Development, piloting, and evaluation of an evidence-based informed consent form for total knee arthroplasty (EvAb-Pilot): a protocol for a mixed methods study

Alina Weise, Julia Lühnen, Stefanie Bühn, Felicia Steffen, Sandro Zacher, Julia Lauberger, Deha Murat Ates, Andreas Böhmer, Henning Rosenau, Anke Steckelberg, Tim Mathes, Alina Weise, Julia Lühnen, Stefanie Bühn, Felicia Steffen, Sandro Zacher, Julia Lauberger, Deha Murat Ates, Andreas Böhmer, Henning Rosenau, Anke Steckelberg, Tim Mathes

Abstract

Background: Practitioners frequently use informed consent forms to support the physician-patient communication and the informed consent process. Informed consent for surgery often focuses on risk centered information due to high liability risks for treatment errors. This may affect patients' anxiety of adverse events and the nocebo effect. This study focuses on the optimization of pre-surgical information on risks and complications, and at the same time reconciles these information with legal requirements.

Methods: The development, piloting, and evaluation of evidence-based informed consent forms for total knee arthroplasty (TKA) and related anesthesia procedures will follow the UK MRC Framework for developing and evaluating complex interventions. Conducting different sub-studies, we will (I) qualitatively explore the information acquisition and decision-making processes, (II) develop and pilot test evidence-based informed consent forms on the example of TKA and related anesthesia procedures, (III) conduct a monocentric interrupted time series (ITS) pilot study to evaluate the effects of evidence-based informed consent forms in comparison with standard consent forms, and (IV) perform a process evaluation to identify barriers and facilitators to the implementation of the intervention and to analyze mechanisms of impact.

Discussion: The evidence-based and understandable presentation of risks in informed consent forms aims at avoiding distorted risk depiction and strengthening the patients' competencies to correctly assess the risks of undergoing surgery. This might reduce negative expectations and anxiety of adverse events, which in turn might reduce the nocebo effect. At the same time, the practitioners' acceptance of evidence-based informed consent forms meeting legal requirements could be increased.

Trial registration: ClinicalTrials.gov, NCT04669483 . Registered 15 December 2020. German Clinical Trials Registry, DRKS00022571 . Registered 15 December 2020.

Keywords: Anxiety; Evidence-based health information; Informed consent; Informed consent form; Mixed methods; Nocebo effect; Pilot; Risk communication; Total knee arthroplasty (TKA).

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Logic model
Fig. 2
Fig. 2
Sub-studies in accordance with the UK MRC Framework

