The Model of “Informed Refusal” for Vaccination: How to Fight against Anti-Vaccinationist Misinformation without Disregarding the Principle of Self-Determination

Vaccines are arguably a public health success story as well as an incredibly cost-effective medical resource. Despite this, worldwide concerns about their safety are growing, with the risk of increased morbidity and mortality in vaccine-preventable diseases because of vaccine refusal. The global political trend in developed countries is to increasingly reduce mandates and the compulsory nature of vaccination programs. This is due to strong opposition from anti-vaccination movements and groups. While these have existed since the beginnings of vaccinology, they have recently gained a strong foothold through massive exploitation of the media and especially the internet. This has led to widespread misinformation and greater difficulty for governments and health institutions in dealing with parents’ concerns and misconceptions. Common strategies in order to maintain a high degree of public acceptance of vaccines include the enhancement of adverse effect reporting systems, the enrichment of scientific literature, and the dissemination of targeted information to parents and health care providers. Vaccine risk perception, in fact, largely exceeds the evidence and is linked to well-known general population cognitive bias, which must be recognized and corrected. Although there is no doubt about the convenience of universal vaccination, a lively international debate is underway with regard to the legitimacy of mandatory vaccination programs. Most scientists agree that the individual’s right to self-determination should be preserved. The only way to simultaneously protect the right to health is to introduce an informed refusal model, which aims to guarantee the highest coverage rates for vaccination.

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Knowledge Based Commissioning: Can a National Clinical Effectiveness Policy Be Compatible with Seeking Local Professional Advice?

Journal of Health Services Research & Policy ◽

10.1177/135581969600100106 ◽

1996 ◽

Vol 1 (1) ◽

pp. 28-34 ◽

Cited By ~ 5

Author(s):

Peter Littlejohns ◽

Carol Dumelow ◽

Sian Griffiths

Keyword(s):

Health Care ◽

Health Care Providers ◽

Clinical Effectiveness ◽

Cost Effective ◽

Care Providers ◽

Professional Advice ◽

Knowledge Based ◽

Artery Disease ◽

Health Care Purchasing ◽

The Right

Objectives: To help develop a means, based on the views of purchasers and providers of health care, of incorporating national research on clinical effectiveness into local professional advisory mechanisms in order to inform health care purchasing and contracting. Methods: Three geographically based multidisciplinary workshops attended by National Health Service (NHS) staff drawn from the principal purchaser and provider groups in one English region were organized around the discussion of three health care purchasing case studies: Coronary artery disease, diabetes and management of clinical depression in general practice. The proceedings were transcribed and analyzed using content analysis methods. Results: 95 people took part. There were major differences between the purchasers' and health care providers' views on the right balance between local and national information and advisory sources for purchasing. In general, providers wanted the provision of advice to purchasers to be local, in which their opinion was sought, either individually or collectively, acted on and the results fed back to them. In contrast, health authority purchasers considered that local professionals were only one source of professional advice, albeit an important one, to be utilized in coming to decisions. General practitioner fundholders as purchasers, however, preferred to rely on their own experiences and contacts with local providers in making purchasing decisions. Conclusions: Professional specialist advisory groups are necessary to inform the purchasing of health care, but should extend beyond advising on the placement of individual contracts. Involving health care providers in all short-term contracting is unlikely to be cost-effective given the time commitment required. The emphasis at purchaser/provider meetings should be on education: Providing an opportunity for purchasers and providers to develop closer relationships to discuss political imperatives and financial constraints; increasing communication and understanding of providers' and purchasers' roles; and providing an environment for professionals and purchasers to share their views on purchasing. As currently presented, elements of the national policies in the NHS advocating the use of both national evidence on clinical effectiveness and local professional advice are contradictory and should be clarified.

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Informed consent and informed intervention: SARS-CoV-2 vaccinations not just call for disclosure of newly emerging safety data but also for hypothesis generation and testing

European Journal of Medical Research ◽

10.1186/s40001-021-00558-y ◽

2021 ◽

Vol 26 (1) ◽

Author(s):

Johannes C. Fischer ◽

Albrecht G. Schmidt ◽

Edwin Bölke ◽

Verena Keitel ◽

Torsten Feldt ◽

...

Keyword(s):

Health Care ◽

Health Care Providers ◽

Viral Infections ◽

Safety Data ◽

Hypothesis Generation ◽

Care Providers ◽

Vaccination Programs ◽

Major Threat ◽

The World ◽

Population Scale

Abstract Background COVID-19 infection is a major threat to patients and health care providers around the world. One solution is the vaccination against SARS-CoV-2. Methods We performed a comprehensive query of the latest publications on the prevention of viral infections including the recent vaccination program and its side effects. Results The situation is evolving rapidly and there is no reasonable alternative to population-scale vaccination programs as currently enrolled. Conclusion Therefore, regulatory authorities should consider supplementing their conventional mandate of post-approval pharmacovigilance, which is based on the collection, assessment, and regulatory response to emerging safety findings.

