Edited by: Gianfranco Spalletta, Santa Lucia Foundation (IRCCS), Italy
Reviewed by: Ole Weis Bjerrum, Odense University Hospital, Denmark; Frederik Haarig, Rudolf Virchow Glauchau Clinic, Germany
This article was submitted to Aging Psychiatry, a section of the journal Frontiers in Psychiatry
This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
The right to make autonomous decisions is enshrined in law. However, the question how persons with cognitive deficits can be enabled to make autonomous decisions has not been satisfactorily addressed. In particular, the concept of supported decision-making and its implementation into practice has been poorly explored for persons with dementia (PwD).This article describes the empirical development and implementation of support tools to enhance informed consent processes (so called enhanced consent procedures/ECP) for PwD on whether to undergo lumbar puncture. In the end of the process of pilot testing and further development of the tools, the following tools were defined: (1) Standardized Interview Structure, (2) Elaborated Plain Language, (3) Ambience and Room Design, (4) Keyword Lists, (5) Priority Cards, (6) Visualization, and (7) Simplified Written Informed Consent (Patient Information), as well as the general attitude (8) Person-Centered Attitude of the facilitator. As the development, implementation and evaluation of ECP tools is one objective of the transnational ENSURE project, we also include an overview of future empirical procedures. So far, our findings can serve as a selection of possibilities to support PwD in decision-making and help practitioners achieve an appropriate balance between the autonomy and protection of PwD in complex decision-making situation. Future studies should address the question if the proposed set of tools is effective to enhance informed consent processes in PwD.
Individual autonomy encompasses self-determined decision-making in medical and research contexts. The UN Convention on the Rights of Persons with Disabilities (UN-CRPD) is a human rights treaty that recognizes persons with disabilities, such as persons with dementia (PwD), as persons before the law with legal capacity and obliges state parties to support their ability to make decisions with legal effect (
The British
In order to make treatment and research decisions, PwD need to participate in an informed consent (IC) process, which requires that: (1) a competent person (2) makes a free choice (3) following adequate information disclosure (
The “combined SDM model” (
The assessment of whether a person is competent is based on a concept of mental capacity that implies cognitive functioning. Grisso and Applebaum (
Beyond ethico-legal requirements, the highly internalized IC process is characterized by different attributes, such as the transfer of a huge amount of information (
Further research is needed on how to implement SDM in PwD, how to enhance IC processes for PwD in treatment and research decisions, and how to provide adequate decision-support.
This study is part of the broad transnational ENSURE project (Enhancing the Informed Consent Process: Supported decision-making and capacity assessment in clinical dementia research). The development, implementation, and evaluation of tools to enhance the IC process for PwD is one of the transnational project partner's four objectives.
First steps toward achieving this objective are to identify appropriate support measures and to examine their potential for transfer to different decision-making situations. We choose the decision for lumbar puncture because (1) lumbar puncture constitutes a medical procedure whose IC process is precisely defined, (2) it is an important part of diagnostic work-up in certain cases (
Based on five defined criteria, those more general support measures were selected from the systematic literature review (
The defined tools and their application instructions were piloted and further developed in two processes. On the one hand, the first drafts of tools were implemented in real clinical IC procedures for a lumbar puncture from January 2018 and optimized together with the applying physician. Therefore, ethical approval was obtained from the local ethics committee of the University Hospital Frankfurt. On the other hand, the further development included an iterative process involving discussions among the members of the Ensure Consortium (ethicists, legal experts, nursing scientists, physicians, psychologists). This process was used to revise content and structure of the tools and to reflect upon ethical and practical challenges until consensus regarding appropriateness was reached. Issues like overburdening, overcompensation, sidestepping memory, interpersonal leverage, oversimplification, issue framing, and criteria for allocation of the support were discussed within the consortium.
Together with our practice partners we recruited persons with suspected dementia that had been admitted to a psychogeriatric ward because of subjectively experienced cognitive impairment. Lumbar punctures had been recommended to the patients by their physicians for diagnostic work-up. Thus, we introduced the newly developed tools in an IC process that would have occurred anyway. In few cases the LP war performed immediately after the ECT, usually within 1 to 2 days after it.
Fourteen persons with suspected dementia participated in the ECPs, 11 of whom had been diagnosed with dementia or mild cognitive impairment (MCI) at the time of discharge from hospital. One ECP had to be terminated due to strong emotional stress of the participant. Of the 14 ECP conducted, 10 people with dementia or MCI (7 women, 3 men) could be finally included in the study. The participants were on average 67.5 years old (range 54–78). Two of them were diagnosed with Alzheimer's at the time of hospital discharge, four with unspecified dementia, and four with MCI. The participant's mean Mini Mental State Examination (MMSE) score was 24.3 (range 21–27).
