Economic evaluation of the Very Early Rehabilitation in SpEech (VERSE) intervention.

INTRODUCTION: There is limited evidence on the costs and outcomes of patients with aphasia after stroke. The aim of this study was to estimate costs in patients with aphasia after stroke according to the aphasia therapies provided. METHODS: A three-arm, prospective, randomized, parallel group, open-label, blinded endpoint assessment trial conducted in Australia and New Zealand. Usual ward-based care (Usual Care) was compared to additional usual ward-based therapy (Usual Care Plus) and a prescribed and structured aphasia therapy program in addition to Usual Care (the VERSE intervention). Information about healthcare utilization and productivity were collected to estimate costs in Australian dollars for 2017-18. Multivariable regression models with bootstrapping were used to estimate differences in costs and outcomes (clinically meaningful change in aphasia severity measured by the WAB-R-AQ). RESULTS: Overall, 202/246 (82%) participants completed follow-up at 26 weeks. Median costs per person were $23,322 (Q1 5,367, Q3 52,669, n = 63) for Usual Care, $26,923 (Q1 7,303, Q3 76,174, n = 70) for Usual Care Plus and $31,143 (Q1 7,001. Q3 62,390, n = 69) for VERSE. No differences in costs and outcomes were detected between groups. Usual Care Plus was inferior (i.e. more costly and less effective) in 64% of iterations, and in 18% was less costly and less effective compared to Usual Care. VERSE was inferior in 65% of samples and less costly and less effective in 12% compared to Usual Care. CONCLUSION: There was limited evidence that additional intensively delivered aphasia therapy within the context of usual acute care provided was worthwhile in terms of costs for the outcomes gained.

Search for Evidence of Baryogenesis and Dark Matter in B

A new dark sector antibaryon, denoted ψ_{D}, could be produced in decays of B mesons. This Letter presents a search for B^{+}→ψ_{D}+p (and the charge conjugate) decays in e^{+}e^{-} annihilations at 10.58 GeV, using data collected in the BABAR experiment. Data corresponding to an integrated luminosity of 398 fb^{-1} are analyzed. No evidence for a signal is observed. Branching fraction upper limits in the range from 10^{-7}-10^{-5} are obtained at 90% confidence level for masses of 1.0

Evaluating remote facilitation intensity for multi-national translation of nurse-initiated stroke protocols (QASC Australasia): a protocol for a cluster randomised controlled trial.

BACKGROUND: Facilitated implementation of nurse-initiated protocols to manage fever, hyperglycaemia (sugar) and swallowing difficulties (FeSS Protocols) in 19 Australian stroke units resulted in reduced death and dependency for stroke patients. However, a significant gap remains in translating this evidence-based care bundle protocol into standard practice in Australia and New Zealand. Facilitation is a key component for increasing implementation. However, its contribution to evidence translation initiatives requires further investigation. We aim to evaluate two levels of intensity of external remote facilitation as part of a multifaceted intervention to improve FeSS Protocol uptake and quality of care for patients with stroke in Australian and New Zealand acute care hospitals. METHODS: A three-arm cluster randomised controlled trial with a process evaluation and economic evaluation. Australian and New Zealand hospitals with a stroke unit or service will be recruited and randomised in blocks of five to one of the three study arms-high- or low-intensity external remote facilitation or a no facilitation control group-in a 2:2:1 ratio. The multicomponent implementation strategy will incorporate implementation science frameworks (Theoretical Domains Framework, Capability, Opportunity, Motivation - Behaviour Model and the Consolidated Framework for Implementation Research) and include an online education package, audit and feedback reports, local clinical champions, barrier and enabler assessments, action plans, reminders and external remote facilitation. The primary outcome is implementation effectiveness using a composite measure comprising six monitoring and treatment elements of the FeSS Protocols. Secondary outcome measures are as follows: composite outcome of adherence to each of the combined monitoring and treatment elements for (i) fever (n=5); (ii) hyperglycaemia (n=6); and (iii) swallowing protocols (n=7); adherence to the individual elements that make up each of these protocols; comparison for composite outcomes between (i) metropolitan and rural/remote hospitals; and (ii) stroke units and stroke services. A process evaluation will examine contextual factors influencing intervention uptake. An economic evaluation will describe cost differences relative to each intervention and study outcomes. DISCUSSION: We will generate new evidence on the most effective facilitation intensity to support implementation of nurse-initiated stroke protocols nationwide, reducing geographical barriers for those in rural and remote areas. TRIAL REGISTRATION: ACTRN12622000028707. Registered 14 January, 2022.

