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1.
PLoS One ; 14(11): e0222077, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31693665

RESUMO

OBJECTIVES: To investigate the consistency of adverse events (AEs) and adverse drug reactions (ADRs) reported in the literature, monitoring and social media data. METHODS: Using one Chinese patent medicine-Cordyceps sinensis extracts (CSE) as an example, we obtained safety data from the national monitoring system (July 2002 to February 2016), literature (up to November 2016) and social media (May 2019). For literature data, we searched the Chinese National Knowledge Infrastructure Database (CNKI), WanFang database, Chinese Science and Technology Periodical Database (VIP), Chinese Biomedical Literature Database (SinoMed), PubMed, Embase and the Cochrane Library. Social media data was from the Baidu post bar and Sina micro-blog. Two authors independently screened the literature and extracted data by PRISMA Harms checklist was followed. AEs and ADRs were coded using the World Health Organization Adverse Reaction Terminology (WHO-ART). AEs and ADRs were grouped into thirty-one organ-system classes for comparisons. Frequencies, relative frequencies and rank were used as metrics. Radar chart was used to manifest the features of the distributions and proportions. RESULTS: 610 AEs reported in CFDA monitoring data were associated with CSE, of which 537 (88.03%) were suspected ADRs (10.49% certain). 5568 AEs were identified from 172 papers (63% RCTs, 37% other types of studies including case series, case reports, ADR monitoring reports and reviews), in which 86 (1.54%) were ADRs (1.54% certain). 15 AEs (0 certain ADR) were identified from social media. AEs, ADRs and their affected system-organ classes, looked largely similar, but different in every aspect when looking at details. Data from RCTs demonstrated the most disparity. CONCLUSIONS: In our study, the most prevalent AEs and ADRs, mainly gastro-intestinal system disorders including nausea, diarrhea and vomiting, in monitoring system were largely similar with those in literature and social media. But data from different sources varied if looked at details. Multiple data sources (the monitoring system, literature and social media) should be integrated to collect safety information of interventions. The distributions of AEs and ADRs from RCTs were least similar with the data from other sources. Our empirical proof is consistent with other similar studies.

2.
BMC Cardiovasc Disord ; 19(1): 256, 2019 Nov 14.
Artigo em Inglês | MEDLINE | ID: mdl-31726981

RESUMO

BACKGROUND: Depression is associated with increased mortality and poor prognosis in patients with cardiovascular disease (CVD). However, little is known about the patient characteristics associated with new onset post heart event depressive symptoms, specifically medical comorbidities, among cardiac rehabilitation (CR) participants. Therefore, this paper examines the comorbidity profile and characteristics associated with new onset depressive symptoms in patients attending CR. METHODS: An observational study using the routine practice data of British Heart Foundation National Audit of Cardiac Rehabilitation (NACR) from the last six years between April 2012 and March 2018. Patients with new onset post heart event depression and no previous documented history of depression were selected as the study population. An independent samples t-test and chi square tests were used to compare the association between new onset depressive symptoms and patient variables including demographics, clinical measures and comorbidities. A binary logistic regression was conducted to investigate the predictors of new onset depressive symptoms employing log-likelihood ratio statistic. RESULTS: The analyses included 109,055 CR patients with new onset depression measured by Hospital Anxiety and Depression Scale (HADS). At baseline assessment, comorbidity measures associated with new onset depressive symptoms were increased total number of comorbidities and a range of comorbidities - including diabetes, angina, arthritis, chronic back problems, asthma, stroke, anxiety, rheumatism, claudication, osteoporosis, chronic bronchitis and emphysema. After multivariate adjustments were done, at the start of CR, the significant predictors of new onset depressive symptoms were physical inactivity, high HADS anxiety score measurement, increased weight, total number of comorbidities, diabetes, stroke, chronic back problems, being from areas with higher levels of social deprivation, being single, and male. CONCLUSION: The research findings establish new insights into the association between patient demographic and clinical variables across a range of comorbidities in patients with new onset post heart event depressive symptoms. At the start of CR, patients with new onset depressive symptoms need to be assessed skilfully as they tend to have a complex multi-morbid presentation linked to psychosocial risk factors known to hinder CR engagement.

