Obtaining informed consent from people with aphasia - ACNR

ACNRMJ11:Layout 1 27/4/11 22:09 Page 30REHABILITATION ARTICLEOne Size Does NotFit All: Obtaining informedconsent from people with aphasiaDr Rebecca Palmer,PhD, BA,Research fellow, Speech andLanguage Therapist, University ofSheffield/Sheffield TeachingHospitals (SY CLAHRC). Rebecca’sclinical and research interests arein the assessment and treatmentof aphasia and dysarthria, use ofcomputer technology for selfmanaged rehabilitation ofcommunication disorders and theinclusion of people with aphasiain research.Gail Paterson, BSc,Research Speech and LanguageTherapist, Sheffield PCT (SYCLAHRC). Gail is a member of aresearch project team usingcomputer treatment software forpeople with all severities ofaphasia. She also works as aspeech and language therapist inthe field of adult learningdisability in Worksop.Correspondence to:Email: r.l.palmer@sheffield.ac.ukAcknowledgement:This paper presents independentresearch commissioned by theNational Institute for HealthResearch (NIHR) under itsResearch for Patient Benefit (RfPB)Programme (Grant ReferenceNumber PB-PG-1207-14097). Theviews expressed are those of theauthors and not necessarily thoseof the NHS, the NIHR or theDepartment of Health.Obtaining informed consent is difficultwhen an individual has a communicationdisability, presenting challenges wheninvolving patients in decisions about their medicaltreatment, giving power of attorney, participation inresearch and in discharge planning. There is agrowing awareness that people with aphasia cangive informed consent if information is providedin an accessible format. However, the range oflanguage disability that can be experiencedmakes it unlikely that one approach will facilitateunderstanding of all people with aphasia. In anNIHR Research for Patient Benefit (RfPB) fundedproject, the authors are piloting a procedure todifferentiate methods of making informationaccessible according to aphasia severity.Respect for the right of individuals to be fullyinvolved in decisions about their healthcare is laidout in The NHS Constitution (2010). 1 One of thekey principles is that “NHS services must reflect theneeds and preferences of patients, their familiesand their carers.” In addition it commits to making“decisions in a clear and transparent way, so thatpatients and the public can understand how servicesare planned and delivered”. These rights arealso reflected in The World Medical AssociationDeclaration of Helsinki which sets out the ethicalprinciples that guide medical research. 2Health professionals are aware that a patientmust have decision-making capacity as a prerequisitefor providing informed consent. 3 TheMental Capacity Act (2005) details the abilitiesthat demonstrate capacity to make an informeddecision: a) to understand the information relevantto the decision; b) to retain that information;c) to use or weigh that information as part of theprocess of making the decision; and d) to communicatethe decision (whether by talking, using signlanguage or by any other means). 4 For people withaphasia, difficulty in communicating a decisionverbally or though writing is clear to most professionalswho are trying to establish their wishes.More important (but often less obvious) is the factthat the person with aphasia may not have understoodthe written information or a verbal explanationof the issues to be considered. The MentalCapacity Act states that people should be giventhe opportunity to make their own decisions as faras possible stating that “A person is not to beregarded as unable to understand the informationrelevant to a decision if he is able to understandan explanation of it given to him in a way that isappropriate to his circumstances (using simplelanguage, visual aids or any other means)”. 4The Connect communication disability networkhas contributed greatly to the inclusion of peoplewith aphasia in decision making by providingadvice on how to produce information that isaccessible to people with compromised languageskills. 5 They advocate ideas for making writteninformation easier to understand such as use ofshort sentences with key words emboldened,pictures to illustrate key ideas and space betweeneach concept.Such accessible formats are being used by agrowing number of health professionals andresearchers. 6-8 However, it is important to emphasisethat whilst protecting an individual’s right tomake autonomous decisions by providing informationin a more accessible format using the standardconventions recommended by Connectabove, some individuals with aphasia will still notpossess the level of language ability required tounderstand the information in this format. Forexample, if they are unable to read at all, highlightingkey written words will not help informthem. Therefore the authors propose that byacknowledging the existence of a communicationdisorder and applying a standard set of conventionsfor making information accessible, wecannot assume that we have adequately informedthe specific individual we are interacting with. Inorder to provide information in a way that isconsistent with the individual’s level of language, itis necessary to be familiar with the profile andseverity of their abilities. Although a full assessmentof language is a complex process andrequires skilled speech and language therapists,communication screening tests for other healthprofessionals have been validated, for example theFrenchay Aphasia Screening Test 9 and the SheffieldScreening Test for Acquired Language Disorders. 10These screening tests indicate the presence andseverity of aphasia and so give an indication of theperson’s communication ability. The procedurebeing piloted in the RfPB funded project tailorsthe information giving process to the needs of theindividual as follows:The amount of spoken and written informationthe individual understands is established througha screening test. Expressive difficulties are determinedalong with strategies that help the individualto express themselves effectively. Provisionof information is then matched to the level oflanguage ability in the following way:1. If written paragraphs are fully understood awritten information sheet is provided using layterminology with key ideas highlighted. (Ifwritten paragraphs are understood but it istime consuming or effortful for the individual,they are given the option of reading informationusing the standard aphasia friendlyconventions)2. Where the individual understands at least three30 > ACNR > VOLUME 11 NUMBER 2 > MAY/JUNE 2011

