Abstract
Research methods commonly used in social sciences are appropriate for studies of how people deal with “risk” and for studies of risk communication. These approaches can be applied to understanding and appraising risk communications about medicines. This chapter reviews appropriateness and potential of social science research methods for this purpose, focusing on:
-
qualitative studies (e.g. of experiences of a risk communication, or to create a theoretical conceptualisation or model of a risk communication);
-
surveys for studying prevalence (e.g. of health behaviours or attitudes) and correlations (e.g. between communication types and health behaviours);
-
(quasi-)experimental studies and intervention trials (for measuring effects of planned risk communication interventions); and
-
mixed-method studies (combining features of the above designs).
The chapter explains the main features of these methods; discusses their strengths and limitations; considers examples; and makes suggestions for applying the methods effectively to improve the evidence base on risk communication about medicines. The chapter emphasises the distinctly different types of research question that are appropriate for each of these research designs.
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsNotes
- 1.
Studies included in the review are indicated by an asterisk (∗).
References
Studies included in the review are indicated by an asterisk (∗).
Akl EA, Oxman AD, Herrin J, Vist GE, Terrenato I, Sperati F, Costiniuk C, Blank D, Schünemann H (2011) Using alternative statistical formats for presenting risks and risk reductions. Cochrane Database Syst Rev 3:CD006776. https://doi.org/10.1002/14651858.CD006776.pub2
Altman DG (1991) Practical statistics for medical research. Chapman and Hall, London
∗Andreas DC, Abraham NS, Naik AD, Street RL Jr, Sharf BF (2010) Understanding risk communication through patient narratives about complex antithrombotic therapies. Qual Health Res 20(8):1155–1165. https://doi.org/10.1177/1049732310370154
Auspurg K, Hinz T (2014) Factorial survey experiments. Sage, London
Australian Council for International Development (2016) Principles and guidelines for ethical research and evaluation in development. ACFID, Canberra
Bahri P (2010) Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies. Drug Saf 33(12):1065–1079. https://doi.org/10.2165/11539040-000000000-00000
Bahri P, Fogd J, Morales D, Kurz X, ADVANCE Consortium (2017) Application of real-time global media monitoring and ‘derived questions’ for enhancing communication by regulatory bodies: the case of human papillomavirus vaccines. BMC Med 15:91. https://doi.org/10.1186/s12916-017-0850-4
Bailar JC, Louis TA, Lavori PW, Polansky M (1986) A classification for biomedical research reports. N Engl J Med 311:1482–1487. https://doi.org/10.1056/NEJM198412063112305
Bates J, Best P, McQuilkin J, Taylor BJ (2017) Will web search engines replace bibliographic databases in the systematic identification of research? J Acad Libr 43(1):8–17. https://doi.org/10.1016/j.acalib.2016.11.003
∗Belcora JK, Hutton DW, Moore DH, Siminoff LA (2011) Does use of the ‘adjuvant!’ Model influence use of adjuvant therapy through better risk communication? J Natl Compr Cancer Netw 9:707–712. https://doi.org/10.6004/jnccn.2011.0061
∗Berry DC, Knapp PR, Raynor T (2002) Is 15 per cent very common? Informing people about the risks of medication side effects. Int J Pharm Pract 10:145–151. https://doi.org/10.1111/j.2042-7174.2002.tb00602.x
Best P, Taylor BJ, Manktelow R, McQuilkin J (2014) Systematically retrieving research in the digital age: case study on the topic of social networking sites and young people’s mental health. J Inf Sci 40:346–356. https://doi.org/10.1177/0165551514521936
Bickman L, Rog DJ (eds) (2008) The sage handbook of applied social research methods, 2nd edn. Sage, Thousand Oaks
Bilgin B, Brenner L (2013) Context affects the interpretation of low but not high numerical probabilities: a hypothesis-testing account of subjective probability. Organ Behav Hum Decis Process 121:118–128. https://doi.org/10.1016/j.obhdp.2013.01.004
Bland M (2015) An introduction to medical statistics, 4th edn. Oxford University Press, Oxford
Blomgren KJ, Sundström A, Steineck G, Wilholm BE (2006) Interviewer variability: quality aspects in a case-control study. Eur J Epidemiol 21(4):267–277. https://doi.org/10.1007/s10654-006-0017-7
Bors D (2018) Data analysis for the social sciences: integrating theory and practice. Sage, London
Brewer J (2000) Ethnography. Open University, Buckingham
∗Brewer NT, Tzeng JP, Lillie SE, Edwards AS, Peppercorn JM, Rimer BK (2009) Health literacy and cancer risk perception: implications for genomic risk communication. Med Decis Mak 29(2):157–166. https://doi.org/10.1177/0272989X08327111
