Standard care informed by the result of a placental growth factor blood test versus standard care alone in women with reduced fetal movement at or after 36+0 weeks’ gestation: a pilot randomised controlled trial

ObjectivesThis study aimed to investigate if the use of a transition team was feasible for patients with diabetes being discharged from hospital on injectable diabetes therapies.DesignPilot, randomised controlled trial.SettingThe trial was conducted between 2014 and 2016 conjointly by a tertiary referral hospital and a community healthcare provider.ParticipantsHospital inpatients (n=105) on new injectable diabetes therapies were randomised 1:1 to transition team or standard care. The transition team received in-home diabetes education 24–48 hours postdischarge, with endocrinologist review 2–4 weeks and 16 weeks postdischarge.Main outcome measuresThe primary outcome was feasibility, defined by percentage of patients successfully receiving the intervention. Secondary outcomes included safety, defined by hospital readmission and emergency department presentations within 16 weeks postrandomisation, and treatment satisfaction, measured using Diabetes Treatment Satisfaction Questionnaire (DTSQ). Exploratory outcomes included length of stay (LOS) and change in haemoglobin A1c (HbA1c) throughout the study.ResultsThe intervention was deemed feasible (85% (95% CI 73% to 94%)). No difference in safety between groups was detected. No difference in change in HbA1c between groups was detected (standard care median HbA1c −1.5% (IQR −3.7% to −0.2%) vs transition team median HbA1c −1.9% (IQR −3.8% to −0.2%), p=0.83). There was a trend towards reduced LOS in the transition team group (per protocol, standard care median LOS 8 (IQR 5.5–12); transition team median LOS 6 (IQR 3–12), p=0.06). There was a significant improvement in patient satisfaction in the transition team (standard care median 10.5 (IQR 8.5–16); transition team DTSQ change version median 15 (IQR 10–17.5), p=0.047), although interpretability is limited by missing data.ConclusionThis study demonstrated that the use of a novel transition diabetes team is a feasible alternative model of care.

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PP28 ‘They are not silly people – they know the difference’: clinician focus group views on a pilot randomised controlled trial of prehospital continuous positive airway pressure (CPAP)

Emergency Medicine Journal ◽

10.1136/emermed-2019-999abs.28 ◽

2019 ◽

Vol 36 (10) ◽

pp. e12.2-e13

Author(s):

Joshua Miller ◽

Samuel Keating ◽

Alex Scott ◽

Gordon Fuller ◽

Steve Goodacre

Keyword(s):

Continuous Positive Airway Pressure ◽

Randomised Controlled Trial ◽

Focus Groups ◽

Airway Pressure ◽

Standard Care ◽

Positive Airway Pressure ◽

Controlled Trial ◽

Trial Participation ◽

Pilot Randomised Controlled Trial ◽

Randomised Controlled

BackgroundContinuous positive airway pressure (CPAP) is not in widespread use in UK ambulance services, but could benefit patients with acute respiratory failure (ARF). As a new treatment in this context, clinician acceptability is an important factor in the feasibility of conducting definitive research in the prehospital arena.MethodsAs part of a pilot randomised controlled trial (the ACUTE study), nine trial-trained paramedics took part in three semi-structured focus groups. 204 trained staff had been given the opportunity to take part. The sample included six staff who had recruited to the trial, one who had not, and two who had withdrawn from it. Audio-recordings were transcribed and analysed thematically.ResultsParticipants described facilitators to trial participation including: clear eligibility criteria and patient documentation, access to demonstration equipment, training away from the work environment, and repeated patient recruitment. Barriers to taking part included: the lack of protected time for training, inadequate workplace facilities for the electronic learning package used, adverse responses by receiving hospital staff, and infrequent patient exposure. Both paramedics who withdrew cited the inconvenience of carrying packs each shift. Some participants described anxiety and distress when opening packs to find a standard-care mask, and reported patients having similar reactions.ConclusionsFuture researchers could promote improved workplace computing facilities and increased provision of face-to-face training days, which were praised by participants in these focus groups, but limited to a single event distant from some staff. Greater stakeholder engagement by researchers could reduce the difficulties at hospital handover reported by some ambulance staff. Where blinding is not possible, the perceptions of clinicians and patients should be considered carefully, as this study shows both may have adverse emotional responses to being treated with standard care, particularly when prospective consent discussions describe the trial intervention as potentially beneficial.

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Pilot Randomised Controlled Trial of Cardiac Rehabilitation vs. Standard Care after Aortic Aneurysm Repair to reduce Adverse Cardiovascular Events

http://isrctn.org/> ◽

10.1186/isrctn65746249 ◽

2014 ◽

Author(s):

Sandeep Bahia

Keyword(s):

Randomised Controlled Trial ◽

Aortic Aneurysm ◽

Cardiac Rehabilitation ◽

Cardiovascular Events ◽

Standard Care ◽

Controlled Trial ◽

Pilot Randomised Controlled Trial ◽

Randomised Controlled ◽

Aneurysm Repair ◽

Aortic Aneurysm Repair

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Predicting intrapartum fetal compromise at term using the cerebroplacental ratio and placental growth factor levels (PROMISE) study: randomised controlled trial protocol

BMJ Open ◽

10.1136/bmjopen-2018-022567 ◽

2018 ◽

Vol 8 (8) ◽

pp. e022567 ◽

Cited By ~ 4

Author(s):

