Randomised Control Trial Protocol Research Articles

Effectiveness of personalized rehabilitation in adults suffering from persistent concussion symptoms as compared to usual care: a randomized control trial protocol

BackgroundSymptoms reported by patients who sustain a concussion are non-specific. As such, clinicians are better able to manage patients when a standardized clinical exam is performed to sub-type the driver(s) of symptoms. Aerobic exercise and multimodal rehabilitation have consistently shown to be a possibly effective means to manage this population; however, the optimal training prescription is unclear. Thus, there is a need to further examine the effectiveness of personalized rehabilitative treatments. Our primary aim is to evaluate the response to personalized therapy on recovery, as measured by The Rivermead Post-concussion Symptoms Questionnaire (RPQ) when compared to an active control.MethodsWe will conduct a multi-center 12-week case-crossover randomized controlled trial. 50 participants will be recruited from out-patient University Health Network clinics and community-based clinical practices around the greater Toronto area. Participants will be randomized at baseline to Group A: a personalized care program followed by an active control or Group B: an active control followed by a personalized care program. Participants will be included should they be 21 years of age and older and have symptoms that have persisted beyond 4 weeks but less than 1 year. Participants will undergo 6-weeks of care in their respective streams. After 6-weeks, participants will undergo a re-examination. They will then crossover and undertake the alternative treatment for 6 weeks. At the end of 12 weeks, participants will undertake the endpoint examinations. The primary outcome will be the Rivermead Postconcussion Questionnaire (RPQ). The secondary outcomes will be changes in standardized clinical examination, Neck Disability Index (NDI), Patient Health Questionnaire (PHQ-9) and an electroencephalography (EEG) via NeuroCatch™. The statistical analysis to be performed is composed of an adjusted model using an analysis of variance, specifically using an unpaired t-test to test for associations between variables and outcomes.DiscussionGiven the recommendations from reviews on the topic of rehabilitation for adults with persistent concussion symptoms, we are undertaking a controlled trial. The documented high costs for patients seeking care for persistent symptoms necessitate the need to evaluate the effectiveness of a personalized rehabilitative program compared to the current standard of care.Trial registrationClinicalTrials.gov ID: NCT06069700.

Status-neutral community-based multilevel intervention to address intersectional stigma and discrimination, and increase HIV testing, PrEP, and ART uptake among YGBMSM in Ghanaian Slums: A clustered randomized control trial protocol.

While GBMSM constitute less than 2% of Ghana's population, their HIV prevalence surpasses the national average by more than eightfold, emphasizing the critical need for targeted interventions to improve detection, care linkage, and reduce community transmission. This study seeks to increase HIV testing, Pre-Exposure Prophylaxis (PrEP), and Antiretroviral Therapy (ART) uptake (HPART) among YGBMSM through the adaptation of an evidence-based intervention (LAFIYA). We will employ the ADAPTT-IT framework to adapt LAFIYA and evaluate its feasibility and effectiveness in addressing intersectional stigma and increasing HPART uptake among YGBMSM residing in Ghanaian slums. In aim 1, we will hold focus groups (n=5) and interviews (n=20) among YGBMSM and two FGDs among GBMSM-led organizations. At the HCF level, we will hold 6 FGDs and interviews (n=20) among nurses. In AIM 2, we will randomly assign 6 healthcare facilities (HCFs) to receive the LAFIYA (n=3) or wait-list control (n=3). Friend groups (cluster) of YGBMSM (N=240) will be assigned to receive LAFIYA (n=120) or a wait-list control (n=120). We will collect 3-, 6-, and 9-months post-intervention data among YGBMSM(n=240) and HCWs(n=300) to measure HPART adherence (primary outcomes), ISD reduction, HIV and status-neutral knowledge (secondary outcomes), and intervention acceptability, appropriateness, and feasibility (implementation outcomes). The intervention group will observe increased HPART adherence, reduced ISD, and enhanced HPART knowledge and efficacy relative to the wait-list control group. The findings will inform ISD reduction and HIV status-neutral implementation strategies - and place-based interventions that address access to HIV prevention and care among YGBMSM, slum and in different settings. This study was registered on clinicalTrail.gov, with identifier number NCT06312514 on 03/14/2023. https://classic.clinicaltrials.gov/ct2/show/NCT06312514.