References

    1. McCormack DJ, Gulati A, Mangwani J. Informed consent: a global perspective. Bone Joint J. 2018;100-b(6):687–692. doi: 10.1302/0301-620X.100B6.BJJ-2017-1542.R1.
    1. Aagaard L, Kristensen K. Off-label and unlicensed prescribing in Europe: implications for patients’ informed consent and liability. Int J Clin Pharm. 2018;40(3):509–512. doi: 10.1007/s11096-018-0646-4.
    1. Hanson M, Pitt D. Informed consent for surgery: risk discussion and documentation. Canadian J Surg. 2017;60(1):69–70. doi: 10.1503/cjs.004816.
    1. Skiba R, Sikotra N, Wilson A, Clay TD, Gabbay E. DOCTORS UNDERSTANDING OF CONSENT LAW. Intern Med J. 2020. 10.1111/imj.14873. Epub ahead of print. PMID: 32358854.
    1. Parzeller M, Wenk M, Zedler B, Rothschild M. Aufklärung und Einwilligung bei ärztlichen Eingriffen. Dtsch Arztebl Int. 2007;104(9):576.
    1. James JT, Eakins DJ, Scully RR. Informed consent, shared-decision making and a reasonable patient's wishes based on a cross-sectional, national survey in the USA using a hypothetical scenario. BMJ Open. 2019;9(7):e028957. doi: 10.1136/bmjopen-2019-028957.
    1. Todd NV, Birch NC. Informed consent in spinal surgery. Bone Joint J. 2019;101-b(4):355–360. doi: 10.1302/0301-620X.101B4.BJJ-2018-1045.R2.
    1. Faasse K, Helfer SG, Barnes K, Colagiuri B, Geers AL. Experimental Assessment of Nocebo Effects and Nocebo Side Effects: Definitions, Study Design, and Implications for Psychiatry and Beyond. Front Psychiatry. 2019;10:396. 10.3389/fpsyt.2019.00396. PMID: 31258492; PMCID: PMC6587910.
    1. Colagiuri B, McGuinness K, Boakes RA, Butow PN. Warning about side effects can increase their occurrence: an experimental model using placebo treatment for sleep difficulty. J Psychopharm. 2012;26(12):1540–1547. doi: 10.1177/0269881112458730.
    1. Prediger B, Meyer E, Büchter R, Mathes T. Nocebo effects of a simplified package leaflet compared to unstandardised oral information and a standard package leaflet: a pilot randomised controlled trial. Trials. 2019;20(1):458. doi: 10.1186/s13063-019-3565-3.
    1. Faasse K, Huynh A, Pearson S, Geers AL, Helfer SG, Colagiuri B. The Influence of Side Effect Information Framing on Nocebo Effects. Ann Behav Med. 2019;53(7):621-9. 10.1093/abm/kay071. PMID: 30204841.
    1. Bhattacharyya T, Yeon H, Harris MB. The medical-legal aspects of informed consent in orthopaedic surgery. J Bone Joint Surg Am. 2005;87(11):2395–2400. doi: 10.2106/JBJS.D.02877.
    1. Lühnen J, Mühlhauser I, Steckelberg A. Qualität von Aufklärungsbögen. Dtsch Arztebl Int. 2018;115(22):377–383.
    1. Schröder HG, R. Nocebo-Effekte: Plädoyer für eine wohlgeformte Kommunikation 2018. Available from: Accessed 12-09-2020
    1. Hansen E, Zech N, Meissner K. Placebo und Nocebo: Wie einsetzen bzw. vermeiden? Der Internist. 2017;58(10):1102–1110. doi: 10.1007/s00108-017-0294-0.
    1. Webster RK, Weinman J, Rubin GJ. A systematic review of factors that contribute to nocebo effects. Health Psychol. 2016;35(12):1334–1355. doi: 10.1037/hea0000416.
    1. Peters ML, Sommer M, de Rijke JM, Kessels F, Heineman E, Patijn J, Marcus MAE, Vlaeyen JWS, van Kleef M. Somatic and psychologic predictors of long-term unfavorable outcome after surgical intervention. Ann Surg. 2007;245(3):487–494. doi: 10.1097/01.sla.0000245495.79781.65.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013;50(5):587–592. doi: 10.1016/j.ijnurstu.2012.09.010.
    1. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WSM, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Mayring P, Fenzl T. Qualitative Inhaltsanalyse. In: Baur N, Blasius J, editors. Handbuch Methoden der empirischen Sozialforschung. Wiesbaden: Springer Fachmedien Wiesbaden; 2014. pp. 543–556.
    1. Charvet-Berard AI, Chopard P, Perneger TV. Measuring quality of patient information documents with an expanded EQIP scale. Patient Educ Couns. 2008;70(3):407–411. doi: 10.1016/j.pec.2007.11.018.
