium effect size (Cohens’d, 0.6-0.61), respectively. CONCLUSIONS The findings indicate that users look for tools that can help them address their concerns related to mental health, pain management, and sleep issues. The study findings also indicate the breadth of needs for users with chronic pain and the lack of support structures, and suggests that Wysa can provide effective support to bridge the gap.

scholarly journals Real-world use of procalcitonin and other biomarkers among sepsis hospitalizations in the United States: A retrospective, observational study

PLoS ONE ◽  
2018 ◽  
Vol 13 (10) ◽  
pp. e0205924 ◽  
Author(s):  
Eric Gluck ◽  
H. Bryant Nguyen ◽  
Kishore Yalamanchili ◽  
Margaret McCusker ◽  
Jaya Madala ◽  
...  
Keyword(s):  
United States ◽  
Observational Study ◽  
Real World ◽  
The United States ◽  
Retrospective Observational Study
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