scholarly journals Stakeholder perspectives regarding pragmatic clinical trial collateral findings

2020 ◽  
Author(s):  
Stephanie R. Morain ◽  
Debra J. H. Mathews ◽  
Kevin Weinfurt ◽  
Elizabeth May ◽  
Juli M. Bollinger ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pragmatic Clinical Trial ◽  
Stakeholder Perspectives ◽  
Collateral Findings

Pragmatic Clinical Trial-Collateral Findings: Recognizing the Needs of Low-Resource Research Participants

2020 ◽  
Vol 20 (1) ◽  
pp. 19-21
Author(s):  
Courtney A. Stewart ◽  
Kayla E. Cooper ◽  
Megan B. Raymond ◽  
Faith E. Fletcher ◽  
Vence L. Bonham
Keyword(s):  
Clinical Trial ◽  
Pragmatic Clinical Trial ◽  
Low Resource ◽  
Research Participants ◽  
Collateral Findings ◽  
Resource Research

Identification and management of pragmatic clinical trial collateral findings: A current understanding and directions for future research

Healthcare ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 100586
Author(s):  
Stephanie R. Morain ◽  
Debra J.H. Mathews ◽  
Gail Geller ◽  
Juli Bollinger ◽  
Kevin Weinfurt ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Current Understanding ◽  
Future Research ◽  
Pragmatic Clinical Trial ◽  
Collateral Findings ◽  
A Current

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 ‘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

Sign in / Sign up

Export Citation Format

Share Document