Assessing the Quality of Available Patient Reported Outcome Measures for Intermittent Claudication: A Systematic Review Using the COSMIN Checklist

Conijn, A.P.; Jens, Sjoerd; Terwee, Caroline B.; Breek, J.C.; Koelemay, M.J.W.

doi:10.1016/j.ejvs.2014.12.002

Cited by 50 publications

(58 citation statements)

References 52 publications

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“…Subsequently, most of the studies were rated low in terms of quality. Another systematic review of PROMs in patients with IC found that the methodological quality of most studies ranged from poor to fair [35]. Our review supports the findings of the review by Conijn et al [35] confirming the need for better quality studies of PROMs.…”

Section: Discussionsupporting

confidence: 87%

Patient-reported outcome measures in patients with peripheral arterial disease: a systematic review of psychometric properties

Poku

Duncan

Keetharuth

et al. 2016

Health Qual Life Outcomes

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BackgroundPeripheral arterial disease (PAD) is generally associated with considerable morbidity and reduced quality of life. Patient-reported outcome measures (PROMs) provide important information about the burden of disease and impact of treatment in affected patients.ObjectivesThe objective of the review was to identify and appraise studies reporting the psychometric evaluation of PROMs administered to a specified population of patients with PAD with a view to recommending suitable PROMs.MethodsA systematic review of peer-reviewed English language articles was undertaken to identify primary studies reporting psychometric properties of PROMs in English-speaking patients with various stages of PAD. Comprehensive searches were completed up until January 2015. Study selection, data extraction and quality assessment were undertaken independently by at least two researchers. Findings were presented as tabular and narrative summaries based on accepted guidance.ResultsPsychometric evaluation of 6 generic and 7 condition-specific PROMs reported in 14 studies contributed data to the review. The frequently reported measure was the SF-36 (n = 11 studies); others included the Walking Impairment Questionnaire (n = 8 studies), EQ-5D (n = 5 studies) and the Vascular Quality of Life Questionnaire (n = 3 studies). Studies included a diverse PAD population and varied in methodology, including approach to validation of PROMs.ConclusionsVarious PROMs have been validated in patients with PAD but no study provided evidence of a full psychometric evaluation in the patient population. Careful selection is required to identify reliable and valid PROMs to use in clinical and research settings.Electronic supplementary materialThe online version of this article (doi:10.1186/s12955-016-0563-y) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 87%

Patient-reported outcome measures in patients with peripheral arterial disease: a systematic review of psychometric properties

Poku

Duncan

Keetharuth

et al. 2016

Health Qual Life Outcomes

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“…This is a well validated measure using 5 sub-scales: Social Relationships, Self-Concepts and Feelings, Symptoms and Limitations in Physical Functioning, Fear and Uncertainty, and Positive Adaptation. 31 …”

Section: Methodsmentioning

confidence: 99%

Functional electrical stimulation improves quality of life by reducing intermittent claudication

Embrey

Alon

Brandsma

et al. 2017

International Journal of Cardiology

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Objective To determine if Functional Electrical Stimulation (FES) would improve ischemic pain, walking distance, and quality of life of patients with intermittent claudication. Design Single blind, randomized block, two factorial design. Patients Patients diagnosed with Peripheral Artery Disease (PAD) and intermittent claudication (IC). Ankle Brachial Index ranged 0.4–0.9 on at least one leg. Patients were randomly assigned to experimental (FES+Walk, N=13) or control (WALK, N=14) groups. Intervention Experimental group patients received FES to the dorsiflexor and plantarflexor muscles while walking for one hour/day, six days/week for eight weeks. Control group patients received similar intervention without FES. A Follow-up period of both groups lasted eight weeks. Outcome Measures Outcome measures were taken at baseline (T0), after intervention (T1), and after follow-up (T2). Primary measures included Perceived Pain Intensity (PPI), Six Minute Walk (6MW), and Peripheral Arterial Disease Quality of Life (PADQOL). Secondary measures included Intermittent Claudication Questionnaire (ICQ) and Timed Up and Go (TUG). Results Group by time interactions in PPI were significant (P<.001) with differences of 27.9 points at T1 and 36.9 points at T2 favoring the FES+Walk group. Groups difference in Symptoms and Limitations in Physical Function of the PADQOL reached significance (T1=8.9, and T2=8.3 improvements; P=.007). ICQ was significant (T1=9.3 and T2=13.1 improvements; P=.003). Improvement in 6MW and TUG tests were similar between groups. Conclusions and Relevance Walking with FES markedly reduced ischemic pain and enhanced QOL compared to just walking. FES while walking may offer an effective treatment option for the elderly with PAD and Intermittent Claudication.

