Clinical governance, ethics and medicolegal aspects of endocrine surgery

Published on 28/03/2015 by admin

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Clinical governance, ethics and medicolegal aspects of endocrine surgery

Clinical governance

We are in the third health revolution. The first was the arrival of technology to improve care, the second the impact of financial constraints and the third the era of accountability.1 The measurement and regulation of clinical activity is here to stay.

The key points of clinical governance are to improve clinical care, avoid risk and detect adverse events rapidly. We can influence these by continued professional development, quality improvement, risk management and clinical effectiveness.

There is ample evidence that doctors left to their own devices are not as effective as they would like to think they are, and never have been. Most surgeons would agree that unacceptable variations in standards of care and outcomes must be made to disappear yet, despite good intentions, therapeutic activity that is ineffective or unsubstantiated may take many years to disappear from clinical practice. In addition, our individual practice and the interventions that we use inevitably reflect the current fashion, sometimes in the absence of any evidence base. In contrast, we should not lose sight of the fact that the ‘evidence base’ and systematic reviews may be adversely affected by subjective analysis, interpretations of variations in the results from previous studies, publication bias and missing data. In ideal circumstances, from an idea and hypothesis that leads to technical advances in surgery there should be systematic progression that ends in the development and assessment of appropriate outcome measures.2 This certainly applies to the development of minimally invasive surgery of the thyroid and parathyroid glands.3 Are mortality and readmission rates, complications and duration of hospital stay sufficient to show that the new is an improvement on what has gone before?

Examination of new and old controversies in endocrine surgery as shown below tells us that there is currently little evidence to support a rigid approach to how we advise our patients. For example:

Thyroid disease

Parathyroid

Adrenal

Pancreas

In endocrine surgery there will never be evidence based on prospective randomised controlled trials to support much of what we do, yet should we practise our craft in the manner that our peers have demonstrated to be the most effective? Critical review of our current practice will benefit our patients prior to, during and after surgery.

Various international guidelines, consensus/positional statements are available to guide good practice in the investigation and surgical treatment of adult and paediatric4 thyroid (thyrotoxicosis,5 benign nodules, differentiated and medullary thyroid cancer68), parathyroid (hyperparathyroidism9,10) and adrenal (incidentaloma,11 malignant tumours12) disease.

Guidelines should help us make decisions about what is appropriate and, in association with a review of whatever evidence there is, lead to change and improvement in patient care. It should be remembered that guidelines are ‘explicit’ information that helps us to make decisions, but the art of medicine needs as much ‘tacit’ as ‘explicit’ input.13 Written statements describing the rules, actions and conditions that direct patient care can be considered as a medical definition of standards of care.

For the moment we need to stick to guidelines while remembering that they should be part of an iterative process of regular criticism and review, and that they will often need to be adapted to local circumstances. They should ideally be constructed to avoid a dogmatic approach as to what are ‘appropriate’ treatments.

Who should perform surgery on the endocrine glands?

The 1996 consensus statement on thyroid disease by the Royal College of Physicians of London and Society of Endocrinology14 stated: ‘each District General Hospital should have access to an experienced thyroid surgeon’. Although surgery of the endocrine glands is currently the scene of dispute between general surgeons (endocrine/upper gastrointestinal/hepatobiliary), head and neck, oromaxillofacial, ENT surgeons and urologists, no individual group has an unassailable right to care for and treat the patients. The needs of the patient must come first. The introduction to the British Association of Endocrine and Thyroid Surgeons (BAETS) guidelines15 states:

“[the guidelines do] not define an endocrine surgeon or specify who should practice endocrine surgery … Elective endocrine surgery will not be in the portfolio of every District General Hospital, but where it is, based on experience and caseload, it should be in the hands of a nominated surgeon with an endocrine interest. Those patients requiring more complex investigation and care as detailed in the guidelines should be referred to an appropriate centre. These rare and complex diseases will only be managed effectively by multidisciplinary teams in Units familiar with these disorders … this category includes patients with endocrine pancreatic tumours, adrenal tumours, thyroid malignancy especially medullary thyroid carcinoma, familial syndromes and those requiring reoperative thyroid and parathyroid surgery.”

The advantages of subspecialisation

It is all too easy to lose sight of the important issues:

In the UK, the higher surgical trainee who declares an interest in endocrine surgery should spend at least 1 year in an approved unit, which should consist of:

In practical terms flexible rotations between regions may be required for more specialised areas of endocrine practice, such as adrenal surgery.

The current syllabus (www.iscp.ac.uk/documents/syllabus_GS_2010.pdf) and subspecialist curriculum (www.baes.info/Pages/BAETS%20Guidelines.pdf) for endocrine surgical training in the UK are well defined. Examples of how endocrine surgical operative experience and competence for an individual trainee can be identified and rated (www.nthst.org.uk/Assets/Files/RITA_forms/NTHST_OpComp_Endocrine_v_1.doc) are available, and in future will help define what constitutes ‘appropriately trained’.

Complication rates following thyroid, parathyroid and adrenal procedures are higher in patients treated by non-specialists, and lower when ‘high-volume’ surgeons operate or patients are treated in high-volume centres.1620 This is also true for paediatric endocrine surgery.21,22 Supervised trainees and newly established endocrine surgeons can perform thyroid surgery safely.2325

The care of patients with thyroid cancer should be the responsibility of a specialist multidisciplinary team (MDT) that comprises surgeon(s), endocrinologist and oncologist (or nuclear medicine physician) with support from pathologist, medical physicist, biochemist, radiologist and clinical nurse specialist. All should have expertise and interest in the management of thyroid cancers and show commitment to continuing education in the field.

There is evidence from the UK and the USA to support a continued need for subspecialisation in endocrine surgery and adherence to good practice, e.g. total thyroidectomy and lymph node dissection is the standard of care in patients with medullary thyroid cancer (MTC) yet 10–15% of patients with MTC undergo less than total thyroidectomy and 30–40% of patients have no cervical node dissection.2629 MTC is rare; all patients should be referred for surgical treatment to a cancer centre.

In 1998, a retrospective study from a single district hospital identified that only 42% of patients with thyroid cancer presenting with a thyroid nodule had preoperative fine-needle aspiration cytology (FNAC).30 In contrast, BAETS audit data from 2009 reported that 82% of treated patients, confirmed at histology to have a neoplastic lesion, underwent fine-needle aspiration (FNA) prior to the operation.29 The collection of such prospective information on endocrine surgical activity in the UK is crucial, not only for issues of surgical subspecialisation but for education and training. For UK surgeons, continuing full membership of the BAETS is conditional upon the submission of their clinical activity to the audit. It is likely in the future that General Medical Council (GMC) revalidation will require confirmation that surgeons take part in comparative national audit. The following standards and outcome measures are suggested as being applicable to current endocrine surgical practice.

Thyroid surgery

Standards:

• The indications for operation, risks and complications should be discussed with patients prior to surgery.

• FNAC should be performed routinely in the investigation of solitary thyroid nodules.

• The recurrent laryngeal nerve should be routinely identified in patients undergoing thyroid surgery.

• All patients scheduled for re-operative thyroid surgery should undergo preoperative examination of their vocal cords by an ENT surgeon. All patients reporting voice change after thyroid surgery should undergo examination of their vocal cords. Permanent vocal cord palsy should not occur in more than 1% of patients.

• A return to theatre to control postoperative haemorrhage should occur in less than 5% of patients.

• All patients with thyroid cancer should be reviewed by the Cancer Centre designated specialist multidisciplinary team.

Parathyroid surgery

Pancreatic surgery