Bryman A (2016) Social research methods, 5th edn. Oxford University Press, Oxford
Butcher RB, Fechtelpeter D, Knelangen M, Ehrlichg M, Waltering A (2014) Words or numbers? Communicating risk of adverse effects in written consumer health information: a systematic review and meta-analysis. BMC Med Inform Decis Mak 14:76–87. https://doi.org/10.1186/1472-6947-14-76
Campbell A, Taylor BJ, McGlade A (2016) Research design in social work: qualitative and quantitative methods. Sage, London
Carson D, Bain A (2008) Professional risk and working with people: decision-making in health, social care and criminal justice. Jessica Kingsley, London
Centre for Reviews and Dissemination (CRD) (2009) Systematic reviews: CRD’s guidance for undertaking reviews in health care, 3rd edn. Centre for Reviews and Dissemination, University of York. www.york.ac.uk/crd/
Charmaz K (2014) Constructing grounded theory: a practical guide through qualitative analysis, 2nd edn. Sage, New York
Coggon D, Barker DJP, Rose G (2003) Epidemiology for the uninitiated, 5th edn. British Medical Journal, London
Council of the European Communities (1992) Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets. (Extended to the EEA by 21994D0628(01) SYN 231). Brussels: Official Journal
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M (2008) Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ 337:a1655. https://doi.org/10.1136/bmj.a1655
Cresswell JW, Plano VL (2010) Designing and conducting mixed methods research, 2nd edn. Sage, London
Critical Appraisal Skills Programme (CASP) (1998) CASP checklists. Critical Appraisal Skills Programme, Oxford. http://www.casp-uk.net. Accessed 22 June 2017
Datta J, Petticrew M (2013) Challenges to evaluating complex interventions: a content analysis of published papers. BMC Public Health 13:568. https://doi.org/10.1186/1471-2458-13-568
∗Davis JJ (2007) Consumers’ preferences for the communication of risk information in drug advertising. Health Aff 26(3):863–870. https://doi.org/10.1377/hlthaff.26.3.863
∗Davis TC, Fredrickson DD, Kennen EM, Humiston SG, Arnold CL, Quinlin MS, Bocchini JA (2006) Vaccine risk/benefit communication: effect of an educational package for public health nurses. Health Educ Behav 33:787–801. https://doi.org/10.1111/j.0737-1209.2004.021305.x
∗Davis JJ, Cross E, Crowley J (2007) Pharmaceutical websites and the communication of risk. J Health Commun 12(1):29–39. https://doi.org/10.1080/10810730601091326
Department of Health and Human Services. Office of Inspector General (2013) FDA lacks comprehensive data to determine whether risk evaluation and mitigation strategies improve drug safety. Department of Health and Human Services, Office of Inspector General, Washington. https://oig.hhs.gov/oei/reports/oei-04-11-00510.pdf. Accessed 22 Jan 2018
Dodoo A, Hugman B (2012) Risk perception and communication in sub-Saharan Africa. Drug Saf 35(11):1041–1052. https://doi.org/10.2165/11636270-000000000-00000
Dusetzina SB, Higashi AS, Dorsey ER, Conti R, Huskamp HA, Zhu S, Garfield CF, Alexander GC (2012) Impact of FDA drug risk communications on healthcare utilization and health behaviors: a systematic review. Med Care 50(6):466–478. https://doi.org/10.1097/MLR.0b013e318245a160
Economic and Social Research Council (2016) What is social science? Economic and Social Research Council, London. http://www.esrc.ac.uk/about-us/what-is-social-science/
Edwards A, Elwyn G, Covey J, Matthews E, Pill R (2001) Presenting risk information a review of the effects of framing and other manipulations on patient outcomes. J Health Commun 6:61–82. https://doi.org/10.1080/10810730150501413
Edwards AGK, Naik G, Ahmed H, Elwyn GJ, Pickles T, Hood K, Playle R (2013) Personalised risk communication for informed decision making about taking screening tests. Cochrane Database Syst Rev 2:CD001865. https://doi.org/10.1002/14651858.CD001865.pub3
Elliot R, Fisher CT, Rennie DL (1999) Evolving guidelines for publication of qualitative research studies in psychology & related fields. Br J Clin Psychol. 38:215–219 [Erratum: Br J Clin Psychol. 2000;39:1:10]
Elwyn G, Frosch D, Thomson R, Joseph-Williams N, Lloyd A, Kinnersley P, Cording E, Tomson D, Dodd C, Rollnick S, Edwards A, Barry M (2012) Shared decision making: a model for clinical practice. J Gen Intern Med 27(10):1361–1367. https://doi.org/10.1007/s11606-012-2077-6
Engel RJ, Schutt RK (2013) The practice of research in social work, 3rd edn. Sage, Thousand Oaks
European Medicines Agency (2012) Guideline on good pharmacovigilance practices (GVP). Module V—risk management systems (rev 1). European Medicines Agency, London. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf. Accessed 24 Jan 2018
