On clinical guidelines

What is the issue?

 
This page is part of a series of briefings summarising key and interrelated issues for the intersex movement in Australia, and our work:

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We have been asked to consider proposals for national or state/territory guidelines in response to human rights violations affecting children with intersex variations in medical settings. This policy briefing considers whether or not guidelines are enough to ensure medical interventions on infants, children and adolescents with intersex variations conform to human rights norms, and eliminate harmful so-called ‘normalising’ interventions. Reviewing the evidence on clinical practice guidelines, we believe they are insufficient.

Reflecting the Darlington Statement, IHRA calls for legislative reform to eliminate forced and coercive practices, in combination with independent oversight to ensure transparency and accountability, support for parents, families and individuals, and standards of care.

Clinical practice guidelines

Clinical practice guidelines (‘CPGs’) are ‘systemically developed statements’ designed to assist in clinical decision-making that have become a ‘familiar part of clinical practice’ with the aim of promoting ‘more consistent and efficient’ care, ‘closing the gap between what clinicians do and what scientific evidence supports’ (Woolf et al. 1999, 527). Guidelines necessarily draw on scientific and clinical evidence to construct best practice. Where guidelines exist, adherence is known to be mixed and sometimes poor. In a systemic review of barriers to clinical adherence to guidelines, Cabana et al. (1999) identify barriers including:

  • knowledge, such as lack of familiarity or awareness of the guidelines or their applicability
  • clinician attitudes or sentiment, including lack of agreement with specific guidelines; for example, through a different interpretation of evidence, or lack of agreement with guidelines in principle; lack of motivation or inertia; lack of belief in ability to perform a recommendation; or a lack of confidence regarding outcomes
  • behavioural barriers, including patient factors such as irreconcilable characteristics or preferences
  • contradictory guidelines or other issues with the guidelines
  • environmental factors (Cabana et al. 1999, 1459).

Cabana et al. report that ‘lack of agreement as a barrier for a specific guideline was as high as 91%’ citing an example for that high range figure in the paediatric field, in a recommendation by the American Academy of Pediatrics (Cabana et al. 1999, 1460) Specific issues associated with lack of agreement include a lack of perceived credibility, and a perceived limit on clinician autonomy (Cabana et al. 1999, 1461).

While this material is dated, it forms part of current debate in Australian hospitals (Steele 2019).

Adherence to clinical guidelines in Australia

A 2018 study of clinical adherence based on quality indicators drawn from ’17 common, high-burden clinical conditions’ sampled medical records to evaluate the care of 6689 children in 3 Australian states. It found that ‘Adherence to quality of care indicators was estimated at 59.8%’, concluding that ‘the overall prevalence of adherence to quality of care indicators for important conditions was not high’ (Braithwaite et al. 2018, 1113). The authors state that:

Adherence gaps and practice variation persist despite decades of development and endorsement of CPGs designed to promote the uptake of evidence into routine practice and to standardize care. The problems with CPGs have been well described and include redundancy, lack of currency, inconsistent structure and content, voluminous documents, and concerns about the quality of evidence on which CPGs are based (Braithwaite et al. 2018, 1122).

Similarly, a study published in 2020 of clinical adherence to guidelines relating to pregnant women with cardiac conditions in South Australia between 2003 and 2013 found ‘overall suboptimal adherence to the statewide guidelines for’ that population (Millington et al. 2020, 2).

Further, clinical guidelines are not intended to be applied universally, but instead allow for clinical judgement. For example, the authors of the South Australian study reported that ‘it is reasonable not to expect 100% concordance with the guidelines’ (Millington et al. 2020, 10), stating ‘guidelines should contain realistic and clear recommendations, which allow individual clinical judgement orientated for the patient as for efficacy versus safety’ (Millington et al. 2020, 16).

