The usability of an AAC pain description system for patients with acquired expressive communication disorders.

Augmentative and alternative communication (AAC) has been used by patients with acquired expressive communication disorders as an alternative to natural speech. The use of symbols to express pain, which is intangible, is challenging because designing a series of comprehensible symbols to represent personal experiences such as pain is not straightforward. This study describes (a) the development of symbols to express pain that were derived from Chinese pain-related similes and metaphors for an AAC mobile application developed specifically for this study known as PainDiary and (b) an assessment of the appropriateness of the app compared to conventional methods of collecting pain information. The symbols depicted headache pain and discomfort, which is prevalent among neurosurgical patients. The participants were 31 patients diagnosed with acquired expressive communication disorders who were receiving treatment in a neurosurgery general ward of Chang Gung Memorial Hospital in Taiwan and 14 nurses who worked on the ward. Pain information was collected by nurses using conventional methods and the PainDiary app. Assessment data, including the accuracy and efficiency of and user satisfaction with PainDiary, are compared. The results show that use of the app was effective in reporting pain and that patients required less time to report a pain event. The results further indicate that the PainDiary app was better received by younger individuals than by their older counterparts.

Implications of nocebo in anaesthesia care.

Nocebo refers to non-pharmacological adverse effects of an intervention. Well-intended procedural warnings frequently function as a nocebo. Both nocebo and placebo are integral to the generation of 'real' treatment effects and their associated 'real' side-effects. They are induced or exacerbated by: context; negative expectancy; and negative conditioning surrounding treatment. Since the late 1990s, the neuroscience literature has repeatedly demonstrated that the nocebo effect is mediated by discrete neurobiological mechanisms and specific physiological modulations. Although no single biological mechanism has been found to explain the nocebo effect, nocebo hyperalgesia is thought to initiate from the dorsal lateral prefrontal cortex subsequently triggering the brain's descending pain modulatory system and other pain regulation pathways. Functional magnetic resonance imaging shows that expectation of increased pain is accompanied by increased neural activity in the hippocampus and midcingulate cortex which is not observed when analgesia is expected. Functional magnetic resonance imaging studies have shown that the anterior cingulate cortex is pivotal in the perception of affective pain evoked by nocebo words. Research has also explored neurotransmitters which mediate the nocebo effect. The neuropeptide cholecystokinin appears to play a key role in the modulation of pain by nocebo. Hyperalgesia generated by nocebo also increases the activity of the hypothalamic-pituitary-adrenal axis as indicated by increases in plasma cortisol. The avoidance or mitigation of nocebo needs to be recognised as a core clinical skill in optimising anaesthesia care. Embracing the evidence around nocebo will allow for phrases such as 'bee sting' and 'sharp scratch' to be thought of as clumsy verbal relics of the past. Anaesthesia as a profession has always prided itself on practicing evidence-based medicine, yet for decades anaesthetists and other healthcare staff have communicated in ways counter to the evidence. The premise of every interaction should be 'primum non nocere' (first, do no harm). Whether the context is research or clinical anaesthesia practice, the nocebo can be ignored no longer.

Subgrouping of Peripheral Neuropathic Pain Patients According to Sensory Symptom Profile Using the Korean Version of the PainDETECT Questionnaire.

BACKGROUND: A culturally validated Korean version of the PainDETECT Questionnaire (PD-Q) was used to identify neuropathic pain components (NeP) in patients suffering from chronic pain. The purpose of this study was to determine if the Korean PD-Q can be used to subgroup patients with peripheral NeP according to sensory symptom profiles. METHODS: This study included 400 Korean patients with peripheral neuropathic pain diagnosed as probable or definite NeP. The total scores and subscores for each item in PD-Q were transformed into a Z-score for standardization. Hierarchical cluster analysis was performed to identify clusters of subjects by PD-Q scores. RESULTS: The mean total PD-Q score of the study participants was 14.57 ± 6.46. A hierarchical cluster analysis identified 5 clusters with distinct pain characteristic profiles. Cluster 1 had relatively severe burning and tingling sensations. The mean total PD-Q score for cluster 2 was the lowest of the 5 clusters. Cluster 3 tended to be vulnerable to pain in response to cold/heat stimulation. Cluster 4 showed relatively severe pain induced by physical stimuli, such as light touch or slight pressure. Cluster 5 had high scores for all NeP symptoms. CONCLUSION: This study demonstrates the ability of patients to cluster by symptoms using the Korean PD-Q. Subgrouping of peripheral neuropathic pain by sensory symptom profile may be useful in making effective drug treatment decisions.

