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Results for “Randomized controlled trials”

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PubMed2003

Effectiveness and cost of olanzapine and haloperidol in the treatment of schizophrenia: a randomized controlled trial.

CONTEXT: Although olanzapine has been widely adopted as a treatment of choice for schizophrenia, its long-term effectiveness and costs have not been evaluated in a controlled trial in comparison with a standard antipsychotic drug. OBJECTIVE: To evaluate the effectiveness and cost impact of olanzapine compared with haloperidol in the treatment of schizophrenia. DESIGN AND SETTING: Double-blind, randomized controlled trial with randomization conducted between June 1998 and June 2000 at 17 US Department of Veterans Affairs medical centers. PARTICIPANTS: Three hundred nine patients with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of schizophrenia or schizoaffective disorder, serious symptoms, and serious dysfunction for the previous 2 years. Fifty-nine percent fully completed and 36% partially completed follow-up assessments. INTERVENTIONS: Patients were randomly assigned to receive flexibly dosed olanzapine, 5 to 20 mg/d, with prophylactic benztropine, 1 to 4 mg/d (n = 159); or haloperidol, 5 to 20 mg/d (n = 150), for 12 months. MAIN OUTCOME MEASURES: Standardized measures of symptoms, quality of life, neurocognitive status, and adverse effects of medication. Veterans Affairs administrative data and interviews concerning non-VA service use were used to estimate costs from the perspective of the VA health care system and society as a whole (ie, consumption of all resources on behalf of these patients). RESULTS: There were no significant differences between groups in study retention; positive, negative, or total symptoms of schizophrenia; quality of life; or extrapyramidal symptoms. Olanzapine was associated with reduced akathisia in the intention-to-treat analysis (P<.001) and with lower symptoms of tardive dyskinesia in a secondary analysis including only observations during blinded treatment with study drug. Small but significant advantages were also observed on measures of memory and motor function. Olanzapine was also associated with more frequent reports of weight gain and significantly greater VA costs, ranging from 3000 dollars to 9000 dollars annually. Differences in societal costs were somewhat smaller and were not significant. CONCLUSION: Olanzapine does not demonstrate advantages compared with haloperidol (in combination with prophylactic benztropine) in compliance, symptoms, extrapyramidal symptoms, or overall quality of life, and its benefits in reducing akathisia and improving cognition must be balanced with the problems of weight gain and higher cost.

Adult↗

PubMed1997

Effects of a low-fat high-carbohydrate diet on plasma sex hormones in premenopausal women: results from a randomized controlled trial. Canadian Diet and Breast Cancer Prevention Study Group.

We are conducting a long-term randomized controlled trial to determine if intervention with a low-fat high-carbohydrate diet reduces breast cancer risk. The present study examines the effects of 2 years of dietary intervention on serum sex hormone levels in premenopausal women. Subjects with extensive mammographic densities were enrolled in a dietary intervention trial. The intervention involved intensive individual counselling aimed at reducing total dietary fat to 15% of calories. Control subjects received general advice about diet but were not counselled to change their fat intake. Serum sex hormone levels were measured in 220 premenopausal subjects at entry and 2 years after randomization. Two years after randomization oestradiol levels were 20% (70 pmol l(-1)) lower (P = 0.04) and progesterone levels were 35% (1.0 nmol l(-1)) lower (P = 0.004) and follicle-stimulating hormone (FSH) levels were 7% (1 IU) higher (P = 0.38) in the intervention group than in the control group. The FSH-oestradiol ratio was 13% higher in the intervention group (P = 0.18). Samples analysed accounting for the timing of the blood sample in relation to the menstrual cycle showed that, in the intervention group, oestradiol and progesterone levels were lower and FSH levels higher in subjects with blood samples taken more than 30 days after the last menstrual period. Because of the strong evidence linking ovarian hormonal activity to breast cancer risk, these results suggest that a low-fat high-carbohydrate diet may reduce risk of breast cancer by reducing exposure to ovarian hormones that are a stimulus to cell division in the breast.

