Protocol for the ORaClES study: an online randomised controlled trial to improve clinical estimates of survival using a training resource for medical students

IntroductionClinicians often struggle to recognise when palliative care patients are imminently dying (last 72 hours of life). A previous study identified the factors that expert palliative care doctors (with demonstrated prognostic skills) had used, to form a judgement about which patients were imminently dying. This protocol describes a study to evaluate whether an online training resource showing how experts weighted the importance of various symptoms and signs can teach medical students to formulate survival estimates for palliative care patients that are more similar to the experts’ estimates.Methods and analysisThis online double-blind randomised controlled trial will recruit at least 128 students in the penultimate or final year of medical school in the UK. Participants are asked to review three series of vignettes describing patients referred to palliative care and provide an estimate about the probability (0%–100%) that each patient will die within 72 hours. After the first series, students randomised to the intervention arm are given access to an online training resource. All participants are asked to complete a second series of vignettes. After 2 weeks, all participants are asked to complete a third series. The primary outcome will be the probability of death estimates (0%–100%) provided by students in the intervention and control arms for the second series of vignettes. Secondary outcomes include the maintenance effect at 2-week follow-up, weighting of individual symptoms and signs, and level of expertise (discrimination and consistency).Ethics and disseminationApproval has been obtained from the UCL Research Ethics Committee (8675/002) and local approvals will be obtained as appropriate. Results will be published in peer-reviewed journals using an open access format and presented at academic conferences. We will also publicise our findings on the Marie Curie website.Trial registration numberNCT03360812; Pre-results.

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35 Online randomised controlled trial to improve clinical estimates of survival (ORACLES): study design

BMJ Supportive & Palliative Care ◽

10.1136/bmjspcare-2018-mariecurie.35 ◽

2018 ◽

Vol 8 (3) ◽

pp. 373.1-373 ◽

Cited By ~ 1

Author(s):

Linda Oostendorp ◽

Nicola White ◽

Priscilla Harries ◽

Sarah Yardley ◽

Christopher Tomlinson ◽

...

Keyword(s):

Palliative Care ◽

Medical Students ◽

Randomised Controlled Trial ◽

Care Pathway ◽

Low Cost ◽

Controlled Trial ◽

Online Training ◽

List Type ◽

More Care ◽

Randomised Controlled

IntroductionClinicians often struggle to recognise whether palliative care patients are imminently dying.1 2 A previous study identified the factors that expert palliative care doctors (with demonstrated prognostic skills) had used to judge the probability of patients dying within 72 hours.Aim and methodsTo evaluate whether an online training resource can teach medical students to formulate survival estimates for palliative care patients that are more similar to experts’ estimates. In this online randomised controlled trial we will recruit 128 students in the penultimate/final year of medical school. Participants are asked to review three series of vignettes describing patients referred to palliative care and provide estimates (0%–100%) about the probability that patients will die within 72 hours. After the first series of vignettes students in the intervention arm are given access to the training resource showing how experts weighted the various symptoms/signs. Participants are asked to complete a second series of vignettes and then a third series after two weeks to assess if any effect has been maintained.ResultsStudents’ survival estimates will be correlated with experts’ estimates to determine the baseline level of agreement and any changes following the intervention. The primary outcome will be the survival estimates provided in the second series of vignettes. Secondary outcomes include the estimates provided at the follow-up the weighting of symptoms/signs and levels of discrimination and consistency.ConclusionThis study will provide evidence about whether a brief low-cost online training resource can influence how medical students make prognostic decisions in an experimental setting.References. Neuberger J. More care less pathway: A review of the liverpool care pathway.Department of Health2013. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/212450/Liverpool_Care_Pathway.pdf [Accessed: 30thMay 2018]. White N, Reid F, Harris A, Harries P, Stone P. A systematic review of predictions of survival in palliative care: How accurate are clinicians and who are the experts?PLoS One25 August 2016;11(8):e0161407. Available from: http://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0161407&type=printable [Accessed: 30th May 2018]

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Does acupressure help reduce nausea and vomiting in palliative care patients? A double blind randomised controlled trial

BMJ Supportive & Palliative Care ◽

10.1136/bmjspcare-2020-002434 ◽

2020 ◽

pp. bmjspcare-2020-002434

Author(s):

Paul Perkins ◽

Anne Parkinson ◽

Rebecca Parker ◽

Alison Blaken ◽

Ralph K Akyea

Keyword(s):

Palliative Care ◽

Randomised Controlled Trial ◽

Advanced Cancer ◽

Controlled Trial ◽

Acupuncture Point ◽

Nausea And Vomiting ◽

Specialist Palliative Care ◽

Double Blind ◽

Anticancer Treatment ◽

Randomised Controlled

IntroductionNausea and vomiting are common symptoms for patients with advanced cancer. While there is evidence for acupuncture point stimulation for treatment of these symptoms for patients having anticancer treatment, there is little for when they are not related to such treatment.ObjectiveTo determine whether acupressure at the pericardium 6 site can help in the treatment of nausea and vomiting suffered by palliative care patients with advanced cancer.Materials and methodsDouble blind randomised controlled trial—active versus placebo acupressure wristbands. In-patients with advanced cancer in two specialist palliative care units who fitted either or both of the following criteria were approached: Nausea that was at least moderate; Vomiting daily on average for the prior 3 days.Results57 patients were randomised to have either active or placebo acupressure wristbands. There was no difference in any of the outcome measures between the two groups: change from baseline number of vomits; Visual Analogue Scale for ‘did acupressure wristbands help you to feel better?’; total number of as needed doses of antiemetic medication; need for escalation of antiemetics.ConclusionsIn contrast to a previously published feasibility study, active acupressure wristbands were no better than placebo for specialist palliative care in-patients with advanced cancer and nausea and vomiting.

