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Background: Long waiting times for elective surgical treatment threaten timely care provision in several countries. The purpose of this study was to assess the impact of waiting for elective general surgery on the quality of life and psychosocial health of patients. Methods: A cross-sectional questionnaire study with postoperative follow-up was performed among patients on waiting lists for surgical treatment of varicose veins (n = 176), inguinal hernia (n = 201), and gallstones (n = 128) in 27 hospitals. Results: In each group the waiting period involved worse general health perceptions (GHPQ), more problems in quality of life (EuroQoL), and raised levels of anxiety (STAI) as compared to after surgery (all differences: p < 0.05). Quality of life was not affected in 19-36% of patients. Emotional reactions to waiting were most negative among patients with gallstones. Prior information about the duration of the wait reduced the negativity of these reactions (p < 0.05). Social activities were affected in 39% to 48% of the patients and 18%-23% of employed patients reported problems with work during the wait. Having waited a longer time was associated with worse quality of life among patients with inguinal hernia. Longer waited times also engendered more negative reactions to waiting among patients with inguinal hernia and gallstones (multilevel regression analysis, p < 0.01). Conclusion: Waiting for general surgery mainly involves a prolonged period of decreased health and an affected psychological and social life of the patient in waiting. Variation in the severity of these consequences across patients indicates that the prioritisation of patients could reduce the overall burden of waiting. Early information about the duration of the delay could further promote a patient's acceptance of waiting. [ABSTRACT FROM AUTHOR]

Background: Several studies on patient safety have shown that a substantial number of patients suffer from unintended harm caused by healthcare management in hospitals. Emergency departments (EDs) are challenging hospital settings with regard to patient safety. There is an increased sense of urgency to take effective countermeasures in order to improve patient safety. This can only be achieved if interventions tackle the dominant underlying causes. The objectives of our study are to examine the nature and causes of unintended events in EDs and the relationship between type of event and causal factor structure.Methods: Study at EDs of 10 hospitals in the Netherlands. The study period per ED was 8 to 14 weeks, in which staff were asked to report unintended events. Unintended events were broadly defined as all events, no matter how seemingly trivial or commonplace, that were unintended and could have harmed or did harm a patient. Reports were analysed with a Root Cause Analysis tool (PRISMA) by an experienced researcher.Results: 522 unintended events were reported. Of the events 25% was related to cooperation with other departments and 20% to problems with materials/equipment. More than half of the events had consequences for the patient, most often resulting in inconvenience or suboptimal care. Most root causes were human (60%), followed by organisational (25%) and technical causes (11%). Nearly half of the root causes was external, i.e. attributable to other departments in or outside the hospital.Conclusion: Event reporting gives insight into diverse unintended events. The information on unintended events may help target research and interventions to increase patient safety. It seems worthwhile to direct interventions on the collaboration between the ED and other hospital departments. [ABSTRACT FROM AUTHOR]

In many different countries the Hospital Survey on Patient Safety Culture (HSOPS) is used to assess the safety culture in hospitals. Accordingly, the questionnaire has been translated into Dutch for application in the Netherlands. The aim of this study was to examine the underlying dimensions and psychometric properties of the questionnaire in Dutch hospital settings, and to compare these results with the original questionnaire used in USA hospital settings.~Background~Background~The HSOPS was completed by 583 staff members of four general hospitals, three teaching hospitals, and one university hospital in the Netherlands. Confirmatory factor analyses were performed to examine the applicability of the factor structure of the American questionnaire to the Dutch data. Explorative factor analyses were performed to examine whether another composition of items and factors would fit the data better. Supplementary psychometric analyses were performed, including internal consistency and construct validity.~Methods~Methods~The confirmatory factor analyses were based on the 12-factor model of the original questionnaire and resulted in a few low reliability scores. 11 Factors were drawn with explorative factor analyses, with acceptable reliability scores and a good construct validity. Two items were removed from the questionnaire. The composition of the factors was very similar to that of the original questionnaire. A few items moved to another factor and two factors turned out to combine into a six-item dimension. All other dimensions consisted of two to five items.~Results~Results~The Dutch translation of the HSOPS consists of 11 factors with acceptable reliability and good construct validity. and is similar to the original HSOPS factor structure.~Conclusion~Conclusions [ABSTRACT FROM AUTHOR]

