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Sample records for reported outcome questionnaires

  1. The OnyCOE-t™ questionnaire: responsiveness and clinical meaningfulness of a patient-reported outcomes questionnaire for toenail onychomycosis

    PubMed Central

    Potter, Lori P; Mathias, Susan D; Raut, Monika; Kianifard, Farid; Tavakkol, Amir

    2006-01-01

    Background This research was conducted to confirm the validity and reliability and to assess the responsiveness and clinical meaningfulness of the OnyCOE-t™, a questionnaire specifically designed to measure patient-reported outcomes (PRO) associated with toenail onychomycosis. Methods 504 patients with toenail onychomycosis randomized to receive 12 weeks of terbinafine 250 mg/day with or without target toenail debridement in the IRON-CLAD® trial completed the OnyCOE-t™ at baseline, weeks 6, 12, 24, and 48. The OnyCOE-t™ is composed of 6 multi-item scales and 1 single-item scale. These include a 7-item Toenail Symptom assessment, which comprises both Symptom Frequency and Symptom Bothersomeness scales; an 8-item Appearance Problems scale; a 7-item Physical Activities Problems scale; a 1-item Overall Problem scale; a 7-item Stigma scale; and a 3-item Treatment Satisfaction scale. In total, 33 toenail onychomycosis-specific items are included in the OnyCOE-t™. Clinical data, in particular the percent clearing of mycotic involvement in the target toenail, and OnyCOE-t™ responses were used to evaluate the questionnaire's reliability, validity, responsiveness, and the minimally clinical important difference (MCID). Results The OnyCOE-t™ was shown to be reliable and valid. Construct validity and known groups validity were acceptable. Internal consistency reliability of multi-item scales was demonstrated by Cronbach's alpha > .84. Responsiveness was good, with the Treatment Satisfaction, Symptom Frequency, Overall Problem, and Appearance Problem scales demonstrating the most responsiveness (Guyatt's statistic of 1.72, 1.31, 1.13, and 1.11, respectively). MCID was evaluated for three different clinical measures, and indicated that approximately an 8.5-point change (on a 0 to 100 scale) was clinically meaningful based on a 25% improvement in target nail clearing. Conclusion The OnyCOE-t™ questionnaire is a unique, toenail-specific PRO questionnaire that can be

  2. Mental health and adjustment to juvenile idiopathic arthritis: Level of agreement between parent and adolescent reports according to Strengths and Difficulties Questionnaire and Adolescent Outcomes Questionnaire

    PubMed Central

    Adamczyk, Katarzyna A.; Niedziela, Marek; Głowacki, Maciej; Głowacki, Jakub

    2017-01-01

    The aims of this study were threefold. Firstly, to analyze the psychometric properties of the Polish-language Pediatric Outcomes Data Collection Instrument (PODCI) questionnaire in the self-report Adolescent Outcomes Questionnaire (adolescents, 11–18 years of age) and in the parent-report Adolescent Outcomes Questionnaire (completed by a parent or guardian of an adolescent aged 11–18 years). Secondly, to determine the level of agreement between parents and adolescents in rating dysfunction in juvenile idiopathic arthritis (JIA) and thirdly, to examine associations between psychological adjustments of patients to JIA and disease as well as their socio-demographic characteristics. The study sample consisted of 52 participants. 26 adolescents between the ages of 11 and 18 years with a diagnosis of JIA and 26 parents were considered for inclusion. Disease course was classified as pauciarticular (n = 12, 46.2%) and polyarticular (n = 14, 53.8%). Participants completed the PODCI (self- and parent- report) twice and the Strengths and Difficulties Questionnaire-25 (SDQ-25). Considering the distribution of results regarding PODCI normative scores, 73.1% of parents and 69.2% of patients scored below 50 on the Global Functioning Scale; that is lower than the average for the general healthy population. Regarding the parent report, the total score of the SDQ-25 equaled 11.86 (SD 2.66), whereas the patient report equaled 11.23 (SD 2.78). The study groups do not differ significantly in regards to either the PODCI or the SDQ-25 results. Parents and adolescents with JIA appear to hold very similar perceptions of patients' health. Greater differences emerge as disease severity and age of patients increase. Excellent internal consistency, intrarater and test-retest reliability of the Global Functioning Scale have been confirmed in the Polish version of the PODCI, the questionnaire may therefore aid identification of patients reporting significant problems in this group. PMID

  3. Towards Tailored Patient's Management Approach: Integrating the Modified 2010 ACR Criteria for Fibromyalgia in Multidimensional Patient Reported Outcome Measures Questionnaire.

    PubMed

    El Miedany, Yasser; El Gaafary, Maha; Youssef, Sally; Ahmed, Ihab

    2016-01-01

    Objectives. To assess the validity, reliability, and responsiveness to change of a patient self-reported questionnaire combining the Widespread Pain Index and the Symptom Severity Score as well as construct outcome measures and comorbidities assessment in fibromyalgia patients. Methods. The PROMs-FM was conceptualized based on frameworks used by the WHO Quality of Life tool and the PROMIS. Initially, cognitive interviews were conducted to identify item pool of questions. Item selection and reduction were achieved based on patients as well as an interdisciplinary group of specialists. Rasch and internal consistency reliability analyses were implemented. The questionnaire included the modified ACR criteria main items (Symptom Severity Score and Widespread Pain Index), in addition to assessment of functional disability, quality of life (QoL), review of the systems, and comorbidities. Every patient completed HAQ and EQ-5D questionnaires. Results. A total of 146 fibromyalgia patients completed the questionnaire. The PROMs-FM questionnaire was reliable as demonstrated by a high standardized alpha (0.886-0.982). Content construct assessment of the functional disability and QoL revealed significant correlation (p < 0.01) with both HAQ and EQ-5D. Changes in functional disability and QoL showed significant (p < 0.01) variation with diseases activity status in response to therapy. There was higher prevalence of autonomic symptoms, CVS risk, sexual dysfunction, and falling. Conclusions. The developed PROMs-FM questionnaire is a reliable and valid instrument for assessment of fibromyalgia patients. A phased treatment regimen depending on the severity of FMS as well as preferences and comorbidities of the patient is the best approach to tailored patient management.

  4. Towards Tailored Patient's Management Approach: Integrating the Modified 2010 ACR Criteria for Fibromyalgia in Multidimensional Patient Reported Outcome Measures Questionnaire

    PubMed Central

    El Miedany, Yasser; El Gaafary, Maha; Youssef, Sally; Ahmed, Ihab

    2016-01-01

    Objectives. To assess the validity, reliability, and responsiveness to change of a patient self-reported questionnaire combining the Widespread Pain Index and the Symptom Severity Score as well as construct outcome measures and comorbidities assessment in fibromyalgia patients. Methods. The PROMs-FM was conceptualized based on frameworks used by the WHO Quality of Life tool and the PROMIS. Initially, cognitive interviews were conducted to identify item pool of questions. Item selection and reduction were achieved based on patients as well as an interdisciplinary group of specialists. Rasch and internal consistency reliability analyses were implemented. The questionnaire included the modified ACR criteria main items (Symptom Severity Score and Widespread Pain Index), in addition to assessment of functional disability, quality of life (QoL), review of the systems, and comorbidities. Every patient completed HAQ and EQ-5D questionnaires. Results. A total of 146 fibromyalgia patients completed the questionnaire. The PROMs-FM questionnaire was reliable as demonstrated by a high standardized alpha (0.886–0.982). Content construct assessment of the functional disability and QoL revealed significant correlation (p < 0.01) with both HAQ and EQ-5D. Changes in functional disability and QoL showed significant (p < 0.01) variation with diseases activity status in response to therapy. There was higher prevalence of autonomic symptoms, CVS risk, sexual dysfunction, and falling. Conclusions. The developed PROMs-FM questionnaire is a reliable and valid instrument for assessment of fibromyalgia patients. A phased treatment regimen depending on the severity of FMS as well as preferences and comorbidities of the patient is the best approach to tailored patient management. PMID:27190648

  5. Response Rates for Patient-Reported Outcomes Using Web-Based Versus Paper Questionnaires: Comparison of Two Invitational Methods in Older Colorectal Cancer Patients

    PubMed Central

    Vissers, Pauline AJ; Mols, Floortje; Thong, Melissa SY; van de Poll-Franse, Lonneke V

    2015-01-01

    Background Improving questionnaire response rates is an everlasting issue for research. Today, the Internet can easily be used to collect data quickly. However, collecting data on the Internet can lead to biased samples because not everyone is able to access or use the Internet. The older population, for example, is much less likely to use the Internet. The Patient-Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship (PROFILES) registry offers a platform to collect Web-based and paper questionnaires and to try different measures to improve response rates. Objective In this study, our aim was to study the influence of two methods of invitation on the response rate. Our second aim was to examine the preference of questionnaire mode of administration (paper or Web-based) for the older patient in particular. Methods To test these two invitational methods, 3406 colorectal cancer patients between ages 18 and 85 years received an invitation containing an access code for the Web-based questionnaire. They could also request a paper questionnaire with an included reply card (paper-optional group). In contrast, 179 randomly selected colorectal cancer patients received a paper questionnaire with the invitation (paper-included group). They could also choose to fill out the Web-based questionnaire with the included access code. Results Response rates did not differ between the paper-optional and the paper-included groups (73.14%, 2491/3406 and 74.9%, 134/179, P=.57). In the paper-optional group, online response was significantly higher when compared to the paper-included group (41.23%, 1027/2491 vs 12.7%, 17/134, P<.001). The majority of online respondents responded after the first invitation (95.33%, 979/1027), which was significantly higher than the paper respondents (52.19%, 764/1464, P<.001). Respondents aged 70 years and older chose to fill out a paper questionnaire more often (71.0%, 677/954). In the oldest age group (≥80 years), 18

  6. Change Trajectories for the Youth Outcome Questionnaire Self-Report: Identifying Youth at Risk for Treatment Failure

    ERIC Educational Resources Information Center

    Cannon, Jennifer A. N.; Warren, Jared S.; Nelson, Philip L.; Burlingame, Gary M.

    2010-01-01

    This study used longitudinal youth outcome data in routine mental health services to test a system for identifying cases at risk for treatment failure. Participants were 2,715 youth (M age = 14) served in outpatient managed care and community mental health settings. Change trajectories were developed using multilevel modeling of archival data.…

  7. Patient-Reported Outcomes Following Breast Reconstruction Surgery and Therapeutic Mammoplasty: Prospective Evaluation 1 Year Post-Surgery with BREAST-Q Questionnaire.

    PubMed

    Shekhawat, Laxmi; Busheri, Laleh; Dixit, Santosh; Patel, Chaula; Dhar, Upendra; Koppiker, Chaitanyanand

    2015-12-01

    Breast Cancer (BC) treatment leads to mutilation and destruction of breast shape with negative effects on body image and self-esteem.One of the main goals of reconstructive and oncoplastic breast surgery is to satisfy patients and improve their quality of life (QoL).Therefore, it is important to assess the patient experience post-surgery by means of patient-reported outcome measures (PROMs) that focus on the patient's perception of the surgery and surgical care, as well as psychosocial well-being and physical functioning. The objective of the current study was to identify predictors of patient satisfaction such as breast appearance including implant type in a selective sample of women who underwent breast reconstruction surgery using implants. Participants in this prospective study were women, (age 26-75 years) that were newly diagnosed with breast carcinoma. All consecutive patients who underwent breast reconstruction between January 2013 and October 2014 were asked to complete the BREAST-Q questionnaire 1 year after surgery. 120 patients underwent unilateral breast reconstruction using implant. While 38 patients underwent reconstruction with opposite breast reduction symmertization, 27 patients underwent therapeutic mammoplasty. The response rate for BREAST-Q questionnaire completion was 98 % with 147 out of 150 study participants completed the questionnaire. From the data collected from 147 patients, the responses could be distributed into 4 distinct groups based on the reconstruction outcomes namely "very much satisfied" (93 %) or "definitely and mostly satisfied" (94 %) or "satisfied" with the outcome (88 %) or "definitely agree on having reconstruction rather than the alternative of having no breast "(91 %).The results showed significant improvement in all four areas that were evaluated after surgery namely satisfaction with the appearance of the breasts, psychosocial, sexual and physical well-being. While the reconstruction surgery had an overall

  8. Detecting Careless Responses to Self-Reported Questionnaires

    ERIC Educational Resources Information Center

    Kountur, Ronny

    2016-01-01

    Problem Statement: The use of self-report questionnaires may lead to biases such as careless responses that distort the research outcomes. Early detection of careless responses in self-report questionnaires may reduce error, but little guidance exists in the literature regarding techniques for detecting such careless or random responses in…

  9. Self-reported defence mechanisms as an outcome measure in psychotherapy: a study on the German version of the Defence Style Questionnaire DSQ 40.

    PubMed

    Schauenburg, Henning; Willenborg, Verena; Sammet, Isa; Ehrenthal, Johannes C

    2007-09-01

    The psychoanalytically informed construct of 'defence mechanisms' is of central importance for the understanding of the dynamics of inner conflicts and the onset of neurotic symptoms. Objective and valid assessment of 'defence' is difficult. There are a number of observer rating instruments but only few self-report questionnaires. The German version of the 'Defence Style Questionnaire - DSQ 40' (Andrews, Singh, & Bond, 1993) was examined with regard to its factorial and content validity, and its sensitivity to change during inpatient psychotherapy. One hundred and fifty-five patients with mixed diagnoses were administered the DSQ 40 and the SCL-90-R before and after 3 months of inpatient psychotherapy. Diagnoses were mostly affective and anxiety disorders as well as eating disorders, and there was a high comorbidity of personality disorders. After deletion of some items due to insufficient pairwise item-intercorrelation or false classification to a defence mechanism by experienced clinicians, we found three stable factors of defence (maladaptive, intermediate-neurotic and adaptive) consistent with the previous research. After 3 months of therapy, a decrease in maladaptive mechanisms and an increase in adaptive patterns were found, while neurotic mechanisms did not change on average. Our shortened version of the DSQ 40 was shown to be a valid instrument for the assessment of defence mechanisms and change in these mechanisms after psychotherapy. Our design did not permit an assessment of whether or not the change in defence mechanisms was due to the therapeutic treatment.

  10. Further Evaluation of the Outcome Questionnaire-45.2

    ERIC Educational Resources Information Center

    Rice, Kenneth G.; Suh, Hanna; Ege, Engin

    2014-01-01

    Data from clinical and nonclinical samples ("Ns" = 2,096, 618) were used to evaluate and replicate the measurement structure of the Outcome Questionnaire-45.2. Different measurement models and invariance tests were evaluated and the best psychometric support was found for a shortened measure of two factors: overall maladjustment and…

  11. The Brief Symptom Inventory and the Outcome Questionnaire-45 in the Assessment of the Outcome Quality of Mental Health Interventions

    PubMed Central

    Schuetz, Christopher; Andreae, Andreas; Koemeda, Margit; Schulthess, Peter; Tschuschke, Volker; von Wyl, Agnes

    2016-01-01

    Self-report questionnaires are economical instruments for routine outcome assessment. In this study, the performance of the German version of the Outcome Questionnaire-45 (OQ-45) and the Brief Symptom Inventory (BSI) was evaluated when applied in analysis of the outcome quality of psychiatric and psychotherapeutic interventions. Pre-post data from two inpatient samples (N = 5711) and one outpatient sample (N = 239) were analyzed. Critical differences (reliable change index) and cut-off points between functional and dysfunctional populations were calculated using the Jacobson and Truax method of calculating clinical significance. Overall, the results indicated that the BSI was more accurate than the OQ-45 in correctly classifying patients as clinical subjects. Nonetheless, even with the BSI, about 25% of inpatients with schizophrenia attained a score at admission below the clinical cut-off. Both questionnaires exhibited the highest sensitivity to psychopathology with patients with personality disorders. When considering the differences in the prescores, both questionnaires showed the same sensitivity to change. The advantage of using these self-report measures is observed primarily in assessing outpatient psychotherapy outcome. In an inpatient setting two main problems—namely, the low response rate and the scarce sensitivity to psychopathology with severely ill patients—limit the usability of self-report questionnaires. PMID:27699166

  12. Usability of a barcode scanning system as a means of data entry on a PDA for self-report health outcome questionnaires: a pilot study in individuals over 60 years of age

    PubMed Central

    Boissy, Patrick; Jacobs, Karen; Roy, Serge H

    2006-01-01

    Background Throughout the medical and paramedical professions, self-report health status questionnaires are used to gather patient-reported outcome measures. The objective of this pilot study was to evaluate in individuals over 60 years of age the usability of a PDA-based barcode scanning system with a text-to-speech synthesizer to collect data electronically from self-report health outcome questionnaires. Methods Usability of the system was tested on a sample of 24 community-living older adults (7 men, 17 women) ranging in age from 63 to 93 years. After receiving a brief demonstration on the use of the barcode scanner, participants were randomly assigned to complete two sets of 16 questions using the bar code wand scanner for one set and a pen for the other. Usability was assessed using directed interviews with a usability questionnaire and performance-based metrics (task times, errors, sources of errors). Results Overall, participants found barcode scanning easy to learn, easy to use, and pleasant. Participants were marginally faster in completing the 16 survey questions when using pen entry (20/24 participants). The mean response time with the barcode scanner was 31 seconds longer than traditional pen entry for a subset of 16 questions (p = 0.001). The responsiveness of the scanning system, expressed as first scan success rate, was less than perfect, with approximately one-third of first scans requiring a rescan to successfully capture the data entry. The responsiveness of the system can be explained by a combination of factors such as the location of the scanning errors, the type of barcode used as an answer field in the paper version, and the optical characteristics of the barcode scanner. Conclusion The results presented in this study offer insights regarding the feasibility, usability and effectiveness of using a barcode scanner with older adults as an electronic data entry method on a PDA. While participants in this study found their experience with the

  13. Measuring the Effects of Self-Awareness: Construction of the Self-Awareness Outcomes Questionnaire

    PubMed Central

    Sutton, Anna

    2016-01-01

    Dispositional self-awareness is conceptualized in several different ways, including insight, reflection, rumination and mindfulness, with the latter in particular attracting extensive attention in recent research. While self-awareness is generally associated with positive psychological well-being, these different conceptualizations are also each associated with a range of unique outcomes. This two part, mixed methods study aimed to advance understanding of dispositional self-awareness by developing a questionnaire to measure its outcomes. In Study 1, expert focus groups categorized and extended an initial pool of potential items from previous research. In Study 2, these items were reduced to a 38 item self-report questionnaire with four factors representing three beneficial outcomes (reflective self-development, acceptance and proactivity) and one negative outcome (costs). Regression of these outcomes against self-awareness measures revealed that self-reflection and insight predicted beneficial outcomes, rumination predicted reduced benefits and increased costs, and mindfulness predicted both increased proactivity and costs. These studies help to refine the self-awareness concept by identifying the unique outcomes associated with the concepts of self-reflection, insight, reflection, rumination and mindfulness. It can be used in future studies to evaluate and develop awareness-raising techniques to maximize self-awareness benefits while minimizing related costs. PMID:27872672

  14. Measuring the Effects of Self-Awareness: Construction of the Self-Awareness Outcomes Questionnaire.

    PubMed

    Sutton, Anna

    2016-11-01

    Dispositional self-awareness is conceptualized in several different ways, including insight, reflection, rumination and mindfulness, with the latter in particular attracting extensive attention in recent research. While self-awareness is generally associated with positive psychological well-being, these different conceptualizations are also each associated with a range of unique outcomes. This two part, mixed methods study aimed to advance understanding of dispositional self-awareness by developing a questionnaire to measure its outcomes. In Study 1, expert focus groups categorized and extended an initial pool of potential items from previous research. In Study 2, these items were reduced to a 38 item self-report questionnaire with four factors representing three beneficial outcomes (reflective self-development, acceptance and proactivity) and one negative outcome (costs). Regression of these outcomes against self-awareness measures revealed that self-reflection and insight predicted beneficial outcomes, rumination predicted reduced benefits and increased costs, and mindfulness predicted both increased proactivity and costs. These studies help to refine the self-awareness concept by identifying the unique outcomes associated with the concepts of self-reflection, insight, reflection, rumination and mindfulness. It can be used in future studies to evaluate and develop awareness-raising techniques to maximize self-awareness benefits while minimizing related costs.

  15. The Oxford hip and knee outcome questionnaires for arthroplasty.

    PubMed

    Pynsent, P B; Adams, D J; Disney, S P

    2005-02-01

    The Oxford hip and knee scores are used to measure the outcome after primary total hip and knee replacement. We propose a new layout for the instrument in which patients are always asked about both limbs. In addition, we have defined an alternative scoring method which accounts for missing data. Over a period of 4.5 years, 4086 (1423 patients) and 5708 (1458 patients) questionnaires were completed for hips and knees, respectively. The hip score had a pre-operative median of 70.8 (interquartile range (IQR) 58.3 to 81.2) decreasing to 20.8 (IQR 10.4 to 35.4) after one year. The knee score had a pre-operative median of 68.8 (IQR 56.2 to 79.2) decreasing to 29.2 (IQR 14.6 to 45.8). There was no further significant change in either score after one year. As a result of the data analysis, we suggest that the score percentiles can be used as a standard for auditing patients before and after operation.

  16. Student Outcomes Report.

    ERIC Educational Resources Information Center

    Clagett, Craig A.

    Prince George's Community College (PGCC) created a Student Outcomes Report in December 1996 that measures course completion, retention, student achievement, program completion, transfer, and certification. Findings indicated that though the course pass rate was 75%, individual course completion ranged from 44% to 100%. Divisional pass rates ranged…

  17. Measuring hearing aid outcomes using the Satisfaction with Amplification in Daily Life (SADL) questionnaire: Australian data.

    PubMed

    Uriarte, Margaret; Denzin, Lauren; Dunstan, Amy; Sellars, Jillian; Hickson, Louise

    2005-06-01

    The aims of this study were to investigate hearing aid satisfaction for a group of older Australians fitted with government-funded hearing aids using the Satisfaction with Amplification in Daily Life (SADL) questionnaire; to compare the Australian data gathered with the provisional normative data reported by Cox and Alexander (1999); and to investigate the relationship between SADL satisfaction and several participant variables, hearing aid variables, and other outcome measures. The SADL questionnaire and a Client Satisfaction Survey (CSS) were distributed by mail to 1284 adults fitted with government-funded hearing aids three to six months previously. 1014 surveys were returned. The mean age of participants was 75.32 years; 54.4% of participants were male, and 54.8% were fitted binaurally. Participants were fitted primarily with digitally programmable hearing aids of various styles (22.5% BTEs, 34.8% ITEs, 41.8% ITCs, 0.9% nonstandard [NS] devices). Overall, participants reported a considerable level of satisfaction with their devices. SADL Global and subscale scores were significantly higher for the Australian sample than the U.S. norms described by Cox and Alexander (1999).

  18. Trends in Teacher Education as Reported on the Institutional Questionnaire.

    ERIC Educational Resources Information Center

    Galluzzo, Gary R.; And Others

    This paper reports on the degree to which teacher educators have addressed the current calls for reform in teacher education. The data were taken from the Institutional Questionnaire of the Research about Teacher Education (RATE) Project of the American Association of Colleges for Teacher Education (AACTE). The 90 respondents, each representing…

  19. Introducing an Outcome Expectation Questionnaire and Its Psychometric Properties Regarding Leisure Time Physical Activity for Iranian Male Adolescent

    PubMed Central

    Abasi, Mohammad Hadi; Eslami, Ahmad Ali; Rakhshani, Fatemeh

    2015-01-01

    Background: Outcome expectation (OE) is known as a psychosocial determinant of leisure time physical activity (LTPA). Despite importance of this construct evaluation, there is no evidence of special questionnaire for measuring OE in Persian speaking Iranian male adolescents. Objectives: This article reports development and psychometric evaluation process of a specific questionnaire that evaluates OE about LTPA among Iranian male adolescents. Materials and Methods: Literature review and group discussions were used to select 26 items of this questionnaire based on 3 dimensions of OE (self-evaluation, social expectancy, and physical expectancy). All Participants (n = 720) were divided into two groups randomly after evaluating comprehensibility, face and content validity, and items analysis. Exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were separately operated on one of these groups for evaluation of the construct validity of questionnaire. The reliability of the questionnaire was estimated by the Cronbach α. Results: EFA extracted 3 main factors explained 45.80%, 10.31%, and 7.51% of OE variance, respectively. Almost all fit indexes in CFA were acceptable (CMIN = 107.39, CMIN/DF = 2.619, CFI = 0.938, PCFI = 0.699, RMSEA = 0.067, PCLOSE = 0.034). Finally 11 items remained in the questionnaire, which showed excellent reliability on main study (α = 0.85). Conclusions: This study provided evidence regarding the reliability and validity of the Iranian male adolescent outcome expectation about leisure time physical activity (IMAO-PAC) and illustrated that this new questionnaire can be used to measure the perceived exercise benefits among target group in observational and interventional studies. PMID:26082851

  20. Development of a Patient-Reported Outcome Instrument to Evaluate Symptoms of Advanced NSCLC: Qualitative Research and Content Validity of the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)

    PubMed Central

    Atkinson, Thomas M.; DeBusk, Kendra P.A.; Liepa, Astra M.; Scanlon, Michael; Coons, Stephen Joel

    2016-01-01

    PURPOSE To describe the process and results of the preliminary qualitative development of a new symptom-based PRO measure intended to assess treatment benefit in advanced non-small cell lung cancer (NSCLC) clinical trials. METHODS Individual qualitative interviews were conducted with adult NSCLC (Stage I–IV) patients in the US. Experienced interviewers conducted concept elicitation (CE) and cognitive interviews using semi-structured interview guides. The CE interview guide was used to elicit spontaneous reports of symptom experiences along with probing to further explore and confirm concepts. Interview transcripts were coded and analyzed by professional qualitative coders using Atlas.ti software, and were summarized by like-content using an iterative coding framework. Data from the CE interviews were considered alongside existing literature and clinical expert opinion during an item-generation process, leading to development of a preliminary version of the NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ). Three waves of cognitive interviews were conducted to evaluate concept relevance, item interpretability, and structure of the draft items to facilitate further instrument refinement. FINDINGS Fifty-one patients (mean age 64.9 [SD=11.2]; 51.0% female) participated in the CE interviews. A total of 1,897 expressions of NSCLC-related symptoms were identified and coded in interview transcripts, representing approximately 42 distinct symptom concepts. A 9-item initial draft instrument was developed for testing in three waves of cognitive interviews with additional NSCLC patients (n=20), during which both paper and electronic versions of the instrument were evaluated and refined. Participant responses and feedback during cognitive interviews led to the removal of 2 items and substantial modifications to others. IMPLICATIONS The NSCLC-SAQ is a 7-item PRO measure intended for use in advanced NSCLC clinical trials to support medical product labelling. The NSCLC-SAQ uses

  1. The Eating Disorder Recovery Self-Efficacy Questionnaire (EDRSQ): change with treatment and prediction of outcome.

    PubMed

    Pinto, Angela Marinilli; Heinberg, Leslie J; Coughlin, Janelle W; Fava, Joseph L; Guarda, Angela S

    2008-04-01

    The purpose of this study was to examine the predictive validity of the Eating Disorder Recovery Self-Efficacy Questionnaire (EDRSQ), an empirically-derived self-report instrument that assesses confidence to eat without engaging in eating disordered behavior or experiencing undue emotional distress (Normative Eating Self-Efficacy) and confidence to maintain a realistic body image that is not dominated by pursuit of thinness (Body Image Self-Efficacy). Participants were 104 female inpatients with anorexia nervosa (AN), subthreshold AN, or underweight bulimia nervosa who were treated at a specialized eating disorder clinic and completed the EDRSQ and Eating Disorder Inventory-2 (EDI-2) Drive for Thinness (DT) and Body Dissatisfaction (BD) subscales upon admission. A subset of patients completed the EDRSQ (n=81) and EDI-2 subscales (n=70) following inpatient treatment. Self-efficacy increased significantly during treatment. EDRSQ scores at admission were inversely related to length of hospital stay and posttreatment DT and BD subscales and positively related to partial hospital weight gain rate. The EDRSQ significantly predicted length of hospital stay and posttreatment BD above and beyond clinical indicators and eating disorder psychopathology at inpatient admission. Findings support the validity of the EDRSQ and suggest it is a useful predictor of short-term hospital treatment outcome in underweight eating disorder patients.

  2. A parent-report gender identity questionnaire for children.

    PubMed

    Johnson, Laurel L; Bradley, Susan J; Birkenfeld-Adams, Andrea S; Kuksis, Myra A Radzins; Maing, Dianne M; Mitchell, Janet N; Zucker, Kenneth J

    2004-04-01

    This paper reports on the psychometric properties of a 16-item parent-report Gender Identity Questionnaire, originally developed by P. H. Elizabeth and R. Green (1984), to aid in the assessment of children with potential problems in their gender identity development. The questionnaire, which covered aspects of the core phenomenology of gender identity disorder (GID), was completed by parents of gender-referred children (N = 325) and controls (siblings, clinic-referred, and nonreferred; N = 504), who ranged in age from 2.5-12 years (mean age, 7.6 years). Factor-analysis indicated that a one-factor solution, containing 14 of the 16 items with factor loadings > or =.30, best fit the data, accounting for 43.7% of the variance. The gender-referred children had a significantly more deviant total score than did the controls, with a large effect size of 3.70. The GIQ total score had negligible age effects, indicating that the questionnaire has utility for assessing change over time. The gender-referred children who met the complete DSM criteria for GID had a significantly more deviant total score than did the children who were subthreshold for GID, although the latter group had a mean score that was closer to the threshold cases than to the controls. With a specificity rate set at 95% for the controls, the sensitivity rate for the probands was 86.8%. It is concluded that this parent-report gender identity questionnaire has excellent psychometric properties and can serve as a useful screening device for front-line clinicians, for whom more extensive, expensive, and time-consuming assessment procedures may be precluded.

  3. Psychometric properties of the Behavioural Outcomes of Anxiety questionnaire in stroke patients with aphasia

    PubMed Central

    Eccles, Alicia; Morris, Reg; Kneebone, Ian

    2016-01-01

    Objective: To evaluate the psychometric properties of an observational, carer-completed anxiety screen for aphasic stroke patients. Design: Phase 1: A cross-sectional questionnaire design to establish psychometric properties. Phase 2: A randomized longitudinal design with treatment and control to evaluate sensitivity to change and repeatability/reliability. Subjects: Phase 1: 111 patient-carer dyads were recruited through stroke charities: patient mean age 69.7(10. 7), 6.2(5. 2) years since stroke, 76 male; carer mean age 64.7(12. 2), 27 male. Phase 2. A subsample of 50 dyads (29 completed). Measures: All patients completed the Tension Rating Circles and the Frenchay Aphasia Screening Test. Carers completed the Behavioural Outcomes of Anxiety questionnaire, observational versions of the Hospital Anxiety and Depression Scale (HADS-A) and the Generalised Anxiety Disorder-7, and a feedback questionnaire. Intervention: Phase 2: 25 dyads were offered relaxation training and 25 acted as controls. Results: The Behavioural Outcomes of Anxiety questionnaire correlated .77 with the HADS-A and Cronbach’s Alpha was .82 demonstrating validity and internal consistency. Using HADS-A cut-off > 7 as criterion the area under the curve was 0.90 and at cut-off of > 16 sensitivity (0.85) and specificity (0.85) were both good. Scores declined significantly more in a group given anxiety training (n = 12) than in a control group (n = 17), demonstrating sensitivity to change and construct validity. Two-week repeatability/reliability was .92. Feedback suggested the scale was acceptable. Conclusions: The Behavioural Outcomes of Anxiety questionnaire shows promise as an anxiety screen for stroke patients with aphasia and is sensitive to change. Further analysis of dimensionality and discriminant validity is needed. PMID:27121863

  4. Is Measured Hearing Aid Benefit Affected by Seeing Baseline Outcome Questionnaire Responses?

    PubMed Central

    Silverman, ShienPei; Cates, Megan; Saunders, Gabrielle

    2016-01-01

    Purpose To determine whether hearing aid outcome measured by the Hearing Handicap Inventory (HHI) for the Elderly/Adults (Newman, Weinstein, Jacobson, & Hug, 1990; Ventry & Weinstein, 1982) is differentially affected by informed vs. blind administration of the postfitting questionnaire. Method Participants completed the HHI at their hearing aid evaluation and again at their hearing aid follow-up visit. At follow-up, half received a clean HHI form (blind administration), whereas the remainder responded on their original form (informed administration) and could thus base their follow-up responses on those they gave at the hearing aid evaluation. Results The data show that for the population examined here, informed administration of the follow-up HHI did not yield a different outcome to blind administration of the follow-up HHI. This was not influenced by past hearing aid use, age of the participant, or the duration of time between baseline questionnaire completion and follow-up completion. Conclusion These data suggest that completion of follow-up questionnaires in either informed or blind format will have little impact on HHI responses, most likely because of the many other factors that combined to influence hearing aid outcome. PMID:21940983

  5. Qualitative interviews vs standardized self-report questionnaires in assessing quality of life in heart transplant recipients.

    PubMed

    Abbey, Susan E; De Luca, Enza; Mauthner, Oliver E; McKeever, Patricia; Shildrick, Margrit; Poole, Jennifer M; Gewarges, Mena; Ross, Heather J

    2011-08-01

    Quality of life (QoL) studies in heart transplant recipients (HTRs) using validated, quantitative, self-report questionnaires have reported poor QoL in approximately 20% of patients. This consecutive mixed methods study compared self-report questionnaires, the Medical Outcomes Study 36-item Short Form Health Survey (MOS SF-36) and the Atkinson Life Satisfaction Scale, with phenomenologically informed audiovisual (AV) qualitative interview data in 27 medically stable HTRs (70% male; age 53 ± 13.77 years; time since transplant 4.06 ± 2.42 years). Self-report questionnaire data reported poor QoL and more distress compared with previous studies and normative population samples; in contrast, 52% of HTRs displayed pervasive distress according to visual methodology. Using qualitative methods to assess QoL yields information that would otherwise remain unobserved by the exclusive use of quantitative QOL questionnaires.

  6. Psychometric validation of the Coronary Revascularisation Outcome Questionnaire (CROQv2) in the context of the NHS Coronary Revascularisation PROMs Pilot

    PubMed Central

    Miles, Rebecca; Green, Stephen; Jackson, Mark

    2017-01-01

    Objectives The Coronary Revascularisation Outcome Questionnaire (CROQ) is a patient-reported outcome measure (PROM) for coronary artery bypass surgery (CABG) and percutaneous coronary intervention (PCI). We tested the psychometric properties of a modified version (CROQv2) when administered in a National Health Service (NHS)/Department of Health (DH) funded pilot of PROMs for coronary revascularisation. Design Psychometric validation study. Setting 11 English hospitals in the UK taking part in the NHS/DH funded pilot of PROMs for coronary revascularisation. Participants Comprehensive analyses of acceptability, reliability, validity and responsiveness were conducted independently for each of the prerevascularisation (n=2685 and n=3711) and postrevascularisation (n=869 and n=837) versions of the CROQ-CABG and CROQ-PCI, respectively. Results All versions met prespecified stringent criteria for (1) acceptability of items (missing data) and scales (missing data, floor and ceiling effects, skewness); (2) tests of scaling assumptions; (3) reliability: internal consistency (Cronbach's α, item-total correlations); (4) construct validity based on within-scale analyses (internal consistency, intercorrelations between scales, factor analysis and hypothesis testing); (5) construct validity based on comparisons with external measures (convergent and discriminant validity and hypothesis testing) and (6) responsiveness. Results were also confirmed when tests were repeated on subsamples of CABG (n=639) and PCI (n=615) patients who reported receiving help completing prerevascularisation questionnaires. Conclusions The availability of a psychometrically robust procedure-specific tool that could be used as part of a large-scale coronary revascularisation PROMs programme to capture the patients' perspective of coronary revascularisation will enable outcomes important to patients to be routinely collected alongside clinical outcomes. The CROQ is suitable for administration by postal

  7. The Michigan Hand Outcomes Questionnaire (MHQ) after 15 years of field trial

    PubMed Central

    Shauver, Melissa J.; Chung, Kevin C.

    2013-01-01

    Background The Michigan Hand Outcomes Questionnaire (MHQ) has been used to assess a variety of hand and upper extremity injuries and conditions for nearly 15 years. It has been included in several overviews of upper extremity outcomes measures, but it has not been systematically examined regarding its clinimetric properties during field trials. Methods We conducted a review of the MHQ in the English language literature from 1998 through March 2012. Data from clinical studies were abstracted and compiled. Results The MHQ has been used in 58 clinical studies and its clinimetric properties have been analyzed in an additional 18 publications. The MHQ compares favorably with other hand outcomes instruments in the areas of test-retest reliability, validity, and responsiveness. High internal consistency may indicate redundancy within the items in the MHQ. The strength of the MHQ is its multidimensional construct in measuring patient-rated outcomes in symptom, function, aesthetics, and satisfaction. Conclusions The MHQ has been applied across a variety of conditions affecting the hand and upper limb. Its psychometric properties have been tested through field trials in various clinical settings around the world. Level of Evidence Systematic Review; Level II PMID:23629117

  8. Patient-Reported Outcome Questionnaire for Systemic Mastocytosis

    ClinicalTrials.gov

    2017-01-06

    Aggressive Systemic Mastocytosis (ASM); SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD); Mast Cell Leukemia (MCL); Smoldering Systemic Mastocytosis (SSM); Indolent Systemic Mastocytosis (ISM) ISM Subgroup Fully Recruited

  9. Longitudinal deteriorations in patient reported outcomes in patients with COPD.

    PubMed

    Oga, Toru; Nishimura, Koichi; Tsukino, Mitsuhiro; Sato, Susumu; Hajiro, Takashi; Mishima, Michiaki

    2007-01-01

    Goals of effective management of patients with chronic obstructive pulmonary disease (COPD) include relieving their symptoms and improving their health status. We examined how such patient reported outcomes would change longitudinally in comparison to physiological outcomes in COPD. One hundred thirty-seven male outpatients with stable COPD were recruited for the study. The subjects health status was evaluated using the St. George's Respiratory Questionnaire (SGRQ) and the Chronic Respiratory Disease Questionnaire (CRQ). Their dyspnoea using the modified Medical Research Council (MRC) scale and their psychological status using the Hospital Anxiety and Depression Scale (HADS) were assessed upon entry and every 6 months thereafter over a 5-year period. Pulmonary function and exercise capacity as evaluated by peak oxygen uptake (VO2) on progressive cycle ergometry were also followed over the same time. Using mixed effects models to estimate the slopes for the changes, scores on the SGRQ, the CRQ, the MRC and the HADS worsened in a statistically significant manner over time. However, changes only weakly correlated with changes in forced expiratory volume in 1s (FEV(1)) and peak (VO2). We demonstrated that although changes in pulmonary function and exercise capacity are well known in patients with COPD, patient reported outcomes such as health status, dyspnoea and psychological status also deteriorated significantly over time. In addition, deteriorations in patient reported outcomes only weakly correlated to changes in physiological indices. To capture the overall deterioration of COPD from the subjective viewpoints of the patients, patient reported outcomes should be followed separately from physiological outcomes.

  10. Outcome-Reporting Bias in Education Research

    ERIC Educational Resources Information Center

    Pigott, Therese D.; Valentine, Jeffrey C.; Polanin, Joshua R.; Williams, Ryan T.; Canada, Dericka D.

    2013-01-01

    Outcome-reporting bias occurs when primary studies do not include information about all outcomes measured in a study. When studies omit findings on important measures, efforts to synthesize the research using systematic review techniques will be biased and interpretations of individual studies will be incomplete. Outcome-reporting bias has been…

  11. Patient-reported outcomes in borderline personality disorder.

    PubMed

    Hasler, Gregor; Hopwood, Christopher J; Jacob, Gitta A; Brändle, Laura S; Schulte-Vels, Thomas

    2014-06-01

    Patient-reported outcome (PRO) refers to measures that emphasize the subjective view of patients about their health-related conditions and behaviors. Typically, PROs include self-report questionnaires and clinical interviews. Defining PROs for borderline personality disorder (BPD) is particularly challenging given the disorder's high symptomatic heterogeneity, high comorbidity with other psychiatric conditions, highly fluctuating symptoms, weak correlations between symptoms and functional outcomes, and lack of valid and reliable experimental measures to complement self-report data. Here, we provide an overview of currently used BPD outcome measures and discuss them from clinical, psychometric, experimental, and patient perspectives. In addition, we review the most promising leads to improve BPD PROs, including the DSM-5 Section III, the Recovery Approach, Ecological Momentary Assessments, and novel experimental measures of social functioning that are associated with functional and social outcomes.

  12. Psychometrics of the Personal Questionnaire: A client-generated outcome measure.

    PubMed

    Elliott, Robert; Wagner, John; Sales, Célia M D; Rodgers, Brian; Alves, Paula; Café, Maria J

    2016-03-01

    We present a range of evidence for the reliability and validity of data generated by the Personal Questionnaire (PQ), a client-generated individualized outcome measure, using 5 data sets from 3 countries. Overall pretherapy mean internal consistency (alpha) across clients was .80, and within-client alphas averaged .77; clients typically had 1 or 2 items that did not vary with the other items. Analyses of temporal structure indicated high levels of between-clients variance (58%), moderate pretherapy test-retest correlation (r = .57), and high session-to-session Lag-1 autocorrelation (.82). Scores on the PQ provided clear evidence of convergence with a range of outcome measures (within-client r = .41). Mean pre-post effects were large (d = 1.25). The results support a revised caseness cutoff of 3.25 and a reliable change index interval of 1.67. We conclude that PQ data meet criteria for evidence-based, norm-referenced measurement of client psychological distress for supporting psychotherapy practice and research.

  13. Questionnaires for outcome expectancy, self-regulation, and behavioral expectation for resistance training among young-old adults: development and preliminary validity.

    PubMed

    Williams, David M; Savla, Jyoti; Davy, Brenda M; Kelleher, Sarah A; Marinik, Elaina L; Winett, Richard A

    2015-04-01

    The purpose of the present research was to develop questionnaires to assess outcome expectancy for resistance training (RT), behavioral expectation in the context of perceived barriers to RT, and self-regulation strategies for RT among young-old adults (50-69 years). Measurement development included (a) item generation through elicitation interviews (N = 14) and open-ended questionnaires (N = 56), (b) expert feedback on a preliminary draft of the questionnaires (N = 4), and (c) a quantitative longitudinal study for item-reduction and psychometric analyses (N = 94). Elicitation procedures, expert feedback, and item reduction yielded four questionnaires with a total of 33 items. Positive outcome expectancy (α = .809), negative outcome expectancy (α = .729), behavioral expectation (α = .925), and self-regulation (α = .761) had-with one exception-moderate bivariate associations with two different indicators of self-reported RT behavior at one-month follow-up (r = .298 to .506). The present research provides preliminary support for newly developed questionnaires to facilitate understanding of the psychosocial determinants of RT among young-old adults.

  14. Measuring visual outcomes in children with uveitis using the “Effects of Youngsters’ Eyesight on Quality of Life” questionnaire

    PubMed Central

    Angeles-Han, Sheila T.; Yeh, Steven; McCracken, Courtney; Jenkins, Kirsten; Stryker, Daneka; Myoung, Erica; Vogler, Larry; Rouster-Stevens, Kelly; Lambert, Scott R.; Harrison, Melanie J.; Prahalad, Sampath; Drews-Botsch, Carolyn

    2015-01-01

    Objective The Effects of Youngsters’ Eyesight on Quality of Life (EYE-Q) is a novel measure of vision-related quality of life (QOL) and function in children. We aim to determine the validity of EYE-Q in childhood uveitis. Methods We abstracted medical record data on arthritis and uveitis in a convenience sample of children with juvenile idiopathic arthritis (JIA) and/or uveitis. In addition to the EYE-Q, parents and patients completed questionnaires on overall QOL (Pediatric QOL Inventory - PedsQL), and physical functioning (Childhood Health Assessment Questionnaire - CHAQ). Results Among 57 children (8 JIA, 24 JIA and uveitis, 25 uveitis alone), 102 ocular examinations were performed within 1 month of completing questionnaires. Uveitis patients had bilateral disease (69%), anterior involvement (78%), synechiae (51%) and cataracts (49%). Children with vision loss in their better eye (visual acuity (VA) 20/50 or worse) had worse EYE-Q (p = 0.006), and PedsQL (p = 0.028), but not CHAQ scores. The EYE-Q moderately correlated with logMAR VA (rs = −0.43), PedsQL (rs = 0.43) and CHAQ (rs = −0.45), but was not correlated with anterior chamber cells or intraocular pressure. The PedsQL and CHAQ did not correlate with VA or cells. There were strong correlations between the parent and child EYE-Q (rs = 0.62). Cronbach's α for the child report was 0.91. The EYE-Q had strong test-retest reliability (rs=0.75). Conclusion The EYE-Q may be an important tool in the assessment of visual outcomes in childhood uveitis and an improvement over general measures in detecting changes in vision-related function. PMID:26037544

  15. Reported Voice Difficulties in Student Teachers: A Questionnaire Survey

    ERIC Educational Resources Information Center

    Fairfield, Carol; Richards, Brian

    2007-01-01

    As professional voice users, teachers are particularly at risk of abusing their voices and developing voice disorders during their career. In spite of this, attention paid to voice care in the initial training and further professional development of teachers is unevenly spread and insufficient. This article describes a questionnaire survey of 171…

  16. Self-Reported Knee Symptoms Assessed by KOOS Questionnaire in Downhill Runners (Skyrunners)

    PubMed Central

    2015-01-01

    Background The knee is the weight-bearing joint most commonly associated with sports injuries, and therefore is most at risk of developing degenerative changes, including osteoarthritis. Skyrunners can be considered to be at risk of developing symptoms of post-traumatic osteoarthritis due to downhill running. Aim The aim of this study was to analyze the health of the knee joints of a large group of these athletes via a specific self-report questionnaire. Methods This study was carried out by asking the participants of seven official Skyraces (22.4±3.1 km length; 1596±393 m elevation) to fill out a questionnaire. Information regarding age, sex, downhill elevation (m) during training and competitions over the last month, and history of previous knee injury was also collected before the participants filled out the Knee injury and Osteoarthritis Outcome Score (KOOS), which is a reliable and validated instrument designed to assess patients’ opinions about their knees and associated problems that can result in post-traumatic osteoarthritis. Athletes were divided into six age groups (from 17 to 70 years) and 12 groups based on the downhill gradient they had covered over the last month (from 1,000 to 40,000 m). Results Six hundred twenty-one questionnaires were collected from 45% of the participants in the seven races. Multivariate analysis revealed that self-reported KOOS scores were unrelated to age, sex and monthly downhill gradient. Only 74 (12%) of the participants reported previous knee injuries. Significant differences in the five subscales of the KOOS were found between skyrunners with and without previous knee injuries (P<0.01). Conclusions In the studied population, regular training for downhill running and participation in Skyraces could not be considered risk factors for subjective knee symptoms. Skyrunners with self-reported histories of knee injuries scored worse on all five subscales of the KOOS. PMID:25902316

  17. Validation of a questionnaire assessing patient's aesthetic and functional outcome after nasal reconstruction: the patient NAFEQ-score.

    PubMed

    Moolenburgh, S E; Mureau, M A M; Duivenvoorden, H J; Hofer, S O P

    2009-05-01

    In determining patient satisfaction with functional and aesthetic outcome after reconstructive surgery, including nasal reconstruction, standardised assessment instruments are very important. These standardised tools are needed to adequately evaluate and compare outcome results. Since no such instrument existed for nasal reconstruction, a standardised evaluation questionnaire was developed to assess aesthetic and functional outcome after nasal reconstruction. Items of the Nasal Appearance and Function Evaluation Questionnaire (NAFEQ) were derived from both the literature and experiences with patients. The NAFEQ was validated on 30 nasal reconstruction patients and a reference group of 175 people. A factor analysis confirmed the arrangement of the questionnaire in two subscales: functional and aesthetic outcome. High Cronbach's alpha values (>0.70) for both subscales showed that the NAFEQ was an internally consistent instrument. This study demonstrated that the NAFEQ can be used as a standardised questionnaire for detailed evaluation of aesthetic and functional outcome after nasal reconstruction. Its widespread use would enable comparison of results achieved by different techniques, surgeons and centres in a standardised fashion.

  18. Measuring Appetite with the Simplified Nutritional Appetite Questionnaire Identifies Hospitalised Older People at Risk of Worse Health Outcomes

    PubMed Central

    PILGRIM, A.L.; BAYLIS, D.; JAMESON, K.A.; COOPER, C.; SAYER, A.A.; ROBINSON, S.M.; ROBERTS, H.C.

    2016-01-01

    Objectives Poor appetite is commonly reported by older people but is rarely measured. The Simplified Nutritional Appetite Questionnaire (SNAQ) was validated to predict weight loss in community dwelling older adults but has been little used in hospitals. We evaluated it in older women on admission to hospital and examined associations with healthcare outcomes. Design Longitudinal observational with follow-up at six months. Setting Female acute Medicine for Older People wards at a University hospital in England. Participants 179 female inpatients. Measurements Age, weight, Body Mass Index (BMI), grip strength, SNAQ, Barthel Index Score, Mini Mental State Examination (MMSE), Geriatric Depression Scale: Short Form (GDS-SF), Malnutrition Universal Screening Tool (MUST), category of domicile and receipt of care were measured soon after admission and repeated at six month follow-up. The length of hospital stay (LOS), hospital acquired infection, readmissions and deaths by follow-up were recorded. Results 179 female participants mean age 87 (SD 4.7) years were recruited. 42% of participants had a low SNAQ score (<14, indicating poor appetite). A low SNAQ score was associated with an increased risk of hospital acquired infection (OR 3.53; 95% CI: 1.48, 8.41; p=0.004) and with risk of death (HR 2.29; 95% CI: 1.12, 4.68; p = 0.023) by follow-up. Conclusion Poor appetite was common among the older hospitalised women studied, and was associated with higher risk of poor healthcare outcomes. PMID:26728926

  19. Development of a Self-Report Tool to Evaluate Hearing Aid Outcomes among Chinese Speakers

    ERIC Educational Resources Information Center

    Wong, Lena L. N.; Hang, Na

    2014-01-01

    Purpose: This article reports on the development of a self-report tool--the Chinese Hearing Aid Outcomes Questionnaire (CHAOQ)--to evaluate hearing aid outcomes among Chinese speakers. Method: There were 4 phases to construct the CHAOQ and evaluate its psychometric properties. First, items were selected to evaluate a range of culturally relevant…

  20. Student Outcomes: Annual Summary Report.

    ERIC Educational Resources Information Center

    Prince George's Community Coll., Largo, MD. Office of Institutional Research.

    Each year a study is conducted at Prince George's Community College (PGCC) to update student outcomes data using quantifiable measures of student achievement. Data for the 1989 study were obtained from the college's student information system, the University of Maryland (UM) system, and surveys of all 825 fiscal year 1988 graduates and 118 of…

  1. Development of a Short Questionnaire to Measure an Extended Set of Job Demands, Job Resources, and Positive Health Outcomes: The New Brief Job Stress Questionnaire

    PubMed Central

    INOUE, Akiomi; KAWAKAMI, Norito; SHIMOMITSU, Teruichi; TSUTSUMI, Akizumi; HARATANI, Takashi; YOSHIKAWA, Toru; SHIMAZU, Akihito; ODAGIRI, Yuko

    2014-01-01

    This study aimed to investigate the reliability and construct validity of a new version of the Brief Job Stress Questionnaire (New BJSQ), which measures an extended set of psychosocial factors at work by adding new scales/items to the current version of the BJSQ. Additional scales/items were extensively collected from theoretical job stress models and similar questionnaires in several countries. Scales/items were field-tested and refined through a pilot internet survey. Finally, an 84-item questionnaire (141 items in total when combined with the current BJSQ) was developed. A nationally representative survey was administered to employees in Japan (n=1,633) to examine the reliability and construct validity. Most scales showed acceptable levels of internal consistency and test-retest reliability. Principal component analyses showed that the first factor explained 50% or greater proportion of the variance in most scales. A scale factor analysis and a correlation analysis showed that these scales fit the theoretical expectations. These findings provided a piece of evidence that the New BJSQ scales are reliable and valid. Although more detailed content and construct validity should be examined in future study, the New BJSQ is a useful instrument to evaluate psychosocial work environment and positive mental health outcomes in the current workplace. PMID:24492763

  2. Self reported risk behaviour among injecting drug users: self versus assisted questionnaire completion.

    PubMed

    White, B; Day, C; Maher, L

    2007-03-01

    The current study aimed to compare self-reported injecting and sexual risk behaviour among Needle and Syringe Program (NSP) attendees who self-completed a questionnaire to that of those who received assistance in completing the questionnaire. Information on demographic, injecting and sexual risk behaviour was collected via a self-completed questionnaire for an annual cross-sectional survey of injecting drug users (IDUs) recruited from sentinel NSPs around Australia. Assistance was provided when necessary and recorded. Of 2,035 participants, 1,452 (71%) reported completing the questionnaire without assistance. Being male and nominating a language other than English spoken at home was independently associated with receiving assistance with questionnaire completion. Participants who reported heroin as the drug last injected were also more likely to receive assistance. Multivariate analyses revealed those who received assistance with questionnaire completion were less likely to report re-using a syringe after someone else and less likely to report sex work in the past month. The current findings suggest self-completion of risk behaviour questionnaires should be considered as an alternative to interviewer administered questionnaires to maximise accuracy of self-reports.

  3. Prospects: Student Outcomes. Final Report.

    ERIC Educational Resources Information Center

    Puma, Michael J.; Karweit, Nancy; Price, Cristofer; Ricciuti, Anne; Thompson, William; Vaden-Kiernan, Michael

    This report is one of a series presenting findings from "Prospects: The Congressionally Mandated Study of Educational Growth and Opportunity." This study, conducted in response to the 1988 Hawkins-Stafford Amendments, was a major effort to examine the effects of Chapter 1 on student achievement and other school-related educational…

  4. Validating a Children's Self-Report Plate Waste Questionnaire

    ERIC Educational Resources Information Center

    Forrestal, Sarah G.; Issel, L. Michele; Kviz, Frederick J.; Chávez, Noel

    2008-01-01

    Purpose/Objectives: The National School Lunch Program is well situated to address the vulnerability of lower income children at increased risk for both under and overnutrition. Evidence suggests, however, that a significant amount of food served in the program goes uneaten. One way to monitor this problem is through children's self-reported plate…

  5. Construction of a traditional Chinese medicine syndrome-specific outcome measure: the Kidney Deficiency Syndrome questionnaire (KDSQ)

    PubMed Central

    2012-01-01

    Background Development of Traditional Chinese Medicine (TCM) syndrome-specific outcome measures is needed for the evaluation of TCM syndrome-specific therapies. We constructed a Kidney Deficiency Syndrome Questionnaire (KDSQ) for the evaluation of the common TCM syndromes Kidney-Yin Deficiency Syndrome (KDS-Yin) and Kidney-Yang Deficiency Syndrome (KDS-Yang) in middle-aged women with menopausal symptoms. Methods KDS-Yin and KDS-Yang were traditionally defined by expert opinion were validated by exploratory factor analysis (EFA) and structural equation modeling (SEM). Content validity was tested by EFA on a sample of 236 women from a seminar and SEM on another sample of 321 women from a postal survey. Other psychometric properties were tested on 292 women from the seminar at baseline and two systematically selected sub-samples: 54 who reported no changes in discomforts 11–12 days after the baseline and 31 who reported changes in discomforts 67–74 days after the baseline. All participants completed the KDSQ, the Greene Climacteric Scale and the standard 12-item Short Form Health Survey. Results The EFA and SEM established the measurement models of KDS-Yin and KDS-Yang supporting content validity of the KDSQ. Internal consistency was good (Cronbach’s Alpha >0.70). Construct validity was supported by theoretically-derived levels of correlation with the established external measures. Test–retest reliability was strong (ICCagreement: KDS-Yin, 0.94; KDS-Yang, 0.93). The KDSQ was responsive to changes over time as tested by effect size and longitudinal validity. Conclusions The KDSQ was a valid and reliable measure for KDS-Yin and KDS-Yang in Hong Kong Chinese middle-aged women with menopausal symptoms. PMID:22672362

  6. Residential Learning Outcomes: Analysis Using the College Student Experiences Questionnaire at a Large Public Research University

    ERIC Educational Resources Information Center

    Murphy, Cari

    2010-01-01

    The creation of learning outcomes inside and outside of the classroom on college campuses has been a growing trend based on a variety of publications which encouraged the fostering of diverse types learning and the measurement of student learning outside of the classroom (ACPA, 1994; Keeling, 2004). The creation of the learning outcomes is a…

  7. The Early Motor Questionnaire (EMQ): A Parental Report Measure of Early Motor Development

    PubMed Central

    Libertus, Klaus; Landa, Rebecca J.

    2013-01-01

    Children's early motor skills are critical for development across language, social, and cognitive domains, and warrant close examination. However, examiner-administered motor assessments are time consuming and expensive. Parent-report questionnaires offer an efficient alternative, but validity of parent report is unclear and only few motor questionnaires exist. In this report, we use cross-sectional and longitudinal data to investigate the validity of parent report in comparison to two examiner-administered measures (Mullen Scales of Early Learning, MSEL; Peabody Developmental Motor Scales, PDMS-2), and introduce a new parent-report measure called the Early Motor Questionnaire (EMQ). Results indicate strong correlations between parent report on the EMQ and a child's age, robust concurrent and predictive validity of parent report with both the MSEL and PDMS-2, and good test-re-test reliability of parent report on the EMQ. Together, our findings support the conclusion that parents provide dependable accounts of early motor and cognitive development. PMID:24140841

  8. Discordant patient pain level reporting between questionnaires and physician encounters of the same day

    PubMed Central

    Juckett, David A.; Davis, Fred N.; Gostine, Mark; Kasten, Eric P.; Reed, Philip L.; Gardiner, Joseph; Risko, Rebecca

    2016-01-01

    We examined the consistency of pain reporting by patients in a community pain management practice in Michigan. We compared pain levels (range 0-10) entered by patients in questionnaires versus those provided during their face-to-face physician encounter on the same day. Both of these values were available for approximately 10,000 encounters during the study period (2010–2014). Two subpopulations of patients were identifiable. One was consistent in reporting worst or least pain levels on the questionnaire and during the provider encounter. The other was discordant. Factor analysis had previously identified severity scales for patient biopsychosocial characteristics derived from the full questionnaire. The two subpopulations differed in their factor profiles even though they had similar demographics. In general, pain reported directly to physicians was more correlated to biopsychosocial indicators. Pain self-reporting using questionnaires has often been assumed to be ground truth, but those obtained during the physician encounter may be more reliable. PMID:28269863

  9. Affective Outcomes of Schooling: Full-Information Item Factor Analysis of a Student Questionnaire.

    ERIC Educational Resources Information Center

    Muraki, Eiji; Engelhard, George, Jr.

    Recent developments in dichotomous factor analysis based on multidimensional item response models (Bock and Aitkin, 1981; Muthen, 1978) provide an effective method for exploring the dimensionality of questionnaire items. Implemented in the TESTFACT program, this "full information" item factor analysis accounts not only for the pairwise joint…

  10. Alaska Performance Scholarship Outcomes Report 2014

    ERIC Educational Resources Information Center

    Rae, Brian

    2014-01-01

    The 2014 Alaska Performance Scholarship (APS) Outcomes Report analyzes the characteristics of high school graduates, those who were eligible to receive the scholarship, and those who went on to make use of it during the three years of the scholarship's existence. The analysis includes their geographic, gender, ethnic, and socioeconomic…

  11. Clinical Assessment of Affective Instability: Comparing EMA Indices, Questionnaire Reports, and Retrospective Recall

    ERIC Educational Resources Information Center

    Solhan, Marika B.; Trull, Timothy J.; Jahng, Seungmin; Wood, Phillip K.

    2009-01-01

    Traditional self-report measures of psychopathology may be influenced by a variety of recall biases. Ecological momentary assessment (EMA) reduces these biases by assessing individuals' experiences as they occur in their natural environments. This study examines the discrepancy between trait questionnaire, retrospective report, and EMA measures of…

  12. Validation of questionnaire-reported hearing with medical records: A report from the Swiss Childhood Cancer Survivor Study

    PubMed Central

    Scheinemann, Katrin; Grotzer, Michael; Kompis, Martin; Kuehni, Claudia E.

    2017-01-01

    Background Hearing loss is a potential late effect after childhood cancer. Questionnaires are often used to assess hearing in large cohorts of childhood cancer survivors and it is important to know if they can provide valid measures of hearing loss. We therefore assessed agreement and validity of questionnaire-reported hearing in childhood cancer survivors using medical records as reference. Procedure In this validation study, we studied 361 survivors of childhood cancer from the Swiss Childhood Cancer Survivor Study (SCCSS) who had been diagnosed after 1989 and had been exposed to ototoxic cancer treatment. Questionnaire-reported hearing was compared to the information in medical records. Hearing loss was defined as ≥ grade 1 according to the SIOP Boston Ototoxicity Scale. We assessed agreement and validity of questionnaire-reported hearing overall and stratified by questionnaire respondents (survivor or parent), sociodemographic characteristics, time between follow-up and questionnaire and severity of hearing loss. Results Questionnaire reports agreed with medical records in 85% of respondents (kappa 0.62), normal hearing was correctly assessed in 92% of those with normal hearing (n = 249), and hearing loss was correctly assessed in 69% of those with hearing loss (n = 112). Sensitivity of the questionnaires was 92%, 74%, and 39% for assessment of severe, moderate and mild bilateral hearing loss; and 50%, 33% and 10% for severe, moderate and mild unilateral hearing loss, respectively. Results did not differ by sociodemographic characteristics of the respondents, and survivor- and parent-reports were equally valid. Conclusions Questionnaires are a useful tool to assess hearing in large cohorts of childhood cancer survivors, but underestimate mild and unilateral hearing loss. Further research should investigate whether the addition of questions with higher sensitivity for mild degrees of hearing loss could improve the results. PMID:28333999

  13. Patient-reported outcome measures for asthma: a systematic review

    PubMed Central

    Worth, Allison; Hammersley, Victoria; Knibb, Rebecca; Flokstra-de-Blok, Bertine; DunnGalvin, Audrey; Walker, Samantha; Dubois, Anthony E J; Sheikh, Aziz

    2014-01-01

    Background: Patient-reported outcome measures (PROMs) are measures of the outcome of treatment(s) reported directly by the patient or carer. There is increasing international policy interest in using these to assess the impact of clinical care. Aims: To identify suitably validated PROMs for asthma and examine their potential for use in clinical settings. Methods: We systematically searched MEDLINE, EMBASE and Web of Science databases from 1990 onwards to identify PROMs for asthma. These were critically appraised, then narratively synthesised. We also identified the generic PROMs commonly used alongside asthma-specific PROMs. Results: We identified 68 PROMs for asthma, 13 of which were selected through screening as being adequately developed to warrant full-quality appraisal: 8 for adults, 4 for children and 1 for a child’s caregiver. The PROMs found to be sufficiently well validated to offer promise for use in clinical settings were the Asthma Quality of Life Questionnaire (AQLQ) and mini-AQLQ for adults, and Pediatric Asthma Quality of Life Questionnaire for children. Rhinasthma was considered promising in simultaneously assessing the impact of asthma and rhinitis in those with coexistent disease. We identified 28 generic PROMs commonly used in conjunction with asthma-specific instruments. Conclusions: We identified asthma PROMs that offer the greatest potential for use in clinical settings. Further work is needed to assess whether these are fit-for-purpose for use in clinical practice with individual patients. In particular, there is a need to ensure these are validated for use in clinical settings, acceptable to patients, caregivers and clinicians, and yield meaningful outcomes. PMID:24964767

  14. Using Data Linkage to Investigate Inconsistent Reporting of Self-Harm and Questionnaire Non-Response

    PubMed Central

    Mars, Becky; Cornish, Rosie; Heron, Jon; Boyd, Andy; Crane, Catherine; Hawton, Keith; Lewis, Glyn; Tilling, Kate; Macleod, John; Gunnell, David

    2016-01-01

    The objective of this study was to examine agreement between self-reported and medically recorded self-harm, and investigate whether the prevalence of self-harm differs in questionnaire responders vs. non-responders. A total of 4,810 participants from the Avon Longitudinal Study of Parents and Children (ALSPAC) completed a self-harm questionnaire at age 16 years. Data from consenting participants were linked to medical records (number available for analyses ranges from 205–3,027). The prevalence of self-harm leading to hospital admission was somewhat higher in questionnaire non-responders than responders (2.0 vs. 1.2%). Hospital attendance with self-harm was under-reported on the questionnaire. One third reported self-harm inconsistently over time; inconsistent reporters were less likely to have depression and fewer had self-harmed with suicidal intent. Self-harm prevalence estimates derived from self-report may be underestimated; more accurate figures may come from combining data from multiple sources. PMID:26789257

  15. Linking questionnaire reports and observer ratings of young couples’ hostility and support

    PubMed Central

    Lorenz, Frederick O.; Melby, Janet N.; Conger, Rand D.; Surjadi, Florenzia F.

    2012-01-01

    Past studies have correlated observer ratings with questionnaire self- and partner-reports of behaviors in close relationships. However, few studies have actually proposed and tested longitudinal models that link observer ratings to past behaviors and to questionnaire self- and partner-reports of behaviors during an observational task. Using data from a panel of 324 young couples, we demonstrate that (1) observer ratings of hostility and support are significantly related to couple reports of the same behavior in the relationship two years earlier, and (2) respondent and partner questionnaire reports of hostility and support during the observational task converge with observer ratings of the same behavior even after controlling for earlier self- and partner-reports. These findings demonstrate that observer reports based on brief discussion tasks reflect the tenor of the relationship over a relatively long period of time. They also demonstrate that couple reports of hostile interactions reflect observable behaviors beyond that attributed to earlier self- and partner-reports. Consistent with previous research, effect sizes are larger for hostility than support but there are few differences between men and women. PMID:22662768

  16. Colorado Learning Difficulties Questionnaire: Validation of a Parent-Report Screening Measure

    ERIC Educational Resources Information Center

    Willcutt, Erik G.; Boada, Richard; Riddle, Margaret W.; Chhabildas, Nomita; DeFries, John C.; Pennington, Bruce F.

    2011-01-01

    This study evaluated the internal structure and convergent and discriminant evidence for the Colorado Learning Difficulties Questionnaire (CLDQ), a 20-item parent-report rating scale that was developed to provide a brief screening measure for learning difficulties. CLDQ ratings were obtained from parents of children in 2 large community samples…

  17. Does Participation in an Intervention Affect Responses on Self-Report Questionnaires?

    ERIC Educational Resources Information Center

    Baranowski, Tom; Allen, Diane D.; Masse, Louise C.; Wilson, Mark

    2006-01-01

    There has been some concern that participation in an intervention and exposure to a measurement instrument can change participants' interpretation of the items on a self-report questionnaire thereby distorting subsequent responses and biasing results. Differential item functioning (DIF) analysis using item response modeling can ascertain possible…

  18. Evaluation Report 1-C-4: End-of-Year Data from Teacher Questionnaires.

    ERIC Educational Resources Information Center

    Holz, Alan; And Others

    This evaluation report is one of 17 planned for the longitudinal pilot study of the implementation in kindergarten and grade 1 of the Comprehensive School Mathematics Program (CSMP). Teachers using the CSMP curricula in kindergarten and first-grade classrooms were asked to complete questionnaires concerning implementation problems, timing and…

  19. Staff Behavior toward Children and Adolescents in a Residential Facility: A Self-Report Questionnaire

    ERIC Educational Resources Information Center

    Huitink, C.; Embregts, P. J. C. M.; Veerman, J. W.; Verhoeven, L.

    2011-01-01

    The purpose of the present study was to examine psychometric properties of the Staff Behavior toward Clients questionnaire (SBC), a self-report measure for care staff working with children and adolescents with mild to borderline intellectual disabilities in residential care. Ninety-nine care staff completed the SBC and the Strengths and…

  20. A Comparison of Father and Mother Report of Child Behaviour on the Strengths and Difficulties Questionnaire

    ERIC Educational Resources Information Center

    Dave, Shreya; Nazareth, Irwin; Senior, Rob; Sherr, Lorraine

    2008-01-01

    To date there has been no comparison of father and mother report on the Strengths and Difficulties Questionnaire (SDQ), a standardised measure of child behaviour used widely in the UK in clinical practice and research. The objectives of the study were to investigate differences and agreement between parents on the various SDQ domains of child…

  1. The Individual Consistency of Acquiescence and Extreme Response Style in Self-Report Questionnaires

    ERIC Educational Resources Information Center

    Weijters, Bert; Geuens, Maggie; Schillewaert, Niels

    2010-01-01

    The severity of bias in respondents' self-reports due to acquiescence response style (ARS) and extreme response style (ERS) depends strongly on how consistent these response styles are over the course of a questionnaire. In the literature, different alternative hypotheses on response style (in)consistency circulate. Therefore, nine alternative…

  2. Patient reported outcomes in the assessment of premature ejaculation.

    PubMed

    Althof, Stanley E

    2016-08-01

    The term 'Patient Reported Outcome', abbreviated as PRO, was introduced by the US Food and Drug Administration (FDA) which proposed guidance on the development and validation of PROs. Previously PROs were known as self-report diaries, event-logs, self-administered questionnaires, and clinician administered rating scales. PROs seek to capture the subjective perceptions of patients and/or partner's related to their specific symptoms, degree of bother, efficacy of a medication or psychotherapy intervention, and quality of life issues related to a specific condition. This article reviews the essential psychometric and regulatory agency requirements in the development of PROs. The constructs of reliability, various forms of validity, sensitivity, and specificity as well as concerns with translating a PRO into a different language are reviewed. Three PROs, the Premature Ejaculation Profile (PEP), the Index of Premature Ejaculation (IPE) and the Premature Ejaculation Diagnostic Tool (PEDT) all used in the assessment of premature ejaculation (PE) are discussed. These questionnaires meet or exceed all the psychometric requirements and have been employed in clinical trials and observational studies of men with PE. The article concludes on discussing some of the limitations of PRO use and recommendations for the future.

  3. Patient-Reported Outcome Measures for Hand and Wrist Trauma

    PubMed Central

    Dacombe, Peter Jonathan; Amirfeyz, Rouin; Davis, Tim

    2016-01-01

    Background: Patient-reported outcome measures (PROMs) are important tools for assessing outcomes following injuries to the hand and wrist. Many commonly used PROMs have no evidence of reliability, validity, and responsiveness in a hand and wrist trauma population. This systematic review examines the PROMs used in the assessment of hand and wrist trauma patients, and the evidence for reliability, validity, and responsiveness of each measure in this population. Methods: A systematic review of Pubmed, Medline, and CINAHL searching for randomized controlled trials of patients with traumatic injuries to the hand and wrist was carried out to identify the PROMs. For each identified PROM, evidence of reliability, validity, and responsiveness was identified using a further systematic review of the Pubmed, Medline, CINAHL, and reverse citation trail audit procedure. Results: The PROM used most often was the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire; the Patient-Rated Wrist Evaluation (PRWE), Gartland and Werley score, Michigan Hand Outcomes score, Mayo Wrist Score, and Short Form 36 were also commonly used. Only the DASH and PRWE have evidence of reliability, validity, and responsiveness in patients with traumatic injuries to the hand and wrist; other measures either have incomplete evidence or evidence gathered in a nontraumatic population. Conclusions: The DASH and PRWE both have evidence of reliability, validity, and responsiveness in a hand and wrist trauma population. Other PROMs used to assess hand and wrist trauma patients do not. This should be considered when selecting a PROM for patients with traumatic hand and wrist pathology. PMID:27418884

  4. The Possible Effects of Various Reporting Methods on Learning Outcomes.

    ERIC Educational Resources Information Center

    Ingenkamp, Karlheinz

    1986-01-01

    Two quasi-experimental longitudinal studies, conducted by the Centre for Educational Research in Landau, Germany, are reported. Various effects of reporting the outcomes of learning to students were studied. Results emphasized the importance of feedback for learning outcomes. (LMO)

  5. Patient Reported Outcomes from Sacroiliac Joint Fusion

    PubMed Central

    McGowan, Shane M.; Audley, Brittany N.; Sokunbi, Gbolabo; Puccio, Steven T.

    2017-01-01

    Study Design Retrospective, case series. Purpose The purpose of this study is to determine morbidity, complications, and patient reported outcomes from minimally invasive sacroiliac joint (SIJ) fusion. Overview of Literature Lumbar back pain emanating from the SIJ can be surgically treated via a percutaneous approach in the appropriately selected patient with minimal morbidity and acceptable functional outcomes. Methods Patients diagnosed by >2 physical examination maneuvers and subjective relief from a computed tomography–guided lidocaine-bupivacaine-steroid injection underwent SIJ fusion after failing conservative management with a combination of oral anti-inflammatory medications, physical therapy, and pelvic belt stabilization. Perioperative data collected include estimated blood loss (EBL) and operative time. Oswestry disability index, 12-item short form health survey (SF-12), visual analogue score, and functional status were analyzed. All complications were noted. Results The study cohort of 45 cases (69% female) achieved postoperative survey follow-up at 9.9 and 32.3 months. SF-12 physical component summary statistically improved while all other scores were equivalent. Mean EBL and operative time were 22 mL and 36 minutes, respectively. Initial survey showed that 64% of patients discontinued narcotics (29/45), 71% do not use an assistive device (32/45), and 15.6% do not work due to pain (7/45). 73% of patients stated they would have the surgery again (33/45). For the second survey, 65% of patients discontinued narcotics (26/40), 70% did not use an assistive device (28/40), and 17.5% did not work due to pain (7/40). A history of thoracolumbar instrumentation (16/45) did not significantly affect outcomes. Three complications described by screw malposition with neurologic deficit (6.7%) were treated with screw repositioning (1 case) and removal of a single superior implant (2 cases) with time to revision of 2.2 months. All three ultimately had resolution of

  6. Depression in chronic low back pain patients: diagnostic efficiency of three self-report questionnaires.

    PubMed

    Love, A W

    1987-01-01

    Three self-report questionnaires (the Beck Depression Inventory, the MMPI-D scale, and the depression subscale of the Middlesex Hospital Questionnaire) were examined to see how accurately they could identify chronic low back pain patients who were suffering depression, as defined by DSM-III criteria. According to these criteria, 25% of a sample of 68 patients currently were depressed, a rate comparable to those reported by other studies that have used standardized criteria. On the basis of relative conditional probability ratios, the BDI was shown to be the most efficient instrument for identifying these cases and represents an excellent screening device for depression with this population. The individual items of the BDI then were examined, and the conditional probability ratios revealed that several may be helpful as indicators of possible depression among chronic low back pain patients. The relationship between depression and chronic pain is reconsidered in the light of these results.

