Measurement Properties of the Psoriasis Symptom Inventory Electronic Daily Diary in Patients with Moderate to Severe Plaque Psoriasis

Objectives

The Psoriasis Symptom Inventory (PSI) is a patient-reported outcome instrument that measures the severity of psoriasis signs and symptoms. This study evaluated measurement properties of the PSI in patients with moderate to severe plaque psoriasis.

Psychometric validation of the physician global assessment scale for assessing severity of psoriasis disease activity

Purpose

The Physician Global Assessment (PGA) is a key measure of psoriasis frequently used in clinical trials. A psychometric validation of a three-item (erythema, induration, and scaling) PGA scale was performed using Phase 2 data.

Methods

Confirmatory factor analysis (CFA) tested the PGA measurement model and appropriateness of equal weighting of the items. PGA test–retest reliability was assessed by estimating the intraclass correlation coefficient (ICC). Internal consistency reliability was gauged by calculating Cronbach’s coefficient α (CCα). Clinically important difference (CID) was defined using the repeated measures model to estimate the relationship between PGA and Patient Global Assessment (PtGA). Known-group, convergent, and divergent validity for the PGA were also assessed.

Results

197 patients with psoriasis were randomized to tofacitinib 2, 5, 15 mg twice daily, or placebo. CFA demonstrated that the PGA measurement model fitted the data using equal weighting of the PGA items. The PGA scale demonstrated good test–retest reliability (ICC > 0.7) and internal consistency reliability (CCα > 0.8). The CID for PGA was estimated at 0.52 (95 % confidence interval: 0.47, 0.56). A robust monotonic relationship between PGA and Psoriasis Area and Severity Index (PASI) data substantiated known-group validity. Relatively high correlations of PGA with PASI and PtGA data (all correlations >0.5 except at baseline) supported convergent validity; relatively low correlations of PGA with the Pain/Discomfort Assessment and the Ocular Comfort Index supported divergent validity.

Conclusions

The three-item PGA scale has sound psychometric properties with respect to reliability and validity, with equal weighting of the items being appropriate.     

Equivalence and measurement properties of an electronic version of the Psoriasis Symptom Inventory

Purpose

To evaluate the equivalence of electronic and paper versions of the Psoriasis Symptom Inventory and to examine measurement properties of the electronic version.

Methods

In a prospective, randomized, crossover, non-interventional study in adult subjects (age ≥18 years) with plaque psoriasis conducted over a period of 15 days, subjects were randomized to two groups, completing either the paper or electronic Psoriasis Symptom Inventory daily for 7 consecutive days followed by the alternate version. Equivalence was assessed by the intraclass correlation coefficient (ICC) between both administration modes. Differences in scores were also tested using paired Student’s t test. Measurement properties included internal consistency reliability, test–retest reliability, and convergent and discriminant validity between the Psoriasis Symptom Inventory and (1) disease-specific (Dermatology Life Quality Index) and (2) general health (SF-36v2) status.

Results

Eighty subjects [74 % (59/80) moderate-to-severe psoriasis; 26 % (21/80) mild psoriasis receiving systemic treatment] were enrolled from 8 sites in the USA. The two modes were highly concordant for both total (ICC = 0.97) and individual item scores (ICC range = 0.93–0.97). Response bias testing showed no differences based on completion order with all ICC values >0.91. All mean score differences, except for one item (“flaking”), were non-significant (P > 0.05). Minimum values for reliability (>0.70) and validity (convergent, r ≥ 0.40) were exceeded for the electronic Psoriasis Symptom Inventory.

Conclusions

Equivalence between paper and electronic versions of the Psoriasis Symptom Inventory and strong measurement properties of the electronic mode indicated a successful migration from paper to electronic format of the Psoriasis Symptom Inventory.     

