Two-arm Parallel Group Design Research Articles

Effects of an ice roller on chronic kidney disease-associated pruritus in patients receiving haemodialysis.

Chronic kidney disease-associated pruritus is a distressing symptom and has a far-reaching impact on patients' sleep and quality of life for most patients receiving haemodialysis. Traditional therapies have limited effectiveness. This study aimed to invent a self-operated ice roller and evaluate its efficacy in relieving pruritus, sleep quality, and quality of life. This study was experimental with a two-arm parallel group design. A convenient sampling method was used to recruit 60 patients receiving haemodialysis who reported pruritus (5D-Itch Scale score >5) lasting over 4 weeks in Taiwan. The participants were randomly assigned to one of two groups: the intervention group used an ice roller for 7 days, while the control group received no anti-pruritus treatment. This study was experimental with a two-arm parallel group design. The measurement instruments included the 5D-Itch Scale, Pittsburgh Sleep Quality Index and WHOQOL-BREF-Taiwan Version. The analysis of covariance, chi-square, Independent t tests,and partial Eta2 (η2 p) were used to analyse the data. The participants' mean age was 62.77 years. Application of the ice roller significantly decreased overall pruritus (p < .05; η2 p = .09) and distribution of pruritus-associated bodily parts (p = .03; η2 p = .08). There were no statistically significant differences in sleep quality and related indicators between the experimental and control groups at the study endpoint. Regarding quality of life, only the social relationship domain significantly differed between the two groups (p = .02; η2 p = .08). The ice roller can decrease pruritus and its distribution in patients receiving haemodialysis, serving as an adjunct therapy alongside conventional anti-pruritus treatments.

Effectiveness of a Culturally Responsive mHealth Gaming Application to Improve Diabetes Health Literacy in India: A Randomized Controlled Trial.

The purpose of this study was to determine the effectiveness of a culturally responsive interactive gaming mHealth educational application designed to improve diabetes health literacy among an underserved urban population in India when compared with a traditional approach of verbal education. In addition, relationships between participant sociodemographic variables and participant knowledge were assessed. A randomized controlled trial was conducted using a two-arm parallel, single-blinded intervention and control group design. The parallel groups were the mHealth Education group serving as the intervention group and the Verbal Education group serving as the control group. The mHealth application was as effective in improving diabetes health literacy as verbal education. Results for the difference in posttest and pretest score between the two groups indicated there was no statistically significant difference between groups (P = .9306). However, there was a significant improvement in the difference in posttest and pretest scores for each group (P < .0001), indicating that the culturally responsive type 2 diabetes educational content was effective in improving type 2 diabetes health literacy among both groups. This study answers a call by the World Health Organization that advocates for evidence-based mHealth interventions that offer unique opportunities for cost-effective informatics service delivery in low- and middle-income countries.

An AI-based patient-specific clinical decision support system for OA patients choosing surgery or not: study protocol for a single-centre, parallel-group, non-inferiority randomised controlled trial

BackgroundOsteoarthritis (OA) affects 20% of the adult Danish population, and the financial burden to society amounts to DKK 4.6 billion annually. Research suggests that up to 75% of surgical patients could have postponed an operation and managed with physical training. ERVIN.2 is an artificial intelligence (AI)-based clinical support system that addresses this problem by enhancing patient involvement in decisions concerning surgical knee and hip replacement. However, the clinical outcomes and cost-effectiveness of using such a system are scantily documented.ObjectiveThe primary objective is to investigate whether the usual care is non-inferior to ERVIN.2 supported care. The second objective is to determine if ERVIN.2 enhances clinical decision support and whether ERVIN.2 supported care is cost-effective.MethodsThis study used a single-centre, non-inferiority, randomised controlled in a two-arm parallel-group design. The study will be reported in compliance with CONSORT guidelines. The control group receives the usual care. As an add-on, the intervention group have access to baseline scores and predicted Oxford hip/knee scores and HRQoL for both the surgical and the non-surgical trajectory. A cost-utility analysis will be conducted alongside the trial using a hospital perspective, a 1-year time horizon and effects estimated using EQ-5D-3L. Results will be presented as cost per QALY gain.DiscussionThis study will bring knowledge about whether ERVIN.2 enhances clinical decision support, clinical effects, and cost-effectiveness of the AI system. The study design will not allow for the blinding of surgeons.Trial registrationClinicalTrials.gov NCT04332055. Registered on 2 April 2020.

