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BACKGROUND: Audits are increasingly used for patient safety governance purposes. However, there is little insight into the factors that hinder or stimulate effective governance based on auditing. The aim of this study is to quantify the factors that influence effective auditing for hospital boards and executives.METHODS: A questionnaire of 32 factors was developed using influencing factors found in a qualitative study on effective auditing. Factors were divided into four categories. The questionnaire was sent to the board of directors, chief of medical staff, nursing officer, medical department head and director of the quality and safety department of 89 acute care hospitals in the Netherlands.RESULTS: We approached 522 people, of whom 211 responded. Of the 32 factors in the questionnaire, 30 factors had an agreement percentage higher than 50%. Important factors per category were 'audit as an improvement tool as well as a control tool', 'department is aware of audit purpose', 'quality of auditors' and 'learning culture at department'. We found 14 factors with a significant difference in agreement between stakeholders of at least 20%. Amongst these were 'medical specialist on the audit team', 'soft signals in the audit report', 'patients as auditors' and 'post-audit support'.CONCLUSION: We found 30 factors for effective auditing, which we synthesised into eight recommendations to optimise audits. Hospitals can use these recommendations as a framework for audits that enable boards to become more in control of patient safety in their hospital.

__Objectives__ Hospital boards are legally responsible for safe healthcare. They need tools to assist them in their task of governing patient safety. Almost every Dutch hospital performs internal audits, but the effectiveness of these audits for hospital governance has never been evaluated. The aim of this study is to evaluate the organisation of internal audits and their effectiveness for hospitals boards to govern patient safety. __Design and setting__ A mixed-methods study consisting of a questionnaire regarding the organisation of internal audits among all Dutch hospitals (n=89) and interviews with stakeholders regarding the audit process and experienced effectiveness of audits within six hospitals. __Results__ Response rate of the questionnaire was 76% and 43 interviews were held. In every responding hospital, the internal audits followed the plan–do–check–act cycle. Every hospital used interviews, document analysis and site visits as input for the internal audit. Boards stated that effective aspects of internal audits were their multidisciplinary scope, their structured and indepth approach, the usability to monitor improvement activities and to change hospital policy and the fact that results were used in meetings with staff and boards of supervisors. The qualitative methods (interviews and site visits) used in internal audits enable the identification of soft signals such as unsafe culture or communication and collaboration problems. Reported disadvantages were the low frequency of internal audits and the absence of soft signals in the actual audit reports. __Conclusion__ This study shows that internal audits are regarded as effective for patient safety governance, as they help boards to identify patient safety problems, proactively steer patient safety and inform boards of supervisors on the status of patient safety. The description of the Dutch internal audits makes these audits replicable to other healthcare organisations in different settings, enabling h

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Background: Five to 22 % of the adult Western population has gallstones. Among them, 13 to 22 % become symptomatic during their lifetime. Cholecystectomy is the preferred treatment for symptomatic cholecystolithiasis. Remarkably, cholecystectomy provides symptom relief in only 60-70 % of patients. The objective of this trial is to compare the effectiveness of usual (operative) care with a restrictive strategy using a standardized work-up with stepwise selection for cholecystectomy in patients with gallstones and abdominal complaints.Design and methods: The SECURE-trial is designed as a multicenter, randomized, parallel-arm, non-inferiority trial in patients with abdominal symptoms and ultrasound proven gallstones or sludge. If patients meet the inclusion criteria they will be randomized to either usual care or the restrictive strategy. Patients in the usual care group will be treated according to the physician's knowledge and preference. Patients in the restrictive care group will be treated with interval evaluation and stepwise selection for laparoscopic cholecystectomy. In this stepwise selection, patients strictly meeting the preselected criteria for symptomatic cholecystolithiasis will be offered a cholecystectomy. Patients not meeting these criteria will be assessed for other diagnoses and re-evaluated at 3-monthly intervals. Follow-up consists of web-based questionnaires at 3, 6, 9 and 12 months. The main end point of this trial is defined as the proportion of patients being pain-free at 12 months follow-up. Pain will be assessed with the Izbicki Pain Score and Gallstone Symptom Score. Secondary endpoints will be the proportion of patients with complications due to gallstones or cholecystectomy, the association between the patients' symptoms and treatment and work performance, and ultimately, cost-effectiveness.Discussion: The SECURE trial is the first randomized controlled trial examining the effectiveness of usual care v

