Search

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.

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.

Across England the NHS (National Health Service) has set in place a national survey that invites cancer patients to report their quality of life around 18 months after their diagnosis. The two questionnaires are the EQ-5D-5L and EORTC C30. For head and neck cancer (HNC) several factors will affect patients' characteristics and response rates at the 18-month window. There were three aims of this study: to account for drop-out over the first 18 months, to report the characteristics of responders in comparison with the whole cohort, and to summarise the health-related quality of life (HRQoL) outcomes (EQ-5D-5L and EORTC QLQ-C30). Patients treated with curative intent who were cancer-free at 15 months were sent a postal survey 16 months after diagnosis, with a second reminder at 18 months. Of the 256 patients analysed, 187 were alive at the 15-month follow-up window, 20 of whom were living with recurrence. Survival was related to tumour stage, treatment intent, and mode of treatment. A total of 109 (67%) responded and the response rate was better from older patients. Older patients reported better HRQoL across all measures apart from EQ-5D-5L mobility and EORTC physical functioning, while patients living in more deprived neighbourhoods reported worse HRQoL across all measures apart from loss of appetite. Other than a tendency for a worse HRQoL in patients having surgery with free-flap transfer, there were no obvious consistent differences by tumour stage, site, or treatment. In conclusion, when reflecting on the findings of the National QoL Metric (QoLM) in HNC, it will be important to consider the influence of survivorship and response rates.

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.

Introduction Head and neck cancer (HNC) patients should receive a dental assessment at an appropriate time before commencing radiotherapy (RT), to prevent complications such as osteoradionecrosis (ORN) if extractions are required. A recent orthopantomogram radiograph (OPG) is part of this assessment.Aim To compare the delivery of pre-RT dental assessment at the Regional Oncology Centre against national guidelines in regard to OPG assessments and timing of extractions.Materials and methods A consecutive cohort of patients treated curatively were selected within two timeframes (January to March 2018 and January to March 2019) using multidisciplinary team records at Liverpool University Hospital. Patient notes, x-ray images and records were examined.Results In total, 145 patients were identified. Eighty-nine percent (129) had an OPG radiograph and 72% (104) had a pre-RT dental assessment. Oral and laryngeal sites had the highest number of missed assessments. Altogether, 54 patients had dental treatment, with 47 undergoing extractions. Extractions were completed a median 13 days before RT started. By November 2020, no patients had been diagnosed with ORN.Conclusions Three-quarters of patients received a pre-RT assessment but there is scope for improvement. OPGs should be part of initial HNC staging and referral to Regional Oncology Centre dental services should be made as part of the pre-RT workup.

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. Supplementary Information The online version contains supplementary material available at 10.1007/s41669-021-00320-4.

The influence of area-based and individual indicators of socioeconomic status (SES) on health-related quality of life (HRQOL) and patient concerns following head and neck cancer is complex and under-reported. The aim of this study is to use baseline data collected as part of a randomised controlled trial to provide greater detail on the attribution of SES to University of Washington Quality of Life version 4 (UWQOL v4), Distress Thermometer and European Quality of Life Five-Dimension Five-Level (EQ-5D-5L) outcomes. A total of 288 trial patients attended baseline clinics a median (Interquartile (IQR)) of 103 (71–162) days after the end of treatment. Area-based SES was assessed using the Index of Multiple Deprivation (IMD) 2019. Thirty-eight per cent (110/288) of patients lived in the most deprived IMD rank quintile. Less than good overall quality of life (31% overall) was associated with current working situation (p = 0.008), receipt of financial benefits (p &lt, 0.001), total household income (p = 0.003) and use of tobacco (p = 0.001). Income and employment were significant patient level indicators predictors of HRQOL outcomes after case-mix adjustment. The number of Patient Concerns Inventory items selected varied significantly by overall clinical tumour clinical stage (p &lt, 0.001) and by treatment (p &lt, 0.001) but not by area IMD or patient-level deprivation indicators. In conclusion, interventions to improve employment and finance could make a substantial positive effect on HRQOL outcomes and concerns.

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

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.

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.

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. Postprint

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.