3.
J Med Internet Res ; 21(8): e7081, 2019 Aug 29.
Artigo em Inglês | MEDLINE | ID: mdl-31469079

RESUMO

BACKGROUND: Adverse events are underreported in research studies, particularly randomized controlled trials and pharmacovigilance studies. A method that researchers could use to identify more complete safety profiles for medications is to use social media analytics. However, patient's perspectives on the ethical issues associated with using patient reports of adverse drug events on social media are unclear. OBJECTIVE: The objective of this study was to explore the ethics of using social media for detecting and monitoring adverse events for research purposes using a multi methods approach. METHODS: A multi methods design comprising qualitative semistructured interviews (n=24), a focus group (n=3), and 3 Web-based discussions (n=20) with members of the public was adopted. Findings from a recent systematic review on the use of social media for monitoring adverse events provided a theoretical framework to interpret the study's findings. RESULTS: Views were ascertained regarding the potential benefits and harms of the research, privacy expectations, informed consent, and social media platform. Although the majority of participants were supportive of social media content being used for research on adverse events, a small number of participants strongly opposed the idea. The potential benefit of the research was cited as the most influential factor to whether participants would give their consent to their data being used for research. There were also some caveats to people's support for the use of their social media data for research purposes: the type of social media platform and consideration of the vulnerability of the social media user. Informed consent was regarded as difficult to obtain and this divided the opinion on whether it should be sought. CONCLUSIONS: Social media users were generally positive about their social media data being used for research purposes; particularly for research on adverse events. However, approval was dependent on the potential benefit of the research and that individuals are protected from harm. Further study is required to establish when consent is required for an individual's social media data to be used.

4.
BMJ Open ; 9(6): e029690, 2019 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-31201194

RESUMO

OBJECTIVES: On 1 May 2018 minimum unit pricing (MUP) of alcohol was introduced in Scotland. This study used Twitter posts to quantify sentiment expressed online during the introduction of MUP, conducted a thematic analysis of these perceptions and analysed which Twitter users were associated with which particular sentiments. DESIGN AND SETTING: This qualitative social media analysis captured all tweets relating to MUP during the 2 weeks after the introduction of the policy. These tweets were assessed using a mixture of human and machine coding for relevance, sentiment and source. A thematic analysis was conducted. PARTICIPANTS: 74 639 tweets were collected over 14 days. Of these 53 574 were relevant to MUP. RESULTS: Study findings demonstrate that opinion on the introduction of MUP in Scotland was somewhat divided, as far as is discernible on Twitter, with a slightly higher proportion of positive posts (35%) than negative posts (28%), with positive sentiment stronger in Scotland itself. Furthermore, 55% of positive tweets/retweets were originally made by health or alcohol policy-related individuals or organisations. Thematic analysis of tweets showed some evidence of misunderstanding around policy issues. CONCLUSIONS: It is possible to appreciate the divided nature of public opinion on the introduction of MUP in Scotland using Twitter, the nature of the sentiment around it and the key actors involved. It will be possible to later study how this changes when the policy becomes more established.

5.
Health Info Libr J ; 36(3): 244-263, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31187590

RESUMO

BACKGROUND: Objectively derived search filters for adverse drug effects and complications in surgery have been developed but not for medical device adverse effects. OBJECTIVE: To develop and validate search filters to retrieve evidence on medical device adverse effects from ovid medline and embase. METHODS: We identified systematic reviews from Epistemonikos and the Health Technology Assessment (hta) database. Included studies within these reviews that reported on medical device adverse effects were randomly divided into three test sets and one validation set of records. Using word frequency analysis from one test set, we constructed a sensitivity maximising search strategy. This strategy was refined using two other test sets, then validated. RESULTS: From 186 systematic reviews which met our inclusion criteria, 1984 unique included studies were available from medline and 1986 from embase. Generic adverse effects searches in medline and embase achieved 84% and 83% sensitivity. Recall was improved to over 90%, however, when specific adverse effects terms were added. CONCLUSION: We have derived and validated novel search filters that retrieve over 80% of records with medical device adverse effects data in medline and embase. The addition of specific adverse effects terms is required to achieve higher levels of sensitivity.

