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Development of a financially viable model for the outpatient management of mandibular fractures in a Level 1 Major Trauma Centre
Abstracts / British Journal of Oral and Maxillofacial Surgery 52 (2014) e43–e74
nificant (p<0.001) at determining outcome, and was hence likely to be useful. http://dx.doi.org/10.1016/j.bjoms.2014.07.069 64 Successful Recruitment to Head & Neck Trials: lessons learned from the LIHNCS Trial James McCaul ∗ , James Cymerman, Raghav Kulkarni, Kayleigh Gilbert, Amy Pendrill, Jacquelline Quantrill, Janet Dunn BRI/Bradford Institute for Health Research Background: Recruitment to the Lugol’s Iodine in Head and Neck Cancer Surgery (LIHNCS) trial is now complete. This is the largest and fastest recruiting head and neck surgical oncology trial in the UK, and will be delivered on schedule. Invaluable lessons have been learned throughout the process, which we wish to share to ensure continued surgical research success. Methods: The LIHNCS team developed number of strategies to overcome challenges faced in recruitment of patients into a surgical trial. These include: • Good Clinical Practice training specific to surgeons (a de novo course developed by the Chief Investigator Professor McCaul). • Attainment of Portfolio status - to aid recognition, funding and appropriate staffing. • Site initiation visits in person from members of the research team rather than via a teleconference call. • Close monitoring of recruitment figures per site per month to recognise any sites that may be struggling with recruitment. • Named surgeon certificates rewarding increasing levels of patient recruitment. A research specific document for personal portfolios. • Continuous exposure of the trial at national and international meetings. Acknowledging recruiting sites and surgeons in your presentation especially colleagues (by name) in the audience. Results: The lessons learned from the LIHNCS trial are seamlessly transferrable to all surgical trials. In this modern research driven era surgeons must continue to build upon evidence based practice. This can only be achieved by a collaborative approach to ensure the continued health of all specialities. http://dx.doi.org/10.1016/j.bjoms.2014.07.070
e65
65 Vascular Endothelial Growth Factor (VEGF) inhibitors as a novel strategy in the treatment of Arterio Venous Malformations (AVMs): time for a clinical study David Koppel ∗ , Rhian Touyz Regional Maxillofacial Unit, Glasgow The current standard treatment of AVMs is based around embolisation and surgery, used individually or in combination. The outcomes are often suboptimal with radical surgery resulting in significant morbidity and less radical surgery often leading to recurrence. Pathological processes associated with AVM include angiogenesis and neogenesis. At the molecular level, these processes are regulated by several growth factors of which VEGF and its tyrosine kinase receptors (VEGFR) play a dominant role. VEGFR expression and its intracellular signaling are increased in experimental and clinical AVM. VEGF inhibitors are increasingly used as anti-angiogenesis agents in the treatment of certain cancers. Numerous clinical studies have assessed therapeutic effects of bevacuzimab, a VEGF monoclonal antibody, in patients with Hereditary Hemorrhagic Telangiectasia. Results have been promising with most studies showing reduced bleeding and lesion regression with systemic and topical bevacuzimab. To our knowledge there are no clinical studies that have investigated the potential therapeutic benefit of antiangiogenic agents that target VEGF receptor tyrosine kinases, such as pazopanib, sorafenib, and suratinib. We propose that patients with failed treatment of AVM will benefit from locally administered VEGFR inihibitors. Accordingly we suggest that it is timely to conduct a clinical study to evaluate whether VEGFR inhibitors are beneficial in adult patients with AVM who have failed to respond to standard treatments. Here we invite colleagues to collaborate in this proposed clinical trial. http://dx.doi.org/10.1016/j.bjoms.2014.07.071 66 Development of a financially viable model for the outpatient management of mandibular fractures in a Level 1 Major Trauma Centre Jahrad Haq ∗ , S. Chegini, K. Fan, C. Huppa, R. Bentley King’s College Hospital, London Background: 200+ mandibular fractures are managed within this major trauma centre annually. A previous feasibility study has determined that outpatient management (DSU) of selected cases is clinically viable. If proven financially viable, there are potential cost, inpatient bed and CEPOD theatre-time savings to be made. Aim: To assess the economic feasibility of DSU management of mandibular fractures versus inpatient care.
