Social Media Guidelines for Young Plastic Surgeons and Plastic Surgery Training Programs.

SUMMARY: Social media are a powerful tool that creates a unique opportunity for the young plastic surgeon and trainee to share content, brand oneself, educate the public, and develop one's own professional voice early. The majority of all plastic surgery programs and particularly those that are highly ranked have social media opportunities for their residents, yet clear rules to guide implementation of social media programming in residency have remained unspecified. These guidelines and pitfalls can be used to inform a productive and professional entry into plastic surgery social media use for the resident and young plastic surgeon. Details regarding specific platform use to maximize exposure are provided. The core principles of patient safety and privacy, authentic photography, plastic surgery education and advocacy, and professionalism inform these guidelines. Pitfalls include establishment of an online physician-patient relationship, engaging in debate by means of online reviews, providing medical entertainment, and engaging in non-plastic surgery politics. Use of these guidelines will allow the young plastic surgeon and trainee to succeed by means of social media platforms in an ethical and professional manner.

Innovative Recruitment Strategies to Increase Diversity of Participation in Parkinson's Disease Research: The Fox Insight Cohort Experience.

BACKGROUND: Clinical research in Parkinson's disease (PD) faces practical and ethical challenges due to two interrelated problems: participant under-recruitment and lack of diversity. Fox Insight (FI) is a web-based longitudinal study collecting patient-reported outcomes and genetic data worldwide to inform therapeutic studies. FI's online platform provides an opportunity to evaluate online strategies for recruiting large, diverse research cohorts. OBJECTIVE: This project aimed to determine 1) whether FI's digital marketing was associated with increased enrollment overall and from under-represented patient groups, compared to traditional recruitment methods; 2) the clinical and demographic characteristics of samples recruited online, and 3) the cost of this online recruitment. METHOD: FI recruitment during a 6-week baseline period without digital promotion was compared to recruitment during several periods of digital outreach. Separate online recruiting intervals included general online study promotion and unique Facebook and Google ad campaigns targeting under-represented subgroups: early PD, late/advanced PD, and residents of underrepresented/rural geographic areas. RESULTS: Early PD, late PD, and geotargeting campaigns enrolled more individuals in their respective cohorts compared to baseline. All online campaigns also yielded greater total FI enrollment, attracting more participants who were non-White, Hispanic, older, female, and had lower educational attainment and income, and more medical comorbidities. Cost per new participant ranged from $21 (Facebook) to $108 (Google). CONCLUSION: Digital marketing may allow researchers to increase, accelerate, and diversify recruitment for PD clinical studies, by tailoring digital ads to target PD cohort characteristics.

Rogue stem cell clinics.

Cell therapies hold significant promise for the treatment of injured or diseased musculoskeletal tissues. However, despite advances in research, there is growing concern about the increasing number of clinical centres around the world that are making unwarranted claims or are performing risky biological procedures. Such providers have been known to recommend, prescribe, or deliver so called 'stem cell' preparations without sufficient data to support their true content and efficacy. In this annotation, we outline the current environment of stem cell-based treatments and the strategies of marketing directly to consumers. We also outline the difficulties in the regulation of these clinics and make recommendations for best practice and the identification and reporting of illegitimate providers. Cite this article: Bone Joint J 2020;102-B(2):148-154.

The direct-to-consumer market for stem cell-based interventions in Australia: exploring the experiences of patients.

The prevalence of businesses selling autologous stem cell-based interventions to patients in Australia has raised serious concerns about how weaknesses in regulation have enabled the emergence of an industry that engages in aggressive marketing of unproven treatments to patients. Little is known about how patients experience this marketing and their subsequent interactions with practitioners. This paper reports results from 15 semistructured interviews with patients and carers, and also draws upon discussion conducted with patients, carers and family members (22 participants) in a workshop setting. We explore how Australian patients and carers understand and experience these interventions, and how their presumptions about the ethics of medical practice, and the regulatory environment in Australia have conditioned their preparedness to undergo unproven treatments.

Regulación actual de los productos sanitarios: ¿es suficiente? / Current medical device regulation: Is that enough?

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A Primer on Social Media Use by Young Plastic Surgeons.

Similar to the outcry over the ethics of website marketing by physicians in the 1990s, the resistance to plastic surgeons' use of social media has been loud and vehement. Many physicians, although receptive to website marketing, view social media as too radical or unprofessional. Despite the controversy, the value of social media as a communication tool for interacting with and educating patients is supported by studies showing that 65 percent of Americans and 90 percent of young adults use social media. Many plastic surgeons have been early adopters, as reflected by the articles written to help board-certified plastic surgeons use social media in academic medicine and for their practice. However, there is little guidance for young plastic surgeons who wish to use social media for professional purposes. In this study, the authors discuss the ethics and current literature on social media use by young plastic surgeons and make recommendations for how to use social media during training and after residency graduation.

