Tenofovir alafenamide fumarate therapy in subjects with positive HBV-DNA and normal levels of alanine transaminase: a study protocol for a randomised controlled trial

IntroductionThe current clinical guidelines do not recommend antiviral therapy for subjects with positive hepatitis B virus (HBV)-DNA and normal alanine transaminase (ALT). In this study, we will assess the safety and efficacy of tenofovir alafenamide fumarate (TAF) in the treatment of adults with positive HBV-DNA and normal ALT, including long-term prognosis.Methods and analysisThis study is a non-double-blind randomised controlled trial. Study participants will be randomised into the treatment group and the control group. In the treatment group, subjects will receive TAF monotherapy, while those in the control group will receive no antiviral treatment. Subjects will be followed up at the beginning of the study and every 12 or 24 weeks thereafter for review of laboratory findings and to record adverse events. The primary endpoint is the proportion of patients with serum hepatitis B surface antigen loss.Ethics and disseminationThis study protocol was approved by the Ethics Committee of the Third Affiliated Hospital of Sun Yat-Sen University for Human Study (reference number [2019]02-599-01). The results of this study will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT04231565.

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Community-based doula support for migrant women during labour and birth: study protocol for a randomised controlled trial in Stockholm, Sweden (NCT03461640)

BMJ Open ◽

10.1136/bmjopen-2019-031290 ◽

2020 ◽

Vol 10 (2) ◽

pp. e031290

Author(s):

Erica Schytt ◽

Anna Wahlberg ◽

Amani Eltayb ◽

Rhonda Small ◽

Nataliia Tsekhmestruk ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Study Protocol ◽

Controlled Trial ◽

Well Being ◽

Ethical Review ◽

Control Group ◽

Migrant Women ◽

Intrapartum Care ◽

Community Based ◽

Randomised Controlled

IntroductionMigrant women consistently rate their care during labour and birth more negatively than non-migrant women, due to communication difficulties, lack of familiarity with how care is provided, and discrimination and prejudicial staff attitudes. They also report being left alone, feeling fearful, unsafe and unsupported, and have poorer birth outcomes than non-migrant women. Community-based doulas (CBDs) are bilingual women from migrant communities who are trained in childbirth and labour support, and who facilitate communication between woman-partner-staff during childbirth. This study protocol describes the design, rationale and methods of a randomised controlled trial that aims to evaluate the effectiveness of CBD support for improving the intrapartum care experiences and postnatal well-being of migrant women giving birth in Sweden.Methods and analysisA randomised controlled trial. From six antenatal care clinics in Stockholm, Sweden, we aim to recruit 200 pregnant Somali, Arabic, Polish, Russian and Tigrinya-speaking women who cannot communicate fluently in Swedish, are 18 years or older and with no contraindications for vaginal birth. In addition to standard labour support, women are randomised to CBD support (n=100) or no such support during labour (n=100). Trained CBDs meet with women once or twice before the birth, provide emotional, physical and communication support to women throughout labour and birth in hospital, and then meet with women once or twice after the birth. Women’s ratings of the intrapartum care experiences and postnatal well-being are assessed at 6–8 weeks after the birth using selected questions from the Migrant Friendly Maternity Care Questionnaire and by the Edinburgh Postnatal Depression Scale. The intervention group will be compared with the control group using intention-to-treat analyses. ORs and 95% CIs will be estimated and adjustments made if key participant characteristics differ between trial arms.Ethics and disseminationThe study was approved by the Regional Ethical Review Board in Stockholm (approval number: 2018/12 - 31/2).Trial registration numberNCT03461640; Pre-results.

