EVerT: cryotherapy versus salicylic acid for the treatment of verrucae--a randomised controlled trial.

OBJECTIVE: To compare the clinical effectiveness and cost-effectiveness of cryotherapy using liquid nitrogen versus patient daily self-treatment with 50% salicylic acid for the treatment of verrucae (plantar warts). DESIGN: A multicentre, pragmatic, open, two-armed randomised controlled trial with an economic evaluation. Randomisation was simple, with the allocation sequence generated by a computer in a 1 : 1 ratio. SETTING: Podiatry clinics, university podiatry schools and primary care in England, Scotland and Ireland. PARTICIPANTS: Patients were eligible if they presented with a verruca which, in the opinion of the health-care professional, was suitable for treatment with both salicylic acid and cryotherapy, and were aged 12 years and over. INTERVENTIONS: Cryotherapy using liquid nitrogen delivered by a health-care professional compared with daily patient self-treatment with 50% salicylic acid (Verrugon, William Ransom & Son Plc, Hitchin, UK) for a maximum of 8 weeks. MAIN OUTCOME MEASURES: The primary outcome was complete clearance of all verrucae at 12 weeks. Secondary outcomes were complete clearance of all verrucae at 12 weeks, controlling for age, whether or not the verrucae had been previously treated and type of verrucae, with a second model to explore the effect of patient preferences, time to clearance of verrucae, clearance of verrucae at 6 months, number of verrucae at 12 weeks and patient satisfaction with the treatment. RESULTS: In total, 240 eligible patients were recruited, with 117 patients allocated to the cryotherapy group and 123 to the salicylic acid group. There was no evidence of a difference in clearance rates between the treatment groups in the primary outcome [17/119 (14.3%) in the salicylic acid group vs 15/110 (13.6%) in the cryotherapy group; p = 0.89]. The results of the study did not change when controlled for age, whether or not the verrucae had been previously treated and type of verrucae, or when patient preferences were explored. There was no evidence of a difference in time to clearance of verrucae between the two groups [hazard ratio (HR) 0.80, 95% confidence interval (CI) 0.51 to 1.25; p = 0.33] or in the clearance of verrucae at 6 months (33.7% cryotherapy vs 30.5% salicylic acid). There was no evidence of a difference in the number of verrucae at 12 weeks between the two groups (incidence rate ratio 1.08, 95% CI 0.81 to 1.43; p = 0.62). Nineteen participants reported 28 adverse events, 14 in each group, with two treatment-related non-serious adverse events in the cryotherapy group. Cryotherapy was also associated with higher mean costs per additional healed patient (£101.17, 95% bias-corrected and accelerated CI £85.09 to £117.26). The probability of cryotherapy being cost-effective is 40% for a range of willingness-to-pay thresholds of £15,000-30,000 per patient healed. CONCLUSIONS: There is no evidence for a difference in terms of clearance of verrucae between cryotherapy and salicylic acid (at both 12 weeks and 6 months), number of verrucae at 12 weeks and time to clearance of verrucae. Cryotherapy was associated with higher mean costs per additional healed patient compared with salicylic acid. TRIAL REGISTRATION: Current Controlled Trials ISRCTN18994246. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 15, No. 32. See the HTA programme website for further project information.

A review of the literature on topical therapies for diabetic foot ulcers. Part 2: Advanced treatments.

Following part one, which presented background to diabetic foot ulcers and the principles thought to explain hard-to-heal wounds, part two of this series reviews the efficacy and cost data indicating that certain wound treatments may be of benefit.

Topical therapies for diabetic foot ulcers: standard treatments.

This paper is the first in a two-part series reviewing the evidence on standard and advanced treatments for diabetic foot ulcers. Both clinical studies and economic models are evaluated. The first part concentrates on standard topical therapies.

Is multidisciplinary learning effective among those caring for people with diabetes?

