It has been repeatedly shown that randomized controlled trials (RCTs) do not represent real-world patient populations; a recent systematic review showed that more than 70% of trials are not broadly representative, limiting external validity.1 Consequently, RCT-based conclusions can be true (high internal validity) but many are irrelevant for the real-world setting due to low external validity and generalizability. Evidence-based medicine has given pre-eminence to RCTs, and meta-analyses of RCTs graded as the highest evidence in medicine. Although RCTs are superior in certain situations, mainly for pharmacological intervention aiming to treat a single disease in an otherwise healthy patient population, their inherent reductionist setting can miss much of what is valuable in health—things that can only be captured in a more patient-centred approach.2 This over-reliance on a familiar tool, known as the law of the instrument or ‘Maslow's hammer’, has already been described in 1966: ‘I suppose it is tempting, if the only tool you have is a hammer, to treat everything as if it were a nail’.3 RCTs should consequently be used appropriately, as necessary evidence before acquiring real-world evidence in pharmacological interventions.4
As we realize that societal determinants and individual lifestyle choices—which are not easily evaluated in RCTs—will be the major determinants of health and well-being in the future, over-reliance on the RCT instrument holds the danger of limiting medical progress through ‘by design’ prioritization of pharmacological interventions. Virtual group consultations, able to utilise limited resources (health professionals) maximally and deliver efficient care5, are an example of an innovative intervention that cannot be evaluated in a classic RCT. But observational designs have well-recognised limitations, so modern intervention and trial types now available to us should be more widely used and further developed. These include stepped wedge designs, just-in-time adaptive interventions (JITAIs, sometimes referred to as ‘jedis’), (sequential) multi-randomisation trials, and ‘small data’ approaches.5-7 As innovative interventions spread at scale, we believe embedded evaluation should be prioritized through novel health technology assessment (HTA) or health service funding schemes, as they and other complex interventions are best studied in real-world conditions, despite a paucity of RCT data.9 New—and preferably collaborative to address global inequality—funding streams are needed like the recent initiative from the United Kingdom's National Institute for Health Research (NIHR) for varied research approaches in diverse populations.10 Only then can true variety be delivered to facilitate the robust healthcare system changes the syndemic h
{"title":"Diverse research designs are needed for population health: Lessons from Maslow","authors":"Marcus Schmitt-Egenolf, Fraser Birrell","doi":"10.1002/lim2.55","DOIUrl":"10.1002/lim2.55","url":null,"abstract":"<p>It has been repeatedly shown that randomized controlled trials (RCTs) do not represent real-world patient populations; a recent systematic review showed that more than 70% of trials are not broadly representative, limiting external validity.<span><sup>1</sup></span> Consequently, RCT-based conclusions can be true (high internal validity) but many are irrelevant for the real-world setting due to low external validity and generalizability. Evidence-based medicine has given pre-eminence to RCTs, and meta-analyses of RCTs graded as the highest evidence in medicine. Although RCTs are superior in certain situations, mainly for pharmacological intervention aiming to treat a single disease in an otherwise healthy patient population, their inherent reductionist setting can miss much of what is valuable in health—things that can only be captured in a more patient-centred approach.<span><sup>2</sup></span> This over-reliance on a familiar tool, known as the law of the instrument or ‘Maslow's hammer’, has already been described in 1966: ‘I suppose it is tempting, if the only tool you have is a hammer, to treat everything as if it were a nail’.<span><sup>3</sup></span> RCTs should consequently be used appropriately, as necessary evidence before acquiring real-world evidence in pharmacological interventions.<span><sup>4</sup></span></p><p>As we realize that societal determinants and individual lifestyle choices—which are not easily evaluated in RCTs—will be the major determinants of health and well-being in the future, over-reliance on the RCT instrument holds the danger of limiting medical progress through ‘by design’ prioritization of pharmacological interventions. Virtual group consultations, able to utilise limited resources (health professionals) maximally and deliver efficient care<span><sup>5</sup></span>, are an example of an innovative intervention that cannot be evaluated in a classic RCT. But observational designs have well-recognised limitations, so modern intervention and trial types now available to us should be more widely used and further developed. These include stepped wedge designs, just-in-time adaptive interventions (JITAIs, sometimes referred to as ‘jedis’), (sequential) multi-randomisation trials, and ‘small data’ approaches.