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Results for “Randomized controlled trials”

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PubMed1989

The implementation of a multicentred randomized controlled trial in the evaluation of the experimental National Health Service nursing homes.

This paper reviews the implementation of a pragmatic multicentred randomized controlled trial in the evaluation of three experimental nursing homes. The organization of services for the care of elderly people varied between the three centres, and each used different criteria for selecting subjects for the trial and different methods of seeking informed consent. Data presented show that in each centre two truly randomized samples have been selected. However, differences between centres, in the characteristics of selected subjects, reflect the implementation of the trials in each of the centres. These findings emphasize the importance of good collaboration between health professionals providing the service, an independent research team, and the establishment of rigorous criteria for inclusion and exclusion of subjects at the outset.

Aged↗

PubMed1992

A randomized controlled trial of dietary fat reduction: the retention of subjects and characteristics of drop outs.

We have examined the feasibility of carrying out a randomized controlled trial of dietary fat reduction in women at increased risk for breast cancer. The randomization was either to a control group who were taught the principles of balanced nutrition, but were not counselled to change their fat intake, or to an intervention group who were taught to reduce their dietary fat intake to 15% of total calories from a baseline average of 35% of calories. Potentially eligible subjects were women attending a breast diagnostic clinic who had the mammographic pattern of dysplasia. Subjects were recruited by letter from their referring surgeon followed by a telephone call. Subjects interested in participating in the study then entered by one of two phases. In Phase I, the study was explained, informed consent sought and willing subjects randomized to the intervention or control group. Using this procedure 227 subjects were randomized and 48 (21%) dropped out of the study in the 12 months following randomization. (A drop out was defined as a subject who persistently failed to keep appointments and provide nutrient data.) Of these drop outs, 30 (63%) occurred at or soon after randomization. A modified procedure of entry was then adopted in which subjects interested in the study were first taught the procedures involved, including keeping food records and clinic appointments, and were then asked to provide consent and randomized. Two hundred and eighty subjects were enrolled using this modified procedure and 25 (9%) have dropped out in the 12 months following randomization.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1991

Effect of triple therapy (antibiotics plus bismuth) on duodenal ulcer healing. A randomized controlled trial.

OBJECTIVE: To determine whether antimicrobial therapy for Helicobacter pylori infection accelerates the healing of duodenal ulcers. DESIGN: Single-blind, randomized, controlled trial. SETTING: Veterans Affairs hospital. PARTICIPANTS: One hundred and five patients with endoscopically verified duodenal ulcers. INTERVENTION: Patients received either ranitidine, 300 mg/d, or ranitidine, 300 mg/d, plus "triple therapy" (2 g/d of tetracycline, 750 mg/d of metronidazole, and 5 or 8 bismuth subsalicylate tablets per day). Triple therapy was administered for only the first 2 weeks of ulcer treatment. MEASUREMENTS: Videoendoscopic assessment of ulcer status was done until ulcer healing was complete. Evaluations were done after 2, 4, 8, 12, and 16 weeks of therapy. MAIN RESULTS: Ulcer healing was more rapid in patients receiving ranitidine plus triple therapy than in patients receiving ranitidine alone (P less than 0.01). The cumulative percentages of patients with healed ulcers in the group receiving ranitidine plus triple therapy and in the group receiving ranitidine alone were as follows: 37% and 18% after week 2; 74% and 53% after week 4; 84% and 68% after week 8; 96% and 80% after week 12; and 98% and 84% after week 16. CONCLUSION: Combined therapy with anti-H. pylori agents and ranitidine was superior to ranitidine alone for duodenal ulcer healing. Our results indicate that H. pylori plays a role in duodenal ulcer disease.

Adult↗

PubMed2004

Chronic pain self-management for older adults: a randomized controlled trial [ISRCTN11899548].

