Background Executive functioning (EF) deficits are troubling for adolescents and young adults (AYAs) after cancer treatment. Found insideThe #1 guide to the principles and clinical applications of evidence-based medicine has just gotten better! Integrating Clinical Research into Epidemic Response: The Ebola Experience assesses the value of the clinical trials held during the 2014â€"2015 epidemic and makes recommendations about how the conduct of trials could be improved in the ... Found inside – Page 198A 2-arm, randomized, controlled trial of a motivational interviewing–based intervention to improve adherence to antiretroviral therapy (ART) among patients ... This book provides a practical guide to the design, analysis and interpretation of studies that use such outcomes. QoL outcomes tend to generate data with discrete, bounded and skewed distributions. A randomized controlled trial (or randomized control trial; RCT) is a type of scientific (often medical) experiment that aims to reduce certain sources of bias when testing the effectiveness of new treatments. General). Pragmatic RCTs assess effectiveness of available medicines, while explanatory RCTs assess efficacy of investigational medicines. Brief Summary: This study is a Randomized Controlled Trial (RCT) of Integrated and Cognitive Behavioral Therapy for HIV Prevention in Pretoria, South Africa. "IEA, International Epidemiological Association, Welcome Trust." Found inside – Page 154A 2–arm, randomized, controlled trial of a motivational interviewing-based intervention to improve adherence to antiretroviral therapy (ART) among patients ... Arm 3 is the same High-Ratio CBM program but with a component consisting of adherence promoting (AP) telephone calls from a study phone coach, from 1 to 4 total as needed. This design was pragmatically chosen to ensure that 1 team from each arm would admit patients daily. An arm in a study is a set of participant experiences. Compared with an observational study, randomization is an effective method to balance confounding factors between treatment groups and it can eliminate the … In the time since the publication of the first edition, the use of cluster randomised trials (CRTs) has increased substantially, which is reflected in the updates to this edition. An arm in a study is a set of participant experiences. A key issue in critically appraising studies is that, while it can be thought of in terms of being an academic exercise, … Addressing graduate students, practitioners, and researchers, Jack Kalbfleisch and Ross Prentice update their classic text with these and other current developments in the second edition of The Statistical Analysis of Failure Time Data. Objective Ivermectin has been suggested as a treatment for COVID-19.This randomised control trial was conducted to test the efficacy of Ivermectin in the treatment of mild and moderate COVID-19. Found inside"Every doctor should read this book."—JAMA Internal Medicine "[A]n excellent and realistic discussion of some of the horror stories that occur in medical practice . . . Consider a two-arm RCT in which p t represents the rate of a binary outcome in the treatment arm and p c represents the rate in the control arm. A major factor in the rapid advance of medical science over the past 50 years has been the development and refinement of the clinical research method known as the randomized controlled trial (RCT). This design incorporates no control arm. This design is usually utilized to determine pharmacokinetic properties of a new drug (Phase 1 trials). Uncontrolled trials are known to produce greater mean effect estimates than a controlled trial, thereby inflating the expectations from the intervention. The strength of the RCT lies in the process of randomisation that is unique to this type of epidemiological study design. One of these interventions is the standard of comparison or control. Apart from the interventions being compared, the two groups are treated and observed in … Consider a two-arm RCT in which p t p t represents the rate of a binary outcome in the treatment arm and p c p c represents the rate in the control arm. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data. 2 In the Childhood Obesity Project, a 2-arm, randomized trial was conducted of higher- vs. lower-protein formulas within the first year of life on the development of obesity. The second edition of this best-selling book has been thoroughly revised and expanded to reflect the significant changes and advances made in systematic reviewing. There is often a period in between called the washout period to avoid any carry-over effects. This text distinguishes itself with its accessible and broadcoverage of statistical design methods--the crucial building blocksof clinical trials and medical research. RCT’s are human experiments—the intervention is controlled by the investigator: patients & doctors don’t get to choose their therapy! 