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Effect of computer software on time required to prepare parenteral nutrient solutions.

Pharmacist and technician times required for the preparation of parenteral nutrient (PN) solutions were studied before and after the introduction of a software package that is used with an automated compounder. At a 580-bed teaching hospital, work sampling was used to collect data on how time was spent by personnel in the i.v. admixture pharmacy during six-week periods before and after the introduction of software that calculates the quantities of PN solution ingredients on a computer-generated work sheet and prints labels. The second data-collection period began when the software had been in use for four months. In the second study period, there was a significant decrease (28%) in total pharmacist time spent per PN solution; the mean +/- S.D. pharmacist times per PN solution per day for the two study periods were 14.03 +/- 3.24 minutes and 10.12 +/- 1.61 minutes, respectively. There were also significant decreases in pharmacist time spent performing calculations, checking calculations, and typing labels. After introduction of the software, technicians spent significantly less time typing labels and pumping base solutions. Overall, technicians spent significantly less time per PN solution in the second study period (20.15 +/- 3.50 versus 17.82 +/- 1.94 minutes). Use of the software allowed pharmacist staffing in the i.v. admixture pharmacy to be reduced, and the pharmacy resources were reallocated toward the provision of clinical services. The generation of PN labels and calculation worksheets by computer software reduced pharmacist and technician time requirements for PN solution preparation.

Data Collection↗

Relationship between quantity of undergraduate science preparation and preclinical performance in medical school.

PURPOSE: The primary purpose of this study was to determine whether a relationship existed between the quantities of undergraduate science education completed by medical students and their subsequent preclinical performances in medical school. The secondary purpose of the study was to determine the nature of any relationship present and to re-verify standard predictors of preclinical performance in medical school. METHOD: This study was undertaken at Albany Medical College in conjunction with Sage Graduate School, Albany, New York. The analysis encompassed 120 systematically and 80 randomly selected medical student academic records (200 total cases) from the entering classes of 1977 through 1992. Twelve distinct variables were collected. Data transformations were completed as required, and the data subsequently standardized. Standard descriptive statistics, correlation between variables, t-tests between systematically and randomly selected groups, and factor analysis were performed on the data collected. RESULTS: It was determined that there was no significant relationship between total hours of undergraduate science completed and average preclinical performance in medical school. In addition, correlation between subdivisions of total hours of undergraduate science (total hours of chemistry, total hours of biology, total hours of math, and total hours of physics) and subdivisions of average preclinical performance (year-one preclinical performance and year-two preclinical performance) also proved to be nonsignificant. However, significant relationships between average preclinical performance and its subdivisions and other standard predictors of preclinical performance (Medical College Admission Test score and science grade-point average) were found to be in line with values in recent literature. In addition, significant relationships were found with the National Board of Medical Examiners Part I examination. Factor analysis of all variables yielded three underlying factors: medical school preclinical performance factor, undergraduate performance factor, and quantity of non-life-sciences factor. CONCLUSION: Quantity of science-based undergraduate premedical education, either in its entirety or in subdivisions, did not materially affect the performances of the selected medical school students in their preclinical years of medical school.

Achievement↗

Continuous improvement evaluation: a framework for multisite evaluation studies.

This article proposes the use of the continuous improvement evaluation (CIE), a framework for multisite demonstration or evaluation studies. This framework is designed for studying intervention programs that change during the evaluation. The development of family drug courts is provided as an example. CIE relies on outcome data collected over time and benchmarked across similar cases in comparison sites; thus, this study was designed to collect data on effectiveness of intervention programs at multiple sites and over time. A weight is calculated for similarity of any two cases based on features they share. In statistical process control charts, these weights are used to compare outcomes at the site against the average of similar cases in comparison groups. Once data are benchmarked, program staff meet to discuss process changes that have led to improvements in outcomes. To ensure that intervention programs have access to evaluation reports on demand, information technology is used to collect, clean, and pool data. Computers generate study reports, and evaluators review reports after release to clients. Statistical tools can be used to evaluate changing programs. Traditional evaluators may be concerned about some threats to validity associated with CIE. The article concludes with a discussion of typical threats to validity and how these threats are addressed in the CIE framework.

Data Collection↗

Quality of life as an endpoint in EORTC clinical trials. European Organization for Research and Treatment for Cancer.