6.
Open Heart ; 6(1): e000973, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31168379

RESUMO

Background: A prior history of depression, at the point patients start cardiac rehabilitation (CR), is associated with poor outcomes; however, little is known about which factors play a part in determining the extent of benefit following CR. Therefore, we aim to identify and evaluate determinants of CR depression outcomes in patients with comorbid depression. Methods: An observational study of routine practice using the British Heart Foundation National Audit of Cardiac Rehabilitation data between April 2012 and March 2017. Baseline characteristics were examined with independent samples t-test and χ2 test. A binary logistic regression was used to predict change in depression outcome following CR. Results: The analysis included 2715 CR participants with depression history. The determinants of Hospital Anxiety and Depression Scale (HADS) depression measurement post-CR were higher total number of comorbidities (OR 0.914, 95% CI 0.854 to 0.979), a higher HADS anxiety score (OR 0.883, 95% CI 0.851 to 0.917), physical inactivity (OR 0.707, 95% CI 0.514 to 0.971), not-smoking at baseline (OR 1.774, 95% CI 1.086 to 2.898) and male gender (OR 0.721, 95% CI 0.523 to 0.992). Conclusion: Baseline characteristics of patients with comorbid depression such as higher anxiety, higher total number of comorbidities, smoking, physical inactivity and male gender were predictors of their depression levels following CR. CR programmes need to be aware of comorbid depression and these related patient characteristics associated with better CR outcomes.

7.
J Clin Epidemiol ; 113: 36-43, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31150833

RESUMO

OBJECTIVES: Methodological research has been undertaken to investigate the many challenges in searching for adverse effects data. It is imperative that the search approach adopted in systematic reviews is based on the best available evidence. We provide a detailed summary of the results and implications of the current evidence base to assist future searches for adverse effects. STUDY DESIGN AND SETTING: This article is a narrative review from the authors of the Cochrane Handbook chapter on adverse effects. RESULTS: The specified search strategy must be based on the population, intervention, comparator, outcome(s) format for question formulation and appropriate study designs for adverse effects data. Search filters and suggested search terms are available for the adverse effects of drug, medical devices, and surgical interventions. The use of generic adverse effects terms (such as harms and complications) as text words and indexing terms and specific adverse effects terms (such as rash and wound infection) are warranted. Searching databases beyond MEDLINE has proven useful, as well as the use of nondatabase sources. CONCLUSION: This article provides the most up-to-date evidence-based guidance in identifying adverse effects data in the literature. It will support searchers and researchers evaluating the potential for harm of medical interventions in systematic reviews.

8.
Drug Saf ; 42(3): 389-400, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30284214

RESUMO

INTRODUCTION: Adverse effects of medications taken during pregnancy are traditionally studied through post-marketing pregnancy registries, which have limitations. Social media data may be an alternative data source for pregnancy surveillance studies. OBJECTIVE: The objective of this study was to assess the feasibility of using social media data as an alternative source for pregnancy surveillance for regulatory decision making. METHODS: We created an automated method to identify Twitter accounts of pregnant women. We identified 196 pregnant women with a mention of a birth defect in relation to their baby and 196 without a mention of a birth defect in relation to their baby. We extracted information on pregnancy and maternal demographics, medication intake and timing, and birth defects. RESULTS: Although often incomplete, we extracted data for the majority of the pregnancies. Among women that reported birth defects, 35% reported taking one or more medications during pregnancy compared with 17% of controls. After accounting for age, race, and place of residence, a higher medication intake was observed in women who reported birth defects. The rate of birth defects in the pregnancy cohort was lower (0.44%) compared with the rate in the general population (3%). CONCLUSIONS: Twitter data capture information on medication intake and birth defects; however, the information obtained cannot replace pregnancy registries at this time. Development of improved methods to automatically extract and annotate social media data may increase their value to support regulatory decision making regarding pregnancy outcomes in women using medications during their pregnancies.

