Comparing levonorgestrel intrauterine system versus hysteroscopic resection in patients with postmenstrual spotting related to a niche in the caesarean scar (MIHYS NICHE trial): protocol of a randomised controlled trial

IntroductionRecently, the rate of caesarean sections (CS) worldwide has risen and CS-associated complications such as niche have increased substantially. Until now, evidence-based clinical guidelines for the treatment of niche-related symptoms remain absent. In patients with postmenstrual spotting, it has not been studied if the effect of levonorgestrel 52 mg intrauterine system (LNG-IUS 52 mg) is superior to that of hysteroscopy. This study will answer the question of whether LNG-IUS 52 mg is more effective in improving postmenstrual spotting than hysteroscopic niche resection in women with niche-related spotting at 6 months after randomisation.Methods and analysisThis is a randomised controlled trial. A total of 208 women with postmenstrual spotting related to niche in the caesarean uterine scar of at least 2 mm and residual myometrium of at least 2.2 mm evaluated by MRI will be included. Women desiring to conceive within 1 year, with contraindications for LNG-IUS 52 mg or hysteroscopic surgery will be excluded. After informed consent is obtained, eligible women will be randomly allocated to LNG-IUS 52 mg or hysteroscopic niche resection at 1:1. The primary outcome is the efficacy in reducing postmenstrual spotting at 6 months after randomisation. The secondary outcomes include menstrual pattern, total days of blood loss per month, rate of amenorrhoea, side effects and complications.We will use a Visual Analogue Scale for chronic pelvic pain, urological symptoms and women’s satisfaction (five-point Likert scale).Ethics and disseminationThe study was approved by the local medical ethics committee and by the Institutional Review Board of the International Peace Maternity and Child Health Hospital, Shanghai, China (No. GKLW 2019-08). Participants will sign a written informed consent before participation. The results of this study will be submitted to a peer-reviewed journal for publication.Trial registration numberChiCTR1900025677.

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Electroacupuncture for stress-predominant mixed urinary incontinence: a protocol for a three-armed randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-038452 ◽

2021 ◽

Vol 11 (1) ◽

pp. e038452

Author(s):

Yuanjie Sun ◽

Yan Liu ◽

Huan Chen ◽

Yan Yan ◽

Zhishun Liu

Keyword(s):

Urinary Incontinence ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Sham Acupuncture ◽

Mixed Urinary Incontinence ◽

Incontinence Episode ◽

P Value ◽

Institutional Review ◽

Registration Number ◽

Randomised Controlled

IntroductionEvidence specific for stress-predominant mixed urinary incontinence is still lacking at present, and acupuncture may relieve the symptoms. We plan to conduct this multi-centre, three-armed, randomised controlled trial to investigate the efficacy and safety of electroacupuncture among women with stress-predominant mixed urinary incontinence.Methods and analysisThe trial will be conducted at five hospitals in China. Two hundred thirty-two eligible women will be randomly assigned (2:1:1) to the electroacupuncture, sham electroacupuncture or waiting-list group to receive either 24-session acupuncture/sham acupuncture treatment over 8 weeks and 24-week follow-up or 20-week watchful waiting. The primary outcome is the proportion of participants with at least 50% reduction in mean 24-hour stress incontinence episode frequencies from baseline to week 8. The outcome will be analysed with the intention to treatpopulation (defined as participants randomised) with a two-sided p value of less than 0.05 considered significant.Ethics and disseminationThe protocol has been approved by Guang’anmen Hospital Institutional Review Board (2019-241-KY). Detailed information of the trial will be informed to the participants, and written informed consent will be obtained from every participant. Results of the trial are expected to be published in a peer-reviewed journal.Trial registration numberClinicalTrials.gov Registry (NCT04299932).

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Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burn injuries: a prospective randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-039981 ◽

2021 ◽

Vol 11 (1) ◽

pp. e039981

Author(s):

Maleea Denise Holbert ◽

Roy M Kimble ◽

Mark Chatfield ◽

Bronwyn R Griffin

Keyword(s):