Cross-Cultural Validation of the Scales for Outcomes in Parkinson's Disease-Psychosocial Questionnaire (SCOPA-PS) in Four Latin American Countries

ObjectiveTo conduct a cross-national validation of the Scales for Outcomes in Parkinson's Disease-PsychoSocial questionnaire (SCOPA-PS) in four Latin American Countries.MethodsData quality (missing items), scale assumptions (item–test correlation), internal consistency (Cronbach's alpha, item homogeneity), factor structure, content validity, and precision (standard error of measurement, SEM) of the scale were explored, as was convergent validity with motor symptoms (Clinical Impression of Severity Index [CISI-PD], Scales for Outcomes in Parkinson's Disease-Motor Scale), emotional status (Hospital Anxiety and Depression Scale) and health-related quality of life (Parkinson Disease Questionnaire-39). Known-groups validity was studied by category of severity, based on Hoehn and Yahr staging (HY), CISI-PD, and disease duration.ResultsThree hundred thirty-one Parkinson's disease (PD) patients with usable data participated (mean age 64.7 years; 42.3% female; mean PD duration 8.5 years; HY, 1 to 5). Data quality (missing items <10%), scale assumptions (item–total correlation = 0.43 ? 0.71) and internal consistency of SCOPA-PS (Cronbach's alpha = 0.87; item homogeneity = 0.38) were satisfactory. Factor analysis suggested a unifactorial structure. High convergent validity was found for depression (r_S = 0.61), anxiety (r_S = 0.62), and health-related quality of life (r_S = 0.82). Known-groups validity analyses indicated a gradual influence of severity category and disease duration on SCOPA-PS scores (P < 0.0001). SEM value was 8.24 (7 to 12 in previous studies). These magnitudes may be indicative of the threshold for a real change and a minimum important difference.ConclusionsThe Latin American versions of the SCOPA-PS displayed appropriate psychometric attributes.     

The PROMIS Physical Function item bank was calibrated to a standardized metric and shown to improve measurement efficiency

ObjectiveTo document the development and psychometric evaluation of the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) item bank and static instruments.Study Design and SettingThe items were evaluated using qualitative and quantitative methods. A total of 16,065 adults answered item subsets (n > 2,200/item) on the Internet, with oversampling of the chronically ill. Classical test and item response theory methods were used to evaluate 149 PROMIS PF items plus 10 Short Form-36 and 20 Health Assessment Questionnaire-Disability Index items. A graded response model was used to estimate item parameters, which were normed to a mean of 50 (standard deviation [SD] = 10) in a US general population sample.ResultsThe final bank consists of 124 PROMIS items covering upper, central, and lower extremity functions and instrumental activities of daily living. In simulations, a 10-item computerized adaptive test (CAT) eliminated floor and decreased ceiling effects, achieving higher measurement precision than any comparable length static tool across four SDs of the measurement range. Improved psychometric properties were transferred to the CAT's superior ability to identify differences between age and disease groups.ConclusionThe item bank provides a common metric and can improve the measurement of PF by facilitating the standardization of patient-reported outcome measures and implementation of CATs for more efficient PF assessments over a larger range.     

Development of the Bleeding and Pelvic Discomfort Scale for Use in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

ObjectivesThis study aimed to define a cardinal symptom burden measure based on items from the Uterine Fibroid Symptom and Quality of Life questionnaire for use as a clinical trial endpoint.MethodsExploratory factor analysis was computed to assess the Uterine Fibroid Symptom and Quality of Life symptom severity scale factor structure, using phase 2 data. Pooled blinded data from phase 3 studies were used for the confirmatory factor analysis and the psychometric evaluation of the new measure. Exit interviews in 30 patients from phase 3 studies provided additional qualitative evidence. A meaningful change threshold was determined using anchor-based analyses supported by patient feedback in the exit interviews.ResultsThree factors emerged from the exploratory factor analysis. Factor 1, called the bleeding and pelvic discomfort (BPD) scale, consists of cardinal symptoms, measuring menstrual distress owing to heavy bleeding, passing blood clots, and feeling tightness or pressure in pelvic area. Patients generally understood the items in the scale and the recall period as intended. The BPD scale had good item performance and internal consistency reliability, strong item-to-total correlations, good item discrimination, known-groups validity, and ability to detect change. A 20-point change on the BPD scale was determined as the clinically meaningful change threshold.ConclusionsThe BPD scale assesses symptom burden owing to bleeding, passing blood clots, and pelvic pressure. The subscale is based on a subset of items selected to measure the cardinal symptoms of uterine fibroids in a clinical trial setting. The responder threshold evaluates whether patients experience a meaningful treatment benefit over the on-treatment period.     

