scholarly journals The Importance of Risk and Subgroup Analysis of Nonparticipants in a Geriatric Intervention Study

Scientifica ◽  
2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Elizabeth Rosted ◽  
Ingrid Poulsen ◽  
Carsten Hendriksen ◽  
Lis Wagner
Keyword(s):  
Randomized Controlled Trial ◽  
Older People ◽  
Intervention Studies ◽  
Controlled Trial ◽  
Randomized Study ◽  
University Hospital ◽  
Randomized Controlled ◽  
Emergency Department Stay ◽  
Geriatric Intervention ◽  
Patient Groups

Background. A major concern in intervention studies is the generalizability of the findings due to refusal of intended participants to actually take part. In studies including ill older people the number of those declining to participate may be large and the concern is therefore relevant.Objectives. To compare patients characteristics, rates of acute readmission, and mortality after one and six months among older persons who agreed and those who declined to participate in a randomized controlled trial and to describe subgroups of nonparticipants.Design. Comparative study based on a randomized controlled trial.Setting. University hospital in the Capital Region of Denmark.Participants. Patients ≥70 years discharged home after a short Emergency Department stay. 399 were requested to participate; 271 consented, whereas 128 refused.Results. Refusers were more likely to be readmitted (p<0.001) or die (p=0.006). The largest subgroup of refusers described as “too ill” had the highest risk of readmission (OR = 3.00, 95% CI = 1.61–5.47,p=0.001) and of mortality within six months (OR = 3.50, 95% CI = 1.64–7.49,p=0.002). However, this seems not to have affected the results of our randomized study.Conclusion. We recommend that intervention studies among older people or other fragile patient groups include analysis of relevant risk and subgroup analyses of refusers.

Preventing Falls in Older People: Outcome Evaluation of a Randomized Controlled Trial

2001 ◽  
Vol 49 (11) ◽  
pp. 1448-1455 ◽  
Author(s):  
Margaret Stevens ◽  
C. D'Arcy J. Holman ◽  
Nicole Bennett ◽  
Nick De Klerk
Keyword(s):  
Randomized Controlled Trial ◽  
Older People ◽  
Controlled Trial ◽  
Outcome Evaluation ◽  
Randomized Controlled

scholarly journals Stage 2 Acupuncture for Poor Ovarian Response: A Randomized Controlled Trial

2021 ◽  
Vol 10 (10) ◽  
pp. 2182
Author(s):  
Jihyun Kim ◽  
Hoyoung Lee ◽  
Tae-Young Choi ◽  
Joong Il Kim ◽  
Byoung-Kab Kang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Ovarian Response ◽  
Controlled Ovarian Hyperstimulation ◽  
University Hospital ◽  
Ovarian Hyperstimulation ◽  
Poor Ovarian Response ◽  
Vitro Fertilization ◽  
Randomized Controlled

Acupuncture is believed to improve ovarian reserve and reproductive outcomes in women undergoing in vitro fertilization (IVF). This study was conducted to evaluate the effect of network-optimized acupuncture followed by IVF on the oocyte yield in women showing a poor ovarian response. This study was an exploratory randomized controlled trial conducted from June 2017 to January 2020 at the Pusan National University Hospital. Women diagnosed with poor ovarian response were enrolled and randomly divided into two groups: IVF alone and Ac + IVF groups (16 acupuncture sessions before IVF treatment). Eight acupoints with high degree centrality and betweenness centrality were selected using network analysis. Among the participants, compared with the IVF treatment alone, the acupuncture + IVF treatment significantly increased the number of retrieved mature oocytes in women aged more than 37 years and in those undergoing more than one controlled ovarian hyperstimulation cycle. The negative correlation between the number of retrieved mature oocytes and consecutive controlled ovarian hyperstimulation cycles was not observed in the Ac + IVF group irrespective of the maternal age. These findings suggest that physicians can consider acupuncture for the treatment of women with poor ovarian response and aged > 37 years or undergoing multiple IVF cycles.

scholarly journals Beraprost Sodium for Chronic Diabetic Foot Ulcer: A Randomized Controlled Trial in Thammasat University Hospital

2014 ◽  
Vol 7 (1) ◽  
pp. 40-45 ◽  
Author(s):  
Surajit Awsakulsutthi ◽  
Kwanjit Punpho ◽  
Jinpitcha Mamom ◽  
Pairat Baikrut ◽  
Patcharee Yingchoorod
Keyword(s):  
Randomized Controlled Trial ◽  
Diabetic Foot ◽  
Controlled Trial ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
University Hospital ◽  
Randomized Controlled ◽  
Beraprost Sodium

scholarly journals The effect of walking on falls in older people: the 'Easy Steps to Health' randomized controlled trial study protocol

2011 ◽  
Vol 11 (1) ◽  
Author(s):  
Alexander Voukelatos ◽  
Dafna Merom ◽  
Chris Rissel ◽  
Cathie Sherrington ◽  
Wendy Watson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Older People ◽  
Study Protocol ◽  
Controlled Trial ◽  
Randomized Controlled

Effects of an Individualized Exercise Program Plus Behavioral Change Enhancement Strategies for Managing Fatigue in Older People Who Are Frail: Protocol for a Cluster Randomized Controlled Trial

2019 ◽  
Vol 99 (12) ◽  
pp. 1616-1627
Author(s):  
Justina Y W Liu ◽  
Patrick P K Kor ◽  
Paul L Lee ◽  
Wai T Chien ◽  
Parco M Siu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Exercise Training ◽  
Older People ◽  
Behavioral Change ◽  
Controlled Trial ◽  
Exercise Program ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
General Fatigue ◽  
Cluster Randomized

Abstract Background Although the evidence suggests that general fatigue is a strong indicator of rapid aging, frailty, and disability, general fatigue is undertreated in gerontological care. Objective The aim of this study is to investigate whether an individualized exercise program with and without behavioral change enhancement (BCE) strategies for older people who are frail and have general fatigue will reduce their fatigue and symptoms of frailty. Design A 3-arm, single-blind, cluster randomized controlled trial registered with ClinicalTrials.gov (NCT03394495) will be conducted. Setting The study will be conducted in a community setting. Participants Two hundred eighty-five community-dwelling older people with general fatigue will be recruited from 12 district community health centers. Intervention People from each center will be randomized to one of three groups. The combined group will receive a 16-week combined intervention consisting of individualized exercise training and the BCE program, plus two booster sessions at 2 and 6 months after the program. The exercise group will receive exercise training and health talks only. The control group will receive health talks only. Measurements Outcome measures will be collected at baseline, at the midpoint (week 8) of the program, and then at 1 week, 6 months, and 12 months after the end of the program. The primary outcome---level of fatigue---will be measured using the Multidimensional Fatigue Inventory. Secondary outcomes will include the participants’ frailty status, strength, mobility, exercise self-efficacy, and habitual physical activity. Limitations A self-reported level of fatigue will be used. Conclusions The effect of exercise and BCE strategies on general fatigue among older people who are frail is not known. This study will be a pioneering interventional study on how general fatigue among older people who are frail can be managed and how fatigue-related frailty can be prevented or minimized.

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