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Journal of Clinical Epidemiology

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https://www.readbyqxmd.com/read/29242095/cochrane-qualitative-and-implementation-methods-group-guidance-paper-4-methods-for-integrating-qualitative-and-implementation-evidence-within-intervention-effectiveness-reviews
#1
Angela Harden, James Thomas, Margaret Cargo, Janet Harris, Tomas Pantoja, Kate Flemming, Andrew Booth, Ruth Garside, Karin Hannes, Jane Noyes
The Cochrane Qualitative and Implementation Methods Group (CQIMG) develops and publishes guidance on the synthesis of qualitative and mixed-method evidence from process evaluations. Despite a proliferation of methods for the synthesis of qualitative research, less attention has focused on how to integrate these syntheses within intervention effectiveness reviews. In this paper we report updated guidance from the group on approaches, methods and tools which can be used to integrate the findings from quantitative studies evaluating intervention effectiveness with those from qualitative studies and process evaluations...
December 11, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29242094/cochrane-qualitative-and-implementation-methods-group-guidance-series-paper-1-introduction
#2
Jane Noyes, Andrew Booth, Margaret Cargo, Kate Flemming, Ruth Garside, Karin Hannes, Angela Harden, Janet Harris, Simon Lewin, Tomas Pantoja, James Thomas
No abstract text is available yet for this article.
December 11, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29223325/cochrane-qualitative-and-implementation-methods-group-guidance-paper-3-methods-for-assessing-evidence-on-intervention-implementation
#3
Margaret Cargo, Janet Harris, Tomas Pantoja, Andrew Booth, Angela Harden, Karin Hannes, James Thomas, Kate Flemming, Ruth Garside, Jane Noyes
OBJECTIVE: This article provides reviewers with guidance on methods for identifying and processing evidence to understand intervention implementation. STUDY DESIGN AND SETTING: Strategies, tools and methods are applied to the systematic review process to illustrate how process and implementation can be addressed using quantitative, qualitative and other sources of evidence (i.e., descriptive textual, non-empirical). RESULTS: Reviewers can take steps to navigate the heterogeneity and level of uncertainty present in the concepts, measures and methods used to assess implementation...
December 6, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29222061/differences-between-protocols-for-randomized-controlled-trials-and-systematic-reviews
#4
Dawid Pieper, Katharina Allers
No abstract text is available yet for this article.
December 5, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29222060/cochrane-qualitative-and-implementation-methods-group-guidance-paper-5-reporting-guidelines-for-qualitative-implementation-and-process-evaluation-evidence-syntheses
#5
Kate Flemming, Andrew Booth, Karin Hannes, Margaret Cargo, Jane Noyes
OBJECTIVE: To outline contemporary and novel developments for presentation and reporting of syntheses of qualitative, implementation and process evaluation evidence, and provide recommendations for use of reporting guidelines. STUDY DESIGN AND SETTING: An overview of reporting guidelines for qualitative, implementation and process evaluation evidence syntheses drawing on current international literature and the collective expert knowledge of the Cochrane Qualitative and Implementation Methods Group...
December 5, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29222059/some-cochrane-risk-of-bias-items-are-not-important-in-osteoarthritis-trials-a-meta-epidemiological-study-based-on-cochrane-reviews
#6
REVIEW
Julie Bolvig, Carsten B Juhl, Isabelle Boutron, Peter Tugwell, Elizabeth A T Ghogomu, Jordi Pardo Pardo, Tamara Rader, George A Wells, Alain Mayhew, Lara Maxwell, Hans Lund, Henning Bliddal, Robin Christensen
OBJECTIVE: To evaluate the impact of bias-related study characteristics on treatment effects in osteoarthritis (OA) trials. STUDY DESIGN: Based on OA trials included in Cochrane reviews the impact of study characteristics on treatment effect estimates were evaluated. Characteristics included items of the risk of bias tool (RoB), trial size, single vs multi-site, and source of funding. Effect sizes were calculated as standardized mean differences (SMDs). Meta-regression was performed to identify "relevant study-level covariates" that decreases the between-study variance (τˆ2)...