Most of the Quality of Life in Essential Tremor Questionnaire (QUEST) psychometric properties resulted in satisfactory values

ObjectiveThis study sought to assess the psychometric attributes of the Quality of Life in Essential Tremor Questionnaire (QUEST) by undertaking an independent validation.Study Design and SettingThis was an observational, multicenter, cross-sectional study carried out in Neurology Departments of general hospitals. The following assessments were applied: Louis Rating Scale, Clinical Assessment of Tremor, Clinical Global Impression of Severity (CGI-ET), Hospital Anxiety and Depression Scale (HADS), EQ-5D, and QUEST (Spanish version).ResultsOne hundred and eighteen consecutive patients were included. According to the CGI-ET, most of patients had mild (42.4%) or moderate (43.2%) impact of tremor on performing daily activities. Fully computable QUEST data were 60.2%. The QUEST Summary Index (QUEST-SI) displayed marginal floor or ceiling effect. On the whole, QUEST internal consistency and reproducibility were satisfactory (Cronbach's alpha values: 0.73–0.86; QUEST-SI intraclass correlation coefficient: 0.77). Factor analysis identified eight factors (73.6% of the variance) that could be grouped into six, relatively coincident with the questionnaire's dimensions. The QUEST-SI correlated moderately with the EQ-5D index (r_S = ?0.40), HADS—Depression (r_S = 0.39), and CGI-ET (r_S = 0.39), and strongly with the QUEST scale for self-evaluation of tremor severity (r_S = 0.63). The standard error of measurement was 8.00.ConclusionApart from a substantial problem of acceptability, most of the tested psychometric attributes of the QUEST resulted satisfactory.     

Comparing the psychometric properties of the EQ-5D-3L and EQ-5D-5L descriptive systems and utilities in atopic dermatitis

Background

Atopic dermatitis (AD) is a common chronic inflammatory skin disorder affecting up to 10% of adults. The EQ-5D is the most commonly used generic preference-accompanied measure to generate quality-adjusted life years (QALYs) for economic evaluations.

Objectives

We aimed to compare psychometric properties of the three-level and five-level EQ-5D (EQ-5D-3L and EQ-5D-5L) in adult patients with AD.

Methods

In a multicentre cross-sectional study, 218 AD patients with a broad range of severity completed the EQ-5D-3L, EQ-5D-5L, Dermatology Life Quality Index (DLQI) and Skindex-16. Disease severity outcomes included the Investigator Global Assessment, Eczema Area and Severity Index and the objective SCORing Atopic Dermatitis.

Results

A good agreement was established between the two EQ-5D versions with an intraclass correlation coefficient of 0.815 (95% CI 0.758–0.859, p < 0.001). Overall, 33 different health state profiles occurred in the EQ-5D-3L and 84 in the EQ-5D-5L. Compared to the EQ-5D-3L, ceiling effect was reduced for the mobility, self-care, usual activities and pain/discomfort dimensions by 4.6–11.5%. EQ-5D-5L showed higher average relative informativity (Shannon’s evenness index: 0.64 vs. 0.59). EQ-5D-5L demonstrated better convergent validity with EQ VAS, DLQI and Skindex-16. The two measures were similar in distinguishing between groups of patients based on disease severity and skin-specific quality of life with a moderate or large effect size (η² = 0.083–0.489).

Conclusion

Both instruments exhibited good psychometric properties in AD; however, the EQ-5D-5L was superior in terms of ceiling effects, informativity and convergent validity. We recommend the use of the EQ-5D-5L to measure health outcomes in clinical settings and for QALY calculations in AD.

     

