Randomized Controlled Trials Of Interventions Research Articles

Substance Use Within Trials of Psychological Interventions for Psychosis: Sample Inclusion, Secondary Measures, and Intervention Effectiveness.

Current clinical guidelines recommend that patients with co-occurring psychosis and alcohol or substance use disorders (A/SUD) receive evidenced-based treatment for both disorders, including psychological intervention for psychosis. However, the efficacy of such treatments for individuals with co-occurring psychosis and A/SUD is unclear. Randomized controlled trials (RCTs) of psychological interventions for psychosis were systematically reviewed, to investigate how alcohol and substance use has been accounted for across sample inclusion and secondary measures. Findings from trials including individuals with co-occurring alcohol or substance use issues were then narratively summarized using the Synthesis Without Meta-Analysis guidelines, to indicate the overall efficacy of psychological interventions for psychosis, for this comorbid population. Across the 131 trials identified, 60.3% of trials excluded individuals with alcohol or substance use issues. Additionally, only 6.1% measured alcohol or substance use at baseline, while only 2.3% measured alcohol or substance use as a secondary outcome. Across trials explicitly including individuals with alcohol or substance use issues, insufficient evidence was available to conclude the efficacy of any individual psychological intervention. However, preliminary findings suggest that psychoeducation (PE) and metacognitive therapy (MCT) may be proposed for further investigation. Overall, co-occurring alcohol and substance use issues have been largely neglected across the recent RCTs of psychological interventions for psychosis; highlighting the challenges of making treatment decisions for these individuals using the current evidence base.

Developing Guidance for Donor Intervention Randomized Controlled Trials: Initial Discussions From the Canada-United Kingdom 2022 Workshop.

Donor interventions, including medications, protocols, and medical devices administered to donors, can enhance transplantable organ quality and quantity and maximize transplantation success. However, there is paucity of high-quality evidence about their effectiveness, in part because of ethical, practical, and regulatory challenges, and lack of guidance about conduct of donor intervention randomized controlled trials (RCTs). With the vision to develop authoritative guidance for conduct of donor intervention RCTs, we convened a workshop of Canadian-United Kingdom experts in organ donation and transplantation ethics, research, and policy to identify stakeholders, explore unique challenges, and develop research agenda to inform future work in this promising field. Donor intervention trials should consider perspectives of broad group of stakeholders including donors, transplant recipients, and their families; researchers in donation and transplantation; research ethics boards; and healthcare providers and administrators involved in donation and transplantation. Unique challenges include (1) research ethics (living versus deceased status of the donor at the time of intervention, intervention versus outcomes assessment in different individuals, harm-benefit analysis in donors versus recipients, consent, and impact on research bystanders); (2) outcome data standardization and linkage; and (3) regulatory and governance considerations. Donor intervention RCTs hold potential to benefit organ transplantation outcomes but face unique research ethics, outcome data, and regulatory challenges. By developing research agenda to address these challenges, our workshop was an important first step toward developing Canada-United Kingdom guidance for donor intervention RCTs that are poised to improve the quality and availability of transplantable organs.

Development of a core outcome set for use in research evaluations of interventions for venous leg ulceration: International eDelphi consensus

IntroductionVenous leg ulceration (VLU) is a chronic, recurring condition with associated pain, malodour, impaired mobility and susceptibility to infection which in turn significantly impacts an individual's health-related quality of life. Randomised controlled trials (RCTs) aim to determine the efficacy of interventions to improve outcomes. To be useful, these outcomes should be consistently and fully reported across RCTs. A core outcome set (COS) is an agreed-upon standardised set of outcomes which should be, at a minimum, reported in all RCTs for a given indication including that of VLU. AimTo gain consensus on which outcome domains and outcomes should be considered as core and therefore included in all RCTs of interventions in VLU treatment. MethodTwo sequential, two round e-Delphi surveys were completed. The first gained consensus on core outcome domains and the second on core outcomes within those domains. Participants included: people with direct experience of having VLUs and their carers, healthcare professionals whose practice included VLU care and researchers within wound care (clinical, academic, industry). ResultsFive outcome domains; healing, pain, quality of life, resource use and adverse events, and 11 outcomes were rated as core by participants. The patient and not the limb or ulcer was the preferred unit of analysis for reporting. RecommendationsWe recommend investigators report on all five outcome domains, regardless of the type of intervention being evaluated. Future research is needed to identify measurement methods for the 11 identified outcomes. We also recommend investigators follow the CONSORT guidelines (http://www.consort-statement.org/).

