scholarly journals Understanding successful development of complex health and healthcare interventions and its drivers from the perspective of developers and wider stakeholders: an international qualitative interview study

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e028756 ◽  
Author(s):  
Katrina M Turner ◽  
Nikki Rousseau ◽  
Liz Croot ◽  
Edward Duncan ◽  
Lucy Yardley ◽  
...  
Keyword(s):  
Real World ◽  
Development Process ◽  
Intervention Development ◽  
Grant Application ◽  
Successful Intervention ◽  
Qualitative Interview Study ◽  
Healthcare Interventions ◽  
Randomised Controlled ◽  
The Uk

ObjectiveIdentify how individuals involved in developing complex health and healthcare interventions (developers), and wider stakeholders in the endeavour, such as funders, define successful intervention development and what factors influence how interventions are developed.DesignIn-depth interviews with developers and wider stakeholders to explore their views and experiences of developing complex health and healthcare interventions.SettingInterviews conducted with individuals in the UK, Europe and North America.ParticipantsTwenty-one individuals were interviewed: 15 developers and 6 wider stakeholders. Seventeen participants were UK based.ResultsMost participants defined successful intervention development as a process that resulted in effective interventions that were relevant, acceptable and could be implemented in real-world contexts. Accounts also indicated that participants aimed to develop interventions that end users wanted, and to undertake a development process that was methodologically rigorous and provided research evidence for journal publications and future grant applications. Participants’ ambitions to develop interventions that had real-world impact drove them to consider the intervention’s feasibility and long-term sustainability early in the development process. However, this process was also driven by other factors: the realities of resource-limited health contexts; prespecified research funder priorities; a reluctance to deviate from grant application protocols to incorporate evidence and knowledge acquired during the development process; limited funding to develop interventions and the need for future randomised controlled trials (RCTs) to prove effectiveness. Participants expressed concern that these drivers discouraged long-term thinking and the development of innovative interventions, and prioritised evaluation over development and future implementation.ConclusionsTensions exist between developers’ goal of developing interventions that improve health in the real world, current funding structures, the limited resources within healthcare contexts, and the dominance of the RCT for evaluation of these interventions. There is a need to review funding processes and expectations of gold standard evaluation.

scholarly journals Guidance for reporting intervention development studies in health research (GUIDED): an evidence-based consensus study

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e033516 ◽  
Author(s):  
Edward Duncan ◽  
Alicia O'Cathain ◽  
Nikki Rousseau ◽  
Liz Croot ◽  
Katie Sworn ◽  
...  
Keyword(s):  
Health Research ◽  
Development Process ◽  
Public Involvement ◽  
Evidence Theory ◽  
Intervention Development ◽  
Target Population ◽  
Development Research ◽  
Qualitative Interview Study ◽  
The Uk ◽  
Delphi Studies

ObjectiveTo improve the quality and consistency of intervention development reporting in health research.DesignThis was a consensus exercise consisting of two simultaneous and identical three-round e-Delphi studies (one with experts in intervention development and one with wider stakeholders including funders, journal editors and public involvement members), followed by a consensus workshop. Delphi items were systematically derived from two preceding systematic reviews and a qualitative interview study.ParticipantsIntervention developers (n=26) and wider stakeholders (n=18) from the UK, North America and Europe participated in separate e-Delphi studies. Intervention developers (n=13) and wider stakeholders (n=13) participated in a 1-day consensus workshop.Resultse-Delphi participants achieved consensus on 15 reporting items. Following feedback from the consensus meeting, the final inclusion and wording of 14 items with description and explanations for each item were agreed. Items focus on context, purpose, target population, approaches, evidence, theory, guiding principles, stakeholder contribution, changes in content or format during the development process, required changes for subgroups, continuing uncertainties, and open access publication. They form the GUIDED (GUIDance for the rEporting of intervention Development) checklist, which contains a description and explanation of each item, alongside examples of good reporting.ConclusionsConsensus-based reporting guidance for intervention development in health research is now available for publishers and researchers to use. GUIDED has the potential to lead to greater transparency, and enhance quality and improve learning about intervention development research and practice.

scholarly journals How user knowledge of psychotropic drug withdrawal resulted in the development of person-specific tapering medication

2020 ◽  
Vol 10 ◽  
pp. 204512532093245 ◽  
Author(s):  
Peter C. Groot ◽  
Jim van Os
Keyword(s):  
Psychotropic Drug ◽  
Drug Withdrawal ◽  
Full Agreement ◽  
Randomised Controlled ◽  
The Uk ◽  
User Knowledge ◽  
First Time ◽  
Academic Strategy ◽  
Discontinuation Syndrome