For more than 30 years the European Organization for Research and Treatment for Cancer (EORTC) has conducted, co-ordinated, and stimulated research on the experimental and clinical bases of treatment of cancer and related problems. For more than a decade the EORTC has included quality of life as an outcome measure in some of its trials. The number of clinical studies that include QOL as an evaluation endpoint has increased rapidly in the last few years, and is still increasing steadily. This necessitated a careful and critical evaluation of procedures and results so far in order to generate appropriate guidelines and procedures for incorporating QOL issues in all stages of the clinical trial process, including protocol writing, data collection, data analysis, and reporting of results. This paper provides an overview of the types and the design of studies, data management of quality of life assessment, compliance, missing data and lessons learned during the past years with respect to QOL assessments in the EORTC studies.

Adult↗

Forensic family evaluations: a comprehensive model for professional practice.

This paper describes a model for forensic family evaluations (FFE) that arise from issues of child custody and maltreatment. FFEs are comprehensive assessments that utilize a variety of data collection methods. The FFE has three basic stages: beginning the evaluation, collecting data, and presenting the evaluation findings. In each stage there are a number of professional and administrative stations. Each stage of the FFE presents unique challenges: maintaining internal and external independence, managing issues of convergent validity, and monitoring written and verbal output. Each of these stages, stations, and challenges is discussed.

Child↗

The need for a consensus in the use of assessment tools for Alzheimer's disease: the Feasibility Study (assessment tools for dementia in Alzheimer Centres across Europe), a European Alzheimer's Disease Consortium's (EADC) survey.

AIMS: To ensure that all Alzheimer centres across Europe are capable of using a similar method of data collection. Information about the patient assessment tools used by each participating centre was obtained and normal clinical practice in each EADC centre was documented by collecting data from routine new patient consultation. METHODS: Twenty new consecutive patients with objective memory impairment were recruited in each Alzheimer centre over 6 months. Each patient consultation was carried out according to routine clinical practice. Patient data were recorded using the anonymous patient protocol (demographic, diagnosis, MMSE score, patient assessment scales, and most prominent behavioural problem). Information about neuropsychological assessment tools used in each centre was take to account to harmonise research practice for future multicentre collaboration. RESULTS: Seven hundred and four patients from 36 memory clinics in 13 countries across Europe participated in the study. [M:F ratio 0.67. Mean age 75.4 SD 9.3 (51-102) Mean MMSE 21 SD 6 (0-30)] Five hundred and fifty-five patients had a clinical diagnosis of dementia [Alzheimer's disease (68.5%), vascular dementia (10.3%), frontal lobe dementia (5.6%), Lewy body dementia (4.1%), mixed dementia (5.6%)]. Duration of symptoms: 0-6 months 6.5%; 6-12 months 16.1%; 1-2 years 30.5%; 2-5 years 46.9%. Assessment scales used: Clinical Dementia Rating (CDR) 48.9%, Reisberg's Global Deterioration Scale (GDS) 38.6%, ADL/IADL (Lawton and Brody, 1969) 37.5%, Neuropsychological Inventory (NPI) 28.6%, Geriatric Depression Scale 22%, ADL (Katz et al., 1963) 19.2%, ADAS-Cog 14.9%, Cornell Scale for Depression 12.9%, Grober and Bushke Selective Reminding Test 11.5%, ADCS/ADL 7.7%. 64.8% of the patients experienced behavioural symptoms: apathy 13.6%; anxiety 12.8%; dysphoria 9.9%; irritability 7.8%; agitation 5.5%; hallucinations 3.6%; delusions 3.6%, sleep disorder 2.4%; desinhibition 2%. CONCLUSIONS: The most common type of cognitive decline was Alzheimer's disease followed by mild cognitive impairment and vascular dementia. CDR, GDS Reisberg, and ADL/IADL were used widely (40-50%). The NPI, geriatric depression scale and ADL (Katz, 1963) were only used in 20% of the centres. We verified large differences in the tools use in the EADC centres to evaluate patients with dementia across Europe. There is a need for a consensus in the use of assessment tools for dementia in Alzheimer's centres in Europe.

Age Distribution↗

Data management of a case-control study with a large number of variables.

The description is presented of the system design and implementation experience obtained while providing the data management for a case-control study involving a large number of variables. Topics concerning questionnaire design, data collection, data coding, data entry, data edit, and data storage and retrieval are discussed. Designing and implementing the data-processing system for such a study provides diversified data management experience. This experience results in the investigation of existing and the development of new procedures and documents that can be applied to other studies in medical research. Emphasis is placed on the presentation of system details that can be tailored to specifications for a variety of studies.

