Pragmatic Randomized Controlled Trial Research Articles

Quality of life measures and cost analysis of biologic versus synthetic mesh for ventral hernia repair: The Preventing Recurrence in Clean and Contaminated Hernias randomized clinical trial

BackgroundAlthough the most durable method for ventral hernia repairs involves using mesh, whether to use biologic mesh versus synthetic mesh remains controversial. This study aimed to compare synthetic and biologic meshes with respect to patient-reported quality of life scores and costs after ventral hernia repair surgeries. MethodsThis study is part of the Preventing Recurrence in Clean and Contaminated Hernias (PRICE) pragmatic randomized control trial conducted from March 2014 through October 2018. Patients were randomized 1:1 to undergo ventral hernia repair using either a biologic or synthetic mesh. The coprimary outcomes were 2-year changes in Visual Analog Scale, Activities Assessment Scale, Hernia-Related Quality-of-Life Survey, and Short-Form 36 Health Survey (SF-36) quality-of-life scores from repair. The secondary outcome was the overall cost per patient. ResultsAmong the 165 patients included in the study, 82 were randomized to biologic meshes and 83 to synthetic meshes. There were no significant differences in the performance between the 2 mesh types with regard to quality-of-life measures using a mixed model approach. This result was consistent even when performing subgroup analysis based on wound contamination. However, nonparametric tests comparing the differences in quality-of-life measures from preoperative to 24-month postoperative timepoints revealed that the synthetic mesh group showed a greater reduction in disability than biologic mesh for the SF-36 (median [interquartile range] of 20 [5–30] vs 6 [1–20], P = .025). This difference was due to reductions in the physical role limitations (62 [0–100] vs 0 [0–50], P = .018) and the pain (38 [12–50] vs 12 [0–25], P = .012) domains of the SF-36. Overall cost per patient was greater for biologic meshes (mean [95% confidence interval] of $80,420 [$66,485–$94,355] vs $61,036 [$48,946–$73,125], P = .038), regardless of insurance type. ConclusionIn this randomized clinical trial, there were no differences in changes in quality-of-life scores at the 2-year timepoint except for the SF-36, where the synthetic mesh may be associated with less pain and physical role limitations than the biologic mesh. Overall costs per patient were less for synthetic than biologic mesh.

The effects of introducing virtual reality communication simulation in students' learning in a fundamentals of nursing practicum: A pragmatic randomized control trials

AimThis study was conducted to examine the effectiveness of a virtual reality communication simulation (VRCS) in teaching communication skills in fundamentals of nursing practicum. BackgroundEffective communication skills are an integral part of the nursing profession and the foundation of high-quality nursing care. Effective communication not only addresses the needs of patients but is also necessary for maintaining patient safety. Many studies have reported the inadequacy of nursing students in communicating with patients. Nursing students often experience stress due to their lack of adequate skills to communicate effectively with patients and their family members. DesignA pragmatic randomized controlled trial research with four within-subjects assessments (at the baseline (T0), 1st week (T1) and 3rd week (T2) of the clinical practice and 1 week after the end of the clinical practice (T3)) and between-subjects assessments. Settings and participantsEighty-four nursing students at a university of Science and Technology in central Taiwan. MethodsThe students were randomly assigned to an experimental group (n = 42) and a control group (n = 42). The experimental group received a VRCS, whereas the control group received the nurse–patient communication teaching video. The data were collected from April 2022 to August 2022. The Kalamazoo Essential Element Communication Checklist, Communication Self-Assessment Scale, Learning Satisfaction Questionnaire and Stress Scale for Nursing Students in Clinical Practice were used for data collection. ResultsAt baseline, the control group had higher scores on communication ability and confidence compared with the experimental group (t = −3.91, p <.001; and t = −2.35, p =.021). In the first week of clinical practice, the experimental group had significantly higher mean scores for communication ability compared with the control group (β = 15.99, 95 % confidence interval [CI] 13.79, 18.18) and communication confidence and learning satisfaction compared with controls at T1, T2 and T3 of the clinical practice (all, p <.001). The clinical practice stress scores of the experimental group were significantly lower than those of the control group at T1, T2 and T3 of the clinical practice (all, p <.05). ConclusionsThe newly developed VRCS is acceptable and worthwhile for training nursing students to develop communication abilities. This study suggests that VRCS practice should be arranged as early as possible in fundamentals of nursing practice courses and before the fundamentals of nursing practicum so as to facilitate the learning of effective communication. Follow-up research is needed to evaluate the long-term effects of virtual reality education in nursing practice.

