Medicare Beneficiaries' Knowledge of and Choices Regarding Part D, 2005 to the Present

In the months before and years since Medicare Part D's implementation in January 2006, many have been concerned with beneficiaries' ability to benefit from the complex program. A systematic review of published Medline and gray literature from January 1, 2005, to August 20, 2009, was undertaken to evaluate Medicare beneficiaries' knowledge about Part D and how this knowledge informed decisions regarding enrollment and plan choice. Thirty articles that reported original results describing seniors' knowledge of the Part D benefit, decision to enroll, or selection of plans; results from patient surveys addressing these issues; or results that analyzed enrollment data or plan selection patterns were included. Of these 30 articles, 10 described beneficiaries' knowledge, 12 described enrollment and plan choices, and eight described knowledge and choice. Across studies and years, beneficiaries' knowledge of the Part D program and benefit structure and design was poor, particularly with regard to the coverage gap and the low‐income subsidy. Beneficiaries had great difficulty choosing the lowest‐cost Part D plans and were disinclined to switch plans to improve their benefits. Knowledge deficits, enrollment problems, and plan choice difficulties were most pronounced during Part D implementation in early 2006 but persisted in subsequent years of the benefit. Beneficiaries' knowledge and choices should be monitored on an ongoing basis to inform potential changes to the Part D program.     

Changes in Drug Use and Out‐of‐Pocket Costs Associated with Medicare Part D Implementation: A Systematic Review

Medicare Part D was implemented 4 years ago. Despite the fact that public‐use Part D data were unavailable until late 2008, researchers have used alternate data to examine the effect of Part D on drug use and out‐of‐pocket costs. In a systematic review of Medline from 2006 to October 2009, the literature about drug use and costs after implementation and during the transition period and coverage gap was summarized. Studies presenting original results regarding drug use and costs after Part D implementation were included. Case reports and series and simulation studies were excluded. Of 552 originally identified articles, 26 met selection criteria: 13 regarding the overall effect of Part D in the year(s) after implementation, seven describing the Part D transition period, and six concerning the coverage gap. Part D implementation was associated with a 6% to 13% increase in drug use and a 13% to 18% decrease in patient costs. The transition period was associated with no significant changes in use or costs for elderly dual‐eligible beneficiaries, but effects in other populations were mixed. Entry into the coverage gap was associated with a 9% to 16% decrease in drug use and increases in costs of up to 89%. In summary, studies examining disparate data regarding the implementation of Part D found consistent positive effects on drug use and costs but revealed unfavorable trends in the coverage gap. The effect of the Part D transition period remains unclear. Although public‐use data will validate these results, policymakers can use the existing evidence to inform changes and enhancements to Part D immediately.     

The Effect of Transitioning to Medicare Part D Drug Coverage in Seniors Dually Eligible for Medicare and Medicaid

OBJECTIVES: To evaluate medication use, out‐of‐pocket spending, and medication switching during the transition period for patients dually eligible for Medicaid and Medicare (dual eligibles). DESIGN: Time‐trend analysis, using segmented linear regression. SETTING: Patient‐level pharmacy dispensing data from January 2005 to December 2006 from a large pharmacy chain with stores in 34 states. PARTICIPANTS: Dual eligibles aged 65 and older. MEASUREMENTS: Changes in utilization, patient copayments, and medication switching were analyzed using interrupted time trend analyses. Utilization and spending were evaluated for five study drugs: clopidogrel, proton pump inhibitors (PPIs), warfarin, and statins (essential drugs covered by Part D plans) and benzodiazepines (not covered through Part D but potentially covered through Medicaid). RESULTS: Drug use for 13,032 dual eligibles was evaluated. There was no significant effect of the transition to Medicare Part D on use of all study drugs, including the uncovered benzodiazepines. Cumulative reductions were seen in copayments for all covered drugs after implementation of Part D, ranging from 25% annually for PPIs to 53% for warfarin, but there was a larger increase in copayments, 91% annually, for benzodiazepines after the transition. The rate of switching medications was 3.0 times as great for the PPIs after implementation of Part D than before implementation, but there was no significant change in the other study drug classes. CONCLUSION: These findings in a single, large pharmacy chain indicate that the transition plan for dual eligibles led to less medication discontinuation and switching than many had expected. The substantially greater cost sharing for benzodiazepines highlights the importance of implementing a thoughtful transition plan when executing such a national policy.     

The effect of Plasmodium falciparum on cognition: a systematic review

OBJECTIVE: Systematic review to investigate the relationship between Plasmodium falciparum infection and cognitive function. METHOD: We searched MEDLINE, EMBASE and PsycINFO, and hand-searched journals and PhD theses. The inclusion criteria were (1) use of standardized tests for the specific populations and/or appropriate controls; (2) clear differentiation between children and adults. Eighteen studies were eligible, of which three gave information on all cognitive domains considered in the review. RESULTS: Deficits in attention, memory, visuo-spatial skills, language and executive functions may occur after malaria infection. These deficits are not only caused by cerebral falciparum malaria, but also appear to occur in less severe infections. P. falciparum seems to affect the brain globally, not in a localised fashion. Outcome depends on both biological and social risk factors. CONCLUSION: Future research should seek to establish the extent of these cognitive deficits using culturally appropriate techniques and well-defined criteria of disease.     

