Commissioning Chemotherapy Services Conference Issues of consent in systemic therapy Dr Janine Mansi Consultant Medical Oncologist 28 th November 2017
Introduction Background and context What we have done What we have achieved to date Future plans
Background and Context Consent for majority of systemic therapy is mandatory Pharmacists and specialist nurses will not dispense or give treatment unless the consent form has been signed Historically (and in some cases currently) a standard consent form is used for this function
Standard Consent Forms Hand written! Variable side-effects included (or not) Quality dependent on clinician taking consent Can just write see patient information sheet No accurate or permanent record of what has been discussed
Standard Consent Form
Standard consent forms
Consent Consent is the principle that a person must give their permission before they receive any type of physical investigation, medical treatment, or personal care reflects the right of patients to determine what happens to their own bodies, and is a fundamental part of good practice. 1
Consent Issues Valid consent voluntary, informed, capacity Legal and ethical principles Procedural, NHS and organisational practice guidelines
The Law and Ethics The Bolam test (1957): If a doctor reaches the standard of a responsible body of medical opinion, he is not negligent
The Law and Ethics Montgomery Case 2015 Montgomery v Lanarkshire: a woman with diabetes and a small stature delivered her son vaginally; he experienced shoulder dystocia, resulting in hypoxic insult with consequent cerebral palsy
The Law and Ethics After the Montgomery case, the Bolam test, which asks whether a doctor s conduct would be supported by a responsible body of medical opinion, no longer applies to the issue of consent. The law now requires a doctor to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.
The Law and Ethics a patient should be told whatever they want to know, not what the doctor thinks they should be told the most important UK judgement on informed consent in 30 years supports patient autonomy over medical paternalism
Patients Clinical Concerns and Ethical Arguments more stringent disclosure requirements would risk overwhelming patients may cause distress may make poor decisions Doctors more lengthy explanations drain on healthcare resources defensive medicine
Clinical Concerns and Ethical Arguments The clinician s role is to ensure that relevant information is presented to enable the patient to use it meaningfully Today s patients can expect a more active and informed role in treatment decisions Legally, consent law has been clarified and aligns with current GMC guidance Ethically, it clarifies the existing shift towards a more cooperative approach in the consultation room» Chan et al, BMJ 2017;357:2224
Consent for SACT NCAG report 7 Recommendations relating to the whole of the chemotherapy pathway, including consent and information
Consent for SACT NCAG report Consent should be obtained and recorded in detail in terms of the aims of treatment and both the common and serious side effects of treatment Main proposed actions Standardised consent forms are used which include details of the toxicities discussed and which identify whether a patient has been provided with written information. Chemotherapy service providers should provide written information to patients about the chemotherapy they will be receiving, the likely side effects and whom they should contact if problems arise (including out of hours). Delivery of such information should be documented. A copy of the consent form should be given to the patient as well as one being filed in the patient s case record.
Consent for SACT Peer review Manual for Cancer Services: Chemotherapy Measures 2014 8
Consent forms at GSTT/SEL South East London supported project for development (AW) Guy s and St. Thomas NHS Foundation Trust (GSTT) developed a library of >250 chemotherapy regimenspecific consent forms in 2010-2012 Benefits High quality standardised information from clinician to patient Consistent, i.e. no omissions Tool for teaching and training
National project Practice of consent for SACT varies in the UK Cancer Research UK (CRUK) awarded a grant to GSTT to host the project Project to develop a national library of SACT regimen-specific consent forms commenced in October 2015 The UK Chemotherapy Board are the governing body for the project:
Created the webpage To host the forms and associated documents: www.cruk.org/sact_consent
Launch July 2016 Published and launched the guidance document First regimen-specific forms for breast cancer, and the generic form in July 2016 Emails to lead chemotherapy clinicians in the UK Communication to members of professional groups (ACP, RCP, RCR, RCPath, UKONS, BOPA) Cancer Research UK news report and tweets
National Guidance Recommends the use of regimen-specific forms Guidance for the introduction of the forms Guidance for the process of consent Audit recommendations
SACT regimen-specific forms By tumour group for oncology and haematology SACT regimens Reference to SPC, PIL, CRUK and Macmillan drug information sheets Each form is independently checked by an oncology/haematology pharmacist, oncology/haematology consultant and member of the UK Chemotherapy Board
5-page form Standard template National Forms
Page 1 Hospital name Health professional details Patient details Regimen details Where treatment will be given The intended benefits
Page 2 Regimen-specific risks and side effects Separated into common, occasional and rare and other issues Includes a statement that the treatment may be life threatening or even result in death