Adult↗

PubMed1992

Results of a randomized controlled trial of carotid endarterectomy for asymptomatic carotid stenosis. Mayo Asymptomatic Carotid Endarterectomy Study Group.

We undertook a randomized controlled trial designed to compare the effects of carotid endarterectomy with medical treatment using low-dose aspirin in patients with asymptomatic carotid stenosis. During 30 months of recruitment, 71 randomized and 87 eligible nonrandomized patients participated in a follow-up protocol. The total ipsilateral perioperative stroke and death rate was 0% among randomized patients and 3% among nonrandomized patients, and the major stroke and death rate was 0% for both groups. Too few cerebral ischemic events occurred to judge the comparative effectiveness of carotid endarterectomy versus low-dose aspirin for asymptomatic carotid stenosis. The trial was terminated early because of a significantly higher number of myocardial infarctions and transient cerebral ischemic events in the surgical group than in the medical group. Most of the events were not temporally related to the surgical procedure, but there was evidence that these events could have related to the absence of aspirin use in the surgical group. These observations reinforce the appropriateness of the use of aspirin throughout the perioperative period and beyond (unless contraindications exist) in patients with asymptomatic carotid stenosis who undergo carotid endarterectomy.

Aged↗

PubMed2005

Effects of a lifestyle programme on ambulatory blood pressure and drug dosage in treated hypertensive patients: a randomized controlled trial.

OBJECTIVE: To assess effects of multifactorial lifestyle modification on antihypertensive drug needs in treated hypertensive individuals. DESIGN: Randomized controlled trial. SETTING: Research studies unit. PARTICIPANTS: Overweight hypertensive patients, receiving one or two antihypertensive drugs, were recruited by advertising, and allocated randomly to a usual care group (controls; n = 118) or a lifestyle modification group (programme group; n = 123). INTERVENTION: A 4-month programme of weight loss, a low-sodium 'Dietary Approaches to Stop Hypertension'-type diet with added fish, physical activity and moderation of alcohol intake. After 4 months, if mean 24-h ambulatory blood pressure (ABP) was less than 135/85 mmHg, antihypertensive drugs were withdrawn over 4 weeks and long-term home blood pressure monitoring was begun. MAIN OUTCOME MEASURES: Antihypertensive drug requirements, ABP, weight, waist girth at 4 months and 1-year follow-up. RESULTS: Ninety control group and 102 programme group participants completed the study. Mean 24-h ABP changed after 4 months by -1.0/-0.3 +/- 0.5/0.4 mmHg in controls and -4.1/-2.1 +/- 0.7/0.5 mmHg with the lifestyle programme (P < 0.01). At follow-up, changes in the two groups were not significantly different (4.1/1.3 +/- 1.1/1.0 mmHg in controls; 2.5/-0.1 +/- 1.1/0.8 mmHg in the programme group; P = 0.73). At 4 months, drug withdrawal differed significantly between the groups (P = 0.038) in men (control 44%; programme 66%) but not in women (65 and 64%, respectively; P = 0.964). At follow-up, sex-related differences were not significant, and 41% in the control group and 43% in the programme group maintained drug-withdrawal status. With the programme, net weight loss was 3.3 kg (P < 0.001) at 4 months and 3.0 kg (P < 0.001) at follow-up; respective net decreases in waist girth were 3.3 cm (P < 0.001) and 3.5 cm (P < 0.001). CONCLUSIONS: A 4-month multifactorial lifestyle modification in patients with treated hypertension reduced blood pressure in the short-term. Decreased central obesity persisted 1 year later and could reduce overall cardiovascular risk.

Antihypertensive Agents↗

PubMed1982

Effects of prenatal nutritional supplementation on the placenta: report of a randomized controlled trial.

Protein and nucleic acid content, and RNase levels were measured in placentas collected at birth in a randomized controlled trial of prenatal nutritional supplementation in New York City. These biochemical indices were explored to understand better the effects of nutritional supplementation. (With high-protein supplements, gross measures had shown no improvement in outcome at birth and adverse effects on fetal growth, prematurity, and newborn survival; with balanced protein-calorie supplements, there was a nonsignificant rise in birth weight and longer gestation.) The biochemical indices were in general somewhat weakly related to fetal growth measures. Significant effects of nutritional treatment on the indices were minimal, and added no information that could account for gross effects observed in the fetus.

