Conflict of interest in oncology publications: a survey of disclosure policies and statements.

BACKGROUND: Disclosure of conflicts of interest in biomedical research is receiving increased attention. The authors sought to define current disclosure policies and how they relate to disclosure statements provided by authors in major oncology journals. METHODS: The authors identified all oncology journals listed in the Thomson Institute for Scientific Information and sought their policies on conflict-of-interest disclosure. For a subset of journals with an Impact Factor >2.0, they catalogued the number and type of articles and the details of the published disclosures in all papers from the 2 most recent issues. RESULTS: Disclosure policies were provided by 112 of 131 journals (85%); 99 (88%) of these requested that authors disclose conflicts of interest (mean Impact Factor for these journals: 4.6), whereas the remaining 13 (12%) did not (mean Impact Factor: 2.9). Ninety-three journals (94%) required financial disclosure, and 42 (42%) also sought nonfinancial disclosures. For a subset of 52 higher-impact journals (Impact Factor >2.0), we reviewed 1734 articles and identified published disclosures in 51 journals (98%). Many of these journals (31 of 51, 61%) included some disclosure statement in >90% of their articles. Among 27 journals that published editorials/commentaries, only 14 (52%) included disclosures with such articles. There was no publication of any nonfinancial conflicts of interest in any article reviewed. CONCLUSIONS: Disclosure policies and the very definition of conflict of interest varied considerably among journals. Although most journals had some policy in this area, a substantial proportion did not publish disclosure statements consistently, with deficiencies particularly among editorials and commentaries.

Targeting cardiovascular medication adherence interventions.

OBJECTIVES: To determine whether adherence interventions should be administered to all medication takers or targeted to nonadherers. DATA SOURCES AND STUDY SELECTION: Systematic search (Medline and Embase, 1966-2009) of randomized controlled trials of interventions to improve adherence to medications for preventing or treating cardiovascular disease or diabetes. DATA EXTRACTION: Articles were classified as (1) broad interventions (targeted all medication takers), (2) focused interventions (targeted nonadherers), or (3) dynamic interventions (administered to all medication takers; real-time adherence information targets nonadherers as intervention proceeds). Cohen's d effect sizes were calculated. DATA SYNTHESIS: We identified 7,190 articles; 59 met inclusion criteria. Broad interventions were less likely (18%) to show medium or large effects compared with focused (25%) or dynamic (32%) interventions. Of the 33 dynamic interventions, 6 used externally generated adherence data to target nonadherers. Those with externally generated data were less likely to have a medium or large effect (20% vs. 34.8% self-generated data). CONCLUSION: Adherence interventions targeting nonadherers are heterogeneous but may have advantages over broad interventions. Dynamic interventions show promise and require further study.

Physician effectiveness in interventions to improve cardiovascular medication adherence: a systematic review.

BACKGROUND: Medications for the prevention and treatment of cardiovascular disease save lives but adherence is often inadequate. The optimal role for physicians in improving adherence remains unclear. OBJECTIVE: Using existing evidence, we set the goal of evaluating the physician's role in improving medication adherence. DESIGN: We conducted systematic searches of English-language peer-reviewed publications in MEDLINE and EMBASE from 1966 through 12/31/2008. SUBJECTS AND INTERVENTIONS: We selected randomized controlled trials of interventions to improve adherence to medications used for preventing or treating cardiovascular disease or diabetes. MAIN MEASURES: Articles were classified as either (1) physician "active"-a physician participated in designing or implementing the intervention; (2) physician "passive"-physicians treating intervention group patients received patient adherence information while physicians treating controls did not; or (3) physicians noninvolved. We also identified studies in which healthcare professionals helped deliver the intervention. We did a meta-analysis of the studies involving healthcare professionals to determine aggregate Cohen's D effect sizes (ES). KEY RESULTS: We identified 6,550 articles; 168 were reviewed in full, 82 met inclusion criteria. The majority of all studies (88.9%) showed improved adherence. Physician noninvolved studies were more likely (35.0% of studies) to show a medium or large effect on adherence compared to physician-involved studies (31.3%). Among interventions requiring a healthcare professional, physician-noninvolved interventions were more effective (ES 0.47; 95% CI 0.38-0.56) than physician-involved interventions (ES 0.25; 95% CI 0.21-0.29; p < 0.001). Among physician-involved interventions, physician-passive interventions were marginally more effective (ES 0.29; 95% CI 0.22-0.36) than physician-active interventions (ES 0.23; 95% CI 0.17-0.28; p = 0.2). CONCLUSIONS: Adherence interventions utilizing non-physician healthcare professionals are effective in improving cardiovascular medication adherence, but further study is needed to identify the optimal role for physicians.

Restrictions on antidepressant medications for children: a review of Medicaid policy.

OBJECTIVE: This study evaluated Medicaid's prior-authorization policies restricting the prescribing of antidepressant medications for children. METHODS: Medicaid program prior-authorization policies for antidepressant medications were obtained for all available states. All criteria needed for authorization were recorded, with a focus on policies that applied specifically to children. RESULTS: Data from 49 states and the District of Columbia revealed that 30 states (60%) required prior authorization for antidepressants, of which eight (27%) made specific provisions for children. These provisions varied across states. In most states fluoxetine could be prescribed for children with minimal restrictions, and two states had prior-authorization policies that strongly encouraged pediatric patients to use fluoxetine. State policies regarding other selective serotonin reuptake inhibitors varied widely. CONCLUSIONS: Although relatively few states included provisions for children in prior-authorization requirements for antidepressants, in states that did, the policies implemented varied widely. These findings raise important questions about the rational development of prescription drug reimbursement policy.