Evaluation of compliance of CONSORT-CHM formula 2017 in randomized controlled trials of Chinese herbal medicine formulas: protocol of a five-year review.

Background: The CONSORT Extension for Chinese Herbal Medicine Formula 2017 (CONSORT-CHM Formula 2017) has established a reporting standard for randomized controlled trials (RCTs) of Chinese Herbal Medicine Formula (CHMF) interventions; however, its adherence and implications for the design and execution of study design remain ambiguous. It is necessary to evaluate the level of compliance with the CONSORT-CHM Formula 2017 in RCTs conducted over the past 5years, and to determine the reporting quality of clinical trials in this field. Methods: First, a systematic search is conducted for RCTs on CHMF in EBM Reviews, Allied and Complementary Medicine (AMED), Embase, Ovid-MEDLINE(R), Wanfang data, China National Knowledge Infrastructure (CNKI), VIP Chinese Medical Journal Database (VIP) and Chinese Biomedical Literature (CBM) database, that encompassed CHMF interventional RCTs published from 1 January 2018 to 8 June 2022, with language restriction to English or Chinese. Second, a descriptive analysis will be performed regarding the study design and general characteristics of the included trials. Third, for the quality assessment, we have subdivided the CONSORT-CHM Formula 2017 checklist (consisting of 22 extended items) into a total of 42 sub-questions to facilitate scoring, with a specific focus on the description, quality control, and safety assessment of CHMF interventions. Professional training and a pilot test on 100 randomly selected articles will be provided for all reviewers. Throughout this process, a standard operating procedure (SOP) for quality assessment will be developed to ensure consistency. Each item will be assessed by two reviewers in a paired back-to-back manner, and the compliance rate will be calculated to assess inter-rater agreement. Discussion: This review will identify the current reporting characteristics and quality of CHMF interventional studies and further evaluate the impact of CONSORT-CHM Formula 2017. The results may provide suggestions for future application or promotion of the guideline. Registration: The study has been registered on Open Science Framework (https://osf.io/xpn7f).

A68 PERCEPTIONS OF ADOLESCENTS AND YOUNG ADULTS WITH INFLAMMATORY BOWEL DISEASE REGARDING A BIOPSYCHOSOCIAL TRANSITION INTERVENTION: A QUALITATIVE STUDY

