Methodological approaches for conducting follow-up research with clinical trial participants: a scoping review and expert interviews

Abstract Background Evidence-based establishment and implementation of best principles, laws and ordinances that regulate clinical research depend on the consultation and involvement of trial participants. Yet, guidance on methodological approaches to obtain trial participants’ perspectives is currently missing. This scoping review therefore aimed at identifying, describing and evaluating research approaches to obtain trial participants’ feedback on their views and experiences. Methods We searched the electronic databases Medline and PsycInfo via Ovid and the Web of Science Core Collection. Clinical trials were included that involved adult participants that were conducted in selected high-income countries and that were published in peer-reviewed journals between 1985 and 2018. In addition, 29 expert interviews were conducted between March and May 2019. Results Out of 5994 identified records, 23 articles were included in this review. Twelve studies used a qualitative approach, 10 were quantitative and one study used a mixed-method design. More than 75% of all work was conducted in the USA and the UK. The scoping review and the expert interviews highlighted that recruitment of participants was generally done through direct contact by principal investigators and/or study nurses or through searches in de-identified patient databases. Authors used surveys, interviews or focus group discussions. The tools used were either based on existing validated ones or developed and verified de novo with the support of experts and/or patient representatives. Conclusions To our knowledge, this is the first methodological literature review of approaches to researching experiences of clinical trial participants where findings were triangulated with expert interviews. Covering a range of indications, trial phases and study settings, it demonstrates that clinical trial participant perspectives and experience is heavily under-researched. This casts doubt on the overall robustness of available insight into trial participants’ views and experiences. Our results demonstrate that the methodology for studying participant opinion, perception and experience should be adapted to the measure of interest and conform to the study population. Using valid patient experience data is the basis to evaluate existing legal and regulatory human subject research frameworks for their appropriateness from a patient perspective. Such an evaluation will be critical to empower research participants.

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Key components and IT assistance of participant management in clinical research: a scoping review

JAMIA Open ◽

10.1093/jamiaopen/ooaa041 ◽

2020 ◽

Vol 3 (3) ◽

pp. 449-458

Author(s):

Johannes Pung ◽

Otto Rienhoff

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Clinical Research ◽

Computer Assisted ◽

Trial Participant ◽

Comprehensive Overview ◽

Definition Of ◽

Meta Analyses ◽

Assisted Management ◽

Trial Participants

Abstract Objectives Managing participants and their data are fundamental for the success of a clinical trial. Our review identifies and describes processes that deal with management of trial participants and highlights information technology (IT) assistance for clinical research in the context of participant management. Methods A scoping literature review design, based on the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement, was used to identify literature on trial participant-related proceedings, work procedures, or workflows, and assisting electronic systems. Results The literature search identified 1329 articles of which 111 were included for analysis. Participant-related procedures were categorized into 4 major trial processes: recruitment, obtaining informed consent, managing identities, and managing administrative data. Our results demonstrated that management of trial participants is considered in nearly every step of clinical trials, and that IT was successfully introduced to all participant-related areas of a clinical trial to facilitate processes. Discussion There is no precise definition of participant management, so a broad search strategy was necessary, resulting in a high number of articles that had to be excluded. Nevertheless, this review provides a comprehensive overview of participant management-related components, which was lacking so far. The review contributes to a better understanding of how computer-assisted management of participants in clinical trials is possible.

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Selective laser trabeculoplasty (SLT) performed by optometrists for patients with glaucoma and ocular hypertension: a scoping review

BMJ Open Ophthalmology ◽

10.1136/bmjophth-2020-000611 ◽

2021 ◽

Vol 6 (1) ◽

pp. e000611

Author(s):

Lee Jones ◽

Evgenia Konstantakopoulou ◽

Gus Gazzard

Keyword(s):

Ocular Hypertension ◽

Scoping Review ◽

Grey Literature ◽

Clinical Effectiveness ◽

Selective Laser Trabeculoplasty ◽

Training Requirements ◽

Laser Trabeculoplasty ◽

The Usa ◽

Training Programmes ◽

The Uk

Selective laser trabeculoplasty (SLT) has been established as an effective treatment to lower intraocular pressure in people with glaucoma and ocular hypertension. The procedure is typically within the remit of ophthalmologists; however, there is potential to upskill optometrists and other healthcare professionals (HCPs) to deliver the treatment. We conducted a scoping review to identify the current global landscape of HCP-delivered SLT and describe training features, clinical effectiveness and safety. Relevant articles were identified through online database searches and grey literature sources. Four articles were selected for full inclusion. This review identified training programmes for optometrist-delivered SLT in the UK and the USA. The findings indicate that more research is needed to clarify training requirements and clinical effectiveness.

