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The doctor as focus group moderator--shifting roles and negotiating positions in health research.

BACKGROUND: Any research is inextricably entwined with the researcher's positions adopted while collecting data. This represents an important challenge to focus group moderators whose positions within the group influence data collection. This situation is particularly important in health research where moderators are doctors. OBJECTIVES: This study explores the moderator's social interaction with the group, in particular the moderator's position and how it affects data collection, the research process and knowledge production. METHODS: A qualitative study exploring group dynamics and the moderator's positions in focus group discussions, in particular the interaction between the moderator's position and her role as a doctor. RESULTS: The social construction and negotiation of the doctor's position depended both on the participants' view of the moderator and on the moderator's situational response. The moderator dealt with the participants' expectations and alternated between different positions: those she chose for herself and those chosen for her by the participants. Adoption of an active strategy outlining the moderator's position clarified the framework of data collection. CONCLUSIONS: Doctors using focus groups as research tool to gain insight into people's ideas about illness must be conscious about how their medical background influences their positions during data collection. The focus group moderator must balance between letting participants discuss the topics without being disturbed and actively intervening in the discussion to clarify the process. The researcher has to set the boundaries and guidelines as to how the research is conducted.

Female↗

Lessons learned as a research assistant studying ambulatory blood pressure in elderly Japanese stroke patients.

The research assistant plays a critical part in research projects, yet there is little structured information about the role. The present paper describes the research assistant"s role and provides an example of the research assistant"s activities in nursing research. In this pilot study, 24 h ambulatory blood pressure monitoring was conducted on 15 elderly Japanese stroke patients in a hospital rehabilitation unit. The research assistant's involvement is described along the course of the study: pre-data collection; data collection and data processing. A research assistant needs to have good communication skills, a detail-oriented focus and an inquisitive nature.

Aged↗

Feasibility and compliance of automated measurement of quality of life in oncology practice.

PURPOSE: Systematic quality-of-life (QOL) assessment may have value in oncology practice by increasing awareness of a wide range of issues, possibly increasing detection of psychologic morbidity, social problems, and changes in physical status, and improving care and its outcomes. However, logistic problems are substantial. Automated systems solve many of these problems. We field-tested the feasibility and compliance that can be achieved using a computer touchscreen system in two consecutive studies. PATIENTS AND METHODS: In study 1, a prospective cohort of 272 patients was offered QOL assessment at each clinic appointment for 6 months. In study 2, all patients (N = 1,291) were offered QOL assessment as part of clinic routine during a 12-week period. RESULTS: In study 1, 82% of patients agreed to take part, but over time, compliance was poor (median, 40%; mean, 43%) and deteriorated with longer follow-up. In study 2, the overall compliance was greatly increased (median, 100%; mean, 70%), and compliance was retained over multiple visits. In study 1, compliance was better in younger patients, males, and socially advantaged patients, but was not affected by the presence of depression or anxiety, or QOL. In the second study, building on experience in the first study, data collection and storage in the computer system was excellent, achieving 98% of collected data stored in one center. In general, patients were comfortable with the computers and the approach. Data collection on the wards was more difficult and less complete than in clinics, especially for patients undergoing acute admissions. CONCLUSION: Feasibility with higher compliance was demonstrated in study 2, in which the data collection was integrated into routine care, and can be improved with further technical initiatives and education of staff.

Adult↗

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↗

Collection of data in clinical studies via Internet.

This paper describes a system enabling data collection in multicenter clinical trials via WWW and Internet. The form-based data entry is based on HTML documents with JavaScript linked to a relational database (mSQL) via a cgi program (w3-msql). The design has been applied to a multi-national study in acute abdominal pain, for which eight clinical forms have been developed. The system is now in test use and experiences with this approach are presented.

Abdominal Pain↗

Accuracy of routinely collected clinical data on acute medical admissions to one hospital.

Despite the rapid growth in routine computerized data collection within the National Health Service (NHS), and the increased use of such data for generating hospital statistics and doctor activity rates, few validation studies exist. During a study of 158 acute medical admissions, and examination of hospital data revealed numerous and systematic inaccuracies. If general practitioner (GP) performance statistics are to be reliably based on such sources, data validation, staff training, and protocols for data entry should form a routine part of NHS practice.

