The Effect of Glycomacropeptide versus Amino Acids on Phenylalanine and Tyrosine Variability over 24 Hours in Children with PKU: A Randomized Controlled Trial

Introduction: In phenylketonuria (PKU), evidence suggests that casein glycomacropeptide supplemented with rate-limiting amino acids (CGMP-AA) is associated with better protein utilisation and less blood phenylalanine (Phe) variability. Aim: To study the impact of CGMP-AA on blood Phe variability using 3 different dietary regimens in children with PKU. Methods: This was a 6-week randomised controlled cross-over study comparing CGMP-AA vs. Phe-free l-amino acids (l-AA) assessing blood Phe and tyrosine (Tyr) variability over 24 h in 19 children (7 boys) with PKU, with a median age of 10 years (6–16). Subjects were randomised to 3 dietary regimens: (1) R1, CGMP-AA and usual dietary Phe (CGMP + Phe); (2) R2, CGMP-AA − Phe content of CGMP-AA from usual diet (CGMP − Phe); and (3) R3, l-AA and usual dietary Phe. Each regimen was administered for 14 days. Over the last 48 h on days 13 and 14, blood spots were collected every 4 h at 08 h, 12 h, 16 h, 20 h, 24 h, and 04 h. Isocaloric intake and the same meal plan and protein substitute dosage at standardised times were maintained when blood spots were collected. Results: Eighteen children completed the study. Median Phe concentrations over 24 h for each group were (range) R1, 290 (30–580), R2, 220 (10–670), R3, 165 (10–640) μmol/L. R1 vs. R2 and R1 vs. R3 p < 0.0001; R2 vs. R3 p = 0.0009. There was a significant difference in median Phe at each time point between R1 vs. R2, p = 0.0027 and R1 vs. R3, p < 0.0001, but not between any time points for R2 vs. R3. Tyr was significantly higher in both R1 and R2 [70 (20–240 μmol/L] compared to R3 [60 (10–200) μmol/L]. In children < 12 years, blood Phe remained in the target range (120–360 μmol/L), over 24 h, for 75% of the time in R1, 72% in R2 and 64% in R3; for children aged ≥ 12 years, blood Phe was in target range (120–600 μmol/L) in R1 and R2 for 100% of the time, but 64% in R3. Conclusions: The residual Phe in CGMP-AA increased blood Phe concentration in children. CGMP-AA appears to give less blood Phe variability compared to l-AA, but this effect may be masked by the increased blood Phe concentrations associated with its Phe contribution. Reducing dietary Phe intake to compensate for CGMP-AA Phe content may help.

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SettleIN: Using a Manualised Intervention to Facilitate the Adjustment of Older Adults with Dementia Following Placement into Residential Care

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17072606 ◽

2020 ◽

Vol 17 (7) ◽

pp. 2606

Author(s):

Caroline A Saint-Bryant ◽

Judy Murrill ◽

Janine K Hayward ◽

Kayleigh-Marie Nunez ◽

Aimee Spector

Keyword(s):

Quality Of Life ◽

Residential Care ◽

Controlled Trial ◽

Care Home ◽

Post Intervention ◽

Significant Difference ◽

New Residents ◽

Randomised Controlled ◽

The Impact

The authors examined the feasibility of delivering an adapted version of SettleIN, a manualised staff-led programme designed to facilitate adjustment to care for new residents with dementia. The effects of SettleIN on resident adjustment, mood and quality of life were also investigated. A pilot randomised controlled trial was conducted. Nineteen new residents with dementia and 21 staff participants were recruited. Residents were randomly assigned to receive the SettleIN programme or residential care as usual. Resident quality of life, mood and overall adjustment were measured at baseline and post-intervention, in week seven. Interviews were conducted with staff in week seven to explore intervention feasibility. Despite medium to large effect sizes, there was no significant difference in mean change scores between the two conditions, with regards to quality of life, psychological wellbeing or overall adjustment outcomes. Qualitative feedback indicated that SettleIN was not feasible across all areas, with problems around recruitment and practicality. However, SettleIN was deemed feasible in terms of retention and acceptability among staff. The majority of staff felt that SettleIN was beneficial for residents but that organisational and programme factors impacted upon intervention feasibility. Further exploration of organisational barriers is needed in order to reduce the impact of such factors on care home research.

