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Surgery is a medical specialty that uses manual and/or instrumental techniques to physically reach into a subject's body in order to investigate or treat pathological conditions such as a disease or injury, to alter bodily functions, to improve appearance, or to remove/replace unwanted tissues or foreign bodies. The subject receiving the surgery is typically a person, but can also be a non-human animal.
A randomized controlled trial is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures or other medical treatments.
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.
In a blind or blinded experiment, information which may influence the participants of the experiment is withheld until after the experiment is complete. Good blinding can reduce or eliminate experimental biases that arise from a participants' expectations, observer's effect on the participants, observer bias, confirmation bias, and other sources. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. In some cases, while blinding would be useful, it is impossible or unethical. For example, it is not possible to blind a patient to their treatment in a physical therapy intervention. A good clinical protocol ensures that blinding is as effective as possible within ethical and practical constraints.
Intersex medical interventions, also known as intersex genital mutilations (IGM), are surgical, hormonal and other medical interventions performed to modify atypical or ambiguous genitalia and other sex characteristics, primarily for the purposes of making a person's appearance more typical and to reduce the likelihood of future problems. The history of intersex surgery has been characterized by controversy due to reports that surgery can compromise sexual function and sensation, and create lifelong health issues. Timing, evidence, necessity and indications for surgeries in infancy, adolescence or adult age have been controversial, associated with issues of consent.
The history of intersex surgery is intertwined with the development of the specialities of pediatric surgery, pediatric urology, and pediatric endocrinology, with our increasingly refined understanding of sexual differentiation, with the development of political advocacy groups united by a human qualified analysis, and in the last decade by doubts as to efficacy, and controversy over when and even whether some procedures should be performed.
Alosetron, sold under the brand name Lotronex among others, is a 5-HT3 antagonist used for the management of severe diarrhea-predominant irritable bowel syndrome (IBS) in females only.
A medical guideline is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare. Such documents have been in use for thousands of years during the entire history of medicine. However, in contrast to previous approaches, which were often based on tradition or authority, modern medical guidelines are based on an examination of current evidence within the paradigm of evidence-based medicine. They usually include summarized consensus statements on best practice in healthcare. A healthcare provider is obliged to know the medical guidelines of their profession, and has to decide whether to follow the recommendations of a guideline for an individual treatment.
A systematic review is a scholarly synthesis of the evidence on a clearly presented topic using critical methods to identify, define and assess research on the topic. A systematic review extracts and interprets data from published studies on the topic, then analyzes, describes, critically appraises and summarizes interpretations into a refined evidence-based conclusion. For example, a systematic review of randomized controlled trials is a way of summarizing and implementing evidence-based medicine.
Essure was a device for female sterilization. It is a metal coil which when placed into each fallopian tube induces fibrosis and blockage. Essure was designed as an alternative to tubal ligation. However, it was recalled by Bayer in 2018, and the device is no longer sold due to complications secondary to its implantation. The company has reported that several patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse effects, including: perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reaction. Although designed to remain in place for a lifetime, it was approved based on short-term safety studies. Of the 745 women with implants in the original premarket studies, 92% were followed up at one year, and 25% for two years, for safety outcomes. A 2009 review concluded that Essure appeared safe and effective based on short-term studies, that it was less invasive and could be cheaper than laparoscopic bilateral tubal ligation. About 750,000 women have received the device worldwide.
A hierarchy of evidence, comprising levels of evidence (LOEs), that is, evidence levels (ELs), is a heuristic used to rank the relative strength of results obtained from experimental research, especially medical research. There is broad agreement on the relative strength of large-scale, epidemiological studies. More than 80 different hierarchies have been proposed for assessing medical evidence. The design of the study and the endpoints measured affect the strength of the evidence. In clinical research, the best evidence for treatment efficacy is mainly from meta-analyses of randomized controlled trials (RCTs). Systematic reviews of completed, high-quality randomized controlled trials – such as those published by the Cochrane Collaboration – rank the same as systematic review of completed high-quality observational studies in regard to the study of side effects. Evidence hierarchies are often applied in evidence-based practices and are integral to evidence-based medicine (EBM).
