Direct access to potential research participants for a cohort study using a confidentiality waiver included in UK National Health Service legal statutes

OBJECTIVES: To describe our experience of using a confidentiality waiver (Section 251) in the National Health Service (NHS) Act to identify and recruit potential research participants to a cohort study and consider its use in a wider research context. DESIGN: Methodological discussion. SETTING: NHS Trusts in England. METHODS: We established a research recruitment process with quality health (QH), administrators of the National Cancer Patient Experience Survey, after an amendment to a Section 251 approval (reference number ECC-8-05d-2011). NHS Trusts agreeing to implement the process were requested to send the details of 16-24-year-olds, identified by a relevant ICD-10 code indicating a cancer diagnosis within a specified time period to QH. QH sent study information and a consent-to-be-contacted form which allowed QH to send details to BRIGHTLIGHT, for BRIGHTLIGHT to contact the treating team confirming eligibility and for an interviewer from Ipsos MORI to contact them. Written consent was to be obtained at interview. RESULTS: The method was implemented in 98 trusts; 75 supplied patient details. QH sent information to 441 young people, of whom 64 (15%) responded. Of these, 23 had already consented to participate. Adverse events were reported by 6 (1%) invitees: 4 were distressed because they did not have cancer, their details being submitted to QH due to incorrect hospital coding, and 1 young person was distressed about their diagnosis and requested no further contact and 1 young person found out they had cancer from the invitation. CONCLUSIONS: Application of Section 251 of the NHS Act (2006) to directly approach participants can facilitate recruitment to research projects where routinely collected NHS data are available to select eligible patients. The benefits of this method are that it requires fewer resources to recruit across multiple sites, and is quicker. Further information on the impact on bias and adverse event profile are required

A participatory study of teenagers and young adults views on access and participation in cancer research.

PURPOSE: The purpose of this study was to elicit young people's views on access and participation in cancer research. METHODS: Eight young people aged 18-25 years with a previous cancer diagnosis aged 15-24 participated in a one day workshop utilising participatory methodology. The workshop consisted of four exercises: role play/scene setting; focus group examining thoughts and opinions of research access and participation; individual reflection on access to different types of research; and creative interpretation of the workshop. Further consultation with 222 young people with cancer was conducted using an electronic survey. RESULTS: Three themes emerged: • Patient choice: Young people thought it was their right to know all options about available research. Without knowledge of all available studies they would be unable to make an informed choice about participation. • Role of healthcare professionals as facilitators/barriers: Young people suggested non-clinical healthcare professionals such as social workers and youth support coordinators may be more suited to approaching young people about participation in psychosocial and health services research. • Value of the research: The what, when and how information was delivered was key in relaying the value of the study and assisting young people in their decision to participate. Further consultation showed approximately 70% wanted to find out about all available research. However, one third trusted healthcare professionals to decide which research studies to inform them of. CONCLUSION: Effective ways to support healthcare professionals approaching vulnerable populations about research are needed to ensure young people are empowered to make informed choices about research participation

Optimizing a Retention Strategy with Young People for BRIGHTLIGHT, a Longitudinal Cohort Study Examining the Value of Specialist Cancer Care for Young People

PURPOSE: To maximize retention of participants in a longitudinal cohort study, we sought to understand young peoples' views about barriers and facilitators to continuing study participation. METHODS: Ten young people with a previous cancer diagnosis aged 15-24 participated in a 1 day workshop. The workshop used participatory methodology consisting of three exercises as follows: role play/scene setting; force field analysis of research participation in small groups; and focus group discussion. A final prioritization exercise was administered individually after the workshop. RESULTS: Twenty-four barriers to maintaining participation were summarized in five themes as follows: life commitments; concerns specific to the study; emotional barriers; practical barriers; and other reasons. The top 3 specific barriers were as follows: not a priority/other things are more important; too time consuming; and forgetting/memory. The top 3 facilitators for participation were as follows: wishing to help other young people; giving back to the cancer community; and honoring an initial commitment to participation. The top 3 suggested solutions to encourage continued participation were as follows: reminder text message or email before each survey to check preferred method of delivery; breaking up the online survey into modules to make completion less overwhelming; and consolidation of study information in one location. CONCLUSION: Involving young people in designing a retention strategy for young people with cancer has informed the BRIGHTLIGHT retention strategy. Patient and public involvement is imperative for successful research but measuring impact is challenging. The success of implementing the changes to optimize retention was shown in the increase in retention in Wave 3 from 30% to final participation of 58%