Genetic variants and the metabolic syndrome: a systematic review

Several candidate gene studies on the metabolic syndrome (MetS) have been conducted. However, for most single nucleotide polymorphisms (SNPs) no systematic review on their association with MetS exists. A systematic electronic literature search was conducted until the 2nd of June 2010, using HuGE Navigator. English language articles were selected. Only genes of which at least one SNP–MetS association was studied in an accumulative total population ≥4000 subjects were included. Meta‐analyses were conducted on SNPs with three or more studies available in a generally healthy population. In total 88 studies on 25 genes were reviewed. Additionally, for nine SNPs in seven genes (GNB3, PPARG, TCF7L2, APOA5, APOC3, APOE, CETP) a meta‐analysis was conducted. The minor allele of rs9939609 (FTO), rs7903146 (TCF7L2), C56G (APOA5), T1131C (APOA5), C482T (APOC3), C455T (APOC3) and 174G>C (IL6) were more prevalent in subjects with MetS, whereas the minor allele of Taq‐1B (CETP) was less prevalent in subjects with the MetS. After having systematically reviewed the most studied SNP–MetS associations, we found evidence for an association with the MetS for eight SNPs, mostly located in genes involved in lipid metabolism.     

Thrombophilia in pregnancy: a systematic review

Growing evidence suggests that thrombophilia is associated with venous thromboembolism (VTE) and adverse pregnancy outcomes. However, methodological limitations have made it difficult to obtain a clear overview of the overall risks. We conducted a systematic review to determine the risk of VTE and adverse pregnancy outcomes associated with thrombophilia in pregnancy. The effectiveness of prophylactic interventions during pregnancy was also evaluated. Major electronic databases were searched, relevant data abstracted and study quality assessed by two independent reviewers. Odds ratios (ORs) stratified by thrombophilia type were calculated for each outcome. A total of 79 studies were included in our review. The risks for individual thrombophilic defects were determined for VTE (ORs, 0.74-34.40); early pregnancy loss (ORs, 1.40-6.25); late pregnancy loss (ORs, 1.31-20.09); pre-eclampsia (ORs, 1.37-3.49); placental abruption (ORs, 1.42-7.71) and intrauterine growth restriction (ORs, 1.24-2.92). Low-dose aspirin plus heparin was the most effective in preventing pregnancy loss in thrombophilic women (OR, 1.62). Our findings confirm that women with thrombophilia are at risk of developing VTE and complications in pregnancy. However, despite the increase in relative risk, the absolute risk of VTE and adverse outcomes remains low. There is also a lack of controlled trials of antithrombotic intervention to prevent pregnancy complications. Thus, at present, universal screening for thrombophilia in pregnancy cannot be justified clinically.     

Trichomoniasis treatment in women: a systematic review

objective  To compare the effectiveness of various treatment strategies for trichomoniasis in women.
data sources  Medline from 1966 to1996, Embase from 1986 to 1996, Science Citation Index from 1990 to 1996; reference lists of existing reviews; through the manufacturers of metronidazole and tinidazole in the UK, the Cochrane Controlled Trials Register until October 1997 and informal discovery.
study selection  Any randomized or quasi-randomized trial in nonpregnant women with trichomoniasis where different treatment strategies were compared. 45 of the 124 identified studies met the criteria and were included in the review.
data extraction  Settings, diagnostic methods, exclusions, loss to follow-up and partner treatment strategies were extracted. Outcomes sought were parasitological cure, clinical cure and side-effects of treatment.
results  Most trials were small, with only two trials containing more than 100 women in each comparison group. Only 11 trials followed up women for more than one month. Oral nitroimidazoles were effective in achieving parasitological cure. Fourteen trials compared different treatment strategies with the remainder comparing different doses or different drugs. Partner treatment was effective in decreasing longer-term re-infection rates in the one trial testing this.
conclusions  Parasitological cure can be achieved by a single oral dose of nitroimidazoles. There is, however, very little data on partner treatment strategies and long-term cure rates after initial treatment. Further research should test various partner treatment strategies to prevent re-infections and reduce trichomoniasis prevalence.     

Exenatide efficacy and safety: a systematic review

Objective To examine the efficacy, effectiveness and side effects of exenatide when compared with oral glucose‐lowering agents or insulin therapy. Research design and methods Relevant citations were identified from searches of multiple bibliographic databases supplemented with searches of the US Food and Drug Administration website and other sources. A qualitative synthesis was performed, with a random effects meta‐analysis when appropriate. Results We identified 17 studies. In placebo‐controlled trials of subjects with poorly controlled diabetes (with both groups receiving various oral glucose‐lowering agents), exenatide 10 μg twice daily improved glycated haemoglobin (HbA_1c) by approximately 1.0% over 30 weeks [pooled estimate ?0.97%, 95% confidence interval (CI), ?1.16 to ?0.79%, P < 0.0001] and exenatide treatment over 16–30 weeks was associated with weight loss of 1.0–2.5 kg. Exenatide appeared to confer a similar benefit to various insulin regimes for glycaemic control at follow‐up between 16 and 52 weeks (pooled estimate HbA_1c?0.04%, 95% CI, ?0.14 to 0.06%, P = 0.41), but was advantageous over insulin with respect to weight loss (3–6 kg loss at up to 52 weeks of follow‐up). Nausea was the most common adverse event in placebo‐ and active‐controlled trials. Rates of hypoglycaemia were similar in exenatide and insulin groups, but were higher with exenatide 10 μg twice daily compared with placebo and hypoglycaemia was most frequent when a sulphonylurea was administered. Conclusions In subjects with poorly controlled diabetes, exenatide was associated with a reduction in HbA_1c that was similar to introducing another oral agent or insulin. Weight loss may be an advantage with exenatide. Long‐term studies in diverse and unselected populations are needed to clarify the benefit vs. harm profile of this drug.