European Medicines Agency (2013) Guideline on good pharmacovigilance practices (GVP). Module XVI—risk minimisation measures: selection of tools and effectiveness indicators. European Medicines Agency, London. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/06/WC500144010.pdf. Accessed 24 Jan 2018
European Medicines Agency (2017a) Guideline on good pharmacovigilance practices (GVP): annex I – definitions (rev 4). EMA/876333/2011 Rev 4∗. European Medicines Agency, London
European Medicines Agency (2017b) Guideline on good pharmacovigilance practices (GVP): module XVI: risk minimisation measures: selection of tools and effectiveness indicators (rev 2). European Medicines Agency, London
European Medicines Agency (2017c) Guideline on good pharmacovigilance practices (GVP): module VIII: post-authorisation safety studies (rev 3). [EMA/813938/2011 Rev 3∗]. European Medicines Agency, London 2017
European Medicines Agency Benefit-risk Methodology Project Team (2011) Work package 1 report: description of the current practice of benefit-risk assessment for centralised procedure products in the EU regulatory network: EMA/227124/2011. European Medicines Agency, London
European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) (2018) Guide on methodological standards in pharmacoepidemiology (revision 7). EMA/95098/2010. European Medicines Agency, London
Eysenbach G (2004) Improving the quality of web surveys: the checklist for reporting results of internet e-surveys (CHERRIES). J Med Internet Res 6(3):e34. https://doi.org/10.2196/jmir.6.3.e34 [Erratum: J Med Internet Res. 2012; 14(1): e8. https://doi.org/10.2196/jmir.2042]
Feynman RP (1999) The pleasure of finding things out. Helix (Perseus), Cambridge
Fischoff B, Brewer NT, Downs JS (eds) (2011) Communicating risks and benefits: an evidence-based users’ guide. Food and Drugs Administration, Silver Spring
Food and Drug Administration (2005) Guidance for industry: development and use of risk minimization action plans. Food and Drug Administration, Rockville. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126830.pdf. Accessed 24 Jan 2018
Food and Drug Administration (2007) Food and Drug Administration Amendment Act of 2007. http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/foodanddrugadministrationamendmentsactof2007/default.htm. Accessed 24 Jan 2018
Food and Drug Administration (2009) Guidance for industry: format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications draft guidance 2009. Food and Drug Administration, Rockville. http://www.fda.gov/downloads/Drugs/Guidances/UCM184128.pdf. Accessed 22 Jan 2018
Fry RB, Ray MN, Cobaugh DJ, Weissman NW, Kiefe CI, Shewchuk RM, Saag KG, Curtis JR, Allison JJ (2007) Racial/ethnic disparities in patient-reported nonsteroidal antiinflammatory drug (NSAID) risk awareness, patient-doctor NSAID risk communication, and NSAID risk behavior. Arthritis Rheum 57(8):1539–1545. https://doi.org/10.1002/art.23084
Fugard AJB, Potts HWW (2015) Supporting thinking on sample sizes for thematic analyses: a quantitative tool. Int J Soc Res Methodol 18:669–684. https://doi.org/10.1080/13645579.2015.1005453
∗Gaissmaier W, Anderson BL, Schulkin J (2014) How do physicians provide statistical information about antidepressants to hypothetical patients? Med Decis Mak 34:206–215. https://doi.org/10.1177/0272989X13501720
Gale NK, Heath G, Cameron E, Rashid S, Redwood S (2013) Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol 13:117. https://doi.org/10.1186/1471-2288-13-117
Galesic M, Gigerenzer G, Straubinger N (2009) Natural frequencies help older adults and people with low numeracy to evaluate medical screening tests. Med Decis Mak 29:368–371. https://doi.org/10.1177/0272989X08329463
Gee JP (2005) An introduction to discourse analysis: theory and method. Routledge, London
Gellin BG, Maibach EW, Marcuse EK (2000) Do parents understand immunizations? A national telephone survey. Pediatrics 106(5):1097–1102. https://doi.org/10.1542/peds.106.5.109
Gigerenzer G, Edwards A (2003) Simple tools for understanding risks: from innumeracy to insight. BMJ 327(7417):741–744. https://doi.org/10.1136/bmj.327.7417.741
Glaser B, Strauss A (1999) The discovery of grounded theory: strategies for qualitative research. Aldine de Gruyter, New York
Goedecke T, Morales D, Pacurariu A, Kurz X (2018) Measuring the impact of medicines regulatory interventions: systematic review and methodological considerations. Br J Clin Pharmacol 84(3):419–433. https://doi.org/10.1111/bcp.13469
Granger MM, Fischhoff B, Bostrom A, Atman CJ (2001) Risk communication: a mental models approach. Cambridge University Press, Cambridge
Greenhalgh T (2014) How to read a paper: the basics of evidence-based medicine, 5th edn. Wiley and BMJ Books, Chichester
