Implementing core NICE guidelines for osteoarthritis in primary care with a model consultation (MOSAICS): a cluster randomised controlled trial.

OBJECTIVE: To determine the effectiveness of a model osteoarthritis consultation, compared with usual care, on physical function and uptake of National Institute for Health and Care Excellence (NICE) osteoarthritis recommendations, in adults ≥45 years consulting with peripheral joint pain in UK general practice. METHOD: Two-arm cluster-randomised controlled trial with baseline health survey. Eight general practices in England. PARTICIPANTS: 525 adults ≥45 years consulting for peripheral joint pain, amongst 28,443 population survey recipients. Four intervention practices delivered the model osteoarthritis consultation to patients consulting with peripheral joint pain; four control practices continued usual care. The primary clinical outcome of the trial was the SF-12 physical component score (PCS) at 6 months; the main secondary outcome was uptake of NICE core recommendations by 6 months, measured by osteoarthritis quality indicators. A Linear Mixed Model was used to analyse clinical outcome data (SF-12 PCS). Differences in quality indicator outcomes were assessed using logistic regression. RESULTS: 525 eligible participants were enrolled (mean age 67.3 years, SD 10.5; 59.6% female): 288 from intervention and 237 from control practices. There were no statistically significant differences in SF-12 PCS: mean difference at the 6-month primary endpoint was -0.37 (95% CI -2.32, 1.57). Uptake of core NICE recommendations by 6 months was statistically significantly higher in the intervention arm compared with control: e.g., increased written exercise information, 20.5% (7.9, 28.3). CONCLUSION: Whilst uptake of core NICE recommendations was increased, there was no evidence of benefit of this intervention, as delivered in this pragmatic randomised trial, on the primary outcome of physical functioning at 6 months. TRIAL REGISTRATION: ISRCTN06984617.

Pattern of breathing during upper gastrointestinal endoscopy: implications for administration of supplemental oxygen.

Cardiopulmonary complications account for half the deaths associated with upper gastrointestinal endoscopy. The incidence of hypoxia at the time of upper gastrointestinal endoscopy can be greatly reduced by the administration of supplemental oxygen via nasal cannulae. Using dual thermistors in the mouth and nostrils of patients undergoing upper gastrointestinal endoscopy, the present study demonstrates that most patients breathe predominantly via the oral, rather than the nasal, route following intubation of the oesophagus. The implication from the study is that, if supplemental oxygen is to be used in 'at risk' patients, it would be logical to employ an oral, rather than nasal, route of administration.

Bolus or slow titrated injection of midazolam prior to upper gastrointestinal endoscopy? Relative effect on oxygen saturation and prophylactic value of supplemental oxygen.

A total of 131 patients undergoing upper gastrointestinal endoscopy were sedated with midazolam given as a bolus injection over 5 seconds. The oxygen saturation was continuously measured using a pulse oximeter. Supplemental oxygen was given via nasal cannulae at a rate of 3 litres per minute to 54 patients, while the remaining 77 patients only received oxygen if their oxygen saturation dropped below 85%. Both groups in the present series were compared with 3 previously published series of patients, in whom we had used intravenous midazolam as a slow titrated injection. Despite using on average only two-thirds of the dose of midazolam, following bolus injection the degree of oxygen desaturation during the endoscopic procedure was greater, and the ability of supplemental oxygen delivered via nasal cannulae to prevent hypoxia was less (P less than 0.01), than with a slow titrated injection.

Omeprazole and Helicobacter pylori: temporary suppression rather than true eradication.

Twenty-four Helicobacter pylori (H. pylori)-positive patients were treated for 28 days with either 20 mg omeprazole o.m. (n = 12) or 40 mg omeprazole o.m. (n = 12). Clearance (absence of H. pylori at the end of or shortly after treatment) and eradication (absence of H. pylori 1 month after cessation of treatment) were assessed using the 14C-urea breath test. Observed clearance and eradication were: 20 mg omeprazole 3/12 and 0/12; 40 mg omeprazole 6/12 and 1/12 respectively. The effect on H. pylori is probably due to the change in gastric pH from acid to neutral, however it is insufficient to recommend the inclusion of omeprazole in regimens aimed at eradicating H. pylori.

Helicobacter pylori: treatment with combinations of pivampicillin and tripotassium dicitrato bismuthate.

Fifty Helicobacter pylori- (H. pylori) positive patients entered an open study and were assigned to one of four treatment regimens comprising: pivampicillin (500 mg b.d.) for 2 weeks +/- tripotassium dicitrato bismuthate (tablet or liquid form) for one month. The 14C-urea breath test was used to evaluate clearance (negative at the end of treatment) and eradication (negative at 1 month post-treatment) of H. pylori. Clearance rates were 20% (2/10) after pivampicillin alone, 86% (12/14) after tripotassium dicitrato bismuthate tablets (240 mg b.d.) plus pivampicillin, 67% (6/9) after tripotassium dicitrato bismuthate tablets (120 mg q.d.s.) plus pivampicillin, and 100% (13/13) after tripotassium dicitrato bismuthate liquid (120 mg in 5 ml q.d.s) plus pivampicillin. The eradication rates were 0% (0/10), 13% (2/15), 0% (0/11) and 54% (7/13), respectively. Combination of the results from the 2 tripotassium dicitrato bismuthate tablet/pivampicillin groups gave an eradication rate of 7.7% (2/26) which was significantly lower than the 53.9% (7/13) obtained with tripotassium dicitrato bismuthate liquid/pivampicillin (P less than 0.02). In conclusion, a liquid tripotassium dicitrato bismuthate pivampicillin combination may be of special use in the treatment of H. pylori-positive patients when triple therapy is contraindicated (e.g. patient sensitivity/allergy to metronidazole) or when the H. pylori isolate is resistant to metronidazole.