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Mindfulness-based and cognitive-based stress prevention in student teachers (startklar): study protocol of a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2018-021941 ◽

2019 ◽

Vol 9 (2) ◽

pp. e021941

Author(s):

Jasmina Eskic ◽

Sophie Merle Kuhlmann ◽

Katharina Kreinbihl ◽

Florian Hammerle

Keyword(s):

Randomised Controlled Trial ◽

Student Teachers ◽

Study Protocol ◽

Controlled Trial ◽

Control Group ◽

High Risk Population ◽

Stress Prevention ◽

Positive Effects ◽

Randomised Controlled

IntroductionTeachers and student teachers in Germany are a high-risk population for stress and stress-related mental health problems. This often leads to early retirement in subsequent professional life. Various trials have demonstrated positive effects of stress prevention training on the perceived stress and stress-related symptoms of teachers. Although many studies show positive effects of mindfulness-based stress interventions, there is not yet any mindfulness-based intervention for teachers or student teachers in Germany. The aim of this trial is to evaluate a training that combines mindfulness-based and cognitive interventions into one programme, addressing to the specific burdens of student teachers.Methods and analysisThis study protocol presents a prospective block-randomised controlled trial. Assessment will take place at three time points (baseline, post-intervention, 3-month follow-up) for an intervention and waiting control group, and at a fourth assessment point for the waiting control group after receiving the training. The aim is to evaluate the effects of mindfulness-based stress prevention on stress, psychological morbidity, burnout and self-efficacy using validated measures. Participants are student teachers from German teacher training colleges and participation will be voluntary. The targeted total sample size is 96 at 3-month follow-up. The training will comprise three 4-hour sessions conducted every 2 weeks. The control group will participate in the training after the 3-month follow-up. The allotment will be randomised with a stratified allocation ratio by gender. After descriptive statistics have been evaluated, inferential statistical analysis will be conducted using repeated measures analysis of variance with interactions between time and group. Effect sizes will be calculated using partial η2values.Ethics and disseminationResults will be disseminated at conferences, in specialist magazines and through peer-reviewed publications. The trial has been approved by the ethics review board of the local medical association, Mainz, Germany, under the reference number 837.192.16 (10511).Trial registration numberDRKS00010897.

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Robotic-based ACTive somatoSENSory (Act.Sens) retraining on upper limb functions with chronic stroke survivors: study protocol for a pilot randomised controlled trial

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00948-3 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Ananda Sidarta ◽

Yu Chin Lim ◽

Christopher Wee Keong Kuah ◽

Yong Joo Loh ◽

Wei Tech Ang

Keyword(s):

Randomised Controlled Trial ◽

Study Protocol ◽

Upper Limb ◽

Controlled Trial ◽

Chronic Stroke ◽

Community Dwelling ◽

Control Group ◽

Stroke Survivors ◽

Pilot Randomised Controlled Trial ◽

Randomised Controlled

Abstract Background Prior studies have established that senses of the limb position in space (proprioception and kinaesthesia) are important for motor control and learning. Although nearly one-half of stroke patients have impairment in the ability to sense their movements, somatosensory retraining focusing on proprioception and kinaesthesia is often overlooked. Interventions that simultaneously target motor and somatosensory components are thought to be useful for relearning somatosensory functions while increasing mobility of the affected limb. For over a decade, robotic technology has been incorporated in stroke rehabilitation for more controlled therapy intensity, duration, and frequency. This pilot randomised controlled trial introduces a compact robotic-based upper-limb reaching task that retrains proprioception and kinaesthesia concurrently. Methods Thirty first-ever chronic stroke survivors (> 6-month post-stroke) will be randomly assigned to either a treatment or a control group. Over a 5-week period, the treatment group will receive 15 training sessions for about an hour per session. Robot-generated haptic guidance will be provided along the movement path as somatosensory cues while moving. Audio-visual feedback will appear following every successful movement as a reward. For the same duration, the control group will complete similar robotic training but without the vision occluded and robot-generated cues. Baseline, post-day 1, and post-day 30 assessments will be performed, where the last two sessions will be conducted after the last training session. Robotic-based performance indices and clinical assessments of upper limb functions after stroke will be used to acquire primary and secondary outcome measures respectively. This work will provide insights into the feasibility of such robot-assisted training clinically. Discussion The current work presents a study protocol to retrain upper-limb somatosensory and motor functions using robot-based rehabilitation for community-dwelling stroke survivors. The training promotes active use of the affected arm while at the same time enhances somatosensory input through augmented feedback. The outcomes of this study will provide preliminary data and help inform the clinicians on the feasibility and practicality of the proposed exercise. Trial registration ClinicalTrials.gov NCT04490655. Registered 29 July 2020.

