Blockchain Predictions for Health Care in 2021.

With coronavirus (COVID) spreading across the world and the health care system being pushed toward more digitization and technology, last year was a unique year of human tragedy. There is a silver lining to this tragedy, that is, providers, payers, and pharma companies have shifted quickly toward better technologies, including artificial intelligence (AI) blockchain, and so on.

De-intensified adjuvant (chemo)radiotherapy versus standard adjuvant chemoradiotherapy post transoral minimally invasive surgery for resectable HPV-positive oropharyngeal carcinoma.

BACKGROUND: More than 400,000 cases of oropharyngeal squamous cell cancer (OPSCC) are diagnosed every year worldwide and this is rising. Much of the increase has been attributed to human papillomavirus (HPV). HPV-positive OPSCC patients are often younger and have significantly improved survival relative to HPV-negative patients. Traditional management of OPSCC has been with radiotherapy with or without chemotherapy, as this was shown to have similar survival to open surgery but with significantly lower morbidity. Techniques have evolved, however, with the development of computerised planning and intensity-modulated radiotherapy, and of minimally invasive surgical techniques. Acute and late toxicities associated with chemoradiotherapy are a significant burden for OPSCC patients and with an ever-younger cohort, any strategies that could decrease treatment-associated morbidity should be investigated. OBJECTIVES: To assess the effects of de-intensified adjuvant (chemo)radiotherapy in comparison to standard adjuvant (chemo)radiotherapy in patients treated with minimally invasive transoral surgery (transoral robotic surgery or transoral laser microsurgery) for resectable HPV-positive oropharyngeal squamous cell carcinoma. SEARCH METHODS: The Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 26 April 2018. SELECTION CRITERIA: Randomised controlled trials (RCTs) in patients with carcinoma of the oropharynx (as defined by the World Health Organization classification C09, C10). Cancers included were primary HPV-positive squamous cell tumours originating from the oropharyngeal mucosa. Tumours were classified as T1-4a with or without nodal spread and with no evidence of distant metastatic spread. The intervention was minimally invasive transoral surgery followed by de-intensified adjuvant therapy (either omission of chemotherapy or reduced-dose radiotherapy). The comparator was minimally invasive transoral surgery followed by standard concurrent chemoradiotherapy or standard-dose radiotherapy. The treatments received were of curative intent and patients had not undergone any prior intervention, other than diagnostic biopsy. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. Our primary outcomes were overall survival (disease-related survival was to be studied where possible) and disease-free survival, measured at one, two, three and five years. Our secondary outcomes included assessment of swallowing ability and voice, measured at one, six, 12 and 24 months. We planned to use GRADE to assess the quality of evidence for each outcome. MAIN RESULTS: We did not identify any completed RCTs that met our inclusion criteria. However, three eligible studies are in progress:ADEPT is a phase III trial comparing postoperative radiotherapy with or without cisplatin in HPV-positive T1-4a OPSCC patients. Included patients must have received minimally invasive surgery and demonstrated extra-capsular spread from disease in the neck.ECOG-E3311 is a phase II trial of treatment for HPV-positive locally advanced OPSCC (stages III-IVa + IVb without distant metastasis). Patients are stratified after minimally invasive surgery. Medium-risk patients are randomised to either standard or reduced-dose radiotherapy.PATHOS is a phase III trial of treatment for HPV-positive OPSCC (T1-3, N0-2b). Patients are stratified after minimally invasive surgery. Medium-risk patients are randomised to either standard or reduced-dose radiotherapy. High-risk patients are randomised to radiotherapy with or without concurrent cisplatin. AUTHORS' CONCLUSIONS: This review highlights the current lack of high-quality randomised controlled trials studying treatment de-escalation after minimally invasive surgery in patients with HPV-positive OPSCC. However, trials that will meet the inclusion criteria for this review are in progress with results expected between 2021 and 2023.

Readability and quality assessment of internet-based patient education materials related to laryngeal cancer.

