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"Knapp, Peter"
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Why do patients take part in research? An overview of systematic reviews of psychosocial barriers and facilitators
2020
Background
Understanding why people take part in health research is critical to improve research efficiency and generalisability. The aim of this overview of systematic reviews was to identify psychosocial determinants of research participation and map them to psychological theory and empirical recruitment research, to identify effective strategies to increase research participation.
Methods
Qualitative and quantitative systematic reviews were systematically identified. No date or language limits were applied. Two reviewers independently selected reviews. Methodological quality was rated using AMSTAR, and poor-quality reviews (scoring 0–3) were excluded. Barriers and facilitators were coded to psychological theory (Theoretical Domains Framework) and empirical recruitment research (recruitment interventions that had been subjected to randomised controlled trial evaluation).
Results
We included 26 systematic reviews (429 unique primary studies), covering a wide range of patient populations and health settings. We identified five groups of facilitators, of which three were dominant (potential for personal benefit, altruism, trust) and appear to be relevant across research setting and design. We identified nine groups of barriers, which were more dependent on the particular study (context, population, design). Two determinants (participant information, social influences) were found to be both barriers and facilitators. Barriers and facilitators could be coded to the Motivation and Opportunity components of the Theoretical Domains Framework; only one was coded to a Capability component. There was some overlap between psychosocial determinants and empirical recruitment research, but some barriers and facilitators had not been tested at all.
Conclusions
Identifying effective recruitment strategies could increase the efficiency and generalisability of primary research. We identified a number of barriers and facilitators that could be addressed by researchers. There is a need for more research to identify effective recruitment strategies that draw on the psychosocial facilitators and barriers identified in this overview.
Journal Article
The effectiveness of video animations as information tools for patients and the general public: A systematic review
by
Benhebil, Nadia
,
Moe-Byrne, Thirimon
,
Evans, Ella
in
Animation
,
Attitudes
,
attitudes and cognition
2022
Video animations are used increasingly as patient information tools; however, we do not know their value compared to other formats of delivery, such as printed materials, verbal consultations or static images.
This review compares the effectiveness of video animations as information tools vs. other formats of delivery on patient knowledge, attitudes and cognitions, and behaviours. Included studies had the following features: controlled design with random or quasi-random allocation; patients being informed about any health condition or members of the public being informed about a public health topic; comparing video animation with another delivery format. Multiple digital databases were searched from 1996-June 2021. We also undertook citation searching. We used dual, independent decision-making for inclusion assessment, data extraction and quality appraisal. Included studies were appraised using the Cochrane ROB2 tool. Findings were reported using narrative synthesis.
We included 38 trials, focussed on: explaining medical or surgical procedures (
= 17); management of long-term conditions (
= 11); public health, health-promotion or illness-prevention (
= 10). Studies evaluated cartoon animations (
= 29), 3D animations (
= 6), or 2D animations, \"white-board\" animations or avatars (
= 1 each). Knowledge was assessed in 30 studies, showing greater knowledge from animations in 19 studies, compared to a range of comparators. Attitudes and cognitions were assessed in 21 studies, and animations resulted in positive outcomes in six studies, null effects in 14 studies, and less positive outcomes than standard care in one study. Patient behaviours were assessed in nine studies, with animations resulting in positive outcomes in four and null effects in the remainder. Overall risk of bias was \"high\" (
= 18), \"some concerns\" (
= 16) or \"low\" (
= 4). Common reasons for increased risk of bias were randomisation processes, small sample size or lack of sample size calculation, missing outcome data, and lack of protocol publication.
The overall evidence base is highly variable, with mostly small trials. Video animations show promise as patient information tools, particularly for effects on knowledge, but further evaluation is needed in higher quality studies.
https://www.crd.york.ac.uk/prospero/display_record.php?, identifier: CRD42021236296.
