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1.
Ann Rheum Dis ; 2024 Jan 11.
Artigo em Inglês | MEDLINE | ID: mdl-38212040

RESUMO

INTRODUCTION: Hip and knee osteoarthritis (OA) are increasingly common with a significant impact on individuals and society. Non-pharmacological treatments are considered essential to reduce pain and improve function and quality of life. EULAR recommendations for the non-pharmacological core management of hip and knee OA were published in 2013. Given the large number of subsequent studies, an update is needed. METHODS: The Standardised Operating Procedures for EULAR recommendations were followed. A multidisciplinary Task Force with 25 members representing 14 European countries was established. The Task Force agreed on an updated search strategy of 11 research questions. The systematic literature review encompassed dates from 1 January 2012 to 27 May 2022. Retrieved evidence was discussed, updated recommendations were formulated, and research and educational agendas were developed. RESULTS: The revised recommendations include two overarching principles and eight evidence-based recommendations including (1) an individualised, multicomponent management plan; (2) information, education and self-management; (3) exercise with adequate tailoring of dosage and progression; (4) mode of exercise delivery; (5) maintenance of healthy weight and weight loss; (6) footwear, walking aids and assistive devices; (7) work-related advice and (8) behaviour change techniques to improve lifestyle. The mean level of agreement on the recommendations ranged between 9.2 and 9.8 (0-10 scale, 10=total agreement). The research agenda highlighted areas related to these interventions including adherence, uptake and impact on work. CONCLUSIONS: The 2023 updated recommendations were formulated based on research evidence and expert opinion to guide the optimal management of hip and knee OA.

3.
Syst Rev ; 12(1): 234, 2023 12 14.
Artigo em Inglês | MEDLINE | ID: mdl-38098085

RESUMO

BACKGROUND: As systematic reviews (SRs) inform healthcare decisions, it is key that they address relevant questions and use rigorous methodology. Registration of SR protocols helps researchers identify relevant topics for future reviews and aims to prevent bias and duplication of effort. However, most SRs protocols are currently not registered, despite its significance. To guide future recommendations to enhance preregistration of SRs, it is important to gain a comprehensive understanding of the perspectives within the research community. Therefore, this study aims to examine the experiences with and factors of influence (barriers and facilitators) on prospective SR registration amongst researchers, peer reviewers and journal editors. METHODS: Two different surveys were distributed to two groups: researchers and journal editors both identified from an existing sample of SRs. Researchers who indicated to have peer reviewed a SR were surveyed on their perspectives as peer reviewers as well. Survey design and analysis were informed by the Consolidated Framework for Implementation Research (CFIR). Shared and unique subthemes from the perspectives of researchers, peer reviewers and journal editors were identified and linked to the SR registration process (Innovation), to team, organisation (Inner setting) and (inter)national research community (Outer setting), and to characteristics of researchers, peer reviewers or journal editors (Individuals). RESULTS: The survey's response rates were 65/727 (9%) for researchers, of which 37 were peer reviewers, and 22/308 (7%) for journal editors. Most respondents (n = 76, 94%) were familiar with SR protocol registration and 81% of researchers had registered minimally one SR protocol. Shared SR registration process subthemes were the importance and advantages of SR protocol registration, as well as barriers such as a high administrative burden. Shared subthemes regarding the inner and outer setting centred on journal processes, external standards and time. Shared individual factors were knowledge, skills and awareness. CONCLUSIONS: The majority of the respondents were familiar with SR protocol registration and had a positive attitude towards it. This study identified suboptimal registration process, administrative burden and lack of mandatory SR protocol registration as barriers. By overcoming these barriers, SR protocol registration could contribute more effectively to the goals of open science. SYSTEMATIC REVIEW REGISTRATION: osf.io/gmv6z.


