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Item does not contain fulltext, The use of invasive placebo controls in surgical trials can be challenging. The ASPIRE guidance, published in the Lancet in 2020, provided advice for the design and conduct of surgical trials with an invasive placebo control. Based on a more recent international expert workshop in June 2022, we now provide further insights into this topic. These include the purpose and design of invasive placebo controls, patient information provision and how findings from these trials may be used to inform decision-making.

Contains fulltext : 234331.pdf (Publisher’s version ) (Open Access)

Contains fulltext : 234358.pdf (Publisher’s version ) (Open Access), 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

Contains fulltext : 209458.pdf (publisher's version ) (Open Access), Background: Randomised controlled trials (RCTs) are increasingly being conducted using existing sources of data, such as cohorts, administrative databases, disease registries and electronic health records. RCTs conducted using existing data sources require additional information to be reported. This reporting guideline is an extension of the 2010 version of the Consolidated Standards of Reporting Trials (CONSORT) Statement for RCTs using cohorts and routinely collected health data. Methods: A long-list of potential items for the checklist was identified through two methods: firstly, modifications to the current CONSORT checklist were generated using existing reporting guidelines, including the Reporting of Observational Studies in Epidemiology (STROBE) and REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Secondly, ascoping review of RCTs conducted in the last decade using cohorts and routinely collected health data facilitated the modification and identification of other potential items. Using the long-list, a three-stage Delphi exercise was conducted to assess the importance of each item for inclusion in the final extension checklist, which was finalised at a face-to-face meeting of experts. Results: A long-list of 27 items was created and 125 experts registered for the three-round Delphi exercise (92, 77 and 62 experts participated in each round respectively). Consensus was reached on 21 out of 27 items. The results of the Delphi exercise informed a face-to-face consensus meeting in May 2019; core items to be included in the extension checklist were finalised at this meeting. Corresponding explanations of extensions and new items with examples of good reporting were developed subsequently. Conclusion: The guideline checklist can facilitate transparent reporting of RCTs using cohorts and routinely collected health data, to assist evaluations of rigour and reproducibility, enhance understanding of the methodolog

Contains fulltext : 194062.pdf (publisher's version ) (Open Access), Introduction: Randomised controlled trials (RCTs) conducted using cohorts and routinely collected health data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. The development of an extension of the CONsolidated Standards of Reporting Trials (CONSORT) statement for RCTs using cohorts and routinely collected health data is being undertaken with the goal of improving reporting quality by setting standards early in the process of uptake of these designs. To develop this extension to the CONSORT statement, a scoping review will be conducted to identify potential modifications or clarifications of existing reporting guideline items, as well as additional items needed for reporting RCTs using cohorts and routinely collected health data. Methods and analysis: In separate searches, we will seek publications on methods or reporting or that describe protocols or results from RCTs using cohorts, registries, electronic health records and administrative databases. Data sources will include Medline and the Cochrane Methodology Register. For each of the four main types of RCTs using cohorts and routinely collected health data, separately, two investigators will independently review included publications to extract potential checklist items. A potential item will either modify an existing CONSORT 2010, Strengthening the Reporting of Observational Studies in Epidemiology or REporting of studies Conducted using Observational Routinely collected health Data item or will be proposed as a new item. Additionally, we will identify examples of good reporting in RCTs using cohorts and routinely collected health data. Ethics and dissemination: The proposed scoping review will help guide the development of the CONSORT extension statement for RCTs conducted using cohorts and routinely collected health data.

Contains fulltext : 197751.pdf (publisher's version ) (Open Access), Background: Randomized controlled trials (RCTs) are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, and many have limited real-world generalizability. Designs for RCTs conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, have been proposed to address these challenges and are being rapidly adopted. These designs, however, are relatively recent innovations, and published RCT reports often do not describe important aspects of their methodology in a standardized way. Our objective is to extend the Consolidated Standards of Reporting Trials (CONSORT) statement with a consensus-driven reporting guideline for RCTs using cohorts and routinely collected health data. Methods: The development of this CONSORT extension will consist of five phases. Phase 1 (completed) consisted of the project launch, including fundraising, the establishment of a research team, and development of a conceptual framework. In phase 2, a systematic review will be performed to identify publications (1) that describe methods or reporting considerations for RCTs conducted using cohorts and routinely collected health data or (2) that are protocols or report results from such RCTs. An initial "long list" of possible modifications to CONSORT checklist items and possible new items for the reporting guideline will be generated based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Additional possible modifications and new items will be identified based on the results of the systematic review. Phase 3 will consist of a three-round Delphi exercise with methods and content experts to evaluate the "long list" and generate a "short list" of key items. In phase 4, these items will serve as the basis fo

