InterventIon research

Bernadette Mazurek Melnyk, PhD, rn, cPnP/PMhnP, FnaP, Faan. Bernadette Mazurek Melnyk is currently associate vice president for health promotion, University Chief Wellness officer, and dean of the College of Nursing at The Ohio State University where she also is a pro-fessor in the College of Medicine. Formerly, she was dean and distinguished foundation profes-sor at Arizona State University College of Nursing and Health Innovation. Dr. Melnyk earned her Bachelor of Science in Nursing (BSN) degree from West Virginia University, her Master of Science in Nursing (MSN) degree with a specialization in nursing care of children and pediat-ric nurse practitioner from the University of Pittsburgh, and her PhD in clinical research from the University of Rochester where she also completed her postmaster’s certificate as a psychi-atric mental health nurse practitioner. She is a nationally/internationally recognized expert in evidence-based practice, intervention research, and child and adolescent mental health, and is a frequent keynote speaker at national and international conferences on these topics. Dr. Melnyk has served as a scientific reviewer for multiple study sections and special emphasis panels at the National Institutes of Health (NIH) and has consulted with health care systems and colleges throughout the nation and globe on how to implement and sustain evidence-based practice. Her record includes more than $11 million of sponsored funding from federal agencies as principal investigator and more than 180 publications.

Dr. Melnyk is coeditor of the well-known book, Evidence-based Practice in Nursing & Health-care: A Guide to Best Practice, Implementing Evidence-based Practice: Real Life Success Stories, and the KySS Guide for Child and Adolescent Mental Health Screening, Early Intervention and Health Promotion. She is an elected fellow of the American Academy of Nursing and the National Academies of Practice and recently completed a 4-year term on the U.S. Preventive Services Task Force. She also serves as associate editor of the journal, Worldviews on Evidence-based Nursing. In 2001, Dr. Melnyk founded the National Association of Pediatric Nurse Practitioners’ KySS program, a na-tional initiative to promote the mental health of children and teens, which she directed for nearly a decade. Dr. Melnyk has received numerous national and international awards, including the Audrey Hepburn Award from Sigma Theta Tau International; the Jessie Scott Award from the American Nurses Association for the improvement of health care quality through the integra-tion of research, education, and practice; and the NIH/National Institute of Nursing Research’s (NINR) inaugural director’s lectureship award. She was recently inducted into Sigma Theta Tau’s International Researcher Hall of Fame and also recognized as an Edge Runner by the American Academy of Nursing for the KySS program and her COPE program for parents of preterm infants.

Dianne Morrison-Beedy, PhD, rn, WhnP-Bc, FnaP, FaanP, Faan. Dr. Morrison-Beedy currently serves as the dean of the University of South Florida (USF) College of Nursing and senior associate vice president of USF Health. She also is a professor in the Colleges of Nursing and Public Health. Prior to this appointment, she was the professor and endowed chair of Nurs-ing Science and assistant dean for research at the University of Rochester, School of Nursing. Dr. Morrison-Beedy has focused her research on HIV/AIDS risk reduction, especially for vul-nerable adolescent girls. Since 1993 as principal and coinvestigator, she has received more than $11 million in HIV prevention research funding and most recently conducted a NINR funded study on HIV prevention trial in urban adolescent girls. Dr. Morrison-Beedy’s interdisciplin-ary contributions also encompass serving as scientific reviewer for multiple HIV-related study sections and special emphasis panels at the NIH. In recognition of her contributions, she most recently received the Florida Nursing Association Award for Research (2011) and the Association of Women’s Health, Obstetric and Neonatal Nurses Award for Excellence in Research (2010), the Association of Nurses in AIDS Care (ANAC) Research Recognition Award (2009), Excellence in HIV Prevention Award (2005), and the New York State Distinguished Nurse Researcher Award (2004). She is an elected fellow in the American Academy of Nursing, the American Academy of Nurse Practitioners, and the National Academies of Practice. Dr. Morrison-Beedy served as faculty for Sigma Theta Tau International Chiron Nursing Leadership Program and Johnson & Johnson Maternal and Child Health Leadership Institute. She is a reviewer for numerous scientific journals and has more than 200 published articles and abstracts. Dr. Morrison-Beedy received her BSN from Niagara University, her MSN with a specialization in maternal and wom-en’s health nurse practitioner from the State University of New York at Buffalo, and completed her PhD at the University of Rochester.

InterventIon research

DesIgnIng, conDuctIng, analyzIng, anD FunDIng

Bernadette Mazurek Melnyk, PhD, RN, CPNP/PMHNP, FNAP, FAANDianne Morrison-Beedy, PhD, RN, WHNP-BC, FNAP, FAANP, FAAN

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Intervention research : designing, conducting, analyzing, and funding / Bernadette Mazurek Melnyk, Dianne Morrison-Beedy, editors. p. ; cm. Includes bibliographical references and index. ISBN 978-0-8261-0957-6 — ISBN 978-0-8261-0958-3 (e-book) I. Melnyk, Bernadette Mazurek. II. Morrison-Beedy, Dianne. [DNLM: 1. Intervention Studies. 2. Research Design. 3. Biomedical Research—methods. 4. Ethics, Research. 5. Financing, Organized. 6. Research Report. WA 20.5] 610.72’4—dc23 2012010620

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It is with heartfelt thanks and appreciation that I dedicate this book to my wonderful family: John, my loving and supportive husband; and Kaylin, Angela, and Megan, my three daughters who are beautiful inside and out. I know that it has not been easy to have a wife and mom who is so passionate about her dreams of making a difference.