Coming off psychotropic drugs can cause physical as well as mental withdrawal, resulting in failed withdrawal attempts and unnecessary long-term drug use. The first reports about withdrawal appeared in the 1950s, but although patients have been complaining about psychotropic withdrawal problems for decades, the first tentative acknowledgement by psychiatry only came in 1997 with the introduction of the ‘antidepressant-discontinuation syndrome’. It was not until 2019 that the UK Royal College of Psychiatrists, for the first time, acknowledged that withdrawal can be severe and persistent. Given the lack of a systematic professional response, over the years, patients who were experiencing withdrawal started to work out practical ways to safely come off medications themselves. This resulted in an experience-based knowledge base about withdrawal which ultimately, in The Netherlands, gave rise to the development of person-specific tapering medication (so-called tapering strips). Tapering medication enables doctors, for the first time, to flexibly prescribe and adapt the medication required for responsible and person-specific tapering, based on shared decision making and in full agreement with recommendations in existing guidelines. Looking back, it is obvious that the simple practical solution of tapering strips could have been introduced much earlier, and that the traditional academic strategy of comparisons from randomised trials is not the logical first step to help individual patients. While randomised controlled trials (RCTs) are the gold standard for evaluating interventions, they are unable to accommodate the heterogeneity of individual responses. Thus, a more individualised approach, building on RCT knowledge, is required. We propose a roadmap for a more productive way forward, in which patients and academic psychiatry work together to improve the recognition and person-specific management of psychotropic drug withdrawal.

scholarly journals Long term effects of once-only flexible sigmoidoscopy screening after 17 years of follow-up: the UK Flexible Sigmoidoscopy Screening randomised controlled trial

The Lancet ◽  
2017 ◽  
Vol 389 (10076) ◽  
pp. 1299-1311 ◽  
Author(s):  
Wendy Atkin ◽  
Kate Wooldrage ◽  
D Maxwell Parkin ◽  
Ines Kralj-Hans ◽  
Eilidh MacRae ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Flexible Sigmoidoscopy ◽  
Controlled Trial ◽  
Long Term Effects ◽  
Randomised Controlled ◽  
The Uk

scholarly journals Development of an Interactive Lifestyle Programme for Adolescents at Risk of Developing Type 2 Diabetes: PRE-STARt

Children ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. 69
Author(s):  
Deirdre M. Harrington ◽  
Emer M. Brady ◽  
Susann Weihrauch-Bluher ◽  
Charlotte L. Edwardson ◽  
Laura J. Gray ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
At Risk ◽  
Young People ◽  
Development Process ◽  
Intervention Development ◽  
Risk Groups ◽  
Stakeholder Input ◽  
Programme Content ◽  
The Uk

Background: Type 2 diabetes (T2D) is increasing in young people. Reporting on the processes used when developing prevention interventions is needed. We present the development of a family-based interactive lifestyle intervention for adolescents with risk factors for T2D in the future. Method: A multidisciplinary team in the UK site led the intervention development process with sites in Portugal, Greece, Germany and Spain. Potential programme topics and underpinning theory were gathered from literature and stakeholders. A theoretical framework based on self-efficacy theory and the COM-B (capability, opportunity, motivation, behaviour) model was developed. Sessions and supporting resources were developed and refined via two iterative cycles of session and resource piloting, feedback, reflection and refinement. Decision on delivery and content were made by stakeholders (young people, teachers, parents, paediatricians) and all sites. Materials were translated to local languages. Site-specific adaptations to the language, content and supporting resources were made. Results: The “PRE-STARt” programme is eight 90-min interactive sessions with supporting curriculum and resources. Iterative development work provided valuable feedback on programme content and delivery. Conclusion: Reporting on the intervention development process, which includes stakeholder input, could yield a flexible approach for use in this emerging ‘at risk’ groups and their families.

scholarly journals An engaged research study to assess the effect of a ‘real-world’ dietary intervention on urinary bisphenol A (BPA) levels in teenagers

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e018742 ◽  
Author(s):  
Tamara S Galloway ◽  
Nigel Baglin ◽  
Benjamin P Lee ◽  
Anna L Kocur ◽  
Maggie H Shepherd ◽  
...  
Keyword(s):  
Bisphenol A ◽  
Qualitative Analysis ◽  
Real World ◽  
Intervention Study ◽  
Dietary Intervention ◽  
Positive Association ◽  
Western World ◽  
Real World Setting ◽  
The Uk

ObjectiveBisphenol A (BPA) has been associated with adverse human health outcomes and exposure to this compound is near-ubiquitous in the Western world. We aimed to examine whether self-moderation of BPA exposure is possible by altering diet in a real-world setting.DesignAn Engaged Research dietary intervention study designed, implemented and analysed by healthy teenagers from six schools and undertaken in their own homes.ParticipantsA total of 94 students aged between 17 and 19 years from schools in the South West of the UK provided diet diaries and urine samples for analysis.InterventionResearcher participants designed a set of literature-informed guidelines for the reduction of dietary BPA to be followed for 7 days.Main outcome measuresCreatinine-adjusted urinary BPA levels were taken before and after the intervention. Information on packaging and food/drink ingested was used to calculate a BPA risk score for anticipated exposure. A qualitative analysis was carried out to identify themes addressing long-term sustainability of the diet.ResultsBPA was detected in urine of 86% of participants at baseline at a median value of 1.22 ng/mL (IQR 1.99). No effect of the intervention diet on BPA levels was identified overall (P=0.25), but there was a positive association in those participants who showed a drop in urinary BPA concentration postintervention and their initial BPA level (P=0.003). Qualitative analysis identified themes around feelings of lifestyle restriction and the inadequacy of current labelling practices.ConclusionsWe found no evidence in this self-administered intervention study that it was possible to moderate BPA exposure by diet in a real-world setting. Furthermore, our study participants indicated that they would be unlikely to sustain such a diet long term, due to the difficulty in identifying BPA-free foods.

