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Article ; Online: Core outcome sets in medical research.

Kirkham, Jamie J / Williamson, Paula

BMJ medicine

2022 Volume 1, Issue 1, Page(s) e000284

Language	English
Publishing date	2022-10-17
Publishing country	England
Document type	Journal Article
ISSN	2754-0413
ISSN (online)	2754-0413
DOI	10.1136/bmjmed-2022-000284
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Developing a core outcome set for hand fractures and joint injuries in adults.

Deshmukh, Sandeep R / Kirkham, Jamie J / Karantana, Alexia

Bone & joint open

2023 Volume 4, Issue 2, Page(s) 87–95

Abstract: The aim of this study was to develop a core outcome set of what to measure in all future clinical research on hand fractures and joint injuries in adults. Phase 1 consisted of steps to identify potential outcome domains through systematic review of ... ...

Abstract	The aim of this study was to develop a core outcome set of what to measure in all future clinical research on hand fractures and joint injuries in adults. Phase 1 consisted of steps to identify potential outcome domains through systematic review of published studies, and exploration of the patient perspective through qualitative research, consisting of 25 semi-structured interviews and five focus groups. Phase 2 involved key stakeholder groups (patients, hand surgeons, and hand therapists) prioritizing the outcome domains via a three-round international Delphi survey, with a final consensus meeting to agree the final core outcome set. The systematic review of 160 studies identified 74 outcome domains based on the World Health Organization International Classification of Functioning, Disability, and Health. Overall, 35 domains were generated through thematic analysis of the patient interviews and focus groups. The domains from these elements were synthesised to develop 37 outcome domains as the basis of the Delphi survey, with a further four generated from participant suggestions in Round 1. The Delphi survey identified 20 outcome domains as 'very important' for the core outcome set. At the consensus meeting, 27 participants from key stakeholder groups selected seven outcomes for the core outcome set: pain/discomfort with activity, pain/discomfort with rest, fine hand use/dexterity, self-hygiene/personal care, return to usual work/job, range of motion, and patient satisfaction with outcome/result. This set of core outcome domains is recommended as a minimum to be reported in all clinical research on hand fractures and joint injuries in adults. While this establishes what to measure, future work will focus on determining how best to measure these outcomes. By adopting this patient-centred core outcome set, consistency and comparability of studies will be improved, aiding meta-analysis and strengthening the evidence base for management of these common and impactful injuries.
Language	English
Publishing date	2023-02-10
Publishing country	England
Document type	Journal Article
ISSN	2633-1462
ISSN (online)	2633-1462
DOI	10.1302/2633-1462.42.BJO-2022-0105.R1
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Article ; Online: Development of core outcome sets and core outcome measures for central visual impairment, visual field loss and ocular motility disorders due to stroke: a Delphi and consensus study.

Rowe, Fiona J / Hepworth, Lauren R / Kirkham, Jamie J

BMJ open

2022 Volume 12, Issue 3, Page(s) e056792

Abstract: Objectives: Reporting of research for stroke-related visual impairment is inconsistent. The aim of this study was to define three core outcome sets (COS) and related core outcome measurements (COM) for central visual impairment, visual field loss and ... ...

Abstract	Objectives: Reporting of research for stroke-related visual impairment is inconsistent. The aim of this study was to define three core outcome sets (COS) and related core outcome measurements (COM) for central visual impairment, visual field loss and ocular motility disorders in stroke research. Design: The consensus process consisted of an online three-round Delphi survey followed by a consensus meeting of key stakeholders. Setting: UK-wide survey. Participants: Stakeholders included orthoptists, occupational therapists, ophthalmologists, stroke survivors and COS users such as researchers, journal editors and guideline developers. Outcome measures: For COS development, a list of potentially relevant visual outcomes was created after review of the literature and further grouped into outcome domains. For COM development, a list of potential instruments was created after review of the literature and quality appraised for reliability and validity. Results: COS-119 potential outcomes extracted from published literature. Similar assessment outcomes were grouped into 24 outcome domains. Delphi process included 123 participants in round 1, 65 round 2, 51 round 3. Twelve participants attended the consensus meeting with recommended outcome domains for central visual impairment (visual acuity, functional vision, quality of life), visual field loss (visual fields, functional vision, quality of life) and ocular motility disorders (eye alignment, eye movements, functional vision, quality of life). COM-52 test options extracted from the COS outcomes and grouped into 16 domains. Thirteen participants attended the COM consensus meeting. Recommended instruments for measurement of these outcomes include; Logarithm of the Minimal Angle of Resolution visual acuity, cover test, cardinal position eye movement assessments, peripheral visual field perimetry, Visual Function Questionnaire-25. Conclusions: COS and COM are defined for vision research for stroke survivors. Their use has potential to reduce heterogeneity in routine clinical practice and improve standardisation and accuracy of vision assessment. Future research is required to evaluate the use of these COS and COM.
MeSH term(s)	Delphi Technique ; Humans ; Ocular Motility Disorders ; Outcome Assessment, Health Care ; Quality of Life ; Reproducibility of Results ; Research Design ; Stroke/complications ; Treatment Outcome ; Vision Disorders/etiology ; Visual Field Tests
Language	English
Publishing date	2022-03-18
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2021-056792
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Article ; Online: Interventions for improving the design and conduct of scientific research: A scoping review protocol.

