Research Wastage Research Articles

To adopt or adapt an existing neonatal core outcome set in Kenya: a study protocol

BackgroundDevelopment and use of core outcome set(s) (COS) in research can reduce research wastage by ensuring that a minimum set of outcomes are always reported on. Neonatal morbidity and mortality are a big burden in low- and middle-income countries (LMICs). Research is continuously being undertaken to reduce this burden. Currently, there is no COS for neonatal research in LMICs but there exists one for neonatal research in high-income countries (HICs).ObjectivesTo determine outcomes that are useful for neonatal care in Kenya to inform whether an existing COS should be adopted or adapted. To assess the feasibility of a routine data collection system to collect data of the agreed-on COS.MethodsA review of existing literature on neonatal research in LMICs followed by a qualitative study of key stakeholders in neonatal care. To explore whether to adapt or adopt, in two hospitals, two focus group discussions with 6–8 parents/caregivers will be undertaken (one each in two hospitals). Key informant interviews will also be conducted with 6 health care providers in each of the hospitals. At the policy-making level, we will conduct 10 key informant interviews. Qualitative data will be analyzed thematically. A consensus meeting will be undertaken with key stakeholders, who will be presented with an overview of the COS developed for HICs, key findings from the literature, and the qualitative study to determine context-appropriate COS. The agreed-on outcomes will be counterchecked against the case records in the two hospitals. The feasibility of collecting the outcomes on a routine electronic research database, the Clinical Information Network that collects standardized data at admission and discharge, will be explored. The congruence (or not) of the outcomes will be documented and be used to enrich the discussion and provide a snapshot of the feasibility of the health information system to collect routine data on the COS.ConclusionsA COS for use in neonatal care in Kenya will help enhance outcome measurements and reporting not just in research but also in routine practice. This will enhance the comparability of interventions in trials and routine settings leading to reduced research wastage and likely improved quality of care. Additionally, the methodology used for this work can be adopted in other settings as a means of adopting or adapting an existing COS.

Establishing reporting standards for participant characteristics in post-stroke aphasia research: An international e-Delphi exercise and consensus meeting

Objective To establish international, multidisciplinary expert consensus on minimum participant characteristic reporting standards in aphasia research (DESCRIBE project). Methods An international, three-round e-Delphi exercise and consensus meeting, involving multidisciplinary researchers, clinicians and journal editors working academically or clinically in the field of aphasia. Results Round 1 of the DESCRIBE e-Delphi exercise (n = 156) generated 113 items, 20 of which reached consensus by round 3. The final consensus meeting (n = 19 participants) established DESCRIBE's 14 participant characteristics that should be reported in aphasia studies: age; years of education; biological sex; language of treatment/testing; primary language; languages used; history of condition(s) known to impact communication/cognition; history of previous stroke; lesion hemisphere; time since onset of aphasia; conditions arising from the neurological event; and, for communication partner participants, age, biological sex and relationship to person with aphasia. Each characteristic has been defined and matched with standard response options to enable consistent reporting. Conclusion Aphasia research studies should report the 14 DESCRIBE participant characteristics as a minimum. Consistent adherence to the DESCRIBE minimum reporting standard will reduce research wastage and facilitate evidence-based aphasia management by enabling replication and collation of research findings, and translation of evidence into practice.

Reducing research wastage by starting off on the right foot: optimally framing the research question.

Strongly framed research questions are clear as to the population (P), the exposures or interventions (E/I), comparison groups (C), outcomes (O), time when relevant (T), and what the investigator wants to know. A solid framework sets up the measurement model, analysis, and anticipated results. The purpose of this study was to estimate the extent to which research questions in journals that focused on patient-reported outcome measures (PROM) and quality of life (QOL) are clear. All 440 research articles published in four PROM journals in 2020. excluding reviews, psychometric, and qualitative papers, were reviewed. Research questions were classified as: (i) adequately framed (ii) poorly framed; or (iii) unframed based on clarity criteria. Examples from each journal were presented and reframed to match results in the article. Of 440 articles, 195 (44.3%) were classified as adequately framed; 230 (52.2%) as poorly framed; and 15 (3.4%) as unframed. There was heterogeneity across journals (Chi-square: 20.8; 6 df; p = 0.002). Only 29% were framed according to what the investigators wanted to know; 72% were framed like a "to do" list; and 6% were framed as a research agenda. Almost half of the questions were poorly framed or unframed a practice that could contribute to research wastage. Even "adequately framed" questions rarely stated what they wanted to know a priori, increasing the risk of biased reporting. Researchers, reviewers, and editors should encourage the use established frameworks for research questions.