Cognitive training via mobile app for addressing eating disorders’ cognitions in adolescents: a randomized control trial protocol

During adolescence, individuals are particularly vulnerable to developing eating disorders (EDs). To address the dysfunctional beliefs linked to these disorders, a new mobile app has been developed. This app, called GG eating disorders-Adolescents (GGED-AD), was created based on CBT to help adolescents work on their self-dialogue related to the core beliefs of eating disorders. The objective is to present the protocol for a randomized controlled trial to explore the efficacy of GGED-AD.Methods The study will be carried out in adolescents aged 13 to 16 from an educational center in the Valencian Community. The participants will be randomized into two groups: the experimental group will use the GGED-AD app during 14 consecutive days for approximately 5 min each day; and the control group will use a neutral app (GGNEUTRAL) during the same time. Both groups will complete instruments that assess dysfunctional beliefs related to eating disorders, eating symptoms, symptoms of depression and anxiety, body satisfaction and self-esteem before and after the intervention. A follow-up will be conducted one month later.Results A decrease in the degree of ascription to dysfunctional beliefs associated with eating disorders and eating symptomatology is expected, as well as an increase in body satisfaction and the self-esteem of the participants of the experimental group.Discussion The app in this study could help tackle and prevent ED-related symptoms in adolescents.Trial registration NCT06039514.

Reporting completeness of nutrition and diet-related randomised controlled trials protocols

Background and AimsThere is a need to consolidate reporting guidance for nutrition randomised controlled trial (RCT) protocols. The reporting completeness in nutrition RCT protocols and study characteristics associated with adherence to SPIRIT and TIDieR reporting guidelines are unknown. We, therefore, assessed reporting completeness and its potential predictors in a random sample of published diet and nutrition-related RCT protocols. MethodsWe conducted a meta-research study of 200 nutrition and diet-related RCT protocols published in 2019 and 2021 (aiming to consider periods before and after the start of the COVID pandemic). Data extraction included bibliometric information, general study characteristics, compliance with 122 questions corresponding to items and subitems in the SPIRIT and TIDieR checklists combined, and mention to these reporting guidelines in the publications. We calculated the proportion of protocols reporting each item and the frequency of items reported for each protocol. We investigated associations between selected publication aspects and reporting completeness using linear regression analysis. ResultsThe majority of protocols included adults and elderly as their study population (n=73; 36.5%), supplementation as intervention (n=96; 48.0%), placebo as comparator (n=89; 44.5%), and evaluated clinical status as the outcome (n=80; 40.0%). Most protocols described a parallel RCT (n=188; 94%) with a superiority framework (n=141; 70.5%). Overall reporting completeness was 52.0% (SD=10.8%). Adherence to SPIRIT items ranged from 0% (n=0) (data collection methods) to 98.5% (n=197) (eligibility criteria). Adherence to TIDieR items ranged from 5.5% (n=11) (materials used in the intervention) to 98.5% (n=197) (description of the intervention). The multivariable regression analysis suggests that a higher number of authors [β=0.53 (95%CI: 0.28-0.78)], most recent published protocols [β=3.19 (95%CI: 0.24-6.14)], request of reporting guideline checklist during the submission process by the journal [β=6.50 (95%CI: 2.56-10.43)] and mention of SPIRIT by the authors [β = 5.15 (95%CI: 2.44-7.86)] are related to higher reporting completeness scores. ConclusionsReporting completeness in a random sample of 200 diet or nutrition-related RCT protocols was low. Number of authors, year of publication, self-reported adherence to SPIRIT, and journals’ endorsement of reporting guidelines seem to be positively associated with reporting completeness in nutrition and diet-related RCT protocols.

The effectiveness of pharmacist-led educational model in adult patients with allergic rhinitis: a single-center randomized control trial protocol (AR-PRISE RCT)

BackgroundAllergic rhinitis is a chronic respiratory disorder that significantly impacts patients’ quality of life (QoL) and work performance. Pharmacists are recognized as suitable professionals to provide patient education and pharmaceutical care for managing allergic rhinitis patients. However, local clinical practice guidelines, particularly regarding pharmaceutical care in public healthcare institutions, are lacking. This study protocol outlines a randomized controlled trial (RCT) designed to evaluate the effectiveness of a pharmacist-led educational model (AR-PRISE Model) in managing allergic rhinitis in adult patients compared to standard pharmaceutical care. The AR-PRISE model delivers patient educational material and a pharmaceutical care algorithm.MethodThis is a 6-month, single-center, prospective, randomized, two-arm, and parallel-group controlled trial. The trial recruits patients attending the otorhinolaryngology clinics of a tertiary referral hospital. Participants are randomized into control or intervention groups in a 1:1 ratio using permuted block randomization. The total number of participants estimated is 154, with each group requiring 77 participants. The control group receives standard pharmaceutical care, while the intervention group receives pharmacist-led education according to the AR-PRISE model. Both groups are assessed for middle turbinate endoscopy findings, disease severity, knowledge level, symptom control, medication adherence, and QoL at baseline and the end-of-study follow-up (day 180 ± 7). Depending on feasibility, intermediate follow-ups are conducted on days 60 ± 7 and 120 ± 7, either virtually or face-to-face. During intermediate follow-ups, participants are assessed for symptom control, medication adherence, and QoL. The intention-to-treat analysis includes all participants assigned to each group. An independent T-test compares the mean difference in knowledge level between the two groups. A two-way repeated measures ANOVA analysis is employed to determine between-group differences for scores of symptom control, adherence rate, and QoL. A P-value < 0.05 is considered statistically significant.DiscussionThis study protocol will provide a framework for conducting a randomized controlled trial (RCT) to evaluate the effectiveness of pharmacist-led education intervention in managing allergic rhinitis within public healthcare settings. The parameters measured in this trial will quantify outcomes associated with improvements in symptoms and QoL. By systematically assessing these outcomes, we aim to contribute valuable insights into the role of pharmacist-led interventions in enhancing the management of allergic rhinitis in public healthcare settings.Trial registrationClinicalTrials.gov NCT06027736. Registered on 9 July 2023—retrospectively registered.

