Harmonisation of Outcome Parameters and Evaluation (HOPE) for actinic keratosis: protocol for the development of a core outcome set

Abstract Background Actinic keratoses (AK) are common skin lesions that can progress to invasive squamous cell carcinoma of the skin. A variety of lesion- or field-targeted treatment options exist and their efficacy has been demonstrated in numerous randomised controlled trials (RCTs). However, the reported endpoints are highly heterogeneous, making it difficult to assess and compare distinct treatment options and to reach an evidence-based choice of therapy. Methods A systematic literature search will be conducted to analyse which endpoints are reported in RCTs. The focus will be on effectiveness, tolerability, cosmesis, and patient satisfaction. The reported endpoints of these studies, as well as their frequency and data collection times, will be documented in a standardised way to generate a comprehensive list of reported endpoints. In order to complete the identified outcomes in the literature search, focus groups on affected patients and structured interviews with board-certified dermatologists will be conducted to identify both patient- and practice-relevant endpoints. After the identification phase, the evaluation of the endpoints follows. In a two-stage Delphi procedure, experts including patient representatives will evaluate the endpoints in a standardised and transparent manner. A final face-to-face consensus meeting will be conducted after the last Delphi round in which a final list of core outcomes will be consented. Discussion The development of a standardised endpoint set for the treatment of AK will contribute to improving the comparability of therapeutic options. Our catalogue will enhance the synthesis of evidence for the future by reducing heterogeneity in outcomes between RCTs and hence contribute to improving the quality of research, evidence-based and patient-centred treatment. Trial registration Core Outcome Measures for Effectiveness (COMET) database. Registered in December 2018.

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A protocol for developing a core outcome set for ectopic pregnancy

Trials ◽

10.1186/s13063-021-05772-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Krystle Y. Chong ◽

Sarah Solangon ◽

James Kemper ◽

Kurt Barnhart ◽

Pamela Causa Andrieu ◽

...

Keyword(s):

Ectopic Pregnancy ◽

Randomised Controlled Trials ◽

Core Outcome Set ◽

Future Research ◽

Controlled Trials ◽

Core Outcome ◽

Key Stakeholders ◽

Outcome Set ◽

Core Outcomes ◽

Randomised Controlled

Abstract Background Randomised controlled trials (RCTs) evaluating ectopic pregnancy have reported many different outcomes, which are themselves often defined and measured in distinct ways. This level of variation results in an inability to compare results of individual RCTs. The development of a core outcome set to ensure outcomes important to key stakeholders are collected consistently will guide future research in ectopic pregnancy. Study aim To develop and implement a core outcome set to guide future research in ectopic pregnancy. Methods and analysis We have established an international steering group of key stakeholders, including healthcare professionals, researchers, and individuals with lived experience of ectopic pregnancy. We will identify potential outcomes from ectopic pregnancy from a comprehensive literature review of published randomised controlled trials. We will then utilise a modified Delphi method to prioritise outcomes. Subsequently, key stakeholders will be invited to score potential core outcomes on a nine-point Likert scale, ranging from 1 (not important) to 9 (critical). Repeated reflection and rescoring should promote whole and individual stakeholder group convergence towards consensus ‘core’ outcomes. We will also establish standardised definitions and recommend high-quality measurements for individual core outcomes. Trial registration COMET 1492. Registered in November 2019.

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Systematic review of clinical outcome reporting in randomised controlled trials of burn care

BMJ Open ◽

10.1136/bmjopen-2018-025135 ◽

2019 ◽

Vol 9 (2) ◽

pp. e025135 ◽

Cited By ~ 4

Author(s):

Amber E Young ◽

Anna Davies ◽

Sophie Bland ◽

Sara Brookes ◽

Jane M Blazeby

Keyword(s):