Assuntos
Revisões Sistemáticas como Assunto , Humanos , Inquéritos e Questionários , Publicações
4.
Syst Rev ; 12(1): 63, 2023 04 04.
Artigo em Inglês | MEDLINE | ID: mdl-37016459

RESUMO

BACKGROUND: Along with other types of research, it has been stated that the extent of redundancy in systematic reviews has reached epidemic proportions. However, it was also emphasized that not all duplication is bad, that replication in research is essential, and that it can help discover unfortunate behaviors of scientists. Thus, the question is how to define a redundant systematic review, the harmful consequences of such reviews, and what we could do to prevent the unnecessary amount of this redundancy. MAIN BODY: There is no consensus definition of a redundant systematic review. Also, it needs to be defined what amount of overlap between systematic reviews is acceptable and not considered a redundancy. One needs to be aware that it is possible that the authors did not intend to create a redundant systematic review. A new review on an existing topic, which is not an update, is likely justified only when it can be shown that the previous review was inadequate, for example, due to suboptimal methodology. Redundant meta-analyses could have scientific, ethical, and economic questions for researchers and publishers, and thus, they should be avoided, if possible. Potential solutions for preventing redundant reviews include the following: (1) mandatory prospective registration of systematic reviews; (2) editors and peer reviewers rejecting duplicate/redundant and inadequate reviews; (3) modifying the reporting checklists for systematic reviews; (4) developing methods for evidence-based research (EBR) monitoring; (5) defining systematic reviews; (6) defining the conclusiveness of systematic reviews; (7) exploring interventions for the adoption of methodological advances; (8) killing off zombie reviews (i.e., abandoned registered reviews); (9) better prevention of duplicate reviews at the point of registration; (10) developing living systematic reviews; and (11) education of researchers. CONCLUSIONS: Disproportionate redundancy of the same or very similar systematic reviews can lead to scientific, ethical, economic, and societal harms. While it is not realistic to expect that the creation of redundant systematic reviews can be completely prevented, some preventive measures could be tested and implemented to try to reduce the problem. Further methodological research and development in this field will be welcome.


Assuntos
Revisões Sistemáticas como Assunto , Humanos , Estudos Prospectivos
5.
JAMA Netw Open ; 6(3): e234219, 2023 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-36951864

RESUMO

Importance: Systematic reviews can help to justify a new randomized clinical trial (RCT), inform its design, and interpret its results in the context of prior evidence. Objective: To assess trends and factors associated with citing (a marker of the use of) prior systematic reviews in RCT reports. Design, Setting, and Participants: This cross-sectional study investigated 737 Cochrane reviews assessing health interventions to identify 4003 eligible RCTs, defined as those included in an updated version but not in the first version of a Cochrane review and published 2 years after the first version of the Cochrane review was published. Main Outcomes and Measures: The primary outcome was the citation of prior systematic reviews, Cochrane or others, as determined by screening references of eligible RCTs. Factors that may be associated with the citation of prior systematic reviews were also examined. Results: Among 4003 eligible RCTs, 1241 studies (31.0%) cited Cochrane reviews, 1698 studies (42.4%) cited prior non-Cochrane reviews, and 2265 studies (56.6%) cited either type of systematic review or both; 1738 RCTs (43.4%) cited no systematic reviews. The percentage of RCTs citing prior Cochrane reviews, non-Cochrane reviews, and either or both types of review increased from 28 studies (15.3%), 46 studies (25.1%), and 65 studies (35.5%) of 183 RCTs before 2008 to 42 studies (40.8%), 65 studies (64.1%), and 73 studies (71.8%) of 102 RCTs since 2020, respectively; the annual increases were 1.9% (95% CI, 1.4%-2.3%), 3.3% (95% CI, 2.9%-3.7%), and 3.0% (95% CI, 2.5%-3.5%), respectively. The proportion of RCTs citating prior systematic reviews varied considerably across clinical specialties, ranging from 28 of 106 RCTs (26.4%) in ophthalmology to 386 of 553 RCTs (69.8%) in psychiatry (P < .001). RCTs with 100 participants or more (risk ratio [RR], 1.16; 95% CI, 1.03-1.30), nonindustry funding (RR, 1.43; 95% CI, 1.27-1.61), and authors from high-income countries (RR, 1.10; 95% CI, 1.03-1.17) were more likely to cite systematic reviews than those with fewer than 100 participants, industry funding, and authors from low- and middle-income countries, respectively. A journal requirement to cite systematic reviews was not associated with the likelihood of citing a systematic review. Conclusions and Relevance: This study found that the citation of prior systematic reviews in RCT reports improved over time, but approximately 40% of RCTs failed to do so. These findings suggest that reference to prior evidence for initiating, designing, and reporting RCTs should be further emphasized to assure clinical relevance, improve methodological quality, and facilitate interpretation of new results.


Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto , Revisões Sistemáticas como Assunto , Humanos
6.
Syst Rev ; 11(1): 277, 2022 12 23.
Artigo em Inglês | MEDLINE | ID: mdl-36564846

RESUMO

BACKGROUND: A systematically and transparently prepared research priority-setting process within a specific scientific area is essential in order to develop a comprehensive and progressive evidence-based approach that will have a substantial societal impact on the site of interest. On the basis of two consensus workshops, the authors suggest the following methods for all such processes: use of experts, stakeholder involvement, literature review, and ranking. OBJECTIVES: The identification, categorisation, and discussion of methods for preparing a research prioritisation process. METHODS: Eligibility criteria: Evidence synthesis includes original studies presenting a research prioritisation process and which listed the methods used to create a research prioritisation process. Only evidence syntheses related to health research were included. DATA SOURCES: We searched the following electronic databases, without limiting by date or language: MEDLINE Ovid, Embase Ovid, Epistemonikos, and CINAHL EBSCO. CHARTING METHODS: The methods used were mapped and broken down into different elements, and the use of the elements was determined. To support the mapping, (A) all of the elements were collapsed into unique categories, and (B) four essential categories were selected as crucial to a successful research prioritisation process. RESULTS: Twelve evidence syntheses were identified, including 416 original studies. The identification and categorisation of methods used resulted in 13 unique categories of methods used to prepare a research agenda. CONCLUSION: None of the identified categories was used in all of the original studies. Surprisingly, all four of the essential categories were used in only one of the 416 original studies identified. There is seemingly no international consensus on which methods to use when preparing a research prioritisation process. PROTOCOL REGISTRATION: The protocol was registered in Open Science Framework ( https://osf.io/dygz8/ ).


Assuntos
Consenso , Humanos
7.
Syst Rev ; 11(1): 241, 2022 11 15.
Artigo em Inglês | MEDLINE | ID: mdl-36380367

