Consequences of how third sector organisations are commissioned in the NHS and local authorities in England: a mixed-methods study.

Background: As a matter of policy, voluntary, community and social enterprises contribute substantially to the English health and care system. Few studies explain how the National Health Service and local authorities commission them, what outputs result, what contexts influence these outcomes and what differentiates this kind of commissioning. Objectives: To explain how voluntary, community and social enterprises are commissioned, the consequences, what barriers both parties face and what absorptive capacities they need. Design: Observational mixed-methods realist analysis: exploratory scoping, cross-sectional analysis of National Health Service Clinical Commissioning Group spending on voluntary, community and social enterprises, systematic comparison of case studies, action learning. Social prescribing, learning disability support and end-of-life care were tracers. Setting: Maximum-variety sample of six English local health and care economies, 2019-23. Participants: Commissioning staff; voluntary, community and social enterprise members. Interventions: None; observational study. Main outcome measures: How the consequences of commissioning compared with the original aims of the commissioners and the voluntary, community and social enterprises: predominantly qualitative (non-measurable) outcomes. Data sources: Data sources were: 189 interviews, 58 policy and position papers, 37 items of rapportage, 692,659 Clinical Commissioning Group invoices, 102 Freedom of Information enquiries, 131 survey responses, 18 local project group meetings, 4 national action learning set meetings. Data collected in England during 2019-23. Results: Two modes of commissioning operated in parallel. Commodified commissioning relied on creating a principal-agent relationship between commissioner and the voluntary, community and social enterprises, on formal competitive selection ('procurement') of providers. Collaborative commissioning relied on 'embedded' interorganisational relationships, mutual recognition of resource dependencies, a negotiated division of labour between organisations, and control through persuasion. Commissioners and voluntary, community and social enterprises often worked around the procurement regulations. Both modes were present everywhere but the balance depended inter alia on the number and size of voluntary, community and social enterprises in each locality, their past commissioning experience, the character of the tracer activity, and the level of deprivation and the geographic dispersal of the populations served. The COVID-19 pandemic produced a shift towards collaborative commissioning. Voluntary, community and social enterprises were not always funded at the full cost of their activity. Integrated Care System formation temporarily disrupted local co-commissioning networks but offered a longer-term prospect of greater voluntary, community and social enterprise influence on co-commissioning. To develop absorptive capacity, commissioners needed stronger managerial and communication capabilities, and voluntary, community and social enterprises needed greater capability to evidence what outcomes their proposals would deliver. Limitations: Published data quality limited the spending profile accuracy, which did not include local authority commissioning. Case studies did not cover London, and focused on three tracer activities. Absorptive capacity survey was not a random sample. Conclusions: The two modes of commissioning sometimes conflicted. Workarounds arose from organisations' embeddedness and collaboration, which the procurement regulations often disrupted. Commissioning activity at below its full cost appears unsustainable. Future work: Spending profiles of local authority commissioning; analysis of commissioning in London and of activities besides the present tracers. Analysis of absorptive capacity and its consequences, adjusting the concept for application to voluntary, community and social enterprises. Comparison with other health systems' commissioning of voluntary, community and social enterprises. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR128107) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 39. See the NIHR Funding and Awards website for further award information.

National Health Service commissioners and local councils often buy health and care services from voluntary, community and social enterprises. This study aimed to explore how commissioners and voluntary, community and social enterprises worked together and where improvements could be made. We talked to commissioners and voluntary, community and social enterprises in six areas across England and focused on services for learning disabilities, social prescribing and end-of-life care. We analysed National Health Service financial accounts to see how much the National Health Service was spending on services provided by voluntary, community and social enterprises. We surveyed how commissioners and voluntary, community and social enterprises were using information and knowledge to make decisions. We organised events bringing together commissioners and voluntary, community and social enterprises to share knowledge and experience. We found there were two ways commissioners bought services from voluntary, community and social enterprises. One was commodified (a buying-and-selling model), the other collaborative (based on working together). Both were happening at the same time in all the areas of the study, but usually one of them was more present than the other. We saw a general move towards collaboration, but some areas were further along with this than others. Various things helped commissioners and voluntary, community and social enterprises collaborate, such as: paying voluntary, community and social enterprises enough for their services; having people and networks that encouraged others to work with voluntary, community and social enterprises; and including voluntary, community and social enterprises in making decisions about health and care. Commissioners and voluntary, community and social enterprises might therefore lean further towards working together to see how collaborative commissioning can be further developed; how to make contract prices cover voluntary, community and social enterprises' costs; how to enable longer-term contracts; and how to enable less hurried, more considered ways of renewing contracts (e.g. by putting draft contract specifications out to pre-tender consultation). The new Integrated Care Systems in local areas could encourage all this to happen, but pressures elsewhere in the health and care sector might make it more difficult.