  7. Measuring changes in self-concept: a qualitative evaluation of outcome questionnaires in people having acupuncture for their chronic health problems

    PubMed Central

    Paterson, Charlotte

    2006-01-01

    Background Changes in self-concept are an important potential outcome for many interventions for people with long-term conditions. This study sought to identify and evaluate outcome questionnaires suitable for quantifying changes in self-concept in people with long-term conditions, in the context of treatment with acupuncture and Chinese medicine. Methods A literature search was followed by an evaluation of three questionnaires: The Wellbeing Questionnaire W-BQ12, the Patient Enablement Instrument (PEI), and the Arizona Integrative Outcome Scale (AIOS). A convenience sample of 23 people completed the questionnaires on two occasions and were interviewed about their experience and their questionnaire responses. All acupuncturists were interviewed. Results Changes in self-concept were common and emerged over time. The three questionnaires had different strengths and weaknesses in relation to measuring changes in self-concept. The generic AIOS had face validity and was sensitive to changes in self-concept over time, but it lacked specificity. The PEI was sensitive and specific in measuring these changes but had lower acceptability. The sensitivity of the W-BQ12 was affected by initial high scores (ceiling effect) and a shorter timescale but was acceptable and is suitable for repeated administration. The PEI and W-BQ12 questionnaires worked well in combination. Conclusion Changes in self-concept are important outcomes of complex interventions for people with long-term illness and their measurement requires carefully evaluated tools and long-term follow-up. The literature review and the analysis of the strengths and weaknesses of the questionnaires is a resource for other researchers. The W-BQ12 and the PEI both proved useful for this population and a larger quantitative study is planned. PMID:16539737

  8. Patient-reported outcomes in idiopathic pulmonary fibrosis research.

    PubMed

    Swigris, Jeffrey J; Fairclough, Diane

    2012-08-01

    Patient-reported outcomes (PROs) include questionnaires or surveys that ask patients for their perceptions about things like symptoms they are experiencing or quality of life. For incurable, morbid, life-shortening conditions like idiopathic pulmonary fibrosis (IPF), PROs are particularly germane: They elucidate for clinicians and researchers what it is like for patients to live with such a disease, and they may detect important treatment effects not captured by other metrics (eg, pulmonary physiology). However, a relative paucity of research on PROs in IPF has left significant knowledge gaps in this area and contributed to the timidity investigators have about using PROs as prominent outcomes in IPF drug trials. Additional research on existing instruments is needed to establish or bolster their basic psychometric properties in IPF. When PROs are used as end points in therapeutic trials, analyzing PRO response data can be challenging, but these challenges can be overcome with a transparent, thoughtful, and sophisticated statistical approach. In this article, we discuss some of the basics of PRO assessment, existing knowledge gaps in IPF-related PRO research, and the potential usefulness of using PROs in IPF trials and conclude by offering specific recommendations for an approach to analyzing repeated-measures PRO data from IPF trials.

  9. Assessment of quality-of-life outcomes after surgery for nasal polyposis with the DyNaChron questionnaire.

    PubMed

    Nguyen, Duc Trung; Guillemin, Francis; Arous, Fabien; Jankowski, Roger

    2015-02-01

    This prospective study assesses outcomes at 6 weeks and 7 months after radical ethmoid surgery in 65 patients with nasal polyposis using a new and detailed instrument, the DyNaChron questionnaire, which was filled in the day prior to surgery and at 6 weeks and 7 months after surgery at follow-up visits. Before surgery, the leading bothersome symptoms were olfactory disturbances (7.74 ± 2.81) and nasal obstruction (6.66 ± 2.28). After surgery (6th week and 7th month), there was a clear improvement of all symptoms including nasal obstruction, olfactory disturbances, anterior rhinorrhea, postnasal discharge, facial pain/headache and cough in comparison to baseline (p < 0.0001). Nasal obstruction was the most improved symptom (effect size of 2.24). At 7th post-operative month, the sense of smell continued to improve slightly. By contrast, the postnasal discharge score that was significantly improved at 6th post-operative week tended to worsen at 7 months (p = 0.0045). Before surgery, strong psychosocial impacts were observed in association with nasal obstruction and anterior rhinorrhea. The physical impacts of each symptom were proportionally correlated to the symptom score before and after surgery. The quality of life (QOL) related to each symptom was clearly better at 6 weeks and remained steady at 7 months after surgery. In conclusion, olfactory disorders and postnasal rhinorrhea were the main remaining symptoms after sinus surgery despite a global improvement of symptoms and quality of life. The earlier time point to stabilize QOL outcomes of endoscopic sinus surgery could be suggested at 6 weeks after surgery.

  10. Child Welfare Outcomes 2002-2005. Report to Congress

    ERIC Educational Resources Information Center

    US Department of Health and Human Services, 2008

    2008-01-01

    "Child Welfare Outcomes 2002-2005: Report to Congress" (Child Welfare Outcomes Report) is the seventh in a series of annual reports from the U.S. Department of Health and Human Services (the Department). The reports are developed in accordance with section 479A of the Social Security Act (as amended by the Adoption and Safe Families Act…

  11. Measurement properties of patient-reported outcome measures (PROMS) in Patellofemoral Pain Syndrome: a systematic review.

    PubMed

    Green, Andrew; Liles, Clive; Rushton, Alison; Kyte, Derek G

    2014-12-01

    This systematic review investigated the measurement properties of disease-specific patient-reported outcome measures used in Patellofemoral Pain Syndrome. Two independent reviewers conducted a systematic search of key databases (MEDLINE, EMBASE, AMED, CINHAL+ and the Cochrane Library from inception to August 2013) to identify relevant studies. A third reviewer mediated in the event of disagreement. Methodological quality was evaluated using the validated COSMIN (Consensus-based Standards for the Selection of Health Measurement Instruments) tool. Data synthesis across studies determined the level of evidence for each patient-reported outcome measure. The search strategy returned 2177 citations. Following the eligibility review phase, seven studies, evaluating twelve different patient-reported outcome measures, met inclusion criteria. A 'moderate' level of evidence supported the structural validity of several measures: the Flandry Questionnaire, Anterior Knee Pain Scale, Functional Index Questionnaire, Eng and Pierrynowski Questionnaire and Visual Analogue Scales for 'usual' and 'worst' pain. In addition, there was a 'Limited' level of evidence supporting the test-retest reliability and validity (cross-cultural, hypothesis testing) of the Persian version of the Anterior Knee Pain Scale. Other measurement properties were evaluated with poor methodological quality, and many properties were not evaluated in any of the included papers. Current disease-specific outcome measures for Patellofemoral Pain Syndrome require further investigation. Future studies should evaluate all important measurement properties, utilising an appropriate framework such as COSMIN to guide study design, to facilitate optimal methodological quality.

  12. Development and Validation of the "iCAN!"--A Self-Administered Questionnaire Measuring Outcomes/Competences and Professionalism of Medical Graduates

    ERIC Educational Resources Information Center

    Dimoliatis, Ioannis D. K.; Lyrakos, Georgios N.; Tseretopoulou, Xanthippi; Tzamalis, Theodoros; Bazoukis, George; Benos, Alexis; Gogos, Charalambos; Malizos, Konstantinos; Pneumatikos, Ioannis; Thermos, Kyriaki; Kaldoudi, Eleni; Tzaphlidou, Margaret; Papadopoulos, Iordanis N.; Jelastopulu, Eleni

    2014-01-01

    The Tuning-Medicine Project produced a set of "level one" and "level two" learning outcomes/competences to be met by European medical graduates. In the learner-centered era self-assessment becomes more and more important. Our aim was to develop a self-completion questionnaire ("iCAN!") evaluating graduates' learning…

  13. Patient reported outcomes in hip arthroplasty registries.

    PubMed

    Paulsen, Aksel

    2014-05-01

    PROs are used increasingly in orthopedics and in joint registries, but still many aspects of use in this area have not been examined in depth. To be able to introduce PROs in the DHR in a scientific fashion, my studies were warranted; the feasibility of four often used PROs (OHS, HOOS, EQ-5D and SF-12) was examined in a registry context. Having the PROs in the target language is an absolute necessity, so I translated, cross-culturally adapted and validated a Danish language version of an often used PRO (OHS), since this PRO had no properly developed Danish language version. To minimize data loss and to maximize the data quality I validated our data capture procedure, an up to date AFP system, by comparing scannable, paper-based PROs, with manual single-key- and double-key entered data. To help further registry-PRO studies, I calculated the number of patients needed to discriminate between subgroups of age, sex, diagnosis, and prosthesis type for each of four often used PROs (OHS, HOOS, EQ-5D and SF-12), and to simplify the clinical interpretation of PRO scores and PRO change scores in PRO studies, I estimated MCII and PASS for two often used PROs (EQ-5D and HOOS). The feasibility study included 5,747 THA patients registered in the DHR, and I found only minor differences between the disease-specific and the generic PROs regarding ceiling and floor effects as well as discarded items. The HOOS, the OHS, the SF-12, and the EQ-5D are all appropriate PROs for administration in a hip registry. I found that group sizes from 51 to 1,566 were needed for subgroup analysis, depending on descriptive factors and choice of PRO. The AFP study included 200 THA patients (398 PROs, 4,875 items and 21,887 data fields), and gave excellent results provided use of highly structured questionnaires. OMR performed equally as well as manual double-key entering, and better than single-key entering. The PRO translation and validation study included 2,278 patients (and 212 patients for the test

  14. Incomplete Reporting: Addressing the Prevalence of Outcome-Reporting Bias in Educational Research

    ERIC Educational Resources Information Center

    Trainor, Brian; Polanin, Joshua; Williams, Ryan; Pigott, Terri

    2015-01-01

    Outcome reporting bias refers to the practice of omitting from primary studies outcomes that were actually collected. When primary studies do not report on all the outcomes assessed, there is an incomplete understanding of a phenomenon that may be compounded when the study is included in a systematic review of research. Outcome reporting bias is…

  15. Concordance of adherence measurement using self-reported adherence questionnaires and medication monitoring devices.

    PubMed

    Shi, Lizheng; Liu, Jinan; Koleva, Yordanka; Fonseca, Vivian; Kalsekar, Anupama; Pawaskar, Manjiri

    2010-01-01

    The primary objective of this review was to identify and examine the literature on the association between medication adherence self-reported questionnaires (SRQs) and medication monitoring devices. The primary literature search was performed for 1980-2009 using PubMed, PubMed In Process and Non-Indexed, Ovid MEDLINE, Ovid MEDLINE In-Process, PsycINFO (EBSCO), CINAHL (EBSCO), Ovid HealthStar, EMBASE (Elsevier) and Cochrane Databases and using the following search terms: 'patient compliance', 'medication adherence', 'treatment compliance', 'drug monitoring', 'drug therapy', 'electronic', 'digital', 'computer', 'monitor', 'monitoring', 'drug', 'drugs', 'pharmaceutical preparations', 'compliance' and 'medications'. We identified studies that included SRQs and electronic monitoring devices to measure adherence and focused on the SRQs that were found to be moderately to highly correlated with the monitoring devices. Of the 1679 citations found via the primary search, 41 full-text articles were reviewed for correlation between monitoring devices and SRQs. A majority (68%) of articles reported high (27%), moderate (29%) or significant (12%) correlation between monitoring devices (37 using Medication Event Monitoring System [MEMS®] and four using other devices) and SRQs (11 identified and numerous other unnamed SRQs). The most commonly used SRQs were the Adult/Pediatric AIDS Clinical Trial Group (AACTG/PACTG; 24.4%, 10/41) followed by the 4-item Morisky (9.8%, 4/41), Brief Medication Questionnaire (9.8%, 4/41) and visual analogue scale (VAS; 7.3%, 3/41). Although study designs differed across the articles, SRQs appeared to report a higher rate of medication adherence (+14.9%) than monitoring devices. In conclusion, several medication adherence SRQs were validated using electronic monitoring devices. A majority of them showed high or moderate correlation with medication adherence measured using monitoring devices, and could be considered for measuring patient-reported

  16. Questionnaire for Persons with a Transfemoral Amputation (Q-TFA): initial validity and reliability of a new outcome measure.

    PubMed

    Hagberg, Kerstin; Brånemark, Rickard; Hägg, Olle

    2004-09-01

    The Questionnaire for Persons with a Transfemoral Amputation (Q-TFA) is a new self-report measure developed for nonelderly transfemoral amputees using a socket- or osseointegrated prosthesis to reflect use, mobility, problems, and global health, each in a separate score (0-100). This paper describes the initial measurement properties of the Q-TFA as completed by 156 persons with a transfemoral amputation using a socket prosthesis (67% male, 92% nonvascular cases, mean age 51 years). Criterion validity was determined by associations between scores of the Q-TFA and the Short-Form 36 (SF-36)-Item Health Survey. Reliability was assessed by retest (n = 48) and by determination of the internal consistency. Correlations between Q-TFA and SF-36-Item Health Survey scales matched hypothesized patterns. Intraclass correlations were between 0.89 and 0.97, and measurement error ranged from 10 to 19 points. Cronbach's alpha revealed good internal consistency, with no values less than 0.7. This study shows that the Q-TFA, applied to persons using a transfemoral socket prosthesis, has adequate initial validity and reliability.

  17. Psychometric properties of the Arabic self-report version of the strengths and difficulties questionnaire.

    PubMed

    Emam, Mahmoud Mohamed; Abu Hilal, Maher M; Kazem, Ali Mahdi; Alkharousi, Suad Juma

    2016-12-01

    Students in middle school tend to display emotional and behavioural difficulties (EBDs) compared to other forms of psychopathology. Early identification of EBDs is therefore a priority in order to prevent the chronic co-morbidity with other forms of psychopathology which may affect students' academic achievement. Assessment of EBDs has been traditionally undertaken via proxy reporting; but psychometrically rigorous instruments are needed so that children and adolescents can report on their own emotions and behaviours. Such need increases in the Omani context given the lack of EBDs adequate assessment instruments. In the current study the factor structure of the Arabic self-report version of the Strengths and Difficulties Questionnaire (A-SDQ) was examined in a sample of 815 middle school students (mean age=14 years). The study tested the SDQ original five-factor model which received considerable empirical support. Responses on the A-SDQ were compared to responses obtained via proxy reports from teachers and parents through confirmatory factor analyses (CFAs). Results showed a reasonable fit for the three informant forms. Nevertheless, there were differences in item loadings across the three informant forms. Additionally, participants' self-report responses were tested for invariance across gender. CFAs provided support to the invariance hypothesis for item loadings, indicating that the items were similarly valid indices of the five factors for males and females. Factor correlations, factor variances and item residuals were not invariant across gender.

  18. Critical Limb Ischemia: Reporting Outcomes and Quality

    PubMed Central

    2012-01-01

    The impetus to pursue quality in limb salvage is high in the current economic environment. This has been spurred on by the diffusion of multiple technologies, the lack of well-defined cost-effectiveness benchmarks, and the paucity of process and structure benchmarks. Furthermore, no national database exists to capture current activity and trends, and lead structure and process changes that could analyze outcomes and improve standards in peripheral interventions for limb salvage. This manuscript examines the challenges in measuring outcomes and quality in limb salvage and explores the components necessary for ensuring quality in limb salvage interventions. PMID:23342183

  19. Colorado Learning Difficulties Questionnaire: validation of a parent-report screening measure.

    PubMed

    Willcutt, Erik G; Boada, Richard; Riddle, Margaret W; Chhabildas, Nomita; DeFries, John C; Pennington, Bruce F

    2011-09-01

    This study evaluated the internal structure and convergent and discriminant evidence for the Colorado Learning Difficulties Questionnaire (CLDQ), a 20-item parent-report rating scale that was developed to provide a brief screening measure for learning difficulties. CLDQ ratings were obtained from parents of children in 2 large community samples and 2 samples from clinics that specialize in the assessment of learning disabilities and related disorders (total N = 8,004). Exploratory and confirmatory factor analyses revealed 5 correlated but separable dimensions that were labeled reading, math, social cognition, social anxiety, and spatial difficulties. Results revealed strong convergent and discriminant evidence for the CLDQ Reading scale, suggesting that this scale may provide a useful method to screen for reading difficulties in both research studies and clinical settings. Results are also promising for the other 4 CLDQ scales, but additional research is needed to refine each of these measures.

  20. Colorado Learning Difficulties Questionnaire:Validation of a parent-report screening measure

    PubMed Central

    Willcutt, Erik G.; Boada, Richard; Riddle, Margaret W.; Chhabildas, Nomita; DeFries, John C.; Pennington, Bruce F.

    2011-01-01

    This study evaluated the internal structure and convergent and discriminant evidence for the Colorado Learning Difficulties Questionnaire (CLDQ), a 20-item parent-report rating scale that was developed to provide a brief screening measure for learning difficulties. CLDQ ratings were obtained from parents of children in two large community samples and two samples from clinics that specialize in the assessment of learning disabilities and related disorders (total N = 8,004). Exploratory and confirmatory factor analyses revealed five correlated but separable dimensions that were labeled reading, math, social cognition, social anxiety, and spatial difficulties. Results revealed strong convergent and discriminant evidence for the CLDQ Reading scale, suggesting that this scale may provide a useful method to screen for reading difficulties in both research studies and clinical settings. Results are also promising for the other four CLDQ scales, but additional research is needed to refine each of these measures. PMID:21574721

  1. Psychometric Properties of the Self-Report Version of the Strengths and Difficulties Questionnaire in Korea

    PubMed Central

    Kim, Min-Hyuk; Min, Seongho

    2015-01-01

    Objective To examine the reliability and validity of the self-report Korean version of Strengths and Difficulties Questionnaire (SDQ-Kr) in the community sample. Methods The SDQ-Kr was administered to a large sample of school children and adolescents (n=2814) and youth attendees of a psychiatric clinic (n=385) aged 11-16 years. To examine temporal stability, the same questionnaire was administered to a subsample of 167 school youths five to six weeks after the initial assessment. To examine the reliability, we calculated Cronbach's alpha coefficients for internal consistency and Pearson's correlations for test-retest stability. In order to evaluate the factorial structure of the SDQ-Kr items, we conducted an exploratory factor analysis (EFA) with varimax rotation. Finally, discriminant validity was examined by using receiver operating characteristic (ROC) curves employing the area under the curve (AUC) as an index of discriminant ability. Results Although the internal consistency of some subscales of the SDQ-Kr was somewhat less satisfactory (alpha coefficients; 0.28-0.54) than the English original, coefficients for the total difficulties scores approached sufficient levels (coefficients; 0.69). Other psychometric properties including discriminant validity (AUC for total difficulties and four subscales >0.7) were comparable to those obtained in other language studies. Conclusion The self-report SDQ-Kr exhibited a low level of reliability, indicating that some items need to be further evaluated and revised to improve the psychometric properties. We suggest that the total difficulties score could be used with more confidence for screening possible mental health problems in youths. PMID:26508960

  2. The Walking Speed Questionnaire: Assessing Walking Speed in a Self-Reported Format

    PubMed Central

    Cong, Guang-Ting; Cohn, Matthew R.; Villa, Jordan; Kerwin, Lewis J.; Rosen, Natalie; Fang, Xiu Zhen; Christos, Paul J.; Evrony, Ayelet; Chen, Jin; Torres, Ashley; Lane, Joseph M.

    2015-01-01

    STRUCTURED ABSTRACT OBJECTIVES The literature increasingly demonstrates the importance of gait speed in the frailty assessment of patients 60 years and older. Conventional gait speed measurement, however, may be contraindicated in settings such as trauma where the patient is temporarily immobilized. We devised a Walking Speed Questionnaire (WSQ) to allow assessment of pre-injury baseline gait speed, in meters per second, in a self-reported manner, to overcome the inability to directly test the patients’ walking speed. DESIGN Four questions comprise the WSQ, and were derived using previously published questionnaires and expert opinion of six physician-researchers. SETTING Four ambulatory clinics. PARTICIPANTS Ambulating individuals aged 60 to 95 (mean age 73.2 ± 8.1, 86.1% female, N = 101). INTERVENTION Participants completed the WSQ and underwent gait speed measurement for comparison. ANALYSIS WSQ score correlation to true gait speed, receiver operating characteristics, and validation statistics were performed. RESULTS All four questions of the WSQ independently predicted true gait speed significantly (P<0.001). The WSQ sufficiently predicted true gait speed with r = 0.696 and ρ = 0.717. CONCLUSION The WSQ is an effective tool for assessing baseline walking speed in patients 60 years and older in a self-reported manner. It permits gait screening in health care environments where conventional gait speed testing is contraindicated due to temporary immobilization, and may be used to provide baseline targets for goal-oriented post-trauma care. Given its ability to capture gait speed in patients who are unable to ambulate, it may open doors for frailty research in previously unattainable populations. PMID:26569186

  3. Diagnostic accuracy for major depression in multiple sclerosis using self-report questionnaires

    PubMed Central

    Fischer, Anja; Fischer, Marcus; Nicholls, Robert A; Lau, Stephanie; Poettgen, Jana; Patas, Kostas; Heesen, Christoph; Gold, Stefan M

    2015-01-01

    Objective Multiple sclerosis and major depressive disorder frequently co-occur but depression often remains undiagnosed in this population. Self-rated depression questionnaires are a good option where clinician-based standardized diagnostics are not feasible. However, there is a paucity of data on diagnostic accuracy of self-report measures for depression in multiple sclerosis (MS). Moreover, head-to-head comparisons of common questionnaires are largely lacking. This could be particularly relevant for high-risk patients with depressive symptoms. Here, we compare the diagnostic accuracy of the Beck Depression Inventory (BDI) and 30-item version of the Inventory of Depressive Symptomatology Self-Rated (IDS-SR30) for major depressive disorder (MSS) against diagnosis by a structured clinical interview. Methods Patients reporting depressive symptoms completed the BDI, the IDS-SR30 and underwent diagnostic assessment (Mini International Neuropsychiatric Interview, M.I.N.I.). Receiver-Operating Characteristic analyses were performed, providing error estimates and false-positive/negative rates of suggested thresholds. Results Data from n = 31 MS patients were available. BDI and IDS-SR30 total score were significantly correlated (r = 0.82). The IDS-SR30total score, cognitive subscore, and BDI showed excellent to good accuracy (area under the curve (AUC) 0.86, 0.91, and 0.85, respectively). Conclusion Both the IDS-SR30 and the BDI are useful to quantify depressive symptoms showing good sensitivity and specificity. The IDS-SR30 cognitive subscale may be useful as a screening tool and to quantify affective/cognitive depressive symptomatology. PMID:26445703

  4. Self-reported symptoms associated with exposure to electromagnetic fields: a questionnaire study.

    PubMed

    Küçer, Nermin; Pamukçu, Tuğba

    2014-01-01

    Abstract In the last years, it has been discussed frequently whether there are any harmful effects of electromagnetic fields on human health. Electromagnetic fields are generated by several natural and man-made sources. Part of the electromagnetic spectrum called Radiofrequency is used in communication systems such as mobile (cellular) phone and computer. The aim of our study was to explore different self-reported symptoms that may be associated with exposure to electromagnetic fields. This survey study was conducted, using a questionnaire, on 350 people aged +9 years in Turkey. The chi-square test was used for data analysis. Self-reported symptoms were headache, vertigo/dizziness, fatigue, forgetfulness, sleep disturbance-insomnia, tension-anxiety, joint and bone pain, lacrimation of the eyes, hearing loss and tinnitus. As a result of the survey, the study has shown that users of mobile phone and computer more often complained of headache, joint and bone pain, hearing loss, vertigo/dizziness, tension-anxiety symptoms according to time of daily usage (p < 0.05). In users of mobile phone and computer, women significantly (p < 0.05) complained more often of headache, vertigo/dizziness, fatigue, forgetfulness and tension-anxiety than men.

  5. Reporting questionnaire for children as a screening instrument for child mental health problems in Iraqi Kurdistan.

    PubMed

    Ahmad, Abdulbaghi; Abdul-Majeed, Anas M; Siddiq, Aras A; Jabar, Fatima; Qahar, Jabar; Rasheed, Jihan; von Knorring, Anne-Liis

    2007-03-01

    To identify child mental health problems in a mid-sized to large city in Iraqi Kurdistan, the Reporting Questionnaire for Children (RQC), followed by the Child Behaviour Checklist (CBCL) and the Post-traumatic Stress Symptom Checklist for Children (PTSS-C), were administered in interview form to the caregivers of 806 school-aged children. To cover different categories of children, four samples were randomly selected from among the general population (n = 201), orphans (n = 241), primary medical care patients (n = 199), and hospital patients (n = 165). The RQC revealed satisfactory validity against a deviant CBCL cut-off. The screening capacity of the RQC was further supported by its similarity to the CBCL in distribution of problem scores among the four samples and its positive correlation with the CBCL, but not with the trauma-related PTSS-C. Although the general population showed lower problem scores than the orphans and the two clinical samples, problem scores in all instruments were considerably higher than those reported from other societies. The RQC seems to be useful as a first-stage screening instrument for child mental health problems in Kurdistan.

  6. Development and Validation of a Self-Report Measure of Mentalizing: The Reflective Functioning Questionnaire

    PubMed Central

    Fonagy, Peter; Luyten, Patrick; Moulton-Perkins, Alesia; Lee, Ya-Wen; Warren, Fiona; Howard, Susan; Ghinai, Rosanna; Fearon, Pasco; Lowyck, Benedicte

    2016-01-01

    Reflective functioning or mentalizing is the capacity to interpret both the self and others in terms of internal mental states such as feelings, wishes, goals, desires, and attitudes. This paper is part of a series of papers outlining the development and psychometric features of a new self-report measure, the Reflective Functioning Questionnaire (RFQ), designed to provide an easy to administer self-report measure of mentalizing. We describe the development and initial validation of the RFQ in three studies. Study 1 focuses on the development of the RFQ, its factor structure and construct validity in a sample of patients with Borderline Personality Disorder (BPD) and Eating Disorder (ED) (n = 108) and normal controls (n = 295). Study 2 aims to replicate these findings in a fresh sample of 129 patients with personality disorder and 281 normal controls. Study 3 addresses the relationship between the RFQ, parental reflective functioning and infant attachment status as assessed with the Strange Situation Procedure (SSP) in a sample of 136 community mothers and their infants. In both Study 1 and 2, confirmatory factor analyses yielded two factors assessing Certainty (RFQ_C) and Uncertainty (RFQ_U) about the mental states of self and others. These two factors were relatively distinct, invariant across clinical and non-clinical samples, had satisfactory internal consistency and test–retest stability, and were largely unrelated to demographic features. The scales discriminated between patients and controls, and were significantly and in theoretically predicted ways correlated with measures of empathy, mindfulness and perspective-taking, and with both self-reported and clinician-reported measures of borderline personality features and other indices of maladaptive personality functioning. Furthermore, the RFQ scales were associated with levels of parental reflective functioning, which in turn predicted infant attachment status in the SSP. Overall, this study lends

  7. Alternative Learning Programs Evaluation: Part 2 Report. Outcomes.

    ERIC Educational Resources Information Center

    North Carolina State Dept. of Public Instruction, Raleigh. Div. of Accountability Services/Research.

    In 1996, North Carolina began a 5-year evaluation of Alternative Learning Programs (ALPs). This report describes selected outcomes for students who participated in ALPs during 1995-96. These outcomes include performance on North Carolina End-of-Grade tests (elementary school) and performance on the End-of-Course(EOC) tests (high school) for…

  8. Toward Ensuring Health Equity: Readability and Cultural Equivalence of OMERACT Patient-reported Outcome Measures

    PubMed Central

    Petkovic, Jennifer; Epstein, Jonathan; Buchbinder, Rachelle; Welch, Vivian; Rader, Tamara; Lyddiatt, Anne; Clerehan, Rosemary; Christensen, Robin; Boonen, Annelies; Goel, Niti; Maxwell, Lara J.; Toupin-April, Karine; De Wit, Maarten; Barton, Jennifer; Flurey, Caroline; Jull, Janet; Barnabe, Cheryl; Sreih, Antoine G.; Campbell, Willemina; Pohl, Christoph; Duruöz, Mehmet Tuncay; Singh, Jasvinder A.; Tugwell, Peter S.; Guillemin, Francis

    2016-01-01

    Objective The goal of the Outcome Measures in Rheumatology (OMERACT) 12 (2014) equity working group was to determine whether and how comprehensibility of patient-reported outcome measures (PROM) should be assessed, to ensure suitability for people with low literacy and differing cultures. Methods The English, Dutch, French, and Turkish Health Assessment Questionnaires and English and French Osteoarthritis Knee and Hip Quality of Life questionnaires were evaluated by applying 3 readability formulas: Flesch Reading Ease, Flesch-Kincaid grade level, and Simple Measure of Gobbledygook; and a new tool, the Evaluative Linguistic Framework for Questionnaires, developed to assess text quality of questionnaires. We also considered a study assessing cross-cultural adaptation with/without back-translation and/or expert committee. The results of this preconference work were presented to the equity working group participants to gain their perspectives on the importance of comprehensibility and cross-cultural adaptation for PROM. Results Thirty-one OMERACT delegates attended the equity session. Twenty-six participants agreed that PROM should be assessed for comprehensibility and for use of suitable methods (4 abstained, 1 no). Twenty-two participants agreed that cultural equivalency of PROM should be assessed and suitable methods used (7 abstained, 2 no). Special interest group participants identified challenges with cross-cultural adaptation including resources required, and suggested patient involvement for improving translation and adaptation. Conclusion Future work will include consensus exercises on what methods are required to ensure PROM are appropriate for people with low literacy and different cultures. PMID:26077410

  9. Patient-reported outcome measures in burning mouth syndrome - a review of the literature.

    PubMed

    Ni Riordain, R; McCreary, C

    2013-04-01

    Oral Diseases (2013) 19, 230-235 This review aims to investigate the patient-reported outcomes currently used in the burning mouth syndrome literature and to explore whether any standardisation of such measures has taken place. Electronic databases were searched for all types of burning mouth syndrome studies using patient-reported outcome measures. Studies were selected by predefined inclusion criteria. Copies of the papers obtained were thoroughly reviewed. A study-specific data extraction form was used, allowing papers to be reviewed in a standardised manner. The initial literature search yielded a total of 173 citations, 43 of which were deemed suitable for inclusion in this study. Symptom severity and symptomatic relief were reported as a patient-reported outcome measure in 40 of the studies and quantified most commonly using a visual analogue scale. Quality of life was reported in 13 studies included in this review. Depression and/or anxiety was reported in 14 of the studies. As is evident from the variety of questionnaires and instruments used in the evaluation of the impact of burning mouth syndrome on patients' lives, no standardisation of patient outcomes has yet been achieved.

  10. The Derivation of Job Compensation Index Values from the Position Analysis Questionnaire (PAQ). Report No. 6.

    ERIC Educational Resources Information Center

    McCormick, Ernest J.; And Others

    The study deals with the job component method of establishing compensation rates. The basic job analysis questionnaire used in the study was the Position Analysis Questionnaire (PAQ) (Form B). On the basis of a principal components analysis of PAQ data for a large sample (2,688) of jobs, a number of principal components (job dimensions) were…

  11. Does participation in an intervention affect responses on self-report questionnaires?

    PubMed

    Baranowski, Tom; Allen, Diane D; Mâsse, Louise C; Wilson, Mark

    2006-12-01

    There has been some concern that participation in an intervention and exposure to a measurement instrument can change participants' interpretation of the items on a self-report questionnaire thereby distorting subsequent responses and biasing results. Differential item functioning (DIF) analysis using item response modeling can ascertain possible differences in item interpretation by testing for differences in item location between groups. The DIF for treatment versus control group differences at post-intervention assessment and the Time 1 and Time 2 differences in a control group were analyzed using data from a dietary change intervention trial for Boy Scouts. The measures included fruit and vegetable (FV) frequency of consumption, preferences and self-efficacy. Treatment-control group DIF at post-intervention assessment was detected in a higher percentage of items for FV frequency than for preference or self-efficacy. Time 1 to Time 2 differences in items for the control group were detected in one item for each of the three scales. Further research will need to clarify whether the obtained DIFs reflected true changes in frequency, preference or self-efficacy or some reinterpretation of items by participants following an intervention or merely after previous exposure to the measure.

  12. Examining the validity of the adapted Alabama Parenting Questionnaire-Parent Global Report Version.

    PubMed

    Maguin, Eugene; Nochajski, Thomas H; De Wit, David J; Safyer, Andrew

    2016-05-01

    The purpose of the present study was to comprehensively examine the validity of an adapted version of the parent global report form of the Alabama Parenting Questionnaire (APQ) with respect to its factor structure, relationships with demographic and response style covariates, and differential item functioning (DIF). The APQ was adapted by omitting the corporal punishment and the other discipline items. The sample consisted of 674 Canadian and United States families having a 9- to 12-year-old child and at least 1 parent figure who had received treatment within the past 5 years for alcohol problems or met criteria for alcohol abuse or dependence. The primary parent in each family completed the APQ. The 4-factor CFA model of the 4 published scales used and the 3-factor CFA model of those scales from prior research were rejected. Exploratory structural equation modeling was then used. The final 3-factor model combined the author-defined Involvement and Positive Parenting scales and retained the original Poor Monitoring/Supervision and Inconsistent Discipline scales. However, there were substantial numbers of moderate magnitude cross-loadings and large magnitude residual covariances. Differential item functioning (DIF) was observed for a number of APQ items. Controlling for DIF, response style and demographic variables were related significantly to the factors. (PsycINFO Database Record

  13. Internal consistency of the self-reporting questionnaire-20 in occupational groups

    PubMed Central

    Santos, Kionna Oliveira Bernardes; Carvalho, Fernando Martins; de Araújo, Tânia Maria

    2016-01-01

    ABSTRACT OBJECTIVE To assess the internal consistency of the measurements of the Self-Reporting Questionnaire (SRQ-20) in different occupational groups. METHODS A validation study was conducted with data from four surveys with groups of workers, using similar methods. A total of 9,959 workers were studied. In all surveys, the common mental disorders were assessed via SRQ-20. The internal consistency considered the items belonging to dimensions extracted by tetrachoric factor analysis for each study. Item homogeneity assessment compared estimates of Cronbach’s alpha (KD-20), the alpha applied to a tetrachoric correlation matrix and stratified Cronbach’s alpha. RESULTS The SRQ-20 dimensions showed adequate values, considering the reference parameters. The internal consistency of the instrument items, assessed by stratified Cronbach’s alpha, was high (> 0.80) in the four studies. CONCLUSIONS The SRQ-20 showed good internal consistency in the professional categories evaluated. However, there is still a need for studies using alternative methods and additional information able to refine the accuracy of latent variable measurement instruments, as in the case of common mental disorders. PMID:27007682

  14. Psychological mindedness as a predictor of psychotherapy outcome: a preliminary report.

    PubMed

    Conte, H R; Plutchik, R; Jung, B B; Picard, S; Karasu, T B; Lotterman, A

    1990-01-01

    This study investigated the properties of a new measure of psychological mindness (PM). A 45-item self-report questionnaire was administered to consecutive admissions to a large outpatient clinic that provides primarily psychodynamically oriented individual psychotherapy. The PM scores of a sample of 44 of these patients who attended a median of 15 sessions were correlated with several outcome measures obtained from retrospective chart reviews. These measures consisted of the number of sessions attended, discharge ratings, and change scores on a Global Assessment Scale (GAS) and on a symptom checklist. Coefficient alpha for the Psychological Mindedness (PM) Scale indicated high reliability. Total PM score correlated significantly with three of the outcome measures. Twenty of the 45-items were good predictors of one or more outcome measures.

  15. 2013 Alaska Performance Scholarship Outcomes Report

    ERIC Educational Resources Information Center

    Rae, Brian

    2013-01-01

    In accordance with Alaska statute the departments of Education & Early Development (EED) and Labor and Workforce Development (DOLWD), the University of Alaska (UA), and the Alaska Commission on Postsecondary Education (ACPE) present this second annual report on the Alaska Performance Scholarship (APS). Among the highlights: (1) In the public…

  16. 2012 Alaska Performance Scholarship Outcomes Report

    ERIC Educational Resources Information Center

    Rae, Brian

    2012-01-01

    As set forth in Alaska Statute 14.43.840, Alaska's Departments of Education & Early Development (EED) and Labor and Workforce Development (DOLWD), the University of Alaska (UA), and the Alaska Commission on Postsecondary Education (ACPE) present this first annual report on the Alaska Performance Scholarship to the public, the Governor, and the…

  17. A randomized controlled trial of patient-reported outcomes with tai chi exercise in Parkinson's disease.

    PubMed

    Li, Fuzhong; Harmer, Peter; Liu, Yu; Eckstrom, Elizabeth; Fitzgerald, Kathleen; Stock, Ronald; Chou, Li-Shan

    2014-04-01

    A previous randomized, controlled trial of tai chi showed improvements in objectively measured balance and other motor-related outcomes in patients with Parkinson's disease. This study evaluated whether patient-reported outcomes could be improved through exercise interventions and whether improvements were associated with clinical outcomes and exercise adherence. In a secondary analysis of the tai chi trial, patient-reported and clinical outcomes and exercise adherence measures were compared between tai chi and resistance training and between tai chi and stretching exercise. Patient-reported outcome measures were perceptions of health-related benefits resulting from participation, assessed by the Parkinson's Disease Questionnaire (PDQ-8) and Vitality Plus Scale (VPS). Clinical outcome measures included motor symptoms, assessed by a modified Unified Parkinson's Disease Rating Scale-Motor Examination (UPDRS-ME) and a 50-foot speed walk. Information on continuing exercise after the structured interventions were terminated was obtained at a 3-month postintervention follow-up. Tai chi participants reported significantly better improvement in the PDQ-8 (-5.77 points, P = 0.014) than did resistance training participants and in PDQ-8 (-9.56 points, P < 0.001) and VPS (2.80 points, P = 0.003) than did stretching participants. For tai chi, patient-reported improvement in the PDQ-8 and VPS was significantly correlated with their clinical outcomes of UPDRS-ME and a 50-foot walk, but these correlations were not statistically different from those shown for resistance training or stretching. However, patient-reported outcomes from tai chi training were associated with greater probability of continued exercise behavior than were either clinical outcomes or patient-reported outcomes from resistance training or stretching. Tai chi improved patient-reported perceptions of health-related benefits, which were found to be associated with a greater probability of exercise

  18. Relationship Between Hospital Financial Performance and Publicly Reported Outcomes

    PubMed Central

    Nguyen, Oanh Kieu; Halm, Ethan A.; Makam, Anil N.

    2017-01-01

    Background Hospitals that have robust financial performance may have improved publicly reported outcomes. Objectives To assess the relationship between hospital financial performance and publicly reported outcomes of care, and to assess whether improved outcome metrics affect subsequent hospital financial performance. Design Observational cohort study. Setting And Patients Hospital financial data from the Office of Statewide Health Planning and Development in California in 2008 and 2012 were linked to data from the Centers for Medicare and Medicaid Services Hospital Compare website. Measurements Hospital financial performance was measured by net revenue by operations, operating margin, and total margin. Outcomes were 30-day risk-standardized mortality and readmission rates for acute myocardial infarction (AMI), congestive heart failure (CHF), and pneumonia (PNA). Results Among 279 hospitals, there was no consistent relationship between measures of financial performance in 2008 and publicly reported outcomes from 2008 to 2011 for AMI and PNA. However, improved hospital financial performance (by any of the 3 measures) was associated with a modest increase in CHF mortality rates (ie, 0.26% increase in CHF mortality rate for every 10% increase in operating margin [95% confidence interval: 0.07%-0.45%]). Conversely, there were no significant associations between outcomes from 2008 to 2011 and subsequent financial performance in 2012 (P > 0.05 for all). Conclusions Robust financial performance is not associated with improved publicly reported outcomes for AMI, CHF, and PNA. Financial incentives in addition to public reporting, such as readmissions penalties, may help motivate hospitals with robust financial performance to further improve publicly reported outcomes. Reassuringly, improved mortality and readmission rates do not necessarily lead to loss of revenue. PMID:26929094

  19. Patient-Reported Outcomes and Fibromyalgia.

    PubMed

    Williams, David A; Kratz, Anna L

    2016-05-01

    Fibromyalgia (FM) is classified as a chronic pain condition accompanied by symptoms of fatigue, sleep problems, problems with cognition, negative mood, limited functional status, and the presence of other chronic overlapping pain conditions. Comprehensive assessment of all of these components can be challenging. This paper provides an overview of patient-reported approaches that can be taken to assess FM in the contexts of diagnosis, symptom monitoring, phenotyping/characterization, and for purposes of clinical trials.

  20. Comparing Self-Report Measures of Internalized Weight Stigma: The Weight Self-Stigma Questionnaire versus the Weight Bias Internalization Scale

    PubMed Central

    Hübner, Claudia; Schmidt, Ricarda; Selle, Janine; Köhler, Hinrich; Müller, Astrid; de Zwaan, Martina; Hilbert, Anja

    2016-01-01

    Background Internalized weight stigma has gained growing interest due to its association with multiple health impairments in individuals with obesity. Especially high internalized weight stigma is reported by individuals undergoing bariatric surgery. For assessing this concept, two different self-report questionnaires are available, but have never been compared: the Weight Self-Stigma Questionnaire (WSSQ) and the Weight Bias Internalization Scale (WBIS). The purpose of the present study was to provide and to compare reliability, convergent validity with and predictive values for psychosocial health outcomes for the WSSQ and WBIS. Methods The WSSQ and the WBIS were used to assess internalized weight stigma in N = 78 prebariatric surgery patients. Further, body mass index (BMI) was assessed and body image, quality of life, self-esteem, depression, and anxiety were measured by well-established self-report questionnaires. Reliability, correlation, and regression analyses were conducted. Results Internal consistency of the WSSQ was acceptable, while good internal consistency was found for the WBIS. Both measures were significantly correlated with each other and body image. While only the WSSQ was correlated with overweight preoccupation, only the WBIS was correlated with appearance evaluation. Both measures were not associated with BMI. However, correlation coefficients did not differ between the WSSQ and the WBIS for all associations with validity measures. Further, both measures significantly predicted quality of life, self-esteem, depression, and anxiety, while the WBIS explained significantly more variance than the WSSQ total score for self-esteem. Conclusions Findings indicate the WSSQ and the WBIS to be reliable and valid assessments of internalized weight stigma in prebariatric surgery patients, although the WBIS showed marginally more favorable results than the WSSQ. For both measures, longitudinal studies on stability and predictive validity are warranted, for

  1. [Utility of the questionnaire for quality of life EORTC-QLQ-C30 in psycho-oncological outcome research].

    PubMed

    Determann, M M; Kollenbaum, V-E; Henne-Bruns, D

    2004-01-01

    Aim of this paper is to examine the utility and validity of the questionnaire for quality of life EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer). Data were collected within the scope of a study for evaluation of individual psycho-oncological support for inpatients with colorectal cancer undergoing surgery. The study was sponsored by the German Cancer Aid. The design was a prospective randomized controlled trial. After informed consent, patients were randomized in one of two groups: patients in the experimental group received individualized psychotherapeutic support during the hospital stay; those in the control group received a daily program of classical music. All patients were assessed one day before surgical treatment, ten days and three months after surgery. Instruments were questionnaires for quality of life and state anxiety. 106 patients met the inclusion criteria. Results show insufficient discriminative power (high significant bivariate correlations between most EORTC scales, Kendalls tau-b) and insufficient construct validity (high and significant bivariate correlations between most EORTC scales and state anxiety, Kendalls tau-b) of the EORTC scales. The scores of "cognitive functioning" and some symptom scales show an insufficient scatter. The illustration of situational influences and therefore an insufficient illustration of effects of specific interventions are connected with a high sensitivity of the scales and a tendency to extreme sores. The psycho-oncological intervention shows a significant stress reducing effect on the specific EORTC-scale "Emotional Functioning" and on State Anxiety (STAI). The testing of utility and validity of the EORTC-Questionnaire shows that they are insufficient and therefore the benefit for evaluation of specific intervention procedures is restricted.

  2. Self-reported injuries among seafarers. Questionnaire validity and results from an international study.

    PubMed

    Jensen, Olaf C; Sørensen, Jens F L; Kaerlev, Linda; Canals, M Luisa; Nikolic, Nebojsa; Saarni, Heikki

    2004-05-01

    International surveys of occupational injuries among seafarers have so far been missing. It was the aim to test the method of self-report of injuries and length of time at risk during the latest duty period and second to study the injury incidence rate among seafarers by use of the method. A pilot study was conducted (n = 1068) in Finland, Denmark, the Philippines, Croatia and Spain using self-completed questionnaires with questions about the person, the ship, the duration of latest duty period and injuries. The duration of the self-reporting duty period was in the Danish part compared with information from the crew register of the Maritime Authority. For seafarers from merchant ships in the Danish sub-study there was acceptable correspondence between the information from the seafarers and the Maritime Authority, but not when referring to ferries and non-specified types of ship. Unadjusted and adjusted injury incidence rates-ratios (IRRs) based on number of injuries per number of work hours were calculated. Adjusted IRRs for ordinary seamen/officers: IRR = 2.43 (95% CI: 1.25-4.72); for age < 35/35+ years: IRR = 1.97 (1.02-3.81); length of tour: 117 days or longer compared with < 117 days: IRR = 0.46 (95% CI: 0.22-0.95); 57-70 working hours per week compared with < 57 h: IRR = 1.26 (0.48-3.29), 71+h compared with < 57 h: IRR = 2.12 (0.84-5.36). Non-significant IRRs >1.00 were found for ships under 10,000 GT compared with larger ships and for own flagged ships compared with ships under flag of convenience. In conclusion, more than 70 h of work per week was related to a higher rate of injuries for seafarers on merchant ships, but the result was not statistically significant. Self-report of the duration of the latest tour of duty is useful for seafarers from merchant ships with short-term employments, but not for ferries and other, non-specified types of ship with other or permanent employment.

  3. Observation versus self-report: validation of a consumer food behavior questionnaire.

    PubMed

    Kendall, Patricia A; Elsbernd, Anne; Sinclair, Kelly; Schroeder, Mary; Chen, Gang; Bergmann, Verna; Hillers, Virginia N; Medeiros, Lydia C

    2004-11-01

    A reliable and validated set of food safety behavior questions that could be used with confidence when evaluating food safety education programs was identified in this study. A list of 29 food-handling and consumption behaviors rank-ordered within five pathogen control factors by nationally recognized food safety experts was the basis for the development of the behavior questions. Questions were evaluated for reliability and several forms of validity. During a kitchen activity session, 70 graduates of a nutrition education program completed four food preparation tasks while being observed and videotaped. The individuals also participated in an in-depth interview to validate behaviors that could not be observed during the food preparation activity, e.g., refraining from preparing food for others when experiencing diarrhea. Criterion validity was established by comparing questionnaire responses to observed behavior and interview responses. Twenty-eight questions met the validity criterion (> or = 70% agreement between observed and interviewed responses and self-reported responses), with three or more questions from each of five pathogen control factor areas. Observation assessments revealed that hand washing was more likely to be performed prior to beginning food preparation than between working with raw meats and fresh produce. Errors in methods of washing hands, utensils, and preparation surfaces between food preparation tasks were common. Most participants did not use thermometers to evaluate doneness but still cooked to safe internal temperatures. The results provide a tool that educators can use to evaluate food safety programs and will help guide the development of more effective food safety education programs targeting needed improvements in behavioral skills.

  4. The Bipolar II Depression Questionnaire: A Self-Report Tool for Detecting Bipolar II Depression

    PubMed Central

    Leung, Chi Ming; Yim, Chi Lap; Yan, Connie T. Y.; Chan, Cheuk Chi; Xiang, Yu-Tao; Mak, Arthur D. P.; Fok, Marcella Lei-Yee; Ungvari, Gabor S.

    2016-01-01

    Bipolar II (BP-II) depression is often misdiagnosed as unipolar (UP) depression, resulting in suboptimal treatment. Tools for differentiating between these two types of depression are lacking. This study aimed to develop a simple, self-report screening instrument to help distinguish BP-II depression from UP depressive disorder. A prototype BP-II depression questionnaire (BPIIDQ-P) was constructed following a literature review, panel discussions and a field trial. Consecutively assessed patients with a diagnosis of depressive disorder or BP with depressive episodes completed the BPIIDQ-P at a psychiatric outpatient clinic in Hong Kong between October and December 2013. Data were analyzed using discriminant analysis and logistic regression. Of the 298 subjects recruited, 65 (21.8%) were males and 233 (78.2%) females. There were 112 (37.6%) subjects with BP depression [BP-I = 42 (14.1%), BP-II = 70 (23.5%)] and 182 (62.4%) with UP depression. Based on family history, age at onset, postpartum depression, episodic course, attacks of anxiety, hypersomnia, social phobia and agoraphobia, the 8-item BPIIDQ-8 was constructed. The BPIIDQ-8 differentiated subjects with BP-II from those with UP depression with a sensitivity/specificity of 0.75/0.63 for the whole sample and 0.77/0.72 for a female subgroup with a history of childbirth. The BPIIDQ-8 can differentiate BP-II from UP depression at the secondary care level with satisfactory to good reliability and validity. It has good potential as a screening tool for BP-II depression in primary care settings. Recall bias, the relatively small sample size, and the high proportion of females in the BP-II sample limit the generalization of the results. PMID:26963908

  5. Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report.

    PubMed

    Maahs, David M; Buckingham, Bruce A; Castle, Jessica R; Cinar, Ali; Damiano, Edward R; Dassau, Eyal; DeVries, J Hans; Doyle, Francis J; Griffen, Steven C; Haidar, Ahmad; Heinemann, Lutz; Hovorka, Roman; Jones, Timothy W; Kollman, Craig; Kovatchev, Boris; Levy, Brian L; Nimri, Revital; O'Neal, David N; Philip, Moshe; Renard, Eric; Russell, Steven J; Weinzimer, Stuart A; Zisser, Howard; Lum, John W

    2016-07-01

    Research on and commercial development of the artificial pancreas (AP) continue to progress rapidly, and the AP promises to become a part of clinical care. In this report, members of the JDRF Artificial Pancreas Project Consortium in collaboration with the wider AP community 1) advocate for the use of continuous glucose monitoring glucose metrics as outcome measures in AP trials, in addition to HbA1c, and 2) identify a short set of basic, easily interpreted outcome measures to be reported in AP studies whenever feasible. Consensus on a broader range of measures remains challenging; therefore, reporting of additional metrics is encouraged as appropriate for individual AP studies or study groups. Greater consistency in reporting of basic outcome measures may facilitate the interpretation of study results by investigators, regulatory bodies, health care providers, payers, and patients themselves, thereby accelerating the widespread adoption of AP technology to improve the lives of people with type 1 diabetes.

  6. Outcome Discrepancies and Selective Reporting: Impacting the Leading Journals?

    PubMed Central

    Fleming, Padhraig S.; Koletsi, Despina; Dwan, Kerry; Pandis, Nikolaos

    2015-01-01

    Background Selective outcome reporting of either interesting or positive research findings is problematic, running the risk of poorly-informed treatment decisions. We aimed to assess the extent of outcome and other discrepancies and possible selective reporting between registry entries and published reports among leading medical journals. Methods Randomized controlled trials published over a 6-month period from July to December 31st, 2013, were identified in five high impact medical journals: The Lancet, British Medical Journal, New England Journal of Medicine, Annals of Internal Medicine and Journal of American Medical Association were obtained. Discrepancies between published studies and registry entries were identified and related to factors including registration timing, source of funding and presence of statistically significant results. Results Over the 6-month period, 137 RCTs were found. Of these, 18% (n = 25) had discrepancies related to primary outcomes with the primary outcome changed in 15% (n = 20). Moreover, differences relating to non-primary outcomes were found in 64% (n = 87) with both omission of pre-specified non-primary outcomes (39%) and introduction of new non-primary outcomes (44%) common. No relationship between primary or non-primary outcome change and registration timing (prospective or retrospective; P = 0.11), source of funding (P = 0.92) and presence of statistically significant results (P = 0.92) was found. Conclusions Discrepancies between registry entries and published articles for primary and non-primary outcomes were common among trials published in leading medical journals. Novel approaches are required to address this problem. PMID:25996928

  7. Morning stiffness and other patient-reported outcomes of rheumatoid arthritis in clinical practice.

    PubMed

    Sokka, T

    2011-01-01

    Morning stiffness has been recognized in traditional approaches to assessment of disease activity in rheumatoid arthritis (RA). Although morning stiffness is not specific to RA, changes in morning stiffness for an individual patient are helpful when monitoring health status. Health professionals can ask about morning stiffness but the most accurate and consistent approach to assessment from one visit to the next appears to be a patient self-report questionnaire. However, quantitative measures of patient-reported data are not an integral part of clinical monitoring in most clinics. No single measure is adequate for all individual patients, so quantitative measurement of patient-reported data should include many elements such as pain, functional status, fatigue, sleep, morning stiffness, work capacity, and physical and emotional well-being. In daily clinical practice, patient-reported outcomes can be collected easily using a standard questionnaire that patients can complete with pencil and paper or electronically on a touch screen in the waiting room. The results are then immediately available to the rheumatologists, to facilitate doctor-patient communication to improve the quality of patient care, leading to better patient outcomes.

  8. Patient reported outcomes as endpoints in medical research.

    PubMed

    Fairclough, Diane L

    2004-04-01

    This review covers a number of the many design and analytic issues associated with clinical trials that incorporate patient reported outcomes as primary or secondary endpoints. We use a clinical trial designed to evaluate a new therapy for the prevention of migraines to illustrate how endpoints are defined by the objectives of the study, the methods for handling longitudinal assessments with multiple scales or outcomes, and the methods of analysis in the presence of missing data.

  9. The Adult Repetitive Behaviours Questionnaire-2 (RBQ-2A): A Self-Report Measure of Restricted and Repetitive Behaviours

    ERIC Educational Resources Information Center

    Barrett, Sarah L.; Uljarevic, Mirko; Baker, Emma K.; Richdale, Amanda L.; Jones, Catherine R. G.; Leekam, Susan R.

    2015-01-01

    In two studies we developed and tested a new self-report measure of restricted and repetitive behaviours (RRB) suitable for adults. In Study 1, The Repetitive Behaviours Questionnaire-2 for adults (RBQ-2A) was completed by a sample of 163 neurotypical adults. Principal components analysis revealed two components: Repetitive Motor Behaviours and…

  10. Brief Report: Preliminary Reliability, Construct Validity and Standardization of the Auditory Behavior Questionnaire (ABQ) for Children with Autism Spectrum Disorders

    ERIC Educational Resources Information Center

    Egelhoff, Kelsey; Lane, Alison E.

    2013-01-01

    The Auditory Behavior Questionnaire (ABQ) evaluates abnormal behavioral responses to auditory stimulation in children with Autism Spectrum Disorder (ASD). This study reports preliminary reliability, construct validity and standardization of the ABQ. Parents of children with ASD aged 7-21 years (n = 165) completed the ABQ on-line. Cronbach's alpha…

  11. [Performance of the Self-Reporting Questionnaire as a psychiatric screening questionnaire: a comparative study with Structured Clinical Interview for DSM-IV-TR].

    PubMed

    Gonçalves, Daniel Maffasioli; Stein, Airton Tetelbon; Kapczinski, Flavio

    2008-02-01

    The SRQ (Self-Reporting Questionnaire) is a psychiatric screening tool that originally included 30 questions. The Brazilian version of SRQ-20 (a version that includes the 20 items for non-psychotic mental disorders) was validated in the early 1980s. The objective of the present study was to validate the Brazilian version of SRQ-20 and the 5 items for alcohol-related disorders as compared to the SCID-IV-TR (Structured Clinical Interview for DSM-IV-TR) as the gold standard. The study was conducted in Santa Cruz do Sul, a small town in southern Brazil, with 485 subjects (54.8% females, mean age 40.04 years). The 5 items for alcohol-related disorders showed low sensitivity (66%). The optimum cutoff value for SRQ-20 was 7/8, with 86.33% sensitivity and 89.31% specificity. The discriminant power of SRQ-20 for psychiatric screening was 0.9, and Cronbach's alpha was 0.86.

  12. The design and validation of a parent-report questionnaire for assessing the characteristics and quality of early intervention over time.

    PubMed

    Young, Alys; Gascon-Ramos, Maria; Campbell, Malcolm; Bamford, John

    2009-01-01

    This article concerns a parent-report repeat questionnaire to evaluate the quality of multiprofessional early intervention following early identification of deafness. It discusses the rationale for the design of the instrument, its theoretical underpinnings, its psychometric properties, and its usability. Results for the validity and reliability of the instrument are based on completion by 82 parents. The questionnaire is divided into four sections. "The description of the structure of professional services" demonstrated good face and content validity; the "content of intervention scale" yielded high internal consistency (Cronbach's alpha = 0.88) and reliability (6-month test-retest correlations, rho = 0.88, r = .68; 12-month test-retest correlations, rho = 0.60, r = .82); the "process of intervention" scale yielded high internal consistency (Cronbach's alpha = 0.93) and high reliability on test-retest administration (6-month test-retest correlations, r = 0.64; 12 month test-retest correlations, r = .82); and the short "overall impact" questions were answered well. The Trait Emotional Intelligence Questionnaire was used to control for influence of parental disposition on ratings of quality of intervention. Evaluating the goodness of fit between early intervention and parental priorities/values is discussed as a vital component in improving child and family outcomes.

  13. The Design and Validation of a Parent-Report Questionnaire for Assessing the Characteristics and Quality of Early Intervention Over Time

    PubMed Central

    Gascon-Ramos, Maria; Campbell, Malcolm; Bamford, John

    2009-01-01

    This article concerns a parent-report repeat questionnaire to evaluate the quality of multiprofessional early intervention following early identification of deafness. It discusses the rationale for the design of the instrument, its theoretical underpinnings, its psychometric properties, and its usability. Results for the validity and reliability of the instrument are based on completion by 82 parents. The questionnaire is divided into four sections. “The description of the structure of professional services” demonstrated good face and content validity; the “content of intervention scale” yielded high internal consistency (Cronbach's α = 0.88) and reliability (6-month test–retest correlations, rho = 0.88, r = .68; 12-month test–retest correlations, rho = 0.60, r = .82); the “process of intervention” scale yielded high internal consistency (Cronbach's α = 0.93) and high reliability on test–retest administration (6-month test–retest correlations, r = 0.64; 12 month test–retest correlations, r = .82); and the short “overall impact” questions were answered well. The Trait Emotional Intelligence Questionnaire was used to control for influence of parental disposition on ratings of quality of intervention. Evaluating the goodness of fit between early intervention and parental priorities/values is discussed as a vital component in improving child and family outcomes. PMID:19617378

  14. Application of Bother in patient reported outcomes instruments across cultures

    PubMed Central

    2014-01-01

    Background The objective of this study was to determine the applicability of the term bother, as used in Patient Reported Outcomes (PRO) instruments that will be translated into foreign languages from English for the United States. Bother is versatile in English for the U.S., in that it can describe negative mental states and physical sensations, as well as social disturbances. Bother has many different meanings across cultures, due to this versatility. Alternatives for bother were explored for future PRO instrument development. Methods A PRO instrument used to evaluate the degree of bother resulting from psoriasis was analyzed. This disease can negatively impact patients physically, emotionally and socially. Translations of bother were analyzed to determine its meaning when translated into other languages. Cognitive debriefing was conducted on psoriasis patients with the instrument containing bother. Following cognitive debriefing, a questionnaire was distributed to linguists and cognitive debriefing subjects to collect definitions of bother in each target language, and detail any difficulty with translation. To establish alternatives to bother and demonstrate the breakdown of concepts within bother, translations of the Dermatology Quality of Life Index (DLQI) were analyzed. This instrument was selected for its focus on psoriasis and use of terminology that lacks the ambiguity of bother. Results An analysis of back-translations revealed that bother yielded a back-translation that was conceptually different from the source 20% of the time (5/26). Analysis of alternative terminology found in the DLQI revealed much greater conceptual equivalence when translated into other languages. Conclusion When developing the wording of PRO instruments, the terminology chosen should be applicable across languages to allow for international pooling and comparison of data. While all linguists and subjects of cognitive debriefing understood bother to have a negative connotation, a

  15. Temporal preference in individuals reporting chronic pain: discounting of delayed pain-related and monetary outcomes.

    PubMed

    Tompkins, D Andrew; Johnson, Patrick S; Smith, Michael T; Strain, Eric C; Edwards, Robert R; Johnson, Matthew W

    2016-08-01

    Opioid therapy for pain is associated with an increased risk for substance use disorders. This study's purpose was to determine the association between opioid misuse propensity (Screener and Opioid Assessment for Patients in Pain-Revised) and delay discounting (DD), a behavioral process linked to substance use disorders, which quantifies the extent to which outcomes are devalued because of their delay. Participants reporting chronic pain (N = 249) answered pain and opioid use questions and then completed 4 DD tasks. Each of these tasks assessed either money or pain consequences, framed as either rewards or punishments. Each task involved hypothetical choices between immediate smaller vs delayed larger consequences. The extant Monetary Choice Questionnaire assessed DD of money rewards, and a modified version assessed discounting of money losses (immediate smaller loss vs larger delayed loss). Based on the Monetary Choice Questionnaire, the novel Pain Relief Choice Questionnaire assessed choices between an immediate short duration of pain relief vs a longer duration of pain relief. Similarly, the novel Additional Pain Choice Questionnaire assessed choices between an immediate short duration of additional pain vs a longer duration of additional pain. Discounting of both additional pain and money losses were significantly associated with high Screener and Opioid Assessment for Patients in Pain-Revised scores-indicating participants at greatest risk for opioid misuse discount future punishments rather than future rewards compared with those at low risk. Measures of DD may have promise in more accurately identifying individuals at highest risk for opioid misuse during chronic opioid therapy.

  16. Longitudinal Surveys of Australian Youth (LSAY) 2009 Cohort: Wave 2 (2010)-- Questionnaire. Technical Report 71A

    ERIC Educational Resources Information Center

    National Centre for Vocational Education Research (NCVER), 2012

    2012-01-01

    The Longitudinal Surveys of Australian Youth (LSAY) program studies the progress of several groups of young Australians as they move from school into post-secondary education and work. This technical paper contains the questionnaire for the LSAY 2009 cohort Wave 2 (2010) data set.

  17. Current Issues in the Teaching of English: Report on a Questionnaire Study; English Curricula in Australia.

    ERIC Educational Resources Information Center

    Australian Council for Educational Research, Hawthorn.

    The first two papers in this volume discusses the results of questionnaires intended for primary and secondary teachers to elicit information on current issues in the teaching of English in Australia. It was learned that secondary teachers reached consensus only on the very broadest levels. They all agreed that literature, communication, and…

  18. Longitudinal Surveys of Australian Youth (LSAY): 2006 Cohort Wave 4 (2009)--Questionnaire. Technical Report 56A

    ERIC Educational Resources Information Center

    National Centre for Vocational Education Research (NCVER), 2010

    2010-01-01

    The Longitudinal Surveys of Australian Youth (LSAY) program studies the progress of several groups of young Australians as they move from school into post-secondary education and work. This technical paper contains the questionnaire for the LSAY 2006 cohort Wave 4 (2009) data set. [For the "Longitudinal Surveys of Australian Youth (LSAY):…

  19. Longitudinal Surveys of Australian Youth (LSAY) 2006 Cohort: Wave 6 (2011)--Questionnaire. Technical Report 75A

    ERIC Educational Resources Information Center

    National Centre for Vocational Education Research (NCVER), 2012

    2012-01-01

    The Longitudinal Surveys of Australian Youth (LSAY) program studies the progress of several groups of young Australians as they move from school into post-secondary education and work. This series of documents provides supporting information for the LSAY data set of the 2006 cohort at wave 6 (2011). The document presents the questionnaire for LSAY…

  20. Longitudinal Surveys of Australian Youth (LSAY) 1998 Cohort: Wave 12 (2009)--Questionnaire. Technical Report 58A

    ERIC Educational Resources Information Center

    National Centre for Vocational Education Research (NCVER), 2010

    2010-01-01

    The Longitudinal Surveys of Australian Youth (LSAY) program studies the progress of several groups of young Australians as they move from school into post-secondary education and work. This technical paper contains the questionnaire for the LSAY 1998 cohort Wave 12 (2009) data set. [For the accompanying frequency tables, "Longitudinal Surveys…

  1. Initial Psychometric Properties of the Experiences Questionnaire: Validation of a Self-Report Measure of Decentering

    ERIC Educational Resources Information Center

    Fresco, David M.; Moore, Michael T.; van Dulmen, Manfred H. M.; Segal, Zindel V.; Ma, S. Helen; Teasdale, John D.; Williams, J. Mark G.

    2007-01-01

    Decentering is defined as the ability to observe one's thoughts and feelings as temporary, objective events in the mind, as opposed to reflections of the self that are necessarily true. The Experiences Questionnaire (EQ) was designed to measure both decentering and rumination but has not been empirically validated. The current study investigated…

  2. The Development of a Questionnaire to Measure Students' Motivation Towards Science Learning. Research Report

    ERIC Educational Resources Information Center

    Tuan, Hsiao-Lin; Chin, Chi-Chin; Shieh, Shyang-Horng

    2005-01-01

    The purpose of this study was to develop a questionnaire that measures students' motivation toward science learning (SMTSL). Six scales were developed: self-efficacy, active learning strategies, science learning value, performance goal, achievement goal, and learning environment stimulation. In total, 1407 junior high school students from central…

  3. Enterobacter cloacae Postsurgical Endophthalmitis: Report of a Positive Outcome

    PubMed Central

    Butikofer, Scott; Dettori, Jason M.; Vemulakonda, G. Atma; Slabaugh, Mark

    2013-01-01

    We report a positive outcome of postcataract endophthalmitis caused by Enterobacter cloacae, which has previously resulted in poor outcomes in endophthalmitis. A 67-year-old man underwent uncomplicated cataract surgery. On the morning of postoperative day (POD) #1, he had significant anterior chamber inflammation without pain, hypopyon, or vitritis but then rapidly developed hypopyon and worsening visual acuity. He underwent a tap and inject with vancomycin and ceftazidime and was prescribed topical steroids and antibiotics as well as oral levofloxacin. On POD #3, cultures of the vitreous and aqueous returned positive for E. cloacae. By POD #6, his hypopyon had resolved with improved vitritis, decreased inflammation, and visual acuity of 20/200. Two weeks after surgery, his best-corrected visual acuity was 20/60. Contrary to prior reports, we demonstrate that it is possible to achieve a good outcome in cases of E. cloacae endophthalmitis treated early with appropriate antibiotics and anti-inflammatory agents. PMID:23626573

  4. [The benefits of using patient-reported outcomes in cancer treatment: an overview].

    PubMed

    Wintner, Lisa M; Giesinger, Johannes M; Kemmler, Georg; Sztankay, Monika; Oberguggenberger, Anne; Gamper, Eva-Maria; Sperner-Unterweger, Barbara; Holzner, Bernhard

    2012-05-01

    The patient's perspective evaluated by patient-reported outcomes (PROs) gains more and more importance, since treatment efficacy is no longer solely linked to clinical outcomes like cure and overall survival. Ailments like pain, fatigue and social isolation can only be assessed by patients' direct expression without any interpretation made by medical staff. PROs facilitate the disclosure of quality of life issues and patients feel a stronger support due to improved communication. PROs offer many further advantages like saving of time, cost and staff, targeted intervention and sensitizing of clinicians. Also, internationally validated questionnaires are available and the development of electronic PROs eases data-collection, calculation and storage. PROs collected within clinical routine are versatile concerning their applicability: They can be used for scientific analyses, quality assurance, and health technology assessment.

  5. Reporting accuracy of population dietary sodium intake using duplicate 24 h dietary recalls and a salt questionnaire.

    PubMed

    De Keyzer, Willem; Dofková, Marcela; Lillegaard, Inger Therese L; De Maeyer, Mieke; Andersen, Lene Frost; Ruprich, Jirí; Řehůřková, Irena; Geelen, Anouk; van 't Veer, Pieter; De Henauw, Stefaan; Crispim, Sandra Patricia; de Boer, Evelien; Ocké, Marga; Slimani, Nadia; Huybrechts, Inge

    2015-02-14

    High dietary Na intake is associated with multiple health risks, making accurate assessment of population dietary Na intake critical. In the present study, reporting accuracy of dietary Na intake was evaluated by 24 h urinary Na excretion using the EPIC-Soft 24 h dietary recall (24-HDR). Participants from a subsample of the European Food Consumption Validation study (n 365; countries: Belgium, Norway and Czech Republic), aged 45-65 years, completed two 24 h urine collections and two 24-HDR. Reporting accuracy was calculated as the ratio of reported Na intake to that estimated from the urinary biomarker. A questionnaire on salt use was completed in order to assess the discretionary use of table and cooking salt. The reporting accuracy of dietary Na intake was assessed using two scenarios: (1) a salt adjustment procedure using data from the salt questionnaire; (2) without salt adjustment. Overall, reporting accuracy improved when data from the salt questionnaire were included. The mean reporting accuracy was 0·67 (95 % CI 0·62, 0·72), 0·73 (95 % CI 0·68, 0·79) and 0·79 (95 % CI 0·74, 0·85) for Belgium, Norway and Czech Republic, respectively. Reporting accuracy decreased with increasing BMI among male subjects in all the three countries. For women from Belgium and Norway, reporting accuracy was highest among those classified as obese (BMI ≥ 30 kg/m2: 0·73, 95 % CI 0·67, 0·81 and 0·81, 95 % CI 0·77, 0·86, respectively). The findings from the present study showed considerable underestimation of dietary Na intake assessed using two 24-HDR. The questionnaire-based salt adjustment procedure improved reporting accuracy by 7-13 %. Further development of both the questionnaire and EPIC-Soft databases (e.g. inclusion of a facet to describe salt content) is necessary to estimate population dietary Na intakes accurately.

  6. Psychometric properties of an innovative self-report measure: The Social Anxiety Questionnaire for Adults

    PubMed Central

    Caballo, Vicente E.; Arias, Benito; Salazar, Isabel C.; Irurtia, María Jesús; Hofmann, Stefan G.

    2015-01-01

    This paper presents the psychometric properties of a new measure of social anxiety, the Social Anxiety Questionnaire for adults (SAQ), composed of 30 items that were developed based on participants from 16 Latin American countries, Spain, and Portugal. Two groups of participants were included in the study: a non-clinical group involving 18,133 persons and a clinical group comprising 334 patients with a diagnosis of social anxiety disorder (social phobia). Exploratory and confirmatory factor analyses supported a 5-factor structure of the questionnaire. The factors were labeled: 1) Interactions with strangers, 2) Speaking in public/talking with people in authority, 3) Interactions with the opposite sex, 4) Criticism and embarrassment, and 5) Assertive expression of annoyance, disgust or displeasure. Psychometric evidence supported the internal consistency, convergent validity, and measurement invariance of the SAQ. To facilitate clinical applications, a ROC analysis identified cut scores for men and women for each factor and for the global score. PMID:25774643

  7. Psychometric properties of an innovative self-report measure: The Social Anxiety Questionnaire for adults.

    PubMed

    Caballo, Vicente E; Arias, Benito; Salazar, Isabel C; Irurtia, María Jesús; Hofmann, Stefan G

    2015-09-01

    This article presents the psychometric properties of a new measure of social anxiety, the Social Anxiety Questionnaire for adults (SAQ), composed of 30 items that were developed based on participants from 16 Latin American countries, Spain, and Portugal. Two groups of participants were included in the study: a nonclinical group involving 18,133 persons and a clinical group comprising 334 patients with a diagnosis of social anxiety disorder (social phobia). Exploratory and confirmatory factor analyses supported a 5-factor structure of the questionnaire. The factors were labeled as follows: (1) Interactions with strangers, (2) Speaking in public/talking with people in authority, (3) Interactions with the opposite sex, (4) Criticism and embarrassment, and (5) Assertive expression of annoyance, disgust, or displeasure. Psychometric evidence supported the internal consistency, convergent validity, and measurement invariance of the SAQ. To facilitate clinical applications, a receiver operating characteristics (ROC) analysis identified cut scores for men and women for each factor and for the global score.

  8. Patient-reported outcomes in obsessive-compulsive disorder.

    PubMed

    Subramaniam, Mythily; Soh, Pauline; Ong, Clarissa; Esmond Seow, Lee Seng; Picco, Louisa; Vaingankar, Janhavi Ajit; Chong, Siow Ann

    2014-06-01

    The purpose of the article was to provide an overview of patient-reported outcomes (PROs) and related measures that have been examined in the context of obsessive-compulsive disorder (OCD). The current review focused on patient-reported outcome measures (PROMs) that evaluated three broad outcome domains: functioning, health-related quality of life (HRQoL), and OCD-related symptoms. The present review ultimately included a total of 155 unique articles and 22 PROMs. An examination of the PROs revealed that OCD patients tend to suffer from significant functional disability, and report lower HRQoL than controls. OCD patients report greater symptom severity than patients with other mental disorders and evidence indicates that PROMs are sensitive to change and may be even better than clinician-rated measures at predicting treatment outcomes. Nonetheless, it should be noted that the measures reviewed lacked patient input in their development. Future research on PROMs must involve patient perspectives and include rigorous psychometric evaluation of these measures.

  9. Meeting Report: Outcomes from the Undergraduate Research Summit

    ERIC Educational Resources Information Center

    Wenzel, Thomas J.

    2004-01-01

    This article reports the outcomes from the undergraduate research summit held on August 2003 at Bates College in Lewiston, Maine. This summit brought together an array of stakeholders from the chemistry community, ranging from those with a long history of success in undergraduate research to junior faculty members who have started on a trajectory…

  10. Patient-reported outcomes in obsessive-compulsive disorder

    PubMed Central

    Subramaniam, Mythily; Soh, Pauline; Ong, Clarissa; Esmond Seow, Lee Seng; Picco, Louisa; Vaingankar, Janhavi Ajit; Chong, Siow Ann

    2014-01-01

    The purpose of the article was to provide an overview of patient-reported outcomes (PROs) and related measures that have been examined in the context of obsessive-compulsive disorder (OCD). The current review focused on patient-reported outcome measures (PROMs) that evaluated three broad outcome domains: functioning, health-related quality of life (HRQoL), and OCD-related symptoms. The present review ultimately included a total of 155 unique articles and 22 PROMs. An examination of the PROs revealed that OCD patients tend to suffer from significant functional disability, and report lower HRQoL than controls. OCD patients report greater symptom severity than patients with other mental disorders and evidence indicates that PROMs are sensitive to change and may be even better than clinician-rated measures at predicting treatment outcomes. Nonetheless, it should be noted that the measures reviewed lacked patient input in their development. Future research on PROMs must involve patient perspectives and include rigorous psychometric evaluation of these measures. PMID:25152661

  11. Assessing Adult Leisure Activities: An Extension of a Self-Report Activity Questionnaire

    PubMed Central

    Jopp, Daniela; Hertzog, Christopher

    2009-01-01

    Everyday leisure activities in adulthood and old age have been investigated with respect to constructs such as successful aging, an engaged lifestyle, and prevention of age-related cognitive decline. They also relate to mental health and have clinical value as they can inform diagnosis and interventions. In the present study, we enhanced the content validity of the Victoria Longitudinal Study activity questionnaire by adding items on physical and social activities, and validated a shortened version of the questionnaire. Our proposed leisure activity model included 11 activity categories: three types of social activities (i.e., activities with close social partners, group-centered public activity, religious activities), physical, developmental, and experiential activities, crafts, game playing, TV watching, travel, and technology use. Confirmatory factor analyses validated the proposed factor structure in two independent samples. A higher-order model with a general activity factor fitted the activity factor correlations with relatively little loss of fit. Convergent and discriminant validity for the activity scales were supported by patterns of their correlations with education, health, depression, cognition, and personality. In sum, the scores derived from of the augmented VLS activity questionnaire demonstrate good reliability, and validity evidence supports their use as measure of leisure activities in young, middle-aged, and older individuals. PMID:20230157

  12. Assessing adult leisure activities: an extension of a self-report activity questionnaire.

    PubMed

    Jopp, Daniela S; Hertzog, Christopher

    2010-03-01

    Everyday leisure activities in adulthood and old age have been investigated with respect to constructs such as successful aging, an engaged lifestyle, and prevention of age-related cognitive decline. They also relate to mental health and have clinical value, as they can inform diagnosis and interventions. In the present study, the authors enhanced the content validity of the Victoria Longitudinal Study activity questionnaire by adding items on physical and social activities and validated a shortened version of the questionnaire. The proposed leisure activity model included 11 activity categories: 3 types of social activities (i.e., activities with close social partners, group-centered public activity, religious activities), physical activities, developmental activities, experiential activities, crafts, game playing, TV watching, travel, and technology use. Confirmatory factor analyses validated the proposed factor structure in 2 independent samples. A higher order model with a general activity factor fitted the activity factor correlations with relatively little loss of fit. Convergent and discriminant validity for the activity scales were supported by patterns of their correlations with education, health, depression, cognition, and personality. In sum, the scores derived from of the augmented Victoria Longitudinal Study activity questionnaire demonstrate good reliability, and validity evidence supports their use as measures of leisure activities in young, middle-aged, and older individuals.