RESUMO

BACKGROUND: Several studies have documented the production of wasteful research, defined as research of no scientific importance and/or not meeting societal needs. We argue that this redundancy in research may to a large degree be due to the lack of a systematic evaluation of the best available evidence and/or of studies assessing societal needs. OBJECTIVES: The aim of this scoping review is to (A) identify meta-research studies evaluating if redundancy is present within biomedical research, and if so, assessing the prevalence of such redundancy, and (B) to identify meta-research studies evaluating if researchers had been trying to minimise or avoid redundancy. ELIGIBILITY CRITERIA: Meta-research studies (empirical studies) were eligible if they evaluated whether redundancy was present and to what degree; whether health researchers referred to all earlier similar studies when justifying and designing a new study and/or when placing new results in the context of earlier similar trials; and whether health researchers systematically and transparently considered end users' perspectives when justifying and designing a new study. SOURCES OF EVIDENCE: The initial overall search was conducted in MEDLINE, Embase via Ovid, CINAHL, Web of Science, Social Sciences Citation Index, Arts & Humanities Citation Index, and the Cochrane Methodology Register from inception to June 2015. A 2nd search included MEDLINE and Embase via Ovid and covered January 2015 to 26 May 2021. No publication date or language restrictions were applied. CHARTING METHODS: Charting methods included description of the included studies, bibliometric mapping, and presentation of possible research gaps in the identified meta-research. RESULTS: We identified 69 meta-research studies. Thirty-four (49%) of these evaluated the prevalence of redundancy and 42 (61%) studies evaluated the prevalence of a systematic and transparent use of earlier similar studies when justifying and designing new studies, and/or when placing new results in context, with seven (10%) studies addressing both aspects. Only one (1%) study assessed if the perspectives of end users had been used to inform the justification and design of a new study. Among the included meta-research studies evaluating whether redundancy was present, only two of nine health domains (medical areas) and only two of 10 research topics (different methodological types) were represented. Similarly, among the included meta-research studies evaluating whether researchers had been trying to minimise or avoid redundancy, only one of nine health domains and only one of 10 research topics were represented. CONCLUSIONS THAT RELATE TO THE REVIEW QUESTIONS AND OBJECTIVES: Even with 69 included meta-research studies, there was a lack of information for most health domains and research topics. However, as most included studies were evaluating across different domains, there is a clear indication of a high prevalence of redundancy and a low prevalence of trying to minimise or avoid redundancy. In addition, only one meta-research study evaluated whether the perspectives of end users were used to inform the justification and design of a new study. SYSTEMATIC REVIEW REGISTRATION: Protocol registered at Open Science Framework: https://osf.io/3rdua/ (15 June 2021).


Assuntos
Revisões Sistemáticas como Assunto , Humanos , MEDLINE
8.
PLoS One ; 17(10): e0276955, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36315526

RESUMO

BACKGROUND: Redundancy is an unethical, unscientific, and costly challenge in clinical health research. There is a high risk of redundancy when existing evidence is not used to justify the research question when a new study is initiated. Therefore, the aim of this study was to synthesize meta-research studies evaluating if and how authors of clinical health research studies use systematic reviews when initiating a new study. METHODS: Seven electronic bibliographic databases were searched (final search June 2021). Meta-research studies assessing the use of systematic reviews when justifying new clinical health studies were included. Screening and data extraction were performed by two reviewers independently. The primary outcome was defined as the percentage of original studies within the included meta-research studies using systematic reviews of previous studies to justify a new study. Results were synthesized narratively and quantitatively using a random-effects meta-analysis. The protocol has been registered in Open Science Framework (https://osf.io/nw7ch/). RESULTS: Twenty-one meta-research studies were included, representing 3,621 original studies or protocols. Nineteen of the 21 studies were included in the meta-analysis. The included studies represented different disciplines and exhibited wide variability both in how the use of previous systematic reviews was assessed, and in how this was reported. The use of systematic reviews to justify new studies varied from 16% to 87%. The mean percentage of original studies using systematic reviews to justify their study was 42% (95% CI: 36% to 48%). CONCLUSION: Justification of new studies in clinical health research using systematic reviews is highly variable, and fewer than half of new clinical studies in health science were justified using a systematic review. Research redundancy is a challenge for clinical health researchers, as well as for funders, ethics committees, and journals.


Assuntos
Relatório de Pesquisa , Bases de Dados Bibliográficas
9.
Syst Rev ; 11(1): 191, 2022 09 05.
Artigo em Inglês | MEDLINE | ID: mdl-36064610

