12 research outputs found
The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE).
In pharmacoepidemiology, routinely
collected data from electronic health
records (including primary care
databases, registries, and
administrative healthcare claims) are a
resource for research evaluating the
real world effectiveness and safety of
medicines. Currently available
guidelines for the reporting of research
using non-randomised, routinely
collected data—specifically the
REporting of studies Conducted using
Observational Routinely collected
health Data (RECORD) and the
Strengthening the Reporting of
OBservational studies in Epidemiology
(STROBE) statements—do not
capture the complexity of
pharmacoepidemiological research.
We have therefore extended the
RECORD statement to include
reporting guidelines specific to
pharmacoepidemiological research
(RECORD-PE). This article includes the
RECORD-PE checklist (also available on
www.record-statement.org) and
explains each checklist item with
examples of good reporting. We
anticipate that increasing use of the
RECORD-PE guidelines by researchers
and endorsement and adherence by
journal editors will improve the
standards of reporting of
pharmacoepidemiological research
undertaken using routinely collected
data. This improved transparency will
benefit the research community,
patient care, and ultimately improve
public health
Canadian Association of Gastroenterology Clinical Practice Guideline for the Medical Management of Pediatric Luminal Crohn's Disease
Background & Aims: We aim to provide guidance for medical treatment of luminal Crohn's disease in children. Methods: We performed a systematic search of publication databases to identify studies of medical management of pediatric Crohn's disease. Quality of evidence and strength of recommendations were rated according to the GRADE (Grading of Recommendation Assessment, Development, and Evaluation) approach. We developed statements through an iterative online platform and then finalized and voted on them. Results: The consensus includes 25 statements focused on medical treatment options. Consensus was not reached, and no recommendations were made, for 14 additional statements, largely due to lack of evidence. The group suggested corticosteroid therapies (including budesonide for mild to moderate disease). The group suggested exclusive enteral nutrition for induction therapy and biologic tumor necrosis factor antagonists for induction and maintenance therapy at diagnosis or at early stages of severe disease, and for patients failed by steroid and immunosuppressant induction therapies. The group recommended against the use of oral 5-aminosalicylate for induction or maintenance therapy in patients with moderate disease, and recommended against thiopurines for induction therapy, corticosteroids for maintenance therapy, and cannabis in any role. The group was unable to clearly define the role of concomitant immunosuppressants during initiation therapy with a biologic agent, although thiopurine combinations are not recommended for male patients. No consensus was reached on the role of aminosalicylates in treatment of patients with mild disease, antibiotics or vedolizumab for induction or maintenance therapy, or methotrexate for induction therapy. Patients in clinical remission who are receiving immunomodulators should be assessed for mucosal healing within 1 year of treatment initiation. Conclusions: Evidence-based medical treatment of Crohn's disease in children is recommended, with thorough ongoing assessments to define treatment success
Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE)
Objectives
Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated Standards of Reporting Trials (CONSORT) statement extension for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) has been developed with the goal of improving reporting quality. This article describes the processes and methods used to develop the extension and decisions made to arrive at the final checklist.
Methods
The development process involved five stages: (1) identification of the need for a reporting guideline and project launch; (2) conduct of a scoping review to identify possible modifications to CONSORT 2010 checklist items and possible new extension items; (3) a three-round modified Delphi study involving key stakeholders to gather feedback on the checklist; (4) a consensus meeting to finalise items to be included in the extension, followed by stakeholder piloting of the checklist; and (5) publication, dissemination and implementation of the final checklist.
Results
27 items were initially developed and rated in Delphi round 1, 13 items were rated in round 2 and 11 items were rated in round 3. Response rates for the Delphi study were 92 of 125 (74%) invited participants in round 1, 77 of 92 (84%) round 1 completers in round 2 and 62 of 77 (81%) round 2 completers in round 3. Twenty-seven members of the project team representing a variety of stakeholder groups attended the in-person consensus meeting. The final checklist includes five new items and eight modified items. The extension Explanation & Elaboration document further clarifies aspects that are important to report.
