Advancing women, parity, and gender equity.

For centuries, society has called out for transformations to lift all of its members. While it may seem ordinary in our time for women to be dentists or dental educators, the path was neither always easy, nor has true equity been achieved. The modern transformation of dental education and dentistry creates the need for leaders to propose and develop concrete initiatives to advance the profession and benefit society. Areas to address that could lead to increased equity for women include career advancement, leadership opportunities, compensation, career satisfaction, research, and scholarly activity. Our analysis demonstrates that even though the number of full-time female faculty has increased during recent years, most positions (59.5%) at dental schools in the US are held by men (2018-2019). Males were also compensated at higher rates than their female counterparts, and female deans made 7% less in total compensation. Because disparities are evident in pay and academic pathways, new directions and strategies must be employed to ensure parity and gender equity. Facilitating the progress of women in organized dentistry requires efforts of dental academic institutions to invest resources and provide nurturing environments that promote professional performances and leadership skills for women, with these being priorities-considering the current trends that anticipate increased numbers of women in dental academia. All dentists bring their own experiences to the profession, making for rich depth and diversity. As a collective voice, we have a bright future. We can and will move forward together.

The risk of melanoma with rasagiline compared with other antiparkinsonian medications: A retrospective cohort study in the United States medicare database.

PURPOSE: Compare the risk of melanoma between initiators of rasagiline or other antiparkinsonian drugs (APDs) in a Parkinson's disease (PD) population. METHODS: A retrospective cohort study was conducted in the US Medicare claims research database (2006-2015) in adults aged ≥65 years with PD claims. Other APD initiators were randomly matched (4:1) to rasagiline initiators on age, sex, and cohort entry year. Cutaneous melanoma events were identified by a validated claims algorithm. Incidence rates (IRs), incidence rate ratios (IRRs), and Cox-adjusted hazard ratios (HRs) for melanoma comparing rasagiline with other APD initiators were calculated and analyzed by duration of study medication use and cumulative dose of rasagiline. Potential indicators of surveillance bias were explored. RESULTS: Among 23 708 rasagiline initiators and 96 552 matched APD initiators, the crude IR of melanoma/100 000 person-years was 334.3 (95% confidence interval [CI], 291.5-381.6) and 208.2 (95% CI, 190.1-227.5), respectively (crude IRR 1.61; 95% CI, 1.36-1.89). The adjusted HR was 1.37 (95% CI, 1.14-1.65) and increased with longer rasagiline exposure and higher cumulative rasagiline doses. Rasagiline initiators more frequently had dermatologist visits or skin biopsies before cohort entry than APD initiators and had a higher incidence of nonmelanoma skin cancer during follow-up (crude IRR, 1.44; 95% CI, 1.35-1.54). CONCLUSIONS: A small increased incidence of melanoma with exposure to rasagiline compared with other APDs was observed. Although the pattern with dose and duration is consistent with a hypothesized biologic effect, the increased skin cancer surveillance among rasagiline users suggests surveillance bias as a contributing explanation for the observed results.

Assessing the incidence of osteosarcoma among teriparatide users based on Medicare Part D and US State Cancer Registry Data.

PURPOSE: During preclinical testing, teriparatide caused a dose-dependent increase in the incidence of osteosarcoma in rats. This study compared the incidence rate of osteosarcoma among patients aged ≥65 years treated with teriparatide vs a matched-comparator cohort. METHODS: This population-based comparative-cohort study matched exposure details for each teriparatide user, identified via Medicare Part D prescription claims, and up to four comparators based on age, sex, zip code, date of claim for filled prescription, and number of unique therapeutic classes dispensed. Outcomes were identified via linkage with participating cancer registries. All US state cancer registries were invited to participate. RESULTS: Overall, 153 316 patients in the teriparatide cohort and 613 247 in the comparator cohort were linked to 811 osteosarcoma cases from 26 participating state cancer registries (68% of US patients aged ≥65 years diagnosed 2007-2014). Analysis on a subset of cohorts revealed they were balanced for known osteosarcoma risk factors and Charlson comorbidity index. Mean duration of teriparatide treatment was 10 months. No osteosarcoma cases were observed in the teriparatide cohort; the incidence rate in the comparator cohort was consistent with the background incidence rate among adults aged ≥65 years. The incidence rate ratio was 0.0 (95% confidence interval, 0.0-3.2). CONCLUSIONS: For US patients aged ≥65 years, incidence of osteosarcoma among those treated with teriparatide ranges from 0 to 3.2 times the incidence of osteosarcoma in those treated with other medications. Given low incidence of osteosarcoma, this range of effect is inconsistent with a large absolute increase in osteosarcoma risk.

Growing up in Bradford: protocol for the age 7-11 follow up of the Born in Bradford birth cohort.