RESUMO

BACKGROUND: With the exponential growth of published systematic reviews (SR), there is a high potential for overlapping and redundant duplication of work. Prospective protocol registration gives the opportunity to assess the added value of a new study or review, thereby potentially reducing research waste and simultaneously increasing transparency and research quality. The PROSPERO database for SR protocol registration was launched 10 years ago. This study aims to assess the proportion SRs of intervention studies with a protocol registration (or publication) and explore associations of SR characteristics with protocol registration status. METHODS: PubMed was searched for SRs of human intervention studies published in January 2020 and January 2021. After random-stratified sampling and eligibility screening, data extraction on publication and journal characteristics, and protocol registration status, was performed. Both descriptive and multivariable comparative statistical analyses were performed. RESULTS: A total of 357 SRs (2020: n = 163; 2021: n = 194) were included from a random sample of 1267 publications. Of the published SRs, 38% had a protocol. SRs that reported using PRISMA as a reporting guideline had higher odds of having a protocol than publications that did not report PRISMA (OR 2.71; 95% CI: 1.21 to 6.09). SRs with a higher journal impact factor had higher odds of having a protocol (OR 1.12; 95% CI 1.04 to 1.25). Publications from Asia had a lower odds of having a protocol (OR 0.43; 95% CI 0.23 to 0.80, reference category = Europe). Of the 33 SRs published in journals that endorse PROSPERO, 45% did not have a protocol. Most SR protocols were registered in PROSPERO (n = 129; 96%). CONCLUSIONS: We found that 38% of recently published SRs of interventions reported a registered or published protocol. Protocol registration was significantly associated with a higher impact factor of the journal publishing the SR and a more frequent self-reported use of the PRISMA guidelines. In some parts of the world, SR protocols are more often registered or published than others. To guide strategies to increase the uptake of SR protocol registration, further research is needed to gain understanding of the benefits and informativeness of SRs protocols among different stakeholders. SYSTEMATIC REVIEW REGISTRATION: osf.io/9kj7r/.


Assuntos
Relatório de Pesquisa , Revisões Sistemáticas como Assunto , Ásia , Humanos , Fator de Impacto de Revistas , Estudos Prospectivos , Projetos de Pesquisa
10.
Syst Rev ; 11(1): 189, 2022 Sep 05.
Artigo em Inglês | MEDLINE | ID: mdl-36064741

RESUMO

BACKGROUND: Results of new studies should be interpreted in the context of what is already known to compare results and build the state of the science. This systematic review and meta-analysis aimed to identify and synthesise results from meta-research studies examining if original studies within health use systematic reviews to place their results in the context of earlier, similar studies. METHODS: We searched MEDLINE (OVID), EMBASE (OVID), and the Cochrane Methodology Register for meta-research studies reporting the use of systematic reviews to place results of original clinical studies in the context of existing studies. The primary outcome was the percentage of original studies included in the meta-research studies using systematic reviews or meta-analyses placing new results in the context of existing studies. Two reviewers independently performed screening and data extraction. Data were synthesised using narrative synthesis and a random-effects meta-analysis was performed to estimate the mean proportion of original studies placing their results in the context of earlier studies. The protocol was registered in Open Science Framework. RESULTS: We included 15 meta-research studies, representing 1724 original studies. The mean percentage of original studies within these meta-research studies placing their results in the context of existing studies was 30.7% (95% CI [23.8%, 37.6%], I2=87.4%). Only one of the meta-research studies integrated results in a meta-analysis, while four integrated their results within a systematic review; the remaining cited or referred to a systematic review. The results of this systematic review are characterised by a high degree of heterogeneity and should be interpreted cautiously. CONCLUSION: Our systematic review demonstrates a low rate of and great variability in using systematic reviews to place new results in the context of existing studies. On average, one third of the original studies contextualised their results. Improvement is still needed in researchers' use of prior research systematically and transparently-also known as the use of an evidence-based research approach, to contribute to the accumulation of new evidence on which future studies should be based. SYSTEMATIC REVIEW REGISTRATION: Open Science registration number https://osf.io/8gkzu/.

