Randomised-controlled trial of ketamine augmentation of ECT on neuropsychological and clinical outcomes in depression (Ketamine-ECT Study)

2016 ◽  
Author(s):  
Ian Anderson
Keyword(s):  
Randomised Controlled Trial ◽  
Clinical Outcomes ◽  
Controlled Trial ◽  
Randomised Controlled

Longer-Term Clinical and Economic Benefits of Offering Acupuncture to Patients with Chronic Low Back Pain Assessed as Suitable for Primary Care Management – 3 Month Clinical Outcomes from a Controlled Trial of 241 Patients

2002 ◽  
Vol 20 (2-3) ◽  
pp. 121-137
Author(s):  
H Macpherson ◽  
K Thomas ◽  
J Brazier ◽  
M Fitter ◽  
L Thorpe ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Randomised Controlled Trial ◽  
Clinical Outcomes ◽  
Controlled Trial ◽  
Bodily Pain ◽  
Control Group ◽  
Low Back ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Objectives To undertake a pragmatic randomised controlled trial to test the hypothesis that a population of patients with persistent low back pain, when given access to an acupuncture service, gain more relief from pain than those offered usual management only, for equal or less cost. Methods The study is a pragmatic randomised controlled trial (n=241). Suitable patients are identified by their general practitioners. Patients randomised to the experimental arm are offered the option of referral for up to 10 individualised treatments from one of six qualified acupuncture practitioners. The control group continues to receive usual management from their general practitioner. The primary scale used for measuring change is the Bodily Pain (SF–36) at 3 months and 12 months post randomisation. The main outcome is cost-effectiveness at 12 months. Results A total of 43 general practitioners participated in the trial and 241 patients were randomised. All patients randomised to the option of acupuncture chose to receive treatment. Clinical outcomes at 3 months show that the SF-36 Bodily Pain scores improved by 29.4 and 24.9 points in the acupuncture and normal management group respectively (p=0.125). Patients in the acupuncture group reported lower levels of worry at three months (p<0.001). Conclusions It is possible to conduct a large pragmatic randomised controlled trial of acupuncture in a primary care setting. Acupuncture is seen as an acceptable treatment by patients with low back pain. Clinical outcomes at three months suggest that the acupuncture group are in less pain than the control group.

scholarly journals A Study to Inform the Design of a National Multicentre Randomised Controlled Trial to Evaluate If Reducing Serum Phosphate to Normal Levels Improves Clinical Outcomes including Mortality, Cardiovascular Events, Bone Pain, or Fracture in Patients on Dialysis

2015 ◽  
Vol 2015 ◽  
pp. 1-12 ◽  
Author(s):  
Ramya Bhargava ◽  
Philip A. Kalra ◽  
Paul Brenchley ◽  
Helen Hurst ◽  
Alastair Hutchison
Keyword(s):  
Randomised Controlled Trial ◽  
Clinical Outcomes ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Drop Out ◽  
Phosphate Binders ◽  
Dialysis Patients ◽  
Definitive Trial ◽  
Registration Number ◽  
Randomised Controlled

Background. Retrospective, observational studies link high phosphate with mortality in dialysis patients. This generates research hypotheses but does not establish “cause-and-effect.” A large randomised controlled trial (RCT) of about 3000 patients randomised 50 : 50 to lower or higher phosphate ranges is required to answer the key question: does reducing phosphate levels improve clinical outcomes? Whether such a trial is technically possible is unknown; therefore, a study is necessary to inform the design and conduct of a future, definitive trial.Methodology. Dual centre prospective parallel group study: 100 dialysis patients randomized to lower (phosphate target 0.8 to 1.4 mmol/L) or higher range group (1.8 to 2.4 mmol/L). Non-calcium-containing phosphate binders and questionnaires will be used to achieve target phosphate. Primary endpoint: percentage successfully titrated to required range and percentage maintained in these groups over the maintenance period. Secondary endpoints: consent rate, drop-out rates, and cardiovascular events.Discussion. This study will inform design of a large definitive trial of the effect of phosphate on mortality and cardiovascular events in dialysis patients. If phosphate lowering improves outcomes, we would be reassured of the validity of this clinical practice. If, on the other hand, there is no improvement, a reassessment of resource allocation to therapies proven to improve outcomes will result.Trial Registration Number. This trial is registered with ISRCTN registration numberISRCTN24741445.

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