Randomised clinical trial: Helicobacter pylori eradication is associated with a significantly increased body mass index in a placebo-controlled study.

BACKGROUND: Body mass index (BMI) increased following Helicobacter pylori eradication in several Japanese cohorts, which requires further investigation. AIM: To determine the impact of H. pylori eradication on BMI in a European population. METHODS: A total of 10,537 unselected people aged 20-59 years were screened for H. pylori; 1558 of the 1634 infected participants were randomised to intervention (eradication therapy: ranitidine bismuth citrate 400 mg and clarithromycin 500 mg twice daily) or placebo for 2 weeks with follow-up at 6 months (92%) for weight and dyspepsia symptoms (epigastric pain). RESULTS: The mean weight of participants in the intervention group increased from 77.7 kg at baseline to 78.4 kg at 6 months (unadjusted increase of 0.7 kg) and from 76.8 to 77.2 kg (0.5 kg) in the placebo group. The adjusted difference between randomised groups was statistically significant at 0.6 kg [95% confidence interval (CI) 0.31, 0.88]. Significantly, more participants gained ≥3 kg in the intervention group (138/720, 19%) compared with the placebo group (92/706, 13%) [odds ratio (OR) 1.57 (95% CI: 1.17, 2.12)]. The mean BMI increased from 27.5 to 27.8 kg/m(2) at 6 months in the intervention group compared with the increase from 27.0 to 27.2 kg/m(2) in the placebo group [adjusted difference between groups was statistically significant at 0.2 kg/m(2) (95% CI: 0.11, 0.31)]. Dyspepsia was less frequently reported by intervention group participants (168/736, 23%, placebo group 209/711, 29%), OR 0.71 (95% CI: 0.55, 0.93). CONCLUSION: Body mass index increased significantly following randomisation to H. pylori eradication therapy, possibly due to resolution of dyspepsia.

Clinical trial: prolonged beneficial effect of Helicobacter pylori eradication on dyspepsia consultations - the Bristol Helicobacter Project.

BACKGROUND: Chronic infection of the stomach with Helicobacter pylori is widespread throughout the world and is the major cause of peptic ulcer disease and gastric cancer. Short-term benefit results from community programmes to eradicate the infection, but there is little information on cumulative long-term benefit. AIM: To determine whether a community programme of screening for and eradication of H. pylori infection produces further benefit after an initial 2-year period, as judged by a reduction in GP consultations for dyspepsia. METHODS: A total of 1517 people aged 20-59 years, who were registered with seven general practices in Frenchay Health District, Bristol, had a positive (13)C-urea breath test for H. pylori infection and were entered into a randomized double-blind trial of H. pylori eradication therapy. After 2 years, we found a 35% reduction in GP consultations for dyspepsia (previously reported). In this extension to the study, we analysed dyspepsia consultations between two and 7 years after treatment. RESULTS: Between two and 7 years after treatment, 81/764 (10.6%) of participants randomized to receive active treatment consulted for dyspepsia, compared with 106/753 (14.1%) of those who received placebo, a 25% reduction, odds ratio 0.84 (0.71, 1.00), P = 0.042. CONCLUSIONS: Eradication of H. pylori infection in the community gives cumulative long-term benefit, with a continued reduction in the development of dyspepsia severe enough to require a consultation with a general practitioner up to at least 7 years. The cost savings resulting from this aspect of a community H. pylori eradication programme, in addition to the other theoretical benefits, make such programmes worthy of serious consideration, particularly in populations with a high prevalence of H. pylori infection.

Basiliximab (anti-CD25) in combination with steroids may be an effective new treatment for steroid-resistant ulcerative colitis.

