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Assessment and screening | anxiety disorder, mood disorders, depressive disorder, depressive, psychiatric, depressive symptoms, T2DM, diabetes distress | SCID | A clinical psychologists conducted in-depth clinical interviews with patients in one-on-one settings. In the interview, the central focus was given to exploring the current presenting complaints, duration of illness, nature of the problems, and symptoms severity in terms of psychiatric problems. In order to cross check, the symptoms severity baseline measures, i.e., DDS (for diabetes distress) and PHQ (for depressive symptoms severity) were administered. Moreover, patients under treatment and experiencing T2DM for the last 6 months and experiencing depressive symptoms more than 2 weeks were selected for this RCT. Structured Clinical Interview for Diagnosis (SCID) was used to screen out any patients suffering from major depressive disorder, persistent mood disorders and health anxiety disorder and such patients were excluded. They were excluded from this RCT because they were referred for further psychological evaluation and treatment (i.e., psychiatric medication if need and extensive psychotherapy along with T2DM treatment). Furthermore, participants who achieved mean item score of 3 or above (moderate distress) on DDS and were belonging to mild depressive symptoms category or higher on PHQ were considered eligible for this RCT because they had diabetes distress and depressive symptoms due to T2DM and they were coming for treatment on regular bases. They were then randomly assigned to the two different treatment conditions. | PMC9896442 |
Procedure | Participant enrollment started on the 10th of July 2021, and trial completed on the 31st of December 2021, at different hospitals in the Faisalabad. Initially, participants’ baseline assessment was completed in the hospital’s outpatient setting. After qualifying the eligibility criteria, participants were interviewed and were invited for intake at the psychoogical clinic. Participants who met the study criteria and gave written informed consent to participate in the study were registered for this randomized clinical trial. Participants assigned to treatment conditions were assessed (pre-assessment), and at treatment completion, they were again assessed (post-assessment) with the duration of 4 months between the two assessments. We provided 8 to 10 CBT-based therapeutic sessions based on a particular agenda and goal (see interventions). Participants allocated to waitlist control were also assessed at pre-and post-assessment stages with the same time interval allocated for the experimental group. | PMC9896442 | ||
Randomization | depressive | We randomly assigned participants to treatment conditions so that both conditions were with similar and matchable group characteristics. Furthermore, all the patients were blinded with respect to the identification of the group they were assigned to. We told the participants that they were being randomized to receive psychological treatment, and its goal was to reduce their level of distress and depressive symptoms. | PMC9896442 | |
Interventions | During the initial briefing, the participants were guided about the advantages of adherence and disadvantages of non-adherence, the importance of quality of life [ | PMC9896442 | ||
Waitlist control condition | Participants allocated to the waitlist control condition received no treatment for 16 weeks. Their pre-and post-assessment was completed with the same time interval as that of the experimental group. | PMC9896442 | ||
Assessment measures | PMC9896442 | |||
Demographic information | obesity | OBESITY, HYPERTENSION | The demographic form that was used comprised of personal information from patients; such as age, education, socioeconomic status, family system, total family members, marital status, duration of illness, and the hospital name. In addition, the information related to their illness such as glucose level, duration of treatment, type of treatment, the dose of insulin, hypertension, obesity family history, was also asked in the demographic form. This form was used for further analysis and to tabulate results. | PMC9896442 |
Primary outcomes measures | PMC9896442 | |||
Diabetes distress scale (DDS-17) [ | emotional-related distress, diabetes, interpersonal-related distress, Diabetes Distress | DIABETES | Diabetes Distress Scale DDS-17 is an instrument used to assess the level of distress among diabetes patients. It consists of 17 items. It has a six-point Likert scale where 1 means no problem and 6 indicates serious issues or problems. It has four subscales emotional-related distress, physician-related distress, regimen-related distress, and interpersonal-related distress. A mean item score of 3 or above is considered worthy of clinical attention (moderate distress). Its reliability was reported at 0.87. | PMC9896442 |
The patient health questionnaire-9 (PHQ) [ | depression, depressive symptoms, depressive, depressive disorders | The PHQ is a nine-item depression scale. It is based directly on the diagnostic criteria for major depressive disorders in the Diagnostic and Statistical Manual Fifth Edition. The PHQ scores range from 0 to 3 from not at all to nearly every day, respectively. It has five ranges of severity, i.e., minimal depressive symptoms, mild depressive symptoms, moderate depressive symptoms, moderately severe depressive symptoms, and severe depressive symptoms. The scores on this self-report measure do not provide a diagnosis on their own as a diagnosis necessitates a detailed clinical investigation. PHQ reliability estimation is 0.89. | PMC9896442 | |
Secondary outcomes measures | PMC9896442 | |||
Short health anxiety inventory (SHAI) [ | anxiety | The SHAI is an instrument widely used to assess anxiety about the health status of a person. It consists of 18 items. Items assess the worries about health, awareness of bodily sensations or changes, and feared consequences of having an illness. The SHAI has demonstrated good reliability 0.86 and criterion validity 0.8. | PMC9896442 | |
Revised version of diabetes quality of life questionnaire (RV-DQOL) [ | diabetes | DIABETES | The RV-DQOL instrument is used to measure the quality of life among diabetes patients. It consists of 13 items and has three domains: satisfaction, impact, and worry. It has a 5-point Likert scale from “no impact/no worries” to “always satisfied/always affected.” The reliability of DQOL is 0.92 and 0.84, for worry, 0.98 and 0.60, for faction and, for “impact,” 0.99 and 0.57, respectively. | PMC9896442 |
General medication adherence scale (GMAS) [ | PMC9896442 | |||
International physical activity questionnaire (IPAQ) [ | The IPAQ measures the amount of physical activity performed over the past 7-day period. The IPAQ includes questions about the time spent engaging in vigorous physical activities, moderate physical activities, and walking. The IPAQ is a reliable ( | PMC9896442 | ||
Statistical analysis | Descriptive statistics (Mean & SD) was used to calculate sample demographic characteristics, whereas, group characteristics were compared at pre-test using χ | PMC9896442 | ||
Results | PMC9896442 | |||
Recruitment and attrition | A total of 130 participants were recruited, and Comparison of participants’ demographic characteristics groups wise and overall | PMC9896442 | ||
