Strength Of Scientific Evidence Research Articles

To Bev or Not to Bev during Ovarian Cancer Maintenance Therapy?

Maintenance therapy with PARP inhibitors and bevacizumab is approved for ovarian cancer treatment in the first and second line settings, but selecting the optimal sequence is challenging due to restrictions on using the same medication twice. This review aims to establish guidelines for ovarian cancer maintenance therapy based on the strength of scientific evidence, the most effective treatment strategy, and the impact on the healthcare system. Six questions were formulated to evaluate the scientific evidence supporting different maintenance therapy options using the AGREE II guideline evaluation tool. The questions address the acceptability of reusing the same medication, the efficacy of bevacizumab and PARP inhibitors in the first and second line settings, the comparative efficacy of these medications, the potential benefit of combination maintenance therapy, and the economic impact of maintenance therapy. Based on the available evidence, bevacizumab should be preserved for second line maintenance therapy, and maintenance therapy with PARP inhibitors should be offered to all advanced ovarian cancer patients who have responded to first line platinum-based chemotherapy. Additional molecular predictors for bevacizumab efficacy are needed. The presented guidelines offer an evidence-based framework for selecting the most effective maintenance therapy for ovarian cancer patients. Further research is necessary to refine these recommendations and improve outcomes for patients with this disease.

The Polish Society of Gynecological Oncology Guidelines for the Diagnosis and Treatment of Endometrial Carcinoma (2023)

Due to the increasing amount of published data suggesting that endometrial carcinoma is a heterogenic entity with possible different treatment sequences and post-treatment follow-up, the Polish Society of Gynecological Oncology (PSGO) has developed new guidelines. to summarize the current evidence for diagnosis, treatment, and follow-up of endometrial carcinoma and to provide evidence-based recommendations for clinical practice. The guidelines have been developed according to standards set by the guideline evaluation tool AGREE II (Appraisal of Guidelines for Research and Evaluation). The strength of scientific evidence has been defined in agreement with The Agency for Health Technology Assessment and Tariff System (AOTMiT) guidelines for scientific evidence classification. The grades of recommendation have been based on the strength of evidence and the level of consensus of the PSGO development group. Based on current evidence, both the implementation of the molecular classification of endometrial cancer patients at the beginning of the treatment sequence and the extension of the final postoperative pathological report of additional biomarkers are needed to optimize and improve treatment results as well as to pave the route for future clinical trials on targeted therapies.

Evidence-Based Surgery

The practice of surgery has undergone a dramatic evolution over the last century with the availability of new scientific evidence supporting different surgical techniques and management. Evidence-based surgery is defined as the judicious and systematic application of scientific evidence to surgical decision making and the establishment of standards of surgical care. This includes efforts to appraise the strength of scientific evidence and evaluate the quality of research studies or evidence, as well as efforts to interpret and apply evidence to clinical practice. In this review, we discuss important methodology and approaches in surgical health services research to accomplish these goals and improve the quality of care in surgery. By providing this overview, we hope readers will be able to navigate the surgical literature and apply evidence-based science to their own surgical practice. This review contains 1 figure, 3 tables, and 43 references. Key words: bias, comparative effectiveness, confounding, evidence, external validity, implementation science, internal validity, pragmatic trials, quality, risk adjustment, surgery

Evidence-Based Surgery

The practice of surgery has undergone a dramatic evolution over the last century with the availability of new scientific evidence supporting different surgical techniques and management. Evidence-based surgery is defined as the judicious and systematic application of scientific evidence to surgical decision making and the establishment of standards of surgical care. This includes efforts to appraise the strength of scientific evidence and evaluate the quality of research studies or evidence, as well as efforts to interpret and apply evidence to clinical practice. In this review, we discuss important methodology and approaches in surgical health services research to accomplish these goals and improve the quality of care in surgery. By providing this overview, we hope readers will be able to navigate the surgical literature and apply evidence-based science to their own surgical practice. This review contains 1 figure, 3 tables, and 43 references. Key words: bias, comparative effectiveness, confounding, evidence, external validity, implementation science, internal validity, pragmatic trials, quality, risk adjustment, surgery

Comparison of International Therapy Guidelines with Regard to the Treatment of Malignant Catatonia.