Timely, consistent, transparent assessment of market access evidence: implementing tools based on the HTA Core Model® in a pharmaceutical company.

OBJECTIVES: Evidence requirements and assessment methods access differ between health technology assessment (HTA) agencies. The HTA Core Model® provides a standardized approach to HTA, targeting evidence sharing and collaboration between participating HTA bodies. It is fit for purpose from an industry perspective and was used by pharmaceutical company Roche to develop a framework for internal assessment of evidence required for market access and coverage/reimbursement ("access evidence"). METHODS: Tools were developed to systematically scope, assess, plan, and summarize access evidence generation. The tools were based mainly on the first four HTA Core Model® domains and rolled-out in selected development teams in 2017. Five months after full implementation, the impact of tools was assessed in an internal survey. RESULTS: Systematic access evidence generation started with the Access Evidence Questionnaire, to scope evidence requirements and identify evidence gaps. Findings were summarized in the Access Evidence Metric, which assessed the alignment of available/planned evidence against HTA bodies' requirements and developed scope mitigation strategies. The Access Evidence Plan was then used to plan and document (additional) evidence generation. Once generated, evidence was summarized in the Access Evidence Dossier. A survey of twenty-seven Roche employees involved in evidence generation showed that the tools made discussions around access strategies and evidence more efficient and transparent. CONCLUSIONS: The HTA Core Model® provided a useful framework around which to optimize internal evidence generation and assessment. The benefits of using a standardized HTA approach in industry mirror those expected from implementing the HTA Core Model® in HTA agencies.

The road to market implantable drug delivery systems: a review on US FDA's regulatory framework and quality control requirements.

The scope of Implantable Drug Delivery Systems (IDDSs) comprehends a variety of sterile therapeutic implements placed inside the body to exert a certain therapeutic action for extended duration. They are classified under different categories from pharmaceutical science and regulatory perspectives. The novelty and variety of IDDSs prevent the application of a uniform regulation for all IDDS products; therefore, sponsors face regulatory challenges to register and market their products. This review investigates pharmaceutical science literature and the United States Food and Drug Administration (US FDA) regulatory guidance to find how any IDDS is classified, regulated, and introduced in the market. The regulatory classification of any IDDS, as a 'drug', 'medical device' or a 'combination product', is the cornerstone in determining the regulatory pathway, which decides the quality control requirements preceding the marketing approval. IDDSs are generally recognized as combination products as they consist of two or more regulated components (drugs, medical devices or biological products) combined prior to use to function as a single entity. Although robust and defined US FDA regulatory pathways exist for each component independent of one another, the regulatory pathways for combination products are less formalized.

EU decision-making for marketing authorization of advanced therapy medicinal products: a case study.

A comparative analysis of assessment procedures for authorization of all European Union (EU) applications for advanced therapy medicinal products (ATMPs) shows that negative opinions were associated with a lack of clinical efficacy and identified severe safety risks. Unmet medical need was often considered in positive opinions and outweighed scientific uncertainties. Numerous quality issues illustrate the difficulties in this domain for ATMP development. Altogether, it suggests that setting appropriate standards for ATMP authorization in Europe, similar to elsewhere, is a learning experience. The experimental characteristics of authorized ATMPs urge regulators, industry, and clinical practice to pay accurate attention to post-marketing risk management to limit patient risk. Methodologies for ATMP development and regulatory evaluations need to be continuously evaluated for the field to flourish.

[An objective scoring system to evaluate the credibility of health related websites]. / Rendszer az egészségügyi weboldalak hitelesítésére.

INTRODUCTION AND AIM: The unreliable quality of online health contents poses a serious challenge to the medical profession. Evaluating websites on the basis of their credibility increases the chance for readers to access professional content of better quality. Hungary still lags behind in taking practical steps to improve the quality and reliability of online patient education. METHOD: EgészségKommandó (HealthCommando) is a new Hungarian objective scoring system established to evaluate the credibility of health related websites. It uses four types of indicators: transparency, content, recommendations, references. RESULTS: We evaluated 122 websites with EgészségKommandó. Out of this, 22.1% qualified as credible. The same assessment using JAMA benchmarks yielded only one credible website (0.8%). The most frequent deficiencies were the absence of reference to source, the omission of the quote that "the website information does not replace the doctor-patient discussion", and the identity of the author. In 45.9% of the cases, however, the content was written by medical professionals with contact information. CONCLUSION: By applying different types of credibility and quality indicators in a scoring system, EgészségKommandó can efficiently assess the websites on health-awareness. In cases where the recognized indicators are absent multiple times from a website, it will not pass the credibility test. Thus, EgészégKommandó can act as a filter. At the same time, EgészségKommandó is also capable of assessing webpages of different sorts systemically, and can recommend a proportionately large amount of reliable Hungarian medical web resources to those interested. Orv Hetil. 2018; 159(13): 511-519.

