Role of cognitive function in assessing informed consent for endoscopy.

BACKGROUND: Patient understanding of the consent process is often suboptimal and the reasons for this are poorly understood. In particular the role of cognitive function in assessing the level of understanding of consent has not been evaluated. AIMS: This study aims to assess the level of patient understanding of the informed consent process and the role of cognitive function in those with low levels of understanding. METHODS: The study was prospective, interviewing patients immediately after they had given consent but before undergoing their procedure. Understanding of the reason for the procedure, the risks attendant upon it, details of the procedure itself and post procedure care was scored with the total representing overall level of understanding. A mini mental state examination (MMSE) was then performed with the score recorded. RESULTS: 100 patients were interviewed. A low level of understanding was shown in 36%. Ninety two patients had a MMSE score greater than 24. All patients with a high level of understanding had MMSE scores greater then 24 compared with 78% of those with a low level of understanding. All patients (n = 8) who displayed a MMSE score less than 24 had a low level of understanding. Men displayed poorer levels of understanding than women. A subnormal MMSE only identified 22% of those with low levels of understanding. CONCLUSIONS: Understanding of the consent process is suboptimal. Adequate cognitive function does not predict a high level of understanding of the informed consent process while cognitive impairment precludes it. It is evident, however that factors other than cognitive dysfunction are at play when attempting to explain low levels of understanding.

Absorption of delayed-release prednisolone in ulcerative colitis and Crohn's disease.

The absorption and urinary excretion of [3H]prednisolone after oral ingestion was examined using hard gelatin capsules with and without a coating of Eudragit-S which delayed release of the contents. In 6 patients with ulcerative colitis absorption was delayed until the preparation reached the colon but the total absorption was unchanged. In 6 patients with Crohn's disease and ileal strictures the preparation broke proximal to the stricture and absorption was delayed until this occurred (within 4-12 h). In 5 patients with Crohn's disease and intestinal resections the capsules broke unreliably.

Maintenance therapy for duodenal ulcer--a trial comparing cimetidine with a prostaglandin synthetase promoter.

The effect of treatment on maintenance of remission was examined in 90 patients with healed duodenal ulcer shown by endoscopy. They were randomized to take treatment for 6 months with a prostaglandin synthetase promoter (263E) 500 mg three times daily or cimetidine 400 mg at night or an identical placebo. Sixty-five patients completed the trial or had a relapse of symptoms. The percentage of patients who had recurrent ulcers or duodenitis alone on endoscopy was 29% on 263E, 36% with cimetidine, and 50% on placebo. These figures did not differ significantly. Trials of this design are now difficult to conduct because patients take and H2 receptor antagonist soon after recurrence of symptoms, before their next clinic appointment.

Gastric emptying after surgery for the dumping syndrome.

The dumping syndrome following gastric surgery for peptic ulcer disease can cause severe morbidity. In this study the benefit of interposition of an antiperistaltic jejunal loop to reverse peristalsis and delay gastric emptying was assessed in four patients with severe symptoms by performing gastric emptying studies pre-operatively, and at 6 months and 24 months following surgery. Gastric emptying was delayed at 6 months but by 2 years had returned to pre-operative values. Patients' symptoms were improved at 6 months and remained so despite the deterioration in gastric emptying. This surgical procedure is of some value to patients with severe symptoms due to the dumping syndrome.

Comparison of the absorption and metabolism of sulphasalazine and acrylic-coated 5-amino salicylic acid in normal subjects and patients with colitis.

Serum levels of 5-amino salicylic acid ( 5ASA ) and acetyl 5ASA have been measured in volunteers after ingestion of sulphasalazine (6 g) and compared with levels after an equivalent dose of acrylic coated 5ASA (2.4 g). The serum levels of both 5ASA and acetyl 5ASA were similar after each preparation apart from an early peak of 5ASA following acrylic coated 5ASA . Serum and urinary levels for 5ASA and acetyl 5ASA have been measured in colitic patients following equivalent doses of sulphasalazine and acrylic coated 5ASA . Serum levels were similar; 25% of the calculated ingested 5ASA was excreted in the urine after sulphasalazine compared with 20% following acrylic coated 5ASA .

Association between iron deficiency anaemia and mid-arm circumference in Crohn's disease.

The relation between nutritional anthropometry and haematological disturbance was studied in 55 outpatients with Crohn's disease and 30 healthy subjects. Patients with Crohn's disease were divided into undernourished (25) and well-nourished (30) groups, depending on whether their mid-arm circumference was below or above 90 per cent ideal standard. Undernourished patients with Crohn's disease had significantly reduced haemoglobin and red cell indices compared with well-nourished patients who were similar to the control group. In malnourished patients serum ferritin levels were usually below 50 micrograms/l and this level, rather than 15 micrograms/l indicates possible iron deficiency in patients with active inflammation. Results suggest that undernourished patients with Crohn's disease whose mid-arm circumference is less than 90 per cent ideal standard should be screened regularly for iron deficiency and anaemia.

Colonic release of 5-amino salicylic acid from an oral preparation in active ulcerative colitis.

5-amino salicylic acid coated with acrylic based resin was given orally to eight patients with active ulcerative colitis. Abdominal X-rays confirmed that the preparation released its contents in the terminal ileum and proximal colon. Differences between individuals were marked; the plasma 'concentration-time profile' reflected variations in the time taken for tablets to reach the terminal ileum.

Gastric emptying after intestinal resection in Crohn's disease.

Gastric emptying, using a liquid meal labelled with 99Tcm DTPA was studied in 6 patients with Crohn's disease who had diarrhoea following resection of the small intestine. Results were compared with those obtained in 6 normal subjects and 6 patients who had classic dumping symptoms following gastric surgery. The rate of gastric emptying of patients with Crohn's disease was similar to that of normal subjects, and differed markedly from gastric emptying in patients with the dumping syndrome (P less than 0 . 001). Diarrhoea in patients with Crohn's disease who have undergone intestinal resection is not due to rapid gastric emptying and would therefore be unlikely to respond to therapeutic measures designed to improve similar symptoms in patients who have the dumping syndrome.

An oral preparation to release drugs in the human colon.

1 A colonic delivery system is described to deliver orally ingested drugs to the colon and release them at that site by coating with an acrylic based resin (Eudragit S). The technique is validated using X-ray evidence and serum levels of a convenient marker, sulphapyridine. 2 This colonic delivery system is particularly suitable for drugs such as 5-amino salicylic acid or steroids in the management of patients with colitis.

Mortality in ulcerative colitis.

The pattern of mortality has been examined in a series of 676 patients with ulcerative colitis under long-term review to identify excesses or deficits in mortality for all causes of death in relation to the general population. The mortality risk for the whole series was 1.7 times that of the general population (p less than 0.001). Most of the excess mortality could be attributed to diseases of the digestive system. There was a heavy burden of mortality during the first year afer diagnosis and the first year after radical surgery. The significance of the excess of cancer deaths was due to the inclusion of patients who were diagnosed with cancer at first referral. In man there was a deficit of circulatory system deaths particularly those with early onset ulcerative colitis treated by panproctocolectomy after 40 yr of age. Mortality from all other causes including breast cancer showed no significant difference from that expected in the general population.