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Sample records for reported outcome questionnaires

  1. 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

  2. Patient experiences with oily skin: The qualitative development of content for two new patient reported outcome questionnaires

    PubMed Central

    Arbuckle, Robert; Atkinson, Mark J; Clark, Marci; Abetz, Linda; Lohs, Jan; Kuhagen, Ilka; Harness, Jane; Draelos, Zoe; Thiboutot, Diane; Blume-Peytavi, Ulrike; Copley-Merriman, Kati

    2008-01-01

    Objective To develop the content for two new patient reported outcome (PRO) measures to: a) assess the severity of symptoms; and b) the impact of facial skin oiliness on emotional wellbeing using qualitative data from face to face, and internet focus groups in Germany and the US. Methods Using input from initial treatment satisfaction focus groups (n = 42), a review of relevant literature and expert clinicians (n = 3), a discussion guide was developed to guide qualitative inquiry using Internet focus groups (IFGs). IFGs were conducted with German (n = 26) and US (n = 28) sufferers of oily skin. Questionnaire items were generated using coded transcript data from the focus groups. Cognitive debriefing was conducted online with 42 participants and face to face with an additional five participants to assess the comprehension of the items. Results There were equal numbers of male and female participants; mean age was 35.4 (SD 9.3) years. On average, participants had had oily skin for 15.2 years, and 74% (n = 40) reported having mild-moderate acne. Participants reported using visual, tactile and sensory (feel without touching their face) methods to evaluate the severity of facial oiliness. Oily facial skin had both an emotional and social impact, and was associated with feelings of unattractiveness, self-consciousness, embarrassment, irritation and frustration. Items were generated for a measure of oily skin severity (Oily Skin Self-Assessment Scale) and a measure of the impact of oily skin on emotional well-being (Oily Skin Impact Scale). Cognitive debriefing resulted in minor changes to the draft items and confirmed their face and content validity. Conclusion The research provides insight into the experience of having oily skin and illustrates significant difficulties associated with the condition. Item content was developed for early versions of two PRO measures of the symptoms and emotional impact of oily facial skin. The psychometric validation of these measures

  3. High Concordance between Self-Reported Adherence, Treatment Outcome and Satisfaction with Care Using a Nine-Item Health Questionnaire in InfCareHIV

    PubMed Central

    Marrone, Gaetano; Mellgren, Åsa; Eriksson, Lars E.; Svedhem, Veronica

    2016-01-01

    Background In this cross-sectional study we present an integrated analysis of a self-reported Health Questionnaire and socio-demographic and treatment outcome data from the national Swedish HIV cohort, InfCareHIV. Objectives To evaluate the Health Questionnaire and identify the main determinants of adherence. Methods A total of 2,846 patients answered a nine-item disease-specific Health Questionnaire between 2012 and 2014, corresponding to 44% of all active patients in the national InfCareHIV cohort. The questionnaire assessed patient related outcome measures (PROMs) regarding health and antiretroviral treatment (ART) and patient related experience measures (PREMs) regarding involvement in care and satisfaction with the care provider. Result We found the Health Questionnaire to be valid and reliable when used in ordinary clinical practice. There was a high concordance between self-reported adherence to ART in the past seven days and treatment outcome, with 94% of patients who reported optimal adherence having a viral load <50 copies/ml. The main determinants of optimal adherence were heterosexual transmission path, being born in Sweden, being male, not reporting experience of ART side effects and being fully satisfied with care. Conclusion The nine-item Health Questionnaire can identify patients at risk of treatment failure, those in need of clinical assessment of adverse events and those with impaired physical health. PMID:27310201

  4. Change trajectories for the Youth Outcome Questionnaire self-report: identifying youth at risk for treatment failure.

    PubMed

    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. Expected change trajectories served as the basis for a warning system designed to identify cases at risk for treatment failure. Tests of the predictive accuracy of the warning system yielded moderately high sensitivity rates for both youth self-report and parent-report measures. Incorporating data from multiple sources (youth, parents, and others) yielded the highest sensitivity in identifying at-risk cases. Results emphasize the importance of using empirically derived methods for identifying youth at risk for negative outcomes in usual care. PMID:20419571

  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. Is Real-Time Feedback of Burn-Specific Patient-Reported Outcome Measures in Clinical Settings Practical and Useful? A Pilot Study Implementing the Young Adult Burn Outcome Questionnaire.

    PubMed

    Ryan, Colleen M; Lee, Austin F; Kazis, Lewis E; Shapiro, Gabriel D; Schneider, Jeffrey C; Goverman, Jeremy; Fagan, Shawn P; Wang, Chao; Kim, Julia; Sheridan, Robert L; Tompkins, Ronald G

    2016-01-01

    Long-term follow-up care of survivors after burn injuries can potentially be improved by the application of patient-reported outcome measures (PROMs). PROMs can inform clinical decision-making and foster communication between the patient and provider. There are no previous reports using real-time, burn-specific PROMs in clinical practice to track and benchmark burn recovery over time. This study examines the feasibility of a computerized, burn-specific PROM, the Young Adult Burn Outcome Questionnaire (YABOQ), with real-time benchmarking feedback in a burn outpatient practice. The YABOQ was redesigned for formatting and presentation purposes using images and transcribed to a computerized format. The redesigned questionnaire was administered to young adult burn survivors (ages 19-30 years, 1-24 months from injury) via an ipad platform in the office before outpatient visits. A report including recovery curves benchmarked to a nonburned relatively healthy age-matched population and to patients with similar injuries was produced for the domains of physical function and social function limited by appearance. A copy of the domain reports as well as a complete copy of the patient's responses to all domain questions was provided for use during the clinical visit. Patients and clinicians completed satisfaction surveys at the conclusion of the visit. Free-text responses, included in the satisfaction surveys, were treated as qualitative data adding contextual information about the assessment of feasibility. Eleven patients and their providers completed the study for 12 clinical visits. All patients found the ipad survey and report "easy" or "very easy" to use. In nine instances, patients "agreed" or "strongly agreed" that it helped them communicate their situation to their doctor/nurse practitioner. Patients "agreed" or "strongly agreed" that the report helped them understand their course of recovery in 10 visits. In 11 visits, the patients "agreed" or "strongly agreed" that

  9. Is Real-Time Feedback of Burn-Specific Patient-Reported Outcome Measures in Clinical Settings Practical and Useful? A Pilot Study Implementing the Young Adult Burn Outcome Questionnaire.

    PubMed

    Ryan, Colleen M; Lee, Austin F; Kazis, Lewis E; Shapiro, Gabriel D; Schneider, Jeffrey C; Goverman, Jeremy; Fagan, Shawn P; Wang, Chao; Kim, Julia; Sheridan, Robert L; Tompkins, Ronald G

    2016-01-01

    Long-term follow-up care of survivors after burn injuries can potentially be improved by the application of patient-reported outcome measures (PROMs). PROMs can inform clinical decision-making and foster communication between the patient and provider. There are no previous reports using real-time, burn-specific PROMs in clinical practice to track and benchmark burn recovery over time. This study examines the feasibility of a computerized, burn-specific PROM, the Young Adult Burn Outcome Questionnaire (YABOQ), with real-time benchmarking feedback in a burn outpatient practice. The YABOQ was redesigned for formatting and presentation purposes using images and transcribed to a computerized format. The redesigned questionnaire was administered to young adult burn survivors (ages 19-30 years, 1-24 months from injury) via an ipad platform in the office before outpatient visits. A report including recovery curves benchmarked to a nonburned relatively healthy age-matched population and to patients with similar injuries was produced for the domains of physical function and social function limited by appearance. A copy of the domain reports as well as a complete copy of the patient's responses to all domain questions was provided for use during the clinical visit. Patients and clinicians completed satisfaction surveys at the conclusion of the visit. Free-text responses, included in the satisfaction surveys, were treated as qualitative data adding contextual information about the assessment of feasibility. Eleven patients and their providers completed the study for 12 clinical visits. All patients found the ipad survey and report "easy" or "very easy" to use. In nine instances, patients "agreed" or "strongly agreed" that it helped them communicate their situation to their doctor/nurse practitioner. Patients "agreed" or "strongly agreed" that the report helped them understand their course of recovery in 10 visits. In 11 visits, the patients "agreed" or "strongly agreed" that

  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 Bilevel Structure of the Outcome Questionnaire-45

    ERIC Educational Resources Information Center

    Bludworth, Jamie L.; Tracey, Terence J. G.; Glidden-Tracey, Cynthia

    2010-01-01

    The structure of the Outcome Questionnaire-45 (Lambert et al., 2001) was examined in a sample of 1,100 university counseling center clients using confirmatory factor analysis. Specifically, the relative fit of 1-factor, 3-factor orthogonal, 3-factor oblique, 4-factor hierarchical, and 4-factor bilevel models were examined. Although the 3-factor…

  12. 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.

  13. 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

  14. Patient-reported outcomes in primary care patients with COPD: psychometric properties and usefulness of the Clinical COPD Questionnaire (CCQ). A cross-sectional study

    PubMed Central

    Pommer, Antoinette M; Pouwer, François; Denollet, Johan; Meijer, Jan-Willem; Pop, Victor J

    2014-01-01

    Background: Chronic obstructive pulmonary disease (COPD) is a common disease with considerable consequences for patients’ daily lives. The Clinical COPD Questionnaire (CCQ) was designed to measure these consequences in daily practice. Although the CCQ is widely used, its original structure has never been tested. Aims: This study examines the psychometric properties of the CCQ with regard to its latent structure in a sample of primary care patients with COPD. Methods: Two cross-sectional studies were conducted; in study 1 (N=243) exploratory analyses, including exploratory factor analysis (EFA) and Mokken scale analysis, were performed to explore the latent structure of the CCQ. In study 2 (N=244), confirmatory factor analysis (CFA) was conducted to evaluate the model fit of the structure found in study 1. Results: Both EFA and Mokken scale analysis revealed a structure of two dimensions (‘general impact’ α=0.91 and ‘cough’ α=0.84). This structure, however, was not confirmed in study 2, nor was the original structure. However, subsequently removing items that violated the assumption of a normal response distribution did result in an excellent model fit with two dimensions measuring ‘dyspnoea’ and ‘cough’ (CFA: comparative fit index (CFI) 0.98; normed fit index (NFI) 0.97; root mean squared error of approximation (RMSEA) 0.08 (0.04)). Conclusions: In primary care, factor analyses on the CCQ revealed a two-component structure measuring ‘general impact’, and ‘cough’. A shortened and more specific version of the CCQ could be regarded as a useful instrument to screen for exacerbations by measuring dyspnoea, coughing and producing phlegm. PMID:25030777

  15. 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

  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. The European solar physics community: outcome from a questionnaire

    NASA Astrophysics Data System (ADS)

    Parenti, Susanna

    2002-12-01

    At the SPM10 meeting held in Prague, for the first time was organized a "young section" which was dedicated to "the career in Solar Physics" (Aulanier, this issue). Prior to the meeting a questionnaire was distributed to the community with the aim to build statistic on the career. The informations collected in this way relate to personal and professional aspects of the career, how much the countries' policy and the working environment can affect it. Moreover, particular attention was given to the PhD and post-doctorate (post-doc) conditions. From the statistics it comes clear that the European Solar Physics is having a difficult period. Besides the main problems, we found the lack of an integrated European community, the lack of permanent positions, the low salary and the lost of popularity among students. Several ideas were proposed to improve the situation.

  18. Proxy-reported questionnaires for young children with asthma: a structured review.

    PubMed

    Barrett, Amy; Clark, Marci; Demuro, Carla; Esser, Dirk

    2013-08-01

    Which proxy-reported outcome measures have been developed for use with children aged 6 years and younger to assess asthma symptoms, asthma control, and asthma-specific health-related quality of life, and do these questionnaires' measurement properties support their use as end-points in clinical trials? A two-phase literature search was conducted: 1) studies describing relevant questionnaires were identified, and the questionnaires were assessed against predefined criteria; 2) studies providing information on the measurement properties of questionnaires meeting the predefined inclusion criteria were identified. Literature sources included PubMed and EMBASE databases, scientific conference proceedings, a clinical trial registry, and a quality of life instrument database. The initial search of literature databases and conference abstracts identified 631 records. 20 paediatric asthma proxy-reported outcome instruments were identified; seven met the inclusion criteria: Childhood Asthma Control Test, Control de Asma en Niños Questionnaire, Pediatric Asthma Caregiver Diary, Pediatric Asthma Control Tool, PedsQL 3.0 Short-Form 22 Asthma Module, PedsQL Asthma Symptoms Scale, and Test for Respiratory and Asthma Control in Kids. Three proxy-reported outcome instruments were considered suitable for use as end-points in paediatric asthma clinical trials; the Pediatric Asthma Caregiver Diary possesses the strongest measurement properties of the three.

  19. The Smoking Consequences Questionnaire-Adult: Measurement of Smoking Outcome Expectancies of Experienced Smokers.

    ERIC Educational Resources Information Center

    Copeland, Amy L.; And Others

    1995-01-01

    Two versions of the Smoking Consequences Questionnaire for adults were developed and tested with 407 smokers and nonsmokers. The version with probability items appeared to have greater construct validity than the version with subjective expected utility items. The scale reflects the refinement of smokers' outcome expectancies with experience. (SLD)

  20. 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 outcomes. Data…

  1. 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.

  2. The SF36 health survey questionnaire: an outcome measure suitable for routine use within the NHS?

    PubMed Central

    Garratt, A M; Ruta, D A; Abdalla, M I; Buckingham, J K; Russell, I T

    1993-01-01

    OBJECTIVE--To assess the validity, reliability, and acceptability of the short form 36 (SF 36) health survey questionnaire (a shortened version of a battery of 149 health status questions) as a measure of patient outcome in a broad sample of patients suffering from four common clinical conditions. DESIGN--Postal questionnaire, followed up by two reminders at two week intervals. SETTING--Clinics and four training practices in north east Scotland. SUBJECTS--Over 1700 patients aged 16-86 with one of four conditions--low back pain, menorrhagia, suspected peptic ulcer, or varicose veins--and a comparison sample of 900 members of the general population. MAIN OUTCOME MEASURES--The eight scales within the SF36 health profile. RESULTS--The response rate exceeded 75% in the patient population (1310 respondents). The SF36 satisfied rigorous psychometric criteria for validity and internal consistency. Clinical validity was shown by the distinctive profiles generated for each condition, each of which differed from that in the general population in a predictable manner. Furthermore, SF36 scores were lower in referred patients than in patients not referred and were closely related to general practitioners' perceptions of severity. CONCLUSIONS--These results provide support for the SF36 as a potential measure of patient outcome within the NHS. The SF36 seems acceptable to patients, internally consistent, and a valid measure of the health status of a wide range of patients. Before it can be used in the new health service, however, its sensitivity to changes in health status over time must also be tested. PMID:8518640

  3. Doubtful outcome of the validation of the Rome II questionnaire: validation of a symptom based diagnostic tool

    PubMed Central

    2009-01-01

    Background Questionnaires are used in research and clinical practice. For gastrointestinal complaints the Rome II questionnaire is internationally known but not validated. The aim of this study was to validate a printed and a computerized version of Rome II, translated into Swedish. Results from various analyses are reported. Methods Volunteers from a population based colonoscopy study were included (n = 1011), together with patients seeking general practice (n = 45) and patients visiting a gastrointestinal specialists' clinic (n = 67). The questionnaire consists of 38 questions concerning gastrointestinal symptoms and complaints. Diagnoses are made after a special code. Our validation included analyses of the translation, feasibility, predictability, reproducibility and reliability. Kappa values and overall agreement were measured. The factor structures were confirmed using a principal component analysis and Cronbach's alpha was used to test the internal consistency. Results and Discussion Translation and back translation showed good agreement. The questionnaire was easy to understand and use. The reproducibility test showed kappa values of 0.60 for GERS, 0.52 for FD, and 0.47 for IBS. Kappa values and overall agreement for the predictability when the diagnoses by the questionnaire were compared to the diagnoses by the clinician were 0.26 and 90% for GERS, 0.18 and 85% for FD, and 0.49 and 86% for IBS. Corresponding figures for the agreement between the printed and the digital version were 0.50 and 92% for GERS, 0.64 and 95% for FD, and 0.76 and 95% for IBS. Cronbach's alpha coefficient for GERS was 0.75 with a span per item of 0.71 to 0.76. For FD the figures were 0.68 and 0.54 to 0.70 and for IBS 0.61 and 0.56 to 0.66. The Rome II questionnaire has never been thoroughly validated before even if diagnoses made by the Rome criteria have been compared to diagnoses made in clinical practice. Conclusion The accuracy of the Swedish version of the Rome II is of

  4. Patient-Reported Outcome Questionnaire for Systemic Mastocytosis

    ClinicalTrials.gov

    2015-03-02

    Aggressive Systemic Mastocytosis (ASM); Systemic Mastocytosis With Associated Clonal Hematological Non-mast Cell Lineage Disease (SM-AHNMD); Mast Cell Leukemia (MCL); Smoldering Systemic Mastocytosis (SSM); Indolent Systemic Mastocytosis (ISM) [ISM Subgroup Fully Recruited

  5. [Patient-reported SEFAS: Questionnaire good evaluation method in foot and ankle disorders].

    PubMed

    Cöster, Maria; Rosengren, Björn; Carlsson, Åke; Montgomery, Fredrik; Karlsson, Magnus

    2015-02-10

    There is need for structured evaluation of disability before and after surgery. The patients' subjective aspects of their symptoms should be one part of this evaluation, preferably captured by patient-reported outcome measures (PROMs). There are several PROMs, either generic or region-specific questionnaires, but no » gold standard « for foot or ankle evaluation. We translated the Self-reported Foot and Ankle Score (SEFAS) and evaluated the psychometric properties of the score in terms of reliability, validity and responsiveness in patients with a variety of foot and ankle disorders. In this report we recommend a validation process for PROMs and report that SEFAS shows good results when doing this. As SEFAS is a PROM, the instrument seems suitable for use in national registers.

  6. 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.

  7. Community College Student Experiences Questionnaire. Assessment Report #92-1.

    ERIC Educational Resources Information Center

    South Central Community Coll., New Haven, CT.

    During 1991-92, South Central Community College (SCCC), in Connecticut, administered student experience questionnaires to 600 students who were to graduate in June 1991 or were enrolled in fall 1991 and spring 1992 credit courses. The questionnaire sought information on student background, program of study, courses taken, activities, perceptions…

  8. Reporting Outcomes of Extremely Preterm Births.

    PubMed

    Rysavy, Matthew A; Marlow, Neil; Doyle, Lex W; Tyson, Jon E; Serenius, Frederik; Iams, Jay D; Stoll, Barbara J; Barrington, Keith J; Bell, Edward F

    2016-09-01

    Published reports of extremely preterm birth outcomes provide important information to families, clinicians, and others and are widely used to make clinical and policy decisions. Misreporting or misunderstanding of outcome reports may have significant consequences. This article presents 7 recommendations to improve reporting of extremely preterm birth outcomes in both the primary and secondary literature. The recommendations should facilitate clarity in communication about extremely preterm birth outcomes and increase the value of existing and future work in this area. PMID:27516525

  9. 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.

  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. The Menstrual Joy Questionnaire Items Alone Can Positively Prime Reporting of Menstrual Attitudes and Symptoms

    ERIC Educational Resources Information Center

    Aubeeluck, Aimee; Maguire, Moira

    2002-01-01

    Chrisler, Johnston, Champagne, and Preston (1994) reported that the title of the Menstrual Joy Questionnaire (MJQ) could prime participants to report positive changes on the Menstrual Distress Questionnaire (MDQ) and greater endorsement of "menstruation as a natural event" on the Menstrual Attitudes Questionnaire (MAQ). This study is a partial…

  12. 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.

  13. Patient-reported outcomes in borderline personality disorder

    PubMed Central

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

    2014-01-01

    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. PMID:25152662

  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. 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

  17. 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…

  18. Child Welfare Outcomes, 1998: Annual Report.

    ERIC Educational Resources Information Center

    American Humane Association, Englewood, CO.

    This report is the first in a series of annual reports presenting data on state performance in meeting the needs of children and families who come into contact with the child welfare system, focusing on outcomes for these children. The seven outcomes are: (1) reduce recurrence of child abuse/neglect; (2) reduce incidence of child abuse/neglect in…

  19. Minnesota Family Service Collaboratives: 1998 Outcome Reports.

    ERIC Educational Resources Information Center

    Minnesota Univ., Minneapolis. Center for Applied Research and Educational Improvement.

