scholarly journals Clinical Trials and Outcome Measures in Adults With Hearing Loss

2021 ◽  
Vol 12 ◽  
Author(s):  
Kevin J. Munro ◽  
William M. Whitmer ◽  
Antje Heinrich
Keyword(s):  
Clinical Trials ◽  
Hearing Loss ◽  
Outcome Measures ◽  
Health Professionals ◽  
Research Question ◽  
Measurement Instrument ◽  
Target Population ◽  
Evidence Base ◽  
Health Condition ◽  
Hearing Health

Clinical trials are designed to evaluate interventions that prevent, diagnose or treat a health condition and provide the evidence base for improving practice in health care. Many health professionals, including those working within or allied to hearing health, are expected to conduct or contribute to clinical trials. Recent systematic reviews of clinical trials reveal a dearth of high quality evidence in almost all areas of hearing health practice. By providing an overview of important steps and considerations concerning the design, analysis and conduct of trials, this article aims to give guidance to hearing health professionals about the key elements that define the quality of a trial. The article starts out by situating clinical trials within the greater scope of clinical evidence, then discusses the elements of a PICO-style research question. Subsequently, various methodological considerations are discussed including design, randomization, blinding, and outcome measures. Because the literature on outcome measures within hearing health is as confusing as it is voluminous, particular focus is given to discussing how hearing-related outcome measures affect clinical trials. This focus encompasses how the choice of measurement instrument(s) affects interpretation, how the accuracy of a measure can be estimated, how this affects the interpretation of results, and if differences are statistically, perceptually and/or clinically meaningful to the target population, people with hearing loss.

scholarly journals How to design and set up a clinical trial part 1: the research question

2019 ◽  
Vol 12 (3) ◽  
pp. 111-116
Author(s):  
Amarpreet Atwal ◽  
Philip E Benson
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Relevance ◽  
Clinical Care ◽  
Research Question ◽  
Relevant Information ◽  
Evidence Base ◽  
Human Participants ◽  
Set Up

Data from clinical trials involving human participants are essential in establishing an evidence base about the safety and effectiveness of our treatments. This first article describes the steps involved in designing and setting up a clinical trial, from establishing the research question(s) to searching the literature. Acquiring some knowledge about how to set up a clinical trial will allow the conscientious clinician to use the most relevant information to provide the highest possible standards of clinical care for his/her patients. CPD/Clinical Relevance: Even if a clinician is not, has never been, nor is ever planning to be involved in research, he/she should understand and be able to interpret the data from clinical trials.

scholarly journals The OMERACT-OARSI Core Domain Set for Measurement in Clinical Trials of Hip and/or Knee Osteoarthritis

2019 ◽  
Vol 46 (8) ◽  
pp. 981-989 ◽  
Author(s):  
Toby O. Smith ◽  
Gillian A. Hawker ◽  
David J. Hunter ◽  
Lyn M. March ◽  
Maarten Boers ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Knee Osteoarthritis ◽  
Health Professionals ◽  
Outcome Measurement ◽  
Measurement Instrument ◽  
Research Society ◽  
Delphi Survey ◽  
Core Domain ◽  
Knee Oa ◽  
Core Domain Set

Objective.To update the 1997 OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) core domain set for clinical trials in hip and/or knee osteoarthritis (OA).Methods.An initial review of the COMET database of core outcome sets (COS) was undertaken to identify all domains reported in previous COS including individuals with hip and/or knee OA. These were presented during 5 patient and health professionals/researcher meetings in 3 continents (Europe, Australasia, North America). A 3-round international Delphi survey was then undertaken among patients, healthcare professionals, researchers, and industry representatives to gain consensus on key domains to be included in a core domain set for hip and/or knee OA. Findings were presented and discussed in small groups at OMERACT 2018, where consensus was obtained in the final plenary.Results.Four previous COS were identified. Using these, and the patient and health professionals/researcher meetings, 50 potential domains formed the Delphi survey. There were 426 individuals from 25 different countries who contributed to the Delphi exercise. OMERACT 2018 delegates (n = 129) voted on candidate domains. Six domains gained agreement as mandatory to be measured and reported in all hip and/or knee OA clinical trials: pain, physical function, quality of life, and patient’s global assessment of the target joint, in addition to the mandated core domain of adverse events including mortality. Joint structure was agreed as mandatory in specific circumstances, i.e., depending on the intervention.Conclusion.The updated core domain set for hip and/or knee OA has been agreed upon. Work will commence to determine which outcome measurement instrument should be recommended to cover each core domain.

