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      Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study

      research-article
      1 , 2 , , 3 , 3
      BMJ : British Medical Journal
      BMJ Publishing Group Ltd.

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          Abstract

          Objective To examine the use of qualitative approaches alongside randomised trials of complex healthcare interventions.

          Design Review of randomised controlled trials of interventions to change professional practice or the organisation of care.

          Data sources Systematic sample of 100 trials published in English from the register of the Cochrane Effective Practice and Organisation of Care Review Group.

          Methods Published and unpublished qualitative studies linked to the randomised controlled trials were identified through database searches and contact with authors. Data were extracted from each study by two reviewers using a standard form. We extracted data describing the randomised controlled trials and qualitative studies, the quality of these studies, and how, if at all, the qualitative and quantitative findings were combined. A narrative synthesis of the findings was done.

          Results 30 of the 100 trials had associated qualitative work and 19 of these were published studies. 14 qualitative studies were done before the trial, nine during the trial, and four after the trial. 13 studies reported an explicit theoretical basis and 11 specified their methodological approach. Approaches to sampling and data analysis were poorly described. For most cases (n=20) we found no indication of integration of qualitative and quantitative findings at the level of either analysis or interpretation. The quality of the qualitative studies was highly variable.

          Conclusions Qualitative studies alongside randomised controlled trials remain uncommon, even where relatively complex interventions are being evaluated. Most of the qualitative studies were carried out before or during the trials with few studies used to explain trial results. The findings of the qualitative studies seemed to be poorly integrated with those of the trials and often had major methodological shortcomings.

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          Most cited references10

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          Methods for exploring implementation variation and local context within a cluster randomised community intervention trial.

          Insignificant or modest findings in intervention trials may be attributable to poorly designed or theorised interventions, poorly implemented interventions, or inadequate evaluation methods. The pre-existing context may also account for the effects observed. A combination of qualitative and quantitative methods is outlined that will permit the determination of how context level factors might modify intervention effectiveness, within a cluster randomised community intervention trial to promote the health of mothers with new babies. The methods include written and oral narratives, key informant interviews, impact logs, and inter-organisational network analyses. Context level factors, which may affect intervention uptake, success, and sustainability are the density of inter-organisational ties within communities at the start of the intervention, the centrality of the primary care agencies expected to take a lead with the intervention, the extent of context-level adaptation of the intervention, and the amount of local resources contributed by the participating agencies. Investigation of how intervention effects are modified by context is a new methodological frontier in community intervention trial research.
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            Addiction

