THU0528 NAILFOLD VIDEOCAPILLAROSCOPY REPORTING IN CLINICAL RESEARCH: INTERNATIONAL DELPHI BASED CONSENSUS

Background:Nailfold capillaroscopy (NVC), a non-invasive technique to assess microcirculation, is increasingly being incorporated into rheumatology routine clinical practice. Currently, the degree of description of NVC methods varies amongst research studies, making interpretation and comparison between studies challenging. In this field, an unmet need is the standardization of items to be reported in research studies using NVC.Objectives:To perform a Delphi consensus on minimum reporting standards in methodology for clinical research, based on the items derived from a systematic review focused on this topic.Methods:The systematic review of the literature on NVC methodology relating to rheumatic diseases was performed according to PRISMA guidelines (PROSPERO CRD42018104660) to July 22nd2018 using MEDLINE, Embase, Scopus. Then, a three-step web-based Delphi consensus was performed in between members of the EULAR study group on microcirculation in rheumatic diseases and the Scleroderma Clinical Trials Consortium. Participants were asked to rate each item from 1 (not appropriate) to 9 (completely appropriate).Results:In total, 3491 references were retrieved in the initial search strategy, 2862 were excluded as duplicates or after title/abstract screening. 632 articles were retrieved for full paper review of which 319 fulfilled the inclusion criteria. Regarding patient preparation before the exam, data were scarce: 38% reported acclimatization, 5% to avoid caffeine and smoking, 3% to wash hands and 2% to avoid manicure. Concerning the device description: 90% reported type of instrument, 77% brand/model, 72% magnification, 46% oil use, 40% room temperature and 35% software for image analysis. As regards to examination details: 76% which fingers examined, 75% number of fingers examined, 15% operator experience, 13% reason for finger exclusion, 9% number of images, 8% quality check of the images and 3% time spent for the exam. Then, a three-round Delphi consensus on the selected items was completed by 80 participants internationally, from 31 countries located in Australia, Asia, Europe, North and South America. Some items reached the agreement at the second round (85 participants), and other items were suggested as important to consider in a future research agenda (e.g. temperature for acclimatization, the impact of smoking, allergies at the application of the oil to the nailbed, significance of pericapillary edema, methods of reporting hemorrhages, ramified and giant capillaries). The final agreement results are reported below:Conclusion:On the basis of the available literature the description of NVC methods was highly heterogeneous and individual published studies differed markedly. These practical suggestions developed using a Delphi process among international participants provide a guidance to improve and to standardize the NVC methodology in future clinical research studies.Disclosure of Interests:Francesca Ingegnoli: None declared, Tommaso Schioppo: None declared, Ariane Herrick: None declared, Alberto Sulli Grant/research support from: Laboratori Baldacci, Francesca Bartoli: None declared, Nicola Ughi: None declared, John Pauling: None declared, Maurizio Cutolo Grant/research support from: Bristol-Myers Squibb, Actelion, Celgene, Consultant of: Bristol-Myers Squibb, Speakers bureau: Sigma-Alpha, Vanessa Smith Grant/research support from: The affiliated company received grants from Research Foundation - Flanders (FWO), Belgian Fund for Scientific Research in Rheumatic diseases (FWRO), Boehringer Ingelheim Pharma GmbH & Co and Janssen-Cilag NV, Consultant of: Boehringer-Ingelheim Pharma GmbH & Co, Speakers bureau: Actelion Pharmaceuticals Ltd, Boehringer-Ingelheim Pharma GmbH & Co and UCB Biopharma Sprl

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Reporting items for capillaroscopy in clinical research on musculoskeletal diseases: a systematic review and international Delphi consensus

Rheumatology ◽

10.1093/rheumatology/keaa457 ◽

2020 ◽

Author(s):

Francesca Ingegnoli ◽

Ariane L Herrick ◽

Tommaso Schioppo ◽

Francesca Bartoli ◽

Nicola Ughi ◽

...

