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Patient acceptance of educational voice messages: a review of controlled clinical studies.

OBJECTIVES: The objective of this study was to evaluate controlled evidence on the impact of automated computer-based telephone messaging technology upon health outcomes, cost savings and acceptance by patients, caregivers and care providers. METHODS: Systematic searches of electronic databases were conducted to find controlled clinical studies of automated phone messaging used in patient care. Studies were selected based on the three criteria: 1) randomized controlled trials or controlled trials; 2) patients receiving health care related education, information, advice or reminder for a specific action to be taken in their home setting; and 3) use of automated computer-based phone technology to deliver the messages. Information abstracted from studies included information about the institution, persons targeted, intervention and its effect on health outcomes, costs and acceptance by patients and caregivers. RESULTS: A total of nineteen studies were identified for review. Sixteen studies were randomized controlled trials and three were controlled studies with no randomization. Studies were placed in two categories, preventive care education and chronic care studies. Preventive care education studies covered childhood immunizations, medication compliance, influenza vaccinations, tuberculosis and health prevention activities and chronic care studies were related to cholesterol, diabetes, hypertension and congestive heart failure. More than 80% of studies showed significant impact upon measurable health outcomes. CONCLUSIONS: Controlled evidence substantiates the efficacy of automated telephone communication in improving the quality of care. Educational voice messages are acceptable in patients and represent an important opportunity to enhance telemedicine and telehealth applications.

Automation↗

[Antibiotic treatment of travellers' diarrhea].

UNLABELLED: This review should be cited as: De Bruyn G, Hahn S, Borwick A. Antibiotic treatment for travellers' diarrhoea (Cochrane Review). In: The Cochrane Library, Issue 1, 2001. Oxford: Update Software. A substantive amendment to this systematic review was last made on 21 May 2000. Cochrane reviews are regularly checked and updated if necessary. BACKGROUND: Traveller's diarrhoea is a syndrome frequently encountered in persons crossing an international boundary. Diarrhoea can lead to significant discomfort and interference with travel plans. Bacterial pathogens are a frequent course of this syndrome. Several antibiotics have been tested for efficacy in reducing the duration and severity of the illness. OBJECTIVES: The aims of the review were to access the effects of antibiotics on traveller's diarrhoea in relation to the duration of illness, severity of illness, and adverse effects of medications. SEARCH STRATEGY: The Cochrane Collaboration Trials Register, MEDLINE, and EMBASE were searched. Additional trials were identified by hand searching. Content experts were contacted. SELECTION CRITERIA: All trials in any language in which travellers older than five years were randomly allocated to treatment for acute non-bloody diarrhoea with antibiotics and where the causative organism is not known at allocation. DATA COLLECTION AND ANALYSIS: Two reviewers assessed trial quality and extracted data. MAIN RESULTS: Twenty published studies met inclusion and quality criteria for inclusion. Twelve studies were placebo-controlled. A meta-analysis for the primary outcome was not feasible. All of the ten trials reported a significant reduction in duration of diarrhoea in participants treated with antibiotics compared with placebo. Data from two trials demonstrated a small reduction for antibiotic treated patients in the number of unformed stools passed per each 24 hour period from randomisation up to 72 hours. Data from six trials demonstrated a greater number of participants being cured of diarrhoea by 72 hours (odds ratio [OR] 5.9, 95% confidence interval [CI] 4.06 to 8.57). Data regarding side effects were available from five trials. There was wide variation in the prevalence of side effects reported in different trials. Persons taking antibiotics experienced more side effects than those taking placebo (OR 2.37, 95% CI 1.5 to 3.75). REVIEWERS' CONCLUSION: Antibiotic treatment is associated with shorter duration of diarrhoea but higher incidence of side effects. Trials generally do not report duration of post-treatment diarrhoea using time-to-event analyses, and should do.

Anti-Bacterial Agents↗

A randomized trial of sorbinil, an aldose reductase inhibitor, in diabetic retinopathy. Sorbinil Retinopathy Trial Research Group.