EULAR points to consider for conducting clinical trials in systemic lupus erythematosus: literature based evidence for the selection of endpoints: Table 1

2008 ◽  
Vol 68 (4) ◽  
pp. 477-483 ◽  
Author(s):  
G K Bertsias ◽  
J P A Ioannidis ◽  
J Boletis ◽  
S Bombardieri ◽  
R Cervera ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Clinical Trials ◽  
Literature Review ◽  
Outcome Measures ◽  
Lupus Erythematosus ◽  
Task Force ◽  
Evidence Base ◽  
Cochrane Library ◽  
Systemic Lupus ◽  
End Points

Objective:To assess available evidence on the use of end-points (outcome measures) in clinical trials in systemic lupus erythematosus (SLE), as a part of the development of evidence-based recommendations for points to consider in clinical trials in SLE.Methods:The European League Against Rheumatism (EULAR) Task Force on SLE comprised 19 specialists, a clinical epidemiologist and a research fellow. Key questions addressing the evidence for clinical trial end-points in SLE were compiled using the Delphi technique. A systematic search of the PubMed and Cochrane Library databases was performed using McMaster/Hedges clinical query strategies and an array of relevant terms. Evidence was categorised based on sample size and type of design, and the categories of available evidence were identified for each recommendation. The strength of recommendation was assessed based on the category of available evidence and agreement on the statements was measured across the 19 specialists.Results:Eight questions were generated regarding end-points for clinical trials. The evidence to support each proposition was evaluated. The literature review revealed that most outcome measures used in phase 2/3 trials in SLE have not been formally validated in clinical trials, although some indirect validation has been undertaken.Conclusion:This systematic literature review forms the evidence base considered in the development of the EULAR recommendations for end-points in clinical trials in SLE.

How to Choose Core Outcome Measurement Sets for Clinical Trials: OMERACT 11 Approves Filter 2.0

2014 ◽  
Vol 41 (5) ◽  
pp. 1025-1030 ◽  
Author(s):  
Maarten Boers ◽  
John R. Kirwan ◽  
Laure Gossec ◽  
Philip G. Conaghan ◽  
Maria-Antonietta D’Agostino ◽  
...  
Keyword(s):  
Conceptual Framework ◽  
Outcome Measures ◽  
Outcome Measurement ◽  
Measurement Instrument ◽  
Health Condition ◽  
Core Outcome ◽  
Core Domain ◽  
Face To Face ◽  
Life Impact ◽  
Core Sets

Objective.The Outcome Measures in Rheumatology (OMERACT) initiative works to develop core sets of outcome measures for trials and observational studies in rheumatology. At the OMERACT 11 meeting, substantial time was devoted to discussing a conceptual framework and a proposal for a more explicit working process to develop what we now propose to term core outcome measurement sets, collectively termed “OMERACT Filter 2.0.”Methods.Preconference work included a literature review, and discussion of preliminary proposals through face-to-face discussions and Internet-based surveys with people within and outside rheumatology. At the conference, 5 interactive sessions comprising plenary and small-group discussions reflected on the proposals from the viewpoint of previous and ongoing OMERACT work. These considerations were brought together in a final OMERACT presentation seeking consensus agreement for the Filter 2.0 framework.Results.After debate, clarification, and agreed alterations, the final proposal suggested all core sets should contain at least 1 measurement instrument from 3 Core Areas: Death, Life Impact, and Pathophysiological Manifestations, and preferably 1 from the area Resource Use. The process of core set development for a health condition starts by selecting core domains within the areas (“core domain set”). This requires literature searches, involvement (especially of patients), and at least 1 consensus process. Next, developers select at least 1 applicable measurement instrument for each core domain. Applicability refers to the original OMERACT Filter and means that the instrument must be truthful (face, content, and construct validity), discriminative (between situations of interest) and feasible (understandable and with acceptable time and monetary costs). Depending on the quality of the instruments, participants formulate either a preliminary or a final “core outcome measurement set.” At final vote, 96% of participants agreed “The proposed overall framework for Filter 2.0 is a suitable basis on which to elaborate a Filter 2.0 Handbook.”Conclusion.Within OMERACT, Filter 2.0 has made established working processes more explicit and includes a broadly endorsed conceptual framework for core outcome measurement set development.

scholarly journals 48 Do Exercise Programmes for Older People with Sarcopenia or Frailty Deliver An Evidence-Based Service? Findings From A UK Survey