Helen Sherrell ◽

Vicky Clifton ◽

Sailesh Kumar

Keyword(s):

Growth Factor ◽

Randomised Controlled Trial ◽

Screening Test ◽

Controlled Trial ◽

Perinatal Outcomes ◽

Placental Growth Factor ◽

Cerebroplacental Ratio ◽

Adverse Perinatal Outcomes ◽

Randomised Controlled ◽

Fetal Compromise

IntroductionIntrapartum complications are a major contributor to adverse perinatal outcomes, including stillbirth, hypoxic–ischaemic brain injury and subsequent longer term disability. In many cases, hypoxia develops as a gradual process due to the inability of the fetus to tolerate the stress of parturition suggesting reduced fetoplacental reserve before labour commences. The fetal cerebroplacental ratio (CPR) is an independent predictor of intrapartum fetal compromise, poor acid base status at birth and of neonatal unit admission at term. Similarly, circulating maternal levels of placental growth factor (PlGF) are lower in pregnancies complicated by placental dysfunction. This paper outlines the protocol for the PROMISE Study, which aims to determine if the introduction of a prelabour screening test for intrapartum fetal compromise combining the CPR and maternal PlGF level results in a reduction of adverse perinatal outcomes.Methods and analysisThis is a single-site, non-blinded, individual patient randomised controlled trial of a screening test performed at term, combining the fetal CPR and maternal serum PlGF. Women with a singleton, non-anomalous pregnancy will be recruited after 34 weeks’ gestation and randomised to either receive the screening test or not. Screened pregnancies determined to be at risk will be recommended induction of labour. Demographic, obstetric history and antenatal data will be collected at enrolment, and perinatal outcomes will be recorded after delivery. Relative risks and 95% CIs will be reported for the primary outcome. Regression techniques will be used to examine the influence of prognostic factors on the primary and secondary outcomes.Ethics and disseminationThis study has been reviewed and approved by the Mater Human Research Ethics Committee (Reference: HREC EC00332) and will follow the principles of Good Clinical Practice. The study results will be disseminated at national and international conferences and published in peer-reviewed journals.Trial registration numberACTRN12616001009404; Pre-results.

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Evaluating acupuncture and standard care for pregnant women with back pain: the EASE Back pilot randomised controlled trial (ISRCTN49955124)

Pilot and Feasibility Studies ◽

10.1186/s40814-016-0107-6 ◽

2016 ◽

Vol 2 (1) ◽

Cited By ~ 10

Author(s):

Annette Bishop ◽

◽

Reuben Ogollah ◽

Bernadette Bartlam ◽

Panos Barlas ◽

...

Keyword(s):

Back Pain ◽

Randomised Controlled Trial ◽

Pregnant Women ◽

Standard Care ◽

Controlled Trial ◽

Pilot Randomised Controlled Trial ◽

Randomised Controlled

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Protocol for a pilot randomised controlled trial of metformin in pre-diabetes after kidney transplantation: the Transplantation and Diabetes (Transdiab) study

BMJ Open ◽

10.1136/bmjopen-2017-016813 ◽

2017 ◽

Vol 7 (8) ◽

pp. e016813 ◽

Cited By ~ 11

Author(s):

Basil Alnasrallah ◽

Helen Pilmore ◽

Paul Manley

Keyword(s):

Clinical Trials ◽

Kidney Transplantation ◽

Renal Transplantation ◽

New Zealand ◽

Randomised Controlled Trial ◽

Standard Care ◽

Controlled Trial ◽

Significant Morbidity ◽

Pilot Randomised Controlled Trial ◽

Randomised Controlled

IntroductionPost-transplant diabetes mellitus (PTDM) is a common complication of kidney transplantation and is associated with significant morbidity and mortality. In the general population, metformin has been used for diabetes prevention in high-risk individuals. Improving insulin sensitivity is one of many proven favourable effects of metformin. Despite the high incidence of PTDM in kidney transplant recipients, there is a lack of evidence for the role of metformin in the prevention of diabetes in this setting.Methods and analysisTransplantation andDiabetes (Transdiab)is a single-centre, unblinded, pilot randomised controlled trial assessing the feasibility, tolerability and efficacy of metformin after renal transplantation in patients with impaired glucose tolerance (IGT). Participants will undergo an oral glucose tolerance test in the 4–12 weeks post-transplantation; those with IGT will be randomised to standard care or standard care and metformin 500 mg twice daily, and followed up for 12 months. The primary outcomes of the study will be the feasibility of recruitment, the tolerability of metformin assessed using the Gastrointestinal Symptom Rating Scale at 3 and 12 months, and the efficacy of metformin assessed by morning glucose and glycated haemoglobin at 3, 6, 9 and 12 months.Ethics and disseminationDespite the significant morbidity and mortality of PTDM, there are currently no randomised clinical trials assessing pharmacological interventions for its prevention after kidney transplantation. The Transdiab trial will thus provide important data on the feasibility, safety, tolerability and efficacy of metformin after renal transplantation in patients with IGT; this will facilitate undertaking larger multicentre trials of interventions to reduce the incidence or severity of diabetes after kidney transplantation. This study has been approved by the Northern B Health and Disability Ethics Committee of the Ministry of Health in New Zealand. On study completion, results are expected to be published in a peer-reviewed journal.Trial registration numberAustralian New Zealand Clinical Trials Registry Number: ACTRN12614001171606.

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