Participant Information Sheet Research Articles

Analysis of informed consent documents for compliance with ICMR guidelines for biomedical and health research

Abstract Background: Ethical conduct of research depends on the voluntary expression of consent and adequate disclosure of information about the research in informed consent documents (ICDs). Objectives: The objective of this study was to analyze ICDs of academic studies for compliance with National Ethical Guidelines for Biomedical and Health Research laid down by the Indian Council of Medical Research (ICMR) and to determine the readability of ICDs using the Flesch–Kincaid Grade Level scale and Flesch reading-ease (FRE) score. Methodology: ICDs of academic research projects submitted during 2020–22 were retrieved from the IEC office and analyzed for compliance with ICMR 2017 guidelines. The readability of the documents was assessed by the Flesch–Kincaid Grade Level Scale and FRE score. Results: Among 177 protocols analyzed, the most common were epidemiological studies (36.72%), followed by diagnostic studies (28.81%). Vernacular translations of ICDs were present in significantly more studies in 2022 (χ 2 = 7.18, P = 0.02) as compared to 2020 and 2021. FREs score was 45.75 ± 10.76, and Flesch–Kincaid Grade Level was 8.67 ± 1.44. Content analysis of participant information sheet (PIS) revealed that significantly more PIS submitted in 2022 mentioned expected duration of participation (χ 2 = 6.95, P < 0.001), benefit to patient/community (χ 2 = 26.63, P < 0.001), disclosure of foreseeable risk or discomfort (χ 2 = 21.72, P < 0.001), payment for participation (χ 2 = 21.72, P < 0.001), and identity of research team and contact details (χ 2 = 18.58, P < 0.001). Compliance score was significantly better in 2022 as compared to 2020 and 2021. Conclusion: Gradually, ICDs became more compliant with ICMR guidelines. Still, there is scope for improvement in ICDs regarding content and readability so that patients can comprehend facts easily to make informed decisions in a real sense.

National survey on understanding nursing academics' perspectives on digital health education.

This study explored the knowledge and confidence levels of nursing academics in teaching both the theories and practical skills of digital health in undergraduate nursing programs. A cross-sectional study. A structured online survey was distributed among nursing academics across Australian universities. The survey included two sections: (1) the participants' demographics and their nursing and digital health teaching experience; (2) likert scales asking the participants to rate their knowledge and confidence to teach the theories and practical skills of four main themes; digital health technologies, information exchange, quality and digital professionalism. One hundred and nineteen nursing academics completed part one, and 97 individuals completed part two of the survey. Only 6% (n = 5) of the participants reported having formal training in digital health. Digital health was mainly taught as a module (n = 57, 45.9%), and assessments of theory or practical application of digital health in the nursing curriculum were uncommon, with 79 (69.9%) responding that there was no digital health assessment in their entry to practice nursing programs. Among the four core digital health themes, the participants rated high on knowledge of digital professionalism (22.4% significant knowledge vs. 5.9% no knowledge) but low on information exchange (30% significant knowledge vs. 28.3% no knowledge). Statistically significant (p < .001) associations were found between different themes of digital health knowledge and the level of confidence in teaching its application. Nursing academics with more than 15 years of teaching experience had a significantly higher level of knowledge and confidence in teaching digital health content compared with those with fewer years of teaching experience. There is a significant gap in nursing academics' knowledge and confidence to teach digital health theory and its application in nursing. Nursing academics need to upskill in digital health to prepare the future workforce to be capable in digitally enabled health care settings. Nursing academics have a limited level of digital knowledge and confidence in preparing future nurses to work in increasingly technology-driven health care environments. Addressing this competency gap and providing sufficient support for nursing academics in this regard is essential. What problem did the study address? Level of knowledge and confidence among nursing academics to teach digital health in nursing practice. What were the main findings? There is a significant gap in nursing academics' knowledge and confidence to teach digital health theory and its application in nursing. Where and on whom will the research have an impact? Professional nursing education globally. The STROBE guideline was used to guide the reporting of the study. The call for participation from nursing academics across Australia provided an introductory statement about the project, its aim and scope, and the contact information of the principal researcher. A participant information sheet was shared with the call providing a detailed explanation of participation. Nursing academics across Australia participated in the survey through the link embedded in the participation invite.

Experiences of caring for women with cervical cancer: A qualitative study among male partners in Dar es Salaam, Tanzania.

