Risks Of Medical Intervention Research Articles

Assessment by a clinical dentist definitions and risk of medical interventions

The article presents algorithms for assessing clinical certainty and risk by a dentist in the implementation of a specific medical intervention. The assessment of clinical certainty is prospective (prognostic) rather than retrospective in nature, which takes place during the examination of the quality of medical care, as well as control and surveillance activities. In this regard, a dentist, using a simple method of quantitative assessment of clinical certainty (risk), without the use of complex computational algorithms, is able to quickly navigate the level of complexity of medical intervention and personal readiness for its implementation.

Predictive value of head-perineum distance measured at the initiation of the active second stage of labor on the mode of delivery: A prospective cohort study

ObjectiveThe objective was to assess the predictive value of head-perineum distance measured at the initiation of the active second stage of labor on the mode of delivery. Material and MethodsIt was a prospective cohort study in an academic Hospital of Rennes, France, from July 1, 2020 to April 4, 2021 including 286 full-term parturients who gave birth to a newborn in cephalic presentation. A double-blind ultrasound measurement of the head-perineum distance was performed during the second phase of labor within five minutes after the onset of pushing efforts. The primary outcome was the mode of delivery (spontaneous vaginal delivery versus instrumental vaginal delivery or cesarean section). We performed a multivariate analysis to determine the predictive value of the head-perineum distance by adjusting on potential confounders. ResultsOverall, 199 patients delivered by spontaneous vaginal delivery, 80 by instrumental vaginal delivery, and seven by cesarean section. The head-perineum distance measured at the beginning of pushing efforts was predictive of the mode of delivery with a threshold at 44 mm (crude: sensitivity = 56.8 % and specificity = 79.3 %; adjusted: sensitivity = 79.4 % and specificity = 87.4 %). The risk of medical intervention was higher when the head-perineum distance is>44 mm with an adjusted OR of 2.78 [1.38; 5.76]. ConclusionThe head-perineum distance measured at the initiation of the active second stage of labor is predictive of the mode of delivery. Head-perineum distance below 44 mm predicts a vaginal delivery with the best diagnostic performance, and optimizes the time to start pushing efforts.

Current bioethical problems and their legal dimension

Considering the contemporary bioethical problems that have become aggravated in conditions of the new coronavirus pandemic (COVID-19), the author comes to the conclusion that their criminal-legal “dimension” is derived from positive regulation. Criminal liability for acts related to the use of new biotechnologies can be established only if they are “primary” prohibited in medical legislation. The assessment of the justification of the risks of medical intervention from the position of art. 41 of the Criminal Code of the Russian Federation is directly linked with the observance of the rules of medical care, which already contain acceptable risk limits. If at the level of primary positive regulation there is no required legal distinctness (as in the situation with the “collision of lives” of patients with the same medical indicators), then the corresponding bioethical problem cannot be resolved by criminal legal means.

Clinical Practice Guideline: Sudden Hearing Loss (Update) Executive Summary.

ObjectiveSudden hearing loss is a frightening symptom that often prompts an urgent or emergent visit to a health care provider. It is frequently, but not universally, accompanied by tinnitus and/or...

Clinical Practice Guideline: Sudden Hearing Loss (Update).

ObjectiveSudden hearing loss is a frightening symptom that often prompts an urgent or emergent visit to a health care provider. It is frequently but not universally accompanied by tinnitus and/or v...

The efficacy and stability of an information and communication technology-based centralized monitoring system of adherence to immunosuppressive medication in kidney transplant recipients: study protocol for a randomized controlled trial