Birth Weight↗

PubMed1981

Randomized controlled trial of vasodilator therapy after myocardial infarction.

Hemodynamic changes and mortality and morbidity were compared in a randomized controlled trial of sodium nitroprusside after acute myocardial infarction. Fifty patients with a mean pulmonary capillary wedge pressure of more than 20 mm Hg within 24 hours of acute infarction were randomly assigned to one of two groups: 25 patients treated with nitroprusside and 25 treated with furosemide. Nitroprusside rapidly produced a sustained decrease in systemic vascular resistance and increase in cardiac index (thermodilution). After 1 hour the cardiac index had increased 16 +/- 3 (mean +/- standard error of the mean) percent (p less than 0.001) compared with a decrease of 7 +/- 3 percent with administration of furosemide (p less than 0.01). Differences in systemic vascular resistance and cardiac index in the two groups persisted throughout the 48 hour treatment period (p less than 0.001). Pulmonary capillary wedge pressure decreased rapidly with nitroprusside and slowly with furosemide so that, although it was significantly lower in the former group overall (p less than 0.001), by 48 hours the values were not different. Although beneficial acute hemodynamic effects of nitroprusside were demonstrated, there was no difference in mortality or in morbidity assessed clinically, by chest X-ray film, echocardiogram or graded treadmill stress testing after 6 months or 1 year.

Acute Disease↗

PubMed1992

Preventing hypoxemia during colonoscopy. A randomized controlled trial of supplemental oxygen.

Hypoxia as measured by pulse oximetry is well recognized in patients undergoing colonoscopy. A single trial of supplemental oxygen therapy has been shown to diminish the observed desaturation during colonoscopy. We further defined the role of supplemental oxygen during colonoscopy in a randomized controlled trial. Ninety-four patients undergoing routine colonoscopy were randomized to oxygen (2 L by nasal prongs) or placebo (nasal prongs only) arms. The physician and patients were blinded to which arm they were in. Sixty-four percent of patients in the placebo arm desaturated (less than 90% saturation) versus 29% in the treatment arm (p less than 0.001). There were no complications observed in either arm. We conclude that supplemental oxygen will decrease but not prevent the incidence of arterial desaturation observed during colonoscopy.

Aged↗

PubMed2000

Routine ultrasound fetal examination in pregnancy: the 'Alesund' randomized controlled trial.

OBJECTIVE: To evaluate the possible benefits of the routine use of ultrasound screening in pregnancy. DESIGN: A randomized controlled trial was designed to detect a 50% difference in the incidence of induction for apparent post-term pregnancies between women who were screened with ultrasound and unscreened women. A total of 1628 pregnant women from the general population were included. Eight hundred and twenty-five were allocated to an ultrasound examination at the 18th and 32nd week of pregnancy in addition to receiving routine antenatal care. The remaining 803 women received standard antenatal care, but could only be referred for ultrasound examination on clinical indication. RESULTS: The incidence of induced labor due to apparent post-term pregnancies was approximately 70% lower in the ultrasound-screened group. Inductions from all causes were also less frequent among ultrasound-screened women. There were six perinatal deaths among the screened and seven among the controls after excluding three lethal malformations among the controls. There was no difference in Apgar score after 1 min, but the proportion with Apgar score less than 8 after 5 min was lower among the screened group (P = 0.04). The need for positive pressure ventilation for more than 1 min was lower among the screened group (P = 0.02). Birth weight was slightly higher in the screened group (39 g), but the difference was not statistically significant. Among the controls three pairs of twins remained undiagnosed until the mothers were admitted to the hospital in labor at between 36 and 38 weeks gestation. CONCLUSION: These results suggest that for women who were screened with ultrasound, obstetricians were less likely to induce labor due to apparent post-term pregnancy, than for women who were not screened. All 10 pairs of twins in the screened group were diagnosed at the routine examination. These data also suggest that perinatal morbidity might be slightly lower in the screened group.

