scholarly journals A survey of knowledge, perceptions and use of core outcome sets among clinical trialists

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Chiara Bellucci ◽  
Karen Hughes ◽  
Elaine Toomey ◽  
Paula R. Williamson ◽  
Karen Matvienko-Sikar
Keyword(s):  
Online Survey ◽  
Survey Design ◽  
Outcome Measurement ◽  
Controlled Trial ◽  
Clear Understanding ◽  
Core Outcome ◽  
Selective Outcome Reporting ◽  
Core Outcome Sets ◽  
Randomised Controlled ◽  
And Training

Abstract Background Core outcome sets (COS) are standardised sets of outcomes, which represent the minimum outcomes that should be measured and reported in clinical trials. COS can enhance comparability across health trials by reducing heterogeneity of outcome measurement and reporting and potentially minimising selective outcome reporting. Examining what researchers involved in trials know and think about COS is essential to increase awareness and promote COS uptake. The aim of this study is therefore to examine clinical trialists’ knowledge, perceptions and experiences of COS. Methods An online survey design was used. Participants were clinical trialists, operationalised for the current study as researchers named as the contact person on a trial registered on the International Standard Randomised Controlled Trial Number (ISRCTN) Trial repository between 1 January 2019 and 21 July 2020. Survey items assessed clinical trialists’ familiarity with and understanding of COS, along with experiences of COS use and development. Results Of 1913 clinical trialists contacted to participate, 62 (3%) completed the survey. Forty (65%) participants were familiar with COS and, of those familiar with COS, 21 (55%) had been involved in a trial that used a COS. Of clinical trialists who used COS in a trial(s), less than half (n = 9, 41%) reported that all COS outcomes were used. The main barriers to using COS are poor knowledge about COS (n = 43, 69%) and difficulties identifying relevant COS (n = 42, 68%). Clinical trialists also reported perceptions of COS as restrictive and often containing too many outcomes. The main enablers to using COS are clear understanding (n = 51, 82%) and perceived importance of COS (n = 44, 71%). Conclusions Enhancing clinical trialists’ use of all COS outcomes is needed to reduce outcome heterogeneity and enhance comparability across trial findings. Enhancing awareness of COS importance among researchers and funders is needed to ensure that COS are developed and used by clinical trialists. Education and training may further promote awareness and understanding of COS.

scholarly journals A Survey of Knowledge, Perceptions and Use of Core Outcome Sets among Clinical Trialists

2021 ◽  
Author(s):  
Chiara Bellucci ◽  
Karen Hughes ◽  
Elaine Toomey ◽  
Paula R Williamson ◽  
Karen Matvienko-Sikar
Keyword(s):  
Online Survey ◽  
Survey Design ◽  
Outcome Measurement ◽  
Controlled Trial ◽  
Clear Understanding ◽  
Core Outcome ◽  
Selective Outcome Reporting ◽  
Core Outcome Sets ◽  
Randomised Controlled ◽  
And Training

Abstract Introduction: Core outcome sets (COS) are standardised sets of outcomes, which represent the minimum outcomes that should be measured and reported in clinical trials. COS can enhance comparability across health trials by reducing heterogeneity of outcome measurement and reporting, and potentially minimising selective outcome reporting. Examining what researchers involved in trials know and think about COS is essential to increase awareness and promote COS uptake. The aim of this study is therefore to examine clinical clinical trialists’ knowledge, perceptions and experiences of COS. Methods: An online survey design was used. Participants were clinical trialists, operationalised for the current study as researchers named as the contact person on a trial registered on the International Standard Randomised Controlled Trial Number (ISRCTN) Trial repository between 01/01/2019 and 21/07/2020. Survey items assessed clinical trialists’ familiarity with, and understanding of COS, along with experiences of COS use and development. Results: Of 1913 clinical trialists contacted to participate, 62 (3%) completed the survey. 65% of participants were familiar with COS and, of those familiar with COS, 55% had been involved in a trial that used a COS. Of clinical trialists who used COS in a trial(s), less than half (41%) reported that all COS outcomes were used. The main barriers to using COS are poor knowledge about COS (69%) and difficulties identifying relevant COS (68%). Clinical trialists also reported perceptions of COS as restrictive and often containing too many outcomes. The main enablers to using COS are clear understanding (82%) and perceived importance of COS (71%). Conclusion: Education and training can further promote awareness and understanding of COS. Enhancing clinical trialists’ use of all COS outcomes is needed to reduce outcome heterogeneity and enhance comparability across trial findings. Enhancing awareness of COS importance among researchers and funders is needed to ensure that COS are developed and used by clinical trialists.

scholarly journals Uptake of core outcome sets by clinical trialists publishing in major medical journals: Protocol