The role of multi-professional learning for those providing clinical services to people with diabetes has yet to be defined. Several assumptions are generally made about education in the context of multi-professional settings. It is argued that different professions learning together could potentially improve professional relationships, collaborative working practices and ultimately standards of care. Greater respect and honesty may emerge from a team approach to learning with a commensurate reduction in professional antagonism. Personal and professional confidence is reportedly enhanced through close contact with other professionals during team-based learning exercises. We have examined current evidence to support multidisciplinary learning in the context of medical education generally as well as in diabetes education. Previous investigation of available literature by Cochrane reviewers, aimed at identifying studies of interprofessional education interventions, yielded a total of 1042 articles, none of which met the stated inclusion criteria. Searches involving more recent publications failed to reveal more robust evidence. Despite a large body of literature on the evaluation of interprofessional education, studies generally lacked the methodological rigour needed to understand the impact of interprofessional education on professional practice and/or health care outcomes. Nevertheless, planners continue to advocate, and endorse, joint training between different groups of workers (including nurses, doctors and those in professions allied to medicine) with the objective of producing an integrated workforce of multidisciplinary teams. Whilst the concept of multi-professional learning has strong appeal, it is necessary for those responsible for educating health care professionals to demonstrate its superiority over separate learning experiences.

Retrospective collection of exposure data from industry: results from a feasibility study in the United Kingdom.

In the United Kingdom the Health and Safety Executive for some years has stored chemical exposure data in their National Exposure Database. However, it has been difficult to persuade industry and other organizations to contribute to this resource. The aim of this project was to devise a cost-effective method of obtaining occupational exposure data on chemicals from U.K. industry and other sources. Five strategies were used to identify data for three different substances: toluene, acrylonitrile, and ethylene oxide. In total, 810 organizations were contacted and over 45 percent responded. However, only 40 had relevant exposure data. Almost equal numbers of acceptable measurements were identified for toluene and acrylonitrile (2,770 and 2,000 respectively) with lesser ethylene oxide data (800). These measurements were drawn from a wide range of industries and are probably representative of measurements made by U.K. industry, although most of the data were from companies employing more than 100 people. During the second phase of the project, more than 3,000 measurements and associated contextual information were collected (499 for toluene, 1,516 for acrylonitrile, and 17 for ethylene oxide, with a further 1,004 measurements for 1 of 27 substances collected simultaneously with one of the above). The costs of identifying and collecting exposure data ranged from l7 to l380 per valid measurement, depending on the source of the data. We suggest that, rather than trying to retrospectively collect data, it is likely to be more cost-effective to enlist a number of occupational hygiene consults and industrial organizations to prospectively provide anonymized exposure measurements for inclusion in the Health and Safety Executives National Exposure Database.

Can the urea breath test for H.pylori replace endoscopy for the assessment of dyspepsia in primary care?

AIMS: The urea breath test may have value in the initial assessment of dyspepsia in primary care. This pilot study tracks patient and general practitioner behaviour which cannot be predicted with modelling studies. METHODS: The urea breath test was made available over a period of 18 months. The test was requested when general practitioners would normally have used a trial of medication or referred for endoscopy. Patients with a positive urea breath test had early endoscopy before treatment. Patients with a negative urea breath test were treated according to symptom response. A follow-up questionnaire was given 6-24 months after the urea breath test. RESULTS: Urea breath tests were requested on 249 patients; clinical notes and follow-up interview data were available for 207 patients (83%). The urea breath test was positive for 89 patients (43%); 70 were referred for endoscopy and peptic ulcer disease was found in 33 (47%). The urea breath test was negative for 118 patients; 14 were follow-up tests after previous H.pylori treatment. For the 104 patients with dyspepsia, a negative test and no previous treatment, 42% had 1 or more previous investigations for dyspepsia and 66% had dyspepsia symptoms for more than one year. During follow-up, 21 patients had endoscopy. Dyspepsia symptom scores were significantly lower at follow-up (p < 0.01). Using a global assessment, 66% had fewer symptoms, 22% same and 12% had more symptoms. The symptom improvement was greater if the duration of symptoms was less than one year (p < 0.05). Medication use did not change significantly. Twelve patients were dissatisfied with management; most of these would have preferred endoscopy. CONCLUSIONS: A negative urea breath test appears to have some reassurance value. The use of the urea breath test as initial assessment for dyspespia may prevent the need for some endoscopy. Further controlled studies of breath testing compared with early endoscopy are required.

Comparative assessment of chordal preservation versus chordal resection during mitral valve replacement.

