Estimating the impact of stimulant use on initiation of buprenorphine and extended-release naltrexone in two clinical trials and real-world populations.

BACKGROUND: Co-use of stimulants and opioids is rapidly increasing. Randomized clinical trials (RCTs) have established the efficacy of medications for opioid use disorder (MOUD), but stimulant use may decrease the likelihood of initiating MOUD treatment. Furthermore, trial participants may not represent "real-world" populations who would benefit from treatment. METHODS: We conducted a two-stage analysis. First, associations between stimulant use (time-varying urine drug screens for cocaine, methamphetamine, or amphetamines) and initiation of buprenorphine or extended-release naltrexone (XR-NTX) were estimated across two RCTs (CTN-0051 X:BOT and CTN-0067 CHOICES) using adjusted Cox regression models. Second, results were generalized to three target populations who would benefit from MOUD: Housed adults identifying the need for OUD treatment, as characterized by the National Survey on Drug Use and Health (NSDUH); adults entering OUD treatment, as characterized by Treatment Episodes Dataset (TEDS); and adults living in rural regions of the U.S. with high rates of injection drug use, as characterized by the Rural Opioids Initiative (ROI). Generalizability analyses adjusted for differences in demographic characteristics, substance use, housing status, and depression between RCT and target populations using inverse probability of selection weighting. RESULTS: Analyses included 673 clinical trial participants, 139 NSDUH respondents (weighted to represent 661,650 people), 71,751 TEDS treatment episodes, and 1,933 ROI participants. The majority were aged 30-49 years, male, and non-Hispanic White. In RCTs, stimulant use reduced the likelihood of MOUD initiation by 32% (adjusted HR [aHR] = 0.68, 95% CI 0.49-0.94, p = 0.019). Stimulant use associations were slightly attenuated and non-significant among housed adults needing treatment (25% reduction, aHR = 0.75, 0.48-1.18, p = 0.215) and adults entering OUD treatment (28% reduction, aHR = 0.72, 0.51-1.01, p = 0.061). The association was more pronounced, but still non-significant among rural people injecting drugs (39% reduction, aHR = 0.61, 0.35-1.06, p = 0.081). Stimulant use had a larger negative impact on XR-NTX initiation compared to buprenorphine, especially in the rural population (76% reduction, aHR = 0.24, 0.08-0.69, p = 0.008). CONCLUSIONS: Stimulant use is a barrier to buprenorphine or XR-NTX initiation in clinical trials and real-world populations that would benefit from OUD treatment. Interventions to address stimulant use among patients with OUD are urgently needed, especially among rural people injecting drugs, who already suffer from limited access to MOUD.

The role of dwelling type when estimating the effect of magnetic fields on childhood leukemia in the California Power Line Study (CAPS).

PURPOSE: The type of dwelling where a child lives is an important factor when considering residential exposure to environmental agents. In this paper, we explore its role when estimating the potential effects of magnetic fields (MF) on leukemia using data from the California Power Line Study (CAPS). In this context, dwelling type could be a risk factor, a proxy for other risk factors, a cause of MF exposure, a confounder, an effect-measure modifier, or some combination. METHODS: We obtained information on type of dwelling at birth on over 2,000 subjects. Using multivariable-adjusted logistic regression, we assessed whether dwelling type was a risk factor for childhood leukemia, which covariates and MF exposures were associated with dwelling type, and whether dwelling type was a potential confounder or an effect-measure modifier in the MF-leukemia relationship under the assumption of no-uncontrolled confounding. RESULTS: A majority of children lived in single-family homes or duplexes (70%). Dwelling type was associated with race/ethnicity and socioeconomic status but not with childhood leukemia risk, after other adjustments, and did not alter the MF-leukemia relationship upon adjustment as a potential confounder. Stratification revealed potential effect-measure modification by dwelling type on the multiplicative scale. CONCLUSION: Dwelling type does not appear to play a significant role in the MF-leukemia relationship in the CAPS dataset as a leukemia risk factor or confounder. Future research should explore the role of dwelling as an effect-measure modifier of the MF-leukemia association.

