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1.
J Clin Epidemiol ; 132: A5-A6, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-33775388
3.
Int J Technol Assess Health Care ; 37: e17, 2021 Jan 25.
Artículo en Inglés | MEDLINE | ID: mdl-33491618

RESUMEN

OBJECTIVES: Health technology assessment (HTA) can impact health inequities by informing healthcare priority-setting decisions. This paper presents a novel checklist to guide HTA practitioners looking to include equity considerations in their work: the equity checklist for HTA (ECHTA). The list is pragmatically organized according to the generic HTA phases and can be consulted at each step. METHODS: A first set of items was based on the framework for equity in HTA developed by Culyer and Bombard. After rewording and reorganizing according to five HTA phases, they were complemented by elements emerging from a literature search. Consultations with method experts, decision makers, and stakeholders further refined the items. Further feedback was sought during a presentation of the tool at an international HTA conference. Lastly, the checklist was piloted through all five stages of an HTA. RESULTS: ECHTA proposes elements to be considered at each one of the five HTA phases: Scoping, Evaluation, Recommendations and Conclusions, Knowledge Translation and Implementation, and Reassessment. More than a simple checklist, the tool provides details and examples that guide the evaluators through an analysis in each phase. A pilot test is also presented, which demonstrates the ECHTA's usability and added value. CONCLUSIONS: ECHTA provides guidance for HTA evaluators wishing to ensure that their conclusions do not contribute to inequalities in health. Several points to build upon the current checklist will be addressed by a working group of experts, and further feedback is welcome from evaluators who have used the tool.

4.
Artículo en Inglés | MEDLINE | ID: mdl-33483129

RESUMEN

BACKGROUND: Underreporting of harms in randomized controlled trials (RCTs) may lead to incomplete or erroneous assessments of the perceived benefit-to-harm profile of an intervention. To compare benefit with harm in clinical practice and future clinical studies, adverse event (AE) profiles including severity need to be understood. Even though patients report harm symptoms earlier and more frequently than clinicians, rheumatology RCTs currently do not provide a reporting framework from the patient's perspective regarding harms. Our objective for this meta-research project was to identify AEs in order to determine harm clusters and whether these could be self-reported by patients. Our other objective was to examine reported severity grading of the reported harms. METHODS: We considered primary publications of RCTs eligible if they were published between 2008 and 2018 evaluating pharmacological interventions in patients with a rheumatic or musculoskeletal condition and if they were included in Cochrane reviews. We extracted data on harms such as reported AE terms together with severity (if described), and categorized AE- and severity-terms into overall groups. We deemed all AEs with felt components appropriate for patient self-reporting. RESULTS: The literature search identified 187 possible Cochrane reviews, of which 94 were eligible for evaluation, comprising 1,297 articles on individual RCTs. Of these RCTs, 93 pharmacological trials met our inclusion criteria (including 31,023 patients; representing 20,844 accumulated patient years), which reported a total of 21,498 AEs, corresponding to 693 unique reported terms for AEs. We further sub-categorized these terms into 280 harm clusters (i.e., themes). AEs appropriate for patient self-reporting accounted for 58% of the AEs reported. Among the reported AEs, we identified medical terms for all of the 117 harm clusters appropriate for patient reporting and lay language terms for 86%. We intended to include severity grades of the reported AEs, but there was no evidence for systematic reporting of clinician- or patient-reported severity in the primary articles of the 93 trials. However, we identified 33 terms suggesting severity, but severity grading was discernible in only 9%, precluding a breakdown by severity in this systematic review. CONCLUSIONS: Our results support the need for a standardized framework for patients' reporting of harms in rheumatology trials. Reporting of AEs with severity should be included in future reporting of harms, both from the patients' and investigators' perspectives. REGISTRATION: PROSPERO: CRD42018108393.