Objective The aim of this study was to report 10-year health-related quality of life (HRQOL) outcomes after treatment of oral squamous cell carcinoma (OSCC). Study Design Cross-sectional HRQOL surveys collated over a 13-year period for patients treated from 1992 yielded a cohort of 674 patients with OSCC who had undergone treatment with curative intent. HRQOL closest to 2 and 10 years was measured by using the University of Washington Quality of Life (UW-QOL) questionnaire. Results UW-QOL data were available for 67% (154) of 230 patients alive at 10 years. Three-quarters reported their overall quality of life (QOL) as good, very good, or outstanding. Free-flap surgery was the strongest predictor of overall QOL being less than good at 10 years. A significant problem or dysfunction, ranging from 7% to 13% across the 12 UW-QOL domains, was reported by a minority of patients. At the group level, the changes from 2 years to 10 years were minimal, with some improvement observed in appearance, chewing, mood and anxiety, and deterioration in swallowing. There was considerable scatter in individual changes over time. Conclusions At the group level, HRQOL at 10 years was similar to that at 2 years; however, at the individual-patient level, the domains were not so stable.

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.

Objectives To determine the organisational resources in place; what blood was being transfused, why, how, where, when and by whom; whether laboratory support and policies met standards for patients with sickle cell disease (SCD). Background SCD affects 14 000 people in the United Kingdom (UK). Standards and guidelines do not cover all aspects of transfusion in SCD and there are no data on their use; people may become very sick without warning presenting to non-specialist hospitals; blood services are increasingly supplying units for transfusion in SCD with little data on their use. Methods A retrospective audit of transfusion services/practice for people with SCD who had received a transfusion in January-July 2014 in participating hospitals in the UK and Republic of Ireland (ROI). Results Eighty-four hospitals submitted 1290 cases, 75% of cases came from 18 hospitals submitting 25 or more cases. Transfusions (91.2% [1164/1276]) were administered to patients with HbSS, 60% (732/1227) of patients needed Rh CE negative blood. Transfusion episodes (4528) were recorded, of which 84% were elective. Stroke prevention accounted for 42% of all transfusions; adults received 56% of transfusions of which 50% were automated red cell exchange (RCE), children received 44% of transfusions of which 87% were simple transfusions. Conclusions There was a paucity of appropriate clinical management protocols, adequately trained staff and network arrangements. The high numbers of children being transfused, disparity in transfusion modality between children and adults and the high frequency of the CE negative Rh phenotype were noted.

After their initial presentation of oral squamous cell carcinoma (SCC), patients have a lifelong risk of developing another new SCC of the head and neck. The aim of this study was to establish second primary rates, baseline characteristics (site, clinical or pathological stage, and smoking and alcohol history), timing, presentation, treatment, and outcomes. From the regional unit we analysed records of patients treated with curative intent for their first oral cancer between 2002 and 2007 inclusive. All patients had had at least 10 years of follow up either to death or the end of 2017. A total of 347 patients had been treated with curative intent, and of them, 29 had a second primary at a median (IQR) of 52 (30-79) months after the index operation. The incidence of developing a second primary tumour within two years was 1.7% (95% CI: 0.7% to 3.7%), within five years was 4.9% (95% CI: 2.9% to 7.7%), and within 10 years was 7.8% (95% CI: 5.1% to 11.1%). Early stage of first cancer was the only significant factor (p = 0.001) for development of a second primary within 10 years, reflecting survivorship. Most second primaries (21 patients) were staged as early, and by visual inspection. Most (n = 20) were within the oral cavity, one of which overlapped the oropharynx; eight others were in the oropharynx, and one in the larynx. Most patients (n = 22) were treated by operation with curative intent. Three were treated palliatively. Patients need to be aware of the risk of a second primary and, as most are in the mouth or oropharynx, there is a role for surveillance by primary dental care practitioners.

