Requirements For Approval Research Articles

Policy change to improve access to safe abortion care in federal Nepal.

In Nepal's constitution, safe abortion care is recognized as an essential component of a comprehensive approach to fulfill individuals' sexual and reproductive health and rights. In the current context of transition to a three-level governance (federal, provincial, and local), there are opportunities to accelerate decentralization and devolution of decision-making power, increase access to and coverage of safe abortion services, and improve health outcomes. This article documents the processes and results of the policy change undertaken by the Ministry of Health and Population in collaboration with development partners to decentralize the approval process of safe abortion sites and providers with the objective to increase access to and coverage of safe abortion services. With the decentralization of certification, the approval process for safe abortion service sites and providers has become simpler, less time consuming, and less expensive by reducing cost of traveling to Kathmandu or approaching authorities at the federal level. This has resulted in expanding safe abortion services across the country including remote areas with marginalized populations. Evidence-based advocacy enabled policy change for decentralization of the approval process. Collaboration among stakeholders has been vital for implementing the policy change, including issuing directives from the federal to provincial levels and capacity strengthening of provincial level officials in understanding the requirements for approval of sites and providers.

Entrustable professional activities in postgraduate general surgery training: a scoping review protocol

IntroductionThe competency-based medical education (CBME) movement continues to gain momentum in postgraduate physician training, resulting in increasing interest among surgical training programmes on how to implement it effectively. Entrustable professional...

Iterative Development, Validation, and Certification of a Smartphone System to Assess Neonatal Jaundice: Development and Usability Study.

Medical device development is an area facing multiple challenges, resulting in a high number of products not reaching the clinical setting. Neonatal hyperbilirubinemia, manifesting as neonatal jaundice (NNJ), is an important cause of newborn morbidity and mortality. It is important to identify infants with neonatal hyperbilirubinemia at an early stage, but currently there is a lack of tools that are both accurate and affordable. This study aimed to develop a novel system to assess the presence of NNJ. The device should provide accurate results, be approved as a medical device, be easy to use, and be produced at a price that is affordable even in low-resource settings. We used an iterative approach to develop a smartphone-based system to detect the presence of NNJ. We performed technical development, followed by clinical and usability testing in parallel, after which we initiated the regulatory processes for certification. We updated the system in each iteration, and the final version underwent a clinical validation study on healthy term newborns aged 1 to 15 days before all documentation was submitted for conformity assessment to obtain Conformité Européenne (CE) certification. We developed a system that incorporates a smartphone app, a color calibration card, and a server. Three iterations of the smartphone-based system were developed; the final version was approved as a medical device after complying with Medical Device Regulation guidelines. A total of 201 infants were included in the validation study. Bilirubin values using the system highly correlated with total serum or plasma bilirubin levels (r=0.84). The system had a high sensitivity (94%) to detect severe jaundice, defined as total serum or plasma bilirubin >250 µmol/L, and maintained a high specificity (71%). Our smartphone-based system has a high potential as a tool for identifying NNJ. An iterative approach to product development, conducted by working on different tasks in parallel, resulted in a functional and successful product. By adhering to the requirements for regulatory approval from the beginning of the project, we were able to develop a market-ready mobile health solution.

Knowledge, beliefs and practices towards HIV/AIDS among adolescents in India: A scoping review protocol.

Acquired Immune Deficiency Syndrome (AIDS) is a major health concern among Indian adolescents (10-19 years). Indian adolescents lack adequate knowledge about HIV/AIDS and adopt wrong practices. The present scoping review aims to understand the status of knowledge, beliefs and practices among Indian adolescents about HIV or HIV/AIDS. The present study will also focus on their understanding and the source of knowledge and awareness regarding HIV/AIDS. The recommendations of Arksey and O'Malley in 2005, Levac et al. in 2010 and The Joanna Briggs Institute Reviewers' manual in 2015 to conduct a systematic scoping review will be employed. The review questions, eligibility criteria and search strategy for this study will be ensured by the Population, Concept and Context (PCC) strategy. The Preferred Reporting Items for Systemic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) will be used for reporting of this scoping review. The methodological quality of all the relevant studies will be assessed by the Mixed Methods Appraisal Tool (MMAT), Version- 2018. Literature search will be carried out by using electronic databases such as PubMed, APA PsycInfo, EMBASE, and Google Scholar. Cross-references will be used to extract additional studies. As the planned study is based on secondary data and doesn't involve human and animal subjects, there is no requirement for formal ethical approval. The planned scoping review is the first of such study on the topic of HIV/AIDS among adolescent population in India as per the electronically available literature.There will be quality assessment of all the included studies.A thorough search strategy will be conducted as per the recommendations of the experts in scoping review search.On limitation side, the planned study will only utilize electronically available resources/evidences that are written in English language.The planned evidence based study will be of much help for the healthcare professionals and policy makers.