BackgroundImmunosuppression non-adherence in kidney transplant recipients (KTRs) not only increases the risk of medical intervention due to acute rejection and graft loss but burdens the socioeconomic system in the form of increased healthcare costs. An aggressive preemptive effort by healthcare professionals, geared to ensure adherence to immunosuppressants in KTRs, is significant and imperative.Methods/designThis study was designed as a prospective, open-label, multicenter, randomized controlled study aimed at evaluating the efficacy and stability of an information and communication technology (ICT)-based centralized monitoring system in boosting medication adherence in KTRs. One hundred fourteen KTRs registered throughout the year 2017 to 2018 are randomized into either the ICT-based centralized home monitoring system or to ambulatory follow-up. The planned follow-up duration is 6 months. The ICT-based centralized home monitoring system described consists of a smart pill box equipped with personal identification system, a home monitoring system, an electronic Case Report Form (eCRF) system, and a comprehensive clinical trial management system (CTMS). It alerts both patients and medical staff with texts and pill box alarms if there is a dosage/dosing time error or a missed dose. Medication adherence and transplant outcomes for the follow-up period are compared between the two groups, while patient satisfaction as well as the stability and cost-effectiveness of the ICT-based monitoring system are to be evaluated.DiscussionThis on-going study is expected to determine if consistent use of the ICT-based centralized monitoring system described could maximize mediation adherence and subsequently enhance transplant outcomes in KTRs. Further, it would lay the foundation for successful implementation of this ICT-based monitoring system for effective management of medication adherence in KTRs.Trials registrationClinicalTrials.gov, Identifier: NCT03136588. Registered on 20 April 2017.

Ist das Zeitalter der Kausalität vorbei?

For the assessment of diagnostic and therapeutic interventions a sound scientific base has been developed during the last twenty years. Under the headline of Evidence-based Medicine nowadays a comprehensive set of tools is offered which can be used to assess the benefit and the risk of medical interventions. The overarching rule which evolved for the grading of evidence from studies is to maximize the protection against bias. Despite this coherent approach, there is still controversy that is regularly mainly sparked by the dominant position of randomized controlled trials. Observational studies and registries are deemed to be more relevant because they provide results that are produced under "everyday conditions". These controversial discussions often show a lack of orientation, as they do without the explicit naming of scientific criteria for the evaluation and to a large extent rely on common sense. That the latter may not be a good guide for assessments in the medical field is known from numerous studies. For unbiased assessments the rigorous use of basic scientific principles is the only way. To express doubt and question these principles requires a scientific basis itself. The alternative is to move away from the established scientific foundation. The path to a "new" scientific paradigm is currently dominated by a discussion under the buzzword Big Data. Defined by the three V's of Variety, Velocity and Volume, a potential of the unlimited analysis of data is envisioned, for which there is currently no validation and whose logical foundations are extremely doubtful. The demand must be reaffirmed that instead of promises strict validation criteria be followed for the evaluation of all interventions in medicine, particularly in view of these developments.

Quantifying Benefit–Risk Preferences for Medical Interventions: An Overview of a Growing Empirical Literature

Decisions regarding the development, regulation, sale, and utilization of pharmaceutical and medical interventions require an evaluation of the balance between benefits and risks. Such evaluations are subject to two fundamental challenges-measuring the clinical effectiveness and harms associated with the treatment, and determining the relative importance of these different types of outcomes. In some ways, determining the willingness to accept treatment-related risks in exchange for treatment benefits is the greater challenge because it involves the individual subjective judgments of many decision makers, and these decision makers may draw different conclusions about the optimal balance between benefits and risks. In response to increasing demand for benefit-risk evaluations, researchers have applied a variety of existing welfare-theoretic preference methods for quantifying the tradeoffs decision makers are willing to accept among expected clinical benefits and risks. The methods used to elicit benefit-risk preferences have evolved from different theoretical backgrounds. To provide some structure to the literature that accommodates the range of approaches, we begin by describing a welfare-theoretic conceptual framework underlying the measurement of benefit-risk preferences in pharmaceutical and medical treatment decisions. We then review the major benefit-risk preference-elicitation methods in the empirical literature and provide a brief overview of the studies using each of these methods. The benefit-risk preference methods described in this overview fall into two broad categories: direct-elicitation methods and conjoint analysis. Rating scales (6 studies), threshold techniques (9 studies), and standard gamble (2 studies) are examples of direct elicitation methods. Conjoint analysis studies are categorized by the question format used in the study, including ranking (1 study), graded pairs (1 study), and discrete choice (21 studies). The number of studies reviewed here demonstrates that this body of research already is substantial, and it appears that the number of benefit-risk preference studies in the literature will continue to increase. In addition, benefit-risk preference-elicitation methods have been applied to a variety of healthcare decisions and medical interventions, including pharmaceuticals, medical devices, surgical and medical procedures, and diagnostics, as well as resource-allocation decisions such as facility placement. While preference-elicitation approaches may differ across studies, all of the studies described in this review can be used to provide quantitative measures of the tradeoffs patients and other decision makers are willing to make between benefits and risks of medical interventions. Eliciting and quantifying the preferences of decision makers allows for a formal, evidence-based consideration of decision-makers' values that currently is lacking in regulatory decision making. Future research in this area should focus on two primary issues-developing best-practice standards for preference-elicitation studies and developing methods for combining stated preferences and clinical data in a manner that is both understandable and useful to regulatory agencies.