Clinical Interpretation of Self-Reported Pain Scores in Children with Acute Pain.

OBJECTIVE: To identify self-reported pain scores that best represent categories of no pain, mild, moderate, and severe pain in children, and a pain score that accurately represents a child's perceived need for medication, that is, a minimum pain score at which a child would want an analgesic. STUDY DESIGN: Prospective cross-sectional cohort study of children aged 6-17 years presenting to a pediatric emergency department with painful and nonpainful conditions. Pain was measured using the 10-point Verbal Numerical Rating Scale. Receiver operating characteristic -based methodology was used to determine pain scores that best differentiated no pain from mild pain, mild pain from moderate pain, and moderate pain from severe pain. Descriptive statistics were used to determine the perceived need for medication. RESULTS: We analyzed data from 548 children (51.3% female, 61.9% with a painful condition). The scores that best represent categories of pain intensity are as follows: 0-1 for no pain; 2-5 for mild pain; 6-7 for moderate pain; and 8-10 for severe pain. The area under the curve for the cut points differentiating each category ranged from 0.76 to 0.88. The median pain score representing the perceived need for medication was 6 (IQR, 4-7; range, 0-10). CONCLUSIONS: We identified population-level self-reported pain scores in children associated with categories of pain intensity that differ from scores conventionally used. Implementing our findings may provide a more accurate representation of the clinical meaning of pain scores and reduce selection bias in research. Our findings do not support the use of pain scores in isolation for clinical decision making or the use of a pain score threshold to represent a child's perceived need for medication.

Clinical Utility of CAT Administered PROMIS Measures to Track Change for Pediatric Chronic Pain.

Patient Reported Outcomes (PROs) are utilized in clinical registries and trials, necessitating development of benchmarks to enhance interpretability. This study aimed to 1) examine if PROMIS measures administered via computer adaptive testing (CAT) were responsive to change, and 2) highlight one method of assessing clinically significant change for youth seen in a tertiary pain clinic. Clinically significant change was achieved if patients had significantly reliable pre-to-post-changes greater than Reliable Change Index (RCI) value and reported decreased symptoms by at least one severity level (e.g., moderate to mild). Participants were 328 youth (8-17 years old) seen in a tertiary pediatric pain management clinic. Small to moderate effect sizes were noted across PROMIS measures (except Peer Relations). Reliable magnitudes of change were estimated for this sample as approximately 6 point reduction for Pain Interference and Mobility, 9 for Fatigue, and 11 for Anxiety and Depression. Depending on the measure, 10 to 24% were categorized as improved, 3 to 6% as deteriorated, and 68 to 81% were either not clinically elevated at baseline or remained unchanged at 3 months. Overall, PROMIS CAT measures demonstrated responsiveness to change over time. Estimation of clinically significant change offers preliminary yet rigorous benchmarks for evaluating treatment response and sets the stage for understanding treatment effects. PERSPECTIVE: This study assesses responsiveness of CAT administered PROMIS measures and highlights one methodological approach of presenting clinical significance for assessing treatment outcomes in pediatric chronic pain. These benchmarks will allow clinicians and researchers to evaluate treatment response utilizing PROs while allowing for a deeper understanding of treatment effects.

ABCDEF Bundle Practices for Critically Ill Children: An International Survey of 161 PICUs in 18 Countries.

OBJECTIVES: To evaluate current international practice in PICUs regarding components of the "Assessing Pain, Both Spontaneous Awakening and Breathing Trials, Choice of Sedation, Delirium Monitoring/Management, Early Exercise/Mobility, and Family Engagement/Empowerment" (ABCDEF) bundle. DESIGN: Online surveys conducted between 2017 and 2019. SETTING: One-hundred sixty-one PICUs across the United States (n = 82), Canada (n = 14), Brazil (n = 27), and Europe (n = 38) participating in the Prevalence of Acute Rehabilitation for Kids in the PICU study. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Of the 161 participating PICUs, 83% were in academic teaching hospitals and 42% were in free-standing children's hospitals. Median size was 16 beds (interquartile range, 10-24 beds). Only 15 PICUs (9%) had incorporated all six ABCDEF bundle components into routine practice. Standardized pain assessment (A) was the most common (91%), followed by family engagement (F, 88%) and routine sedation assessment (C) with validated scales (84%). Protocols for testing extubation readiness or conducting spontaneous breathing trials (B) were reported in 57%, with 34% reporting a ventilator weaning protocol. Routine delirium monitoring with a validated screening tool (D) was reported by 44% of PICUs, and 26% had a guideline, protocol, or policy for early exercise/mobility (E). Practices for spontaneous breathing trials were variable in 29% of Canadian PICUs versus greater than 50% in the other regions. Delirium monitoring was lowest in Brazilian PICUs (18%) versus greater than 40% in other regions, and family engagement was reported in 55% of European PICUs versus greater than 90% in other regions. CONCLUSIONS: ABCDEF bundle components have been adopted with substantial variability across regions. Additional research must rigorously evaluate the efficacy of specific elements with a focus on B, D, E, and full ABCDEF bundle implementation. Implementation science is needed to facilitate an understanding of the barriers to ABCDEF implementation and sustainability with a focus on specific cultural and regional differences.