Intersex specific guidelines

Spin cycle
Guidelines for medical interventions relating to intersex variations are scarce, though increasing in number, and contested. A 2006 clinical “consensus” statement is frequently cited as a foundational text for the clinical management of intersex traits, but is contested as it facilitates medical interventions for psychosocial rationales such as managing ‘parental distress’ (Hughes et al. 2006, 557) and ‘mitigating’ ‘gender-identity confusion of atypical genital appearance’ (Houk et al. 2006, 755). Aronowitz (2004) describes the role of clinical ‘consensus’ panels as a means of ‘legitimating poorly understood’ and often poorly evidenced ‘symptom-based diagnoses that ultimately derive from social influences’ (Carpenter 2018, 453–54). That is, ‘consensus’ statements attempt to construct clinical norms based on an appeal to clinical eminence.

Guidelines in relation to genital surgical indications, necessity, timing and methods is absent or low quality, and different sets of clinical guidelines conflict. Prior to winding up, the Intersex Society of North America produced guidelines (Consortium on the Management of Disorders of Sex Development et al. 2006) that have never been clinically accepted (Zillén, Garland, and Slokenberga 2017, 42). The Consortium guidelines are dated, fail to address human rights considerations and conflicting rationales in the 2006 ‘consensus’ statement, and treat intersex people necessarily as patients (Intersex Human Rights Australia 2018, 79), yet the Committee on Bioethics of the Council of Europe states that ‘No other protocol has emerged to explain, as a matter of science, how infant surgery will be certain to coincide with the child’s actual identity, sexual interests, and desires for bodily appearance’ (Zillén, Garland, and Slokenberga 2017, 42).

A 2016 statement on intersex traits ‘with a gender issue’ identify psychosocial rationales as the primary goals of surgery, including heteronormative ideas of sexual activity and procreation (Mouriquand et al. 2016, 3). A 2018 CPG on congenital adrenal hyperplasia due to steroid 21-hydroxylase deficiency calls for clitorectomies in minors with parental consent when ‘surgery is chosen’ (Speiser et al. 2018, 4046–47). A 2018 European consensus statement cites a debate on surgery, while also identifying constraints on production of evidence as a factor, stating:

The lack of consensus is partially driven by a dearth of relevant, systematic data, which is due to the rarity of the conditions, the heterogeneity of presentations, the loss of patients from follow-up into adulthood and the long interval between surgery and time of data collection (Cools et al. 2018, 7).

Withheld medical histories and ‘possibility of negative medical experiences’ contribute to loss of patients to follow-up (Lee et al. 2016, 170). Double blind studies are likely unethical, and populations not subjected to medical intervention in high income countries are rare when pre-emptive surgery is prevalent. In addition, clinical reporting is known to be biased against publication of negative results (Earp 2017), including negative outcomes, and medical practitioners and researchers may be inhibited from reporting of surgical outcomes in a context where clinical papers themselves document human rights violations.

A decade after the 2006 clinical ‘consensus’ statement, evidence remains poor. A 2016 global clinical update identifies no consensus in key areas, with a reference to majority clinical eminence in a subset of areas:

There is still no consensual attitude regarding indications, timing, procedure and evaluation of outcome of DSD [‘disorder of sex development’] surgery. The levels of evidence of responses given by the experts are low (B and C), while most are supported by team expertise. Literature reports are primarily short clinical series that cannot be compared because of heterogeneous pathologies and management. However, most experts agree with (1) the need for identifying centers of expertise with a multidisciplinary approach [and four particular actions related to specific traits]. Timing, choice of the individual and irreversibility of surgical procedures are sources of concerns. There is no evidence regarding the impact of surgically treated or non-treated DSDs during childhood for the individual, the parents, society or the risk of stigmatization (Lee et al. 2016, 176)

The 2006 global clinical update concludes by noting that ‘the trend in recent years has been for legal and human rights bodies to increasingly emphasize preserving patient autonomy’ (Lee et al. 2016, 177), that is, by referencing ethical concerns.

