1. Aintree Head & Neck Unit Practice Development Unit Research into practice

2. What is a PDU? Practice Development Units (PDUs) seek the development and sharing of best practice; interdisciplinary team working / learning and give a framework to guide and support development activity within the unit to ultimately improve the care given to patients. PDUs seek excellence, questioning current practice and challenging practitioners to develop services and the current supporting evidence base: www.bournemouth.ac.uk/cfpd/pdf/practice-development-unit-accreditation.pdf

3. Why do we want to be a PDU?? University accredited award of our progress and status. Increase morale. Promotion of best practice and safety for the patient.

4. Who is the PDU? Everyone! Nursing Staff Medical Staff Patients Physiotherapi sts Speech Therapists Dental Hygienists DieticianClinic Staff Clerical / Admin Management Occupational Therapy Academic Institutions Audiology Clinical Trials/ Research

5. So what is involved? 1.Edge Hill 7 standards for PDU re- accreditation. 2.12 – 18 month preparation. 3.Collaborative teamwork. 4.Inclusivity

6. Online Access & Submission

7. Edge Hill PDU Standards 1. Multiprofessional collaboration and communication. 2. Evidence based practice. 3. Research. 4. Improving patient safety 5. Staff development. 6. Patient & public involvement. 7. Academic links.

9. Edge Hill PDU Standards 1. Multiprofessional collaboration and communication. 2. Evidence based practice. 3. Research. 4. Improving patient safety 5. Staff development. 6. Patient & public involvement. 7. Academic links.

11. Edge Hill PDU Standards 1. Multiprofessional collaboration and communication. 2. Evidence based practice. 3. Research. 4. Improving patient safety. 5. Staff development. 6. Patient and public involvement. 7. Academic links.

12. Head and Neck Airways Group

13. Head & Neck Airways Group

14. Edge Hill PDU Standards 1. Multiprofessional collaboration and communication. 2. Evidence based practice. 3. Research. 4. Improving patient safety. 5. Leadership & staff development. 6. Patient and public involvement. 7. Academic links.

15. Leadership and Staff Development Lunchtime Seminars

16. Leadership and Staff Development Evaluation forms

17. Edge Hill PDU Standards 1. Multiprofessional collaboration and communication. 2. Evidence based practice. 3. Research. 4. Improving patient safety. 5. Leadership & staff development. 6. Patient and public involvement. 7. Academic links.

18. Hot Topics Group

19. Edge Hill Standards 1. Multiprofessional collaboration and communication. 2. Evidence based practice. 3. Research. 4. Improving patient safety. 5. Leadership & staff development. 6. Patient and public involvement. 7. Academic links.

20. Research Standard Criteria Reference material and documentation is accessible and available within the unit. Staff are encouraged to undertake research training and development Individual and collaborative research projects are in progress within the unit.

21. Research 3.1

22. Research Standard Criteria Reference material and documentation is accessible and available within the unit. Staff are encouraged to undertake research training and development Individual and collaborative research projects are in progress within the unit.

23. How do I register for Athens?

24. Click on the NHS Evidence logo

25. Research Standard Criteria Reference material and documentation is accessible and available within the unit. Staff are encouraged to undertake research training and development Individual and collaborative research projects are in progress within the unit. We’ll come back to this!!

26. Research Standard Criteria Completed local research reports, individual and collaborative, are available within the unit. Staff demonstrate an awareness of up to date evidence/research pertinent to their practice. Research findings are disseminated in the unit and within the Trust.

27. Publication Database

28. Research Standard Criteria Completed local research reports, individual and collaborative, are available within the unit. Staff demonstrate an awareness of up to date evidence/research pertinent to their practice. HOT TOPICS Research findings are disseminated in the unit and within the Trust.

29. Research Standard Criteria Completed local research reports, individual and collaborative, are available within the unit. Staff demonstrate an awareness of up to date evidence/research pertinent to their practice. HOT TOPICS Research findings are disseminated in the unit and within the Trust.

30. Lunchtime Seminars AHNOG The Aintree head and neck oncology meeting(AHNOG) meets annually. The day involves presentations on the unit’s research activity, service provision, research projects presented by external speakers as well as other relevant topics to the head and neck oncology field.

31. AHNOG

32. Research in the NHS – is it a luxury?’ Professor T. Jones. Trust Grand Round

33. Research Standard Criteria Research findings are disseminated within the National and International health and social care arena. Articles prepared and submitted to professional journals whilst the unit is working towards PDU accreditation.