BACKGROUND: Chronic pain is a common and frequently disabling problem in older adults. Clinical guidelines emphasize the need to use multimodal therapies to manage persistent pain in this population. Pain self-management training is a multimodal therapy that has been found to be effective in young to middle-aged adult samples. This training includes education about pain as well as instruction and practice in several management techniques, including relaxation, physical exercise, modification of negative thoughts, and goal setting. Few studies have examined the effectiveness of this therapy in older adult samples. METHODS/DESIGN: This is a randomized, controlled trial to assess the effectiveness of a pain self-management training group intervention, as compared with an education-only control condition. Participants are recruited from retirement communities in the Pacific Northwest of the United States and must be 65 years or older and experience persistent, noncancer pain that limits their activities. The primary outcome is physical disability, as measured by the Roland-Morris Disability Questionnaire. Secondary outcomes are depression (Geriatric Depression Scale), pain intensity (Brief Pain Inventory), and pain-related interference with activities (Brief Pain Inventory). Randomization occurs by facility to minimize cross-contamination between groups. The target sample size is 273 enrolled, which assuming a 20% attrition rate at 12 months, will provide us with 84% power to detect a moderate effect size of.50 for the primary outcome. DISCUSSION: Few studies have investigated the effects of multimodal pain self-management training among older adults. This randomized controlled trial is designed to assess the efficacy of a pain self-management program that incorporates physical and psychosocial pain coping skills among adults in the mid-old to old-old range.

Clinical Trial↗

PubMed2001

Compliance with fecal occult blood test screening among low-income medical outpatients: a randomized controlled trial using a videotaped intervention.

BACKGROUND: Morbidity and mortality from colorectal cancer (CRC) are heightened among the socioeconomically disadvantaged. METHOD: A randomized controlled trial was conducted to evaluate the efficacy of a videotaped intervention using peer educators as well as a health professional to increase compliance with fecal occult blood test (FOBT) screening. Participants were 160 older individuals attending a medical outpatient clinic. Compliance with FOBT use was the dependent measure. Demographic variables, family history of CRC, viewing the videotape, perceived risk, self-efficacy, physician recommendation, knowledge about CRC screening, and intent to use the FOBT were independent measures. RESULTS: Approximately 41% of participants complied with FOBT screening. Significant relationships were found between intent and family history of CRC, viewing the video, perceived risk, self-efficacy, and CRC knowledge. However, none of these variables was significantly related to compliance with FOBT use. CONCLUSIONS: Although modest compliance rates were shown for both experimental and control groups, their compliance did not differ significantly. Further investigation of the impact of a video as part of an enhanced intervention program should be considered.

Analysis of Variance↗

PubMed1996

Exercise effect on dynamic stability in older women: a randomized controlled trial.

OBJECTIVE: To determine whether a 12-month program of regular exercise can improve dynamic postural stability in older women. DESIGN: Randomized controlled trial of 12 months' duration. SETTING: Conducted as part of the Randwick Falls and Fractures Study, in Sydney, Australia. PARTICIPANTS: One hundred and twelve community-dwelling women aged 60 to 85 years (mean age 71.2, SD = 5.4). OUTCOME MEASURES: Quantitative measures of dynamic postural stability: maximal balance range and coordinated stability. MAIN RESULTS: Exercise and control subjects were tested before, midway through, and at the end of the trial. The stability measures had good test-retest reliability, and test performances were significantly associated with measures of lower limb muscle strength, reaction time, neuromuscular control, and body sway. At initial testing, exercisers and controls performed similarly in the two stability measures. The mean number of classes attended for the 48 exercise subjects who completed the program was 58.4 (range 26-77). At the end of the trial, the exercise subjects showed significantly improved performance in both the maximal balance range and coordinated stability tests, with no improvement evident in the controls. Improvements in coordinated stability were associated with corresponding improvements in ankle dorsiflexion, hip extension, and hip flexion strength. CONCLUSION: These findings show that exercise can significantly improve dynamic postural stability in older persons and elucidate some possible mechanisms by which such improvements may be mediated.

