Identifying research waste from surgical research: a protocol for assessing compliance with the IDEAL framework and recommendations.

Introduction: Approximately £1130 billion was invested in research worldwide in 2016, and 9.6% of this was on biomedical research. However, about 85% of biomedical research investment is wasted.

The methodological quality of surgical randomized controlled trials: A cross-sectional systemic review.

Systematic reviews of RCTs have been developed to address end-users' needs and are regarded as the highest level of evidence. Flaws in the design, conduct and analyses of a systematic review can lead to erroneous conclusions and increase the research waste. We undertook a cross-sectional survey to identify the critical areas of weakness in systematic reviews for surgical interventions by AMSTAR 2.

IDEAL-D Framework for Device Innovation: A Consensus Statement on the Preclinical Stage.

Objective: To extend the IDEAL framework for device innovation, IDEAL-D, to include the preclinical stage of development (stage 0).

Background: In previous work, the IDEAL collaboration has proposed frameworks for new surgical techniques and complex therapeutic technologies, the central tenet being that development and evaluation can and should proceed together in an ordered and logical manner that balances innovation and safety.

Methods: Following agreement at the IDEAL Collaboration Council, a multidisciplinary working group was formed comprising 12 representatives from healthcare, academia, industry, and a patient advocate.

Identifying competing interest disclosures in systematic reviews of surgical interventions and devices: a cross-sectional survey.

Background: A competing interest is an important source of bias in research and disclosure is frequently employed as a strategy to manage it. Considering the importance of systematic reviews (SRs) and the varying prevalence of competing interests in different research fields, we conducted a survey to identify the range of competing interests in SRs assessing surgical interventions or devices and explored the association between the competing interest disclosures and authors' conclusions.

Methods: We retrieved SRs of surgical interventions and devices published in 2017 via PubMed.

The IDEAL framework in neurosurgery: a bibliometric analysis.

Background: The Idea, Development, Exploration, Assessment and Long-term study (IDEAL) framework was created to provide a structured way for assessing and evaluating novel surgical techniques and devices.

Objectives: The aim of this paper was to investigate the utilization of the IDEAL framework within neurosurgery, and to identify factors influencing implementation.

Methods: A bibliometric analysis of the 7 key IDEAL papers on Scopus, PubMed, Embase, Web of Science, and Google Scholar databases (2009-2019) was performed.

The IDEAL Reporting Guidelines: A Delphi Consensus Statement Stage Specific Recommendations for Reporting the Evaluation of Surgical Innovation.

Objective: The aim of this study was to define reporting standards for IDEAL format studies.

Background: The IDEAL Framework and Recommendations establish an integrated pathway for evaluation of new surgical techniques and complex therapeutic technologies. However guidance on implementation has been incomplete, and incorrect use is commonly seen.

Evolution of transanal total mesorectal excision according to the IDEAL framework.

Tremendous innovations have taken place in surgical procedures, but contrary to drug development, this process has been unregulated in the past. IDEAL promotes a structured framework for the safe implementation and assessment of a new surgical technique or intervention, by describing five stages for evaluating and reporting of innovations: , , , and . Transanal total mesorectal excision (TaTME) is a relatively new technique in rectal cancer surgery that has attracted huge interest and increasing adoption worldwide.

Appraising the uptake and use of the IDEAL Framework and Recommendations: A review of the literature.

Introduction: Evaluation of new surgical innovations is complex and variably regulated, and historically the quality of surgical studies has been criticized. The IDEAL (Idea, Development, Exploration, Assessment, Long-term monitoring) Framework was established to provide a pathway for evaluating surgical innovations at each stage of their development in order to produce high quality surgical research. Since the inception of IDEAL in 2009, there has been no assessment of its use.

A protocol for the development of reporting guidelines for IDEAL stage studies.

Background: New surgical procedures, devices and other complex interventions need robust evaluation for safety, efficacy and effectiveness. The IDEAL Framework and Recommendations lay out a pathway to achieve this and offer general guidance on how studies at each stage should be reported. However, researchers require some assistance in translating theory into practice.

No Surgical Innovation Without Evaluation: Evolution and Further Development of the IDEAL Framework and Recommendations.