December 5, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29217452/specific-agreement-on-ordinal-and-multiple-nominal-outcomes-can-be-calculated-for-more-than-two-raters
#7
Henrica C W de Vet, Margriet G Mullender, Iris Eekhout
OBJECTIVE: The concept of specific agreement has been proposed for dichotomous outcomes for two and more raters. We aim to extend this concept for variables with more than two ordinal or nominal categories and more than two raters. STUDY DESIGN AND SETTING: We used two data sets: 4 plastic surgeons classifying photographs after breast reconstruction on a 5 point ordinal scale; and 6 raters classifying psychiatric patients into 5 diagnostic categories. For m raters, all (i...
December 4, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29217451/between-trial-heterogeneity-in-meta-analyses-may-be-partially-explained-by-reported-design-characteristics
#8
K M Rhodes, R M Turner, J Savović, H E Jones, D Mawdsley, J P T Higgins
OBJECTIVE: We investigated the associations between risk of bias judgments from Cochrane reviews for sequence generation, allocation concealment and blinding and between-trial heterogeneity. STUDY DESIGN AND SETTING: Bayesian hierarchical models were fitted to binary data from 117 meta-analyses, to estimate the ratio λ by which heterogeneity changes for trials at high/unclear risk of bias, compared to trials at low risk of bias. We estimated the proportion of between-trial heterogeneity in each meta-analysis that could be explained by the bias associated with specific design characteristics...
December 4, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29208415/guideline-on-terminology-and-definitions-of-updating-clinical-guidelines-the-updating-glossary
#9
L Martínez García, H Pardo-Hernández, A J Sanabria, P Alonso-Coello, K Penman, E McFarlane
OBJECTIVE: The Guidelines International Network (G-I-N) Updating Guidelines Working Group launched an initiative to develop a glossary (the Updating Glossary) with domains, terms, definitions, and synonyms related to updating of clinical guidelines (CGs). STUDY DESIGN AND SETTING: The Steering Committee developed an initial list of domains, terms, definitions, and synonyms through brainstorming and discussion. The Panel Members participated in three rounds of feedback to discuss, refine, and clarify the proposed terms, definitions, and synonyms...
December 2, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29203419/flaws-in-the-application-and-interpretation-of-statistical-analyses-in-systematic-reviews-of-therapeutic-interventions-were-common-a-cross-sectional-analysis
#10
Matthew J Page, Douglas G Altman, Joanne E McKenzie, Larissa Shamseer, Nadera Ahmadzai, Dianna Wolfe, Fatemeh Yazdi, Ferrán Catalá-López, Andrea C Tricco, David Moher
OBJECTIVES: To investigate the application and interpretation of statistical analyses in a cross-section of systematic reviews (SRs) of therapeutic interventions, without restriction by journal, clinical condition, or specialty. STUDY DESIGN AND SETTING: We evaluated a random sample of SRs assembled previously, which were indexed in MEDLINE® during February 2014, focused on a treatment or prevention question, and reported at least one meta-analysis. The reported statistical methods used in each SR were extracted from articles and online appendices by one author, with a 20% random sample extracted in duplicate...
December 1, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29203418/electronic-medical-records-can-be-used-to-emulate-target-trials-of-sustained-treatment-strategies
#11
Goodarz Danaei, Luis Alberto García Rodríguez, Oscar Fernández Cantero, Roger W Logan, Miguel A Hernán
OBJECTIVE: To emulate three target trials: single treatment versus no treatment, joint treatment versus no treatment, and head-to-head comparison of two treatments. We explain how to estimate the observational analogs of intention-to-treat and per-protocol effects, using hazard ratios and survival curves. For per-protocol effects, we describe two methods for adherence adjustment via inverse-probability weighting. STUDY DESIGN AND SETTING: Prospective observational study using electronic medical records of individuals aged 55-84 with coronary heart disease from >500 practices in the United Kingdom between 2000-2010...
