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Research in Social & Administrative... Jan 2023The rising cost of medications has a disproportionate effect on community-dwelling older adults despite policy changes designed to improve medication access. Medicare... (Review)
Review
BACKGROUND
The rising cost of medications has a disproportionate effect on community-dwelling older adults despite policy changes designed to improve medication access. Medicare insurance counseling provided by pharmacists, including individualized plan comparison and enrollment assistance, improves medication adherence and health care utilization, yet only 15% of community dwelling older adults report using a pharmacy or pharmacist for Medicare information. To determine what information is available to inform expanding implementation of pharmacy as a resource for Medicare insurance counseling, a systematic review of published studies using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework was conducted.
METHODS
Articles meeting inclusion criteria were identified through a literature search using PubMed and GoogleScholar; 27 pharmacy Medicare insurance counseling studies were identified representing 13 unique programs in clinical, community outreach, and community pharmacy settings. Each article was coded by two researchers using the RE-AIM Coding Sheet for Publications and the extent of RE-AIM dimension reporting was determined using descriptive statistics at the program level. Discussions were used to arrive at coding consensus and concordance was measured with Krippendorff's alpha.
RESULTS
Across all studies (15 quasi experimental, 10 analytical case reports, and 2 case reports) more than half of the programs reported framework component dimensions for Reach (69%), Adoption (58%), Implementation (54%), and Maintenance (54%), and fewer than half reported comprehensively on Effectiveness (44%). Ten studies in 7 of 13 programs reported estimated out-of-pocket cost savings. Two studies measured patient-centered outcomes: medication adherence by proportion of days covered (PDC) and health care utilization by hospital admissions and emergency department visits. Gaps in the external validity of pharmacy Medicare education programs were identified including staff participation rates, methods to identify participating settings and program costs.
CONCLUSIONS
Based on this review, current research on pharmacy Medicare education is insufficient to guide broad implementation. Additional studies are needed to determine how Medicare education integrating pharmacists and pharmacies can be implemented to address cost-related non-adherence for community dwelling older adults.
Topics: Aged; United States; Humans; Medication Therapy Management; Medicare; Pharmacists; Medication Adherence; Health Services Accessibility
PubMed: 36085121
DOI: 10.1016/j.sapharm.2022.08.013 -
The American Journal of Managed Care Aug 2022CMS' coverage with evidence development (CED) policy allows Medicare beneficiaries to access promising therapies and services while additional data are collected. CED...
OBJECTIVES
CMS' coverage with evidence development (CED) policy allows Medicare beneficiaries to access promising therapies and services while additional data are collected. CED program characteristics are mostly unreported, and qualities associated with retirement of CED data collection requirements are unknown. We aimed to review and systematically describe CED program history and components and report programmatic elements correlated with retirement of CED data collection requirements, while identifying areas for policy improvement.
STUDY DESIGN
Systematic review.
METHODS
We extracted CED information from the CMS website, ClinicalTrials.gov, PubMed, internet searches, and communication with CMS.
RESULTS
There were 27 CED determinations from 2005 to 2022 in 8 therapeutic areas, with the most for cardiovascular diseases (8/27; 30%). Duration of CED programs (range, 1-16 years) and the number of related registries and clinical trials (range, 0-34) were widely variable. Only 4 CEDs have had data collection requirements with continued National Coverage Determination (NCD); 3 relate to cardiovascular therapies, and all have some public availability of findings resulting from CED-related data collection mechanisms. There were 2 instances of NCD revocation and deferral to local coverage decisions.
CONCLUSIONS
Changes in the CED program through improving program predictability and transparency with regard to outstanding questions, roles of relevant stakeholders, and requirements for reporting and reevaluation would strengthen the program's effectiveness. Ultimately, these improvements would provide incentives for stakeholder participation in data collection to achieve the goal of increasing access to beneficial therapies and improving clinical outcomes.