Purpose The maxillectomy defect is complex and the best means to achieve optimal reconstruction, and dental rehabilitation is a source of debate. The refinements in zygomatic implant techniques have altered the means and speed by which rehabilitation can be achieved and has also influenced the choice regarding ideal flap reconstruction. The aim of this study is to report on how the method of reconstruction and oral rehabilitation of the maxilla has changed since 1994 in our Institution, and to reflect on case mix and survival. Methods Consecutive head and neck oncology cases involving maxillary resections over a 27-year period between January 1994 and November 2020 were identified from hospital records and previous studies. Case note review focussed on clinical characteristics, reconstruction, prosthetic rehabilitation, and survival. Results There were 186 patients and the tumour sites were: alveolus for 56% (104), hard palate for 19% (35), maxillary sinus for 18% (34) and nasal for 7% (13). 52% (97) were Brown class 2 defects. Forty-five patients were managed by obturation and 78% (142/183) had free tissue transfer. The main flaps used were radial (52), anterolateral thigh (27), DCIA (22), scapula (13) and fibula (11). There were significant changes over time regarding reconstruction type, use of primary implants, type of dental restoration, and length of hospital stay. Overall survival after 24 months was 64% (SE 4%) and after 60 months was 42% (SE 4%). Conclusion These data reflect a shift in the reconstruction of the maxillary defect afforded by the utilisation of zygomatic implants.

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.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).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.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.

Introduction Patient worry and concern of cancer adds to the latent distress associated with referral on the two-week suspected pathway (2WW). For oral cancer, as the conversion rate is in the region of 5-10%, the majority of people will have needless cause for concern.Aim This study aims to report how worried/concerned patients were that the reason for referral might mean that they had cancer and to relate to referral characteristics.Materials/methods All patients referred on the 2WW to two oral and maxillofacial departments in the three months from January to March 2021 were sent a one-off anonymised study-specific post-consultation survey.Results In total, 107 of 353 patients responded to the survey (30%). The response rate increased notably in the older group (p0.001). The cancer conversion rate overall was 5.4% (19/353), stratified as 2.4% (4/167) for general dental practitioner and 8.1% (15/186) for general medical practitioner (p = 0.02). When asked how worried/concerned they were that the reason for referral might have been for cancer, the response was 'very much' (34%, 33/98), and 'somewhat' (24%, 24/98). Concerns tended to be higher in women and those under 40.Conclusions In recognition of the proportion of patients on the 2WW pathway without cancer who have 'very much worry and concern', it is appropriate to explore ways to alleviate this anxiety, and the best means to achieve this needs careful consideration.

Background The zygomatic implant perforated (ZIP) flap technique provides immediate reconstruction and rapid dental rehabilitation for low-level malignant tumors. Methods Patients who underwent ZIP flap reconstruction between December 2015 and February 2021 were followed prospectively. Results Thirty-five consecutively treated patients were studied with 16 undergoing surgery alone and 19 undergoing surgery followed by radiotherapy. The median time to fit the prosthesis was 29 days with all patients requiring adjuvant radiotherapy receiving their fixed dental prosthesis prior to its commencement. Vascularized flap (100%), zygomatic implant (98.4%), and prosthesis (97%) survival were excellent and the ZIP flap protocol was highly rated by patient-related outcome measures especially for the chewing domain. Conclusions The ZIP flap technique provides an excellent means of providing an autogenous oronasal seal and a foundation for immediate cortically anchored fixed dental rehabilitation. Clinical significance This technique provides rapid and robust rehabilitation for patients presenting with low-level maxillary malignancy despite the use of radiotherapy.

Background: Fear of cancer recurrence (FCR) is recognized as a common concern for patients with head and neck cancer (HNC). The aim of this study is to describe in greater detail the demographic and clinical characteristics of HCN patients who indicate a high level of FCR in their review consultation.Methods: A pragmatic cluster-controlled trial was conducted between January 2017 and December 2018 at two UK HNC centers (Leeds and Liverpool) to test the efficacy of a prompt tool called the Patient Concerns Inventory (PCI). Patients completed the PCI and the UW-QOLv4 which included a single 5 category rating of FCR. Secondary statistical analyses focused on variables associated with high FCR.Results: Two hundred and eighty-eight trial patients were recruited in this trial. At a median of 194 days after diagnosis and 103 days after the end of treatment 8% stated (n = 24) “I get a lot of fears of recurrence and these can really preoccupy my thoughts” and 3% (n = 8) “I am fearful all the time that my cancer might return, and I struggle with this.” Thus, 11% (n = 32) responded in the worst two categories, 95% Confidence interval 7.7–15.3% for high FCR. Stepwise logistic regression resulted in female gender (p < 0.001), age (p = 0.007), and receiving financial benefits (p = 0.01) as independent predictors.Conclusions: Around one in ten HNC patients attending routine outpatient follow-up consultations report high FCR, however for female patients under the age of 55 the rate was one in three. This group requires specialist attention and could be the focus of a multicenter intervention trial.