Accidental Falls↗

PubMed2005

Challenges in creating a good randomized controlled trial in hand surgery.

The goal of this article is to inform readers of hand surgery literature and, more importantly, investigators about key design issues in randomized trials in hand surgery. Specifically, it describes the application of the Consolidated Standards of Reporting Trials in hand surgery trials and provides tips for reading the hand surgery literature. Unique challenges in the execution of a randomized controlled trial in hand surgery are explained, including the surgical learning curve, randomization, concealment and blinding, loss to follow-up, intention to treat analysis, surgical equipoise, differential care, and treatment effect and its implications for sample size. Additionally, the relevance of incorporating economic analyses into hand surgery trials and the importance of changing the hand surgeons' research culture are addressed.

Costs and Cost Analysis↗

PubMed2000

Community Mothers Programme--seven year follow-up of a randomized controlled trial of non-professional intervention in parenting.

BACKGROUND: The Community Mothers Programme aims at using experienced volunteer mothers in disadvantaged areas to give support to first-time parents in rearing their children up to 1 year of age. The programme was evaluated by randomized controlled trial in 1990. METHODS: Seven years later, trial participants were interviewed about child health, nutrition, cognitive stimulation, parenting skills, and maternal self-esteem. The aim of this study was to see whether the demonstrated benefits at 1 year of age of this programme could be sustained at age 8. RESULTS: One-third of the original group (38 intervention, 38 control), were contacted and interviewed. The risk for having an accident requiring a hospital visit was lower in the intervention group: relative risk (RR) 0.59, 95 per cent confidence interval (CI) 0.31-1.11. Intervention children were more likely to visit the library weekly: RR 1.58, 95 per cent CI 1.10-2.26. Intervention mothers were more likely to check homework every night: RR 1.23, 95 per cent CI 1.05-1.43 (p=0.006); and to disagree with the statement 'children should be smacked for persistently bad behaviour': RR 2.11, 95 per cent CI 1.10-4.06. They were more likely to disagree with the statement 'I do not have much to be proud of': RR 1.24, 95 per cent CI 1.04-1.40; and to make a positive statement about motherhood than controls: RR 1.53, 95 per cent CI 1.06-2.20. Subsequent children of intervention mothers were more likely to have completed Haemophilus influenzae b: RR 1.26, 95 per cent CI 1.06-1.51; and polio immunization: RR 1.19, 95 per cent CI 1.02-1.40. CONCLUSIONS: The Community Mothers programme had sustained beneficial effects on parenting skills and maternal self-esteem 7 years later with benefit extending to subsequent children.

Child↗

PubMed1991

A randomized control trial of two cervical spatulas.

The sampling efficacy of the Ayre and Rocket cervical spatulas was compared in a randomized controlled trial involving 533 women who were attending a colposcopy clinic either for investigation of cytological abnormality or for review after treatment of CIN. Smears were compared with respect to the presence of cytological abnormality and two types of normal cervical epithelial cells (endocervical and immature metaplastic cells) which are considered indicators of adequate cytological sampling. Smears taken with the Rocket spatula were significantly less likely to contain immature metaplastic cells (95% CI on difference in proportion; 5-30%), but more likely to contain endocervical cells (95% CI 16-36%). No significant difference was found in the proportion of smears containing one or other type of indicator cell or in the yield of abnormal smears. It is concluded that the Rocket spatula offered no advantage when used in these circumstances. This study illustrates how spurious conclusions of sampling efficacy can be drawn if only one type of indicator cell is used as an endpoint.

Adult↗

PubMed2006

Applicability and clinical relevance of results in randomized controlled trials: the Cochrane review on exercise therapy for low back pain as an example.

