Dimensional Assessment of Restricted and Repetitive Behaviors: Development and Preliminary Validation of a New Measure.

OBJECTIVE: This study aimed to provide initial validation of the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB), a new parent-report measure designed to capture the full range of key restricted and repetitive behaviors (RRB) subdomains. METHOD: Parents of 1,892 children and adolescents with autism spectrum disorder (mean [SD] age = 10.81 [4.14] years) recruited from the SPARK (Simons Foundation Powering Autism Research for Knowledge) research match completed the DARB, several existing RRB instruments, and measures of social and communication impairments and anxiety. A subsample of 450 parents completed the DARB after 2 weeks to evaluate the test-retest stability. RESULTS: Exploratory graph analysis conducted in the exploratory subsample identified 8 dimensions that were aligned with hypothesized RRB subdomains: repetitive sensory motor behaviors, insistence on sameness, restricted interests, unusual interests, sensory sensitivity, self-injurious behaviors, obsessions and compulsive behaviors, and repetitive language. The confirmatory application of the exploratory structural equation modeling conducted in the confirmatory subsample showed that the derived factor structure had a good fit to the data. Derived factors had excellent reliability, convergent and divergent validity, and very strong test-retest stability and showed a distinct pattern of associations with key demographic, cognitive and clinical correlates. CONCLUSION: The DARB will be useful in a variety of research and clinical contexts considering the prominence and clinical impact of RRB in autism spectrum disorder. Strong preliminary evidence indicates that the new scale is comprehensive and captures a wide range of distinct RRB subdomains not simultaneously captured by any of the existing instruments.

How Does Triage by an Electronic Symptom Checker Match with Triage by a Nurse?

Omaolo© electronic symptom checkers (ESCs) have been developed to make triage for primary health care patients in Finland. Based on the analysis of the patient's responses to a set of questions, the ESC classifies him/her as emergent, urgent, not urgent, or advices on self-care. In this study the user answered the questions posed by the electronic symptom checker, after which a nurse assessed the urgency of the same user's symptom. The triage nurse was not allowed to know the result of the electronic symptom assessment until he or she had assessed the patient's condition. The level of triage was compared between ESC and nurse in each individual case. Findings from 825 individual cases were analyzed. The mean "exactly matched" for all symptom estimates was 52.6%. The mean "exactly matched" or "overconservative but suitable" for all symptom assessments was 66.6%. Safe assessments of electronic symptom checkers accounted for 98.6% of all assessments. A case was defined as "safe" if the recommendation for action given by the symptom assessment was at most one level less urgent than the nurse's triage assessment of the same case. The findings show that electronic symptom assessments are safe compared to the assessment of an experienced nurse.

European guideline on indications, performance, and clinical impact of hydrogen and methane breath tests in adult and pediatric patients: European Association for Gastroenterology, Endoscopy and Nutrition, European Society of Neurogastroenterology and Motility, and European Society for Paediatric Gastroenterology Hepatology and Nutrition consensus.

INTRODUCTION: Measurement of breath hydrogen (H2 ) and methane (CH4 ) excretion after ingestion of test-carbohydrates is used for different diagnostic purposes. There is a lack of standardization among centers performing these tests and this, together with recent technical developments and evidence from clinical studies, highlight the need for a European guideline. METHODS: This consensus-based clinical practice guideline defines the clinical indications, performance, and interpretation of H2 -CH4 -breath tests in adult and pediatric patients. A balance between scientific evidence and clinical experience was achieved by a Delphi consensus that involved 44 experts from 18 European countries. Eighty eight statements and recommendations were drafted based on a review of the literature. Consensus (≥80% agreement) was reached for 82. Quality of evidence was evaluated using validated criteria. RESULTS: The guideline incorporates new insights into the role of symptom assessment to diagnose carbohydrate (e.g., lactose) intolerances and recommends that breath tests for carbohydrate malabsorption require additional validated concurrent symptom evaluation to establish carbohydrate intolerance. Regarding the use of breath tests for the evaluation of oro-cecal transit time and suspected small bowel bacterial overgrowth, this guideline highlights confounding factors associated with the interpretation of H2 -CH4 -breath tests in these indications and recommends approaches to mitigate these issues. CONCLUSION: This clinical practice guideline should facilitate pan-European harmonization of diagnostic approaches to symptoms and disorders, which are very common in specialist and primary care gastroenterology practice, both in adult and pediatric patients. In addition, it identifies areas of future research needs to clarify diagnostic and therapeutic approaches.

