Cytoreductive surgery for ovarian cancer: quality assessment.

Surgery is the cornerstone of treatment of ovarian cancer. Given the importance of achieving no or minimal macroscopic residual disease at primary surgery, performing an assessment of the quality of ovarian cancer surgery is crucial. Assessing the quality of care and surgical outcome allows us to establish baseline information, set standards of care and clear priorities, enable benchmarking against peers, and sustain quality improvement. We know that suboptimal care exists and variation in outcomes results. One way to monitor variation in outcomes is through a clinical quality registry (CQR). A CQR collects a defined minimum dataset to measure performance of an individual or center against a range of clinical quality indicators and provides risk-adjusted, benchmarked data to participating institutions. CQR's are an excellent quality assurance measure as they capture all cases (an opt out system). They permit detection and analysis of unwarranted variations in care. This can provide indications of a systems or process problem, thereby motivating health care providers to improve services and care. Several groups have either developed quality indicators for advanced ovarian cancer surgery (The Scottish Cancer Taskforce and the European Society of Gynecological Oncology) or are in the process of doing so (Australian Society of Gynaecological Oncologists). Indicators should be evidence-based and determined by extensive discussion with experts and stakeholders to ensure appropriateness and buy-in. The Scottish Cancer Taskforce and European Society of Gynecological Oncology have set targets for their quality performance measures, which should provide a quantitative framework for improving care in the surgical management of ovarian cancer.

Multicentre randomized clinical trial to investigate the cost-effectiveness of an allogeneic single-donor fibrin sealant after coronary artery bypass grafting (FIBER Study).

BACKGROUND: Reduction of blood transfusion in cardiac surgery is an important target. The aim of this study was to investigate the cost-effectiveness of the use of CryoSeal®, an allogeneic single-donor fibrin sealant, in patients undergoing coronary artery bypass grafting (CABG). METHODS: This randomized clinical study involved seven cardiac surgery centres in the Netherlands. Patients undergoing elective isolated CABG with the use of at least one internal thoracic artery (ITA) graft were assigned randomly to receive either CryoSeal® (5 ml per ITA bed) or no CryoSeal®. Primary efficacy endpoints were units of transfused red blood cells, fresh frozen plasma and platelet concentrates, and duration of intensive care unit stay. Secondary efficacy endpoints were 48-h blood loss, reoperation for bleeding, mediastinitis, 30-day mortality and duration of hospital stay. RESULTS: Between March 2009 and January 2012, 1445 patients were randomized. The intention-to-treat (ITT) population comprised 1436 patients; the per-protocol (PP) population 1292. In both the ITT and the PP analysis, no significant difference between the treatment groups was observed for any of the primary and secondary efficacy endpoints. In addition, no significant difference between the groups was seen in the proportion of transfused patients. Estimated CryoSeal® costs were €822 (95 per cent c.i. €808 to €836) per patient, which translated to €72,000 per avoided transfusion (unbounded 95 per cent c.i.). CONCLUSION: The use of the fibrin sealant CryoSeal® did not result in health benefits. Combined with the high cost per avoided transfusion, this study does not support the implementation of routine CryoSeal® use in elective isolated CABG. REGISTRATION NUMBER: NTR1386 ( http://www.trialregister.nl).

Factors affecting Medicare Part D beneficiaries' decision to receive comprehensive medication reviews.

OBJECTIVES: To identify factors influencing Medicare Part D beneficiaries' decision to receive pharmacist-provided comprehensive medication reviews (CMRs) and to evaluate their experiences with pharmacist-provided CMRs. DESIGN: Cross-sectional descriptive study. SETTING: Beneficiaries living in Maryland or Minnesota, from November 2011 to January 2012. PARTICIPANTS: Medicare beneficiaries of two Medicare Part D plans who had completed a previous telephone interview for a larger project of medication therapy management quality improvement. INTERVENTION: Self-reported mail survey. MAIN OUTCOME MEASURES: Responses to survey items assessing beneficiaries' perceived importance of proposed factors affecting their decision to receive CMRs and items evaluating patients' experiences with pharmacist-provided CMRs if they had one in the previous year. RESULTS: The valid response rate was 33.4% (238 of 713). Among the proposed factors, "knowing the out-of-pocket cost" (4.12 ± 1.28 [mean ± SD]) and "conducting in the usual pharmacy" (4.01 ± 1.37) were most important in making a decision to get a CMR. Factors rated significantly more important by those who had versus had not received a CMR included "usual pharmacy," "receiving medication list," "physician's support," and "pharmacists discuss changes with physicians." About one-third (30.6%) of respondents reported having pharmacist-provided CMRs within the previous year. Most respondents believed that having CMRs was important for their health (90.6%) and were satisfied with the results of CMRs (94.7%). CONCLUSION: Patients preferred their usual pharmacy or convenient places to have a CMR. Also, a collaborative pharmacist-physician working relationship would be helpful in providing CMRs. Patients who received CMRs expressed a positive attitude toward and satisfaction with pharmacist-provided services.