The ability of patients to participate in recreational activities is an important facet of health-related quality of life (HRQoL) after treatment for cancer of the head and neck. The aim of this study was to analyse patients' responses to the activity and recreation domains of the University of Washington quality of life questionnaire (UW-QoL), and to relate them to clinical characteristics, the intensity of leisure-time exercise/week, perceived barriers that interfere with exercise, and feeling able to participate in an exercise programme. Other questionnaires used were the Godin Leisure-Time Exercise questionnaire, the Perceived Exercise Barriers questionnaire, and the Exercise Preferences questionnaire. The survey sample comprised 1021 patients of whom 437 responded (43%). Of them, 9% reported a serious problem with activity and 8% with recreation. The main influencing factors were site (oropharynx), advanced stage, radiotherapy and chemotherapy, composite flap, gastrostomy tube, and coexisting conditions. Low (worse) scores in the UW-QoL activity and recreation domains were associated with little time spent exercising, low-intensity exercise, more barriers to exercising, and a lack of preference. The use of the UW-QoL in follow-up assessments can help to identify patients who are having difficulties in these two domains, as well as those who feel able to participate in an exercise programme. Further research is required to optimise the interventions that will promote exercise and improve recovery and wellbeing.

Purpose Head and neck cancer (HNC) patients may experience fears regarding cancer recurrence (FoR) and of catching COVID-19. There could be unease for attending hospital clinics for face to face (F2F) examination. F2F benefit in cancer surveillance has to be balanced against the risk of virus transmission. This study aimed to report perceptions of fear of cancer and fear of COVID-19 and to report patient preference for follow-up consultation in HNC survivors during the COVID-19 pandemic. Methods The study ran from lockdown in England on 24th March to 29th July 2020. Patients were offered preference to postpone their consultation, to have it by telephone, or F2F. A postal survey was undertaken in the 2 weeks post-consultation (actual or postponed). Results There were 103 patients. Initial action by consultant and patient resulted in 51 postponed consultations, 35 telephone consultations and 17 F2F meetings, with 10 F2F triggered by the patient. There were 58 responders to the survey and most (39) had a clear preference for one mode of follow-up consultation during the COVID-19 pandemic, with half (19) preferring F2F. A similar response was seen regarding their consultations in general to address unmet needs and concerns, with 38 having a preferred mode, 29 preferring F2F. Serious fears about recurrence and COVID-19 were at relatively low levels with a tendency to be more concerned about recurrence. Conclusion Any redesign of mode and frequency of out-patient follow-up in light of COVID-19 should be undertaken in discussion with patient groups and with individual patients.

Introduction and Objectives Severe coronavirus 19 disease (COVID 19) has rapidly emerged as a global health threat and, despite considerable advances, outcomes remain poor in many patients. Published data infers considerable heterogeneity, with 80% suffering minimal symptoms but a minority developing life-threatening disease. COVID 19 trials to-date have been necessarily broad but the emergence of established therapies (e.g. Dexamethasone) and distinct phenotypes (e.g. immune activated, prothrombotic) suggests that early stratification to licensed or trial agents might result in improved outcomes. The ASTERIX study aims to define disease endotypes, based on baseline biological signatures associated with COVID-19 pneumonia, development of respiratory failure and death, which could be targeted in future trials. Methods >6,000 samples of blood, urine and respiratory secretions were collected and banked during the first wave of the COVID 19 pandemic in Glasgow. The cohort is organised into Tiers 0, 1 & 2 with each tier having an increasing number of samples available for downstream translational research. All tiers have the same associated comprehensive clinical data including comorbidity, ethnicity, blood results, imaging, prescription data and outcomes, including critical care support and survival. Results Tier 0 contains 1,512 cases, Tier 1 (defined by having at least one surplus sample banked for downstream assays) contains ~1000 cases. Tier 2 (defined as having matched samples of serum, plasma and a buffy coat) contains 421 cases. Sample collation and data analysis is ongoing but preliminary review indicates a mortality rate of 29%, which is consistent with that reported in UK-wide COVID 19 series. The project team have made extensive links with collaborators and a scientific review board has been convened. The following projects are at various stages of approval and delivery: (1) Host Epigenomics (2) Host Proteomics (3) Host Metabolomics (4) miRNA Outcome Signatures (5) Host Respiratory Microbiome (6) COVID 19 Coagulopathy. Conclusions Data and banked samples will be used to develop endotypes (biological signatures derived from statistical models) associated with progression to key clinical outcomes. This information will be used to identify high-risk cohorts that could be targeted in future studies testing suitable interventions, as directed by the content of each signature.