More than three-fourths of cervical cancer cases occur in low- and middle-income countries, with sub-Saharan Africa (SSA) accounting for approximately 25% of global mortality. The significant rise in the prevalence of cervical cancer in SSA amplifies the burden on caregivers, contributing to elevated rates of mental illness, particularly among spouses who provide care. Men who assume the role of caregivers for their partners with cervical cancer encounter unique challenges and substantial adjustments across multiple facets of life, impacting both their own quality of life and that of their partners. Despite this, there is a notable lack of extensive research on the experiences of male partners in caregiving roles, particularly within SSA countries like Tanzania. Therefore, this study aimed to explore the experiences of male partners providing care for women with cervical cancer in Dar es Salaam, Tanzania. An exploratory qualitative study was undertaken to explore the experiences of 13 male partners, selected purposively and guided by the principle of saturation. Data gathering employed in-depth interviews utilizing a semistructured interview guide, with subsequent analysis conducted via a thematic analysis approach. Five themes and 13 subthemes were generated, encompassing psychosocial distress, attitudes towards cervical cancer, unity in the provision of care, economic burden, and altered sexual relationships. Participants reported experiencing emotional distress, shifts in social responsibilities, financial challenges, and unfulfilled sexual needs. Moreover, they expressed the need for social, psychological, financial, and sexual and reproductive support. This study underscores the numerous challenges encountered by male partners caring for women with cervical cancer, encompassing emotional distress, financial strain, and shifts in social and sexual dynamics. The identified themes and subthemes highlight the intricate interplay of these difficulties and stress the necessity for holistic support systems addressing the social, psychological, financial, and sexual aspects of male partners' experiences. The findings emphasize the importance of designing and implementing comprehensive support programmes tailored to the diverse needs of male partners, ultimately enhancing their quality of life and overall well-being. Before the study, the nursing manager assisted in selecting three male partners randomly. These partners were involved in the design of the participants' information sheet, the evaluation of the interview schedule and rooms, and the dissemination of information about the study's purpose to the target population. Their valuable input contributed to improving the participant information sheet, refining data collection procedures and addressing ethical considerations. However, these individuals were not considered study participants. Throughout the study, in-charge nurses in the hospital were informed about the study's goals and helped organize appointments with participants and manage the interview schedule.

Refractive Error Awareness among School Teachers in Tirukalukundram, Chengalpattu District- A Questionnaire based Study

Aim: To determine Refractive error awareness among School Teachers and to analyse Educational Qualification of School Teachers is in association with Refractive error Awareness. Setting and Design: Cross Sectional Study design with online questionnaire based survey performed from June 2022 to August 2022. Materials and Methods: 460 School Teachers of 22 Schools participated in this study. Validated questionnaire was distributed in English and Tamil Format through WhatsApp as Google Form. Referral letter regarding the project was given to District Educational Officer, Chief Educational Officer, Assistant Educational Officer, and Headmaster. Participant Information sheet and Informed consent was given to School Teachers. Data was calculated based on median score. Normality testing was done. Statistical analysis SPSS and MS EXCEL was used and Chi-square test was done to determine association between Educational qualification and Refractive error awareness. Result: 460 participants responded to the Questionnaire with mean age group (36.76 ± 8.67) years and mean Teaching Experience group (21.70 ± 0.65) years School Teachers participated in this study 387(84%) Female and 73(16%) Male. Chi Square test was done to determine association on Educational qualification with Knowledge (X2=1.981 p value=0.159) and Attitude (X2=1.077, p value=0.299), and also to determine association with Gender on Knowledge (X2=19.769, p value=0.011) and Attitude (X2=9.171, p value=0.328). Conclusion: This present study concludes that awareness does not depend on Educational qualification, since awareness level is less and steps need to be taken to prevent visual impairment.

Uncovering communication strategies used in language‐discordant consultations with people who are migrants: Qualitative interviews with healthcare providers

AbstractBackgroundGlobal migration has led to a sharp increase in the number of language‐discordant consultations (LDCs) in healthcare. Evidence on how healthcare providers (HCPs) meet migrant patients' needs while mitigating language barriers is lacking.DesignUsing purposive and snowball sampling, we recruited twenty‐seven Dutch HCPs (Mage = 45.07, SD = 11.46) and conducted semi‐structured interviews to collect qualitative, open‐ended data for identifying the communication strategies used with migrant patients in LDCs. We analysed the transcripts using deductive and inductive approaches (e.g., constant comparative method from Grounded Theory). Final pattern codes (i.e., key themes) were discussed among the research team until mutual agreement had been achieved.ResultsFive key themes emerged from the analyses: HCPs often ‘got‐by’ with (1) instrumental and (2) affective communication strategies used in language‐concordant consultations to start medical consultations. When some instrumental communication strategies were deemed ineffective (e.g., lingua franca, gesturing, etc.) to bridge language barriers, HCPs turned to (3) incorporating digital tools (e.g., Google Translate). When HCPs were unable to communicate with migrant patients at all, (4) informal, ad‐hoc and professional interpreters were involved. Finally, HCPs often (5) involved additional support to engage migrant patients to engage in treatment‐related behaviours.Discussion and ConclusionsOur results highlight the importance of raising awareness among HCPs about using various combinations of different strategies. The development of a guideline indicating the optimal combination of communication strategies for different medical consultation goals may be useful in reshaping the current communication behaviour of HCPs in LDCs.Patient or Public ContributionHCPs were the study population involved in this qualitative study. Refugee health advisors, general practitioners and linguistic specialists (i.e., members of the Right2Health consortium) with experience with the Dutch healthcare system were involved throughout the development of this research. This includes a review of the research question, participant information sheet and interview topic guide as well as providing interpretations of the data and feedback to this manuscript.

