Randomized Control Pilot Study Research Articles

Protocol for a pragmatic randomised controlled trial to evaluate effects of a brief intervention for emergency department attendees who present with moderate or high levels of non-specific psychological distress: a pilot study.

BackgroundScreening and brief intervention in the emergency department (ED) has almost exclusively focused on individuals with alcohol-use problems. The early detection of mental health problems before problems become severe will enable early intervention and support which may improve health and prevent further deterioration. The main aim of this pilot study is to provide evidence of the acceptance of a telephone intervention aimed at ED attendees with moderate or high psychological distress. This will be determined by recruitment rates, retention rates and participant satisfaction with the intervention. Secondary outcomes include whether socio-demographic variables have an impact on retention rates, and whether the intervention had any impact on psychological distress.Methods/DesignThis study will be a single-site pragmatic randomised controlled pilot study. Consenting ED attendees will be screened with the Kessler Psychological Distress Scales (K10). There will be three arms to the study: a moderate/high psychological distress group with or without intervention, and a low psychological distress group. Those with severe psychological distress will be excluded. All included participants will be followed-up at 1, 3, 6 and 12 months post-recruitment. Retention rates will be determined by successful completion of surveys at the follow-up time-points. Psychological distress will be measured by the K10 at all follow-up time-points.DiscussionThis study will provide information regarding the potential for screening and recruitment at an opportunistic hospital presentation. It will provide data for a future larger study with regard to participants accepting to be included in this study. Participant acceptability will be measured in terms of recruitment rates and retention rates measured by successful follow-ups over the following 12 months post-recruitment.Trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12614000031662. Registered 10/01/2014.

Feasibility of a patient-centred nutrition intervention to improve oral intakes of patients at risk of pressure ulcer: a pilot randomised control trial.

Nutrition is important for pressure ulcer prevention. This randomised control pilot study assessed the feasibility of conducting a larger trial to test the effectiveness of a patient-centred intervention for improving the dietary intakes of patients at risk of pressure ulcer in hospital. A 3-day intervention targeting patients at risk of pressure ulcer was developed, based on three main foundations: patient education, patient participation and guided goal setting. The intervention was piloted in three wards in a metropolitan hospital in Queensland, Australia. Participants were randomised into control or intervention groups and had their oral intakes monitored. A subset of intervention patients was interviewed on their perceptions of the intervention. Feasibility was tested against three criteria: ≥75% recruitment; ≥80% retention; and ≥80% intervention fidelity. Secondary outcomes related to effects on energy and protein intakes. Eighty patients participated in the study and 66 were included in final analysis. The recruitment rate was 82%, retention rate was 88%, and 100% of intervention patients received the intervention. Patients viewed the intervention as motivating and met significantly more of their estimated energy and protein requirements over time. This pilot study indicates that the intervention is feasible and acceptable by patients at risk of pressure ulcer. A larger trial is needed to confirm the effectiveness of the intervention in the clinical setting.

Role of atrial fibrillation burden in assessing thromboembolic risk.

Stroke represents the most devastating complication of atrial fibrillation (AF). Our understanding of the pathophysiology of thromboembolism in patients with AF remains incomplete, and as such, our assessment and management of this risk is imperfect. Current guidelines regard the risk of thromboembolism as independent of the frequency or duration of AF.1 Paradoxically, standard practice in the pericardioversion period considers thromboembolic risk to accrue after 48 hours of AF.1 This recommendation, however, is based on limited data, including an observational study of 357 patients which demonstrated that the risk of thromboembolic events was <1% in patients with AF lasting <48 hours who cardioverted without prolonged anticoagulation therapy or a transesophageal echocardiogram.2 No strong randomized control trial data exist to specifically support a 48-hour safety cut-off, and recent data suggest that the duration of AF associated with a significantly increased risk of stroke may in fact be less.3–8 The emergence of technology to allow absolute quantification of the frequency and duration, or burden, of AF offers the opportunity to refine our assessment and management of thromboembolic risk associated with AF. It has been 200 years since William Wood described a ball thrombus in the left atrium of a patient with mitral stenosis9 and 170 years since Virchow identified the critical components required for thrombus formation.10 It took until 1930 for Harvey and Levine to first declare that “auricular fibrillation definitely increases the incidence of auricular thrombosis” in an autopsy series of patients with mural thrombi.11 Uncertainty as to whether nonrheumatic AF resulted in stroke continued for the next 40 plus years until Wolfe and colleagues, in their landmark analysis using the Framingham population data, identified a 5.6-fold increased risk of stroke in patients with chronic nonvalvular AF.12 With time it would become …

Recruitment and initial interest of men in yoga for smoking cessation: QuitStrong, a randomized control pilot study.

