scholarly journals Construct validity and internal consistency of the Breast Inflammatory Symptom Severity Index in lactating mothers with inflammatory breast conditions

PeerJ ◽  
2021 ◽  
Vol 9 ◽  
pp. e12439
Author(s):  
Emma Heron ◽  
Adelle McArdle ◽  
Md Nazmul Karim ◽  
Melinda Cooper ◽  
Donna Geddes ◽  
...  

Background Inflammatory Conditions of the Lactating Breast (ICLB) affect more than one in five lactating mothers, yet no fully validated outcome measures exist to aid clinicians in their patient-centred care of women with ICLB. The Breast Inflammatory Symptom Severity Index (BISSI) is an ICLB-specific clinician administered patient-reported outcome measure, currently used by Australian clinicians, who treat mothers with ICLB. To date the BISSI has undergone partial psychometric development. This study, therefore, aimed to undertake the next stage of psychometric development by determining the construct validity and internal consistency of the BISSI. Methods A retrospective audit was conducted on patient records of 160 mothers who were treated for ICLB, at a private physiotherapy practice in Melbourne, Australia. An electronic data capture tool was used to collate BISSI scores and associated ICLB assessment variables. Construct validity was determined through factor analysis and discriminant performance. Reliability was determined by assessing measures of internal consistency. Results Factor analysis established that BISSI items (n = 10) loaded on to four factors, Wellness, Pain, Physical Characteristics of Affected Area (PCAA), and Inflammation, which together, explained 71.2% of variance. The remaining item (‘Wellness/sickness unspecified’) did not load. Wellness, Pain, PCAA and Inflammation factors individually and collectively displayed the ability to discriminate symptom severity, as scores were significantly higher in mothers with high symptom severity (assessed via AUC close to or >0.7 and P value <0.005 for each factor). The BISSI demonstrated internal consistency with an overall Cronbach alpha of 0.742. Conclusions The BISSI has adequate construct validity, demonstrating behaviour consistent with theoretical constructs of inflammation severity, via its dimensionality and ability to discriminate symptom severity. The BISSI also has adequate internal consistency demonstrating reliability. Therefore, clinicians can have confidence that the BISSI is valid, the individual item scores are correlated, and the concepts are consistently measured.

2020 ◽  
pp. 2003156
Author(s):  
Megan L. Crichton ◽  
Emily K. Dudgeon ◽  
Amelia Shoemark ◽  
James D. Chalmers

IntroductionExisting quality of life and symptom tools used in bronchiectasis trials are either not disease specific or are complex and have not been consistently responsive. We developed a simple patient reported visual analogue outcome measure, the bronchiectasis impact measure (BIM) for use in clinical research including clinical trials.MethodsPatients with bronchiectasis attending a tertiary referral clinic in the East of Scotland were invited to complete the BIM questionnaire and the Quality of life bronchiectasis questionnaire at baseline with repeat questionnaires after 2 weeks and 6 months. We assessed internal consistency, test-retest reliability, construct validity and responsiveness by evaluating change during an acute exacerbation.Results173 patients were included. The 8 domains (Cough, sputum, breathlessness, tiredness, activity, general health, control, exacerbations) showed excellent internal consistency (Cronbach α 0.93). The intraclass correlation coefficient (ICC) demonstrated excellent reliability over a 2-week period, cough (0.79 (95%CI 0.70–0.85)), sputum (0.86 (95%CI 0.80–0.90)), dyspnoea (0.82 (95%CI 0.74–0.87)), tiredness (0.88 (95%CI 0.82–0.91)), activity (0.84 (95%CI 0.77–0.89)), general health (0.81 (95%CI 0.74–0.87)), control (0.83 (95%CI (0.75–0.88)) and exacerbation (0.71 (95%CI (0.60–0.79)). Domains correlated strongly with bronchiectasis severity and exacerbation history. Both distribution and patient-based methods estimated the MCID for each domain as 1.5 points on a 10-point scale. Statistically significant changes in all BIM domains were observed during an acute exacerbation.ConclusionThe BIM is a simple patient reported outcome. This study validates the internal consistency, reliability, construct validity and response of the tool at acute exacerbation. Further validation of the tool is now required.