Helicobacter pylori infection treated with a tripotassium dicitrato bismuthate and metronidazole combination.

Seventy-two patients with H. pylori infection in their antral mucosa took part in the study. Forty-three received metronidazole 400 mg t.d.s. for two weeks, plus De-Nol tabs 2 b.d. for four weeks, and the remaining 29 patients received metronidazole 400 mg t.d.s. for two weeks plus De-Nol liquid 5 ml q.d.s. for four weeks. Seven of 57 H. pylori isolates were found to have pre-treatment metronidazole resistance. Success, in terms of eradication of H. pylori, was assessed using a one-month post-treatment 14C urea breath test. Successful eradication of H. pylori was achieved in 72% and 79%, respectively, of the metronidazole/De-Nol tablet and metronidazole/De-Nol liquid groups. These figures increased to 87% and 84%, respectively, if the patients whose organisms were known to be metronidazole-sensitive were considered in isolation. H. pylori was successfully eradicated in only one of seven patients with a metronidazole-resistant organism.

A comparison of winged steel needles and Teflon cannulas in maintaining intravenous access during gastrointestinal endoscopy.

We have conducted a prospective study in 142 consecutive patients undergoing either gastroscopy or colonoscopy. The patients were randomized to have either a 23-gauge winged steel needle or a 23-gauge Teflon cannula inserted. The two groups were well matched, with 71 patients receiving each device. Intravenous access was achieved in every case. The steel needle was inserted at the first attempt in 65 of 71 cases (91.6%) compared with 67 of 71 cases (94.4%) for the Teflon cannula. Extravasation occurred in only 1 of 71 cases (1.4%) with Teflon cannulas compared with 18 of 71 cases (25.5%) of steel needle use (p < 0.01). Additionally, no Teflon cannula blocked completely, whereas 1 of 71 steel needles (1.4%) did so. Only 1 of 71 (1.4%) of the Teflon cannulas became difficult to flush compared with 12 of 71 steel needles (16.9%). The Teflon cannula was as easy to insert and provided significantly more reliable intravenous access than the steel needle.

Prevention of hypoxaemia during upper-gastrointestinal endoscopy by means of oxygen via nasal cannulae.

Hypoxaemia during oesophagogastroduodenoscopy is well documented and contributes to cardiac arrhythmias and occasional deaths from endoscopy. In 50 patients sedated with intravenous midazolam and examined with a large-diameter endoscope, oxygen desaturation was abolished by giving oxygen (2 litres/min) by way of nasal cannulae throughout the procedure.

Intravenous midazolam for upper gastrointestinal endoscopy: a study of 800 consecutive cases relating dose to age and sex of patient.

In many endoscopy units midazolam is replacing diazepam as the intravenous sedative of first choice. Midazolam is approximately twice as potent as diazepam. Although generally considered a safe drug, there have been a number of recent reports, particularly in the elderly, of the drug causing hypotension, respiratory depression and even death. There have been at least ten studies comparing diazepam with midazolam for upper gastrointestinal endoscopy but many have involved relatively small numbers and none have adequately addressed the question of dosage in the elderly. We have carefully recorded the dose of intravenous midazolam used to produce adequate sedation prior to upper gastrointestinal endoscopy in 800 consecutive patients. The dose of midazolam decreased markedly with age in both male and female patients. There was a highly significant correlation in both sexes between age and the dose of midazolam (rho -0.787, P less than 0.001 for males and rho -0.768, P less than 0.001 for females). There was only a small difference in dose in men and women, an average of 1 mg; and no difference in dose over the age of 70 years. In patients over 70 years of age the dose of midazolam necessary for endoscopy is often so small that overdosage is all too easy.

A comparison of diazepam and midazolam as endoscopy premedication assessing changes in ventilation and oxygen saturation.

