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

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).

scholarly journals Development of a Core Outcome Set for Clinical Trials of Traditional Chinese Medicine in Lung Cancer: a Study Protocol

2021 ◽  
Author(s):  
Mingyan Zhang ◽  
Hui Zi Chua ◽  
Bohan Niu ◽  
Kai Li ◽  
Junhua Zhang
Keyword(s):  
Lung Cancer ◽  
Decision Making ◽  
Clinical Trials ◽  
Methodological Quality ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Stakeholder Groups ◽  
The Core ◽  
Outcome Set

Abstract Background: Lung cancer (LC) is currently the leading cause of cancer death globally. LC accounts for a high mortality and incidence rate of cancer in both men and women. Radiotherapy and chemotherapy, though effective for some patients, have strong side effects and most of them only have palliative effect. Though many studies reported the effectiveness of traditional Chinese medicine (TCM) treatment on LC, the lack of methodological quality in clinical trials resulted in heterogeneous reporting of outcomes, making it difficult to compare and combine in different trials, limiting the validity of meta-analysis and reducing the value of clinical studies. A core outcome set (COS) could reduce outcome reporting bias and heterogeneity across studies of LC using TCM-related interventions. The aim of this study is to develop a standardized COS for LC in TCM clinical trials (COS-TCM-LC) to improve the methodological quality of TCM clinical studies to serve as a guidance in healthcare decision making for LC.Methods: The study has been developed according to the Core Outcome Set-STAandards for Development standards for the design of a COS study. The study process consisted 4 stages as follows: (1) Identifying a list of potential outcomes through systematic reviews of TCM RCTs and 2 clinical registry databases, qualitative surveys on patients and healthcare professionals to form an outcome pool and finally establishing a preliminary checklist of outcomes. (2) Selection of stakeholder groups. (3) Representatives of stakeholder groups will be invited to participate in a two-round Delphi survey. (4) A face-to-face consensus meeting will be held to determine the final COS-TCM-LC.Discussion: In this study protocol, we have followed the guidelines of COS-STAndardized Protocol (STAP) statement and checked the items in COS-STAndards for Developement (STAD). Developing a COS-TCM-LC will improve the quality of future RCTs on LC with the TCM interventions and promote better evidence-based clinical decision-making.Trial registration: This study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1483 (http://www.comet-initiative.org/studies/details/1483).

scholarly journals Outcomes and outcomes measurements used in intervention studies of pelvic girdle pain and lumbopelvic pain: a systematic review

2019 ◽  
Vol 27 (1) ◽  
Author(s):  
Francesca Wuytack ◽  
Maggie O’Donovan
Keyword(s):  
Systematic Review ◽  
Intervention Studies ◽  
Core Outcome Set ◽  
Pelvic Girdle ◽  
Pelvic Girdle Pain ◽  
Cochrane Library ◽  
Core Outcome ◽  
Outcome Set ◽  
Pregnancy And Postpartum

Abstract Background Pelvic girdle pain is a common problem during pregnancy and postpartum with significant personal and societal impact and costs. Studies examining the effectiveness of interventions for pelvic girdle pain measure different outcomes, making it difficult to pool data in meta-analysis in a meaningful and interpretable way to increase the certainty of effect measures. A consensus-based core outcome set for pelvic girdle pain can address this issue. As a first step in developing a core outcome set, it is essential to systematically examine the outcomes measured in existing studies. Objective The objective of this systematic review was to identify, examine and compare what outcomes are measured and reported, and how outcomes are measured, in intervention studies and systematic reviews of interventions for pelvic girdle pain and for lumbopelvic pain (which includes pelvic girdle pain). Methods We searched PubMed, Cochrane Library, PEDro and Embase from inception to the 11th May 2018. Two reviewers independently selected studies by title/abstract and by full text screening. Disagreement was resolved through discussion. Outcomes reported and their outcome measurement instruments were extracted and recorded by two reviewers independently. We assessed the quality of reporting with two independent reviewers. The outcomes were grouped into core domains using the OMERACT filter 2.0 framework. Results A total of 107 studies were included, including 33 studies on pelvic girdle pain and 74 studies on lumbopelvic pain. Forty-six outcomes were reported across all studies, with the highest amount (26/46) in the ‘life impact’ domain. ‘Pain’ was the most commonly reported outcome in both pelvic girdle pain and lumbopelvic pain studies. Studies used different instruments to measure the same outcomes, particularly for the outcomes pain, function, disability and quality of life. Conclusions A wide variety of outcomes and outcome measurements are used in studies on pelvic girdle pain and lumbopelvic pain. The findings of this review will be included in a Delphi survey to reach consensus on a pelvic girdle pain - core outcome set. This core outcome set will allow for more effective comparison between future studies on pelvic girdle pain, allowing for more effective translation of findings to clinical practice.