Young people's opinions of cancer care in England: the BRIGHTLIGHT cohort

OBJECTIVES: The BRIGHTLIGHT cohort study was the national evaluation of cancer services for teenager and young adults (TYA). This was analysis of free-text survey data to better understand their experiences of cancer care. DESIGN: Cohort study SETTING: National Health Service hospitals delivering cancer care in England PARTICIPANTS: 830 young people newly diagnosed with cancer. INTERVENTIONS: Exposure to specialist care in the first 6 months after diagnosis defined as care in a TYA Principal Treatment Centre (PTC). This was categorised as follows: all care in a TYA-PTC (ALL-TYA-PTC), no care in a TYA-PTC (NO-TYA-PTC) so care delivered in a children/adult unit only and some care in a TYA-PTC with additional care in a children's/adult unit (SOME-TYA-PTC). PRIMARY OUTCOME: Data were collected through the BRIGHTLIGHT survey included free-text questions which asked patients 'what was the best aspects of their experiences of care' and 'what aspects could be improved'. These comments were analysed using content analysis. Themes were compared between categories of care, then ranked in order of frequency, ranging from the most endorsed to the least. RESULTS: Overall, young people were most positive about their healthcare team, while the area highlighted for improvement was diagnostic experience. Differences between the three groups suggested those who had some or all treatment in a TYA-PTC valued the place of care. Regardless of where TYA were treated their healthcare teams were favourably viewed. Age appropriate place of care was highlighted to be of value for those in PTCs. CONCLUSIONS: These data show the value young people placed on the care they received in TYA specific wards. Young people who accessed some or all of their care in a TYA-PTC highly endorsed their place of care as one of the best elements of their care, and it is further emphasised by those who had shared care who experienced difficulty with lack of age-appropriate care when treated outside the TYA-PTC

Multi-Professional Perspectives on Adolescent and Young Adult Oncology Across Europe: An e-Delphi Survey

The aims of this article are to describe the ongoing development of adolescent and young adult (AYA) cancer services within the European Union (EU), and to develop consensus on key areas within the field. This survey used an e-Delphi design. An initial survey was distributed via email to professionals working in Europe. A snowball sampling technique was used to promote distribution. Consensus was sought over three rounds from October 2012 to April 2015. Consensus was defined as >80% agreement (“agree” or “strongly agree”). Sixty professionals participated in round 1, 106 in round 2, and 61 in round 3. Twenty-six countries were represented across all rounds. Consensus was achieved for: the need for national policy guidance, the importance of patient choice, the validity of the International Charter of Rights for Young People, and some aspects of multi-disciplinary working. There was 75% agreement on a single definition of the patient age range within AYA cancer care. European professionals with expertise in AYA cancer care reached consensus on key elements of care for this group. The optimal AYA age range remained an elusive topic on which to agree. The broad engagement and interest in AYA cancer across the EU through the European Network for Cancer in Children and Adolescents (ENCCA) network was also demonstrated

Being normal, not vulnerable: case study of a 2-day residential programme for young adults with cancer.