Robotic assisted rectal disk excision: the 3-cm diameter cut off may be abandoned

To describe the robotic full-thickness rectal excision using a transanal circular stapler in rectovaginal endometriosis nodule infiltrating the rectum >3 cm. Surgical video article. The local institutional review board was consulted, and the requirement for institutional review board approval was waived because the video describes a technique and the patient cannot be identified whatsoever. Written informed consent was obtained from the patient for the use of personal data. A tertiary referral center. Patients undergoing excision of rectal endometriosis. Standardized technique of full-thickness disk excision of large rectovaginal endometriosis nodules employing a combined robotic and trans anal approach. Feasibility of the technique. The technique is designed for deep rectovaginal nodules infiltrating middle and low-rectum up to 3 to 5 cm in length. The procedure was performed with robotic assistance. The 7-degree freedom mobility of the robotic scissors allows for a deep rectal shaving, with the goal of progressive reduction of the thickness of rectal wall. The scissors follow the rectal wall tangentially and leave behind a thin rectal wall which can be bent and pushed into the trans anal stapler's jaws. We employed end-to-end, 33 mm-diameter, circular trans anal staplers to increase the area of rectal wall to be caught into the stapler. A stitch was placed on the superior and the inferior limits of the shaved area, then the shaved area was bent and pushed into the stapler by tying a suture. The general surgeon closed and fired the stapler, then the stapler was removed together with a rectal patch of 4- to 6-cm diameter. The procedure ended in the bubble test which checked the integrity of the stapled line. Supplementary stitches may be placed to reinforce the suture, if required. The preliminary rectal shaving represents the real keystone of this procedure, and our experience suggests that the robotic assistance improves its feasibility in large nodule responsible for intrarectal protrusion.

Interchangeability of generic drugs for subpopulations: Bioequivalence simulation from a nonparametric PK model of gabapentin generic drugs.

We aim to identify pathophysiological pharmacokinetic subpopulations for whom there is a difference in comparative bioavailability compared to a healthy population. We used simulated exposures from a nonparametric model of multiple generics and the originator gabapentin. Exposure was simulated for virtual populations with pharmacokinetic characteristics beyond those of healthy subjects with regard to rate of absorption, volume of distribution and reduced renal function. Virtual parallel design bioequivalence studies were performed using a random sample of 24 simulated subjects, with standard acceptance criteria. Results indicated increased pharmacokinetic variability for patient populations with a lower rate of absorption or a reduced renal function, but no change in the average comparable bioavailability ratio. This increased variability results in a reduced likelihood of demonstrating bioequivalence. Observations were similar for comparisons between all different formulations, as well as between subjects who received the identical formulation in a repeated fashion. No relevant effect was observed for simulations with increased volume of distribution. Our simulations indicate that the reduced likelihood of demonstrating bioequivalence for subjects with altered pharmacokinetics is not influenced by a formulation switch, nor does the average comparable bioavailability ratio change, therefore these results support generic interchangeability and current approval requirements for generics.

Bench-to-bedside: Feasibility of nano-engineered and drug-delivery biomaterials for bone-anchored implants and periodontal applications.

