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1.
BMC Health Serv Res ; 24(1): 1195, 2024 Oct 08.
Artigo em Inglês | MEDLINE | ID: mdl-39375664

RESUMO

BACKGROUND: Inadequate medication knowledge may contribute to inappropriate medication use and treatment harms. We aimed to map and synthesise the existing evidence on patients' knowledge of the indications for their medications. METHOD: We searched MEDLINE, Embase, CINAHL, PsychInfo and the Cochrane Library for studies that assessed patients' knowledge of the indications for their medications from inception to June 16, 2022. A pair of reviewers independently screened and extracted data on study characteristics, aims, and methods used to assess and report patients' knowledge of the indications for their medications. RESULTS: We included 99 studies conducted in 33 countries, published between 1979 and 2021, with 42,377 participants in total (median 126 participants [Interquartile range: 63-338]). Studies were observational (n = 77), experimental (n = 18), or qualitative interviews (n = 4). The exact question used to assess knowledge of the indications was reported in 27 studies and was phrased in 25 different ways. Knowledge of the indications was reported as a proportion of either 1) all participants (n = 65) or 2) the total number of medications used by all patients (n = 13). Sixteen studies used both reporting methods, while five only reported a proportion without specifying the denominator. Fourteen studies in various populations reported the number of participants with correct knowledge of all their medications, ranging from 19% (long-term psychiatric in-patients) to 87% (general practice patients). CONCLUSION: We did not identify any established scientific standard for assessing patients' knowledge of the indications for their medications. The wide range of study methodologies and reporting styles observed call for a methodological consensus in this research field. Estimates of correct knowledge varied widely between studies, but whether this was due to differences in study populations or study methodology could not be determined. Furthermore, we did not identify any study investigating whether participants' knowledge of the indications for their medications was associated with the quality, e.g. appropriateness, of their treatment.


Assuntos
Conhecimentos, Atitudes e Prática em Saúde , Humanos , Feminino
2.
J Clin Epidemiol ; 175: 111512, 2024 Aug 31.
Artigo em Inglês | MEDLINE | ID: mdl-39222724

RESUMO

BACKGROUND AND OBJECTIVE: Randomized controlled trials (RCTs) inform health-care decisions. Unfortunately, some published RCTs contain false data, and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesize all RCTs which have been conducted on a given topic. This means that any of these 'problematic studies' are likely to be included, but there are no agreed methods for identifying them. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project is developing a tool to identify problematic RCTs in systematic reviews of health care-related interventions. The tool will guide the user through a series of 'checks' to determine a study's authenticity. The first objective in the development process is to assemble a comprehensive list of checks to consider for inclusion. METHODS: We assembled an initial list of checks for assessing the authenticity of research studies, with no restriction to RCTs, and categorized these into five domains: Inspecting results in the paper; Inspecting the research team; Inspecting conduct, governance, and transparency; Inspecting text and publication details; Inspecting the individual participant data. We implemented this list as an online survey, and invited people with expertise and experience of assessing potentially problematic studies to participate through professional networks and online forums. Participants were invited to provide feedback on the checks on the list, and were asked to describe any additional checks they knew of, which were not featured in the list. RESULTS: Extensive feedback on an initial list of 102 checks was provided by 71 participants based in 16 countries across five continents. Fourteen new checks were proposed across the five domains, and suggestions were made to reword checks on the initial list. An updated list of checks was constructed, comprising 116 checks. Many participants expressed a lack of familiarity with statistical checks, and emphasized the importance of feasibility of the tool. CONCLUSION: A comprehensive list of trustworthiness checks has been produced. The checks will be evaluated to determine which should be included in the INSPECT-SR tool. PLAIN LANGUAGE SUMMARY: Systematic reviews draw upon evidence from randomized controlled trials (RCTs) to find out whether treatments are safe and effective. The conclusions from systematic reviews are often very influential, and inform both health-care policy and individual treatment decisions. However, it is now clear that the results of many published RCTs are not genuine. In some cases, the entire study may have been fabricated. It is not usual for the veracity of RCTs to be questioned during the process of compiling a systematic review. As a consequence, these "problematic studies" go unnoticed, and are allowed to contribute to the conclusions of influential systematic reviews, thereby influencing patient care. This prompts the question of how these problematic studies could be identified. In this study, we created an extensive list of checks that could be performed to try to identify these studies. We started by assembling a list of checks identified in previous research, and conducting a survey of experts to ask whether they were aware of any additional methods, and to give feedback on the list. As a result, a list of 116 potential "trustworthiness checks" was created. In subsequent research, we will evaluate these checks to see which should be included in a tool, INveStigating ProblEmatic Clinical Trials in Systematic Reviews, which can be used to detect problematic studies.