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Clinical effects of high-intensity laser therapy on patients with chronic refractory wounds: a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-045866 ◽

2021 ◽

Vol 11 (7) ◽

pp. e045866

Author(s):

Qian Lu ◽

Zhifei Yin ◽

Xuefeng Shen ◽

Jinhua Li ◽

Panpan Su ◽

...

Keyword(s):

Treatment Group ◽

Randomised Controlled Trial ◽

High Intensity ◽

Wound Dressing ◽

Wound Care ◽

Controlled Trial ◽

Control Group ◽

High Intensity Laser ◽

Randomised Controlled ◽

Intensity Laser

ObjectiveTo investigate the effectiveness of high-intensity laser therapy (HILT) on chronic refractory wounds.DesignRandomised controlled trial.SettingThe outpatient wound care department of the Affiliated Jiangsu Shengze Hospital of Nanjing Medical University from August 2019 to June 2020.ParticipantsSixty patients were enrolled in this study and were randomised into control (n=30) and treatment (n=30) groups.Interventions and outcome measuresThe control group was treated only with conventional wound dressing, whereas the treatment group received irradiation with HILT in addition to standard wound care, such as debridement, wound irrigation with normal saline solution and application of dressing and sterile gauze. Patient scores on the Bates-Jensen Wound Assessment Tool (BWAT) and Pressure Ulcer Scale for Healing (PUSH) were evaluated before and after 1, 2 and 3 weeks of treatment.ResultsOne patient was excluded from the control group, and a total of 59 subjects completed the trial. The BWAT scores significantly decreased in the treatment group compared with the control group at the end of 3-week treatment (difference=−3.6; 95% CI −6.3 to–0.8; p<0.01). Similarly, patients in treatment group showed a significant reduction of PUSH scores compared with the control group (difference=−5.3; 95% CI −8.1 to –2.6; p<0.01).ConclusionsThe therapeutic effects of HILT on chronic refractory wounds are significant and far more superior to those of conventional wound dressing.Trial registration numberChinese Clinical Trial Registry; ChiCTR1900023157. URL: http://www.chictr.org.cn/showproj.aspx?proj=38866

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Hyperbaric oxygen as an adjuvant treatment for patients with COVID-19 severe hypoxaemia: a randomised controlled trial

Emergency Medicine Journal ◽

10.1136/emermed-2021-211253 ◽

2021 ◽

pp. emermed-2021-211253

Author(s):

Mariana Cannellotto ◽

Mariano Duarte ◽

Guillermo Keller ◽

Ramiro Larrea ◽

Eleonora Cunto ◽

...

Keyword(s):

Acute Respiratory Distress Syndrome ◽

Treatment Group ◽

Randomised Controlled Trial ◽

Interim Analysis ◽

Distress Syndrome ◽

Controlled Trial ◽

Control Group ◽

Safety And Efficacy ◽

Severe Hypoxaemia ◽

Randomised Controlled

BackgroundHyperbaric oxygen (HBO2) therapy has been proposed to treat hypoxaemia and reduce inflammation in COVID-19. Our objective was to analyse safety and efficacy of HBO2 in treatment of hypoxaemia in patients with COVID-19 and evaluate time to hypoxaemia correction.MethodsThis was a multicentre, open-label randomised controlled trial conducted in Buenos Aires, Argentina, between July and November 2020. Patients with COVID-19 and severe hypoxaemia (SpO2 ≤90% despite oxygen supplementation) were assigned to receive either HBO2 treatment or the standard treatment for respiratory symptoms for 7 days. HBO2 treatment was planned for ≥5 sessions (1 /day) for 90 min at 1.45 atmosphere absolute (ATA). Outcomes were time to normalise oxygen requirement to SpO2 ≥93%, need for mechanical respiratory assistance, development of acute respiratory distress syndrome and mortality within 30 days. A sample size of 80 patients was estimated, with a planned interim analysis after determining outcomes on 50% of patients.ResultsThe trial was stopped after the interim analysis. 40 patients were randomised, 20 in each group, age was 55.2±9.2 years. At admission, frequent symptoms were dyspnoea, fever and odynophagia; SpO2 was 85.1%±4.3% for the whole group. Patients in the treatment group received an average of 6.2±1.2 HBO2 sessions. Time to correct hypoxaemia was shorter in treatment group versus control group; median 3 days (IQR 1.0–4.5) versus median 9 days (IQR 5.5–12.5), respectively (p<0.010). OR for recovery from hypoxaemia in the HBO2 group at day 3 compared with the control group was 23.2 (95% CI 1.6 to 329.6; p=0.001) Treatment had no statistically significant effect on acute respiratory distress syndrome, mechanical ventilation or death within 30 days after admission.ConclusionOur findings support the safety and efficacy of HBO2 in the treatment of COVID-19 and severe hypoxaemia.Trial registration numberNCT04477954.