2020 ◽  
Vol 3 ◽  
pp. 53 ◽  
Author(s):  
Karen Matvienko-Sikar ◽  
Kerry Avery ◽  
Jane Blazeby ◽  
Karen Hughes ◽  
Pamela Jacobson ◽  
...  
Keyword(s):  
New England ◽  
Online Survey ◽  
Outcome Measurement ◽  
Late Phase ◽  
Specific Area ◽  
Selective Reporting ◽  
Core Outcome ◽  
Future Health ◽  
Medical Journals ◽  
Core Outcome Sets

Background: Outcome heterogeneity, selective reporting, and choosing outcomes that do not reflect needs and priorities of stakeholders, limit the examination of health intervention effects, particularly in late phase trials. Core outcome sets (COS) are a proposed solution to these issues. A COS is an agreed-upon, standardised set of outcomes that should be measured and reported as a minimum in all trials in a specific area of health or healthcare. COS are intended to increase standardisation of outcome measurement and reporting to better enable comparisons between, and synthesis of findings of trials in a particular health area.  Methods: This study will examine late phase trials, published between October 2019 and March 2020 (inclusive), in the following five medical journals: New England Journal of Medicine, Journal of the American Medical Association, Lancet, BMJ, and Annals of Internal Medicine. Trials will be examined to determine if they refer to a COS, and whether they use a COS. Trialists for each identified trial will subsequently be contacted to complete an online survey examining trialists’ awareness of, and decisions to search for and use a COS. Discussion: This study will provide important information on uptake of COS by later phase trialists in major medical journals, and the views of these trialists on COS use in trials. These findings will inform approaches to increasing awareness and uptake of COS in future health trials.

scholarly journals Uptake of core outcome sets by clinical trialists publishing in major medical journals: Protocol

2021 ◽  
Vol 3 ◽  
pp. 53
Author(s):  
Karen Matvienko-Sikar ◽  
Kerry Avery ◽  
Jane Blazeby ◽  
Karen Hughes ◽  
Pamela Jacobsen ◽  
...  
Keyword(s):  
New England ◽  
Online Survey ◽  
Outcome Measurement ◽  
Late Phase ◽  
Specific Area ◽  
Selective Reporting ◽  
Core Outcome ◽  
Future Health ◽  
Medical Journals ◽  
Core Outcome Sets

Background: Outcome heterogeneity, selective reporting, and choosing outcomes that do not reflect needs and priorities of stakeholders, limit the examination of health intervention effects, particularly in late phase trials. Core outcome sets (COS) are a proposed solution to these issues. A COS is an agreed-upon, standardised set of outcomes that should be measured and reported as a minimum in all trials in a specific area of health or healthcare. COS are intended to increase standardisation of outcome measurement and reporting to better enable comparisons between, and synthesis of findings of trials in a particular health area.  Methods: This study will examine late phase trials, published between October 2019 and March 2020 (inclusive), in the following five medical journals: New England Journal of Medicine, Journal of the American Medical Association, Lancet, BMJ, and Annals of Internal Medicine. Trials will be examined to determine if they refer to a COS, and whether they use a COS. Trialists for each identified trial will subsequently be contacted to complete an online survey examining trialists’ awareness of, and decisions to search for and use a COS. Discussion: This study will provide important information on uptake of COS by later phase trialists in major medical journals, and the views of these trialists on COS use in trials. These findings will inform approaches to increasing awareness and uptake of COS in future health trials.

Auricular Acupuncture for Pre-Exam Anxiety in Medical Students: A Prospective Observational Pilot Investigation

2016 ◽  
Vol 34 (2) ◽  
pp. 90-94 ◽  
Author(s):  
Catharina Klausenitz ◽  
Thomas Hesse ◽  
Henriette Hacker ◽  
Klaus Hahnenkamp ◽  
Taras Usichenko
Keyword(s):  
Medical Students ◽  
Outcome Measurement ◽  
Controlled Trial ◽  
Final Analysis ◽  
Auricular Acupuncture ◽  
Before And After ◽  
Pilot Investigation ◽  
Exam Anxiety ◽  
Randomised Controlled ◽  
To Receive

Objective Auricular acupuncture (AA) is effective for the treatment of preoperative anxiety. We aimed to study the feasibility and effects of AA on exam anxiety in a prospective observational pilot study. Methods Healthy medical students received bilateral AA using indwelling fixed needles at points MA-IC1, MA-TF1, MA-SC, MA-AH7, and MA-T on the day before an anatomy exam. The needles were removed after the exam. Anxiety levels were measured using the State-Trait-Anxiety Inventory (STAI) and a 100 mm visual analogue scale (VAS-100) before and after the AA intervention and once again immediately before the exam. The duration of sleep on the night before the exam was recorded and compared to that over the preceding 1 week and 6 months (all through students’ recollection). In addition, blood pressure, heart rate and the acceptability of AA to the students were recorded. Results Ten students (all female) were included in the final analysis. All tolerated the needles well and stated they would wish to receive AA again for exam anxiety in the future. Exam anxiety measured using both STAI and VAS-100 decreased by almost 20% after AA. Conclusions AA was well accepted, the outcome measurement was feasible, and the results have facilitated the calculation of the sample size for a subsequent randomised controlled trial.