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A Feasibility Study of the Mistletoe and Breast Cancer (MAB) Trial: A Protocol for a Randomised Double-blind Controlled Trial

10.21203/rs.3.rs-50668/v1 ◽

2020 ◽

Author(s):

Susan Bryant ◽

Lorna Duncan ◽

Gene Feder ◽

Alyson Huntley

Keyword(s):

Breast Cancer ◽

Randomised Controlled Trial ◽

Feasibility Study ◽

Controlled Trial ◽

Locally Advanced ◽

Cochrane Review ◽

Double Blind ◽

Randomised Controlled ◽

The Uk ◽

Mistletoe Therapy

Abstract Background: A Cochrane review of mistletoe therapy concludes that there is some evidence that mistletoe extracts may offer benefits on measures of quality of life during chemotherapy for breast cancer, but these results need replication. Our aim was to test the feasibility of a placebo controlled, double blind randomised controlled trial of mistletoe therapy in patients with breast cancer undergoing chemotherapy with or without radiotherapy. Methods/design: A placebo controlled, double blind randomised controlled trial of mistletoe therapy in patients with breast cancer. There will be three arms (groups) in the trial: Iscador M, Iscador P, with physiological saline as the placebo. The aim is to recruit 45 adult patients with a new diagnosis of early or locally advanced breast cancer, up to 12 weeks following definitive breast surgery whose standard treatment plan includes chemotherapy with or without radiotherapy. They will be taught to administer the MAB therapies subcutaneously and will titrate up to their optimal dose. MAB therapy will continue throughout their standard chemotherapy and radiotherapy and one month beyond. The main outcome of the MAB study is the feasibility of conducting such a trial within the NHS in order to inform a future fully powered investigative trial. Feasibility will be measured through recruitment, retention and patient experience using clinical research forms, patient diaries, cancer-related questionnaires and qualitative interviews conducted with both patients and oncology staff.Discussion: This trial is the first of its kind in the UK. Currently mistletoe therapy is mostly available through private practice in the UK. Completion of this feasibility study will support applications for further funding for a fully powered randomised controlled trial which will measure effectiveness and cost-effectiveness of this herbal therapy.

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Online training improves medical students’ ability to recognise when a person is dying: The ORaClES randomised controlled trial

Palliative Medicine ◽

10.1177/0269216319880767 ◽

2019 ◽

Vol 34 (1) ◽

pp. 134-144

Author(s):

Nicola White ◽

Linda JM Oostendorp ◽

Christopher Tomlinson ◽

Sarah Yardley ◽

Federico Ricciardi ◽

...

Keyword(s):

Decision Making ◽

Medical Students ◽

Randomised Controlled Trial ◽

Learning Effect ◽

Controlled Trial ◽

Intervention Group ◽

Online Training ◽

Absolute Difference ◽

Randomised Controlled ◽

Time Point

Background: Recognising dying is a key clinical skill for doctors, yet there is little training. Aim: To assess the effectiveness of an online training resource designed to enhance medical students’ ability to recognise dying. Design: Online multicentre double-blind randomised controlled trial (NCT03360812). The training resource for the intervention group was developed from a group of expert palliative care doctors’ weightings of various signs/symptoms to recognise dying. The control group received no training. Setting/participants: Participants were senior UK medical students. They reviewed 92 patient summaries and provided a probability of death within 72 hours (0% certain survival – 100% certain death) pre, post, and 2 weeks after the training. Primary outcome: (1) Mean Absolute Difference (MAD) score between participants’ and the experts’ scores, immediately post intervention. Secondary outcomes: (2) weight attributed to each factor, (3) learning effect and (4) level of expertise (Cochran–Weiss–Shanteau (CWS)). Results: Out of 168 participants, 135 completed the trial (80%); 66 received the intervention (49%). After using the training resource, the intervention group had better agreement with the experts in their survival estimates ( δMAD = −3.43, 95% CI −0.11 to −0.34, p = <0.001) and weighting of clinical factors. There was no learning effect of the MAD scores at the 2-week time point ( δMAD = 1.50, 95% CI −0.87 to 3.86, p = 0.21). At the 2-week time point, the intervention group was statistically more expert in their decision-making versus controls (intervention CWS = 146.04 (SD 140.21), control CWS = 110.75 (SD 104.05); p = 0.01). Conclusion: The online training resource proved effective in altering the decision-making of medical students to agree more with expert decision-making.

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Does fluoxetine improve recovery after stroke?

BMJ ◽

10.1136/bmj.l1029 ◽

2019 ◽

pp. l1029

Author(s):

Rob Cook ◽

Vaughan Thomas ◽

Rosie Martin

Keyword(s):

Randomised Controlled Trial ◽

Health Technology Assessment ◽

Technology Assessment ◽

Functional Outcomes ◽

Controlled Trial ◽

Health Technology ◽

Double Blind ◽

Health Technology Assessment Programme ◽

Randomised Controlled ◽

The Uk

The study FOCUS Trial Collaboration. Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial. Lancet 2019;393:256-74. The study was funded by the UK Stroke Association and the NIHR Health Technology Assessment Programme project number 13/04/30. To read the full NIHR Signal, go to: https://discover.dc.nihr.ac.uk/content/signal-000729/a-commonly-used-antidepressant-doesnt-improve-recovery-after-stroke

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