Abstract：
:Periconceptional supplementation could extend the period over which maternal and fetal nutrition is improved, but there are many challenges facing early-life intervention studies. Periconceptional trials differ from pregnancy supplementation trials, not only because of the very early or pre-gestational timing of nutrient exposure but also because they generate subsidiary information on participants who remain non-pregnant. The methodological challenges are more complex although, if well designed, they provide opportunities to evaluate concurrent hypotheses related to the health of non-pregnant women, especially nulliparous adolescents. This review examines the framework of published and ongoing randomised trial designs. Four cohorts typically arise from the periconceptional trial design--two of which are non-pregnant and two are pregnant--and this structure provides assessment options related to pre-pregnant, maternal, pregnancy and fetal outcomes. Conceptually the initial decision for single or micronutrient intervention is central--as is the choice of dosage and content--in order to establish a comparative framework across trials, improve standardisation, and facilitate interpretation of mechanistic hypotheses. Other trial features considered in the review include: measurement options for baseline and outcome assessments; adherence to long-term supplementation; sample size considerations in relation to duration of nutrient supplementation; cohort size for non-pregnant and pregnant cohorts as the latter is influenced by parity selection; integrating qualitative studies and data management issues. Emphasis is given to low resource settings where high infection rates and the possibility of nutrient-infection interactions may require appropriate safety monitoring. The focus is on pragmatic issues that may help investigators planning a periconceptional trial.
journal_name
Trialsjournal_title
Trialsauthors
Brabin BJ,Gies S,Owens S,Claeys Y,D'Alessandro U,Tinto H,Brabin Ldoi
10.1186/s13063-015-1124-0subject
Has Abstractpub_date
2016-01-30 00:00:00pages
58issn
1745-6215pii
10.1186/s13063-015-1124-0journal_volume
17pub_type
杂志文章相关文献
Trials文献大全abstract：BACKGROUND:A commonly reported problem with the conduct of multicentre randomised controlled trials (RCTs) is that recruitment is often slower or more difficult than expected, with many trials failing to reach their planned sample size within the timescale and funding originally envisaged. The aim of this study was to ...
journal_title：Trials
pub_type： 杂志文章
doi：10.1186/1745-6215-7-9
更新日期：2006-04-07 00:00:00
abstract：BACKGROUND:Patients' treatment preferences are often cited as barriers to recruitment in randomized controlled trials (RCTs). We investigated how RCT recruiters reacted to patients' treatment preferences and identified key strategies to improve informed decision-making and trial recruitment. METHODS:Audio-recordings o...
journal_title：Trials
pub_type： 杂志文章
doi：10.1186/1745-6215-15-323
更新日期：2014-08-13 00:00:00
abstract：BACKGROUND:Classroom-based stuttering intervention addressing negative peer attitudes, perceptions, teasing and bullying of children who stutter (CWS) is required as part of holistic stuttering management because of its occurrence in primary school. This study was conducted in 2017, in 10 primary schools in the Western...
journal_title：Trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1186/s13063-018-3043-3
更新日期：2018-11-29 00:00:00
abstract：OBJECTIVES:Assessing the effect of surfactant on clinical outcome in patients with COVID-19 under mechanical ventilation TRIAL DESIGN: Single centre, two arm, parallel group (1:1 allocation ratio), randomised superiority trial with blinded care and outcome assessment. PARTICIPANTS:Inclusion criteria: Adult COVID-19 pa...
journal_title：Trials
pub_type： 信件
doi：10.1186/s13063-020-04815-z
更新日期：2020-11-11 00:00:00
abstract：BACKGROUND:The prevalence of depressive disorder in adults with advanced cancer is around 20 %. Although cognitive behavioural therapy (CBT) is recommended for depression and may be beneficial in depressed people with cancer, its use for depression in those with advanced disease for whom cure is not likely has not been...
journal_title：Trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1186/s13063-016-1223-6
更新日期：2016-02-29 00:00:00
abstract：BACKGROUND:Spinal manipulative therapy is commonly used in the treatment of adolescent idiopathic scoliosis. Some therapists also rely on physiotherapeutic scoliosis-specific exercise (PSSE). Combining these two modalities seems reasonable, but the effectiveness of this combination has never been rigorously tested. Her...
journal_title：Trials
pub_type： 杂志文章
doi：10.1186/s13063-020-05000-y
更新日期：2021-01-14 00:00:00
abstract：BACKGROUND:Multiple sclerosis (MS) is an inflammatory disease of the central nervous system with a degenerative component, leading to irreversible disability. Mesenchymal stem cells (MSC) have been shown to prevent inflammation and neurodegeneration in animal models of MS, but no large phase II clinical trials have yet...