The physician who was in charge of the lumbar puncture was trained to use the tools, and the entire ECP was carried out on a hypothetical case. One researcher (TW) attended all ECPs and assisted the physician with the implementation of the tools. A thirteen-page moderation-plan was written for conducting the ECPs.
Following the first implementation, we successively adjusted and optimized the applied tools regarding their feasibility. The attending researcher (TW) discussed each conducted ECP with the physician. They reviewed observations made during the ECP and jointly identified optimization potential. Subsequently the research team refined the tools again. The adjustments made are displayed in
Adjustments to applied support tools.
Person-centered attitude | •The person-centered attitude of the facilitator was initially handled as an independent tool before it was decided to define it as a basic attitude that must be practiced as a basis for the application of other tools |
•After telling the patient about a suspected diagnosis of dementia, we took a break. We emphasized that dementia was |
|
Standardized interview structure | •We included standardized breaks after each information sequence |
•If a participant wanted something repeated, we instructed the physician to repeat the whole information sequence (Mac-CAT) | |
•We instructed the physician to assist in reproducing information if necessary, e.g., by naming keywords from the required responses (Mac-CAT) | |
•We added missing information | |
Elaborated Plain language | •Sentences and wording were continually simplified, e.g. |
“We can use the needle to withdraw a few milliliters of spinal fluid.” | |
“We can take a little spinal fluid |
|
Ambience and room design | •We chose another room in preference to the doctor's room (room for occupational therapy) |
•Before participants were brought in, we prepared the room (tidiness, fresh air, heating) | |
Keyword lists | •We divided up the keywords and employed one list for each of the three information sequences |
•The keyword lists were taken back after each check of understanding so that participants had a maximum of one list in front of them | |
Priority cards | •We instructed the physician to ask our participants to explain the significance of only the “important” cards, rather than all of them |
Visualization | •We changed the pictogram |
The spine was drawn more realistically and transparently | |
Person on the picture was depicted as more ageless | |
Enhanced written Consent form (patient) information | •Modified according to the new pictogram |
In the end of the process of pilot testing and further development of the tool, the following tools were defined: (1) Standardized Interview Structure, (2) Elaborated Plain Language, (3) Ambience and Room Design, (4) Keyword Lists, (5) Priority Cards, (6) Visualization, and (7) Simplified Written Informed Consent (Patient Information), as well as the general attitude (8) Person-Centered Attitude of the facilitator. Instructions for use have been formulated for each tool.
Current research into decision-making needs and demands of PwD shows that the facilitator's attitude should be person-centered (
- Invite participants, welcome them using their names.
- Introduce yourself with first, last name and function, if not yet known.
- Offer participants a chair and something to drink.
- Take a seat yourself.
- Establish and maintain eye contact.
- Provide time for questions, allow breaks if necessary.
- Clarify that you are available to take further questions after the ECP; say goodbye.
Prior to implementation, advice and recommendations were discussed with the physician.
When obtaining IC, a structured approach and an open interview-style appeared crucial. To structure the IC process and reduce its complexity, information could therefore be presented in shorter segments (
To provide a supportive structure, we decided to use the MacArthur Competence Tool (MacCAT-T) to obtain IC and assess competency to consent to treatment. The Mac-CAT interview is performed in a standardized way by providing fixed sequences of information and then asking questions, inter alia, to verify understanding (
To explain the IC procedure and clarify the structure of the ECP for the physician, we designed a detailed plan of the IC procedure (written schedule) in accordance with the MacCAT-T. It included an exemplary script and the timely application of further tools.
The consideration of language aspects (
(1) We focused on the reduction of syntactical complexity, which means shortening sentences and using fewer subordinate clauses. We used only one subordinate clause per main clause and avoided convoluted sentences.
(2) We introduced semantic elaborations, which refer to the provision of further information (expansions) and an iteration of keywords by allowing them to “move” from sentence to sentence: “
(3) We limited the vocabulary, which means we avoided technical terms, e.g., “image of the brain” rather than “CT scan.”
(4) We focused on neutral prosody that includes the avoidance of a slow speaking rate, high pitch, and short sentences (
In order to facilitate decision-making and clarify choices (
To avoid sidetracking stimuli, we chose a separate room for the IC process in preference to the doctor's office. The room, which is usually used for occupational therapy, has no telephone connection or computer access, and is located at the end of the corridor of the ward. We asked the physician to leave her phones outside during the IC process and told other health care practitioners on the ward not to disturb us for the next 30 min. In addition we placed a “please do not disturb” sign on the door and closed it. Apart from the patient (and sometimes a relative), only two persons attended the process (researcher, physician). The selected room has a large window providing natural light. The table the attending persons were sitting at was kept tidy.
While Smebye et al.(
To achieve this, we applied additional lists with bulleted key information. We summarized the most important information by using easy-to-read language, and wrote the key points on a number of lists, each containing a manageable amount of information. The keyword lists were provided in addition to verbal information, thus utilizing iteration by presenting information repeatedly (spoken and written).
We instructed the physician to hand over each list after the information had been provided verbally, ask the PwD to summarize what he or she had been told, and then to take the list away before starting the next information sequence.
To help PwD draw conclusions, compare the influence of lumbar puncture with its alternatives, and gauge its risks and benefits with respect to their situation and everyday life, we developed so-called priority cards. The communication framework Talking Mats, which aims to facilitate communication in the decision-making process (
Priority Cards enable PwD to visualize the risks and benefits of treatment on a single card containing a visual scale (important, not important). We asked PwD to use the scale to organize each card in accordance with their priorities. Furthermore, they had the option to express their own views on the treatment. During the ECP, the attending researcher wrote such reasons down on a blank card. After organizing the cards, we asked our participants to explain why the “important” cards were significant to them, and what effects the risks and benefits would have, regardless of whether they provide their consent.
Featherstonehaugh et al. (
We developed a pictogram to help PwD understand the treatment, and more specifically, the puncture site of the needle and the posture during treatment (see
Illustrating pictogram of the diagnostic procedure used for the enhanced consent procedure.
Directing the attention of PwD to important aspects (
We prepared our own enhanced written consent form (patient information) in preference to the hospital's to allow more time to decide (
We wanted to give PwD the opportunity to read received verbal information again (iteration) and to permit them to review their preliminary decisions, thus facilitating ongoing consent. Re-reading the information in a more relaxed atmosphere, possibly with a trusted person, may trigger further questions, which could then be clarified in another discussion with the physician. Signing the consent form was mostly postponed until later.
Written patient information was kept short (two pages) and delivered information in the same sequence as the verbal presentation. It includes visualization, hence the developed pictogram (see Tool 6). We simplified the enhanced written consent form information by using elaborated plain language
This article describes the systematic development of support-tools for an ECP for lumbar puncture treatment for PwD. By involving an interdisciplinary transnational expert group, ethical, legal, and practical concerns were all considered equally. Our practical experience increased during each ECP, e.g., how to elicit the opinions of PwD, how often to offer breaks, how manageable the number of keywords on a single keyword list is, and how to apply elaborated plain language.
First observations of the researcher who assisted the implementation process (TW) support the assumption that many tools could simplify the IC or at least did not cause negative effects on the participants. For example, the visualization
The next steps of our project included an empirical evaluation of the tools within a small sample of PwD which is described elsewhere (
In this step the tools were not yet been evaluated in terms of their effectiveness (e.g., improved understanding, appreciation, reasoning, or overall score of mental capacity) but rather in terms of their feasibility, acceptability and appropriateness for the affected PwD. This evaluation was based on problem-centered interviews with every ECP participant. An additional small study was conducted, to investigate dementia researchers view on the developed tools (
We recognize that every PwD must be considered and treated as an individual with his or her own views, needs, abilities, and impairments. Therefore, we do not recommend applying all eight tools in standard form, but rather suggest selecting tools according to the individual needs of the single PwD and the resources (e.g., time and room availability) and abilities (e.g., qualifications) of the practitioner. Our findings can serve as a selection of possibilities to support PwD in decision-making and help practitioners achieve an appropriate balance between the autonomy and protection of PwD in complex decision-making.
Future studies should address the question if the proposed set of tools is not only feasible but also effective to enhance informed consent processes in PwD.
The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.
The studies involving human participants were reviewed and approved by Ethikkommission des Fachbereichs Medizin der Goethe Universität Frankfurt, Deutschland. The patients/participants provided their written informed consent to participate in this study.
The ENSURE Consortium was a transnational project team of interdisciplinary researchers: Goethe-Universität Frankfurt (Julia Haberstroh, Frank Oswald, Johannes Pantel, Theresa Wied), Ruhr-Universität Bochum (Jakov Gather, Matthé Scholten, Jochen Vollmann), Universidade da Coruña (Nathalia Álvarez Lata, José-Antonio Seoane), Universidade Católica Portuguesa (Ana Sofia Carvalho, Pablo Hernández Marrero).
TW and JH: substantial contributions to the conception and design of the work. TW, JH, JP, JG, MS, JV, and FO: substantial contribution to the analysis or interpretation of data for the work. TW and TK: substantial contribution to the acquisition of data. TW, JP, and JH: drafting the work or revising it critically for important intellectual content. TW, JH, JG, JQ, TK, FO, MQ, MS, JV, and JP: provide approval for publication of the content and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All authors contributed to the article and approved the submitted version.
This work was funded by the Network of European Funding for Neuroscience Research (ERA-NET NEURON), the German Federal Ministry of Education and Research (Grant No. 01GP1623A), and the Volkswagen Foundation.
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
The authors would like to thank Phillip Elliott for proofreading the document.
1We are ready to share the latest version of the written patient information and other relevant material with interested researchers and clinicians upon request.