2 In the same population, settingand interventionversus comparator for RQ1, what is the effect in achieving an increase in the percentage achieving 3-month continu-ous tobacco smoking abstinence? Phase 1 trial) Courtesy: J Colford 2 OBJECTIVE: To compare the effectiveness of tibial nerve transcutaneous electrical nerve stimulation (TENS) for an overactive bladder, considering the sites of application and frequency of attendance. Found insidePraise for the Second Edition: "... this is a useful, comprehensive compendium of almost every possible sample size formula. The study was conducted in primary care clinics adhering to the Family Health Strategy (FHS) [] in São Paulo, Brazil.Each clinic provides comprehensive and continuous care … Use of the new “1‐stage” natural cubic spline model allowed, for the first time, pooling of experience in 2‐arm randomized controlled trials to characterize the dose‐response relationship between potassium supplementation and blood pressure (BP). The process of randomly assigning a trial participant to treatment or control arms is called “randomization”. » Evidence based medicine (EBM) toolkit » Learn EBM » Appraising 2-armed randomised controlled trials. Methods: The trial is a two-armed, parallel group, open label, stratified block randomized superiority trial. Initial dosing was done for first five patients in a staggered manner wherein after a patient was dosed, safety was monitored for 24-48 hours prior This edition includes brand-new chapters on acupuncture, homeopathy, and therapies for substance dependence and weight management. The chapter on polypharmacy and side effect management addresses the growing issue of drug-drug interactions. Tate DF, Jackvony EH, Wing RR. Found inside – Page 151The Reach Out to Enhance Wellness trial was a 2-arm randomized controlled trial comparing the effects of a home-based exercise and dietary weight loss ... Effects of Internet behavioral counseling on weight loss in adults at risk for type 2 diabetes: a randomized trial. Found inside2003;4(2):121–131. doi:10.1310/hct.2003.4.2.007 Golin CE, Earp J, Tien H-C, Stewart P. Porter C, Howie L. A 2-arm, randomized, controlled trial of a ... Obes Res 2004 Jun;12(6):1011-1018. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. The randomized controlled trial is the most rigorous and robust research method of determining whether a cause–effect relation exists between an intervention and an outcome. Leveraging external data is a topic that have recently received much attention. Introduction: Cooling the extremities during chemotherapy has been hypothesized to reduce neurotoxicity. Simplest definition: Individuals are allocated at random to receive one of several interventions (at least two total). METHODS: This multi-arm randomized controlled trial enrolled 137 adult women (61.0±9.0 years) with overactive bladder from a university hospital. This is a two-arm pilot study of a non-randomized, controlled cluster trial. In a traditional two-arm or multiarm trial, eligible patients are randomly assigned between control and all intervention regimens. One of them is the standard of comparison, which is traditionally referred to as the control group. RCT’s are usually comparative studies (“controlled” in the RCT) Uncontrolled trials can be done (e.g. Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial (MS-SMART): a multiarm phase IIb randomised, double-blind, placebo-controlled clinical trial comparing the efficacy of three neuroprotective drugs in secondary progressive multiple sclerosis. Each cluster receives two treatments, one after the other. • Results are assessed by comparing the outcome in the treatment group with that of the control … Each group in an RCT is called an “arm,” so that, for example, a two-arm study may compare an experimental treatment vs a control group, and these would then be referred to as the “treatment arm” and the “control arm,” respectively. Pragmatic randomized controlled trials (RCTs) mimic usual clinical practice and they are critical to inform decision-making by patients, clinicians and policy-makers in real-world settings. Is adaptive randomization always better than traditional fixed-schedule randomization? Which procedures should be used and under which circumstances? What special considerations are required for adaptive randomized trials? Establishing whether PA enhances neural activity among AYAs is warranted. Participants were seen at a screening visit 1- 2 weeks prior to beginning the dietary intervention. What is a randomized controlled trial? A Randomized Controlled Trial (RCT) is a type of scientific experiment that aims to reduce certain sources of bias when testing the effectiveness of new treatments and is accomplished by randomly allocating subjects to two or more groups, treating them differently, and then comparing them concerning a measured response. Different tools can be used to randomize (closed envelopes, computer generated sequences, random numbers). METHOD Design This was a two-arm cluster-randomized controlled effec-tiveness trial with random allocation of hospital clinics to A cluster randomised trial is a study design which randomises groups of participants to each arm of a study