Concerns raised by people treated for head and neck cancer: a secondary analysis of audiotaped consultations in a health services follow-up clinic.

PURPOSE: People treated for head and neck cancer (HNC) face various barriers in communicating concerns with consultants. Our aim was to investigate the number of concerns raised between patients using the Patient Concerns Inventory (PCI) and those who did not. The PCI is a 57-item prompt list used in routine HNC follow-up clinics. Additionally, we aimed to examine whether who initiated the concerns differed between groups and the factors that may predict this initiation. METHODS: Secondary data analysis included 67 participants across 15 HNC consultants from specialist cancer centres in Liverpool and Leeds. Seven consultants utilised the PCI and eight did not, assigned by preferential and random assignment. RESULTS: Patients in the PCI group raised on average 2.5 more concerns than patients in the non-PCI group (p < .001). There was no significant relationship between group and who initiated the first concern (p = .28). A mixed-effects logistic regression was found to significantly predict who initiated the first concern in consultations (p < .05). DISCUSSION: The number of concerns raised by patients increased when the PCI was introduced pre-HNC consultation. A number of factors were shown to predict the number of concerns raised in consultations by both patient and consultant. As concerns may not be raised further following the concern mentioned, we propose that the discussion of concerns needs to be maintained by the clinician throughout the consultation and not solely at the start. CONCLUSION: The PCI promoted the sharing of concerns in follow-up consultations between patient and consultant.

The Patient Concerns Inventory in head and neck oncology: a structured review of its development, validation and clinical implications.

INTRODUCTION: The Patient Concerns Inventory (PCI) is a condition specific prompt list that was initially developed for head and neck cancer (HNC) and is referred to as the PCI-HN. There have been numerous publications regarding the PCI-HN, since it was first published in 2009. To date, there has not been a review of its development, validation and clinical implications. A collation of relevant papers into key sections allows multidisciplinary teams and researchers to have an overview of the PCI-HN's background, evaluation and utility. This is essential if colleagues are to have confidence in the tool and be able to reflect on how to optimise its use in clinical practice. METHODS: Five search engines were used: EMBASE, Medline, PubMed, CINAHL and Handle-on-QOL for the specific term 'Patient Concerns Inventory' up to and including 1st February 2022. In addition, an accumulation of PCI-HN data of 507 HNC patients was drawn from previous studies in Liverpool and Leeds between 2007 and 2020 and was analysed specifically for this paper. RESULTS: 54 papers relating to the PCI-HN were identified. The review is structured into eight sections: (1) What is the PCI-HN and how does it work; (2) Feasibility and acceptability; (3) Psychometrics; (4) Items selected and frequency (5) Associations with Health-Related Quality of Life (HRQOL) and casemix; (6) Other observational studies; (7) Randomised trial evaluation; (8) General discussion and further research. CONCLUSIONS: As the term PCI is quite ubiquitous and produces many hits when searching the literature, this review provides a very concise and convenient historical context for the PCI-HN and collates the current literature.

Improving quality of life through the routine use of the patient concerns inventory for head and neck cancer patients: main results of a cluster preference randomised controlled trial.

PURPOSE: The patient concerns inventory (PCI) is a prompt list allowing head and neck cancer (HNC) patients to discuss issues that otherwise might be overlooked. This trial evaluated the effectiveness of using the PCI at routine outpatient clinics for one year after treatment on health-related QOL (HRQOL). METHODS: A pragmatic cluster preference randomised control trial with 15 consultants, 8 'using' and 7 'not using' the PCI intervention. Patients treated with curative intent (all sites, disease stages, treatments) were eligible. RESULTS: Consultants saw a median (inter-quartile range) 16 (13-26) patients, with 140 PCI and 148 control patients. Of the pre-specified outcomes, the 12-month results for the mean University of Washington Quality of Life (UW-QOLv4) social-emotional subscale score suggested a small clinical effect of intervention of 4.6 units (95% CI 0.2, 9.0), p = 0.04 after full adjustment for pre-stated case-mix. Results for UW-QOLv4 overall quality of life being less than good at 12 months (primary outcome) also favoured the PCI with a risk ratio of 0.83 (95% CI 0.66, 1.06) and absolute risk 4.8% (- 2.9%, 12.9%) but without achieving statistical significance. Other non-a-priori analyses, including all 12 UWQOL domains and at consultant level also suggested better HRQOL with PCI. Consultation times were unaffected and the number of items selected decreased over time. CONCLUSION: This novel trial supports the integration of the PCI approach into routine consultations as a simple low-cost means of benefiting HNC patients. It adds to a growing body of evidence supporting the use of patient prompt lists more generally.