Are we better off using multiple endometriosis classifications in imaging and surgery than settle for one universal less than perfect protocol? Review of staging systems in ultrasound, magnetic resonance and surgery.

There are multiple classifications in imaging and surgery of endometriosis and in this article, we offer a review of the main evaluation systems. The International Deep Endometriosis Analysis group consensus is the leading document for ultrasound assessment, while magnetic resonance imaging is guided by the European Society for Urogenital Radiology recommendations on technical protocol. In surgery, the revised American Society for Reproductive Medicine classification is the oldest system, ideally combined with newer classifications, such as Enzian or Endometriosis Fertility Index. Recently, The World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonisation Project introduced detailed proforma for clinical and intraoperative findings. There is still no universal consensus, so the initial emphasis should be on the uniform reporting of the disease extent until research clarifies more the correlations between extent, symptoms and progression in order to develop a reliable staging system.Impact StatementWhat is already known on this subject? There have been several reviews of surgical classifications, comparing their scope and practical use, while in the imaging the attempts for literature review has been scarce.What do the results of this study add? This is the first up to date review offering detailed analysis of the main classification systems across the three main areas involved in endometriosis care - ultrasound, MRI and surgery. The mutual awareness of the radiological classifications for surgeons and vice versa is crucial in an efficient multidisciplinary communication and patient care. On these comparisons we were able to demonstrate the lack of consensus in description of the extent of the disease and even further lack of prognostic features (with the exemption of one surgical system).What are the implications of these findings for clinical practice and/or further research? Future attempts of scientific societies should focus on defining uniform nomenclature for extent description. In the second step the staging classification should encompass prognostic value (risk of disease and symptoms recurrence).

Validation and clinical value of the MANAGE-PD tool: A clinician-reported tool to identify Parkinson's disease patients inadequately controlled on oral medications.

INTRODUCTION: Making Informed Decisions to Aid Timely Management of Parkinson's Disease (MANAGE-PD) is a clinician-reported tool designed to facilitate timely identification and management of patients with advancing Parkinson's disease (PD) with suboptimal symptom control while on standard therapy. The objective of this study was to evaluate the validity and clinical value of the tool. METHODS: Driven by structured inputs from a steering committee and panel of PD experts, the tool was developed to classify patients into 3 categories. Validity and clinical value were elucidated using a two-pronged approach: (i) hypothetical patient vignettes (n = 10) developed based on the MANAGE-PD tool and rated by 17 PD specialists and 400 general neurologists (GN) and (ii) patients with PD (n = 2546) managed in real-world clinical settings. Vignette validity was based on concordance between PD experts' clinical judgement and MANAGE-PD vignette categorization. Patient-level data was used for known-group comparisons (validity) and discordant pair analysis (clinical value). RESULTS: The tool demonstrated strong validity and clinical value among PD specialists (intraclass coefficient [ICC] 0.843; Fleiss weighted kappa [ƙweighted] 0.79) and GN (ICC 0.690; ƙweighted 0.65) using patient vignettes. MANAGE-PD also demonstrated real-world validity and clinical value based on ability to identify patients with incrementally higher clinical, economic, and humanistic PD burden across categories of the tool (p < 0.01). CONCLUSIONS: MANAGE-PD demonstrated robust validity and clinical value in identifying patients with suboptimal PD symptom control. Clinical use of MANAGE-PD may complement treatment decision-making and facilitate timely and comprehensive management of patients with advancing PD.

Diagnostic criteria for blepharospasm: A multicenter international study.