Topics: Aged; Humans; Medicare; Noncommunicable Diseases; Program Development; Registries; United States
PubMed: 35981123
DOI: 10.37765/ajmc.2022.88870 -
Advances in Therapy Oct 2016Rituximab plus fludarabine and cyclophosphamide (RFC) is the standard of care for fit patients with untreated chronic lymphocytic leukemia (CLL); however, its use is... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Rituximab plus fludarabine and cyclophosphamide (RFC) is the standard of care for fit patients with untreated chronic lymphocytic leukemia (CLL); however, its use is limited in 'unfit' (co-morbid and/or full-dose F-ineligible) patients due to its toxicity profile. We conducted a systematic review and Bayesian network meta-analysis (NMA) to determine the relative efficacy of commercially available interventions for the first-line treatment of unfit CLL patients.
METHODS
For inclusion in the NMA, studies had to be linked via common treatment comparators, report progression-free survival (PFS), and/or overall survival (OS), and meet at least one of the five inclusion criteria: median cumulative illness score >6, median creatinine clearance ≤70 mL/min, existing co-morbidities, median age ≥70 years, and no full-dose F in the comparator arm. A manual review, validated by external experts, of all studies that met at least one of these criteria was also performed to confirm that they evaluated first-line therapeutic options for unfit patients with CLL.
RESULTS
In unfit patients, the main NMA (five studies for PFS and four for OS) demonstrated clear preference in terms of PFS for obinutuzumab + chlorambucil (G-Clb) versus rituximab + chlorambucil (R-Clb), ofatumumab + chlorambucil (O-Clb), fludarabine and chlorambucil (median hazard ratios [HRs] 0.43, 0.33, 0.20, and 0.19, respectively), and a trend for better efficacy versus rituximab + bendamustine (R-Benda) and RFC-Lite (median HR 0.81 and 0.88, respectively). OS results were generally consistent with PFS data, (median HR 0.48, 0.53, and 0.81, respectively) for G-Clb versus Clb, O-Clb, and R-Clb 0.35 and 0.81 versus F and R-Benda, respectively); however, the OS findings were associated with higher uncertainty. Treatment ranking reflected improved PFS and OS with G-Clb over other treatment strategies (median rank of one for both endpoints).
CONCLUSION
G-Clb is likely to show superior efficacy to other treatment options selected in our NMA for unfit treatment-naïve patients with CLL.
FUNDING
F. Hoffmann-La Roche Ltd.
Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Comorbidity; Contraindications; Drug-Related Side Effects and Adverse Reactions; Humans; Leukemia, Lymphocytic, Chronic, B-Cell; Medication Therapy Management; Patient Selection; Treatment Outcome
PubMed: 27535291
DOI: 10.1007/s12325-016-0398-2 -
Ophthalmology May 2014To describe what information is or is not included in health care claims data, provide an overview of the main advantages and limitations of performing analyses using... (Review)
Review
OBJECTIVE
To describe what information is or is not included in health care claims data, provide an overview of the main advantages and limitations of performing analyses using health care claims data, and offer general guidance on how to report and interpret findings of ophthalmology-related claims data analyses.
DESIGN
Systematic review.
PARTICIPANTS
Not applicable.
METHODS
A literature review and synthesis of methods for claims-based data analyses.
MAIN OUTCOME MEASURES
Not applicable.
RESULTS
Some advantages of using claims data for analyses include large, diverse sample sizes, longitudinal follow-up, lack of selection bias, and potential for complex, multivariable modeling. The disadvantages include (a) the inherent limitations of claims data, such as incomplete, inaccurate, or missing data, or the lack of specific billing codes for some conditions; and (b) the inability, in some circumstances, to adequately evaluate the appropriateness of care. In general, reports of claims data analyses should include clear descriptions of the following methodological elements: the data source, the inclusion and exclusion criteria, the specific billing codes used, and the potential confounding factors incorporated in the multivariable models.
