Patients' perspectives on quality and patient safety failures: lessons learned from an inquiry into transvaginal mesh in Australia.
Innovative surgery
Patient harm
Quality and patient safety
Senate Inquiry
Transvaginal mesh
Journal
BMC health services research
ISSN: 1472-6963
Titre abrégé: BMC Health Serv Res
Pays: England
ID NLM: 101088677
Informations de publication
Date de publication:
08 Apr 2024
08 Apr 2024
Historique:
received:
17
11
2023
accepted:
27
02
2024
medline:
11
4
2024
pubmed:
11
4
2024
entrez:
10
4
2024
Statut:
epublish
Résumé
Transvaginal mesh (TVM) surgeries emerged as an innovative treatment for stress urine incontinency and/or pelvic organ prolapse in 1996. Years after rapid adoption of these surgeries into practice, they are a key example of worldwide failure of healthcare quality and patient safety. The prevalence of TVM-associated harms eventually prompted action globally, including an Australian Commonwealth Government Senate Inquiry in 2017. We analysed 425 submissions made by women (n = 417) and their advocates (n = 8) to the Australian Senate Inquiry, and documents from 5 public hearings, using deductive and inductive coding, categorisation and thematic analysis informed by three 'linked dilemmas' from healthcare quality and safety theory. We focused on women's accounts of: a) how harms arose from TVM procedures, and b) micro, meso and macro factors that contributed to their experience. Our aim was to explain, from a patient perspective, how these harms persisted in Australian healthcare, and to identify mechanisms at micro, meso and macro levels explaining quality and safety system failure. Our findings suggest three mechanisms explaining quality and safety failure: 1. Individual clinicians could ignore cases of TVM injury or define them as 'non-preventable'; 2. Women could not go beyond their treating clinicians to participate in defining and governing quality and safety; and. 3. Health services set thresholds for concern based on proportion of cases harmed, not absolute number or severity of harms. We argue that privileging clinical perspectives over patient perspectives in evaluating TVM outcomes allowed micro-level actors to dismiss women's lived experience, such that women's accounts of harms had insufficient or no weight at meso and macro levels. Establishing system-wide expectations regarding responsiveness to patients, and communication of patient reported outcomes in evaluation of healthcare delivery, may help prevent similar failures.
Sections du résumé
BACKGROUND
BACKGROUND
Transvaginal mesh (TVM) surgeries emerged as an innovative treatment for stress urine incontinency and/or pelvic organ prolapse in 1996. Years after rapid adoption of these surgeries into practice, they are a key example of worldwide failure of healthcare quality and patient safety. The prevalence of TVM-associated harms eventually prompted action globally, including an Australian Commonwealth Government Senate Inquiry in 2017.
METHOD
METHODS
We analysed 425 submissions made by women (n = 417) and their advocates (n = 8) to the Australian Senate Inquiry, and documents from 5 public hearings, using deductive and inductive coding, categorisation and thematic analysis informed by three 'linked dilemmas' from healthcare quality and safety theory. We focused on women's accounts of: a) how harms arose from TVM procedures, and b) micro, meso and macro factors that contributed to their experience. Our aim was to explain, from a patient perspective, how these harms persisted in Australian healthcare, and to identify mechanisms at micro, meso and macro levels explaining quality and safety system failure.
RESULTS
RESULTS
Our findings suggest three mechanisms explaining quality and safety failure: 1. Individual clinicians could ignore cases of TVM injury or define them as 'non-preventable'; 2. Women could not go beyond their treating clinicians to participate in defining and governing quality and safety; and. 3. Health services set thresholds for concern based on proportion of cases harmed, not absolute number or severity of harms.
CONCLUSION
CONCLUSIONS
We argue that privileging clinical perspectives over patient perspectives in evaluating TVM outcomes allowed micro-level actors to dismiss women's lived experience, such that women's accounts of harms had insufficient or no weight at meso and macro levels. Establishing system-wide expectations regarding responsiveness to patients, and communication of patient reported outcomes in evaluation of healthcare delivery, may help prevent similar failures.
Identifiants
pubmed: 38600470
doi: 10.1186/s12913-024-10791-w
pii: 10.1186/s12913-024-10791-w
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
436Subventions
Organisme : Wiser Healthcare
ID : NHMRC APP2006545
Organisme : Wiser Healthcare
ID : NHMRC APP2006545
Organisme : Wiser Healthcare
ID : NHMRC APP2006545
Informations de copyright
© 2024. The Author(s).
