Biomedical subjects

A G DuChene

Publications and source records attributed to A G DuChene.

7 recordsLinked to original sources

PubMed1991

Pulmonary function in relation to cigarette smoking and smoking cessation. MRFIT Research Group.

BACKGROUND: More than half of the subjects in the MRFIT smoked at baseline and 10% of the subjects stopped smoking permanently during the first year of the trial. In this report, rates of decline in forced expiratory volume in 1 sec (FEV1) are compared for early permanent quitters and smokers who continued to smoke throughout the trial. METHODS: Since pulmonary function testing was not standardized across all centers until the third annual visit cycle, change in FEV1 is examined over the latter half of the trial; the level of FEV1 is analyzed cross-sectionally at the midpoint of the trial. Analyses are limited to 4,926 subjects who never used beta-blockers or smoked cigars, cigarillos, or pipes during the trial and who had annual FEV1s measured over 2-4 years in the latter half of the trial. RESULTS: Quitters during the first 12 months experienced smaller declines in FEV1 over the latter half of the trial than continuing smokers, with -50.7 ml/year versus -59.0 ml/year, respectively, adjusted for the level of FEV1 (P = 0.05). Cross-sectionally, those who had never smoked, former smokers, quitters, and continuing smokers showed a gradient of decreasing FEV1, and all four smoking groups were significantly different from each other (P less than 0.05). CONCLUSIONS: These data suggest that if a middle-aged, healthy smoker stopped smoking permanently, he could expect his FEV1 to deteriorate at a more gradual rate 3-4 years after stopping smoking than a similar smoker who continued to smoke. No information was available for the complete MRFIT cohort on the pulmonary function effects immediately following smoking cessation.

Adult↗

PubMed1986

Quality control of biochemical data in the Multiple Risk Factor Intervention Trial: Central Laboratory.

The acquisition of quality biochemical data in the MRFIT was enhanced by writing detailed protocols, instituting strict rules for collecting and shipping specimens, setting high goals for analytical performance, using reliable means to transfer data, employing dedicated and competent analysts, and having a director of the Central Laboratory who believed in and enforced an effective quality control system. A Laboratory Quality Control Subcommittee was formed to work with this director in solving laboratory problems, with the Coordinating Center in conducting appropriate monitoring, with the Quality Control Committee in documenting the quality of data and investigating any laboratory problems, and with other committees of the directors and Program Office in responding to any questions raised about laboratory aspects of the trial. All of these efforts culminated in reliable biochemical data.

Cholesterol↗

PubMed1986

Forms control and error detection procedures used at the Coordinating Center of the Multiple Risk Factor Intervention Trial (MRFIT).

Although methods used for data collection and quality assurance for large-scale clinical trials are important to critical reading of trial results and have been published, such reporting is the exception rather than the rule. In the MRFIT, systematic methods for processing large volumes of data over a long period of time were developed. The methods were designed to detect and control a variety of errors and to leave a complete audit trial of the processing of forms and corrections to forms. Many of these methods evolved and were refined during the course of the study as a result of trial and error. If one were to start over, the methods described herein would be modified. The field of data processing is evolving, and it is important for statistical and data processing staff of coordinating centers to recognize this and continually evaluate and update their methods. For example, the simultaneous entry and computer editing of forms is becoming more feasible with time. Also, more sophisticated intelligent data entry equipment is available for central use. Near the end of MRFIT, some data received at the Coordinating Center were entered and edited on a minicomputer. The parameter-driven edits described previously were performed at the time of data entry. Additional modifications to the content of the data dictionary for future studies are also being considered. The incorporation into the data dictionary of consistency checks (both deterministic and probabilistic) between fields on different forms would facilitate the specification of complex edit checks and would provide better documentation of the edit checks actually performed. Incorporating definitions of the numeric codes for each field would improve the documentation and facilitate reporting using statistical packages. Dedicated computer hardware should also be a major consideration of coordinating centers in future clinical trials. For MRFIT, a dedicated system was used from 1978 to the end of the trial. With the continued decline in hardware costs, dedicated systems can and should be considered, even for trials much smaller than MRFIT. We believe the system developed for processing data in the MRFIT has several advantages. It satisfies the requirements identified by Karrison or a system of data editing and control, it is largely self-documenting as a result of the data dictionary approach taken, and it is easily adaptable to other clinical studies.