CONCLUSIONS
The use of claims data for research is expected to increase with the enhanced availability of data from Medicare and other sources. The use of claims data to evaluate resource use and efficiency and to determine the basis for supplementary payment methods for physicians is anticipated. Thus, it will be increasingly important for eye care providers to use accurate and descriptive codes for billing. Adherence to general guidance on the reporting of claims data analyses, as outlined in this article, is important to enhance the credibility and applicability of findings. Guidance on optimal ways to conduct and report ophthalmology-related investigations using claims data will likely continue to evolve as health services researchers refine the metrics to analyze large administrative data sets.
Topics: Data Collection; Delivery of Health Care; Eye Diseases; Health Resources; Health Services Research; Humans; Insurance Claim Review; Medicare; Ophthalmology; United States
PubMed: 24433971
DOI: 10.1016/j.ophtha.2013.11.038 -
Health Services Research Oct 2020To review the evidence of the association between performance in eight indicators of diabetes care and a patient's race/ethnicity and socioeconomic characteristics. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To review the evidence of the association between performance in eight indicators of diabetes care and a patient's race/ethnicity and socioeconomic characteristics.
DATA SOURCE
Studies of adult patients with type 2 diabetes in MEDLINE published between January 1, 2000, and December 31, 2018.
STUDY DESIGN
Systematic review and meta-analysis of regression-based studies including race/ethnicity and income or education as explanatory variables. Meta-analysis was used to quantify differences in performance associated with patient race/ethnicity or socioeconomic characteristics. The systematic review was used to identify potential mechanisms of disparities.
DATA COLLECTION
Two coauthors separately conducted abstract screening, study exclusions, data extraction, and scoring of retained studies. Estimates in retained studies were extracted and, where applicable, were standardized and converted to odds ratios and standard errors.
PRINCIPAL FINDINGS
Performance in intermediate outcomes and process measures frequently exhibited differences by race/ethnicity even after adjustment for socioeconomic, lifestyle, and health factors. Meta-analyses showed black patients had lower odds of HbA1c and blood pressure (BP) control (OR range: 0.67-0.68, P < .05) but higher odds of receiving eye or foot examination (OR range: 1.22-1.47, P < .05) relative to white patients. A high school degree or more was associated with higher odds of HbA1c control and receipt of eye examinations compared to patients without a degree. Meta-analyses of income included a handful of studies and were inconsistently associated with diabetes care performance. Differences in diabetes performance appear to be related to access-related factors such as uninsurance or lacking a usual source of care; food insecurity and trade-offs at very low incomes; and lower adherence among younger and healthier diabetes patients.
CONCLUSIONS
Patient race/ethnicity and education were associated with differences in diabetes quality measures. Depending on the approach used to rate providers, not adjusting for these patient characteristics may penalize or reward providers based on the populations they serve.
Topics: Age Factors; Blood Pressure; Diabetes Mellitus, Type 2; Ethnicity; Glycated Hemoglobin; Health Behavior; Health Services Accessibility; Health Status; Humans; Life Style; Quality Indicators, Health Care; Quality of Health Care; Racial Groups; Sex Factors; Socioeconomic Factors
PubMed: 32720345
DOI: 10.1111/1475-6773.13326 -
Osteoporosis International : a Journal... Jan 2020Patients with chronic kidney disease (CKD) are more likely to experience falls and fractures due to renal osteodystrophy and the high prevalence of risk factors for... (Meta-Analysis)
Meta-Analysis
Patients with chronic kidney disease (CKD) are more likely to experience falls and fractures due to renal osteodystrophy and the high prevalence of risk factors for falls. However, it is not well established how great the risk is for falls and fractures for the different stages of CKD compared to the general population. The objective of this systematic review and meta-analysis was to assess whether, and in which degree, CKD was associated with falls and fractures in adults. A systematic search in PubMed, Embase, CINAHL, and The Cochrane Library was performed on 7 September 2018. All retrospective, cross-sectional, and longitudinal studies of adults (18 years of older) that studied the association between CKD, fractures, and falls were included. Additional studies were identified by cross-referencing. A total of 39 publications were included, of which two publications assessed three types of outcome and four publications assessed two types of outcome. Ten studies focused on accidental falling; seventeen studies focused on hip, femur, and pelvis fractures; seven studies focused on vertebral fractures; and thirteen studies focused on any type of fracture without further specification. Generally, the risk of fractures increased when kidney function worsened, with the highest risks in the patients with stage 5 CKD or dialysis. This effect was most pronounced for hip fractures and any type of fractures. Furthermore, results on the association between CKD and accidental falling were contradictory. Compared to the general population, fractures are highly prevalent in patients with CKD. Besides more awareness of timely fracture risk assessment, there also should be more focus on fall prevention.
