Comparative Effectiveness of Pediatric Integrative Medicine: A Pragmatic Cluster-Controlled Trial.
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SUBMITTER: Vohra S
PROVIDER: S-EPMC8072575 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:INTRODUCTION:0.9% saline and Ringer's lactate are the two most common resuscitation crystalloid fluids. 0.9% saline may lead to hyperchloraemic metabolic acidosis and may be associated with impaired kidney function and death. Few large multicentre randomised trials have been conducted to evaluate the effect of these two fluids on clinically important outcomes. METHODS:FLUID is a pragmatic pilot cluster randomised crossover trial in which four hospitals will be randomised to normal saline or Ringer's lactate for 14 weeks, then crossover to the alternative fluid for the subsequent 14 weeks after 1 to 3?week transition. With waiver of informed consent, all adult and paediatric patients admitted to participating sites will be included in the FLUID trial except for neonates. Primary feasibility outcome is study fluid protocol adherence (target:?80%). Secondary feasibility outcomes include time to research ethics board (REB) approval and readiness to trial initiation (?3 months from REB submission and approval). Primary (composite of death or re-admission to hospital in first 90 days of index hospitalisation) and secondary clinical outcomes for the future large FLUID trial will be described. Protocol adherence will be collected by site at specified time points. All clinical data will be obtained at patient level through provincial health administrative data held at the Institute for Clinical Evaluative Sciences (ICES). Event rates for the primary and secondary outcomes will be described using frequencies and proportions with 95% CIs. Intracluster and interperiod correlation coefficients will be calculated from population-level data available at ICES. ETHICS AND DISSEMINATION:The study protocol has been approved by the Ottawa Health Science Research Ethics Board. The FLUID pilot will determine feasibility, and ICES data across all potential sites in Ontario will allow calculation of sample size parameter estimates to inform the design and implementation of the large trial. TRIAL REGISTRATION NUMBER:NCT02721485; Pre-results.
| S-EPMC6112401 | biostudies-literature
Project description:ObjectiveTo evaluate the effectiveness of different brief intervention strategies at reducing hazardous or harmful drinking in primary care. The hypothesis was that more intensive intervention would result in a greater reduction in hazardous or harmful drinking.DesignPragmatic cluster randomised controlled trial.SettingPrimary care practices in the north east and south east of England and in London.Participants3562 patients aged 18 or more routinely presenting in primary care, of whom 2991 (84.0%) were eligible to enter the trial: 900 (30.1%) screened positive for hazardous or harmful drinking and 756 (84.0%) received a brief intervention. The sample was predominantly male (62%) and white (92%), and 34% were current smokers.InterventionsPractices were randomised to three interventions, each of which built on the previous one: a patient information leaflet control group, five minutes of structured brief advice, and 20 minutes of brief lifestyle counselling. Delivery of the patient leaflet and brief advice occurred directly after screening and brief lifestyle counselling in a subsequent consultation.Main outcome measuresThe primary outcome was patients' self reported hazardous or harmful drinking status as measured by the alcohol use disorders identification test (AUDIT) at six months. A negative AUDIT result (score <8) indicated non-hazardous or non-harmful drinking. Secondary outcomes were a negative AUDIT result at 12 months, experience of alcohol related problems (alcohol problems questionnaire), health utility (EQ-5D), service utilisation, and patients' motivation to change drinking behaviour (readiness to change) as measured by a modified readiness ruler.ResultsPatient follow-up rates were 83% at six months (n=644) and 79% at 12 months (n=617). At both time points an intention to treat analysis found no significant differences in AUDIT negative status between the three interventions. Compared with the patient information leaflet group, the odds ratio of having a negative AUDIT result for brief advice was 0.85 (95% confidence interval 0.52 to 1.39) and for brief lifestyle counselling was 0.78 (0.48 to 1.25). A per protocol analysis confirmed these findings.ConclusionsAll patients received simple feedback on their screening outcome. Beyond this input, however, evidence that brief advice or brief lifestyle counselling provided important additional benefit in reducing hazardous or harmful drinking compared with the patient information leaflet was lacking.Trial registrationCurrent Controlled Trials ISRCTN06145674.
