Effects of congressional modernization laws on public access to innovative medical device technologies

The Federal Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid (CMS) play key roles in making Class III, medical devices available to the public, and they are required by law to meet statutory deadlines for applications under review. Historically, both agencies have failed to meet their respective statutory requirements. Since these failures affect patient access and may adversely impact public health, Congress has enacted several “modernization” laws. However, the effectiveness of these modernization laws has not been adequately studied or established for Class III medical devices. ^ The aim of this research study was, therefore, to analyze how these modernization laws may have affected public access to medical devices. Two questions were addressed: (1) How have the FDA modernization laws affected the time to approval for medical device premarket approval applications (PMAs)? (2) How has the CMS modernization law affected the time to approval for national coverage decisions (NCDs)? The data for this research study were collected from publicly available databases for the period January 1, 1995, through December 31, 2008. These dates were selected to ensure that a sufficient period of time was captured to measure pre- and post-modernization effects on time to approval. All records containing original PMAs were obtained from the FDA database, and all records containing NCDs were obtained from the CMS database. Source documents, including FDA premarket approval letters and CMS national coverage decision memoranda, were reviewed to obtain additional data not found in the search results. Analyses were conducted to determine the effects of the pre- and post-modernization laws on time to approval. Secondary analyses of FDA subcategories were conducted to uncover any causal factors that might explain differences in time to approval and to compare with the primary trends. The primary analysis showed that the FDA modernization laws of 1997 and 2002 initially reduced PMA time to approval; after the 2002 modernization law, the time to approval began increasing and continued to increase through December 2008. The non-combined, subcategory approval trends were similar to the primary analysis trends. The combined, subcategory analysis showed no clear trends with the exception of non-implantable devices, for which time to approval trended down after 1997. The CMS modernization law of 2003 reduced NCD time to approval, a trend that continued through December 2008. This study also showed that approximately 86% of PMA devices do not receive NCDs. ^ As a result of this research study, recommendations are offered to help resolve statutory non-compliance and access issues, as follows: (1) Authorities should examine underlying causal factors for the observed trends; (2) Process improvements should be made to better coordinate FDA and CMS activities to include sharing data, reducing duplication, and establishing clear criteria for “safe and effective” and “reasonable and necessary”; (3) A common identifier should be established to allow tracking and trending of applications between FDA and CMS databases; (4) Statutory requirements may need to be revised; and (5) An investigation should be undertaken to determine why NCDs are not issued for the majority of PMAs. Any process improvements should be made without creating additional safety risks and adversely impacting public health. Finally, additional studies are needed to fully characterize and better understand the trends identified in this research study.^

An interactive intervention to impact adherence to antiretroviral treatment among treatment-naive HIV-infected adults in Thailand: A pilot randomized controlled study

Background. Consistent adherence to antiretroviral treatment is necessary for a treatment success. Improving and maintaining adherence rate >95% are challenging for health care professionals. This pilot randomized controlled study aimed to evaluate the impact of the interactive intervention on adherence to GPO-VIR, to describe the feasibility of the interactive intervention in Thailand, and to illustrate the adherence self-efficacy concept among HIV treatment-naïve patients in Thailand who were starting antiretroviral treatment. ^ Methods. The study took place at three HIV clinics located in Phayao, Thailand. Twenty-three patients were randomly assigned into the experimental (n=11) and the control groups (n=12). Each participant in the experimental group and a significant person to the patient received 5 educational sessions with a nurse at the clinics and at their homes. They also received 3 follow-up evaluations during the 6-month period of the study. The participants in the control group received the standard of care provided by HIV clinical personnel plus three follow-up evaluations at the clinic. ^ Results. Seventeen patients (7 in the experimental and 10 in the control group) completed the study. The 4-day recall on the Thai ACTG Adherence Scale demonstrated adherence rate >95% for most participants from both groups. After the first measurement, no experimental group patients reporting missing ART, while one control group participant continuously skipped ART. Participants from both groups had significantly increased CD4 cell counts after the study (F(1, 15) = 29.30, p = .000), but no differences were found between two groups (F(1, 15) = .001, p = .98). Examination of the intervention showed limitations and possibilities to implement it in Thailand. Qualitative data demonstrated self-efficacy expectations, resignation and acceptance as related concepts to improve adherence outcomes. ^ Conclusions. This interactive intervention, after appropriate modifications, is feasible to apply for Thai HIV-treatment naïve patients. Because of limitations the study could not demonstrate whether the interactive intervention improved adherence to ART among HIV-treatment naïve in Thailand. A longitudinal study in a larger sample would be required to test the impact of the intervention. ^ Keyword: antiretroviral treatment, adherence, treatment-naïve, Thailand, randomized controlled study ^

