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  1. Article ; Online: Interventions for improving the design and conduct of scientific research

    Catriona McDaid / Andrew Mott / Catherine Hewitt / Jamie J Kirkham

    NIHR Open Research, Vol

    A scoping review protocol [version 2; peer review: 2 approved]

    2022  Volume 2

    Abstract: Background Research waste is prevalent in many scientific fields despite a number of initiatives to improve research practices. Interventions to improve practice are often implemented without evaluating their effectiveness. It is therefore important to ... ...

    Abstract Background Research waste is prevalent in many scientific fields despite a number of initiatives to improve research practices. Interventions to improve practice are often implemented without evaluating their effectiveness. It is therefore important to identify the interventions that have been evaluated, assess how they have been evaluated and to identify areas where further research is required. Objectives A scoping review will be undertaken to assess what interventions, aimed at researchers or research teams, to improve research design and conduct have been evaluated. This review will also consider when in the research pathway these interventions are implemented; what aspects of research design or conduct are being targeted; and who is implementing these interventions. Methods Interventions which aim to improve the design or conduct of research will be eligible for inclusion. The review will not include interventions aimed at hypothetical research projects or interventions implemented without evaluation. The following sources will be searched: MEDLINE, EMBASE, ERIC, HMIC, EconLit, Social Policy and Practice, ProQuest theses, and MetaArXiv. Hand searching of references and citations of included studies will also be undertaken. Searches will be limited to articles published in the last 10 years. Data extraction will be completed using a data extraction template developed for this review. Results will be tabulated by type of intervention, research stage, and outcome. A narrative review will also be provided addressing each of the objectives.
    Keywords Meta-Research ; Research-on-Research ; Research Design ; Research Conduct ; Research Waste ; Scoping Review ; eng ; Medicine ; R
    Subject code 306
    Language English
    Publishing date 2022-06-01T00:00:00Z
    Publisher F1000 Research Ltd
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: Reverse shoulder arthroplasty versus hemiarthroplasty versus non-surgical treatment for older adults with acute 3- or 4-part fractures of the proximal humerus

    Amar Rangan / Stephen Gwilym / Ada Keding / Belen Corbacho / Lucksy Kottam / Catherine Arundel / Elizabeth Coleman / Livio DiMascio / Catherine Hewitt / Valerie Jones / Jamila Kassam / Catriona McDaid / Natasha Mitchell / Andrew Mott / Grace O’Carroll / Puvan Tharmanathan / David Torgerson

    Trials, Vol 24, Iss 1, Pp 1-

    study protocol for a randomised controlled trial (PROFHER-2: PROximal Fracture of Humerus Evaluation by Randomisation – Trial Number 2)

    2023  Volume 14

    Abstract: Abstract Background Proximal humerus fractures (PHF) are common and painful injuries, with the majority resulting from falls from a standing height. As with other fragility fractures, its age-specific incidence is increasing. Surgical treatment with ... ...

    Abstract Abstract Background Proximal humerus fractures (PHF) are common and painful injuries, with the majority resulting from falls from a standing height. As with other fragility fractures, its age-specific incidence is increasing. Surgical treatment with hemiarthroplasty (HA) and reverse shoulder arthroplasty (RSA) have been increasingly used for displaced 3- and 4-part fractures despite a lack of good quality evidence as to whether one type of arthroplasty is superior to the other, and whether surgery is better than non-surgical management. The PROFHER-2 trial has been designed as a pragmatic, multicentre randomised trial to compare the clinical and cost-effectiveness of RSA vs HA vs Non-Surgical (NS) treatment in patients with 3- and 4-part PHF. Methods Adults over 65 years of age presenting with acute radiographically confirmed 3- or 4-part fractures, with or without associated glenohumeral joint dislocation, who consent for trial participation will be recruited from around 40 National Health Service (NHS) Hospitals in the UK. Patients with polytrauma, open fractures, presence of axillary nerve palsy, pathological (other than osteoporotic) fractures, and those who are unable to adhere to trial procedures will be excluded. We will aim to recruit 380 participants (152 RSA, 152 HA, 76 NS) using 2:2:1 (HA:RSA:NS) randomisation for 3- or 4-part fractures without joint dislocation, and 1:1 (HA:RSA) randomisation for 3- or 4-part fracture dislocations. The primary outcome is the Oxford Shoulder Score at 24 months. Secondary outcomes include quality of life (EQ-5D-5L), pain, range of shoulder motion, fracture healing and implant position on X-rays, further procedures, and complications. Independent Trial Steering Committee and Data Monitoring Committee will oversee the trial conduct, including the reporting of adverse events and harms. Discussion The PROFHER-2 trial is designed to provide a robust answer to guide the treatment of patients aged 65 years or over who sustain 3- and 4-part proximal humeral fractures. The ...
    Keywords Proximal humeral fracture ; Reverse shoulder arthroplasty ; Hemiarthroplasty ; Non-surgical treatment ; Randomised trial ; Medicine (General) ; R5-920
    Subject code 410
    Language English
    Publishing date 2023-04-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: An assessment of the extent to which the contents of PROSPERO records meet the systematic review protocol reporting items in PRISMA-P [version 1; peer review