Randomised Controlled Trials ◽

Core Outcome Set ◽

Controlled Trials ◽

Free Text ◽

Core Outcome ◽

Care Research ◽

Burn Care ◽

Outcome Reporting ◽

Outcome Set ◽

Randomised Controlled

IntroductionSystematic reviews collate trial data to provide evidence to support clinical decision-making. For effective synthesis, there must be consistency in outcome reporting. There is no agreed set of outcomes for reporting the effect of burn care interventions. Issues with outcome reporting have been identified, although not systematically investigated. This study gathers empirical evidence on any variation in outcome reporting and assesses the need for a core outcome set for burn care research.MethodsElectronic searches of four search engines were undertaken from January 2012 to December 2016 for randomised controlled trials (RCTs), using medical subject headings and free text terms including ‘burn’, ‘scald’ ‘thermal injury’ and ‘RCT’. Two authors independently screened papers, extracted outcomes verbatim and recorded the timing of outcome measurement. Duplicate outcomes (exact wording ± different spelling), similar outcomes (albumin in blood, serum albumin) and identical outcomes measured at different times were removed. Variation in outcome reporting was determined by assessing the number of unique outcomes reported across all included trials. Outcomes were classified into domains. Bias was reduced using five researchers and a patient working independently and together.Results147 trials were included, of which 127 (86.4%) were RCTs, 13 (8.8%) pilot studies and 7 (4.8%) RCT protocols. 1494 verbatim clinical outcomes were reported; 955 were unique. 76.8% of outcomes were measured within 6 months of injury. Commonly reported outcomes were defined differently. Numbers of unique outcomes per trial varied from one to 37 (median 9; IQR 5,13). No single outcome was reported across all studies demonstrating inconsistency of reporting. Outcomes were classified into 54 domains. Numbers of outcomes per domain ranged from 1 to 166 (median 11; IQR 3,24).ConclusionsThis review has demonstrated heterogeneity in outcome reporting in burn care research which will hinder amalgamation of study data. We recommend the development of a Core Outcome Set.PROSPERO registration numberCRD42017060908.

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Outcomes reported on the management of COPD exacerbations: a systematic survey of randomised controlled trials

ERJ Open Research ◽

10.1183/23120541.00072-2019 ◽

2019 ◽

Vol 5 (2) ◽

pp. 00072-2019 ◽

Cited By ~ 6

Author(s):

Alexander G. Mathioudakis ◽

Mia Moberg ◽

Julie Janner ◽

Pablo Alonso-Coello ◽

Jørgen Vestbo

Keyword(s):

Outcome Measures ◽

Systematic Reviews ◽

Randomised Controlled Trials ◽

Core Outcome Set ◽

Controlled Trials ◽

Significant Heterogeneity ◽

Core Outcome ◽

Copd Exacerbations ◽

Outcome Set ◽

Randomised Controlled

Randomised controlled trials (RCTs) evaluating the management of acute exacerbations of chronic obstructive pulmonary disease (COPD) report heterogeneous outcome measures, thus rendering their results incomparable, complicating their translation into clinical practice. As a first step in the development of a core outcome set that will aim to homogenise outcome measures in future RCTs, we assessed the outcomes reported in recent relevant RCTs and systematic reviews.We conducted a methodological systematic review (https://www.crd.york.ac.uk/prospero/ registration number CRD42016052437) of RCTs and systematic reviews on COPD exacerbation management indexed on Medline and PubMed during the last decade. We evaluated their methodology, specifically focusing on the reported outcome measures.Based on 123 RCTs and 38 systematic reviews, we found significant variability in the outcomes reported and in their definition. Mortality, which was assessed in 82% of the included trials, was the most frequently assessed outcome, followed by the rate of treatment success or failure (63%), adverse events (59%), health status, symptoms and quality of life (59%), lung function (47%), and duration of exacerbations (42%).The significant heterogeneity in the selection and definition of outcome measures in RCTs and systematic reviews limits the interpretability and comparability of their results, and warrants the development of a core outcome set for COPD exacerbations management.

