scholarly journals Oral morphine versus transmucosal diamorphine for breakthrough pain in children: methods and outcomes: UK (DIPPER study) consensus

2021 ◽  
pp. bmjspcare-2021-003278
Author(s):  
Emily Harrop ◽  
Christina Liossi ◽  
Liz Jamieson ◽  
Silke Gastine ◽  
Kate Oulton ◽  
...  
Keyword(s):  
Palliative Care ◽  
Randomised Controlled Trial ◽  
Breakthrough Pain ◽  
Controlled Trial ◽  
Nominal Group Technique ◽  
Oral Morphine ◽  
Nominal Group ◽  
Small Scale ◽  
Paediatric Palliative Care ◽  
Randomised Controlled

ObjectivesNo randomised controlled trials have been conducted for breakthrough pain in paediatric palliative care and there are currently no standardised outcome measures. The DIPPER study aims to establish the feasibility of conducting a prospective randomised controlled trial comparing oral and transmucosal administration of opioids for breakthrough pain. The aim of the current study was to achieve consensus on design aspects for a small-scale prospective study to inform a future randomised controlled trial of oral morphine, the current first-line treatment, versus transmucosal diamorphine.MethodsThe nominal group technique was used to achieve consensus on best practice for mode of administration, dose regimen and a range of suitable pain intensity outcome measures for transmucosal diamorphine in children and young people with breakthrough pain. An expert panel of ten clinicians in paediatric palliative care and three parent representatives participated. Consensus was achieved when agreement was reached and no further comments from participants were forthcoming.ResultsThe panel favoured the buccal route of administration, with dosing according to the recommendations in the Association for Paediatric Palliative Medicine formulary (fifth Edition, 2020). The verbal Numerical Rating Scale was selected to measure pain in children 8 years old and older, the Faces Pain Scale-Revised for children between 4 and 8 years old, and Face, Legs, Activity, Cry and Consolability (FLACC)/FLACC-Revised as the observational tools.ConclusionsThe nominal group technique allowed consensus to be reached for a small-scale, prospective, cohort study and provided information to inform the design of a randomised controlled trial.

scholarly journals Development of an optimised physiotherapist-led treatment protocol for lateral elbow tendinopathy: a consensus study using an online nominal group technique

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e053841
Author(s):  
Marcus Bateman ◽  
Benjamin Saunders ◽  
Chris Littlewood ◽  
Jonathan C Hill
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Treatment Options ◽  
Treatment Protocol ◽  
Nominal Group Technique ◽  
Trial Registration ◽  
Nominal Group ◽  
Lateral Elbow ◽  
Randomised Controlled ◽  
Lateral Elbow Tendinopathy

ObjectivesThere are a wide range of physiotherapy treatment options for people with lateral elbow tendinopathy (LET); however, previous studies have reported inconsistent approaches to treatment and a lack of evidence demonstrating clinical effectiveness. This study aimed to combine the best available research evidence with stakeholder perspectives to develop key components of an optimised physiotherapist-led treatment protocol for testing in a future randomised controlled trial (RCT).DesignOnline consensus groups using nominal group technique (NGT), a systematic approach to building consensus using structured multistage meetings.SettingUK National Health Service (NHS).Participants10 physiotherapists with special interest in LET, 2 physiotherapy service managers and 3 patients who had experienced LET.InterventionsTwo consensus groups were conducted; the first meeting focused on agreeing the types of interventions to be included in the optimised treatment protocol; the second meeting focused on specific details of intervention delivery. Participants were sent an evidence summary of available treatments for LET prior to the first meeting. All treatment options were discussed before anonymous voting and ranking of priority. Consensus for inclusion of each treatment option was set at ≥70% based on OMERACT guidelines. Options with 30%–69% agreement were discussed again, and a second vote was held, allowing for a change of opinion.ResultsThe optimised physiotherapist-led treatment package included: advice and education, exercise therapy and orthotics. Specific components for each of these interventions were also agreed such as: condition-specific advice, health-promotion advice, exercise types, exercise into ‘acceptable’ levels of pain, exercise dosage and type of orthoses. Other treatment options including electrotherapy, acupuncture and manual therapy were excluded.ConclusionAn optimised physiotherapist-led treatment protocol for people with LET was successfully developed using an online NGT consensus approach. This intervention is now ready for testing in a future pilot/feasibility RCT to contribute much needed evidence about the treatment of LET.Trial registration numberThis is the pre-cursor to the OPTimisE Pilot and Feasibility Randomised Controlled Trial. Registration: https://www.isrctn.com/ISRCTN64444585

