Five aspects of research waste in biomedicine: A scoping review.

BACKGROUND: The number of published journal articles has grown exponentially during the last 30 years, which may have led to some wasteful research. However, the terminology associated with research waste remains unclear. To address this, we aimed to identify, define, and categorize the aspects of research waste in published biomedical reports. METHODS: In this scoping review, we systematically searched for biomedical literature reports from 1993 to 2023 in two databases, focusing on those addressing and defining research waste. Through data charting, we analyzed and categorized the aspects of research waste. RESULTS: Based on 4285 initial records in the searches, a total of 832 reports were included in the analysis. The included reports were primarily narrative reviews (26%) and original reports (21%). We categorized research waste into five aspects: methodological, invisible, negligible, underreported, and structural (MINUS) research waste. More than half of the reports (56%) covered methodological research waste concerning flaws in study design, study conduct, or analysis. Invisible research waste covered nonpublication, discontinuation, and lack of data-sharing. Negligible research waste primarily concerned unnecessary repetition, for example, stemming from the absence of preceding a trial with a systematic review of the literature. Underreported research waste mainly included poor reporting, resulting in a lack of transparency. Structural research waste comprised inadequate management, collaboration, prioritization, implementation, and dissemination. CONCLUSION: MINUS encapsulates the five main aspects of research waste. Recognizing these aspects of research waste is important for addressing and preventing further research waste and thereby ensuring efficient resource allocation and scientific integrity.

Enhancing the SUSTAINable uptake of evidence to minimise harms from alcohol and other drugs in New South Wales, Australia.

Although alcohol and other drug use is increasingly the focus of policy and research efforts, there are challenges identifying and applying evidence-based strategies to minimise harms for alcohol and other drugs in health care and community settings. These challenges include limited available research, variability across settings, and lack of 'fit' between research evidence and their intended settings. In this commentary, we describe a novel approach to develop and evaluate tailored, sustainable strategies to enhance the uptake of evidence-based activities into health services and community settings. Our approach involves four key principles: (i) identifying evidence-based alcohol and other drug harm minimisation strategies; (ii) partnering with local experts to identify and tailor strategies; (iii) implementing strategies into existing practice/infrastructure to build in sustainability; and (iv) using sustainable co-designed outcome measures including value-based health-care principles to measure uptake, feasibility and acceptability, health outcomes and economic implications. We propose that this approach offers a way forward to enhance the relevance and suitability of research in health services and community settings and has potential to be applied in other sectors.

A arte de elaborar uma pergunta de pesquisa / The art of crafting a research question

A criatividade na elaboração da pergunta impacta todo o processo da pesquisa, buscando suprir as lacuna do conhecimento, gerar percepções, instigar reflexões e procurar resolver problemas até então insolúveis. Objetivo: refletir acerca dos princípios fundamentais envolvidos na formulação de perguntas de pesquisa. Método: Estudo de crítico e reflexivo sobre tendências, lacunas e perspectivas emergentes contribuindo para uma compreensão mais aprofundada da complexidade envolvida na elaboração de perguntas de pesquisa. Resultados: emergiram duas categorias "Dimensões" e "Parâmetros" essenciais na elaboração da pergunta de pesquisa". Discussão: Acadêmicos e orientadores enfrentam dificuldades ao identificar elementos essenciais em uma pergunta de pesquisa estratégica e objetiva, denunciando a incerteza que provoca para a compreensão e investigação dos fenômenos. Deve ser sustentada por um paradigma de intelegibilidade, relação lógica e coerência epistemológica, subsidiando o autor na explcitação de sua voz. Conclusão: A habilidade de elaborar uma pergunta de pesquisa destaca a maestria do pesquisador, transcendendo a fronteira meramente linguistica.(AU)

Creativity in question formulation has an impact on the entire research process, seeking to fill knowledge gaps, generate insights, instigate reflections and try to solve previously unsolvable problems. Objective: To reflect on the fundamental principles involved in formulating research questions. Method: A critical and reflective study on emerging trends, gaps and perspectives, contributing to a deeper understanding of the complexity involved in formulating research questions. Results: Two categories emerged: "Dimensions" and "Parameters", which are essential when formulating a research question". Discussion: Academics and advisors face difficulties in identifying essential elements in a strategic and objective research question, denouncing the uncertainty it causes for understanding and investigating phenomena. It must be supported by a paradigm of intelegibility, logical relationship and epistemological coherence, supporting the author in explaining his or her voice. Conclusion: The ability to elaborate a research question highlights the mastery of the researcher, transcending the merely linguistic frontier.(AU)