Use of visual aids for improving communication between researchers and research participants living with dementia

AbstractBackgroundResearch shows that pictures enhance the comprehensibility of written information. To ensure vulnerable groups are protected, ethical conduct of research requires collection of informed consent, ensuring research participants have a clear understanding of the research topic. For complex research, consent forms and participant information sheets can be lengthy, text‐heavy, and difficult to interpret, creating comprehension difficulties. For people living with dementia and associated cognitive impairment, such difficulties are magnified. The purpose of our study was to assess the preferences of people with dementia for written or pictorial information when providing informed consent.MethodA consent process was undertaken as part of a broader research design involving people living with dementia and their care‐partners in focus groups and online interviews. Consent was obtained at the beginning of each session, providing a choice between written and pictorial research information, i.e., consent form and participant information sheet. Text‐based research information was summarized into short sentences. Simplistic illustrations were created based on those sentences which acted as descriptions of the visuals (see Image 1 and Image 2). Both text and picture‐based versions were shared with research participants when first recruited for completion and collection at the focus group or interview. Preference was ascertained by noting the choice of format.Focus groups were conducted in person in Wynnum Library, Brisbane and interviews were conducted online.ResultThree people living with dementia and three care‐partners participated in focus groups. Four people living with dementia and two care‐partners participated in online interviews.All people living with dementia demonstrated a preference for the picture‐based versions, while care‐partners had mixed responses. All participants felt that the multimodal approach was considerate of the needs of people living with dementia.ConclusionOur findings suggest the majority of people living with dementia would prefer research information documents in a multimodal format, although the finding is not generalizable due to a small sample size. Whether this preference is due to its visual appeal or its ability to simplify the information is unclear and warrants further investigation. Larger studies may improve generalizability to broader populations.

Ethical considerations for participatory action research involving people with potential cognitive impairment

AbstractBackgroundThis case study aims to stimulate discussion around ethics approvals for research involving humans that is classified as high‐risk. Emerging research paradigms like participatory action research (PAR) advocate for the inclusion of stakeholders in research design, conduct, and analysis, but ethics approval requires development of the research and analysis plan prior to submission of the application, and approval is needed for all research materials, including consent forms, participant information sheets, and recruiting and marketing materials. How is it then possible to involve consumers in the research design and development phase prior to ethical approval of consent documentation?MethodThis investigation is part of the overall analysis of the COM‐IC SRG (Core Outcome Measures for Improving Care in Dementia Stakeholder Reference Group), the consumer arm of the COM‐IC study. It is a case study investigating the ethical approval process for participatory action research involving people with potential cognitive impairment. Data is sourced through the activities of the COM‐IC investigation team and the subsidiary interim SRG, as well as their communication and interaction with HREC teams from supporting institutions. Documentation pertaining to and reflections on the ethics approval process for the stakeholder reference group are critically analysed within the context and purpose of ethical review.ResultAnalysis of the ethics approval process suggests a paradigm shift is needed if true participatory action research is the goal. Lengthy delays, inconsistencies in panel decisions, poor communication, and different perceptions of rights and capabilities of people labelled high‐risk complicates an already highly emotive process. That said, it remains critical to the integrity of the overall system to have checks and balances against unethical research and ensure the rights of participants are truly protected.ConclusionIt is important for people with cognitive impairment to have the opportunity to contribute to research that is about them. Current ethical approval processes, while advocating for protection of vulnerable groups, are inadvertently impeding and complicating their capacity to be involved. Moving forward requires a collaborative rethink around ways of working that both protect and enhance opportunities for people with cognitive impairment.