Parental time to pregnancy, medically assisted reproduction and pubertal development in boys and girls.

STUDY QUESTION: Does parental fertility, measured by time to pregnancy (TTP), or use of medically assisted reproduction (MAR) affect pubertal development in the offspring? SUMMARY ANSWER: Neither TTP nor type of MAR treatment had clinically relevant implications for mean age at achieving individual pubertal milestones or overall timing of puberty in boys and girls. WHAT IS KNOWN ALREADY: Parental TTP and MAR have been associated with impaired semen quality in adult sons. Timing of puberty reflects earlier signals of reproductive health, but it remains unclear whether parental fertility or MAR affects pubertal development, especially in the growing generation of children conceived by IVF or ICSI. STUDY DESIGN, SIZE, DURATION: In this study, 15 819 children born by mothers in the Danish National Birth Cohort from 2000 to 2003 participated in a nationwide puberty cohort (participation rate = 70%). Parental TTP and use of MAR were reported by mothers in early pregnancy and children's pubertal development data was self-recorded in web-based questionnaires from 11 years of age and 6 monthly throughout puberty (2012-2018). PARTICIPANTS/MATERIALS, SETTING, METHODS: Pubertal development in children (of planned pregnancies, n = 13 285) born by untreated subfecund (TTP: 6-12 months) (n =2038), untreated severely subfeund (TTP: >12 months) (n = 1242), treated subfecund (n = 230) and treated severely subfecund (n = 1234) parents were compared to children born to more fertile parents (TTP: ≤5 months). We estimated mean monthly differences in mean age at achieving individual pubertal milestones (i.e. age at menarche, voice break, first ejaculation and Tanner stages 2, 3, 4 and 5 for breast or genital development and pubic hair growth) and a combined indicator of timing of puberty. Further, we compared mean age at achieving the individual pubertal milestones in children born by use of IVF or ICSI (n = 480) with children born by controlled ovarian stimulation or ovulation induction with or without intrauterine insemination (n = 902). MAIN RESULTS AND THE ROLE OF CHANCE: We found tendencies towards slightly later mean age at male pubertal timing and slightly earlier mean age at female pubertal timing among children born by untreated subfecund, treated subfecund, untreated severely subfecund and treated severely subfecund parents. There were no specific patterns with increasing TTP, use of MAR nor type of MAR treatment, and the magnitude of the mean differences for individual milestones and overall timing of puberty were small, i.e. 0.9 months (95% CI: -1.0; 2.8) for first ejaculation and -0.5 months (95% CI: -2.0; 1.0) months for age at menarche in boys and girls, respectively, born by treated severely subfecund parents when compared with children born by more fertile parents. LIMITATIONS, REASONS FOR CAUTION: Non-differential misclassification of the self-reported information on parental TTP and pubertal development in the offspring may serve as an alternative explanation of the findings, possibly biasing the estimates towards the null. The information on pubertal development was collected from around 11 years of age and onwards. WIDER IMPLICATIONS OF THE FINDINGS: This study adds to the growing body of literature suggesting only limited harmful effects of parental subfecundity and MAR on offspring's long-term growth and development. STUDY FUNDING/COMPETING INTEREST(S): This work was supported by the Danish Council for Independent Research [DFF 4183-00152]; and the Faculty of Health at Aarhus University. The authors have no financial relationships or competing interests to disclose.

Residential mobility and childhood leukemia.

