Clinical Trial

The impact of a bariatric rehabilitation service on weight loss and psychological adjustment - Study protocol

by Jane Ogden

An underpowered study with many biases and confounding factors might confuse more than clarify

by Joost Smolders

Luigi Grimaldi, Frederik Barkhof, Manolo Beelke, Jodie Burton, Trygve Holmoy, Raymond Hupperts, Joep Killestein, Peter Rieckmann, Miriam Schluep, Joost Smolders; on behalf of the SOLAR study group. Neurology 2012; 78(11): 840-841.

The Stein et al. conclusion that high-dose ineffective vs. low-dose vitamin D2 supplementation in relapsing-remitting... more The Stein et al. conclusion that high-dose ineffective vs. low-dose vitamin D2 supplementation in relapsing-remitting multiple sclerosis (RRMS) is not supported by data enabling level 1 evidence...

Tooth-size discrepancy and Bolton's ratios: the reproducibility and speed of two methods of measurement

by Siti Adibah Othman

OBJECTIVE: To determine and compare the reproducibility and speed of two methods of performing Bolton's tooth-size... more OBJECTIVE: To determine and compare the reproducibility and speed of two methods of performing Bolton's tooth-size analysis. DESIGN: Analysis of randomly selected clinical sample. SETTING: Bristol Dental Hospital, University of Bristol, United Kingdom. MATERIALS AND METHODS: Pre-treatment study casts of 150 patients were selected randomly from 1100 consecutively treated Caucasian orthodontic patients. Bolton tooth-size discrepancies and ratios were measured using two methods; one method employed entirely manual measurement and the Odontorule slide rule, while the other employed digital calipers and the HATS analysis software. Twenty study casts were measured twice, a week apart with both methods. Another three investigators also measured 20 study casts twice with the HATS analysis. RESULTS: There were small or no systematic errors within or between these two methods. A very significant difference was evident for mean time measurements between the two methods (mean time for HATS was 3.5 minutes and for Odontorule was 8.9 minutes). There was relatively high error variance of both methods of measurement as a percentage of the total variance. CONCLUSIONS: On-line electronic measurement was found to be more rapid than the manual method used. Both methods demonstrate relatively high random error and this has important consequences for the clinical use of Bolton's ratios.

Effect of self-administered auricular acupressure on smoking cessation --a pilot study. Leung, L. et al.

by Lawrence Leung

BMC Complementary and Alternative Medicine 2012, 12:11

Background
Tobacco smoking is still a worldwide health risk. Current pharmacotherapies have at best, a success... more Background
Tobacco smoking is still a worldwide health risk. Current pharmacotherapies have at best, a success rate of no more than 50%. Auricular (ear) acupressure has been purported to be beneficial in achieving smoking cessation in some studies, while in others has been deemed insignificant. We hereby describe the protocol for a three-arm randomised controlled trial to examine the possible benefits of self-administered acupressure for smoking cessation.

Methods
Sixty consenting participants with confirmed habit of tobacco smoking will be recruited and randomized into three arms to receive either auricular acupressure at five true acupoints (NADA protocol), auricular acupressure at five sham points, or no auricular acupressure at all. Participants having auricular acupressure will exert firm pressure to each acupoint bilaterally via the bead in the attached plasters whenever they feel the urge to smoke. The treatment phase will last for six weeks during which all participants will be assessed weekly to review their smoking log, state of abstinence, end-exhalation carbon monoxide levels and possible adverse effects including withdrawal reactions and stress levels. At any time, a successful quit date will be defined with continuous abstinence for the following consecutive 7 days. From then on, participants will be evaluated individually for continuous abstinence rate (CAR), end-exhalation carbon monoxide levels and adverse effects of stress and withdrawal at specified intervals up to 26 weeks. Expectancy of treatment will be assessed with a four-item Borkovec and Nau self-assessment credibility scale during and after intervention.