The prerequisites for clinical guidelines do not exist

Guidelines do not provide mandatory rules for clinical practice, they depend on the availability of evidence, and acceptance of that evidence and norms by clinicians who hold varying attitudes and beliefs about treatment. Adherence even in relation to ‘high-burden’ clinical conditions in Australia is found to be poor. These factors provide a poor foundation for guidelines in relation to the clinical treatment of intersex people where the key questions are fundamentally about ethical and human rights considerations.

Our position

Our position is set out in the 2017 Darlington Statement, an Australian – Aotearoa/New Zealand intersex community declaration, where we call for a suite of interrelated reforms:

  • “prohibition as a criminal act of deferrable medical interventions, including surgical and hormonal interventions, that alter the sex characteristics of infants and children [born with variations of sex characteristics] without personal consent
  • “mandatory independent access to funded counselling and peer support [i.e. resourcing of intersex-led organisations to provide peer support, systemic advocacy and services]
  • “the implementation of advisory bodies to develop appropriate human rights-based, lifetime, intersex standards of care with full and meaningful participation by intersex community representatives and human rights institutions
  • clinical “Multi-disciplinary teams must operate in line with transparent, human rights-based standards of care for the treatment of intersex people and bodies. Multi-disciplinary teams in hospitals must include human rights specialists, child advocates, and independent intersex community representatives.
  • “independent, effective human rights-based oversight mechanism(s) to determine individual cases involving persons born with intersex variations who are unable to consent to treatment, bringing together human rights experts, clinicians and intersex-led community organisations”

We understand standards of care to be different to clinical practice guidelines. We understand standards of care to mean, at the very least, a set of human rights-affirming minimum standards for clinical practice that must be met. We envisage this to make reference to fundamental human rights norms including the right to bodily integrity and freedom from discrimination. We envisage an independent oversight mechanism to ensure adherence to those norms, and ensure transparency and accountability. We envisage legislative reform to establish these principles and frameworks.

Further reading

Androgen Insensitivity Syndrome Support Group Australia, Intersex Trust Aotearoa New Zealand, Organisation Intersex International Australia, Eve Black, Kylie Bond, Tony Briffa, Morgan Carpenter, et al. 2017. ‘Darlington Statement’. Sydney, New South Wales.

Aronowitz, Robert A. 2004. ‘When Do Symptoms Become a Disease?’ In Health, Disease, and Illness: Concepts in Medicine, edited by Arthur Caplan, James J McCartney, and Dominic A Sisti, 65–72. Washington, DC: Georgetown University Press.

Braithwaite, Jeffrey, Peter D. Hibbert, Adam Jaffe, Les White, Christopher T. Cowell, Mark F. Harris, William B. Runciman, et al. 2018. ‘Quality of Health Care for Children in Australia, 2012-2013’. JAMA 319 (11). American Medical Association: 1113–24. doi:10.1001/jama.2018.0162.

Cabana, Michael D., Cynthia S. Rand, Neil R. Powe, Albert W. Wu, Modena H. Wilson, Paul-André C. Abboud, and Haya R. Rubin. 1999. ‘Why Don’t Physicians Follow Clinical Practice Guidelines?: A Framework for Improvement’. JAMA 282 (15): 1458–65. doi:10.1001/jama.282.15.1458.

Carpenter, Morgan. 2018. ‘The “Normalisation” of Intersex Bodies and “Othering” of Intersex Identities’. In The Legal Status of Intersex Persons, edited by Jens Scherpe, Anatol Dutta, and Tobias Helms, 445–514. Cambridge, England: Intersentia. doi:10.1017/9781780687704.028.

Consortium on the Management of Disorders of Sex Development, California Endowment, Arcus Foundation, and Tides Foundation. 2006. Clinical Guidelines for the Management of Disorders of Sex Development in Childhood. Whitehouse Station, N.J.: Accord Alliance.