3.
Ugeskr Laeger ; 186(24)2024 Jun 10.
Artigo em Dinamarquês | MEDLINE | ID: mdl-38903039
4.
medRxiv ; 2024 Mar 25.
Artigo em Inglês | MEDLINE | ID: mdl-38585914

RESUMO

Background: Randomised controlled trials (RCTs) inform healthcare decisions. Unfortunately, some published RCTs contain false data, and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs which have been conducted on a given topic. This means that any of these 'problematic studies' are likely to be included, but there are no agreed methods for identifying them. The INSPECT-SR project is developing a tool to identify problematic RCTs in systematic reviews of healthcare-related interventions. The tool will guide the user through a series of 'checks' to determine a study's authenticity. The first objective in the development process is to assemble a comprehensive list of checks to consider for inclusion. Methods: We assembled an initial list of checks for assessing the authenticity of research studies, with no restriction to RCTs, and categorised these into five domains: Inspecting results in the paper; Inspecting the research team; Inspecting conduct, governance, and transparency; Inspecting text and publication details; Inspecting the individual participant data. We implemented this list as an online survey, and invited people with expertise and experience of assessing potentially problematic studies to participate through professional networks and online forums. Participants were invited to provide feedback on the checks on the list, and were asked to describe any additional checks they knew of, which were not featured in the list. Results: Extensive feedback on an initial list of 102 checks was provided by 71 participants based in 16 countries across five continents. Fourteen new checks were proposed across the five domains, and suggestions were made to reword checks on the initial list. An updated list of checks was constructed, comprising 116 checks. Many participants expressed a lack of familiarity with statistical checks, and emphasized the importance of feasibility of the tool. Conclusions: A comprehensive list of trustworthiness checks has been produced. The checks will be evaluated to determine which should be included in the INSPECT-SR tool.

5.
BMJ Open ; 14(3): e084164, 2024 Mar 11.
Artigo em Inglês | MEDLINE | ID: mdl-38471680

RESUMO

INTRODUCTION: Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare-related interventions. METHODS AND ANALYSIS: The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: (1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, (2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, (3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in, (4) a consensus meeting to select checks to be included in a draft tool and to determine its format and (5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies and will help patients by protecting them from the influence of false data on their healthcare. ETHICS AND DISSEMINATION: The University of Manchester ethics decision tool was used, and this returned the result that ethical approval was not required for this project (30 September 2022), which incorporates secondary research and surveys of professionals about subjects relating to their expertise. Informed consent will be obtained from all survey participants. All results will be published as open-access articles. The final tool will be made freely available.


Assuntos
Medicina Baseada em Evidências , Projetos de Pesquisa , Humanos , Consenso , Medicina Baseada em Evidências/métodos , Consentimento Livre e Esclarecido , Ensaios Clínicos Controlados Aleatórios como Assunto , Revisões Sistemáticas como Assunto
6.
Ugeskr Laeger ; 186(13)2024 03 25.
Artigo em Dinamarquês | MEDLINE | ID: mdl-38533856

RESUMO

A systematic review provides an overview of primary studies investigating a given research question, e.g., the effect of a certain treatment. Individual study results are sometimes synthesised in a meta-analysis. A critical reader should consider whether the systematic review is relevant and reliable, e.g., does it follow a protocol, address the risk of bias, and consider potential heterogeneity. PRISMA 2020 guideline recommends a minimum set of items that should be reported in a systematic review article, and AMSTAR 2 and ROBIS are tools for critical appraisal of systematic reviews.


Assuntos
Revisões Sistemáticas como Assunto , Viés , Revisões Sistemáticas como Assunto/normas
7.
Ugeskr Laeger ; 185(45)2023 11 06.
Artigo em Dinamarquês | MEDLINE | ID: mdl-37987450

RESUMO

The randomised clinical trial is the most reliable study design to compare the effects of different interventions, however, the methodological quality of randomised clinical trials varies. In this review, the central considerations for critically appraising a randomised clinical trial are described along with an example, terminological references, description of design variants and reporting guidelines and appraisal tools. This review aims at helping clinicians and other users of randomised clinical trials to assess the trustworthiness and relevance of trial results for their own practice.