A total of 497 patients aged 18 to 56 years with insulin-dependent diabetes mellitus for 1 to 15 years were randomly assigned to take oral sorbinil or placebo and followed up for a median of 41 months. The percentage of patients whose retinopathy severity grade at maximum follow-up had worsened by two or more levels was not significantly different between the two treatment groups (28% in the sorbinil group and 32% in the placebo group, P = .344). The number of microaneurysms increased at a slightly slower rate in the sorbinil group than in the placebo group, with statistically significant differences at 21 (P = .046) and 30 (P = .039) months but not at the maximum follow-up (P = .156). About 7% of the patients assigned sorbinil developed a hypersensitivity reaction in the first 3 months. On the basis of these results, it is unlikely that sorbinil administered at a dosage of 250 mg daily for 3 years has a clinically important effect on the course of retinopathy in adults with insulin-dependent diabetes of moderate duration. Our data are consistent, however, with a slightly slower progression rate in the microaneurysm count among patients assigned to take sorbinil, a finding of uncertain clinical importance.

Adolescent↗

Diurnal blood pressure in patients with mild-to-moderate hypertension treated with once-daily benazepril hydrochloride.

This study evaluated the blood pressure effects of administration of once daily oral benazepril hydrochloride, a new angiotensin-converting enzyme (ACE) inhibitor, for mild-to-moderate hypertension. After a 2 to 4 week placebo baseline period, patients with diastolic blood pressure between 95 and 114 mm Hg, were randomized to receive either placebo or benazepril hydrochloride, 5, 10, 20, or 40 mg, once daily in double-blind fashion for 28 days. Blood pressure was measured predose and at 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours after the dose during inpatient observation days at the end of the placebo baseline period, and on the first and last day of the double-blind treatment period; and 24 hours after the dose at weekly outpatient visits. All doses of benazepril hydrochloride resulted in clinically important reductions in diastolic and systolic blood pressures that lasted between 12 and 24 hours after both the first dose, and following the last dose after 4 weeks of treatment. The findings indicate that benazepril hydrochloride may be clinically useful as once-daily monotherapy in many patients with hypertension.

Administration, Oral↗

[Conservative treatment of chronic sinusitis. Success of oral bacterial lysate therapy].

In a multicenter randomized double-blind study, 284 patients with chronic purulent sinusitis were treated with an oral immunostimulant or placebo in addition to standard therapy (antibiotics, mucolytics, inhalants). Treatment lasted for three ten-day periods in three consecutive months. At the start and during the therapy as well as after six months, symptoms were assessed on the basis of a scoring system and the X-rays of the nasal sinuses evaluated. During the course of therapy and the follow-up period, improvement of the major symptoms headache, purulent nasal discharge, cough, and expectoration was statistically significant in the immunostimulant group as compared with the placebo group, objective evidence being provided by the X-ray examinations and the number of reinfections during the period of observation.

Adjuvants, Immunologic↗

[Bite wounds and infection prophylaxis. Evidence-based therapeutic recommendations].

Infections are common complications of bite wounds, changing in severity from local cellulitis to life-threatening septicaemia. Treatment recommendations are often contradictory and rarely reflect evidence-based medicine. Risk factors associated with higher rates of infection include localization on the hands, puncture wounds and age older than 50 years. The literature is critically reviewed for evidence-based treatment of bite wounds. The results are discussed with respect to common practice in Denmark.

Age Factors↗

[Blockade of endothelin receptor with bosentan--a new principle of treatment in pulmonary arterial hypertension].

Blockade of endothelin receptors is a new drug principle for the treatment of pulmonary arterial hypertension. Bosentan is a competitive blocker of endothelin receptors administered by the oral route. In clinical trials it has been shown to increase the functional capacity of patients with pulmonary arterial hypertension. This article describes the background, results of clinical trials, and practical guidelines for the use of bosentan in pulmonary arterial hypertension.

Antihypertensive Agents↗

A comparison of the efficacy and safety of a beta-blocker, a calcium channel blocker, and a converting enzyme inhibitor in hypertensive blacks.

