Differences in Evidentiary Requirements Between European Medicines Agency and European Health Technology Assessment of Oncology Drugs—Can Alignment Be Enhanced?

ObjectivesNational health technology assessments (HTAs) across Europe show differences in evidentiary requirements from assessments by the European Medicines Agency (EMA), affecting time to patient access for drugs after marketing authorization. This article analyzes the differences between EMA and HTA bodies’ evidentiary requirements for oncology drugs and provides recommendations on potential further alignment to minimize and optimally manage the remaining differences.MethodsInterviews were performed with representatives and drug assessment experts from EMA and HTA bodies to identify evidentiary requirements for several subdomains and collect recommendations for potentially more efficiently addressing differences. A comparative analysis of acceptability of the evidence by EMA and the HTA bodies and for potential further alignment between both authorities was conducted.ResultsAcceptability of available evidence was higher for EMA than HTA bodies. HTA bodies and EMA were aligned on evidentiary requirements in most cases. The subdomains showing notable differences concerned the acceptance of limitation of the target population and extrapolation of target populations, progression-free survival and (other) surrogate endpoints as outcomes, cross-over designs, short trial duration, and clinical relevance of the effect size. Recommendations for reducing or optimally managing differences included joint early dialogues, joint relative effectiveness assessments, and the use of managed entry agreements.ConclusionsDifferences between assessments of EMA and HTA bodies were identified in important areas of evidentiary requirements. Increased alignment between EMA and HTA bodies is suggested and recommendations for realization are discussed.     

Collaborating toward equity in Pennsylvania: The Age-Friendly Care,PA project

Objective

To collaboratively implement the age-friendly health systems framework, known as the 4Ms: What Matters, Medication, Mentation, and Mobility, at The Primary Health Network (PHN), a federally qualified health center.

Data Sources

Data were collected from PHN electronic medical records (EMRs) for individuals over age 65 from December 30, 2019 to December 24, 2021 and from Project ECHO© attendance and evaluation surveys.

Study Design

The telementoring educational program, Project ECHO©, was used to engage PHN health care professionals working in rural areas of Pennsylvania to incorporate the 4Ms into their practice starting with the annual wellness visit (AWV). Project ECHO© was launched at three primary care sites. After 18 months, it was then disseminated to an additional 18 sites creating pilot and comparison groups. Outcomes included codesigned patient process metrics using EMR data and project ECHO© participant data.

Data Collection Methods

EMR data were generated by system reports created by PHN's quality assurance program manager. Project ECHO© data were collected and managed using REDCap electronic data capture tools. Outcomes were aggregated, analyzed for trends over time, and compared between groups.

Principal Findings

All nine process outcomes increased from baseline to follow-up at the three initial sites, ranging from 4% to 43% g. At year two, the three initial sites had higher rates on AWVs (pilot 24%, comparison 12%; p < 0.0001), Advance Care Planning (New on file, pilot 8%, comparison 2%; Discussed with patient, pilot 18%, comparison 13%; Patient declined, pilot 0%, comparison 0%; p = 0.0001), Dementia Screening (pilot 24%, comparison 12%; p < 0.0001), Fall Risk Management (pilot 43%, comparison 10%; p < 0.0001), and Mobility Goal (pilot 19%, comparison 9%; p < 0.0001); and lower rates on High-Risk Medication Elimination (pilot 54%, comparison, 63%, p < 0.02).

Conclusions

Access to high-quality geriatric care for rural older adults can be improved by increasing health care professionals' knowledge of the 4Ms, beginning with its incorporation into the AWV.     

Online Patient Information for Hysterectomies: A Systematic Environmental Scan of Quality and Readability

ObjectiveHysterectomy is a common gynaecological procedure, and therefore online information is highly valuable to patients. Our objective was to evaluate the quality, readability, and comprehensiveness of online patient information on hysterectomy.MethodsThe first 25 patient-directed websites on hysterectomy, identified using 5 online search engines (Google, Yahoo, AOL, Bing, Ask.com) as well as clinical professional societies, were assessed using validated tools for quality (DISCERN, JAMA benchmark), readability (Flesch-Kincaid Grade Level [FKGL], Gunning Fog, Simple Measure of Gobbledygook [SMOG], Flesch Reading Ease Score [FRES]), and completeness of information.ResultsWe identified 50 websites for inclusion. Overall, websites were of good quality (median DISCERN score 53/80 [interquartile range {IQR} 47–61]; median JAMA score 3/4 [IQR 1–4]). Most websites described surgical risks (39, 78%), benefits (45, 90%), and types of hysterectomy (48, 96%). Content readability corresponded to grade 11 using FKGL (median 11.1 [IQR 10.2–13.0]) and SMOG (median 10.9 [IQR 10.2–12.4]), or 15 years education using Gunning Fog (median 14.7 [IQR 13.8–16.4]). Websites were assessed as difficult to read using FRES (median 45.6/100 [IQR 37.9–50.9]). No differences were observed in readability scores when we compared websites from clinical professional societies, government, health care, or academic organizations with other websites (P > 0.05).ConclusionOnline patient information on hysterectomy is of good quality and comprehensive. However, the content is above the American Medical Association’s recommended grade 6 reading level. Website authors should consider readability to make their content more accessible to patients.     