Abstract Background The transition from the pediatric to adult care healthcare system for adolescents and young adults (AYAs) with inflammatory bowel disease (IBD) is complex. This group requires support to prepare for and adapt to adult care due to the manifestation of the disease, expectations for self-management, and simultaneous life transitions. To address this need, a multi-site randomized controlled trial (RCT) is being conducted to evaluate the impact of a multimodal transition intervention on functional, clinical, and psychosocial outcomes for AYAs with IBD. An embedded qualitative study explored participants’ perspectives of the intervention's acceptability and appropriateness to support the translation of findings into practice. Aims Using in-depth individual qualitative interviews with a purposive sample of AYAs in both the intervention and control arms of the RCT, this qualitative study aimed to understand AYAs’ experiences preparing for and undergoing service transitions, developing self-management skills, and engaging with the intervention. Methods Semi-structured interviews were held via videoconference with 21 AYAs aged 16-18 years participating in the RCT (intervention arm n=11; control arm n=10) in Toronto, Canada. Purposive sampling was used to recruit AYAs with diverse demographic and clinical characteristics at different stages of the healthcare transition. Interviews were audio-recorded, transcribed verbatim, and analyzed using an inductive approach to reflexive thematic analysis. Results The analysis yielded four overarching themes related to 1) individual, familial, and system-level factors promoting transition readiness, 2) areas of strength and areas for growth regarding self-management skill development, 3) perceptions of the multimodal transition intervention, including barriers and facilitators to engagement, and 4) recommendations for future transition care, including refinement of the intervention. Findings to date indicate the criticality of considering AYAs’ support systems, learning styles, and communication preferences when designing and implementing transition interventions. The qualitative data analysis is ongoing, and the full results will be presented. Conclusions The perspectives of AYAs with IBD can inform the development and refinement of clinical interventions, ensuring they are tailored to recipients’ unique needs and preferences and promote engagement and skill development during pediatric-adult transitions. Funding Agencies CCCThe Leona M. and Harry B. Helmsley Charitable Trust

Effectiveness of Physical Activity Interventions in Sedentary People during COVID-19 Lockdown: A Systematic Review of Randomized Controlled Trials

Background: The social restriction measures during the COVID-19 pandemic resulted in decreasing physical activity levels. We aimed to evaluate whether the interventions reported in randomized controlled trials (RCTs) assessing the effects of physical activity during the COVID-19 lockdown on people with sedentary behavior were effective. Methods: We searched several databases from their inception until 1 April 2023, including RCTs evaluating the effects of any physical activity intervention in increasing the physical activity level in people with sedentary behavior during COVID-19 confinement, based on evidence derived from intervention studies with a control group. Studies were excluded if they (i) did not include humans; (ii) did not include sufficient information regarding the interventions or regarding the outcomes of interest; (iii) did not have a control group. We used the Rayyan systematic review platform for the selection of the studies to include based on the title/abstract information. Results: Starting with 2461 records from the original literature search, and after reviewing them according to the latest PRISMA recommendations, 11 RCTs including a total of 1770 participants were available and were included in the systematic review. We found that most of the studies examined (73%) reported the beneficial effects of the proposed interventions on improving the physical activity, reducing the sedentary time, and positively contributing to the psychological well-being of the participants. Conclusions: The results of the present systematic review on RCTs of interventions to increase physical activity in sedentary people during the COVID-19 lockdown show the beneficial effects of diverse online-delivered strategies, which can be applied even after the pandemic in conditions in which access to in-person activities is not possible.

Placebo and Nocebo Responses in Pharmacological Trials of Tic Disorders: A Meta-Analysis.

Clinical trials of new drugs for tic disorders (TD) often fail to yield positive results. Placebo and nocebo responses play a vital role in interpreting the outcomes of randomized controlled trials (RCTs), yet these responses in RCTs of TD remain unexplored. The aim was to assess the magnitude of placebo and nocebo responses in RCTs of pharmacological interventions for TD and identify influencing factors. A systematic search of the Embase, Medline, Cochrane Central Register of Controlled Trials, and PsycINFO databases was conducted. Eligible studies were RCTs that compared active pharmacological agents with placebos. Placebo response was defined as the change from baseline in TD symptom severity in the placebo group, and nocebo response as the proportion experiencing adverse events (AEs) in this group. Subgroup analysis and meta-regression were performed to explore modifying factors. Twenty-four trials involving 2222 participants were included in this study. A substantial placebo response in TD symptom severity was identified, with a pooled effect size of -0.79 (95% confidence interval [CI] -0.99 to -0.59; I2 = 67%). Forty-four percent (95% CI 27% to 63%; I2 = 92%) of patients experienced AEs while taking inert pills. Sample size, study design, and randomization ratio were correlated with changes in placebo and nocebo responses. There were considerable placebo and nocebo responses in TD clinical trials. These results are of great relevance for the design of future trials and for clinical practice in TD. PROSPERO registration ID CRD42023388397. © 2024 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

The Fulfillment Center Intervention Study: Protocol for a group-randomized control trial of a participatory workplace intervention.