scholarly journals Development of a Core Set of Patient-Reported Outcomes for Population-Based Cancer Survivorship Research: Protocol for an Australian Consensus Study

10.2196/14544 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e14544 ◽  
Author(s):  
Imogen Ramsey ◽  
Nadia Corsini ◽  
Amanda D Hutchinson ◽  
Julie Marker ◽  
Marion Eckert
Keyword(s):  
Cancer Survivors ◽  
Cancer Survivorship ◽  
Phase Ii ◽  
Core Outcome Set ◽  
Population Based ◽  
Core Outcome ◽  
The Core ◽  
Outcome Set ◽  
Core Set

Background Core outcome sets seek to improve the consistency and quality of research by providing agreed-upon recommendations regarding what outcomes should be measured as a minimum for a population and setting. The problems arising from a lack of outcome standardization in population-based cancer survivorship research indicate the need for agreement on a core set of patient-reported outcomes (PROs) to enhance data quality, consistency, and comparability. Objective This study aims to identify a core set of PROs, representing the most important issues impacting on cancer survivors' long-term health, functioning and quality of life, to inform population-based research on cancer survivorship. Methods In Phase I, a list of all potentially important outcomes will be generated through focus group discussions with cancer survivors and a review of measures for assessing quality of life in cancer survivorship. The consolidated list will be advanced to Phase II, where a stakeholder consensus process will be conducted with national experts in cancer survivorship to refine and prioritize the outcomes into a core outcome set. The process will consist of a two-round Delphi survey and a consensus meeting. Cancer survivors, oncology health care professionals, and potential end users of the core outcome set with expertise in cancer survivorship research or policy will be invited to participate. In Phase III, recommended measures for assessment of the core outcome set will be selected with advice from experts on the assessment, analysis, and interpretation of PROs. Results As of April 2019, data collection for Phase I is complete and data analysis is underway. These data will inform the list of outcomes to be advanced into Phase II. Recruitment for Phase II will commence in June 2019, and it is anticipated that it will take 6 months to complete the three-step consensus process and identify a provisional core outcome set. The study results are expected to be published in early 2020. Conclusions Expert consensus-driven recommendations on outcome measurement will facilitate the inclusion of survivorship outcomes considered important by cancer survivors and health professionals in future research. Adoption of the core outcome set will enable comparison and synthesis of evidence across studies and enhance the quality of PRO data collected in cancer survivorship research, particularly when applied to address macro-level questions. International Registered Report Identifier (IRRID) DERR1-10.2196/14544

scholarly journals Developing a core outcome set for interventions to improve discharge from mental health inpatient services: a survey, Delphi and consensus meeting with key stakeholder groups

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e034215
Author(s):  
Natasha Tyler ◽  
Nicola Wright ◽  
Andrew Grundy ◽  
Justin Waring
Keyword(s):  
Mental Health ◽  
Health Services ◽  
Healthcare Professionals ◽  
Core Outcome Set ◽  
Consensus Meeting ◽  
Service Users ◽  
Core Outcome ◽  
Stakeholder Groups ◽  
The Core ◽  
Outcome Set