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Multimorbidity, Consumer-Directed Care, and Drug-Related Harm

The Senior Care Pharmacist ◽

10.4140/tcp.n.2021.126 ◽

2021 ◽

Vol 36 (3) ◽

pp. 125-126

Author(s):

Chris Alderman

Keyword(s):

Health Care Providers ◽

Developed Countries ◽

Care Practice ◽

Care Providers ◽

Term Care ◽

Societal Challenges ◽

Psychiatric Conditions ◽

New Treatments ◽

Related Harm

People from developed countries around the world now routinely live into their 80s and beyond, and this is associated with a range of medical and societal challenges that must be addressed. It is relatively rare to encounter older people who are not affected by one or more chronic diseases, including conditions such as osteoarthritis, gastroesophageal reflux disease (GERD), hypertension, and depression. The concurrence of a number of medical and/or psychiatric conditions in the same patient has come to be referred to as multimorbidity, and it is a particularly familiar phenomenon observed by health care providers in settings such as the Emergency Department (ED), primary care practice, and long-term care facilities. Given that life expectancy continues to increase, and that there is considerable further investment in research for the development of new treatments, which will achieve adoption and be promoted to consumers, it is clear that multimorbidity is likely to be a driver for problems arising from medications that are vigorously promoted to consumers.

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Preclinical and clinical validation of a novel injected molded swab for molecular assay detection of SARS-CoV-2 virus

10.1101/2021.10.19.21265200 ◽

2021 ◽

Author(s):

Chiara Elia Ghezzi ◽

Devon R Hartigan ◽

Justin Hardick ◽

Rebecca Gore ◽

Miryam Adelfio ◽

...

Keyword(s):

Health Care Providers ◽

Medical Devices ◽

Clinical Studies ◽

Nasal Swab ◽

Cost Effective ◽

Slight Reduction ◽

Care Providers ◽

Significant Difference ◽

Injection Molded

During the COVID-19 public health emergency, many actions have been undertaken to help ensure that patients and health care providers had timely and continued access to high-quality medical devices to respond effectively. The development and validation of new testing supplies and equipment, including collection swab, help expand the availability and capability for various diagnostic, therapeutic, and protective medical devices in high demand during the COVID-19 emergency. Here, we report the validation of a new injection-molded anterior nasal swab, ClearTip™, that was experimentally validated in a laboratory setting as well as in independent clinical studies in comparison to gold standard flocked swabs. We have also developed an in vitro anterior nasal tissue model, that offers an efficient and clinically relevant validation tool to replicate with high fidelity the clinical swabbing workflow, while being accessible, safe, reproducible, time and cost effective. ClearTi™ displayed a greater efficiency of release of inactivated virus in the benchtop model, confirmed by greater ability to report positive samples in a clinical study in comparison to flocked swabs. We also quantified in multi-center pre-clinical and clinical studies the detection of biological materials, as proxy for viral material, that showed a statistically significant difference in one study and a slight reduction in performance in comparison to flocked swabs. Taken together these results underscore the compelling benefits of non-absorbent injected molded anterior nasal swab for COVID-19 detection, comparable to standard flocked swabs. Injection-molded swabs, as ClearTip™, could have the potential to support future swab shortage, due to its manufacturing advantages, while offering benefits in comparison to highly absorbent swabs in terms comfort, limited volume collection, and potential multiple usage.

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Preclinical Validation of a Novel Injection-Molded Swab for the Molecular Assay Detection of SARS-CoV-2

Diagnostics ◽

10.3390/diagnostics12010206 ◽

2022 ◽

Vol 12 (1) ◽

pp. 206

Author(s):

Chiara E. Ghezzi ◽

Devon R. Hartigan ◽

Justin P. Hardick ◽

Rebecca Gore ◽

Miryam Adelfio ◽

...