La creatividad en la formulación de preguntas repercute en todo el proceso de investigación, al tratar de colmar lagunas de conocimiento, generar ideas, suscitar reflexiones y tratar de resolver problemas antes insolubles. Objetivo: Reflexionar sobre los principios fundamentales implicados en la formulación de preguntas de investigación. Método: Estudio crítico y reflexivo de las tendencias, lagunas y perspectivas emergentes, contribuyendo a una comprensión más profunda de la complejidad que entraña la formulación de preguntas de investigación. Resultados: Surgieron dos categorías: "Dimensiones" y "Parámetros" que son esenciales a la hora de diseñar una pregunta de investigación". Discusión: Académicos y orientadores enfrentan dificultades para identificar los elementos esenciales en una pregunta de investigación estratégica y objetiva, denunciando la incertidumbre que provoca para la comprensión e investigación de los fenómenos. Debe apoyarse en un paradigma de intelegibilidad, relación lógica y coherencia epistemológica, ayudando al autor a explicitar su voz. Conclusión: La capacidad de elaborar una pregunta de investigación destaca el dominio del investigador, trascendiendo la frontera meramente lingüística. (AU)

Impact of harm minimization interventions on reducing blood-borne infection transmission and some injecting behaviors among people who inject drugs: an overview and evidence gap mapping.

BACKGROUND: This study aimed to synthetize the evidence on the effectiveness of harm minimization interventions on reducing blood-borne infection transmission and injecting behaviors among people who inject drugs (PWID) through a comprehensive overview of systematic reviews and evidence gap mapping. METHODS: A systematic review was conducted with searches in PubMed and Scopus to identify systematic reviews assessing the impact of interventions aimed at reducing the harms associated with injectable drug use. The overall characteristics of the studies were extracted and their methodological quality was assessed using AMSTAR-2. An evidence gap map was constructed, highlighting the most frequently reported outcomes by intervention (CRD42023387713). RESULTS: Thirty-three systematic reviews were included. Of these, 14 (42.2%) assessed the impact of needle/syringe exchange programs (NSEP) and 11 (33.3%) examined opioid agonist therapy (OAT). These interventions are likely to be associated with reductions of HIV/HCV incidence (10-40% risk reduction for NSEP; 50-60% for OAT) and sharing injecting paraphernalia (50% for NSEP, 25-85% for OAT), particularly when combined (moderate evidence). Behavioral/educational interventions were assessed in 12 reviews (36.4%) with most authors in favor/partially in favor of the use of these approaches (moderate evidence). Take-home naloxone programs and supervised-injection facilities were each assessed in two studies (6.1%), which reported inconclusive results (limited/inconsistent evidence). Most authors reported high levels of heterogeneity and risk of bias. Other interventions and outcomes were inadequately reported. Most systematic reviews presented low or critically low quality. CONCLUSION: The evidence is sufficient to support the effectiveness of OAT, NSEP and their combination in reducing blood-borne infection transmission and certain injecting behaviors among PWID. However, evidence of other harm minimizations interventions in different settings and for some outcomes remain insufficient.

Utilization of innovative medical technologies in German inpatient care: does evidence matter?

BACKGROUND: The reimbursement of new technologies in inpatient care is not always linked to a requirement for evidence-based evaluation of patient benefit. In Germany, every new technology approved for market was until recently eligible for reimbursement in inpatient care unless explicitly excluded. The aim of this work was (1) to investigate the type of evidence that was available at the time of introduction of 25 innovative technologies and how this evidence evolved over time, and (2) to explore the relationship between clinical evidence and utilization for these technologies in German inpatient care. METHODS: This study combined different methods. A systematic search for evidence published between 2003 and 2017 was conducted in four bibliographic databases, clinical trial registries, resources for clinical guidelines, and health technology assessment-databases. Information was also collected on funding mechanisms and safety notices. Utilization was measured by hospital procedures captured in claims data. The body of evidence, funding and safety notices per technology were analyzed descriptively. The relationship between utilization and evidence was explored empirically using a multilevel regression analysis. RESULTS: The number of included publications per technology ranges from two to 498. For all technologies, non-comparative studies form the bulk of the evidence. The number of randomized controlled clinical trials per technology ranges from zero to 19. Some technologies were utilized for several years without an adequate evidence base. A relationship between evidence and utilization could be shown for several but not all technologies. CONCLUSIONS: This study reveals a mixed picture regarding the evidence available for new technologies, and the relationship between the development of evidence and the use of technologies over time. Although the influence of funding and safety notices requires further investigation, these results re-emphasize the need for strengthening market approval standards and HTA pathways as well as approaches such as coverage with evidence development.