AIMS: Studies of environmental exposures and childhood leukemia studies do not usually account for residential mobility. Yet, in addition to being a potential risk factor, mobility can induce selection bias, confounding, or measurement error in such studies. Using data collected for California Powerline Study (CAPS), we attempt to disentangle the effect of mobility. METHODS: We analyzed data from a population-based case-control study of childhood leukemia using cases who were born in California and diagnosed between 1988 and 2008 and birth certificate controls. We used stratified logistic regression, case-only analysis, and propensity-score adjustments to assess predictors of residential mobility between birth and diagnosis, and account for potential confounding due to residential mobility. RESULTS: Children who moved tended to be older, lived in housing other than single-family homes, had younger mothers and fewer siblings, and were of lower socioeconomic status. Odds ratios for leukemia among non-movers living <50 meters (m) from a 200+ kilovolt line (OR: 1.62; 95% CI: 0.72-3.65) and for calculated fields ≥ 0.4 microTesla (OR: 1.71; 95% CI: 0.65-4.52) were slightly higher than previously reported overall results. Adjustments for propensity scores based on all variables predictive of mobility, including dwelling type, increased odds ratios for leukemia to 2.61 (95% CI: 1.76-3.86) for living < 50 m from a 200 + kilovolt line and to 1.98 (1.11-3.52) for calculated fields. Individual or propensity-score adjustments for all variables, except dwelling type, did not materially change the estimates of power line exposures on childhood leukemia. CONCLUSION: The residential mobility of childhood leukemia cases varied by several sociodemographic characteristics, but not by the distance to the nearest power line or calculated magnetic fields. Mobility appears to be an unlikely explanation for the associations observed between power lines exposure and childhood leukemia.

Validity of police contacts as a performance indicator for the public mental health care system in Amsterdam: an open cohort study.

PURPOSE: The Public Mental Health Care (PMHC) system is a network of public services and care- and support institutions financed from public funds. Performance indicators based on the registration of police contacts could be a reliable and useful source of information for the stakeholders of the PMHC system to monitor performance. This study aimed to provide evidence on the validity of using police contacts as a performance indicator to assess the continuity of care in the PMHC system. METHODS: Data on services received, police contacts and detention periods of 1928 people that entered the PMHC system in the city of Amsterdam were collected over a period of 51 months. Continuity of care was defined as receiving more than 90 days of uninterrupted service. The associations between police contacts and continuity were analyzed with multilevel Poisson and multivariate linear regression modeling. RESULTS: Clients had on average 2.12 police contacts per person-year. Clients with police contacts were younger, more often single, male, and more often diagnosed with psychiatric or substance abuse disorders than clients without police contacts. Incidence rates of police contacts were significantly lower for clients receiving continuous care than for clients receiving discontinuous care. The number of police contacts of clients receiving PMHC coordination per month was found to be a significant predictor of the percentage of clients in continuous care. CONCLUSION: The number of police contacts of clients can be used as a performance indicator for an urban PMHC system to evaluate the continuity of care in the PMHC system.

Weight gain during incarceration: systematic review and meta-analysis.

BACKGROUND: Existing evidence suggests that the prevalence of overweight and obesity among prisoners in different settings is high. Evaluating weight change during incarceration would allow for the investigation of whether the prison environment indeed contributes to unfavourable weight changes. OBJECTIVES: This study aimed to do a systematic review and a meta-analysis of existing evidence regarding weight change during incarceration. METHODS AND RESULTS: We conducted a systematic literature search by using five different online databases and included grey literature. A total of 16 studies, all conducted in developed countries, were identified. Weight change was computed in 11 of these studies and was self-reported in five studies. Only two studies included youth. In all but 1 of the 11 studies using actual assessment of weight change, there was an increase in body weight or body mass index on average or weight gain occurred among a significant proportion of participants. A meta-analysis of eight of these studies showed an average weight gain of 0.43 (95% CI 0.14, 0.72) lb/week. In all studies including perceived weight change, a high proportion (43% to 73%) of participants reported weight gain during incarceration. CONCLUSION: Health promotion activities within prisons should incorporate initiatives aimed at combating unhealthy weight developments.

Mediators of socioeconomic differences in adiposity among youth: a systematic review.