STUDY DESIGN: A critical appraisal of the literature. OBJECTIVES: To increase awareness of the importance of applicability and clinical relevance of the results of randomized controlled trials (RCTs) in the field of spinal disorders by formulating a list of items for assessment of applicability and clinical relevance of results of RCTs. SUMMARY OF BACKGROUND DATA: In systematic reviews of randomized controlled trials (RCTs), critical appraisal of methodologic quality is considered important. Less attention has been paid to the assessment of the applicability and the clinical relevance of the results. METHODS: RCTs in an update of the Cochrane review on exercise therapy for low back pain were used. Most of the trials did not score positively on the five Cochrane Back Review Group basic items describing patients: intervention and setting, outcome, effect size, and benefits related to adverse effects. Item 1 was met by 88% of the trials, but item 2 only by 51%, item 3 by 67%, item 4 by 35%, and item 5 by 0%. Subsequently, a more comprehensive list of items for the assessment of applicability and clinical relevance of results of RCTs was developed. These criteria were pilot tested on the RCTs. After pilot testing and a subsequent consensus meeting, the list of items was drafted and circulated among the members of the Editorial Board of the Cochrane Back Review Group. Changes were made in response to comments. RESULTS: The final list consists of 40 items. The items are ordered on two headings: Does the report enable the assessment of applicability? Are the study results clinically relevant? We present examples of informative and noninformative reporting of RCTs in order to illustrate how information on applicability and clinical relevance of results can be assessed. CONCLUSIONS: Authors of RCTs should adequately report on items that are essential to assess the applicability and clinical relevance of results. The presented list of items may help clinicians reading RCTs and authors of systematic reviews to draw more balanced conclusions on applicability and clinical relevance of results.

Humans↗

PubMed2002

Severe hypertriglyceridemia with insulin resistance is associated with systemic inflammation: reversal with bezafibrate therapy in a randomized controlled trial.

PURPOSE: To determine whether hypertriglyceridemia is associated with systemic inflammation, which may contribute to the increased cardiovascular risk in patients who have hypertriglyceridemia. In addition, we investigated whether fibrates reverse this inflammatory state. PATIENTS AND METHODS: Serum lipid levels, body mass index, insulin resistance, and inflammatory parameters were compared between 18 patients who had severe hypertriglyceridemia without cardiovascular disease and 20 normolipidemic controls. We measured the ex vivo production capacity of tumor necrosis factor (TNF)-alpha and interleukin (IL)-6 after whole-blood stimulation with lipopolysaccharide, as well as circulating levels of C-reactive protein and fibrinogen. A randomized controlled trial was conducted to determine whether bezafibrate (400 mg administered daily for 6 weeks) affected these parameters in hypertriglyceridemic patients. RESULTS: When compared with normolipidemic controls, hypertriglyceridemic patients had significantly lower high-density lipoprotein (HDL) cholesterol and higher triglyceride levels, body mass index, and insulin resistance. In addition, hypertriglyceridemic patients had a significantly higher production capacity of TNF-alpha (mean difference, 11 700 pg/mL; 95% confidence interval [CI]: 7800 to 15,700 pg/mL]) and IL-6 (mean difference, 20,400 pg/mL; 95% CI: 7800 to 32,900 pg/mL), and higher levels of C-reactive protein (mean difference, 0.8 mg/L; 95% CI: 0.1 to 2.4 mg/L) and fibrinogen (mean difference, 0.8 g/dL; 95% CI: 0.3 to 1.3 g/dL). Bezafibrate therapy significantly increased HDL cholesterol levels, reduced triglyceride and insulin resistance levels, and reduced production capacity of TNF-alpha and IL-6, as well as levels of C-reactive protein and fibrinogen. CONCLUSION: Systemic inflammation is present in patients who have the clinical phenotype that is associated with severe hypertriglyceridemia, and may contribute to the increased risk of cardiovascular disease in these patients. Bezafibrate has anti-inflammatory effects in these patients.

Bezafibrate↗

PubMed2006

Lifestyle interventions to reduce raised blood pressure: a systematic review of randomized controlled trials.