Factors affecting adherence to osteoporosis medications: a focus group approach examining viewpoints of patients and providers.

PURPOSE: This qualitative study uses a focus group approach to determine factors influencing adherence to osteoporosis medications among older adults. Thirty-two patients aged 65 to 85 years from the Greater Boston area who were prescribed an osteoporosis medication, 11 general medicine physicians, and 1 nurse practitioner were recruited from Boston-based hospitals affiliated with a large health care system. METHOD: Focus groups consisting of 6 to 8 subjects including men and women were held separately for providers and patients and conducted until thematic saturation was reached. Responses were obtained from patients and providers during the focus group interviews conducted by a trained focus group moderator. All interviews were audio taped and transcribed by a medical transcriptionist. RESULTS: According to patients, factors affecting adherence to osteoporosis drugs included lack of knowledge about osteoporosis, dissatisfaction with their doctor visits, side effects, and difficulty or failure to remember instructions for taking medications. Physicians reported lack of patient knowledge, structural barriers, medication side effects, and the inability to track patients' adherence to their medications as barriers to adherence. CONCLUSION: This study identifies the extent of and reasons for nonadherence as perceived by patients and providers and provides insights into strategies to modify treatment plans to address nonadherence. The results from this study were used to develop a randomized controlled trial to conduct and evaluate patient- and physician-targeted interventions to improve adherence to osteoporosis medications and to examine cost-effectiveness of alternative strategies.

Validation of rheumatoid arthritis diagnoses in health care utilization data.

INTRODUCTION: Health care utilization databases have been increasingly used for studies of rheumatoid arthritis (RA). However, the accuracy of RA diagnoses in these data has been inconsistent. METHODS: Using medical records and a standardized abstraction form, we examined the positive predictive value (PPV) of several algorithms to define RA diagnosis using claims data: A) at least two visits coded for RA (ICD-9, 714); B) at least three visits coded for RA; and C) at least two visits to a rheumatologist for RA. We also calculated the PPVs for the subgroups identified by these algorithms combined with pharmacy claims data for at least one disease-modifying anti-rheumatic drug (DMARD) prescription. RESULTS: We invited 9,482 Medicare beneficiaries with pharmacy benefits in Pennsylvania to participate; 2% responded and consented for review of their medical records. There was no difference in characteristics between respondents and non-respondents. Using 'RA diagnosis per rheumatologists' as the gold standard, the PPVs were 55.7% for at least two claims coded for RA, 65.5% for at least three claims for RA, and 66.7% for at least two rheumatology claims for RA. The PPVs of these algorithms in patients with at least one DMARD prescription increased to 86.2%-88.9%. When fulfillment of 4 or more of the ACR RA criteria was used as the gold standard, the PPVs of the algorithms combined with at least one DMARD prescriptions were 55.6%-60.7%. CONCLUSIONS: To accurately identify RA patients in health care utilization databases, algorithms that include both diagnosis codes and DMARD prescriptions are recommended.

Modes of delivery for interventions to improve cardiovascular medication adherence.

OBJECTIVE: To determine the optimal modes of delivery for interventions to improve adherence to cardiovascular medications. STUDY DESIGN: Systematic review. METHODS: We conducted systematic searches of English-language, peer-reviewed publications in MEDLINE and EMBASE, 1966 through December 31, 2008. We selected randomized controlled trials of interventions to improve adherence to medications for preventing or treating cardiovascular disease or diabetes. Articles were classified based on mode of delivery of the main intervention as (1) person-independent interventions (mailed, faxed, or hand distributed; or delivered via electronic interface) or (2) person-dependent interventions (nonautomated phone calls, in-person interventions). RESULTS: We identified 6550 articles. Of these, 168 were reviewed in full and 51 met inclusion criteria. Among person-independent interventions (56% successful), electronic interventions were most successful (67%). Among person-dependent interventions (52% successful), phone calls showed low success rates (38%). In-person interventions at hospital discharge were more effective (67%) than clinic interventions (47%). In-person pharmacist interventions were effective when held in a pharmacy (83% successful), but were less effective in clinics (38%). CONCLUSIONS: Future medication adherence studies should explore new electronic approaches and in-person interventions at the site of medication distribution. Identifying times of increased patient receptivity to the adherence message such as hospital discharge also will be important.

Prior authorization for biologic disease-modifying antirheumatic drugs: a description of US Medicaid programs.

OBJECTIVE: To evaluate state Medicaid prior authorization programs for biologic disease-modifying antirheumatic drugs (DMARDs). METHODS: We obtained biologic DMARD prior authorization policy information from state Medicaid programs. Using aggregate Medicaid drug spending data, we calculated the proportion of DMARD prescriptions and spending attributed to adalimumab and etanercept in 1999 and 2005 and compared the changes in these proportions in states with and without prior authorization policies. Infliximab and other infused DMARDs were not included because of substantial missing data. RESULTS: Thirty-two states required prior authorization for > or = 1 biologic DMARD, with wide variation in the specific agents covered and the criteria required for a drug to be authorized. There were 18 states with prior authorization requirements for adalimumab or etanercept. States that implemented prior authorization for these agents initially had lower use of the targeted medications, but use increased over time to a level similar to that in states that did not have prior authorization requirements. CONCLUSION: States vary widely in their implementation of prior authorization policies to limit use of biologic DMARDs. Although it appears that these policies may have a short-term effect on the use of targeted medications, this effect does not appear to be sustained. The clinical impact and appropriateness of such policies is not clear from our data and should be studied further.