Delivery outcomes as a result of snoring as determined by standard sleep surveys.

Background: Sleep-disordered breathing (SDB), is an umbrella term that encompasses obstructive sleep apnea (OSA), central sleep apnea (CSA) and hypoventilation. is common but studies in the pregnant population are limited. Data suggests relationships between OSA and preeclampsia, but the relationship between snoring and pregnancy outcomes is unknown. Methods: A prospective study of 2224 singleton pregnancies was undertaken. Women were questioned using the Berlin Questionnaire (BQ- 2 or more categories where the score is positive.) and the Epworth Sleepiness Scale (ESS >10/24), the results compared with pregnancy outcomes with regard to hypertension in pregnancy. Results: Women having symptoms raising the possibility of OSA defined by the BQ with a score >7 was 45.5%, and using ESS with a score >10, was 36%. The birth and neonatal outcomes for self-reported snoring and increased daytime sleepiness showed increased adverse outcomes notably increased caesarean section rates and low APGAR scores but not birth before 37 weeks of gestation. Conclusion: Using questionnaires designed for the general population, the prevalence of possible undiagnosed OSA is high in the pregnant population. The increased adverse delivery and neonatal outcomes for self-reported snoring and increased daytime sleepiness with these tools indicated the need for further investigation of the links between snoring SDB and pregnancy outcomes.

Search for an Axionlike Particle in B Meson Decays.

Axionlike particles (ALPs) are predicted in many extensions of the standard model, and their masses can naturally be well below the electroweak scale. In the presence of couplings to electroweak bosons, these particles could be emitted in flavor-changing B meson decays. We report herein a search for an ALP, a, in the reaction B^{±}→K^{±}a, a→γγ using data collected by the BABAR experiment at SLAC. No significant signal is observed, and 90% confidence level upper limits on the ALP coupling to electroweak bosons are derived as a function of ALP mass, improving current constraints by several orders of magnitude in the range 0.175 GeV

Search for Lepton Flavor Violation in ϒ(3S)→e

We report on the first search for electron-muon lepton flavor violation (LFV) in the decay of a b quark and b antiquark bound state. We look for the LFV decay ϒ(3S)→e^{±}µ^{∓} in a sample of 118 million ϒ(3S) mesons from 27 fb^{-1} of data collected with the BABAR detector at the SLAC PEP-II e^{+}e^{-} collider operating with a 10.36 GeV center-of-mass energy. No evidence for a signal is found, and we set a limit on the branching fraction B[ϒ(3S)→e^{±}µ^{∓}]<3.6×10^{-7} at 90% C. L. This result can be interpreted as a limit Λ_{NP}/g_{NP}^{2}>80 TeV on the energy scale Λ_{NP} divided by the coupling-squared g_{NP}^{2} of relevant new physics (NP).

Barriers and enablers to implementinghospital-acquired urinary tract infection prevention strategies: a qualitative study using the Theoretical Domains Framework.

BACKGROUND: Consistent implementation of evidence-based hospital-acquired urinary tract infection (UTI) prevention strategies remains a challenge in acute and subacute care settings. Addressing the evidence-practice gap requires an understanding of factors affecting implementation of hospital-acquired UTI prevention strategies in this high-risk setting. AIM: To identify the perceived barriers and enablers of clinicians to implementing hospital-acquired UTI prevention strategies in an Australian subacute hospital. METHODS: Qualitative semi-structured virtual interviews, underpinned by the Theoretical Domains Framework (TDF), were conducted with purposively selected nurses (N = 8) and doctors (N = 2) at one subacute metropolitan hospital. Interview data were content-analysed using the TDF as the coding framework. FINDINGS: Eight TDF domains were identified as important in understanding barriers and enablers to implementing hospital-acquired UTI prevention strategies: Knowledge, Skills, Beliefs about capabilities, Emotion, Professional role and identity, Environmental context and resources, Goals, and Behavioural regulation. Barriers were poor awareness of clinical practice guidelines for hospital-acquired UTI prevention; lack of training; staff shortages; competing workloads; lack of procedural equipment for urinary catheterization; difficulty with implementing prevention strategies in cognitively impaired patients; language barriers; and lack of feedback and use of incident reporting data to influence clinical practice. Presence of a proactive staff culture and positive team approach to work emerged as enablers. Audit and feedback, clinical champions, education, and patient information resources in languages other than English were identified as potential enablers. CONCLUSION: The findings will inform development of theoretically informed behaviour change interventions to promote successful implementation of hospital-acquired UTI prevention strategies in the subacute setting.