Journal Article
The effectiveness of video animations in the education of healthcare practitioners and student practitioners: a systematic review of trials
2022
Introduction
Video animations are increasingly available in education but without systematic evaluation. This review aimed to collate trials of animations versus other delivery, in student or qualified healthcare practitioners.
Methods
Included studies had the following features: controlled design with random or quasi-random allocation; student or qualified healthcare practitioners; comparing video animation with another format (e.g. textbook, lecture, static images); animation delivered instead of, or in addition to, another format. The primary outcome was knowledge; secondary outcomes were attitudes and cognitions, and behaviours. Multiple databases were searched from 1996-October 2022 using a defined strategy. We also undertook citation searching. Dual, independent decision-making was used for inclusion assessment, data extraction, and quality appraisal. Included studies were appraised using the Cochrane ROB2 tool. Findings were reported using narrative synthesis.
Results
We included 13 studies: 11 recruited student practitioners, two recruited qualified practitioners, total
n
= 1068. Studies evaluated cartoon animations or 2D/3D animations. Knowledge was assessed in ten studies, showing greater knowledge from animations in eight studies. Attitudes and cognitions were assessed in five studies; animations resulted in positive outcomes in three studies, no difference in one study, and worse outcomes in one study. Behaviours were assessed in three studies, animations producing positive outcomes in two studies and there was no difference in one study. Overall risk of bias was ‘high’ in ten studies and ‘some concerns’ in three.
Discussion
Overall the evidence base is small with mostly ‘high’ risk of bias. Video animations show promise in practitioner education, particularly for effects on knowledge, but bigger, better research is needed.
Journal Article
Why do patients take part in research? An updated overview of systematic reviews of psychosocial barriers and facilitators
2025
Background
Efficient, equitable health research depends on understanding why people decide to take part. The aims of this overview were to update the version published in 2020, identifying psychosocial influences on participation and mapping them to recruitment research and psychological theory.
Methods
Searches were undertaken in February 2024. Qualitative, quantitative, and mixed-methods systematic reviews were identified, without language or date limits. Methodological quality was rated using AMSTAR-2, and low-quality reviews were excluded. Barriers and facilitators were identified inductively and mapped to the Theoretical Domains Framework (TDF) and COM-B model, and to empirical recruitment research.
Results
The update included 70 reviews, including 44 new reviews, covering a breadth of populations and settings, and drawing on 1940 primary studies (1428 unique).
We identified 15 facilitators, most commonly: altruism, potential for personal benefit and trust. Incentives and convenient, low-burden research were also facilitators. Another 10 facilitators were new to this update.
There were 16 barriers, most commonly: perceived risk, practical difficulties, and distrust of researchers. Many barriers applied to specific designs, particularly randomised trials. Factors that were barriers or facilitators include the influence of others and information quality.
Barriers and facilitators were coded to the Motivation and Opportunity components of the TDF, particularly knowledge and social influences; only two factors were coded to a Capability. Psychosocial influences and empirical recruitment research had some overlap, but some barriers and facilitators had not been evaluated.
Conclusions
Common barriers and facilitators to research participation were identified, some new to this update, which could be addressed through targeted recruitment strategies to increase the efficiency and generalisability of primary research. Factors affecting participation are not only personal; they are also normative and social. The priorities are to change the ways we recruit to research (perhaps tested in SWATs) and identify barriers and facilitators in areas not well covered in current research.
Trial registration
PROSPERO CRD42017062738. Registered on April 2017.