BACKGROUND: Born in Bradford (BiB) is a prospective multi-ethnic pregnancy and birth cohort study that was established to examine determinants of health and development during childhood and, subsequently, adult life in a deprived multi-ethnic population in the north of England. Between 2007 and 2010, the BiB cohort recruited 12,453 women who experienced 13,776 pregnancies and 13,858 births, along with 3353 of their partners. Forty five percent of the cohort are of Pakistani origin. Now that children are at primary school, the first full follow-up of the cohort is taking place. The aims of the follow-up are to investigate the determinants of children's pre-pubertal health and development, including through understanding parents' health and wellbeing, and to obtain data on exposures in childhood that might influence future health. METHODS: We are employing a multi-method approach across three data collection arms (community-based family visits, school based physical assessment, and whole classroom cognitive, motor function and wellbeing measures) to follow-up over 9000 BiB children aged 7-11 years and their families between 2017 and 2021. We are collecting detailed parent and child questionnaires, cognitive and sensorimotor assessments, blood pressure, anthropometry and blood samples from parents and children. Dual x-ray absorptiometry body scans, accelerometry and urine samples are collected on subsamples. Informed consent is collected for continued routine data linkage to health, social care and education records. A range of engagement activities are being used to raise the profile of BiB and to disseminate findings. DISCUSSION: Our multi-method approach to recruitment and assessment provides an efficient method of collecting rich data on all family members. Data collected will enhance BiB as a resource for the international research community to study the interplay between ethnicity, socioeconomic circumstances and biology in relation to cardiometabolic health, mental health, education, cognitive and sensorimotor development and wellbeing.

Evaluation of Physician Knowledge of the Key Safety Information for Aflibercept in Canada: Evaluation of Risk-Minimization Measures.

BACKGROUND: As part of the risk-management plan (RMP) for aflibercept, materials have been developed to educate physicians in Canada on the key safety information and safe use for aflibercept. OBJECTIVE: The objectives of this study were to assess whether physicians in Canada received and reviewed the aflibercept educational materials (i.e. vial preparation instruction card, intravitreal injection procedure video, and product monograph) and to evaluate their knowledge of key safety information. METHODS: Retinal specialists and ophthalmologists who prescribe and/or administer aflibercept were recruited to complete a survey. Physicians could complete and return a paper questionnaire by mail or complete the questionnaire online via a study website. RESULTS: Of the 308 physicians invited to participate in the survey, 95 (31%) completed the questionnaire. Nearly all physicians (98%) reported receiving at least one of the educational materials. The proportion of correct responses to individual questions on storage and preparation of aflibercept ranged from 54 to 98%. Physician knowledge was high on the recommended dose of aflibercept (91%), dose preparation (91-96% on individual items), and dosing guidelines (75-95% on individual items). Most physicians knew the contraindications for aflibercept (89%) and that aflibercept should not be used in pregnancy unless clearly indicated by medical need in which benefits outweigh risks (60%); 21% responded more conservatively that aflibercept should never be used in pregnancy. Knowledge was high for most questions about injection procedures (91-99% on individual items); however, fewer physicians (24%) correctly reported that the eye should be covered with a sterile drape. Knowledge was high for possible side effects (89-100% on individual items) and actions to take in relation to the potential for increased intraocular pressure (86-93% on individual items). CONCLUSION: Nearly all physicians (98%) reported having received the product monograph, and most (82%) reported having received the vial preparation instruction card; nearly half (46%) reported having received the intravitreal injection procedure video. Physicians' knowledge of the most important topics was high. Knowledge varied for topics that are less frequently encountered (e.g. use in women of childbearing potential) and for recommendations that are not standard medical practice in Canada (e.g. use of sterile drape).

Cognitive interviewing in risk minimization survey development: patient and healthcare professional surveys.

Risk minimization programs are often required for selected drugs and other products to ensure that the benefits of these prescription products outweigh their risks. Regulators in the USA and Europe have recently called for more rigorous standards in developing measures for risk minimization program assessment. Cognitive pretesting interviews are a critical step in the development of survey instruments used to evaluate patients' and healthcare professionals' knowledge and behaviors associated with the safe use of products requiring a risk minimization program. This article is intended as a guide for the researcher who is charged with the development of survey instruments used in these programs and focuses on the role of cognitive pretesting interviews in successful survey instrument design, data analysis and interpretation.

Healthcare utilization and comorbidity burden among children and young adults in the United States with systemic lupus erythematosus or inflammatory bowel disease.