I cannot tell you enough how very much I have appreciated your love, understanding, and support. Remember, never let anyone take your dreams away, and persist through the “character builders” until they come to fruition. I also want to dedicate this book to my dad, Joseph A. Mazurek, who possessed a never-ending spirit of joy, enthusiasm,

determination, and support, which has so positively impacted my life’s journey.

Bernadette Mazurek Melnyk

I dedicate this book to those most dear to me. To my dear husband Michael, your love and support are the basic ingredients for my success in making ideas a reality. To my daughter Megan and son Mason—Remember, hold on tight to your dreams. To make

your dreams a reality requires hard work, perseverance, and a stick-to-it determination. I have the utmost faith you will both achieve great things—all things are possible for those who believe. My ultimate thanks go to my Mom, Jean Morrison, and late

dad, William R. Morrison—they taught me in both words and deeds what it takes to persevere and to enjoy the wonderful journey that life has to offer.

Dianne Morrison-Beedy

vii

contents

Contributors xiForeword Virginia A. Moyer xvPreface xviiAcknowledgments xix

PArt i: dEsiGNiNG iNtErVENtioN stUdiEs

1. Setting the Stage for Intervention Research: The “So What” Factor 1 Bernadette Mazurek Melnyk and Dianne Morrison-Beedy

2. Using Theory to Guide Intervention Research 11 Julie Fleury and Souraya Sidani

3. Nuts and Bolts of Designing Intervention Studies 37 Bernadette Mazurek Melnyk, Dianne Morrison-Beedy, and Shirley M. Moore

4. Designing Interventions That Are Sensitive to Culture, Race/Ethnicity, and Gender 65

Usha Menon

5. Ethical Considerations in Designing Intervention Studies 75 Dónal P. O’Mathúna

6. Minimizing Threats to Internal Validity 91 Jacqueline Dunbar-Jacob

7. Minimizing Threats to External Validity 107Wanda K. Nicholson

8. Measurement in Intervention Research 121 Dianne Morrison-Beedy and Bernadette Mazurek Melnyk

9. Biological Measurement in Intervention Research 135 Donna McCarthy

PArt i: dEsiGNiNG iNtErVENtioN stUdiEs

viii Contents

PArt ii: iMPLEMENtiNG iNtErVENtioN stUdiEs

10. Developing the Budget for Intervention Studies 149 Barbara Smith and Steven Pease

11. Navigating the IRB for Investigators 169 Amanda A. Hastings, Cheryl L. Byers, and Barry B. Bercu

12. Participant Recruitment and Retention 193 Constance Visovsky and Dianne Morrison-Beedy

13. Maintaining Fidelity of the Intervention 213 Ashleigh Collins, Nicole Colwell, and Sandee McClowry

14. Study Implementation: An Example Using the Madres Para la Salud (Mothers for Health) Study 229

Colleen Keller and Barbara Ainsworth

15. Considerations in Conducting Interventions in Specialized Settings 243

15.1. Conducting Interventions in Community Settings 244 Usha Menon

15.2. Conducting Interventions in Public Health Settings 247 LaRon E. Nelson and Dianne Morrison-Beedy

15.3. Conducting Interventions in School Settings 255 Bonnie Gance-Cleveland

15.4. Conducting Interventions in Acute Care Settings 260 Cindy Munro

15.5. Conducting Interventions in Long-Term Care Settings 265 Debra Parker Oliver, David B. Oliver, and Geraldine Dickey

15.6. Conducting Interventions in Palliative Care Settings 271 Kathryn B. Lindstrom

15.7. Conducting Interventions in Global Settings 277 Carol M. Baldwin and Christine Hancock

15.8. Conducting Interventions in Multisite Settings 282 Peter A. Vanable

16. Data Management 295 Kevin E. Kip and Sharon M. Lawlor

PArt iii: ANALYZiNG iNtErVENtioN stUdiEs

17. Analyzing Intervention Studies 315 Laura A. Szalacha

18. Cost-Effectiveness Analyses for Intervention Studies 331 Kimberly Sidora-Arcoleo and Kevin Frick

19. Explaining Intervention Effects 343 Kimberly Sidora-Arcoleo and Darya Bonds McClain

PArt ii: iMPLEMENtiNG iNtErVENtioN stUdiEs

PArt iii: ANALYZiNG iNtErVENtioN stUdiEs

Contents ix

PArt iV: WritiNG sUCCEssFUL GrANts ANd ProGrEss rEPorts

20. Writing Grants That Fund! 361Bernadette Mazurek Melnyk and Dianne Morrison-Beedy

21. Submitting a Research Grant Application to the National Institutes of Health: Navigating the Application and Peer Review System 385

Mindy B. Tinkle

22. Writing Progress and Final Reports 399 Shirley M. Moore and Margaret Roudebush

PArt V: dissEMiNAtiNG ANd trANsLAtiNG iNtErVENtioN rEsEArCH FiNdiNGs iNto rEAL-WorLd sEttiNGs

23. Disseminating Findings of Intervention Studies 421 Marion E. Broome

24. Translating Evidence-Based Interventions Into Real-World Practice Settings 443

Bernadette Mazurek Melnyk

Glossary 453Index 465

PArt iV: WritiNG sUCCEssFUL GrANts ANd ProGrEss rEPorts

PArt V: dissEMiNAtiNG ANd trANsLAtiNG iNtErVENtioN rEsEArCH FiNdiNGs iNto rEAL-WorLd sEttiNGs

xi

contrIButors

Barbara ainsworth, PhD, MPh, FacsM, FnaK Professor, School of Nutrition and Health Promotion, Arizona State University, Phoenix, Arizona

carol M. Baldwin, PhD, rn, chtP, ct, ahn-Bc, Faan Associate Professor, Southwest Borderlands Scholar, Director, Center of World Health Promotion & Disease Prevention, College of Nursing and Health Innovation, Arizona State University, Phoenix, Arizona

