Follow-up arrangements in head and neck cancer clinics during the COVID-19 pandemic: results from two tertiary UK head and neck cancer centres.

INTRODUCTION: The aim of this paper is to report the pattern of follow-up that occurred for a cohort of head and neck cancer (HNC) patients across two large centres in the UK (Aintree and Leeds), as a consequence of the COVID-19 pandemic. METHODS: Patients had been treated for HNC with curative intent between April 2017 and October 2019 by 14 oral and maxillofacial (OMFS) and ear nose and throat (ENT) oncology surgeons in the Patient Concerns Inventory intervention trial. In October 2020, hospital records were reviewed, and information collected on the timing and mode (face-to-face/telephone/video) of follow-up consultations. In addition, recurrence, second primary tumours and deaths were recorded. RESULTS: At the start of 'lockdown', 212 members of the cohort were known to be alive. During the post-lockdown period (follow-up appointment data comprised 5 months in Aintree and 7 months in Leeds) 7 died and 13 were identified as palliative/recurrence/new primary/metastases ('new event'). In Aintree, the first ENT/OMFS consultations after lockdown were 51 (67%) telephone and 25 (33%) face-to-face appointments. In Leeds, 46 (78%) consultations were by telephone and 13 (22%) were face-to-face. The second ENT/OMFS consultations post lockdown included 11 (44%) telephone and 14 (56%) face-to-face in Aintree, and 21 (75%) telephone and 7 (25%) face-to-face in Leeds. CONCLUSIONS: These data suggest that clinicians favoured remote consultations. Variations in practice were observed but reached a point of a 'hybrid follow-up approach' that included both face-to-face and remote consultations. With the emergence of telemedicine, clinicians may consider a follow-up model tailored to risk stratification. The development of the mode of such a consultation model needs further evaluation.

Role of HLA-DQB1 alleles in the risk, signs and symptoms, and severity of celiac disease in a Venezuelan population.

INTRODUCTION AND AIMS: Celiac disease (CD) is a complex condition, whose main genetic determinant involves HLA molecules, specifically the HLA-DQ2 and/or HLA-DQ8 heterodimers. Nevertheless, the frequency of the alleles encoding those molecules has not been reported in Venezuelan celiac patients. Therefore, the aim of our study was to evaluate the frequency of the HLA-DQB1 alleles in individuals with symptoms suggestive of CD and define the diagnostic markers of the condition in a Venezuelan population. MATERIAL AND METHODS: A cross-sectional study included 516 individuals with symptoms suggestive of CD. Molecular typing of the HLA-DQB1 locus was performed using a polymerase chain reaction-sequence-specific oligonucleotide procedure (PCR-SSO). RESULTS: A total of 58.3% of the individuals with clinical manifestations consistent with CD presented with at least one risk allele (DQB1*0201 and/or DQB1*0302), and the diagnosis was confirmed in 40 of them. The patients with CD had a higher frequency of the DQB1*0201 risk allele (26.25%), followed by the DQB1*0302 (17.5%) allele. There was an association between the presence of risk alleles and the presence of lesions characteristic of CD (P = 0.001), and a correlation was found between the genetic predisposition to develop CD and the presence of anti-tissue transglutaminase antibodies (P = 0.0127). CONCLUSIONS: The results support the role of the DQB1*02 and DQB1*0302 alleles in CD susceptibility and the histologic alterations of the intestinal mucosa, in a Venezuelan population.

British Society for Immunology and United Kingdom Primary Immunodeficiency Network (UKPIN) consensus guideline for the management of immunoglobulin replacement therapy.

Currently, there is no guideline to support the use of immunoglobulin replacement therapy (IgRT) in primary and secondary immunodeficiency disorders in UK. The UK Primary Immunodeficiency Network (UK-PIN) and the British Society of Immunology (BSI) joined forces to address this need. Given the paucity of evidence, a modified Delphi approach was used covering statements for the initiation, monitoring, discontinuation of IgRT as well as home therapy programme. A group of six consultant immunologists and three nurse specialists created the statements, reviewed responses and feedback and agreed on final recommendations. This guideline includes 22 statements for initiation, 22 statements for monitoring, 11 statement for home therapy, and 19 statements for discontinuation of IgRT. Further areas of research are proposed to improve future delivery of care.