Keyword(s):

Health Care Providers ◽

Medical Devices ◽

Clinical Studies ◽

Cost Effective ◽

Care Providers ◽

Nasal Tissue ◽

Significant Difference ◽

Injection Molded ◽

Development And Validation

During the COVID-19 public health emergency, many actions have been undertaken to help ensure that patients and health care providers have timely and continued access to high-quality medical devices to respond effectively. The development and validation of new testing supplies and equipment, including collection swabs, has helped to expand the availability and capability for various diagnostic, therapeutic, and protective medical devices in high demand during the COVID-19 emergency. Here, we report the initial validation of a new injection-molded anterior nasal swab, ClearTip™, that was experimentally validated in a laboratory setting as well as in independent clinical studies in comparison to gold standard flocked swabs. We have also developed an in vitro anterior nasal tissue model which offers a novel, efficient, and clinically relevant validation tool to replicate the clinical swabbing workflow with high fidelity, while being accessible, safe, reproducible, and time- and cost-effective. ClearTip™ displayed greater inactivated virus release in the benchtop model, confirmed by its greater ability to report positive samples in a small clinical study in comparison to flocked swabs. We also quantified the detection of biological materials, as a proxy for viral material, in multi-center pre-clinical and clinical studies which showed a statistically significant difference in one study and a reduction in performance in comparison to flocked swabs. Taken together, these results emphasize the compelling benefits of non-absorbent injection-molded anterior nasal swabs for COVID-19 detection, comparable to standard flocked swabs. Injection-molded swabs, as ClearTip™, could have the potential to support future swab shortages, due to its manufacturing advantages, while offering benefits in comparison to highly absorbent swabs in terms of comfort, limited volume collection, and potential multiple usage.

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Has Metal-On-Metal Resurfacing Been a Cost-Effective Intervention for Health Care Providers?—A Registry Based Study

PLoS ONE ◽

10.1371/journal.pone.0165021 ◽

2016 ◽

Vol 11 (11) ◽

pp. e0165021

Author(s):

Ruth Pulikottil-Jacob ◽

Martin Connock ◽

Ngianga-Bakwin Kandala ◽

Hema Mistry ◽

Amy Grove ◽

...

Keyword(s):

Health Care ◽

Health Care Providers ◽

Cost Effective ◽

Effective Intervention ◽

Care Providers ◽

Metal On Metal

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Challenges and approaches to implementing master/basket trials in oncology

Blood Advances ◽

10.1182/bloodadvances.2019031229 ◽

2019 ◽

Vol 3 (14) ◽

pp. 2237-2243 ◽

Cited By ~ 2

Author(s):

Amy Burd ◽

Richard L. Schilsky ◽

John C. Byrd ◽

Ross L. Levine ◽

Vassiliki A. Papadimitrakopoulou ◽

...

Keyword(s):

Health Care Providers ◽

Therapeutic Option ◽

Clinical Trial Design ◽

Care Providers ◽

Rare Mutation ◽

Medical Institutions ◽

Number Of Patients ◽

The Right ◽

Tumor Types ◽

Basket Trials

Abstract The appetite for cutting-edge cancer research, across medical institutions, scientific researchers, and health care providers, is increasing based on the promise of true breakthroughs and cures with new therapeutics available for investigation. At the same time, the barriers for advancing clinical research are impacting how quickly drug development efforts are conducted. For example, we know now that under a microscope, patients with the same type of cancer and histology might look the same; however, the reality is that most cancers are driven by genomic, transcriptional, and epigenetic changes that make each patient unique. Additionally, the immunologic reaction to different tumor types is distinct among patients. The challenge for researchers developing new therapies today is vastly different than it was in the era of cytotoxics. Today, we must identify a sufficient number of patients harboring a rare mutation or other characteristic and match this to the right therapeutic option. This summary provides a guide to help inform the scientific cancer community about the benefits and challenges of conducting umbrella or basket trials (master trials), and to create a roadmap to help make this new and evolving form of clinical trial design as effective as possible.

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Improving Access to Cancer Treatments: The Role of Biosimilars

Journal of Global Oncology ◽

10.1200/jgo.2016.008607 ◽

2017 ◽

Vol 3 (5) ◽

pp. 596-610 ◽

Cited By ~ 16

Author(s):

Rakesh Chopra ◽

Gilberto Lopes

Keyword(s):

Health Care ◽

Cancer Treatment ◽

Health Care Providers ◽

Cost Effective ◽

Cancer Therapies ◽

Care Providers ◽

Cancer Treatments ◽

Reference Drug ◽

Effective Use ◽

The Cost

Biologics play a key role in cancer treatment and are principal components of many therapeutic regimens. However, they require complex manufacturing processes, resulting in high cost and occasional shortages in supply. The cost of biologics limits accessibility of cancer treatment for many patients. Effective and affordable cancer therapies are needed globally, more so in developing countries, where health care resources can be limited. Biosimilars, which have biologic activity comparable to their corresponding reference drugs and are often more cost effective, have the potential to enhance treatment accessibility for patients and provide alternatives for decision makers (ie, prescribers, regulators, payers, policymakers, and drug developers). Impending patent expirations of several oncology biologics have opened up a vista for the development of corresponding biosimilars. Several countries have implemented abbreviated pathways for approval of biosimilars; however, challenges to their effective use persist. Some of these include designing appropriate clinical trials for assessing biosimilarity, extrapolation of indications, immunogenicity, interchangeability with the reference drug, lack of awareness and possibly acceptance among health care providers, and potential political barriers. In this review, we discuss the potential role and impact of biosimilars in oncology and the challenges related to their adoption and use. We also review the safety and efficacy of some of the widely used biosimilars in oncology and other therapeutic areas (eg, bevacizumab, darbepoetin, filgrastim, rituximab, and trastuzumab).