A double-blind, positively controlled, forced dose titration study comparing the efficacy and safety of atenolol, captopril, and verapamil sustained release as single agents in the treatment of black patients with mild to moderate hypertension (diastolic blood pressure, 95 to 114 mm Hg) was conducted. A total of 394 patients were randomized to one of the three therapies. Mean blood pressures during a 2- to 4-week placebo treatment period (baseline) ranged from 100.4 to 100.7 mm Hg diastolic and 151.7 to 152.5 mm Hg systolic for the three groups. Of the patients, 355 (of whom 345 had assessable data) completed the first treatment period, which consisted of therapy with either 50 mg/d of atenolol, 25 mg every 12 hours of captopril, or 240 mg/d of verapamil sustained release. During the second 4-week treatment period, which 319 patients completed (307 assessable), half of the patients had their antihypertensive medication increased and the other half continued the same dose. Goal blood pressure was defined as a supine diastolic pressure of less than 90 mm Hg or a 10-mm Hg or greater drop in supine diastolic blood pressure from pretreatment levels. Atenolol, captopril, and verapamil sustained release therapy was associated with goal blood pressure achievement during the first treatment period 55.1%, 43.8%, and 65.2% of the time, respectively, and during the second treatment period 59.6%, 57.1%, and 73.0% of the time. Side effects were minimal and comparable for all three drugs.

Adult↗

Recombinant human erythropoietin correction of anemia. Dialysis efficiency, waste retention, and chronic dose variables.

A clinical review of patients who were treated with recombinant human erythropoietin was undertaken to evaluate the effect of partial correction of anemia upon dialysis function and waste retention. Assessment of possible variables that might influence the dosage response was also undertaken, both in a retrospective and prospective manner. Finally, a chart review of patients' symptoms while on dialysis was done to evaluate the effect of correction of anemia. Hematologic improvement was noted in all patients placed on hormone therapy with the correction of hemoglobin and hematocrit. There was no effect on white cell count, although a slight change in the differential was noted at target and one year; platelets rose to a new steady state. Dialysis efficiency was decreased slightly for urea and markedly for creatinine, probable reflecting the distribution characteristics of the latter. Retention of urate, phosphorus, and potassium was noted at target, with a drop toward usual serum levels with minimal dialysis prescription change. Variables such as age, gender, race, and dialysis prescription were compared in an effort to establish dosage variation, but no statistically significant changes were seen. There was an inverse trend in dosage, however, with increasing dialysis efficiency. Patients also seemed to be more tolerant of their dialysis treatments when nonanemic, compared to when anemic. While there is retention of some substances with improvement of anemia, the levels were easily corrected with adjustment of the dialysis prescription. No definite relationship could be seen in any of the variables studied and hormone dose requirements. Attention must be paid to adequate dialysis prescription in the erythropoietin treated patient.

Anemia↗

Clinical studies in surgical journals--have we improved?

A critical appraisal of all clinical studies published in 1980 and 1990 in three surgical journals--Diseases of the Colon and Rectum (DCR), Surgery (SURG), and the British Journal of Surgery (BJS)--was made to ascertain the frequency with which various research designs appeared, the standard of individual clinical studies, and a comparison of changes in the past decade. Clinical studies were classified into case studies or comparative studies. Comparative studies included randomized controlled trials (RCT), nonrandomized controlled trials, retrospective cohorts, and case-control studies. A 10-point index score (range, 0-10) was used to assess the comparative studies. A sample of articles was analyzed for interobserver and intraobserver variation, with strong agreement between reviewers for classification of trials (unweighted kappa, 0.87) and index scores (0.67). Of 1,481 articles reviewed, 1,060 were classified as clinical studies. Sixteen percent of all clinical studies were comparative studies in 1980, compared with 17 percent in 1990. Of these, 7 percent were RCT in both years. In 1980, 6 percent of clinical studies in DCR were comparative studies, 19 percent in BJS, and 18 percent in SURG. In 1990, 11 percent, 18 percent, and 18 percent, respectively, were comparative studies. In 1980, the proportion of RCT in DCR was 0 percent, in BJS 12 percent, and in SURG 4 percent, compared with 3 percent, 8 percent, and 8 percent, respectively, in 1990. Overall, 52 of 76 (68 percent) RCT were published in BJS. The standard of comparative studies increased overall from 5.49 to 6.04 (P = NS), and that of RCT increased from 7.06 to 7.70 (P = NS). The standard of comparative studies in DCR in 1980 was lower than those in BJS (P < 0.001) and SURG (P < 0.001). The standard of comparative studies in DCR improved from 1.67 in 1980 to 5.47 in 1990 (P < 0.001). There was no significant difference in the standard of comparative studies among the three journals in 1990. In conclusion, there has been no overall increase in the proportion of stronger clinical trial designs in the journals reviewed. A small increase seen in the overall standard of comparative studies was not statistically significant.