A breast implant is a prosthesis used to change the size, shape, and contour of a person's breast. In reconstructive plastic surgery, breast implants can be placed to restore a natural looking breast following a mastectomy, to correct congenital defects and deformities of the chest wall or, cosmetically, to enlarge the appearance of the breast through breast augmentation surgery.
Transcatheter aortic valve replacement (TAVR) is the replacement of the aortic valve of the heart through the blood vessels. The replacement valve is delivered via one of several access methods: transfemoral, transapical, subclavian, direct aortic, and transcaval, among others.
Unwarranted variation in health care service delivery refers to medical practice pattern variation that cannot be explained by illness, medical need, or the dictates of evidence-based medicine. It is one of the causes of low value care often ignored by health systems.
The bidirectional Glenn (BDG) shunt, or bidirectional cavopulmonary anastomosis, is a surgical technique used in pediatric cardiac surgery procedure used to temporarily improve blood oxygenation for patients with a congenital cardiac defect resulting in a single functional ventricle. Creation of a bidirectional shunt reduces the amount of blood volume that the heart needs to pump at the time of surgical repair with the Fontan procedure.
The Jadad scale, sometimes known as Jadad scoring or the Oxford quality scoring system, is a procedure to assess the methodological quality of a clinical trial by objective criteria. It is named after Canadian-Colombian physician Alex Jadad who in 1996 described a system for allocating such trials a score of between zero and five (rigorous). It is the most widely used such assessment in the world, and as of 2022, its seminal paper has been cited in over 23,000 scientific works.
The Global Initiative for Emergency and Essential Surgical Care was established by the World Health Organization in December 2005. Its general purpose is to reduce "death and disability from road traffic accidents, trauma, burns, falls, pregnancy related complications, domestic violence, disasters and other emergency surgical conditions" by improving collaborations between relevant organizations, institutions, and agencies. Specific objectives include improving basic medical supplies at district hospitals, as well as better training for staff to bolster medical standards and care.
Outcomes research is a branch of public health research which studies the end results of the structure and processes of the health care system on the health and well-being of patients and populations. According to one medical outcomes and guidelines source book - 1996, Outcomes research includes health services research that focuses on identifying variations in medical procedures and associated health outcomes. Though listed as a synonym for the National Library of Medicine MeSH term "Outcome Assessment ", outcomes research may refer to both health services research and healthcare outcomes assessment, which aims at Health technology assessment, decision making, and policy analysis through systematic evaluation of quality of care, access, and effectiveness.
The Comparative Effectiveness Research Translation Network (CERTAIN) is a learning healthcare system in Washington State focused on patient-centered outcomes research (PCOR) and comparative effectiveness research (CER), leveraging existing healthcare data for research and healthcare improvement, incorporating patient and other healthcare stakeholder voices into research, and facilitating dissemination and implementation of research evidence into clinical practice.
References
- ↑ McCulloch P, Altman DG et al. "No surgical innovation without evaluation: the IDEAL recommendations." Lancet. 2009 Sep 26;374(9695):1105-12. doi: 10.1016/S0140-6736(09)61116-8.
- ↑ "IDEAL Proposals for actions which would improve the environment for invasive therapy research". IDEAL. Archived from the original on 19 March 2017. Retrieved 17 February 2014.
- ↑ Peter McCulloch — Nuffield Department of Surgical Sciences Archived November 20, 2012, at the Wayback Machine
- ↑ "Transcript for Public Workshop - Bridging the IDEAL and TPLC Approaches for Evidence Development for Surgical Medical Devices and Procedures". fda.gov. U.S. Food and Drugs Administration. December 2, 2011. Retrieved 17 February 2014.
- ↑ "Strengthening Our National System for Medical Device Postmarket Surveillance" (PDF). fda.gov. U.S. Food and Drug Administration. September 2012. Retrieved 17 February 2014.
- ↑ McCulloch P. "The EU's system for regulating medical devices." BMJ. 2012 Oct 24;345:e7126. doi: 10.1136/bmj.e7126.
- ↑ "McCulloch P, Barkun J, Sedrakyan A; IDEAL Collaboration. "Implantable device regulation in Europe." Lancet. 2012 Aug 25;380(9843):729. doi: 10.1016/S0140-6736(12)61405-6.
- ↑ McCulloch P. "Wanted: an appropriate evaluation template." BMJ. 2011 Jun 7;342:d3540. doi: 10.1136/bmj.d3540.