    In 1993 the Minnesota Legislature provided funding to establish local collaborative initiatives to integrate services and improve outcomes for children and families. This report is based on the individual outcome reports mandated for the 24 collaboratives that first received implementation grants in 1995 or 1996. Information from a variety of…

  20. Outcome Measure of Pain in Patients with Lumbar Disc Herniation: Validation Study of the Iranian version of Pain Sensitivity Questionnaire

    PubMed Central

    Azhari, Shirzad; Shahzadi, Sohrab; Nayeb Aghaei, Hossain; Mohammadi, Hassan Reza; Montazeri, Ali

    2016-01-01

    Study Design Cross-sectional. Purpose To translate and culturally adapt an Iranian version of the Pain Sensitivity Questionnaire (PSQ) in Iran. Overview of Literature Instruments measuring patient reported outcomes should satisfy certain psychometric properties. Methods The PSQ was translated following cross-cultural adaptation guidelines. A total of 101 patients with lumbar disc herniation (LDH), and 39 healthy cases were included in the study. All participants completed the PSQ and the Pain Catastrophizing Scale (PCS). The internal consistency, test-retest reliability, known group comparison, criterion validity and item-scale correlations were assessed. Results The mean age of participants was 51.7 years. Reliability, validity and correlation of PSQ and PCS showed satisfactory results. Cronbach's alpha coefficients were 0.81 for PSQ-total, 0.82 for PSQ-minor, and 0.82 for PSQ-moderate. The intraclass correlation coefficients value was 0.84 (0.616–0.932) indicating an excellent test-retest reliability. The instrument discriminated well between sub-groups of patients who differed in a standard predictive measure of LDH surgery (the Finneson–Cooper score). Total PSQ were also significantly correlated with the total scores of the PCS, lending support to its good convergent validity. Additionally, the correlation of each item with its hypothesized domain on the PSQ indicated acceptable results, suggesting that the items had a substantial relationship with their own domains. Conclusions The adapted Iranian PSQ is a valid and reliable questionnaire for the assessment of pain in patients with LDH. PMID:27340527

  1. 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…

  2. Intensification of the Learning Process: Educational Grouping Questionnaire. A Series of Reports Designed for Classroom Use.

    ERIC Educational Resources Information Center

    Bucks County Public Schools, Doylestown, PA.

    This report consists of a classification of elementary school age children and information concerning an Educational Grouping Questionnaire, which is designed to help the classroom teacher group her students. (See TM 001 368 for example of questionnaire; see TM 001 363 for summary of report; for other related documents, see TM 001 160, 364-366,…

  3. Advances in Patient-Reported Outcomes: The NIH PROMIS® Measures

    PubMed Central

    Broderick, Joan E.; DeWitt, Esi Morgan; Rothrock, Nan; Crane, Paul K.; Forrest, Christopher B.

    2013-01-01

    Patient-reported outcomes (PRO) are questionnaire measures of patients’ symptoms, functioning, and health-related quality of life. They are designed to provide important clinical information that generally cannot be captured with objective medical testing. In 2004, the National Institutes of Health launched a research initiative to improve the clinical research enterprise by developing state-of-the-art PROs. The NIH Patient-Reported Outcomes Measurement System (PROMIS) and Assessment Center are the products of that initiative. Adult, pediatric, and parent-proxy item banks have been developed by using contemporary psychometric methods, yielding rapid, accurate measurements. PROMIS currently provides tools for assessing physical, mental, and social health using short-form and computer-adaptive testing methods. The PROMIS tools are being adopted for use in clinical trials and translational research. They are also being introduced in clinical medicine to assess a broad range of disease outcomes. Recent legislative developments in the United States support greater efforts to include patients’ reports of health experience in order to evaluate treatment outcomes, engage in shared decision-making, and prioritize the focus of treatment. PROs have garnered increased attention by the Food and Drug Administration (FDA) for evaluating drugs and medical devices. Recent calls for comparative effectiveness research favor inclusion of PROs. PROs could also potentially improve quality of care and disease outcomes, provide patient-centered assessment for comparative effectiveness research, and enable a common metric for tracking outcomes across providers and medical systems. PMID:25848562

  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. The Parenting Questionnaire: An Inventory for Assessing Outcomes of Adlerian Parent Groups.

    ERIC Educational Resources Information Center

    Tiffany, Jeanne; Tollefson, Nona

    This study field tests and evaluates the Parenting Questionnaire, an instrument designed to assess parental attitudes and behavior, based on the child-raising theories of Dreikurs and Dinkmeyer and the Adlerian model for parent study groups. Dreikurs and Adler stress the purposive nature of children's behavior or misbehavior, and teach parents to…

  6. 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

  7. Student Learning Outcomes Assessment Reports, 2004

    ERIC Educational Resources Information Center

    Filipp, Laura

    2004-01-01

    This report includes a Maryland statewide analysis, by competency, of student learning outcomes, assessment activities at community colleges, as well as public four-year colleges and universities. The workgroup decide that these reports would focus on each of the five competencies related to general education and essential skills that are…

  8. 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…

  9. 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…

  10. Outcomes of xerostomia-related quality of life for nasopharyngeal carcinoma treated by IMRT: based on the EORTC QLQ-C30 and H&N35 questionnaires.

    PubMed

    Bian, Xiuhua; Song, Tao; Wu, Shixiu

    2015-01-01

    The aim of this study was to review the published literature addressing the question of whether intensity-modulated radiotherapy (IMRT) resulted in an improvement of quality of life (QoL), especially xerostomia-related QoL of all nasopharyngeal carcinoma patients as time progressed. A literature search of PubMed, Embase and Google Scholar was performed, only reports containing original data of the QoL scores after treated by IMRT were included. Two independent reviewers extracted information of study design, study population, interventions, outcome measures and conclusions for each article. The inclusion criteria were met by 14 articles covering outcomes based on the questionnaires treated by IMRT. Data from same questionnaires (European Organization of Research and Treatment of Cancer QLQ-C30 and H&N35 questionnaires) were exacted and we analyzed four items (global health status, dry mouth and sticky saliva, swallowing, social eating and social contact), which have a close relationship with xerostomia-related QoL. Results indicated that a maximal deterioration of most QoL scales including global health status developed during treatment or at the end of the treatment course and then followed by a gradual recovery to 1 year, 1-2 years after IMRT, compared with their baseline level, some specific head and neck items, most in the EORTC QLQ H&N35, remained worse for the surviving patients. In conclusion, the published data reasonably support the benefits of IMRT in improving QoL, but xerostomia-related items still had a significantly negative effect in 2 years to impact a survivor's QoL.

  11. Choosing a patient-reported outcome measure.

    PubMed

    McClimans, Leah M; Browne, John

    2011-02-01

    There has been much philosophical interest regarding the 'hierarchy of evidence' used to determine which study designs are of most value for reporting on questions of effectiveness, prognosis, and so on. There has been much less philosophical interest in the choice of outcome measures with which the results of, say, an RCT or a cohort study are presented. In this paper, we examine the FDA's recently published guidelines for assessing the psychometric adequacy of patient-reported outcome measures. We focus on their recommendations for demonstrating content validity and also for how researchers should weigh up the sum of psychometric evidence when choosing these measures. We argue that questions regarding judgment and understanding meaning of these measures should play a more central role in determining their adequacy.

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

    PubMed

    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

  13. 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

  14. 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…

  15. 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…

  16. 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…

  17. 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…

  18. 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…

  19. 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. PMID:27652219

  20. Electronic patient-reported outcome systems in oncology clinical practice.

    PubMed

    Bennett, Antonia V; Jensen, Roxanne E; Basch, Ethan

    2012-01-01

    Patient-reported outcome (PRO) questionnaires assess topics a patient can report about his or her own health. This includes symptoms (eg, nausea, fatigue, diarrhea, pain, or frequent urination), physical functioning (eg, difficulty climbing stairs or difficulty fastening buttons), and mental health (eg, anxiety, fear, or worry). Electronic PRO (ePRO) systems are used in oncology clinical care because of 1) their ability to enhance clinical care by flagging important symptoms and saving clinicians time; 2) the availability of standardized methods for creating and implementing PROs in clinics; and 3) the existence of user-friendly platforms for patient self-reporting like tablet computers and automated telephone surveys. Many ePRO systems can provide actionable links to clinical care such as summary reports in a patient's electronic medical record and real-time e-mail alerts to providers when patients report acute needs. This review presents 5 examples of ePRO systems currently in use in oncology practice. These systems support multiple clinical activities, including assessment of symptoms and toxicities related to chemotherapy and radiation, postoperative surveillance, and symptom management during palliative care and hospice. Patient self-reporting is possible both at clinical visits and between visits over the Internet or by telephone. The implementation of an ePRO system requires significant resources and expertise, as well as user training. ePRO systems enable regular monitoring of patient symptoms, function, and needs, and can enhance the efficiency and quality of care as well as communication with patients.

  1. 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)

  2. 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

  3. The usefulness of a self-report questionnaire measuring auditory verbal hallucinations.

    PubMed

    Kim, Se Hyun; Jung, Hee Yeon; Hwang, Samuel S; Chang, Jae Seung; Kim, Yeni; Ahn, Yong Min; Kim, Yong Sik

    2010-08-16

    A self-report measure of psychotic symptoms has been considered to be unsuitable due to the possible denial of symptoms in the patients with schizophrenia. However, a self-report questionnaire would be an efficient tool for the evaluation of subjective aspects of auditory verbal hallucination (AVH), which requires further clarification. In this study, a total of 87 patients with schizophrenia took baseline evaluations for Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ), a self-report questionnaire for AVH, and Psychotic Symptom Rating Scales-Auditory Hallucination Subscale (PSYRATS-AH) and an item measuring hallucinations (P3) on Positive and Negative Syndrome Scale for Schizophrenia (PANSS), both interviewer-rated scales for AVH. At 1 week and at 6 months post-baseline, 39 and 68 patients repeated HPSVQ and PSYRATS-AH, respectively. Total scores on HPSVQ showed good agreement with those on PSYRATS-AH and PANSS, Item P3, and HPSVQ showed good test-retest reliability and internal consistency. In addition, the changes in total scores of HPSVQ during 6-month follow-up were also highly correlated to those of PSYRATS-AH. The findings of factor analysis and hierarchical cluster analysis suggested that the items addressing emotional characteristics of AVH constituted one factor and that the remaining items, primarily concerning the physical characteristics, combined to form another factor. Taken together, the HPSVQ, a self-report questionnaire measuring AVH, was characterized by good psychometric properties, which suggests the appropriateness of a self-report scale for examining the internal structure of AVH in patients with schizophrenia. PMID:20472012

  4. Clinical Assessment of Affective Instability: Comparing EMA indices, questionnaire reports, and retrospective recall

    PubMed Central

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

    2010-01-01

    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 affective instability in psychiatric outpatients either with a borderline personality diagnosis (BPD; n=58) or with a current major depressive episode or dysthymia (MDD/DYS; n=42). We examined the agreement of three trait measures of affective instability (Personality Assessment Inventory-Borderline Features scale – Affective Instability scale, Affect Intensity Measure, and the Affect Lability Scales) and one retrospective mood recall task with EMA indices of mood and mood instability. Results indicate only modest to moderate agreement between momentary and questionnaire assessments of trait affective instability; agreement between recalled mood changes and EMA indices was poor. Implications for clinical research and practice and possible applications of EMA methodology are discussed. PMID:19719353

  5. A review of self-report medication side effect questionnaires for mental health patients.

    PubMed

    Ashoorian, Deena; Davidson, Rowan; Rock, Daniel; Gudka, Sajni; Clifford, Rhonda

    2014-11-30

    Side effects of psychotropic medications are important determinants of adherence to treatment. Discussion between the patient and clinician facilitated through the use of a side effect self-report questionnaire (SRQ) could lead to improved communications and treatment adherence. The aim of this review was to 1) identify all currently available side effect SRQs used in the assessment of mental health patients' subjective experiences, 2) evaluate the characteristics of the studies and 3) assess the psychometric properties of each of the questionnaires. Eight electronic databases were searched for peer-reviewed published articles. Six side effect SRQs were identified. Two independent reviewers assessed the quality of the study designs and psychometric properties of the identified SRQs. All questionnaires consisted of closed questions relating to antipsychotic side effects and completion times ranged from 5 to 20 min. Five questionnaires had undergone some form of psychometric testing, ranging from basic to comprehensive. There is a need in everyday clinical practice for a side effect communication tool applicable to all psychotropic medications, which allows the patient to express their subjective beliefs about their medications. This could provide an important contribution to the working relationship between patients and clinicians leading to informed decision-making and improved adherence.

  6. 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…

  7. The Toddler Language and Motor Questionnaire: A mother-report measure of language and motor development.

    PubMed

    Gudmundsson, Einar

    2015-01-01

    This study empirically evaluates the psychometric properties of a new mother-answered developmental instrument for toddlers, the Toddler Language and Motor Questionnaire (TLMQ). Mothers of 1132 15- to 38-month-old children filled out a 144-item instrument, tapping the toddlers' competences in five language and motor subtests. Concurrent validity was investigated in an independent sample by administering the McCarthy Scales of Children's Abilities (MSCA) individually to 47 children and the TLMQ to their mothers. A two-factor solution emerged in principal axis factor analyses with a promax rotation, with motor subtests loading high on one of the factors and the language subtests on the other. Toddlers' genders significantly affected outcome on all of the five subtests. Divergent and convergent correlations emerged between the TLMQ's motor composite and scales of the MSCA. Partially convergent and divergent correlations emerged between the TLMQ's language composite and scales of the MSCA. The findings show that young children's motor and language development can be reliably and validly assessed by using a psychometrically constructed questionnaire completed by mothers.

  8. A systematic review of patient-reported outcome instruments measuring sleep dysfunction in adults.

    PubMed

    Devine, Emily Beth; Hakim, Zafar; Green, Jesse

    2005-01-01

    Sleep dysfunction can manifest in several ways, ranging from insomnia to somnolence, and from disrupted sleep to lack of restful sleep. Measuring sleep dysfunction is an area of active research and there exist a number of patient-reported outcome instruments that measure various aspects of sleep dysfunction. However, these instruments have not been evaluated systematically. We used a conceptual model of sleep that included four physical domains of general interest to patients and investigators, and cover the breadth of this disorder: sleep initiation; sleep maintenance; sleep adequacy; and somnolence. We next considered the additional health-related quality-of-life (HR-QOL) domains of psychological and social functioning, progressing along the continuum to include health perceptions and opportunity. We then conducted a literature review to identify instruments and, using criteria developed by the Medical Outcomes Trust Scientific Advisory Committee, evaluated these instruments for their potential use in measuring sleep dysfunction. Twenty-two instruments were identified. Six instruments were found to include the four physical domains defined a priori (Basic Nordic Sleep Questionnaire, Leeds Sleep Evaluation Questionnaire, Medical Outcomes Study - Sleep Problems Measures, Pittsburgh Sleep Diary, Pittsburgh Sleep Quality Index, Self-Rated Sleep Questionnaire and the Sleep Dissatisfaction Questionnaire). Several additional instruments addressed at least some of the domains and thus may be useful for specific purposes. A few instruments addressed overall HR-QOL, but did not include all four domains of interest (Functional Outcomes of Sleep Questionnaire, Quality of Life in Insomniacs and the Sleep-Wake Activity Inventory). Two instruments had undergone extensive psychometric evaluation (Medical Outcomes Study - Sleep Problems Measures and Pittsburgh Sleep Quality Index), with only the latter reporting information about interpretability. Our review indicates that

  9. Gender, ethnicity and graduate status, and junior doctors’ self-reported preparedness for clinical practice: national questionnaire surveys

    PubMed Central

    Svirko, Elena; Lambert, Trevor; Goldacre, Michael J

    2014-01-01

    Objectives Medical schools need to ensure that graduates feel well prepared for their first medical job. Our objective was to report on differences in junior doctors’ self-reported preparedness for work according to gender, ethnicity and graduate status. Design Postal and electronic questionnaires. Setting UK. Participants Medical graduates of 2008 and 2009, from all UK medical schools, one year after graduation. Main outcome measures The main outcome measure was the doctors’ level of agreement with the statement that ‘My experience at medical school prepared me well for the jobs I have undertaken so far’, to which respondents were asked to reply on a scale from ‘strongly agree’ to ‘strongly disagree’. Results Women were slightly less likely than men to agree that they felt well prepared for work (50% of women agreed or strongly agreed vs. 54% of men), independently of medical school, ethnicity, graduate entry status and intercalated degree status, although they were no more likely than men to regard lack of preparedness as having been a problem for them. Adjusting for the other subgroup differences, non-white respondents were less likely to report feeling well prepared than white (44% vs. 54%), and were more likely to indicate that lack of preparedness was a problem (30% non-white vs. 24% white). There were also some gender and ethnic differences in preparedness for specific areas of work. Conclusions The identified gender and ethnic differences need to be further explored to determine whether they are due to differences in self-confidence or in actual preparedness. PMID:24108533

  10. Clinical assessment of affective instability: comparing EMA indices, questionnaire reports, and retrospective recall.

    PubMed

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

    2009-09-01

    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 affective instability in psychiatric outpatients either with a borderline personality diagnosis (n = 58) or with a current episode of major depressive disorder or dysthymia (n = 42). The authors examined the agreement of 3 trait measures of affective instability-the Affective Instability subscale of the Personality Assessment Inventory-Borderline Features scale (L. C. Morey, 1991), the Affect Intensity Measure (R. J. Larsen, E. Diener, & R. Emmons, 1986), and the Affect Lability Scales (P. D. Harvey, B. R. Greenberg, & M. R. Serper, 1989)-and 1 retrospective mood recall task with EMA indices of mood and mood instability. Results indicate only modest to moderate agreement between momentary and questionnaire assessments of trait affective instability; agreement between recalled mood changes and EMA indices was poor. Implications for clinical research and practice and possible applications of EMA methodology are discussed.

  11. 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…

  12. Retrospective assessment of behavioral inhibition in infants and toddlers: development of a parent report questionnaire.

    PubMed

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

    2013-02-01

    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 inhibition in infants and toddlers. Principal Component Analysis of the Retrospective Infant Behavioral Inhibition Scale (RIBI) supported a three factor solution of the core features of BI in two unselected samples. Internal consistency and inter-rater agreement of both parent judgments were >.90 and >.70. Scores of the RIBI were positively correlated with the parent report temperament questionnaire IBQ and a laboratory-based test at age 14 months with the child. PMID:22798203

  13. 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

  14. Patient-Reported Outcome Measures in Systemic Sclerosis (Scleroderma).

    PubMed

    Pellar, Russell E; Tingey, Theresa M; Pope, Janet Elizabeth

    2016-05-01

    Scleroderma (systemic sclerosis) is a rare autoimmune connective tissue disease that can damage multiple organs and reduce quality of life. Patient-reported outcome measures capture the patient's perspective. Some measures are specific to systemic sclerosis and others are general. Patient-reported outcomes in systemic sclerosis are important to aid in understanding the impact of systemic sclerosis on patients. PMID:27133491

  15. [Patient-reported and patient-weighted outcomes in ophthalmology].

    PubMed

    Scheibler, F; Finger, R P; Grosselfinger, R; Dintsios, C-M

    2010-03-01

    Considering patients' values and preferences in comparative effectiveness research (CER) is one of the main challenges in ophthalmology (value-based medicine). This article defines core terms in CER. The concept of patient-relevant (or patient-important) outcomes is distinguished from patient-reported outcomes (PRO) by means of examples in the field of ophthalmology. In order to be able to give a consistant recommendation if an intervention leads to conflicting results for different outcomes (trade-off), a ranking of outcomes will be necessary. Examples of studies in glaucoma patients are provided that demonstrate the possibilities of ranking of outcomes based on patient preferences. PMID:20024566

  16. Symptoms of depression as reported by Norwegian adolescents on the Short Mood and Feelings Questionnaire

    PubMed Central

    Lundervold, Astri J.; Breivik, Kyrre; Posserud, Maj-Britt; Stormark, Kjell Morten; Hysing, Mari

    2013-01-01

    The present study investigated sex-differences in reports of depressive symptoms on a Norwegian translation of the short version of the Mood and Feelings Questionnaire (SMFQ). The sample comprised 9702 Norwegian adolescents (born 1993–1995, 54.9% girls), mainly attending highschool. A set of statistical analyses were run to investigate the dimensionality of the SMFQ. Girls scored significantly higher than boys on the SMFQ and used the most severe response-category far more frequently. Overall, the statistical analyses supported the essential unidimensionality of SMFQ. However, the items with the highest loadings according to the bifactor analysis, reflecting problems related to tiredness, restlessness and concentration difficulties, indicated that some of the symptoms may both be independent of and part of the symptomatology of depression. Measurement invariance analysis showed that girls scored slightly higher on some items when taking the latent variable into account; girls had a lower threshold for reporting mood problems and problems related to tiredness than boys, who showed a marginally lower threshold for reporting that no-one loved them. However, the effect on the total SMFQ score was marginal, supporting the use of the Norwegian translation of SMFQ as a continuous variable in further studies of adolescents. PMID:24062708

  17. Institutional Outcomes Report, 2002-2003.

    ERIC Educational Resources Information Center

    William Rainey Harper Coll., Palatine, IL. Office of Planning and Research.

    This document presents the institutional outcomes for 2002-2003 for William Rainey Harper College. The document begins with the Presidents Introduction, which includes a list of accomplishments of the college. Some of these success are: (1) 90% retention rates for students involved in retention services and programs; (2) achieving a hiring…

  18. The Perception of Procedures Questionnaire: psychometric properties of a brief parent report measure of procedural distress.