2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i12-i42
Author(s):  
M Chawner ◽  
S De Biase ◽  
N J Offord ◽  
O Todd ◽  
A Clegg ◽  
...  
Keyword(s):  
Resistance Training ◽  
Older People ◽  
Outcome Measures ◽  
Online Survey ◽  
Balance Training ◽  
Target Population ◽  
Exercise Programme ◽  
Median Number ◽  
Evidence Base ◽  
Exercise Programmes

Abstract Background Awareness of sarcopenia and frailty is growing and both are known to be potentially reversible with effective resistance training. We aimed to establish whether existing exercise programmes offered to people with sarcopenia or frailty adhere to the known evidence base. Methods We conducted a national on-line survey of practitioners delivering exercise programmes to older people with sarcopenia or frailty. The link to the online survey was distributed through the British Geriatrics Society, Chartered Society of Physiotherapy Special Interest Group for Older People (AGILE), the NHS England Future Collaboration Platform “Supporting People Living with Frailty” forum and social media. Questions covered target population and aims of the exercise programme, type, duration and frequency of exercise, progress assessment and outcome measures. Descriptive analyses were conducted using SPSS v24. Results 136 responses were received from respondents who worked for NHS Trusts, clinical commissioning groups, private practices, and third sector providers. 94% of respondents reported prescribing or delivering exercise programmes to people with sarcopenia or frailty. Most programmes (81/135 [60%]) were primarily designed to prevent or reduce falls. Resistance training was reported as the main focus of the programme in only 11/123 (9%); balance training was the main focus in 61/123 (50%) and functional exercise in 28/123 (23%). Exercise was offered once a week or less by 81/124 (65%) of respondents; the median number of sessions offered was 8.5 (IQR 6 to 12). Outcome measures suitable for assessing the effect of resistance training programmes were reported by fewer than half of respondents (hand grip: 13/119 [11%]; chair stands: 55/119 [46%], short physical performance battery: 4/119 [3%]). Conclusions Current exercise programmes offered to older people with sarcopenia or frailty lack the frequency, duration or specificity of exercise likely to improve outcomes for this group of patients.

scholarly journals Public awareness of audiology, hearing and hearing health in the Limpopo Province, South Africa

2017 ◽  
Vol 64 (1) ◽  
Author(s):  
Karin Joubert ◽  
Ben Sebothoma ◽  
Khomotjo S. Kgare
Keyword(s):  
South Africa ◽  
Hearing Loss ◽  
South African ◽  
Low Income ◽  
Health Professionals ◽  
Public Awareness ◽  
Limpopo Province ◽  
Low Income Countries ◽  
The South ◽  
Hearing Health

Background: The burden of hearing loss is on the increase, especially in low-income countries such as South Africa. The need for urgent action to prevent ear and hearing problems is a priority, especially as in many cases permanent hearing loss is preventable. In South Africa, as in other developing countries, there is a limited number of hearing health professionals and audiological resources. The lack of hearing health services may impact the general public’s awareness of hearing and hearing health. Limited information is available on the South African public’s knowledge of audiologists and the services they provide, especially in underserved rural communities.Aim: The aim of this study was to describe individuals’ awareness of the audiology profession, hearing and hearing loss, and hearing health in a rural area of the Limpopo Province.Method: A cross-sectional survey design was employed for the purpose of this study. Using a random sampling strategy, 297 households in four rural villages were selected and a selfdeveloped questionnaire was administered to one individual (18 years and older) per household. The questionnaire consisted of 23 questions targeting awareness of the audiology profession, as well as knowledge of hearing, hearing loss and hearing health.Results: Only 14% of participants were aware of the audiology profession, indicating that individuals living in rural communities are not aware of the role of audiologists and the services they provide. Doctors and nurses were identified by participants as the individuals who assist them with hearing-related problems. Although most participants (87%) acknowledged that it is very important to undergo a hearing test, only 5% have previously visited an audiologist. Most participants were aware that ear infections and excessive noise exposure can cause hearing loss. The majority also believed that ears must be kept clean at all times and used cotton buds to maintain ear hygiene.Conclusion: There is a general lack of public awareness of audiologists and the services they offer. This study highlighted the need for the National Department of Health in collaboration with professional associations and hearing health professionals to develop and implement effective strategies to increase the South African public’s awareness of the profession and the services they provide. South African universities can also play a significant role in teaching students to develop context-relevant strategies to increase awareness of the profession.

scholarly journals The OMERACT Core Set of Outcome Measures for Use in Clinical Trials of ANCA-associated Vasculitis