783-P: When Automated Insulin Delivery Technology Meets Behavior: A Pilot Exploration of Human-Machine Coadaptation in Type 1 Diabetes

Background: Automated Insulin Delivery (AID) devices in type 1 diabetes (T1D) are becoming standard of care, and the need for adaptive AID systems is now well recognized. However, very little is known about how self-treatment behaviors should be adapted to the action of an AID system, especially with hybrid closed-loop (HCL) solutions that still require people with T1D to make several treatment decisions each day. Methods: A safety and feasibility 8-week study with a randomized two-arm parallel group design was conducted. Both control and experimental groups used a web-based simulation tool, and a commercial AID system (Control-IQ®) enhanced with an auto-titration module (ATM) that adjusted insulin therapy parameters weekly. The experimental group had access to a behavioral adaptation module (BAM) that provided up-to-date risk assessment from CGM data. Primary outcome: Safety assessment of ATM and BAM. Secondary glycemic outcomes: CGM-based metrics computed from the 2-week baseline period and last 2 weeks of treatment data. Results: Thirty Control-IQ® users completed all study procedures, 17 women and 13 men, age: 40±14 years, diabetes duration: 23±14 years, HbA1c: 6.6%±0.5%. No severe hypoglycemia, DKA, or other serious adverse events were reported. No significant changes were observed in time in 70-180 mg/dL. Changes in time in 70-140 mg/dL and mild hyperglycemia 180-250 mg/dL were significantly different between control (-3.1% and +3.1%) and experimental (+3.6% and -0.7%) groups (P=0.and 0.04) . Overnight time in 70-140 mg/dL increased significantly in the experimental group (6.8%, 95% CI [0.6%,12.9%], P=0.03) . Time &amp;lt; 70 mg/dL decreased in both groups, but significantly only in the control group (-0.9%, 95% CI [-1.6%,-0.3%], P=0.vs. -0.1%, 95% CI [-0.7%,0.5%], P=0.71) . Conclusions: Results from this pilot study suggest that combining HCL AP with behavioral adaptation feedback to the user is safe and effective. Disclosure P.Colmegna: None. R.Mcfadden: None. C.Fabris: None. B.Lobo: Other Relationship; Dexcom, Inc., Research Support; Dexcom, Inc. M.C.Oliveri: None. R.Nass: None. S.A.Brown: Research Support; Dexcom, Inc., Insulet Corporation, Roche Diagnostics USA, Tandem Diabetes Care, Inc., Tolerion, Inc. B.Kovatchev: Other Relationship; Dexcom, Inc., Johnson &amp; Johnson, Novo Nordisk, Sanofi, Research Support; Dexcom, Inc., Novo Nordisk, Tandem Diabetes Care, Inc., Speaker's Bureau; Dexcom, Inc., Tandem Diabetes Care, Inc. Funding National Institutes of Health (2R01DK085623-10)

Effectiveness of a self-regulation intervention for weight loss: A randomized controlled trial.

To evaluate effectiveness and acceptability of a novel intervention, based on self-regulation theory, for weight loss. A two-arm parallel group design was employed. Adult participants with a BMI≥30kg/m2 and the aim to lose weight were recruited and randomized to either a control or intervention group. Both groups were asked to weigh themselves daily for eight weeks. The intervention group was encouraged to use a weight tracking app, and complete daily and weekly questionnaires to prompt action planning, reflection, and evaluation of actions. Participants chose daily actions from a menu of 53 behaviours. The primary outcome was weight change after 8weeks, assessed using linear mixed effects models. At follow-up, 20 intervention group participants were interviewed regarding their experiences in the trial. 100 participants were recruited, and 98% were followed up at 8weeks. Mean weight loss was -4.18kg (SD=3.84) in the intervention compared to -1.01kg (SD=2.67) in the control group; the adjusted difference was -3.20kg (95% CI -4.49, -1.92). Participants rated the intervention's usefulness as 8.25 (SD=2.04) on a scale from 1 to 10. Adherence was a significant independent predictor of weight loss success (-1.54kg per one SD, 95% CI -2.16, -0.93), but not a mediator of the intervention effect. Participants reported that the intervention enabled them to experiment with and identify effective weight loss actions. Guiding participants through the self-regulation process was feasible, acceptable to participants, and led to significantly greater short-term weight loss than unguided self-weighing.