A Lifestyle Intervention Program to Improve Knowledge and Health Behaviors in Women

ObjectiveTo improve health knowledge, facilitate healthy behaviors, and provide social support for a high-risk population of women by implementing a culturally tailored, gender-specific lifestyle intervention program.DesignEvidence-based practice project.Setting/Local ProblemA Chicago neighborhood in Cook County, Illinois, where there are increased rates of diabetes, heart disease, cancer, stroke, hypertension, obesity, preterm birth, and violent crime.ParticipantsFemale residents of the community, ages 19 to 45 years; 12 participants registered for the program, and 11 participants completed the entire 2-month program.Interventions/MeasurementsThe BE WISE Lifestyle Intervention, a culturally tailored, gender-specific behavior change curriculum, was used for this project. An interprofessional team was used to enhance participant experience, and neighborhood collaborations were established to create sustainability of efforts. Pre- and postintervention measures of diet, physical activity, social support, and knowledge acquisition were used to evaluate outcomes.ResultsImprovement was noted for knowledge in most of the content areas, as well as for dietary and physical activity behaviors. All participants rated the program highly and responded positively to the social support experienced in the group.ConclusionCulturally tailored lifestyle interventions can be effective in improving knowledge and encouraging behavior change, especially when delivered in group settings to enhance social support. Community-level collaborations enhance interventions by providing local support and resources for participants. Because behavior change takes time, follow-up at the 6-month and 1-year intervals is recommended to determine longer-term outcomes.     

童年期不良经历对个体健康影响的研究进展

童年期不良经历(ACEs)作为一项全球性的严峻公共卫生挑战,其对全生命周期的健康影响不容小觑。因此本文从心理健康、生理健康、性传播疾病及危险性行为、健康危险行为4个方面对ACEs的健康影响进行综述,为ACEs及其可能健康结局提供参考。     

Perceived neighborhood social cohesion and the 10-year risk of cardiovascular disease in low- and middle-income countries: The World Health Organization Study on Global Aging and Adult Health

Low- and middle-income countries (LMICs) bear the greatest burden of cardiovascular disease (CVD) worldwide. Emerging evidence, mostly from industrialized countries, suggest that neighborhood characteristics influence cardiovascular health. This study presents results from 27,797 participants living in six LMICs on the association of perceived neighborhood social cohesion, the degree of connectedness among neighbors, with 10-year risk of CVD. We observed that greater perceived neighborhood social cohesion was associated with lower odds of high (>20%) 10-year CVD risk (OR = 0.67, 95%CI: 0.53–0.86). These novel findings, suggest that interventions to enhance social cohesion may have beneficial effects on cardiovascular health in LMICs.     

Insufficient knowledge and inapproriate physiotherapy management of Relative Energy Deficiency in Sport (RED-S) in lightweight rowers

ObjectiveTo investigate the knowledge and management of Relative Energy Deficiency in Sport (RED-S), from the perspective of lightweight rowers and physiotherapists.DesignSemi-structured individual qualitative interviews.MethodsPhysiotherapists who had worked with lightweight rowers, and current and former lightweight rowers (who had experienced at least one symptom of RED-S), undertook audio-recorded semi-structured telephone interviews. An inductive thematic analysis was performed, facilitated by NVivo software.ResultsTwelve physiotherapists (n = 6 females, 1–20 years of experience managing lightweight rowers) and twelve lightweight rowers (n = 8 females, 1–8 years lightweight rowing experience, intermediate to elite/international level) were interviewed. Five key themes were identified: insufficient knowledge of RED-S, inadequate RED-S education, inappropriate management of RED-S, referral to other health professionals, prioritising performance over health. Participants provided suggestions for improving knowledge and management of RED-S in lightweight rowers, including formal physiotherapy education and training, and targeted education for athletes and coaches.ConclusionsThere was a significant lack of awareness of RED-S amongst physiotherapists and lightweight rowers. Most physiotherapists were not confident discussing or managing RED-S in athletes, and lightweight rowers were dissatisfied with the management they received. Improving RED-S education for physiotherapists and athletes may have important health implications for lightweight rowers.     

Implementation of a Semistructured Clinical Event Documentation Tool for Acute Adverse Contrast Reactions

PurposeTo improve the efficiency and accuracy of clinicians documenting acute clinical events related to contrast agent administration using a web browser–based semistructured documentation support tool.MethodsA new tool called Contrast Incident Support and Reporting (CISaR) was developed to enable radiologists responding to contrast reactions to document inciting contrast class, type of event, severity of contrast reaction, and recommendation for future contrast use. Retrospective analysis was conducted of all CT and MRI examinations performed between February 2018 and December 2019 across our hospital system with associated contrast reaction documentation. Time periods were defined as before tool deployment, early adoption, and steady-state deployment. The primary outcome measure was the presence of event documentation by a radiologist. The secondary outcome measure was completeness of the documentation parameters.ResultsA total of 431 CT and MRI studies with reactions were included in the study, and 50% of studies had radiologist documentation during the pre-CISaR period. This increased to 66% during the early adoption period and 89% in the post-CISaR period. It took approximately 9 months from the introduction of CISaR to reach full adoption and become the main method for adverse contrast reaction documentation. The percentage of radiologist documentation that detailed provoking contrast agent class, severity of reaction, reaction type, and future contrast agent recommendation all significantly increased (P < .0001), with greater than 95% inclusion of each element.ConclusionThe implementation of a semistructured electronic application for adverse contrast reaction reporting significantly increased radiologist documentation rate and completeness of the documentation.