The COVID-19 pandemic has imposed a wide variety of unprecedented challenges, many of which appear to be disproportionately affecting the mental health and well-being of young adults. While there is ...evidence to suggest university students experience high rates of mental health disorders, less is known about the specific impacts of the COVID-19 pandemic on student mental health and how they are coping with this stress. To address this gap, we conducted an online study among undergraduate students (
= 366) to examine the impact of the COVID-19 pandemic on academics, social isolation, and mental health, as well as the extent to which they have been implementing a variety of coping strategies. The pandemic had a more pronounced negative effect on female students' academics, social isolation, stress and mental health compared to male counterparts. Moreover, for females, frequent use of social media as a coping mechanism was associated with greater perceived negative impacts on their academic performance and stress levels, compared to males. However, frequent social media use related to similar negative mental health effects for both males and females. While male and female students both reported using substances to cope, for males the use of cannabis was associated with greater negative impacts on academic outcomes, stress and mental health compared to females. These findings highlight the need for adequate student support services across the post-secondary sector, and point to the importance of gender informed interventions to address the impacts of the COVID-19 pandemic.
Abstract Background Patients from socioeconomically disadvantaged backgrounds are underserved in randomised controlled trials, yet they experience a much greater burden of disease compared with ...patients from socioeconomically advantaged areas. It is crucial to make trials more inclusive to ensure that treatments and interventions are safe and effective in real-world contexts. Improving how information about trials is verbally communicated is an unexplored strategy to make trials more inclusive. This study examined how trials are communicated verbally, comparing consultations involving patients from the most and least socioeconomically disadvantaged areas. Methods Secondary qualitative analysis of 55 trial consultation transcripts from 41 patients, sampled from 3 qualitative studies embedded in their respective UK multi-site, cancer-related randomised controlled trials. Patients living in the most and least socioeconomically disadvantaged areas, defined using English Indices of Multiple Deprivation decile scores, were purposively sampled. Analysis was largely thematic and drew on the constant comparison method. Results Recruiters communicated clinical uncertainty in a similar way for patients living in different socioeconomic areas. Consultations with disadvantaged patients were, on average, half the duration of those with advantaged patients, and tended to involve recruiters providing less in-depth explanations of trial concepts, used phrasing that softened trial arm risks, and described trial processes (e.g. randomisation) using informal or metaphorical phrasing. Disadvantaged and advantaged patients differed in the concerns they expressed; disadvantaged patients voiced fewer concerns and asked fewer questions but were also less likely to be invited to do so by recruiters. Conclusion Interactions about trials unfolded in different ways between patients living in different socioeconomic areas, likely due to both patient- and recruiter-related factors. We present considerations for recruiters when discussing trials with patients from socioeconomically disadvantaged backgrounds, aimed at enhancing trial communication. Future research should examine disadvantaged patients’ and recruiters’ experiences of verbal trial communication to inform guidance that addresses the needs and preferences of underserved groups.
Abstract
Background
Understanding patient and health practitioner perspectives on clinical trials can inform opportunities to enhance trial conduct and design, and therefore patient experience. ...Patients with haematological cancers have faced additional risk and uncertainty during the pandemic but it is unclear how they and practitioners have experienced cancer trials during this period. In the context of a haemato-oncology trial (PETReA), we compared patient and practitioner views and experiences of PETReA before and during COVID-19.
Methods
Qualitative study embedded within PETReA. Semi-structured interviews (
N
=41) with patients and practitioners from 16 NHS sites before (
n
=17) and during the first wave of COVID-19 (
n
=24). Analysis drew on the framework approach.
Results
Practitioners acknowledged the need for the trial to continue during the pandemic but their treatment preferences altered, becoming more pronounced for patients who had a favourable response to induction treatment, while staying unchanged for patients with a less favourable response. Practitioners commented that COVID-19 meant the evidence base for the trial arms was lacking or mixed, but that it likely increased the risks of maintenance treatment for patients with a favourable response to induction treatment. While only one participant interviewed withdrew from PETReA during the pandemic, others said they would consider withdrawing if information that they were at increased risk of severe illness from COVID-19 became available. During COVID-19, patients described less frequent contact with the trial team, which left some feeling less clear about their trial pathway. However, several described having in-depth, collaborative discussions with practitioners about the risks and benefits of randomisation in the context of COVID-19. Patients valued these discussions and were reassured by the emphasis practitioners placed on patients being free to withdraw if circumstances changed, and this helped patients feel comfortable about continuing in PETReA.
Conclusions
The findings point to ways trial communication can support patients to feel comfortable about continuing in a trial during uncertain times, including adopting a more in-depth, collaborative exploration of the risks and benefits of trial arms with patients and emphasising voluntariness. The results are relevant to trialists recruiting patients who are clinically extremely vulnerable or are at increased risk of poor COVID-19 outcomes despite being vaccinated.