The After Diagnosis Head and Neck cancer-specific Patient Concerns Inventory (HaNC-AD) as a pre-treatment preparation aid during the COVID-19 pandemic.

The coronavirus disease 2019 pandemic has resulted in new challenges for clinicians, head and neck cancer (HNC) patients and carers. There is evidence that the current crisis is affecting the management of HNC patients. Most healthcare systems have introduced remote consultations to decrease the risk of coronavirus infection to patients, carers and clinicians. At present, HNC patients may be anxious and due to logistical issues, may not be adequately prepared for their treatment. To ensure that patients have a thorough understanding of their treatment and expected outcome during the current COVID-19 crisis there may be merit in the use of the HaNC-AD PCI.

Improving quality of life through the routine use of the patient concerns inventory for head and neck cancer patients: baseline results in a cluster preference randomised controlled trial.

PURPOSE: The main aim of this paper is to present baseline demographic and clinical characteristics and HRQOL in the two groups of the Patient Concerns Inventory (PCI) trial. The baseline PCI data will also be described. METHODS: This is a pragmatic cluster preference randomised control trial with 15 consultant clusters from two sites either 'using' (n = 8) or 'not using' (n = 7) the PCI at a clinic for all of their trial patients. The PCI is a 56-item prompt list that helps patients raise concerns that otherwise might be missed. Eligibility was head and neck cancer patients treated with curative intent (all sites, stage of disease, treatments). RESULTS: From 511 patients first identified as eligible when screening for the multi-disciplinary tumour board meetings, 288 attended a first routine outpatient baseline study clinic after completion of their treatment, median (IQR) of 103 (71-162) days. At baseline, the two trial groups were similar in demographic and clinical characteristics as well as in HRQOL measures apart from differences in tumour location, tumour staging and mode of treatment. These exceptions were cluster (consultant) related to Maxillofacial and ENT consultants seeing different types of cases. Consultation times were similar, with PCI group times taking about 1 min longer on average (95% CL for the difference between means was from - 0.7 to + 2.2 min). CONCLUSION: Using the PCI in routine post-treatment head and neck cancer clinics do not elongate consultations. Recruitment has finished but 12-month follow-up is still ongoing.

Microorganisms involved in deep neck infection (DNIs) in Greece: detection, identification and susceptibility to antimicrobials.

BACKGROUND: To determine, from October 2010 to October 2018, the epidemiology of Deep Neck Infections (DNIs), regarding the detection, the identification and the susceptibility to antimicrobials of causative microorganisms, in Thessaly-Central Greece. METHODS: An analysis of data from a prospective database was conducted on 610 consecutive patients with DNIs treated in the Otolaryngology / Head & Neck Surgery Department of University Hospital of Larissa. Demographics, clinical features and microbiological data were analyzed. RESULTS: Among the 610 patients (1,9/1 male to female ratio, mean age: 39,24 ± 17,25) with DNIs, 579 had a single space (94,9%), while the remaining 31 had a multi-space (5,1%) DNI. The most common areas affected were the peritonsillar space (84,6%) followed by the submandibular space (6,5%). Clinical samples were obtained from 462 patients, and were tested by culture and by the application of 16S rRNA PCR. Two hundred fifty-five samples (55,2%) gave positive cultures, in which Streptococcus pyogenes and Staphylococcus aureus were predominant. The application of the 16S rRNA PCR revealed that 183 samples (39,6%) were positive for bacterial DNA; 22 of them, culture negative, were found to be positive for anaerobic (Fusobacterium necrophorum, Actinomyces israellii etc) and for fastidious microorganisms (Brucella mellitensis, Mycobacterium avium). CONCLUSION: DNIs represent a medical and surgical emergency and evidence-guided empirical treatment with intravenous infusion of antibiotics at the time of diagnosis is mandatory, highlighting the importance of epidemiological studies regarding the causative microorganisms. Although, in our study, the predominant pathogens were S. pyogenes and S. aureus, the combination of culture and molecular assay revealed that anaerobic bacteria play also a significant role in the pathogenesis of DNIs. Based on the local epidemiology, we propose as empirical therapy the intravenous use of a beta-lactam /beta-lactamase inhibitor; metronidazole or clindamycin can be added only in specific cases such as in immunocompromised patients.