Mobility and strength training with and without protein supplements for pre-frail or frail older adults with low protein intake: the Maximising Mobility and Strength Training (MMoST) feasibility randomised controlled trial protocol

Background Frailty is a common syndrome affecting older people and puts them at risk of hospitalisation, needing care or death. First signs of frailty include reduced muscle strength and mobility decline. A key cause of mobility decline as we age is sarcopenia (age related reduction in muscle strength and mass). Poor nutrition contributes to sarcopenia. A shortfall in protein is associated with reduced muscle mass and strength. This may be due to inadequate intake but also because older people have higher protein needs, especially those with multimorbidity. We need to develop effective treatment to reduce or slow the onset of frailty and mobility decline. Exercise is a recommended treatment. Protein supplements to address the shortfall in protein have the potential to enhance the benefit of regular exercise in frail or pre-frail older adults. This has yet to be definitively demonstrated. Aim To establish the feasibility of conducting an RCT evaluating mobility and strength training with or without protein supplements for people over 60 years old who are frail or pre-frail with a low protein intake. Methods A multicentre, parallel, 2-group, feasibility RCT. Participants (recruitment target = 50) with problems walking, low protein intake and classified as frail or pre-frail will be recruited from four NHS Physiotherapy community services. Participants will be randomised (secure computer-generated: 1:1) to receive 24 weeks of mobility and strength training (delivered in 16 group sessions plus home exercises) or 24 weeks of mobility and strength training with daily protein supplements. Primary feasibility objectives are to estimate 1) ability to screen and recruit eligible participants, 2) intervention fidelity, adherence, and tolerance and 3) retention of participants at follow up. Secondary objectives are to 1) test data collection procedures, 2) assess data completeness and 3) confirm sample size calculation for a definitive RCT. Registration ISRCTN Registry (ISRCTN30405954; 18/10/2022).

Efficacy of endoscopic submucosal resection with a ligation device for small rectal neuroendocrine tumor: study protocol of a multicenter open-label randomized control trial (BANDIT trial)

BackgroundEndoscopic resection is widely accepted as a local treatment for rectal neuroendocrine tumors sized ≤ 10 mm. However, there is no consensus on the best method for the endoscopic resection of rectal neuroendocrine tumors. As a simplified endoscopic procedure, endoscopic submucosal resection with a ligation device (ESMR-L) indicates a histologically complete resection rate comparable to that of endoscopic submucosal dissection (ESD). We hypothesized that ESMR-L than ESD would be preferred for rectal neuroendocrine tumors. Hence, this trial aimed to verify whether ESMR-L is non-inferior to ESD in terms of histologically complete resection rate.MethodsThis is a prospective, open-label, multicenter, non-inferiority, randomized controlled trial of two parallel groups, conducted at the Shizuoka Cancer Center and 31 other institutions in Japan. Patients with a lesion endoscopically diagnosed as a rectal neuroendocrine tumor ≤ 10 mm are eligible for inclusion. A total of 266 patients will be recruited and randomized to undergo either ESD or ESMR-L. The primary endpoint is the rate of en bloc resection with histologically tumor-free margins (R0 resection). Secondary endpoints include en bloc resection rate, procedure time, adverse events, hospitalization days, total devices and agents cost, adverse event rate between groups with and without resection site closure, outcomes between expert and non-expert endoscopists, and factors associated with R0 resection failure. The sample size is determined based on the assumption that the R0 resection rate will be 95.2% in the ESD group and 95.3% in the ESMR-L group, with a non-inferiority margin of 8%. With a one-sided significance level of 0.05 and a power of 80%, 226 participants are required. Assuming a dropout rate of 15%, 266 patients will be included in this study.DiscussionThis is the first multicenter randomized controlled trial comparing ESD and ESMR-L for the R0 resection of rectal neuroendocrine tumors ≤ 10 mm. This will provide valuable information for standardizing endoscopic resection methods for rectal neuroendocrine tumors.Trial registrationJapan Registry of Clinical Trials, jRCTs042210124. Registered on Jan 6, 2022.