Hispanic incorporation and access to health care in Houston and Harris County, Texas: Adopting an Hispanic perspective to the Aday and Andersen model

This study examines Hispanic levels of incorporation and access to health care. Applying the Aday and Andersen framework for the study of access, the study examined the relationship between two levels of Hispanic incorporation into U.S. society, i.e., mainstream versus ethnic, and potential and realized measures of access to health care. Data for the study were drawn from a 1992 telephone survey of 600 randomly selected Hispanics in Houston and Harris County.^ The hypotheses tested were: (1) Hispanics who are incorporated into mainstream society are more likely to have better potential and realized access to health care than those who are incorporated into ethnic-group enclaves regardless of their socioeconomic status (SES), health status and health needs, and (2) there is no interaction between the levels of incorporation (mainstream or ethnic) and SES, health status, and health needs in predicting potential and realized access.^ The data analysis supported Hypothesis One for the two measures of potential access. The results of bivariate and multiple logistic regression analyses indicated that for Hispanics in Houston and Harris County, being in the "mainstream" incorporation category increased their potential access to care, having "health insurance" and a "regular place of care". For the selected measure of realized access, having a "regular check-up", the analysis did not demonstrate statistically significant differences in having a regular check-up among Hispanics incorporated in the ethnic or mainstream incorporation categories.^ Hypothesis Two, that there is no interaction between the levels of incorporation and socioeconomic characteristics, health status, and health needs in predicting potential and realized access among Hispanics was supported by the data. The results of the logistic regression analysis showed that, after adjusting for socioeconomic status, health status, and health needs, the association between "level of incorporation" and the two measures of potential access ("health insurance" and having a "usual place of care") was not modified by the control variables nor by their interaction with level of incorporation. That is, the effect of incorporation on Hispanics' health insurance coverage, and having a usual place of care, was homogenous across Hispanics with different SES and health status.^ The main research implication of this dissertation is the employment of a theoretical framework for the assessment of cultural factors essential to research on migrating heterogeneous subpopulations. It also provided strategies to solve practical and methodological difficulties in the secondary analyses of data on these populations. ^

FACTORS INFLUENCING ACCESS TO HEALTH CARE AMONG MEXICAN AMERICAN ELDERLY IN TEXAS

Differential access to health care services has been observed among various groups in the United States. Minorities and low-income groups have been especially notable in their decreased access to regular providers of care. This is believed by many to account for some of the higher rates of morbidity and mortality and shorter life expectancies of these groups.^ This research delineated the factors associated with health care access for a particular subset of a minority group, the Mexican American elderly in Texas. Hospital admission and evidence of a regular source of medical care and dental care were chosen as the indicators of access to health care.^ This study analyzed survey interview data from the Texas Study on Aging, 1976. The 597 Mexican American elderly included in this study were representative of the non-institutionalized Mexican American elderly in Texas aged 55 or older.^ The results indicate that hospital admission is not a question of discretion and that common barriers to access, such as income, health insurance, and distance to the nearest facility, are not important in determining hospital admission. Mexican American elderly who need to be hospitalized, as indicated by self-perception of health and disability days, will be hospitalized.^ The results also indicate that having a regular source of medical care is influenced by many factors, some mutable and some immutable. The well-established and immutable factors of age, sex, and need were confirmed. However, the mutable factors such as area of residence and income were also found to have a significant influence. Mexican American elderly living in urban areas had significantly less access to a regular source of medical care as did those who were near the poverty level (as opposed to those who were well below the poverty level). In general, persons claiming a regular source of medical care were more likely to be women, persons who had many health needs, were near the poverty level, lived in urban areas, and had extensive social support systems.^ Persons claiming a regular source of dental care tended to be more advantaged. They had more education, a more extensive informal social support network, higher income, and were generally younger and in better health. They were also more likely to have private health insurance. . . . (Author's abstract exceeds stipulated maximum length. Discontinued here with permission of author.) UMI ^

