Assessing the longevity of attribute framing in attenuating the nocebo effect to brand and generic medication.
attribute framing
expectations
generic medication
nocebo effect
placebo effect
positive framing
Journal
Applied psychology. Health and well-being
ISSN: 1758-0854
Titre abrégé: Appl Psychol Health Well Being
Pays: England
ID NLM: 101502957
Informations de publication
Date de publication:
05 Jul 2024
05 Jul 2024
Historique:
received:
13
03
2024
accepted:
17
06
2024
medline:
5
7
2024
pubmed:
5
7
2024
entrez:
5
7
2024
Statut:
aheadofprint
Résumé
The perception of taking a generic, relative to brand, medication has been demonstrated to exacerbate the nocebo effect. Conversely, positive attribute framing has been shown to attenuate the nocebo effect. However, little is known about the longevity of positive attribute framing nor how it interacts with generic versus brand treatment cues. Healthy participants (N = 205) were randomised to receive either sham-modafinil capsules with a brand or generic appearance, in conjunction with standard negative side effect framing (brand-negative: N = 42; generic-negative: N = 41) or positive side effect framing (brand-positive: N = 40; generic-positive: N = 40). The remainder were randomised to a no-treatment control (N = 42). Participants were informed that modafinil could enhance alertness and cognitive performance and reduce fatigue. Critically, modafinil was described as having several potential side effects. Treatment-related side effects, alertness, fatigue and cognitive performance were measured at baseline, 30-min post-treatment and 24 h later. Nocebo and placebo effects were observed across modafinil-treated participants relative to control. Positive framing significantly reduced warned side effects for 24 h. Perceived side effect likelihood, severity, and worry mediated the nocebo, but not framing, effect. Results have important implications for the presentation of side effect information, providing a potential route to reduce unwanted negative effects of generic medication.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : Australian Research Council Discovery Project Award
ID : DP220102231
Informations de copyright
© 2024 The Author(s). Applied Psychology: Health and Well‐Being published by John Wiley & Sons Ltd on behalf of International Association of Applied Psychology.
Références
Australian Government Theraputic Goods Administration. (2022). APO‐MODAFINIL modafinil 100 mg tablet blister pack (395230): Consumer medicine information. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2023-CMI-01697-1
Barnes, K., & Colagiuri, B. (2022). Positive attribute framing increases COVID‐19 booster vaccine intention for unfamiliar vaccines. Vaccines, 10(6), 962.
Barnes, K., Faasse, K., & Colagiuri, B. (2023). The impact of side effect framing on COVID‐19 booster vaccine intentions in an Australian sample. Vaccine, 41(12), 2046–2054. https://doi.org/10.1016/j.vaccine.2023.02.023
Barnes, K., Faasse, K., Geers, A. L., Helfer, S. G., Sharpe, L., Colloca, L., & Colagiuri, B. (2019). Can positive framing reduce nocebo side effects? current evidence and recommendation for future research [mini review]. Frontiers in Pharmacology, 10, 167. https://doi.org/10.3389/fphar.2019.00167
Barnes, K., Nicholls, K., Orlievsky, S., Pei, C., Elder, C., & Faasse, K. (2024). A novel paradigm examining the remote induction of nocebo effects online. Health Psychology, 43(3), 225–236. https://doi.org/10.1037/hea0001334
Barnes, K., Wang, R., & Faasse, K. (2023). Practitioner warmth and empathy attenuates the nocebo effect and enhances the placebo effect. Applied Psychology: Health and Well‐Being, 16(2), 421–441. https://doi.org/10.1111/aphw.12497
Benedetti, F., Lanotte, M., Lopiano, L., & Colloca, L. (2007). When words are painful: Unraveling the mechanisms of the nocebo effect. Neuroscience, 147(2), 260–271. https://doi.org/10.1016/j.neuroscience.2007.02.020
Bigman, C. A., Cappella, J. N., & Hornik, R. C. (2010). Effective or ineffective: Attribute framing and the human papillomavirus (HPV) vaccine. Patient Education and Counseling, 81, S70–S76. https://doi.org/10.1016/j.pec.2010.08.014
Blokland, A. (2023). Can placebo or nocebo pills improve or impair cognition performance? Human Psychopharmacology: Clinical and Experimental, 38(3), e2869. https://doi.org/10.1002/hup.2869
Brennan, T. A., & Lee, T. H. (2004). Allergic to Generics. Annals of Internal Medicine, 141(2), 126–130. https://doi.org/10.7326/0003-4819-141-2-200407200-00011
Buchanan, E. M. (2018). MeMoBootR: A package for mediation, moderation, and bootstrapped indirect effects. R package version 0.0.0.6001.