Acute Disease↗

The quality of routinely collected maternity data.

OBJECTIVE: To assess the validity of clinical information held on a regional maternity database, the St Mary's Maternity Information System (SMMIS). DESIGN: A retrospective review of 892 maternity case notes and matched SMMIS records, by a midwife trained in clinical coding techniques. SETTING: Three maternity units in the North West Thames Region. MAIN OUTCOME MEASURES: Percentage agreement for 17 directly recorded SMMIS data items and equivalent data abstracted from the notes. Frequencies of diagnosis codes abstracted from case notes, as compared with those generated by SMMIS on the basis of directly recorded data. RESULTS: A generally high level of agreement was observed between the abstracts of the notes and the SMMIS records. Of the 17 data items examined, 10 showed 95% agreement or better, and all but two exceeded 80% agreement. Little difference was found between the levels of agreement observed at the three sites. A greater number and range of diagnosis codes were abstracted from the notes than were generated by SMMIS. CONCLUSIONS: The directly recorded clinical data held on the SMMIS regional database is largely accurate and consistently recorded across a variety of units. The database can therefore be considered a valuable resource for the comparative audit of maternity practice. The SMMIS technique for deriving, on a semi-automatic basis, diagnosis codes from the directly recorded fields, appears to work moderately well. We suggest that the direct method of data collection used in SMMIS could provide a model for other specialties in the National Health Service.

Data Collection↗

Collecting sensitive data: the impact on researchers.

The authors undertook an exploratory study to identify issues that arose for researchers while conducting fieldwork. Ten researchers engaged in "sensitive" inquiry were purposefully sampled and encouraged to talk about their experiences during the data collection process. Interviews were transcribed and common themes identified. The findings indicate that these researchers experienced a number of difficulties that centered around issues of lack of training, confidentiality, role conflict, costs to the participants, the desire for reciprocity, and feelings of isolation. The authors discuss the implications of the findings, including the need for support for researchers for further research.

Acquired Immunodeficiency Syndrome↗

Chronobiology in 1975.

UNLABELLED: A spectrum of rhythms with several frequencies importantly characterizes not only the central nervous system but also the neuroendocrines and endocrines, other structures and organs, beyond the level of the cell to subcellular structures; it has a wide bearing since chronobiologic methods and facts relate to both basic research and its bearing on major problems of our day. Perhaps most important, computer analysis of data series allows study of temporal structure, progressive and rhythmic variations in life processes and in their responses to environment and drugs. By such methods coupled to modern data collection and/or self-measurement, chronobiology is particularly promising in the following areas, cited as illustrative rather than comprehensive examples: 1. Work hygiene: optimization of work schedules by adjustment of regular schedules and in particular of shift-work to the individuals' physical and mental rhythms. Experimentally, differences in manner of schedule change can account for the difference between the life span shortening and lengthening. 2. Population control: improved methods for detecting the neural as well as neurohormonal regulation of ovulatory cycles should aid efficient family planning by the recognition of a spectrum of rhythms and its synchronization with socio-ecologic factors acting, perhaps, via olfactory and/or other sensory modalities; 3. Nutrition: optimizing the utilization of ever scarcer food supplies and also the benefit from both oral and parenteral medications by meal timing; 4. Education: providing a do-it-yourself system for monitoring individual health in the context of secondary and adult education and as the basis for preventive health care; and, in another context, taking individual mental rhythms as well as morningness-eveningness into account in teaching and learning; 5. Health care: Any risk, e.g., from blood pressure rhythm alteration (perhaps preceding by years intermittent labile elevation) will be detected earlier and more efficiently by multiple measurements readily obtained by autorhythmometry. Results of such an endeavor provide at any one time indices that can be compared with an individualized rhythmometric reference standard as well as peer group rhythm parameters. The rhythm-determined average is more reliable than the single measurement. Other individualized characteristics of a rhythm, such as measures of extent of change or timing of change, may constitute an early warning signal and could be monitored by self-measured or preferably automatically-collected data. Timely and timed treatment can then be sought to prevent, in the case of blood pressure, elevation and consequent debilitating disease such as coronary infarction and stroke. 6. THERAPY: One can strive toward the more specific correction of any pathogenic rhythm alteration when such can be recognized by modern methods of data collection and data analysis...