Background: Computer-tailored health education, a promising health education technique, is increasingly being delivered interactively, for example, over the Internet. It has been suggested that there may be differences in use and appreciation between print and interactive delivery of computer-tailored interventions, which may influence information processing. This may especially be the case for women, older people, and people of lower socioeconomic status. Knowledge about differences in use and appreciation could help in choosing the appropriate delivery mode for a particular target audience. Objective: The study investigates a content-identical, computer-tailored intervention addressing saturated fat intake delivered via print or CD-ROM. We analyzed consumer use and appreciation of the feedback information and explored whether possible differences exist among gender, age, and education subgroups. Methods: Healthy Dutch adults (18-65 years), none of whom were under treatment for hypercholesterolemia, were randomly allocated to receive a computer-tailored program on CD-ROM (n = 151) or in print (n = 141). At baseline, data were collected on gender, age, and education level. One month post-intervention, data were collected on the use (feedback information read, saved, discussed) and appreciation (trustworthiness, perceived individualization, perceived personal relevance, and user-friendliness) of the feedback. Statistical analyses on the use and appreciation items were performed using chi-square tests and independent-samples t tests. Results: After exclusion of individuals with missing values, a total of 257 and 240 respondents were included in the analyses of the use outcomes of feedback read and saved, respectively. The results indicate that among the total population, the print feedback was read more often than the CD-ROM feedback (95% vs 81%; P = .001) and saved more often than the CD-ROM feedback (97% vs 77%; P < .001). Similar results were found among the gender

A feed-forward neural net technique is applied to trigger on decays in the high background environment of collisions at Ecm = 1.8 TeV. For the 1992 data run, we will install electronics into the CDF detector trigger using calorimeter signals as input to a neural net IC chip. We describe our algorithm and network optimization (training) issues, including those unique to p physics and to an electronic implementation. We assess the advantages and problems of using trained neural nets. In addition to the trained mode of operation, the architecture of the analog chip also allows employing it as a massively parallel arithmetic processor for conventional trigger applications. The device may be reprogrammed to accommodate changes in trigger requirements and to provide considerable flexibility in trigger design.

Computer-tailored nutrition education is an innovative and promising tool to motivate people to make healthy dietary changes. It provides respondents with individualized feedback about their dietary behaviors, motivations, attitudes, norms, and skills and mimics the process of "person-to-person" dietary counseling. The available evidence indicates that computer-tailored nutrition education is more effective in motivating people to make dietary changes than general nutrition information, especially for reduction of dietary fat. The effectiveness of computer tailoring has been attributed to the fact that individualized feedback commands greater attention, is processed more intensively, contains less redundant information, and is appreciated better than more general intervention materials. Interactive technology (eg, the Internet, the World Wide Web) offers good opportunities for the application of computer-tailored nutrition education, and a first controlled study of Web-based computer tailoring shows promising results. However, using the Web for interactive personalized nutrition education also presents new challenges.

Item does not contain fulltext, The object of this study was to determine which attributes of clinical practice recommendations influence changes in clinical practice following audit and feedback. This was an observational study using multilevel modeling to examine the relationship between attributes of clinical practice recommendations and compliance with the recommendations before and after audit and feedback. Sixteen hospital gynecology units in Scotland participated in a national audit project. Clinical practice recommendations covering selected gynecological topics were developed and data collected to assess baseline (preintervention) compliance. Summaries of performance were fed back to consultant gynecologists in each hospital and follow-up (postintervention) data were collected. Trained audit assistants used standardized forms to abstract data from case notes. Compliance data were available at baseline and follow-up for a total of 42 clinical practice recommendations. Altogether, 4,664 case notes contributed to baseline data and 4,382 to follow-up data. Thirteen attributes describing clinical practice recommendations were developed, based upon previous work, and pretested. A panel of seven consultant gynecologists rated the extent to which each of the 42 recommendations possessed each of the 13 attributes. The main outcome measures were the association of each attribute with compliance and with changes in clinical practice. Recommendations compatible with clinician values and not requiring changes to fixed routines were independently associated with greater compliance at baseline and follow-up. However, recommendations incompatible with clinician values were independently associated with greater change in practice following audit and feedback. Attributes of recommendations may influence the effectiveness of audit and feedback in secondary care. Recommendations seen as incompatible with clinician values are associated with lower compliance but greater behavioral change following audit and f

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