Journal Article
What, how, when and who of trial results summaries for trial participants: stakeholder-informed guidance from the RECAP project
by
Gillies, Katie
,
Tizzard, Juliet
,
Campbell, Marion
in
Clinical trials
,
Content analysis
,
Focus groups
2022
ObjectiveTo generate stakeholder informed evidence to support recommendations for trialists to implement the dissemination of results summaries to participants.DesignA multiphase mixed-methods triangulation design involving Q-methodology, content analysis, focus groups and a coproduction workshop (the REporting Clinical trial results Appropriately to Participants project).SettingPhase III effectiveness trials.ParticipantsA range of participants were included from ongoing and recently completed trials, public contributors, trialists, sponsors, research funders, regulators, ethics committee members.ResultsFewer than half of the existing trial result summaries contained information on the clinical implications of the study results, an item deemed to be of high importance to participants in the Q-methodology study. Priority of inclusion of a thank you message varied depending on whether considering results for individuals or populations. The need for personally responsive modes of sharing trial result summaries was highlighted as important. Ideally, participants should be the first to know of the results with regard to the timing of sharing results summaries but given this can be challenging it is therefore important to manage expectations. In addition to patients, it was identified that it is important to engage with a range of stakeholders when developing trial results summaries.ConclusionsResults summaries for trial participants should cover four core questions: (1) What question the trial set out to answer?; (2) What did the trial find?; (3) What effect have the trial results had and how will they change National Health Service/treatment?; and (4) How can I find out more? Trial teams should develop appropriately resourced plans and consult patient partners and trial participants on how ‘best’ to share key messages with regard to content, mode, and timing. The study findings provide trial teams with clear guidance on the core considerations of the ‘what, how, when and who’ with regard to sharing results summaries.
Journal Article
Buyer beware? Does the information provided with herbal products available over the counter enable safe use?
by
Long, Andrew F
,
Nicolson, Donald J
,
Raynor, David K
in
Analysis
,
Biomedicine
,
Dosage and administration
2011
Background
Herbal products obtained over the counter are commonly used in Europe, North America and Australia. Although there is concern about a lack of information provided to consumers to allow the safe use of these products, there has been no published research to confirm these fears. In this study, we evaluated written information provided with commonly used herbal products in the UK in advance of a European Union Directive issued in April 2011 that tightened regulations for some herbal products, including requirements to provide safety information.
Methods
Five commonly used herbal products were purchased from pharmacies, health food shops and supermarkets: St John's wort, Asian ginseng, echinacea, garlic and ginkgo. Written information provided with the products (on the package or on a leaflet contained in the package) was evaluated for inclusion of each of the key safety messages included in the monographs of the US National Center for Complementary and Alternative Medicine. Specifically, we looked for information on precautions (such as Asian ginseng not being suitable for people with diabetes), interactions with conventional medicines (such as St John's wort with the contraceptive pill and warfarin) and side effects (such as ginkgo and allergic reactions).
Results
Our analysis showed that, overall, 51 (75%) of 68 products contained none of the key safety messages. This included 4 of 12 St John's wort products, 12 of 12 ginkgo products, 6 of 7 Asian ginseng products, 20 of 21 garlic products and 9 of 13 echinacea products. The two products purchased that are registered under the new European Union regulations (for St John's wort) contained at least 85% of the safety messages.
Conclusions
Most of the herbal medicine products studied did not provide key safety information which consumers need for their safe use. The new European Union legislation should ensure that St John's wort and echinacea products will include the previously missing information in due course. The legislation does not apply to existing stock. Depending on therapeutic claims made by manufacturers, garlic, ginkgo and Asian ginseng products may not be covered by the legislation and can continue to be bought without the safety information. Also, consumers will still be able to buy products over the internet from locations outside European Union jurisdiction. Potential purchasers need to know, in both the short term and the long term, how to purchase herbal products which provide the information they need for the safe use of these products.