Self-care research: How to grow the evidence base? (reprint).

BACKGROUND AND OBJECTIVE: The number of studies in the area of self-care is growing and international researchers are increasingly developing self-care interventions to improve outcomes of individual patients and communities. However, growth of the evidence is still slow due to challenges with designing and testing self-care interventions. In this article we address major methodological challenges with regard to the definition of self-care, use of theory, and research design, intended to provide guidance to researchers in this field. METHOD: During the inaugural conference of the International Center for Self-Care Research held in Rome, Italy in June 2019 we identified important issues in existing self-care research. Discussion and literature review lead to eight recommendation for future self-care research. RESULTS: In preparation, begin with a theoretically sound definition of self-care. In planning the intervention, build on and extend previous studies. Use theory to develop self-care interventions and consider translational models to guide development, evaluation and implementation of complex self-care interventions. Employ a study design that fits the current phase and objectives of the research and measure self-care and related factors carefully. In reporting, describe the sample and setting sufficiently so that others can draw conclusions about generalizability and applicability to their practice and patient population. In interpretation, describe how the intervention is assumed to work (causal assumptions) and its key components. CONCLUSION: Our review of existing self-care research clearly illustrates that the recommendations we provide are needed if we are to substantially grow the evidence base supporting self-care. Embracing a core set of principles will allow us to build on each other's work. Tweetable abstract: A core set of methodological principles is needed to substantially grow the evidence base supporting self-care.

Paraplegia Secondary to Plasmacytoma of the Lumbar Spine.

BACKGROUND: Solitary plasmacytoma of bone has a predilection for the axial skeleton, most commonly affecting the thoracic spine. We report the case of a patient who presented with acute on chronic back pain and developed severe neurologic deficits within several hours of admission secondary to a pathologic fracture of L1. METHODS: The patient underwent an urgent magnetic resonance imaging scan followed by T12 to L2 posterior decompression and T11 to L3 posterior instrumented stabilization. Subsequent histopathologic examination of specimens taken at the time of surgery found this to be secondary to a plasmacytoma affecting the lumbar spine. RESULTS: At follow-up, recovery has been rapid and extensive, with the patient remaining under hematologic review because of the risk for developing multiple myeloma. CONCLUSIONS: The unique features of this case relate to the location of the plasmacytoma and the neurologic signs; to our knowledge this is the first reported case in the literature of paraplegia secondary to a lumbar spine plasmacytoma.

International translation of Fever, Sugar, Swallow Protocols: The Quality in Acute Stroke Care Europe Project.

The Quality in Acute Stroke (QASC) trial demonstrated a significant reduction in death and disability when clinicians were assisted to introduce protocols to manage fever, hyperglycaemia (sugar) and swallowing (FeSS) following stroke. We describe a unique international collaboration between the Nursing Research Institute at Australian Catholic University; the European Stroke Organisation; and the Angels Initiative, working collaboratively to support implementation of the nurse-led FeSS Protocols in 20 European countries. We currently have 71 hospitals from 16 countries participating (hospitals from four countries are in the preparation phase) with 49 hospitals currently entering data (n=2819 patients to-date). Baseline data have been received from 39 hospitals, with FeSS Protocol implementation commenced at 16 hospitals. Five hospitals have completed the Project. 'Upscale and spread' of these evidence-based, nursing protocols into countries with vastly different healthcare systems, many of whom also have no access to the latest stroke therapies, is likely to make a significant impact in reducing death and disability after stroke.

Self-care research: How to grow the evidence base?

