Plan-do-study-act cycles as an instrument for improvement of compliance with infection control measures in care of patients after cardiothoracic surgery.

The aim of this study was to determine whether compliance with infection control measures for the care of patients during and after cardiothoracic surgery could be improved by using 'plan-do-study-act' (PDSA) improvement cycles in a 715-bed university hospital. The endpoints of these cycles were indices of correct procedure based on infection control standards. The intervention consisted of instruction and training of nursing and medical staff on the use of PDSA cycles, feedback of the baseline measurements, and the use of posters in the proximity of the operating room (OR). At follow-up, overall compliance only improved in the room used by the perfusionists and the OR. After the follow-up period, monitoring revealed a drop in compliance in the OR, but improved compliance during vascular catheter care of patients with prolonged stay in the intensive care unit (ICU), and during wound care of patients on the nursing ward. The last series of monitoring showed that compliance with general infection control measures in the OR had improved again, and that compliance had remained satisfactory on the ward and in the ICU, with the exception of patients recently transferred to the ICU from the OR. The results show that by using PDSA cycles, compliance with infection control measures can improve significantly. However, repeated monitoring is necessary to ensure continued compliance.

Assessing the necessity of hospital stay by means of the appropriateness evaluation protocol: how strong is the evidence to proceed?

OBJECTIVE: To review the Appropriateness Evaluation Protocol (AEP) with respect to assessing the necessity of hospital stay at the University Hospital of Maastricht. DESIGN: Literature search in Medline focusing on the validity, reliability and possibilities for intervention plus a description and the first results of pilot studies with a Dutch version of the Adult-Medical AEP (days of stay). SETTING: The University Hospital of Maastricht, a 700-bed university and regional hospital in the south of The Netherlands. MAIN OUTCOME MEASURES: Face, content, and convergent validity, and reliability in terms of overall or specific agreement and by kappa, of the Adult-Medical AEP when used by physicians and nurses. RESULTS: In comparison with other instruments, a comparatively good performance by the AEP has been reported in the literature. Literature review revealed limitations in the AEP as a general and truly valid and reliable instrument for assessing the necessity of hospital stay. In applying a Dutch version (azM-AEP) similar difficulties were encountered. CONCLUSION: Based on the literature review and our own findings, we conclude that the validity and reliability of the different versions of the AEP are not yet up to standard. Regarding the results of the interventions thus far, we do not encourage further use until additional improvements to both the instrument and the review conditions have been made. Perhaps a more disease-specific modulation and assessments based on computerized medical records could improve its applicability in clinical practice in general.

Patient satisfaction with clinical trial participation.

OBJECTIVE: To assess satisfaction of patients who participate in clinical trials requiring informed consent and to analyse factors determining patient satisfaction. SETTING: The survey took place in 26 clinical trials at the University Hospital Maastricht (azM), The Netherlands. DESIGN AND STUDY PARTICIPANTS: A personal interview and telephone questionnaire were used consecutively (n= 135; 135 out of 172=78.5% response rate) to measure patient's expectancies before starting the trial during the informed consent procedure and to evaluate aspects of trial participation. An additional control group of 34 patients was interviewed only by telephone (100% response). MEASURES: Satisfaction was assessed in two distinct ways: first, by measuring the patient's subjective evaluation of several aspects of trial participation; secondly, by comparing prior expectations and subsequent evaluations. Patient satisfaction was subdivided with respect to medical-technical, interpersonal and organizational aspects of trial participation. Changes in patient's health and illness perceptions were regarded as confounding factors in the relationship between satisfaction and its possible causes. RESULTS: Although patient satisfaction was quite high, dissatisfaction with aspects of trial participation became apparent when both prior expectations and subsequent evaluations were compared with each other. CONCLUSION: Prior expectations and general attitudes towards medical care and research before entering the trial have an impact on satisfaction with aspects of trial participation (10-20% explained variance). No linear relationship was found between perceived improvements in health and illness conditions and patient satisfaction with trial participation.

Determinants of patient participation in clinical studies requiring informed consent: why patients enter a clinical trial.

In a survey on 26 clinical trials we have studied the reasons why some patients choose to participate in clinical trials while others decline. Interviews were held with 198 adult patients, just after they had been asked by the trial-clinician to participate. We interviewed patients who were asked to participate in a clinical trial, including those who decided not to participate. The theoretical guidelines to explain participation were based on an extended form of the Health Belief Model. Patients being asked to participate in a clinical trial decide by making a personal balance account. This comprises the physical and emotional added value patients hope to gain from the trial treatment compared to the non-trial treatment, minus the risks they expect in the trial and minus the extra time they expect the trial will take. The extent they feel physically threatened by their illness will also influence their decision. Furthermore, this personal balance account was found to depend on patient opinion about medical care and care-givers in general and on how patients regard their illness. Relatively long-term patients show a slightly different motivation to participate in a clinical trial than short-term patients. In line with the Health Belief Model, motivational beliefs on the relevance to reducing the threat to the patient's health condition ('values') and the evaluations of the clinical trial the patient is approached for ('expectancy'), are relevant in explaining patient behavior. Moreover, specific evaluative frames of reference are relevant in patients faced with the choice to participate or not. Suggestions are made to improve insight into patient motivation during the informed consent procedure of clinical trials.