Computerised modified paramedian approach technique versus conventional midline approach technique of lumbar puncture: a randomised control trial protocol

IntroductionThe lumbar puncture (LP) technique is widely used for diagnostic and therapeutic purposes. In recent years, the paramedian approach technique (PAT) has gained increasing interest due to its advantages over...

Community health worker-led household screening and management of neonatal hyperbilirubinemia in rural Bangladesh: a cluster randomized control trial protocol

Background Extreme hyperbilirubinemia leading to neurologic disability and death is disproportionately higher in low- and middle-income countries (LMIC) such as Bangladesh, and is largely preventable through timely treatment. In LMICs, an estimated half of all newborns are born at home and few receive screening or treatment for hyperbilirubinemia, leading to 6 million newborns per year who need phototherapy treatment for hyperbilirubinemia but are untreated. Household screening and treatment for neonatal hyperbilirubinemia with phototherapy administered by a trained community health worker (CHW) may increase indicated treatment for neonatal hyperbilirubinemia in comparison to the existing care system in Bangladesh. Methods 530 Bangladeshi women in their second or third trimester of pregnancy from the rural community of Sakhipur, Bangladesh will be recruited for a cluster randomized trial and randomized to the intervention arm — home screening and treatment for neonatal hyperbilirubinemia — or the comparison arm to receive usual care. In the intervention arm, CHWs will provide mothers with two prenatal visits, visit newborns by 2 days of age and then daily for 3 days to measure transcutaneous bilirubin (TcB) and monitor for clinical danger signs. Newborns without danger signs but with a TcB above the treatment threshold, but &gt;15 mg/dL will be treated with light-emitting diode (LED) phototherapy at home. Newborns with danger signs or TcB ≥15 mg/dL will be referred to a hospital for treatment. Treatment rates for neonatal hyperbilirubinemia in each arm will be compared. Conclusion This study will evaluate the effectiveness of CHW-led home phototherapy to increase neonatal hyperbilirubinemia treatment rates in rural Bangladesh. LMICs are expanding access to postnatal care by using CHWs, and our work will give CHWs a curative treatment option for neonatal hyperbilirubinemia. Similar projects in other LMICs can be pursued to dramatically extend healthcare access to vulnerable newborns with hyperbilirubinemia.

Randomized controlled trial of iSupport: Comparison across seven countries

AbstractBackgroundWorld Health Organization (WHO) has developed iSupport for Dementia carers, an online program that aims to improve caregivers’ knowledge and skills, reduce emotional distress and improve the quality of life for both person with dementia and their caregivers. The program has been translated and culturally adapted in 33 countries and randomized controlled trials (RCTs) have been and are being conducted to evaluate effectiveness in Australia and Greater China, Brazil, India, the Netherlands, Portugal, the UK and Japan. We aim to compare and review RCTs protocols and key findings in those countries.MethodProtocols of seven RCTs evaluating the clinical and cost effectiveness of iSupport, and available outcomes data were reviewed and compared.ResultDelivery methods varied across countries ranging from caregivers’ self‐study using iSupport manual to a multicomponent intervention that engaged caregivers in iSupport and provided concomitant support from peers and facilitators. Control conditions also varied allocating the participants to either a waiting list or a control intervention. Sample sizes were between 42 to 390. Data were collected at three time‐points: baseline, three and six or nine months post baseline. The primary outcome was one or a combination of burden, depression, anxiety, health‐related quality of life, and stress. Secondary outcomes included depression, anxiety, quality of life, care recipient outcomes, positive aspects of caregiving, person‐centered attitude, self‐efficacy, mastery, resilience and dementia knowledge. In India, significant improvement was only seen in caregivers' person‐centered attitude towards persons with dementia in the iSupport group. Findings from interim data analysis in Australia and Greater China indicate that the iSupport group significantly improved the mental health component of quality of life, self‐efficacy, and reactions to care recipients’ memory and behavioural problems. The retention rate at 3 months were 36.42% in India, 82% in the UK, 85% in Australia and Greater China and 90.1% in Japan (interim analysis).ConclusionSome of the RCTs are still ongoing and results are expected soon. Preliminary data suggest that iSupport could be beneficial for both caregivers and recipients.