Malignant catatonia (MC) is an extremely rare, life-threatening disorder. It is characterized by catatonic symptoms accompanied by autonomic instability, hyperthermia, and changes in laboratory values. In many cases, MC is not recognized as such. Evidence-based guidelines are essential to ensure quality of treatment, but what do current national and international guidelines recommend? Online search for international guidelines from English-, French-, Italian-, and German-speaking countries whose medical care meets high standards addressing the treatment of MC. These were analyzed and compared regarding statements on MC, recommendations, and strength of scientific evidence. Fifteen of the identified guidelines were included. Only 5 of 15 comment on the treatment of MC. As for other rare diseases, no detailed recommendations are available. Suggested therapies are limited to benzodiazepines and electroconvulsive therapy. Levels of evidence and grades of recommendation are predominantly low. Many international guidelines do not mention MC. It is not possible to derive a clear algorithm for the treatment of MC from most current guidelines. A thorough update of most guidelines appears to be necessary. Lack of awareness and knowledge of MC among physicians and medical professionals might lead to inadequate or delayed care, worsened outcome, or death.

Diagnostic and therapeutic guidelines for plaque psoriasis - Brazilian Society of Dermatology.

Psoriasis is a chronic inflammatory disease that affects 1.3% of the Brazilian population. The most common clinical manifestations are erythematous, scaling lesions that affect both genders and can occur on any anatomical site, preferentially involving the knees, elbows, scalp and genitals. Besides the impact on the quality of life, the systemic nature of the disease makes psoriasis an independent risk factor for cardiovascular disease, especially in young patients with severe disease. By an initiative of the Brazilian Society of Dermatology, dermatologists with renowned clinical experience in the management of psoriasis were invited to form a work group that, in a partnership with the Brazilian Medical Association, dedicated themselves to create the Plaque Psoriasis Diagnostic and Treatment Guidelines. The relevant issues for the diagnosis (evaluation of severity and comorbidities) and treatment of plaque psoriasis were defined. The issues generated a search strategy in the Medline-PubMed database up to July 2018. Subsequently, the answers to the questions of the recommendations were devised, and each reference selected presented the respective level of recommendation and strength of scientific evidence. The final recommendations for making up the final text were worded by the coordinators.

Communicating scientific evidence in qualified health claims

ABSTRACTQualified health claims (QHCs) are found on food and dietary supplement labels and aim to communicate the quality and strength of scientific evidence for a diet-disease relationship. Since the evidence varies for diet-disease relationships, the language to describe the evidence also varies. However, research indicates that consumers misinterpret QHCs as a whole product evaluation. The FDA is reviewing the evidence ranking system for QHCs and the current study aims to inform future consumer research. A content analysis examined the language used to convey scientific evidence in 53 QHCs and organized them into an intrinsic scale of evidence. Results revealed 36 formats to present the evidence in 53 QHCs. Seventy-seven percent (n = 41) demonstrate a reading level above 9th grade. Most claims describe the quality of evidence (n = 51, 96%) (“very weak”) and/or reference its consistency (n = 41, 77%), while a quarter (n = 13) also quantify the evidence (“two studies”). Twenty-five claims (47%) present the evidence before stating the diet-disease relationship. There is an absence of a systematic description of evidence among QHCs that may contribute to the misleading, albeit unintentional, nature of these claims. Policymakers might consider reforming QHC regulations so that a hierarchy of evidence for diet-disease relationships is clearly communicated to consumers.

Why Qualified Health Claims Do Not Work: A Content Analysis of Language Characteristics

The US Food and Drug Administration (FDA) regulates qualified health claims (QHCs) on food and dietary supplement labels. QHCs aim to communicate the quality and strength of scientific evidence behind the claim of a diet‐disease relationship. However, research shows that consumers understand QHCs as an indication of the overall healthfulness of a product. To understand the characteristics of QHCs and what may cause consumer confusion, a content analysis examined the language used to convey scientific evidence in 53, FDA‐enforced QHCs. The analysis revealed that 77% (n=41) of QHCs score above a 9th grade reading level. Most claims also describe the quality of evidence (n=51, 96%) (e.g. “very weak”), make reference to the consistency of evidence (n=41, 77%), while a quarter of claims (n=13) quantify the evidence (i.e. number of studies). Twenty‐five claims (47%) present the evidence before stating the diet‐disease relationship, while the remainder of QHCs present information in the reverse order (n=28, 53%). In the 53 QHCs studied, there are 36 ways in which evidence is presented, which likely contributes to consumer confusion. Regulators should consider whether reforming the language in QHCs would improve consumer understanding of these claims.