Caplandies, F. C., Colagiuri, B., Helfer, S. G., & Geers, A. L. (2017). Effect type but not attribute framing alters nocebo headaches in an experimental paradigm. Psychology of Consciousness: Theory, Research, and Practice, 4(3), 259–273. https://doi.org/10.1037/cns0000130
Cho, H. (2015). The malleable effect of name fluency on pharmaceutical drug perception. Journal of Health Psychology, 20(10), 1369–1374. https://doi.org/10.1177/1359105314525486
Colagiuri, B., & Boakes, R. A. (2010). Perceived treatment, feedback, and placebo effects in double‐blind RCTs: an experimental analysis. Psychopharmacology, 208(3), 433–441. https://doi.org/10.1007/s00213-009-1743-9
Colagiuri, B., Livesey, E. J., & Harris, J. A. (2011). Can expectancies produce placebo effects for implicit learning? Psychonomic Bulletin & Review, 18(2), 399–405. https://doi.org/10.3758/s13423-010-0041-1
Colagiuri, B., Park, J., Barnes, K., Sharpe, L., Boakes, R. A., Colloca, L., & Livesey, E. J. (2021). Pre‐exposure, but not overshadowing, inhibits nocebo hyperalgesia. The Journal of Pain, 22(7), 864–877. https://doi.org/10.1016/j.jpain.2021.02.008
Colgan, S., Faasse, K., Martin, L. R., Stephens, M. H., Grey, A., & Petrie, K. J. (2015). Perceptions of generic medication in the general population, doctors and pharmacists: a systematic review. BMJ Open, 5(12), e008915. https://doi.org/10.1136/bmjopen-2015-008915
Colgan, S. L. E., Faasse, K., Pereira, J. A., Grey, A., & Petrie, K. J. (2016). Changing perceptions and efficacy of generic medicines: An intervention study. Health Psychology, 35(11), 1246–1253. https://doi.org/10.1037/hea0000402
Colloca, L., & Miller, F. G. (2011). The nocebo effect and its relevance for clinical practice. Psychosomatic Medicine, 73(7), 598–603. https://doi.org/10.1097/PSY.0b013e3182294a50
Corsi, N., & Colloca, L. (2017). Placebo and nocebo effects: The advantage of measuring expectations and psychological factors [original research]. Frontiers in Psychology, 8, 308. https://doi.org/10.3389/fpsyg.2017.00308
Curran, S. L., Andrykowski, M. A., & Studts, J. L. (1995). Short Form of the Profile of Mood States (POMS‐SF): Psychometric information. Psychological Assessment, 7(1), 80–83. https://doi.org/10.1037/1040-3590.7.1.80
Davit, B. M., Nwakama, P. E., Buehler, G. J., Conner, D. P., Haidar, S. H., Patel, D. T., Yang, Y., Yu, L. X., & Woodcock, J. (2009). Comparing generic and innovator drugs: A review of 12 years of bioequivalence data from the United States Food and Drug Administration. Annals of Pharmacotherapy, 43(10), 1583–1597. https://doi.org/10.1345/aph.1M141
Devlin, E. J., Whitford, H. S., & Denson, L. A. (2019). The impact of valence framing on response expectancies of side effects and subsequent experiences: a randomised controlled trial. Psychology & Health, 34(11), 1358–1377. https://doi.org/10.1080/08870446.2019.1609677
Dohle, S., & Siegrist, M. (2013). Fluency of pharmaceutical drug names predicts perceived hazardousness, assumed side effects and willingness to buy. Journal of Health Psychology, 19(10), 1241–1249. https://doi.org/10.1177/1359105313488974
Donovan, R. J., & Jalleh, G. (2000). Positive versus negative framing of a hypothetical infant immunization: The influence of involvement. Health Education & Behavior, 27(1), 82–95. https://doi.org/10.1177/109019810002700108
Dunne, S., Shannon, B., Dunne, C., & Cullen, W. (2013). A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacology and Toxicology, 14(1), 1. https://doi.org/10.1186/2050-6511-14-1
Dunne, S., Shannon, B., Hannigan, A., Dunne, C., & Cullen, W. (2014). Physician and pharmacist perceptions of generic medicines: What they think and how they differ. Health Policy, 116(2), 214–223. https://doi.org/10.1016/j.healthpol.2014.03.007
Dunne, S. S., & Dunne, C. P. (2015). What do people really think of generic medicines? A systematic review and critical appraisal of literature on stakeholder perceptions of generic drugs. BMC Medicine, 13(1), 173. https://doi.org/10.1186/s12916-015-0415-3
Elliot, C., Murray, D., & Pearson, L. (1983). British abilities scales. NFER‐Nelson.