Page 3 Space for other risks Statements confirming discussions Details of leaflets provided Clinician signature Interpreter signature (where appropriate)
Page 4 Patient statement and confirmation of consent Further information for patients Whether copy accepted by patient or not
Page 5 Guidance for health professionals
Published forms Breast July 2016 Generic July 2016 Head and neck cancers October 2016 Melanoma November 2016 Generic immunotherapy December 2016 Gynaecological cancers January 2017 Lung cancers March 2017 Supportive medicines April 2017 Colorectal cancer May 2017 Urology/Bladder cancer July 2017 Thyroid cancer September 2017 Oesophago-gastric and GIST October 2017
Communication and Queries Communication Email updates when new forms published Emails to lead chemotherapy clinicians in the UK, UK Chemotherapy Board members, and project mailing list Queries Database of all user queries and our responses FAQ document published October 2016 Used to inform development of forms and project
Number of visits Evaluation Website analytics (1) 3000 Visits to consent form page by Country 2500 2000 1500 1000 500 UK England N. Ireland Scotland Wales Unknown Other 0 Aug-16 Sep-16 Oct-16 Nov-16 Dec-16 Jan-17 Feb-17 Mar-17 Apr-17 May-17 Jun-17 Jul-17 Aug-17 Sep-17 Month
Number of Downloads Evaluation Website analytics (2) 2500 2000 Downloads from consent form webpage (www.cruk.org/sact_consent) Guidance document Generic SACT form Generic immunotherapy form FAQ document Breast forms Head & neck forms 1500 1000 Melanoma forms Gynaecological cancer forms CML forms Lung forms 500 0 Supportive medicines forms Colorectal forms Urology forms Thyroid forms Month Total
January 2017: Evaluation Survey (1) Aims and objectives To evaluate the uptake of the national forms in England, N. Ireland, Scotland and Wales To obtain feedback on the forms To obtain feedback on the challenges related to introducing the forms To use feedback to inform future developments of the project
Evaluation Survey (2) Method Survey built using SurveyMonkey, piloted and emailed to lead chemotherapy clinicians within NHS hospitals/trusts in the UK in January 2017 Results analysed after 2 weeks Results 87 responses 87% of responses from hospitals/trusts in England 92% aware of national consent forms 74% aware of guidance on consent for SACT
Response percent % Evaluation Survey (3) Results (cont.) 50 Method used to consent adult patients to treatment with SACT in the hospital/trust 45 40 35 30 25 20 15 Prior to launch of national forms Following launch of national forms 10 5 0 Dept. of Health consent form 1 Local hospital/trust standard consent form Locally developed generic SACT consent form Locally developed SACT regimenspecific consent forms National generic SACT consent form National SACT regimen-specific consent forms
Evaluation Survey (4) Results (cont ) 30 hospitals/trusts using forms; 17 plan to use Reasons for not using forms included: o Prefer existing method o Forms not approved in hospital/trust o Resistance from key stakeholders o Too much paper to give to patients o Time and motivation to implement o Use of electronic systems and processes o Forms not available for all tumour groups o Awaiting regional steer on use of national forms o Queries regarding legality of forms
Evaluation Survey (5) Conclusions Results give an indication of the awareness and uptake of forms Responses give insight into the benefits and challenges of using the forms Comments positive overall Constructive feedback
Evaluation Survey (6) Recommendations Continue to publish forms Outline options for local processes Issue reminder regards national guidance document Continue to send regular updates and comms Legal review of the forms Develop and publish paediatric forms Scope feasibility of electronic forms Repeat survey in 1 year
Iterative process Responding to comments Hearing about other practices Extravasation Peripheral neuropathy Haemato-oncology
Next steps Forms for the remaining tumour groups will be published in 2017-2018 A national steering group is being set up Project evaluation repeat survey Jan/Feb 18 Year 3 Continued maintenance and update of form library Paediatric, TYA and Sarcoma Scope electronic forms Welsh translation of generic forms
References Reference guide to consent for examination or treatment: Second edition, Department of Health, 2009. Consent: patients and doctors making decisions together, General Medical Council, 2008. Sokol D. Update on the UK law on consent. BMJ 2015; 350:h1481. Guidance on consent, General Pharmaceutical Council, 2012. The code for nurses and midwives, Nursing and Midwifery Council, 2015. Health and Social Care Act 2008 (Regulated Activities) Regulations Care Quality Commission, 2014. Chemotherapy Services in England: Ensuring quality and safety, National Chemotherapy Advisory Group, August 2009. Manual for Cancer Services Chemotherapy Measures: Version 1.0, National Peer Review Programme, NHS England, April 2014. Consent form 1, Department of Health, 2009.
Acknowledgements: Acknowledgements Rena Chauhan highly specialist pharmacist Victoria Fashina highly specialist pharmacist (June 2017) Jacky Turner previous lead pharmacist (to 2015) Nisha Shaunak Lead Oncology Pharmacist and Specialised Cancer Commissioning Pharmacist, NHS England (London region) Colleagues at GSTT and Cancer Research UK Members of the UK Chemotherapy Board Tumour specific leads from the CSGs who will help drive the project forward (Steering Group)