    PubMed

    Kazak, A E; Penati, B; Waibel, M K; Blackall, G F

    1996-04-01

    Reported the reliability and validity of the Perception of Procedures Questionnaire (PPQ), a 19-item parent-report measure developed to assess child and parent distress related to lumbar punctures and bone marrow aspirates in the diagnosis and treatment of childhood cancer. PPQ data from 140 mothers and 96 fathers of children and adolescents with leukemia in a first remission were analyzed separately. Factor analyses yielded five factors for mothers and fathers: Parent Satisfaction; Child Distress: During; Child Distress: Before; Parent Distress; and Parent Involvement. Internal consistency (Cronbach's alpha) was high for the total score and the five factor scores as were interrater reliabilities between mothers and fathers. Validity was determined using the Parenting Stress Index-Short Form, the Pediatric Oncology Quality of Life Scale, and parent and nurse ratings during procedures. Factors 2 and 3, assessing child distress, show strong associations with the validation measures and support the distinction between distress before and during procedures. This developing scale is recommended for use in the assessment and evaluation of child and parent procedure-related distress in pediatric oncology.

  19. 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.

  20. Reported Outcome Measures in Degenerative Cervical Myelopathy: A Systematic Review

    PubMed Central

    McHugh, Maire; Elgheriani, Ali; Kolias, Angelos G.; Tetreault, Lindsay A.; Hutchinson, Peter J. A.; Fehlings, Michael G.; Kotter, Mark R. N.

    2016-01-01

    Objective Degenerative cervical myelopathy [DCM] is a disabling and increasingly prevalent group of diseases. Heterogeneous reporting of trial outcomes limits effective inter-study comparison and optimisation of treatment. This is recognised in many fields of healthcare research. The present study aims to assess the heterogeneity of outcome reporting in DCM as the premise for the development of a standardised reporting set. Methods A systematic review of MEDLINE and EMBASE databases, registered with PROSPERO (CRD42015025497) was conducted in accordance with PRISMA guidelines. Full text articles in English, with >50 patients (prospective) or >200 patients (retrospective), reporting outcomes of DCM were eligible. Results 108 studies, assessing 23,876 patients, conducted world-wide, were identified. Reported outcome themes included function (reported by 97, 90% of studies), complications (reported by 56, 52% of studies), quality of life (reported by 31, 29% of studies), pain (reported by 29, 27% of studies) and imaging (reported by 59, 55% of studies). Only 7 (6%) studies considered all of domains in a single publication. All domains showed variability in reporting. Conclusions Significant heterogeneity exists in the reporting of outcomes in DCM. The development of a consensus minimum dataset will facilitate future research synthesis. PMID:27482710

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

    PubMed

    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 preliminary

  2. 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

  3. 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

  4. The Quantitative Analgesic Questionnaire: A Tool to Capture Patient-Reported Chronic Pain Medication Use

    PubMed Central

    Robinson-Papp, Jessica; George, Mary Catherine; Wongmek, Arada; Nmashie, Alexandra; Merlin, Jessica S.; Ali, Yousaf; Epstein, Lawrence; Green, Mark; Serban, Stelian; Sheth, Parag; Simpson, David M.

    2015-01-01

    Context The extent to which patients take chronic pain medications as prescribed is not well studied, and there are no generally agreed-upon measures. The Quantitative Analgesic Questionnaire (QAQ) is a new instrument designed to comprehensively document patient-reported medication use, generate scores to quantify it (by individual drug, class, and/or overall), and compare it (qualitatively and/or quantitatively) to the regimen as prescribed. Objectives The aim of this study was to describe the development and preliminary validation of the QAQ. Methods The QAQ was studied in a convenience sample of 149 HIV-infected participants. Results We found that the QAQ scores computed for participants’ chronic pain medication regimens were valid based on their correlation with: 1) patient-reported pain intensity (r=0.38, P<0.001); and 2) experienced pain management physicians’ independent quantification of the regimens (r=0.89; P<0.001). The QAQ also demonstrated high inter-rater reliability (r=0.957; P<0.001). Detailed examination of the QAQ data in a subset of 34 participants demonstrated that the QAQ revealed suboptimal adherence in 44% of participants, and contained information that would not have been gleaned from review of the medical record alone in 94%, including use of over-the-counter medications, and quantification of “as needed” dosing. The QAQ also was found to be useful in quantifying change in the medication regimen over time, capturing a change in 50% of the participants from baseline to eight-week follow-up. Conclusion The QAQ is a simple tool that can facilitate understanding of patient-reported chronic pain medication regimens, including calculation of percent adherence and generation of quantitative scores suitable for estimating and tracking change in medication use over time. PMID:25912277

  5. 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…

  6. Knotted stents: Case report and outcome analysis

    PubMed Central

    Lee, Ha Na; Hwang, Hokyeong

    2015-01-01

    A knotted ureteral stent is an extremely rare condition, with fewer than 20 cases reported in the literature; however, it is difficult to treat. We report a case in which a folded Terumo guidewire was successfully used to remove a knotted stent percutaneously without anesthesia. We also review the current literature on predisposing factors and management strategies for knotted ureteral stents. PMID:25964843

  7. The Use of the Position Analysis Questionnaire (PAQ) for Establishing the Job Component Validity of Tests. Report No. 5. Final Report.

    ERIC Educational Resources Information Center

    McCormick, Ernest J.; And Others

    The Position Analysis Questionnaire (PAQ), a structured job analysis questionnaire that provides for the analysis of individual jobs in terms of each of 187 job elements, was used to establish the job component validity of certain commercially-available vocational aptitude tests. Prior to the general analyses reported here, a statistical analysis…

  8. 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

  9. The Perceived Deficits Questionnaire

    PubMed Central

    Binder, Allison; Nikelshpur, Olga M.; Chiaravalloti, Nancy; DeLuca, John

    2016-01-01

    Background: Cognitive dysfunction affects approximately 43% to 70% of individuals with multiple sclerosis (MS) and is an important determinant of several functional outcomes in MS and quality of life. Brief neuropsychological test batteries have been developed specifically for use in MS and are widely used to aid clinicians in assessing levels of cognitive impairment in MS. Neuropsychologists and neurologists also frequently use briefer screening measures, such as the Perceived Deficits Questionnaire (PDQ), to assist in determining whether a more extensive neuropsychological evaluation is warranted. However, despite the ease of such measures, the relationship between self-report and objective cognitive impairment has been inconsistent, at best. Moreover, factors such as depression, fatigue, anxiety, and personality have been found to be more related to reports of cognitive difficulties. The purpose of the present study was to clarify the relationship between subjective cognitive concerns and objective cognitive impairment while accounting for related symptoms. Methods: We examined the association of self-reported cognitive concerns on the PDQ with objective cognitive measures, as well as depression, anxiety, fatigue, and self-efficacy. Results: There was no relationship between self-reported cognitive concerns and objective performance. Rather, reports on the PDQ were more correlated with reports of depression, anxiety, fatigue, and self-efficacy. Conclusions: Depression and poor self-efficacy can contribute to reports of cognitive difficulties. Effective treatment to improve these factors seems warranted given the impact of perceived cognitive impairment on outcomes in MS and the potential for more accurate self-reports. PMID:27551243

  10. 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

  11. Psychometric Performance and Responsiveness of the Functional Outcomes of Sleep Questionnaire and Sleep Apnea Quality of Life Index in a Randomized Trial: The HomePAP Study

    PubMed Central

    Billings, Martha E.; Rosen, Carol L.; Auckley, Dennis; Benca, Ruth; Foldvary-Schaefer, Nancy; Iber, Conrad; Zee, Phyllis C.; Redline, Susan; Kapur, Vishesh K.

    2014-01-01

    Study Objectives: Measures of health-related quality of life (HRQL) specific for sleep disorders have had limited psychometric evaluation in the context of randomized controlled trials (RCTs). We investigated the psychometric properties of the Functional Outcomes of Sleep Questionnaire (FOSQ) and Sleep Apnea Quality of Life Index (SAQLI). We evaluated the FOSQ and SAQLI construct and criterion validity, determined a minimally important difference, and assessed for associations of responsiveness to baseline subject characteristics and continuous positive airway pressure (CPAP) adherence in a RCT population. Design: Secondary analysis of data collected in a multisite RCT of home versus laboratory-based diagnosis and treatment of obstructive sleep apnea (HomePAP trial). Participants: Individuals enrolled in the HomePAP trial (n = 335). Interventions: N/A. Measurement and Results: The FOSQ and SAQLI subscores demonstrated high reliability and criterion validity, correlating with Medical Outcomes Study 36-Item Short Form Survey domains. Correlations were weaker with the Epworth Sleepiness Scale (ESS). Both the FOSQ and SAQLI scores improved after 3 mo with CPAP therapy. Averaging 4 h or more of CPAP use was associated with an increase in the FOSQ beyond the minimally important difference. Baseline depressive symptoms and sleepiness predicted FOSQ and SAQLI responsiveness; demographic, objective obstructive sleep apnea (OSA) severity and sleep habits were not predictive in linear regression. Conclusions: The Functional Outcomes of Sleep Questionnaire (FOSQ) and Sleep Apnea Quality of Life Index (SAQLI) are responsive to CPAP intervention, with the FOSQ being more sensitive to differences in CPAP adherence than the SAQLI. These instruments provide unique information about health outcomes beyond that provided by changes in physiological measures of OSA severity (apnea-hypopnea index). Clinical Trial Information: Portable Monitoring for Diagnosis and Management of Sleep

  12. 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

  13. A Randomized Controlled Trial of Patient-Reported Outcomes With Tai Chi Exercise in Parkinson's Disease

    PubMed Central

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

    2014-01-01

    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

  14. 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…

  15. The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: reliability and validity of the Swedish version evaluated in 176 patients.

    PubMed

    Atroshi, I; Gummesson, C; Andersson, B; Dahlgren, E; Johansson, A

    2000-12-01

    The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed to measure upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale. We performed cross-cultural adaptation of the DASH to Swedish, using a process that included double forward and backward translations, expert and lay review, as well as field-testing to achieve linguistic and conceptual equivalence. The Swedish version's reliability and validity were then evaluated in 176 patients with upper-extremity conditions. The patients completed the DASH and SF-12 generic health questionnaire before elective surgery or physical therapy. Internal consistency of the DASH was high (Cronbach alpha 0.96). Test-retest reliability, evaluated in a subgroup of 67 patients who completed the DASH on two occasions, with a median interval of 7 days, was excellent (intraclass correlation coefficient 0.92). Construct validity was shown by a positive correlation of DASH scores with the SF-12 scores (worse upper-extremity disability correlating with worse general health), stronger correlation with the SF-12 physical than with the mental health component, correlation of worse DASH scores with worse self-rated global health, and ability to discriminate among conditions known to differ in severity. The Swedish version of the DASH is a reliable and valid instrument that can provide a standardized measure of patient-centered outcomes in upper-extremity musculoskeletal conditions. PMID:11145390

  16. 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.

  17. 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

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

    PubMed

    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

  19. The Application of Structured Job Analysis Information Based on the Position Analysis Questionnaire (PAQ). Final Report No. 9.

    ERIC Educational Resources Information Center

    McCormick, Ernest J.

    The Position Analysis Questionnaire (PAQ) is a job analysis instrument consisting of 187 job elements organized into six divisions. The PAQ was used in the eight studies summarized in this final report. The studies were: (1) ratings of the attribute requirements of PAQ job elements, (2) a series of principal components analyses of these attribute…

  20. 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…

  1. 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…

  2. 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. PMID:27330126

  3. Patient-reported outcome measures after total knee arthroplasty

    PubMed Central

    Ramkumar, P. N.; Harris, J. D.; Noble, P. C.

    2015-01-01

    Objectives A lack of connection between surgeons and patients in evaluating the outcome of total knee arthroplasty (TKA) has led to the search for the ideal patient-reported outcome measure (PROM) to evaluate these procedures. We hypothesised that the desired psychometric properties of the ideal outcome tool have not been uniformly addressed in studies describing TKA PROMS. Methods A systematic review was conducted investigating one or more facets of patient-reported scores for measuring primary TKA outcome. Studies were analysed by study design, subject demographics, surgical technique, and follow-up adequacy, with the ‘gold standard’ of psychometric properties being systematic development, validity, reliability, and responsiveness. Results A total of 38 articles reported outcomes from 47 different PROMS to 85 541 subjects at 26.3 months (standard deviation 30.8) post-operatively. Of the 38, eight developed new scores, 20 evaluated existing scores, and ten were cross-cultural adaptation of existing scores. Only six of 38 surveyed studies acknowledged all ‘gold standard’ psychometric properties. The most commonly studied PROMS were the Oxford Knee Score, New Knee Society Score, Osteoarthritis Outcome Score, and Western Ontario and McMaster Universities Osteoarthritis Index. Conclusions A single, validated, reliable, and responsive PROM addressing TKA patients’ priorities has not yet been identified. Moreover, a clear definition of a successful procedure remains elusive. Cite this article: Bone Joint Res 2015;4:120–127 PMID:26220999

  4. 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…

  5. 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…

  6. Longitudinal Surveys of Australian Youth (LSAY) 2009 Cohort: Wave 3 (2011)--Questionnaire. Technical Report 72A

    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 3 (2011) data set.

  7. 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.

  8. 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…

  9. 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 of…

  10. Transfer Student Questionnaire: Results of 1973 Survey. Special Report 74-5.

    ERIC Educational Resources Information Center

    Holahan, Carole K.; Kelley, H. Paul

    To obtain a demographic description of University of Texas at Austin (U.T. Austin) transfer students, to investigate transfer students' evaluations of the university and of their previous college, and to compare transfer students with non-transfer undergraduate students, 1,365 responses to a questionnaire were analyzed. The survey explored student…

  11. IITS Students' Evaluation Questionnaire for the Fall Semester of 1991. A Summary and Report.

    ERIC Educational Resources Information Center

    Jones, Ted

    A mail survey of students enrolled in distance education classes in library science and health education and promotion was conducted after the courses were first offered in the fall semester of 1991. The 77-item questionnaire explored attitudes, opinions, and preferences relating to the Intercampus, Interactive Telecommunications System (IITS),…

  12. 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

  13. 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.

  14. Reliability and Validity Assessment of Mizaj Questionnaire: A Novel Self-report Scale in Iranian Traditional Medicine

    PubMed Central

    Mojahedi, Morteza; Naseri, Mohsen; Majdzadeh, Reza; Keshavarz, Mansoor; Ebadini, Mohammad; Nazem, Esmaeil; Saberi Isfeedvajani, Mohsen

    2014-01-01

    Background In Iranian Traditional Medicine, mizaj (temperament) plays a key role in preventive, therapeutic and lifestyle recommendations. A reliable self-reported scale for mizaj identification is critically needed to introduce ITM into the official medical and health care system especially in the case of designing national preventive protocols. Objectives The present study aimed to design a preliminary self-administered mizaj questionnaire and assessed its reliability and validity in Iran. Patients and Methods In this cross-sectional study, a questionnaire with 52 items was designed based on mizaj-related indices. Subsequent to content and face validity assessment, using qualitative and quantitative method, 47 items remained. Based on the non-randomly sampling, the test-retest reliability of each question and internal consistency of the questionnaire was examined by the participation of 35 volunteers. The reliable version questionnaire was filled up by 52 volunteers wherein they were divided into warm/cold and wet/dry groups based on their mizaj which was predetermined by a team of expert practitioners. Logistic regression analysis was performed for validity process between the experts’ assessment of mizaj and each of the items in the questionnaire that resulted to the final ten-item questionnaire divided into two subscales. By using ANOVA and post Hoc with Dunnet statistics, the optimum cut-off points were defined and their sensitivity and specificity was assessed. Results The weighted kappa coefficients of the 39 items were between 0.40 and 0.82 showing their acceptable reliability and the Cronbach’s α coefficient was 0.71 showing the internal consistency. The sensitivity and specificity of the final questionnaire cut-off points were 65% and 93% for the warm group, 52% and 97% cold group, 53% and 67% dry group and finally 53% and 76% wet group. Conclusions Our results suggested that many of the designed questions according to the literature’s mizaj

  15. 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

  16. 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

  17. 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.

  18. 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.

  19. The Validity of Questionnaire Self-Report of Psychopathology and Parent-Child Relationship Quality in Juvenile Delinquents with Psychiatric Disorders

    ERIC Educational Resources Information Center

    Breuk, R. E.; Clauser, C. A. C.; Stams, G. J. J. M.; Slot, N. W.; Doreleijers, T. A. H.

    2007-01-01

    The present study focuses on the validity of questionnaire self-report of psychopathology and parent-child relationship quality for juvenile delinquents with severe behavioural and psychiatric disorders by comparing information derived from questionnaire self-report with information from other sources, including parent report, in-depth…

  20. 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.

  1. 'The patient': at the center of patient-reported outcomes.

    PubMed

    Awad, A George

    2015-01-01

    The recent emphasis of including patient reports in their own care management is reviewed in terms of the factors that contributed to its popularity. The role change of patients as being active participants in their own care as a result of the rising consumerism and advocacy has led to increased pressures for including patients in the therapeutic decision-making process. As consumers of clinical services, their perspectives and attitudes towards health and illness acquired more importance. The rising cost of healthcare has added another dimension in cost containment by empowering patients and sharing responsibility in their recovery, which hopefully can improve outcomes. Challenges in the development and implementation of patient-reported outcomes in psychiatry are reviewed and include the still unresolved subjective/objective dichotomy, identification of the most appropriate and relevant patient-reported outcomes. Few outcomes are identified and include: subjective tolerability of medication, self-reported health-related quality of life, preferences, patients' attitudes towards health and illness, satisfaction with medication and overall satisfaction of quality of care, and functional state, with particular focus on social functioning. PMID:26289737

  2. Student Reports of Peer Threats of Violence: Prevalence and Outcomes

    ERIC Educational Resources Information Center

    Nekvasil, Erin K.; Cornell, Dewey G.

    2012-01-01

    Authorities in education and law enforcement have recommended that schools use a threat-assessment approach to prevent violence, but there is relatively little research on characteristics and outcomes of threats among students. The current study examined student reports of threat experiences in a sample of 3,756 high school students. Approximately…

  3. 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

  4. Raising future forensic pathologists (first report): results of a preliminary questionnaire survey.

    PubMed

    Murakami, Manabu; Matoba, Kotaro; Terazawa, Koichi

    2012-08-01

    The shortage of future forensic pathologists is a serious problem both in Japan and overseas. In Japan, however, factors such as government budget cuts and increasing the autopsy rates, make the condition even worse. In an attempt to improve this situation, we implemented a questionnaire survey to investigate the particular features necessary when selecting a career in forensic medicine. As a preliminary study, we sent the questionnaire along with an anonymous answer sheet to all forensic pathologists with a degree in medicine M.D., who were affiliated with universities in Hokkaido and the Tohoku district of Japan as of August 2011. Thirteen physicians in nine universities (response rate 77.8%) returned the answer sheet. Characteristics of participants are listed below: years of experience, board specialty and number of years as board certified specialists, percentage of work effort spent on autopsy practice, the time when they decided to work as a forensic pathologist, the time when to best recommend forensic pathologist as a career, and crucial factors in choosing the specialty of forensic medicine. As a result of this research, we've revealed the importance of undergraduate medical education or the effect on the role models. Furthermore, we've also extracted miscellaneous comments, such as standardization of minimum requirements. In our study, we' ve found some clues to increase future candidates in the field forensic medicine. However, we must collect further samples for our questionnaire survey to validate the study, and, as a future project, we must also address this problem at the congress of forensic medicine. PMID:23016267

  5. 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…

  6. 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

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

    PubMed

    Harmon-Jones, Cindy; Bastian, Brock; Harmon-Jones, Eddie

    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

  8. Predictable Outcomes with Porcelain Laminate Veneers: A Clinical Report.

    PubMed

    Pimentel, Welson; Teixeira, Marcelo Lucchesi; Costa, Priscila Paganini; Jorge, Mônica Zacharias; Tiossi, Rodrigo

    2016-06-01

    This clinical report describes how to achieve predictable outcomes for anterior teeth esthetic restorations with porcelain laminate veneers by associating the digital planning and design of the restoration with interim restorations. The previous digital smile design of the restoration eliminates the communication barrier with the patient and assists the clinician throughout patient treatment. Interim restorations (diagnostic mock-ups) further enhance communication with the patient and prevent unnecessary tooth reduction for conservative tooth preparation. Adequate communication between patient and clinician contributes to successful definitive restorations and patient satisfaction with the final esthetic outcome. PMID:26633080

  9. Predictable Outcomes with Porcelain Laminate Veneers: A Clinical Report.

    PubMed

    Pimentel, Welson; Teixeira, Marcelo Lucchesi; Costa, Priscila Paganini; Jorge, Mônica Zacharias; Tiossi, Rodrigo

    2016-06-01

    This clinical report describes how to achieve predictable outcomes for anterior teeth esthetic restorations with porcelain laminate veneers by associating the digital planning and design of the restoration with interim restorations. The previous digital smile design of the restoration eliminates the communication barrier with the patient and assists the clinician throughout patient treatment. Interim restorations (diagnostic mock-ups) further enhance communication with the patient and prevent unnecessary tooth reduction for conservative tooth preparation. Adequate communication between patient and clinician contributes to successful definitive restorations and patient satisfaction with the final esthetic outcome.