ObjectiveTo develop a core set of outcomes to be used in all future studies into discharge from acute mental health services to increase homogeneity of outcome reporting.DesignWe used a cross-sectional online survey with qualitative responses to derive a comprehensive list of outcomes, followed by two online Delphi rounds and a face-to-face consensus meeting.SettingThe setting the core outcome set applies to is acute adult mental health.ParticipantsParticipants were recruited from five stakeholder groups: service users, families and carers, researchers, healthcare professionals and policymakers.InterventionsThe core outcome set is intended for all interventions that aim to improve discharge from acute mental health services to the community.ResultsNinety-three participants in total completed the questionnaire, 69 in Delphi round 1 and 68 in round 2, with relatively even representation of groups. Eleven participants attended the consensus meeting. Service users, healthcare professionals, researchers, carers/families and end-users of research agreed on a four-item core outcome set: readmission, suicide completed, service user-reported psychological distress and quality of life.ConclusionImplementation of the core outcome set in future trials research will provide a framework to achieve standardisation, facilitate selection of outcome measures, allow between-study comparisons and ultimately enhance the relevance of trial or research findings to healthcare professionals, researchers, policymakers and service users.

scholarly journals Development of a core outcome set for the evaluation of interventions to enhance trial participation decisions on behalf of adults who lack capacity to consent: a mixed methods study (COnSiDER Study)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
V. Shepherd ◽  
F. Wood ◽  
M. Robling ◽  
E. Randell ◽  
K. Hood
Keyword(s):  
Decision Making ◽  
Outcome Measures ◽  
Scoping Review ◽  
Core Outcome Set ◽  
Consensus Meeting ◽  
Delphi Survey ◽  
Additional Patient ◽  
Trial Participation ◽  
Core Outcome ◽  
Outcome Set

Abstract Background Trials involving adults who lack capacity to provide consent rely on proxy or surrogate decision-makers, usually a family member, to make decisions about participation. Interventions to enhance proxy decisions about trial participation are now being developed. However, a lack of standardised outcome measures limits evaluation of these interventions. The aim of this study was to establish an agreed standardised core outcome set (COS) for use when evaluating interventions to improve proxy decisions about trial participation. Methods We used established methods to develop the COS including a consensus study with key stakeholder groups comprising those who will use the COS in research (researchers and healthcare professionals) and patients or their representatives. Following a scoping review to identify candidate items, we used a modified two-round Delphi survey to achieve consensus on core outcomes, with equivocal items taken to a consensus meeting for discussion. The COS was finalised following an online consensus meeting in October 2020. Results A total of 28 UK stakeholders (5 researchers, 10 trialists, 3 patient/family representatives, 7 recruiters and 3 advisors/approvers) participated in the online Delphi survey to rank candidate items from the scoping review (n = 36) and additional items proposed by participants (n = 1). Items were broadly grouped into three categories: how family members make decisions, their experiences of making decisions, and the personal aspects that influence the decision. Following the Delphi survey, 27 items were included and ten items exhibited no consensus which required discussion at the consensus meeting. Sixteen participants attended the meeting, including additional patient/family representatives invited to increase representation from this key group (n = 2). We reached consensus for the inclusion of 28 outcome items, including one selected at the consensus meeting. Conclusions The study identified outcomes that should be measured as a minimum in all evaluations of interventions to enhance proxy decisions about trials. These relate to the process of decision-making, proxies’ experience of decision-making, and factors that influence decision-making such as understanding. Further work with people with impairing conditions and their families is needed to explore their views about the COS and to identify appropriate outcome measures and timing of measurement. Trial registration The study is registered on the COMET database (https://www.comet-initiative.org/Studies/Details/1409)

scholarly journals A Systematic Review of Outcome Reporting, Definition and Measurement Heterogeneity in Non-Muscle Invasive Bladder Cancer Effectiveness Trials of Adjuvant, Prophylactic Treatment After Transurethral Resection

2021 ◽  
pp. 1-21
Author(s):  
Erik Veskimae ◽  
Selvarani Subbarayan ◽  
Riccardo Campi ◽  
Domitille Carron ◽  
Muhammad Imran Omar ◽  
...  
Keyword(s):  
Core Outcome Set ◽  
Evidence Based ◽  
Core Outcome ◽  
Muscle Invasive Bladder Cancer ◽  
Evidence Based Treatment ◽  
Outcome Reporting ◽  
Outcome Set ◽  
Effectiveness Trials ◽  
Muscle Invasive ◽  
Meta Analyses