Home- versus clinic-based exercise intervention in patients with heart failure (EXIT-HF trial): a pragmatic randomized controlled trial

Abstract Background The limited accessibility partially explains the low uptake of cardiac rehabilitation (ExCR) for heart failure (HF). Home-based programs might address those obstacles but few data from randomized trials are available. Purpose To compare the effectiveness of a home-based versus clinic-based ExCR intervention in HF patients. Methods Single-center, single-blind, parallel groups, non-inferiority pragmatic randomized control trial (1:1 and after COVID-19 2:1 home- vs clinic-based). Adult HF patients referred to our cardiac rehabilitation (CR) unit were randomized to either a clinic-based (24 supervised sessions at a CR unit of a tertiary hospital over 12 weeks) or home-based (4 supervised ExT sessions to familiarize with the training protocol and the remaining sessions continued at home) over 12 weeks. Exercise training protocol consisted of a combination of endurance (at 60%-80% of peak oxygen uptake [VO2peak] and resistance training (elastic bands). The primary endpoint was the change in VO2peak at the end of the 12-week program. Secondary outcomes included adherence (&amp;gt;80% of sessions attendance) and change of Minnesota Living with HF Questionnaire (MLHFQ) scores. Results 120 patients (mean age 64±11 years; 64% men) were randomized: 44 to clinic- and to 76 home-based intervention. 41% had an ischemic cardiomyopathy, 27% had an ICD/CRT, the mean LVEF was 36±11% (62% had LVEF &amp;lt;40%), 73% were on NYHA class II, and the median NT-proBNP was 361 [IQR 170-1008] ng/mL. Intervention groups were well balanced, including basal VO2peak that was similar between groups (17.8±4.8 vs 18.1±5.2 mL/min/Kg; p=0.75). Adherence was similar between groups (87.5% vs 82.5%; p=0.50). At week 12, on average, patients increased VO2 peak by 0.9±2.5 mL/min/Kg compared to baseline (p&amp;lt;0.001). No significant differences were found between clinic- and home-based interventions (p=0.25). Consistently, the MLHFQ total score decreased significantly overall (-10.3±1.7 points; p&amp;lt;0.001), with no significant differences between groups (p=0.91). The drop-out rate was 14% and 17% in clinic- and home-based groups, respectively. Conclusions The clinical impact of home-based CR program on peakVO2 and health-related quality of life of HF patients was similar to a standard supervised clinic-based one. Our data support the home-based program as an effective alternative way of delivering CR in HF.

A feasibility and pilot additive randomised control trial of attachment security priming during behavioural activation.

There is some initial evidence that attachment security priming may be useful for promoting engagement in therapy and improving clinical outcomes. This study sought to assess whether outcomes for behavioural activation delivered in routine care could be enhanced via the addition of attachment security priming. This was a pragmatic two-arm feasibility and pilot additive randomised control trial. Participants were recruited with depression deemed suitable for a behavioural activation intervention at Step 2 of a Talking Therapies for Anxiety and Depression service. Ten psychological wellbeing practitioners were trained in implementing attachment security priming. Study participants were randomised to either behavioural activation (BA) or BA plus an attachment prime. The diagrammatic prime was integrated into the depression workbook. Feasibility outcomes were training satisfaction, recruitment, willingness to participate and study attrition rates. Pilot outcomes were comparisons of clinical outcomes, attendance, drop-out and stepping-up rates. All practitioners recruited to the study, and training satisfaction was high. Of the 39 patients that were assessed for eligibility, 24 were randomised (61.53%) and there were no study drop-outs. No significant differences were found between the arms with regards to drop-out, attendance, stepping-up or clinical outcomes. Further controlled research regarding the utility of attachment security priming is warranted in larger studies that utilise manipulation checks and monitor intervention adherence.

The stroke transitional care intervention for older adults with stroke and multimorbidity: a multisite pragmatic randomized controlled trial

BackgroundThis study aimed to test, in real-world clinical practice, the effectiveness of a Transitional Care Stroke Intervention (TCSI) compared to usual care on health outcomes, self-management, patient experience, and health and social service use costs in older adults (≥ 55 years) with stroke and multimorbidity (≥ 2 chronic conditions).MethodsThis pragmatic randomized controlled trial (RCT) included older adults discharged from hospital to community with stroke and multimorbidity using outpatient stroke rehabilitation services in two communities in Ontario, Canada. Participants were randomized 1:1 to usual care (control group) or usual care plus the 6-month TCSI (intervention group). The TCSI was delivered virtually by an interprofessional (IP) team, and included care coordination/system navigation support, phone/video visits, monthly IP team conferences, and an online resource to support system navigation. The primary outcome was risk of hospital readmission (all cause) after six-months. Secondary outcomes included physical and mental functioning, stroke self-management, patient experience, and health and social service use costs. The intention-to-treat principle was used to conduct the primary and secondary analyses.ResultsNinety participants were enrolled (44 intervention, 46 control); 11 (12%) participants were lost to follow-up, leaving 79 (39 intervention, 40 control). No significant between-group differences were seen for baseline to six-month risk of hospital readmission. Differences favouring the intervention group were seen in the following secondary outcomes: physical functioning (SF-12 PCS mean difference: 5.10; 95% CI: 1.58–8.62, p = 0.005), stroke self-management (Southampton Stroke Self-Management Questionnaire mean difference: 6.00; 95% CI: 0.51—11.50, p = 0.03), and patient experience (Person-Centred Coordinated Care Experiences Questionnaire mean difference: 2.64, 95% CI: 0.81, 4.47, p = 0.005). No between-group differences were found in total healthcare costs or other secondary outcomes.ConclusionsAlthough participation in the TCSI did not impact hospital readmissions, there were improvements in physical functioning, stroke self-management and patient experience in older adults with stroke and multimorbidity without increasing total healthcare costs. Challenges associated with the COVID-19 pandemic, including the shift from in-person to virtual delivery, and re-deployment of interventionists could have influenced the results. A larger pragmatic RCT is needed to determine intervention effectiveness in diverse geographic settings and ethno-cultural populations and examine intervention scalability.Trial registrationClinicalTrials.gov Identifier: NCT04278794. Registered May 2, 2020.