  10. The Zuckerman-Kuhlman personality questionnaire in bipolar I and II disorders: a preliminary report.

    PubMed

    Xu, Shaofang; Gao, Qianqian; Ma, Liji; Fan, Hongying; Mao, Hongjing; Liu, Jian; Wang, Wei

    2015-03-30

    Patients with bipolar disorder have tendencies of higher impulsivity and sensation seeking, they might contribute differently to the emotional states of bipolar I (BD I) and II (BD II). We administered the Zuckerman-Kuhlman Personality Questionnaire (ZKPQ), the Plutchik-van Praag Depression Inventory (PVP), the Mood Disorder Questionnaire (MDQ), and the Hypomania Checklist (HCL-32) in 23 patients with BD I, 22 BD II, and 64 healthy volunteers. Both BD I and II scored higher on ZKPQ Impulsive sensation seeking (and its Impulsivity facet), Neuroticism-anxiety and Aggression-hostility, and on PVP and HCL-32 scales than controls did; BD I scored higher on MDQ and General sensation seeking facet than controls did. Compared to BD II, BD I scored higher on Impulsive sensation seeking (and General sensation seeking) and on MDQ. Moreover, General sensation seeking predicted MDQ, and Activity predicted HCL-32 in BD I. Aggression-hostility predicted HCL-32 in BD II. General sensation seeking predicted MDQ and HCL-32, and together with Neuroticism-anxiety, predicted PVP in controls. Our study suggests that Impulsive sensation seeking, and its General sensation seeking facet might help to delineate the two types of bipolar disorder. PMID:25660665

  11. Functional Performance Testing and Patient Reported Outcomes following ACL Reconstruction: A Systematic Scoping Review.

    PubMed

    Almangoush, Adel; Herrington, Lee

    2014-01-01

    Objective. A systematic scoping review of the literature to identify functional performance tests and patient reported outcomes for patients who undergo anterior cruciate ligament (ACL) reconstruction and rehabilitation that are used in clinical practice and research during the last decade. Methods. A literature search was conducted. Electronic databases used included Medline, PubMed, Cochrane Library, EMBASE, CINAHL, SPORTDiscus, PEDro, and AMED. The inclusion criteria were English language, publication between April 2004 and April 2014, and primary ACL reconstruction with objective and/or subjective outcomes used. Two authors screened the selected papers for title, abstract, and full-text in accordance with predefined inclusion and exclusion criteria. The methodological quality of all papers was assessed by a checklist of the Critical Appraisal Skills Programme (CASP). Results. A total of 16 papers were included with full-text. Different authors used different study designs for functional performance testing which led to different outcomes that could not be compared. All papers used a measurement for quantity of functional performance except one study which used both quantity and quality outcomes. Several functional performance tests and patient reported outcomes were identified in this review. Conclusion. No extensive research has been carried out over the past 10 years to measure the quality of functional performance testing and control stability of patients following ACL reconstruction. However this study found that the measurement of functional performance following ACL reconstruction consisting of a one-leg hop for a set distance or a combination of different hops using limb symmetry index (LSI) was a main outcome parameter of several studies. A more extensive series of tests is suggested to measure both the quantitative and qualitative aspects of functional performance after the ACL reconstruction. The KOOS and the IKDC questionnaires are both measures that

  12. Functional Performance Testing and Patient Reported Outcomes following ACL Reconstruction: A Systematic Scoping Review

    PubMed Central

    Herrington, Lee

    2014-01-01

    Objective. A systematic scoping review of the literature to identify functional performance tests and patient reported outcomes for patients who undergo anterior cruciate ligament (ACL) reconstruction and rehabilitation that are used in clinical practice and research during the last decade. Methods. A literature search was conducted. Electronic databases used included Medline, PubMed, Cochrane Library, EMBASE, CINAHL, SPORTDiscus, PEDro, and AMED. The inclusion criteria were English language, publication between April 2004 and April 2014, and primary ACL reconstruction with objective and/or subjective outcomes used. Two authors screened the selected papers for title, abstract, and full-text in accordance with predefined inclusion and exclusion criteria. The methodological quality of all papers was assessed by a checklist of the Critical Appraisal Skills Programme (CASP). Results. A total of 16 papers were included with full-text. Different authors used different study designs for functional performance testing which led to different outcomes that could not be compared. All papers used a measurement for quantity of functional performance except one study which used both quantity and quality outcomes. Several functional performance tests and patient reported outcomes were identified in this review. Conclusion. No extensive research has been carried out over the past 10 years to measure the quality of functional performance testing and control stability of patients following ACL reconstruction. However this study found that the measurement of functional performance following ACL reconstruction consisting of a one-leg hop for a set distance or a combination of different hops using limb symmetry index (LSI) was a main outcome parameter of several studies. A more extensive series of tests is suggested to measure both the quantitative and qualitative aspects of functional performance after the ACL reconstruction. The KOOS and the IKDC questionnaires are both measures that

  13. Korean atomic bomb survivors' report on the present status and health of their children: a mail questionnaire survey.

    PubMed

    Jhun, Hyung-Joon; Ju, Young-Su; Kim, Jung-Bum; Kim, Jin-Kook

    2006-01-01

    A mail questionnaire survey on the present status and health of children of Korean survivors of the 1945 atomic bombing of Japan was conducted in 2004. In total, 1,115 Korean A-bomb survivors' reports on demographic factors and the health of their children (n = 4,079) were analysed. In 2004, 293 of their children were reported to have died and 3,786 children still living. Among the deceased children, the cause of death was unidentified in 64 per cent of cases. The most frequently reported cause of death was infectious disease (9.6%). Most of the deaths (51%) were reported to have occurred in children less than ten years old. The most frequently reported congenital disorders among living children were mental retardation (0.18%) and congenital bone disorders (0.18%). Further study and administrative support are needed to more accurately determine the status of Korean A-bomb survivors and their children.

  14. Patient-reported outcomes as primary end points in clinical trials of inflammatory bowel disease.

    PubMed

    Williet, Nicolas; Sandborn, William J; Peyrin-Biroulet, Laurent

    2014-08-01

    The Food and Drug Administration (FDA) is moving from the Crohn's Disease Activity Index to patient-reported outcomes (PROs) and objective measures of disease, such as findings from endoscopy. PROs will become an important aspect of assessing activity of inflammatory bowel disease (IBD) and for labeling specific drugs for this disease. PROs always have been considered in the management of patients with rheumatoid arthritis or multiple sclerosis, and have included measurements of quality of life, disability, or fatigue. Several disease-specific scales have been developed to assess these PROs and commonly are used in clinical trials. Outcomes reported by patients in clinical trials of IBD initially focused on quality of life, measured by the Short-Form 36 questionnaire or disease-specific scales such as the Inflammatory Bowel Disease Questionnaire or its shorter version. Recently considered factors include fatigue, depression and anxiety, and work productivity, as measured by the Functional Assessment Chronic Illness Therapy-Fatigue, the Hospital Anxiety Depression, and the Work Productivity Activity Impairment Questionnaire, respectively. However, few data are available on how treatment affects these factors in patients with IBD. Although disability generally is recognized in patients with IBD, it is not measured. The international IBD disability index currently is being validated. None of the PROs currently used in IBD were developed according to FDA guidance for PRO development. PROs will be a major primary end point of future trials. FDA guidance is needed to develop additional PROs for IBD that can be incorporated into trials, to better compare patients' experience with different therapies. PMID:24534550

  15. 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.

  16. 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

  17. 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

  18. Questionnaire-based self-reported nutrition habits associate with serum metabolism as revealed by quantitative targeted metabolomics.

    PubMed

    Altmaier, Elisabeth; Kastenmüller, Gabi; Römisch-Margl, Werner; Thorand, Barbara; Weinberger, Klaus M; Illig, Thomas; Adamski, Jerzy; Döring, Angela; Suhre, Karsten

    2011-02-01

    Nutrition plays an important role in human metabolism and health. However, it is unclear in how far self-reported nutrition intake reflects de facto differences in body metabolite composition. To investigate this question on an epidemiological scale we conducted a metabolomics study analyzing the association of self-reported nutrition habits with 363 metabolites quantified in blood serum of 284 male participants of the KORA population study, aged between 55 and 79 years. Using data from an 18-item food frequency questionnaire, the consumption of 18 different food groups as well as four derived nutrition indices summarizing these food groups by their nutrient content were analyzed for association with the measured metabolites. The self-reported nutrition intake index "polyunsaturated fatty acids" associates with a decrease in saturation of the fatty acid chains of glycero-phosphatidylcholines analyzed in serum samples. Using a principal component analysis dietary patterns highly associating with serum metabolite concentrations could be identified. The first principal component, which was interpreted as a healthy nutrition lifestyle, associates with a decrease in the degree of saturation of the fatty acid moieties of different glycero-phosphatidylcholines. In summary, this analysis shows that on a population level metabolomics provides the possibility to link self-reported nutrition habits to changes in human metabolic profiles and that the associating metabolites reflect the self-reported nutritional intake. Moreover, we could show that the strength of association increases when composed nutrition indices are used. Metabolomics may, thus, facilitate evaluating questionnaires and improving future questionnaire-based epidemiological studies on human health.

  19. Self-reported non-adherence to ART and virological outcome in a multiclinic UK study.

    PubMed

    Sherr, L; Lampe, F C; Clucas, C; Johnson, M; Fisher, M; Leake Date, H; Anderson, J; Edwards, S; Smith, C J; Hill, T; Harding, R

    2010-08-01

    Adherence is of fundamental importance to ART success. We examined the association of self-reported non-adherence with demographic factors, health and behaviour issues, and virological outcome, in a multi-clinic study. Seven hundred and seventy-eight HIV patients in five clinics in London and Brighton completed a questionnaire on adherence and HIV/health issues at baseline in 2005/6. For 486 subjects taking ART, non-adherence in the past week was defined as: (A)>or=1 dose missed or taken incorrectly (wrong time/circumstances); (B)>or=1 dose missed; (C)>or=2 doses missed. Questionnaire data were matched with routine treatment and virology data for consenting subjects (61.4%). We assessed four virological outcomes in 307 of 486 patients: (i) VL>50c/mL using latest VL at the questionnaire and excluding patients starting HAART<24 weeks ago; (ii) VL>50c/mL using the first VL from 6 to 12 months post-questionnaire; (iii) any VL>50c/mL from 6 to 12 months post-questionnaire; (iv) among patients with VL<50c/mL at questionnaire, time to first subsequent VL>50c/mL over two years follow up. Non-adherence was reported by 278 (57.2%), 102 (21.0%) and 49 (10.1%) of 486 patients, for definitions A, B and C, respectively. Non-adherence declined markedly with older age, and tended to be more commonly reported by Black patients, those born outside the UK, those with greater psychological symptoms and those with suicidal thoughts. There was a weaker association with physical symptoms and no association with gender/sexuality, education, unemployment, or risk behaviour (p>0.1). In logistic regression analyses, younger age, non-UK birth and psychological variables were independent predictors of non-adherence [e.g., for non-adherence B: odds ratios (95% CI) were 0.95 (0.92, 0.98) for every year older age; 1.6 (1.0, 2.5) for non-UK born; 2.3 (1.5, 3.7) for suicidal thoughts]. Non-adherence was associated with poorer virological outcome; the most consistent association was for definition C

  20. The measurement of patient-reported outcomes of refractive surgery: the refractive status and vision profile.

    PubMed Central

    Schein, O D

    2000-01-01

    PURPOSE: To develop a questionnaire, the Refractive Status and Vision Profile (RSVP), to assess health-related quality of life associated with refractive error and its correction. METHODS: The published literature on patient report of visual and overall function was reviewed, and the RSVP was self-administered by 550 participants with refractive error. Cross-sectional validation was performed using standard psychometric techniques. The responsiveness of the RSVP to surgical intervention was assessed prospectively in a subset of 176 patients. The principal outcomes measures were scores on the overall RSVP scale (S) and on 8 RSVP subscales (functioning, driving, concern, expectations, symptoms, glare, optical problems, problems with corrective lenses). RESULTS: The RSVP (S) and its subscales demonstrated very good internal consistency (Cronbach's alpha, 0.70-0.93). S and several subscale scores were independently associated with satisfaction with vision and were more correlated with satisfaction with vision than with either visual acuity or refractive error. Higher refractive error was associated with lower scores on S and on 5 subscales. In the prospective surgical cohort, 15% of patients had some worsening in their total RSVP score; however, substantial variation was seen in the individual subscales where worsening ranged from 7% (problems with corrective lenses) to 41% (driving). The effect size (measure of responsiveness) of the RSVP and most of its subscales was very high. Approximately 14% of patients had significant worsening in 3 or more subscales, and this outcome was found to be independently associated with being dissatisfied with vision following surgery (OR, 5.84; 95% CI, 1.88, 8.13). CONCLUSIONS: The RSVP has been validated as a questionnaire that measures patient-reported quality of life related to refractive error and its correction. It is responsive to surgical intervention and provides important information regarding patient outcomes not available

  1. 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

  2. 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.

  3. 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

  4. Patient-Reported Outcome Coordinator Did Not Improve Quality of Life Assessment Response Rates: A Report from the Children's Oncology Group

    PubMed Central

    Johnston, Donna; Gerbing, Robert; Alonzo, Todd; Aplenc, Richard; Nagarajan, Rajaram; Schulte, Fiona; Cullen, Patricia; Sung, Lillian

    2015-01-01

    Purpose Health related quality of life (HRQL) assessments during therapy for pediatric cancer provide valuable information to better understand the patient experience. Our objective was to determine the impact of a patient-reported outcome (PRO) coordinator on HRQL questionnaire completion rates during a pediatric acute myeloid leukemia (AML) trial. Methods AAML1031 is a multicenter Children’s Oncology Group therapeutic trial for de novo AML with a secondary aim to assess HRQL of children and adolescents treated with chemotherapy and hematopoietic stem cell transplantation (HSCT). Parents/guardians are the primary respondents and four questionnaires are administered at eight time points. The questionnaires are the PedsQL 4.0 Generic Core Scales, PedsQL 3.0 Acute Cancer Module, PedsQL Multidimensional Fatigue Scale, and the Pediatric Inventory for Parents. To improve response rates, a central PRO coordinator was instituted and reminded sites about upcoming and delinquent questionnaires. The proportion of HRQL questionnaires completed were compared prior to, and following institution of the PRO coordinator. This analysis evaluated the first five assessment time points. Results There were231 families who consented to participate in the HRQL aim. Overall response rates for all questionnaires were 73–83%. At time point 1, within 14 days of chemotherapy initiation, post-PRO coordinator completion rates were significantly higher for three of four questionnaires. However, the effect was not sustained and at time point 4, one month following last chemotherapy or HSCT, completion rates were significantly lower post-PRO coordinator for all four questionnaires. Conclusion Addition of a central PRO coordinator did not result in sustained improvement in HRQL questionnaire completion rates. Efforts to improve response rates must consider other strategies. PMID:25915772

  5. Variation in outcomes in trials reporting effects of diet and lifestyle based intervention on pregnancy outcomes: a systematic review.

    PubMed

    Rogozinska, E; Fen, Y; Molyneaux, E; Khan, K S; Thangaratinam, S

    2014-07-01

    Obesity is a growing threat to women of childbearing age. Increased maternal weight or excessive weight gain in pregnancy is associated with adverse pregnancy outcomes. Interventions based on diet and physical activity minimise gestational weight gain with varied effect on a number of clinical outcomes. There is no consensus amongst the trialists on the core outcomes that need to be reported to inform the clinical care of pregnant women. The aim of this systematic review is to evaluate variation in the type and quality of outcomes reported in systematic reviews and randomised controlled trials on diet and lifestyle interventions on maternal and fetal outcomes. We will assess the correlation between the type of outcome, the quality of the studies and journal impact factor. We searched the major databases from the inception to October 2013 without language restrictions. We used current recommendations for quality of outcome reporting using a 6-point scale. The quality assessment of systematic reviews and RCTs was performed using the AMSTAR and Jadad scoring systems. Additionally we obtained journals' impact factor in the year of publication. We calculated Spearman rank coefficient to assess the correlation between the type of outcome, and study quality. An overview of outcome reporting will show the current attitude of the researchers towards outcomes of importance when conducting trials on diet and lifestyle management in pregnancy. If our abstract is accepted, we will provide the details of the results.

  6. 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…

  7. 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

  8. 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.

  9. 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. PMID:27331907

  10. Development of the PMPQ: A Structural Job Analysis Questionnaire for the Study of Professional and Managerial Positions. PMPQ Report No. 1.

    ERIC Educational Resources Information Center

    Mitchell, Jimmy L.; McCormick, Ernest J.

    The development and analysis of the Professional and Managerial Position Questionnaire (PMPQ) is reported. PMPQ is intended to serve as a job analysis instrument for higher level occupations than those assessed by the Position Analysis Questionnaire (PAQ). Four approaches to job analysis are described with different emphases on the requirements of…

  11. 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

  12. Patient-reported outcome measures in inflammatory bowel disease

    PubMed Central

    El-Matary, Wael

    2014-01-01

    Patient-reported outcome measures (PROMs) are increasingly used in both research and clinical health settings. With the recent development of United States Food and Drug Administration guidance on PROMs, more attention is being devoted to their role and importance in health care. Several methodological challenges in the development, validation and implementation of PROMs must be resolved to ensure their appropriate utilization and interpretation. The present review discusses recent developments and updates in PROMs, with specific focus on the area of inflammatory bowel disease. PMID:25390615

  13. The relationship between pain severity and patient-reported outcomes among patients with chronic low back pain in Japan

    PubMed Central

    Montgomery, William; Vietri, Jeffrey; Shi, Jing; Ogawa, Kei; Kariyasu, Sawako; Alev, Levent; Nakamura, Masaya

    2016-01-01

    Objective The aim of this study was to quantify the impact of pain severity on patient-reported outcomes among individuals diagnosed with chronic low back pain in Japan. Methods Data were provided by the 2012 Japan National Health and Wellness Survey (N=29,997), a web-based survey of individuals in Japan aged ≥18 years. This analysis included respondents diagnosed with low back pain of ≥3-month duration. Measures included the revised Medical Outcomes Study 36-Item Short-Form Survey Instrument, the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7 scale, the Work Productivity and Activity Impairment: General Health questionnaire, and self-reported all-cause health care visits (6 months). Generalized linear models were used to assess the relationship between outcomes and severity of pain in the past week as reported on a numeric rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine), controlling for length of diagnosis, sociodemographics, and general health characteristics. Results A total of 290 respondents were included in the analysis; mean age was 56 years, 41% were females, and 56% were employed. Pain severity was 3/10 for the first quartile, 5/10 for the median, and 7/10 for the third quartile of this sample. Increasing severity was associated with lower scores for mental and physical component summaries and Short-Form 6D health utility, higher depression (Patient Health Questionnaire-9) and anxiety (Generalized Anxiety Disorder-7) scores, greater absenteeism and presenteeism, greater activity impairment, and more health care provider visits (all P<0.0001). Conclusion The impact of chronic low back pain on health-related quality of life, depression and anxiety symptoms, impairment to work and daily activities, and health care use increases with the severity of pain. Interventions reducing the severity of pain may improve numerous health outcomes even if the pain cannot be eliminated. PMID:27330326

  14. 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

  15. 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

  16. Core Outcomes and Common Data Elements in Chronic Subdural Hematoma: A Systematic Review of the Literature Focusing on Reported Outcomes.

    PubMed

    Chari, Aswin; Hocking, Katie C; Broughton, Ellie; Turner, Carole; Santarius, Thomas; Hutchinson, Peter J; Kolias, Angelos G

    2016-07-01

    The plethora of studies in chronic subdural hematoma (CSDH) has not resulted in the development of an evidence-based treatment strategy, largely due to heterogeneous outcome measures that preclude cross-study comparisons and guideline development. This study aimed to identify and quantify the heterogeneity of outcome measures reported in the CSDH literature and to build a case for the development of a consensus-based core outcome set. This systematic review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and was registered with the PROSPERO international prospective register of systematic reviews (CRD42014007266). All full-text English language studies with >10 patients (prospective) or >100 patients (retrospective) published after 1990 examining clinical outcomes in CSDH were eligible for inclusion. One hundred two eligible studies were found. There were 14 (13.7%) randomized controlled trials, one single arm trial (1.0%), 25 (24.5%) cohort comparison studies, and 62 (60.8%) prospective or retrospective cohort studies. Outcome domains reported by the studies included mortality (63.8% of included studies), recurrence (94.1%), complications (48.0%), functional outcomes (40.2%), and radiological (38.2%) outcomes. There was significant heterogeneity in the definitions of the outcome measures, as evidenced by the seven different definitions of the term "recurrence," with no definition given in 19 studies. The time-points of assessment for all the outcome domains varied greatly from inpatient/hospital discharge to 18 months. This study establishes and quantifies the heterogeneity of outcome measure reporting in CSDH and builds the case for the development of a robust consensus-based core outcome set for future studies to adhere to as part of the Core Outcomes and Common Data Elements in CSDH (CODE-CSDH) project.