Adult↗

Learning statistical methods.

Since at least 1951 anesthesia journals have called for a more rigorous application of statistical methods in research reports. This appeal for statistical excellence actually applies to the researcher, to the clinician journal reader, and to the editor. Thirty five years ago the obligations of these three groups was made clear in an unsigned editorial in Anesthesiology; there is now a widespread consensus on these responsibilities. The researcher must create valid science. The clinician reader must bring sufficient intellectual skills to understand a journal article; using these skills the reader must critique the research report to judge its applicability to his patients. The editor must decline manuscripts showing poor or absent application of the scientific method, experimental design, and statistical analysis. Though the editors continue to exhort further improvements, even a casual perusal of their journals demonstrates a tremendous improvement in the handling of numeric data over the last four decades. With the increasing sophistication of statistical methods in journals, the reader must continue to expand his statistical understanding. In this short review, a few highlights of statistical methods useful either in planning and accomplishing a research project or in reading a research report will be discussed; these include the planning of a study design, data collection, data analysis, and interpretation of the research. Comments about using these concepts to better understand a research article will be included. Also included will be an annotated reading list for further study and reference. Mathematical formulas have been avoided as much as possible. Actual use of statistics requires use of equations which can be found in the books of the reading list.

Biometry↗

Video-Assisted Thoracic Surgery Study Group.

Both patients and the medical profession are quick to embrace new technology, particularly when it may replace an existing surgical procedure. Unfortunately, the rapidity of acceptance is rarely associated with careful evaluation. Laparoscopy is a recent example of such widely embraced technology. Studies of laparoscopy that yielded good comparative data to more traditional methods were slow to accrue. This led to the exposure of its shortcomings through governmental reports and the lay press. To prevent this from happening in thoracoscopy, two types of studies are required so that valid conclusions about the new technology can be drawn. The first is an accounting of the new technology as procedures evolve around it. The data collected in such a study should contain basic information, including the indications for the procedure, how it was performed, procedure length, associated complications, and patient outcome. Such information provides a broad profile of the technology, emphasizing from the outset its potential strengths and weaknesses. The second type of study involves a more detailed concurrent comparison of the specific procedures utilizing this technology to the established traditional methods. Such randomized studies help to firmly establish through scientific process the place of the new technology. The Video-Assisted Thoracic Surgery Study Group was organized in early 1992 to address these concerns. From an initial four surgeons the group has grown to include more than 41 institutions. Currently the group is collecting data in a registry and has established three clinical trials to evaluate video-assisted thoracic surgery.(ABSTRACT TRUNCATED AT 250 WORDS)

Canada↗

Comparison of epidemiologic data from multiple sources.

We compared epidemiologic data collected from medical records and by interview for 462 subjects who were part of a case-control study of a chronic disease (cancer of the breast). The collected data included such clinical and pharmaceutical features as history of lactation, hysterectomy, diabetes mellitus, type of menopause, and whether a woman had used exogenous estrogens. We found that agreements between medical record and interview data are variable, and depend on the type of data examined and the strategy for handling incomplete or ambiguous (indeterminate) responses. For variables that represent inherent features of the patients' clinical condition, such as gynecologic surgical procedures and a family history of breast cancer, we found excellent agreement between the medical record and interview. For pharmaceutical features, however, we discovered considerable variability between the two data sources. We also detected substantial problems with a common tactic in which information from individual data sources are pooled to form a new "combined data source". In this analysis, combining data sources creates estimates for the proportion exposed that are different from estimates in either of the original information sources.

Breast Neoplasms↗

A microcomputer interface for a digital audio processor-based data recording system.

An inexpensive interface is described that performs direct transfer of digitized data from the digital audio processor and video cassette recorder based data acquisition system designed by Bezanilla (1985, Biophys. J., 47:437-441) to an IBM PC/XT microcomputer. The FORTRAN callable software that drives this interface is capable of controlling the video cassette recorder and starting data collection immediately after recognition of a segment of previously collected data. This permits piecewise analysis of long intervals of data that would otherwise exceed the memory capability of the microcomputer.

Biophysical Phenomena↗

Validation of a predictive model for postoperative pulmonary complications.