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Perioperative haemodynamic therapy for major gastrointestinal surgery: the effect of a Bayesian approach to interpreting the findings of a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2018-024256 ◽

2019 ◽

Vol 9 (3) ◽

pp. e024256 ◽

Cited By ~ 7

Author(s):

Elizabeth G Ryan ◽

Ewen M Harrison ◽

Rupert M Pearse ◽

Simon Gates

Keyword(s):

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Gastrointestinal Surgery ◽

Evidence Based ◽

Bayesian Analyses ◽

Therapy Algorithm ◽

Significant Difference ◽

Randomised Controlled ◽

The Impact

ObjectiveThe traditional approach of null hypothesis testing dominates the design and analysis of randomised controlled trials. This study aimed to demonstrate how a simple Bayesian analysis could have been used to analyse the Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome (OPTIMISE) trial to obtain more clinically interpretable results.Design, setting, participants and interventionsThe OPTIMISE trial was a pragmatic, multicentre, observer-blinded, randomised controlled trial of 734 high-risk patients undergoing major gastrointestinal surgery in 17 acute care hospitals in the UK. Patients were randomly allocated to a cardiac output-guided haemodynamic therapy algorithm for intravenous fluid and inotropic drug administration during and in the 6 hours following surgery (n=368) or to standard care (n=366). The primary outcome was a binary outcome consisting of a composite of predefined 30-day moderate or major complications and mortality.MethodsWe repeated the primary outcome analysis of the OPTIMISE trial using Bayesian statistical methods to calculate the probability that the intervention was superior, and the probability that a clinically relevant difference existed. We explored the impact of a flat prior and an evidence-based prior on our analyses.ResultsAlthough OPTIMISE was not powered to detect a statistically significant difference between the treatment arms for the observed effect size (relative risk=0.84, 95% CI 0.70 to 1.01; p=0.07), by using Bayesian analyses we were able to demonstrate that there was a 96.9% (flat prior) to 99.5% (evidence-based prior) probability that the intervention was superior to the control.ConclusionsThe use of a Bayesian analytical approach provided a different interpretation of the findings of the OPTIMISE trial (compared with the original frequentist analysis), and suggested patient benefit from the intervention. Incorporation of information from previous studies provided further evidence of a benefit from the intervention. Bayesian analyses can produce results that are more easily interpretable and relevant to clinicians and policy-makers.Trial registration numberISRCTN04386758; Post-results.

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Antibiotic prophylaxis in acute cholecystectomy revisited: results of a double-blind randomised controlled trial

Langenbeck s Archives of Surgery ◽

10.1007/s00423-020-01977-x ◽

2020 ◽

Vol 405 (8) ◽

pp. 1201-1207

Author(s):

Gona Jaafar ◽

Gabriel Sandblom ◽

Lars Lundell ◽

Folke Hammarqvist

Keyword(s):

