scholarly journals How Routinely Collected Data for Randomized Trials Provide Long-term Randomized Real-World Evidence

2018 ◽  
Vol 1 (8) ◽  
pp. e186014 ◽  
Author(s):  
Lars G. Hemkens
Author(s):  
Benedikt Fritzsching ◽  
Marco Contoli ◽  
Celeste Porsbjerg ◽  
Sarah Buchs ◽  
Julie Rask Larsen ◽  
...  

Diabetes Care ◽  
2017 ◽  
Vol 41 (1) ◽  
pp. 69-78 ◽  
Author(s):  
Olga Montvida ◽  
Jonathan Shaw ◽  
John J. Atherton ◽  
Frances Stringer ◽  
Sanjoy K. Paul

2021 ◽  
Author(s):  
Jason Douglas Edward Proulx ◽  
Julia W. Van de Vondervoort ◽  
Kiley Hamlin ◽  
John Helliwell ◽  
Lara Beth Aknin

Numerous laboratory studies suggest that engaging in prosocial action predicts greater psychological well-being, yet little work has examined whether kids (aged 5–12) experience these benefits in real-world community settings. In Study 1, we surveyed 24/25 students who completed their entire Grade 6 curriculum in a long-term care home alongside residents called “Elders.” We found that the meaning that kids derived from interacting with the Elders strongly predicted greater psychological well-being. In Study 2, we conducted a pre-registered field experiment with 238 kids who were randomly assigned to package essential items for disadvantaged children who were either demographically similar or dissimilar to them. Kids self-reported their happiness both pre- and post-intervention. While happiness increased from pre- to post-intervention, this change did not differ for kids who helped a similar or dissimilar recipient. These studies offer real-world evidence that engaging in prosocial action—over an afternoon or year—may enhance kids’ psychological well-being.


2020 ◽  
Author(s):  
Basel Abu-Jamous ◽  
Arseni Anisimovich ◽  
Janie Baxter ◽  
Lucy Mackillop ◽  
Marcela P Vizcaychipi ◽  
...  

Background: Hundreds of thousands of deaths have already been recorded for patients with the severe acute respiratory syndrome coronavirus (SARS-CoV-2; aka COVID-19). Understanding whether there is a relationship between comorbidities and COVID-19 positivity will not only impact clinical decisions, it will also allow an understanding of how better to define the long-term complications in the groups at risk. In turn informing national policy on who may benefit from more stringent social distancing and shielding strategies. Furthermore, understanding the associations between medications and certain outcomes may also further our understanding of indicators of vulnerability in people with COVID-19 and co-morbidities. Methods: Electronic healthcare records (EHR) from two London hospitals were analysed between 1st January and 27th May 2020. 5294 patients presented to the hospitals in whom COVID status was formally assessed; 1253 were positive for COVID-19 and 4041 were negative. This dataset was analysed to identify associations between comorbidities and medications, separately and two outcomes: (1) presentation with a COVID-19 positive diagnosis, and (2) inpatient death following COVID-19 positive diagnosis. Medications were analysed in different time windows of prescription to differentiate between short-term and long-term medications. All analyses were done with controls (without co-morbidity) matched for age, sex, and number of admissions, and a robustness approach was conducted to only accept results that consistently appear when the analysis is repeated with different proportions of the data. Results: We observed higher COVID-19 positive presentation for patients with hypertension (1.7 [1.3-2.1]) and diabetes (1.6 [1.2-2.1]). We observed higher inpatient COVID-19 mortality for patients with hypertension (odds ratio 2.7 [95% CI 1.9-3.9]), diabetes (2.2 [1.4-3.5]), congestive heart failure (3.1 [1.5-6.4]), and renal disease (2.6 [1.4-5.1]). We also observed an association with reduced COVID-19 mortality for diabetic patients for whom anticoagulants (0.11 [0.03-0.50]), lipid-regulating drugs (0.15 [0.04-0.58]), penicillins (0.20 [0.06-0.63]), or biguanides (0.19 [0.05-0.70]) were administered within 21 days after their positive COVID-19 test with no evidence that they were on them before, and for hypertensive patients for whom anticoagulants (0.08 [0.02-0.35]), antiplatelet drugs (0.10 [0.02-0.59]), lipid-regulating drugs (0.15 [0.05-0.46]), penicillins (0.14 [0.05-0.45]), or angiotensin-converting enzyme inhibitors (ARBs) (0.06 [0.01-0.53]) were administered within 21 days post-COVID-19-positive testing with no evidence that they were on them before. Moreover, long-term antidiabetic drugs were associated with reduced COVID-19 mortality in diabetic patients (0.26 [0.10-0.67]). Conclusions: We provided real-world evidence for observed associations between COVID-19 outcomes and a number of comorbidities and medications. These results require further investigation and replication in other data sets.


