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PubMed2002

Data management in practice-based research.

OBJECTIVE: Multi-site data collection is complex and requires an effective data management system. This article explores data management issues encountered in the design, conduct, and analysis of a research project involving 74 community-based sites and a central data management system. RESULTS: Once the data arrived at the central site, data integrity was maintained at a very high level. Issues encountered in our study on low back pain reflected the practice-based nature of the study and the limitations of finances, staff, and facilities. CONCLUSION: The task of converting a research protocol to actual procedures for data collection and data management can be very challenging. The importance of early recognition of the effort and resources needed for data management and quality-control procedures cannot be overestimated.

Community Health Centers↗

PubMed2002

Improving patient satisfaction: a control chart case study.

Health care providers both in inpatient and outpatient settings commonly use patient satisfaction surveys. However, when the surveys are administered and the results are interpreted without attention to sound scientific methodology, the findings may be useless and even misleading. As a result, money and resources are wasted. To use surveys to improve patient care, providers must first obtain high-quality data. This requires choosing an instrument that is valid and reliable, employing an appropriate and credible sampling method, and obtaining a representative response rate. Providers are then faced with the difficult challenge of interpreting and responding to the survey findings. This article addresses this latter task by presenting a case study that demonstrates how control charts can be used to interpret survey findings, develop improvement plans, and assess the effectiveness of these plans.

Ambulatory Care Facilities↗

PubMed2001

Control charts 101: a guide to health care applications.

A control chart can be an effective way to display process data over time. It can differentiate common cause variation from special cause variation through the application of several probability-based interpretation rules. In addition, a control chart can be helpful in evaluating the effectiveness of a change. There are numerous types of control charts, and this tutorial was developed to guide the user through the selection process.

Data Collection↗

PubMed2003

[Haemovigilance in the health care establishment: its role in pediatric transfusion].

Haemovigilance, an important step in transfusion safety, had been set up by a French law in January 1993. Application of haemovigilance in public hospitals is based on three conditions: reporting of adverse transfusion events, traceability of blood products and prevention of adverse transfusion events. The implementation of haemovigilance follows the rules given in a Ministry order dated January 1994, the first of a series including regulations about patient information, virological follow-up of transfused patients, blood product distribution. Haemovigilance rules are the same for adults as for children, concerning blood product traceability and adverse event reporting. It is much more difficult in other fields such as autologous transfusion and "child-patient" information that depend on their parent advice and should be particularly adapted to the familial context, the type of disease and the treatment. Difficulties arise for completing pre- and post-transfusion, immuno-haematologic and virologic controls. Compliance to protocols, in agreement with blood banks, is necessary.

Adolescent↗

PubMed2001

An outsider's view of Dutch euthanasia policy and practice.

This article provides a critical analysis of Dutch euthanasia policy and practice. The research benefited from twenty-eight interviews conducted in the Netherlands during the summer of 1999 with some of the leading figures who dictate the decision-making process and take an active part in the debates. The discussion begins with a review of the two major Dutch reports on euthanasia and the conflicting views and interpretations offered by the literature. Next, I provide some data about the interviews, and then analysis indicating that the Dutch Guidelines on the policy and practice of euthanasia do not provide ample mechanisms against abuse. I argue that the Dutch Guidelines are insufficient, do not provide adequate control over the practice of euthanasia, and that the entire policy should be revised and made more coherent and more comprehensive.

Attitude to Health↗

PubMed2003

[Effects of contemporaneous control of DRG-relevant coding by physicians].