Myth and reality of informed consent in clinical trials.

Informed consent is a prerequisite for any medical intervention or for participation in scientific research. Legal requirements in health care towards informed consent provide qualifications of information disclosure and focus on procedures to obtain a valid consent. The premise of informed consent as a rational decision making process implies an informed consideration, assessment and patient choice and may be perceived as an ideal in the nature of a myth. These principles and assumptions will be discussed to obtain more insight into informed consent in clinical trials. A cogent model of informed consent is presented, which could be useful in clinical trials. We suggest a gradual distinction between informed consent in regular treatment vs. clinical trials, based on concepts like achievable benefits and risk disclosure. Suggestions are made for further empirical research, to obtain more insight into the myth and reality of informed consent in clinical trials.

Patients' perceptions on informed consent and the quality of information disclosure in clinical trials.

In a survey on 26 clinical trials we studied how patients experience and evaluate the information disclosure on the clinical trial they are enrolled in and which factors influence patients' perceptions of information disclosure. Our objective was to obtain more insight thereby in how informed consent is applied in the daily practice of clinical trials. Interviews were held with 198 adult patients and 32 trial-clinicians. Instead of focusing on patient comprehension of the information disclosed we analyzed patient perceptions of informed consent. Patients proved to be quite satisfied with the oral and written information disclosure. Patients' perceptions of the manner and content of information disclosure are influenced by more general attitudes towards medical care, research and institutions. Patients' trust in medical experiments, belief in the integrity of physicians and interest in medical affairs have an impact on the way patients perceive information disclosure. To improve the quality of the informed consent procedure, we propose a patient motivation classification (PMC) to enable trial-clinicians to gain more insight into patient motivation. Relevant factors found in our data have been used as criteria for classification. An informed decision making checklist (IDC) is suggested for patients as a general outline for patient education, covering relevant socio-psychological factors of enrollment.

Informed consent in clinical trials.

A review is provided in this paper on the empirical literature on informed consent from 1979 to 1995 referring to information disclosure and trial participation in clinical trials. Articles being reviewed focus upon information disclosure, reactions to disclosure and recall, features of consent and perceptions of informed consent, both in hypothetical and in real life situations. It is concluded that further research is needed to study the process of informed consent in clinical trials, to obtain a better insight into the myth and reality of informed consent in daily practice. Future studies should come forward on the limitations of previous empirical research on informed consent. Additional research should focus on the perspectives of patients who accept or decline trial participation.

Quality assurance in health care. From a traditional towards a modern approach.

This review article is about some recent developments in quality assurance in health care. A traditional and a modern approach are distinguished. The traditional approach is marked by a medical perspective and quality is defined as a property of medical care. Development of standards and criteria and inspection of conformance to them is the guiding principle for traditional medical quality assurance. The modern approach is marked by a strong influence of industrial principles on medical quality assurance. Industrial principles provide a new theory upon which medical quality assurance can be based. Aspects of care which are associated with the perceived quality are identified and are legitimate objects of medical quality assurance. The guiding principle is to influence experiences of (internal or external) customers by modelling the care according to clarified expectations. The university hospital of Maastricht provides an example of how modern principles of quality assurance are put into practice.

[The effectiveness of quality assurance committees in a university hospital]. / Efectividad de los comités de garantía de calidad en un hospital universitario.

Several groups are developing quality assurance activities in the University Hospital Maastricht, The Netherlands. The coordination of these groups to establish a coherent quality system has been set up as follows. The Board for Quality, set up by the Board of Governors in 1990 is constituted by representatives from medical, nursing, education and research departments. This board is in charge of coordinating the activities of quality assurance committees. The Board for Quality conducted a survey to collect information for assessing the extent to which these committees influence the quality of care. A questionnaire was filled in by all members of each committee (n = 162). Several persons participated in more than one committee (121 persons in total), with 82 respondents. After the analysis of results, the chairman and secretary of each committee were interviewed to discuss results. Means to improve the performance of these committees were indicated by the survey, and implemented where necessary. In most cases the activities of the committees proved to be relevant to the quality of care. The survey was useful as a monitoring tool and feedback-mechanism for committees to control their activities.

[Service quality in health care: the application of the results of marketing research]. / La calidad de servicio en la atención a la salud: applicación de resultados de la investigación mercadotécnica.

This paper deals with quality assurance in health care and its relation to quality assurance in trade and industry. We present the service quality model--a model of quality from marketing research--and discuss how it can be applied to health care. Traditional quality assurance appears to have serious flaws. It lacks a general theory of the sources of hazards in the complex process of patient care and tends to stagnate, for no real improvement takes place. Departing from this criticism, modern quality assurance in health care is marked by: defining quality in a preferential sense as "fitness for use"; the use of theories and models of trade and industry (process-control); an emphasis on analyzing the process, instead of merely inspecting it; use of the Deming problem solving technique (plan, do, check, act); improvement of the process of care by altering perceptions of parties involved. We present an experience of application and utilization of this method in the University Hospital Maastricht, The Netherlands. The successful application of this model requires a favorable corporate culture and motivation of the health care workers. This model provides a useful framework to uplift the traditional approach to quality assurance in health care.