Abstract: BACKGROUND: Heterogenous outcome reporting in non-muscle-invasive bladder cancer (NMIBC) effectiveness trials of adjuvant intervention after transurethral resection (TURBT) has been noted in systematic reviews (SRs). This hinders comparing results across trials, combining them in meta-analyses, and evidence-based decision-making for patients and clinicians. OBJECTIVE: We aimed to systematically review the extent of reporting and definition heterogeneity. METHODS: We included randomized controlled trials (RCTs) identified from SRs comparing adjuvant treatments after TURBT or TURBT alone in patients with NMIBC (with or without carcinoma in situ) published between 2000–2020. Abstracts and full texts were screened independently by two reviewers. Data were extracted by one reviewer and checked by another. RESULTS: We screened 807 abstracts; from 15 SRs, 57 RCTs were included. Verbatim outcome names were coded to standard outcome names and organised using the Williamson and Clarke taxonomy. Recurrence (98%), progression (74%), treatment response (in CIS studies) (40%), and adverse events (77%) were frequently reported across studies. However, overall (33%) and cancer-specific (33%) survival, treatment completion (17%) and treatment change (37%) were less often reported. Quality of Life (3%) and economic outcomes (2%) were rarely reported. Heterogeneity was evident throughout, particularly in the definitions of progression and recurrence, and how CIS patients were handled in the analysis of studies with predominantly papillary patients, highlighting further issues with the definition of recurrence and progression vs treatment response for CIS patients. Data reporting was also inconsistent, with some trials reporting event rates at various time-points and others reporting time-to-event with or without Hazard Ratios. Adverse events were inconsistently reported. QoL data was absent in most trials. CONCLUSIONS: Heterogenous outcome reporting is evident in NMIBC effectiveness trials. This has profound implications for meta-analyses, SRs and evidence-based treatment decisions. A core outcome set is required to reduce heterogeneity. PATIENT SUMMARY: This systematic review found inconsistencies in outcome definitions and reporting, pointing out the urgent need for a core outcome set to help improve evidence-based treatment decisions. Keywords:

scholarly journals Development of a core outcome set for traumatic brachial plexus injuries (COMBINE): study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e030146 ◽  
Author(s):  
Caroline Miller ◽  
Jane Cross ◽  
Dominic M Power ◽  
Derek Kyte ◽  
Christina Jerosch-Herold
Keyword(s):  
Systematic Review ◽  
Brachial Plexus ◽  
Clinical Outcomes ◽  
Clinical Care ◽  
Core Outcome Set ◽  
Evidence Based ◽  
Core Outcome ◽  
Permanent Disability ◽  
Outcome Set ◽  
Patient Reported

IntroductionTraumatic brachial plexus injury (TBPI) involves major trauma to the large nerves of the arm which control the movement and sensation. Fifty per cent of injuries result in complete paralysis of the arm with many other individuals having little movement, sensation loss and unremitting pain. The injury often causes severe and permanent disability affecting work and social life, with an estimated cost to the National Health Service and the economy of £35 million per annum. Advances in microsurgery have resulted in an increase in interventions aimed at reconstructing these injuries. However, data to guide evidence-based decisions is lacking. Different outcomes are used across studies to assess the effectiveness of treatments. This has impeded our ability to synthesise results to determine which treatments work best. Studies frequently report short-term clinical outcomes but rarely report longer term outcomes and those focused on quality of life. This project aims to produce a core outcome set (COS) for surgical and conservative management of TBPI. The TBPI COS will contain a minimum set of outcomes to be reported and measured in effectiveness studies and collected through routine clinical care.Methods and analysisThis mixed-methods project will be conducted in two phases. In phase 1 a long list of patient-reported and clinical outcomes will be identified through a systematic review. Interviews will then explore outcomes important to patients. In phase 2, the outcomes identified across the systematic review, and the interviews will be included in a three-round online Delphi exercise aiming to reach consensus on the COS. The Delphi process will include patient and healthcare participants. A consensus meeting will be held to achieve the final COS.Ethics and disseminationThe use of a COS in TBPI will increase the relevance of research and clinical care to all stakeholders, facilitate evidence synthesis and evidence-based decision making. The study has ethical approval.Trial registration numbersCRD42018109843.

scholarly journals Core outcome set for preventive intervention trials in chronic and episodic migraine (COSMIG): an international, consensus-derived and multistakeholder initiative