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A Delphi study of late-onset personality disorders

International Psychogeriatrics ◽

10.1017/s1041610218001473 ◽

2019 ◽

Vol 31 (07) ◽

pp. 1007-1013 ◽

Cited By ~ 3

Author(s):

Erlene Rosowsky ◽

Emily Lodish ◽

James M. Ellison ◽

S. P. J. van Alphen

Keyword(s):

Personality Disorders ◽

Old Age ◽

Assisted Living ◽

Delphi Study ◽

De Novo ◽

Late Onset ◽

Late Life ◽

The Core ◽

The Usa ◽

The Uk

ABSTRACTObjectives:The DSM-5 describes personality disorders (PDs) as emerging in early life and remaining continuous throughout the life-span. Yet case studies and expert opinion support the existence of late-onset PDs. Little is known about PDs in late life, and our instruments for assessing them are not well validated. Thus, the focus of this exploratory Delphi study was the late-onset PD, with special attention to the accuracy of the core criteria for the diagnosis.Design:A Delphi study was designed to assess the presentation of PDs in late life. The Delphi consisted of three successive rounds of inquiry. Between rounds, the participants were provided with a summary of the panel’s responses.Participants:A panel of 21 experts included published authors, researchers, and teachers from the USA, the UK, Australia, France, Belgium, and the Netherlands.Measurements:Researchers designed a survey that included an introduction, a demographic questionnaire, and five questions that varied in presentation and response format.Results:Experts reached consensus that a variant of PD appears de novo in old age. The core features of inflexibility and pervasiveness may not pertain to late-onset PD. There was agreement that frequently occurring life events contribute selectively to the expression of late-onset PD, with the major ones being death of a spouse or partner and transition to a nursing or assisted-living facility.Conclusions:Nearly all participants took the position that PD can present for the first time in old age and be clinically identifiable without having been so identified earlier in life.

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An early mainstream economist from Hungary: István Varga (1897–1962)

Acta Oeconomica ◽

10.1556/aoecon.53.2003.2.4 ◽

2003 ◽

Vol 53 (2) ◽

pp. 195-213 ◽

Cited By ~ 1

Author(s):

K. Majoros

Keyword(s):

Austrian Economic ◽

National Income ◽

Anglo Saxon ◽

Turbulent Times ◽

The Usa ◽

New Ideas ◽

Modern Economic ◽

The Uk ◽

Economic Thinking ◽

Lasting Influence

The study introduces a Hungarian economic thinker, István Varga*, whose valuable activity has remained unexplored up to now. He became an economic thinker during the 1920s, in a country that had not long before become independent of Austria. The role played by Austria in the modern economic thinking of that time was a form of competition with the thought adhered to by the UK and the USA. Hungarian economists mainly interpreted and commented on German and Austrian theories, reasons for this being that, for example, the majority of Hungarian economists had studied at German and Austrian universities, while at Hungarian universities principally German and Austrian economic theories were taught. István Varga was familiar not only with contemporary German economics but with the new ideas of Anglo-Saxon economics as well — and he introduced these ideas into Hungarian economic thinking. He lived and worked in turbulent times, and historians have only been able to appreciate his activity in a limited manner. The work of this excellent economist has all but been forgotten, although he was of international stature. After a brief summary of Varga’s profile the study will demonstrate the lasting influence he has had in four areas — namely, business cycle research and national income estimations, the 1946 Hungarian stabilisation program, corporate profit, and consumption economics — and will go on to summarise his most important achievements.

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Effect of new dietary supplement on sperm quality

Orvosi Hetilap ◽

10.1556/oh.2012.29468 ◽

2012 ◽

Vol 153 (45) ◽

pp. 1787-1792 ◽

Cited By ~ 1

Author(s):

Mária Horváth ◽

Endre Czeizel

Keyword(s):

Adverse Effect ◽

Clinical Trial ◽

Dietary Supplement ◽

Male Fertility ◽

Sperm Quality ◽

Sperm Count ◽

Before And After ◽

The Usa ◽

New Treatments

Introduction: There is a decline in male fertility thus new treatments are needed. Aims: To test the efficacy of a new dietary supplement developed in the USA and registered as a curing drug in Hungary (OGYI). Methods: In a clinical trial 100 men with low sperm quality (spermium count 5–20 M/ml, good motility 10–40%, and adverse shape 30–50%) were examined. Results: Sperm parameters were measured before and after a 3-month treatment and after another 3-month without treatment. This dietary supplement statistically and clinically significantly improved sperm count and motility. In 74 cases this dietary supplement demonstrated a beneficial effect on sperm quality (more than 10% increase in sperm count, or quality of motility, or shape); in 16 cases the improvement exceeded 30%. No adverse effect could be accounted for this treatment. Conclusions: This new dietary supplement may contribute to the treatment of male infertility. Orv. Hetil., 2012, 153, 1787–1792.

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