Innovative treatments like yoga for men's smoking cessation (SC) are lacking. To examine the feasibility and acceptability of yoga for men's SC. We randomly assigned eligible men (smoker, ≥5 cigarettes/day, age 18-65) to receive cognitive behavioral therapy for SC, plus a yoga or wellness program. Measures included feasibility (recruitment, class attendance) and acceptability (customer satisfaction). We enrolled 38 of 49 eligible men of 167 screened in response to ads (mean age 39.9 years, ±13.7) who smoked on average 18.6 cigarettes/day (±8.3). Wellness (75.8 %) versus yoga (56 %) men attended more SC classes, p < 0.01. Sixty percent attended ≥1 yoga class. Men reported greater satisfaction with in-house versus community yoga classes. Wellness appears to be the preferred intervention; results indicated that it may be more feasible and showed increased attendance at smoking classes. To be fully feasible, yoga + SC may need to be a unified program offering all classes tailored for men and in the same location.

O-084 Ursodeoxycholic Acid For Parenteral Nutrition Associated Liver Disease In Neonates: A Randomised Controlled Pilot Study

Background In neonates, parenteral nutrition associated liver disease (PNALD) is a well-documented complication. Few retrospective studies suggested that ursodeoxycholic acid (UDCA) may shorten cholestasis duration. Objectives To evaluate the effect of UDCA treatment on the duration and severity of PNALD. Design/methods A double blinded randomised controlled pilot study in a level III NICU. PNALD was defined as at least 2 values of conjugated bilirubin ≥ 34 μmol/L. UDCA or placebo was started after randomization within 72 h of the diagnosis. Exclusion criteria included biliary tract anomalies, TORCH infection, short bowel syndrome, congenital hypothyroid, urinary tract infection, and congenital metabolic or genetic disorders. Baseline characteristics, clinical and biochemical evolution information were collected. Student’s T test, Chi-squared or Fisher’s exact test were used as appropriate. p Results After consent, 26 infants were recruited (14 placebo and 12 UDCA). Table1 shows baseline characteristics. In the intention to treat analysis, there was no difference in the duration of cholestasis between groups. In the per protocol analysis (after excluding 2 deaths and one transfer in the placebo group, 4 deaths and one exclusion criteria violation in the UDCA group) the duration of cholestasis was significally shorter in the UDCA group. Figures1, 2 show the effect of UDCA on the duration of cholestasis and the maximum values of hepatic markers. No adverse reactions were associated with UDCA treatment. Conclusion In neonates, treatment with UDCA decreases the duration of cholestasis. The UDCA group showed lower maximum hepatic transaminases levels indicating possible hepatic protective effect.

PO-0588 Neonatal Outcomes Of Very Low Birth Weight Infants Who Received Enteral Nutrition With And Without Olive Oil Support: Randomised Controlled Pilot Study

Background and aims Very low birth weight (VLBW) infants have a greater risk for the oxidative stress related diseases (OSRDs) like retinopathy of prematurity, bronchopulmonary dysplasia, periventricular leukomalacia and necrotizing enterocolitis. Naturel antioxidant activity of phenols, flavonoid and tocopherols in extra virgin olive oil (EVOO) may be preventive for the OSRDs. The purpose of conducting a randomised controlled pilot study is to compare the weight gaining, length of hospitalisation and the OSRDs of VLBW infants who received early enteral nurtition with and without EVOO support. Methods VLBW newborns were divided into two groups in this pilot study. Group 1 received enteral nutrition and EVOO, Group 2 received only enteral nutrition. Nutritional analysis was undertaken for EVOO that was added as 0.5 ml/day in 100 ml enteral nutrition. Total parenteral nutrition (TPN) and minimal enteral nutrition was initiated both of two groups. Results A total of 26 VLBW infants were divided into two groups (Group 1)(n = 13) and (Group 2) (n = 13) and assessed the birth weight: Group 1= 1,329 ± 35 g, Group 2 = 1,276 ± 32 g. gestational age: Group 1= 31 ± 2.79, Group 2 =29 ± 2 weeks. There was no significant difference between two groups for weight gaining, length of hospitalisation and the OSRDs. Conclusions EVOO is very important natural antioxidant and anti-inflammatory nutrients for preterm infants particularly VLBW. A larger randomised controlled trials are needed to show the antioxidant and anti-inflammatory effects of olive oil for prevention of OSRDs in this high risk group.