BACKGROUND: Youth with a low socioeconomic position in developed countries are at a disproportionately higher risk of being overweight or obese than their counterparts. Tackling these inequalities requires that the mechanisms behind them are well understood. OBJECTIVES: The aim of this review was to summarize existing evidence regarding the factors that mediate or contribute to the explanation of the relationship between socioeconomic position and adiposity among youth. METHODS AND RESULTS: A systematic literature search, conducted using the databases Medline, Embase, Web of Science and PsycINFO, yielded 28 eligible studies. These studies were of low to moderate methodological quality. The most consistent mediators of the association between socioeconomic position and adiposity identified in this review were as follows: consumption of sugar-sweetened beverages, television viewing, computer use, parental body mass index, breastfeeding duration, breakfast consumption, maternal smoking during pregnancy and infant feeding practices. The mediating role of physical activity as well as fruit and vegetable consumption was found to be indeterminate. Other potential mediators were explored in too few studies to make conclusions about their mediating role. CONCLUSION: The review found several modifiable factors that could be targeted as feasible in interventions aimed at reducing socioeconomic differences in overweight and obesity among youth.

Development and validation of an index to assess hospital quality management systems.

OBJECTIVE: The aim of this study was to develop and validate an index to assess the implementation of quality management systems (QMSs) in European countries. DESIGN: Questionnaire development was facilitated through expert opinion, literature review and earlier empirical research. A cross-sectional online survey utilizing the questionnaire was undertaken between May 2011 and February 2012. We used psychometric methods to explore the factor structure, reliability and validity of the instrument. SETTING AND PARTICIPANTS: As part of the Deepening our Understanding of Quality improvement in Europe (DUQuE) project, we invited a random sample of 188 hospitals in 7 countries. The quality managers of these hospitals were the main respondents. MAIN OUTCOME MEASURE: The extent of implementation of QMSs. RESULTS: Factor analysis yielded nine scales, which were combined to build the Quality Management Systems Index. Cronbach's reliability coefficients were satisfactory (ranging from 0.72 to 0.82) for eight scales and low for one scale (0.48). Corrected item-total correlations provided adequate evidence of factor homogeneity. Inter-scale correlations showed that every factor was related, but also distinct, and added to the index. Construct validity testing showed that the index was related to recent measures of quality. Participating hospitals attained a mean value of 19.7 (standard deviation of 4.7) on the index that theoretically ranged from 0 to 27. CONCLUSION: Assessing QMSs across Europe has the potential to help policy-makers and other stakeholders to compare hospitals and focus on the most important areas for improvement.

The associations between organizational culture, organizational structure and quality management in European hospitals.

OBJECTIVE: To better understand associations between organizational culture (OC), organizational management structure (OS) and quality management in hospitals. DESIGN: A multi-method, multi-level, cross-sectional observational study. SETTING AND PARTICIPANTS: As part of the DUQuE project (Deepening our Understanding of Quality improvement in Europe), a random sample of 188 hospitals in 7 countries (France, Poland, Turkey, Portugal, Spain, Germany and Czech Republic) participated in a comprehensive questionnaire survey and a one-day on-site surveyor audit. Respondents for this study (n = 158) included professional quality managers and hospital trustees. MAIN OUTCOME MEASURES: Extent of implementation of quality management systems, extent of compliance with existing management procedures and implementation of clinical quality activities. RESULTS: Among participating hospitals, 33% had a clan culture as their dominant culture type, 26% an open and developmental culture type, 16% a hierarchical culture type and 25% a rational culture type. The culture type had no statistically significant association with the outcome measures. Some structural characteristics were associated with the development of quality management systems. CONCLUSION: The type of OC was not associated with the development of quality management in hospitals. Other factors (not culture type) are associated with the development of quality management. An OS that uses fewer protocols is associated with a less developed quality management system, whereas an OS which supports innovation in care is associated with a more developed quality management system.

The use of on-site visits to assess compliance and implementation of quality management at hospital level.