BACKGROUND: Steroid resistance represents a major clinical problem in the treatment of ulcerative colitis. In vitro, interleukin-2 renders lymphocytes steroid resistant. AIM: To explore the therapeutic potential of interleukin-2 receptor blockade in steroid-resistant ulcerative colitis with both in vitro measures and a pilot in vivo study. METHODS: Ten patients with steroid-resistant ulcerative colitis received a single bolus of 40 mg of intravenous basiliximab plus steroid treatment in an open-label, uncontrolled, 24-week study. The outcome was assessed using the Ulcerative Colitis Symptom Score, rectal biopsy and Inflammatory Bowel Disease Questionnaire. Lymphocyte steroid sensitivity was measured in vitro in 39 subjects in the presence or absence of basiliximab. RESULTS: Nine of the 10 patients achieved clinical remission within 8 weeks. At 24 weeks, seven patients were in clinical remission. Marked improvement in the Ulcerative Colitis Symptom Score was seen by 1 week (P = 0.004) and on rectal biopsy and Inflammatory Bowel Disease Questionnaire by 2 weeks (both P < 0.05). Improvements persisted to 24 weeks (Ulcerative Colitis Symptom Score, Inflammatory Bowel Disease Questionnaire, both P < 0.005). Eight of the nine responders relapsed (median, 9 weeks), but remission was re-achieved with further corticosteroids and the addition of azathioprine. At 24 weeks, seven patients were in full clinical remission, five off all steroid therapy. In vitro measurement of lymphocyte steroid sensitivity demonstrated steroid resistance in 22% of subjects. All were rendered steroid sensitive in the presence of basiliximab. CONCLUSIONS: Basiliximab appears to be effective at inducing remission in steroid-resistant ulcerative colitis. In vitro, basiliximab also produced a dramatic increase in lymphocyte steroid sensitivity in healthy subjects. Confirmation in randomized controlled studies is required.

Relationship between the birth cohort pattern of Helicobacter pylori infection and the epidemiology of duodenal ulcer.

BACKGROUND: Helicobacter-pylori-related duodenal ulcer (DU) is an important cause of dyspepsia. AIM: To determine the relationship between the pattern of H. pylori infection and the epidemiology of duodenal ulcer in a single population. DESIGN: Prospective two-part study of (i) patients with DU referred for endoscopy because of dyspepsia, and (ii) the incidence of H. pylori infection in the general population of the same area. METHODS: Details of 533 DU patients were recorded, and related to the pattern of H. pylori infection among 10 537 adults in the same community, determined by the (13)C-urea breath test. RESULTS: In patients with DU, birth year was more important than age in determining the rate of presentation for endoscopy (the 'birth cohort' effect). H. pylori infection showed a similar birth cohort effect, and the prevalence decreased steadily in those born in successive years, from 28.8% in the 1930s to 3.5% in the 1970s. The proportion of dyspeptic patients who had duodenal ulcers also fell progressively, from 22.2% in 1979 to 5.7% in 1998. H. pylori prevalence and duodenal ulcer incidence were closely correlated at all ages. DISCUSSION: Duodenal ulcer prevalence (as judged by the rate of referral of duodenal ulcer patients for endoscopy) is determined principally by the distribution of H. pylori infection in the local population. The birth cohort effect seen in adult duodenal ulcer patients reflects the acquisition of H. pylori in childhood. In Bristol, H. pylori prevalence and duodenal ulcer incidence are both declining to very low levels.

Improving the diagnosis of coeliac disease in anaemic women.

The majority of patients with newly diagnosed coeliac disease have iron deficiency anaemia. Occult gluten enteropathy is common. We looked at blood donor volunteers, unable to donate because they were unexpectedly found to be anaemic, to determine the incidence of coeliac disease and whether this diagnosis is routinely considered. In a 4 month period, 110,973 blood donor volunteers were seen and 1% (1197 women and 183 men) were found to be anaemic. Of 483 anaemic samples selected for testing, 32 out of 483 were positive for IgA anti-endomysial antibodies. Microcytic anaemia was found in all but three of the 32 seropositive cases. Twenty-five out of 32 volunteers agreed to have endoscopic small bowel biopsies and 22 out of 25 (88%) had the typical histological appearances of coeliac disease. Twenty-one out of 22 cases were women. In no case prior to our intervention had these women been investigated for the possibility of coeliac disease. By selecting anaemic subjects for screening, there was an improved detection rate (over 6%) compared with non-anaemic volunteers (0%). There were far more anaemic women in the study population (ratio of anaemic women to anaemic men 5.5:1). We show that, especially in anaemic menstruating women, coeliac disease is unrecognized and under-investigated.