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Relationship between xerosis and pruritus in patients with chronic kidney disease

Postępy Higieny i Medycyny Doświadczalnej ◽

10.5604/01.3001.0010.7614 ◽

2017 ◽

Vol 71 (0) ◽

pp. 0-0

Author(s):

Katarzyna Kiliś-Pstrusińska ◽

Elżbieta Wojtowicz-Prus ◽

Jacek Szepietowski

Keyword(s):

Chronic Kidney Disease ◽

Kidney Disease ◽

Kidney Diseases ◽

Treatment Options ◽

Skin Lesions ◽

Chronic Kidney Diseases ◽

Skin Changes ◽

Uremic Pruritus ◽

Common Skin

Xerosis and pruritus are the most common skin disorders in patients with chronic kidney diseases (CKD). The prevalence and intensity of those skin changes are higher in patients undergoing dialysis, independent of its type, compared to patients treated conservatively. However, they can occur even in the early stages of CKD and be very bothersome for the sufferers. The problem of dry skin in CKD patients, its characteristics, reasons and relationship between xerosis and pruritus have been described. The current views on the pathogenesis of chronic kidney disease-associated pruritus (CKD-P), formerly known as uremic pruritus, have been discussed. This article summarizes the available treatment options for CKD-P, including both topical and systemic therapies. The authors direct attention to the need for skin lesions treatment in order to prevent their progression and to improve the quality of patients’ life.

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Treatment of Chronic Pulmonary Heart Disease with Traditional Chinese Medicine: A Protocol for the Development of a Core Outcome Set (COS-TCM-CPHD)

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/5559883 ◽

2021 ◽

Vol 2021 ◽

pp. 1-7

Author(s):

Bohan Niu ◽

Mingyan Zhang ◽

Hui Zi Chua ◽

Kai Li ◽

Junhua Zhang

Keyword(s):

Decision Making ◽

Heart Disease ◽

Core Outcome Set ◽

Evidence Based ◽

Core Outcome ◽

Stakeholder Groups ◽

Pulmonary Heart Disease ◽

Outcome Set ◽

Chronic Pulmonary Heart Disease

Background. Treatment of chronic pulmonary heart disease (CPHD), a common disease, has over recent years been studied using traditional Chinese medicine (TCM) due to many high-profile benefits. These can be evaluated by the measurement and analysis of related outcomes. Because of selective reporting bias and the heterogeneity of study outcomes, it is not possible to combine similar studies in a meta-analysis. Consequently, not only does the low quality of original studies fails to support evidence-based decision-making, but also the value of those clinical studies cannot be evaluated. To solve these problems, the development of a core outcome set for traditional Chinese medicines for the treatment of chronic pulmonary heart disease (COS-TCM-CPHD) is required. Methods. The development is conducted in five steps: (1) a library of outcomes through systematic review, the retrieval of libraries from two clinical trials registries, and semistructured interviews is established; (2) following data extraction and analysis of the library of outcomes, each outcome can be classified into seven outcome domains, including TCM disease, symptoms/signs, physical and chemical testing, quality of life, long-term prognosis, economic evaluation, and adverse events to form a preliminary list of outcomes; (3) stakeholder groups for participation are selected; (4) stakeholder groups are invited to participate in two rounds of Delphi surveys to score outcomes and provide additional outcomes; (5) a consensus meeting is organized to produce the final COS-TCM-CPHD. Discussion. The protocol is consistent with the guidelines defined by the Core Outcome Set-STAndardised Protocol (COS-STAP) statement and formulated with reference to Core Outcome Set-STAndards for development (COS-STAD). The COS-TCM-CPHD will improve the consistency of study reports and reduce publication bias, thereby improving the quality of TCM clinical trials and decision-making for evidence-based medicine. The study has been registered on the COMET website (http://www.comet-initiative.org/Studies/Details/1677).

