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PURPOSE To compare the predictive ability of mapping algorithms derived using cross-sectional and longitudinal data. METHODS This methodological assessment used data from a randomized controlled noninferiority trial of patients with low-risk prostate cancer, conducted by NRG Oncology (ClinicalTrials.gov identifier: NCT00331773 ), which examined the efficacy of conventional schedule versus hypofractionated radiation therapy (three-dimensional conformal external beam radiation therapy/IMRT). Health-related quality-of-life data were collected using the Expanded Prostate Cancer Index Composite (EPIC), and health utilities were obtained using EuroQOL-5D-3L (EQ-5D) at baseline and 6, 12, 24, and 60 months postintervention. Mapping algorithms were estimated using ordinary least squares regression models through five-fold cross-validation in baseline cross-sectional data and combined longitudinal data from all assessment periods; random effects specifications were also estimated in longitudinal data. Predictive performance was compared using root mean square error. Longitudinal predictive ability of models obtained using baseline data was examined using mean absolute differences in the reported and predicted utilities. RESULTS A total of 267 (and 199) patients in the estimation sample had complete EQ-5D and EPIC domain (and subdomain) data at baseline and at all subsequent assessments. Ordinary least squares models using combined data showed better predictive ability (lowest root mean square error) in the validation phase for algorithms with EPIC domain/subdomain data alone, whereas models using baseline data outperformed other specifications in the validation phase when patient covariates were also modeled. The mean absolute differences were lower for models using EPIC subdomain data compared with EPIC domain data and generally decreased as the time of assessment increased. CONCLUSION Overall, mapping algorithms obtained using baseline cross-sectional data showed the best predictive performance. Furthermore, these models demonstrated satisfactory longitudinal predictive ability.

OBJECTIVE: To estimate the impact of implementing prescription drug monitoring program (PDMP) best practices on prescription opioid use. DATA SOURCES: 2007–2012 Medicare claims for noncancer pain patients, and PDMP attributes from the Prescription Drug Abuse Policy System. STUDY DESIGN: We derived PDMP composite scores using the number of best practices adopted by states (range: 0‐14), classifying states as either no PDMP, low strength (0

The advent of fecal microbiota transplantation (FMT) and the prospect of other types of microbiota transplants (MT), e.g. vaginal, skin, oral and nasal, are challenging regulatory agencies. Although FDA is regulating FMT (as a biologic), there is currently no widely accepted or agreed upon scientific or legal definition of FMT or MT. The authors report on discussions regarding a definition of MT that took place among a working group of stakeholders convened under a National Institutes for Allergies and Infectious Diseases grant to address the regulation of MT. In arriving at a definition, the group considered the 1) nature of the material being transplanted; 2) degree of manipulation of the transferred materials prior to implantation; 3) ability to characterize the transplanted product using external techniques; and 4) origin of the stool product (single vs multiple donors).

The Human Microbiome Project and similar research has generated great interest in potential health benefits of microbiota transplantations (MTs). The use of fecal microbiota transplantation (FMT), the transfer of stool from a human donor to a human recipient, for recurrent Clostridium difficile infection (CDI) is considered by many to be standard-of-care therapy, and data on its safety and effectiveness are accumulating ( 1 – 3 ). Yet, although some physicians are practicing FMT using stool from donors known to the physician or patient, stool is inconsistently screened for infectious pathogens. The use of prescreened stool obtained from a stool bank and shipped to the physician is increasing, but the stool banks are not regulated. Patients who self-administer FMT using unscreened stool sourced from family or friends is also widely described. In consideration of these and other particular characteristics and challenges of MT, and the nascent regulatory landscape, we convened human microbiome researchers, legal experts, and others to explore regulatory pathways for MT ( 4 ). We believe our proposed approach is an improvement on the U.S. Food and Drug Administration's (FDA) current and proposed scheme and could provide a model for other countries that are contemplating regulatory frameworks for FMT.