Barry B. Bercu, MD, FaaP Professor of Pediatrics, Molecular Medicine, and Molecular Pharmacology and Physiology, College of Medicine, University of South Florida, Tampa, Florida

Marion e. Broome, PhD, rn, Faan Distinguished Professor, Department of Family Health, Dean, School of Nursing, Indiana University, Indianapolis, Indiana

cheryl l. Byers, Mha, cIP Director of Research Integrity and Compliance, Office of Research and Innovation, University of South Florida, Tampa, Florida

ashleigh collins, Med Doctoral Student, Early Childhood Education, New York University, New York, New York

nicole colwell, Ma Educational Psychology-MESA Doctoral Program, University of Illinois at Chicago, Chicago, Illinois

geraldine Dickey, PhD, lcsW Assistant Professor, Director, School of Social Work, Missouri Western State University, Springfield, Missouri

Jacqueline Dunbar-Jacob, PhD, rn, Faan Dean, School of Nursing, Professor of Nursing, Epidemiology, Psychology, and Occupational Therapy, University of Pittsburgh, Pittsburgh, Pennsylvania

Julie Fleury, PhD, Faan Director, PhD in Nursing and Health Care Innovation Program, College of Nursing and Health Innovation, Arizona State University, Phoenix, Arizona

Kevin Frick, PhD, Ma Professor, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland

Bonnie gance-cleveland, PhD, rnc, PnP, Faan Associate Professor, Director, Center for Improving Health Outcomes in Children, Teens & Families, College of Nursing and Health Innovation, Arizona State University, Phoenix, Arizona

xii Contributors

christine hancock, Bsc (econ), rn Founder and Director, C3 Collaborating for Health, London, United Kingdom

amanda a. hastings, Mshl Education Specialist, Division of Research Integrity and Compliance (DRIC), University of South Florida, Tampa, Florida

Colleen Keller, PhD, rn-c, aPrn, Faha, FnaP Director, Center for Health Outcomes in Aging, Director, Hartford Center of Geriatric Nursing Excellence, College of Nursing and Health Innovation, Arizona State University, Phoenix, Arizona

Kevin e. Kip, PhD, Faha Associate Professor, Executive Director, Research Center, College of Nursing, University of South Florida, Tampa, Florida

sharon M. lawlor, MBa Research Associate of Epidemiology, Graduate School of Public Health, Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania

Kathryn B. lindstrom, PhD, FnP-Bc, achPn Palliative Care Program Coordinator, Assistant Professor, School of Nursing, Vanderbilt University, Nashville, Tennessee

Donna Mccarthy, PhD, rn, Faan Associate Dean for Research and Mildred E. NewtonProfessor of Nursing, College of Nursing, The Ohio State University, Columbus, Ohio

Darya Bonds Mcclain, PhD Associate Research Professor, College of Nursing and Health Innovation, Arizona State University, Phoenix, Arizona

sandee Mcclowry, PhD, rn, raan Professor of Applied Psychology, Steinhardt School of Culture, Education, and Human Development, New York University, New York, New York

Bernadette Mazurek Melnyk, PhD, rn, cPnP/PMhnP, FnaP, Faan Associate Vice President for Health Promotion, University Chief Wellness Officer, Dean and Professor, College of Nursing, Professor of Pediatrics & Psychiatry, College of Medicine, The Ohio State University, Columbus, Ohio

usha Menon, PhD, rn, Faan Vice Dean and Professor, College of Nursing, The Ohio State University, Columbus, Ohio

shirley M. Moore, rn, PhD, Faan The Edward J. and Louise Mellen Professor of Nursing; Associate Dean for Research, Frances Payne Bolton School of Nursing, Cleveland, Ohio

Dianne Morrison-Beedy, PhD, rn, WhnP-Bc, FnaP, FaanP, Faan Senior Associate Vice President, USF Health, Dean, College of Nursing, University of South Florida, Tampa, Florida

cindy Munro, PhD, rn, anP, Faan Professor, Associate Dean of Research and InnovationCollege of Nursing, University of South Florida, Tampa, Florida

laron e. nelson, PhD, Ms, Bs Assistant Professor, Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada

Wanda K. nicholson, MD, MPh, MBa Associate Professor of Obstetrics and Gynecology, School of Medicine, Director, Diabetes and Obesity Core, Center for Women’s Health Research, School of Medicine, University of North Carolina, Chapel Hill, North Carolina

Dónal P. o’Mathúna, Bsc, (Pharm), Ma, PhD Lecturer, Science and Health, Dublin City University, Dublin, Ireland

Contributors xiii

David B. oliver, PhD Research Professor, Assistant Director of University of Missouri Interdisciplinary Center on Aging, School of Medicine, University of Missouri, Columbia, Missouri

Debra Parker oliver, PhD, MsW Associate Professor, School of Medicine, University of Missouri, Columbia, Missouri

steven Pease, Mas, Bs Director, Division of Sponsored Programs, RES, School of Nursing, University of Maryland, Baltimore, Maryland

Margaret roudebush, Mno, FPB Director, Center for Research and Scholarship, General Operating, School of Nursing, Case Western Reserve University, Cleveland, Ohio

souraya sidani, PhD Professor, Daphne Cockwell School of Nursing, Ryerson University, Toronto, Ontario, Canada

Kimberly sidora-arcoleo, PhD, MPh Associate Professor and Director, Center for Promoting Health in Infants, Children, Adolescents & Women, College of Nursing, The Ohio State University, Columbus, Ohio

