Validation of a visual analog scale for assessing cough severity in patients with chronic cough
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ABSTRACT: Introduction:
Patients with chronic cough experience considerable burden. The cough
SUBMITTER: Martin Nguyen A
PROVIDER: S-EPMC8552382 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:AimsThe Cough Severity Diary (CSD) was developed in accordance with the FDA guidance for patient-reported outcome measures and is focused on capturing the patient's perception of cough in terms of frequency, intensity, and disruption due to their cough. The measure includes a series of seven items asking patients to rate the frequency (three items), intensity (two items), and disruptiveness (two items) of their cough. The instrument was designed to be completed daily before bedtime, has a recall period of 'today,' and responses to items are entered on an 11-point numeric rating scale ranging from 0 to 10 with anchors on each end. The objective of this analysis was to confirm the domain structure of the CSD and assess its reliability, validity, and responsiveness in adult patients with refractory or unexplained chronic cough (RCC/UCC). Criteria for defining meaningful changes in mean weekly CSD total and domain scores in the context of a clinical trial were also developed.MethodsPooled data from a phase II randomized controlled trial of an investigational treatment for RCC/UCC were analyzed. Participants were non-smokers, had RCC/UCC for ⩾1 year, and a baseline cough severity visual analogue scale (VAS) ⩾40 mm. CSD scores (baseline, week 4), were analyzed; the Leicester Cough Questionnaire (LCQ), cough severity VAS, Patient Global Impression of Change (PGIC), and objective cough frequency counts were used for validation. CSD domain structure (Total, Frequency, Intensity, Disruption) was assessed for scoring.ResultsA total of 253 participants were included (mean age 60.2; 76% female). Global fit of the three-factor CSD was acceptable. For the CSD total score, internal consistency (α = 0.89) and test-retest reliability (intraclass correlation coefficient = 0.68) were high. CSD total scores were correlated with the LCQ total (r = -0.62) and cough severity VAS (r = 0.84). Participants with a PGIC score of 1 or 2 (most improved groups) had the greatest mean score improvement on the CSD Total (Day 0 to Day 28), supporting responsiveness (similar findings for subscales). A change threshold of ⩾1.3-point reduction on the total and subscale scores is appropriate to define clinically meaningful improvement.ConclusionThe CSD is a reliable, valid, and responsive measure of cough symptom severity in patients with refractory or unexplained chronic cough and fit-for-purpose for assessing changes in cough severity in clinical trials. The reviews of this paper are available via the supplemental material section.
| S-EPMC7225816 | biostudies-literature
Project description:BackgroundRefractory chronic cough (RCC), a cough lasting longer than 8 weeks with an unexplained underlying etiology and unresponsive to conventional treatment, can have substantial effects on patients' quality of life. For assessment of the efficacy of antitussive medication in clinical trials in RCC, patient-reported outcome (PRO) instruments should be fit for purpose with appropriate content validity. Here we describe the qualitative testing of a newly developed PRO instrument: the Severity of Chronic Cough Diary (SCCD).MethodsThe SCCD was developed to assess patients' symptom experience of cough in patients with RCC. A preliminary version was tested and refined based on an iterative process in a qualitative study. In total, three rounds of interviews were conducted with adult participants diagnosed with RCC in the USA (n = 19) and UK (n = 10). Rounds 1-3 consisted of hybrid concept elicitation (CE) interviews and cognitive interviews (CIs), with Round 3 also including interviews in a subset of participants (n = 5) about the usability of the SCCD as administered on an electronic handheld device.ResultsThe CE interviews identified concepts important to patients' experiences related to RCC that were broadly in line with the concepts in the preliminary version of the SCCD. Participants provided positive feedback on the draft SCCD across all CI rounds, reporting the instrument to be relevant and straightforward to complete, and containing a comprehensive set of concepts to evaluate their symptom experience of RCC. Participants demonstrated a good understanding of proposed item wording, response options, and the 24-hour recall period, and thought completion of the SCCD on the electronic device was easy. Following revisions based on results from each interview round, the SCCD at the end of this qualitative research study had 14 items assessing the concepts of: cough symptoms (five items), symptoms related to cough (four items), disruption to activities due to cough (three items), and disruption to sleep due to cough (two items).ConclusionsThe results of this study provide qualitative evidence supporting the content validity of the SCCD as a PRO instrument for evaluating outcomes of therapies for RCC in clinical trials.
