Quasi-experimental evaluation using confirmatory procedures: A case study of an economic and social empowerment intervention to reduce girls' vulnerability to HIV in rural Mozambique.

PURPOSE: Our goal was to determine whether an economic and social empowerment intervention implemented in Zambézia Province, Mozambique reduced girls' vulnerability to HIV. We use this experience to discuss challenges of evaluating real-world interventions. METHODS: Two rounds of data were collected from 885 girls, 13-19 years, for this clustered, non-equivalent (two-stage) cohort trial. We used multi-level exact matching and difference-in-differences estimation to estimate intervention effects on two outcomes: girls' knowledge of gender-based violence and school attendance. RESULTS: Estimates of two outcomes analysed indicated no statistically significant intervention effects. Preliminary analysis of data from the intervention group revealed this study was unable to obtain accurate measures for five outcomes related to HIV vulnerability. CONCLUSIONS: Although our study did not find evidence of impact on the a priori selected outcomes, we report on our experience implementing this robust methodologic design and describe how the challenges encountered in this program setting affected our ability to attain results. We recommend prospective evaluation designs with random allocation be accommodated early during planning. When not possible, quasi-experimental studies should collect data from large samples. To reduce measurement bias, biological endpoints such sexually transmitted infections should serve as primary outcomes for programs intending to reduce sexual behaviors.

International trends in erythropoietin use and hemoglobin levels in hemodialysis patients.

Hemoglobin levels and the dose of erythropoiesis-stimulating agents (ESAs) have risen over time in hemodialysis patients within the United States. There are concerns that these trends may be driven by reimbursement policies that provide potential incentives to increase this use. To determine this we studied trends in the use of ESA and hemoglobin levels in hemodialysis patients and the relationship of these trends to the mode of reimbursement. Using the Dialysis Outcomes and Practice Patterns Study (DOPPS) database of hemodialysis we analyzed facility practices in over 300 randomly selected dialysis units in 12 countries. At each of three phases (years 1996-2001, 2002-2004, and 2005-present), we randomly selected over 7500 prevalent hemodialysis, hemofiltration, or hemodiafiltration patients. ESA usage rose significantly in every country studied except Belgium. All but Sweden demonstrated a substantial increase in hemoglobin levels. In 2005 more than 40% of patients had hemoglobin levels above the KDOQI upper target limit of 120 g/l in all but Japan. These trends appeared to be independent of the manner of reimbursement even though the United States is the only country with significant financial incentives promoting increased use of these agents. Thus, our study found that prescribing higher doses of ESAs and achieving higher hemoglobin levels by physicians reflects a broad trend across DOPPS countries regardless of the reimbursement policies.

[DOPPS estimate of patient life years attributable to modifiable hemodialysis practices in France]. / Gain de vie potentiel pour les patients hémodialysés français attribuable aux modifications des pratiques et la mise en conformité avec les cibles recommandées : une estimation permise par l'étude DOPPS.

In this study, we used a prevalent cross-sectional sample of French hemodialysis patients from Dialysis Outcomes and Practice Patterns Study (DOPPS) 2 (2002-2004) to determine the percentage of patients whose values failed to meet targets in six different areas of hemodialysis practice (dialysis dose, anemia, serum phosphorus (PO(4)), serum calcium (Ca), serum albumin and catheter use for vascular access). Cox survival models, with adjustments for patient characteristics, were used for these analyses to estimate mortality hazard ratios (HR). Based on the mortality HR, the fraction of patients outside each target and the total HD population in France, we estimated the number of patient life years that could potentially be gained if every chronic, in-center hemodialysis patient in France who is currently outside of the specified target was able to achieve it. The proportion of patients failing to meet one of the six practice targets in France varied from 15% (dialysis dose) to 75% (albumin) while the percentage of patients complying with all six targets was restricted to 1.2%. The relative risk of mortality (RR) associated with being outside these targets varied from 1.12 to 1.46. Based on these two measures the life-years survival was estimated. The projected number of patients and life years potentially gained from adherence to the six targets was estimated close to 10,600 years-patient. In conclusion, this study suggests large opportunities to improve hemodialysis patient care in France still exist. Compliance with two major practice targets, such as albumin and restriction of catheter use will save highly significant life years of hemodialysis patient. Implementing and strict adherence to national and international guidelines should serve as a basic inspiration for continual improvement of hemodialysis patient care.