Reliability and Validity of the Work Instability Scale for Rheumatoid Arthritis

ObjectiveThe objective was to evaluate the psychometric properties of the Rheumatoid Arthritis-Work Instability Scale (RA-WIS) in a clinical trial setting.MethodsSecondary analyses were conducted using data from a 56-week, randomized controlled trial of patients with early rheumatoid arthritis (RA). Patient-reported outcome measures included the RA-WIS, the Health Assessment Questionnaire (HAQ), the Rheumatoid Arthritis Quality of Life Questionnaire, and the Global Assessment of Disease Activity and Pain, data for which were collected at baseline and at weeks 12, 16, 24, and 56. Data were analyzed for reliability, validity, and responsiveness.ResultsAmong 148 patients whose data were analyzed, more than half were women (56.1%) with a mean age of 46.8 years. On average, patients experienced RA symptoms for 8.7 months; the mean 28-Joint Disease Activity Score (DAS28) was 5.9, and the mean HAQ – Disability Index was 1.3. The RA-WIS demonstrated excellent internal consistency and test-retest reliability (α = 0.89 and intraclass correlation coefficient = 0.91, respectively). At baseline and week 24, moderate to strong correlations were seen between RA-WIS total scores and the HAQ, the Global Assessment of Disease Activity, and the Pain Rheumatoid Arthritis Quality of Life Questionnaire, ranging from 0.47 to 0.81 (all P < 0.0001). Mean RA-WIS total scores and work disability risk levels discriminated between clinical severity scores on the DAS28, the HAQ – Disability Index, and the Physician Global Assessment of Disease Activity (all P < 0.05). Mean baseline to week 24 RA-WIS total change scores were significantly different among American College of Rheumatology responder groups (P ≤ 0.0001) and between DAS28 remission status groups (P < 0.001).ConclusionsThese findings provide evidence supporting the reliability, validity, and responsiveness of the RA-WIS for evaluating work disability in patients with RA in a clinical trial setting.     

趋化因子CCL27在寻常型银屑病患者血清的表达以及与PASI的相关性

目的观察寻常型银屑病患者血清CCL27表达水平与PASI的相关性。方法采用ELISA方法，比较试验组（寻常型银屑病患者）与对照组（健康人）血清中CCL27表达水平；并比较试验组血清CCL27水平与PASI评分的相关性。结果寻常型银屑病组血清CCL27表达水平明显高于健康组，P〈0．01，CCL27在寻常型银屑病组血清的表达水平与PASI呈明显正相关（r=1000，P〈001）。结论患者血清CCL27水平与寻常型银悄病病情发生发展密切相关。     

Long-Term Efficacy of Etanercept for Plaque-Type Psoriasis and Estimated Cost in Daily Clinical Practice

BackgroundThere are numerous clinical trials proving efficacy and safety profiles of etanercept. Newer studies, however, include patients with significant comorbidities, unstable psoriasis, or concomitant treatments.ObjectiveThe objective of this study was to provide data on long-term response to etanercept and estimate the cost in daily practice.MethodsThis is an observational retrospective study including patients with plaque-type psoriasis receiving etanercept 50 mg/wk for more than 6 months at the Dermatology Department of the University Hospital of La Coruña (Spain). Psoriasis severity was determined using the Psoriasis Area and Severity Index (PASI) at baseline and then at 12 weeks, 24 weeks, and annually until treatment discontinuation.ResultsA total of 102 patients aged 24 to 78 years were included. Response rates of 58.8% and 66.3% for PASI 75 score (reduction of at least 75% in PASI score compared with baseline) were achieved after 12 and 24 weeks of treatment, respectively. Among patients who continued treatment, the PASI 75 score was maintained by 75.3% at 1 year, 82.5% at 2 years, and 88.2% at 3 years. The percentage of patients receiving other systemic treatments was 38.2%. Adverse effects were reported in 13.7%, all of them mild, except one case of urinary sepsis. The average cost per patient was €244.68 ± €45.27 per week and €34.95 ± €6.46 per day.ConclusionsWe provide data on long-term response to etanercept and its costs in a real-world setting. Response rates were higher than in some clinical trials, with progressive efficacy and not related to body mass index. Etanercept cost was comparable with that estimated in other studies. Combination with a conventional systemic agent can enhance efficacy without additional adverse events.     

Oral Administration of East Asian Herbal Medicine for Inflammatory Skin Lesions in Plaque Psoriasis: A Systematic Review,Meta-Analysis,and Exploration of Core Herbal Materials