| S-EPMC10333155 | biostudies-literature
Project description:Interpersonal theory organizes social behavior along dominant (vs. submissive) and warm (vs. cold) dimensions. There is a growing interest in assessing these behaviors in naturalistic settings to maximize ecological validity and to study dynamic social processes. Studies that have assessed interpersonal behavior in daily life have primarily relied on behavioral checklists. Although checklists have advantages, they are discrepant with techniques used to capture constructs typically assessed alongside warmth and dominance, such as affect, which typically rely on adjective descriptors. Further, these checklists are distinct from the methodologies used at the dispositional level, such as personality inventories, which rarely rely on behavioral checklists. The present study evaluates the psychometric performance of interpersonal adjectives presented on a visual analog scale in five different samples. Validity of the Visual Interpersonal Analog scale (VIAS) approach to momentary assessment was evaluated by comparing its performance with an interpersonal behavior checklist and by examining associations among the VIAS Warmth and Dominance scales and other momentary and dispositional constructs. Results were generally consistent with an existing interpersonal behavior checklist at the within-person level but diverged somewhat at the dispositional level. Across the five samples, the VIAS generally performed as hypothesized at both the within- and between-person levels. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
| S-EPMC10107404 | biostudies-literature
Project description:Background In clinical audits in which preoperative visual analog scale (VAS) scores were not recorded, it would be useful if such scores could be re-created at the time of review. Patients and Methods We recorded VAS score for pain during the past week before surgery for 245 consecutive hand-surgery patients scheduled for planned surgery during a 6-month period. A total of 30 patients who refused to participate or were unable to respond were excluded. The remaining 215 patients were contacted after 21 months and asked to furnish a new VAS score of the pain they remembered to have had during the last week before surgery. Responses were analyzed with a Bland-Altman plot. Results One hundred and thirty-one (61%) of the patients responded. The mean remembered preoperative score was higher than the mean real preoperative score in all diagnosis groups. The mean difference was 10 mm (standard deviation: 22 mm; standard error of the mean: 2 mm). The lower and upper limits of 95% agreement for individual scores were -33 and 53 mm, whereas the lower and upper limits of the 95% confidence interval of the mean were 6 and 14 mm. Conclusion It may be possible to predict the mean real preoperative VAS score in groups of patients with accuracy using the remembered preoperative score. In individual patients, remembered preoperative VAS scores are far too inaccurate to be of value. However, real preoperative scores should be used whenever possible.
| S-EPMC7141901 | biostudies-literature
Project description:BACKGROUND:Accurate measurement of pain is required to improve its management and in research. The visual analog scale (VAS) on paper format has been shown to be an accurate, valid, reliable, and reproducible way to measure pain intensity. However, some limitations should be considered, some of which can be implemented with the introduction of an electronic VAS version, suitable to be used both in a tablet and a smartphone. OBJECTIVE:This study aimed to validate a new method of recording pain level by comparing the traditional paper VAS with the pain level module on the newly designed Interactive Clinics app. METHODS:A prospective observational cross-sectional study was designed. The sample consisted of 102 participants aged 18 to 65 years. A Force Dial FDK 20 algometer (Wagner Instruments) was employed to induce mild pressure symptoms on the participants' thumbs. Pain was measured using a paper VAS (10 cm line) and the app. RESULTS:Intermethod reliability estimated by ICC(3,1) was 0.86 with a 95% confidence interval of 0.81 to 0.90, indicating good reliability. Intramethod reliability estimated by ICCa(3,1) was 0.86 with a 95% confidence interval of 0.81 to 0.90, also indicating good reliability. Bland-Altman analysis showed a difference of 0.175 (0.49), and limits of agreement ranged from -0.79 to 1.14. CONCLUSIONS:The pain level module on the app is highly reliable and interchangeable with the paper VAS version. This tool could potentially help clinicians and researchers precisely assess pain in a simple, economic way with the use of a ubiquitous technology.