Pediatric Pain Screening Tool: A Simple 9-Item Questionnaire Predicts Functional and Chronic Postsurgical Pain Outcomes After Major Musculoskeletal Surgeries.

Reliable, clinic-friendly screening for Chronic postsurgical pain (CPSP) risk is unavailable. Within a prospective, observational study, we evaluated Pediatric Pain Screening Tool (PPST), a concise 9-item questionnaire, as a preoperative screening tool to identify those at higher risk for CPSP (Numerical Rating Scale > 3/10 beyond 3 months post-surgery) and poor function (disability/Functional Disability Inventory [FDI]/quality of life/ Pediatric Quality of Life) after spine fusion and Nuss procedures. Incidence of CPSP was 34.86% (38/109). We confirmed PPST scale stability, test re-test reliability (ICC = 0.68; P< .001); PPST measures were positively correlated with known CPSP risk factors (P< .001) preoperative pain (Pearson or Spearman Correlation Coefficient [SCC]:0.672), Child anxiety sensitivity index (SCC:0.357), Patient Related Outcome Measures Information System pain interference (SCC:0.569), Patient Related Outcome Measures Information System depression (SCC:0.501), Pediatric Quality of Life (SCC:-0.460) and insomnia severity index (SCC0.567). Preoperative PPST and PPST physical sub-scores (median(IQR) were higher in CPSP (2[0.5,4], 1[0,2]) compared to non-CPSP (1[0,3], 0[0,1.5]) groups (P= .026, P= .029) respectively. PPST scores/sub-scores positively correlated with higher FDI at 6 months but only PPST total and PPST psychosocial subscore correlated with higher FDI at 12 months. Based on ROC, optimal PPST cutoff for CPSP was 2 (63.9% sensitivity, 64.7% specificity). CPSP risk was high (48.94% risk) if PPST ≥ 2 (n = 47) and medium (22.81%) if PPST < 2 (n = 57) after spine/pectus surgery. General and risk-strata specific, targeted psychosocial non-pharmacological interventions, need to be studied. Findings need validation in diverse, larger cohorts. CLINICALTRIALS.GOV IDENTIFIER: NCT02998138. PERSPECTIVE: The article supports Pediatric Pain Screening Tool, a simple 9-item questionnaire, as a preoperative screening tool for CPSP and function 6-12 months after spine/pectus surgeries. PPST measures correlate with known risk factors for CPSP. Risk stratification and targeted preventive interventions in high-risk subjects are proposed.

Gold Standard for Diagnosis of DPN.

Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus. It often causes symmetrical paresthesia, loss of sensation, and hyperalgesia. Without early intervention, it might lead to diabetic foot ulceration, gangrene, and subsequent amputation in people with diabetes. DPN is an insidious disease and often underdiagnosed. This paper reviews the current national and international prevalence of DPN, screening methods for early DPN, including quantitative sensory measurement, neurological function scoring system, confocal microscopy, and high-frequency ultrasound, and summarizes the related research progress, clinical application, and development prospects of these methods in recent years.

Evaluation of the EQ-5D-3L and 5L versions in low back pain patients.

