Free flap donor site during early review consultations: is it really an issue?

Donor site complications, following microvascular free tissue transfer, can limit recovery in patients treated for head and neck cancer, with a curative intent. The Patient Concerns Inventory (PCI-HN) is a prompt list that provides patients with repeated opportunities to raise issues they feel are important and want to discuss. Here, we look at baseline results from a cluster preference randomised control trial with consultants either “using” or “not using” the PCI package in clinic to identify patient concerns. UWQOL results were presented from 67 consecutive patients having reconstruction with free tissue transfer and PCI results from 25 of these patients in the PCI arm of the trial. During early review consultations patients most wanted to discuss issues related to dental health, dry mouth, and chewing. Donor site morbidity, in our patient sample, did not appear to be an issue that patients wanted to discuss

Review of HaNDLE-on-QoL: a database of published papers that use questionnaires to report quality of life in patients with cancer of the head and neck

HaNDLE-on-QoL (Head And Neck Database Listing Evidence on QoL) is a searchable database that comprises abstracts of papers that have used questionnaires to report on quality of life (QoL) in patients with cancer of the head and neck. It can be searched by title, first author, year of publication, words used in the abstract, site of cancer, study design, and questionnaires used. The aim of this paper was to summarise its contents. In May 2017 we searched the website using the criteria above. It contained 1498 papers (including 149 reviews), and the number is increasing each year. Most studies concerned a combination of subsites in the head and neck (n = 871); 180 focused specifically on oral sites, and 109 on the larynx. The commonest topics were swallowing (n = 353), speech (n = 299), pain (n = 292), emotions (n = 226), and depression (n = 193). Nearly all the papers concerned function or predictors of health-related QoL (HRQoL), but 98 were clinical or randomised controlled trials. The site included over 250 questionnaires of which the most common were the European Organisation for Research and Treatment of Cancer C30 (EORTC-C30, n = 369), the EORTC-head and neck 35 (EORTC H & N35, n = 353), and the University of Washington Quality of Life (UWQoL) (n = 276). HaNDLE-on-QoL highlights the complexity of QoL after treatment and the diversity and range of the studies. It is a useful point of reference for those involved in clinical practice or research

Primary orbital reconstruction with selective laser melted core patient-specific implants: overview of 100 patients

Contemporary advances in technology have enabled the transfer of industrial laser melting technology to surgery, and its use can improve the accuracy of orbital restoration. The aim of this study therefore was to evaluate the accuracy of primary orbital reconstruction with the use of selective laser melted, patient-specific implants and navigation. A total of 100 patients with complex orbital fractures were included. Planned orbital volumes were compared with those achieved, and angles were compared with the unaffected side. Analysis included the overlay of postoperative on planned images (iPlan® 3.0.5, Brainlab). The mean (SD) orbital volume of the unaffected side was 27.2 (2.8) ml in men and 25.0 (2.6) ml in women. Fractures that involved the posterior third of the orbital floor and comminuted fractures showed significant orbital enlargement (p = 0.026). The mean (SD) reconstructed orbital volume was 26.9 (2.7) ml in men and 24.26 (2.5) ml in women. Three-dimensional analysis of the colour mapping showed minor deviations when compared with the unaffected side. The results suggest that a high degree of accuracy can be routinely achieved in these complex cases

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

This trial is funded by the RfPB on behalf of the NIHR (PB-PG-0215-36047).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.Publisher PDFPeer reviewe

HOPON (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis): a randomised controlled trial of hyperbaric oxygen to prevent osteoradionecrosis of the irradiated mandible: study protocol for a randomised controlled trial

Background: Osteoradionecrosis of the mandible is the most common serious complication of radiotherapy for head and neck malignancy. For decades, hyperbaric oxygen has been employed in efforts to prevent those cases of osteoradionecrosis that are precipitated by dental extractions or implant placement. The evidence for using hyperbaric oxygen remains poor and current clinical practice varies greatly. We describe a protocol for a clinical trial to assess the benefit of hyperbaric oxygen in the prevention of osteoradionecrosis during surgery on the irradiated mandible. Methods/design: The HOPON trial is a phase III, randomised controlled, multi-centre trial. It employs an unblinded trial design, but the assessment of the primary endpoint, i.e. the diagnosis of osteoradionecrosis, is assessed on anonymised clinical photographs and radiographs by a blinded expert panel. Eligibility is through the need for a high-risk dental procedure in the mandible where at least 50-Gy radiotherapy has been received. Patients are randomised 1:1 to hyperbaric oxygen arm (Marx protocol) : control arm, but both groups receive antibiotics and chlorhexidine mouthwash. The primary endpoint is the presence of osteoradionecrosis at 6 months following surgery, but secondary endpoints include other time points, acute symptoms and pain, quality of life, and where implants are placed, their successful retention. Discussion: The protocol presented has evolved through feasibility stages and through analysis of interim data. The classification of osteoradionecrosis has undergone technical refinement to ensure that robust definitions are employed. The HOPON trial is the only multi-centre RCT conducted in this clinical setting despite decades of use of hyperbaric oxygen for the prevention of osteoradionecrosis. Trial registration: European Clinical Trials Database, ID: EudraCT200700622527. First registered on 5 November 2007

Patients’ experience of recurrent/metastatic head and neck squamous cell carcinoma and their perspective on the EORTC QLQC30 and QLQ-H&N35 questionnaires: a qualitative study

Abstract Background Head and neck squamous cell carcinoma (HNSCC) and its associated treatments may affect all aspects of patients’ health-related quality of life (HRQoL). Although the EORTC QLQ-H&N35 is regularly administered to patients with HNSCC, there is a paucity of studies re-assessing the conceptual relevance of this patient-reported outcome (PRO) measure from a patient perspective. Furthermore, the content validity of the EORTC QLQ-C30 has not been widely documented in patients with recurrent and/or metastatic HNSCC. The objectives of this study were to understand patients’ experiences of recurrent/metastatic HNSCC and its treatments, and to evaluate the conceptual relevance and acceptability of the EORTC QLQ-C30 and QLQ-H&N35 from a patient perspective for use in clinical trials. Methods A literature review and clinician interviews were conducted to inform in-depth semi-structured telephone interviews with US patients who had received treatment for recurrent and/or metastatic HNSCC in the preceding 12 months. Interview transcripts were analysed thematically using ATLAS.ti v7; patient quotes were coded to identify concepts and themes to develop a conceptual model of HNSCC experience. Results Fourteen patients were interviewed (71% male, aged 35–84 years). Patients reported few symptoms pre-diagnosis including neck lump/swelling (n = 7/14, 50%) and/or difficulty swallowing (n = 3/14, 21%). Treatments generally comprised surgery and chemotherapy and/or radiotherapy. A number of side effects from all treatments were reported. Numbness, difficulty speaking and pain were the most reported side effects of surgery (n = 4/8, 50%); weight loss and fatigue were the most reported side effects of chemotherapy and/or radiotherapy (n = 8/13, 61%). All side effects negatively impacted patients’ HRQoL. Patients generally found the QLQ-C30 and QLQ H&N35 content to be understandable and conceptually relevant; excessive mucous production and neuropathic symptoms were among the suggested additions. Conclusions HNSCC and its diverse symptoms and treatments have a negative impact on many aspects of patients’ lives. A number of reported symptoms including difficulty speaking and swallowing, localised pain and fatigue may be important for treatment benefit evaluation in clinical trials from a patient perspective. The QLQ-C30 and QLQ-H&N35 are generally relevant and suitable for use in clinical trials. However, some items could be amended/added to ensure conceptual comprehensiveness of these measures