Background: Parents' reported ambivalence toward large-scale vaccination programs for childhood diseases may be related to their perception of the risks of side-effects or safety of vaccination and the risk of contracting the disease. The aim of this study is to evaluate parents' perceptions of their child's risk contracting a Meningococcal C infection and parents' perceived control in preventing infection in relation to their evaluation of the safety, effectiveness and usefulness of vaccination.Methods: In a large-scale interview study, a random sample of parents was interviewed after their children had received vaccination against Meningococcal C in a catch-up campaign. Questions were asked about the perceived relative vulnerability of their child contracting an infection, perceived control in preventing an infection, and parents' evaluation of the safety, usefulness and effectiveness of vaccination.Results: 61% of 2910 (N = 1763) parents who were approached participated. A higher perceived relative vulnerability of their own child contracting the disease was related to a more positive evaluation of the vaccination campaign, while a lower perceived vulnerability did not result in a more negative evaluation. A higher perceived control in being able to prevent an infection was, however, related to a more critical attitude toward the safety, usefulness and effectiveness of vaccination.Conclusion: Perceived relative vulnerability contracting an infection and parents' perceived control in preventing an infection seem to influence parents' evaluation of the vaccination programme. Future studies should determine if, and under which circumstances, these perceptions also affect parents' vaccination behaviour and would be relevant to be taken into account when educating parents about vaccination. [ABSTRACT FROM AUTHOR]

Background: In many countries health insurers, employers and especially governments are increasingly using pressure and coercion to enhance healthier lifestyles. For example by ever higher taxes on cigarettes and alcoholic beverages, and ever stricter smoke-free policies. Such interventions can enhance healthier behaviour, but when they become too intrusive, an unfree society can emerge. Which lifestyle interventions that use pressure or coercion are justifiable and which are not? We tried to develop an assessment model that can be used for answering this question, on a generally acceptable way, for all sorts of lifestyle interventions., Methods: The intended assessment model was developed in three phases. In the first phase the model was theoretically developed on the basis of literature study and reasoning. In the second phase the model was empirically tested by assessing two detailed cases from everyday practice using the model. The model was improved again and again. In the third phase (publication phase) the 10(th) version of the model was developed while writing this article., Results: An assessment model for the justification of intrusive lifestyle interventions. It comprises three components: (1) 12 assessment criteria (necessity, causality, responsibility, appropriate design, effectiveness, intrusiveness, burdens-benefits-ratio, fairness, support, complementary policies, verifiability, implementation capacity); (2) an assessment structure with three filters (design logic, effects and side effects, implementation); (3) a way of assessing (based on reasonableness and transparency)., Conclusions: We have developed an assessment model for the justification of lifestyle interventions that use pressure or coercion to promote health. The correctness, completeness and practicality of the model are likely. Important principles for the justification are the logic and completeness of the underlying argumentation and the proper use of the available scientific information. Parties for and against a particular intervention could use the model to test and strengthen their argumentation and to improve the quality of the intervention.

Background: An international discussion about whether or not to legally permit euthanasia and (or) physician assisted suicide (EAS) is ongoing. Unbearable suffering in patients may result in a request for EAS. In the Netherlands EAS is legally permitted, and unbearable suffering is one of the central compulsory criteria. The majority of EAS is performed in cancer patients in the primary care practice. In around one in every seven end-of-life cancer patients dying in the primary care setting EAS is performed. The prevalence of unbearable symptoms and overall unbearable suffering in relationship to explicit requests for EAS was studied in a cohort of end-of-life cancer patients in primary care., Methods: A prospective study in primary care cancer patients estimated to die within six months was performed. Every two months suffering was assessed with the State-of-Suffering V (SOS-V). The SOS-V is a comprehensive instrument for quantitative and qualitative assessment of unbearable suffering related to 69 physical, psychological and social symptoms in five domains., Results: Out of 148 patients who were asked to participate 76 (51%) entered the study. The studied population were 64 patients who were followed up until death; 27% explicitly requested EAS, which was performed in 8% of the patients. The final interview per patient was analyzed; in four patients the SOS-V was missing. Unbearable symptoms were present in 94% of patients with an explicit request for EAS and in 87% of patients without an explicit request. No differences were found in the prevalence of unbearable suffering for physical, psychological, social and existential symptoms, nor for overall unbearable suffering, between patients who did or who did not explicitly request EAS., Conclusions: In a population of end-of-life cancer patients cared for in primary care no differences in unbearable suffering were found between patients with and without explicit requests for EAS. The study raises the question whether unbearable suffering is the dominant motive to request for EAS. Most patients suffered from unbearable symptoms, indicating that the compulsory criterion of unbearable suffering may be met a priori in most end-of-life cancer patients dying at home, whether they request EAS or not.