Evidence gaps in orthognathic surgery, a Delphi study protocol

Aim: To assess the research gaps identified in a recent mapping review of orthognathic surgery through their evaluation by clinical experts, leading to a clinically relevant list of research gaps. This will guide future investigations of the topic, focusing on the outcomes of blood loss, infection, and relapse. Methods: The Delphi technique will be used to appraise the identified research gaps. The expert panel will include maxillofacial surgeons who regularly perform orthognathic surgery. Potential participants will be identified through various methods, including contact information from articles in the mapping review, nominations from peers, and social media platforms. Two rounds of surveys will be undertaken with Likert-type and open-ended questions to assess the clinical relevance of research gaps. For the second round, participants will receive a report of the results of the first round. Questions will be modified depending on the answers obtained in the first round. A consensus of 60% will be considered valid. Conclusions: Through this Delphi study, in a collaborative effort between researchers and clinical experts, a comprehensive understanding of the clinical relevance of research gaps in orthognathic surgery will be achieved. The outcomes will guide future investigations, ultimately improving the outcomes and practices in this field.

An evidence-base for the implementation of hospital-based palliative care programs in routine cancer practice: A systematic review.

BACKGROUND: Despite global support, there remain gaps in the integration of early palliative care into cancer care. The methods of implementation whereby evidence of benefits of palliative care is translated into practice deserve attention. AIM: To identify implementation frameworks utilised in integrated palliative care in hospital-based oncology services and to describe the associated enablers and barriers to service integration. DESIGN: Systematic review with a narrative synthesis including qualitative, mixed methods, pre-post and quasi experimental designs following the guidance by the Centre for Reviews and Dissemination (PROSPERO registration CRD42021252092). DATA SOURCES: Six databases searched in 2021: EMBASE, EMCARE, APA PsycINFO, CINAHL, Cochrane Library and Ovid MEDLINE searched in 2023. Included were qualitative or quantitative studies, in English language, involving adults >18 years, and implementing hospital-based palliative care into cancer care. Critical appraisal tools were used to assess the quality and rigour. RESULTS: Seven of the 16 studies explicitly cited the use of frameworks including those based on RE-AIM, Medical Research Council evaluation of complex interventions and WHO constructs of health service evaluation. Enablers included an existing supportive culture, clear introduction to the programme across services, adequate funding, human resources and identification of advocates. Barriers included a lack of communication with the patients, caregivers, physicians and palliative care team about programme goals, stigma around the term 'palliative', a lack of robust training, or awareness of guidelines and undefined staff roles. CONCLUSIONS: Implementation science frameworks provide a method to underpin programme development and evaluation as palliative care is integrated within the oncology setting.

Gaps in the evidence underpinning high-risk medical devices in Europe at market entry, and potential solutions.

