Results availability for analgesic device, complex regional pain syndrome, and post-stroke pain trials

Dufka, Faustine L.; Munch, Troels; Dworkin, Robert H.

doi:10.1016/j.pain.0000000000000009

Cited by 7 publications

(5 citation statements)

References 54 publications

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“…One theme in this group included standards for dissemination including open databases for sharing study-related materials, standards for reporting results and sharing study documentation, and standards for registering studies and complying with regulatory requirements [92][93][94][95]. Another group examined how to assess the availability of study results, readability of study descriptions, and potential impact of a study using bibiliometrics [96][97][98]. Two papers described informatics methods for the dissemination of research to broader audiences, seeking to improve public understanding, government support for research, and policy makers awareness [99,100].…”

Section: Communicating Study Resultsmentioning

confidence: 99%

Clinical Research Informatics: Supporting the Research Study Lifecycle

Johnson¹

2017

Yearb Med Inform

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SummaryObjectives: The primary goal of this review is to summarize significant developments in the field of Clinical Research Informatics (CRI) over the years [2015][2016]. The secondary goal is to contribute to a deeper understanding of CRI as a field, through the development of a strategy for searching and classifying CRI publications. Methods: A search strategy was developed to query the PubMed database, using medical subject headings to both select and exclude articles, and filtering publications by date and other characteristics. A manual review classified publications using stages in the "research study lifecycle", with key stages that include study definition, participant enrollment, data management, data analysis, and results dissemination. Results: The search strategy generated 510 publications. The manual classification identified 125 publications as relevant to CRI, which were classified into seven different stages of the research lifecycle, and one additional class that pertained to multiple stages, referring to general infrastructure or standards. Important cross-cutting themes included new applications of electronic media (Internet, social media, mobile devices), standardization of data and procedures, and increased automation through the use of data mining and big data methods. Conclusions: The review revealed increased interest and support for CRI in large-scale projects across institutions, regionally, nationally, and internationally. A search strategy based on medical subject headings can find many relevant papers, but a large number of non-relevant papers need to be detected using text words which pertain to closely related fields such as computational statistics and clinical informatics. The research lifecycle was useful as a classification scheme by highlighting the relevance to the users of clinical research informatics solutions.

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Section: Communicating Study Resultsmentioning

confidence: 99%

Clinical Research Informatics: Supporting the Research Study Lifecycle

Johnson¹

2017

Yearb Med Inform

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“…We included studies that identified adult participants aged 18 years or older who had 1 or more chronic NP conditions, classified according to the IASP classification of chronic neuropathic pain for ICD-11. 43 Conditions included (1) painful cancer-related neuropathy or chemotherapy-induced peripheral neuropathy, (2) painful HIV neuropathy, (3) painful diabetic neuropathy, (4) phantom limb pain, (5) postherpetic neuralgia, (6) postoperative or traumatic NP, (7) painful polyneuropathy, (8) lumbar radiculopathy, (9) mixed NP, (10) spinal cord injury, (11) poststroke pain, and (12) pain associated with multiple sclerosis (Appendix 1, http://links.lww.com/PAIN/B455).…”

Section: Methodsmentioning

confidence: 99%

“…5 Various reporting biases, such as publication bias, outcome reporting bias, and citation bias, have received considerable attention in clinical medicine, including pain. 10,19,41 Citation bias occurs when studies with statistically significant results are cited more frequently than those with nonsignificant results. 2,9,12 Reporting bias may result in an overappraisal of an intervention's benefit 34 and may impact the results of pooled assessments in systematic reviews and meta-analyses.…”

Section: Introductionmentioning

confidence: 99%

“…18 Although studies of reporting bias are ubiquitous in the biomedical literature, comprehensive studies of reporting bias in the pain field are lacking. 10,41 We sought to determine whether reporting bias exists in the literature related to chronic neuropathic pain (NP), defined as pain caused by a lesion or disease of the somatosensory system. 15,24 Epidemiological studies suggest that 7% to 8% of the adult population may experience NP.…”

Section: Introductionmentioning

confidence: 99%

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Pharmacologic therapies for neuropathic pain: an assessment of reporting biases in randomized controlled trials

Schwartz

Barpujari²,

Finnerup³

et al. 2021

Pain

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Several different reporting biases cited in scientific literature have raised concerns about the overestimation of effects and the subsequent potential impact on the practice of evidence-based medicine and human health. Up to 7% to 8% of the population experiences neuropathic pain (NP), and established treatment guidelines are based predominantly on published clinical trial results. Therefore, we examined published randomized controlled trials (RCTs) of first-line drugs for NP and assessed the relative proportions with statistically significant (ie, positive) and nonsignificant (ie, negative) results and their rates of citation. We determined the relationships between reported study outcome and the frequency of their citations with journal impact factor, sample size, time to publication after study completion, and study quality metrics. We also examined the association of study outcome with maximum study drug dosage and conflict of interest. We found that of 107 published RCTs, 68.2% reported a statistically significant outcome regarding drug efficacy for chronic peripheral and central NP. Positive studies were cited nearly twice as often as negative studies in the literature (P 5 0.01), despite similar study sample size, quality metrics, and publication in journals with similar impact factors. The time to publication, journal impact factor, and conflict of interest did not differ statistically between positive and negative studies. Our observations that negative and positive RCTs were published in journals with similar impact at comparable time-lags after study completion are encouraging. However, the citation bias for positive studies could affect the validity and generalization of conclusions in literature and potentially influence clinical practice.

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“…5 In the pain literature, the RReACT, RReMiT, and RReADS databases took a snapshot and scorecard approach to clinical trials of drugs for chronic pain and migraine, and trials of analgesic devices. 7,19 The snapshot was a database of all clinical trials on CTG and other trials registries and the scorecard was the proportion of completed clinical trials that had results publicly available through posting on a registry, through press release or other documents available through an internet search, or through a peer-reviewed journal publication. Examining almost 1000 trials across a spectrum of painful disorders (fibromyalgia, diabetic painful neuropathy, postherpetic neuralgia, migraine, complex regional pain syndrome, and central poststroke pain) and types of treatment revealed no single study characteristic that consistently predicted unavailability of results.…”

Section: Enhancing Transparency In the Pain Literature—rreact Rrementioning

confidence: 99%

Ethical considerations in the design, execution, and analysis of clinical trials of chronic pain treatments

McDermott

2019

PR9

Self Cite

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Introduction:In the field of pain research, clinical trials may randomize over 500 subjects and include more than 150 sites spanning over a dozen countries.Methods:This review examines the ethical considerations affecting clinical trial design, execution, and analysis of trials for chronic pain. The Belmont Report has been the touchstone for human studies protection efforts since 1979. Commissioned by the U.S. government in response to ethical failures in medical research, such as the Tuskegee Syphilis Study, the report emphasizes 3 basic principles: respect for persons, beneficence, and justice. Trial design and sample size have important ethical implications.Conclusions:Measures to enhance trial transparency and combat publication and many other types of bias should be implemented.

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Results availability for analgesic device, complex regional pain syndrome, and post-stroke pain trials

Abstract: Supplemental Digital Content is Available in the Text.Fewer than half of registered complex regional pain syndrome, post-stroke pain, and analgesic device trials have available results. No single study characteristic predicts unavailability. Practical remedies are available.

Cited by 7 publications

References 54 publications

Clinical Research Informatics: Supporting the Research Study Lifecycle

Clinical Research Informatics: Supporting the Research Study Lifecycle

Pharmacologic therapies for neuropathic pain: an assessment of reporting biases in randomized controlled trials

Ethical considerations in the design, execution, and analysis of clinical trials of chronic pain treatments

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