Keyword(s):

Systematic Review ◽

Clinical Research ◽

Rheumatic Diseases ◽

Musculoskeletal Diseases ◽

Delphi Process ◽

Reporting Standards ◽

Delphi Consensus ◽

Delphi Exercise ◽

Patient Preparation ◽

Research Studies

Abstract Objectives The level of detail included when describing nailfold videocapillaroscopy (NVC) methods varies among research studies, making interpretation and comparison of results challenging. The overarching objective of the present study was to seek consensus on the reporting standards in NVC methodology for clinical research in rheumatic diseases and to propose a pragmatic reporting checklist. Methods Based on the items derived from a systematic review focused on this topic, a three-step web-based Delphi consensus on minimum reporting standards in NVC was performed among members of the European League against Rheumatism (EULAR) Study Group on Microcirculation in Rheumatic Diseases and the Scleroderma Clinical Trials Consortium. Results A total of 319 articles were selected by the systematic review, and 46 items were proposed in the Delphi process. This Delphi exercise was completed by 80 participants from 31 countries, including Australia and countries within Asia, Europe, North America and South America. Agreement was reached on items covering three main areas: patient preparation before NVC (15 items), device description (5 items) and examination details (13 items). Conclusion Based on the available evidence, the description of NVC methods was highly heterogeneous in the identified studies and differed markedly on several items. A reporting checklist of 33 items, based on practical suggestions made (using a Delphi process) by international participants, has been developed to provide guidance to improve and standardize the NVC methodology to be applied in future clinical research studies.

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A systematic review exploring the bidirectional relationship between puberty and autoimmune rheumatic diseases

10.21203/rs.3.rs-45432/v1 ◽

2020 ◽

Author(s):

Nina M de Gruijter ◽

Meena Naja ◽

Hannah Peckham ◽

Anna Radziszewska ◽

Matthew Kinsella ◽

...

Keyword(s):

Systematic Review ◽

Rheumatic Diseases ◽

Lupus Erythematosus ◽

Meta Analysis ◽

Severe Disease ◽

Delayed Puberty ◽

Future Research ◽

Autoimmune Rheumatic Diseases ◽

Bidirectional Relationship ◽

The Impact

Abstract Background: Autoimmune rheumatic diseases (ARDs) are associated with a significant sex-bias which becomes more evident post-puberty. This systematic review aims to elucidate the bidirectional relationship between puberty and ARDs related outcomes.Methods: Studies published in English until October 2019 were identified using a systematic search of endocrinology and rheumatology literature. Information was extracted on study design, sample size, demographics, puberty outcome measures, and main findings. The methodological quality of the studies included was analysed using the Newcastle-Ottawa Scale (NOS).Results: 14 non-randomised studies reporting on the impact of puberty on ARD outcomes (n = 7), ARD impact on puberty-related outcomes (n = 6), or both (n = 1) have been identified. The impact of puberty on ARD outcomes have been investigated in patients with juvenile idiopathic arthritis (JIA)-associated uveitis (n = 1), juvenile systemic lupus erythematosus (JSLE) (n = 5) or in healthy controls who developed adult-onset SLE (n = 1) or had non-specific symptoms (n = 1). The impact of ARD on puberty outcomes was explored in JIA (n = 4) and JSLE (n = 3). Quality assessment of studies showed a small to moderate risk of bias overall (NOS 4–9/9). Due to large heterogeneity of the studies it was not possible to perform a meta-analysis. Multiple studies reported on delayed puberty in patients with JIA/JSLE, menstrual and hormonal abnormalities, and lower height and weight than controls. Earlier (pre-pubertal) onset of JSLE was correlated with more severe disease and more need for systemic treatment.Conclusion: A bidirectional relationship exists between puberty and ARDs; however, more and better research is required to elucidate the complexity of this relationship. We propose puberty-related clinical assessments in patients with ARDs, which can improve patient outcomes and facilitate future research.

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Forty Years of Rape Myth Acceptance Interventions: A Systematic Review of What Works in Naturalistic Institutional Settings and How this can be Applied to Educational Guidance for Jurors

Trauma Violence & Abuse ◽

10.1177/15248380211050575 ◽

2021 ◽

pp. 152483802110505

Author(s):

Lara F. Hudspith ◽

Nadia Wager ◽

Dominic Willmott ◽

Bernard Gallagher

Keyword(s):

Systematic Review ◽

Rape Myth Acceptance ◽

Rape Myth ◽

Institutional Setting ◽

Future Research ◽

Policy And Practice ◽

Institutional Settings ◽

The Impact ◽

Research Studies ◽

Myth Acceptance

A systematic review of research assessing rape myth acceptance (RMA) interventions within institutional settings was conducted. The aim of this review was to inform the development of an educational intervention for jurors in rape trials that addresses rape myths, given previous evidence that RMA can affect decision-making and verdicts (Dinos et al., 2015; Gravelin et al., 2019; Leverick, 2020). 12 databases were searched, filtered to return peer-reviewed journals, published from 1980 to 2020, written in English. After removing duplicates from the 5,093 search results returned, 2,676 studies were screened for inclusion. Research studies were included in the review if they assessed the impact of a naturalistic intervention on RMA within an institutional setting. Studies that did not compare an experimental condition to a control condition or did not randomly allocate participants to conditions were excluded. Studies were also excluded if they used a non-validated, or adapted, RMA measure. 20 Research studies were included within the review and were critically appraised according to an author-created critical appraisal tool. It was concluded that RMA interventions can have a short-term impact upon individuals' RMA. Intervention types that were effective in reducing RMA included those that presented RM information; those that contained an empathy component; and bystander programmes. With regards to duration and format, short interventions led to reductions in RMA, and most successful interventions were presented via videos. Implications for policy and practice, and recommendations for future research, are discussed.