Price adjustment for traditional Chinese medicine procedures: Based on a standardized value parity model.

Traditional Chinese medicine (TCM) is an important part of China's medical system. Due to the prolonged low price of TCM procedures and the lack of an effective mechanism for dynamic price adjustment, the development of TCM has markedly lagged behind Western medicine. The World Health Organization (WHO) has emphasized the need to enhance the development of alternative and traditional medicine when creating national health care systems. The establishment of scientific and appropriate mechanisms to adjust the price of medical procedures in TCM is crucial to promoting the development of TCM. This study has examined incorporating value indicators and data on basic manpower expended, time spent, technical difficulty, and the degree of risk in the latest standards for the price of medical procedures in China, and this study also offers a price adjustment model with the relative price ratio as a key index. This study examined 144 TCM procedures and found that prices of TCM procedures were mainly based on the value of medical care provided; on average, medical care provided accounted for 89% of the price. Current price levels were generally low and the current price accounted for 56% of the standardized value of a procedure, on average. Current price levels accounted for a markedly lower standardized value of acupuncture, moxibustion, special treatment with TCM, and comprehensive TCM procedures. This study selected a total of 79 procedures and adjusted them by priority. The relationship between the price of TCM procedures and the suggested price was significantly optimized (p < 0.01). This study suggests that adjustment of the price of medical procedures based on a standardized value parity model is a scientific and suitable method of price adjustment that can serve as a reference for other provinces and municipalities in China and other countries and regions that mainly have fee-for-service (FFS) medical care.

Societal challenges of precision medicine: Bringing order to chaos.

The increasing number of drugs targeting specific proteins implicated in tumourigenesis and the commercial promotion of relatively affordable genome-wide analyses has led to an increasing expectation among patients with cancer that they can now receive effective personalised treatment based on the often complex genomic signature of their tumour. For such approaches to work in routine practice, the development of correspondingly complex biomarker assays through an appropriate and rigorous regulatory framework will be required. It is becoming increasingly evident that a re-engineering of clinical research is necessary so that regulatory considerations and procedures facilitate the efficient translation of these required biomarker assays from the discovery setting through to clinical application. This article discusses the practical requirements and challenges of developing such new precision medicine strategies, based on leveraging complex genomic profiles, as discussed at the Innovation and Biomarkers in Cancer Drug Development meeting (8th-9th September 2016, Brussels, Belgium).

Characterizing the interaction between physicians, pharmacists and pharmaceutical representatives in a middle-income country: A qualitative study.

BACKGROUND: Studies around the world have shown that interactions between pharmaceutical companies, pharmacists and physicians have a great influence on prescribing and drug dispensing practices. In middle-income countries, the nature and extent of these interactions have not been well researched. Our objectives were to qualitatively explore the nature of the interactions between pharmaceutical companies, physicians and pharmacists, their impact on drug prescription and dispensing practices in Lebanon. METHODS AND FINDINGS: We used grounded theory approach as well as the known sponsor, purposive, and snowballing sampling strategies to identify interviewees from the three respective groups: physicians, pharmacists, and pharmaceutical representatives. We conducted semi-structured and analyzed transcripts thematically. This study encompassed 6 pharmaceutical representatives, 13 physicians and 13 pharmacists. The following themes emerged: purpose and driver for the interactions, nature of the interactions, incentives, impact on prescription practices, ethical considerations, and suggestions for managing the interactions. The main purposes for the interaction were educational, promotional, and monitoring prescription practices and dispensing, while the main drivers for these interactions were market potential and neighborhood socio-economic status. Physicians, pharmacists and pharmaceutical representatives who engage in these interactions benefit from a variety of incentives, some of which were characterized as unethical. It appears that pharmaceutical companies give prominence to selected physicians within their communities. Although members of the three interviewed groups refer to some of the interactions as being problematic, they described a culture of acceptance of gift giving. We developed a framework that depicts the prevailing politico-cultural environment, the interactions between the three professional groups, and their impact on drug prescription. Underreporting is the main limitation of this study. CONCLUSION: Interactions between physicians, pharmacists and pharmaceutical representatives are frequent. Although these interactions can be beneficial, they still have a substantial effect on drug prescription and dispensing practices. Hence, the need for new policies that regulate these interactions and penalize any misconduct.