Variation between hospitals in rates of reported transfusion reactions: is a high reporting rate an indicator of safer transfusion?

BACKGROUND AND OBJECTIVES: It has been suggested that the rate of reported transfusion reactions is positively correlated with safety of the transfusion chain in a hospital. We evaluated this assumption in the Transfusion Reactions in Patients Dutch National Hemovigilance Office database taking reported incorrect blood component transfused as a proxy for unsafe transfusion. METHODS: Reports from 2006 to 2010 and annual numbers of transfused blood components from the 103 hospitals were analysed. The rate of transfusion reactions per 1000 blood components was calculated per hospital. Logistic regression analysis was performed between reporting of at least one incorrect blood component and tertile of transfusion reaction rate. RESULTS: Out of the 103 hospitals, 101 had complete data in some and 93 in all 5years. In all, 72 had reported at least one incorrect blood component transfused; this was associated with blood use level and also with rate of reported transfusion reactions: odds ratio 4·2 (95% confidence interval, 1·3-13·7) in the highest vs. the lowest tertile after adjustment for blood use level. CONCLUSION: Hospitals in the Netherlands which report more transfusion reactions per 1000 units are also more likely to have reported incorrect blood component transfused. The data do not support that hospitals with a higher rate of transfusion reaction reports are safer.

Designing a strategy to implement cost-effective blood transfusion management in elective hip and knee arthroplasties: a study protocol.

BACKGROUND: Total hip and knee arthroplasties are two of the most commonly performed procedures in orthopedic surgery. Different blood-saving measures (BSMs) are used to reduce the often-needed allogenic blood transfusions in these procedures. A recent large randomized controlled trial showed it is not cost effective to use the BSMs of erythropoietin and perioperative autologous blood salvage in elective primary hip and knee arthroplasties. Despite dissemination of these study results, medical professionals keep using these BSMs. To actually change practice, an implementation strategy is needed that is based on a good understanding of target groups and settings and the psychological constructs that predict behavior of medical professionals. However, detailed insight into these issuses is lacking. Therefore, this study aims to explore which groups of professionals should be targeted at which settings, as well as relevant barriers and facilitators that should be taken into account in the strategy to implement evidence-based, cost-effective blood transfusion management and to de-implement BSMs. METHODS: The study consists of three phases. First, a questionnaire survey among all Dutch orthopedic hospital departments and independent treatment centers (n = 99) will be conducted to analyze current blood management practice. Second, semistructured interviews will be held among 10 orthopedic surgeons and 10 anesthesiologists to identify barriers and facilitators that are relevant for the uptake of cost-effective blood transfusion management. Interview questions will be based on the Theoretical Domains Interview framework. The interviews will be followed by a questionnaire survey among 800 medical professionals in orthopedics and anesthesiology (400 professionals per discipline) in which the identified barriers and facilitators will be ranked by frequency and importance. Finally, an implementation strategy will be developed based on the results from the previous phases, using principles of intervention mapping and an expert panel. DISCUSSION: The developed strategy for cost-effective blood transfusion management by de-implementing BSMs is likely to reduce costs for elective hip and knee arthroplasties. In addition, this study will lead to generalized knowledge regarding relevant factors for the de-implementation of non-cost-effective interventions and insight in the differences between implementation and de-implementation strategies.

Development of the Drug Adherence Work-up (DRAW) tool.

OBJECTIVE: To develop and conduct an initial field test of the Drug Adherence Work-up (DRAW) tool, which was developed to guide pharmacists when addressing nonadherence during medication therapy management (MTM) visits. METHODS: The field test was a prospective cohort study, in which seven trained pharmacists used DRAW to evaluate patients by asking about possible reasons for nonadherence during an MTM visit. Pharmacists were notified of potentially nonadherent patients identified through drug claims data analyzed by Outcomes Pharmaceutical Health Care. The pharmacists reported on use of DRAW in an MTM claim and provided opinions about DRAW via an online survey. RESULTS: According to the online survey, pharmacists reported that DRAW helped them to improve the focus of their MTM services and address more adherence problems than their usual approach. They thought the tool was easy to use and well organized. Some commented that DRAW could be a useful tool for teaching pharmacists. The most common reasons reported for nonadherence were the presence of adverse effects (59.1%) or forgetting to take the medication (54.5%). More than three-fourths of patients (77.3%) indicated more than one reason for nonadherence. CONCLUSION: A brief, comprehensive tool to evaluate medication nonadherence, such as DRAW, may help pharmacists address various reasons for medication nonadherence. Often nonadherence is multifaceted, which makes an inclusive tool like DRAW a useful approach; however further research is needed.