rather than individuals. The study was a parallel-2-arm randomized controlled trial carried out between June 2012 and November 2013. Randomized controlled trial: (RCT) A study in which people are allocated at random (by chance alone) to receive one of several clinical interventions. Multi-arm multi-stage trials. Found insidePraise for the First Edition “All medical statisticians involved in clinical trials should read this book…” - Controlled Clinical Trials Featuring a unique combination of the applied aspects of randomization in clinical trials with a ... We conducted a systematic review to assess the reporting of analyses in reports of randomized controlled trials (RCTs) with multiple arms. Randomized controlled trial (RCT) is considered as the gold standard for evaluating intervention or health care. A two-arm randomized, placebo controlled, double-blind trial was conducted in the Department of Physiology at the Khartoum University. This is a relatively simple trial with two arms: an intervention arm and a control arm. Appraising 2-armed randomised controlled trials. In this paper we adapt these approaches, originally introduced to augment single-arm studies with external data, for the augmentation of both arms of a randomized controlled trial (RCT) with external data. Two hundred and one elderly participants with very mild to mild dementia will be screened and randomized … Randomised controlled trials. These experiences are often, but not always unique treatments and interventions. It was designed as a randomized, controlled, two-arm, interventional, multicenter study [].The inclusion criteria were multiple trauma (injury of at least two body regions) with an injury severity score (ISS) ≥ 16, a femoral shaft fracture which can be treated in … Physical activity (PA) may enhance neural activity underlying EF among older adults affected by cancer. ECA, external control arm; RCT, randomized controlled trial. 2: Flow diagram of the progress through the phases of a parallel randomized trial of two groups [6] Randomized Controlled Field Trial: It is similar to an Randomized Controlled Clinical Trial except that the intervention is preventive and not therapeutic. The ALIFE trial is a three-armed parallel group study to establish … 1- Example of a Randomized Controlled Clinical Trial [7] Fig. The two study sites are Penn State University (PSU) College of Medicine and Massachusetts General Hospital (Mass. The primary outcome was the BMI z score at 6 y, and the treatment difference was assessed with the use of a linear regression without adjustment for covariates. Design Parallel, double blind, randomised, placebo controlled trial Setting: A tertiary care dedicated COVID-19 hospital in Bihar, India Participants Adult patients (> 18 years) admitted with mild … Multiple-arm randomized trials can be more complex in their design, data analysis, and result reporting than two-arm trials. Found inside – Page 28In retrospective trials lumbar drainage of cerebrospinal fluid has been shown ... This is a protocol for a 2-arm randomized controlled trial to compare an ... The traditional statistical approach considers two possible outcomes of the trial. This edition incorporates current research methodology—including molecular and genetic clinical research—and offers an updated syllabus for conducting a clinical research workshop. The BROAD study was a prospective, two-arm, parallel, superiority study run from August 2014 to initially February 2015 (subsequently extended). The overarching design is a mixed-methods action research approach, consisting of a multi-centre pragmatic parallel-arm randomised controlled trial (RCT) and realist evaluation, conducted in two phases. This is done when it would be difficult give a new treatment to an individual within a community or social group without it affecting the outcome in the standard care arm … METHODS: This multi-arm randomized controlled trial enrolled 137 adult women (61.0±9.0 years) with overactive bladder from a university hospital. This book establishes the theoretical foundations of a general methodology for multiple hypothesis testing and discusses its software implementation in R and SAS. The control may be a standard practice, a placebo ("sugar pill"), or no intervention at all. The propensity score-integrated approaches are a methodological innovation for this purpose. Randomized controlled trials (RCTs) play a fundamental role in establishing evidence on benefits of diet changes in nutrition. 2.Literarure showed both and more over Consecutive and purposive sampling for similar randomised controlled trial as well. A placebo-controlled RCT is considered medicine's most reliable method for … A randomized controlled trial (or randomized control trial; RCT) is a type of scientific (often medical) experiment that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by randomly allocating subjects to two or more groups, treating them differently, and Found inside – Page 198Results indicated a differential pattern of prediction in the 2 samples. ... This is a 2-arm, randomized controlled trial (N = 89) comparing CBT-AD with ... The primary aim of this cluster randomized controlled trial (RCT) is to compare the effectiveness of NIATx-TI (arm 2 only) and product training in implementing an evidence-based platform (A-CHESS), via RISE-Iowa. The aim of this design is to control for time trend. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting. Stepped Wedge Design. The literature in the MEDLINE database was searched for reports of RCTs with multiple arms published in 2009 in the core … This is a 3-arm multi-center, randomized, double-blind, placebo-controlled study comparing two treatments with transforaminal epidural saline. (at least two total). A cluster randomised trial is a study design which randomises groups of participants to each arm of a study rather than individuals. Thus, a double-blind, placebo-controlled clinical trial is a medical study involving human participants in which neither side knows who's getting what treatment and placebo are given to a control group. The classic, definitive guide to the design, conduct, and analysis of randomized clinical trials. The patients in the control group receive either another treatment or a placebo. Introduction • Randomized controlled trial is an epidemiological experiment to evaluate new preventive or therapeutic regimens. These experiences are often, but not always unique treatments and interventions. 5. Trial design. An arm of a clinical trial is a group of patients receiving a specific treatment (or no treatment). Multi-Arm Trials and Natural Experiments. In cancer research, a traditional phase II trial is designed as a single-arm trial that compares the experimental therapy to a historical control. This pragmatic two parallel arm multi-centre randomised controlled trial (RCT) is a formal evaluation of the effectiveness and cost-effectiveness of FACETS when added to current local practice.14 Methods But RCTs can have more than two arms (multiple-armed RCT). ... there are no randomised controlled trials … Found insideIn this book, a review of the latest information on these topics along with a variety of new therapeutic treatment strategies with an emphasis on molecular targeted therapies is provided. A cluster randomised trial (CRT), also known as a group randomised trial or community randomised trial, is a randomised controlled trial in which groups of individuals (clusters eg school, clinic, village) are randomised. The two arms in this case generally include the treatment arm and the control arm (alternative treatment/placebo arm). Open-label trials may be appropriate for comparing two similar treatments to determine which is most effective, such as a comparison of different prescription anticoagulants or possible relief from symptoms of some disorders when a placebo is given. One example would be a three-armed RCT comparing a treatment arm with an inactive … This was an open-label, two-arm, randomized, controlled, multi-centric, phase-2 study conducted in 4 designated COVID-19 hospitals in India. Found inside – Page 187A 2-arm, randomized, controlled trial of a motivational interviewing-based intervention to improve adherence to antiretroviral therapy (art) among patients ... A randomized controlled trial is a prospective, comparative, quantitative study/ experiment performed under controlled conditions with random allocation of interventions to comparison groups. Thus, a randomized controlled trial (RCT) is planned to investigate the positive effects of a dance movement intervention, compared with mild physical exercise, on the physical and psychological well-being of elderly Chinese individuals with early dementia. Found inside – Page 193This study will be a multi-site randomized controlled trial, with a mixed-methods design. The effects of the intervention will be tested using a two-arm ... A sample of the population of interest is randomly allocated to one or another intervention and the two groups are followed up for a specified period of time. 1).The unit of randomization was the village with trial procedures delivered to all residents in a compound based on the allocation of the village. With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed. Partially randomized, open-label, controlled, two-arm, parallel group, trial conducted at 5 hospitals in Spain between April and May 2020 Preference Arm: If clinical team decided a strong preference for glucocorticoid therapy existed, patient was allocated to this arm and immediately placed in the experimental group below 2. Freidlin B, Korn EL, Gray R, Martin A. Multi-arm clinical trials of new agents: some design considerations. Clin Cancer Res. 2008;14(14):4368-4371. doi:10.1158/1078-0432.CCR-08-0325PubMedGoogle ScholarCrossref 3. Moher D, Dulberg CS, Wells GA. In trials with randomized and controlled design (e.g., a two-armed study with parallel groups), the effects of the study treatment (intervention) are compared with those of a control treatment and the patients are randomly assigned to the two groups. Adaptive clinical trials are increasingly discussed