Références
Heneghan CJ, Goldacre B, Onakpoya I, Aronson JK, Jefferson T, Pluddemann A, Mahtani KR. Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process. BMJ open. 2017;7(12):e017125. https://bmjopen.bmj.com/content/7/12/e017125.info .
doi: 10.1136/bmjopen-2017-017125
pubmed: 29212782
pmcid: 5728256
Karmakar D, Hayward L. What can we learn from the vaginal mesh story? Climacteric. 2019;22(3):277–82. https://doi.org/10.1080/13697137.2019.1575355 .
doi: 10.1080/13697137.2019.1575355
pubmed: 30829077
Motamedi M, Carter SM, Degeling C. Women’s experiences of and perspectives on transvaginal mesh surgery for stress urine incontinency and pelvic organ prolapse: a qualitative systematic review. Patient-Patient-Centered Outcomes Res. 2022 Mar;1–3. https://doi.org/10.1007/s40271-021-00547-7 .
Fricker M. Epistemic injustice: power and the ethics of knowing. Oxford: Oxford University Press; 2007.
doi: 10.1093/acprof:oso/9780198237907.001.0001
Waring J, Allen D, Braithwaite J, Sandall J. Healthcare quality and safety: a review of policy, practice and research. Sociol Health Illn. 2016;38(2):198–215. https://doi.org/10.1111/1467-9566.12391 .
doi: 10.1111/1467-9566.12391
pubmed: 26663206
Larson MS. The rise of professionalism. London: Transaction Books; 2013.
Le Fanu J. The rise and fall of Modern Medicine. London: Little Brown Book Group; 2011.
Grober ED, Bohnen JM. Defining medical error. Can J Surg. 2005;48(1):39. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3211566/ .
pubmed: 15757035
pmcid: 3211566
Gabe J, Burry M, Elston MA. Part 5, Health Care Organization and Policy. Key concepts in medical sociology. London: SAGE; 2004. pp. 203–8.
Australian Parliament Senate Community Affairs References Committee. Number of women in Australia who have had transvaginal mesh implants and related matters. Commonwealth of Australia. Parliament House, Canberra.; 2018. pp. 1–168. https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants/Report .
O’Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. Standards for reporting qualitative research: a synthesis of recommendations. Acad Med. 2014;89(9):1245–51. https://doi.org/10.1097/ACM.0000000000000388 .
doi: 10.1097/ACM.0000000000000388
pubmed: 24979285
Oxlad M, Edwards G, McKinlay KA. Patients’ perspectives about doctor-patient communication regarding transvaginal mesh implant surgery. Patient Educ Couns. 2022;105(12):3534–9. https://www.sciencedirect.com/science/article/abs/pii/S0738399122004013 .
doi: 10.1016/j.pec.2022.08.021
pubmed: 36114043
McKinlay KA, Oxlad M. ‘I have no life and neither do the ones watching me suffer’: women’s experiences of transvaginal mesh implant surgery. Psychol Health 2022 Sep 15:1–22. https://doi.org/10.1080/08870446.2022.2125513 .
Ducey A, Donoso C, Ross S, Robert M. The (commercialised) experience of operating: embodied preferences, ambiguous variations and explaining widespread patient harm. Sociol Health Illn. 2023;45(2):346–65. https://doi.org/10.1111/1467-9566.13579 .
doi: 10.1111/1467-9566.13579
pubmed: 36382531
Bosk CL, Pedersen KZ. Blind spots in the science of safety. Lancet. 2019;393(10175):978–9. https://doi.org/10.1016/S0140-6736(19)30441-6 .
doi: 10.1016/S0140-6736(19)30441-6
pubmed: 30860042
Independent Medicines and Medical Devices Safety Review. First Do No Harm: The Report of the Independent Medicines and Medical Devices Safety Review. 2020 Jul. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf .
Clinical Excellence Commission. New South Wales (AU): Guidelines for Conducting and Reporting, Morbidity, and Mortality/Clinical Review Meetings.; 2020. Available from: Guidelines for ConductingReporting MorbidityMortality/Clinical Review Meetings (nsw.gov.au).
Australian Commission on Safety and Quality in Health Care. Sydney (Au): The state of patient safety and quality in Australian hospitals 2019. Available from: https://www.safetyandquality.gov.au/sites/default/files/2019-07/the-state-of-patient-safety-and-quality-in-australian-hospitals-2019.pdf .
Lokugamage AU, Robinson N, Pathberiya SD, Wong S, Douglass C. Respectful maternity care in the UK using a decolonial lens. SN Social Sci. 2022;2(12):267. https://doi.org/10.1007/s43545-022-00576-5 .
doi: 10.1007/s43545-022-00576-5
Motamedi M, Carter SM, Degeling C. Transvaginal mesh in Australia: an analysis of news media reporting from 1996 to 2021. Health Expect. 2023 Feb;22. https://doi.org/10.1111/hex.13734 .
Heneghan C, Thompson M. Rethinking medical device regulation. J R Soc Med. 2012;105(5):186–8.
doi: 10.1258/jrsm.2012.12k030
pubmed: 22637765
pmcid: 3360534