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At least 217 records · Page 12Linked to original sources
PubMed2000

Knowledge representation and tool support for critiquing clinical trial protocols.

The increasing complexities of clinical trials have led to increasing costs for investigators and organizations that author and administer those trials. The process of authoring a clinical trial protocol, the document that specifies the details of the study, is usually a manual task, and thus authors may introduce subtle errors in medical and procedural content. We have created a protocol inspection and critiquing tool (PICASSO) that evaluates the procedural aspects of a clinical trial protocol. To implement this tool, we developed a knowledge base for clinical trials that contains knowledge of the medical domain (diseases, drugs, lab tests, etc.) and of specific requirements for clinical trial protocols (eligibility criteria, patient treatments, and monitoring activities). We also developed a set of constraints, expressed in a formal language, that describe appropriate practices for authoring clinical trials. If a clinical trial designed with PICASSO violates any of these constraints, PICASSO generates a message to the user and a list of inconsistencies for each violated constraint. To test our methodology, we encoded portions of a hypothetical protocol and implemented designs consistent and inconsistent with known clinical trial practice. Our hope is that this methodology will be useful for standardizing new protocols and improving their quality.

Artificial Intelligence↗
PubMedDate not supplied

[Morbid obesity. Reflections on a surgical protocol (I). A clinical and peroperative protocol].

UNLABELLED: Obesity as a condition, and morbid obesity as a disease, have at present reached epidemic proportions. Bariatric surgery is the most effective treatment in those patients in whom medical, dietary, and/or behavioral treatments have failed. What is more, it is the initial treatment of choice in morbid superobese patients (> 50 kg/m2). The present study summarizes and criticizes the main surgical techniques used at present, and purposes an action protocol for anesthesia, as well as some norms and advice on control, action, and pulmonary and dietary rehabilitation, in the peri- and post operative period, based on more than 7 years' experience with a series of more than 150 operated and controlled patients. CONCLUSION: A restrictive bariatric technique is a model which allows the multidisciplinary obesity treatment team to achieve a definite and permanent modification of the eating habits of all patients who meet the criteria for inclusion in a surgical protocol.

Anesthesia↗
PubMed2005

The use of high-fidelity human patient simulation as an evaluative tool in the development of clinical research protocols and procedures.

Errors in clinical research can be costly, in terms of patient safety, data integrity, and data collection. Data inaccuracy in early subjects of a clinical study may be associated with problems in the design of the protocol, procedures, and data collection tools. High-fidelity patient simulation centers provide an ideal environment to apply human-centered design to clinical trial development. A draft of a complex clinical protocol was designed, evaluated and modified using a high-fidelity human patient simulator in the Duke University Human Simulation and Patient Safety Center. The process included walk-throughs, detailed modifications of the protocol and development of procedural aids. Training of monitors and coordinators provided an opportunity for observation of performance that was used to identify further improvements to the protocol. Evaluative steps were used to design the research protocol and procedures. Iterative modifications were made to the protocol and data collection tools. The success in use of human simulation in the preparation of a complex clinical drug trial suggests the benefits of human patient simulation extend beyond training and medical equipment evaluation. Human patient simulation can provide a context for informal expert evaluation of clinical protocol design and for formal "rehearsal" to evaluate the efficacy of procedures and support tools.

Clinical Competence↗
PubMed2002

Effect of an imaging protocol on clinical outcomes among pediatric patients with appendicitis.

OBJECTIVE: In 1998, we implemented a clinical imaging protocol in which children with suspected appendicitis underwent ultrasonography (US) followed by computed tomography (CT). We sought to determine the impact of the US-CT protocol on changes in perforation and negative appendectomy rates. METHODS: Children with unequivocal presentations for appendicitis went to the operating room without entering the imaging protocol. Using a modified time series design, we analyzed a prospective and retrospective cohort of consecutive patients who were admitted from the emergency department for suspected appendicitis. The perforation and negative appendectomy rates were computed for the periods before and after implementation of the imaging protocol and adjustment for time trends was made. RESULTS: A total of 1338 children were identified. Eight hundred ten (60.5%) children had equivocal clinical findings. A total of 920 patients were admitted for suspected appendicitis before the protocol was implemented; 526 (57.2%) of the 920 children had appendicitis, and 186 (35.4%) of them had perforation. A total of 91 (14.7%) of 617 had negative appendectomies. After the protocol was implemented, 418 patients were admitted for suspected appendicitis; 328 (78.5%) had appendicitis with 51 (15.5%) perforated. There were 14 (4.1%) of 342 cases of negative appendectomies. After implementation of the imaging protocol, the perforation rate decreased from 35.4% to 15.5%, and the negative appendectomy rate decreased from 14.7% to 4.1%. After secular time trends were adjusted for, the imaging protocol continued to have a strong association with a reduction in perforation rate and negative appendectomy rate. CONCLUSION: The implementation of an imaging protocol using US and CT resulted in a marked decrease in the perforation and negative appendectomy rates in children with suspected appendicitis.