BACKGROUND: There are no widely accepted criteria to aid the physician in diagnosing BSP. OBJECTIVE: To validate recently proposed diagnostic criteria for blepharospasm in a larger and geographically diverse population and to develop a screening system for blepharospasm. METHODS: Video-recordings from 211 blepharospasm patients and 166 healthy/disease controls were examined by 8 raters. Agreement for presence of orbicularis oculi spasms, sensory trick, and increased blinking was measured by k statistics. Inability to voluntarily suppress the spasms was asked by the examiner but not captured in the video. Patients/controls were also requested to fill a self-administered questionnaire addressing relevant blepharospasm clinical aspects. The diagnosis at each site was the gold standard for sensitivity/specificity. RESULTS: All the study items yielded satisfactory inter/intra-observer agreement. Combination of items rather than each item alone reached satisfactory sensitivity/specificity. The combined algorithm started with recognition of spasms followed by sensory trick. In the absence of a sensory trick, including "increased blinking" or "inability to voluntarily suppress the spasms" or both items yielded 88-92% sensitivity and 79-83% specificity. No single question of the questionnaire yielded high sensitivity/specificity. Serial application of the questionnaire to our blepharospasm and control subjects and subsequent clinical examination of subjects screening positive by the validated diagnostic algorithms yielded 78-81% sensitivity and 83-91% specificity. CONCLUSION: These results support the use of proposed diagnostic criteria in multi-ethnic, multi-center cohorts. We also propose a case-finding procedure to screen blepharospasm in a given population with less effort than would be required by examination of all subjects.

Drooling rating scales in Parkinson's disease: A systematic review.

BACKGROUND: Drooling is a clinically relevant non-motor symptom of people with Parkinson's disease (PwP). Several drooling rating scales are available. Nevertheless, the compelling scientific evidence supporting their validity is limited. This study aims to evaluate clinical rating scales for drooling, assessing their characteristics, clinimetric properties, and clinical utility classification. METHODS: A systematic review was undertaken. Two reviewers performed independent literature searches using the CENTRAL®, CINAHL®, Embase®, MEDLINE®, SciElo®, and SPEECH BITE® databases. We used consensus-based standards for the selection of health measurement instruments (COSMIN) and the International Parkinson's disease and the Movement Disorders (MDS) criteria to evaluate the included rating scales. RESULTS: The following six rating scales were identified: Drooling Impact Scale (DIS), Sialorrhea Scoring Scale (SSS), Drooling Severity and Frequency Scale (DSFS), Drooling Rating Scale (DRS), Sialorrhea Clinical Scale for Parkinson Disease (SCS-PD), and the Radboud Oral Motor inventory for Parkinson's disease - Saliva (ROMP-saliva). The scales had heterogeneous characteristics: (i) not all were created/adapted for PwP; (ii) different dimensions associated with drooling are assessed; (iii) cross-cultural adaptations are limited to some languages. The clinimetric properties showed: (i) target population size limitations; (ii) incomplete reliability analysis; (iii) lack of robust validity; (iv) sensitivity to change not fully explored. Following the MDS criteria, only one tool was classified as "recommended", the ROMP-saliva. CONCLUSIONS: This review provides information for an adequate selection of a drooling rating scale for clinical and/or research purposes. To date, ROMP-saliva is the only scale with substantial evidence of its clinimetric properties adequacy and data in PwP.

Optimal NIV Medicare Access Promotion: Patients With OSA: A Technical Expert Panel Report From the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society.

This document summarizes the work of the CPAP and bilevel PAP therapy for OSA Technical Expert Panel working group. For positive airway pressure (PAP) therapy, the most pressing current coverage barriers identified were: an insufficient symptom list describing all potential symptoms in patients with mild OSA; the 4 h per night of PAP usage requirement to keep the device; the additional sleep studies requirement to re-qualify for PAP or supplemental oxygen; and the inability to use telehealth visits for follow-up visits. Critical evidence supports changes to current policies and includes: symptom list inadequate to cover all scenarios based on updated clinical practice guidelines; published evidence that 2 h per night of PAP use can result in benefit to quality of life and other metrics; the costs of another sleep study not justified for all nonadherent patients or for supplemental oxygen due to other types of assessment currently available; and the remarkable success and acceptance of telehealth visits. To achieve optimal access for patients on PAP therapy, we make the following key suggestions: removing symptom criteria for mild OSA; reduce continued coverage criteria to > 2 h per night; eliminate the need for a sleep study to re-qualify if nonadherent or for new Centers for Medicare & Medicaid Services beneficiaries already on and adherent to PAP therapy; allow telehealth visits for documenting benefit and adherence; and allow PAP reports and domiciliary oximetry to qualify for supplemental oxygen with PAP if needed. This paper shares our best vision for bringing the right device to the right patient at the right time.