2011 ◽  
Vol 38 (7) ◽  
pp. 1480-1486 ◽  
Author(s):  
PETER A. MERKEL ◽  
SIBEL Z. AYDIN ◽  
MAARTEN BOERS ◽  
HANER DIRESKENELI ◽  
KAREN HERLYN ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Outcome Measures ◽  
Outcome Measurement ◽  
Measurement Instrument ◽  
The United States ◽  
Anca Associated Vasculitis ◽  
Core Set ◽  
Patient Reported ◽  
Development Evaluation ◽  
Multicenter Clinical Trials

There has been a marked increase in the past 15 years in the number and quality of clinical trials in the idiopathic inflammatory vasculitides, especially the small-vessel vasculitides known as antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis [AAV; granulomatosis, with polyangiitis (Wegener’s)]. These trials have been conducted by multicenter, international groups in Europe and the United States with financial support provided by government agencies and biopharmaceutical companies. This increased clinical trial activity in vasculitis has been accompanied by the development and validation of new outcome measures — a challenging process for these complex, multiorgan system diseases. The international OMERACT Vasculitis Working Group has developed and implemented an iterative research agenda that has utilized accumulated experience and datasets from several multicenter clinical trials and large cohort studies. This work has led to the development, evaluation, validation, and endorsement, through the OMERACT consensus and validation processes, of a “core set” of outcome measurements for use in clinical trials of AAV. The core set includes domains of disease activity, damage assessment, patient-reported outcomes, and mortality; there is at least one validated outcome measurement instrument available for each domain. This report reviews the domains of illness in AAV included in the OMERACT core set, describes the instruments validated to measure these domains, and presents the approved core set.

scholarly journals Viral Causes of Hearing Loss: A Review for Hearing Health Professionals

2014 ◽  
Vol 18 ◽  
pp. 233121651454136 ◽  
Author(s):  
Brandon E. Cohen ◽  
Anne Durstenfeld ◽  
Pamela C. Roehm
Keyword(s):  
Hearing Loss ◽  
Health Professionals ◽  
Hearing Health

More on T & A

PEDIATRICS ◽  
1977 ◽  
Vol 59 (4) ◽  
pp. 641-642
Author(s):  
Jack L. Paradise
Keyword(s):  
Clinical Trials ◽  
Health Professionals ◽  
Current Knowledge ◽  
Research Question ◽  
Essential Nature ◽  
Scientific Status

The treatment of three important issues relating to tonsillectomy and adenoidectomy (T & A)—(1) the essential nature of the T & A research question, (2) certain ethical requirements of clinical trials of T & A, and (3) the advisability of T & A in the light of current knowledge—in the review by Shaikh et al.1 calls for comment. Nature of the Research Question. For health professionals concerned with the T & A problem, clarity about the scientific status of T & A is important.

Recruitment and retention in clinical trials in chronic kidney disease: report from national workshops with patients, caregivers and health professionals

2020 ◽  
Vol 35 (5) ◽  
pp. 755-764 ◽  
Author(s):  
Patrizia Natale ◽  
Talia Gutman ◽  
Martin Howell ◽  
Kathryn Dansie ◽  
Carmel M Hawley ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Clinical Trials ◽  
Kidney Disease ◽  
Health Professionals ◽  
Statistical Power ◽  
Research Question ◽  
Trial Participation ◽  
Optimal Timing ◽  
Recruitment And Retention ◽  
Effective Interventions

Abstract Background Slow recruitment and poor retention jeopardize the reliability and statistical power of clinical trials, delaying access to effective interventions and increasing costs, as commonly observed in nephrology trials. Involving patients in trial design, recruitment and retention is infrequent but potentially transformational. Methods We conducted three workshops involving 105 patients/caregivers and 43 health professionals discussing patient recruitment and retention in clinical trials in chronic kidney disease. Results We identified four themes. ‘Navigating the unknown’—patients described being unaware of the research question, confused by technical terms, sceptical about findings and feared the risk of harm. ‘Wary of added burden’—patients voiced reluctance to attend additional appointments, were unsure of the commitment required or at times felt too unwell and without capacity to participate. ‘Disillusioned and disconnected’—some patients felt they were taken for granted, particularly if they did not receive trial results. Participants believed there was no culture of trial participation in kidney disease and an overall lack of awareness about opportunities to participate. To improve recruitment and retention, participants addressed ‘Building motivation and interest’. Conclusions Investigators should establish research consciousness from the time of diagnosis, consider optimal timing for approaching patients, provide comprehensive information in an accessible manner, emphasize current and future relevance to them and their illness, involve trusted clinicians in recruitment and minimize the burden of trial participation. Participation in clinical trials was seen as an opportunity for people to give back to the health system and for future people in their predicament.

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