scholarly journals Treatment with the anti-IgE monoclonal antibody omalizumab in women with asthma undergoing fertility treatment: a proof-of-concept study—The PRO-ART study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e037041
Author(s):  
Casper Tidemandsen ◽  
Elisabeth Juul Gade ◽  
Charlotte Suppli Ulrik ◽  
Henriette Svarre Nielsen ◽  
Birgitte Sophie Oxlund-Mariegaard ◽  
...  
Keyword(s):  
Pregnancy Rate ◽  
Perinatal Death ◽  
Controlled Trial ◽  
Reproductive Organs ◽  
Ethics Committee ◽  
Fertility Treatment ◽  
Blood Eosinophil ◽  
Eosinophil Cell ◽  
The Difference ◽  
Randomised Controlled

IntroductionAsthma is associated with prolonged time to pregnancy and a higher need for fertility treatment. However, the mechanism underlying this association remains incompletely understood. Previous research points to asthma-driven systemic inflammation also affecting the reproductive organs and thereby fertility. The aim of this study was to determine if treatment with omalizumab prior to fertility treatment will increase pregnancy rate among women with asthma by decreasing the systemic asthma-related inflammation and, by that, to provide insight into the underlying mechanisms.Methods and analysisThis is an ongoing prospective multicentre randomised controlled trial planned to enrol 180 women with asthma recruited from fertility clinics in Denmark. The patients are randomised 1:1 to either omalizumab or placebo. The primary endpoint is the difference in pregnancy rate confirmed with ultrasound at gestational week 7 of pregnancy. The secondary endpoints are change in sputum and blood eosinophil cell count, change in biomarkers, change in microbiota, together with rate of pregnancy loss, frequency of malformations, pre-eclampsia, preterm birth, birth weight, small for gestational age and perinatal death between groups.Ethics and disseminationThe methods used in this study are of low risk, but if successful, our findings will have a large impact on a large group of patients as infertility and asthma are the most common chronic diseases among the young population. The study has been approved by the Ethics Committee–Danish national research ethics committee (H-18016605) and the Danish Medicines Agency (EudraCT no: 2018-001137-41) and the Danish Data Protection Agency (journal number: VD-2018486 and I-Suite number 6745). The test results will be published regardless of whether they are positive, negative or inconclusive. Publication in international peer-reviewed scientific journals is planned.Trial registration numberNCT03727971.

scholarly journals Anti-adhesion Gel versus No gel following Operative Hysteroscopy prior to Subsequent fertility Treatment or timed InterCourse (AGNOHSTIC), a randomised controlled trial: protocol

2021 ◽  
Vol 2021 (1) ◽  
Author(s):  
S van Wessel ◽  
T Hamerlynck ◽  
V Schutyser ◽  
C Tomassetti ◽  
C Wyns ◽  
...  
Keyword(s):  
Live Birth ◽  
Financial Support ◽  
Controlled Trial ◽  
Reproductive Age ◽  
Fertility Treatment ◽  
Control Group ◽  
Women Of Reproductive Age ◽  
Operative Hysteroscopy ◽  
Randomised Controlled