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

NIHR open research

2022 Volume 2, Page(s) 4

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.
Language	English
Publishing date	2022-06-14
Publishing country	England
Document type	Journal Article
ISSN	2633-4402
ISSN (online)	2633-4402
DOI	10.3310/nihropenres.13252.2
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Article ; Online: Core outcome set for three ophthalmic conditions: a healthcare professional and patient consensus on core outcome sets for amblyopia, ocular motility and strabismus (COSAMS Study).

Al-Jabri, Samiya / Rowe, Fiona J / Kirkham, Jamie J

BMJ open

2021 Volume 11, Issue 5, Page(s) e042403

Abstract: Objectives: Amblyopia, strabismus and ocular motility disorders are common conditions with significant impact on visual function, appearance and quality of life. We aimed to establish a core set of outcomes for each of the three conditions for use in ... ...

Abstract	Objectives: Amblyopia, strabismus and ocular motility disorders are common conditions with significant impact on visual function, appearance and quality of life. We aimed to establish a core set of outcomes for each of the three conditions for use in clinical trials and routine clinical practice. Design: A comprehensive databank of outcomes was developed from a systematic review of the literature and a series of focus groups with healthcare professionals, researchers, patients and carers. The databank of outcomes was scored in a two-round Delphi Survey completed by two stakeholder groups: healthcare professionals/researchers and patients/carers. Results of the online Delphi were discussed at a face-to-face consensus meeting where the core outcome sets were finalised. Setting: UK-wide consultation. Participants: Researchers, clinicians, patients and carers. Outcome measures: Core outcome sets. Results: For amblyopia, strabismus and ocular motility, 40/42/33 participants contributed to both rounds of the Delphi; six/nine/seven members attended consensus meetings, respectively. Consensus was reached on ten core outcomes for both amblyopia and ocular motility and nine for strabismus. All three conditions shared the core outcomes: Conclusions: The study used robust consensus methods to develop a core outcome set for three ophthalmic conditions. Implementation of these core outcome sets in clinical trials and routine clinical practice will ensure that the outcomes being measured and reported are relevant to all stakeholders. This will enhance the relevance of study findings and enable comparison of results from different studies.
MeSH term(s)	Amblyopia/therapy ; Consensus ; Delphi Technique ; Humans ; Outcome Assessment, Health Care ; Quality of Life ; Research Design ; Strabismus/therapy ; Systematic Reviews as Topic ; Treatment Outcome
Language	English
Publishing date	2021-05-11
Publishing country	England
Document type	Dataset ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2020-042403
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Article ; Online: Association between hearing loss and deprivation among Welsh adults: a cross-sectional observational study.

Allum, Jack / Meredith, Rhys / Uus, Kai / Kirkham, Jamie J / Dawes, Piers

BMJ open

2023 Volume 13, Issue 5, Page(s) e066419

Abstract: Objective: To index levels of hearing loss with respect to area-level indices of deprivation in a Welsh population.: Design: A cross-sectional observational study of all adults (aged >18) that attended Abertawe Bro Morgannwg University (ABMU) Health ... ...

Abstract	Objective: To index levels of hearing loss with respect to area-level indices of deprivation in a Welsh population. Design: A cross-sectional observational study of all adults (aged >18) that attended Abertawe Bro Morgannwg University (ABMU) Health Board audiology services between 2016 and 2018. Service access, first hearing aid fitting appointment rates and hearing loss at time of first hearing aid provision were used to index population hearing loss versus area-level indices of deprivation based on patient postcode. Setting: Primary and secondary care. Participants: 59 493 patient entries met the inclusion criteria. Patient entries were grouped by age (18-30, 31-40, 41-50, 51-60, 61-70, 71-80, >80 years) and deprivation decile. Results: The interaction between age group and deprivation decile predicted access rate to ABMU audiology services (b=-0.24, t(6858) = -2.86, p<0.01) with audiology services accessed more frequently by the most deprived versus the least deprived decile in every age group (p<0.05), except the >80 years. First hearing aid fitting rates were highest among the most deprived in the four youngest age groups (p<0.05). Severity of hearing loss at the time of first hearing aid fitting was worse among the most deprived in the five oldest age groups (p<0.01). Conclusions: Hearing health inequalities are prevalent among adults accessing ABMU audiology services. Our findings suggest that deprivation increases the likelihood of developing hearing loss, brings earlier onset of hearing loss and is linked to delays in getting help for hearing problems. However, it is not possible to know the true scale of these disparities without knowing the hearing health of the Welsh adult population including those who do not seek help for hearing problems.
MeSH term(s)	Adult ; Humans ; Cross-Sectional Studies ; Hearing Loss/epidemiology ; Deafness ; Hearing Aids ; Hearing
Language	English
Publishing date	2023-05-05
Publishing country	England
Document type	Observational Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2022-066419
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Article ; Online: Gynecological trials frequently exclude people based on their symptoms rather than their condition: a systematic review of Cochrane reviews and their component trials.