AIM: To determine the level of evidence for innovative high-risk medical devices at market entry. METHODS: We reviewed all Belgian healthcare payer (RIZIV-INAMI) assessor reports on novel implants or invasive medical devices (n = 18, Class IIb-III) available between 2018 to mid-2019 on applications submitted for inclusion on their reimbursement list. We also conducted a review of the literature on evidence gaps and an analysis of relevant legal and ethical frameworks within the European context. FINDINGS: Conformity assessment of medical devices is based on performance, safety, and an acceptable risk-benefit balance. Information submitted for obtaining CE marking is confidential and legally protected, limiting access to clinical evidence. Seven out of the 18 RIZIV-INAMI assessor reports (39%) included a randomized controlled trial (RCT) using the novel device, whilst 2 applications (11%) referred to an RCT that used a different device. The population included was inappropriate or unclear for 3 devices (17%). Only half of the applications presented evidence on quality of life or functioning and 2 (11%) presented overall survival data. Four applications (22%) included no data beyond twelve months. The findings from the literature demonstrated similar problems with the study design and the clinical evidence. DISCUSSION AND CONCLUSIONS: CE marking does not indicate that a device is effective, only that it complies with the law. The lack of transparency hampers evidence-based decision making. Despite greater emphasis on clinical benefit for the patient, the provisions of the European Medical Device Regulation (MDR) are not yet fully aligned with international ethical standards for clinical research. The MDR fails to address key issues, such as the lack of access to data submitted for CE marking and a failure to require evidence of clinical effectiveness. Indeed, a first report shows no improvement in the clinical evidence for implantable devices generated under the MDR. Thus, patients may continue to be exposed to ineffective or unsafe novel devices. The Health Technology Assessment Regulation plans for Joint Scientific Consultations for specific high-risk devices before companies begin their pivotal clinical investigations. The demanded comparative evidence should facilitate payer decisions. Nevertheless, there is also a need for legislation requiring comparative RCTs assessing patient-relevant outcomes for high-risk devices to ensure implementation, including development and implementation of common specifications for study designs.

Conservative treatment for iliotibial band syndrome: Are we facing a research gap? A scoping review of 98 studies with clinical perspectives.

OBJECTIVES: To identify which treatment modalities are described in the literature for the conservative management of ITBS (1) and to identify research gap (2). DATABASES: The following electronic databases were searched: MEDLINE/Pubmed, Embase, Scopus and Cochrane Library. ELIGIBILITY CRITERIA: The included studies had to report at least one conservative treatment on a human population suffering from ITBS. RESULTS: 98 studies reached the included criteria and seven categories of treatment were identified, i.e., stretching, adjuvants, physical modalities, injections, strengthening, manual techniques and education. Only 32 studies were designed as original clinical studies within which only 7 were randomized controlled trials, while 66 were review studies. Education, injections and medications as well as stretching were the most cited therapies. However, there was a clear discrepancy design. For example, stretching modalities were reported in 31% and 78% for clinical and review studies, respectively. CONCLUSIONS: There is an objective research gap in the literature concerning conservative ITBS management. The recommendations are mostly based on expert opinions and review article. More high-quality research studies should be performed for enhancing the ITBS conservative management understanding.

Research evidence and implementation gaps in the engagement of people with lived experience in mental health and substance use research: a scoping review.

BACKGROUND: There is growing recognition that engaging people with lived experience (PWLE) in mental health and substance use research improves the quality of the research in terms of relevance to the population and the feasibility of the work. Engagement also provides positive opportunities for research teams and the PWLE engaged. However, there are many gaps in the research on PWLE engagement. This scoping review synthesizes the gaps in the implementation of PWLE engagement and in the research on engagement as presented by research teams engaging PWLE in their work. METHOD: A systematic electronic database search was conducted in 2022 for published articles on PWLE engagement in mental health and substance use research. Potential articles were screened for relevance. The search led to 49 final articles included in the review. The 49 articles were then coded using codebook thematic analysis to answer two research questions: (1) What are the research evidence gaps regarding the engagement of PWLE in mental health and substance use research?; and (2) What are the gaps in implementing PWLE engagement in mental health and substance use research? PWLE were engaged in the conduct of this review. RESULTS: Results showed that research evidence gaps include further work on conceptualizing engagement; developing resources, tools, and practice recommendations to support research teams; increasing diversity in evaluations of engagement; and evaluating engagement, including its impact on the research, on PWLE, and on researchers. Implementation gaps included several broader institutional gaps and gaps in the day-to-day practice of engagement. CONCLUSIONS: Despite progress in PWLE engagement in mental health and substance use research in recent years, research evidence and implementation gaps remain. Research teams are encouraged to consider these gaps and conduct research and implementation activities to address them in a rigorous manner.