Randomised Controlled Trial ◽

Repeated Measures ◽

Controlled Trial ◽

Geometric Mean ◽

First Aid ◽

Self Report ◽

Thermal Burn ◽

Pain Scores ◽

Registration Number ◽

Randomised Controlled

ObjectiveTo compare the effectiveness of two acute burn dressings, Burnaid hydrogel dressing and plasticised polyvinylchloride film, on reducing acute pain scores in paediatric burn patients following appropriate first aid.DesignSingle-centre, superiority, two-arm, parallel-group, prospective randomised controlled trial.Participants and settingPaediatric patients (aged ≤16) presenting to the Emergency Department at the Queensland Children’s Hospital, Brisbane, Australia, with an acute thermal burn were approached for participation in the trial from September 2017–September 2018.InterventionsPatients were randomised to receive either (1) Burnaid hydrogel dressing (intervention) or (2) plasticised polyvinylchloride film (Control) as an acute burn dressing.Primary and secondary outcomesObservational pain scores from nursing staff assessed 5 min post application of the randomised dressing, measured using the Face Legs Activity Cry and Consolability Scale was the primary outcome. Repeated measures of pain, stress and re-epithelialisation were also collected at follow-up dressing changes until 95% wound re-epithelialisation occurred.ResultsSeventy-two children were recruited and randomised (n=37 intervention; n=35 control). No significant between-group differences in nursing (mean difference: −0.1, 95% CI −0.7 to 0.5, p=0.72) or caregiver (MD: 1, 95% CI −8 to 11, p=0.78) observational pain scores were identified. Moreover, no significant differences in child self-report pain (MD: 0.3, 95% CI −1.7 to 2.2, p=0.78), heart rate (MD: −3, 95% CI −11 to 5, p=0.41), temperature (MD: 0.6, 95% CI −0.13 to 0.24, p=0.53), stress (geometric mean ratio: 1.53, 95% CI 0.93 to 2.53, p=0.10), or re-epithelialisation rates (MD: −1, 95% CI −3 to 1, p=0.26) were identified between the two groups.ConclusionsA clear benefit of Burnaid hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burns was not identified in this investigation.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12617001274369).

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Open-label placebo for insomnia (OPIN): study protocol for a cohort multiple randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-044045 ◽

2021 ◽

Vol 11 (2) ◽

pp. e044045

Author(s):

Ben Colagiuri ◽

Louise Sharpe ◽

Zahava Ambarchi ◽

Nick Glozier ◽

Delwyn Bartlett ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Treatment Period ◽

Controlled Trial ◽

Severity Index ◽

Open Label ◽

Human Research Ethics ◽

Sleep Parameters ◽

Registration Number ◽

Randomised Controlled ◽

Insomnia Symptoms

IntroductionInsomnia is a prevalent sleep disorder that causes substantial personal and societal harm. There is evidence that placebo interventions can reduce insomnia symptoms, but this research has involved deceptively administering the placebo under the guise of a real medication (conventional placebo, CP), which has obvious ethical constraints. Open-label placebo (OLP) treatment, in which a placebo is administered with full disclosure that there are no active ingredients, has been proposed as a method of using the placebo effect ethically, but the efficacy and acceptability of OLP for insomnia is currently unknown.Methods and analysisThis study uses a cohort multiple randomised controlled trial design to compare OLP, CP and no treatment for insomnia. Two-hundred and sixty-seven participants with self-reported insomnia symptoms (Insomnia Severity Index, ISI ≥10) will be recruited into an observational study and have their sleep monitored over a 2-week period. Participants will then be randomised to one of three groups: invite to OLP, invite to CP described deceptively as a new pharmacological agent, or no invite/observational control. Those in OLP and CP accepting the invite receive identical placebos for a 2-week treatment period while sleep is monitored in all participants. The primary outcome is ISI at the end of the treatment period. Secondary outcomes include treatment uptake and clinically significant response rates, objective and subjective sleep parameters, fatigue, mood, expectancy, treatment satisfaction and side effects. Predictors of uptake and responses to OLP and CP will be explored.Ethics and disseminationThe trial has been approved by The University of Sydney Human Research Ethics Committee. Written informed consent is obtained from every participant. OLP and CP participants accepting the invite undergo an additional consent process. Results will be disseminated via peer-reviewed conference proceedings and publications.Trial registration numberACTRN12620001080910.

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Effects of accelerated versus standard care surgery on the risk of acute kidney injury in patients with a hip fracture: a substudy protocol of the hip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) international randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-033150 ◽

2019 ◽

Vol 9 (9) ◽

pp. e033150 ◽

Cited By ~ 2

Author(s):

Flavia K Borges ◽

P J Devereaux ◽

Meaghan Cuerden ◽

Mohit Bhandari ◽

Ernesto Guerra-Farfán ◽

...

