scholarly journals Writing up your clinical trial report for a scientific journal: The REPORT trial guide for effective and transparent research reporting without spin

2021 ◽  
Author(s):  
Thomas Bandholm ◽  
Kristian Thorborg ◽  
Clare Louise Ardern ◽  
Robin Christensen ◽  
Marius Henriksen
Keyword(s):  
Clinical Trial ◽  
Open Access ◽  
Controlled Trial ◽  
Scientific Journal ◽  
Trial Report ◽  
Research Reporting ◽  
First Choice ◽  
Randomised Controlled ◽  
Study Designs ◽  
Structure Choice

The REPORT guide is a “How to” guide to help you achieve effective and transparent clinical trial reporting. It is intended to supplement “first choice” reporting tools, such as CONSORT, by adding tacit knowledge about reporting topics we have struggled with as authors or see others struggle with as journal reviewers or editors. Focus is the randomised controlled trial, but the guide is useful for other study designs as well. Topics included in the REPORT guide cover reporting checklists, trial report structure, choice of title, writing style, trial registry and reporting consistency, spin or reporting bias, transparent data presentation (figures), open access considerations, data sharing, and much more. We hope you find it useful.Preprint (open access): https://doi.org/xxxxxxxxxxxxxxx

scholarly journals Tackling frailty at primary care: evaluation of the effectiveness of a multicomponent intervention through a randomised controlled trial: study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034591
Author(s):  
Francisco Rivas-Ruiz ◽  
Mónica Machón ◽  
Maider Mateo-Abad ◽  
Eugenio Contreras-Fernández ◽  
Carolina Güell ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Functional Capacity ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Scientific Journal ◽  
Controlled Clinical Trial ◽  
Multifactorial Intervention ◽  
Randomised Controlled

IntroductionThis project focuses on how frailty is addressed in primary healthcare (PHC) and will evaluate the effectiveness of a multifactorial intervention (considering the appropriateness of the pharmaceutical prescription, the nutritional care provided and the exercise intervention) for persons with frailty, in terms of improving their functional capacity and reducing the incidence of adverse events related to frailty. The final evaluation will be made at 12 months’ follow-up.Methods and analysisPragmatic multicentre cluster randomised controlled clinical trial, single blind with two arms: multifactorial intervention in PHC versus usual follow-up. The randomisation unit is the patient list and the analysis unit is the patient. In addition, a cost-effectiveness study and a qualitative study will be carried out, the latter based on semistructured interviews and focus groups. Two hundred persons (100 per study branch) all aged ≥70 years, presenting frailty, but functionally independent and resident in the community, will be recruited. A baseline evaluation will be carried out prior to the intervention, with follow-up at 6 and 12 months. The main study variables considered will be functional capacity and incidence of adverse events; the secondary variables considered will be the patients’ sociodemographic characteristics, nutritional status, level of physical activity and drug consumption, together with data on comorbidity, cognitive and affective status and health-related quality of life. Data will be analysed according to the intention-to-treat principle using a 5% significance level.Ethics and disseminationThe study will at all times be conducted in strict accordance with the provisions of the Declaration of Helsinki and with the national legislation regulating patients’ autonomy. All patients recruited will be asked to provide written informed consent before taking part in the clinical trial. On completion of the study, the principal investigator expects to publish the results of this research in a peer-reviewed open access scientific journal.Trial registration numberISRCTN17143761.

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.

Process and Resource Assessment in Trials Undertaken in Residential Care Homes: Experiences from the Australian MIDDEL Cluster Randomised Controlled Trial Research Team.

2020 ◽  
Author(s):  
Felicity Anne Baker ◽  
Phoebe Stretton-Smith ◽  
Tanara Vieira Sousa ◽  
Imogen Clark ◽  
Alice Cotton ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Resource Assessment ◽  
Trial Registration ◽  
Residential Aged Care ◽  
Cluster Randomised ◽  
Intervention Adherence ◽  
Randomised Controlled

Abstract Background: The resources involved in delivering a clinical trial in residential aged care facilities (RACFs) are significant and the success of a trial is dependent upon adequate planning, including appropriate timelines for each component of the study and the required budget. The main aim of this paper is to describe process and resource assessment during recruitment, collection of outcome measures and intervention delivery and present learnings and considerations for conducting trials in RACFs with people living with dementia. Methods: We collected data across 24 clusters in 12 RACFs over 18 months during a cluster randomised controlled trial which was testing the effectiveness of music interventions in people living with dementia. Data were collected on resources required for recruitment and assessment of baseline data, as well as data on reasons for participant non-attendance at the interventions. Results: Results show that time between contacting next of kin and receiving formal consent often exceeded 45 days and the ratio of time between direct and indirect research activity is approximately 1:2. Participant intervention adherence is at risk from unplanned RACF lockdowns and reasons for non-attendance include those both related directly to the participant and to staff resources, scheduling or other practical considerations. Conclusions: Researchers planning studies within RACFs should focus on building relationships with RACF staff and resident families, factor in adequate time for recruitment in the study timeline and consider budgeting for backfill of RACF staff during data collection phases to expedite the process and ensure adherence to study protocol timelines. This study provides specific data on resource assessment and intervention adherence that could be beneficial for future researchers planning to conduct trials in RACFs with people with dementia. Trial registration: Australian and New Zealand Clinical Trial Registry: ANZCTR12618000156280, 1/02/2018, http://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618000156280

