scholarly journals Easing of Regulatory Barriers to Telemedicine Abortion in Response to COVID-19

2021 ◽  
Vol 2 ◽  
Author(s):  
Patty Skuster ◽  
Jina Dhillon ◽  
Jessica Li

For many people seeking abortion during the continuing COVID-19 pandemic, telemedicine abortion is the safest and most acceptable method, posing lower risk of exposure to the virus. In addition, by reducing in-person visits with health care providers, increased use of telemedicine for abortion can reduce pressure on overburdened health systems. Given the benefits of telemedicine during the pandemic, government agencies in several countries took measures to temporarily allow telemedicine abortion. We conducted key-word English-language searches to identify examples of government action to remove regulatory barriers to the practice of telemedicine abortion in response to the pandemic. We found instances of government agencies in eight countries taking steps to ease regulatory barriers to telemedicine abortion. Telemedicine abortion is safe, cost-effective, and may be the preferred method of abortion during acute periods of COVID-19 transmission, as well as after the pandemic has abated. As one step to expanding access to abortion with medicine where abortion is legal, health agencies and other regulatory bodies can take steps to remove barriers specific to telemedicine abortion.

2021 ◽  
Author(s):  
Chiara Elia Ghezzi ◽  
Devon R Hartigan ◽  
Justin Hardick ◽  
Rebecca Gore ◽  
Miryam Adelfio ◽  
...  

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.


Diagnostics ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. 206
Author(s):  
Chiara E. Ghezzi ◽  
Devon R. Hartigan ◽  
Justin P. Hardick ◽  
Rebecca Gore ◽  
Miryam Adelfio ◽  
...  

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.


PLoS ONE ◽  
2016 ◽  
Vol 11 (11) ◽  
pp. e0165021
Author(s):  
Ruth Pulikottil-Jacob ◽  
Martin Connock ◽  
Ngianga-Bakwin Kandala ◽  
Hema Mistry ◽  
Amy Grove ◽  
...  

1996 ◽  
Vol 1 (1) ◽  
pp. 28-34 ◽  
Author(s):  
Peter Littlejohns ◽  
Carol Dumelow ◽  
Sian Griffiths

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.


2017 ◽  
Vol 3 (5) ◽  
pp. 596-610 ◽  
Author(s):  
Rakesh Chopra ◽  
Gilberto Lopes

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).


2021 ◽  
Vol 8 ◽  
Author(s):  
Francesco Carubbi ◽  
Philipp Bosch ◽  
Pedro M. Machado ◽  
Carlo Alberto Scirè ◽  
Alessia Alunno ◽  
...  

Objectives: To investigate opinion and routine practice of specialists from different disciplines on imaging techniques for interventional procedures related to rheumatic and musculoskeletal diseases (RMDs).Methods: An English-language questionnaire was developed by an international working group and distributed to health care providers of various disciplines involved in the care of people with RMDs via an online survey tool (SoSci Survey®) from December 2019 to May 2020.Results: A total of 1,105 respondents from 56 countries completed the survey, over 60% of participants were rheumatologists. The majority of respondents (88%) performed interventional procedures in RMDs patients and 90% of them used imaging guidance. Ultrasonography was the most frequently used technique, particularly among rheumatologists. X-ray and computed tomography were mainly used by radiologists. A discrepancy emerged between the importance assigned to certain items such as the availability of a second operator and their actual implementation in clinical practice. Local barriers, lack of resources and facilities were mentioned as the most relevant obstacles in this regard. Lack of training on imaging and/or imaging guided procedures did not emerge as a barrier to perform such interventions; in fact, 19% of respondents performing the procedures indicated not to have received adequate training in this field.Conclusions: This is the first multinational multidisciplinary survey exploring in detail the opinions and practice on imaging guidance for interventional procedures in RMDs. A harmonization of protocols based on international guidelines, along with adequate training programmes and interventions on barriers at national/local levels are the main unmet needs requiring attention.