Abstract STUDY QUESTIONS Does the application of anti-adhesion gel, compared to no gel, following operative hysteroscopy to treat intrauterine pathology in women wishing to conceive increase the chance of conception leading to live birth? WHAT IS KNOWN ALREADY Intrauterine adhesions (IUAs) following operative hysteroscopy may impair reproductive success in women of reproductive age. Anti-adhesion barrier gels may decrease the occurrence of IUAs, but the evidence on their effectiveness to improve reproductive outcomes is sparse and of low quality. STUDY DESIGN, SIZE, DURATION This multicentre, parallel group, superiority, blinded and pragmatic randomised controlled trial is being carried out in seven participating centres in Belgium. Recruitment started in April 2019. Women will be randomly allocated to treatment with anti-adhesion gel (intervention group) or no gel (control group). Sterile ultrasound gel will be applied into the vagina as a mock-procedure in both treatment arms. The patient, fertility physician and gynaecologist performing the second-look hysteroscopy are unaware of the allocated treatment. Power analysis, based on a target improvement of 15% in conception leading to live birth using anti-adhesion gel, a power of 85%, a significance level of 5%, and a drop-out rate of 10%, yielded a number of 444 patients to be randomised. The baseline rate of conception leading to live birth in the control group is expected to be 45%. PARTICIPANTS/MATERIALS, SETTING, METHODS Women of reproductive age (18–47 years), wishing to conceive (spontaneously or by fertility treatment) and scheduled for operative hysteroscopy to treat intrauterine pathology (endometrial polyps, myomas with uterine cavity deformation, uterine septa, IUAs or retained products of conception) are eligible for recruitment. Women may try to conceive from 3 to 6 weeks after receiving allocated treatment with follow-up ending at 30 weeks after treatment. If the woman fails to conceive within this timeframe, a second-look hysteroscopy will be scheduled within 2–6 weeks to check for IUAs. The primary endpoint is conception leading to live birth, measured at 30 weeks after randomisation. The secondary endpoints are time to conception, clinical pregnancy, miscarriage and ectopic pregnancy rates, measured at 30 weeks after receiving allocated treatment. The long-term follow-up starts when the patient is pregnant and she will be contacted every trimester. STUDY FUNDING/COMPETING INTEREST(S) This work is funded by the Belgian Healthcare Knowledge Centre (KCE). The anti-adhesion gel is supplied at no cost by Nordic Pharma and without conditions. Dr. Tomassetti reports grants and non-financial support from Merck SA, non-financial support from Ferring SA, personal fees and non-financial support from Gedeon-Richter, outside the submitted work. None of the other authors have a conflict of interest.

scholarly journals How well do doctors understand a scientific article in English when it is not their first language? A randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e043444
Author(s):  
Martine Rostadmo ◽  
Siri Lunde Strømme ◽  
Magne Nylenna ◽  
Pal Gulbrandsen ◽  
Erlend Hem ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
First Language ◽  
Review Article ◽  
Scientific Article ◽  
Potential Range ◽  
Parallel Group ◽  
The Difference ◽  
Randomised Controlled ◽  
Primary Care Medicine

IntroductionEnglish is the lingua franca of science. How well doctors understand English is therefore crucial for their understanding of scientific articles. However, only 5% of the world’s population have English as their first language.MethodsObjectives: To compare doctors’ comprehension of a scientific article when read in their first language (Norwegian) versus their second language (English). Our hypothesis was that doctors reading the article in Norwegian would comprehend the content better than those reading it in English.Design: Parallel group randomised controlled trial. We randomised doctors to read the same clinical review article in either Norwegian or English, before completing a questionnaire about the content of the article.Setting: Conference in primary care medicine in Norway, 2018.Participants: 130 native Norwegian-speaking doctors, 71 women and 59 men. One participant withdrew before responding to the questionnaire and was excluded from the analyses.Interventions: Participants were randomly assigned to read a review article in either Norwegian (n=64) or English (n=66). Reading time was limited to 7 min followed by 7 min to answer a questionnaire.Main outcome measures: Total score on questions related to the article content (potential range −9 to 20).ResultsDoctors who read the article in Norwegian had a mean total score of 10.40 (SD 3.96) compared with 9.08 (SD 3.47) among doctors who read the article in English, giving a mean difference of 1.32 (95% CI 0.03 to 2.62; p=0.046). Age was independently associated with total score, with decreased comprehension with increasing age.ConclusionThe difference in comprehension between the group who read in Norwegian and the group who read in English was statistically significant but modest, suggesting that the language gap in academia is possible to overcome.

scholarly journals Effects of training on quality of peer review: randomised controlled trial

BMJ ◽  
2004 ◽  
Vol 328 (7441) ◽  
pp. 673 ◽  
Author(s):  
Sara Schroter ◽  
Nick Black ◽  
Stephen Evans ◽  
James Carpenter ◽  
Fiona Godlee ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Peer Review ◽  
Controlled Trial ◽  
Control Group ◽  
Group Score ◽  
The Difference ◽  
Randomised Controlled ◽  
Quality Instrument