| S-EPMC7055746 | biostudies-literature
Project description:Background: Deep brain stimulation (DBS) has become a standard treatment for advanced stages of Parkinson's disease, essential tremor, and dystonia. In addition to the correct surgical device implantation, effective programming is regarded to be the most important factor for clinical outcome. Despite established strategies for adjusting neurostimulation, DBS programming remains time- and resource-consuming. Although kinematic and neuronal biosignals have recently been examined as potential feedback for closed-loop DBS (CL-DBS), there is an ongoing need for programming strategies to adapt the stimulation parameters and electrode configurations accurately and effectively. Methods: Here, we tested the usefulness of a patient-rated visual analog scale (VAS) for real-time adjustment of DBS parameters. The stimulation parameters (contact and amplitude) in Parkinson's patients with STN-DBS (n = 17) were optimized based on the patient's subjective VAS rating. A Minkowski distance (Md) was calculated to compare the individual combination of contact selection and amplitude to the stimulation parameters that resulted from classical programming based on clinical signs and symptoms. Results: We found no statistically significant difference between VAS-based and classical programming in regard to the specific contact or amplitude used or in regard to the clinical disease severity (UPDRS). Conclusions: Our data suggest that VAS-based and classical programming strategies both lead to similar short-term results. Although further research will be required to assess the validity of VAS-based DBS programming, our results support the investigation of the patient's subjective rating as an additional and valid feedback signal for individualized DBS adjustment.
| S-EPMC7661931 | biostudies-literature
Project description:OBJECTIVES:To evaluate the possible value of the perfusion index (PI) as a tool for pain assessment. Methods: This prospective, observational study was performed with 89 patients underwent surgery with general anesthesia. The patients with visual analog scale (VAS) greater than 3 were grouped as M1, and patients with VAS?3 and performed morphine were grouped as M2. After surgery patients with VAS greater than 3 were given 2mg morphine. Patients with VAS greater than 3 were given increments of intravenous morphine (2 mg) at 20 minute intervals until VAS less than 3. The correlation and difference between PI and VAS score values were evaluated before and after analgesic administration. Results: Significant changes were found in both PI values and VAS scores between M1 and M2 groups (2.80±0.77, 3.97±0.94, p less than 0.001; 6.60±1.20, 2.74±0.46, p less than 0.001) Despite no correlation was found between PI values and VAS scores of M1 and M2 groups, weak negative correlation was detected between differences in PI values and VAS scores among groups (r=-0.255, p=0.016). Conclusion: Perfusion index is a parameter that can be used in the assessment of postoperative pain and responses to analgesics.
| S-EPMC6201022 | biostudies-literature
Project description:BackgroundLivedoid vasculopathy is an orphan skin disease characterized by recurrent thrombosis of the cutaneous microcirculation. It manifests itself almost exclusively in the ankles, the back of the feet, and the distal part of the lower legs. Because of the vascular occlusion, patients suffer from intense local ischemic pain. Incidence of livedoid vasculopathy is estimated to be around 1:100,000. There are currently no approved treatments for livedoid vasculopathy, making off-label therapy the only option. In Europe, thromboprophylactic treatment with low-molecular-weight heparins has become widely accepted.ObjectiveThe aim of this trial is the statistical verification of the therapeutic effects of the anticoagulant rivaroxaban in patients suffering from livedoid vasculopathy.MethodsWe performed a therapeutic phase IIa trial designed as a prospective, one-armed, multicenter, interventional series of cases with a calculated sample size of 20 patients. The primary outcome is the assessment of local pain on the visual analog scale (VAS) as an intraindividual difference of 2 values between baseline and 12 weeks.ResultsEnrollment started in December 2012 and was still open at the date of submission. The study is expected to finish in November 2014.ConclusionsLivedoid vasculopathy is associated with increased thrombophilia in the cutaneous microcirculation and the continuous use of anticoagulants helps improve the symptoms. The causes of cutaneous infarctions are heterogenous, but ultimately follow the known mechanisms of the coagulation cascade. Rivaroxaban affects the coagulation cascade and inhibits the factor Xa-dependent conversion of prothrombin to thrombin, thereby considerably reducing the risk of thrombosis.Trial registrationTrial Registration EudraCT Number: 2012-000108-13-DE; https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000108-13 (Archived by WebCite at http://www.webcitation.org/6UCktWVCA); German Clinical Trials Register (DRKS): DRKS00004652; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004652 (Archived by WebCite at http://www.webcitation.org/6UCIAKyCS).