Acceptance and willingness of patients with chronic facial nerve palsy for an implantable device that assists with eye closure.

BACKGROUND: Patients with facial nerve palsy often experience lagophthalmos (incomplete eye closure), which can lead to exposure keratitis. The Bionic Lid Implant for Natural Eye Closure (BLINC) is a medical device designed to mimic the more natural blink kinetics than traditional lid loading techniques. AIMS: This study aimed to evaluate potential factors that might influence the design of the BLINC device and willingness of participant to undergo the implant placement surgery. METHODS: Patients attending a multidisciplinary facial nerve clinic were invited to complete a survey addressing patient acceptance of the BLINC device implantation. RESULTS: Seventy-two patients were mailed the survey, of which 50 returned completed surveys (69%). The most important factor identified by participants was the device function (81% ranked as very important) and the least important factor was cost (16% ranked as very important). Median acceptable device function time was 5 years (range 1-10 years). Ten participants (20%) indicated willingness to be the first to trial BLINC. Women were more likely to rate visual appearance as important (OR 3.32, CI 1.14-9.62, p = 0.028), and less likely to rate user friendliness as important (OR 0.16, CI 0.04-0.52, p = 0.0021). Older participants were more likely to rate the length of recovery period as important (OR 1.04, CI 1.01-1.08, p = 0.006). Participants with complete eye closure were less likely to be willing to trial the implant (OR 0.08, CI 0.00-0.53, p = 0.006, whilst patients with eye irritation were more willing to trial the implant (OR 7.20, CI 1.12-142, p = 0.036). CONCLUSION: Certain patient demographics impact patient aesthetic and functional preferences and the willingness to trial the BLINC device.

CDS2 expression regulates de novo phosphatidic acid synthesis.

CDS enzymes (CDS1 and 2 in mammals) convert phosphatidic acid (PA) to CDP-DG, an essential intermediate in the de novo synthesis of PI. Genetic deletion of CDS2 in primary mouse macrophages resulted in only modest changes in the steady-state levels of major phospholipid species, including PI, but substantial increases in several species of PA, CDP-DG, DG and TG. Stable isotope labelling experiments employing both 13C6- and 13C6D7-glucose revealed loss of CDS2 resulted in a minimal reduction in the rate of de novo PI synthesis but a substantial increase in the rate of de novo PA synthesis from G3P, derived from DHAP via glycolysis. This increased synthesis of PA provides a potential explanation for normal basal PI synthesis in the face of reduced CDS capacity (via increased provision of substrate to CDS1) and increased synthesis of DG and TG (via increased provision of substrate to LIPINs). However, under conditions of sustained GPCR-stimulation of PLC, CDS2-deficient macrophages were unable to maintain enhanced rates of PI synthesis via the 'PI cycle', leading to a substantial loss of PI. CDS2-deficient macrophages also exhibited significant defects in calcium homeostasis which were unrelated to the activation of PLC and thus probably an indirect effect of increased basal PA. These experiments reveal that an important homeostatic response in mammalian cells to a reduction in CDS capacity is increased de novo synthesis of PA, likely related to maintaining normal levels of PI, and provides a new interpretation of previous work describing pleiotropic effects of CDS2 deletion on lipid metabolism/signalling.

Determinants of Prognosis in Head and Neck Cutaneous Squamous Cell Carcinoma With Nodal Metastases.