OBJECTIVE: Stakeholders of hospitals often lack standardized tools to assess compliance with quality management strategies and the implementation of clinical quality activities in hospitals. Such assessment tools, if easy to use, could be helpful to hospitals, health-care purchasers and health-care inspectorates. The aim of our study was to determine the psychometric properties of two newly developed tools for measuring compliance with process-oriented quality management strategies and the extent of implementation of clinical quality strategies at the hospital level. DESIGN: We developed and tested two measurement instruments that could be used during on-site visits by trained external surveyors to calculate a Quality Management Compliance Index (QMCI) and a Clinical Quality Implementation Index (CQII). We used psychometric methods and the cross-sectional data to explore the factor structure, reliability and validity of each of these instruments. SETTING AND PARTICIPANTS: The sample consisted of 74 acute care hospitals selected at random from each of 7 European countries. MAIN OUTCOME MEASURES: The psychometric properties of the two indices (QMCI and CQII). RESULTS: Overall, the indices demonstrated favourable psychometric performance based on factor analysis, item correlations, internal consistency and hypothesis testing. Cronbach's alpha was acceptable for the scales of the QMCI (α: 0.74-0.78) and the CQII (α: 0.82-0.93). Inter-scale correlations revealed that the scales were positively correlated, but distinct. All scales added sufficient new information to each main index to be retained. CONCLUSION: This study has produced two reliable instruments that can be used during on-site visits to assess compliance with quality management strategies and implementation of quality management activities by hospitals in Europe and perhaps other jurisdictions.

Feasibility of using administrative data to compare hospital performance in the EU.

OBJECTIVE: To describe hospitals' organizational arrangements relevant to the abstraction of administrative data, to report on the completeness of administrative data collected and to assess associations between organizational arrangements and completeness of data submission. DESIGN: A cross-sectional STUDY DESIGN: utilizing administrative data. SETTING AND PARTICIPANTS: Randomly selected hospitals from seven European countries (The Czech Republic, France, Germany, Poland, Portugal, Spain, and Turkey). MAIN OUTCOME MEASURES: Completeness of data submission for four quality indicators: mortality after acute myocardial infarction, stroke and hip fractures and complications after normal delivery. RESULTS: In general, hospitals were able to produce data on the four indicators required for this research study. A substantial proportion had missing data on one or more data items. The proportion of hospitals that was able to produce more detailed indicators of relevance for quality monitoring and improvement was low and ranged from 40.1% for thrombolysis performed on patients with acute ischemic stroke to 63.8% for hip-fracture operations performed within 48 h after admission for patients aged 65 or older. National factors were strong predictors of data completeness on the studied indicators. CONCLUSIONS: At present, hospital administrative databases do not seem to be an appropriate source of information for comparison of hospital performance across the countries of the EU. However, given that this is a dynamic field, changes to administrative databases may make this possible in the near future. Such changes could be accelerated by an in-depth comparative analysis of the issues of using administrative data for comparisons of hospital performances in EU countries.

Is having quality as an item on the executive board agenda associated with the implementation of quality management systems in European hospitals: a quantitative analysis.

OBJECTIVE: To assess whether there is a relationship between having quality as an item on the board's agenda, perceived external pressure (PEP) and the implementation of quality management in European hospitals. DESIGN: A quantitative, mixed method, cross-sectional study in seven European countries in 2011 surveying CEOs and quality managers and data from onsite audits. PARTICIPANTS: One hundred and fifty-five CEOs and 155 quality managers. SETTING: One hundred and fifty-five randomly selected acute care hospitals in seven European countries (Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey). Main outcome measure(s) Three constructs reflecting quality management based on questionnaire and audit data: (i) Quality Management System Index, (ii) Quality Management Compliance Index and (iii) Clinical Quality Implementation Index. The main predictor was whether quality performance was on the executive board's agenda. RESULTS: Discussing quality performance at executive board meetings more often was associated with a higher quality management system score (regression coefficient b = 2.53; SE = 1.16; P = 0.030). We found a trend in the associations of discussing quality performance with quality compliance and clinical quality implementation. PEP did not modify these relationships. CONCLUSIONS: Having quality as an item on the executive board's agenda allows them to review and discuss quality performance more often in order to improve their hospital's quality management. Generally, and as this study found, having quality on the executive board's agenda matters.

Factors associated with HIV infection among Indian women.