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Effectiveness of breathing exercises, foot reflexology and back massage (BRM) on labour pain, anxiety, duration, satisfaction, stress hormones and newborn outcomes among primigravidae during the first stage of labour in Saudi Arabia: a study protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-033844 ◽

2020 ◽

Vol 10 (6) ◽

pp. e033844

Author(s):

Kamilya Jamel Baljon ◽

Muhammad Hibatullah Romli ◽

Adibah Hanim Ismail ◽

Lee Khuan ◽

Boon How Chew

Keyword(s):

Saudi Arabia ◽

Randomised Controlled Trial ◽

Sample Size ◽

Study Protocol ◽

Human Subjects ◽

Controlled Trial ◽

Labour Pain ◽

Control Group ◽

Breathing Exercises ◽

Randomised Controlled

IntroductionLabour pain is among the severest pains primigravidae may experience during pregnancy. Failure to address labour pain and anxiety may lead to abnormal labour. Despite the many complementary non-pharmacological approaches to coping with labour pain, the quality of evidence is low and best approaches are not established. This study protocol describes a proposed investigation of the effects of a combination of breathing exercises, foot reflexology and back massage (BRM) on the labour experiences of primigravidae.Methods and analysisThis randomised controlled trial will involve an intervention group receiving BRM and standard labour care, and a control group receiving only standard labour care. Primigravidae of 26–34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal clinics. Eligible and consenting patients will be randomly allocated to the intervention or the control group stratified by intramuscular pethidine use. The BRM intervention will be delivered by a trained massage therapist. The primary outcomes of labour pain and anxiety will be measured during and after uterine contractions at baseline (cervical dilatation 6 cm) and post BRM hourly for 2 hours. The secondary outcomes include maternal stress hormone (adrenocorticotropic hormone, cortisol and oxytocin) levels, maternal vital signs (V/S), fetal heart rate, labour duration, Apgar scores and maternal satisfaction. The sample size is estimated based on the between-group difference of 0.6 in anxiety scores, 95% power and 5% α error, which yields a required sample size of 154 (77 in each group) accounting for a 20% attrition rate. The between-group and within-group outcome measures will be examined with mixed-effect regression models, time series analyses and paired t-test or equivalent non-parametric tests, respectively.Ethics and disseminationEthical approval was obtained from the Ethical Committee for Research Involving Human Subjects of the Ministry of Health in the Saudi Arabia (H-02-K-076-0319-109) on 14 April 2019, and from the Ethics Committee for Research Involving Human Subjects (JKEUPM) Universiti Putra Malaysia on 23 October 2019, reference number: JKEUPM-2019–169. Written informed consent will be obtained from all participants. Results from this trial will be presented at regional, national and international conferences and published in indexed journals.Trial registration numberISRCTN87414969, registered 3 May 2019.