Psoriasis is an inflammatory autoimmune skin disease with various clinical manifestations. The aim of this review was to systematically evaluate the efficacy and safety of oral administration of East Asian herbal medicine (EAHM) for inflammatory skin lesions in psoriasis and to explore core herbal materials for drug discovery. A comprehensive search was conducted in 10 electronic databases for randomized controlled trials from their inception until 29 July 2021. Statistical analysis was performed in R version 4.1.2 and R studio. When heterogeneity in studies was detected, the cause was identified through sensitivity analysis, meta-regression, and subgroup analysis. Methodological quality was independently assessed using the revised tool for risk of bias in randomized trials. A total of 56 trials with 4966 psoriasis patients met the selection criteria. Meta-analysis favored EAHM monotherapy on Psoriasis Area Severity Index (PASI) 70 (RR: 1.2845; 95% CI: 1.906 to 1.3858, p < 0.0001), PASI 60 (RR: 1.1923; 95% CI: 1.1134 to 1.2769, p < 0.0001), continuous PASI score (MD: −2.3386, 95% CI: −3.3068 to −1.3704, p < 0.0001), IL-17, IL-23, TNF-α, and Dermatology Life Quality Index. Patients treated with EAHM monotherapy had significantly reduced adverse events incidence rate. In addition, based on additional examination of the herb data included in this meta-analysis, 16 core materials were identified. They are utilized in close proximity to one another, and all have anti-inflammatory properties. The findings in this study support that oral EAHM monotherapy may be beneficial for inflammatory skin lesions in psoriasis. Meanwhile, the identified core materials are expected to be utilized as useful drug candidate hypotheses through follow-up studies on individual pharmacological activities and synergistic effects.     

The Nocturia Impact Diary: A Self-Reported Impact Measure to Complement the Voiding Diary

BackgroundNocturia is a chronic, fluctuating disease that disrupts sleep and has a wide-ranging impact on quality of life. Valid tools to measure the patient-reported impact of nocturia are essential for evaluating the value of treatment, but the available tools are suboptimal.ObjectivesThis study reports the development and validation of the Nocturia Impact Diary—an augmented form of the Nocturia Quality of Life questionnaire designed to be completed in conjunction with the widely used 3-day voiding diary.MethodsThe process comprised three steps: Step 1: Development of a concept pool using the Nocturia Quality of Life questionnaire and data from relevant studies; Step 2: Content validity study; Step 3: Psychometric testing of construct validity, reliability, and sensitivity of the diary in a randomized, placebo-controlled study in patients with nocturia.ResultsStep 1: Fourteen items and 4 domains were included in the first draft of the diary. Step 2: Twenty-three patients with nocturia participated in the cognitive debriefing study. Items were adjusted accordingly, and the content validity was high. Step 3: Fifty-six patients were randomized to desmopressin orally disintegrating tablet or placebo. The diary demonstrated high construct validity, with good sensitivity and a good fit to Rasch model, as well as high internal consistency, discriminatory ability, and acceptable sensitivity to change. Results indicated that the diary was unidimensional.ConclusionsThe Nocturia Impact Diary is a convenient, validated patient-reported outcome measure. It should be used in conjunction with a voiding diary to capture the real-life consequences of nocturia and its treatment.     

Item Reduction and Psychometric Validation of the Oily Skin Self Assessment Scale (OSSAS) and the Oily Skin Impact Scale (OSIS)

IntroductionDeveloped using focus groups, the Oily Skin Self Assessment Scale (OSSAS) and Oily Skin Impact Scale (OSIS) are patient-reported outcome measures of oily facial skin.ObjectiveThe aim of this study was to finalize the item-scale structure of the instruments and perform psychometric validation in adults with self-reported oily facial skin.MethodsThe OSSAS and OSIS were administered to 202 adult subjects with oily facial skin in the United States. A subgroup of 152 subjects returned, 4 to 10 days later, for test–retest reliability evaluation.ResultsOf the 202 participants, 72.8% were female; 64.4% had self-reported nonsevere acne. Item reduction resulted in a 14-item OSSAS with Sensation (five items), Tactile (four items) and Visual (four items) domains, a single blotting item, and an overall oiliness item. The OSIS was reduced to two three-item domains assessing Annoyance and Self-Image. Confirmatory factor analysis supported the construct validity of the final item-scale structures. The OSSAS and OSIS scales had acceptable item convergent validity (item-scale correlations >0.40) and floor and ceiling effects (<20%). Cronbach's alpha coefficients ranged from 0.83 to 0.89 for the OSSAS and 0.82 to 0.87 for the OSIS, demonstrating excellent internal consistency. The a priori test–retest reliability criterion (intraclass correlation [ICC] ≥0.7) was met for one of the three OSSAS domains and one of the two OSIS domains. OSSAS and OSIS domains distinguished among groups that differed in patient-reported facial oily skin severity (P < 0.0001), and bother associated with oily skin (P < 0.0001).ConclusionsThe OSSAS and OSIS versions tested in this study have been found to have strong psychometric properties in this patient sample (adults with self-reported oily facial skin), as assessments of self-reported oily facial skin severity and its emotional impact, respectively.     