Espay, A. J., Norris, M. M., Eliassen, J. C., Dwivedi, A., Smith, M. S., Banks, C., Allendorfer, J. B., Lang, A. E., Fleck, D. E., Linke, M. J., & Szaflarski, J. P. (2015). Placebo effect of medication cost in Parkinson disease. Neurology, 84(8), 794–802. https://doi.org/10.1212/WNL.0000000000001282
Faasse, K., Cundy, T., Gamble, G., & Petrie, K. J. (2013). The effect of an apparent change to a branded or generic medication on drug effectiveness and side effects. Psychosomatic Medicine, 75(1), 90–96. https://doi.org/10.1097/PSY.0b013e3182738826
Faasse, K., Cundy, T., & Petrie, K. J. (2009). Thyroxine: Anatomy of a health scare. BMJ, 339, b5613. https://doi.org/10.1136/bmj.b5613
Faasse, K., Grey, A., Jordan, R., Garland, S., & Petrie, K. J. (2015). Seeing is believing: Impact of social modeling on placebo and nocebo responding. Health Psychology, 34(8), 880–885. https://doi.org/10.1037/hea0000199
Faasse, K., Huynh, A., Pearson, S., Geers, A. L., Helfer, S. G., & Colagiuri, B. (2019). The influence of side effect information framing on nocebo effects. Annals of Behavioral Medicine, 53(7), 621–629. https://doi.org/10.1093/abm/kay071
Faasse, K., Keevers, Y., de Groot, A., Nicholls, K., Helfer, S. G., & Geers, A. L. (2023). Choice and the nocebo effect: If a little is good, more is better? Journal of Psychosomatic Research, 164, 111083. https://doi.org/10.1016/j.jpsychores.2022.111083
Faasse, K., & Martin, L. R. (2018). Chapter Fifteen—The power of labeling in nocebo effects. In L. Colloca (Ed.), International review of neurobiology (Vol. 139) (pp. 379–406). Academic Press. https://doi.org/10.1016/bs.irn.2018.07.016
Faasse, K., Martin, L. R., Grey, A., Gamble, G., & Petrie, K. J. (2016). Impact of brand or generic labeling on medication effectiveness and side effects. Health Psychology, 35(2), 187–190. https://doi.org/10.1037/hea0000282
Foroughi, C. K., Monfort, S. S., Paczynski, M., McKnight, P. E., & Greenwood, P. M. (2016). Placebo effects in cognitive training. Proceedings of the National Academy of Sciences, 113(27), 7470–7474. https://doi.org/10.1073/pnas.1601243113
Freling, T. H., Vincent, L. H., & Henard, D. H. (2014). When not to accentuate the positive: Re‐examining valence effects in attribute framing. Organizational Behavior and Human Decision Processes, 124(2), 95–109. https://doi.org/10.1016/j.obhdp.2013.12.007
Geers, A. L., Faasse, K., Guevarra, D. A., Clemens, K. S., Helfer, S. G., & Colagiuri, B. (2021). Affect and emotions in placebo and nocebo effects: What do we know so far? Social and Personality Psychology Compass, 15(1), e12575. https://doi.org/10.1111/spc3.12575
Goldszmidt, R. B., Buttendorf, A. R., Schuldt Filho, G., Souza, J. M. Jr., & Bianchini, M. A. (2019). The impact of generic labels on the consumption of and adherence to medication: A randomized controlled trial. European Journal of Public Health, 29(1), 12–17. https://doi.org/10.1093/eurpub/cky183
Greene, J. A. (2016). Generic: The unbranding of modern medicine. Johns Hopkins University Press. https://doi.org/10.1353/book.72111