35. Research Standards Criteria Research findings are disseminated within the National and International health and social care arena. Articles prepared and submitted to professional journals whilst the unit is working towards PDU accreditation. Website Database

36. Patient & Public Involvement User and carer groups are actively involved in developments within the Unit The views of users and/or carers are sought in the planning, implementation, delivery and evaluation of care.

37. Patient Research Forum

38. Introduction. PRF beginnings. Why PRF? A typical meeting? Roles of the PRF -

39. Research into Practice Audiology Chemotherapy Ototoxicity Project

40. Why/Idea? Audiology provides both diagnostic and rehabilitation services for patients with hearing problems, balance disorders and tinnitus During routine clinics we found that we were seeing a number of patients referred via their GPs with hearing loss and tinnitus following chemo-radiation therapy (CRT) for head and neck cancer

41. Why/Idea? In many instances the patients had reached a stage were the hearing loss, balance problem or tinnitus was severely debilitating Hearing loss caused isolation from family and friends Tinnitus was causing anxiety and depression Many patients had the added distress of poor speech following surgery which added to their distress and isolation

42. Service evaluation We decided that we wished all patients to be offered a hearing, tinnitus and balance assessment at clinic following treatment with CRT in order to identify problems and assist with rehabilitation and coping strategies from an early stage

43. Practice development As part of the Head & Neck Practice Development Unit we looked into performing some collaborative work in order to improve the quality of life for this patient group With the help of the PDU, Consultants and specialist nurses we hope to offer all ENT Oncology patients a hearing assessment following treatment with chemoradiation

44. Service Evaluation Initial trial is for one ENT consultant to refer all patients who are being treated with chemoradiation for a hearing assessment, before and after treatment. Currently we do not know how many patients treated annually with chemoradiation Following on from the service evaluation we are in the process of seeking ethical approval for a research project

45. Research 50% of patients treated with CRT develop hearing loss – we wanted to know the figure amongst our local population Not a lot of research has been completed regarding the effects of treatment on tinnitus development and its impact As we have a well established and successful tinnitus service we wanted to develop advice and treatments at an early stage to improve the patients QoL

46. Decision to treat with chemo/radiation made at clinic within multidisciplinary team. Inclusion / exclusion criteria – Patients over the age of 16 treated for Head and Neck cancer with review appointments at UHA who have not received previous chemotherapy Consultation with consultant for treatment plan

47. New patient who has no previous history of head and neck cancer is approached as part of the Head & Neck 5000 Cohort study and given written information regarding the chemotherapy and its effects on the hearing and balance system Patients with previous Head & Neck cancer and not eligible for Head & Neck 5000 are approached by the Clinical Nurse specialist with verbal and written information about the chemotherapy study.

48. Patients asked if they are happy to receive a follow up phone call from a member of the Audiology department within the next 3-7 days. Within 7 days Tony Kay or Gaynor Chittick will contact the patient via telephone to confirm whether they wish to be part of this study and have an Audiological assessment. This will include questions regarding eligibility and be an opportunity for the patient to ask any questions regarding the study.

49. An appointment will be made at a mutually convenient time for the patient to attend the Audiology assessment. Patients will verbally agree to be part of this study at this time. Payment for transport and hospital parking will be met.

50. Patient completes chemoradiotherapy. At approximately 6-12 weeks after completion of their treatment they attend their routine Head & Neck Oncology review appointment and will be retested in the Audiology clinic. Any patients who previously declined to take part in the study will be asked if they have noticed any change in their hearing/balance or tinnitus and will be offered an Audiological assessment. Those patients who are found to have any change or deficits in their hearing/tinnitus or balance will be offered treatment as per standard treatment protocols.

51. Ethical issues : 1. If a patient has deafness or tinnitus at their baseline assessment should we advise that this may get worse following treatment with the possibility that they decide against chemotherapy. 2. Unilateral hearing loss – at what stage should we screen for AN. In view of the fact that AN are usually very slow growing. 3. Patient has significant tinnitus at baseline assessment. This could increase in loudness and intensity following chemotherapy and therefore patient would need to consider survival of cancer with possible long term tinnitus.

52. All patients are to be offered a hearing test pre and post treatment whilst in the clinic at the stage of referral for chemo/radiotherapy and then again at their 6/52 review. All patients will be offered the test whilst they are attending the clinic appointment to avoid unnecessary journeys to hospital and their time in clinic should hopefully not be extended significantly. An information leaflet will be given to each patient explaining the possible change in hearing following treatment. Referrals for Audiology assessment will be completed by the specialist nurses, the head and neck surgeons and oncologists. As with all hearing tests and Audiological examinations other underlying pathologies may be discovered which may require intervention and further investigation.