2021 ◽  
Author(s):  
Kyrian Ezendu ◽  
Askal Ali

BACKGROUND With the explosion of web 2.0 technology, patients have taken to the internet to share experiences about their health conditions and treatments. Online drug review portals currently allow patients to their experiences with drugs they used in managing their conditions. These data sources could be harnessed for patient-reported real-world evidence to understand the impact of drugs on the users. OBJECTIVE To understand patients’ opinions about long-term AOMs (phentermine-topiramate, orlistat, naltrexone-bupropion, lorcaserin, and liraglutide) through online patient-posted user reviews. To determine the frequency of occurrence of key obesity treatment outcomes and build a multi-label classification model for detecting key obesity outcome topics. METHODS We crawled drug.com, askaapatient.com, webmd.com, druglib.com, and extracted reviews posted by the users of long-term AOMs about their experience with the drugs. Next, we carried out a generic lexicon-based document-level sentiment analysis by matching the words in the reviews of each AOM with their polarity classes in the sentiment dictionary. We then calculated the scaled sentiment score to measure how averagely positive the patient’s opinion is towards the drugs. The frequencies of occurrence of weight, adverse effect, glycemic, blood pressure, lipidemic outcome topics in the posted reviews were analyzed. A Multi-label classification model for classifying obesity outcome related topics was built and tested. RESULTS Patients expressed the most positive opinion for lorcaserin with a scaled sentiment score of 0.139, followed by phentermine-topiramate with scaled sentiment score of 0.04. Orlistat and naltrexone-bupropion had scaled-sentiment scores of -0.008 and -0.02 respectively. Having a scaled sentiment score -0.036, liraglutide was the most negatively appraised long-term AOM by patients’ reviews. Comparing the frequency of occurrence of weight and cardiometabolic topic in the reviews, weight loss outcome was the dominant topic, occurring in 1585 reviews, adverse effect topic occurred in 1273 reviews, glycemic outcome topic occurred in 92 reviews, blood pressure outcome topic occurred in 72 reviews, lipidemic outcome topic occurred in 48 reviews and topic on pulse outcome occurred in 31 reviews. The Multi-label classification model trained with the patient-posted AOM reviews has F1 score of 0.98, 0.55, 0.67, 0.80, and 0.67 in predicting AOM-related weight loss, adverse effect, , glycemic, blood pressure, lipidemic and pulse topics respectively in free text form. CONCLUSIONS Sentiment analysis of patient-posted long-term AOM reviews could be useful in understanding patient‘s experience with long-term AOMs. Despite having being withdrawn for the market, lorcaserin was the most positively appraised long-term AOM followed by phentermine-topiramate, orlistat, naltrexone-bupropion, and liraglutide. The users of AOMs commented most on the weight and safety (adverse effects) outcomes of AOMs than cardio-metabolic outcomes of their treatments. Classification model trained with patient posted AOM reviews had a good performance in detecting efficacy and safety signals occurring in text documents. sentiments/opinions formed by obese and overweight patients from their experience with long-term AOMs could be used in demonstrating the values of the medications, as part of patient-reported real-world evidence.


2019 ◽  
Vol 35 (9) ◽  
pp. 805-809 ◽  
Author(s):  
Emiel van Trijffel ◽  
Rob A.B. Oostendorp ◽  
J.W. Hans Elvers

2017 ◽  
Vol 9 (1) ◽  
Author(s):  
Yotsapon Thewjitcharoen ◽  
Nalin Yenseung ◽  
Areeya Malidaeng ◽  
Soontaree Nakasatien ◽  
Phawinpon Chotwanvirat ◽  
...  

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