Background: Primary care physicians provide palliative home care. In cancer patients dying at home in the Netherlands (45% of all cancer patients) euthanasia in about one out of every seven patients indicates unbearable suffering. Symptom prevalence, relationship between intensity of symptoms and unbearable suffering, evolvement of symptoms and unbearability over time and quality of unbearable suffering were studied in end-of-life cancer patients in primary care., Methods: 44 general practitioners during three years recruited cancer patients estimated to die within six months. Every two months patients quantified intensity as well as unbearability of 69 symptoms with the State-of-Suffering-V (SOS-V). Also overall unbearable suffering was quantified. The five-point rating scale ranged from 1 (not at all) to 5 (hardly can be worse). For symptoms assessed to be unbearable the nature of the suffering was additionally investigated with open-ended questions. The final interviews were analyzed; for longitudinal evolvement also the pre-final interviews were analyzed. Symptom intensity scores 4 and 5 were defined to indicate high intensity. Symptom unbearability scores 4 and 5 were defined to indicate unbearable suffering. Two raters categorized the qualitative descriptions of unbearable suffering., Results: Out of 148 requested patients 51% participated; 64 patients were followed up until death. The SOS-V was administered at least once in 60 patients (on average 30 days before death) and at least twice in 33 patients. Weakness was the most frequent unbearable symptom (57%). Pain was unbearable in 25%. Pain, loss of control over one's life and fear of future suffering frequently were unbearable (89-92%) when symptom intensity was high. Loss of control over one's life, vomiting and not being able to do important things frequently were unbearable (52-80%) when symptom intensity was low. Unbearable weakness significantly increased between pre-final and final interview. Physical suffering, loss of meaning, loss of autonomy, experiencing to be a burden, fear of future suffering and worrying more frequently occurred in patients suffering unbearably overall., Conclusions: Weakness was the most prevalent unbearable symptom in an end-of-life primary care cancer population. Physical suffering, loss of meaning and loss of autonomy more frequently occurred in patients who suffered unbearably overall.

Background: Unbearable suffering most frequently is reported in end-of-life cancer patients in primary care. However, research seldom addresses unbearable suffering. The aim of this study was to comprehensively investigate the various aspects of unbearable suffering in end-of-life cancer patients cared for in primary care., Methods: Forty four general practitioners recruited end-of-life cancer patients with an estimated life expectancy of half a year or shorter. The inclusion period was three years, follow-up lasted one additional year. Practices were monitored bimonthly to identify new cases. Unbearable aspects in five domains and overall unbearable suffering were quantitatively assessed (5-point scale) through patient interviews every two months with a comprehensive instrument. Scores of 4 (serious) or 5 (hardly can be worse) were defined unbearable. The last interviews before death were analyzed. Sources providing strength to bear suffering were identified through additional open-ended questions., Results: Seventy six out of 148 patients (51%) requested to participate consented; the attrition rate was 8%, while 8% were alive at the end of follow-up. Sixty four patients were followed up until death; in 60 patients interviews were complete. Overall unbearable suffering occurred in 28%. A mean of 18 unbearable aspects was present in patients with serious (score 4) overall unbearable suffering. Overall, half of the unbearable aspects involved the domain of traditional medical symptoms. The most frequent unbearable aspects were weakness, general discomfort, tiredness, pain, loss of appetite and not sleeping well (25%-57%). The other half of the unbearable aspects involved the domains of function, personhood, environment, and nature and prognosis of disease. The most frequent unbearable aspects were impaired activities, feeling dependent, help needed with housekeeping, not being able to do important things, trouble accepting the situation, being bedridden and loss of control (27%-55%). The combination of love and support was the most frequent source (67%) providing strength to bear suffering., Conclusions: Overall unbearable suffering occurred in one in every four end-of-life cancer patients. Half of the unbearable aspects involved medical symptoms, the other half concerned psychological, social and existential dimensions. Physicians need to comprehensively assess suffering and provide psychosocial interventions alongside physical symptom management.