OBJECTIVE: To test or validate a previously reported model for predicting postoperative pulmonary complications (PPCs) after elective abdominal surgical procedures. DESIGN: Prospective, descriptive. SETTING: Four midwestern hospitals serving a diverse population of patients. PATIENTS: Two hundred seventy-six adult patients who had undergone abdominal surgery (51% men, 49% women; mean age 54.1 +/- 5.3 years). OUTCOME MEASURES: PPC developed in 26.4%. DATA COLLECTION: Data were collected preoperatively during a brief interview and a pulmonary physical examination and on the first 6 postoperative days. RESULTS: A six risk-factor model was tested in this sample of subjects. The model validated relatively well in the sample of 276 subjects with use of the basic criteria of correct classification, sensitivity, and specificity. However, when a new model was developed from this sample, differing risk factors emerged as significant independent predictors. CONCLUSIONS: Further research is needed to assess the stability of the risk factors and test the models in differing settings and populations of patients.

Abdomen↗

Practical issues in conducting pharmacoeconomic studies.

Many difficulties are inherent to pharmacoeconomic studies. Because these studies are observational, there are many factors that cannot be controlled; for example, there are many variations across the country in the practice of any particular therapy. Therefore, designing a case report form that will match the source documents from various investigator sites is not easy. Issues arise in every activity such as choice of investigator site, data collection, data analysis, and interpretation of the results. These issues will be discussed, and an example of a pharmacoeconomic study conducted to evaluate the cost-effectiveness of patch testing in patients diagnosed with allergic contact dermatitis will be presented.

Clinical Trials as Topic↗

Effectiveness of primary and secondary enforced seat belt laws.

OBJECTIVE: The objective of this study was to determine the relative efficacy of primary and secondary enforced motor vehicle occupant restraint laws on the outcomes of restraint use, crash-related mortality, and crash-related injuries. SEARCH STRATEGY: We used the Cochrane Collaboration search strategy to search the following electronic databases: MEDLINE, EMBASE, National Technical Information Service (NTIS), Psyc-INFO, ERIC, Nursing and Allied Health (CINAHL), Transportation Research Information Service (TRIS), and EI Compendex. The reference lists from each potentially eligible study were checked, and knowledgeable people in the field were contacted, for additional leads to published reports. SELECTION CRITERIA: Studies had to include a comparison of primary enforcement law to no law, secondary enforcement law to no law, or a primary to a secondary law. Any study design was acceptable. Acceptable outcome measures included observed restraint use, and counts or rates of deaths or serious injuries. DATA COLLECTION: Data were collected using a standard abstract reporting from. Relative differences in outcomes and absolute differences were calculated when possible. MAIN RESULTS: We identified 48 studies for the review. When places or time periods with primary enforcement laws were compared to those without such laws, the relative prevalence of seat belt use ranged from 1.5 to 4.5; the prevalence differences ranged from 10 to 50 per 100 observed drivers. Secondary laws had smaller effects. Two studies evaluated a change in law from secondary to primary enforcement; this was associated with an increase in belt use 6 months later of 5.3 per 100 observed drivers in Louisiana and 18 per 100 drivers in California. Primary enforcement laws were associated with a relative risk of death in MV crashes of .54 to .97. The reduction in mortality associated with secondary enforcement laws was much more modest, with relative risks estimates of .81 to 1.025. Primary enforcement laws were associated with a relative risk of severe injuries of .20 to .89; the association of secondary enforcement laws with severe injuries was smaller. CONCLUSIONS: Our review of existing studies suggests that primary enforcement laws are likely to be more effective than secondary laws. However, few studies are of good quality, and quantitative estimates of the relative effect of primary compared with secondary laws are limited.

Accidents, Traffic↗

Conducting research in respondents' homes: benefits, problems, and strategies.

In summary, homes are valuable yet underused sites for data collection. Although homes are more frequently used for qualitative research because of the nature of qualitative inquiry requiring few distractions and more reflection, homes also can be used for quantitative studies. One major benefit of collecting data in homes is that of obtaining health-related information when a person is at baseline versus in a crisis situation. With adequate funding, attention to safety, and a mechanism for making and confirming appointments, homes serve as valuable sites for obtaining data.

Adult↗

Mass gathering medicine: a predictive model for patient presentation and transport rates.

