scholarly journals An evidence base to optimise methods for involving patient and public contributors in clinical trials: a mixed-methods study

2015 ◽  
Vol 3 (39) ◽  
pp. 1-142 ◽  
Author(s):  
Carrol Gamble ◽  
Louise Dudley ◽  
Alison Allam ◽  
Philip Bell ◽  
Deborah Buck ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Mixed Methods ◽  
Public Involvement ◽  
Research Collaboration ◽  
Research Programme ◽  
Evidence Base ◽  
Research Community ◽  
Future Research ◽  
Randomised Trials ◽  
Managerial Roles

BackgroundIn comparison with other study designs, randomised trials are regarded as particularly likely to benefit from patient and public involvement (PPI). Using mixed-methods research we investigated PPI from the perspectives of researchers and PPI contributors.MethodsRandomised trials in receipt of funding from the Health Technology Assessment (HTA) programme between 2006 and 2010 were identified. Funding applications and board and referee comments were obtained and data relevant to PPI extracted. Chief investigators (CIs), PPI contributors and UK Clinical Research Collaboration Registered Clinical Trials Units (RCTUs) were surveyed. Interviews were conducted with researchers and PPI contributors.ResultsA total of 111 trials were included. Text relevant to PPI was identified in half of the trials for which the first-stage applications were available, but only one-quarter described PPI within their development. In the second stage of the application, the majority provided some text relevant to PPI, with over half having PPI in their development. Fewer than half of referees commented on PPI, and funding boards rarely provided comments in relation to PPI. Seventy-three per cent (81 of 111) of CIs responded to the survey and 98% (79 of 81) included PPI at some stage in their trial. CIs considered high impact from PPI contributors to occur more frequently in trial setup, with low or no impact being more common during trial conduct, analysis and dissemination. Only one-third of CIs provided PPI contributor contact details but all contributors contacted completed the survey. The majority of contributors felt engaged and valued by the research team. Interviews were conducted with researchers and/or PPI contributors for 28 trials identifying two main influences on perception of PPI impact: whether or not CIs expressed personal goals and plans for PPI; and the quality of their relationship with the PPI contributors. The importance of early engagement was identified, with opportunity for input thereafter limited. Three PPI roles were identified: oversight, managerial and responsive. Oversight roles, as required by funders, were associated with low impact in comparison with responsive or managerial roles. Most researchers could see some value in PPI training for researchers, although those that had received such training themselves expressed concerns about its purpose and evidence base. Training for PPI contributors was considered unnecessary, with conversational approaches preferred, although this did not appear to provide an opportunity for role negotiation. The RCTU survey response rate was 85% (39 of 46). The majority (37 of 39) reported PPI within trials co-ordinated by their unit. Trial characteristics were used by half to determine the approach to PPI. Two-thirds reported recent developments or changes in implementing plans for PPI (21 of 33). Support to PPI contributors was commonly offered through members of staff at the unit.ConclusionsPPI is occurring in the majority of trials funded by the HTA programme, but uncertainty remains about how it is assessed and valued. Early involvement, building a relationship between researchers and contributors, responsive or managerial roles, and having defined goals for PPI were associated with impact. Efficiency could be gained by utilising the RCTU network to identify and tackle challenges, and develop a risk-based approach utilising trial characteristics. Recommendations are made to trial funders and the research community. Given the difficulties for some informants in recalling PPI contributions, future research using a prospective approach would be valuable. Ethnographic research that combines observation and multi-informant interviews is likely to be informative in identifying impact. The research community needs to give further consideration to processes for selecting PPI contributors and models of implementing PPI.FundingThe National Institute for Health Research Health Services and Delivery Research programme and INVOLVE.

scholarly journals Improving practice in safeguarding at the interface between hospital services and children’s social care: a mixed-methods case study