BACKGROUND AND OBJECTIVE: The number of studies in the area of self-care is growing and international researchers are increasingly developing self-care interventions to improve outcomes of individual patients and communities. However, growth of the evidence is still slow due to challenges with designing and testing self-care interventions. In this article we address major methodological challenges with regard to the definition of self-care, use of theory, and research design, intended to provide guidance to researchers in this field. METHOD: During the inaugural conference of the International Center for Self-Care Research held in Rome, Italy in June 2019 we identified important issues in existing self-care research. Discussion and literature review lead to eight recommendation for future self-care research. RESULTS: In preparation, begin with a theoretically sound definition of self-care. In planning the intervention, build on and extend previous studies. Use theory to develop self-care interventions and consider translational models to guide development, evaluation and implementation of complex self-care interventions. Employ a study design that fits the current phase and objectives of the research and measure self-care and related factors carefully. In reporting, describe the sample and setting sufficiently so that others can draw conclusions about generalizability and applicability to their practice and patient population. In interpretation, describe how the intervention is assumed to work (causal assumptions) and its key components. CONCLUSION: Our review of existing self-care research clearly illustrates that the recommendations we provide are needed if we are to substantially grow the evidence base supporting self-care. Embracing a core set of principles will allow us to build on each other's work. Tweetable abstract: A core set of methodological principles is needed to substantially grow the evidence base supporting self-care.

Increased fluid intake for the prevention of urinary tract infection in adults and children in all settings: a systematic review.

BACKGROUND: Non-antibiotic interventions for urinary tract infection (UTI) prevention have been investigated as a strategy to reduce antibiotic prescribing for UTI and subsequent antibiotic resistance. Increased hydration is widely advocated for preventing UTI; however, evidence for its effectiveness is unknown. AIM: To systematically review the published literature on the effectiveness of increased fluid intake as a preventive intervention for UTI in adults and children in any setting. METHODS: Five electronic databases were searched from inception to February 2019 to identify published randomized controlled trials (RCTs) and quasi-experimental studies evaluating the effectiveness of high (≥1.5 L/24 h) versus normal/low (<1.5 L/24 h) fluid intake for UTI prevention. The outcome was UTI incidence. Risk of bias was assessed using the Cochrane Collaboration's tool. Due to the small number of studies identified, meta-analysis was not possible. Hence a narrative synthesis was undertaken. FINDINGS: Of the 2822 potentially relevant papers, two were eligible for inclusion: an RCT (individual randomization) and a cluster-RCT. Both studies differed regarding participants, setting, sample size, UTI definition, and intervention. The RCT was assessed as having a low risk of bias whereas the cluster-RCT had a high risk of bias. Only the RCT, which included healthy premenopausal women visiting primary care clinics, demonstrated statistical significance for the effect of high fluid intake for UTI prevention. CONCLUSION: The lack of enough adequately powered and robust RCTs highlights the need for further research on the effectiveness of this intervention for UTI prevention.

Meniscal allograft transplantation in the paediatric population: early referral is justified.

PURPOSE: The need for meniscal allograft transplantation (MAT) in children is rare, and as a result, there is a paucity of evidence detailing survivorship and clinical outcome. MAT has been shown to significantly reduce pain and improve function in the adult population. The aim of this study was to document the outcomes of a single surgeon case series of MAT in the paediatric population. METHODS: Analysis of a prospective meniscal allograft transplantation (MAT) group database of 280 patients was performed. Twenty-three patients met the inclusion criteria-undergoing MAT aged 18 years or younger. RESULTS: Fourteen were female and nine were male with median age of 17 (range 8-18). Thirteen (57%) were right knee and nineteen (83%) were lateral. Additional procedures included high tibial osteotomy, anterior cruciate ligament reconstruction, and microfracture procedures. The median follow-up was 3.8 years (range of 0.2 to 7.8 years). There have been no cases of graft failure. All patients demonstrated improvement in all the modalities of the KOOS outcome scores. At 5 years, the Lysholm score had improved from 57.9 to 87.6 (SD 12.1), Tegner activity score had improved from 2 to 5 (range 4-7) and IKDC score had improved from 40.6 to 78.6 (SD 15.8). Four patients required secondary surgical intervention. No patients developed a superficial or deep infection. CONCLUSION: Meniscal allograft transplantation in children is founded on the successful results of MAT in the adult population. We have demonstrated in this series that MAT can improve function and reduce pain in the paediatric population, and is, therefore, a viable treatment option for the management of the symptomatic paediatric meniscal-deficient knee. Early referral should be considered in the patients with post-meniscectomy syndrome, pain on weight bearing with a history of previous menisectomy. LEVEL OF EVIDENCE: IV.