OBJECTIVE: In a prospective study we analysed the quality of ICD-coding in clinical everyday life of a department for internal medicine. METHODS: A skilled intern--the so-called DRG assistant--was temporarily released from clinical work. Over nine weeks he had to control all diagnoses contemporaneously that were ICD-coded by his colleagues on admission and discharge of their patients. The DRG-assistant had to ask for missing or correct implausible diagnoses, or inappropriate ICD-coding and with it also train his colleagues in appropriate coding. The effects of the DRG-assistant's correction of coding, on DRG-consistent grouping and on the potential financial loss or benefit generated by his work were recorded. After stoppage of this control in a subsequent phase of the study the effect of the absence of the DRG-assistant, the absence of reminders and coding control and the changes of the clinic's revenue were determined. RESULTS: Corrections of ICD-coding by the DRG-assistant alone caused a remarkable increase in case-mix-index (CMI). CMI's mean value increased from 1.76 to 1.84 and the clinic's revenue increased by 180 Euro per patient (a total of about 80,000 Euro in nine weeks). After the end of the control, the case-mix-index dropped within three weeks down to 1.14, corresponding with a potential loss of 1200 Euro per patient (assuming that patients' morbidity was the same over the time of the study). Coding corrections could not improve CMI in this situation. CONCLUSION: Contemporaneous control of ICD-coding by physicians seems to be essential in DRG based accounting.

Costs and Cost Analysis↗

PubMed2006

The risk of upcoding in casemix systems: a comparative study.

With the introduction of a diagnosis related group (DRG) classification system in the Netherlands in 2005 it has become relevant to investigate the risk of upcoding. The problem of upcoding in the US casemix system is substantial. In 2004, the US Centres for Medicare and Medicaid estimated that the total number of improper Medicare payments for the Prospective Payment system for acute inpatient care (both short term and long term) amounted to US$ 4.8 billion (5.2%). By comparing the casemix systems in the US, Australian and Dutch healthcare systems, this article illustrates why certain casemix systems are more open to the risk of upcoding than other systems. This study identifies various market, control and casemix characteristics determining the weaknesses of a casemix reimbursement system to upcoding. It can be concluded that fewer opportunities for upcoding occur in casemix systems that do not allow for-profit ownership and in which the coder's salary does not depend on the outcome of the classification process. In addition, casemix systems in which the first point in time of registration is at the beginning of the care process and in which there are a limited number of occasions to alter the registration are less vulnerable to the risk of upcoding. Finally, the risk of upcoding is smaller in casemix systems that use classification criteria that are medically meaningful and aligned with clinical practice. Comparing the US, Australian and Dutch systems the following conclusions can be drawn. Given the combined occurrences of for-profit hospitals and the use of the secondary diagnosis criterion to classify DRGs, the US casemix system tends to be more open to upcoding than the Australian system. The strength of the Dutch system is related to the detailed classification scheme, using medically meaningful classification criteria. Nevertheless, the detailed classification scheme also causes a weakness, because of its increased complexity compared with the US and Australian system. It is recommended that researchers and policy makers carefully consider all relevant market, control and casemix characteristics when developing and restructuring casemix reimbursement systems.

Australia↗

PubMed2001

[Statistical Process Control applied to viral genome screening: experimental approach].

During the National Multicentric Study concerning the introduction of NAT for HCV and HIV-1 viruses in blood donation screening which was supervised by the Medical and Scientific departments of the French Blood Establishment (Etablissement français du sang--EFS), Transcription-Mediated transcription Amplification (TMA) technology (Chiron/Gen Probe) was experimented in the Molecular Biology Laboratory of Montpellier, EFS Pyrénées-Méditerranée. After a preliminary phase of qualification of the material and training of the technicians, routine screening of homologous blood and apheresis donations using this technology was applied for two months. In order to evaluate the different NAT systems, exhaustive daily operations and data were registered. Among these, the luminescence results expressed as RLU of the positive and negative calibrators and the associated internal controls were analysed using Control Charts, Statistical Process Control methods, which allow us to display rapidly process drift and to anticipate the appearance of incidents. This study demonstrated the interest of these quality control methods, mainly used for industrial purposes, to follow and to increase the quality of any transfusion process. it also showed the difficulties of the post-investigations of uncontrolled sources of variations of a process which was experimental. Such tools are in total accordance with the new version of the ISO 9000 norms which are particularly focused on the use of adapted indicators for processes control, and could be extended to other transfusion activities, such as blood collection and component preparation.

