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At least 19 recordsLinked to original sources
PubMed1983

Bias in treatment assignment in controlled clinical trials.

Controlled clinical trials of the treatment of acute myocardial infarction offer a unique opportunity for the study of the potential influence on outcome of bias in treatment assignment. A group of 145 papers was divided into those in which the randomization process was blinded (57 papers), those in which it may have been unblinded (45 papers), and those in which the controls were selected by a nonrandom process (43 papers). At least one prognostic variable was maldistributed (P less than 0.05) in 14.0 per cent of the blinded-randomization studies, in 26.7 per cent of the unblinded-randomization studies, and in 58.1 per cent of the nonrandomized studies. Differences in case-fatality rates between treatment and control groups (P less than 0.05) were found in 8.8 per cent of the blinded-randomization studies, 24.4 per cent of the unblinded-randomization studies, and 58.1 per cent of the nonrandomized studies. These data emphasize the importance of keeping those who recruit patients for clinical trials from suspecting which treatment will be assigned to the patient under consideration.

Clinical Trials as Topic↗
PubMed1982

Moore hemi-arthroplasty with and without bone cement in femoral neck fractures. A clinical controlled trial.

In a clinical, controlled trial 112 patients with fresh femoral neck fractures were allocated to two groups of treatment: 55 patients had a Moore hemi-arthroplasty cemented with methyl methacrylate and 57 patients a non-cemented prosthesis. 75 patients attended the follow-up study. At 6 weeks, 3 months, 6 months and 12 months after the operation the function of the hip was assessed according to Merle d'Aubigné. At 6 weeks, 3 months and 6 months after the operation the clinical results were significantly better among patients with cemented prosthesis, especially in relation to pain relief and gait function. It is concluded that fixation of the prosthesis with cement improves the clinical results, at least during the first 6 months following the operation.

Aged↗
PubMed1990

[Clinical controlled trial for secondary caries preventive effect of Duraphat on cavity walls].

On a base of a clinical controlled trial the secondary caries preventive effect of a topical application of fluoride varnish (Duraphat) was verified. 255 pairs of amalgam restorations were placed in 191 patients, 152 (79.6%) of whom returned for assessment after a 24 month follow-up period. This group of 152 patients received 188 (73.7%) pairs of restorations. The cavity walls of one restoration of each pair were covered with an thin layer of a fluoride containing varnish. The secondary caries rate of the untreated restorations in such manner was four time greater than the treated ones. The results suggest that the topical application of a fluoride varnish on the cavity walls can be an effective measure for secondary caries prevention.

Adolescent↗
PubMedDate not supplied

Medical ethics and controlled clinical trials.

The controlled clinical trial is a relatively new phenomenon; the first large clinical trial on evaluation of streptomycin in therapy of pulmonary tuberculosis occurred in 1946. In such a study, two or more groups of patients with similar characteristics are chosen by random allocation to receive one or more therapies. The essential ethical dilemma is based on the risk-benefit ratio of the new therapy. Ethical factors that must be considered in the design of controlled clinical trials include provision for informed consent, nature of alternate therapy, confidentiality of data, source of funding and potential conflict of interest, remuneration of subjects, criteria for ending participation of the subject, criteria for concluding the trial, compensation of injured subjects, compliance with institutional, municipal, state and federal regulations and provisions for special groups such as the fetus and pregnant woman, infants and young children, institutional patients and prisoners. Federal guidelines for research in specific areas are now available through the reports of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. To date, commission reports include recommendations for research in fetuses and pregnant women and in children. Protection of the subject is best provided by the the quality of the protocol, integrity of the investigator, valid informed consent, and review of the research program by an independent committee composed of scientists and consumers.

Child↗
PubMed1978

Chlorambucil dosage in frequently relapsing nephrotic syndrome: a controlled clinical trial.

A controlled clinical trial was performed using two dosage regimens of chlorambucil to treat children with frequently relapsing nephrotic syndrome. All children concurrently received prednisone (60 mg/m2 on alternate days). Ten children (Group I) were given chlorambucil as a stable dose (0.2 mg/kg/day) for 56 to 60 days, and 11 children (Group II) received increasing doses (0.2 to 0.63 mg/kg/day) for 42 to 77 days. Two children in each group subsequently relapsed. Follow-up averaged 28.6 and 27.2 months in Groups I and II, respectively. Three children in Group II developed infectious complications. The data indicate that a stable dosage regimen for chlorambucil is as effective as an increasing dose regimen in achieving long-term remission of frequently relapsing nephrotic syndrome.

Adolescent↗
PubMed1992

Hypnosis or cognitive behavioral training for the reduction of pain and nausea during cancer treatment: a controlled clinical trial.