Femoral neck fracture in children: treatment and complications

description of the evidence colection Method Searches were conducted in the Medline database. The MeSH (Medical Subject Heading Terms) key-words used for the search were: “femoral neck”, “fractures/surgery”, “child”, “femoral neck fracture/complications”, “decompression surgical”, “internal fixation”. Thus, questions related to the topic were developed with a focus on the following aspects: types of treatment; best time to therapeutic approach; and ideal treatment with lower complication rates. Based on this, the questions were structured using PICO (pacient, intervention, comparison, outcome) methodology, and the search began with the selection of papers with better strength of scientific evidence.

Consensus of the Brazilian Society of Rheumatology for the diagnosis, management and treatment of lupus nephritis

ObjectiveTo develop recommendations for the diagnosis, management and treatment of lupus nephritis in Brazil. MethodExtensive literature review with a selection of papers based on the strength of scientific evidence and opinion of the Commission on Systemic Lupus Erythematosus members, Brazilian Society of Rheumatology. Results and conclusions(1) Renal biopsy should be performed whenever possible and if this procedure is indicated; and, when the procedure is not possible, the treatment should be guided with the inference of histologic class. (2) Ideally, measures and precautions should be implemented before starting treatment, with emphasis on attention to the risk of infection. (3) Risks and benefits of treatment should be shared with the patient and his/her family. (4) The use of hydroxychloroquine (preferably) or chloroquine diphosphate is recommended for all patients (unless contraindicated) during induction and maintenance phases. (5) The evaluation of the effectiveness of treatment should be made with objective criteria of response (complete remission/partial remission/refractoriness). (6) Angiotensin-converting enzyme inhibitors and/or angiotensin receptor blockers are recommended as antiproteinuric agents for all patients (unless contraindicated). (7) The identification of clinical and/or laboratory signs suggestive of proliferative or membranous glomerulonephritis should indicate an immediate implementation of specific therapy, including corticosteroids and an immunosuppressive agent, even though histological confirmation is not possible. (8) Immunosuppressives must be used during at least 36 months, but these medications can be kept for longer periods. Its discontinuation should only be done when the patient could achieve and maintain a sustained and complete remission. (9) Lupus nephritis should be considered as refractory when a full or partial remission is not achieved after 12 months of an appropriate treatment, when a new renal biopsy should be considered to assist in identifying the cause of refractoriness and in the therapeutic decision.

Consenso da Sociedade Brasileira de Reumatologia para o diagnóstico, manejo e tratamento da nefrite lúpica

ObjectiveTo develop recommendations for the diagnosis, management and treatment of lupus nephritis in Brazil. MethodExtensive literature review with a selection of papers based on the strength of scientific evidence and opinion of the Commission on Systemic Lupus Erythematosus members, Brazilian Society of Rheumatology. Results and conclusions1) Renal biopsy should be performed whenever possible and if this procedure is indicated; and, when the procedure is not possible, the treatment should be guided with the inference of histologic class. 2) Ideally, measures and precautions should be implemented before starting treatment, with emphasis on attention to the risk of infection. 3) Risks and benefits of treatment should be shared with the patient and his/her family. 4) The use of hydroxychloroquine (preferably) or chloroquine diphosphate is recommended for all patients (unless contraindicated) during induction and maintenance phases. 5) The evaluation of the effectiveness of treatment should be made with objective criteria of response (complete remission/partial remission/refractoriness). 6) ACE inhibitors and/or ARBs are recommended as antiproteinuric agents for all patients (unless contraindicated). 7) The identification of clinical and/or laboratory signs suggestive of proliferative or membranous glomerulonephritis should indicate an immediate implementation of specific therapy, including steroids and an immunosuppressive agent, even though histological confirmation is not possible. 8) Immunosuppressives must be used during at least 36 months, but these medications can be kept for longer periods. Its discontinuation should only be done when the patient achieve and maintain a sustained and complete remission. 9) Lupus nephritis should be considered as refractory when a full or partial remission is not achieved after 12 months of an appropriate treatment, when a new renal biopsy should be considered to assist in identifying the cause of refractoriness and in the therapeutic decision.