Access to oral care --- A systematic review of a continuing public health issue among older adults

Oral health is essential for the general well being of the individual and collectively for the health of the population. Oral health can be maintained by routine dental care and visits to dental professionals, but accessing professional dental care may be a continuing difficulty in vulnerable older adult population. Many older adults are not frequent users of dental care, though oral health is crucial to their well-being and overall health. Access to care is the timely use of personal health services to achieve the best possible health outcomes. ^ Objectives: The aims of this review are to (i) to analyze and elucidate the relationship between socio-economic disparities in gender, ethnicity, poverty status, education and the continuing public issue of access to oral care, (ii) to identify the underlying causes through which these factors can affect access to oral care. This review will provide a knowledgeable basis for development of interventions to provide adequate access to oral care in older adults and implementing policies to ensure access to oral care; through highlighting the various socio economic factors that affect access to oral care among older adults. ^ Methods: This paper used a purposeful review of literature on socioeconomic disparities in access to oral care among older adults. The references considered in this review included all the relevant articles, surveys and reports published in English language, since the year 1985 to 2010, in the United States. The articles selected were scrutinized for relevancy to the topic of access to oral care and which included discussions of the effects of gender, ethnicity, poverty status, educational status in accessing oral care. ^ Results: Evidence confirmed the continuing disparity in access to oral care among older adults. The possible links identified were gender inequality, ethnic differences, income levels and educational differences affecting access to oral care. The underlying causes linking these factors with access to oral care were established. ^ Conclusion: The analysis of the literature review findings supported the prevalence of disparities in gender, ethnicity, income and education with its possible links affecting access to oral care. The underlying causes helped to understand the reasons behind this growing issue of inaccessible oral care. Further research is needed to develop policies and target dental public health efforts towards specific problem areas ensuring equitable access to oral services and consequently, improve the health of older adults.^

Evaluation of the impact of access to free influenza vaccine on immunization rates for children with cystic fibrosis

Children with cystic fibrosis are at increased risk of seasonal influenza associated complications, which makes them a judicious target of interventions designed to increase influenza vaccination rates. The Baylor College of Medicine/Texas Children's Hospital Pediatric Cystic Fibrosis (BCM/TCH CF) Care Center implemented an enhanced multi-component initiative designed to increase influenza vaccination rates in its patient population during the 2011-2012 influenza season. We evaluated the impact of specific components of this intervention on vaccination rates among the clinic's patient population via a historical medical chart review and examined the relationship between vaccination status and the number of pulmonary exacerbations requiring hospital admission during the influenza season. The multi-component intervention was comprised of providing influenza free of charge in the CF Care Center, reminders via phone call and letters, and drive through influenza vaccine clinics on nights and weekends. The intervention to increase influenza vaccination rates led to overall improved vaccination rates among the patients at the BCM/TCH CF Care Center, increasing from 90% adherence observed during the 2010-2011 season to 94% adherence during the 2011-2012 season. The availability of free influenza vaccine in the CF Care Center, combined with reminders about being vaccinated early in the season proved to be the most effective practices for improving the vaccination rate in the CF Care Center.^

Misoprostol in addition to routine treatment of postpartum hemorrhage: A hospital-based randomized-controlled trial in Karachi, Pakistan