Exploring community pharmacists’ views around HRT and the menopause

Abstract Introduction The number of women in England prescribed HRT has increased dramatically in the last seven years.1 Meanwhile, from 2018, HRT product shortages have resulted in the release of Serious Shortage Protocols allowing community pharmacists to supply alternative HRT products where appropriate.2 Furthermore, in 2022, the first over-the-counter medication for vaginal atrophy in menopause was licensed.3 With so many recent changes, it seemed an opportune time to determine community pharmacists’ views on the topic. Aim The aim of this study was to explore community pharmacists’ views around HRT and the menopause. Methods A qualitative approach using semi-structured interviews was chosen to allow for exploration of views. A list of community pharmacies from Stoke-on-Trent and Staffordshire was obtained from the NHS website. They were grouped into independent and multiple pharmacies in both urban and rural areas. Twenty pharmacies were then randomly selected from across the lists, emailed and invited to participate in the study; a participant information sheet and consent form was attached. This was followed up with a telephone call one week later, and a day and time for interview was agreed. Telephone interviews were undertaken, with consent obtained verbally, and the interview digitally recorded. The interview guide was developed based on the literature review and aim of the study. The guide addressed experiences of patient queries regarding HRT and the menopause, views of the OTC vaginal tablet and their confidence in discussing menopause with patients. Interviews were transcribed verbatim and thematically analysed. Ethical approval was obtained from Keele School of Pharmacy and Bioengineering Ethics Committee. Results Nine interviews were undertaken in October 2022, lasting 10 to 15 minutes. Five interviewees were male, five from urban areas, all from different companies and experience ranged from 3 months to 45 years. Four themes emerged from the transcripts, namely: increase in queries; managing shortages; lack of knowledge on Gina®; and limited professional interest in the topic. Patients were found to rarely ask about menopausal symptoms, with most queries related to risks associated with HRT or advice on various formulations. All pharmacists found dealing with shortages to be time-consuming and potentially stressful. Many of the pharmacists had not heard of the new vaginal tablet and did not stock it. Those who did, felt it was expensive and unlikely to sell. All stated they would like further training on the menopause but only one would consider specialising as a future area of prescribing. Discussion/Conclusion This was a small study with relatively short interviews, due to the time constraints facing working pharmacists. Despite this, similarity in responses suggest that data saturation may have been reached. This study confirms previous reports of increasing queries relating to HRT, particularly around shortages, and the stress associated with dealing with them. The pharmacists stated they would like further training on the topic, although CPPE packages on menopause are available. Despite the increased attention and prescribing of HRT, there was little desire to specialise and prescribe in this area; this should be explored further.

Community pharmacists' perceptions of the POM to P reclassification of medicines for sexual and reproductive health – A survey study

Abstract Introduction In the UK, medicines reclassification is the process of changing the legal classification of a medication, such as from a prescription-only medicine (POM) to a pharmacy (P) or general sales list (GSL) medicine.1 It is overseen by the Medicines and Healthcare products Regulatory Agency (MHRA). and improves patient access to certain medications while ensuring safeguards are in place for their safe and responsible use.2 A number of the most recent POM to P reclassifications have been for medications used in sexual and reproductive healthcare. Aim To investigate community pharmacists' (CPs’) perceptions of POM to P medicine reclassifications for sexual and reproductive health: sildenafil citrate (Viagra Connect, for erectile dysfunction), desogestrel (Hana/Lovima, for contraception), and estradiol hemihydrate (Gina, for vaginal atrophy). Methods The study population was all CPs in Greater London. The survey consisted of 59-questions in five sections. The first section was for general perceptions about the reclassification of medicines, while the other sections were specific to the medicines studied. The final section was demographics. Question types included multiple-choice, 5-point Likert scale, and free text. The recommended sample size was 340 (95% CI), therefore, 398 CPs, in 210 pharmacies, were approached. Ethical approval was obtained from the university ethics committee. Participants were posted a participant information sheet (PIS) one week before distribution of the survey as a hard copy. The survey was also available on Microsoft Forms. Data were analysed in Microsoft Excel and Statistical Package for Social Sciences (SPSS). Descriptive statistics were given in numbers and percentages. Results The response rate was 37.7% (N=150/398). Most CPs (88%) perceived that medication reclassification increased their role and provided greater access to medicines for the public. However, less than half (44%) had a good understanding of the reclassification process. Sildenafil was available to purchase in all of the visited pharmacies, however, desogestrel was only sold in 50% of them, and estradiol was sold in only 28%. Reasons cited for not selling desogestrel and/or estradiol included lack of public awareness about the availability of these products, and a lack of public interest in purchasing them. While the availability of sildenafil as a P medicine was seen as a positive for improving safe access, many CPs (86%) expressed concerns about the high risk of its misuse. In terms of training, the available training for sildenafil received higher ratings compared to that for desogestrel or estradiol. Most CPs (67%) indicated that having case studies incorporated into the training for POM to P switches helped them understand which patients could safely purchase these medications. Discussion/Conclusion CPs are positive about the availability of sexual and reproductive health medications over the counter. They do have concerns, however, about the potential of some of these medications to be misused, and also feel that more awareness of the availability of these products needs to be raised. Those producing training materials for reclassified medications should incorporate case studies as these support CP decision making. A limitation of this study was that the recommended sample size was not achieved.