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A systematic review exploring the bidirectional relationship between puberty and autoimmune rheumatic diseases

10.21203/rs.3.rs-45432/v2 ◽

2020 ◽

Author(s):

Nina M de Gruijter ◽

Meena Naja ◽

Hannah Peckham ◽

Anna Radziszewska ◽

Matthew Kinsella ◽

...

Keyword(s):

Systematic Review ◽

Outcome Measures ◽

Rheumatic Diseases ◽

Lupus Erythematosus ◽

Severe Disease ◽

Delayed Puberty ◽

Future Research ◽

Autoimmune Rheumatic Diseases ◽

Bidirectional Relationship ◽

The Impact

Abstract BackgroundAutoimmune rheumatic diseases (ARDs) are associated with a significant sex-bias, which becomes more evident post-puberty. This systematic review aims to elucidate the bidirectional relationship between puberty and ARD-related outcomes.MethodsStudies published in English until October 2019 were identified using a systematic search of endocrinology and rheumatology literature. Information was extracted on study design, sample size, demographics, puberty outcome measures, disease outcome measures, and main findings. The methodological quality of the studies included was analysed using the Newcastle-Ottawa Scale (NOS).Results16 non-randomised studies reporting on the impact of puberty on ARD outcomes (n=7), ARD impact on puberty-related outcomes (n=8), or both (n=1) have been identified. The impact of puberty on ARD outcomes were investigated in patients with juvenile idiopathic arthritis (JIA)-associated uveitis (n=1), juvenile systemic lupus erythematosus (JSLE) (n=5) or in healthy controls who developed adult-onset SLE (n=1) or had non-specific symptoms (n=1). The impact of ARD on puberty outcomes was explored in JIA (n=4) and JSLE (n=3). Quality assessment of studies showed a small to moderate risk of bias overall (NOS 4-9/9). Due to large heterogeneity of the studies it was not possible to perform a meta-analysis. Multiple studies reported on delayed puberty in patients with JIA/JSLE, menstrual and hormonal abnormalities, and lower height and weight than controls. Earlier (pre-pubertal) onset of JSLE was correlated with more severe disease and more need for systemic treatment.ConclusionA bidirectional relationship exists between puberty and ARDs; however, more and better research is required to elucidate the complexity of this relationship. We propose puberty-related clinical assessments in patients with ARDs, which can improve patient outcomes and facilitate future research.

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Does Altruism Affect Participation in Cancer Research? A Systematic Review

10.21203/rs.3.rs-1017250/v1 ◽

2021 ◽

Author(s):

Danny HJ Heo ◽

M. Juanita Rodriguez ◽

Megan McNichol ◽

A. James Moser

Keyword(s):

Systematic Review ◽

Cancer Research ◽

Clinical Research ◽

Cancer Patients ◽

Social Exchange ◽

Published Data ◽

Structured Interviews ◽

Eligibility Criteria ◽

The Impact ◽

Research Studies

Abstract Background: The impact of altruism on enrollment and longitudinal follow-up among cancer patients participating in clinical research studies remains poorly understood. This systematic review assesses published data reporting altruism as a motivator in cancer research and derives objective definitions of the four subtypes of altruism to permit future investigation in prospective therapeutic and non-therapeutic studies.Method: A qualitative systematic review of altruism and cancer was conducted according PRISMA after a literature search of PubMed, Embase, Cochrane, and PsychINFO databases. Study aims, methodology, outcomes, and conclusions were extracted to perform qualitative analysis of altruistic motivations among cancer research participants. Quality and risk of bias were assessed using the Joanna Briggs Institute (JBI) Critical Appraisal tool for Systematic Reviews Checklist for Qualitative Research. Results: Of 78 full-text manuscripts, fourteen met eligibility criteria for analysis, all of which used semi-structured interviews or questionnaires to study subsets of cancer patients participating in therapeutic clinical trials or non-therapeutic biobanking. Four distinct subtypes of altruism were demonstrated and defined according to an association map having the following four domains: personal benefit, benefit to family (kinship), benefit to others, and social exchange. Conclusion: Different types of altruism among cancer patients were observed both in therapeutic and non-therapeutic studies. Altruism remains as an underrecognized factor that affects clinical research studies.