CORE OUTCOME SETS AND DENTAL PATIENT REPORTED OUTCOMES.

In clinical research, outcomes are the results or 'endpoints' that are measured to assess whether clinical interventions have been successful or whether one treatment works better than another. There are a vast number of outcomes that have been reported in dental trials; the number, diversity and questionable relevance of these outcomes can lead to research wastage. Ultimately, this can lead to uncertainty for patients and dental professionals as to the most effective prevention and treatment options available as the evidence available may not use outcomes important to them. This article introduces the reader to core outcome sets (COS), covering the background to this area of research; their purpose and role; as well as the methodology of development. The authors reflect on their experience of leading the development of a core outcome set for periodontal trials and we highlight other dental COSs already developed and their inclusion of dental Patient Reported Outcomes (dPROs).

Facilitating the planning and evaluation of narrative intervention reviews: Systematic Transparency Assessment in Intervention Reviews (STAIR)

Narrative reviews offer a flexible way to report intervention results and comprise the majority of reviews published in top medical journals. However variations in their transparency pose evaluation challenges, compromising their value and potentially resulting in research wastage. Calls have been made to reduce the number of narrative reviews published. Others argue narrative reviews provide an important platform and should even be placed on an equal footing to systematic reviews. We believe narrative intervention reviews can provide a vital perspective when transparent, and thus support Systematic Transparency Assessment in Intervention Reviews (STAIR). This research evaluates the transparency of 172 health-related narrative and literature reviews (K = 172), by assessing how they communicate information about the interventions they review. Eight points supporting transparency, relating to sample sizes, traceability, article numbers, and references, were assessed. Half of the reviews reported on at least four of the eight points, but 24% reported on none. Only 56% of the reviews clearly communicated full references. The STAIR* (Sample sizes, Traceability, Article numbers, Intervention numbers, References*) checklist comprises five sections, and nine points. It is proposed as a convenient tool to address STAIR and complement existing review guidelines to assist authors in planning, reviewers in evaluating, and scholars in utilising narrative reviews. The objectives of STAIR* are to: 1) encourage narrative review transparency and readability, 2) facilitate the incorporation of narrative reviews results into other research; and 3) enrich narrative review methodology with a checklist to guide, and evaluate, intervention reviews.

TRaiTS: Template for Reporting of Trials in Short format - swine examples

A checklist for guiding authors in comprehensive reporting of swine individually or cluster-randomized controlled trials for journal abstracts or conference proceedings is shown. It is recommended that authors, conference organizers, and journal editors adopt this guideline to enhance study interpretation and use and reduce research wastage.

The usability and applicability of knowledge translation theories, models, and frameworks for research in the context of a national health service