There is growing recognition that engaging people with lived experience (PWLE) in mental health and substance use research improves the quality of the research by making it more relevant to the population and more feasible. Engagement also provides positive opportunities for those working in this way. However, many questions remain unanswered in terms of PWLE engagement. We reviewed the published literature to identify gaps in the research on PWLE engagement and on the ways PWLE engagement is practiced in mental health and substance use research. We identified 49 articles addressing these issues. We examined each article to identify (1) research evidence gaps regarding the engagement of PWLE in mental health and substance use research; and (2) gaps in the way PWLE engagement is put into place in mental health and substance use research. We found that research evidence gaps include the need for further research work to understand what engagement and lived experience are; the need to develop resources, tools, and practice recommendations to support PWLE engagement; the need to increase the diversity of the PWLE engaged; and the need to evaluate the impact of engagement on the research, on PWLE, and on researchers. Gaps in the practice of PWLE engagement included several broader institutional gaps and gaps in the day-to-day practice. Despite progress in PWLE engagement in research in recent years, many gaps remain. Research teams are encouraged to conduct research to clarify these aspects of engagement and to implement engagement in ways that address these gaps.

Sensory processing and engagement: a systematic review / Processamento sensorial e engajamento: uma revisão sistemática

Abstract The ability of children to organize themselves sensorially in a school environment to remain engaged in their routine activities has been minimally explored by occupational therapists. This study aimed to identify research on sensory processing and engagement carried out by occupational therapists over the past decade. Moreover, it seeks to analyze the depth and quality of discussions regarding the relationship between sensory processing and children's engagement in their occupations. A systematic review was conducted utilizing the descriptors: sensory processing, engagement, and occupational therapy. These descriptors were combined through the AND operator in the VHL, PubMed, and Web of Science databases. Included articles, whether in English or other languages, defined and measured sensory processing; highlighted a relationship between child sensory processing and occupational engagement; were published within the past 10 years (2008 to 2018); underwent peer-review; are available in full; involved participants aged 0 to 7 years; and were authored by occupational therapists. The review process was performed by two authors using predefined data fields, which included study quality indicators. The results identified a mere nine articles on this specific theme. An assessment based on the OT Seeker scale revealed scores of moderate magnitude. This suggests a pressing need for occupational therapists to invest in the expansion of discerning research, aiming to elevate scientific evidence regarding the relationship between sensory processing and occupational engagement.

Resumo A capacidade das crianças de se organizarem sensorialmente em ambiente escolar para se manterem engajadas em suas atividades rotineiras tem sido pouco explorada por terapeutas ocupacionais. Este estudo teve como objetivo identificar pesquisas sobre processamento sensorial e engajamento realizadas por terapeutas ocupacionais na última década, bem como avaliar a qualidade das discussões sobre a relação entre processamento sensorial e engajamento de crianças em suas ocupações. Trata-se de uma revisão sistemática realizada a partir da busca dos descritores: processamento sensorial, engajamento e terapia ocupacional, combinados segundo o operador AND, nas plataformas BVS, PubMed e Web of Science. Os artigos incluídos, tanto em inglês e como em outras línguas, definiram e mediram processamento sensorial; apontaram relação entre processamento sensorial e engajamento ocupacional infantil; foram publicados nos últimos 10 anos (de 2008 a 2018); revisados ​​por pares; estão disponíveis na íntegra; envolveram participantes com idade entre 0 e 7 anos, e foram escritos por terapeutas ocupacionais. As revisões foram realizadas por duas autoras usando campos de dados predefinidos, incluindo indicadores de qualidade do estudo. Os resultados identificaram apenas nove artigos sobre esse tema específico. A análise da classificação, com base na escala OT Seeker, revelou escores de magnitude moderada, o que sugere a necessidade de terapeutas ocupacionais investirem na ampliação de pesquisas criteriosas a fim de aumentar os níveis de evidência científica sobre a relação entre processamento sensorial e engajamento ocupacional.

Evidence Gaps in Clinical Trials of Pharmacologic Treatment for H1-Antihistamine-Refractory Chronic Spontaneous Urticaria: A Systematic Review and Future Perspectives.