  13. The Adult Repetitive Behaviours Questionnaire-2 (RBQ-2A): A Self-Report Measure of Restricted and Repetitive Behaviours.

    PubMed

    Barrett, Sarah L; Uljarević, Mirko; Baker, Emma K; Richdale, Amanda L; Jones, Catherine R G; Leekam, Susan R

    2015-11-01

    In two studies we developed and tested a new self-report measure of restricted and repetitive behaviours (RRB) suitable for adults. In Study 1, The Repetitive Behaviours Questionnaire-2 for adults (RBQ-2A) was completed by a sample of 163 neurotypical adults. Principal components analysis revealed two components: Repetitive Motor Behaviours and Insistence on Sameness. In Study 2, the mean RBQ-2A scores of a group of adults with autism spectrum disorder (ASD; N = 29) were compared to an adult neurotypical group (N = 37). The ASD sample had significantly higher total and subscale scores. These results indicate that the RBQ-2A has utility as a self-report questionnaire measure of RRBs suitable for adults, with potential clinical application.

  14. Memory worries and self-reported daily forgetfulness: a psychometric evaluation of the Dutch translation of the Multifactorial Memory Questionnaire.

    PubMed

    van der Werf, Sieberen P; Vos, Sandra H

    2011-02-01

    The expression of memory worries and the self-reporting of daily forgetfulness easily spark discussion among sufferers and their family or friends about what is normal or abnormal forgetfulness. One way to investigate whether the reporting of forgetfulness might be excessive is to use a standardized memory questionnaire--for instance, the Multifactorial Memory Questionnaire (MMQ). The MMQ measures worries, daily forgetfulness, and memory strategy use. In this study we present a psychometric evaluation of the Dutch translation of the MMQ and provide normative data to determine the significance of individual differences in subtest scores. In addition, clinical examples are given of the use and interpretation of percentile norms and single-case statistics.

  15. How patient outcomes are reported in drug advertisements.

    PubMed Central

    Lexchin, J.

    1999-01-01

    OBJECTIVE: To examine how changes in outcomes are reported in drug advertisements in medical journals. QUALITY OF EVIDENCE: Advertisements from a convenience sample of 38 issues of Canadian Family Physician, Canadian Journal of Anaesthesia, Canadian Journal of Psychiatry, Canadian Medical Association Journal, and the New England Journal of Medicine. MAIN MESSAGE: Method of reporting changes in clinical outcomes (relative risk reduction [RRR], absolute risk reduction [ARR], number needed to treat [NNT]), name of product, and company marketing product were sought. In the 22 advertisements included in the analysis, 11 reported results as RRRs; two reported results as RRRs, but readers could calculate ARRs or NNTs from figures given in the advertisement; and nine gave no measure of results, but readers could calculate RRRs, ARRs, or NNTs from figures given. CONCLUSIONS: Most companies report changes in outcomes as RRRs, and this bias could influence the way physicians prescribe. Changes to the rules governing journal advertising and increased emphasis on critical appraisal skills would help mitigate this bias. PMID:10349065

  16. The effect of implementing the Outcome Questionnaire-45.2 feedback system in Norway: A multisite randomized clinical trial in a naturalistic setting.

    PubMed

    Amble, Ingunn; Gude, Tore; Stubdal, Sven; Andersen, Bror Just; Wampold, Bruce E

    2015-01-01

    It has been claimed that the monitoring of ongoing psychotherapy is of crucial importance for improving the quality of mental health care. This study investigated the effect of using the Norwegian version of the patient feedback system OQ-Analyst using the Outcome Questionnaire-45.2. Patients from six psychiatric clinics in Southern Norway (N = 259) were randomized to feedback (FB) or no feedback (NFB). The main effect of feedback was statistical significant (p = .027), corroborating the hypothesis that feedback would improve the quality of services, although the size of the effect was small to moderate (d = 0.32). The benefits of feedback have to be considered against the costs of implementation.

  17. Test-retest reliability and predictors of unreliable reporting for a sexual behavior questionnaire for U.S. men.

    PubMed

    Nyitray, Alan G; Harris, Robin B; Abalos, Andrew T; Nielson, Carrie M; Papenfuss, Mary; Giuliano, Anna R

    2010-12-01

    Accurate knowledge about human sexual behaviors is important for increasing our understanding of human sexuality; however, there have been few studies assessing the reliability of sexual behavior questionnaires designed for community samples of adult men. A test-retest reliability study was conducted on a questionnaire completed by 334 men who had been recruited in Tucson, Arizona. Reliability coefficients and refusal rates were calculated for 39 non-sexual and sexual behavior questionnaire items. Predictors of unreliable reporting for lifetime number of female sexual partners were also assessed. Refusal rates were generally low, with slightly higher refusal rates for questions related to immigration, income, the frequency of sexual intercourse with women, lifetime number of female sexual partners, and the lifetime number of male anal sex partners. Kappa and intraclass correlation coefficients were substantial or almost perfect for all non-sexual and sexual behavior items. Reliability dropped somewhat, but was still substantial, for items that asked about household income and the men's knowledge of their sexual partners' health, including abnormal Pap tests and prior sexually transmitted diseases (STD). Age and lifetime number of female sexual partners were independent predictors of unreliable reporting while years of education was inversely associated with unreliable reporting. These findings among a community sample of adult men are consistent with other test-retest reliability studies with populations of women and adolescents.

  18. The Discrete Emotions Questionnaire: A New Tool for Measuring State Self-Reported Emotions

    PubMed Central

    Harmon-Jones, Cindy; Bastian, Brock

    2016-01-01

    Several discrete emotions have broad theoretical and empirical importance, as shown by converging evidence from diverse areas of psychology, including facial displays, developmental behaviors, and neuroscience. However, the measurement of these states has not progressed along with theory, such that when researchers measure subjectively experienced emotions, they commonly rely on scales assessing broad dimensions of affect (positivity and negativity), rather than discrete emotions. The current manuscript presents four studies that validate a new instrument, the Discrete Emotions Questionnaire (DEQ), that is sensitive to eight distinct state emotions: anger, disgust, fear, anxiety, sadness, happiness, relaxation, and desire. Emotion theory supporting the importance of distinguishing these specific emotions is reviewed. PMID:27500829

  19. Clients' Perception of Outcome of Team-Based Prenatal and Reproductive Genetic Counseling in Serbian Service Using the Perceived Personal Control (PPC) Questionnaire.

    PubMed

    Cuturilo, Goran; Vucinic, Olivera Kontic; Novakovic, Ivana; Ignjatovic, Svetlana; Mijovic, Marija; Sulovic, Nenad; Vukolic, Dusan; Komnenic, Milica; Tadic, Jasmina; Cetkovic, Aleksandar; Belic, Aleksandra; Ljubic, Aleksandar

    2016-02-01

    This is the first study in Serbia and the region of South-East Europe dedicated to clients' perception of outcome and efficiency of prenatal and reproductive genetic counseling. The primary aim of this study was to assess overall value and success of genetic counseling in prenatal and reproductive care with regard to perceived personal control of clients, reflecting also in a part patient comprehension, knowledge retention, and empowerment in decision-making. The standardized Perceived Personal Control questionnaire (PPC) was used for the assessment of 239 female participants. First, we performed a complete validation of the psychometric characteristics of the Serbian-language version of the PPC questionnaire. The validation of the questionnaire permits other researchers from Serbian-speaking regions of South-East Europe to use this standard instrument to assess the effectiveness of prenatal genetic counseling in their communities and analyze advantages and disadvantages of their counseling models. We also measured social and demographic characteristics of participants. Further, we analyzed effects of our team-based prenatal and reproductive genetic counseling model through (a) calculation of PPC scores at three different stages (before initial, after initial, and before second counseling session), and (b) by assessing participants' responses by indication for referral (advanced maternal age, abnormal biochemical screening, family history of hereditary disorders, maternal exposure to drugs, exposure to radiation, exposure to infective agents, infertility or recurrent abortions, and miscellaneous). The results indicate that participants' knowledge after initial counseling increased significantly and after that remained stable and sustainable. A satisfactory level of confidence among participants had been achieved, in that many felt an increased sense of control over their situation and emotional response to it. Indirectly, these results indicate the success of a

  20. Assessment of Learning Strategies: Self-Report Questionnaire or Learning Task

    ERIC Educational Resources Information Center

    Kikas, Eve; Jõgi, Anna-Liisa

    2016-01-01

    Two types of assessment instruments were developed to assess middle school students' learning strategies, and their effectiveness in predicting various learning outcomes was examined. The participants were 565 middle school students. Three subscales (rehearsal, organization, elaboration) from the "Motivated Strategies for Learning…

  1. Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer.

    PubMed

    Donovan, Jenny L; Hamdy, Freddie C; Lane, J Athene; Mason, Malcolm; Metcalfe, Chris; Walsh, Eleanor; Blazeby, Jane M; Peters, Tim J; Holding, Peter; Bonnington, Susan; Lennon, Teresa; Bradshaw, Lynne; Cooper, Deborah; Herbert, Phillipa; Howson, Joanne; Jones, Amanda; Lyons, Norma; Salter, Elizabeth; Thompson, Pauline; Tidball, Sarah; Blaikie, Jan; Gray, Catherine; Bollina, Prasad; Catto, James; Doble, Andrew; Doherty, Alan; Gillatt, David; Kockelbergh, Roger; Kynaston, Howard; Paul, Alan; Powell, Philip; Prescott, Stephen; Rosario, Derek J; Rowe, Edward; Davis, Michael; Turner, Emma L; Martin, Richard M; Neal, David E

    2016-10-13

    Background Robust data on patient-reported outcome measures comparing treatments for clinically localized prostate cancer are lacking. We investigated the effects of active monitoring, radical prostatectomy, and radical radiotherapy with hormones on patient-reported outcomes. Methods We compared patient-reported outcomes among 1643 men in the Prostate Testing for Cancer and Treatment (ProtecT) trial who completed questionnaires before diagnosis, at 6 and 12 months after randomization, and annually thereafter. Patients completed validated measures that assessed urinary, bowel, and sexual function and specific effects on quality of life, anxiety and depression, and general health. Cancer-related quality of life was assessed at 5 years. Complete 6-year data were analyzed according to the intention-to-treat principle. Results The rate of questionnaire completion during follow-up was higher than 85% for most measures. Of the three treatments, prostatectomy had the greatest negative effect on sexual function and urinary continence, and although there was some recovery, these outcomes remained worse in the prostatectomy group than in the other groups throughout the trial. The negative effect of radiotherapy on sexual function was greatest at 6 months, but sexual function then recovered somewhat and was stable thereafter; radiotherapy had little effect on urinary continence. Sexual and urinary function declined gradually in the active-monitoring group. Bowel function was worse in the radiotherapy group at 6 months than in the other groups but then recovered somewhat, except for the increasing frequency of bloody stools; bowel function was unchanged in the other groups. Urinary voiding and nocturia were worse in the radiotherapy group at 6 months but then mostly recovered and were similar to the other groups after 12 months. Effects on quality of life mirrored the reported changes in function. No significant differences were observed among the groups in measures of anxiety

  2. Tracking patient-reported outcomes in spinal disorders

    PubMed Central

    Nayak, Nikhil R.; Coats, John Mitchell; Abdullah, Kalil G.; Stein, Sherman C.; Malhotra, Neil R.

    2015-01-01

    Background: Patient-reported outcome measures (PROMs) quantify health status from the patient's point of view. While the number of published outcomes studies grows each year, so too has the number of instruments being reported, leading to confusion on which instruments are appropriate to use for various spinal conditions. Methods: A broad search was conducted to identify commonly used PROMs in patients undergoing spinal surgery. We searched PubMed for combinations of terms related to anatomic location and a measure of patient-reported outcome in the title or text. We supplemented the search using the “related articles” feature of PubMed and by manually searching the bibliographies of selected articles. Results: Major categories of PROMs in spine surgery include health-related quality-of-life, pain, and disease-specific disability, for which several different instrument options were identified and detailed. The minimal clinically important difference varies between instruments and differentiates statistical significance from clinical significance. In addition, the accurate estimation of costs has become a challenging but intrinsically linked variable to outcomes as increased attention is paid to the relative value of surgical interventions. Conclusion: While a number of PROMs are available for tracking outcomes in spine surgery, only a handful appear to be widely used. At least one instrument from each category should be measured pre- and post-operatively to quantify treatment effect. In addition, while the primary goal is to select the most appropriate instruments for the patient's condition, one should keep in mind sustainability of efforts with regard to patient and administrative burden. PMID:26605111

  3. Initial psychometric properties of the experiences questionnaire: validation of a self-report measure of decentering.

    PubMed

    Fresco, David M; Moore, Michael T; van Dulmen, Manfred H M; Segal, Zindel V; Ma, S Helen; Teasdale, John D; Williams, J Mark G

    2007-09-01

    Decentering is defined as the ability to observe one's thoughts and feelings as temporary, objective events in the mind, as opposed to reflections of the self that are necessarily true. The Experiences Questionnaire (EQ) was designed to measure both decentering and rumination but has not been empirically validated. The current study investigated the factor structure of the EQ in both undergraduate and clinical populations. A single, unifactorial decentering construct emerged using 2 undergraduate samples. The convergent and discriminant validity of this decentering factor was demonstrated in negative relationships with measures of depression symptoms, depressive rumination, experiential avoidance, and emotion regulation. Finally, the factor structure of the EQ was replicated in a clinical sample of individuals in remission from depression, and the decentering factor evidenced a negative relationship to concurrent levels of depression symptoms. Findings from this series of studies offer initial support for the EQ as a measure of decentering.

  4. Parenting Behavior in Mothers of Preschool Children with ASD: Development of a Self-Report Questionnaire

    PubMed Central

    Lambrechts, Greet; Maljaars, Jarymke; Boonen, Hannah; van Esch, Lotte; Van Leeuwen, Karla; Noens, Ilse

    2015-01-01

    Parents of young children with autism spectrum disorder (ASD) encounter many daily challenges and often experience much stress. However, little research exists about parenting behavior among these parents. With this study, we aim to address this gap. We examined the structure and internal consistency of a questionnaire intended to measure parenting behavior among mothers of young children with ASD. Furthermore, we compared parenting behavior among mothers of young children with and without ASD between two and six years old. Factor analyses resulted in a factor solution with seven subscales of parenting behavior. Two additional subscales especially relevant for parenting preschoolers with ASD were also considered. Analyses of covariance, controlling for gender and age, showed significantly higher scores for Discipline and Stimulating the Development in the control group in comparison with the ASD group. These findings suggest that mothers of preschoolers with ASD are still trying to find strategies to guide and stimulate their child's behavior and development effectively. PMID:26605085

  5. The relationship between interviewer–respondent race match and reporting of energy intake using food frequency questionnaires in the rural South United States

    PubMed Central

    Lemacks, Jennifer L.; Huye, Holly; Rupp, Renee; Connell, Carol

    2015-01-01

    Objective The purpose of the observational study was to determine whether interviewer race influences food frequency questionnaire (FFQ) reporting accuracy in a Deep South, largely African American cohort. Methods A secondary analysis was conducted to investigate the influence of interviewer race on energy reporting of 319 African Americans who participated in the Mississippi Communities for Healthy Living intervention in May–June 2011, a community-based and USDA-funded project. Reported energy intake was compared to total energy expenditure to identify normal (ENR), under-(EUR) and over-reporters (EOR). Multivariate logistic regression models determined the relationship between race match and energy misreporting, accounting for confounding variables (educational level, health status perception, BMI, gender, and age) identified using chi-square/correlation analyses. Results The sample included 278 African Americans with 165 EURs, 26 EORs, and 87 ENRs identified. Logistic regression analyses revealed that there was no relationship between race-matched participants and EUR or EOR; controlling factors, BMI and perceived health status were significant in the model. Conclusion This study is the first to our knowledge to examine whether race influences dietary intake reporting which may influence assessment data used for comparison with health outcomes. This may have important implications for research conducted in health disparate populations, particularly rural, Southern populations. PMID:26844114

  6. Patient reported outcomes in the assessment of premature ejaculation

    PubMed Central

    2016-01-01

    The term ‘Patient Reported Outcome’, abbreviated as PRO, was introduced by the US Food and Drug Administration (FDA) which proposed guidance on the development and validation of PROs. Previously PROs were known as self-report diaries, event-logs, self-administered questionnaires, and clinician administered rating scales. PROs seek to capture the subjective perceptions of patients and/or partner’s related to their specific symptoms, degree of bother, efficacy of a medication or psychotherapy intervention, and quality of life issues related to a specific condition. This article reviews the essential psychometric and regulatory agency requirements in the development of PROs. The constructs of reliability, various forms of validity, sensitivity, and specificity as well as concerns with translating a PRO into a different language are reviewed. Three PROs, the Premature Ejaculation Profile (PEP), the Index of Premature Ejaculation (IPE) and the Premature Ejaculation Diagnostic Tool (PEDT) all used in the assessment of premature ejaculation (PE) are discussed. These questionnaires meet or exceed all the psychometric requirements and have been employed in clinical trials and observational studies of men with PE. The article concludes on discussing some of the limitations of PRO use and recommendations for the future. PMID:27652219

  7. Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force

    PubMed Central

    Powers, John H.; Patrick, Donald L.; Walton, Marc K.; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B.

    2017-01-01

    A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients’ health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient’s health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment—Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation

  8. A proposed set of metrics for standardized outcome reporting in the management of low back pain

    PubMed Central

    Clement, R Carter; Welander, Adina; Stowell, Caleb; Cha, Thomas D; Chen, John L; Davies, Michelle; Fairbank, Jeremy C; Foley, Kevin T; Gehrchen, Martin; Hagg, Olle; Jacobs, Wilco C; Kahler, Richard; Khan, Safdar N; Lieberman, Isador H; Morisson, Beth; Ohnmeiss, Donna D; Peul, Wilco C; Shonnard, Neal H; Smuck, Matthew W; Solberg, Tore K; Stromqvist, Bjorn H; Hooff, Miranda L Van; Wasan, Ajay D; Willems, Paul C; Yeo, William; Fritzell, Peter

    2015-01-01

    Background and purpose Outcome measurement has been shown to improve performance in several fields of healthcare. This understanding has driven a growing interest in value-based healthcare, where value is defined as outcomes achieved per money spent. While low back pain (LBP) constitutes an enormous burden of disease, no universal set of metrics has yet been accepted to measure and compare outcomes. Here, we aim to define such a set. Patients and methods An international group of 22 specialists in several disciplines of spine care was assembled to review literature and select LBP outcome metrics through a 6-round modified Delphi process. The scope of the outcome set was degenerative lumbar conditions. Results Patient-reported metrics include numerical pain scales, lumbar-related function using the Oswestry disability index, health-related quality of life using the EQ-5D-3L questionnaire, and questions assessing work status and analgesic use. Specific common and serious complications are included. Recommended follow-up intervals include 6, 12, and 24 months after initiating treatment, with optional follow-up at 3 months and 5 years. Metrics for risk stratification are selected based on pre-existing tools. Interpretation The outcome measures recommended here are structured around specific etiologies of LBP, span a patient’s entire cycle of care, and allow for risk adjustment. Thus, when implemented, this set can be expected to facilitate meaningful comparisons and ultimately provide a continuous feedback loop, enabling ongoing improvements in quality of care. Much work lies ahead in implementation, revision, and validation of this set, but it is an essential first step toward establishing a community of LBP providers focused on maximizing the value of the care we deliver. PMID:25828191

  9. [Report of a study concerning carry-over in epilepsy patients: questionnaire survey of neurologists].

    PubMed

    Watanabe, Masako; Watanabe, Yutaka; Murata, Yoshiko; Taniguchi, Go; Okazaki, Mitsutoshi

    2012-01-01

    We conducted a questionnaire survey on 7,500 members of the Societas Neurologica Japonica regarding the carry-over from pediatric to adult epilepsy care. The response rate was 16.9%. Analysis of the responses showed that 46% of the neurologists were aware of the term "carry-over" in epilepsy care, and 78% felt difficulties with epilepsy care in general. The most common reasons included "not familiar with interpreting EEG" and "not familiar with the laws, regulations and medical and welfare systems specific to epilepsy". Among the neurologists who felt difficulties when accepting epilepsy patients aged 20 years or older referred from the pediatric department, 68% had experienced accepting these patients. The two major reasons for feeling difficulties when accepting these patients were "difficult to have good understanding of the disease course from infancy" and "not familiar with the epilepsy syndrome specific to infancy". The above findings highlight the importance of recognizing the existence of the issue of carry-over in adult epilepsy care and its significance, and to resolve the factors that hinder the transition of care. To achieve this goal, joint activities of the Japanese Society of Child Neurology and the Japan Epilepsy Society in collaboration with the Societas Neurologica Japonica, the Japanese Society of Psychiatry and Neurology, and the Japan Neurosurgical Society are critical.

  10. Development and Validation of a Self-reported Questionnaire for Measuring Internet Search Dependence.

    PubMed

    Wang, Yifan; Wu, Lingdan; Zhou, Hongli; Xu, Jiaojing; Dong, Guangheng

    2016-01-01

    Internet search has become the most common way that people deal with issues and problems in everyday life. The wide use of Internet search has largely changed the way people search for and store information. There is a growing interest in the impact of Internet search on users' affect, cognition, and behavior. Thus, it is essential to develop a tool to measure the changes in psychological characteristics as a result of long-term use of Internet search. The aim of this study is to develop a Questionnaire on Internet Search Dependence (QISD) and test its reliability and validity. We first proposed a preliminary structure and items of the QISD based on literature review, supplemental investigations, and interviews. And then, we assessed the psychometric properties and explored the factor structure of the initial version via exploratory factor analysis (EFA). The EFA results indicated that four dimensions of the QISD were very reliable, i.e., habitual use of Internet search, withdrawal reaction, Internet search trust, and external storage under Internet search. Finally, we tested the factor solution obtained from EFA through confirmatory factor analysis (CFA). The results of CFA confirmed that the four dimensions model fits the data well. In all, this study suggests that the 12-item QISD is of high reliability and validity and can serve as a preliminary tool to measure the features of Internet search dependence.

  11. Development and Validation of a Self-reported Questionnaire for Measuring Internet Search Dependence

    PubMed Central

    Wang, Yifan; Wu, Lingdan; Zhou, Hongli; Xu, Jiaojing; Dong, Guangheng

    2016-01-01

    Internet search has become the most common way that people deal with issues and problems in everyday life. The wide use of Internet search has largely changed the way people search for and store information. There is a growing interest in the impact of Internet search on users’ affect, cognition, and behavior. Thus, it is essential to develop a tool to measure the changes in psychological characteristics as a result of long-term use of Internet search. The aim of this study is to develop a Questionnaire on Internet Search Dependence (QISD) and test its reliability and validity. We first proposed a preliminary structure and items of the QISD based on literature review, supplemental investigations, and interviews. And then, we assessed the psychometric properties and explored the factor structure of the initial version via exploratory factor analysis (EFA). The EFA results indicated that four dimensions of the QISD were very reliable, i.e., habitual use of Internet search, withdrawal reaction, Internet search trust, and external storage under Internet search. Finally, we tested the factor solution obtained from EFA through confirmatory factor analysis (CFA). The results of CFA confirmed that the four dimensions model fits the data well. In all, this study suggests that the 12-item QISD is of high reliability and validity and can serve as a preliminary tool to measure the features of Internet search dependence. PMID:28066753

  12. Health Services OutPatient Experience questionnaire: factorial validity and reliability of a patient-centered outcome measure for outpatient settings in Italy

    PubMed Central

    Coluccia, Anna; Ferretti, Fabio; Pozza, Andrea

    2014-01-01

    Purpose The patient-centered approach to health care does not seem to be sufficiently developed in the Italian context, and is still characterized by the biomedical model. In addition, there is a lack of validated outcome measures to assess outpatient experience as an aspect common to a variety of settings. The current study aimed to evaluate the factorial validity, reliability, and invariance across sex of the Health Services OutPatient Experience (HSOPE) questionnaire, a short ten-item measure of patient-centeredness for Italian adult outpatients. The rationale for unidimensionality of the measure was that it could cover global patient experience as a process common to patients with a variety of diseases and irrespective of the phase of treatment course. Patients and methods The HSOPE was compiled by 1,532 adult outpatients (51% females, mean age 59.22 years, standard deviation 16.26) receiving care in ten facilities at the Santa Maria alle Scotte University Hospital of Siena, Italy. The sample represented all the age cohorts. Twelve percent were young adults, 57% were adults, and 32% were older adults. Exploratory and confirmatory factor analyses were conducted to evaluate factor structure. Reliability was evaluated as internal consistency using Cronbach’s α. Factor invariance was assessed through multigroup analyses. Results Both exploratory and confirmatory analyses suggested a clearly defined unidimensional structure of the measure, with all the ten items having salient loadings on a single factor. Internal consistency was excellent (α=0.95). Indices of model fit supported a single-factor structure for both male and female outpatient groups. Young adult outpatients had significantly lower scores on perceived patient-centeredness relative to older adults. No significant difference emerged on patient-centeredness between male and female outpatients. Conclusion The HSOPE questionnaire seemed to be a tool with high acceptability and excellent psychometric

  13. Registering initial defaulters and reporting on their treatment outcomes.

    PubMed

    Harries, A D; Rusen, I D; Chiang, C-Y; Hinderaker, S G; Enarson, D A

    2009-07-01

    This Unresolved Issues article highlights three original articles that appeared last year in the Journal discussing the phenomenon of initial defaulters. There are three important challenges with patients that appear in the laboratory sputum register but are not recorded in the tuberculosis (TB) patient register: the first is how to identify these patients, trace them and get them on to treatment as soon as possible; the second is how to register and report on these cases as part of the case-finding component of TB control; and the third is whether to include these initial default patients in the cohort analysis of treatment outcomes. We recommend a step-wise approach to these challenges and advocate that these patients be included, wherever possible, in the TB patient register and in the cohort analysis of treatment outcomes.

  14. The Gutenberg Health Study: measuring psychosocial factors at work and predicting health and work-related outcomes with the ERI and the COPSOQ questionnaire

    PubMed Central

    2013-01-01

    Background Several instruments have been developed to assess psychosocial workload. We compared two of these instruments, the Effort-Reward Imbalance (ERI) model and the Copenhagen Psychosocial Questionnaire (COPSOQ) with regard to congruent validity and internal validity. Methods This analysis is based on a population-based sample of the baseline examination of 2,783 employees from the Gutenberg Health Study (GHS). About half of the participants completed the ERI questionnaire (n = 1,342), the other half completed the COPSOQ (n = 1,441). First, the two samples were compared and descriptive analyses were carried out calculating mean values for both instruments in general, then separately for age, gender and main occupational groups. Second, we analyzed the relationship between ERI and COPSOQ scales on the workplace situation and on the workplace outcomes: job satisfaction, general health, burnout, satisfaction with life, by applying stepwise logistic regression analysis. Results and discussion For the majority of occupations, high effort as reflected by the ERI corresponded with high demands as reflected by the COPSOQ. Comparably, high reward (according to ERI) yielded a good agreement with high “influence and development” (according to COPSOQ). However, we could also find differences between ERI and COPSOQ concerning the intensity of psychosocial workload in some occupations (e.g., physicians/pharmacists or warehouse managers/warehousemen/transport workers). These differences point to differing theoretical concepts of ERI and COPSOQ. When the ability of ERI and COPSOQ was examined to determine the associations with health and work outcomes, burnout could be better predicted by the COPSOQ; this might be due to the fact that COPSOQ comprises the constructs “work-privacy conflict” and “emotional demand”, which are closely related to burnout. However, methodological differences between these instruments limit their direct comparability. Conclusions

  15. The distinction of 'psychosomatogenic family types' based on parents' self reported questionnaire information: a cluster analysis.

    PubMed

    Rousseau, Sofie; Grietens, Hans; Vanderfaeillie, Johan; Ceulemans, Eva; Hoppenbrouwers, Karel; Desoete, Annemie; Van Leeuwen, Karla

    2014-06-01

    The theory of 'psychosomatogenic family types' is often used in treatment of somatizing adolescents. This study investigated the validity of distinguishing 'psychosomatogenic family types' based on parents' self-reported family features. The study included a Flemish general population sample of 12-year olds (n = 1428). We performed cluster analysis on 3 variables concerning parents' self-reported problems in family functioning. The distinguished clusters were examined for differences in marital problems, parental emotional problems, professional help for family members, demographics, and adolescents' somatization. Results showed the existence of 5 family types: 'chaotic family functioning,' 'average amount of family functioning problems,' 'few family functioning problems,' 'high amount of support and communication problems,' and 'high amount of sense of security problems' clusters. Membership of the 'chaotic family functioning' and 'average amount of family functioning problems' cluster was significantly associated with higher levels of somatization, compared with 'few family functioning problems' cluster membership. Among additional variables, only marital and parental emotional problems distinguished somatization relevant from non relevant clusters: parents in 'average amount of family functioning problems' and 'chaotic family functioning' clusters reported higher problems. The data showed that 'apparently perfect' or 'enmeshed' patterns of family functioning may not be assessed by means of parent report as adopted in this study. In addition, not only adolescents from 'extreme' types of family functioning may suffer from somatization. Further, professionals should be careful assuming that families in which parents report average to high amounts of family functioning problems also show different demographic characteristics.

  16. Retrospective Assessment of Behavioral Inhibition in Infants and Toddlers: Development of a Parent Report Questionnaire

    ERIC Educational Resources Information Center

    Gensthaler, A.; Mohler, E.; Resch, F.; Paulus, F.; Schwenck, C.; Freitag, C. M.; Goth, K.

    2013-01-01

    A behaviorally inhibited temperament in early childhood has been identified as a potential risk factor for anxiety disorders in children and adolescents. The purpose of our investigation was the development and evaluation of the factor structure, reliability and validity of the first retrospective parent report measure to assess behavioral…

  17. Freshman to Senior Year Gains Reported on the College Student Experiences Questionnaire.

    ERIC Educational Resources Information Center

    Bauer, Karen W.

    1995-01-01

    Examines differences in quality of effort and self-reported gains students make in academic and personal/social development. Results indicate that students invested more effort in writing, science applications and procedures, and college housing as freshmen, but invested more effort in the library and social interactions as seniors. (JPS)

  18. Negative Effects of Psychological Treatments: An Exploratory Factor Analysis of the Negative Effects Questionnaire for Monitoring and Reporting Adverse and Unwanted Events

    PubMed Central

    Kottorp, Anders; Boettcher, Johanna; Andersson, Gerhard; Carlbring, Per

    2016-01-01

    Research conducted during the last decades has provided increasing evidence for the use of psychological treatments for a number of psychiatric disorders and somatic complaints. However, by focusing only on the positive outcomes, less attention has been given to the potential of negative effects. Despite indications of deterioration and other adverse and unwanted events during treatment, little is known about their occurrence and characteristics. Hence, in order to facilitate research of negative effects, a new instrument for monitoring and reporting their incidence and impact was developed using a consensus among researchers, self-reports by patients, and a literature review: the Negative Effects Questionnaire. Participants were recruited via a smartphone-delivered self-help treatment for social anxiety disorder and through the media (N = 653). An exploratory factor analysis was performed, resulting in a six-factor solution with 32 items, accounting for 57.64% of the variance. The derived factors were: symptoms, quality, dependency, stigma, hopelessness, and failure. Items related to unpleasant memories, stress, and anxiety were experienced by more than one-third of the participants. Further, increased or novel symptoms, as well as lack of quality in the treatment and therapeutic relationship rendered the highest self-reported negative impact. In addition, the findings were discussed in relation to prior research and other similar instruments of adverse and unwanted events, giving credence to the items that are included. The instrument is presently available in eleven different languages and can be freely downloaded and used from www.neqscale.com. PMID:27331907

  19. Negative Effects of Psychological Treatments: An Exploratory Factor Analysis of the Negative Effects Questionnaire for Monitoring and Reporting Adverse and Unwanted Events.

    PubMed

    Rozental, Alexander; Kottorp, Anders; Boettcher, Johanna; Andersson, Gerhard; Carlbring, Per

    2016-01-01

    Research conducted during the last decades has provided increasing evidence for the use of psychological treatments for a number of psychiatric disorders and somatic complaints. However, by focusing only on the positive outcomes, less attention has been given to the potential of negative effects. Despite indications of deterioration and other adverse and unwanted events during treatment, little is known about their occurrence and characteristics. Hence, in order to facilitate research of negative effects, a new instrument for monitoring and reporting their incidence and impact was developed using a consensus among researchers, self-reports by patients, and a literature review: the Negative Effects Questionnaire. Participants were recruited via a smartphone-delivered self-help treatment for social anxiety disorder and through the media (N = 653). An exploratory factor analysis was performed, resulting in a six-factor solution with 32 items, accounting for 57.64% of the variance. The derived factors were: symptoms, quality, dependency, stigma, hopelessness, and failure. Items related to unpleasant memories, stress, and anxiety were experienced by more than one-third of the participants. Further, increased or novel symptoms, as well as lack of quality in the treatment and therapeutic relationship rendered the highest self-reported negative impact. In addition, the findings were discussed in relation to prior research and other similar instruments of adverse and unwanted events, giving credence to the items that are included. The instrument is presently available in eleven different languages and can be freely downloaded and used from www.neqscale.com.

  20. Comparative Effectiveness Study of Patient-Reported Outcomes following Proton Therapy or IMRT for Prostate Cancer

    PubMed Central

    Hoppe, Bradford S.; Michalski, Jeff M.; Mendenhall, Nancy P.; Morris, Christopher G.; Henderson, Randal H.; Nichols, Romaine C.; Mendenhall, William M.; Williams, Christopher; Regan, Meredith M.; Chipman, Jonathan; Crociani, Catrina; Sandler, Howard M.; Sanda, Martin G.; Hamstra, Daniel A.

    2014-01-01

    Background Data continues to emerge on the relative merits of different treatment modalities for prostate cancer. The purpose of this study is to compare patient-reported quality-of-life outcomes (QOL) after proton therapy (PT) and intensity-modulated radiation therapy (IMRT) for prostate cancer. Methods A comparison was performed of prospectively collected QOL data using the expanded prostate cancer index (EPIC) questionnaire. QOL data was collected during the first 2 years following treatment for men treated with PT and IMRT. PT was delivered to 1,243 men at a single center to 76-82Gy. IMRT was delivered to 204 men included in the Prostate Cancer Quality Assurance Study (PROSTQA) in doses of 75.6-79.4Gy.The Wilcoxon rank sum test was used to compare EPIC outcomes by modality using baseline-adjusted scores at different time points. Individual questions were assessed by converting to binary outcomes and testing with generalized estimating equations. Results No differences in changes in summary scores for bowel, urinary incontinence, urinary irritative/obstructive, and sexual domains were seen between the two cohorts. However, more men treated with IMRT reported moderate/big problems with rectal urgency (p=0.02) and frequent bowel movements (p=0.05) than men treated with PT. Conclusions There were no differences in QOL summary scores between the IMRT and PT cohorts during early follow-up up to 2-years. Response to individual questions suggests possible differences in specific bowel symptoms between the two cohorts. These outcomes highlight the need for further comparative studies of PT and IMRT. PMID:24382757

  1. Implementing patient reported outcome measures (PROMs) in palliative care - users' cry for help

    PubMed Central

    2011-01-01

    Background Patient-reported outcome measurement (PROM) plays an increasingly important role in palliative care. A variety of measures exists and is used in clinical care, audit and research. However, little is known about professionals' views using these measures. The aim of this study is to describe the use and experiences of palliative care professionals with outcome measures. Methods A web-based online survey was conducted in Europe and Africa. Professionals working in clinical care, audit and research in palliative care were invited to the survey via national palliative care associations and various databases. Invitation e-mails were sent with a link to the questionnaire. Results Overall participation rate 42% (663/1592), overall completion rate 59% (392/663). The majority of respondents were female (63.4%), mean age 46 years (SD 9). 68.1% respondents from Europe and 73.3% from Africa had experiences with outcome measures in palliative care. Non-users reported time constraints, burden, lack of training and guidance as main reasons. In clinical care/audit, assessment of patients' situation, monitoring changes and evaluation of services were main reasons for use. Choice of OMs for research was influenced by validity of the instrument in palliative care and comparability with international literature. Main problems were related to patient characteristics, staff, and outcome measures. Participants expressed the need for more guidance and training in the use of PROMs. Conclusions Professionals need more support for the use and implementation of PROMs in clinical practice and research through training and guidance in order to improve patient care. PMID:21507232

  2. Feasibility of Frequent Patient-Reported Outcome Surveillance in Patients Undergoing Hematopoietic Cell Transplantation

    PubMed Central

    Wood, William A.; Deal, Allison M.; Abernethy, Amy; Basch, Ethan; Battaglini, Claudio; Kim, Yoon Hie; Whitley, Julia; Shatten, Charlotte; Serody, Jon; Shea, Thomas; Reeve, Bryce B.

    2012-01-01

    Patient-reported outcomes (PROs), including symptoms and health-related quality of life (HRQOL), provide a patient-centered description of hematopoietic cell transplantation (HCT)-related toxicity. These data characterize the patient experience after HCT and may have prognostic usefulness for long-term outcomes after HCT. We conducted a study of 32 patients after HCT (10 autologous HCT recipients, 11 full-intensity conditioning allogeneic HCT recipients, and 11 reduced-intensity conditioning allogeneic HCT recipients) to determine the feasibility of weekly electronic PRO collection from HCT until day (D) + 100. We used questions from the PRO version of the Common Terminology Criteria for Adverse Events to capture symptoms, and the Patient-Reported Outcomes Measurement Information System Global Health scale to measure physical and mental HRQOL. The vast majority (94%) of patients used the electronic PRO system, with only 6% opting for paper-and-pencil only. The median weekly percentage of participants who completed the surveys was 100% in all cohorts through hospital discharge, and remained 100% for the autologous HCT and reduced-intensity allogeneic HCT cohorts through D+100. Patients were satisfied with the electronic system, giving high marks for readability, comfort, and questionnaire length. Symptom severity varied by absolute level and type of symptom across the 3 cohorts, with the full-intensity allogeneic HCT cohort exhibiting the greatest median overall symptom severity, peaking at D+7. Median physical health HRQOL scores decreased with time in the 3 cohorts, and HRQOL was generally correlated with overall symptom severity. Our results demonstrate the feasibility of frequent electronic PROs in the early post-HCT period. Future studies in larger populations to explore predictive models using frequent PRO data for outcomes, including long-term HRQOL and survival, are warranted. PMID:23253558

  3. Patient-reported outcome measures in arthroplasty registries

    PubMed Central

    Eresian Chenok, Kate; Bohm, Eric; Lübbeke, Anne; Denissen, Geke; Dunn, Jennifer; Lyman, Stephen; Franklin, Patricia; Dunbar, Michael; Overgaard, Søren; Garellick, Göran; Dawson, Jill

    2016-01-01

    The International Society of Arthroplasty Registries (ISAR) Steering Committee established the Patient-Reported Outcome Measures (PROMs) Working Group to convene, evaluate, and advise on best practices in the selection, administration, and interpretation of PROMs and to support the adoption and use of PROMs for hip and knee arthroplasty in registries worldwide. The 2 main types of PROMs include generic (general health) PROMs, which provide a measure of general health for any health state, and specific PROMs, which focus on specific symptoms, diseases, organs, body regions, or body functions. The establishment of a PROM instrument requires the fulfillment of methodological standards and rigorous testing to ensure that it is valid, reliable, responsive, and acceptable to the intended population. A survey of the 41 ISAR member registries showed that 8 registries administered a PROMs program that covered all elective hip or knee arthroplasty patients and 6 registries collected PROMs for sample populations; 1 other registry had planned but had not started collection of PROMs. The most common generic instruments used were the EuroQol 5 dimension health outcome survey (EQ-5D) and the Short Form 12 health survey (SF-12) or the similar Veterans RAND 12-item health survey (VR-12). The most common specific PROMs were the Hip disability and Osteoarthritis Outcome Score (HOOS), the Knee injury and Osteoarthritis Outcome Score (KOOS), the Oxford Hip Score (OHS), the Oxford Knee Score (OKS), the Western Ontario and McMaster Universities Arthritis Index (WOMAC), and the University of California at Los Angeles Activity Score (UCLA). PMID:27168175

  4. Patient-Reported Outcomes Are Changing the Landscape in Oncology Care: Challenges and Opportunities for Payers

    PubMed Central

    Zagadailov, Erin; Fine, Michael; Shields, Alan

    2013-01-01

    Background A patient-reported outcome (PRO) is a subjective report that comes from a patient without interpretation by a clinician. Because of the increasingly significant role of PROs in the development and evaluation of new medicines, the US Food and Drug Administration (FDA) issued a formal guidance to describe how PRO instruments will be reviewed and evaluated with respect to claims in approved medical product labeling. Meanwhile, PROs continue to appear in oncology clinical trials more frequently; however, it is unclear how payers and policymakers can use PRO data in the context of decision-making for cancer treatments. Objective The objective of this article is to discuss the challenges and opportunities of incorporating oncology-related PRO data into payer decision-making. Discussion Payer concerns with PRO instruments are often related to issues regarding measurement, relevance, quality, and interpretability of PROs. Payers may dismiss PROs that do not independently predict improved outcomes. The FDA guidance released in 2009 demonstrates, as evidenced by the case of ruxolitinib, how PRO questionnaires can be generated in a relevant, trustworthy, and meaningful way, which provides an opportunity for payers and policy decision makers to focus on how to use PRO data in their decision-making. This is particularly relevant in oncology, where a recent and sizable number of clinical trials include PRO measures. Conclusion As an increasing number of oncology medications enter the market with product labeling claims that contain PRO data, payers will need to better familiarize themselves with the opportunities associated with PRO questionnaires when making coverage decisions. PRO measures will continue to provide valuable information regarding the risk–benefit profile of novel agents. As such, PRO measures may provide evidence that should be considered in payers' decisions and discussions; however, the formal role of PROs and the pertinence of PROs in decision

  5. Patient reported outcomes and patient empowerment in clinical genetics services.

    PubMed

    McAllister, M; Dearing, A

    2015-08-01

    Evaluation of clinical genetics services (CGS), including genetic counseling and genetic testing, has been problematic. Patient mortality and morbidity are unlikely to be directly improved by interventions offered in CGS. Patient-reported outcomes (PROs) are not routinely measured in CGS evaluation, but this may change as patient-reported outcome measures (PROMs) become a key part of how healthcare services are managed and funded across the world. However, there is no clear consensus about which PROMs are most useful for CGS evaluation. This review summarizes the published research on how PROs from CGS have been measured and how patients may benefit from using those services, with a focus on patient empowerment. Many patient benefits (PROs) identified repeatedly in the research literature can be re-interpreted within a patient empowerment framework. Other important PROs identified include family functioning, social functioning, altruism, sense of purpose, enabling development of future research and treatment/participating in research. Well-validated measures are available to capture (dimensions of) patient empowerment. Although generic measures of family functioning are available, suitable measures capturing social functioning, development of future treatments, and altruism were not identified in this review. Patient empowerment provides one useful approach to measuring PROs from CGS.

  6. The Patient-Reported Outcomes Measurement Information System (PROMIS)

    PubMed Central

    Cella, David; Yount, Susan; Rothrock, Nan; Gershon, Richard; Cook, Karon; Reeve, Bryce; Ader, Deborah; Fries, James F.; Bruce, Bonnie; Rose, Mattias

    2010-01-01

    Background The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Roadmap initiative (www.nihpromis.org) is a 5-year cooperative group program of research designed to develop, validate, and standardize item banks to measure patient-reported outcomes (PROs) relevant across common medical conditions. In this article, we will summarize the organization and scientific activity of the PROMIS network during its first 2 years. Design The network consists of 6 primary research sites (PRSs), a statistical coordinating center (SCC), and NIH research scientists. Governed by a steering committee, the network is organized into functional subcommittees and working groups. In the first year, we created an item library and activated 3 interacting protocols: Domain Mapping, Archival Data Analysis, and Qualitative Item Review (QIR). In the second year, we developed and initiated testing of item banks covering 5 broad domains of self-reported health. Results The domain mapping process is built on the World Health Organization (WHO) framework of physical, mental, and social health. From this framework, pain, fatigue, emotional distress, physical functioning, social role participation, and global health perceptions were selected for the first wave of testing. Item response theory (IRT)-based analysis of 11 large datasets supplemented and informed item-level qualitative review of nearly 7000 items from available PRO measures in the item library. Items were selected for rewriting or creation with further detailed review before the first round of testing in the general population and target patient populations. Conclusions The NIH PROMIS network derived a consensus-based framework for self-reported health, systematically reviewed available instruments and datasets that address the initial PROMIS domains. Qualitative item research led to the first wave of network testing which began in the second year. PMID:17443116

  7. Designing of Intelligent Multilingual Patient Reported Outcome System (IMPROS)

    PubMed Central

    Pourasghar, Faramarz; Partovi, Yeganeh

    2015-01-01

    Background: By self-reporting outcome procedure the patients themselves record disease symptoms outside medical centers and then report them to medical staff in specific periods of time. One of the self-reporting methods is the application of interactive voice response (IVR), in which some pre-designed questions in the form of voice tracks would be played and then the caller responses the questions by pressing phone’s keypad bottoms. Aim: The present research explains the main framework of such system designing according to IVR technology that is for the first time designed and administered in Iran. Methods: Interactive Voice Response system was composed by two main parts of hardware and software. Hardware section includes one or several digital phone lines, a modem card with voice playing capability and a PC. IVR software on the other hand, acts as an intelligent control center, records call information and controls incoming data. Results: One of the main features of the system is its capability to be administered in common PCs, utilizing simple and cheap modems, high speed to take responses and it’s appropriateness to low literate patients. The system is applicable for monitoring chronic diseases, cancer and also in psychological diseases and can be suitable for taking care of elders and Children who require long term cares. Other features include user-friendly, decrease in direct and indirect costs of disease treatment and enjoying from high level of security to access patients’ profiles. Conclusions: Intelligent multilingual patient reported outcome system (IMPROS) by controlling diseases gives the opportunity to patients to have more participation during treatment and it improves mutual interaction between patient and medical staff. Moreover it increases the quality of medical services, Additional to empowering patients and their followers. PMID:26635441

  8. Impact of Communicating Familial Risk of Diabetes on Illness Perceptions and Self-Reported Behavioral Outcomes

    PubMed Central

    Pijl, Miranda; Timmermans, Danielle R.M.; Claassen, Liesbeth; Janssens, A. Cecile J.W.; Nijpels, Giel; Dekker, Jacqueline M.; Marteau, Theresa M.; Henneman, Lidewij

    2009-01-01

    OBJECTIVE To assess the potential effectiveness of communicating familial risk of diabetes on illness perceptions and self-reported behavioral outcomes. RESEARCH DESIGN AND METHODS Individuals with a family history of diabetes were randomized to receive risk information based on familial and general risk factors (n = 59) or general risk factors alone (n = 59). Outcomes were assessed using questionnaires at baseline, 1 week, and 3 months. RESULTS Compared with individuals receiving general risk information, those receiving familial risk information perceived heredity to be a more important cause of diabetes (P < 0.01) at 1-week follow-up, perceived greater control over preventing diabetes (P < 0.05), and reported having eaten more healthily (P = 0.01) after 3 months. Behavioral intentions did not differ between the groups. CONCLUSIONS Communicating familial risk increased personal control and, thus, did not result in fatalism. Although the intervention did not influence intentions to change behavior, there was some evidence to suggest it increases healthy behavior. PMID:19131458

  9. Establishing Core Outcome Domains in Hemodialysis: Report of the Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Consensus Workshop.

    PubMed

    Tong, Allison; Manns, Braden; Hemmelgarn, Brenda; Wheeler, David C; Evangelidis, Nicole; Tugwell, Peter; Crowe, Sally; Van Biesen, Wim; Winkelmayer, Wolfgang C; O'Donoghue, Donal; Tam-Tham, Helen; Shen, Jenny I; Pinter, Jule; Larkins, Nicholas; Youssouf, Sajeda; Mandayam, Sreedhar; Ju, Angela; Craig, Jonathan C

    2017-01-01

    Evidence-informed decision making in clinical care and policy in nephrology is undermined by trials that selectively report a large number of heterogeneous outcomes, many of which are not patient centered. The Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Initiative convened an international consensus workshop on November 7, 2015, to discuss the identification and implementation of a potential core outcome set for all trials in hemodialysis. The purpose of this article is to report qualitative analyses of the workshop discussions, describing the key aspects to consider when establishing core outcomes in trials involving patients on hemodialysis therapy. Key stakeholders including 8 patients/caregivers and 47 health professionals (nephrologists, policymakers, industry, and researchers) attended the workshop. Attendees suggested that identifying core outcomes required equitable stakeholder engagement to ensure relevance across patient populations, flexibility to consider evolving priorities over time, deconstruction of language and meaning for conceptual consistency and clarity, understanding of potential overlap and associations between outcomes, and an assessment of applicability to the range of interventions in hemodialysis. For implementation, they proposed that core outcomes must have simple, inexpensive, and validated outcome measures that could be used in clinical care (quality indicators) and trials (including pragmatic trials) and endorsement by regulatory agencies. Integrating these recommendations may foster acceptance and optimize the uptake and translation of core outcomes in hemodialysis, leading to more informative research, for better treatment and improved patient outcomes.

  10. Predictive validity of self-report questionnaires in the assessment of autism spectrum disorders in adults.

    PubMed

    Sizoo, Bram B; Horwitz, E H; Teunisse, J P; Kan, C C; Vissers, Ctwm; Forceville, Ejm; Van Voorst, Ajp; Geurts, H M

    2015-10-01

    While various screening instruments for autism spectrum disorders are widely used in diagnostic assessments, their psychometric properties have not been simultaneously evaluated in the outpatient setting where these instruments are used most. In this study, we tested the Ritvo Autism Asperger Diagnostic Scale-Revised and two short versions of the Autism-Spectrum Quotient, the AQ-28 and AQ-10, in 210 patients referred for autism spectrum disorder assessment and in 63 controls. Of the 210 patients, 139 received an autism spectrum disorder diagnosis and 71 received another psychiatric diagnosis. The positive predictive values indicate that these tests correctly identified autism spectrum disorder patients in almost 80% of the referred cases. However, the negative predictive values suggest that only half of the referred patients without autism spectrum disorder were correctly identified. The sensitivity and specificity of each of these instruments were much lower than the values reported in the literature. In this study, the sensitivity of the Ritvo Autism Asperger Diagnostic Scale-Revised was the highest (73%), and the Autism-Spectrum Quotient short forms had the highest specificity (70% and 72%). Based on the similar area under the curve values, there is no clear preference for any of the three instruments. None of these instruments have sufficient validity to reliably predict a diagnosis of autism spectrum disorder in outpatient settings.

  11. The McGill Pain Questionnaire in Amharic: Zwai Health Center patients' reports on the experience of pain.

    PubMed

    Aboud, Frances E; Hiwot, Mismay G; Arega, Adefris; Molla, Mesfin; Samson, S; Seyoum, Nebyou; Ressom, Shewangizaw; Worku, Solomon; Mulatu, Mesfin; Egale, Tewedros

    2003-01-01

    This paper presents for the first time an Amharic translation of the McGill Pain Questionnaire developed by Melzack and used in many countries around the world. It allows for a quantitative and qualitative assessment of the intensity, location, and nature of experienced pain, as well as conditions that relieve pain. Data collected from one hundred patients attending the Zwai Health Center indicated that 81% reported pain at the time, one-quarter of whom were in severe pain. The most commonly chosen descriptors were: burning, stabbing, sore, gnawing, aching, and cramping. Descriptors were often associated with certain diagnoses: burning with gastrointestinal problems, stabbing with respiratory diseases, and gnawing or aching with myalgia/neuralgia. Approximately 40% of those in pain had previously sought relief from a clinic or pharmacy and were attending the center because the pain persisted. Analgesics were more likely to be prescribed for those in mild pain, while other medication without analgesics were prescribed for those in severe pain. The McGill Pain Questionnaire--Amharic (MPQ-Am) could be a useful tool for future studies of illness-specific pain, and of the effectiveness of pharmaceutical and non-pharmaceutical strategies for pain management.

  12. "Not just little adults": qualitative methods to support the development of pediatric patient-reported outcomes.

    PubMed

    Arbuckle, Rob; Abetz-Webb, Linda

    2013-01-01

    The US FDA and the European Medicines Agency (EMA) have issued incentives and laws mandating clinical research in pediatrics. While guidances for the development and validation of patient-reported outcomes (PROs) or health-related quality of life (HRQL) measures have been issued by these agencies, little attention has focused on pediatric PRO development methods. With reference to the literature, this article provides an overview of specific considerations that should be made with regard to the development of pediatric PRO measures, with a focus on performing qualitative research to ensure content validity. Throughout the questionnaire development process it is critical to use developmentally appropriate language and techniques to ensure outcomes have content validity, and will be reliable and valid within narrow age bands (0-2, 3-5, 6-8, 9-11, 12-14, 15-17 years). For qualitative research, sample sizes within those age bands must be adequate to demonstrate saturation while taking into account children's rapid growth and development. Interview methods, interview guides, and length of interview must all take developmental stage into account. Drawings, play-doh, or props can be used to engage the child. Care needs to be taken during cognitive debriefing, where repeated questioning can lead a child to change their answers, due to thinking their answer is incorrect. For the PROs themselves, the greatest challenge is in measuring outcomes in children aged 5-8 years. In this age range, while self-report is generally more valid, parent reports of observable behaviors are generally more reliable. As such, 'team completion' or a parent-administered child report is often the best option for children aged 5-8 years. For infants and very young children (aged 0-4 years), patient rating of observable behaviors is necessary, and, for adolescents and children aged 9 years and older, self-reported outcomes are generally valid and reliable. In conclusion, the development of PRO

  13. Utility of Washington Early Recognition Center Self-Report Screening Questionnaires in the Assessment of Patients with Schizophrenia and Bipolar Disorder

    PubMed Central

    Hsieh, Christina J.; Godwin, Douglass; Mamah, Daniel

    2016-01-01

    Early identification and treatment are associated with improved outcomes in bipolar disorder (BPD) and schizophrenia (SCZ). Screening for the presence of these disorders usually involves time-intensive interviews that may not be practical in settings where mental health providers are limited. Thus, individuals at earlier stages of illness are often not identified. The Washington Early Recognition Center Affectivity and Psychosis (WERCAP) screen is a self-report questionnaire originally developed to identify clinical risk for developing bipolar or psychotic disorders. The goal of the current study was to investigate the utility of the WERCAP Screen and two complementary questionnaires, the WERC Stress Screen and the WERC Substance Screen, in identifying individuals with established SCZ or BPD. Participants consisted of 35 BPD and 34 SCZ patients, as well as 32 controls (CON), aged 18–30 years. Univariate analyses were used to test for score differences between groups. Logistic regression and receiver operating characteristic (ROC) curves were used to identify diagnostic predictors. Significant group differences were found for the psychosis section of the WERCAP (pWERCAP; p < 0.001), affective section of the WERCAP (aWERCAP; p = 0.001), and stress severity (p = 0.027). No significant group differences were found in the rates of substance use as measured by the WERC Substance Screen (p = 0.267). Only the aWERCAP and pWERCAP scores were useful predictors of diagnostic category. ROC curve analysis showed the optimal cut point on the aWERCAP to identify BPD among our participant groups was a score of >20 [area under the curve (AUC): 0.87; sensitivity: 0.91; specificity: 0.71], while that for the pWERCAP to identify SCZ was a score of >13 (AUC: 0.89; sensitivity: 0.88; specificity: 0.82). These results indicate that the WERCAP Screen may be useful in screening individuals for BPD and SCZ and that identifying stress and substance-use severity can be

  14. Comparing a tablet computer and paper forms for assessing patient-reported outcomes in edentulous patients

    PubMed Central

    Caetano, Thais Angelina; Ribeiro, Adriana Barbosa; Della Vecchia, Maria Paula; Cunha, Tatiana Ramirez; Chaves, Carolina de Andrade Lima

    2016-01-01

    PURPOSE The aim of this study was to determine whether two methods of documentation, print and electronic forms, for the assessment of patient-reported outcomes (PRO) in complete denture wearers provide comparable results. The study also quantified the time needed for filling the forms by each method. MATERIALS AND METHODS Thirty participants enrolled in a university clinic answered two forms (a questionnaire for denture satisfaction and OHIP-EDENT). They provided answers with two application methods in a random order, with a one-month interval between them: (1) electronic forms on a tablet computer; and (2) print forms. The methods were compared in terms of mean results, correlation/agreement, internal consistency, and spent time. RESULTS Mean results for both methods were similar for each denture satisfaction item (100-mm VAS) and OHIP-EDENT summary score. Both questionnaires presented good internal consistency regardless of the application method (Cronbach's α=0.86 or higher). Correlation and agreement between the methods regarding specific items was at least moderate for the majority of cases. Mean time for the electronic and print forms were 9.2 and 8.5 minutes, respectively (paired t test, P=.06, non-significant). CONCLUSION The electronic method is comparable to print forms for the assessment of important PRO of prosthetic treatment for edentulism, considering the results and time needed. Findings suggest the viability of replacing print forms with a tablet for applying the tested inventories in clinical trials. PMID:28018563

  15. Patient-Reported Outcomes in Metastatic Breast Cancer: A Review of Industry-Sponsored Clinical Trials

    PubMed Central

    Krohe, Meaghan; Hao, Yanni; Lamoureux, Roger E.; Galipeau, Nina; Globe, Denise; Foley, Catherine; Mazar, Iyar; Solomon, Jeffrey; Shields, Alan L.

    2016-01-01

    INTRODUCTION Patient-reported outcome (PRO) measures serve to capture vital patient information not otherwise obtained by primary study endpoints. This paper examines how PROs are utilized as endpoints in industry-sponsored metastatic breast cancer clinical trials. METHODS A search was conducted in the clinicaltrials.gov web site for trials involving common treatments for metastatic breast cancer. Thirty-eight clinical trials were identified which included a PRO endpoint in the study, and data were extracted and summarized. RESULTS Overall, 17 unique PRO questionnaires and 14 concepts of measurement were identified as secondary or exploratory endpoints. The Functional Assessment of Cancer Therapy—Breast was the most frequently utilized questionnaire, commonly implemented to assess quality of life. The EORTC QLQ-C30 was also frequently used to measure quality of life or pain. CONCLUSION This review shares insights into the role of PROs in trials for metastatic breast cancer from which treatment developers and other stakeholders can enhance successful implementation of the patient voice into future trials. PMID:27441001

  16. The International Dermatology Outcome Measures initiative as applied to psoriatic disease outcomes: a report from the GRAPPA 2013 meeting.

    PubMed

    Gottlieb, Alice B; Armstrong, April W; Christensen, Robin; Garg, Amit; Duffin, Kristina Callis; Boehncke, Wolf-Henning; Merola, Joseph F; Gladman, Dafna D; Mease, Philip J; Swerlick, Robert A; Rosen, Cheryl F; Abernethy, April

    2014-06-01

    In the United States, access to care is the number one issue facing our patients with dermatological conditions. In part, this is because we do not have outcome measures that are useful in clinical practice and available in databases where payers and governmental agencies can compare the performance of physicians and treatments. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials and subsequently in clinical practice. The International Dermatology Outcome Measures group includes all willing stakeholders: patients, physicians, payers, and pharmaceutical scientists. As reported herein, the group's goal is to develop outcome measures in dermatology that address the needs of all involved.

  17. Assessing Repetitive Negative Thinking Using Categorical and Transdiagnostic Approaches: A Comparison and Validation of Three Polish Language Adaptations of Self-Report Questionnaires

    PubMed Central

    Kornacka, Monika; Buczny, Jacek; Layton, Rebekah L.

    2016-01-01

    Repetitive negative thinking (RNT) is a transdiagnostic process involved in the risk, maintenance, and relapse of serious conditions including mood disorders, anxiety, eating disorders, and addictions. Processing mode theory provides a theoretical model to assess, research, and treat RNT using a transdiagnostic approach. Clinical researchers also often employ categorical approaches to RNT, including a focus on depressive rumination or worry, for similar purposes. Three widely used self-report questionnaires have been developed to assess these related constructs: the Ruminative Response Scale (RRS), the Perseverative Thinking Questionnaire (PTQ), and the Mini-Cambridge Exeter Repetitive Thought Scale (Mini-CERTS). Yet these scales have not previously been used in conjunction, despite useful theoretical distinctions only available in Mini-CERTS. The present validation of the methods in a Polish speaking population provides psychometric parameters estimates that contribute to current efforts to increase reliable replication of theoretical outcomes. Moreover, the following study aims to present particular characteristics and a comparison of the three methods. Although there has been some exploration of a categorical approach, the comparison of transdiagnostic methods is still lacking. These methods are particularly relevant for developing and evaluating theoretically based interventions like concreteness training, an emerging field of increasing interest, which can be used to address the maladaptive processing mode in RNT that can lead to depression and other disorders. Furthermore, the translation of these measures enables the examination of possible cross-cultural structural differences that may lead to important theoretical progress in the measurement and classification of RNT. The results support the theoretical hypothesis. As expected, the dimensions of brooding, general repetitive negative thinking, as well as abstract analytical thinking, can all be classified

  18. Assessing Repetitive Negative Thinking Using Categorical and Transdiagnostic Approaches: A Comparison and Validation of Three Polish Language Adaptations of Self-Report Questionnaires.

    PubMed

    Kornacka, Monika; Buczny, Jacek; Layton, Rebekah L

    2016-01-01

    Repetitive negative thinking (RNT) is a transdiagnostic process involved in the risk, maintenance, and relapse of serious conditions including mood disorders, anxiety, eating disorders, and addictions. Processing mode theory provides a theoretical model to assess, research, and treat RNT using a transdiagnostic approach. Clinical researchers also often employ categorical approaches to RNT, including a focus on depressive rumination or worry, for similar purposes. Three widely used self-report questionnaires have been developed to assess these related constructs: the Ruminative Response Scale (RRS), the Perseverative Thinking Questionnaire (PTQ), and the Mini-Cambridge Exeter Repetitive Thought Scale (Mini-CERTS). Yet these scales have not previously been used in conjunction, despite useful theoretical distinctions only available in Mini-CERTS. The present validation of the methods in a Polish speaking population provides psychometric parameters estimates that contribute to current efforts to increase reliable replication of theoretical outcomes. Moreover, the following study aims to present particular characteristics and a comparison of the three methods. Although there has been some exploration of a categorical approach, the comparison of transdiagnostic methods is still lacking. These methods are particularly relevant for developing and evaluating theoretically based interventions like concreteness training, an emerging field of increasing interest, which can be used to address the maladaptive processing mode in RNT that can lead to depression and other disorders. Furthermore, the translation of these measures enables the examination of possible cross-cultural structural differences that may lead to important theoretical progress in the measurement and classification of RNT. The results support the theoretical hypothesis. As expected, the dimensions of brooding, general repetitive negative thinking, as well as abstract analytical thinking, can all be classified

  19. Long-term result and patient reported outcome of wrist splint treatment for carpal tunnel syndrome.

    PubMed

    Povlsen, Bo; Bashir, Muhammad; Wong, Fabian

    2014-06-01

    Carpal tunnel syndrome (CTS) is the commonest peripheral neuropathy presenting to specialist hand and wrist clinics. This study investigated the long-term outcome of carpal tunnel syndrome treated with isolated night wrist splint and the factors determining the likelihood of success of this intervention. Seventy-five patients referred to a specialist hand clinic with CTS were given night wrist splint treatment for 3 months as per a previous study protocol. Fifty-two patients from this cohort did not wish to have surgery after wrist splint treatment and were followed for a further 33-month period. Baseline pain and numbness levels were recorded on a Visual Analogue Scale (VAS) using a questionnaire upon first presentation. A further questionnaire at 36 months reassessed pain and numbness levels, patients' satisfaction with the treatment, and whether they had subsequent surgical decompression. Of the patients who completed the follow-up questionnaire 33 months after their period of conservative management, 43% were successfully treated with splint treatment alone. There was no difference in the VAS for pain or numbness at the baseline and at 36 months between successful and failed treatment groups. Patients successfully treated with wrist splinting alone reported a higher level of satisfaction with their treatment compared to patients who failed wrist splint treatment or had surgical decompression. The results reinforce the previous recommendation on wrist splinting as a first-line treatment in the Primary Care setting. Referral to specialist hand and wrist clinics should be reserved for patients with symptoms refractory to this initial measure.

  20. Overcoming barriers to implementing patient-reported outcomes in an electronic health record: a case report

    PubMed Central

    Listhaus, Alyson; Covarrubias, Constanza M; Schmidt, Siegfried OF; Mackey, Sean; Carek, Peter J; Fillingim, Roger B; Hurley, Robert W

    2016-01-01

    In this case report, the authors describe the implementation of a system for collecting patient-reported outcomes and integrating results in an electronic health record. The objective was to identify lessons learned in overcoming barriers to collecting and integrating patient-reported outcomes in an electronic health record. The authors analyzed qualitative data in 42 documents collected from system development meetings, written feedback from users, and clinical observations with practice staff, providers, and patients. Guided by the Unified Theory on the Adoption and Use of Information Technology, 5 emergent themes were identified. Two barriers emerged: (i) uncertain clinical benefit and (ii) time, work flow, and effort constraints. Three facilitators emerged: (iii) process automation, (iv) usable system interfaces, and (v) collecting patient-reported outcomes for the right patient at the right time. For electronic health record-integrated patient-reported outcomes to succeed as useful clinical tools, system designers must ensure the clinical relevance of the information being collected while minimizing provider, staff, and patient burden. PMID:26159464

  1. Overcoming barriers to implementing patient-reported outcomes in an electronic health record: a case report.

    PubMed

    Harle, Christopher A; Listhaus, Alyson; Covarrubias, Constanza M; Schmidt, Siegfried Of; Mackey, Sean; Carek, Peter J; Fillingim, Roger B; Hurley, Robert W

    2016-01-01

    In this case report, the authors describe the implementation of a system for collecting patient-reported outcomes and integrating results in an electronic health record. The objective was to identify lessons learned in overcoming barriers to collecting and integrating patient-reported outcomes in an electronic health record. The authors analyzed qualitative data in 42 documents collected from system development meetings, written feedback from users, and clinical observations with practice staff, providers, and patients. Guided by the Unified Theory on the Adoption and Use of Information Technology, 5 emergent themes were identified. Two barriers emerged: (i) uncertain clinical benefit and (ii) time, work flow, and effort constraints. Three facilitators emerged: (iii) process automation, (iv) usable system interfaces, and (v) collecting patient-reported outcomes for the right patient at the right time. For electronic health record-integrated patient-reported outcomes to succeed as useful clinical tools, system designers must ensure the clinical relevance of the information being collected while minimizing provider, staff, and patient burden.

  2. Patient-reported outcomes in stuttering treatment: conceptual framework.

    PubMed

    Franic, Duska M; Bothe, Anne K

    2008-04-01

    Evaluation of: Yaruss JS, Quesal RW. Overall Assessment of the Speaker's Experience of Stuttering (OASES): documenting multiple outcomes in stuttering treatment. J. Fluency Disord. 31(2), 90-115 (2006) [1] . These authors presented the first complete instrument intended to measure the impact of stuttering in adults who stutter (Overall Assessment of the Speaker's Experience of Stuttering; [OASES]). OASES is a 100-item self-report metric with four sections: general information, reactions to stuttering, communication in daily situations and quality of life. Its conceptual framework includes historic views of the influence of emotional and cognitive variables on stuttering; the WHO's International Classification of Impairments, Disabilities and Handicaps (ICIDH); and the WHO's International Classification of Functioning, Disability and Health (ICF). However, both this conceptual framework and the psychometric data presented to support the OASES are problematic in ways that clinicians and researchers in areas well-beyond stuttering may find informative as they consider their own applications.

  3. Electronic multidimensional health assessment questionnaire (eMDHAQ): past, present and future of a proposed single data management system for clinical care, research, quality improvement, and monitoring of long-term outcomes.

    PubMed

    Pincus, Theodore

    2016-01-01

    An MDHAQ/RAPID3 (multidimensional health assessment questionnaire/routine assessment of patient index data) was developed from the HAQ over 25 years, based on observations made from completion by every patient (with all diagnoses) at every routine rheumatology visit since 1980. Modification of the HAQ was viewed as similar to improving a laboratory test, with a primary focus on clinical value for diagnosis, prognosis, and/or management, as well as feasibility for minimal effect on clinical workflow. Rigorous attention, was also directed to validity, reliability, other methodologic and technological considerations, but after clinical value and feasibility were established. A longer "intake" MDHAQ was introduced for new patients to record a complete past medical history - illnesses, hospitalisations, surgeries, allergies, family history, social history and medications. MDHAQ scales not found on the HAQ record complex activities, sleep quality, anxiety, depression, self-report joint count, fatigue, symptom checklist, morning stiffness, exercise status, recent medical history, social history and demographic data within 2 pages on one sheet of paper. An electronic eMDHAQ/RAPID3 provides a similar platform to pool data from multiple sites. A patient may be offered a patient-administered, password-protected, secure, web site, to store the medical history completed on the eMDHAQ. This eMDHAQ would allow a patient to complete a single general medical history questionnaire rather than different intake questionnaires in different medical settings. The eMDHAQ would be available for updates and correction by the patient for future visits, regardless of electronic medical record (EMR). The eMDHAQ is designed to interface with an EMR using HL7 (health level seven) and SMART (Substitutable Medical Apps, Reusable Technology) on FHIR (Fast Healthcare Interoperability Resources), although implementation requires collaboration with the EMR vendor. Advanced features include reports for

  4. Surgical outcome of spinal neurilemmoma: two case reports.

    PubMed

    Yeh, Kuang-Ting; Lee, Ru-Ping; Yu, Tzai-Chiu; Chen, Ing-Ho; Peng, Cheng-Huan; Liu, Kuan-Lin; Wang, Jen-Hung; Wu, Wen-Tien

    2015-02-01

    Neurilemmoma commonly occurs from the fourth to sixth decades of life with an incidence of 3 to 10 per 100,000 people, and is rare in adolescence. This case report describes the clinical and radiographic features of 2 rare cases with intraspinal neurilemmoma of the cervical and thoracic spine. A 29-year-old man who experienced middle back pain with prominent right lower limb weakness, and an 11-year-old boy who suffered from sudden onset neck pain with left arm weakness and hand clawing for 2 weeks before admission to our department were included in this case report. Magnetic resonance imaging of both patients revealed an intraspinal mass causing spinal cord compression at the cervical and thoracic spine. The patients subsequently received urgent posterior spinal cord decompression and tumor resection surgery. The histopathology reports revealed neurilemmoma. The 2 patients recovered and resumed their normal lives within 1 year. Intraspinal neurilemmoma is rare but should be considered in the differential diagnosis of spinal cord compression. Advances in imaging techniques and surgical procedures have yielded substantially enhanced clinical outcomes in intraspinal neoplasm cases. Delicate preoperative study and surgical skill with rehabilitation and postoperative observation are critical.

  5. Addressing Missing Data in Patient-Reported Outcome Measures (PROMS): Implications for the Use of PROMS for Comparing Provider Performance.

    PubMed

    Gomes, Manuel; Gutacker, Nils; Bojke, Chris; Street, Andrew

    2016-05-01

    Patient-reported outcome measures (PROMs) are now routinely collected in the English National Health Service and used to compare and reward hospital performance within a high-powered pay-for-performance scheme. However, PROMs are prone to missing data. For example, hospitals often fail to administer the pre-operative questionnaire at hospital admission, or patients may refuse to participate or fail to return their post-operative questionnaire. A key concern with missing PROMs is that the individuals with complete information tend to be an unrepresentative sample of patients within each provider and inferences based on the complete cases will be misleading. This study proposes a strategy for addressing missing data in the English PROM survey using multiple imputation techniques and investigates its impact on assessing provider performance. We find that inferences about relative provider performance are sensitive to the assumptions made about the reasons for the missing data.

  6. How bad is bile acid diarrhoea: an online survey of patient-reported symptoms and outcomes

    PubMed Central

    Bannaga, Ayman; Kelman, Lawrence; O'Connor, Michelle; Pitchford, Claire; Walters, Julian R F; Arasaradnam, Ramesh P

    2017-01-01

    Objectives Bile acid diarrhoea (BAD) is an underdiagnosed condition producing diarrhoea, urgency and fear of faecal incontinence. How patients experience these symptoms has not previously been studied. Bile Acid Malabsorption (BAM) Support UK was established in 2015 as a national charity with objectives including to provide details regarding how BAD affects patients, to improve earlier recognition and clinical management. Design, setting and main outcome A questionnaire was collected anonymously by BAM Support UK and the Bile Salt Malabsorption Facebook group over 4 weeks at the end of 2015. It comprised 56 questions and aimed to inform patients and clinicians about how BAD affects the respondents. Results The first 100 responses were analysed. 91% of the respondents reported a diagnosis of BAD. 58% of total respondents diagnosed following a Selenium-homocholic acid taurine scan, 69% were diagnosed by a gastroenterologist, with type 2 and 3 BAD comprising 38% and 37%, respectively, of total respondents. Symptoms had been experienced for more than 5 years before diagnosis in 44% of respondents. Following treatment, usually with bile acid sequestrants, 60% of participants reported improvement of diarrhoea and most reported their mental health has been positively impacted. Just over half of the cohort felt as though their symptoms had been dismissed during clinical consultations and 28% felt their GPs were unaware of BAD. Conclusions BAD requires more recognition by clinicians to address the current delays in diagnosis. Treatment improves physical and mental symptoms in the majority of participants. PMID:28123771

  7. A parent-report Gender Identity Questionnaire for Children: A cross-national, cross-clinic comparative analysis.

    PubMed

    Cohen-Kettenis, Peggy T; Wallien, Madeleine; Johnson, Laurel L; Owen-Anderson, Allison F H; Bradley, Susan J; Zucker, Kenneth J

    2006-07-01

    A one-factor, 14-item parent-report Gender Identity Questionnaire for Children (GIQC) was developed in a sample of 325 clinic-referred children with gender identity problems and 504 controls from Toronto, Canada (Johnson et al., 2004). In this study, we report a cross-national, cross-clinic comparative analysis of the GIQC on gender-referred children (N = 338) from Toronto and gender-referred children (N = 175) from Utrecht, The Netherlands. Across clinics, the results showed both similarities and differences. Gender-referred boys from Utrecht had a significantly higher total score (indicating more cross-gender behavior) than did gender-referred boys from Toronto, but there was no significant difference for girls. In the Toronto sample, the gender-referred girls had a significantly higher total score than the gender-referred boys, but there was no significant sex difference in the Utrecht sample. Across both clinics, gender-referred children who met the complete DSM criteria for gender identity disorder (GID) had a significantly higher cross-gender score than the gender-referred children who were subthreshold for GID (Cohen's d = 1.11). The results of this study provide the first empirical evidence of relative similarity in cross-gender behavior in a sample of gender-referred children from western Europe when compared to North American children. The results also provide some support for cross-clinic consistency in clinician-based diagnosis of GID.