Discussion
We incorporate validated outcome measures of smoking cessation into our randomised controlled trial design with the objectives to evaluate the feasibility and possible benefits of self-administered auricular acupressure as a non-invasive alternative to pharmacotherapy for smoking cessation. Trial registration ClinicalTrials.gov registration identifier: NCT01389622 (registered Jul 7 2011)

Why do patients decline to take part in a research project involving pulmonary rehabilitation?

by Nicola Roberts

Emergence of norms for biomedical research. At the origin of the Huriet law (1975-1988)

by nicolas lechopier

First paper, in 2004

The French law for the Protection of persons involved in biomedical research, known as «Loi Huriet», defines the frame... more The French law for the Protection of persons involved in biomedical research, known as «Loi Huriet», defines the frame in which biomedical experimentations on human subjects can take place. Insisting on the emergent character of the norms (laws, scientific standards…) for clinical research in France, this paper presents the general context in which such a law was promulgated. It gives an historical focus on its principal dispositions and underlines the conceptual issues raised by the public acknowledgment of the existence of scientific investigations on humans. This paper contributes to the debate on the meaning of the main notions of the French normative system applying to biomedical researches (protection of the person, individual direct benefice…)

Intervention for homeless, substance abusing mothers: Findings from a non-randomized pilot.

by Gizem Erdem

Slesnick, N. & Erdem, G. (in press). Intervention for homeless, substance abusing mothers: Findings from a non-randomized pilot. Behavioral Medicine.

The utility of mentoring homeless youth: A pilot study.

by Gizem Erdem

Bartle-Haring, S., Slesnick, N., Collins, J., Erdem, G., & Buettner, C. (in press). The utility of mentoring homeless youth: A pilot study. American Journal of Drug and Alcohol Abuse.

Pharmacist intervention in primary care to improve outcomes in patients with left ventricular systolic dysfunction

by Frances Mair

This was a late breaking trial at the American Heart Association Mtg on 14 November 2011. It is the largest and longest  study of a pharmacist intervention for heart failure published to date. Co-authored with: Richard Lowrie, Nicola Greenlaw, Paul Forsyth, Pardeep S. Jhund, Alex McConnachie, Brian Rae and John J.V. McMurray.

Background Meta-analysis of small trials suggests that pharmacist-led collaborative review and revision of... more
Background Meta-analysis of small trials suggests that pharmacist-led collaborative review and revision of medical treatment may improve outcomes in heart failure.


Methods and results We studied patients with left ventricular systolic dysfunction in a cluster-randomized controlled, event driven, trial in primary care. We allocated 87 practices (1090 patients) to pharmacist intervention and 87 practices (1074 patients) to usual care. The intervention was delivered by non-specialist pharmacists working with family doctors to optimize medical treatment. The primary outcome was a composite of death or hospital admission for worsening heart failure. This trial is registered, number ISRCTN70118765. The median follow-up was 4.7 years. At baseline, 86% of patients in both groups were treated with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. In patients not receiving one or other of these medications, or receiving less than the recommended dose, treatment was started, or the dose increased, in 33.1% of patients in the intervention group and in 18.5% of the usual care group [odds ratio (OR) 2.26, 95% CI 1.64–3.10; P< 0.001]. At baseline, 62% of each group were treated with a β-blocker and the proportions starting or having an increase in the dose were 17.9% in the intervention group and 11.1% in the usual care group (OR 1.76, 95% CI 1.31–2.35; P< 0.001). The primary outcome occurred in 35.8% of patients in the intervention group and 35.4% in the usual care group (hazard ratio 0.97, 95% CI 0.83–1.14; P = 0.72). There was no difference in any secondary outcome.


Conclusion A low-intensity, pharmacist-led collaborative intervention in primary care resulted in modest improvements in prescribing of disease-modifying medications but did not improve clinical outcomes in a population that was relatively well treated at baseline.

RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ANETHUM, NICOTINIC ACID AND CLOFIBRATE IN PATIENTS WITH ISOLATED …

by Fariba Asghari

Medicalization Has Implications: Rethinking Antiretroviral Treatments in MSM-Targeted HIV-Prevention Efforts

by Ryan Whitacre

Winner of the Ronald Frankenberg Prize for Outstanding Honors Thesis in Critical Medical Anthropology, UC Berkeley.