Home- versus centre-based EXercise InTervention in patients with Heart Failure (EXIT-HF trial): A pragmatic randomized controlled trial

IntroductionThe limited accessibility and the lack of adherence explain, in part, the low proportion of heart failure (HF) patients undergoing exercise-based cardiac rehabilitation (CR) programs. Home-based programs showed to be as effective and less costly than centre-based ones and might address those obstacles. Whether the evidence from international studies can be applied to our population is still unclear. ObjectivesTo compare the clinical and economic impact of a home-based versus centre-based CR intervention in HF patients. MethodsThis is a single-center, single-blind, parallel groups, non-inferiority pragmatic randomized control trial. Adult HF patients (n=120) will be randomized to either a centre-based or home-based CR program. In both groups’ patients will participate in a 12-week combined CR program with 2 sessions per week. Exercise training (ExT) protocol consists of a combination of endurance [(at 60%–80% of peak oxygen uptake (VO2peak)] and resistance training (elastic bands). Those allocated to the home-based program will start with 4–5 supervised ExT sessions to familiarize themselves with the training protocol and then will continue the remaining sessions at home. The primary endpoint is the change in VO2peak at the end of the 12-week program. Secondary outcomes include alterations in circulating biomarkers, physical fitness, physical activity, quality of life, diet, psychological wellbeing, dyspnea, and cost-effectiveness analyses. ResultsPatients are currently being recruited for the study. The study started in November 2019 and data collection is anticipated to be completed by December 2022. This is the first study in Portugal comparing the traditional CR program with a home-based program in HF patients. Our study results will better inform healthcare professionals who care for HF patients regarding CR.

A rehabilitation intervention to improve recovery after an episode of delirium in adults over 65 years (RecoverED): study protocol for a multi-centre, single-arm feasibility study

BackgroundDelirium affects over 20% of all hospitalised older adults. Delirium is associated with a number of adverse outcomes following hospital admission including cognitive decline, anxiety and depression, increased mortality and care needs. Previous research has addressed prevention of delirium in hospitals and care homes, and there are guidelines on short-term treatment of delirium during admission. However, no studies have addressed the problem of longer-term recovery after delirium and it is currently unknown whether interventions to improve recovery after delirium are effective and cost-effective. The primary objective of this feasibility study is to test a new, theory-informed rehabilitation intervention (RecoverED) in older adults delivered following a hospital admission complicated by delirium to determine whether (a) the intervention is acceptable to individuals with delirium and (b) a definitive trial and parallel economic evaluation of the intervention are feasible.MethodsThe study is a multi-centre, single-arm feasibility study of a rehabilitation intervention with an embedded process evaluation. Sixty participants with delirium (aged > 65 years old) and carer pairs will be recruited from six NHS acute hospitals across the UK. All pairs will be offered the intervention, with follow-up assessments conducted at 3 months and 6 months post-discharge home. The intervention will be delivered in participants’ own homes by therapists and rehabilitation support workers for up to 10 intervention sessions over 12 weeks. The intervention will be tailored to individual needs, and the chosen intervention plan and goals will be discussed and agreed with participants and carers. Quantitative data on reach, retention, fidelity and dose will be collected and summarised using descriptive statistics. The feasibility outcomes that will be used to determine whether the study meets the criteria for progression to a definitive randomised controlled trial (RCT) include recruitment, delivery of the intervention, retention, data collection and acceptability of outcome measures. Acceptability of the intervention will be assessed using in-depth, semi-structured qualitative interviews with participants and healthcare professionals.DiscussionFindings will inform the design of a pragmatic multi-centre RCT of the effectiveness and cost-effectiveness of the RecoverED intervention for helping the longer-term recovery of people with delirium compared to usual care.Trial registrationThe feasibility study was registered: ISRCTN15676570

“I thought it was for guys that did needles”: Medication perceptions and lay expertise among medical research participants