Blood Component Removal↗

PubMed2005

MediClass: A system for detecting and classifying encounter-based clinical events in any electronic medical record.

MediClass is a knowledge-based system that processes both free-text and coded data to automatically detect clinical events in electronic medical records (EMRs). This technology aims to optimize both clinical practice and process control by automatically coding EMR contents regardless of data input method (e.g., dictation, structured templates, typed narrative). We report on the design goals, implemented functionality, generalizability, and current status of the system. MediClass could aid both clinical operations and health services research through enhancing care quality assessment, disease surveillance, and adverse event detection.

Artificial Intelligence↗

PubMed1979

Quality control enhanced by chart review.

A long-term care facility developed, tested, and implemented criteria for documenting care, a procedure for regular review of charts, and quantitative methods of evaluating reviews.

Chicago↗

PubMed2001

Health care organization improvement reports using control charts for key quality characteristics: ORYX measures as examples.

Some medical centers have developed quarterly quality performance reports consisting of key quality characteristics reported in the form of annotated control charts. The content of these reports needs to be linked with the mission, vision, values, and the structure of the organization. A partial example using one hospital's Joint Commission on Accreditation of Healthcare Organizations' ORYX measures is presented along with comments. The examples have been chosen to show the use of different types of control charts (XmR, P, and rare events) and different clinical conditions (congestive heart failure, low birth weight, and chronic obstructive pulmonary disease).

Data Collection↗

PubMed1992

[The follow-up of the orthodontic treatment of facial cleft patients with the Göttingen computer-supported documentation system].

The care of patients with cleft lip, alveolus, and palate demands supervision of the development and progress over a long period of time. It also requires a standardized and systematic basic documentation. In our cleft center the documentation is summarized on one sheet of paper with DIN-A4 formation (297 x 210 mm). The use of electronic data processing improves the documentation. The storage of general and medical data has been supplemented by a personal computer system, PC-System. Five years after developing of this computer aided documentation system several patients are shown as examples for the application of this system for longterm control patients with cleft lip, alveolus, and palate.

Child↗

PubMed1987

The liabilities and consequences of medical device development.

A large increase in medical products liability litigation during the past 40 years has resulted in a flood of litigation against drug and device manufacturers. The medical technology and chemical industries are prime targets for products liability litigation. Physicians and other health care providers are willing to accept a reasonable degree of risk associated with the use of a medical product when compared to the benefit to be achieved by that product but lay juries are less likely to tolerate the concept of an acceptable failure rate. Plaintiffs' lawyers believe that the medical products industry should be held to a standard of absolute liability and that anyone injured by a medical product is entitled to recover without regard for the circumstances. Large compensatory and punitive damage awards, the high cost of insurance, large defense costs, and low profit margins have forced some companies to remove their products from the market. The medical or biomaterials manufacturer can significantly reduce its exposure for products liability by adopting a successful product safety program. Manufacturers have significant control over the quality, safety, and reliability of their products through appropriate design, testing, manufacture, labeling, and sale of quality products.

Biotechnology↗

PubMed1994

[Blood transfusion and quality assurance].

Administrating safe blood products and being able to produce the evidence of procedures correctly employed, is today vital for healthcare professionals. Industrial quality assurance is an appropriate answer to this problem. Indeed, this approach allows the mastering of a processing system thanks to the combination of three elements: a detailed description of processes, control mechanisms and corrective measures. It relies on an information system and must be applied to all steps of blood transfusion.

Blood Banks↗

PubMed1992

Guidelines for platelet transfusions. British Committee for Standards in Haematology, Working Party of the Blood Transfusion Task Force.