Improving quality of life through the routine use of the patient concerns inventory for head and neck cancer patients: a cluster preference randomized controlled trial.

BACKGROUND: The consequences of treatment for Head and Neck cancer (HNC) patients has profound detrimental impacts such as impaired QOL, emotional distress, delayed recovery and frequent use of healthcare. The aim of this trial is to determine if the routine use of the Patients Concerns Inventory (PCI) package in review clinics during the first year following treatment can improve overall quality of life, reduce the social-emotional impact of cancer and reduce levels of distress. Furthermore, we aim to describe the economic costs and benefits of using the PCI. METHODS: This will be a cluster preference randomised control trial with consultants either 'using' or 'not using' the PCI package at clinic. It will involve two centres Leeds and Liverpool. 416 eligible patients from at least 10 consultant clusters are required to show a clinically meaningful difference in the primary outcome. The primary outcome is the percentage of participants with less than good overall quality of life at the final one-year clinic as measured by the University of Washington QOL questionnaire version 4 (UWQOLv4). Secondary outcomes at one-year are the mean social-emotional subscale (UWQOLv4) score, Distress Thermometer (DT) score ≥ 4, and key health economic measures (QALY-EQ-5D-5 L; CSRI). DISCUSSION: This trial will provide knowledge on the effectiveness of a consultation intervention package based around the PCI used at routine follow-up clinics following treatment of head and neck cancer with curative intent. If this intervention is (cost) effective for patients, the next step will be to promote wider use of this approach as standard care in clinical practice. TRIAL REGISTRATION: 32,382. Clinical Trials Identifier, NCT03086629 . PROTOCOL: Version 3.0, 1st July 2017.

Incidence and outcome for patients with occult lymph node involvement in T1 and T2 oral squamous cell carcinoma: a prospective study.

BACKGROUND: The evidence base to inform the decision making process in patients with early stage oral cancer and a clinical and radiological N0 neck remains insufficient to answer the question when it is safe to "watch and wait" and when to proceed with a selective neck dissection. METHODS: A total of 327 consecutive cases of histopathologically staged T1-2, N0-1 and M0, but clinically N0, squamous cell carcinoma of the tongue were prospectively analysed. Univariate and multivariate analyses were used for statistical analysis and are represented as Kaplan-Meier analyses or Cox proportional hazard regression analysis. RESULTS: In 61 patients (18.65%) lymph node involvement was found in the histopathological processing. The mean survival of all patients was 73.3 ± 48.6 months. The 2-year and 5-year overall survival rates of all patients were 87.5% and 68.4%, respectively. The 2-year and 5-year survival rates for stage N0 were 89.1% and 70.7% compared to 83.3% and 62.9% in N1 situations. The 2-year and 5-year survival rates for stage T1 were 87.9% and 73.6% compared to 87.2% and 65.3% in stage T2, respectively. The time to recurrence in stage N0 was 35.1 ± 30.5 months compared to 25.63 ± 24.6 months in cases with N1 disease. Stage T1 was associated with a time to recurrence of 38.1 ± 33.9 months compared with 27.2 ± 22.7 months in patients classified T2.Variables found to be strongly associated with survival in the univariate analysis included older age, higher tumour and N stage, and grading. Age, tumour stage (p = 0.011, 95% CI, 1.09 to 2.0), nodal stage (p = 0.038, 95% CI, 1.02 to 2.07), and recurrence were independently and significantly associated with survival in the multivariate analysis. CONCLUSIONS: This confirms a high overall disease free survival for patients with T1 and N0 treated with single modality surgery and in common with the literature confirms the poor impact on prognosis of the N positive neck.

Coping with oral cancer: the impact of health and disease-related personality traits.