Importance: The eighth edition tumor, node, metastasis (TNM) staging for head and neck cutaneous squamous cell carcinoma (HNcSCC) is a poor predictor of survival in patients with lymph node metastases, possibly due to the inclusion of extranodal extension (ENE). Objective: To identify the key determinants of prognosis in patients with nodal metastatic HNcSCC and analyze the association of ENE with TNM stage and investigate for prognostic heterogeneity in ENE-positive disease. Design, Setting, and Participants: This retrospective, multicenter cohort study was conducted at 4 Australian tertiary referral centers using prospectively collected data in patients treated between 1980 and 2017 with a median (IQR) follow-up of 3.2 (3.9) years. The study population included 1309 consecutive patients with HNcSCC that was metastatic to parotid and/or cervical nodes. After excluding cases with perioperative mortality, missing data, or follow-up, the final study population included 1151 patients. Exposure: Curative intent surgery ± adjuvant radiotherapy. Main Outcomes and Measures: Differences in locoregional control (LRC), disease-specific survival (DSS), and overall survival were determined using Cox regression analysis. Results: Among 1151 patients, 976 (84.8%) were male and 175 (15.2%) female, with a median age of 73.3 years (range, 18-100 years). On multivariable analysis, immunosuppression (hazard ratio [HR], 2.48; 95% CI, 1.64-3.74), perineural invasion (HR, 1.69; 95% CI, 1.25-2.30), ENE (HR, 1.53; 95% CI, 0.95-2.44), size (>3-6 cm vs ≤3 cm [HR, 1.41; 95% CI, 1.03-1.93]; >6 cm vs ≤3 cm [HR, 5.01; 95% CI, 2.98-8.42]), and number of nodal metastases (3-4 vs 1-2 [HR, 1.54; 95% CI, 1.01-2.34]; ≥5 vs 1-2 [HR, 2.86; 95% CI, 1.99-4.11]) were associated with DSS. Similar results were found for LRC and overall survival. More than 90% of the population was categorized as TNM stage IV, with 32% attributable to ENE. In the ENE-positive subset (n = 860), DSS ranged from 8% to 88% based on stratification using other clinicopathological factors. Conclusions and Relevance: The study results suggest that immunosuppression, perineural invasion, ENE, and size and number of nodal metastases are associated with reduced survival and LRC in HNcSCC with nodal metastases. The inclusion of ENE in HNcSCC staging needs to be reassessed, as it ascribes excessive importance to ENE and upstages most patients to TNM stage IV, despite many having a high chance of cure.

Survivorship Needs in Patients With Head and Neck Cancer in Regional, Rural and Remote Areas: A Systematic Review.

OBJECTIVE: Understanding survivorship issues among people with head and neck cancer (HNC) is important as survival rates increase. Most research has focused on urban patients, leaving a gap in understanding the challenges faced by those in rural areas. This study aims to summarise the literature on survivorship needs for people with HNC in rural areas. METHODS: PubMed, PsycINFO, Scopus, Medline, CINAHL, Web of Science, and Embase were searched from database inception to 10 July 2024, with no restriction on publication period, country, or language. Data on study aims, country, methodology, and major findings related to HNC survivors in rural areas were extracted. Study quality was assessed using the Joanna Briggs Institute critical appraisal checklists. RESULTS: Twenty-one studies met the inclusion criteria. Eight studies were qualitative, 11 were quantitative, and two adopted a mixed-methods approach. Results demonstrate the impact of complex treatments on physical (n = 13) and psychosocial (n = 14) functioning. This study also emphasises multifaceted challenges, including reduced access to specialised services, resulting in greater travel and financial burden, extending to caregivers. Hence, primary healthcare services are crucial in supporting these patients closer to home. CONCLUSIONS: Addressing the gaps in equitable post-treatment care requires an even distribution of healthcare funding and workforce in rural areas. Future research could target these issues to develop tailored interventions or models of care, such as shared care, to ease access and financial burden.

A comparison of preoperative soft tissue contour versus bone accuracy as a predictor of quality of life outcomes in osseous free flap jaw reconstruction using occlusal-based virtual surgical planning.

OBJECTIVES: Occlusal-based virtual surgical planning (VSP) prioritises the placement of endosseous dental implants, over replicating native bone contour. This may compromise facial aesthetics. This study aimed to compare function and health-related quality of life (HRQOL) following maxillomandibular reconstruction according to the ability to replicate preoperative soft-tissue contour and virtual plan. MATERIALS AND METHODS: Patients who underwent occlusal based VSP osseous free flap reconstruction of the maxilla or mandible with high-resolution pre- and post-operative facial computerised tomography imaging and completed the FACE-Q questionnaire were retrospectively identified. Accuracy of reconstruction compared to preoperative soft tissue contour and virtual plan, was measured using 3DSlicer® and CloudCompare® in three dimensions. Random effects modelling determined the associations between bony and soft tissue accuracy and HRQOL/functional domains. RESULTS: Twenty-two patients met the inclusion criteria. For mandibular and maxillary reconstructions, better soft tissue accuracy was associated with improved appearance (p = 0.048) and appearance distress (p = 0.034). For mandibular reconstructions, better soft tissue accuracy was associated with improved smile (p = 0.039) and smile distress (p = 0.031). For maxillary reconstructions, better bony accuracy was associated with improved appearance (p = 0.023) and drooling distress (p = 0.001). Unexpectedly, better bony accuracy was associated with worse eating and drinking (p = 0.015), oral competence (p = 0.005) and eating distress (p = 0.013) in mandibular reconstructions. CONCLUSION: Whilst soft tissue accuracy was associated with better functional and HRQOL outcomes, bone accuracy was associated with worse oral function or distress in mandibular reconstruction. These results require validation but should be considered when performing occlusal-based VSP, which prioritises dental rehabilitation over replicating facial bony contour.

