Introduction to health research methods

INTRODUCTION TO HEALTH RESEARCH METHODS A Practical Guide SECOND EDITION Kathryn H Jacobsen, MPH, PhD Professor George Mason University Fairfax, Virginia JONES & BARTLETT LEARNING Copyright Page World Headquarters Jones & Bartlett Learning Wall Street Burlington, MA 01803 978-443-5000 info@jblearning.com www.jblearning.com Jones & Bartlett Learning books and products are available through most bookstores and online booksellers To contact Jones & Bartlett Learning directly, call 800-832-0034, fax 978-443-8000, or visit our website, www.jblearning.com Substantial discounts on bulk quantities of Jones & Bartlett Learning publications are available to corporations, professional associations, and other qualified organizations For details and specific discount information, contact the special sales department at Jones & Bartlett Learning via the above contact information or send an email to specialsales@jblearning.com Copyright © 2017 by Jones & Bartlett Learning, LLC, an Ascend Learning Company All rights reserved No part of the material protected by this copyright may be reproduced or utilized in any form, electronic or mechanical, including photocopying, recording, or by any information storage and retrieval system, without written permission from the copyright owner The content, statements, views, and opinions herein are the sole expression of the respective authors and not that of Jones & Bartlett Learning, LLC Reference herein to any specific commercial product, process, or service by trade name, trademark, manufacturer, or otherwise does not constitute or imply its endorsement or recommendation by Jones & Bartlett Learning, LLC and such reference shall not be used for advertising or product endorsement purposes All trademarks displayed are the trademarks of the parties noted herein Introduction to Health Research Methods: A Practical Guide, Second Edition is an independent publication and has not been authorized, sponsored, or otherwise approved by the owners of the trademarks or service marks referenced in this product There may be images in this book that feature models; these models not necessarily endorse, represent, or participate in the activities represented in the images Any screenshots in this product are for educational and instructive purposes only Any individuals and scenarios featured in the case studies throughout this product may be real or fictitious, but are used for instructional purposes only This publication is designed to provide accurate and authoritative information in regard to the Subject Matter covered It is sold with the understanding that the publisher is not engaged in rendering legal, accounting, or other professional service If legal advice or other expert assistance is required, the service of a competent professional person should be sought 09453-4 Production Credits VP, Executive Publisher: David D Cella Publisher: Michael Brown Associate Editor: Lindsey M Sousa Senior Vendor Manager: Tracey McCrea Senior Marketing Manager: Sophie Fleck Teague Manufacturing and Inventory Control Supervisor: Amy Bacus Project Management & Composition: Integra Software Services Pvt Ltd Cover Design: Kristin E Parker Rights & Media Specialist: Merideth Tumasz Media Development Editor: Shannon Sheehan Cover Image: © neelsky/Shutterstock Printing and Binding: Edwards Brothers Malloy Cover Printing: Edwards Brothers Malloy Library of Congress Cataloging-in-Publication Data Names: Jacobsen, Kathryn H., author Title: Introduction to health research methods : a practical guide / Kathryn H Jacobsen Description: 2nd edition | Burlington, MA : Jones & Bartlett Learning, [2017] | Includes index Identifiers: LCCN 2016023372 | ISBN 9781284094534 (pbk.) Subjects: | MESH: Biomedical Research—methods | Research Design Classification: LCC R850 | NLM W 20.5 | DDC 610.72—dc23 LC record available at https://lccn.loc.gov/2016023372 6048 Printed in the United States of America 20 19 18 17 16 10 CONTENTS Preface About the Author What’s New in the Second Edition Chapter The Health Research Process 1.1 The Research Process 1.2 Health Research 1.3 Health Research Purposes 1.4 Book Overview STEP 1: IDENTIFYING A STUDY QUESTION Chapter Selecting a General Topic 2.1 Practical Questions 2.2 Brainstorming and Concept Mapping 2.3 Keywords 2.4 Exposure, Disease, Population (EDP) 2.5 PICOT Chapter Reviewing the Literature 3.1 Informal Sources 3.2 Statistical Reports 3.3 Abstract Databases 3.4 Full-Text Articles 3.5 Critical Reading 3.6 Annotated Bibliographies 3.7 What Makes Research Original? Chapter Focusing the Research Question 4.1 Study Approach 4.2 Conceptual and Theoretical Frameworks 4.3 Study Goal and Specific Objectives 4.4 Checklist for Success Chapter Collaboration and Mentorship 5.1 Collaborators and Consultants 5.2 Finding Research Mentors 5.3 The Mentor–Mentee Relationship 5.4 Professional