scholarly journals COMPARATIVE EFFICACY OF QUININE AND ARTESUNATE IN THE TREATMENT OF SEVERE MALARIA IN CHILDREN: A RANDOMISED CONTROLLED TRIAL IN A TERTIARY HOSPITAL OF NORTH EAST INDIA

2019 ◽  
Vol 6 (37) ◽  
pp. 2523-2527
Author(s):  
Sujit Kumar Chakrabarti ◽  
Tapash Ghosh ◽  
Sanjib Kumar Debbarm
Keyword(s):  
Randomised Controlled Trial ◽  
Severe Malaria ◽  
Controlled Trial ◽  
Tertiary Hospital ◽  
Comparative Efficacy ◽  
North East India ◽  
North East ◽  
Randomised Controlled

scholarly journals Effect of an intensive patient educational programme on the quality of bowel preparation for colonoscopy: a single-blind randomised controlled trial

2020 ◽  
Vol 7 (1) ◽  
pp. e000376
Author(s):  
Sivakami Janahiraman ◽  
Chan Yen Tay ◽  
Jie Min Lee ◽  
Wen Ling Lim ◽  
Chun Hoe Khiew ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Bowel Preparation ◽  
Controlled Trial ◽  
Tertiary Hospital ◽  
Educational Programme ◽  
Control Group ◽  
Randomised Controlled ◽  
The Impact ◽  
Experimental Group

ObjectivePreprocedural bowel preparation is necessary for optimal colonoscopy visualisation. However, it is challenging to achieve high-quality bowel preparation among patients scheduled for colonoscopy. This study aims to evaluate the impact of an intensive patient educational programme on the quality of bowel preparation.DesignAn accessor-blinded randomised controlled trial was carried out at the outpatient surgical clinic of a tertiary hospital. Patients were randomly assigned to the control group (received standard written and verbal instructions) or the experimental group (received an intensive and structured educational programme). All subjects completed a questionnaire before colonoscopy to assess their compliance, acceptability, and tolerability towards bowel preparation regime. Quality of bowel preparation was determined using the Boston Bowel Preparation Scale (BBPS).ResultsA total of 300 subjects who fulfilled the inclusion criteria were recruited. The experimental group had a significantly higher proportion of good quality bowel preparation than the control group (98.7% vs 52.3%, p<0.001). The median total BBPS score was also significantly higher in the experimental group (8 vs 5, p<0.001). Factors associated with good quality of bowel preparation included educational programme (OR: 22.79, 95% CI: 4.23 to 122.85, p<0.001), compliance to bowel cleansing agent (OR: 24.98, 95% CI 3.12 to 199.71, p<0.001), very difficult acceptability of preparation (OR: 0.11, 95% CI 0.03 to 0.38, p<0.001), tolerability towards bowel preparation (OR: 4.98, 95% CI 1.44 to 17.20, p<0.011) and hypomotility drugs (OR: 3.03, 95% CI 0.12 to 0.91, p<0.05).ConclusionAn intensive patient educational programme can significantly improve the quality of bowel preparation for colonoscopy.

scholarly journals Acceptability and feasibility pilot randomised controlled trial of medical skin camouflage for recovery of women prisoners with self-harm scarring (COVER): the study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e021891
Author(s):  
Heather Mitchell ◽  
Kathryn M Abel ◽  
Brendan James Dunlop ◽  
Tammi Walker ◽  
Sandeep Ranote ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Self Esteem ◽  
Health Concern ◽  
Women Prisoners ◽  
Pilot Randomised Controlled Trial ◽  
North East ◽  
Self Harm ◽  
Randomised Controlled

IntroductionSelf-harm in prison is a major public health concern. Less than 5% of UK prisoners are women, but they carry out more than a fifth of prison self-harm. Scars resulting from self-harm can be traumatising and stigmatising, yet there has been little focus on recovery of women prisoners with self-harm scarring. Medical skin camouflage (MSC) clinics treat individuals with disfiguring skin conditions, with evidence of improved well-being, self-esteem and social interactions. Only one community study has piloted the use of MSC for self-harm scarring.Methods and analysisWe describe an acceptability and feasibility pilot randomised controlled trial; the first to examine MSC for women prisoners who self-harm. We aim to randomise 20–25 women prisoners to a 6-week MSC intervention and 20–25 to a waitlist control (to receive the MSC after the study period). We aim to train at least 6–10 long-term prisoners with personal experience of self-harm to deliver the intervention. Before and after intervention, we will pilot collection of women-centred outcomes, including quality of life, well-being and self-esteem. We will pilot collection of self-harm incidents during the intervention, resources used to manage/treat self-harm and follow-up of women at 12 weeks from baseline. Data on recruitment, retention and dropout will be recorded. We aim for the acceptability of the intervention to prison staff and women prisoners to be explored in qualitative interviews and focus groups.Ethics and disseminationEthical approval for COVER has been granted by the North East–York Research Ethics Committee (REC) for phases 1 and 2 (reference: 16/NE/0030) and West of Scotland REC 3 for phases 3 and 4 (reference: 16/WS/0155). Informed consent will be the primary consideration; it will be made clear that participation will have no effect on life in prison or eligibility for parole. Due to the nature of the study, disclosures of serious self-harm may need to be reported to prison officials. We aim for findings to be disseminated via events at the study prison, presentations at national/international conferences, journal publications, prison governor meetings and university/National Health Service trust communications.Trial registration numberNCT02638974; Pre-results.

