Abstract:
BACKGROUND:Adverse events (AEs) in clinical trials may be reported in multiple sources. Different methods for reporting adverse events across trials or across sources for a single trial may produce inconsistent information about the adverse events associated with interventions. METHODS:We compared the methods authors use to decide which AEs to include in a particular source (i.e., "selection criteria"), including the number of different types of AEs reported (i.e., rather than the number of events). We compared sources (e.g., journal articles, clinical study reports (CSRs)) of trials for two drug-indications-gabapentin for neuropathic pain and quetiapine for bipolar depression. Electronic searches were completed in 2015. We identified selection criteria and assessed how criteria affected AE reporting. RESULTS:We identified 21 gabapentin and 7 quetiapine trials. We found 6 gabapentin CSRs and 2 quetiapine CSRs, all written by drug manufacturers. All CSRs reported all AEs without applying selection criteria; by comparison, no other source reported all AEs, and 15/68 (22%) gabapentin sources and 19/48 (40%) quetiapine sources reported using selection criteria. Selection criteria greatly affected the number of AEs reported. For example, 67/316 (21%) AEs in one quetiapine trial met the criterion "occurring in ≥2% of participants in any treatment group," while only 5/316 (2%) AEs met the criterion "occurring in ≥10% of quetiapine-treated patients and twice as frequent in the quetiapine group as the placebo group." CONCLUSIONS:Selection criteria for reporting AEs vary across trials and across sources for individual trials. If investigators do not pre-specify selection criteria, they might "cherry-pick" AEs based on results. Even if investigators pre-specify selection criteria, selective reporting will produce biased meta-analyses and clinical practice guidelines. Data about all AEs identified in clinical trials should be publicly available; however, sharing data will not solve all the problems identified in this study.
journal_name
Trialsjournal_title
Trialsauthors
Mayo-Wilson E,Fusco N,Hong H,Li T,Canner JK,Dickersin Kdoi
10.1186/s13063-019-3581-3subject
Has Abstractpub_date
2019-09-05 00:00:00pages
553issue
1issn
1745-6215pii
10.1186/s13063-019-3581-3journal_volume
20pub_type
杂志文章相关文献
Trials文献大全abstract:BACKGROUND:Current international guidelines recommend the use of a daily topical exit-site antimicrobial to prevent peritoneal dialysis (PD)-related infections. Although nonantibiotic-based therapies are appealing because they may limit antimicrobial resistance, no controlled trials have been conducted to compare topic...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3953-8
更新日期:2019-12-19 00:00:00
abstract:BACKGROUND:South Africa is among the seven highest tuberculosis (TB) burden countries. Harmful lifestyle behaviours, such as smoking and alcohol, and poor adherence to medication can affect clinical outcomes. Modification of these behaviours is likely to improve TB treatment outcomes and has proven possible using motiv...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3551-9
更新日期:2019-07-26 00:00:00
abstract:BACKGROUND:Postoperative knee swelling is common and impairs early postoperative function following total knee arthroplasty. It was hypothesised that the use of a short-stretch, inelastic compression bandage would reduce knee swelling and improve pain and early function. The aim of this study was to provide preliminary...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-016-1767-5
更新日期:2017-01-09 00:00:00
abstract:BACKGROUND:Generalised anxiety disorder (GAD) is a chronic and debilitating condition characterised by high co-morbidity. Alongside pharmacological treatment, cognitive behavioural therapy (CBT) is an established psychological therapy for GAD. Its effectiveness is limited, however, with only an estimated 50% of clients...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2892-0
更新日期:2018-09-19 00:00:00
abstract:BACKGROUND:Among clinical trials of interventions that aim to modify time spent on mechanical ventilation for critically ill patients there is considerable inconsistency in chosen outcomes and how they are measured. The Core Outcomes in Ventilation Trials (COVenT) study aims to develop a set of core outcomes for use in...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0905-9
更新日期:2015-08-20 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:Maintaining adequate oxygenation during rapid sequence intubation (RSI) is imperative to prevent peri-intubation adverse events that can lead to increased duration of hospital and intensive care unit stay, or a prolonged vegetative state requiring long-term institutionalisation. Despite employing current bes...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3305-8