Clinical effects of leucoreduction of blood transfusions.

For many years filtration for removal of leucocytes from red blood cell (RBC) and platelet transfusions was applied for selected patients to prevent cytomegalovirus (CMV) (re)activation, HLA immunisation and recurrent febrile nonhaemolytic transfusion reactions (FNHTR ). Since the 1980s, there was also growing concern about cancer recurrence and postoperative infections. In this review we discuss the studies on possible benefits of leucoreduction. In 2001 the Dutch Health Council decided that all blood products should undergo leucoreduction by filtration, as a precautionary measure to reduce possible transmission of variant Creutzfeld-Jacob disease (vCJD). The incidences of transfusion-transmitted CMV infection, HLA immunisation and FN HTR are decreased by universal leucoreduction. However, transfusion-related immunomodulation with presumed negative effects on cancer immunosurveillance, postoperative infections or aggravating organ failure, investigated in randomised controlled trials, revealed no support for extended indications for leucoreduction. An exception was seen in cardiac surgery where leucoreduction reduced short-term mortality by approximately 50%. The exact mechanism(s) for this effect is (are) not known. Pro-inf lammatory cytokines induced by eucocytecontaining RBC transfusions in combination with the inflammatory response after cardiac surgery may aggravate morbidity and could lead to mortality. In this review we discuss the evidence for the benefits of universal leucoreduction. Based on the available evidence, reversal to the use of buffy-coat depleted RBCs and restricted indications for leucoreduction by filtration (extended with open-heart surgery) is a safe option.

The contribution of health technology assessment, health needs assessment, and health impact assessment to the assessment and translation of technologies in the field of public health genomics.

The European Union has named genomics as one of the promising research fields for the development of new health technologies. Major concerns with regard to these fields are, on the one hand, the rather slow and limited translation of new knowledge and, on the other hand, missing insights into the impact on public health and health care practice of those technologies that are actually introduced. This paper aims to give an overview of the major assessment instruments in public health [health technology assessment (HTA), health needs assessment (HNA) and health impact assessment (HIA)] which could contribute to the systematic translation and assessment of genomic health applications by focussing at population level and on public health policy making. It is shown to what extent HTA, HNA and HIA contribute to translational research by using the continuum of translational research (T1-T4) in genomic medicine as an analytic framework. The selected assessment methodologies predominantly cover 2 to 4 phases within the T1-T4 system. HTA delivers the most complete set of methodologies when assessing health applications. HNA can be used to prioritize areas where genomic health applications are needed or to identify infrastructural needs. HIA delivers information on the impact of technologies in a wider scope and promotes informed decision making. HTA, HNA and HIA provide a partly overlapping and partly unique set of methodologies and infrastructure for the translation and assessment of genomic health applications. They are broad in scope and go beyond the continuum of T1-T4 translational research regarding policy translation.

[Public health genomics. The future is built today!]. / Public Health Genomics. Die Zukunft wird heute gestaltet!

The task of public health genomics (PHG) has become a challenge for all healthcare systems having major implications for future research and policy strategies. The various stakeholders in public health play a key role in translating the implications of genomics such as deriving from systems biology, epigenomics, integrative genomics or genome-environmental interactions. Recent advances in systems biology indicate that specific cellular functions are infrequently carried out by single genes, but rather by groups of cellular components. This network-based research is already starting to change nosology as well as to challenge population-based genetic screening or epidemiological methods like HTA. This knowledge will not only enable clinical interventions but also health promotion messages and disease prevention programs to be targeted at susceptible individuals as well as subgroups of the population (personalized healthcare). So far there has been no systematic integration of genome-based knowledge and technologies into public health research, policy, and practice. Thus, the public health agenda demands a vision that reaches beyond the research horizon to arrive at application and health impact of these innovations. The Public Health Genomics European Network (PHGEN) aims to fulfill this task in Europe.

Prediction of pharmacist intention to provide Medicare medication therapy management services using the theory of planned behavior.