Gridchyna I, Cloutier AM, Nkeng L, Craig C, Frise S, Moride Y (2014) Methodological gaps in the assessment of risk minimization interventions: a systematic review. Pharmacoepidemiol Drug Saf 23(6):572–579. https://doi.org/10.1002/pds.3596
Gumucio S (2011) Data collection: quantitative methods: the KAP survey model (Knowledge, Attitude & Practices). Médecins du Monde, Paris
∗Han PKJ, Joekes K, Elwyn G, Mazor KM, Thomson R, Sedgwick P, Ibison J, Wong JB (2014) Development and evaluation of a risk communication curriculum for medical students. Patient Educ Couns 94:43–49. https://doi.org/10.1016/j.pec.2013.09.009
Hanley B, Bradburn J, Barnes M, Evans C, Goodare H, Kelson M, Kent A, Oliver S, Thomas S, Wallcraft J (2004) Involving the public in National Health Service, public health, and social care research: briefing notes for researchers. INVOLVE Support Unit, London
Health Research Authority (2016) Defining research. National Health Service, HRA, London
Heins H (1976) A KAP (knowledge-attitude-practice) approach to the regionalization of perinatal health. J Ark Med Soc 73(6):229–234
Hertwig R, Erev I (2009) The description-experience gap in risky choice. Trends Cogn Sci 13:517–523. https://doi.org/10.1016/j.tics.2009.09.004
Higgins JPT, Green S (eds) (2011) Cochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0. The Cochrane Collaboration
Hill AB (1965) The environment and disease: association or causation? Proc R Soc Med 58(5):295–300
Hinneburg J, Ellermann C (2016) Antibiotics for acute middle ear infection in children: fact box. Harding Centre for Risk Literacy at the Max Planck Institute for Human Development, Berlin. https://www.harding-center.mpg.de/en/fact-boxes/use-of-antibiotics/acute-middle-ear-infection. Accessed 24 Jan 2018
∗Hutton DW, Belkora JK, Shachter RD, Moore DH (2009) Are patients getting the ‘gist’ in risk communication? Patient understanding of prognosis in breast cancer. J Cancer Educ 24:194–199. https://doi.org/10.1080/08858190902876452
∗Ilic D, Murphy K, Green S (2012) Risk communication and prostate cancer: identifying which summary statistics are best understood by men. Am J Mens Health 6(6):497–504. https://doi.org/10.1177/1557988312453616
INVOLVE (2012) Briefing notes for researchers: public involvement in NHS, public health and social care research. National Institute for Health Research, London
INVOLVE (2013) Exploring the impact of public involvement on the quality of research: examples. National Institute for Health Research, London
Juanchich M, Sirota M (2013) Do people really say it is “likely” when they believe it is only “possible”? Effect of politeness on risk communication. Q J Exp Psychol 66:1268–1275. https://doi.org/10.1080/17470218.2013.804582
Kalet A, Roberts JC, Fletcher R (1994) How do physicians talk with their patients about risks? J Gen Intern Med 9:402–404. https://doi.org/10.1007/BF02629523
∗Keller C, Siegrist M (2009) Effect of risk communication formats on risk perception depending on numeracy. Med Decis Mak 29(4):483–490. https://doi.org/10.1177/0272989X09333122
∗Kennedy A, Glasser J, Covello V, Gust D (2008) Development of vaccine risk communication messages using risk comparisons and mathematical modelling. J Health Commun 13:793–807. https://doi.org/10.1080/10810730802487463
Killick C, Taylor BJ (2012) Judgments of social care professionals on elder abuse referrals: a factorial survey. Br J Soc Work 42:814–832. https://doi.org/10.1093/bjsw/bcr109
∗Kirkegaard P, Edwards AGK, Hansen B, Hansen MD, Jensen MSA, Lauritzen T, Risoer MGB, Thomsen JL (2010) The RISAP-study: a complex intervention in risk communication and shared decision-making in general practice. BMC Fam Pract 11:70. https://doi.org/10.1186/1471-2296-11-70
Kuper A, Lingard L, Levinson W (2008) Critically appraising qualitative research. BMJ 337:a1035. https://doi.org/10.1136/bmj.a1035
∗Langlois-Klassen D, Kipp W, Rubaale T (2008) Who’s talking? Communication between health providers and HIV-infected adults related to herbal medicine for AIDS treatment in western Uganda. Soc Sci Med 67(1):165–176. https://doi.org/10.1016/j.socscimed.2008.02.027
∗Längst G, Seidling HM, Stützle M, Ose D, Baudendistel I, Szecsenyi J, Wensing M, Mahler C (2015) Factors associated with medication information in diabetes care: differences in perceptions between patients and health care professionals. Patient Prefer Adherence 15:1431–1441. https://doi.org/10.2147/PPA.S88357
Leong J, Walker S, Salek S (2015) A practical approach to communicating benefit-risk decisions of medicines to stakeholders. Front Pharmacol 6:99. https://doi.org/10.3389/fphar.2015.00099
Lipkus IM, Hollands JG (1999) The visual communication of risk. J Natl Cancer Inst Monogr 25:149–163. https://doi.org/10.1093/oxfordjournals.jncimonographs.a024191