BACKGROUND: Patients are increasingly using the internet to access health-related information. The purpose of this study was to assess the readability and quality of laryngeal cancer-related websites. METHODS: Patient education materials were identified by performing an internet search using 3 search engines. Readability was assessed using Flesch Reading Ease Score (FRES), Flesch-Kincaid Grade Level (FKGL), and Gunning Fog Index (GFI). The DISCERN instrument was utilized to assess quality of health information. RESULTS: A total of 54 websites were included in the analysis. The mean readability scores were as follows: FRES, 48.2 (95% confidence interval [CI] = 44.8-51.6); FKGL, 10.9 (95% CI = 10.3-11.5); and GFI, 13.8 (95% CI = 11.3-16.3). These scores suggest that, on average, online information about patients with laryngeal cancer is written at an advanced level. The mean DISCERN score was 49.8 (95% CI = 45.4-54.2), suggesting that online information is of variable quality. CONCLUSION: Our study suggests much of the laryngeal cancer information available online is of suboptimal quality and written at a level too difficult for the average adult to read comfortably.

A prospective study of blood splatter in ENT.

Surgeons face an occupational risk of daily exposure to blood and body fluids. Potential sources of infection include sharps injuries and mucocutaneous contact. The transmission of blood-borne viruses, in particular human immunodeficiency virus (HIV), Hepatitis B and Hepatitis C from the patient to healthcare workers is well documented in the literature. We studied the incidence and degree of blood splash in all otolaryngology (ENT) procedures undertaken in a single unit over a 12 week period. In addition, we investigated which intraoperative factors might predict the degree of splash. We undertook a prospective, non-blinded study of 102 patients undergoing a range of 'routine' elective ENT within one department over 12 weeks. A surgical mask with visor attached was worn in all procedures. Following each procedure, all splatter masks were collected and examined macroscopically and microscopically for blood splash. In addition, the procedure performed, technique used, total blood loss, operating time and grade of surgeon was noted. 54% of procedures resulted in splash mask contamination. The median number of splash spots per mask was 4.7 (range 0-63). Tonsillectomy was the most commonly performed procedure, accounting for over one-third of total procedures investigated. Each mask had an average of 8.2 splash marks. Tonsillectomy had a splash rate of 76.9%. Although the risk of developing HIV is low the operating surgeon has a duty to take all precautions to protect themselves during a procedure and therefore a protective mask and visor or suitable goggles must be worn.

Lactococcus lactis cremoris infection: not rare anymore?

A middle-aged female patient with diabetes was admitted with a right neck abscess. Ultrasound scan revealed a necrotic abscess suspicious of malignancy and biopsy showed evidence of chronic inflammation. In order to isolate the primary source of malignancy, we performed MRI and positron emission tomography scans but neither had conclusive results. Subsequently, we performed an incision and drainage of the mass in order to alleviate pressure symptoms. The ensuing histological examination revealed that the mass was caused by Lactococcus lactis cremoris. As such, the patient was treated with antibiotics and made a complete recovery. This report reinforces the scarce existing evidence that L lactis cremoris is a potential pathogen in adults. The case shows that atypical organisms should always be considered in the working diagnosis of an atypical neck abscess especially due to the rise in popularity of organic farming.

Bulge in the tonsillar fossa. Is it a quinsy?

A young girl presented to the ENT acute clinic with a persistent cough and a bulge in the left oropharynx. As there were no clinical signs suggestive of a quinsy, an MRI was performed that showed a large mass extending from the base of the skull to the epiglottis medialising the lateral and posterior pharyngeal walls. The patient subsequently underwent an excision biopsy which demonstrated a ganglioneuroma, however developed a left-sided Horner's syndrome and mild vocal cord palsy after.

Severe hypo-osmotic hyponatraemia due to chylous leak following radical neck dissection.

Chylous leak is a documented complication of radical neck dissection with well recognised morbidities, including wound breakdown, hypovolaemia and hypoalbuminaemia. Other less well-documented electrolyte imbalances can also ensue. We aim to raise awareness about hypo-osmotic hyponatraemia as a potentially fatal, commonly overlooked complication of high-output chylous leaks. Following identification of his hyponatraemia, this patient underwent successful management in the intensive therapy unit, followed by surgical repair of his chylous leak. Hypo-osmotic hyponatraemia as a complication of chylous leak is not well documented, is likely to be overlooked when present, and is potentially life-threatening. It should be sought after in any patient with a high-output chylous leak following neck dissection.

Extramedullary plasmacytoma of the true vocal fold.