scholarly journals Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e025692 ◽  
Author(s):  
Corita R Grudzen ◽  
Deborah J Shim ◽  
Abigail M Schmucker ◽  
Jeanne Cho ◽  
Keith S Goldfeld
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Palliative Care ◽  
Randomised Controlled Trial ◽  
Case Management ◽  
Controlled Trial ◽  
Chronic Obstructive ◽  
Randomised Controlled ◽  
End Stage

IntroductionEmergency department (ED)-initiated palliative care has been shown to improve patient-centred outcomes in older adults with serious, life-limiting illnesses. However, the optimal modality for providing such interventions is unknown. This study aims to compare nurse-led telephonic case management to specialty outpatient palliative care for older adults with serious, life-limiting illness on: (1) quality of life in patients; (2) healthcare utilisation; (3) loneliness and symptom burden and (4) caregiver strain, caregiver quality of life and bereavement.Methods and analysisThis is a protocol for a pragmatic, multicentre, parallel, two-arm randomised controlled trial in ED patients comparing two established models of palliative care: nurse-led telephonic case management and specialty, outpatient palliative care. We will enrol 1350 patients aged 50+ years and 675 of their caregivers across nine EDs. Eligible patients: (1) have advanced cancer (metastatic solid tumour) or end-stage organ failure (New York Heart Association class III or IV heart failure, end-stage renal disease with glomerular filtration rate <15 mL/min/m2, or global initiative for chronic obstructive lung disease stage III, IV or oxygen-dependent chronic obstructive pulmonary disease); (2) speak English; (3) are scheduled for ED discharge or observation status; (4) reside locally; (5) have a working telephone and (6) are insured. Patients will be excluded if they: (1) have dementia; (2) have received hospice care or two or more palliative care visits in the last 6 months or (3) reside in a long-term care facility. We will use patient-level block randomisation, stratified by ED site and disease. Effectiveness will be compared by measuring the impact of each intervention on the specified outcomes. The primary outcome will measure change in patient quality of life.Ethics and disseminationInstitutional Review Board approval was obtained at all study sites. Trial results will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03325985; Pre-results.

scholarly journals Healthcare professionals’ views of the use of oral morphine and transmucosal diamorphine in the management of paediatric breakthrough pain and the feasibility of a randomised controlled trial: A focus group study (DIPPER)

2021 ◽  
pp. 026921632110087
Author(s):  
Liz Jamieson ◽  
Emily Harrop ◽  
Margaret Johnson ◽  
Christina Liossi ◽  
Christine Mott ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Healthcare Professionals ◽  
Breakthrough Pain ◽  
Controlled Trial ◽  
Oral Morphine ◽  
Oral Route ◽  
Focus Group Study ◽  
Framework Approach ◽  
Randomised Controlled ◽  
The Uk