ACNRMJ11:Layout 1 27/4/11 22:09 Page 31REHABILITATION ARTICLEkey words in a written sentence, e.g. ‘Pointto the floor, the ceiling and the window’.Information is provided using the fullrange of standard aphasia friendly conventionsadvocated by Connect: removingjargon and acronyms and using straightforward language; keeping one main ideaper sentence; using active not passivesentences; using bullet points rather thanblocks of text; using a question and answerformat; using a plain, clear font in size 14pt; use of plenty of white space; use of relevantand respectful pictures or diagrams tohelp get the message across and providingsummaries of key points.3. Where the aphasia limits the individual tounderstanding only two key written orspoken words in a sentence, e.g. ‘touchyour head and your knee’, the standardaphasia friendly format may be difficult tointerpret without additional support. Forthese individuals a ‘total communicationapproach’ is used whereby each key ideais presented on a separate powerpointslide using key written words and illustrationsor animations. The visual presentationof the information is also supportedby spoken explanations, drawing andgesture.4. Where aphasia is more severe and lessthan two key written or spoken words areunderstood, the authors suggest that it willbe difficult to be sure that we have fullyinformed the individual of importantconcepts such as their right to withdrawwithout affecting future treatment, orconcepts that are outside of the immediateenvironment such as implications ofdischarge choices. In this case simplepictures and key words, or a short videoclip are used to inform the individualabout the key topic area and to establishtheir general feelings about it. Fullyinformed consent is then sought from arelative or carer who is given the completeinformation.These different methods of providing informationwere approved by the Bradford ethicscommittee in advance of piloting them in theRfPB funded study.Part of the consent process involves theindividual asking questions to ensure fullunderstanding of what is going to happen.When the ability to speak is compromisedasking questions is difficult. The procedurebeing piloted encourages the individual todescribe a situation if they can’t find the rightwords, or to use gesture, point to pictures ordraw. If their speech is difficult to understand,asking them to slow down or write key wordscan help. Stein et al recommend a process offacilitated consent whereby a person whoknows the individual’s history, values and preferencesasks questions that the individualwould ask if he/she could do this easily. 3Decision making capacity as defined bythe Mental Capacity Act is specific to a particulardecision being made at a specific time.Once information has been presented in aformat that is most consistent with the individual’sability to understand written andspoken language, strategies can be used toensure that the specific information has beenunderstood before taking consent. Theseinclude presenting forced alternatives, e.g. ‘Arewe going to give you a tablet or a questionnaire?’,‘If you want to stop, do you have tocarry on, yes or no?’. For participants whohave reduced understanding of spokenlanguage, pictures can be provided to sortaccording to their relevance to the informationgiven. Additionally, pictures can be givenfor the participant to sequence the order inwhich events will happen.Where individuals with severe aphasia donot demonstrate understanding of the decisionsto be made, or of their implications, theMental Capacity Act states that a decisionshould be made in the individual’s bestinterest and that the decision should be theleast restrictive of their basic rights and freedoms.4 People involved in caring for the individualwho lacks capacity should beconsulted and where there are no familymembers or close friends, an independentmental capacity advocate (IMCA) can beappointed to speak on the patient’s behalf.In summary, this article proposes ways ofpresenting information consistent withdifferent severities of aphasia, strategies forchecking information has been understoodand ways to identify those who are unlikely tobe able to provide informed consent. lREFERENCES1. Department of Health. The NHS Constitution. UK:Crown; 2010.2. World Medical Organisation. Declaration of Helsinki(1964). BMJ 1996;313(7070):1448-9.3. Stein J, Brady Wagner LC. Is informed consent a ‘yes orno’ response? Enhancing the shared decision-makingprocess for persons with aphasia. Top StrokeRehabilitation 2006;13(4):42-6.4. Department of Health. The Mental Capacity Act. UK:Crown; 2005.5. Connect. Including people with communication disabilityin stroke research and consultation: A guide forresearchers and service providers. Connect communicationdisability network;2007.6. Kagan A, Kimelman MDZ. Informed consent in aphasiaresearch: Myth or Reality? Clin Aphasiology1995;23:65-75.7. Brennan AD, Worrall AE, McKenna KT. The relationshipbetween specific features of aphasia-friendly written materialand comprehension of written material for peoplewith aphasia: An exploratory study. Aphasiology2005;19(8):693-711.8. Dalemans R, Wade DT, van den Heuvel WJA, de WitteLP. Facilitating the participation of people with aphasia inresearch: a description of strategies. Clin Rehabilitation2009;23(10):948-59.9. Enderby P, Wood V, Wade J. Frenchay Aphasia ScreeningTest. Second edition. Oxford;Wiley:2006.10. Syder D, Body R, Parker M, Boddy M. Sheffield ScreeningTest for Acquired Language Disorders. Windsor;NFER-Nelson:1993.Organised byandParkinson’s 2011:recent advances in clinical management21st June 2011 LondonEpilepsy in Children23rd June 2011 LondonStroke 2011:strategies for treatment and rehabilitation7th July 2011 Londonin association withTo book your place: +44(0)20 7501 6762 conferences@markallengroup.com www.mahealthcareevents.co.ukACNR > VOLUME 11 NUMBER 2 > MAY/JUNE 2011 > 31