Primary and secondary outcomes | anxiety, ’, depressive, depressive symptoms, depression, T2DM, diabetes distress, diabetes | DISEASE, DIABETES | We found a significant mean difference between EXP and WLC conditions in post-testing scores on PHQ which indicates CBT substantially decreased depressive symptoms among patients with T2DM. Findings indicate that significant mean differences were found between EXP and WLC groups on SHAI which indicates that the CBT played a 77% role in reducing the level of health anxiety in the experimental group. Furthermore, significant mean differences were found between baseline and post-testing scores on the scale of EBS, PDS, RDS, IDS and overall DDS between EXP and WLC which indicates CBT reduced 63% emotional burden, 68% physician burden, 66% of regimen distress, 53% of interpersonal distress and 76% of overall diabetes distress of EXP group. Similarly, EXP group was found to be significantly different as compared to WLC on PBNA, ADPB, CRNA and overall GMAS which shows that CBT also improved adherence to treatment; such as: 48% patient behavior related non-adherence, 42% additional disease and pill burden describe non-adherence, 51% cost related non adherence and 57% over all general medication adherence to treatment. Analysis reveals a significant difference between EXP and WLC after CBT on SATS, IMPS, WORS, and overall DQLS which shows CBT sessions improved satisfaction to the degree of 41%, impact to the degree of 43%, non-worried behavior to the degree of 41%, and, overall diabetes patients’ quality of life to the degree of 58%. Furthermore, findings show that CBT produced a significant difference in changing lifestyle as compared to WLC on WALS, MPAS, VPAS and IPAQ which shows that patients with T2DM improved their quality of life after getting CBT sessions; such as: walking activities to the degree of 69%, moderate physical activities to the degree of 23%, vigorous physical activities to the degree of 33%, and overall daily physical activities to the degree of 73% (see Table Mean (standard deviation) and repeated-measure ANOVA of clinical scores during pre- and post-test interventionsNote: *** = The analysis reveals that scores significantly decreased throughout the treatment among the experimental group on PHQ, HAI, and DDS, and the group’s scores enhanced on MAS. CBT played an influential role in addressing depressive symptoms, health-related anxiety, and diabetes distress. On the other hand, CBT played a supportive role in increasing treatment adherence (see Fig. Symptomatic change in PHQ, HAI, DDS and MAS scores over the course of treatment between experimental and waitlist control groups. Findings showed a significant improvement in symptoms of depression in the EXP group. The score in the pre-vs. post of the EXP group is as follows: minimal depressive symptoms 0% vs. 3.7%, mild depressive symptoms 7.4% vs.37.1%, moderate depressive symptoms 40.8% vs. 59.3%; this indicates that CBT significantly reduced depressive symptoms. Similarly, at pre-assessment, the moderate-severe depressive symptoms were in 33.4% of the participants, and severe depressive symptoms were in 18.5% of the participants which got reduced due to CBT at post-assessment, while no significant change was observed in the waitlist control group (see Table Range of symptoms severity on Patients Health Questionnaire (PHQ) between experimental and waitlist control groups at pre-and post-assessment scoresFindings show that CBT significantly improved adherence to treatment among individuals with T2DM. Post-testing analysis reveals that the individuals from the EXP group got an improvement in their treatment adherence considerably. For example, high adherence, which was at 2(7.41%) at baseline, increased 10(37.04%), good adherence, which was at 3(11.12%) at baseline, improved to 12(44.45%), partial adherence, which was at 13(46.15%) at the baseline, shrank to 3(11.12%) as people moved to higher categories, and, low adherence, which was at 6(22.23%) at baseline, again shrank to 2(7.41%) as people moved to higher categories. In the case of WLC, no significant difference was observed, such as, high adherence at baseline had 3(8.57%) participants and at post-analysis stage there were 2(5.71%); good adherence at baseline had 6(17.14%) participants and at post-analysis stage there were 5(14.29%); partial adherence at baseline had 15(42.86%) participants and at post-analysis stage there were 18(51.43%); low adherence at baseline had 9(25.71%) participants and at post-analysis stage there were 6(17.14%); whereas, poor adherence at baseline had 2(5.71%) participants and at post-analysis stage there were 4(11.43%) (see Table Score difference on General Medical Adherence Scale (GMAS) between experimental and waitlist control groups at pre-and post-assessment scores | PMC9896442 |
Discussion | diabetes mellitus, T2DM, anxiety, diabetes | DIABETES MELLITUS, COMPLICATIONS, DIABETES | Our findings present the effectiveness of CBT for patients with T2DM in order to produce substantial improvement on multiple psychophysiological health outcomes. CBT has been widely used to treat patients’ psychological problems with diabetes [Our findings show that CBT effectively addresses patients’ psychological problems with diabetes mellitus. These findings are consistent with the findings of the previous studies. CBT-based interventions help patients by bringing about psycho-education, development of better understanding and upping the motivation to of overcome and manage negative automatic thoughts, by regulating emotions, and rectifying negative beliefs [Moreover, the analysis reveals that CBT effectively helped the patients to develop a positive attitude toward life and promoted their functional outcomes through skill training [Furthermore, our analysis reveals that CBT significantly decreases health anxiety among T2DM patients in our study [In our study. CBT was tested to improve the quality of life among patients with T2DM because diabetes negatively affects quality of life [The study findings also indicate that CBT improved medication adherence. Medication adherence was focused upon because it is strongly associated with many complications of T2DM [Our findings indicate that patients with diabetes mellitus showed more physical activity after having CBT; these findings are consistent with the existing research [ | PMC9896442 |
Conclusion | anxiety, depressive, diabetic, T2DM, diabetes distress | It is concluded that CBT produced substantial improvement among patients with T2DM having diabetes distress and depressive symptoms. It has also been supported that CBT is an effective and evidence-based treatment to address diabetes distress, depressive symptoms, and health-related anxiety. CBT also improves treatment adherence and quality of life among diabetic patients. This also helps the patients to manage daily routines, sustain motivation for treatment and develop a positive attitude toward life. Finally, CBT increases treatment adherence in patients with T2DM helping being about a rapid recovery process. | PMC9896442 | |