| S-EPMC3541471 | biostudies-literature
Project description:BackgroundTraditional Korean medicine (TKM) has been employed for the treatment of children with cerebral palsy in Korea; however, the addition of TKM to usual rehabilitation (UR) treatment is hindered by insufficient evidence of clinical improvement with TKM in patients with cerebral palsy. In this study, we will evaluate the effectiveness and safety of integrative medicine rehabilitation (IMR) for cerebral palsy through a randomized controlled clinical study.MethodsEighty children (2-6 years old) diagnosed with cerebral palsy will be recruited and randomly divided into groups A and B. Patients in group A will receive IMR with UR, while those in group B will receive only UR during weeks 1-12 of the study. IMR includes acupuncture treatment (head and limb acupuncture) three times a week and the administration of herbal medicine (Yukgunza-tang and Yukmijihwang-tang extracts) twice a day in parallel with UR. Evaluations will be conducted at the beginning of the study and at 12 and 24 weeks (follow-up). The primary outcome is the Gross Motor Function Measure-88 score, and the secondary outcomes are the scores for the Goal Attainment Scale, Korean Bayley Scales of Infant Development III, and the Pediatric Quality of Life Inventory, and adverse events.DiscussionThis will be the first pragmatic randomized controlled trial to evaluate the efficacy and safety of IMR in children with cerebral palsy in Korea. The results will help to demonstrate if IMR is an effective therapeutic approach for cerebral palsy.Trial registrationMinistry of Food and Drug Safety 31361 ( http://www.mfds.go.kr ). Registered on 29 June 2017. Clinical Research Information Service KCT0002620 ( https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=9819 ). Registered on 29 December 2017.
| S-EPMC7430116 | biostudies-literature
Project description:OBJECTIVE:To evaluate the clinical and cost effectiveness of a group-based memory rehabilitation programme for people with traumatic brain injury. DESIGN:Multicentre, pragmatic, observer-blinded, randomized controlled trial in England. SETTING:Community. PARTICIPANTS:People with memory problems following traumatic brain injury, aged 18-69?years, able to travel to group sessions, communicate in English, and give consent. INTERVENTIONS:A total of 10 weekly group sessions of manualized memory rehabilitation plus usual care (intervention) vs. usual care alone (control). MAIN MEASURES:The primary outcome was the patient-reported Everyday Memory Questionnaire (EMQ-p) at six months post randomization. Secondary outcomes were assessed at 6 and 12?months post randomization. RESULTS:We randomized 328 participants. There were no clinically important differences in the primary outcome between arms at six-month follow-up (mean EMQ-p score: 38.8 (SD 26.1) in intervention and 44.1 (SD 24.6) in control arms, adjusted difference in means: -2.1, 95% confidence interval (CI): -6.7 to 2.5, p?=?0.37) or 12-month follow-up. Objectively assessed memory ability favoured the memory rehabilitation arm at the 6-month, but not at the 12-month outcome. There were no between-arm differences in mood, experience of brain injury, or relative/friend assessment of patient's everyday memory outcomes, but goal attainment scores favoured the memory rehabilitation arm at both outcome time points. Health economic analyses suggested that the intervention was unlikely to be cost effective. No safety concerns were raised. CONCLUSION:This memory rehabilitation programme did not lead to reduced forgetting in daily life for a heterogeneous sample of people with traumatic brain injury. Further research will need to examine who benefits most from such interventions.
| S-EPMC6585159 | biostudies-literature
Project description:BackgroundCurrent treatment options for chronic pain and depression are largely medication-based, which may cause adverse side effects. Integrative Medical Group Visits (IMGV) combines mindfulness techniques, evidence based integrative medicine, and medical group visits, and is a promising adjunct to medications, especially for diverse underserved patients who have limited access to non-pharmacological therapies.ObjectiveDetermine the effectiveness of IMGV compared to a Primary Care Provider (PCP) visit in patients with chronic pain and depression.Design9-week single-blind randomized control trial with a 12-week maintenance phase (intervention-medical groups; control-primary care provider visit).SettingAcademic tertiary safety-net hospital and 2 affiliated federally-qualified community health centers.Participants159 predominantly low income racially diverse adults with nonspecific chronic pain and depressive symptoms.InterventionsIMGV intervention- 9 weekly 2.5 hour in person IMGV sessions, 12 weeks on-line platform access followed by a final IMGV at 21 weeks.MeasurementsData collected at baseline, 9, and 21 weeks included primary outcomes depressive symptoms (Patient Health Questionnaire 9), pain (Brief Pain Inventory). Secondary outcomes included pain medication use and utilization.ResultsThere were no differences in pain or depression at any time point. At 9 weeks, the IMGV group had fewer emergency department visits (RR 0.32, 95% CI: 0.12, 0.83) compared to controls. At 21 weeks, the IMGV group reported reduction in pain medication use (Odds Ratio: 0.42, CI: 0.18-0.98) compared to controls.LimitationsAbsence of treatment assignment concealment for patients and disproportionate group attendance in IMGV.ConclusionResults demonstrate that low-income racially diverse patients will attend medical group visits that focus on non-pharmacological techniques, however, in the attention to treat analysis there was no difference in average pain levels between the intervention and the control group.Trial registrationclinicaltrials.gov NCT02262377.