The largest survivorship and clinical outcomes study of the fixed bearing Stryker Triathlon Partial Knee Replacement - A multi-surgeon, single centre cohort study with a minimum of two years of follow-up.

BACKGROUND: The surgical management of isolated medial compartment degenerative disease of the knee causes debate. Unicompartmental arthroplasty options include fixed and mobile bearing implant designs with fixed bearing becoming increasingly popular. We present the largest cohort of a fixed bearing single radius design, Stryker Triathlon Partial Knee Replacement (PKR). METHODS: We prospectively collected demographic data and patient reported outcome measures (PROMs) on our cohort of PKR implants since its adoption in our unit, 2009 until March 2015. RESULTS: A total of 129 implants in 115 patients with a mean follow-up of 5.5 years (2.5 to 8.5 years) were included. There were 11 revisions at an average of 1.7 years (0.6-4.1 years), two for infection, two for mal-alignment, five for progression of disease and two for loosening. The survivorship of the implants at five years is 90%. CONCLUSION: The PKR provides good survivorship at five years and PROM scores that are equal to the largest and most popular comparable implants. There is an associated learning curve with this implant, as there is with all systems and this is reflected in our results.

Mid-term survivorship and clinical outcomes of the Avon patellofemoral joint replacement.

BACKGROUND: We present the largest series of Avon patellofemoral joint (PFJ) replacements outside of the design centre. There is discussion over its efficacy and usefulness. We report an independent opinion of its indications, survivorship and outcomes. METHODS: We prospectively collected demographic data and patient reported outcome measures (PROM's) on our cohort of Avon Patellofemoral replacements since its adoption in our unit in 2003 until 2014. We performed a retrospective review of radiographs. RESULTS: We performed 103 PFJ replacements in 85 patients, 36 were male (mean age 61 - range 34 to 78) and 67 female (mean age 60 - range 38 to 82), mean follow up time was 5.6years (range 2.9 to 14.2years) with 93 implants still in situ. Their mean post-operative Oxford Knee Score was 36 (range seven to 48). There were nine conversions to TKR for disease progression and one revision of a femoral component for trochlear malpositioning. Mean time to revision was 2.9years (1.0 to 6.0years). Radiographic evidence of progression on Kellgren and Lawrence score in the un-replaced compartments was demonstrated in 23% of cases with imaging available. The Avon PFJ replacement delivers reproducible and effective pain relief and function to patients with isolated patellofemoral osteoarthritis. We believe PFJ replacement has an important role to play, and we will continue to perform this procedure for a carefully selected group of patients. Conversion to TKR does not and should not be regarded as failure of the index operation.

Decortication and osteotomy for the correction of multiplanar deformity in the treatment of malunion in adult diaphyseal femoral deformity: a case series and technique description.

AIM: To review patients that have undergone correction of a symptomatic femoral malunion using osteotomy combined with decortication. METHODS: A retrospective review of all patients who have undergone decortication and multiplanar osteotomy, looking at the pre-operative deformity, correction achieved, time to union and complications. RESULTS: Seven patients underwent correction under the senior author from 2003 to 2012. Average age was 46 years (range 32-60 years). All had femoral shortening deformity (average 2.7 cm, range 2-4 cm). Each also had at least one other plane of deformity with rotation being the next most commonly encountered in 5 out of the 7 (average 33°, range 0°-45°). Two had tri-planar deformity with the five having bi-planar deformity. Average time to union was 16.3 months (range 7-39 months) with an average of 1.5 operations (range 1-3 operations) to union. One patient has a non-union after five corrective operations. CONCLUSION: Correction of multiplanar deformity of the femur is challenging. Osteotomy with decortication provides a technique to achieve significant femoral multiplanar deformity correction in a single operation. This publication provides technical description of the operative technique, guidance and results.