A systematic review of cross-cultural adaptation of the National Institutes of Health Chronic Prostatitis Symptom Index.

BACKGROUND: The National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) was developed to accurately assess the pain, urinary symptoms, and quality of life related to chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). This study aimed to evaluate the cross-cultural adaptations of the NIH-CPSI. METHOD: PubMed, Embase, CINAHL, and SciELO databases were searched from their established year to September 2020. Cross-cultural adaptations and the quality control of measurement properties of adaptations were conducted by two reviewers independently according to the Guidelines for the Process of Cross-Cultural Adaptation of Self-Report Measures and the Quality Criteria for Psychometric Properties of Health Status Questionnaire. RESULTS: Area total of 21 papers with 16 adaptations, and six studies of the original version of the NIH-CPSI were enrolled in the systematic review. Back translation was the weakest process for the quality assessment of the cross-cultural adaptations of the NIH-CPSI. Internal consistency was analyzed for most of the adaptations, but none of them met the standard. Only 11 adaptations reported test reliability, then only the Arabic-Egyptian, Chinese-Mainland, Danish, Italian, Persian, and Turkish adaptations met the criterion. Most adaptations reported the interpretability, but only the Danish adaptation reported the agreement. The other measurement properties, including responsiveness, and floor as well as ceiling effects were not reported in any of the adaptations. CONCLUSIONS: The overall quality of the NIH-CPSI cross-cultural adaptations was not organized as expected. Only the Portuguese-Brazilian, Italian, and Spanish adaptations reached over half the process for the cross-cultural adaptation. Only the Turkish adaptations finished half of the measurement properties of cross-cultural adaptations.

Measurement properties of the 12-item Short Form Health Survey version 2 in Australians with lung cancer: a Rasch analysis.

BACKGROUND: The 12-item Short-Form Health Survey version 2 (SF-12v2), a widely used, generic patient-reported measure of health status that provides summary scores of physical and mental health. No study to date has examined the measurement properties of the SF-12v2 in patients with lung cancer using Rasch analysis. The aim of this study was to extend the psychometric evaluations of the SF-12 within the lung cancer population to ensure its validity and reliability to assess the health status in this population. METHODS: Participants in the Victorian Lung Cancer Registry (VLCR) who completed the SF-12v2 between 2012 and 2016 were included in this study. The structural validity of the SF-12v2 was assessed using Rasch analysis. Overall fit to the Rasch measurement model was examined as well as five key measurement properties: uni-dimensionality, response thresholds, internal consistency, measurement invariance and targeting. RESULTS: A total of 342 participants completed the SF-12v2 three months following their lung cancer diagnosis. The SF-12 Physical Component Score (PCS-12) did not fit the overall Rasch measurement model (χ2 107.0; p < 0.001). Three items deviated significantly from the Rasch model (item fit residual beyond ± 2.5) with signs of dependency between item responses and disordered thresholds. Nevertheless, the PCS-12 was uni-dimensional with good internal consistency (person separation index [PSI] 0.83) and reasonable targeting. In contrast, the SF-12 Mental Component Score (MCS-12) had good overall model fit (χ2 35.1; p = 0.07), reasonable targeting and good internal consistency (PSI 0.81). CONCLUSIONS: Rasch analysis suggests that there is general support for the reliability of the SF-12v2 as a measure of physical and mental health in people with lung cancer. However, the appropriateness of some items (e.g. pain) in the PCS-12 is questionable and further refinement of the scale including changing the response options may be required to improve the ability of the SF-12v2 to more appropriately assess the health status of this population.

Development of the gait outcomes assessment list for lower-limb differences (GOAL-LD) questionnaire: a child and parent reported outcome measure.