9.
J Clin Epidemiol ; 108: 95-101, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30553831

RESUMO

OBJECTIVES: The aim of the study was to assess the risk for adverse events reporting bias in systematic reviews of health care interventions registered to PROSPERO. STUDY DESIGN AND SETTING: This study was a retrospective cohort study. Systematic review protocols in PROSPERO were screened and included if they focused on a health care intervention and listed an adverse event as either a primary or secondary outcome. The included systematic reviews were assessed to determine the completeness of reporting for the adverse event outcomes. Any discrepancies in reporting between protocol and review were recorded. RESULTS: Of 1,376 protocols for systematic reviews sifted, only 524 (38%) listed adverse events outcomes. One hundred eighty-six protocols were published in 2017 and 2018, of which 146 were included in our analysis. Among the included systematic reviews, 65% (95/146) fully reported the adverse event outcomes as intended by the protocol, 8% (12/146) entirely excluded the adverse event outcome, and the remaining 27% (39/146) either partially reported or changed the adverse event outcomes. CONCLUSION: Sixty-two percent of reviews did not mention adverse events in their protocol, and 35% of PROSPERO-registered systematic reviews had discrepant outcome reporting between the protocol and publication. The findings suggest a need for the encouraged use of harms reporting guidelines and further research into adverse events reporting bias.

10.
BMC Cardiovasc Disord ; 18(1): 230, 2018 12 10.
Artigo em Inglês | MEDLINE | ID: mdl-30526515

RESUMO

BACKGROUND: The literature suggests that comorbid depression, defined in this paper as a history of depression prior to a cardiovascular event, has an impact on later onset depression as well as constituting increased risk of mortality and adverse cardiac events. However, which factors are associated with depression, specifically in patients with comorbid depression, is unclear. Therefore, this paper investigates the factors associated with depression in patients with comorbid depression attending cardiac rehabilitation (CR). METHODS: This observational study used routinely collected data from the British Heart Foundation National Audit of Cardiac Rehabilitation for the time period between April 2012 and March 2017. CR participants with comorbid depression were selected as the study population. An independent t-test and chi-square test were used to compare the association between acute depression symptoms and baseline characteristics in this population. RESULTS: A total of 2715 CR patients with comorbid depression were analysed. Characteristics associated with acute depressive symptoms in patients with comorbid depression were found to be: young age (MD: 2.71, 95% CI 1.91, 3.50), increased number of comorbidities (MD: -0.50, 95% CI -0.66, - 0.34), increased weight (MD: -1.94, 95% CI -3.35, - 0.52), high BMI (MD: -1.94, 95% CI -3.35, - 0.52), HADS anxiety (MD: -5.17, 95% CI -5.47, - 4.87), comorbid anxiety (52.4%, p <  0.001), physical inactivity (150 min moderate physical activity a week and 75 min vigorous exercise a week; 27.5%, p <  0.001; 5.6%, p <  0.001 respectively), smoking (12.7%, p <  0.001), and being less likely to be partnered (63.6%, p <  0.001). CONCLUSION: The study demonstrated the association between a variety of clinical and socio-demographic factors and depression. The findings of the research indicated that, at CR baseline assessment, caution must be taken with patients with comorbid depression, specifically those with higher level depressive symptoms at the start of rehabilitation. Furthermore, their multi-comorbid condition must also be taken into account. Patients with higher depression symptoms and comorbid depression scored five points higher on the HADS anxiety scale in comparison to patients with lower level depression symptoms at the start of CR, which demonstrated that anxiety and depression are interrelated and present together.


Assuntos
Reabilitação Cardíaca , Depressão/psicologia , Cardiopatias/reabilitação , Fatores Etários , Idoso , Ansiedade/epidemiologia , Ansiedade/psicologia , Comorbidade , Depressão/diagnóstico , Depressão/epidemiologia , Feminino , Cardiopatias/diagnóstico , Cardiopatias/epidemiologia , Cardiopatias/fisiopatologia , Humanos , Masculino , Estado Civil , Pessoa de Meia-Idade , Obesidade/epidemiologia , Medição de Risco , Fatores de Risco , Comportamento Sedentário , Fumar/efeitos adversos , Fumar/epidemiologia , Fatores de Tempo , Resultado do Tratamento , Reino Unido/epidemiologia
11.
BMC Med Res Methodol ; 18(1): 106, 2018 10 12.
Artigo em Inglês | MEDLINE | ID: mdl-30314471