Assuntos
Projetos de Pesquisa , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
10.
medRxiv ; 2023 Nov 13.
Artigo em Inglês | MEDLINE | ID: mdl-37873409

RESUMO

Introduction: Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INSPECT-SR project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare related interventions. Methods and analysis: The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: 1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, 2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, 3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in 4) a consensus meeting to select checks to be included in a draft tool and to determine its format, 5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies, and will help patients by protecting them from the influence of false data on their healthcare.

11.
J Clin Epidemiol ; 161: 104-115, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37399968

RESUMO

OBJECTIVES: To compare the contemporary Cochrane review approach for retrieving information on trial funding and researchers' conflicts of interest with a structured approach for information retrieval. STUDY DESIGN AND SETTING: Methodological study of 100 Cochrane reviews from August to December 2020 and one randomly selected trial from each review. Reporting of trial funding and researchers' conflicts of interest in reviews was compared with information identified using a structured retrieval process, and time to retrieve information was noted. We also formulated a guide to systematic reviewers for efficient information retrieval. RESULTS: Sixty-eight of 100 Cochrane reviews reported trial funding and 24 reported trial researchers' conflicts of interest. A simple structured approach, searching only trial publications (including conflicts of interest disclosure forms), identified funding for 16 additional trials and conflicts of interest information for 39 additional trials. A comprehensive structured approach, searching multiple information sources, identified funding for two additional trials and conflicts of interest for 14 additional trials. The median time to retrieve information was 10 minutes per trial (interquartile range: 7-15) for the simple approach and 20 minutes (11-43) for the comprehensive approach. CONCLUSION: A structured information retrieval approach improves identification of funding and researchers' conflicts of interest in trials included in Cochrane reviews.


Assuntos
Conflito de Interesses , Revelação , Humanos , Armazenamento e Recuperação da Informação , Revisões Sistemáticas como Assunto , Ensaios Clínicos como Assunto
13.
Cochrane Database Syst Rev ; 1: CD008986, 2023 01 23.
Artigo em Inglês | MEDLINE | ID: mdl-36688482

RESUMO

BACKGROUND: A medication review can be defined as a structured evaluation of a patient's medication conducted by healthcare professionals with the aim of optimising medication use and improving health outcomes. Optimising medication therapy though medication reviews may benefit hospitalised patients. OBJECTIVES: We examined the effects of medication review interventions in hospitalised adult patients compared to standard care or to other types of medication reviews on all-cause mortality, hospital readmissions, emergency department contacts and health-related quality of life. SEARCH METHODS: In this Cochrane Review update, we searched for new published and unpublished trials using the following electronic databases from 1 January 2014 to 17 January 2022 without language restrictions: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP). To identify additional trials, we searched the reference lists of included trials and other publications by lead trial authors, and contacted experts. SELECTION CRITERIA: We included randomised trials of medication reviews delivered by healthcare professionals for hospitalised adult patients. We excluded trials including outpatients and paediatric patients. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, extracted data and assessed risk of bias. We contacted trial authors for data clarification and relevant unpublished data. We calculated risk ratios (RRs) for dichotomous data and mean differences (MDs) or standardised mean differences (SMDs) for continuous data (with 95% confidence intervals (CIs)). We used the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach to assess the overall certainty of the evidence. MAIN RESULTS: In this updated review, we included a total of 25 trials (15,076 participants), of which 15 were new trials (11,501 participants). Follow-up ranged from 1 to 20 months. We found that medication reviews in hospitalised adults may have little to no effect on mortality (RR 0.96, 95% CI 0.87 to 1.05; 18 trials, 10,108 participants; low-certainty evidence); likely reduce hospital readmissions (RR 0.93, 95% CI 0.89 to 0.98; 17 trials, 9561 participants; moderate-certainty evidence); may reduce emergency department contacts (RR 0.84, 95% CI 0.68 to 1.03; 8 trials, 3527 participants; low-certainty evidence) and have very uncertain effects on health-related quality of life (SMD 0.10, 95% CI -0.10 to 0.30; 4 trials, 392 participants; very low-certainty evidence). AUTHORS' CONCLUSIONS: Medication reviews in hospitalised adult patients likely reduce hospital readmissions and may reduce emergency department contacts. The evidence suggests that mediation reviews may have little to no effect on mortality, while the effect on health-related quality of life is very uncertain. Almost all trials included elderly polypharmacy patients, which limits the generalisability of the results beyond this population.