Real-World Outcomes of Medicare Fee-for-Service Beneficiaries Meeting the Eligibility Criteria for the DREAMM-7 and DREAMM-8 Clinical Trials

Introduction: Belantamab mafodotin (belamaf), an investigational first-in-class B-cell maturation antigen-binding antibody-drug conjugate, has demonstrated deep and durable responses as a monotherapy in patients with relapsed/refractory multiple myeloma (RRMM) in the DREAMM-2 and DREAMM-3 trials. Two randomized controlled trials (RCTs) exploring the use of belamaf in combination therapy are ongoing in patients with RRMM treated with at least 1 prior line of therapy (2L+). DREAMM-7 is evaluating the efficacy and safety of belamaf in combination with bortezomib and dexamethasone versus daratumumab in combination with bortezomib and dexamethasone. DREAMM-8 is evaluating the efficacy and safety of belamaf in combination with pomalidomide and dexamethasone versus pomalidomide in combination with bortezomib and dexamethasone. The present study aimed to provide real-world context for DREAMM-7 and DREAMM-8 trial results by reporting treatment outcomes of Medicare Fee-for-Service (FFS) patients with characteristics that meet the inclusion/exclusion criteria for each trial. Methods: A retrospective database analysis was conducted to develop trial-like cohorts (one per trial) using the 100% sample from Medicare FFS administrative claims data spanning 2016-2020. Inclusion/exclusion criteria from each RCT protocol included the presence of an MM diagnosis (based on an ICD-9-CM or ICD-10-CM diagnosis code for MM), ≥1 prior line of therapy (prior lenalidomide treatment required for the DREAMM-8 cohort), and other exclusion criteria related to renal, liver, and cardiovascular function. These criteria were used to identify patients in the Medicare FFS database who would be eligible for trial enrollment. Both RCT protocols restricted the overall study populations to ≤50% of patients with at least 2 prior lines of therapy (3L+). Accordingly, random sampling without replacement was applied across eligible Medicare patient lines of therapy to generate cohorts composed of 50% 2L RRMM patients and 50% 3L+ RRMM patients. Index date was the date the randomized line of therapy was initiated. Overall survival (OS) for each cohort was estimated using time from index date until death. Real-world progression-free survival (rwPFS) for each cohort was estimated as the time from index date until next treatment or death. Results: Overall, 1,911 and 1,280 patients met the DREAMM-7 and DREAMM-8 eligibility criteria, respectively. Following random sampling, the analysis cohorts were composed of 1,232 patients (DREAMM-7) and 1,066 patients (DREAMM-8). For the DREAMM-7 trial-like cohort, median rwPFS was 13.6 months and median OS was 29.6 months(Figure). The most commonly used regimens in this cohort were lenalidomide +/- steroids (21.3%), bortezomib +/- steroids (14.4%), and bortezomib + lenalidomide +/- steroids (8.9%). In the DREAMM-8 trial-like cohort, median rwPFS was 13.2 months and median OS was 30.8 months (Figure). In this cohort, the most common regimens were lenalidomide +/- steroids (21.1%), bortezomib +/- steroids (12.9%), and pomalidomide +/- steroids (8.3%). Over a third of patients in the DREAMM-8 trial-like cohort were retreated with lenalidomide. Conclusions: Real-world outcomes of Medicare FFS patients with RRMM eligible for DREAMM-7 and DREAMM-8 were suboptimal: 57% and 56% died within 3 years of entry into their trial-like cohort, respectively, and median rwPFS was around 1 year for both cohorts. Lenalidomide +/- steroids and bortezomib +/- steroids were most commonly used in each cohort. Retreatment with lenalidomide was common in the DREAMM-8 trial-like cohort. These suboptimal outcomes and frequent retreatment demonstrate a substantial need for new effective treatment modalities to improve patient outcomes and provide further treatment choice in the 2L+ RRMM setting. Funding: GSK (Study 209838). Drug linker technology licensed from Seagen Inc.; monoclonal antibody produced using POTELLIGENT Technology licensed from BioWa.

Mobility and strength training with and without protein supplements for pre-frail or frail older adults with low protein intake: the Maximising Mobility and Strength Training (MMoST) feasibility randomised controlled trial protocol

Background Frailty is a common syndrome affecting older people and puts them at risk of hospitalisation, needing care or death. First signs of frailty include reduced muscle strength and mobility decline. A key cause of mobility decline as we age is sarcopenia (age related reduction in muscle strength and mass). Poor nutrition contributes to sarcopenia. A shortfall in protein is associated with reduced muscle mass and strength. This may be due to inadequate intake but also because older people have higher protein needs, especially those with multimorbidity. We need to develop effective treatment to reduce or slow the onset of frailty and mobility decline. Exercise is a recommended treatment. Protein supplements to address the shortfall in protein have the potential to enhance the benefit of regular exercise in frail or pre-frail older adults. This has yet to be definitively demonstrated. Aim To establish the feasibility of conducting an RCT evaluating mobility and strength training with or without protein supplements for people over 60 years old who are frail or pre-frail with a low protein intake. Methods A multicentre, parallel, 2-group, feasibility RCT. Participants (recruitment target = 50) with problems walking, low protein intake and classified as frail or pre-frail will be recruited from four NHS Physiotherapy community services. Participants will be randomised (secure computer-generated: 1:1) to receive 24 weeks of mobility and strength training (delivered in 16 group sessions plus home exercises) or 24 weeks of mobility and strength training with daily protein supplements. Primary feasibility objectives are to estimate 1) ability to screen and recruit eligible participants, 2) intervention fidelity, adherence, and tolerance and 3) retention of participants at follow up. Secondary objectives are to 1) test data collection procedures, 2) assess data completeness and 3) confirm sample size calculation for a definitive RCT. Registration ISRCTN Registry (ISRCTN30405954; 18/10/2022).