Keyword(s):

Acute Kidney Injury ◽

Surgical Treatment ◽

Hip Fracture ◽

Randomised Controlled Trial ◽

Standard Care ◽

Controlled Trial ◽

Kidney Injury ◽

Registration Number ◽

Randomised Controlled ◽

Care Surgery

IntroductionInflammation, dehydration, hypotension and bleeding may all contribute to the development of acute kidney injury (AKI). Accelerated surgery after a hip fracture can decrease the exposure time to such contributors and may reduce the risk of AKI.Methods and analysisHip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) is a multicentre, international, parallel-group randomised controlled trial (RCT). Patients who suffer a hip fracture are randomly allocated to either accelerated medical assessment and surgical repair with a goal of surgery within 6 hours of diagnosis or standard care where a repair typically occurs 24 to 48 hours after diagnosis. The primary outcome of this substudy is the development of AKI within 7 days of randomisation. We anticipate at least 1998 patients will participate in this substudy.Ethics and disseminationWe obtained ethics approval for additional serum creatinine recordings in consecutive patients enrolled at 70 participating centres. All patients provide consent before randomisation. We anticipate reporting substudy results by 2021.Trial registration numberNCT02027896; Pre-results.

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Patient experience of preheated and room temperature skin disinfection prior to cardiac device implantation: A randomised controlled trial

European Journal of Cardiovascular Nursing ◽

10.1177/1474515119900062 ◽

2020 ◽

Vol 19 (6) ◽

pp. 529-536

Author(s):

Camilla Wistrand ◽

Ulrica Nilsson ◽

Ann-Sofie Sundqvist

Keyword(s):

Randomised Controlled Trial ◽

Patient Experience ◽

Room Temperature ◽

Controlled Trial ◽

Cardiac Device ◽

Negative Experience ◽

Device Implantation ◽

Skin Disinfection ◽

Registration Number ◽

Randomised Controlled

Background: Clinically, patients often comment on the coolness of the skin disinfectant. However, scarce evidence is available regarding patients’ experience during intraoperative skin disinfection. Aims: The aim of this study was to describe and compare intraoperative patient experiences with preheated and room temperature skin disinfectant. Method: This randomised controlled trial included 220 patients undergoing cardiac device implantation. Patients allocated to preheated (36°C) or room temperature (20°C) chlorhexidine in 70% ethanol verbally answered an open-ended question regarding their experience with the skin disinfection. Results were assessed using a qualitative approach with comparative quantification. Results: The analysis resulted in nine categories describing the patients’ experiences with preheated and room temperature skin disinfection. Most of the patients described the skin disinfection process as a negative experience, which consisted of six categories: cold, smell, change in temperature, unpleasant, wet and painful. In addition, two neutral categories of response (nothing in particular and neither pleasant nor unpleasant) and one positive response (pleasant) emerged through the analysis. Preheated skin disinfection yielded significantly fewer negative experiences in the category cold (85% vs. 15%, P<0.0001) and significantly more positive experiences (66% vs. 34%, P<0.002). Neutral categories (neither pleasant nor unpleasant 65% vs. 35%, P=0.01, nothing in particular 74% vs. 26%, P<0.001) dominated after preheated skin disinfection. Conclusion: The use of preheated skin disinfection promotes a positive patient experience with skin disinfection. Trial registration: ClinicalTrials.gov registration number NCT02260479 ( https://clinicaltrials.gov/ct2/results?cond=preheated+skin+disinfection ).

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‘Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing’ (PIVOT with MI) trial: a protocol for a cluster randomised controlled trial of a clinician vaccine communication intervention

BMJ Open ◽

10.1136/bmjopen-2020-039299 ◽

2020 ◽

Vol 10 (8) ◽

pp. e039299

Author(s):

Douglas J Opel ◽

Jeffrey D Robinson ◽

Heather Spielvogle ◽

Christine Spina ◽

Kathleen Garrett ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Motivational Interviewing ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Communication Strategy ◽