Nanotechnology and drug-release biomaterials have been thoroughly explored in the last few years aiming to develop specialized clinical treatments. However, it is rare to find biomaterials associated with drug delivery properties in the current dental market for application in oral bone- and periodontal-related procedures. The gap between basic scientific evidence and translation to a commercial product remains wide. Several challenges have been reported regarding the clinical translation of biomaterials with drug-delivery systems (BDDS) and nanofeatures. Therefore, processes for BDDS development, application in preclinical models, drug delivery doses, sterilization processes, storage protocols and approval requirements were explored in this review, associated with tentative solutions for these issues. The diversity of techniques and compounds/molecules applied to develop BDDS demands a case-by-case approach to manufacturing and validating a commercial biomaterial. Promising outcomes such as accelerated tissue healing and higher antibacterial response have been shown through basic and preclinical studies using BDDS and nano-engineered biomaterials; however, the adequate process for sterilization, storage, cost-effectiveness and possible cytotoxic effects remains unclear for multifunctional biomaterials incorporated with different chemical compounds; then BDDSs are rarely translated into products. The future benefits of BDDS and nano-engineered biomaterials have been reported suggesting personalized clinical treatment and a promising reduction in the use of systemic antibiotics. Finally, the launch of these specialized biomaterials with solid data and controlled traceability onto the market will generate strong specificity for healthcare treatments.

Effectiveness of physical and mental health interventions for young people with heart conditions: protocol for a systematic review and meta-analysis

IntroductionCardiovascular disease is among the most common of non-communicable diseases, affecting 13.9 million children and young people (CYP) globally. Survival rates for CYP with heart conditions are rising, however, support...

Patient-reported well-being in value-based care using tildrakizumab in a real-world setting: protocol of a multinational, phase IV, 1-cohort prospective observational study (the POSITIVE study)

IntroductionPsoriasis is a chronic inflammatory skin disease that negatively impacts the quality of life of patients and their families. However, the most commonly used decision-making tools in psoriasis, Psoriasis Area...

Resource Utilization and the Use of Bone Stimulators among Operatively and Nonoperatively Managed Scaphoid Nonunion Patients.

We used the 2009-2017 Truven Marketscan Research Databases to identify patients with closed scaphoid fractures and performed an analysis of variance test to determine resource utilization and bone stimulator use among these patients. A total of 36,611 patients with scaphoid fractures were identified: 30,143 were managed nonoperatively and 6468 were managed operatively. Nonunion was diagnosed in 500 (1.66%) nonoperatively and in 1211 (19%) operatively managed patients. Bone stimulators were used in less than 2% of nonoperatively and operatively managed scaphoid nonunion patients. Lack of trust in the technology and heterogenous (and occasionally burdensome) requirements for insurance approval are barriers to bone stimulator use; however, surgeons should examine how this technology may fit into the treatment algorithm for these difficult cases.

A Review on Strategies for COVID-19 Vaccine Development and Regulatory Requirements

Scientists first identified Human Coronavirus in the year 1965. Then, a study was performed on different human and animal viruses, which were named based on their crown-like appearance. Human coronaviruses are responsible for many children's upper respiratory tract infections. At least five new human coronaviruses have been identified since 2003, including the severe acute respiratory syndrome (SARS) coronavirus, which caused significant morbidity and mortality.1 Per NL and the New Haven, the virus associated with upper and lower respiratory tract disease and likely common human pathogens are identified as the Group-I coronaviruses (SARS- CoV-I). The novel coronavirus (SARS-CoV-II), which appeared in Wuhan, China, in December 2019, is responsible for Coronavirus disease 2019 (COVID-19) and causes respiratory symptoms that can feel like a cold, flu, or pneumonia. Geographical transmission of the virus and the sudden increase in cases are much faster than SARS and Middle East respiratory syndrome (MERS). COVID-19 is the first global pandemic caused by a coronavirus causing outbreaks in 211 countries. The vaccine against COVID-19 is an effective prophylactic strategy for controlling and preventing the virus. The vaccine is being developed in about 90 institutions worldwide. This research paper focuses on COVID-19 vaccine development strategies implemented by various institutions and pharmaceutical companies worldwide and regulatory requirements for vaccine approval.
 Keywords: Human Coronavirus, Severe Acute Respiratory Syndrome (SARS), COVID-19 vaccine development strategies

Clinical trials of novel psychotropic agents: some caveats.

Clinical trials of novel psychotropic agents: some caveats.