Topics: Accidental Falls; Adult; Aged; Case-Control Studies; Cohort Studies; Cross-Sectional Studies; Female; Fractures, Bone; Humans; Male; Medicare; Nutrition Surveys; Prospective Studies; Renal Insufficiency, Chronic; Retrospective Studies; United States
PubMed: 31720721
DOI: 10.1007/s00198-019-05190-5 -
Annals of Internal Medicine Mar 2009The Centers for Medicare & Medicaid Services limit coverage of cancer drugs for off-label indications to indications listed in specified compendia. (Comparative Study)
Comparative Study Review
BACKGROUND
The Centers for Medicare & Medicaid Services limit coverage of cancer drugs for off-label indications to indications listed in specified compendia.
PURPOSE
To assess whether compendia provide comprehensive, research-based, and timely information for off-label prescribing in oncology.
DATA SOURCES
6 drug compendia, English-language literature searches of MEDLINE and the Cochrane Central Register of Controlled Trials from 2006 and 2008, and American Society of Clinical Oncology annual meeting abstracts from 2004 to 2007. Data Assessment: The compendia's stated methods, literature related to off-label indications of 14 cancer drugs in 2006, updated literature related to 1 off-label indication between 2006 and 2008, and completeness of compendia content and citations were assessed.
DATA SYNTHESIS
The compendia's stated methods varied greatly from their actual practices. Compendia cited little of the available evidence, often neither the most recent nor that of highest methodological quality. Compendia differed in evidence cited, terminology, detail, presentation, and referencing. For the 14 off-label indications studied, the compendia differed in the indications included and whether and how they recommended particular agents for particular types of cancer. Update schedules varied, and documentation practices made it difficult to determine whether and when compendia content was updated. For 1 indication, compendia citations did not increase between 2006 and 2008 despite newly published articles.
LIMITATIONS
The 2006 analysis was limited to 14 off-label indications; the 2008 update examined 1 indication. Only off-label indications for cancer drugs were included, and results cannot be generalized to noncancer drugs or indications.
CONCLUSION
Oncologists rely on compendia for up-to-date access to evidence and reimbursement information for off-label indications. Current compendia lack transparency, cite little current evidence, and lack systematic methods to review or update evidence.