Adolescent↗
PubMed1999

[The evaluation of the structural quality of clinical physiotherapy protocols produced in primary care. Members of the Protocol Evaluation Team].

OBJECTIVE: To evaluate the quality of the design (structural) of the clinical protocols elaborated in all the health centers, ambulatory or consulting of Spain with protocolized physical therapy activities. DESIGN: Observational retrospective study lasting 7 years. SETTING: Primary care of health. PARTICIPATING: All the clinical physical therapy protocols elaborated from 1990 to 1997. MEASUREMENTS: They are elaborated 8 criteria of quality of the design of the protocols. Assessment of the reliability inter-rather of those criteria, adding explanations to two of they. It is proceeded to the evaluation of the quality of the design of 158 gathered protocols, being obtained the number from nonfulfillments. RESULTS: Compliance of the criteria: 49.36% (78) have record system. 32.91% (52) have anticipated their/its/your/his evaluation. 20.88% (33) have some algorithm. 38.6% (61) have page of history and/or specific exploration. 96.83% (153) have a minor extension of 20 pages. Only 22.15% (35) have index. 36.7% (58) do not have formal writing defects and legibility and 22.7% (36) provide bibliography. Only one of the eight criteria is complianced in more than 50% of the protocols; it being fulfilled in less than 30% other three. By and large the clinical protocols present a total of 758 defects, with a defects average by protocol of 5.24 (0 defects in a case). CONCLUSIONS: The structural quality of the clinical physical therapy protocols elaborated in primary attention until 1997 is decreases (globally fulfil 40.03% of the proposed criteria). The decrease quality of the protocols is significantly heterogeneous between the autonomous community and the elaboration years. They are necessary corrective measures to improve this situation.

Clinical Protocols↗
PubMed1984

Errors in predicting functional capacity for postmyocardial infarction patients using a modified Bruce protocol.

Clinically, the modified Bruce protocol is widely used to predict functional capacity in postmyocardial infarction (post-MI) patients. However, it has been suggested that post-MI patients have lower oxygen uptakes for standard workloads. In order to study this, we measured oxygen uptake (VO2) and venous blood lactic acid concentration in 12 post-MI patients and 12 normal male subjects during a modified Bruce treadmill protocol. During the first four stages of the protocol, mean oxygen uptake was significantly lower (1.0 to 6.2 cc X kg-1 X min-1; p less than 0.001) for the post-MI patients than for the normal male subjects. Venous blood lactic acid concentrations were different only at stage 4. However, a higher respiratory exchange ratio was observed for post-MI patients (p less than 0.001 at stage 3), suggesting an increased anaerobic metabolism and adequate buffering of lactic acid. The post-MI patient's measured VO2 for three stages of the protocol ranged from 1.8 to 7.3 cc X kg-1 X min-1 lower than the Bruce prediction for cardiac patients. In addition, maximal measured VO2 for the post-MI patients ranged from 3.7 to 11.2 cc X kg-1 X min-1 lower than predicted VO2 derived from the normal subjects. These data suggest myocardial damage may slow oxygen uptake kinetics, thus increasing the oxygen deficit at standard workloads during progressive exercise. An increased respiratory exchange ratio secondary to the buffering of lactic acid suggests that anaerobic metabolism may compensate for this oxygen deficit.

Coronary Disease↗
PubMedDate not supplied

[Clinical management in an angiology and vascular surgery unit. Results of the application of a clinical practice protocols].

OBJECTIVES: The aim of this study was to analyze the impact of clinical management on quality indicators in a vascular surgery unit over a 10-year period. METHODS: We performed a retrospective analysis of quality indicators from 1990 to 2001 and of the influence of a clinical practice protocol and standards of quality on these indicators. RESULTS: Comparison of both periods revealed improvement in all the quality indicators. The safety of surgical procedures was unaffected by the application of management protocols and clinical pathways. CONCLUSIONS: Clinical management based on the cost-quality binomial can ensure the efficiency of a hospital unit without adversely affecting quality of care. Quality standards based on hospital resource use, morbidity and mortality can be defined for groups of procedures.

Algorithms↗
PubMed2004

A collaborative clinical trial protocol writing system.

