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

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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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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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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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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