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A systematic review exploring the bidirectional relationship between puberty and autoimmune rheumatic diseases

Pediatric Rheumatology ◽

10.1186/s12969-021-00528-y ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Nina M. de Gruijter ◽

Meena Naja ◽

Hannah Peckham ◽

Anna Radziszewska ◽

Matthew Kinsella ◽

...

Keyword(s):

Systematic Review ◽

Outcome Measures ◽

Rheumatic Diseases ◽

Lupus Erythematosus ◽

Severe Disease ◽

Delayed Puberty ◽

Future Research ◽

Autoimmune Rheumatic Diseases ◽

Bidirectional Relationship ◽

The Impact

Abstract Background Autoimmune rheumatic diseases (ARDs) are associated with a significant sex-bias, which becomes more evident post-puberty. This systematic review aims to elucidate the bidirectional relationship between puberty and ARD-related outcomes. Methods Studies published in English until October 2019 were identified using a systematic search of endocrinology and rheumatology literature. Information was extracted on study design, sample size, demographics, puberty outcome measures, disease outcome measures, and main findings. The methodological quality of the studies included was analysed using the Newcastle-Ottawa Scale (NOS). Results Sixteen non-randomised studies reporting on the impact of puberty on ARD outcomes (n = 7), ARD impact on puberty-related outcomes (n = 8), or both (n = 1) have been identified. The impact of puberty on ARD outcomes were investigated in patients with juvenile idiopathic arthritis (JIA)-associated uveitis (n = 1), juvenile systemic lupus erythematosus (JSLE) (n = 5) or in healthy controls who developed adult-onset SLE (n = 1) or had non-specific symptoms (n = 1). The impact of ARD on puberty outcomes was explored in JIA (n = 4) and JSLE (n = 3). Quality assessment of studies showed a small to moderate risk of bias overall (NOS 4–9/9). Due to large heterogeneity of the studies it was not possible to perform a meta-analysis. Multiple studies reported on delayed puberty in patients with JIA/JSLE, menstrual and hormonal abnormalities, and lower height and weight than controls. Earlier (pre-pubertal) onset of JSLE was correlated with more severe disease and more need for systemic treatment. Conclusion A bidirectional relationship exists between puberty and ARDs; however, more and better research is required to elucidate the complexity of this relationship. We propose puberty-related clinical assessments in patients with ARDs, which can improve patient outcomes and facilitate future research.

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A systematic review of criteria used to report complications in soft tissue and oncologic surgical clinical research studies in dogs and cats

Veterinary Surgery ◽

10.1111/vsu.13279 ◽

2019 ◽

Vol 49 (1) ◽

pp. 61-69 ◽

Cited By ~ 4

Author(s):

Christelle M. Follette ◽

Michelle A. Giuffrida ◽

Ingrid M. Balsa ◽

William T. N. Culp ◽

Philipp D. Mayhew ◽

...

Keyword(s):

Systematic Review ◽

Soft Tissue ◽

Clinical Research ◽

Research Studies

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Quality of life in primary sclerosing cholangitis: a systematic review

Health and Quality of Life Outcomes ◽

10.1186/s12955-021-01739-3 ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Elena Marcus ◽

Paddy Stone ◽

Anna-Maria Krooupa ◽

Douglas Thorburn ◽

Bella Vivat

Keyword(s):

Quality Of Life ◽

Systematic Review ◽

Clinical Research ◽

Disease Progression ◽

Primary Sclerosing Cholangitis ◽

Sclerosing Cholangitis ◽

Small Sample ◽

Limited Evidence ◽

Research Studies

Abstract Background Primary sclerosing cholangitis (PSC) is a rare bile duct and liver disease which can considerably impact quality of life (QoL). As part of a project developing a measure of QoL for people with PSC, we conducted a systematic review with four review questions. The first of these questions overlaps with a recently published systematic review, so this paper reports on the last three of our initial four questions: (A) How does QoL in PSC compare with other groups?, (B) Which attributes/factors are associated with impaired QoL in PSC?, (C) Which interventions are effective in improving QoL in people with PSC?. Methods We systematically searched five databases from inception to 1 November 2020 and assessed the methodological quality of included studies using standard checklists. Results We identified 28 studies: 17 for (A), ten for (B), and nine for (C). Limited evidence was found for all review questions, with few studies included in each comparison, and small sample sizes. The limited evidence available indicated poorer QoL for people with PSC compared with healthy controls, but findings were mixed for comparisons with the general population. QoL outcomes in PSC were comparable to other chronic conditions. Itch, pain, jaundice, severity of inflammatory bowel disease, liver cirrhosis, and large-duct PSC were all associated with impaired QoL. No associations were found between QoL and PSC severity measured with surrogate markers of disease progression or one of three prognostic scoring systems. No interventions were found to improve QoL outcomes. Conclusion The limited findings from included studies suggest that markers of disease progression used in clinical trials may not reflect the experiences of people with PSC. This highlights the importance for clinical research studies to assess QoL alongside clinical and laboratory-based outcomes. A valid and responsive PSC-specific measure of QoL, to adequately capture all issues of importance to people with PSC, would therefore be helpful for clinical research studies.