Increasing complexity in medicine has caused clinical trial experts with disparate backgrounds from multiple organizations to collaborate when developing clinical trial protocols. Although many protocol-authoring tools provide computerbased decision support to assist in protocol writing, few of them provide sufficient collaboration support for a group of protocol writers. The iterative group writing activities among interdisciplinary clinical trial experts call for advanced tool support. Here we present a web-based protocol writing system with integrated support for collaborative reviewing and collaborative editing. The system uses a shared database to store threaded review comments and version information for electronic protocols. It also captures rich group event information to provide cross-activity awareness and to facilitate self-coordination within the collaborative writing team. We believe that our system can help streamline collaborative clinical trial protocol writing processes.

Clinical Protocols↗
PubMed1975

Biomaterials science protocols for clinical investigations on porous alumina ceramic and vitreous carbon implants.

A written protocol for the investigation of candidate surgical implant materials is quite important. Biomaterials science sections of clinical protocols have been developed for porous alumina ceramic and nonporous vitreous carbon biomaterials. Published data on the properties of the biomaterials were evaluated as related to bone replacement and augmentation. Where necessary, limited laboratory studies were conducted. If decisions could not be reached with respect to a given application, animal studies were initiated. The surgeons worked with biomaterials in the laboratory and the biomaterials scientist attended the experimental surgery procedures. Biomaterials Science Laboratory nondestructive investigations including stereomicroscopic and x-ray inspections were conducted on the vitreous carbon dental implant systems. The investigations elucidated a number of unexpected features for both implant biomaterials and the overall interaction between the different disciplines resulted in a more complete protocol for the study of these biomaterials at our Medical and Dental Center.

Aluminum↗
PubMed1993

Evaluation of the methodological quality of clinical trial protocols. A preliminary experience in Spain.

The methodological quality of 50 clinical trial protocols submitted to our hospital has been assessed by means of a check-list. The most frequent methodological deficiencies found were related to statistical analysis, selection criteria, sample size, incorrect use of placebo, homogeneity of the groups, concomitant medication, randomisation plan, monitoring of adverse events and study design. Lack of insurance for the patients and inadequacies in the investigators' brochure and case report forms were observed in a significant number of cases. The results suggest the importance of a multidisciplinary team in the elaboration of clinical trial protocols to prevent methodological errors.

Clinical Protocols↗
PubMed2006

Quantitative sensory testing: a comprehensive protocol for clinical trials.

We have compiled a comprehensive QST protocol as part of the German Research Network on Neuropathic Pain (DFNS) using well established tests for nearly all aspects of somatosensation. This protocol encompasses thermal as well as mechanical testing procedures. Our rationale was to test for patterns of sensory loss (small and large nerve fiber functions) or gain (hyperalgesia, allodynia, hyperpathia), and to assess both cutaneous and deep pain sensitivity. The practicality of the QST protocol was tested in 18 healthy subjects, 21-58 years, half of them female. All subjects were tested bilaterally over face, hand and foot. We determined thermal detection and pain thresholds including a test for the presence of paradoxical heat sensations, mechanical detection thresholds to von Frey filaments and a 64-Hz tuning fork, mechanical pain thresholds to pinprick stimuli and blunt pressure, stimulus-response-functions for pinprick and dynamic mechanical allodynia (pain to light touch), and pain summation (wind-up ratio) using repetitive pinprick stimulation. The full protocol took 27+/-2.3 min per test area. The majority of QST parameters were normally distributed only after logarithmic transformation (secondary normalization) except for the frequency of paradoxical heat sensations, cold and heat pain thresholds, and for vibration detection thresholds. Thresholds were usually lowest over face, followed by hand, and then foot. Only thermal pain thresholds, wind-up ratio and vibration detection thresholds were not significantly dependent on the body region. There was no significant right-to-left difference for any of the QST parameters; left-to-right correlation coefficients ranged between 0.78 and 0.97, thus explaining between 61% and 94% of the variance. This study has shown that a complete somatosensory profile of one affected area and one unaffected control area, which will be necessary to characterize patients with a variety of diseases, can be obtained within 1 h. Case examples of selected patients illustrate the value of z-transformed QST data for an easy survey of individual symptom profiles.

Adult↗
PubMed2004

Heterogeneous planning for homogeneous protocols.

Clinical trials often require homogeneous treatment plans. Many institutions, however, have begun using heterogeneous plans. Is it possible to satisfy the requirements of such a protocol while achieving the superior accuracy of heterogeneous treatment planning? At the University of Texas M. D. Anderson Cancer Center, we currently use conformal treatment planning with heterogeneities for thoracic cancers. This paper describes a procedure that has been developed to satisfy the requirements of a homogeneous protocol, such as RTOG 98-01 (A Phase III Study of Amifostine mucosal protection), while maintaining accuracy in treatment planning.

Amifostine↗