Assuntos
Revisão de Medicamentos , Qualidade de Vida , Adulto , Idoso , Criança , Humanos , Morbidade , Pacientes Ambulatoriais , Readmissão do Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto
14.
Res Synth Methods ; 14(2): 144-155, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-36357935

RESUMO

We investigated to which degree commercial funding is associated with estimated intervention effects in randomized trials. We included meta-epidemiological studies with published data on the association between commercial funding and results or conclusions of randomized trials. We searched five databases and other sources. We selected one result per meta-epidemiological study, preferably unadjusted ratio of odds ratios (ROR), for example, odds ratio(commercial funding)/odds ratio(noncommercial funding). We pooled RORs in random-effects meta-analyses (ROR <1 indicated exaggerated intervention effects in commercially funded trials), subgrouped (preplanned) by study aim: commercial funding per se versus risk of commercial funder influence. We included eight meta-epidemiological studies (264 meta-analyses, 2725 trials). The summary ROR was 0.95 (95% confidence interval 0.85-1.06). Subgroup analysis revealed a difference (p = 0.02) between studies of commercial funding per se, ROR 1.06 (0.95-1.17) and studies of risk of commercial funder influence, ROR 0.88 (0.79-0.97). In conclusion, we found no statistically significant association between commercial funding and estimated intervention effects when combining studies of commercial funding per se and studies of risk of commercial funder influence. A preplanned subgroup analysis indicated that trials with high risk of commercial funder influence exaggerated intervention effects by 12% (21%-3%), on average. Our results differ from previous theoretical considerations and findings from methodological studies and therefore call for confirmation. We suggest it is prudent to interpret results from commercially funded trials with caution, especially when there is a risk that the funder had direct influence on trial design, conduct, analysis, or reporting.


Assuntos
Estudos Epidemiológicos , Razão de Chances , Metanálise como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto
15.
BMC Med Educ ; 22(1): 812, 2022 Nov 26.
Artigo em Inglês | MEDLINE | ID: mdl-36435782

RESUMO

BACKGROUND: Concerns around staffs' and students' interactions with commercial entities, for example drug companies, have led several North American medical schools to implement conflict of interest (COI) policies. However, little is known about COI policies at European medical schools. We analysed the content and strength of COI policies at Scandinavian medical schools. METHODS: We searched the websites of medical schools in Denmark, Norway, and Sweden and emailed the Deans for additional information. Using comparable methodology to previous studies, the strength of the COI policies was rated on a scale from 0 to 2 across 11 items (higher score more restrictive); we also assessed the presence of oversight mechanisms and sanctions. RESULTS: We identified 77 unique policies for 15 medical schools (range 2-8 per school). Most of the policies (n = 72; 94%) were University wide and only five (6%) were specific for the medical schools. For six of eleven items one or more schools had a restrictive policy (score of two). None of the schools had a restrictive policy for the five additional items (speaking relationships, sales representatives, on-site education activities, medical school curriculum, and drug samples). Honoraria was the item with the highest score, with eight of the 15 schools having a score of two. Thirteen of the 15 schools had policies that identified a party responsible for policy oversight and mentioned sanctions for non-compliance. CONCLUSION: Our study provides the first evaluation of all Scandinavian medical schools' COI policies. We found that the content of COI policies varies widely and still has shortcomings. We encourage Scandinavian medical schools to develop more stringent COI policies to regulate industry interactions with both faculty and students.


Assuntos
Conflito de Interesses , Faculdades de Medicina , Humanos , Estudos Transversais , Políticas , Política Organizacional
16.
J Clin Virol ; 150-151: 105159, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35487093