BACKGROUND: The EuroQol EQ-5D is one of the most widely researched and applied patient-reported outcome measures worldwide. The original EQ-5D-3L and more recent EQ-5D-5L include three and five response categories respectively. Evidence from healthy and sick populations shows that the additional two response categories improve measurement properties but there has not been a concurrent comparison of the two versions in patients with low back pain (LBP). METHODS: LBP patients taking part in a multicenter randomized controlled trial of lumbar total disc replacement and conservative treatment completed the EQ-5D-3L and 5L in an eight-year follow-up questionnaire. The 3L and 5L were assessed for aspects of data quality including missing data, floor and ceiling effects, response consistency, and based on a priori hypotheses, associations with the Oswestry Disability Index (ODI), Pain-Visual Analogue Scales and Hopkins Symptom Checklist (HSCL-25). RESULTS: At the eight-year follow-up, 151 (87%) patients were available and 146 completed both the 3L and 5L. Levels of missing data were the same for the two versions. Compared to the EQ-5D-5L, the 3L had significantly higher floor (pain discomfort) and ceiling effects (mobility, self-care, pain/discomfort, anxiety/depression). For these patients the EQ-5D-5L described 73 health states compared to 28 for the 3L. Shannon's indices showed the 5L outperformed the 3L in tests of classification efficiency. Correlations with the ODI, Pain-VAS and HSCL-25 were largely as hypothesized, the 5L having slightly higher correlations than the 3L. CONCLUSION: The EQ-5D assesses important aspect of health in LBP patients and the 5L improves upon the 3L in this respect. The EQ-5D-5L is recommended in preference to the 3L version, however, further testing in other back pain populations together with additional measurement properties, including responsiveness to change, is recommended. TRIAL REGISTRATION: retrospectively registered: https://clinicaltrials.gov/ct2/show/NCT01704677 .

Cross-Sectional Associations Among Symptoms of Pain, Irritability, and Depression and How These Symptoms Relate to Social Functioning and Quality of Life: Findings From the EMBARC and STRIDE Studies and the VitalSign6 Project.

OBJECTIVE: The aim of this report was to evaluate the psychometric properties of the Pain Frequency, Intensity, and Burden Scale (P-FIBS), a brief measure of pain, as well as the association of pain with irritability and depression and how these symptoms relate to functional impairments. METHODS: Participants of 2 randomized controlled trials (Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care [EMBARC; n = 251 with DSM-IV diagnosis of major depressive disorder; study duration: August 2011-December 2015] and STimulant Reduction Intervention Using Dosed Exercise [STRIDE; n = 302 with DSM-IV diagnosis of stimulant abuse or dependence; study-duration: July 2010-February 2013]) and treatment-seeking patients in primary care clinics from an ongoing quality-improvement project (VitalSign6; n = 4,370; project duration: August 2014-July 2019) were included. Psychometric properties of the P-FIBS were evaluated with confirmatory factor and item response theory analyses in EMBARC and VitalSign6. The approach of Baron and Kenny was used to assess whether irritability accounted for the effect of pain on depression. RESULTS: Cronbach α (0.84-0.89) and model fits for single-factor structure of P-FIBS were acceptable. Pain was positively correlated with irritability (r = 0.22-0.29) and depression (r = 0.10-0.33). Irritability accounted for 40.7%-65.5% of the effect of pain on depression. Higher irritability and depression were associated with poorer social functioning, quality of life, and productivity in work- and non-work-related activities. Pain was associated with non-work-related activity impairments even after controlling for irritability and depression. CONCLUSIONS: The P-FIBS is a brief and reliable measure of pain. Irritability is associated with pain and accounts for a large proportion of the effect of pain on depression. Symptoms of pain, irritability, and depression are associated with functional impairments. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT01407094 (EMBARC), NCT01141608 (STRIDE).

Validation of the Critical-Care Pain Observation Tool-Neuro in brain-injured adults in the intensive care unit: a prospective cohort study.