Music to improve sleep quality in adults with depression-related insomnia (MUSTAFI): study protocol for a randomized controlled trial

BackgroundInsomnia is a common sleep disorder for adults with depression, with major impact on their quality of life. Previous trials suggest that listening to music may be helpful in the treatment of sleep disturbances in healthy populations, including students and elderly. In addition, small studies with clinical populations of traumatized refugees, adults with chronic insomnia and adults with depression insomnia add to the evidence base. However, the impact of music listening in the treatment of depression related insomnia is not well documented.ObjectiveTo examine the efficacy of music listening on sleep quality, symptoms of depression, and quality of life in adults with depression-related insomnia.MethodA single-center randomized controlled trial (RCT) in a two-arm parallel-group design is conducted and reported according to the CONSORT guidelines. The trial consists of an experimental group and a standard care control group. Both groups receive standard treatment for depression following Danish clinical guidelines in an outpatient psychiatry unit. The experimental group listens to music for a minimum of 30 minutes at bedtime for 4 weeks.DiscussionThis trial will provide information on the efficacy of music intervention as a non-pharmacological intervention in the treatment of depression-related insomnia. This study will provide novel knowledge concerning music medicine as an evidence-based treatment for depression.Trial RegistrationClinicaltrials.gov. ID NCT03676491, registered on 19 September 2018.

Design and analysis of stratified clinical trials in the presence of bias.

BackgroundAmong various design aspects, the choice of randomization procedure have to be agreed on, when planning a clinical trial stratified by center. The aim of the paper is to present a methodological approach to evaluate whether a randomization procedure mitigates the impact of bias on the test decision in clinical trial stratified by center.MethodsWe use the weighted t test to analyze the data from a clinical trial stratified by center with a two-arm parallel group design, an intended 1:1 allocation ratio, aiming to prove a superiority hypothesis with a continuous normal endpoint without interim analysis and no adaptation in the randomization process. The derivation is based on the weighted t test under misclassification, i.e. ignoring bias. An additive bias model combing selection bias and time-trend bias is linked to different stratified randomization procedures.ResultsVarious aspects to formulate stratified versions of randomization procedures are discussed. A formula for sample size calculation of the weighted t test is derived and used to specify the tolerated imbalance allowed by some randomization procedures. The distribution of the weighted t test under misclassification is deduced, taking the sequence of patient allocation to treatment, i.e. the randomization sequence into account. An additive bias model combining selection bias and time-trend bias at strata level linked to the applied randomization sequence is proposed. With these before mentioned components, the potential impact of bias on the type one error probability depending on the selected randomization sequence and thus the randomization procedure is formally derived and exemplarily calculated within a numerical evaluation study.ConclusionThe proposed biasing policy and test distribution are necessary to conduct an evaluation of the comparative performance of (stratified) randomization procedure in multi-center clinical trials with a two-arm parallel group design. It enables the choice of the best practice procedure. The evaluation stimulates the discussion about the level of evidence resulting in those kind of clinical trials.

Improve hip fracture outcome in the elderly patient (iHOPE): a study protocol for a pragmatic, multicentre randomised controlled trial to test the efficacy of spinal versus general anaesthesia

IntroductionHip fracture surgery is associated with high in-hospital and 30-day mortality rates and serious adverse patient outcomes. Evidence from randomised controlled trials regarding effectiveness of spinal versus general anaesthesia on...