RESUMO

BACKGROUND: Chronic hepatitis B virus (HBV) treatment consists of nucleos(t)ide analogues to suppress viral replication. The HBV inhibitor tenofovir has a high barrier to resistance, however, evidence of virus-escape is emerging. This study investigates HBV evolution in patients undergoing tenofovir treatment with the primary aim to assess the emergence of putative resistance mutations. METHODS: HBV DNA was extracted from blood samples of two patients with HBeAg-positive chronic HBV infection and persistent viremia despite tenofovir treatment, and subsequently amplified by PCR before full-length HBV genomes were assembled by deep sequencing. The mutation linkage within the viral population was evaluated by clonal analysis of amplicons. RESULTS: Sequence analysis of HBV, derived from 11 samples collected 2010-2020 from one patient, identified 12 non-synonymous single-nucleotide polymorphisms (SNPs) emerging during a tenofovir treatment interruption from 2014 to 2017. Two of the SNPs were in the reverse transcriptase (RT; H35Q and D263E). The two RT mutations were linked and persisted despite restarting tenofovir treatment in 2017. For the second patient, we analyzed HBV derived from six samples collected 2014-2020 following 10 years of tenofovir treatment, and identified five non-synonymous SNPs, that confer resistance towards entecavir and/or lamivudine. Two RT mutations (H35N and P237T) emerged during subsequent 5-year entecavir treatment. H35N was maintained during final tenofovir treatment. CONCLUSIONS: Our findings indicate that changes at the conserved residue 35 (H35N/Q) in the HBV RT may be associated with tenofovir resistance. These variants have not previously been described, and further studies are warranted to assess resistance in vitro and in vivo.


Assuntos
Hepatite B Crônica , Organofosfonatos , Adenina/efeitos adversos , Antivirais/farmacologia , Antivirais/uso terapêutico , DNA Viral/genética , Farmacorresistência Viral/genética , Vírus da Hepatite B/genética , Hepatite B Crônica/tratamento farmacológico , Humanos , Mutação , Organofosfonatos/uso terapêutico , DNA Polimerase Dirigida por RNA/genética , Tenofovir/farmacologia , Tenofovir/uso terapêutico , Viremia/tratamento farmacológico
17.
PLoS One ; 17(4): e0266717, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35421134

RESUMO

BACKGROUND: The growing access to mobile phones in Africa has led to an increase in mobile health interventions, including an increasing number of two-way text message interventions. However, their effect on healthcare outcomes in an African context is uncertain. This systematic review aims to landscape randomized trials involving two-way text message interventions and estimate their effect on healthcare outcomes. METHODS: We searched Medline, Embase, Cochrane Central Register of Controlled Trials, The Global Health Library (up to 12 August 2021) and trial registries (up to 24 April 2020). Published and unpublished trials conducted in Africa comparing two-way text message interventions with standard care and/or one-way text message interventions were included. Trials that reported dichotomous effect estimates on healthcare appointment attendance and/or medicine adherence were assessed for risk of bias and included in meta-analyses. Results of other outcomes were reported descriptively. RESULTS: We included 31 trials (28,563 participants) all set in Sub-Saharan Africa with a wide range of clinical conditions. Overall, ten different trials were included in the primary meta-analyses, and two of these had data on both medicine adherence and appointment attendance. An additional two trials were included in sensitivity analyses. Of the 12 included trials, three were judged as overall low risk of bias and nine as overall high risk of bias trials. Two-way text messages did not improve appointment attendance, RR: 1.03; 95% CI: 0.95-1.12, I2 = 53% (5 trials, 4374 participants) but improved medicine adherence compared to standard care, RR: 1.14, 95% CI: 1.07-1.21, I2 = 8% (6 trials, 2783 participants). CONCLUSION: Two-way text messages seemingly improve medicine adherence but has an uncertain effect on appointment attendance compared to standard care. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020175810.


Assuntos
Telefone Celular , Envio de Mensagens de Texto , Agendamento de Consultas , Atenção à Saúde , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
18.
Res Synth Methods ; 13(2): 214-228, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-34558198

RESUMO

Randomised trials are often funded by commercial companies and methodological studies support a widely held suspicion that commercial funding may influence trial results and conclusions. However, these studies often have a risk of confounding and reporting bias. The risk of confounding is markedly reduced in meta-epidemiological studies that compare fairly similar trials within meta-analyses, and risk of reporting bias is reduced with access to unpublished data. Therefore, we initiated the COMmercial Funding In Trials (COMFIT) study aimed at investigating the impact of commercial funding on estimated intervention effects in randomised clinical trials based on a consortium of researchers who agreed to share meta-epidemiological study datasets with information on meta-analyses and trials included in meta-epidemiological studies. Here, we describe the COMFIT study, its database, and descriptive results. We included meta-epidemiological studies with published or unpublished data on trial funding source and results or conclusions. We searched five bibliographic databases and other sources. We invited authors of eligible meta-epidemiological studies to join the COMFIT consortium and to share data. The final construction of the COMFIT database involves checking data quality, identifying trial references, harmonising variable categories, and removing non-informative meta-analyses as well as correlated meta-analyses and trial results. We included data from 17 meta-epidemiological studies, covering 728 meta-analyses and 6841 trials. Seven studies (405 meta-analyses, 3272 trials) had not published analyses on the impact of commercial funding, but shared unpublished data on funding source. On this basis, we initiated the construction of a combined database. Once completed, the database will enable comprehensive analyses of the impact of commercial funding on trial results and conclusions with increased statistical power and a markedly reduced risk of confounding and reporting bias.