Vision-related quality of life Core Measure (VCM1) showed low-impact differential item functioning between groups with different administration modes

ObjectiveTo assess psychometric quality of the vision-related quality of life core measure (VCM1) and feasibility in a community-based sample.Study Design and SettingCross-sectional data were used from an observational study among visually impaired patients (n = 296) and a community-based sample with low vision (n = 98) from the Longitudinal Aging Study Amsterdam. Calibration was performed within the graded response model on the patient sample, including item fit, differential item functioning (DIF), DIF impact, and psychometric information. DIF between both samples was investigated for assessing feasibility of the VCM1 in community-based studies.ResultsAll items fitted the model. There was no significant DIF within the patient sample, except between self-report and proxy report subgroups. The maximum difference in expected scores was ?0.42. Item information was highest for item 4 “depression” and lowest for item 1 “embarrassment.” Test information showed full coverage of the disability continuum. DIF was present between patient and community-based samples. However, DIF items had low impact on the expected test scores.ConclusionsDIF that was found on single items between administration type subgroups and sample subgroups was negligible at the level of the expected test scores. This means that DIF had no substantial impact on the VCM1. Therefore, psychometric quality and feasibility of the VCM1 can be considered satisfactory.     

Psychometric Analysis of the Abdominal Score From the Diary for Irritable Bowel Syndrome Symptoms–Constipation Using Phase IIb Clinical Trial Data

ObjectivesThe Diary for Irritable Bowel Syndrome Symptoms–Constipation (DIBSS-C) has been developed to assess the core signs and symptoms of irritable bowel syndrome with constipation (IBS-C). This article presents the psychometric evaluation of the DIBSS-C abdominal score.MethodsData for these analyses are from a multicenter phase IIb study in IBS-C patients (NCT02559206). Subjects completed a number of assessments via handheld electronic diary throughout the study. The analyses used the intent-to-treat population and were blinded to randomized treatment group. The analyses evaluated the reliability, validity, and responsiveness of the DIBSS-C abdominal score; identified an appropriate scoring algorithm; and determined thresholds for interpreting clinically meaningful changes at the individual level.ResultsThe correlations between the DIBSS-C abdominal symptom items (ie, abdominal pain, discomfort, and bloating) were strong (>0.75). Cronbach’s alpha for the abdominal symptom severity items was very strong (.94), indicating that the 3 abdominal symptom items produce a reliable score. The intraclass correlation coefficient for the abdominal score was 0.82, exceeding the threshold of 0.70 and indicating good test–retest reliability. Guyatt’s responsiveness statistic values all exceeded the threshold for a large effect of 0.80, so the DIBSS-C abdominal score can be considered highly responsive to change. Triangulation across 3 sets of anchor-based analyses indicated that a threshold of −2.0 points on the abdominal score is an appropriate threshold for identifying meaningful change.ConclusionsOverall, this study provides evidence that the DIBSS-C abdominal score is valid, reliable, responsive to change, and interpretable for assessing treatment benefit in patients with IBS-C.     

Development and evaluation of the PI-G: a three-scale measure based on the German translation of the PROMIS® pain interference item bank

Objective

Study aim was to translate the PROMIS^® pain interference (PI) item bank (41 items) into German, test its psychometric properties in patients with chronic low back pain and develop static subforms.

Methods

We surveyed N = 262 patients undergoing rehabilitation who were asked to fill out questionnaires at the beginning and 2 weeks after the end of rehabilitation, applying the Oswestry Disability Index (ODI) and Pain Disability Index (PDI) in addition to the PROMIS^® PI items. For psychometric testing, a 1-parameter item response theory (IRT) model was used. Exploratory and confirmatory factor analyses as well as reliability and construct validity analyses were conducted.