2020 ◽  
pp. 174749302097936
Author(s):  
V Prakash ◽  
Mohan Ganesan

Background Prospects of a participation measure to be valid across cultures are debatable. Existing stroke outcome measures had been shown to have limited validity when used within Indian sociocultural contexts. Aim To develop and validate a patient-reported outcome measure of participation in daily activities appropriate for patients with stroke living in an Indian sociocultural context. Methods The scale was developed in two phases: scale development and psychometric testing. Items were derived from a conceptual framework of participation in daily activities of patients who had experienced stroke within an Indian context. The final version of the scale consisted of 25 items. A total of 377 patients diagnosed with stroke were recruited from two tertiary care hospitals and five physiotherapy outpatient rehabilitation centers in India. Psychometric testing of the scale included investigation of internal consistency, unidimensionality, construct validity (known group and convergent validity), and test–retest reliability. Results The scale items demonstrated good internal consistency (Cronbach’s alpha = .94). Confirmatory factor analysis results showed acceptable goodness of fit. The scale has shown good construct validity and test–retest reliability (intraclass correlation coefficient = 0.80). The scale differentiated patients with low and high disability severity (mean difference = 34, 95% CI = 27 to 39) and moderately associated with physical and instrumental activities of daily living ( r = 0.64, p < .001) and social participation domains of stroke impact scale ( r = 0.44, p < .001) and Barthel index ( r = 0.59, p < .001). Conclusion The Indian Stroke Scale has shown preliminary evidence of validity to support its use as a patient-reported outcome measure for evaluating poststroke participation in daily activities among patients with stroke in India.


2017 ◽  
Vol 76 (8) ◽  
pp. 1374-1380 ◽  
Author(s):  
Ada Man ◽  
Jeannette K Correa ◽  
Jessica Ziemek ◽  
Robert W Simms ◽  
David T Felson ◽  
...  

ObjectivesWe developed a patient-reported outcome (PRO) instrument to assess the skin-related quality of life in patients with systemic sclerosis (SSc).MethodsParticipants with SSc provided input on skin-related health effects through focus groups. We developed items for scleroderma skin PRO (SSPRO) to encompass these effects. Further consideration from cognitive interviews and an expert panel led to reduction and modification of items. A 22-item SSPRO was field tested. Psychometric analysis included test–retest reliability, internal consistency and exploratory factor analysis (EFA). Construct validity was assessed through correlation with other participant and physician-assessed measures.Results140 participants completed the SSPRO: mean age was 53.4 years, median disease duration was 5 years, 82.1% were female and 32.9% had diffuse cutaneous SSc. EFA supported four factors in SSPRO corresponding to hypothesised constructs: physical effects, physical limitations, emotional effects and social effects. Removal of 4/22 items resulted in acceptable goodness-of-fit statistics. Test–retest reliability (intraclass correlation coefficient=0.61–0.83) was moderate to high and internal consistency (Cronbach's α=0.89–0.96) was high. SSPRO correlated strongly with other participant-reported measures (r=0.59–0.88) suggesting construct validity, and less well with physician-assessed measures (r=0.31–0.40). SSPRO scores were significantly different for each level of participant-reported skin severity, and for limited versus diffuse cutaneous SSc.ConclusionsSSPRO has been developed with extensive patient input and demonstrates evidence for reliability and validity. It is complementary to existing measures of SSc skin involvement with emphasis on the patient's experience. Further research is needed to assess its sensitivity to change.


2018 ◽  
Vol 109 (2) ◽  
pp. 159-165 ◽  
Author(s):  
S. Hulkkonen ◽  
J. P. Repo ◽  
A. Häkkinen ◽  
J. Karppinen ◽  
J. Ryhänen

Background and Aims: Michigan Hand Outcomes Questionnaire is a widely used patient-reported outcome measure in hand surgery. The aim of this study was to translate and validate the Michigan Hand Outcomes Questionnaire into Finnish for Finnish patients with hand problems following international standards and guidelines. Material and Methods: The original English Michigan Hand Outcomes Questionnaire was translated into Finnish. Altogether, 115 patients completed the Finnish Michigan Hand Outcomes Questionnaire, and reference outcomes: Disabilities of the Arm and Shoulder, EQ-5D 3L and pain intensity on a visual analog scale. Grip and key pinch forces were measured. After 1–2 weeks, 63 patients completed the Finnish Michigan Hand Outcomes Questionnaire the second time. The Michigan Hand Outcomes Questionnaire was analyzed for internal consistency, repeatability, correlations with the reference outcomes, and factor analysis. Results: Cronbach’s alpha ranged from 0.90 to 0.97 in all the Michigan Hand Outcomes Questionnaire subscales, showing high internal consistency. The intraclass correlation coefficient showed good to excellent test–retest reliability ranging from 0.66 to 0.91 in all the Michigan Hand Outcomes Questionnaire subscales. In factor analysis, the structure with six subscales was not confirmed. All the subscales correlated with Disabilities of the Arm and Shoulder score, and five subscales correlated with EQ-5D index. Conclusion: The Finnish version of the Michigan Hand Outcomes Questionnaire showed similar properties compared to the original English version and thus can be used as patient-reported outcome measure for Finnish patients with hand problems.