BACKGROUND: To develop a priority-based patient/parent reported outcome measure for children with lower-limb differences (LD) by adapting the Gait Outcomes Assessment List (GOAL) questionnaire. METHODS: Guided by a conceptual framework of patient priorities, the GOAL questionnaire was iteratively modified and its sensibility evaluated by field-testing it on children with LD, and their parents. Cognitive interviews were conducted with a subgroup of these children, and an e-survey administered to a multidisciplinary group of health care professionals with expertise in paediatric LD. Findings were integrated to create the final version of the GOAL-LD. RESULTS: Twenty-five children (9-18 years), 20 parents, and 31 healthcare professionals evaluated the content and sensibility of the GOAL, with an emphasis on the relevance and importance of the items to patients' health related quality of life (HRQL). This resulted in the retention of 26 of the original 50 items, elimination of 12, modification of 12, and addition of seven new items. The new 45-item GOAL-LD questionnaire was shown to be sensible, and its content deemed important. CONCLUSIONS: The GOAL-LD questionnaire has a high level of face and content validity, and sensibility. It comprehensively captures the HRQL goals and outcomes that matter to children with LD and their parents. Following further psychometric evaluation, the GOAL-LD may serve as a much needed patient and parent reported outcome measure for this population.

Validation and clinical evaluation of a Polish translation of the Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K).

BACKGROUND: The Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) is a self-administered questionnaire developed to evaluate the severity of the common cold. It is a patient-oriented instrument that evaluates quality of life in an illness-specific manner to be used in children aged 10 years. The purpose of this study was to validate the Polish version of the Wisconsin Upper Respiratory Symptom Survey for Kids. METHODS: The validation process consisted of five stages: forward translation, backward translation, cognitive debriefing, a pilot study (Study A and Study B), and statistical analysis. The first study (Study A, n = 10, aged 5-13) was conducted in the Emergency Room and an Outpatient Clinic of the Pediatric University Hospital in Warsaw. The purpose of the study was to obtain data for testing the convergent validity of the questionnaire. The second study (Study B, n = 56), consisted of children aged four to six enrolled in three kindergartens in the Warsaw suburbs. The obtained data were subjected to detailed statistical analysis. RESULTS: The WURSS Kids Polish showed excellent reliability. The Cronbach's alpha of the 13 items was 0.791 for the six symptom items and 0.854 for the seven functional items. The Jonckheere-Terpstra trend test was used to evaluate criterion validity. Compliance of the measurement performed independently by the examined person and the doctor on the first day was high (convergent validity). Each particular item was characterized by a different sensitivity to clinical change. The Guyatt's Responsiveness index ranged from 0.083 to 0.464. CONCLUSION: The internal consistency of the measurements and cross-cultural adaptation of the Polish version of WURSS Kids was satisfactory. The WURSS Kids Polish is a reliable, valid, and responsive disease-specific questionnaire for assessing symptoms and QOL in Polish patients in the pediatric population with the common cold. It may be used both in clinical practice and for research among Polish children with URTI.

Reliability and Validity Testing of the Quantified Quality of Interaction Schedule.

BACKGROUND AND PURPOSE: The purpose of this study was to test the reliability and validity of the Quality of Interactions Schedule (QuIS) using a quantification scoring approach. METHODS: Baseline data from the Evidence Integration Triangle for Behavioral and Psychological Symptoms of Dementia (EIT-4-BPSD) study was used. RESULTS: A total of 553 residents participated. There was evidence of inter-rater reliability with Kappa scores of .86 to 1.00 and internal consistency based on the Rasch analysis (item reliability of .98). There was some support for validity based on item fit and hypothesis testing as resistiveness to care was significantly associated with total QuIS scores. CONCLUSION: This study supports the use of the quantified QuIS to evaluate the quality of interactions over time and to test interventions to improve interactions.

Validation of an 8-item Recovery Assessment Scale (RAS-8) for people with schizophrenia in China.

