A Randomized Controlled Trial Evaluating a Pain Training for Respite Workers Supporting Children With Disabilities Part Two: Training Evaluations and the Impact of Training on Knowledge Application

Abstract Within a parallel-group randomized control trial, pain training's impact on Respite Workers' (RW) care approaches and training evaluations was explored. RW (n = 158) from 14 organizations received pain or control training following randomization. Researchers were blind until randomization; allocations were not shared explicitly with organizations/participants. Participants completed a strategy use questionnaire immediately before and an evaluation immediately after training completion. Four-to-6 weeks later, participants completed the strategy use questionnaire and semistructured focus groups. No differences in pain approaches were noted in strategy use questionnaires. Per focus groups, both groups acquired a “knowing” about pain and applied pain-related care approaches in similarly. Pain training participants identified need for “growing and strengthening” pain knowledge. Training endorsements were favorable. RW pain training has value and may impact practice.

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A Randomised Controlled Trial of Pharmacist Medication Histories and Supplementary Prescribing on Medication Errors in Postoperative Medications

Anaesthesia and Intensive Care ◽

10.1177/0310057x1103900613 ◽

2011 ◽

Vol 39 (6) ◽

pp. 1064-1070 ◽

Cited By ~ 30

Author(s):

S. B. Marotti ◽

R. K. Kerridge ◽

M. D. Grimer

Keyword(s):

Hospital Stay ◽

Controlled Trial ◽

Control Group ◽

History Taking ◽

Medication History ◽

Parallel Group ◽

Supplementary Prescribing ◽

Randomised Controlled ◽

The Impact ◽

Parallel Group Trial

Errors in the management of regular medications at the time of hospital admission are common. This randomised controlled three-arm parallel-group trial examined the impact of pharmacist medication history taking and pharmacist supplementary prescribing on unintentional omissions of postoperative medications in a large perioperative service. Participants included elective surgical patients taking regular medications with a postoperative hospital stay of one night or more. Patients were randomly assigned, on admission, to usual care (n=120), a pharmacist medication history only (n=120) or pharmacist medication history and supplementary prescribing (n=120). A medication history involved the pharmacist interviewing the patient preoperatively and documenting a medication history in the medical record. In the supplementary prescribing group the patients’ regular medicines were also prescribed on the inpatient medication chart by the pharmacist, so that dosing could proceed as soon as possible after surgery without the need to wait for medical review. The estimate marginal mean number of missed doses during a patients hospital stay was 1.07 in the pharmacist supplementary prescribing group, which was significantly less than both the pharmacist history group (3.30) and the control group (3.21) (P <0.001). The number of medications charted at an incorrect dose or frequency was significantly reduced in the pharmacist history group and further reduced in the prescribing group (P <0.001). We conclude that many patients miss doses of regular medication during their hospital stay and preoperative medication history taking and supplementary prescribing by a pharmacist can reduce this.

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The Effect of DHA Supplementation on Cognition in Patients with Bipolar Disorder: An Exploratory Randomized Control Trial

Nutrients ◽

10.3390/nu12030708 ◽

2020 ◽

Vol 12 (3) ◽

pp. 708

Author(s):

Valentina Ciappolino ◽

Giuseppe DelVecchio ◽

Cecilia Prunas ◽

Angela Andreella ◽

Livio Finos ◽

...

Keyword(s):

Bipolar Disorder ◽

Corn Oil ◽

Controlled Trial ◽

Group Differences ◽

Double Blind ◽

Significant Group ◽

Brief Assessment ◽

Wide Range ◽

Randomized Control ◽

The Impact

Bipolar disorder (BD) is a severe mental disorder with a wide range of cognitive deficits, both in the euthymic and acute phase of the disease. Interestingly, in recent years, there has been a growing interest in investigating the impact of ω-3 polyunsaturated fatty acids on cognition in BD. In this context, the aim of this study is to evaluate the effect of docosahexaenoic acid (C22:6 ω-3, DHA) supplementation on cognitive performances in euthymic BD patients. This is an exploratory, single-centre, double-blind randomized controlled trial evaluating 12 weeks DHA supplementation (1250 mg daily) vs. a placebo (corn oil) in 31 euthymic BD patients compared to 15 healthy controls (HCs) on cognitive functions, assessed by the Brief Assessment of Cognition in Affective Disorder (BAC-A). Plasma levels of DHA were measured. After 12 weeks of treatment, no significant group differences were observed in all neuropsychological tests between the four groups, except for the emotion inhibition test, where HCs with DHA had higher scores compared to either BD with DHA (z = 3.9, p = 0.003) or BD with placebo (t = 3.7, p = 0.005). Although our results showed that DHA could be effective for ameliorating cognition in healthy subjects, future studies are still needed to clarify the impact of DHA on cognition in BD.