Greene, J. A., & Kesselheim, A. S. (2011). Why do the same drugs look different? Pills, trade dress, and public health. The New England Journal of Medicine, 365(1), 83–89. https://doi.org/10.1056/NEJMhle1101722
Haydarov, R., & Gordon, J. C. (2015). Effect of combining attribute and goal framing within messages to change vaccination behavior. Journal of Communication in Healthcare, 8(1), 45–54. https://doi.org/10.1179/1753807615Y.0000000005
Heikkilä, R., Mäntyselkä, P., & Ahonen, R. (2011). Do people regard cheaper medicines effective? Population survey on public opinion of generic substitution in Finland. Pharmacoepidemiology and Drug Safety, 20(2), 185–191. https://doi.org/10.1002/pds.2084
Helfer, S. G., Colagiuri, B., Faasse, K., Clemens, K. S., Caplandies, F., & Geers, A. L. (2022). The influence of message framing on nocebo headaches: Findings from a randomized laboratory design. Journal of Behavioral Medicine, 45(3), 438–450. https://doi.org/10.1007/s10865-022-00294-6
Isaac, M. S., & Poor, M. (2016). The sleeper framing effect: The influence of frame valence on immediate and retrospective judgments. Journal of Consumer Psychology, 26(1), 53–65. https://doi.org/10.1016/j.jcps.2015.05.002
Kesselheim, A. S., Misono, A. S., Lee, J. L., Stedman, M. R., Brookhart, M. A., Choudhry, N. K., & Shrank, W. H. (2008). Clinical equivalence of generic and brand‐name drugs used in cardiovascular disease: A systematic review and meta‐analysis. JAMA, 300(21), 2514–2526. https://doi.org/10.1001/jama.2008.758
Kessels, R. P. C., van Zandvoort, M. J. E., Postma, A., Kappelle, L. J., & de Haan, E. H. F. (2000). The Corsi Block‐Tapping Task: Standardization and normative data. Applied Neuropsychology, 7(4), 252–258. https://doi.org/10.1207/S15324826AN0704_8
Kirchner, W. K. (1958). Age differences in short‐term retention of rapidly changing information. Journal of Experimental Psychology, 55(4), 352–358. https://doi.org/10.1037/h0043688
Kleinstäuber, M., Colgan, S., & Petrie, K. J. (2021). Changing understanding, perceptions, pain relief of and preference for generic medicines with patient education: An experimental intervention study. Research in Social and Administrative Pharmacy, 17(7), 1288–1299. https://doi.org/10.1016/j.sapharm.2020.09.014
Kleinstäuber, M., MacKrill, K., & Petrie, K. J. (2018). Characteristics of individuals who prefer branded innovator over generic medicines: a New Zealand general population survey. Drugs & Therapy Perspectives, 34(10), 478–483. https://doi.org/10.1007/s40267-018-0541-z
Krishnamurthy, P., Carter, P., & Blair, E. (2001). Attribute framing and goal framing effects in health decisions. Organizational Behavior and Human Decision Processes, 85(2), 382–399. https://doi.org/10.1006/obhd.2001.2962
Lee, Y.‐S., Jung, W.‐M., Bingel, U., & Chae, Y. (2020). The context of values in pain control: Understanding the price effect in placebo analgesia. The Journal of Pain, 21(7), 781–789. https://doi.org/10.1016/j.jpain.2019.11.005
Lenth, R. V. (2023). emmeans: Estimated marginal means, aka least‐squares means.