F239. THE ROLE OF DANCE/MOVEMENT THERAPY IN THE TREATMENT OF NEGATIVE SYNDROME AND PSYCHOSOCIAL FUNCTIONING OF PATIENTS WITH SCHIZOPHRENIA: RESULT FROM A PILOT MIXED METHODS INTERVENTION STUDY WITH EXPLANATORY INTENT

BackgroundOptimizing psychosocial functioning and overall well-being by reducing the severity of negative symptoms are important outcomes for individuals with schizophrenia. Movement-based therapeutic approaches are uniquely capable of addressing the non-verbal nature of negative symptoms. Dance/Movement Therapy (DMT), a promising treatment for mental health conditions such as schizophrenia, has been found to reduce the occurrence and severity of negative symptoms and to have a positive impact on the psychosocial functioning. Although preliminary findings suggest DMT as a treatment intervention, limited research and inconclusive findings preclude generalizations and more research is needed. We aimed to examine the treatment effects of a 10-week (20 sessions) group DMT treatment program.MethodsWe employed a mixed methods intervention design with explanatory intent, in which a randomized controlled trial is followed by semi-structured exit interviews. Thirty-one severely ill individuals diagnosed with schizophrenia participated in the RCT that used a two-arm parallel group design to assess and show the difference between patients receiving standard care (SC) and patients receiving standard care plus DMT on measures of negative symptoms (as primary outcome; PANSS, BNSS) and psychosocial functioning (as secondary outcomes; WHO-DAS 2.0, SDS). Quantitative measures were taken pre and post- intervention. Participants who participated in a minimum of 50% of DMT sessions (n=15) were invited to an exit interview. This criterion was also used to analyze quantitative data, leaving n=28 for quantitative analysis.ResultsAll participants in both groups (n=31) completed the study. Because of such a small sample size (n=28) and a pilot nature of the study we were restricted to use descriptive statistics.The quantitative data suggest that DMT and SC were not equally effective in enhancing primary outcomes. Analysis of the PANSS mean score changes showed a slight increase in the negative symptom in the DMT from 28.33 ± 4.76 to 29.00 ± 4.10, and slight decrease in the SC from 28.92 ± 5.72 to 27.08 ± 5.64. BNSS scores indicate that both groups improved. SC participants reported grater reduction on BNSS overal score from 53.31 ± 11.48 to 47.77 ± 8.10 in comparison to DMT from 53.07 ± 7.27 to 51.93 ± 6.18. However, DMT participants reported reduction of symptoms in distress, antisocial activity, avolition and verbal expression.Analysis of WHO-DAS suggests that DMT was effective in reduction of disability severity compared to SC. DMT participants reported grater improvement in cognition, mobility, self-care, and getting along. Both groups reported reduction of the impact of difficulties on daily functioning on SDS, however DMT participants reported a greater reduction in days during which they were completely unable to perform or had to limit their usual activities or work due to symptoms. In the SC, the results suggest a reduction in the number of days lost and days of lower productivity.Qualitative findings identified participants’ experiences and the most important themes related to benefits of the DMT intervention: enhanced activation, motivation, socialization, and self-awareness.DiscussionResults of this study contribute to knowledge about body-based interventions for schizophrenia and indicate that DMT had an effect on participants psychosocial functioning and coping with negative symptoms. Integration of quantitative and qualitative data provides a wider perspective by gaining a better understanding of the treatment outcomes and explaining inconclusive results. Findings of this study set the stage for larger fully powered research, examining intervention methods and procedures, as well as treatment effects, more thoroughly.

Evaluation of piezocision and laser-assisted flapless corticotomy in the acceleration of canine retraction: a randomized controlled trial