Jaw in a day surgery: early experience with 19 patients at an Australian tertiary referral center.

BACKGROUND: The Jaw-in-a-Day (JIAD) procedure aims to achieve immediate functional occlusion via a single-stage approach to maxillofacial reconstruction. While JIAD has gained popularity since its inception by Levine and colleagues, efficacy and outcome data remain limited. In this report, we discuss our experience with the JIAD technique at an Australian tertiary referral centre. METHODS: A retrospective review of all JIAD procedures performed from April 2022 to December 2023 was conducted. Clinicopathologic data reviewed included demographic information, primary diagnosis, anatomical site of disease, and history of pre-operative radiotherapy. Outcome measures of interest included operative time, number of implants placed, post-operative complications and implant survival. RESULTS: Nineteen patients were identified for the study. Two maxillary and 17 mandibular JIAD procedures were performed. The most common indications were squamous cell carcinoma (n = 8) and ameloblastoma (n = 5). Surgical complications included recipient site wound infection (n = 3), flap dehiscence (n = 2), haematoma formation (n = 1), and neck abscess associated with partial flap failure (n = 1). No total flap failures were identified. Of the 55 total implants placed, one implant failure occurred 2-months post-operatively. No loss of irradiated implants (n = 21) was observed. The median time to adjuvant radiotherapy was 57 days (range, 32-61). Eighteen of 19 patients (95%) achieved immediate dental rehabilitation, and 15/19 patients (79%) retained a functional prosthesis by the end of the follow-up period. CONCLUSIONS: Our series supports the feasibility of single-stage reconstruction for both benign and malignant indications. Further research is required to understand the long-term functional, aesthetic, and health-related quality-of-life outcomes with the JIAD technique.

A qualitative exploration of the pathway to diagnosis and treatment of cutaneous squamous cell carcinoma of the head and neck with perineural spread.

BACKGROUND: Perineural spread (PNS) is associated with a poor prognosis in cutaneous squamous cell carcinoma of the head and neck (cSCCHN). Hence, investigating facilitators and barriers of early diagnosis and treatment of PNS in cSCCHN may improve outcomes. METHODS: Patients were recruited from an institutional database. Semi-structured interviews were conducted according to the Model of Pathways to Treatment. Thematic analysis was based on the four main intervals in the framework using a data-driven analytical method. RESULTS: Seventeen participants were interviewed. Facilitators included patients' past experiences, symptom progression, trust in healthcare professionals (HCPs), and capacity to leverage relationships. Barriers included difficult diagnoses, limited access to cancer services, lack of care coordination, and lack of awareness of PNS among primary health care providers. CONCLUSION: These findings emphasise the complexity early diagnosis and treatment of PNS. Interventions like clinical practice guidelines, education for HCPs, and telehealth could facilitate timely detection and management.

Predictors of distant metastatic recurrence in head and neck cutaneous squamous cell carcinoma with lymph node metastases treated with curative intent: A multicenter study.

BACKGROUND: We aimed to identify predictors of distant metastatic recurrence (DMR) in patients with head and neck cutaneous squamous cell carcinoma (HNcSCC) with nodal metastases treated with curative intent. METHODS: Predictors of DMR were identified using Cox regression in a multicenter study of 1151 patients. RESULTS: The 5-year risk of DMR was 9.6%. On multivariate analysis, immunosuppression (HR 2.93; 95% CI: 1.70-5.05; p < 0.001), nodal size >6 cm [versus ≤3 cm (HR 2.77; 95% CI: 1.09-7.03; p = 0.032)], ≥5 nodal metastases [versus 1-2 (HR 2.79; 95% CI: 1.63-4.78; p < 0.001)], and bilateral disease (HR 3.11; 95% CI: 1.40-6.90; p = 0.005) predicted DMR. A DMR risk score was developed that stratified risk from 6.6% (no risk factors) to 100% (≥3 risk factors) (p < 0.001). CONCLUSIONS: The risk of DMR in nodal metastatic HNcSCC increases with immunosuppression, nodal size >6 cm, ≥5 nodal metastases, and bilateral disease. A simple DMR risk score estimated prior to treatment may be clinically useful.

