scholarly journals Content and Criterion Validity of the Preliminary Core Dataset for Clinical Trials in Fibromyalgia Syndrome

2009 ◽  
Vol 36 (10) ◽  
pp. 2330-2334 ◽  
Author(s):  
ERNEST H. CHOY ◽  
LESLEY M. ARNOLD ◽  
DANIEL J. CLAUW ◽  
LESLIE J. CROFFORD ◽  
JENNIFER M. GLASS ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Outcome Measures ◽  
Outcome Measurement ◽  
Criterion Validity ◽  
Pooled Analysis ◽  
Data Set ◽  
Core Data ◽  
The Core ◽  
Related Quality ◽  
Convergent And Divergent Validity

Objective.Increasing research interest and emerging new therapies for treatment of fibromyalgia (FM) have led to a need to develop a consensus on a core set of outcome measures that should be assessed and reported in all clinical trials, to facilitate interpretation of the data and understanding of the disease. This aligns with the key objective of the Outcome Measures in Rheumatology (OMERACT) initiative to improve outcome measurement through a data driven, interactive consensus process.Methods.Through patient focus groups and Delphi processes, working groups at previous OMERACT meetings identified potential domains to be included in the core data set. A systematic review has shown that instruments measuring these domains are available and are at least moderately sensitive to change. Most instruments have been validated in multiple languages. This pooled analysis study aims to develop the core data set by analyzing data from 10 randomized controlled trials (RCT) in FM.Results.Results from this study provide support for the inclusion of the following in the core data set: pain, tenderness, fatigue, sleep, patient global assessment, and multidimensional function/health related quality of life. Construct validity was demonstrated with outcome instruments showing convergent and divergent validity. Content and criterion validity were confirmed by multivariate analysis showing R square values between 0.4 and 0.6. Low R square value is associated with studies in which one or more domains were not assessed.Conclusion.The core data set was supported by high consensus among attendees at OMERACT 9. Establishing an international standard for RCT in FM should facilitate future metaanalyses and indirect comparisons.

scholarly journals On self-neglect and safeguarding adult reviews: diminishing returns or adding value?

2017 ◽  
Vol 19 (2) ◽  
pp. 53-66 ◽  
Author(s):  
Michael Preston-Shoot
Keyword(s):  
Thematic Analysis ◽  
Annual Reports ◽  
National Database ◽  
Service Improvement ◽  
Policy And Practice ◽  
Data Set ◽  
Content Type ◽  
Core Data ◽  
The Core

Purpose The purpose of this paper is twofold: first, to update the core data set of self-neglect serious case reviews (SCRs) and safeguarding adult reviews (SARs), and accompanying thematic analysis; second, to respond to the critique in the Wood Report of SCRs commissioned by Local Safeguarding Children Boards (LSCBs) by exploring the degree to which the reviews scrutinised here can transform and improve the quality of adult safeguarding practice. Design/methodology/approach Further published reviews are added to the core data set from the websites of Safeguarding Adults Boards (SABs) and from contacts with SAB independent chairs and business managers. Thematic analysis is updated using the four domains employed previously. The findings are then further used to respond to the critique in the Wood Report of SCRs commissioned by LSCBs, with implications discussed for Safeguarding Adult Boards. Findings Thematic analysis within and recommendations from reviews have tended to focus on the micro context, namely, what takes place between individual practitioners, their teams and adults who self-neglect. This level of analysis enables an understanding of local geography. However, there are other wider systems that impact on and influence this work. If review findings and recommendations are to fully answer the question “why”, systemic analysis should appreciate the influence of national geography. Review findings and recommendations may also be used to contest the critique of reviews, namely, that they fail to engage practitioners, are insufficiently systemic and of variable quality, and generate repetitive findings from which lessons are not learned. Research limitations/implications There is still no national database of reviews commissioned by SABs so the data set reported here might be incomplete. The Care Act 2014 does not require publication of reports but only a summary of findings and recommendations in SAB annual reports. This makes learning for service improvement challenging. Reading the reviews reported here against the strands in the critique of SCRs enables conclusions to be reached about their potential to transform adult safeguarding policy and practice. Practical implications Answering the question “why” is a significant challenge for SARs. Different approaches have been recommended, some rooted in systems theory. The critique of SCRs challenges those now engaged in SARs to reflect on how transformational change can be achieved to improve the quality of adult safeguarding policy and practice. Originality/value The paper extends the thematic analysis of available reviews that focus on work with adults who self-neglect, further building on the evidence base for practice. The paper also contributes new perspectives to the process of conducting SARs by using the analysis of themes and recommendations within this data set to evaluate the critique that reviews are insufficiently systemic, fail to engage those involved in reviewed cases and in their repetitive conclusions demonstrate that lessons are not being learned.