11.
J Clin Epidemiol ; 150: 126-141, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-35793778

RESUMO

OBJECTIVES: This systematic review aimed to identify the characteristics and application of citation analyses in evaluating the justification, design, and placement of the research results of clinical health studies in the context of earlier similar studies. STUDY DESIGN AND SETTING: We searched MEDLINE (Ovid), Embase (Ovid), and the Cochrane Methodology Register for meta-research studies. We included meta-research studies assessing whether researchers used earlier similar studies and/or systematic reviews of such studies to inform the justification or design of a new study, whether researchers used systematic reviews to inform the interpretation of new results, and meta-research studies assessing whether redundant studies were published within a specific area. The results are presented as a narrative synthesis. RESULTS: A total of 27 studies were included. How authors of citation analyses define their outcomes appears rather arbitrary, as does how the reference of a landmark review or adherence to reporting guidelines was expected to contribute to the initiation, justification, design, or contextualization of relevant clinical trials. CONCLUSION: Continued and improved efforts to promote evidence-based research are needed, including clearly defined and justified outcomes in meta-research studies to monitor the implementation of an evidence-based approach.


Assuntos
Pesquisa , Humanos
12.
J Rehabil Med ; 54: jrm00250, 2022 Jan 11.
Artigo em Inglês | MEDLINE | ID: mdl-35642324

RESUMO

OBJECTIVE:  To evaluate the effects and safety of exercise training, and to determine the most effective exercise intervention for people with Duchenne muscular dystrophy. Exercise training was compared with no training, placebo or alternative exercise training. Primary outcomes were functioning and health-related quality of life. Secondary outcomes were muscular strength, endurance and lung function.  Data sources: A systematic literature search was conducted in Medline, EMBASE, CINAHL, Cochrane Central, PEDro and Scopus.  Study selection and data extraction: Screening, data extraction, risk of bias and quality assessment were carried out. Risk of bias was assessed using the Cochrane Collaborations risk of bias tools. The certainty of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation. DATA SYNTHESIS: Twelve studies with 282 participants were included. A narrative synthesis showed limited or no improvements in functioning compared with controls. Health-related quality of life was assessed in only 1 study. A meta-analysis showed a significant difference in muscular strength and endurance in favour of exercise training compared with no training and placebo. However, the certainty of evidence was very low. CONCLUSION: Exercise training may be beneficial in Duchenne muscular dystrophy, but the evidence remains uncertain. Further research is needed on exercise training to promote functioning and health-related quality of life in Duchenne muscular dystrophy.


Assuntos
Distrofia Muscular de Duchenne , Exercício Físico , Humanos , Força Muscular , Distrofia Muscular de Duchenne/complicações , Distrofia Muscular de Duchenne/terapia , Qualidade de Vida
13.
J Clin Epidemiol ; 145: 1-13, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35045317

RESUMO

OBJECTIVE: Our aim was to identify and synthesize the results from meta-research studies to determine whether and how authors of original studies in clinical health research use systematic reviews when designing new studies. STUDY DESIGN AND SETTING: For this systematic review, we searched MEDLINE (OVID), Embase (OVID) and the Cochrane Methodology Register. We included meta-research studies and primary outcome was the percentage of original studies using systematic reviews to design their study. Risk of bias was assessed using an ad hoc created list of ten items. The results are presented both as a narrative synthesis and a meta-analysis. RESULTS: Sixteen studies were included. The use of a systematic review to inform the design of new clinical studies varied between 0% and 73%, with a mean percentage of 17%. The number of components of the design in which information from previous systematic reviews was used varied from three to 11. CONCLUSION: Clinical health research is characterized by variability regarding the extent to which systematic reviews are used to guide the design. An evidence-based research (EBR) approach towards research design when new clinical health studies are designed is necessary to decrease potential research redundancy and increase end-user value.