Animals↗

The automatic lung parameter estimator (ALPE) system: non-invasive estimation of pulmonary gas exchange parameters in 10-15 minutes.

OBJECTIVE: Clinical measurements of pulmonary gas exchange abnormalities might help prevent hypoxaemia and be useful in monitoring the effects of therapy. In clinical practice single parameters are often used to describe the abnormality e.g., the "effective shunt." A single parameter description is often insufficient, lumping the effects of several abnormalities. A more detailed picture can be obtained from experiments where FiO2 is varied and two parameters estimated. These experiments have previously taken 30-40 minutes to complete, making them inappropriate for routine clinical use. However with automation of data collection and parameter estimation, the experimental time can be reduced to 10-15 minutes. METHODS: A system has been built for non-invasive, Automatic, Lung Parameter Estimation (ALPE). This system consists of a ventilator, a gas analyser with pulse oximeter, and a computer. Computer programs control the experimental procedure, collect data from the ventilator and gas analyser, and estimate pulmonary gas exchange parameters. Use of the ALPE system, i.e. in estimating gas exchange parameters and reducing experimental time, has been tested on five normal subjects, two patients before and during diuretic therapy, and on 50 occasions in patients before and after surgical intervention. RESULTS: The ALPE system provides estimation of pulmonary gas exchange parameters from a simple, clinical, non-invasive procedure, automatically and quickly. For normal subjects and in patients receiving diuretic therapy, data collection by clinicians familiar with ALPE took (mean +/- SD) 13 min 40 sec +/- 1 min 23 sec. For studies on patients before and after surgery, data collection by an intensive care nurse took (mean +/- SD) 10 min 47 sec +/- 2 min 14 sec. Parameter estimates were: for normal subjects, shunt = 4.95% +/- 2.64% and fA2 = 0.89 +/- 0.01; for patients with heart failure prior to diuretic therapy, patient 1, shunt = 11.50% fA2 = 0.41, patient 2 shunt = 11.61% fA2 = 0.55; and during therapy: patient 1, shunt = 11.51% fA2 = 0.71, patient 2, shunt = 11.22% fA2 = 0.49. CONCLUSIONS: The ALPE system provides quick, non-invasive estimation of pulmonary gas exchange parameters and may have several clinical applications. These include, monitoring pulmonary gas exchange abnormalities in the ICU, assessing post-operative gas exchange abnormalities, and titrating diuretic therapy in patients with heart failure.

Diuretics↗

[Care required by disabled persons: are official severe disability statistics good enough for requirement analyses?].

The appropriateness of the German Official Severe Disability Statistics for determining the amount of care needed by disabled persons is a controversial issue and therefore in the focus of this article. The criteria for determining the care required by disabled persons are pointed out. Data on prevalence and incidence exemplify that Official Severe Disability Statistics is only partially appropriate for assessing future care requirements. The problems become particularly obvious in topics of data collection, data processing and data storage. The deletion of the statistical data at regular intervals of five years makes long term prognosis almost impossible. While the problems concerning data processing and data storage could be solved by few modifications, the improvement of data collection could only be achieved by including and applying the International Classification of Functioning (ICF) of the WHO.

Activities of Daily Living↗

The prophylactic clinical trial as a epidemiologic resource.

We encourage investigators to use data collected in a clinical trial of a prophylactic agent or procedure to study the epidemiology of the disease or event the prophylactic was meant to prevent. Making additional use of previously collected data is economically attractive. Problems can arise, however, if the sample is not representative of the universe of all people at risk of the disorder, the data set is not adequate to the task, or the prophylactic and/or its correlates influence the risk of the disorder. Investigators should consider modifying data collection procedures in future prophylactic trials so that they are suitable for an epidemiologic study. They and readers of their reports, however, are advised to be cautious in drawing inferences from epidemiologic studies extracted from prophylactic trials.

Clinical Trials as Topic↗

Improving hospital-acquired infection rates: the CDC experience.