BACKGROUND: Pain assessment in brain-injured patients in the intensive care unit (ICU) is challenging and existing scales may not be representative of behavioral reactions expressed by this specific group. This study aimed to validate the French-Canadian and English revised versions of the Critical-Care Pain Observation Tool (CPOT-Neuro) for brain-injured ICU patients. METHODS: A prospective cohort study was conducted in three Canadian and one American sites. Patients with a traumatic or a non-traumatic brain injury were assessed with the CPOT-Neuro by trained raters (i.e., research staff and ICU nurses) before, during, and after nociceptive procedures (i.e., turning and other) and non-nociceptive procedures (i.e., non-invasive blood pressure, soft touch). Patients who were conscious and delirium-free were asked to provide their self-report of pain intensity (0-10). A first data set was completed for all participants (n = 226), and a second data set (n = 87) was obtained when a change in the level of consciousness (LOC) was observed after study enrollment. Three LOC groups were included: (a) unconscious (Glasgow Coma Scale or GCS 4-8); (b) altered LOC (GCS 9-12); and (c) conscious (GCS 13-15). RESULTS: Higher CPOT-Neuro scores were found during nociceptive procedures compared to rest and non-nociceptive procedures in both data sets (p < 0.001). CPOT-Neuro scores were not different across LOC groups. Moderate correlations between CPOT-Neuro and self-reported pain intensity scores were found at rest and during nociceptive procedures (Spearman rho > 0.40 and > 0.60, respectively). CPOT-Neuro cut-off scores ≥ 2 and ≥ 3 were found to adequately classify mild to severe self-reported pain ≥ 1 and moderate to severe self-reported pain ≥ 5, respectively. Interrater reliability of raters' CPOT-Neuro scores was supported with intraclass correlation coefficients > 0.69. CONCLUSIONS: The CPOT-Neuro was found to be valid in this multi-site sample of brain-injured ICU patients at various LOC. Implementation studies are necessary to evaluate the tool's performance in clinical practice.

Stability analysis of clustering of Norris' visual analogue scale: Applying the consensus clustering approach.

ABSTRACT: Visual analogue scales are widely used to measure subjective responses. Norris' 16 visual analogue scales (N_VAS) measure subjective feelings of alertness and mood. Up to now, different scientists have clustered items of N_VAS into different ways and Bond and Lader's way has been the most frequently used in clinical research. However, there are concerns about the stability of this clustering over different subject samples and different drug classes. The aim of this study was to test whether Bond and Lader's clustering was stable in terms of subject samples and drug effects. Alternative clustering of N_VAS was tested.Data from studies with 3 types of drugs: cannabinoid receptor agonist (delta-9-tetrahydrocannabinol [THC]), muscarinic antagonist (scopolamine), and benzodiazepines (midazolam and lorazepam), collected between 2005 and 2012, were used for this analysis. Exploratory factor analysis (EFA) was used to test the clustering algorithm of Bond and Lader. Consensus clustering was performed to test the stability of clustering results over samples and over different drug types. Stability analysis was performed using a three-cluster assumption, and then on other alternative assumptions.Heat maps of the consensus matrix (CM) and density plots showed instability of the three-cluster hypothesis and suggested instability over the 3 drug classes. Two- and four-cluster hypothesis were also tested. Heat maps of the CM and density plots suggested that the two-cluster assumption was superior.In summary, the two-cluster assumption leads to a provably stable outcome over samples and the 3 drug types based on the data used.

Consensus for the management of analgesia, sedation and delirium in adults with COVID-19-associated acute respiratory distress syndrome. / Consenso para el manejo de la analgesia, sedación y delirium en adultos con síndrome de distrés respiratorio agudo por COVID-19.

OBJECTIVE: To propose agile strategies for a comprehensive approach to analgesia, sedation, delirium, early mobility and family engagement for patients with COVID-19-associated acute respiratory distress syndrome, considering the high risk of infection among health workers, the humanitarian treatment that we must provide to patients and the inclusion of patients' families, in a context lacking specific therapeutic strategies against the virus globally available to date and a potential lack of health resources. METHODS: A nonsystematic review of the scientific evidence in the main bibliographic databases was carried out, together with national and international clinical experience and judgment. Finally, a consensus of recommendations was made among the members of the Committee for Analgesia, Sedation and Delirium of the Sociedad Argentina de Terapia Intensiva. RESULTS: Recommendations were agreed upon, and tools were developed to ensure a comprehensive approach to analgesia, sedation, delirium, early mobility and family engagement for adult patients with acute respiratory distress syndrome due to COVID-19. DISCUSSION: Given the new order generated in intensive therapies due to the advancing COVID-19 pandemic, we propose to not leave aside the usual good practices but to adapt them to the particular context generated. Our consensus is supported by scientific evidence and national and international experience and will be an attractive consultation tool in intensive therapies.