Background: Postpartum hemorrhage (PPH) remains a major killer of women worldwide. Standard uterotonic treatments used to control postpartum bleeding do not always work and are not always available. Misoprostol's potential as a treatment option for PPH is increasingly known, but its use remains ad hoc and available evidence does not support the safety or efficacy of one particular regimen. This study aimed to determine the adjunct benefit of misoprostol when combined with standard oxytocics for PPH treatment. Methods: A randomized controlled trial was conducted in four Karachi hospitals from December 2005 – April 2007 to assess the benefit of a 600 mcg dose of misoprostol given sublingually in addition to standard oxytocics for postpartum hemorrhage treatment. Consenting women had their blood loss measured after normal vaginal delivery and were enrolled in the study after losing more than 500 ml of blood. Women were randomly assigned to receive either 600 mcg sublingual misoprostol or matching placebo in addition to standard PPH treatment with injectable oxytocics. Both women and providers were blinded to the treatment assignment. Blood loss was collected until active bleeding stopped and for a minimum of one hour after PPH diagnosis. Total blood loss, hemoglobin measures, and treatment outcomes were recorded for all participants. Results: Due to a much lower rate of PPH than expected (1.2%), only sixty-one patients were diagnosed and treated for their PPH in this study, and we were therefore unable to measure statistical significance in any of the primary endpoints. The addition of 600 mcg sublingual misoprostol to standard PPH treatments does, however, suggest a trend in reduced postpartum blood loss, a smaller drop in postpartum hemoglobin, and need for fewer additional interventions. Women who bled less overall had a significantly smaller drop in hemoglobin and received fewer additional interventions. There were no hysterectomies or maternal deaths among study participants. The rate of transient shivering and fever was significantly higher among women receiving misoprostol Conclusion: A 600 mcg dose of misoprostol given sublingually shows promise as an adjunct treatment for PPH and its use should continue to be explored for its life-saving potential in the care of women experiencing PPH. Trial Registration: Clinical trials.gov, Registry No. NCT00116480

Minors’ Access to Contraceptive Services

Over the past 30 years, states have expanded minors’ authority to consent to health care, including care related to sexual activity. This trend reflects U.S. Supreme Court rulings extending the constitutional right to privacy to a minor’s decision to obtain contraceptives and concluding that rights do not “come into being magically only when one attains the state-defined age of majority.” It also reflects the recognition that while parental involvement is desirable, many minors will remain sexually active but not seek services if they have to tell their parents. As a result, confidentiality is vital to ensuring minors’ access to contraceptive services. Even when a state has no relevant policy or case law, physicians may commonly provide medical care to a mature minor without parental consent, particularly if the state allows a minor to consent to related health services.

Working to improve access to safe abortion

Presentación en la 4ta. Conferencia Regional del CLACAI. Reafirmando el legado de Cairo: Aborto legal y seguro. Lima, 21 y 22 de Agosto de 2014

Foctors that prevent children from gaining access to schooling : a study of Delhi Slum households

This paper examines the factors that prevent slum children aged 5 to 14 from gaining access to schooling in light of the worsening urban poverty and sizable increase in rural-to-urban migration. Bias against social disadvantage in terms of gender and caste is not clearly manifested in schooling, while migrated children are less likely to attend school. I argue that the lack of preparation for schooling in the pre-schooling ages and school admission procedures are the main obstacles for migrated children. The most important implication for universal elementary education in urban India is raising parental awareness and simplifying the admission procedures.

Did the least developed countries benefit from duty-free quota-free access to the Japanese market?

Countries classified as least developed countries (LDCs) were granted duty-free quota-free (DFQF) access to the Japanese market. This study examines the impact of that access and finds that, in general, it did not benefit the LDCs. The construction of concordance tables for Japan's 9 digit tariff line codes enables analysis at the tariff line level, which overcomes a possible aggregation bias. The exogenous nature of DFQF access mitigates the endogeneity problem. Various estimation models, including the triple difference estimator, show that in general the LDCs did not benefit from DFQF access to the Japanese market. The total value of imports from LDCs has been increasing, but the imports granted both zero tariffs and substantial preference margins over non-LDC countries were not successful. These findings suggest that for LDCs the tariff barrier is a relatively small obstacle: Trade is affected more strongly by other factors, such as infrastructure, nontariff barriers, geographic distance, and cultural differences.

Aiming at improving access to research output through the institutional repository

The paper is to introduce the institutional repository (IR) as a powerful tool to support the researchers of the institution to archive and disseminate their research findings freely to the scholarly community on the Internet. The IR can improve the access to an institution’s research output enormously. The operations of an IR also require various interactions with researchers, which enables the library to gain a solid understanding of research needs and expectations. Through such interaction, the relationship and mutual trust between researchers and the library are strengthened. The experiences of the Institute of Developing Economies (IDE) library can be useful to other special libraries.