Ethics issues experienced in HBM within Portuguese health surveillance and research projects

Background: In keeping with the fundamental practice of transparency in the discussion and resolution of ethics conflicts raised by research, a summary of ethics issues raised during Portuguese biomonitoring in health surveillance and research is presented and, where applicable, their resolution is described. Methods: Projects underway aim to promote the surveillance of public health related to the presence of solid waste incinerators or to study associations between human exposure to environmental factors and adverse health effects. The methodological approach involves biomonitoring of heavy metals, dioxins and/or other persistent organic pollutants in tissues including blood, human milk and both scalp and pubic hair in groups such as the general population, children, pregnant women or women attempting pregnancy. As such, the projects entail the recruitment of individuals representing different demographic and health conditions, the collection of body tissues and personal data, and the processing of the data and results. Results: The issue of autonomy is raised during the recruitment of participants and during the collection of samples and data. This right is protected by the requirement for prior written, informed consent from the participant or, in the case of children, from their guardian. Recruitment has been successful, among eligible participants, in spite of incentives rarely being offered. The exception has been in obtaining guardians' consent for children's participation, particularly for blood sampling. In an attempt to mitigate the harm-benefit ratio, current research efforts include alternative less invasive biomarkers. Surveys are currently being conducted under contract as independent biomonitoring actions and as such, must be explicitly disclosed as a potential conflict of interests. Communication of results to participants is in general only practised when a health issue is present and corrective action possible. Concerning human milk a careful approach is taken, considering breast-feeding's proven benefits. Conclusion: No national legislation currently accounts for the surveillance component of biomonitoring as distinct from research. Ethics issues arising within the domain of research are resolved according to available regulations. For issues encountered during surveillance, the same principles are used as guidance, completed by the authors' best judgement and relevant ethics committees' findings.Fundação para a Ciência e a Tecnologia with participation by FEDER, under POCI2010; ref. POCI/ SAU-ESP/58298/2004 (VAEDA) and POCI/SAU-ESP/62115/2004 (FEXHEBIO

Systematic review: Effects, design choices, and context of pay-for-performance in health care

<p>Abstract</p> <p>Background</p> <p>Pay-for-performance (P4P) is one of the primary tools used to support healthcare delivery reform. Substantial heterogeneity exists in the development and implementation of P4P in health care and its effects. This paper summarizes evidence, obtained from studies published between January 1990 and July 2009, concerning P4P effects, as well as evidence on the impact of design choices and contextual mediators on these effects. Effect domains include clinical effectiveness, access and equity, coordination and continuity, patient-centeredness, and cost-effectiveness.</p> <p>Methods</p> <p>The systematic review made use of electronic database searching, reference screening, forward citation tracking and expert consultation. The following databases were searched: Cochrane Library, EconLit, Embase, Medline, PsychINFO, and Web of Science. Studies that evaluate P4P effects in primary care or acute hospital care medicine were included. Papers concerning other target groups or settings, having no empirical evaluation design or not complying with the P4P definition were excluded. According to study design nine validated quality appraisal tools and reporting statements were applied. Data were extracted and summarized into evidence tables independently by two reviewers.</p> <p>Results</p> <p>One hundred twenty-eight evaluation studies provide a large body of evidence -to be interpreted with caution- concerning the effects of P4P on clinical effectiveness and equity of care. However, less evidence on the impact on coordination, continuity, patient-centeredness and cost-effectiveness was found. P4P effects can be judged to be encouraging or disappointing, depending on the primary mission of the P4P program: supporting minimal quality standards and/or boosting quality improvement. Moreover, the effects of P4P interventions varied according to design choices and characteristics of the context in which it was introduced.</p> <p>Future P4P programs should (1) select and define P4P targets on the basis of baseline room for improvement, (2) make use of process and (intermediary) outcome indicators as target measures, (3) involve stakeholders and communicate information about the programs thoroughly and directly, (4) implement a uniform P4P design across payers, (5) focus on both quality improvement and achievement, and (6) distribute incentives to the individual and/or team level.</p> <p>Conclusions</p> <p>P4P programs result in the full spectrum of possible effects for specific targets, from absent or negligible to strongly beneficial. Based on the evidence the review has provided further indications on how effect findings are likely to relate to P4P design choices and context. The provided best practice hypotheses should be tested in future research.</p