OBJETIVO: Proponer estrategias agile para este abordaje integral de la analgesia, sedación, delirium, implementación de movilidad temprana e inclusión familiar del paciente con síndrome de dificultad respiratoria aguda por COVID-19, considerando el alto riesgo de infección que existe entre los trabajadores de salud, el tratamiento humanitario que debemos brindar al paciente y su familia, en un contexto de falta estrategias terapéuticas específicas contra el virus globalmente disponibles a la fecha y una potencial falta de recursos sanitarios. METODOS: Se llevó a cabo una revision no sistemática de la evidencia científica en las principales bases de datos bibliográficos, sumada a la experiencia y juicio clínico nacional e internacional. Finalmente, se realizó un consenso de recomendaciones entre los integrantes del Comité de Analgesia, Sedación y Delirium de la Sociedad Argentina de Terapia Intensiva. RESULTADOS: Se acordaron recomendaciones y se desarrollaron herramientas para asegurar un abordaje integral de analgesia, sedación, delirium, implementación de movilidad temprana e inclusión familiar del paciente adulto con síndrome de dificultad respiratoria aguda por COVID-19. DISCUSIÓN: Ante el nuevo orden generado en las terapias intensivas por la progresión de la pandemia de COVID-19, proponemos no dejar atrás las buenas prácticas habituales, sino adaptarlas al contexto particular generado. Nuestro consenso está respaldado en la evidencia científica, la experiencia nacional e internacional, y será una herramienta de consulta atractiva en las terapias intensivas.

Scale Shortening and Decrease in Measurement Precision: Analysis of the Pain Self-Efficacy Questionnaire and Its Short Forms in an Italian-Speaking Population With Neck Pain Disorders.

OBJECTIVE: Short (2- and 4-item) forms of the Pain Self-Efficacy Questionnaire (PSEQ) have been proposed, but their measurement precision at the individual level is unclear.The purpose of this study was to analyze the Rasch psychometric characteristics of PSEQ and its 3 short forms (one 4-item and two 2-item versions) in an Italian-speaking population with neck pain (NP) disorders and compare their measurement precision at the individual level through calculation of the test information function (TIF). METHODS: Secondary analysis of data from a prospective single-group observational study was conducted. In 161 consecutive participants (mean age = 45 years [SD = 14]; 104 women) with NP disorders, a Rasch analysis was performed on each version of the PSEQ (full scale plus 3 short forms), and the TIF was calculated to examine the degree of measurement precision in estimating person ability over the whole measured construct (pain self-efficacy). RESULTS: In all versions of the PSEQ, the rating scale fulfilled the category functioning criteria, and all items showed an adequate fit to the Rasch model. The TIF showed a bell-shaped distribution of information, with an acceptable measurement precision (standard error <0.5) for persons with a wide range of ability; conversely, measurement precision was unacceptably low in each short form (particularly the two 2-item versions). CONCLUSIONS: The results confirm and expand reports on the sound psychometric characteristics of PSEQ, showing for the first time, to our knowledge, its conditional precision in estimating pain self-efficacy measures in Italian individuals with NP disorders. The study cautions against use of the 3 PSEQ short forms for individual-level clinical decision-making. IMPACT: Short scales are popular in rehabilitation settings largely because they can save assessment time and related costs. The psychometric characteristics of the 10-item PSEQ were confirmed and deepened, including its precision in estimating individual pain self-efficacy at different levels of this latent variable. On the other hand, low measurement precision of the 3 PSEQ short forms cautions against their use for individual judgments.

Responsiveness of PROMIS and Patient Health Questionnaire (PHQ) Depression Scales in three clinical trials.

BACKGROUND: The PROMIS depression scales are reliable and valid measures that have extensive normative data in general population samples. However, less is known about how responsive they are to detect change in clinical settings and how their responsiveness compares to legacy measures. The purpose of this study was to assess and compare the responsiveness of the PROMIS and Patient Health Questionnaire (PHQ) depression scales in three separate samples. METHODS: We used data from three clinical trials (two in patients with chronic pain and one in stroke survivors) totaling 651 participants. At both baseline and follow-up, participants completed four PROMIS depression fixed-length scales as well as legacy measures: Patient Health Questionnaire 9-item and 2-item scales (PHQ-9 and PHQ-2) and the SF-36 Mental Health scale. We measured global ratings of depression change, both prospectively and retrospectively, as anchors to classify patients as improved, unchanged, or worsened. Responsiveness was assessed with standardized response means, statistical tests comparing change groups, and area-under-curve analysis. RESULTS: The PROMIS depression and legacy scales had generally comparable responsiveness. Moreover, the four PROMIS depression scales of varying lengths were similarly responsive. In general, measures performed better in detecting depression improvement than depression worsening. For all measures, responsiveness varied based on the study sample and on whether depression improved or worsened. CONCLUSIONS: Both PROMIS and PHQ depression scales are brief public domain measures that are responsive (i.e., sensitive to change) and thus appropriate as outcome measures in research as well as for monitoring treatment in clinical practice. Trial registration ClinicalTrials.gov ID: NCT01236521, NCT01583985, NCT01507688.