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Abstract NS6: To Rest or Mobilize... When to Start Early Mobilization in Acute Stroke: a Systematic Review

Stroke ◽

10.1161/str.47.suppl_1.ns6 ◽

2016 ◽

Vol 47 (suppl_1) ◽

Author(s):

Michelle Whaley ◽

Wendy Dusenbury ◽

Andrei V Alexandrov ◽

Georgios Tsivgoulis ◽

Anne W Alexandrov

Keyword(s):

Systematic Review ◽

Ischemic Stroke ◽

Acute Stroke ◽

Early Mobilization ◽

Future Research ◽

Cochrane Central Register ◽

Large Artery ◽

Stroke Subtype ◽

Vascular Insufficiency ◽

The Impact

Background: Recent nursing initiatives encourage early mobilization of neurocritical care patients, but whether this intervention can be safely generalized to acute stroke is debatable. We performed a systematic review of findings from recent studies to provide direction for patient management and future research. Methods: An exhaustive literature search was performed in Medline, SCOPUS and the Cochrane Central Register of Controlled Trials to identify published clinical trial research using a very early mobility intervention (within 24 hours) in acute ischemic stroke patients. The primary efficacy outcome supporting the search was neurologic disability reduction or improved functional outcomes, and the primary safety outcome was neurologic deterioration. Studies were critically reviewed for inclusion by 3 separate investigators, findings were synthesized, and an overall recommendation for very early mobilization use in acute stroke was assigned according to GRADE criteria. Results: We initially identified 12 papers focused on early mobilization in acute stroke; of these, 6 observational studies were excluded, 1 study was excluded due to an ambiguous population, and 3 studies were excluded due to first initial mobilization out of bed occurring greater than 24 hours after admission. Two prospective randomized outcome blinded evaluation (PROBE) studies were retained, consisting of a total 2160 patients; ischemic stroke subtype was not disclosed in either study, limiting an understanding of the impact of very early mobilization on small versus large artery occlusion. Slower mobilization occurring beyond the first 24 hours was associated with higher rates of favorable outcome (mRS 0-2) at 90 days, whereas very early mobilization within the first 24 hours was associated with a number needed to harm of 25. Conclusions: In acute stroke, evidence supports a rested approach to care within the first 24 hours of hospitalization (GRADE: Strong recommendation, high quality of evidence). Similar to acute myocardial infarction, vascular insufficiency experienced in stroke likely warrants a more guarded approach to mobility. Additional studies exploring timing beyond 24 hours and dose of mobility interventions are warranted in discreet populations.

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A Systematic Review of Interventions to Improve Healthcare Experiences and Access in Autism

Review Journal of Autism and Developmental Disorders ◽

10.1007/s40489-021-00279-2 ◽

2021 ◽

Author(s):

Chloe Walsh ◽

Paul O’Connor ◽

Ellen Walsh ◽

Sinéad Lydon

Keyword(s):

Systematic Review ◽

Morbidity And Mortality ◽

Future Research ◽

Medical Procedures ◽

Autistic Individual ◽

Healthcare Experiences ◽

Complete Detail ◽

Or Organization ◽

What Matters ◽

Research Studies

AbstractAutistic individuals report barriers to accessing and receiving healthcare, and experience increased morbidity and mortality. This systematic review synthesizes 31 research studies evaluating interventions implemented to improve the healthcare experiences and/or access of autistic persons. Interventions were most commonly patient-focused (58.1%), focused on supporting the autistic individual to engage with, tolerate, or anticipate medical procedures, care, or settings. Fewer studies were provider-focused (48.4%) or organization-focused (6.5%). Interventions were typically evaluated using measures of reactions (45.2%) or behavior (48.4%), and outcomes were predominantly positive (80.6%). Further research is imperative and should look to how providers and organizations must change. Future research must be inclusive of the autistic community, must measure what matters, and must offer complete detail on interventions implemented.

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