Engaging Physicians in Risk Factor Reduction

OptumHealth tested the feasibility of physician-directed population management in 3 primary care practices and with 546 continuously insured patients who exhibited claims markers for coronary artery disease, diabetes, and/or hypertension. During the intervention portion of the study, we asked physicians to improve the following health measurements: blood pressure, body mass index, cholesterol, hemoglobin A1c, and smoking status. We offered a modest pay-for-outcomes incentive for each risk factor improvement achieved. Additionally, on an eligible subset of these patients, we asked physicians to actively refer to population management programs those patients they determined could benefit from nurse or health coach interventions, advising us as to which components of their treatment plan they wished us to address. The 6-month intervention period exhibited a 10-fold improvement in the trend rate of risk factor management success when compared to the prior 6-month period for the same patients. A net of 96 distinct risk factor improvements were achieved by the 546 patients during the intervention period, whereas 9 net risk factor improvements occurred in the comparison period. This difference in improvement trends was statistically significant at P < 0.01. Of the 546 study participants, a subset of 187 members was eligible for participation in OptumHealth care management programs. Physicians identified 80 of these 187 eligible members as appropriate targets for program intervention. Representing ourselves as “calling on behalf” of the physician practices, we established contact with 50 referred members; 43 members (86%) actively enrolled in our programs. This enrollment rate is 2 to 3 times the rate of enrollment through our standard program outreach methods. We conclude that physician-directed population management with aligned incentives offers promise as a method of achieving important health and wellness goals. (Population Health Management 2010;13:255–261

Human exposure to heavy metals in the vicinity of Portuguese solid waste incinerators – Part 3 : Biomonitoring of Pb in blood of children under the age of 6 years

As a part of environmental health surveillance programs related to Portuguese solid waste incinerators (SWI), two biomonitoring projects have been established to investigate additional exposure to lead in children under the age of 6 years living in the vicinity of those facilities. The above-mentioned programs, being the only ones in the country that integrate systematic observations on human exposure to heavy metals, have to provide systematic data from Portuguese regions on the extent and pattern of human exposure to heavy metals, namely to lead. The present paper is the third of a series of papers prepared to accomplish that objective in regards to lead exposure as evaluated by measuring lead levels in children under the age of 6 years. Altogether, 250 children from Lisbon and 247 from Madeira Island have already been involved in the investigation. The present study evaluates spatial and temporal trends of lead exposure, based on comparisons of children’s blood lead levels, either stratified by living area (exposed and control groups), or by time of exposure (T0, the baseline time, and T1, after approximately 2 years of regular operation of the facilities). The results obtained correspond to a relatively reduced number of individuals. Possibly for this reason, they are not fully conclusive in relation to whether living in the vicinity of SWI represents an additional risk of higher exposure to lead. Time trends of lead exposure as evaluated by blood lead levels in children also do not show any clear pattern. These conclusions and the fact that altogether around 3% of children from the whole group have blood lead levels X10 mg/dl warrant further investigation in order to clarify the contribution of incinerator emissions to the levels of lead in children and to identify alternative sources for preventive purposes, taking into consideration the relevance of even low lead exposure from a public health perspective, mainly in relation to children

Human exposure to heavy metals in the vicinity of Portuguese solid waste incinerators—Part 2 : Biomonitoring of lead in maternal and umbilical cord blood

As part of environmental health surveillance programs related to solid waste incinerators located near Lisbon and on Madeira Island, human biomonitoring projects have been implemented in Portugal, some of them focused on crosssectional surveys of heavy metals in blood. One of the general aims of these programs is to provide Portuguese data on the extent and pattern of human exposure to the pollutants potentially released in the stack gases from the incinerators, namely heavy metals. The present investigation reports information specifically on blood lead levels of newborn– mother pairs living in the vicinity of the incinerators under study, as well as of statistically similar participants living outside the exposed area. For Lisbon, lead levels determined at the baseline period (T0), as well as three subsequent evaluations of potential specific impacts of the incinerator (T1, T2 and T3) are described in order to investigate spatial and temporal trends of human exposure to lead. Available data for Madeira, namely lead levels in blood from the study population before the incinerator started operation, is also described. For Lisbon, analyses showed a statistically significant decrease of lead concentrations in maternal and umbilical cord blood during the whole monitoring period. Practically ‘‘overt’’ transplacental exposure to lead was observed only in the Lisbon biomonitoring project and for some cross-sectional surveys. Baseline levels for Madeira were the lowest found in all observations already performed in both programs (maternal and umbilical cord mean lead levels of 0.4 mg/dl and 0.3 mg/dl, respectively). No statistical associations have been found between lead levels in blood and age neither for global populations from Lisbon and Madeira nor for specific groups included in the different observational periods

Foetal exposure to lead and related effects on newborns in two portuguese regions

Subtoxic blood lead levels (BLL) during pregnancy can be responsible for intrauterine delays in foetal development and thus increased risk of morbi-mortality of newborns. Since there is no protective transplacental barrier to lead, foetal exposure is due to maternal environmental exposure together with either increased absorption or bone demineralization with consequent release of lead, or both, that may occur during pregnancy. In non-occupationally exposed women, lead exposure may be increased due to residing near lead sources, consumption of polluted food products, and habits such as alcohol consumption and tobacco smoking. The main purpose of this study was to provide Portuguese data on the extent and pattern of foetal exposure to lead as determined through lead biomonitoring in the blood of pregnant women. Investigation on maternal BLL determinants and potential effects of subtoxic BLL on premature delivery and on newborn's characteristics was also objective of this study