OBJECTIVES: To identify and describe the outcomes and facilitating processes of participation at 'Find Your Sense of Tumour' (FYSOT), a 2-day residential programme/conference for young people with cancer, from the perspective of professionals attending and patient representatives. DESIGN: Case study. SETTING: Observation of the 'Find Your Sense of Tumour' over 18s residential programme and face-to-face interviews in hospital and phone interviews. PARTICIPANTS: Twenty-six participants - 19 professionals from hospitals across the UK who accompanied young people to FYSOT; 3 programme organisers; and 4 young people from the programme steering committee. METHODS: Participant observation and semistructured interviews. RESULTS: This process evaluation of an educational, social and peer-to-peer support residential weekend for young people with cancer identified key outcomes for young people - positive attitudes (increased sociability, confidence), belonging (feeling accepted, understood), recreation (trying new activities, having fun) and increased knowledge (balance between educational talks and interactions with other young people); and three overarching facilitating processes - being with other young people, the professionals accompanying young people to the event for support and guidance, and the conference/intentional programming. Being in a safe, relaxed and fun environment with other young people facilitates the development of peer support networks and increases young people's confidence and knowledge. Although the focus of the residential programme is on young people, interviewees acknowledge the impact of attending on professionals' motivation, learning and changes in practice. CONCLUSIONS: This study has extended our understanding of the role of residential programmes by identifying outcomes and facilitating mechanisms. We have shown that residential programmes have an important role in providing participants with social, emotional and informational support, as well as play an important role in redefining normality. Longitudinal quantitative and qualitative research is needed to optimise outcomes and design and implement quality programmes that support young people's development

Sex, Body Image, and Relationships: A BRIGHTLIGHT Workshop on Information and Support Needs of Adolescents and Young Adults

PURPOSE: Discovering sexuality and romantic relationships are important development milestones in adolescence and young adulthood. A cancer diagnosis imposes obstacles for young people such as changes in their sexual function due to the disease and/or side effects of treatment, body image concerns, and interpersonal relationship difficulties. This can cause psychological distress and can impact on quality of life. We aimed to explore sexual health information and support needs of adolescents and young adults with cancer. METHODS: Five young people aged 16-24 years, with a previous cancer diagnosis when aged 13-22 years, attended an in-depth 4-hour workshop. The framework approach was used to analyze workshop transcripts. RESULTS: Three overarching themes emerged: (i) information sharing; (ii) contexts and relationships (influencing factors); and (iii) information sharing preferences. Information shared by healthcare professionals was focused on a medicalized view of sex with symptoms, infection control, and protected sex at its core. Young people had unanswered questions related to sexual function, the impact of cancer and how to manage it, and about pleasure, body image, and relationships. Parents' presence at clinical consultations inhibited discussions about sex. Young people wanted professionals who were comfortable to talk about sex with them. CONCLUSION: Young people exhibited significant unmet needs around information provision on sex, body image, and relationships. They wanted information to be given by professionals and access to online resources. Development of training for professionals and resources to support young people requires further work

Qualitative study to understand the barriers to recruiting young people with cancer to BRIGHTLIGHT: a national cohort study in England

Objectives: BRIGHTLIGHT is a national evaluation of cancer services for teenagers and young adults in England. Following challenges with recruitment, our aim was to understand more fully healthcare professionals’ perspectives of the challenges of recruiting young people to a low-risk observational study, and to provide guidance for future recruitment processes. / Design: Qualitative. / Setting: National Health Service (NHS) hospitals in England. / Methods: Semistructured telephone interviews with a convenience sample of 23 healthcare professionals. Participants included principal investigators/other staff recruiting into the BRIGHTLIGHT study. Data were analysed using framework analysis. / Results: The emergent themes were linked to levels of research organisational management, described using the levels of social network analysis: micro-level (the individual; in this case the target population to be recruited—young people with cancer); meso-level (the organisation; refers to place of recruitment and people responsible for recruitment); and macro-level (the large-scale or global structure; refers to the wider research function of the NHS and associated policies). Study-related issues occurred across all three levels, which were influenced by the context of the study. At the meso-level, professionals’ perceptions of young people and communication between professionals generated age/cancer type silos, resulting in recruitment of either children or adults, but not both by the same team, and only in the cancer type the recruiting professional was aligned to. At the macro-level the main barrier was discordant configuration of a research service with a clinical service. / Conclusions: This study has identified significant barriers to recruitment mainly at the meso-level and macro-level, which are more challenging for research teams to influence. We suggest that interconnected whole-system changes are required to facilitate the success of interventions designed to improve recruitment. Interventions targeted at study design/management and the micro-level only may be less successful. We offer solutions to be considered by those involved at all levels of research for this population