Barbara smith, PhD, rn, FascM, Faan Professor, FCH, Associate Dean for Research, School of Nursing, University of Maryland, Baltimore, Maryland

laura a. szalacha, edD Research Associate Professor and Associate Director, Office of Research & Scholarship, College of Nursing, The Ohio State University, Columbus, Ohio

Mindy B. tinkle, PhD, rn, WhnP-Bc Associate Professor, Research Team Leader, College of Nursing, University of New Mexico, Albuquerque, New Mexico

Peter a. vanable, PhD Associate Professor and Chair, Department of Psychology, Syracuse University, Syracuse, New York

constance visovsky, PhD, rn, acnP-Bc Associate Dean of Student Affairs and Community Engagement, College of Nursing, University of South Florida, Tampa, Florida

xv

ForeWorD

A long-held bit of conventional wisdom says that only 20% of what we do in health care is supported by strong scientific evidence—and although no one could possibly really measure this across all of health care, we do know a little something about common medical interventions. Nearly 3,000 common treatments are included in Clinical Evidence, a British publication in which the evidence for common interventions is assessed. For more than 50% of the treatments included, there is too little evidence available to even make an assessment of their effectiveness. If we expanded this beyond common medical treatments to include common diagnostic tests, aspects of nursing care, and public health interventions, I have no doubt that the evidence base would be even thinner. This is, of course, the bad news and the good news. It’s bad news for the patients who are subjected daily to treatments with unknown effectiveness, but it’s good news for investigators—there is no shortage of need for high-quality intervention research.

Melnyk and Morrison-Beedy and their colleagues, in this concise but complete volume, offer researchers practical guidance that will help them move health care forward with good quality evidence to support both practice and policy. They make the case loud and clear that high-quality intervention research is needed and outline how to get that done. The book is organized in the order in which research activities occur—starting with how to use theory to start a project and moving through study design, settings, data management and analysis, the nitty-gritty of dealing with the Institutional Review Board (IRB) and fund-ing agencies, and finally translating the findings into the real world. Each chapter contains clear and useful examples and concludes with the key points of the chapter. Although the chapters stand alone, researchers may well find that they will want to skim the whole book and then use each chapter as a guide during the relevant phase of a research project. Pearls of wisdom from seasoned, funded investigators throughout the book will provide the tools that researchers need to design, conduct, and fund high-quality intervention studies.

We do clinical research for many reasons—curiosity, recognition, publication, promotion and tenure, to better understand disease, to make a contribution—but most importantly, to benefit our patients. The benefits will be greatest when the research is conducted well. This book is intended to help researchers do exactly that—conduct interventional studies in health care in the best possible manner. It is time to make a dent in that 50% of common treatments for which there is currently no good evidence from interventional studies.

Virginia A. Moyer, MD, MPHChair, United States Preventive

Services Task ForceProfessor of PediatricsBaylor College of Medicine

xvii

PreFace

We have long had a passion for making a positive difference in the lives of vulnerable people, and an endless curiosity about what types of interventions would have the greatest and most useful impact on health outcomes. Intervention research for both of us was deeply rooted in clinical practice; a fertile ground for being able to identify gaps in interventions that could address the unmet needs of individuals, families, and com-munities. As longtime colleagues, we had the opportunity to have multiple discussions about how best to conduct meaningful and rigorous research that would target these unmet needs. After our doctoral program, both of us pursued our dreams of making a difference through rigorous programs of intervention research. We went through the typical “character builders” of every step involved in intervention work, beginning with pilot studies that eventually became funded by the National Institutes of Health (NIH) as full-scale randomized controlled trials. Throughout the years, we have said to each other that all of the “lessons that we learned” and “tricks of the trade” should be com-piled into one “user-friendly” reference where others could learn from those who have successfully traveled down the intervention pathway. In talking with other investiga-tors throughout the country, it was obvious that there was a tremendous need for this type of content. Therefore, we launched a 3-day intensive workshop on intervention studies that drew individuals from across the country who were hungry for knowledge and skills in how to design, conduct, analyze, and fund intervention studies. From this workshop came the idea for our book and, one day, we made a pact to publish this down-to-earth, common sense guide that can assist others in successfully making a difference through intervention research. It is our dream that this book will accelerate the conduct of rigorous intervention studies that will ultimately produce the evidence needed to guide practice in real-world settings and positively influence health policy. To assist researchers even further, we have provided examples of successfully funded grants. These funded applications can be accessed at www.springerpub.com/melnyk. As an investigator, wherever your passion and curiosity lie, we hope that this book will assist you in realizing your dream of making a difference through intervention work.

With warm regards,

Bernadette “Bern” Mazurek Melnyk and Dianne Morrison-Beedy

xix

acKnoWleDgMents

It typically takes a team to accomplish a major initiative, such as the production of a book, and we were truly blessed with an awesome team who worked tirelessly on this project. I want to thank and recognize my wonderful friend, colleague, and coeditor, Dr. Dianne Morrison-Beedy, who embarked on this journey with me and weathered the “character builders” along the course of the way. I also want to thank and acknowledge each of our terrific contributors, for without them, this book would not be possible. In addition, I thank and recognize my supportive husband, John, and my three wonderful daughters, Kaylin, Angela, and Megan, who have sacrificed time with me over the years so that I could pursue my dreams. Finally, I thank Kathy York, who has been the “wind beneath my wings” during the writing of this book, and my colleagues, study teams, doctoral students and research subjects, from whom I have learned, and the support staff at the University of South Florida who supported this initiative.