IntroductionAlthough randomized controlled trials (RCTs) examine “objective” indicators of safety and efficacy of investigational drugs, participants may not perceive study medications as neutral entities. Some medications are imbued with social and cultural meaning, such as stigmatized medications for opioid use disorders. Such perceptions surrounding substance use treatments can extend to the research context and shape RCT participants' experiences with and adherence to study medications. MethodsConsidering these complexities in substance use research, we conducted a nested qualitative study within a multi-site, pragmatic RCT in Canada testing two treatments (methadone versus buprenorphine/naloxone) for opioid use disorder. Between 2017 and 2020, we conducted 115 interviews with 75 RCT participants across five trial sites in British Columbia, Alberta, Ontario, and Quebec. ResultsUsing an abductive coding approach, we characterized participants by their previous experience with medication for opioid use disorder and by their exposure to drug culture and drug scenes. Across these experience types, we identified systematic differences around participants' perceptions of the study medications, sources of information and expertise, and medication stigma. ConclusionOur findings illustrate the critical importance of social context in shaping medication beliefs and study experiences among people who use drugs, with implications for the conduct of future RCTs in substance use.

Feasibility of comparing medical management and surgery (with neurosurgery or stereotactic radiosurgery) with medical management alone in people with symptomatic brain cavernoma – protocol for the Cavernomas: A Randomised Effectiveness (CARE) pilot trial

IntroductionThe top research priority for cavernoma, identified by a James Lind Alliance Priority setting partnership was ‘Does treatment (with neurosurgery or stereotactic radiosurgery) or no treatment improve outcome for people...

Telemedicine for follow-up of systemic lupus erythematosus during the 2019 coronavirus pandemic: A pragmatic randomized controlled trial.

Patients with systemic lupus erythematous were vulnerable to severe coronavirus disease 2019 infection and the negative impact of disrupted healthcare delivery. Telemedicine has been a popular alternative to standard in-person care during the pandemic despite the lack of evidence. This was a 1-year pragmatic randomized-controlled trial. Patients followed at the lupus nephritis clinic were randomized to either telemedicine or standard follow-up in a 1:1 ratio. Patients in the telemedicine group were followed up via videoconferencing. Standard follow-up group patients continued conventional in-person outpatient care. The primary outcome of the study was the proportion of patients in low disease activity after 1 year. Secondary outcomes included cost-of-illness, safety, and various patient-reported outcomes. From 6/2020 to 12/2021, 144 patients were randomized and 141 patients (telemedicine: 70, standard follow-up: 71) completed the study. At 1 year, 80.0% and 80.2% of the patients in the telemedicine group and standard follow-up group were in lupus low disease activity state or complete remission, respectively (p = 0.967). Systemic lupus erythematous disease activity indices, number of flares and frequency of follow-ups were also similar. There were no differences in the cost-of-illness, quality of life or mental health scores. However, significantly more patients in the telemedicine group (41.4% vs 5.6%; p < 0.001) required switch of mode of follow-up and higher proportion of them had hospitalization during the study period (32.9% vs 15.5%; p = 0.016). Being in the telemedicine group or not in low disease activity at baseline were the independent predictors of hospitalization (odds ratio: 2.6; 95% confidence interval: 1.1-6.1, odds ratio: 2.7, 95% confidence interval: 1.1-6.7, respectively) in the post hoc analysis. In patients with systemic lupus erythematous, telemedicine predominant follow-up resulted in similar 1-year disease control compared to standard care. However, it needed to be complemented by in-person visits, especially in patients with unstable disease.

Can mindfulness-based interventions improve outcomes in cognitive-behavioural therapy for chronic insomnia disorder in the general population? Systematic review and meta-analysis.

Cognitive-behavioural therapy for insomnia (CBT-I) is the recommended first-line therapy for adults with chronic insomnia disorder (ID), which is characterized by hyperarousal. Mindfulness-based interventions (MBIs) are protocols aimed at stress reduction based on non-judgmental attention control in the present moment. However, MBIs have been increasingly used without a clear scientific basis. The objective of this analysis was to examine if MBIs could be useful as a component of the CBT-I therapeutic system through a systematic review and meta-analysis of randomized controlled trials (RCTs) and non-randomized studies (NRS) searched in PubMed, PsycINFO, Cochrane and WoS. The Insomnia Severity Index (ISI) was the primary outcome, while the Pittsburgh Sleep Quality Index (PSQI) and a composite sleep variable (CSV) were secondary outcomes. Thirteen articles corresponding to nine studies (three pragmatic RCTs, three explanatory RCTs and three NRS) were included. The omnibus test found that MBIs had a small to medium effect size on ISI nearing signification when comparing active control groups in the pretest-posttest period [Δ = 0.44, p= 0.07], a medium, non-significant, effect size on PSQI [Δ = 0.52, p= 0.18], and a significant though small effect size on CSV [Δ = 0.05, p< 0.01]. No heterogeneity was found. The analysis could not demonstrate that MBIs, combined with CBT-I components in some studies, positively affected ID in the general adult population. This was probably due to the lack of pragmatic designs and suitable measuring instruments. Recommendations are made for designing further studies to address these issues.