2015 ◽  
Vol 3 (4) ◽  
pp. 1-164 ◽  
Author(s):  
Susan White ◽  
David Wastell ◽  
Suzanne Smith ◽  
Christopher Hall ◽  
Emilie Whitaker ◽  
...  
Keyword(s):  
Patient Safety ◽  
Mixed Methods ◽  
Child Protection ◽  
Social Care ◽  
Research Programme ◽  
Unintended Consequences ◽  
Primary Site ◽  
Hospital Environment ◽  
Future Research ◽  
The Impact

BackgroundHospital settings have an important impact on children harmed by parents and carers. Concern arises from the capacity of these settings to respond effectively to individual needs despite increased NHS policy awareness and actions on safeguarding. Patient safety initiatives have rarely modelled in detail the social and cultural dynamics of child health settings and children’s safeguarding. This study is focused on supporting and evaluating clinician-led service design in an acute trust. A suite of initiatives and artefacts has been designed, based on sociotechnical principles, on the premise that only a thorough understanding of human, social and organisational challenges will afford effective solutions.ObjectivesThe study addresses the following primary question: ‘Can a safeguarding culture be designed within the hospital environment that will provide the conditions for the detection of children at risk of abuse and support protective actions before discharge, including collaboration with external agencies?’ Objectives include the development of a sociologically rich understanding of why diagnostic failures and communication breakdowns occur; the design of a suite of integrated interventions for promoting a positive safety culture, following a user-centred approach; and the evaluation of the effectiveness of this package, including its generalisability across sites.DesignThe study took place in two sites: the primary site where the initiatives were developed and a further site with the original intention of transferring developments. The investigation follows a broaddesign scienceapproach. The evaluation of a design intervention relies on a rigorous understanding of the realities of everyday practice, and the study thus draws on mixed methods to examine the impact of service redesign on cultures and practices.FindingsThe data suggest that safeguarding children can become mainstream patient safety business. Board support is vital. In our primary site, there has been a steady integration of learning from serious case reviews and other child protection-related processes with ‘patient safety’-related incidents, with growing recognition that similar systemic issues impact on both domains. Making use of a familiar vocabulary to redescribesafeguardingas asafetyissue, and thus as something fundamental to the functions of an acute hospital, has been part of the success. The data suggest that persistence, resilience and vigilance from the safeguarding leadership and executive teams are crucial. Current policy includes the development of the Child Protection Information Sharing project, which is intended to improve information flow between the NHS, particularly hospitals and children’s social care. The findings from this study suggest the importance of good design, piloting, incrementalism and a thorough empirical engagement with everyday practices during implementation of this and any future information systems based reform.ConclusionsSafeguarding takes place in a complex system and even minor changes within any part of that system can impact on the rest in unpredictable ways. It is important that managers adopt a ‘design attitude’ and seek to mitigate unintended consequences through careful experimentation. The findings suggest the need for the design of systems to enhance communication and not simply to ‘share information’. Technological solutions impact on everyday decision-making and can have unintended consequences. Attention to forces of change and stasis in health settings, the factors affecting technology transfer and the impact of the configuration of local authority services are suggested as a key priorities for future research.FundingThe National Institute for Health Research Health Services and Delivery Research programme.

scholarly journals The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

BMJ ◽  
2020 ◽  
pp. m115 ◽  
Author(s):  
Munyaradzi Dimairo ◽  
Philip Pallmann ◽  
James Wason ◽  
Susan Todd ◽  
Thomas Jaki ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adaptive Design ◽  
Randomised Trial ◽  
Adaptive Designs ◽  
Future Research ◽  
Randomised Trials ◽  
Public And Private ◽  
Key Stakeholders ◽  
Potential Benefits ◽  
Explanatory Text

AbstractAdaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to reproduce and are hard to interpret and synthesise. This consequently hampers their ability to inform practice as well as future research and contributes to research waste. Better transparency and adequate reporting will enable the potential benefits of ADs to be realised.This extension to the Consolidated Standards Of Reporting Trials (CONSORT) 2010 statement was developed to enhance the reporting of randomised AD clinical trials. We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private sectors from 21 countries, followed by a consensus meeting. Members of the CONSORT Group were involved during the development process.The paper presents the ACE checklists for AD randomised trial reports and abstracts, as well as an explanation with examples to aid the application of the guideline. The ACE checklist comprises seven new items, nine modified items, six unchanged items for which additional explanatory text clarifies further considerations for ADs, and 20 unchanged items not requiring further explanatory text. The ACE abstract checklist has one new item, one modified item, one unchanged item with additional explanatory text for ADs, and 15 unchanged items not requiring further explanatory text.The intention is to enhance transparency and improve reporting of AD randomised trials to improve the interpretability of their results and reproducibility of their methods, results and inference. We also hope indirectly to facilitate the much-needed knowledge transfer of innovative trial designs to maximise their potential benefits.

scholarly journals Patient and public involvement in numerical aspects of trials: a mixed methods theory-informed survey of trialists’ current practices, barriers and facilitators

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e046977
Author(s):  
Beatriz Goulao ◽  
Camille Poisson ◽  
Katie Gillies
Keyword(s):  
Mixed Methods ◽  
Online Survey ◽  
Public Involvement ◽  
Theoretical Domains Framework ◽  
Patient And Public Involvement ◽  
Barriers And Facilitators ◽  
Future Research ◽  
Mixed Methods Approach ◽  
Scarce Resources ◽  
The Public

ObjectiveWe aimed to find out if trialists involve patients and the public in numerical aspects of trials, how and what are the barriers and facilitators to doing it.DesignWe developed a survey based on the Theoretical Domains Framework. We used a mixed methods approach to analyse the data and to identify important domains.SettingOnline survey targeting UK-based trial units.ParticipantsStakeholders working in UK-based clinical trials, 18 years old or over, understand English and agree to take part in the study.Outcome measuresTrialists’ behaviour of involving patients and the public in numerical aspects of trials and its determinants.ResultsWe included 187 respondents. Majority were female (70%), trial managers (67%) and involved public and patient partners in numerical aspects of trials (60%). We found lack of knowledge, trialists’ perception of public and patient partners’ skills, capabilities and motivations, scarce resources, lack of reinforcement, and lack of guidance were barriers to involving public and patient partners in numerical aspects of trials. Positive beliefs about consequences were an incentive to doing it.ConclusionsMore training, guidance and funding can help trialists involve patient and public partners in numerical aspects, although they were uncertain about public and patient partners’ motivation to be involved. Future research should focus on identifying public and patient partners’ motivations and develop strategies to improve the communication of numerical aspects.

scholarly journals Supply Chain Innovation in Scientific Research Collaboration

2019 ◽  
Vol 11 (3) ◽  
pp. 753 ◽  
Author(s):  
Chih-Hung Yuan ◽  
Yenchun Wu ◽  
Kune-muh Tsai
Keyword(s):  
United States ◽  
Supply Chain ◽  
Research Collaboration ◽  
The United States ◽  
Research Community ◽  
Future Research ◽  
Collaborative Network ◽  
Collaboration Networks ◽  
Research Papers ◽  
The United Kingdom

Innovations in supply chains and logistics, which help businesses reduce their costs and meet customer needs, have become increasingly vital. In this study, we first conducted a content analysis followed by a social network analysis to systematically review 104 research papers on supply chain innovation (SCI) that were published between 1987 and 2018. The results suggest that SCI research was originally concentrated in the United States and did not receive much attention in Europe and Asia, until more recently. An analysis of collaboration networks indicates that an SCI research community has just started to form, with the United Kingdom at the center of the international collaborative network. Implications of the study and directions for future research are summarized in detail, based on the systematic literature review.

scholarly journals Canadian contributions to research on neglected tropical diseases