A 31-year review of composite radial forearm free flaps for head and neck reconstruction.

The aim of this study was to report the patient characteristics and radial fracture rates in a consecutive series of composite radial forearm free flap (CRFFF) for head and neck reconstruction over a 31-year period. The patients were identified from between 1990 to 2020 inclusive from theatre records and records from previous analyses at the Unit on free flap outcomes. Electronic case notes were accessed where available, to gather information on the operation, histopathology, and radiographs. Patients were categorised into three groups for analysis: (1) new oral cancers with a composite radial being the first choice of flap, (2) new oral cancers with a composite radial being the choice of flap following compromise of another bony flap, (3) osteoradionecrosis (ORN) cases. There were 103 CRFFF cases, median (IQR) age 69 (59-80) years, comprising 78 (Group 1), 5 (Group 2) and 20 (Group 3). The CRFFF failure rate was 6% (6/103) and the radius fracture rate was also 6% (6/103), both with 95% confidence interval 2.2-12.2%. Of the 6 radius fractures, 1 underwent surgical management (rush nailing), 1 died in hospital and the others managed with cast immobilisation. Two-year overall survival after surgery for the103 patients was 54% (SE 5%), while 5-year survival was 40% (SE 5%). In conclusion, in spite of the familiarity with other bone flaps such as fibular free flap, DCIA, scapula, and the limited bone stock and potential fracture related morbidity associated with the CRFFF, this flap still has a place in the surgical reconstructive armamentarium.

Patient characteristics and refusal to participate in a head and neck cancer intervention trial: experience of two tertiary UK head and neck cancer centres.

INTRODUCTION: Randomised clinical trials are an essential component for robust clinical evaluation. They are expensive to deliver but can fail to achieve the required outcomes. This paper reports details of trial recruitment in a head and neck Patient Concerns Inventory intervention trial from two UK head and neck tertiary centres. MATERIALS AND METHODS: Data were collected for a pragmatic cluster preference randomised control trial with 15 consultants recruiting patients treated with curative intent after a diagnosis of head and neck cancer (all sites, disease stages, treatments). Ethical approval was given to report on those not recruited by the following characteristics: trial site, trial arm, age, sex, tumour site, overall stage, index of multiple deprivation quintile, timeframe. RESULTS: There were 368 patients approached who remained eligible and 80 (22%) declined to participate. Logistic regression suggested that age group (p = 0.008) and index of multiple deprivation quintile group (p = 0.003) were independent predictors of refusal. CONCLUSIONS: Although recruitment to the trial was very good, it raised the issue of lower recruitment in the more deprived older group and lower social economic strata. Innovative ways need to be explored to facilitate the 'hard to reach' group contributing to, and benefiting from, clinical trials.

Risk stratification for poor health-related quality of life following head and neck cancer through the aid of a one-page item prompt list.

The aim of this work was to evaluate the usability of a single-page, patient-completed, condition-specific prompt list, the Patient Concerns Inventory (PCI-HN), to risk-stratify for poor health-related quality of life (HRQOL). Data were collected between 2008 and 2017. The main dataset comprised 310 patients first completing the PCI-HN and University of Washington Quality of Life questionnaire (UW-QOLv4) between 2012 and 2017. Another 201 patients first completing the PCI-HN between 2008 and 2011 provided a second dataset for independent validation. Subsequent completions of the PCI-HN in both groups and the distress thermometer (DT) were also used as further validation datasets. Associations between PCI-HN items selected by patients and a range of UW-QOLv4 outcomes were explored using conventional logistic regression and Chi-squared automated interaction detection (CHAID) analyses. One quarter of patients reported less than good HRQOL, range 26-29% across the four datasets. Several individual items from within the PCI-HN were predictive of adverse outcomes. The total number of items selected was also predictive. The single-sheet prompt list enables clinicians to identify patients at high risk of poor HRQOL. This simple approach has the potential to be integrated into routine clinical practice.