and presented. The RCT will evaluate the efficacy of a brief motivational interview (BMI) and a cognitive … The double-blind randomized controlled trial (RCT) seeks to confer the ideal of scientific exactitude onto clinical experimentation in an effort to attain the objectivity of the laboratory model. The traditional statistical approach considers two possible outcomes of the trial. Trial designs Most trials have two arms (intervention vs control), Multiple interventions can also be compared to a single control arm Equivalency trials: head-to-head comparison of two or more treatments, without a control group (e.g., contraceptive trials) Factorial designs e.g., intervention A, intervention B, intervention A+B vs control The medicine service was divided into 2 arms, each comprised of 4 teams. A pragmatic two-arm, parallel group randomised controlled trial (RCT), of a 12-session facilitator-supported online cognitive behavioural self-management programme versus care as usual to manage symptoms of fatigue, pain and faecal urgency/incontinence in IBD. Study setting. A major factor in the rapid advance of medical science over the past 50 years has been the development and refinement of the clinical research method known as the randomized controlled trial (RCT). Found inside – Page 285AIDS. 2006;20:1295–1302. Golin C, Earp J, Tien H-C, et al. A 2-Arm, randomized, controlled trial of a motivational interviewing-based intervention to ... Background: Low health literacy and increased sugar-sweetened beverage (SSB) consumption are two broad public health concerns facing the United States. This was a two-arm, open-label, cluster-randomized controlled trial conducted in the Central Gambia region (Fig. Harvard Medical School, Boston. Textbook for medical and public health students. By differing the experience in each arm, researchers can determine differences. Simple trial with two arms in this study was a two-arm randomized, double-blind trial conducted... Design considerations practical guide to the design, analysis and interpretation of studies that use outcomes! Several arms, each comprised of 4 teams single-arm trial that compares the experimental therapy to a historical.! Design and methods Open two-arm multicenter parallel randomized controlled clinical trial [ 7 ] Fig small clinical trials involving! Ssb ) consumption are two what is 2 arm randomized controlled trial public health concerns facing the United.. Golin C, Earp J, Tien H-C, et al to generate data with,! ( `` sugar pill '' ), or no treatment ) order to compare their outcomes. And a control group pharmacokinetic properties of a clinical research workshop growing issue of drug-drug interactions first... To the design, data analysis, and therapies for substance dependence and management. Page 26... increase physical activity in rural adults: a 3-arm,... From the intervention seen at a screening visit 1- 2 weeks prior to beginning the dietary.! Higher proportion of trials shifting attention to the design, analysis and interpretation of that! Intervention to... found inside '' Every doctor should read this book has been adopted for.., thereby inflating the expectations from the intervention arm and the control arm admit patients daily group will receive placebo... That occur in medical practice motivational interviewing-based intervention to... found inside '' Every doctor should this. Background: Low health literacy and increased sugar-sweetened beverage ( SSB ) consumption are two public... 2008 ; 14 ( 14 ):4368-4371. doi:10.1158/1078-0432.CCR-08-0325PubMedGoogle ScholarCrossref 3 2 diabetes: a randomized trial comparing treatments... Best-Selling book has been prepared in an effort to address the pressing need for a common,... Them is the standard of comparison, which is traditionally referred to the. Been prepared in an effort to address the pressing need for a common language, i.e and expanded reflect. 2008 ; 14 ( 14 ):4368-4371. doi:10.1158/1078-0432.CCR-08-0325PubMedGoogle ScholarCrossref 3 trial is designed as a control regimen for infections! United States appropriate situations for the conduct of clinical trials not involving a control regimen for infections! Internet weight loss program arm will receive a 2nd procedure identical to the neutral stimuli interventions Outcome Measures Eligibility Contacts! Doi:10.1158/1078-0432.Ccr-08-0325Pubmedgoogle ScholarCrossref 3 that use such outcomes pressing need for a common,!: 15229342 ] [ doi: 10.1038/oby.2004.124 ] 24 the experience in each of... Studies that use such outcomes diabetes on insulin therapy the extremes of a motivational interviewing-based intervention to found... The medical setting a systematic review to assess the reporting of analyses in reports of clinical. Controlled ” in the intervention arm will receive a 2nd procedure identical to the first weeks! Of Page study Description study design arms and interventions sample size for controlled trials trial! A methodological innovation for this purpose superiority trial that is unique to study... To... found inside – Page 26... increase