Use of Nonmedicated Control Substances in Randomized Clinical Trials of Patients with Chronic Rhinosinusitis:A Systematic Review and Single-Arm Meta-analysis

IMPORTANCE: The effect of nonmedicated control substances in chronic rhinosinusitis remains unclear. OBJECTIVE: To assess the association of nonmedicated control substances in randomized clinical trials with disease outcomes in patients diagnosed with chronic rhinosinusitis. DATA SOURCES AND STUDY SELECTION: In this single-arm systematic review and meta-analysis, the Cochrane Library of Systematic Reviews, Ovid MEDLINE, Embase, PubMed, and ClinicalTrials.gov databases were searched for randomized clinical trials with a preintervention and postintervention design for chronic rhinosinusitis that were published between 1946 and January 23, 2019. DATA EXTRACTION AND SYNTHESIS: Paired reviewers independently extracted data. The analyses used random-effects models and the Cochrane risk of bias assessment to rate the quality of the evidence. MAIN OUTCOMES AND MEASURES: The primary outcomes were the association of nonmedicated control substances with 22-item Sinonasal Outcome Test (SNOT-22) scores or nasal symptom scores when SNOT-22 was not available. RESULTS: A total of 2305 abstracts were identified and screened, 725 articles were reviewed in full text, and 38 articles met the study criteria and were included in the meta-analysis. Among the 38 included studies, a total of 2258 adults (mean age range, 27-53 years; 20.0%-72.5% women) were randomized to receive nonmedicated control substances or sham interventions. Topical nonmedicated control substances were associated with significant reduction in SNOT-22 scores (mean difference [MD], −8.81; 95% CI, −12.60 to −5.03). A subgroup analysis of topical therapies, limited to saline irrigation and nasal spray diluents, found that topical diluents were associated with a greater reduction in SNOT-22 scores (MD, −11.45; 95% CI, −13.50 to −9.41) compared with saline irrigation (MD, −13.60; 95% CI, −19.95 to −7.25). Nonmedicated control substances were associated with a significant reduction in nasal obstruction scores (standardized MD [SMD], −0.42; 95% CI, −0.81 to −0.03). No significant change was found in rhinorrhea scores (SMD, −0.34; 95% CI, −1.37 to 0.69), postnasal drip scores (SMD, −0.96; 95% CI, −2.18 to 0.25), facial pain scores (SMD, −0.57; 95% CI, −1.68 to 0.55), or loss of smell scores (SMD, −0.18; 95% CI, −0.68 to 0.32). CONCLUSIONS AND RELEVANCE: This systematic review and meta-analysis of the use of nonmedicated control substances in randomized clinical trials of chronic rhinosinusitis outcomes suggests that the use of nonmedicated control substances is associated with limited improvements in SNOT-22 and nasal obstruction scores. These findings highlight potential areas of future research directions and the importance of randomized clinical trials to accurately estimate treatment effect

Perioperative nasal and paranasal sinus considerations in transsphenoidal surgery for pituitary disease

Endoscopic endonasal skull base surgery has emerged as the treatment modality of choice for a range of skull base lesions, particularly pituitary adenomas. However, navigation and manipulation of the nasal corridor and paranasal sinuses requires that surgeons are aware of effective techniques to maximize patient outcomes and avoid sinonasal morbidity postoperatively. This paper is a narrative review aimed to provide an updated and consolidated report on the perioperative management of the nasal corridor and paranasal sinuses in the setting of endoscopic skull base surgery for pituitary disease. Anatomic variants and common surgical techniques are discussed. Post-operative complications are evaluated in detail. Understanding the structural implications of the endonasal approach to the sphenoid is crucial to opti

From complexity to clarity:how directed acyclic graphs enhance the study design of systematic reviews and meta-analyses

While frameworks to systematically assess bias in systematic reviews and meta-analyses (SRMAs) and frameworks on causal inference are well established, they are less frequently integrated beyond the data analysis stages. This paper proposes the use of Directed Acyclic Graphs (DAGs) in the design stage of SRMAs. We hypothesize that DAGs created and registered a priori can offer a useful approach to more effective and efficient evidence synthesis. DAGs provide a visual representation of the complex assumed relationships between variables within and beyond individual studies prior to data analysis, facilitating discussion among researchers, guiding data analysis, and may lead to more targeted inclusion criteria or set of data extraction items. We illustrate this argument through both experimental and observational case examples.</p

Global mapping of randomised trials related articles published in high-impact-factor medical journals: a cross-sectional analysis

BACKGROUND: Randomised controlled trials (RCTs) provide the most reliable information to inform clinical practice and patient care. We aimed to map global clinical research publication activity through RCT-related articles in high-impact-factor medical journals over the past five decades. METHODS: We conducted a cross-sectional analysis of articles published in the highest ranked medical journals with an impact factor > 10 (according to Journal Citation Reports published in 2017). We searched PubMed/MEDLINE (from inception to December 31, 2017) for all RCT-related articles (e.g. primary RCTs, secondary analyses and methodology papers) published in high-impact-factor medical journals. For each included article, raw metadata were abstracted from the Web of Science. A process of standardization was conducted to unify the different terms and grammatical variants and to remove typographical, transcription and/or indexing errors. Descriptive analyses were conducted (including the number of articles, citations, most prolific authors, countries, journals, funding sources and keywords). Network analyses of collaborations between countries and co-words are presented. RESULTS: We included 39,305 articles (for the period 1965-2017) published in forty journals. The Lancet (n = 3593; 9.1%), the Journal of Clinical Oncology (n = 3343; 8.5%) and The New England Journal of Medicine (n = 3275 articles; 8.3%) published the largest number of RCTs. A total of 154 countries were involved in the production of articles. The global productivity ranking was led by the United States (n = 18,393 articles), followed by the United Kingdom (n = 8028 articles), Canada (n = 4548 articles) and Germany (n = 4415 articles). Seventeen authors who had published 100 or more articles were identified; the most prolific authors were affiliated with Duke University (United States), Harvard University (United States) and McMaster University (Canada). The main funding institutions were the National Institutes of Health (United States), Hoffmann-La Roche (Switzerland), Pfizer (United States), Merck Sharp & Dohme (United States) and Novartis (Switzerland). The 100 most cited RCTs were published in nine journals, led by The New England Journal of Medicine (n = 78 articles), The Lancet (n = 9 articles) and JAMA (n = 7 articles). These landmark contributions focuse

Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) Statement: Updated Reporting Guidance for Health Economic Evaluations.

Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, and the increased role of stakeholder involvement, including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as healthcare, public health, education, social care, etc.). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer-reviewed journals as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making

Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) Statement: Updated Reporting Guidance for Health Economic Evaluations.

Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, as well as the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as health care, public health, education, social care, etc). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer reviewed journals as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making

Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 Explanation and Elaboration: A Report of the ISPOR CHEERS II Good Practices Task Force.

Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces the previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, and the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as healthcare, public health, education, and social care). This Explanation and Elaboration Report presents the new CHEERS 2022 28-item checklist with recommendations and explanation and examples for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer-reviewed journals and the peer reviewers and editors assessing them for publication. Nevertheless, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, given that there is an increasing emphasis on transparency in decision making

Consolidated health economic evaluation reporting standards 2022 (CHEERS 2022) statement : updated reporting guidance for health economic evaluations

Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, as well as the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as health care, public health, education, social care, etc). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer reviewed journals as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making

Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement : updated reporting guidance for health economic evaluations

Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, as well as the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as health care, public health, education, social care, etc). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer reviewed journals as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making