How sample size influences research outcomes

Faber, Jorge; Fonseca, Lílian Martins

doi:10.1590/2176-9451.19.4.027-029.ebo

Cited by 517 publications

(288 citation statements)

References 2 publications

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“…Only five protocols (2.99%) were RCTs designed to target older adults exclusively, which is in accordance with a type 2 diabetes systematic review of trials registry that found 1.4% of the eligible studies were designed for older adults . Further, the five protocols planned exclusively for older adults in our review are small representing less than 1% of the sample from all eligible studies (n = 169/31 199), which generates a clinical and ethical issue . CTs with a small sample may present insufficient statistical power and may not answer properly the tested hypothesis exposing participants to unnecessary risks and burdens in research with limited clinical value .…”

Section: Discussionsupporting

confidence: 59%

“…44 Further, the five protocols planned exclusively for older adults in our review are small representing less than 1% of the sample from all eligible studies (n = 169/31 199), which generates a clinical and ethical issue. 45,46 CTs with a small sample may present insufficient statistical power and may not answer properly the tested hypothesis exposing participants to unnecessary risks and burdens in research with limited clinical value. 46,47 In addition, studies with a small sample size have a poor generalizability of their results.…”

Section: Discussionmentioning

confidence: 99%

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Exclusion of Older Adults from Ongoing Clinical Trials on Low Back Pain: A Review of the WHO Trial Registry Database

Nascimento

Ferreira

Poitras

et al. 2018

J American Geriatrics Society

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Background/Objectives The burden of low back pain (LBP) is high, especially for older adults who experience a higher number of years living with a disability. However, this population is not being well represented in clinical trials (CTs). This study analyzed the International Clinical Trial Registry Platform (ICTRP) database from the World Health Organization to verify the future trend in the participation of older adults in registered CTs on LBP. Design We performed a cross‐sectional review of the ICTRP searching for prospective protocols planning interventions for LBP with registration dates from January 2015 through November 2018. From the protocols of the eligible studies, we extracted those planning to include older adults. Results A total of 167 protocols for CTs for LBP were planning to recruit participants older than 65 years. However, only five registries (2.99%; pooled sample = 169 participants) were designed to target participants specifically older than 65 years. The exclusion of older participants was not justified and imposed through an arbitrary upper‐age limit in 93.6% of the protocols. Most of the protocols are from single‐center studies, and a greater number are planned to be carried out in developed regions. Higher interest was in pharmacologic interventions, devices/technology, and physical rehabilitation. Conclusion Older adults with LBP will continue to be underinvestigated in CTs for LBP in the near future. In general, ongoing trials are small, planned in developed regions, and proposing pharmacologic interventions to deal with LBP. J Am Geriatr Soc 67:603–608, 2019.

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Section: Discussionsupporting

confidence: 59%

Section: Discussionmentioning

confidence: 99%

Exclusion of Older Adults from Ongoing Clinical Trials on Low Back Pain: A Review of the WHO Trial Registry Database

Nascimento

Ferreira

Poitras

et al. 2018

J American Geriatrics Society

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“…In this study, mirror visual feedback of the isometrically training limb did not augment cross‐education of strength. Small sample sizes often prevent the detection of statistically significant results, causing Type II errors (Faber & Fonseca, ). Even though the between group difference for change in walking velocity in favour of the MST group did not quite reach statistical significance ( p = 0.055, d = 0.7), in a pilot study with a small sample size this may be considered an interesting finding worthy of further investigation.…”

Section: Discussionmentioning

confidence: 99%

Unilateral dorsiflexor strengthening with mirror therapy to improve motor function after stroke: A pilot randomized study

Simpson

Ehrensberger

Horgan

et al. 2019

Physiotherapy Res Intl

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Background Independently, cross‐education, the performance improvement of the untrained limb following unilateral training, and mirror therapy have shown to improve lower limb functioning poststroke. Mirror therapy has shown to augment the cross‐education effect in healthy populations. However, this concept has not yet been explored in a clinical setting. Objectives This study set out to investigate the feasibility and potential efficacy of applying cross‐education combined with mirror therapy compared with cross‐education alone for lower limb recovery poststroke. Methods Thirty‐one chronic stroke participants (age 61.7 ± 13.3) completed either a unilateral strength training (ST; n = 15) or unilateral strength training with mirror‐therapy (MST; n = 16) intervention. Both groups isometrically strength trained the less‐affected ankle dorsiflexors three times per week for 4 weeks. Only the MST group observed the mirror reflection of the training limb. Patient eligibility, compliance, treatment reliability, and outcome measures were assessed for feasibility. Maximal voluntary contraction (MVC; peak torque, rate of torque development, and average torque), 10‐m walk test, timed up and go (TUG), Modified Ashworth Scale (MAS), and the London Handicap Scale (LHS) were assessed at pretraining and posttraining. Results Treatment and assessments were well tolerated without adverse effects. No between group differences were identified for improvement in MVC, MAS, TUG, or LHS. Only the combined treatment was associated with functional improvements with the MST group showing an increase in walking velocity. Conclusion Cross‐education plus mirror therapy may have potential for improving motor function after stroke. This study demonstrates the feasibility of the combination treatment and the need for future studies with larger sample sizes to investigate the effectiveness of the treatment.

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“…As the number of individuals living with a particular disease is relatively small-and there are a significant number of rare conditions-an array of challenges complicates the knowledge development in this area of study (Institute of Medicine Committee on Accelerating Rare Diseases Research & Orphan Products, 2010). These challenges make it difficult for researchers to recruit an adequate number of patients to reach scientifically valid conclusions (Faber & Fonseca, 2014;Gupta, 2012). These challenges make it difficult for researchers to recruit an adequate number of patients to reach scientifically valid conclusions (Faber & Fonseca, 2014;Gupta, 2012).…”

Section: R Are D Is E a S E Re S E Archmentioning

confidence: 99%

Objectivity in rare disease research: A philosophical approach

2019

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Individuals living with rare conditions are faced with important challenges derived from the rarity of their conditions and aggravated by the low priority given to rare disease research. However, current realities of rare disease research require consideration of the relationship between subjectivity and 'traditional' objectivity.Objectivity in research has traditionally been associated with processes and descriptions that are independent of the investigator. The need for researchers to provide unbiased knowledge and achieve a balance between objectivity and the underlying values in nursing and scientific research requires an examination of how objectivity is conceptualized within the context of rare disease research. The aim of this paper is to examine scientific objectivity in rare disease research from a philosophical viewpoint and, in doing so, demonstrate the need to redefine it to reflect the current scientific environment. As such, healthcare providers working on this field need to redefine objectivity around ethical and moral obligation to advance science in an equitable manner with the end goal to produce knowledge that is trustworthy and beneficial to our patients. K E Y W O R D Sethics, moral, nursing practice, philosophy, philosophy of science, research implementation, research in practice

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How sample size influences research outcomes

Cited by 517 publications

References 2 publications

Exclusion of Older Adults from Ongoing Clinical Trials on Low Back Pain: A Review of the WHO Trial Registry Database

Exclusion of Older Adults from Ongoing Clinical Trials on Low Back Pain: A Review of the WHO Trial Registry Database

Unilateral dorsiflexor strengthening with mirror therapy to improve motor function after stroke: A pilot randomized study

Objectivity in rare disease research: A philosophical approach

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