PURPOSE: Oral tumours lead to critical reductions in quality of life and well being. Coping with illness is a multidimensional construct that is affected by various factors, including social structure, social support, locus of control and religious considerations. However, the effect of personality on coping with illness has hardly been studied. In this context, just one personality model has been developed, but this defines personality in very wide dimensions. Therefore, this study considered the personality factors related to health and disease and aimed to identify potential clinical applications in patients with oral cancer. METHODS: We enrolled 104 patients suffering from oral cancer. Participants were asked about their personality and illness coping styles using the Freiburg Personality Inventory and the Freiburg Questionnaire of Coping with Illness, respectively. RESULTS: Regression analyses revealed that specific personality structures of the patients determine their way of coping. Patients primarily used active and problem-oriented coping styles; spirituality, depressive coping and minimization were used less frequently. CONCLUSIONS: The results demonstrate that personality affects coping behaviour. When treating patients, both situational factors and personality traits affect how patients cope with their disease. We note that it is important to give particular attention to patients who use depressive coping styles, as these patients are often incapable of coping with their diseases without external support.

Morphological and morphometric evaluation of the ilium, fibula, and scapula bones for oral and maxillofacial reconstruction.

This study aimed to evaluate the osteometric boundaries of the ilium, fibula, and scapula beyond which reconstruction of oromandibular and craniofacial defects, using these free flaps, may not be optimal. Fibula, scapula, and iliac bones were obtained bilaterally from 33 female and 27 male European adult cadavers (n = 60). Adapting classical anthropometric methods to surgical needs by modifying the measuring bone localizations and measurement points, a measuring system of osteometry and morphometry was used, to quantify the usable bone length of the iliac crest, fibula, and lateral border of the scapula and to localize an oval region (OR) in the ilium. The thin, translucent OR of ilium was localized 62.4 ± 5.6 mm posterior to the maximum concavity between the anterior superior (ASIS) and anterior inferior iliac spine and 26.7 ± 6 mm caudal to the intermediate line of the iliac crest. The available iliac crest was measured from ASIS to the posterior superior iliac spine (PSIS) 247.5 ± 12.6 mm, fibula supplied 170.2 ± 19.1 mm harvestable bone, and the lateral border of the scapula 94.3 ± 8.5 mm [Corrected]. The OR influenced the harvestable bone shape and volume of the ilium. Measuring of the localization points of OR, we found that the size of the OR was very variable and that the height of the neomandible reconstructed with iliac crest might alter with aging. Our findings contribute with knowledge of detailed morphometric measurements on commonly used donor bones to the planning strategies of volumetric defects in oral and maxillofacial region by precise osteometric localization method of OR and relativized length measurements.

Addressing cancer anorexia-cachexia in older patients: Potential therapeutic strategies and molecular pathways.

Cancer cachexia (CC) syndrome, a feature of cancer-associated muscle wasting, is particularly pronounced in older patients, and is characterised by decreased energy intake and upregulated skeletal muscle catabolic pathways. To address CC, appetite stimulants, anabolic drugs, cytokine mediators, essential amino acid supplementation, nutritional counselling, cognitive behavioural therapy, and enteral nutrition have been utilised. However, pharmacological treatments that have also shown promising results, such as megestrol acetate, anamorelin, thalidomide, and delta-9-tetrahydrocannabinol, have been associated with gastrointestinal and cardiovascular complications. Emerging evidence on the efficacy of probiotics in modulating gut microbiota also presents a promising adjunct to traditional therapies, potentially enhancing nutritional absorption and systemic inflammation control. Additionally, low-dose olanzapine has demonstrated improved appetite and weight management in older patients undergoing chemotherapy, offering a potential refinement to current therapeutic approaches. This review aims to elucidate the molecular mechanisms underpinning CC, with a particular focus on the role of anorexia in exacerbating muscle wasting, and to propose pharmacological and non-pharmacological strategies to mitigate this syndrome, particularly emphasising the needs of an older demographic. Future research targeting CC should focus on refining appetite-stimulating drugs with fewer side-effects, specifically catering to the needs of older patients, and investigating nutritional factors that can either enhance appetite or minimise suppression of appetite in individuals with CC, especially within this vulnerable group.

Identifying risk factors for allogenic blood transfusion in oral and oropharyngeal cancer surgery with free flap reconstruction.