AbstractObjective To determine the effects of training on the quality of peer review.Design Single blind randomised controlled trial with two intervention groups receiving different types of training plus a control group.Setting and participants Reviewers at a general medical journal.Interventions Attendance at a training workshop or reception of a self taught training package focusing on what editors want from reviewers and how to critically appraise randomised controlled trials.Main outcome measures Quality of reviews of three manuscripts sent to reviewers at four to six monthly intervals, evaluated using the validated review quality instrument; number of deliberate major errors identified; time taken to review the manuscripts; proportion recommending rejection of the manuscripts.Results Reviewers in the self taught group scored higher in review quality after training than did the control group (score 2.85 v 2.56; difference 0.29, 95% confidence interval 0.14 to 0.44; P = 0.001), but the difference was not of editorial significance and was not maintained in the long term. Both intervention groups identified significantly more major errors after training than did the control group (3.14 and 2.96 v 2.13; P < 0.001), and this remained significant after the reviewers' performance at baseline assessment was taken into account. The evidence for benefit of training was no longer apparent on further testing six months after the interventions. Training had no impact on the time taken to review the papers but was associated with an increased likelihood of recommending rejection (92% and 84% v 76%; P = 0.002).Conclusions Short training packages have only a slight impact on the quality of peer review. The value of longer interventions needs to be assessed.

scholarly journals Effectiveness and cost of integrating a pragmatic pathway for prescribing liraglutide 3.0 mg in obesity services (STRIVE study): study protocol of an open-label, real-world, randomised, controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034137 ◽  
Author(s):  
Dimitris Papamargaritis ◽  
Werd Al-Najim ◽  
Jonathan Lim ◽  
James Crane ◽  
Mike Lean ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Research Ethics ◽  
Real World ◽  
Regulatory Authority ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Stopping Rules ◽  
Open Label ◽  
Randomised Controlled

IntroductionIn the UK and Ireland, severe and complex obesity is managed in specialist weight management services (SWMS), which provide multicomponent lifestyle interventions to support weight loss, and use of medication if available. Liraglutide 3 mg (LIRA 3 mg) is an effective weight-loss medication, but weight loss in individual patients is variable, and its efficacy has not been assessed in SWMS. This study aims to investigate whether a targeted prescribing pathway for LIRA 3 mg with multiple prespecified stopping rules could help people with severe obesity and established complications achieve ≥15% weight loss in order to determine whether this could be considered a clinically effective and cost-effective strategy for managing severe and complex obesity in SWMS.Methods and analysisIn this 2-year, multicentre, open-label, real-world randomised controlled trial, 384 adults with severe and complex obesity (defined as body mass index ≥35 kg/m2plus either prediabetes, type 2 diabetes, hypertension or sleep apnoea) will be randomised via a 2:1 ratio to receive either standard SWMS care (n=128) or standard SWMS care plus a targeted prescribing pathway for LIRA 3 mg with prespecified stopping rules at 16, 32 and 52 weeks (n=256).The primary outcome is to compare the proportion of participants achieving a weight loss of ≥15% at 52 weeks with a targeted prescribing pathway versus standard care. Secondary outcomes include a comparison of (1) the weight loss maintenance at 104 weeks and (2) the budget impact and cost effectiveness between the two groups in a real-world setting.Ethics and disseminationThe Health Research Authority and the Medicines and Healthcare products Regulatory Authority in UK, the Health Products Regulatory Authority in Ireland, the North West Deanery Research Ethics Committee (UK) and the St Vincent’s University Hospital European Research Ethics Committee (Ireland) have approved the study. The findings of the study will be published in peer-reviewed journals.Trial registration numberClinicalTrials.gov—Identifier:NCT03036800.European Clinical Trials Database—Identifier: EudraCT Number 2017-002998-20.

