Definition of a Pragmatic Clinical Trial

10.28929/090 ◽  
2017 ◽  
Author(s):  
Kevin Weinfurt
Keyword(s):  
Clinical Trial ◽  
Pragmatic Clinical Trial ◽  
Definition Of

scholarly journals Occupational therapy and psychosis: POINTER feasibility study for a pragmatic clinical trial

2021 ◽  
pp. 030802262110002
Author(s):  
Joanne Inman ◽  
Katrina Bannigan ◽  
Jacqueline Akhurst
Keyword(s):  
Clinical Trial ◽  
Occupational Therapy ◽  
Everyday Life ◽  
Short Form ◽  
Outcome Measurement ◽  
Performance Measure ◽  
Drop Out ◽  
Secondary Outcome ◽  
Occupational Performance ◽  
Pragmatic Clinical Trial

Introduction The dearth of clinical trials of individualised occupational therapy with people with a diagnosis of psychosis limits the evidence base globally for occupational therapy practice. This study evaluated the feasibility of conducting a pragmatic clinical trial. Method Mixed methods design using a pragmatic perspective; two-centre, one-group pretest-posttest study, at six months. POINTER Occupational Intervention Specification captured routine individualised occupational therapy. Process evaluation included recruitment, retention, intervention delivery, fidelity, adherence and outcome measurement. The primary outcome was participation in activities of everyday life, measured by Time Use Survey, Participation Scale and Utrecht Scale for Evaluation of Rehabilitation-Participation. The Canadian Occupational Performance Measure measured self-reported experience of and satisfaction with occupational performance. The Short Form-36v2 Health Survey measured health-related quality of life, a secondary outcome. Participants’ experiences were explored using a questionnaire. Intervention providers’ perspectives were investigated via the POINTER occupational intervention log and focus groups. Results Recruitment was (20/36) and drop-out 20% (4/20). Fidelity was 77%, and adherence was good; POINTER had validity and utility. Outcome measurement was acceptable to participants, indicating increased participation in activities of everyday life. Conclusion A larger clinical trial is merited; recruitment processes need further exploration, and outcome measurement needs refining.

scholarly journals A single whole body vibration session influences quadriceps muscle strength, functional mobility and balance of elderly with osteopenia and/or osteoporosis? Pragmatic clinical trial

2019 ◽  
Vol 18 (1) ◽  
pp. 73-80
Author(s):  
Luanda Alves Xavier Ramos ◽  
François Talles Medeiros Rodrigues ◽  
Lívia Shirahige ◽  
Maria de Fátima Alcântara Barros ◽  
Antônio Geraldo Cidrão de Carvalho ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Muscle Strength ◽  
Whole Body Vibration ◽  
Quadriceps Muscle ◽  
Functional Mobility ◽  
Whole Body ◽  
Pragmatic Clinical Trial ◽  
Body Vibration ◽  
Quadriceps Muscle Strength

scholarly journals A3-4: Implementing a Pragmatic Clinical Trial: Lessons Learned about Embedded Research

2014 ◽  
Vol 12 (1-2) ◽  
pp. 90-91
Author(s):  
L. Kindler ◽  
C. McMullen ◽  
A. Owen-Smith ◽  
S. Honda ◽  
A. Firemark ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lessons Learned ◽  
Pragmatic Clinical Trial

scholarly journals Practical and conceptual issues of clinical trial registration for Brazilian researchers

2015 ◽  
Vol 134 (1) ◽  
pp. 28-33 ◽  
Author(s):  
Carolina Gomes Freitas ◽  
Thomas Fernando Coelho Pesavento ◽  
Maurício Reis Pedrosa ◽  
Rachel Riera ◽  
Maria Regina Torloni
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
International Committee ◽  
New Drugs ◽  
Trial Registration ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Registration Process ◽  
Trial History ◽  
Definition Of

CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

Randomized controlled trials

2020 ◽  
pp. 187-218
Author(s):  
Sube Banerjee ◽  
Rod S. Taylor ◽  
Jennifer Hellier
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trials ◽  
Complex Interventions ◽  
Controlled Trials ◽  
Key Factors ◽  
Randomized Controlled ◽  
Study Population ◽  
Primary Hypothesis ◽  
Definition Of

This chapter on randomized controlled trials (RCTs) considers some of the key factors in the design, conduct, analysis, and interpretation of RCTs. The chapter provides an overview of what constitutes an RCT and why they are needed. The chapter also provides an overview of the major practical elements of the design and conduct of RCTs, including undertaking a background review of literature, the need for formulation of a clear primary hypothesis and objective, selection and definition of the study population, collecting outcomes at baseline and follow-up, and appropriate methods of statistical analysis and inference. The chapter concludes with a consideration of the need for clinical trial units, complex interventions, and alternative RCT designs.

scholarly journals ‘Mothers moving towards empowerment’ intervention to reduce stigma and improve treatment adherence in pregnant women living with HIV in Botswana: study protocol for a pragmatic clinical trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Ohemaa B. Poku ◽  
Ari R. Ho-Foster ◽  
Patlo Entaile ◽  
Supriya Misra ◽  
Haitisha Mehta ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pregnant Women ◽  
Treatment Adherence ◽  
Hiv Stigma ◽  
Stigma Reduction ◽  
Pragmatic Clinical Trial ◽  
Improve Treatment ◽  
Culturally Based ◽  
Living With Hiv ◽  
Pregnant Mothers

Abstract Background With high rates of HIV and multiple vulnerable subgroups across diverse settings, there is a need for culturally based, HIV stigma reduction interventions. Pregnant women who are living with HIV are especially in need of services to protect not only their own but also their children’s lives. Uptake of HIV services worldwide is hindered by stigma towards persons living with HIV/AIDS. While cultural context plays a key role in shaping HIV stigma, these insights have not yet been fully integrated into stigma reduction strategies. By utilizing the “What Matters Most” stigma framework, we propose that an intervention to counter culturally salient aspects of HIV stigma will improve treatment adherence and other relevant outcomes. A pragmatic clinical trial in Botswana will evaluate the “Mothers Moving towards Empowerment” (MME) intervention, which seeks to address HIV stigma in Botswana and to specifically engage pregnant mothers so as to promote antiretroviral therapy (ART) adherence in the postpartum period. Methods This study will test MME against treatment as usual (TAU) among pregnant mothers diagnosed with HIV and their infants. Outcomes will be assessed during pregnancy and 16 weeks postpartum. Women who meet eligibility criteria are assigned to MME or TAU. Women assigned to MME are grouped with others with similar estimated delivery dates, completing up to eight intervention group sessions scheduled before week 36 of their pregnancies. Primary outcomes among mothers include (i) reducing self-stigma, which is hypothesized to mediate improvements in (ii) psychological outcomes (quality of life, depression and social functioning), and (iii) adherence to antenatal care and ART. We will also examine a set of follow-up infant birth outcomes (APGAR score, preterm delivery, mortality (at < 16 weeks), birth weight, vaccination record, and HIV status). Discussion Our trial will evaluate MME, a culturally based HIV stigma reduction intervention using the “What Matters Most” framework, to reduce stigma and improve treatment adherence among pregnant women and their infants. This study will help inform further refinement of MME and preparation for a future large-scale, multisite, randomized controlled trial (RCT) in Botswana. Trial registration ClinicalTrials.gov NCT03698981. Registered on October 8, 2018

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