Concepts and applications of pharmacokinetic parameters: A guide for the classroom

Context: Pharmacokinetic studies play a fundamental role in making informed decisions during the drug development stage and fulfilling regulatory agencies' requirements for drug approval. Disposition profiles of plasma drug concentrations over time can be characterized by using non-compartmental analysis, compartmental and physiological-based modeling. These models allow us to determine the pharmacokinetic parameters that best describe the absorption, distribution, metabolism, and excretion (ADME) processes. Aims: To develop a conceptual and practical guide for the classroom on the most relevant pharmacokinetic parameters and their applications. Results: The apparent volume of distribution (Vd), systemic drug clearance (CL), bioavailability (F) and elimination half-life (t1/2) are among the most relevant pharmacokinetic parameters discussed in this article. The Vd describes the relationship at equilibrium between the amount of drug in the body and its plasma concentrations after distribution, used to calculate the initial dose to reach the target drug concentration. The CL describes the relationship between plasma drug concentrations and the rate of elimination from the body, allowing calculation of a maintenance dosing rate to maintain an average target concentration at steady-state. The t1/2 is the time required to halve the plasma drug concentration, whereas F is critical to understand the biological performance of the drug formulation. Conclusions: In this teacher's topic text, we emphasize the importance of these parameters for optimizing strategies of model-informed dose individualization. Indeed, they are crucial for predicting systemic drug exposures and how long the drug will last in the body, as well as time to steady state after multiple-dosing regimens.

A legislative framework for shareholder approval of political donations and expenditure by companies in South Africa

Political donations and expenditure by companies raise serious concerns due to poor corporate governance practices, which include the lack of accountability of directors to shareholders. The shareholders’ right to vote is one of the company-law mechanisms that may be used to control the directors’ discretion regarding political donations and expenditure. However, the Companies Act 71 of 2008 does not give shareholders the right to approve a company’s political donations or expenditure. Consequently, the directors enjoy a wide general discretion regarding a company’s political donations and expenditure. The article examines certain key policy considerations concerning the introduction of prior shareholder approval of political donations and expenditure by companies in South Africa. It examines the legislative requirements regarding shareholder approval of political donations and expenditure in the UK under Part 14 of the Companies Act, 2006, the philosophical rationale underpinning these legislative requirements, and the extent to which the introduction of shareholder approval of political donations and expenditure in the UK has achieved the underlying objectives of promoting transparency and accountability. The article then advocates for the introduction of the requirement for prior shareholder approval of political donations and expenditure under the South African Companies Act, and provides detailed recommendations on how such requirements could be implemented.

The International Nurse Regulator Collaborative Mobility Project: Transjurisdictional Mobility—Is It Possible?

Background The current global environment has led to increased mobility of nurses—and increasing pressure from governments to recruit more nurses into their workforces. Purpose To explore whether transjurisdictional mobility was possible, members of the International Nurse Regulator Collaborative (INRC) participated in research to investigate the possibility of recognizing existing licensure or registration and thereby reducing barriers and allowing for more streamlined mobility between INRC jurisdictions. Methods Using a mixed methods, multi-phased, multiple-case study design, regulatory processes and practices were investigated in each jurisdiction; findings were then compared across eight participating jurisdictions. Three research phases moved from a high-level jurisdictional overview, through expected standards underpinning nursing practice, to specific operational processes and outcomes. Issues and challenges in licensing/registering transjurisdictional INRC applicants were identified. Results A high level of consistency was found in the expectations, standards, and operational processes across jurisdictions. Challenges existed in relation to requirements for and assessments of educational qualifications despite entry to practice competencies and educational program approval requirements being largely the same. Jurisdictional regulators worked under different legislative frameworks, which may potentially create different challenges and timelines for moving toward transjurisdictional mobility. Balancing mobility with the core regulatory responsibility of maintaining public safety will be a key challenge. Conclusion Transjurisdictional mobility could potentially exist between jurisdictions with common regulatory principles, processes, and standards. Applicants moving between these jurisdictions present low risk. Streamlining processes could reduce regulatory workload while maintaining safety to the public. The current global environment has led to increased mobility of nurses—and increasing pressure from governments to recruit more nurses into their workforces. To explore whether transjurisdictional mobility was possible, members of the International Nurse Regulator Collaborative (INRC) participated in research to investigate the possibility of recognizing existing licensure or registration and thereby reducing barriers and allowing for more streamlined mobility between INRC jurisdictions. Using a mixed methods, multi-phased, multiple-case study design, regulatory processes and practices were investigated in each jurisdiction; findings were then compared across eight participating jurisdictions. Three research phases moved from a high-level jurisdictional overview, through expected standards underpinning nursing practice, to specific operational processes and outcomes. Issues and challenges in licensing/registering transjurisdictional INRC applicants were identified. A high level of consistency was found in the expectations, standards, and operational processes across jurisdictions. Challenges existed in relation to requirements for and assessments of educational qualifications despite entry to practice competencies and educational program approval requirements being largely the same. Jurisdictional regulators worked under different legislative frameworks, which may potentially create different challenges and timelines for moving toward transjurisdictional mobility. Balancing mobility with the core regulatory responsibility of maintaining public safety will be a key challenge. Transjurisdictional mobility could potentially exist between jurisdictions with common regulatory principles, processes, and standards. Applicants moving between these jurisdictions present low risk. Streamlining processes could reduce regulatory workload while maintaining safety to the public.