Left ventricular function often deteriorates after mitral valve replacement for mitral regurgitation. It has been postulated that disruption of the mitral valve apparatus at operation is a major mechanism of postoperative dysfunction. The hypothesis tested in this investigation was that chordal preservation results in more favorable left ventricular function. Sixty-nine patients with isolated mitral regurgitation who underwent mitral valve replacement were studied before and 6 months after operation by treadmill exercise testing, catheterization, echocardiography, and radionuclide angiography. Nine patients underwent mitral valve replacement with preservation of the entire mitral apparatus and five with preservation of the posterior leaflet and attached chordae. The remaining 55 had mitral valve replacement with complete excision of the native valve. Preoperatively, there were no differences among groups in age, gender, exercise capacity, cardiac index, rest or exercise ejection fraction, fractional shortening, or pulmonary artery pressures. There were four perioperative deaths (7%) and eight late deaths among the 55 patients with chordal resection but no early or late deaths of patients whose chordae were preserved (p = 0.05). In patients in whom the chordae were excised, exercise capacity, left ventricular systolic dimensions, and cardiac index did not improve after mitral valve replacement, and left ventricular function deteriorated, as evidenced by a reduction of both the resting and exercise ejection fractions (from 46% +/- 13% to 31% +/- 13%, p = 0.0001, and from 49% +/- 12% to 37% +/- 14%, p = 0.0007, respectively) and fractional shortening (from 34% +/- 10% to 26% +/- 14%, p = 0.0001). In contrast, exercise capacity improved after mitral valve replacement in patients in whom the entire apparatus was spared (by 4 +/- 3 minutes, p = 0.05), left ventricular systolic dimensions decreased (from 44 +/- 8 to 36 +/- 9 mm, p = 0.03), and left ventricular function was maintained or improved, as evidenced by preservation of the resting ejection fraction (preoperative, 50% +/- 14%; postoperative, 54% +/- 11%; p = no significant difference), exercise ejection fraction (46% +/- 16% versus 52% +/- 9%, p = no significant difference), fractional shortening (from 31% +/- 9% to 28% +/- 9%, p = no significant difference), and an increase in the cardiac index (from 2.0 +/- 0.3 to 2.7 +/- 0.5 L/min/m2, p = 0.05). No statistically significant differences between posterior chordal resection only and preservation of the entire apparatus were found.(ABSTRACT TRUNCATED AT 250 WORDS)

Long-term hemodynamic assessment of the porcine heterograft in the mitral position. Late development of valvular stenosis.

We undertook a study of patients who had porcine mitral valves in place for more than 5 years and who had no clinical signs or symptoms suggestive of valve dysfunction. Of the first 54 patients who had porcine valves implanted in the mitral position, 18 were available for catheterization; all had a routine hemodynamic study postoperatively (mean 7 months) for comparison. Mean follow-up was 85 months (range 61-111 months). Compared with the early postoperative data, there was a significant increase in mean mitral valve gradient, from 5.9 +/- 0.7 to 8.6 +/- 0.7 mm Hg (p less than 0.01), and a significant decrease in calculated mitral valve area, from 2.2 +/- 0.2 to 1.7 +/- 0.2 cm2 (p less than 0.01). Moreover, seven patients showed a decrease in valve area greater than 1.0 cm2, five with valves in place for more than 80 months and only two of 11 patients with valves in place for 80 months or less (p less than 0.05). We conclude that there is a significant incidence of hemodynamic deterioration of porcine heterografts in the mitral position for greater than 5 years, even in patients who are clinically stable.

Assessment of hormone loss through hemofiltration.

The concentrations of testosterone, cortisone, gastrin, insulin, gastric inhibitory polypeptide (GIP), somatomedin B, parathyroid hormone (PTH), human growth hormone (HGH) and thyroid stimulating hormone (TSH) have been determined in the plasma and the ultrafiltrate of five uremic patients undergoing intermittent hemofiltration treatment. There was a considerable loss of gastrin, insulin, GIP, somatomedin B and PTH by hemofiltration treatment. The plasma concentrations, however, did not decrease except for immunoreactive-PTH (IR-PTH) which returned from elevated to normal levels. Cortisone, HGH and TSH concentrations in the ultrafiltrate were below the measureable range. A significant elimination of 11-hydroxylated androstans by hemofiltration may have a positive effect on the disturbed steroid metabolism. Results indicate that hemofiltration does not cause a hormone deficiency syndrome. On the contrary, the loss of degradation products of hormones with disturbing biological activity may be a favorable effect of the hemofiltration treatment.