Recruitment of patients into head and neck clinical trials: acceptability of studies to patients from perspective of the research team.

We reviewed longitudinal recruitment data to assess recruitment into head and neck cancer trials, and to identify factors that could influence this and affect their acceptability to patients. We retrieved data from the prospective computerised database (2009-2016) to measure acceptability to patients using the recruitment:screening ratio, and compared observational with interventional studies, single specialty (or site) with multispecialty (or site) studies, and "step-up" randomisation with "non-inferiority" randomisation designs. A total of 1283 patients were screened and 583 recruited. The recruitment:screening ratio for all National Institute for Health Research (NIHR) portfolio studies combined was 0.47 (486/1133). Studies that involved treatment by several specialties or at several sites had a significantly adverse impact on acceptability (p=0.01). Recruitment into non-inferiority randomised controlled studies was lower than that into step-up randomised studies (p=0.06). The complexity of a study's design did not compromise recruitment. Treatment across several specialties or several sites and perceived non-inferiority designs, reduced the acceptability of some trials.

Changes in facial form relative to progressive atrophy of the edentulous jaws.

The surgical and prosthodontic rehabilitation of the edentulous patient aims to restore oral function and facial form. Planning treatment requires an understanding of the effect of progressive jaw atrophy, and the concomitant effect on the soft tissues of the face. This study examined 179 Caucasians at different stages of jaw atrophy according to the Cawood and Howell classification; various standard anthropological measurements of the face, according to Farkas, were also taken. We have demonstrated that changes in the soft tissues are related to the degree of underlying jaw atrophy. This has important implications when planning surgical and prosthodontic rehabilitation of the edentulous patient. Early stages of jaw atrophy (Class II, III & IV) result in the collapse of the circumoral musculature causing a narrowing of the mouth, loss of lip support, inversion of the lips and contraction of the cheeks. Late changes of jaw atrophy (Class V & VI) result in changes in vertical facial proportion causing a decrease in lower facial height and an increase in chin prominence. These late skeletal changes accentuate the earlier soft tissue facial effects.

The prognostic implications of the surgical margin in oral squamous cell carcinoma.

The prime objective of tumour ablation in oral squamous cell carcinoma (OSCC) is the removal, with a 'margin' of normal tissue, of the whole tumour. Definition of what constitutes margin involvement varies. This study aims to examine the factors associated with close and involved surgical margins in the management of OSCC. A cohort of 200 consecutive patients with previously untreated OSCC provided the material for the study. Various clinical, operative and pathological parameters were related to the status of the surgical margin, as well as time to recurrence, and survival. Cox regression analysis of the survival was also undertaken. Of the 200 patients 107 (53.5%) had clear margins, 84 (42%) close and 9 (4.5%) involved. Poor correlation was found between the status of the surgical margin and clinical factors, but in contrast high correlation between histological indicators of aggressive disease and close or involved surgical margins. These results imply that close surgical margins in OSCC could be regarded as an indictor of aggressive disease.

Learning curve for oesophageal cancer surgery.

BACKGROUND: Surgical training and experience are frequently claimed to influence early and late outcome measures. The aim of this study was to examine any improvement in an individual surgeon's performance in one operation over a period of 7 years from initial appointment to date. METHODS: Patients undergoing Ivor Lewis subtotal oesophagectomy performed by a single surgeon between April 1990 and December 1996 were identified from a prospectively compiled oesophageal cancer database. Operating time (abdominal, thoracic and 'one-lung time'), blood loss, transfusion requirements (intraoperative and total), extent of lymphadenectomy (number of lymph nodes sampled), intensive treatment unit (ITU) stay, hospital stay, postoperative morbidity and mortality, pathological stage, grade and survival were recorded. RESULTS: The records of 150 patients were identified for analysis. The cohort was split into five groups, each of 30 patients operated on consecutively. Each of the groups was comparable for age, sex, smoking history, preoperative haemoglobin and creatinine levels, weight loss, American Society of Anesthesiologists' grade, and histological stage and grade of disease. Analysis of the variables pertaining to operation revealed a significant improvement with time including reduced single-lung operating time (P=0.01), reduced blood loss (P=0.03), reduced transfusion requirement (P < 0.0001), reduced ITU stay (P< 0.0001), reduced inpatient stay (P< 0.0001) and an increased yield of lymph nodes (P < 0.0001). CONCLUSION: This study showed a continuing improvement in a surgeon's performance over a 7-year period. With the current trend to shorter training periods there is a case for continuing supervision of the 'fully trained' surgeon within highly specialist units.

Anaesthetic management of renin secreting nephroblastoma.

We report the successful preoperative control and anaesthetic management of severe hypertension in a 7-month-old baby with nephroblastoma and increased renin activity. The strategy for selection of appropriate antihypertensive pharmacological agents and the anaesthetic implications and management of the condition are discussed.

Depth of extradural space and dural puncture.

The records of 3011 obstetric extradural blocks were examined to determine the depth of the extradural space and the relative risk of dural puncture. The overall incidence of dural puncture was 0.7%. A disproportionate number of punctures occurred when the space was superficial (1.45%), with a risk factor three times greater than that associated with normal depth spaces (0.48%). Caution is advised when infiltrating with local anaesthetics before extradural procedures, and when initially introducing the extradural needle.

Management of autonomic dysfunction in severe tetanus: the use of magnesium sulphate and clonidine.

The treatment of severe tetanus with autonomic dysfunction is discussed, with emphasis on the use of magnesium sulphate. An exemplary case is reported, describing the inadequate response to magnesium, but the previously unreported and successful use of clonidine to control sympathetic overactivity. The properties of clonidine are reviewed. Clonidine is felt to be a logical and appropriate drug for the treatment of autonomic dysfunction in severe tetanus.

The effect of fentanyl on propofol requirements for day case anaesthesia.

Fifty women of ASA grade 1 or 2 scheduled to undergo minor gynaecological procedures were allocated randomly to two groups. Group A received fentanyl 100 micrograms intravenously before induction; group B received no sedative or analgesic drugs. Anaesthesia was induced with propofol intravenously and maintained using 67% nitrous oxide in oxygen with incremental doses of propofol. Induction time and dose were significantly less and mean arterial pressure decreased significantly lower in Group A. These differences were, however, small and the ranges of values were large. The incidence of side effects and subjective assessment of quality of anaesthesia were similar in both groups. Fentanyl did not confer any practical advantage when used with propofol in the techniques described above.

Pneumatosis cystoides intestinalis. Nitrous oxide anaesthesia and the rapid effect of oxygen therapy.

A case of pneumatosis cystoides intestinalis discovered at laparotomy for a perforated duodenal ulcer is described. Nitrous oxide administration is contra-indicated in this condition, and the rapid effectiveness of 100% oxygen administration is observed during the surgical procedure.