Stocking, Katie / Watson, Andrew / Kirkham, Jamie J / Wilkinson, Jack / Vail, Andy

Journal of clinical epidemiology

2023 Volume 163, Page(s) 29–36

Abstract: Objectives: To identify strategies used in recent randomized controlled trials (RCTs) and their associated Cochrane Reviews where patients with the same gynecological condition present with different symptoms but would plausibly benefit from a common ... ...

Abstract	Objectives: To identify strategies used in recent randomized controlled trials (RCTs) and their associated Cochrane Reviews where patients with the same gynecological condition present with different symptoms but would plausibly benefit from a common intervention. Study design and setting: We searched the Cochrane library (February 2022) for reviews in polycystic ovarian syndrome (PCOS) and endometriosis. Reviews were included if the intervention was intended to treat all condition-specific symptoms. For each trial we recorded the strategy used and the number of potentially eligible participants excluded as a direct result of the chosen strategy. For each review we recorded the numbers of RCTs and participants excluded on the basis of symptoms experienced. Results: There were 89 distinct PCOS trials in 13 reviews, and 13 Endometriosis trials in 11 reviews. Most trials restricted their eligibility to participants with specific symptoms (55% PCOS, 46% endometriosis). The second most common strategy was to measure and analyze clinical outcomes that were not relevant to all participants (38% PCOS, 31% endometriosis). Reviews excluded 27% of trials in participants evaluating the same intervention in participants experiencing the same condition based on the outcomes measured in the trials. Conclusion: Most gynecological trials exclude patients who could benefit from treatment or measure outcomes not relevant to all participants. We introduce a taxonomy to describe trial design strategies for conditions with heterogeneous symptoms.
MeSH term(s)	Female ; Humans ; Endometriosis/therapy ; Gynecology ; Outcome Assessment, Health Care
Language	English
Publishing date	2023-09-29
Publishing country	United States
Document type	Systematic Review ; Journal Article
ZDB-ID	639306-8
ISSN	1878-5921 ; 0895-4356
ISSN (online)	1878-5921
ISSN	0895-4356
DOI	10.1016/j.jclinepi.2023.09.012
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Assessment highlights need for improvement in standards of development of core outcome sets for rare genetic diseases.

Ciucă, Andrada / Banka, Siddharth / Newman, William G / Moldovan, Ramona / Kirkham, Jamie J

Journal of clinical epidemiology

2023 Volume 161, Page(s) 84–93

Abstract: Objectives: A rare disease is classified as such if it affects less than one person in 2,000. The Core Outcome Set STandards for Development (COS-STAD) is a set of standards that represent the minimum recommendations to be considered in the process of ... ...

Abstract	Objectives: A rare disease is classified as such if it affects less than one person in 2,000. The Core Outcome Set STandards for Development (COS-STAD) is a set of standards that represent the minimum recommendations to be considered in the process of core outcome set (COS) development. The aim of this study was to provide a baseline assessment of COS development standards for rare genetic diseases. Study design and setting: Core Outcome Measures in Effectiveness Trials (COMET) database contains nearly 400 published COS studies according to the latest systematic review. Studies focusing on COS development for rare genetic diseases were eligible for inclusion and were assessed by two independent evaluators. Results: Nine COS studies were included in the analysis. Eight different rare genetic diseases were investigated. None of the studies met all the standards for development. The number of standards met ranged from 6 to 10, and the median was 7. Conclusion: This study is the first study to assess COS-STAD for rare genetic diseases, and it highlights a great need for improvement. First in terms of numbers of rare diseases considered for COS developments, second in methodology, particularly regarding the consensus process, and third in reporting of the COS development studies.
MeSH term(s)	Humans ; Delphi Technique ; Endpoint Determination/methods ; Outcome Assessment, Health Care/methods ; Rare Diseases/genetics ; Rare Diseases/therapy ; Research Design ; Treatment Outcome
Language	English
Publishing date	2023-07-07
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	639306-8
ISSN	1878-5921 ; 0895-4356
ISSN (online)	1878-5921
ISSN	0895-4356
DOI	10.1016/j.jclinepi.2023.07.002
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Article ; Online: Study found increasing use of core outcome sets in Cochrane systematic reviews and identified facilitators and barriers.