1. One hundred and two consecutive patients undergoing upper gastrointestinal endoscopy were randomised to be sedated with either intravenous diazepam (Diazemuls-Kabi Vitrum) or intravenous midazolam (Hypnovel-Roche). It was assumed that midazolam was likely to be approximately twice as potent as diazepam on the basis of previous work. 2. All patients had an ear oximeter attached throughout the procedure to record continuously their level of oxygen saturation. 3. All 102 patients had pre-endoscopy respiratory function tests measured and 100 wore an induction plethysmograph vest to allow continuous estimation of respiratory rate and excursion. The plethysmograph was calibrated using a pneumotachygraph, so baseline, post-injection and post-endoscopy minute volumes could be estimated. 4. The age, sex ratio and pre-endoscopy respiratory function tests of the 51 patients given intravenous diazepam in a mean dose (s.d.) of 11.5 (5.8) mg over a mean of 3.4 (0.9) min) were similar to that of the 51 patients sedated with intravenous midazolam (mean dose 6.0 (2.8) mg over 3.3 (0.9) min. 5. Both drugs significantly reduced minute volume (P less than 0.001) and oxygen saturation (P less than 0.001). Midazolam appeared to produce slightly greater hypoxaemia with 57% having falls in oxygen saturation of greater than 2.5% compared with only 35% given an equivalent dose of diazepam. 6. Ventilation was still less than baseline when re-checked some minutes after removal of the gastroscope. The speed of recovery appeared faster after diazepam sedation which is in contrast to its longer pharmacological half-life.(ABSTRACT TRUNCATED AT 250 WORDS)

Speed of reversal of midazolam-induced respiratory depression by flumazenil--a study in patients undergoing upper G.I. endoscopy.

Intravenous midazolam was given to 17 patients coming to upper G.I. endoscopy. All patients had an ear oximeter and calibrated induction plethysmograph attached to record oxygen saturation and minute volume continuously. Midazolam induced significant depression of respiration. Following removal of the endoscope, a new base line was obtained before giving intravenous flumazenil in an attempt to reverse the sedative and ventilatory effects of midazolam. When 0.5 mg of flumazenil was given over 20 s, followed by 0.1 mg every minute, up to a total of 1.0 mg, all patients were apparently awake in under 2 min. Although the flumazenil had clearly reversed the sedative effects of midazolam, the ventilatory effects were largely uninfluenced. The implications are discussed.

Small bolus injections of intravenous midazolam for upper gastrointestinal endoscopy: a study of 788 consecutive cases.

1 A recent audit of upper gastrointestinal endoscopy carried out by the Royal College of Surgeons of England has shown that the majority of endoscopists use a bolus injection rather than a slow intravenous titration of benzodiazepine for intravenous sedation. In this study we have confirmed the theoretical premise that a reduced dose of midazolam is required when given as a bolus. A mean dose of 4.65 mg midazolam intravenously has been found to be effective and safe in sedating patients under 70 years (n = 552). The dose of midazolam needed is reduced in older patients: patients over 70 years (n = 236) needed a mean dose of 1.89 mg. 2 Topical pharyngeal anaesthesia was not required with these doses of midazolam, and it was our impression that the examination was equally well tolerated with a similar degree of anterograde amnesia as in the previous study. 3 Our data, together with the results of the audit, would suggest many endoscopists are employing unnecessarily large and at times potentially dangerous doses of intravenous sedation in elderly patients and that the vast majority of upper gastrointestinal endoscopies can be performed successfully, without topical pharyngeal anaesthesia, using a bolus injection techniquewith a reduced dosage of sedative agent.

Intravenous midazolam: a study of the degree of oxygen desaturation occurring during upper gastrointestinal endoscopy.

Intravenous midazolam (mean dose of 6.3 mg) was given to 100 consecutive patients coming to endoscopy. All patients had an ear oximeter attached throughout the procedure to record continuously their levels of oxygen saturation. Eighty-five of the 100 patients had pre-endoscopy respiratory function tests measured, and 82 wore an induction plethysmograph vest to get a continuous qualitative estimate of respiratory rate and excursion throughout the procedure. Following intravenous midazolam a reduction in respiratory excursion was observed in 80% of patients. The initial baseline oxygen saturation of 95.4% fell 3.3% (P less than 0.0005) following intravenous midazolam to 92.1%. During the endoscopic procedure there was a further 3.1% decrease in oxygen saturation to 89.0% (P less than 0.0005) and in 7% the level fell to below 80%. Age, sex, dose of midazolam given and pre-endoscopy respiratory function tests failed to identify those patients at risk of hypoxia during the endoscopy.

Upper gastrointestinal endoscopy: a prospective randomized study comparing continuous supplemental oxygen via the nasal or oral route.

We have examined the efficacy of supplemental oxygen in preventing episodes of significant arterial desaturation (SpO2 less than 90%) during upper gastrointestinal endoscopy. We have compared the effects of 2 liters.min-1 of oxygen given orally via the bite-guard with the same flow rate via nasal cannulas and have also examined the effects of pre-oxygenation. Results of this study at a flow rate of 2 liters.min-1 have been compared with previously published results at a flow rate of 3 liters.min-1. Although in this study fewer episodes of desaturation were seen in the orally supplemented group compared with the nasal group, the difference observed was not statistically significant. Pre-oxygenation significantly reduced episodes of desaturation (SpO2 less than 90%, p less than 0.01) and prevented SpO2 falls below 85% in all patients studied. Supplemental oxygen given at a rate of 2 liters.min-1 was as effective as that given at a rate of 3 liters.min-1 in preventing significant desaturation, as previously defined, during the procedure. We therefore recommend the use of supplemental oxygen at a flow rate of 2 liters.min-1 in all high risk patients and conclude that the oral route has practical advantages and is at least as effective as nasal cannulas.