Institutional Review Board ◽

Cluster Randomised ◽

Institutional Review ◽

Randomised Controlled ◽

Immunisation Status

IntroductionA key contributor to underimmunisation is parental refusal or delay of vaccines due to vaccine concerns. Many clinicians lack confidence in communicating with vaccine-hesitant parents (VHP) and perceive that their discussions will do little to change parents’ minds. Improving clinician communication with VHPs is critical to increasing childhood vaccine uptake.Methods and analysisWe describe the protocol for a cluster randomised controlled trial to test the impact of a novel, multifaceted clinician vaccine communication strategy on child immunisation status. The trial will be conducted in 24 primary care practices in two US states (Washington and Colorado). The strategy is called Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT with MI), and involves clinicians initiating the vaccine conversation with all parents of young children using the presumptive format, and among those parents who resist vaccines, pivoting to using MI. Our primary outcome is the immunisation status of children of VHPs at 19 months, 0 day of age expressed as the percentage of days underimmunised from birth to 19 months for 22 doses of eight vaccines recommended during this interval. Secondary outcomes include clinician experience communicating with VHPs, parent visit experience and clinician adherence to the PIVOT with MI communication strategy.Ethics and disseminationThis study is approved by the following institutional review boards: Colorado Multiple Institutional Review Board, Washington State Institutional Review Board and Swedish Health Services Institutional Review Board. Results will be disseminated through peer-reviewed manuscripts and conference presentations.Trial registration numberNCT03885232.

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Examining the effects of enhanced provider–patient communication on postoperative tonsillectomy pain: protocol of a randomised controlled trial performed by nurses in daily clinical care

BMJ Open ◽

10.1136/bmjopen-2016-015505 ◽

2017 ◽

Vol 7 (11) ◽

pp. e015505 ◽

Cited By ~ 1

Author(s):

Liesbeth M van Vliet ◽

Sandra van Dulmen ◽

Bram Thiel ◽

Gerard W van Deelen ◽

Stephanie Immerzeel ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Rating Scale ◽

Controlled Trial ◽

Clinical Care ◽

Numeric Rating Scale ◽

Study Results ◽

Audio Recordings ◽

Registration Number ◽

Randomised Controlled ◽

Care Ward

IntroductionPlacebo effects (true biopsychological effects not attributable to the active ingredients of medical technical interventions) can be attributed to several mechanisms, such as expectancy manipulation and empathy manipulation elicited by a provider’s communication. So far, effects have primarily been shown in laboratory settings. The aim of this study is to determine the separate and combined effects of expectancy manipulation and empathy manipulation during preoperative and postoperative tonsillectomy analgesia care on clinical adult patients’ outcomes.Methods and analysisUsing a two-by-two randomised controlled trial, 128 adult tonsillectomy patients will be randomly assigned to one out of four conditions differing in the level of expectancy manipulation (standard vs enhanced) and empathy manipulation (standard vs enhanced). Day care ward nurses are trained to deliver the intervention, while patients are treated via the standard analgesia protocol and hospital routines. The primary outcome, perceived pain, is measured via hospital routine by a Numeric Rating Scale, and additional prehospitalisation, perihospitalisation and posthospitalisation questionnaires are completed (until day 3, ie, 2 days after the operation). The manipulation is checked using audio recordings of nurse–patient interactions.Ethics and disseminationAlthough communication is manipulated, the manipulations do not cross norms or values of acceptable behaviour. Standard medical care is provided. The ethical committee of the UMC Utrecht and the local OLVG hospital committee approved the study. Results will be published via (inter)national peer-reviewed journals and a lay publication.Trial registration numberNTR5994; Pre-results.

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A Study to Inform the Design of a National Multicentre Randomised Controlled Trial to Evaluate If Reducing Serum Phosphate to Normal Levels Improves Clinical Outcomes including Mortality, Cardiovascular Events, Bone Pain, or Fracture in Patients on Dialysis

International Journal of Nephrology ◽

10.1155/2015/579434 ◽

2015 ◽

Vol 2015 ◽

pp. 1-12 ◽

Cited By ~ 4

Author(s):

Ramya Bhargava ◽

Philip A. Kalra ◽

Paul Brenchley ◽

Helen Hurst ◽

Alastair Hutchison

Keyword(s):

Randomised Controlled Trial ◽

Clinical Outcomes ◽

Cardiovascular Events ◽

Controlled Trial ◽

Drop Out ◽

Phosphate Binders ◽

Dialysis Patients ◽

Definitive Trial ◽

Registration Number ◽

Randomised Controlled

Background. Retrospective, observational studies link high phosphate with mortality in dialysis patients. This generates research hypotheses but does not establish “cause-and-effect.” A large randomised controlled trial (RCT) of about 3000 patients randomised 50 : 50 to lower or higher phosphate ranges is required to answer the key question: does reducing phosphate levels improve clinical outcomes? Whether such a trial is technically possible is unknown; therefore, a study is necessary to inform the design and conduct of a future, definitive trial.Methodology. Dual centre prospective parallel group study: 100 dialysis patients randomized to lower (phosphate target 0.8 to 1.4 mmol/L) or higher range group (1.8 to 2.4 mmol/L). Non-calcium-containing phosphate binders and questionnaires will be used to achieve target phosphate. Primary endpoint: percentage successfully titrated to required range and percentage maintained in these groups over the maintenance period. Secondary endpoints: consent rate, drop-out rates, and cardiovascular events.Discussion. This study will inform design of a large definitive trial of the effect of phosphate on mortality and cardiovascular events in dialysis patients. If phosphate lowering improves outcomes, we would be reassured of the validity of this clinical practice. If, on the other hand, there is no improvement, a reassessment of resource allocation to therapies proven to improve outcomes will result.Trial Registration Number. This trial is registered with ISRCTN registration numberISRCTN24741445.