53. A10. What is the principal research question/objective? Please put this in language comprehensible to a lay person. To identify the incidence of hearing loss and tinnitus post chemo/radiotherapy treatment in patients with head and neck cancer who are treated at Aintree NHS Trust A11. What are the secondary research questions/objectives if applicable? Please put this in language comprehensible to a lay person The secondary research objective is to identify information that may be used to assist future decision-making by patients and clinicians in new cases. We hope to role out the findings of this study in order to offer appropriate counselling and treatment to all patients attending for chemo/radiotherapy so that early treatments and rehabilitation can be introduced..

54. A12. What is the scientific justification for the research? Please put this in language comprehensible to a lay person. Chemo and radiotherapy are known to be ototoxic and cause damage to the inner ear. We wish to identify this hearing loss and/or tinnitus at an early stage in order to offer amplification devices or rehabilitation in the form of tinnitus management.

55. Patient Concerns Inventory Barry Scott Clinical Specialist Physiotherapist Head & Neck Cancer Services Aintree University Hospitals NHS Foundation Trust ENT UK / BAOMS Meeting Thursday 8 th September 2011

56. The PCI is a system developed to allow patients to identify issues they wish to discuss as part of their consultation Also allows patients to identify members of the MDT they wish to see as part of their consultation Uses touch screen computer in the clinic setting A way to recognise unmet needs What is the PCI ?

57. How does it work ?

58. Patient Concerns Inventory : Issues they wish to discuss 55 items

59. Patients Concerns Inventory PCI : Professions they wish to see / be referred to

60. Patient Concerns Inventory : Issues they wish to discuss Rogers SN, El-Sheikha J, Lowe D. The development of a Patients Concerns Inventory (PCI) to help reveal patients concerns in the head and neck clinic. Oral Oncol. 2009; 45: 555-561.

61. The median number of issues: 3 IQR 1-6 82% selecting at least 1 issue Patient Concerns Inventory : Issues they wish to discuss

62. Patients wished to talk with either in clinic or by referral dentist (19%) surgeon (10%) speech and language therapist (10%) Range 0 to 8 with 42% selecting at least one PCI: MDT results

63. Patient Concerns Inventory : Clinical research Patient experience Relevant research Improved services / care

64. Published PCI Literature

65. ‘Best use of IT in patient and citizen involvement in healthcare’ Winner National Winner National E-Health Insider Awards 2010

66. Letter to GP and MDT Members

67. www.headandneckcancer.co.uk PCI available via the website

68. Clinical Trials What are Clinical Trials?

70. February 2011Head and Neck Oncology Clinical Trials Team Head and Neck Oncology Clinical Trials

71. February 2011Head and Neck Oncology Clinical Trials Team Areas to be covered (1)What are clinical trials? (2)Clinical trials open at Aintree? (3)Eligibility for clinical trials? (4)Safety! (5)Barriers to recruitment?

72. February 2011Head and Neck Oncology Clinical Trials Team What are Clinical Trials? ‘Clinical Trials’ are generally: “biomedical or health- related research studies in human beings that follow a pre-defined protocol”. Video! http://www.headandneckcancer.co.uk/Research/Clinical+Trials/What+are+clinical+trials.aspx

73. February 2011Head and Neck Oncology Clinical Trials Team Medical research studies involving people are called clinical trials. Clinical trials in cancer look at: (1)Risks and causes - how genetics, lifestyle and other factors can increase people's risk of cancer. (2)Preventing cancer - using drugs, vitamins or diet to reduce risk. (3)Screening - for people at higher than average risk, or for the general population. (4)Diagnosing cancer - new tests or scans. (5)Treatments - new drugs or combinations of drugs, new ways of giving treatment, and new types of treatment. (6)Controlling symptoms or side effects - new drugs or complementary therapies.

74. February 2011Head and Neck Oncology Clinical Trials Team Trials aim to find out if a new treatment or procedure: (1)Is safe! (2)Has side effects! (3)Works better than the currently used treatment! (4)Helps you feel better!

75. February 2011Head and Neck Oncology Clinical Trials Team There are 4 phases of clinical trials: Phase 1 trials look at whether a trial treatment is safe or has any harmful effects - the research team will also find out the best dose to use. Phase 2 trials look at how well a treatment works - only treatments that have got through these 2 phases go into phase 3 testing. Phase 3 trials test a new treatment against the existing standard treatment - if it gives better results, it may become the new standard treatment. Phase 4 trials are carried out after a drug has been licensed - they collect information about side effects, safety and the long term risks and benefits of a drug

76. February 2011Head and Neck Oncology Clinical Trials Team Benefits: (1)Clinical trials that are well-designed and well-executed are the best approach for eligible participants to: Play an active role in their own health care. (2)Gain access to new research treatments before they are widely available. (3)Obtain expert medical care at leading health care facilities during the trial. (4) Help others by contributing to medical research.