Assuntos
Estudos Epidemiológicos , Viés
19.
Int J Health Policy Manag ; 11(8): 1274-1285, 2022 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-33812349

RESUMO

BACKGROUND: This systematic review aims to estimate the proportion of medical schools and teaching hospitals with conflicts of interest (COI) policies for health research and education, to describe the provisions included in the policies and their impact on research outputs and educational quality or content. METHODS: Experimental and observational studies reporting at least one of the above mentioned aims were included irrespective of language, publication type or geographical setting. MEDLINE, Scopus, Embase and the Cochrane Methodology Register were searched from inception to March 2020. Methodological study quality was assessed using an amended version of the Joanna Briggs Institute's checklist for prevalence studies. RESULTS: Twenty-two cross-sectional studies were included; all were conducted in high-income countries. Of these, 20 studies estimated the prevalence of COI policies, which ranged from 5% to 100% (median: 85%). Twenty studies assessed the provisions included in COI policies with different assessment methods. Of these, nine analysed the strength of the content of medical schools' COI policies using various assessment tools that looked at a range of policy domains. The mean standardised summary score of policy strength ranged from 2% to 73% (median: 30%), with a low score indicating a weak policy. North American institutions more frequently had COI policies and their content was rated as stronger than policies from European institutions. None of the included studies assessed the impact of COI policies on research outputs or educational quality or content. CONCLUSION: Prevalence of COI policies at medical schools and teaching hospitals varied greatly in high-income countries. No studies estimated the prevalence of policies in low to middle-income countries. The content of COI policies varied widely and while most European institutions ranked poorly, in North America more medical schools had strong policies. No studies were identified on impact of COI policies on research outputs and educational quality or content.


Assuntos
Conflito de Interesses , Faculdades de Medicina , Humanos , Estudos Transversais , Políticas , Hospitais de Ensino
20.
PLoS One ; 16(11): e0260544, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34843589

RESUMO

BACKGROUND: Effective drug treatments for Covid-19 are needed to decrease morbidity and mortality for the individual and to alleviate pressure on health care systems. Remdesivir showed promising results in early randomised trials but subsequently a large publicly funded trial has shown less favourable results and the evidence is interpreted differently in clinical guidelines. Systematic reviews of remdesivir have been published, but none have systematically searched for unpublished data, including regulatory documents, and assessed the risk of bias due to missing evidence. METHODS: We will conduct a systematic review of randomised trials comparing remdesivir to placebo or standard of care in any setting. We will include trials regardless of the severity of disease and we will include trials examining remdesivir for indications other than Covid-19 for harms analyses. We will search websites of regulatory agencies, trial registries, bibliographic databases, preprint servers and contact trial sponsors to obtain all available data, including unpublished clinical data, for all eligible trials. Our primary outcomes will be all-cause mortality and serious adverse events. Our secondary outcomes will be length of hospital stay, time to death, severe disease, and adverse events. We will assess the risk of bias using the Cochranes Risk of Bias 2 tool and the risk of bias due to missing evidence (e.g. publication bias, selective reporting bias) using the ROB-ME tool. Where appropriate we will synthesise study results by conducting random-effects meta-analysis. We will present our findings in a Summary of Findings table and rate the certainty of the evidence using the GRADE approach. DISCUSSION: By conducting a comprehensive systematic review including unpublished data (where available), we expect to be able to provide valuable information for patients and clinicians about the benefits and harms of remdesivir for the treatment of Covid-19. This will help to ensure optimal treatment for individual patients and optimal utilisation of health care resources. SYSTEMATIC REVIEW REGISTRATION: CRD42021255915.


Assuntos
Monofosfato de Adenosina/análogos & derivados , Alanina/análogos & derivados , Tratamento Farmacológico da COVID-19 , Monofosfato de Adenosina/uso terapêutico , Adulto , Alanina/uso terapêutico , Humanos , Viés de Publicação , Risco
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