Background: We need to know the scale and underlying causes of surgical adverse events (AEs) in order to improve the safety of care in surgical units. However, there is little recent data. Previous record review studies that reported on surgical AEs in detail are now more than ten years old. Since then surgical technology and quality assurance have changed rapidly. The objective of this study was to provide more recent data on the incidence, consequences, preventability, causes and potential strategies to prevent AEs among hospitalized patients in surgical units., Methods: A structured record review study of 7,926 patient records was carried out by trained nurses and medical specialist reviewers in 21 Dutch hospitals. The aim was to determine the presence of AEs during hospitalizations in 2004 and to consider how far they could be prevented. Of all AEs, the consequences, responsible medical specialty, causes and potential prevention strategies were identified. Surgical AEs were defined as AEs attributable to surgical treatment and care processes and were selected for analysis in detail., Results: Surgical AEs occurred in 3.6% of hospital admissions and represented 65% of all AEs. Forty-one percent of the surgical AEs was considered to be preventable. The consequences of surgical AEs were more severe than for other types of AEs, resulting in more permanent disability, extra treatment, prolonged hospital stay, unplanned readmissions and extra outpatient visits. Almost 40% of the surgical AEs were infections, 23% bleeding, and 22% injury by mechanical, physical or chemical cause. Human factors were involved in the causation of 65% of surgical AEs and were considered to be preventable through quality assurance and training., Conclusions: Surgical AEs occur more often than other types of AEs, are more often preventable and their consequences are more severe. Therefore, surgical AEs have a major impact on the burden of AEs during hospitalizations. These findings concur with the results from previous studies. However, evidence-based solutions to reduce surgical AEs are increasingly available. Interventions directed at human causes are recommended to improve the safety of surgical care. Examples are team training and the surgical safety checklist. In addition, specific strategies are needed to improve appropriate use of antibiotic prophylaxis and sustainable implementation of hygiene guidelines to reduce infections.

Background: Patient record review is believed to be the most useful method for estimating the rate of adverse events among hospitalised patients. However, the method has some practical and financial disadvantages. Some of these disadvantages might be overcome by using existing reporting systems in which patient safety issues are already reported, such as incidents reported by healthcare professionals and complaints and medico-legal claims filled by patients or their relatives. The aim of the study is to examine to what extent the hospital reporting systems cover the adverse events identified by patient record review., Methods: We conducted a retrospective study using a database from a record review study of 5375 patient records in 14 hospitals in the Netherlands. Trained nurses and physicians using a method based on the protocol of The Harvard Medical Practice Study previously reviewed the records. Four reporting systems were linked with the database of reviewed records: 1) informal and 2) formal complaints by patients/relatives, 3) medico-legal claims by patients/relatives and 4) incident reports by healthcare professionals. For each adverse event identified in patient records the equivalent was sought in these reporting systems by comparing dates and descriptions of the events. The study focussed on the number of adverse event matches, overlap of adverse events detected by different sources, preventability and severity of consequences of reported and non-reported events and sensitivity and specificity of reports., Results: In the sample of 5375 patient records, 498 adverse events were identified. Only 18 of the 498 (3.6%) adverse events identified by record review were found in one or more of the four reporting systems. There was some overlap: one adverse event had an equivalent in both a complaint and incident report and in three cases a patient/relative used two or three systems to complain about an adverse event. Healthcare professionals reported relatively more preventable adverse events than patients.Reports are not sensitive for adverse events nor do reports have a positive predictive value., Conclusions: In order to detect the same adverse events as identified by patient record review, one cannot rely on the existing reporting systems within hospitals.

Background: Unbearable suffering is an important issue in end-of-life decisions. However, there has been no systematic, prospective, patient-oriented research which has focused on unbearable suffering, nor is there a suitable measurement instrument. This article describes the methodological development of a quantitative instrument to measure the nature and intensity of unbearable suffering, practical aspects of its use in end-stage cancer patients in general practice, and studies content validity and psychometric properties., Methods: Recognizing the conceptual difference between unbearability of suffering and extent or intensity of suffering, we developed an instrument. The compilation of aspects considered to be of importance was based on a literature search. Psychometric properties were determined on results of the first interviews with 64 end-stage cancer patients that participated in a longitudinal study in the Netherlands., Results: The instrument measures five domains: medical signs and symptoms, loss of function, personal aspects, aspects of environment, and nature and prognosis of the disease. Sixty nine aspects were investigated, and an overall score was asked. In 64 end-stage cancer patients the instrument was used in total 153 times with an average interview time varying from 20-40 minutes. Cronbachs alpha's of the subscales were in majority above 0.7. The sum scores of (sub)scales were correlated strongly to overall measures on suffering., Conclusion: The SOS-V is an instrument for measuring the unbearability of suffering in end-stage cancer patients with good content validity and psychometric properties, which is feasible to be used in practice. This structured instrument makes it possible to identify and study unbearable suffering in a quantitative and patient-oriented way.

