Selective reporting in clinical trials: analysis of trial protocols accepted by The Lancet

Al-Marzouki, Sanaa; Roberts, Ian; Evans, Stephen; Marshall, Tom

doi:10.1016/s0140-6736(08)61060-0

Cited by 106 publications

(73 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…thelancet.com/journals/lancet/misc/protocol). Only 75 protocols had been accepted and registered in The Lancet by June 2007, 373 and up to the time of writing (August 2008) fewer than 100 protocols had been registered in this way; other journals are yet to follow suit. Registration of study protocols by paper journals, although a good idea, is clearly not going to help to prevent publication bias in the bulk of research, and it is still feasible for a study to be registered with The Lancet, but not published by them if the results are not deemed appropriate for whatever reason.…”

Section: Prospective Registration Of Trialsmentioning

confidence: 99%

Dissemination and publication of research findings: an updated review of related biases

Song

Parekh²,

Hooper³

et al. 2010

Health Technol Assess

818

682

View full text Add to dashboard Cite

How to obtain copies of this and other HTA programme reports An electronic version of this title, in Adobe Acrobat format, is available for downloading free of charge for personal use from the HTA website (www.hta.ac.uk). A fully searchable DVD is also available (see below).Printed copies of HTA journal series issues cost £20 each (post and packing free in the UK) to both public and private sector purchasers from our despatch agents.Non-UK purchasers will have to pay a small fee for post and packing. For European countries the cost is £2 per issue and for the rest of the world £3 per issue. How to order:-fax (with credit card details) -post (with credit card details or cheque) -phone during office hours (credit card only).Additionally the HTA website allows you to either print out your order or download a blank order form. Contact details are as follows:Synergie UK (HTA Department) Digital House, The Loddon Centre Wade Road Basingstoke Hants RG24 8QW Email: orders@hta.ac.uk Tel: 0845 812 4000 -ask for 'HTA Payment Services' (out-of-hours answer-phone service) Fax: 0845 812 4001 -put 'HTA Order' on the fax header Payment methods Paying by chequeIf you pay by cheque, the cheque must be in pounds sterling, made payable to University of Southampton and drawn on a bank with a UK address. Paying by credit cardYou can order using your credit card by phone, fax or post. SubscriptionsNHS libraries can subscribe free of charge. Public libraries can subscribe at a reduced cost of £100 for each volume (normally comprising 40-50 titles). The commercial subscription rate is £400 per volume (addresses within the UK) and £600 per volume (addresses outside the UK). Please see our website for details. Subscriptions can be purchased only for the current or forthcoming volume. How do I get a copy of HTA on DVD?Please use the form on the HTA website (www.hta.ac.uk/htacd/index.shtml). HTA on DVD is currently free of charge worldwide.The website also provides information about the HTA programme and lists the membership of the various committees. HTA NIHR Health Technology Assessment programmeT he Health Technology Assessment (HTA) programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care. The research findings from the HTA programme directly influence decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC). HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they form a key component of the 'National Knowledge Service'. The HTA programme is needs led in that it fills gaps in the evidence needed by the NHS. There are three routes to the start of project...

show abstract

Section: Prospective Registration Of Trialsmentioning

confidence: 99%

Dissemination and publication of research findings: an updated review of related biases

Song

Parekh²,

Hooper³

et al. 2010

Health Technol Assess

818

682

View full text Add to dashboard Cite

show abstract

“…Other studies have revealed discrepancies in statistical methods reported in protocols and subsequent publications (eg, planned versus reported subgroup analyses). 36,37 A study examining the impact of selective outcome reporting on the results of metaanalysis revealed that approximately half of the trials identified as relevant to a systematic review did not contribute to the meta-analysis of patientimportant outcomes. 38 Further, the effect estimates decreased as the proportion of relevant studies contributing to the meta-analysis increased.…”