Löwenstein GF, Weber EY, Hsee CK, Welch N (2001) Risk as feelings. Psychol Bull 127(2):267–286. https://doi.org/10.1037/0033-2909.127.2.267
∗Makoul G, Arntson P, Schofield T (1995) Health promotion in primary care: physician-patient communication and decision making about prescription medications. Soc Sci Med 41(9):1241–1254. https://doi.org/10.1016/0277-9536(95)00061-B
Malterud K (2001) Qualitative research: standards, challenges and guidelines. Lancet 358:483–488. https://doi.org/10.1016/S0140-6736(01)05627-6
Malterud K, Siersma VD, Goassora AD (2015) Sample size in qualitative interview studies: guided by information power. Qual Health Res 26(13):1753–1760. https://doi.org/10.1177/1049732315617444
Mayall S, Banerjee AK (2014) Therapeutic risk management of medicines. Woodhead (Elsevier), Cambridge
Mays N, Pope C (2000) Qualitative research in health care: assessing quality in qualitative research. BMJ 320:50–52. https://doi.org/10.1136/bmj.320.7226.50
Mazzaglia G, Straus SMJ, Arlett P, da Silva D, Janssen H, Raine J, Alteri E (2018) Study design and evaluation of risk minimization measures: a review of studies submitted to the European Medicines Agency for cardiovascular, endocrinology, and metabolic drugs. Drug Saf 41(2):191–202. https://doi.org/10.1007/s40264-017-0604-4
McColl E, Jacoby A, Thomas L, Scoutter J, Bamford C, Steen N, Thomas R, Harvey E, Garratt A, Bond J (2001) Design and use of questionnaires: a review of best practice applicable to surveys of health service staff and patients. Health Technol Assess 5:31
McComas KA (2006) Defining moments in risk communication research: 1996–2005. J Health Commun 11(1):75–91. https://doi.org/10.1080/10810730500461091
McDowell M (2009) Making sense of numbers about health risks: the Facts Box (Chapter 19). In: Elwyn G, Edwards A, Thompson R (eds) Shared decision making in health care: achieving evidence-based patient choice, 2nd edn. Oxford University Press, Oxford, pp 123–128
McFadden P, Taylor BJ, Campbell A, McQuilkin J (2012) Systematically identifying relevant research: case study on child protection social workers’ resilience. Res Soc Work Pract. 22:626–636. https://doi.org/10.1177/1049731512453209
McGinn AH, Taylor BJ, McColgan M, McQuilkin J (2016) Social work literature searching: current issues with databases and online search engines. Res Soc Work Pract 26(3):266–277. https://doi.org/10.1177/1049731514549423
Medical Research Council (2008) Developing and evaluating complex interventions. MRC, London. http://www.mrc.ac.uk/documents/pdf/complex-interventions-guidance/
Mevissen FDF, Ruiter RAC, Meertens RM, Zimbile F, Schaalma HP (2011) Justify your love: testing an online STI-risk communication intervention designed to promote condom use and STI-testing. Psychol Health 26:205–221. https://doi.org/10.1080/08870446.2011.531575
Montgomery P, Grant SP, Hopewell S, Macdonald G, Moher D, Michie S, Mayo-Wilson E (2013) Protocol for CONSORT-SPI: an extension for social and psychological interventions. Implement Sci 8(1):99. https://doi.org/10.1186/1748-5908-8-99
Mooney-Somers J, Olsen A (2017) Ethical review and qualitative research competence: guidance for reviewers and applicants. Res Ethics (3–4):128–138
Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O’Cathain A, Tinati T, Wight D, Baird J (2015a) Process evaluation of complex interventions: Medical Research Council guidance. BMJ 350:h1258. https://doi.org/10.1136/bmj.h1258
Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O’Cathain A, Tinati T, Wight D, Baird J (2015b) Process evaluation of complex interventions: a summary of Medical Research Council guidance. In: Richards DA, Hallberg IR (eds) Complex interventions in health: an overview of research methods. Routledge, Oxford, pp 222–231
Moorhead SA, Coates VE, Gallagher AM, Nolan G, Murphy K, Hazlett DE (2013a) Obesity communication among patients by health professionals: findings from the Weight Care Project. Health 5(8A3):100–109. https://doi.org/10.4236/health.2013.58A3015
Moorhead SA, Hazlett DE, Harrison L, Carroll JK, Irwin A, Hoving C (2013b) A new dimension of health care: systematic review of the uses, benefits, and limitations of social media for health communication. J Med Internet Res 15(4):e85. https://doi.org/10.2196/jmir.1933
Morse JM (2015) Data were saturated. Qual Health Res 25:587–588. https://doi.org/10.1177/1049732315576699
Nelson W, Reyna VF, Fagerlin A, Lipkus I, Peters E (2008) Clinical implications of numeracy: theory and practice. Ann Intern Med 35:261–274. https://doi.org/10.1007/s12160-008-9037-8
∗Newman PA, Seiden DS, Roberts KJ, Kakinami L, Duan N (2009) A small dose of HIV? HIV vaccine mental models and risk communication. Health Educ Behav 36(2):321–333. https://doi.org/10.1177/1090198107305078