Background: Diagnostic error is an important error type since diagnostic adverse events are regularly judged as being preventable and the consequences are considered to be severe. Existing research often focuses on either diagnostic adverse events or on the errors in diagnostic reasoning. Whether and when an incorrect diagnostic process results in adverse outcomes has not been studied extensively. The present paper describes the design of a study that aims to study the relationship between a suboptimal diagnostic process and patient outcomes. In addition, the role of personal and circumstantial factors on the quality of the diagnostic process will be examined., Methods/design: The research questions were addressed using several data sources. First, the differential diagnosis was assessed concurrently to the diagnostic process. Second, the patient records of 248 patients suffering from shortness of breath were reviewed by expert internists in order to reveal suboptimal cognitive acts and (potential) consequences for the patient. The suboptimal cognitive acts were discussed with the treating physicians and classified with the taxonomy of unsafe acts. Third, workload, fatigue and work experience were measured during the physicians work. Workload and fatigue were measured during the physicians shift using the NASA tlx questionnaire on a handheld computer. Physicians participating in the study also answered questions about their work experience., Discussion: The design used in this study provides insight into the relationship between suboptimal cognitive acts in the diagnostic process and possible consequences for the patient. Suboptimal cognitive acts in the diagnostic process and its causes can be revealed. Additional measurements of workload, fatigue and experience allow examining the influence of these factors on the diagnostic process. In conclusion, the present design provides a method with which insights in weaknesses of the diagnostic process and the effect on patient outcomes can be studied and opportunities for improvement can be obtained.

Background: Up to now, costs attributable to adverse events (AEs) and preventable AEs in the Netherlands were unknown. We assessed the total direct medical costs associated with AEs and preventable AEs in Dutch hospitals to gain insight in opportunities for cost savings., Methods: Trained nurses and physicians retrospectively reviewed 7,926 patient records in 21 hospitals. Additional patient information of 7,889 patients was received from the Dutch registration of hospital information. Direct medical costs attributable to AEs were assessed by measuring excess length of stay and additional medical procedures after an AE occurred. Costs were valued using Dutch standardized cost prices., Results: The annual direct medical costs in Dutch hospitals were estimated at a total of euro 355 million for all AEs and euro 161 million for preventable AEs in 2004. The total number of hospital admissions in which a preventable AE occurred was 30,000 (2.3% of all admissions) and more than 300,000 (over 3% of all bed days) bed days were attributable to preventable AEs in 2004. Multilevel analysis showed that variance in direct medical costs was not determined by differences between hospitals or hospital departments., Conclusion: The estimates of the total preventable direct medical costs of AEs indicate that they form a substantial part (1%) of the expenses of the national health care budget and are of importance to hospital management. The cost driver of the direct medical costs is the excess length of stay (including readmissions) in a hospital. Insight in which determinants are associated with high preventable costs will offer useful information for policymakers and hospital management to determine starting points for interventions to reduce the costs of preventable AEs.

Background: Medical students develop interest in a specialty career during medical school based on knowledge and clinical experience of different specialties. How valid this knowledge is and how this knowledge relates to the development of preference for a specialty is not known. We studied their "subjective" knowledge of a specialty (students' reported knowledge) with "objective" knowledge of it (students actual knowledge as compared to reports of specialists) and their preference for this specialty at different stages of education, and used youth health care as a case study., Methods: Students from all years in two medical schools (N = 2928) were asked to complete a written questionnaire including (a) a statement of their knowledge of youth health care (YHC) ("subjective knowledge"), (b) their preference for a YHC career and (c) a list of 47 characteristics of medical practice with the request to rate their applicability to YHC. A second questionnaire containing the same 47 characteristics were presented to 20 practicing youth health physicians with the request to rate the applicability to their own profession. This profile was compared to the profiles generated by individual student's answers, resulting in what we called "objective knowledge.", Results: Correlation studies showed that "subjective knowledge" was not related to "objective knowledge" of the YHC profession (r = 0.05), but significantly to career preference for this field (r = 0.29, P < 0.01). Preference for a YHC career hardly correlated with objective knowledge about this profession (r = 0.11, P < 0.05). Students with YHC clerkships showed no better "objective knowledge" about the profession than students without such experience., Conclusion: Career preference aren't always related to prior experiences, or to actual knowledge of the area. This study shows how careful we should be to trust students' opinions and preferences about specialties; they probably need much guidance in career choice.