  17. 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. PMID:26088060

  18. 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.

  19. Differences in medical students' attitudes to academic misconduct and reported behaviour across the years—a questionnaire study

    PubMed Central

    Rennie, S; Rudland, J

    2003-01-01

    Objectives: This study aimed to determine attitudinal and self reported behavioural variations between medical students in different years to scenarios involving academic misconduct. Design: A cross-sectional study where students were given an anonymous questionnaire that asked about their attitudes to 14 scenarios describing a fictitious student engaging in acts of academic misconduct and asked them to report their own potential behaviour. Setting: Dundee Medical School. Participants: Undergraduate medical students from all five years of the course. Method: Questionnaire survey. Main measurements: Differences in medical students' attitudes to the 14 scenarios and their reported potential behaviour with regards to the scenarios in each of the years. Results: For most of the scenarios there was no significant difference in the response between the years. Significant differences in the responses were found for some of the scenarios across the years, where a larger proportion of year one students regarded the scenario as wrong and would not engage in the behaviour, compared to other years. These scenarios included forging signatures, resubmitting work already completed for another part of the course, and falsifying patient information. Conclusion: Observed differences between the years for some scenarios may reflect a change in students' attitudes and behaviour as they progress though the course. The results may be influenced by the educational experience of the students, both in terms of the learning environment and assessment methods used. These differences may draw attention to the potential but unintentional pressures placed on medical students to engage in academic misconduct. The importance of developing strategies to engender appropriate attitudes and behaviours at the undergraduate level must be recognised. PMID:12672890

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

    PubMed

    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

  1. 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

  2. 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

  3. 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

  4. A Test of the Forced-Alternative Random Response Questionnaire Technique. Technical Report No. 75-9.

    ERIC Educational Resources Information Center

    Reaser, Joel M.; And Others

    This study tested a variation of the random response surveying strategy designed for lengthy questionnaires to be used in group administrations or mail surveys. A questionnaire was mailed to a random sample of 3,000 company grade officers divided into three groups. One group received a conventional questionnaire. The second group received a random…

  5. 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

  6. 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

  7. Teacher Questionnaire.

    ERIC Educational Resources Information Center

    Purdue Univ., Lafayette, IN. Educational Research Center.

    The Teacher Questionnaire was designed to provide demographic information about the teacher, information on the school organizational climate, information about instructional and classroom management practices, and a measure of the teacher's verbal facility. Section 1 contains 23 items identifying specific teacher traits and characteristics (sex,…

  8. Musculoskeletal symptoms amongst clinical radiologists and the implications of reporting environment ergonomics--a multicentre questionnaire study.

    PubMed

    Rodrigues, Jonathan C L; Morgan, Steven; Augustine, Katharine; Clague, Gavin; Pearce, Tim; Pollentine, Adrian; Wallis, Adam; Wilson, David; McCoubrie, Paul

    2014-04-01

    This multicentre study aimed to assess compliance of the reporting environment with best ergonomic practice and to determine the prevalence of musculoskeletal symptoms related to working as a radiologist. All 148 radiology trainees and consultants in 10 hospitals across the region were invited to complete a musculoskeletal symptoms and reporting ergonomics questionnaire. Best ergonomic reporting practice was defined, following literature review, as being able to alter the following: monitor, desk, chair and armrest height, chair back support, ambient light, and temperature. The frequency that these facilities were available and how often they were used was determined. One hundred and twenty-three out of 148 (83%) radiologists responded, and 38% reported radiology-associated occupational injury. Lower back discomfort was the commonest radiology associated musculoskeletal symptom (41%). Only 13% of those with occupational injury sought the advice of occupational health. No reporting environments conformed completely to best ergonomic practice. Where certain facilities were available, less than a third of radiologists made personal ergonomic adjustments prior to starting a reporting session. Radiologists who had good self-assessed knowledge of best ergonomic practice had significantly less back discomfort than those with poor self-assessed knowledge (P < 0.005). We demonstrated high prevalence of musculoskeletal symptoms amongst radiologists. Poor compliance of the reporting environment with best ergonomic practice, in combination with our other findings of a low level of ergonomic awareness, low rates of making ergonomic adjustments and seeking appropriate help, may be implicated. We hope this study raises awareness of this issue and helps prevent long-term occupational injury amongst radiologists from poor ergonomic practice. PMID:24113846

  9. 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

  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. 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.

  12. Outcomes following plyometric rehabilitation for the young throwing athlete: a case report.

    PubMed

    Peters, Courtney; George, Steven Z

    2007-01-01

    The current literature offers limited evidence supporting sport-specific plyometric rehabilitation for young throwing athletes. The purposes of this case report were to 1) describe the focused differential diagnosis of a young throwing athlete with shoulder pain and 2) use previously validated, region-specific, health-related quality of life measures to describe clinical outcomes for a rehabilitation program that included sport-specific, plyometric training. The 13-year-old male patient presented in this case report experienced a sudden onset of right shoulder pain while pitching in a baseball game. On physical examination, this patient demonstrated shoulder pain, pain with palpation of the infraspinatus and teres minor muscles, decreased strength of the infraspinatus and teres minor with resultant impaired rotator cuff performance, and signs consistent with anterior shoulder instability. Early rehabilitation consisted of modalities for pain relief and therapeutic exercises to improve strength. In the return to sport phase of rehabilitation, the patient performed sport-specific plyometric exercises that were progressed in difficulty based on the patient's report of pain and muscle soreness. Health-related quality of life was assessed by using the Shoulder Pain and Disability Index (SPADI) and the sports module of the Disability of Arm, Shoulder and Hand (DASH) questionnaires. A standard error of measurement (SEM)-based criterion was used to determine if the patient demonstrated meaningful changes in outcome measures. The patient did not demonstrate meaningful improvement in pain or general disability with the SPADI. The patient did demonstrate a meaningful improvement in sport-specific function with the DASH. It is possible that sport-specific plyometric rehabilitation may have provided additional benefit for this athlete's ability to return to sport, but definite conclusions regarding treatment effectiveness are limited by the case report design. Properly designed

  13. HUMAN HEALTH OUTCOMES AND ACCOUNTABILITY - RISK POLICY REPORT

    EPA Science Inventory

    EPA is identifying human health "outcomes" as part of a significant shift in how the Agency frames questions and assesses its impact on environmental quality. These outcomes, while complementing traditional process indicators such as decreases in emissions, discharges and pollut...

  14. Patient-reported outcomes for US oncology labeling: review and discussion of score interpretation and analysis methods.

    PubMed

    Shields, Alan; Coon, Cheryl; Hao, Yanni; Krohe, Meaghan; Yaworsky, Andrew; Mazar, Iyar; Foley, Catherine; Globe, Denise

    2015-01-01

    This paper describes ways to approach the conceptual and practical challenges associated with interpreting the clinical meaning of scores produced by patient reported outcome (PRO) questionnaires, particularly when used to inform efficacy decisions for regulatory approval for oncology products. Score interpretation estimates are not inherent to PRO questionnaires per se, instead, vary dependent upon sample and study design characteristics. Scores from PRO measures can be interpreted at the individual and group level, and each carries its own set of statistics for evaluating differences. Oncology researchers have a variety of methods and data analytic strategies available to support their score interpretation needs, which should be considered in the context of their a priori knowledge of the target patient population, the hypothesized effects of treatment, the study design and assessment schedule, and the inferences and decisions to be made from the PRO data. PMID:26594897

  15. 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.

  16. 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

  17. Patient-reported outcomes of brentuximab vedotin in Hodgkin lymphoma and anaplastic large-cell lymphoma

    PubMed Central

    Chen, Robert; Allibone, Suzanne; Bartlett, Nancy L; Brice, Pauline; Chen, Andy; Pose, Katrina; Rich, Lynn; Bonthapally, Vijay; Garfin, Phillip M; Fanale, Michelle

    2016-01-01

    Background Patients with relapsed/refractory (R/R) Hodgkin lymphoma (HL) or R/R systemic anaplastic large-cell lymphoma (sALCL) treated with brentuximab vedotin (BV) experienced high remission rates in two Phase II trials. With increased response rates and survival times, patient-reported outcomes (PROs) and health-related quality of life (HRQoL) are becoming increasingly important and can help inform treatment decisions to enhance care of cancer patients. Objective The objective was to qualitatively assess HRQoL in long-term survivors treated with BV. Methods An eight-question survey assessing PRO-related aspects was developed and fielded to a subset of patients with HL or sALCL who remained in long-term follow-up after completing BV treatment in the two pivotal studies. Results The survey was completed by 25 of 38 patients (12 with HL, 13 with sALCL). The majority of patients reported that their energy level, outlook on life, difficulties with daily activities, ability to participate in physical activities, and overall HRQoL improved compared to those before BV treatment. Limitations Small sample size and lack of a baseline questionnaire or validated assessment instrument limit broad applicability of these findings to large populations of patients with HL or sALCL. Conclusion This is the first report of BV PRO data in R/R HL and sALCL. Given the patients’ poor prognostic outcomes before stem cell transplant, these encouraging results warrant formal evaluation of PRO end points in BV trials. PMID:27103829

  18. Parent Reports of Mental Health Concerns and Functional Impairment on Routine Screening with the Strengths and Difficulties Questionnaire

    PubMed Central

    Biel, Matthew G.; Kahn, Nicole F.; Srivastava, Anjuli; Mete, Mihriye; Banh, My K.; Wissow, Lawrence S.; Anthony, Bruno J.

    2015-01-01

    Objective This study used the Strengths and Difficulties Questionnaire (SDQ) to describe the prevalence of parent-reported mental health (MH) concerns in youth presenting for primary care appointments and to examine relationships between children’s MH issues and functional impairment. We hypothesized that increased MH symptomology would be associated with increased impairment and family burden. Methods Parents of 4–17 years old children were approached at routine visits in 13 primary care sites. Chi-square tests, independent samples t-tests, and a one-way analysis of variance (ANOVA) were used to make comparisons between demographic groups. Age-, sex-, and race-adjusted ordered logistic regression models and ANOVAs examined relationships between impact and SDQ scales. Results Boys had higher total Hyperactivity and Peer Problems. Adolescents showed higher Emotional Symptoms, while younger children showed more Hyperactivity. Latinos reported more Conduct Problems, Hyperactivity, and Peer Problems. Latinos also indicated less distress on the child, impairment at home and school, and family burden. Regression analyses indicated increased odds of impairment with higher scale scores. MH symptoms identified with the SDQ in pediatric primary care settings were associated with parent-reported impairment affecting youth and their families. Conclusions The presence of significant impairment suggests that parents’ concerns identified by screening are likely to be clinically important and worthy of practice strategies designed to promote assessment, treatment, and referral for these common problems. Identifying and exploring parents’ concerns with strategic use of screening tools may allow PCPs to directly engage families around the MH issues that affect them most. PMID:25922333

  19. 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 ...

  20. Physiotherapists use of and perspectives on the importance of patient-reported outcome measures for shoulder dysfunction

    PubMed Central

    Michener, Lori A

    2014-01-01

    Background Many patient-reported outcome measures (PROs) for shoulder dysfunctions have acceptable psychometric properties. The present study examined current PRO usage and perceived importance. Methods Delegates at the 2010 International Congress of Shoulder and Elbow Therapists were invited to participate in this cross-sectional observational study. Research Electronic Data Capture (REDCap) web-based tools were used to design an online questionnaire, which was e-mailed to participants. Results Participants (n = 101) reflected an 84% response rate. PRO use was considered ‘extremely’ or ‘very’ important by the majority of clinicians (76%) and researchers (98%). Most commonly used as a primary outcome by clinicians and researchers, respectively, were the Disabilities of the Arm Shoulder Hand Questionnaire (DASH) (40%, 44%) and the Oxford Shoulder Scale (OSS) (36%, 22%) and, as secondary outcomes, the DASH (33%, 28%), OSS (17%, 8%), the Shoulder Pain and Disability Index (SPADI) (8%,18%), and American Shoulder and Elbow Surgeons standardized assessment form (ASES) (8%, 13%). Psychometric properties were rated as ‘extremely’ or ‘very’ important by 86% to 96% of participants. Conclusions The majority of shoulder therapists consider PRO use to be very important and psychometric properties to be critical in PRO selection. The DASH, OSS, SPADI and ASES are most commonly used in clinical practice and research studies. PMID:27582938

  1. Tinnitus Outcomes Assessment

    PubMed Central

    Meikle, Mary B.; Stewart, Barbara J.; Griest, Susan E.; Henry, James A.

    2008-01-01

    Over the past two decades, recognition has grown that measures for evaluating treatment outcomes must be designed specifically to have high responsiveness. With that in mind, four major types of tinnitus measures are reviewed, including psychoacoustic measures, self-report questionnaires concerning functional effects of tinnitus, various rating scales, and global outcome measures. Nine commonly used tinnitus questionnaires, developed in the period 1980–1980, are reviewed. Because of many similarities between tinnitus and pain, comparisons between pain and tinnitus measures are discussed, and recommendations that have been made for developing a core set of measures to evaluate treatment-related changes in pain are presented as providing a fruitful path for developing a core set of measures for tinnitus. Finally, the importance of having both immediately obtainable outcome measures (psychoacoustic, rating scales, or single global measures) and longer term measures (questionnaires covering the negative effects of tinnitus) is emphasized for further work in tinnitus outcomes assessment. PMID:18599500

  2. Tinnitus outcomes assessment.

    PubMed

    Meikle, Mary B; Stewart, Barbara J; Griest, Susan E; Henry, James A

    2008-09-01

    Over the past two decades, recognition has grown that measures for evaluating treatment outcomes must be designed specifically to have high responsiveness. With that in mind, four major types of tinnitus measures are reviewed, including psychoacoustic measures, self-report questionnaires concerning functional effects of tinnitus, various rating scales, and global outcome measures. Nine commonly used tinnitus questionnaires, developed in the period 1980-2000, are reviewed. Because of many similarities between tinnitus and pain, comparisons between pain and tinnitus measures are discussed, and recommendations that have been made for developing a core set of measures to evaluate treatment-related changes in pain are presented as providing a fruitful path for developing a core set of measures for tinnitus. Finally, the importance of having both immediately obtainable outcome measures (psychoacoustic, rating scales, or single global measures) and longer term measures (questionnaires covering the negative effects of tinnitus) is emphasized for further work in tinnitus outcomes assessment. PMID:18599500

  3. Patient-reported outcomes of parenteral somatostatin analogue injections in 195 patients with acromegaly

    PubMed Central

    Strasburger, Christian J; Karavitaki, Niki; Störmann, Sylvère; Trainer, Peter J; Kreitschmann-Andermahr, Ilonka; Droste, Michael; Korbonits, Márta; Feldmann, Berit; Zopf, Kathrin; Sanderson, Violet Fazal; Schwicker, David; Gelbaum, Dana; Haviv, Asi; Bidlingmaier, Martin; Biermasz, Nienke R

    2016-01-01

    Background Long-acting somatostatin analogues delivered parenterally are the most widely used medical treatment in acromegaly. This patient-reported outcomes survey was designed to assess the impact of chronic injections on subjects with acromegaly. Methods The survey was conducted in nine pituitary centres in Germany, UK and The Netherlands. The questionnaire was developed by endocrinologists and covered aspects of acromegaly symptoms, injection-related manifestations, emotional and daily life impact, treatment satisfaction and unmet medical needs. Results In total, 195 patients participated, of which 112 (57%) were on octreotide (Sandostatin LAR) and 83 (43%) on lanreotide (Somatuline Depot). The majority (>70%) of patients reported acromegaly symptoms despite treatment. A total of 52% of patients reported that their symptoms worsen towards the end of the dosing interval. Administration site pain lasting up to a week following injection was the most frequently reported injection-related symptom (70% of patients). Other injection site reactions included nodules (38%), swelling (28%), bruising (16%), scar tissue (8%) and inflammation (7%). Injection burden was similar between octreotide and lanreotide. Only a minority of patients received injections at home (17%) and 5% were self-injecting. Over a third of patients indicated a feeling of loss of independence due to the injections, and 16% reported repeated work loss days. Despite the physical, emotional and daily life impact of injections, patients were satisfied with their treatment, yet reported that modifications that would offer major improvement over current care would be ‘avoiding injections’ and ‘better symptom control’. Conclusion Lifelong injections of long-acting somatostatin analogues have significant burden on the functioning, well-being and daily lives of patients with acromegaly. PMID:26744896

  4. Self-report outcome in new hearing-aid users: Longitudinal trends and relationships between subjective measures of benefit and satisfaction

    PubMed Central

    Vestergaard, Martin D.

    2008-01-01

    This study focussed on self-report outcome in new hearing-aid users. The objectives of the experiment were changes in self-report outcome over time, and relationships between different subjective measures of benefit and satisfaction. Four outcome inventories and a questionnaire on auditory lifestyle were administered to 25 hearing-aid users repeatedly after hearing-aid fitting, and assessments took place one week, four weeks, and 13 weeks after hearing-aid provision. The results showed that, for first-time users who used their hearing aids more than four hours per day, self-reported outcome increased over 13 weeks in some scales, although there was no change in amplification during this time. Furthermore, it was found that, for data collected immediately post-fitting, some subscales were much less face valid than for data collected later. This result indicates that the way in which hearing-aid users assess outcome changes over time. The practical consequence of the results is that early self-report outcome assessment may be misleading for some self-report outcome schemes. PMID:16938796

  5. 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

  6. 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

  7. Measuring patient-reported outcomes in advanced gastric cancer

    PubMed Central

    Xu, Jianming; Evans, TR Jeffry; Coon, Cheryl; Copley-Merriman, Kati; Su, Yun

    2013-01-01

    Background Gastric cancer (GC), one of the most common cancers in the world, is often diagnosed at an advanced stage and associated with a poor prognosis. Quality of life and patient-reported outcomes (PROs) are important considerations when treating GC patients. The aim of this study was to identify existing PRO instruments that would be appropriate for use in GC trials. Methods Data were obtained from a systematic literature review and interviews with clinical experts. A literature search was conducted using OVID (EMBASE and MEDLINE) and yielded 1,008 abstracts; 92 assessed PROs in an advanced GC. Results Key symptoms and functional impacts identified through the literature and expert input included abdominal pain or pain at the site of distant metastases, dysphagia and other symptoms related to eating, and digestive symptoms. The liver and lungs were the most frequent locations of metastases, leading to dyspnea, abdominal fullness, and jaundice. Symptoms related to changes in bowel habits appeared to be more frequent and pronounced in Asian patients, possibly due to the higher prevalence of GC in the body of the stomach in this population. The five most commonly used PRO instruments were identified, but their validity in advanced-stage GC patients remains unclear. Conclusions The symptoms and functional impacts identified here should be confirmed with robust input from advanced-stage GC patients. Optimal measurement of PROs in GC should account for patient burden and possible differences between Asian and non-Asian patients. PMID:24062809

  8. 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.

  9. 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…

  10. 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...