Limitations of the study | Type II diabetes mellitus, cognitive behavior, anxiety, depressive, psychiatric, psychiatric disorders, T2DM, diabetes distress, diabetes | TYPE III DIABETES MELLITUS, DISORDERS, DIABETES | The current study has some limitations. First, only patients with Type II diabetes mellitus were taken in the study. Second, patients were taken only from outpatient departments. Third, major focus was given only to diabetes distress, depressive symptoms, health anxiety, medication adherence and physical activities; many other factors; such as, patients’ coping mechanisms, social and emotional support systems, and others comorbid medical conditions, diagnosed psychiatric disorders and aging factors, were not investigated in this study. Fourth, the cognitive behavior therapy session was mainly designed for patients with T2DM having psychiatric problems, not psychiatric disorders. Fifth point I that we could not enroll a large-enough number of participants (due to Covid-19) in this RCT that come from different age groups, especially above age 50, who might have more diabetes problems. Lastly, this RCT does not say anything about the patients who have a history of chronic diabetes greater than 10 years. Nonetheless, if future researches target the aforesaid areas, it will be a helpful contribution to the literature as well as to the generalizability of the results. | PMC9896442 |
Recommendation and implication of the study | T1DM, cognitive behavior, Cognitive behavior, diabetes mellitus, depressive, T2DM, diabetes, cancer, anxiety-related disorders | CHRONIC ILLNESSES, DIABETES MELLITUS | This paper provides contributions to fill the knowledge gap in this ignored area of research. This paper also recommends that future researchers should check the effectiveness of CBT for patients with T1DM and T2DM having severe depressive and anxiety-related disorders. This study provides valuable background for mental health practitioners to treat and develop the guidelines and protocol for patients with diabetes mellitus and other chronic illnesses such as diabetes, cancer, HIV/AIDS. Cognitive behavior therapy played a substantial role in developing patient insight and motivation, so, it is also recommended that other practitioners should carry out qualitative studies on the variables of this research in order to know the qualities and limitations of this strategy and give even more suitable strategies to deal with the problems faced with T2DM within the field of cognitive behavior therapy. | PMC9896442 |
Disclosure | None. | PMC9896442 | ||
Authors’ contributions | W.W. | Q.A. conceptualized, designed and supervised the manuscript, as well as reviewed and edited the final draft of the manuscript. S.L. prepared the study protocol, collected data, scrutinized the data, and conducted therapeutic sessions. H.A.H. helped in trial registration, analyzed the data, interpreted the results, and planned treatment. S.S. helped with data arrangement, manuscript write-up, and edited the manuscript. U. S, collected data, prepared SPSS sheet, M.S. helped in patients’ scrutiny, allocation, and care. Z.R. and W.W. helped in data collection, preparation, and therapeutic sessions. All authors reviewed the manuscript. The author(s) read and approved the final manuscript. | PMC9896442 | |
Authors’ information | Q.A- Assistant Professor-Clinical Psychology, Department of Applied Psychology, Government College University Faisalabad, Pakistan. S.L-Final year MS Clinical Psychology student, Department of Applied Psychology, Government College University Faisalabad, Pakistan. H.A.H- Assistant Professor, Institute of Clinical Psychology, University of Karachi, S.S- Associate Professor, Institute of Clinical Psychology, University of Karachi, Pakistan, U.S. Lecturer, Department of Psychology, Government College Women University Sialkot, M.S- PhD Scholar at Department of Applied Psychology, Government College University Faisalabad, Pakistan. Z. R and W. W- Assistant Professor of psychiatry, Dow university of medical sciences. | PMC9896442 | ||
Funding | There was no funding for this study. | PMC9896442 | ||
Availability of data and materials | The dataset generated and/or analyzed during the present study are not publicly available because no permission was taken from the participants and the hospital administration where the study was conducted. The datasets are available from the corresponding authors on a special request. | PMC9896442 | ||
Declarations | PMC9896442 | |||
Ethics approval and informed consent | The study protocol was approved by the Institutional Review Board (IRB), Government College University, and Faisalabad, Pakistan (i.e., Ref.No. GCUF/ERC/2270). Furthermore, the protocol was also registered and approved by the Thai Clinical Trial Registry (i.e., TCTR20210703002 on 03 July, 2021, with URL: | PMC9896442 | ||
Consent for publication | Not applicable. | PMC9896442 | ||
Competing interests | The authors declare that they have no competing interests. | PMC9896442 | ||
References | PMC9896442 | |||
Keywords | Transcutaneous carbon dioxide measurement (TcCO Open Access funding enabled and organized by CAUL and its Member Institutions | PMC10654171 | ||
Introduction | Transcutaneous COStudies comparing the accuracy and precision of TcCO | PMC10654171 | ||
Methods | MAY, SECONDARY | This report comprises a secondary publication based on additional data that were collected during a single-center randomized controlled trial undertaken between September 2018 and May 2019 at the Royal Brisbane and Women’s Hospital [All participants were monitored according to local standards, with the addition of invasive radial arterial catheters. Participants were randomized to Group T, in which they were administered high flow nasal oxygen using Optiflow THRIVE™ at 70 L/min, humidified using the Fisher & Paykel 950 humidifier, providing 70% relative humidity (oxygen concentration delivered at 100%); or to Group N, in which they were administered standard nasal prongs at 4 L/min (Salter Labs, Arvin, CA, USA). In both groups, pre-oxygenation occurred in the ramped position and with FiOInduction medications consisted of an opioid, propofol, and rocuronium with dosing at the discretion of the anesthetist. Anesthesia maintenance was achieved using propofol target controlled infusion. The patients were bag-mask ventilated to achieve an end-tidal oxygen fraction > 0.9. At this point, nasal oxygenation was applied according to group allocation and airway patency maintained using an oropharyngeal airway and two-handed airway maneuvers (chin lift, head tilt, jaw thrust).Clinical observations and sampling occurred while the participants were anesthetized and apneic. TcCOThe sample size was a convenience sample of 42, determined according to the primary outcome of the original study [ | PMC10654171 | |
Results | 42 participants had a mean (SD) age of 50.4 (11.1) years, 33 (78.6%) were female and they had a median (IQR) BMI of 52 (40–58.5) kg/mThe bias (95% CI, 95% LOA) at baseline was −1.00 mmHg (−2.47 to 0.47, −8.10 to 6.80), at T0 was 1.10 mmHg (−1.52 to 3.72, −6.10 to 11.30), and at Tend was 1.90 mmHg (−2.64 to 6.44, −7.10 to 22.90). Figure Difference plot of PaCOPaCO | PMC10654171 | ||
Author contributions | VE: concept development, protocol design, interpretation of statistical analysis, manuscript writing and review, manuscript revisions. LG: Initial concept, protocol design, ethics application, data collection, interpretation of statistical analysis and writing the manuscript; CW: protocol design, data collection, manuscript review; SL protocol design, statistical analysis, interpretation of analysis, manuscript review; AvZ: concept development, protocol design, manuscript writing and review; All authors: approval of the submitted version. | PMC10654171 | ||