BACKGROUND: Medicare Part D is a voluntary prescription drug benefit for Medicare beneficiaries. As part of the coverage, medication therapy management services (MTMS) are mandated for beneficiaries with chronic diseases who take multiple medications covered under part D and who are likely to incur annual costs that exceed a specified level. OBJECTIVE: To predict the behavioral intention of pharmacists to provide Medicare medication therapy management services (MTMS) using the theory of planned behavior (TPB) and to determine the relationship between pharmacists' characteristics and intention to provide MTMS. METHODS: The population for this cross-sectional descriptive study consisted of all community pharmacists in Iowa. Data collection occurred through a self-administered anonymous mail survey. Two surveys each were mailed to 500 pharmacies selected through a stratified random sample, 1 survey for the pharmacy manager and 1 survey for a staff pharmacist if applicable. Descriptive statistics and scale reliability were calculated for each of the 4 TPB scales (attitude, subjective norm, perceived behavioral control, and intention). Linear regression was used to predict intent as a function of the other 3 TPB factors, demographic factors, experience, and type of pharmacy. RESULTS: Out of 212 surveys received, 203 had usable data. The usable response rate ranged from 21% to 41%. Pharmacists' intent to provide MTMS was generally positive but varied in strength with a mean score of 22.47 (+/-4.00) and a range of 7-30. Pharmacists mostly agreed that they had appropriate training to provide MTMS but lacked time and support. The linear regression analysis found the constructs of attitude, subjective norm, and perceived behavioral control to be significant predictors of intent (P<.05). Pharmacists with stronger intent to provide MTMS were those who felt they had more control over providing MTMS, felt their peers approved of the provision of MTMS, and had a positive attitude about providing MTMS. Type of pharmacy and pharmacist demographic variables were not significant predictors of intent to provide MTMS. CONCLUSION: Pharmacists showed generally positive intent to provide MTMS. Perceived behavioral control, subjective norm, and attitude were significant predictors of intent (P<.05). Strategies to help pharmacists provide MTMS should focus on finding time and support to provide MTMS rather than individual educational needs.

Cost-effectiveness of leucocyte-depleted erythrocyte transfusion in cardiac valve surgery.

Cost-effectiveness of leucodepleted erythrocytes (LD) over buffy-coat-depleted packed cells (PC) is estimated from the primary dataset of a recently reported randomized clinical trial involving valve surgery (+/-CABG) patients. Data on the patient level of 474 adult patients who were randomized double-blind to LD or PC were used in order to calculate the healthcare costs and longevity per patient. The incremental cost-effectiveness ratio (ICER) in net costs per life-year gained was established from the healthcare perspective. Bootstrapping and cost-effectiveness acceptability curves were used in order to determine the confidence interval (CI) of the ICER. The longevity of patients in the PC and LD group was 10.6 and 11.4 years, respectively. Relative to PC, LD yielded an estimated 0.8 (95% CI = -0.27 to 1.84) life-year in the baseline. Adjusted for age and sex differences, health gains for LD are 0.4 life-year gained (95% CI = -0.67 to 1.44). Healthcare costs per patient averaged 10163 US dollars per patient in the PC group and 9949 US dollars in the LD group. Average cost-savings were 214 US dollars (95% CI = -1536 to 1964) per patient. Acceptability curves constructed from bootstrap simulations showed a probability of being cost-saving of 59% for universal leucodepletion from the healthcare perspective. The probability of adopting leucodepletion regardless of the costs reaches 92.7%. LD in patients receiving four or more transfusions showed the highest cost-savings and health gains. Leucodepletion of erythrocytes is a cost-saving strategy in cardiac valve (+/-CABG) patients. However, probablistic analysis failed to show a significant difference with buffy-coat-depleted PC.

Evaluation of preventive technologies in Germany: case studies of mammography, prostate cancer screening, and fetal ultrasound.

OBJECTIVE: In this article, three preventive strategies-mammography screening for breast cancer, PSA screening for prostate cancer, and routine ultrasound in normal pregnancy-are discussed in the context of German health care. METHODS: Epidemiologic data and German studies evaluating different aspects of these preventive measures were identified and analyzed. RESULTS: Only a few studies could be identified that investigate these preventive measures. Despite sufficient evidence, in part derived from a German study, there is not yet a mammography screening program. In contrast, ultrasound in pregnancy is offered routinely, although there are controversies regarding the benefit of this practice. PSA screening is not offered as part of the screening program for prostate cancer. However, PSA tests as well as mammographies are done in large numbers in German ambulatory care-a practice that could be considered wild or opportunistic screening. CONCLUSIONS: These case studies show that preventive programs and practices in Germany are not sufficiently based on sound evidence. The paucity of evaluation activities related to prevention in Germany is probably due to the low threshold to introduce new preventive programs into the German healthcare system in the past.

