1051 Procedure-Specific Consent Forms in Clinical Practice: A Systematic Review

Abstract

Abstract Aim Consent forms play an active role in the consent process. Generic, hand-written consent forms are used as the standard across the NHS. However, increasingly procedure-specific consent forms (PSCF) are being used as an alternative. Their proponents suggest PSCF improve the consent process however concerns remain about whether they meet the standard for consent. We therefore conducted the first review evaluating the use of PSCF in clinical practice and give suggestions regarding their future use. Method A literature review was conducted via PubMed using the key terms ‘pre-printed consent form’ and ‘procedure-specific consent form'. Results Few studies investigating PSCF in clinical practice were identified including no systematic reviews. Most studies identified were quality improvement projects. However, no studies assessed the role of PSCF in litigation after procedural complications. PSCF were associated with improved legibility, documentation and patient understanding versus generic consent forms. PSCF generally improved documentation of procedure-specific complications and risks versus generic consent forms. PSCF are not routinely used in clinical practice and are not endorsed by the Department of Health and Royal College of Surgeons. There is no definitive legal guidance attesting to their use in the consent process, despite concerns their use will lead to procedures and associated complications not being fully explained to patients. Conclusions Evidence supporting the use of PSCF is available however it is heterogeneous and substantial legal concerns remain. Additional, high-quality studies evaluating their use is warranted, including their impact on medico-legal claims. Finally, a collaborative approach between clinicians and those within the legal profession is necessary.