Warehousing and storage is an economically vital industry, with 1.2 million workers in 2020. The Fulfillment Center Intervention Study focuses on workers in fulfillment centers in the e-commerce segment of this industry. Fulfillment centers are a growing yet understudied work environment which provides a unique setting to further examine how working conditions and worker voice influence health. The Study involves a group-randomized controlled trial comparing participants in worksites randomized to launch the participatory intervention (Health and Well-Being Committees, or HaWCs) with participants working for the same firm in control sites. HaWCs serve as a new formal voice channel where a small group of frontline workers and supervisors solicit workers' concerns and ideas about safety (e.g., physical hazards), the psychosocial environment (e.g., how workers feel about their treatment at work), and work organization (e.g., workflow, training opportunities, scheduling) and then develop and implement improvement projects in response. The primary objectives of the study are to evaluate the efficacy of the HaWC intervention and its effect on mental health outcomes and changes in the conditions of work within fulfillment centers, and to conduct a process evaluation of key contextual factors that support effective intervention implementation and sustained engagement. To our knowledge, this will be the first trial of a participatory intervention within a fulfillment center setting. Anticipated challenges include competing demands and company initiatives that may limit management support and high turnover. Should the intervention be shown to be feasible, the outcomes from this study will inform future randomized controlled trials of participatory interventions. Trial registration: This trial is registered with the ClinicalTrials.gov registry (NCT05199415) and approved by the Institutional Review Board (IRB) at the Massachusetts Institute of Technology (Protocol: 200800024).

Blinding Induced Risk of Bias in Randomized Controlled Trials of Physiotherapy Interventions — A Retrospective Study

Introduction: In randomized clinical trials, the methodological idea of preventing bias by withholding knowledge of the allocation status is known as blinding. Blinding refers back to the concealment of group allocation from one or extra individuals concerned in scientific studies, most commonly a randomized controlled trial (RCT). Even though randomization minimizes variations among treatment groups on the outset of the trial, it does nothing to prevent differential treatment of the groups later within the trial or the differential assessment of outcomes, either of which may also bring about biased estimates of treatment outcomes. The most beneficial strategy to limit the chance of differential remedy or assessments of results is to blind as many individuals as viable in a trial. Objective: To study the extent of blinding induced bias in RCT of physiotherapy interventions and to evaluate the extent of interpretative consideration it the trials are not blinded in the sample of RCT included. Methodology : We conducted a retrospective analysis to estimate the blinding bias in the randomized controlled trials published in physiotherapy interventions from 2016 to 2022. Results & Conclusion : We included 50 RCTs for blinding assessment. About 88% of included articles were not having participants blinding 90% has not done therapist blinding and nearly 50% of studies were conducted without assessors blinding. Based on the results of this study blinding of important participants were infrequently reported in the included studies. Keywords: Blinding, Risk of bias, Physiotherapy, Randomized controlled trials

In Ischemic Heart Disease, Reduced Sensitivity to Pressure at the Sternum Accompanies Lower Mortality after Five Years: Evidence from a Randomized Controlled Trial.

