scholarly journals Do clinical guidelines introduced with practice based education improve care of asthmatic and diabetic patients? A randomised controlled trial in general practices in east London

BMJ ◽  
1995 ◽  
Vol 311 (7018) ◽  
pp. 1473-1478 ◽  
Author(s):  
G. Feder ◽  
C. Griffiths ◽  
C. Highton ◽  
S. Eldridge ◽  
M. Spence ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Clinical Guidelines ◽  
Controlled Trial ◽  
Diabetic Patients ◽  
General Practices ◽  
Randomised Controlled

scholarly journals International Randomised Controlled Trial evaluating metabolic syndrome in type 2 Diabetic Cigarette Smokers following switching to Combustion-Free Nicotine Delivery Systems: the DIASMOKE protocol

2020 ◽  
Author(s):  
Arkadiusz Krysinski ◽  
Cristina Russo ◽  
Sarah John ◽  
Jonathan Belsey ◽  
Davide Campagna ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Health Impact ◽  
Diabetic Patients ◽  
Cigarette Smokers ◽  
Nicotine Delivery ◽  
Randomised Controlled ◽  
Type 2 Diabetic

Reducing exposure to cigarette smoke is an imperative for public health, and even more so for diabetic patients. Increasingly, combustion-free technologies for nicotine delivery such as e-cigarettes and heated tobacco products are substituting conventional cigarettes and accelerating the current downward trends in smoking prevalence. However, there is limited information about the long-term health impact in diabetics who use these technologies. This international randomised controlled trial of type 2 diabetic cigarette smokers will test the hypothesis that following a switch from conventional cigarettes to Combustion-Free Nicotine Delivery Systems (C-F NDS), a measurable improvement in metabolic syndrome (MetS) risk factors and functional parameters will be shown over the course of 2 years. A total of 576 patients will be randomized (1:2 ratio) to either a control arm (Study Arm A), in which they will be offered referral to smoking cessation programs or to an intervention arm (Study Arm B), in which they will be assigned to C-F NDS use. The primary outcome will be the prevalence of the a difference in MetS score between baseline and 2 years follow-up, with comparison being made between diabetic patients randomized to each arm of the study. Patient recruitment will start in October 2020 and enrolment is expected to be completed by August 2021. This will be the first study determining the overall health impact of using such technologies in diabetic patients. Data from this study will provide valuable insights into the overall potential of C-F NDS to reduce the risk of cardiovascular disease in individuals, particularly diabetic patients. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04231838

scholarly journals Acupuncture for cancer pain: protocol for a pilot pragmatic randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e025564
Author(s):  
Yihan He ◽  
Brian H May ◽  
Anthony Lin Zhang ◽  
Xinfeng Guo ◽  
Yihong Liu ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cancer Pain ◽  
Clinical Guidelines ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Control Group ◽  
Clinical Effects ◽  
Phone Calls ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

IntroductionAlthough acupuncture has been recommended for alleviating cancer pain by clinical guidelines, the level of the supporting evidence needs to be improved. A pragmatic randomised controlled trial (pRCT) in a hospital setting would provide real-world assessments of the overall clinical effects of acupuncture. This pilot trial aims to explore the feasibility and provide data for sample size calculations for a pRCT evaluating the effectiveness of acupuncture as an adjunctive therapy to routine medical care for cancer pain.Methods and analysisThirty patients with cancer admitted to the oncology department with moderate or severe pain will be recruited. Participants will be randomised at a ratio of 1:1 to the adjunctive acupuncture group or a control group which receives routine pain management without acupuncture. The standardised section of the acupuncture protocol will be developed based on the results of reviews of the literature, recommendations in clinical guidelines and interviews with clinical experts. The acupuncturist will be allowed to tailor the protocol according to the individual situation of each participant. Primary outcomes relevant to the feasibility of conducting a fully powered trial include: numbers and proportions of participants recruited, screened, consented and randomised; numbers and reasons for withdrawals and dropouts; numbers and types of adverse events; feasibility of implementing the trial procedures; evaluation of the comprehensiveness and ease-of-use of the case report form. Secondary outcomes are clinical measurements of the effectiveness of the treatment that are intended for use in the full-scale trial. Analysis of feasibility will be descriptive and pain intensity measures will be analysed using mixed-effects regression.Ethics and disseminationEthics approval was obtained from the Institutional Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (approval no: Z2017-184-01) and RMIT University Human Research Ethics Committee (reference no: 21361). Results will be disseminated in a peer-reviewed journal, and trial participants will be informed via email and/or phone calls.Trial registration numberChiCTR1800017023

scholarly journals Nephroprotective Impact of Adjuvant Yoga Therapy on Diabetes- A Randomised Controlled Trial

2020 ◽  
Author(s):  
Rajasekar Balaji ◽  
Meena Ramanathan ◽  
Ananda Balayogi Bhavanani
Keyword(s):  
Randomised Controlled Trial ◽  
Blood Sugar ◽  
Medical Management ◽  
Metabolic Diseases ◽  
Controlled Trial ◽  
Control Group ◽  
Diabetic Patients ◽  
Yoga Therapy ◽  
Yoga Group ◽  
Randomised Controlled

Introduction: Recent studies have provided abundant evidence about benefits of yoga in various chronic disorders. Diabetes Mellitus (DM) is a group of metabolic diseases characterised by chronic hyperglycaemia and renal complications of the disease are especially notable. It is estimated that 10% to 40% cases of Type 2 DM (T2DM) eventually end up having kidney failure. Yoga therapy may help to prevent progression of kidney damage in diabetic patients. Aim: To evaluate the effect of adjuvant yoga therapy on renal profile in diabetic patients. Materials and Methods: This single blind Randomised Controlled Trial (RCT) was designed as an interdisciplinary collaborative work between Centre for Yoga Therapy, Education and Research (CYTER) and Department of Endocrinology of Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth, Puducherry, India. A total of 72 diabetic patients with HbA1c, more than 7% were recruited and pre study evaluation of Fasting Blood Sugar (FBS), Postprandial Blood Sugar (PPBS), HbA1c, blood urea and serum creatinine were done. They were then randomised into control group (n=36) who received only standard medical management and yoga group (n=36) who received yoga therapy thrice weekly for 4 months along with standard medical management. Poststudy evaluation of all parameters was done at end of study period and data were analysed by Student’s paired and unpaired t-test for intra and intergroup comparisons. Results: Postinterventional comparisons revealed statistically significant reductions (p<0.001) in all glycaemic and renal parameters in the group receiving yoga therapy when compared with control group who didn’t receive the yoga intervention. Intragroup comparisons revealed significant reduction of all parameters in yoga group. Conclusion: It is concluded from the present RCT that yoga has a definite role as an adjuvant therapy as it enhances standard medical care and hence, can be recommended in routine clinical management of diabetes to prevent progression into complications that are part of the natural history of the disease.

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