Background: Social media offer a novel avenue to engage with and recruit research participants. Facebook in particular is a promising option given its popularity and widespread use. Objective: To explore the feasibility of using Facebook to recruit physicians and patients to participate in a survey to assess their perceptions about generic venlafaxine extended release (ER) tablet indicated for depression. Methods: Web-based surveys were developed to gauge physicians’ prescribing experiences with and patients’ perceptions of generic venlafaxine ER tablet. The surveys included questions specific to venlafaxine ER tablets, such as perceived safety and efficacy of the drug and overall comfort level with either prescribing or taking the drug. Survey links were then posted and advertised on Facebook to recruit physicians and patients. Results: Advertisement for physicians reached 1898 Facebook users and advertisement for patients reached 1144 users during a 10-day advertising period. However, only 14 and 35 users clicked on the survey for physicians and patients, respectively. No physician completed the physician survey while 3 patients completed the patient survey. Conclusions: The findings of this study suggest that Facebook may not be an effective method to recruit physicians. Facebook holds promise to recruit patients, but additional recruitment efforts, such as incentives, are needed.

Objectives Use of patient provider agreements (PPAs) is increasing, yet there is limited evidence on the effectiveness of PPAs to prevent prescription opioid misuse and diversion, and few guidelines for providers. We conducted eight focus groups to understand patient and prescriber perceptions of PPAs. Methods We recruited 40 patients who had been asked to sign a PPA and 40 prescribers who had administered at least one PPA. We developed topic guides for the two groups based on prior literature. Focus groups were audio-recorded and transcribed verbatim. Two investigators independently performed the content analysis of the transcripts and reached consensus on recurring themes. Key findings PPA use varied according to physician specialty. General practitioners used PPAs the least but reported increasing pressure from liability insurers to use them. Many patients reported signing a PPA in the emergency room of a hospital. Prescribers and patients reported a lack of understanding among patients concerning the purpose and content of the PPA. Prescribers questioned the legal status of the PPA, while patients believed that the PPA was a legal document intended to protect prescribers. Patients and prescribers valued PPA content items differently, although both groups agreed that signing a PPA would not prevent opioid misuse. Conclusions We identified several themes concerning the administration, content, effectiveness and utility of PPAs that highlight areas of research to improve PPAs. We also describe trends requiring further investigation. Understanding content of importance to patients will facilitate the development of a patient-centred PPA.

As the leading health economics and outcomes research (HEOR) professional society, ISPOR has a responsibility to establish a uniform, harmonized international code for ethical conduct. ISPOR has updated its 2008 Code of Ethics to reflect the current research environment. This code addresses what is acceptable and unacceptable in research, from inception to the dissemination of its results. There are nine chapters: 1 – Introduction; 2 – Ethical Principles respect, beneficence and justice with reference to a non-exhaustive compilation of international, regional, and country-specific guidelines and standards; 3 – Scope HEOR definitions and how HEOR and the Code relate to other research fields; 4 – Research Design Considerations primary and secondary data related issues, e.g., participant recruitment, population and research setting, sample size/site selection, incentive/honorarium, administration databases, registration of retrospective observational studies and modeling studies; 5 – Data Considerations privacy and data protection, combining, verification and transparency of research data, scientific misconduct, etc.; 6 – Sponsorship and Relationships with Others (roles of researchers, sponsors, key opinion leaders and advisory board members, research participants and institutional review boards (IRBs) / independent ethics committees (IECs) approval and responsibilities); 7 – Patient Centricity and Patient Engagement new addition, with explanation and guidance ; 8 – Publication and Dissemination ; and 9 – Conclusion and Limitations .

Objectives Antipsychotic polypharmacy is increasingly prescribed despite little documented evidence of a therapeutic benefit. There is also a limited understanding of the role that health insurance plays on the prevalence of antipsychotic polypharmacy. This study was undertaken to investigate the relationship between antipsychotic polypharmacy and individuals' intended source of payment in a US national sample of ambulatory care patients. Methods The study combined 2002, 2003 and 2004 data from the National Ambulatory Medical Care Survey (NAMCS) among adults seeking outpatient-based physician medical care services in the USA. We investigated characteristic differences among patients who were prescribed multiple antipsychotics versus individuals receiving only a single antipsychotic medication. Multivariable logistic regression examined the association between antipsychotic polypharmacy and patients' primary payment type classified as private insurance, Medicaid, Medicare or other (primarily out-of-pocket) payment type. Key findings Use of more than one antipsychotic agent was recorded in 68 of 830 (8.2%) outpatient physician visits in the 3-year period 2002–2004. Among the payer types studied, Medicaid payment status was correlated with increased risk of antipsychotic polypharmacy (odds ratio 2.7, 95% confidence interval 1.1–6.7). Conclusions Insurance status was associated with antipsychotic polypharmacy among non-institutionalized US residents prescribed antipsychotic medications. Patients reporting Medicaid as their primary payer were nearly three times as likely to be prescribed multiple antipsychotic drugs, potentially increasing their risk of adverse side effects as well as greater taxpayer burden. Future research should determine whether these trends continued after 2004 and to determine the costs of treating patients in the public sector with multiple antipsychotic drugs, a common scenario despite financial pressures and uncertain medical benefit.