The prevalence and predictors of discharge opioid overprescribing in opioid-naïve patients after breast, gynecologic, and head and neck cancer surgery: a prospective cohort study.

PURPOSE: The management of pain following cancer-related surgeries involves the use of opioid analgesics. Nevertheless, there is little evidence characterizing the utility and prescription patterns of opioids after these procedures. Our primary aim was to identify patients from three types of cancer surgery who were overprescribed with opioids. The secondary aim was to determine the potential predictors of overprescribing in the same period. METHODS: We conducted the study at a single cancer referral hospital. Opioid-naïve patients with breast, gynecologic, or head and neck cancer were studied. Patients were considered opioid-naïve if they had a history of opioid use ≤ 30 mg oral morphine equivalent daily dose for less than seven days in the preceding three months before surgery. We recruited eligible participants by convenience sampling on the wards until at least 102 patients were included in the final analysis. After discharge, we followed up on the participants on day 7 via telephone using a structured proforma including questions to identify the last date and amount of opioid dose taken. The equivalent days of opioid use were calculated by their 24-hr use before discharge and the number of doses prescribed for discharge. Our primary outcome was the prevalence of overprescribing in the three surgical specialties defined as the number of patients taking less than 50% of discharge opioids within the first seven days after discharge. We examined the predictors on incidents of overprescribing using multivariable Poisson regression as the secondary outcome. RESULTS: We recruited 119 patients, and 107 patients were included in the final analysis. There were 59/107 (55%) patients found to be overprescribed with opioids. At discharge, they exhibited lower mean numerical rating scale pain scores, lower mean pain severity scores, higher equivalent days of opioids prescribed, and not used opioids in the last 24 hr before discharge. The incidence of overprescribing was 2.4 times greater for patients prescribed with opioids without 24-hr opioid use (relative risk [RR], 2.38; 95% confidence interval [CI], 1.30 to 4.35; P = 0.005). Similarly, the incidence of overprescribing was 1.7 times greater for patients who had opioids 24 hr before discharge and were supplied with opioids for five equivalent days or more at the time of discharge (RR, 1.67; 95% CI, 1.09 to 2.56; P = 0.02). CONCLUSION: Our study shows that the majority of recruited patients undergoing breast, gynecologic, or head and neck cancer surgery were overprescribed opioids. Individualized assessments on patients' 24-hr opioid requirements before discharge and supplying for less than five days are important considerations to reduce overprescribing in opioid-naïve patients after cancer surgery.

RéSUMé: OBJECTIF: La prise en charge de la douleur à la suite d'interventions chirurgicales liées au cancer passe par l'utilisation d'analgésiques opioïdes. Néanmoins, il existe peu de données probantes caractérisant l'utilité et les habitudes de prescription des opioïdes après ces interventions. Notre objectif principal était d'identifier les patient·es de trois types de chirurgie du cancer auxquel·les des opioïdes avaient été surprescrits. L'objectif secondaire était de déterminer les prédicteurs potentiels de surprescription au cours de la même période. MéTHODE: Nous avons mené cette étude dans un seul hôpital de référence pour le cancer. La patientèle naïve aux opioïdes atteinte de cancer du sein, gynécologique ou de la tête et du cou a été étudiée. Les patient·es étaient considéré·es comme naïfs ou naïves aux opioïdes si leurs antécédents d'utilisation d'opioïdes étaient inférieurs ou égaux à une dose quotidienne équivalente à 30 mg de morphine orale pendant moins de sept jours au cours des trois mois précédant la chirurgie. Nous avons recruté les participant·es éligibles par échantillonnage de commodité dans les services jusqu'à ce qu'au moins 102 personnes soient incluses dans l'analyse finale. Après le congé, nous avons fait un suivi téléphonique auprès des participant·es le 7e jour à l'aide d'un formulaire structuré comprenant des questions visant à identifier la dernière date et la dose d'opioïdes prise. Les jours équivalents de consommation d'opioïdes ont été calculés en fonction de leur utilisation dans les 24 heures précédant le congé et du nombre de doses prescrites pour le congé. Notre critère d'évaluation principal était la prévalence de la surprescription dans les trois spécialités chirurgicales, définie comme le nombre de patient·es prenant moins de 50 % des opioïdes reçus au congé dans les sept premiers jours suivant le congé. Nous avons examiné les prédicteurs d'incidents de surprescription en utilisant la régression de Poisson multivariée comme critère d'évaluation secondaire. RéSULTATS: Nous avons recruté 119 patient·es, et 107 patient·es ont été inclus·es dans l'analyse finale. Une surprescription d'opioïdes a été observée pour 59 patient·es sur 107 (55 %). À leur congé, ces personnes présentaient des scores de douleur moyens plus faibles sur l'échelle d'évaluation numérique, des scores moyens de gravité de la douleur plus faibles, des jours équivalents d'opioïdes prescrits plus élevés et n'avaient pas utilisé d'opioïdes dans les 24 heures précédant le congé. L'incidence de surprescription était 2,4 fois plus élevée chez les patient·es à qui l'on avait prescrit des opioïdes sans utilisation d'opioïdes dans les 24 heures (risque relatif [RR], 2,38; intervalle de confiance [IC] à 95 %, 1,30 à 4,35; P = 0,005). De même, l'incidence de surprescription était 1,7 fois plus élevée chez les patient·es qui avaient reçu des opioïdes 24 heures avant le congé et qui avaient reçu des opioïdes pendant cinq jours équivalents ou plus au moment du congé (RR, 1,67; IC 95 %, 1,09 à 2,56; P = 0,02). CONCLUSION: Notre étude montre qu'il y a eu surprescription d'opioïdes pour la majorité des patient·es recruté·es bénéficiant d'une chirurgie de cancer du sein, gynécologique ou de la tête et du cou. Des évaluations individualisées des besoins en opioïdes des patient·es dans les 24 heures avant leur congé et une administration pendant moins de cinq jours sont des considérations importantes pour réduire la surprescription chez les personnes naïves aux opioïdes après une chirurgie oncologique.