Adult↗

PubMed2026

'Sawa Aqwa' (Stronger Together): A multi-site randomized controlled trial of a brief family systemic intervention for adolescent mental health in Lebanon.

BACKGROUND: There are no evaluated family-based mental health and psychosocial support (MHPSS) interventions for adolescents in Southwest Asia (known as the Middle East), and few whole-family interventions in low- and middle-income countries, despite consistent evidence for the impact of family support on mental health and well-being. This study aims to evaluate the effectiveness of a brief family systemic mental health intervention, deliverable by non-specialists in mental health. METHODS: We conducted an assessor-blind type I hybrid effectiveness-implementation multi-site randomized controlled trial comparing the locally developed family intervention to a waitlist control group for randomly allocated families residing in North Lebanon and Beqa'a governorates. Eligible families presented with medium-to-high risk for child protection concerns (abuse, neglect, child labor, early marriage) and had at least one adolescent aged 12-17 who demonstrated psychological distress. Outcomes at the family, caregiver, and adolescent level were measured pre- and post-intervention, and at 3-month follow-up. RESULTS: Intent-to-treat analyses found a significant between-group effect of the intervention on adolescent-reported family functioning, caregiver mental health, and parenting. No change was found for adolescent psychological distress. Further analyses found effects on adolescent well-being for those who completed the intervention, and that father attendance was associated with better outcomes for adolescent well-being in the intervention group. No other significant moderators were found. At the 3-month follow-up for the intervention condition, family functioning and caregiver well-being significantly dropped from endline. CONCLUSIONS: The study demonstrates mixed results for a non-specialist-delivered family-systemic intervention developed in the context of humanitarian crises in Lebanon. While the intervention did not result in benefits in adolescent-reported symptoms of psychological distress, the intervention group did show greater improvements than the control group on a number of other outcomes, showing the potential impact of working with the wider family system to support adolescents in humanitarian settings.

Humans↗

PubMed1983

Randomized controlled trials in hospital epidemiology. Sixth annual National Foundation for Infectious Diseases lecture.

Randomized controlled trials (RCTs) are useful in the evaluation of both new and well-established hospital infection control practices for which the benefit is unproven and not obvious. RCTs are often undertaken to resolve controversies, and many of them have a "negative" or inconclusive outcome. Well-designed RCTs with a negative outcome have the potential for reducing health care costs by identifying widely used preventive measures that are not cost effective. ICPs should appreciate that RCTs have important limitations, may contain serious flaws in design, and are subject to exploitation by pharmaceutical and equipment manufacturers. Knowledge of the principles of RCTs can lead to improved scientific standards for all research--nonrandomized as well as randomized--in hospital epidemiology.

Clinical Trials as Topic↗

PubMed2001

Beyond randomized controlled trials: organized mammographic screening substantially reduces breast carcinoma mortality.

BACKGROUND: The efficacy of mammographic screening in the reduction of breast carcinoma mortality has been demonstrated in randomized controlled trials. However, the evaluation of organized screening outside of research settings (so-called "service screening") faces unique methodologic and conceptual challenges. The current study describes the evaluation of organized mammography screening in a clinical setting and demonstrates the benefit obtained from service screening in two Swedish counties. METHODS: In the group of subjects ages 20--69 years, there were 6807 women diagnosed with breast carcinoma over a 29-year period in 2 counties in Sweden and 1863 breast carcinoma deaths. All patients were classified from patient charts based on their screening status (i.e., whether they had been invited to undergo screening and whether they actually had undergone screening). The number of women who lived in the 2 counties during the 29-year study period was provided by the Central Bureau of Statistics. Breast carcinoma-specific mortality was compared across three time periods: 1) 1968--1977, when no screening was taking place because mammography had not been introduced; 2) 1978--1987, the approximate period of the Two-County randomized controlled trial of screening in women ages 40--74 years; and 3) 1988--1996, when all women in the 2 counties ages 40--69 years were invited to undergo screening (service screening). When comparing breast carcinoma mortality in screened women with that in women diagnosed before screening was introduced, a correction for self-selection bias was incorporated to prevent overestimation of the benefit of screening. RESULTS: The mortality from incident breast carcinoma diagnosed in women ages 40-69 years who actually were screened during the service screening period (1988--1996) declined significantly by 63% (relative risk [RR] = 0.37; 95% CI, 0.30--0.46) compared with breast carcinoma mortality during the time period when no screening was available (1968--1977). The mortality decline was 50% (RR = 0.50; 95% CI, 0.41--0.60) when breast carcinoma mortality among all women who were invited to undergo screening (nonattendees included) was compared with breast cancer mortality during the time period when no screening was available (1968--1977). The reduction in mortality observed during the service screening period, adjusted for selection bias, was 48% (RR = 0.52; 95% CI, 0.43--0.63). No significant change in breast carcinoma mortality was observed over the three time periods in women who did not undergo screening. This group included women ages 20--39 years because these individuals were never invited to undergo screening, and women ages 40--69 years who did not undergo screening (not invited during the randomized trial or invited during the second and third time periods but declined). CONCLUSIONS: Regular mammographic screening resulted in a 63% reduction in breast carcinoma death among women who actually underwent screening. The policy of invitation to organized screening with mammography appears to have reduced breast carcinoma mortality by 50% in these 2 counties.