INTRODUCTION: This paper reports on research into the influence of environmental factors (including crowd size, temperature, humidity, and venue type) on the number of patients and the patient problems presenting to first-aid services at large, public events in Australia. Regression models were developed to predict rates of patient presentation and of transportation-to-a-hospital for future mass gatherings. OBJECTIVE: To develop a data set and predictive model that can be applied across venues and types of mass gathering events that is not venue or event specific. Data collected will allow informed event planning for future mass gatherings for which health care services are required. METHODS: Mass gatherings were defined as public events attended by in excess of 25,000 people. Over a period of 12 months, 201 mass gatherings attended by a combined audience in excess of 12 million people were surveyed throughout Australia. The survey was undertaken by St. John Ambulance Australia personnel. The researchers collected data on the incidence and type of patients presenting for treatment and on the environmental factors that may influence these presentations. A standard reporting format and definition of event geography was employed to overcome the event-specific nature of many previous surveys. RESULTS: There are 11,956 patients in the sample. The patient presentation rate across all event types was 0.992/1,000 attendees, and the transportation-to-hospital rate was 0.027/1,000 persons in attendance. The rates of patient presentations declined slightly as crowd sizes increased. The weather (particularly the relative humidity) was related positively to an increase in the rates of presentations. Other factors that influenced the number and type of patients presenting were the mobility of the crowd, the availability of alcohol, the event being enclosed by a boundary, and the number of patient-care personnel on duty. Three regression models were developed to predict presentation rates at future events. CONCLUSIONS: Several features of the event environment influence patient presentation rates, and that the prediction of patient load at these events is complex and multifactorial. The use of regression modeling and close attention to existing historical data for an event can improve planning and the provision of health care services at mass gatherings.

Anniversaries and Special Events↗

Quality of cancer registry data: a comparison of data provided by clinicians with those of registration personnel.

The quality of cancer registry data is of great importance to the usefulness of a cancer registry. To investigate the quality of its data the IKL cancer registry (Integraal Kankercentrum Limburg) performed a study with the aim of comparing data supplied by clinicians with data collected by registration personnel. Twenty clinicians reabstracted the information of a random sample of about ten of their patients, who were diagnosed with cancer in 1989 or 1990. After coding, the information was compared with the contents of the cancer registry records. For comparison of agreement the information of 190 cases was available. The relative frequency of major disagreements was 0% for date of birth, 0% for gender, 5% for date of incidence, 6% for primary site, 2% for laterality, 2% for histologic type and 2% for behaviour code. In general, the disagreements could be attributed to the handling of different coding rules (incidence date), or to a lower level of precision by the clinician in comparison to registration personnel (primary site, laterality). This study has shown that registration personnel are able to collect data with a high degree of accuracy.

Data Collection↗

Raising research awareness among midwives and nurses: does it work?

OBJECTIVE: The primary aim of the study was to evaluate the effectiveness of two approaches to increase research awareness among midwives and nurses. DESIGN: Quasi-experimental with the attitudes of staff in the two groups being measured at two points (January and October 1997). SAMPLE: All midwives and nurses working in four clinical areas in an acute NHS Trust. The intervention arm of the study involved all midwives and nurses in the Clinical Directorate of Obstetrics and Gynaecology, while the control arm involved all nurses working in a specialist oncology and haematology unit and in the children's directorate. ETHICS: The Joint Ethics Committee considered approval unnecessary because the study involved staff and not patients. DATA COLLECTION: Data were collected by self-complete questionnaires. INTERVENTIONS: A programme of education with policy and practice interventions targeted at ward sisters. OUTCOME MEASURES: Staff attitudes to, knowledge of, and level of involvement in, research. RESULTS: The study demonstrated a significant increase in both knowledge and use of research resources. Following the programme of education, staff in the intervention group were significantly more likely to use resources associated with research utilization and to report that they had read a research paper within the last month. STUDY LIMITATIONS: The time scale of the intervention was restricted by the funding available; a significant Hawthorne effect was evident with both groups showing an increase in knowledge; the pragmatic nature of the study meant that it was not possible to randomize the study groups; the scale of the study did not permit an economic evaluation. CONCLUSIONS: The introduction of clinical governance challenges healthcare providers to improve the care they deliver. There are huge opportunities for Trusts to invest in developing staff knowledge and use of research. However, staff will only seize these opportunities if there is an appropriate, enabling environment--an environment that delivers intensive interventions and is sensitive to the wider structural factors in the NHS affecting staff morale and commitment. In the absence of this environment, what may be seen as opportunities to managers may be regarded as just another burden by staff.

Attitude of Health Personnel↗