Topics: Antineoplastic Agents; Drug Approval; Drug Labeling; Evidence-Based Medicine; Medicaid; Medicare; Pharmacopoeias as Topic; Prescription Drugs; Reference Books, Medical; United States
PubMed: 19221366
DOI: 10.7326/0003-4819-150-5-200903030-00107 -
Hypertension (Dallas, Tex. : 1979) Jul 2017There is a critical need for blood pressure-lowering strategies that have greater efficacy and minimal side effects. Low-dose combinations hold promise in this regard,... (Meta-Analysis)
Meta-Analysis Review
There is a critical need for blood pressure-lowering strategies that have greater efficacy and minimal side effects. Low-dose combinations hold promise in this regard, but there are few data on very-low-dose therapy. We, therefore, conducted a systematic review and meta-analysis of randomized controlled trials with at least one quarter-dose and one placebo and standard-dose monotherapy arm. A search was conducted of Medline, Embase, Cochrane Registry, Food and Drug Administration, and European Medicinal Agency websites. Data on blood pressure and adverse events were pooled using a fixed-effect model, and bias was assessed using Cochrane risk of bias. The review included 42 trials involving 20 284 participants. Thirty-six comparisons evaluated quarter-dose with placebo and indicated a blood pressure reduction of -4.7/-2.4 mm Hg (<0.001). Six comparisons were of dual quarter-dose therapy versus placebo, observing a -6.7/ -4.4 mm Hg (<0.001) blood pressure reduction. There were no trials of triple quarter-dose combination versus placebo, but one quadruple quarter-dose study observed a blood pressure reduction of -22.4/-13.1 mm Hg versus placebo (<0.001). Compared with standard-dose monotherapy, the blood pressure differences achieved by single (37 comparisons), dual (7 comparisons), and quadruple (1 trial) quarter-dose combinations were +3.7/+2.6 (<0.001), +1.3/-0.3 (NS), and -13.1/-7.9 (<0.001) mm Hg, respectively. In terms of adverse events, single and dual quarter-dose therapy was not significantly different from placebo and had significantly fewer adverse events compared with standard-dose monotherapy. Quarter-dose combinations could provide improvements in efficacy and tolerability of blood pressure-lowering therapy.
Topics: Antihypertensive Agents; Blood Pressure; Dose-Response Relationship, Drug; Drug Therapy, Combination; Humans; Hypertension; Medication Therapy Management; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 28584013
DOI: 10.1161/HYPERTENSIONAHA.117.09202 -
BMC Family Practice Jan 2017Medication review is often recommended to optimize medication use. In clinical practice it is mostly operationalized as an intervention without co-interventions during a... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Medication review is often recommended to optimize medication use. In clinical practice it is mostly operationalized as an intervention without co-interventions during a short term intervention period. However, most systematic reviews also included co-interventions and prolonged medication optimization interventions. Furthermore, most systematic reviews focused on specific patient groups (e.g. polypharmacy, elderly, hospitalized) and/or on specific outcome measures (e.g. hospital admissions and mortality). Therefore, the objective of this study is to assess the effectiveness of medication review as an isolated short-term intervention, irrespective of the patient population and the outcome measures used.
METHODS
A literature search was performed in MEDLINE, EMBASE and Web of Science from their inception through September 2015. Randomized controlled trials (RCTs) with medication review as isolated short term intervention (<3 months) were included. There were no restrictions with regard to patient characteristics and outcome measures. One reviewer extracted and a second checked data. The risk of bias of studies was evaluated independently by two reviewers. A best evidence synthesis was conducted for every outcome measure used in more than one trial. In case of binary variables a meta-analysis was performed in addition to the best evidence synthesis, to quantify the effect.
RESULTS
Thirty-one RCTs were included in this systematic review (55% low risk of bias). A best evidence synthesis was conducted for 22 outcome measures. No effect of medication review was found on clinical outcomes (mortality, hospital admissions/healthcare use, the number of patients falling, physical and cognitive functioning), except a decrease in the number of falls per patient. However, in a sensitivity analysis using a more stringent threshold for risk of bias, the conclusion for the effect on the number of falls changed to inconclusive. Furthermore no effect was found on quality of life and evidence was inconclusive about the effect on economical outcome measures. However, an effect was found on most drug-related problems: medication review resulted in a decrease in the number of drug-related problems, more changes in medication, more drugs with dosage decrease and a greater decrease or smaller increase of the number of drugs.
CONCLUSIONS
An isolated medication review during a short term intervention period has an effect on most drug-related outcomes, minimal effect on clinical outcomes and no effect on quality of life. No conclusion can be drawn about the effect on economical outcome measures. Therefore, it should be considered to stop performing cross-sectional medication reviews as standard care.