We report a rare case of extramedullary plasmacytoma (EMP) of the true vocal fold. Our patient, a 62-year-old woman, presented with dysphonia. On workup, fiberoptic laryngoscopy detected a lesion arising from the anterior half of her left true vocal fold. No evidence of other pathology was noted. The patient underwent radical radiotherapy, and the lesion resolved. Follow-up revealed no sign of recurrence. A type of myeloma, EMP is rare, especially in the larynx. To the best of our knowledge, our patient represents the sixth case of glottic EMP to be reported in the literature.

Follow-up in head and neck cancer: patients' perspective.

PURPOSE: The purpose of this paper is to determine head and neck cancer patients' perspective of their follow-up regime and to suggest ways in which these perspectives can be incorporated into current practice. DESIGN/METHODOLOGY/APPROACH: This is a prospective survey-based study. A total of 263 patients consecutively attending a head and neck cancer clinic completed a survey about their experience of the follow-up process in the post-treatment period between January 2009 and October 2009. FINDINGS: The paper finds that, of the patients, 67 per cent (n = 176) felt that the clinic met the goals they hoped would be achieved during their visit; 84 per cent (n = 221) felt that their follow-up visits were too frequent. In total 60 per cent (n = 159) were booked to see both an allied health professional and the attending clinician. Of these, 84 per cent (n = 134/159) felt that issues addressed at follow-up with the clinician duplicated those addressed by the allied healthcare professionals. When asked about their opinion of a less intensive follow-up system based on patients reporting problems and requesting appointments, 73 per cent (n = 192) favoured it. When asked who they would like to contact first in such a system, most patients (n = 118, 45 per cent) stated a clinical nurse specialist. PRACTICAL IMPLICATIONS: Current follow-up regimes may be too prescriptive in their approach without taking patient perspective into consideration. Patients felt that being seen intensively for the first year, then having visits tapered off over the next two years and finally being seen according to symptoms thereafter to be appropriate and felt that this represented an overall better system. ORIGINALITY/VALUE: These data suggest the need for a more patient-focused, individualised approach to follow-up in head and neck cancer.

Soft, fortified ice-cream for head and neck cancer patients: a useful first step in nutritional and swallowing difficulties associated with multi-modal management.

Patients with head and neck cancer have complex swallowing and nutritional concerns. Most patients are malnourished, and treatment modalities within the aerodigestive tract have profound effects on future swallowing and nutrition. The objective of this study is to investigate whether the introduction of fortified soft ice-cream to post-operative head and neck cancer patients would increase compliance with oral-feeding regimes. Using a questionnaire study, an ice-cream machine that produces fortified soft ice-cream was introduced onto our ward, and 30 patients were asked to fill out questionnaires based on their experience in addition to their oral-feeding regime. Results indicate that overall patient satisfaction and compliance with oral-feeding regimes increased: 77% felt that the taste was excellent and also felt that it was easy to eat; 60% felt that it eased the symptoms associated with their symptoms, in particular its cold temperature. We conclude from the results that the inability of patients undergoing multi-modal treatment for upper aerodigestive tract cancer to enjoy normal foods and its effects on their quality of life is underestimated. Providing a food to that is palatable, familiar and acceptable as it is safe and nutritionally sound can increase compliance with oral-feeding regimes. The ice-cream was safe to use in the early post-operative period, especially soothing in patients undergoing upper aerodigestive radiotherapy and high in protein and calorific content. Our practice may have wider benefits, including patients with oral and oropharyngeal infections, the elderly and patients with neurological dysphagia resulting from stroke.

Relation of study design to recruitment and retention in CTN trials.

BACKGROUND: Recruitment and retention in randomized clinical trials are difficult in general and particularly so in trials of substance abuse treatments. Understanding trial design characteristics that could affect recruitment and retention rates would help in the design of future trials. OBJECTIVE: To test whether any of the following factors are associated with recruitment or retention: type of intervention, type of therapy, duration of treatment, total duration of trial, number of treatment sessions, number of follow-up visits, number of primary assessments, timing of primary assessments, number of case report form (CRF) pages at baseline, and number of CRF pages for the entire trial. METHODS: Recruitment and retention data from 24 Clinical Trials Network (CTN) trials conducted and completed between 2001 and 2010 were analyzed using single-factor analysis of variance and single-predictor regression methods to test their association with trial design characteristics. RESULTS: Almost all of the analyses performed did not show statistically significant patterns between recruitment and retention rates and the trial design characteristics considered. CONCLUSION: In CTN trials, the relationship between assessment burden on participants and length of trial, on the one hand, and recruitment and retention, on the other, is not as strong and direct as expected. Other factors must impinge on the conduct of the trial to influence trial participation. SCIENTIFIC SIGNIFICANCE: Researchers may deem slightly more justifiable to permit inclusion of some of the design features that previously were assumed to have a strong, negative influence on recruitment and retention, and should consider other strategies that may have a stronger, more direct effect on trial participation.

