Understanding the risks and benefits of healthcare decisions
Evidence review E
NICE Guideline, No. 204
Authors
National Guideline Alliance (UK).Understanding the risks and benefits of healthcare decisions
Review question
What are the best ways to help children and young people and the parents and carers of babies and young children understand the risks and benefits of healthcare decisions?
Introduction
In order to be involved in decisions about their care, children and young people, and the parents and carers of babies and young children, need to be provided with information about the risks and benefits of different options so that they can weigh up the choices. Promoting an understanding of the potential effectiveness or side-effects of any intervention is an essential component of shared decision-making, and this in turn has the potential to make young people feel more involved and empowered, more in control and better prepared for treatment, improve motivation and engagement with treatment, and potentially reduce any conflict in decisions between parents, children or young people, and healthcare providers.
The quality of information provided has been shown to be a key facilitator in promoting shared decision-making in paediatric settings, although the ability to make decisions based on this information also depends on clarity with which this information is shared and an individual’s capacity to utilise this information.
Information about risks and benefits can be presented in a variety of formats. The most appropriate format for an individual child or young person will vary according to a number of factors including their age and cognitive development, their medical condition and the complexity of any interventions under consideration. Information also needs to be contextualised and personalised in order to make it most relevant to the individual.
The aim of this review is to determine the best way to help children and young people and the parents and carers of babies and young children understand the risks and benefits of healthcare decisions.
Summary of the protocol
See Table 1 for a summary of the Population, Intervention, Comparison and Outcome (PICO) characteristics of this review.
Table 1
Summary of the protocol (PICO table).
For further details, see the review protocol in appendix A.
Methods and process
This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual. Methods for this review question are described in the review protocol in appendix A and the methods supplement.
Clinical evidence
Included studies
This was a quantitative review with the aim of:
- Establishing how the risks and benefits of healthcare-relevant decisions (e.g. about treatment alternatives) should be communicated to children and young people and the parents/carers of babies and young children in order to support informed decision making.
A systematic review of the literature was conducted. Five studies were included for this review, 4 randomised controlled trials (RCTs) and 1 systematic review (Hulin 2017, Parker 2017, Robbins 2003 and Rowe 2018, Wyatt 2015).
The RCTs included the following comparisons:
- Comparison 1: a decision aid plus conventional clinical counselling versus conventional clinical counselling alone, in decisions regarding dental anaesthesia (Hulin 2017)
- Comparison 2: a decision aid plus standard information versus standard information alone, in adolescents contemplating orthodontic fixed appliances (Parker 2017)
- Comparison 3: an information booklet for new parents plus a home visit versus standard care, for minor illnesses in infants (Robbins 2003)
- Comparison 4: a novel self-help decisional tool (My Self-Help Tool) versus the Childline webpage, in adolescents who had recently self-harmed (Rowe 2018)
- Comparison 5: this systematic review included studies that investigated the effectiveness of any decision aid tool in paediatric healthcare compared to a variety of control conditions (Wyatt 2015).
The included studies are summarised in Table 2.
See the literature search strategy in appendix B and study selection flow chart in appendix C.
Excluded studies
Studies not included in this review are listed, and reasons for their exclusion are provided in appendix K.
Summary of studies included in the evidence review
Summaries of the studies that were included in this review are presented in Table 2.
Table 2
Summary of included studies.
See the full evidence tables in appendix D and the forest plots in appendix E.
Summary of the evidence
Evidence was found for 3 of the pre-defined outcomes listed in the protocol: satisfaction, knowledge and decisional conflict. No evidence was found for adverse effects or congruence of decision.
Three studies used interventions for children and young people themselves. One study compared the use of a written booklet plus conventional counselling with conventional counselling only when making a decision regarding dental anaesthesia (Hulin 2017). At follow-up, knowledge of young people was significantly higher (better) in the intervention group compared to the control group. No difference between the groups was found for decisional conflict. A second study compared the use of a booklet decision aid plus standard information with standard verbal and written information alone when making decisions about fixed appliance in orthodontic treatment (Parker 2017). No difference was found between groups for decisional conflict. The final study compared the use of an interactive My Self-Help Tool decisional aid with a static written information source (Rowe 2018). No difference in decisional conflict was found between groups. The quality of evidence for all the above results was judged to be very low.
One study used an intervention designed for parents of babies, using a home visit plus an information booklet with standard care to inform parents of childhood illnesses and the healthcare options available to them (Robbins 2003). No difference was found in measures of parental knowledge. Evidence for this study was judged to be very low to low quality.
The systematic review included studies that considered the use of a wide variety of decisional aids with a range of comparators. These decisional aids were designed for children and young people, parents and carers, or healthcare professionals (Wyatt 2015). Knowledge was significantly higher (better) and decisional conflict was significantly lower (better) when using decisional aids. No difference was found between groups in degree of satisfaction. Evidence was judged to be very low quality and should be interpreted with caution due to concerns over the suitability of meta-analysing such a heterogeneous population, differences in each studies concept of shared decision-making, and the variety of study designs included, how the format of decisional aids might affect these measures or if certain healthcare areas were more suited to decisional aids.
Quality assessment of studies included in the evidence review
See the evidence profiles in appendix F.
Evidence from reference groups and focus groups
The children and young people’s reference groups and focus groups provided additional evidence for this review. A summary of the findings is presented in Table 3.
Table 3
Summary of the evidence from reference and focus groups.
See the full evidence summary in appendix M.
Evidence from national surveys
No evidence from the grey literature review of national surveys of children and young people’s experience was identified for this review so there is no evidence summary in appendix N.
Economic evidence
Included studies
A systematic review of the economic literature was conducted but no studies were identified which were applicable to this review question. A single economic search was undertaken for all topics included in the scope of this guideline. See supplementary material 6 for details.
Excluded studies
Economic studies not included in this review are listed, and reasons for their exclusion are provided in appendix K.
Summary of studies included in the economic evidence review
No studies were identified which were applicable to this review question.
Economic model
This review question was identified as an economic priority, however, no economic modelling was undertaken because there was insufficient effectiveness data.
The committee’s discussion of the evidence
Interpreting the evidence
The outcomes that matter most
When discussing the outcomes that matter most, the committee were aware that an effective decision aid has to be both acceptable and educational for children and young people, or the parents or carers of babies and young children, to ensure it is used and assists in their decision-making, and therefore satisfaction and knowledge of risks and benefits were prioritised as critical outcomes by the committee.
The committee recognised that using a decision aid incorrectly or misunderstanding the information it provided could lead to adverse outcomes and so they selected this as an important outcome. The committee also recognised that decision aids may lead to children and young people making decisions that were different to those made by others involved in the decision-making process, and therefore chose congruence as an important outcome. Finally, the committee recognised that children and young people might find it difficult to make decisions and so selected decisional conflict as an important outcome.
The quality of the evidence
The quality of each study was appraised using the Cochrane Risk of Bias tool for randomised studies Version 2. The quality of the systematic review was appraised using the Cochrane ROBIS tool for Systematic Reviews.
The overall quality of evidence was assessed using GRADE methodology and was judged as being very low to low quality. The main reason for downgrading the evidence was due to concerns about the risk of bias of included studies and imprecision in the effect estimates.
The included systematic review (Wyatt 2015) reported a meta-analysis of evidence on decision aids. The evidence was judged to be low quality due to concerns over risk of bias in the study design and indirectness in the population. As noted in the risk of bias assessment, the degree of heterogeneity of included studies was very high, and was due to a number of factors: the studies were conducted in a range of countries and various clinical settings, and most importantly the included decision aids varied widely from simple leaflets to intensive series of educational sessions. Additionally, the systematic review pooled a variety of study designs in the meta analysis (RCTs, non-randomised controlled trials and pre/post designs). Caution must therefore be taken when interpreting the results from the Wyatt 2015 systematic review, as the effects seen cannot be assigned to one particular type of decision aid.
No evidence was found for ‘adverse outcomes’ or ‘congruence’.
Benefits and harms
The committee discussed the fact that the included studies provided evidence for a limited number of specific methods of sharing risks and benefits information with children and young people and their parents or carers, but there was not enough evidence to recommend one specific method or decision aid over another. Because of this, the committee made a research recommendation about the relative effectiveness and acceptability of different decision aids.
However, taking the evidence as a whole, there was some evidence that use of decision aids increased knowledge of risks and benefits and may reduce decisional conflict. The committee noted that a general recommendation about using decision aids to help in shared decision-making had already been included in the guideline (based on qualitative evidence on shared decision-making). The evidence from this review therefore reinforced the validity of that recommendation.
Based on this evidence, and also on their knowledge and expertise, the committee made a recommendation that children and young people, and the parents or carers of babies and young children, should be offered information about the risks and benefits of healthcare options to allow them to make informed decisions, and agreed that this should be standard practice. The committee agreed that this information could be provided in a variety of formats. As they did not have evidence to recommend one format over another, they made recommendations relating to the principles that should be followed – for example that the information should be appropriate for the child or young person, in a format they could understand, and relevant to them. The committee also agreed that as well as providing the information, it was important that this information should be discussed, and questions answered, and what would be done to mitigate risk explained, and they made recommendations to this effect.
The data from the reference and focus groups provided more evidence that the committee used in addition to the evidence from the systematic literature review. The reference groups had considered a number of healthcare scenarios and there was a mix of views – some children and young people wanted to be informed of the risks, some were unsure and were worried that the risks would scare them, and others would not want to know the risks. Based on this evidence and their knowledge and experience, the committee made recommendations to ensure that personal preferences were taken into account, and that discussing risks and benefits might need to be phased and paced carefully so young people were not overwhelmed. The committee discussed whether children and young people could opt-out of being told about the risks completely, but agreed that for the purposes of obtaining informed consent it was the responsibility of the healthcare professional to inform them of the risks of any treatment options, and so the committee included this in the recommendations. The reference groups also mentioned in need for healthcare professionals to not only tell them about the risks, but also what is being done to mitigate those risks. However, the committee felt that this was already adequately covered in the recommendations they had made.
The committee agreed that, as with other discussions, children and young people might want to discuss risks and benefits without their parents or carers present and that this should be an option, and so they made a recommendation stating this.
The committee noted that the evidence from the reference groups was that it could help if measures to reduce risk could also be included in discussions about risk. The committee agreed that this reflected their experience too, and so made a recommendation relating to mitigation of risks.
There was no evidence for the outcomes of adverse events from use of decision aids, and the committee did not identify any specific harms from the evidence or from their recommendations. However, they realised it could be perceived as harmful to discuss the treatment risks with children and young people (and parents of babies and young children) as it might deter them from consenting to important treatment. However, they felt this was mitigated by their recommendations to recognise that some people may prefer not to know the risks, and that there should be opportunities to discuss concerns about risks, and what can be done to reduce risk.
Cost effectiveness and resource use
There was no existing economic evidence for this review. The committee discussed that ensuring that children and young people and the parents or carers of babies and young children are given information about the risks and benefits of healthcare options may take more time to have the necessary discussions or additional conversations, but that in many settings it was already standard practice. The committee noted that there may be differences in costs associated with various decision aids. For example, it may be more expensive to develop and provide interactive tools then compared with written information only. However, once a decision aid is developed it could potentially be used by thousands of children, young people and the parents or carers of babies and young children and any costs of such decision aids per user will be negligible. Moreover, the use of a particular decision aid is likely to be dictated by needs of a user and additional costs, if any, will be offset by benefits associated with shared decision making and people making informed choices about their healthcare, for example, improvements in their knowledge and a reduction in decisional conflict. All other recommendations reflect current practice and are not expected to result in additional resource use.
Recommendations supported by this evidence review
This evidence review supports recommendations 1.1.4 to 1.1.7 and 1.3.5 to 1.3.10 and the research recommendation on decision aids.
References
Hulin 2017
Hulin, J., Baker, S. R., Marshman, Z., Albadri, S., Rodd, H. D., Development of a decision aid for children faced with the decision to undergo dental treatment with sedation or general anaesthesia, International Journal of Paediatric Dentistry, 27, 344–355, 2017 [PubMed: 27684707]Parker 2017
Parker, K., Cunningham, S. J., Petrie, A., Ryan, F. S., Randomized controlled trial of a patient decision-making aid for orthodontics, American Journal of Orthodontics and Dentofacial Orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics, 152, 154–160, 2017 [PubMed: 28760277]Robbins 2003
Robbins, H., Hundley, V., Osman, L. M., Minor illness education for parents of young children, Journal of Advanced Nursing, 44, 238–47, 2003 [PubMed: 14641393]Rowe 2018
Rowe, Sarah L., Patel, Krisna, French, Rebecca S., Henderson, Claire, Ougrin, Dennis, Slade, Mike, Moran, Paul, Web-Based Decision Aid to Assist Help-Seeking Choices for Young People Who Self-Harm: Outcomes From a Randomized Controlled Feasibility Trial, JMIR Mental Health, 5, e10, 2018 [PMC free article: PMC5811653] [PubMed: 29382626]Wyatt 2015
Wyatt, K. D., List, B., Brinkman, W. B., Prutsky Lopez, G., Asi, N., Erwin, P., Wang, Z., Domecq Garces, J. P., Montori, V. M., LeBlanc, A., Shared Decision Making in Pediatrics: A Systematic Review and Meta-analysis, Academic Pediatrics, 15, 573–583, 2015 [PubMed: 25983006]
Appendices
Appendix A. Review protocol
Appendix B. Literature search strategies
Appendix C. Clinical evidence study selection
Appendix D. Clinical evidence tables
Appendix E. Forest plots
Appendix F. GRADE tables
Appendix G. Economic evidence study selection
Economic evidence study selection for review question: What are the best ways to help children and young people and the parents and carers of babies and young children understand the risks and benefits of healthcare decisions?
No economic evidence was identified which was applicable to this review question.
Appendix H. Economic evidence tables
Economic evidence tables for review question: What are the best ways to help children and young people and the parents and carers of babies and young children understand the risks and benefits of healthcare decisions?
No evidence was identified which was applicable to this review question.
Appendix I. Economic evidence profiles
Economic evidence profiles for review question: What are the best ways to help children and young people and the parents and carers of babies and young children understand the risks and benefits of healthcare decisions?
No economic evidence was identified which was applicable to this review question.
Appendix J. Economic analysis
Economic evidence analysis for review question: What are the best ways to help children and young people and the parents and carers of babies and young children understand the risks and benefits of healthcare decisions?
No economic analysis was conducted for this review question.
Appendix K. Excluded studies
Excluded studies for review question: What are the best ways to help children and young people and the parents and carers of babies and young children understand the risks and benefits of healthcare decisions?
Clinical studies
Table 11
Excluded studies and reasons for their exclusion.
Economic studies
No economic evidence was identified for this review. See supplementary material 6 for details.
Appendix L. Research recommendations
Appendix M. Evidence from reference groups and focus groups
Appendix N. Evidence from national surveys
Evidence from national surveys for review question: What are the best ways to help children and young people and the parents and carers of babies and young children understand the risks and benefits of healthcare decisions?
Methods for the grey literature review of national surveys and details of the surveys included are described in Supplement 5.
No evidence from the grey literature review of national surveys of children and young people’s experience was identified for this review question.
Final
Evidence reviews underpinning recommendations 1.1.4 to 1.1.7 and 1.3.5 to 1.3.10 and research recommendations in the NICE guideline
These evidence reviews were developed by the National Guideline Alliance which is a part of the Royal College of Obstetricians and Gynaecologists
Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.
NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.