Objective It is known that doctors who receive complaints may have feelings of anger, guilt, shame and depression, both in the short and in the long term. This might lead to functional impairment. Less is known about the impact of the disciplinary process and imposed measures. Previous studies of disciplinary proceedings have mainly focused on identifying characteristics of disciplined doctors and on sentencing policies. Therefore, the aim of this study is to explore what impact the disciplinary process and imposed measures have on healthcare professionals. Design Semistructured interview study, with purposive sampling and inductive qualitative content analysis. Participants 16 healthcare professionals (9 medical specialists, 3 general practitioners, 2 physiotherapists and 2 psychologists) that were sanctioned by the disciplinary tribunal. Setting The Netherlands. Results Professionals described feelings of misery and insecurity both during the process as in its aftermath. Furthermore, they reported to fear receiving new complaints and provide care more cautiously after the imposed measure. Factors that may enhance psychological and professional impact are the publication of measures online and in newspapers, media coverage, the feeling of treated as guilty before any verdict has been reached, and the long duration of the process. Conclusions This study shows that the disciplinary process and imposed measures can have a profound psychological and professional impact on healthcare professionals. Although a disciplinary measure is meant to have a corrective effect, our results suggest that the impact that is experienced by professionals might hamper optimal rehabilitation afterwards. Therefore, organising emotional support should be considered during the disciplinary process and in the period after the verdict. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to d

Contains fulltext : 139048.pdf (publisher's version ) (Open Access), BACKGROUND: Aneurysmal subarachnoid hemorrhage (aSAH) is a condition affecting relatively young patients and has high rates of morbidity and mortality. Online health communities have emerged to fill the void for patient advocacy and information, allowing individuals with shared experiences and chronic disorders to connect. OBJECTIVE: We have developed an online health community for aSAH patients, and this pilot study was conducted to evaluate it from a patient's perspective. METHODS: We implemented an online, members-only, health community (MijnSAB, translation: MySAH) in addition to the usual aSAH care at Radboudumc, Nijmegen, the Netherlands. A questionnaire that was sent to consecutive aSAH patients was used to evaluate the usability and utility of MySAH. Answers were provided using a 5-point Likert scale. There was also one open-ended question asking about what was missing from the MySAH tool. RESULTS: In total, 66 consecutive patients with aneurysmal subarachnoid hemorrhage were informed about the online health community. Of 64 potential MySAH users, 26 patients gained access to MySAH, 20 of whom were willing to participate in the evaluation. Those who used the community were younger (P=.03) and in a better condition at discharge (P=.03). The patients were positive about MySAH's contribution to the quality of their care, but not to their quality of life. Most patients (18/20, 90%) reported that they would recommend the community to others in their position. Open suggestions on how to improve the tool included more frequent blogs, including by a rehabilitation specialist. CONCLUSIONS: This pilot study showed that the online health community, MySAH, has a beneficial effect on the aftercare of patients suffering from aSAH because it gives easy access to relevant information provided by peers or caregivers. Due to the variable clinical outcomes after aSAH, the tool will mainly be useful for a select group of patients (with a better clinical outcome).

Item does not contain fulltext, BACKGROUND: Regularly, patients are not involved in development of evaluative tools. Investigators define outcomes according to their interests. These can be different with those of the patients. Therefore, it may be difficult for patients to choose between treatment options, because the outcomes' measurements may not reflect their problems in daily life. Most ideally, patients are involved from the beginning in the development of an outcome measurement tool. In this study, a new concept was demonstrated in which a questionnaire was developed in collaboration with patients to evaluate the quality of surgical care of a frequently encountered entity (carpal tunnel syndrome) that is meaningful for and understandable by patients. METHODS: Through a patient participatory research in an academic hospital, 50 consecutive patients who recently underwent surgical decompression of carpal tunnel syndrome were asked to optimize a questionnaire. An existing questionnaire was sent to the patients with the request to grade the relevance of each question. They were also offered the possibility to add questions from their point of view. RESULTS: All questions were found relevant. Finally, the questionnaire was modified by adding one question proposed by the patients. They wanted to include a question that would evaluate the effect of the treatment. Therefore, a question was introduced to evaluate the effect of the surgery on the symptoms and signs with a six-item Likert scale varying from severely worsened to free of signs and symptoms. Finally, the EQ-5D-5 L was added as a measure of quality of life. CONCLUSIONS: The participation of patients is essential but until now not usual when a tool for evaluating the success of a treatment is developed. Information that is meaningful for patients but not obligate for researchers can easily be missed in the classical development of outcome measurement tools. This information will be crucial when future patients try to understand the finding