Clinical Practice Guideline

Sudden hearing loss (SHL) is a frightening symptom that often prompts an urgent or emergent visit to a physician. This guideline provides evidence-based recommendations for the diagnosis, management, and follow-up of patients who present with SHL. The guideline primarily focuses on sudden sensorineural hearing loss (SSNHL) in adult patients (aged 18 and older). Prompt recognition and management of SSNHL may improve hearing recovery and patient quality of life (QOL). Sudden sensorineural hearing loss affects 5 to 20 per 100,000 population, with about 4000 new cases per year in the United States. This guideline is intended for all clinicians who diagnose or manage adult patients who present with SHL. The purpose of this guideline is to provide clinicians with evidence-based recommendations in evaluating patients with SHL, with particular emphasis on managing SSNHL. The panel recognized that patients enter the health care system with SHL as a nonspecific, primary complaint. Therefore, the initial recommendations of the guideline deal with efficiently distinguishing SSNHL from other causes of SHL at the time of presentation. By focusing on opportunities for quality improvement, the guideline should improve diagnostic accuracy, facilitate prompt intervention, decrease variations in management, reduce unnecessary tests and imaging procedures, and improve hearing and rehabilitative outcomes for affected patients. The panel made strong recommendations that clinicians should (1) distinguish sensorineural hearing loss from conductive hearing loss in a patient presenting with SHL; (2) educate patients with idiopathic sudden sensorineural hearing loss (ISSNHL) about the natural history of the condition, the benefits and risks of medical interventions, and the limitations of existing evidence regarding efficacy; and (3) counsel patients with incomplete recovery of hearing about the possible benefits of amplification and hearing-assistive technology and other supportive measures. The panel made recommendations that clinicians should (1) assess patients with presumptive SSNHL for bilateral SHL, recurrent episodes of SHL, or focal neurologic findings; (2) diagnose presumptive ISSNHL if audiometry confirms a 30-dB hearing loss at 3 consecutive frequencies and an underlying condition cannot be identified by history and physical examination; (3) evaluate patients with ISSNHL for retrocochlear pathology by obtaining magnetic resonance imaging, auditory brainstem response, or audiometric follow-up; (4) offer intratympanic steroid perfusion when patients have incomplete recovery from ISSNHL after failure of initial management; and (5) obtain follow-up audiometric evaluation within 6 months of diagnosis for patients with ISSNHL. The panel offered as options that clinicians may offer (1) corticosteroids as initial therapy to patients with ISSNHL and (2) hyperbaric oxygen therapy within 3 months of diagnosis of ISSNHL. The panel made a recommendation against clinicians routinely prescribing antivirals, thrombolytics, vasodilators, vasoactive substances, or antioxidants to patients with ISSNHL. The panel made strong recommendations against clinicians (1) ordering computerized tomography of the head/brain in the initial evaluation of a patient with presumptive SSNHL and (2) obtaining routine laboratory tests in patients with ISSNHL.