Strategies for safety reporting in substance abuse trials.

BACKGROUND: Reporting all adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials has yielded limited relevant safety information and has been burdensome to research sites. OBJECTIVE: This article describes a new strategy utilizing standard data elements for AE and SAEs that defines a threshold to reduce unnecessary safety reporting burden in SUD clinical trials and describes retrospective review and prospective preliminary data on the strategy's safety reporting impact. METHODS: We developed a new strategy to standardize safety reporting and tailor reporting to the trial intervention risk. Protocols and safety data from 17 SUD clinical trials were reviewed. Retrospective analysis of five of these studies and prospective application to new studies is described. RESULTS: Across the 17 previously completed trials, a total of 11,220 AEs and 1330 SAEs were reported in the 6737 participants. Wide variability in AE and SAE reporting rates were noted based on trial type and inconsistent reporting strategies. Application of the new, tailored safety strategy retrospectively and prospectively reduces reporting burden of irrelevant safety events. CONCLUSION: Comparison of the previous reporting strategies used in SUD trials to the new strategy demonstrates a more consistent safety system with a reduction in safety reporting burden while maintaining appropriate safety monitoring. SCIENTIFIC SIGNIFICANCE: Safety assessments should be tailored to the participant risks based on the trial intervention. The current strategies could be applied to safety assessments across all clinical trials in SUDs.

Role of tonsillectomy in the search for a squamous cell carcinoma from an unknown primary in the head and neck.

Cervical metastases of an unknown primary lesion accounts for 5%-10% of head and neck cancers. Tonsillar carcinoma is the third most common, with an incidence in the region of 18%-47% of unknown primaries, and the likelihood of synchronous tonsillar tumour of about 5%-10%. Current practice for investigating an unknown primary includes computed tomography (CT) with or without magnetic resonance imaging (MRI), and then, if necessary, 18-fluoro-deoxy-glucose positron emission tomography (FDG-PET). This is followed by panendoscopy with biopsy from the potential primary sites and tonsillectomy. A five-year retrospective review of our database of metastatic squamous cell carcinomas from unknown primary sites identified patients with synchronous tonsillar tumours (n=5). All had clinically normal-looking tonsils; MRI was within normal limit and a PET-CT identified the ipsilateral tonsillar primary in three cases only. Bilateral tonsillectomy rather than a tonsillar biopsy in the search for an unknown primary has been standard practice in our unit. Identification of a second primary dictates planning for the primary site and in the long term, influences patients' survival. We therefore recommend that bilateral tonsillectomy should be standard in the investigation of patients who present with cervical metastases from an unknown primary in the head and neck region.

Thyroglossal duct cyst masquerading as a haematoma.

Thyroglossal duct cysts most frequently present in childhood as painless midline swellings around the level of the hyoid. Classically the cyst moves upwards on protruding the tongue. Here we report a novel case of a thyroglossal cyst in an adult in whom the history, examination and fine needle aspiration cytology were typical of a traumatic haematoma. This case is also unique because the thyroglossal duct cyst extended beyond the thyroid gland to the suprasternal notch and actually required two parallel transverse cervical incisions for its complete en bloc removal.

Submandibular neurilemmoma; a diagnostic dilemma.

Neurilemmomas are slow growing, benign neoplasms of neural crest Schwann cell origin. They arise from any peripheral, spinal or cranial nerve except the olfactory and optic. Presentation is usually asymptomatic but focal neurological signs and symptoms may be associated with nerve compression. With approximately one third of all documented cases presenting in the head and neck region, we report a case of a submandibular neurilemmoma misdiagnosed pre-operatively. The diagnostic difficulties are discussed and the current literature reviewed. This case highlights the importance of inclusion of nerve sheath tumours in differential diagnoses of soft tissue lesions in the head and neck.