Background: Autonomic nervous system dysfunction (ANSD) is associated with negative prognosis of ischemic heart disease (IHD). Elevated periosteal pressure sensitivity (PPS) at the sternum relates to ANSD and sympathetic hyperactivity. Two previous observational case-control studies of the effect of reduction of PPS suggested lower all-cause mortality from IHD and stroke. We now used a specific daily, adjunct, non-pharmacological program of reduction of elevated PPS to test the hypothetical association between the intervention and reduced all-cause mortality in patients with stable IHD in a randomized controlled trial (RCT). Methods: We completed active (n = 106) and passive interventions (n = 107) and compared the five-year mortalities. We also compared the five-year individual all-cause mortality of each participant to approximately 35.000 members of the general population of Denmark. Pooling the mortality data from the active group of the RCT with the two preliminary studies, we registered the mortality following active intervention of 1.168 person-years, compared to 40 million person-years of the pooled general population. Results: We recorded fewer deaths of the active RCT intervention group than of the corresponding control group from the general population (p = 0.01), as well as of the passive RCT intervention group (p = 0.035). The meta-analysis of the three studies together demonstrated reduced 4.2-year all-cause mortality of 60% (p = 0.007). Conclusions: The test of the hypothetical effect of an intervention aimed at the attenuation of ANSD accompanied by a lowered PPS revealed reduced all-cause mortality in patients with stable IHD.

Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis.

Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis.

A systematic review and meta-analysis of the effectiveness of hypertension interventions in faith-based organisation settings.

Hypertension is the global, leading cause of mortality and is the main risk factor for cardiovascular disease. Community-based partnerships can provide cost-saving ways of delivering effective blood pressure (BP) interventions to people in resource-poor settings. Faith-based organisations (FBOs) prove important potential health partners, given their reach and community standing. This potential is especially strong in hard-to-reach, socio-economically marginalised communities. This systematic review explores the state of the evidence of FBO-based interventions on BP management, with a focus on randomised controlled trials (RCTs) and cluster RCTs (C-RCTs). Seven academic databases (English = 5, Chinese = 2) and grey literature were searched for C-/RCTs of community-based interventions in FBO settings. Only studies with pre- and post-intervention BP measures were kept for analysis. Random effects models were developed using restricted maximum likelihood estimation (REML) to estimate the population average mean change and 95% confidence interval (CI) of both systolic and diastolic blood pressure (SBP and DBP). The overall heterogeneity was assessed by successively adding studies and recording changes in heterogeneity. Prediction intervals were generated to capture the spread of the pooled effect across study settings. Of the 19 055 titles identified, only 11 studies of fair to good quality were kept for meta-analysis. Non-significant, average mean differences between baseline and follow-up for the intervention and control groups were found for both SBP (0.78 mm of mercury (mmHg) (95% CI = 2.11-0.55)) and DBP (-0.20 mm Hg (95% CI = -1.16 to 0.75)). Subgroup analysis revealed a significant reduction in SBP of -6.23 mm Hg (95% CI = -11.21 to -1.25) for populations with mean baseline SBP of ≥140 mm Hg. The results support the potential of FBO-based interventions in lowering SBP in clinically hypertensive populations. However, the limited evidence was concentrated primarily in Christian communities in the US More research is needed to understand the implications of such interventions in producing clinically meaningful long-term effects in a variety of settings. Further research can illuminate factors that affect success and potential expansion to sites outside the US as well as non-Christian FBOs. Current evidence is inadequate to evaluate the potential of FBO-based interventions in preventing hypertension in non-hypertensive populations. Intervention effects in non-hypertensive population might be better reflected through intermediate outcomes.

The Effects of Acupuncture on Crohn's Disease: a systematic review and meta-analysis.

Crohn's disease is a chronic gastrointestinal disease that belongs to inflammatory bowel disease. This systematic review aims to assess the level of evidence in randomized controlled trials (RCTs) on the effects of acupuncture for Crohn's disease. We searched 12 databases from the date of the establishment of each database up to May, 2023 for relevant RCTs. The risk of bias of each study was assessed independently by three reviewers. The level of evidence of meta-analysis was assessed using GRADE (Grading of Recommendations, Assessment, Development, and Evaluation). A total of 12 studies were included. The effective rate (odds ratio [OR] 3.23, 95% confidence interval [CI] 1.43, 7.30) for mild to moderate Crohn's disease patients showed a significant difference between the acupuncture with moxibustion group and the sham-acupuncture with sham-moxibustion group. CDAI change (mean difference [MD] -74.15, 95% CI -93.28, -55.01) for mild to moderate Crohn's disease showed a significant difference between the acupuncture with moxibustion group and the sham-acupuncture with sham-moxibustion group. Although acupuncture with moxibustion showed significant effects compared to sham-acupuncture with sham-moxibustion, the effect of acupuncture alone is inconclusive. Moreover, only the effect of acupuncture treatment on mild to moderate Crohn's disease patients was derived as a remarkable result. To confirm the effectiveness of acupuncture treatment for Crohn's disease, studies using only acupuncture for intervention or more RCTs targeting various Crohn's disease patients according to the CDAI are required.