To test the hypotheses that African American patients and older patients with stage IV colorectal cancer were less likely to receive newer chemotherapy agents.Retrospective cohort design.Among 5068 Surveillance, Epidemiology, and End Results-Medicare patients diagnosed as having stage IV colorectal cancer between 2000 and 2002, a total of 2466 received chemotherapy and were included in the analysis. Irinotecan hydrochloride was the first of the "newer" chemotherapy agents and was marketed in 2000 as a first-line add-on agent. Descriptive statistics were generated, and a multivariable logistic regression was run to estimate the odds of receiving irinotecan among African American patients and older patients and within 2 months of chemotherapy initiation.African American patients had lower odds of initiating treatment with a newer chemotherapy than white patients (adjusted odds ratio, 0.641; 95% confidence interval, 0.453-0.907). An age disparity was also found, with all older age groups being significantly less likely to initiate treatment with a newer chemotherapy than the youngest age group: the adjusted odds of receiving newer chemotherapy agents (relative to patients aged 66-70 years) were lower and significant among patients aged 71 to 75, 76 to 80, and older than 80 years (odds ratios, 0.708, 0.527, and 0.213, respectively).Disparities in chemotherapy selection exist among patients receiving chemotherapy for stage IV colorectal cancer. On initiating chemotherapy, African American patients and older patients were less likely to receive a newer agent.

To examine the relative preferred placement of commonly dispensed prescription drugs and to assess variations in drug coverage across a convenience sample of 12 health insurance plans.A cross-sectional analysis of the plans focused on all 67 patented brand-name prescription drugs from among the top 200 prescribed drugs in 2004.For each plan, we created a preferred placement index representing the percentages of drugs that were positioned on the formulary with preferred placement, defined as tier 2 without restricted access. A separate cardiovascular index was also created. Sensitivity analyses determined the effect of limiting the sample to the top 25 patented branded drugs and examined the robustness of our index when prior authorization restrictions were allowed.Across 67 drugs and 12 insurance plans, drugs were rated as having preferred placement 59.1% of the time. The preferred placement index ranged from 31.3% to 88.1% across the plans for the full sample of 67 drugs; for the sample of cardiovascular drugs, the range was 25.0% to 100.0%. Results were robust across sensitivity analyses.Based on this convenience sample of 12 formularies, there is a wide variation in preferred placement of the most commonly prescribed branded medicines across insurers. The wide range implies that the specific insurance coverage a patient selects may have an effect on whether his or her prescribed drugs have preferred formulary placement and on his or her out-of-pocket drug expenditures.

In 2001, ISPOR convened a Task Force on Code of Ethics for Researchers (The Task Force). This Task Force was to build on the previous work of ISPOR Health Science Policy Task Forces and develop a code of ethics that would be applicable to all ISPOR members and to ISPOR itself. The Task Force developed a code of ethics that was subsequently adopted by the ISPOR Board of Directors. The Code of Ethics is appended to this article and can be found on ISPOR's Web page at http://www.ispor.org/workpaper/code_ethic.htm. This article provides supportive information and justification for the ISPOR Code of Ethics for Researchers and includes a discussion of the stakeholders as well as ethical considerations for the researcher on research practices, research sponsorship, research publication and dissemination, and relationships with others. It also includes a discussion of the ethical considerations for the Society.

This paper describes an operational computer-based system for conducting Drug Prescribing Review (DPR). The system was designed to: arrive at specific judgements about the potential problems of drug orders taking into account the characteristics of the patient and their medical conditions; be relatively independent of the structure of the data base; and be capable of expressing and evaluating any DPR criteria. This was accomplished by developing a hierarchical, rule-based system for expressing and evaluating DPR criteria. This system was then linked with a specific patient data base for implementation. Drug orders for 65 patients have been evaluated and the results agree with expert judgement. The rule-based DPR system appears to be a feasible method of evaluation of drug orders.