There is still a paucity of research on the sociodemographic and other underlying factors associated with HIV transmission among women in India. This study was designed to investigate such factors in sexually experienced Indian women. We used data from the National Family Health Survey 3 (NFHS-3), which tested 52,853 women for HIV, including 27,556 husband and wife pairs. Significant risk factors for all women and married women only were: aged 26-35 years (adjusted odds ratios [AORs] = 3.65 and 2.53, respectively), being poor (AORs = 1.57 and 1.79), having had a genital sore in the last 12 months (AORs = 3.16 and 3.01) and having more than one sexual partner (AORs = 5.95 and 5.15). For husband and wife pairs, suffering sexual violence (AOR = 2.63), husband having other wife/wives (AOR = 3.40) and husband's education being secondary level or higher (AOR = 0.43) were significant. Intervention strategies in India should target young married (aged 25-35 years) and formerly married urban women who are poor, as well as those who have suffered sexual violence from their husbands, and/or are (or whose husbands are) multi-partnered. Empowerment of women is fundamental to HIV/AIDS prevention in India.

Three methods of multi-source feedback compared: a plea for narrative comments and coworkers' perspectives.

BACKGROUND: Doctor performance assessments based on multi-source feedback (MSF) are increasingly central in professional self-regulation. Research has shown that simple MSF is often unproductive. It has been suggested that MSF should be delivered by a facilitator and combined with a portfolio. AIMS: To compare three methods of MSF for consultants in the Netherlands and evaluate the feasibility, topics addressed and perceived impact upon clinical practice. METHOD: In 2007, 38 facilitators and 109 consultants participated in the study. The performance assessment system was composed of (i) one of the three MSF methods, namely, Violato's Physician Achievement Review (PAR), the method developed by Ramsey et al. for the American Board of Internal Medicine (ABIM), or the Dutch Appraisal and Assessment Instrument (AAI), (ii) portfolio, (iii) assessment interview with a facilitator and (iv) personal development plan. The evaluation consisted of a postal survey for facilitators and consultants. Generalized estimating equations were used to assess the association between MSF method used and perceived impact. RESULTS: It takes on average 8 hours to conduct one assessment. The CanMEDS roles 'collaborator', 'communicator' and 'manager' were discussed in, respectively, 79, 74 and 71% of the assessment interviews. The 'health advocate role' was the subject of conversation in 35% of the interviews. Consultants are more satisfied with feedback that contains narrative comments. The perceived impact of MSF that includes coworkers' perspectives significantly exceeds the perceived impact of methods not including this perspective. CONCLUSIONS: Performance assessments based on MSF combined with a portfolio and a facilitator-led interview seem to be feasible in hospital settings. The perceived impact of MSF increases when it contains coworkers' perspectives.

Correlates of health and healthcare performance: applying the Canadian Health Indicators Framework at the provincial-territorial level.

BACKGROUND: Since, at the health system level, there is little research into the possible interrelationships among the various indicators of health, healthcare performance, non-medical determinants of health, and community and health system characteristics, we conducted this study to explore such interrelationships using the Canadian Health Indicators Framework. METHODS: We conducted univariate correlational analyses with health and healthcare performance as outcomes using recent Canadian data and the ten Canadian provinces and three territories as units of the analyses. For health, 6 indicators were included. Sixteen healthcare performance indicators, 12 non-medical determinants of health and 16 indicators of community and health system characteristics were also included as independent variables for the analysis. A set of decision rules was applied to guide the choice of what was considered actual and preferred performance associations. RESULTS: Health (28%) correlates more frequently with non-medical determinants than healthcare does (12%), in the preferred direction. Better health is only correlated with better healthcare performance in 13% of the cases in the preferred direction. Better health (24%) is also more frequently correlated with community and health system characteristics than healthcare is (13%), in the preferred direction. CONCLUSION: Canadian health performance is a function of multiple factors, the most frequent of which may be the non-medical determinants of health and the community characteristics as against healthcare performance. The contribution of healthcare to health may be limited only to relatively small groups which stand to benefit from effective healthcare, but its overall effect may be diluted in summary measures of population health. Interpreting multidimensional, multi-indicator performance data in their proper context may be more complex than hitherto believed.

A performance assessment framework for hospitals: the WHO regional office for Europe PATH project.