更新日期:2019-04-04 00:00:00
abstract:BACKGROUND:Individuals who sustain traumatic brain injuries (TBIs) often continue to experience significant impairment of cognitive functions mediated by the prefrontal cortex well into chronic stages of recovery. Traditional brain training programs that focus on improving specific skills fall short of addressing integ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-14-29
更新日期:2013-01-30 00:00:00
abstract:BACKGROUND:Attention-deficit hyperactivity disorder (ADHD) is a mental disorder beginning in childhood, and about half of patients have symptoms lasting into adulthood. Adult ADHD causes various impairments of emotional, self-esteem, and executive function and life quality aspects. Furthermore, adverse outcomes include...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0686-1
更新日期:2015-04-14 00:00:00
abstract:BACKGROUND:Although conventional laparoscopic and hand-assisted laparoscopic surgery for colorectal cancer is widely used today, there remain many technical challenges especially for right colon cancer in obese patients. Herein, we develop a novel hand-assisted laparoscopic surgery (HALS) with complete mesocolic excisi...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-017-2084-3
更新日期:2017-07-26 00:00:00
abstract:BACKGROUND:Individuals with chronic lung disease are more susceptible to present reduction in exercise tolerance and muscles strength not only due to pulmonary limitations but also due systemic repercussions of the pulmonary disease. The aim of this study is to assess the physical capacity, peripheral muscle function, ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0876-x
更新日期:2015-08-13 00:00:00
abstract:BACKGROUND:Exercise-based cardiac rehabilitation is a beneficial therapy for patients with chronic heart failure. The delivery of exercise-based cardiac rehabilitation should adopt an evidence-based approach, as well as be culturally appropriate and sensitive to individual needs and preferences. The Baduanjin Eight-Sil...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2531-9
更新日期:2018-03-01 00:00:00
abstract:BACKGROUND:Cardiovascular diseases are the major cause of death in the world. Current treatments have not been able to reverse this scenario, creating the need for the development of new therapies. Cell therapies have emerged as an alternative for cardiac diseases of distinct causes in experimental animal studies and m...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-8-2
更新日期:2007-01-18 00:00:00
abstract:BACKGROUND:Chronic musculoskeletal pain (MSP) affects more than 40% of adults aged 50 years and older and is the leading cause of disability in the USA. Older adults with chronic MSP are at risk for analgesic-related side effects, long-term opioid use, and functional decline. Recognizing the burden of chronic MSP, redu...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04552-3
更新日期:2020-07-06 00:00:00
abstract:BACKGROUND:Noncompliance to treatment assignment is an inevitable occurrence in randomized clinical trials (RCTs). Intention to treat (ITT) is generally considered the best method for addressing noncompliance in RCTs. Alternatives to ITT exist, including per protocol (PP), as treated (AT), and instrumental variables (I...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-015-1044-z
更新日期:2015-11-17 00:00:00
abstract:BACKGROUND:High-protein diets and total diet replacements are becoming increasingly popular for weight regulation; however, further research is needed to elucidate their impact on the physiology of body weight regulation. The aim of this inpatient metabolic balance study is to compare the impact of a high-protein total...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3950-y
更新日期:2019-12-27 00:00:00
abstract:BACKGROUND:Irritable bowel syndrome (IBS) is reported by one in ten of the population accounting for up to 40% of new referrals to gastroenterology outpatients. Patients characteristically have abdominal discomfort and disturbed bowel habit. Diarrhoea-predominant IBS is characterised by frequent loose stools with assoc...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-14-10
更新日期:2013-01-09 00:00:00
abstract:BACKGROUND:Despite recent advances in the medical and surgical fields, complications such as infection, pneumonia, or brain swelling may occur after a craniotomy. In some patients, perioperative antibiotic prophylaxis causes adverse effects such as itching, rash, or digestive conditions. Certain patients still develop ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-016-1712-7