Does Teaching Crisis Resource Management Skills Improve Resuscitation Performance in Pediatric Residents?*

The effect of teaching crisis resource management skills on the resuscitation performance of pediatric residents is unknown. The primary objective of this pilot study was to determine if teaching crisis resource management to residents leads to improved clinical and crisis resource management performance in simulated pediatric resuscitation scenarios. A prospective, randomized control pilot study. Simulation facility at tertiary pediatric hospital. Junior pediatric residents. Junior pediatric residents were randomized to 1 hour of crisis resource management instruction or no additional training. Time to predetermined resuscitation tasks was noted in simulated resuscitation scenarios immediately after intervention and again 3 months post intervention. Crisis resource management skills were evaluated using the Ottawa Global Rating Scale. Fifteen junior residents participated in the study, of which seven in the intervention group. The intervention crisis resource management group placed monitor leads 24.6 seconds earlier (p = 0.02), placed an IV 47.1 seconds sooner (p = 0.04), called for help 50.4 seconds faster (p = 0.03), and checked for a pulse after noticing a rhythm change 84.9 seconds quicker (p = 0.01). There was no statistically significant difference in time to initiation of cardiopulmonary resuscitation (p = 0.264). The intervention group had overall crisis resource management performance scores 1.15 points higher (Ottawa Global Rating Scale [out of 7]) (p = 0.02). Three months later, these differences between the groups persisted. A 1-hour crisis resource management teaching session improved time to critical initial steps of pediatric resuscitation and crisis resource management performance as measured by the Ottawa Global Rating Scale. The control group did not develop these crisis resource management skills over 3 months of standard training indicating that obtaining these skills requires specific education. Larger studies of crisis resource education are required.

Impact of implementation of a novel antimicrobial stewardship tool on antibiotic use in nursing homes: a prospective cluster randomized control pilot study.

To evaluate the impact of 'Resident Antimicrobial Management Plan' (RAMP), a novel antimicrobial stewardship tool on systemic antibiotic use for treatment of infection in nursing homes (NHs). A pilot cluster randomized control study was conducted in 30 NHs in London. Pre-intervention, we collected point prevalence data on antimicrobial use on three occasions and total antimicrobial consumption for a 12 week period. Post-intervention data were collected in the same manner and included assessment of compliance with RAMP in the intervention group (IG). The number of residents included was 1628 pre-intervention [825 IG/803 control group (CG)] and 1610 post-intervention (838 IG/772 CG). The corresponding pre- and post-intervention point prevalence of systemic antibiotic prescribing for treatment of infection was 6.46% and 6.52% in the IG [estimated prevalence ratio: 1.01 (95% CI: 0.81-1.25), P = 0.94] compared with 5.27% and 5.83%, respectively, in the CG [estimated prevalence ratio: 1.11 (95% CI: 0.87-1.41), P = 0.4]. Total antibiotic consumption was 69.78 defined daily doses/1000 residents/day (DRD) pre-intervention and 66.53 DRD post-intervention in the IG compared with 49.68 and 51.92 DRD, respectively, in the CG. There was a significant decrease of 4.9% (3.25 DRD) in the IG (95% CI: 1.0%-8.6%) (P = 0.02) compared with a significant increase of 5.1% (2.24 DRD) in the CG (95% CI: 0.2%-10.2%) (P = 0.04). Main indications for antibiotics were lower respiratory tract infections (34.1%), urinary tract infections (28.5%) and skin/soft tissue infections (25.1%). This pilot study demonstrated that use of RAMP was associated with a statistically significant decrease in total antibiotic consumption and has the potential to be an important antimicrobial stewardship tool for NHs.

Evaluation of a polyacrylamide hydrogel in the treatment of induced osteoarthritis in a goat model: a randomized controlled pilot study

Evaluation of a polyacrylamide hydrogel in the treatment of induced osteoarthritis in a goat model: a randomized controlled pilot study

Probiotic treatment for the prevention of antibiotic-associated diarrhoea in geriatric patients: A multicentre randomised controlled pilot study