Objective: To update, clarify, and extend IDEAL concepts and recommendations.

Background: New surgical procedures, devices, and other complex interventions need robust evaluation for safety, efficacy, and effectiveness. Unlike new medicines, there is no internationally agreed evaluation pathway for generating and analyzing data throughout the life cycle of surgical innovations.

Evidence-Based Evaluation of Practice and Innovation in Physical Therapy Using the IDEAL-Physio Framework.

The IDEAL framework is an established method for initial and ongoing evaluations of innovation and practice for complex health care interventions. First derived for surgical sciences and embedded at a global level for evaluating surgery/surgical devices, the IDEAL framework is based on the principle that innovation and evaluation in clinical practice can, and should, evolve together in an ordered manner: from conception to development and then to validation by appropriate clinical studies and, finally, longer-term follow-up. This framework is highly suited to other complex, nonpharmacological interventions, such as physical therapist interventions.

Adapting the IDEAL Framework and Recommendations for medical device evaluation: A modified Delphi survey.

Introduction: Current regulatory systems for medical device marketing approval lack adequate requirements for evidence of safety and efficacy. The Total Product Life Cycle (TPLC) concept, with clinical use and marketing expanding as evidence develops, has won support, but lacks a template to define evidence requirements at different stages. The IDEAL Framework & Recommendations, originally developed for new surgical procedures, might provide such a template, but may require modification.

Relation of completeness of reporting of health research to journals' endorsement of reporting guidelines: systematic review.

Objective: To assess whether the completeness of reporting of health research is related to journals' endorsement of reporting guidelines.

Design: Systematic review.

Data Sources: Reporting guidelines from a published systematic review and the EQUATOR Network (October 2011).

WITHDRAWN: Benzodiazepines and related drugs for insomnia in palliative care.

This review is out of date, and the original authors are no longer available to update it. The editorial group responsible for this previously published document have withdrawn it from publication.

Reporting characteristics of non-primary publications of results of randomized trials: a cross-sectional review.

Background: For a randomized trial, the primary publication is usually the one which reports the results of the primary outcome and provides consolidated data from all study centers. Other aspects of a randomized trial's findings (that is, non-primary results) are often reported in subsequent publications.

Methods: We carried out a cross-sectional review of the characteristics and type of information reported in non-primary reports (n = 69) of randomized trials (indexed in PubMed core clinical journals in 2009) and whether they report pre-specified or exploratory analyses.

Does journal endorsement of reporting guidelines influence the completeness of reporting of health research? A systematic review protocol.

Background: Reporting of health research is often inadequate and incomplete. Complete and transparent reporting is imperative to enable readers to assess the validity of research findings for use in healthcare and policy decision-making. To this end, many guidelines, aimed at improving the quality of health research reports, have been developed for reporting a variety of research types.

Are peer reviewers encouraged to use reporting guidelines? A survey of 116 health research journals.

Background: Pre-publication peer review of manuscripts should enhance the value of research publications to readers who may wish to utilize findings in clinical care or health policy-making. Much published research across all medical specialties is not useful, may be misleading, wasteful and even harmful. Reporting guidelines are tools that in addition to helping authors prepare better manuscripts may help peer reviewers in assessing them.

Reporting of participant flow diagrams in published reports of randomized trials.

Background: Reporting of the flow of participants through each stage of a randomized trial is essential to assess the generalisability and validity of its results. We assessed the type and completeness of information reported in CONSORT (Consolidated Standards of Reporting Trials) flow diagrams published in current reports of randomized trials.

Methods: A cross sectional review of all primary reports of randomized trials which included a CONSORT flow diagram indexed in PubMed core clinical journals (2009).

Transparent and accurate reporting increases reliability, utility, and impact of your research: reporting guidelines and the EQUATOR Network.

Although current electronic methods of scientific publishing offer increased opportunities for publishing all research studies and describing them in sufficient detail, health research literature still suffers from many shortcomings. These shortcomings seriously undermine the value and utility of the literature and waste scarce resources invested in the research. In recent years there have been several positive steps aimed at improving this situation, such as a strengthening of journals' policies on research publication and the wide requirement to register clinical trials.