Adult↗

PubMed2001

Primary care for patients infected with human immunodeficiency virus: a randomized controlled trial.

OBJECTIVE: To measure the impact of a teaching intervention and to compare process and outcomes of care for HIV-infected patients randomly assigned to a general medicine clinic (GMC) or an infectious disease clinic (IDC) for primary care. DESIGN: Prospective, randomized, controlled trial. SETTING: University hospital in Durham, NC. PATIENTS: Two hundred fourteen consecutive HIV-infected patients presenting for primary care. INTERVENTION: Physicians at the GMC received HIV-related training and evidence-based practice guidelines. MEASUREMENTS: Utilization of services, health-related quality of life, preventive and screening measures, and antiretroviral use for one year. RESULTS: At baseline GMC patients were more likely to be African American (85% vs 71%; P =.03) and had lower baseline CD4+ cell counts than IDC patients (262 +/- 269 vs 329 +/- 275; P =.05). A similar and high proportion of patients in both groups received appropriate preventive care services including Pneumocystis carinii pneumonia (PCP) prophylaxis, pneumococcal vaccination, and antiretroviral therapy. Screening for TB was more frequent in GMC (89% vs 68%; P =.001). In the year following randomization, GMC patients made more visits to the emergency department than IDC patients (1.6 +/- 3.0 vs 0.7 +/- 1.5; P =.05). Hospital use was higher for GMC patients with average length of stay 7.8 +/- 6.3 days compared to 5.7 +/- 3.8 days for IDC patients (P =.01). In analyses, which adjust for potential baseline imbalances, these differences remained. CONCLUSIONS: Targeted education in GMC achieved similar provision of primary care for GMC patients, yet use of health care services was higher for this group. The delivery of adequate primary care is necessary but not sufficient to produce changes in health care utilization.

Continuity of Patient Care↗

PubMed2000

Prophylactic amnioinfusion for intrapartum oligohydramnios: a meta-analysis of randomized controlled trials.