77. February 2011Head and Neck Oncology Clinical Trials Team Risks: (1)There may be unpleasant, serious or even life-threatening side effects to experimental treatment. (2)The experimental treatment may not be effective for the participant. (3)The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

78. February 2011Head and Neck Oncology Clinical Trials Team Open Clinical Trials Cohort Studies at Aintree. (1)Pet Neck (2)HOPON (3)SEND (4)Dete QT (5) Head and Neck 5000 (6) Titan (7) LIHNCS (8) Realistic

79. February 2011Head and Neck Oncology Clinical Trials Team Pet Neck: ‘Is a randomised research project comparing two methods for managing head and neck cancers for patients with cancer which has spread into the neck glands’. Arm 1 is a monitoring policy using PET-CT scanning after chemo- radiotherapy. Arm 2 is the standard method, which is surgical removal of neck glands followed by chemo-radiotherapy. 7 patients currently on trial.

80. February 2011Head and Neck Oncology Clinical Trials Team HOPON: This study has been designed to assess whether pre treatment Hyperbaric Oxygen therapy is beneficial in the prevention of ORN for patients who have had radiotherapy and now require minor mandibular (Dental / Implants) surgery. This trial is to find whether there is any difference between two different types of treatment. 1.Surgery with antiseptic mouthwash and antibiotics. 2.Pre treatment HBO then surgery with antiseptic mouthwash and antibiotics. 38 patients currently on trial

81. February 2011Head and Neck Oncology Clinical Trials Team

82. February 2011Head and Neck Oncology Clinical Trials Team SEND: (1)To determine whether the use of a selective neck dissection (SEND) used electively on all patients presenting with stage I-II oral cavity squamous cell carcinoma (SCC) improves survival, disease-free survival, and loco-regional disease control rates. (2)To determine how SEND and complex reconstruction affect quality of life and mental health. (3)To determine whether the use of SEND on all patients presenting with stage I-II oral cavity SCC represents a cost-effective use of resources

83. February 2011Head and Neck Oncology Clinical Trials Team SEND: Arm I: Patients undergo resection of the primary tumour with neck dissection. Arm II: Patients undergo resection of the primary tumour alone. Patients in both Arms complete quality of life and health service use questionnaires up to 2 monthly following surgery. After surgery, patients are followed periodically for up to 5 years. 24 patients currently on trial.

84. February 2011Head and Neck Oncology Clinical Trials Team Head & Neck 5000 – The aim of the research is to look at care for people with head and neck cancer. This will be the largest study to examine the factors that affect outcome for people with head and neck cancer.

85. TITAN address the potential survival advantage of TPF induction chemotherapy prior to surgery and radiotherapy for locally advanced resectable SCCHN. REALISTIC - A phase (i) dose escalation trial of recombinant listeria monocytogenes (Lm)-based vaccine encoding human papilloma virus serotype 16 target antigens (ADXS11-001) in patients with HPV-16 +ve oropharyngeal carcinoma February 2011Head and Neck Oncology Clinical Trials Team

86. February 2011Head and Neck Oncology Clinical Trials Team Safety! “The health of my patient will be my first consideration” World Medical Assembly Clinical research / trials are regulated with built in safeguards to protect the participants. The trials follow carefully controlled protocols. The protocol will have been passed by the local research ethics committee and rigorously checked by the R&D department at the centre / hospital wishing to open the trial for recruitment

87. February 2011Head and Neck Oncology Clinical Trials Team Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. “The health of my patient will be my first consideration” World Medical Assembly

88. February 2011Head and Neck Oncology Clinical Trials Team Safety! Safety: Once recruited safety is maintained by; (a) Close follow-up protocols (b) Documented information in the case notes about the trial in question (c) Contact details for the research practitioners available in the health care records.

89. February 2011Head and Neck Oncology Clinical Trials Team Barriers to recruitment! 1.Communication / Staff Awareness. 2.Regional Aspect of service. 3.Community Awareness (increased possible participant knowledge). 4.Treatment plans.

91. Summary! 1. Head and Neck Practice Development Unit has a large research portfolio. 2. H&N PDU Collaborative teamwork not only works but delivers results. 3.The outcomes of Aintree’s research (Research into practice) are affecting patient’s experience and treatment options – both now and in the long term.

92. Questions? www.headandneckcancer.co.ukwww.headandneckcancer.co.uk.