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Abstracts / British Journal of Oral and Maxillofacial Surgery 52 (2014) e43–e74
Methods: 75 non-continuous patients with mandibular fractures were included retrospectively. Cases were deemed suitable for DSU if they had a Mandible Injury Severity Score < 10, and were medically/socially appropriate for DSU. Comparative cost calculations were performed for inpatient and outpatient scenarios. These included:bed-day cost, theatre time, consumables and staffing. Results: Overall average delay from admission to surgery was 0.9 days and inpatient length of stay (IPLOS) was 1.8 days. Of the seven patients assessed as suitable for DSU; mean delay to surgery was 1 day, and IPLOS 1.6 days. Cost comparison and financial savings: Inpatient and DSU theatre costs are comparable at £213.64 and £211.69 per 15mins respectively. Potential inpatient bed-day earnings are £1831. There is a premium ‘intermediate OMFS procedure’ Healthcare Resource Group tariff of £102.80 as DSU over inpatient. Conclusion: A conservative 10% of mandibular fractures can be safely managed as outpatients. This should increase as the DSU service gains experience handling more complex fractures. A business case can be made to establish a rapidaccess link to existing DSU lists to release inpatient beds in a safe manner on the basis of increased income and decreased expenditure. http://dx.doi.org/10.1016/j.bjoms.2014.07.072 67 Human Papillomavirus infection is not highly prevalent in oral and laryngeal dysplasia and is not associated with progression to dysplasia Victor Lopes ∗ , Zaid Sadiq, Brendan Conn, Max Robinson, Anas Saeed Univeristy of Edinburgh/NHS Lothian Aim: To establish the proportions of oral and laryngeal dysplastic lesions that were positive for high-risk Human Papillomavirus (HPV) infection and further to identify if HPV infection was more prevalent in progressed (to carcinoma) or non-progressed dysplastic lesions. Materials: Archived histological specimens of 38 oral and 62 laryngeal dysplasias were retrieved from the pathology archive of the Royal Infirmary of Edinburgh, with appropriate ethical approval. Initial screening for HPV presence was done using immunohistochemical staining for p16 as a surrogate marker. Positive samples were tested for high risk HPV subtypes using in-situ hybridisation methods. Results: A total of two (5%) oral lesions were p16 positive; twenty three (61%) oral dysplasias progressed to carcinoma and 15 (39%) did not. Both of the p16 positive lesions were in the cohort that progressed to carcinoma and both were positive for high risk HPV. Statistical analysis showed a relative risk of 1.7 where p=0.5. A total of 11 (18%) laryngeal lesions were positive for p16; 8 (13%) from the non-progressed group and 3 (5%) from the
progressed group. The relative risk was 0.7 where p=0.73. Only one case overall was positive for high risk HPV. Conclusion: The overall prevalence of HPV in oral and laryngeal dysplasia is in similar proportions to that seen in squamous cancer at each site however there is not any statistical difference in the proportions of cases positive for HPV between progressed and non-progressed dysplasia at each site. HPV is not associated with progression to carcinoma. http://dx.doi.org/10.1016/j.bjoms.2014.07.073 68 Diagnostic investigation of parotid neoplasms - A 14 year experience of freehand fine needle aspiration cytology and ultrasound guided core needle biopsy David Tighe ∗ , S. Haldar, U. Mandalia, E. Skelton, K. Ramesar, M. Williams, D. Howlett Eastbourne District General Hospital Introduction: Pre-operative cytological investigation of new parotid lumps is contenious. Many clinicians advocate for its routine use whilst others believe current methods are rarely change patient management. Our study contributes to a growing consensus that Ultrasound Guided Core Biopsy of parotid neoplasms is safe, reliable and readily available within a moderately resourced hospital setting. Methods: A 14 year retrospective analysis of one centre’s pathology archive of parotid neoplasms (n=398). The sequence of tests before definitive histological diagnosis is investigated. Diagnostic accuracy of free - hand Fine Needle Aspiration Cytology (FNAC) and Ultrasound Guided Core Biopsy (USCB) is compared with definitive histopathology resection specimens. Results: 398 patients with parotid neoplasms were investigated with 120 FNAC’s and 313 USCB before 257 patients had surgical resection. Overall sample adequacy of FNAC (44%) and USCB (96%) meant decision to treat was frequently delayed where FNAC was initially employed. The diagnostic accuracy for benign diagnoses (FNAC 40-59% and USCB 93-98%) and malignant diagnoses (FNAC 85% and USCB 99%) is comparable to other published studies and underlines the relative value of USCB in pre-operative decision making. No salivary complications, seeding or facial nerve injuries were encountered in our series of FNAC or USCB. Conclusion: The role of FNAC in preoperative decision making for parotid neoplasm is rightly challenged. Whilst improved diagnostic accuracy rates with clinic based cytology technical support has been demonstrated the cost is substantial. USCB does have greater diagnostic accuracy and expertise and equipment is readily resourced in the typical district general hospital. http://dx.doi.org/10.1016/j.bjoms.2014.07.074