Inculcation of Employability Skills in Technical and Vocational Education: The Knowledge of Employability Skills and Teaching Practices

Employability skills are a requirement for TVE graduates to be eligible for employment. Employers not only place academic approval requirements and technical skills but employers emphasize employability skills. It becomes more complicated as employers shift the responsibility for inculcating these employability skills to educational institutions. Inculcating employability skills by TVE teachers is eSENtial in producing human capital that will drive the nation's progress and sustainability. Therefore, this study examines the level of inculcation of employability skills and knowledge of employability skills among TVE teacher as well as the relationship between these two variables. This quantitative survey involved 199 TVE teachers from Special Education Secondary Schools, in Malaysia. The instrument were adapted from Ab Halim’s (2013); Ab Majid’s (2017);Osman and Basar’s (2015). The findings showed that the level of inculcating employability skills and TVE teacher’s employability skill knowledge were at high-level with mean scores 4.28 (SD=0.441) and 3.92 (SD=0.38) respectively. Based on pearson correlation analysis, findings indicated that teacher’s employability skill knowledge positively correlates with the inculcation of employability skills (r = 0.512, p .000). The findings indicated that when teachers’s employability skills knowledge is high or increases, this will also increase their behavior to inculcate employability skills among the students. This study gives the impression that teachers' knowledge of employability skills is very important for them to inculcate employability skills among the students. The findings of this study can be used as a reference by the Malaysian Ministry of Education in improving teaching competence among TVE educators. In addition, a continous teacher professional development training related to knowledge of employability skills should be provided to TVE teachers. It would be good if the Malaysian Ministry of Education could collaborate with stakeholders to get more information on employability skills required by employers and industries. With that, teachers can inculcate accurate employability skills among the students as preparation before they step out for employment. The further study uses a mixed method by adding elements of observation also interview is needed to handle the issue.

Endovascular revascularisation versus surgical revascularisation in patients with lower limb atherosclerosis obliterans: a protocol for systematic review and meta-analysis with trial sequential analysis and meta-regression

IntroductionThe revascularisation strategy for lower limb atherosclerosis obliterans (ASO) remains controversial. In this meta-analysis, we will summarise existing evidence to compare the long-term and short-term outcomes between endovascular revascularisation and...

Toxicity parameters of an acidic detergent-disinfectant based on orthophosphate acid with polyhexamethyleneguanidine