OBJECTIVE: To evaluate the effectiveness of intrapartum prophylactic amnioinfusion in pregnancies complicated by oligohydramnios. DATA SOURCES: Randomized controlled trials of prophylactic amnioinfusion in women with oligohydramnios were identified using computerized databases, index reviews, and references cited in original studies and review articles. METHODS OF STUDY SELECTION: We evaluated, abstracted data from, and analyzed randomized studies of prophylactic intrapartum amnioinfusion in women with oligohydramnios. In every study the group allocation was based exclusively on presence of oligohydramnios. Only published studies with clearly documented outcome data were included. The quality of each trial was evaluated for methodology, inclusion and exclusion criteria, adequacy of randomization, amnioinfusion protocols, definition of outcomes, and statistical analyses. The trials were evaluated concerning cesarean deliveries for fetal heart rate (FHR) abnormalities, overall cesarean rates, acidemia at birth, intrapartum fetal heart rate abnormalities, Apgar scores under 7 at 5 minutes, and postpartum endometritis. TABULATION, INTEGRATION, AND RESULTS: Thirty-five studies were identified, of which 14 met the inclusion criteria for this systematic review. They included 1533 patients, 793 in the amnioinfusion group, and 740 controls. Odds ratios (OR) with their 95% confidence intervals (CI) for each outcome were calculated. We calculated an estimate of the OR and risk difference for dichotomous outcomes using random and fixed-effects models. A test of homogeneity was done across studies. Women with oligohydramnios who received intrapartum amnioinfusion had lower incidence of cesarean for FHR abnormalities (OR 0.23; 95% CI 0.15, 0.35). Intrapartum amnioinfusion also was associated with lower overall rates of cesarean deliveries (OR 0.52; 95% CI 0.40, 0. 68), acidemia at birth (OR 0.40; 95% CI 0.30, 0.55), FHR abnormalities during labor (OR 0.24; 95% CI 0.17, 0.34), and Apgar scores under 7 at 5 minutes (OR 0.52; 95% CI 0.29, 0.91). Postpartum endometritis rates were similar among the study groups. CONCLUSION: In the presence of oligohydramnios, prophylactic intrapartum amnioinfusion significantly improves neonatal outcome and lessens the rate of cesarean delivery, without increasing the rate of postpartum endometritis.

Amniotic Fluid↗

PubMedDate not supplied

A randomized controlled trial of the effectiveness of exercise and/or alternating air mattress in the control of back pain after percutaneous transluminal coronary angioplasty.

OBJECTIVE: To determine whether an alternating air mattress, a specifically designed exercise program, or both were effective in alleviating back pain in patients after percutaneous transluminal coronary angioplasty (PTCA). DESIGN: 2 by 2 factorial, randomized control trial. SETTING: Intermediate cardiac care unit in a Canadian regional cardiac referral center. SUBJECTS: The sample included 100 subjects, X age 57.4 years, undergoing PTCA. INSTRUMENTS: 10 cm visual analog and Borg scales, both of which measured subjects' perception of pain. RESULTS: The combination of exercise and alternating air mattress is most effective in pain reduction (p = 0.012). CONCLUSION: The combination of exercise and alternating air mattress is more effective in alleviating back pain in patients after PTCA than conventional methods or exercise and alternating air mattress alone.

Adult↗

PubMed2005

A randomized controlled trial on the efficacy of exercise for patients with chronic neck pain.

STUDY DESIGN: A randomized controlled trial with single-blind outcome assessments. OBJECTIVE: To evaluate the efficacy of a neck exercise program in patients with chronic neck pain. SUMMARY OF BACKGROUND DATA: The effect of exercise for patients with chronic neck pain has been investigated in a number of studies. The efficacy is, however, questionable. METHODS: A total of 145 patients were randomly allocated into an exercise (n = 67) and a nonexercise (control) group (n = 78). Patients in the control group were given infrared irradiation and neck care advice. In addition to infrared irradiation and advice, patients in the exercise group had undergone an exercise program with activation of the deep neck muscles and dynamic strengthening of the neck muscles for 6 weeks. Subjective pain and disability and isometric neck muscle strength were measured at baseline, 6 weeks, and 6 months. Analysis was by intention-to-treat. RESULTS: At week 6, the exercise group had a significantly better improvement in disability score (P = 0.03), subjective report of pain (P = 0.01), and in isometric neck muscle strength (P = 0.57-0.00) in most of the directions than the control group. However, significant differences between the two groups were found only in the subjective report of pain and patient satisfaction at the 6-month follow-up. CONCLUSIONS: At week 6, patients with chronic neck pain can benefit from the neck exercise program with significant improvement in disability, pain, and isometric neck muscle strength in different directions. However, the effect of exercise was less favorable at 6 months.

Adult↗

PubMed2004

Physicians' choice in using Internet and fax for patient recruitment and follow-up in a randomized controlled trial.