Background: Oral morphine is frequently used for breakthrough pain but the oral route is not always available and absorption is slow. Transmucosal diamorphine is administered by buccal, sublingual or intranasal routes, and rapidly absorbed. Aim: To explore the perspectives of healthcare professionals in the UK caring for children with life-limiting conditions concerning the assessment and management of breakthrough pain; prescribing and administration of transmucosal diamorphine compared with oral morphine; and the feasibility of a comparative clinical trial. Design/ participants: Three focus groups, analysed using a Framework approach. Doctors, nurses and pharmacists ( n = 28), caring for children with life-limiting illnesses receiving palliative care, participated. Results: Oral morphine is frequently used for breakthrough pain across all settings; with transmucosal diamorphine largely limited to use in hospices or given by community nurses, predominantly buccally. Perceived advantages of oral morphine included confidence in its use with no requirement for specific training; disadvantages included tolerability issues, slow onset, unpredictable response and unsuitability for patients with gastrointestinal failure. Perceived advantages of transmucosal diamorphine were quick onset and easy administration; barriers included lack of licensed preparations and prescribing guidance with fears over accountability of prescribers, and potential issues with availability, preparation and palatability. Factors potentially affecting recruitment to a trial were patient suitability and onerousness for families, trial design and logistics, staff time and clinician engagement. Conclusions: There were perceived advantages to transmucosal diamorphine, but there is a need for access to a safe preparation. A clinical trial would be feasible provided barriers were overcome.

scholarly journals Effect of home-based specialised palliative care and dyadic psychological intervention on caregiver anxiety and depression: a randomised controlled trial

2018 ◽  
Vol 119 (11) ◽  
pp. 1307-1315 ◽  
Author(s):  
Annika von Heymann-Horan ◽  
Pernille Bidstrup ◽  
Mai-Britt Guldin ◽  
Per Sjøgren ◽  
Elisabeth Anne Wreford Andersen ◽  
...  
Keyword(s):  
Palliative Care ◽  
Randomised Controlled Trial ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Anxiety And Depression ◽  
Home Based ◽  
Randomised Controlled ◽  
Caregiver Anxiety

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

2018 ◽  
Vol 8 (3) ◽  
pp. 373.1-373 ◽  
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]

scholarly journals Protocol for a feasibility randomised controlled trial of a musculoskeletal exercise intervention versus usual care for children with haemophilia

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e029474 ◽  
Author(s):  
Ferhana Hashem ◽  
Melanie Bladen ◽  
Liz Carroll ◽  
Charlene Dodd ◽  
Wendy I Drechsler ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Muscle Strength ◽  
Usual Care ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Small Scale ◽  
Framework Analysis ◽  
Muscle Strengthening ◽  
Training Requirements ◽  
Randomised Controlled

IntroductionHaemophilia is a rare, inherited disorder in which blood does not clot normally, resulting in bleeding into joints and muscles. Long-term consequence is disabling joint pain, stiffness, muscle weakness, atrophy and reduced mobility. The purpose of this proposed feasibility of a randomised controlled trial (RCT) is to test the feasibility of an age-appropriate physiotherapy intervention designed to improve muscle strength, posture and the way boys use their joints during walking and everyday activities.Methods and analysisA small-scale two-centre RCT of a 12-week muscle strengthening exercise intervention versus usual care for young children with haemophilia will be conducted. Primary outcomes will be safety and adherence to the exercise intervention. Secondary outcomes will include recruitment, retention and adverse event rates, clinical data, muscle strength, joint biomechanics and foot loading patterns during walking, 6 min timed walk, timed-up-and-down-stairs, EQ-5D-Y, participants’ perceptions of the study, training requirements and relevant costs. Recruitment, follow-up, safety and adherence rates will be described as percentages. Participant diary and interview data will be analysed using a framework analysis. Demographic and disease variable distributions will be analysed for descriptive purposes and covariant analysis. Estimates of differences between treatment arms (adjusted for baseline) and 75% and 95% CIs will be calculated.Ethics and disseminationThe study has ethical approval from the London—Fulham Research Ethics Committee (17/LO/2043) as well as Health Research Authority approval. As well as informing the design of the definitive trial, results of this study will be presented at local, national and international physiotherapy and haemophilia meetings as well as manuscripts submitted to peer-reviewed journals. We will also share the main findings of the study to all participants and the Haemophilia Society.

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