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Global considerations for informed consent with shared decision-making in the digital age
  1. Edward Robert St John1,2,3,
  2. Connor James Stewart Moore3,
  3. Raghu Ram Pillarisetti4,
  4. Erica Sarah Spatz5
  1. 1Department of Breast Surgery, Portsmouth Hospitals University NHS Trust, Portsmouth, UK
  2. 2University of Portsmouth, Portsmouth, UK
  3. 3Concentric Health, Cardiff, UK
  4. 4KIMS-USHALAKSHMI Centre for Breast Diseases, Krishna Institute of Medical Sciences Secunderabad Hospital, Secunderabad, India
  5. 5Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut, USA
  1. Correspondence to Mr Edward Robert St John, Department of Breast Surgery, Portsmouth Hospitals University NHS Trust, Portsmouth, UK; edward.stjohn{at}

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Shared decision-making (SDM) is increasingly recognised as fundamental to patient-centred care and enabling patients to make voluntary, informed decisions about their health.1 SDM is the process whereby patients and clinicians come together to share their expertise. The patient acts as an expert of themselves, understanding their own preferences and their attitudes to risk. The clinician is an expert on the medical knowledge and scientific evidence. Together, treatment options should be explored, arriving at a treatment decision that is right for the patient and supported by the clinician. When dealing with invasive or high-risk procedures (eg, operations, chemotherapy, radiotherapy, immunotherapy), once the treatment decision has been made, the conversation turns to informed consent. This is the process of communicating and agreeing to the potential risks and benefits of the procedure, while acknowledging that there are alternative treatment options that have not been chosen. Though informed consent should be the culmination of SDM, alone it does not encapsulate the entire process. There is a distinction between decision-making and consent and this should ideally be accompanied by a period for reflection. Despite advances in SDM, the subsequent informed consent process has remained stagnant, often failing to meet ethical or legal standards of supporting meaningful patient autonomy.2

In reality, rapid surgical decisions may be required (e.g. emergency or cancer pathways), where time is a precious commodity to deliver optimal patient care. In these scenarios, it is common for discussions to move quickly from diagnosis to treatment options, to consent. However, scarcity of clinician time should not be an excuse for inadequate consent. Therefore, reimagining the consent process in the digital age by ensuring the benefits, risks and alternative treatment options are clearly and correctly presented as early as possible, has the ability of transforming this step from a ritualised gesture into a …

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  • ERSJ and CJSM are joint first authors.

  • X @ercstjohn, @RRPillarisetti

  • Contributors ERSJ and CJSM are joint first authors. All authors provided substantial contributions to the conception and design of the work and drafting the work, and revising it critically for important intellectual content and final approval of the version to be published; and agreement 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.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests ERSJ is the Co-Founder and Chief Medical Officer of Concentric Health and has equity in the company. CJSM is an employee of Concentric Health. Concentric Health is a company that develops digital informed consent software. The other authors declare no conflict of interests related to this work. The authors have aimed to evaluate informed consent models objectively, drawing on best practices and academic research.

  • Provenance and peer review Not commissioned; externally peer reviewed.