Health-Related Quality of Life in Patients with Venous Ulceration

2001 ◽  
Vol 16 (1) ◽  
pp. 12-16 ◽  
Author(s):  
A. Howard ◽  
A. H. Davies
Keyword(s):  
Quality Of Life ◽  
Outcome Measures ◽  
Outcome Measurement ◽  
Venous Ulcer ◽  
Health Related Quality ◽  
Venous Ulceration ◽  
Complete Treatment ◽  
Related Quality ◽  
Health Related

Aim: To review the role of Health Related Quality of Life (HRQL) assessments in the management of patients with venous ulceration. Method: A search of electronic databases and reference lists delivered numerous articles containing a variety of HRQL assessments for venous ulcer treatment. Synthesis: The salient points from the literature were collaborated in order to establish which outcome measures best reflect the quality of care delivered. The treatment of chronic venous leg ulceration is often prolonged and a permanent cure is frequently unattainable. An improvement in a patient's condition needs to be demonstrated in order to determine the benefit of a surgical treatment. The assessment of HRQL is increasingly recognised as a valuable surgical outcome measurement. Conclusion: The combination of ‘standard’ clinical outcome measures, the generic SF-36 and a specific ‘venous ulcer’ HRQL questionnaire can produce a more complete treatment outcome assessment in patients with venous ulceration.

scholarly journals Composite Indices Using 3 or 4 Components of the Core Data Set Have Similar Predictive Ability to Measure Disease Activity in RA: Evidence from the DANCER and REFLEX Studies

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Martin J. Bergman ◽  
William Reiss ◽  
Carol Chung ◽  
Pamela Wong ◽  
Adam Turpcu
Keyword(s):  
Clinical Trials ◽  
Assessment Tool ◽  
Predictive Ability ◽  
Disease Assessment ◽  
Control Treatment ◽  
Routine Practice ◽  
Data Set ◽  
Study Objective ◽  
Core Data ◽  
Composite Indices

Background. Understanding how disease-assessment indices perform in rheumatoid arthritis (RA) clinical trials can inform their use in routine practice. The study objective was to assess the capacity of combinations of RA Core Data Set measures to distinguish rituximab from control treatment.Methods. Post hoc analysis of two randomised clinical trials was used. Composite Efficacy Indices were derived by combining three or four RA Core Data Set measures from three possible sources: physician, patient, and laboratory.Results. All 105 Composite Efficacy Indices evaluated significantly distinguished rituximab from control treatment (P<10−7). Generally, indices containing measures from three different sources had a greater capacity to distinguish rituximab from control treatment than indices containing three measures from one source. Composite Efficacy Indices performed as well as validated indices such as DAS28, RAPID3, and CDAI.Conclusions. All indices composed of three or four RA Core Data Set measures have a similar capacity to detect treatment differences. These results suggest that the precise measurement used is less important than whether any measurement is performed, although selection should be consistent for each patient. Therefore, the choice of assessment tool should not be limited to a prescribed list and should instead be left to the clinician’s discretion.

Clinical trial designs in anaesthesia

2017 ◽  
Author(s):  
Simon J. Howell
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Outcome Measures ◽  
Control Group ◽  
Or Groups ◽  
Related Quality ◽  
Health Related ◽  
Economic Analyses ◽  
Surrogate Measures ◽  
The Impact

A clinical trial is a research study that assigns people or groups to different interventions and compares the impact of these on health outcomes. This chapter examines the design and delivery of clinical trials in anaesthesia and perioperative medicine covering the issues outlined below. The features of a high-quality clinical trial include well-defined inclusion and exclusion criteria, a control group, randomization, and blinding. Outcome measures may be broadly divided into counting the number of people who experience an outcome and taking measurements on people. The outcome measures selected for a clinical trial reflect the purpose of the study and may include ‘true’ clinical measures such as major postoperative complications or surrogate measures such as the results of a biochemical test. Outcome measures may be combined in a composite outcome. Assessment of health-related quality of life using a tool such as the SF-36 questionnaire is an important aspect of many clinical trials in its own right and also informs the economic analyses that may be embedded in a trial. Determining the number for recruits needed for a clinical trial requires both clinical and statistical insight and judgement. The analysis of a clinical trial requires a similarly sophisticated approach that takes into account the objectives of the study and balances the need for appropriate subgroup analyses with the risk of false-positive results. The safe and effective management of a clinical trial requires rigorous organizational discipline and an understanding of the ethical and regulatory structures that govern clinical research.

scholarly journals Self-neglect and safeguarding adult reviews: towards a model of understanding facilitators and barriers to best practice

