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      Advantages and Limitations of Naturalistic Study Designs and Their Implementation in Alcohol Hangover Research

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          Abstract

          In alcohol hangover research, both naturalistic designs and randomized controlled trials (RCTs) are successfully employed to study the causes, consequences, and treatments of hangovers. Although increasingly applied in both social sciences and medical research, the suitability of naturalistic study designs remains a topic of debate. In both types of study design, screening participants and conducting assessments on-site (e.g., psychometric tests, questionnaires, and biomarker assessments) are usually equally rigorous and follow the same standard operating procedures. However, they differ in the levels of monitoring and restrictions imposed on behaviors of participants before the assessments are conducted (e.g., drinking behaviors resulting in the next day hangover). These behaviors are highly controlled in RCTs and uncontrolled in naturalistic studies. As a result, the largest difference between naturalistic studies and RCTs is their ecological validity, which is usually significantly lower for RCTs and (related to that) the degree of standardization of experimental intervention, which is usually significantly higher for RCTs. In this paper, we specifically discuss the application of naturalistic study designs and RCTs in hangover research. It is debated whether it is necessary to control certain behaviors that precede the hangover state when the aim of a study is to examine the effects of the hangover state itself. If the preceding factors and behaviors are not in the focus of the research question, a naturalistic study design should be preferred whenever one aims to better mimic or understand real-life situations in experimental/intervention studies. Furthermore, to improve the level of control in naturalistic studies, mobile technology can be applied to provide more continuous and objective real-time data, without investigators interfering with participant behaviors or the lab environment impacting on the subjective state. However, for other studies, it may be essential that certain behaviors are strictly controlled. It is, for example, vital that both test days are comparable in terms of consumed alcohol and achieved hangover severity levels when comparing the efficacy and safety of a hangover treatment with a placebo treatment day. This is best accomplished with the help of a highly controlled RCT design.

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          Most cited references31

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          Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review.

          Selective eligibility criteria of randomized controlled trials (RCTs) are vital to trial feasibility and internal validity. However, the exclusion of certain patient populations may lead to impaired generalizability of results. To determine the nature and extent of exclusion criteria among RCTs published in major medical journals and the contribution of exclusion criteria to the representation of certain patient populations. The MEDLINE database was searched for RCTs published between 1994 and 2006 in certain general medical journals with a high impact factor. Of 4827 articles, 283 were selected using a series technique. Trial characteristics and the details regarding exclusions were extracted independently. All exclusion criteria were graded independently and in duplicate as either strongly justified, potentially justified, or poorly justified according to previously developed and pilot-tested guidelines. Common medical conditions formed the basis for exclusion in 81.3% of trials. Patients were excluded due to age in 72.1% of all trials (60.1% in pediatric populations and 38.5% in older adults). Individuals receiving commonly prescribed medications were excluded in 54.1% of trials. Conditions related to female sex were grounds for exclusion in 39.2% of trials. Of all exclusion criteria, only 47.2% were graded as strongly justified in the context of the specific RCT. Exclusion criteria were not reported in 12.0% of trials. Multivariable analyses revealed independent associations between the total number of exclusion criteria and drug intervention trials (risk ratio, 1.35; 95% confidence interval, 1.11-1.65; P = .003) and between the total number of exclusion criteria and multicenter trials (risk ratio, 1.26; 95% confidence interval, 1.06-1.52; P = .009). Industry-sponsored trials were more likely to exclude individuals due to concomitant medication use, medical comorbidities, and age. Drug intervention trials were more likely to exclude individuals due to concomitant medication use, medical comorbidities, female sex, and socioeconomic status. Among such trials, justification for exclusions related to concomitant medication use and comorbidities were more likely to be poorly justified. The RCTs published in major medical journals do not always clearly report exclusion criteria. Women, children, the elderly, and those with common medical conditions are frequently excluded from RCTs. Trials with multiple centers and those involving drug interventions are most likely to have extensive exclusions. Such exclusions may impair the generalizability of RCT results. These findings highlight a need for careful consideration and transparent reporting and justification of exclusion criteria in clinical trials.
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            A psychoneuroimmunological review on cytokines involved in antidepressant treatment response.