Funding | Open Access funding enabled and organized by CAUL and its Member Institutions. This project was funded by a 2018 Project Grant from the Royal Brisbane and Women’s Hospital Foundation. LG was supported by a Royal Brisbane and Women’s Hospital Scholarship (2019). | PMC10654171 | ||
Data availability | Data are available on reasonable request, from the authors. | PMC10654171 | ||
Declarations | PMC10654171 | |||
Conflict of interest | Equipment for measuring TcCO | PMC10654171 | ||
References | PMC10654171 | |||
Background | epilepsy | EPILEPSY | In paediatric epilepsy, the evidence of effectiveness of antiseizure treatment is inconclusive for some types of epilepsy. As with other paediatric clinical trials, researchers undertaking paediatric epilepsy clinical trials face a range of challenges that may compromise external validity | PMC9900533 |
Main body | antiseizure | RECRUITMENT, ROLANDIC EPILEPSY | In this paper, we critically reflect upon the factors which impacted recruitment to the pilot phase of a phase IV unblinded, randomised controlled 3×2 factorial trial examining the effectiveness of two antiseizure medications (ASMs) and a sleep behaviour intervention in children with Rolandic epilepsy. We consider the processes established to support recruitment, public and patient involvement and engagement (PPIE), site induction, our oversight of recruitment targets and figures, and the actions we took to help us understand why we failed to recruit sufficient children to continue to the substantive trial phase.The key lessons learned were about parent preference, children’s involvement and collaboration in decision-making, potential and alternative trial designs, and elicitation of stated preferences pre-trial design.Despite pre-funding PPIE during the trial design phase, we failed to anticipate the scale of parental treatment preference for or against antiseizure medication (ASMs) and consequent unwillingness to be randomised. Future studies should ensure more detailed and in-depth consultation to ascertain parent and/or patient preferences | PMC9900533 |
Conclusion | The importance of diligent consultation, the consideration of novel methods such as parent/patient preference trials and/or discrete choice experiments in studies examining the effectiveness of ASMs versus no-ASMs cannot be overemphasised even in the presence of widespread clinician equipoise. | PMC9900533 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13063-023-07091-9. | PMC9900533 | ||
Keywords | PMC9900533 | |||
Background | antiseizure, epilepsy | CASTLE, RECRUITMENT, EPILEPSY, EPILEPSY | Randomised controlled trials (RCT) provide the best quality evidence for comparative effectiveness in medicine [As with other paediatric clinical trials, researchers undertaking paediatric epilepsy clinical trials face a range of challenges [The purpose of this paper is to reflect critically upon the factors which impacted recruitment to the pilot phase of the CASTLE (Changing Agendas in Sleep, Treatment and Learning in Epilepsy) RCT examining the effectiveness of two antiseizure medications (ASMs) and a sleep behaviour intervention (details below). We were aware that issues such as randomisation, equipoise, treatment, and other aspects of and parent and/or and patient preference [This paper will consider the processes which were established within the trial to support recruitment processes in the pilot CASTLE study, including our public and patient involvement and engagement (PPIE) work, the comprehensive training that underpinned site induction and our oversight of recruitment targets and figures. The paper will then report on the actions taken by the trial team to help us understand why we failed to recruit sufficient children to continue to the substantive trial phase. We reflect on the lessons learned and discuss the implications for paediatric clinical trials. | PMC9900533 |
Main text | PMC9900533 | |||
Trial description | RE, CASTLE, Rolandic epilepsy | CASTLE, ROLANDIC EPILEPSY | CASTLE was a phase IV unblinded, randomised controlled 3×2 factorial trial comparing carbamazepine, levetiracetam or active monitoring combined with or without a sleep behaviour intervention in children (≥5 to <13 years) with Rolandic epilepsy (RE) (see Supplementary File | PMC9900533 |
Patient and public involvement and engagement | antiseizure, epilepsy | CASTLE, RECRUITMENT, EPILEPSY | Children with RE and parents had been involved from the inception of the idea for the CASTLE trial. In the pre-funding stage, parents were involved in two stakeholder meetings and they helped to shape the design of the study and the development of the research questions. Our engagement with parents in the pre-trial stakeholder meetings meant that we were aware that some parents of children with RE had ambivalent feelings towards medicating their children and they talked of the difficulties they experienced when trying to weigh up the potential benefits and harms of treating their child’s epilepsy with antiseizure medications. In addition, our parent co-applicants made us aware of their uncertainty about which issues to discuss with clinicians at the time of an epilepsy diagnosis and when making treatment decisions. We were clear that these ambiguities and uncertainties would need to be carefully considered in the design of the study and child/parent-facing documents.We built on our pre-funding stakeholder work with parents when, in the early stages of the funded programme of work, we created our dedicated Patient and Public Involvement and Engagement (PPIE) Advisory Panel (AP). Our AP consists of 12 adults (including parents) with experience of childhood epilepsy, and five children with epilepsy. We recruited our AP through social media and liaison with health professionals and epilepsy charities. We worked with the AP members during face-to-face meetings and remotely (during lockdown) using open discussion facilitated by using creative methods such as road maps and idea trees and/or by email or through a dedicated WhatsApp group. The relationship and depth of consultation with the AP evolved over time and through sustained engagement.Our AP has been influential in the programme of research related to the trial. For example, we co-created a proposed Core Outcome Set (COS) for childhood epilepsy research using a Delphi process to decide which outcomes were of key importance to stakeholders and thus the trial [We specifically worked with the AP to develop the child/parent facing documentation (the trial information sheets, a short trial explainer animation) which we knew would be key to successful recruitment. Furthermore, the AP reported that the trial was quite complex for families to understand; therefore, appreciating the challenges associated with clinicians recruiting to trials we co-developed clinician-facing documentation such as a clinician guide ‘Top Tips for Recruiting Families’ sheet (Supplementary File | PMC9900533 |