Saldanha, Ian J / Hughes, Karen L / Dodd, Susanna / Lasserson, Toby / Kirkham, Jamie J / Wu, Yuhui / Lucas, Samuel W / Williamson, Paula R

Journal of clinical epidemiology

2024 Volume 169, Page(s) 111277

Abstract: Objectives: In 2019, only 7% of Cochrane systematic reviews (SRs) cited a core outcome set (COS) in relation to choosing outcomes, even though a relevant COS existed but was not mentioned (or cited) for a further 29% of SRs. Our objectives for the ... ...

Abstract	Objectives: In 2019, only 7% of Cochrane systematic reviews (SRs) cited a core outcome set (COS) in relation to choosing outcomes, even though a relevant COS existed but was not mentioned (or cited) for a further 29% of SRs. Our objectives for the current work were to (1) examine the extent to which authors are currently considering COS to inform outcome choice in Cochrane protocols and completed SRs, and (2) understand author facilitators and barriers to using COS. Study design and setting: We examined all completed Cochrane SRs published in the last 3 months of 2022 and all Cochrane protocols published in 2022 for the extent to which they: (a) cited a COS, (b) searched for COS, (c) used outcomes from existing COS, and (d) reported outcome inconsistency among included studies and/or noted the need for COS. One investigator extracted information; a second extractor verified all information, discussing discrepancies to achieve consensus. We then conducted an online survey of authors of the included SRs to assess awareness of COS and identify facilitators and barriers to using COS to inform outcome choice. Results: Objective 1: We included 294 SRs of interventions (84 completed SRs and 210 published SR protocols), of which 13% cited specific COS and 5% did not cite but mentioned searching for COS. A median of 83% of core outcomes from cited COS (interquartile range [IQR] 57%-100%) were included in the corresponding SR. We identified a relevant COS for 39% of SRs that did not cite a COS. A median of 50% of core outcomes from noncited COS (IQR 35%-72%) were included in the corresponding SR. Objective 2: Authors of 236 (80%) of the 294 eligible SRs completed our survey. Seventy-seven percent of authors noted being aware of COS before the survey. Fifty-five percent of authors who did not cite COS but were aware of them reported searching for a COS. The most reported facilitators of using COS were author awareness of the existence of COS (59%), author positive perceptions of COS (52%), and recommendation in the Cochrane Handbook regarding COS use (48%). The most reported barriers related to matching of the scope of the COS and the SR: the COS target population was too narrow/broad relative to the SR population (29%) or the COS target intervention was too narrow/broad relative to the SR intervention (21%). Most authors (87%) mentioned that they would consider incorporating missing core outcomes in the SR/update. Conclusion: Since 2019, there is increasing consideration and awareness of COS when choosing outcomes for Cochrane SRs of interventions, but uptake remains low and can be improved further. Use of COS in SRs is important to improve outcome standardization, reduce research waste, and improve evidence syntheses of the relevant effects of interventions across health research.
Language	English
Publishing date	2024-02-29
Publishing country	United States
Document type	Journal Article
ZDB-ID	639306-8
ISSN	1878-5921 ; 0895-4356
ISSN (online)	1878-5921
ISSN	0895-4356
DOI	10.1016/j.jclinepi.2024.111277
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Article ; Online: Evaluation of editors' abilities to predict the citation potential of research manuscripts submitted to

Schroter, Sara / Weber, Wim E J / Loder, Elizabeth / Wilkinson, Jack / Kirkham, Jamie J

BMJ (Clinical research ed.)

2022 Volume 379, Page(s) e073880

Abstract: Objective: To evaluate the ability of : Design: Cohort study.: Setting: Manuscripts submitted to : Participants: 10 : Main outcome measures: Reviewed manuscripts were rated independently by attending editors for citation potential in the ... ...

Abstract	Objective: To evaluate the ability of Design: Cohort study. Setting: Manuscripts submitted to Participants: 10 Main outcome measures: Reviewed manuscripts were rated independently by attending editors for citation potential in the year of first publication plus the next year: no citations, below average (<10 citations), average (10-17 citations), or high (>17 citations). Predicted citations were subsequently compared with actual citations extracted from Web of Science (WOS). Results: Of 534 manuscripts reviewed, 505 were published as full length articles (219 in Conclusions: Editors weren't good at estimating the citation potential of manuscripts individually or as a group; there is no wisdom of the crowd when it comes to
MeSH term(s)	Humans ; Cohort Studies
Language	English
Publishing date	2022-12-14
Publishing country	England
Document type	Journal Article
ZDB-ID	1362901-3
ISSN	1756-1833 ; 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
ISSN (online)	1756-1833
ISSN	0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
DOI	10.1136/bmj-2022-073880
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