O’Connor AM, Legare F, Stacey D (2003) Risk communication in practice: the contribution of decision aids. BMJ 327(7417):736–740. https://doi.org/10.1136/bmj.327.7417.736
∗Omedo M, Ogutu M, Awiti A, Musuva R, Muchiri G, Montgomery SP, Secor WE, Miwinzi P (2014) The effect of a health communication campaign on compliance with mass drug administration for schistosomiasis control in Western Kenya: The SCORE Project. Am J Trop Med Hyg 91(5):982. https://doi.org/10.4269/ajtmh.14-0136
Peters E (2008) Numeracy and the perception and communication of risk. Ann N Y Acad Sci 1128:1–7. https://doi.org/10.1196/annals.1399.001
Petticrew M (2011) When are complex interventions ‘complex’? When are simple interventions ‘simple’? Eur J Pub Health 21:397–398. https://doi.org/10.1093/eurpub/ckr084
Petticrew M, Roberts H (2003) Evidence, hierarchies, and typologies: horses for courses. J Epidemiol Community Health 57:527–529. https://doi.org/10.1136/jech.57.7.527
Petticrew M, Rehfuess E, Noyes J, Higgins JPT, Mayhew A, Pantoha T, Shemilt I, Sowden A (2013a) Synthesising evidence on complex interventions: how meta-analytic, qualitative and mixed-methods approaches can contribute. J Clin Epidemiol 66:1230–1243. https://doi.org/10.1016/j.jclinepi.2013.06.005
Petticrew M, Anderson L, Elder R, Grimshaw J, Hopkins D, Hahn R, Krause L, Kristjansson E, Mercer S, Sipe T, Tugwell P, Ueffing E, Waters E, Welch V (2013b) Complex interventions and their implications for systematic reviews: a pragmatic approach. J Clin Epidemiol 66:1209–1214. https://doi.org/10.1016/j.jclinepi.2013.06.004
Pluye P, Gagnon MP, Griffiths F, Johnson-Lafleur J (2009) A scoring system for appraising mixed methods research, and concomitantly appraising qualitative, quantitative and mixed methods primary studies in mixed studies reviews. Int J Nurs Stud 46(4):529–546. https://doi.org/10.1016/j.ijnurstu.2009.01.009
Presser S (ed) (2004) Methods for testing and evaluating survey questionnaires. Wiley, Hoboken
Price-Haywood EG, Roth KG, Shelby K, Cooper LA (2009) Cancer risk communication with low health literacy patients: a continuing medical education program. J Gen Intern Med 25(Suppl 2):126–129. https://doi.org/10.1007/s11606-009-1211-6
Raynor DK, de Veene P, Bryant D (2013) The effectiveness of the Summary of Product Characteristics (SmPC) and recommendations for improvement. Ther Innov Regul Sci 48:255–265. https://doi.org/10.1177/2168479013501311
∗Reber KC, Wieringa JE, Piening S, De Graeff PA,Haaijer-Ruskamp F, Mol PGM, Straus SMJM, Raine JM (2013) When direct health-care professional communications have an impact on inappropriate and unsafe use of medicines. Clin Pharmacol Ther 93(4):360–365. https://doi.org/10.1038/clpt.2012.262
Reeves S, Albert M, Kuper A, Hodges BD (2008) Qualitative research: why use theories in qualitative research? BMJ 337(7226):631–634. https://doi.org/10.1136/bmj.a949
Reyna VF, Adam MB (2003) Fuzzy-trace theory, risk communication and product labelling in sexually transmitted diseases. Risk Anal 23:325–342. https://doi.org/10.1111/1539-6924.00332
Reyna VF, Nelson WL, Han PK, Dieckmann NF (2009) How numeracy influences risk comprehension and medical decision making. Psychol Bull 135:943–973. https://doi.org/10.1037/a0017327
Ritchie J, Lewis J (2006) Qualitative research practice: a guide for social science students and researchers. Sage, London
Ryan R, Santesso N, Lowe D, Hill S, Grimshaw J, Prictor M, Kaufman C, Cowie G, Taylor M (2014) Interventions to improve safe and effective medicines use by consumers: an overview of systematic reviews. Cochrane Database Syst Rev 4:CD007768. https://doi.org/10.1002/14651858.CD007768.pub3
Sanchez-Menegay C, Stadler H (1994) Do physicians take into account patients’ expectations? J Gen Intern Med 9(7):404–406
Santiago-Delefosse M, Gavin A, Bruchez C, Roux P, Stephen SL (2016) Quality of qualitative research in the health sciences: analysis of the common criteria present in 58 assessment guidelines by expert users. Soc Sci Med 148:142–151. https://doi.org/10.1016/j.socscimed.2015.11.007
∗Schapira MM, Nattinger AB, McAuliffe TL (2006) The influence of graphic format on breast cancer risk communication. J Health Commun 11(6):569–582. https://doi.org/10.1080/10810730600829916
Schmid EF, Smith DA, Ryder SW (2007) Communicating the risks and benefits of medicines. Drug Discov Today 12:355–364. https://doi.org/10.1016/j.drudis.2007.03.003
Schüz N, Schüz B, Eid M (2013) When risk communication backfires: randomised controlled trial on self-affirmation and reactance to personalised risk feedback in high-risk individuals. Health Psychol 32:561–570. https://doi.org/10.1037/a0029887
Schwartz LM, Woloshin S, Welch HG (2009) Using a drug facts box to communicate drug benefits and harms. Ann Intern Med 150:516–527. https://doi.org/10.7326/0003-4819-150-8-200904210-00106