Site induction and training | EVENT, RECRUITMENT | We adopted a conscientious, robust, and ongoing approach to training site research staff acknowledging that treatment preference [Prior to the pilot trial launch, we invited all site investigators (clinicians and research nurses) to an in-person recruitment training event to rehearse discussions around equipoise, how to explain randomisation [ | PMC9900533 | |
Recruitment targets, issues with recruitment and consent | CASTLE, seizure | RECRUITMENT, CASTLE, RECRUITMENT, SECONDARY, REMISSION, SAID | As a key part of quality control, throughout the internal pilot period of the trial, the CASTLE Trial Management Group performed monthly review of the trial screening data by site. The internal pilot trial aimed to assess recruitment and consent during the first 9 months of recruitment. We were guided by clear recruitment progression criteria (see Table Recruitment targetsWe were successful in site initiation; 31 sites were trained, and 29 trial sites were opened (seven more than our goal), most in secondary care paediatric centres. However, of these 29 sites, only 18 had screened at least one patient by month nine of the internal pilot. In total, 100 patients were screened (see Figs. Internal pilot screening and recruitment summaryRecruitment against original target in CASTLE pilotNon-consent for 19 of the 50 eligible patients (38%) was due to some parental preference about treatment: 14 did not want medication, three did not want ‘no treatment’, and two had a ‘treatment preference’ (one against carbamazepine, another in favour of any medication). One patient was too far along their natural course towards remission (seizure free for 4 years). Of the remaining 14 approached, three did not want to take part in research, one said it would be too time-consuming, parental responsibility was not clear for one family and the remaining nine did not provide a reason. | PMC9900533 |
Actions taken by the trial team to understand the reasons for low recruitment | RECRUITMENT | As it became clear that the consent rate was poor and not improving, it was apparent we needed to understand the factors impacting on the recruitment rate. To this end, we consulted and engaged with our two key stakeholder groups: health professionals involved with recruitment and parents and children from our AP. | PMC9900533 | |
Consultation with health professionals undertaking recruitment | seizures | CASTLE, RECRUITMENT | In recognition of our recruitment challenges, we consulted paediatricians and research nurses responsible for recruitment during the internal pilot to engage in an exercise to understand their perceptions and experiences of recruitment to the trial. Having utilised the HRA decision tool (Despite the disruption to services resulting from the COVID-19 pandemic, 12 clinicians and two research nurses from 14 of the 29 sites shared their views (17th March–15th April 2020) as part of the consultation; seven clinicians and two research nurses were consulted via telephone and five clinicians responded to questions by email. A further five sites acknowledged our request but were unable to provide responses to our consultation as they had neither approached nor recruited families to participate in the trial. Of the 14 sites who engaged in the consultation, four had recruited a child/family, seven sites had experience of families declining to participate (Overall, clinicians were positive about the CASTLE trial considering it to be “However, a significant difficulty for individual sites was identifying potential participants who met the eligibility criteria. Some clinicians explained that fewer patients than expected (pre-trial commencement) met the trial eligibility criteria, typically noting that since the study opened eligible patients were simply “The families were reported as giving the clinicians various reasons for declining to participate in the CASTLE trial. Most frequently, the concept of randomisation in the CASTLE trial was reported as causing some unease amongst families where parents had commented that their child’s seizures were “However, despite the above challenges some initially reluctant families changed their minds about participating due to changing circumstances. One family was reported to have changed their mind after their child started “The clinicians reported that most of the families were interested in the sleep intervention and noted that “In summary, consultation with clinicians highlighted that some parents expressed strong medication related preferences; this meant randomisation to a potentially non-preferred arm discouraged parents. However, clinicians considered that the parent treatment preference issue was less likely to impact on recruitment to a trial that only involved randomisation to either sleep intervention plus usual care or usual care only. | PMC9900533 |
Engagement with our PPIE advisory panel (AP) | RECRUITMENT | Although we had engaged with stakeholders from the inception of the study, our full AP was not established until after some of the key trial design decisions (e.g. research questions, interventions and design) had been taken.As recruitment and consent challenges became evident, we dedicated time in February 2020 to discuss this at an AP meeting, with seven parents present. They discussed and expressed a range of opinions about how parent preference for treatment/non-treatment was likely to be an important factor influencing trial participation. One parent proposed that medicine randomisation “The TMG requested further input from the AP about their perspectives on the potential of an alternative design proposing a Patient Preference Trial (PPT) design focusing solely on the sleep behaviour intervention but without the comparison between carbamazepine and levetiracetam. A remote AP meeting was held with 11 parents and five children to explore their views on the proposed PPT design and ensure their expert feedback informed any proposed design. All the parents unanimously reported that the proposed PPT design was more acceptable to them than the original trial design as it was “The increased focus on sleep in the proposed PPT trial design was deemed important with parents highlighting how “ | PMC9900533 | |
Discussion of the lessons we learned | The discussion that follows addresses the key lessons we learned about parent preference, children’s collaboration in decision-making to participate, alternative trial designs and elicitation of stated preferences pre-trial design. Each of these is critically considered before drawing final conclusions. | PMC9900533 | ||
Parent preference | Parent preference, particularly treatment preference, is an important factor across paediatric RCTs, not least because of the proxy role that parents often play in making treatment decisions [Treatment preference is a key influence which has been found to lead to declining participation in up to 70% of a variety of 52 trial designs [Post hoc trial surveys suggest that parents with higher socio-economic status, high decisional uncertainty and low levels of trust and altruism were more likely to decline trial participation [ | PMC9900533 | ||
Children’s collaboration in decision-making to participate | RECRUITMENT | Children’s ability to participate in research is vulnerable to adult proxies. Considering this, we started from the premise that children want to collaborate in decision-making about participating in medical research [Our original site training reflected our awareness that bespoke training of people undertaking trial recruitment of children and parents has been shown to improve clarity and balance of explanations and increase recruitment [ | PMC9900533 | |