Few controlled clinical trials have tested the efficacy of psychological techniques for reducing cancer pain or post-chemotherapy nausea and emesis. In this study, 67 bone marrow transplant patients with hematological malignancies were randomly assigned to one of four groups prior to beginning transplantation conditioning: (1) hypnosis training (HYP); (2) cognitive behavioral coping skills training (CB); (3) therapist contact control (TC); or (4) treatment as usual (TAU; no treatment control). Patients completed measures of physical functioning (Sickness Impact Profile; SIP) and psychological functioning (Brief Symptom Inventory; BSI), which were used as covariates in the analyses. Biodemographic variables included gender, age and a risk variable based on diagnosis and number of remissions or relapses. Patients in the HYP, CB and TC groups met with a clinical psychologist for two pre-transplant training sessions and ten in-hospital "booster" sessions during the course of transplantation. Forty-five patients completed the study and provided all covariate data, and 80% of the time series outcome data. Analyses of the principal study variables indicated that hypnosis was effective in reducing reported oral pain for patients undergoing marrow transplantation. Risk, SIP, and BSI pre-transplant were found to be effective predictors of inpatient physical symptoms. Nausea, emesis and opioid use did not differ significantly between the treatment groups. The cognitive behavioral intervention, as applied in this study, was not effective in reducing the symptoms measured.

Adult↗
PubMed1995

Relaxation and imagery and cognitive-behavioral training reduce pain during cancer treatment: a controlled clinical trial.

Few controlled clinical trials of psychological interventions for cancer pain relief exist in spite of frequent support for their importance as adjuncts to medical treatment. This study compared oral mucositis pain levels in 4 groups of cancer patients receiving bone marrow transplants (BMT): (1) treatment as usual control, (2) therapist support, (3) relaxation and imagery training, and (4) training in a package of cognitive-behavioral coping skills which included relaxation and imagery. A total of 94 patients completed the study which involved two training sessions prior to treatment and twice a week 'booster' sessions during the first 5 weeks of treatment. Results confirmed our hypothesis that patients who received either relaxation and imagery alone or patients who received the package of cognitive-behavioral coping skills would report less pain than patients in the other 2 groups. The hypothesis that the cognitive-behavioral skills package would have an additive effect beyond relaxation and imagery alone was not confirmed. Average visual analogue scale (VAS) report of pain within the therapist support group was not significantly lower than the control group (P = 0.103) nor significantly higher than the training groups. Patient reports of relative helpfulness of the interventions for managing pain and nausea matched the results of VAS reports. From these results, we conclude that relaxation and imagery training reduces cancer treatment-related pain; adding cognitive-behavioral skills to the relaxation with imagery does not, on average, further improve pain relief.

Adaptation, Psychological↗
PubMed1995

No detrimental effect of fibrin glue on the regeneration of intrabony defects. A controlled clinical trial.

This controlled clinical trial evaluated the potential of fibrin glue as a biological carrier to locally deliver guided tissue regeneration (GTR) modulators, 2 controlateral, morphologically similar defects were selected in each of 11 patients and randomly assigned to the test (teflon membrane and fibrin glue) and the control treatment (teflon membrane alone). Outcomes were assessed at membrane removal as newly formed granulation tissue and at the 1-year follow-up in terms of changes in probing attachment level, probing pocket depth, recession of the gingival margin, probing bone levels and percentage of fill of the intrabony defects. Data confirmed that GTR treatment of deep intrabony defects results in clinically and statistically significant improvements of the clinical parameters. No significant differences, however, were evidenced between the test and the control treatments. It is suggested that, since fibrin glue did not show detrimental effects on GTR, it could be applied as a biological carrier for the delivery of GTR enhancers into the surgical wound.

Adult↗
PubMed1975

Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial.

In controlled clinical trials there are usually several prognostic factors known or thought to influence the patient's ability to respond to treatment. Therefore, the method of sequential treatment assignment needs to be designed so that treatment balance is simultaneously achieved across all such patients factor. Traditional methods of restricted randomization such as "permuted blocks within strata" prove inadequate once the number of strata, or combinations of factor levels, approaches the sample size. A new general procedure for treatment assignment is described which concentrates on minimizing imbalance in the distributions of treatment numbers within the levels of each individual prognostic factor. The improved treatment balance obtained by this approach is explored using simulation for a simple model of a clinical trial. Further discussion centers on the selection, predictability and practicability of such a procedure.

Carmustine↗
PubMed1996

Acute and chronic changes in atrial natriuretic factor induced by ventricular pacing: a self controlled clinical trial.