Results

The assumptions regarding IRT scaling of the translated PROMIS^® PI item bank as a whole were not confirmed. However, we succeeded in devising three static subforms (PI-G scales: PI mental 13 items, PI functional 11 items, PI physical 4 items), revealing good psychometric properties.

Conclusion

The PI-G scales in their static form can be recommended for use in German-speaking countries. Their strengths versus the ODI and PDI are that pain interference is assessed in a differentiated manner and that several psychometric values are somewhat better than those associated with the ODI and PDI (distribution properties, IRT model fit, reliability). To develop an IRT-scaled item bank of the German translations of the PROMIS^® PI items, it would be useful to have additional studies (e.g., with larger sample sizes and using a 2-parameter IRT model).     

Validation of the Modified Brief Pain Inventory-Exploratory Form in Surgery Patients

ObjectiveAn exploratory version of the Modified Brief Pain Inventory (mBPI-e) to measure acute post-operative pain, with new items on coughing, breathing, and concentration, was examined for their measurement properties.Study DesignThis is a secondary study using data from two randomized clinical trials: general surgery trial (N=1050) and coronary artery bypass graft (CABG) surgery trial (N=1636). The measurements used in the two trials were: 1) mBPI-e; 2) clinician and patient global evaluations of medications; and 3) pain intensity diary. The mBPI-e and pain intensity were collected for 10 days. Clinician and patient global evaluations of medication were collected twice. The analyses conducted were: 1) exploratory factor analysis (EFA); 2) confirmatory factor analysis (CFA); 3) item response theory (IRT); 4) internal consistency; 5) test-retest reliability; 6) concurrent validity; 7) known-group validity; and 8) responsiveness.ResultsPain severity, pain interference, and coughing and breathing factors were identified. Pain severity and pain interference subscale scores were constructed for mBPI-e. IRT analyses showed all items exhibited good item characteristics. Internal consistency was 0.85 for severity and 0.87 for interference. Test-retest reliability was 0.81 for severity and 0.71 for interference. Both severity and interference scores were correlated with diary-based pain intensity ratings (P <.0001). Mean severity and interference scores varied by physician and patient global ratings (P <.05). Severity and interference scores were responsive to changes in pain diary scores and physician global ratings (P <.001). There were no substantive differences in reliability or validity for sub-samples of surgery patients.ConclusionsThe original BPI has been used in clinical studies, and the mBPI has demonstrated good reliability and validity in CABG patients. Based on this study, the mBPI-e has also demonstrated good reliability and validity for assessing postoperative acute pain in CABG and general surgery patients.     

Élaboration et qualités psychométriques d’une échelle de bien-être au travail. Étude SERENAT auprès de salariés vus en médecine du travail

BackgroundWell-being at work is nowadays a major public health challenge. It includes, among others, absence of psychological (anxio-depressive) symptoms, perceived positive work conditions (environment and organization), happiness and good quality of life at work. Many studies have shown that social support and control at work protect mental health while high job demands and effort-reward imbalance are risk factors for anxiety and depression. There is currently no global indicator to measure both the state of mental health and social working conditions. The main objective of this work is to construct and explore the psychometric properties of scale of well-being at work called “Serenat” in order to validate it.MethodsThe Serenat Scale is a self-report questionnaire composed of 20 items. All items are scored on a four-point Likert scale ranging from 0 (strongly disagree) to 3 (strongly agree) resulting in a range of 0 to 60. It was constructed from data collected from the literature and from consultations in an Occupational Health Unit. From January 2014 to May 2017 193 subjects who have consulted an occupational doctor are included in this cross sectional survey. Validation included item quality and data structure diagnosis, internal consistency, intraobserver reliability evaluation and external consistency.ResultsThe Serenat scale showed very good item quality, with a maximal non-response rate of 0.01 % per item, and no floor effect. Factor analysis concluded that the scale can be considered unidimensional. Cronbach's alpha of internal consistency was 0.89. The intraclass correlation coefficient for intraobserver reliability was 0.89. Serenat scale was correlated with HADS (r = −0.54; P < 0.001), STAI-Y (r = −0.78; P < 0.001) and BDI-13 (r = −0.57; P < 0.001).ConclusionSerenat's well-being at work scale shows good psychometric properties for final validation. It could be useful to occupational physicians for individual and collective screening.Trial RegistrationClinicalTrials.gov ID: NCT02905071.