Bernadette Mazurek Melnyk

My thanks go out to all the chapter authors and my team at the University of South Florida College of Nursing who dealt with the logistics of two cross-country editors, particularly Melanie Martinez, Morrow Omli, Judy Plazarin, and Dr. Melissa M. Shelton. Certainly, my family’s support has been unwavering throughout all my endeavors. My husband, Michael, deserves so much credit for keeping our hectic home life on track while always maintaining a sense of humor and optimism. For all the members of HIP Teens research team, especially the late Dr. Sheryl Jones; my coinvestigator and mentor, Dr. Michael P. Carey; and all the doctoral students and study participants who helped me learn the nuances of what it takes to be a research scientist—I am eternally grateful.

Dianne Morrison-Beedy

How wonderful that no one needs to wait a single moment to improve the world.—Anne Frank

1

settIng the stage For InterventIon research:

the “so What” Factor

Bernadette Mazurek Melnyk & Dianne Morrison-Beedy

Intervention research is all about learning what treatments or strategies work best to improve outcomes and making a difference in what matters most to you. Although developing and testing interventions can be a challenging and lengthy process, es-tablishing the effi cacy of a new intervention or treatment that improves the health of a population for whom you care deeply about is both personally and professionally rewarding. Although there are numerous areas in health, social sciences, and educa-tion that could benefi t from intervention research, the majority of studies conducted are nonexperimental in design. As a result, we frequently lack the strongest level of evidence needed to change practice, infl uence policy, and positively impact outcomes in these fi elds.

Intervention studies, also known as experimental research , are the only type of re-search that allows us to draw conclusions about cause and effect relationships between an intervention or treatment and an outcome . A true experiment or randomized controlled trial (RCT) is the strongest type of intervention study for testing cause and effect relationships . There are three components required in a true experiment: an intervention or treatment, a comparison or control group, and random assignment of participants to experimental or comparison/control groups.

First, there is an experimental intervention in which the investigator actually “does something” to some but not all of the participants in the study (the intervention group). Second, a comparison intervention or control group is needed to compare the effects of the experimental intervention on outcomes between those who received it and those who did not. Third, random assignment (randomly assigning subjects to the

Part i: designing intervention studies

2 i. designing intervention studies

experimental or attention groups by probability, such as fl ipping a coin) is used to place participants in either the experimental group or the comparison/control group.

Examples of research questions that would be best answered by intervention studies include the following:

In adolescents with anxiety (the designated population), what is the effect of cognitive behavioral skills building (the experimental intervention) versus an education-only intervention (the comparison condition) on substance use (the outcome)?

In patients with hypertension (the designated population), what is the effect of providing on-site counseling by a pharmacist (the experimental intervention) versus written information in a pamphlet (the comparison intervention) on medication adherence (the outcome)?

In critically ill patients (the designated population), what is the effect of early ambu-lation (the experimental intervention) versus continuous bed rest (comparison condition) on episodes of ventilator-associated pneumonia (the outcome)?

In elementary school children (the designated population), what is the effect of an after-school mentoring program (the experimental intervention) versus indi-vidual tutoring (the comparison intervention) on academic performance (the outcome)?

tHE tYPiCAL ProGrEssioN oF rEsEArCH

nonexperimental designs (e.g., qualitative , descriptive , and predictive research ) are best suited when constructs need to be described (e.g., the grief process for par-ents whose child has died) or there is a desire to determine relationships among variables (e.g., whether there is a relationship between exercise and hypertension in older adult men or whether depression predicts substance use in adolescents). Ex-perimental designs are used when an investigator would like to establish causality (i.e., whether certain treatments or intervention strategies cause changes in selected outcomes).

The following diagram represents the typical progression of research.

Qualitative Research → Descriptive Research → Predictive Research → Experimental Research

In order to establish causality, there are three criteria that are necessary, including (a) the independent variable (i.e., the treatment) must precede the dependent variable(i.e., the outcome), (b) there must be a strong relationship between the intervention and the outcome, and (c) the relationship between the treatment and outcome cannot be ex-plained as being due to the infl uence of other variables. For example, an investigator is testing the effects of a 6-week cognitive behavior therapy program versus a 6-week yoga program in reducing fear of fl ying in adults. The week before the subjects are scheduled to complete the follow-up questionnaire to measure their fear of fl ying, the study par-ticipants learn about a major airline crash that kills 179 people. If the fi nal results of the study reveal no differences between the two intervention groups on their fear of fl ying, the investigator could not conclude that cognitive behavior therapy or yoga are ineffec-tive in reducing fear of fl ying because a major confounding variable occurred—that of the airline crash.

Programs of research are frequently halted at the descriptive or predictive stage, and investigators never move to developing and testing interventions that could posi-

tHE tYPiCAL ProGrEssioN oF rEsEArCH

1. setting the stage for intervention research: the “so What” Factor 3

tively impact outcomes in individuals, families, and communities. This scenario is common because researchers are often limited in the knowledge and skills needed to design, conduct, analyze, and fund intervention studies. This book provides useful information to prepare you for an exciting journey as an interventionist with a focus on “real world” advice and wisdom from investigators who have successfully traveled down that road.

tHE “so WHAt” FACtor iN iNtErVENtioN rEsEArCH

One of the fundamental building blocks that lays the foundation for intervention work is the “so what” factor.

The “so what” factor is a term we are using to describe the development and con-duct of research with high-impact potential to improve outcomes. The questions that will follow are ones that every investigator needs to refl ect upon as they begin to design a new intervention study.

l “So what” is the prevalence of the problem and is it modifi able through an intervention?

l “So what” will be the end outcome of the study once it is completed? l “So what” difference will the study make in improving health, education or health

care quality, costs, and, most importantly, patient, family, or community outcomes? l “So what” will others do with the study’s outcomes (e.g., clinicians, health care

systems, schools, public health departments)? l “So what” actions will you take to translate your study’s fi ndings to real world

settings? l “So what” is the chance that others will adopt and implement your intervention

based on its feasibility, reproducibility, and cost?