OBJECTIVE: The World Health Organization (WHO) Regional Office for Europe launched in 2003 a project aiming to develop and disseminate a flexible and comprehensive tool for the assessment of hospital performance and referred to as the performance assessment tool for quality improvement in hospitals (PATH). This project aims at supporting hospitals in assessing their performance, questioning their own results, and translating them into actions for improvement, by providing hospitals with tools for performance assessment and by enabling collegial support and networking among participating hospitals. METHODS: PATH was developed through a series of four workshops gathering experts representing most valuable experiences on hospital performance assessment worldwide. An extensive review of the literature on hospital performance projects was carried out, more than 100 performance indicators were scrutinized, and a survey was carried out in 20 European countries. RESULTS: Six dimensions were identified for assessing hospital performance: clinical effectiveness, safety, patient centredness, production efficiency, staff orientation and responsive governance. The following outcomes were achieved: (i) definition of the concepts and identification of key dimensions of hospital performance; (ii) design of the architecture of PATH to enhance evidence-based management and quality improvement through performance assessment; (iii) selection of a core and a tailored set of performance indicators with detailed operational definitions; (iv) identification of trade-offs between indicators; (v) elaboration of descriptive sheets for each indicator to support hospitals in interpreting their results; (vi) design of a balanced dashboard; and (vii) strategies for implementation of the PATH framework. CONCLUSION: PATH is currently being pilot implemented in eight countries to refine its framework before further expansion.

How safe is the safety paradigm?

This paper reviews safety initiatives in the health systems of the UK, Canada, Australia, and the US. Initiatives to tackle safety shortcomings involve public-private collaborations. Patient safety agencies (to institute learning, action and safety culture), adverse event reporting and, to a lesser extent, safety related performance indicators are currently used to design safer health systems. Their benefits are mixed, but there is little debate as to their possible side effects. Foreseeable adverse effects of multiple safety organisations stem from them being too many, too vague, too narrowly focused, threatened by the medical practice environment, and too optimistic. Safety related performance indicators are most developed in the US but suffer from inadequacies of administrative data, underreporting, variable indicator definitions, "extended" use, and low sensitivity of the diagnosis coding system, and arguable preventability of the prescribed conditions. A critical appraisal of the implications of these deficiencies is important to assure the safety of current health system safety initiatives and to establish evidence based safety. It is necessary to embed health system safety (as well as patient safety) in the societal culture, structures, and policies which promote effective, user centred, high performance care while allowing for healthy innovation.

Developing a national performance indicator framework for the Dutch health system.

OBJECTIVE: To report on the first phase of the development of a national performance indicator framework for the Dutch health system. METHODS: In January 2002, we initiated an informed interactive process with the intended users-policymakers at the Ministry of Health, Welfare and Sport-and academics to develop both the conceptual framework and its content. Decisions were based on consensus after discussing strategic goals of the health system, information needs of policy makers at the Ministry of Health, Welfare and Sport, and studying existing theory and international experiences with national performance indicator frameworks. We identified objectives and criteria for a framework at the national level, constructed a conceptual model, and selected indicator areas. RESULTS: As a starting point we chose a balanced scorecard reflecting four perspectives towards health system management information at the national level. These perspectives are consumer orientation, finances, delivery of high quality care, and the ability to learn and grow. We then linked the Lalonde model for population health to a balanced scorecard model. The constructed model makes the relationship between population health and health system management apparent, and facilitates the presentation of performance information from various perspectives. The model reflects the strategic goals of the Dutch health system, i.e. contributing to the production of health by providing necessary health care of good quality that is accessible for all Dutch citizens while simultaneously informing policy makers about the performance of the entire health system in all sectors (care, cure, prevention, and social services). The selected indicator areas for health system management information (20 in total) reflect the policy and management functions of the government and the defined public goals of the health system. The model was formally adopted by the Ministry of Health, Welfare and Sport in February 2003, and since then individual indicator areas have been operationalized by 30 representatives of various departments at the Ministry with continuous external research support. CONCLUSION: The merit of linking the balanced scorecard inspired model to public health data is that it facilitates the visualization of the contribution of the health system to the improvement of population health. The method of an intensive interactive indicator development process between policy makers and researchers has so far proven successful.