A single blind randomised controlled trial of the impact on patient-reported pain of arm elevation versus exsanguination prior to tourniquet inflation

IntroductionPreserving residual kidney function (RKF) may be beneficial to patients on haemodialysis (HD) and it has been proposed that commencing dialysis incrementally rather than three times a week may preserve RKF. In Incremental HD, target dose includes a contribution from RKF, which is added to HD dose, allowing individualisation of the HD prescription. We will conduct a feasibility randomised controlled trial (RCT) comparing incremental HD and conventional three times weekly treatments in incident HD patients. The study is designed also to provide pilot data to allow determination of effect size to power a definitive study.Methods and analysisAfter screening to ensure native renal urea clearance >3 mL/min/1.73 m2, the study will randomise 54 patients within 3 months of HD initiation to conventional in-centre thrice weekly dialysis or incremental in-centre HD commencing 2 days a week. Subjects will be followed up for 12 months. The study will be carried out across four UK renal centres.The primary outcome is to evaluate the feasibility of conducting a definitive RCT and to estimate the difference in rate of decline of RKF between the two groups at 6 and 12 months time points. Secondary outcomes will include the impact of dialysis intensity on vascular access events, major adverse cardiac events and survival. Impact of dialysis intensity on patient-reported outcomes measures, cognition and frailty will be assessed using EQ-5D-5L, PHQ-9, Illness Intrusiveness Rating Score, Montreal Cognitive assessment and Clinical Frailty Score. Safety outcomes include hospitalisation, fluid overload episodes, hyperkalaemia events and vascular access events.This study will inform the design of a definitive study, adequately powered to determine whether RKF is better preserved after incremental HD initiation compared with conventional initiation.Ethics and disseminationEthics approval has been granted by Cambridge South Research Ethics Committee, United Kingdom(REC17/EE/0311). Results will be disseminated via peer-reviewed publication.Trial registration numberNCT03418181

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A single-blind clustered randomised controlled trial of daily record-keeping for reducing smoking tobacco expenditure among adult male household heads in rural Bangladesh

The Journal of Smoking Cessation ◽

10.1017/jsc.2020.12 ◽

2020 ◽

Vol 15 (2) ◽

pp. 76-83

Author(s):

Adnan M. S. Fakir ◽

Afraim Karim ◽

Mutasim Billah Mubde ◽

Mustahsin Aziz ◽

Azraf Uddin Ahmad

Keyword(s):

Randomised Controlled Trial ◽

Adult Male ◽

Controlled Trial ◽

Record Keeping ◽

Rural Bangladesh ◽

Household Heads ◽

Randomised Controlled ◽

And Control ◽

The Impact ◽

Single Blind

AbstractIntroductionThis study aims to assess the impact of a behavioural intervention, in the form of a self-monitoring record-keeping logbook, in reducing smoking tobacco expenditure amongst adult male household heads in rural Bangladesh.MethodThe experiment was designed as a single-blind clustered randomised controlled trial utilising two-stage random sampling. A total of 650 adult male household heads were sampled from 16 chars (riverine islands) from Gaibandha, Northern Bangladesh, with eight chars in treatment and control groups each, between November 2018 and January 2019. The intervention consisted of a logbook to record daily smoking tobacco intake for 4 weeks provided only to participants in treatment chars (n = 332) while households in control chars received nothing (n = 318).ResultsFinal analysis was conducted using 222 and 210 households in the treatment and control chars respectively. The logbook intervention had a significant impact (P-value = 0.040) on reducing daily tobacco expenditure by 14% (α = 95%; CI: −0.273, −0.008) for the treatment group relative to the control group based on a difference-in-difference estimator. This is equivalent to a reduction of 20 cigarettes or 140 bidis smoked in a month.ConclusionOur minimal contact intervention successfully induced a reduction in smoking tobacco expenditure, which could effectively be incorporated with existing programs in the char regions of Bangladesh.

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