Tracking adaptation strategies of an HIV prevention intervention among youth in Nigeria: a theoretically informed case study analysis of the 4 Youth by Youth Project

BackgroundAlthough many behavioral interventions are adapted, little is known about the reasons for adaptations and the process and outcomes influencing adaptations. To address this gap, we explored the adaptations made to promote HIV prevention services, including HIV self-testing (HIVST), among Nigerian youth.MethodsThe main objective of this qualitative case study design was to document the adaptations made over time using the Framework for Reporting Adaptations and Modifications – Expanded (FRAME). Between 2018 and 2020, we organized four participatory activities as part of the 4 Youth by Youth project to increase the uptake of HIVST services in Nigeria—an open call, a designathon, a capacity-building bootcamp and a pilot feasibility trial. We also began the process of implementing a final intervention using a pragmatic randomized control trial (RCT). The open call solicited creative strategies to promote HIVST among Nigerian youth and then had experts evaluate them. The designathon brought together youth teams to further develop their HIVST service strategies into implementation protocols. Teams determined to be exceptional were invited to a four-week capacity-building bootcamp. The five teams that emerged from the bootcamp were supported to pilot their HIVST service strategies over a 6-month period. The adapted intervention is currently being evaluated in a pragmatic RCT. We transcribed meeting reports and conducted document reviews of study protocols and training manuals.ResultsSixteen adaptations were identified and categorized into three domains: (1) modifications to the content of the intervention (i.e. photo verification system and/or Unstructured Supplementary Service Data (USSD) system to verify HIVST); (2) modifications to the delivery the intervention (i.e. implement participatory learning community sessions to provide supportive supervision and technical support); (3) modifications to the evaluation processes (i.e. economic evaluation to estimate the cost of implementing intervention on a larger scale). Frequent reasons for adaptation included increasing intervention reach, modifying interventions to enhance their appropriateness and fit with the recipient, and increasing the intervention’s feasibility and acceptability. Most adaptations were planned and reactive, and the need for modifications was determined by the youths, 4YBY program staff, and advisory group.ConclusionsFindings suggest that the nature of adaptations made throughout the implementation process reflects the necessity of evaluating services in context while adjusting to specific challenges as they are identified. Further research is needed to understand the effect of these adaptations on the overall intervention effect as well as the quality of youth engagement.

D150. Effectiveness of Traumatic Wounds Treatment with Negative-pressure Wound Therapy with Instillation: Pragmatic Randomized Control Trial

PURPOSE: Negative Pressure Wound Therapy (NPWT) has been associated with instillation (NPWTi) to provide cleaning cycles combined with vacuum therapy, avoiding constant dressings changes. NPWTi meets the treatment demands of wounds at risk infection. The aim of this study is to compare clinical results and direct costs of soft tissue traumatic wounds treatment submitted to three different coverings. METHODS: Prospective, pragmatic randomized controlled trial evaluating adult patients with traumatic wounds. 120 patients with 131 wounds were randomized to standard of care, mainly with layers of gauze (n=41), conventional NPWT (n=46), and NPWTi (n=44). Negative pressure was set at -125 mmHg in continuous mode, applied for two hours in the NPWTi group, followed by normal saline instillation with 20 minutes of dwell time. RESULTS: Sample consisted of 120 patients from 139 screened for eligibility. The mean age was 37.3 (SD14.9; min16;max86) years, primarily male (78%) with low Charlson Index (0.36;SD 1.0). Wounds were mainly degloving injuries (57%) with a mean size of 192 cm2 (min13; max1303), affecting predominantly lower extremities (85%), caused by vehicle accidents. There were no statistical differences between groups regarding baseline data. Wound time of closure (in days) was lower in the instillation group (9.2NPWTi; 11.5NPWT;14.6Layering; p=0.005), as well as the number of surgical procedures (2.9NPWTi; 3.5NPWT;6.9 Layering; p<0.001). Length of stay (in days) was slightly lower in the NPWT group (25.1NPWT;27.8NPWTi;29.1Layering; p=0.226). Costs (in $USD) were higher in the Gauze group ($5510NPWTi; $5,643NPWT;$7,162Gauze;p=0.873). CONCLUSION: Negative pressure with or without installation therapy was more effective and less costly than gauze therapy in treating complex traumatic wounds.

Differential effect of cannabis use on opioid agonist treatment outcomes: Exploratory analyses from the OPTIMA study