Consideration of alternative trial designs | seizures, epilepsy | EPILEPSY | With failure to recruit to our randomised controlled factorial trial, we needed to consider how to take our programme of work forward. Potentially core to our failure to recruit is the fact that ASMs do not generally modify the natural history of epilepsy but aim to prevent the occurrence of seizures and consequent harm. There has been only one placebo-controlled paediatric RCT of ASMs in RE [ | PMC9900533 |
Elicitation of stated preferences pre-trial design | antiseizure, epilepsy | RECRUITMENT, EPILEPSY | A key lesson was that despite our pre-funding stakeholder engagement, we had failed to anticipate the scale of parental treatment preference against antiseizure medication (ASMs) randomisation. In future work, this should be considered. More detailed and robust work to ascertain patient preferences earlier in the trial design process might have identified likely barriers to recruitment and informed the design of the RCT at an earlier stage.As it became clear that low recruitment meant that the original trial design could not proceed, the consultation with clinicians and families conducted led us to recognise that trial designs with PPT elements were favoured by the clinicians, parents, and children with epilepsy. We propose that discrete choice experiments (DCEs) have potential in this regard. DCEs can elicit patients’ stated preferences for health technologies, interventions, and services [The design of a DCE requires formative work to identify suitable attributes and attribute levels [ | PMC9900533 |
Limitations | The lessons we have learned are contextual and are based on consultation with a small number of health professionals and the parents and children in our AP and not on direct engagement with children (and their parents) who were eligible to participate in the trial. This limits the representativeness of our consultation and the extent to which the reasons for declining participation can be unravelled. | PMC9900533 | ||
Conclusions | seizures, epilepsy | EPILEPSY | Paediatric epilepsy poses particular challenges for clinical trial design, planning and execution, frequently resulting from discordance of perception, understanding and sharing of information between parents, children and clinicians regarding both the impact of seizures and potential benefits and harms of ASMs. The importance of careful consultation and planning of novel interventions and intervention trials cannot be overplayed even in the presence of widespread clinician equipoise. | PMC9900533 |
Acknowledgements | Thank you to the children, young people and parents who are part of our Patient and Public Involvement and Engagement Advisory Panel (AP). | PMC9900533 | ||
Authors’ contributions | DAH, CM, CTS | Substantial contributions to the conception or design of the work (DKP, CTS, LB, BC, AC, DAH, EW, GC, LW, PG); the acquisition, analysis, or interpretation of data for the work (DKP, NAN, ATP, CTS, CS, LB, BC, AC, HC, DAH, RM, ARS, HS, VW, GC, LW, PG); drafting the work or revising it critically for important intellectual content (DKP, NAN, ATP, CTS, CS, LB, BC, AC, DAH, EF, RM, CM, ARS, HS, VW, LW, PG); final approval of the version to be published (DKP, NAN, ATP, CTS, CS, LB, BC, AC, HC, JC, DAH, EW, RM, CM, DR, ARS, HS, VW, GC, LW, PG); agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved (all authors). The authors read and approved the final manuscript. | PMC9900533 | |
Funding | This study is funded by NIHR Programme Grant for Applied Research RP-PG-0615-20007. The views and opinions expressed in this paper are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health. | PMC9900533 | ||
Availability of data and materials | CASTLE | CASTLE | The CASTLE trial was terminated after the pilot. The datasets used and/or analysed during the CASTLE pilot as well as select trial materials are available from the corresponding author (DP) on reasonable request (see also pages 53-54 of the attached protocol). The information from the consultation with the health professionals is not available as this is not research data. | PMC9900533 |
Declarations | PMC9900533 | |||
Ethics approval and consent to participate | The trial received ethics approval (NIHR reference: RP-PG-0615-20007, London Riverside Research Ethics Committee reference: 19/LO/0452). Documented informed consent/assent was obtained from all participants. The consultation exercise with the health professionals did not require ethics approval (as per outcome from our use of the HRA decision tool ( | PMC9900533 | ||
Consent for publication | Not applicable | PMC9900533 | ||
Competing interests | The authors declare that they have no any competing interests. | PMC9900533 | ||
References | PMC9900533 | |||
Introduction | Edited by: Graça S. Carvalho, University of Minho, PortugalReviewed by: Robert J. Wellman, UMass Chan Medical School, United States; Lucia Romo, Université Paris Nanterre, France†These authors have contributed equally to this work and share first authorshipAlcohol consumption is the main substance abused during university and is associated with physical, legal, emotional, social, and cognitive consequences. The peer-led BASICS intervention has been shown to be effective in decreasing the quantity and frequency of drinking, the estimated peak blood alcohol concentration (BAC), and the number of binge drinking episodes among this population. | PMC10644667 | ||
Objective | This study evaluated the effectiveness of the peer-led BASICS intervention to reduce risky alcohol consumption among university students in the Spanish context. | PMC10644667 | ||
Materials and methods | A two-arm randomized controlled trial in a university in northern Spain including 308 first- and second-year university students recruited between October 2022 to March 2023. The intervention was a 30-min in-person peer-led motivational interview. Participants were assessed at baseline and 1-month postintervention. The primary outcome was the quantity and frequency of alcohol consumption during a typical week. The intervention effect was verified using a mixed factorial ANOVA model. | PMC10644667 | ||
Results | Compared with students in the control group, students who received the intervention reduced the number of drinks per week by 5.7 (95% CI 5.54, 5.86); the number of drinks consumed in a typical weekend by 5.2 (95% CI 5.07, 5.33); the number of drinks consumed on the occasion of greatest consumption by 4.9 (95% CI 4.78, 5.02); the number of binge drinking episodes by 1.4 (95% CI 1.37, 1.43); the peak BAC on a typical week and on the occasion of greatest consumption decreased by 0.06 (95% CI 0.058, 0.062) and 0.09 (95% CI 0.088, 0.092); the number of alcohol-related consequences by 5.8 (95% CI 5.67, 5.93); and the motivation to change their alcohol use increased by −0.8 (95% CI −0.85, −0.75). | PMC10644667 | ||
Conclusion | The peer-led BASICS intervention is effective in changing alcohol consumption and its related consequences among Spanish university students in the short term. The action of nursing students as counselors positively impacted drinking patterns among their peers. | PMC10644667 | ||