PURPOSE: To quantify effectiveness of lifestyle interventions for hypertension. DATA SOURCES: Electronic bibliographic databases from 1998 onwards, existing guidelines, systematic reviews. STUDY SELECTION AND DATA ABSTRACTION: We included randomized, controlled trials with at least 8 weeks' follow-up, comparing lifestyle with control interventions, enrolling adults with blood pressure at least 140/85 mmHg. Primary outcome measures were systolic and diastolic blood pressure. Two independent reviewers selected trials and abstracted data; differences were resolved by discussion. RESULTS: We categorized trials by type of intervention and used random effects meta-analysis to combine mean differences between endpoint blood pressure in treatment and control groups in 105 trials randomizing 6805 participants. Robust statistically significant effects were found for improved diet, aerobic exercise, alcohol and sodium restriction, and fish oil supplements: mean reductions in systolic blood pressure of 5.0 mmHg [95% confidence interval (CI): 3.1-7.0], 4.6 mmHg (95% CI: 2.0-7.1), 3.8 mmHg (95% CI: 1.4-6.1), 3.6 mmHg (95% CI: 2.5-4.6) and 2.3 mmHg (95% CI: 0.2-4.3), respectively, with corresponding reductions in diastolic blood pressure. Relaxation significantly reduced blood pressure only when compared with non-intervention controls. We found no robust evidence of any important effect on blood pressure of potassium, magnesium or calcium supplements. CONCLUSIONS: Patients with elevated blood pressure should follow a weight-reducing diet, take regular exercise, and restrict alcohol and salt intake. Available evidence does not support relaxation therapies, calcium, magnesium or potassium supplements to reduce blood pressure.

Administrative Personnel↗

PubMed1994

A randomized controlled trial of cold-adapted and inactivated vaccines for the prevention of influenza A disease.

A double-blind, randomized controlled trial over 5 years compared the safety, immunogenicity, and efficacy of cold-adapted and inactivated influenza A vaccines in 5210 normal subjects. Both vaccines were well tolerated. Inactivated vaccine significantly increased hemagglutination inhibition antibody titers. Significant titer rises were also noted after cold-adapted vaccine but of lesser magnitude than with inactivated vaccine. The efficacy of inactivated vaccine in preventing culture-positive influenza was 76% (95% confidence interval [CI], 58%-87%) for H1N1 disease and 74% (95% CI, 52%-86%) for H3N2; for cold-adapted vaccine, 85% (95% CI, 70%-92%) and 58% (95% CI, 29%-75%), respectively. The efficacy of inactivated vaccine in preventing a four-fold rise in antibody titer over the influenza season was 69% (95% CI, 61%-76%) for H1N1 and 73% (95% CI, 65%-79%) for H3N2; for cold-adapted vaccine, 54% (95% CI, 44%-62%) and 32% (95% CI, 17%-44%), respectively. Cold-adapted and inactivated influenza vaccines are safe and effective for preventing influenza A disease.

Administration, Intranasal↗

PubMed2005

Fracture prevention with vitamin D supplementation: a meta-analysis of randomized controlled trials.