journal_title：Trials
pub_type： 杂志文章
doi：10.1186/s13063-019-3346-z
更新日期：2019-05-09 00:00:00
abstract：BACKGROUND:Idiopathic sudden sensorineural hearing loss (ISSNHL) is a major cause of deafness. Despite the advances in systemic therapy, some cases of ISSNHL are untreated, because the exact ISSNHL aetiology is unclear. Traditional Chinese medicine (TCM) has been used to treat diseases for thousands of years and is pop...
journal_title：Trials
pub_type： 杂志文章
doi：10.1186/s13063-019-3733-5
更新日期：2019-12-02 00:00:00
abstract：BACKGROUND:The objective of this research was to evaluate data from a randomized clinical trial that tested injectable diacetylmorphine (DAM) and oral methadone (MMT) for substitution treatment, using a multi-domain dichotomous index, with a Bayesian approach. METHODS:Sixty two long-term, socially-excluded heroin inje...
journal_title：Trials
pub_type： 杂志文章,随机对照试验
doi：10.1186/1745-6215-10-70
更新日期：2009-08-14 00:00:00
abstract：BACKGROUND:Colonoscopy is one of the most effective methods of cancer prevention and detection, particularly for individuals with familial risk. Recruitment of family members to behavioral intervention trials remains uniquely challenging, owing to the intensive process required to identify and contact them. Recruiting ...
journal_title：Trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1186/1745-6215-14-116
更新日期：2013-04-30 00:00:00
abstract：BACKGROUND:Diabetes mellitus is associated with risk of sudden sensorineural hearing loss (SSNHL). Systemic and intratympanic corticosteroids are the two primary treatments for SSNHL in patients with diabetes mellitus. The benefit of intratympanic compared to systemic treatment is the reduced systemic steroid exposure ...
journal_title：Trials
pub_type： 杂志文章
doi：10.1186/s13063-020-4077-x
更新日期：2020-02-03 00:00:00
abstract：BACKGROUND:Generalised anxiety disorder (GAD) is a chronic and disabling condition with considerable personal and economic impact. Cognitive behavioural therapy (CBT) is a recommended psychological therapy for GAD; however, there are substantial barriers to accessing treatment. Digital CBT, in particular smartphone-del...
journal_title：Trials
pub_type： 杂志文章
doi：10.1186/s13063-020-4230-6
更新日期：2020-04-23 00:00:00
abstract：BACKGROUND:Neck pain is a common symptom in most patients suffering from cervical radiculopathy. However, some conservative treatments are limited by their modest effectiveness. On the other hand, surgical intervention for cervical disc disorders is indicated when symptoms are refractory to conservative treatments and ...
journal_title：Trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1186/1745-6215-14-322
更新日期：2013-10-07 00:00:00
abstract：BACKGROUND:Equine-assisted therapy is more often practiced with children and adolescents than with the elderly, although individuals in the second half of life could also profit from it. This group, from the age of 50, is characterised by increasing emotional, social, health-related and cognitive changes; a critical li...
journal_title：Trials
pub_type： 杂志文章
doi：10.1186/s13063-020-04784-3
更新日期：2020-10-15 00:00:00
abstract：BACKGROUND:Trials in rare diseases have many challenges, among which are the need to set up multiple sites in different countries to achieve recruitment targets and the divergent landscape of clinical trial regulations in those countries. Over the past years, there have been initiatives to facilitate the process of int...
journal_title：Trials
pub_type： 杂志文章,评审
doi：10.1186/s13063-018-2645-0
更新日期：2018-05-10 00:00:00
abstract：BACKGROUND:Most people who stop smoking successfully for a few weeks will return to smoking again in the medium term. There are few effective interventions to prevent this relapse and none used routinely in clinical practice. A previous exploratory meta-analysis suggested that self-help booklets may be effective but re...
journal_title：Trials
pub_type： 杂志文章,随机对照试验
doi：10.1186/1745-6215-13-69
更新日期：2012-05-30 00:00:00
abstract：BACKGROUND:Sleep disturbance in older people is an important health issue that is associated with many other health problems. Effective interventions are required to address sleep problems in this group. Acupressure has been suggested as a potential therapeutic technique to improve sleep. The aim of this study is to ev...
journal_title：Trials
pub_type： 杂志文章
doi：10.1186/s13063-020-04286-2
更新日期：2020-04-25 00:00:00
abstract：BACKGROUND:Hand-assisted laparoscopic living donor nephrectomy (HALDN) using a periumbilical or Pfannenstiel incision was developed to improve donor outcome after a kidney transplant. The aim of this study was to investigate two methods of hand assistance and kidney removal during HALDN and their effect on the time it ...
journal_title：Trials
pub_type： 杂志文章
doi：10.1186/s13063-018-2775-4
更新日期：2018-07-13 00:00:00
abstract：BACKGROUND:Worldwide, prevalence rates of adolescent non-suicidal self-injury (NSSI) range between 13 and 45%. In Germany, lifetime prevalence of NSSI is around 25% in non-clinical samples, and the one-year prevalence for repetitive NSSI is 4%. NSSI is present in the context of several axis I and II disorders (for exam...