Immediate postoperative care on high dependency unit or ward following microvascular free tissue transfer: lessons learnt from a change in practice imposed during the COVID-19 pandemic.

The COVID-19 pandemic resulted in sudden changes to the established practice of using the high dependency unit (HDU) for the first night of postoperative care following microvascular free tissue transfer. Patients were managed instead on the head and neck ward. This retrospective case-note review aimed to report outcomes in consecutive patients treated before and during the pandemic, and to reflect on the implications of ward-based rather than HDU care. A total of 235 patients had free tissue transfer between 3 January 2019 and 25 February 2021: 125 before (lockdown 23 March 2020), and 110 during the pandemic (52 ward-managed and 58 HDU-managed). There were subtle case-mix differences during the pandemic, with 92% of ward-treated patients having oral cancers compared with 64% of HDU patients, and 73% of ward patients having a tracheostomy compared with 40% of HDU patients. Ward patients were less likely to receive electrolyte replacement (45% HDU vs 0% ward) and inotropes (12% HDU vs 2% ward). There were fewer returns to theatre for evacuation of a haematoma or re-anastomosis during the pandemic than there were before it. Other than fewer haematoma complications during the pandemic, the nature of complications was similar. In conclusion, the dramatic changes imposed by the pandemic have shown that the ward is a safe place for patients to be cared for immediately postoperatively, and it alleviates the bed pressures experienced in HDU. Careful case selection and clear criteria are required to identify patients who need the HDU.

Patients' views of physical activity whilst living with and beyond head and neck cancer.

Exercise is an important component of recovery following cancer. Head and neck cancer (HNC) patients typically report low levels of engagement in exercise initiatives. The aim of this study was to give insight into HNC patients' reflections on how and why they would be interested in participating in an exercise programme. A stratified sample of 51 patients based on age, gender and initial interest in an exercise programme was selected from 430 postal survey respondents. Twenty-five took part in a semi-structured telephone interview. There was responder bias with females, younger patients, and those already participating in or interested in an exercise programme being over-represented. The responders in this study highlighted issues related to physical activity levels, perceived ability to meet physical activity guidelines for cancer survivors, perceived exercise benefits, perceived exercise barriers, and advice to others diagnosed with cancer. The findings support the premise of personalized interventions tailored towards the specific needs of the patient, supported by patient peers to emphasize the benefits and help motivate patients to take part. In order to promote engagement in exercise there needs to be collaborative, culturally sensitive and individualized approaches, in order to address the specific barriers experienced by HNC patients.

Health related quality of life and patient concerns in patients with osteoradionecrosis.

The number of patients presenting with osteoradionecrosis (ORN) is likely to increase in future and health related quality of life (HRQOL) is a key outcome. This study aimed to report patient concerns and HRQOL in an osteoradionecrosis cohort over 12 years. Patients attended routine follow-up clinics between 2008 to 2020, where patient reported outcome (PRO) assessment was used before consultations as standard practice. The two PROs were the Patient Concerns Inventory (PCI) and the University of Washington quality of life questionnaire (UW-QOL v4). The study sample comprised 109 patients with ORN seen in 445 clinics when PCI and UW-QOL were used. At clinic, patients were in one of six ORN states: before ORN (26 with data), at diagnosis (12), and following treatment either improved (27), progressed (46), stable (63) or resolved (37). Worst HRQOL outcomes were reported in the progressive group with 50% reporting overall QOL as less than good. Pain was a major dysfunction (63%) as was physical and social-emotional functioning and this group reported many PCI issues, median (IQR) 7 (4-11). Kaplan-Meier estimates of survival with 95% CI after diagnosis with ORN were 96% (90-99%) at 12 months, 89% (81-94%) at 24 months and 73% (61-82%) at 60 months. This study indicates that ORN is a chronic condition with long-term survivorship consequences. More data through cohort studies and trials are needed to assist in decision making for individual patients.

Factors contributing to delayed decannulation of temporary tracheostomies following free tissue reconstructive surgery for head and neck cancer.