Vocal palsy increases the risk of lower respiratory tract infection in low-risk, low-morbidity patients undergoing thyroidectomy for benign disease: A big data analysis.

OBJECTIVES: Thyroidectomy is the commonest operation that places normally functioning laryngeal nerves at risk of injury. Vocal palsy is a major risk factor for dysphonia, dysphagia, and less commonly, airway obstruction. We investigated the association between post-thyroidectomy vocal palsy and long-term risks of pneumonia and laryngeal failure. DESIGN: An N=near-all analysis of the English administrative dataset using a previously validated informatics algorithm to identify young and otherwise low-risk patients undergoing first-time elective thyroidectomy for benign disease. Information about age, sex, morbidities, social deprivation and post-operative and late complications were derived. MAIN OUTCOME MEASURES: Between 2004 and 2012, 43 515 patients between the ages of 20 and 69 who had no history of cancer, neurological, or respiratory disease underwent elective total or hemithyroidectomy without concomitant or late neck dissection, parathyroidectomy or laryngotracheal surgery for benign thyroid disease for the first and only time. Information about age, sex, morbidities and in-hospital and late complications was recorded. RESULTS: Mean age at surgery was 46±12. There was a strong female preponderance (85%), and most patients (89%) had no recorded Charlson comorbidities Most patients (65%) underwent hemithyroidectomy. Late vocal palsy was recorded in 449 (1.03%) patients, and its occurrence was an independent risk factor for emergency hospital readmission (n=7113; Hazard Ratio 1.52; 95% confidence interval 1.21-1.91), hospitalisation for lower respiratory tract infection (n=944; HR 2.04; 95% CI 1.07-3.75), dysphagia (n=564; HR 3.47; 95% CI 1.57-7.65) and gastrostomy/tracheostomy placement (n=80; HR 20.8; 95% CI 2.5-171.2). Independent risk factors for late vocal palsy were age, burden of morbidities, total thyroidectomy, post operative bleeding, male sex, and annual surgeon volume <30. CONCLUSIONS: There is a significant association between post-thyroidectomy vocal palsy and long-term risks of hospital readmission, dysphagia, hospitalisation for lower respiratory tract infection, and gastrostomy/tracheostomy tube placement. This adds weight to the need, from a thyroid surgical perspective, to undertake universal post-thyroidectomy laryngeal surveillance as a minimum standard of care, with a focus on post-operative dysphagia and aspiration, and from a medical/respiratory perspective, to initiate investigations to identify occult vocal palsy in patients who present with pneumonia, who have a history of thyroid surgery.

Discharge on the day of surgery following unicompartmental knee arthroplasty within the United Kingdom NHS.

AIMS: Unicompartmental knee arthroplasty (UKA) has been successfully performed in the United States healthcare system on outpatients. Despite differences in healthcare structure and financial environment, we hypothesised that it would be feasible to replicate this success and perform UKA with safe day of surgery discharge within the NHS, in the United Kingdom. This has not been reported in any other United Kingdom centres. PATIENTS AND METHODS: We report our experience of implementing a pathway to allow safe day of surgery discharge following UKA. Data were prospectively collected on 72 patients who underwent UKA as a day case between December 2011 and September 2015. RESULTS: A total of 61 patients (85%) were discharged on the same day. The most common reason for failure was logistical; five patients had their operation too late in the day. Three patients failed to mobilise safely, two had inadequate control of pain and one had a leaking wound. The mean length of stay for those who were not discharged on the same day was 1.2 nights (1 to 3). During the same time, 58 patients underwent planned inpatient UKA, as they were deemed inappropriate for discharge on the day of surgery. However, three of these were safely discharged on the same day. Follow-up data, 24 hours post-operatively, were available for 70 patients; 51 (73%) reported no or mild pain, 14 (20%) had moderate pain and five (7%) had severe pain. There were no re-admissions. All patients had a high level of satisfaction. CONCLUSION: We found that patients can be safely and effectively discharged on the day of surgery after UKA, with high levels of satisfaction. This clearly offers improved management of resources and financial savings to healthcare trusts. Cite this article: Bone Joint J 2017;99-B:788-92.