            In the United States, 21.6 million individuals older than 12 are diagnosed with abuse or dependence to drugs and/or alcohol each year [1]. Consequently, direct and indirect costs to society stemming from addiction total more than $700 billion annually in the United States alone [1]. Addiction to drugs and alcohol has long been recognized as a mental health disorder, appearing in some form in the Diagnostic and Statistical Manual of Mental Disorders (DSM) since its inception in 1952 [2]. However, only recently have non-drug addictions (e.g., food and behavioral addictions) begun to gain increased acceptance as potentially classifiable addictions, as emphasized by the American Psychiatric Association’s (APA) reclassification of pathological gambling into the Substance-Related and Addictive Disorders category in the recent DSM-5 [3]. Only a minority of individuals who drink alcohol, smoke, or use drugs develop pathological use. The same can be said of individuals who eat, gamble, play online video games, or engage in other behaviors that might become addictive. Even individuals who engage in heavy drinking or who are obese may not meet suggested criteria for pathological alcohol use or eating behavior. Furthermore, in lesser amounts, using alcohol, using drugs, or engaging in behaviors with addiction-like potential may provide benefits. Thus, a spectrum of use exists, begging the question of where to draw the line between heavy use and addictive use. Clinical definitions distinguish heavy from pathological use by a continuation of use despite adverse consequences and a presence of distress, but in practice, this distinction is often difficult to make. In exploring substances and behaviors with addictive potential, it is critical to obtain a multifaceted, unbiased understanding of how the substances and behaviors both benefit and harm individuals and society in order to best discover policies and treatments to address addiction. In this issue of the Yale Journal of Biology and Medicine, the editors present articles on a variety of topics related to addiction in order to provide an informative, well-rounded depiction of drug and alcohol use, maladaptive behaviors, and potential policies and treatments related to addiction. The editors have selected articles that highlight areas within addiction that are emerging in importance. Original research presented by Serafini and Stewart demonstrates the importance of perceptions of sibling’s alcohol use on the likelihood of drinking alcohol in young adults. Rutherford and colleagues also present original research, investigating the differences in brain structure between substance-using and non-substance-using mothers and how maternal substance use relates to general motivation. Often people have the mindset that any drug prescribed by a doctor in a medical setting is safe from addiction and abuse, but clinicians know otherwise. In this issue, Tetrault and Butner provide an overview of the increasing rates of non-medical prescription opioid use and the accompanying growing dangers of addiction and overdose. Hawk and colleagues review strategies aimed at reducing fatalities from opioid overdose, which are becoming more common in the United States from increased prescription opioid use. Weaver also describes misuse and abuse of prescription sedatives such as benzodiazepines. Additionally, drugs such as marijuana have been demonstrated to have potential medical uses despite being illegal to prescribe by physicians in most U.S. states. Hall reviews the policy changes that have been made with the increased adoption of medical marijuana in the United States. Sun and colleagues review the effectiveness and safety of the use of marijuana for treatment of glaucoma. Understanding the benefits of drugs of abuse is important for policy and prevention targeted toward reducing addiction. Smoking tobacco and obesity are the two leading causes of preventable death in the United States [4]. Annamalai reviews the importance of encouraging patients with serious mental illness to attempt smoking cessation, an important topic since the rates of smoking among people with serious mental illness remain much higher than the general population. Wickham reviews the biology of how menthol interacts with nicotine, which is an imperative line of research to study given the growing market for flavored electronic cigarettes. Rupprecht reviews the intersection and interrelation of the two health hazards of obesity and smoking. Additionally, Meule chronicles the history of food addiction research. An enhanced understanding of non-drug addictions is emerging in importance as the APA promotes researching more behavioral addictions for inclusion in the next edition of the DSM. In this vein, Szabo details the importance of coming to a common consensus about what constitutes a behavioral addiction as he discusses the particular case of exercise addiction. Xu and colleagues review the research on video game addiction and detail the associated risk of addiction when developing video games to treat amblyopia. Voss and colleagues describe a case report of pornography use-associated Internet Gaming Disorder, a behavioral addiction garnering increasing attention. Treatment development is another area of active investigation in the field of addiction, and several relevant articles are contained in this issue. Xu and colleagues describe a novel technique using transcranial direct current stimulation (tDCS) to increase activity in both sides of the prefrontal cortex, and the authors discuss the potential for treating addiction using tDCS intervention. Melemis offers his perspective on maintaining recovery from addiction using five rules to avoid relapse. Heshmat describes recovery from addiction from a behavioral economics perspective, offering his insight into how best to achieve abstinence. Additionally, Robertson-Boersma and colleagues discuss the potential for peer intervention to reduce binge alcohol drinking in college students. It is crucial for society to continue to increase its understanding of addiction to drugs, alcohol, and behaviors in order to establish improved behavioral and pharmacological treatments for addiction. Additionally, continued unbiased discussion about addiction will allow society to develop and implement effective public policy that balances both the detrimental and beneficial effects of drugs, alcohol, and addictive behaviors. Lastly, additional research into non-drug addictions is essential in order that a valid and reliable diagnostic system can be created to better identify and treat addictions to food, exercise, video games, etc. in a clinical setting. The articles presented in this issue aim to advance society one step further in its knowledge and understanding of addiction.
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              The OFF theory of research utilization.

                Author and article information

                Contributors
                Role: senior lecturer
                Role: senior researcher
                Role: senior researcher
                Journal
                BMJ
                bmj
                BMJ : British Medical Journal
                BMJ Publishing Group Ltd.
                0959-8138
                1468-5833
                2009
                2009
                10 September 2009
                : 339
                : b3496
                Affiliations
                [1 ]Department of Public Health and Policy, London School of Hygiene and Tropical Medicine, London WC1E 7HT
                [2 ]Health Systems Research Unit, Medical Research Council of South Africa
                [3 ]Norwegian Knowledge Centre for the Health Services, Oslo, Norway
                Author notes
                Correspondence: S Lewin simon.lewin@ 123456nokc.no
                Article
                lews609891
                10.1136/bmj.b3496
                2741564
                19744976
                c520cbc0-fe1c-456f-8568-5888bfe4e9bc

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

                History
                : 28 January 2009
                Categories
                Research
                Clinical trials (epidemiology)

                Medicine
                Medicine

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