The objective of the study was to evaluate effectiveness of probiotic supplementation in reducing antibiotic-associated diarrhoea (AAD). A double-blind randomised controlled trial (registration number: ACTRN 12609000429257); with primary outcome prevention of AAD and secondary outcome reduction in diarrhoea duration, patients were randomised to receive probiotic supplementation with Lactobacillus casei, Shirota strain or placebo. Eighty-seven people (66-101 years old) were recruited to the study during their admission to the Geriatric Evaluation Management wards during August-October 2009. 41 received the active Yakult (Yakult Australia Pty Ltd, Dandenong South, Victoria, Australia) (12.2% diarrhoea) and 46 received placebo (8.7% diarrhoea). There was no significant difference in diarrhoea between the groups, Fisher's exact test, P = 0.729. The mean diarrhoea duration was 4 and 5 days for those administered Yakult and placebo, respectively. There was no significant difference between groups. However, we noted a low prevalence of AAD and this affects the sample size that will be required for any future study examining a beneficial effect of probiotic supplementation.

A Brain-Computer Interface Based Cognitive Training System for Healthy Elderly: A Randomized Control Pilot Study for Usability and Preliminary Efficacy

Cognitive decline in aging is a pressing issue associated with significant healthcare costs and deterioration in quality of life. Previously, we reported the successful use of a novel brain-computer interface (BCI) training system in improving symptoms of attention deficit hyperactivity disorder. Here, we examine the feasibility of the BCI system with a new game that incorporates memory training in improving memory and attention in a pilot sample of healthy elderly. This study investigates the safety, usability and acceptability of our BCI system to elderly, and obtains an efficacy estimate to warrant a phase III trial. Thirty-one healthy elderly were randomized into intervention (n = 15) and waitlist control arms (n = 16). Intervention consisted of an 8-week training comprising 24 half-hour sessions. A usability and acceptability questionnaire was administered at the end of training. Safety was investigated by querying users about adverse events after every session. Efficacy of the system was measured by the change of total score from the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) before and after training. Feedback on the usability and acceptability questionnaire was positive. No adverse events were reported for all participants across all sessions. Though the median difference in the RBANS change scores between arms was not statistically significant, an effect size of 0.6SD was obtained, which reflects potential clinical utility according to Simon’s randomized phase II trial design. Pooled data from both arms also showed that the median change in total scores pre and post-training was statistically significant (Mdn = 4.0; p<0.001). Specifically, there were significant improvements in immediate memory (p = 0.038), visuospatial/constructional (p = 0.014), attention (p = 0.039), and delayed memory (p<0.001) scores. Our BCI-based system shows promise in improving memory and attention in healthy elderly, and appears to be safe, user-friendly and acceptable to senior users. Given the efficacy signal, a phase III trial is warranted.Trial RegistrationClinicalTrials.gov NCT01661894

The Preliminary Effects of a Primary Care–Based Randomized Treatment Trial With Overweight and Obese Young Children and Their Parents

IntroductionTwenty-three percent of preschoolers are overweight/obese, which puts these children at risk for the development of chronic health comorbidities. The purpose of this randomized control pilot study was to determine the feasibility and preliminary effects of a theoretically based, primary care intervention on the physical outcomes of 60 overweight/obese preschool/early school-aged 4- to 8-year-old children. MethodsAfter recruitment and baseline assessment, parent-child dyads were randomly assigned to either the treatment or the control condition. Four intervention sessions were conducted with the parents in their child's primary health care office. The impact of the intervention was evaluated by assessing child anthropometric measures (e.g., waist, waist-by-height ratio, and body mass index [BMI]) immediately, 3 months, and 6 months after the intervention period. ResultsAnalysis of variance models suggested that children in the experimental group were found to have reduced waist circumference and waist-by-height ratio immediately after the intervention that persisted for 3 and 6 months (f = 0.33, 0.35, respectively). BMI and BMI percentile were not differentially affected. DiscussionThese promising findings suggest that a primary care–based, parent-focused overweight/obesity treatment program is feasible and demonstrated positive preliminary effects, improving the children's overall health trajectory.

The effects of omega-3 fish oil infusion on the T-regulatory cells in patients with severe acute pancreatitis: A randomised control pilot study

