[{"id":726,"title":"Withdrawal Confounding in Studies of The Pharmacological Management of Substance Use Disorders","sha":"43d5bd3e26e46dcff1c1b9d575762b85","user_id":null,"state":"published","body":"Recently, there has been greater emphasis on the management of “addiction” and substance use disorders with pharmacological treatments. For example, Medication-Assisted Treatments (MAT), such as methadone and buprenorphine for opioid dependence and disulfiram and naltrexone for alcoholism are increasingly utilized by providers. Replacement Therapies (RT) such as heroin for opioid dependence and a variety of patches, lozenges, and gums for nicotine dependence are also common. \r\n\r\nWhen studied in clinical trials MAT and RT are frequently compared with placebo. This is typically a welcome addition to study design. However, researchers need to take extra precautions when using placebo in substance use disorders. Opioids, alcohol, nicotine, and others (e.g. benzodiazepines, barbiturates) can cause intense withdrawal syndromes, that commonly arise upon cessation of use. This may impact the validity of findings (e.g. by breaking patient and/or clinician blinding; increasing the nocebo effect and attrition rates, and affecting patient compliance). \r\n\r\nAn \"active placebo\" should be employed where possible. Additionally, blinding assessment (for patient and clinician) should routinely be done throughout the study. Trialists may also consider comparing the study treatment with itself (at a lower dose) or reintroducing the original drug at a low enough dose to mitigate withdrawal effects, thus (potentially) preserving the blind. Failure to take withdrawal confounding into account, in any serious way, may distort the evidence-base of these drugs for substance use treatment.\r\n","created_at":"2020-04-24T03:07:09.184Z","updated_at":"2020-04-27T06:01:20.207Z","zenodo_id":3767449,"doi":"https://doi.org/10.5281/zenodo.3767449","subject":null,"tags":["addiction","substance use disorders","behavioral health","withdrawal","clinical trial design","methodology","confounding"],"vote_count":0,"view_count":1,"score":0.1,"deleted":false,"muted":false,"tweeted":false,"attachment_file_name":null,"attachment_content_type":null,"attachment_file_size":null,"attachment_updated_at":null},{"id":787,"title":"Statistical significance under low power: A Gettier case?","sha":"abea204c036a705dbc93b051008bf496","user_id":null,"state":"published","body":"Epistemologists and researchers alike are concerned with the conditions under which one can be said to possess knowledge. In philosophy there is a classic account of knowledge as being \"Justified True Belief\". Under this account, a person can only truly know something if they have a belief that is both justified and true (i.e. knowledge as JTB).\r\n\r\nFor example: An individual S *knows* a proposition P, iff (if and only if):\r\n\r\ni) S believes that P,\r\nii) P is true, and\r\niii) S is *justified* in believing that P.\r\n\r\nSo-called \"Gettier cases\" arise when an individual is justified in believing something to be true and yet would probably not be said to have knowledge because they only got the right answer as a result of ***luck***.\r\n\r\nI posit that some instances in classical (frequentist) statistics are analogous to Gettier cases: A researcher who performs a study with low power, in which the alternative hypothesis is true, AND who observes a significant p-value, could be considered to be \"lucky\", given the likelihood that they would've observed non-significant findings. Still, they have inferred from that the alternative hypothesis is true; despite the improbability of doing so. It is unclear whether or not this should be considered \"knowledge\", under JTB.","created_at":"2020-11-10T22:27:43.401Z","updated_at":"2021-01-10T02:06:01.305Z","zenodo_id":4281536,"doi":"https://doi.org/10.5281/zenodo.4281536","subject":null,"tags":["p-values","epistemology","gettier cases","justified true belief","knowledge","frequentist statistics"],"vote_count":1,"view_count":1,"score":1.1,"deleted":false,"muted":false,"tweeted":true,"attachment_file_name":null,"attachment_content_type":null,"attachment_file_size":null,"attachment_updated_at":null}]