PURPOSE: Several observational studies in head and neck cancer have reported that allogenic blood transfusion is associated with increased postoperative complications, increased risk of tumor recurrence, and worse prognosis. The aim of this study was to identify preoperative and intraoperative factors predicting blood transfusion in patients undergoing surgery for oral and oropharyngeal cancer. PATIENTS AND METHODS: We conducted a retrospective cohort study of patients undergoing tumor resection and free flap reconstruction for locally advanced oral and oropharyngeal squamous cell carcinoma between 2000 and 2008. The primary outcome variable was perioperative exposure to allogenic blood transfusion. Univariate and multivariate logistic regression models were used to determine predictors of blood transfusion. RESULTS: A cohort of 142 participants was found eligible. In a multivariate model, Charlson score ≥ 1 (OR, 5.2; 95% CI, 1.4 to 19.3; P = .01), preoperative hemoglobin levels ≤ 12 g/dl (OR, 4.4; 95% CI, 1.2 to 16.2; P = .03), bone resection (OR, 5.1; 95% CI, 1.5 to 17.8; P = .01), and osseous free tissue transfer (OR, 8.8; 95% CI, 1.0 to 74.8; P = .046) were independently associated with an increased risk of blood transfusion. CONCLUSION: Our study identified patient- and surgery-related factors predicting a higher risk of exposure to allogenic blood transfusion. This readily available preoperative information could be used to better stratify patients according to their transfusion risk and may thereby guide blood conservation strategies in high-risk patients.

Prognostic factors in oral cancer surgery - results from a UK tertiary centre.

INTRODUCTION: Oral cancer surgery is complicated by the diverse nature of clinical and histopathological presentations that occur. Current National guidance recognises the significant role that surgical margin status plays in the overall survival of patients. Many other histopathological factors influence patient survival, the importance of which varies between the literature. MATERIALS AND METHODS: In this prospective longitudinal study, all patients diagnosed with squamous cell carcinoma who had primary surgical treatment under general anaesthesia were included. Surgery was performed by one surgical team within this tertiary referral centre. Patients were followed up for a maximum of 7 years following their surgery. RESULTS: A total of 250 patients were included from 2015 to 2022. Patients were 61.44 years old (SD 13.23) at diagnosis, and 56.4% were male (n = 141). Pathology was mainly pT1 (39.1%) and the most common sites were the border of tongue (31.2%) and floor of mouth (18.8%). 43.4% of patients had clear surgical margins, with overall survival being significantly associated with margin status (p = 0.0079). Extra-capsular spread was significantly associated with higher risk of death from metastatic head and neck cancer (p = 0.014), whereas presence of high-grade dysplasia at surgical margins and depth of invasion of tumour were not. CONCLUSION: This study has reinforced the importance of surgical margin clearance and as such the development of intra-operative techniques to ensure this is imperative. The significance of extra-capsular spread in survival has also been demonstrated. Discussion regarding the current deficiency in accurate pre-operative diagnostic methods for extra capsular spread is covered.

The Evaluation of Training Oral and Maxillofacial Trainees in Head and Neck Cancer Doctor-Patient Communication Using the Patient Concerns Inventory.

Head and neck cancer has a significant impact on a patient's health related quality of life (HRQOL). The head and neck specific Patient Concerns Inventory (PCI-HN) has been utilised to enhance doctor-patient dialogue in routine consultations. To date there has been no formal training for oral and maxillofacial surgery (OMFS) surgical trainees in the use of the PCI-HN in consultations. The aim of the study was to evaluate training for OMFS surgical trainees in the use of the PCI-HN, using simulated follow-up HNC consultations, in order to improve doctor-patient communication skills. MATERIAL AND METHODS: Ten oral and maxillofacial surgical trainees completed actor simulated HNC consultations before and after training. A study-specific mark scheme was developed based on the ComOn-Coaching rating scales and used to score the doctor-patient interaction. A group debrief afterwards explored the trainee's experiences of the training and consultations. RESULTS: All trainees showed an improvement in doctor-patient communication scores following their training. Overall, the six participants who were Specialty registrars, year 3 (ST3) or above, scored higher, than the four Specialty registrars, year 1-2 (ST1-2). The scores were higher if fewer PCI-HN items were discussed (3-4). The most frequently avoided PCI-HN items were intimacy and relationships. The trainees considered that their training was useful for organising their consultations and for providing holistic care. CONCLUSION: Although training improved surgeon-patient communication, further evaluation is required with a larger number of trainees and actual consultations in clinic.

Conditioning of microvascular venous flaps in rats.