BackgroundTranslating research findings into service improvements for patients and/or policy changes is a key challenge for health service organizations. The Health Service Executive (HSE) in Ireland launched the Action Plan for Health Research 2019–2029, as reported by Terrés (HSE, Dublin, 2019), one of the goals of which is to maximize the impact of the research that takes place within the service to achieve improvements in patient care, services, or policy change.The purpose of this research is to review the literature on knowledge translation theories, models, and frameworks (TMFs) and to assess the suitability of the TMFs for HSE use, selecting one or more for this purpose. The aim is to produce guidance for HSE researchers and other health services staff, validate the usability of the framework(s) with researchers, and review and implement the guidance. It was hoped that identifying a suitable methodology would provide the means to increase the uptake and application of research findings, and reduce research wastage. This paper reports on the first part of the study: the review, assessment, and selection of knowledge translation TMFs for a national health service.MethodsAn interdisciplinary working group of academic experts in implementation science, research wastage, and knowledge translation, along with key representatives from research funders (Health Research Board) and HSE personnel with expertise in quality improvement and research management, undertook a three-stage review and selection process to identify a knowledge translation TMF that would be suitable and usable for HSE purposes. The process included a literature review, consensus exercise, and a final consensus workshop. The review group adopted the Theory Comparison and Selection Tool (T-CaST) developed by Birken et al. (Implement Sci 13: 143, 2018) to review knowledge translation theories, models, and frameworks.ResultsFrom 247 knowledge translation TMFs initially identified, the first stage of the review identified 18 that met the criteria of validity, applicability, relevance, usability, and ability to be operationalized in the local context. A further review by a subgroup of the working group reduced this number to 11. A whole-group review selected six of these to be reviewed at a facilitated consensus workshop, which identified three that were suitable and applicable for HSE use. These were able to be mapped onto the four components of the HSE knowledge translation process: knowledge creation, knowledge into action, transfer and exchange of knowledge, and implementation and sustainability.ConclusionThe multiplicity of knowledge translation TMFs presents a challenge for health service researchers in making decisions about the appropriate methods for disseminating their research. Building a culture that uses research knowledge and evidence is important for organizations seeking to maximize the benefits from research. Supporting researchers with guidance on how to disseminate and translate their research can increase the uptake and application of research findings.The use of robust selection criteria enabled the HSE to select relevant TMFs and develop a process for increasing the dissemination and translation of research knowledge. The guidance developed to inform and educate researchers and knowledge users is expected to increase organizational capacity to promote a culture of research knowledge and evidence use within the HSE.

Developing a core outcome set for periodontal trials.

There is no agreement which outcomes should be measured when investigating interventions for periodontal diseases. It is difficult to compare or combine studies with different outcomes; resulting in research wastage and uncertainty for patients and healthcare professionals. Develop a core outcome set (COS) relevant to key stakeholders for use in effectiveness trials investigating prevention and management of periodontal diseases. Mixed method study involving literature review; online Delphi Study; and face-to-face consensus meeting. Key stakeholders: patients, dentists, hygienist/therapists, periodontists, researchers. The literature review identified 37 unique outcomes. Delphi round 1: 20 patients and 51 dental professional and researchers prioritised 25 and suggested an additional 11 outcomes. Delphi round 2: from the resulting 36 outcomes, 13 patients and 39 dental professionals and researchers prioritised 22 outcomes. A face-to-face consensus meeting was hosted in Dundee, Scotland by an independent chair. Eight patients and six dental professional and researchers participated. The final COS contains: Probing depths, Quality of life, Quantified levels of gingivitis, Quantified levels of plaque, Tooth loss. Implementation of this COS will ensure the results of future effectiveness trials for periodontal diseases are more relevant to patients and dental professionals, reducing research wastage. This could reduce uncertainty for patients and dental professionals by ensuring the evidence used to inform their choices is meaningful to them. It could also strengthen the quality and certainty of the evidence about the relative effectiveness of interventions. COMET Database: http://www.comet-initiative.org/studies/details/265?result=true.

Trends in clinical trial registration in sub-Saharan Africa between 2010 and 2020: a cross-sectional review of three clinical trial registries

ObjectiveProspective registration of clinical trials is an ethical, scientific, and legal requirement that serves several functions, including minimising research wastage and publication bias. Sub-Saharan Africa (SSA) is increasingly hosting clinical trials over the past few years, and there is limited literature on trends in clinical trial registration and reporting in SSA. Therefore, we set out to determine the trends in clinical trials registered in SSA countries between 2010 and July 2020.MethodsA cross-sectional study design was used to describe the type of clinical trials that are conducted in SSA from 1 January 2010 to 31 July 2020. The registries searched were ClinicalTrials.gov (CTG), the Pan African Clinical Trials Register (PACTR), and the International Standard Randomized Controlled Trial Number (ISRCTN). Data were extracted into Excel and imported into STATA for descriptive analysis.ResultsCTG had the highest number of registered trials at 2622, followed by PACTR with 1501 and ISRCTN with 507 trials. Trials were observed to increase gradually from 2010 and peaked at 2018–2019. Randomised trials were the commonest type, accounting for at least 80% across the three registries. Phase three trials investigating drugs targeted at infections/infestations were the majority. Few completed trials had their results posted: 58% in ISRCTN and 16.5% in CTG, thus suggesting reporting bias.ConclusionDespite the gradual increase in clinical trials registered during the period, recent trends suggest a drop in the number of trials registered across the region. Strengthening national and regional regulatory capacity will improve clinical trial registration and minimise reporting bias in completed clinical trials.