We must focus more on the “so what” factor as investigators craft new studies and build programs of research focusing on problems that are amenable to change. Plant-ing the “so what” seeds is the fi rst step in growing a successful intervention study and program of research. Without this approach, we risk continuing to generate a large number of research fi ndings that are disseminated through publications and presen-tations but, to a large extent, do not make it into the real world to positively impact outcomes.

iMPACt, siGNiFiCANCE, ANd iNNoVAtioN: CritiCAL ELEMENts For iNtErVENtioN stUdiEs

Studies that address the “so what” factor often have high overall impact, signifi cance, and innovation. Impact is the probability of whether the study will exert a sustained powerful infl uence on the fi eld. The topic of signifi cance questions whether the study addresses an important problem or a critical barrier to progress in the fi eld, along with the question of “If the aims of the study are achieved, how will scientifi c knowledge, technical capability, and/or clinical practice be advanced?” Questions to consider when determining the innovation of your study include the following: (a) Does the project em-ploy novel concepts, approaches, or methods? (b) Are the aims original and innovative? and (c) Does the project challenge existing paradigms or develop new methodologies

tHE “so WHAt” FACtor iN iNtErVENtioN rEsEArCH

iMPACt, siGNiFiCANCE, ANd iNNoVAtioN: CritiCAL ELEMENts For iNtErVENtioN stUdiEs

4 i. designing intervention studies

or technologies? Other ways of looking at innovation include (a) the problem is one that has not been previously studied, (b) the solution has not been previously suggested, (c) the population has not been included in prior studies, (d) the outcomes have not been previously measured, and (e) the research methods have not been previously used (Sechrest & Babcock-Parziale, 2007). These three criteria (i.e., impact, signifi cance, and innovation) are frequently used by federal funders, including the National Institutes of Health (2011), when reviewing grant applications.

FiVE EssENtiAL iNGrEdiENts For CoNdUCtiNG iNtErVENtioN stUdiEs

There are 5 Ps that need to be considered as essential when launching an intervention study or program of experimental research. These include the following:

l Prevalence of the problem and the “so what” factor l Passion on the part of the investigator that is critical for engagement and

sustainability of the research program l Planning that includes the details necessary to conduct a scientifi cally rigorous

study l Persistence that is key to getting through all of the “character builders” that

accompany the conduct and funding of intervention work l Patience, a virtue developed through building a program of research that makes a

difference in outcomes

After considering the “so what” factor, the second and probably the most important element in embarking on intervention research is passion. An important quote to re-member when embarking on this type of research is that “nothing happens unless fi rst a dream” (Carl Sandburg). A dream of what it is that you want to accomplish through intervention research, specifi cally the impact or difference that you want to make in outcomes (e.g., decreasing depression rates in adolescents, reducing preterm birth, de-creasing length of hospital stay for critically ill patients, or improving graduation rates of at-risk students), is critical to ensuring success. Keeping that dream in front of you every day and keeping it bigger than your fears will assist you in overcoming the obsta-cles that you are sure to face along your journey. Many times, researchers are convinced by others to embark on a topic that they are not passionate about in order to respond to a funding opportunity. Although funding is essential to conduct most intervention stud-ies, the work will be laborious if you do not have passion for the research that you are embarking on. It is often possible to refi ne your study to an area of funding opportunity and still keep the passion alive for what is most important to you.

The third important element for conducting intervention studies is planning. Meticulous planning of every element of the study is necessary in order for successful implementation and completion. As part of the planning, it is critical to comprise a research team that is also passionate about the topic, dedicated to the project, and willing to “go the extra mile” to suc-cessfully complete the study. If you are a novice at intervention research, your team may consist of “me, myself, and I.” However, remember that you also can establish a team of colleagues and mentors to assist you with your early intervention work.

FiVE EssENtiAL iNGrEdiENts For CoNdUCtiNG iNtErVENtioN stUdiEs

Setting a goal is not the main thing. It is deciding how you will go about achieving it and staying with that plan.—Tom Landry

1. setting the stage for intervention research: the “so What” Factor 5

The fourth essential ingredient for conducting intervention research is persistence. Whether planning or im-plementing a study or writing a grant ap-plication to fund the research, there will no doubt be several character builders along the course of the way. These might include having to rewrite several institutional review board applications, grant application rejections, and unexpected participant attrition to name just a few. Thinking through potential barriers and generating strate-gies to overcome them before they occur and staying steadfast through the character builders is important for a study’s successful completion.

Finally, patience is a virtue that is necessary for designing, conducting, and fund-ing intervention work. Throughout the course of the study, whether it is obtaining human subjects’ approval, recruiting your sample, collecting data, training your research team, or following subjects over time, every aspect of intervention work provides plenty of opportunity to develop your staying power.

otHEr MAJor FACtors to CoNsidEr For iNtErVENtioN rEsEArCH

Feasibility of the study is another important consideration for intervention work. Ques-tions pertaining to feasibility should include the following: (a) Do you have the time to be lead or principal investigator on the project? (b) Can the study be conducted in a reasonable amount of time? (c) Are the sites in which you are proposing to conduct the study amenable to the project? (d) Will a suffi cient number of subjects be attainable to reach your study’s goal for sample size? (e) Is the intervention practical to administer and not overly burdensome to subjects? (f) Are study materials, such as instruments to measure outcomes, readily available or will they need to be designed? (g) Is there suf-fi cient funding for the study? and (h) Are you able to comprise a team with the skills and dedication needed to conduct the study?