  8. Patient-reported outcome measures in arthroplasty registries

    PubMed Central

    Bohm, Eric; Franklin, Patricia; Lyman, Stephen; Denissen, Geke; Dawson, Jill; Dunn, Jennifer; Eresian Chenok, Kate; Dunbar, Michael; Overgaard, Søren; Garellick, Göran; Lübbeke, Anne

    2016-01-01

    Abstract — The International Society of Arthroplasty Registries (ISAR) Patient-Reported Outcome Measures (PROMs) Working Group have evaluated and recommended best practices in the selection, administration, and interpretation of PROMs for hip and knee arthroplasty registries. The 2 generic PROMs in common use are the Short Form health surveys (SF-36 or SF-12) and EuroQol 5-dimension (EQ-5D). The Working Group recommends that registries should choose specific PROMs that have been appropriately developed with good measurement properties for arthroplasty patients. The Working Group recommend the use of a 1-item pain question (“During the past 4 weeks, how would you describe the pain you usually have in your [right/left] [hip/knee]?”; response: none, very mild, mild, moderate, or severe) and a single-item satisfaction outcome (“How satisfied are you with your [right/left] [hip/knee] replacement?”; response: very unsatisfied, dissatisfied, neutral, satisfied, or very satisfied). Survey logistics include patient instructions, paper- and electronic-based data collection, reminders for follow-up, centralized as opposed to hospital-based follow-up, sample size, patient- or joint-specific evaluation, collection intervals, frequency of response, missing values, and factors in establishing a PROMs registry program. The Working Group recommends including age, sex, diagnosis at joint, general health status preoperatively, and joint pain and function score in case-mix adjustment models. Interpretation and statistical analysis should consider the absolute level of pain, function, and general health status as well as improvement, missing data, approaches to analysis and case-mix adjustment, minimal clinically important difference, and minimal detectable change. The Working Group recommends data collection immediately before and 1 year after surgery, a threshold of 60% for acceptable frequency of response, documentation of non-responders, and documentation of incomplete or

  9. Patient-Reported Outcomes After Multiligament Knee Injury

    PubMed Central

    Hanley, Jessica M.; Anthony, Christopher A.; DeMik, David; Glass, Natalie; Amendola, Annunziato; Wolf, Brian R.; Bollier, Matthew

    2017-01-01

    Background: Management of the medial collateral ligament (MCL) in the setting of a multiligamentous knee injury (MLKI) represents an area of great controversy. Purpose: Our study was designed to compare long-term patient-reported outcomes (PROs) after MCL repair versus reconstruction in the setting of a multiligamentous injury of the knee. Study Design: Cohort study; Level of evidence, 3. Methods: At a single institution, 68 patients were identified over a 10-year period as having MCL intervention in the setting of MLKI. Of these patients, 34 (50%) were successfully contacted via telephone to collect Lysholm and International Knee Documentation Committee (IKDC) scores. A retrospective chart review of these subjects was also conducted to identify patient and surgical factors affecting PROs. Results: At a mean 6-year follow-up (range, 2-11 years), the mean Lysholm score was 77.4 ± 23.1 and mean IKDC score was 72.6 ± 23.6. Univariate analyses identified time to surgery (P = .005) and MCL reconstruction (P = .001) as risk factors for Lysholm score ≤75. Univariate analyses identified patient age (P = .049), time to surgery (P = .018), and MCL reconstruction (P = .004) as risk factors for IKDC score ≤75. On subsequent multivariate analysis, MCL reconstruction was found to be a predictor of Lysholm or IKDC score of ≤75. Conclusion: Patients undergoing MCL repair in the setting of MLKI generally had higher PROs than those undergoing reconstructions at a mean 6 years of follow-up. Further work is needed to elucidate patient and surgical factors that may influence subjective outcomes after multiligament knee injuries. PMID:28357408

  10. Development and initial validation of a traditional Chinese medicine symptom-specific outcome measure: a Zheng-related atopic dermatitis symptom questionnaire (ZRADSQ)

    PubMed Central

    2013-01-01

    Background Zheng represents pattern differentiation in Traditional Chinese Medicine (TCM), as the basic unit and a key concept in TCM therapeutic theory, is based on the physiology and pathology of TCM. None of the outcome measurements of atopic dermatitis (AD) are Zheng-specific. The effectiveness of TCM is likely to be underestimated without a Zheng-related symptom-specific instrument. The aim of this study was to develop an instrument for measuring the Zheng-related symptom-specific status of patients with AD. Methods We followed standard methodology to develop the instrument, including item generation and selection, item reduction and presentation, and pretesting, and recruited 188 patients with AD involved in a six-center randomized-controlled trial (ChiCTR-TRC-08000156) to validate the questionnaire. We conducted construct validity, reliability, and responsiveness analysis. The standardized effect size (SES) and standardized response mean (SRM) were used to calculate the responsiveness of additional items and the total score for the rating items. Results ZRADSQ has 15 items, with 12 rating items and 3 additional items. The 12 rating items fall within three domains: AD symptoms (n = 6 items); Heat (n = 4 items) and Mood (n = 2 items). Confirmatory factor analysis provided good support for a three-factor model (d.f. = 51, x2=97.11, RMSEA = 0.07, CFI = 0.96), and the Pearson’s correlation coefficient between ZRADSQ and Severity Scoring of Atopic Dermatitis (SCORAD) was 0.40 (P < 0.001). The reliability was also good, with a Cronbach’s alpha value for ZRADSQ of 0.84, a split-half coefficient of 0.75, and a test-retest reliability coefficient of 0.98. The standardized effect size and standardized response mean were close to or larger than 1, which indicated moderate to good responsiveness. Conclusions The ZRADSQ demonstrates promising reliability, validity, and responsiveness. It can be used to determine whether Zheng-specific or

  11. Upper Airway Stimulation for Obstructive Sleep Apnea: Patient-Reported Outcomes after 48 Months of Follow-up.

    PubMed

    Gillespie, M Boyd; Soose, Ryan J; Woodson, B Tucker; Strohl, Kingman P; Maurer, Joachim T; de Vries, Nico; Steward, David L; Baskin, Jonathan Z; Badr, M Safwan; Lin, Ho-Sheng; Padhya, Tapan A; Mickelson, Sam; Anderson, W McDowell; Vanderveken, Olivier M; Strollo, Patrick J

    2017-04-01

    Objective To assess patient-based outcomes of participants in a large cohort study-the STAR trial (Stimulation Therapy for Apnea Reduction)-48 months after implantation with an upper airway stimulation system for moderate to severe obstructive sleep apnea. Study Design A multicenter prospective cohort study. Setting Industry-supported multicenter academic and clinical setting. Subjects Participants (n = 91) at 48 months from a cohort of 126 implanted participants. Methods A total of 126 participants received an implanted upper airway stimulation system in a prospective phase III trial. Patient-reported outcomes at 48 months, including Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), and snoring level, were compared with preimplantation baseline. Results A total of 91 subjects completed the 48-month visit. Daytime sleepiness as measured by ESS was significantly reduced ( P = .01), and sleep-related quality of life as measured by FOSQ significantly improved ( P = .01) when compared with baseline. Soft to no snoring was reported by 85% of bed partners. Two patients required additional surgery without complication for lead malfunction. Conclusion Upper airway stimulation maintained a sustained benefit on patient-reported outcomes (ESS, FOSQ, snoring) at 48 months in select patients with moderate to severe obstructive sleep apnea.

  12. Patient reported outcomes in head and neck cancer: selecting instruments for quality of life integration in clinical protocols

    PubMed Central

    2010-01-01

    Background Health Related Quality of Life has been used in medical research for more than twenty years, being progressively accepted during the last decade as an important patient reported outcome. Considering the multidimensional approach involved in Health Related Quality of Life assessment, instrument applicability and cultural adaptation must be tested for each population. In order to select the most appropriate instrument for Head and Neck cancer patients, two major Health Related Quality of Life specific questionnaires for Head and Neck cancer patients were compared. Conceptual differences, psychometric characteristics, scores, reliability, construct validity and sensitivity to symptomatology, tumour location, tumour size were analyzed. Methods 102 consecutive Head and Neck cancer patients completed two different Health Related Quality of Life questionnaires: EORTC QLQ-C30 and its specific head and neck module QLQ-H&N35 and the Functional Assessment of Cancer Therapy Scales (FACT-H&N). Patients completed the questionnaires, immediately before consultation as a part of the routine evaluation. Results A greater variability was always found in the EORTC QLC-C30 questionnaire's scores for all comparable domains. Both instruments revealed a good internal consistency and demonstrated to be good tools to distinguish symptomatic patients. The EORTC questionnaires still demonstrated sensitivity to distinguish T3 and T4 staging. Conceptual differences and the psychometric characteristics are discussed. Our results suggest that these two instruments assess different aspects of Health Related Quality of Life - the questionnaires should be used separately and chosen according to the study objectives and methodology. Conclusions This study emphases the importance in selecting the appropriate tool as a critical success factor in implementing routine Health Related Quality of Life assessment in clinical practice. This decision assumes particularly importance when utilization

  13. Self-Reported and FEMA Flood Exposure Assessment after Hurricane Sandy: Association with Mental Health Outcomes

    PubMed Central

    Liu, Bian; Schneider, Samantha; Schwartz, Rebecca; Taioli, Emanuela

    2017-01-01

    Hurricane Sandy caused extensive physical and economic damage; the long-term mental health consequences are unknown. Flooding is a central component of hurricane exposure, influencing mental health through multiple pathways that unfold over months after flooding recedes. Here we assess the concordance in self-reported and Federal Emergency Management (FEMA) flood exposure after Hurricane Sandy and determine the associations between flooding and anxiety, depression, and post-traumatic stress disorder (PTSD). Self-reported flood data and mental health symptoms were obtained through validated questionnaires from New York City and Long Island residents (N = 1231) following Sandy. Self-reported flood data was compared to FEMA data obtained from the FEMA Modeling Task Force Hurricane Sandy Impact Analysis. Multivariable logistic regressions were performed to determine the relationship between flooding exposure and mental health outcomes. There were significant discrepancies between self-reported and FEMA flood exposure data. Self-reported dichotomous flooding was positively associated with anxiety (ORadj: 1.5 [95% CI: 1.1–1.9]), depression (ORadj: 1.7 [1.3–2.2]), and PTSD (ORadj: 2.5 [1.8–3.4]), while self-reported continuous flooding was associated with depression (ORadj: 1.1 [1.01–1.12]) and PTSD (ORadj: 1.2 [1.1–1.2]). Models with FEMA dichotomous flooding (ORadj: 2.1 [1.5–2.8]) or FEMA continuous flooding (ORadj: 1.1 [1.1–1.2]) were only significantly associated with PTSD. Associations between mental health and flooding vary according to type of flood exposure measure utilized. Future hurricane preparedness and recovery efforts must integrate micro and macro-level flood exposures in order to accurately determine flood exposure risk during storms and realize the long-term importance of flooding on these three mental health symptoms. PMID:28129410

  14. Self-Reported and FEMA Flood Exposure Assessment after Hurricane Sandy: Association with Mental Health Outcomes.

    PubMed

    Lieberman-Cribbin, Wil; Liu, Bian; Schneider, Samantha; Schwartz, Rebecca; Taioli, Emanuela

    2017-01-01

    Hurricane Sandy caused extensive physical and economic damage; the long-term mental health consequences are unknown. Flooding is a central component of hurricane exposure, influencing mental health through multiple pathways that unfold over months after flooding recedes. Here we assess the concordance in self-reported and Federal Emergency Management (FEMA) flood exposure after Hurricane Sandy and determine the associations between flooding and anxiety, depression, and post-traumatic stress disorder (PTSD). Self-reported flood data and mental health symptoms were obtained through validated questionnaires from New York City and Long Island residents (N = 1231) following Sandy. Self-reported flood data was compared to FEMA data obtained from the FEMA Modeling Task Force Hurricane Sandy Impact Analysis. Multivariable logistic regressions were performed to determine the relationship between flooding exposure and mental health outcomes. There were significant discrepancies between self-reported and FEMA flood exposure data. Self-reported dichotomous flooding was positively associated with anxiety (ORadj: 1.5 [95% CI: 1.1-1.9]), depression (ORadj: 1.7 [1.3-2.2]), and PTSD (ORadj: 2.5 [1.8-3.4]), while self-reported continuous flooding was associated with depression (ORadj: 1.1 [1.01-1.12]) and PTSD (ORadj: 1.2 [1.1-1.2]). Models with FEMA dichotomous flooding (ORadj: 2.1 [1.5-2.8]) or FEMA continuous flooding (ORadj: 1.1 [1.1-1.2]) were only significantly associated with PTSD. Associations between mental health and flooding vary according to type of flood exposure measure utilized. Future hurricane preparedness and recovery efforts must integrate micro and macro-level flood exposures in order to accurately determine flood exposure risk during storms and realize the long-term importance of flooding on these three mental health symptoms.

  15. The relationship between interviewer-respondent race match and reporting of energy intake using food frequency questionnaires in the rural South United States

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The purpose of the observational study was to determine whether interviewer race influences food frequency questionnaire (FFQ) reporting accuracy in a Deep South, largely African American cohort. A secondary analysis was conducted to investigate the influence of interviewer race on energy reporting ...

  16. Quality and consistency of outcome reporting in clinical trials of immunosuppression in renal transplantation.

    PubMed

    Hussain, Samia; Knight, Simon R

    2016-11-01

    Interpretation, comparison, and combination of results of clinical trials are reliant on accurate and complete reporting of outcomes. This study aimed to assess the quality and variability in outcome reporting in immunosuppression trials following renal transplantation. All randomized controlled trials comparing immunosuppressive interventions in renal transplant recipients published over a 5-year period were included. Outcomes reported in these studies were extracted, along with data regarding completeness of reporting and whether a clear definition of the method used to measure the outcome was provided. A total of 4760 outcomes were identified from 182 studies. Overall, 90.3% outcomes were completely reported; the remainder had missing data that would preclude use in meta-analysis; 31.5% manuscripts did not define a primary endpoint. Efficacy outcomes were more likely to be clearly defined than safety outcomes (OR: 0.022, P<.001) or patient-reported outcome measures (PROMs) (OR: 0.014, P<.001). PROMs were reported in less than half of manuscripts, and only five reported quality-of-life data using a validated tool. There was significant variability in the way that common efficacy and safety outcomes were defined. Variability in the way that endpoints are selected and reported in trials in renal transplantation makes interpretation and comparison between studies difficult.

  17. Assessing patient reported outcome measures: A practical guide for gastroenterologists

    PubMed Central

    Hutchings, Hayley A; Williams, John G

    2014-01-01

    Gastrointestinal illnesses cause physical, emotional and social impact on patients. Patient reported outcome measures (PROMs) are increasingly used in clinical decision-making, clinical research and approval of new therapies. In the last decade, there has been a rapid increase in the number of PROMs in gastroenterology and, therefore, the choice between which of these PROMs to use can be difficult. Not all PROM instruments currently used in research and clinical practice in gastroenterology have gone through a rigorous development methodology. New drugs and therapies will not have access to the market if the PROMs used in their clinical trials are not validated according to the guidelines of the international agencies. Therefore, it is important to know the required properties of PROMs when choosing or evaluating a drug or a clinical intervention. This paper reviews the current literature on how to assess the validity and reliability of PROMs. It summarises the required properties into a practical guide for gastroenterologists to use in assessing an instrument for use in clinical practice or research. PMID:25452841

  18. Summary of Outcome Evaluation Report for Preparing Educational Training Consultants: Skills Training (PETC-1).

    ERIC Educational Resources Information Center

    George, Catherine; Green, David

    This report summarizes the technical report Outcome Evaluation Report for Preparing Educational Training Consultants: Skills Training (PETC-I) which presents the data collected about the three outcome studies of the PETC-I system. This information is primarily summative in nature and is designed to help those who may be considering the system as a…

  19. Two-year patient-reported outcomes following treatment of uveal melanoma.

    PubMed

    Hope-Stone, L; Brown, S L; Heimann, H; Damato, B; Salmon, P

    2016-12-01

    PurposeTreatment of uveal melanoma can impair patients' psychological well-being. We evaluated patient-reported outcome measures (PROMs) of anxiety, depression, and quality of life (QoL) over 2 years following treatment in a consecutive sample of uveal melanoma patients, compared observations to population normative values and examined whether outcomes differed according to patients' age, gender, and whether or not they were treated by enucleation or had a poor prognosis (presence of monosomy 3).DesignProspective longitudinal study.ParticipantsPatients (N=411) with uveal melanoma treated between 2008 and 2011.MethodsSelf-report questionnaire study. We compared mean PROMs scores obtained 6 months, 1 year, and 2 years after treatment to published population normative values using 2-sample t-tests, and tested the association of these scores with gender, age, treatment by enucleation, and monosomy 3 using mixed-model ANOVAs.ResultsOn QoL and depression, patients were similar to or better than normative values at all time points, but there was some evidence that females were more anxious than female normative values (Ps<0.001-<0.05). Younger patients (P<0.01) and female patients (P<0.01) were the most anxious overall. Enucleation was not associated with PROMs. Patients with monosomy 3 showed more depressed mood at all the three time points (P<0.05).ConclusionsPatients treated for uveal melanoma can expect, within 6 months of treatment, to have a QoL that is similar to that of the general population. Younger female patients and patients with monosomy 3 are more likely to be distressed, and clinicians will need to be alert to this.

  20. Patient-Reported Outcomes in Oncology Drug Labeling in the United States: A Framework for Navigating Early Challenges

    PubMed Central

    Shields, Alan L.; Hao, Yanni; Krohe, Meaghan; Yaworsky, Andrew; Mazar, Iyar; Foley, Catherine; Mehmed, Faisal; Globe, Denise

    2016-01-01

    Background Despite an increased use of patient-reported outcomes (PROs) in oncology clinical trials, integrating the patient perspective into drug approval decisions and documentation has been challenging. Objectives To review important regulatory and measurement terminology, and to provide oncology outcomes researchers and those involved with building oncology programs with tools to plan PRO data collection, particularly in relation to drug efficacy claims for drug labeling in the United States. Discussion When contemplating a PRO measurement strategy for oncology clinical trials, outcomes researchers are challenged in several ways. First, given multiple stakeholders, researchers must communicate with their scientific, commercial, and regulatory colleagues using often misunderstood terms, such as “label,” “claim,” “end point,” “outcome,” and “concept.” Second, because stakeholders do not always have access to data from early-stage clinical trials and do not contribute to the target drug's profile in early development, researchers are often unable to address the most important question in building a measurement strategy: What do we want to say about our drug? To overcome these challenges, researchers can systematically develop an end point model to facilitate communication among drug development stakeholders using a common language and to link the building blocks of a PRO measurement strategy, including claims, concepts, questionnaires, and end points. We developed a model that characterizes a disease by its proximal signs and/or symptoms and increasingly distal health outcomes to provide researchers potential measurement concepts that can be instrumental in selecting PRO questionnaires for use in studies. Conclusion PRO data collected in clinical trials should be used in drug development to evaluate the drug's efficacy; it is encouraging that US regulators are willing to work with drug sponsors to overcome the challenges associated with the

  1. Adverse Outcome Pathways: From Research to Regulation - Scientific Workshop Report

    EPA Science Inventory

    An adverse outcome pathway (AOP) organizes existing knowledge on chemical mode of action, starting with a molecular initiating event such as receptor binding, continuing through key events, and ending with an adverse outcome such as reproductive impairment. AOPs can help identify...

  2. Motives for sports participation as predictions of self-reported outcomes after anterior cruciate ligament injury of the knee.

    PubMed

    Roessler, K K; Andersen, T E; Lohmander, S; Roos, E M

    2015-06-01

    Aim of the study was to access how individual's motives for participation in sports impact on self-reported outcomes 2 years after an anterior cruciate ligament injury. Based on a longitudinal cohort study, this secondary analysis present data from the Knee Anterior Cruciate Ligament, Nonsurgical versus Surgical Treatment (KANON) study, a randomized controlled trial. At baseline, 121 patients recorded in an initial questionnaire that their motives for sports participation fell into four categories: achievement, health, social integration, or fun and well-being. These four categories were used as variables in the analyses. All 121 subjects completed the 2-year follow-up. The largest improvement was seen in the Knee Injury and Osteoarthritis Outcome Score (KOOS) subscale sports and recreation function, with an effect size of 2.43. KOOS sports and recreation function was also the subscale score best predicted by the motives for sports participation. Baseline motives achievement and fun and well-being predicted worse levels of pain and function 2 years after the injury, even after adjusting for age, gender, treatment and baseline scores. Psychological aspects, such as motives for participation in sport, can be factors in predicting of patient-reported outcomes 2 years after injury. Evaluating motives for sports participation may help predict the outcome 2 years after ACL injury.

  3. Monitoring outcomes of arthritis and longitudinal data collection in routine care using a patient questionnaire that incorporates a clinical note on one piece of paper.

    PubMed

    Yazici, Yusuf

    2007-08-01

    Patient questionnaires are the quantitative tools available to rheumatologists to monitor their patients' health status and responses to therapy. The Health Assessment Questionnaire (HAQ) and its derivatives have been shown to be the most significant predictors of functional and work disability, costs, joint replacement surgery, and mortality; generally at higher levels of significance than joint counts, radiographs, and laboratory tests. Every encounter of a patient with a rheumatologist provides an opportunity to collect data. Yet patient questionnaires, which can be used in all rheumatic diseases, including osteoarthritis, systemic lupus erythematosus, fibromyalgia, scleroderma, and ankylosing spondylitis, are not included in routine care by most rheumatologists. Questionnaires can be adapted to include a simple subjective-objective-assessment-plan (SOAP) clinical encounter note that helps with data entry and also provides all the necessary information for clinical decision making in one sheet of paper. Data that are feasible to collect in clinical care provide the optimal approach to assessing quantitatively how patients are doing. If data are not collected and recorded, that opportunity, on that day, is lost forever. Rheumatologists would find it valuable to adapt questionnaires to the care they provide for all their patients, to document and improve the care they provide, and add quantitative data to standard clinical care.

  4. Interpreting patient-reported outcomes from clinical trials in COPD: a discussion.

    PubMed

    Jones, Paul W; Rennard, Stephen; Tabberer, Maggie; Riley, John H; Vahdati-Bolouri, Mitra; Barnes, Neil C

    2016-01-01

    One of the challenges faced by the practising physician is the interpretation of patient-reported outcomes (PROs) in clinical trials and the relevance of such data to their patients. This is especially true when caring for patients with progressive diseases such as COPD. In an attempt to incorporate the patient perspective, many clinical trials now include assessments of PROs. These are formalized methods of capturing patient-centered information. Given the importance of PROs in evaluating the potential utility of an intervention for a patient with COPD, it is important that physicians are able to critically interpret (and critique) the results derived from them. Therefore, in this paper, a series of questions is posed for the practising physician to consider when reviewing the treatment effectiveness as assessed by PROs. The focus is on the St George's Respiratory Questionnaire for worked examples, but the principles apply equally to other symptom-based questionnaires. A number of different ways of presenting PRO data are discussed, including the concept of the minimum clinically important difference, whether there is a ceiling effect to PRO results, and the strengths and weaknesses of responder analyses. Using a worked example, the value of including a placebo arm in a study is illustrated, and the influence of the study on PRO results is considered, in terms of the design, patient withdrawal, and the selection of the study population. For the practising clinician, the most important consideration is the importance of individualization of treatment (and of treatment goals). To inform such treatment, clinicians need to critically review PRO data. The hope is that the questions posed here will help to build a framework for this critical review.

  5. Interpreting patient-reported outcomes from clinical trials in COPD: a discussion

    PubMed Central

    Jones, Paul W; Rennard, Stephen; Tabberer, Maggie; Riley, John H; Vahdati-Bolouri, Mitra; Barnes, Neil C

    2016-01-01

    One of the challenges faced by the practising physician is the interpretation of patient-reported outcomes (PROs) in clinical trials and the relevance of such data to their patients. This is especially true when caring for patients with progressive diseases such as COPD. In an attempt to incorporate the patient perspective, many clinical trials now include assessments of PROs. These are formalized methods of capturing patient-centered information. Given the importance of PROs in evaluating the potential utility of an intervention for a patient with COPD, it is important that physicians are able to critically interpret (and critique) the results derived from them. Therefore, in this paper, a series of questions is posed for the practising physician to consider when reviewing the treatment effectiveness as assessed by PROs. The focus is on the St George’s Respiratory Questionnaire for worked examples, but the principles apply equally to other symptom-based questionnaires. A number of different ways of presenting PRO data are discussed, including the concept of the minimum clinically important difference, whether there is a ceiling effect to PRO results, and the strengths and weaknesses of responder analyses. Using a worked example, the value of including a placebo arm in a study is illustrated, and the influence of the study on PRO results is considered, in terms of the design, patient withdrawal, and the selection of the study population. For the practising clinician, the most important consideration is the importance of individualization of treatment (and of treatment goals). To inform such treatment, clinicians need to critically review PRO data. The hope is that the questions posed here will help to build a framework for this critical review. PMID:27994447

  6. Australian Enterococcal Sepsis Outcome Programme annual report, 2013.

    PubMed

    Coombs, Geoffrey W; Pearson, Julie C; Daly, Denise A; Le, Tam T; Robinson, James O; Gottlieb, Thomas; Howden, Benjamin P; Johnson, Paul D R; Bennett, Catherine M; Stinear, Timothy P; Turnidge, John D

    2014-12-31

    From 1 January to 31 December 2013, 26 institutions around Australia participated in the Australian Enterococcal Sepsis Outcome Programme (AESOP). The aim of AESOP 2013 was to determine the proportion of enterococcal bacteraemia isolates in Australia that are antimicrobial resistant, and to characterise the molecular epidemiology of the Enterococcus faecium isolates. Of the 826 unique episodes of bacteraemia investigated, 94.6% were caused by either E. faecalis (56.1%) or E. faecium (38.5%). Ampicillin resistance was not detected in E. faecalis but was detected in over 90% of E. faecium. Vancomycin non-susceptibility was reported in 0.2% and 40.9% of E. faecalis and E. faecium respectively and was predominately due to the acquisition of the vanB operon. Overall, 41.6% of E. faecium harboured vanA or vanB genes. The percentage of E. faecium bacteraemia isolates resistant to vancomycin in Australia is significantly higher than that seen in most European countries. E. faecium isolates consisted of 81 pulsed-field gel electrophoresis pulsotypes of which 72.3% were classified into 14 major pulsotypes containing five or more isolates. Multilocus sequence typing grouped the 14 major pulsotypes into clonal cluster 17, a major hospital-adapted polyclonal E. faecium cluster. Of the 2 predominant sequence types, ST203 (80 isolates) was identified across Australia and ST555 (40 isolates) was isolated primarily in the western and central regions (Northern Territory, South Australia and Western Australia) respectively. In conclusion, the AESOP 2013 has shown enterococcal bacteraemias in Australia are frequently caused by polyclonal ampicillin-resistant high-level gentamicin resistant vanB E. faecium, which have limited treatment options.

  7. Poor Outcomes in Hepatic Amyloidosis: A Report of 2 Cases

    PubMed Central

    Kertowidjojo, Elizabeth; Zhang, Yue; Patel, Pruthvi

    2016-01-01

    Hepatic amyloidosis is a rare disease entity that results from insoluble amyloid protein deposition in the liver. The disease often presents with vague, nonspecific clinical features. Currently, there is little literature describing treatment outcomes for biopsy-proven hepatic amyloidosis and current treatment guidelines recommend that patients enroll in a clinical trial due to insufficient evidence to suggest an optimal treatment regimen. Here, we present two cases of hepatic amyloidosis at an academic medical center and describe their presentation, treatment, and outcomes. These cases highlight the poor outcomes and difficult management of hepatic amyloidosis. Further understanding and investigation of this rare disease are warranted. PMID:27774327

  8. Self-Reported Cognitive Outcomes in Patients With Brain Metastases Before and After Radiation Therapy

    SciTech Connect

    Cole, Ansa Maer; Scherwath, Angela; Ernst, Gundula; Lanfermann, Heinrich; Bremer, Michael; Steinmann, Diana

    2013-11-15

    Purpose: Patients with brain metastases may experience treatment-related cognitive deficits. In this study, we prospectively assessed the self-reported cognitive abilities of patients with brain metastases from any solid primary cancer before and after irradiation of the brain. Methods and Materials: The treatment group (TG) consisted of adult patients (n=50) with brain metastases who received whole or partial irradiation of the brain without having received prior radiation therapy (RT). The control group (CG) consisted of breast cancer patients (n=27) without cranial involvement who were treated with adjuvant RT. Patients were recruited between May 2008 and December 2010. Self-reported cognitive abilities were acquired before RT and 6 weeks, 3 months, and 6 months after irradiation. The information regarding the neurocognitive status was collected by use of the German questionnaires for self-perceived deficits in attention (FEDA) and subjectively experienced everyday memory performance (FEAG). Results: The baseline data showed a high proportion of self-perceived neurocognitive deficits in both groups. A comparison between the TG and the CG regarding the course of self-reported outcomes after RT showed significant between-group differences for the FEDA scales 2 and 3: fatigue and retardation of daily living activities (P=.002) and decrease in motivation (P=.032) with an increase of attention deficits in the TG, but not in the CG. There was a trend towards significance in FEDA scale 1: distractibility and retardation of mental processes (P=.059) between the TG and the CG. The FEAG assessment presented no significant differences. An additional subgroup analysis within the TG was carried out. FEDA scale 3 showed significant differences in the time-related progress between patients with whole-brain RT and those receiving hypofractionated stereotactic RT (P=.025), with less decrease in motivation in the latter group. Conclusion: Self-reported attention declined in

  9. Pixel or Paper? Validation of a Mobile Technology for Collecting Patient-Reported Outcomes in Rheumatoid Arthritis

    PubMed Central

    Epis, Oscar Massimiliano; Casu, Cinzia; Belloli, Laura; Schito, Emanuela; Filippini, Davide; Muscarà, Marina; Gentile, Maria Giovanna; Venerelli, Chiara; Sonnati, Massimo; Schiavetti, Irene; Bruschi, Eleonora

    2016-01-01

    Background In the management of chronic disease, new models for telemonitoring of patients combined with the choice of electronic patient-reported outcomes (ePRO) are being encouraged, with a clear improvement of both patients’ and parents’ quality of life. An Italian study demonstrated that ePRO were welcome in patients with rheumatoid arthritis (RA), with excellent matching data. Objective The aim of this study is to evaluate the level of agreement between electronic and paper-and-pencil questionnaire responses. Methods This is an observational prospective study. Patients were randomly assigned to first complete the questionnaire by paper and pencil and then by tablet or in the opposite order. The questionnaire consisted of 3 independent self-assessment visual rating scales (Visual Analog Scale, Global Health score, Patient Global Assessment of Disease Activity) commonly used in different adult patients, including those with rheumatic diseases. Results A total of 185 consecutive RA patients were admitted to hospital and were enrolled and completed the questionnaire both on paper and on electronic versions. For all the evaluated items, the intrarater degree of agreement between 2 approaches was found to be excellent (intraclass correlation coefficient>0.75, P<.001). Conclusions An electronic questionnaire is uploaded in a dedicated Web-based tool that could implement a telemonitoring system aimed at improving the follow-up of RA patients. High intrarater reliability between paper and electronic methods of data collection encourage the use of a new digital app with consequent benefit for the overall health care system. PMID:27852561

  10. Quality Assurance and Learning Outcomes. ENQA Workshop Report 17

    ERIC Educational Resources Information Center

    Adamson, Lena; Becerro, Maria; Cullen, Peter; Gonzalez-Vega, Laureano; Sobrino, Juan Jose; Ryan, Norma

    2010-01-01

    Learning outcomes are described as written statements of what a learner is expected to know, understand and/or be able to do at the end of a period of learning. At the beginning of the 90s, a EU pilot project on ECTS showed that study programmes were much easier to compare if they were described in terms of outcomes, instead of inputs. The…

  11. Improving energy audit process and report outcomes through planning initiatives

    NASA Astrophysics Data System (ADS)

    Sprau Coulter, Tabitha L.

    Energy audits and energy models are an important aspect of the retrofit design process, as they provide project teams with an opportunity to evaluate a facilities current building systems' and energy performance. The information collected during an energy audit is typically used to develop an energy model and an energy audit report that are both used to assist in making decisions about the design and implementation of energy conservation measures in a facility. The current lack of energy auditing standards results in a high degree of variability in energy audit outcomes depending on the individual performing the audit. The research presented is based on the conviction that performing an energy audit and producing a value adding energy model for retrofit buildings can benefit from a revised approach. The research was divided into four phases, with the initial three phases consisting of: 1.) process mapping activity - aimed at reducing variability in the energy auditing and energy modeling process. 2.) survey analysis -- To examine the misalignment between how industry members use the top energy modeling tools compared to their intended use as defined by software representatives. 3.) sensitivity analysis -- analysis of the affect key energy modeling inputs are having on energy modeling analysis results. The initial three phases helped define the need for an improved energy audit approach that better aligns data collection with facility owners' needs and priorities. The initial three phases also assisted in the development of a multi-criteria decision support tool that incorporates a House of Quality approach to guide a pre-audit planning activity. For the fourth and final research phase explored the impacts and evaluation methods of a pre-audit planning activity using two comparative energy audits as case studies. In each case, an energy audit professionals was asked to complete an audit using their traditional methods along with an audit which involved them first

  12. The Strengths and Difficulties Questionnaire as a Predictor of Parent-Reported Diagnosis of Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder

    PubMed Central

    Russell, Ginny; Rodgers, Lauren R.; Ford, Tamsin

    2013-01-01

    The Strengths and Difficulties Questionnaire (SDQ) is widely used as an international standardised instrument measuring child behaviour. The primary aim of our study was to examine whether behavioral symptoms measured by SDQ were elevated among children with autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) relative to the rest of the population, and to examine the predictive value of the SDQ for outcome of parent-reported clinical diagnosis of ASD/ADHD. A secondary aim was to examine the extent of overlap in symptoms between children diagnosed with these two disorders, as measured by the SDQ subscales. A cross-sectional secondary analysis of data from the Millennium Birth Cohort (n = 19,519), was conducted. Data were weighted to be representative of the UK population as a whole. ADHD or ASD identified by a medical doctor or health professional were reported by parents in 2008 and this was the case definition of diagnosis; (ADHD n = 173, ASD n = 209, excluding twins and triplets). Study children's ages ranged from 6.3–8.2 years; (mean 7.2 years). Logistic regression was used to examine the association between the parent-reported clinical diagnosis of ASD/ADHD and teacher and parent-reported SDQ subscales. All SDQ subscales were strongly associated with both ASD and ADHD. There was substantial co-occurrence of behavioral difficulties between children diagnosed with ASD and those diagnosed with ADHD. After adjustment for other subscales, the final model for ADHD, contained hyperactivity/inattention and impact symptoms only and had a sensitivity of 91% and specificity of 90%; (AUC) = 0.94 (95% CI, 0.90–0.97). The final model for ASD was composed of all subscales except the ‘peer problems’ scales, indicating of the complexity of behavioural difficulties that may accompany ASD. A threshold of 0.03 produced model sensitivity and specificity of 79% and 93% respectively; AUC = 0.90 (95% CI, 0.86–0.95). The

  13. Validating English- and Spanish-language patient-reported outcome measures in underserved patients with rheumatic disease

    PubMed Central

    2011-01-01

    Introduction Rheumatic diseases are among the most common and debilitating health problems in the United States. These diseases are chronic, can result in severe decrements of physical and psychosocial functioning and affect patients' overall quality of life. A consensus regarding the best patient outcomes to be measured in randomized, controlled trials and prospective natural history studies is essential to provide best estimates of efficacy and safety of interventions across diverse patient populations. Methods Face-to-face English- and Spanish-language cognitive interviews were conducted among urban Hispanic and African American patients with rheumatic disease to develop a questionnaire booklet. Six measures validating patient-reported outcomes were included: the Arthritis Self-Efficacy Scale, the Stanford Health Assessment Questionnaire Disability Index, the Wong-Baker Faces Pain Scale, the Short Acculturation Scale, the Center for Epidemiologic Studies Depression Scale and the Inventory of Complementary and Alternative Medicine Practices. A sample of patients (n = 15) attending the National Institute of Arthritis and Musculoskeletal and Skin Diseases Community Health Center participated in the initial interviews. Revised measures were further tested for reliability in a separate sample of patients (n = 109) upon enrollment at the health center. Results Cognitive interviews provided feedback for questionnaire modifications and methods to enhance content validity and data quality, including discarding redundant questions, providing visual aids and concrete examples when appropriate and increasing the use of racially and ethnically concordant interviewers. The cognitive interviews further elucidated that some contextual assumptions and language usage in the original questionnaires may not have taken each respondent's environmental and sociocultural context into consideration. Internal reliability for previously tested measures remained high (Cronbach's α = 0

  14. Loss to follow-up after total hip replacement: a source of bias in patient reported outcome measures and registry datasets?

    PubMed

    Imam, Mohamed A; Barke, Samuel; Stafford, Giles H; Parkin, David; Field, Richard E

    2014-01-01

    Patient reported outcome measures (PROMs) are used to gauge clinical performance. The PROMs outcome programme at our centre achieves a preoperative data capture rate of 99%. This falls to 90.6%, 89%, 83% and 79% at the six-week, six-month, one-year and two-year time points, respectively. The study aims were to determine factors associated with patients who did not respond to outcome questionnaires following total hip replacement (THR), and the potential implications this may have when assessing patients following THRs. During the first year of the PROMs programme, 1,322 patients underwent unilateral primary THR at our institution. Of these, 1,311 completed preoperative questionnaires. Thirty-eight patients (2.9%) died within two years of surgery and have been excluded. For the remaining 1,273 patients, we identified those who did not return postoperative questionnaires at each of our review time points. Younger age, lower baseline EQ5D and Oxford Hip scores (OHS) were significantly associated with non-response (p<0.001). Patients with lower satisfaction scores, OHS and EQ5D scores, were less likely to respond to subsequent questionnaires. A significant association between non-response and deprivation (p<0.001) was demonstrated. Our findings suggest that the more satisfied patients are over-represented and our reported outcome results are better than they would have been if all patients had responded. This phenomenon may apply to studies where those categorised as "lost to follow-up" represent a subset of patients who have disengaged due to poor outcome or satisfaction.

  15. Systematic Review of Outcome Measures Reported in Clinical Canine Osteoarthritis Research

    PubMed Central

    Asher, Lucy; Dean, Rachel S.

    2016-01-01

    Objective To record and categorize the outcome measures used in dogs with naturally occurring osteoarthritis (OA) by systematically reviewing the peer reviewed publications on OA in dogs. Study Design Systematic literature review. Study Population Peer reviewed literature on canine OA. Methods A computer‐based bibliographic search was performed on PubMed and CAB Abstracts in August 2013 to find peer reviewed publications relevant to canine OA. Inclusion and exclusion criteria were applied. The outcome measures reported within each publication were recorded and categorized for comparison. Adequately described outcome measures were assessed for uniqueness and evidence of prior validation. Results Of 3,697 publications identified and screened, 117 were deemed eligible for inclusion. Within eligible publications, outcome measures were used 618 times (median of 4 outcome measures per publication). Outcomes measured were divided into 5 groups containing 65 categories. The most frequently assessed outcomes were lameness assessment with no stated gait/mixed gaits (66 outcomes), radiography (58), and lameness single gait/lateral motion (55). Of 618 outcome measures reported, 491 were assessed for uniqueness and 348 (71%) were unique to a single publication. Ten outcome measures were reported to have been validated. Conclusion Many outcome measures have been used to assess canine OA. There is no consensus on which are the most useful outcomes or by which method they should be assessed. There is a pressing need for agreement on outcomes reporting in canine OA and for validation of outcome measures used for these assessments. Until consensus is reached, we recommend at least one validated outcome measure be used in every clinical study. PMID:27120270

  16. Self-Report Data in Cross-Cultural Research: Issues of Construct Validity in Questionnaires for Quantitative Research in Educational Leadership

    ERIC Educational Resources Information Center

    Thomas, Andrew

    2007-01-01

    This paper examines issues arising from the use of self-report questionnaires in cross-cultural contexts. The research draws from the extensive literature on cross-cultural leadership in business organizational culture as well as from educational cross-cultural contexts. It examines claims, drawn from business and educational contexts, that many…

  17. Subjective Mental Health, Peer Relations, Family, and School Environment in Adolescents with Intellectual Developmental Disorder: A First Report of a New Questionnaire Administered on Tablet PCs

    ERIC Educational Resources Information Center

    Boström, Petra; Johnels, Jakob Åsberg; Thorson, Maria; Broberg, Malin

    2016-01-01

    Few studies have explored the subjective mental health of adolescents with intellectual disabilities, while proxy ratings indicate an overrepresentation of mental health problems. The present study reports on the design and an initial empirical evaluation of the Well-being in Special Education Questionnaire (WellSEQ). Questions, response scales,…

  18. Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force.

    PubMed

    Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald; Marquis, Patrick; Vamvakas, Spiros; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan; Burke, Laurie B

    2015-09-01

    An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient's health status. Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition. Most efficacy endpoints are based on specified clinical assessments of patients. When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs). COAs include any assessment that may be influenced by human choices, judgment, or motivation. COAs must be well-defined and possess adequate measurement properties to demonstrate (directly or indirectly) the benefits of a treatment. In contrast, a biomarker assessment is one that is subject to little, if any, patient motivational or rater judgmental influence. This is the first of two reports by the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles. The foundation provided in this report includes what it means to demonstrate a beneficial effect, how assessments of patients relate to the objective of showing a treatment's benefit, and how these assessments are used in clinical trial endpoints. In addition, this report describes intrinsic attributes of patient assessments and clinical trial factors that can affect the properties of the measurements. These factors should be considered when developing or refining assessments. These considerations will aid investigators designing trials in their choice of using an existing assessment or developing a new outcome assessment. Although the focus of this report is on the development of a new COA to define endpoints in a clinical trial, these principles may be applied more generally. A critical element in appraising or developing a COA is to

  19. Guillain-Barré Syndrome with Fatal Outcome during HIV-1-Seroconversion: A Case Report

    PubMed Central

    Pontali, Emanuele; Feasi, Marcello; Crisalli, Maria Paola; Cassola, Giovanni

    2011-01-01

    Guillain-Barré syndrome (GBS) is an acute or subacute peripheral polyneuropathy characterized by symmetrical muscle weakness. Its occurrence has been reported during acute HIV seroconversion since 1985. Among HIV-infected subjects, GBS has generally a favourable outcome. We report a case of GBS with fatal outcome during HIV seroconversion. PMID:22567484

  20. Clinical Trial Registries Are of Minimal Use for Identifying Selective Outcome and Analysis Reporting

    ERIC Educational Resources Information Center

    Norris, Susan L.; Holmer, Haley K.; Fu, Rongwei; Ogden, Lauren A.; Viswanathan, Meera S.; Abou-Setta, Ahmed M.

    2014-01-01

    Objective: This study aimed to examine selective outcome reporting (SOR) and selective analysis reporting (SAR) in randomized controlled trials (RCTs) and to explore the usefulness of trial registries for identifying SOR and SAR. Study Design and Setting: We selected one "index outcome" for each of three comparative effectiveness reviews…

  1. How To Prepare and Present Effective Outcome Reports for External Payers and Regulators.

    ERIC Educational Resources Information Center

    Thompson, Ronald W.; Way, Mona L.

    2000-01-01

    This article describes practical methods for agencies to move from a process to an outcomes focus when preparing and presenting reports to payers and regulators. Essential components of an outcomes system are outlined, and methods for preparing and presenting reports are drawn from experiences at Father Flanagan's Boy's Home. (Contains…

  2. Australian Staphylococcus aureus Sepsis Outcome Programme annual report, 2013.

    PubMed

    Coombs, Geoffrey W; Nimmo, Graeme R; Daly, Denise A; Le, Tam T; Pearson, Julie C; Tan, Hui-Leen; Robinson, James O; Collignon, Peter J; McLaws, Mary-Louise; Turnidge, John D

    2014-12-31

    From 1 January to 31 December 2013, around Australia 26 institutions around Australia participated in the Australian Staphylococcal Sepsis Outcome Programme (ASSOP). The aim of ASSOP 2013 was to determine the proportion of Staphylococcus aureus bacteraemia (SAB) isolates in Australia that are antimicrobial resistant, (with particular emphasis on susceptibility to methicillin) and to characterise the molecular epidemiology of the isolates. Overall 19.1% of the 2,010 SAB episodes were methicillin resistant, which is significantly higher than that reported in most European countries. Although the SAB 30-day all cause mortality appears to be decreasing in Australia, methicillin-resistant SAB associated mortality remains high (20.1%) and was significantly higher than methicillin-sensitive SAB associated mortality (13%) (P< 0.0001). With the exception of the ß-lactams and erythromycin, antimicrobial resistance in methicillin sensitive S. aureus remains rare. However, in addition to the ß-lactams, approximately 50% of methicillin-resistant S. aureus (MRSA) were resistant to erythromycin and ciprofloxacin and approximately 20% were resistant to co-trimoxazole, tetracycline and gentamicin. Linezolid, daptomycin and teicoplanin resistance was detected in a small number of S. aureus isolates. Resistance to vancomycin was not detected. Resistance was largely attributable to 2 healthcare associated MRSA clones; ST22-IV [2B] (EMRSA-15) and ST239-III [3A] (Aus-2/3 EMRSA). ST22-IV [2B] (EMRSA-15) has now become the predominant healthcare associated clone in Australia. Approximately 60% of methicillin-resistant SAB were due to community associated clones. Although polyclonal, almost 50% of community associated clones were characterised as ST93-IV [2B] (Queensland CA-MRSA) and ST1-IV [2B] (WA1). CA-MRSA, in particular the ST45-V [5C2&5] (WA84) clone, has acquired multiple antimicrobial resistance determinants including ciprofloxacin, erythromycin, clindamycin, gentamicin and

  3. Variability of outcome reporting in Hirschsprung’s Disease and gastroschisis: a systematic review

    PubMed Central

    Allin, Benjamin Saul Raywood; Irvine, Amy; Patni, Nicholas; Knight, Marian

    2016-01-01

    Heterogeneity in outcome reporting limits identification of gold-standard treatments for Hirschsprung’s Disease(HD) and gastroschisis. This review aimed to identify which outcomes are currently investigated in HD and gastroschisis research so as to counter this heterogeneity through informing development of a core outcome set(COS). Two systematic reviews were conducted. Studies were eligible for inclusion if they compared surgical interventions for primary treatment of HD in review one, and gastroschisis in review two. Studies available only as abstracts were excluded from analysis of reporting transparency. Thirty-five HD studies were eligible for inclusion in the review, and 74 unique outcomes were investigated. The most commonly investigated was faecal incontinence (32 studies, 91%). Seven of the 28 assessed studies (25%) met all criteria for transparent outcome reporting. Thirty gastroschisis studies were eligible for inclusion in the review, and 62 unique outcomes were investigated. The most commonly investigated was length of stay (24 studies, 80%). None of the assessed studies met all criteria for transparent outcome reporting. This review demonstrates that heterogeneity in outcome reporting and a significant risk of reporting bias exist in HD and gastroschisis research. Development of a COS could counter these problems, and the outcome lists developed from this review could be used in that process. PMID:27941923

  4. Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance.

    PubMed

    Banerjee, Anjan K; Okun, Sally; Edwards, I Ralph; Wicks, Paul; Smith, Meredith Y; Mayall, Stephen J; Flamion, Bruno; Cleeland, Charles; Basch, Ethan

    2013-12-01

    The Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium was convened to improve safety reporting by better incorporating the perspective of the patient. PROSPER comprises industry, regulatory authority, academic, private sector and patient representatives who are interested in the area of patient-reported outcomes of adverse events (PRO-AEs). It has developed guidance on PRO-AE data, including the benefits of wider use and approaches for data capture and analysis. Patient-reported outcomes (PROs) encompass the full range of self-reporting, rather than only patient reports collected by clinicians using validated instruments. In recent years, PROs have become increasingly important across the spectrum of healthcare and life sciences. Patient-centred models of care are integrating shared decision making and PROs at the point of care; comparative effectiveness research seeks to include patients as participatory stakeholders; and industry is expanding its involvement with patients and patient groups as part of the drug development process and safety monitoring. Additionally, recent pharmacovigilance legislation from regulatory authorities in the EU and the USA calls for the inclusion of patient-reported information in benefit-risk assessment of pharmaceutical products. For patients, technological advancements have made it easier to be an active participant in one's healthcare. Simplified internet search capabilities, electronic and personal health records, digital mobile devices, and PRO-enabled patient online communities are just a few examples of tools that allow patients to gain increased knowledge about conditions, symptoms, treatment options and side effects. Despite these changes and increased attention on the perceived value of PROs, their full potential has yet to be realised in pharmacovigilance. Current safety reporting and risk assessment processes remain heavily dependent on healthcare professionals, though there are known limitations such

  5. Socioeconomic deprivation and age are barriers to the online collection of patient reported outcome measures in orthopaedic patients

    PubMed Central

    Jenkins, PJ; Sng, S; Brooksbank, K; Brooksbank, AJ

    2016-01-01

    Introduction Questionnaires are used commonly to assess functional outcome and satisfaction in surgical patients. Although these have in the past been administered through written forms, there is increasing interest in the use of new technology to improve the efficiency of collection. The aim of this study was to assess the availability of internet access for a group of orthopaedic patients and the acceptability of online survey completion. Methods A total of 497 patients attending orthopaedic outpatient clinics were surveyed to assess access to the internet and their preferred means for completing follow-up questionnaires. Results Overall, 358 patients (72%) reported having internet access. Lack of access was associated with socioeconomic deprivation and older age. Multivariable regression confirmed increased age and greater deprivation to be independently associated with lack of internet access. Out of the total group, 198 (40%) indicated a preference for assessment of outcomes via email and the internet. Conclusions Internet access was not universal among the patients in our orthopaedic clinic. Reliance on internet collection of PROMs may introduce bias by not including results from patients in older age groups and those from the more deprived socioeconomic groups. PMID:26688398

  6. Physical performance tests, self-reported outcomes, and accidental falls before and after total knee arthroplasty: an exploratory study.

    PubMed

    Swinkels, Annette; Allain, Theresa J

    2013-08-01

    This longitudinal, observational study explored the relationship between physical performance tests, self-reported outcomes, and accidental falling, before and after total knee arthroplasty (TKA). Thirty-seven patients were randomly selected from a larger study of falling before and after surgery conducted at a UK National Health Service Orthopaedic Unit. Physical performance tests were the Berg Balance Score (BBS), Timed Up and Go (TUG), and Hand Grip Strength (HGS). Self-reported outcomes incorporated the Western Ontario and McMaster's Osteoarthritis Index (WOMAC), Activities Balance Confidence Scale (ABC-UK), Geriatric Depression Scale (GDS), and accidental falls. Paired pre- and postoperative data were available on 22 patients. A total of 22.7% patients fell before and after TKA. Postoperative improvement in BBS and TUG was found in 41% and 50% of patients, respectively, HGS did not change. BBS showed a consistent moderate-to-strong association with other physical tests both before and after surgery; TUG (rs -0.76; rs -0.90), maximal HGS (r 0.49; r 0.48), and self-report measures; ABC-UK (r 0.52; r 0.74), WOMAC stiffness (r -0.53; r -0.48), and WOMAC function (r -0.56; r -0.45). Although self-report questionnaires are an efficient, cost-effective approach to outcome assessment in TKA, there is a growing case for inclusion of physical performance tests. The Berg Balance Score may be a useful addition to outcome assessment in patients with TKA.

  7. Learning Outcomes in Higher Education. A Development Project Report.

    ERIC Educational Resources Information Center

    Otter, Sue

    A project tested the feasibility of describing learning outcomes in adult/continuing education in ways that could be more clearly understood by three major groups of people--students, teachers, and employers of graduates--and how these could be assessed and accredited. Academic staff explored four different approaches to describing learning…

  8. Oregon Pre-Engineering Learning Outcomes Study: Final Report

    ERIC Educational Resources Information Center

    Conley, David T.; Langan, Holly; Veach, Darya; Farkas, Virginia

    2007-01-01

    The Oregon Pre-engineering Learning Outcomes Project was conducted by the Educational Policy Improvement Center (EPIC) with grant funding from the Engineering and Technology Industry Council (ETIC). The study sought to improve student preparation and success in pre-engineering programs through the development of the Oregon Pre-engineering Learning…

  9. Psychometric Evaluation of the Children's Behavior Questionnaire-Very Short Form in Preschool Children Using Parent and Teacher Report

    ERIC Educational Resources Information Center

    Allan, Nicholas P.; Lonigan, Christopher J.; Wilson, Shauna B.

    2013-01-01

    Temperament is a developmentally important construct, hierarchically comprised of several lower-order dimensions subsumed under effortful control, negative affectivity, and surgency. The Children's Behavior Questionnaire-Very Short Form (CBQ-VSF) was developed as a brief measure of the higher-order factors of temperament to aid researchers in…

  10. Brief Report: The Self Harm Questionnaire--A New Tool Designed to Improve Identification of Self Harm in Adolescents

    ERIC Educational Resources Information Center

    Ougrin, Dennis; Boege, Isabel

    2013-01-01

    The Self Harm Questionnaire (SHQ) aiming at identification of self-harm in adolescents has been developed and piloted in a sample of 12-17 year olds (n = 100). The adolescents were recruited from both in- and outpatient psychiatric services. Concurrent validity of the SHQ was evaluated by comparing the SHQ results with recorded self harm in the…

  11. Validation of Self-Report Measures of Physical Activity: A Case Study Using the New Zealand Physical Activity Questionnaire

    ERIC Educational Resources Information Center

    Mackay, Lisa M.; Schofield, Grant M.; Schluter, Philip J.

    2007-01-01

    Accurate measurement of physical activity is fundamentally important in epidemiological research of physical activity behavior. A widely used telephone-based physical activity questionnaire was compared with other methods of administration and objective measures (pedometers and accelerometers) among 80 adults (43 women). The telephone…

  12. Assessing the Psychometric Properties of Kember and Leung's Reflection Questionnaire

    ERIC Educational Resources Information Center

    Lethbridge, Kristen; Andrusyszyn, Mary-Anne; Iwasiw, Carroll; Laschinger, Heather K. S.; Fernando, Rajulton

    2013-01-01

    Reflective thinking is often stated as a learning outcome of baccalaureate nursing education, and as a characteristic of a competent professional; however, no consistent method exists to assess the extent to which students engage in reflective thinking. To address this need, Kember and Leung developed and tested a self-report questionnaire based…

  13. How does your doctor talk with you? Preliminary validation of a brief patient self-report questionnaire on the quality of physician-patient interaction.

    PubMed

    Bieber, Christiane; Müller, Knut G; Nicolai, Jennifer; Hartmann, Mechthild; Eich, Wolfgang

    2010-06-01

    The quality of physician-patient interaction is increasingly being recognized as an essential component of effective treatment. The present article reports on the development and validation of a brief patient self-report questionnaire (QQPPI) that assesses the quality of physician-patient interactions. Data were gathered from 147 patients and 19 physicians immediately after consultations in a tertiary care outpatient setting. The QQPPI displayed good psychometric properties, with high internal consistency and good item characteristics. The QQPPI total score showed variability between different physicians and was independent of patients' gender, age, and education. The QQPPI featured high correlations with other quality-related measures and was not influenced by social desirability, or patients' clinical characteristics. The QQPPI is a brief patient self-report questionnaire that allows assessment of the quality of physician-patient interactions during routine ambulatory care. It can also be used to evaluate physician communication training programs or for educational purposes.

  14. Adverse outcome pathways: From research to regulation scientific workshop report.

    PubMed

    Kleinstreuer, Nicole C; Sullivan, Kristie; Allen, David; Edwards, Stephen; Mendrick, Donna L; Embry, Michelle; Matheson, Joanna; Rowlands, J Craig; Munn, Sharon; Maull, Elizabeth; Casey, Warren

    2016-04-01

    An adverse outcome pathway (AOP) helps to organize existing knowledge on chemical mode of action, starting with a molecular initiating event such as receptor binding, continuing through key events, and ending with an adverse outcome such as reproductive impairment. AOPs can help identify knowledge gaps where more research is needed to understand the underlying mechanisms, aid in chemical hazard characterization, and guide the development of new testing approaches that use fewer or no animals. A September 2014 workshop in Bethesda, Maryland considered how the AOP concept could improve regulatory assessments of chemical toxicity. Scientists from 21 countries, representing industry, academia, regulatory agencies, and special interest groups, attended the workshop, titled Adverse Outcome Pathways: From Research to Regulation. Workshop plenary presentations were followed by breakout sessions that considered regulatory acceptance of AOPs and AOP-based tools, criteria for building confidence in an AOP for regulatory use, and requirements to build quantitative AOPs and AOP networks. Discussions during the closing session emphasized a need to increase transparent and inclusive collaboration, especially with disciplines outside of toxicology. Additionally, to increase impact, working groups should be established to systematically prioritize and develop AOPs. Multiple collaborative projects and follow-up activities resulted from the workshop.

  15. The multidimensional mortality awareness measure and model: development and validation of a new self-report questionnaire and psychological framework.

    PubMed

    Levasseur, Oona; McDermott, Mark R; Lafreniere, Kathryn D

    2015-01-01

    For each of eight literature-identified conceptual dimensions of mortality awareness, questionnaire items were generated, producing 89 in all. A total of 359 participants responded to these items and to questionnaires measuring health attitudes, risk taking, rebelliousness, and demographic variables. Multivariate correlational analyses investigated the underlying structure of the item pool and the construct validity as well as the reliability of the emergent empirically derived subscales. Five components, rather than eight, were identified. Given the item content of each, the associated mortality awareness subscales were labeled as legacy, fearfulness, acceptance, disempowerment, and disengagement. Each attained an acceptable level of internal reliability. Relationships with other variables supported the construct validity of these empirically derived subscales and more generally of this five-factor model. In conclusion, this new multidimensional measure and model of mortality awareness extends our understanding of this important aspect of human existence and supports a more integrative and optimistic approach to mortality awareness than previously available.

  16. An introduction to patient-reported outcome measures in ophthalmic research

    PubMed Central

    Denniston, A K; Kyte, D; Calvert, M; Burr, J M

    2014-01-01

    Clinical outcomes, such as quantifying the extent of visual field loss by automated perimetry, are valued highly by health professionals, but such measures do not capture the impact of the condition on a patient's life. Patient-reported outcomes describe any report or measure of health reported by the patient, without external interpretation by a clinician or researcher. In this review, we discuss the value of the measures that capture this information (patient-reported outcome measures; PROMs), and why they are important to both the clinician and the researcher. We also consider issues around developing or selecting a PROM for ophthalmic research, the emerging challenges around conducting and reporting PROMs in clinical trials and highlight best practice for their use. Search terms for this review comprised: (1) (patient-reported outcomes OR patient-reported outcome measures) AND (2) randomised controlled trials AND (3) limited to ophthalmic conditions. These terms were expanded as follows: (((‘patients'(MeSH Terms) OR ‘patients'(All Fields) OR ‘patient'(All Fields)) AND (‘research report'(MeSH Terms) OR (‘research'(All Fields) AND ‘report'(All Fields)) OR ‘research report'(All Fields) OR ‘reported'(All Fields)) AND outcomes(All Fields)) OR ((‘patients'(MeSH Terms) OR ‘patients'(All Fields) OR ‘patient'(All Fields)) AND (‘research report'(MeSH Terms) OR (‘research'(All Fields) AND ‘report'(All Fields)) OR ‘research report'(All Fields) OR ‘reported'(All Fields) AND (‘outcome assessment (health care)'(MeSH Terms) OR (‘outcome'(All Fields) AND ‘assessment'(All Fields) AND ‘(health'(All Fields) AND ‘care)'(All Fields)) OR ‘outcome assessment (health care)'(All Fields) OR (‘outcome'(All Fields) AND ‘measures'(All Fields)) OR ‘outcome measures'(All Fields)))) AND (‘randomized controlled trial'(Publication Type) OR ‘randomized controlled trials as topic'(MeSH Terms) OR ‘randomised controlled trials'(All Fields) OR

  17. Cognitive and self-reported psychological outcomes of blast-induced mild traumatic brain injury in veterans: a preliminary study.

    PubMed

    Bolzenius, Jacob D; Roskos, P Tyler; Salminen, Lauren E; Paul, Robert H; Bucholz, Richard D

    2015-01-01

    The increased use of explosives in combat has resulted in a large number of returning veterans suffering from blast-related mild traumatic brain injury (mTBI) and self-reported complications. It remains unclear whether this increase in self-reported difficulties is unique to the blast mechanism or stressful preinjury environment and whether cognitive-functioning deficits correspond with these difficulties in the postacute phase. This study examined the relationship between cognitive performance and self-reported psychological and somatic symptoms of blast-related mTBI compared with civilian mTBI, independent of comorbid posttraumatic stress disorder (PTSD) symptoms. Twelve veterans with blast-related mTBI were compared to 18 individuals with civilian mTBI on cognitive tests and self-report questionnaires. Univariate analyses failed to reveal differences on any individual cognitive test. Further, veterans reported more psychological and somatic complaints. These self-reported difficulties were not significantly correlated with neuropsychological performance. Overall, preliminary results suggest that in the postacute phase, subjective complaints related to blast-related mTBI do not covary with objective cognitive performance. Additionally, cognitive outcomes from blast-related mTBI were similar to those of civilian forms of mTBI. Future studies should identify the cognitive and self-reported sequelae of blast-related mTBI independent of comorbid PTSD in a larger sample of veterans.

  18. Brief report: the adolescent Child-to-Parent Aggression Questionnaire: an examination of aggressions against parents in Spanish adolescents.

    PubMed

    Calvete, E; Gamez-Guadix, M; Orue, I; Gonzalez-Diez, Z; Lopez de Arroyabe, E; Sampedro, R; Pereira, R; Zubizarreta, A; Borrajo, E

    2013-12-01

    The objective of this study was to develop a questionnaire to assess child-to-parent aggression in adolescents and to document the extent of the problem. The questionnaire developed in this study, the Child-to-Parent Aggression Questionnaire (CPAQ), includes forms of physical and psychological aggression directed at both the mother and the father. It also includes open questions about the reasons for the aggressive acts. The CPAQ was completed by a sample of 2719 adolescents (age range: 13-18 years old, 51.4% girls). Confirmatory factor analysis supported a four-factor correlated structure (physical aggression against mother, physical aggression against father, psychological aggression against mother, and psychological aggression against father). Psychological and physical aggression against the mother was more frequent than against the father. However, there were no differences with regard to severe forms of aggression. Girls scored significantly higher on all indicators of psychological aggression, including severe psychological aggression. Nevertheless, except for the prevalence of physical aggression against mothers, which was higher in females, there were no significant differences in physical aggression against parents. Finally, the reasons provided by the adolescents for the aggression included both instrumental (e.g., to obtain permission to get home late and to access their computers) and reactive reasons (e.g., anger and self-defense). These findings highlight the complexity of child-to-parent aggression in adolescence.

  19. Measuring mental health and wellbeing outcomes for children and adolescents to inform practice and policy: a review of child self-report measures.

    PubMed

    Deighton, Jessica; Croudace, Tim; Fonagy, Peter; Brown, Jeb; Patalay, Praveetha; Wolpert, Miranda

    2014-01-01

    There is a growing appetite for mental health and wellbeing outcome measures that can inform clinical practice at individual and service levels, including use for local and national benchmarking. Despite a varied literature on child mental health and wellbeing outcome measures that focus on psychometric properties alone, no reviews exist that appraise the availability of psychometric evidence and suitability for use in routine practice in child and adolescent mental health services (CAMHS) including key implementation issues. This paper aimed to present the findings of the first review that evaluates existing broadband measures of mental health and wellbeing outcomes in terms of these criteria. The following steps were implemented in order to select measures suitable for use in routine practice: literature database searches, consultation with stakeholders, application of inclusion and exclusion criteria, secondary searches and filtering. Subsequently, detailed reviews of the retained measures' psychometric properties and implementation features were carried out. 11 measures were identified as having potential for use in routine practice and meeting most of the key criteria: 1) Achenbach System of Empirically Based Assessment, 2) Beck Youth Inventories, 3) Behavior Assessment System for Children, 4) Behavioral and Emotional Rating Scale, 5) Child Health Questionnaire, 6) Child Symptom Inventories, 7) Health of the National Outcome Scale for Children and Adolescents, 8) Kidscreen, 9) Pediatric Symptom Checklist, 10) Strengths and Difficulties Questionnaire, 11) Youth Outcome Questionnaire. However, all existing measures identified had limitations as well as strengths. Furthermore, none had sufficient psychometric evidence available to demonstrate that they could reliably measure both severity and change over time in key groups. The review suggests a way of rigorously evaluating the growing number of broadband self-report mental health outcome measures against

  20. The Instrumental Side of Corporal Punishment: Parents' Reported Practices and Outcome Expectancies.

    ERIC Educational Resources Information Center

    Holden, George W.; Miller, Pamela C.; Harris, Susan D.

    1999-01-01

    Reports on two studies that assessed the relationship between mothers' and fathers' disciplinary practices with three-year-olds and outcome expectancies. Mothers who used corporal punishment at least once a week believed that it was more likely to result in positive outcomes than mothers who never or occasionally spanked. No significant…

  1. Reliability and validity of Arabic translation of Medication Adherence Report Scale (MARS) and Beliefs about Medication Questionnaire (BMQ)–specific for use in children and their parents

    PubMed Central

    Alsous, Mervat; Alhalaiqa, Fadwa; Abu Farha, Rana; Abdel Jalil, Mariam; McElnay, James; Horne, Robert

    2017-01-01

    Objectives to evaluate the reliability and discriminant validity of Arabic translation of the Medication Adherence Report Scale (MARS) and the Beliefs about Medication Questionnaire-specific (BMQ-specific). Methods Having developed Arabic translations of the study instruments, a cross-sectional study was carried out between March and October 2015 in two multidisciplinary governmental hospitals in Jordan. An expert panel monitored the forward and backward translation of the MARS and BMQ. Standard Arabic was used (with no specific dialect inclusion) to allow greater generalisability across Arabic speaking countries. Once the Arabic translations of the questionnaires were developed they were tested for consistency, validity and reliability on a group of children with chronic diseases and their parents. Results A total of 258 parents and 208 children were included in the study. The median age of participated children and parents was 15 years and 42 years respectively. Principle component analysis of all questionnaires indicated that all had good construct validity as they clearly measured one construct. The questionnaires were deemed reliable based on the results of Cronbach alpha coefficient. Furthermore, reliability of the questionnaires was demonstrated by test-retest intraclass correlation coefficients (ICC) which ranged from good to excellent for all scales (ICC>0.706). The Pearson correlation coefficient ranged from 0.546–0.805 for the entire sample which indicated a significant moderate to strong positive correlation between MARS and BMQ items at time 1 and 2. Reported adherence was greater than 59% using MARS-children and MARS-parents scales, and was correlated with beliefs in necessity and independent of the concerns regarding medications. Conclusion The Arabic translations of both BMQ and MARS for use in children and their parents have good internal consistency and proved to be valid and reliable tools that can be used by researchers in clinical practice to

  2. Outcome Reporting in Cardiac Surgery Trials: Systematic Review and Critical Appraisal

    PubMed Central

    Goldfarb, Michael; Drudi, Laura; Almohammadi, Mohammad; Langlois, Yves; Noiseux, Nicolas; Perrault, Louis; Piazza, Nicolo; Afilalo, Jonathan

    2015-01-01

    Background There is currently no accepted standard for reporting outcomes following cardiac surgery. The objective of this paper was to systematically review the literature to evaluate the current use and definition of perioperative outcomes reported in cardiac surgery trials. Methods and Results We reviewed 5 prominent medical and surgical journals on Medline from January 1, 2010, to June 30, 2014, for randomized controlled trials involving coronary artery bypass grafting and/or valve surgery. We identified 34 trials meeting inclusion criteria. Sample sizes ranged from 57 to 4752 participants (median 351). Composite end points were used as a primary outcome in 56% (n=19) of the randomized controlled trials and as a secondary outcome in 12% (n=4). There were 14 different composite end points. Mortality at any time (all-cause and/or cardiovascular) was reported as an individual end point or as part of a combined end point in 82% (n=28), myocardial infarction was reported in 68% (n=23), and bleeding was reported in 24% (n=8). Patient-centered outcomes, such as quality of life and functional classification, were reported in 29% (n=10). Definition of clinical events such as myocardial infarction, stroke, renal failure, and bleeding varied considerably among trials, particularly for postoperative myocardial infarction and bleeding, for which 8 different definitions were used for each. Conclusions Outcome reporting in the cardiac surgery literature is heterogeneous, and efforts should be made to standardize the outcomes reported and the definitions used to ascertain them. The development of standardizing outcome reporting is an essential step toward strengthening the process of evidence-based care in cardiac surgery. PMID:26282561

  3. Does a risk questionnaire add anything to a colorectal screening project? Report of a 3-year screening experience.

    PubMed

    Niv, Y

    1992-07-01

    A questionnaire to detect persons at high risk for colorectal cancer was used in conjunction with fecal occult blood tests in a 3-year screening program in Northern Israel. Screening was offered to 2,590 persons over 40 years of age and accepted by 1,797 (compliance of 69.4%). In the subsequent 2 years, occult blood testing (Hemoccult II) was offered to those who had had negative tests (compliance rate of 99.6% and 100%). Six hundred and thirty persons (35.1%) had risk factors according to the questionnaire, and 195 of them underwent colonoscopy, with a predictive value of 15.9% for a neoplastic lesion. The Hemoccult II test was positive in 71 participants (4.0%) of whom 67 were investigated with a similar predictive value for neoplastic lesion (16.4%). In the second and third annual screening, the fecal occult blood test was positive in 29 (2.6%) and 27 (2.5%), and had a two and three times higher predictive value for neoplastic lesions, respectively. This was accompanied by a decrease in the cost of discovery. In all three stages, an adenomatous polyp was found in 48, and cancer in 10 participants (2.6% and 0.5% of the 1,797 original participants). Although a questionnaire may be fruitful in colorectal cancer screening, the higher number of participants subjected to further examinations makes this approach very expensive. The annual stool examination for occult blood has a higher predictive value for colonic neoplasm and a lower cost than a one stage, broader population based, study.

  4. Incorporating Patient-Reported Outcomes Into Health Care To Engage Patients And Enhance Care.

    PubMed

    Lavallee, Danielle C; Chenok, Kate E; Love, Rebecca M; Petersen, Carolyn; Holve, Erin; Segal, Courtney D; Franklin, Patricia D

    2016-04-01

    The provision of patient-centered care requires a health care environment that fosters engagement between patients and their health care team. One way to encourage patient-centered care is to incorporate patient-reported outcomes into clinical settings. Collecting these outcomes in routine care ensures that important information only the patient can provide is captured. This provides insights into patients' experiences of symptoms, quality of life, and functioning; values and preferences; and goals for health care. Previously embraced in the research realm, patient-reported outcomes have started to play a role in successful shared decision making, which can enhance the safe and effective delivery of health care. We examine the opportunities for using patient-reported outcomes to enhance care delivery and outcomes as health care information needs and technology platforms change. We highlight emerging practices in which patient-reported outcomes provide value to patients and clinicians and improve care delivery. Finally, we examine present and future challenges to maximizing the use of patient-reported outcomes in the clinic.

  5. Evaluation of sexual function outcomes in women undergoing vaginal rejuvenation/vaginoplasty procedures for symptoms of vaginal laxity/decreased vaginal sensation utilizing validated sexual function questionnaire (PISQ-12).

    PubMed

    Moore, Robert D; Miklos, John R; Chinthakanan, Orawee

    2014-03-01

    Sexual function outcomes were analyzed in a group of women (n = 78) presenting for vaginal rejuvenation/vaginoplasty procedure for a chief complaint of vaginal laxity and decreased sensation with intercourse. Outcomes were analyzed utilizing the validated Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12) before and at least 6 months after repair with vaginal rejuvenation/vaginoplasty procedure (VR). Mean age was 43.6 ± 7.9 (range 25-62), and 19 patients (24.3%) were found to have prolapse at time of initial exam and underwent vaginal vault suspension in addition to VR. Compared preoperatively and postoperatively, the overall sexual function (Total PISQ-12) statistically improved (30.3 ± 6.6 vs. 38.2 ± 5.2, P < 0.001). All individual scores statistically improved except in 3 categories in which there was no change (Q1-desire, Q5-pain, and Q11- partner premature ejaculation). Overall sexual satisfaction improved as well as subcategories of increased sexual excitement during intercourse and overall increase in intensity of orgasms. Pain with intercourse subscores were found to be no different from preoperatively to postoperatively. Previous studies have shown that sexual function improves with repair of prolapse; however, this is the first study to show improved function using a validated questionnaire in patients undergoing VR for laxity.

  6. The Importance of Hand Appearance as a Patient-Reported Outcome in Hand Surgery

    PubMed Central

    Johnson, Shepard P.; Sebastin, Sandeep J.; Rehim, Shady A.

    2015-01-01

    Summary: Hand appearance is meaningful to patients because hands are an essential part of human interactions, communication, and social integration. Recent literature indicates that hand aesthetics is an important, measurable patient-reported outcome. In hand surgery, several outcome instruments exist that accurately measure functional outcomes, but aesthetics is often overlooked or imprecisely measured. This makes comparison of disease burden and effectiveness of therapies, as they pertain to aesthetics, difficult. This special topic article outlines the aesthetic features of the hand, how literature is evaluating the appearance of the hand in outcomes research, and proposes a novel approach to assessing hand aesthetics. PMID:26893977

  7. Improving Project Outcomes and Growing the Anaerobic Digestion Industy Report

    EPA Pesticide Factsheets

    Anaerobic digestion ombudsmen assist with project development, ensure the long-term sustainability of projects, and help advance the industry. This report explores the benefits of anaerobic digestion ombudsmen and provides guidance for implementing them.