Venous-only perfusion flaps have not been used widely because of the associated high failure rate. Tissue conditioning offers a broad scope of techniques that can be applied pre-, peri-, or postoperatively to promote the adaptation of the affected tissue to any subsequent stress. This study aimed to assess the survival rates associated with a pure venous perfusion flap and investigate whether the timing of the vascular conditioning can affect free flap survival. Forty-four rats were included in the experiment. Group I underwent veno-arterial anastomoses with epigastric graft with pure venous perfusion without tissue conditioning. Groups II and III were pretreated for 7 or 14 days with ischemic conditioning. These groups were compared with a control group (group IV) of conventionally perfused flaps. After the initial surgery, all flaps were assessed clinically, photometrically, and by indocyanine green videoangiography. The flap success rates were 0% in group I, 49.97% ± 24.34% in group II, and 64.95% ± 20.36% in group III. The control group showed an overall survival of 89.3% ± 6.51%. With suitable conditioning, pure venous blood supply can provide adequate perfusion in the rat epigastric flap model. The timing of vascular conditioning appears to be critical for flap survival.

Necrotizing Fasciitis in the Immediate Post-Operative Period Following Resection and Free Flap Reconstruction for Oral Cancer.

Necrotising fasciitis (NF) is a rapidly spreading bacterial infection of the fascial planes and can be fatal if is not treated urgently. Here, we present the case of a 65-year-old female, with oral squamous cell carcinoma, treated surgically with curative intent. On the second post-operative day from a mandibulectomy, selective neck dissection and reconstruction with a fibula free flap, she developed rapidly progressing NF, at the surgical site.

Health-related quality of life at 3 months following head and neck cancer treatment is a key predictor of longer-term outcome and of benefit from using the patient concerns inventory.

INTRODUCTION: During clinical follow-up it can be difficult to identify those head and neck cancer (HNC) patients who are coping poorly and could benefit from additional support. Health-related quality of life (HRQOL) questionnaires and prompt lists provide a means by which patients can express their perceived outcomes and raise concerns. The first aim of this secondary analysis following a randomized trial was to explore which patient characteristics, at around 3 months following treatment completion (baseline), best predict HRQOL 12 months later. The second aim was to attempt to ascertain which patients were most likely to benefit from using prompt list. METHODS: Cluster-controlled pragmatic trial data were analyzed. HRQOL was measured by the University of Washington Quality of life questionnaire (UW-QOLv4). The prompt list was the Patient Concerns Inventory (PCI-HN). RESULTS: The trial involved 15 eligible consultants and a median (inter-quartile range) of 16 (13-26) primary HNC patients per consultant, with 140 PCI patients and 148 controls. Baseline HRQOL was the dominant predictor of 12-month HRQOL with other predictors related to social, financial, and lifestyle characteristics as well as clinical stage and treatment. Although formal statistical tests for interaction were non-significant the trend in analyses over a range of outcomes suggested that patients with worse baseline HRQOL could benefit more from the PCI-HN. DISCUSSION: HRQOL early post-treatment is a key predictor of longer-term outcome. Measuring and using HRQOL and the PCI-HN are not only surrogates for predicting HRQOL at 15 months post-treatment, but also tools to help guide interventions.

Systematic review of health-related quality of life following thyroid cancer.

This systematic review provides a summary of all studies published between 2000 and 2019 using a health-related quality of life (HRQOL) patient-completed questionnaire to report outcomes following diagnosis and treatment of thyroid cancer. The search terms were "thyroid cancer" or "thyroid carcinoma," "quality of life" or "health related quality of life," and "questionnaire" or "patient reported outcome." EMBASE, PubMed, Medline, PsycINFO, CINAHL, and HaNDLE-On-QOL search engines were searched between 2 February and 23 February 2020. A total of 811 identified articles were reduced to 314 when duplicates were removed. After exclusion criteria (not thyroid specific, no quality of life questionnaires, and conference abstracts) were applied, 92 remained. Hand searching identified a further 2 articles. Of the 94 included, 16 had a surgical, 26 a primarily medical, and 52 a general focus. There were articles from 27 countries. A total of 49 articles were published from 2015 through 2019 inclusive. A total of 72 questionnaires were used among the articles and a range of 7 to 2215 participants were included within each article. This review demonstrated an increasing number of publications annually. The scope of enquiry into aspects of HRQOL following thyroid cancer is broad, with relatively few addressing surgical aspects and many focusing on the impact of radio-iodine. More research is required into shared decision-making in initial management decisions and HRQOL and interventions aimed specifically at addressing long-term HRQOL difficulties.

An Economic Evaluation Supported by Qualitative Data About the Patient Concerns Inventory (PCI) versus Standard Treatment Pathway in the Management of Patients with Head and Neck Cancer.