    1. Webster RK, Rubin GJ. Influencing Side-Effects to Medicinal Treatments: A Systematic Review of Brief Psychological Interventions. Front Psychiatry. 2019;9:775. . PMID: 30804822; PMCID: PMC6371736.
    1. Evers AWM, Colloca L, Blease C, Annoni M, Atlas LY, Benedetti F, Bingel U, Büchel C, Carvalho C, Colagiuri B, Crum AJ, Enck P, Gaab J, Geers AL, Howick J, Jensen KB, Kirsch I, Meissner K, Napadow V, Peerdeman KJ, Raz A, Rief W, Vase L, Wager TD, Wampold BE, Weimer K, Wiech K, Kaptchuk TJ, Klinger R, Kelley JM. Implications of placebo and nocebo effects for clinical practice: expert consensus. Psychother Psychosom. 2018;87(4):204–210. doi: 10.1159/000490354.
    1. Ancker JS, Senathirajah Y, Kukafka R, Starren JB. Design features of graphs in health risk communication: a systematic review. J Am Med Informatics Assoc. 2006;13(6):608–618. doi: 10.1197/jamia.M2115.
    1. Trevena LJ, Barratt A, Butow P, Caldwell P. A systematic review on communicating with patients about evidence. J Eval Clin Pract. 2006;12(1):13–23. doi: 10.1111/j.1365-2753.2005.00596.x.
    1. O'Connor AM, Pennie RA, Dales RE. Framing effects on expectations, decisions, and side effects experienced: The case of influenza immunization. J Clin Epidemiol. 1996;49(11):1271–1276. doi: 10.1016/S0895-4356(96)00177-1.
    1. Lühnen J AM, Mühlhauser I, Steckelberg A. Leitlinie evidenzbasierte Gesundheitsinformation Hamburg. 2017. Available from: Accessed 12-09-2020
    1. Büchter RB, Fechtelpeter D, Knelangen M, Ehrlich M, Waltering A. Words or numbers? Communicating risk of adverse effects in written consumer health information: a systematic review and meta-analysis. BMC Med Inform Decis Mak. 2014;14(1):76. doi: 10.1186/1472-6947-14-76.
    1. Berry DC, Knapp P, Raynor DK. Provision of information about drug side-effects to patients. Lancet. 2002;359(9309):853–854. doi: 10.1016/S0140-6736(02)07923-0.
    1. Guyatt G, Oxman AD, Akl EA, Kunz R, Vist G, Brozek J, Norris S, Falck-Ytter Y, Glasziou P, deBeer H. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol. 2011;64(4):383–394. doi: 10.1016/j.jclinepi.2010.04.026.
    1. Kinnersley P, Phillips K, Savage K, Kelly MJ, Farrell E, Morgan B, Whistance R, Lewis V, Mann MK, Stephens BL, Blazeby J, Elwyn G, Edwards AG. Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. Cochrane Database Syst Rev. 2013;(7):CD009445. 10.1002/14651858.CD009445.pub2. PMID: 23832767.
    1. Glaser J, Nouri S, Fernandez A, Sudore RL, Schillinger D, Klein-Fedyshin M, Schenker Y. Interventions to improve patient comprehension in informed consent for medical and surgical procedures: an updated systematic review. Med Decis Making. 2020;40(2):119–143. doi: 10.1177/0272989X19896348.
    1. Berger-Hoger B, Liethmann K, Muhlhauser I, Haastert B, Steckelberg A. Nurse-led coaching of shared decision-making for women with ductal carcinoma in situ in breast care centers: A cluster randomized controlled trial. Int J Nurs Stud. 2019;93:141–152. doi: 10.1016/j.ijnurstu.2019.01.013.
    1. Steckelberg A, Haastert B, Hülfenhaus C, Mühlhauser I. Effect of evidence-based risk information on “informed choice” in colorectal cancer screening: randomised controlled trial. Gesundheitswesen. 2015;77(Suppl 1):S93–S94.
    1. Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. Med J BMJ. 2015;350(may08 1):h2147. doi: 10.1136/bmj.h2147.
    1. Bernal JL, Cummins S, Gasparrini A. Interrupted time series regression for the evaluation of public health interventions: a tutorial. Int J Epidemiol. 2017;46(1):348–355. doi: 10.1093/ije/dyw098.
    1. Hinneburg J, Hecht L, Berger-Höger B, Buhse S, Lühnen J, Steckelberg A. Development and piloting of a blended learning training programme for physicians and medical students to enhance their competences in evidence-based decision-making. ZEFQ. 2020;150:104–111.
    1. Hornblow AR, Kidson MA. The visual analogue scale for anxiety: a validation study. Aust N Z J Psychiatry. 1976;10(4):339–341. doi: 10.3109/00048677609159523.