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.

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.

OBJECTIVES:There is controversy regarding surgical margins in the management of early oral squamous cell carcinoma (OSCC). The main objectives of this study were to assess the: relevance of the margin independent of tumour variables; threshold for a safe margin; relevance of dysplasia at the margin. MATERIALS & METHODS:UK based retrospective multicenter cohort study of patients with previously untreated and clinically early OSCC between 1998 and 2016. All patients had surgery as the primary modality and had surgical staging of the neck. Minimum follow-up was 2 years. Margins were classified as: clear ≥5.0 mm; close 1.0-4.9 mm; involved not cut-through (INC-T) 0.1-0.9 mm; cut-through (C-T) 0 mm. RESULTS:669 patients were included. After adjusting for tumour variables Cox multivariate regression analysis demonstrated that close margins had similar survival outcomes to clear margins (Hazard Ratio(HR) 0.99 (95%CI 0.50-1.95) for Local Recurrence Free Survival (LRFS); HR 1.08 (95%CI 0.7-1.66) for Disease Free Survival (DFS); HR 0.74 (95%CI 0.44-1.25) for Disease Specific Survival (DSS); HR 0.80 (95%CI 0.58-1.11) for Overall Survival (OS)). C-T margins had significantly worse LRFS (HR 5.01 (95%CI 2.02-12.39)) and DFS (HR 2.58 (95%CI 1.28-5.20)). INC-T margins had significantly worse DFS (HR 1.98 (95% CI 1.01-3.87)). Time dependent receiver operating characteristic curve analysis did not demonstrate a clear margin threshold for LRFS within 24 months (AUC = 0.53 (95%CI 0.41-0.64)). Dysplasia at the margin did not influence LRFS or DFS. CONCLUSION:Only resection margins

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 1.45 minutes shorter with the PCI and 2.98 minutes 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

The aim of this paper is to report the clinical characteristic of those patients reporting "I have too much saliva" following treatment for head and neck cancer. As a new addition to the saliva question of the University of Washington quality of life questionnaire (UW-QoL), another aim is to make recommendations on how this new option should be scored and handled. Patients treated with curative intent were recruited between April 2017 and October 2019. Assessment was at the first baseline clinic a median (IQR) of 194 (125-249) days after diagnosis and 103 (71-162) days after the end of treatment. Patients completed the modified UW-QoL version 4, the Patient Concerns Inventory (PCI), Distress Thermometer, and the EQ-5D-5L. In 288 patients, saliva was of normal consistency for 80 (28%), less than normal but enough for 57 (20%), too little for 91 (32%), too much for 45 (16%), and there was no saliva at all for 15 (5%). Of patients with too much saliva, two-thirds (31/45, 69%) had tumours located in the oral cavity and 18/40 (45%) had the highest rates of free flap use during surgery. Salivation response was associated strongly with the other measures of health-related quality of life (HRQoL) and the PCI. Of those with too much saliva their results were similar to or worse than those with too little or no saliva at all. In conclusion, having too much saliva is relatively less frequently reported but is an important HRQoL consideration. Its scoring in the UW-QoL should be at a level similar to that of too little saliva.

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.

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.

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.