2021 ◽  
Vol 15 (7) ◽  
pp. e0009476
Author(s):  
Theresa W. Gyorkos ◽  
Hélène Carabin ◽  
Maneesh Phillip ◽  
Leshawn Benedict ◽  
Amy Davis ◽  
...  
Keyword(s):  
Neglected Tropical Diseases ◽  
Evidence Base ◽  
Research Community ◽  
World Health ◽  
Future Research ◽  
Tropical Diseases ◽  
Road Map ◽  
The World ◽  
Canadian Provinces ◽  
Canadian Research

Background The World Health Organization’s (WHO) Neglected Tropical Disease (NTD) Road Map for 2021–2030 was recently endorsed by all member states at the World Health Assembly in November 2020. Although only 3 of the 20 NTDs are endemic in Canada (i.e., echinococcosis, rabies, and scabies), the Canadian research community has contributed to advancing the knowledge base of all 20 NTDs. Previous research comprehensively detailed Canadian research on 11 NTDs between 1950 and 2010 using a network analysis approach. The specific objective of the present analysis was to update the publication record over the last decade (2010–2019) to include all 20 NTDs. Materials and methods A bibliometric analysis was conducted in Scopus and Web of Science databases (for English or French articles published between January 1, 2010 and December 31, 2019) using appropriate search terms for each of the 20 NTDs and where at least 1 of the authors had a Canadian institution address. A 21st search was added to include publications including multiple NTDs or a discussion of NTDs in general. Following assessment of inclusion and exclusion criteria, 2 reviewers independently screened all abstracts, with discordant observations rereviewed to arrive at an agreement. Duplicates were removed. Results A total of 1,790 publications were retrieved (1,738 with a disease–specific NTD focus and 52 with a general NTD focus, resulting in 1,659 unique publications), giving an average of over 160 articles per year. Over 80% were classified as full–length research articles. The top 3 journals in terms of frequency were PLOS Neglected Tropical Diseases, PLOS ONE, and the American Journal of Tropical Medicine and Hygiene. Authors’ institutions were from all Canadian provinces. While all 20 NTDs were addressed in these publications, the 5 most commonly studied were leishmaniasis, dengue fever and chikungunya, Chagas disease, soil–transmitted helminthiases, and rabies. Conclusions Canadian researchers across the country have contributed to the evidence base of all 20 NTDs, publishing an average of over 160 publications per year between 2010 and 2019. As WHO NTD Road Map 2021–2030 rolls out globally, the Canadian research community, in collaboration with its partners and in solidarity with people living in vulnerable circumstances in endemic regions worldwide, is well positioned to meet future research challenges so that the goal of eliminating the disease burden attributable to NTDs can be achieved.

scholarly journals The Adaptive designs CONSORT Extension (ACE) Statement: A checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

2019 ◽  
Author(s):  
Munyaradzi Dimairo ◽  
Philip Pallmann ◽  
James Wason ◽  
Susan Todd ◽  
Thomas Jaki ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adaptive Design ◽  
Randomised Trial ◽  
Adaptive Designs ◽  
Future Research ◽  
Randomised Trials ◽  
Public And Private ◽  
Key Stakeholders ◽  
Potential Benefits ◽  
Explanatory Text

Abstract Background Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to reproduce and are hard to interpret and synthesise. This consequently hampers their ability to inform practice as well as future research and contributes to research waste. Better transparency and adequate reporting will enable the potential benefits of ADs to be realised. Methods This extension to the Consolidated Standards Of Reporting Trials (CONSORT) 2010 Statement was developed to enhance the reporting of randomised AD clinical trials. We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private sectors from 21 countries, followed by a consensus meeting. Members of the CONSORT Group were involved during the development process. Results The paper presents the ACE checklists for AD randomised trial reports and abstracts, as well as an explanation with examples to aid the application of the guideline. The ACE checklist is comprised of seven new items, nine modified items, six unchanged items for which additional explanatory text clarifies further considerations for ADs, and 20 unchanged items not requiring further explanatory text. The ACE abstract checklist has one new item, one modified item, one unchanged item with additional explanatory text for ADs, and 15 unchanged items not requiring further explanatory text. Conclusions The intention is to enhance transparency and improve reporting of AD randomised trials to improve the interpretability of their results and reproducibility of their methods, results and inference. We also hope indirectly to facilitate the much-needed knowledge transfer of innovative trial designs to maximise their potential benefits.