Levin, I. P., Schneider, S. L., & Gaeth, G. J. (1998). All frames are not created equal: A typology and critical analysis of framing effects. Organizational Behavior and Human Decision Processes, 76(2), 149–188. https://doi.org/10.1006/obhd.1998.2804
Looby, A., & Earleywine, M. (2011). Expectation to receive methylphenidate enhances subjective arousal but not cognitive performance. Experimental and Clinical Psychopharmacology, 19(6), 433–444. https://doi.org/10.1037/a0025252
MacKrill, K., Gamble, G. D., Bean, D. J., Cundy, T., & Petrie, K. J. (2019). Evidence of a media‐induced nocebo response following a nationwide antidepressant drug switch. Clinical Psychology in Europe, 1(1), 1–12. https://doi.org/10.32872/cpe.v1i1.29642
MacKrill, K., Kleinstäuber, M., & Petrie, K. J. (2019). The effect of rebranding generic medicines on drug efficacy and side effects. Psychology & Health, 34(12), 1470–1485. https://doi.org/10.1080/08870446.2019.1616088
Mao, A., Barnes, K., Sharpe, L., Geers, A. L., Helfer, S. G., Faasse, K., & Colagiuri, B. (2021). Using positive attribute framing to attenuate nocebo side effects: A cybersickness study. Annals of Behavioral Medicine, 55(8), 769–778. https://doi.org/10.1093/abm/kaaa115
McNeil, B. J., Pauker, S. G., Sox, H. C., & Tversky, A. (1982). On the elicitation of preferences for alternative therapies. New England Journal of Medicine, 306(21), 1259–1262. https://doi.org/10.1056/NEJM198205273062103
Michnevich, T., Pan, Y., Hendi, A., Oechsle, K., Stein, A., & Nestoriuc, Y. (2022). Preventing adverse events of chemotherapy for gastrointestinal cancer by educating patients about the nocebo effect: a randomized‐controlled trial. BMC Cancer, 22(1), 1008. https://doi.org/10.1186/s12885-022-10089-2
Nyhan, B., & Reifler, J. (2015). Does correcting myths about the flu vaccine work? An experimental evaluation of the effects of corrective information. Vaccine, 33(3), 459–464. https://doi.org/10.1016/j.vaccine.2014.11.017
O'Connor, A. M., Pennie, R. A., & Dales, R. E. (1996). Framing effects on expectations, decisions, and side effects experienced: The case of influenza immunization. Journal of Clinical Epidemiology, 49(11), 1271–1276. https://doi.org/10.1016/S0895-4356(96)00177-1
Oken, B. S., Flegal, K., Zajdel, D., Kishiyama, S., Haas, M., & Peters, D. (2008). Expectancy effect: Impact of pill administration on cognitive performance in healthy seniors. Journal of Clinical and Experimental Neuropsychology, 30(1), 7–17. https://doi.org/10.1080/13803390701775428
Pan, Y., Kinitz, T., Stapic, M., & Nestoriuc, Y. (2019). Minimizing drug adverse events by informing about the nocebo effect—an experimental study [original research]. Frontiers in Psychiatry, 10, 504. https://doi.org/10.3389/fpsyt.2019.00504
Quinn, V. F., Livesey, E. J., & Colagiuri, B. (2017). Latent inhibition reduces nocebo nausea, even without deception. Annals of Behavioral Medicine, 51(3), 432–441. https://doi.org/10.1007/s12160-016-9867-8
R Core Team. (2023). R: A language and environment for statistical computing. R Foundation for Statistical Computing.