scholarly journals Naoxuekang, Xinnaoshutong and Xuesaitong capsules for treating stroke: a protocol for a randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e015983 ◽  
Author(s):  
Huiling Chen ◽  
Hongbo Cao ◽  
Xu Guo ◽  
Meidan Zhao ◽  
Qing Xia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Facial Paralysis ◽  
Controlled Trial ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Initial Treatment Period ◽  
Double Blind Clinical Trial ◽  
Registration Number ◽  
Index Value ◽  
Randomised Controlled

IntroductionAfter stroke, hemiplegia, dysphasia and facial paralysis can manifest during the convalescent period. Currently, no Chinese patent medicine (CPM) is previously reported to cure each of these symptoms primarily, and thus, there are no relevant instructions for the use of CPM. This study presents a new approach based on comparative effectiveness research to distinguish the curative effects of three CPMs that are often used in stroke convalescence to determine the ideal medicine for the treatment of each symptom.Methods and analysisIn this multicentre and double-blind clinical trial, stratified randomisation is used to group the patients according to their primary symptoms (hemiplegia, dysphasia and facial paralysis). Three strata will be enrolled, with 80 eligible participants included in each stratum. Each stratum will be randomly and equally divided into four groups, and each group will receive one of the following treatments: Naoxuekang, Xinnaoshutong (XNST), Xuesaitong (XST) or placebo. This study will include two stages: the initial treatment period (30 days) and a follow-up period (180 days). Three replicates for each data point will be completed during this trial. The first visit will occur on day 0 after enrolment, the second visit on day 30±2 and the third visit on day 210±5. The Delphi technique is adopted to achieve index weighting, which ensures that the evaluation outcome is patient oriented. The weighted index value will be computed as the final measurement index of the outcome.Ethics and disseminationThis study has been approved by the Medical Ethics Committee of Tianjin University of Traditional Chinese Medicine (registration number TJUTCM-EC20160007). The results will be offered for publication in peer-reviewed journals.Trial registration numberThis trial was registered with the Chinese Clinical Trial Registry (ChiCTR-IOR-17010397). The date of registration was 11 January 2017.

scholarly journals Effectiveness and safety of early intramuscular botulinum toxin injections to prevent shoulder deformity in babies with brachial plexus birth injury (POPB-TOX), a randomised controlled trial: study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e032901 ◽  
Author(s):  
Christelle Pons ◽  
Dauphou Eddi ◽  
Gregoire Le Gal ◽  
Marc Garetier ◽  
Douraied Ben Salem ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Botulinum Toxin ◽  
Randomised Controlled Trial ◽  
Humeral Head ◽  
Controlled Trial ◽  
Birth Injury ◽  
Posterior Subluxation ◽  
Randomised Controlled ◽  
Botulinum Toxin Injections ◽  
Brachial Plexus Birth Injury

IntroductionIn children with brachial plexus birth injury (BPBI), denervation of the shoulder muscles leads to bony deformity in the first months of life, reducing active and passive range of motion (ROM) and causing activity limitation. The aim of this multicentre randomised controlled trial is to evaluate the effectiveness of botulinum toxin injections (BTI) in the shoulder internal rotator muscles of 12-month-old babies in limiting the progression of posterior subluxation of the glenohumeral joint, compared with a sham procedure mimicking BTI. The secondary aims are to evaluate the effectiveness of BTI in (1) limiting the progression of glenoid retroversion and three-dimensional (3D) deformity and (2) improving shoulder ROM and upper limb function, as well as to confirm the tolerance of BTI.Methods and analysisSixty-two babies with unilateral BPBI and a risk of posterior humeral head subluxation will be included. Only those with at least 7% posterior subluxation of the humeral head compared with the contralateral shoulder on the MRI will be randomised to one of two groups: ‘BTI’ and ‘Sham’. The BTI group will receive BOTOX injections at the age of 12 months in the internal shoulder rotator muscles (8 UI/kg). The sham group will undergo a sham BTI procedure. Both groups will undergo repeated shoulder MRI at 18 months of age to quantify changes in the percentage of posterior migration of the humeral head (primary outcome), glenoid version and 3D bone deformity. Clinical evaluations (passive shoulder ROM, active movement scale) will be carried out at baseline and 15 and 18 months of age. The mini-assisting hand assessment will be rated between 10 and 11 months and at 18 months of age. Adverse events will be recorded at least monthly for each child.Ethics and disseminationFull ethical approval for this study has been obtained. The findings will be disseminated in peer-reviewed publications.Trial registration numberEudraCT: 2015-001402-34 in European Clinical Trial database;NCT03198702in Clinical Trial database; Pre-results.

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