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Use of scratchcards for allocation concealment in a prehospital randomised controlled trial

Emergency Medicine Journal ◽

10.1136/emermed-2018-207881 ◽

2018 ◽

pp. emermed-2018-207881 ◽

Cited By ~ 1

Author(s):

Leigh Keen ◽

Jenna Katherine Bulger ◽

Nigel Rees ◽

Helen Snooks ◽

Greg Fegan ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Prehospital Care ◽

Controlled Trial ◽

Allocation Concealment ◽

Prehospital Setting ◽

Random Allocation ◽

Registration Number ◽

Randomised Controlled ◽

Fascia Iliaca Compartment Block

BackgroundRapid Analgesia for Prehospital Hip Disruption was a small study designed to determine the feasibility of undertaking a randomised controlled trial (RCT) to test the clinical and cost-effectiveness of paramedics administering Fascia Iliaca Compartment Block as early prehospital pain relief to patients with a fractured hip. The objective was to devise a simple and effective method of random allocation concealment suitable for use by paramedics while in the emergency prehospital setting.MethodsScratchcards were produced using scratch-off silver stickers which concealed the trial arm allocation. Paramedics were each allocated a unique range of consecutive numbers, used as both the scratchcard number and the patient’s study ID. The cards were designed to allow the paramedic to write on the incident number, date and signature. A small envelope holding the cards was prepared for each paramedic. The study took place between 28 June 2016 and 31 July 2017 in the Swansea area.ResultsNineteen trial paramedics used 71 scratchcards throughout the study and reported no problems randomly allocating patients using the scratchcards. Five protocol deviations were reported in relation to scratchcard use. On auditing the scratchcards, all unused cards were located, and no evidence of tampering with the silver panel was found.ConclusionParamedics can use scratchcards as a method of randomly allocating patients in trials in prehospital care. In the future, a method that allows only the top card to be selected and a more protective method of storing the cards should be used. Scratchcards can be considered for wider use in RCTs in the emergency prehospital setting.Trial registration numberISRCTN60065373; Post-results.

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Convalescent plasma for treatment of COVID-19: study protocol for an open randomised controlled trial in Sweden

BMJ Open ◽

10.1136/bmjopen-2020-048337 ◽

2021 ◽

Vol 11 (12) ◽

pp. e048337

Author(s):

Joakim Dillner ◽

Johan Ursing

Keyword(s):

Randomised Controlled Trial ◽

Standard Care ◽

Controlled Trial ◽

Ethical Review ◽

Block Randomisation ◽

Ethical Approval ◽

Registration Number ◽

Secondary Endpoints ◽

Randomised Controlled ◽

Antibody Levels

IntroductionAlthough there are many studies on the use of convalescent plasma (CP) for treatment of COVID-19, it is not clear (1) which groups of patients may benefit, (2) what dose of plasma to give, or (3) which antibody levels the plasma should contain. Previous phase I/II studies and literature review suggest that CP should only be given to patients with viraemia, that a daily infusion should be given until the patient becomes virus free and that the neutralising antibody titre should preferably be >1:640Methods and analysisAn open randomised controlled trial enrolling patients with COVID-19, who must be SARS-CoV-2 positive in both airway and blood samples and admitted to a study hospital. Block randomisation 2:1 is to either 200 mL CP (preferably titre ≥1/640) daily for up to 10 days (until virus negative in blood) plus standard care or standard care only (control arm). The primary endpoint is mortality by day 28 after study inclusion. Secondary endpoints include mortality by day 60 and doses of plasma needed to clear viraemia. Assuming a reduced mortality of approximately 30% by the CP therapy and 85%–88% survival in the control arm, approximately 600 participants will be enrolled to the CP therapy arm and 300 participants to the control arm.Ethics and disseminationEthical approval has been granted by the Swedish Ethical Review Authority (reference: 2020-06277). Results from this trial will be compiled in a clinical study report, disseminated via journal articles and communicated to stakeholders.Trial registration numberNCT04649879.

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