5.
J Clin Epidemiol ; 129: A6-A7, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33422268
6.
J Clin Epidemiol ; 129: A8-A9, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33422269
7.
Artículo en Inglés | PAHO-IRIS | ID: phr-53189

RESUMEN

To the Editor, During the past quarter of a century and following the global explosion in access to scientific literature, systematic reviews have become an excellent way to inform decisions with summaries of the effects of interventions, and to learn about their impact under different conditions or among populations. Systematic reviews play a key role in ensuring that policy decisions are informed by research. Local and national governments as well as international health organizations now regularly commission and request that systematic reviews inform policy decisions. [...]


Asunto(s)
Revisión Sistemática , Infecciones por Coronavirus , Coronavirus , Infecciones por Coronavirus , Hidroxicloroquina , Virus del SRAS , Betacoronavirus
8.
J Clin Epidemiol ; 130: A6-A7, 2021 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33483005
9.
J Clin Epidemiol ; 134: 52-64, 2021 Jan 21.
Artículo en Inglés | MEDLINE | ID: mdl-33485928

RESUMEN

OBJECTIVE: This paper presents a unified framework for assessment of the methodological quality of analytic study designs. STUDY DESIGN AND SETTING: A systematic review of 393 methodological quality assessment tools that updated a previous assessment with 100 tools. Tool items were extracted, examined and reworded. Bias domains and finally methodological standards to be fulfilled were defined. RESULTS: There were 36 unique methodological safeguards that were categorized into seven methodological standards to be fulfilled in the MASTER scale. These methodological standards reflect initial and ongoing equivalence in particular areas, including equal recruitment, equal retention, equal ascertainment, equal implementation, equal prognosis, sufficient analysis, and temporal precedence. CONCLUSION: This approach unifies existing methods for methodological quality assessment and will be useful for (1) clinical researchers when a bias assessment of clinical research studies is required across analytical designs, (2) promoting a unified framework for bias assessment.

10.
J Clin Epidemiol ; 2020 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-33276054

RESUMEN

OBJECTIVE: To present a structured approach for assessing stakeholder perceptions and implementing the approach in guideline development. STUDY DESIGN AND SETTING: This work was carried out by the GRADE Equity and Stakeholder Engagement Project Groups through brainstorming and iterative frameworks, stakeholder engagement, pilot testing, refinement of ideas, using input from workshops and discussions at GRADE Working Group meetings to produce this document, which constitutes a GRADE conceptual paper on implementation. RESULTS: We introduce the FACE implementation criteria, Feasibility, Acceptability, Cost and Equity, priority and 'intent to implement' criterion. We outline the implementation importance of networks and approaches to patient and other stakeholder engagement. Implementation is often highly contextual and can benefit from stakeholder engagement and other assessments. Our FACE approach provides stakeholder questions and language to inform guideline implementation and tools. CONCLUSION: The FACE criteria propose a series of knowledge translation questions to guide the assessment of implementation for evidence-based guidelines. It is desirable for guideline developers to use a conceptual approach, like FACE, to tailor implementation and inform end of guideline dissemination and knowledge translation activities.