Case-Control Studies↗

Group based training for self-management strategies in people with type 2 diabetes mellitus.

BACKGROUND: It has been recognised that adoption of self-management skills by the person with diabetes is necessary in order to manage their diabetes. However, the most effective method for delivering education and teaching self-management skills is unclear. OBJECTIVES: To assess the effects of group-based, patient-centred training on clinical, lifestyle and psychosocial outcomes in people with type 2 diabetes. SEARCH STRATEGY: Studies were obtained from computerised searches of multiple electronic bibliographic databases, supplemented by hand searches of reference lists of articles, conference proceedings and consultation with experts in the field. Date of last search was February 2003. SELECTION CRITERIA: Randomised controlled and controlled clinical trials which evaluated group-based education programmes for adults with type 2 diabetes compared with routine treatment, waiting list control or no intervention. Studies were only included if the length of follow-up was six months or more and the intervention was at least one session with the minimum of six participants. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. A meta-analysis was performed if there were enough homogeneous studies reporting an outcome at either four to six months, 12-14 months, or two years, otherwise the studies were summarised in a descriptive manner. MAIN RESULTS: Fourteen publications describing 11 studies were included involving 1532 participants. The results of the meta-analyses in favour of group-based diabetes education programmes were reduced glycated haemoglobin at four to six months (1.4%; 95% confidence interval (CI) 0.8 to 1.9; P < 0.00001), at 12-14 months (0.8%; 95% CI 0.7 to 1.0; P < 0.00001) and two years (1.0%; 95% CI 0.5 to 1.4; P < 0.00001); reduced fasting blood glucose levels at 12 months (1.2 mmol/L; 95% CI 0.7 to 1.6; P < 0.00001); reduced body weight at 12-14 months (1.6 Kg; 95% CI 0.3 to 3.0; P = 0.02); improved diabetes knowledge at 12-14 months (SMD 1.0; 95% CI 0.7 to 1.2; P < 0.00001) and reduced systolic blood pressure at four to six months (5 mmHg: 95% CI 1 to 10; P = 0.01). There was also a reduced need for diabetes medication (odds ratio 11.8, 95% CI 5.2 to 26.9; P < 0.00001; RD = 0.2; NNT = 5). Therefore, for every five patients attending a group-based education programme we could expect one patient to reduce diabetes medication. AUTHORS' CONCLUSIONS: Group-based training for self-management strategies in people with type 2 diabetes is effective by improving fasting blood glucose levels, glycated haemoglobin and diabetes knowledge and reducing systolic blood pressure levels, body weight and the requirement for diabetes medication.

Adult↗

Spironolactone and altizide used in combination with enalapril: twenty-four-hour ambulatory recording of blood pressure.

The addition of enalapril or acebutolol to a regimen of altizide + spironolactone in patients with moderate hypotension was investigated in a multicenter study of 53 patients. The patients underwent semiambulatory 24-hour blood pressure monitoring, especially to observe hypotensive episodes. In the 25 patients uncontrolled with altizide + spironolactone alone, enalapril and acebutolol were about equally effective in reducing blood pressure. The incidence of hypotension was low and comparable for both treatment groups, provided that the initial dose of angiotensin-converting enzyme inhibitor was low (5 mg).

Acebutolol↗