Author(s):  
Rebecca McKeown ◽  
David R. Ellard ◽  
Abdul-Rasheed Rabiu ◽  
Eleni Karasouli ◽  
Rebecca S. Kearney

Abstract Background Ankle fractures are painful and debilitating injuries that pose a significant burden to society and healthcare systems. Patient reported outcome measures (PROMs) are commonly used outcome measures in clinical trials of interventions for ankle fracture but there is little evidence on their validity and reliability. This systematic review aims to identify and appraise evidence for the measurement properties of ankle specific PROMs used in adults with an ankle fracture using Consensus Based Standards for the Selection of Health Measurement Instrument (COSMIN) methodology. Methods We searched MEDLINE, Embase and CINAHL online databases for evidence of measurement properties of ankle specific PROMs. Articles were included if they assessed or described the development of the PROM in adults with ankle fracture. Articles were ineligible if they used the PROM to assess the measurement properties of another instrument. Abstracts without full articles and conference proceedings were ineligible, as were articles that adapted the PROM under evaluation without any formal justification of the changes as part of a cross-cultural validation or translation process. Two reviewers completed the screening. To assess methodological quality we used COSMIN risk of bias checklist and summarised evidence using COSMIN quality criteria and a modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Two reviewers assessed the methodological quality and extracted the data for a sample of articles. Results The searches returned a total of 377 articles. From these, six articles were included after application of eligibility criteria. These articles evaluated three PROMs: A-FORM, OMAS and AAOS. The A-FORM had evidence of a robust development process within the patient population, however lacks post-formulation testing. The OMAS showed sufficient levels of reliability, internal consistency and construct validity. The AAOS showed low quality evidence of sufficient construct validity. Conclusions There is insufficient evidence to support the recommendation of a particular PROM for use in adult ankle fracture research based on COSMIN methodology. Further validation of these outcome measures is required in order to ensure PROMs used in this area are sufficiently valid and reliable to assess treatment effects. This would enable high quality, evidenced-based management of adults with ankle fracture.


2017 ◽  
Vol 32 (2) ◽  
Author(s):  
Shannon Gwin ◽  
Paul Branscum ◽  
E. Laurette Taylor

The purpose of this study was to create a valid and reliable instrument to evaluate theory-basedbeliefs towards physical activity among clergy members. Data were collected from 174 clergy that par-ticipated in a 15-item online and paper-based survey. Psychometric properties of the instrument includedconfirmatory factor analysis (construct validity), and cronbach’s alpha (internal consistency reliability).In addition, the stability (test-retest reliability) of each subscale was evaluated with a sub-sample of 30participants. Results show the instrument was both valid and reliable, and will be useful in future studiestargeting this population. Future implications are discussed.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24027-e24027
Author(s):  
Jaba Kokhreidze ◽  
Veleka Allen ◽  
Cristina Ivanescu ◽  
Xiaopan Valerie Yao ◽  
Bin Zhang ◽  
...  

e24027 Background: The ongoing two-part phase 2/3 RESILIENT study (NCT03088813) is investigating the efficacy and safety of liposomal irinotecan monotherapy in patients with SCLC who have progressed on or after first line platinum-based chemotherapy. This exploratory analysis from RESILIENT part 1 was conducted to confirm the psychometric properties of established PRO instruments that had not previously been validated in patients with SCLC. Methods: Patients completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) Core 30 (C30) and the EORTC QLQ Lung Cancer 13 (LC13) before treatment assignment (baseline), every 6 weeks thereafter, at treatment discontinuation and at the 30-day follow-up visit. Psychometric methods included descriptive statistics (items and scales), correlations (item-to-item and item-to-total), internal consistency (Cronbach’s α), test-retest reliability (intraclass correlation coefficient [ICC], two-way random effects model), construct validity and sensitivity to change. The analysis included patients who received at least one dose of study drug and completed at least one PRO assessment. Results: Thirty patients were enrolled in RESILIENT part 1 and included in the analysis. At baseline, 68% of patients reported ‘not severe’ or ‘mild’ symptoms. Floor effects (i.e. more than 25% of responses of ‘not at all’) were observed for several of the functioning/impact and symptom scales of the EORTC QLQ C30 and LC13. Moderate to strong correlations were found among most questionnaire items within their respective scales. Acceptable evidence for internal consistency and good test-retest reliability were observed. Selected results for the EORTC QLQ LC13, including dyspnea scales, are shown in the Table. The magnitude of correlations among PRO instruments supported evidence for convergent validity in this sample. Conclusions: In RESILIENT part 1, patients experienced low and tolerable symptoms at enrollment, limiting the potential for further improvement. Overall, these PRO instruments had acceptable psychometric properties (e.g. construct validity, reliability and ability to detect change) in this sample. However, these analyses should be repeated in a larger sample using data from RESILIENT part 2. Clinical trial information: NCT03088813. [Table: see text]