Plasma Nesfatin-1 Level in Obese Patients after Acupuncture: A Randomised Controlled Trial

2014 ◽  
Vol 32 (4) ◽  
pp. 313-317 ◽  
Author(s):  
Yongfang Guo ◽  
Mingqing Xing ◽  
Wenjuan Sun ◽  
Xiaoyan Yuan ◽  
Hongyan Dai ◽  
...  
Keyword(s):  
Weight Control ◽  
Serum Insulin ◽  
Controlled Trial ◽  
Diet Group ◽  
Normal Weight ◽  
Obese Patients ◽  
Obese Adults ◽  
The Difference ◽  
Randomised Controlled ◽  
The Relationship

Background Nesfatin-1 is an anorexigenic hormone suggested to regulate obesity. Objective To investigate the relationship between nesfatin-1 level and anthropometric and metabolic parameters in obese patients, and examine the change in plasma nesfatin-1 level after acupuncture treatment. Methods 64 obese adult patients without diabetes and 58 normal weight control subjects were enrolled in this study. The obese patients were randomly divided into an acupuncture plus diet group (n=32) and a diet only group (n=32). Measurements were repeated after 45 days. Results Body mass index (BMI), waist and hip circumferences, serum insulin, lipoprotein and insulin resistance measures were significantly higher, and plasma nesfatin-1 level was significantly lower, in obese patients than in normal weight controls. In addition, negative correlations were found between plasma nesfatin-1 level and BMI, waist and hip circumferences. Weight reduction in participants after acupuncture and diet restriction was 7.0% and 4.3%, respectively. Plasma nesfatin-1 level increased from 2.75±1.16 to 3.44±1.28 ng/mL and from 2.86±1.07 to 3.23±1.06 ng/mL in acupuncture and diet groups, respectively; the difference was significant, p<0.05. Conclusions Plasma nesfatin-1 level is reduced in obese adults, and is increased after acupuncture. The beneficial effect of acupuncture on obesity is associated with increased plasma nesfatin-1 level.

126 A Student Pilot for A Feasibility Study of the Theoretical 3S Trial (SPFT3S): GP and Ethics Committee Members Questionnaire

2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i12-i42
Author(s):  
L Brown ◽  
R Foster ◽  
M Dodd ◽  
T McCormack
Keyword(s):  
Feasibility Study ◽  
Controlled Trial ◽  
Negative Attitude ◽  
Population Group ◽  
Ethics Committee ◽  
Willingness To Participate ◽  
Double Blind ◽  
North East ◽  
The North ◽  
Randomised Controlled

Abstract Introduction Emerging research suggests that statin use for primary prevention in people without diabetes aged 75 and older has no benefit. This study aims to determine the feasibility of the theoretical Stop Statin Study (3S), a double-blind randomised controlled trial carried out in general practice, which would test this hypothesis. 50% of trial patients would stop taking statins for 5 years in an event driven study. The questionnaires aim to identify the attitudes of general practitioners (GPs) and ethics committee members (ECMs) regarding stopping statins for 5 years in patients aged 75 and older without diabetes or history of cardiovascular disease and their willingness to allow patients to participate in the 3S study. Method Questionnaires comprised of 6 questions were designed. 4 students distributed the questionnaire and it was completed by 19 GPs based at 8 practices in the North-East of England. 31 ECMs (12 expert and 19 lay) responded by email. Results 95% of GPs who completed the survey would agree to their patients participating in the theoretical study with 47% of GPs indicating that their willingness to participate in the study is patient dependent. 95% of GPs would also consider stopping statins in this population group if sufficient research had been carried out or if the guidelines were changed. 42% of GPs have a negative attitude to prescribing statins in this population group. All the ECMs would approve the study, citing over-prescribing and polypharmacy as their reason. Conclusions The majority of GPs will participate in the theoretical 3S study, if their patients are willing to participate. There is already a negative perception amongst GPs towards the use of statins in elderly people without disease. The 3S study appears to be feasible from the GP and ethics perspective but would require a larger feasibility study.

