Aims: This study investigates the effectiveness and adequacy of the informed consent process for patients undergoing hip fracture surgery. While informed consent is a legal and ethical responsibility, factors in the trauma setting can impair patients' understanding and retention of information. This study seeks to evaluate patients' recall of perioperative complications and explore their perceptions of the consent process. Methods: A mixed-methods, multicentre cohort study will be conducted in the Southeast of Scotland. Adult patients with hip fractures will be recruited via purposive sampling. An information recall questionnaire will be administered within 36 hours of admission to assess unprompted and prompted recall of complications. A subset of participants will then undergo a semi-structured qualitative interview postoperatively to explore their experiences and perceptions of the consent process. Data will be analyzed using a social constructivist grounded theory to assess their perceptions of consent. Ethical approval has been granted by the East of England Research Ethics Committee (reference 23/EE/0233). Conclusion: Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences. The study results will identify challenges in the consent process, particularly in how risks are communicated and understood. The data are expected to inform the development of information aids and enhance the ability of orthopaedic surgeons to provide comprehensive, patient-centred consent.
References
No authors listed . Consent: supported decision-making a guide to good practice . Royal College of Surgeons . https://www.rcseng.ac.uk/standards-and-research/standards-and-guidance/good-practice-guides/consent/ ( date last accessed 14 February 2025 ).
Ring J , Talbot C , Cross C , Hinduja K . NHSLA litigation in hip fractures: lessons learnt from NHSLA data . Injury . 2017 ; 48 ( 8 ): 1853 – 1857 . 10.1016/j.injury.2017.06.009 28648408
No authors listed . All claims with the specialty codes plastic surgery and orthopaedic surgery from years 2014 up to 2020 . NHS Litigation Authority . 2014 . https://resolution.nhs.uk/wp-content/uploads/2021/02/FOI_4903_Plastic-Surgery-and-Orthopaedic-Surgery.pdf ( date last accessed 14 February 2025 ).
No authors listed . Montgomery v Lanarkshire Health Board . UK Supreme Court . https://www.supremecourt.uk/cases/docs/uksc-2013-0136-judgment.pdf ( date last accessed 14 February 2025 ). 10.1111/1471-0528.14501 28128505
No authors listed . Decision making and consent . General Medical Council . 2008 . https://www.gmc-uk.org/professional-standards/the-professional-standards/decision-making-and-consent ( date last accessed 14 February 2025 ).
Howard A , Webster J , Quinton N , Giannoudis PV . “Hobson’s choice”: a qualitative study of consent in acute surgery . BMJ Open . 2020 ; 10 ( 10 ): e037657 . 10.1136/bmjopen-2020-037657 33033090
Isherwood J , Dean B , Pandit H . Documenting informed consent in elective hip replacement surgery: a simple change in practice . Br J Hosp Med (Lond) . 2013 ; 74 ( 4 ): 224 – 227 . 10.12968/hmed.2013.74.4.224 23571394
Jeyaseelan L , Ward J , Papanna M , Sundararajan S . Quality of consent form completion in orthopaedics: are we just going through the motions? J Med Ethics . 2010 ; 36 ( 7 ): 407 – 408 . 10.1136/jme.2010.035592 20605994
Smith HK , Manjaly JG , Yousri T , et al. Informed consent in trauma: does written information improve patient recall of risks? A prospective randomised study . Injury . 2012 ; 43 ( 9 ): 1534 – 1538 . 10.1016/j.injury.2011.06.419 21782171
Alomar AZ . Confidence level, challenges, and obstacles faced by orthopedic residents in obtaining informed consent . J Orthop Surg Res . 2021 ; 16 ( 1 ): 390 . 10.1186/s13018-021-02531-1 34140032
Charmaz K , Thornberg R . The pursuit of quality in grounded theory . Qualitative Research in Psychology . 2021 ; 18 ( 3 ): 305 – 327 . 10.1080/14780887.2020.1780357
Creswell J , Clark V , Gutmann M , Hanson W . Advanced mixed methods research designs . In : Tashakkori A , Teddlie C . Handbook of Mixed Methods in Social and Behavioral Research . Thousand Oaks, CA : Sage , 2003 : 209 – 240 .
Bellelli G , Morandi A , Davis DHJ , et al. Validation of the 4AT, a new instrument for rapid delirium screening: a study in 234 hospitalised older people . Age Ageing . 2014 ; 43 ( 4 ): 496 – 502 . 10.1093/ageing/afu021 24590568
Braun V , Clarke V . Using thematic analysis in psychology . Qual Res Psychol . 2006 ; 3 ( 2 ): 77 – 101 . 10.1191/1478088706qp063oa
Herrera-Pérez M , González-Martín D , Sanz EJ , Pais-Brito JL . Ethical dilemmas with regard to elderly patients with hip fracture: the problem of nonagenarians and centenarians . J Clin Med . 2022 ; 11 ( 7 ): 1851 . 10.3390/jcm11071851 35407459
Waran E , William L . Hip fractures and dementia: clinical decisions for the future . Oxf Med Case Rep . 2016 ; 2016 ( 2 ): 19 – 21 . 10.1093/omcr/omw001 26949537
Bhangu A , Hood E , Datta A , Mangaleshkar S . Is informed consent effective in trauma patients? J Med Ethics . 2008 ; 34 ( 11 ): 780 – 782 . 10.1136/jme.2008.024471 18974409
Betti S , Sironi A , Saino G , Ricci C , Bonavina L . Effect of the informed consent process on anxiety and comprehension of patients undergoing esophageal and gastrointestinal surgery . J Gastrointest Surg . 2011 ; 15 ( 6 ): 922 – 927 . 10.1007/s11605-011-1517-7 21484486
Hallock JL , Rios R , Handa VL . Patient satisfaction and informed consent for surgery . Am J Obstet Gynecol . 2017 ; 217 ( 2 ): 181 . 10.1016/j.ajog.2017.03.020 28363439