    1. Labaste F, Ferré F, Combelles H, Rey V, Foissac JC, Senechal A, Conil JM, Minville V. Validation of a visual analogue scale for the evaluation of the postoperative anxiety: A prospective observational study. Nurs Open. 2019;6(4):1323–1330. doi: 10.1002/nop2.330.
    1. Theunissen M, Peters ML, Schouten EGW, Fiddelers AAA, Willemsen MGA, Pinto PR, Gramke HF, Marcus MAE. Validation of the Surgical Fear Questionnaire in Adult Patients Waiting for Elective Surgery. PLOS ONE. 2014;9(6):e100225. doi: 10.1371/journal.pone.0100225.
    1. Voutilainen A, Pitkäaho T, Kvist T, Vehviläinen-Julkunen K. How to ask about patient satisfaction? The visual analogue scale is less vulnerable to confounding factors and ceiling effect than a symmetric Likert scale. J Adv Nurs. 2016;72(4):946–957. doi: 10.1111/jan.12875.
    1. de Boer AG, van Lanschot JJ, Stalmeier PF, van Sandick JW, Hulscher JB, de Haes JC, et al. Is a single-item visual analogue scale as valid, reliable and responsive as multi-item scales in measuring quality of life? Qual Life Res. 2004;13(2):311–320. doi: 10.1023/B:QURE.0000018499.64574.1f.
    1. Dawson J, Fitzpatrick R, Murray D, Carr A. Questionnaire on the perceptions of patients about total knee replacement. J Bone Surg. 1998;80(1):63–69. doi: 10.1302/0301-620X.80B1.0800063.
    1. Viechtbauer W, Smits L, Kotz D, Bude L, Spigt M, Serroyen J, et al. A simple formula for the calculation of sample size in pilot studies. J Clin Epidemiol. 2015;68(11):1375–1379. doi: 10.1016/j.jclinepi.2015.04.014.
    1. Lenzner T, Hadler P, Neuert C, Klingler M, Wolf M, Sarafoglou A. Demographische Standards. 2018.
    1. Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, et al. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019;95:103208. doi: 10.1016/j.jbi.2019.103208.
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–381. doi: 10.1016/j.jbi.2008.08.010.
    1. Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials – a practical guide with flowcharts. BMC Med Res Methodol. 2017;17(1):162. doi: 10.1186/s12874-017-0442-1.
    1. Turner SL, Karahalios A, Forbes AB, Taljaard M, Grimshaw JM, Korevaar E, Cheng AC, Bero L, McKenzie JE. Creating effective interrupted time series graphs: Review and recommendations. Res Synth Methods. 2021;12(1):106-17. 10.1002/jrsm.1435. Epub 2020 Jul 22. PMID: 32657532; PMCID: PMC7818488.
    1. SAS Institute . The SAS system for Windows. Cary: SAS Inst; 2013.
    1. R Core Team. R: A Language and Environment for Statistical Computing. Vienna: R Foundation for Statistical Computing.
    1. Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. Med J BMJ. 2015;350(mar19 6):h1258. doi: 10.1136/bmj.h1258.
    1. Miller WL, Crabtree BF, Nutting PA, Stange KC, Jaen CR. Primary care practice development: a relationship-centered approach. Ann Fam Med. 2010;8(Suppl 1):S68–S79. doi: 10.1370/afm.1089.
    1. Hower KI, Pfaff H, Kowalski C, Wensing M, Ansmann L. Measuring change attitudes in health care organizations. J Health Organ Manag. 2019;33(3):266–285. doi: 10.1108/JHOM-06-2018-0177.
    1. Arnold SV, Decker C, Ahmad H, Olabiyi O, Mundluru S, Reid KJ, Soto GE, Gansert S, Spertus JA. Converting the informed consent from a perfunctory process to an evidence-based foundation for patient decision making. Circ Cardiovasc Qual Outcomes. 2008;1(1):21–28. doi: 10.1161/CIRCOUTCOMES.108.791863.
    1. Gillies MA, Baldwin FJ. Do patient information booklets increase perioperative anxiety? Eur J Anaesthesiol. 2001;18(9):620–622. doi: 10.1097/00003643-200109000-00010.
    1. Blalock SJ, Sage A, Bitonti M, Patel P, Dickinson R, Knapp P. Communicating information concerning potential medication harms and benefits: What gist do numbers convey? Patient Educ Couns. 2016;99(12):1964–1970. doi: 10.1016/j.pec.2016.07.022.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe