&lt;p&gt;Health literacy and informed consent for clinical trials: a systematic review and implications for nurses&lt;/p&gt;

Burks, Allison C; Keim‐Malpass, Jessica

doi:10.2147/nrr.s207497

Cited by 18 publications

(16 citation statements)

References 24 publications

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“…Prognostication is challenging. However, diabetes is known to reduce life expectancy compared to the general population and there are some well-described general indicators of declining life expectancy (30). In addition, our literature review for the current study revealed seven main diabetes-related factors associated with reduced life expectancy: duration of diabetes, glycaemia, comorbid load/ geriatric syndromes, severe hypoglycaemia, lower limb and foot disease, polypharmacy and comorbid depression (11).…”

Section: Discussionmentioning

confidence: 84%

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Discussing diabetes, palliative and end of life care: choosing the ‘right’ language

Dunning¹,

Martin²,

Milnes³

et al. 2021

Ann Palliat Med

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Background: Palliative care and advance care planning are important components of diabetes and other chronic disease management plans. Most people with diabetes do not have conversations about palliative/end of life (EOL) care or advance care directives; often because diabetes clinicians are reluctant to discuss these issues. Guidelines for conversations and decision aids can assist shared decision-making for both clinicians and patients. The aim was to co-design information with older people with diabetes, families and clinicians to facilitate conversations about palliative and EOL care and to identify the language (words) people with diabetes, families and diabetes clinicians use to discuss death and dying Methods: We co-designed and tailored the information with advisory groups: (I) older people with diabetes/families, (II) interdisciplinary expert clinicians and undertook a scoping literature review to identify relevant content. The penultimate versions were independently evaluated in focus groups and via written feedback from representative stakeholder clinicians, people with diabetes and international experts in communication, palliative care and diabetes.Results: The information met design and language criteria: 62 people participated in focus groups (48 clinicians, 14 older people with diabetes and 4 family members). There were important differences between people with diabetes and diabetes clinicians concerning the words used to refer to death: 'the language of death'. Diabetes clinicians choose soft words/euphemisms such as 'passed away' and 'gone' and indicated they mirrored patient language. People with diabetes preferred clear language and indicated euphemisms were confusing and misleading. Diabetes clinicians, rarely encountered death in their practice and indicated they lacked education about how to discuss diabetes EOL care.Conclusions: Co-design with key end-users improved relevance to these groups. Diabetes clinicians prefer to use euphemisms for death and would benefit from education and strategies to help them initiate conversations about EOL diabetes care.

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Section: Discussionmentioning

confidence: 84%

“…Mirroring may also contain elements of health literacy. Health literacy is important to quality care and can affect patients' decisions and actions (30). However, clinician health literacy is rarely considered and can also have a profound effect on outcomes.…”

Section: Discussionmentioning

confidence: 99%

Discussing diabetes, palliative and end of life care: choosing the ‘right’ language

Dunning¹,

Martin²,

Milnes³

et al. 2021

Ann Palliat Med

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“…A patient’s health literacy is an important component of high-quality care that can influence on clinical decisions and actions of patients and providers. 25 Adequate health literacy and a better understanding of health education are highly correlated. 20 Those patients having low health literacy reported less participation in their care with the clinician, which in turn results in poorer health outcomes.…”

Section: Discussionmentioning

confidence: 99%

Level of Patient Health Literacy and Associated Factors Among Adult Admitted Patients at Public Hospitals of West Shoa Oromia, Ethiopia

Dugasa¹

2022

PPA

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Background Health literacy is a capacity of individual to gain knowledge that helps to use health information in different levels as needed for self-management and to communicate with health providers. Health literacy has a significant impact on patient health outcomes. The aim of this study was to assess level of patient health literacy and associated factors among adult admitted patients at public hospitals of West Shoa zone, Oromia, Ethiopia. Methods A cross-sectional, quantitative study was carried out among adult admitted patients at public hospitals of West Shoa Oromia, Ethiopia. An interviewer-administered Health Literacy Questionnaire (HLQ) instrument tool was used to assess patients’ health literacy. All statistical analysis were performed using SPSS for windows program version 21. Results A total of 403 patients participated in this study. Majority of the participants were males 235 (58.3%) and aged 40–59 years (n = 164, 40.7%). Overall, 59.1% (n = 238) of the participants have high health literacy. Those respondents who are above grade 12 (tertiary) were 2.45 times more likely to have high health literacy (AOR = 2.45, 95% CI: 1.21, 4.98) compared to those respondents not able to read and write . Participants who had age greater or equal to sixty were 65% less likely to have high health literacy (AOR: 0.35, 95% CI: 0.18, 0.70). Conclusion and Recommendation Forty percent of the participants have low health literacy. Age and education are significant factors in health literacy. Ethiopian ministry of health, Oromia regional health bureau, West shoa zonal office and healthcare professionals have to provide an intervention in enhancing the level of health literacy by mass media and written material.

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“…answering multi-choice questions, notating the information, or researchers using techniques such as the teach-back method to ensure explanations are effective) and build a rapport with the researcher. 52,85,89 Meanwhile, researchers must promote transparency by declaring their conflict of interest; empathy with participants' welfare against meeting enrolment goals. 84 Assessing health literacy and patient comprehension.…”

Section: Potential Strategies To Improve Informed Consent In Haemophilia Gene Therapymentioning

confidence: 99%

Improving patient informed consent for haemophilia gene therapy: the case for change

Woollard¹,

Gorman

Rosenfelt

2021

Therapeutic Advances in Rare Disease

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Adeno-associated virus-based gene therapy points to a coming transformation in the treatment of people living with haemophilia, promising sustained bleed control and potential improvement in quality of life. Nevertheless, the consequences of introducing new genetic material are not trivial. The perceived benefits should not minimise the challenges facing patients in understanding the long-term risks and providing a valid and meaningful informed consent, whether in a research or clinical setting. Informed consent is a fundamentally important doctrine in both medical ethics and health law, upholding an individual’s right to define their personal goals and make their own autonomous choices. Patients should be enabled to recognise their clinical situation, understand the implications of treatment and integrate every facet of their life into their decision. This review describes informed consent processes for haemophilia gene therapy clinical trials, factors affecting patients’ decision making and the availability of patient-centred decision support interventions, to ensure that patients’ interests are being protected. Regulatory guidance has been published for physicians and manufacturers in haemophilia on informed consent, including for gene therapy, while best-practice recommendations for patient–physician discussions are available. In all settings, however, communicating and presenting highly technical and complex therapeutic information is challenging, especially where multiple barriers to scientific knowledge and health literacy exist. We propose several evidence-informed strategies to enhance the consent procedure, such as utilising validated literacy and knowledge assessment tools as well as participatory learning environments over an extended period, to ensure that patients are fully cognisant of the consent they give or deny. Further research is needed to define new, creative approaches for patient education and the upholding of ethical values in the informed consent process for gene therapy. The lessons learnt and approaches developed within haemophilia could set the gold standard for good practice in ensuring ethical preparedness amidst advances in genetic therapies. Plain language summary Improving the informed consent process for people living with haemophilia considering gene therapy. Gene therapy is the process of replacing faulty genes with healthy ones. In haemophilia, gene therapy involves introducing a working copy of the gene for the clotting factor that patients are missing. Following treatment, patients should begin producing their own clotting factor normally. However, people living with haemophilia (PwH) need to be fully informed regarding the potential benefits and risks of gene therapy and what this means for them, whether as part of a research study or routine medical care. Patients must be respected and supported to make decisions about their own health and wellbeing, recognising their legal and moral right to set personal goals and make treatment choices. For this to happen in practice, patients should be aware of their individual health needs, understand the effects of treatment and consider lifestyle preferences in relation to their decisions. This article attempts to describe how informed consent is obtained in haemophilia gene therapy clinical trials, what affects a patient’s ability to make decisions and the availability of information and support to respect and protect the interests of PwH. Regulators responsible for approving medical products have published guidance on informed consent for physicians and pharmaceutical manufacturers in haemophilia, including for gene therapy. Recommendations have been made about the best ways for PwH to discuss gene therapy with their physicians. Yet, poor communication of complex topics, such as gene therapy, can be problematic, especially if patients lack the skills and confidence to understand and discuss the science, or for physicians with limited time in clinic. We propose strategies to improve the consent process, so patients can feel more able to make informed decisions about new treatments. Further research is needed to find new, creative approaches for educating patients and ensuring that the informed consent process for gene therapy in haemophilia is ethical.

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<p>Health literacy and informed consent for clinical trials: a systematic review and implications for nurses</p>

Cited by 18 publications

References 24 publications

Discussing diabetes, palliative and end of life care: choosing the ‘right’ language

Discussing diabetes, palliative and end of life care: choosing the ‘right’ language

Level of Patient Health Literacy and Associated Factors Among Adult Admitted Patients at Public Hospitals of West Shoa Oromia, Ethiopia

Improving patient informed consent for haemophilia gene therapy: the case for change

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