2016 ◽  
Vol 46 (12) ◽  
pp. 2210-2215 ◽  
Author(s):  
Luísa Carneiro Vasconcelos Basto Gonçalves ◽  
Ana Daniela Gomes Araújo Simões ◽  
Darryl Lynn Millis ◽  
Augusto José Ferreira de Matos

ABSTRACT: The purpose of this study was to develop and to assess the psychometric characteristics of a mobility scale for dogs. The original ten questions were reduced using validation process. One hundred and twenty three dog owners were invited to answer the questionnaire. Internal consistency, factor analysis, floor and ceiling effect and construct validity were studied. Good internal consistency (Cronbach's Alpha=0.854) was determined with two items eliminated. The instrument comprises 8 final questions, each of which has five possible answers (never, rarely, sometimes, often and always) scored between 0 and 4 or between 4 and 0 (for the items with inverse score). Three hypotheses proposed for the construct validity were verified: 1) gender does not influence dog mobility (P=0.584); 2) mobility decreases with age (P<0.001); 3) dogs with orthopaedic or neurological diagnosed pathologies have less mobility (median score (P25; P75) 46.9% (31.3; 68.8)) than healthy dogs (median score (P25; P75) 81.3% (71.9; 93.8)) (P<0.001). Total score range was 0 to 32 points, with higher values indicating greater mobility of dogs. The Dog Mobility Scale was capable of assessing mobility in dogs, with good psychometric characteristics, and is simple and inexpensive to apply in clinical practice.


2021 ◽  
Vol 12 ◽  
Author(s):  
Daniel Gregor Schulze ◽  
Kristian Bernhard Nilsen ◽  
Rikke Munk Killingmo ◽  
John Anker Zwart ◽  
Margreth Grotle

Background: Self-reported measures are often used in research and clinical practice to diagnose carpal tunnel syndrome (CTS) and guide therapeutic choices. We aimed to assess the clinical utility of the Norwegian versions of two self-reported outcome measures for symptom severity assessment, the 6-item CTS (CTS-6), and Boston-CTS (BCTQ), and of one diagnostic measure, the hand-diagram, by evaluating measurement properties including discriminative ability for severity assessment (CTS-6, BCTQ), and diagnosis of CTS (hand-diagram).Methods: We performed forward and backward translation and cultural adaptation of the Norwegian CTS-6 and BCTQ. Following COSMIN guidelines, we investigated internal consistency, reliability, construct validity, and discriminative ability for distinguishing between severity levels of CTS in patients with confirmed CTS for the CTS-6 and BCTQ and reliability and discriminative ability for diagnosing CTS for the hand-diagram.Results: Two hundred and fifty-one patients referred for diagnostic work-up for CTS with nerve conduction studies (NCS) participated. The CTS-6 and BCTQ had acceptable internal consistency (Crohnbach's α = 0.82 and 0.86, respectively), reliability (ICC = 0.86 and 0.90; SEM = 0.24 and 0.20; SDC95% = 0.68 and 0.55, respectively), construct validity (all eight pre-defined hypotheses confirmed) and discriminative ability to distinguish between severity levels of CTS [Area under the curve (AUC) = 0.75, 95% CI 0.64–0.85]. The hand-diagram had acceptable reliability (Cohen's kappa = 0.69) and discriminative ability to diagnose CTS (sensitivity = 0.72, specificity = 0.90).Conclusion: Our findings support the clinical utility of the CTS-6 and BCTQ for symptom severity assessment and of the hand-diagram for diagnostic screening.


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