IntroductionConflictual evidence exists regarding the effects of cannabis use on the outcomes of opioid agonist therapy (OAT). In this exploratory analysis, we examined the effect of recent cannabis use on opioid use, craving, and withdrawal symptoms, in individuals participating in a trial comparing flexible buprenorphine/naloxone (BUP/NX) take-home dosing model to witnessed ingestion of methadone. MethodsWe analyzed data from a multi-centric, pragmatic, 24-week, open label, randomized controlled trial in individuals with prescription-type opioid use disorder (n = 272), randomly assigned to BUP/NX (n = 138) or methadone (n = 134). The study measured last week cannabis and opioid use via timeline-follow back, recorded at baseline and every two weeks during the study. Craving symptoms were measured using the Brief Substance Craving Scale at baseline, and weeks 2, 6, 10, 14, 18 and 22. The study measured opioid withdrawal symptoms via Clinical Opiate Withdrawal Scale at treatment initiation and weeks 2, 4, and 6. ResultsThe mean maximum dose taken during the study was 17.3 mg/day (range = 0.5–32 mg/day) for BUP/NX group and 67.7 mg/day (range = 10–170 mg/day) in the methadone group. Repeated measures generalized linear mixed models demonstrated that cannabis use in the last week (mean of 2.3 days) was not significantly associated with last week opioid use (aβ ± standard error (SE) = −0.06 ± 0.04; p = 0.15), craving (aβ ± SE = −0.05 ± 0.08, p = 0.49), or withdrawal symptoms (aβ ± SE = 0.09 ± 0.1, p = 0.36). Bayes factor (BF) for each of the tested models supported the null hypothesis (BF < 0.3). ConclusionsThe current study did not demonstrate a statistically significant effect of cannabis use on outcomes of interest in the context of a pragmatic randomized-controlled trial. These findings replicated previous results reporting no effect of cannabis use on opioid-related outcomes.

A Study Protocol for a Multicenter, Pragmatic, Randomized Controlled, Parallel-Grouped Pilot Clinical Trial: Effectiveness of Non-Pharmacological Versus Pharmacological Treatments for Non-Acute Lumbar Disc Herniation

Background: This study was the development of a protocol for the comparison between the efficacy of non-pharmacological and pharmacological treatment approaches for lumbar disc herniation in a pragmatic environment to obtain real-world based study data.Methods: The protocol sets out a two-armed, parallel, multicenter pragmatic, randomized-controlled trial (RCT) which will be conducted in four spine specialist hospitals in Korea to determine cost-efficiency.Results: The study will enroll 36 participants and allocate patients into either the non-pharmacological treatment group or the pharmacological treatment group in a 1:2 ratio. Patients must have evidence of disc-related disease diagnosed using MRI, as well as having lower back pain or radiating leg pain (numeric rating scale score ≥ 5). The treatment will last for 8 weeks with a 26-week follow-up. The primary outcome will be measured using the Oswestry Disability Index score from Week 9. Secondary outcomes related to lower back pain and radiating leg pain will be measured using the scores from the numeric rating scale, the visual analogue scale, the European Quality of Life 5 Dimensions 5 Level Version), the 12-item Short Form Survey, and the patient global impression of change.Conclusion: This is the first protocol for a pragmatic RCT evaluating the efficacy, safety, and cost-efficiency of non-pharmacological and pharmacological treatment strategies in a clinical setting. Following the basis of this protocol, RCTs may play an important role in establishing guidelines for treating radiating leg pain and lower back pain and provide effective information to clinicians in practical settings.

Internet-delivered cognitive behavioural therapy for insomnia disorder in depressed patients treated at an outpatient clinic for mood disorders: protocol of a randomised controlled trial

BackgroundMajor depression is a highly prevalent disorder causing severe personal distress, and high societal costs. Patients with depression often have comorbid insomnia disorder (ID) leading to even worse personal distress and worse treatment outcomes. Recent results from a non-randomised pilot study with internet-delivered Cognitive Behavioural Therapy (CBTi) for Insomnia (I-Sleep) added to regular depression care were promising regarding feasibility and initial effects on insomnia complaints and depression. However, no randomised controlled trial (RCT) has been performed yet to access the (cost-) effectiveness of I-Sleep for depression. Therefore, this protocol article presents the design of an RCT aimed to assess the (cost-) effectiveness of I-Sleep in addition to usual care for depression compared to usual care alone in depressed patients with a comorbid Insomnia Disorder (ID) treated at outpatient clinics for mood disorders. Methods /designThis is a multi-centre RCT with measurements at baseline and at 3, 6, 9, and 12 months of follow-up. Patients with depression and an ID are randomised to either I-Sleep treatment followed by regular depression care or to regular depression care alone. Our aim is to recruit one hundred and seventy-five patients from multiple outpatient clinics for mood disorders. The primary outcome is the change in depressive symptoms over 12 months of follow-up measured with the Patient Health Questionnaire (PHQ-9). Secondary outcomes are recovery from depression (PHQ-9), insomnia severity (Insomnia Severity Index, ISI), daily functioning (Work and Social Adjustment Scale, WSAS), general quality of life (EuroQol 5-level version, EQ-5D-5L), and societal costs (Adapted versions of the iMTA Productivity Cost Questionnaire, iPCQ and iMTA Medical Cost Questionnaire, iMCQ).DiscussionWe hypothesize that the addition of I-Sleep to usual care will result in a significant improvement in depression treatment outcomes and quality of life as well as a decrease in healthcare and societal costs compared to usual care alone. This study is the first pragmatic RCT evaluating the effectiveness and cost-effectiveness of adding CBTi to usual care for depression.Trial registrationNetherlands Trial Register (NL8955). Registered on October 6th2020. https://trialsearch.who.int/Trial2.aspx?TrialID=NL8955

Protein restriction for diabetic kidney disease.