CONTEXT: The role and dose of oral vitamin D supplementation in nonvertebral fracture prevention have not been well established. OBJECTIVE: To estimate the effectiveness of vitamin D supplementation in preventing hip and nonvertebral fractures in older persons. DATA SOURCES: A systematic review of English and non-English articles using MEDLINE and the Cochrane Controlled Trials Register (1960-2005), and EMBASE (1991-2005). Additional studies were identified by contacting clinical experts and searching bibliographies and abstracts presented at the American Society for Bone and Mineral Research (1995-2004). Search terms included randomized controlled trial (RCT), controlled clinical trial, random allocation, double-blind method, cholecalciferol, ergocalciferol, 25-hydroxyvitamin D, fractures, humans, elderly, falls, and bone density. STUDY SELECTION: Only double-blind RCTs of oral vitamin D supplementation (cholecalciferol, ergocalciferol) with or without calcium supplementation vs calcium supplementation or placebo in older persons (> or =60 years) that examined hip or nonvertebral fractures were included. DATA EXTRACTION: Independent extraction of articles by 2 authors using predefined data fields, including study quality indicators. DATA SYNTHESIS: All pooled analyses were based on random-effects models. Five RCTs for hip fracture (n = 9294) and 7 RCTs for nonvertebral fracture risk (n = 9820) met our inclusion criteria. All trials used cholecalciferol. Heterogeneity among studies for both hip and nonvertebral fracture prevention was observed, which disappeared after pooling RCTs with low-dose (400 IU/d) and higher-dose vitamin D (700-800 IU/d), separately. A vitamin D dose of 700 to 800 IU/d reduced the relative risk (RR) of hip fracture by 26% (3 RCTs with 5572 persons; pooled RR, 0.74; 95% confidence interval [CI], 0.61-0.88) and any nonvertebral fracture by 23% (5 RCTs with 6098 persons; pooled RR, 0.77; 95% CI, 0.68-0.87) vs calcium or placebo. No significant benefit was observed for RCTs with 400 IU/d vitamin D (2 RCTs with 3722 persons; pooled RR for hip fracture, 1.15; 95% CI, 0.88-1.50; and pooled RR for any nonvertebral fracture, 1.03; 95% CI, 0.86-1.24). CONCLUSIONS: Oral vitamin D supplementation between 700 to 800 IU/d appears to reduce the risk of hip and any nonvertebral fractures in ambulatory or institutionalized elderly persons. An oral vitamin D dose of 400 IU/d is not sufficient for fracture prevention.

Aged↗

PubMed2026

Bioabsorbable vs. titanium screws in first metatarsophalangeal joint arthrodesis: a pilot randomized controlled trial with 2-year follow-up.

INTRODUCTION: To assess the feasibility and preliminary clinical outcomes of bioabsorbable screw fixation in first metatarsophalangeal joint arthrodesis compared to conventional titanium screw fixation. METHODS: In this prospective pilot randomized controlled trial, 30 patients were allocated 1:1 to bioabsorbable or titanium cannulated lag screw fixation. Arthrodesis was performed using a cup-and-cone technique at two Finnish hospitals. Full weight-bearing in an orthopaedic shoe was allowed after six weeks. Outcomes included AOFAS and VA-FAS FA-VAS scores, union rates, and complications assessed at 3, 6, 12, and 24 months. RESULTS: Both groups showed significant functional improvement with no between-group differences. At 24 months, mean AOFAS scores were 89.1 (SD 2.7) in the titanium group and 90.0 (SD 0.0) in the bioabsorbable group (p = 0.23). Mean FA-VAS total scores (sum of pain, function, and complaints subscales) were 1948 (SE 59.4) in the titanium group and 1914 (SE 61.4) in the bioabsorbable group (p = 0.655). Union rate was 90% overall; nonunion occurred in one titanium and two bioabsorbable patients, all requiring revision. No implant-related complications or hardware removal surgeries were recorded. Degradation of bioabsorbable screws caused no adverse clinical or radiographic reactions. CONCLUSIONS: Bioabsorbable screws appear safe and feasible in first metatarsophalangeal joint arthrodesis, with preliminary outcomes comparable to titanium fixation. These findings support the conduct of a larger confirmatory trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03133039, registered 28 April 2017. https://clinicaltrials.gov/ct2/show/NCT03133039.

Humans↗

PubMed2003

Temporomandibular disorders in adolescents. Epidemiological and methodological studies and a randomized controlled trial.

