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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.
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?
• Do all patients with retrosternal goitre require surgery?
• Radioiodine or surgery for patients with thyrotoxicosis?
• The extent of surgery for differentiated thyroid cancer?
• Prophylactic lymph node dissection in papillary thyroid cancer?
• The extent of lymph node surgery in medullary thyroid cancer?
• When to complete primary surgery/re-operate in patients with medullary thyroid cancer?
• The indications for surgery in patients with mild hypercalcaemia?
• What are the indications for re-operative parathyroid surgery?
• Which imaging studies are appropriate prior to re-operative surgery?
• Transperitoneal or retroperitoneal laparoscopic surgery?
• Open or laparoscopic surgery in patients with Stage 1 or 2 adrenocortical cancer?
• What size of incidentaloma should be removed?
• Which preoperative localisation/regionalisation studies are required in patients with insulinoma/gastrinoma?
• When to operate on the pancreas and the extent of surgery in patients with multiple endocrine neoplasia type 1 (MEN1)?
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 cancer6–8), 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.
What is good practice?
• Which biochemical/cytological tests and imaging studies are necessary prior to surgery, and will their results alter the management of the patient?
• Is an operation required? What is the purpose and aim of the procedure? How will this benefit the patient?
• Which operation is appropriate in this specific case?
• Does the patient understand the indications, implications and risks of surgery in order to give informed consent?
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 advantages of subspecialisation
It is all too easy to lose sight of the important issues:
• one or more surgeons with a declared interest in endocrine surgery;
• an annual operative workload in excess of 50 cases (verified by BAETS audit);
• on-site cytology and histopathology services;
• at least one consultant endocrinologist on site, holding one or more dedicated endocrinology clinics per week, with joint clinics or formal meetings held not less than once per month;
• a Department of Nuclear Medicine on site;
• on-site magnetic resonance imaging (MRI) and computed tomography (CT) scanning.
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.16–20 This is also true for paediatric endocrine surgery.21,22 Supervised trainees and newly established endocrine surgeons can perform thyroid surgery safely.23–25
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.26–29 MTC is rare; all patients should be referred for surgical treatment to a cancer centre.
3. As the quality of the care received by the patient is paramount it should be subject to assessment by audit and benchmarking against agreed standards.
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
• 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.
Outcome measures: There should be documented evidence to support that:
• The patient was informed of the indications for surgery and its risks and complications.
• FNAC was performed in at least 90% of patients prior to operation for solitary/dominant nodule.
• The recurrent laryngeal nerve(s) were identified during a surgical procedure.
• The permanent postoperative vocal cord palsy rate is not more than 1%.
• All patients scheduled for re-operative thyroid surgery have undergone preoperative examination of their vocal cords.
• The re-operation rate for postoperative haemorrhage after thyroidectomy is less than 5%.
• Patients with thyroid malignancy have been reviewed by the specialist multidisciplinary team.
Parathyroid surgery
Standards: In patients who undergo first-time operation for primary hyperparathyroidism:
• The indications for operation, risks and complications should be discussed with patients prior to surgery.
• The surgeon should identify and cure the cause of the disease in at least 95% of cases.
• All patients reporting voice change after parathyroid surgery should undergo examination of their vocal cords. Permanent vocal cord palsy should not occur in more than 1% of patients.
• All patients scheduled for re-operative parathyroid surgery should undergo preoperative examination of their vocal cords.
• Permanent hypocalcaemia should not occur in more than 5% of patients.
Outcome measures: There should be documented evidence to support that:
• The patient was informed of the indications for surgery and its risks and complications.
• After first-time parathyroid surgery, at least 90% of patients are normocalcaemic without calcium or vitamin D supplements.
• The permanent postoperative vocal cord palsy rate is not more than 1%.
• All patients scheduled for re-operative parathyroid surgery have undergone preoperative examination of their vocal cords.
Adrenal surgery
Standards: There should be multidisciplinary working to agreed diagnostic and therapeutic protocols to ensure that an appropriate strategy is developed for patients. This should include the management of the preoperative, perioperative and postoperative metabolic syndrome.
Pancreatic surgery
• There should be multidisciplinary working to agreed diagnostic and therapeutic protocols to ensure that an appropriate strategy is developed for patients. This should include management of the preoperative, perioperative and postoperative metabolic syndrome.
• Patients with familial endocrine disease should be identified prior to surgery.
• The aims of any surgical procedure must be clearly defined prior to surgery.