BackgroundTo evaluate the effectiveness of two minimally invasive surgical procedures in the acceleration of canine retraction: piezocision and laser-assisted flapless corticotomy (LAFC).MethodsTrial design: A single-centre randomized controlled trial with a compound design (two-arm parallel-group design and a split-mouth design for each arm).Participants: 36 Class II division I patients (12 males, 24 females; age range: 15 to 27 years) requiring first upper premolars extraction followed by canine retraction.Interventions: piezocision group (PG; n = 18) and laser-assisted flapless corticotomy group (LG; n = 18). A split-mouth design was applied for each group where the flapless surgical intervention was randomly allocated to one side and the other side served as a control side.Outcomes: the rate of canine retraction (primary outcome), anchorage loss and canine rotation, which were assessed at 1, 2, 3 and 4 months following the onset of canine retraction. Also the duration of canine retraction was recorded.Random sequence: Computer-generated random numbers.Allocation concealment: sequentially numbered, opaque, sealed envelopes.Blinding: Single blinded (outcomes’ assessor).ResultsSeventeen patients in each group were enrolled in the statistical analysis. The rate of canine retraction was significantly greater in the experimental side than in the control side in both groups by two-fold in the first month and 1.5-fold in the second month (p < 0.001). Also the overall canine retraction duration was significantly reduced in the experimental side as compared with control side in both groups about 25% (p ≤ 0.001). There were no significant differences between the experimental and the control sides regarding loss of anchorage and upper canine rotation in both groups (p > 0.05). There were no significant differences between the two flapless techniques regarding the studied variables during all evaluation times (p > 0.05).ConclusionsPiezocision and laser-assisted flapless corticotomy appeared to be effective treatment methods for accelerating canine retraction without any significant untoward effect on anchorage or canine rotation during rapid retraction.Trials registrationClinicalTrials.gov (Identifier: NCT02606331).

The influence of norepinephrine and phenylephrine on cerebral perfusion and oxygenation during propofol\u2013remifentanil and propofol\u2013remifentanil\u2013dexmedetomidine anaesthesia in piglets

BackgroundVasopressors are frequently used to increase blood pressure in order to ensure sufficient cerebral perfusion and oxygenation (CPO) during hypotensive periods in anaesthetized patients. Efficacy depends both on the vasopressor and anaesthetic protocol used. Propofol–remifentanil total intravenous anaesthesia (TIVA) is common in human anaesthesia, and dexmedetomidine is increasingly used as adjuvant to facilitate better haemodynamic stability and analgesia. Little is known of its interaction with vasopressors and subsequent effects on CPO. This study investigates the CPO response to infusions of norepinephrine and phenylephrine in piglets during propofol–remifentanil and propofol–remifentanil–dexmedetomidine anaesthesia. Sixteen healthy female piglets (25–34 kg) were randomly allocated into a two-arm parallel group design with either normal blood pressure (NBP) or induced low blood pressure (LBP). Anaesthesia was induced with propofol without premedication and maintained with propofol–remifentanil TIVA, and finally supplemented with continuous infusion of dexmedetomidine. Norepinephrine and phenylephrine were infused in consecutive intervention periods before and after addition of dexmedetomidine. Cerebral perfusion measured by laser speckle contrast imaging was related to cerebral oxygenation as measured by an intracerebral Licox probe (partial pressure of oxygen) and transcranial near infrared spectroscopy technology (NIRS) (cerebral oxygen saturation).ResultsDuring propofol–remifentanil anaesthesia, increases in blood pressure by norepinephrine and phenylephrine did not change cerebral perfusion significantly, but cerebral partial pressure of oxygen (Licox) increased following vasopressors in both groups and increases following norepinephrine were significant (NBP: P = 0.04, LBP: P = 0.02). In contrast, cerebral oxygen saturation (NIRS) fell significantly in NBP following phenylephrine (P = 0.003), and following both norepinephrine (P = 0.02) and phenylephrine (P = 0.002) in LBP. Blood pressure increase by both norepinephrine and phenylephrine during propofol–remifentanil–dexmedetomidine anaesthesia was not followed by significant changes in cerebral perfusion. Licox measures increased significantly following both vasopressors in both groups, whereas the decreases in NIRS measures were only significant in the NBP group.ConclusionsCerebral partial pressure of oxygen measured by Licox increased significantly in concert with the vasopressor induced increases in blood pressure in healthy piglets with both normal and low blood pressure. Cerebral oxygenation assessed by intracerebral Licox and transcranial NIRS showed opposing results to vasopressor infusions.

Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID): a randomised controlled trial in systemic cancer treatment

BackgroundeRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) is an internet based system for patients to self-report symptoms and side effects (adverse events or AE) of cancer treatments. eRAPID allows AE reporting from home and patient reported data is accessible via Electronic Patient Records (EPR) for use in routine care. The system can generate alerts to clinical teams for severe AE and provides patient advice on managing mild AEs. The overall aims of eRAPID are to improve the safe delivery of cancer treatments, enhance patient care and standardise AE documentation.MethodsThe trial is a prospective randomised two-arm parallel group design study with repeated measures and mixed methods. Participants (adult patients with breast cancer on neo-adjuvant or adjuvant chemotherapy, colorectal and gynaecological cancer receiving chemotherapy) are randomised to receive the eRAPID intervention or usual care over 18 weeks of treatment. Participants in the intervention arm receive training in using the eRAPID system to provide routine weekly adverse event reports from home. Hospital staff can access eRAPID reports via the EPR and use the information during consultations or phone calls with patients.Prior to commencing the full trial an internal pilot phase was conducted (N = 87 participants) to assess recruitment procedures, consent and attrition rates, the integrity of the intervention information technology and establish procedures for collecting outcome data. The overall target sample for the trial is N = 504.The primary outcome of the trial is quality of life (FACT-G) with secondary outcomes including health economics (costs to patients and the NHS), process of care (e.g. contacts with the hospital, number of admissions, clinic appointments and changes to treatment/medications) and patient self-efficacy. Outcome data is collected at baseline, 6, 12, 18 weeks and 12 months. The intervention is also being evaluated via end of study interviews with patient participants and clinical staff.DiscussionThe pilot phase was completed in February 2016 and recruitment and attrition rates met criteria for continuing to the full trial. Recruitment recommenced in May 2016 and is planned to continue until December 2017. Overall findings will determine the value of the eRAPID intervention for supporting the care of patients receiving systemic cancer treatment.Trial registrationCurrent Controlled Trials ISRCTN88520246. Registered 11 September 2014.

Effects of community-based group music therapy for children exposed to ongoing child maltreatment & poverty in South Korea: A block randomized controlled trial

The purpose of this study was to investigate the effects of Community-Based Group Music Therapy on internalizing behavioral problems in children who were exposed to ongoing child maltreatment and poverty in South Korea. It was a block randomized controlled trial with a two-arm parallel group design, comparing group music therapy (n=14) to standard care (n=12). The children in the music therapy group received 12 consecutive group music therapy sessions once a week whereas the children in standard care had care-as-usual (aged seven to 12). The internalizing behavioral problems of the Child Behavior Checklist, both teacher and child reports were used to measure behavioral changes over time in both groups at baseline, pre and post interventions. Results were collected and analyzed using repeated measures ANCOVA.

The effectiveness of manual-guided, problem-solving-based self-learning programme for family caregivers of people with recent-onset psychosis: A randomised controlled trial with 6-month follow-up

BackgroundFamily intervention for psychotic disorders is an integral part of psychiatric treatment with positive effects on patients’ mental state and relapse rate. However, the effect of such family-based intervention on caregivers’ psychological distress and well-being, especially in non-Western countries, has received comparatively much less attention. ObjectivesTo test the effects of guided problem-solving-based manual-guided self-learning programme for family caregivers of adults with recent-onset psychosis over a 6-month period of follow-up, when compared with those in usual family support service. DesignA single-centre randomised controlled trial, which was registered at ClinicalTrials.gov (NCT02391649), with a repeated-measures, two-arm (parallel-group) design. SettingsOne main psychiatric outpatient clinic in the New Territories of Hong Kong. ParticipantsA random sample of 116 family caregiverss of adult outpatients with recent-onset psychosis. MethodsFollowing pre-test measurement, caregivers were assigned randomly to one of two study groups: a 5-month self-help, problem-solving-based manual-guided self-learning (or bibliotherapy) programme (in addition to usual care), or usual family support service only. Varieties of patient and caregiver health outcomes were assessed and compared at baseline and at 1-week and 6-month post-intervention. ResultsOne hundred and eleven (96%) caregivers completed the 6-month follow-up (two post-tests); 55 of them (95%) completed ≥4 modules and attended ≥2 review sessions (i.e., 75% of the intervention). The family participants’ mean age was about 38 years and over 64% of them were female and patient's parent or spouse. Multivariate analyses of variance indicated that the manual-guided self-learning group reported significantly greater improvements than the usual care group in family burden [F(1,110)=6.21, p=0.006] and caregiving experience [F(1,110)=6.88, p=0.0004], and patients’ psychotic symptoms [F(1,110)=6.25, p=0.0003], functioning [F(1,110)=7.01, p=0.0005] and number of hospitalisations [F(1,110)=5.71, p=0.005] over 6-month follow-up. ConclusionsProblem-solving-based, manual-guided self-learning programme for family caregivers of adults with recent-onset psychosis can be an effective self-help programme and provide medium-term benefits to patients’ and caregivers’ mental health and duration of patients’ re-hospitalisations.