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Cognitive–behavioural group therapy for adolescents with ADHD: study protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-032839 ◽

2020 ◽

Vol 10 (3) ◽

pp. e032839 ◽

Cited By ~ 1

Author(s):

Torunn Stene Nøvik ◽

Anne-Lise Juul Haugan ◽

Stian Lydersen ◽

Per Hove Thomsen ◽

Susan Young ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Group Therapy ◽

Study Protocol ◽

Rating Scale ◽

Controlled Trial ◽

Control Group ◽

Treatment As Usual ◽

Cognitive Behavioural ◽

Child Psychiatric ◽

Randomised Controlled

IntroductionPersistence of attention deficit hyperactivity disorder (ADHD) into adolescence is a significant burden to patients. Clinical guidelines recommend non-pharmacological therapies, but the evidence to support this recommendation is sparse. This study aims to evaluate the effect of a 12-week group cognitive–behavioural therapy (CBT) programme for adolescents with ADHD aged 14–18 years, who still have impairing symptoms after treatment with medication. We will study the effect of the treatment on ADHD symptoms and examine moderators and mediators of the effect of the treatment on ADHD.Methods and analysisWe conduct a randomised controlled trial of CBT group therapy in adolescents with ADHD recruited from child psychiatric outpatient units in Mid-Norway. 99 adolescents who met inclusion criteria and consented to participation have been randomised to a 12-week group intervention or to a control group receiving treatment as usual. Assessments are made at admission to the clinic, preintervention, postintervention and at a 9-month follow-up, obtaining adolescent, parent and teacher reports. Clinicians blinded to group allocation rate all participants as to their functioning preintervention and at the two postintervention assessment points. The primary outcome is change in symptom scores on the ADHD Rating Scale-IV.Ethics and disseminationThe Regional Committee for Medical and Health Research Ethics in South East Norway approved the study protocol (2015/2115). We will disseminate the findings in peer-reviewed publications and conference presentations, to user organisations and at courses attended by families and professionals. Two PhD students will publish and defend dissertations relating to the study. Planned publications include primary and secondary outcomes and patient satisfaction with the treatment. Furthermore, we plan to publish a manual of CBT group therapy in adolescent ADHD to benefit treatment of patients in Norway and elsewhere.Trial registration numberNCT02937142

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Brief mindfulness-based intervention of ‘STOP (Stop, Take a Breath, Observe, Proceed) touching your face’: a study protocol of a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-041364 ◽

2020 ◽

Vol 10 (11) ◽

pp. e041364

Author(s):

Yanhui Liao ◽

Ling Wang ◽

Tao Luo ◽

Shiyou Wu ◽

Zhenzhen Wu ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Study Protocol ◽

Controlled Trial ◽

Intervention Group ◽

Analysis Of Covariance ◽

Control Group ◽

Psychological Traits ◽

Study Results ◽

Before And After ◽

Randomised Controlled

IntroductionFace-touching behaviour often happens frequently and automatically, and poses potential risk for spreading infectious disease. Mindfulness-based interventions (MBIs) have shown its efficacy in the treatment of behaviour disorders. This study aims to evaluate an online mindfulness-based brief intervention skill named ‘STOP (Stop, Take a Breath, Observe, Proceed) touching your face’ in reducing face-touching behaviour.Methods and analysisThis will be an online-based, randomised, controlled, trial. We will recruit 1000 participants, and will randomise and allocate participants 1:1 to the ‘STOP touching your face’ (both 750-word text and 5 min audio description by online) intervention group (n=500) and the wait-list control group (n=500). All participants will be asked to monitor and record their face-touching behaviour during a 60 min period before and after the intervention. Primary outcome will be the efficacy of short-term mindfulness-based ‘STOP touching your face’ intervention for reducing the frequency of face-touching. The secondary outcomes will be percentage of participants touching their faces; the correlation between the psychological traits of mindfulness and face-touching behaviour; and the differences of face-touching behaviour between left-handers and right-handers. Analysis of covariance, regression analysis, χ2 test, t-test, Pearson’s correlations will be applied in data analysis. We will recruit 1000 participants from April to July 2020 or until the recruitment process is complete. The follow-up will be completed in July 2020. We expect all trial results to be available by the end of July 2020.Ethics and disseminationThe study protocol has been approved by the Ethics Committee of Sir Run Run Shaw Hospital, an affiliate of Zhejiang University, Medical College (No. 20200401-32). Study results will be disseminated via social media and peer-reviewed publications.Trial registration numberNCT04330352.