1. Introduction | Alcohol consumption peaks in emerging adulthood (18–25 years old), a vital stage in which half of this population consume excessive alcohol or engage in binge drinking (five or more drinks on an occasion for men, or four or more drinks on an occasion for women) (Motivational interventions (MI) have been shown to be effective when implemented in university settings (A recent literature review indicated that when BASICS is delivered by peers, there is a reduction in the quantity and frequency of drinking, estimated peak blood alcohol concentration (BAC) and number of binge drinking episodes among college students ( | PMC10644667 | ||
2. Materials and methods | PMC10644667 | |||
2.1. Study design | This was a two-arm randomized controlled trial conducted in a university in northern Spain. The trial protocol was registered with | PMC10644667 | ||
2.2. Training of peer facilitators | The intervention was delivered by volunteer fourth-year undergraduate nursing students who attended a 12-week, 2 h training course (12 h for theoretical classes and 10 h for practice workshops) that was conducted over one semester, from September to December 2022. The course covered concepts related to MI that were structured into three modules: 1. motivational interviewing; 2. alcohol and university students; and 3. feedback (as a strategy for MI). Lectures were delivered by a faculty nurse member who was an expert in the field. The teaching methodologies were didactic lectures, video visualizations, and role play exercises. Upon completion of the theoretical classes, students conducted two | PMC10644667 | ||
2.3. Sample size | The sample size was estimated by assuming an expected decrease in quantity and frequency of alcohol consumption that was higher than that reported in a previous randomized controlled trial ( | PMC10644667 | ||
2.4. Participants and recruitment | RECRUITMENT | The study participants were university students recruited from a university in northern Spain between October 1, 2022, and March 14, 2023. The inclusion criteria were as follows: age 18-years or older; first- or second-year student status; and currently engaging in binge drinking.The recruitment strategy involved advertising in university classrooms and student residences and disseminating the study through the university's social networks and the student newsletter. One member of the research team provided information about the project and invited students to participate. It was explained to the participants that it was a health promotion project at the university with the objective of raising their awareness about their pattern of alcohol consumption and its effects on young people. They were blinded to the goal of the study (to reduce alcohol consumption) to prevent them from reporting lower alcohol use at the end of the study. Furthermore, they were not informed of the existence of two groups. Students signed up using a QR code redirected to a Google sheet to provide their name and contact email. Subsequently, they were e-mailed a document containing information about the study and the informed consent form that they had to return signed to participate in the study. Those students who met eligibility criteria were then randomly assigned to either the control or intervention group. | PMC10644667 | |
2.5. Randomization, allocation concealment, and blinding | Simple randomization of participants was performed by generating a random number sequence using Stata v.15. The number sequence was stored on an encrypted electronic file, and one researcher was the only study staff member with access to this information. Participants, following the order of enrolment in the study, were assigned to an intervention or control group according to the corresponding random sequence number. Study investigators, peer facilitators and participants were blinded to participant allocation. | PMC10644667 | ||
2.6. Measures | SECONDARY | The primary outcome was the quantity and frequency of alcohol consumption during a typical week, which was measured using the Daily Drinking Questionnaire-Revised (DDQ) (The following eight secondary outcomes were measured: the number of drinks consumed on a typical weekend and on the occasion of greatest consumption, as measured through the DDQ; the highest BAC during a typical week and on the occasion of greatest consumption, estimated using the quantity/frequency/peak index (QF) Index (All outcome measures accounted for alcohol consumption during the past month.These assessments were made twice: before (baseline assessment) and 1 month after the program (follow-up assessment). | PMC10644667 | |
2.7. Data collection | Participants were informed about their group assignment (intervention or control) by e-mail and were asked to complete the online baseline assessment using the Survey Monkey platform. This questionnaire included 25 questions divided into two sections: sociodemographic variables (first eight questions), such as sex, hometown, and faculty; and 17 questions about their history of alcohol consumption and alcohol-related consequences during the previous month. One month after the interview (for de intervention group) or after the baseline questionnaire (for the control group), students received an e-mail directing them to complete the 1-month follow-up assessment via Survey Monkey. This assessment consisted of the same alcohol-related questions referring to the outcome variables. If they did not complete it, they were sent a reminder and the link by the smartphone messaging app WhatsApp. | PMC10644667 | ||
2.8. Intervention | The intervention is based on the BASICS manual (Participants in the control group did not receive any specific intervention which is the standard-of-care at the university where the study took place. | PMC10644667 | ||
2.9. Statistical analysis | REGRESSION | Baseline data were reported as the mean [standard deviation (SD)] for continuous variables since all of them followed a normal distribution. Categorical variables were reported as percentages (The data were analyzed on an intention-to-treat basis. The intervention effect was verified using a mixed factorial ANOVA model in which the intervention time (pre and post) was the within-subjects factor, and the intervention group (control and intervention) was the between-subjects factor. For statistically significant interactions, the differences between the groups at an intervention time were verified by means of contrasts using Fisher's least significant difference (LSD) adjustment. Normality was assessed using the Shapiro–Wilk test on the residuals together with visual verifications of the boxplot and Q–Q plot.To study the possible confounding effect of demographic variables on the results, the mixed factorial ANOVA model was repeated, including these data as covariables.Poisson regression was used to test the effect of the intervention on the low/high risk of Weekly DDQ adjusting for baseline characteristics and unadjusted. The variable number of weekly drinks assessed using the DDQ instrument was categorized into a nominal qualitative variable (high-risk and low-risk consumption) following the indications of the NIAAA that considers low-risk consumption for women no more than seven drinks per week and for men no more than 14 (All the analyses were carried out in Stata version 16. For all tests, results for which | PMC10644667 | |