Adaptive yoga versus low-impact exercise for adults with chronic acquired brain injury: a pilot randomized control trial protocol.

Each year, millions of Americans sustain acquired brain injuries (ABI) which result in functional impairments, such as poor balance and autonomic nervous system (ANS) dysfunction. Although significant time and energy are dedicated to reducing functional impairment in acute phase of ABI, many individuals with chronic ABI have residual impairments that increase fall risk, decrease quality of life, and increase mortality. In previous work, we have found that yoga can improve balance in adults with chronic (i.e., ≥6 months post-injury) ABI. Moreover, yoga has been shown to improve ANS and brain function in healthy adults. Thus, adults with chronic ABI may show similar outcomes. This protocol details the methods used to examine the effects of a group yoga program, as compared to a group low-impact exercise, on primary and secondary outcomes in adults with chronic ABI. This study is a single-blind randomized controlled trial comparing group yoga to group low-impact exercise. Participants must be ≥18 years old with chronic ABI and moderate balance impairments. Group yoga and group exercise sessions occur twice a week for 1 h for 8 weeks. Sessions are led by trained adaptive exercise specialists. Primary outcomes are balance and ANS function. Secondary outcomes are brain function and structure, cognition, quality of life, and qualitative experiences. Data analysis for primary and most secondary outcomes will be completed with mixed effect statistical methods to evaluate the within-subject factor of time (i.e., pre vs. post intervention), the between-subject factor of group (yoga vs. low-impact exercise), and interaction effects. Deductive and inductive techniques will be used to analyze qualitative data. Due to its accessibility and holistic nature, yoga has significant potential for improving balance and ANS function, along with other capacities, in adults with chronic ABI. Because there are also known benefits of exercise and group interaction, this study compares yoga to a similar, group exercise intervention to explore if yoga has a unique benefit for adults with chronic ABI.Clinical trial registration:ClinicalTrials.gov, NCT05793827. Registered on March 31, 2023.

Effect of breather device on respiratory muscle strength and quality of life in coronary artery bypass grafting patients: A randomised control trial protocol

Coronary artery bypass surgery is widely spread and done for multiple vessel disease, and still a well-established therapy option for coronary artery disease. Reduced respiratory muscle strength has been linked to decreased functional capacity in heart surgery, which has been linked to a prolonged recovery period for lung functions and onset of physical deconditioning, which can last for more than a week. Other common postoperative complications include urinary tract infections, renal failure, limb ischemia, pleural effusion, and hematologic abnormalities. Alterations in lung capacity and size, malfunction of the alveoli, decrease in the central respiratory stimulus, and mechanical issues with thoracic function are all brought on by respiratory consequences. Therefore, to prevent or reduce postoperative pulmonary complications, it is typically advised that patients who have had heart surgery engage in breathing exercises and chest physical therapy. The Breather is a breathing apparatus that uses resistance breathing through various-sized orifices to strengthen respiratory muscles. In addition to healthy people and athletes, breather devices can be used for training, therapy, prevention, or rehabilitation of a variety of pulmonary and other disorders. As there is limited literature showing the efficacy of a breather device in coronary artery bypass grafting (CABG) patients, therefore a need for a study to find the efficacy of a breather device in assessing strength of respiratory muscle and quality of life in CABG patients. Treatment will be given for three weeks with five sessions per week twice a day. Pre- and post-treatment outcomes will be noted. In this study, results are expected to prove the Breather device is as effective or more effective than conventional chest physiotherapy for refining respiratory muscle strength and quality of life. CTRI registration: CTRI/2023/05/053052

CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials

BackgroundCommunityRx is an evidence-based social care intervention delivered to family and friend caregivers (“caregivers”) at the point of healthcare to address health-related social risks (HRSRs). Two CommunityRx randomized controlled trials (RCTs) are being fielded concurrently on Chicago’s South Side, a predominantly African American/Black community. CommunityRx-Hunger is a double-blind RCT enrolling caregivers of hospitalized children. CommunityRx-Dementia is a single-blind RCT enrolling caregivers of community-residing people with dementia. RCTs with caregivers face recruitment barriers, including caregiver burden and lack of systematic strategies to identify caregivers in clinical settings. COVID-19 pandemic-related visitor restrictions exacerbated these barriers and prompted the need for iteration of the protocols from in-person to remote operations. This study describes these protocols and methods used for successful iteration to overcome barriers.Methods and findingsCommunityRx uses individual-level data to generate personalized, local community resource referrals for basic, health and caregiving needs. In early 2020, two in-person RCT protocols were pre-tested. In March 2020, when pandemic conditions prohibited face-to-face clinical enrollment, both protocols were iterated to efficient, caregiver-centered remote operations. Iterations were enabled in part by the Automated Randomized Controlled Trial Information-Communication System (ARCTICS), a trial management system innovation engineered to integrate the data collection database (REDCap) with community resource referral (NowPow) and SMS texting (Mosio) platforms. Enabled by engaged Community Advisory Boards and ARCTICS, both RCTs quickly adapted to remote operations. To accommodate these adaptations, launch was delayed until November (CommunityRx-Hunger) and December (CommunityRx-Dementia) 2020. Despite the delay, 65% of all planned participants (CommunityRx-Hunger n = 417/640; CommunityRx-Dementia n = 222/344) were enrolled by December 2021, halfway through our projected enrollment timeline. Both trials enrolled 13% more participants in the first 12 months than originally projected for in-person enrollment.DiscussionOur asset-based, community-engaged approach combined with widely accessible institutional and commercial information technologies facilitated rapid migration of in-person trials to remote operations. Remote or hybrid RCT designs for social care interventions may be a viable, scalable alternative to in-person recruitment and intervention delivery protocols, particularly for caregivers and other groups that are under-represented in traditional health services research.Trial registrationClinicalTrials.gov: CommunityRx-Hunger (NCT04171999, 11/21/2019); CommunityRx for Caregivers (NCT04146545, 10/31/2019).

Safety and care of no fasting prior to catheterization laboratory procedures: a non-inferiority randomized control trial protocol (SCOFF trial).

Cardiac catheterization procedures are typically performed with local anaesthetic and proceduralist guided sedation. Various fasting regimens are routinely implemented prior to these procedures, noting the absence of prospective evidence, aiming to reduce aspiration risk. However, there are additional risks from fasting including patient discomfort, intravascular volume depletion, stimulus for neuro-cardiogenic syncope, glycaemic outcomes, and unnecessary fasting for delayed/cancelled procedures. This is an investigator-initiated, multicentre, randomized trial with a prospective, open-label, blinded endpoint (PROBE) assessment based in New South Wales, Australia. Patients will be randomized 1:1 to fasting (6 h solid food and 2 h clear liquids) or to no fasting requirements. The primary outcome will be a composite of hypotension, hyperglycaemia, hypoglycaemia, and aspiration pneumonia. Secondary outcomes will include patient satisfaction, contrast-induced nephropathy, new intensive care admission, new non-invasive or invasive ventilation requirement post procedure, and 30-day mortality and readmission. This is a pragmatic and clinically relevant randomised trial designed to compare fasting verse no fasting prior to cardiac catheterisation procedures. Routine fasting may not reduce peri-procedural adverse events in this setting.

Is older still good, or even better? Evaluation of possibility of using Miller laryngoscope for intubation in adults and comparison with the most widely used Macintosh laryngoscope. Protocol of a crossover randomized control trial

BackgroundMacintosh laryngoscope is the most widely used laryngoscope for intubation. In some patients, e.g. with flaccid, drooping, aplastic epiglottis, usage of this laryngoscope, or even videolaryngoscopes, may not provide visualization of a glottis. Elevation of the laryngopharynx, like in intubation with Miller laryngoscope, may significantly improve intubating conditions. MethodsAn anaesthesiologist with over 20 years of experience will perform direct laryngoscopy with randomly chosen Miller or Macintosh blade, evaluating the visibility of rima glottidis with Cormack-Lehane classification and POGO score with and without external laryngeal pressure. Then the second evaluation of glottis with other blade type will be obtained and the patient will be intubated. Comparison of the rima glottidis visibility when using both blades will be the primary endpoint of the study. The secondary endpoints consist of: demonstrating whether there is a group of adult patients in whom the use of the Miller blade associated with better vocal cord visibility may be predicted based on an anesthesiological examination, and whether external laryngeal pressure improves vocal cord visualization more when using the Miller blade compared with the Macintosh blade. Sample sizeWe performed minimal sample size calculations based on the data derived from the first 60 patients. We assessed the minimal sample size to obtain the alpha of 5 % and power of 90 %. We decide to enroll at least 286 patients. Discussionthis will be the first trial assessing Miller and Macintosh blades in the same population of adult patients. It will determine group of patients in whom Miller laryngoscope will provide better visualization of rima glottidis than Macintosh blade and associated technique, diminishing rate of prolonging intubations and reducing possible aftermaths of hypoxia.