Introduction: A balance between pro-inflammatory and regulatory immune responses determines the outcome in Severe Acute Pancreatitis (SAP). Failure to regulate the inflammatory response can leads to the development of multiple organ dysfunction. Omega-3 has shown to modulate the pro-inflammatory cytokines in SAP. The aim of this study is to examine the role of Omega-3 fish oil on T-regulatory cells. Methods: Forty-four patients with predicted SAP were randomly and blindly allocated to receive daily an omega-3 fish-oil infusion (Lipidem 20%, BBraun)(n1⁄422) or a similar infusion but without omega-3 fish-oil (Lipofundin MCT 20%, BBraun)(n1⁄422). Infusions were initiated within 3 days of the onset of the symptoms and for a maximum of 7 days. A peripheral bloodmononuclear cell (PBMC) was obtained on days 0,1, 3 and 7 of the infusion. Subsequently, T-cells were isolated by flow cytometric cell sorting on a FACSAria (BD Biosciences). Results On admission, there were no significant differences between both groups on the expressions of CD4, CD25, Fox P3, CD4+ CD25+ Fox P3-, CD4+ CD25+ Fox P3+, CD4+ CD25Fox P3+, CD4+ CD25Fox P3+, p1⁄40.259, 0.164, 0.155, 0.934, 0.179, 0.133 and 0.884, respectively. On day 7-post infusion, trends towards positive Fox P3 T-cells phenotypes were observed in the fish-oil group, p1⁄4>0.05. Conclusion: This preliminary study suggests that omega-3 fish can modify T-cells through the expression of the Fox P3+ T-cells phenotypes. Further studies are required to establish these findings. Take-home message: Omega-3 fish oil improves the activity of regulatory cells. Abstract previously presented? no () Any disclosures? yes (D. Al-Leswas: Grant/Research Support from B Braun, W.-Y. Chung: None declared. L. Howells: none declared, A. Eltweri: None declared, A. Arshad: Grant/Research Support from B Braun, C. Pollard: None declared, O. Al-Taan: Grant/Research Support from B Braun, G. Garcea: None declared, M. Metcalfe: Grant/ Research Support from B Braun, A. Dennison: Grant/Research Support from B Braun)

Feasibility and Efficacy of Willpower Strengthening Exercises with University Students: A Randomised Control Pilot Study

This study examined the feasibility and efficacy of implementing intense brief willpower strengthening exercises with university students. Thirty-nine university students were randomly allocated into one of three groups: willpower strengthening exercise intervention groups, 4-7-8 Hands or postural adjustments, or a control group. Participants assigned to the active intervention groups were required to practice the relevant willpower strengthening exercise every hour, for six hours per day, over three days. The high participation and compliance rates of participants in the two active intervention groups, along with positive feedback, supported the feasibility of the willpower strengthening exercises with university students. Additionally, the 4-7-8 Hands and posture groups reported directional improvements in willpower compared to the control group. Future research is recommended to evaluate the efficacy of willpower strengthening exercises over a longer time period to allow for more practice and effect time.

Improving sleep hygiene behavior in adults living with HIV/AIDS: a randomized control pilot study of the SystemCHANGETM–HIV intervention

AimThe aim of this study was to test the feasibility of a novel, evidence-based intervention SystemCHANGE–HIV on sleep outcomes. BackgroundInsomnia and sleep disturbances affect an estimated 74% of people living with HIV (PLWH) and is a distressing consequence of HIV disease. MethodsWe conducted a two-group randomized control study with 40 PLWH. Outcomes included change in: sleep duration, sleep fragmentation index, sleep efficiency, and self-reported sleep quality. ResultsParticipants rated the intervention as highly feasible. The intervention group experienced a 10minute/night increase in sleep time, a 2.3%-point increase in sleep efficiency, a 2.0%-point decrease in sleep fragmentation, relative to the control group, based on the model estimates of the treatment effect. ConclusionsA behavioral change intervention focusing on sleep is feasible in PLWH. The intervention group had improved sleep compared to the control group. Future work should test the efficacy of a refined SystemCHANGE–HIV on sleep.

TextTB: A parallel design randomized control pilot study to evaluate acceptance and feasibility of a patient-driven mobile phone based intervention to support adherence to TB treatment

TextTB: A parallel design randomized control pilot study to evaluate acceptance and feasibility of a patient-driven mobile phone based intervention to support adherence to TB treatment

112 A Pilot Study Investigating the Use of Heated Humidified Oxygen and Dry Oxygen Therapy in Children with Acute Respiratory Illness

Background and aimsLow flow oxygen can be delivered either as a dry or heated humidified gas. Little evidence exists about which is most beneficial to the paediatric patient. The aim...

Psychogenic Nonepileptic Seizures: A Pilot Study of a Brief Educational Intervention

Attending to psychological support and education from the time of diagnosis will assist patients in their acceptance of the need for psychological services. An intervention was provided at the time of diagnosis of psychogenic nonepileptic seizures. This randomized control pilot study examined outcomes 6-8 weeks after discharge from the hospital. All subjects in the treatment group made and/or kept an appointment with a psychotherapist or psychiatrist within 6-8 weeks of discharge from the hospital as compared with 50% of the control group. This supportive approach assists patients to accept the functional or nonorganic nature of their symptoms and the need for psychological services.