  11. Swedish Version of Mood Spectrum Self-Report Questionnaire: Psychometric Properties of Lifetime and Last-week Version

    PubMed Central

    Ioannou, Michael; Dellepiane, Marzia; Benvenuti, Antonella; Feloukatzis, Konstantinos; Skondra, Nektaria; Dell'Osso, Liliana; Steingrímsson, Steinn

    2016-01-01

    Background: Mood Spectrum Self Report (MOODS-SR) is an instrument that assesses mood spectrum symptomatology including subthreshold manifestations and temperamental features. There are different versions of the MOODS-SR for different time frames of symptom assessment: lifetime (MOODS-LT), last-month and last-week (MOODS-LW) versions. Objective: To evaluate the psychometric properties of the MOODS-LT the MOODS-LW. Methods: The reliability of the MOODS-LT and MOODS-LW was evaluated in terms of internal consistency and partial correlations among domains and subdomains. The known-group validity was tested by comparing out-patients with bipolar disorder (n=27), unipolar depression (n=8) healthy controls (n=68). The convergent and divergent validity of MOODS-LW were evaluated using the Montgomery Åsberg Depression Rating Scale (MADRS), the Young-Ziegler Mania Rating Scale (YMRS) in outpatients as well the General Health Questionnaire (GHQ-12) in healthy controls. Results: Both MOODS-LT and MOOODS-LW showed high internal consistency with the Kuder-Richardson coefficient ranging from 0.823 to 0.985 as well as consistent correlations for all domains and subdomains. The last-week version correlated significantly with MADRS (r= 0.79) and YMRS (r=0.46) in outpatients and with GHQ-12 (r= 0.50 for depression domain, r= 0.29 for rhythmicity) in healthy controls. Conclusion: The Swedish version of the MOODS-LT showed similar psychometric properties to other translated versions. Regarding MOODS-LW, this first published psychometric evaluation of the scale showed promising psychometric properties including good correlation to established symptom assessment scales. In healthy controls, the depression and rhythmicity domain scores of the last-week version correlated significantly with the occurrence of mild psychological distress. PMID:27346997

  12. 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

  13. Determining the non-inferiority margin for patient reported outcomes.

    PubMed

    Gerlinger, Christoph; Schmelter, Thomas

    2011-01-01

    One of the cornerstones of any non-inferiority trial is the choice of the non-inferiority margin delta. This threshold of clinical relevance is very difficult to determine, and in practice, delta is often "negotiated" between the sponsor of the trial and the regulatory agencies. However, for patient reported, or more precisely patient observed outcomes, the patients' minimal clinically important difference (MCID) can be determined empirically by relating the treatment effect, for example, a change on a 100-mm visual analogue scale, to the patient's satisfaction with the change. This MCID can then be used to define delta. We used an anchor-based approach with non-parametric discriminant analysis and ROC analysis and a distribution-based approach with Norman's half standard deviation rule to determine delta in three examples endometriosis-related pelvic pain measured on a 100-mm visual analogue scale, facial acne measured by lesion counts, and hot flush counts. For each of these examples, all three methods yielded quite similar results. In two of the cases, the empirically derived MCIDs were smaller or similar of deltas used before in non-inferiority trials, and in the third case, the empirically derived MCID was used to derive a responder definition that was accepted by the FDA. In conclusion, for patient-observed endpoints, the delta can be derived empirically. In our view, this is a better approach than that of asking the clinician for a "nice round number" for delta, such as 10, 50%, π, e, or i. PMID:21932298

  14. Hypoglycaemic events in patients with type 2 diabetes in the United Kingdom: associations with patient-reported outcomes and self-reported HbA1c

    PubMed Central

    2013-01-01

    Background One possible barrier to effective diabetes self-management is hypoglycaemia associated with diabetes medication. The current study was conducted to characterize hypoglycaemic events among UK patients with type 2 diabetes (T2D) treated with antihyperglycaemic medications, and assess the relationship between experience of hypoglycaemic events and health outcomes, including glycaemic control, health-related quality of life, impairment to work and non-work activities, treatment satisfaction, adherence to treatment, fear of hypoglycaemia, and healthcare resource use. Methods An online survey of 1,329 T2D patients in UK drawn from an opt-in survey panel was conducted in February of 2012 with monthly follow-up questionnaires for five months. Measures included self-reported HbA1c, EQ-5D, Work Productivity and Activity Impairment questionnaire, Diabetes Medication Satisfaction Tool, Morisky medication adherence scale, the Hypoglycaemia Fear Survey (revised), and self-reported healthcare resource use. Comparisons were conducted using t-tests and chi-square tests for continuous and categorical variables, respectively. Results Baseline comparisons showed that worse HbA1c, greater diabetes-related healthcare resource use, greater fear of hypoglycaemia, and impaired health outcomes were associated with experience of hypoglycaemia in the four weeks prior to baseline. Longitudinal results were similar in direction but differences on few measures were significant. Conclusions In real-world UK T2D patients, hypoglycaemia is associated with worse self-reported glycaemic control, behaviours that contribute to worse glycaemic control, and impairment in patient-reported outcomes. PMID:24351086

  15. The VVSymQ® instrument: Use of a new patient-reported outcome measure for assessment of varicose vein symptoms

    PubMed Central

    Turner-Bowker, Diane M; Elash, Celeste A; Wright, David

    2015-01-01

    Introduction No existing patient-reported outcome instrument focuses solely on assessment of varicose veins symptoms that are bothersome to patients. Methods The VVSymQ® instrument is a five-item patient-reported outcome that assesses symptoms most important to patients with varicose veins (heaviness, achiness, swelling, throbbing and itching). This paper describes how the VVSymQ® instrument was incorporated into an electronic daily diary to monitor key outcomes over time and capture treatment benefit in two randomized, controlled, phase 3 clinical trials. Results Patients were highly compliant in completing the electronic daily diary, and the VVSymQ® instrument demonstrated ability to detect overall change and ability to detect change that is meaningful to patients. Conclusion The VVSymQ® instrument is a reliable, valid instrument responsive to measuring change in the patient experience of varicose vein symptoms pre- and post-intervention, and is uniquely focused on patient-reported symptoms compared with other widely used questionnaires completed by clinicians. PMID:26183669

  16. 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

  17. Patient-reported outcomes and the evolution of adverse event reporting in oncology.

    PubMed

    Trotti, Andy; Colevas, A Dimitrios; Setser, Ann; Basch, Ethan

    2007-11-10

    Adverse event (AE) reporting in oncology has evolved from informal descriptions to a highly systematized process. The Common Terminology Criteria for Adverse Events (CTCAE) is the predominant system for describing the severity of AEs commonly encountered in oncology clinical trials. CTCAE clinical descriptors have been developed empirically during more than 30 years of use. The method of data collection is clinician based. Limitations of the CTC system include potential for incomplete reporting and limited guidance on data analysis and presentation methods. The Medical Dictionary for Regulatory Activities (MedDRA) is a comprehensive medical terminology system used for regulatory reporting and drug labeling. MedDRA does not provide for severity ranking of AEs. CTC-based data presentations are the primary method of AE data reporting used in scientific journals and oncology meetings. Patient-reported outcome instruments (PROs) cover the subjective domain of AEs. Exploratory work suggests PROs can be used with a high degree of patient engagement and compliance. Additional studies are needed to determine how PROs can be used to complement current AE reporting systems. Potential models for integrating PROs into AE reporting are described in this review. AE reporting methods will continue to evolve in response to changing therapies and growing interest in measuring the impact of cancer treatment on health status. Although integration of PROs into AE reporting may ultimately improve the comprehensiveness and quality of collected data, it may also increase the administrative burden and cost of conducting trials. Therefore, care must be used when developing health outcomes and safety data collection plans. PMID:17991931

  18. 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…

  19. Measurement equivalence of the KINDL questionnaire across child self-reports and parent proxy-reports: a comparison between item response theory and ordinal logistic regression.

    PubMed

    Jafari, Peyman; Sharafi, Zahra; Bagheri, Zahra; Shalileh, Sara

    2014-06-01

    Measurement equivalence is a necessary assumption for meaningful comparison of pediatric quality of life rated by children and parents. In this study, differential item functioning (DIF) analysis is used to examine whether children and their parents respond consistently to the items in the KINDer Lebensqualitätsfragebogen (KINDL; in German, Children Quality of Life Questionnaire). Two DIF detection methods, graded response model (GRM) and ordinal logistic regression (OLR), were applied for comparability. The KINDL was completed by 1,086 school children and 1,061 of their parents. While the GRM revealed that 12 out of the 24 items were flagged with DIF, the OLR identified 14 out of the 24 items with DIF. Seven items with DIF and five items without DIF were common across the two methods, yielding a total agreement rate of 50 %. This study revealed that parent proxy-reports cannot be used as a substitute for a child's ratings in the KINDL.

  20. 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…

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

    ERIC Educational Resources Information Center

    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…

  2. 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

  3. Multidisciplinary rehabilitation can impact on health-related quality of life outcome in radical cystectomy: secondary reported outcome of a randomized controlled trial

    PubMed Central

    Jensen, Bente Thoft; Jensen, Jørgen Bjerggaard; Laustsen, Sussie; Petersen, Annemette Krintel; Søndergaard, Ingrid; Borre, Michael

    2014-01-01

    Purpose Health related quality of life (HRQoL) is an important outcome in cancer care, although it is not well reported in surgical uro-oncology. Radical cystectomy (RC) with lymph-node dissection is the standard treatment of muscle-invasive bladder cancer and high-risk noninvasive bladder cancer. A wide range of impairments are reported postsurgery. The aims were to evaluate whether a standardized pre- and postoperative physical exercise program and enhanced mobilization can impact on HRQoL and inpatient satisfaction in RC, as defined by the European Organisation for Research and Treatment of Cancer (EORTC). Materials and methods Patients were randomized to fast-track RC and intervention (nI=50) or fast-track standard treatment (nS=57). HRQoL and inpatient satisfaction was measured using valid questionnaires: EORTC Quality of Life Questionnaire Core 30 (QLQ-C30) combined with the disease-specific EORTC BLS24 (baseline), and EORTC BLM30 (follow-up), and IN-PATSAT32 inpatient-satisfaction survey at discharge. Efficacy was defined as the differences in HRQoL-scores between treatment groups at the 4-month follow-up. Results The intervention group significantly improved HRQoL scores in dyspnea (P≤0.05), constipation (P<0.02), and abdominal flatulence (P≤0.05) compared to the standard group. In contrast, the standard group reported significantly reduced symptoms in sleeping pattern (P≤0.04) and clinically relevant differences in role function, body function, and fatigue. The intervention did not compromise inpatient satisfaction. Conclusion We found no overall impact on global HRQoL due to a physical rehabilitation program. However, pre- and postoperative physical rehabilitation can significantly and positively impact on HRQoL aspects related to bowel management and respiratory function (dyspnea) without compromising inpatient satisfaction. These results highlight the role of multimodal rehabilitation, including physical exercises in fast-track RC. PMID:25075194

  4. 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

  5. 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

  6. 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

  7. 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…

  8. An Introduction to Item Response Theory for Patient-Reported Outcome Measurement

    PubMed Central

    Nguyen, Tam H.; Han, Hae-Ra; Kim, Miyong T.

    2015-01-01

    The growing emphasis on patient-centered care has accelerated the demand for high-quality data from patient-reported outcome (PRO) measures. Traditionally, the development and validation of these measures has been guided by classical test theory. However, item response theory (IRT), an alternate measurement framework, offers promise for addressing practical measurement problems found in health-related research that have been difficult to solve through classical methods. This paper introduces foundational concepts in IRT, as well as commonly used models and their assumptions. Existing data on a combined sample (n = 636) of Korean American and Vietnamese American adults who responded to the High Blood Pressure Health Literacy Scale and the Patient Health Questionnaire-9 are used to exemplify typical applications of IRT. These examples illustrate how IRT can be used to improve the development, refinement, and evaluation of PRO measures. Greater use of methods based on this framework can increase the accuracy and efficiency with which PROs are measured. PMID:24403095

  9. 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…

  10. 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

  11. A review of the most common patient-reported outcomes in COPD--revisiting current knowledge and estimating future challenges.

    PubMed

    Cazzola, Mario; Hanania, Nicola Alexander; MacNee, William; Rüdell, Katja; Hackford, Claire; Tamimi, Nihad

    2015-01-01

    Patient-reported outcome (PRO) measures that quantify disease impact have become important measures of outcome in COPD research and treatment. The objective of this literature review was to comprehensively evaluate psychometric properties of available PRO instruments and the ability of each of them to characterize pharmaceutical treatment effects from published clinical trial evidence. Identified in this study were several PRO measures, both those that have been used extensively in COPD clinical trials (St George's Respiratory Questionnaire and Chronic Respiratory Questionnaire) and new instruments whose full value is still to be determined. This suggests a great need for more information about the patient experience of treatment benefit, but this also may pose challenges to researchers, clinicians, and other important stakeholders (eg, regulatory agencies, pharmaceutical companies) who develop new treatment entities and payers (including but not limited to health technology assessment agencies such as the National Institute for Health and Care Excellence and the Canadian Agency for Drugs and Technologies in Health). The purpose of this review is to enable researchers and clinicians to gain a broad overview of PRO measures in COPD by summarizing the value and purpose of these measures and by providing sufficient detail for interested audiences to determine which instrument may be the most suitable for evaluating a particular research purpose.

  12. Donor organ distribution according to urgency of need or outcome maximization in liver transplantation. A questionnaire survey among patients and medical staff.

    PubMed

    Umgelter, Katrin S; Tobiasch, Moritz; Anetsberger, Aida; Blobner, Manfred; Thorban, Stefan; Umgelter, Andreas

    2015-04-01

    Low donor rates in Germany cause a trade-off between equity in the distribution of chances for survival and efficiency in dead-donor liver transplantation. Public attitudes concerning the principles that should govern organ allocation are of interest. We performed a questionnaire-based study among patients and medical staff. 1826 of 2200 questionnaires were returned. 79.2%, 67.1%, and 24.4% patients wanted to accept liver transplantation for themselves if expected 1-year survival was 80%, 50%, and 20%, respectively. 57.7% affirmed 'averting immediate risk of death (urgency) is a more important criterion for organ allocation than expected long-term success' (P = 0.002 against indifference). The majority of medical staff took the opposite decision. 20.7%, 8.8%, and 21.2% of patients chose 50%, 33%, and 10% as lowest acceptable 5-year survival, respectively. 49.3% accepted a survival of <10%. Variables associated with preferring urgency over efficiency as criterion for allocation were age (OR 1.009; 95% CI: 1.000-1.017; female gender (OR 1.331; 95%CI 0.992-1.784); higher education (OR 0.881; 95%CI 0.801-0.969); and refusal of transplantation for oneself (OR 1.719; 95%CI 1.272-2.324). Most patients supported urgency-based liver allocation. Patients and medical staff would accept lower survival rates than the transplant community. PMID:25557453

  13. Measuring and Predicting Patient Dissatisfaction after Anterior Urethroplasty Using Patient Reported Outcomes Measures

    PubMed Central

    Bertrand, Laura A.; Voelzke, Bryan B.; Elliott, Sean P.; Myers, Jeremy B.; Breyer, Benjamin N.; Vanni, Alex J.; McClung, Christopher D.; Tam, Christopher A.; Warren, Gareth J.; Erickson, Bradley A.

    2016-01-01

    Purpose Subjective measures of success after urethroplasty have become increasingly valuable in postoperative monitoring. We examined patient reported satisfaction following anterior urethroplasty using objective measures as a proxy for success. Materials and Methods Men 18 years old or older with urethral strictures undergoing urethroplasty were prospectively enrolled in a longitudinal, multi-institutional urethroplasty outcomes database. Preoperative and postoperative assessment included questionnaires to assess lower urinary tract symptoms, pain, satisfaction and sexual health. Analyses controlling for stricture recurrence (defined as the inability to traverse the reconstructed urethra with a flexible cystoscope) were performed to determine independent predictors of dissatisfaction. Results At a mean followup of 14 months we found a high 89.4% rate of overall postoperative satisfaction in 433 patients and a high 82.8% rate in those who would have chosen the operation again. Men with cystoscopic recurrence were more likely to report dissatisfaction (OR 4.96, 95% CI 2.07–11.90) and men reporting dissatisfaction had significantly worse uroflowmetry measures (each p <0.02). When controlling for recurrence, multivariate analysis revealed that urethra and bladder pain (OR 1.71, 95% CI 1.05–2.77 and OR 2.74, 95% CI 1.12–6.69, respectively), a postoperative decrease in sexual activity (OR 4.36, 95% CI 2.07–11.90) and persistent lower urinary tract symptoms (eg straining to urinate OR 3.23, 1.74-6.01) were independent predictors of dissatisfaction. Conclusions Overall satisfaction after anterior urethroplasty is high and traditional measures of surgical success strongly correlate with satisfaction. However, independently of the anatomical appearance of the reconstructed urethra, postoperative pain, sexual dysfunction and persistent lower urinary tract symptoms were predictors of patient dissatisfaction. PMID:26907509

  14. 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…

  15. 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…

  16. The Cluster Analysis of Jobs Based on Data from the Position Analysis Questionnaire (PAQ). Report No. 7.

    ERIC Educational Resources Information Center

    DeNisi, Angelo S.; McCormick, Ernest J.

    The Position Analysis Questionnaire (PAQ) is a structured job analysis procedure that provides for the analysis of jobs in terms of each of 187 job elements, these job elements being grouped into six divisions: information input, mental processes, work output, relationships with other persons, job context, and other job characteristics. Two…

  17. The Job Dimensions Underlying the Job Elements of the Position Analysis Questionnaire (PAQ) (Form B). Report No. 4.

    ERIC Educational Resources Information Center

    Marquardt, Lloyd D.; McCormick, Ernest J.

    This study was concerned with the identification of the job dimension underlying the job elements of the Position Analysis Questionnaire (PAQ), Form B. The PAQ is a structured job analysis instrument consisting of 187 worker-oriented job elements which are divided into six a priori major divisions. The statistical procedure of principal components…

  18. 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…

  19. 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

  20. 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

  1. 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…

  2. Radiotherapy in implant-based immediate breast reconstruction: risk factors, surgical outcomes, and patient-reported outcome measures in a large Swedish multicenter cohort.

    PubMed

    Eriksson, Max; Anveden, Lotta; Celebioglu, Fuat; Dahlberg, Kristina; Meldahl, Ingrid; Lagergren, Jakob; Eriksen, Catharina; de Boniface, Jana

    2013-12-01

    The purpose of this large cohort study was to analyze the effects of prior and postoperative radiotherapy (RT) on surgical outcomes and patient-reported outcome measures (PROMs) in implant-based immediate breast reconstruction (IBR). All breast cancer patients (n = 725, of whom 29 had bilateral IBR) operated with implant-based IBR at four Stockholm hospitals from 2007 to 2011 were included. The median follow-up was 43 months. Three groups were compared: no RT (n = 386), prior RT (n = 64), and postoperative RT (n = 304). Outcomes were IBR failure (implant loss with or without secondary autologous reconstruction), unplanned reoperations, and PROMs, as measured by the BreastQ(®) questionnaire. IBR failure occurred in 22/386 (6 %) of non-irradiated cases, 16/64 (25 %) after prior and 45/304 (15 %) after postoperative RT (p < 0.001). Failure risk was higher after prior than postoperative RT (HR 9.28 vs. 3.08). Further risk factors were high BMI, less surgeon reconstructive experience, and postoperative infection, while the use of permanent implants lowered the risk of IBR failure. The estimated 5 years IBR failure rate was 10.4 % for non-irradiated, 28.2 % for previously and 25.2 % for postoperatively irradiated patients (p < 0.001). At least one unplanned reoperation occurred in 169/384 of non-irradiated (44 %), 42/64 (66 %) of previously, and 180/303 (59 %) of postoperatively irradiated breasts (p < 0.001). Further contributing factors were the use of one-stage expander and permanent implants, less surgeon reconstructive experience, and smoking. RT significantly impaired scores on all scales of the BreastQ(®). However, a clear majority of women in all groups would choose IBR again. Implant-based IBR remains a feasible option for women undergoing mastectomy as patient satisfaction levels are high. After prior RT, however, autologous alternatives should be considered.

  3. Sensitivity Analysis for Nonignorable Missingness and Outcome Misclassification from Proxy Reports

    PubMed Central

    Shardell, Michelle; Simonsick, Eleanor; Hicks, Gregory E.; Resnick, Barbara; Ferrucci, Luigi; Magaziner, Jay

    2013-01-01

    Researchers often recruit proxy respondents, such as relatives or caregivers, for epidemiologic studies of older adults when study participants are unable to provide self-reports (e.g., due to illness or cognitive impairment). In most studies involving proxy-reported outcomes, proxies are recruited only to report on behalf of participants who have missing self-reported outcomes; thus, either a proxy report or participant self-report, but not both, is available for each participant. When outcomes are binary and investigators conceptualize participant self-reports as gold standard measures, substituting proxy reports in place of missing participant self-reports in statistical analysis can introduce misclassification error and lead to biased parameter estimates. However, excluding observations from participants with missing self-reported outcomes may also lead to bias. We propose a pattern-mixture model that uses error-prone proxy reports to reduce selection bias from missing outcomes, and we describe a sensitivity analysis to address bias from differential outcome misclassification. We perform model estimation with high-dimensional (e.g., continuous) covariates using propensity-score stratification and multiple imputation. We apply the methods to the Second Cohort of the Baltimore Hip Studies, a study of elderly hip-fracture patients, to assess the relation between type of surgical treatment and perceived physical recovery. Simulation studies show that the proposed methods perform well. We provide SAS programs in the eAppendix to enhance the methods’ accessibility. PMID:23348065

  4. Post-Inpatient Brain Injury Rehabilitation Outcomes: Report from the National OutcomeInfo Database.

    PubMed

    Malec, James F; Kean, Jacob

    2016-07-15

    This study examined outcomes for intensive residential and outpatient/community-based post-inpatient brain injury rehabilitation (PBIR) programs compared with supported living programs. The goal of supported living programs was stable functioning (no change). Data were obtained for a large cohort of adults with acquired brain injury (ABI) from the OutcomeInfo national database, a web-based database system developed through National Institutes of Health (NIH) Small Business Technology Transfer (STTR) funding for monitoring progress and outcomes in PBIR programs primarily with the Mayo-Portland Adaptability Inventory (MPAI-4). Rasch-derived MPAI-4 measures for cases from 2008 to 2014 from 9 provider organizations offering programs in 23 facilities throughout the United States were examined. Controlling for age at injury, time in program, and time since injury on admission (chronicity), both intensive residential (n = 205) and outpatient/community-based (n = 2781) programs resulted in significant (approximately 1 standard deviation [SD]) functional improvement on the MPAI-4 Total Score compared with supported living (n = 101) programs (F = 18.184, p < 0.001). Intensive outpatient/community-based programs showed greater improvements on MPAI-4 Ability (F = 14.135, p < 0.001), Adjustment (F = 12.939, p < 0.001), and Participation (F = 16.679, p < 0.001) indices than supported living programs; whereas, intensive residential programs showed improvement primarily in Adjustment and Participation. Age at injury and time in program had small effects on outcome; the effect of chronicity was small to moderate. Examination of more chronic cases (>1 year post-injury) showed significant, but smaller (approximately 0.5 SD) change on the MPAI-4 relative to supported living programs (F = 17.562, p < 0.001). Results indicate that intensive residential and outpatient/community-based PIBR programs result in substantial positive

  5. High levels of low energy reporting on 24-hour recalls and three questionnaires in an elderly low-socioeconomic status population.