Rates of head and neck cancer are high in patients with a low socioeconomic status (SES) and outcomes are often poor. The degree to which people from different socioeconomic groups use the fast-track, two-week suspected cancer referral system is, however, unclear. The aim of this audit was therefore to analyse these referrals with reference to SES, and to focus on differences in clinical characteristics, source of referral, and rates of disease. The sample included all patients who were referred to the head and neck department at an inner-city hospital in the northwest of England between July and September 2017. According to the Index of Multiple Deprivation (IMD), most (62%) of them lived in the most deprived quintile. A total of 390 referrals were analysed of which 60% were female, 53% were under 60 years of age, 33% smoked, and 69% consumed fewer than 10 units of alcohol/week. Only 24 were referred by dentists, but these accounted for almost one quarter of those referred to maxillofacial surgery. Common symptoms included a swelling or lump (n = 153, 39%), hoarseness (n = 101, 26%), ulcer (n = 29, 7%), and sore throat (n = 23, 6%). Forty-five per cent were referred with other symptoms. A total of 28 (7%) were diagnosed with cancer of the head and neck. Rates were higher in patients referred by dentists (p = 0.02) and in those who drank more alcohol (p = 0.02). The positive predictive value was higher in the least deprived (17%) than in the most deprived (6%). In primary care, more education that is aimed specifically at people of lower SES might reduce the number of “worried well” and lessen the pressure on departments to achieve the two-week target.

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 PDF

Introduction The National Institute for Health and Care Excellence guidance Improving Supportive and Palliative Care for Adults with Cancer (2004) and the Cancer Reform Strategy (2007) support the premise that assessment and discussion of patients’ needs for physical, social, psychological, and spiritual wellbeing should be undertaken during oncology follow-up. We report the use of the Patient Concerns Inventory in a routine head and neck cancer clinic setting over a seven-year period, summarising the number of available clinics, the number of patients completing the inventory within a clinic, the range of clinical characteristics and the concerns they wanted to discuss. Methods The data were analysed from oncology follow-up clinics between 1 August 2007 and 10 December 2014. Audit approval was given by the Clinical Audit Department, University Hospital Aintree. Results There were 386 patients with 1198 inventories completed at 220 clinics, median 6 (range 4–7) per clinic. The most common concerns raised by patients across all the clinic consultations were dry mouth (34%), fear of recurrence (33%), sore mouth (26%), dental health (25%), chewing (22%) and fatigue/tiredness (21%). Conclusions The incorporation of the Patient Concerns Inventory as part of routine oncology clinics allows for a more patient initiated and focused consultation available to the majority of patients throughout their follow-up. The inventory allows for greater opportunity to provide holistic targeted multiprofessional intervention and support.

The head and neck cancer Patient Concerns Inventory (PCI-HN) is a holistic, self-reported list of items that can help patients to disclose their needs and concerns during routine follow-up consultations. The aim of this study was to report how often it was used during the first three years of follow up after treatment for oral cancer, and the range of issues that were raised. The sample comprised consecutive patients treated over a three-year period with curative intent. All clinic attendances were reviewed until October 2015 or until patients had a recurrence, a subsequent primary, metastases, or were discharged home or to follow up at a peripheral hospital, or started palliative care. We identified 92 patients and data were available for 88 of them. The median (IQR) age at the time of treatment was 65 (57-76) years, and 48 (55%) were men. Reviews alternated between the surgeon and oncologist, and typically there were 4.4 surgical reviews in year one, 2.8 in year two, and 1.6 in year three. The inventory was completed 157 times; at least once by 71% (55/77) during year one, 57% (29/51) during year two, and 37% (13/35) during year three. Of those who completed none, nearly half (7/17) died within 12 months, and another six were over 80 years of age. In conclusion, the diversity of concerns raised by patients highlights the need for holistic assessment during follow up, and integration of the inventory into routine consultations will mean that we can repeat it.