Eight Weeks of Cosmos caudatus (Ulam Raja) Supplementation Improves Glycemic Status in Patients with Type 2 Diabetes: A Randomized Controlled Trial.

Objectives. Optimizing glycemic control is crucial to prevent type 2 diabetes related complications. Cosmos caudatus is reported to have promising effect in improving plasma blood glucose in an animal model. However, its impact on human remains ambiguous. This study was carried out to evaluate the effectiveness of C. caudatus on glycemic status in patients with type 2 diabetes. Materials and Methods. In this randomized controlled trial with two-arm parallel-group design, a total of 101 subjects with type 2 diabetes were randomly allocated to diabetic-ulam or diabetic controls for eight weeks. Subjects in diabetic-ulam group consumed 15 g of C. caudatus daily for eight weeks while diabetic controls abstained from taking C. caudatus. Both groups received the standard lifestyle advice. Results. After 8 weeks of supplementation, C. caudatus significantly reduced serum insulin (−1.16 versus +3.91), reduced HOMA-IR (−1.09 versus +1.34), and increased QUICKI (+0.05 versus −0.03) in diabetic-ulam group compared with the diabetic controls. HbA1C level was improved although it is not statistically significant (−0.76% versus −0.37%). C. caudatus was safe to consume. Conclusions. C. caudatus supplementation significantly improves insulin resistance and insulin sensitivity in patients with type 2 diabetes.

Evaluation of a practice team-supported exposure training for patients with panic disorder with or without agoraphobia in primary care - study protocol of a cluster randomised controlled superiority trial

BackgroundPanic disorder and agoraphobia are debilitating and frequently comorbid anxiety disorders. A large number of patients with these conditions are treated by general practitioners in primary care. Cognitive behavioural exposure exercises have been shown to be effective in reducing anxiety symptoms. Practice team-based case management can improve clinical outcomes for patients with chronic diseases in primary care. The present study compares a practice team-supported, self-managed exposure programme for patients with panic disorder with or without agoraphobia in small general practices to usual care in terms of clinical efficacy and cost-effectiveness.Methods/DesignThis is a cluster randomised controlled superiority trial with a two-arm parallel group design. General practices represent the units of randomisation. General practitioners recruit adult patients with panic disorder with or without agoraphobia according to the International Classification of Diseases, version 10 (ICD-10). In the intervention group, patients receive cognitive behaviour therapy-oriented psychoeducation and instructions to self-managed exposure exercises in four manual-based appointments with the general practitioner. A trained health care assistant from the practice team delivers case management and is continuously monitoring symptoms and treatment progress in ten protocol-based telephone contacts with patients. In the control group, patients receive usual care from general practitioners. Outcomes are measured at baseline (T0), at follow-up after six months (T1), and at follow-up after twelve months (T2). The primary outcome is clinical severity of anxiety of patients as measured by the Beck Anxiety Inventory (BAI). To detect a standardised effect size of 0.35 at T1, 222 patients from 37 general practices are included in each group. Secondary outcomes include anxiety-related clinical parameters and health-economic costs.Trial registrationCurrent Controlled Trials [http://ISCRTN64669297]

The effects of group music therapy on aggressive and delinquent behaviors in children who experienced on-going child abuse and poverty : A Randomized Controlled Study

The study investigated the effects of group music therapy on aggressive and delinquent behaviors of children who were exposed to on-going child maltreatment and poverty. The study employed a two-arm parallel group design in which a music therapy is compared to a waiting group to determine behavioral changes over time. The results were mixed with no statistical significant difference between waiting and music therapy groups. The implication of these findings is discussed further. .