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“…Improvement of 11.5 points and 13.7 points on the PADQOL-symptom and limitation in physical functioning (factor 3) and ICQ scales respectively, appear 2.2 and 4.7 times greater than when these patients were part of the WALK only group of the original study [17]. These data should remove doubts about the fidelity of FES contribution to improving quality of life measures for patients with PAD and IC [20,23]. In the original study we reported that the 4 other factors of the PADQOL questionnaire (Social Relationships, Self-Concepts and Feelings, Fear and Uncertainty, and Positive Adaptation) did not change significantly over time in either the FES+Walk or Walk groups.…”

Section: Discussionmentioning

confidence: 86%

“…In the original study we reported that the 4 other factors of the PADQOL questionnaire (Social Relationships, Self-Concepts and Feelings, Fear and Uncertainty, and Positive Adaptation) did not change significantly over time in either the FES+Walk or Walk groups. It is conceivable that these factors of the PAD quality of life questionnaire might be appropriate health-related quality of life measures, but do not reflect or interrelate to walking impairment or functional status of PAD patients who are able to ambulate in the home environment [20].…”

Section: Discussionmentioning

confidence: 99%

“…4) The Intermittent Claudication Questionnaire (ICQ) measured the impact of walking pain on quality of life. This measure has been shown to be a reliable and valid measure of quality of life for patients with IC [20]. 5) The Timed Up and Go (TUG) measured the time (sec) needed for patients to stand up from a standard chair, walk 3 meters, walk around a cone, return to the chair, and sit down.…”

Section: Outcome Measuresmentioning

confidence: 99%

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Functional Electrical Stimulation (FES) Reduces Intermittent Claudication (IC) and Improves Quality of Life (QOL) Measures: A Cohort Crossover

Alon¹

2017

Phys Med Rehabil Int

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Aim: This crossover investigation applied functional electrical stimulation (FES) to the dorsiflexors (DF) and plantarflexors (PF) during walking in the home environment, hypothesizing that it will reduce intermittent claudication (IC), improve walking distance, and enhance quality of life measures compared to three baseline data points during which FES was not provided. Methods:Nine male patients, 68.4±4 yrs old, and ankle-brachial index between 0.4-0.8 who completed 16 weeks walking 1hr, 6 days/week without FES consented to walk the same amount wearing FES applied bilaterally to the DF and PF. Measurements of perceived pain intensity (PPI) at the end of a 6min walk test (6MW), walking distance, peripheral arterial disease quality of life (PADQOL), intermittent claudication questionnaire (ICQ) and timed up and go (TUG) were obtained at baseline (T0), after 8 weeks walking without FES (T1), after 8 weeks follow up (T2) and after 8 weeks walking with FES (T3). Repeated ANOVA was used to analyze the data and significance was assessed at the P<.05 level.Results: PPI at T0 was 51.3±19.4 and significantly dropped to 9.9±11.1 (p<.001) at T3 registering a large effect size (Ƞ2=.42), PADQOL factor 3 improved by 14.8 points between T0 and T3 (p=.01; Ƞ2=.36) and ICQ score improved by 16.3 points (p=.004; Ƞ2=.36). The 6MW distance and TUG did not change during the study. Conclusion:This crossover study added validity to the hypothesis that applying FES while walking can markedly diminish the intermittent claudication pain and improve quality of life measures in community ambulatory patients with PAD and IC.

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Assessing the Quality of Available Patient Reported Outcome Measures for Intermittent Claudication: A Systematic Review Using the COSMIN Checklist

Cited by 50 publications

References 52 publications

Patient-reported outcome measures in patients with peripheral arterial disease: a systematic review of psychometric properties

Patient-reported outcome measures in patients with peripheral arterial disease: a systematic review of psychometric properties

Functional electrical stimulation improves quality of life by reducing intermittent claudication

Functional Electrical Stimulation (FES) Reduces Intermittent Claudication (IC) and Improves Quality of Life (QOL) Measures: A Cohort Crossover

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