King's Parkinson's disease pain scale cut-off points for detection of pain severity levels: A reliability and validity study.

BACKGROUND: Pain is one of the most common non-motor symptoms in Parkinson's disease (PD). Using an appropriate and specific measuring tool would be helpful in managing the pain. King's Parkinson's disease Pain Scale (KPPS) is an instrument designed to specifically measure pain in people with PD. PURPOSE: This study aimed to examine the psychometric properties of the Persian version of KPPS (KPPS-P) and its cut-off points for pain severity levels. METHODS: A total of 480 people with PD (with a mean (SD) age of 60.89 (10.98)) were recruited. The acceptability of KPPS-P was calculated. The structural validity and discriminant validity for different levels of pain was explored via the factor analysis, and Receiver Operating Characteristics (ROC) curves, respectively. Internal consistency, test-retest, and inter-rater reliability were estimated by Cronbach's alpha and Interclass Correlation coefficient (ICC). Convergent validity was established between KPPS-P and other scales including Visual Analog Scale-Pain, Douleur Neuropathic 4, Brief Pain Inventory, Short-form McGill Pain Questionnaire-2, and Parkinson's Disease-8. RESULTS: A significant floor effect was observed. The exploratory factor analysis revealed 4 factors. Cronbach's alpha and ICC values were higher than 0.80. The correlation range between KPPS-P and other scales was 0.35-0.76. Cut-off points of 0, 17, and 68 were obtained to discriminate pain severity levels between no pain, mild, moderate, and severe pain, respectively, with sensitivity and specificity above 0.80. CONCLUSION: Our results indicate that the Persian version of KPPS not only has acceptable psychometric properties to assess pain in PD but also has the ability to distinguish between different levels of pain severity.

Development and Psychometric Evaluation of the PROMIS Pediatric Pain Intensity Measure in Children and Adolescents with Chronic Pain.

The goal of the current study was to enhance the measurement of the pediatric chronic pain experience through a methodologically rigorous approach. This paper outlines the development and initial validation of a pain intensity measure for pediatric patients with chronic pain using Patient-Reported Outcomes Measurement Information System methodology. Measure development incorporated feedback from children with painful conditions. Based on input from pediatric participants and content experts, 4 candidate items assessing pain intensity were included for large scale testing. Children completed self-report items pertaining to their pain experience that were developed as part of a larger pool of new candidate Patient-Reported Outcomes Measurement Information System pediatric pain domain items as well as measures of pain interference, depressive symptoms, fatigue, pain behavior, pain intensity, and pain catastrophizing. The final sample for the large scale testing included N = 442 pediatric patients between the ages 8 to 18 years (Mean age = 13.54, Standard Deviation = 2.78; 71.27% female) experiencing chronic pain. Psychometric analysis resulted in a final measure that included 3 items with evidence of reliability (Cronbach alpha = .82) and convergent validity. The Likert format of the response options may be preferable to the traditional numeric rating scale for use in pediatric populations who experience chronic pain based on patients' feedback, which was directly utilized in designing the scale. Further, the inclusion of fewer and clinically meaningful response options should reduce ambiguity for young respondents. PERSPECTIVE: We have developed and evaluated a clinically sensitive and psychometrically precise 3-item pain intensity measure with Likert-type responses for self-report use among children and adolescents ages 8 to 18 years with chronic pain. Development of the item content and response options included input from children and adolescents with chronic pain. The development of pain intensity items with pediatric appropriate language, and labeled, fewer response options to yield maximal clinically meaningful information improves the precision of pain intensity measurement in children.

The Victorian Institute of Sport Assessment Scale for Patellar Tendinopathy (VISA-P): A Reliability Generalization Meta-analysis.