The aim of the present thesis was to investigate different aspects of temporomandibular disorders (TMD) and pain such as prevalence, diagnostics, and treatment among adolescents. The reliability of a questionnaire and the clinical examination and diagnoses according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) were assessed. Overall, we found it possible to assess and diagnose TMD in adolescents in a reliable way. The prevalence of TMD pain, gender differences, and the need for treatment were investigated among 864 adolescents from a Public Dental Service clinic. Seven percent of the subjects received a pain diagnosis according to the RDC/TMD, and the prevalence was higher among girls than boys. More subjects with TMD pain reported school absence and analgesic consumption compared to controls. Approximately every second subject who reported TMD pain also perceived a need for treatment. In an evaluation of psychosocial and dental factors, the following were found to play an important role in adolescents with TMD: stress, somatic complaints, and emotional problems. Three treatment methods were compared in a randomized controlled trial: brief information only, brief information and occlusal appliance, and brief information and relaxation therapy. In the brief information and occlusal appliance group, 60%--significantly more than in the other two groups--experienced a reduction of at least 50% in TMD pain. The influence of somatic and emotional stimuli was evaluated, and we found that adolescents with TMD pain were significantly more sensitive to not only aversive somatic but also pleasant somatic stimuli compared with healthy controls. The results suggest that not only nociceptive but also cognitive processes are implicated in chronic pain states in young TMD subjects. In conclusion, TMD pain is more common in girls than in boys and affects daily life. TMD pain in adolescents can best be improved by traditional treatment with occlusal appliance combined with brief information.

Adolescent↗

PubMed2002

Telemedicine for new neurological outpatients: putting a randomized controlled trial in the context of everyday practice.

In a retrospective review, the telemedical management of 65 outpatients from a randomized controlled trial (RCT) of telemedicine for non-urgent referrals to a consultant neurologist was compared with the management of 76 patients seen face to face in the same trial, with that of 150 outpatients seen in the neurology clinics of district general hospitals and with that of 102 neurological outpatients seen by general physicians. Outcome measures were the numbers of investigations and of patient reviews. The telemedicine group did not differ significantly from the 150 patients seen face to face by neurologists in hospital clinics in terms of either the number of investigations or the number of reviews they received. Patients from the RCT seen face to face had significantly fewer investigations but a similar number of reviews to the other 150 patients seen face to face by neurologists (the disparity in the number of investigations may explain the negative result for telemedicine in that RCT). Patients with neurological symptoms assessed by general physicians had significantly more investigations and were reviewed significantly more often than all the other groups. Patients from the RCT seen by telemedicine were not managed significantly differently from those seen face to face by neurologists in hospital clinics but had significantly fewer investigations and follow-ups than those patients managed by general physicians. The results suggest that management of new neurological outpatients by neurologists using telemedicine is similar to that by neurologists using a face-to-face consultation, and is more efficient than management by general physicians.

Adolescent↗

PubMed2002

Is roxithromycin better than amoxicillin in the treatment of acute lower respiratory tract infections in primary care? A double-blind randomized controlled trial.

OBJECTIVE: To assess the efficacy of roxithromycin relative to amoxicillin. STUDY DESIGN: We conducted a double-blind randomized controlled trial of oral 500 mg amoxicillin 3 times per day vs oral 300 mg roxithromycin once a day for 10 days. POPULATION: We included 196 adults who had presented to a general practitioner with lower respiratory tract infection (LRTI) and, in the physician's opinion, needed antibiotic treatment. OUTCOMES MEASURED: We measured clinical response after 10 and 28 days, defined in 4 ways: (1) decrease in LRTI symptoms; (2) complete absence of symptoms; (3) decrease in signs; and (4) complete absence of signs. Self-reported response included the decrease in symptoms and the time until resumption of impaired or abandoned daily activities on days 1 through 10, 21, and 27. RESULTS: Clinical cure rates after the completion of antibiotic treatment (10 days) were not significantly different for the 2 groups. After 28 days, the roxithromycin group showed no increase in cure rate as evidenced by the decrease in symptoms, indicating a significantly lower cure rate. However, this difference did not alter physicians' overall conclusion after complete follow-up that 90% of patients, regardless of age, had been effectively treated with either amoxicillin or roxithromycin. CONCLUSIONS: The surplus value of roxithromycin was not confirmed. Amoxicillin remains a reliable first-choice antibiotic in the treatment of LRTI in general practice.

Adult↗