Consent Consensus: Time for a National Site-Specific Consent Form for Radiotherapy?

•There is currently no consensus in the prostate cancer radiotherapy consent process.•The Montgomery judgment has changed landscape for doctors taking consent.•Informed essential our patients.•A national standard form would legally put us a strong position. Informed (‘consent’) defined Cambridge English Dictionary as ‘agreement or permission to do something from someone who been given full information about possible effects results’. Clinical oncologists obtain regularly part of routine clinical practice, including when planning treatment with radiotherapy. Radiotherapy delivered either curative palliative intent comes risk serious adverse effects, both long and short term. This makes process particularly important. Ethically, we must take respect patient autonomy. Legally, performing procedure without criminal offence physician can be charged battery. The General Medical Council states: ‘you should not make assumptions might want need, other factors consider significant, patient's level knowledge understanding what proposed’ [[1]General Consent: patients decisions together.2008https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/consentDate accessed: April 21, 2020Google Scholar]. Deciding which side-effects discussed challenging. Physicians need aware their legal obligations. In England, law relating derived previous cases showing how requirements informed are interpreted applied by judges. Over time regarding developed. particular there have several high profile over last 20 years that significant bearing on consent. Historically, assessing whether doctor had discharged his duty properly inform all relevant before obtaining consent, test was familiar one applicable professional standards Bolam [[6]High Court Judgement vs Friern Hosptial Mangement Committee.1957Google A only show he acted accordance practice supported reasonable group responsible practising field. required provide additional risks response direct questioning. That significantly decision Supreme v. Lanarkshire Health Board, 2015 UKSC 11 [[2]Supreme Judgment board.2015https://www.supremecourt.uk/cases/docs/uksc-2013-0136-judgment.pdfDate court held that:The therefore under care ensure any material involved recommended treatment, alternative variant treatments. materiality whether, circumstances case, person position likely attach significance risk, reasonably it. emphasised importance dialogue identify specific material. an increasingly litigious society, obvious advantages having commonality forms processes. First, numerous individual centres creating forms, unnecessary wasteful duplication work. Second, real processes some will robust others. more lead unreliability Third, different use centres, identifying risks. case comprehensive may relied upon support claims against less detailed forms. Fourth, uniform documentation simplify training junior Fifth, approach avoid confusion between moving centres. Sixth, operating same system, using adopting similar approaches ‘dialogue’ patients, it easier peer review practicing very way. Seventh, where experience feedback and/or results revisions improvements process, those benefits rolled out underlying driver desire optimal patients. We cannot unless they provided options them together associated benefits. this way protect autonomy patient-centred care. conjunction Cancer Research UK, recently developed systemic anti-cancer therapy (SACT). They now widely used UK [[3]Cancer Systemic forms.2016https://www.cancerresearchuk.org/health-professional/treatment-and-other-post-diagnosis-issues/consent-forms-for-sact-systemic-anti-cancer-therapyDate Since judgment, Royal College Obstetricians Gynaecologists generated advisory procedures [[4]Royal Procedure advice.2009https://www.rcog.org.uk/en/guidelines-research-services/consent/Date shows feasibility site-specific were interested see if already across reviewed locally designed (SSPRT). As undergo following most protocols recent trials, side-effect similar. conducted survey listed Radiologists' website oncology trainees June September 2019. contacted radiographers asked e-mail SSPRT. 52 obtained 51. Twenty-seven (54%) SSPRT, remaining ‘consent 1’ online generic document. Northern Ireland North West form; others own received copies 22/27 Most (18/22) SSPRTs consented radical took targets: ten prostate, bed pelvic lymph nodes, four alone, two nodes pelvis, bed, fill procedure, cancer, bladder rectum bladder. Of analysed, 91% (20/22) set early late. analysed data separating late side-effects. If did differentiate included mentioned analysis both. All at least urinary bowel symptom side-effects, but emphasis different: 22% urgency, 40% haematuria, inflammation/cystitis 27% retention requiring catheterisation (Figure 1A). symptoms: 55% specifically frequency, 86% diarrhoea loose stool, 41% change flatulence/wind 36% bleeding movements general side-effects: 73% skin irritation hair loss area, 5% colour, 10% worsening haemorrhoids, 14% nausea It unclear why so different, perhaps reflects oncologist's personal experiences What found surprising lack potentially implications 1B). Only 77% infertility, 45% referred surgery damage incontinence. These which, line law, highlighted changes system function. However, 82% urethral narrowing. Our consistency Without unlikely uniformity ‘material’ each patient. Although every patient-specific, site experts, approved lawyers stronger ethically legally. Generating time-consuming centre. also save clinician's effort, spare litigation importantly making difficult time. Radiologists advertised fellow role help design publish template [[5]Royal Fellow: templates.2020https://www.rcr.ac.uk/college/getting-involved/rcr-clinical-fellows/clinical-fellow-national-radiotherapy-consentDate collaborative interacting lawyers, groups, professions, experts partnership specialty groups such British Urology Group Breast Group. long-term aim published website. authors declare conflict interest.