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Randomised controlled trial of tetanus treatment with antitetanus immunoglobulin by the intrathecal or intramuscular route

BMJ ◽

10.1136/bmj.38027.560347.7c ◽

2004 ◽

Vol 328 (7440) ◽

pp. 615 ◽

Cited By ~ 58

Author(s):

Demócrito de Barros Miranda-Filho ◽

Ricardo Arraes de Alencar Ximenes ◽

Antônio Alci Barone ◽

Vicente Luiz Vaz ◽

Aderbal Gomes Vieira ◽

...

Keyword(s):

Treatment Group ◽

Randomised Controlled Trial ◽

Hospital Stay ◽

Controlled Trial ◽

Control Group ◽

Clinical Progression ◽

Intramuscular Route ◽

Mechanical Ventilation Duration ◽

Randomised Controlled ◽

Respiratory Assistance

AbstractObjective To evaluate the effect of intrathecal therapy with human antitetanus immunoglobulin on clinical progression of and mortality from tetanus.Design Randomised controlled trial.Setting Intensive care unit of a university hospital, Pernambuco, Brazil.Participants 120 patients with tetanus allocated to antitetanus immunoglobulin by either the intrathecal and intramuscular route (n = 58) or the intramuscular route (n = 62; control group).Main outcome measures Clinical progression of disease, duration of hospital stay, duration of occurrence of spasms, complications, respiratory infection, respiratory failure or mechanical ventilation, duration of respiratory assistance, and mortality.Results Patients in the treatment group showed a better clinical progression than those in the control group (χ2 for trend 7.752, P = 0.005; difference in proportion of patients with improvement 20%, 95% confidence interval 4% to 35%). The duration of occurrence of spasms, hospital stay, and respiratory assistance were all shorter in patients the treatment group: respectively, 14.96, 0.0001 (difference in proportion of patients with spasms lasting ≤ 10 days 36%, 18% to 55%); 4.56, 0.03; and 6.56, 0.01 (proportion of patients who needed assistance for ≤ 10 days 69.2% in the treatment group and 30.8% in the control group (difference 38%, 12% to 65%)).Conclusion Patients treated with antitetanus immunoglobulin by the intrathecal route show better clinical progression than those treated by the intramuscular route.

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Diet and anthropometry at 2 years of age following an oral health promotion programme for Australian Aboriginal children and their carers: a randomised controlled trial

British Journal Of Nutrition ◽

10.1017/s000711451700318x ◽

2017 ◽

Vol 118 (12) ◽

pp. 1061-1069 ◽

Cited By ~ 5

Author(s):

Lisa G. Smithers ◽

John Lynch ◽

Joanne Hedges ◽

Lisa M. Jamieson

Keyword(s):

Health Promotion ◽

Oral Health ◽

Treatment Group ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Control Group ◽

Culturally Appropriate ◽

Oral Health Promotion ◽

Randomised Controlled ◽

Aboriginal Children

AbstractThere are marked disparities between indigenous and non-indigenous children’s diets and oral health. Both diet and oral health are linked to longer-term health problems. We aimed to investigate whether a culturally appropriate multi-faceted oral health promotion intervention reduced Aboriginal children’s intake of sugars from discretionary foods at 2 years of age. We conducted a single-blind, parallel-arm randomised controlled trial involving women who were pregnant or had given birth to an Aboriginal child in the previous 6 weeks. The treatment group received anticipatory guidance, Motivational Interviewing, health and dental care for mothers during pregnancy and children at 6, 12 and 18 months. The control group received usual care. The key dietary outcome was the percent energy intake from sugars in discretionary foods (%EI), collected from up to three 24-h dietary recalls by trained research officers who were blind to intervention group. Secondary outcomes included intake of macronutrients, food groups, anthropometric z scores (weight, height, BMI and mid-upper arm circumference) and blood pressure. We enrolled 224 children to the treatment group and 230 to the control group. Intention-to-treat analyses showed that the %EI of sugars in discretionary foods was 1·6 % lower in the treatment group compared with control (95 % CI −3·4, 0·2). This culturally appropriate intervention at four time-points from pregnancy to 18 months resulted in small changes to 2-year-old Aboriginal children’s diets, which was insufficient to warrant broader implementation of the intervention. Further consultation with Aboriginal communities is necessary for understanding how to improve the diet and diet-related health outcomes of young Aboriginal children.

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