Assuntos
Projetos de Pesquisa , Humanos , MEDLINE
14.
Arthritis Care Res (Hoboken) ; 74(10): 1723-1735, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-33973383

RESUMO

OBJECTIVE: To gauge the evidence of periodontal therapy's impact on measures of disease activity and systemic inflammatory burden in individuals with rheumatoid arthritis (RA). METHODS: A search for randomized trials and controlled cohort studies of RA patients with periodontitis was conducted on April 7, 2019, with an update on December 17, 2020 in PubMed, Cochrane Library (CENTRAL), Embase, ClinicalTrials.gov, and the World Health Organization International Clinical Trial Registry Platform portal. Two reviewers screened titles and abstracts and selected papers for full-text review. We used Outcome Measures in Rheumatology (OMERACT)-endorsed outcome domains for RA trials and summarized continuous outcomes using standardized mean differences (SMDs) with 95% confidence intervals (95% CIs). We evaluated inconsistency using the I2 statistic and combined SMDs using random-effects models for the meta-analyses; fixed-effect meta-analyses were used for sensitivity analysis. To explore heterogeneity, we added stratified/meta-regression analyses, expressed in T2 . RESULTS: Of the 1,909 studies identified, 9 (including 10 comparisons) were eligible for quantitative synthesis (n = 388). Evidence suggested a favorable effect of periodontal treatment on disease activity (SMD -0.88 [95% CI -1.38, -0.38]; n = 311). The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to judge the estimates' certainty; evidence rated as having low or very low certainty indicated that any possible effect of periodontal treatment in RA is likely to change as more evidence is provided. Selection bias and RA medication stability were highlighted as sources of heterogeneity between studies. CONCLUSION: There is an urgent need for a well-designed prospective cohort study (preferably a randomized controlled trial) of patients with RA and periodontitis using rigorous protocols, standardized diagnostic criteria, data collection, and adequate duration of follow-up.


Assuntos
Artrite Reumatoide , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/terapia , Humanos , Estudos Prospectivos
15.
J Clin Epidemiol ; 143: 73-80, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-34780978

RESUMO

OBJECTIVE: We sought to map the landscape of trials investigating hydroxychloroquine (HCQ) for SARS-CoV-2 in order to draw conclusions about how clinical trials have been conducted in the pandemic environment and offer potential regulatory recommendations. STUDY DESIGN AND SETTING: We identified and captured data related to registered studies using HCQ to treat SARS-CoV-2 registered with the publicly available National Institutes of Health (NIH) Clinical Trials Registry between February and November 2020. RESULTS: Between February and November 2020, 206 studies investigating HCQ in SARS-CoV-2 were registered with the NIH Clinical Trials Registry. As of November 2020, 135 studies were listed as ongoing, 22 have been completed, and 46 are either suspended or have been terminated. Reasons for suspension or termination included difficulties with patient recruitment (n = 9), emerging evidence showing a lack of benefit of HCQ (n = 7), and recommendations by regulatory boards to discontinue (n = 10). CONCLUSION: Many clinical trials of HCQ were launched in the first months of the pandemic, and a significant proportion of them remained active as of November 2020. The medical community appears to have responded very quickly to political interest in HCQ, while responding much more slowly to the evolving medical evidence of its lack of efficacy.


Assuntos
Tratamento Farmacológico da COVID-19 , COVID-19 , Ensaios Clínicos como Assunto , Hidroxicloroquina , Antivirais/uso terapêutico , COVID-19/epidemiologia , Ensaios Clínicos como Assunto/ética , Humanos , Hidroxicloroquina/uso terapêutico , National Institutes of Health (U.S.) , Sistema de Registros , SARS-CoV-2 , Estados Unidos/epidemiologia
17.
Pol Arch Intern Med ; 131(9): 848-853, 2021 09 30.
Artigo em Inglês | MEDLINE | ID: mdl-34590450

RESUMO

Meta-research has highlighted that up to half of all clinical studies may be redundant and do not add any value. We suggest that such unnecessary studies will continue to be prepared and published unless researchers systematically and transparently identify and consider the existing evidence. This approach of identifying and utilizing the existing knowledge base before and after conducting a new trial is called Evidence-Based Research (EBR), defined as the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid, efficient, and accessible manner. This paper describes the issues that have led to the development of the EBR approach, suggests what researchers should do to avoid wasteful and unnecessary research, and outlines the benefits of conducting evidence-based research. Finally, we present the international EBR Network established to support the efforts to minimize waste in research and increase the value of clinical studies.