    PubMed

    Tooze, Janet A; Vitolins, Mara Z; Smith, Shannon L; Arcury, Thomas A; Davis, Cralen C; Bell, Ronny A; DeVellis, Robert F; Quandt, Sara A

    2007-05-01

    Studies of low energy reporting in the elderly are limited, yet changes in energy balance and the incidence of chronic disease make this a critical time to assess energy intake in this population. The objective of this study was to assess low energy reporting on 24-h recalls (24HR), a FFQ, a picture sort FFQ (PSFFQ), and a meal pattern questionnaire (MPQ), and to relate low energy reporting status to personal characteristics and dietary characteristics, including the Healthy Eating Index. Monthly 24HR were completed over 6 mo, followed by 3 interviewer-administered questionnaires. The Goldberg equation was used to determine reporting status for the dietary assessment methods among older, rural, low socioeconomic status, white, African American, and Native American men and women. The relations of variables of interest to low energy reporting were considered one at a time and in multiple logistic regression models. The percentage of participants classified as accurate reporters varied from 40% (FFQ) to 63% (PSFFQ) among men and 60% (24HR, PSFFQ, MPQ) to 63% (FFQ) among women; high energy reporting was observed on the MPQ. Low energy reporters on the FFQ tended to be men and to be overweight or obese (P < 0.05). Underreporting seemed to be due to omitting foods from major food groups as well as from omitting discretionary energy foods. There was a high degree of low energy reporting in this population, particularly by men, even with six 24HR. PMID:17449594

  6. 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.

  7. 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.

  8. [Pelargonium sidoides in acute bronchitis - Health-related quality of life and patient-reported outcome in adults receiving EPs 7630 treatment].

    PubMed

    Matthys, Heinrich; Lizogub, Victor G; Funk, Petra; Malek, Fathi A

    2010-12-01

    Health-related quality of life (HRQL) and patient-reported outcome (PRO) have become important outcome parameters for the evaluation of medical treatment within clinical trials and, furthermore, to evaluate efficiency in clinical practice. We therefore report further exploratory results of an already reported dose-finding study with EPs 7630 tablets, now focussing on HRQL and PRO. A total of 406 adults with acute bronchitis were randomly assigned to one of four parallel treatment groups (placebo, 30 mg, 60 mg or 90 mg EPs 7630 daily). HRQL and PRO were assessed by questionnaires as secondary outcome measures at each study visit or daily in the patient's diary. At day 7, the patient-reported outcome measures were significantly more improved in all the three EPs 7630 groups compared to placebo (EQ-5D and EQ VAS, SF-12: physical score, impact of patient's sickness, duration of activity limitation, patient-reported treatment outcome, satisfaction with treatment). In conclusion, a statistically significant and clinically relevant improvement of HRQL/PRO compared to placebo was shown in all the three EPs 7630 groups.

  9. Planning and reporting of quality-of-life outcomes in cancer trials

    PubMed Central

    Schandelmaier, S.; Conen, K.; von Elm, E.; You, J. J.; Blümle, A.; Tomonaga, Y.; Amstutz, A.; Briel, M.; Kasenda, B.

    2015-01-01

    Background Information about the impact of cancer treatments on patients' quality of life (QoL) is of paramount importance to patients and treating oncologists. Cancer trials that do not specify QoL as an outcome or fail to report collected QoL data, omit crucial information for decision making. To estimate the magnitude of these problems, we investigated how frequently QoL outcomes were specified in protocols of cancer trials and subsequently reported. Design Retrospective cohort study of RCT protocols approved by six research ethics committees in Switzerland, Germany, and Canada between 2000 and 2003. We compared protocols to corresponding publications, which were identified through literature searches and investigator surveys. Results Of the 173 cancer trials, 90 (52%) specified QoL outcomes in their protocol, 2 (1%) as primary and 88 (51%) as secondary outcome. Of the 173 trials, 35 (20%) reported QoL outcomes in a corresponding publication (4 modified from the protocol), 18 (10%) were published but failed to report QoL outcomes in the primary or a secondary publication, and 37 (21%) were not published at all. Of the 83 (48%) trials that did not specify QoL outcomes in their protocol, none subsequently reported QoL outcomes. Failure to report pre-specified QoL outcomes was not associated with industry sponsorship (versus non-industry), sample size, and multicentre (versus single centre) status but possibly with trial discontinuation. Conclusions About half of cancer trials specified QoL outcomes in their protocols. However, only 20% reported any QoL data in associated publications. Highly relevant information for decision making is often unavailable to patients, oncologists, and health policymakers. PMID:26133966

  10. 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

  11. 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.

  12. Patient-reported outcomes of caries prophylaxis among Swedish caries active adults in a long-term perspective.

    PubMed

    Flink, Håkan; Tegelberg, Åke; Arnetz, Judy; Birkhed, Dowen

    2016-01-01

    The aim of this study was to measure patient-reported outcomes of caries prophylaxis and to compare them with previously documented efforts in dental offices. A questionnaire was mailed to 134 caries active (CA) and 40 caries inactive (CI) adult patients treated at a Swedish public dental service clinic. The overall response rate was 69%. The questionnaire included items regarding patient perceived caries prophylaxis in relation to: 1) treatment and recommendations given by the dental personnel, 2) performed self-care and 3) perceived and expected effects.The responses were studied for their association to clinical data, extracted retrospectively from the patients' dental records.The mean follow up time was > 16 years. Information about caries prophylaxis (p = 0.01) and recommendations for self-care (p = 0.04) were given more often to the CA group than to the CI group. Supplementary examinations and recommendations of self-care risk treatments were more frequent in the CA group (p < 0.001). CA patients also made more frequent extra efforts at home to avoid caries by changing their eating habits (p < 0.001), improving their oral hygiene (p = 0.04) and using extra fluoride (p = 0.001). In the CA group, 60% did not considerthat the extra prophylaxis efforts had made them caries inactive, and 40% were not satisfied with the outcome. Most patients (> 90%) hoped that the outcome of caries prophylactics would be a reduced number of cavities.The patient-perceived experiences of caries prophylaxis-were in concordance with dental records. Both the dentists and the caries active middle-aged Swedish adults were aware of the need for extra prophylaxis.The caries active patients perceived having made extra home care efforts, but had not experienced that they had become free from caries. PMID:27464386

  13. CLASSIFICATION OF IRANIAN NURSES ACCORDING TO THEIR MENTAL HEALTH OUTCOMES USING GHQ-12 QUESTIONNAIRE: A COMPARISON BETWEEN LATENT CLASS ANALYSIS AND K-MEANS CLUSTERING WITH TRADITIONAL SCORING METHOD

    PubMed Central

    Jamali, Jamshid; Ayatollahi, Seyyed Mohammad Taghi

    2015-01-01

    Background: Nurses constitute the most providers of health care systems. Their mental health can affect the quality of services and patients’ satisfaction. General Health Questionnaire (GHQ-12) is a general screening tool used to detect mental disorders. Scoring method and determining thresholds for this questionnaire are debatable and the cut-off points can vary from sample to sample. This study was conducted to estimate the prevalence of mental disorders among Iranian nurses using GHQ-12 and also compare Latent Class Analysis (LCA) and K-means clustering with traditional scoring method. Methodology: A cross-sectional study was carried out in Fars and Bushehr provinces of southern Iran in 2014. Participants were 771 Iranian nurses, who filled out the GHQ-12 questionnaire. Traditional scoring method, LCA and K-means were used to estimate the prevalence of mental disorder among Iranian nurses. Cohen’s kappa statistic was applied to assess the agreement between the LCA and K-means with traditional scoring method of GHQ-12. Results: The nurses with mental disorder by scoring method, LCA and K-mean were 36.3% (n=280), 32.2% (n=248), and 26.5% (n=204), respectively. LCA and logistic regression revealed that the prevalence of mental disorder in females was significantly higher than males. Conclusion: Mental disorder in nurses was in a medium level compared to other people living in Iran. There was a little difference between prevalence of mental disorder estimated by scoring method, K-means and LCA. According to the advantages of LCA than K-means and different results in scoring method, we suggest LCA for classification of Iranian nurses according to their mental health outcomes using GHQ-12 questionnaire PMID:26622202

  14. Patient-reported outcomes in studies of complementary and alternative medicine: problems, solutions, and future directions.

    PubMed

    Eton, David T; Bauer, Brent A; Sood, Amit; Yost, Kathleen J; Sloan, Jeff A

    2011-01-01

    Patient-reported outcome (PRO) measures are frequently used to assess therapeutic efficacy and effectiveness of complementary and alternative medicine (CAM). Although CAM investigators are increasingly making use of valid, self-report instruments to assess patient-relevant outcomes, the sheer number of available instruments poses challenges. Two of the more pressing issues are discussed: the lack of guidance for selecting measures and the limited attention paid to the clinical meaningfulness of PRO results. Solutions are offered that may support selection and standardization of outcome measures for future CAM studies. This includes testing of tools from the National Institutes of Health's Patient-Reported Outcomes Measurement Information System (PROMIS). Increased standardization of outcome measurement in CAM studies will allow for more cross-study comparisons and facilitate the statistical pooling of results, ultimately leading to a more informative evidence base.

  15. District Improvement Outcomes: 2010-11. Impact Evaluation. D&A Report No. 11.21

    ERIC Educational Resources Information Center

    Paeplow, Colleen

    2011-01-01

    In 2010-11, Wake County Public School System (WCPSS) was in district-wide improvement as a result of failing to meet Adequate Yearly Progress (AYP) in mathematics at the district level for the second consecutive year. This report examines student outcomes in 2010-11 as well as overall teacher outcomes and longitudinal results for schools targeted…

  16. 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

  17. 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

  18. The menstrual attitude questionnaire.

    PubMed

    Brooks-Gunn, J; Ruble, D N

    1980-09-01

    In order to examine the relationship of attitudes about menstruation to self-reports of menstrual-related symptomatology as well as to other aspects of behavior, an instrument to measure attitudes concerning menstruation was developed. After constructing the Menstrual Attitude Questionnaire (MAQ), the factor analytic structure of the original MAQ sample was replicated on a second sample. Summary statistics are presented for college women, college men, and adolescent girls, and the relationship between menstrual-related attitudes, expectations, and experience is examined.

  19. Brief report: the Ego Identity Process Questionnaire: factor structure, reliability, and convergent validity in Dutch-speaking late adolescents.

    PubMed

    Luyckx, Koen; Goossens, Luc; Beyers, Wim; Soenens, Bart

    2006-02-01

    The reliability and validity of a Dutch version of the Ego Identity Process Questionnaire (EIPQ) were evaluated. In Study 1, the instrument was found to exhibit a clear factor structure and acceptable reliability. Using Confirmatory Factor Analysis, both a model with two process factors (Commitment, Exploration) and a model with four content factors (Ideological Commitment, Ideological Exploration, Interpersonal Commitment, Interpersonal Exploration) evidenced a good fit once direction of wording was taken into account. In Study 2, moderate convergence was observed between Commitment and Exploration, and continuous measures of identity statuses and identity styles. The results of both studies combined indicated that the Dutch version of the EIPQ may be recommended as a research tool with college students.

  20. Psoriatic Arthritis Screening and Evaluation (PASE) questionnaire and the role of dermatologists: a report from the GRAPPA 2009 annual meeting.

    PubMed

    Dominguez, Patrick; Husni, M Elaine; Garg, Amit; Qureshi, Abrar A

    2011-03-01

    Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis, often with a variable course that ranges from slowly progressive to rapidly destructive. Delay in diagnosis and treatment may lead to an irreversible erosive arthropathy, leading further to physical disability and deformity. The Psoriatic Arthritis Screening and Evaluation (PASE) tool was developed and validated to help dermatologists screen more effectively for PsA; recently, it has been undergoing further validation. An update on the continuing experience with the PASE questionnaire, along with a discussion of why dermatologists have a critical role in screening for PsA, was a major focus of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) annual meeting at Stockholm, Sweden, in June 2009.

  1. 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

  2. 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. PMID:27525737

  3. Socket Interface Pressure and Amputee Reported Outcomes for Comfortable and Uncomfortable Conditions of Patellar Tendon Bearing Socket: A Pilot Study.

    PubMed

    Safari, Mohammad Reza; Tafti, Nahid; Aminian, Gholamreza

    2015-01-01

    The objectives of the current study were to compare intra-socket pressure differences between comfortable and uncomfortable socket conditions, and the usefulness of subject perception of satisfaction, activity limitations, and socket comfort in distinguishing between these two socket conditions. Five unilateral trans-tibial amputees took part in the study. They answered the Socket Comfort Score (SCS) and Trinity Amputation and Prosthetic Experience Scale (TAPES) questionnaires before the interface pressure (in standing and walking) was measured for the uncomfortable socket condition at five regions of the residual limb. Participants were then provided with a comfortable socket and wore it for two weeks. Participants who were satisfied with the socket fit after two weeks repeated the SCS and TAPES questionnaires and interface pressure measurements. The differences between the test results of the two conditions were not statistically significant, except for the interface pressure at the popliteal region during the early stance phase, TAPES socket fit subscale, and the SCS. Due to large variability of the data and the lack of statistical significance, no firm conclusion can be made on the possible relationship between the interface pressure values and the patient-reported outcomes of the two socket conditions. A larger sample size and longer acclimation period are required to locate significant differences.

  4. 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.

  5. Yoga & cancer interventions: a review of the clinical significance of patient reported outcomes for cancer survivors.

    PubMed

    Culos-Reed, S Nicole; Mackenzie, Michael J; Sohl, Stephanie J; Jesse, Michelle T; Zahavich, Ashley N Ross; Danhauer, Suzanne C

    2012-01-01

    Limited research suggests yoga may be a viable gentle physical activity option with a variety of health-related quality of life, psychosocial and symptom management benefits. The purpose of this review was to determine the clinical significance of patient-reported outcomes from yoga interventions conducted with cancer survivors. A total of 25 published yoga intervention studies for cancer survivors from 2004-2011 had patient-reported outcomes, including quality of life, psychosocial or symptom measures. Thirteen of these studies met the necessary criteria to assess clinical significance. Clinical significance for each of the outcomes of interest was examined based on 1 standard error of the measurement, 0.5 standard deviation, and relative comparative effect sizes and their respective confidence intervals. This review describes in detail these patient-reported outcomes, how they were obtained, their relative clinical significance and implications for both clinical and research settings. Overall, clinically significant changes in patient-reported outcomes suggest that yoga interventions hold promise for improving cancer survivors' well-being. This research overview provides new directions for examining how clinical significance can provide a unique context for describing changes in patient-reported outcomes from yoga interventions. Researchers are encouraged to employ indices of clinical significance in the interpretation and discussion of results from yoga studies. PMID:23125870

  6. Yoga & Cancer Interventions: A Review of the Clinical Significance of Patient Reported Outcomes for Cancer Survivors

    PubMed Central

    Culos-Reed, S. Nicole; Mackenzie, Michael J.; Sohl, Stephanie J.; Jesse, Michelle T.; Zahavich, Ashley N. Ross; Danhauer, Suzanne C.

    2012-01-01

    Limited research suggests yoga may be a viable gentle physical activity option with a variety of health-related quality of life, psychosocial and symptom management benefits. The purpose of this review was to determine the clinical significance of patient-reported outcomes from yoga interventions conducted with cancer survivors. A total of 25 published yoga intervention studies for cancer survivors from 2004–2011 had patient-reported outcomes, including quality of life, psychosocial or symptom measures. Thirteen of these studies met the necessary criteria to assess clinical significance. Clinical significance for each of the outcomes of interest was examined based on 1 standard error of the measurement, 0.5 standard deviation, and relative comparative effect sizes and their respective confidence intervals. This review describes in detail these patient-reported outcomes, how they were obtained, their relative clinical significance and implications for both clinical and research settings. Overall, clinically significant changes in patient-reported outcomes suggest that yoga interventions hold promise for improving cancer survivors' well-being. This research overview provides new directions for examining how clinical significance can provide a unique context for describing changes in patient-reported outcomes from yoga interventions. Researchers are encouraged to employ indices of clinical significance in the interpretation and discussion of results from yoga studies. PMID:23125870

  7. What has to happen before we report radical prostatectomy outcomes of individual surgeons to the public?

    PubMed Central

    Vickers, Andrew; Eastham, James

    2010-01-01

    Summary It would appear entirely uncontroversial to suggest that prostate cancer patients should have available information on surgeon outcomes so that they can make informed treatment decisions. We argue that release of surgeon-level data on radical prostatectomy outcomes would be premature at the current time. We point to a series of problems that would need to be addressed before we could be sure that a consumerist approach to surgeon selection would do more good than harm. These include non-standardized reporting of endpoints such as urinary and erectile function, statistically unreliable estimates from low volume surgeons and perverse incentives, such as referring of high risk patients to radiotherapy. We recommend an alternative to the “name-and-shame” paradigm of public outcomes reporting: continuous quality improvement. Surgeons are given reports as to their own outcomes on a private basis, such that no-one else can see their data. This helps to build trust and to avoid perverse incentives. Such reports must be multi-dimensional and based on a comprehensive, patient-reported outcomes system. As outcomes data are meaningless for low volume surgeons, these surgeons would have to choose between focusing on radical prostatectomy and referring patients to higher volume colleagues. Systematic research is required to determine whether such an approach would do more good than harm. PMID:20884248

  8. A multisite validity study of self-reported anesthesia outcomes.

    PubMed

    Walker, Peter; Pekmezaris, Renee; Lesser, Martin L; Nouryan, Christian N; Rosinia, Frank; Pratt, Kathy; LaVopa, Catherine

    2012-01-01

    The purpose of this study was to assess the validity of a multisite anesthesia voluntary adverse event reporting process. A data validation methodology was used through medical chart review on live records at 3 facilities (N = 600). The per-item aggregated error rate among all 42 data items was 0.3%: 0.1% for quality indicators, 1.3% for demographic/status variables, and 1.7% for administrative items. The per-patient error rate among all 42 data items was 6.3%: 3.0% for quality indicators, 1.7% for demographic/status variables, and 3.0% for administrative items. Trends such as better accuracy for more serious events continue, but observed error rates were lower than those found in previous surveys-an indication that, while further study is needed, nonpunitive voluntary reporting may reduce errors in anesthesia care. PMID:22326979

  9. Seizure metaphors in children with epilepsy: A study based on a multiple-choice self-report questionnaire.

    PubMed

    D'Angelosante, Valentina; Tommasi, Marco; Casadio, Claudia; Verrotti, Alberto

    2015-05-01

    The advantages of metaphorical representation are pointed out in many fields of clinical research (e.g. cancer, HIV, psychogenic nonepileptic seizures). This study aimed at offering a novel contribution showing how children with epilepsy describe the symptomatology of their seizure experiences by means of particular kinds of cognitive metaphors. Twenty-three children with idiopathic generalized epilepsy and thirty-one healthy children were recruited for this study and interviewed with a multiple-choice questionnaire asking them to describe their epileptic seizures by means of suitable metaphors. A psychologist blinded to medical diagnosis assessed and categorized all metaphors. By considering the 89 metaphors produced by the children with epilepsy and the 147 ones by the healthy controls, Agent/Force was the primary metaphor assessed by children with epilepsy, followed by Event/Situation as the second preference. Moreover, comparing the results of the control group with those of the subjects with epilepsy, it was found that controls were oriented towards selecting exogenous forces, while subjects with epilepsy tended to select endogenous forces. In particular, children with epilepsy showed a peculiar preference for an endogenous force resembling the waggle metaphor, which is similar to the effect of a quake's shaking (earthquake or seaquake). The metaphors identified by this research are a useful resource to better understand the seizure experiences of patients with epilepsy, helping to improve clinical treatment. PMID:25934584

  10. [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.