Clinical Trials as Topic↗

PubMed1986

Quality control in the Multiple Risk Factor Intervention Trial Nutrition Modality.

One of the principal objectives of the MRFIT was to teach and motivate participants assigned to the SI group to adhere to a fat-controlled dietary regimen over the course of the trial. The magnitude of the trial (with more than 12,000 participants, half of them assigned to the SI protocol, to be followed for at least 6 years in 22 separate centers) presented new challenges for maintenance of quality control over a nutrition intervention program. Collection of data to monitor changes in dietary intake over time in SI and UC groups, as well as information to assess dietary adherence levels in SI participants also presented large-scale challenges in maintenance of quality control. The MRFIT formulated many of its initial nutrition intervention and data collection decisions based on experience of the earlier National Diet Heart Study (NDHS). In order to avoid coding 7-day dietary records by local clinic nutritionists (as in NDHS), the trial opted for collection of 24-hour dietary recalls that were coded centrally at the Nutrition Coding Center. It necessitated extra attention to training and certification of clinic nutritionist-interviewers to be certain that NCC coders had sufficiently precise information about all foods entered on dietary recall forms. Since dietary intake data were collected over a time span of approximately 10 years, procedures for updating the food composition database and coding rules were a necessity. Continuing attention to training and monitoring of performance of clinic nutritionist-interviewers also was important. The MRFIT nutrition intervention program was designed with the need for interclinic comparability of intervention techniques in mind. This required not only development of study-wide nutrition intervention materials, but also necessitated ongoing attention to staff training and monitoring procedures in order to ensure intercenter comparability of efforts. The success of the nutrition intervention modality depended upon the continuing efforts of the nutrition counselors not only to achieve dietary adherence but also to monitor levels of dietary adherence over time. The NDHS experience served as a springboard for designing the MRFIT nutrition intervention and data collection procedures. It is hoped that techniques for maintaining and monitoring quality control over the MRFIT nutrition modality as outlined in this chapter may prove useful to future planners.

Certification↗

PubMed1986

Quality control aspects of blood pressure measurements in the Multiple Risk Factor Intervention Trial.

Quality control of an ongoing study of blood pressure must be an active, dynamic process in which attempts are continually made to reduce error and bias and maintain comparability among clinics. Training is an important means of initiating and maintaining proper procedures. In addition, changes in procedures during the trial must be properly evaluated so that their impact upon the conduct of the trial is known and, if necessary, quantifiable. The monitoring of quality measurement of blood pressure in a large clinical trial such as MRFIT must be a two-pronged effort that considers observation and evaluation of methods of measuring blood pressure in actual clinical practice and evaluation of data resulting from these procedures.

Allied Health Personnel↗

PubMed1986

Quality control in the MRFIT local screening and clinic laboratory.

Quality control was emphasized in the screening and clinic laboratory during the early stages of the trial to cover all aspects of screening, and in the later stages to cover local testing used to monitor the participant in the clinic and to guarantee collection of valid specimens to be shipped to the Central Laboratory. Special attention throughout the trial was focused on techniques for collection of specimens, since it was recognized that analytical results could not be better than the quality of the specimens. Training courses, on-site visits, and newsletters were used to sensitize the staff of the clinic laboratory about the necessity to follow protocol. Any monitoring evidence of carelessness, use of deteriorated supplies, failure to follow safety rules, and deviation from directions in the MRFIT Manual of Operations resulted in memoranda from the Coordinating Center or the Central Laboratory.

Cholesterol↗

PubMed1986

Quality control aspects of pulmonary function testing in the Multiple Risk Factor Intervention Trial.

Pulmonary function testing was used in MRFIT to monitor the presence of airways disease and to assess changes in pulmonary function over time. The pulmonary function indices that were measured were FEV1, FVC, and MMEF, (FEF25-75). Quality control of technician training, equipment maintenance, data collection, and data measurement were essential to ensure that results, over time and from various clinics, could be compared. Based on the MRFIT experience, it is strongly recommended that centralized training in testing techniques and spirometer maintenance take place before a clinical trial begins, and periodically throughout a trial. Such training, combined with quality control follow-up, should prevent the loss of data due to inadequate spirometer maintenance and invalid testing procedures.

Allied Health Personnel↗