Quality of reporting of randomized controlled trials of top 10 herbs prescribed in Thailand

IntroductionGiven the questionable quality of reporting of randomized controlled trials (RCTs) of herbal interventions, especially in developing countries, this study aims to evaluate the quality of reporting of RCTs of the top 10 herbs prescribed in Thailand and published in Thai healthcare journals. MethodsA systematic search was conducted within five databases: PubMed, Cochrane Library, Thai Journal Online, Thai Index Medicus, and Online Public Access Catalog of Khon Kaen University for Thai and English herbal medicine intervention RCTs published in Thai healthcare journals. Reporting quality of RCTs was assessed by using adapted CONSORT Herbal Intervention and CONSORT 2010 comprised of 52 items. ResultsOf 1351 potential studies, 16 RCTs met the eligibility criteria. For the quality of reporting by each item of 16 included studies, 27 of 52 items were reported in at least 50 % of RCTs which data on participants, physical characteristics of the herbal product, similarity of interventions, baseline data, numbers analyzed, ancillary analyses, and generalizability were reported in all included RCTs when applicable. However, 20 items had less than 50 % reported in included RCTs. There were no included RCTs reported information on the participant flow diagram, registration, and protocol. Discussion/ConclusionsThe quality of reporting of Thai herbal invention RCTs published in Thai healthcare journals was suboptimal. Improvement in the reporting quality of Thai herbal RCTs was needed to provide a high level of evidence. Relevant Thai healthcare journals should encourage Thai herbal medicine RCT authors to follow the CONSORT statement and herbal medicine intervention extensions.

Physical Exercise as a Potential Treatment for Fatigue in Parkinson's Disease? A Systematic Review and Meta-Analysis of Pharmacological and Non-Pharmacological Interventions.

Fatigue is one of the most common and debilitating non-motor symptoms among patients with Parkinson's disease (PD) and significantly impacts quality of life. Therefore, effective treatment options are needed. To provide an update on randomized controlled trials (RCTs) including pharmacological and non-pharmacological (but non-surgical) treatments that examine the effects of fatigue on PD patients. We searched the MEDLINE, EMBASE, PsycINFO, CENTRAL, and CINAHL databases for (cross-over) RCTs on pharmacological and non-pharmacological interventions for treating fatigue in PD patients until May 2021. Meta-analyses for random-effects models were calculated when two or more studies on the same treatment option were available using standardized mean differences (SMDs) with 95% confidence intervals (CIs). Fourteen pharmacological and 16 non-pharmacological intervention RCTs were identified. For pharmacological approaches, a meta-analysis could only be performed for modafinil compared to placebo (n = 2) revealing a non-significant effect on fatigue (SMD = - 0.21, 95% CI - 0.74-0.31, p = 0.43). Regarding non-pharmacological approaches, physical exercise (n = 8) following different training approaches versus passive or placebo control groups showed a small significant effect (SMD = - 0.37, 95% CI - 0.69- - 0.05, p = 0.02) which could not be demonstrated for acupuncture vs. sham-acupuncture (SMD = 0.16, 95% CI - 0.19-0.50, p = 0.37). Physical exercise may be a promising strategy to treat fatigue in PD patients. Further research is required to examine the efficacy of this treatment strategy and further interventions. Future studies should differentiate treatment effects on physical and mental fatigue as the different underlying mechanisms of these symptoms may lead to different treatment responses. More effort is required to develop, evaluate, and implement holistic fatigue management strategies for PD patients.