This year sees an opportunity for long-needed oral health reforms. Cancer patients, in particular, stand to benefit.

The long-standing divide in Australia between medicine and dentistry has left many with inequitable access to dental care. People with oral cancer, in particular, may have few options for dental rehabilitation after cancer treatment, even with private health insurance. However, 2024 could finally see health care reforms that address these inequities, with significant momentum building in Australia. In this Perspective, we argue for a national approach to reforms that incorporate aspects of preventive health, primary health care, Medicare Benefits Schedule item review, and the value of Private Health Insurance rebates for dental care.

Models of survivorship care in patients with head and neck cancer in regional, rural, and remote areas: a systematic review.

PURPOSE: Rural people with head and neck cancers (HNC) are likely to experience poorer health outcomes due to limited access to health services, so many benefit from models of care that account for rurality. The aim of this review was to synthesise literature on models of care in this population. METHODS: Studies were identified using seven databases: PubMed, PsycINFO, Scopus, Embase, CINAHL, Medline, and Web of Science. Studies that tested or reported a model of care in rural HNC survivors were included. Data on characteristics and outcomes of the models were synthesised according to the domains in the Cancer Survivorship Care Quality Framework, and study quality was appraised. RESULTS: Seventeen articles were included. Eight were randomised controlled trials (seven with a control group and one single-arm study). Three models were delivered online, nine via telehealth, and five in-person. Majority were led by nurses and allied health specialists and most addressed management of physical (n = 9) and psychosocial effects (n = 6), while only a few assessed implementation outcomes such as cost-effectiveness. None evaluated the management of chronic health conditions. CONCLUSION: Positive outcomes were reported for domains of survivorship care that were measured; however, further evaluation of models of care for rural people with HNC is needed to assess effectiveness across all domains of care. IMPLICATIONS FOR CANCER SURVIVORS: Rural cancer survivors are a diverse population with unique needs. Alternative models of care such as shared care, or models personalised to the individual, could be considered to reduce disparities in access to care and outcomes.

What is the force required to treat trismus in patients undergoing oral cavity free flap reconstruction?