OBJECTIVE: The Victorian Institute of Sport Assessment-Patella (VISA-P) is a questionnaire to assess the severity of patellar tendinopathies. Its use requires good reliability indicators: internal consistency, test-retest and parallel forms. Several studies have been published examining this question, but to date the reliability of this questionnaire (meta-analysis) has not been generalized. The aim of this study was to perform a meta-analysis to generalize the reliability of the VISA-P. DATA SOURCES: MEDLINE, EMBASE, and Scopus. STUDY SELECTION: Studies included were those examining the reliability coefficients of the VISA-P: Cronbach alpha, intraclass correlation coefficient (ICC), and parallel-forms (correlation coefficients compared with other scales). DATA EXTRACTION: All coefficients were extracted and the mean reliability was obtained using fixed- or random-effects models. Sensitivity (leave-one-out analysis) was analyzed. Quality assessment was performed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. DATA SYNTHESIS: Of 364 scientific articles, 12 fulfilled meta-analysis criteria. The summary statistic was 0.86 [95% confidence interval (CI): 0.78-0.92] for Cronbach alpha and 0.94 (95% CI: 0.89-0.97) for the ICC. Parallel forms depended on the comparative test used, ranging from -0.83 to 0.68. The sensitivity analysis found an influential study for the parallel-forms reliability in the Blazina score. We were unable to analyze the asymmetry of funnel plots and meta-regression models because of the number of studies. CONCLUSIONS: The reliability of VISA-P for assessing the severity of patellar tendinopathies requires greater evaluation with more scientific evidence before it can be implemented in clinical practice.

Measurement Properties of the Oswestry Disability Index in Recipients of Lumbar Spine Surgery.

STUDY DESIGN: This is an observational study on the measurement properties of the Oswestry Disability Index (ODI) version 1.0. OBJECTIVES: To (1) determine the construct validity of the tool, specifically structural validity; (2) analyze the criterion validity of the tool, specifically concurrent validity against proxy measures of pain, function, and quality of life and predictive validity of each item to proxy measures of disability; and (3) reliability of the tool, specifically internal consistency. SUMMARY OF BACKGROUND DATA: We endeavored to investigate the measurement properties of the ODI on a spine surgery population to test the assumption that a more disabled population may influence the properties of the tool. METHODS: Data were pulled from the Quality Outcomes Database (QOD) Spine Registry. A total of 57,199 participants who underwent primary or revision lumbar spine surgeries were included. Structural validity was assessed by exploratory and confirmatory factor analysis, concurrent validity, predictive validity by odds ratios, and internal consistency by Cronbach alpha. The Visual Analog Scale for back pain, two standard open questions, and the EuroQol 5 Dimension/Visual Analogue Scale were included as proxy measures of pain, function, and quality of life, respectively. Hospital readmission, return to operating room for treatment and revision surgery (all within 30 days) were included as proxy measures of disability to assess the predictive validity of each ODI item. RESULTS: The ODI demonstrated a two-factor structural solution, which explained 54.9% of the total variance. Fair internal consistency (0.74-0.77), and fair criterion validity (concurrent) and significant findings with predictive validity (P < 0.01) substantiated the use of each item of the ODI as well as the summary score and ODI thresholds. CONCLUSIONS: Our study lends value to a burgeoning repository of evidence that suggests the ODI is a useful tool for capturing outcomes in clinical practice. We recommend its continued use in clinical practice.Level of Evidence: 4.

Test-Retest Reliability of Pain Measures in Institutionalized Older Adults: Number of Painful Body Sites, Pain Intensity, and Pain Extent.

OBJECTIVE: The reliability of pain assessment in frail and older adults has seldom been assessed. This study aims to assess the test-retest reliability of (1) the number of painful body sites, (2) pain intensity, and (3) pain extent in institutionalized older adults. METHODS: Seventy-four older adults who were institutionalized were assessed in 2 separate sessions, 2 days to 1 week apart, for pain intensity, number of painful body sites, and pain extent (in pixels) using a vertical pain numeric scale (0 to 10), a body chart divided into 50 body regions, and ImageJ, respectively. Intraclass correlation coefficients (ICCs), standard error of measurement (SEM), and minimal detectable differences (MDDs) were calculated. RESULTS: In session 1, the mean values (± standard deviation) were 5.54 ± 2.12 points for pain intensity, 4.47 ± 3.27 for number of painful body sites, and 2,726.00 ± 2,322.09 for pain extent. ICCs were 0.82 (95% confidence interval [CI] = 0.72 to 0.89) for pain intensity, 0.89 (95% CI = 0.83 to 0.93) for number of painful body sites, and 0.74 (95% CI = -0.07 to 0.91) for pain area. The MDDs were 2.46 for pain intensity, 3.14 for number of painful body sites, and 4,997.60 for pain extent. CONCLUSIONS: The vertical pain rating scale and the body chart seem reliable to assess pain intensity and number of pain sites, respectively. The wide CI for the ICC found for pain area and the high measurement error compromise its potential clinical relevance.