title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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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... | 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 a... | 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 p... | 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 trea... | 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, regime... | 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 sym... | 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, 0.9... | 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 pla... | 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 pro... | 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... | 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; ma... | 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 menta... | 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 ... | 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 Psych... | 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 inva... | 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 ... | 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, manus... | 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 ... | 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 impa... | 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 sta... | 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 t... | 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 recruitm... | 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 servi... | 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 dis... | 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 ... | 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 r... | 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 har... | 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... | 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... | 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 im... | 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 intellect... | 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 profe... | 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... | 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 univers... | 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... | 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, ... | 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 eff... | 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 str... | 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 adver... | 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, wer... | 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, ... | 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, hom... | 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... | 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 ... | 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... | 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 & editi... | 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 ... | PMC10644667 |
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