nificant (p<0.001) at determining outcome, and was hence likely to be useful. http://dx.doi.org/10.1016/j.bjoms.2014.07.069 64 Successful Recruitment to Head & Neck Trials: lessons learned from the LIHNCS Trial James McCaul ∗ , James Cymerman, Raghav Kulkarni, Kayleigh Gilbert, Amy Pendrill, Jacquelline Quantrill, Janet Dunn BRI/Bradford Institute for Health Research Background: Recruitment to the Lugol’s Iodine in Head and Neck Cancer Surgery (LIHNCS) trial is now complete. This is the largest and fastest recruiting head and neck surgical oncology trial in the UK, and will be delivered on schedule. Invaluable lessons have been learned throughout the process, which we wish to share to ensure continued surgical research success. Methods: The LIHNCS team developed number of strategies to overcome challenges faced in recruitment of patients into a surgical trial. These include: • Good Clinical Practice training specific to surgeons (a de novo course developed by the Chief Investigator Professor McCaul). • Attainment of Portfolio status - to aid recognition, funding and appropriate staffing. • Site initiation visits in person from members of the research team rather than via a teleconference call. • Close monitoring of recruitment figures per site per month to recognise any sites that may be struggling with recruitment. • Named surgeon certificates rewarding increasing levels of patient recruitment. A research specific document for personal portfolios. • Continuous exposure of the trial at national and international meetings. Acknowledging recruiting sites and surgeons in your presentation especially colleagues (by name) in the audience. Results: The lessons learned from the LIHNCS trial are seamlessly transferrable to all surgical trials. In this modern research driven era surgeons must continue to build upon evidence based practice. This can only be achieved by a collaborative approach to ensure the continued health of all specialities. http://dx.doi.org/10.1016/j.bjoms.2014.07.070
e65
65 Vascular Endothelial Growth Factor (VEGF) inhibitors as a novel strategy in the treatment of Arterio Venous Malformations (AVMs): time for a clinical study David Koppel ∗ , Rhian Touyz Regional Maxillofacial Unit, Glasgow The current standard treatment of AVMs is based around embolisation and surgery, used individually or in combination. The outcomes are often suboptimal with radical surgery resulting in significant morbidity and less radical surgery often leading to recurrence. Pathological processes associated with AVM include angiogenesis and neogenesis. At the molecular level, these processes are regulated by several growth factors of which VEGF and its tyrosine kinase receptors (VEGFR) play a dominant role. VEGFR expression and its intracellular signaling are increased in experimental and clinical AVM. VEGF inhibitors are increasingly used as anti-angiogenesis agents in the treatment of certain cancers. Numerous clinical studies have assessed therapeutic effects of bevacuzimab, a VEGF monoclonal antibody, in patients with Hereditary Hemorrhagic Telangiectasia. Results have been promising with most studies showing reduced bleeding and lesion regression with systemic and topical bevacuzimab. To our knowledge there are no clinical studies that have investigated the potential therapeutic benefit of antiangiogenic agents that target VEGF receptor tyrosine kinases, such as pazopanib, sorafenib, and suratinib. We propose that patients with failed treatment of AVM will benefit from locally administered VEGFR inihibitors. Accordingly we suggest that it is timely to conduct a clinical study to evaluate whether VEGFR inhibitors are beneficial in adult patients with AVM who have failed to respond to standard treatments. Here we invite colleagues to collaborate in this proposed clinical trial. http://dx.doi.org/10.1016/j.bjoms.2014.07.071 66 Development of a financially viable model for the outpatient management of mandibular fractures in a Level 1 Major Trauma Centre Jahrad Haq ∗ , S. Chegini, K. Fan, C. Huppa, R. Bentley King’s College Hospital, London Background: 200+ mandibular fractures are managed within this major trauma centre annually. A previous feasibility study has determined that outpatient management (DSU) of selected cases is clinically viable. If proven financially viable, there are potential cost, inpatient bed and CEPOD theatre-time savings to be made. Aim: To assess the economic feasibility of DSU management of mandibular fractures versus inpatient care.