Risk factors for death and emergency transfer in acute and subacute inpatient rehabilitation.

OBJECTIVES: To compare the risk of death or emergency transfer (ET) to an acute care hospital for acute and subacute rehabilitation inpatients, to identify risk factors, and to determine whether the risk factors vary by level of care. DESIGN: Proportional hazards regression analysis of retrospective cohort data. Explanatory variables included level of care, age, sex, medical stability at admission, and diagnosis. SETTING: An acute inpatient rehabilitation hospital and a skilled nursing facility-based subacute rehabilitation program. PATIENTS: Patients were selected from a database of all acute and subacute inpatients discharged between January 1992 and August 1994 (N = 4,755). Readmissions and pediatric patients were excluded (n = 896). Patients who had complete data (n = 3,185) were included in the survival analysis; a separate univariable analysis was performed for patients who lacked complete data (n = 674). OUTCOME MEASURE: Rate of death or emergency transfer during rehabilitation. RESULTS: The overall risk was greater for subacute patients than for acute inpatients, 20.6% vs 11.6%, odds ratio = 2.0, CI = 1.6 to 2.5. The survival analysis indicated that age, level of care, sex, and stability were associated with the risk of death or emergency transfer (2.1 < or = zeta < or = 4.7; p < .05 for each). However, the difference in risk between subacute and acute care was greatest among younger patients. CONCLUSIONS: Careful consideration of risk factors is critical for proper assignment of patients to rehabilitation levels of care. However, research is needed to test these findings in other settings and to improve identification of high-risk patients.

Rehabits: a common language of functional assessment.

Probabilistic measurement models offered by Rasch and others can be used to link different functional assessment instruments into a single measurement system. This study assessed 54 subjects (diagnoses: 8 brain injuries, 7 neuromuscular, 22 musculoskeletal, 7 spinal cord, 10 stroke) admitted to a free-standing rehabilitation hospital at admission and discharge using both the Functional Independence Measure (FIM) and the Patient Evaluation and Conference System (PECS). Thirteen FIM and 22 PECS motor skills items were scaled together into a 35-item instrument, providing scale values for all items in the same unit of measurement. Separate FIM and PECS measures produced for each subject correlate .94 and .91 (p < .0001), respectively, with the cocalibration measures, and 0.91 (p < .0001) with each other. Either instrument's ratings are easily and quickly converted into the other's using the common unit of measurement, the rehabit (rehabilitation measuring unit). This article argues that the stability of the PECS and FIM item difficulty estimates over thousands of subjects, dozens of hospitals, hundreds of raters, and years of assessment is convincing evidence in support of the widespread use of their cocalibrated, common scale values as a functionometric ruler.

New developments in functional assessment: Probabilistic models for gold standards.

Advances in fundamental measurement have led to many exciting new developments in functional assessment. This paper presents fundamental measurement theory and method in summary form, and briefly describes its various applications to functional assessment, program evaluation, and outcomes analysis in physical medicine and rehabilitation. The implications of computerized medical records and longitudinal patient tracking in national or global computer networks for functional status and health status gold standards are briefly addressed.

Applying psychometric criteria to functional assessment in medical rehabilitation: III. Construct validity and predicting level of care.