Conclusion
Uptake of CONSORT-ROUTINE and accompanying Explanation & Elaboration document will improve conduct of trials, as well as the transparency and completeness of reporting of trials conducted using cohorts and routinely collected data
CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration
Randomised controlled trials are increasingly conducted as embedded, nested, or using cohorts or routinely collected data, including registries, electronic health records, and administrative databases, to assess if participants are eligible for the trial and to facilitate recruitment, to deliver an embedded intervention, to collect trial outcome data, or a combination of these purposes. This report presents the Consolidated Standards of Reporting Trials (CONSORT) extension for randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE). The extension was developed to look at the unique characteristics of trials conducted with these types of data with the goal of improving reporting quality in the long term by setting standards early in the process of uptake of these trial designs. The extension was developed with a sequential approach, including a Delphi survey, a consensus meeting, and piloting of the checklist. The checklist was informed by the CONSORT 2010 statement and two reporting guidelines for observational studies, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement and the REporting of studies Conducted using Observational Routinely collected Data (RECORD) statement. The extension includes eight items modified from the CONSORT 2010 statement and five new items. Reporting items with explanations and examples are provided, including key aspects of trials conducted using cohorts or routinely collected data that require specific reporting considerations
La déclaration RECORD-PE (Reporting of Studies Conducted Using Observational Routinely Collected Health Data Statement for Pharmacoepdemiology) : directives pour la communication des études realisées à partir de données de santé observationelles collectées en routine en pharmacoépidémiologie []
En pharmacoépidémiologie, les données collectées en routine dans les
dossiers de santé électroniques (y compris les bases de données de soins
primaires, les registres et les demandes de remboursement des soins de
santé medico-administratifs) constituent une ressource pour la recherche
sur l'efficacité et l'innocuité des médicaments. Les directives
actuellement disponibles pour le rapport de la recherche à l'aide de
données collectées en routine et non randomisées - en particulier les
directives RECORD (REporting of studies Conducted using Observational
Routinely collected health Data) et STROBE (Strengthening the Reporting
of Observational Studies in Epidemiology) - ne rendent pas compte de la
complexité de la recherche pharmacoépidémiologique. Nous avons donc
étendu les directives RECORD pour inclure les directives spécifiques à la
recherche pharmacoépidémiologique (RECORD-PE). Cet article inclut la
liste de contrôle RECORD-PE (également disponible sur www.recordstatement.org) et explique chaque élément de la liste de contrôle avec
des exemples de bons compte-rendus. Nous prévoyons que l'utilisation
croissante des directives RECORD-PE par les chercheurs, ainsi que
l'approbation des éditeurs de revues, amélioreront les normes de
compte-rendu des recherches pharmacoépidémiologiques entreprises à
l'aide de données collectées en routine. Cette transparence améliorée
profitera à la communauté des chercheurs, aux soins des patients et, en
définitive, à l’amélioration de la santé publique
Meeting abstracts from the 5th International Clinical Trials Methodology Conference (ICTMC 2019)
Introduction: Recruitment of participants to, and their retention in, Randomised Controlled Trials (RCTs) is a key determinant of research efficiency, but is challenging. Digital tools and media are increasingly used to reduce costs, waste and delays in the conduct and delivery of research. The aim of this UK Clinical Trials Unit (CTU) survey was to identify which digital recruitment and retention tools are being used to support RCTs, their benefits and success characteristics.Methods: A survey was sent to all UK Clinical Research Collaboration(UKCRC)-registered CTUs with a webinar to help increase completion. A logic model and definitions of a “digital tool” were developed by iterative refinement by project team members, the Advisory Board(NIHR Research Design service, NHS Trust, NIHR Clinical Research Net-works and patient input) and CTUs.Results: A total of 24/52 (46%) CTUs responded, 6 (25%) of which stated no prior use. Database screening tools (e.g. CPRD, EMIS) were the tool most widely used (10/22 45%) for recruitment and were con-side red very effective (7/10 70%). The most mentioned success criteria were saving GP time and reaching more patients. Social media was second (6/22 27%), but estimated effectiveness varied consider-ably, with only 17% stating very effective. Fewer retention tools were used, with SMS / email reminders reported most (10/15 67%), but certainty about effectiveness varied. A table of potential digital tools to support recruitment and retention tasks, with examples and a logic model showing relationships between the resources, activities, outputs and outcomes for digital tools were developed. Discussion: Database screening tools are the most commonly used digital tool for recruitment, with clear success criteria and certainty about effectiveness. Our detailed definition of what constitutes a digital tool, with examples, will inform the NIHR research community about choices and help them identify potential tools to support recruitment and retention.<br/