Topics: Drug Costs; Drug Utilization; Evidence-Based Medicine; Female; Health Care Costs; Humans; Male; Medication Therapy Management; Pharmaceutical Preparations; Pharmaceutical Services; Randomized Controlled Trials as Topic; Treatment Outcome; United States
PubMed: 28095780
DOI: 10.1186/s12875-016-0577-x -
JAMA Cardiology Jun 2016The Million Hearts initiative emphasizes ABCS (aspirin for high-risk patients, blood pressure [BP] control, cholesterol level management, and smoking cessation).... (Review)
Review
IMPORTANCE
The Million Hearts initiative emphasizes ABCS (aspirin for high-risk patients, blood pressure [BP] control, cholesterol level management, and smoking cessation). Evidence of the effects of drugs used to achieve ABCS has not been synthesized comprehensively in the prevention of primary atherosclerotic cardiovascular disease (ASCVD).
OBJECTIVE
To compare the efficacy and safety of aspirin, BP-lowering therapy, statins, and tobacco cessation drugs for fatal and nonfatal ASCVD outcomes in primary ASCVD prevention.
EVIDENCE REVIEW
Structured search of the Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment Database (HTA), MEDLINE, EMBASE, and PROSPERO International Prospective Systematic Review Trial Register to identify systematic reviews published from January 1, 2005, to June 17, 2015, that reported the effect of aspirin, BP-lowering therapy, statin, or tobacco cessation drugs on ASCVD events in individuals without prevalent ASCVD. Additional studies were identified by searching the reference lists of included systematic reviews, meta-analyses, and health technology assessment reports. Reviews were selected according to predefined criteria and appraised for methodologic quality using the Assessment of Multiple Systematic Reviews (AMSTAR) tool (range, 0-11). Studies were independently reviewed for key participant and intervention characteristics. Outcomes that were meta-analyzed in each included review were extracted. Qualitative synthesis was performed, and data were analyzed from July 2 to August 13, 2015.
FINDINGS
From a total of 1967 reports, 35 systematic reviews of randomized clinical trials were identified, including 15 reviews of aspirin, 4 reviews of BP-lowering therapy, 12 reviews of statins, and 4 reviews of tobacco cessation drugs. Methodologic quality varied, but 30 reviews had AMSTAR ratings of 5 or higher. Compared with placebo, aspirin (relative risk [RR], 0.90; 95% CI, 0.85-0.96) and statins (RR, 0.75; 95% CI, 0.70-0.81) reduced the risk for ASCVD. Compared with placebo, BP-lowering therapy reduced the risk for coronary heart disease (RR, 0.84; 95% CI, 0.79-0.90) and stroke (RR, 0.64; 95% CI, 0.56-0.73). Tobacco cessation drugs increased the odds of continued abstinence at 6 months (odds ratio range, 1.82 [95% CI, 1.60-2.06] to 2.88 [95% CI, 2.40-3.47]), but the direct effects on ASCVD were poorly reported. Aspirin increased the risk for major bleeding (RR, 1.54; 95% CI, 1.30-1.82), and statins did not increase overall risk for adverse effects (RR, 1.00; 95% CI, 0.97-1.03). Adverse effects of BP-lowering therapy and tobacco cessation drugs were poorly reported.
CONCLUSIONS AND RELEVANCE
This overview demonstrates high-quality evidence to support aspirin, BP-lowering therapy, and statins for primary ASCVD prevention and tobacco cessation drugs for smoking cessation. Treatment effects of each drug can be used to enrich discussions between health care professionals and patients in primary ASCVD prevention.
Topics: Aspirin; Blood Pressure; Cardiovascular Diseases; Coronary Artery Disease; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Tobacco Use Cessation
PubMed: 27438118
DOI: 10.1001/jamacardio.2016.0218