Recommendations for the optimal transfusion support of patients likely to receive repeated platelet transfusions. 1. Determine policy for prophylactic platelet support, and select the platelet count below which platelet transfusions will be used. 2. Consider using leucocyte depletion of red cell and platelet concentrates to prevent HLA alloimmunization from the outset. 3. Type patients for HLA-A and B antigens at an early stage. 4. Use random donor platelet concentrates for initial platelet support (either single or multiple donor, depending on availability). 5. If refractoriness occurs, determine whether clinical factors, which may be associated with non-immune consumption of platelets, are present and test the patient's serum for HLA antibodies. 6. Use HLA-matched platelet transfusions if HLA alloimmunization is the most likely cause of refractoriness. 7. If there is no improvement with HLA-matched transfusions, platelet crossmatching may identify the cause of the problem and help with the selection of compatible donors. 8. Discontinue prophylactic platelet support if a compatible donor cannot be found. Use platelet transfusions from random donors to control bleeding and increase the dose, if necessary.

Blood Coagulation Disorders↗

PubMed1979

A study of repeat prescription cards in a general practice.

A study of repeat prescription cards in a general practice revealed problems in good record keeping and patient recall. A system involving a repeat register was therefore developed to create an easily accessible practice record and a recall procedure was initiated. Greater control over repeat cards is now possible.Examination of the age and sex of the card-holders showed a high proportion of elderly females. By scrutiny of the contents of the cards, a profile of prescribing in the practice was drawn and this was used as material for discussion of prescribing policy.Finally, the system has potential to monitor patients with chronic diseases where regular medication is essential.

Drug Prescriptions↗

PubMed1997

Reduction of inappropriate use of blood products by prospective monitoring of transfusion request forms.

OBJECTIVE: To determine the effect of prospective monitoring on appropriateness of transfusions of red cells, platelets and fresh frozen plasma (FFP). DESIGN: Prospective interventional study. SETTING: Royal Melbourne Hospital (a tertiary teaching hospital), Melbourne, Victoria, March-May 1996. INTERVENTION: The blood product request form was modified to incorporate indications for transfusion and clinical and laboratory data. Requests were monitored by blood bank laboratory staff for conformation with hospital transfusion guidelines; non-conforming requests were discussed with the requesting medical practitioner by the Haematology Registrar before blood products were issued. In case of disagreement, blood products were always issued. SUBJECTS: 200 consecutive transfusion episodes for each product (red cells, platelets and FFP). OUTCOME MEASURES: Appropriateness of transfusion, assessed by a Consultant Haematologist according to hospital guidelines. Rates of inappropriate transfusion episodes after intervention were compared with rates in a previous study. RESULTS: After intervention, rates of inappropriate transfusion episodes fell significantly (red cells, 16% to 3% [P = 0.004]; platelets, 13% to 2.5% [P = 0.02]; and FFP, 31% to 15% [P = 0.02]). Almost all inappropriate FFP transfusion episodes post-intervention were due to failure to demonstrate prolongation of prothrombin or activated partial thromboplastin times more than 1.5 times the control value. CONCLUSION: Prospective monitoring of request forms can reduce rates of inappropriate transfusions. High rates of inappropriate FFP transfusions possibly reflect uncertainty about appropriate laboratory criteria for FFP transfusion. While results of large prospective randomised controlled clinical trials of FFP transfusions are awaited, currently laboratory criteria can be retained, but should be applied with flexibility.

Blood Component Transfusion↗

PubMed2004

[The clinical record as a document of total quality system: a practical example].

Recent analyses indicate that the ratio between total insurance policies paid out and those for damages for malpractice are 1:3. Bad organization of clinical records by doctors is among the main causes of this phenomenon. In fact, clinical records can be considered a public document as well as a means of verifying quality controls. Having precise procedures for the management of clinical records can be useful to demonstrate objectivity both in diagnosis and treatment choice--which can be very important in court cases. This paper illustrates some practical proposals for a correct organization and administration of clinical records.

Forms and Records Control↗