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e043242
Author(s):  
Kirstie Haywood ◽  
Rachel Potter ◽  
Robert Froud ◽  
Gemma Pearce ◽  
Barbara Box ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Healthcare Professionals ◽  
Core Outcome Set ◽  
Episodic Migraine ◽  
Consensus Meeting ◽  
Good Representation ◽  
Core Outcome ◽  
The Core ◽  
Outcome Set

ObjectiveTypically, migraine prevention trials focus on reducing migraine days. This narrow focus may not capture all that is important to people with migraine. Inconsistency in outcome selection across trials limits the potential for data pooling and evidence synthesis. In response, we describe the development of core outcome set for migraine (COSMIG).DesignA two-stage approach sought to achieve international, multistakeholder consensus on both the core domain set and core measurement set. Following construction of a comprehensive list of outcomes, expert panellists (patients, healthcare professionals and researchers) completed a three-round electronic-Delphi study to support a reduction and prioritisation of core domains and outcomes. Participants in a consensus meeting finalised the core domains and methods of assessment. All stages were overseen by an international core team, including patient research partners.ResultsThere was a good representation of patients (episodic migraine (n=34) and chronic migraine (n=42)) and healthcare professionals (n=33) with high response and retention rates. The initial list of domains and outcomes was reduced from >50 to 7 core domains for consideration in the consensus meeting, during which a 2-domain core outcome set was agreed.ConclusionInternational and multistakeholder consensus emerged to describe a two-domain core outcome set for reporting research on preventive interventions for chronic and episodic migraine: migraine-specific pain and migraine-specific quality of life. Intensity of migraine pain assessed with an 11-point Numerical Rating Scale and the frequency as the number of headache/migraine days over a specified time period. Migraine-specific quality of life assessed using the Migraine Functional Impact Questionnaire.

scholarly journals Outcomes reported in clinical studies of stable angina pectoris on traditional Chinese medicine: a systematic review towards a core outcome set

2021 ◽  
Author(s):  
Mingyan Zhang ◽  
Hui Zi Chua ◽  
Bohan Niu ◽  
Wenke Zheng ◽  
Fengwen Yang ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Clinical Studies ◽  
Clinical Symptoms ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Outcome Reporting ◽  
Outcome Set ◽  
Symptoms And Signs

Abstract Background Traditional Chinese medicine (TCM) plays an important role in contributing to the public health in China. However, non-standardized outcomes in TCM related studies posed great difficulty in data synthesis for healthcare decisions. An agreed set of standardized outcomes, or termed as a core outcome set (COS), can solve this existing problem of outcome heterogeneity. This review aimed to analyze outcome heterogeneity, assess the quality of outcome reporting and providing a list of potential outcomes for COS development of SAP using TCM. Methods 8 literature databases were searched to identify clinical studies about TCM for SAP (SAP-TCM) of yearly samples of 2005, 2010, 2015, 2016, 2018 and 2019. 2 clinical registry databases were searched from inception to October 2020. Outcomes definition, measurement methods and time-point were extracted and categorized into 7 themes which include clinical symptoms and signs, physical and chemical examination, TCM-related outcomes, adverse events, quality of life, long-term prognosis and economic evaluation. Timing and quality assessment of the outcomes reported were analyzed and evaluated. Results A total of 1166 studies were included from 12962 potential studies, involving 111426 patients. 231 outcomes were identified and a total of 89 outcomes reported at least twice in the studies. The most commonly reported theme was clinical symptoms and signs. The most frequently reported outcomes were total rate of ECG efficiency and angina attack in clinical studies of published literature and clinical registries databases respectively. Outcomes reported in a single study ranged from 1 to 15, and 5 outcomes on average per study. 80% of the studies lack reporting of primary outcomes. A wide variation of measurement instruments or methods was used. A range of 1–17 measurement time-points were recorded. Quality assessment of outcome reporting was generally low, with 65.6% of the studies scoring 3 to 4 points. Conclusion Outcomes reported in studies on SAP-TCM are heterogeneous. A lack of standardization complicates comparisons of outcomes across studies. Developing a COS for SAP-TCM could contribute to the standardization of outcome reporting and offer a stronger evidence for health decision-making.

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