A discriminant analysis was performed using Rasch ability estimates derived from four Patient Evaluation and Conference System (PECS) subscales, to distinguish among the functional independence and impairment profiles exhibited by patients admitted into any of three levels of medical rehabilitation delineated by the National Association of Rehabilitation Facilities (NARF): (1) inpatient hospital, (2) atypical nursing home (intermediate), or (3) day program. Two discriminant functions accounted for 91% and 9% of the between-group variance, respectively. Cross-validated classification of patients into one of the three levels of care, based on discriminant function scores, produced 75% correct classification; a 66% improvement over the percentage of correct classification likely by chance alone. Results support the construct validity of the PECS subscales and indicate they may be useful in validating clinically-based admission decisions among three of the levels of care promulgated by NARF.

The MD thesis in the training of a consultant physician.

A postal survey was carried out among the 94 consultant physicians of the South Western region (83% response rate) to ascertain their attitudes to the tradition of obtaining an MD by thesis as part of a physician's training. Most felt that the practice was questionable, and only half felt that it made an important contribution. For some, doing an MD had been a painful experience, even a waste of time. Having an MD impressed selection committees, but did not appear to alter the length of training nor the probability of obtaining a consultant post in a teaching hospital. We suggest that the MD is of limited value in judging a junior doctor's suitability to be a consultant physician.

Applying psychometric criteria to functional assessment in medical rehabilitation: II. Defining interval measures.

The use of functional assessment total scores in arithmetic operations has proliferated despite the lack of evidence supporting their use as interval measures of patient ability. Such evidence is minimally necessary to assure the validity of functional assessment total scores for clinical and management decision-making. Two requirements of interval measurement are explained and a set of Rasch analyses of 5,500 assessments using the Patient Evaluation and Conference System (PECS) are presented. The analyses were performed to determine the extent to which four item subsets identified in a previously reported factor analysis of the PECS comprise interval measures of functional independence status. Results indicate that the PECS scales meet these requirements to varying degrees. The analyses also identify areas in which measurement quality can be improved.

The diagnosis of intra-abdominal abscesses in patients with severe Crohn's disease.

A series of 24 patients with severe relapses of Crohn's disease responding poorly to conventional treatment with corticosteroids was studied to determine the incidence of intra-abdominal abscesses and the best means to detect them. Ultrasound scans proved to be difficult to interpret and unreliable. Computed tomography demonstrated abnormal bowel thickening in most cases, and showed seven of the eight intraabdominal abscesses. 111In leucocyte scintigraphy always demonstrated inflamed areas of bowel, but underestimated the extent of disease in three patients and overestimated it in five. All eight abdominal abscesses were detected, and there were no false-positive results. It was always possible to distinguish the abscess from inflamed bowel wall. Intra-abdominal abscess is not uncommon in patients with severe relapses of Crohn's disease which are not responsive to corticosteroid therapy, being present in about one-third of patients. 111In leucocyte scintigraphy is a simple and helpful test for differentiating between active inflammatory bowel disease and complicating abscesses, contributing significantly to the management of patients with severe Crohn's disease.

Obituary.

The announcement of the death in Bournemouth on February 18 1992 at the age of 82 years of Miss Muriel Hughes SRN, SCM, STD, lowers the curtain on a long and distinguished nursing career.

Applying psychometric criteria to functional assessment in medical rehabilitation: I. Exploring unidimensionality.

While rehabilitation providers are facing increasing pressure to document treatment outcomes, critics have warned against the inappropriate use of ordinal functional assessment data in arithmetic operations. Two salient criticisms concern the combination of items representing multidimensional abilities into a single total score, and the indeterminate distances between hierarchical functional assessment scale categories. In this initial study, the factor structure of the Patient Evaluation and Conference System (PECS) was studied to assess the potential for unidimensional measurement. Factor analysis of a multidiagnostic dataset (n = 3,564) yielded eight factors accounting for 60% of the variance among 68 PECS items. The factors indicate that several unidimensional measures may underlie the PECS. These factors are delineated, and further studies of unidimensionality and additivity are recommended.