Trish Groves

Bio: Trish Groves is an academic researcher from University of Ottawa. The author has contributed to research in topics: Data sharing & Clinical trial. The author has an hindex of 32, co-authored 125 publications receiving 8470 citations. Previous affiliations of Trish Groves include United Nations Industrial Development Organization & Group Health Cooperative.

SPIRIT 2013 statement: defining standard protocol items for clinical trials.

Abstract: The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

SPIRIT 2013 statement: Defining standard protocol items for clinical trials

Abstract: The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

Spirit 2013 statement: Defining standard protocol items for clinical trials

Abstract: The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.

Abstract: Importance Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance. Objective To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension). Design, Setting, and Participants The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network’s methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols. Results The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n = 21) reduced this to 56 items, which were considered by 138 international stakeholder survey participants and 99 Delphi panelists. The final wording of the SPIRIT-PRO Extension was agreed on at a consensus meeting (n = 29 participants) and reviewed by external group of experts during a consultation period. Eleven extensions and 5 elaborations to the SPIRIT 2013 checklist were recommended for inclusion in clinical trial protocols in which PROs are a primary or key secondary outcome. Extension items focused on PRO-specific issues relating to the trial rationale, objectives, eligibility criteria, concepts used to evaluate the intervention, time points for assessment, PRO instrument selection and measurement properties, data collection plan, translation to other languages, proxy completion, strategies to minimize missing data, and whether PRO data will be monitored during the study to inform clinical care. Conclusions and Relevance The SPIRIT-PRO guidelines provide recommendations for items that should be addressed and included in clinical trial protocols in which PROs are a primary or key secondary outcome. Improved design of clinical trials including PROs could help ensure high-quality data that may inform patient-centered care.

Enhancing the quality and transparency of health research

Abstract: A young woman, just making ends meet and coping with four children, signed up to a breast cancer study where she would have to take two big pills every day for two years and show up for numerous frequent tests. Why would she put herself through that, wondered the researcher who went to obtain her consent. “I’m doing it for my daughter” said the mother, clearly expecting the study to yield usable, meaningful, and accessible evidence that might help prevent breast cancer in young women. Would she have consented so readily if she knew that some studies are never published and that many are reported so poorly that they are barely read and never used? This tale was told by that same researcher, Davina Ghersi, coordinator of the World Health Organization international clinical trials registry,1 at a meeting in London last month. Dr Ghersi was there to help launch the EQUATOR (enhancing the quality and transparency of health research) international network, which seeks to improve the quality of scientific publications by promoting transparent and accurate reporting of health research. Registration, publication, and publicly available reporting of health research are already mandated by several sponsors and funders,2 3 some legislators,4 and many editors,5 particularly for clinical trials. The next big challenge is to decide when and how to disclose the results of a trial at a publicly available research registry, and what should go into a minimum dataset.6 Yet even journals, some of which have been in the business of reporting research for many decades, are still not producing articles that are clear enough to really judge a study’s conduct, quality, and importance—let alone to allow other researchers to reproduce it or build on it. With help from EQUATOR, journals should now be able to do a much better job and give authors the specific guidance they need to write up research properly. Editors already provide instructions to authors, but this advice tends to be either unhelpfully vague and brief or comprehensively long and daunting—for instance, the BMJ’s advice currently extends to well over 20 000 words (http://resources.bmj.com/bmj/authors). The development of more than 80 guidelines for reporting different study types, many of them labelled by acronyms, adds to the confusion. Do authors know where to find these guidelines, and do editors and reviewers know how to use them? Do you know your MOOSE (meta-analysis of observational studies in epidemiology) from your STROBE (strengthening the reporting of observational studies in epidemiology)? The EQUATOR website (www.equator-network.org/) comes to the rescue with a digital library of links to reporting guidelines. These guidelines give point by point advice that enables researchers to say unambiguously what they actually did and didn’t do in their study, how they did it, and what they found, thus allowing honest discussion of the study’s meaning, strengths, and weaknesses. As well as explanatory documents, these guidelines usually incorporate one or two tools—a checklist of items that must be reported clearly (with an empty column for authors to add the page numbers on which each item appears in their manuscript), and a template for a flowchart to show what happened to participants at each stage of the study. The oldest and best known of the current guidelines is the CONSORT (consolidated standards of reporting trials) statement. This has spawned several extensions for different types and aspects of randomised controlled trials, and a plethora of other guidelines have now been developed by consensus groups of experts. The EQUATOR team has identified these guidelines through systematic literature searches, has pulled them together in one place, and has grouped them simply by type of study—including experimental studies, observational studies, systematic reviews, qualitative research, economic evaluations, quality improvement studies, and industry sponsored studies. This is a real boon for the researcher, reviewer, or editor with a desire for clarity but a poor memory for acronyms. EQUATOR is a good resource for readers and learners too. Although these reporting guidelines are not explicitly intended to be critical appraisal tools, anyone running a journal club or sitting an exam that might test research skills should also find them useful. And the digital library is just the start of a comprehensive programme of work on knowledge translation. Over the next five years the EQUATOR network plans to develop much fuller online resources, including training materials for guideline developers, authors, reviewers, and editors, as well as published articles about improving the reporting of research. The network also aims to audit, every year for the next five years, the quality of reporting in health research and the performance of journals in implementing these guidelines. The BMJ is actively supporting the EQUATOR initiative. We ask researchers to prepare each research article in line with the appropriate reporting guideline and to submit each manuscript with the right checklist properly completed and, if necessary, the right flowchart (http://resources.bmj.com/bmj/authors/types-of-article/research) (box). We will not send a research article for external peer review without these, thus giving our policy some teeth and helping reviewers to understand the study’s conduct and quality. How to write a clear research paper Go to the free “one stop shop” at EQUATOR (http://www.equator-network.org/) to find and follow the right guideline for reporting the type of study you have done Next, follow the more general guidance at the International Committee of Medical Journal Editors (http://www.icmje.org/#author ) on manuscript preparation and submission Now you will have a manuscript that should pass muster at any medical journal, and you will not have to spend much longer fitting the paper to a journal’s specific requirements (for example, http://resources.bmj.com/bmj/authors) even if you have to try several journals sequentially Editors should not, however, use these reporting guidelines to reject studies that do not reach some fixed or arbitrary threshold for quality. In difficult and new areas of research, imperfectly conducted studies often provide good enough evidence to change policy or practice or to inform the next phase of research. Such studies deserve to be published, warts and all, but reporting guidelines point out where the warts are and how big they are. Using another bodily metaphor, Ian Needleman, director of London’s International Centre for Evidence-based Oral Health, said at the EQUATOR launch “research reporting is too often like swimwear: what it reveals is suggestive; what it conceals is vital.”

Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement

Abstract: Systematic reviews should build on a protocol that describes the rationale, hypothesis, and planned methods of the review; few reviews report whether a protocol exists. Detailed, well-described protocols can facilitate the understanding and appraisal of the review methods, as well as the detection of modifications to methods and selective reporting in completed reviews. We describe the development of a reporting guideline, the Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols 2015 (PRISMA-P 2015). PRISMA-P consists of a 17-item checklist intended to facilitate the preparation and reporting of a robust protocol for the systematic review. Funders and those commissioning reviews might consider mandating the use of the checklist to facilitate the submission of relevant protocol information in funding applications. Similarly, peer reviewers and editors can use the guidance to gauge the completeness and transparency of a systematic review protocol submitted for publication in a journal or other medium.

Nudge: Improving Decisions about Health, Wealth, and Happiness

Abstract: NUDGE: IMPROVING DECISIONS ABOUT HEALTH, WEALTH, AND HAPPINESS by Richard H. Thaler and Cass R. Sunstein Penguin Books, 2009, 312 pp, ISBN 978-0-14-311526-7This book is best described formally as a general explanation of and advocacy for libertarian paternalism, a term coined by the authors in earlier publications. Informally, it is about how leaders, systems, organizations, and governments can nudge people to do the things the nudgers want and need done for the betterment of the nudgees, or of society. It is paternalism in the sense that "it is legitimate for choice architects to try to influence people's behavior in order to make their lives longer, healthier, and better", (p. 5) It is libertarian in that "people should be free to do what they like - and to opt out of undesirable arrangements if they want to do so", (p. 5) The built-in possibility of opting out or making a different choice preserves freedom of choice even though people's behavior has been influenced by the nature of the presentation of the information or by the structure of the decisionmaking system. I had never heard of libertarian paternalism before reading this book, and I now find it fascinating.Written for a general audience, this book contains mostly social and behavioral science theory and models, but there is considerable discussion of structure and process that has roots in mathematical and quantitative modeling. One of the main applications of this social system is economic choice in investing, selecting and purchasing products and services, systems of taxes, banking (mortgages, borrowing, savings), and retirement systems. Other quantitative social choice systems discussed include environmental effects, health care plans, gambling, and organ donations. Softer issues that are also subject to a nudge-based approach are marriage, education, eating, drinking, smoking, influence, spread of information, and politics. There is something in this book for everyone.The basis for this libertarian paternalism concept is in the social theory called "science of choice", the study of the design and implementation of influence systems on various kinds of people. The terms Econs and Humans, are used to refer to people with either considerable or little rational decision-making talent, respectively. The various libertarian paternalism concepts and systems presented are tested and compared in light of these two types of people. Two foundational issues that this book has in common with another book, Network of Echoes: Imitation, Innovation and Invisible Leaders, that was also reviewed for this issue of the Journal are that 1 ) there are two modes of thinking (or components of the brain) - an automatic (intuitive) process and a reflective (rational) process and 2) the need for conformity and the desire for imitation are powerful forces in human behavior. …

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

Abstract: High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.