Regular monitoring of free flaps is essential after microvascular free tissue transfer, but the frequency and duration of the observations vary between units and there is no consensus nationally. Best practice can be informed by the feedback of patients, but as we know of no such studies, we did a cross-sectional survey of a consecutive group of patients after free tissue transfer to find out what they thought about monitoring. We designed a study-specific questionnaire after consultation with the patient and carer forum, and sent it to 150 patients who had had free tissue transfer in the maxillofacial department at Aintree University Hospital during 2015 and 2016. A total of 106 (71%) responded, and a quarter (30/106, 28%) would have liked more information about monitoring. Generally, patients were worried little by the observations (91/106, 86%), but one-third (34/106, 32%) reported disturbed sleep. Just over half (n = 55/104, 53%) were relieved when the monitoring changed from hourly to four-hourly, and almost all (99/101, 98%) were not worried by this. Nearly half (47/105, 45%) would have preferred fewer observations when asleep. In conclusion, our findings could help to inform a leaflet for patients about monitoring. Consideration could be given to reducing its frequency, for example, the checks at 1, 3, and 5 am could be omitted during the second night, which could make a substantial difference to the patient. However, its impact on salvage needs to be audited.

Background Head and neck cancer (HNC) patient concerns inventory (PCI) is a condition-specific prompt list that allows patients to raise concerns that might be overlooked. To our knowledge, this is the first economic evaluation of PCI in patients with HNC from a UK National Health Service (NHS) perspective, exploring the cost-effectiveness of the PCI in the treatment of patients with HNC. To triangulate our economic evaluation, we conducted qualitative interviews with a sample of consultants providing care. Methods Alongside a 3-year cluster-randomised controlled trial, we undertook an economic evaluation. The trial start date was April 1, 2017, and it closed on June 30, 2020, while the health economic evaluation commenced in September, 2020. Client Service Receipt Inventory data were collected twice during the trial period, at 6 and 12 months after baseline. Patients were identified by a multidisciplinary team at the trial clinics. This economic analysis compared the PCI intervention (PCI group) with the non-PCI treatment pathway (non-PCI group). We did a probabilistic sensitivity analysis to investigate the cost per quality-adjusted life-year (QALY) gain of the intervention. We also collected qualitative data from seven consultants to corroborate study findings. Findings Our economic model used data from 90 patients in the PCI intervention group and 101 patients in the non-PCI group. The PCI group had 62% male participants while the non-PCI group had 74% male participants. In both groups over 95% of the participants were white British patients . The PCI inventory was low cost at just over £13 per participant. The PCI intervention was cost-effective and 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 group (with a value of 0·79) than in the non-PCI group (with a value of 0·76) . The sensitivity analysis showed that at a Willingness to Pay threshold of £20 000, the PCI intervention had a probability of being cost-effective of 0·85 (95% CI 0·80–0·83). The qualitative results showed that consultants using the PCI reported an enhanced awareness of patients' overall post-treatment needs. Interpretation The PCI provided an effective means to conduct the clinical consultations by avoiding unnecessary health-care costs and focusing 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 PCI is a low-cost intervention that generates a cost-effective benefit to patients from an NHS perspective if rolled out as part of routine care. Funding National Institute for Health Research.

Objectives The aim of this study was to assess current practices around obtaining consent for blood transfusion and provision of patient information in hospitals across the UK and identify areas for improvement. Background Recommendations from the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) (2011) state that valid consent should be obtained for blood transfusion and documented in clinical records. A standardised source of information should be available to patients. Practices in relation to this have historically been inconsistent. Methods The consent process was studied in hospitals across the UK over a 3-month period in 2014 by means of an audit of case notes and simultaneous surveys of patients and staff. Results In total, 2784 transfusion episodes were reviewed across 164 hospital sites. 85% of sites had a policy on consent for transfusion. Consent was documented in 43% of case notes. 68% of patients recalled being given information on benefits of transfusion, 38% on risks and 8% on alternatives and 28% reported receiving an information leaflet. In total, 85% of staff stated they had explained the reason for transfusion, but only 65% had documented this. 41% of staff had received training specifically on transfusion consent in the last 2 years. Conclusions There is a need to improve clinical practice in obtaining valid consent for transfusion in line with existing national guidelines and local Trust policies, with emphasis on documentation within clinical records. Provision of patient information is an area particularly highlighted for action, and transfusion training for clinicians should be strengthened.