scholarly journals The PIT: SToPP Trial—A Feasibility Randomised Controlled Trial of Home-Based Physiotherapy for People with Parkinson's Disease Using Video-Based Measures to Preserve Assessor Blinding

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Emma Stack ◽  
Helen Roberts ◽  
Ann Ashburn
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Outcome Measurement ◽  
Controlled Trial ◽  
Video Data ◽  
Video Production ◽  
Control Group ◽  
Group Participant ◽  
Home Based ◽  
Randomised Controlled

Purpose. To trial four-week's physiotherapy targeting chair transfers for people with Parkinson's disease (PwPD) and explore the feasibility of reliance on remote outcome measurement to preserve blinding.Scope. We recruited 47 PwPD and randomised 24 to a focused home physiotherapy programme (exercise, movement strategies, and cueing) and 23 to a control group. We evaluated transfers (plus mobility, balance, posture, and quality of life) before and after treatment and at followup (weeks 0, 4, 8, and 12) from video produced by, and questionnaires distributed by, treating physiotherapists. Participants fed back via end-of-study questionnaires. Thirty-five participants (74%) completed the trial. Excluding dropouts, 20% of questionnaire data and 9% of video data were missing or unusable; we had to evaluate balancein situ. We noted trends to improvement in transfers, mobility, and balance in the physiotherapy group not noted in the control group. Participant feedback was largely positive and assessor blinding was maintained in every case.Conclusions. Intense, focused physiotherapy at home appears acceptable and likely to bring positive change in those who can participate. Remote outcome measurement was successful; questionnaire followup and further training in video production would reduce missing data. We advocate a fully powered trial, designed to minimise dropouts and preserve assessor blinding, to evaluate this intervention.

scholarly journals Evaluation of a prescription support-tool for chronic management of oral antithrombotic combinations in adults using clinical vignettes: protocol of a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e025544 ◽  
Author(s):  
Lorene Zerah ◽  
Dominique Bonnet-Zamponi ◽  
Paul Frappé ◽  
Marie Hauguel-Moreau ◽  
Yann De Rycke ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Online Survey ◽  
Mixed Model ◽  
Controlled Trial ◽  
Real Life ◽  
Bleeding Events ◽  
Support Tool ◽  
Clinical Vignettes ◽  
Randomised Controlled ◽  
The Impact

IntroductionImproving the appropriateness of prescriptions of oral antithrombotic (AT) drugs, especially AT combinations, is crucial because these drugs are implicated in bleeding events. We developed a prescription support-tool synthesising guidelines on chronic management of oral AT combinations. Our main objective is to assess the impact of this tool on improving the prescription of oral ATs to comply with guidelines.Methods and analysisA randomised controlled trial will be conducted among French general practitioners and cardiologists involved in outpatient settings. Physicians will be invited to participate to an online survey by email via physician associations, social networks or word of mouth. They will be randomised to two arms: the experimental arm (access to the prescription support-tool) or the control arm (no prescription support-tool). Then, all participants will be presented three different clinical vignettes illustrating outpatient clinical situations and will be asked to propose prescriptions for each vignette (number of ATs, type, dosage and duration). A computer-generated randomisation scheme implemented in the online survey will be used to allocate physicians to the experimental or control arm and then stratified by medical specialty. The primary outcome will be fully appropriate prescription of oral ATs ie, that comply with the guidelines in terms of number of drugs, drug class, dosage and duration. To demonstrate a 5% increase in this proportion, we will need to include a minimum of 230 physicians per arm. A logistic mixed model with a clinical vignette-effect and a physician-effect nested in the arm of the study will be used.Ethics and disseminationTheInstitutional Review Boardof Inserm (IRB00003888) approved our research project (no. 18–492). If the prescription support-tool improves the prescription of oral ATs, we will create an interactive web tool and will assess its impact in terms of clinical outcomes in real-life.Trial registration numberNCT03630874; Pre-results.

scholarly journals A National Quality Improvement Collaborative for the clinical use of outcome measurement in specialised mental healthcare: Results from a parallel group design and a nested cluster randomised controlled trial

