Plea for better protocols in clinical research.
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Clinical Trials as Topic↗
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Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.
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Aide-mémoire for preparing clinical trial protocols.
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Drug Evaluation↗
Quality, efficiency, and cost of a physician-assistant-protocol system for managment of diabetes and hypertension.
Briefly trained physicians assistants using protocols (clinical algorithms) for diabetes, hypertension, and related chronic arteriosclerotic and hypertensive heart disease abstrated information from the medical record and obtained history and physical examination data on every patient-visit to a city hospital chronic disease clinic over a 18-month period. The care rendered by the protocol system was compared with care rendered by a "traditional" system in the same clinic in which physicians delegated few clinical tasks. Increased thoroughness in collecting clinical data in the protocol system led to an increase in the recognition of new pathology. Outcome criteria reflected equivalent quality of care in both groups. Efficiency time-motion studies demonstrated a 20 per cent saving in physician time with the protocol system. Coct estimates, based on the time spent with patients by various providers and on the laboratory-test-ordering patterns, demonstrated equivalent costs of the two systems, given optimal staffing patterns. Laboratory tests were a major element of the cost of patient care,and the clinical yield per unit cost of different tests varied widely.
Costs and Cost Analysis↗
Clinical, genetic and bioinformatic analysis of Saudi families with Joubert syndrome and related disorders.
BACKGROUND: Joubert syndrome and related disorders (JSRD) are clinically and genetically heterogeneous ciliopathies caused by pathogenic variants in over 40 genes, mainly encoding ciliary proteins. However, data on JSRD in the Saudi population remain limited. This study aimed to identify novel and reported JSRD-causing variants in Saudi families and analyze their potential functional impact on protein structure using advanced computational tools. METHODS: Patients with genetically or clinically confirmed/suspected JSRD were recruited according to ethical protocols. Clinical data were collected, and exome sequencing was performed, followed by Sanger validation of identified variant. Pathogenicity was assessed using bioinformatics tools, while conservation, expression and RNA structure analyses were conducted to evaluate the potential functional consequences. RESULTS: Homozygous variants were identified in three consanguineous Saudi families, including a novel stop-gain variant in KIF7 (c.2992 C > T; p.(Gln998Ter)), and novel splice-site variant in CEP104 (c.489 + 1G > A) and a previously reported splice-site variant in TMEM237 (c.869 + 1G > A). All variants were predicted to be pathogenic as per ACMG criteria and located in highly conserved regions, suggesting potential functional impact. RNA analysis suggested possible alterations in folding. CONCLUSION: This study identified three pathogenic variants in JSRD-related genes in Saudi families, including two novel variants. These findings expand the variant spectrum for JSRD, particularly in the Saudi population. Establishing a comprehensive regional variant database is essential for improving molecular diagnosis and genetic counseling in population with high consanguinity. Finally, these results highlight the need for further functional studies to validate their pathogenicity and elucidate their role in JSRD pathogenesis.
Humans↗
Randomized controlled clinical trial. National Eye Institute workshop for ophthalmologists. Writing the protocol for a clinical trial.
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Clinical Trials as Topic↗
The costs of an institutional review board.
The Institutional Review Board (IRB) at the University of Texas Health Science Center at San Antonio is charged with the responsibility of review of all protocols involving human subjects in research. A large medical institution has many clinical protocols requiring review. The review of hundreds of protocols per year requires much time from the IRB staff, the committees which review the protocols, and the investigators who prepare them. This cost is borne by the institution. Additional federal regulations add to the complexity of review and require additional time on the part of all concerned. An attempt has been made to document the costs of operation of the IRB in a single group of institutions. About 850 new or renewal applications are reviewed each year for $100,000 or about $100 per application. This is a sizable financial burden to be placed on the average medical school. Legislation is now proposed to support IRB activities by direct grants from the federal government.
Costs and Cost Analysis↗
[The definition of a reference protocol for the clinical study of vertigo drugs].
The aim of this paper is to define the problems that arise in the clinical evaluation of drugs for the treatment of vertigo. Among these are the objective criteria used in defining vertigo and those used in evaluating efficacy of the drugs. The resulting protocol for a clinical study of vestibular drugs is a document that clarifies the debated points in the field, and above all furnishes guidelines for establishing uniformity in clinical studies. This, therefore, may become the reference protocol in Italy for clinical evaluations of drugs for the treatment of vertigo.
Clinical Protocols↗
Calories count. Improved weight gain with dietary intervention in congenital heart disease.