A feasibility randomized controlled trial testing the use of indocyanine green fluorescence image-guidance in liver surgery compared to standard liver surgery alone in reducing microscopic positive tumor margin resection rate with an embedded qualitative study: the I-FIGS study protocol

Abstract Indocyanine green fluorescence image-guidance (I-FIGS) is gaining global popularity in liver surgery for various applications. However, its true clinical value in reducing microscopic positive margins (R1-resection rate) remains uncertain. To address this, a multi-center randomized controlled trial (RCT) comparing I-FIGS with standard liver surgery is needed. However, due to a lack of essential information on potential R1 reduction rate, sample size, methodology, intervention delivery and patient experience, a feasibility RCT protocol has been developed to determine the viability of conducting a full-scale RCT. The aim of the study is to conduct a feasibility RCT (fRCT) with an embedded qualitative study to gather all the necessary information for a full-scale RCT. Adult patients undergoing elective liver surgery for colorectal liver metastasis (CRLMs), hepatocellular carcinoma (HCC) or peripheral cholangiocarcinoma will be eligible for the study. Forty patients will be randomly assigned to either the control group (standard liver surgery) or the intervention group (standard liver surgery + I-FIGS). Patients in the I-FIGS group will receive intravenous injection of 0.03–0.05 mg/kg indocyanine green (ICG) dye 2–4 hours before the surgery. Data will be collected on demographics, screening, recruitment and retention rates, adherence to study methods, intraoperative details, postoperative histology, and experiences of both surgeons and patients. Interviews will be conducted with selected patients and surgeons to explore their experiences with the intervention. The protocol has been approved by the West-Midlands-Solihull Research Ethics Committee and registered with ClinicalTrials.gov (NCT05616039). The results will be disseminated through academic publications, congresses, newsletters and other platforms.

Effectiveness of education on linear programmed dietary plan using locally available food on energy intake among HIV-infected children aged 2 to 5 years in Simiyu region: A cluster randomized control trial protocol

Background: Most of human immunodeficiency virus (HIV) infected children have decreased energy intake due to loss of appetite which resulted in weight loss. The diets of many HIV-infected children do not meet the recommended levels of energy intake required. However, caregivers with poor nutrition knowledge are more likely to feed their children with low-quality and diverse foods and at a lower frequency than recommended. This study aims to test the effectiveness of education on the linear programmed dietary plan using locally available food on energy intake of HIV-infected children in Tanzania mainland. Methods: The study will be a cluster randomized control trial study designed with both intervention and control arms and will use a quantitative approach. Care and treatment center will be the unit of randomization. The study will involve 200 asymptomatic HIV-infected children aged 2 to 5 years. The children will be randomly allocated into the intervention and control arm. The intervention will be implemented for 3 months. Participants from all groups will be assessed nutrition knowledge and attitude as well as 24-hour recall at baseline and end line. Education on how to use the energy-dense dietary plan developed by using linear programming techniques will be provided to the intervention group. The main outcome measures will be changes in knowledge, attitude, and energy intake in the intervention group compared with the control group. An unpaired t test will be used to establish the effectiveness of the intervention. A P value of less than .05 will be considered statistically significant. Discussion: The results of this study will provide evidence of the effectiveness of linear programmed dietary plan education on energy intake in community settings of rural Tanzania. It will form the basis for strengthening diet intake among HIV-infected children to improve energy intake using locally available food.

Efficacy of lung boost device on pulmonary function and chest expansion in pleural effusion patient: a randomized control trial protocol

Background: The respiratory system is consisting of alveoli, bronchioles, pleura etc. The pleura is the name for the layer of tissue that is thin covers every lung and folds to the back side and creates border of the cavity of chest. Pleural effusion medically is termed for an accumulation of fluid above the required amount in the pleural space. Firstly, while evaluating the subjects with effusion of pleura is to determine if it is an exudate or a transudate. The factors that are pathophysiological may be clinically significant and play role in differentiating trait of effusion of pleura -transudate vs. exudates-include oncotic pressure that is low, increase in pressure of pulmonary capillary, increased permeability, obstruction of lymphatic system, and lowered pressure between pleura. Aim: To find the efficacy of the lung boost device on pulmonary functions and chest expansion in pleural effusion patient. Methods: A total of 70 of participants with pleural effusion would be taken in the study and they are separated in two groups 35 participants in single group. Group A would be having lung boost device and group B would be treated with Conventional Physiotherapy program which will be included in both the groups. Treatment will last for two weeks with six sessions a week. Pre- and post-intervention pulmonary function test and chest expansion would be found out and would be sent for the analysis. Expected results: The results of the study are expected to prove lung boost device is more effective than conventional physiotherapy. So that it can help in increasing expansion of chest and function of pulmonary system of patients with effusion of pleura.