No data addressing issues concerning disparities in participant and trial characteristics and trial outcome reporting have been established in clinical trials for H1-antihistamine-refractory chronic spontaneous urticaria (CSU). To better harmonize and compare the different treatment interventions, we systematically evaluated the overall landscape of pharmacological treatments for H1-antihistamine-refractory CSU clinical trials published between 2000 and 2021. This systematic review included 23 randomized clinical trials involving 2480 participants from 22 countries. We found significant increases in the number of globally published and newly tested drugs, especially biologic drugs. Regarding relatively small trials, we found that people living with H1-antihistamine-refractory CSU who were identified as members of minority groups (non-white population), populations of regions other than North America/Europe, and populations of low- to lower/upper-middle-income countries are underrepresented. Most trials were designed to evaluate treatment efficacy and safety profiles; however, less than half of the included trials reported the patient's perspective in terms of patient-reported outcomes. Disparities in outcome reporting, including clinimetric tools for assessing treatment response and outcome sets, were observed. To close the evidence gap in H1-antihistamine-refractory CSU trials, strategies for improving trial and participant enrollment and standardizing core outcome sets for trial reporting are needed.

Postlaunch evidence generation practices among health technology assessment bodies in Europe.

OBJECTIVES: The term Postlaunch Evidence Generation (PLEG) refers to evidence generated after the launch or licensing of a health technology. The aim of this paper is to provide an overview of the implementation of these practices in the European Union in order to explore cross-border cooperation opportunities. METHODS: In December 2019, a survey composed of nine closed-ended questions with multiple choice answers about the PLEG practices in each country was sent to all twenty-five dedicated work package (WP5B) partners of the European Network of Health Technology Assessment (EUnetHTA) Joint Action 3. In addition to the survey, the national practices were discussed during a face-to-face meeting with WP5B partners. RESULTS: Twelve Health TechnologyAssessment (HTA) bodies completed the survey. Of these, eleven reported procedures in place for official requests for PLEGs in their remit. In the large majority of cases, the requests are made at the time of the assessment/appraisal. Several agencies participate in the definition of the scope of the PLEG or review of its protocol. Data collection and analysis mainly lie with companies for pharmaceuticals, whereas it is more the responsibility of the HTA bodies for medical devices. Only one agency owns the data and is able to exchange them without asking permission. CONCLUSIONS: Most agencies recommend European collaboration on PLEG commence once the evidence gaps have been defined or during the production of the HTA report in the case of European joint assessment.

Further evidence needed to change policy for the safe and effective radical cure of vivax malaria: Insights from the 2019 annual APMEN Vivax Working Group meeting.

New diagnostics and treatment options for the radical cure of Plasmodium vivax malaria are now available. At the 2019 annual meeting of the Vivax Working Group of the Asia Pacific Malaria Elimination Network, participants took part in a roundtable discussion to identify further evidence required to introduce these new tools into policy and practice. Key gaps identified were accuracy and reliability of glucose-6-phosphate-dehydrogenase deficiency tests, health system capacity, and feasibility and cost effectiveness of novel treatment strategies in routine clinical practice. As expected, there were differences in the priorities between country partners and researcher partners. To achieve the 2030 target for the regional elimination of malaria, evidence to address these issues should be generated as a matter of priority. Review of global guidelines alongside locally generated data will help to ensure the timely revision and optimisation of national treatment guidelines that will be vital to meet regional elimination goals.

A scoping review of racial/ethnic disparities in sleep.

BACKGROUND: Despite remarkable achievements in ensuring health equity, racial/ethnic disparities in sleep still persist and are emerging as a major area of concern. Accumulating evidence has not yet been well characterized from a broad perspective. We conducted a scoping review of studies on sleep disparities by race/ethnicity to summarize characteristics of existing studies and identify evidence gaps. METHODS: We searched PubMed, CINAHL, PsycINFO, and Web of Science databases for studies of racial/ethnic disparities in sleep. Studies that met inclusion criteria were retrieved and organized in a data charting form by study design, sleep measuring methods, sleep features, and racial/ethnic comparisons. RESULTS: One hundred sixteen studies were included in this review. Most studies focused on disparities between Whites and Blacks. Disproportionately fewer studies examined disparities for Hispanic, Asian, and other racial/ethnic groups. Self-reported sleep was most frequently used. Sleep duration, overall sleep quality, and sleep disordered breathing were frequently studied, whereas other features including sleep efficiency, latency, continuity, and architecture were understudied, particularly in racial minority groups in the US. Current study findings on racial/ethnic disparities in most of sleep features is mixed and inconclusive. CONCLUSIONS: This review identified significant evidence gaps in racial/ethnic disparities research on sleep. Our results suggest a need for more studies examining diverse sleep features using standardized and robust measuring methods for more valid comparisons of sleep health in diverse race/ethnicity groups.