The sanitary condition of milking equipment and dairy equipment is one of the main factors on which the quality and, primarily, the safety of the obtained products depend. According to the approved requirements, means for the sanitary treatment of milking equipment must have a broad antimicrobial spectrum, high bactericidal activity both in the absence and presence of organic substances and water hardness salts, destroy microorganisms that can form a biofilm, and are present in it, not cause an irritating effect on the skin of the hands, be non-toxic or low-toxic, etc. Therefore, to establish the disinfectant's compliance with the specified requirements, even at the stage of its development, it is envisaged to carry out toxicological studies aimed at determining toxicity, side effects, and the ability to accumulate in the body. Our work aimed to establish the toxicity parameters of the developed acidic detergent-disinfectant with polyhexamethyleneguanidine intended for the sanitary-hygienic treatment of milking equipment and dairy equipment. Indicators of acute toxicity of the developed disinfectant were determined in preliminary and extensive experiments. In a preliminary experiment, it was established that the administration of the native remedy to rats at a dose of 500, 1000, and 2000 mg/kg of body weight did not cause their death, while at a dose of 5000 mg/kg of body weight, it caused the death of the animals. In an acute experiment, it was established that the studied detergent-disinfectant based on orthophosphate acid with polyhexamethyleneguanidine at a dose of 2000 mg/kg of body weight did not cause the death of rats, while at a dose of 2500 mg/kg of body weight, it caused the death of 1 animal, at a dose of 3000 mg/kg – 2 animals, and in doses of 3500, 4000 and 4500 mg/kg of body weight – 4, 5 and 6 animals, respectively. Examining the acute toxicity of a 0.5 % solution of the studied disinfectant in doses of 1000, 2000, 3000, 4000, and 5000 mg/kg of body weight in a focused experiment and 5000 and 10000 mg/kg of body weight in an extended experiment, it was established that there were no dead or sick rats. It has been proven that, according to SOU 85.2-37-736:2011, the substance under study belongs to the IV toxicity class, which combines low-toxic substances, since its DL50 in its native form for white rats with intragastric administration is more than 3250 mg/kg of body weight, and 0.5 % solution – more than 10,000 mg/kg of body weight. In its native form, the developed disinfectant causes slight irritation of the skin and mucous membrane of the eyes of rabbits. At a concentration of 0.5 %, it has no irritating effect. The tool does not accumulate in the body, has no resorptive effect, and does not cause probable changes in the mass of internal organs. With long-term intragastric administration, it causes an increase in the number of leukocytes, hemoglobin and total protein, ALT, and AST activity (P < 0.001) and a decrease in the number of lymphocytes, monocytes, lipids and triglycerides, hematocrit value, alkaline phosphatase activity, lysozyme, and bactericidal activity.

The patterns, trends and major risk factors of suicide among Indian adolescents-A scoping review protocol.

Suicide is one of the serious health problems among Indian adolescents. Adolescence helps with the transition of an individual into an adult, so it is important to understand the suicidal behavior of adolescents. Several studies have been carried out in different states in India on the suicidal behavior of adolescents, but there is no review that studied the national patterns, trends, and major risk factors. Therefore, this review aims to study the patterns, trends, and major risk factors of suicidal behavior among Indian adolescents. The study will be conducted as per the Arksey and O'Malley scoping review framework and the Joanna Briggs institute Reviewers' manual. The Population, Concept and Context strategy (PCC) will ensure the review questions, eligibility criteria and search strategy. The Systematic Review and Meta-analysis: Extension for Scoping Review (PRISMA-ScR) will be used for the findings of the study of Scoping Review. The literature search will be done using electronic databases: PubMed, Google Scholar, SCOPUS, EMBASE, Psycinfo, Web of Science, Google, and Cochrane library by specific keywords such as "patterns"; "suicide"; "trends"; "risk factors"; "depression"; "anxiety"; "mental health"; "adolescent"; "teenager"; and "youth";" India" etc. Additional studies will be considered using cross-references. This study does not involve the collection of primary data; there is no requirement of any ethical approval. The proposed scoping review is the first study on patterns, trends, and major risk factors of adolescent suicide in India as per the information available on the online platforms.This proposed scoping review will bring together all the previously available data into one place for better study.This evidence-based study will be highly helpful for healthcare professionals and policymakers. This study will be limited to English language and electronically available evidence.

The Rise of Anti-TNF Biosimilars: Guidelines, Real-World Evidence, and Challenges to Acceptance

The over-production of TNF-α can lead to chronic inflammation and organ damage in immune-mediated inflammatory diseases (IMID), such as rheumatoid arthritis (RA), axial spondyloarthritis, psoriasis, and inflammatory bowel disease (IBD). Anti-TNF therapy is generally considered to be an effective, well-tolerated treatment option for the management of chronic inflammation in these conditions. Over the past decade, patents for the original reference anti-TNF agents have expired, permitting the development of anti-TNF products that are biologically similar, termed ‘biosimilar’, to the original reference product. Differences in the approval process mean that biosimilars are often available to healthcare services at a considerably lower cost compared with the reference products, providing an opportunity to improve patient access to the benefits of anti-TNF therapy. However, despite the spreading use of biosimilars across healthcare services, some clinicians remain reluctant to prescribe them. The gradual accumulation of long-term data on the real-world use of biosimilars, and an improved understanding of the development and approval process for these products, may help to increase clinicians’ confidence to increase usage of biosimilars. This mini review summarises the current status of anti-TNF biosimilars in clinical practice, including the requirements for regulatory approval, real-word evidence for their equivalence to novel anti-TNFs, guidelines for their use, and challenges to their acceptance by both clinicians and patients.