e66
Abstracts / British Journal of Oral and Maxillofacial Surgery 52 (2014) e43–e74
Methods: 75 non-continuous patients with mandibular fractures were included retrospectively. Cases were deemed suitable for DSU if they had a Mandible Injury Severity Score < 10, and were medically/socially appropriate for DSU. Comparative cost calculations were performed for inpatient and outpatient scenarios. These included:bed-day cost, theatre time, consumables and staffing. Results: Overall average delay from admission to surgery was 0.9 days and inpatient length of stay (IPLOS) was 1.8 days. Of the seven patients assessed as suitable for DSU; mean delay to surgery was 1 day, and IPLOS 1.6 days. Cost comparison and financial savings: Inpatient and DSU theatre costs are comparable at £213.64 and £211.69 per 15mins respectively. Potential inpatient bed-day earnings are £1831. There is a premium ‘intermediate OMFS procedure’ Healthcare Resource Group tariff of £102.80 as DSU over inpatient. Conclusion: A conservative 10% of mandibular fractures can be safely managed as outpatients. This should increase as the DSU service gains experience handling more complex fractures. A business case can be made to establish a rapidaccess link to existing DSU lists to release inpatient beds in a safe manner on the basis of increased income and decreased expenditure. http://dx.doi.org/10.1016/j.bjoms.2014.07.072 67 Human Papillomavirus infection is not highly prevalent in oral and laryngeal dysplasia and is not associated with progression to dysplasia Victor Lopes ∗ , Zaid Sadiq, Brendan Conn, Max Robinson, Anas Saeed Univeristy of Edinburgh/NHS Lothian Aim: To establish the proportions of oral and laryngeal dysplastic lesions that were positive for high-risk Human Papillomavirus (HPV) infection and further to identify if HPV infection was more prevalent in progressed (to carcinoma) or non-progressed dysplastic lesions. Materials: Archived histological specimens of 38 oral and 62 laryngeal dysplasias were retrieved from the pathology archive of the Royal Infirmary of Edinburgh, with appropriate ethical approval. Initial screening for HPV presence was done using immunohistochemical staining for p16 as a surrogate marker. Positive samples were tested for high risk HPV subtypes using in-situ hybridisation methods. Results: A total of two (5%) oral lesions were p16 positive; twenty three (61%) oral dysplasias progressed to carcinoma and 15 (39%) did not. Both of the p16 positive lesions were in the cohort that progressed to carcinoma and both were positive for high risk HPV. Statistical analysis showed a relative risk of 1.7 where p=0.5. A total of 11 (18%) laryngeal lesions were positive for p16; 8 (13%) from the non-progressed group and 3 (5%) from the
progressed group. The relative risk was 0.7 where p=0.73. Only one case overall was positive for high risk HPV. Conclusion: The overall prevalence of HPV in oral and laryngeal dysplasia is in similar proportions to that seen in squamous cancer at each site however there is not any statistical difference in the proportions of cases positive for HPV between progressed and non-progressed dysplasia at each site. HPV is not associated with progression to carcinoma. http://dx.doi.org/10.1016/j.bjoms.2014.07.073 68 Diagnostic investigation of parotid neoplasms - A 14 year experience of freehand fine needle aspiration cytology and ultrasound guided core needle biopsy David Tighe ∗ , S. Haldar, U. Mandalia, E. Skelton, K. Ramesar, M. Williams, D. Howlett Eastbourne District General Hospital Introduction: Pre-operative cytological investigation of new parotid lumps is contenious. Many clinicians advocate for its routine use whilst others believe current methods are rarely change patient management. Our study contributes to a growing consensus that Ultrasound Guided Core Biopsy of parotid neoplasms is safe, reliable and readily available within a moderately resourced hospital setting. Methods: A 14 year retrospective analysis of one centre’s pathology archive of parotid neoplasms (n=398). The sequence of tests before definitive histological diagnosis is investigated. Diagnostic accuracy of free - hand Fine Needle Aspiration Cytology (FNAC) and Ultrasound Guided Core Biopsy (USCB) is compared with definitive histopathology resection specimens. Results: 398 patients with parotid neoplasms were investigated with 120 FNAC’s and 313 USCB before 257 patients had surgical resection. Overall sample adequacy of FNAC (44%) and USCB (96%) meant decision to treat was frequently delayed where FNAC was initially employed. The diagnostic accuracy for benign diagnoses (FNAC 40-59% and USCB 93-98%) and malignant diagnoses (FNAC 85% and USCB 99%) is comparable to other published studies and underlines the relative value of USCB in pre-operative decision making. No salivary complications, seeding or facial nerve injuries were encountered in our series of FNAC or USCB. Conclusion: The role of FNAC in preoperative decision making for parotid neoplasm is rightly challenged. Whilst improved diagnostic accuracy rates with clinic based cytology technical support has been demonstrated the cost is substantial. USCB does have greater diagnostic accuracy and expertise and equipment is readily resourced in the typical district general hospital. http://dx.doi.org/10.1016/j.bjoms.2014.07.074