OBJECTIVES: We assessed the nutritional status of patients with congenital heart disease (CHD) to evaluate the role of dietary intake in impaired weight for patient length. Underweight patients with CHD underwent nutritional counseling to evaluate the role of this intervention in improvement of weight for length. RESEARCH DESIGN: We prospectively evaluated a clinical protocol for nutritional assessment and counseling in patients with CHD. Eligible patients were enrolled from a cardiology clinic during a 13-month period. Initial anthropometric measurements and measurements of dietary intake of underweight and normal-weight patients were compared. Initial and follow-up measurements of underweight patients who received nutritional counseling were compared. PATIENTS: Nineteen underweight patients with CHD and 16 normal-weight patients with CHD, aged 1 month to 2 years, were studied. Exclusion criteria included noncardiac factors that could affect growth (eg, low birth weight, Down syndrome, gastrointestinal deficit, and any severe abnormality of the central nervous system). Seventeen of the 19 underweight patients underwent nutritional counseling in the presence of a parent every 2 months for 6 months. Caloric and protein intakes were maximized using high-calorie formulas. MEASUREMENTS AND RESULTS: Baseline dietary intake was lower in underweight patients than in normal-weight patients (mean percentage of the recommended daily allowance of calories, 89% vs 108%). Follow-up evaluation in normal-weight patients showed no change in percentage of ideal body weight for length. Follow-up evaluation in underweight patients showed improvement in mean dietary intake (from 90% to 104% of the recommended daily allowance of calories) and in mean percentage of ideal body weight for length after intervention (from 83.1% to 88.3%). CONCLUSION: Nutritional evaluation of patients with CHD demonstrated that underweight children had inadequate diets. Underweight patients with CHD who received nutritional counseling showed increased dietary intake and improved anthropometric measurements on follow-up.
Anthropometry↗
[Sulfasalazine in the treatment of rheumatoid arthritis. A multicenter open study of 150 patients during 6 months].
One hundred and fifty patients with rheumatoid arthritis were given sulfasalazine in a daily dosage of 2 g during an open-label, multicenter, six-month trial. Improvements were apparent as early as four weeks after initiation of the drug. Improvements in clinical parameters and erythrocyte sedimentation rate were statistically significant. In the patients who remained on the study protocol, clinical and biological improvements continued over time and were more marked after six months. Overall clinical safety was satisfactory: 30 patients were withdrawn from the trial for adverse events, all of which resolved after discontinuation of the study drug. Most of these adverse events (93%) developed within two months of initiation of the drug, demonstrating the need for hematologic and hepatic tests at regular intervals during the first three months of sulfasalazine therapy. Thirty-four patients had not previously received maintenance therapy; in this subgroup, only one patient was withdrawn for ineffectiveness. In view of its favorable risk/benefit ratio and fast action, sulfasalazine may be a useful first-line drug in patients with rheumatoid arthritis.
Aged↗
The application of clinical trials to solid tumour management: an introduction.
This paper discusses the relevance of clinical trials to the management of solid tumours. It introduces the types of clinical trials, the requirements for patient assessment, and an overall strategy for importance of statistical and ethical considerations is discussed. There is an invitation for practising surgeons to participate in trials relevant to their speciality. The necessay framework and requirements for a clinical protocol are discussed separately in the following paper.
Breast Neoplasms↗
ERCC1 and ERCC2 expression in malignant tissues from ovarian cancer patients.
BACKGROUND: ERCC1 and ERCC2 are human DNA repair genes that are associated with in vitro resistance to selected DNA-damaging agents. PURPOSE: Fresh tumor tissues from 26 patients with ovarian cancer were analyzed for the RNA levels of expression of these genes to determine possible clinical relevance. METHODS: Tumor tissues were harvested from patients immediately before they entered a cisplatin- or carboplatin-based treatment protocol. Clinical response was assessed by standard criteria. Gene expression level was assessed by slot blot analysis, using beta-actin as a control. Relative expression levels were determined by comparing each tumor sample with a Chinese hamster ovary cell line that had a stable transfection of the human ERCC1 gene. RESULTS: Patients who were clinically resistant to platinum-based therapy had a 2.6-fold higher expression level of ERCC1 in their tumor tissue than did patients who responded to that therapy (P = .015). Results obtained by slot blot analysis were qualitatively confirmed by polymerase chain reaction analysis. Relative levels of expression of ERCC2 did not differ significantly between responders and nonresponders. CONCLUSION: We conclude that ERCC1 expression levels in human tumor tissue may have a role in clinical resistance to platinum compounds. These data appear to be consistent with the assertion that ERCC1 serves as an excision nuclease, whereas ERCC2 serves as a helicase.
Blotting, Southern↗
Controlled clinical trial of pediatric telephone protocols.
A randomized clinical trial of pediatric protocols administered by health assistants demonstrated an alternate method of handling telephone complaints in a large emergency room. The new system advised a higher medical examination rate than the current system in the emergency room probably bacause the current system has deficits with respect to collecting necessary information and making explicit decisions. This higher rate of recommended visits demonstrated in the emergency room was not confirmed in the two pediatric primary-care settings in which the protocol system was also tested. In addition to this use, the telephone protocols may also be useful in training medical and nursing students, in handling telephone complaints similar to a poison control center, in triaging problems in a rural or emergency medical service, and in providing a record of the telephone call.