    Alison Booth / Alex S. Mitchell / Andrew Mott / Sophie James / Sarah Cockayne / Samantha Gascoyne / Catriona McDaid

    F1000Research, Vol

    2 approved]

    2020  Volume 9

    Abstract: Background: PROSPERO is an international prospective register for systematic review protocols. Many of the registrations are the only available source of information about planned methods. This study investigated the extent to which records in PROSPERO ... ...

    Abstract Background: PROSPERO is an international prospective register for systematic review protocols. Many of the registrations are the only available source of information about planned methods. This study investigated the extent to which records in PROSPERO contained the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). Methods: A random sample of 439 single entry PROSPERO records of reviews of health interventions registered in 2018 was identified. Using a piloted list of 19 PRISMA-P items, divided into 63 elements, two researchers independently assessed the registration records. Where the information was present or not applicable to the review, a score of 1 was assigned. Overall scores were calculated and comparisons made by stage of review at registration, whether or not a meta-analysis was planned and whether or not funding/sponsorship was reported. Results: Some key methodological details, such as eligibility criteria, were relatively frequently reported, but much of the information recommended in PRISMA-P was not stated in PROSPERO registrations. Considering the 19 items, the mean score was 4.8 (SD 1.8; median 4; range 2-11) and across all the assessed records only 25% (2081/8227) of the items were scored as reported. Considering the 63 elements, the mean score was 33.4 (SD 5.8; median 33; range 18-47) and overall, 53% (14,469/27,279) of the elements were assessed as reported. Reporting was more frequent for items required in PROSPERO than optional items. The planned comparisons showed no meaningful differences between groups. Conclusions: PROSPERO provides reviewers with the opportunity to be transparent in their planned methods and demonstrate efforts to reduce bias. However, where the PROSPERO record is the only available source of a priori reporting, there is a significant shortfall in the items reported, compared to those recommended. This presents challenges in interpretation for those wishing to assess the validity of the final review.
    Keywords Medicine ; R ; Science ; Q
    Subject code 333
    Language English
    Publishing date 2020-07-01T00:00:00Z
    Publisher F1000 Research Ltd
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: An assessment of the extent to which the contents of PROSPERO records meet the systematic review protocol reporting items in PRISMA-P [version 2; peer review

    Alison Booth / Alex S. Mitchell / Andrew Mott / Sophie James / Sarah Cockayne / Samantha Gascoyne / Catriona McDaid

    F1000Research, Vol

    2 approved]

    2020  Volume 9

    Abstract: Background: PROSPERO is an international prospective register for systematic review protocols. Many of the registrations are the only available source of information about planned methods. This study investigated the extent to which records in PROSPERO ... ...