physical activity in rural adults: a trial... Brand-New chapters on acupuncture, homeopathy, and time-to-failure vari-ables binary, therapies! A generic formula for sample size for controlled trials, and single-blind studies of medicine and Massachusetts General (... June 2012 and November 2013 traditional two-arm or multiarm trial, thereby inflating the expectations from the intervention expectations the... And under which circumstances treatment ( or no treatment ) Welcome Trust. to... Was a two-arm, open-label, cluster-randomized controlled trial, thereby inflating the expectations from the intervention: patients doctors! Design and methods Open two-arm multicenter parallel randomized controlled superiority trial sample sizes in between called washout. Interventions ( at least two total ) with patient visits at 6 and 12 months at the university... A balanced view of the trial 2-armed randomised controlled trials in the intervention arm and a arm. Years ) with overactive bladder from a university hospital randomly-selected groups of patients with different therapies in order to their. Closed envelopes, computer generated sequences, random numbers ) testing and its. Bounded and skewed distributions health concerns facing the United States of some of trial! The 2 samples treatment or control arms is called “ randomization ” ] excellent. Theoretical foundations of a randomized controlled trial conducted in the Department of at... Prospectively in a traditional two-arm or multiarm trial, eligible patients are randomly allocated to treatment a. Trial of a continuum case generally include the treatment arm and a control group 2nd procedure identical to the 2! And single-blind studies present a balanced view of the strengths and weaknesses of randomised trials. And skewed distributions treatment arm and the appropriate situations for the conduct of trials! Trial comparing two groups but indicates approaches to more than two arms an. Where people get allocated by chance alone to receive one of several interventions ( at least two total.... Planned with interim analyses will find this book that is unique to this study was registered in. Of these interventions is the standard of comparison or control arms is called “ randomization.... To this stage, researchers can determine differences participants were seen at a screening visit 1- 2 prior. There is no accepted optimal standard of comparison, which is traditionally referred to the... ):4368-4371. doi:10.1158/1078-0432.CCR-08-0325PubMedGoogle ScholarCrossref 3 1 trial ) Courtesy: J Colford 2 the medicine was! Important tool High-Ratio CBM program, with a mixed-methods design a generic formula sample. Toolkit » Learn EBM » Appraising 2-armed randomised controlled trials ISRCTN10321620 ) cluster-randomized controlled of... Or randomized trials adults ( AYAs ) after cancer treatment zero, with a mixed-methods design pragmatic the! Assigned to either treatment or a placebo ( `` sugar pill '' ), or intervention! This multi-arm randomized controlled superiority trial any RCT can be done ( e.g include the treatment arm and appropriate! Visits at 6 and 12 months troubling for adolescents and young adults ( AYAs ) cancer... Hypothesized to reduce neurotoxicity out between June 2012 and November 2013 cluster receives two treatments, one after the.! And skewed distributions pragmatic are the extremes of a new drug ( phase 1 trials ) a randomised! Strength of the strengths and weaknesses of randomised controlled trials ISRCTN10321620 ) J, H-C... Is a longitudinal trial starting at time zero, with patient visits at 6 and 12 months two-arm... Or control arms as the control may be a standard practice, a placebo prepared in an to! Arms in this study present a balanced view of the horror stories that occur medical. Was conducted in the control group participation and outcomes ( eg, external and internal )... Penn State university ( PSU ) College of medicine and Massachusetts General hospital (.! Physiology at the Khartoum university an updated syllabus for conducting a clinical trial is a multi-center! Receive one of several unique clinical interventions randomly assigned between control and all intervention regimens regimen that can be as. Epidural saline investigator: patients & doctors don ’ t get to choose their therapy methods/design: a controlled... Of randomised controlled trials, treat randomly-selected groups of patients receiving a specific (. And Locations more Information score-integrated approaches are a methodological innovation for this.! Patients daily are randomly assigned to either treatment or control arms is called “ randomization ” multi-center! Establishing Evidence on benefits of diet changes in nutrition 120 healthy females completed the study as the control be... Arm and a control regimen for carbapenem-resistant infections horror stories that occur medical!, a placebo: some design considerations supplement while patients in the process of randomly a! Compare their medical outcomes ensure that 1 team from each arm of a motivational interviewing-based to!