RESUMO

BACKGROUND: Health inequalities, worse health associated with social and economic disadvantage, are reported by a minority of research articles. Locating these studies when conducting an equity-focused systematic review is challenging due to a deficit in standardised terminology, indexing, and lack of validated search filters. Current reporting guidelines recommend not applying filters, meaning that increased resources are needed at the screening stage. METHODS: We aimed to design and test search filters to locate studies that reported outcomes by a social determinant of health. We developed and expanded a 'specific terms strategy' using keywords and subject headings compiled from recent systematic reviews that applied an equity filter. A 'non-specific strategy' was compiled from phrases used to describe equity analyses that were reported in titles and abstracts, and related subject headings. Gold standard evaluation and validation sets were compiled. The filters were developed in MEDLINE, adapted for Embase and tested in both. We set a target of 0.90 sensitivity (95% CI; 0.84, 0.94) in retrieving 150 gold standard validation papers. We noted the reduction in the number needed to screen in a proposed equity-focused systematic review and the proportion of equity-focused reviews we assessed in the project that applied an equity filter to their search strategy. RESULTS: The specific terms strategy filtered out 93-95% of all records, and retrieved a validation set of articles with a sensitivity of 0.84 in MEDLINE (0.77, 0.89), and 0.87 (0.81, 0.92) in Embase. When combined (Boolean 'OR') with the non-specific strategy sensitivity was 0.92 (0.86, 0.96) in MEDLINE (Embase 0.94; 0.89, 0.97). The number needed to screen was reduced by 77% by applying the specific terms strategy, and by 59.7% (MEDLINE) and 63.5% (Embase) by applying the combined strategy. Eighty-one per cent of systematic reviews filtered studies by equity. CONCLUSIONS: A combined approach of using specific and non-specific terms is recommended if systematic reviewers wish to filter studies for reporting outcomes by social determinants. Future research should concentrate on the indexing standardisation for equity studies and further development and testing of both specific and non-specific terms for accurate study retrieval.


Assuntos
Bases de Dados Bibliográficas/normas , Equidade em Saúde/normas , Disparidades em Assistência à Saúde/normas , MEDLINE/normas , Ferramenta de Busca/normas , Bases de Dados Bibliográficas/estatística & dados numéricos , Guias como Assunto/normas , Equidade em Saúde/estatística & dados numéricos , Recursos em Saúde/normas , Recursos em Saúde/estatística & dados numéricos , Disparidades em Assistência à Saúde/estatística & dados numéricos , Humanos , MEDLINE/estatística & dados numéricos , Registros/normas , Registros/estatística & dados numéricos , Padrões de Referência , Ferramenta de Busca/métodos , Ferramenta de Busca/estatística & dados numéricos , Revisão Sistemática como Assunto
12.
BMJ Evid Based Med ; 23(6): 210-217, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30309870

RESUMO

Reporting bias is a major threat to the validity and credibility of systematic reviews. This article outlines the rationale for accessing clinical study reports and other regulatory documents (regulatory data) as a means of addressing reporting bias and identifies factors that may help decide whether (or not) to include regulatory data in systematic reviews. The article also describes the origins and current state of regulatory data access and summarises a survey of current systematic reviewers' practices in considering regulatory data for inclusion in systematic reviews. How to access and extract regulatory data is not addressed. Organisations and other stakeholders such as Cochrane should encourage the use of data from clinical study reports as an important source of data in reviews of pharmaceutical interventions particularly when the intervention in question is of high importance and the risk of reporting bias is great.