Cools, Martine, Anna Nordenström, Ralitsa Robeva, Joanne Hall, Puck Westerveld, Christa Flück, Birgit Köhler, et al. 2018. ‘Caring for Individuals with a Difference of Sex Development (DSD): A Consensus Statement’. Nature Reviews Endocrinology, May, 1. doi:10.1038/s41574-018-0010-8.

Earp, Brian D. 2017. ‘The Need for Reporting Negative Results – a 90 Year Update’. Journal of Clinical and Translational Research 3 (Suppl 2): 344–47.

Houk, C. P., I. A. Hughes, S. F. Ahmed, P. A. Lee, and Writing Committee for the International Intersex Consensus Conference Participants. 2006. ‘Summary of Consensus Statement on Intersex Disorders and Their Management’. PEDIATRICS 118 (2): 753–57. doi:10.1542/peds.2006-0737.

Hughes, I A, C Houk, S F Ahmed, P A Lee, and LWPES/ESPE Consensus Group. 2006. ‘Consensus Statement on Management of Intersex Disorders’. Archives of Disease in Childhood 91: 554–63. doi:10.1136/adc.2006.098319.

Intersex Human Rights Australia. 2018. ‘Submission to the Australian Human Rights Commission: Protecting the Human Rights of People Born with Variations in Sex Characteristics’. https://ihra.org.au/32490/ahrc-submission-2018/.

Lee, Peter A., Anna Nordenström, Christopher P. Houk, S. Faisal Ahmed, Richard Auchus, Arlene Baratz, Katharine Baratz Dalke, et al. 2016. ‘Global Disorders of Sex Development Update since 2006: Perceptions, Approach and Care’. Hormone Research in Paediatrics 85 (3): 158–180. doi:10.1159/000442975.

Millington, Sandra, Margaret Arstall, Gustaaf Dekker, Judith Magarey, and Robyn Clark. 2020. ‘Adherence to Clinical Practice Guidelines for South Australian Pregnant Women with Cardiac Conditions between 2003 and 2013’. PLOS ONE 15 (3). Public Library of Science: e0230459. doi:10.1371/journal.pone.0230459.

Mouriquand, Pierre D. E., Daniela Brindusa Gorduza, Claire-Lise Gay, Heino F. L. Meyer-Bahlburg, Linda Baker, Laurence S. Baskin, Claire Bouvattier, et al. 2016. ‘Surgery in Disorders of Sex Development (DSD) with a Gender Issue: If (Why), When, and How?’ Journal of Pediatric Urology. doi:10.1016/j.jpurol.2016.04.001.

Speiser, Phyllis W, Wiebke Arlt, Richard J Auchus, Laurence S Baskin, Gerard S Conway, Deborah P Merke, Heino F L Meyer-Bahlburg, et al. 2018. ‘Congenital Adrenal Hyperplasia Due to Steroid 21-Hydroxylase Deficiency: An Endocrine Society* Clinical Practice Guideline’. The Journal of Clinical Endocrinology & Metabolism 103 (11): 4043–88. doi:10.1210/jc.2018-01865.

Steele, Emma. 2019. ‘Emma Steele on Twitter: “Why Clinicians Don’t Follow Guidelines #GiantSteps19’. Twitter. November 22. https://twitter.com/emsteele1/status/1197623075061153792.

Woolf, Steven H, Richard Grol, Allen Hutchinson, Martin Eccles, and Jeremy Grimshaw. 1999. ‘Potential Benefits, Limitations, and Harms of Clinical Guidelines’. BMJ : British Medical Journal 318 (7182): 527–30.

Zillén, Kavot, Jameson Garland, and Santa Slokenberga. 2017. ‘The Rights of Children in Biomedicine: Challenges Posed by Scientific Advances and Uncertainties’. Committee on Bioethics of the Council of Europe.

This paper was written by Morgan Carpenter.

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