  8. Quality of life among breast cancer patients with lymphedema: a systematic review of patient-reported outcome instruments and outcomes

    PubMed Central

    Cemal, Yeliz; Albornoz, Claudia; Klassen, Anne; Cano, Stefan; Sulimanoff, Isabel; Hernandez, Marisol; Massey, Marga; Cordeiro, Peter; Morrow, Monica; Mehrara, Babak

    2013-01-01

    Purpose Lymphedema following breast cancer surgery remains a common and feared treatment complication. Accurate information on health-related quality of life (HRQOL) outcomes among patients with lymphedema is critically needed to inform shared medical decision making and evidence-based practice in oncologic breast surgery. Our systematic review aimed to (1) identify studies describing HRQOL outcomes in breast cancer-related lymphedema (BCRL) patients, (2) assess the quality of these studies, and (3) assess the quality and appropriateness of the patient-reported outcome (PRO) instruments used. Methods Using the PRISMA statement, we performed a systematic review including studies describing HRQOL outcomes among BCRL patients. Studies were classified by levels of evidence and fulfillment of the Efficace criteria. PRO instruments were assessed using the COSMIN criteria. Results Thirty-nine studies met inclusion criteria, including 8 level I and 14 level II studies. Sixteen of 39 studies were compliant with the Efficace criteria. Seventeen HRQOL instruments were used, two specific to lymphedema patients. Exercise and complex decongestive therapy treatment interventions were associated with improved HRQOL. Conclusions High-quality data on HRQOL outcomes is required to inform surgical decisions for breast cancer management and survivors. Of the lymphedema-specific PRO instruments, the Upper Limb Lymphedema 27 (ULL-27) was found to have strong psychometric properties. Future studies should strive to use high-quality condition-specific PRO instruments, follow existing guidelines for HRQOL measurement and to consider economic burdens of BCRL. Implications for Cancer Survivors As lymphedema may develop many years after breast cancer surgery, the ULL-27 may offer greater content validity for use in survivorship research. PMID:23212603

  9. Discrepancies in Outcome Reporting Exist Between Protocols and Published Oral Health Cochrane Systematic Reviews

    PubMed Central

    Pandis, Nikolaos; Fleming, Padhraig S.; Worthington, Helen; Dwan, Kerry; Salanti, Georgia

    2015-01-01

    Objectives To assess discrepancies in the analyzed outcomes between protocols and published reviews within Cochrane oral health systematic reviews (COHG) on the Cochrane Database of Systematic Reviews (CDSR). Study Design and Setting All COHG systematic reviews on the CDSR and the corresponding protocols were retrieved in November 2014 and information on the reported outcomes was recorded. Data was collected at the systematic review level by two reviewers independently. Results One hundred and fifty two reviews were included. In relation to primary outcomes, 11.2% were downgraded to secondary outcomes, 9.9% were omitted altogether in the final publication and new primary outcomes were identified in 18.4% of publications. For secondary outcomes, 2% were upgraded to primary, 12.5% were omitted and 30.9% were newly introduced in the publication. Overall, 45.4% of reviews had at least one discrepancy when compared to the protocol; these were reported in 14.5% reviews. The number of review updates appears to be associated with discrepancies between final review and protocol (OR: 3.18, 95% CI: 1.77, 5.74, p<0.001). The risk of reporting significant results was lower for both downgraded outcomes [RR: 0.52, 95% CI: 0.17, 1.58, p = 0.24] and upgraded or newly introduced outcomes [RR: 0.77, 95% CI: 0.36, 1.64, p = 0.50] compared to outcomes with no discrepancies. The risk of reporting significant results was higher for upgraded or newly introduced outcomes compared to downgraded outcomes (RR = 1.19, 95% CI: 0.65, 2.16, p = 0.57). None of the comparisons reached statistical significance. Conclusion While no evidence of selective outcome reporting was found in this study, based on the present analysis of SRs published within COHG systematic reviews, discrepancies between outcomes in pre-published protocols and final reviews continue to be common. Solutions such as the use of standardized outcomes to reduce the prevalence of this issue may need to be explored. PMID:26368938

  10. Ocular trauma treated with pars plana vitrectomy: early outcome report

    PubMed Central

    Mansouri, Mohammad Reza; Tabatabaei, Seyed Ali; Soleimani, Mohammad; Kiarudi, Mohammad Yaser; Molaei, Saber; Rouzbahani, Mehdi; Mireshghi, Meysam; Zaeferani, Mohsen; Ghasempour, Mehrbod

    2016-01-01

    AIM To evaluate demographic variables and visual outcomes, among patients with ocular injuries involving the posterior segment, managed with pars plana vitrectomy. METHODS The records of patients were studied retrospectively from March to September 2010, to determine the age, gender, place of occurrence of trauma, visual acuity, anatomical site, nature of injury, wound length, the presence of an afferent pupillary defect, and the timing of vitrectomy. The Ocular Trauma Score was measured. The minimum follow-up from presentation was 6mo. RESULTS Ninety patients (77 males, 13 females), with a mean age of 32.7±15.8y were included over the 6-month period. The majority of cases occurred in the workplace (47 patients), followed by home (14 patients). The mean visual acuity (logMAR) of patients significantly improved from 2.36±0.72 preoperatively to 1.50±1.14 postoperatively. Twenty-three patients had preoperative vision better than 2.0 logMAR, the postoperative visual acuity was significantly better among these patients than patients with worse than 2.0 logMAR (P<0.001). Visual improvement between groups with early vitrectomy (<7d) and delayed vitrectomy (>7d) was not significantly different (P=0.66). Postoperative visual acuity was not significantly different between patients with injury in Zone I and II (P=0.64), but patients with injury in Zone III had significantly poorer visual acuity (P=0.02). Patients with relative afferent pupillary defect had significantly poorer postoperative visual acuity (P=0.02). Preoperative visual acuity, the difference of preoperative and postoperative visual acuity, and postoperative visual acuity were significantly different between groups with different ocular trauma scores (P<0.001). CONCLUSION Trauma is more likely to occur in men under 40y of age and in the workplace. The favorable final visual outcome is associated with the absence of afferent pupillary defect, ocular trauma score and presenting visual acuity as well as the zone

  11. The Computer-based Health Evaluation Software (CHES): a software for electronic patient-reported outcome monitoring

    PubMed Central

    2012-01-01

    Background Patient-reported Outcomes (PROs) capturing e.g., quality of life, fatigue, depression, medication side-effects or disease symptoms, have become important outcome parameters in medical research and daily clinical practice. Electronic PRO data capture (ePRO) with software packages to administer questionnaires, storing data, and presenting results has facilitated PRO assessment in hospital settings. Compared to conventional paper-pencil versions of PRO instruments, ePRO is more economical with regard to staff resources and time, and allows immediate presentation of results to the medical staff. The objective of our project was to develop software (CHES – Computer-based Health Evaluation System) for ePRO in hospital settings and at home with a special focus on the presentation of individual patient’s results. Methods Following the Extreme Programming development approach architecture was not fixed up-front, but was done in close, continuous collaboration with software end users (medical staff, researchers and patients) to meet their specific demands. Developed features include sophisticated, longitudinal charts linking patients’ PRO data to clinical characteristics and to PRO scores from reference populations, a web-interface for questionnaire administration, and a tool for convenient creating and editing of questionnaires. Results By 2012 CHES has been implemented at various institutions in Austria, Germany, Switzerland, and the UK and about 5000 patients participated in ePRO (with around 15000 assessments in total). Data entry is done by the patients themselves via tablet PCs with a study nurse or an intern approaching patients and supervising questionnaire completion. Discussion During the last decade several software packages for ePRO have emerged for different purposes. Whereas commercial products are available primarily for ePRO in clinical trials, academic projects have focused on data collection and presentation in daily clinical practice and

  12. The Toronto Empathy Questionnaire

    PubMed Central

    Spreng, R. Nathan; McKinnon, Margaret C.; Mar, Raymond A.; Levine, Brian

    2008-01-01

    In order to formulate a parsimonious tool to assess empathy, we used factor analysis on a combination of self-report measures to examine consensus and developed a brief self-report measure of this common factor. The Toronto Empathy Questionnaire (TEQ) represents empathy as a primarily emotional process. In three studies, the TEQ demonstrated strong convergent validity, correlating positively with behavioral measures of social decoding, self-report measures of empathy, and negatively with a measure of Autism symptomatology. Moreover, it exhibited good internal consistency and high test-retest reliability. The TEQ is a brief, reliable, and valid instrument for the assessment of empathy. PMID:19085285

  13. Capturing and Incorporating Patient-Reported Outcomes into Clinical Trials: Practical Considerations for Clinicians.

    PubMed

    Botero, Juliana Perez; Thanarajasingam, Gita; Warsame, Rahma

    2016-10-01

    Patient centeredness as the focus of healthcare delivery requires the incorporation of patient-reported outcomes into clinical trials. Clearly defining measurable outcomes as well as selecting the most appropriate validated collection tool to use is imperative for success. Creating and validating one's own instrument is also possible, albeit more cumbersome. Meticulous data collection to avoid missing data is key, as is limiting the number of data collection points to prevent survey fatigue and using electronic systems to facilitate data gathering and analysis. Working in a multidisciplinary team that includes statisticians with expertise in patient reported outcomes is essential to navigate the complexities of statistical analysis of these variables. Use of available and emerging technologies for data collection and analysis as well as data sharing will greatly facilitate the process of incorporating patient-reported outcomes into trials and routine clinical practice.

  14. Student Self-Reported Learning Outcomes of Field Trips: The pedagogical impact

    NASA Astrophysics Data System (ADS)

    Lavie Alon, Nirit; Tal, Tali

    2015-05-01

    In this study, we used the classification and regression trees (CART) method to draw relationships between student self-reported learning outcomes in 26 field trips to natural environments and various characteristics of the field trip that include variables associated with preparation and pedagogy. We wished to examine the extent to which the preparation for the field trip, its connection to the school curriculum, and the pedagogies used, affect students' self-reported outcomes in three domains: cognitive, affective, and behavioral; and the extent the students' socioeconomic group and the guide's affiliation affect students' reported learning outcomes. Given that most of the field trips were guide-centered, the most important variable that affected the three domains of outcomes was the guide's storytelling. Other variables that showed relationships with self-reported outcomes were physical activity and making connections to everyday life-all of which we defined as pedagogical variables. We found no significant differences in student self-reported outcomes with respect to their socioeconomic group and the guide's organizational affiliation.

  15. A model-based correction for outcome reporting bias in meta-analysis.

    PubMed

    Copas, John; Dwan, Kerry; Kirkham, Jamie; Williamson, Paula

    2014-04-01

    It is often suspected (or known) that outcomes published in medical trials are selectively reported. A systematic review for a particular outcome of interest can only include studies where that outcome was reported and so may omit, for example, a study that has considered several outcome measures but only reports those giving significant results. Using the methodology of the Outcome Reporting Bias (ORB) in Trials study of (Kirkham and others, 2010. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. British Medical Journal 340, c365), we suggest a likelihood-based model for estimating the effect of ORB on confidence intervals and p-values in meta-analysis. Correcting for bias has the effect of moving estimated treatment effects toward the null and hence more cautious assessments of significance. The bias can be very substantial, sometimes sufficient to completely overturn previous claims of significance. We re-analyze two contrasting examples, and derive a simple fixed effects approximation that can be used to give an initial estimate of the effect of ORB in practice.

  16. Evaluation of Relationships Between Reported Resilience and Soldier Outcomes. Report Number 2: Positive Performance Outcomes in Officers (Promotions, Selections, & Professions)

    DTIC Science & Technology

    2011-04-01

    Three items from the UCLA Loneliness scale ( Russell , Peplau, & Cutrona,1980) were used in the GAT. Respondents indicated how often they STRONG MINDS...development. Journal of Research in Personality, 39, 166-184. Russell , D., Peplau, L. A., & Cutrona, C.E. (1980). The Revised UCLA Loneliness Scale...work, have higher levels of organizational trust and friendship, report lower levels of loneliness , are more optimistic, and report higher levels of

  17. Using virtual humans to alleviate social anxiety: preliminary report from a comparative outcome study.

    PubMed

    Robillard, Genevève; Bouchard, Stéphane; Dumoulin, Stéphane; Guitard, Tanya; Klinger, Evelyne

    2010-01-01

    Empirical studies have consistently shown the effectiveness of a multicomponent CBT treatment of social anxiety disorder (SAD). Previous outcome studies on virtual reality and SAD have focused on people suffering from fear of public speaking and not full blown SAD. In this study, 45 adults receiving a DSM-IV-TR diagnostic of social anxiety were randomly assigned to traditional CBT treatment (with in vivo exposure), CBT-VR combined treatment, or a waiting list. Results show significant reduction of anxiety on all questionnaires as well as statistically significant interactions between both treatment groups and the waiting list.

  18. Electronic capture of patient-reported and clinician-reported outcome measures in an elective orthopaedic setting: a retrospective cohort analysis

    PubMed Central

    Malhotra, Karan; Buraimoh, Olatunbosun; Thornton, James; Cullen, Nicholas; Singh, Dishan; Goldberg, Andrew J

    2016-01-01

    Objectives To determine whether an entirely electronic system can be used to capture both patient-reported outcomes (electronic Patient-Reported Outcome Measures, ePROMs) as well as clinician-validated diagnostic and complexity data in an elective surgical orthopaedic outpatient setting. To examine patients' experience of this system and factors impacting their experience. Design Retrospective analysis of prospectively collected data. Setting Single centre series. Outpatient clinics at an elective foot and ankle unit in the UK. Participants All new adult patients attending elective orthopaedic outpatient clinics over a 32-month period. Interventions All patients were invited to complete ePROMs prior to attending their outpatient appointment. At their appointment, those patients who had not completed ePROMs were offered the opportunity to complete it on a tablet device with technical support. Matched diagnostic and complexity data were captured by the treating consultant during the appointment. Outcome measures Capture rates of patient-reported and clinician-reported data. All information and technology (IT) failures, language and disability barriers were captured. Patients were asked to rate their experience of using ePROMs. The scoring systems used included EQ-5D-5L, the Manchester-Oxford Foot Questionnaire (MOxFQ) and the Visual Analogue Scale (VAS) pain score. Results Out of 2534 new patients, 2176 (85.9%) completed ePROMs, of whom 1090 (50.09%) completed ePROMs at home/work prior to their appointment. 31.5% used a mobile (smartphone/tablet) device. Clinician-reported data were captured on 2491 patients (98.3%). The mean patient experience score of using Patient-Reported Outcome Measures (PROMs) was 8.55±1.85 out of 10 and 666 patients (30.61%) left comments. Of patients leaving comments, 214 (32.13%) felt ePROMs did not adequately capture their symptoms and these patients had significantly lower patient experience scores (p<0.001). Conclusions This study

  19. Patient empowerment: The need to consider it as a measurable patient-reported outcome for chronic conditions

    PubMed Central

    2012-01-01

    Background Health policy in the UK and elsewhere is prioritising patient empowerment and patient evaluations of healthcare. Patient reported outcome measures now take centre-stage in implementing strategies to increase patient empowerment. This article argues for consideration of patient empowerment itself as a directly measurable patient reported outcome for chronic conditions, highlights some issues in adopting this approach, and outlines a research agenda to enable healthcare evaluation on the basis of patient empowerment. Discussion Patient empowerment is not a well-defined construct. A range of condition-specific and generic patient empowerment questionnaires have been developed; each captures a different construct e.g. personal control, self-efficacy/self-mastery, and each is informed by a different implicit or explicit theoretical framework. This makes it currently problematic to conduct comparative evaluations of healthcare services on the basis of patient empowerment. A case study (clinical genetics) is used to (1) illustrate that patient empowerment can be a valued healthcare outcome, even if patients do not obtain health status benefits, (2) provide a rationale for conducting work necessary to tighten up the patient empowerment construct (3) provide an exemplar to inform design of interventions to increase patient empowerment in chronic disease. Such initiatives could be evaluated on the basis of measurable changes in patient empowerment, if the construct were properly operationalised as a patient reported outcome measure. To facilitate this, research is needed to develop an appropriate and widely applicable generic theoretical framework of patient empowerment to inform (re)development of a generic measure. This research should include developing consensus between patients, clinicians and policymakers about the content and boundaries of the construct before operationalisation. This article also considers a number of issues for society and for healthcare

  20. [Current biosafety in clinical laboratories in Japan: report of questionnaires' data obtained from clinical laboratory personnel in Japan].

    PubMed

    Goto, Mieko; Yamashita, Tomonari; Misawa, Shigeki; Komori, Toshiaki; Okuzumi, Katsuko; Takahashi, Takashi

    2007-01-01

    To determine the status of biosafety in clinical laboratories in Japan, we conducted a survey using questionnaires on the biosafety of laboratory personnel in 2004. We obtained data from 431 hospitals (response: 59.5%). Respondents were 301 institutions (70%) having biological safety cabinets (BSCs). BSCs were held in 78% of microbiological laboratories, 7.9% of genetic laboratories, 2.7% of histopathological laboratories, and 1% or less at other laboratories. A clean bench in examination rooms for acid-fast bacilli was applied at 20 hospitals. We found 28 cases of possible laboratory-associated tuberculosis infection, 25 of which were associated with lack of BSC. Other risk factors were immature skills and insufficiently skilled eguipment operation. The frequency of rupture accidents during specimen centrifugation was 67% in dealing with blood and 9.7% in collecting acid-fast bacilli. Half or more accidents were related to inadequate sample tube materials. Technologists were shown to be working on blood collection in many hospitals (75%), and 1,534 events of self-inflicted needle puncture developed in the last 5 years. These results suggest that biosafety systems are woefully lacking or inadequate in clinical laboratories in Japan and must be established at the earliest possible opportunity.

  1. Recommendations for reporting independent variables in outcome studies of early and intensive behavioral intervention for autism.

    PubMed

    Lechago, Sarah A; Carr, James E

    2008-07-01

    Early and intensive behavioral intervention (EIBI) has been established as an effective treatment for autism. However, the complexity and intensity of EIBI programs make it difficult to fully report all critical aspects of the independent variable. Consequently, scientific reports of EIBI outcomes have been criticized for providing less than comprehensive treatment descriptions. In an effort to address this problem, the present article provides a template to aid outcome researchers in (a) clearly reporting each participant's curricular targets and (b) describing critical aspects of treatment.

  2. Recommendations for Reporting Independent Variables in Outcome Studies of Early and Intensive Behavioral Intervention for Autism

    ERIC Educational Resources Information Center

    Lechago, Sarah A.; Carr, James E.

    2008-01-01

    Early and intensive behavioral intervention (EIBI) has been established as an effective treatment for autism. However, the complexity and intensity of EIBI programs make it difficult to fully report all critical aspects of the independent variable. Consequently, scientific reports of EIBI outcomes have been criticized for providing less than…

  3. Patient-reported outcomes and associations with pleural effusion in outpatients with heart failure: an observational cohort study

    PubMed Central

    Gundersen, Guri H; Norekvål, Tone M; Graven, Torbjørn; Haug, Hilde H; Skjetne, Kyrre; Kleinau, Jens O; Gustad, Lise T; Dalen, Håvard

    2017-01-01

    Objectives We aimed to study whether patient-reported outcomes, measured by quality of life (QoL) and functional class, are sensitive to pleural effusion (PLE) in patients with heart failure (HF), and to study changes in QoL and functional class during follow-up of PLE. Methods A cohort of 62 patients from an outpatient HF clinic was included. The amount of PLE was quantified using a pocket-sized ultrasound imaging device. Self-reports of QoL and functional class were collected using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the New York Heart Association (NYHA) functional classification. Results At baseline, 26 (42%) patients had PLE of which 19 (31%) patients had moderate to severe amounts of PLE. Patients with no to mild PLE had a lower MLHFQ score (mean 42, SD 21) compared with patients with a moderate to severe amount of PLE (mean 55, SD 24), p=0.03. For 28 patients (45%) with follow-up data, we observed a linear improvement of the MLHFQ-score (3.2, 95% CI 1.2 to 5.1) with each centimetre reduction of PLE. Correspondingly, patient-reported NYHA-class followed the same pattern as the MLHFQ-score. Conclusions Our study indicates that patient-reported outcome measures as MLHFQ may be sensitive tools to identify patients with HF at highest risk of symptomatic PLE and that treatment targeting reduction of PLE during follow-up is essential to improvement of QoL and functional capacity of outpatients with HF. Trial registration number NCT01794715; Results PMID:28320791

  4. Association between mobile phone use and self-reported well-being in children: a questionnaire-based cross-sectional study in Chongqing, China

    PubMed Central

    Zheng, Feizhou; Gao, Peng; He, Mindi; Li, Min; Tan, Jin; Chen, Daiwei; Zhou, Zhou; Yu, Zhengping; Zhang, Lei

    2015-01-01

    Objectives In the past decade, the mobile phone (MP) has become extremely popular among children and the average age at which children own their first MP has decreased. The potential health effects of children’s exposure to MP have been the subject of widespread public concern. The aim of our study is to investigate the associations between MP use and well-being in children. Design Cross-sectional study. Setting The questionnaires were completed in class with items regarding demographics, MP usage, self-reported well-being (symptoms were taken from the questionnaire of the HBSC survey) and possible confounding factors between October 2011 and May 2012 in Chongqing, China. Data were analysed using χ2 tests and logistic regression models. Participants Among the 793 children invited to participate, 781 returned the questionnaires. Results In total, 746 (94.1%) valid questionnaires were received. Fatigue was significantly associated with the years of MP usage (OR 1.85; 95% CI 1.07 to 3.22) and the daily duration of MP calls (OR 2.98; 95% CI 1.46 to 6.12). Headache was significantly associated with the daily duration of MP calls (OR 2.85; 95% CI 1.23 to 6.57). However, after adjusting for confounders only, the association between fatigue and MP usage remained statistically significant. There was no significant association between MP use and other physical symptoms in children. Conclusions The present study indicated that there was a consistent significant association between MP use and fatigue in children. Further in-depth research is needed to explore the potential health effects of MP use in children. PMID:25967996

  5. Prostatic paracoccidioidomycosis with a fatal outcome: a case report

    PubMed Central

    2013-01-01

    Introduction Paracoccidioidomycosis is a systemic mycosis in Latin America that can affect various organs. Few case reports of paracoccidioidomycosis affecting the prostate are found in the literature. Case presentation We present the case of a 79-year-old Caucasian man with a six-month history of irritative symptoms of the prostate (urgency, frequency and nocturia) and difficulty initiating urination that progressed to urinary retention and the use of a urinary catheter. The anatomopathological analysis of the transurethral resection of the prostate revealed chronic granulomatous prostatitis of fungal etiology (paracoccidioidomycosis) with extensive necrosis. The patient began treatment with itraconazole at a dose of 100mg/day for six months. Radiography of the thorax revealed bilaterally diffuse nodular reticular interstitial lesions. The patient progressed to respiratory failure and was sent to the intensive care unit, but suffered a cardiopulmonary arrest and was pronounced dead. Conclusions Due to the high incidence of paracoccidioidomycosis in countries like Brazil, urologists should suspect blastomycosis in all patients with symptoms of lower urinary obstruction with chronic abacterial prostatitis. Considering that paracoccidioidomycosis has the potential to affect various organs, following diagnosis, the treatment must be initiated as soon as possible. PMID:23668825

  6. Therapist-reported alliance: Is it really a predictor of outcome?

    PubMed

    Zilcha-Mano, Sigal; Solomonov, Nili; Chui, Harold; McCarthy, Kevin S; Barrett, Marna S; Barber, Jacques P

    2015-10-01

    Most of the literature on the alliance-outcome association is based exclusively on differences between patient reports on alliance. Much less is known about the unique contribution of the therapist's report to this association across treatment, that is, the association between therapist-reported alliance and outcome over the course of treatment, after controlling for the patient's contribution. The present study is the first to examine the unique contribution of the therapist-reported alliance to outcome, accounting for reverse causation (symptomatic levels predicting alliance), at several time points in the course of treatment. Of 156 patients randomized to dynamic supportive-expressive psychotherapy, antidepressant medication with clinical management, and placebo with clinical management, 149 were included in the present study. Alliance was assessed from the perspective of both the patient and the therapist. Outcome measures included the patients' self-reported and diagnostician-rated depressive symptoms. Overall, the findings demonstrate that the therapists' contribution to the alliance-outcome association was explained mainly by prior symptomatic levels. However, when a time lag of several sessions was introduced between alliance and symptoms, a positive association emerged between alliance at 1 time point and symptomatic distress assessed several sessions later in the treatment, controlling for previous symptomatic level. The findings were similar whether or not we controlled for the patient's perspective on the alliance. Taken together, the findings attest to the importance of improving therapists' ability to detect deterioration in the alliance.

  7. Outcome Reporting Bias in Government-Sponsored Policy Evaluations: A Qualitative Content Analysis of 13 Studies

    PubMed Central

    2016-01-01

    The reporting of evaluation outcomes can be a point of contention between evaluators and policy-makers when a given reform fails to fulfil its promises. Whereas evaluators are required to report outcomes in full, policy-makers have a vested interest in framing these outcomes in a positive light–especially when they previously expressed a commitment to the reform. The current evidence base is limited to a survey of policy evaluators, a study on reporting bias in education research and several studies investigating the influence of industry sponsorship on the reporting of clinical trials. The objective of this study was twofold. Firstly, it aimed to assess the risk of outcome reporting bias (ORB or ‘spin’) in pilot evaluation reports, using seven indicators developed by clinicians. Secondly, it sought to examine how the government’s commitment to a given reform may affect the level of ORB found in the corresponding evaluation report. To answer these questions, 13 evaluation reports were content-analysed, all of which found a non-significant effect of the intervention on its stated primary outcome. These reports were systematically selected from a dataset of 233 pilot and experimental evaluations spanning three policy areas and 13 years of government-commissioned research in the UK. The results show that the risk of ORB is real. Indeed, all studies reviewed here resorted to at least one of the presentational strategies associated with a risk of spin. This study also found a small, negative association between the seniority of the reform’s champion and the risk of ORB in the evaluation of that reform. The publication of protocols and the use of reporting guidelines are recommended. PMID:27690131

  8. Outcome Reporting Bias in Government-Sponsored Policy Evaluations: A Qualitative Content Analysis of 13 Studies.

    PubMed

    Vaganay, Arnaud

    The reporting of evaluation outcomes can be a point of contention between evaluators and policy-makers when a given reform fails to fulfil its promises. Whereas evaluators are required to report outcomes in full, policy-makers have a vested interest in framing these outcomes in a positive light-especially when they previously expressed a commitment to the reform. The current evidence base is limited to a survey of policy evaluators, a study on reporting bias in education research and several studies investigating the influence of industry sponsorship on the reporting of clinical trials. The objective of this study was twofold. Firstly, it aimed to assess the risk of outcome reporting bias (ORB or 'spin') in pilot evaluation reports, using seven indicators developed by clinicians. Secondly, it sought to examine how the government's commitment to a given reform may affect the level of ORB found in the corresponding evaluation report. To answer these questions, 13 evaluation reports were content-analysed, all of which found a non-significant effect of the intervention on its stated primary outcome. These reports were systematically selected from a dataset of 233 pilot and experimental evaluations spanning three policy areas and 13 years of government-commissioned research in the UK. The results show that the risk of ORB is real. Indeed, all studies reviewed here resorted to at least one of the presentational strategies associated with a risk of spin. This study also found a small, negative association between the seniority of the reform's champion and the risk of ORB in the evaluation of that reform. The publication of protocols and the use of reporting guidelines are recommended.

  9. Analyzing clinical trial outcomes based on incomplete daily diary reports.

    PubMed

    Thomas, Neal; Harel, Ofer; Little, Roderick J A

    2016-07-30

    A case study is presented assessing the impact of missing data on the analysis of daily diary data from a study evaluating the effect of a drug for the treatment of insomnia. The primary analysis averaged daily diary values for each patient into a weekly variable. Following the commonly used approach, missing daily values within a week were ignored provided there was a minimum number of diary reports (i.e., at least 4). A longitudinal model was then fit with treatment, time, and patient-specific effects. A treatment effect at a pre-specified landmark time was obtained from the model. Weekly values following dropout were regarded as missing, but intermittent daily missing values were obscured. Graphical summaries and tables are presented to characterize the complex missing data patterns. We use multiple imputation for daily diary data to create completed data sets so that exactly 7 daily diary values contribute to each weekly patient average. Standard analysis methods are then applied for landmark analysis of the completed data sets, and the resulting estimates are combined using the standard multiple imputation approach. The observed data are subject to digit heaping and patterned responses (e.g., identical values for several consecutive days), which makes accurate modeling of the response data difficult. Sensitivity analyses under different modeling assumptions for the data were performed, along with pattern mixture models assessing the sensitivity to the missing at random assumption. The emphasis is on graphical displays and computational methods that can be implemented with general-purpose software. Copyright © 2016 John Wiley & Sons, Ltd.

  10. Parent- and child-reported parenting. Associations with child weight-related outcomes.

    PubMed

    Taylor, Amanda; Wilson, Carlene; Slater, Amy; Mohr, Philip

    2011-12-01

    The present study aimed to investigate associations of both parent-reported and child-perceived parenting styles and parent-reported parenting practices with child weight and weight-related behaviours. Participants were 175 children (56% female) aged between 7 and 11, and their primary caregivers (91% female), recruited through South Australian primary schools. Children completed measures of parenting style, attitude toward fruit, vegetables, and non-core food, and attraction to physical activity. Parents completed measures of parenting style and domain-specific parenting practices (feeding and activity-related practices) and reported on child dietary intake, physical activity, and sedentary behaviour. Objective height and weight measurements were taken from children, from which body mass index (BMI) was calculated. Child-reported parenting style and parent-reported parenting practices were uniquely associated with child weight-related outcomes, but styles and practices did not interact in their association with child outcomes. Child-reported parenting style was associated with child food and activity attitudes, whereas parent-reported parenting style was not associated with child outcomes. The findings of the present study generally support the recommendation of a parenting style high in demandingness and responsiveness for supporting healthy child weight-related behaviours, along with appropriate domain-specific practices. The child's perspective should be incorporated into research involving child outcomes wherever possible.

  11. The Promise of Patient-Reported Outcomes Measurement Information System-Turning Theory into Reality: A Uniform Approach to Patient-Reported Outcomes Across Rheumatic Diseases.

    PubMed

    Witter, James P

    2016-05-01

    PROMIS, the Patient-Reported Outcomes Measurement Information System, is opening new possibilities to explore and learn how patient (or proxy) self-report of core symptoms and health-related quality of life can meaningfully advance clinical research and patient care. PROMIS leverages Item Response Theory to agnostically assess, across diseases and conditions or clinical settings, numerous universally applicable core "domains" of health (symptoms and functioning) from the patient perspective. Importantly, PROMIS is enabling the testing and adoption of computerized adaptive testing, which holds great potential to minimize patient burden while maximizing accuracy.

  12. Residual Effects of Sleep Medications Are Commonly Reported and Associated with Impaired Patient-Reported Outcomes among Insomnia Patients in the United States

    PubMed Central

    Fitzgerald, Timothy; Vietri, Jeffrey

    2015-01-01

    Study Objective. To measure the association of symptoms attributed to residual effects of sleep medication (e.g., drowsiness, difficulty concentrating, and impaired memory) on self-reported functioning and satisfaction with these medications. Methods. Individuals using prescription medications for insomnia were invited to complete an Internet-based survey. Respondents were compared according to the presence of self-reported residual effects; relationships between severity of these effects and outcomes were modeled using regression. Measures included the Brief Insomnia Questionnaire, Work Productivity and Activity Impairment Questionnaire, and SATMED-Q. Subgroup analyses were conducted with patients aged ≥65 years. Approximately 80% reported experiencing ≥1 residual effect. The severity of residual effects was associated with increased residual effect-related work impairment, including absenteeism (RR = 1.46, p < 0.001), presenteeism (RR = 1.12, p < 0.001), overall work impairment (RR = 1.13, p < 0.001), and nonwork activity impairment (RR = 1.11, p < 0.001). More severe residual symptoms were also associated with increased difficulty in home management (Beta = .31, p < 0.001), ability to work (Beta = .31, p < 0.001), social relationships, (Beta = .32, p < 0.001), close personal relationships (Beta = .30, p < 0.001), and lower medication satisfaction (Beta = −.37, p < 0.001). Conclusions. Individuals using medications for insomnia commonly experience symptoms considered as residual effects, and these symptoms are associated with greater interference of sleep-related problems at work, at home, and with social relationships. PMID:26783470

  13. mHealth and big data will bring meaning and value to patient-reported outcomes

    PubMed Central

    2016-01-01

    The intersection of widespread mobile adoption, cloud computing and healthcare will enable patient-reported outcomes to be used to personalize care, draw insights and shorten the cycle from research to clinical implementation. Today, patient-reported outcomes are largely collected as part of a regulatory shift to value-based or bundled care. When patients are able to record their experiences in real-time and combine them with passive data collection from sensors and mobile devices, this information can inform better care for each patient and contribute to the growing body of health data that can be used to draw insights for all patients. This paper explores the current limitations of patient reported outcomes and how mobile health and big data analysis unlocks their potential as a valuable tool to deliver care. PMID:28293580

  14. The roles of funding source, clinical trial outcome, and quality of reporting in orthopedic surgery literature.

    PubMed

    Khan, Safdar N; Mermer, Matthew J; Myers, Elizabeth; Sandhu, Harvinder S

    2008-12-01

    Compared with nonfunded or peer-reviewed funded projects, industry-sponsored clinical trials have traditionally been associated with more positive results. This relationship has been extensively studied in the nonsurgical literature. Although a few authors have addressed specialties, little has been reported on orthopedic clinical trials and their association with funding, study outcome, and efforts to reduce bias after randomization across journals of multiple subspecialties. For the study reported here, we selected 5 major orthopedic subspecialty journals: Journal of Bone and Joint Surgery (American Volume), Spine, Journal of Arthroplasty, Journal of Orthopaedic Trauma, and American Journal of Sports Medicine. We chose a 2-year limit for investigation (2002-2004); included all original randomized clinical trials reported in these 5 journals; and examined these trials for their study design, funding source, outcome, bias potential, and conclusion reached. Support for the 100 eligible orthopedic clinical trials was stated as coming from industry (26 trials, 26%), nonprofit sources (19 trials, 19%), and mixed sources (5 trials, 5%); no support was stated in 46 trials (46%), and support was not reported in 4 trials (4%). Of the 26 trials reporting industry support, 22 (85%) were graded as indicating an outcome favorable to the new treatment. The association between industry funding and favorable outcome was strong and significant (P<.001). In almost half of the studies reported in Journal of Bone and Joint Surgery and Spine, measures taken to reduce bias were not documented.

  15. Patient-reported Outcomes in Asian Patients With Chronic Hepatitis C Treated With Ledipasvir and Sofosbuvir

    PubMed Central

    Younossi, Zobair M.; Stepanova, Maria; Chan, Henry L.Y.; Lee, Mei H.; Yu, Ming-Lung; Dan, Yock Y.; Choi, Moon S.; Henry, Linda

    2016-01-01

    Abstract Prevalence of chronic hepatitis C (CH-C) infection in patients of Asian ancestry ranges between 1% and 20%. Interferon (IFN)- and ribavirin (RBV)-containing regimens for CH-C have a negative impact on patient-reported outcomes (PROs) during treatment. The aim of this study was to assess the impact of IFN-free RBV-free sofosbuvir (SOF)-based regimens on PROs in CH-C patients of Asian ancestry. In this observational retrospective study, the PRO data from 12 multicenter multinational phase 3 clinical trials (2012–2015, conducted in Europe, North America, Australia, and New Zealand) of SOF-based regimens with and without IFN, ledipasvir (LDV), and/or RBV were used. At baseline, during treatment, and post-treatment, patients completed 4 validated PRO questionnaires (SF-36, CLDQ-HCV, FACIT-F, and WPAI:SHP). The resulting PROs in Asian patients were compared across the treatment regimens. Of 4485 of the trials’ participants, 106 patients were of Asian ancestry (55.7% male, 69.8% treatment-naïve, 17.0% cirrhotic). In comparison with other patients, the Asian CH-C cohort was younger, had lower BMI, and lower rates of pre-treatment psychiatric comorbidities (anxiety, depression, sleep disorders) (all P < .05). At baseline, Asian patients also had lower SF-36 physical functioning scores (on average, by −5.6% on a normalized 0–100% PRO scale, P = .001). During treatment, Asian CH-C patients experienced a decline in their PRO scores while receiving IFN and/or RBV-containing regimens (up to −19.6%, P < .001). In contrast, patients receiving LDV/SOF experienced no PRO decrement and improvement of some PRO scores during treatment (+9.0% in general health of SF-36, P = .03). After achieving SVR-12, some of the PRO scores in Asian patients improved regardless of the regimen (up to +9.3%, P < .001). In multivariate analysis of Asian patients, the use of LDV/SOF was independently associated with higher PRO scores during and soon after the end of

  16. Relationship between psychiatric status, self-reported outcome measures, and clinical parameters in axial spondyloarthritis.

    PubMed

    Kilic, Gamze; Kilic, Erkan; Ozgocmen, Salih

    2014-12-01

    This article aims to compare the risks of depression and anxiety in patients with ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpA) and investigate the relationship among self-reported outcome measures, clinical parameters, and physical variables of patients with axSpA. Patients with axSpA were recruited from Erciyes Spondyloarthritis Cohort. The patients met Assessment of Spondyloarthritis International Society classification criteria for axial SpA and were assessed in a cross-sectional study design for visual analog scale (VAS) pain, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Ankylosing Spondylitis Quality of Life questionnaire (ASQoL), and Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP). Psychological status was evaluated using the hospital anxiety and depression scale (HADS). Multivariate logistic regression analysis was applied to determine the associations between psychological variables and clinical parameters after adjusting for confounding variables. Of the 316 patients (142 nr-axSpA, 174 AS), 139 (44%) had high risk for depression (HADS-D score ≥ 7) and 71 (22.5%) for anxiety (HADS-A score ≥ 10). HADS-D and HADS-A scores were similar between patients with AS and nr-axSpA. Patients with high risk for depression and anxiety had higher scores in BASDAI, BASFI, and ASDAS-CRP, and also poorer scores in VAS pain and ASQoL. Multivariate logistic regression analysis showed that the ASDAS-CRP, ASQoL, BASDAI, as well as educational level were factors associated with the risk of depression whereas the ASQoL and educational level were factors associated with the risk of anxiety. Patients with nr-axSpA and AS have similar burden of psychological distress. The quality of life (ASQoL) and educational level were factors associated with the risk of both depression and anxiety whereas disease activity (BASDAI and ASDAS-CRP) was the

  17. Wellness coaching outcomes in a case report of a diabetic native american male.

    PubMed

    Berna, Jennifer S

    2013-07-01

    Medically referred wellness coaching clients may present thinking patterns that generate internal resistance to change, including lack of urgency, inadequate incentives, and uncertainty about what they need to do differently.(1) Applying the Wellcoaches (Wellcoaches Corp, Wellesley, Massachusetts) model interventions within a framework of the four domains of learning (cognitive, affective, behavioral, and conative)2 can enhance wellness coaching outcomes. This case report reviews wellness coaching outcomes with a 44-year-old single male tribal member of a Midwest Native American tribe who recently had been diagnosed with diabetes. Challenges presented by resistance to change and a discussion of the four domains of learning applied to wellness coaching are also reported.

  18. Development of a questionnaire to assess university students’ intentions to use behavioral alcohol reduction strategies

    PubMed Central

    Bonar, Erin E.; Hoffmann, Erica; Rosenberg, Harold; Kryszak, Elizabeth; Young, Kathleen M.; Ashrafioun, Lisham; Kraus, Shane W.; Bannon, Erin E.

    2014-01-01

    Objective To evaluate the psychometric properties of a new self-report questionnaire designed to assess college students’ intentions to employ 31 specific alcohol-reduction strategies. Method Students attending a large public university were recruited to complete alcohol-reduction, drinking history, and personality questionnaires online. Results Based on item-total correlations and principal components analysis, we eliminated three items and calculated average intention ratings across the remaining 28 items. The resulting scale had appropriate unidimensionality and excellent internal consistency. Correlations of intention questionnaire scores with measures of drinking history, alcohol outcome expectancies, sensation seeking, and impression management provided some support for criterion and discriminant validity of the questionnaire. Conclusion This questionnaire could be employed as an outcome measure to evaluate prevention programs and as a clinical tool to identify clients who have little intention to employ drinking reduction strategies in heavy drinking situations. PMID:22686362

  19. Automated Outcome Classification of Computed Tomography Imaging Reports for Pediatric Traumatic Brain Injury

    PubMed Central

    Yadav, Kabir; Sarioglu, Efsun; Choi, Hyeong-Ah; Cartwright, Walter B.; Hinds, Pamela S.; Chamberlain, James M.

    2016-01-01

    Background The authors have previously demonstrated highly reliable automated classification of free text computed tomography (CT) imaging reports using a hybrid system that pairs linguistic (natural language processing) and statistical (machine learning) techniques. Previously performed for identifying the outcome of orbital fracture in unprocessed radiology reports from a clinical data repository, the performance has not been replicated for more complex outcomes. Objectives To validate automated outcome classification performance of a hybrid natural language processing (NLP) and machine learning system for brain CT imaging reports. The hypothesis was that our system has performance characteristics for identifying pediatric traumatic brain injury (TBI). Methods This was a secondary analysis of a subset of 2,121 CT reports from the Pediatric Emergency Care Applied Research Network (PECARN) TBI study. For that project, radiologists dictated CT reports as free text, which were then de-identified and scanned as PDF documents. Trained data abstractors manually coded each report for TBI outcome. Text was extracted from the PDF files using optical character recognition. The dataset was randomly split evenly for training and testing. Training patient reports were used as input to the Medical Language Extraction and Encoding (MedLEE) NLP tool to create structured output containing standardized medical terms and modifiers for negation, certainty, and temporal status. A random subset stratified by site was analyzed using descriptive quantitative content analysis to confirm identification of TBI findings based upon the National Institute of Neurological Disorders and Stroke Common Data Elements project. Findings were coded for presence or absence, weighted by frequency of mentions, and past/future/indication modifiers were filtered. After combining with the manual reference standard, a decision tree classifier was created using data mining tools WEKA 3.7.5 and Salford

  20. Prevalence and symptom profiling of oropharyngeal dysphagia in a community dwelling of an elderly population: a self-reporting questionnaire survey.

    PubMed

    Holland, G; Jayasekeran, V; Pendleton, N; Horan, M; Jones, M; Hamdy, S

    2011-09-01

    Symptomatic dysphagia is believed to be more common in the older population; however, the factors that predict age-related dysphagia are less well-understood. Here, we describe a questionnaire-based survey of swallowing dysfunction in a large, otherwise 'healthy' community dwelling older population in the UK in whom additional cognitive and depression related scores were evaluated. A postal survey using Sydney oropharyngeal dysphagia questionnaire was sent to 800 residences in the North of England that formed part of the University of Manchester Age and Cognitive Performance Longitudinal Study. This cohort was composed of older individuals (mean age 81 [range 69-98 years]) who are otherwise healthy with no history of previous neurological disease. The postal questionnaire is a validated self-report inventory measuring symptoms of oropharyngeal dysphagia covering a total of 17 domains of swallowing function. The maximal score obtainable is 1700, with a score of ≥200 arbitrarily considered to indicate swallowing difficulty. Cognitive performance and depression scores utilized the telephone interview cognitive screen and the Geriatric Depression Scale. All data were analyzed in SPSS. Of the 800 questionnaires sent out, 637 where returned. Three were later discarded as unusable after follow-up telephone interviews of incomplete forms, giving a completed response rate of 79%. Females made up 77% of the total respondents. Of the population, 11.4% reported symptoms indicative of significant dysphagia. Unsurprisingly, dysphagia severity was directly correlated with subject age (r= 0.11, P= 0.007). When cognitive factors were taken into account, there was no correlation between memory, recall, and mental performance and dysphagia; however, depression was strongly and independently associated (P= 0.002) with dysphagia symptoms. Dysphagia symptoms are prevalent in older people, affecting nearly one in nine people who are otherwise living independently in the community

  1. Eating Behaviour among Multi-Ethnic Adolescents in a Middle-Income Country as Measured by the Self-Reported Children’s Eating Behaviour Questionnaire

    PubMed Central

    Loh, Debbie Ann; Moy, Foong Ming; Zaharan, Nur Lisa; Mohamed, Zahurin

    2013-01-01

    Background Escalating weight gain among the Malaysian paediatric population necessitates identifying modifiable behaviours in the obesity pathway. Objectives This study describes the adaptation and validation of the Children’s Eating Behaviour Questionnaire (CEBQ) as a self-report for adolescents, investigates gender and ethnic differences in eating behaviour and examines associations between eating behaviour and body mass index (BMI) z-scores among multi-ethnic Malaysian adolescents. Methodology This two-phase study involved validation of the Malay self-reported CEBQ in Phase 1 (n = 362). Principal Axis Factoring with Promax rotation, confirmatory factor analysis and reliability tests were performed. In Phase 2, adolescents completed the questionnaire (n = 646). Weight and height were measured. Gender and ethnic differences in eating behaviour were investigated. Associations between eating behaviour and BMI z-scores were examined with complex samples general linear model (GLM) analyses, adjusted for gender, ethnicity and maternal educational level. Results Exploratory factor analysis revealed a 35-item, 9-factor structure with ‘food fussiness’ scale split into two. In confirmatory factor analysis, a 30-item, 8-factor structure yielded an improved model fit. Reliability estimates of the eight factors were acceptable. Eating behaviours did not differ between genders. Malay adolescents reported higher Food Responsiveness, Enjoyment of Food, Emotional Overeating, Slowness in Eating, Emotional Undereating and Food Fussiness 1 scores (p<0.05) compared to Chinese and Indians. A significant negative association was observed between BMI z-scores and Food Fussiness 1 (‘dislike towards food’) when adjusted for confounders. Conclusion Although CEBQ is a valuable psychometric instrument, adjustments were required due to age and cultural differences in our sample. With the self-report, our findings present that gender, ethnic and weight status influenced eating

  2. Prediction of Outcome in Diabetic Acute Ischemic Stroke Patients: A Hospital-Based Pilot Study Report

    PubMed Central

    Nayak, Amit R.; Badar, Shweta R.; Lande, Neha; Kawle, Anuja P.; Kabra, Dinesh P.; Chandak, Nitin H.; Raje, Dhananjay V.; Singh, Lokendra R.; Daginawala, Hatim F.; Kashyap, Rajpal S.

    2016-01-01

    Background Demographic and clinical characteristics are known to influence the outcome in acute ischemic stroke (AIS) patients. Purpose This study is aimed at evaluating short- and long-term outcomes in diabetic AIS patients. In addition, the study also evaluates the impact of diabetes on the performance of indigenously reported biomarker, inter-alpha-trypsin inhibitor heavy chain 4 (ITIH4) and known biomarkers, neuron-specific enolase (NSE) and glial-derived S-100 beta beta protein (S-100ββ). Methods This study was performed on 29 diabetes and 75 non-diabetes AIS patients. Outcome of AIS patients was analyzed by using modified Rankin scale at discharge, then at 12 and 18 months after discharge. Based on the obtained scores, patients were classified as improved group (scales 1-3) and dependent/expired group (scales 3-6). Blood samples were collected during admission and at discharge/expired time. Levels of NSE, S100ββ, and ITIH4 were analyzed in all samples. Results On discharge, frequencies of dependent/expired outcome were 4/29 (14%) and 19/75 (17%) in diabetic and non-diabetic AIS patients. However, follow-up outcome at 12 and 18 months showed higher dependent/expired cases of 43 and 41% among diabetic AIS patients compared to 27 and 21% in non-diabetic patients. Multivariate analysis revealed that diabetes is an independent risk factor for dependent/expired outcome in AIS patients (OR 0.484 (at discharge); 1.307 (at 12 months) and 1.675 (at 18 months)). NSE, S100ββ, and ITIH4 showed a differential expression in both the outcome groups of AIS patients, irrespective of diabetes. Conclusion Diabetes increases the risk of dependent/expired outcome in AIS patients. Also, serum NSE, S100ββ, and ITIH4 are independent biomarkers for prognosis of outcome in AIS patients, irrespective of diabetes. PMID:27780987

  3. A methodology for successfully producing global translations of patient reported outcome measures for use in multiple countries.

    PubMed

    Two, Rebecca; Verjee-Lorenz, Aneesa; Clayson, Darren; Dalal, Mehul; Grotzinger, Kelly; Younossi, Zobair M

    2010-01-01

    The production of accurate and culturally relevant translations of patient reported outcome (PRO) measures is essential for the success of international clinical trials. Although there are many reports in publication regarding the translation of PRO measures, the techniques used to produce single translations for use in multiple countries (global translations) are not well documented. This article addresses this apparent lack of documentation and presents the methodology used to create global translations of the Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV). The challenges of creating a translation for use in multiple countries are discussed, and the criteria for a global translation project explained. Based on a thorough translation and linguistic validation methodology including a concept elaboration, multiple forward translations, two back translations, reviews by in-country clinicians and the instrument developer, pilot testing in each target country and multiple sets of proofreading, the key concept of the global translation methodology is consistent international harmonization, achieved through the involvement of linguists from each target country at every stage of the process. This methodology enabled the successful resolution of the translation issues encountered, and resulted in consistent translations of the CLDQ-HCV that were linguistically and culturally appropriate for all target countries.

  4. Mother Reports of Maternal Support Following Child Sexual Abuse: Preliminary Psychometric Data on the Maternal Self-Report Support Questionnaire (MSSQ)

    ERIC Educational Resources Information Center

    Smith, Daniel W.; Sawyer, Genelle K.; Jones, Lisa M.; Cross, Theodore; McCart, Michael R.; Ralston, M. Elizabeth

    2010-01-01

    Objective: Maternal support is an important factor in predicting outcomes following disclosure of child sexual abuse; however, definition of the construct has been unclear and existing measures of maternal support are utilized inconsistently and have limited psychometric data. The purpose of this study was to develop a reliable and valid…

  5. Nurse burnout and patient safety outcomes: nurse safety perception versus reporting behavior.

    PubMed

    Halbesleben, Jonathon R B; Wakefield, Bonnie J; Wakefield, Douglas S; Cooper, Lynn B

    2008-08-01

    This article examines the relationship between nurse burnout and patient safety indicators, including both safety perceptions and reporting behavior. Based on the Conservation of Resources model of stress and burnout, it is predicted that burnout will negatively affect both patient safety perceptions and perceived likelihood of reporting events. Nurses from a Veteran's Administration hospital completed the Maslach Burnout Inventory and safety outcomes subset of measures from the Agency for Healthcare Research and Quality Patient Safety Culture measure. After controlling for work-related demographics, multiple regression analysis supported the prediction that burnout was associated with the perception of lower patient safety. Burnout was not associated with event-reporting behavior but was negatively associated with reporting of mistakes that did not lead to adverse events. The findings extend previous research on the relationship between burnout and patient outcomes and offer avenues for future research on how nurse motivation resources are invested in light of their stressful work environment.

  6. The Survey Questionnaire

    ERIC Educational Resources Information Center

    Ritter, Lois A. Ed.; Sue, Valerie M., Ed.

    2007-01-01

    Internet-based surveys are still relatively new, and researchers are just beginning to articulate best practices for questionnaire design. Online questionnaire design has generally been guided by the principles applying to other self-administered instruments, such as paper-based questionnaires. Web-based questionnaires, however, have the potential…

  7. On the Road to Accountability: Reporting Outcomes for Students with Disabilities. Technical Report.

    ERIC Educational Resources Information Center

    Bielinski, John; Thurlow, Martha; Callender, Stacy; Bolt, Sara

    This fourth annual study reports on state practices in 1999-2000 concerning reporting on the participation and performance of students with disabilities in statewide assessments. Unlike previous reports, the unit of analysis was the state assessments rather than all publicly available print reports. The report describes the assessment systems used…

  8. Research Report on the Nature, Extent, and Outcomes of Accommodations in Adult Education Programs.

    ERIC Educational Resources Information Center

    Mellard, Daryl; Hall, Jean; Leibowitz, Ruth

    This report discusses the current nature, extent, and outcomes of accommodations for adults with disabilities in adult education programs. Information was gathered through a national survey of adult education programs, statewide interviews of adult education instructors, statewide interviews of adult learners with disabilities, literature reviews,…

  9. Student Outcomes Assessment. A Report Submitted to the Administration of Salem-Teikyo University.

    ERIC Educational Resources Information Center

    McAllister, Gary S.

    Salem-Teikyo University (STU) (West Virginia) has been charged with developing a student assessment plan to be fully implemented by 1995. This report is a first step toward this plan, presenting the perspective, paradigms, possibilities, and a proposal for the assessment of student outcomes. The perspective advocated is that of the Center for…

  10. CCP Student Transfer Outcomes at LaSalle University. Institutional Research Report #54.

    ERIC Educational Resources Information Center

    Grosset, Jane

    Focusing on student admission, academic performance, and persistence patterns, this two-part report examines transfer outcomes data on students who attended the Community College of Philadelphia (CCP) and transferred to LaSalle University. The first section presents former CCP student application patterns to LaSalle day and evening divisions…

  11. Voice-Related Patient-Reported Outcome Measures: A Systematic Review of Instrument Development and Validation

    ERIC Educational Resources Information Center

    Francis, David O.; Daniero, James J.; Hovis, Kristen L.; Sathe, Nila; Jacobson, Barbara; Penson, David F.; Feurer, Irene D.; McPheeters, Melissa L.

    2017-01-01

    Purpose: The purpose of this study was to perform a comprehensive systematic review of the literature on voice-related patient-reported outcome (PRO) measures in adults and to evaluate each instrument for the presence of important measurement properties. Method: MEDLINE, the Cumulative Index of Nursing and Allied Health Literature, and the Health…

  12. Early Impacts of the Victorian Training Guarantee on VET Enrolments and Graduate Outcomes. Research Report

    ERIC Educational Resources Information Center

    Leung, Felix; McVicar, Duncan; Polidano, Cain; Zhang, Rong

    2014-01-01

    The impact of the first round of Victorian demand-driven reforms, referred to as the Victorian Training Guarantee (VTG), on enrolments and training outcomes is the focus of this report. The VTG reforms were introduced to create a more responsive training market and were implemented between July 2009 and January 2011. Subsequent reforms introduced…

  13. Exploring the Evidence: Reporting Outcomes of Freshman Seminars. The Freshman Year Experience. Monograph Series Number 11.

    ERIC Educational Resources Information Center

    Barefoot, Betsy O., Ed.

    This document is a compendium of information from 34 colleges and universities on freshman seminar/student success courses and their outcomes and how institutions are evaluating and reporting on these programs. Freshman seminars or success courses are courses for entering students that aim to ease the student's transition to the college…

  14. Educational Funding and Student Outcomes: The Relationship as Evidenced by State-Level Data. Research Reports

    ERIC Educational Resources Information Center

    Carter, Ted

    2014-01-01

    This report shows the impact of various school funding measures on student outcomes measured by NAEP, ACT, and SAT scores, the four-year cohort graduation rate, and percent of the population ages 18-24 with at least a high school diploma. State-level data for the United States from 2005 through 2014 as available is utilized to establish the nature…

  15. Exploring Outcomes and Initial Self-Report of Client Motivation in a College Counseling Center

    ERIC Educational Resources Information Center

    Ilagan, Guy; Vinson, Michael L.; Sharp, Julia L.; Ilagan, Jill; Oberman, Aaron

    2015-01-01

    Objective: To explore the association between college counseling center clients' initial self-report of motivation and counseling outcome. Participants: The sample was composed of 331 student clients who utilized a college counseling center from August 2007 to August 2009. The college is a public, mid-size, urban university in the Southeast.…

  16. Post-operative radiographic factors and patient-reported outcome after total hip replacement.

    PubMed

    Wylde, Vikki; Maclean, Angus; Blom, Ashley W

    2012-01-01

    Although total hip replacement (THR) is considered a very successful surgical intervention, a proportion of patients experience persistent pain or disability, and/or dissatisfaction with the outcome of surgery. Our aim was to determine whether post-operative radiographic variables were predictive of patient-reported pain, function and satisfaction after primary THR. At 1-3 years after surgery patients completed the WOMAC Pain scale, WOMAC Function scale and a validated measure of satisfaction with the outcome of surgery. Post-operative radiographs taken prior to discharge were graded for the restoration of offset, restoration of leg length, anteroposterior (AP) alignment of the femoral stem and AP acetabular inclination. Binary logistic regression was used to identify whether radiographic variables were significant predictors of patient-reported outcome scores. Radiographic and patient-reported outcomes data were available for 452 THR patients. No radiographic predictors were found to be significant predictors of patient reported pain, function or satisfaction at 1-3 years after THR. This highlights that patients with continuing problems after THR may benefit from a thorough multidisciplinary assessment to diagnose the underlying cause of the problems.

  17. Mental Health and Functional Outcomes of Maternal and Adolescent Reports of Adolescent Depressive Symptoms

    ERIC Educational Resources Information Center

    Rice, Frances; Lifford, Kate J.; Thomas, Hollie V.; Thapar, Anita

    2007-01-01

    Objective: To assess the value of maternal and self-ratings of adolescent depression by investigating the extent to which these reports predicted a range of mental health and functional outcomes 4 years later. The potential influence of mother's own depressed mood on her ratings of adolescent depression and suicidal ideation on adolescent outcome…

  18. Student Self-Reported Learning Outcomes of Field Trips: The Pedagogical Impact

    ERIC Educational Resources Information Center

    Alon, Nirit Lavie; Tal, Tali

    2015-01-01

    In this study, we used the classification and regression trees (CART) method to draw relationships between student self-reported learning outcomes in 26 field trips to natural environments and various characteristics of the field trip that include variables associated with preparation and pedagogy. We wished to examine the extent to which the…

  19. Sarilumab improves patient-reported outcomes in rheumatoid arthritis patients with inadequate response/intolerance to tumour necrosis factor inhibitors

    PubMed Central

    Strand, Vibeke; Reaney, Matthew; Chen, Chieh-I; Proudfoot, Clare W J; Guillonneau, Sophie; Bauer, Deborah; Mangan, Erin; Graham, Neil M H; van Hoogstraten, Hubert; Lin, Yong; Pacheco-Tena, César; Fleischmann, Roy

    2017-01-01

    Objective To evaluate effects of the anti-interleukin-6 receptor monoclonal antibody sarilumab administered with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) on patient-reported outcomes (PROs) in the TARGET trial in patients with rheumatoid arthritis (RA) with inadequate response or intolerance to tumour necrosis factor inhibitors (TNF-IR). Methods 546 patients (81.9% female, mean age 52.9 years) were randomised to placebo, sarilumab 150 or 200 mg subcutaneously every 2 weeks + csDMARDs. PROs included patient global assessment (PtGA); pain and morning stiffness visual analogue scales; Health Assessment Questionnaire Disability Index (HAQ-DI); Short Form-36 Health Survey (SF-36); FACIT-Fatigue (FACIT-F); Work Productivity Survey-Rheumatoid Arthritis (WPS-RA) and Rheumatoid Arthritis Impact of Disease (RAID). Changes from baseline at weeks 12 and 24 were analysed using a mixed model for repeated measures; post hoc analyses included percentages of patients reporting improvements ≥ minimum clinically important differences (MCID) and scores ≥ normative values. Results Sarilumab + csDMARDs doses resulted in improvements from baseline at week 12 vs placebo + csDMARDs in PtGA, pain, HAQ-DI, SF-36 and FACIT-F that were maintained at week 24. Sarilumab improved morning stiffness and reduced the impact of RA on work, family, social/leisure activities participation (WPS-RA) and on patients' lives (RAID). Percentages of patients reporting improvements ≥MCID and ≥ normative scores were greater with sarilumab than placebo. Conclusions In patients with TNF-IR RA, 150 and 200 mg sarilumab + csDMARDs resulted in clinically meaningful patient-reported benefits on pain, fatigue, function, participation and health status at 12 and 24 weeks that exceeded placebo + csDMARDs, and were consistent with the clinical profile previously reported. Trial registration number NCT01709578; Results. PMID:28326189

  20. Validity and reliability of the EQ-5D self-report questionnaire in English-speaking Asian patients with rheumatic diseases in Singapore.

    PubMed

    Luo, N; Chew, L H; Fong, K Y; Koh, D R; Ng, S C; Yoon, K H; Vasoo, S; Li, S C; Thumboo, J

    2003-02-01

    Validity and reliability of a Singaporean English EQ-5D self-report questionnaire (EQ-5D) were evaluated among consecutive outpatients with rheumatic diseases attending a tertiary referral hospital in Singapore (a multi-ethnic, urban Asian country). Subjects were interviewed twice within a 2-week period using a standardized questionnaire containing the EQ-5D, Short Form 36 Health Survey (SF-36) and assessing demographic and psychosocial characteristics. To assess validity of the EQ-5D, 13 hypotheses relating responses to EQ-5D dimension/Visual Analogue Scale (EQ-VAS) to SF-36 scores or other variables were examined using the Mann-Whitney test, Kruskal-Wallis test, or Spearman's correlation coefficient. Test-retest reliability was assessed using Cohen's kappa. Sixty-six subjects were studied (osteoarthritis: 9, rheumatoid arthritis: 26, systemic lupus erythematosus: 23, spondyloarthropathy: 8; female: 72.7%; mean age: 44.3 years). Ten of 13 a-priori hypotheses relating EQ-5D responses to external variables were fulfilled, supporting the validity of the EQ-SD. Cohen's kappa for test-retest reliability (n = 52) ranged from 0.29 to 0.61. The Singaporean English EQ-5D appears to be valid in measuring quality of life in Singaporeans with rheumatic diseases; however, its reliability requires further investigation. These data provide a basis for further studies assessing the validity of the EQ-5D in Singapore.

  1. The Reliability and Validity of Liu´s Self-Report Questionnaire for Screening Putative Pre-Psychotic States (BQSPS) in Adolescents

    PubMed Central

    Núñez, D.; Arias, V. B.; Campos, S.

    2016-01-01

    The usage of rigorous analyses based on contemporary methods to enhance psychometric properties of screening questionnaires aimed to address psychotic-like experiences (PLE) is currently being encouraged. The Brief Self-Report Questionnaire for Screening Putative Pre-psychotic States (BQSPS) is a recently created tool addressing PLE beyond attenuated positive symptoms (APS). Its psychometric properties as a screening tool for first step assessment seems to be adequate, but further research is needed to evaluate certain validity aspects, particularly its dimensionality, internal structure, and psychometric properties in different populations. We assessed the reliability, construct validity, and criterion validity of BQSPS in two samples: 727 adolescents aged 13–18 years, and 245 young adults aged 18–33 years. We used exploratory structural equation modeling (ESEM), confirmatory factor analysis (CFA), and Structural Equation Modeling (SEM). The original four-factor structure was not replicated. The best fit in adolescents was obtained by a structure of three-correlated factors: social anxiety (SA), negative symptoms (NS), and positive symptoms (PS). This structure was confirmed in young adult subjects. The three-factor model reached a predictive capability with suicidality as external criterion. PLE are represented by a three-factor structure, which is highly stable between adolescent and young-adult samples. Although the BQSPS seems to be a valid tool for screening PLE, its psychometric properties should be improved to obtain a more accurate measurement. PMID:27973533

  2. Dietary reporting errors on 24 h recalls and dietary questionnaires are associated with BMI across six European countries as evaluated with recovery biomarkers for protein and potassium intake.

    PubMed

    Freisling, Heinz; van Bakel, Marit M E; Biessy, Carine; May, Anne M; Byrnes, Graham; Norat, Teresa; Rinaldi, Sabina; Santucci de Magistris, Maria; Grioni, Sara; Bueno-de-Mesquita, H Bas; Ocké, Marga C; Kaaks, Rudolf; Teucher, Birgit; Vergnaud, Anne-Claire; Romaguera, Dora; Sacerdote, Carlotta; Palli, Domenico; Crowe, Francesca L; Tumino, Rosario; Clavel-Chapelon, Françoise; Boutron-Ruault, Marie-Christine; Khaw, Kay-Tee; Wareham, Nicholas J; Trichopoulou, Antonia; Naska, Androniki; Orfanos, Philippos; Boeing, Heiner; Illner, Anne-Kathrin; Riboli, Elio; Peeters, Petra H; Slimani, Nadia

    2012-03-01

    Whether there are differences between countries in the validity of self-reported diet in relation to BMI, as evaluated using recovery biomarkers, is not well understood. We aimed to evaluate BMI-related reporting errors on 24 h dietary recalls (24-HDR) and on dietary questionnaires (DQ) using biomarkers for protein and K intake and whether the BMI effect differs between six European countries. Between 1995 and 1999, 1086 men and women participating in the European Prospective Investigation into Cancer and Nutrition completed a single 24-HDR, a DQ and one 24 h urine collection. In regression analysis, controlling for age, sex, education and country, each unit (1 kg/m²) increase in BMI predicted an approximately 1·7 and 1·3 % increase in protein under-reporting on 24-HDR and DQ, respectively (both P < 0·0001). Exclusion of individuals who probably misreported energy intake attenuated BMI-related bias on both instruments. The BMI effect on protein under-reporting did not differ for men and women and neither between countries on both instruments as tested by interaction (all P>0·15). In women, but not in men, the DQ yielded higher mean intakes of protein that were closer to the biomarker-based measurements across BMI groups when compared with 24-HDR. Results for K were similar to those of protein, although BMI-related under-reporting of K was of a smaller magnitude, suggesting differential misreporting of foods. Under-reporting of protein and K appears to be predicted by BMI, but this effect may be driven by 'low-energy reporters'. The BMI effect on under-reporting seems to be the same across countries.

  3. Reporting individual surgeon outcomes does not lead to risk aversion in abdominal aortic aneurysm surgery.

    PubMed

    Saratzis, A; Thatcher, A; Bath, M F; Sidloff, D A; Bown, M J; Shakespeare, J; Sayers, R D; Imray, C

    2017-02-01

    INTRODUCTION Reporting surgeons' outcomes has recently been introduced in the UK. This has the potential to result in surgeons becoming risk averse. The aim of this study was to investigate whether reporting outcomes for abdominal aortic aneurysm (AAA) surgery impacts on the number and risk profile (level of fitness) of patients offered elective treatment. METHODS Publically available National Vascular Registry data were used to compare the number of AAAs treated in those centres across the UK that reported outcomes for the periods 2008-2012, 2009-2013 and 2010-2014. Furthermore, the number and characteristics of patients referred for consideration of elective AAA repair at a single tertiary unit were analysed yearly between 2010 and 2014. Clinic, casualty and theatre event codes were searched to obtain all AAAs treated. The results of cardiopulmonary exercise testing (CPET) were assessed. RESULTS For the 85 centres that reported outcomes in all three five-year periods, the median number of AAAs treated per unit increased between the periods 2008-2012 and 2010-2014 from 192 to 214 per year (p=0.006). In the single centre cohort study, the proportion of patients offered elective AAA repair increased from 74% in 2009-2010 to 81% in 2013-2014, with a maximum of 84% in 2012-2013. The age, aneurysm size and CPET results (anaerobic threshold levels) for those eventually offered elective treatment did not differ significantly between 2010 and 2014. CONCLUSIONS The results do not support the assumption that reporting individual surgeon outcomes is associated with a risk averse strategy regarding patient selection in aneurysm surgery at present.

  4. Are outcomes reported in surgical randomized trials patient-important? A systematic review and meta-analysis

    PubMed Central

    Adie, Sam; Harris, Ian A.; Naylor, Justine M.; Mittal, Rajat

    2017-01-01

    Background The dangers of using surrogate outcomes are well documented. They may have little or no association with their patient-important correlates, leading to the approval and use of interventions that lack efficacy. We sought to assess whether primary outcomes in surgical randomized controlled trials (RCTs) are more likely to be patient-important outcomes than surrogate or laboratory-based outcomes. Methods We reviewed RCTs assessing an operative intervention published in 2008 and 2009 and indexed in MEDLINE, EMBASE or the Cochrane Central Register of Controlled Trials. After a pilot of the selection criteria, 1 reviewer selected trials and another reviewer checked the selection. We extracted information on outcome characteristics (patient-important, surrogate, or laboratory-based outcome) and whether they were primary or secondary outcomes. We calculated odds ratios (OR) and pooled in random-effects meta-analysis to obtain an overall estimate of the association between patient importance and primary outcome specification. Results In 350 included RCTs, a total of 8258 outcomes were reported (median 18 per trial. The mean proportion (per trial) of patient-important outcomes was 60%, and 66% of trials specified a patient-important primary outcome. The most commonly reported patient-important primary outcomes were morbid events (41%), intervention outcomes (11%), function (11%) and pain (9%). Surrogate and laboratory-based primary outcomes were reported in 33% and 8% of trials, respectively. Patient-important outcomes were not associated with primary outcome status (OR 0.82, 95% confidence interval 0.63–1.1, I2 = 21%). Conclusion A substantial proportion of surgical RCTs specify primary outcomes that are not patient-important. Authors, journals and trial funders should insist that patient-important outcomes are the focus of study. PMID:28234219

  5. Antimuscarinic Agent Treatment Affecting Patient-Reported Outcomes in Overactive Bladder Syndrome With Depressive Symptoms

    PubMed Central

    2016-01-01

    Purpose We investigated improvements in overactive bladder symptoms and depressive symptoms after solifenacin treatment in overactive bladder patients with or without depressive symptoms. Methods We performed a prospective study of patients who had been diagnosed with overactive bladder from July 2013 to June 2014. Based on the Beck Depression Inventory questionnaire, the test subjects were divided into group 1, without depressive symptoms (0–9 points), and group 2, with depressive symptoms (10 or more points). The patients were administered 5 mg of solifenacin for 3 months. The following outcomes were analyzed at the first visit, 4 weeks, and 12 weeks: the overactive bladder symptom score (OABSS), International Prostate Symptom Score (IPSS), patients’ perceptions of their bladder condition, and the Beck Depression Inventory. Results A total of 72 patients participated, and 52 patients completed the study. Most outcome measures showed improvements in both groups at weeks 4 and 12. Especially in group 2, the questionnaires showed significant improvements from baseline to week 12, indicating that solifenacin was effective at treating overactive bladder symptoms (group 1 vs. group 2: OABSS, −2.67±0.80 vs. −3.00±0.77; P<0.01; IPSS-total, −2.14±2.15 vs. −4.94±1.70; P<0.01). Statistically significant decreases in the Beck Depression Inventory score from baseline to weeks 4 and 12 were observed in group 2 (group 1 vs. group 2: 1.43±0.74 vs. −2.68±4.05 at week 4, P<0.001; 0.10±3.37 vs. −5.52±5.82 at week 12, P<0.001). Conclusions In overactive bladder patients with depressive symptoms, solifenacin can help improve quality of life and depressive symptoms at the same time. PMID:28043114

  6. A Systematic Review of Patient-reported Outcomes in Randomized Controlled Trials of Unplanned General Surgery.

    PubMed

    Stevens, Daniel J; Blencowe, Natalie S; McElnay, Philip J; Macefield, Rhiannon C; Savović, Jelena; Avery, Kerry N L; Blazeby, Jane M

    2016-02-01

    Unplanned general surgery represents a major workload and requires comprehensive evaluation with appropriate outcomes. This study aimed to summarize current reporting of patient-reported outcomes (PROs) in randomized clinical trials (RCTs) in unplanned general surgery. A systematic review identified RCTs reporting PROs in the commonest six areas of unplanned general surgery. Details of the PRO measures were examined using the CONSORT extension for PRO reporting in RCTs. Extracted information about each PRO domain included the reporting of baseline PROs, rationale for PRO selection and whether PRO findings were used in conjunction with clinical outcomes to inform treatment recommendations. The internal validity of included studies was assessed using the Cochrane risk of bias tool. 12,519 abstracts were screened and 20 RCTs containing data from 2037 patients included. Included studies used 14 separate PRO measures covering 35 different health domains. A visual analogue assessment of pain was most frequently reported (n = 13). Reporting of baseline PRO data was uncommon (11/35 PRO domains). The rationale for PRO data collection and a PRO-specific hypothesis were provided for 9 (25.7 %) and 5 (14.3 %) domains, respectively. Seventeen RCTs (85.0 %) used the PRO data alongside clinical outcomes to inform treatment recommendations. Of the 116 risk of bias assessments, 77 (66.0 %) were judged as high or unclear. There is a lack of well designed, and conducted RCTs in unplanned general surgery that include PROs. Future work to define relevant PROs and methods for optimal assessment are needed to inform health care decision-making.

  7. A multidimensional perspective of relations between self-concept (Self Description Questionnaire II) and adolescent mental health (Youth Self-Report).

    PubMed

    Marsh, Herbert W; Parada, Roberto H; Ayotte, Violaine

    2004-03-01

    Relations between self-concept and mental health are best understood from a multidimensional perspective. For responses by 903 adolescents (mean age = 12.6) to a new French translation of the Self Description Questionnaire II (SDQII), confirmatory factor analysis demonstrated a well-defined multidimensional factor structure of reliable, highly differentiated self-concept factors. Correlations between 11 SDQII factors and 7 mental health problems (Youth Self-Report; YSR) varied substantially (.11 to -.83; mean r = -.35). Single higher-order factors could not explain relations among SDQII factors, among YSR factors, or between the SDQII and YSR factors. This highly differentiated multivariate pattern of relations supports a multidimensional perspective of self-concept, not the unidimensional perspective still prevalent in mental health research and assessment.

  8. Primary care follow-up and measured mental health outcomes among women referred for ultrasound assessment of pain and/or bleeding in early pregnancy: a quantitative questionnaire study

    PubMed Central

    Moscrop, Andrew; Harrison, Sian; Heppell, Victoria; Heneghan, Carl; Ward, Alison

    2013-01-01

    Objectives To examine the extent of primary care follow-up and mental health outcomes among women referred for ultrasound assessment of pain and/or bleeding in early pregnancy, including those whose pregnancy is found to be viable on ultrasound assessment. Design Questionnaire study with prospective follow-up. Setting Urgent gynaecology clinic in secondary care, England. Participants 57 women participated in the study. Entry criteria: referral to the urgent gynaecology clinic with pain and/or bleeding in early pregnancy; gestation less than 16 weeks (the clinic's own ‘cut-off’); no previous attendance at the clinic during the current pregnancy. Exclusion criteria: inability to understand English or to provide informed consent. Primary and secondary outcome measures Incidence of primary care follow-up among women referred to the urgent gynaecology clinic; incidence of women with measured mental health scores suggesting significant symptoms of distress. Results Fewer than 1 in 10 women referred for ultrasound assessment of pain and/or bleeding in early pregnancy had follow-up arrangements made with their general practitioner (GP). Most women who had GP follow-up found it helpful and a significant minority of women who did not have GP follow-up felt that it would have been helpful. Following ultrasound assessment, more than one-third of women had significant symptoms of distress. Symptoms of distress, particularly anxiety, were present among those women found to have viable pregnancies, as well as among those with non-viable pregnancies. Conclusions GPs are advised to consider offering follow-up to all women referred for ultrasound assessment of pain and/or bleeding in early pregnancy. Researchers in this area are advised to consider the experiences of women with pain and/or bleeding in early pregnancy whose pregnancies are ultimately found to be viable on ultrasound scan. PMID:23585390

  9. Self-Reported Health Experiences of Children Living with Congenital Heart Defects: Including Patient-Reported Outcomes in a National Cohort Study

    PubMed Central

    Tadic, Valerija; Hogan, Ailbhe; Bull, Catherine; Rahi, Jugnoo Sangeeta; Dezateux, Carol

    2016-01-01

    Background Understanding children’s views about living with congenital heart defects (CHDs) is fundamental to supporting their successful participation in daily life, school and peer relationships. As an adjunct to a health and quality of life outcomes questionnaire, we asked school-age children who survived infant heart procedures to describe their experiences of living with CHDs. Methods In a UK-wide cohort study, children aged 10 to 14 years with CHDs self-completed postal questionnaires that included an open question about having a ‘heart problem’. We compared the characteristics of children with more and less severe cardiac diagnoses and, through collaborative inductive content analysis, investigated the subjective experiences and coping strategies described by children in both clinical severity groups. Results Text and/or drawings were returned by 436 children (246 boys [56%], mean age 12.1 years [SD 1.0; range 10–14]); 313 had less severe (LS) and 123 more severe (MS) cardiac diagnoses. At the most recent hospital visit, a higher proportion of the MS group were underweight (more than two standard deviations below the mean for age) or cyanosed (underweight: MS 20.0%, LS 9.9%; cyanosed: MS 26.2%, LS 3.5%). Children in the MS group described concerns about social isolation and feeling ‘different’, whereas children with less severe diagnoses often characterised their CHD as ‘not a big thing’. Some coping strategies were common to both severity groups, including managing health information to avoid social exclusion, however only children in the LS group considered their CHD ‘in the past’ or experienced a sense of survivorship. Conclusions Children’s reported experiences were not dependent on their cardiac diagnosis, although there were clear qualitative differences by clinical severity group. Children’s concerns emphasised social participation and our findings imply a need to shift the clinical focus from monitoring cardiac function to

  10. Understanding The Strengths And Weaknesses Of Public Reporting Of Surgeon-Specific Outcome Data.

    PubMed

    Burns, Elaine M; Pettengell, Chris; Athanasiou, Thanos; Darzi, Ara

    2016-03-01

    Public reporting of outcome data is increasingly being used at the institutional and clinician levels and has become mandatory in some parts of the United States and the United Kingdom. The intended benefits are to drive quality improvement, demonstrate transparency, facilitate patient choice, and allow identification of poor performance. Public reporting of surgeon-specific mortality data, however, may have unintended consequences that include causing surgeons to become risk-averse, discouraging innovation, having an impact on training, and prompting "gaming" in health care. Given the small number of some surgical operations performed by individual surgeons, such data are unlikely to identify outliers or poor performers in a valid way. If metrics are deemed necessary and required to be reported publicly, they should be procedure specific; account for sample size; and focus not solely on mortality but also on other outcomes such as quality of life, patient satisfaction, and experience.