| S-EPMC6919581 | biostudies-literature
Project description:BACKGROUND:Alcohol misuse is common in people attending emergency departments (EDs) and there is some evidence of efficacy of alcohol screening and brief interventions (SBI). This study investigated the effectiveness of SBI approaches of different intensities delivered by ED staff in nine typical EDs in England: the SIPS ED trial. METHODS AND FINDINGS:Pragmatic multicentre cluster randomized controlled trial of SBI for hazardous and harmful drinkers presenting to ED. Nine EDs were randomized to three conditions: a patient information leaflet (PIL), 5 minutes of brief advice (BA), and referral to an alcohol health worker who provided 20 minutes of brief lifestyle counseling (BLC). The primary outcome measure was the Alcohol Use Disorders Identification Test (AUDIT) status at 6 months. Of 5899 patients aged 18 or more presenting to EDs, 3737 (63·3%) were eligible to participate and 1497 (40·1%) screened positive for hazardous or harmful drinking, of whom 1204 (80·4%) gave consent to participate in the trial. Follow up rates were 72% (n?=?863) at six, and 67% (n?=?810) at 12 months. There was no evidence of any differences between intervention conditions for AUDIT status or any other outcome measures at months 6 or 12 in an intention to treat analysis. At month 6, compared to the PIL group, the odds ratio of being AUDIT negative for brief advice was 1·103 (95% CI 0·328 to 3·715). The odds ratio comparing BLC to PIL was 1·247 (95% CI 0·315 to 4·939). A per protocol analysis confirmed these findings. CONCLUSIONS:SBI is difficult to implement in typical EDs. The results do not support widespread implementation of alcohol SBI in ED beyond screening followed by simple clinical feedback and alcohol information, which is likely to be easier and less expensive to implement than more complex interventions. TRIAL REGISTRATION:Current Controlled Trials ISRCTN 93681536.
| S-EPMC4070907 | biostudies-literature
Project description:ObjectivesNormal saline (NS) and Ringer's lactate (RL) are the most common crystalloids used for fluid therapy. Despite evidence of possible harm associated with NS (eg, hyperchloremic metabolic acidosis, impaired kidney function and death), few large multi-centre randomised trials have evaluated the effect of these fluids on clinically important outcomes. We conducted a pilot trial to explore the feasibility of a large trial powered for clinically important outcomes.DesignFLUID was a pragmatic pilot cluster randomised cross-over trial.SettingFour hospitals in the province of Ontario, Canada PARTICIPANTS: All hospitalised adult and paediatric patients with an incident admission to the hospital over the course of each study period.InterventionsA hospital wide policy/strategy which stocked either NS or RL throughout the hospital for 12 weeks before crossing over to the alternate fluid for the subsequent 12 weeks.Primary and secondary outcome measuresThe primary feasibility outcome was study fluid protocol adherence. Secondary feasibility outcomes included time to Research Ethics Board (REB) approval and trial initiation. Primary (composite of death or re-admission to hospital in first 90 days of index hospitalisation) and secondary clinical outcomes were analysed descriptively.ResultsAmong 24 905 included patients, mean age 59.1 (SD 20.5); 13 977 (56.1%) were female and 21 150 (85.0%) had medical or surgical admitting diagnoses. Overall, 96 821 L were administered in the NS arm, and 78 348 L in the RL arm. Study fluid adherence to NS and RL was 93.7% (site range: 91.6%-98.0%) and 79.8% (site range: 72.5%-83.9%), respectively. Time to REB approval ranged from 2 to 48 days and readiness for trial initiation from 51 to 331 days. 5544 (22.3%) patients died or required hospital re-admission in the first 90 days.ConclusionsThe future large trial is feasible. Anticipating and addressing logistical challenges during the planning stages will be imperative.Trial registration numberNCT02721485.