Journal Article
Can a Public and Patient Involvement (PPI) Informed Participant Information Leaflet (PIL) Improve Trial Recruitment, Retention, and Quality of Decision Making? Results of a Randomised Controlled Double‐Blind Study Within a Trial (SWAT)
2025
Introduction Public and patient involvement (PPI) may be utilised to improve aspects of trial conduct. This study within a trial (SWAT) aimed to examine if a PPI‐informed participant information leaflet (PIL) could improve recruitment, retention, and quality of decision‐making of an exercise‐based rehabilitation trial (RESTORE II) for upper gastrointestinal (UGI) cancer survivors. Methods This SWAT was conducted over two phases. Phase 1 applied qualitative methods to develop and refine a PPI‐informed PIL. Phase 2 embedded a randomised controlled double‐blind SWAT within the RESTORE II trial, comparing a standard PIL (PIL A) to the PPI‐informed PIL (PIL B) in terms of recruitment, retention, and quality of decision‐making (Decision Making Questionnaire [DMQ]). Results Phase 1 recruited 16 PPI members (mean age 67.01 [9.28] years, mostly male [81.25%] and all UGI cancer survivors). Participants reviewed the standard PIL A and made suggestions for improvement, including revisions to the layout, title, text, provision of key information on the first page, and greater emphasis on the potential benefits of participation. This feedback was used to draft the alternative PIL B, which the Phase 1 participants reviewed and refined through minor changes to the appearance, text, and layout. In Phase 2, 307 potential RESTORE II trial participants were randomised to receive either PIL A (n = 154) or PIL B (n = 153). The overall recruitment rate was 28.7%. (PIL A 26.6% vs. PIL B 30.7%, OR 1.22 [95% CI 0.74 to 2.01, p = 0.43]), retention was 84.1% (PIL A 85.4% vs. PIL B 83.0%, OR 0.84 [95% CI 0.26 to 2.65, p = 0.760]). No significant difference in mean (SD) DMQ scores was observed: PIL A: 29.1 (4.4) vs. PIL B: 29.1 (5.1) (mean difference 0.03, 95% CI −1.64 to 1.69, p = 0.49). Conclusions A PPI‐informed PIL did not improve recruitment, retention, or decision‐making for the RESTORE II trial. Patient or Public Contribution Patients with UGI cancer informed the development of the interventional PIL B. Author P.B. provided input from the patient's perspective throughout the SWAT as a member of the Trial Steering Committee, providing oversight to the SWAT management, and contributed to analysis and the production of this manuscript. Trial Registration SWAT Registration: The Northern Ireland Hub for Trials Methodology Research, SWAT Store, SWAT 100 https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoupload,914713,en.pdf. Host Trial Registration Clinical Trials. gov https://clinicaltrials.gov/study/NCT03958019.
Journal Article
Prevention of mood disorder after stroke: a randomised controlled trial of problem solving therapy versus volunteer support
2019
Background
Mood disorder after stroke is common but drug and psychosocial treatments have been assessed with disappointing results. Preventing mood disorder from developing in the first place could be a better approach and might reduce the need for pharmacotherapy in this predominantly older patient group. We used a brief problem-solving therapy and evaluated its effect in reducing mood disorder in the 12 months after stroke.
Methods
A 3-group, parallel, randomised controlled trial. Four hundred fifty patients with stroke were randomised within 1 month of hospital admission to problem-solving therapy from a psychiatric nurse, non-specific support given by volunteers or treatment-as-usual. Follow up took place at 6 and 12 months after stroke.
Standardised measures of mood (Present State Examination, GHQ-28), cognitive state (mini-mental state examination) and function (Barthel ADL index, Frenchay Activities Index) were taken at baseline, 6 and 12 months after randomisation. Satisfaction with care was recorded at follow up.
Results
At 6 months, all psychological and activity measures favoured problem-solving therapy. At 12 months, patients in the problem-solving therapy group had significantly lower GHQ-28 scores and lower median Present State Examination symptom scores. There were no statistically significant differences in activity. The problem-solving therapy group were more satisfied with some aspects of care.
Conclusions
The results are encouraging and suggest it is possible to prevent mood disorder in stroke patients using a psychological intervention. The differences between the groups at 12 months may indicate a sustained impact of psychological therapies, by comparison with non-specific support.
Trial registration
ISRCTN:
ISRCTN33773710
Registered: 23/01/2004 (Retrospectively).
Journal Article