OBJECTIVE: We sought to assess the feasibility of using a health insurance claims database to estimate the prevalence and health care utilization and costs among children diagnosed with systemic lupus erythematosus (SLE) and inflammatory bowel disease (IBD). STUDY DESIGN: This was a retrospective analysis of the LifeLink insurance claims database for the years 2000-2006. Children (0-15 years) and young adults (16-25 years) with ≥ 2 diagnosis claims for SLE or IBD were selected as the 2 cohorts of interest. For each member of the SLE and IBD cohorts, 2 individuals were randomly selected for a matched comparison group. All the analyses were descriptive in nature, CI for differences between means and 2 proportions for measures including health care utilization, comorbidity burden were based on t tests and 2-group tests of proportions. RESULTS: We identified 278 patients with SLE (prevalence estimate: 7.9 per/100000 population) and 1174 patients with IBD (33.2 per/100000 population). The mean annual total medical costs was substantially higher for the SLE (difference: $22223; 95% CI: $14961-$29485) and IBD (difference: $16238; 95% CI: $14395-$18082) cohorts compared with those of the comparator cohort. We observed higher comorbidity burdens in the SLE and IBD cohorts than we saw in the comparator cohort. CONCLUSIONS: Administrative claims data can be a useful tool for assessing the comparative prevalence and associated resource utilization of rare conditions such as SLE and IBD.

A call for international harmonization in therapeutic risk management.

Therapeutic risk management is required to ensure that the benefits of a particular drug outweigh the risks in general practice. Current risk management strategies and handling of risk management and pharmacovigilance issues differ across borders. Differences in key regulatory decisions on the same product around the world, including the handling of safety issues with cisapride, dofetilide, and isotretinoin, bring into question the robustness of these decisions and the procedures currently in place to manage the risks to the public of products with potentially unfavorable risk-benefit balances. These differences may be partly due to differences in health care systems, regulatory requirements and procedures, and cultures. Greater international harmonization in approaches to risk management potentially would improve safety of medicines around the world by developing a greater uniformity in acquiring and interpreting risk-benefit evidence. The appropriateness and effectiveness of risk management interventions in different regions should be examined, and international strategies should be 'fine-tuned' for each regional health care setting. Recently issued international guidance on risk management and pharmacovigilance may help to improve consistency of decision-making around the world and promote better international communication and collaboration.

Therapeutic risk management interventions: feasibility and effectiveness.

OBJECTIVE: To review the effectiveness and feasibility of risk management strategies implemented for drugs with significant known risks. DATA SOURCES: Published medical literature and regulatory archives, including proceedings of Food and Drug Administration advisory committee meetings. Iterative searches of the medical literature, the Internet, and Web-based government information sources were conducted throughout 2002-2003. Search terms were related to risk management, drug safety, and the names of specific medications known to be subject to risk management programs. STUDY SELECTION: Key studies that illustrated examples of risk management and evaluated risk management programs were selected by the authors. DATA EXTRACTION: Performed manually by the authors. DATA SYNTHESIS: Much of the information regarding the effectiveness of risk management interventions in reducing risk is anecdotal; little information has been published. Given the demand for evidence-based clinical decision making, pharmaceutical manufacturers and the health care community must understand whether these programs are achieving their ultimate goals of reducing risks to patients, while making needed therapies available. This paucity of evidence points to new opportunities for researchers across disciplines to better understand the feasibility and effectiveness of these interventions and the impact of the interventions at the patient, practitioner, and public health levels. Such research needs to be published so that future programs and policy can be informed by these early examples. CONCLUSION: For interventions to be effective in reducing risk, they must effect change in physician prescribing, pharmacist dispensing, and patient adherence. Risk intervention programs that are overly burdensome to physicians, pharmacists, or patients are unlikely to succeed in achieving the desired outcome of reducing individual risk. In addition, risk management programs should be scaleable and implemented in a systematic fashion to accommodate multiple simultaneous programs that can effectively manage the risk, rather than through a piecemeal approach.

The role of scientific evidence of risks and benefits in determining risk management policies for medications.

Recent changes in the regulatory environment have called attention to the need for and potential benefits of greater and more detailed evidence to inform decisions based on the risk-benefit profile of medications. Nevertheless, access to potentially beneficial therapies continues to be impeded by a lack of sufficient information that could help optimize benefits and minimize risks of treatments for patients. Over-reliance on pre-marketing clinical trials and the FDA's spontaneous reporting adverse event system to support regulatory decisions has sustained an information void. Clinical trials are the gold standard for demonstrating efficacy, but they cannot fully predict safety when drugs are used in the real world. Spontaneous reporting can identify new signals, but cannot quantify those signals or place them in appropriate clinical context. In the face of new safety signals, absence of better information on how medications are used and how they perform in the real world setting, regulators are often limited to either continuing drug marketing without significant changes or withdrawing a medication from the market. Experience shows that information collected proactively, to better understand the background risks associated with the underlying disease and to better quantify the product risks, can influence these decisions to include a wider range of options regarding a product's availability, labeling and additional risk management strategies. This article presents several case studies of medications, including those in which insufficient data were available to address important safety signals and decisions were made to withdraw products, as well as those in which epidemiologic data were available to provide reassurance of product safety and allow continued product use, even though some may be marketed with additional risk management programs. More extensive and earlier epidemiologic assessment of risks and benefits of new products will create a new standard of evidence for industry and regulators and is likely to result in more effective and balanced regulatory actions, thereby affording better care for patients.