  11. How should we report early childhood outcomes of very low birth weight infants?

    PubMed

    Vohr, Betty R

    2007-10-01

    Reports of outcomes for very low birth weight infants have evolved from an early focus on survival and neonatal morbidities to the comprehensive analysis and evaluation of the relationships between neonatal interventions and morbidity and neurodevelopmental status in early childhood. Post discharge findings are frequently the primary outcome for antenatal and neonatal intervention trials, and the 97 approved neonatal fellowship training programs in the United States require participation in a follow-up program. Very low birth weight survivors remain at increased risk of neurodevelopmental impairments, vision and hearing impairment, growth failure, behavior morbidities and chronic health problems. Identification of the most appropriate outcome assessment for the study objective, and the ideal timing of the assessment remains a challenge for investigators.

  12. A Systematic Review of Outcome Measures Use, Analytical Approaches, Reporting Methods, and Publication Volume by Year in Low Back Pain Trials Published between 1980 and 2012: Respice, adspice, et prospice

    PubMed Central

    Froud, Robert; Patel, Shilpa; Buchbinder, Rachelle; Eldridge, Sandra; Underwood, Martin

    2016-01-01

    Background Increasing patient-reported outcome measures in the 1980s and 1990s led to the development of recommendations at the turn of the millennium for standardising outcome measures in non-specific low back pain (LBP) trials. Whether these recommendations impacted use is unclear. Previous work has examined citation counts, but actual use and change over time, has not been explored. Since 2011, there has been some consensus on the optimal methods for reporting back pain trial outcomes. We explored reporting practice, outcome measure use, and publications over time. Methods We performed a systematic review of LBP trials, searching the European Guidelines for the management of LBP, extending the search to 2012. We abstracted data on publications by year, outcome measure use, analytical approach, and approaches taken to reporting trials outcomes. Data were analysed using descriptive statistics and regression analyses. Results We included 401 trials. The number of published trials per year has increased by a factor of 4.5 from 5.4 (1980–1999) to 24.4 (2000–2012). The most commonly used outcome measures have been the Visual Analogue Scale for pain intensity, which has slowly increased in use since 1980/81 from 20% to 60% of trials by 2012, and the Roland-Morris Disability Questionnaire, which rose to 55% in 2002/2003, and then fell back to 28% by 2012. Most trialists (85%) report between-group mean differences. Few (8%) report individual improvements, and some (4%) report only within-group analyses. Student’s t test, ANOVA, and ANCOVA regression, or mixed models, were the most common approaches to analysis. Conclusions Recommendations for standardising outcomes may have had a limited or inconsistent effect on practice. Since the research community is again considering outcome measures and modifying recommendations, groups offering recommendations should be cognisant that better ways of generating trialist buy-in may be required in order for their

  13. Psychological Outcomes of Siblings of Cancer Survivors: A Report from the Childhood Cancer Survivor Study

    PubMed Central

    Buchbinder, David; Casillas, Jacqueline; Krull, Kevin R.; Goodman, Pam; Leisenring, Wendy; Recklitis, Christopher; Alderfer, Melissa A.; Robison, Leslie L.; Armstrong, Gregory T.; Kunin-Batson, Alicia; Stuber, Margaret; Zeltzer, Lonnie K.

    2010-01-01

    Objective To identify risk factors for adverse psychological outcomes among adult siblings of long-term survivors of childhood cancer. Methods Cross-sectional, self-report data from 3,083 adult siblings (mean age 29 years, range 18-56 years) of 5+ year survivors of childhood cancer were analyzed to assess psychological outcomes as measured by the Brief Symptom Inventory-18 (BSI-18). Sociodemographic and health data, reported by both the siblings and their matched cancer survivors were explored as risk factors for adverse sibling psychological outcomes through multivariable logistic regression. Results Self-reported symptoms of psychological distress, as measured by the global severity index of the BSI-18, were reported by 3.8% of the sibling sample. Less than 1.5% of siblings reported elevated scores on two or more of the subscales of the BSI-18. Risk factors for sibling depression included having a survivor brother (OR 2.22, 95% CI 1.42-3.55), and having a survivor with impaired general health (OR 2.15, 95% CI 1.18-3.78). Siblings who were younger than the survivor reported increased global psychological distress (OR 1.81, 95% CI 1.05-3.12), as did siblings of survivors reporting global psychological distress (OR 2.32, 95% CI 1.08-4.59). Siblings of sarcoma survivors reported more somatization than did siblings of leukemia survivors (OR 2.07, 95% CI 1.05-3.98). Conclusions These findings suggest that siblings of long-term childhood cancer survivors are psychologically healthy in general. There are, however, small subgroups of siblings at risk for long-term psychological impairment who may benefit from preventive risk-reduction strategies during childhood while their sibling with cancer is undergoing treatment. PMID:22114043

  14. Patient-reported outcomes in post-traumatic stress disorder. Part I: focus on psychological treatment.

    PubMed

    d'Ardenne, Patricia; Heke, Sarah

    2014-06-01

    Since 2000, patient reports have contributed significantly to the widening diagnostic criteria for post-traumatic stress disorder, notably with the inclusion of complex, repeated, and indirect threat to people who develop symptoms. This paper describes and explains why patient reports matter, through worldwide mental health users' movements and the human rights movement. It looks at 46 recent patient-reported outcomes of preferred psychological treatments in clinical research and practice, and compares them with clinician-reported outcomes, using rating scales that diagnose and measure therapeutic gains. Attention is given to one qualitative study of survivors of the London bombings as an example of patients' personal traumatic experiences. Understanding patients' views and their limitations can help increase success in trauma-focused therapy outcomes, particularly where patients fail to engage with or complete treatment, where they doubt the validity of the treatment, or do not see it as culturally appropriate, or fear of revisiting the past. Specific recommendations are made for a more collaborative approach with patients in psychiatric and community care and clinical research.

  15. Patient-reported outcomes in post-traumatic stress disorder Part I: Focus on psychological treatment

    PubMed Central

    d'Ardenne, Patricia; Heke, Sarah

    2014-01-01

    Since 2000, patient reports have contributed significantly to the widening diagnostic criteria for post-traumatic stress disorder, notably with the inclusion of complex, repeated, and indirect threat to people who develop symptoms. This paper describes and explains why patient reports matter, through worldwide mental health users' movements and the human rights movement. It looks at 46 recent patient-reported outcomes of preferred psychological treatments in clinical research and practice, and compares them with clinician-reported outcomes, using rating scales that diagnose and measure therapeutic gains. Attention is given to one qualitative study of survivors of the London bombings as an example of patients' personal traumatic experiences. Understanding patients' views and their limitations can help increase success in trauma-focused therapy outcomes, particularly where patients fail to engage with or complete treatment, where they doubt the validity of the treatment, or do not see it as culturally appropriate, or fear of revisiting the past. Specific recommendations are made for a more collaborative approach with patients in psychiatric and community care and clinical research. PMID:25152659

  16. Pregnancy outcome in patients exposed to direct oral anticoagulants - and the challenge of event reporting.

    PubMed

    Beyer-Westendorf, Jan; Michalski, Franziska; Tittl, Luise; Middeldorp, Saskia; Cohen, Hannah; Abdul Kadir, Rezan; Arachchillage, Deepa Jayakody; Arya, Roopen; Ay, Cihan; Marten, Sandra

    2016-09-27

    Today, direct oral anticoagulants (DOAC) are widely used alternatives to Vitamin-K antagonists (VKA). Women of reproductive age may become pregnant during anticoagulation and, while VKA carry an embryotoxic potential, the risk of DOAC embryopathy is unknown. As a result, some patients elect to terminate pregnancy for fear of DOAC embryotoxicity. To assess the risk of DOAC embryopathy, we reviewed cases of DOAC exposure in pregnancy collected from physicians, literature and pharmacovigilance systems of drug authorities and manufacturers. A total of 357 reports including duplicates were available from which 233 unique cases could be identified. Information on pregnancy outcome was available in only 137/233 cases (58.8 %): 67 live births (48.9 %); 31 miscarriages (22.6 %); 39 elective pregnancy terminations (28.5 %). In 93 cases (39.9 %) no outcome data were available (including 3 cases of ongoing pregnancy). Of the 137 pregnancies with reported outcomes, seven showed abnormalities (5.1 %) of which three (2.2 %) could potentially be interpreted as embryopathy: live birth with facial dysmorphism; miscarriage in week 10 with limb abnormality; elective pregnancy termination due to a foetal cardiac defect in a woman who had to terminate a previous pregnancy due to Fallot tetralogy. Within its limitations (small numbers, incomplete outcome data) our results do not indicate that DOAC exposure in pregnancy carries a high risk of embryopathy or that DOAC exposure per se should be used to direct patient counselling towards pregnancy termination. Pregnancy outcome data are inconsistently captured in pharmacovigilance databases indicating the strong need for a more robust system of reporting.

  17. Nonshaved cranial surgery in black Africans: technical report and a medium-term prospective outcome study.

    PubMed

    Adeleye, Amos O

    2016-07-01

    Nonshaved neurosurgery, cranial or spinal, is well reported among Caucasians but hardly among native Africans. The ungroomed scalp hairs of black Africans have unique anthropological characteristics needing special attention for shaveless cranial surgery. A technical report of the execution of this surgical procedure among an indigenous patient population in a sub-Sahara African country is presented, as well as an outcome analysis in a prospective cohort over a 7-year period. A total of 303 patients (211 males, 70 %) fulfilled the criteria for this study. The surgical procedure was primary in 278 (92 %) and redo in 8 %. It was emergency surgery in 153 (51 %). They were trauma craniotomies or decompressive craniectomies in 95 cases (31 %), craniotomies for tumour resections in 86 (28 %), and the surgical dissections for other conditions in 122 (41 %). The duration of surgery ranged from 30 min to 8.5 h, mean 2.5 (SD, 1.6), median 2. In-hospital clinical outcome was good (normal status or moderate deficit on dichotomized Glasgow outcome scale (GOS)) in 273 (90.1 %) cases while surgical site infections occurred in only 10 cases (3.3 %). The type of surgery, redo or primary, did not have any significant association with the in-hospital outcome (p = 0.5), nor with the presence of surgical site infection (SSI) (p = 0.7). The length of follow-up ranged from 2 to 63 months (mean, 7) with no untoward complications reported so far. Medium-term outcome of nonshaved neurosurgery in this indigenous black Africans remains favourable with no attendant significant adverse after-effects.

  18. Psychometric evaluation of self-report outcome measures for prosthetic applications

    PubMed Central

    Hafner, Brian J.; Morgan, Sara J.; Askew, Robert L.; Salem, Rana

    2016-01-01

    Documentation of clinical outcomes is increasingly expected in delivery of prosthetic services and devices. However, many outcome measures suitable for use in clinical care and research have not been psychometrically tested with prosthesis users. The aim of this study was to determine test-retest reliability, mode-of-administration (MoA) equivalence, standard error of measurement (SEM), and minimal detectable change (MDC) of standardized, self-report instruments that assess constructs of importance to people with lower limb loss. Prosthesis users (n=201) were randomly assigned to groups based on MoA (i.e., paper, electronic, or mixed-mode). Participants completed two surveys 2-3 days apart. Instruments included the Prosthetic Limb Users Survey of Mobility, Prosthesis Evaluation Questionnaire–Mobility Subscale, Activities-Specific Balance Confidence Scale, Quality of Life in Neurological Conditions–Applied Cognition/General Concerns, Patient Reported Outcomes Measurement Information System Profile, and Socket Comfort Score. Intraclass correlation coefficients indicated all instruments are appropriate for group-level comparisons and select instruments are suitable for individual-level applications. Several instruments showed evidence of possible floor and ceiling effects. All were equivalent across MoAs. SEM and MDC were quantified to facilitate interpretation of outcomes and change scores. These results can enhance clinicians' and researchers' ability to select, apply, and interpret scores from instruments administered to prosthesis users. PMID:28273329

  19. Extending basic principles of measurement models to the design and validation of Patient Reported Outcomes.

    PubMed

    Atkinson, Mark J; Lennox, Richard D

    2006-09-22

    A recently published article by the Scientific Advisory Committee of the Medical Outcomes Trust presents guidelines for selecting and evaluating health status and health-related quality of life measures used in health outcomes research. In their article, they propose a number of validation and performance criteria with which to evaluate such self-report measures. We provide an alternate, yet complementary, perspective by extending the types of measurement models which are available to the instrument designer. During psychometric development or selection of a Patient Reported Outcome measure it is necessary to determine which, of the five types of measurement models, the measure is based on; 1) a Multiple Effect Indicator model, 2) a Multiple Cause Indicator model, 3) a Single Item Effect Indicator model, 4) a Single Item Cause Indicator model, or 5) a Mixed Multiple Indicator model. Specification of the measurement model has a major influence on decisions about item and scale design, the appropriate application of statistical validation methods, and the suitability of the resulting measure for a particular use in clinical and population-based outcomes research activities.

  20. Conversion of Questionnaire Data

    SciTech Connect

    Powell, Danny H; Elwood Jr, Robert H

    2011-01-01

    During the survey, respondents are asked to provide qualitative answers (well, adequate, needs improvement) on how well material control and accountability (MC&A) functions are being performed. These responses can be used to develop failure probabilities for basic events performed during routine operation of the MC&A systems. The failure frequencies for individual events may be used to estimate total system effectiveness using a fault tree in a probabilistic risk analysis (PRA). Numeric risk values are required for the PRA fault tree calculations that are performed to evaluate system effectiveness. So, the performance ratings in the questionnaire must be converted to relative risk values for all of the basic MC&A tasks performed in the facility. If a specific material protection, control, and accountability (MPC&A) task is being performed at the 'perfect' level, the task is considered to have a near zero risk of failure. If the task is performed at a less than perfect level, the deficiency in performance represents some risk of failure for the event. As the degree of deficiency in performance increases, the risk of failure increases. If a task that should be performed is not being performed, that task is in a state of failure. The failure probabilities of all basic events contribute to the total system risk. Conversion of questionnaire MPC&A system performance data to numeric values is a separate function from the process of completing the questionnaire. When specific questions in the questionnaire are answered, the focus is on correctly assessing and reporting, in an adjectival manner, the actual performance of the related MC&A function. Prior to conversion, consideration should not be given to the numeric value that will be assigned during the conversion process. In the conversion process, adjectival responses to questions on system performance are quantified based on a log normal scale typically used in human error analysis (see A.D. Swain and H.E. Guttmann

  1. Behavioral Assessment: Questionnaires.

    ERIC Educational Resources Information Center

    Wilson, C. Chrisman

    1980-01-01

    This is a general discussion of the validity, reliability, function, and format of questionnaires designed to measure problem behavior, noncompliance, anxiety, social interaction, hyperactivity, drug use, and sexual behavior. Commonly used questionnaires are cited. (CP)

  2. The Ohio Scales Youth Form: Expansion and Validation of a Self-Report Outcome Measure for Young Children

    ERIC Educational Resources Information Center

    Dowell, Kathy A.; Ogles, Benjamin M.

    2008-01-01

    We examined the validity and reliability of a self-report outcome measure for children between the ages of 8 and 11. The Ohio Scales Problem Severity scale is a brief, practical outcome measure available in three parallel forms: Parent, Youth, and Agency Worker. The Youth Self-Report form is currently validated for children ages 12 and older. The…

  3. Tofacitinib versus methotrexate in rheumatoid arthritis: patient-reported outcomes from the randomised phase III ORAL Start trial

    PubMed Central

    Strand, Vibeke; Lee, Eun Bong; Fleischmann, Roy; Koncz, Tamas; Zwillich, Samuel H; Gruben, David; Wilkinson, Bethanie; Krishnaswami, Sriram; Wallenstein, Gene

    2016-01-01

    Objectives To compare patient-reported outcomes (PROs) in methotrexate (MTX)-naive patients (defined as no prior treatment or ≤3 doses) receiving tofacitinib versus MTX. Methods In the 24-month, phase III, randomised, controlled, ORAL Start trial (NCT01039688), patients were randomised 2:2:1 to receive tofacitinib 5 mg two times per day (n=373), tofacitinib 10 mg two times per day (n=397) or MTX (n=186). PROs assessed included Patient Global Assessment of disease (PtGA), pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and health-related quality of life (Short Form-36 [SF-36]). Results PROs improved following tofacitinib and MTX treatment: benefits were sustained over 24 months. Patients receiving tofacitinib reported earlier responses which were significantly different between each tofacitinib dose and MTX at month 3 through month 24. At month 6 (primary end point), significant improvements versus MTX were observed in PtGA, pain, HAQ-DI, SF-36 Physical Component Summary (PCS), 5/8 domain scores and FACIT-F with tofacitinib 5 mg two times per day; all PROs, except SF-36 Mental Component Summary Score and Medical Outcomes Survey-Sleep, with tofacitinib 10 mg two times per day. At month 6, the proportion of patients reporting improvements ≥minimum clinically important difference were significant versus MTX with tofacitinib 5 mg two times per day in PtGA and 3/8 SF-36 domains; and with tofacitinib 10 mg two times per day in PtGA, pain, HAQ-DI, SF-36 PCS, 4/8 domains and FACIT-F. Conclusions Patients with rheumatoid arthritis receiving tofacitinib 5 and 10 mg two times per day monotherapy versus MTX reported statistically significant and clinically meaningful improvements in multiple PROs over 24 months; onset of benefit with tofacitinib treatment occurred earlier. Trial registration number NCT01039688. PMID:27752357

  4. Core Outcome Set–STAndards for Reporting: The COS-STAR Statement

    PubMed Central

    Kirkham, Jamie J.; Gorst, Sarah; Altman, Douglas G.; Blazeby, Jane M.; Clarke, Mike; Devane, Declan; Moher, David; Schmitt, Jochen; Tugwell, Peter; Tunis, Sean; Williamson, Paula R.

    2016-01-01

    Background Core outcome sets (COS) can enhance the relevance of research by ensuring that outcomes of importance to health service users and other people making choices about health care in a particular topic area are measured routinely. Over 200 COS to date have been developed, but the clarity of these reports is suboptimal. COS studies will not achieve their goal if reports of COS are not complete and transparent. Methods and Findings In recognition of these issues, an international group that included experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives developed the Core Outcome Set–STAndards for Reporting (COS-STAR) Statement as a reporting guideline for COS studies. The developmental process consisted of an initial reporting item generation stage and a two-round Delphi survey involving nearly 200 participants representing key stakeholder groups, followed by a consensus meeting. The COS-STAR Statement consists of a checklist of 18 items considered essential for transparent and complete reporting in all COS studies. The checklist items focus on the introduction, methods, results, and discussion section of a manuscript describing the development of a particular COS. A limitation of the COS-STAR Statement is that it was developed without representative views of low- and middle-income countries. COS have equal relevance to studies conducted in these areas, and, subsequently, this guideline may need to evolve over time to encompass any additional challenges from developing COS in these areas. Conclusions With many ongoing COS studies underway, the COS-STAR Statement should be a helpful resource to improve the reporting of COS studies for the benefit of all COS users. PMID:27755541

  5. Favorable patient reported outcomes following IMRT for early carcinomas of the tonsillar fossa: Results from a symptom assessment study

    PubMed Central

    Gunn, GB; Hansen, CC; Garden, AS; Fuller, CD; Mohamed, ASRM; Morrison, WH; Frank, SJ; Beadle, BM; Phan, J; Chronowski, GM; Sturgis, EM; Lewis, CM; Lu, C; Hutcheson, KA; Mendoza, TR; Cleeland, CS; Rosenthal, DI

    2016-01-01

    Background A questionnaire-based study was conducted to assess long-term patient reported outcomes (PROs) following definitive IMRT-based treatment for early stage carcinomas of the tonsillar fossa. Methods: Participants had received IMRT with or without systemic therapy for squamous carcinoma of the tonsillar fossa (T1-2 and N0-2b) with a minimum follow-up of 2 years. Patients completed a validated head and neck cancer-specific PRO instrument, the MD Anderson Symptom Inventory-Head and Neck module (MDASI-HN). Symptoms were compared between treatment groups of interest and overall symptom burden was evaluated. Results Of 139 participants analyzed, 51% had received ipsilateral neck IMRT, and 62% single modality IMRT alone (no systemic therapy). There were no differences in mean individual symptom and interference ratings for those treated with bilateral versus ipsilateral neck IMRT alone. However, 40% of those treated with bilateral versus 25% of those treated with ipsilateral neck RT alone reported moderate-to-severe levels of dry mouth (p=0.03). Fatigue, numbness/tingling, and constipation were rated more severe for those who had received systemic therapy (p<0.05 for each), but absolute differences were small. Overall, 51% had no more than mild symptom ratings across all 22 symptoms assessed. Conclusions The long-term patient reported symptom profile in this cohort of tonsil cancer survivors treated with definitive IMRT-based treatment showed a majority of patients with no more than mild symptoms, low symptom interference, and provides an opportunity for future comparison studies with other treatment approaches. PMID:26403258

  6. Enhancing periodontal health through regenerative approaches: a commentary on the need for patient-reported outcomes.

    PubMed

    Inglehart, Marita R

    2015-02-01

    Starting in the 1970s, social scientists have discussed the importance of assessing subjective indicators of well-being and quality of life. Medical researchers followed this line of reasoning since the 1990s, emphasizing the significance of understanding how disease and its treatment affect patients' quality of life. Since the start of the 21(st) century, oral health-related quality of life (OHRQoL) received increasingly more attention. While research concerning the effects of periodontal disease and its surgical and non-surgical treatment on patients' lives has been considered in numerous studies, research including patient-reported outcomes when assessing how periodontal health can be enhanced through regenerative approaches is largely missing. This commentary proposes to consider 1) OHRQoL and 2) patients' treatment satisfaction as patient-reported outcomes in conjunction with objectively measured patient-centered factors, and discusses the value of such an approach.

  7. Rationale for Using Social Media to Collect Patient-Reported Outcomes in Patients with Celiac Disease.

    PubMed

    Park, Kt; Harris, Merissa; Khavari, Nasim; Khosla, Chaitan

    2014-02-01

    Patients with celiac disease (CD) are increasingly interconnected through social media, exchanging patient experiences and health-tracking information between individuals through various web-based platforms. Social media represents potentially unique communication interface between gastroenterologists and active social media users - especially young adults and adolescents with celiac disease-regarding adherence to the strict gluten-free diet, gastrointestinal symptoms, and meaningful discussion about disease management. Yet, various social media platforms may be underutilized for research purposes to collect patient-reported outcomes data. In this commentary, we summarize the scientific rationale and potential for future growth of social media in patient-reported outcomes research, focusing on college freshmen with celiac disease as a case study and provide overview of the methodological approach. Finally, we discuss how social media may impact patient care in the future through increasing mobile technology use.

  8. Wellness Coaching Outcomes in a Case Report of a Diabetic Native American Male

    PubMed Central

    2013-01-01

    Medically referred wellness coaching clients may present thinking patterns that generate internal resistance to change, including lack of urgency, inadequate incentives, and uncertainty about what they need to do differently.1 Applying the Wellcoaches (Wellcoaches Corp, Wellesley, Massachusetts) model interventions within a framework of the four domains of learning (cognitive, affective, behavioral, and conative)2 can enhance wellness coaching outcomes. This case report reviews wellness coaching outcomes with a 44-year-old single male tribal member of a Midwest Native American tribe who recently had been diagnosed with diabetes. Challenges presented by resistance to change and a discussion of the four domains of learning applied to wellness coaching are also reported. PMID:24278846

  9. Questionnaire Construction Manual

    DTIC Science & Technology

    1976-07-01

    Questionnaire Results A. Overview 8. Social De ■* ability and Acquiescence Response Sets C. Other Response Sets or Errors D. Effects of General Pretest...Attitudes of Respondents E. Effects of Demographic Characteristics of Responses XIII. Evaluating Questionnaire Results A. Overview B. Scoring...34questionnaire" refers to an ordered arrangement of items (questions, in effect ) intended to elicit the evaluations, judgments, comparisons, attitudes

  10. Laryngeal involvement with fatal outcome in progressive nodular histiocytosis: A rare case report

    PubMed Central

    Salunke, Aarti; Belgaumkar, Vasudha; Chavan, Ravindranath; Dobariya, Rinkesh

    2016-01-01

    Progressive nodular histiocytosis (PNH) represents a very rare type of non-Langerhans cell histiocytosis. It is characterized by progressive appearance of papules and nodules without spontaneous resolution. We report a 60-year-old patient with novel clinical features in the form of extensive noduloulcerative lesions, ichthyotic patches, and laryngeal involvement culminating in fatal outcome prior to therapeutic intervention. Although the presenting features were baffling, histopathology and immunohistochemistry clinched the diagnosis of PNH. PMID:27990389

  11. A Fatal Outcome of Rhino-orbito-cerebral Mucormycosis Following Tooth Extraction: A Case Report

    PubMed Central

    Motaleb, Hesham Y Abdel; Mohamed, Mostafa S; Mobarak, Fahmy A

    2015-01-01

    Rhino-orbito-cerebral mucormycosis is an uncommon aggressive life-threatening opportunistic fungal infection that affects mainly the immunocompromised population with mortality rate up to 50%. Due to its aggressive nature, early detection and prompt management are of great importance for a good prognosis. Our report describes a fatal outcome of a case of rhino-orbito-cerebral mucormycosis following tooth extraction in an uncontrolled non-insulin-dependent diabetes mellitus patient after 14 days of admission. PMID:26225109

  12. A Fatal Outcome of Rhino-orbito-cerebral Mucormycosis Following Tooth Extraction: A Case Report.

    PubMed

    Motaleb, Hesham Y Abdel; Mohamed, Mostafa S; Mobarak, Fahmy A

    2015-01-01

    Rhino-orbito-cerebral mucormycosis is an uncommon aggressive life-threatening opportunistic fungal infection that affects mainly the immunocompromised population with mortality rate up to 50%. Due to its aggressive nature, early detection and prompt management are of great importance for a good prognosis. Our report describes a fatal outcome of a case of rhino-orbito-cerebral mucormycosis following tooth extraction in an uncontrolled non-insulin-dependent diabetes mellitus patient after 14 days of admission.

  13. Prospective assessment of oral mucositis and its impact on quality of life and patient-reported outcomes during radiotherapy for head and neck cancer.

    PubMed

    Franco, Pierfrancesco; Martini, Stefania; Di Muzio, Jacopo; Cavallin, Chiara; Arcadipane, Francesca; Rampino, Monica; Ostellino, Oliviero; Pecorari, Giancarlo; Garzino Demo, Paolo; Fasolis, Massimo; Airoldi, Mario; Ricardi, Umberto

    2017-05-01

    Oral mucositis (OM) is a common acute side effect during radiotherapy treatments for head and neck cancer (HNC), with a potential impact on patient's compliance to therapy, quality of life (QoL) and clinical outcomes. Its timely and appropriate management is of paramount importance. Several quantitative scoring scales are available to properly assess OM and its influence on patient-reported outcomes (PROs) and QoL. We prospectively assessed OM in a cohort of HNC patients submitted to radiation using the Oral Mucositis Assessment Scale (OMAS), while its impact on PROs and QoL was evaluated employing the Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (OMWQ-HN) and the Functional Assessment of Cancer Therapy-Head and Neck Cancer (FACT-HN). Evaluation of OMAS scores highlighted a progressive increase in OM during treatment and a partial recovery after the end of radiation. These trends were correlated to PROs and QoL as evaluated with OMWQ-HN and FACT-HN questionnaires. In the present study, we provided a quantitative assessment of OM, PROs and QoL in HNC patient undergoing radiotherapy, potentially useful for future comparison.

  14. Postpartum Depressive Symptoms Across Time and Place: Structural Invariance of the Self-Reporting Questionnaire Among Women from the International, Multi-Site MAL-ED Study

    PubMed Central

    Pendergast, Laura L.; Scharf, Rebecca J.; Rasmussen, Zeba A.; Seidman, Jessica C.; Schaefer, Barbara A.; Svensen, Erling; Tofail, Fahmida; Koshy, Beena; Kosek, Margaret; Rasheed, Muneera A.; Roshan, Reeba; Maphula, Angelina; Shrestha, Rita; Murray-Kolb, Laura E.

    2014-01-01

    Background The Self-Reporting Questionnaire (SRQ) is a screening instrument that has been shown to be an effective measure of depression in postpartum women and is widely used in developing nations. Methods The SRQ was administered to 2,028 mothers from eight nations at two time points: one and six months postpartum. All data were obtained from the Interactions of Malnutrition and Enteric Infections: Consequences for Child Health and Development (MAL-ED) study. The sample included women from MAL-ED sites in Bangladesh, Brazil, India, Nepal, Pakistan, Peru, South Africa, and Tanzania. This study examined three aspects of validity of SRQ scores including (a) structural validity, (b) cross-cultural invariance, and (c) invariance over time. Results A 16-item, one-factor structure with items reflecting somatic symptoms removed was deemed to be superior to the original structure in this postpartum population. Although differential item functioning (DIF) across sites was evident, the one-factor model was a good fit to the data from seven sites, and the structure was invariant across the one- and six-month time points. Limitations Findings are based on data from self-report scales. No information about the clinical status of the participants was available. Conclusions Overall, findings support the validity of a modified model of the SRQ among postpartum women. Somatic symptoms (e.g., headaches, not sleeping well) may not reflect internalizing problems in a postpartum population. Implications for researchers and practitioners are discussed. PMID:24981251

  15. Interactions between voice clinics and singing teachers: a report on the British Voice Association questionnaire to voice clinics in the UK.

    PubMed

    Davies, J; Anderson, S; Huchison, L; Stewart, G

    2007-01-01

    Singers with vocal problems are among patients who present at multidisciplinary voice clinics led by Ear Nose and Throat consultants and laryngologists or speech and language therapists. However, the development and care of the singing voice are also important responsibilities of singing teachers. We report here on the current extent and nature of interactions between voice clinics and singing teachers, based on data from a recent survey undertaken on behalf of the British Voice Association. A questionnaire was sent to all 103 voice clinics at National Health Service (NHS) hospitals in the UK. Responses were received and analysed from 42 currently active clinics. Eight (19%) clinics reported having a singing teacher as an active member of the team. They were all satisfied with the singing teacher's knowledge and expertise, which had been acquired by several different means. Of 32 clinics without a singing teacher regularly associated with the team, funding and difficulty of finding an appropriate singing voice expert (81% and 50%, respectively) were among the main reasons for their absence. There was an expressed requirement for more interaction between voice clinics and singing teachers, and 86% replied that they would find it useful to have a list of singing teachers in their area. On the matter of gaining expertise and training, 74% of the clinics replying would enable singing teachers to observe clinic sessions for experience and 21% were willing to assist in training them for clinic-associated work.

  16. Cross-cultural validation of the Falls Efficacy Scale International (FES-I) using self-report and interview-based questionnaires among Persian-speaking elderly adults.

    PubMed

    Baharlouei, Hamzeh; Salavati, Mahyar; Akhbari, Behnam; Mosallanezhad, Zahra; Mazaheri, Masood; Negahban, Hossein

    2013-01-01

    FES-I has been designed to assess fear of falling (FoF). The purpose of this study was to establish the Persian-language version of the FES-I and to assess its psychometric properties under different modes of administration: self-report and interview-based. Participants included 191 elderly people aged over 60 who were mostly community dwelling. With an interval of 14 days, 97 volunteers completed the questionnaire in the retest session. To evaluate the construct validity, we assessed the ability of the FES-I to discriminate people based on gender, level of education, number of falls and FoF. The correlation with the Short Form of Health Survey (SF-36), Timed Up and Go (TUG) and Functional Reach Test (FRT) was also determined to test validity. Internal consistency was excellent in both self-report (0.93) and interview (0.92) versions. All intra-class correlations (ICCs) were above 0.70 with the highest reliability obtained for the condition where the interview based FES-I was used in both test and retest sessions. The strength of correlation between the FES-I and TUG varied based on mode of administration: moderate for interview and high for self-report mode. The FES-I had a higher correlation with the SF-36 subscales of physical health than subscales of mental health. The FES-I had the ability to discriminate the participants based on gender, educational level, and number of falls and FoF. In conclusion, both interview and self-report versions of the FES-I demonstrated acceptable measurement properties to assess FoF in Iranian elderly persons.

  17. Systematic Review of Radiation Therapy Toxicity Reporting in Randomized Controlled Trials of Rectal Cancer: A Comparison of Patient-Reported Outcomes and Clinician Toxicity Reporting

    SciTech Connect

    Gilbert, Alexandra; Ziegler, Lucy; Martland, Maisie; Davidson, Susan; Efficace, Fabio; Sebag-Montefiore, David; Velikova, Galina

    2015-07-01

    The use of multimodal treatments for rectal cancer has improved cancer-related outcomes but makes monitoring toxicity challenging. Optimizing future radiation therapy regimens requires collection and publication of detailed toxicity data. This review evaluated the quality of toxicity information provided in randomized controlled trials (RCTs) of radiation therapy in rectal cancer and focused on the difference between clinician-reported and patient-reported toxicity. Medline, EMBASE, and the Cochrane Library were searched (January 1995-July 2013) for RCTs reporting late toxicity in patients treated with regimens including preoperative (chemo)radiation therapy. Data on toxicity measures and information on toxicity reported were extracted using Quantitative Analyses of Normal Tissue Effects in the Clinic recommendations. International Society for Quality of Life Research standards on patient-reported outcomes (PROs) were used to evaluate the quality of patient-reported toxicity. Twenty-one RCT publications met inclusion criteria out of 4144 articles screened. All PRO studies reported higher rates of toxicity symptoms than clinician-reported studies and reported on a wider range and milder symptoms. No clinician-reported study published data on sexual dysfunction. Of the clinician-reported studies, 55% grouped toxicity data related to an organ system together (eg “Bowel”), and 45% presented data only on more-severe (grade ≥3) toxicity. In comparison, all toxicity grades were reported in 79% of PRO publications, and all studies (100%) presented individual symptom toxicity data (eg bowel urgency). However, PRO reporting quality was variable. Only 43% of PRO studies presented baseline data, 28% did not use any psychometrically validated instruments, and only 29% of studies described statistical methods for managing missing data. Analysis of these trials highlights the lack of reporting standards for adverse events and reveals the differences between clinician and

  18. Maternal reports of satisfaction with care and outcomes for children with craniosynostosis.

    PubMed

    Wong-Gibbons, Donna L; Kancherla, Vijaya; Romitti, Paul A; Tyler, Margaret C; Damiano, Peter C; Druschel, Charlotte M; Robbins, James M; Kizelnik-Freilich, Sara; Burnett, Whitney

    2009-01-01

    Craniosynostosis is a congenital deformity caused by premature fusion of cranial suture(s). Surgical outcomes of craniosynostosis have been well documented; however, limited published data are available regarding access to care and social and psychological health outcomes for children with craniosynostosis. The authors conducted a population-based, multistate study of maternal perceptions of care and outcomes for children with craniosynostosis born from January 1998 through December 2003. Mothers of 147 children were contacted and asked to complete a structured telephone interview; 82 mothers (55.8%) participated. Overall, the mean ages of children and their mothers at the time of interview were 4.4 and 34.8 years, respectively. Mothers interviewed tended to be white and, at a minimum, high school graduates. Most mothers reported being satisfied with the craniosynostosis-related information and support provided by medical care providers, and access to primary and specialty care was most often rated as satisfactory. Mothers tended to report the physical health of their child to be good; however, delays in cognitive and emotional development, hearing loss, and speech problems were identified. In addition, statistically significant differences among mothers in each state were noted for reports of the quality of team care, primary care, learning interventions, and perceived need for additional surgeries. These results suggest some limitations in craniosynostosis-related care and provide guidance to medical and surgical care providers in making need-based improvements in craniosynostosis surgery and care. Future studies are recommended to replicate this evaluation in additional populations.

  19. A single institution study on patient's self-reporting appraisal and functional outcomes of the first set of men following radical perineal prostatectomy

    PubMed Central

    Słupski, Piotr; Wiśniewski, Przemysław

    2012-01-01

    Introduction This study evaluates the functional outcomes and satisfaction of an initial series of 47 patients after radical perineal prostatectomy performed in our department. Material and methods The first set of 47 consecutive patients underwent perineal prostatectomy during 2008 and 2009. Continence, sexual outcomes, and satisfaction of the treatment were evaluated using a self-reporting questionnaire, which was mailed to all patients after 15 to 33 months of follow-up. 26 patients (55.3%) returned a completed form and participated in the study. Additionally, final outcomes were compared to results reported elsewhere. Results Amid respondents, 91.7% were satisfied with the chosen treatment and 8.3% regret the previous decision. 38.5% patients reported any urine leakage, 15.4% drip up to 100 ml a day, and only one patient (3.8%) was totally incontinent. 76.9% men report a decline in prior sexual function. Six patients (23.1%) patients have any degree of spontaneous erections and undertake sexual activity. However, as erectile outcomes are adjusted to nine nerve-sparing cases, 66.7% have spontaneous erections and 55.5% undertake sexual activity, but only 40% of them describe their sexual function as satisfying. Conclusions Our survey demonstrates that, because of short operating time, fast recovery, low postoperative pain score, early patient mobilization and feeding, and a small (8-10 cm) and inconspicuous skin incision, radical perineal prostatectomy fully deserves to be recognized as a low-morbidity procedure. The perineal approach provides a quality of life and patients satisfaction rate comparable to trendy, highly equipped procedures and emerges as an attractive alternative to them. Even novice “perineal surgeons” may achieve favorable results. PMID:24578947

  20. Bilateral Arthrodesis of the Ankle Joint: Self-Reported Outcomes in 35 Patients From the Swedish Ankle Registry.

    PubMed

    Henricson, Anders; Kamrad, Ilka; Rosengren, Björn; Carlsson, Åke

    Bilateral ankle arthrodesis is seldom performed, and results concerning the outcome and satisfaction can only sparsely be found in published studies. We analyzed the data from 35 patients who had undergone bilateral ankle arthrodesis in the Swedish Ankle Registry using patient-reported generic and region-specific outcome measures. Of 36 talocrural arthrodeses and 34 tibio-talar-calcaneal arthrodeses, 6 ankles (9%) had undergone repeat arthrodesis because of nonunion. After a mean follow-up period of 47 ± 5 (range 12 to 194) months, the mean scores were as follows: self-reported foot and ankle score, 33 ± 10 (range 4 to 48); the EuroQol Group's EQ-5D(™) score, 0.67 ± 0.28 (range -0.11 to 1), the EuroQol Group's visual analog scale score, 70 ± 19 (range 20 to 95), 36-item Short Form Health Survey (SF-36) physical domain, 39 ± 11 (range 16 to 58); and SF-36 mental domain, 54 ± 14 (range 17 to 71). Patients with rheumatoid arthritis seemed to have similar self-reported foot and ankle scores but possibly lower EQ-5D(™) and SF-36 scores. Those with talocrural arthrodeses scored higher than did those with tibio-talar-calcaneal arthrodeses on the EQ5D(™) and SF-36 questionnaires (p = .03 and p = .04). In 64 of 70 ankles (91%), the patients were satisfied or very satisfied with the outcome. In conclusion, we consider bilateral ankle arthrodesis to be a reasonable treatment for symptomatic hindfoot arthritis, with high postoperative mid-term satisfaction and satisfactory scores on the patient-reported generic and region-specific outcome measures, when no other treatment option is available.

  1. Systematic review of patient-reported outcome measures (PROMs) for assessing disease activity in rheumatoid arthritis

    PubMed Central

    de Jonge, Marieke J; Fransen, Jaap; Kievit, Wietske; van Riel, Piet LCM

    2016-01-01

    Patient assessment of disease activity in rheumatoid arthritis (RA) may be useful in clinical practice, offering a patient-friendly, location independent, and a time-efficient and cost-efficient means of monitoring the disease. The objective of this study was to identify patient-reported outcome measures (PROMs) to assess disease activity in RA and to evaluate the measurement properties of these measures. Systematic literature searches were performed in the PubMed and EMBASE databases to identify articles reporting on clinimetric development or evaluation of PROM-based instruments to monitor disease activity in patients with RA. 2 reviewers independently selected articles for review and assessed their methodological quality based on the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) recommendations. A total of 424 abstracts were retrieved for review. Of these abstracts, 56 were selected for reviewing the full article and 34 articles, presenting 17 different PROMs, were finally included. Identified were: Rheumatoid Arthritis Disease Activity Index (RADAI), RADAI-5, Patient-based Disease Activity Score (PDAS) I & II, Patient-derived Disease Activity Score with 28-joint counts (Pt-DAS28), Patient-derived Simplified Disease Activity Index (Pt-SDAI), Global Arthritis Score (GAS), Patient Activity Score (PAS) I & II, Routine Assessment of Patient Index Data (RAPID) 2–5, Patient Reported Outcome-index (PRO-index) continuous (C) & majority (M), Patient Reported Outcome CLinical ARthritis Activity (PRO-CLARA). The quality of reports varied from poor to good. Typically 5 out of 10 clinimetric domains were covered in the validations of the different instruments. The quality and extent of clinimetric validation varied among PROMs of RA disease activity. The Pt-DAS28, RADAI, RADAI-5 and RAPID 3 had the strongest and most extensive validation. The measurement properties least reported and in need of more evidence were: reliability

  2. A 14-year retrospective maternal report of alcohol consumption in pregnancy predicts pregnancy and teen outcomes.

    PubMed

    Hannigan, John H; Chiodo, Lisa M; Sokol, Robert J; Janisse, James; Ager, Joel W; Greenwald, Mark K; Delaney-Black, Virginia

    2010-01-01

    Detecting patterns of maternal drinking that place fetuses at risk for fetal alcohol spectrum disorders (FASDs) is critical to diagnosis, treatment, and prevention but is challenging because information on antenatal drinking collected during pregnancy is often insufficient or lacking. Although retrospective assessments have been considered less favored by many researchers due to presumed poor reliability, this perception may be inaccurate because of reduced maternal denial and/or distortion. The present study hypothesized that fetal alcohol exposure, as assessed retrospectively during child adolescence, would be related significantly to prior measures of maternal drinking and would predict alcohol-related behavioral problems in teens better than antenatal measures of maternal alcohol consumption. Drinking was assessed during pregnancy, and retrospectively about the same pregnancy, at a 14-year follow-up in 288 African-American women using well-validated semistructured interviews. Regression analysis examined the predictive validity of both drinking assessments on pregnancy outcomes and on teacher-reported teen behavior outcomes. Retrospective maternal self-reported drinking assessed 14 years postpartum was significantly higher than antenatal reports of consumption. Retrospective report identified 10.8 times more women as risk drinkers (≥ one drink per day) than the antenatal report. Antenatal and retrospective reports were moderately correlated and both were correlated with the Michigan Alcoholism Screening Test. Self-reported alcohol consumption during pregnancy based on retrospective report identified significantly more teens exposed prenatally to at-risk alcohol levels than antenatal, in-pregnancy reports. Retrospective report predicted more teen behavior problems (e.g., attention problems and externalizing behaviors) than the antenatal report. Antenatal report predicted younger gestational age at birth and retrospective report predicted smaller birth size

  3. Outcome, revision rate and indication for revision following resurfacing hemiarthroplasty for osteoarthritis of the shoulder: 837 operations reported to the Danish Shoulder Arthroplasty Registry.

    PubMed

    Rasmussen, J V; Polk, A; Sorensen, A K; Olsen, B S; Brorson, S

    2014-04-01

    In this study, we evaluated patient-reported outcomes, the rate of revision and the indications for revision following resurfacing hemiarthroplasty of the shoulder in patients with osteoarthritis. All patients with osteoarthritis who underwent primary resurfacing hemiarthroplasty and reported to the Danish Shoulder Arthroplasty Registry (DSR), between January 2006 and December 2010 were included. There were 772 patients (837 arthroplasties) in the study. The Western Ontario Osteoarthritis of the Shoulder (WOOS) index was used to evaluate patient-reported outcome 12 months (10 to 14) post-operatively. The rates of revision were calculated from the revisions reported to the DSR up to December 2011 and by checking deaths with the Danish National Register of Persons. A complete questionnaire was returned by 688 patients (82.2%). The mean WOOS was 67 (0 to 100). A total of 63 hemiarthroplasties (7.5%) required revision; the cumulative five-year rate of revision was 9.9%. Patients aged < 55 years had a statistically significant inferior WOOS score, which exceeded the minimal clinically important difference, compared with older patients (mean difference 14.2 (8.8; 95% CI 19.6; p < 0.001), but with no increased risk of revision. There was no significant difference in the mean WOOS or the risk of revision between designs of resurfacing hemiarthroplasty.

  4. Quality of life outcome measures using UW-QOL questionnaire v4 in early oral cancer/squamous cell cancer resections of the tongue and floor of mouth with reconstruction solely using local methods.

    PubMed

    Boyapati, Raghuram P; Shah, Ketan C; Flood, Valerie; Stassen, Leo F A

    2013-09-01

    Cancer treatment either by surgery alone or in a combination of surgery, radiotherapy±chemotherapy has significant consequences on the physical, mental, emotional and psychosocial wellbeing of the patient. Measurement of quality of life (QOL) is necessary to understand the patient's perception of their own treatment, as clinicians' views can be biased. Reconstruction of a cancerous defect with a free vascular flap is ideal in large, often composite defects, provided it is appropriate to the advanced stage and prognosis of the disease, medical condition of the patient, availability of surgical and financial resources and allows the prosthetic rehabilitation of the anatomic area. Using University of Washington Quality of life 4 questionnaire (UW-QOL4), we assessed the QOL of 38 patients, who underwent local surgical reconstructions after resection of T1/T2 tongue/floor of mouth squamous cell carcinoma defects. Objective assessment of speech and swallow function was also carried out using therapy outcome measure (TOM) scores by the speech and language therapy team (SALT) aiming to see the differences in the scores obtained in patients who underwent post-operative radiotherapy. Our study, conducted 6months after completion of all oncologic treatment for the primary disease, showed satisfactory levels of quality of life parameters with good function showing that local reconstructive methods are successful and may have benefits in the management of early oral cancers involving the tongue and floor of mouth. They are beneficial by providing a good quality in terms of function, by reducing the operating time, the surgical morbidity, simplifying post-operative care and thereby becoming an efficient, effective and a cost effective method.

  5. Borderline personality disorder: patterns of self-harm, reported childhood trauma and clinical outcome

    PubMed Central

    Milner, Rebecca; Gavin, Victoria; Levita, Liat

    2015-01-01

    Summary Consecutive admissions of 214 women with borderline personality disorder were investigated for patterns of specific forms of self-harm and reported developmental experiences. Systematic examination of clinical notes found that 75% had previously reported a history of childhood sexual abuse. These women were more likely to self-harm, and in specific ways that may reflect their past experiences. Despite this, treatment within a dialectical behaviour therapy-informed therapeutic community leads to relatively greater clinical gains than for those without a reported sexual abuse trauma history. Notably, greater behavioural and self-reported distress and dissociation were not found to predict poor clinical outcome. Declaration of interest None. Copyright and usage © The Royal College of Psychiatrists 2015. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence. PMID:27703718

  6. The MPC&A Questionnaire

    SciTech Connect

    Powell, Danny H; Elwood Jr, Robert H

    2011-01-01

    The questionnaire is the instrument used for recording performance data on the nuclear material protection, control, and accountability (MPC&A) system at a nuclear facility. The performance information provides a basis for evaluating the effectiveness of the MPC&A system. The goal for the questionnaire is to provide an accurate representation of the performance of the MPC&A system as it currently exists in the facility. Performance grades for all basic MPC&A functions should realistically reflect the actual level of performance at the time the survey is conducted. The questionnaire was developed after testing and benchmarking the material control and accountability (MC&A) system effectiveness tool (MSET) in the United States. The benchmarking exercise at the Idaho National Laboratory (INL) proved extremely valuable for improving the content and quality of the early versions of the questionnaire. Members of the INL benchmark team identified many areas of the questionnaire where questions should be clarified and areas where additional questions should be incorporated. The questionnaire addresses all elements of the MC&A system. Specific parts pertain to the foundation for the facility's overall MPC&A system, and other parts pertain to the specific functions of the operational MPC&A system. The questionnaire includes performance metrics for each of the basic functions or tasks performed in the operational MPC&A system. All of those basic functions or tasks are represented as basic events in the MPC&A fault tree. Performance metrics are to be used during completion of the questionnaire to report what is actually being done in relation to what should be done in the performance of MPC&A functions.

  7. Preferred reporting items for studies mapping onto preference-based outcome measures: The MAPS statement.

    PubMed

    Petrou, Stavros; Rivero-Arias, Oliver; Dakin, Helen; Longworth, Louise; Oppe, Mark; Froud, Robert; Gray, Alastair

    2015-08-01

    'Mapping' onto generic preference-based outcome measures is increasingly being used as a means of generating health utilities for use within health economic evaluations. Despite publication of technical guides for the conduct of mapping research, guidance for the reporting of mapping studies is currently lacking. The MAPS (MApping onto Preference-based measures reporting Standards) statement is a new checklist, which aims to promote complete and transparent reporting of mapping studies. The primary audiences for the MAPS statement are researchers reporting mapping studies, the funders of the research, and peer reviewers and editors involved in assessing mapping studies for publication.A de novo list of 29 candidate reporting items and accompanying explanations was created by a working group comprised of six health economists and one Delphi methodologist. Following a two-round, modified Delphi survey with representatives from academia, consultancy, health technology assessment agencies and the biomedical journal editorial community, a final set of 23 items deemed essential for transparent reporting, and accompanying explanations, was developed. The items are contained in a user friendly 23 item checklist. They are presented numerically and categorised within six sections, namely: (i) title and abstract; (ii) introduction; (iii) methods; (iv) results; (v) discussion; and (vi) other. The MAPS statement is best applied in conjunction with the accompanying MAPS explanation and elaboration document.It is anticipated that the MAPS statement will improve the clarity, transparency and completeness of reporting of mapping studies. To facilitate dissemination and uptake, the MAPS statement is being co-published by eight health economics and quality of life journals, and broader endorsement is encouraged. The MAPS working group plans to assess the need for an update of the reporting checklist in five years' time.This statement was published jointly in Applied Health Economics

  8. Autonomic function, as self-reported on the SCOPA-autonomic questionnaire, is normal in essential tremor but not in Parkinson’s disease

    PubMed Central

    Damian, Anne; Adler, Charles H.; Hentz, Joseph G.; Shill, Holly A.; Caviness, John N.; Sabbagh, Marwan N.; Evidente, Virgilio G.H.; Beach, Thomas G.; Driver-Dunckley, Erika

    2013-01-01

    Objective To compare autonomic function of subjects with Parkinson’s disease (PD) and essential tremor (ET) relative to controls. Background It has been reported that patients with PD have autonomic dysfunction while no literature exists regarding autonomic function in ET. Methods Subjects with PD, ET, and controls had autonomic function measured using the SCOPA-Autonomic questionnaire, with the total and domain scores transformed to a scale of 0–100 points. Results 62 subjects with PD, 84 with ET, and 291 controls were included. Women were more prevalent in control (69%) compared to PD (44%) and ET (44%) groups, and mean age was significantly younger in PD (73 yrs) and older in ET (83) compared to controls (81). The mean SCOPA-Aut Total score in PD was significantly higher than controls, with no difference in ET. No autonomic dysfunction was found in any domain in ET but in PD there were significant abnormalities in gastrointestinal, cardiovascular, urinary, and thermoregulatory domains. Individual question data revealed a significantly higher percentage of subjects with dysfunction on 11/23 questions in the PD group but only 1 question (sialorrhea) in the ET group compared with controls. Conclusion Autonomic scores, particularly gastrointestinal, cardiovascular, urinary, and thermoregulatory were increased in patients with PD, as assessed by SCOPA-Aut. Patients with ET did not exhibit autonomic dysfunction, with the exception of sialorrhea. PMID:22771283

  9. Academic Training of Medical Students in Transfusion Medicine, Hemotherapy, and Hemostasis: Results of a Questionnaire-Based Status Report in Germany

    PubMed Central

    Scharf, Rüdiger E.; Burger, Reinhard

    2014-01-01

    Summary Background As a consequence of the German Transfusion Act and the corresponding Hemotherapeutic Guidelines of the German Medical Association, the National Advisory Committee Blood approved a recommendation (votum 29) in 2003 to specify students’ training in transfusion medicine, hemotherapy, and hemostasis. The objective of this study was to assess the current status of teaching in these fields. Methods A questionnaire-based evaluation was performed at the medical schools in Germany (n = 34). Responses were analyzed by descriptive criteria, except for weekly semester hours of teaching. Results Responses were obtained from 30 medical faculties (88%). Among them, 18 had conducted votum 29 (12 ‘completely’, 6 ‘essentially’), while 7 had done so only ‘in part’ and 5 ‘not at all’. 13 of 30 sites (43%) reported that no faculty-related curriculum in transfusion medicine and hemostasis (hemotherapy) exists. At 28 of 30 medical schools (93%), teaching in transfusion medicine, hemotherapy, and hemostasis is integrated into cross-curricular topics of interdisciplinary programs, including lectures. The corresponding semester hours of teaching per week ranged from 0.5 to 12 h/week. Conclusion Votum 29 is incompletely established. Consequently, academic teaching in transfusion medicine, hemotherapy, and hemostasis requires structural and conceptual improvement to fulfill legal specifications and regulatory constraints. PMID:25254026

  10. State mandated public reporting and outcomes of percutaneous coronary intervention in the United States.

    PubMed

    Cavender, Matthew A; Joynt, Karen E; Parzynski, Craig S; Resnic, Frederick S; Rumsfeld, John S; Moscucci, Mauro; Masoudi, Frederick A; Curtis, Jeptha P; Peterson, Eric D; Gurm, Hitinder S

    2015-06-01

    Public reporting has been proposed as a strategy to improve health care quality. Percutaneous coronary interventions (PCIs) performed in the United States from July 1, 2009, to June 30, 2011, included in the CathPCI Registry were identified (n = 1,340,213). Patient characteristics and predicted and observed in-hospital mortality were compared between patients treated with PCI in states with mandated public reporting (Massachusetts, New York, Pennsylvania) and states without mandated public reporting. Most PCIs occurred in states without mandatory public reporting (88%, n = 1,184,544). Relative to patients treated in nonpublic reporting states, those who underwent PCI in public reporting states had similar predicted in-hospital mortality (1.39% vs 1.37%, p = 0.17) but lower observed in-hospital mortality (1.19% vs 1.41%, adjusted odds ratio [ORadj] 0.80; 95% confidence interval [CI] 0.74, 0.88; p <0.001). In patients for whom outcomes were available at 180 days, the differences in mortality persisted (4.6% vs 5.4%, ORadj 0.85, 95% CI 0.79 to 0.92, p <0.001), whereas there was no difference in myocardial infarction (ORadj 0.97, 95% CI 0.89 to 1.07) or revascularization (ORadj 1.05, 95% CI 0.92 to 1.20). Hospital readmissions were increased at 180 days in patients who underwent PCI in public reporting states (ORadj 1.08, 95% CI 1.03 to 1.12, p = 0.001). In conclusion, patients who underwent PCI in states with mandated public reporting of outcomes had similar predicted risks but significantly lower observed risks of death during hospitalization and in the 6 months after PCI. These findings support considering public reporting as a potential strategy for improving outcomes of patients who underwent PCI although further studies are warranted to delineate the reasons for these differences.

  11. [Tuberculosis annual report 2009 --series 10. Treatment outcome and TB deaths].

    PubMed

    2012-05-01

    Evaluation of the treatment outcome by the cohort analysis method is an important part of tuberculosis (TB) control. In the Japanese TB surveillance system, the treatment outcome is automatically classified by computer according to a pre-set algorithm, so the treatment outcome is evaluated very rigidly. In the case of new sputum smear positive pulmonary TB cases (n = 8,999) newly notified in 2008, the patients' treatment outcomes based on the annual report 2009 database were as follows: "success," which combined "cured" and "completed," was 47.7%, "died" was 19.1%, "failed" was 1.1%, "defaulted" was 3.8%, "transferred out" was 2.8%, "on treatment after 12 months" was 11.8% and "not evaluated" was 13.6%. In addition to evaluation of the treatment outcome by the cohort method, the proportion of deaths was observed among all forms of TB patients (n = 24,571) who were newly registered in 2008. In total, 17.3% of all forms of TB cases died within one year after the beginning of treatment. The proportion corresponding to this was 23.7% for new sputum smear positive pulmonary TB and 23.5% for re-treatment sputum smear positive pulmonary TB. Among the new sputum smear positive pulmonary TB patients (n = 2,136) who died within one year after the beginning of treatment, 37.0% of them died within one month after the beginning of treatment, 51.6% died within two months and 61.9% died within three months.

  12. Joint modeling of multiple longitudinal patient-reported outcomes and survival

    PubMed Central

    Hatfield, Laura A.; Boye, Mark E.; Carlin, Bradley P.

    2011-01-01

    Researchers often include patient-reported outcomes (PROs) in Phase III clinical trials to demonstrate the value of treatment from the patient’s perspective. These data are collected as longitudinal repeated measures and are often censored by occurrence of a clinical event that defines a survival time. Hierarchical Bayesian models having latent individual-level trajectories provide a flexible approach to modeling such multiple outcome types simultaneously. We consider the case of many zeros in the longitudinal data motivating a mixture model, and demonstrate several approaches to modeling multiple longitudinal PROs with survival in a cancer clinical trial. These joint models may enhance Phase III analyses and better inform health care decision makers. PMID:21830926

  13. Physician Enabling Skills Questionnaire

    PubMed Central

    Hudon, Catherine; Lambert, Mireille; Almirall, José

    2015-01-01

    Abstract Objective To evaluate the reliability and validity of the newly developed Physician Enabling Skills Questionnaire (PESQ) by assessing its internal consistency, test-retest reliability, concurrent validity with patient-centred care, and predictive validity with patient activation and patient enablement. Design Validation study. Setting Saguenay, Que. Participants One hundred patients with at least 1 chronic disease who presented in a waiting room of a regional health centre family medicine unit. Main outcome measures Family physicians’ enabling skills, measured with the PESQ at 2 points in time (ie, while in the waiting room at the family medicine unit and 2 weeks later through a mail survey); patient-centred care, assessed with the Patient Perception of Patient-Centredness instrument; patient activation, assessed with the Patient Activation Measure; and patient enablement, assessed with the Patient Enablement Instrument. Results The internal consistency of the 6 subscales of the PESQ was adequate (Cronbach α = .69 to .92). The test-retest reliability was very good (r = 0.90; 95% CI 0.84 to 0.93). Concurrent validity with the Patient Perception of Patient-Centredness instrument was good (r = −0.67; 95% CI −0.78 to −0.53; P < .001). The PESQ accounts for 11% of the total variance with the Patient Activation Measure (r2 = 0.11; P = .002) and 19% of the variance with the Patient Enablement Instrument (r2 = 0.19; P < .001). Conclusion The newly developed PESQ presents good psychometric properties, allowing for its use in practice and research. PMID:26889507

  14. Neurocognitive and Patient-Reported Outcomes in Adult Survivors of Childhood Osteosarcoma

    PubMed Central

    Edelmann, Michelle N.; Daryani, Vinay M.; Bishop, Michael W.; Liu, Wei; Brinkman, Tara M.; Stewart, Clinton F.; Mulrooney, Daniel A.; Kimberg, Cara; Ness, Kirsten K.; Cheung, Yin Ting; Srivastava, Deo Kumar; Robison, Leslie L.; Hudson, Melissa M.; Krull, Kevin R.

    2015-01-01

    Importance This study provides the first objective data documenting neurocognitive impairment in long-term survivors of childhood osteosarcoma. Objective To examine neurocognitive, neurobehavioral, emotional and quality of life outcomes in long-term survivors of childhood osteosarcoma treated with intravenous high-dose methotrexate. Design Cross-sectional cohort study, with prospective treatment and chronic health predictors. Outcome data was collected from June 2008 to August 2014. Setting Academic research hospital. Participants Survivors of osteosarcoma (n=80; mean [SD] age = 38.9 [7.6] years; time since diagnosis = 24.7 [6.6] years; 42% female) recruited from the St. Jude Lifetime Cohort Study and compared to community controls (n=39; age = 39.03 [11.71] years; 56.4% female). Main Outcome Measures Objective tests of neurocognitive function. Subjective report of neurobehavioral symptoms, emotional distress and quality of life. Within survivors, outcomes were examined in relation to pharmacokinetic indices of methotrexate exposure and current chronic health conditions, which were assessed through medical examination and coded according to Common Terminology Criteria for Adverse Events v4.03. Results Compared to community controls, survivors demonstrated lower reading (p=0.012), attention (p=0.002), memory (p=0.019), processing speed (p<0.001) and executive function (p=0.006). Survivors also fell below national norms on these outcomes. Results of pharmacokinetic analysis showed high-dose methotrexate maximum plasma concentration, median clearance, and median/cumulative exposure were not associated with neurocognitive outcomes. Any grade 3 or 4 Common Terminology Criteria for Adverse Events cardiac, pulmonary or endocrine condition was associated with poorer memory (p=0.006) and slower processing speed (p=0.002). Survivor-reported poor general health was associated with decreased sustained attention (p=0.05) and processing speed (p=0.006). Conclusions Long

  15. Psychometric properties of carer-reported outcome measures in palliative care: A systematic review

    PubMed Central

    Michels, Charlotte TJ; Boulton, Mary; Adams, Astrid; Wee, Bee; Peters, Michele

    2016-01-01

    Background: Informal carers face many challenges in caring for patients with palliative care needs. Selecting suitable valid and reliable outcome measures to determine the impact of caring and carers’ outcomes is a common problem. Aim: To identify outcome measures used for informal carers looking after patients with palliative care needs, and to evaluate the measures’ psychometric properties. Design: A systematic review was conducted. The studies identified were evaluated by independent reviewers (C.T.J.M., M.B., M.P.). Data regarding study characteristics and psychometric properties of the measures were extracted and evaluated. Good psychometric properties indicate a high-quality measure. Data sources: The search was conducted, unrestricted to publication year, in the following electronic databases: Applied Social Sciences Index and Abstracts, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library, EMBASE, PubMed, PsycINFO, Social Sciences Citation Index and Sociological Abstracts. Results: Our systematic search revealed 4505 potential relevant studies, of which 112 studies met the inclusion criteria using 38 carer measures for informal carers of patients with palliative care needs. Psychometric properties were reported in only 46% (n = 52) of the studies, in relation to 24 measures. Where psychometric data were reported, the focus was mainly on internal consistency (n = 45, 87%), construct validity (n = 27, 52%) and/or reliability (n = 14, 27%). Of these, 24 measures, only four (17%) had been formally validated in informal carers in palliative care. Conclusion: A broad range of outcome measures have been used for informal carers of patients with palliative care needs. Little formal psychometric testing has been undertaken. Furthermore, development and refinement of measures in this field is required. PMID:26407683

  16. Life after prostate cancer diagnosis: protocol for a UK-wide patient-reported outcomes study

    PubMed Central

    Downing, Amy; Wright, Penny; Wagland, Richard; Watson, Eila; Kearney, Therese; Mottram, Rebecca; Allen, Majorie; Cairnduff, Victoria; McSorley, Oonagh; Butcher, Hugh; Hounsome, Luke; Donnelly, Conan; Selby, Peter; Kind, Paul; Cross, William; Catto, James W H; Huws, Dyfed; Brewster, David H; McNair, Emma; Matheson, Lauren; Rivas, Carol; Nayoan, Johana; Horton, Mike; Corner, Jessica; Verne, Julia; Gavin, Anna; Glaser, Adam W

    2016-01-01

    Background Prostate cancer and its treatment may impact physically, psychologically and socially; affecting the health-related quality of life of men and their partners/spouses. The Life After Prostate Cancer Diagnosis (LAPCD) study is a UK-wide patient-reported outcomes study which will generate information to improve the health and well-being of men with prostate cancer. Methods and analysis Postal surveys will be sent to prostate cancer survivors (18–42 months postdiagnosis) in all 4 UK countries (n=∼70 000). Eligible men will be identified and/or verified through cancer registration systems. Men will be surveyed twice, 12 months apart, to explore changes in outcomes over time. Second, separate cohorts will be surveyed once and the design will include evaluation of the acceptability of online survey tools. A comprehensive patient-reported outcome measure has been developed using generic and specific instruments with proven psychometric properties and relevance in national and international studies. The outcome data will be linked with administrative health data (eg, treatment information from hospital data). To ensure detailed understanding of issues of importance, qualitative interviews will be undertaken with a sample of men who complete the survey across the UK (n=∼150) along with a small number of partners/spouses (n=∼30). Ethics and dissemination The study has received the following approvals: Newcastle and North Tyneside 1 Research Ethics Committee (15/NE/0036), Health Research Authority Confidentiality Advisory Group (15/CAG/0110), NHS Scotland Public Benefit and Privacy Panel (0516-0364), Office of Research Ethics Northern Ireland (16/NI/0073) and NHS R&D approval from Wales, Scotland and Northern Ireland. Using traditional and innovative methods, the results will be made available to men and their partners/spouses, the funders, the NHS, social care, voluntary sector organisations and other researchers. PMID:27927667

  17. Similar patient-reported outcomes and performance after total knee arthroplasty with or without patellar resurfacing

    PubMed Central

    Ali, Abdulemir; Lindstrand, Anders; Nilsdotter, Anna; Sundberg, Martin

    2016-01-01

    Background and purpose Knee pain after total knee arthroplasty (TKA) is not uncommon. Patellar retention in TKA is one cause of postoperative knee pain, and may lead to secondary addition of a patellar component. Patellar resurfacing in TKA is controversial. Its use ranges from 2% to 90% worldwide. In this randomized study, we compared the outcome after patellar resurfacing and after no resurfacing. Patients and methods We performed a prospective, randomized study of 74 patients with primary osteoarthritis who underwent a Triathlon CR TKA. The patients were randomized to either patellar resurfacing or no resurfacing. They filled out the VAS pain score and KOOS questionnaires preoperatively, and VAS pain, KOOS, and patient satisfaction 3, 12, and 72 months postoperatively. Physical performance tests were performed preoperatively and 3 months postoperatively. Results We found similar scores for VAS pain, patient satisfaction, and KOOS 5 subscales at 3, 12, and 72 months postoperatively in the 2 groups. Physical performance tests 3 months postoperatively were also similar in the 2 groups. No secondary resurfacing was performed in the group with no resurfacing during the first 72 months Interpretation Patellar resurfacing in primary Triathlon CR TKA is of no advantage regarding pain, physical performance, KOOS 5 subscales, or patient satisfaction compared to no resurfacing. None of the patients were reoperated with secondary addition of a patellar component within 6 years. According to these results, routine patellar resurfacing in primary Triathlon TKA appears to be unnecessary. PMID:27212102

  18. Assessment of identity development and identity diffusion in adolescence - Theoretical basis and psychometric properties of the self-report questionnaire AIDA

    PubMed Central

    2012-01-01

    Background In the continuing revision of Diagnostic and Statistical Manual (DSM-V) “identity” is integrated as a central diagnostic criterion for personality disorders (self-related personality functioning). According to Kernberg, identity diffusion is one of the core elements of borderline personality organization. As there is no elaborated self-rating inventory to assess identity development in healthy and disturbed adolescents, we developed the AIDA (Assessment of Identity Development in Adolescence) questionnaire to assess this complex dimension, varying from “Identity Integration” to “Identity Diffusion”, in a broad and substructured way and evaluated its psychometric properties in a mixed school and clinical sample. Methods Test construction was deductive, referring to psychodynamic as well as social-cognitive theories, and led to a special item pool, with consideration for clarity and ease of comprehension. Participants were 305 students aged 12–18 attending a public school and 52 adolescent psychiatric inpatients and outpatients with diagnoses of personality disorders (N = 20) or other mental disorders (N = 32). Convergent validity was evaluated by covariations with personality development (JTCI 12–18 R scales), criterion validity by differences in identity development (AIDA scales) between patients and controls. Results AIDA showed excellent total score (Diffusion: α = .94), scale (Discontinuity: α = .86; Incoherence: α = .92) and subscale (α = .73-.86) reliabilities. High levels of Discontinuity and Incoherence were associated with low levels in Self Directedness, an indicator of maladaptive personality functioning. Both AIDA scales were significantly different between PD-patients and controls with remarkable effect sizes (d) of 2.17 and 1.94 standard deviations. Conclusion AIDA is a reliable and valid instrument to assess normal and disturbed identity in adolescents. Studies for further validation and for

  19. Validity of patient-reported swallowing and speech outcomes in relation to objectively measured oral function among patients treated for oral or oropharyngeal cancer.

    PubMed

    Rinkel, R N P M; Verdonck-de Leeuw, I M; de Bree, R; Aaronson, N K; Leemans, C R

    2015-04-01

    The objective of this study was to test the construct validity of the patient-reported outcomes Swallowing Quality of Life Questionnaire (SWAL-QOL) and Speech Handicap Index (SHI) in relation to objectively measured oral function among patients treated for oral or oropharyngeal cancer. The study sample consisted of patients treated for oral or oropharyngeal cancer. Outcome measures were the SWAL-QOL and the SHI, and the Functional Rehabilitation Outcomes Grade (FROG), a test to measure oral and shoulder function. Spearman's rank correlation coefficient was used to test associations between the SHI and SWAL-QOL scales, and the FROG scales. During a study period of 3 months, 38 patients (21 males, 17 females; mean age 54 years) were included who visited the outpatient clinic for follow-up care 6-155 months after surgical treatment (n = 14) or combined surgery and radiotherapy (n = 24) for oral (n = 21) or oropharyngeal cancer (n = 17). Most SWAL-QOL and SHI scales (except the SWAL-QOL Fatigue scale) correlated significantly with one or more FROG oral function scales. None of the SWAL-QOL and SHI scales correlated significantly with the FROG shoulder function scale. These results support the construct validity of the SWAL-QOL and SHI questionnaires for assessing speech and swallowing problems in daily life that are moderately but significantly related to oral function. A multidimensional assessment protocol is recommended for use in clinical practice and for research purposes for measuring oral function and swallowing- and speech-related problems in daily life among head and neck cancer patients.

  20. The validity, reliability and normative scores of the parent, teacher and self report versions of the Strengths and Difficulties Questionnaire in China

    PubMed Central

    Du, Yasong; Kou, Jianhua; Coghill, David

    2008-01-01

    Background The Strengths and Difficulties Questionnaire (SDQ) has become one of the most widely used measurement tools in child and adolescent mental health work across the globe. The SDQ was originally developed and validated within the UK and whilst its reliability and validity have been replicated in several countries important cross cultural issues have been raised. We describe normative data, reliability and validity of the Chinese translation of the SDQ (parent, teacher and self report versions) in a large group of children from Shanghai. Methods The SDQ was administered to the parents and teachers of students from 12 of Shanghai's 19 districts, aged between 3 and 17 years old, and to those young people aged between 11 and 17 years. Retest data was collected from parents and teachers for 45 students six weeks later. Data was analysed to describe normative scores, bandings and cut-offs for normal, borderline and abnormal scores. Reliability was assessed from analyses of internal consistency, inter-rater agreement, and temporal stability. Structural validity, convergent and discriminant validity were assessed. Results Full parent and teacher data was available for 1965 subjects and self report data for 690 subjects. Normative data for this Chinese urban population with bandings and cut-offs for borderline and abnormal scores are described. Principle components analysis indicates partial agreement with the original five factored subscale structure however this appears to hold more strongly for the Prosocial Behaviour, Hyperactivity – Inattention and Emotional Symptoms subscales than for Conduct Problems and Peer Problems. Internal consistency as measured by Cronbach's α coefficient were generally low ranging between 0.30 and 0.83 with only parent and teacher Hyperactivity – Inattention and teacher Prosocial Behaviour subscales having α > 0.7. Inter-rater correlations were similar to those reported previously (range 0.23 – 0.49) whilst test retest

  1. Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias — An Updated Review

    PubMed Central

    Dwan, Kerry; Gamble, Carrol; Williamson, Paula R.; Kirkham, Jamie J.