Data extraction error in pharmaceutical versus non-pharmaceutical interventions for evidence synthesis: Study protocol for a crossover trial

BackgroundData extraction is the foundation for research synthesis evidence, while data extraction errors frequently occur in the literature. An interesting phenomenon was observed that data extraction error tend to be more common in trials of pharmaceutical interventions compared to non-pharmaceutical ones. The elucidation of which would have implications for guidelines, practice, and policy. Methods and analysesWe propose a crossover, multicenter, investigator-blinded trial to elucidate the potential variants on the data extraction error rates. Eligible 90 participants would be 2nd year or above post-graduate students (e.g., masters, doctoral program). Participants will be randomized to one of the two groups to complete pre-defined data extraction tasks: 1) group A will contain 10 randomized controlled trials (RCTs) of pharmaceutical interventions; 2) group B will contain 10 RCTs of non-pharmaceutical interventions. Participants who finish the data extraction would then be assigned to the alternative group for another round of data extraction after a 30 min washout period. Finally, those participants assigned to A or B group will be further 1:1 randomly matched based on a random-sequenced number for the double-checking process on the extracted data. The primary outcome will be the data extract error rates of the pharmaceutical intervention group and non-pharmaceutical group, before the double-checking process, in terms of the cell level, study level, and participant level. The secondary outcome will be the data error rates of the pharmaceutical intervention group and non-pharmaceutical group after the double-checking process, again, in terms of the cell level, study level, and participant level. A generalized linear mixed effects model (based on the above three levels) will be used to estimate the potential differences in the error rates, with a log link function for binomial data. Subgroup analyses will account for the experience of individuals on systematic reviews and the time used for the data extraction. DiscussionThis trial will provide useful evidence for further systematic review of data extraction practices, improved data extraction strategies, and better guidelines. Trial registrationChinese Clinical Trial Register Center (Identifier: ChiCTR2200062206).

Do single-case experimental designs lead to randomised controlled trials of cognitive behavioural therapy interventions for adolescent anxiety and related disorders recommended in the National Institute of Clinical Excellence guidelines? A systematic review.

Although Cognitive Behavioural Therapy (CBT) is effective for 60% of adolescents with anxiety disorders, only 36% are in remission post-intervention. This indicates that more effective treatments are needed which should be reflected in the NICE guidelines. We hypothesised that Single-case experimental designs (SCEDs) may provide a framework for accelerating the development of novel interventions. The primary purpose of this review was to investigate whether SCEDs are currently followed by randomised controlled trials (RCTs) of CBT intervention for adolescent anxiety disorders named in the NICE guidelines. The secondary objective was to investigate whether using SCEDs prior to RCTs could be a helpful approach. For the primary search of SCEDs five databases were used (PsycINFO, PubMed, PsycArticles, Web of Science and ProQuest). Nineteen articles met eligibility criteria including a total of 107 participants. For the secondary search of RCTs named in the NICE guidelines for adolescent anxiety disorders 53 articles met inclusion criteria and were included in the systematic review. The 19 SCED studies included in the review were conducted with participants with a diverse range of anxiety disorders and across a range of CBT formats. Two of the SCEDs were followed by RCTs, but neither of these were named in the NICE guidelines for anxiety disorders. All of the SCEDs identified were rated as low quality with none meeting the criteria for the highest or second highest quality rating. From the secondary searches, none of the RCTs named in the NICE guide were preceded by SCEDs. It was concluded that currently SCEDs were not followed by RCTs of CBT interventions named in the NICE guidelines for adolescent anxiety disorders. However, it was suggested that SCEDs may provide an important framework for the development of more effective interventions for adolescents with anxiety.