A self controlled clinical trial was carried out to study the acute and chronic effects of ventricular pacing (VVI) on the atrial natriuretic factor (ANF). Eleven people were selected from a pool of 20 DDD paced patients. Pacemakers were programmed to the VVI mode for 1 month and their effectiveness tested by ECG at rest and after an effort test. AnF was measured by radioimmunoassay at baseline, after 15 minutes, and again 1 month after programming. The reliability of the radioimmunoassay was confirmed using the coefficients of variation between (12.5%) and within assay (9.7%). Data analysis was done using Wilcoxon's test. Our results showed that the onset of VVI pacing led to a sudden sharp rise in ANF in all patients (P < 0.0001). During VVI pacing, three patients were dropped from the study (2 were withdrawn because of symptoms and 1 voluntarily withdrew). After 1 month of VVI pacing, a significant increase of ANF above the baseline was observed (P < 0.05). The results showed that ventricular pacing led to an immediate rise in ANF and, that with long-term VVI pacing, there was an increase in ANF levels as well. The role of these findings in the pathophysiology of the pacemaker syndrome calls for further research.

Adult↗
PubMed1989

A clinical controlled trial of endoscopic sclerotherapy for repeated esophageal variceal bleeding.

Thirty-seven patients with postnecrotic cirrhosis of the liver and 13 patients with primary hepatoma were proven to have repeated bleeding from ruptured esophageal varices. Clinically controlled trials were performed by assigning patients to either sclerotherapy or control arms (25 patients each). Combined intra-variceal and para-variceal injection before an upper endoscopic examination was performed in the sclerotherapy group. In all 25 sclerotherapy cases (100%) hemostasis was successful, which was a statistically significant success rate compared to the control group (52.0%) (p less than 0.01). In the sclerotherapy group 20% (5/25 cases) developed rebleeding, which was less than the 48.0% (7 cases of continuous bleeding and 5 cases of rebleeding) of the control group (p less than 0.05). Four cases (16.0%) in the sclerotherapy group died of erosive gastritis with massive bleeding, compared to 8 fatalities (32.0%) in the control group, because of uncontrolled esophageal variceal bleeding. Endoscopic sclerotherapy is a very effective method for arresting bleeding esophageal varices, and for decreasing the rebleeding rate.

Adult↗
PubMed1988

Bulk fracture of amalgam restorations--a 5-year controlled clinical trial.

A controlled clinical study, containing 720 posterior amalgam restorations placed in a group of 103 adult patients by three dentists, was used for examination of the influences on the incidence of occlusal and approximal bulk fractures. These fractures were evaluated from black and white photographs, taken annually, of the occlusal surface of the restorations over a 5-year period, using a three point photo-rating scale for both fracture sites. The influence of the dentist as well as the influence of the alloy and tooth type were statistically analysed. The results of these analyses demonstrated that the dentist, as well as the alloy and tooth type, have a statistically significant influence on the incidence of bulk fracture of amalgam restorations.

Adult↗
PubMed1989

The trials of clinical trials.

Controlled clinical trials are becoming increasingly frequent in neurology. A review of the literature indicates that several trials have serious flaws in study design and conduct that render the results questionable or uninterpretable. These reports, together with my own experience with the trial of plasmapheresis in the treatment of acute Guillain-Barré syndrome, have led me to conclude that while the formulation of the crucial research question and the definition of outcomes as a measure of efficacy are extremely important, the availability of a compliant patient population of appropriate size and the compliance by the study physicians are essential. Moreover, close cooperation with the statistician in planning the trial and the statistical strategy for analysis is also critical. Suggestions are made to aid the clinician in setting up the most efficacious trial and reporting the results.

Clinical Trials as Topic↗
PubMed1999

[Hypnosis and self-hypnosis administered and taught by nurses for relief of chronic pain: a controlled clinical trial].

In this controlled clinical trial hypnosis and self-hypnosis were evaluated when used as an adjuvant treatment to instrumental and pharmacological management of chronic pain. The study took place in a hospital specialized in the treatment of outpatients suffering from chronic pain. Hypnosis and self-hypnosis were administered and taught by nurses who had been trained just recently for this very purpose. Under the conditions of the study it was not possible to measure an effect of hypnosis on pain despite some subjective feeling of usefulness. However, it should be taken into account that this form of adjuvant therapy was used for the first time in that hospital for the purpose of the study and, therefore, took place in an artificial setting. It could well be that the same therapy administered in the proper therapeutic environment of a specialized institution could show beneficial effects on pain.

Autosuggestion↗
PubMed1977

Long-term treatment with sulphamethoxazole/trimethoprim (Bactrim) and nitrofurantoin in chronic urinary tract infections. A controlled clinical trial.

In a controlled clinical trial based on 30 geriatric patients with recurrent urinary tract infection, 12 out of 17 patients fulfilled a 12-month treatment with sulphamethoxazole/trimethoprim (Bactrim) with continuous sterile urine compared to 1 out of 13 patients treated with nitrofurantoin (p less than 0.05). There was a slight but statistically significant increase in serum creatinine during treatment for 12 months in the sulphamethoxazole/trimethoprim group, but this probably does not reflect any deterioration in kidney function. The remaining laboratory values showed no significant changes whatsoever.

Aged↗