11.
BMJ Open ; 10(12): e040122, 2020 Dec 07.
Artículo en Inglés | MEDLINE | ID: mdl-33293309

RESUMEN

INTRODUCTION: Venous thromboembolism (VTE) is a common, potentially fatal yet treatable disease. Several advances in treatment of VTE have been made over the past decades, but definition and reporting of outcomes across those studies are inconsistent. Development of an international core outcome set for clinical studies of interventions for VTE addresses this lack of standardisation. The first step in the development of a core outcome set is to conduct a scoping review which aims to generate an inclusive list of unique outcomes that have been reported in previous studies. METHODS AND ANALYSIS: MEDLINE, Embase and the Cochrane Central Register of Controlled Trials will be searched with no language restriction for prospective studies reporting on interventions for treatment of VTE in patients who are adult and non-pregnant. Records will be sorted in reverse chronological order. Study screening and data extraction will be independently performed by two authors in blocks based on date of publication, starting with 2015 to 2020 and subsequent 1-year periods, until no new outcome measures are identified from the set of included studies. After homogenising spelling and combining outcomes with the same meaning, a list of unique outcomes will be determined. Those outcomes will be grouped into outcome domains. Qualitative analysis and descriptive statistics will be used to report results. ETHICS AND DISSEMINATION: Ethical approval is not required for this study. The results of this scoping review will be presented at scientific conferences, published in a peer-reviewed journal, and they will provide candidate outcome domains to be considered in subsequent steps in the development of a core outcome set for clinical studies of interventions for VTE. PROTOCOL REGISTRATION DETAILS: http://hdl.handle.net/10393/40459.

12.
BMJ Open ; 10(12): e040478, 2020 12 17.
Artículo en Inglés | MEDLINE | ID: mdl-33334836

RESUMEN

INTRODUCTION: Methodological studies (ie, studies that evaluate the design, conduct, analysis or reporting of other studies in health research) address various facets of health research including, for instance, data collection techniques, differences in approaches to analyses, reporting quality, adherence to guidelines or publication bias. As a result, methodological studies can help to identify knowledge gaps in the methodology of health research and strategies for improvement in research practices. Differences in methodological study names and a lack of reporting guidance contribute to lack of comparability across studies and difficulties in identifying relevant previous methodological studies. This paper outlines the methods we will use to develop an evidence-based tool-the MethodologIcal STudy reportIng Checklist-to harmonise naming conventions and improve the reporting of methodological studies. METHODS AND ANALYSIS: We will search for methodological studies in the Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Embase, MEDLINE, Web of Science, check reference lists and contact experts in the field. We will extract and summarise data on the study names, design and reporting features of the included methodological studies. Consensus on study terms and recommended reporting items will be achieved via video conference meetings with a panel of experts including researchers who have published methodological studies. ETHICS AND DISSEMINATION: The consensus study has been exempt from ethics review by the Hamilton Integrated Research Ethics Board. The results of the review and the reporting guideline will be disseminated in stakeholder meetings, conferences, peer-reviewed publications, in requests to journal editors (to endorse or make the guideline a requirement for authors), and on the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network and reporting guideline websites. REGISTRATION: We have registered the development of the reporting guideline with the EQUATOR Network and publicly posted this project on the Open Science Framework (www.osf.io/9hgbq).


Asunto(s)
Lista de Verificación , Proyectos de Investigación , Consenso , Humanos , Publicaciones
14.
J Clin Epidemiol ; 128: A6-A8, 2020 12.
Artículo en Inglés | MEDLINE | ID: mdl-33228925
17.
Artículo en Inglés | MEDLINE | ID: mdl-33202101

RESUMEN

OBJECTIVE: There is an unmet need for reliable, validated, and widely-accepted outcome measures for randomized clinical trials in Behçet syndrome (BS). The Outcome Measures in Rheumatology Clinical Trials (OMERACT) BS Working Group, a large, multi-disciplinary group of experts in BS and patients with BS, worked to develop a Core Set of data-driven outcome measures for use in all clinical trials of BS. METHODS: The Core Domain Set was developed through a comprehensive, iterative, multi-stage project which included a systematic review, a focus group meeting and qualitative patient interviews, a survey among experts in BS, a Delphi exercise involving both patients and physician-experts in BS, and utilization of the data, insight, and feedback generated by these processes to develop a final Core Domain Set. RESULTS: All steps were completed and domains were delineated across the organ systems involved in this disease. Since trials in BS often focus on specific manifestations and not the disease in its entirety, the final proposed Core Set includes 5 domains mandatory for study in all trials in BS (disease activity, new organ involvement, quality of life, adverse events, and death) with additional sub-domains mandatory for study of specific organ-systems. The final Core Set was endorsed at the 2018 OMERACT meeting. CONCLUSION: The Core Set of Domains in BS provides the foundation through which the international research community, including clinical investigators, patients, biopharmaceutical industry, and government regulatory bodies can harmonize the study of this complex disease, compare findings across studies, and advance development of effective therapies.