    Abstract Background: PROSPERO is an international prospective register for systematic review protocols. Many of the registrations are the only available source of information about planned methods. This study investigated the extent to which records in PROSPERO contained the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). Methods: A random sample of 439 single entry PROSPERO records of reviews of health interventions registered in 2018 was identified. Using a piloted list of 19 PRISMA-P items, divided into 63 elements, two researchers independently assessed the registration records. Where the information was present or not applicable to the review, a score of 1 was assigned. Overall scores were calculated and comparisons made by stage of review at registration, whether or not a meta-analysis was planned and whether or not funding/sponsorship was reported. Results: Some key methodological details, such as eligibility criteria, were relatively frequently reported, but much of the information recommended in PRISMA-P was not stated in PROSPERO registrations. Considering the 19 items, the mean score was 4.8 (SD 1.8; median 4; range 2-11) and across all the assessed records only 25% (2081/8227) of the items were scored as reported. Considering the 63 elements, the mean score was 33.4 (SD 5.8; median 33; range 18-47) and overall, 53% (14,469/27,279) of the elements were assessed as reported. Reporting was more frequent for items required in PROSPERO than optional items. The planned comparisons showed no meaningful differences between groups. Conclusions: PROSPERO provides reviewers with the opportunity to be transparent in their planned methods and demonstrate efforts to reduce bias. However, where the PROSPERO record is the only available source of a priori reporting, there is a significant shortfall in the items reported, compared to those recommended. This presents challenges in interpretation for those wishing to assess the validity of the final review.
    Keywords Medicine ; R ; Science ; Q
    Subject code 333
    Language English
    Publishing date 2020-09-01T00:00:00Z
    Publisher F1000 Research Ltd
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: Negative pressure wound therapy versus usual care for surgical wounds healing by secondary intention (SWHSI-2 trial)

    Ian Chetter / Catherine Arundel / Belen Corbacho Martin / Catherine Hewitt / Caroline Fairhurst / Kalpita Joshi / Andrew Mott / Sara Rodgers / Pedro Saramago Goncalves / David Torgerson / Jacqueline Wilkinson / Jane Blazeby / Rhiannon Macefield / Stephen Dixon / Eileen Henderson / Angela Oswald / Jo Dumville / Matthew Lee / Thomas Pinkney /
    Nikki Stubbs / Lyn Wilson

    Trials, Vol 22, Iss 1, Pp 1-

    study protocol for a pragmatic, multicentre, cross surgical specialty, randomised controlled trial

    2021  Volume 14

    Abstract: Abstract Background The majority of surgical wounds are closed (for example with sutures or staples) and so heal by primary intention. Where closure is not possible, or the wound subsequently breaks down, wounds may be left to heal from the bottom up ( ... ...

    Abstract Abstract Background The majority of surgical wounds are closed (for example with sutures or staples) and so heal by primary intention. Where closure is not possible, or the wound subsequently breaks down, wounds may be left to heal from the bottom up (healing by secondary intention). Surgical wound healing by secondary intention (SWHSI) frequently presents a significant management challenge. Additional treatments are often required during the course of healing, and thus a significant financial burden is associated with treating these wounds. Increasingly, negative pressure wound therapy (NPWT) is used in the management of SWHSI. This wound dressing system provides a negative pressure (vacuum) to the wound, removing fluid into a canister, which is believed to be conducive to wound healing. Despite the increasing use of NPWT, there is limited robust evidence for the effectiveness of this device. A well-designed and conducted randomised controlled trial is now required to ascertain if NPWT is a clinically and cost-effective treatment for SWHSI. Methods SWHSI-2 is a pragmatic, multi-centre, cross surgical specialty, two arm, parallel group, randomised controlled superiority trial. Adult patients with a SWHSI will be randomised to receive either NPWT or usual care (no NPWT) and will be followed up for 12 months. The primary outcome will be time to healing (defined as full epithelial cover in absence of a scab) in number of days since randomisation. Secondary outcomes will include key clinical events (hospital admission or discharge, treatment status, reoperation, amputation, antibiotic use and death), wound infection, wound pain, health-related quality of life, health utility and resource use. Discussion Given the increasing use of NPWT, despite limited high-quality supporting evidence, the SWHSI-2 Trial will provide robust evidence on the clinical and cost-effectiveness of NPWT in the management of SWHSI. The SWHSI-2 Trial opened to recruitment in May 2019 and is currently recruiting across 20 participating centres. ...
    Keywords Surgical wounds ; Negative pressure wound therapy ; Secondary intention ; Wound healing ; Randomised controlled trial ; Medicine (General) ; R5-920
    Language English
    Publishing date 2021-10-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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