77 The Development of Core Outcome Sets and Common Data Elements in Clinical Neurosciences: A Scoping Review

Abstract Introduction The use of core outcome sets (COS) and common data elements (CDEs) minimises research wastage by increasing the cross-comparison and meta-analysis of study findings. Our study sought to identify the clinical neuroscience subspecialties that have developed COS and CDEs, the countries of origin of authors, and the process through which COS and CDEs were developed. Method A search between 2000-2020 of the top 40 Impact Factor neurosurgical and neurological journals was conducted. A scoping review was performed in accordance with the PRISMA-ScR Checklist. Results Our search returned 169 papers, of which 35 were eligible for inclusion. The USA published the majority of papers (20/35). The papers mostly related to neurosurgery (30/35), with the most common neurosurgical sub-specialty being traumatic brain injury (14/35). There is an increasing publication trend over time, with 12 papers published in 2019. Five papers were systematic reviews conducting with the intention of COS/CDE development. 27 papers reported CDE development and 2 papers reported COS development. The COS development papers utilised international consensus meetings and adhered to international development statements. Conclusions COS and CDEs are increasingly being developed within clinical neurosciences. There is a need for greater international collaboration with regards to COS and CDEs development.

P121 The development of Core Outcome Sets and Common Data Elements in clinical neurosciences: a scoping review

BackgroundCore Outcome Sets (COS) are a consensus-based agreed minimum set of outcomes that should be measured and reported in all studies within a research field. Common Data Elements (CDEs) are the minimum data points that should be collected regarding the characteristics of population, condition and intervention. The use of COS and CDEs minimises research wastage by increasing the cross-comparison and meta-analysis of study findings.ObjectiveThe primary objective was to collate and describe the current process of developing core outcome sets and common data elements in published research pertaining to clinical neurosciences. The secondary objective was to identify the clinical neuroscience subspecialties that have developed COS and CDEs, the countries of origin of authors, and the process through which COS and CDEs were developed.DesignA search between 2000-2020 of the top 40 Impact Factor neurosurgical and neurological journals was conducted. A scoping review was performed in accordance with the PRISMA-ScR Checklist.ResultsOur search returned 169 papers, of which 35 were eligible for inclusion in the present study. The USA published the majority of papers (20/35). The papers mostly related to neurosurgery (30/35), with the most common neurosurgical sub-specialty being traumatic brain injury (14/35) and subarachnoid haemorrhage (10/35). There is an increasing publication trend over time, with 12 papers published in 2019. COS and CDE development is an international collaborative process, with authors from a number of different countries. Five papers were systematic reviews conducting with the intention of COS/CDE development. 27 papers reported CDE development and 2 papers reported COS development (aphasia and non-specific low back pain). The COS development papers utilised international consensus meetings and adhered to international development statements.ConclusionsCOS and CDEs are an essential research tool to reduce research wastage and ultimately improve patient outcomes through homogenous outcome reporting, aligned with patient-derived outcomes. COS and CDEs are increasingly being developed within clinical neurosciences.

Harmonizing research outcomes for polycystic ovary syndrome (HARP), a marathon not a sprint: current challenges and future research need.