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Clinical ethics and law in health care system

INTERNATIONAL JOURNAL OF ETHICS TRAUMA & VICTIMOLOGY ◽

10.18099/ijetv.v3i1.8793 ◽

2017 ◽

Vol 3 (1) ◽

Author(s):

Abhinav Gorea

Keyword(s):

Health Care ◽

Health Care System ◽

Health Care Providers ◽

Clinical Ethics ◽

Ethical Dilemmas ◽

Care Providers ◽

Complete Cure ◽

Law And Ethics ◽

Good For ◽

The Right

Different situations arise while treating the patients when there are ethical dilemmas to give one or other type of treatment or not to do anything. Sometimes doctors and nurses consider that what is good for the patient must be done because the patient does not understand the situation and consequences. This may lead to complete cure and patient usually goes back to home happily but sometimes a complication may occur and the patient may sue the health care providers. When such situations are analyzed then principles of ethics and law are considered to see if any of these have been violated or not to reach the conclusion. In this study principles of law and ethics of treatment have been discussed to reach the right conclusion; which will be helpful in situations where there are ethical dilemmas during the treatment.

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User-driven comments on a Facebook advertisement recruiting Canadian parents in a study on immunization: Content Analysis (Preprint)

10.2196/preprints.10090 ◽

2018 ◽

Cited By ~ 2

Author(s):

Jordan Tustin ◽

Natasha Sarah Crowcroft ◽

Dionne Gesink ◽

Ian Johnson ◽

Jennifer Keelan ◽

...

Keyword(s):

Content Analysis ◽

Continuous Monitoring ◽

Developed Countries ◽

Health Interventions ◽

Knowledge Level ◽

Negative Experiences ◽

Vaccine Preventable Diseases ◽

Health Authorities ◽

Social Media Platforms ◽

Coverage Rates

BACKGROUND More people are searching for immunization information online and potentially being exposed to misinformation and anti-vaccine sentiment via content and discussions on social media platforms. As vaccination coverage rates remain sub-optimal in several developed countries, and outbreaks of vaccine preventable diseases [VPDs] become more prevalent, it is important that we build on previous research by analyzing themes in online vaccination discussions, including those that individuals may see without actively searching for information on immunization. OBJECTIVE The study aimed to explore the sentiments and themes behind an unsolicited debate on immunization in order to better inform public health interventions countering anti-vaccine sentiment. METHODS We analyzed and quantified 117 user-driven open-ended comments on immunization posted in the ‘Comments’ section of a Facebook advertisement that targeted Canadian parents for recruitment into a larger study on immunization. Two raters coded all comments using content analysis. RESULTS Out of 117 comments, 85 were unique commentators with the majority being female (76.5%, [103/117]). Most of the immunization comments were positive (43.6%, [51/117]), followed by negative (35.0%, [41/117]), ambiguous (17.1%, [20/117]), and hesitant (4.3%, [5/117]). Inaccurate knowledge (20.8%, [27/130]) and misperceptions of risk (18%, [23/130]) were most prevalent in the 130 non-positive comments. Other claims included distrust of pharmaceutical/government (13.8%, [18/130]), distrust of the health care system/providers (11.5%, [15/130]) and past negative experiences with vaccination or beliefs (7.7% [10/130]), and attitudes about health and prevention (7.7% [10/130]). Almost 40% (29/74) of the positive comments communicated the risks of not vaccinating, followed by judgments on the knowledge level of non-vaccinators (18%, [13/74]). Ten positive comments (14%, [10/74]) specifically refuted the link between autism and immunization. CONCLUSIONS The large number of unsolicited user-driven comments on a platform not intended for discussion nor providing any information on immunization, illustrates the strong sentiments associated with immunization, and the arbitrariness of the online platforms used for immunization debates. Health authorities should be more pro-active in refuting misinformation and misperceptions currently propagating uncontested online. Online debates and communications on immunization need to be identified by continuous monitoring in order for health authorities to understand the current themes and trends, and to engage in the discussion.

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