Assuntos
Medicina Baseada em Evidências/métodos , Relatório de Pesquisa , Revisão Sistemática como Assunto , Viés , Humanos , Projetos de Pesquisa
13.
Drug Saf ; 41(12): 1397-1410, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30167992

RESUMO

INTRODUCTION: Adverse drug reactions (ADRs) are associated with significant health-related and financial burden, and multiple sources are currently utilized to actively discover them. Social media has been proposed as a potential resource for monitoring ADRs, but drug-specific analytical studies comparing social media with other sources are scarce. OBJECTIVES: Our objective was to develop methods to compare ADRs mentioned in social media with those in traditional sources: the US FDA Adverse Event Reporting System (FAERS), drug information databases (DIDs), and systematic reviews. METHODS: A total of 10,188 tweets mentioning adalimumab collected between June 2014 and August 2016 were included. ADRs in the corpus were extracted semi-automatically and manually mapped to standardized concepts in the Unified Medical Language System. ADRs were grouped into 16 biologic categories for comparisons. Frequencies, relative frequencies, disproportionality analyses, and rank ordering were used as metrics. RESULTS: There was moderate agreement between ADRs in social media and traditional sources. "Local and injection site reactions" was the top ADR in Twitter, DIDs, and systematic reviews by frequency, ranked frequency, and index ranking. The next highest ADR in Twitter-fatigue-ranked fifth and seventh in FAERS and DIDs. CONCLUSION: Social media posts often express mild and symptomatic ADRs, but rates are measured differently in scientific sources. ADRs in FAERS are reported as absolute numbers, in DIDs as percentages, and in systematic reviews as percentages, risk ratios, or other metrics, which makes comparisons challenging; however, overlap is substantial. Social media analysis facilitates open-ended investigation of patient perspectives and may reveal concepts (e.g. anxiety) not available in traditional sources.


Assuntos
Adalimumab/efeitos adversos , Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Bases de Dados de Produtos Farmacêuticos/normas , Estudo de Prova de Conceito , Mídias Sociais/normas , United States Food and Drug Administration/normas , Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Anti-Inflamatórios/efeitos adversos , Bases de Dados de Produtos Farmacêuticos/tendências , Humanos , Mídias Sociais/tendências , Revisão Sistemática como Assunto , Estados Unidos/epidemiologia , United States Food and Drug Administration/tendências
14.
Syst Rev ; 7(1): 117, 2018 08 08.
Artigo em Inglês | MEDLINE | ID: mdl-30089508

RESUMO

BACKGROUND: Clinical study reports (CSRs) are produced for marketing authorisation applications. They often contain considerably more information about, and data from, clinical trials than corresponding journal publications. Use of data from CSRs might help circumvent reporting bias, but many researchers appear to be unaware of their existence or potential value. Our survey aimed to gain insight into the level of familiarity, understanding and use of CSRs, and to raise awareness of their potential within the systematic review community. We also aimed to explore the potential barriers faced when obtaining and using CSRs in systematic reviews. METHODS: Online survey of systematic reviewers who (i) had requested or used CSRs, (ii) had considered but not used CSRs and (iii) had not considered using CSRs was conducted. Cochrane reviewers were contacted twice via the Cochrane monthly digest. Non-Cochrane reviewers were reached via journal and other website postings. RESULTS: One hundred sixty respondents answered an open invitation and completed the questionnaire; 20/160 (13%) had previously requested or used CSRs and other regulatory documents, 7/160 (4%) had considered but not used CSRs and 133/160 (83%) had never considered this data source. Survey respondents mainly sought data from the European Medicines Agency (EMA) and/or the Food and Drug Administration (FDA). Motivation for using CSRs stemmed mainly from concerns about reporting bias 11/20 (55%), specifically outcome reporting bias 11/20 (55%) and publication bias 5/20 (25%). The barriers to using CSRs noted by all types of respondents included current limited access to these documents (43 respondents), the time and resources needed to obtain and include these data in evidence syntheses (n = 25) and lack of guidance about how to use these sources in systematic reviews (n = 26). CONCLUSIONS: Most respondents (irrespective of whether they had previously used them) agreed that access to CSRs is important, and suggest that further guidance on how to use and include these data would help to promote their use in future systematic reviews. Most respondents who received CSRs considered them to be valuable in their systematic review and/or meta-analysis.