BACKGROUND: The 24-item Recovery Assessment Scale (RAS) is the most widely-used and well-validated tool for measuring recovery for people with mental illness. The current study aims to assess the reliability and validity of an 8-item short form of RAS (RAS-8) among a Chinese sample of people living with schizophrenia. METHODS: A sample of 400 people living with schizophrenia were recruited for scale validation. Internal consistency was tested by calculating Cronbach's α. Test-retest reliability was calculated using the intraclass correlation coefficient (ICC) for the total score and weighted kappa for each item. Factor structure was tested with confirmatory factor analysis, and concurrent validity was examined by investigating the correlation of the RAS-8 with patient symptoms, disability, depression, anxiety, patient functioning, quality of life and general health. RESULTS: The RAS-8 full scale and subscales showed good internal consistency with Cronbach's alpha ranging from 0.87 to 0.92. ICC of 0.99 and weighted kappa ranged from 0.62 to 0.88, which generally indicates good test-retest reliability. The findings supported an a priori two-factor structure, χ2/df = 2.93, CFI = 0.98, TLI = 0.98, RMSEA = 0.07, SRMR = 0.035. Concurrent validity of the RAS-8 was further supported by its significant negative correlations with patient symptoms (r = -0.24, p < 0.01), disability (r = -0.30, p < 0.01), depression (r = -0.16, p < 0.05), and anxiety (r = -0.14, p < 0.05), and its significant positive relationships with patient functioning (r = 0.26, p < 0.01), quality of life (r = 0.39, p < 0.01) and general health (r = 0.34, p < 0.01). CONCLUSIONS: This study confirmed the reliability and validity of an 8-item short-form RAS for people living with schizophrenia in Chinese communities. The validation of the RAS-8 allows for its use as an alternative for the full RAS as a rapid assessment tool in clinical and research settings. The findings are discussed for their implications for application and validation with other populations and in other countries.

Expert Perspective: Management of Refractory Inflammatory Myopathy.

The idiopathic inflammatory myopathies (IIMs) are chronic disorders characterized by inflammation in skeletal muscle but also in other organs such as the skin, lungs, joints, gastrointestinal tract, and heart. The effect of immunosuppressive treatment varies between individual patients and between organ manifestations within the same individual. Many patients respond poorly to first-line treatment with glucocorticoids and other immunosuppressive agents such as methotrexate or azathioprine, with symptoms persisting in the muscles, skin, and lungs, leading to refractory disease. Management of refractory IIM is a clinical challenge, and a systematic approach is proposed to better understand the lack of treatment response, in order to guide disease management. The first step in the management of refractory IIM is to recognize whether remaining symptoms are caused by persistent inflammation in the affected tissue or whether the symptoms may be attributable to damage preceding inflammation. Thus, a second diagnostic examination is recommended. Second, in particular for patients with remaining muscle weakness, it is important to ascertain whether the diagnosis of myositis is correct or whether another underlying muscle disorder could explain the symptoms. Third, with confirmation of remaining inflammation in the tissues, a strategy to change treatment needs to be undertaken. Few controlled trials are available to guide our treatment strategies. Furthermore, different subgroups of patients may benefit from different therapies, and different organ manifestations may respond to different therapies. In this context, subgrouping of patients with IIM based on autoantibody profile may be helpful, as there are emerging data from open studies and case series to support the notion of a varying treatment response in different autoantibody-defined subgroups of IIM patients.

The PCOC Symptom Assessment Scale (SAS): A valid measure for daily use at point of care and in palliative care programs.

BACKGROUND: Very few measures are used successfully as part of routine care within national palliative care outcome programs. Only a handful of studies examine these measures. The aim of this study is to evaluate the validity of a measure used in a national outcomes program: the Palliative Care Outcomes Collaboration Symptom Assessment Scale (PCOC SAS). METHODS: A retrospective multi-site cohort study with secondary analysis of routinely collected patient-level data to assess PCOC SAS's internal consistency, construct validity, reliability, interpretability, acceptability and sensitivity. The analyses used two sets, with data collected by inpatient and community palliative care services registered with the Australian national PCOC. RESULTS: Dataset one included 1,117 patients receiving palliative care from 21 services. Dataset two included 5,294 patients receiving palliative care from 119 PCOC services. PCOC SAS demonstrated the ability to detect and discriminate distress by palliative care phase, functional status and diagnosis. Excellent and good convergent and discriminant validity were demonstrated. Fair through to substantial inter-rater and intra-rater reliability levels were evidenced. Sufficient interpretability resulted along with necessary levels of acceptability and sensitivity. CONCLUSION: PCOC SAS is a valid and reliable patient-reported outcome measure suitable for use in routine clinical care with patients requiring palliative and or end-of-life care, including in national outcomes programs.