Heavy silicone oil versus standard silicone oil in as vitreous tamponade in inferior PVR (HSO Study): interim analysis

The Heavy Silicone Oil versus Standard Silicone Oil Study (HSO study) is designed to answer the question whether a heavier-than-water tamponade improves the prognosis of eyes with proliferative vitreoretinopathy (PVR) of the lower retina. The HSO Study is a multicentre, randomized, prospective, controlled clinical trial stratified by surgeon comparing two endotamponades within a two-arm parallel-group design. Patients with inferiorly and posteriorly located PVR grade C-A6 were randomized to either HSO or standard silicone oil as a tamponading agent. The main end-point criteria are complete retinal attachment at 12 months and change in visual acuity (VA) 12 months postoperatively compared to the preoperative VA. Forty-six patients treated with HSO were compared to 47 patients treated with standard silicone oil. There was no difference among the groups regarding baseline data. Three patients in the HSO and five patients in the standard silicone oil group fulfilled intraoperative exclusion criteria. There was no significant difference between both groups regarding anatomical success. Neither noninferiority nor superiority was shown with regard to final acuity. The HSO Study is the first randomized prospective clinical trial to compare heavy and standard silicone oil in patients with PVR of the lower retina. The intermediate results failed to demonstrate superiority of a heavy tamponade.

How do multi-stage, multi-arm trials compare to the traditional two-arm parallel group design – a reanalysis of 4 trials

BackgroundTo speed up the evaluation of new therapies, the multi-arm, multi-stage trial design was suggested previously by the authors.MethodsIn this paper, we evaluate the performance of the two-stage, multi-arm design using four cancer trials conducted at the MRC CTU. The performance of the design at fictitious interim analyses is assessed using a conditional bootstrap approach.ResultsTwo main aims are addressed: the error rate of correctly carrying on/stopping the trial at an interim analysis as well as quantifying the gains in terms of resources by employing this design. Furthermore, we make suggestions for the best timing of this interim analysis.ConclusionMulti-arm, multi-stage trials are an effective way of speeding up the therapy evaluation process. The design performs well in terms of the type I and II error rates.

Heavy silicone oil versus standard silicone oil as vitreous tamponade in inferior PVR (HSO Study): design issues and implications

Proliferative vitreoretinopathy (PVR) is the most important reason for blindness following retinal detachment. Presently, vitreous tamponades such as gas or silicone oil cannot contact the lower part of the retina. A heavier-than-water tamponade displaces the inflammatory and PVR-stimulating environment from the inferior area of the retina. The Heavy Silicone Oil versus Standard Silicone Oil Study (HSO Study) is designed to answer the question of whether a heavier-than-water tamponade improves the prognosis of eyes with PVR of the lower retina. The HSO Study is a multicentre, randomized, prospective controlled clinical trial comparing two endotamponades within a two-arm parallel group design. Patients with inferiorly and posteriorly located PVR are randomized to either heavy silicone oil or standard silicone oil as a tamponading agent. Three hundred and fifty consecutive patients are recruited per group. After intraoperative re-attachment, patients are randomized to either standard silicone oil (1000 cSt or 5000 cSt) or Densiron((R)) as a tamponading agent. The main endpoint criteria are complete retinal attachment at 12 months and change of visual acuity (VA) 12 months postoperatively compared with the preoperative VA. Secondary endpoints include complete retinal attachment before endotamponade removal, quality of life analysis and the number of retina affecting re-operation within 1 year of follow-up. The design and early recruitment phase of the study are described. The results of this study will uncover whether or not heavy silicone oil improves the prognosis of eyes with PVR.