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Pharmacologic Treatment Options for Insomnia in Patients with Schizophrenia

Medicines ◽

10.3390/medicines5030088 ◽

2018 ◽

Vol 5 (3) ◽

pp. 88 ◽

Cited By ~ 4

Author(s):

Lauren Stummer ◽

Marija Markovic ◽

Megan Maroney

Keyword(s):

Sleep Disturbances ◽

Literature Search ◽

Treatment Options ◽

Sodium Oxybate ◽

Controlled Trials ◽

Evidence Based ◽

Pharmacologic Treatment ◽

Search Results ◽

Randomized Controlled ◽

Second Generation Antipsychotic

Background: Symptoms of sleep disorders, such as disturbances in sleep initiation and continuity, are commonly reported in patients with schizophrenia, especially in the acute phase of illness. Studies have shown that up to 80% of patients diagnosed with schizophrenia report symptoms of insomnia. Sleep disturbances have been shown to increase the risk of cognitive dysfunction and relapse in patients with schizophrenia. Currently, there are no medications approved specifically for the treatment of insomnia in patients with schizophrenia. Methods: A literature search was performed through OVID and PubMed to compile publications of pharmacotherapy options studied to treat insomnia in patients with schizophrenia. Articles were reviewed from 1 January 2000 through 1 March 2018 with some additional earlier articles selected if deemed by the authors to be particularly relevant. Results: Pharmacotherapies collected from the search results that were reviewed and evaluated included melatonin, eszopiclone, sodium oxybate, and antipsychotics. Conclusions: Overall, this review confirmed that there are a few evidence-based options to treat insomnia in patients with schizophrenia, including selecting a more sedating second-generation antipsychotic such as paliperidone, or adding melatonin or eszopiclone. Further randomized controlled trials are needed.

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A systematic review of the outcomes reported in Cardiac arrest randomised controlled trials: The need for a core outcome set

Resuscitation ◽

10.1016/j.resuscitation.2013.08.129 ◽

2013 ◽

Vol 84 ◽

pp. S50

Author(s):

Laura Whitehead ◽

Gavin Perkins ◽

Andrew Clarey ◽

Kirstie Haywood

Keyword(s):

Systematic Review ◽

Cardiac Arrest ◽

Randomised Controlled Trials ◽

Core Outcome Set ◽

Controlled Trials ◽

Core Outcome ◽

Outcome Set ◽

Randomised Controlled

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Outcomes in randomised controlled trials of multifocal lenses in cataract surgery: the case for development of a core outcome set

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2019-315410 ◽

2020 ◽

Vol 104 (10) ◽

pp. 1345-1349

Author(s):

Jennifer R Evans ◽

Samantha R de Silva ◽

Mohammed Ziaei ◽

Varo Kirthi ◽

Martin D Leyland

Keyword(s):

Cataract Surgery ◽

Outcome Measures ◽

Randomised Controlled Trials ◽

Core Outcome Set ◽

Intraocular Lenses ◽

Controlled Trials ◽

Core Outcome ◽

Outcome Set ◽

Patient Reported ◽

Randomised Controlled

Background/aimsTo describe and summarise the outcomes reported in randomised controlled trials of multifocal versus monofocal intraocular lenses in cataract surgery.MethodsWe identified all randomised controlled trials of multifocal versus monofocal lenses in a Cochrane review (last search date June 2016). We extracted and summarised data on all outcomes reported using the framework of domain, measurement, metric and method of aggregation.ResultsAll studies collected data on distance and near visual acuity but there was considerable variation in the measures used and whether these outcomes were unaided or best corrected. Most studies reported final value measurements, rather than change from baseline. Approximately half of the studies reported data as a continuous measure only, one-third reported both continuous and categorical measures and a minority reported categorical measures only. There was little consensus as to cut-points. Although a majority of studies included one or more patient-reported outcome measures, none of the studies reported patient involvement in the choice of outcomes.ConclusionThe collection and analysis of data on outcome measures in studies of multifocal intraocular lenses in cataract surgery are complicated. As a result, there is considerable heterogeneity in collection and reporting in the medical literature. This makes it difficult to synthesise such data to provide robust estimates of effect and is a potential source of research waste. Investigators in this field must produce a core outcome set that is informed by patients’ views and we propose an initial set of outcomes on which these could be based.

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