December 1, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29197646/one-stage-and-two-stage-meta-analysis-of-individual-participant-data-led-to-consistent-summarized-evidence-lessons-learned-from-combining-multiple-databases
#12
Lorenza Scotti, Federico Rea, Giovanni Corrao
OBJECTIVE: Combining multiple healthcare databases allows comparing the effects of a wide variety of healthcare services. There is a growing interest in methods for combining the results from multiple databases. We attempted to learn lessons about the performance of one-stage and two-stage approaches from the re-analysis of data drawn from two studies of pharmacoepidemiology based on multiple databases. STUDY DESIGN AND SETTING: Two nested case-control studies were carried out for estimating the tricyclic antidepressants-arrhythmia and etoricoxib-heart failure associations, respectively from the Italian I-GrADE and the European SOS programs...
November 29, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29196202/node-making-process-in-network-meta-analysis-of-non-pharmacological-treatment-are-poorly-reported
#13
Arthur James, Amélie Yavchitz, Philippe Ravaud, Isabelle Boutron
OBJECTIVE: Identify methods to support the node-making process in network meta-analyses (NMAs) of non-pharmacological treatments. DESIGN: We proceeded in two stages. First, we conducted a literature review of guidelines and methodological articles about NMAs to identify methods proposed to lump interventions into nodes. Second, we conducted a systematic review of NMAs of non-pharmacological treatments to extract methods used by authors to support their node-making process...
November 28, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29191447/comparative-evidence-on-harms-in-pediatric-rcts-from-less-developed-versus-more-developed-countries-is-limited
#14
REVIEW
Dario Tedesco, Mufiza Farid-Kapadia, Martin Offringa, Zulfiqar A Bhutta, Yvonne Maldonado, John P A Ioannidis, Despina G Contopoulos-Ioannidis
OBJECTIVE: Evaluate comparative harm-rates from medical interventions in pediatric randomized-trials (RCTs) from more-developed (MDCs) and less-developed countries (LDCs). STUDY DESIGN: Meta-epidemiologic empirical evaluation of Cochrane Database of Systematic Reviews (June 2014) meta-analyses reporting clinically-important harm-outcomes (severe adverse events [AEs], discontinuations due to AEs, any AE and mortality) that included at least 1 pediatric-RCT from MDCs and at least 1 from LDCs...
November 27, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29191446/the-efficiency-of-database-searches-for-creating-systematic-reviews-was-improved-by-search-filters
#15
Dalton Budhram, Tamara Navarro-Ruan, R Brian Haynes
OBJECTIVE: To compare Clinical Queries (CQs) for randomized trials of therapy 'methods' and 'NOT' limits search filters with Cochrane methods filters (CSs). STUDY DESIGN AND SETTING: Analytic survey of Cochrane reviews as the reference standard for retrieving studies included in the reviews ('included studies'). The sensitivity and precision of Cochrane content terms + Cochrane methods terms were compared in MEDLINE and Embase with Cochrane content terms + Clinical Queries maximally sensitive filter for therapy studies, without and with additional 'NOT' limits (CQ-S; CQ-S + limits) and a balanced filter without and with additional NOT limits (CQ-B; CQ-B + limits)...
November 27, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29191445/training-health-professionals-to-recruit-into-challenging-randomized-controlled-trials-improved-confidence-the-development-of-the-quintet-rct-recruitment-training-intervention
#16
Nicola Mills, Daisy Gaunt, Jane M Blazeby, Daisy Elliott, Samantha Husbands, Peter Holding, Leila Rooshenas, Marcus Jepson, Bridget Young, Peter Bower, Catrin Tudur Smith, Carrol Gamble, Jenny L Donovan
OBJECTIVE: To describe and evaluate a training intervention for recruiting patients to randomized controlled trials (RCTs), particularly for those anticipated to be difficult for recruitment. STUDY DESIGN AND SETTING: One of three training workshops were offered to surgeons and one to research nurses. Self-confidence in recruitment was measured through questionnaires before and up to three months after training; perceived impact of training on practice was assessed after...