Investing in clinical research and evidence-based medicine has helped to improve the care for women with polycystic ovary syndrome (PCOS). However, several important questions remain unanswered on the optimal prevention and management strategies for PCOS. Addressing this uncertainty is often hindered by suboptimal research conduct leading to inefficient evidence synthesis and research wastage. PCOS research is often practised by varied specialized teams in silo leading to disharmonious and fragmented efforts neglecting the lifelong impact of PCOS on women's wellbeing. Poor engagement among key stakeholders and lay consumers continues to limit the impact and benefits of research to society. Selective reporting on surrogate outcomes with a 'significant' P-value is a common malpractice in PCOS outputs. Effective adoption of the harmonizing research outcomes for PCOS (HARP) core outcome set is needed to minimize heterogeneity in reporting and promote research excellence. Small single-centre studies offer limited value to assess the varied PCOS phenotypes. Efficient large scale data-sharing is needed to address complex research questions and glean the benefits of big data research. We propose a roadmap to address these challenges and remedy future research need by promoting patient and public involvement in PCOS research to guide research efforts and address real patients' needs; engaging all key stakeholder groups to promote a multi-disciplinary lifelong approach to new research; continuously refining research needs and priorities to revise the knowledge gap and allocate resources judiciously; standardizing outcomes definitions and measurement tools to harmonize reporting and promote excellence in research; and by investing in large data-sharing infrastructure to facilitate big data research and govern ethical data sharing.

Protocol for development of a core outcome set for menopausal symptoms (COMMA).

Objective:Menopause is the natural cessation of menstruation and may be accompanied by troublesome symptoms including hot flushes and night sweats (vasomotor symptoms) and genitourinary symptoms. Randomized trials evaluating the safety and effectiveness of interventions for these symptoms have reported a wide range of outcomes and used inconsistent measures. This variation precludes comparing and combining data from different trials. To overcome this limitation, we will develop a Core Outcome Set for Menopausal Symptoms.Methods:We will systematically review the literature to identify the outcomes reported in the interventional trials for vasomotor and genitourinary symptoms. This list will be entered into a two-round modified Delphi survey to be completed by clinicians, researchers, and consumers (women who have experienced menopause). Participants will score outcomes on a nine-point scale from “not important” to “critically important.” Representatives from each stakeholder group will then meet to discuss the results and finalize the Core Outcome Set. Ethics approval was not required as this was considered service evaluation and development. The study is registered with the Core Outcome Measures in Effectiveness Trials Initiative (http://www.comet-initiative.org/studies/details/917).Results:An agreed upon set of minimum outcomes and outcome measures will facilitate combining and comparing findings from future trials of treatments for menopausal symptoms.Conclusions:This Core Outcome Set will better enable women and clinicians to select effective treatments, improve the quality of trial reporting, reduce research wastage, and improve care for women with troublesome menopausal symptoms.Video Summary:

The current status of clinical trials in emergency gastrointestinal surgery: A systematic analysis of contemporary clinical trials.

Emergency gastrointestinal surgery (EGS) conditions represent a significant healthcare burden globally requiring emergency operations that are associated with mortality rates as high as 80%. EGS is currently focused on quality improvement and internal audits, which occurs at a national or local level. An appreciation of what EGS trials are being conducted is important to reduce research wastage and develop coordinated research strategies in surgery. The primary aim of this study was to identify and quantify recent and active trials in EGS. The secondary aim was to identify conditions of interest and which aspects of care were being modified. A systematic search of WHO, UK, US, Australian, and Canadian trials databases was undertaken using broad terms to identify studies addressing emergency abdominal surgery and specific high-risk diagnoses. Studies registered between 2013 and 2018 were eligible for inclusion. Data on study topic, design, and funding body were collected. Interventions were classified into "perioperative", "procedural", "postoperative", "non-surgical", and "other" categories. Searches identified 5603 registered trials. After removal of duplicates, 4492 studies remained and 42 were eligible for inclusion. Almost 50% of trials were located in Europe and 17% (n = 7) in the United States. The most common condition addressed was acute appendicitis (n = 11), with the most common intervention being procedure based (n = 23). Hospital-based funding was the most common funder (n = 30). There is large disparity in the number of surgical trials in emergency surgery, which are primarily focused on high-volume conditions. More research is needed into high-mortality conditions. Systematic review, level III.

Is there any hope that we can reduce research wastage and prevent publication bias?

In order to fulfil the ethical contract between researchers and the participants of research, trial results need to be disseminated. Patients and carers have identified publication and dissemination as one of the key areas of research wastage that they are concerned about (1). Research wastage is also of concern to public funders with an analysis looking at 9 years of EU-funded health projects with a resultant wastage of 570.2 million euros resulting in no detectable academic output (2).