            The literature exploring the role that cytokine functioning plays in the pathogenesis and treatment of depressive illness is reviewed. The review focuses on the influence of antidepressants on cytokines, and on how treatment response might be affected by genetic variants of cytokines. The authors systematically reviewed the scientific literature on the subject over the last 20 years, searching PubMed, PsychInfo, and Cochrane databases. Antidepressants modulate cytokine functioning, and these mechanisms appear to directly influence treatment outcome in depression. Antidepressants appear to normalize serum levels of major inflammatory cytokines, including interleukin (IL)-1beta, IL-6, tumor necrosis factor alpha (TNF-alpha), and interferon gamma (IFN-gamma). Antidepressants are postulated to modulate cytokine functioning through their effects on intracellular cyclic adenosyl monophosphate (cAMP), serotonin metabolism, the hypothalamo-pituitary-adrenocortical (HPA) axis or through a direct action on neurogenesis. Preliminary research shows that cytokine genotypes and functioning may be able to help predict antidepressant treatment response. Current literature demonstrates an association between antidepressant action and cytokine functioning in major depression. Improved understanding of the specific pharmacologic and pharmacogenetic mechanisms is needed. Such knowledge may serve to enhance our understanding of depression, leading to promising new directions in the pathology, nosology, and treatment of depression. Copyright (c) 2010 John Wiley & Sons, Ltd.
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              Development of a Definition for the Alcohol Hangover: Consumer Descriptions and Expert Consensus

              Up to now, there is no adequate definition of the alcohol hangover. The purpose of the current study was to develop a useful definition, and consensus among those who will use it in scientific publications. A survey was conducted among N=1099 social drinkers who recently had a hangover. They were asked to provide their definition of the alcohol hangover. Text mining and content analysis revealed 3 potential definitions. These were submitted to members of the Alcohol Hangover Research Group, who were asked to give their expert opinion on the proposed definitions. Taking into account their comments and suggestions, the following definition for the alcohol hangover was formulated: "The alcohol hangover refers to the combination of mental and physical symptoms, experienced the day after a single episode of heavy drinking, starting when blood alcohol concentration approaches zero."
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                Author and article information

                Journal
                J Clin Med
                J Clin Med
                jcm
                Journal of Clinical Medicine
                MDPI
                2077-0383
                06 December 2019
                December 2019
                : 8
                : 12
                : 2160
                Affiliations
                [1 ]Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Science, Division of Pharmacology, Utrecht University, 3584 CG Utrecht, The Netherlands; a.j.a.e.vandeloo@ 123456uu.nl
                [2 ]Institute for Risk Assessment Sciences (IRAS), Faculty of Veterinary Medicine, Utrecht University, 3584 CM Utrecht, The Netherlands
                [3 ]Centre for Human Psychopharmacology, Swinburne University, Melbourne VIC 3122, Australia andrew@ 123456scholeylab.com (A.S.)
                [4 ]Addiction and Mental Health Group, Department of Psychology, University of Bath, Bath BA2 7AY, UK; sa221@ 123456bath.ac.uk
                [5 ]Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden, 01307 Dresden, Germany; Ann-Kathrin.Stock@ 123456uniklinikum-dresden.de
                [6 ]Psychological Sciences Research Group, University of the West of England, Bristol BS16 1QY, UK; chris.alford@ 123456uwe.ac.uk
                [7 ]Education and Social Sciences, University of the West of Scotland, Paisley PA1 2BE, UK; Gillianbruce@ 123456gmail.com
                Author notes
                [* ]Correspondence: J.C.Verster@ 123456uu.nl ; Tel.: +31-30-253-6909
                Author information
                https://orcid.org/0000-0002-6455-2096
                https://orcid.org/0000-0002-0016-9151
                https://orcid.org/0000-0001-7113-4020
                https://orcid.org/0000-0001-8626-0521
                https://orcid.org/0000-0003-4484-5462
                https://orcid.org/0000-0003-0887-6958
                Article
                jcm-08-02160
                10.3390/jcm8122160
                6947227
                31817752
                ce087990-8609-4f36-9eb1-d0a572648e5b
                © 2019 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                : 02 November 2019
                : 05 December 2019
                Categories
                Perspective

                study design,naturalistic study,randomized controlled trial,alcohol,hangover,blinding,mobile technology

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