Evidence for placebo effects on physical but not on biochemical outcome parameters: a review of clinical trials

by Karin Meissner

Meissner K, Distel H, Mitzdorf U.
BMC Med 2007;5:3.

Efficacy of vitamin D (3) as add-on therapy in patients with relapsing-remitting multiple sclerosis receiving subcutaneous interferon beta-1a: A Phase II, multicenter, …

by Joost Smolders

Joost Smolders, Raymond Hupperts, Frederik Barkhof, Luigi M.E. Grimaldi, Trygve Holmoy, Joep Killestein, Peter Rieckmann, Myriam Schluep, Reinhold Vieth, Ulrike Hostalek, Lizette Ghazi-Visser, Manolo Beelke, on behalf of the SOLAR study group. Journal of the Neurological Sciences 2011; 311(1-2): 44-49.

Recent studies have demonstrated the immunomodulatory properties of vitamin D, and vitamin D deficiency may be a risk... more Recent studies have demonstrated the immunomodulatory properties of vitamin D, and vitamin D deficiency may be a risk factor for the development of MS. The risk of developing MS has, in fact, been associated with rising latitudes, past exposure to sun and serum vitamin D status. Serum 25-hydroxyvitamin D [25(OH)D] levels have also been associated with relapses and disability progression. The identification of risk factors, such as vitamin D deficiency, in MS may provide an opportunity to improve current treatment strategies, through combination therapy with established MS treatments. Accordingly, vitamin D may play a role in MS therapy. Small clinical studies of vitamin D supplementation in patients with MS have reported positive immunomodulatory effects, reduced relapse rates and a reduction in the number of gadolinium-enhancing lesions. However, large randomized clinical trials of vitamin D supplementation in patients with MS are lacking.

SOLAR (Supplementation of VigantOL® oil versus placebo as Add-on in patients with relapsing–remitting multiple sclerosis receiving Rebif® treatment) is a 96-week, three-arm, multicenter, double-blind, randomized, placebo-controlled, Phase II trial (NCT01285401). SOLAR will evaluate the efficacy of vitamin D3 as add-on therapy to subcutaneous interferon beta-1a in patients with RRMS. Recruitment began in February 2011 and is aimed to take place over 1 calendar year due to the potential influence of seasonal differences in 25(OH)D levels.

Sponsored clinical trials and bias.

by Adrian Preda

Introduction to "Medicalization Has Implications: Rethinking Antiretroviral Treatments in MSM-Targeted HIV-Prevention Efforts"

by Ryan Whitacre

Winner of the Ronald Frankenberg Prize for outstanding honors thesis in critical medical anthropology, UC Berkeley, Department of Anthropology, 2011.

The handsearching of 2 medical journals of Bahrain for reports of randomized controlled trials.

by Zbys Fedorowicz

Assessment of the Methodological Quality of Reporting of Randomized Trials in Four Iranian Healthcare Journals

by Zbys Fedorowicz

A comparison of handsearching versus EMBASE searching of the Annals of Saudi Medicine to identify reports of randomized controlled trials.

by Zbys Fedorowicz

The Ottawa Statement. International registration of protocol information and results from human trials of health related interventions.

by Zbys Fedorowicz

What We Talk About When We Talk About Phase 0

by Dr Silvia Camporesi

The term 'Phase 0 trials' looks therefore like a big umbrella, covering maybe too many things: microdose studies,... more The term 'Phase 0 trials' looks therefore like a big umbrella, covering maybe too many things: microdose studies, functional imaging studies, and molecular proof of concept studies which briefly reach a pharmaceutical dose.

According to some commentators in Europe, the 'Phase 0 concept' is not new, and it has been incorporated as a pharmacokinetic or pharmacodynamic endpoint in Phase 1 clinical trials conducted well before the 2004 and 2006 guidelines. 4 However, retrospective talk of any kind needs to be taken cautiously. How can we say that something existed when we did not even have a name for it? The name is important, not a mere 'decoration': the role of guidelines is fundamental in shaping the way and creating a scientific and legal platform for these studies. The guidelines have practical implications, in that they require a lower amount of preclinical data for exploratory studies, which still depends on the kind of design, but is lower than traditional Phase 1 studies.1