Development Chapter Coauthoring 6.1 Coauthorship program, 93 program evaluation, 93 project, 92–93 project evaluation, 93 project narrative, 207 propensity score matching, 270–271 proportionate mortality rate, 44 proposals, 205–212 prospective cohort study, 61–63 prospective study, 61 protected health information (PHI), 221 protocol, 103–107 provisional acceptance, 343 psychometrics, 142 PsycIFNO, 15 publication bias, 177, 179–180 publication ethics authorship criteria, 32–33 duplicate publication, 322 plagiarism, 233, 302 publicly available data sets, 161 publishing costs, 325–326 page proofs, 343 peer review, 320, 337–339 reasons to publish, 319–322 resubmission, 340–343 submission process, 334 PubMed, 14 purposive sampling, 90 p-value, 239–240 Q Q statistic, 178 QALY, 271 QoL, 74, 271 qualitative interviewing methods, 89–90 qualitative research, 87–93 approaches, 88 techniques, 89 theories, 87–89 quality-adjusted life years (QALYs), 271 quality control, 160 quality of life (QoL), 74, 271 quantitative research, 88–89 quartiles, 227 quasi-experimental design, 79–80 questionnaire, 129–145 anonymity, 133–134 content, 130–131 development, 129–145 layout, 140–141 order, 136–139 pilot testing, 145 response options, 131–135 translation, 144–145 validity, 141–144 wording, 136 quoting, 299, 301 R random-digit dialing, 147 random effects model, 178 randomization, 79–80 randomized controlled trial (RCT), 71–72 range, 227 ranked variable, 224–225 comparative statistics, 247–248, 250 descriptive statistics, 226, 228, 231–232 rank-order variable, 224–225 rate ratio, 68–70 ratio variable, 224–226 comparative statistics, 246–251, 259–262 descriptive statistics, 224, 228 RCR, 193 RCT (randomized controlled trial), 71–72 realist synthesis, 93 recalculating, data, 220–221 recall bias, 52 receiver operating characteristic (ROC) curves, 85 recoding of variables, 220–221 reconciliation of a budget, 212 recruiting methods, 148–150 recursive model, 265 redundant publication, 322 reference group, 241–242 reference list, 293, 297, 303–304, 331 reference standard, 83 reference styles, 303, 331 regression modeling, 253–268 reimbursement, 183 reject and resubmit (R&R), 340 rejection of a manuscript, 339–340 relationship, mentor–mentee, 29 relative rate, 69–70 relative risk, 69–70 reliability, 141–144 repeated cross-sectional surveys, 47 repeated-measures ANOVA, 250 replication study, 17 reporting guidelines, 289 representative populations, 45–46 representativeness, 45–46 request for applications (RFA), 206–207 request for proposals (RFP), 206–207 research, definition, research ethics, 25, 181–193 “8 Cs” in, 184–185 autonomy, 182 beneficence, 182 case series, 44, 164, 165–166 case-control study, 49 communities, 119, 185–186 confidentiality, 190–191 conflicts of interest, 184, 193 cross-sectional study, 119 cultural considerations, 192 distributive justice, 183 experimental study, 77–78, 80–81 inducements, 150, 183–187 informed consent, 187–190 IRBs, 195–204 nonmaleficence, 182–183 photography, 44 publication ethics, 302, 330 qualitative research, 89 respect for persons, 182 training, 107, 152, 193 voluntariness, 187 research ethics committees (RECs), 195 research mentors, 28–29 research misconduct, 193, 233, 302 research plans by study approach, 103–104 research populations, types of, 109 research process, 1, 311 research proposals, 205–212 research protocols, 103–107 research question checklist for success, 24–25 conceptual and theoretical frameworks, 22 study approach, 21–22 study goal and specific objectives, 23–24 research timelines, 103–105 researcher responsibilities, 105–106 residual, 255 respect for persons, 182 responding to reviewer comments, 340–343 response scales, 135 responsible conduct of research (RCR), 193 resubmission, 341–343 results section, 288, 292 retention, 64–65 retraction, 302 retrospective cohort study, 61–63 review ethics committee, 195–204 manuscript, 337–339 reviewer comments, sample responses to, 340–343 revise and resubmit (R&R), 341–343 risk assessment, risk factor, 68 risk ratio, 68–70 ROC curves, 85 RR, 68–70 R&R, 341–343 S salami publication, 306 sample mean, 246 sample population, 109 methods for contacting members of, 147 sample size, 121–123 estimation, 123–125 importance of, 121 power estimation, 125–127 refining study approach, 127–128 sample size calculation, 123–125 sampling, 90, 110–112 sampling bias, 111 sampling frame, 110 scatterplot, 97–98, 254 SciELO (Scientific Electronic Library Online), 14 scientific dialogue, 319 screening tests, 83–86 search limiters, 173–174 search strings, 171–173 second author, 33 secondary analysis, 21–22, 37–39, 64, 95, 104, 161–166 selecting a research question, 7–12, 17–19, 168–170 selection bias, 79 self-administered surveys, 147–148, 155 self-response questionnaire, 140 SEM, 265 semi-structured interview, 89 senior author, 33 senior researcher, 27 sensitive issues, 191 sensitivity, 85–86 