BACKGROUND: Trismus therapy is often delayed after jaw reconstruction to avoid hardware failure or non-union. The aim of this study is to document the forces that have been applied to patients undergoing free flap reconstruction of the oral cavity in the 12 months following oral cavity reconstruction, and to analyze the associations between force and maximal interincisal opening (MIO) over time. METHODS: Participants with trismus after free flap reconstruction of the oral cavity completed a 10-week jaw stretching program using Restorabite™. Primary outcome measures included the minimum and maximal force applied by a trismus device during rehabilitation, MIO, bone union, and health-related quality of life outcomes up to 12 months postoperatively. RESULTS: A mean of 20.6 Newtons (N) was used during passive exercises and 38.9 N during active exercises was used during trismus therapy. The mean increase in MIO for the 45 participants after 10 weeks, 6 months, and 12 months of therapy was 8.4 mm (p < 0.001), 12.6 mm (p < 0.001), 12.7 mm (p < 0.001), respectively. There was no significant difference in the mean minimal (p = 0.37) or mean maximal (p = 0.08) force applied between those who underwent osseous free flap reconstruction compared to fasciocutaneous only, respectively. In patients who underwent osseous reconstruction, 25 (67.6%) had complete bone union and 12 (32.4%) had partial union at 12 months postsurgery. CONCLUSIONS: In participants undergoing osseous free flap reconstruction, there was no association between the force applied to the rates of bone union. Further research to define safe and optimal loading may benefit patients undergoing jaw reconstruction.

Systematic review of adherence to swallow and trismus exercises during radiation therapy for head and neck cancer.

Understanding the barriers and facilitators for prophylactic swallowing and trismus exercises for patients undergoing radiation to the head and neck may help exercise adherence. The analysis reviews all published reports of exercise adherence with a critical appraisal following PRISMA guidelines. A total of 137 potential papers were identified; 20 studies met the inclusion criteria. The most commonly reported facilitators for swallowing and trismus exercises were regular clinician contact and online resources to reinforce instructions, set goals, and manage radiation toxicities. Social support and perceived benefit from exercises were also reported to be of help. The most common barriers to exercise were radiation toxicities, anxiety, feeling overwhelmed with information, and not understanding the reason for the exercises. Understanding facilitators and barriers to adherence is critical when designing exercise interventions for patients undergoing radiation for head and neck cancer.

Association between Swallowing Outcomes and Dose to Critical Swallow Structures in Patients Undergoing Transoral Robotic Surgery and Post-Operative Radiation Therapy.

BACKGROUND: The radiation dose to dysphagia and aspiration-related structures (DARS) for patients undergoing transoral robotic surgery (TORS) and post-operative radiation therapy (PORT) for primary oropharyngeal carcinoma is unknown. METHODS: This prospective study measured swallowing using the MD Anderson Dysphagia Inventory at baseline and then 12-months after PORT. Dosimetric parameters were collected. RESULTS: 19 patients were recruited between 2017 and 2019. Worse swallow function at 12-months after PORT was associated with dose-parameters to the oesophageal inlet muscle, superior pharyngeal constrictor muscle and cervical oesophagus. Mean dose, V50Gy, and V60Gy to the base of tongue and pharyngeal constrictors was significantly lower in those receiving PORT to the neck alone. CONCLUSION: Dose to DARS was lower in patients who received PORT to the neck alone. In patients treated with TORS and PORT, poorer swallowing outcomes at 12 months post-treatment were associated with increased dose to oesophageal inlet muscle, superior constrictor muscle, and cervical oesophagus.

A Preclinical Trial Protocol Using an Ovine Model to Assess Scaffold Implant Biomaterials for Repair of Critical-Sized Mandibular Defects.

The present work describes a preclinical trial (in silico, in vivo and in vitro) protocol to assess the biomechanical performance and osteogenic capability of 3D-printed polymeric scaffolds implants used to repair partial defects in a sheep mandible. The protocol spans multiple steps of the medical device development pipeline, including initial concept design of the scaffold implant, digital twin in silico finite element modeling, manufacturing of the device prototype, in vivo device implantation, and in vitro laboratory mechanical testing. First, a patient-specific one-body scaffold implant used for reconstructing a critical-sized defect along the lower border of the sheep mandible ramus was designed using on computed-tomographic (CT) imagery and computer-aided design software. Next, the biomechanical performance of the implant was predicted numerically by simulating physiological load conditions in a digital twin in silico finite element model of the sheep mandible. This allowed for possible redesigning of the implant prior to commencing in vivo experimentation. Then, two types of polymeric biomaterials were used to manufacture the mandibular scaffold implants: poly ether ether ketone (PEEK) and poly ether ketone (PEK) printed with fused deposition modeling (FDM) and selective laser sintering (SLS), respectively. Then, after being implanted for 13 weeks in vivo, the implant and surrounding bone tissue was harvested and microCT scanned to visualize and quantify neo-tissue formation in the porous space of the scaffold. Finally, the implant and local bone tissue was assessed by in vitro laboratory mechanical testing to quantify the osteointegration. The protocol consists of six component procedures: (i) scaffold design and finite element analysis to predict its biomechanical response, (ii) scaffold fabrication with FDM and SLS 3D printing, (iii) surface treatment of the scaffold with plasma immersion ion implantation (PIII) techniques, (iv) ovine mandibular implantation, (v) postoperative sheep recovery, euthanasia, and harvesting of the scaffold and surrounding host bone, microCT scanning, and (vi) in vitro laboratory mechanical tests of the harvested scaffolds. The results of microCT imagery and 3-point mechanical bend testing demonstrate that PIII-SLS-PEK is a promising biomaterial for the manufacturing of scaffold implants to enhance the bone-scaffold contact and bone ingrowth in porous scaffold implants. MicroCT images of the harvested implant and surrounding bone tissue showed encouraging new bone growth at the scaffold-bone interface and inside the porous network of the lattice structure of the SLS-PEK scaffolds.