Contains fulltext : 155671.pdf (publisher's version ) (Open Access), OBJECTIVES: To investigate whether a priori selection of patient records using unexpectedly long length of stay (UL-LOS) leads to detection of more records with adverse events (AEs) compared to non-UL-LOS. DESIGN: To investigate the opportunities of the UL-LOS, we looked for AEs in all records of patients with colorectal cancer. Within this group, we compared the number of AEs found in records of patients with a UL-LOS with the number found in records of patients who did not have a UL-LOS. SETTING: Our study was done at a general hospital in The Netherlands. The hospital is medium sized with approximately 30 000 admissions on an annual basis. The hospital has two major locations in different cities where both primary and secondary care is provided. PARTICIPANTS: The patient records of 191 patients with colorectal cancer were reviewed. PRIMARY AND SECONDARY OUTCOME MEASURES: Number of triggers and adverse events were the primary outcome measures. RESULTS: In the records of patients with colorectal cancer who had a UL-LOS, 51% of the records contained one or more AEs compared with 9% in the reference group of non-UL-LOS patients. By reviewing only the UL-LOS group with at least one trigger, we found in 84% (43 out of 51) of these records at least one adverse event. CONCLUSIONS: A priori selection of patient records using the UL-LOS indicator appears to be a powerful selection method which could be an effective way for healthcare professionals to identify opportunities to improve patient safety in their day-to-day work.

Background: The validity, reliability and cross-country comparability of summary measures of population health (SMPH) have been persistently debated. In this debate, the measurement and valuation of nonfatal health outcomes have been defined as key issues. Our goal was to quantify and decompose international differences in health expectancy based on health-related quality of life (HRQoL). We focused on the impact of value set choice on cross-country variation. Methods: We calculated Quality Adjusted Life Expectancy (QALE) at age 20 for 15 countries in which EQ-5D population surveys had been conducted. We applied the Sullivan approach to combine the EQ-5D based HRQoL data with life tables from the Human Mortality Database. Mean HRQoL by country-gender-age was estimated using a parametric model. We used nonparametric bootstrap techniques to compute confidence intervals. QALE was then compared across the six country-specific time trade-off value sets that were available. Finally, three counterfactual estimates were generated in order to assess the contribution of mortality, health states and health-state values to cross-country differences in QALE. Results: QALE at age 20 ranged from 33 years in Armenia to almost 61 years in Japan, using the UK value set. The value sets of the other five countries generated different estimates, up to seven years higher. The relative impact of choosing a different value set differed across country-gender strata between 2% and 20%. In 50% of the country-gender strata the ranking changed by two or more positions across value sets. The decomposition demonstrated a varying impact of health states, health-state values, and mortality on QALE differences across countries. Conclusions: The choice of the value set in SMPH may seriously affect cross-country comparisons of health expectancy, even across populations of similar levels of wealth and education. In our opinion, it is essential to get more insight into the drivers of differences in heal

Background. Indicators of hospital quality, such as hospital standardized mortality ratios (HSMR), have been used increasingly to assess and improve hospital quality. Our aim has been to describe and explain variation in new HSMRs for the Netherlands. Methods. HSMRs were estimated using data from the complete population of discharged patients during 2003 to 2005. We used binary logistic regression to indirectly standardize for differences in case-mix. Out of a total of 101 hospitals 89 hospitals remained in our explanatory analysis. In this analysis we explored the association between HSMRs and determinants that can and cannot be influenced by hospitals. For this analysis we used a two-level hierarchical linear regression model to explain variation in yearly HSMRs. Results. The average HSMR decreased yearly with more than eight p