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Cigarette pack size and consumption: an adaptive randomised controlled trial

BMC Public Health ◽

10.1186/s12889-021-11413-4 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Ilse Lee ◽

Anna K. M. Blackwell ◽

Michelle Scollo ◽

Katie De-loyde ◽

Richard W. Morris ◽

...

Keyword(s):

Experimental Evidence ◽

Primary Outcome ◽

Controlled Trial ◽

Pack Size ◽

Sufficient Power ◽

Cigarette Pack ◽

Parallel Group ◽

Randomised Controlled ◽

The Impact ◽

Cigarette Packs

Abstract Background Observational evidence suggests that cigarette pack size – the number of cigarettes in a single pack – is associated with consumption but experimental evidence of a causal relationship is lacking. The tobacco industry is introducing increasingly large packs, in the absence of maximum cigarette pack size regulation. In Australia, the minimum pack size is 20 but packs of up to 50 cigarettes are available. We aimed to estimate the impact on smoking of reducing cigarette pack sizes from ≥25 to 20 cigarettes per pack. Method A two-stage adaptive parallel group RCT in which Australian smokers who usually purchase packs containing ≥25 cigarettes were randomised to use only packs containing either 20 (intervention) or their usual packs (control) for four weeks. The primary outcome, the average number of cigarettes smoked per day, was measured through collecting all finished cigarette packs, labelled with the number of cigarettes participants smoked. An interim sample size re-estimation was used to evaluate the possibility of detecting a meaningful difference in the primary outcome. Results The interim analysis, conducted when 124 participants had been randomised, suggested 1122 additional participants needed to be randomised for sufficient power to detect a meaningful effect. This exceeded pre-specified criteria for feasible recruitment, and data collection was terminated accordingly. Analysis of complete data (n = 79) indicated that the mean cigarettes smoked per day was 15.9 (SD = 8.5) in the intervention arm and 16.8 (SD = 6.7) among controls (difference − 0.9: 95%CI = − 4.3, 2.6). Conclusion It remains unclear whether reducing cigarette pack sizes from ≥25 to 20 cigarettes reduces cigarette consumption. Importantly, the results of this study provide no evidence that capping cigarette pack sizes would be ineffective at reducing smoking. The limitations identified in this study can inform a more efficient RCT, which is urgently required to address the dearth of experimental evidence on the impact of large cigarette pack sizes on smoking. Trial registration 10.1186/ISRCTN34202533

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A Randomized Controlled Trial Evaluating a Pain Assessment and Management Program for Respite Workers Supporting Children With Disabilities Part One: Pain-Related Knowledge and Perceptions

American Journal on Intellectual and Developmental Disabilities ◽

10.1352/1944-7558-126.4.271 ◽

2021 ◽

Vol 126 (4) ◽

pp. 271-288 ◽

Cited By ~ 1

Author(s):

Lara M. Genik ◽

Elisabeth L. Aerts ◽

Paula C. Barata ◽

Chantel C. Barney ◽

Stephen P. Lewis ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Pain Assessment ◽

Controlled Trial ◽

Management Program ◽

Control Group ◽

Intention To Treat ◽

Randomized Controlled ◽

Parallel Group ◽

Pain Knowledge

Abstract This parallel group randomized controlled trial tested effectiveness of the Let's Talk About Pain training on respite workers' (RW) pain-related knowledge and feasibility-confidence-skill ratings using between-group and within-group analyses. Fourteen children's respite organizations were randomized to pain or control training. Participants (nintervention = 66; ncontrol = 92) underwent a 3–3.5 hour training and completed measures at pre-, post-, and 4–6 week follow-up. Intention-to-treat (nintervention = 65; ncontrol = 92) and per-protocol (nintervention = 26–38; ncontrol = 40–57) analyses were conducted. Pain training participants demonstrated significantly higher pain knowledge and feasibility-confidence-skill ratings post-follow-up versus control group and significant increases in knowledge from pre-post. Significant gains were maintained from post-follow-up. Results represent a promising step towards enhancing pain-related care for children with IDD.