Introduction
Providing balanced information that emphasizes clinical equipoise (i.e., uncertainty regarding the relative merits of trial interventions) and exploring patient treatment preferences can ...improve informed consent and trial recruitment. Within a trial comparing adjuvant radiotherapy versus active monitoring following surgical resection for an atypical meningioma (ROAM/EORTC‐1308), we explored patterns in communication and reasons why health practitioners may find it challenging to convey equipoise and explore treatment preferences.
Materials and Methods
Qualitative study embedded within ROAM/EORTC‐1308. Data were collected on 40 patients and 18 practitioners from 13 U.K. sites, including audio recordings of 39 patients’ trial consultations, 23 patient interviews, and 18 practitioner interviews. Qualitative analysis drew on argumentation theory.
Results
Practitioners acknowledged the importance of the research question that the trial aimed to answer. However, they often demonstrated a lack of equipoise in consultations, particularly with eligible patients who practitioners believed to be susceptible to side effects (e.g., cognitive impairment) or inconvenienced by radiotherapy. Practitioners elicited but rarely explored patient treatment preferences, especially if a patient expressed an initial preference for active monitoring. Concerns about coercing patients, loss of practitioner agency, and time constraints influenced communication in ways that were loaded against trial participation.
Conclusions
We identified several challenges that practitioners face in conveying equipoise and exploring patient treatment preferences in oncology, and particularly neuro‐oncology, trials with distinct management pathways. The findings informed communication about ROAM/EORTC‐1308 and will be relevant to enhancing trial communication in future oncology trials. Qualitative studies embedded within trials can address difficulties with communication, thus improving informed consent and recruitment. ROAM/EORTC‐1308 RCT: ISRCTN71502099.
Implications for Practice
Oncology trials can be challenging to recruit to, especially those that compare treatment versus monitoring. Conveying clinical equipoise and exploring patient treatment preferences can enhance recruitment and patient understanding. This study focused on the challenges that practitioners encounter in trying to use such communication strategies and how practitioners may inadvertently impede patient recruitment and informed decision making. This article provides recommendations to support practitioners in balancing the content and presentation of trial management pathways. The results can inform training to optimize communication, especially for neuro‐oncology trials and trials comparing markedly different management pathways.
Recruitment of enough eligible patients to randomized controlled clinical trials can be challenging. Within the context of an active clinical trial, this study explored communication strategies, especially how practitioners conveyed equipoise, explored and responded to patient treatment preferences, and the challenges encountered.
Smoking cessation following lung cancer diagnosis has been found to improve several patient outcomes. Electronic cigarette (e-cigarette) use is now prevalent within Great Britain, however, use and ...practice among patients with lung cancer has not as yet been explored. The current study aims to explore e-cigarette use among patients and examine current practice among clinicians. The results have important implications for future policy and practice.
Members of The British Thoracic Oncology Group (BTOG) were contacted via several e-circulations (N = 2,009), requesting them to complete an online survey. Of these, 7.7 % (N = 154) completed the survey, which explored participant demographics and smoking history, perceptions of patient e-cigarette use, practitioner knowledge regarding sources of guidance pertaining to e-cigarettes, and practitioner advice.
Practitioners frequently observed e-cigarette use among patients with lung cancer. The majority of practitioners (81.4 %) reported responding to patient queries pertaining to e-cigarettes within the past year; however, far fewer (21.0 %) felt confident providing patients with e-cigarette advice. Practitioner confidence was found to differentiate by gender (p = 0.012) and employment speciality (p = 0.030), with nurses reporting particularly low levels of confidence in advising. The results also demonstrate extensive variability regarding the practitioner advice content.
The results demonstrate that patients refer to practitioners as a source of e-cigarette guidance, yet few practitioners feel confident advising. The absence of evidence-based guidance may have contributed towards the exhibited inconsistencies in practitioner advice. The findings highlight that training should be delivered to equip practitioners with the knowledge and confidence to advise patients effectively; this could subsequently improve smoking cessation rates and patient outcomes.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Recruiting patients to paediatric trials can be challenging, especially in trials that compare markedly different management pathways and are conducted in acute settings. We aimed to enhance informed ...consent and recruitment in the CONTRACT trial (CONservative TReatment of Appendicitis in Children a randomised controlled Trial; ISRCTN15830435) - a feasibility trial that compared non-operative treatment (antibiotics) versus appendicectomy for uncomplicated acute appendicitis.
Qualitative study embedded within CONTRACT and conducted across three UK children's hospitals. Data were transcribed audio-recordings of 85 CONTRACT recruitment consultations with 58 families; and semi-structured interviews with 35 health professionals and 28 families (34 parents, 14 children) invited to participate in CONTRACT. Data analysis drew on thematic approaches. Throughout CONTRACT, we used findings from the ongoing qualitative analysis to inform bespoke communication training for health professionals recruiting to CONTRACT. Before and after training we also examined qualitative changes in communication during consultations and quantitative changes in recruitment rates.