| S-EPMC4275467 | biostudies-literature
Project description:OBJECTIVES:To develop and test the psychometric properties of an Arabic version of Fatigue Severity Scale (FSS-Ar) that can be used to measure fatigue in Arabic patients with disorders where fatigue is a major symptom. METHODS:Forward and backward translations of FSS were undertaken to develop an Arabic version. The validity and reliability of the FSS-Ar was then tested on 28 patients with systemic lupus erythematosus (SLE), 24 patients with multiple sclerosis (MS), and 31 healthy subjects. Exploratory factor analysis and hypothesis testing methods were used to examine construct validity. The correlation between FSS-Ar and the vitality domain of the RAND 36-Item Health was examined to test construct validity. The study was conducted at the King Khalid University Hospital, Riyadh, Kingdom of Saudi Arabia between February and June 2012. RESULTS:Using a score of ?4.05 to define fatigue, 39 of 52 (75%) participants were fatigued compared with 10 out of 31 (32%) healthy participants. The correlation between the FSS-Ar and the vitality domain of the RAND-36 was acceptable (r = -0.46). Factor analysis showed that items of the FSS-Ar measured one underlying construct, namely, fatigue. Test-retest reliability and internal consistency of the FSS-Ar was acceptable (intraclass correlation coefficient model 2,1 = 0.80; Cronbach's alpha = 0.84). CONCLUSION:The Arabic version of the FSS demonstrated acceptable psychometric properties and was able to differentiate between patients with SLE or MS, and healthy subjects.
| S-EPMC4724683 | biostudies-other
Project description:BACKGROUND:To quantify pain severity in patients and the efficacy treatments, researchers and clinicians apply tools such as the traditional visual analog scale (VAS) that leads to inaccurate interpretation of the main sensory pain. OBJECTIVE:This study aimed to validate the pain measurements of a neuroscience-based 3D body pain mobile app called GeoPain. METHODS:Patients with temporomandibular disorder (TMD) were assessed using GeoPain measures in comparison to VAS and positive and negative affect schedule (PANAS), pain and mood scales, respectively. Principal component analysis (PCA), scatter score analysis, Pearson methods, and effect size were used to determine the correlation between GeoPain and VAS measures. RESULTS:The PCA resulted in two main orthogonal components: first principal component (PC1) and second principal component (PC2). PC1 comprises a combination score of all GeoPain measures, which had a high internal consistency and clustered together in TMD pain. PC2 included VAS and PANAS. All loading coefficients for GeoPain measures in PC1 were above 0.70, with low loadings for VAS and PANAS. Meanwhile, PC2 was dominated by a VAS and PANAS coefficient >0.4. Repeated measure analysis revealed a strong correlation between the VAS and mood scores from PANAS over time, which might be related to the subjectivity of the VAS measure, whereas sensory-discriminative GeoPain measures, not VAS, demonstrated an association between chronicity and TMD pain in locations spread away from the most commonly reported area or pain epicenter (P=.01). Analysis using VAS did not detect an association at baseline between TMD and chronic pain. The long-term reliability (lag >1 day) was consistently high for the pain area and intensity number summation (PAINS) with lag autocorrelations averaging between 0.7 and 0.8, and greater than the autocorrelations for VAS averaging between 0.3 and 0.6. The combination of higher reliability for PAINS and its objectivity, displayed by the lack of association with PANAS as compared with VAS, indicated that PAINS has better sensitivity and reliability for measuring treatment effect over time for sensory-discriminative pain. The effect sizes for PAINS were larger than those for VAS, consequently requiring smaller sample sizes to assess the analgesic efficacy of treatment if PAINS was used versus VAS. The PAINS effect size was 0.51 SD for both facial sides and 0.60 SD for the right side versus 0.35 SD for VAS. Therefore, the sample size required to detect such effect sizes with 80% power would be n=125 per group for VAS, but as low as n=44 per group for PAINS, which is almost a third of the sample size needed by VAS. CONCLUSIONS:GeoPain demonstrates precision and reliability as a 3D mobile interface for measuring and analyzing sensory-discriminative aspects of subregional pain in terms of its severity and response to treatment, without being influenced by mood variations from patients.
| S-EPMC7468641 | biostudies-literature