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Evaluation of the online-based self-help programme “Selfapy” in patients with unipolar depression: study protocol for a randomized, blinded parallel group dismantling study

10.21203/rs.3.rs-26062/v1 ◽

2020 ◽

Author(s):

Krämer Rico ◽

Stephan Köhler

Keyword(s):

Controlled Trial ◽

Depression Scale ◽

Unipolar Depression ◽

Drop Out ◽

Control Group ◽

Hamilton Depression Scale ◽

Self Help ◽

Parallel Group ◽

Blinded Study ◽

The Impact

Abstract Background: This study aims to evaluate the online-based self-help programme “Selfapy” on a sample of depressive subjects and, furthermore, the impact of an unaccompanied version vs. a therapeutic accompanied version. Subjects are randomly assigned to the unaccompanied course (without weekly calls from a psychologist), an accompanied course (with weekly calls from a psychologist), or the control group. Various secondary parameters related to online self-help programmes, such as life satisfaction, therapeutic relationship, social activation, self-esteem, attitude towards Internet interventions and drop-out rates, are also recorded.Methods: A sample size of 400 subjects will be included. Subjects must have at least a mild to moderate depressive episode (BDI-II and Hamilton Depression Scale) and then will be randomly assigned into one of three groups: (a) immediate access to the unaccompanied depression course of “Selfapy”, (b) immediate access to the accompanied depression course of “Selfapy”, or (c) access to “Selfapy” after a 24-week delay (waiting list). The intervention period will last for a period of 12 weeks. Diagnostic assessments will take place at four different points in time: T1 (at baseline before the treatment), T2 (6 weeks after the start of the intervention), T3 (12 weeks after the start of the intervention; end of program) and T4 (3 months after completion of the treatment follow-up).Conclusion: The effectiveness of the online self-help program "Selfapy" for depression, is to be investigated in a randomized, controlled, blinded study. Additionally, this study will utilize a “dismantled” approach to enable the comparison of the accompanied andTrial registration: Current Controlled Trial DRKS00017191Date of registration: 14.06.2019

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Cognitive Training Deep Dive: The Impact of Child, Training Behavior and Environmental Factors within a Controlled Trial of Cogmed for Fragile X Syndrome

Brain Sciences ◽

10.3390/brainsci10100671 ◽

2020 ◽

Vol 10 (10) ◽

pp. 671

Author(s):

Haleigh Scott ◽

Danielle J. Harvey ◽

Yueju Li ◽

Yingratana A. McLennan ◽

Cindy K. Johnston ◽

...

Keyword(s):

Fragile X Syndrome ◽

Cognitive Training ◽

Fragile X ◽

Controlled Trial ◽

Cognitive Intervention ◽

Quality Metrics ◽

Deep Dive ◽

Training Quality ◽

The Impact ◽

And Training

Children with fragile X syndrome (FXS) exhibit deficits in a variety of cognitive processes within the executive function domain. As working memory (WM) is known to support a wide range of cognitive, learning and adaptive functions, WM computer-based training programs have the potential to benefit people with FXS and other forms of intellectual and developmental disability (IDD). However, research on the effectiveness of WM training has been mixed. The current study is a follow-up “deep dive” into the data collected during a randomized controlled trial of Cogmed (Stockholm, Sweden) WM training in children with FXS. Analyses characterized the training data, identified training quality metrics, and identified subgroups of participants with similar training patterns. Child, parent, home environment and training quality metrics were explored in relation to the clinical outcomes during the WM training intervention. Baseline cognitive level and training behavior metrics were linked to gains in WM performance-based assessments and also to reductions in inattention and other behaviors related to executive functioning during the intervention. The results also support a recommendation that future cognitive intervention trials with individuals with IDD such as FXS include additional screening of participants to determine not only baseline feasibility, but also capacity for training progress over a short period prior to inclusion and randomization. This practice may also better identify individuals with IDD who are more likely to benefit from cognitive training in clinical and educational settings.