sensitivity analysis, 268, 270 sign test for matched pairs, 250 significance level, 239, 243–244 significant figures, 294 simple linear regression, 254–256 simple logistic regression, 256–257 simple random sampling, 111 simple randomization, 79 simultaneous multiple regression, 253 single-blind study, 78 SIR models, 269 skewness, 229 skips, 140 snowballing, 176 social media analysis, 165 solicited proposal, 207 source population, 109–110 spatial analysis, 269 Spearman rank-order correlation, 98, 247 specific aims, 23–24 specific knowledge, 299–302 specific objectives, 23–24 specificity, 85–86 spread, 227 spreadsheet program, 218 standard deviation, 229–231 standard error, 229–230 standard of care, 77 statistical honesty, 233–234 statistical power, 121, 125–127 statistical tests, hypotheses for, 237 stepwise multiple regression, 253 stochastic model, 270 stratified randomization, 79–80 stratified sampling, 79 STROBE checklist, 287, 289 structural equation modeling (SEM), 265 structure and content of research paper, 306–308 structured abstract, 287 study approaches, overview, 21–22, 37–40 study goal, 23–24 study population, 109–110, 112 style checklist, 308 submission fee, 326 submission process, 334–335 success in a trial, 74 summary statistic (in meta-analysis), 177–178 superiority trial, 73–74 surveillance, 64 survey instrument, 129–145 surveys, 147–154 data recording methods, 151–152 interviews vs self-administered, 147–148 recruiting methods, 148–150 survival analysis, 266–267 SWOT analysis, 93 systematic review, 170–171 eligibility criteria, 174–176 overview, 167–168 results, 176–177 systematic sampling, 111 systematic search strategy, 175 T tables, 294–296 talk-aloud protocol, 89 target journal, 323 aim, scope, and audience, 323–324 impact factors and indexing, 324–325 predatory journals, 326–327 publication fees and open access, 325–326 target population, 109–110 telephone interviews, 141 tertiary study, 21–22, 37–38 tertile, 227 test of comprehension, 184, 189 test statistic, 248 testability, test-retest reliability, 142 text mining, 165 themes, 92 theoretical concept, 22–23 theoretical framework, 22 thesaurus plagiarism, 302 think-aloud protocol, 89 third variable, 257 time series study, 64 tolerance index, 261–262 topic selection brainstorming and concept mapping, 8–9 exposure, disease, population (EDP), 10–12 keywords, PICOT, 12 practical questions, 7–8 training interviewers, 152–154 transcription, 90–91 transformative paradigm, 89 translation, 144–145 treatment-assigned analysis, 83 treatment-assigned approach, 83 treatment received analysis, 83 TREND checklist, 289 t-test, 246 two-by-two table, 53 for cohort studies, 69–70 for experimental studies, 241 for matched case-control studies, 57 for screening tests, 83–86 for unmatched case-control studies, 53 two-sample t-test, 246–247 two-sided p-value, 240 two-way ANOVA, 259 type error, 125–127, 239 type error, 125–127 types of questions, 131–133 types of responses, 134–135 U understood consent, 189 uniform distribution, 229 unimodal distribution, 229 univariate analysis, 223 unstructured abstract, 287 V validation, 143–144 validity, 141–144 Vancouver reference style, 303 variability, 178, 277 variables, types of, 224–226 variance, 229–231 variance inflation factor (VIF), 262 verbal consent, 190 vital signs, 156 vital statistics, 14 voluntariness, 187 volunteer bias, 79 volunteer recruitment, 182 vulnerable populations, 118–119, 193 W waiver, 191 Wald statistic, 257 washout period, 78 weighting, 98–100, 178 white space (blank areas), 140 Wilcoxon rank sum test, 247 Wilcoxon signed-rank test, 250 word limits, 306–308, 325, 332 wording of questions, 136 World Health Organization (WHO), 13 writer’s block, 312–315 writing avoidance, 312–315 checklists, 287, 289 editing a manuscript, 305–308 research paper, 287–293, 305–308 research proposal, 205–210 research protocol, 103–107 strategies for success, 309–317 writing style, 298–299, 305–308 writing throughout the research process, 311 writing groups, 312 writing process, typical variations in productivity during, 310 writing strategies, 315–317 getting started, 309–312 staying motivated, 312 writer’s block, 312–317 writing process, 309 written consent, 189–190 Y years lived with disability (YLD), 271 years of life lost (YLL), 271 Z z-score, 230 ... entire process The best way to learn about health research is to actual research and to learn firsthand how the research process works As a research project unfolds, most researchers will benefit... is also the author of Introduction to Global Health (Jones & Bartlett Learning) WHAT’S NEW IN THE SECOND EDITION In this second edition of Introduction to Health Research Methods, every chapter... used for health policy and practice 1.3 Health Research Purposes Research in the population health sciences often seeks to answer questions about community health profiles, risk factors for disease,