Involving young people in BRIGHTLIGHT from study inception to secondary data analysis: Insights from 10 years of user involvement

© The Author(s). Background Young people with cancer, broadly those aged 13–24 years at diagnosis, warrant special attention; physiological and psychological growth creates complex psychosocial needs which neither adult nor child systems are suitably designed to deal with. Resulting from these needs, they are often described as ‘vulnerable’, ‘hard to reach’ and ‘difficult to engage’, and consequently are often over looked for patient and public involvement/ engagement (PPIE) roles. In our study ‘BRIGHTLIGHT’, we set out to evaluate whether specialist care for young people adds value, ensuring young people were central to our PPIE activities. We believe that BRIGHTLIGHT is unique as a very large study of young people with cancer which has successfully overcome the challenges of including young people in the research process so we are confident that they have influenced every aspect of study design, conduct and dissemination. Methods We chronicle a period of 10 years, over which we describe our approach and our methods to involving young people in PPIE activities in BRIGHTLIGHT. We describe the feasibility work, study set up, conduct and dissemination of our findings, and weave through our story of PPIE to illustrate its benefits. Through the narration of our experience we highlight significant points that both influenced and changed our direction of travel. We reflect on our experiences and offer some practical advice for those looking to do the same. Results In the 10 years since the BRIGHTLIGHT feasibility work began we have involved more than 1200 young people. Their contributions have been isolated and mapped over a 10-year period. We begin at an early step of identifying what research questions to prioritize, we then plot PPIE activities for one of these research priorities, place of care, which evolved into BRIGHTLIGHT. We document steps along the way to evidence the impact of this involvement. Conclusions Young people can make a valuable contribution to healthcare research given adequate support from the research team. Although some challenges exist, we propose that the benefits to young people, researchers and the study considerably outweigh these challenges and PPIE with young people should be integrated in all similar research studies

Multi-pumping mechanised determination of selenium in natural waters by light emitting diode (LED) spectrometry

It has been developed a fully mechanised procedure for the determination of selenium in waters employing a LED based spectrometer and solenoid multi-pumps as solution propelling devices. The proposed method is based on the reaction of selenium with potassium iodide in an acidic medium to liberate iodine, which oxidizes Variamine Blue to form a violet-colour species which absorb at 530 nm. The system was mechanised using the multicommutation process and a stopped flow strategy in the final step reaction. The analytical curve was linear between 0.010 and 0.500 mg L-1, with an equation ΔA = 0.501 (± 0.004) C and r = 0.999. The limit of detection (3σ/S) obtained for the proposed method was 0.004 mg L-1. The relative standard deviation for Se solutions of 0.050 and 0.200 mg L-1 (n = 4) were 1.6 and 1.8% respectively, the sampling throughput was 23 determinations per hour, and accuracy was 95% probability level.Um procedimento para determinação de selênio em águas, completamente mecanizado, foi desenvolvido empregando um fotômetro baseado em LED e mini-bombas solenóide como dispositivos de propulsão. O método proposto é baseado na reação de selênio com iodeto de potássio em meio ácido para liberar iodo, o qual oxida a variamina azul formando um composto violeta que absorve em 530 nm. O sistema foi mecanizado empregando o processo de multicomutação em fluxo e uma estratégia de parada de fluxo na etapa final para desenvolvimento da reação. A curva analítica foi linear entre as concentrações de 0,010 a 0,500 mg L-1, segundo a equação ΔA = 0,501 (± 0,004) C (R = 0,999). O limite de detecção (3σ/S) obtido com o método proposto foi de 0,004 mg L-1. Desvios padrão relativo de 1,6 e 1,8% (n = 4) foram obtidos para soluções de Se com concentrações de 0,050 e 0,200 mg L-1, respectivamente. A freqüência de amostragem foi de 23 determinações por hora, e a exatidão foi de 95% de probabilidade.CAPES - MECDMinisterio de Educación y CienciaDirecció General d'Investigació i Transferència Tecnològica de la Generalitat ValencianaAcción Especial de la Universitat de Valenci