2019 ◽  
Vol 21 (4) ◽  
pp. 219-234 ◽  
Author(s):  
Michael Preston-Shoot
Keyword(s):  
Thematic Analysis ◽  
Good Practice ◽  
National Database ◽  
Evidence Based ◽  
Effective Practice ◽  
Data Set ◽  
Content Type ◽  
Core Data ◽  
The Core ◽  
Evidence Based Model

Purpose The purpose of this paper is twofold: first, to update the core data set of self-neglect safeguarding adult reviews (SARs) and accompanying thematic analysis; second, to draw together the learning available from this data set of reviews to propose a model of good practice that can be used as the basis for subsequent SARs. Design/methodology/approach Further published reviews are added to the core data set from the websites of Safeguarding Adults Boards (SABs). Thematic analysis is updated using the four domains employed previously. A sufficient number of reviews have been performed from which to construct an evidence-based model of good practice. A framework is presented with the proposition that this can be used as a proportional methodology for further SARs where self-neglect is in focus. Findings Familiar findings emerge from the thematic analysis. This level of analysis, constructed over time and across reviews, enables a framework to be developed that pulls together the findings into a model of good practice with individuals who self-neglect and for policies and procedures with which to support those practitioners involved in such cases. This framework can then be used as an evidence-based model with which to review new cases where SARs are commissioned. Research limitations/implications The national database of reviews commissioned by SABs is incomplete and does not contain many of the SARs reported in this evolving data set. The Care Act 2014 does not require publication of reports but only a summary of findings and recommendations in SAB annual reports. It is possible, therefore, that this data set is also incomplete. Drawing together the findings from the reviews nonetheless enables conclusions to be proposed about the components of effective practice, and effective policy and organisational arrangements for practice. Future reviews can then explore what enables such effective to be achieved and what barriers obstruct the realisation of effective practice. Practical implications Answering the question “why” is a significant challenge for SARs. A framework is presented here, drawn from research on SARs featuring self-neglect, that enables those involved in reviews to explore the enablers and barriers with respect to an evidence-based model of effective practice. The framework introduces explicitly research and review evidence into the review process. Originality/value The paper extends the thematic analysis of available reviews that focus on work with adults who self-neglect, further building on the evidence base for practice. The paper also proposes a new approach to SARs by using the findings and recommendations systematically within a framework designed to answer “why” questions – what promotes and what obstructs effective practice.

On (not) learning from self-neglect safeguarding adult reviews

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Michael Preston-Shoot
Keyword(s):  
Thematic Analysis ◽  
Good Practice ◽  
Evidence Base ◽  
National Database ◽  
Effective Practice ◽  
Data Set ◽  
Content Type ◽  
Core Data ◽  
The Core ◽  
National Analysis

Purpose The purpose of this paper is to update the core data set of self-neglect safeguarding adult reviews (SARs) and accompanying thematic analysis. It also explores whether lessons are being learned from the findings and recommendations of an increasing number of reviews on self-neglect cases. Design/methodology/approach Further published reviews are added to the core data set, mainly drawn from the websites of safeguarding adults boards (SABs). Thematic analysis is updated using the domains used previously. The domains and the thematic analysis are grounded in the evidence-based model of good practice, reported in this journal previously. Findings Familiar findings emerge from the thematic analysis and reinforce the evidence-base of good practice with individuals who self-neglect and for policies and procedures with which to support those practitioners working with such cases. Multiple exclusion homelessness and alcohol misuse are prominent. Some SABs are having to return to further cases of self-neglect to review, inviting scrutiny of what is (not) being learned from earlier findings and recommendations. Research limitations/implications The national database of reviews commissioned by SABs remains incomplete. The Care Act 2014 does not require publication of reports but only a summary of findings and recommendations in SAB annual reports. National Health Service Digital annual data sets do not enable the identification of reviews by types of abuse and neglect. However, the first national analysis of SARs has found self-neglect to be the most prominent type of abuse and/or neglect reviewed. Drawing together the findings builds on what is known about the components of effective practice, and effective policy and organisational arrangements for practice. Practical implications Answering the question “why” remains a significant challenge for SARs. The findings confirm the relevance of the evidence-base for effective practice but SARs are limited in their analysis of what enables and what obstructs the components of best practice. Greater explicit use of research and other published SARs might assist with answering the “why” question. Greater scrutiny is needed of the impact of the national legal, policy and financial context within which adult safeguarding is situated. Originality/value The paper extends the thematic analysis of available reviews that focus on study with adults who self-neglect, further reinforcing the evidence base for practice. Propositions are explored, concerned with whether learning is being maximised from the process of case review.

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