The organization and financing of end-stage renal disease treatment in Japan.

End-stage renal disease (ESRD) affects 230,000 Japanese, with about 36,000 cases diagnosed each year. Recent increases in ESRD incidence are attributed mainly to increases in diabetes and a rapidly aging population. Renal transplantation is rare in Japan. In private dialysis clinics, the majority of treatment costs are paid as fixed fees per session and the rest are fee for service. Payments for hospital-based dialysis are either fee-for-service or diagnosis-related. Dialysis is widely available, but reimbursement rates have recently been reduced. Clinical outcomes of dialysis are better in Japan than in other countries, but this may change given recent ESRD cost containment policies.

Optimizing hemodialysis practices in Canada could improve patient survival.

Data from the Canadian Organ Replacement Registry (CORR) and the Dialysis Outcomes and Practice Patterns Study (DOPPS) were used to determine whether practice patterns have changed in Canada since the introduction of the Canadian Society of Nephrology (CSN) Guidelines in 1999. DOPPS data were then used to calculate the impact of not meeting the proposed guideline targets and to estimate the potential life years gained if all Canadian hemodialysis patients achieved guideline targets. For dialysis dose and hemoglobin targets, Canadian facility performance has significantly improved over time. The vascular access use patterns show trends toward a worse pattern with increased catheter use. A calculation of the percentage of attributable risk suggests that 49% of deaths could possibly be averted if all patients currently outside the guidelines achieved them over the next five years. This corresponds to a decrease in the annual death rate from 18 to 10.1 per hundred patient years. These data support the need for improved adherence to guidelines. If Canadian caregivers were to optimize practice patterns, patient outcomes could be improved.

The financing and organization of medical care for patients with end-stage renal disease in Sweden.

The total health care expenditure as a percentage of the gross domestic product in Sweden is 9.2%, and health care is funded by global budgets almost entirely through general taxation. The prevalence rate of end-stage renal disease (ESRD) in Sweden is 756 per million. Fifty-two percent of ESRD patients have a functioning transplant. Almost all ESRD treatment facilities are public. Compared with other Dialysis Outcomes and Practice Patterns Study (DOPPS) countries, the salaries for both nephrologists and professional dialysis unit staff are low. Sweden's high cost per ESRD patient, relative to other DOPPS countries, may be a result of expensive and frequent hospitalizations and aggressive anemia treatment strategies.

End-stage renal disease and economic incentives: the International Study of Health Care Organization and Financing (ISHCOF).

End-stage renal disease (ESRD) is a debilitating, costly, and increasingly common condition. Little is known about how different financing approaches affect ESRD outcomes and delivery of care. This paper presents results from a comparative review of 12 countries with alternative models of incentives and benefits, collected under the International Study of Health Care Organization and Financing, a substudy within the Dialysis Outcomes and Practice Patterns Study. Variation in spending per ESRD patient is relatively small, but correlated with overall per capita health care spending. Remaining differences in costs and outcomes do not seem strongly linked to differences in incentives.

DOPPS estimate of patient life years attributable to modifiable hemodialysis practices in Canada.

We examined data from the Canadian Organ Replacement Registry, and from a special substudy of CORR, to determine whether changes have occurred in practice patterns before and after the 1999 Canadian Society of Nephrology guidelines were published. Second, we used data from the Dialysis Outcomes and Practice Patterns Study to calculate the impact of observed deviations from guideline targets and estimated potential gains in life years that might accrue if guideline targets were achieved in all Canadian hemodialysis patients. For dialysis dose and hemoglobin targets, there was a significant improvement in Canadian facility performance over time. On the other hand, vascular access care showed a worse pattern with increased catheter use. A calculation of attributable risk, which assumes causality, suggests that 49 percent of deaths could be averted if all patients currently outside the guidelines achieved them over the next five years. When expressed as an annual death rate per hundred patient years, this corresponds to a decrease from 18 to 10.1 deaths per 100 patient years. We conclude that promoting a facility-based culture of quality improvement based on achievement of guideline targets is supported by international and Canadian observational data from the DOPPS. In the future, the impact of such an approach should be assessed empirically by correlating changes in practice over time with changes in outcomes.