Bespoke communication training focussed on presenting the trial arms in a balanced way, emphasising clinical equipoise, exploring family treatment preferences and managing families' expectations about the trial's treatment pathways. Analysis of recruitment consultations indicated that health professionals' presentation of treatment arms became increasingly balanced following training, (e.g. avoiding imbalanced terminology) and recruitment rose from 38 to 62%. However, they remained reluctant to explore families' treatment preferences and respond with further information to balance these preferences. Analyses of interviews identified the time constraints of the urgent care setting, concerns about coercion, and reservations about exposing children to conversations about treatment risks as reasons for this reluctance. Interviews with families indicated the importance of clear explanations of trial treatment timings and sensitive communication of treatment allocation for both recruitment and retention.
Following bespoke training based on the qualitative analyses, health professionals presented CONTRACT to families in clearer and more balanced ways and this was associated with an increase in the recruitment rate. Despite training, health professionals remained reluctant to explore families' treatment preferences. We provide several recommendations to enhance communication, informed consent, recruitment and retention in future trials in urgent care settings.
ObjectiveTo establish the feasibility of a multicentre randomised controlled trial to assess the effectiveness and cost-effectiveness of a non-operative treatment pathway compared with appendicectomy ...in children with uncomplicated acute appendicitis.DesignFeasibility randomised controlled trial with embedded qualitative study to inform recruiter training to optimise recruitment and the design of a future definitive trial.SettingThree specialist paediatric surgery centres in the UK.PatientsChildren (aged 4–15 years) with a clinical diagnosis of uncomplicated acute appendicitis.InterventionsAppendicectomy or a non-operative treatment pathway (comprising broad-spectrum antibiotics and active observation).Main outcome measuresPrimary outcome measure was the proportion of eligible patients recruited. Secondary outcomes evaluated adherence to interventions, data collection during follow-up, safety of treatment pathways and clinical course.ResultsFifty per cent of eligible participants (95% CI 40 to 59) approached about the trial agreed to participate and were randomised. Repeated bespoke recruiter training was associated with an increase in recruitment rate over the course of the trial from 38% to 72%. There was high acceptance of randomisation, good patient and surgeon adherence to trial procedures and satisfactory completion of follow-up. Although more participants had perforated appendicitis than had been anticipated, treatment pathways were found to be safe and adverse event profiles acceptable.ConclusionRecruitment to a randomised controlled trial examining the effectiveness and cost-effectiveness of a non-operative treatment pathway compared with appendicectomy for the treatment of uncomplicated acute appendicitis in children is feasible.Trial registration numberISRCTN15830435.
Although non-operative treatment is known to be effective for the treatment of uncomplicated acute appendicitis in children, randomised trial data comparing important outcomes of non-operative ...treatment with those of appendicectomy are lacking.
The objectives were to ascertain the feasibility of conducting a multicentre randomised controlled trial comparing the clinical effectiveness and cost-effectiveness of a non-operative treatment pathway with appendicectomy for the treatment of uncomplicated acute appendicitis in children.
This was a mixed-methods study, which included a feasibility randomised controlled trial, embedded and parallel qualitative and survey studies, a parallel health economic feasibility study and the development of a core outcome set.
This study was set in three specialist NHS paediatric surgical units in England.
Children (aged 4-15 years) clinically diagnosed with uncomplicated acute appendicitis participated in the feasibility randomised controlled trial. Children, their families, recruiting clinicians and other health-care professionals involved in caring for children with appendicitis took part in the qualitative study. UK specialist paediatric surgeons took part in the survey. Specialist paediatric surgeons, adult general surgeons who treat children, and children and young people who previously had appendicitis, along with their families, took part in the development of the core outcome set.
Participants in the feasibility randomised controlled trial were randomised to a non-operative treatment pathway (broad-spectrum antibiotics and active observation) or appendicectomy.
The primary outcome measure was the proportion of eligible patients recruited to the feasibility trial.
Data were sourced from NHS case notes, questionnaire responses, transcribed audio-recordings of recruitment discussions and qualitative interviews.
Overall, 50% (95% confidence interval 40% to 59%) of 115 eligible patients approached about the trial agreed to participate and were randomised. There was high acceptance of randomisation and good adherence to trial procedures and follow-up (follow-up rates of 89%, 85% and 85% at 6 weeks, 3 months and 6 months, respectively). More participants had perforated appendicitis than had been anticipated. Qualitative work enabled us to communicate about the trial effectively with patients and families, to design and deliver bespoke training to optimise recruitment and to understand how to optimise the design and delivery of a future trial. The health economic study indicated that the main cost drivers are the ward stay cost and the cost of the operation; it has also informed quality-of-life assessment methods for future work. A core outcome set for the treatment of uncomplicated acute appendicitis in children and young people was developed, containing 14 outcomes. There is adequate surgeon interest to justify proceeding to an effectiveness trial, with 51% of those surveyed expressing a willingness to recruit with an unchanged trial protocol.