scholarly journals CART-WHEEL.org: An Ethically Approved Online Database for Patient-Entered Data to Facilitate Rare Cancer Research

2020 ◽  
pp. 136-146
Author(s):  
Damien Kee ◽  
Clare Parker ◽  
Susie Bae ◽  
Katherine M. Tucker ◽  
Michelle Harrison ◽  
...  
Keyword(s):  
Cancer Research ◽  
Clinical Trials ◽  
Clinical Information ◽  
Research Process ◽  
Evidence Base ◽  
Future Research ◽  
Specific Information ◽  
Rare Cancer ◽  
Cancer Data ◽  
Power Studies

PURPOSE Rare cancers are challenging for researchers, as clinicians and scientists have difficulty recruiting sufficient patient cases to power studies appropriately. Likewise, patients often are frustrated by a lack of specific information or evidence base for their cancer and, although eager to participate in research, have limited opportunities. We established CART-WHEEL.org, an online patient-entered database, to directly engage patients in the research process, collect rare cancer data, and facilitate their entry into additional research. PATIENTS AND METHODS Patients access CART-WHEEL.org directly online. Clinical information is collected from users via a streamlined questionnaire developed collaboratively with consumer groups to ensure accessibility and relevance. Data collected include the following: patient demographics, comorbidities, and risk factors and tumor diagnostic, biomarker, and treatment history. Patients can download a medical summary for personal use; consent for research use of data; and indicate willingness to be contacted about other research or clinical trials. We describe data collected to date and its validation, and we provide examples of how CART-WHEEL.org can facilitate rare cancer research. RESULTS From January 2010 to March 2018, 558 patients provided consent and entered their rare cancer data. One hundred distinct rare tumor types and patients from 22 countries were included. Validation of data entered by 21 patients with sarcoma against a hospital database demonstrated accuracy sufficient to facilitate future research in key fields, such as tumor site (95%) and histopathologic diagnosis (90%). Examples of CART-WHEEL–based disease-specific projects, subsequent recruitment to other rare cancer projects, and rare cancer patient cases of interest are described. CONCLUSIONS Online platforms like CART-WHEEL.org can engage consumers directly, facilitating collection of patient-entered rare cancer data for hypothesis generation, and connect patients with researchers to enable specific rare cancer research and clinical trials.

scholarly journals Delivering the aims of the Collaborations for Leadership in Applied Health Research and Care: understanding their strategies and contributions

2015 ◽  
Vol 3 (25) ◽  
pp. 1-208 ◽  
Author(s):  
Bryony Soper ◽  
Saba Hinrichs ◽  
Samuel Drabble ◽  
Ohid Yaqub ◽  
Sonja Marjanovic ◽  
...  
Keyword(s):  
Health Research ◽  
Public Involvement ◽  
Scale Up ◽  
Research Programme ◽  
Health Science ◽  
Future Research ◽  
Patient Benefit ◽  
Research Knowledge ◽  
Applied Health Research ◽  
Use Of Research