scholarly journals EXercise to Prevent frailty and Loss Of independence in insulin treated older people with DiabetEs (EXPLODE): protocol for a feasibility randomised controlled trial (RCT)

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e048932
Author(s):  
Rachel Stocker ◽  
James Shaw ◽  
Guy S Taylor ◽  
Miles D Witham ◽  
Daniel J West
Keyword(s):  
Randomised Controlled Trial ◽  
Resistance Training ◽  
Resistance Exercise ◽  
Physical Function ◽  
Controlled Trial ◽  
Well Being ◽  
Training Programme ◽  
North East ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

IntroductionThere are 3.9 million people in the UK with diabetes. Sarcopenia, increased frailty and loss of independence are often unappreciated complications of diabetes. Resistance exercise shows promise in reducing these complications in older adult diabetes patients. The aim of this feasibility randomised controlled trial is to (1) characterise the physical function, cardiovascular health and the health and well-being of older adults with mild frailty with/without diabetes treated with insulin, (2) to understand the feasibility and acceptability of a 4-week resistance exercise training programme in improving these parameters for those with diabetes and (3) to test the feasibility of recruiting and randomising the diabetic participant group to a trial of resistance training.Methods and analysisThirty adults aged ≥60 years with insulin-treated diabetes mellitus (type 1 or 2), and 30 without, all with mild frailty (3–4 on the Rockwood Frailty Scale) will be recruited. All will complete blood, cardiovascular and physical function testing. Only the diabetic group will then proceed into the trial itself. They will be randomised 1:1 to a 4-week semisupervised resistance training programme, designed to increase muscle mass and strength, or to usual care, defined as their regular physical activity, for 4 weeks. This group will then repeat testing. Primary outcomes include recruitment rate, attrition rate, intervention fidelity and acceptability, and adherence to the training programme. A subset of participants will be interviewed before and after the training programme to understand experiences of resistance training, impact on health and living with diabetes (where relevant) as they have aged. Analyses will include descriptive statistics and qualitative thematic analysis.Ethics and disseminationThe North East-Newcastle and North Tyneside 2 Research Ethics Committee (20/NE/0178) approved the study. Outputs will include feasibility data to support funding applications for a future definitive trial, conference and patient and public involvement presentations, and peer-reviewed publications.Trial registration numberISRCTN13193281.

Immediate versus delayed insertion of the copper intrauterine device after medical abortion at 17–20 gestational weeks: a randomised controlled trial

2021 ◽  
pp. bmjsrh-2020-200932
Author(s):  
Deborah Constant ◽  
Margit Endler ◽  
Daniel Grossman ◽  
Gregory Petro ◽  
Malika Patel
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intrauterine Device ◽  
Medical Abortion ◽  
Tertiary Hospital ◽  
Community Healthcare ◽  
Intention To Treat ◽  
Randomised Controlled ◽  
Post Abortion ◽  
Copper Intrauterine Device

IntroductionThis trial reports on use of the copper intrauterine device (IUD) after immediate compared with delayed insertion following medical abortion at 17–20 gestational weeks (GW).MethodsThis randomised controlled trial was conducted at one tertiary hospital and five community healthcare centres in Cape Town, South Africa. Eligible consenting women were randomised to immediate (within 24 hours) or delayed (3 weeks post-abortion) insertion of the copper IUD. Follow-up was at 6 weeks, 3 months and 6 months. Main outcomes were use of the original IUD and use of any IUD, including replacement IUDs at 6 weeks post-abortion. Secondary outcomes included rates of expulsion and malposition at 6 weeks, use of any IUD at 3 and 6 months, and acceptability of the IUD.ResultsWe recruited and randomised 114 women admitted for elective medical abortion between August 2018 and June 2019. In the immediate and delayed study arms, respectively, 45/55 (82%) and 12/57 (21%) women received the IUD as planned. By intention-to-treat, 56% in the immediate and 19% in the delayed arms were using the original IUD at 6 weeks (p<0.001), and 76% in the immediate and 40% in the delayed arms were using any IUD (p<0.001). Complete expulsion or removal occurred in 32% in the immediate and 7% in the delayed arms (p=0.044).ConclusionsInsertion of an IUD immediately after medical abortion at 17–20 GW results in increased use after 6 weeks compared with delayed insertion, however expulsion rates are higher than with interval insertion.Clinical trials registrationNCT03505047), Pan African Trials Registry (www.pactr.org), 201804003324963