Age Factors↗
[Advantages of the initial therapy of acute schizophrenia with large doses of droperidol/A comparative study (author's transl)].
The treatment of acute schizophrenic disorders with large doses of droperidol was compared to clozapine and clopenthixol in a special study. Apart from the clinical protocol, psychometric test for the assessment of social behaviour and thought disorders were used. The advantages of the treatment with droperidol, especially in highly disturbed acute schizophrenic patients, are shown and discussed by means of the results of psychological tests and clinical experience.
Acute Disease↗
Megestrol acetate in treatment of benign prostatic hypertrophy.
In this study we found no significant effect on benign prostatic hypertrophy due to megestrol using standard clinical criteria. However, there is evidence using urinary drop spectrometer data which makes one suspect that megestrol does have a positive effect. If there is an effect, it is apparently so small as to be undetectable using the clinical protocol of this investigation. Since the urodynamic evidence does indicate a possibility of a positive effect, it appears reasonable to investigate further using a different protocol - perhaps a higher dosage and/or a more controlled test population.
Clinical Trials as Topic↗
Treatment of obesity by acupuncture.
Twenty-four subjects ranging from 5 to 33% above ideal weight were weighted during a 3-week control period, and then treated for the successive 9 weeks with acupuncture therapy given in three different loci, and in random order for 3-week periods. The acupuncture needles were placed in unilateral loci used by oriental acupuncturists for weight loss, in the same loci bilaterally, and in unilateral loci not used by acupuncturists for weight loss. No undesirable effects were noted. No treatment was associated with weight reduction significant at the 0.05 confidence level. A study involving guinea pigs was run parallel with the above clinical protocol and also demonstrated no effect of ear acupuncture on weight loss.
Acupuncture Therapy↗
Staging of pediatric cancers: problems in the development of a national system.
The majority of the common pediatric cancers are managed on clinical protocols and are treated in pediatric oncology centers. For this reason these neoplasms are being staged by a variety of protocols depending on the protocol study. Examples of the evaluation and currently used staging systems for Wilms' tumor, neuroblastoma, and rhabdomyosarcoma are presented. The goal is to develop a nationally accepted staging system for these common pediatric tumors that is broadly accepted for treatment planning, determining prognosis, and comparing institutional end results. It is obvious that, if a nationally accepted staging system is to evolve, the leadership of the existing national clinic research trials must be part of the process.
Adrenal Gland Neoplasms↗
Accumulation modes of alkylating agents on normal peripheral blood lymphocytes.
The in vitro uptake by normal peripheral blood lymphocytes of 14C-labeled cyclophosphamide and nitrogen mustard has been measured in a manner which parallels cell exposure to drugs used in the nitrogen mustard-oncovin-procabazine-prednisone (MOPP) and cyclophosphamide-oncovin-procarbazine-prednisone (COPP) clinical protocols. Accumulation of these alkylating agents occurs in two recognizable patterns. The first exhibits a saturation phenomenon, since radioactivity can be partially blocked by an equal concentration of unlabelled drug, reflects stereospecificity, and represents a minor fraction of total deposition. The second form, proportionately larger than the first, is dependent on drug concentration in the suspending medium, with radioactivity increasing in an apparently limitless linear fashion, uninfluenced by competitive inhibition. This part also is less tenaciously held by the lymphocyte. While the mere presence of drug on the lymphocytes does not necessarily imply injury or lethality, the fact that these peripheral lymphocytes are able to accumulate cytotoxic agents and are partially interchangeable with an analogous fixed lymphoid cell mass suggests that clinical immunosuppression and lymphocytopenia may be related, in part, to cell drug deposition.
Cyclophosphamide↗
New concept in activity-controlled pacemakers: clinical results with an accelerometer-based rate adaptive pacing system.
An accelerometer-based rate adaptive generator (EXCEL VR) has been introduced. A preclinical group of 22 subjects with strap-on devices was observed and reported. A clinical protocol including observation of rate adaptive response to typical daily activities and incremental exercise on a treadmill was administered in seven implanted patients. Indications for implantation in these patients was either second- or third-degree atrioventricular block (five patients, VVIR pacing mode) and sick sinus syndrome (two patients, AAIR pacing mode). Mean pacing rates were 50 ppm (supine), 56 ppm (standing), 77 ppm (descending the stairs), 81 ppm (slow walk), 83 ppm (slow stair climb), 91 ppm (fast walk), and 92 ppm (fast stair climb). When the arm proximal to the pulse generator was exercised, the rate rose to 92 ppm. When the distal arm was strained, the rate was 63 ppm. During treadmill testing, rates between 82 ppm (2 km/hour) and 104 ppm (5 km/hour) were observed. This accelerometer-based rate adaptive pulse generator provided a proportional response to graded activities of treadmill exercise and daily living in these groups of preclinical and clinical subjects.
Acceleration↗