    2013-01-01

    Background The increased use of meta-analysis in systematic reviews of healthcare interventions has highlighted several types of bias that can arise during the completion of a randomised controlled trial. Study publication bias and outcome reporting bias have been recognised as a potential threat to the validity of meta-analysis and can make the readily available evidence unreliable for decision making. Methodology/Principal Findings In this update, we review and summarise the evidence from cohort studies that have assessed study publication bias or outcome reporting bias in randomised controlled trials. Twenty studies were eligible of which four were newly identified in this update. Only two followed the cohort all the way through from protocol approval to information regarding publication of outcomes. Fifteen of the studies investigated study publication bias and five investigated outcome reporting bias. Three studies have found that statistically significant outcomes had a higher odds of being fully reported compared to non-significant outcomes (range of odds ratios: 2.2 to 4.7). In comparing trial publications to protocols, we found that 40–62% of studies had at least one primary outcome that was changed, introduced, or omitted. We decided not to undertake meta-analysis due to the differences between studies. Conclusions This update does not change the conclusions of the review in which 16 studies were included. Direct empirical evidence for the existence of study publication bias and outcome reporting bias is shown. There is strong evidence of an association between significant results and publication; studies that report positive or significant results are more likely to be published and outcomes that are statistically significant have higher odds of being fully reported. Publications have been found to be inconsistent with their protocols. Researchers need to be aware of the problems of both types of bias and efforts should be concentrated on improving the

  2. Comparison of self-reported quality of vision outcomes after myopic LASIK with two femtosecond lasers: a prospective, eye-to-eye study

    PubMed Central

    Sáles, Christopher S; Manche, Edward E

    2016-01-01

    Purpose To compare self-reported quality of vision (QoV) outcomes after myopic LASIK (laser-assisted in situ keratomileusis) with two femtosecond lasers. Design Prospective, randomized, eye-to-eye study. Methods Consecutive myopic patients were treated with wavefront-guided LASIK bilaterally. Eyes were randomized according to ocular dominance. The flap of one eye was made with the IntraLase FS 60 kHz femtosecond laser with a conventional 70° side-cut, and the flap of the fellow eye was made with the IntraLase iFS 150 kHz femtosecond laser with an inverted 130° side-cut. Patients completed the validated, Rasch-tested, linear-scaled 30-item QoV questionnaire preoperatively and at Months 1, 3, 6, and 12. Results The study enrolled 120 fellow eyes in 60 patients. None of the measured QoV parameters exhibited statistically significant differences between the groups preoperatively or at any postoperative time point. Conclusion Creating LASIK flaps with an inverted side-cut using a 150 kHz femtosecond laser and with a conventional 70° side-cut using a 60 kHz femtosecond laser resulted in no significant differences in self-reported QoV assessed by the QoV questionnaire. PMID:27621589

  3. Evidence of Deeper Learning Outcomes. Findings from the Study of Deeper Learning Opportunities and Outcomes: Report 3

    ERIC Educational Resources Information Center

    Zeiser, Kristina L.; Taylor, James; Rickles, Jordan; Garet, Michael S.; Segeritz, Michael

    2014-01-01

    The "Study of Deeper Learning: Opportunities and Outcomes"--funded by the William and Flora Hewlett Foundation--aimed to determine whether students attending high schools with a mature and at least moderately well implemented approach to promoting deeper learning actually experienced greater deeper learning opportunities and outcomes…

  4. Gaining the Patient Reported Outcomes Measurement Information System (PROMIS) Perspective in Chronic Kidney Disease: a Midwest Pediatric Nephrology Consortium study

    PubMed Central

    Selewski, David T.; Massengill, Susan F.; Troost, Jonathan P.; Wickman, Larysa; Messer, Kassandra L.; Herreshoff, Emily; Bowers, Corinna; Ferris, Maria E.; Mahan, John D.; Greenbaum, Larry A.; MacHardy, Jackie; Kapur, Gaurav; Chand, Deepa H.; Goebel, Jens; Barletta, Gina Marie; Geary, Denis; Kershaw, David B.; Pan, Cynthia G.; Gbadegesin, Rasheed; Hidalgo, Guillermo; Lane, Jerome C.; Leiser, Jeffrey D.; Song, Peter X.; Thissen, David; Liu, Yang; Gross, Heather E.; DeWalt, Darren A.; Gipson, Debbie S.

    2014-01-01

    Background and Objectives Chronic kidney disease is a persistent chronic health condition commonly seen in pediatric nephrology programs. Our study aims to evaluate the sensitivity of the Patient Reported Outcomes Measurement Information System (PROMIS) pediatric instrument to indicators of disease severity and activity in pediatric chronic kidney disease. Methods This cross sectional study included 233 children 8–17 years old with chronic kidney disease from 16 participating institutions in North America. Disease activity indicators, including hospitalization in the previous 6 months, edema, and number of medications consumed daily, as well as disease severity indicators of kidney function and coexisting medical conditions were captured. PROMIS domains, including depression, anxiety, social-peer relationships, pain interference, fatigue, mobility, and upper extremity function, were administered via web-based questionnaires. Absolute effect sizes (AES) were generated to demonstrate the impact of disease on domain scores. Four children were excluded because of missing GFR estimations. Results 221 of the 229 children included in the final analysis completed the entire PROMIS questionnaire. Unadjusted PROMIS domains were responsive to chronic kidney disease activity indicators and number of coexisting conditions. PROMIS domain scores were worse in the presence of recent hospitalizations (depression AES 0.33, anxiety AES 0.42, pain interference AES 0.46, fatigue AES 0.50, mobility AES 0.49), edema (depression AES 0.50, anxiety AES 0.60, pain interference AES 0.77, mobility AES 0.54) and coexisting medical conditions (social peer-relationships AES 0.66, fatigue AES 0.83, mobility AES 0.60, upper extremity function AES 0.48). Conclusions The PROMIS pediatric domains of depression, anxiety, social-peer relationships, pain interference, and mobility were sensitive to the clinical status of children with chronic kidney disease in this multi-center cross sectional study

  5. Patient-Reported Outcome Measures and Risk Factors in a Quality Registry: A Basis for More Patient-Centered Diabetes Care in Sweden

    PubMed Central

    Borg, Sixten; Palaszewski, Bo; Gerdtham, Ulf-G; Ödegaard, Fredrik; Roos, Pontus; Gudbjörnsdottir, Soffia

    2014-01-01

    Diabetes is one of the chronic diseases that constitute the greatest disease burden in the world. The Swedish National Diabetes Register is an essential part of the diabetes care system. Currently it mainly records clinical outcomes, but here we describe how it has started to collect patient-reported outcome measures, complementing the standard registry data on clinical outcomes as a basis for evaluating diabetes care. Our aims were to develop a questionnaire to measure patient abilities and judgments of their experience of diabetes care, to describe a Swedish diabetes patient sample in terms of their abilities, judgments, and risk factors, and to characterize groups of patients with a need for improvement. Patient abilities and judgments were estimated using item response theory. Analyzing them together with standard risk factors for diabetes comorbidities showed that the different types of data describe different aspects of a patient’s situation. These aspects occasionally overlap, but not in any particularly useful way. They both provide important information to decision makers, and neither is necessarily more relevant than the other. Both should therefore be considered, to achieve a more complete evaluation of diabetes care and to promote person-centered care. PMID:25431875

  6. Patient-reported outcome measures and risk factors in a quality registry: a basis for more patient-centered diabetes care in Sweden.

    PubMed

    Borg, Sixten; Palaszewski, Bo; Gerdtham, Ulf-G; Fredrik, Odegaard; Roos, Pontus; Gudbjörnsdottir, Soffia

    2014-11-26

    Diabetes is one of the chronic diseases that constitute the greatest disease burden in the world. The Swedish National Diabetes Register is an essential part of the diabetes care system. Currently it mainly records clinical outcomes, but here we describe how it has started to collect patient-reported outcome measures, complementing the standard registry data on clinical outcomes as a basis for evaluating diabetes care. Our aims were to develop a questionnaire to measure patient abilities and judgments of their experience of diabetes care, to describe a Swedish diabetes patient sample in terms of their abilities, judgments, and risk factors, and to characterize groups of patients with a need for improvement. Patient abilities and judgments were estimated using item response theory. Analyzing them together with standard risk factors for diabetes comorbidities showed that the different types of data describe different aspects of a patient's situation. These aspects occasionally overlap, but not in any particularly useful way. They both provide important information to decision makers, and neither is necessarily more relevant than the other. Both should therefore be considered, to achieve a more complete evaluation of diabetes care and to promote person-centered care.

  7. Challenges and Opportunities in Using Patient-reported Outcomes in Quality Measurement in Rheumatology.

    PubMed

    Wahl, Elizabeth R; Yazdany, Jinoos

    2016-05-01

    Use of patient-reported outcome measures (PROs) in rheumatology research is widespread, but use of PRO data to evaluate the quality of rheumatologic care delivered is less well established. This article reviews the use of PROs in assessing health care quality, and highlights challenges and opportunities specific to their use in rheumatology quality measurement. It first explores other countries' experiences collecting and evaluating national PRO data to assess quality of care. It describes the current use of PROs as quality measures in rheumatology, and frames an agenda for future work supporting development of meaningful quality measures based on PROs.

  8. Patient-reported outcomes, patient-reported information: from randomized controlled trials to the social web and beyond.

    PubMed

    Baldwin, Mike; Spong, Andrew; Doward, Lynda; Gnanasakthy, Ari

    2011-01-01

    Internet communication is developing. Social networking sites enable patients to publish and receive communications very easily. Many stakeholders, including patients, are using these media to find new ways to make sense of diseases, to find and discuss treatments, and to give support to patients and their caregivers. We argue for a new definition of patient-reported information (PRI), which differs from the usual patient-reported outcomes (PRO). These new emergent data from the social web have important implications for decision making, at both an individual and a population level. We discuss new emergent technologies that will help aggregate this information and discuss how this will be assessed alongside the use of PROs in randomized controlled trials and how these new emergent data will be one facet of changing the relationship between the various stakeholders in achieving better co-created health.

  9. Outcome of Assisted Reproductive Technology (ART) and Subsequent Self-Reported Life Satisfaction

    PubMed Central

    Kuivasaari-Pirinen, Paula; Koivumaa-Honkanen, Heli; Hippeläinen, Maritta; Raatikainen, Kaisa; Heinonen, Seppo

    2014-01-01

    Objective To compare life satisfaction between women with successful or unsuccessful outcome after assisted reproductive treatment (ART) by taking into account the time since the last ART. Design Cohort study. Setting Tertiary hospital. Patients A total of 987 consecutive women who had undergone ART during 1996–2007 were invited and altogether 505 women participated in the study. Interventions A postal enquiry with a life satisfaction scale. Main Outcome Measure Self-reported life satisfaction in respect to the time since the last ART. Results In general, women who achieved a live birth after ART had a significantly higher life satisfaction than those who had unsuccessful ART, especially when compared in the first three years. The difference disappeared in the time period of 6–9 years after ART. The unsuccessfully treated women who had a child by some other means before or after the unsuccessful ART had comparable life satisfaction with successfully treated women even earlier. Conclusions Even if unsuccessful ART outcome is associated with subsequent lower level of life satisfaction, it does not seem to threaten the long-term wellbeing. PMID:25393846

  10. Financial Hardship and Patient-Reported Outcomes after Hematopoietic Cell Transplantation.

    PubMed

    Abel, Gregory A; Albelda, Randy; Khera, Nandita; Hahn, Theresa; Salas Coronado, Diana Y; Odejide, Oreofe O; Bona, Kira; Tucker-Seeley, Reginald; Soiffer, Robert

    2016-08-01

    Although hematopoietic cell transplantation (HCT) is the only curative therapy for many advanced hematologic cancers, little is known about the financial hardship experienced by HCT patients nor the association of hardship with patient-reported outcomes. We mailed a 43-item survey to adult patients approximately 180 days after their first autologous or allogeneic HCT at 3 high-volume centers. We assessed decreases in household income; difficulty with HCT-related costs, such as need to relocate or travel; and 2 types of hardship: hardship_1 (reporting 1 or 2 of the following: dissatisfaction with present finances, difficulty meeting monthly bill payments, or not having enough money at the end of the month) and "hardship_2" (reporting all 3). Patient-reported stress was measured with the Perceived Stress Scale-4, and 7-point scales were provided for perceptions of overall quality of life (QOL) and health. In total, 325 of 499 surveys (65.1%) were received. The median days since HCT was 173; 47% underwent an allogeneic HCT, 60% were male, 51% were > 60 years old, and 92% were white. Overall, 46% reported income decline after HCT, 56% reported hardship_1, and 15% reported hardship_2. In multivariable models controlling for income, those reporting difficulty paying for HCT-related costs were more likely to report financial hardship (odds ratio, 6.9; 95% confidence interval, 3.8 to 12.3). Hardship_1 was associated with QOL below the median (odds ratio, 2.9; 95% confidence interval, 1.7 to 4.9), health status below the median (odds ratio, 2.2; 95% confidence interval, 1.3 to 3.6), and stress above the median (odds ratio, 2.1; 95% confidence interval, 1.3 to 3.5). In this sizable cohort of HCT patients, financial hardship was prevalent and associated with worse QOL and higher levels of perceived stress. Interventions to address patient financial hardship-especially those that ameliorate HCT-specific costs-are likely to improve patient-reported outcomes.

  11. Patient-reported outcomes instruments: bridging the gap between international copyright laws and common practice for developers and users--a case example.

    PubMed

    Anfray, Caroline

    2009-12-01

    Copyright laws are intended to protect the rights of authors in their literary, scientific, and artistic works. The recent controversy about the standardized version of the Asthma Quality of Life Questionnaire between Elizabeth Juniper and Eirini Grammatopoulou et al. is an example of the difficulties inherent to copyright faced by developers and users of patient-reported outcome (PRO) instruments. This brief communication presents the basics of international copyright laws (i.e., the Berne Convention), the facts behind the controversy, and our analysis of the case based on our experience as a distributing center of PRO instruments. We conclude that better communication between developers and users would prevent most unfortunate complications and misunderstandings.

  12. Utah Drug Use Questionnaire.

    ERIC Educational Resources Information Center

    Governor's Citizen Advisory Committee on Drugs, Salt Lake City, UT.

    This questionnaire assesses drug use practices in junior and senior high school students. The 21 multiple choice items pertain to drug use practices, use history, available of drugs, main reason for drug use, and demographic data. The questionnaire is untimed, group administered, and may be given by the classroom teacher in about 10 minutes. Item…

  13. Write Your Own Questionnaire

    ERIC Educational Resources Information Center

    Cook, David I.

    1975-01-01

    Contends that student evaluative questionnaires should be designed by instructors themselves to help improve their classroom performance and therefore should contain only questions that students are capable of answering objectively and not, for instance, questions about the relevancy of the course. Contains a sample questionnaire. (GH)

  14. Wesleyan University Student Questionnaire.

    ERIC Educational Resources Information Center

    Haagen, C. Hess

    This questionnaire assesses marijuana use practices in college students. The 30 items (multiple choice or free response) are concerned with personal and demographic data, marijuana smoking practices, use history, effects from smoking marijuana, present attitude toward the substance, and use of other drugs. The Questionnaire is untimed and…

  15. National cataract surgery survey 1997-8: a report of the results of the clinical outcomes

    PubMed Central

    Desai, P.; Minassian, D; Reidy, A.

    1999-01-01

    AIMS—A national survey of over 100 hospitals in the UK was carried out to collect routine clinical information on the outcomes of cataract surgery. The clinical outcomes of interest were: visual acuity at time of discharge from postoperative hospital follow up, visual acuity at time of final refraction; complications related to surgery occurring during the operation, within 48 hours of surgery, and within 3 months of surgery. In addition, information on age and comorbidity was obtained. This article reports on the findings of the experience of approximately 18 000 patients who had cataract surgery in the hospital eye service of the NHS.
RESULTS—Of those with no ocular comorbidity, 85% achieved a visual acuity of 6/12 or better on discharge from postoperative hospital follow up, while 65% of patients with a serious co-existing eye disease achieved this level of acuity at this time. At final refraction, 92% of patients without ocular comorbidity and 77% of patients with ocular comorbidity achieved 6/12 or better visual acuity. The following main risk indicators were associated with visual outcomes and complications related to surgery: age, other eye diseases, diabetes and stroke, type of surgical procedure, and grade of surgeon.
CONCLUSIONS—The acceptability of these findings could fruitfully be the subject of discussion within the ophthalmic community and hopefully issues arising out of the study can lead to research, especially in-depth studies of the outcomes of cataract surgery in those patients with co-existing serious eye conditions.

 PMID:10574810

  16. The Sedentary Time and Activity Reporting Questionnaire (STAR-Q): reliability and validity against doubly labeled water and 7-day activity diaries.

    PubMed

    Csizmadi, Ilona; Neilson, Heather K; Kopciuk, Karen A; Khandwala, Farah; Liu, Andrew; Friedenreich, Christine M; Yasui, Yutaka; Rabasa-Lhoret, Rémi; Bryant, Heather E; Lau, David C W; Robson, Paula J

    2014-08-15

    We determined measurement properties of the Sedentary Time and Activity Reporting Questionnaire (STAR-Q), which was designed to estimate past-month activity energy expenditure (AEE). STAR-Q validity and reliability were assessed in 102 adults in Alberta, Canada (2009-2011), who completed 14-day doubly labeled water (DLW) protocols, 7-day activity diaries on day 15, and the STAR-Q on day 14 and again at 3 and 6 months. Three-month reliability was substantial for total energy expenditure (TEE) and AEE (intraclass correlation coefficients of 0.84 and 0.73, respectively), while 6-month reliability was moderate. STAR-Q-derived TEE and AEE were moderately correlated with DLW estimates (Spearman's ρs of 0.53 and 0.40, respectively; P < 0.001), and on average, the STAR-Q overestimated TEE and AEE (median differences were 367 kcal/day and 293 kcal/day, respectively). Body mass index-, age-, sex-, and season-adjusted concordance correlation coefficients (CCCs) were 0.24 (95% confidence interval (CI): 0.07, 0.36) and 0.21 (95% CI: 0.11, 0.32) for STAR-Q-derived versus DLW-derived TEE and AEE, respectively. Agreement between the diaries and STAR-Q (metabolic equivalent-hours/day) was strongest for occupational sedentary time (adjusted CCC = 0.76, 95% CI: 0.64, 0.85) and overall strenuous activity (adjusted CCC = 0.64, 95% CI: 0.49, 0.76). The STAR-Q demonstrated substantial validity for estimating occupational sedentary time and strenuous activity and fair validity for ranking individuals by AEE.

  17. Patient-reported satisfaction and cosmesis outcomes following laparoscopic adrenalectomy: Laparoendoscopic single-site adrenalectomy vs. conventional laparoscopic adrenalectomy

    PubMed Central

    Inoue, Shogo; Ikeda, Kenichiro; Kobayashi, Kanao; Kajiwara, Mitsuru; Teishima, Jun; Matsubara, Akio

    2014-01-01

    Introduction: We evaluate patient-reported satisfaction and cosmesis of laparoendoscopic single-site adrenalectomy (LESS-A) in comparison with that of conventional laparoscopic adrenalectomy (CLA). Methods: A total of 19 and 104 patients who respectively underwent LESS-A and CLA between May 1996 and June 2011 were included in the study. Questionnaires inquiring about scar pain (0: not painful, 10: very painful), satisfaction (0: not satisfied, 10: very satisfied) and cosmesis (0: very unsightly, 10: very beautiful) on the basis of a visual analogue scale were sent to patients postoperatively. Results: The respondents consisted of 11 and 54 patients who underwent LESS-A and CLA, respectively. There was no significant inter-group difference in age, sex, affected side or body mass index. No significant differences were observed in operative time or estimated blood loss. There were also no significant differences in pain (0.67 vs. 0.57, p = 0.393), satisfaction (8.92 vs. 8.46, p = 0.453), or cosmesis score (8.58 vs. 8.00, p = 0.487) between the LESS-A and CLA groups overall. In female patients, the satisfaction score was significantly higher in the LESS-A group than in the CLA group (10.0 vs. 8.72, p = 0.049). In young patients (<50 years old), the satisfaction score was also significantly higher in the LESS-A group than in the CLA group (9.17 vs. 6.38, p = 0.036). Conclusions: Young patients and female patients who had received LESS-A adrenal surgery were more satisfied with the scar outcomes than were the young patients and female patients who had received CLA. We suggest that this patient subset most values the cosmetic benefits of LESS-A. PMID:24454596

  18. Self-reported parental exposure to pesticide during pregnancy and birth outcomes: the MecoExpo cohort study.

    PubMed

    Mayhoub, Flora; Berton, Thierry; Bach, Véronique; Tack, Karine; Deguines, Caroline; Floch-Barneaud, Adeline; Desmots, Sophie; Stéphan-Blanchard, Erwan; Chardon, Karen

    2014-01-01

    The MecoExpo study was performed in the Picardy region of northern France, in order to investigate the putative relationship between parental exposures to pesticides (as reported by the mother) on one hand and neonatal parameters on the other. The cohort comprised 993 mother-newborn pairs. Each mother completed a questionnaire that probed occupational, domestic, environmental and dietary sources of parental exposure to pesticides during her pregnancy. Multivariate regression analyses were then used to test for associations between the characteristics of parental pesticide exposure during pregnancy and the corresponding birth outcomes. Maternal occupational exposure was associated with an elevated risk of low birth weight (odds ratio (OR) [95% confidence interval]: 4.2 [1.2, 15.4]). Paternal occupational exposure to pesticides was associated with a lower than average gestational age at birth (-0.7 weeks; p = 0.0002) and an elevated risk of prematurity (OR: 3.7 [1.4, 9.7]). Levels of domestic exposure to veterinary antiparasitics and to pesticides for indoor plants were both associated with a low birth weight (-70 g; p = 0.02 and -160 g; p = 0.005, respectively). Babies born to women living in urban areas had a lower birth length and a higher risk of low birth length (-0.4 cm, p = 0.006 and OR: 2.9 [1.5, 5.5], respectively). The present study results mainly demonstrate a negative correlation between fetal development on one hand and parental occupational and domestic exposure to pesticides on the other. Our study highlights the need to perform a global and detailed screening of all potential physiological effects when assessing in utero exposure to pesticides.

  19. Self-Reported Parental Exposure to Pesticide during Pregnancy and Birth Outcomes: The MecoExpo Cohort Study

    PubMed Central

    Mayhoub, Flora; Berton, Thierry; Bach, Véronique; Tack, Karine; Deguines, Caroline; Floch-Barneaud, Adeline; Desmots, Sophie; Stéphan-Blanchard, Erwan; Chardon, Karen

    2014-01-01

    The MecoExpo study was performed in the Picardy region of northern France, in order to investigate the putative relationship between parental exposures to pesticides (as reported by the mother) on one hand and neonatal parameters on the other. The cohort comprised 993 mother-newborn pairs. Each mother completed a questionnaire that probed occupational, domestic, environmental and dietary sources of parental exposure to pesticides during her pregnancy. Multivariate regression analyses were then used to test for associations between the characteristics of parental pesticide exposure during pregnancy and the corresponding birth outcomes. Maternal occupational exposure was associated with an elevated risk of low birth weight (odds ratio (OR) [95% confidence interval]: 4.2 [1.2, 15.4]). Paternal occupational exposure to pesticides was associated with a lower than average gestational age at birth (−0.7 weeks; p = 0.0002) and an elevated risk of prematurity (OR: 3.7 [1.4, 9.7]). Levels of domestic exposure to veterinary antiparasitics and to pesticides for indoor plants were both associated with a low birth weight (−70 g; p = 0.02 and −160 g; p = 0.005, respectively). Babies born to women living in urban areas had a lower birth length and a higher risk of low birth length (−0.4 cm, p = 0.006 and OR: 2.9 [1.5, 5.5], respectively). The present study results mainly demonstrate a negative correlation between fetal development on one hand and parental occupational and domestic exposure to pesticides on the other. Our study highlights the need to perform a global and detailed screening of all potential physiological effects when assessing in utero exposure to pesticides. PMID:24949871

  20. Measuring Patient Safety in Primary Care: The Development and Validation of the “Patient Reported Experiences and Outcomes of Safety in Primary Care” (PREOS-PC)

    PubMed Central

    Ricci-Cabello, Ignacio; Avery, Anthony J.; Reeves, David; Kadam, Umesh T.; Valderas, Jose M.

    2016-01-01

    PURPOSE We set out to develop and validate a patient-reported instrument for measuring experiences and outcomes related to patient safety in primary care. METHOD The instrument was developed in a multistage process supported by an international expert panel and informed by a systematic review of instruments, a meta-synthesis of qualitative studies, 4 patient focus groups, 18 cognitive interviews, and a pilot study. The trial version of Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) covered 5 domains and 11 scales: practice activation (1 scale); patient activation (1 scale); experiences of patient safety events (1 scale); harm (6 scales); and general perceptions of patient safety (2 scales). The questionnaire was posted to 6,736 patients in 45 practices across England. We used “gold standard” psychometric methods to evaluate its acceptability, reliability, structural and construct validity, and ability to discriminate among practices. RESULTS 1,244 completed questionnaires (18.5%) were returned. Median item-specific response rate was 91.3% (interquartile range 28.0%). No major ceiling or floor effects were observed. All 6 multi-item scales showed high internal consistency (Cronbach’s α 0.75–0.96). Factor analysis, correlation between scales, and known group analyses generally supported structural and construct validity. The scales demonstrated a heterogeneous ability to discriminate between practices. The final version of PREOS-PC consisted of 5 domains, 8 scales, and 58 items. CONCLUSIONS PREOS-PC is a new multi-dimensional patient safety instrument for primary care developed with experts and patients. Initial testing shows its potential for use in primary care, and future developments will further address its use in actual clinical practice. PMID:27184996

  1. A Comparison of Transfer Student Outcomes at Temple, LaSalle, West Chester, Widener and Thomas Jefferson Universities: Institutional Research Report #55. CCP Student Transfer Outcomes at Widener University: Institutional Research Report #50. Former CCP Transfer Outcomes at Hahnemann University, 1987-88 School Year: In-Brief #57.

    ERIC Educational Resources Information Center

    Grosset, Jane

    Part of a series of reports on transfer research conducted by the Community College of Philadelphia (CCP), these three reports examine transfer outcomes among former CCP students who matriculated at four-year universities in Pennsylvania. The first report compares CCP transfer student outcomes at Temple, LaSalle, West Chester, Widener, and Thomas…

  2. A practical guide to surveys and questionnaires.

    PubMed

    Slattery, Eric L; Voelker, Courtney C J; Nussenbaum, Brian; Rich, Jason T; Paniello, Randal C; Neely, J Gail

    2011-06-01

    Surveys with questionnaires play a vital role in decision and policy making in society. Within medicine, including otolaryngology, surveys with questionnaires may be the only method for gathering data on rare or unusual events. In addition, questionnaires can be developed and validated to be used as outcome measures in clinical trials and other clinical research architecture. Consequently, it is fundamentally important that such tools be properly developed and validated. Just asking questions that have not gone through rigorous design and development may be misleading and unfair at best; at worst, they can result in under- or overtreatment and unnecessary expense. Furthermore, it is important that consumers of the data produced by these instruments understand the principles of questionnaire design to interpret results in an optimal and meaningful way. This article presents a practical guide for understanding the methodologies of survey and questionnaire design, including the concepts of validity and reliability, how surveys are administered and implemented, and, finally, biases and pitfalls of surveys.

  3. The Daily Activity Report (DAR) a Novel Measure of Functional Outcome for Serious Mental Illness

    PubMed Central

    Velligan, Dawn I.; Mintz, Jim; Sierra, Cynthia; Martin, Mona L.; Fredrick, Megan; Maglinte, Gregory A.; Corey-Lisle, Patricia K.

    2016-01-01

    The assessment of real-world functional outcomes in clinical trials for medications targeting negative symptoms and cognitive impairment is extremely important. We tested the psychometric properties of the Daily Activity Report (DAR), a novel assessment of productive daily activity. We administered the DAR and additional assessments of functional outcome, functional capacity, cognition and symptomatology to 50 individuals with schizophrenia at 2 time points, 1 month apart and to 25 healthy controls. The DAR records a person’s daily activity for 7 consecutive days based upon phone calls made 3 times a day. A total score and scores in 3 domains; instrumental activities (ie, independent living), social and work or school related activities are generated for the DAR. Inter-item consistency was high 0.89–0.94 for each domain and 0.88 overall. Test–retest reliability across 1 month for the total DAR score was 0.67, P < .0001. The total DAR score as well as scores for social activity and nondomestic work/school differed significantly between control and patient participants (P < .0001). DAR domain scores were associated with negative symptoms and functional outcomes, but the primary score related to these measures was the work/school dimension of the DAR. DAR scores were only weakly and nonsignificantly related to positive symptoms. This study provides preliminary support for the reliability and validity of the DAR using interviewer administration. The development of a patient reported version of the DAR using smart phone technology with automatic scoring is the next step. PMID:26712856

  4. Transparency and Public Reporting of Pediatric and Congenital Heart Surgery Outcomes in North America.

    PubMed

    Jacobs, Jeffrey P; Jacobs, Marshall L

    2016-01-01

    Health care is embarking on a new era of increased transparency. In January 2015, the Society of Thoracic Surgeons (STS) began to publicly report outcomes of pediatric and congenital cardiac surgery using the 2014 Society of Thoracic Surgeons Congenital Heart Surgery Database (STS CHSD) Mortality Risk Model. Because the 2014 STS CHSD Mortality Risk Model adjusts for procedural factors and patient-level factors, it is critical that centers are aware of the important impact of incomplete entry of data in the fields for patient-level factors. These factors are used to estimate expected mortality, and incomplete coding of these factors can lead to inaccurate assessment of case mix and estimation of expected mortality. In order to assure an accurate assessment of case mix and estimate of expected mortality, it is critical to assure accurate completion of the fields for patient factors, including preoperative factors. It is crucial to document variables such as whether the patient was preoperatively ventilated or had an important noncardiac congenital anatomic abnormality. The lack of entry of these variables will lead to an underestimation of expected mortality. The art and science of assessing outcomes of pediatric and congenital cardiac surgery continues to evolve. In the future, when models have been developed that encompass other outcomes in addition to mortality, pediatric and congenital cardiac surgical performance may be able to be assessed using a multidomain composite metric that incorporates both mortality and morbidity, adjusting for the operation performed and for patient-specific factors. It is our expectation that in the future, this information will also be publicly reported. In this era of increased transparency, the complete and accurate coding of both patient-level factors and procedure-level factors is critical.

  5. Quality of life as patient-reported outcomes: principles of assessment.

    PubMed

    Bullinger, Monika; Quitmann, Julia

    2014-06-01

    Assessing quality of life (QoL) as a patient-reported outcome in adult psychiatry poses challenges in terms of concepts, methods, and applications in research and practice. This review will outline conceptually the construct of QoL, its dimensionality, and its representation across patient groups. Methodological challenges are examined, along with principles of QoL instrument development and testing, as well as across cultures. Application of instruments in epidemiological, clinical health economics, and health services research is reviewed based on pertinent literature. Validated measures for depression, psychosis, and anxiety disorders are available in adult psychiatry, and are increasingly used in research. Still, targeted measures are lacking for many mental health conditions and only rarely are tools applied in the practice context. Progress has been made in the development of instruments that are now ready for implementation. The information to be gained is valuable for identifying patient-reported needs for and benefits of treatment.

  6. [The preliminary draft of the methodology report by the Patient-Centered Outcomes Research Institute].

    PubMed

    Schmiemann, Guido

    2012-01-01

    There is a mismatch between results of clinical trials and the needs of patients. The Patient-Centered Outcomes Research Institute (PCORI) in the US will commission research that supports patients and providers of care to make informed decisions. The preliminary draft of a methodology report presented by PCORI contains methodological standards which researchers will have to take into account when applying for funds from PCORI. An innovative instrument, the "Translation Tool" has been introduced to judge the best match between a specific research question and the corresponding methods. The "Translation Tool" structures the necessary trade-offs (e.g. between validity, patient-centered endpoints, timeliness, and resources) in a transparent manner. This article summarizes the development, structure and content of the methodology report. (As supplied by publisher).

  7. Patient reported outcome measures of quality of end-of-life care: A systematic review.

    PubMed

    Kearns, Tara; Cornally, Nicola; Molloy, William

    2017-02-01

    End-of-life (EoL) care(1) is increasingly used as a generic term in preference to palliative care or terminal care, particularly with reference to individuals with chronic disease, who are resident in community and long-term care (LTC) settings. This review evaluates studies based on patient reported outcome measures (PROMS) of quality of EoL care across all health-care settings. From 1041 citations, 12 studies were extracted by searches conducted in EBSCO, Scopus, Web of Science, PubMed, Cochrane, Open Grey and Google Scholar databases. At present, the evidence base for EoL care is founded on cancer care. This review highlights the paucity of studies that evaluate quality of EoL care for patients with chronic disease outside the established cancer-acute care paradigm, particularly in LTC. This review highlights the absence of any PROMs for the estimated 60% of patients in LTC with cognitive impairment. Patient-reported outcomes (PROs) are critical to understanding how EoL care services and practices affect patients' health and EoL experience. PROMs describe the quality of care from the patient's perspective and add balance to existing clinical or proxy-derived knowledge on the quality of care and services provided.

  8. The CONSORT Patient-Reported Outcome (PRO) extension: implications for clinical trials and practice

    PubMed Central

    2013-01-01

    To inform clinical guidelines and patient care we need high quality evidence on the relative benefits and harms of intervention. Patient reported outcome (PRO) data from clinical trials can “empower patients to make decisions based on their values” and “level the playing field between physician and patient”. While clinicians have a good understanding of the concept of health-related quality of life and other PROs, evidence suggests that many do not feel comfortable in using the data from trials to inform discussions with patients and clinical practice. This may in part reflect concerns over the integrity of the data and difficulties in interpreting the results arising from poor reporting. The new CONSORT PRO extension aims to improve the reporting of PROs in trials to facilitate the use of results to inform clinical practice and health policy. While the CONSORT PRO extension is an important first step in the process, we need broader engagement with the guidance to facilitate optimal reporting and maximize use of PRO data in a clinical setting. Endorsement by journal editors, authors and peer reviewers are crucial steps. Improved design, implementation and transparent reporting of PROs in clinical trials are necessary to provide high quality evidence to inform evidence synthesis and clinical practice guidelines. PMID:24168680

  9. Preferred reporting items for studies mapping onto preference-based outcome measures: The MAPS statement.

    PubMed

    Petrou, Stavros; Rivero-Arias, Oliver; Dakin, Helen; Longworth, Louise; Oppe, Mark; Froud, Robert; Gray, Alastair

    2015-01-01

    'Mapping' onto generic preference-based outcome measures is increasingly being used as a means of generating health utilities for use within health economic evaluations. Despite publication of technical guides for the conduct of mapping research, guidance for the reporting of mapping studies is currently lacking. The MAPS (MApping onto Preference-based measures reporting Standards) statement is a new checklist, which aims to promote complete and transparent reporting of mapping studies. The primary audiences for the MAPS statement are researchers reporting mapping studies, the funders of the research, and peer reviewers and editors involved in assessing mapping studies for publication. A de novo list of 29 candidate reporting items and accompanying explanations was created by a working group comprised of six health economists and one Delphi methodologist. Following a two-round, modified Delphi survey with representatives from academia, consultancy, health technology assessment agencies and the biomedical journal editorial community, a final set of 23 items deemed essential for transparent reporting, and accompanying explanations, was developed. The items are contained in a user friendly 23 item checklist. They are presented numerically and categorised within six sections, namely: (i) title and abstract; (ii) introduction; (iii) methods; (iv) results; (v) discussion; and (vi) other. The MAPS statement is best applied in conjunction with the accompanying MAPS explanation and elaboration document. It is anticipated that the MAPS statement will improve the clarity, transparency and completeness of reporting of mapping studies. To facilitate dissemination and uptake, the MAPS statement is being co-published by seven health economics and quality of life journals, and broader endorsement is encouraged. The MAPS working group plans to assess the need for an update of the reporting checklist in five years' time.

  10. Preferred Reporting Items for Studies Mapping onto Preference-Based Outcome Measures: The MAPS Statement.

    PubMed

    Petrou, Stavros; Rivero-Arias, Oliver; Dakin, Helen; Longworth, Louise; Oppe, Mark; Froud, Robert; Gray, Alastair

    2015-10-01

    'Mapping' onto generic preference-based outcome measures is increasingly being used as a means of generating health utilities for use within health economic evaluations. Despite the publication of technical guides for the conduct of mapping research, guidance for the reporting of mapping studies is currently lacking. The MAPS (MApping onto Preference-based measures reporting Standards) statement is a new checklist, which aims to promote complete and transparent reporting of mapping studies. The primary audiences for the MAPS statement are researchers reporting mapping studies, the funders of the research, and peer reviewers and editors involved in assessing mapping studies for publication. A de novo list of 29 candidate reporting items and accompanying explanations was created by a working group comprising six health economists and one Delphi methodologist. Following a two-round modified Delphi survey with representatives from academia, consultancy, health technology assessment agencies and the biomedical journal editorial community, a final set of 23 items deemed essential for transparent reporting, and accompanying explanations, was developed. The items are contained in a user-friendly 23-item checklist. They are presented numerically and categorised within six sections, namely: (1) title and abstract; (2) introduction; (3) methods; (4) results; (5) discussion; and (6) other. The MAPS statement is best applied in conjunction with the accompanying MAPS explanation and elaboration document. It is anticipated that the MAPS statement will improve the clarity, transparency and completeness of reporting of mapping studies. To facilitate dissemination and uptake, the MAPS statement is being co-published by seven health economics and quality-of-life journals, and broader endorsement is encouraged. The MAPS working group plans to assess the need for an update of the reporting checklist in 5 years' time.

  11. Current status and future perspectives of patient-reported outcome research in clinical trials for patients with breast cancer in Japan.

    PubMed

    Ohsumi, Shozo; Shimozuma, Kojiro

    2013-10-01

    The aim of healthcare providers is to help patients regain their health and/or maintain or increase their happiness. The quality of healthcare can be assessed objectively by using indices such as survival rates, but subjective assessment is sometimes more important than objective evaluation, because whether patients feel healthy or happy or not is their major concern. Quality of life (QOL) research is a typical approach to subjective assessment of health. Self-administered health-related QOL (HRQOL) questionnaires are used to obtain patient-reported outcome (PRO) data. PRO is defined by the US Food and Drug Administration (FDA) as any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else. PRO data are regarded as more accurate than clinician-rated ones in terms of assessing patients' symptoms and HRQOL. The Comprehensive Support Project for Health Outcome Research of the Public Health Research Foundation has conducted much PRO research in collaboration with the Comprehensive Support Project for Oncology Research, especially in randomized controlled trials (RCTs). Here, we review the results of PRO research in RCTs conducted in Japan and examine future perspectives in this field.

  12. Effect of Secukinumab on Patient‐Reported Outcomes in Patients With Active Ankylosing Spondylitis: A Phase III Randomized Trial (MEASURE 1)

    PubMed Central

    Dougados, Maxime; Baeten, Dominique L.; Cheng‐Chung Wei, James; Geusens, Piet; Readie, Aimee; Richards, Hanno B.; Martin, Ruvie; Porter, Brian

    2016-01-01

    Objective To evaluate the effect of secukinumab (interleukin‐17A inhibitor) on patient‐reported outcomes in patients with active ankylosing spondylitis (AS). Methods In this phase III study, 371 patients were randomized (1:1:1) to receive intravenous (IV) secukinumab 10 mg/kg at baseline and weeks 2 and 4 followed by subcutaneous (SC) secukinumab 150 mg every 4 weeks (IV→150 mg group), or SC secukinumab 75 mg every 4 weeks (IV→75 mg group), or placebo. Patient‐reported outcomes included the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI criteria for 50% improvement (BASDAI 50), Short Form 36 (SF‐36) physical component summary (PCS) score and mental component summary (MCS) score, Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire, Bath Ankylosing Spondylitis Functional Index (BASFI), EuroQol 5‐domain (EQ‐5D) questionnaire, Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT‐F), and Work Productivity and Activity Impairment–General Health questionnaire (WPAI‐GH). Results At week 16, secukinumab IV→150 mg or IV→75 mg was associated with statistically and clinically significant improvements from baseline versus placebo in the BASDAI (−2.3 for both regimens versus −0.6; P < 0.0001 and P < 0.001, respectively), SF‐36 PCS (5.6 for both regimens versus 1.0; P < 0.0001 and P < 0.001, respectively), and ASQoL (−3.6 for both regimens versus −1.0; P < 0.0001 and P < 0.001, respectively). Clinically significant improvements in the SF‐36 MCS, BASFI, EQ‐5D, and BASDAI 50 were observed with both secukinumab groups versus placebo at week 16; improvements were also observed in the FACIT‐F and WPAI‐GH. All improvements were sustained through week 52. Conclusion Our findings indicate that secukinumab provides significant and sustained improvements in patient‐reported disease activity and health‐related quality of life, and reduces functional impairment, fatigue, and

  13. Patient Expectations and Patient-Reported Outcomes in Surgery: A Systematic Review

    PubMed Central

    Waljee, Jennifer; McGlinn, Evan P.; Sears, Erika Davis; Chung, Kevin C.

    2014-01-01

    Background Recent events in healthcare reform have brought national attention to integrating patient experiences and expectations into quality metrics. Few studies have comprehensively evaluated the effect of patient expectations on patient-reported outcomes (PROs) following surgery. The purpose of this study is to systematically review the available literature describing the relationship between patient expectations and postoperative PROs. Methods We performed a search of the literature published prior to November 1, 2012. Articles were included in the review if 1) primary data were presented 2) patient expectations regarding a surgical procedure were measured 3) PROs were measured, and 4) the relationship between patient expectations and PROs was specifically examined. PROs were categorized into five subgroups: satisfaction, quality of life (QOL), disability, mood disorder, and pain. We examined each study to determine the relationship between patient expectations and PROs as well as study quality. Results From the initial literature search yielding 1,708 studies, 60 articles were included. Fulfillment of expectations was associated with improved PROs among 24 studies. Positive expectations were correlated with improved PROs for 28 (47%) studies, and poorer PROs for 9 (15%) studies. Eighteen studies reported that fulfillment of expectations was correlated with improved patient satisfaction, and 10 studies identified that positive expectations were correlated with improved postoperative QOL. Finally, patients with positive preoperative expectations reported less pain (8 studies) and disability (15 studies) compared with patients with negative preoperative expectations. Conclusions Patient expectations are inconsistently correlated with PROs following surgery, and there is no accepted method to capture perioperative expectations. Future efforts to rigorously measure expectations and explore their influence on postoperative outcomes can inform clinicians and policy

  14. Dual bronchodilation in COPD: lung function and patient-reported outcomes - a review.

    PubMed

    Price, David; Østrem, Anders; Thomas, Mike; Welte, Tobias

    2017-01-01

    Several fixed-dose combinations (FDCs) of long-acting bronchodilators (a long-acting muscarinic antagonist [LAMA] plus a long-acting β2-agonist [LABA]) are available for the treatment of COPD. Studies of these FDCs have demonstrated substantial improvements in lung function (forced expiratory volume in 1 second) in comparison with their respective constituent monocomponents. Improvements in patient-reported outcomes (PROs), such as symptoms and health status, as well as exacerbation rates, have been reported compared with a LABA or LAMA alone, but results are less consistent. The inconsistencies may in part be owing to differences in study design, methods used to assess study end points, and patient populations. Nevertheless, these observations tend to support an association between improvements in forced expiratory volume in 1 second and improvements in symptom-based outcomes. In order to assess the effects of FDCs on PROs and evaluate relationships between PROs and changes in lung function, we performed a systematic literature search of publications reporting randomized controlled trials of FDCs. Results of this literature search were independently assessed by two reviewers, with a third reviewer resolving any conflicting results. In total, 22 Phase III randomized controlled trials of FDC bronchodilators in COPD were identified, with an additional study including a post-literature search (ten for indacaterol-glycopyrronium once daily, eight for umeclidinium-vilanterol once daily, three for tiotropium-olodaterol once daily, and two for aclidinium-formoterol twice daily). Results from these studies demonstrated that the LAMA-LABA FDCs significantly improved lung function compared with their component monotherapies or other single-agent treatments. Furthermore, LABA-LAMA combinations also generally improved symptoms and health status versus monotherapies, although some discrepancies between lung function and PROs were observed. Overall, the safety profiles of the

  15. Dual bronchodilation in COPD: lung function and patient-reported outcomes – a review

    PubMed Central

    Price, David; Østrem, Anders; Thomas, Mike; Welte, Tobias

    2017-01-01

    Several fixed-dose combinations (FDCs) of long-acting bronchodilators (a long-acting muscarinic antagonist [LAMA] plus a long-acting β2-agonist [LABA]) are available for the treatment of COPD. Studies of these FDCs have demonstrated substantial improvements in lung function (forced expiratory volume in 1 second) in comparison with their respective constituent monocomponents. Improvements in patient-reported outcomes (PROs), such as symptoms and health status, as well as exacerbation rates, have been reported compared with a LABA or LAMA alone, but results are less consistent. The inconsistencies may in part be owing to differences in study design, methods used to assess study end points, and patient populations. Nevertheless, these observations tend to support an association between improvements in forced expiratory volume in 1 second and improvements in symptom-based outcomes. In order to assess the effects of FDCs on PROs and evaluate relationships between PROs and changes in lung function, we performed a systematic literature search of publications reporting randomized controlled trials of FDCs. Results of this literature search were independently assessed by two reviewers, with a third reviewer resolving any conflicting results. In total, 22 Phase III randomized controlled trials of FDC bronchodilators in COPD were identified, with an additional study including a post-literature search (ten for indacaterol–glycopyrronium once daily, eight for umeclidinium–vilanterol once daily, three for tiotropium–olodaterol once daily, and two for aclidinium–formoterol twice daily). Results from these studies demonstrated that the LAMA–LABA FDCs significantly improved lung function compared with their component monotherapies or other single-agent treatments. Furthermore, LABA–LAMA combinations also generally improved symptoms and health status versus monotherapies, although some discrepancies between lung function and PROs were observed. Overall, the safety

  16. The use of research questionnaires with hearing impaired adults: online vs. paper-and-pencil administration

    PubMed Central

    2012-01-01

    Background When evaluating hearing rehabilitation, it is reasonable to use self-report questionnaires as outcome measure. Questionnaires used in audiological research are developed and validated for the paper-and-pencil format. As computer and Internet use is increasing, standardized questionnaires used in the audiological context should be evaluated to determine the viability of the online administration format. The aim of this study was to compare administration of questionnaires online versus paper- and pencil of four standardised questionnaires used in hearing research and clinic. We included the Hearing Handicap Inventory for the Elderly (HHIE), the International Outcome Inventory for Hearing Aids (IOI-HA), Satisfaction with Amplification in Daily Life (SADL), and the Hospital Anxiety and Depression Scale (HADS). Methods A cross-over design was used by randomly letting the participants complete the questionnaires either online or on paper. After 3 weeks the participants filled out the same questionnaires again but in the other format. A total of 65 hearing-aid users were recruited from a hearing clinic to participate on a voluntary basis and of these 53 completed both versions of the questionnaires. Results A significant main effect of format was found on the HHIE (p < 0.001), with participants reporting higher scores on the online format than in the paper format. There was no interaction effect. For the other questionnaires were no significant main or interaction effects of format. Significant correlations between the two ways of presenting the measures was found for all questionnaires (p<0.05). The results from reliability tests showed Cronbachs α’s above .70 for all four questionnaires and differences in Cronbachs α between administration formats were negligible. Conclusions For three of the four included questionnaires the participants’ scores remained consistent across administrations and formats. For the fourth included questionnaire (HHIE) a

  17. Adverse Outcomes Among Homeless Adolescents and Young Adults Who Report a History of Traumatic Brain Injury

    PubMed Central

    Harpin, Scott B.; Grubenhoff, Joseph A.; Rivara, Frederick P.

    2014-01-01

    Objectives. We examined the prevalence of self-reported traumatic brain injury (TBI) among homeless young people and explored whether sociodemographic characteristics, mental health diagnoses, substance use, exposure to violence, or difficulties with activities of daily living (ADLs) were associated with TBI. Methods. We analyzed data from the Wilder Homelessness Study, in which participants were recruited in 2006 and 2009 from streets, shelters, and locations in Minnesota that provide services to homeless individuals. Participants completed 30-minute interviews to collect information about history of TBI, homelessness, health status, exposure to violence (e.g., childhood abuse, assault), and other aspects of functioning. Results. Of the 2732 participating adolescents and young adults, 43% reported a history of TBI. Participants with TBI became homeless at a younger age and were more likely to report mental health diagnoses, substance use, suicidality, victimization, and difficulties with ADLs. The majority of participants (51%) reported sustaining their first injury prior to becoming homeless or at the same age of their first homeless episode (10%). Conclusions. TBI occurs frequently among homeless young people and is a marker of adverse outcomes such as mental health difficulties, suicidal behavior, substance use, and victimization. PMID:25122029

  18. Clinical Outcome Assessments: Conceptual Foundation–Report of the ISPOR Clinical Outcomes Assessment – Emerging Good Practices for Outcomes Research Task Force DOES THIS HAVE TO BE LABLED AS PART 1

    PubMed Central

    Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald L; Marquis, Patrick; Vamvakas, Sprios; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan J; Burke, Laurie

    2015-01-01

    An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient’s health status. Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition. Most efficacy endpoints are based on specified clinical assessments of patients. When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs). COAs include any assessment that may be influenced by human choices, judgment, or motivation, COAs must be well-defined and possess adequate measurement properties in order to demonstrate (directly or indirectly) the benefits of a treatment. In contrast, a biomarker assessment is one that is subject to little, if any, patient motivational or rater judgmental influence. This is the first of two reports by the ISPOR Clinical Outcomes Assessment – Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles. The foundation provided in this report includes what it means to demonstrate a beneficial effect, how assessments of patients relate to the objective of showing a treatment’s benefit, and how these assessments are used in clinical trial endpoints. In addition, this report describes intrinsic attributes of patient assessments and clinical trial factors that can affect the properties of the measurements. These factors should be considered when developing or refining assessments. These considerations will aid investigators designing trials in their choice of using an existing assessment or developing a new outcome assessment. Although the focus of this report is in the development of a new COA to define endpoints in a clinical trial, these principles may be applied more generally. A critical element in appraising or developing a

  19. Comparing the validity of the self reporting questionnaire and the Afghan symptom checklist: dysphoria, aggression, and gender in transcultural assessment of mental health

    PubMed Central

    2014-01-01

    Background The relative performance of local and international assessment instruments is subject to ongoing discussion in transcultural research on mental health and psychosocial support. We examined the construct and external validity of two instruments, one developed for use in Afghanistan, the other developed by the World Health Organization for use in resource-poor settings. Methods We used data collected on 1003 Afghan adults (500 men, 503 women) randomly sampled at three sites in Afghanistan. We compared the 22-item Afghan Symptom Checklist (ASCL), a culturally-grounded assessment of psychosocial wellbeing, with Pashto and Dari versions of the 20-item Self-Reporting Questionnaire (SRQ-20). We derived subscales using exploratory and confirmatory factor analyses (EFA and CFA) and tested total and subscale scores for external validity with respect to lifetime trauma and household wealth using block model regressions. Results EFA suggested a three-factor structure for SRQ-20 - somatic complaints, negative affect, and emotional numbing - and a two-factor structure for ASCL - jigar khun (dysphoria) and aggression. Both factor models were supported by CFA in separate subsamples. Women had higher scores for each of the five subscales than men (p < 0.001), and larger bivariate associations with trauma (rs .24 to .29, and .10 to .19, women and men respectively) and household wealth (rs -.27 to -.39, and .05 to -.22, respectively). The three SRQ-20 subscales and the ASCL jigar khun subscale were equally associated with variance in trauma exposures. However, interactions between gender and jigar khun suggested that, relative to SRQ-20, the jigar khun subscale was more strongly associated with household wealth for women; similarly, gender interactions with aggression indicated that the aggression subscale was more strongly associated with trauma and wealth. Conclusions Two central elements of Afghan conceptualizations of mental distress - aggression and the syndrome

  20. Cosmetic Outcomes and Complications Reported by Patients Having Undergone Breast-Conserving Treatment

    SciTech Connect

    Hill-Kayser, Christine E.; Vachani, Carolyn; Hampshire, Margaret K.; Di Lullo, Gloria A.; Metz, James M.

    2012-07-01

    Purpose: Over the past 30 years, much work in treatment of breast cancer has contributed to improvement of cosmetic and functional outcomes. The goal of breast-conservation treatment (BCT) is avoidance of mastectomy through use of lumpectomy and adjuvant radiation. Modern data demonstrate 'excellent' or 'good' cosmesis in >90% of patients treated with BCT. Methods and Materials: Patient-reported data were gathered via a convenience sample frame from breast cancer survivors using a publically available, free, Internet-based tool for creation of survivorship care plans. During use of the tool, breast cancer survivors are queried as to the cosmetic appearance of the treated breast, as well as perceived late effects. All data have been maintained anonymously with internal review board approval. Results: Three hundred fifty-four breast cancer survivors having undergone BCT and voluntarily using this tool were queried with regard to breast cosmesis and perceived late effects. Median diagnosis age was 48 years, and median current age 52 years. 'Excellent' cosmesis was reported by 27% (n = 88), 'Good' by 44% (n = 144), 'Fair' by 24% (n = 81), and 'Poor' by 5% (n = 18). Of the queries posted to survivors after BCT, late effects most commonly reported were cognitive changes (62%); sexual concerns (52%); changes in texture and color of irradiated skin (48%); chronic pain, numbness, or tingling (35%); and loss of flexibility in the irradiated area (30%). Survivors also described osteopenia/osteoporosis (35%), cardiopulmonary problems (12%), and lymphedema (19%). Conclusions: This anonymous tool uses a convenience sample frame to gather patient reported assessments of cosmesis and complications after breast cancer. Among the BCT population, cosmetic assessment by survivors appears less likely to be 'excellent' or 'good' than would be expected, with 30% of BCT survivors reporting 'fair' or 'poor' cosmesis. Patient reported incidence of chronic pain, as well as cognitive and

  1. A QUESTIONNAIRE TO ASSESS THE RELEVANCE AND CREDIBILITY OF OBSERVATIONAL STUDIES TO INFORM HEALTH CARE DECISION MAKING: AN ISPOR-AMCP-NPC GOOD PRACTICE TASK FORCE REPORT

    PubMed Central

    Berger, Marc L; Martin, Bradley C; Husereau, Don; Worley, Karen; Allen, Dan; Yang, Winnie; Mullins, C. Daniel; Kahler, Kristijan; Quon, Nicole C.; Devine, Scott; Graham, John; Cannon, Eric; Crown, William

    2014-01-01

    Evidence-based healthcare decisions are best informed by comparisons of all relevant interventions used to treat conditions in specific patient populations. Observational studies are being performed to help fill evidence gaps. However, widespread adoption of evidence from observational studies has been limited due to a variety of factors, including the lack of consensus regarding accepted principles for their evaluation and interpretation. Two Task Forces were formed to develop questionnaires to assist decision makers in evaluating observational studies, with one Task Force addressing retrospective research and the other prospective research. The intent was to promote a structured approach to reduce the potential for subjective interpretation of evidence and drive consistency in decision-making. Separately developed questionnaires were combined into a single questionnaire consisting of 33 items. These were divided into two domains: relevance and credibility. Relevance addresses the extent to which findings, if accurate, apply to the setting of interest to the decision maker. Credibility addresses the extent to which the study findings accurately answer the study question. The questionnaire provides a guide for assessing the degree of confidence that should be placed from observational studies and promotes awareness of the subtleties involved in evaluating those. PMID:24636373

  2. Federal-State Environmental Programs: The State Perspective. A Compilation of Questionnaire Responses. Supplement to a Report to the Congress by the Comptroller General of the United States.

    ERIC Educational Resources Information Center

    Comptroller General of the U.S., Washington, DC.

    Summarized are responses to questionnaires prepared by the United States General Accounting Office (GAO) and mailed to state-level environmental agency administrators. Also included in this survey are state program directors responsible for administering the Clean Air Act; the Federal Insecticide, Fungicide and Rodenticide Act; the Clean Water…

  3. Tabular Summary of the Third Follow-Up Questionnaire Data. Volume 1 [and] Volume 2 [and] Volume 3 [and] Volume 4. Sponsored Report Series NCES 79-228.

    ERIC Educational Resources Information Center

    Peng, Samuel S.; And Others

    Tabular summaries of the 153 numerical responses to the Second Followup Questionnaire items of the National Longitudinal Study of the High School Class of 1972 are presented--20,872 individuals responded. These items summarize participants' educational experiences and occupational attainments from October 1973 to October 1974; continuing or…

  4. Applying Learning Strategy Questionnaires: Problems and Possibilities

    ERIC Educational Resources Information Center

    Schellings, Gonny

    2011-01-01

    This article discusses measuring learning strategies by means of questionnaires. In "multi-method" research, in which think-aloud measures are compared with questionnaires, low or moderate correlations are found. A conclusion often drawn is that learners are not able to verbally report on their learning activities. Alternative explanations concern…

  5. Comparison of CTT and Rasch-based approaches for the analysis of longitudinal Patient Reported Outcomes.

    PubMed

    Blanchin, Myriam; Hardouin, Jean-Benoit; Le Neel, Tanguy; Kubis, Gildas; Blanchard, Claire; Mirallié, Eric; Sébille, Véronique

    2011-04-15

    Health sciences frequently deal with Patient Reported Outcomes (PRO) data for the evaluation of concepts, in particular health-related quality of life, which cannot be directly measured and are often called latent variables. Two approaches are commonly used for the analysis of such data: Classical Test Theory (CTT) and Item Response Theory (IRT). Longitudinal data are often collected to analyze the evolution of an outcome over time. The most adequate strategy to analyze longitudinal latent variables, which can be either based on CTT or IRT models, remains to be identified. This strategy must take into account the latent characteristic of what PROs are intended to measure as well as the specificity of longitudinal designs. A simple and widely used IRT model is the Rasch model. The purpose of our study was to compare CTT and Rasch-based approaches to analyze longitudinal PRO data regarding type I error, power, and time effect estimation bias. Four methods were compared: the Score and Mixed models (SM) method based on the CTT approach, the Rasch and Mixed models (RM), the Plausible Values (PV), and the Longitudinal Rasch model (LRM) methods all based on the Rasch model. All methods have shown comparable results in terms of type I error, all close to 5 per cent. LRM and SM methods presented comparable power and unbiased time effect estimations, whereas RM and PV methods showed low power and biased time effect estimations. This suggests that RM and PV methods should be avoided to analyze longitudinal latent variables.

  6. Patient-Reported Outcomes Following Living Kidney Donation: A Single Center Experience.

    PubMed

    Rodrigue, James R; Vishnevsky, Tanya; Fleishman, Aaron; Brann, Tracy; Evenson, Amy R; Pavlakis, Martha; Mandelbrot, Didier A

    2015-09-01

    This article describes the development and implementation of an initiative at one transplant center to annually assess psychosocial outcomes of living kidney donors. The current analysis focuses on a cohort of adults (n = 208) who donated a kidney at BIDMC between September 2005 and August 2012, in which two post-donation annual assessments could be examined. One and two year post-donation surveys were returned by 59 % (n = 123) and 47 % (n = 98) of LKDs, respectively. Those who did not complete any survey were more likely to be younger (p = 0.001), minority race/ethnicity (p < 0.001), and uninsured at the time of donation (p = 0.01) compared to those who returned at least one of the two annual surveys. The majority of donors reported no adverse physical or psychosocial consequences of donation, high satisfaction with the donation experience, and no donation decision regret. However, a sizable minority of donors felt more pain intensity than expected and recovery time was much slower than expected, and experienced a clinically significant decline in vitality. We describe how these outcomes are used to inform clinical practice at our transplant center as well as highlight challenges in donor surveillance over time.

  7. Functional Outcome of Conservatively Treated Bilateral Neck of Femur Fracture in an Elderly: A Case Report

    PubMed Central

    2016-01-01

    Bilateral Neck of Femur (NOF) fractures is relatively rare. Surgery, either osteosynthesis or hemireplacement arthroplasty, is the mainstay of treatment. Significant complications are known to occur in such cases. In this case report, we present the functional outcome of a conservatively treated bilateral NOF fracture at one year, in a 93-year-old man. Our patient, a 93-year-old gentleman, sustained right side NOF fracture in May 2014 and left side NOF fracture in May 2015, both after trivial fall. He did not give consent for surgery considering high operative risk. Now, at one year follow-up he has no true or apparent limb length discrepancy. He is ambulant with walker, self reliant for toilet care and other personal needs. Harris hip score is 75.80 and 69.65 after 1 year from right and left NOF fracture respectively. In view of high mortality after surgery for NOF fracture in high risk patients or unavailability of resources, conservative treatment for bilateral NOF fracture can achieve satisfactory functional outcome in selected patients. PMID:28208960

  8. Introducing the Concept of the Minimally Important Difference to Determine a Clinically Relevant Change on Patient-Reported Outcome Measures in Patients with Intermittent Claudication

    SciTech Connect

    Conijn, Anne P.; Jonkers, Wilma; Rouwet, Ellen V.; Vahl, Anco C.; Reekers, Jim A.; Koelemay, Mark J. W.

    2015-10-15

    PurposeThe minimally important difference (MID) represents the smallest change in score on patient-reported outcome measures that is relevant to patients. The aim of this study was to introduce the MID for the Vascular Quality of Life Questionnaire (VascuQol) and the walking impairment questionnaire (WIQ) for patients with intermittent claudication (IC).MethodsIn this multicenter study, we recruited 294 patients with IC between July and October 2012. Patients completed the VascuQol, with scores ranging from 1 to 7 (worst to best), and the WIQ, with scores ranging from 0 to 1 (worst to best) at first visit and after 4 months follow-up. In addition, patients answered an anchor-question rating their health status compared to baseline, as being improved, unchanged, or deteriorated. The MID for improvement and deterioration was calculated by an anchor-based approach, and determined with the upper and lower limits of the 95 % confidence interval of the mean change of the group who had not changed according to the anchor-question.ResultsFor the MID analyses of the VascuQol and WIQ, 163 and 134 patients were included, respectively. The MID values for the VascuQol (mean baseline score 4.25) were 0.87 for improvement and 0.23 for deterioration. For the WIQ (mean baseline score 0.39), we found MID values of 0.11 and −0.03 for improvement and deterioration, respectively.ConclusionIn this study, we calculated the MID for the VascuQol and the WIQ. Applying these MID facilitates better interpretation of treatment outcomes and can help to set treatment goals for individual care.

  9. An introduction to patient-reported outcome measures (PROMs) in physiotherapy.

    PubMed

    Kyte, D G; Calvert, M; van der Wees, P J; ten Hove, R; Tolan, S; Hill, J C

    2015-06-01

    The use of patient-reported outcome measures (PROMs) is set to rise in physiotherapy. PROMs provide additional 'patient-centred' data which is unique in capturing the patient's own opinion on the impact of their disease or disorder, and its treatment, on their life. Thus, PROMs are increasingly used by clinicians to guide routine patient care, or for the purposes of audit, and are already firmly embedded in clinical research. This article seeks to summarise the key aspects of PROM use for physiotherapists, both in routine clinical practice and in the research setting, and highlights recent developments in the field. Generic and condition-specific PROMs are defined and examples of commonly used measures are provided. The selection of appropriate PROMs, and their effective use in the clinical and research settings is discussed. Finally, existing barriers to PROM use in practice are identified and recent physiotherapy PROM initiatives, led by the Royal Dutch Society for Physical Therapy are explored.

  10. Implementation of an ODM and HL7 Compliant Electronic Patient-Reported Outcome System.

    PubMed

    Soto-Rey, Iñaki; Dugas, Martin; Storck, Michael

    2016-01-01

    Interoperability is one of the biggest issues in health informatics despite of the huge effort invested to solve it. Clinical Data Interchange Standards Consortium (CDISC) and Health Level 7 (HL7) are two of the most recognized institutions working on this field. Several systems are becoming compliant with their standards; however, the process to accomplish it is not always straightforward. In this manuscript, we present the successful implementation of the CDISC ODM and HL7 import and export functions for "MoPat", a web-based multi-language electronic patient-reported outcomes system. The system has been evaluated and tested and is currently being used for clinical study and routine data collection, including more than 10.000 patient encounters.

  11. Reproductive outcomes in men with karyotype abnormalities: Case report and review of the literature

    PubMed Central

    Kohn, Taylor P.; Clavijo, Raul; Ramasamy, Ranjith; Hakky, Tariq; Candrashekar, Aravind; Lamb, Dolores J.; Lipshultz, Larry I.

    2015-01-01

    Reciprocal translocations of autosomal chromosomes are present in about 1/625 men, yet often there are no symptoms except primary infertility. Abnormal segregation during meiosis often produces sperm and subsequent embryos with unbalanced translocations that often ultimately result in spontaneous abortions. We report on a 37-year-old man and his 39-year-old wife who complained of primary infertility. Previous in vitro fertilization (IVF) had resulted in pregnancy, but two spontaneous abortions. Upon chromosomal testing, the man was diagnosed with a reciprocal translocation and his wife was diagnosed with mosaic Turner’s syndrome. Through testicular sperm extraction (TESE) and IVF with preimplantation genetic screening (PGS), they succeeded in having two healthy children. Since men with different karyotype abnormalities can have male infertility, we reviewed the literature and summarized the reproductive outcomes for men with both autosome and sex chromosomal karyotype abnormalities. PMID:26425238

  12. Measuring patient-reported outcomes: moving beyond misplaced common sense to hard science

    PubMed Central

    2011-01-01

    Interest in the patient's views of his or her illness and treatment has increased dramatically. However, our ability to appropriately measure such issues lags far behind the level of interest and need. Too often such measurement is considered to be a simple and trivial activity that merely requires the application of common sense. However, good quality measurement of patient-reported outcomes is a complex activity requiring considerable expertise and experience. This review considers the most important issues related to such measurement in the context of chronic disease and details how instruments should be developed, validated and adapted for use in additional languages. While there is often consensus on how best to undertake these activities, there is generally little evidence to support such accord. The present article questions these orthodox views and suggests alternative approaches that have been shown to be effective. PMID:21756344

  13. Patient-reported outcome measures: an on-line system empowering patient choice

    PubMed Central

    Wilson, J; Arshad, F; Nnamoko, N; Whiteman, A; Ring, J; Roy, B

    2014-01-01

    An innovative web-based system was developed to allow patient-reported outcome measures (PROMs) to be easily administered. Stakeholders guided the design and implementation. The software gives patients access to their current and previous scores. This pilot study focused on patients undergoing arthroscopic subacromial decompression, evaluated using the Oxford shoulder score (OSS). Patients showing good improvement in their OSS were offered the choice to return for routine follow-up clinic appointments, or continue rehabilitation, reassured by their improved score. Thirty-six of 117 patients were eligible. Thirty of these (83%) were opted to avoid further clinics. PROMs 2.0 can be used for any medical intervention with a validated PROM. Evolution and refinement is ongoing. Funding has been granted for 12 primary and secondary healthcare trusts to implement PROMs 2.0. Further work is needed to assess economic impact, patient views and satisfaction with the process. PMID:24013090

  14. Family reports of medically impaired drivers in Missouri: cognitive concerns and licensing outcomes.

    PubMed

    Meuser, Thomas M; Carr, David B; Unger, Elizabeth A; Ulfarsson, Gudmundur F

    2015-01-01

    This study investigated reasons why older adults (n=689) were reported to the Driver License Bureau, Missouri Department of Revenue, by family members as potentially unfit to drive with an emphasis on cognitive concerns and associated licensing outcomes. A total of 448 drivers were reported to have some cognitive issue; common symptoms included confusion, memory loss, and becoming lost while driving. Diagnostic labels (Alzheimer's disease (AD), cognitive impairment/dementia, brain injury/insult) were listed for 365 cases. A physician evaluation is required for license review. Of those with a diagnostic label, half (51%, n=187) failed to submit this evaluation and almost all were de-licensed immediately. Of those evaluated by a physician, diagnostic agreement between family members and physicians was high for specific conditions (100% for AD, 97% for acute brain injury), and less so for cognitive impairment/dementia (75%). This latter finding suggests that physicians and family members may understand cognitive symptoms differently. Whether cognitively impaired or not, few family reported drivers in this sample (∼2%) retained a valid license. Family members may be in the best position to recognize when medical-functional deficits impact on driving safety, and physicians and driver licensing authorities would do well to take their observations into account with respect to older driver fitness.

  15. Patient-Reported Outcome and Quality of Life Instruments Database (PROQOLID): Frequently asked questions

    PubMed Central

    Emery, Marie-Pierre; Perrier, Laure-Lou; Acquadro, Catherine

    2005-01-01

    The exponential development of Patient-Reported Outcomes (PRO) measures in clinical research has led to the creation of the Patient-Reported Outcome and Quality of Life Instruments Database (PROQOLID) to facilitate the selection process of PRO measures in clinical research. The project was initiated by Mapi Research Trust in Lyon, France. Initially called QOLID (Quality of Life Instruments Database), the project's purpose was to provide all those involved in health care evaluation with a comprehensive and unique source of information on PRO and HRQOL measures available through the Internet. PROQOLID currently describes more than 470 PRO instruments in a structured format. It is available in two levels, non-subscribers and subscribers, at . The first level is free of charge and contains 14 categories of basic useful information on the instruments (e.g. author, objective, original language, list of existing translations, etc.). The second level provides significantly more information about the instruments. It includes review copies of over 350 original instruments, 120 user manuals and 350 translations. Most are available in PDF format. This level is only accessible to annual subscribers. PROQOLID is updated in close collaboration with the instruments' authors on a regular basis. Fifty or more new instruments are added to the database annually. Today, all of the major pharmaceutical companies, prestigious institutions (such as the FDA, the NIH's National Cancer Institute, the U.S. Veterans Administration), dozens of universities, public institutions and researchers subscribe to PROQOLID on a yearly basis. More than 800 users per day routinely visit the database. PMID:15755325

  16. Development of the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scales

    PubMed Central

    Spiegel, Brennan M.R.; Hays, Ron D.; Bolus, Roger; Melmed, Gil Y.; Chang, Lin; Whitman, Cynthia; Khanna, Puja P.; Paz, Sylvia H.; Hays, Tonya; Reise, Steve; Khanna, Dinesh

    2014-01-01

    OBJECTIVES The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS®) is a standardized set of patient-reported outcomes (PROs) that cover physical, mental, and social health. The aim of this study was to develop the NIH PROMIS gastrointestinal (GI) symptom measures. METHODS We first conducted a systematic literature review to develop a broad conceptual model of GI symptoms. We complemented the review with 12 focus groups including 102 GI patients. We developed PROMIS items based on the literature and input from the focus groups followed by cognitive debriefing in 28 patients. We administered the items to diverse GI patients (irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), systemic sclerosis (SSc), and other common GI disorders) and a census-based US general population (GP) control sample. We created scales based on confirmatory factor analyses and item response theory modeling, and evaluated the scales for reliability and validity. RESULTS A total of 102 items were developed and administered to 865 patients with GI conditions and 1,177 GP participants. Factor analyses provided support for eight scales: gastroesophageal reflux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence/soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas/bloat/flatulence (12 items). The scales correlated significantly with both generic and disease-targeted legacy instruments, and demonstrate evidence of reliability. CONCLUSIONS Using the NIH PROMIS framework, we developed eight GI symptom scales that can now be used for clinical care and research across the full range of GI disorders. PMID:25199473

  17. Intraoperative medial pivot affects deep knee flexion angle and patient-reported outcomes after total knee arthroplasty.

    PubMed

    Nishio, Yusuke; Onodera, Tomohiro; Kasahara, Yasuhiko; Takahashi, Daisuke; Iwasaki, Norimasa; Majima, Tokifumi

    2014-04-01

    The aim of this study was to evaluate the relationship between clinical results including patient-reported outcomes and intraoperative knee kinematic patterns after total knee arthroplasty (TKA). A cross-sectional survey of forty consecutive medial osteoarthritis patients who had a primary TKA using a CT-based navigation system was conducted. Subjects were divided into two groups based on intraoperative kinematic patterns: a medial pivot group (n = 20) and a non-medial pivot group (n = 20). Subjective outcomes with the new Knee Society Score and clinical outcomes were evaluated. The functional activities, patient satisfaction and the knee flexion angle of the medial pivot group were significantly better than those of the non-medial pivot group. An intraoperative medial pivot pattern positively influences deep knee flexion and patient-reported outcomes.

  18. Validation of a questionnaire measuring the regulation of autonomic function

    PubMed Central

    Kröz, M; Feder, G; von Laue, HB; Zerm, R; Reif, M; Girke, M; Matthes, H; Gutenbrunner, C; Heckmann, C

    2008-01-01

    Background To broaden the range of outcomes that we can measure for patients undergoing treatment for oncological and other chronic conditions, we aimed to validate a questionnaire measuring self-reported autonomic regulation (aR), i.e. to characterise a subject's autonomic functioning by questions on sleeping and waking, vertigo, morningness-eveningness, thermoregulation, perspiration, bowel movements and digestion. Methods We administered the questionnaire to 440 participants (♀: N = 316, ♂: N = 124): 95 patients with breast cancer, 49 with colorectal cancer, 60 with diabetes mellitus, 39 with coronary heart disease, 28 with rheumatological conditions, 32 with Hashimoto's disease, 22 with multiple morbidities and 115 healthy people. We administered the questionnaire a second time to 50.2% of the participants. External convergence criteria included the German version of the Hospital Anxiety and Depression Scale (HADS-D), a short questionnaire on morningness-eveningness, the Herdecke Quality of Life Questionnaire (HLQ) and a short version questionnaire on self-regulation. Results A principal component analysis yielded a three dimensional 18-item inventory of aR. The subscales orthostatic-circulatory, rest/activity and digestive regulation had internal consistency (Cronbach-α: rα = 0.65 – 0.75) and test-retest reliability (rrt = 0.70 – 85). AR was negatively associated with anxiety, depression, and dysmenorrhoea but positively correlated to HLQ, self-regulation and in part to morningness (except digestive aR) (0.49 – 0.13, all p < 0.05). Conclusion An internal validation of the long-version scale of aR yielded consistent relationships with health versus illness, quality of life and personality. Further studies are required to clarify the issues of external validity, clinical and physiological relevance. PMID:18533043

  19. Patient-reported outcomes 3 months after spine surgery: is it an accurate predictor of 12-month outcome in real-world registry platforms?

    PubMed

    Parker, Scott L; Asher, Anthony L; Godil, Saniya S; Devin, Clinton J; McGirt, Matthew J

    2015-12-01

    OBJECT The health care landscape is rapidly shifting to incentivize quality of care rather than quantity of care. Quality and outcomes registry platforms lie at the center of all emerging evidence-driven reform models and will be used to inform decision makers in health care delivery. Obtaining real-world registry outcomes data from patients 12 months after spine surgery remains a challenge. The authors set out to determine whether 3-month patient-reported outcomes accurately predict 12-month outcomes and, hence, whether 3-month measurement systems suffice to identify effective versus noneffective spine care. METHODS All patients undergoing lumbar spine surgery for degenerative disease at a single medical institution over a 2-year period were enrolled in a prospective longitudinal registry. Patient-reported outcome instruments (numeric rating scale [NRS], Oswestry Disability Index [ODI], 12-Item Short Form Health Survey [SF-12], EQ-5D, and the Zung Self-Rating Depression Scale) were recorded prospectively at baseline and at 3 months and 12 months after surgery. Linear regression was performed to determine the independent association of 3- and 12-month outcome. Receiver operating characteristic (ROC) curve analysis was performed to determine whether improvement in general health state (EQ-5D) and disability (ODI) at 3 months accurately predicted improvement and achievement of minimum clinical important difference (MCID) at 12 months. RESULTS A total of 593 patients undergoing elective lumbar surgery were included in the study. There was a significant correlation between 3-month and 12-month EQ-5D (r = 0.71; p < 0.0001) and ODI (r = 0.70; p < 0.0001); however, the authors observed a sizable discrepancy in achievement of a clinically significant improvement (MCID) threshold at 3 versus 12 months on an individual patient level. For postoperative disability (ODI), 11.5% of patients who achieved an MCID threshold at 3 months dropped below this threshold at 12 months; 10

  20. Brief report: do service dog providers placing dogs with children with developmental disabilities use outcome measures and, if so, what are they?