Direct swallowing training and oral sensorimotor stimulation in preterm infants: a randomised controlled trial

2021 ◽  
pp. fetalneonatal-2021-321945
Author(s):  
Ju Sun Heo ◽  
Ee-Kyung Kim ◽  
Sae Yun Kim ◽  
In Gyu Song ◽  
Young Mi Yoon ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Tube Feeding ◽  
Tertiary Hospital ◽  
Oral Feeding ◽  
Very Preterm Infants ◽  
Very Preterm ◽  
Randomised Controlled

ObjectiveTo evaluate the effects of direct swallowing training (DST) alone and combined with oral sensorimotor stimulation (OSMS) on oral feeding ability in very preterm infants.DesignBlinded, parallel group, randomised controlled trial (1:1:1).SettingNeonatal intensive care unit of a South Korean tertiary hospital.ParticipantsPreterm infants born at <32 weeks of gestation who achieved full tube feeding.InterventionsTwo sessions per day were provided according to the randomly assigned groups (control: two times per day sham intervention; DST: DST and sham interventions, each once a day; DST+OSMS: DST and OSMS interventions, each once a day).Primary outcomeTime from start to independent oral feeding (IOF).ResultsAnalyses were conducted in 186 participants based on modified intention-to-treat (63 control; 63 DST; 60 DST+OSMS). The mean time from start to IOF differed significantly between the control, DST and DST+OSMS groups (21.1, 17.2 and 14.8 days, respectively, p=0.02). Compared with non-intervention, DST+OSMS significantly shortened the time from start to IOF (effect size: −0.49; 95% CI: −0.86 to –0.14; p=0.02), whereas DST did not. The proportion of feeding volume taken during the initial 5 min, an index of infants’ actual feeding ability when fatigue is minimal, increased earlier in the DST+OSMS than in the DST.ConclusionsIn very preterm infants, DST+OSMS led to the accelerated attainment of IOF compared with non-intervention, whereas DST alone did not. The effect of DST+OSMS on oral feeding ability appeared earlier than that of DST alone.Trial registration numberClinicalTrials.gov Registry (NCT02508571).

scholarly journals Decreasing Hypothermia-Related Escalation of Care in Newborn Infants Using the BEMPU TempWatch: A Randomised Controlled Trial

Children ◽  
2021 ◽  
Vol 8 (11) ◽  
pp. 1068
Author(s):  
Donna Lei ◽  
Kenneth Tan ◽  
Atul Malhotra
Keyword(s):  
Randomised Controlled Trial ◽  
Exclusive Breastfeeding ◽  
Standard Care ◽  
Controlled Trial ◽  
Newborn Infants ◽  
Tertiary Hospital ◽  
Control Group ◽  
Initial Hospital ◽  
Randomised Controlled ◽  
To Receive

Objective: To determine whether incorporating BEMPU TempWatch into the care of LBW/SGA neonates for continuous temperature monitoring decreases the rate of hypothermia requiring escalation of care. Methods: This was a randomised controlled trial conducted in a tertiary hospital in Melbourne, Australia. Participants were late preterm and term LBW/SGA neonates on the postnatal wards. Neonates were randomly assigned to receive either the BEMPU TempWatch in addition to standard care, or to receive standard care alone for the first 28 days of life. The primary outcome was hypothermia requiring escalation of care during initial hospital stay after birth. Results: Trial was discontinued after planned interim feasibility analysis, due to very low rates of hypothermia requiring escalation of care. In total, 75 neonates were included, with 36 in the intervention (TempWatch) group and 39 in the control group. The rate of hypothermia requiring escalation of care was 2/36 (5.6%) in the TempWatch group and 1/39 (2.6%) in the control group (relative risk (RR) 2.17, 95% CI 0.21 to 22.89). Rates of exclusive breastfeeding at discharge were 22/36 (61.1%) in the TempWatch and 13/39 (33.3%) in the control group (RR 1.83, 95% CI 1.10 to 3.07, p = 0.02). All other secondary outcomes were similar between the groups. Conclusions: Low rates of hypothermia requiring escalation of care in a tertiary, high-income setting meant it was not feasible for studying the effects of the TempWatch for this outcome. TempWatch may have a role in promoting exclusive breastfeeding, and this needs to be explored further.

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