BackgroundIn 2008, the National Institute for Health Research (NIHR) in England established nine Collaborations for Leadership in Applied Health Research and Care (CLAHRCs) to develop partnerships between universities and local NHS organisations focused on improving patient outcomes through the conduct and application of applied health research.ObjectivesThe study explored how effectively the CLAHRCs supported the ‘translation’ of research into patient benefit, and developed ways of doing applied research that maximised its chances of being useful to the service and the capacity of the NHS to respond. It focused on three issues: (1) how the NHS influenced the CLAHRCs, and vice versa; (2) how effective multistakeholder and multidisciplinary research and implementation teams were built in the CLAHRCs; (3) how the CLAHRCs supported the use of research knowledge to change commissioning and clinical behaviour for patient benefit.MethodsThe study adopted an adaptive and emergent approach and incorporated a formative evaluation. An initial phase mapped the landscape of all nine CLAHRCs and the context within which they were established, using document analysis, workshops and interviews, and a literature review. This mapping exercise identified the three research questions that were explored in phase 2 through a stakeholder survey of six CLAHRCs, in-depth case studies of two CLAHRCs, validation interviews with all nine CLAHRCs and the NIHR, and document review.Results(1) The local remit and the requirement for matched NHS funding enhanced NHS influence on the CLAHRCs. The CLAHRCs achieved positive change among those most directly involved, but the larger issue of whether or not the CLAHRCs can influence others in and across the NHS remains unresolved. (2) The CLAHRCs succeeded in engaging different stakeholder groups, and explored what encouraged specific groups to become involved. Being responsive to people’s concerns and demonstrating ‘quick wins’ were both important. (3) There was some evidence that academics were becoming more interested in needs-driven research, and that commissioners were seeing the CLAHRCs as a useful source of support. A growing number of completed projects had demonstrated an impact on clinical practice.ConclusionsThe CLAHRCs have included NHS decision-makers in research and researchers in service decision-making, and encouraged research-informed practice. All the CLAHRCs (as collaborations) adopted relationship models. However, as the complexities of the challenges they faced became clearer, it became obvious that a focus on multidisciplinary relationships was necessary, but not sufficient on its own. Attention also has to be paid to the systems within and through which these relationships operate.Recommendations for researchFuture research should compare areas with an Academic Health Science Network (AHSN) and a CLAHRC with areas with just an AHSN, to understand the difference CLAHRCs make. There should be work on understanding implementation, such as the balancing of rigour and relevance in intervention studies; systemic barriers to and facilitators of implementation; and tailoring improvement interventions. There is also a need to better understand the factors that support the explicit use of research evidence across the NHS, and the processes and mechanisms that support the sustainability and scale-up of implementation projects. Research should place emphasis on examining the role of patient and public involvement in CLAHRCs and of the relation between CLAHRCs and NHS commissioners.FundingThe NIHR Health Services and Delivery Research programme.

Using corpora in depth psychology: a trigram-based analysis of a corpus of fetish fantasies

Corpora ◽  
2012 ◽  
Vol 7 (1) ◽  
pp. 69-90 ◽  
Author(s):  
Andrew Wilson
Keyword(s):  
Depth Psychology ◽  
Constant Pressure ◽  
Psychological Theory ◽  
Evidence Base ◽  
Future Research ◽  
German Language ◽  
Alternative Theory ◽  
Depth Psychological ◽  
Psychological Constructs ◽  
Quantitative Linguistics

Contemporary depth psychology is under constant pressure to demonstrate and strengthen its evidence base. In this paper, I show how the analysis of large corpora can contribute to this goal of developing and testing depth-psychological theory. To provide a basis for evaluating statements about foot and shoe fetishism, I analyse the thirty-six most frequent three-word phrases (or trigrams) in a corpus of about 1.6 million words of amateur fetish stories written in the German language. Zipfian methods from quantitative linguistics are used to specify the number of phrases for analysis and I argue that these reflect the core themes of the corpus. The analysis reveals three main dimensions. First, it corroborates the observations of the early sexologists that foot and shoe fetishism is very closely intertwined with sadomasochism. Secondly, it shows that genitalia-related phrases are also common, but an examination of their contexts questions Freud's theory that fetishism results from an assumption of female castration. Thirdly, it reveals that the mouth also plays a key role; however, the frequent co-presence of genitalia references in the same texts does not seem to support straightforwardly the most common alternative theory of fetishism based on object relations. Future research could valuably extend this approach to other fetishes and, in due course, to other depth-psychological constructs.

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