Reproductive rights: Current issues of late abortion

This article considers the legal issues surrounding induced late abortion in cases when severe medical, therapeutic or ethical reasons have not been in dispute. Generally discussing the essential question about abortion today, it means not anymore legality of abortion but, in the first place, safety of abortion. From the aspect of woman health the most important aim is to detect and avoid possible risks of medical intervention, such as late abortion present. This is the matter of medical law context and also the matter of the woman's reproductive rights, here observed through legislation and court practice. The gynecologist has an obligation to obtain the informed consent of each patient. Information's should be presented in reasonably understandable terms and include alternative modes of treatment, objectives, risks, benefits, possible complications, and anticipated results of such treatment. Pregnant woman should receive supportive counseling before and particularly after the procedure. The method chosen for all terminations should ensure that the fetus is born dead. This should be undertaken by an appropriately trained practitioner. Reform in abortion law, making it legally accessible to woman, is not necessarily the product of a belief in woman's rights, but can be a means of bringing the practice of abortion back under better control. Counseling and good medical practice in performing late abortion are the instruments to drive this point even further home. It does not undermine the woman who wants to make a positive decision about her life and its purpose is not to produce feelings of insecurity and guilt. It concludes that existing law should not be changed but that clear rules should be devised and board created to review late term abortion. In Serbia, this leads to creation and set up guidelines for reconciling medical justification for late abortion with existing law, especially with solutions which brings comparative law. .

What do we know about communicating risk? A brief review and suggestion for contextualising serious, but rare, risk, and the example of cox-2 selective and non-selective NSAIDs.

BackgroundCommunicating risk is difficult. Although different methods have been proposed – using numbers, words, pictures or combinations – none has been extensively tested. We used electronic and bibliographic searches to review evidence concerning risk perception and presentation. People tend to underestimate common risk and overestimate rare risk; they respond to risks primarily on the basis of emotion rather than facts, seem to be risk averse when faced with medical interventions, and want information on even the rarest of adverse events.MethodsWe identified observational studies (primarily in the form of meta-analyses) with information on individual non-steroidal anti-inflammatory drug (NSAID) or selective cyclooxygenase-2 inhibitor (coxib) use and relative risk of gastrointestinal bleed or cardiovascular event, the background rate of events in the absence of NSAID or coxib, and the likelihood of death from an event. Using this information we present the outcome of additional risk of death from gastrointestinal bleed and cardiovascular event for individual NSAIDs and coxibs alongside information about death from other causes in a series of perspective scales.ResultsThe literature on communicating risk to patients is limited. There are problems with literacy, numeracy and the human tendency to overestimate rare risk and underestimate common risk. There is inconsistency in how people translate between numbers and words. We present a method of communicating information about serious risks using the common outcome of death, using pictures, numbers and words, and contextualising the information. The use of this method for gastrointestinal and cardiovascular harm with NSAIDs and coxibs shows differences between individual NSAIDs and coxibs.ConclusionAlthough contextualised risk information can be provided on two possible adverse events, many other possible adverse events with potential serious consequences were omitted. Patients and professionals want much information about risks of medical interventions but we do not know how best to meet expectations. The impact of contextualised information remains to be tested.

Moderación en la actividad médica preventiva y curativa. Cuatro ejemplos de necesidad de prevención cuaternaria en España

Medical activities have more positive than negative outcomes. Because this balance, medicine has a great social recognition. But with new technology and more agressive diagnostic and therapeutic interventions, there is a decreasing gap in between benefits and harms. Risk increases because more interventions, and because placing patients in more technology environments. As a consecuence, patient safety decreases. Quantity becomes as important as quality, and the place of care is crucial for patient safety. Medical activities should be of «low intensity and high quality», performed in the low level of care possible. Then, quaternary prevention (to avoid unnecessary use and risk of medical interventions) should be a continous parallel clinical activity. I consider four examples of needed quaternary prevention, with Spanish data: 1) cardiovascular prevention (where there is an inverse use of resources, as patients who need more receive less); 2) use of new antidepresants (which has provoke an artificial epidemic of «depression”); 3) use of antibiotics (frequently, unnecessary use), and 4) genetic diagnosis (with the example of screening of haemochromatosis, and a commentary about genetics and medicalisation).

Informing Patients and Explaining Risks

Two ethical principles, autonomy and veracity, underpin the imperative to inform and explain the risks of medical interven-tions to patients, but are not the only principles guiding clinical practice. They often conflict with the more traditional principles of beneficence and non-maleficience. ‘Informing’ patients can cause anxiety and uncertainty, undermining previously trusting therapeutic relationships.