GRADE notes: How to use GRADE when there is "no" evidence? A case study of the expert evidence approach.

OBJECTIVES: One essential requirement of trustworthy guidelines is that they should be based on systematic reviews of the best available evidence. The GRADE Working Group has provided guidance for evaluating the certainty of evidence based on several domains. However, for many clinical questions, published evidence may be limited, too indirect or simply not exist. In this brief report (GRADE notes), we describe our method of developing evidence-based recommendations when publisheddirect evidence was lacking. STUDY DESIGN AND SETTING: When direct published literature was absent, an expert evidence survey was administered to panel members about their unpublished observations and case series. Focus was on collecting data about cases and outcome, not panel opinions. RESULTS: Out of 26 questions prioritized by the panel for pediatric venous thromboembolism, 12 had no, very limited, or very low certainty of evidence to inform them. The panel survey was administered for these questions. CONCLUSIONS: Areas of sparse evidence often reflect key questions that are critical to address in clinical practice guidelines due to the uncertainty among health care providers. The expert evidence approach used in this study is one method for panels totransparently deal with the lack of published evidence to directly inform recommendations.

Aortic Stenosis: Guidelines and Evidence Gaps.

Current guidelines for management of adults with aortic stenosis recommend aortic valve replacement for patients with clinical consequences due to hemodynamically severe valve obstruction. However, advances in surgical and transcatheter techniques, and improved valve design have led to decreased procedural risk and improved long-term outcomes. Transcatheter aortic valve replacement (TAVR) is recommended for patients with prohibitive surgical risk and is reasonable in intermediate and high-risk patients. Recent trials demonstrated favorable short-term outcomes in patients with low surgical risk undergoing TAVR compared with surgical AVR. We review the current Guidelines recommendations and highlight key controversies in management due to evidence gaps.

Evidence and evidence gaps in the treatment of Eustachian tube dysfunction and otitis media.

Evidence-based medicine is an approach to medical treatment intended to optimize patient-oriented decision-making on the basis of empirically proven effectiveness. For this purpose, a classification system has been established to categorize studies - and hence therapy options - in respect of associated evidence according to defined criteria. The Eustachian tube connects the nasopharynx with the middle ear cavity. Its key function is to ensure middle ear ventilation. Compromised ventilation results in inflammatory middle ear disorders. Numerous evidence-based therapy options are available for the treatment of impaired middle ear ventilation and otitis media, the main therapeutic approach being antibiotic treatment. More recent procedures such as balloon dilation of the Eustachian tube have also shown initial success but must undergo further evaluation with regard to evidence. There is, as yet, no evidence for some of the other long-established procedures. Owing to the multitude of variables, the classification of evidence levels for various treatment approaches calls for highly diversified assessment. Numerous evidence-based studies are therefore necessary in order to evaluate the evidence pertaining to existing and future therapy solutions for impaired middle ear ventilation and otitis media. If this need is addressed, a wealth of implications can be expected for therapeutic approaches in the years to come.

Evidence and evidence gaps in therapies of nasal obstruction and rhinosinusitis.

Therapeutic decisions in otorhinolaryngology are based on clinical experience, surgical skills, and scientific evidence. Recently, evidence-based therapies have gained increased attention and importance due to their potential to improve the individual patient's treatment and their potential at the same time to reduce treatment costs. In clinical practice, it is almost impossible to stay ahead of the increasing mass of literature and on the other hand critically assess the presented data. A solid scientific and statistical knowledge as well as a significant amount of spare time are required to detect systematic bias and other errors in study designs, also with respect to assessing whether or not a study should be part of an individual therapeutic decision. Meta-analyses, reviews, and clinical guidelines are, therefore, of increasing importance for evidence-based therapy in clinical practice. This review is an update of the availability of external evidence for the treatment of nasal obstruction and rhinosinusitis. It becomes evident that both groups of diseases differ significantly in the availability of external evidence. Furthermore, it becomes obvious that surgical treatment options are normally based on evidence of significantly lower quality than medical treatment options.