Section: Selective Outcome Reportingmentioning

confidence: 99%

Standard 2: Containing Risk of Bias

et al. 2012

View full text Add to dashboard Cite

DILEMMAThere is a crisis of credibility facing the child health research community because of the paucity of reliable estimates of the effects of interventions in children. Associations between risk of bias assessments and treatment effect estimates have important implications, for the clinician, and the families face important challenges as decisionmakers stemming from results that exaggerate treatment effectiveness or safety. Consequently, interventions that are not efficacious and potentially harmful may be prescribed, whereas interventions that truly are efficacious may be withheld. [1][2][3][4][5] Positive trends in pediatric research have been observed since the first trial was published in 1948. Specifically, there has been a substantial increase in the number of trials published over time, the proportion of randomized to nonrandomized controlled trials, and the proportion of child to adult trials. 6 Reporting of methods has also improved; however, methodological quality remains modest. 6 Three studies have specifically examined risk of bias in pediatric trials by using the Cochrane Risk of Bias tool. [7][8][9] The results are summarized in Table 1 by risk of bias domain. In 2 reviews, the overall risk of bias was unclear or high for the vast majority of trials. 7,8 Both of these articles also revealed that trials at high or unclear risk of bias had exaggerated treatment effects compared with those at low risk of bias. Sequence generation and allocation concealment appear to be the domains that are consistently problematic. Importantly, several variables have been found to be associated with risk of bias including source of funding (industry-sponsored research revealing higher risk of bias), nature of the interventions (behavioral/educational interventions having higher risk of bias), and number of authors (higher risk of bias with fewer authors). 9 These analyses demonstrate that there is substantial room for improvement in the methodological and reporting quality of pediatric trials. The association between risk of bias assessments and treatment effect estimates has important implications for decision-making both in terms of false-positive and false-negative results. In practice, this may result in unrealistic expectations of treatment benefit and safety. Inadequate reporting can also have an impact on systematic reviews, which are being used increasingly as a basis for informed decisionmaking. Although systematic reviews aim to be comprehensive and include all relevant studies, the number of studies contributing to various analyses, be they qualitative or quantitative, is often considerably smaller due to inadequate reporting.Ensuring methodological rigor and complete reporting is essential for informed clinical decision-making. It is critical that issues of bias are recognized and addressed by every person who conducts trials, reviews trials, funds trials, or uses trials to guide practice. This standards article was motivated by 2 key factors: (1) emerging evidence demonstrating methodological flaws a...

show abstract

“…Some patient-reported outcome instruments allow derivation and definition of multiple endpoints (ie, overall score at the end of the study, mean change of score during follow-up, percent change of baseline score) and a careful decision about the endpoint definition and anticipated magnitude of the effect size should be taken at the designing stage to avoid selective reporting of results and to assure appropriate power and sample size estimates. [36][37][38] Several initiatives have been established to develop and standardize patient-reported outcome measures. The Patient Reported Outcomes Measurement Information System (PROMIS) is a US National Institutes of Health-funded network of outcomes researchers with the overarching goal of developing a framework for patient-reported outcomes.…”

Section: Outcome Measuresmentioning

confidence: 99%

Clinical trial design in the era of comparative effectiveness research

Winter¹,

Colditz²

2014

OAJCT

View full text Add to dashboard Cite

Clinical trials are one of the key study designs in the evolving field of comparative effectiveness research. Evaluating the effectiveness of interventions in real-world settings is complex and demands a rethinking of the traditional clinical trial approach as well as transformation of the clinical trial landscape. Novel strategies and refinement of existing approaches have been proposed to generate evidence that can guide health care stakeholders in their decision process. The purpose of this review is to discuss clinical trial design approaches in the era of comparative effectiveness research. We will focus on aspects relevant to the type of clinical trial, study population and recruitment, randomization process, outcome measures, and data collection.

show abstract

Selective reporting in clinical trials: analysis of trial protocols accepted by The Lancet

Cited by 106 publications

References 5 publications

Dissemination and publication of research findings: an updated review of related biases

Dissemination and publication of research findings: an updated review of related biases

Standard 2: Containing Risk of Bias

Clinical trial design in the era of comparative effectiveness research

Contact Info

Product

Resources

About