2.10. Ethical considerations | This research was approved by the Research Ethics Committee of the university where the research was conducted (code: 2021.162). Institutional permission was obtained, and all participants signed a written informed consent form. To maintain confidentiality, the participants' details were codified. | PMC10644667 | ||
3. Results | PMC10644667 | |||
3.2. Baseline characteristics | Participants characteristics of the study are shown in Baseline characteristics of participants by groups.Pearson's χThere were no significant differences at baseline between the intervention group and the control group for sociodemographic variables and alcohol use and alcohol-related consequence outcomes. | PMC10644667 | ||
3.3. Primary outcomes | A significant intervention effect was observed on the primary outcome alcohol consumption in a typical week (mean: intervention 6.6 vs. control 12.3; | PMC10644667 | ||
4. Discussion | SECONDARY | This is the first study to evaluate the effectiveness of the peer-led BASICS intervention in reducing alcohol consumption among Spanish university students. The results confirm our main hypothesis, indicating that the intervention positively impacts alcohol use by significantly decreasing the number of drinks consumed in a typical week. In addition, the findings in the secondary outcomes were promising, demonstrating significant reductions in the drinks per weekend, drinks on peak occasion, binge drinking episodes, peak BAC on a typical week, peak BAC on peak occasion, alcohol-related consequences and the motivation to change alcohol use. These findings are in line with a recent meta-analysis that showed that BASICS was the most effective intervention among brief alcohol interventions delivered in the college setting (Our main finding was that participants in the intervention group significantly reduced the number of drinks per week by 5.7 compared to the control group. In line with our results, only three studies including the peer-led BASICS intervention have shown a significant reduction in the number of drinks per week by 5.24 (In addition, to reinforce the encouraging results related to the main hypothesis, our study is the first investigation demonstrating the impact of peer-led BASIC intervention on drinks per weekend, drinks on peak occasion, peak BAC on a typical week, and the motivation to change alcohol use. Regarding the number of binge drinking episodes, our results suggest that the intervention exceeds the results of previous studies. While our study revealed a reduction of 1.4 episodes of binge drinking, Pueyo-Garrigues et al. (There could be several explanations for these encouraging findings. First, BASICS intervention has been shown to be effective in addressing alcohol use in college students (Given the demonstrated effectiveness of BASICS, we believe that the size of the effect obtained is also due to the fact that the intervention was led by peers who have received specific training. This can be a strength since the values, habits and lifestyles of young people are especially susceptible to peer influence (Additionally, the training of the peer counselors who have led the BASICS intervention might be another key element related to the success of this study. Students received a training program with proven effectiveness in conducting motivational interviews about alcohol consumption with their peers (Three main limitations in this study need to be recognized. First, the study was carried out at a single university, so the participants in the treatment groups could have influenced each other. However, the importance of not sharing the information received to participants in the control group was impressed upon participants in the intervention group and an intention-to-treat analysis was applied to avoid the effects of crossover. Second, as we aimed to determine the short-term effects of the intervention, the follow-up period was short. For future studies, it would be interesting to carry out measurements over an extended follow-up period to determine the long-term effects of the intervention. Third, the outcome measures were all self-reported. To try to avoid any bias in these measurements, participants were insisted that they were not going to be judged and that they should respond as honestly as possible. In addition, we follow recommendations to improve the reliability and validity of these measures, such as: collecting data online, asking for longer timeframes and questions which involve specified timeframes; and, including beverage-specific questions (Despite these limitations, this study had some strengths. First, all the participants assigned to the intervention group received the motivational interview. Furthermore, no participants in either group were lost to follow-up. This may be due to the commitment that the students acquired by participating in the study, their positive experience when receiving the interview, the relationship established with the peer counselors, or the reminders sent through WhatsApp. Second, the students who led the intervention were totally devoted to the project, and after each interview, peer facilitators spoke with the research team to discuss how the interview had gone, their concerns and areas for improvement. Finally, the selected intervention is underpinned by a strong foundation in behavior change theory, peer-led interventions, motivational interviewing principles, and harm reduction approaches, which have been shown to be appropriate for this age group. | PMC10644667 | |
5. Conclusion | In conclusion, the peer-led BASICS intervention was effective in changing alcohol consumption among Spanish university students in the short term. Nursing students positively impacted the drinking pattern of their peers, achieving significant decreases in the amount of alcohol consumption, binge drinking episodes, peak BAC, and alcohol-related consequences. Nursing undergraduates can be considered a great asset for health promotion at the university setting. Future studies are needed to determine the long-term effectiveness of peer-led BASICS interventions. | PMC10644667 | ||
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. | PMC10644667 | ||
Ethics statement | The study involving humans was approved by Research committee from the University of Navarra. The study was conducted in accordance with the local legislation and institutional requirements. The participants provided their written informed consent to participate in this study. | PMC10644667 | ||
Author contributions | ML-G: Conceptualization, Formal analysis, Funding acquisition, Investigation, Methodology, Writing—original draft. MP-G: Conceptualization, Funding acquisition, Methodology, Supervision, Writing—review & editing. DC: Formal analysis, Writing—review & editing. NE-L: Writing—review & editing. CA-D: Writing—review & editing. NC-A: Conceptualization, Funding acquisition, Methodology, Supervision, Writing—review & editing.We thank the Bank Santander-University of Navarra for providing a grant and the Association of Friends of the University of Navarra for their financial collaboration in this project. | PMC10644667 | ||
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10644667 | ||
Publisher's note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. | PMC10644667 |
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