2021 ◽  
Vol 12 (2) ◽  
pp. 81-93
Author(s):  
Zahra Behboodi Moghadam ◽  
Elham Rezaei ◽  
Azam Rahmani

This study aimed to asses previous research results about bio-physiological alterations during pregnancy and postpartum, and make clear outlook about prevalence and related factors of sleep disorders during pregnancy and postpartum. In this review, the articles that published from 2000 to 2019 were reviewed. Related articles were searched from databases in English language. After evaluation of inclusion and exclusion criteria, articles were chosen and reviewed based on the University of York strategies. Sleep disorders in present study were classified according to the International Classification of Sleep Disorders-3. The search revealed 4449 articles, after evaluating and assessing qualified articles, finally 56 article selected to review. According to the results of this review, The prevalence of sleep disorders was almost 76%–97% in whole pregnancy. The most common sleep disorders included central disorders of hyper somnolence (waking up in the middle of the night, daytime sleepiness, sleeplessness) or insomnia, sleep-related movement disorders (restless legs syndrome), sleep related breathing disorders (obstructive sleep apnea), and parasomnia. In addition, sleep disorder may continue 3–12 months postpartum (33.2%). Sleep disorders induced by physiological processes (fetal movement, excessive weight gain, male sex of the fetus, and multiparty), health-related risks (metabolism disorders, cardiovascular diseases, and mood disorders), and physical or sexual abuse in childhood. In addition, these disorders could have maternal outcomes that can be greatest trigger to postpartum psychiatric disorders and fetal outcomes that have harmful sequences during childhood (sexual, fertility, emotional, and cognitive problems). Health care providers should evaluate the mothers’ sleep quality because sleep disorder leads to harmful consequences in fetuses and children.


2020 ◽  
Vol 162 (5) ◽  
pp. 612-621 ◽  
Author(s):  
Sean M. Parsel ◽  
Blair M. Barton ◽  
Sydney Beatty ◽  
Paul L. Friedlander

Objective To describe the level of knowledge of human papillomavirus (HPV) and HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) among the general population and health care providers. Data Sources Systematic search was performed on December 20, 2018, using MEDLINE (1966 to December 2018), EMBASE (1975 to December 2018), Web of Science (1900 to December 2018), and CENTRAL (1996 to December 2018) databases. English-language literature involving human subjects was used, and studies were limited to case series, case-control, cohort, and randomized controlled trial designs. Review Methods Studies were included if they assessed knowledge of HPV and HPV-associated OPSCC. The primary outcome measure was the knowledge of HPV-associated OPSCC among the general population and with health care providers. Meta-analysis of proportions was attempted using random-effects model. The PRISMA guidelines were used for accuracy of reporting. Results Thirty-two studies were included with 17,288 participants. There was a high degree of heterogeneity preventing completion of a meta-analysis. Knowledge of HPV and HPV-associated OPSCC varied between the general population and health care providers. The proportion of the general population and health care providers with knowledge of HPV ranged from 16% to 75% and 21% to 84%, respectively. Knowledge of HPV-associated OPSCC was greater in health care providers and ranged from 22% to 100% compared with the general population, which ranged from 7% to 57%. Conclusion There is a knowledge gap of HPV-associated OPSCC for both the general population and health care providers. Additional education may not only increase awareness but may also result in prevention and earlier detection.


2017 ◽  
Vol 3 (2_suppl) ◽  
pp. 4s-5s
Author(s):  
Miriam Cremer ◽  
Karla Alfaro ◽  
Mauricio Maza ◽  
Philip E. Castle ◽  
Albert Zevallos ◽  
...  