BACKGROUND: The head and neck cancer (HNC) Patient Concerns Inventory (PCI) is a condition-specific prompt list that allows patients to raise concerns to cancer consultants that otherwise might be overlooked. OBJECTIVE: This is the first economic evaluation of the PCI in patients with HNC investigating the costs and effects to the health service of not prioritising certain treatment pathways in addition to the primary cancer pathway. Additional costs can be accrued due to delayed referral to other appropriate services, e.g. hospital dentist. Economic evidence could influence future policy direction in this area globally. METHODS: Alongside a 3-year clustered randomised controlled trial, an economic evaluation was undertaken with Client Service Receipt Inventory data collected at three different time points (baseline and 6 and 12 months post-baseline). Patients were identified by a multidisciplinary team at the trial clinics. This economic analysis compared the PCI intervention versus the non-PCI treatment pathway. A deterministic and probabilistic sensitivity analysis was conducted to investigate the cost per quality-adjusted life-year (QALY) gain of the PCI versus non-PCI intervention treatment pathways. Qualitative data were also collected from seven consultants to triangulate findings from the economic evaluation. RESULTS: The analysis used data from 191 patients (66% of the full trial sample). The PCI inventory was low cost, at just over £13 per participant. The PCI intervention was cost effective and also cost saving, with an incremental cost difference of £295.91 over the 12-month follow-up period. The QALY values were higher in the PCI intervention strategy, with a value of 0.79, whereas the non-PCI group had a value of 0.76, thus the PCI intervention was dominant. The sensitivity analysis showed that, at a willingness-to-pay threshold of £20,000 per QALY gained, the probability of being cost effective was 0.85 (95% confidence interval [CI] 0.80-0.83). Qualitative results showed that consultants using the PCI reported an enhanced awareness of patients' overall post-treatment needs. DISCUSSION: The PCI provided an effective means to conduct clinical consultations by avoiding unnecessary healthcare costs and focussing on aspects of care most important to patients. The cost per QALY gain was within the National Institute for Health and Care Excellence guideline threshold. The economic evaluation showed that the PCI intervention strategy was dominant and therefore cost saving to the national health service (NHS) and was more effective in terms of treatment. CONCLUSION: The PCI appears to be a low-cost intervention that generates a cost-effective benefit to patients from a NHS perspective if rolled out as part of routine care. Qualitative evidence has shown that the use of the PCI is supported by consultants in routine practice. TRIAL REGISTRATION: Clinical Trials Identifier: NCT03086629.

Hyperbaric oxygen treatment of mandibular osteoradionecrosis: Combined data from the two randomized clinical trials DAHANCA-21 and NWHHT2009-1.

PURPOSE: Osteoradionecrosis (ORN) of the mandible is a serious complication of head and neck radiotherapy. This study aims to investigate the effect of hyperbaric oxygen (HBO) treatment on ORN in two randomized, controlled multicentre trials. METHODS AND MATERIALS: Patients with ORN with indication for surgical treatment were randomised to either group 1: surgical removal of necrotic mandibular bone supplemented by 30 pre- and 10 postoperative HBO exposures at 243 kPa for 90 min each, or group 2: surgical removal of necrotic bone only. Primary outcome was healing of ORN one year after surgery evaluated by a clinically adjusted version of the Common Toxicity Criteria of Adverse Events (CTCAE) v 3.0. Secondary outcomes included xerostomia, unstimulated and stimulated whole salivation rates, trismus, dysphagia, pain, Activities of Daily Living (ADL) and quality of life according to EORTC. Data were combined from two separate trials. Ninety-seven were enrolled and 65 were eligible for the intent-to-treat analysis. The 33% drop-out was equally distributed between groups. RESULTS: In group 1, 70% (21/30) healed compared to 51% (18/35) in group 2. HBO was associated with an increased chance of healing independent of baseline ORN grade or smoking status as well as improved xerostomia, unstimulated whole salivary flow rate, and dysphagia. Due to insufficient recruitment, none of the endpoints reached a statistically significant difference between groups. ADL data could only be obtained from 50 patients. CONCLUSION: Hyperbaric oxygen did not significantly improve the healing outcome of osteoradionecrosis after surgical removal of necrotic bone as compared to standard care (70% vs. 51%). This effect is not statistically significant due to the fact that the study was underpowered and is therefore prone to type II error.