Ethical issues are always an important aspect to consider when conducting inter-vention research. Specifi cally, you need to determine whether what you will be asking of the participants is ethical and does not lead to undue subject burden. The amount of subject burden as well as benefi ts of study participation is scrutinized heavily by members of an institutional review board along with grant reviewers. In particular, conducting intervention studies with vulnerable populations (e.g., prison popula-tions, pregnant women, children) presents its own challenges in assuring protection of human subjects. Specifi c issues regarding human subjects and ethical considerations are covered in detail in later chapters.

Level of ambitiousness of the project is another important consideration for in-tervention research. Many investigators propose to conduct intervention studies that are complex with large sample sizes in a short period of time or they try to achieve multiple study aims with a very limited budget. Being overly ambitious with a study can result in limited success of the project; that is why thoughtful planning up front is essential for intervention work. When planning an intervention study, think realistically rather than grandiose. As a general rule of thumb, it often takes twice as long to conduct each phase of the study than you think that it will. Obtaining the perspective of other investigators who have conducted similar work can provide you

otHEr MAJor FACtors to CoNsidEr For iNtErVENtioN rEsEArCH

Character consists of what you do on the third and fourth tries.—John Albert Michener

Patience, persistence, and perspiration make an unbeatable combination for success.—Napoleon Hill

6 i. designing intervention studies

with “guesstimates” of appropriate timelines for various study activities. However, remember that these perspectives will be infl uenced greatly based on whether the investigator already had an established team and ongoing relationships with study sites and the target population.

tHE “WHAt EXists” FACtor iN iNtErVENtioN rEsEArCH

After addressing the “so what” factor and its associated questions, it is critical to con-duct a thorough review and synthesis of the literature. This literature search will help you to determine the state of the science and how the study that you are proposing extends what is known in the fi eld. Most intervention research tests a new intervention or compares two interventions that have already been supported as effi cacious through prior research (i.e., comparative effectiveness trials). Intentionally replicating a prior intervention study is totally acceptable; in fact, replication studies are needed in order to generate systematic reviews , the strongest level of evidence (i.e., level 1 evidence ) needed to change clinical practice (Melnyk & Fineout-Overholt, 2011). However, “un-knowing replication” (i.e., repeating a prior study without knowledge that it has already been conducted because a thorough literature search was not performed) will place your project’s viability at risk and lead to character-building experiences. One such critical experience could be when grant reviewers point out that the study being pro-posed has already been completed and funding is denied due to lack of due diligence or minimal impact on the fi eld.

When conducting a thorough literature search, it is very helpful to fi rst formulate a PIcot (P 5 patient/participant population, I 5 intervention of interest, C 5 com-parison intervention, O 5 outcome, T 5 time) question (Melnyk & Fineout-Overholt, 2011). For example, “In premature infants (P), what is the effect of massage (I) versus music (C) on oxygen saturation (O) in the neonatal intensive care unit (T);” or “In overweight women (P), what is the effect of group walking classes (I) versus daily use of a pedometer (C) on body mass index (O) at 6 months (T)?” The PICOT format helps you to identify key words or phrases that, when entered successively and com-bined, expedite the locating of relevant articles in massive research databases, such as MEDLINE, CINAHL, ERIC or PsycINFO. For the second PICOT question posed on overweight women, the fi rst key phrase to be entered into the data base would be over-weight women , a subject so common that tens of thousands of citations and abstracts will be generated. The second term to be searched would be group walking classes , followed next by pedometer and the remaining keywords in the PICOT question. The fi nal step of the search is to combine the results of the searches for each of the terms previously entered. Using this strategy narrows the results to studies pertinent to the PICOT question. Use of a PICOT question to conduct a thorough literature search will result in a more expedited search and lead to the elimination of nontargeted stud-ies and those that are irrelevant to the question. Setting limits on the search, such as “English” or “human language,” also is helpful in eliminating animal studies or those published in foreign languages.

Once the literature search is conducted and studies pertinent to your area of inter-est are retrieved, it is useful to then place each study within a table that assists you in looking across the studies to identify similarities as well as differences (see Table 1.1). Following completion of the tabling of these published studies, it is important to syn-thesize the literature so that strengths and limitations of the body of prior work in the fi eld can be identifi ed. When this process is completed, you will more readily be able to describe how your proposed study will extend the science in the area.

tHE “WHAt EXists” FACtor iN iNtErVENtioN rEsEArCH

1. setting the stage for intervention research: the “so What” Factor 7

tHE “WHAt’s NEXt” FACtor: ForMULAtiNG rEsEArCH QUEstioNs ANd stUdY HYPotHEsEs

The next step after conducting the literature review is to formulate your research ques-tions and hypotheses. If there is very little or no prior work in the area, or if you will be testing a novel intervention for the fi rst time in a pilot study, you might only pose research questions for your study without hypotheses that provide predictive direction.

Characteristics of a well-formulated research question include one that

l addresses a signifi cant problem that is amenable to change, l is feasible, l is innovative, l focuses on a topic for which you have much passion, l is formatted in a way that will extend the science or knowingly replicate prior work, l is ethical, l clearly delineates the independent (intervention) and dependent (outcome)

variables, and, l is focused on a single question.

Examples of poorly and well formed research questions are included in Table 1.2. Hulley, Cummings, Browner, Grady, and Newman (2006) use the pneumonic FINER as a way to formulate research questions that represent feasible, interesting, novel, ethical, and relevant to clinical practice.

Some studies will pose primary and secondary research questions. In interven-tion studies, secondary research questions typically focus on explaining the process through which the intervention works (e.g., Do cognitive beliefs mediate the effects of the experimental intervention on healthy lifestyle behaviors?) or identifying factors that might moderate the effects of the experimental intervention (i.e., How does gender impact the effects of the experimental intervention on healthy lifestyle behaviors?).