Working with care leavers and young people still in care: ethical issues in the co-development of a participatory recordkeeping app

An important element of social research is the ethical treatment of research participants. This paper outlines the ethical issues pertaining to a study (MIRRA: Memory-Identity-Rights in Records-Access) that developed a ‘participatory recordkeeping system specification’ for young people in care. The research team worked with members of the cohort themselves (aged 13–17 years) and care-experienced adults. It discusses in general terms the various elements that require ethical consideration, such as informed consent, anonymity, avoiding harm, and needing to benefit the participants and their peers. It goes on to describe how such issues were approached by the team. The particular ethical measures required for the young and ‘cared-for’ participants are explored. These included the need to work through, first, an adult gatekeeper—a representative of each care organisation approached—and then, within the organisation, a social worker or care-giver. This greatly limited recruitment, as these adults often vetoed contact with the young people themselves. A checklist is outlined, derived from the ‘Gillick Test of Competence’ to assess capacity to give ‘informed consent’, for willing gatekeepers/carers to consider. The article then addresses how the Participant Information Sheets were developed for the young cohort, emphasising the need to do this by consulting appropriate professionals, published guidelines and the potential participants themselves. After considering the possible risks and benefits to participants, the paper concludes by suggesting that ethical issues around recruitment and participation of this cohort are complex and require much additional bureaucracy, patience and flexibility—but can be immensely rewarding.

Evaluating a Smartphone App (MeT4VeT) to Support the Mental Health of UK Armed Forces Veterans: Feasibility Randomized Controlled Trial.

Previous research demonstrates that less than 50% of military veterans experiencing mental health difficulties seek formal support. Veterans often struggle to identify problems as mental health difficulties. In addition, they may fail to recognize the need for support before reaching a crisis point and face difficulties navigating care pathways to access support. A feasibility trial was conducted to assess a novel digital smartphone app (Mental Health Toolkit for Veterans Project [MeT4VeT]) for UK Armed Forces (UKAF) veterans experiencing mental health difficulties. The trial aimed to explore the feasibility and acceptability of trial procedures for a later randomized controlled trial (RCT) and to assess the acceptability of the MeT4VeT app. Participants were recruited at UK military medical centers, by advertising on social media, and through veteran third-sector organizations between February and November 2021, and assessed for eligibility (male, owned a smartphone, served at least 2 years in the UKAF, left the UKAF within the last 2 years, not undertaking formal mental health treatment). Eligible participants were assigned, on a 1:1 ratio, to either the intervention group (full app) or a control group (noninteractive app with signposting information). Three key objectives were determined a priori to assess the practicality of running an RCT including an assessment of recruitment and retention, evaluation of the technical app delivery and measurement processes, and acceptability and usability of the intervention. In total, 791 individuals completed the participant information sheet, of which 261 (33%) were ineligible, 377 (48%) declined or were unable to be contacted for consent, and 103 (13%) did not download the app or complete the baseline measures. Of this, 50 participants completed baseline measures and were randomly assigned to the intervention group (n=24) or the control group (n=26). The trial was effective at enabling both the technical delivery of the intervention and collection of outcome measures, with improvements in mental health demonstrated for the intervention group from baseline to the 3-month follow-up. Recruitment and retention challenges were highlighted with only 50 out of the 530 eligible participants enrolled in the trial. The acceptability and usability of the MeT4VeT app were generally supported, and it was reported to be a useful, accessible way for veterans to monitor and manage their mental health. The results highlighted that further work is needed to refine recruitment processes and maintain engagement with the app. Following this, an RCT can be considered to robustly assess the ability of the app to positively affect mental health outcomes indicated within this trial. ClinicalTrials.gov NCT05993676; https://clinicaltrials.gov/ct2/show/NCT05993676.

Knowledge, attitudes, and practices associated with vitamin D supplementation: A cross-sectional online community survey of adults in the UK.