Background: Systematic and reliable epidemiological information at population level, preferably cross-national, is needed for an adequate planning of (end-of-life) health care policies, e.g. concerning place of death, but is currently lacking. This study illustrates opportunities and weaknesses of death certificate data to provide such information on place of death and associated factors in nine European countries (seven entire countries and five regions)., Methods: We investigated the possibility and modality of all partners in this international comparative study (BE, DK, IT, NL, NO, SE, UK) to negotiate a dataset containing all deaths of one year with their national/regional administration of mortality statistics, and analysed the availability of information about place of death as well as a number of clinical, socio-demographic, residential and healthcare system factors., Results: All countries negotiated a dataset, but rules, procedures, and cost price to get the data varied strongly between countries. In total, about 1.1 million deaths were included. For four of the nine countries not all desired categories for place of death were available. Most desired clinical and socio-demographic information was available, be it sometimes via linkages with other population databases. Healthcare system factors could be made available by linking existing healthcare statistics to the residence of the deceased., Conclusion: Death certificate data provide information on place of death and on possibly associated factors and confounders in all studied countries. Hence, death certificate data provide a unique opportunity for cross-national studying and monitoring of place of death. However, modifications of certain aspects of death certificate registration and rules of data-protection are perhaps required to make international monitoring of place of death more feasible and accurate.

Background: Problematic waiting lists in public health care threaten the equity and timeliness of care provision in several countries. This study assesses different stakeholders' views on the acceptability of waiting lists in health care, their preferences for priority care of patients, and their judgements on acceptable waiting times for surgical patients., Methods: A questionnaire survey was conducted among 257 former patients (82 with varicose veins, 86 with inguinal hernia, and 89 with gallstones), 101 surgeons, 95 occupational physicians, and 65 GPs. Judgements on acceptable waiting times were assessed using vignettes of patients with varicose veins, inguinal hernia, and gallstones., Results: Participants endorsed the prioritisation of patients based on clinical need, but not on ability to benefit. The groups had significantly different opinions (p < 0.05) on the use of non-clinical priority criteria and on the need for uniformity in the prioritisation process. Acceptable waiting times ranged between 2 and 25 weeks depending on the type of disorder (p < 0.001) and the severity of physical and psychosocial problems of patients (p < 0.001). Judgements were similar between the survey groups (p = 0.3) but responses varied considerably within each group depending on the individual's attitude towards waiting lists in health care (p < 0.001)., Conclusion: The explicit prioritisation of patients seems an accepted means for reducing the overall burden from waiting lists. The disagreement about appropriate prioritisation criteria and the need for uniformity, however, raises concern about equity when implementing prioritisation in daily practice. Single factor waiting time thresholds seem insufficient for securing timely care provision in the presence of long waiting lists as they do not account for the different consequences of waiting between patients.

Background: Various international studies have shown that a substantial number of patients suffer from injuries or even die as a result of care delivered in hospitals. The occurrence of injuries among patients caused by health care management in Dutch hospitals has never been studied systematically. Therefore, an epidemiological study was initiated to determine the incidence, type and impact of adverse events among discharged and deceased patients in Dutch hospitals., Methods/design: Three stage retrospective patient record review study in 21 hospitals of 8400 patient records of discharged or deceased patients in 2004. The records were reviewed by trained nurses and physicians between August 2005 and October 2006. In addition to the determination of presence, the degree of preventability, and causes of adverse events, also location, timing, classification, and most responsible specialty of the adverse events were measured. Moreover, patient and admission characteristics and the quality of the patient records were recorded., Discussion: In this paper we report on the design of the retrospective patient record study on the occurrence of adverse events in Dutch hospitals. Attention is paid to the strengths and limitations of the study design. Furthermore, alterations made in the original research protocol in comparison with former international studies are described in detail.