BACKGROUND: The National Nosocomial Infections Surveillance (NNIS) System, begun in 1970 by the Centers for Disease Control to collect data on hospital-acquired infections, is one of the oldest continuously operating clinical performance indicator systems in the United States. Growth of the system, from 19 to 230 hospitals, has been accompanied by developments such as the evolution from hospitalwide to targeted surveillance, improved data processing and telecommunications for data collection and reporting, and risk adjustment. ELEMENTS OF A SUCCESSFUL SYSTEM: The NNIS System provides specific, standardized methods for data collection and uses device-associated, device-day rates to risk adjust the data and make it meaningful for interhospital comparison. The system has been used as a tool for improving quality of care through prevention of nosocomial infections. For example, an 800-bed teaching hospital's rate of ventilator-associated nosocomial pneumonia in the surgical intensive care unit-49.5 infections per 1,000 ventilator days-was in excess of the 90th percentile. Improvements in care, including changing tubing and cascades every 48 hours and Ambu bags every 24 hours, as well as increased clinical evaluation of patients, was followed 12 months later by a decrease to 25.8 infections, well below the 90th percentile. INFORMATION DISSEMINATION: Since 1992, staff from NNIS hospitals have met in a biennial conference to learn about advances in nosocomial infection surveillance and to share information with one another on infection control and quality improvement programs. CONCLUSIONS: The NNIS experience can be used as a source of guidance for assessing the effectiveness and utility of other indicator systems.

Adult↗

[Determining the possibility of collecting reliable data for use in decision making in health care on the example of cost-effectiveness analysis of methods used in smoking cessation].

Reports on Polish Health care system found that the evidence from systematic reviews and cost-effectiveness analyses is not sufficiently used in decision-making. The aim of this study was to determine the possibility of reliable cost and other data collection in Poland to inform cost-effectiveness analysis of smoking cessation methods in Poland, which could be used to support decisions from the perspective of National Health Fund. In order to estimate long term effects of smoking cessation Markov model was built. Direct medical costs of the following smoking related diseases were sought: chronic obstructive pulmonary disease, coronary heart disease, lung cancer and stroke. Analysis was performed from National Health Fund perspective. Published cost data were insufficient for the analysis, so an attempt was made to obtain cost data from National Insurance Fund, which was not very successful due to their lack. Mortality data were obtained from National Office of Statistics. Lung cancer incidence and mortality were obtained from national register. No registries systematically and routinely collecting incidence and prevalence data for other diseases were localized. No studies exploring utilities of Polish population in the analyzed health states were found. As no disease registries, except for cancer, systematically collecting epidemiologic data and no unified system of collecting cost data were found, less reliable data has to be used in cost-effectiveness analyses supporting the decisions in health care in Poland.

Cost of Illness↗

Medical audit data: counting is not enough.

OBJECTIVE: To assess the meaningfulness of a year's worth of audit data relating to all the inpatients of one consultant general surgeon and to question the usefulness of certain outcome measures. DESIGN: Analysis of records entered on to audit computer (Dunnfile) and relating to inpatient episodes for one consultant general surgeon over one year. Data obtained were compared with ward records and the patient administration system to check their accuracy. SETTING: The three hospitals and 12 wards in Brighton health district where the surgeon admitted patients. SUBJECTS: 859 Records relating to inpatient episodes from 1 January to 31 December 1988. These covered 655 main procedures and 79 secondary procedures performed at the same time. MAIN OUTCOME MEASURES: Procedures were analysed by complexity of operation (BUPA code) and grade of surgeon; complications were counted and rates constructed by surgeon and by BUPA code: returns to theatre were analysed. RESULTS: Simple counts revealed some data, such as the fact that one registrar performed more major operations (32) than the senior registrars (22 and 14), and an analysis of complications showed that he had a lower complication rate (11.4% v 20.0% and 19.4%). But the simple complication rate disclosed nothing about whether the complication was avoidable. Likewise, the number of returns to theatre needed further qualification. Analysis of data collection for February to April 1988 showed a 30% deficit of information on the audit system compared with ward records and prompted a re-examination of everyone's role in collecting data. After the year's audit there was still a 17% shortfall compared with the district's patient administration system, though some of this was accounted for by a backlog of work. CONCLUSIONS: It is difficult to ensure adequate data collection and entails everyone in an unfamiliar discipline. Connecting the audit system to the patient administration system would help. Despite the limitations of crude analyses of workload and complications rates, the audit data helped to measure activity and in the management of the firm. Nevertheless, time and care have to be taken in presenting and interpreting audit data carefully. IMPLICATIONS: Counting is not enough.