OBJECTIVE: To examine the physicians' preference between Web and fax-based remote data entry (RDE) system for an ongoing randomized controlled trial (RCT) in Japan. METHODS: We conducted a survey among all the collaborating physicians (n = 512) of the CASE-J (Candesartan Antihypertensive Survival Evaluation in Japan) trial, who have been recruiting patients and sending follow-up data using the Web or a fax-based RDE system. The survey instrument assessed physicians' choice between Web and fax-based RDE systems, their practice pattern, and attitudes towards these two modalities. RESULTS: A total of 448 (87.5%) responses were received. The proportions of physicians who used Web, fax, and the combination of these two were 45.9%, 33.3% and 20.8%, respectively. Multivariate logistic regression analyses revealed that physicians 55 years or younger [odds ratio (OR) = 1.9, 95% confidence interval (CI) = 1.1-3.3] and regular users of computers (OR = 4.2, 95% CI = 2.1-8.2) were more likely to use the Web-based RDE system. CONCLUSIONS: This information would be useful in designing an RCT with a Web-based RDE system in Japan and abroad.

Adult↗

PubMed2002

Primary care guidelines on consultation practices: the effectiveness of computerized versus paper-based versions. A cluster randomized controlled trial among newly qualified primary care physicians.

OBJECTIVE: To compare the effects of computerized and paper-based versions of guidelines on recently qualified physicians' consultation practices. METHODS: Two arm cluster randomized controlled trial. Physicians were randomized to receive computerized or textbook-based versions of the same guidelines for a 4-week study period. Physicians' compliance with guideline recommendations about laboratory, radiological, physical and other examinations, procedures, nonpharmacologic and pharmacologic treatments, physiotherapy, and referrals were measured by case note review. RESULTS: There were 139 recently qualified physicians working in 96 primary healthcare centers in Finland who participated in the study. Data on 4,633 patient encounters were abstracted, of which 3,484 were suitable for further analysis. Physicians' compliance with guidelines was high (over 80% for use of laboratory, radiology, physical examinations, and referrals). There were no significant differences in physicians' consultation practices in any of the measured outcomes between the computerized and textbook group. CONCLUSION: Guidelines are a useful source of information for recently qualified physicians working in primary care. However, the method of presentation of the guidelines (electronic or paper) does not have an effect on guideline use or their impact on decisions. Other factors should be considered when choosing the method of presentation of guidelines, such as information-seeking time, ease of use during the consultation, ability to update, production costs, and the physician's own preferences.

Cluster Analysis↗

PubMed2005

Staff training and ambulatory tuberculosis treatment outcomes: a cluster randomized controlled trial in South Africa.

OBJECTIVE: To assess whether adding a training intervention for clinic staff to the usual DOTS strategy (the internationally recommended control strategy for tuberculosis (TB)) would affect the outcomes of TB treatment in primary care clinics with treatment success rates below 70%. METHODS: A cluster randomized controlled trial was conducted from July 1996 to July 2000 in nurse-managed ambulatory primary care clinics in Cape Town, South Africa. Clinics with successful TB treatment completion rates of less than 70% and annual adult pulmonary TB loads of more than 40 patients per year were randomly assigned to either the intervention (n = 12) or control (n = 12) groups. All clinics completed follow-up. Treatment outcomes were measured in cohorts of adult, pulmonary TB patients before the intervention (n = 1200) and 9 months following the training (n = 1177). The intervention comprised an 18-hour experiential, participatory in-service training programme for clinic staff delivered by nurse facilitators and focusing on patient centredness, critical reflection on practice, and quality improvement. The main outcome measure was successful treatment, defined as patients who were cured and those who had completed tuberculosis treatment. FINDINGS: The estimated effect of the intervention was an increase in successful treatment rates of 4.8% (95% confidence interval (CI): -5.5% to 15.2%) and in bacteriological cure rates of 10.4% (CI: -1.2% to 22%). A treatment effect of 10% was envisaged, based on the views of policy-makers on the minimum effect size for large-scale implementation. CONCLUSION: This is the first evidence from a randomized controlled trial on the effects of experiential, participatory training on TB outcomes in primary care facilities in a developing country. Such training did not appear to improve TB outcomes. However, the results were inconclusive and further studies are required.

Adult↗