<span><sup>5-7</sup></span> As innovative interventions spread at scale, we believe embedded evaluation should be prioritized through novel health technology assessment (HTA) or health service funding schemes, as they and other complex interventions are best studied in real-world conditions, despite a paucity of RCT data.<span><sup>9</sup></span> New—and preferably collaborative to address global inequality—funding streams are needed like the recent initiative from the United Kingdom's National Institute for Health Research (NIHR) for varied research approaches in diverse populations.<span><sup>10</sup></span> Only then can true variety be delivered to facilitate the robust healthcare system changes the syndemic h","PeriodicalId":74076,"journal":{"name":"Lifestyle medicine (Hoboken, N.J.)","volume":"3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/lim2.55","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46927591","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yi Yang Fei, Peter Anto Johnson, Noor A.L. Omran, Austin Mardon, John Christy Johnson
In this commentary, we strive to illustrate common misconceptions of the dopamine fasting fad that has become popular among wellness enthusiasts and purported by health gurus. Here, we review the proposed Dopamine fasting technique for managing behavioral addictions as proposed by California psychiatrist Dr. Cameron Sepah. We first summarize correct and incorrect interpretations of what Dopamine fasting involves. Next, we contextualize the role of dopamine as it relates to behavioral modification interventions for addiction. Particularly, we discuss the role of dopamine in behavioral addiction and the effectiveness of cognitive behavioral therapy (CBT) techniques for various addictions which are the basis of the proposed dopamine fasting technique. While we see potential for dopamine fasting to offer significant benefits to individuals, we highlight the limitation of the self-guided aspect of dopamine fasting, which could pose physical and emotional harm to individuals if the guideline is misinterpreted or misused as the sole treatment for severe disorders which require clinician input. Future studies should aim to assess not only the scientific efficacy of dopamine fasting as a potential treatment approach for behavioral addiction, but also the needs and well-being of individuals who seek self-directed treatment from popular media trends.
{"title":"Maladaptive or misunderstood? Dopamine fasting as a potential intervention for behavioral addiction","authors":"Yi Yang Fei, Peter Anto Johnson, Noor A.L. Omran, Austin Mardon, John Christy Johnson","doi":"10.1002/lim2.54","DOIUrl":"10.1002/lim2.54","url":null,"abstract":"<p>In this commentary, we strive to illustrate common misconceptions of the dopamine fasting fad that has become popular among wellness enthusiasts and purported by health gurus. Here, we review the proposed Dopamine fasting technique for managing behavioral addictions as proposed by California psychiatrist Dr. Cameron Sepah. We first summarize correct and incorrect interpretations of what Dopamine fasting involves. Next, we contextualize the role of dopamine as it relates to behavioral modification interventions for addiction. Particularly, we discuss the role of dopamine in behavioral addiction and the effectiveness of cognitive behavioral therapy (CBT) techniques for various addictions which are the basis of the proposed dopamine fasting technique. While we see potential for dopamine fasting to offer significant benefits to individuals, we highlight the limitation of the self-guided aspect of dopamine fasting, which could pose physical and emotional harm to individuals if the guideline is misinterpreted or misused as the sole treatment for severe disorders which require clinician input. Future studies should aim to assess not only the scientific efficacy of dopamine fasting as a potential treatment approach for behavioral addiction, but also the needs and well-being of individuals who seek self-directed treatment from popular media trends.</p>","PeriodicalId":74076,"journal":{"name":"Lifestyle medicine (Hoboken, N.J.)","volume":"3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/lim2.54","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42426930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Md. Shahgahan Miah, Md. Razib Mamun, S. M. Murshid Hasan, Md. Golam Faruk Sarker, Muhammad Salim Miah, Md. Gias Uddin Khan, Ashraful Kabir, Mohammad Ainul Haque, N. M. Rabiul Awal Chowdhury