IOM Addresses Ongoing Effects of Blast Injury on Soldiers

Soldiers exposed to explosions during war are at increased risk of long-term adverse health outcomes, and better research is needed to understand how such blasts affect health and to learn how to treat veterans with blast exposure, conclude the authors of an Institute of Medicine (IOM) report. The report, “Gulf War and Health, Volume 9: Long-Term Effects of Blast Exposures,” released February 13, 2014 rates the strength of scientific evidence on health outcomes from exposure to blasts. It then makes recommendations for research most likely to provide the Department of Veterans Affairs (VA) the data it needs to determine how best to prevent blast injuries; diagnose them effectively; and manage, treat, and rehabilitate veterans of battlefield traumas, both in the immediate aftermath of a blast and in the long-term (http://tinyurl.com/oacgkxq). Language: en

Recommendations for the management and treatment of psoriatic arthritis

The members of the Comissão de Espondiloartrites da Sociedade Brasileira de Reumatologia (Commission on Spondyloarthritis of the Brazilian Society of Rheumatology, SBR) 2010-2012 took part in the Evidence Preparation Course given by the Associação Médica Brasileira (Brazilian Medical Association, AMB) in São Paulo in the first semester of 2011. The questions were finally concluded at a meeting of the Commission on Spondyloarthritis held on 15 October 2011 in Florianópolis (SC, Brazil), during the 18th Southern Cone Rheumatology Meeting and were later approved by all the coordinators of the Brazilian Spondyloarthritis Registry. The 15 clinical questions considered to be relevant were structured using the P.I.C.O. method (patient; intervention or indicator; comparison; outcome). The literature search was conducted by searching the databases MEDLINE, EMBASE, SciElo/Lilacs, and the Cochrane Library through February, 2012 (Appendix). Critical assessment of the evidence in the selected articles was performed using the Jadad score. Next, the answers to the questions included in the Recommendations were elaborated, and all the selected references exhibit the corresponding grade of recommendation and strength of scientific evidence. The references were updated through August, 2012, entered into a single file by the coordinator, and sent to the co-authors in two successive rounds for preparation of the final version. A. Most consistent experimental and observational studies. B. Less consistent experimental and observational studies. C. Case reports (uncontrolled studies). D. Opinion that is not substantiated by critical evaluation, based on consensus, physiological studies or animal models. To establish recommendations for the management (criteria for classification and clinical assessment) and treatment of psoriatic arthritis.

Recommendations for the management and treatment of systemic sclerosis

Description of the method to elaborate the evidence The members of the Comissao de Esclerose Sistemica da Sociedade Brasileira de Reumatologia (Systemic Sclerosis Commission of the Brazilian Society of Rheumatology, SBR) 2010- 2012 took part in the Evidence Preparation Course given by the Associacao Medica Brasileira (Brazilian Medical Association, AMB) in Sao Paulo in the first semester of 2011. The questions were formulated and discussed via internet in the second semester of 2011. The 15 clinical questions considered to be relevant were structured using the P.I.C.O. method (patient; intervention or indicator; comparison; outcome). The literature search was conducted by searching the databases MEDLINE, EMBASE, SciElo/Lilacs, and the Cochrane Library through February, 2012 (Appendix). Critical assessment of the evidence in the selected articles was performed using the Jadad score. The observational studies and case series were considered for analysis when randomised clinical trials could not be located. A manual search located the relevant studies that were included in the analysis. The answers to the questions included in the Recommendations were refined and elaborated, and all of the selected references exhibited the corresponding grade of recommendation and the strength of scientific evidence. The references were updated through December, 2012, entered into a single file by the coordinator, and sent to the co-authors in four successive rounds for preparation of the final version. Grades of recommendation and strength of evidence A. Most consistent experimental and observational studies. B. Less consistent experimental and observational studies. C. Case reports (uncontrolled studies). D. Opinion that is not substantiated by critical evaluation, based on consensus, physiological studies or animal models. Objective To establish recommendations for the management and treatment of systemic sclerosis.