| S-EPMC9900065 | biostudies-literature
Project description:A model for integrative medicine (IM) adapted to Swedish primary care was previously developed. The aim of this study was to explore the feasibility of a pragmatic randomised clinical trial to investigate the effectiveness of the IM model versus conventional primary care in the management of patients with non-specific back/neck pain. Specific objectives included the exploration of recruitment and retention rates, patient and care characteristics, clinical differences and effect sizes between groups, selected outcome measures and power calculations to inform the basis of a full-scale trial.Eighty patients with back/neck pain of at least two weeks duration were randomised to the two types of care. Outcome measures were standardised health related quality of life (the eight domains of SF-36) complemented by a set of exploratory "IM tailored" outcomes targeting self-rated disability, stress and well-being (0-10 scales); days in pain (0-14); and the use of analgesics and health care over the last two weeks (yes/no). Data on clinical management were derived from medical records. Outcome changes from baseline to follow-up after 16 weeks were used to explore the differences between the groups.Seventy-five percent (80/107) of screened patients in general practice were eligible and feasible to enroll into the trial. Eighty-two percent (36/44) of the integrative and 75% (27/36) of the conventional care group completed follow-up after 16 weeks. Most patients had back/neck pain of at least three months duration. Conventional care typically comprised advice and prescription of analgesics, occasionally complemented with sick leave or a written referral to physiotherapy. IM care generally integrated seven treatment sessions from two different types of complementary therapies with conventional care over ten weeks. The study was underpowered to detect any statistically significant differences between the groups. One SF-36 domain showed a clinically relevant difference between groups that was also supported by a small distribution based effect size, i.e. vitality (-7.3 points, Cohen's d -0.34) which was in favour of IM. There was a clinical trend between groups showing that IM contributed to less use of prescription and non-prescription analgesics (-11.7 and - 9.7 percent units respectively) compared to conventional care. Exploring clinically relevant differences and the SF-36 as the basis for a main outcome measure showed that the sample sizes needed per arm to adequately power a full-scale trial depended on the target domain, i.e. ranging from 60 (vitality) to 339 (role emotion).This pilot study investigated the implementation of IM in the primary care management of non-specific back and neck pain. Recruiting patients and implementing IM in routine clinical practice was feasible. The results warrant further exploration into different perspectives and relevant combinations of outcome measures including the use of health resources, drugs and cost-effectiveness to help understand the relevance of IM in primary care. Future research should prioritize larger scale studies considering variability, pain duration and small to moderate treatment effects.Clinical trials NCT00565942.
| S-EPMC2749805 | biostudies-literature
Project description:ObjectiveTo evaluate the effectiveness of a traditional didactic session (TDS) as compared to a self-paced, interactive, multimedia module (SPM) on the application of evidence-based medicine (EBM) skills among medical students during their inpatient pediatric rotation.MethodsWe conducted a randomized controlled trial from June, 2017 to June, 2018 at a quaternary care children's hospital. Students were randomized to TDS or SPM during each 2-week block. All students completed a critical appraisal tool (CAT) of evidence related to a clinical question in a standardized appraisal form and self-reflected about the EBM process. The primary outcome was the numeric score of the CAT derived by using the validated Fresno tool. Secondary outcomes of knowledge, attitudes, confidence, and self-reported behaviors related to EBM were measured using validated surveys. Statistical analysis was performed using Student's t test for CAT scores and mixed-model procedure (PROC MIXED), with subject as random effect and time as repeated measure for the secondary outcomes.ResultsOne hundred twenty-seven clerkship students were included. Overall, there was no significant difference in mean CAT scores for TDS (n = 59) versus SPM (n = 66) groups (90.3 vs 92.0, P = .65). There were no significant differences between SPM and TDS groups for knowledge (P = .66), attitudes (P = .97), confidence (P = .55), and accessing evidence (P = .27). Both groups showed significant gains in knowledge, attitudes, confidence, and accessing evidence from baseline to postcourse. Improvements in knowledge and confidence were sustained at 3-months.ConclusionA SPM learning module is as effective as a TDS module for application of EBM concepts and knowledge to patient care.
| S-EPMC7525332 | biostudies-literature
Project description:The study evaluated the implementation fidelity and effectiveness of KiVa, an evidence-based program that aims to prevent and address bullying in schools, with a particular emphasis on changing the role of bystanders. The study was a two-arm waitlist control cluster randomized controlled trial in which 22 primary schools (clusters) (N?=?3214 students aged 7-11) were allocated using a 1:1 ratio to intervention (KiVa; 11 clusters, n?=?1588 students) and a waitlist control (usual school provision; 11 clusters, n?=?1892 children)). The trial statistician (but not schools or researchers) remained blind to allocation status. The outcomes were as follows: student-reported victimization (primary outcome) and bullying perpetration; teacher-reported child behavior and emotional well-being; and school absenteeism (administrative records). Implementation fidelity was measured using teacher-completed online records (for class lessons) and independent researcher observations (for school-wide elements). Outcome analyses involved 11 intervention schools (n?=?1578 children) and 10 control schools (n?=?1636 children). There was no statistically significant effect on the primary outcome of child-reported victimization (adjusted intervention/control OR 0.76; 95% CI 0.55 to 1.06; p?=?0.11) or on the secondary outcomes. The impact on victimization was not moderated by child gender, age, or victimization status at baseline. Lesson adherence was good but exposure (lesson length) was lower than the recommended amount, and there was considerable variability in the implementation of whole school elements. The trial found insufficient evidence to conclude that KiVa had an effect on the primary outcome. A larger trial of KiVa in the UK is warranted, however, with attention to issues regarding implementation fidelity. Trial registration: Current Controlled Trials ISRCTN23999021 Date 10-6-13.
| S-EPMC7305088 | biostudies-literature