Hypotheses

A hypothesis is a predictive statement about the relationship between variables. In intervention studies, the hypothesis delineates how you expect the experimental intervention to impact the study’s outcome(s). Hypotheses are used to establish the basis for tests of statistical signifi cance. Examples of hypotheses that fl ow from the re-search questions in Table 1.2 are outlined in Exhibit 1.1. In each of the examples, the

tHE “WHAt’s NEXt” FACtor: ForMULAtiNG rEsEArCH QUEstioNs ANd stUdY HYPotHEsEs

tABLE 1.1 recommended Format for tabling studies From the Literature review

AUtHor(s),titLE oF

stUdY ANd YEAr

PUrPosE oF stUdY ANd

CoNCEPtUALFrAMEWorK

sAMPLE ANd

sEttiNG

stUdY dEsiGN ANd

iNtErVENtioNs

oUtCoMEVAriABLEs

WitH MEAsUrEs FiNdiNGs

MAJor strENGtHs

ANd LiMitAtioNs

tABLE 1.1 tABLE 1.1 tABLE 1.1 tABLE 1.1

8 i. designing intervention studies

population of interest is clearly defi ned and the expected change in the outcome vari-able as a result of the treatment is delineated.

Whenever possible, hypotheses should be simple (i.e., containing one independent variable and one dependent variable) instead of complex, which means they contain more than one independent or dependent variable. For example, a complex hypoth-esis with two dependent variables is: High school students who receive two interactive classes on anger management versus those who watch a video on anger management will report less anger and have fewer disruptive behaviors in the classroom. Complex hypotheses are not readily testable with one statistical test, which is why it is more fa-vorable to compose single hypotheses.

EXHiBit 1.1 Examples of Well Formulated Hypotheses

Preschool children (the designated population) whose parents receive one-on-one counseling from a primary care provider (the experimental intervention/independent variable) versus group counseling (the comparison intervention/independent vari-able) have fewer behavior problems 3 months after the intervention (the outcome/dependent variable).

Overweight women (the designated population) who exercise 3 times per week (the experimental intervention/independent variable) versus those who exercise once a week (the comparison intervention/independent variable) will have more weight loss at 6 months follow-up (the outcome/dependent variable).

Overweight women (the designated population) who exercise 3 times per week (the experimental intervention/independent variable) versus those who exercise once a week (the comparison intervention/independent variable) will have better self- concept at 6 months follow-up (the outcome/dependent variable).

Depressed adults who receive Prozac (the experimental intervention/independent variable) versus those who receive a placebo (the control condition) will have fewer depressive symptoms at 4 months follow-up (the outcome/dependent variable).

tABLE 1.2 Examples of Poorly and Well Formed research Questions

PoorLY ForMEd rEsEArCH QUEstioNs WELL ForMEd rEsEArCH QUEstioNs

How does counseling of parents by a primary care provider affect children?

In preschool children with behavior problems, what is the effect of one-on-one counseling of parents by a primary care provider versus group counseling on the children’s behavior problems?

How would exercise affect women’s self-worth and body fat?

In overweight women, what is the effect of exer-cise 33 weekly versus exercise once a week on weight loss?

In overweight women, what is the effect of exer-cise 33 weekly versus exercise once a week on their self-worth?

Is it effective to provide SSRIs to adults with depression?

In depressed adults, what is the effect of Prozac versus a placebo on depressive symptoms?

SSRI = selective serotonin reuptake inhibitor.

tABLE 1.2 tABLE 1.2 tABLE 1.2 tABLE 1.2

1. setting the stage for intervention research: the “so What” Factor 9

Intervention research provides you with the opportunity to have a profound im-pact on outcomes and the things that matter most to you. Along with the excitement of developing and disseminating new knowledge from your research come the character building experiences faced by every investigator. Carefully incorporating the “so what,” “what exists,” and “what’s next” factors as you are beginning your work allows for your study to remain relevant, focused, and impactful; these characteristics are critical for designing, conducting, and analyzing intervention work. Including these critical com-ponents will enhance your chances of successful funding as well. The 5 Ps (prevalence, passion, planning, persistence, patience) should be the fi rst items you place in your “intervention suitcase” of knowledge and skills. Now let’s get going—we have many stops along the journey we will take in this book. Your suitcase will be fi lled with ideas and advice at the end of your trip so that you can be highly successful with intervention research and in accomplishing your dreams.

Key Points From this Chapter

There exists a major gap between available evidence-based interventions and the health, social, and educational needs of society.

Experimental studies are the only type of research that supports intervention cause and effect relationships.

The “so what” factor addresses problem prevalence, signifi cance, impact, and translatability.

The “what exists” factor addresses the need to assess the state of the science by conducting a thorough literature review using the PICOT method of forming the question to guide the search.

The “what’s next” factor targets the need for focused, clearly delineated research questions and hypotheses.

Prevalence, passion, planning, persistence, and patience are essential ingredients for successful intervention work.

rEFErENCEs

Hulley, S. B., Cummings, S. R., Browner, W. S., Grady, D., & Newman, T. B. (2006). Designingclinical research (3rd ed.). Philadelphia, PA: Lippincott Williams & Wilkins.

Melnyk, B. M., & Fineout-Overholt, E. (2011). Evidence-based practice in nursing & healthcare: A guide to best practice . Philadelphia, PA: Wolters Kluwer/Lippincott Williams & Wilkins.

National Institutes of Health. (2011). Defi nitions of criteria and considerations for research project grant (RPG/R01/R03/R15/R21) critiques . Retrieved from http://grants.nih.gov/grants/peer/critiques/rpg.htm#rpg_03

Sechrest, L., & Babcock-Parziale, J. B. (2007). Writing effective research proposals . Fairfax, VA: Public Interest Research Services.

rEFErENCEs