Recommendations for the management and treatment of ankylosing spondylitis

Description of the method used for evidence preparation The members of the Comissao de Espondiloartrites da Sociedade Brasileira de Reumatologia (Commission on Spondyloarthritis of the Brazilian Society of Rheumatology, SBR) 2010–2012 took part in the Evidence Preparation Course given by the Associacao Medica Brasileira (Brazilian Medical Association, AMB) in Sao Paulo in the first semester of 2011. The questions were finally concluded at a meeting of the Commission on Spondyloarthritis held on 15 October 2011 in Florianopolis (SC, Brazil), during the 18th Southern Cone Rheumatology Meeting and were later approved by all the coordinators of the Brazilian Spondyloarthritis Registry. The 15 clinical questions considered to be relevant were structured using the P.I.C.O. method (patient; intervention or indicator; comparison; outcome). The literature search was conducted by searching the databases MEDLINE, EMBASE, SciElo/Lilacs, and the Cochrane Library through February, 2012 (Appendix). Critical assessment of the evidence in the selected articles was performed using the Jadad score. Next, the answers to the questions included in the Recommendations were elaborated, and all the selected references exhibit the corresponding grade of recommendation and strength of scientific evidence. The references were updated through August, 2012, entered into a single file by the coordinator, and sent to the co-authors in two successive rounds for preparation of the final version. Grades of recommendation and strength of evidence A: Most consistent experimental and observational studies. B: Less consistent experimental and observational studies. C: Case reports (uncontrolled studies). D: Opinion that is not substantiated by critical evaluation, based on consensus, physiological studies or animal models. Objective To establish recommendations for the management (classification and evaluation criteria by magnetic resonance and genetics) of spondyloarthritis and for the treatment of ankylosing spondyloarthritis.

Establishing and evaluating health claims for probiotics.

Establishing and evaluating health claims for probiotics.

Bracing and Taping Techniques and Patellofemoral Pain Syndrome

Reference/Citation: D'hondt NE, Struijs PA, Kerkhoffs GM, et al. Orthotic devices for treating patellofemoral pain syndrome. Cochrane Database Syst Rev. 2002;(2):CD002267. Clinical Question: Is the...

NTP‐CERHR expert panel report on the developmental toxicity of soy infant formula

NTP‐CERHR expert panel report on the developmental toxicity of soy infant formula

Application of Epidemiological Data for Decision Making: Health Claims

The Nutrition Labeling and Education Act (NLEA), which amended the Federal Food, Drug, and Cosmetic Act in 1990, authorized the use of health claims that are based on significant scientific agreement in food labeling. In 1994, the Dietary Supplement Health and Education Act (DSHEA) defined dietary supplements and created a legal framework for use of claims that is similar to the regulation of foods. Health claims describe the relationship between a substance (food or food component) and reduction of the risk of a disease or health-related condition; they are not intended as claims to cure, treat, mitigate, or prevent disease, which are considered drug claims. Since the enactment of the NLEA, the FDA has developed a process to evaluate scientific evidence in support of health claims. In 1999, the FDA published Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements. As a result of a series of court cases, the agency developed a process for qualified health claims that characterizes the quality and strength of scientific evidence because these claims are not based on significant scientific agreement. Since 2003, the FDA has published several letters of enforcement discretion for qualified health claims that illustrate the agency's approach to evaluating the scientific literature when the strength of the evidence is not consistent with significant scientific agreement. In 2007, the agency published the draft Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims that further outlined the FDA's approach to evaluating scientific evidence for health claims. In January 2009, the final guidance was posted and replaced the 1999 guidance document as well as the interim guidance related to qualified health claims. The final guidance specifically addresses the use of observational data in the evaluation of health claims and describes the criteria used by the agency in the evaluation of such data. A copy of the guidance can be found on the FDA Web site (http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm073332.htm). The guidance highlights some of the challenges that must be considered for the agency to use observational data to draw scientific conclusions on the relationship between a specific substance and disease or health-related condition for the health claim under review. This article is not subject to US copyright law.

Evaluating the Effect of Applying the FDA Definition of Whole Grains to Health Claims for Risk Reduction of Cardiovascular Disease and Diabetes

The U.S. Food and Drug Administration (FDA) defines whole grains as consisting of the intact, ground, cracked or flaked fruit of the grains whose principal components‐the starchy endosperm, germ and bran‐are present in the same relative proportions as they exist in the intact grain. We evaluated the effect of applying the FDA definition of whole grains on the strength of scientific evidence in support of claims for risk reduction of cardiovascular disease (CVD) and diabetes. We concluded that using the FDA definition for whole grains as a selection criterion is limiting because the majority of existing studies often use a broader meaning to define whole grains. When considering only whole grain studies that met the FDA definition we found insufficient scientific evidence to support a claim that whole grain intake reduces the risk of CVD. However, a whole grain and CVD health claim is supported when using a broader concept of whole grain to include studies that included intake of bran and germ as well as whole grain. The scientific evidence on the relationship of whole grain consumption and diabetes is suggestive but inconclusive whether or not the definition of whole grains was in accordance with that of the FDA. This type of analysis is complicated by variation among different types of whole grains due to their diversity in nutrients and bioactive components. This project was sponsored by Kellogg Company, USA.