[Leukodepletion of blood products: a requirement for improvement of quality and safety]. / Leukodepletie van bloedproducten: een maatregel ten behoeve van kwaliteit en veiligheid.

The presence of leukocytes in blood products has no beneficial effect on the recipient, except in special situations such as for patients being prepared to receive an organ transplantation. On the other hand the leukocytes have a number of untoward side effects such as HLA immunisation, non haemolytic febrile transfusion reactions, virus transmission and postoperative infections. In response to a request of the Minister of Health, Welfare and Sports, the Health Council of the Netherlands prepared a recommendation on the need of routine leukodepletion by filtration of blood. Although the introduction of leukodepletion of blood products is favoured, it is emphasized that only data from selected patient groups are available while the costs of leukodepletion are considerable. Therefore, an evaluation of the benefits and cost effectiveness of blood filtration is recommended. It is argued that leukodepletion, already introduced in a number of countries, is now considered to be 'state of the art'. Furthermore product liability, public opinion about blood safety and the precaution duty of manufacturers should be taken into account.

[Foundations--a means for implementing strategic goals and measures in public health]. / Stiftungen--ein Instrument zur Umsetzung strategischer Ziele und Massnahmen in Public Health.

Social innovations are happening in many critical areas. Foundations make an enduring contribution towards increasing access to innovations in public welfare based on the philosophy that believes state-run organizations are neither efficient nor responsive to the people's changing needs. In this sense, foundations help to close the gap by turning hitherto tolerated conditions into problems and claims to action. The effectiveness of voluntary bodies as advocates of change owes much to their informal nature. In Germany, voluntary actions in Public Health are still underrepresented. Therefore, donors should be more supported by state government through adequate regulations. In addition, funders need to concentrate their efforts on the limited number of areas where they can have the greatest impact.

Attitudes to water fluoridation in South Africa 1998. Part III. An analysis of pro- and anti-fluoridation attitudes in South Africa.

A survey on attitudes to water fluoridation in the South African population (N = 2,220) was undertaken in 1998. The purpose of this study was to evaluate responses to, and underlying reasons for pro- and anti-fluoridation attitudes. In response to a structured questionnaire, 61.9% of respondents were in favour of fluoride being added to drinking water and 9% were against it. Reasons supporting and opposing this measure were as follows. Of those who favoured the measure, 30% of respondents said it was because it would reduce tooth decay and 30% said it 'affects health', presumably positively. Other reasons include, 'it purifies water' (10.3%), 'more people will be reached' (9.8%), 'it strenghtens bones' (6%), 'it prevents plaque' (4.6%) and it 'improves the taste of water' (3.1%). There was a 1.3% 'don't know' response. Those opposed to the measure said, 'water should stay as it is' (26.1%), 'if it stays in the system it will create other problems' (15.6%), it 'affects health', presumably negatively (12.3%) and 'it will increase the cost of water' (8.8%). The 'don't know' response was 10.5%. When asked to give reasons for their 'don't know' response in the 'uncertain' category, 90% said they did not know. Given the contradictory and variable responses in both 'yes' and 'no' categories, the possible reasons for these findings could include: the differences between knowledge and beliefs, alternative health and lifestyle practices, levels of education, resistance to change and personality factors, among others. Understanding the assumption people make about fluoridation would help to structure education programmes to provide accurate and comprehensive information.

Management practices associated with the incidence rate of clinical mastitis.

Risk factors for the incidence rate of clinical mastitis were studied in 274 Dutch dairy herds. Variables that were associated with resistance to disease were the feeding, housing, and milking machine factors. Variables that were associated with exposure were grazing, combined housing of dry cows and heifers, and calving area hygiene. Postmilking teat disinfection in herds with a low bulk milk somatic cell count and years of practicing dry cow therapy were positively associated with the incidence rate of clinical mastitis. Herds with a low bulk milk somatic cell count and in which postmilking teat disinfection was not used had lower incidence rates of clinical mastitis than did other herds. The incidence rate of clinical mastitis caused by Escherichia coli was mostly related to housing conditions, hygiene, and machine milking. The incidence rate of clinical mastitis caused by Staphylococcus aureus was mostly related to factors associated with bulk milk somatic cell count and factors that might be due to cause and effect reversal. A strong positive correlation existed between the incidence rate of clinical mastitis caused by Streptococcus dysgalactiae and the incidence rate of clinical mastitis caused by Staph. aureus. The incidence rate of clinical mastitis caused by Streptococcus dysgalactiae was related to nutrition, milking technique, and machine milking. The incidence rate of clinical mastitis caused by Streptococcus uberis was associated with factors related to housing, nutrition, and machine milking.