Smith MY, Morrato E (2014) Advancing the field of pharmaceutical risk minimization through application of implementation science best practices. Drug Saf 37(7):569–580. https://doi.org/10.1007/s40264-014-0197-0
Smith JA, Flowers P, Larkin M (2009) Interpretative phenomenological analysis: theory, method and research. Sage, London
Smith MY, Russell A, Bahri P, Mol PGM, Frise S, Freeman E, Morrato EH (2018) The RIMES statement: a checklist to assess the quality of studies evaluating risk minimization programs for medicinal products. Drug Saf 41:389–401. https://doi.org/10.1007/s40264-017-0619-x
Sobel R (2016) Evaluating the effectiveness of additional risk minimisation measures via surveys in Europe: challenges and recommendations. Bethesda, International Society for Pharmacoepidemiology
Spencer L, Ritchie J, Lewis J, Dillon L (2003) Quality in qualitative evaluation: a framework for assessing research evidence. Cabinet Office, London
Starks H, Trinidad SB (2007) Choose your method: a comparison of phenomenology, discourse analysis, and grounded theory. Qual Health Res 17:1372–1380. https://doi.org/10.1177/1049732307307031
Stevenson M, Taylor BJ (2016) Risk communication in dementia care: family perspectives. J Risk Res 21(6):692–709. https://doi.org/10.1080/13669877.2016.1235604
Stevenson M, Taylor BJ (2017) Risk communication in dementia care: professional perspectives on consequences, likelihood, words and numbers. Br J Soc Work 47(7):1940–1958. https://doi.org/10.1093/bjsw/bcw161
Stevenson M, Taylor BJ (2019 Feb) Involving individuals with dementia as co-researchers in analysis of findings from a qualitative study. Dementia (London) 18(2):701–712. https://doi.org/10.1177/1471301217690904
Stevenson M, Taylor BJ, Knox J (2016) Risk in dementia care: searching for the evidence. Health Risk Soc 18(1–2):4–20. https://doi.org/10.1080/13698575.2015.1119256
Stevenson M, McDowell ME, Taylor BJ (2018) Concepts for communication about risk in dementia care: a review of the literature. Dementia (London) 17(3):359–390. https://doi.org/10.1177/1471301216647542
Stevenson M, Savage B, Taylor BJ (2019) Perception and communication of risk in decision making by persons with a dementia. Dementia (London) 18:1108–1127. https://doi.org/10.1177/1471301217704119
Taylor BJ (2006a) Risk management paradigms in health and social services for professional decision making on the long-term care of older people. Br J Soc Work. 36:1411–1429. https://doi.org/10.1093/bjsw/bch406
Taylor BJ (2006b) Factorial surveys: using vignettes to study professional judgement. Br J Soc Work 36:1187–1207. https://doi.org/10.1093/bjsw/bch345
Taylor BJ (2012a) Developing an integrated assessment tool for the health and social care of older people. Br J Soc Work 42:1293–1314. https://doi.org/10.1093/bjsw/bcr133
Taylor BJ (2012b) Intervention research (Chapter 27). In: Gray M, Midgley J, Webb S (eds) Social work handbook. Sage, New York, pp 424–439
Taylor BJ (2012c) Models for professional judgement in social work. Eur J Soc Work 15:546–562. https://doi.org/10.1080/13691457.2012.702310
Taylor BJ (2017a) Decision making, assessment and risk in social work, 3rd edn. Sage, London
Taylor BJ (2017b) Heuristics in professional judgement: a psycho-social rationality model. Br J Soc Work 47(4):1043–1060. https://doi.org/10.1093/bjsw/bcw084
Taylor BJ, Campbell B (2011) Quality, risk and governance: social workers’ perspectives. Int J Leadership Public Services 7:256–272. https://doi.org/10.1108/17479881111194152
Taylor BJ, Donnelly M (2006a) Professional perspectives on decision making about the long-term care of older people. Br J Soc Work 36:807–826. https://doi.org/10.1093/bjsw/bch322
Taylor BJ, Donnelly M (2006b) Risks to home care workers: professional perspectives. Health Risk Soc 8:239–256. https://doi.org/10.1080/13698570600871695
Taylor BJ, McKeown C (2013) Assessing and managing risk with people with physical disabilities: development of a safety checklist. Health Risk Soc 15:162–175. https://doi.org/10.1080/13698575.2013.764973
Taylor BJ, Zeller RA (2007) Getting robust and valid data on decision policies: the factorial survey. Irish J Psychol 28(1–2):27–42. https://doi.org/10.1080/03033910.2007.10446246
Taylor BJ, Dempster M, Donnelly M (2003) Hidden gems: systematically searching electronic databases for research publications for social work and social care. Br J Soc Work 33:423–439. https://doi.org/10.1093/bjsw/33.4.423
Taylor BJ, Dempster M, Donnelly M (2007) Grading gems: appraising the quality of research for social work and social care. Br J Soc Work 37:335–354. https://doi.org/10.1093/bjsw/bch361
Taylor BJ, Killick C, O’Brien M, Begley E, Carter-Anand J (2014) Older people’s conceptualisation of elder abuse and neglect. J Elder Abuse Negl 26(3):223–243. https://doi.org/10.1080/08946566.2013.795881