    PubMed

    Butterly, Felicity; Percy, Carol; Ward, Gillian

    2013-11-01

    The aim of this study was to identify the outcomes expected and assessed by those providing service dogs to children with developmental disabilities. Seventeen registered service dog providers were invited to complete a mixed methods online survey. Five providers, who prepared dogs to work with a wide range of conditions and behaviours, mainly Asperger's syndrome, autism and communication disorders, completed the survey. All five participants reported that they expected to see positive changes as a consequence of the service dog placement, in both the recipient child and their family, including improvements in attention span and language skills, as well as increased familial cohesion. Survey responses indicated that not all desired outcomes were routinely assessed. The range of assessments used were interviews, intake conversations, pre-placement questionnaires, child social diaries filled in by parents, follow up surveys after placement, and child observation by parents. No specifically named valid and reliable clinical or research measures were referred to, showing an emphasis on assessments from parents and service dog providers. It is not clear whether pre-intervention assessments are repeated systematically at follow-up, which could show robust intervention effects. There is scope for professionals in developmental disability to work with service dog providers to improve the evidence base in this field.

  1. The public health hazards of risk avoidance associated with public reporting of risk-adjusted outcomes in coronary intervention.

    PubMed

    Resnic, Frederic S; Welt, Frederick G P

    2009-03-10

    Public reporting of risk-adjusted outcomes for percutaneous coronary intervention (PCI) procedures has been mandated in New York State for more than a decade. During that time there has been a significant decline in the unadjusted mortality after such procedures. Massachusetts joined New York in 2003 as only the second state to require case level reporting of every coronary interventional procedure performed. In this review, we explore the differences in the populations reported by the 2 states and consider possible risks of public reporting of clinical outcomes after PCI procedures, including the risk of increasing conservatism in the treatment of the sickest patients. We offer a conceptual framework to understand the potential risk-averse behavior of interventional cardiologists subject to public reporting, and offer several proposals to counteract this potential deleterious effect of reporting programs.

  2. The public health hazards of risk avoidance associated with public reporting of risk adjusted outcomes in coronary intervention

    PubMed Central

    Resnic, Frederic S.; Welt, Frederick G. P.

    2009-01-01

    Public reporting of risk adjusted outcomes for percutaneous coronary interventional (PCI) procedures has been mandated in New York State for more than a decade. Over that time there has been a significant decline in the unadjusted mortality following such procedures. Massachusetts joined New York in 2003 as only the second state to require case level reporting of every coronary interventional procedure performed. In this review, we explore the differences in the populations reported by the two states, and consider possible risks of public reporting of clinical outcomes following PCI procedures including the risk of increasing conservatism in the treatment of the sickest patients. We offer a conceptual framework to understand the potential risk-averse behavior of interventional cardiologists subject to public reporting, and offer several proposals to counteract this potential deleterious effect of reporting programs. PMID:19264236

  3. Impact of Certolizumab Pegol on Patient‐Reported Outcomes in Patients With Axial Spondyloarthritis

    PubMed Central

    Kivitz, A.; van Tubergen, A.; Deodhar, A.; Coteur, G.; Woltering, F.; Landewé, R.

    2015-01-01

    Objective Patient‐reported outcomes (PROs) provide an opportunity to collect important information relating to patient well‐being, which is often difficult for physicians to measure (e.g., quality of life, pain, fatigue, and sleep). Here we evaluate the effects of certolizumab pegol (CZP) on PROs during the 24‐week, double‐blind phase of the RAPID axial spondyloarthritis (SpA) trial, a phase 3 trial of axial SpA patients, including both ankylosing spondylitis (AS) and nonradiographic axial SpA patients. Methods A total of 325 patients with active axial SpA were randomized 1:1:1 to placebo, CZP 200 mg every 2 weeks, or CZP 400 mg every 4 weeks. The primary end point was the Assessment of SpondyloArthritis International Society criteria for 20% improvement in disease activity response at week 12, and has been reported previously. PROs included total back pain, nocturnal back pain, a daily pain diary, the Sleep Problems Index II (SPI) domain of the Medical Outcomes Study (MOS) Sleep Scale, fatigue, the Ankylosing Spondylitis Quality of Life (ASQOL) measure, and the Short Form 36‐item (SF‐36) health survey physical component summary (PCS), mental component summary (MCS), and domains. Results Patients treated with CZP reported significant improvements from week 1 for nocturnal back pain (placebo −0.6, CZP 200 mg every 2 weeks −1.9, and CZP 400 mg every 4 weeks −1.6; P < 0.001) and ASQOL (placebo −1.0, CZP 200 mg every 2 weeks −2.3, and CZP 400 mg every 4 weeks −1.9; P < 0.05) compared with placebo, while significant improvements in total back pain were seen from day 2. Patients treated with both CZP dosing regimens also had significantly greater improvements in fatigue, MOS‐SPI, SF‐36 PCS, MCS, and domains compared with placebo. Improvements were similar in both AS and nonradiographic axial SpA patients. Conclusion Both CZP dosing schedules rapidly improved patient well‐being, as measured by PROs, including pain, fatigue, sleep, SF‐36

  4. Interviewing to develop Patient-Reported Outcome (PRO) measures for clinical research: eliciting patients' experience.

    PubMed

    Brédart, Anne; Marrel, Alexia; Abetz-Webb, Linda; Lasch, Kathy; Acquadro, Catherine

    2014-02-05

    Patient-reported outcome (PRO) measures must provide evidence that their development followed a rigorous process for ensuring their content validity. To this end, the collection of data is performed through qualitative interviews that allow for the elicitation of in-depth spontaneous reports of the patients' experiences with their condition and/or its treatment. This paper provides a review of qualitative research applied to PRO measure development. A clear definition of what is a qualitative research interview is given as well as information about the form and content of qualitative interviews required for developing PRO measures. Particular attention is paid to the description of interviewing approaches (e.g., semi-structured and in-depth interviews, individual vs. focus group interviews). Information about how to get prepared for a qualitative interview is provided with the description of how to develop discussion guides for exploratory or cognitive interviews. Interviewing patients to obtain knowledge regarding their illness experience requires interpersonal and communication skills to facilitate patients' expression. Those skills are described in details, as well as the skills needed to facilitate focus groups and to interview children, adolescents and the elderly. Special attention is also given to quality assurance and interview training. The paper ends on ethical considerations since interviewing for the development of PROs is performed in a context of illness and vulnerability. Therefore, it is all the more important that, in addition to soliciting informed consent, respectful interactions be ensured throughout the interview process.

  5. Usefulness of Patients-Reported Outcomes in Rheumatoid Arthritis Focus Group

    PubMed Central

    Amaya-Amaya, Jenny; Botello-Corzo, Diana; Calixto, Omar-Javier; Calderón-Rojas, Rolando; Domínguez, Aura-Maria; Cruz-Tapias, Paola; Montoya-Ortiz, Gladis; Mantilla, Ruben-Dario; Anaya, Juan-Manuel; Rojas-Villarraga, Adriana

    2012-01-01

    Objective. Patient-reported outcomes (PROs) have become an essential part of the assessment of patients with rheumatoid arthritis (RA). We aimed to evaluate the agreement and correlation between PROs and the physician's measurements. Methods. This was a cross-sectional analytical study in which 135 patients with RA were clinically evaluated during two different sessions of focus group interviews. Rheumatologist recorded 28 swollen (SJCs) and tender joint counts (TJCs). The patients filled out the PROs instruments (MDHAQ, RADAI, RAPID3, 4, and 5 and self-report articular index (SAI) diagram for pain and joint swelling). DAS28 was calculated (C-reactive protein). An adjusted multiple lineal regression model was done (DAS28 as dependent variable). Results. Highly significant agreements were found between SJC and TJC registered by the physician and patient. There was moderate correlation between DAS28 with patient SJC (r = 0.52), patient TJC (r = 0.55), RADAI (r = 0.56), RAPID3 (r = 0.52), RAPID4 (r = 0.56), RAPID5 (r = 0.66), and VAS-Global (r = 0.51). Likewise, we found moderate to high correlations between CDAI and SDAI with all variable measurements done by the patients. The resulting predictive equation was DAS28(CRP) = 2.02 + 0.037 × RAPID4 + 0.042× patient SJC. Conclusion. PROs applied in focus groups interview are a useful tool for managing patients with RA regardless of gender, educational level, and duration of disease. PMID:23097701

  6. The regulation of patient-reported outcome claims: need for a flexible standard.

    PubMed

    Morris, Louis A; Miller, David W

    2002-01-01

    We review the FDA's policies for the regulation of patient-reported outcome (PRO) claims such as quality of life, productivity, satisfaction and symptom reports and suggest alternative standards for substantiation. We base our review on FDA regulatory activities and public statements in the field of advertising substantiation. We compare these activities to the FDA's label substantiation policies and policies for health-economic (HE) claim substantiation. There is an overt inconsistency between the FDA's policies for substantiation of PRO claims in product labels and substantiation for such claims in advertising materials. This results in a higher standard for PRO claims in promotional vehicles than in product labels. Rather than relying on a "substantial evidence" standard, the FDA should consider a more flexible standard, such as the one currently applied to information included in the Clinical Trials section of product labels, or adopting a "competent and reliable scientific evidence" standard as set forth in Section 114 of the Food and Drug Administration Modernization Act (FDAMA) for HE data. We conclude that there needs to be greater consistency for substantiation in product labels and promotional materials. Furthermore, reconceptualizing most PRO claims as benefit extrapolations as opposed to efficacy information suggests a less rigorous standard is necessary.

  7. Patient-reported outcomes before and after treatment of major depressive disorder.

    PubMed

    IsHak, Waguih William; Mirocha, James; Pi, Sarah; Tobia, Gabriel; Becker, Bret; Peselow, Eric D; Cohen, Robert M

    2014-06-01

    Patient reported outcomes (PROs) of quality of life (QoL), functioning, and depressive symptom severity are important in assessing the burden of illness of major depressive disorder (MDD) and to evaluate the impact of treatment. We sought to provide a detailed analysis of PROs before and after treatment of MDD from the large Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. This analysis examines PROs before and after treatment in the second level of STAR*D. The complete data on QoL, functioning, and depressive symptom severity, were analyzed for each STAR*D level 2 treatment. PROs of QoL, functioning, and depressive symptom severity showed substantial impairments after failing a selective serotonin reuptake inhibitor trial using citalopram (level 1). The seven therapeutic options in level 2 had positive statistically (P values) and clinically (Cohen's standardized differences [Cohen's d]) significant impact on QoL, functioning, depressive symptom severity, and reduction in calculated burden of illness. There were no statistically significant differences between the interventions. However, a substantial proportion of patients still suffered from patient-reported QoL and functioning impairment after treatment, an effect that was more pronounced in nonremitters. PROs are crucial in understanding the impact of MDD and in examining the effects of treatment interventions, both in research and clinical settings.

  8. Advantages and Psychometric Validation of Proximal Intensive Assessments of Patient Reported Outcomes Collected in Daily Life

    PubMed Central

    Carlson, Eve B.; Field, Nigel P.; Ruzek, Josef I.; Bryant, Richard A.; Dalenberg, Constance J.; Keane, Terence M.; Spain, David A.

    2016-01-01

    Objectives Ambulatory assessment data collection methods are increasingly used to study behavior, experiences, and patient reported outcomes (PROs) such as emotions, cognitions, and symptoms in clinical samples. Data collected close in time at frequent and fixed intervals can assess PROs that are discrete or changing rapidly and provide information about temporal dynamics or mechanisms of change in clinical samples and individuals, but clinical researchers have not yet routinely and systematically investigated the reliability and validity of such measures or their potential added value over conventional measures. The present study provides a comprehensive, systematic evaluation of the psychometrics of several Proximal Intensive Assessment (PIA) measures in a clinical sample and investigates whether PIA appears to assess meaningful differences in phenomena over time. Methods Data was collected on a variety of psychopathology constructs on handheld devices every 4 hours for 7 days from 62 adults recently exposed to traumatic injury of themselves or a family member. Data was also collected on standard self-report measures of the same constructs at the time of enrollment, one week after enrollment, and two months after injury. Results For all measure scores, results showed good internal consistency across items and within persons over time, provided evidence of convergent, divergent, and construct validity, and showed significant between and within-subject variability. Conclusions Results indicate that PIA measures can provide valid measurement of psychopathology in a clinical sample. PIA may be useful to study mechanisms of change in clinical contexts, identify targets for change, and gauge treatment progress. PMID:26567018

  9. Interviewing to develop Patient-Reported Outcome (PRO) measures for clinical research: eliciting patients’ experience

    PubMed Central

    2014-01-01

    Patient-reported outcome (PRO) measures must provide evidence that their development followed a rigorous process for ensuring their content validity. To this end, the collection of data is performed through qualitative interviews that allow for the elicitation of in-depth spontaneous reports of the patients’ experiences with their condition and/or its treatment. This paper provides a review of qualitative research applied to PRO measure development. A clear definition of what is a qualitative research interview is given as well as information about the form and content of qualitative interviews required for developing PRO measures. Particular attention is paid to the description of interviewing approaches (e.g., semi-structured and in-depth interviews, individual vs. focus group interviews). Information about how to get prepared for a qualitative interview is provided with the description of how to develop discussion guides for exploratory or cognitive interviews. Interviewing patients to obtain knowledge regarding their illness experience requires interpersonal and communication skills to facilitate patients’ expression. Those skills are described in details, as well as the skills needed to facilitate focus groups and to interview children, adolescents and the elderly. Special attention is also given to quality assurance and interview training. The paper ends on ethical considerations since interviewing for the development of PROs is performed in a context of illness and vulnerability. Therefore, it is all the more important that, in addition to soliciting informed consent, respectful interactions be ensured throughout the interview process. PMID:24499454

  10. Quality of Life and Patient-Reported Outcomes in Breast Cancer Survivors

    PubMed Central

    Macadam, Sheina A.; Zhong, Toni; Weichman, Katie; Papsdorf, Michael; Lennox, Peter A.; Hazen, Alexes; Matros, Evan; Disa, Joseph; Mehrara, Babak; Pusic, Andrea L.; Van Laeken, Nancy; Cordeiro, Peter; Vidal, Dale; Klassen, Anne; Cano, Stefan

    2016-01-01

    Background Approximately 20% of women select autologous tissue for postmastectomy breast reconstruction, and most commonly choose the abdomen as the donor site. An increasing proportion of women are seeking muscle-sparing procedures but the benefit remains controversial. It is therefore important to determine whether better outcomes are associated with these techniques, thereby justifying longer operative times and increased costs. Methods Patients from five North American centers were eligible if they had reconstruction using the deep inferior epigastric artery perforator flap (DIEP), muscle sparing free transverse abdominis myocutaneous flap (msf-TRAM), free transverse abdominis myocutaneous flap (f-TRAM), or the pedicled transverse abdominis myocutaneous flap (p-TRAM) with minimum one-year follow-up. Patients were sent the BREAST-Q©. Demographics and complications were collected by chart review. Results We analyzed 1790 charts representing 670 DIEP, 293 msf-TRAM, 683 p-TRAM, and 144 f-TRAM patients with average follow up of 5.5 years. Flap loss did not differ by flap type. Partial flap loss was higher in p-TRAM compared to DIEP (p=0.002). Fat necrosis was higher in p-TRAM compared to DIEP and msf-TRAM (p<0.001). Hernia/bulge was highest in p-TRAM (p<0.001). Physical Well-Being (Abdomen) scores were higher in DIEP compared to p-TRAM controlling for age, follow-up, BMI, laterality, abdominal surgery, mesh, radiation, income, and education. Conclusions Complications and patient-reported outcomes differ when comparing abdominally-based breast reconstruction techniques. The results of this study show that the DIEP was associated with the highest abdominal well-being and the lowest abdominal morbidity when compared to the p-TRAM, but did not differ from msf-TRAM and f-TRAM. PMID:26910656

  11. Muscle function is associated with future patient-reported outcomes in young adults with ACL injury

    PubMed Central

    Flosadottir, Vala; Roos, Ewa M; Ageberg, Eva

    2016-01-01

    Background/aim Consequences of an anterior cruciate ligament (ACL) injury include worse patient-reported outcomes (PROs) and a decrease in activity level. Muscle function can be improved by targeted exercise. Our aims were to investigate cross-sectional and longitudinal associations among lower extremity muscle function and PROs after ACL injury. Methods Fifty-four participants (15 women, mean 30 years) with ACL injury or reconstruction, from the Knee Anterior Cruciate Ligament, Nonsurgical versus Surgical Treatment (KANON) trial (ISRCTN84752559), were assessed with hop performance, muscle power and postural orientation 3 years (SD 0.85) after ACL injury. PROs at 3 and 5 years after injury included Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales Function in sport and recreation (KOOS Sport/rec) and Knee-related Quality of life (KOOS QoL), KOOS item Q3 (KOOS Q3), Tegner Activity Scale and Activity Rating Scale (ARS). Partial Spearman's rank-order correlation was used to analyse correlations between muscle function and PROs, controlling for gender and treatment. Results Numerous cross-sectional correlations were observed between muscle function and PROs (rsp≈0.3–0.5, p≤0.045). Worse hop performance and worse postural orientation were associated with worse KOOS scores 2 years later (rsp≥0.280, p≤0.045). Worse muscle power was associated with lower future ARS scores (rsp=0.281, p=0.044). Conclusions The moderate associations suggest that improving muscle function during rehabilitation could improve present and future PROs. PMID:27900196

  12. A Review of HIV-Specific Patient-Reported Outcome Measures.

    PubMed

    Engler, Kim; Lessard, David; Lebouché, Bertrand

    2016-09-16

    The use of patient-reported outcome (PRO) measures to provide added feedback to health providers is receiving interest as a means of improving clinical care and patient outcomes, and contributing to more patient-centered care. In human immunodeficiency virus (HIV), while PROs are used in research, their application in clinical practice has been limited despite their potential utility. PRO selection is an important consideration when contemplating their use. As past reviews of PROs in HIV have focused on particular areas (e.g. disability, satisfaction with care), a more comprehensive review could better inform on the available instruments and their scope. This article reviews HIV-specific PROs to produce an inventory and to identify the central concepts targeted over time. Seven databases were searched (HAPI, MEDLINE, PsychINFO, PubMed, EMBASE, CINAHL, Google Scholar), generating 14,794 records for evaluation. From these records, 117 HIV-specific PROs were identified and categorized based on a content analysis of their targeted concept: Health-Related Quality of Life (23; 20 %), ART and Adherence-Related Views and Experiences (19; 16 %), Healthcare-Related Views and Experiences (15; 13 %), Psychological Challenges (12; 10 %), Symptoms (12; 10 %), Psychological Resources (10; 9 %), HIV Self-Management and Self-Care (8; 7 %), HIV-Related Stigma (8; 7 %), Body and Facial Appearance (4; 3 %), Social Support (3; 3 %), Sexual and Reproductive Health (2; 2 %), and Disability (1; 1 %). This review highlights the variety and evolution of HIV-specific PROs, with the arrival of seven categories of PROs only after the advent of highly-active antiretroviral therapy. Our inventory also offers a useful resource. However, the interest of further HIV-specific PRO development should be explored in sexual health, which received little independent attention.

  13. Establishing a population-based patient-reported outcomes study (PROMs) using national cancer registries across two jurisdictions: the Prostate Cancer Treatment, your experience (PiCTure) study

    PubMed Central

    Drummond, F J; Kinnear, H; Donnelly, C; O'Leary, E; O'Brien, K; Burns, R M; Gavin, A; Sharp, L

    2015-01-01

    Objective To establish an international patient-reported outcomes (PROMs) study among prostate cancer survivors, up to 18 years postdiagnosis, in two countries with different healthcare systems and ethical frameworks. Design A cross-sectional, postal survey of prostate cancer survivors sampled and recruited via two population-based cancer registries. Healthcare professionals (HCPs) evaluated patients for eligibility to participate. Questionnaires contained validated instruments to assess health-related quality of life and psychological well-being, including QLQ-C30, QLQ-PR25, EQ-5D-5L, 21-question Depression, Anxiety and Stress Scale (DASS-21) and the Decisional Regret Scale. Setting Republic of Ireland (RoI) and Northern Ireland (NI). Primary outcome measures Registration completeness, predictors of eligibility and response, data missingness, unweighted and weighted PROMs. Results Prostate cancer registration was 80% (95% CI 75% to 84%) and 91% (95% CI 89% to 93%) complete 2 years postdiagnosis in NI and RoI, respectively. Of 12 322 survivors sampled from registries, 53% (n=6559) were classified as eligible following HCP screening. In the multivariate analysis, significant predictors of eligibility were: being ≤59 years of age at diagnosis (p<0.001), short-term survivor (<5 years postdiagnosis; p<0.001) and from RoI (p<0.001). 3348 completed the questionnaire, yielding a 54% adjusted response rate. 13% of men or their families called the study freephone with queries for assistance with questionnaire completion or to talk about their experience. Significant predictors of response in multivariate analysis were: being ≤59 years at diagnosis (p<0.001) and from RoI (p=0.016). Mean number of missing questions in validated instruments ranged from 0.12 (SD 0.71; EQ-5D-5L) to 3.72 (SD 6.30; QLQ-PR25). Weighted and unweighted mean EQ-5D-5L, QLQ-C30 and QLQ-PR25 scores were similar, as were the weighted and unweighted prevalences of depression, anxiety and

  14. Questionnaire typography and production.

    PubMed

    Gray, M

    1975-06-01

    This article describes the typographic principles and practice which provide the basis of good design and print, the relevant printing processes which can be used, and the graphic designer's function in questionnaire production. As they impose constraints on design decisions to be discussed later in the text, the various methods of printing and production are discussed first.

  15. Cultural adaptation: translatability assessment and linguistic validation of the patient-reported outcome instrument for irritable bowel syndrome with diarrhea

    PubMed Central

    Delgado-Herrera, Leticia; Lasch, Kathryn; Popielnicki, Ana; Nishida, Akito; Arbuckle, Rob; Banderas, Benjamin; Zentner, Susan; Gagainis, Ingrid; Zeiher, Bernhardt

    2016-01-01

    Background and objective Following a 2009 US Food and Drug Administration guidance, a new patient-reported outcome (PRO) instrument was developed to support end points in multinational clinical trials assessing irritable bowel syndrome with diarrhea (IBS-D) symptom severity. Our objective was to assess the translatability of the IBS-D PRO instrument into ten languages, and subsequently perform a cultural adaptation/linguistic validation of the questionnaire into Japanese and US Spanish. Materials and methods Translatability assessments of the US English version of the IBS-D PRO were performed by experienced PRO translators who were native speakers of each target language and currently residing in target-language countries. Languages were Chinese (People’s Republic of China), Dutch (the Netherlands), French (Belgium), German (Germany), Japanese (Japan), Polish (Poland), Portuguese (Brazil), Russian (Russia), Spanish (Mexico), and Spanish (US). The project team assessed the instrument to identify potential linguistic and/or cultural adaptation issues. After the issues identified were resolved, the instrument was translated into Spanish (US) and Japanese through a process of two forward translations, one reconciled translation, and one backward translation. The project team reviewed the translated versions before the instruments were evaluated by cognitive debriefing interviews with samples of five Spanish (US) and five Japanese IBS-D patients. Results Linguistic and cultural adaptation concerns identified during the translatability assessment required minor revisions, mainly the presentation of dates/times and word structure. During the cognitive debriefing interviews, two of five Spanish respondents misunderstood the term “bowel movement” to mean only diarrhea in the Spanish version. Consequently, the term was changed from “movimiento intestinal” to “evacuaciones”. None of the Japanese respondents identified issues with the Japanese version. Conclusion

  16. National questionnaire survey of TMA.

    PubMed

    Ito, Naomi; Wada, Hideo; Matsumoto, Masanori; Fujimura, Yoshihiro; Murata, Mitsuru; Izuno, Takashi; Sugita, Minoru; Ikeda, Yasuo

    2009-10-01

    A questionnaire survey of Japanese patients with thrombotic microangiopathy (TMA) was carried out to investigate the frequency, laboratory abnormalities, and outcome in 2004. Out of 185 patients, there were 13 with familial TMA and 172 with acquired TMA. In acquired TMA, there were 66 with Escherichia coli O-157 infection (O-157)-related TMA, 35 with ADAMTS13-related TMA, and 22 with other types of TMA. The frequency of TMA in O-157-related TMA was high in patients from 0- to 15-year-old, and acquired TMA without O-157 was frequently observed in patients ranging from 31 to 65 years of age. In the treatment of acquired TMA, including plasma exchange (PE), steroid, antiplatelet agent, and anticoagulant, PE was carried out in 94.3% of ADAMTS13-related TMA, 77.3% of other TMA, and 7.6% of O-157-related TMA. The efficacy of PE and steroid therapy tended to be higher in ADAMTS13 TMA than in other types of TMA. The complete remission rate is the highest in O-157 TMA. The mortality rate was the lowest for O-157 TMA, and this rate also tended to be lower in ADAMTS13-related TMA than in other types of TMA. However, the determination of ADAMTS13 was not universal in Japan at the time of this questionnaire.

  17. Patient-reported outcomes in ductal carcinoma in situ: A systematic review.

    PubMed

    King, Madeleine T; Winters, Zoë E; Olivotto, Ivo A; Spillane, Andrew J; Chua, Boon H; Saunders, Christobel; Westenberg, A Helen; Mann, G Bruce; Burnett, Petrina; Butow, Phyllis; Rutherford, Claudia

    2017-01-01

    Ductal carcinoma in situ (DCIS) is a pre-invasive breast cancer with excellent prognosis but with potential adverse impacts of diagnosis and treatment on quality of life and other patient-reported outcomes (PROs). We undertook a systematic review to synthesise current evidence about PROs following diagnosis and treatment for DCIS. We searched five electronic databases (from database inception to November 2015), cross-referenced and contacted experts to identify studies that reported PROs after DCIS treatment. Two reviewers independently applied inclusion and quality criteria, and extracted findings. Of 2130 papers screened, 23 were eligible, reporting 17 studies. Short- and long-term PRO evidence about differences between DCIS treatment options was lacking. Evidence pooled across treatments indicated core aspects of quality of life (physical, role, social, emotional function, pain, fatigue) and psychological distress (anxiety, depression) were impacted significantly initially, with most aspects returning to population norms by 6-12 months, and all by 2 years post-operatively. Fears of recurrence and dying from breast cancer were exaggerated, occurred early and persisted for many years. Sexuality and body image impacts were generally low and resolved within 1-3 months after surgery. A minority of women experienced considerable impact, including depression and sexual issues associated with body image problems. Well-powered PRO studies are required to track recovery trajectories and long-term impacts of the range of contemporary and emerging local and systemic treatments for DCIS. PRO data would enable care providers to prepare patients for short-term sequelae and enable patients who have treatment options to exercise preferences in choosing among them.

  18. Information perception, wishes, and satisfaction in ambulatory cancer patients under active treatment: patient-reported outcomes with QLQ-INFO25

    PubMed Central

    Pinto, Ana Catarina; Ferreira-Santos, Fernando; Lago, Lissandra Dal; de Azambuja, Evandro; Pimentel, Francisco Luís; Piccart-Gebhart, Martine; Razavi, Darius

    2014-01-01

    Background Information is vital to cancer patients. Physician–patient communication in oncology presents specific challenges. The aim of this study was to evaluate self-reported information of cancer patients in ambulatory care at a comprehensive cancer centre and examine its possible association with patients’ demographic and clinical characteristics. Patients and methods This study included adult patients with solid tumours undergoing chemotherapy at the Institute Jules Bordet’s Day Hospital over a ten-day period. EORTC QLQ-C30 and QLQ-INFO25 questionnaires were administered. Demographic and clinical data were collected. Descriptive and inferential statistics were used. Results 101 (99%) fully completed the questionnaires. They were mostly Belgian (74.3%), female (78.2%), with a mean age of 56.9 ± 12.8 years. The most frequent tumour was breast cancer (58.4%). Patients were well-informed about the disease and treatments, but presented unmet information domains. The Jules Bordet patients desired more information on treatment side effects, long-term outcome, nutrition, and recurrence symptoms. Patients on clinical trials reported having received less information about their disease and less written information than patients outside clinical trials. Higher information levels were associated with higher quality of life (QoL) scores and higher patient satisfaction. Conclusion Patients were satisfied with the information they received and this correlated with higher QoL, but they still expressed unmet information wishes. Additional studies are required to investigate the quality of the information received by patients enrolled in clinical trials. PMID:24834120

  19. Report from the kick-off meeting of the Cochrane Skin Group Core Outcome Set Initiative (CSG-COUSIN).

    PubMed

    Schmitt, J; Deckert, S; Alam, M; Apfelbacher, C; Barbaric, J; Bauer, A; Chalmers, J; Chosidow, O; Delamere, F; Doney, E; Eleftheriadou, V; Grainge, M; Johannsen, L; Kottner, J; Le Cleach, L; Mayer, A; Pinart, M; Prescott, L; Prinsen, C A C; Ratib, S; Schlager, J G; Sharma, M; Thomas, K S; Weberschock, T; Weller, K; Werner, R N; Wild, T; Wilkes, S R; Williams, H C

    2016-02-01

    A major obstacle of evidence-based clinical decision making is the use of nonstandardized, partly untested outcome measurement instruments. Core Outcome Sets (COSs) are currently developed in different medical fields to standardize and improve the selection of outcomes and outcome measurement instruments in clinical trials, in order to pool results of trials or to allow indirect comparison between interventions. A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population. The international, multidisciplinary Cochrane Skin Group Core Outcome Set Initiative (CSG-COUSIN) aims to develop and implement COSs in dermatology, thus making trial evidence comparable and, herewith, more useful for clinical decision making. The inaugural meeting of CSG-COUSIN was held on 17-18 March 2015 in Dresden, Germany, as the exclusive theme of the Annual Cochrane Skin Group Meeting. In total, 29 individuals representing a broad mix of different stakeholder groups, professions, skills and perspectives attended. This report provides a description of existing COS initiatives in dermatology, highlights current methodological challenges in COS development, and presents the concept, aims and structure of CSG-COUSIN.

  20. The Accuracy of the Child and Adolescent Intellectual Disability Screening Questionnaire (CAIDS-Q) in Classifying Severity of Impairment: A Brief Report

    ERIC Educational Resources Information Center

    Murray, A. L.; McKenzie, K.

    2014-01-01

    Background: Severity of intellectual disability (ID) is associated with a range of outcomes for the individual and having an indication of severity can help inform support needs. Previous research has not evaluated whether screening tools can accurately ascertain severity category in addition to providing a red flag for the presence of ID.…

  1. Beliefs about emotions as a metacognitive construct: initial development of a self-report questionnaire measure and preliminary investigation in relation to emotion regulation.

    PubMed

    Manser, Rachel; Cooper, Myra; Trefusis, Jo

    2012-01-01

    Metacognitive theory, amongst other theories, gives an important role to beliefs about mental states, including beliefs about emotions, in the maintenance of distress. Mentalization theory as well as the dialectical behaviour therapy and emotion-focused therapy literature specifies particular beliefs thought to be related to emotion dysregulation and therefore to a label of borderline personality disorder. The current study aimed to develop a questionnaire to measure the beliefs about emotions as specified by this literature and to test the relationship of this new measure to various aspects of emotion regulation in a non-clinical sample of 289 participants. A factor analysis extracted six factors, which described beliefs about emotions as (a) overwhelming and uncontrollable; (b) shameful and irrational; (c) invalid and meaningless; (d) useless; (e) damaging; and (f) contagious. The final measure showed some promising psychometric properties. All of the questionnaire subscales were related to aspects of emotion dysregulation including distress, borderline personality disorder symptoms and behaviours associated with dysregulation of emotion, suggesting that beliefs about emotions could be an important metacognitive construct involved in the ability to regulate emotions. Beliefs about emotions may be a useful direct or indirect target for treatment of difficulties regulating emotions, and this could be achieved through the use of various therapeutic modalities.

  2. Introduction of a Self-report Version of the Prescription Drug Use Questionnaire and Relationship to Medication Agreement Non-Compliance

    PubMed Central

    Compton, Peggy A.; Wu, Stephen M.; Schieffer, Beatrix; Pham, Quynh; Naliboff, Bruce D.

    2008-01-01

    The Prescription Drug Use Questionnaire (PDUQ) is one of several published tools developed to help clinicians better identify the presence of opioid abuse or dependence in patients with chronic pain. This paper introduces a patient version of the PDUQ (PDUQp), a 31-item questionnaire derived from the items of the original tool designed for self-administration, and describes evidence for its validity and reliability in a sample of patients with chronic nonmalignant pain and on opioid therapy. Further, this study examines instances of discontinuation from opioid medication treatment related to violation of the medication agreement (MAVRD) in this population, and the relationship of these with problematic opioid misuse behaviors, PDUQ and PDUQp scores. A sample of 135 consecutive patients with chronic nonmalignant pain was recruited from a multidisciplinary Veterans Affairs chronic pain clinic, and prospectively followed over one year of opioid therapy. Utilizing the PDUQ as a criterion measure, moderate to good concurrent and predictive validity data for the PDUQp are presented, as well as item-by-item comparison of the two formats. Reliability data indicate moderate test stability over time. Of those patients whose opioid treatment was discontinued due to MAVRD (n = 38 or 28% of sample), 40% of these (n = 11) were due to specific problematic opioid misuse behaviors. Based upon specificity and sensitivity analyses, a suggested cut-off PDUQp score for predicting MAVRD is provided. This study supports the PDUQp as a useful tool for assessing and predicting problematic opioid medication use in a chronic pain patient sample. PMID:18508231

  3. The Challenging Experience Questionnaire: Characterization of challenging experiences with psilocybin mushrooms.

    PubMed

    Barrett, Frederick S; Bradstreet, Matthew P; Leoutsakos, Jeannie-Marie S; Johnson, Matthew W; Griffiths, Roland R

    2016-12-01

    Acute adverse psychological reactions to classic hallucinogens ("bad trips" or "challenging experiences"), while usually benign with proper screening, preparation, and support in controlled settings, remain a safety concern in uncontrolled settings (such as illicit use contexts). Anecdotal and case reports suggest potential adverse acute symptoms including affective (panic, depressed mood), cognitive (confusion, feelings of losing sanity), and somatic (nausea, heart palpitation) symptoms. Responses to items from several hallucinogen-sensitive questionnaires (Hallucinogen Rating Scale, the States of Consciousness Questionnaire, and the Five-Dimensional Altered States of Consciousness questionnaire) in an Internet survey of challenging experiences with the classic hallucinogen psilocybin were used to construct and validate a Challenging Experience Questionnaire. The stand-alone Challenging Experience Questionnaire was then validated in a separate sample. Seven Challenging Experience Questionnaire factors (grief, fear, death, insanity, isolation, physical distress, and paranoia) provide a phenomenological profile of challenging aspects of experiences with psilocybin. Factor scores were associated with difficulty, meaningfulness, spiritual significance, and change in well-being attributed to the challenging experiences. The factor structure did not differ based on gender or prior struggle with anxiety or depression. The Challenging Experience Questionnaire provides a basis for future investigation of predictors and outcomes of challenging experiences with classic hallucinogens.

  4. Regenerative Endodontic Treatment: Report of Two Cases with Different Clinical Management and Outcomes

    PubMed Central

    Khoshkhounejad, Mehrfam; Shokouhinejad, Noushin

    2015-01-01

    Endodontic intervention in necrotic immature permanent teeth is usually a clinical challenge. With appropriate case selection, regenerative treatment can be effective, providing a desirable outcome. However, there is still no consensus on the optimal disinfection protocol or the method to achieve predictable clinical outcome. This article presents two cases of regenerative treatment in necrotic immature teeth, using mineral trioxide aggregate (MTA) and BiodentineTM as coronal barriers and different irrigants, which led to different clinical outcomes. PMID:26884781

  5. Modeling Associations between Principals’ Reported Indoor Environmental Quality and Students’ Self-Reported Respiratory Health Outcomes Using GLMM and ZIP Models

    PubMed Central

    Toyinbo, Oluyemi; Matilainen, Markus; Turunen, Mari; Putus, Tuula; Shaughnessy, Richard; Haverinen-Shaughnessy, Ulla

    2016-01-01

    Background: The aim of this paper was to examine associations between school building characteristics, indoor environmental quality (IEQ), and health responses using questionnaire data from both school principals and students. Methods: From 334 randomly sampled schools, 4248 sixth grade students from 297 schools participated in a questionnaire. From these schools, 134 principals returned questionnaires concerning 51 IEQ related questions of their school. Generalized linear mixed models (GLMM) were used to study the associations between IEQ indicators and existence of self-reported upper respiratory symptoms, while hierarchical Zero Inflated Poisson (ZIP)—models were used to model the number of symptoms. Results: Significant associations were established between existence of upper respiratory symptoms and unsatisfactory classroom temperature during the heating season (ORs 1.45 for too hot and cold, and 1.27 for too cold as compared to satisfactory temperature) and dampness or moisture damage during the year 2006–2007 (OR: 1.80 as compared to no moisture damage), respectively. The number of upper respiratory symptoms was significantly associated with inadequate ventilation and dampness or moisture damage. A higher number of missed school days due to respiratory infections were reported in schools with inadequate ventilation (RR: 1.16). Conclusions: The school level IEQ indicator variables described in this paper could explain a relatively large part of the school level variation observed in the self-reported upper respiratory symptoms and missed school days due to respiratory infections among students. PMID:27043595

  6. Limitations of asthma control questionnaires in the management and follow up of childhood asthma.

    PubMed

    Carroll, Will

    2013-12-01

    It is important to achieve asthma control whenever possible in clinical practice. Asthma control questionnaires undoubtedly provide a useful measure of asthma control in research studies but their place in routine clinical practice has yet to be secured. There is considerable variation in the results yielded from different validated asthma control tools. It remains to be seen whether they improve the reliability of reporting of symptoms to health care professionals when compared to verbal reporting. In the presence of sensible care from compassionate and well informed doctors and nurses asthma control questionnaires will not improve outcomes for children. A patient-focused clinical encounter supplemented with lung function measurements and occasional eNO testing has more to offer families and children than control questionnaires and their routine use in the clinic cannot be recommended on the basis of current evidence.

  7. Collecting, Integrating, and Disseminating Patient-Reported Outcomes for Research in a Learning Healthcare System

    PubMed Central

    Harle, Christopher A.; Lipori, Gloria; Hurley, Robert W.

    2016-01-01

    Introduction: Advances in health policy, research, and information technology have converged to increase the electronic collection and use of patient-reported outcomes (PROs). Therefore, it is important to share lessons learned in implementing PROs in research information systems. Case Description: The purpose of this case study is to describe a novel information system for electronic PROs and lessons learned in implementing that system to support research in an academic health center. The system incorporates freely available and commercial software and involves clinical and research workflows that support the collection, transformation, and research use of PRO data. The software and processes that comprise the system serve three main functions, (i) collecting electronic PROs in clinical care, (ii) integrating PRO data with non-patient generated clinical data, and (iii) disseminating data to researchers through the institution’s research informatics infrastructure, including the i2b2 (Informatics for Integrating Biology and the Bedside) system. Strategies: Our successful design and implementation was driven by three overarching strategies. First, we selected and implemented multiple interfaced technologies to support PRO collection, management, and research use. Second, we aimed to use standardized approaches to measuring PROs, sending PROs between systems, and disseminating PROs. Finally, we focused on using technologies and processes that aligned with existing clinical research information management strategies within our organization. Conclusion: These experiences and lessons may help future implementers and researchers enhance the scale and sustainable use of systems for research use of PROs. PMID:27563683

  8. Practical and statistical issues in missing data for longitudinal patient-reported outcomes.

    PubMed

    Bell, Melanie L; Fairclough, Diane L

    2014-10-01

    Patient-reported outcomes are increasingly used in health research, including randomized controlled trials and observational studies. However, the validity of results in longitudinal studies can crucially hinge on the handling of missing data. This paper considers the issues of missing data at each stage of research. Practical strategies for minimizing missingness through careful study design and conduct are given. Statistical approaches that are commonly used, but should be avoided, are discussed, including how these methods can yield biased and misleading results. Methods that are valid for data which are missing at random are outlined, including maximum likelihood methods, multiple imputation and extensions to generalized estimating equations: weighted generalized estimating equations, generalized estimating equations with multiple imputation, and doubly robust generalized estimating equations. Finally, we discuss the importance of sensitivity analyses, including the role of missing not at random models, such as pattern mixture, selection, and shared parameter models. We demonstrate many of these concepts with data from a randomized controlled clinical trial on renal cancer patients, and show that the results are dependent on missingness assumptions and the statistical approach.

  9. Use of an electronic patient-reported outcome measurement system to improve distress management in oncology

    PubMed Central

    Smith, Sophia K.; Rowe, Krista; Abernethy, Amy P.

    2014-01-01

    Objective Management of patient distress is a critical task in cancer nursing and cancer practice. Here we describe two examples of how an electronic patient-reported outcome (ePRO) measurement system implemented into routine oncology care can practically aid clinical and research tasks related to distress management. Methods Tablet personal computers were used to routinely complete a standardized ePRO review of systems surveys at point of care during every encounter in the Duke Oncology outpatient clinics. Two cases of use implementation are explored: (1) triaging distressed patients for optimal care, and (2) psychosocial program evaluation research. Results Between 2009 and 2011, the ePRO system was used to collect information during 17,338 Duke Oncology patient encounters. The system was used to monitor patients for psychosocial distress employing an electronic clinical decision support algorithm, with 1,952 (11.3%) referrals generated for supportive services. The system was utilized to examine the efficacy of a psychosocial care intervention documenting statistically significant improvements in distress, despair, fatigue, and quality of life (QOL) in 50 breast cancer patients. Significance of results ePRO solutions can guide best practice management of cancer patient distress. Nurses play a key role in implementation and utilization. PMID:24128592

  10. Measuring the value of treatment to patients: patient-reported outcomes in drug development.

    PubMed

    Willke, Richard J

    2008-02-01

    Patient-reported outcomes (PROs) can be important measures of the impact and value of new drug treatments to patients. Recently, both multisector stakeholder groups and the U.S. Food and Drug Administration have carefully considered and issued guidance on best practices for the use of PROs in measuring treatment impact. When best practices are followed and PRO data are appropriately included in drug development strategy and clinical trials, these data can be part of the evidence submitted for drug approval and included in drug labeling. One study showed that PRO data were included in 30% of a sample of new drug labels and were more concentrated in certain therapeutic areas, such as anti-inflammatory agents, vaccines, gastrointestinal agents, and respiratory and urologic agents. PRO data included in labeling, or generated in a similar scientific manner, may often then be used in other communication vehicles, such as formulary submission dossiers, journal or direct-to-consumer advertisements, publications, or continuing medical education. Meaningful and reliable PRO results regarding the effects of new treatments on how patients feel and function provide useful information to those who must make decisions about the availability and utilization of such treatments.

  11. Impact of genomic testing and patient-reported outcomes on receipt of adjuvant chemotherapy.

    PubMed

    Evans, Chalanda N; Brewer, Noel T; Vadaparampil, Susan T; Boisvert, Marc; Ottaviano, Yvonne; Lee, M Catherine; Isaacs, Claudine; Schwartz, Marc D; O'Neill, Suzanne C

    2016-04-01

    Practice guidelines incorporate genomic tumor profiling, using results such as the Oncotype DX Recurrence Score (RS), to refine recurrence risk estimates for the large proportion of breast cancer patients with early-stage, estrogen receptor-positive disease. We sought to understand the impact of receiving genomic recurrence risk estimates on breast cancer patients' well-being and the impact of these patient-reported outcomes on receipt of adjuvant chemotherapy. Participants were 193 women (mean age 57) newly diagnosed with early-stage breast cancer. Women were interviewed before and 2-3 weeks after receiving the RS result between 2011 and 2015. We assessed subsequent receipt of chemotherapy from chart review. After receiving their RS, perceived pros (t = 4.27, P < .001) and cons (t = 8.54, P < .001) of chemotherapy increased from pre-test to post-test, while perceived risk of breast cancer recurrence decreased (t = 2.90, P = .004). Women with high RS tumors were more likely to receive chemotherapy than women with low RS tumors (88 vs. 5 %, OR 0.01, 0.00-0.02, P < .001). Higher distress (OR 2.19, 95 % CI 1.05-4.57, P < .05) and lower perceived cons of chemotherapy (OR 0.50, 95 % CI 0.26-0.97, P < .05) also predicted receipt of chemotherapy. Distressed patients who saw few downsides of chemotherapy received this treatment. Clinicians should consider these factors when discussing chemotherapy with breast cancer patients.

  12. Trajectory and outcomes of speech language therapy in the Prader-Willi syndrome (PWS): case report.

    PubMed

    Misquiatti, Andréa Regina Nunes; Cristovão, Melina Pavini; Brito, Maria Claudia

    2011-03-01

    The aim of this study was to describe the trajectory and the outcomes of speech-language therapy in Prader-Willi syndrome through a longitudinal study of the case of an 8 year-old boy, along four years of speech-language therapy follow-up. The therapy sessions were filmed and documental analysis of information from the child's records regarding anamnesis, evaluation and speech-language therapy reports and multidisciplinary evaluations were carried out. The child presented typical characteristics of Prader-Willi syndrome, such as obesity, hyperfagia, anxiety, behavioral problems and self aggression episodes. Speech-language pathology evaluation showed orofacial hypotony, sialorrhea, hypernasal voice, cognitive deficits, oral comprehension difficulties, communication using gestures and unintelligible isolated words. Initially, speech-language therapy had the aim to promote the language development emphasizing social interaction through recreational activities. With the evolution of the case, the main focus became the development of conversation and narrative abilities. It were observed improvements in attention, symbolic play, social contact and behavior. Moreover, there was an increase in vocabulary, and evolution in oral comprehension and the development of narrative abilities. Hence, speech-language pathology intervention in the case described was effective in different linguistic levels, regarding phonological, syntactic, lexical and pragmatic abilities.

  13. Patient-Reported Outcomes and Survivorship in Radiation Oncology: Overcoming the Cons

    PubMed Central

    Siddiqui, Farzan; Liu, Arthur K.; Watkins-Bruner, Deborah; Movsas, Benjamin

    2014-01-01

    Purpose Although patient-reported outcomes (PROs) have become a key component of clinical oncology trials, many challenges exist regarding their optimal application. The goal of this article is to methodically review these barriers and suggest strategies to overcome them. This review will primarily focus on radiation oncology examples, will address issues regarding the “why, how, and what” of PROs, and will provide strategies for difficult problems such as methods for reducing missing data. This review will also address cancer survivorship because it closely relates to PROs. Methods Key articles focusing on PROs, quality of life, and survivorship issues in oncology trials are highlighted, with an emphasis on radiation oncology clinical trials. Publications and Web sites of various governmental and regulatory agencies are also reviewed. Results The study of PROs in clinical oncology trials has become well established. There are guidelines provided by organizations such as the US Food and Drug Administration that clearly indicate the importance of and methodology for studying PROs. Clinical trials in oncology have repeatedly demonstrated the value of studying PROs and suggested ways to overcome some of the key challenges. The Radiation Therapy Oncology Group (RTOG) has led some of these efforts, and their contributions are highlighted. The current state of cancer survivorship guidelines is also discussed. Conclusion The study of PROs presents significant benefits in understanding and treating toxicities and enhancing quality of life; however, challenges remain. Strategies are presented to overcome these hurdles, which will ultimately improve cancer survivorship. PMID:25113760

  14. The importance of rating scales in measuring patient-reported outcomes

    PubMed Central

    2012-01-01

    Background A critical component that influences the measurement properties of a patient-reported outcome (PRO) instrument is the rating scale. Yet, there is a lack of general consensus regarding optimal rating scale format, including aspects of question structure, the number and the labels of response categories. This study aims to explore the characteristics of rating scales that function well and those that do not, and thereby develop guidelines for formulating rating scales. Methods Seventeen existing PROs designed to measure vision-related quality of life dimensions were mailed for self-administration, in sets of 10, to patients who were on a waiting list for cataract extraction. These PROs included questions with ratings of difficulty, frequency, severity, and global ratings. Using Rasch analysis, performance of rating scales were assessed by examining hierarchical ordering (indicating categories are distinct from each other and follow a logical transition from lower to higher value), evenness (indicating relative utilization of categories), and range (indicating coverage of the attribute by the rating scale). Results The rating scales with complicated question format, a large number of response categories, or unlabelled categories, tended to be dysfunctional. Rating scales with five or fewer response categories tended to be functional. Most of the rating scales measuring difficulty performed well. The rating scales measuring frequency and severity demonstrated hierarchical ordering but the categories lacked even utilization. Conclusion Developers of PRO instruments should use a simple question format, fewer (four to five) and labelled response categories. PMID:22794788

  15. Food frequency questionnaires.

    PubMed

    Pérez Rodrigo, Carmen; Aranceta, Javier; Salvador, Gemma; Varela-Moreiras, Gregorio

    2015-02-26

    Food Frequency Questionnaires are dietary assessment tools widely used in epidemiological studies investigating the relationship between dietary intake and disease or risk factors since the early '90s. The three main components of these questionnaires are the list of foods, frequency of consumption and the portion size consumed. The food list should reflect the food habits of the study population at the time the data is collected. The frequency of consumption may be asked by open ended questions or by presenting frequency categories. Qualitative Food Frequency Questionnaires do not ask about the consumed portions; semi-quantitative include standard portions and quantitative questionnaires ask respondents to estimate the portion size consumed either in household measures or grams. The latter implies a greater participant burden. Some versions include only close-ended questions in a standardized format, while others add an open section with questions about some specific food habits and practices and admit additions to the food list for foods and beverages consumed which are not included. The method can be self-administered, on paper or web-based, or interview administered either face-to-face or by telephone. Due to the standard format, especially closed-ended versions, and method of administration, FFQs are highly cost-effective thus encouraging its widespread use in large scale epidemiological cohort studies and also in other study designs. Coding and processing data collected is also less costly and requires less nutrition expertise compared to other dietary intake assessment methods. However, the main limitations are systematic errors and biases in estimates. Important efforts are being developed to improve the quality of the information. It has been recommended the use of FFQs with other methods thus enabling the adjustments required.

  16. Longitudinal evaluation of Patient Reported Outcomes Measurement Information Systems (PROMIS) measures in pediatric chronic pain

    PubMed Central

    Kashikar-Zuck, Susmita; Carle, Adam; Barnett, Kimberly; Goldschneider, Kenneth R.; Sherry, David D.; Mara, Constance A.; Cunningham, Natoshia; Farrell, Jennifer; Tress, Jenna; DeWitt, Esi Morgan

    2015-01-01

    The Patient Reported Outcomes Measurement Information System (PROMIS) initiative is a comprehensive strategy by the National Institutes of Health to support the development and validation of precise instruments to assess self-reported health domains across healthy and disease-specific populations. Much progress has been made in instrument development but there remains a gap in the validation of PROMIS measures for pediatric chronic pain. The purpose of this study was to investigate the construct validity and responsiveness to change of seven PROMIS domains for the assessment of children (ages 8-18) with chronic pain – Pain Interference, Fatigue, Anxiety, Depression, Mobility, Upper Extremity Function and Peer Relationships. PROMIS measures were administered at the initial visit and two follow-up visits at an outpatient chronic pain clinic (CPC; N=82) and at an intensive amplified pain day-treatment program (AMP; N= 63). Aim 1 examined construct validity of PROMIS measures by comparing them with corresponding “legacy” measures administered as part of usual care in the CPC sample. Aim 2 examined sensitivity to change in both CPC and AMP samples. Longitudinal growth models showed that PROMIS Pain Interference, Anxiety, Depression, Mobility, Upper Extremity and Peer Relationship measures and legacy instruments generally performed similarly with slightly steeper slopes of improvement in legacy measures. All seven PROMIS domains showed responsiveness to change. Results offered initial support for the validity of PROMIS measures in pediatric chronic pain. Further validation with larger and more diverse pediatric pain samples and additional legacy measures would broaden the scope of use of PROMIS in clinical research. PMID:26447704

  17. What is sufficient evidence for the reliability and validity of patient-reported outcome measures?

    PubMed

    Frost, Marlene H; Reeve, Bryce B; Liepa, Astra M; Stauffer, Joseph W; Hays, Ron D

    2007-01-01

    This article focuses on the necessary psychometric properties of a patient-reported outcomes (PROs) measure. Topics include the importance of reliability and validity, psychometric approaches used to provide reliability and validity estimates, the kinds of evidence needed to indicate that a PRO has a sufficient level of reliability and validity, contexts that may affect psychometric properties, methods available to evaluate PRO instruments when the context varies, and types of reliability and validity testing that are appropriate during different phases of clinical trials. Points discussed include the perspective that the psychometric properties of reliability and validity are on a continuum in which the more evidence one has, the greater confidence there is in the value of the PRO data. Construct validity is the type of validity most frequently used with PRO instruments as few "gold standards" exist to allow the use of criterion validity and content validity by itself only provides beginning evidence of validity. Several guidelines are recommended for establishing sufficient evidence of reliability and validity. For clinical trials, a minimum reliability threshold of 0.70 is recommended. Sample sizes for testing should include at least 200 cases and results should be replicated in at least one additional sample. At least one full report on the development of the instrument and one on the use of the instrument are deemed necessary to evaluate the PRO psychometric properties. Psychometric testing ideally occurs before the initiation of Phase III trials. When testing does not occur prior to a Phase III trial, considerable risk is posed in relation to the ability to substantiate the use of the PRO data. Various qualitative (e.g., focus groups, behavioral coding, cognitive interviews) and quantitative approaches (e.g., differential item functioning testing) are useful in evaluating the reliability and validity of PRO instruments.

  18. Longitudinal evaluation of patient-reported outcomes measurement information systems measures in pediatric chronic pain.

    PubMed

    Kashikar-Zuck, Susmita; Carle, Adam; Barnett, Kimberly; Goldschneider, Kenneth R; Sherry, David D; Mara, Constance A; Cunningham, Natoshia; Farrell, Jennifer; Tress, Jenna; DeWitt, Esi Morgan

    2016-02-01

    The Patient-Reported Outcomes Measurement Information System (PROMIS) initiative is a comprehensive strategy by the National Institutes of Health to support the development and validation of precise instruments to assess self-reported health domains across healthy and disease-specific populations. Much progress has been made in instrument development, but there remains a gap in the validation of PROMIS measures for pediatric chronic pain. The purpose of this study was to investigate the construct validity and responsiveness to change of 7 PROMIS domains for the assessment of children (ages: 8-18) with chronic pain--Pain Interference, Fatigue, Anxiety, Depression, Mobility, Upper Extremity Function, and Peer Relationships. The PROMIS measures were administered at the initial visit and 2 follow-up visits at an outpatient chronic pain clinic (CPC; N = 82) and at an intensive amplified musculoskeletal pain day-treatment program (N = 63). Aim 1 examined construct validity of PROMIS measures by comparing them with corresponding "legacy" measures administered as part of usual care in the CPC sample. Aim 2 examined sensitivity to change in both CPC and amplified musculoskeletal pain samples. Longitudinal growth models showed that PROMIS' Pain Interference, Anxiety, Depression, Mobility, Upper Extremity, and Peer Relationship measures and legacy instruments generally performed similarly with slightly steeper slopes of improvement in legacy measures. All 7 PROMIS domains showed responsiveness to change. Results offered initial support for the validity of PROMIS measures in pediatric chronic pain. Further validation with larger and more diverse pediatric pain samples and additional legacy measures would broaden the scope of use of PROMIS in clinical research.

  19. Patient-reported outcome following nonsurgical management of type II odontoid process fractures in adults

    PubMed Central

    Fam, Maged D; Zeineddine, Hussein A; Nassir, Rafiq Muhammed; Bhatt, Pragnesh; Kamel, Mahmoud H

    2017-01-01

    Background: Transverse (type II) odontoid process fracture is among the most commonly encountered cervical spine fractures. Nonsurgical management through external immobilization is occasionally preferred to surgical management but is criticized for its higher rates of failure and lower patient satisfaction. Our aim is to analyze patient-reported outcomes in patients who underwent nonsurgical treatment for type II odontoid fractures. Methods: We identified patients >18-year-old who underwent external immobilization as a treatment for isolated type II odontoid fracture between 2007 and 2012. We collected demographic parameters, clinical presentation, mode of injury, imaging studies and modality and duration of treatment (soft collar, halo-vest, or both). Patients were contacted by telephone to participate in a 15-min survey addressing their recovery including their subjective rate of return to preinjury level of functioning. Results: Fifteen patients met the inclusion/exclusion criteria and participated in our survey. Patients were followed up for an average of 19 months after injury. Overall mean age was 61 years. Injury followed a mechanical fall or a road traffic accident in 11 and 4 cases, respectively. External immobilization was achieved by halo vest only in nine patients, soft collar only in two patients (13%), and through a sequential combination in the remaining 4 (27%). This was deployed for a mean of 7.8 months. Radiological studies at the last follow-up showed bony healing (27%), fibrous nonunion (60%), and persistent instability (13%). Patients reported gradual recovery of function throughout the 1st year after injury with levels above 70% of preinjury functioning achieved by 13% of patients at 6 months, 33% at 9 months, and 47% at 12 months. Overall satisfaction with nonsurgical management was 68%. Conclusion: In selected patients with type II odontoid fractures, external immobilization represents a good option with acceptable course of recovery. PMID

  20. All Seasons Vertical Augmentation Mastopexy: A Simple Algorithm, Clinical Experience, and Patient-reported Outcomes

    PubMed Central

    2016-01-01

    Background: The safety of augmentation mastopexy has been questioned. Staging has been recommended for women deemed to be at higher risk, such as women with greater degrees of ptosis. Most existing studies evaluate women treated with multiple methods, including the traditional Wise pattern. This retrospective study specifically evaluates vertical augmentation mastopexy. A simple algorithm is introduced. Methods: From 2002 to 2016, 252 women underwent consecutive vertical augmentation mastopexies performed by the author, with no staged surgery. All patients underwent a vertical mastopexy using a medially based pedicle and intraoperative nipple siting. A subset of women treated from 2012 to 2016 were surveyed to obtain outcome data; 90 patients (inclusion rate, 90%) participated. Results: The complication rate was 32.9%, including persistent ptosis, delayed wound healing, scar deformities, and asymmetry. There were no cases of nipple loss. An increased risk of complications was detected for smokers (P < 0.01), but not for combined procedures, secondary breast augmentations, or secondary mastopexies. The revision rate was 15.5%. Persistent nipple numbness was reported by 13.3% of respondents. Eighty percent of women were self-conscious about their breast appearance before surgery; 22% of respondents were self-conscious about their breasts after surgery. Seventy percent of respondents reported an improved quality of life, 94.4% would repeat the surgery, and 95.6% would recommend it. Conclusions: A simple algorithm may be used to guide treatment in women who desire correction of ptosis and upper pole fullness. An "all seasons" vertical augmentation mastopexy is safe and widely applicable. Staging is unnecessary. PMID:28293517

  1. Outcomes of hip resurfacing in a professional dancer: a case report.

    PubMed

    Dunleavy, Kim

    2012-02-01

    A new surgical option (hip resurfacing arthroplasty) is now available for younger patients with hip osteoarthritis. A more aggressive rehabilitation program than the typical total hip arthroplasty protocol is needed for active individuals. This case report describes interventions used to maximize function in a 46-year-old professional dancer after hip resurfacing with a progressive therapeutic exercise program. Exercise choices were selected to address dance-specific requirements while respecting healing of the posterior capsular incision. Strengthening focused on hip abduction, extension, and external rotation. Precautions included avoiding gluteal stretching until 6 months. Pelvic alignment and weight-bearing distribution were emphasized. The patient was able to return to rehearsal by 7 months, at which time strength was equivalent to the unaffected leg. Range of motion reached unaffected side values at week 8 for internal rotation, week 11 for extension, week 13 for adduction, and week 28 for flexion. External rotation and abduction were still limited at 1 year, which influenced pelvic alignment with resultant pain on the unaffected side. Functional and impairment outcomes are presented with timelines to provide a basis for postoperative benchmarks for active clients after hip resurfacing. Although this case report presents a dance-specific program, exercise progressions for other active individuals may benefit from similar exercise intensity and sports-specific focus. Future rehabilitation programs should take into account possible flexion and external rotation range limitations and the need for gluteal muscle strengthening along with symmetry and pelvic alignment correction. Long-term studies investigating intensity of rehabilitation are warranted for patients intending to participate in higher level athletic activity.

  2. Development and Validation of the Eyelash Satisfaction Questionnaire

    PubMed Central

    Dang, Jeff; Cole, Jason C.; Burgess, Somali M.; Yang, Min; Daniels, Selena R.; Walt, John G.

    2016-01-01

    Background Patient-reported outcome (PRO) measures have been used to assess treatment benefit in a variety of therapeutic areas and are now becoming increasingly important in aesthetic research. Objectives The objective of the current study was to develop and validate a new PRO measure (Eyelash Satisfaction Questionnaire [ESQ]) to assess satisfaction with eyelash prominence. Methods The content of the questionnaire (including conceptual framework and questionnaire items) was generated by review of literature, participant interviews, and expert opinion. Cognitive interviews were conducted to pilot test the questionnaire. Psychometric properties of the questionnaire were examined in a combined sample of participants (n = 970) completing Internet- (n = 909) and paper-based (n = 61) versions. Item- and domain-level properties were examined using modern and classical psychometrics. Results Content-based analysis of qualitative data demonstrated the presence of 3 distinct domains (Length, Fullness, Overall Satisfaction; Confidence, Attractiveness, and Professionalism; and Daily Routine). Initial confirmatory factor analysis (CFA) results of 23 items revealed insufficient model-data fit (comparative fit index [CFI] of 0.86 and a non-normed fit index [NNFI] of 0.82). A revised model using 9 items (3 per domain) achieved appropriate fit (CFI of 0.99 and NNFI of 0.97). Analyses revealed measurement equivalence across the Internet- and paper-based versions. The 3 ESQ domains had strong internal consistency reliability (Cronbach's α [range] = 0.919-0.976) and adequate convergent and discriminant validity. Conclusions The ESQ was found to be a reliable and valid PRO measure for assessing satisfaction with eyelash prominence. Level of Evidence: 3 Therapeutic PMID:26691738

  3. The Relationship between Components of the Ohio Local School District Report Card and the Outcome of a School Tax Levy

    ERIC Educational Resources Information Center

    Wheatley, Vicki Ann

    2012-01-01

    The relationship between components of the local school district report card, school district typology, and the outcome of public school tax levy requests were examined in this study. A correlation research design was used to measure the relationship between the independent variables (performance index, average yearly progress, value added,…

  4. Reporting and Handling Missing Outcome Data in Mental Health: A Systematic Review of Cochrane Systematic Reviews and Meta-Analyses

    ERIC Educational Resources Information Center

    Spineli, Loukia M.; Pandis, Nikolaos; Salanti, Georgia

    2015-01-01

    Objectives: The purpose of the study was to provide empirical evidence about the reporting of methodology to address missing outcome data and the acknowledgement of their impact in Cochrane systematic reviews in the mental health field. Methods: Systematic reviews published in the Cochrane Database of Systematic Reviews after January 1, 2009 by…

  5. The Effect of Comorbid AD/HD and Learning Disabilities on Parent-Reported Behavioral and Academic Outcomes of Children

    ERIC Educational Resources Information Center

    Smith, Thomas J.; Adams, Gail

    2006-01-01

    Data from the 2001 National Household Education Survey were examined to estimate the prevalence of comorbid AD/HD and LD among school-aged children in the United States and assess how this comorbidity was associated with selected parent-reported behavioral and academic outcomes. The observed prevalence of comorbidity coincided with estimates in…

  6. Low-SES Students and College Outcomes: The Role of AP® Fee Reductions. Research Report No. 2011-9

    ERIC Educational Resources Information Center

    Wyatt, Jeffrey N.; Mattern, Krista D.

    2011-01-01

    The College Board offers fee reductions to students based on eligibility for free and reduced-price lunch in an attempt to introduce the benefits of AP® Exam participation to students most at risk in the education system. This report examined college outcomes of low-SES students with a focused investigation comparing students who took an AP Exam…

  7. Exploring College Outcomes for Low-Income AP® Exam Takers with Fee Reductions. Research Report 2016-2

    ERIC Educational Resources Information Center

    Godfrey, Kelly E.; Wyatt, Jeffrey N.; Beard, Jonathan J.

    2016-01-01

    The focus of this study is to explore college outcomes for students who come from traditionally lower-income backgrounds, reporting a household income of $30,000 or less, and who were awarded a fee reduction to take one or more Advanced Placement® (AP®) Exams, compared to students with a similar background and ability who did not participate in an…

  8. National Survey To Validate General Growth Outcomes for Children between Birth and Age Eight: Initial Results. Technical Report #3.

    ERIC Educational Resources Information Center

    McConnell, Scott; McEvoy, Mary; Carta, Judith J.; Greenwood, Charles R.; Kaminski, Ruth; Good, Roland H., III; Shinn, Mark

    This monograph reports on a national mail survey to validate a set of general growth outcomes for children, including those with disabilities, between birth and age 8. The survey was part of a 5-year project to create a comprehensive measurement system to track the developmental progress of individual children with disabilities in this age range…

  9. Patient-Reported Outcome Results From the Open-Label Phase III AURELIA Trial Evaluating Bevacizumab-Containing Therapy for Platinum-Resistant Ovarian Cancer

    PubMed Central

    Stockler, Martin R.; Hilpert, Felix; Friedlander, Michael; King, Madeleine T.; Wenzel, Lari; Lee, Chee Khoon; Joly, Florence; de Gregorio, Nikolaus; Arranz, José Angel; Mirza, Mansoor Raza; Sorio, Roberto; Freudensprung, Ulrich; Sneller, Vesna; Hales, Gill; Pujade-Lauraine, Eric

    2014-01-01

    Purpose To determine the effects of bevacizumab on patient-reported outcomes (PROs; secondary end point) in the AURELIA trial. Patients and Methods Patients with platinum-resistant ovarian cancer were randomly assigned to chemotherapy alone (CT) or with bevacizumab (BEV-CT). PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Ovarian Cancer Module 28 (EORTC QLQ-OV28) and Functional Assessment of Cancer Therapy–Ovarian Cancer symptom index (FOSI) at baseline and every two or three cycles (8/9 weeks) until disease progression. The primary PRO hypothesis was that more patients receiving BEV-CT than CT would achieve at least a 15% (≥ 15-point) absolute improvement on the QLQ-OV28 abdominal/GI symptom subscale (items 31-36) at week 8/9. Patients with missing week 8/9 questionnaires were included as unimproved. Questionnaires from all assessments until disease progression were analyzed using mixed-model repeated-measures (MMRM) analysis. Sensitivity analyses were used to determine the effects of differing assumptions and methods for missing data. Results Baseline questionnaires were available from 89% of 361 randomly assigned patients. More BEV-CT than CT patients achieved a ≥ 15% improvement in abdominal/GI symptoms at week 8/9 (primary PRO end point, 21.9% v 9.3%; difference, 12.7%; 95% CI, 4.4 to 20.9; P = .002). MMRM analysis covering all time points also favored BEV-CT (difference, 6.4 points; 95% CI, 1.3 to 11.6; P = .015). More BEV-CT than CT patients achieved ≥ 15% improvement in FOSI at week 8/9 (12.2% v 3.1%; difference, 9.0%; 95% CI, 2.9% to 15.2%; P = .003). Sensitivity analyses gave similar results and conclusions. Conclusion Bevacizumab increased the proportion of patients achieving a 15% improvement in patient-reported abdominal/GI symptoms during chemotherapy for platinum-resistant ovarian cancer. PMID:24687829

  10. Student Outcomes: Investigating Competency-Based Curriculum in Adult Basic Education. Research Report No. 5.

    ERIC Educational Resources Information Center

    Hazell, Pat

    The outcomes attained by Australian adults enrolled in competency-based Certificate in Adult Foundation Education (CAFE) courses were examined. Special attention was paid to the outcomes achieved by students in the two lowest of the CAFE program's four levels. The main data sources were as follows: literature review; enrollment data from the…

  11. Longitudinal Assessment of Comprehensive School Reform Program Implementation and Outcomes: First-Year Report

    ERIC Educational Resources Information Center

    Tushnet, Naida C., Flaherty, John, Jr., Smith, And

    2004-01-01

    The Longitudinal Assessment of Comprehensive School Reform Implementation and Outcomes (LACIO) responds to the No Child Left Behind Act's requirement for an evaluation of the federal Comprehensive School Reform (CSR) program. The legislation stipulates two broad goals for the evaluation: (1) to evaluate the implementation and outcomes achieved by…

  12. Relationship of gender and eating disorder symptoms to reported cravings for food: construct validation of state and trait craving questionnaires in Spanish.

    PubMed

    Cepeda-Benito, Antonio; Fernandez, Mari Carmen; Moreno, Silvia

    2003-02-01

    Using confirmatory factor analysis, we cross-validated the factor structures of the Spanish versions of the State and Trait Food Cravings Questionnaires (FCQ-S and FCQ-T; ) in a sample of 304 Spanish college students. Controlling for eating disorder symptoms and food deprivation, scores on the FCQ-T were higher for women than for men, but no sex differences were observed on the FCQ-S. Eating disorder symptomatology was predictive of trait cravings, whereas food deprivation was predictive state cravings. Trait cravings, but not state cravings, were more strongly associated to symptoms of anorexia and bulimia nervosa than with other psychopathology. We suggest that cravings can be conceptualized as multidimensional motivational states and that our data support the hypothesis that food cravings are strongly associated with symptoms of bulimia nervosa.

  13. Cross-cultural development and psychometric evaluation of a patient-reported health-related quality of life questionnaire for adults with haemophilia.

    PubMed

    Rentz, A; Flood, E; Altisent, C; Bullinger, M; Klamroth, R; Garrido, R P; Scharrer, I; Schramm, W; Gorina, E

    2008-09-01

    Co-morbidities of haemophilia, such as arthropathy and blood-borne infections, can adversely affect the quality of life of adult patients with haemophilia. The purpose of this study was to develop and validate a haemophilia-specific health-related quality of life questionnaire for adults (HAEMO-QoL-A). Subjects with varying severities of haemophilia completed the HAEMO-QoL-A at baseline and 4 weeks. Other assessments included the SF-36 and Health Assessment Questionnaire - Functional Disability Index (HAQ-FDI). Two-hundred and twenty-one participants completed the 41-item HAEMO-QoL-A covering six domains (Physical Functioning, Role Functioning, Worry, Consequences of Bleeding, Emotional Impact and Treatment Concerns) and four independent items. Internal consistency was good-to-excellent (Cronbach's alpha-range: 0.75-0.95). Test-retest reproducibility was good, with intraclass correlation coefficients >0.80 except for the Emotional Impact domain (0.79). Concurrent validity between the HAEMO-QoL-A total and subscale scores and all SF-36 subscale scores were generally good (correlations range: 0.13-0.87). Significant correlations between the HAEMO-QoL-A and the HAQ-FDI ranged from -0.14 to -0.69. There were non-significant correlations with the Treatment Concerns subscale and with the Worry subscale. The HAEMO-QoL-A discriminated significantly between adults with haemophilia by severity and HIV status. The Physical Functioning subscale discriminated between patients receiving prophylactic or on-demand therapy. The HAEMO-QoL-A is a valid and reliable instrument for assessing quality of life in haemophilia patients.

  14. Comparison of psychometric properties between usual-week and past-week self-reported physical activity questionnaires: a systematic review.

    PubMed

    Doma, Kenji; Speyer, Renée; Leicht, Anthony S; Cordier, Reinie

    2017-01-31

    The aim was to critically appraise the methodological quality of studies and determine the psychometric qualities of Past-week and Usual-week Physical Activity Questionnaires (PAQs). Data sources were obtained from Pubmed and Embase. The eligibility criteria for selecting studies included: 1) at least one psychometric property of PAQs was examined in adults; 2) the PAQs either had a recall period of usual 7-days (Usual-week PAQs) within the past 12 months or during the past 7-days (Past-week PAQs); and 3) PAQs were self-administered. Study quality was evaluated using the COSMIN taxonomy and the overall psychometric qualities evaluated using pre-established psychometric criteria. Overall, 45 studies were reviewed to assess the psychometric properties of 21 PAQs with the methodological quality of most studies showing good to excellent ratings. When the relationship between PAQs and other instruments (i.e., convergent validity) were compared between recall methods, Past-week PAQs appeared to have stronger correlations than Usual-week PAQs. For the overall psychometric quality, the Incidental and Planned Exercise Questionnaire for the Usual-week (IPEQ-WA) and for the Past-week (IPEQ-W) had the greatest number of positive ratings. For all included PAQs, very few psychometric properties were assessed with poor ratings for the majority of the overall qualities of psychometric properties indicating the limitation of current PAQs. More research that covers a greater spectrum of psychometric properties is required to gain a better understanding of the qualities of current PAQs.

  15. Progress towards a core set of outcome measures in small-vessel vasculitis. Report from OMERACT 9.

    PubMed

    Merkel, Peter A; Herlyn, Karen; Mahr, Alfred D; Neogi, Tuhina; Seo, Philip; Walsh, Michael; Boers, Maarten; Luqmani, Raashid

    2009-10-01

    The past decade has seen a substantial increase in the number and quality of clinical trials of new therapies for vasculitis, including randomized, controlled, multicenter trials that have successfully incorporated measures of disease activity and toxicity. However, because current treatment regimens for severe disease effectively induce initial remission and reduce mortality, future trials will focus on any of several goals including: (a) treatment of mild-moderate disease; (b) prevention of chronic damage; (c) reduction in treatment toxicity; or (d) more subtle differences in remission induction or maintenance. Thus, new trials will require outcome measure instruments that are more precise and are better able to detect effective treatments for different disease states and measure chronic manifestations of disease. The OMERACT Vasculitis Working Group comprises international clinical investigators with expertise in vasculitis who, since 2002, have worked collaboratively to advance the refinement of outcome measures in vasculitis, create new measures to address domains of illness not covered by current research approaches, and harmonize outcome assessment in vasculitis. The focus of the OMERACT group to date has been on outcome measures in small-vessel vasculitis with an overall goal of creating a core set of outcome measures for vasculitis, each of which fulfills the OMERACT filter of truth, discrimination, feasibility, and identifying additional domains requiring further research. This process has been informed by several ongoing projects providing data on outcomes of disease activity, disease-related damage, multidimensional health-related quality of life, and patient-reported ratings of the burden of vasculitis.

  16. The case for an international patient-reported outcomes measurement information system (PROMIS®) initiative.

    PubMed

    Alonso, Jordi; Bartlett, Susan J; Rose, Matthias; Aaronson, Neil K; Chaplin, John E; Efficace, Fabio; Leplège, Alain; Lu, Aiping; Tulsky, David S; Raat, Hein; Ravens-Sieberer, Ulrike; Revicki, Dennis; Terwee, Caroline B; Valderas, Jose M; Cella, David; Forrest, Christopher B

    2013-12-20

    Patient-reported outcomes (PROs) play an increasingly important role in clinical practice and research. Modern psychometric methods such as item response theory (IRT) enable the creation of item banks that support fixed-length forms as well as computerized adaptive testing (CAT), often resulting in improved measurement precision and responsiveness. Here we describe and discuss the case for developing an international core set of PROs building from the US PROMIS® network.PROMIS is a U.S.-based cooperative group of research sites and centers of excellence convened to develop and standardize PRO measures across studies and settings. If extended to a globa