Sufficiently Important Difference: Expanding the Framework of Clinical Significance

Barrett, Bruce; Brown, David; Mundt, Marlon; Brown, Roger

doi:10.1177/0272989x05276863

Cited by 160 publications

(159 citation statements)

References 70 publications

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“…13 At the completion of the trial, participants were asked to rate perceived Global Impression of Change in both the treated and untreated ankle using a 15-point Likert scale where À7 indicates 'very great deal worse', 0 indicates 'no change' and þ 7 indicates 'very great deal better'. 14 In addition, participants were asked to rate the convenience or inconvenience of the intervention on a 10 cm visual analogue scale. At one end of the 10 cm scale were the words 'very inconvenient' and at the other end were the word 'not at all inconvenient'.…”

Section: Measurementmentioning

confidence: 99%

Effects of 6 months of regular passive movements on ankle joint mobility in people with spinal cord injury: a randomized controlled trial

et al. 2008

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Study design: Assessor-blinded within-subject randomized controlled trial. Objective: To determine the effects of 6 months of regular passive movements on ankle joint mobility in people with spinal cord injury. Setting: Community, Australia. Methods: A total of 20 people with tetraplegia living in the community had one ankle randomized to a control group and the other to an experimental group. Carers administered passive movements to participants' experimental ankles for 10 min, 10 times a week for 6 months. The control ankles were left untreated. The primary outcome was passive ankle dorsiflexion range of motion. Results: Adherence was high (mean adherence rate of 96%). Ankle dorsiflexion range of motion decreased by a mean (s.d.) of 21 (4) in control ankles and increased by 21 (4) in experimental ankles. The mean (95% confidence interval, CI) effect on ankle dorsiflexion range of motion was 41 (95% CI, 2-61). Conclusion: Regular passive movements have small effects on ankle joint mobility. It is unclear if these effects are clinically worthwhile.

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Section: Measurementmentioning

confidence: 99%

Effects of 6 months of regular passive movements on ankle joint mobility in people with spinal cord injury: a randomized controlled trial

et al. 2008

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“…This concept is important because it shifts the emphasis in clinical trials from P-values to the size of treatment effects. 3,22 Obviously, the sufficiently important difference would depend on the circumstances, participants and intervention. 3,11,18 Clinicians' and patients' impressions of change could also be used in other areas of research.…”

Section: Discussionmentioning

confidence: 99%

“…3,22 Obviously, the sufficiently important difference would depend on the circumstances, participants and intervention. 3,11,18 Clinicians' and patients' impressions of change could also be used in other areas of research. For example, they could be used to define sufficiently important differences for objective outcome measures such as the Walking Index for SCI and Clinical Outcome Variables Scale.…”

Section: Discussionmentioning

confidence: 99%

“…A possible solution is to ask clinicians and patients to rate their overall impressions of change over time on a 15-point global impression of change scale anchored with 'a very great deal better' at one end ( þ 7) and 'a very great deal worse' (À7) at the other. 3,4 Impressions of change are commonly used as part of clinical trials in gerontology [5][6][7] and psychiatry, 6,8 but only rarely in SCI. 9,10 Although clinicians' and patients' impressions of change are subjective, they are nonetheless valuable and reflect the way clinical decisions are made in practice about ceasing, commencing or changing therapy.…”

Section: Introductionmentioning

confidence: 99%

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Clinicians’ and patients’ impressions of change in motor performance as potential outcome measures for clinical trials

et al. 2010

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Study design: A cross-sectional descriptive study was undertaken. Objectives: The overall objective was to explore the potential usefulness of clinicians' and patients' impressions of change in motor performance for clinical trials. Specifically, the aim was to compare clinicians' and patients' impressions of change in motor performance with standardized outcome measures in people with spinal cord injury (SCI). Setting: Spinal injury units, Sydney, Australia. Methods: Thirty people undergoing rehabilitation after recent SCI were recruited. They were assessed on two occasions separated by between 1 and 5 months. On both occasions, patients were assessed sitting unsupported (n ¼ 25), transferring (n ¼ 23) and walking (n ¼ 12) using standardized outcome measures. On the second occasion, patients rated their impressions of change in each of the three motor tasks since their initial assessment. A 15-point scale was used. In addition, patients were videoed performing the three motor tasks on the two occasions. Two clinicians with SCI experience independently viewed the pairs of videos and rated their impressions of change using the same 15-point scale. Clinicians' and patients' impressions of change were compared with each other and to the standardized objective measures. Results: Clinicians' and patients' impressions of change were greater than change measured with standardized objective measures for all three motor tasks (Po0.01). In addition, patients' impressions of change were greater than clinicians' impressions of change for transferring, but comparable for unsupported sitting and walking. Conclusion: Clinicians' and patients' impressions of change in motor performance may have potential for evaluating treatment effectiveness in clinical trials.

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“…Participants will be required to rate their perceptions about changes in hand function on a 15-point scale where zero indicates no change, +7 indicates "a very great deal better" and -7 indicates "a very great deal worse" [31]. …”

Section: Methodsmentioning

confidence: 99%

Early intensive hand rehabilitation after spinal cord injury ("Hands On"): a protocol for a randomised controlled trial

Harvey

Dunlop

Чурилов

et al. 2011

Trials

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BackgroundLoss of hand function is one of the most devastating consequences of spinal cord injury. Intensive hand training provided on an instrumented exercise workstation in conjunction with functional electrical stimulation may enhance neural recovery and hand function. The aim of this trial is to compare usual care with an 8-week program of intensive hand training and functional electrical stimulation.Methods/designA multicentre randomised controlled trial will be undertaken. Seventy-eight participants with recent tetraplegia (C2 to T1 motor complete or incomplete) undergoing inpatient rehabilitation will be recruited from seven spinal cord injury units in Australia and New Zealand and will be randomised to a control or experimental group. Control participants will receive usual care. Experimental participants will receive usual care and an 8-week program of intensive unilateral hand training using an instrumented exercise workstation and functional electrical stimulation. Participants will drive the functional electrical stimulation of their target hands via a behind-the-ear bluetooth device, which is sensitive to tooth clicks. The bluetooth device will enable the use of various manipulanda to practice functional activities embedded within computer-based games and activities. Training will be provided for one hour, 5 days per week, during the 8-week intervention period. The primary outcome is the Action Research Arm Test. Secondary outcomes include measurements of strength, sensation, function, quality of life and cost effectiveness. All outcomes will be taken at baseline, 8 weeks, 6 months and 12 months by assessors blinded to group allocation. Recruitment commenced in December 2009.DiscussionThe results of this trial will determine the effectiveness of an 8-week program of intensive hand training with functional electrical stimulation.Trial registrationNCT01086930 (12th March 2010)ACTRN12609000695202 (12th August 2009)

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Sufficiently Important Difference: Expanding the Framework of Clinical Significance

Cited by 160 publications

References 70 publications

Effects of 6 months of regular passive movements on ankle joint mobility in people with spinal cord injury: a randomized controlled trial

Effects of 6 months of regular passive movements on ankle joint mobility in people with spinal cord injury: a randomized controlled trial

Clinicians’ and patients’ impressions of change in motor performance as potential outcome measures for clinical trials

Early intensive hand rehabilitation after spinal cord injury ("Hands On"): a protocol for a randomised controlled trial

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