Antibiotic Prophylaxis ◽

Acute Cholecystitis ◽

Controlled Trial ◽

Study Groups ◽

Double Blind ◽

Randomised Study ◽

Significant Difference ◽

Preoperative Antibiotic Prophylaxis ◽

Randomised Controlled ◽

The Impact

Abstract Purpose Evidence supporting the value of preoperative antibiotic prophylaxis (PAP) in surgery for acute cholecystitis is lacking. This study aimed to shed light on whether PAP in acute cholecystectomy for cholecystitis reduces the postoperative infectious complication (PIC) rate. Secondary outcomes were the prevalence of bacteriobilia, CRP values and leucocyte counts. Methods The study was performed as a single-centre, double-blinded, placebo-controlled, randomised study. Patients with acute cholecystitis amenable for acute laparoscopic cholecystectomy were randomly assigned to either PAP (piperacillin/ tazobactam) or placebo, and the subsequent clinical course was followed. Results A total of 106 patients were enrolled, 16 of whom were excluded due to protocol violation. PIC developed in 22 of the 90 patients included with no significant difference between the PAP and placebo groups (8 patients in the PAP group and 14 in the placebo arm, p = 0.193). The PIC rate was significantly higher in patients with a raised CRP at randomisation and on the day of surgery and in cases of conversion to an open procedure (p = 0.008, 0.004 and 0.017, respectively) but with no differences between the study groups. Conclusion PAP does not affect the risk for PIC in patients with acute cholecystitis. The major risk factors determining PIC in these patients need defining, in particular, the impact of bacteriobilia. Trial registration The study was registered at clinicaltrials.gov (NCT02619149) December 2, 2015.

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The impact of wearing an abdominal corset to achieve compression on colonoscopy outcomes: a randomised controlled trial

Gastrointestinal Nursing ◽

10.12968/gasn.2021.19.sup2.s18 ◽

2021 ◽

Vol 19 (Sup2) ◽

pp. S18-S23

Author(s):

Zeynep Kızılcık Özkan ◽

Ümmü Yıldız Fındık ◽

Doğan Albayrak

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

University Hospital ◽

Intubation Time ◽

Abdominal Compression ◽

Position Change ◽

Significant Difference ◽

Randomised Controlled ◽

The Impact ◽

Experimental Group

Aim: This study aimed to evaluate the effect of abdominal corset use on colonoscopy outcomes in patients undergoing colonoscopy. Methods: This randomised controlled trial was conducted between March 2019 and January 2020, with the participation of 60 patients who underwent colonoscopy in the endoscopy unit of a university hospital. Half (n=30) of these patients were included in the experimental group and wore an abdominal corset during colonoscopy. Findings: It was determined that there was no statistically significant difference between the groups according to variables, including caecal intubation time (p=0.371), the need for position change in the colonoscopy process (p=0.554), position change in caecum imaging (p=1.000) and manual abdominal compression during the procedure (p=0.091). Conclusions: The results of this study reveal that abdominal corset usage does not provide a significant extra benefit compared with conventional colonoscopy in improving colonoscopy outcomes.

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Corticosteroid Resistance in Smokers—A Substudy Analysis of the CORTICO-COP Randomised Controlled Trial

Journal of Clinical Medicine ◽

10.3390/jcm10122734 ◽

2021 ◽

Vol 10 (12) ◽

pp. 2734

Author(s):

Pradeesh Sivapalan ◽

Andras Bikov ◽

Charlotte Suppli Ulrik ◽

Therese Sophie Lapperre ◽

Alexander G. Mathioudakis ◽

...

Keyword(s):

Smoking Status ◽

Controlled Trial ◽

Standard Of Care ◽

Control Group ◽

Chronic Obstructive ◽

Obstructive Pulmonary Disease ◽

Corticosteroid Resistance ◽

Significant Difference ◽

Randomised Controlled ◽

The Impact

The CORTICO-COP trial showed that eosinophil-guided corticosteroid-sparing treatment for acute exacerbation of chronic obstructive pulmonary disease was non-inferior to standard of care and decreased the accumulated dose of systemic corticosteroids that patients were exposed to by approximately 60%. Smoking status has been shown to affect corticosteroid responsiveness. This post hoc analysis investigated whether eosinophil-guided treatment is non-inferior to conventional treatment in current smokers. The main analysis of current smokers showed no significant difference in the primary endpoint, days alive, and out of hospital within 14 days between the control group (mean, 9.8 days; 95% confidence interval (CI), 8.7–10.8) and the eosinophil-guided group (mean, 8.7 days; 95% CI, 7.5–9.9; p = 0.34). Secondary analyses of the number of exacerbations or deaths, the number of intensive care unit admissions or deaths, lung function improvement, and change in health-related quality of life also showed no significant differences between the two groups. The results of a sensitivity analysis of ex-smokers are consistent with the main analysis. Our results suggest that eosinophil-guided treatment is non-inferior to standard of care in current smokers and ex-smokers. Because data on the impact of smoking status on eosinophil-guided treatments are sparse, more randomised trials are needed to confirm our results.