Because the feasibility randomised controlled trial was performed in only three centres, successful recruitment across a larger number of sites cannot be guaranteed. However, the qualitative work has informed a bespoke training package to facilitate this. Although survey results suggest adequate clinician interest to make a larger trial possible, actual participation may differ, and equipoise may have changed over time.
A future effectiveness trial is feasible, following limited additional preparation, to establish appropriate outcome measures and case identification. It is recommended to include a limited package of qualitative work to optimise recruitment, in particular at new centres.
Prior to proceeding to an effectiveness trial, there is a need to develop a robust method for distinguishing children with uncomplicated acute appendicitis from those with more advanced appendicitis, and to reach agreement on a primary outcome measure and effect size that is acceptable to all stakeholder groups involved.
Current Controlled Trials ISRCTN15830435.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in
; Vol. 25, No. 10. See the NIHR Journals Library website for further project information.
Abstract
Background
Previous research has identified the need for a randomised controlled trial (RCT) evaluating the most appropriate corticosteroid induction regimen to be used for children and ...young people (CYP) with juvenile idiopathic arthritis (JIA). A recent qualitative study found that parents and CYP understood trial concepts and were able to identify potential flaws in a proposed RCT. This confirms the need to involve parents and CYP in co-designing RCTs to best meet the needs of future trial participants. We aimed to co-design components of an RCT of corticosteroid regimens with CYP and parents living with JIA.
Methods
A focus group was conducted with CYP with JIA and parents as part of a wider consensus and discussion group meeting within the Steroid Induction Regimen for Juvenile Idiopathic Arthritis (SIRJIA) study in December 2018. The discussion focused on two components of the RCT design: i) Discussing the most appropriate treatment protocols; and ii) Addressing practicalities associated with an RCT.
Results
Two RCT protocol options, chosen through an online survey by a clear majority out of a possible eight protocols, were discussed and critiqued: i) Protocol A (intravenous vs intraarticular corticosteroid delivery); and ii) Protocol B (intravenous vs intraarticular vs intramuscular vs oral corticosteroid delivery). Several issues pertaining to both protocols were raised, related to the influence of age and past experience, routes of administration and concerns over randomisation. Participants emphasised the importance of clinicians/researchers discussing all of the potential risks with them. Participants also wanted enough information to make an informed choice. Participants emphasised the usefulness of combining trial visits with regular follow-up appointments to minimise the burden of taking part in an RCT and had a preference for their usual hospital being the site they visited. Some participants remarked that videos could be a useful way of conveying information beyond traditional participant information sheets. Some also felt that awareness of research opportunities is not equally accessible to them either, depending on where they lived in the country. Participants would want to be kept regularly updated about the progress of the RCT and felt that incentives were a good way of keeping people engaged, although some were apprehensive about hearing negative treatment results. With regards to dissemination, participants felt that study results should be readily available to them in an accessible format, should they wish to view them.
Conclusion
CYP and parents have a considerable amount of knowledge and experience which can shape the design of RCTs. With adequate support, complex concepts such as treatment protocols can be discussed and critiqued. Involving CYP and parents at the design stage of an RCT has been shown to eliminate some potential challenges in the future.
Conflicts of Interest
The authors declare no conflicts of interest.
Purpose:
The current project sought to examine whether delivery of lung cancer risk projections (calculated using the Liverpool Lung Project LLP risk model) predicted follow-up smoking status.
...Design:
Two single-blinded randomized controlled trials.
Setting:
Stop Smoking Services in Liverpool (United Kingdom).
Participants:
Baseline current smokers (N = 297) and baseline recent former smokers (N = 216) were recruited.
Intervention:
Participants allocated to intervention groups were provided with personalized lung cancer risk projections, calculated using the LLP risk model.
Measures:
Baseline and follow-up questionnaires explored sociodemographics, smoking behavior, and lung cancer risk perceptions.
Analysis:
Bivariate analyses identified significant differences between randomization groups, and logistic regression models were developed to investigate the intervention effect on the outcome variables.
Results:
Lung cancer risk projections were not found to predict follow-up smoking status in the trial of baseline current smokers; however, they did predict follow-up smoking status in the trial of baseline recent former smokers (odds ratio: 1.91; 95% confidence interval: 1.03-3.55).
Conclusion:
The current study suggests that lung cancer risk projections may help maintain abstinence among individuals who have quit smoking, but the results did not provide evidence to suggest that lung cancer risk projections motivate current smokers to quit.
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