scholarly journals Real World Learning and the Internationalisation of Higher Education: Approaches to Making Learning Real for Global Communities

2020 ◽  
pp. 107-132
Author(s):  
Md Golam Jamil ◽  
Nazmul Alam ◽  
Natascha Radclyffe-Thomas ◽  
Mohammad Aminul Islam ◽  
A. K. M. Moniruzzaman Mollah ◽  
...  
Keyword(s):  
Higher Education ◽  
Learning Styles ◽  
Real World ◽  
Internationalisation Of Higher Education ◽  
Diverse Learning ◽  
Real World Learning ◽  
Practical Guidelines ◽  
Citizenship Skills ◽  
The Uk

Abstract Real world learning and the internationalisation of curricula are relatively new considerations in contemporary higher education discourses. Inquiry and application lie at the heart of real world learning, and the internationalisation of academic programmes is expected to equip learners with diverse learning styles and global citizenship skills. However, combining these two sets of educational objectives for pedagogic success is challenging, mainly because of learners’ academic, social and cultural differences. The chapter addresses this problem theoretically and with the help of three real cases drawn from the UK and Bangladesh. The cases convey the ethos and procedures for accommodating diversity, inquiry, application of learning, and cross-cultural collaboration in international educational settings. The findings suggest several practical guidelines on creating authentic and long-term learning opportunities in higher education.

scholarly journals Success of 4CMenB in preventing meningococcal disease: evidence from real-world experience

2020 ◽  
Vol 105 (8) ◽  
pp. 784-790 ◽  
Author(s):  
Catherine Isitt ◽  
Catherine A Cosgrove ◽  
Mary Elizabeth Ramsay ◽  
Shamez N Ladhani
Keyword(s):  
Real World ◽  
Meningococcal Disease ◽  
Large Scale ◽  
Safety Data ◽  
Case Fatality ◽  
Sudden Onset ◽  
Rapid Progression ◽  
Real World Data ◽  
The Uk

Meningococcal disease remains one of the most feared infectious diseases worldwide because of its sudden onset, rapid progression and high case fatality rates, while survivors are often left with severe long-term sequelae. Young children have the highest incidence of invasive meningococcal disease (IMD), and nearly all cases in the UK, as in most of Europe and many other industrialised countries, are due to group B meningococci (MenB). The licensure of a broad-coverage, recombinant protein-based MenB vaccine (4CMenB) in 2013 was, therefore, heralded a major breakthrough in the fight against IMD. This vaccine was, however, licensed on immunogenicity and reactogenicity studies only, raising uncertainties about field effectiveness, long-term safety and antibody persistence. In 2015, the UK became the first country to implement 4CMenB into the national infant immunisation schedule and, since then, several countries have followed suit. Seven years after licensure, a wealth of real-world data has emerged to confirm 4CMenB effectiveness, along with large-scale safety data, duration of protection in different age groups, successful strategies to reduce vaccine reactogenicity, impact on carriage in adolescents and the potential for 4CMenB to protect against other meningococcal serogroups and against gonorrhoea. A number of questions, however, remain unanswered, including the investigation and management of vaccine-associated fever in infants, as well as disease severity and assessment of breakthrough cases in immunised children. Increasing use of 4CMenB will provide answers in due course. We now have vaccines against all the major serogroups causing IMD worldwide. Next-generation and combination vaccines against multiple serogroups look very promising.

Flexible Sigmoidoskopie kann viele Leben retten

2017 ◽  
Vol 79 (08/09) ◽  
pp. 590-590
Keyword(s):  
Flexible Sigmoidoscopy ◽  
Controlled Trial ◽  
Imperial College ◽  
Prevention Research ◽  
Long Term Effects ◽  
Screening And Prevention ◽  
Randomised Controlled ◽  
The Uk

Atkin W et al. Long term effects of once-only flexible sigmoidoscopy screening after 17 years of follow-up: the UK Flexible Sigmoidoscopy Screening randomised controlled trial. Lancet 2017; 389: 1299–1311 Die Beobachtungsdauer zur Darmkrebsfrüherkennung mittels einer flexiblen Sigmoidoskopie im Alter zwischen 55 und 64 Jahren liegt inzwischen in Großbritannien bei 17 Jahren. Die von Wendy Atkin von der Cancer Screening and Prevention Research Group am Imperial College in London und Kollegen vorgestellten Ergebnisse bestätigen den Effekt des Darmkrebsscreenings mittels Endoskopie selbst bei einer einmaligen und begrenzten Maßnahme wie dieser.

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