Protocol: carrageenan for the prevention of oral HPV infection – a feasibility randomised clinical trial

IntroductionHead and neck cancers (HNCs) are a significant health burden worldwide. Oral human papillomavirus (HPV) infection is a major risk factor for HNCs. Unfortunately, currently available prophylactic vaccines have limited...

Reality of Family Caregiving for Hispanics With Alzheimer's Disease and Related Dementias: A Qualitative Analysis.

Background: Underserved Hispanic patients often experience unmet palliative care (PC) needs, particularly those with noncancer diagnoses such as Alzheimer's disease and related dementias. Most caregivers for Hispanic patients are family relatives who are less likely to use health care and community resources and experience high caregiver burden. We adapted a culturally tailored patient navigator (PN) intervention to provide support and improve PC outcomes for Hispanics with Alzheimer's disease and related dementias and their family caregivers (FCGs). Objectives: To explore Hispanic FCGs' experiences and perceptions of caregiving for a loved one, and how our PN intervention impacted their needs. Design: Qualitative descriptive. Setting/Subjects: FCG participants (n = 10) from our randomized control trial's intervention group were recruited from academic and safety net hospitals and community-based clinics across urban and rural Colorado in the United States. Measurements: Data obtained from individual, semistructured, 30-minute telephone interviews were recorded, transcribed, translated, and analyzed using NVivo and qualitative thematic analyses. Results: Four major themes emerged: Methods of Support, Cultural Expectations and Varying Family Contributions, Lack of Self-Care, and Awareness. Subthemes highlighted differing definitions of "contributing," role resentment, and interpersonal issues. Varying familial expectations underscore FCG strain when the burden of caregiving is not shared. Participants used various coping strategies as necessary support and gained awareness through education, guidance, and referrals to resources. Conclusions: PNs helped FCGs and patients beyond the intervention's scope. Providing support and awareness to FCGs, and incorporating cultural beliefs, may improve PC access to disparate populations and guide future interventions. Clinical Trial Registration Number NCT03181750.

Exercise for counteracting weight recurrence after bariatric surgery: a systematic review and meta-analysis of randomized controlled trials.

Exercise is recommended to prevent post-surgical weight recurrence. Yet, whether exercise interventions are efficacious in this regard has not been systematically evaluated. Moreover, clinicians lack evidence-based information to advise patients on appropriate exercise frequency, intensity, time, and type (FITT) for preventing weight recurrence. Thus, we conducted a meta-analysis of randomized controlled trials (RCTs) involving exercise interventions specifying FITT and weight measurement ≥12 months post-surgery. We reviewed scientific databases up through February 2022 for RCTs comparing exercise interventions reporting FITT and a nonexercise control group on weight ≥12 months post-surgery. Procedures following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses were registered at the international prospective register of systematic reviews (PROSPERO: CRD42022342337). Of 1368 studies reviewed, 5 met inclusion criteria (n = 189; 47.8 ± 4.2 yr, 36.1 6 ± 3.8 kg·m2, 83.2 ± 9.5% female; 61.7% underwent Roux-en-Y gastric bypass). Exercise interventions were largely supervised, lasted 12-26 weeks, and prescribed 80-210 minutes/week of moderate-to-vigorous intensity combined aerobic and resistance exercise over ≤5 days. Within-group effects showed non-statistically significant weight loss for exercise (d= - .15, 95% confidence interval [CI]: -1.96, 1.65; -1.4 kg; P = .87) and weight gain for control (d = .11, 95% CI: -1.70,1.92; +1.0 kg; P = .90), with no difference between these groups(d=-2.26, 95% CI: -2.07, 1.55; -2.4 kg; P = .78). Exercise elicited an additional 2.4 kg weight loss versus control, although this effect was small and statistically non-significant. Abilityto draw definitive conclusions regarding efficacy of exercise interventions for counteracting post-surgical weight recurrence was limited by the small number of trials and methodological issues. Findings highlight the need for more rigorous RCTs of exercise interventions specifically designed to reduce post-surgical weight recurrence.