Diabetic kidney disease (DKD) continues to be the leading cause of kidney failure across the world. For decades dietary protein restriction has been proposed for patients with DKD with the aim to retard the progression of chronic kidney disease (CKD) towards kidney failure. However, the relative benefits and harms of dietary protein restriction for slowing the progression of DKD have not been addressed. To determine the efficacy and safety of low protein diets (LPD) (0.6 to 0.8 g/kg/day) in preventing the progression of CKD towards kidney failure and in reducing the incidence of kidney failure and death (any cause) in adult patients with DKD. Moreover, the effect of LPD on adverse events (e.g. malnutrition, hyperglycaemic events, or health-related quality of life (HRQoL)) and compliance were also evaluated. We searched the Cochrane Kidney and Transplant Register of Studies up to 17 November 2022 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. We included randomised controlled trials (RCTs) or quasi-RCTs in which adults with DKD not on dialysis were randomised to receive either a LPD (0.6 to 0.8 g/kg/day) or a usual or unrestricted protein diet (UPD) (≥ 1.0 g/kg/day) for at least 12 months. Two authors independently selected studies and extracted data. Summary estimates of effect were obtained using a random-effects model. Results were summarised as risk ratios (RR) with 95% confidence intervals (CI) for dichotomous outcomes and mean difference (MD) or standardised MD (SMD) with 95% CI for continuous outcomes. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. We identified eight studies involving 486 participants with DKD. The prescribed protein intake in the intervention groups ranged from 0.6 to 0.8 g/kg/day. The prescribed protein intake in the control groups was ≥ 1.0 g/kg/day, or a calculated protein intake ≥ 1.0 g/kg/day if data on prescribed protein intake were not provided. The mean duration of the interventions was two years (ranging from one to five years). Risks of bias in most of the included studies were high or unclear, most notably for allocation concealment, performance and detection bias. All studies were considered to be at high risk for performance bias due to the nature of the interventions. Most studies were not designed to examine death or kidney failure. In low certainty evidence, a LPD may have little or no effect on death (5 studies, 358 participants: RR 0.38, 95% CI 0.10 to 1.44; I² = 0%), and the number of participants who reached kidney failure (4 studies, 287 participants: RR 1.16, 95% CI 0.38 to 3.59; I² = 0%). Compared to a usual or unrestricted protein intake, it remains uncertain whether a LPD slows the decline of glomerular filtration rate over time (7 studies, 367 participants: MD -0.73 mL/min/1.73 m²/year, 95% CI -2.3 to 0.83; I² = 53%; very low certainty evidence). It is also uncertain whether the restriction of dietary protein intake impacts on the annual decline in creatinine clearance (3 studies, 203 participants: MD -2.39 mL/min/year, 95% CI -5.87 to 1.08; I² = 53%). There was only one study reporting 24-hour urinary protein excretion. In very low certainty evidence, a LPD had uncertain effects on the annual change in proteinuria (1 study, 80 participants: MD 0.90 g/24 hours, 95% CI 0.49 to 1.31). There was no evidence of malnutrition in seven studies, while one study noted this condition in the LPD group. Participant compliance with a LPD was unsatisfactory in nearly half of the studies. One study reported LPD had no effect on HRQoL. No studies reported hyperglycaemic events. Dietary protein restriction has uncertain effects on changes in kidney function over time. However, it may make little difference to the risk of death and kidney failure. Questions remain about protein intake levels and compliance with protein-restricted diets. There are limited data on HRQoL and adverse effects such as nutritional measures and hyperglycaemic events. Large-scale pragmatic RCTs with sufficient follow-up are required for different stages of CKD.

Behavioral Skills Training for Teaching Safety Skills to Mental Health Clinicians: Protocol for a Pragmatic Randomized Control Trial