Exercise adherence for patients with trismus after head and neck cancer treatment.

BACKGROUND: Head and neck cancer treatment often leads to trismus, a condition characterized by limited mouth opening. Exercise-based therapy is the most common intervention but there are no clear guidelines as to the optimal exercise regimen. Restorabite™ is a portable and force-regulated trismus device designed to enhance exercise adherence. This study explores the adherence to exercises using Restorabite™ in head and neck cancer patients with trismus and identifies facilitators and barriers to exercise therapy. MATERIALS AND METHODS: Mixed-methods, prospective cohort study undertaken at a quaternary oncology hospital, in Sydney Australia involving participants diagnosed with head and neck cancer diagnosed with trismus (maximal incisal opening under 35 mm). Patients underwent a 10-week individualized trismus program using Restorabite™ with weekly speech pathology reviews. Exercise adherence was tracked through categorized descriptors. Data were collected prospectively at baseline, during 10 weeks of therapy with Restorabite™, and at 6- and 12-month post-trismus exercise. Participants described facilitators of trismus therapy, and barriers to completing the prescribed exercises. Clinical documentation of these responses was then analyzed using content analysis. RESULTS: One-hundred and thirty-five participants were recruited. During the intervention 69% (n = 93) exercised as recommended, 24% (n = 32) exercised less, and 7% (n = 10) exercised more than recommended. At 6 months post-intervention, 55.5% (n = 75) exercised as recommended, 38.5% (n = 52) exercised less, and 4% (n = 6) exercised more. At 12 months, 36% (n = 49) exercised as recommended, 48% (n = 62) exercised less, and 11% (n = 15) exercised more. MIO increased from a mean of 18.6 mm at baseline, to 30.1 mm at the end of the 10-week intervention. This was maintained at 6 and 12 months (31.7 and 32.1 mm, respectively). Adherence to the exercise program was associated with greater improvement in maximum interincisal opening (p < 0.001). Facilitators of adherence included intrinsic motivation, device portability, perceived functional change, and external support tools. Barriers included cancer treatment toxicities, competing priorities, and health challenges. Positive outcomes included functional improvements, while negative outcomes included increased pain. CONCLUSIONS: Seventy-six percent of patients prescribed Restorabite™ performed trismus exercises at or more than the recommended frequency. Facilitators and barriers identified provide insights into factors influencing adherence. Future research should involve comparative studies that compare the adherence and effectiveness of different exercise programs.

Restorabite™: Phase II trial of jaw stretching exercises using a novel device for patients with trismus following head and neck cancer.

Patients treated for oral cancer, may experience restricted mouth opening (trismus). Barriers such as cost have limited the utilization of traditional jaw stretching devices, and consequently, patients experience problems with swallowing, oral care, communication, and cancer surveillance. The safety and efficacy of Restorabite™, a new device designed to overcome these barriers, is evaluated prospectively over 12 months. This phase II investigator-led trial included patients with chronic trismus underwent 10-weeks of trismus therapy using Restorabite™. Safety, adherence, changes in mouth opening, and patient-reported outcomes are presented. 114/120 participants with trismus completed the intervention, and 104 had their progress monitored for 12 months. Thirteen participants withdrew due to tumour recurrence. At the completion of the intervention, mouth opening improved by 10.4 mm (p < .001). This increased to 13.7 mm at 12 months (p < .001). Patient reported outcome all significantly improved and 47 participants were no longer classified as having trismus. There were no serious treatment related adverse events. In patients with trismus following head and neck cancer treatment, a 10-week programme of jaw stretching exercises using Restorbite™ safely improves mouth opening and associated quality of life outcomes with high adherence and the benefits are maintained for 12-months.