Assess knowledge, attitudes, and practices (KAPs) of a diverse population. Identify barriers and facilitators that inform routine vitamin D supplementation and self-care in the community setting. Cross-sectional online voluntary survey. Electronic survey link published on college Qualtrics platform and advertised widely. Study information provided with Participant Information Sheet. 556 community dwelling adults across the UK. The overarching study included two phases, incorporating quantitative and qualitative methodologies. This paper reports findings from the first phase of the FABCOM-D (Facilitators and Barriers to Community (Healthy) Vitamin D status) study. Online survey questions were iteratively developed after background literature searches and piloted to ensure clarity and ease of understanding. Survey responses summarised using frequencies and percentages, and univariable and multivariable logistic regression models explored for any association. A p-value less than 0.05 was considered statistically significant. The Checklist for Reporting Results of Internet E-Surveys guided reporting. Statistical analysis performed using IBM SPSS software. Awareness of vitamin D information sources, health benefits and testing. Attitudes to supplementation, sun exposure and fortification. Three quarters of the community had some awareness of vitamin D and around half were taking supplements. The two most trusted sources of information included health professionals and the NHS website. Participants were willing to pay for supplements, supporting a self-care agenda. With increasing age, there was significant reduced intake of vitamin D supplements. This aspect needs to be explored further as this could be a concern in deficiency status in the elderly. There was acceptance of food fortification but uncertainty on how to balance food intake with supplementation. We were successful in eliciting views on KAPs around vitamin D from a community population including a large proportion of Black and Minority Ethnic individuals. The community wanted information and guidance to help manage individual vitamin D status, especially for high-risk groups, and on balancing supplementation, food fortification and sun exposure.

Family carers' experiences and perceived roles in interprofessional collaborative practice in primary care: A constructivist grounded theory study.

Chronic conditions can lead to physical, cognitive and social decline; thus, increasing an individual's dependence on family who assist with activities of daily living. Interprofessional collaborative practice (IPCP), involving two or more health professionals working with the patient and their family, is one model of care for the high-quality management of individuals with chronic conditions in primary care. Nevertheless, family carers have reported a disconnect between themselves and healthcare providers in previous research. This study aimed to explore the experiences and perspectives of family carers for individuals with chronic conditions, regarding their involvement in IPCP. Aspects of constructivist grounded theory methodology were used. Family carers of individuals with chronic conditions were invited to participate in a one-on-one, semistructured interview about their experiences with IPCP in the care of their loved one. Interview transcripts were analysed using Charmaz's four-step iterative process: (1) line-by-line coding, (2) focused coding, (3) categorisation of codes and (4) potential theme and subtheme development with memo writing to support each phase of analysis. The research team collaborated on reflexivity exercises, the conceptualisation of categories and the development of themes. Constructivist data analysis of interviews (average 40 min) with 10 family carers resulted in two themes. (1) Stepping in for my loved one represents the notion that carers take on external roles on behalf of their loved ones (subthemes: working with interprofessional teams, supporting independence and learning as I go). (2) Taking on the carer role, represents the internal factors that influence the external roles described in theme 1 (subthemes: feeling obligated to be involved and changing relationship dynamics). This study outlines the external actions and internal influences on family carer involvement in an interprofessional team. The required knowledge and support to care for their loved ones is currently learned in an ad hoc manner, and carers' resources should be better promoted by health professionals. Additionally, the relationship dynamics between a carer and their loved one change as the carer becomes more involved in IPCP and influences how and the extent health professionals involve family carers. Carers were the study population involved in this qualitative study. Patient advocates who have chronic conditions, and are informal family carers, were involved in the creation and design of this study, including a review of the research question, participant information sheet and the interview guide.

ÖZEL YETENEKLİ ÖĞRENCİLERİN DİJİTAL OKURYAZARLIK ve SİBERAYLAKLIK DÜZEYLERİ ARASINDAKİ İLİŞKİNİN İNCELENMESİ

The purpose of this study is to investigate the levels of cyberloafing and digital literacy that are present among gifted secondary school students and to find the correlation between these two factors. The correlational screening model was used in this study. Participants were 179 secondary school (5th, 6th, 7th, and 8th grade) students enrolled in Science and Art Centers (SAC), who were identified as gifted in one or more fields. The participant information sheet, the Digital Literacy Scale and the Smartphone Cyberloafing Scale were used for the data collection. Data analysis was performed using SPSS 22 software. The mean scores were determined in order to gain an understanding of the levels of cyberloafing and digital literacy as shown by gifted students. The Pearson correlation test was used to investigate the association between digital literacy levels and cyberloafing levels of gifted students. The results showed that gifted students have high levels of digital literacy and low levels of cyberloafing. Pearson’s correlation test results reveal that there was no significant relationship between gifted students' digital literacy levels and cyberloafing levels (p&gt;.05, r= -.084). It is recommended to explore the factors influencing the cyberloafing levels of gifted students, as well as to analyze the cyberloafing and digital literacy of gifted students with different and larger samples, backed by qualitative studies in various age groups.

The impact of expert by experience involvement in teaching in a DClinPsych programme; for trainees and experts by experience.