Assuntos
Autoria , Viés de Publicação , Relatório de Pesquisa , Revisão Sistemática como Assunto , Humanos , Inquéritos e Questionários
15.
Drug Saf ; 41(10): 933-938, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-29737504

RESUMO

INTRODUCTION: Reporting of harms in randomized control trials is often inconsistent and inadequate. OBJECTIVE: To assess the quality of harms reporting in randomized control trials evaluating the efficacy of antibiotics used to treat pediatric acute otitis media and to investigate whether connections to pharmaceutical companies or the publication of the CONSORT-Harms extension influenced the quality of harms reporting. STUDY DESIGN AND SETTING: We considered randomized control trials that evaluated the efficacy and safety of antibiotic treatment for uncomplicated acute otitis media in children aged 0-19. We evaluated the quality of harms reporting using a 19-item checklist addressing the recommendations endorsed in the CONSORT-Harms extension. RESULTS: 160 studies met our inclusion criteria. Overall quality of reporting relating to harms was low; on average studies adhered to 55.2% of the checklist items on the quality of harms reporting. The reporting of methods relating the measurement of harms was particularly lacking; studies adhered to an average of only 33.2% of the checklist items. The overall quality of reporting did not change after the publication of the CONSORT-Harms extension. The overall quality of reporting did not differ significantly in reports with or without declared connections to pharmaceutical companies (mean quality score of 56.8% vs 52.0%, respectively). CONCLUSIONS: Harms reporting in pediatric randomized trials, especially the reporting of methods used to collect harms data, remains inadequate.


Assuntos
Antibacterianos/administração & dosagem , Otite Média/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Doença Aguda , Adolescente , Antibacterianos/efeitos adversos , Lista de Checagem , Criança , Pré-Escolar , Humanos , Lactente , Recém-Nascido , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Adulto Jovem
16.
Health Info Libr J ; 35(2): 121-129, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29603850

RESUMO

BACKGROUND: Search filter development for adverse effects has tended to focus on retrieving studies of drug interventions. However, a different approach is required for surgical interventions. OBJECTIVE: To develop and validate search filters for medline and Embase for the adverse effects of surgical interventions. METHODS: Systematic reviews of surgical interventions where the primary focus was to evaluate adverse effect(s) were sought. The included studies within these reviews were divided randomly into a development set, evaluation set and validation set. Using word frequency analysis we constructed a sensitivity maximising search strategy and this was tested in the evaluation and validation set. RESULTS: Three hundred and fifty eight papers were included from 19 surgical intervention reviews. Three hundred and fifty two papers were available on medline and 348 were available on Embase. Generic adverse effects search strategies in medline and Embase could achieve approximately 90% relative recall. Recall could be further improved with the addition of specific adverse effects terms to the search strategies. CONCLUSION: We have derived and validated a novel search filter that has reasonable performance for identifying adverse effects of surgical interventions in medline and Embase. However, we appreciate the limitations of our methods, and recommend further research on larger sample sizes and prospective systematic reviews.


Assuntos
Erros Médicos/tendências , Ferramenta de Busca/métodos , Procedimentos Cirúrgicos Operatórios/normas , Humanos , Armazenamento e Recuperação da Informação/métodos , Erros Médicos/mortalidade
17.
Res Synth Methods ; 8(4): 506-513, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28960807

RESUMO

Authors and indexers are increasingly including terms for adverse drug effects in the titles, abstracts, or indexing of records in MEDLINE and Embase. However, it is not clear if this is the same for studies with nondrug adverse effects data. We therefore assessed the feasibility of using adverse effects terms when searching MEDLINE or Embase to retrieve papers of nondrug adverse effects. A collection of papers that reported data on nondrug adverse effects was sought from included studies of systematic reviews. Each included study was analysed to ascertain whether the corresponding record in MEDLINE and Embase included adverse effects terms in the title, abstract, or indexing. From 9129 records screened from DARE, 30 reviews evaluating nondrug adverse effects met our inclusion criteria. From these, 635 unique papers were included in our analysis. Sensitive searches for adverse effects required generic and specific named adverse effects terms using the title, abstract, and indexing. Records relating to surgical interventions were more likely to contain adverse effects terms than records relating to nonsurgical interventions. Using any adverse effects terms in the title, abstract or indexing in MEDLINE and Embase would have identified an average of 94% of papers on surgical adverse effect interventions per systematic review and 72% of papers on nonsurgical adverse effects per systematic review. Hence, while a generic nondrug adverse effect search filter may not yet be feasible, a filter for the adverse effects of surgical interventions may be within reach.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Projetos de Pesquisa , Literatura de Revisão como Assunto , Procedimentos Cirúrgicos Operatórios/estatística & dados numéricos , Bases de Dados Bibliográficas , Humanos , Armazenamento e Recuperação da Informação , MEDLINE , Reprodutibilidade dos Testes , Sensibilidade e Especificidade
19.
J Med Internet Res ; 19(6): e195, 2017 06 06.
Artigo em Inglês | MEDLINE | ID: mdl-28588006