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Impact of copper compression stockings on venous insufficiency and lipodermatosclerosis: A randomised controlled trial

Phlebology The Journal of Venous Disease ◽

10.1177/0268355518795329 ◽

2018 ◽

Vol 34 (4) ◽

pp. 224-230 ◽

Cited By ~ 2

Author(s):

Linda P Arendsen ◽

Stella Vig ◽

Ranee Thakar ◽

Abdul H Sultan

Keyword(s):

Surface Area ◽

Controlled Trial ◽

Chronic Venous Disease ◽

Control Group ◽

Venous Disease ◽

Compression Stocking ◽

Compression Stockings ◽

Significant Difference ◽

Randomised Controlled ◽

The Impact

Objective Compression stockings are the primary treatment for lipodermatosclerosis secondary to chronic venous disease, but do not improve the skin condition. The aim of this study was to investigate the impact of copper on lipodermatosclerosis. Methods A double-blind randomised controlled pilot study was performed including patients with bilateral lipodermatosclerosis. One compression stocking of a pair was impregnated with copper. Symptom score and surface area of lipodermatosclerosis were assessed at baseline, after 2, 4 and 8 weeks. Results Sixteen patients were included. There was no significant difference in mean symptom scores; however, there was a significant reduction of the surface area in the study group 42,637 to 35,739 mm2 versus 41,487 to 43,210 mm2 in the control group (p = 0.04). Conclusion This study demonstrates the beneficial effect of copper on lipodermatosclerosis secondary to chronic venous disease with reduction in surface area but no benefit on symptoms. Trials identification number: NCT03283800

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Reducing the Social Stigma Associated with Obsessive Compulsive Disorder: A Controlled Trial of an Intervention Program in a Turkish Community Sample

Journal of Evidence-Based Psychotherapies ◽

10.24193/jebp.2020.2.14 ◽

2020 ◽

Vol 20 (2) ◽

pp. 101-120

Author(s):

Ayça Aktaç Gürbüz ◽

Orçun YORULMAZ ◽

Gülşah DURNA

Keyword(s):

Obsessive Compulsive Disorder ◽

Intervention Program ◽

Controlled Trial ◽

Community Sample ◽

Case Vignette ◽

Control Group ◽

Obsessive Compulsive ◽

Compulsive Disorder ◽

Significant Difference ◽

The Impact

Scientific research into the reduction of stigmatization, particularly related to specific problems such as Obsessive-Compulsive Disorder (OCD), is scarce. In the present study, we examine the impact of a video-based antistigma intervention program for OCD in a pretest-posttest control group research. After being randomly assigned to either an intervention (n= 101) or control group (n= 96), the participants reported their attitudes on a hypothetical case vignette before and after OCD vs. Multiple Sclerosis (MS) videos, and again six months later as a follow up assessment. The mixed design analyses for the group comparisons indicated that although there was no significant difference in the measures of the control group, the participants watching the anti-stigma OCD video, in which the focus was psychoeducation and interaction strategies, reported significantly lower scores on social distances and negative beliefs for the case vignettes they read, and this difference was maintained six months later. Then, the present results indicate the effectiveness of our anti-stigma intervention program for OCD. Interventions to reduce stigmatization can also be viewed as effective tools for changing the attitudes of people toward OCD, although further research and applications are needed related to specific disorders if a longlasting impact is to be achieved.

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