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Cigarette pack size and consumption: an adaptive randomised controlled trial

10.31234/osf.io/hty5p ◽

2021 ◽

Author(s):

Ilse Lee ◽

Anna Katherine Mary Blackwell ◽

Michelle Scollo ◽

Katie De-loyde ◽

Richard Morris ◽

...

Keyword(s):

Experimental Evidence ◽

Primary Outcome ◽

Controlled Trial ◽

Pack Size ◽

Sufficient Power ◽

Cigarette Pack ◽

Parallel Group ◽

Randomised Controlled ◽

The Impact ◽

Cigarette Packs

BackgroundObservational evidence suggests that cigarette pack size – the number of cigarettes in a single pack – is associated with consumption but experimental evidence of a causal relationship is lacking. The tobacco industry is introducing increasingly large packs, in the absence of maximum cigarette pack size regulation. In Australia, the minimum pack size is 20 but packs of up to 50 cigarettes are available. We aimed to estimate the impact on smoking of reducing cigarette pack sizes from ≥25 to 20 cigarettes per pack.Method A two-stage adaptive parallel group RCT in which Australian smokers who usually purchase packs containing ≥25 cigarettes were randomised to use only packs containing either 20 (intervention) or their usual packs (control) for four weeks. The primary outcome, the average number of cigarettes smoked per day, was measured through collecting all finished cigarette packs, labelled with the number of cigarettes participants smoked. An interim sample size re-estimation was used to evaluate the possibility of detecting a meaningful difference in the primary outcome. ResultsThe interim analysis, conducted when 124 participants had been randomised, suggested 1122 additional participants needed to be randomised for sufficient power to detect a meaningful effect. This exceeded pre-specified criteria for feasible recruitment, and data collection was terminated accordingly. Analysis of complete data (n=79) indicated that the mean cigarettes smoked per day was 15.9 (SD=8.5) in the intervention arm and 16.8 (SD=6.7) among controls (difference -0.9: 95%CI = -4.3, 2.6). ConclusionIt remains unclear whether reducing cigarette pack sizes from ≥25 to 20 cigarettes reduces cigarette consumption. The limitations identified in this study can inform a more efficient RCT, which is urgently required to address the dearth of experimental evidence on the impact of large cigarette pack sizes on smoking.

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Zinc Depletion Increases Readmission in Older Patients: An Example of Interactions Between Nutrition and Disease

International Journal for Vitamin and Nutrition Research ◽

10.1024/0300-9831/a000275 ◽

2017 ◽

Vol 87 (1-2) ◽

pp. 10-16 ◽

Cited By ~ 1

Author(s):

Salah Gariballa ◽

Awad Alessa

Keyword(s):

Nutritional Status ◽

Inductively Coupled Plasma ◽

Older Patients ◽

Controlled Trial ◽

Prognostic Indicators ◽

Hospitalised Patients ◽

Increased Risk ◽

Co Morbidity ◽

The Impact ◽

Poor Nutrition

Abstract. Background: ill health may lead to poor nutrition and poor nutrition to ill health, so identifying priorities for management still remains a challenge. The aim of this report is to present data on the impact of plasma zinc (Zn) depletion on important health outcomes after adjusting for other poor prognostic indicators in hospitalised patients. Methods: Hospitalised acutely ill older patients who were part of a large randomised controlled trial had their nutritional status assessed using anthropometric, hematological and biochemical data. Plasma Zn concentrations were measured at baseline, 6 weeks and at 6 months using inductively- coupled plasma spectroscopy method. Other clinical outcome measures of health were also measured. Results: A total of 345 patients assessed at baseline, 133 at 6 weeks and 163 at 6 months. At baseline 254 (74%) patients had a plasma Zn concentration below 10.71 μmol/L indicating biochemical depletion. The figures at 6 weeks and 6 months were 86 (65%) and 114 (70%) patients respectively. After adjusting for age, co-morbidity, nutritional status and tissue inflammation measured using CRP, only muscle mass and serum albumin showed significant and independent effects on plasma Zn concentrations. The risk of non-elective readmission in the 6-months follow up period was significantly lower in patients with normal Zn concentrations compared with those diagnosed with Zn depletion (adjusted hazard ratio 0.62 (95% CI: 0.38 to 0.99), p = 0.047. Conclusions: Zn depletion is common and associated with increased risk of readmission in acutely-ill older patients, however, the influence of underlying comorbidity on these results can not excluded.

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