November 27, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29183689/participation-and-retention-can-be-high-in-randomized-controlled-trials-targeting-underserved-populations-a-systematic-review-and-meta-analysis
#17
Rohit P Ojha, Bradford E Jackson, Yan Lu, Mandy Burton, Somer E Blair, Brooke MacDonald, Tzu-Chun Chu, Kari Teigen, Melissa Acosta
OBJECTIVE: We aimed to systematically review published literature to assess study-level sources of heterogeneity in participation and retention for randomized controlled trials (RCTs) conducted exclusively at safety-net institutions, which are primary sources of care for underserved populations. STUDY DESIGN AND SETTING: We searched PubMed/Medline and the Cochrane Central Register of Controlled Trials to identify phase III RCTs of any topic conducted exclusively at safety-net institutions in the United States through October 15, 2016...
November 25, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29180056/review-of-a-licensed-dengue-vaccine-inappropriate-subgroup-analyses-and-selective-reporting-may-cause-harm-in-mass-vaccination-programs
#18
Antonio L Dans, Leonila F Dans, Mary Ann D Lansang, Maria Asuncion A Silvestre, Gordon H Guyatt
Severe life-threatening dengue fever usually occurs when a child is infected by dengue virus a 2nd time. This is caused by a phenomenon called antibody dependent enhancement or ADE. Since dengue vaccines can mimic a first infection in seronegative children (those with no previous infection), a natural infection later in life could lead to severe disease. The possibility that dengue vaccines can cause severe dengue through ADE has led to serious concern regarding the safety of mass vaccination programs. A published meta-analysis addressed this safety issue for a new vaccine against dengue fever - Dengvaxia ™...
November 24, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29174118/poor-performance-of-clinical-prediction-models-the-harm-of-commonly-applied-methods
#19
Ewout W Steyerberg, Hajime Uno, John P A Ioannidis, Ben van Calster, Chinedu Ukaegbu, Tara Dhingra, Sapna Syngal, Fay Kastrinos
OBJECTIVE: To evaluate limitations of common statistical modeling approaches in deriving clinical prediction models and explore alternative strategies. STUDY DESIGN AND SETTING: A previously published model predicted the likelihood of having a mutation at the time of diagnosis of colorectal cancer. This model was based on a cohort where 38 mutations were found among 870 participants, with validation in an independent cohort with 35 mutations. The modeling strategy included stepwise selection of predictors from a pool of 37 candidate predictors and dichotomization of continuous predictors...
November 23, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29175415/multiple-overlapping-systematic-reviews-facilitate-the-origin-of-disputes-the-case-of-thrombolytic-therapy-for-pulmonary-embolism
#20
Nicoletta Riva, Livia Puljak, Lorenzo Moja, Walter Ageno, Holger Schünemann, Nicola Magrini, Alessandro Squizzato
OBJECTIVE: To explore disagreements in multiple systematic reviews (SRs) assessing the benefit-to-harm ratio of thrombolytic therapy in patients with intermediate-risk pulmonary embolism (PE). STUDY DESIGN AND SETTING: MEDLINE, EMBASE, CDSR and DARE were searched up to April 14, 2016. We included SRs and guidelines that evaluated thrombolytic therapy, compared to anticoagulation alone, in intermediate-risk PE. We calculated pooled risk ratio (RR) and absolute risk difference (RD), with interquartile range (IQR), for all-cause mortality, recurrent PE and major bleeding...
November 21, 2017: Journal of Clinical Epidemiology
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