Lessons from a pilot and feasibility randomised trial in depression (Blood pressure Rapid Intensive Lowering And Normal Treatment for Mood and cognition in persistent depression (BRILiANT mood study))

Olsen, Kirsty; Howel, Denise; Barber, Robert; Ford, Gary A.; Gallagher, Peter; McAllister-Williams, R. Hamish; Nilsson, Johanna; O’Brien, John; Parker, Jennie; Thomas, Alan

doi:10.1186/s40814-015-0042-y

“…However, because of better management of hypertension due to changes in the UK Quality and Outcomes Framework guidelines for blood pressure treatment, few eligible patients were identified and the study closed at the end of the recruitment period, with 13 participants consenting, but 12 failing screening resulting in one recruited participant [77]. ”…”

Section: Resultsmentioning

confidence: 99%

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Eldridge

¹

,

Chan

²

,

Campbell

³

et al. 2016

Pilot Feasibility Stud

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The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply.The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist.The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number.This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials.Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.Electronic supplementary materialThe online version of this article (doi:10.1186/s40814-016-0105-8) contains supplementary material, which is available to authorized users.

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“…“Recruitment rates were lower than expected which led to the study being expanded to further areas and opened to self-referral via advertisement. However, because of better management of hypertension due to changes in the UK Quality and Outcomes Framework guidelines for blood pressure treatment, few eligible patients were identified and the study closed at the end of the recruitment period, with 13 participants consenting, but 12 failing screening resulting in one recruited participant.” 77 …”

Section: Extension Of Consort 2010 To Pilot Trialsmentioning

confidence: 99%

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Eldridge

¹

,

Chan

²

,

Campbell

³

et al. 2016

BMJ

View full text Add to dashboard Cite

The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply.The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist.The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number.This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials.Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.

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“…[ 19 ] Previous depressive symptoms or major depressive disorders can predict a 2- to 3-fold increase in coronary heart disease and stroke disease. [ 20 ] Patients who had both hypertension and depression were associated with a higher mortality and higher risk of complications.…”

Section: Introductionmentioning

confidence: 99%

Predictive markers of depression in hypertension

Song

¹

,

Zhang

²

,

Zhang

³

et al. 2018

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Hypertension and depression, as 2 major public health issues, are closely related. For patients having hypertension, in particular, depression is a risk factor for mortality and jeopardizes their wellbeing. The aim of the study is to apply support vector machine (SVM) learning to blood tests and vital signs to classify patients having hypertension complicated by depression and patients having hypertension alone for the identification of novel markers.Data on patients having both hypertension and depression (n = 147) and patients having hypertension alone (n = 147) were obtained from electronic medical records of admissions containing the records on blood tests and vital signs. Using SVM, we distinguished patients having both hypertension and depression from gender- and age-matched patients having hypertension alone.SVM-based classification achieved 73.5% accuracy by 10-fold cross-validation between patients having both hypertension and depression and those having hypertension alone. Twelve features were selected to compose the optimal feature sets, including body temperature (T), glucose (GLU), creatine kinase (CK), albumin (ALB), hydroxybutyrate dehydrogenase (HBDH), blood urea nitrogen (BUN), uric Acid (UA), creatinine (Crea), cholesterol (TC), total protein (TP), pulse (P), and respiration (R).SVM can be used to distinguish patients having both hypertension and depression from those having hypertension alone. A significant association was identified between depression and blood tests and vital signs. This approach can be helpful for clinical diagnosis of depression, but further studies are needed to verify the role of these candidate markers for depression diagnosis.

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Lessons from a pilot and feasibility randomised trial in depression (Blood pressure Rapid Intensive Lowering And Normal Treatment for Mood and cognition in persistent depression (BRILiANT mood study))

Cited by 5 publications

References 38 publications

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Predictive markers of depression in hypertension

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