Taylor BJ, Killick C, McGlade A (2015) Understanding and using research in social work. Sage, London
Taylor BJ, Killick C, Bertotti T, Enosh G, Gautschi J, Hietamäki J, Sicora A, Whittaker A (2017) European Social Work Research Association SIG to study decisions, assessment and risk. J Evid Inf Soc Work 15(1):82–94. https://doi.org/10.1080/23761407.2017.1394244
Taylor BJ, Stevenson M, McDowell M (2018) Communicating risk in dementia care: survey of health and social care professionals. Health Soc Care Community 26(2):e291–e303. https://doi.org/10.1111/hsc.12519
Teigen KH, Brun W (1999) The directionality of verbal probability expressions: effects on decisions, predictions and probabilistic reasoning. Organ Behav Hum Decis Process 80:155–190. https://doi.org/10.1006/obhd.1999.2857
Thomson R, Edwards A, Grey J (2005) Risk communication in the clinical consultation. Clin Med 5:465–469
∗Tong V, Raynor DK, Blalock SJ, Aslani P (2015) Consumer interpretation of ramipril and clopidogrel medication risk information: implications for risk communication strategies. Patient Prefer Adherence 9:983–988. https://doi.org/10.2147/PPA.S86414
Trevena LJ, Zikmund-Fisher BJ, Edwards A, Gaissmaier W, Galesic M, Han PKJ, King J, Lawson ML, Linder SK, Lipkus I, Ozanne E, Peters E, Timmermans D, Woloshin S (2013) Presenting quantitative information about decision outcomes: a risk communication primer for patient decision aid developers. BMC Med Inform Decis Mak 13(Suppl 2):S7. https://doi.org/10.1186/1472-6947-13-S2-S7
Vik P (2014) Regression, ANOVA and the general linear model: a statistics primer. Sage, Thousand Oaks
Visschers VH, Meertens RM, Passchier WW, De Vries NN (2009) Probability information in risk communication: a review of the research literature. Risk Anal 29:267–287. https://doi.org/10.1111/j.1539-6924.2008.01137.x
von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP, STROBE Initiative (2008) The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol 61(4):344–349. https://doi.org/10.1371/journal.pmed.0040297
Waters EA, Weinstein ND, Colditz GA, Emmons K (2006) Formats for improving risk communication in medical tradeoff decisions. J Health Commun 11:167–182. https://doi.org/10.1080/10810730500526695
Wegwarth O, Gaissmaier W, Gigerenzer G (2011) Deceiving numbers: survival rates and their impact on doctors’ risk communication. Med Decis Mak 31(3):386–394. https://doi.org/10.1177/0272989X10391469
West SL, Squiers LB, Mccormack L, Southwell BG, Brouwer ES, Ashok M, Lux L, Boudewyns V, O’Donoghue A, Sullivan HW (2013) Communicating quantitative risks and benefits in promotional prescription drug labeling or print advertising. Pharmacoepidemiol Drug Saf 22:447–458. https://doi.org/10.1002/pds.3416
Witry MJ, Doucette WR (2015) Factors influencing community pharmacists’ likelihood to ask medication monitoring questions: a factorial survey. Res Soc Adm Pharm 11:639–650. https://doi.org/10.1016/j.sapharm.2014.11.007
∗Young SD, Oppenheimer DM (2006) Different methods of presenting risk information and their influence on medication compliance intentions: results of three studies. Clin Ther 28:129–139. https://doi.org/10.1016/j.clinthera.2006.01.013
∗Young S, Oppenheimer DM (2009) Effect of communication strategy on personal risk perception and treatment adherence intentions. Psychol Health Med 14(4):430–442. https://doi.org/10.1080/13548500902890103
Zipkin DMA, Umscheid CA, Keating NL, Allen E, Aung K, Beyth R, Kaatz S, Mann DM, Sussman JB, Korenstein D, Schardt C, Nagi A, Sloane R, Feldstein DA (2014) Evidence-based risk communication: a systematic review. Ann Intern Med 161:270–280. https://doi.org/10.7326/M14-0295
Zolnierek KB, Dimatteo MR (2009) Physician communication and patient adherence to treatment: a meta-analysis. Med Care 47:826–834. https://doi.org/10.1097/MLR.0b013e31819a5acc
Acknowledgements
The authors would like to acknowledge the support of Mrs. Joanne Knox and Miss Janice McQuilkin, Assistant Subject Librarians; Dr. Patricia Carlisle, Associate Lecturer; and Miss Mabel Stevenson, Research Assistant, all of Ulster University, Northern Ireland, who assisted with the literature review that underpins this chapter.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2020 Springer Nature Singapore Pte Ltd.
About this chapter
Cite this chapter
Taylor, B.J., Moorhead, S.A. (2020). The Social Sciences. In: Bahri, P. (eds) Communicating about Risks and Safe Use of Medicines. Adis, Singapore. https://doi.org/10.1007/978-981-15-3013-5_8
Download citation
DOI: https://doi.org/10.1007/978-981-15-3013-5_8
Published:
Publisher Name: Adis, Singapore
Print ISBN: 978-981-15-3012-8
Online ISBN: 978-981-15-3013-5
eBook Packages: MedicineMedicine (R0)