There is a growing acknowledgement of the value of creating partnerships between those delivering and those accessing health services. Less is known about this in the context of clinical psychology doctoral training programmes. This study explores the models of involvement of experts by experience (EbEs) in teaching on a DClinPsych course in England; the impact of this both for EbEs and trainee clinical psychologists and whether improvements are required to better meet their needs. An audit of current involvement was conducted by reviewing course records. Two survey questionnaires designed around commonly used frameworks of participation and reflective learning were completed by EbEs and trainees. Thematic Analysis was used to evaluate the written feedback from the surveys. Records of current EbE involvement were found to be lacking in detail and sometimes missing. Key themes extrapolated from the surveys highlighted the importance of EbE involvement in supporting the wellbeing of EbEs and the learning experiences of trainees. Recommendations with regard to the processes for future involvement of EbEs in teaching are put forward. A carer of a service user was consulted about the design of the participant information sheet, consent form and the survey questionnaire which was sent to the EbEs. A trainee clinical psychologist was also consulted to provide a trainee perspective on the above forms and the survey questionnaire that was sent to trainees. Further to this, the first author's supervisor identifies as a user of physical and mental health services and provided continued supervision and support regarding the direction of the study including the research questions, design, methodology and interpretation of results.

Providing multimedia information to children and young people increases recruitment to trials: pre-planned meta-analysis of SWATs

BackgroundRandomised controlled trials are often beset by problems with poor recruitment and retention. Information to support decisions on trial participation is usually provided as printed participant information sheets (PIS), which are often long, technical, and unappealing. Multimedia information (MMI), including animations and videos, may be a valuable alternative or complement to a PIS. The Trials Engagement in Children and Adolescents (TRECA) study compared MMI to PIS to investigate the effects on participant recruitment, retention, and quality of decision-making.MethodsWe undertook six SWATs (Study Within A Trial) within a series of host trials recruiting children and young people. Potential participants in the host trials were randomly allocated to receive MMI-only, PIS-only, or combined MMI + PIS. We recorded the rates of recruitment and retention (varying between 6 and 26 weeks post-randomisation) in each host trial. Potential participants approached about each host trial were asked to complete a nine-item Decision-Making Questionnaire (DMQ) to indicate their evaluation of the information and their reasons for participation/non-participation. Odds ratios were calculated and combined in a meta-analysis.ResultsData from 3/6 SWATs for which it was possible were combined in a meta-analysis (n = 1758). Potential participants allocated to MMI-only were more likely to be recruited to the host trial than those allocated to PIS-only (OR 1.54; 95% CI 1.05, 2.28; p = 0.03). Those allocated to combined MMI + PIS compared to PIS-only were no more likely to be recruited to the host trial (OR = 0.89; 95% CI 0.53, 1.50; p = 0.67). Providing MMI rather than PIS did not impact on DMQ scores. Once children and young people had been recruited to host trials, their trial retention rates did not differ according to intervention allocation.ConclusionsProviding MMI-only increased the trial recruitment rate compared to PIS-only but did not affect DMQ scores. Combined MMI + PIS instead of PIS had no effect on recruitment or retention. MMIs are a useful tool for trial recruitment in children and young people, and they could reduce trial recruitment periods.

Parents' and adolescents' perspectives and understanding of information about childhood cancer precision medicine.

Precision medicine is projected to become integral to childhood cancer care. As such, it is essential to support families to understand what precision medicine entails. A total of 182 parents and 23 adolescent patients participating in Precision Medicine for Children with Cancer (PRISM), an Australian precision medicine clinical trial for high-risk childhood cancer, completed questionnaires after study enrollment (time 0 [T0]). Of the parents, 108 completed a questionnaire and 45 completed an interview following return of precision medicine results (time 1 [T1]). We analyzed the mixed-methods data comprising measures exploring families' perceptions and understanding of PRISM's participant information sheet and consent form (PISCF), and factors associated with understanding. Most parents were satisfied with the PISCF, rating it as at least "somewhat" clearly presented (n=160/175; 91%) and informative (n=158/175; 90%). Many suggested improvements including the use of clearer language and a more visually engaging format. Parents' actual understanding of precision medicine was low on average, but scores improved between T0 and T1 (55.8/100-60.0/100; p=.012). Parents from culturally and/or linguistically diverse backgrounds (n=42/177; 25%) had lower actual understanding scores than those from a Western/European background whose first language was English (p=.010). There was little correlation between parents' perceived and actual understanding scores (p=.794; Pearson correlation -0.020; 95% CI, -0.169 to 0.116). Most adolescent patients read the PISCF either "briefly" or "not at all" (70%) and had a perceived understanding score of 63.6/100 on average. Our study revealed gaps in families' understanding of childhood cancer precision medicine. We highlighted areas for potential intervention such as through targeted information resources. Precision medicine is projected to become part of the standard of care for children with cancer. Precision medicine aims to give the right treatment to the right patient and involves several complex techniques, many of which may be challenging to understand. Our study analyzed questionnaire and interview data from parents and adolescent patients enrolled in an Australian precision medicine trial. Findings revealed gaps in families' understanding of childhood cancer precision medicine. Drawing on parents' suggestions and the literature, we make brief recommendations about improving information provision to families, such as through targeted information resources.