RESUMO

BACKGROUND: Although primarily used for social networking and often used for social support and dissemination, data on social media platforms are increasingly being used to facilitate research. However, the ethical challenges in conducting social media research remain of great concern. Although much debated in the literature, it is the views of the public that are most pertinent to inform future practice. OBJECTIVE: The aim of our study was to ascertain attitudes on the ethical considerations of using social media as a data source for research as expressed by social media users and researchers. METHODS: A systematic review was conducted, wherein 16 databases and 2 Internet search engines were searched in addition to handsearching, reference checking, citation searching, and contacting authors and experts. Studies that conducted any qualitative methods to collect data on attitudes on the ethical implications of research using social media were included. Quality assessment was conducted using the quality of reporting tool (QuaRT) and findings analyzed using inductive thematic synthesis. RESULTS: In total, 17 studies met the inclusion criteria. Attitudes varied from overly positive with people expressing the views about the essential nature of such research for the public good, to very concerned with views that social media research should not happen. Underlying reasons for this variation related to issues such as the purpose and quality of the research, the researcher affiliation, and the potential harms. The methods used to conduct the research were also important. Many respondents were positive about social media research while adding caveats such as the need for informed consent or use restricted to public platforms only. CONCLUSIONS: Many conflicting issues contribute to the complexity of good ethical practice in social media research. However, this should not deter researchers from conducting social media research. Each Internet research project requires an individual assessment of its own ethical issues. Guidelines on ethical conduct should be based on current evidence and standardized to avoid discrepancies between, and duplication across, different institutions, taking into consideration different jurisdictions.


Assuntos
Internet/estatística & dados numéricos , Projetos de Pesquisa/tendências , Mídias Sociais/ética , Atitude , Humanos , Rede Social
20.
BMC Med Res Methodol ; 17(1): 84, 2017 Jun 02.
Artigo em Inglês | MEDLINE | ID: mdl-28577540

RESUMO

BACKGROUND: Many medicines are dosed to achieve a particular therapeutic range, and monitored using therapeutic drug monitoring (TDM). The evidence base for a therapeutic range can be evaluated using systematic reviews, to ensure it continues to reflect current indications, doses, routes and formulations, as well as updated adverse effect data. There is no consensus on the optimal methodology for systematic reviews of therapeutic ranges. METHODS: An overview of systematic reviews of therapeutic ranges was undertaken. The following databases were used: Cochrane Database of Systematic Reviews (CDSR), Database of Abstracts and Reviews of Effects (DARE) and MEDLINE. The published methodologies used when systematically reviewing the therapeutic range of a drug were analyzed. Step by step recommendations to optimize such systematic reviews are proposed. RESULTS: Ten systematic reviews that investigated the correlation between serum concentrations and clinical outcomes encompassing a variety of medicines and indications were assessed. There were significant variations in the methodologies used (including the search terms used, data extraction methods, assessment of bias, and statistical analyses undertaken). Therapeutic ranges should be population and indication specific and based on clinically relevant outcomes. Recommendations for future systematic reviews based on these findings have been developed. CONCLUSION: Evidence based therapeutic ranges have the potential to improve TDM practice. Current systematic reviews investigating therapeutic ranges have highly variable methodologies and there is no consensus of best practice when undertaking systematic reviews in this field. These recommendations meet a need not addressed by standard protocols.


Assuntos
Monitoramento de Medicamentos/métodos , Medicina Baseada em Evidências , Preparações Farmacêuticas/administração & dosagem , Literatura de Revisão como Assunto , Relação Dose-Resposta a Droga , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/sangue , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Humanos , /métodos , Preparações Farmacêuticas/sangue
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