Impact of the method and success of pharyngeal reconstruction on the outcome of treating laryngeal and hypopharyngeal cancers with pharyngolaryngectomy: A national analysis.

BACKGROUND: Surgical treatment of cancers that arise from or invade the hypopharynx presents major reconstructive challenges. Reconstructive failure exposes the airway and neck vessels to digestive contents. METHODS: We performed a national N = near-all analysis of the administrative dataset to identify pharyngolaryngectomies in England between 2002 and 2012. Information about morbidity, pharyngeal closure method and post-operative complications was derived. RESULTS: There were 1589 predominantly male (78%) patients whose mean age at surgery was 62 years. The commonest morbidities were hypertension (24%) and ischemic heart disease (11%). For 232 (15%) patients, pharyngolaryngectomy was performed during an emergency admission. The pharynx was closed primarily in 551 patients, with skin or muscle free or pedicled flaps in 755 patients and with jejunum and gastric pull-up in 123 and 160 patients, respectively. In-hospital mortality rate was 6% and was significantly higher in the gastric pull-up group (11%). Reconstructive failure had an odds ratio of 6.2 [95% confidence interval (CI) 2.4-16.1] for in-hospital death. The five-year survival was 57% and age, morbidities, emergency surgery, gastric pull-up, major acute cardiovascular events, renal failure and reconstructive failure independently worsened prognosis. Patients who underwent pharyngeal reconstruction with radial forearm or anterolateral thigh flaps had lower mortality rates than patients who had jejunum flap reconstruction (hazard ratio = 1.50 [95% CI 1.03-2.19]) or gastric pull-up (hazard ratio = 1.92 [95% CI 1.32-2.80]). CONCLUSIONS: Pharyngolaryngectomy carries a high degree of risk of morbidity and mortality. Reconstructive failure worsens short- and long-term prognosis, and the use of cutaneous free flaps appears to improve survival.

A stratified analysis of the perioperative outcome of 17623 patients undergoing major head and neck cancer surgery in England over 10 years: Towards an Informatics-based Outcomes Surveillance Framework.

OBJECTIVES: To perform a national analysis of the perioperative outcome of major head and neck cancer surgery to develop a stratification strategy and outcomes assessment framework using hospital administrative data. DESIGN: A Hospital Episode Statistics N = near-all analysis. SETTINGS: The English National Health Service. MAIN OUTCOME MEASURES: Local audit data were used to assess and triangulate the quality of the administrative dataset. Within the national dataset, cancer sites, morbidities, social deprivation, treatment, complications, and in-hospital mortality were recorded. RESULTS: Within local audit datasets, the accuracy of assigning newly-derived Cancer Site Strata and Resection Strata were 92.3% and 94.2%, respectively. Accuracy of morbidities assignment was 97%. Within the national dataset, we identified 17 623 major head and neck cancer resections between 2002 and 2012. There were 12 413 males and mean age at surgery was 63 ± 12 years. The commonest cancer site strata were oral cavity (42%) and larynx-hypopharynx (32%). The commonest resection site was the larynx (n = 4217), and 13 211 and 11 841 patients had neck dissection and flap-based reconstruction, respectively. There were prognostically significant baseline differences between patients with oromandibular and pharyngolaryngeal malignancy. Patients with pharyngolaryngeal malignancies had a greater burden of morbidities, lower socio-economic status, fewer primary resections, and a sixfold increased risk of undergoing their major resection during an emergency hospital admission. Mean length of stay was 25 days and each complication linearly increased it by 9.6 days. There were 609 (3.5%) in-hospital deaths and a basket of seven medical and three surgical complications significantly increased the risk of in-hospital death. At least one potentially lethal complication occurred in 26% of patients. The risk of in-hospital death in a patient with no potentially lethal complication was 1.1% and this increased to 6% with one potentially lethal complication, and to 15.1% if two potentially lethal complications occurred in one patient. Complex oral-pharyngeal resections and pharyngolaryngectomies had the highest risks of complications and mortality. CONCLUSION: Mortality following head and neck cancer surgery shows variation across different resection strata. We propose an Informatics-based Framework for Outcomes Surveillance (IFOS) in Head and Neck Surgery for perpetual quality assurance, using the local hospital coding data or its collated destination, the national administrative dataset.