journal_title：Trials
pub_type： 杂志文章,随机对照试验
doi：10.1186/1745-6215-14-294
更新日期：2013-09-13 00:00:00
abstract：BACKGROUND:Depression is a common affliction for young adults, and is associated with a range of adverse outcomes. Cognitive-reminiscence therapy is a brief, structured intervention that has been shown to be highly effective for reducing depressive symptoms, yet to date has not been evaluated in young adult populations...
journal_title：Trials
pub_type： 杂志文章,随机对照试验
doi：10.1186/1745-6215-14-343
更新日期：2013-10-21 00:00:00
abstract：BACKGROUND:Intra-operative electrocorticography, based on interictal spikes and spike patterns, is performed to optimize delineation of the epileptogenic tissue during epilepsy surgery. High frequency oscillations (HFOs, 80-500 Hz) have been identified as more precise biomarkers for epileptogenic tissue. The aim of the...
journal_title：Trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1186/s13063-015-0932-6
更新日期：2015-09-23 00:00:00
abstract：BACKGROUND:Post-dural puncture headache (PDPH) is one of the most common complications of neuraxial anaesthesia. It limits patients' general activity and increases the length of hospital stays and the use of care. It is particularly disabling during the postpartum period, when mothers have to take care of their child. ...
journal_title：Trials
pub_type： 杂志文章
doi：10.1186/s13063-019-4015-y
更新日期：2020-01-08 00:00:00
abstract：BACKGROUND:Idiopathic sudden sensorineural hearing loss (ISSNHL) is a rapid-onset sensorineural hearing impairment with unclear etiology and unsatisfying treatment effects. Vestibular dysfunction has been considered as a poor indicator in the clinical manifestations and prognosis of ISSNHL, which occurred in approximat...
journal_title：Trials
pub_type： 杂志文章
doi：10.1186/s13063-020-04579-6
更新日期：2020-07-22 00:00:00
abstract：BACKGROUND:Malaria transmission is highly heterogeneous in most settings, resulting in the formation of recognizable malaria hotspots. Targeting these hotspots might represent a highly efficacious way of controlling or eliminating malaria if the hotspots fuel malaria transmission to the wider community. METHODS/DESIGN...
journal_title：Trials
pub_type： 杂志文章,随机对照试验
doi：10.1186/1745-6215-14-36
更新日期：2013-02-02 00:00:00
abstract：BACKGROUND:Adaptive servo-ventilation (ASV) therapy, which is a form of noninvasive positive pressure ventilation therapy and uses an innovative ventilator that has simple operability and provides good patient adherence, potentially has therapeutic benefits-suppression of the deterioration and progression of chronic he...
journal_title：Trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1186/s13063-014-0530-z
更新日期：2015-01-16 00:00:00
abstract：OBJECTIVES:To evaluate the safety of therapeutic plasma exchange (TPE) in adult patients with serious/life-threatening COVID-19 requiring intensive care unit (ICU) admission, and associated 28-day mortality. Serious and life threatening COVID-19 are defined as per published literature (please, refer to the full protoco...
journal_title：Trials
pub_type： 信件
doi：10.1186/s13063-020-04454-4
更新日期：2020-06-08 00:00:00
abstract：BACKGROUND:Eyes sustaining open globe trauma are at high risk of severe visual impairment. Ocular injuries which result in visual loss invariably affect the posterior segment of the eye, and prevention of visual loss involves posterior segment (vitreoretinal) surgery. Despite improvements in vitreoretinal surgical tech...
journal_title：Trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1186/s13063-016-1445-7
更新日期：2016-07-22 00:00:00
abstract：BACKGROUND:As the toxicity associated with the α-GalCer-pulsed dendritic cell (DC) therapy could be considered to be negligible, its addition to postoperative adjuvant chemotherapy would be expected to greatly improve the therapeutic effect, and could result in prolonged survival. The aim of the present study is to com...
journal_title：Trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1186/s13063-017-2103-4
更新日期：2017-09-15 00:00:00
abstract：BACKGROUND:Acute myocardial infarction (AMI) is the leading cause of mortality worldwide. Oxidative stress has been involved in the ischemia-reperfusion injury in AMI. It has been suggested that reperfusion accounts for up to 50% of the final size of a myocardial infarct, a part of the damage likely to be prevented.The...
journal_title：Trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1186/1745-6215-15-192
更新日期：2014-05-29 00:00:00
abstract：BACKGROUND:Same-sex attracted young adults have been found to experience higher rates of mental health problems and greater difficulties in accessing specialist mental health care services compared to their heterosexual peers. Internet-based mental health interventions have the potential to be more engaging and accessi...
journal_title：Trials
pub_type： 杂志文章,随机对照试验
doi：10.1186/1745-6215-15-504
更新日期：2014-12-23 00:00:00