Aged↗

Sampling density compensation in MRI: rationale and an iterative numerical solution.

Data collection of MRI which is sampled nonuniformly in k-space is often interpolated onto a Cartesian grid for fast reconstruction. The collected data must be properly weighted before interpolation, for accurate reconstruction. We propose a criterion for choosing the weighting function necessary to compensate for nonuniform sampling density. A numerical iterative method to find a weighting function that meets that criterion is also given. This method uses only the coordinates of the sampled data; unlike previous methods, it does not require knowledge of the trajectories and can easily handle trajectories that "cross" in k-space. Moreover, the method can handle sampling patterns that are undersampled in some regions of k-space and does not require a post-gridding density correction. Weighting functions for various data collection strategies are shown. Synthesized and collected in vivo data also illustrate aspects of this method.

Anisotropy↗

Parent behavioral training: an analysis of the relationship among multiple outcome measures.

The purpose of the present study was to examine the relationship among three types of outcome measures that have been employed to evaluate parent behavioral trainining: observational data collected by independent observers, parent-collected data, and parent-completed questionnaires. Previous research suggests that all three measures yield positive outcome data; however, a correlational analysis has not been performed to determine if the subjects who demonstrate the largest (smallest) change on one measure demonstrate the largest (smallest) change on the other measures. The present study undertook such a correlational analysis. Subjects were 20 young clinic-referred children and their mothers. Treatment consisted of a standardized parent training program to modify child noncompliance. All three outcome measures (observational data, parent-collected data, and questionnaire data) indicated that therapy was effective. A correlational analysis performed on the outcome measures indicated a number of significant relationships for dependent variables within the observational data and within the questionnaire data; however, there were no significant relationships across the three outcome measures. Although different outcome measures may yield similar conclusions about the effectiveness of parent behavioral training, the results suggest that any one subject, relative to other subjects, does not demonstrate uniform degrees of change across the three outcome measures. Explanations for the findings, as well as their implications, are discussed.

Behavior Therapy↗

Procedures performed by pediatric transport nurses: how "advanced" is the practice?

INTRODUCTION: Pediatric interfacility transport teams often rely on advanced practice nurses as primary care providers. These individuals may be required to transport patients without the presence of a physician. There is, however, little information in the medical literature regarding how frequently advanced practice transport nurses perform advanced procedures, how often these procedures are successfully performed, and the rate of complications associated with nurse-performed procedures. PURPOSE: The purpose of this study was to determine how frequently advanced practice transport nurses were called on to perform advanced procedures and to determine the nurses' procedural success and complication rates. DESIGN: Prospective convenience sample of consecutive pediatric interfacility transports. METHODS: Transport nurses collected data on 336 pediatric interfacility transports that were performed during a 4-month period beginning in May 1997. All patient transports occurring during the study period were included. Data regarding procedures were recorded on data collection sheets. This data included the type of procedure performed, the outcome of the procedure, and the complications associated with the procedure. The number of attempts required to successfully complete the procedure was not recorded. During or after the patient's hospitalization, the medical record was reviewed to identify potential complications related to the transport that may not have been recorded on the data collection sheet. RESULTS: Nurses performed 95.2% of transports without the presence of a physician. Twenty-six patients (8.8%) required advanced procedures. Nurses performed eight tracheal intubations. Personnel at the referring hospital performed the remaining procedures. All tracheal intubations by transport nurses were successful. There were no complications related to these procedures. All patients were transported to the receiving hospital without incident. CONCLUSIONS: Although they had considerable training for advanced procedures, the transport nurses rarely used these skills. All tracheal intubations performed by transport nurses were successful, and there were no adverse consequences related to intubation by a transport nurse.

Ambulances↗