Workplace violence is an increasingly significant topic, particularly for staff working in mental health settings. The Centre for Addiction and Mental Health (CAMH), Canada's largest mental health hospital, considers workplace safety a high priority and consequently has mandated staff safety training. For clinical staff, key components of this training are self-protection and team-control skills, which are a last resort when an individual is at an imminent risk of harm to self or others and other interventions are ineffective (eg, verbal de-escalation). For the past 20 years, CAMH's training-as-usual (TAU) has been based on a 3D approach (description, demonstration, and doing), but without any competency-based assessment. Recent staff reports indicate that the acquisition and retention of these skills may be problematic and that staff are not always confident in their ability to effectively address workplace violence. The current literature lacks studies that evaluate how staff are trained to acquire these physical skills and consequently provides no recommendations or best practice guidelines. To address these gaps described by the staff and in the literature, we have used an evidence-based approach from the field of applied behavior analysis known as behavioral skills training (BST), which requires trainees to actively execute targeted skills through instruction, modeling, practice, and feedback loop. As part of this method, competency checklists of skills are used with direct observation to determine successful mastery. Our objectives are to evaluate the effectiveness of BST versus TAU in terms of staff confidence; their competence in self-protection and team-control physical skills; their level of mastery (predefined as 80% competence) in these skills; and their confidence, competency, and mastery at 1 month posttraining. We are using a pragmatic randomized controlled trial design. New staff registering for their mandatory safety training are randomly assigned to sessions which are, in turn, randomly assigned to either the BST or TAU conditions. Attendees are informed and consented into the study at the beginning of training. Differences between those consenting and those not consenting in terms of role and department are tracked to flag potential biases. This study was internally funded and commenced in January 2021 after receiving ethics approval. As of May 2022, data collection is complete; half of the baseline, posttraining, and 1-month videotapes have been rated, and three-fourths of the interrater reliability checks have been completed. The analysis is expected to begin in late summer 2022 with results submitted for publication by fall 2022. The findings from this study are expected to contribute to both the medical education literature as well as to the field of applied behavioral analysis where randomized controlled trial designs are rare. More practically, the results are also expected to inform the continuing development of our institutional staff safety training program. DERR1-10.2196/39672.

Impact of a web‐based psychoeducational intervention on carer mental health quality of life: Results from a pragmatic randomized control trial

AbstractBackgroundCarers of a person who is living with dementia in long‐term care experience transitions which can challenge their mental health. My Tools for Care‐In Care (MT4C‐In Care) is an online psychoeducational intervention that aims to offer informational, appraisal, and emotional support to assist carers to adapt to the transitions they experience. This presentation will report on the impact of using MT4C‐In Care on carer outcomes including mental health quality of life (primary outcome), and secondary outcomes of social support, hope, self‐efficacy, grief and loneliness.MethodIn a single blinded pragmatic randomized control trial, 234 Canadians participated from Alberta, Saskatchewan, Manitoba, and Ontario between February 2020 and October 2021. Carers were eligible if they were ≥18 years of age, had an email address and internet access, and provided physical, emotional or financial care to an adult ≥65 years of age who was living with dementia in a long‐term care home. The intervention group received access to MT4C‐In Care for 2 months; the educational control group received an Alzheimer Society information booklet. Outcomes were assessed using valid and reliable scales at baseline, 2 months and 4 months in telephone interviews. Generalized estimating equations were used to compare changes in the outcomes over time in the treatment and control groups, adjusting for clinically important covariates of gender, age, heart disease, caregiver relationship (spouse vs. non‐spouse) and outcome variables measured at baseline.ResultThe primary outcome, mental health quality of life (p = 0.035), improved in both groups over time, along with hope (p = 0.041) and grief (physical distress, p = 0.068). Comparing change in the intervention to the control group, treatment benefit was observed for secondary outcomes of grief (existential concerns; p = 0.095) and social support (total score p = 0.049 and family subscale p = 0.065), but not for the primary outcome of mental health quality of life (p = 0.93).ConclusionMT4C‐In Care demonstrates benefits for carers in terms of both the primary outcome (mental health quality of life), and secondary outcomes. In comparison to an active educational control group, MT4C‐In Care lessens grief and promotes social support, helping to explain how this intervention promotes carers’ mental health.

Effectiveness of intensive perioperative nutrition therapy among adults undergoing gastrointestinal and oncological surgery in a public hospital: study protocol for a pragmatic randomized control trial

BackgroundPerioperative malnutrition is common in patients undergoing gastrointestinal-oncology surgery and is associated with longer hospital stays, increased postoperative complications, poorer quality of life, and lower survival rates. Current practice emphasizes the role of early perioperative nutrition therapy as an early intervention to combat the postoperative complications of patients and the implementation is now widely adopted. However, there is still a lack of research on determining the effectiveness of intensive nutrition therapy and providing ONS perioperative locally. This becomes the significance of this study and serves as a basis for management and guideline in the local hospital settings.MethodsThis is a pragmatic randomized control trial study where elective admitted patients will be randomly divided into the intervention (SS) or control (NN) group. All data will be collected during a face-to-face interview, anthropometric measurement, blood sampling (albumin, white blood count, hemoglobin, and c-reactive protein), handgrip strength, and postoperative complications. Group SS will be receiving a tailored lifestyle and intensively supplemented with oral nutrition support as compared to Group NN that will receive standard medical care. The primary outcome for this study is the length of stay in the hospital. Additional outcome measures are changes in biochemical profile and nutritional and functional status. The effects of intervention between groups on the outcome parameters will be analyzed by using the SPSS General Linear Model (GLM) for the repeated measure procedure.DiscussionThe intervention implemented in this study will serve as baseline data in providing appropriate nutritional management in patients undergoing gastrointestinal and oncological surgery.Trial registrationClinicalTrials.gov Protocol Registration and Results System (PRS) NCT04347772. Registered on 20 November 2019.