Temporary tracheostomies (TT) are performed to secure the airway perioperatively and postoperatively in head and neck cancer patients undergoing tumour resection and free tissue reconstructive surgery. Patients report that having a TT is unpleasant and they appreciate its removal at the earliest opportunity. Early removal not only improves patient satisfaction but should allow for a more rapid recovery. The aim of this prospective study was to assess factors that contribute to delays in decannulation following TT and hence to provide an insight into the factors that will support earlier decannulation when it is safe to do so. Consecutive patients who had TT over a six-month period were included. Delayed decannulation was defined as that after day seven postoperatively. There were 42 patients with a median (IQR) age of 70 (60-74) years, 26 of whom were men. The tracheostomy was surgical in 29 and percutaneous in 13. The median (IQR) time to decannulation was 4 (3-5) days (range 1-11 days). Seven patients had delayed removal (7-11 days), the reasons being hospital-acquired pneumonia (HAP) (n=4), prolonged stay in the high dependency unit (HDU) following postoperative myocardial infarction and cardiac arrest (n=1), failure to tolerate TT occlusion (n=1), and not stated (n=1). There were early postoperative complications in 14 patients but despite this seven decannulations were still performed within two and six days. Additional multiprofessional assessment over weekends is likely to facilitate earlier decannulation. As some TTs are removed after a few days there is a need for better selection to avoid their use in certain patients.

Head and neck cancer patients' recollection of their clinical characteristics.

Patient-reported outcomes (PRO) are an important component of treatment evaluation. Typically they are completed by patients on paper, but through advances in technology such as mobile phone apps and websites, there is a great opportunity for electronic completion. It can be challenging, particularly at a regional or national level, to maintain accurate core clinical records on head and neck cancer (HNC) (baseline, recurrence, second primary, and further treatment), and these will influence PROs and the reporting of outcomes. In addition, with data security and confidentiality there is merit in undertaking anonymous surveys, but in this approach, there is a reliance on patients' recall. The aim of this study therefore was to compare updated hospital records with details completed by patients. In January 2019, 395 HNC patients who had been treated in 2015 and 2016 were sent a survey. They were asked to recall the clinical variables of gender, age at diagnosis, tumour site, tumour stage, and primary treatment, and these were analysed for agreement with the hospital records. The kappa statistic (KP) was used to measure the strength of agreement for categorical variables. There were 146 responders and one patient correctly stated that they did not have cancer. Five indicated further disease rather than primary cancer. Agreement between the hospital record and patients' recall was excellent for gender (KP=0.97) and age group (KP=0.92), very good for treatment (KP=0.79), and good for site of cancer (KP=0.61), but poor for stage of cancer (KP=0.18). In general, patients gave accurate accounts of these details apart from tumour stage.

Administration of intravenous iron and tranexamic acid in the management of postoperative iron deficiency anaemia following free flap reconstruction: re-audit.

Following free tissue transfer, intravenous iron (IVI) has a role in reducing the rates of blood transfusion and more rapidly restoring haemoglobin (Hb) levels. Anaemia has a detrimental effect on survival, postoperative complications, fatigue, and health-related quality of life, therefore early correction is recommended. The aim of this re-audit is to assess the use of IVI, of tranexamic acid intraoperatively, and of perioperative blood transfusions. A total of 148 consecutive patients who underwent ablative surgery and free flap reconstruction between May 2018 and September 2019 were audited. The median (IQR) age was 66 (59,72) years and 36% were female. For two-thirds, surgery was for cancer located in the oral cavity and two-thirds of the free flaps were soft tissue. Tranexamic acid (TXA) was used intraoperatively for 30%, red blood cells (RBC) were transfused for 20% and 55 patients (37%) received IV iron. This compares with 4%, 26%, and 0, respectively, in the initial audit. Those having IVI were more likely (56%) to have had a composite flap, a lower postoperative haemoglobin and lower discharge Hb. The Hb between four and twelve weeks' follow up, known for 40, was a median (IQR) of 122 (104,138). There were no adverse reactions to IV iron. Although it is straightforward to administer IVI postoperatively, this re-audit demonstrates that it can be a challenge to embed change in protocols. Through raised awareness of the benefits of IVI, lack of adverse events and clarification of selection criteria, it is hoped that rates of IVI use will increase.