更新日期:2017-01-10 00:00:00
abstract:BACKGROUND:Despite the promise and popularity of advance care planning, there is insufficient evidence that advance care planning helps patients to meet their end-of-life care preferences, especially in Asian settings. Thus, the proposed study aims to assess whether patients with advanced heart failure who are receivin...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-016-1414-1
更新日期:2016-06-10 00:00:00
abstract:BACKGROUND:A wound that does not heal in the orderly stages of the healing process or does not heal within 3 months is considered a chronic wound. Wound healing is impaired when the wound remains in the inflammatory stage for too long. A range of factors can delay the healing process: imbalance between proteases and pr...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04445-5
更新日期:2020-06-08 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:Psychosis is a serious mental illness that typically emerges during early adulthood. The disorder is characterized by inactivity, cognitive deficits and the need for ongoing support. Regular exercise has mood enhancing and anxiolytic effects that could benefit this patient group. To date, few studies have ex...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-1071-9
更新日期:2015-12-04 00:00:00
abstract:BACKGROUND:Many patients at high risk of cardiovascular disease do not achieve recommended low-density lipoprotein cholesterol (LDL-C) goals. This study compared the efficacy and safety of low doses of rosuvastatin (10 mg) and atorvastatin (20 mg) in high-risk patients with hypercholesterolemia. METHODS:A total of 996...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-7-35
更新日期:2006-12-21 00:00:00
abstract:BACKGROUND:In bipolar spectrum disorder, some individuals experience ongoing, frequent fluctuations in mood outside of affective episodes. There are currently no evidence-based psychological interventions designed to address this. This feasibility study is a phase II evaluation of a dialectical behavioural therapy-info...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2926-7
更新日期:2018-10-16 00:00:00
abstract:BACKGROUND:Asthma is a prevalent and costly disease resulting in reduced quality of life for a large proportion of individuals. Effective patient self-management is critical for improving health outcomes. However, key aspects of self-management such as self-monitoring of behaviours and symptoms, coupled with regular fe...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-12-260
更新日期:2011-12-14 00:00:00
abstract:BACKGROUND:Enrollment in interventional therapeutic clinical trials is a small fraction of all patients who might participate given reasonable access. METHODS:A hierarchical approach is utilized in measuring staged participation from trial availability to patient enrollment. Our framework suggests that concern for jus...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-13-237
更新日期:2012-12-10 00:00:00
abstract:BACKGROUND:Mindfulness-based interventions, modified and shortened versions of meditation teachings, have proved to be effective in the improvement of quality of life in many clinical conditions, including chronic diseases. Preliminary results available in the literature and in clinical experience indicate a high poten...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-1136-9
更新日期:2016-01-04 00:00:00
abstract:BACKGROUND:The introduction of anti-tumor necrosis factor medications has revolutionized the treatment of psoriasis with achievement of treatment goals (Psoriasis Area and Severity Index score 75, remission) that are not usually met with conventional systemics. Nevertheless, some patients continue to experience persist...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-017-1777-y
更新日期:2017-02-02 00:00:00
abstract:BACKGROUND:The focus in recent years on physical inactivity and metabolic disturbances in individuals with schizophrenia raises the question of potential effects of physical activity. Physical activity has shown beneficial effects on cognition in healthy older individuals as well as on symptom severity in depression. H...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-015-1094-2
更新日期:2015-12-08 00:00:00
abstract:BACKGROUND:Individual patient data (IPD) meta-analysis is considered the "gold standard" for exploring the effectiveness of interventions in different subgroups of patients. However, obtaining IPD is time-consuming and contact with the researchers responsible for the original trials is usually required. To date, there ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-016-1238-z
更新日期:2016-03-15 00:00:00