scholarly journals Psychiatric hospital reform in low-income and middle-income countries Structured Individualised inTervention And Recovery (SITAR): a two-arm pragmatic randomised controlled trial study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e035753
Author(s):  
Tasneem Raja ◽  
Helena Tuomainen ◽  
Jason Madan ◽  
Dipesh Mistry ◽  
Sanjeev Jain ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Psychiatric Hospital ◽  
Patient Outcomes ◽  
Low Income ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Middle Income ◽  
Hospital Reform ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

IntroductionLow-income and middle-income settings like India have large treatment gaps in mental healthcare. People with severe mental disorders face impediments to their clinical and functional recovery, and have large unmet needs. The infrastructure and standards of care are poor in colonial period psychiatric hospitals, with no clear pathways to discharge and successfully integrate recovered individuals into the community. Our aim is to study the impact of psychiatric hospital reform on individual patient outcomes in a psychiatric hospital in India.Methods and analysisStructured Individualised inTervention And Recovery (SITAR) is a two-arm pragmatic randomised controlled trial, focusing on patients aged 18–60 years with a hospital stay of 12–120 months and a primary diagnosis of psychosis. It tests the effectiveness of structural and process reform with and without an individually tailored recovery plan on patient outcomes of disability (primary outcome WHO Disability Assessment Scale), symptom severity, social and occupational functioning and quality of life. A computer-generated permuted block randomisation schedule will allocate recruited subjects to the two study arms. We aim to recruit 100 people into each trial arm. Baseline and outcome measures will be undertaken by trained researchers independent to the case managers providing the individual intervention. A health economic analysis will determine the costing of implementing the individually tailored recovery plan.Ethics and disseminationThe study will provide answers to important questions around the nature and process of reforms in institutional care that promote recovery while being cognizant of protecting human rights, and dignity. Ethical approval for SITAR was obtained from a registered ethics committee in India (Institutional Ethics Committee VikasAnvesh Foundation, VAF/2018-19/012 dated 6 December 2018) and the University of Warwick’s Biomedical and Scientific Research Ethics Committee (REGO-2019–2332, dated 21 March 2019), and registered on the Central Trial Registry of India (CTRI/2019/01/017267). Trial results will be published in accordance to CONSORT guidelines.

scholarly journals Smartphone-supported Positive Adjustment Coping Intervention (PACI) for couples undergoing fertility treatment: a randomised controlled trial protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e025288 ◽  
Author(s):  
Maren Schick ◽  
Sabine Roesner ◽  
Ariane Germeyer ◽  
Markus Moessner ◽  
Stephanie Bauer ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Text Messages ◽  
Fertility Treatment ◽  
Psychosocial Burden ◽  
Waiting Period ◽  
Positive Adjustment ◽  
Psychosocial Counselling ◽  
Randomised Controlled

IntroductionInfertility generally counts as a profound crisis in the lives of couples and as an emotionally stressful experience. For couples undergoing fertility treatment, this is especially true of the waiting period following embryo transfer, which couples say is the most stressful period during treatment. However, at this specific phase, psychosocial counselling is not always available on the spot. The aim of this randomised controlled trial (RCT) study was to test the Positive Adjustment Coping Intervention (PACI), a low-dose, smartphone-supported psychological intervention for women and men undergoing fertility treatment.Methods and analysisThe effectiveness of PACI is tested by means of a prospective two-arm RCT. During the 14-day waiting period between oocyte puncture/oocyte thawing and pregnancy test, participants are randomly assigned to one of the two groups, and both women and men receive daily text messages on their smartphones. One group receives text messages with statements reflecting positive-adjustment coping attitudes, the other group messages containing cognitive distractions. The primary outcome of this study is the reduction of psychosocial burden during the waiting period of reproductive treatment. Furthermore, we want to assess whether there are differences between the interventions in a pre-post assessment. The secondary outcomes are information on perceived effectiveness and practicability of the intervention one month after the waiting period.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Heidelberg University Faculty of Medicine (S-074/2017). Study findings are planned for dissemination via peer-reviewed journal articles and at national and international conferences.Trial registration numberNCT03118219; Pre-results.Protocol versionVersion 2.0 dated 18/02/2019.

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