18.
Br J Sports Med ; 2020 Nov 03.
Artículo en Inglés | MEDLINE | ID: mdl-33144350

RESUMEN

OBJECTIVE: When appraising the quality of randomised clinical trial (RCTs) on the merits of exercise therapy, we typically limit our assessment to the quality of the methods. However, heterogeneity across studies can also be caused by differences in the quality of the exercise interventions (ie, 'the potential effectiveness of a specific intervention given the potential target group of patients')-a challenging concept to assess. We propose an internationally developed, consensus-based tool that aims to assess the quality of exercise therapy programmes studied in RCTs: the international Consensus on Therapeutic Exercise aNd Training (i-CONTENT) tool. METHODS: Forty-nine experts (from 12 different countries) in the field of physical and exercise therapy participated in a four-stage Delphi approach to develop the i-CONTENT tool: (1) item generation (Delphi round 1), (2) item selection (Delphi rounds 2 and 3), (3) item specification (focus group discussion) and (4) tool development and refinement (working group discussion and piloting). RESULTS: Out of the 61 items generated in the first Delphi round, consensus was reached on 17 items, resulting in seven final items that form the i-CONTENT tool: (1) patient selection; (2) qualified supervisor; (3) type and timing of outcome assessment; (4) dosage parameters (frequency, intensity, time); (5) type of exercise; (6) safety of the exercise programme and (7) adherence to the exercise programme. CONCLUSION: The i-CONTENT-tool is a step towards transparent assessment of the quality of exercise therapy programmes studied in RCTs, and ultimately, towards the development of future, higher quality, exercise interventions.

19.
Patient ; 13(6): 719-728, 2020 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-33033937

RESUMEN

BACKGROUND: Youths with juvenile idiopathic arthritis (JIA) often experience pain, which reduces their quality of life. A diversity of pain management options exists for these patients, but few discussions happen in clinical settings. Our team is developing a web-based patient decision aid (PDA) to help youths with JIA, parents, and their health care providers (HCPs) make informed and preference-based decisions about pain management options. OBJECTIVE: The objective of this study was to develop a paper-based prototype of the web-based PDA and to assess its acceptability. METHODS: We developed a paper-based prototype of the PDA, called the JIA Option Map, using an iterative process following the International Patient Decision Aid Standards and based on the Ottawa Decision Support Framework. We held three consensus meetings and a follow-up online survey followed by discussions among team members to agree on the format and content of the PDA. We then evaluated acceptability through interviews with 12 youth with JIA (aged 8-18 years), 12 parents, and 11 HCPs. Participants from rheumatology clinics in Canada and the USA reviewed the PDA and assessed its usefulness, content, and format. Interviews were audiotaped, transcribed verbatim, and analyzed using simple descriptive content analysis. RESULTS: The PDA contains an assessment of pain and current treatments, a values-clarification exercise, a list of 33 treatment options with evidence-based information, and a goal-setting exercise. All participants agreed that it would be a useful tool for making decisions about pain management. Participants appreciated the incorporation of scientific evidence and visuals to demonstrate the benefits of treatment options but suggested describing the source of the evidence more thoroughly. Participants suggested adding complementary medicine and nutrition to the available treatment options and removing options that are primarily used to reduce inflammation. Most participants preferred an interactive web-based version of the PDA that would show a few options consistent with their preferences, followed by a discussion with HCPs. CONCLUSION: The PDA was deemed acceptable to all participants, with a few modifications. This feedback was used to improve the PDA by simplifying and clarifying the information and adjusting the number of treatment options presented. Work is underway to develop an interactive web-based version with an algorithm to present options tailored to each user.

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