Reporting improvement from patient-reported outcome measures: A review

Houweling, Taco A.W.

doi:10.1016/j.clch.2009.12.003

Cited by 15 publications

(6 citation statements)

References 66 publications

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“…Finally, inaccuracies related to the cut-off points could be attenuated if the classifications obtained by applying the distribution-based methods could be supplemented by the information provided by the anchor-based methods (see Barrett, Brown, & Mood, 2008; de Vet & Terwee, 2010; Houweling, 2010; Turner et al, 2010), or the cumulative proportion of responders (Farrar, Dworkin, & Max, 2006; McLeod, Coon, Martin, Fhenel, & Hays, 2011; Wyrwich et al, 2013), but it is still necessary to research this point further. There is also a need to further investigate the appropriateness of using specific cut-off points for each specific context or for each type of disorder (Button et al, 2015; Lemieux, Beaton, Hogg-Johnson, Bordeleau, & Goodwin, 2007; McGlothlin & Lewis, 2014; Revicki et al, 2008; Terwee et al, 2010).…”

Section: Discussionmentioning

confidence: 99%

Clinically Meaningful Change

Ferrer-Urbina

Pardo

2019

Methodology

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Abstract. In a recent paper, Ferrer and Pardo (2014) tested several distribution-based methods designed to assess when test scores obtained before and after an intervention reflect a statistically reliable change. However, we still do not know how these methods perform from the point of view of false negatives. For this purpose, we have simulated change scenarios (different effect sizes in a pre-post-test design) with distributions of different shapes and with different sample sizes. For each simulated scenario, we generated 1,000 samples. In each sample, we recorded the false-negative rate of the five distribution-based methods with the best performance from the point of view of the false positives. Our results have revealed unacceptable rates of false negatives even with effects of very large size, starting from 31.8% in an optimistic scenario (effect size of 2.0 and a normal distribution) to 99.9% in the worst scenario (effect size of 0.2 and a highly skewed distribution). Therefore, our results suggest that the widely used distribution-based methods must be applied with caution in a clinical context, because they need huge effect sizes to detect a true change. However, we made some considerations regarding the effect size and the cut-off points commonly used which allow us to be more precise in our estimates.

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Section: Discussionmentioning

confidence: 99%

Clinically Meaningful Change

Ferrer-Urbina

Pardo

2019

Methodology

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“…External responsiveness is the extent to which changes in a measure over a specified time frame are associated with corresponding changes in a reference measure [19]. This reference measure can either be a global rating of perceived change [20][21][22] or a measurement tool assessing a similar construct [23,24]. In this study, the association between change scores obtained from the repeated administrations of the ULFI-FC and DASH-FC were examined.…”

Section: Study Design/data Collectionmentioning

confidence: 99%

Test–retest reliability and responsiveness of a French Canadian Upper Limb Functional Index (ULFI-FC)

Hamasaki

Demers

Filiatrault

2014

Disability and Rehabilitation

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The ULFI-FC is a reliable and valid tool with good responsiveness to change for assessing activity limitations and participation restrictions in adults presenting with upper limb musculoskeletal disorders. This tool can thus be useful in clinical and research settings. By exploring meaningful activities that are affected by patients' upper limb musculoskeletal disorders, the tool's Patient Specific Index is particularly relevant for clinicians adhering to a patient-centered approach.

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“…However, reliability in the form of internal consistency and test-retest reliability is difficult to determine for global impression of change scales as internal consistency relates individual items of a questionnaire to the total score (global scales are composed of a single question), and test-retest reliability would require subjects to rate global change twice for the same problem with the same period of improvement. Construct validity may be supported by looking at the relationship between physical outcomes and patient-reported outcomes [ 60 ].…”

Section: Methodsmentioning

confidence: 99%

“…It uses 11-point numerical rating scales for pain, functional and social activity, depression, anxiety, coping ability and fear avoidance behaviours. The instrument has been shown to be reliable, valid, responsive to change and able to detect and quantify clinically significant improvement [ 25 , 60 - 63 ]. All measurements were treated as continuous variables and analysed for differences between and within the groups using the total raw score.…”

Section: Methodsmentioning

confidence: 99%

Relative effectiveness and adverse effects of cervical manipulation, mobilisation and the activator instrument in patients with sub-acute non-specific neck pain: results from a stopped randomised trial

Gemmell

Miller

2010

Chiropr Man Therap

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BackgroundNeck pain of a mechanical nature is a common complaint seen by practitioners of manual medicine, who use a multitude of methods to treat the condition. It is not known, however, if any of these methods are superior in treatment effectiveness. This trial was stopped due to poor recruitment. The purposes of this report are (1) to describe the trial protocol, (2) to report on the data obtained from subjects who completed the study, (3) to discuss the problems we encountered in conducting this study.MethodsA pragmatic randomised clinical trial was undertaken. Patients who met eligibility criteria were randomised into three groups. One group was treated using specific segmental high velocity low amplitude manipulation (diversified), another by specific segmental mobilisation, and a third group by the Activator instrument. All three groups were also treated for any myofascial distortions and given appropriate exercises and advice. Participants were treated six times over a three-week period or until they reported being pain free. The primary outcome measure for the study was Patient Global Impression of Change (PGIC); secondary outcome measures included the Short-Form Health Survey (SF-36v2), the neck Bournemouth Questionnaire, and the numerical rating scale for pain intensity. Participants also kept a diary of any pain medication taken and noted any perceived adverse effects of treatment. Outcomes were measured at four points: end of treatment, and 3, 6, and 12 months thereafter.ResultsBetween January 2007 and March 2008, 123 patients were assessed for eligibility, of these 47 were considered eligible, of which 16 were allocated to manipulation, 16 to the Activator instrument and 15 to the mobilisation group. Comparison between the groups on the PGIC adjusted for baseline covariants did not show a significant difference for any of the endpoints. Within group analyses for change from baseline to the 12-month follow up for secondary outcomes were significant for all groups on the Bournemouth Questionnaire and for pain, while the mobilisation group had a significant improvement on the PCS and MCS subscales of the SF-36v2. Finally, there were no moderate, severe, or long-lasting adverse effects reported by any participant in any group.ConclusionsAlthough the small sample size must be taken into consideration, it appears that all three methods of treating mechanical neck pain had a long-term benefit for subacute neck pain, without moderate or serious adverse events associated with any of the treatment methods. There were difficulties in recruiting subjects to this trial. This pragmatic trial should be repeated with a larger sample size.

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Reporting improvement from patient-reported outcome measures: A review

Cited by 15 publications

References 66 publications

Clinically Meaningful Change

Clinically Meaningful Change

Test–retest reliability and responsiveness of a French Canadian Upper Limb Functional Index (ULFI-FC)

Relative effectiveness and adverse effects of cervical manipulation, mobilisation and the activator instrument in patients with sub-acute non-specific neck pain: results from a stopped randomised trial

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