Assuntos
Medicina Interna , Projetos de Pesquisa , Humanos
18.
Death Stud ; 45(7): 508-521, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-31390307

RESUMO

Despite high rates of drug-related deaths (DRDs), drug-related bereavement has been sparsely investigated. A systematic literature search for qualitative and quantitative studies was conducted. Studies on bereaved DRD family members and systems influencing bereavement were eligible for inclusion. Eight studies were included. Three themes emerged from the thematic analysis (Emotional Roller Coaster, Lack of Understanding by the Social World, and Meaning Making) describing an emotional and existential overload, stigmatization and lack of understanding and help from support systems. The results also shed light on life after the loss. Directions for further research were subsequently outlined.


Assuntos
Luto , Preparações Farmacêuticas , Família , Pesar , Humanos , Apoio Social
19.
J Clin Epidemiol ; 129: 158-166, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32987159

RESUMO

BACKGROUND AND OBJECTIVES: There is considerable actual and potential waste in research. The aim of this article is to describe how using an evidence-based research approach before conducting a study helps to ensure that the new study truly adds value. STUDY DESIGN AND SETTING: Evidence-based research is the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid, efficient, and accessible manner. In this second article of the evidence-based research series, we describe how to apply an evidence-based research approach before starting a new study. RESULTS: Before a new study is performed, researchers need to provide a solid justification for it using the available scientific knowledge as well as the perspectives of end users. The key method for both is to conduct a systematic review of earlier relevant studies. CONCLUSION: Describing the ideal process illuminates the challenges and opportunities offered through the suggested evidence-based research approach. A systematic and transparent approach is needed to provide justification for and to optimally design a relevant and necessary new study.


Assuntos
Pesquisa Biomédica , Ensaios Clínicos como Assunto , Medicina Baseada em Evidências/métodos , Projetos de Pesquisa , Revisões Sistemáticas como Assunto/métodos , Pesquisa Biomédica/métodos , Pesquisa Biomédica/organização & administração , Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/organização & administração , Humanos , Avaliação das Necessidades , Reprodutibilidade dos Testes , Projetos de Pesquisa/normas , Projetos de Pesquisa/tendências , Resultado do Tratamento
20.
J Clin Epidemiol ; 129: 167-171, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32979490

RESUMO

BACKGROUND AND OBJECTIVE: There is considerable actual and potential waste in research. Using evidence-based research (EBR) can ensure the value of a new study. The aim of this article, the third in a series, is to describe an EBR approach to putting research results into context. STUDY DESIGN AND SETTING: EBR is the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid, efficient, and accessible manner. In this third and final article of a series, we describe how to use the context of existing evidence to reach and present a trustworthy and useful conclusion when reporting results from a new clinical study. RESULTS: We describe a method, the EBR approach, that by using a systematic and transparent consideration of earlier similar studies when interpreting and presenting results from a new original study will ensure usefulness of the conclusion. CONCLUSION: Using an EBR approach will improve the usefulness of a clinical study by providing the context to draw more valid conclusions and explicit information about new research needs.


Assuntos
Pesquisa Biomédica , Ensaios Clínicos como Assunto , Medicina Baseada em Evidências/métodos , Projetos de Pesquisa , Revisões Sistemáticas como Assunto/métodos , Pesquisa Biomédica/métodos , Pesquisa Biomédica/organização & administração , Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/organização & administração , Estudos de Avaliação como Assunto , Humanos , Reprodutibilidade dos Testes , Projetos de Pesquisa/normas , Projetos de Pesquisa/tendências , Resultado do Tratamento
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