BJPsych Open ◽  
2017 ◽  
Vol 3 (3) ◽  
pp. 106-112 ◽  
Author(s):  
Margot J. Metz ◽  
Marjolein A. Veerbeek ◽  
Gerdien C. Franx ◽  
Christina M. van der Feltz-Cornelis ◽  
Edwin de Beurs ◽  
...  
Keyword(s):  
Outcome Measurement ◽  
Controlled Trial ◽  
Mental Healthcare ◽  
Cluster Randomised Controlled Trial ◽  
Group Design ◽  
Cluster Randomised ◽  
Parallel Group Design ◽  
Parallel Group ◽  
National Quality ◽  
Randomised Controlled

BackgroundAlthough the importance and advantages of measurement-based care in mental healthcare are well established, implementation in daily practice is complex and far from optimal.AimsTo accelerate the implementation of outcome measurement in routine clinical practice, a government-sponsored National Quality Improvement Collaborative was initiated in Dutch-specialised mental healthcare.MethodTo investigate the effects of this initiative, we combined a matched-pair parallel group design (21 teams) with a cluster randomised controlled trial (RCT) (6 teams). At the beginning and end, the primary outcome ‘actual use and perceived clinical utility of outcome measurement’ was assessed.ResultsIn both designs, intervention teams demonstrated a significant higher level of implementation of outcome measurement than control teams. Overall effects were large (parallel group d=0.99; RCT d=1.25).ConclusionsThe National Collaborative successfully improved the use of outcome measurement in routine clinical practice.

Volunteers’ experiences of providing telephone-based breast-feeding peer support in the RUBY randomised controlled trial

2020 ◽  
Vol 23 (16) ◽  
pp. 3005-3015
Author(s):  
HA Grimes ◽  
T Shafiei ◽  
HL McLachlan ◽  
DA Forster
Keyword(s):  
Randomised Controlled Trial ◽  
Peer Support ◽  
Breast Feeding ◽  
Online Survey ◽  
Controlled Trial ◽  
Training Session ◽  
Public Hospitals ◽  
Support Intervention ◽  
Training Requirements ◽  
Randomised Controlled

AbstractObjective:The Ringing Up About Breastfeeding earlY (RUBY) randomised controlled trial (RCT) found that a telephone-based peer volunteer support intervention increased breast-feeding duration in a setting with high breast-feeding initiation. This sub-study of the RUBY RCT describes the motivation, preparation and experiences of volunteers who provided the peer support intervention.Design:An online survey was completed by 154 (67 %) volunteers after ceasing volunteering.Setting:Volunteers provided peer support to primiparous women (n 574) who birthed at one of three public hospitals in Melbourne, Australia, between February 2013 and December 2015.Participants:Volunteers (n 230) had themselves breastfed for at least 6 months and received 4 h of training for the role.Results:The median number of mothers supported was two (range 1–11), and two-thirds of respondents supported at least one mother for 6 months. Volunteers were motivated by a strong desire to support new mothers to establish and continue breast-feeding. Most (93 %) considered the training session adequate. The majority (60 %) reported following the call schedule ‘most of the time’, but many commented that ‘it depends on the mother’. Overall, 84 % of volunteers were satisfied with the role and reported that the experience was enjoyable (85 %) and worthwhile (90 %). Volunteers agreed that telephone support for breast-feeding was valued by women (88 %) and that the programme would be effective in helping women to breastfeed (93 %).Conclusions:These findings are important for those developing similar peer support programmes in which recruiting volunteers and developing training requirements are an integral and recurrent part of volunteer management.

scholarly journals Pain Measurement in Rheumatic and Musculoskeletal Diseases: Where To Go from Here? Report from a Special Interest Group at OMERACT 2018

2019 ◽  
Vol 46 (10) ◽  
pp. 1355-1359 ◽  
Author(s):  
Alessandro Chiarotto ◽  
Ulrike Kaiser ◽  
Ernest Choy ◽  
Robin Christensen ◽  
Philip G. Conaghan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Pain Measurement ◽  
Research Agenda ◽  
Online Survey ◽  
Musculoskeletal Diseases ◽  
Core Outcome ◽  
Core Outcome Sets ◽  
Pain Experience ◽  
Key Questions

Objective.Establishing a research agenda on standardizing pain measurement in clinical trials in rheumatic and musculoskeletal diseases (RMD).Methods.Discussion during a meeting at the Outcome Measures in Rheumatology (OMERACT) 2018, prepared by a systematic review of existing core outcome sets and a patient online survey.Results.Several key questions were debated: Is pain a symptom or a disease? Are pain core (sub)domains consistent across RMD? How to account for pain mechanistic descriptors (e.g., central sensitization) in pain measurement?Conclusion.Characterizing and assessing the spectrum of pain experience across RMD in a standardized fashion is the objective of the OMERACT Pain Working Group.

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