Clinical characteristics, treatment intent, and outcome in a consecutive 10-year cohort of oral cancer patients aged 75 years and older.

The prevalence of oral squamous cell carcinoma (OSCC) in the elderly is expected to increase by nearly a third in the next decade. Its management in older patients is potentially more challenging due to their pre-existing medical comorbidities, frailty, reduced life expectancy, and social issues. The aim of this retrospective review was to report on treatment given to patients aged 75 years and over, case mix, and survival. All patients aged 75 years and over who were diagnosed with OSCC in Merseyside between 1 January 2007 and 31 December 2016, and treated with either curative or palliative intent, were included. Their hospital notes were reviewed. Fisher's exact test and Kaplan-Meier analysis were used for data analysis. There were 236 patients (median (IQR) age 81 (78-86) years); 67% were treated curatively and 33% palliatively. Factors associated with palliation included older age, advanced tumour stage, cognitive impairment, and residence in a nursing or residential home. Of the 165 patients who were offered curative treatment, six (4%) declined due to personal or family reasons. Overall survival for palliative patients was 12% at one year and 7% at two years, whereas for patients treated curatively it was 74% at one year, 56% at two years, and 34% at five years. Patients over 85 years of age were less likely to have composite free flaps and postoperative radiotherapy. Perioperative mortality was 2.6%. Improvements in surgical techniques and perioperative management have enabled clinicians to offer treatment with curative intent to older frail patients, and with careful case selection outcomes can be very good.

Vibrational spectroscopic analysis of blood for diagnosis of infections and sepsis: a review of requirements for a rapid diagnostic test.

Infections and sepsis represent a growing global burden. There is a widespread clinical need for a rapid, high-throughput and sensitive technique for the diagnosis of infections and detection of invading pathogens and the presence of sepsis. Current diagnostic methods primarily consist of laboratory-based haematology, biochemistry and microbiology that are time consuming, labour- and resource-intensive, and prone to both false positive and false negative results. Current methods are insufficient for the increasing demands on healthcare systems, causing delays in diagnosis and initiation of treatment, due to the intrinsic time delay in sample preparation, measurement, and analysis. Vibrational spectroscopic techniques can overcome these limitations by providing a rapid, label-free and low-cost method for blood analysis, with limited sample preparation required, potentially revolutionising clinical diagnostics by producing actionable results that enable early diagnosis, leading to improved patient outcomes. This review will discuss the challenges associated with the diagnosis of infections and sepsis, primarily within the UK healthcare system. We will consider the clinical potential of spectroscopic point-of-care technologies to enable blood analysis in the primary-care setting.

Using the Patient Concerns Inventory in the identification of fatigue following treatment for head and neck cancer.

Fatigue has a profound impact on health-related quality of life (HRQOL). The aim of this study was to describe the clinical characteristics and HRQOL of head and neck cancer patients who raised the issue of fatigue on the Patient Concerns Inventory (PCI) at their review consultation. Eight consultants were randomized to use the PCI as part of a cluster-controlled trial. Patients also completed the University of Washington Quality of Life version 4 (UWQOL), EQ-5D-5L (EuroQol Group), and Distress Thermometer questionnaires. The study included 140 patients who attended clinics at a median of 108 (interquartile range 70-165) days after the end of treatment. The PCI item 'fatigue' was the sixth most commonly selected, by 29% (n=40). Those with advanced tumours were more likely to have selected the item (30/84, 36% vs 10/56, 18%; P=0.02), as were those treated with radiotherapy±chemotherapy (34/87, 39% vs 6/53, 11%; P<0.001). The PCI fatigue group reported significantly worse overall quality of life, social-emotional and physical function composite scores (UWQOL), Distress Thermometer, and EQ-5D-5L. PCI fatigue was common in those with sleeping, nausea, mood, depression, mobility, breathing, and energy level concerns. In conclusion, given the problems associated with fatigue, it is appropriate to screen and seek interventions that might help patients address this.

Using a patient prompt list to raise concerns in oncology clinics does not necessarily lead to longer consultations.