The relationship between emotional intelligence and organizational commitment among nurses working in governmental hospitals in Jordan

IntroductionNurses’ emotions and feelings in response to their environment and their ability to manage their emotions can significantly affect several aspects of their job. In Jordan, studies are still investigating whether emotional intelligence is significantly related to organizational commitment.AimTo investigate whether a significant relationship exists between emotional intelligence and organizational commitment among Jordanian nurses working in governmental hospitals in Jordan.MethodsThe study used a descriptive cross-sectional correlational design. A convenience sampling method was used to recruit participants working in governmental hospitals. A total of 200 nurses participated in the study. A participant information sheet developed by the researcher was used to obtain the participants’ socio-demographic characteristics, the Emotional Intelligence Scale (EIS) developed by Schutte and colleagues, and the Organizational Commitment Scale developed by Meyer and Allen were utilized for data collection.ResultsParticipants had high levels of emotional intelligence (M, SD = 122.3, 14.0) and moderate levels of organizational commitment (M, SD = 81.6, 15.7). Emotional intelligence had a significant, positive relationship with organizational commitment (r = 0.53, p < 0.01). Male nurses, widowed nurses, and nurses with higher postgraduate qualifications demonstrated significantly higher levels of emotional intelligence and organizational commitment than female nurses, single nurses, and nurses with undergraduate degrees (p < 0.05).ConclusionParticipants in the current study were highly emotionally intelligent and moderately committed to their organizations. Policies supporting the implementation of interventions to improve organizational commitment and maintain a high level of emotional intelligence should be developed and promoted by nurse managers and hospital administrators, as well as decision-makers should magnet the nurses with postgraduate degrees at clinical sites.

AN EVALUATION OF CORRELATION BETWEEN THE GONIAL ANGLE AND FREEWAY SPACE IN DENTATE INDIVIDUALS

The purpose of the present study is to establish a correlation between gonial angle and freeway space using lateral profile photographs in dentulous individuals. The study includes a total of 150 participants within the age range of 20 – 30 years, of which one twenty-five were females and twenty-five were males. No restrictions were imposed with regard to the presence of malocclusion. The participants were informed about the study through participant information sheet and signed consent was obtained. The  study showed a mild negative correlation between Freeway space and gonial angle, indicating that when gonial angle increases freeway space decreases in both class I and  class II participants. The study also showed that the freeway space was found to be more in Angle’s class II dentate participantsThe study concludes that there was a statistically significant difference between freeway space between Angle’s Class I and Class II malocclusion. The freeway space in individuals with Angle’s class II malocclusion was greater as compared to that with Angle’s class I malocclusion. The gonial angle was observed to be more acute in participants with Angle’s class II malocclusion as compared to that in participants with Angle’s class 1 malocclusion. Lateral profile photographs can be used as a tool to predict freeway space in patients with Angle’s class I malocclusion.

Content validity of the Scoliosis Research Society questionnaire (SRS-22r): A qualitative concept elicitation study.

Scoliosis Research Society-22 revised (SRS-22r) is the common questionnaire used to evaluate health related quality of life (HRQOL) for young people with adolescent idiopathic scoliosis (AIS). The aim of this study is to evaluate its content validity for this population. In-depth semi-structured interviews were conducted with a purposive sample of young people with AIS (Cobb angle ≥25˚, aged 10-18 years). Concept elicitation was used to evaluate the influence of AIS on participants' HRQOL. Participant information sheets and consent/assent forms were age relevant. Topic guide was informed by the SRS-22r and existing evidence. Interviews were audio and video recorded, transcribed verbatim, coded, and analysed using thematic analysis. Derived themes/codes were compared with SRS-22r contents (domains/items). Eleven participants (mean age 14.9 years [SD = 1.8]; 8 female) were recruited. The mean curve size was 47.5° [SD = 18°] and participants had been managed via different approaches. Four main themes emerged with associated subthemes: 1) Physical effects related to physical symptoms (back hurt, stiffness) and body asymmetry (uneven shoulders), 2) Activity-related effects showed impact on mobility (sitting for long periods), self-care (dressing), and school activities (focus during lessons), 3) Psychological effects revealed emotional (feel worried), mental (sleep quality), and body image effects (hide back from others), 4) Social effects (participation in school and leisure activities), and school, friends and mental health support. A weak association was found between items of the SRS-22r and the identified codes. The SRS-22r does not adequately capture important concepts that relate to HRQOL of adolescents with AIS. These findings support revision of the SRS-22r, or the development of a new patient reported outcome measure to evaluate HRQOL of adolescents with AIS.