Abstract 22 Background: Screening followed by treatment has been a key contributor to the reduction of cervical cancer in industrialized countries and is critical to reduce its burden in low-resource countries. Screening technologies that are appropriate for low-resource settings have advanced considerably; however, treatment technologies have lagged. Treatment methods that are used in developing countries must be low cost, effective, and adaptable for areas with limited infrastructure and health care providers. This study was performed to determine the depth of necrosis in cervical tissue achieved with three treatment devices: conventional cryotherapy with CO2, the CryoPen (CryoPen, Corpus Christi, TX) adapted for low-resource settings, and the thermocoagulator. Methods: One hundred twenty-five women who were scheduled for hysterectomy for indications other than cervical pathology were randomly assigned to one of five treatment arms: single-freeze arms and double-freeze arms for both conventional cryotherapy and the adapted CryoPen, and a single application of thermoablation at 100° C for 40 seconds. Treatment was administered 12 to 24 hours before hysterectomy. Depth of necrosis in cervical specimens was measured by pathologists who were blinded to the treatment modality. Results: A total of 119 women have been enrolled to date, and 114 specimens have been reviewed. Mean depth of necrosis is 5.1 mm (0.9 to 8.5 mm) for single-freeze cryotherapy, 5.6 mm (3.8 to 10.5 mm) for double-freeze cryotherapy, 4.9 mm (3.5 to 8.5 mm) for single-freeze adapted CryoPen; 4.5 mm (3.0 to 7.3 mm) for double-freeze adapted CryoPen, and 3.7 mm (1.9 to 5.5 mm) for the thermoablation ( Table 1 ). Conclusion: The depths of necrosis achieved with the three different ablation modalities are competitive and surpass the targeted depth of 3.5 mm established a priori. Results thus far have demonstrated that devices that are optimized for use in low-resource settings can be as effective as conventional cryotherapy in treating cervical intraepithelial neoplasia. [Table: see text] AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST Miriam Cremer Honoraria: Merck Speakers' Bureau: Merck Travel, Accommodations, Expenses: Merck Other Relationship: Basic Health International Karla Alfaro No relationship to disclose Mauricio Maza No relationship to disclose Philip E. Castle No relationship to disclose Albert Zevallos No relationship to disclose Ana Cecilia Diaz de Uriarte No relationship to disclose Manuel Alvarez No relationship to disclose Manuel Salinas No relationship to disclose Ana Sofia Ore No relationship to disclose Luis Taxa No relationship to disclose Juan Felix Expert Testimony: Johnson & Johnson, Philip Morris


2011 ◽  
Vol 3 ◽  
pp. CMT.S5124
Author(s):  
Jamie N. Brown ◽  
Dustin T. Wilson

Objective To review the efficacy and safety of armodafinil for the treatment in patients with excessive sleepiness. Data sources Literature was accessed via MEDLINE (1966–February 2011) and EMBASE (1980–February 2011) using the medical subject heading terms armodafinil and sleep. Study selection and data extraction All English-language, peer-reviewed publications were analyzed for relevance. Studies appropriate to the objective were evaluated if they prospectively assessed the effectiveness of armodafinil in patients with excessive sleepiness in a multiple-dose, comparator trial. The literature search identified published reports of 7 randomized, placebo-controlled studies. Data synthesis Armodafinil is a wakefulness-promoting agent used in the treatment of patients with excessive sleepiness and is the R-enantiomer of modafinil. Studies have demonstrated that armodafinil may be effective and safe when used in patients with obstructive sleep apnea, circadian rhythm disorders, and narcolepsy. Although the studies identified had limited sample sizes, they consistently demonstrated improvement on various efficacy rating scales for sleep. Study durations ranged from 3 days to 12 weeks, with doses ranging from 50 mg to 250 mg daily. The most common adverse effects associated with armodafinil therapy were headache, nausea, diarrhea, dizziness, and anxiety, although increases in systolic blood pressure and pulse rate were also reported. Conclusion Current evidence suggests that armodafinil significantly improves wakefulness in patients with excessive sleepiness in studies up to 12 weeks. Long-term effectiveness and safety cannot be adequately determined at this time. Although armodafinil should be considered safe for use, health-care providers should monitor for adverse effects, particularly cardiovascular complications.


Sign in / Sign up

Export Citation Format

Share Document