“Effect of pranayama and meditation as an add-on therapy in rehabilitation of patients with Guillain-Barré syndrome—a randomized control pilot study”

Objective: To study the add-on effects of pranayama and meditation in rehabilitation of patients with Guillain-Barré syndrome (GBS). Patients and Method: This randomized control pilot study was conducted in neurological rehabilitation unit of university tertiary research hospital. Twenty-two GBS patients, who consented for the study and satisfied selection criteria, were randomly assigned to yoga and control groups. Ten patients in each group completed the study. The yoga group received 15 sessions in total over a period of 3 weeks (1 h/session), one session per day on 5 days per week that consisted of relaxation, Pranayama (breathing practices) and Guided meditation in addition to conventional rehabilitation therapeutics. The control group received usual rehabilitation care. All the patients were assessed using Pittsburgh Sleep Quality Index, Numeric pain rating scale, Hospital anxiety and Depression scale and Barthel index score. Mann–Whitney U test and Wilcoxon’s signed rank test were used for statistical analysis. Results: Quality of sleep improved significantly with reduction of PSQI score in the yoga group (p = 0.04). There was reduction of pain scores, anxiety and depression in both the groups without statistical significance between groups (pain p > 0.05, anxiety p > 0.05 and depression p > 0.05). Overall functional status improved in both groups without significant difference (p > 0.05). Conclusions: Significant improvement was observed in quality of sleep with yogic relaxation, pranayama, and meditation in GBS patients.Implications for RehabilitationGBS is an inflammatory demyelinating polyneuro radiculopathy with multiple complications requiring long term care.Yoga and other rehabilitation measures contribute in improving functional abilities, pain and sleep quality in GBS patients.This randomized control trial showed that short term yoga practice can improve the quality of sleep as compare to other rehabilitation measures in GBS patients

CS04-04 - Avoiding specific foods may reduce adhd: should we change our prescriptions?

The effects of a restricted elimination diet (RED) on Attention Deficit Hyperactivity Disorder (ADHD) have been investigated in eight randomised controlled studies, five of which used a double-blind placebo controlled (DBPC) design (see table 1). The first and the eighth RED trial (the Impact of Nutrition on Children with ADHD (INCA) study), have been published in The Lancet. The RED studies provide convincing evidence for a statistically significant and clinically relevant effect of an RED on ADHD and on comorbid ODD, with an overall effect size on ADHD of 1.2 (see table 2). The INCA study has shown that sixty percent of a heterogeneous group of children with ADHD and ODD do not meet the ADHD and ODD criteria anymore following the RED, showing normal behaviour according to parents’, teacher's and blinded paediatrician's measurements (see figure 1 and figure 2). The results of the DBPC RED studies indicate that the beneficial effects of an RED on the behaviour of children with ADHD are not moderated by parental expectations. In addition, a recent randomised controlled pilot study investigating the effects of an RED on family structure and environment has shown that an RED does not seem to affect family structure or family environment in families motivated to enter RED research. It may be obvious that a restricted diet, commensurable to behavioural therapy, is very difficult to blind. Consequently, in order to conceal the treatment conditions in the DBPC studies, some dietary sacrifices had to be made to secure the blinding, obviously resulting in lower effect sizes than in open studies using an optimally restricted diet (see table 2). Considering that 1) the long-term effects of medication, the current therapy of ADHD, are disappointing; 2) 50% of children discontinue their medication within a two-year period; and 3) children with comorbid ODD have a worse prognosis, interventions that may prevent ADHD and ODD have great clinical potential. Children with ADHD responding favourably to a 5-week RED may be diagnosed Food-Induced ADHD (FI-ADHD); in these children ADHD may be considered a hypersensitivity disorder triggered by food (see figure 3). Children diagnosed FI-ADHD are advised to enter an RED challenge period to identify the incriminated foods, eventually resulting in a diet as elaborate as possible. Children with ADHD not responding favourably to an RED may be diagnosed Classic ADHD (C-ADHD) and may start treatment as usual. Further investigation is necessary to define the mechanism of food in children with FI-ADHD and the long-term effects of an RED. Taking the impressive results of all RED studies into account, a paradigm shift concerning diagnosis and treatment of ADHD is needed, and implementation of RED research in children with parents motivated to follow a 5 week RED is warranted.