Raynor, D. K., Silcock, J., Knapp, P., & Edmondson, H. (2007). How do patients use medicine information leaflets in the UK? International Journal of Pharmacy Practice, 15(3), 209–218. https://doi.org/10.1211/ijpp.15.3.0008
Rief, W., Barsky, A. J., Glombiewski, J. A., Nestoriuc, Y., Glaesmer, H., & Braehler, E. (2011). Assessing general side effects in clinical trials: reference data from the general population. Pharmacoepidemiology and Drug Safety, 20(4), 405–415. https://doi.org/10.1002/pds.2067
Ringe, J. D., & Möller, G. (2009). Differences in persistence, safety and efficacy of generic and original branded once weekly bisphosphonates in patients with postmenopausal osteoporosis: 1‐year results of a retrospective patient chart review analysis. Rheumatology International, 30(2), 213–221. https://doi.org/10.1007/s00296-009-0940-5
Rooney, T., Sharpe, L., Todd, J., Tang, B., & Colagiuri, B. (2024). The nocebo effect across health outcomes: A systematic review and meta‐analysis. Health Psychology, 43(1), 41–57. https://doi.org/10.1037/hea0001326
Saadi, A., Mahmood, A., Sweeney, J., & Webster, R. K. (2023). What is the benefit of adding placebo side‐effect information to positively framed patient leaflets? An online trial. European Journal of Health Psychology, 30(3), 103–114. https://doi.org/10.1027/2512-8442/a000125
Schwarz, K. A., & Büchel, C. (2015). Cognition and the placebo effect—Dissociating subjective perception and actual performance. PLoS ONE, 10(7), e0130492. https://doi.org/10.1371/journal.pone.0130492
Sedjo, R. L., & Cox, E. R. (2009). The influence of targeted education on medication persistence and generic substitution among consumer‐directed health care enrollees. Health Services Research, 44(6), 2079–2092. https://doi.org/10.1111/j.1475-6773.2009.01023.x
Slovic, P., Finucane, M. L., Peters, E., & MacGregor, D. G. (2013). Risk as analysis and risk as feelings: Some thoughts about affect, reason, risk and rationality. In The feeling of risk (pp. 21–36). Routledge. https://doi.org/10.4324/9781849776677
Steinman, M. A., Chren, M.‐M., & Landefeld, C. S. (2007). What's in a name? Use of brand versus generic drug names in united states outpatient practice. Journal of General Internal Medicine, 22(5), 645–648. https://doi.org/10.1007/s11606-006-0074-3
Stoet, G. (2017). PsyToolkit: A novel web‐based method for running online questionnaires and reaction‐time experiments. Teaching of Psychology, 44(1), 24–31. https://doi.org/10.1177/0098628316677643
Turner, D. C., Robbins, T. W., Clark, L., Aron, A. R., Dowson, J., & Sahakian, B. J. (2003). Cognitive enhancing effects of modafinil in healthy volunteers. Psychopharmacology, 165(3), 260–269. https://doi.org/10.1007/s00213-002-1250-8
Vallès, J.‐A., Barreiro, M., Cereza, G., Ferro, J.‐J., Martı́nez, M. J., Escribà, J.‐M., Iglesias, B., Cucurull, E., & Barceló, E. (2003). A prospective multicenter study of the effect of patient education on acceptability of generic prescribing in general practice. Health Policy, 65(3), 269–275. https://doi.org/10.1016/S0168-8510(03)00018-6
Waber, R. L., Shiv, B., Carmon, Z., & Ariely, D. (2008). Commercial features of placebo and therapeutic efficacy. JAMA: Journal of the American Medical Association, 299(9), 1016–1017. https://doi.org/10.1001/jama.299.9.1016
Wager, T. D., & Atlas, L. Y. (2015). The neuroscience of placebo effects: Connecting context, learning and health. Nature Reviews Neuroscience, 16(7), 403–418. https://doi.org/10.1038/nrn3976
Webster, R. K., & Rubin, G. J. (2020). The effect of positively framing side‐effect risk in two different formats on side‐effect expectations, informed consent and credibility: A randomised trial of 16‐ to 75‐year‐olds in England. Drug Safety, 43(10), 1011–1022. https://doi.org/10.1007/s40264-020-00959-8
Webster, R. K., Weinman, J., & Rubin, G. J. (2018). Positively framed risk information in patient information leaflets reduces side effect reporting: A double‐blind randomized controlled trial. Annals of Behavioral Medicine, 52(11), 920–929. https://doi.org/10.1093/abm/kax064
Winkler, A., & Hermann, C. (2019). Placebo‐ and nocebo‐effects in cognitive neuroenhancement: When expectation shapes perception [original research]. Frontiers in Psychiatry, 10, 498. https://doi.org/10.3389/fpsyt.2019.00498