Head and neck oncology post-treatment consultations form a critical component of care in terms of support and surveillance. They occur frequently in the first few years and can place substantial demands on healthcare resources. However, they provide useful opportunities for patients to raise issues and receive tailored information and support. The aim of this paper was to assess whether completion of a 56-item patient prompt list (PCI - the Patient Concerns Inventory) immediately prior to the consultation significantly increased its duration. This was a pragmatic cluster preference randomised controlled trial of 288 patients with 15 consultant clusters from two sites "using" (n=8) or "not using" (n=7) the PCI. Consultation times were known for 283 patients (136 PCI, 147 non-PCI) who attended their first post-treatment trial consultation a median (IQR) of 103 (70-160) days after the end of treatment. Consultations lasted a median (IQR) of 10 (7-13) minutes (mean 11) in non-PCI patients and a median (IQR) of 11 (8-15) minutes (mean 12) in PCI patients (p=0.07). After adjustment for patient clustering and significant case mix, the 95% confidence interval for the mean difference was between 1.45minutes shorter with the PCI and 2.98minutes longer (p=0.50). There was significant variation in duration by consultant, tumour stage, treatment mode, overall quality of life (QoL), and distress (all p<0.001). In those who completed the PCI, duration increased with the total number of items selected (p<0.001). In conclusion, the inclusion of a prompt list to help facilitate conversation with patients did not make a substantial difference to consultation times.

Two-week rule: suspected head and neck cancer referrals from a general medical practice perspective.

The two-week rule (2WR) referral system was designed to fast-track patients with suspected malignancies to secondary care services to facilitate prompt investigation and management, the ultimate goals being early detection and improved survival. Patients with symptoms of head and neck cancer primarily present to the general practitioner (GP) who has an important role in the identification of high-risk patients for prompt management. This paper reports urgent 2WR referrals from primary care to highlight difficulties in the referral process. Data were collected from three GP practices (16 GPs) in Merseyside that all used the EMIS Web system (EMIS Health). All patients who were referred on the 2WR pathway in a two-year period from January 2017 were identified (n=113). The conversion rate for malignant diagnosis was 5.5% (95% CI: 2.0 to 11.5%). Those with multiple symptoms had a higher rate of malignancy (16%, 3/19) than those with a single symptom (3%, 3/91) (p=0.06). In total, 76% of patients had had no treatment before referral. The duration of symptoms ranged from 1 - 208 weeks (median (IQR) 6 (4-12) weeks). Common benign symptoms included laryngopharyngeal reflux (n=27), thyroid lesion (n=9), and neck lymph node (n=7). The diagnosis of head and neck cancer in primary care is challenging. Initiatives to try to increase the cancer conversion rate are required, but they run the risk of missed diagnosis and increased delay. Sufficient resources are needed in secondary care to ensure the timely assessment of patients who are referred on the 2WR pathway.

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.

Loneliness and quality of life after head and neck cancer.

Loneliness is associated with a poor quality of life, mental illness, poor physical health, and premature mortality. Patients with head and neck cancer (HNC) are at risk of loneliness because of the effects of the disease and its treatment on important social interactive functions such as appearance, speech, facial expression, and eating. Patients treated for primary squamous cell HNC between January 2015 and December 2016 were surveyed in early 2019 using the University of Washington quality of life questionnaire version 4, the Cancer-related Loneliness Assessment Tool (C-LAT), and four nationally recommended indicator questions. The survey comprised 140 patients, with a mean (standard deviation) age at diagnosis of 63 (11) years. Tumour sites were oropharyngeal (42%), oral (35%), laryngeal (14%), and elsewhere (9%). In response to the question "How often do you feel lonely?" three-quarters said "hardly ever" and only 6% "often". Similar responses were obtained for the other three indicator questions. It is encouraging that a relatively small proportion had serious issues with loneliness. Similarly, responses to the C-LAT suggested that one-quarter had feelings of loneliness and a minority had serious problems. Patients who were younger, who lived in more deprived circumstances, who had advanced disease and had been treated with chemotherapy or radiotherapy reported greater levels of loneliness. Loneliness was associated with a worse overall quality of life, and worse physical and social-emotional function. Lonely patients need to be identified as early as possible so that support and interventions can be implemented and outcomes improved.