  11. Seizure metaphors in children with epilepsy: A study based on a multiple-choice self-report questionnaire.

    PubMed

    D'Angelosante, Valentina; Tommasi, Marco; Casadio, Claudia; Verrotti, Alberto

    2015-05-01

    The advantages of metaphorical representation are pointed out in many fields of clinical research (e.g. cancer, HIV, psychogenic nonepileptic seizures). This study aimed at offering a novel contribution showing how children with epilepsy describe the symptomatology of their seizure experiences by means of particular kinds of cognitive metaphors. Twenty-three children with idiopathic generalized epilepsy and thirty-one healthy children were recruited for this study and interviewed with a multiple-choice questionnaire asking them to describe their epileptic seizures by means of suitable metaphors. A psychologist blinded to medical diagnosis assessed and categorized all metaphors. By considering the 89 metaphors produced by the children with epilepsy and the 147 ones by the healthy controls, Agent/Force was the primary metaphor assessed by children with epilepsy, followed by Event/Situation as the second preference. Moreover, comparing the results of the control group with those of the subjects with epilepsy, it was found that controls were oriented towards selecting exogenous forces, while subjects with epilepsy tended to select endogenous forces. In particular, children with epilepsy showed a peculiar preference for an endogenous force resembling the waggle metaphor, which is similar to the effect of a quake's shaking (earthquake or seaquake). The metaphors identified by this research are a useful resource to better understand the seizure experiences of patients with epilepsy, helping to improve clinical treatment.

  12. Current-reported outcome domains in studies of adults with a focus on the treatment of tinnitus: protocol for a systematic review

    PubMed Central

    Hall, Deborah A; Szczepek, Agnieszka J; Kennedy, Veronica; Haider, Haúla

    2015-01-01

    Introduction In Europe alone, over 70 million people experience tinnitus. Despite its considerable socioeconomic relevance, progress in developing successful treatments has been limited. Clinical effectiveness is judged according to change in primary outcome measures, but because tinnitus is a subjective condition, the definition of outcomes is challenging and it remains unclear which distinct aspects of tinnitus (ie, ‘domains’) are most relevant for assessment. The development of a minimum outcome reporting standard would go a long way towards addressing these problems. In 2006, a consensus meeting recommended using 1 of 4 questionnaires for tinnitus severity as an outcome in clinical trials, in part because of availability in different language translations. Our initiative takes an approach motivated by clinimetrics, first by determining what to measure before seeking to determine how to measure it. Agreeing on the domains that contribute to tinnitus severity (ie, ‘what’) is the first step towards achieving a minimum outcome reporting standard for tinnitus that has been reached via a methodologically rigorous and transparent process. Methods and analysis Deciding what should be the core set of outcomes requires a great deal of discussion and so lends itself well to international effort. This protocol lays out the first-step methodology in defining a Core Domain Set for clinical trials of tinnitus by establishing existing knowledge and practice with respect to which outcome domains have been measured and which instruments used in recent registered and published clinical trials. Ethics and dissemination No ethical issues are foreseen. Findings will be reported at national and international ear, nose and throat (ENT) and audiology conferences and in a peer-reviewed journal, using PRISMA (Preferred Reporting Items for Systematic reviews and Meta-analysis) guidelines. Trial registration number The systematic review protocol is registered on PROSPERO

  13. The BODY-Q: A Patient-Reported Outcome Instrument for Weight Loss and Body Contouring Treatments

    PubMed Central

    Cano, Stefan J.; Alderman, Amy; Soldin, Mark; Thoma, Achilles; Robson, Sam; Kaur, Manraj; Papas, Athanasios; Van Laeken, Nancy; Taylor, Valerie H.; Pusic, Andrea L.

    2016-01-01

    Background: Body contouring performed for cosmetic purposes, or after weight loss, has the potential to improve body image and health-related quality of life (HRQL). The BODY-Q is a new patient-reported outcome (PRO) instrument designed to measure patient perceptions of weight loss and/or body contouring. In this article, we describe the psychometric properties of the BODY-Q scales after an international field-test. Methods: Weight loss and body contouring patients from Canada, United States, and United Kingdom were recruited between November 2013 and February 2015. Data were collected using an iPad directly into a web-based application or a questionnaire booklet. Rasch measurement theory analysis was used for item reduction and to examine reliability, validity, and ability to detect change. Results: The sample included 403 weight loss and 331 body contouring patients. Most BODY-Q items had ordered thresholds (134/138) and good item fit. Scale reliability was acceptable, ie, Person separation index >0.70 for 16 scales, Cronbach α ≥0.90 for 18 of 18 scales, and Test–retest ≥0.87 for 17 of 18 scales. Appearance and HRQL scores were lower in participants with more obesity-related symptoms, higher body mass index, and more excess skin and in those pre- versus postoperative body contouring. The 134 weight loss patients who completed the BODY-Q twice, either 6 weeks (weight loss/nonsurgical body contouring program) or 6 months (bariatric program) later, improved significantly on 7 appearance and 4 HRQL scales. Conclusion: The BODY-Q is a clinically meaningful and scientifically sound patient-reported outcome instrument that can be used to measure outcomes in patients who undergo weight loss and/or body contouring. PMID:27200241

  14. Outcome of mucormycosis after treatment: report of five cases.

    PubMed

    Bellazreg, F; Hattab, Z; Meksi, S; Mansouri, S; Hachfi, W; Kaabia, N; Ben Said, M; Letaief, A

    2015-07-01

    Mucormycoses are serious infections caused by filamentous fungi of the order Mucorales. They occur most often in immunocompromised patients. We report five cases of mucormycosis in patients hospitalized in the Infectious Diseases Department in Sousse - Tunisia between 2000 and 2013. They were 4 males and one female, mean age 60 years. Three patients were diabetic and one patient had acute leukemia. The locations of mucormycosis were rhinocerebral, rhino-orbital, auricular, pulmonary and cutaneous. The Mucorales isolated were Rhizopus arrhizus in 3 cases and Lichteimia in 2 cases. All patients were treated with amphotericin B and 2 patients had, in addition, surgical debridement. Two patients died and 2 kept peripheral facial paralysis.

  15. 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

  16. 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…

  17. Factor analysis of the self-report version of the strengths and difficulties questionnaire in a sample of children with intellectual disability.

    PubMed

    Haynes, Allison; Gilmore, Linda; Shochet, Ian; Campbell, Marilyn; Roberts, Clare

    2013-02-01

    The rate of emotional and behavioural disturbance in children with intellectual disability (ID) is up to four times higher than that of their typically developing peers. It is important to identify these difficulties in children with ID as early as possible to prevent the chronic co-morbidity of ID and psychopathology. Children with ID have traditionally been assessed via proxy reporting, but appropriate and psychometrically rigorous instruments are needed so that children can report on their own emotions and behaviours. In this study, the factor structure of the self-report version of the Strengths and Difficulties Questionnaire (SDQ) was examined in a population of 128 children with ID (mean age=12 years). Exploratory and Confirmatory Factor Analysis showed a three factor model (comprising Positive Relationships, Negative Behaviour and Emotional Competence) to be a better measure than the original five factor SDQ model in this population. PMID:23246559

  18. Outcome of mucormycosis after treatment: report of five cases

    PubMed Central

    Bellazreg, F.; Hattab, Z.; Meksi, S.; Mansouri, S.; Hachfi, W.; Kaabia, N.; Ben Said, M.; Letaief, A.

    2014-01-01

    Mucormycoses are serious infections caused by filamentous fungi of the order Mucorales. They occur most often in immunocompromised patients. We report five cases of mucormycosis in patients hospitalized in the Infectious Diseases Department in Sousse – Tunisia between 2000 and 2013. They were 4 males and one female, mean age 60 years. Three patients were diabetic and one patient had acute leukemia. The locations of mucormycosis were rhinocerebral, rhino-orbital, auricular, pulmonary and cutaneous. The Mucorales isolated were Rhizopus arrhizus in 3 cases and Lichteimia in 2 cases. All patients were treated with amphotericin B and 2 patients had, in addition, surgical debridement. Two patients died and 2 kept peripheral facial paralysis. PMID:26137308

  19. The quiet revolution: reporting of health outcomes in general medical journals.

    PubMed

    Seymour, J; Newell, D; Shiell, A

    1997-01-01

    This study reviews the extent of evaluation of health outcomes in three general medical journals over the past decade by examining papers published in the original research section of the New England Journal of Medicine (NEJM), The Lancet, and the Medical Journal of Australia (MJA) in 1982 and 1992. Evaluations were identified and classified according to the type of comparison group and the type of outcome measures employed. They were divided into three categories: those employing a comparison group; those employing a before-and-after study design (or own comparison group); and those with no comparison group. The categories of outcome measures were mortality, clinical or intermediate measures of health state, and final outcome measures (quality of life). Results show that the proportion of papers evaluating a health services intervention remained stable over the period. However, the MJA published considerably fewer evaluations than the other journals. In the NEJM and The Lancet, 75 per cent of evaluations incorporated comparison groups, in the MJA, less than 40 per cent. Overall, the proportion of papers reporting final outcome measures increased significantly between 1982 and 1992 (p = 0.04) but the change in each journal individually did not reach statistical significance. This study indicates that the reporting of health outcomes evaluations has remained constant but there has been some change in the use of comparison groups and final outcome measures over time. PMID:10165947

  20. Patient- and person-reports on healthcare: preferences, outcomes, experiences, and satisfaction - an essay.

    PubMed

    Klose, K; Kreimeier, S; Tangermann, U; Aumann, I; Damm, K

    2016-12-01

    With the shift towards patient-centered healthcare, patient- and person-reports of health-related factors, including outcomes, are seen as important determinants for evaluating and improving healthcare. However, a comprehensive, systematic categorization of patient- and person-reports is currently lacking in the literature. This study aims at developing a new classification system with well-defined constructs for patients' and persons' self-reports on health and healthcare. A literature research and evaluation by the Reported Health Outcomes (RHO) Group were used to develop this classification system. The new classification system includes patient- and person-reported preferences, outcomes, experiences, and satisfaction related to healthcare and health outcomes. Moreover, the most constitutive methods to measure these four categories - preferences, outcomes, experiences, and satisfaction - have been described in this article. Even though the value of patients' and persons' perspectives on healthcare is increasingly being recognized, its measurement and implementation presents a lasting challenge to researchers, clinicians, patients, and the general population.

  1. Therapist-reported alliance: is it really a predictor of outcome?

    PubMed Central

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

    2015-01-01

    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 one 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. PMID:26323043

  2. 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

  3. 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.

  4. 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.

  5. 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…

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

    PubMed

    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

  7. 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

  8. The Educational Context and Outcomes for High School Students with Disabilities: The Perceptions of General Education Teachers. Research Report.

    ERIC Educational Resources Information Center

    Bulgren, Janis A.; Lenz, B. Keith; McKnight, Melinda; Davis, Betsy; Grossen, Bonnie; Marquis, Janet; Deshler, Donald D.; Schumaker, Jean B.

    The seventh in a series of studies investigating the educational context and outcomes for high school students with disabilities (SWDs), this study examined the high school context within which students with and without disabilities must succeed and the supports in place for assisting them. A questionnaire was administered to 70 high school…

  9. 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.

  10. 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

  11. Adverse Symptom Event Reporting by Patients vs Clinicians: Relationships With Clinical Outcomes

    PubMed Central

    Jia, Xiaoyu; Heller, Glenn; Barz, Allison; Sit, Laura; Fruscione, Michael; Appawu, Mark; Iasonos, Alexia; Atkinson, Thomas; Goldfarb, Shari; Culkin, Ann; Kris, Mark G.; Schrag, Deborah

    2009-01-01

    Background In cancer treatment trials, the standard source of adverse symptom data is clinician reporting by use of items from the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE). Patient self-reporting has been proposed as an additional data source, but the implications of such a shift are not understood. Methods Patients with lung cancer receiving chemotherapy and their clinicians independently reported six CTCAE symptoms and Karnofsky Performance Status longitudinally at sequential office visits. To compare how patient's vs clinician's reports relate to sentinel clinical events, a time-dependent Cox regression model was used to measure associations between reaching particular CTCAE grade severity thresholds with the risk of death and emergency room visits. To measure concordance of CTCAE reports with indices of daily health status, Kendall tau rank correlation coefficients were calculated for each symptom with EuroQoL EQ-5D questionnaire and global question scores. Statistical tests were two-sided. Results A total of 163 patients were enrolled for an average of 12 months (range = 1–28 months), with a mean of 11 visits and 67 (41%) deaths. CTCAE reports were submitted by clinicians at 95% of visits and by patients at 80% of visits. Patients generally reported symptoms earlier and more frequently than clinicians. Statistically significant associations with death and emergency room admissions were seen for clinician reports of fatigue (P < .001), nausea (P = .01), constipation (P = .038), and Karnofsky Performance Status (P < .001) but not for patient reports of these items. Higher concordance with EuroQoL EQ-5D questionnaire and global question scores was observed for patient-reported symptoms than for clinician-reported symptoms. Conclusions Longitudinally collected clinician CTCAE assessments better predict unfavorable clinical events, whereas patient reports better reflect daily health status. These perspectives are

  12. Comparison of victims' reports and court records of intimate partner violence perpetrators' criminal case outcomes.

    PubMed

    Bell, Margret E; Larsen, Sadie E; Goodman, Lisa A; Dutton, Mary Ann

    2013-09-01

    Intimate partner violence (IPV) victims often report feeling confused and uninformed about court proceedings, including even about the final disposition of the case against their partner. This is problematic because victims' decisions in responding to subsequent abuse may be significantly influenced by their beliefs about the outcomes of prior court experiences. Also, researchers often rely on victim report of court case outcomes; discrepancies between women's reports and official records may account for some of the conflicting findings in the empirical literature. In the current study, we compared the reports of case outcome given by 81 women recruited immediately after the final hearing of an IPV-related criminal case against their perpetrator with court records of case outcome. Findings revealed a fair level of agreement between women's reports and court files that was significantly different from the level of agreement expected by chance, but far from perfect. Level of agreement increased substantially when cases involving suspended sentences were removed. In reviewing these findings, we discuss the extent to which results can or cannot be interpreted as reflecting the accuracy of women's knowledge and review their implications for IPV researchers and court systems.

  13. 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

  14. Progress Report on Student Learning Outcomes Assessment. A Report to the Maryland Higher Education Commission from Howard Community College.

    ERIC Educational Resources Information Center

    Howard Community Coll., Columbia, MD. Office of Planning and Evaluation.

    Illustrates progress made at Howard Community College (HCC) in the last three years in efforts to improve student learning, instructional effectiveness, and curriculum. Information for this progress report was compiled with input from offices involved in monitoring outcomes assessment of student learning at the college. These include the office of…

  15. Poor patient-reported outcome after hip replacement, related to poor perception of perioperative information, commoner in immigrants than in non-immigrants.

    PubMed

    Krupic, Ferid; Rolfson, Ola; Nemes, Szilard; Kärrholm, Johan

    2016-06-01

    Background and purpose - In preparing patients for total hip replacement surgery, providing thorough information helps to reduce anxiety, manage postoperative pain, prevent complications, and better engage patients in their rehabilitation. However, patient characteristics may have an influence on the ability to comprehend and assimilate the information given. We investigated differences in patients born in Sweden and those born outside Sweden regarding how they perceived the information given before THR, and if this was associated with different patient-reported outcomes one year after surgery. Patients and methods - From Sahlgrenska University Hospital, we recruited 150 patients born in Sweden and 50 patients born outside Sweden who were to undergo THR. We retrieved routinely collected data from the Swedish Hip Arthroplasty Register including basic demographic variables and patient-reported outcome measures, both preoperatively and at 1-year follow-up. In a separate survey carried out 1-2 weeks after surgery, patients were asked about the information provided in connection with the operation. Results - Patients born outside Sweden more frequently reported that they were poorly informed about possibilities to treat pain and about the operation itself. 1 year after the operation, patients born outside Sweden who, 1-2 weeks after the operation, had reported that they were poorly informed also reported having worse outcomes. Poorer results were found for the questions self-care and anxiety/depression in the EQ-5D questionnaire, pain on a visual analog scale (VAS), EQVAS, and EQ-5D index compared to those patients born in Sweden who had received at least some information of acceptable quality. Interpretation - One quarter of the patients were not satisfied with the information provided before and after THR. These patients more commonly reported perioperative anxiety and they were more often born outside Sweden. Poorly informed patients who had come from countries

  16. Poor patient-reported outcome after hip replacement, related to poor perception of perioperative information, commoner in immigrants than in non-immigrants

    PubMed Central

    Krupic, Ferid; Rolfson, Ola; Nemes, Szilard; Kärrholm, Johan

    2016-01-01

    Background and purpose In preparing patients for total hip replacement surgery, providing thorough information helps to reduce anxiety, manage postoperative pain, prevent complications, and better engage patients in their rehabilitation. However, patient characteristics may have an influence on the ability to comprehend and assimilate the information given. We investigated differences in patients born in Sweden and those born outside Sweden regarding how they perceived the information given before THR, and if this was associated with different patient-reported outcomes one year after surgery. Patients and methods From Sahlgrenska University Hospital, we recruited 150 patients born in Sweden and 50 patients born outside Sweden who were to undergo THR. We retrieved routinely collected data from the Swedish Hip Arthroplasty Register including basic demographic variables and patient-reported outcome measures, both preoperatively and at 1-year follow-up. In a separate survey carried out 1–2 weeks after surgery, patients were asked about the information provided in connection with the operation. Results Patients born outside Sweden more frequently reported that they were poorly informed about possibilities to treat pain and about the operation itself. 1 year after the operation, patients born outside Sweden who, 1–2 weeks after the operation, had reported that they were poorly informed also reported having worse outcomes. Poorer results were found for the questions self-care and anxiety/depression in the EQ-5D questionnaire, pain on a visual analog scale (VAS), EQVAS, and EQ-5D index compared to those patients born in Sweden who had received at least some information of acceptable quality. Interpretation One quarter of the patients were not satisfied with the information provided before and after THR. These patients more commonly reported perioperative anxiety and they were more often born outside Sweden. Poorly informed patients who had come from countries outside

  17. 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.

  18. 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.

  19. 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. PMID:19695006

  20. Relationships between the Food Expectancy Questionnaire (FEQ) and the Food Frequency Questionnaire (FFQ).

    PubMed

    Reid, Marie; Bunting, Jane; Hammersley, Richard

    2005-10-01

    The outcome expectancies of 250 respondents were examined using the Food Expectancy Questionnaire (FEQ), comparing expectancies about four different foods: fruit, vegetables, chocolate and sweets and plain biscuits. These expectancies were related to diet as assessed by a Food Frequency Questionnaire. As with alcohol expectancies [Jones, B. T., Corbin, W. & Fromme, K. (2001). A review of expectancy theory and alcohol consumption. Addiction, 96, 57-72], on which this research was modelled, positive and negative outcomes were the main factors for all foods, accounting jointly for between 33 and 40% of expectancy variance in factor analysis and predicting as much as 16% of the variance in relevant food intake measures by linear regression. Expected positive and negative outcomes of eating were predominantly immediate psychological after-effects, rather than including orosensory experiences, or longer-term effects on health or well-being. Other expectancies varied from food to food. FEQ expectancies for different foods have similar factor structure and were related to self-reported diet, the FEQ therefore shows promise as a means of modelling cognitions about eating.

  1. Relationships between the Food Expectancy Questionnaire (FEQ) and the Food Frequency Questionnaire (FFQ).

    PubMed

    Reid, Marie; Bunting, Jane; Hammersley, Richard

    2005-10-01

    The outcome expectancies of 250 respondents were examined using the Food Expectancy Questionnaire (FEQ), comparing expectancies about four different foods: fruit, vegetables, chocolate and sweets and plain biscuits. These expectancies were related to diet as assessed by a Food Frequency Questionnaire. As with alcohol expectancies [Jones, B. T., Corbin, W. & Fromme, K. (2001). A review of expectancy theory and alcohol consumption. Addiction, 96, 57-72], on which this research was modelled, positive and negative outcomes were the main factors for all foods, accounting jointly for between 33 and 40% of expectancy variance in factor analysis and predicting as much as 16% of the variance in relevant food intake measures by linear regression. Expected positive and negative outcomes of eating were predominantly immediate psychological after-effects, rather than including orosensory experiences, or longer-term effects on health or well-being. Other expectancies varied from food to food. FEQ expectancies for different foods have similar factor structure and were related to self-reported diet, the FEQ therefore shows promise as a means of modelling cognitions about eating. PMID:15949872

  2. Use of patient-reported outcomes to measure symptoms and health related quality of life in the clinic.

    PubMed

    Gilbert, Alexandra; Sebag-Montefiore, David; Davidson, Susan; Velikova, Galina

    2015-03-01

    There is increasing interest in the use of patient-reported outcomes (PROs) in routine practice in cancer care to measure symptoms and health related quality of life (HRQOL). PROs are designed to capture the patient's perspective of their care and treatment, and complement the traditional clinical outcomes of survival and toxicity assessment. Integrating routine collection and feedback of PROs has been found to improve care for patients on both an individual level, through improved communication and management of symptoms, and at an organizational level, by enabling aggregation of data to compare performance. This article reviews the benefits and challenges of introducing patient-reported assessments into routine clinical practice. Methods for choosing a questionnaire; collection and presentation of results; timing and frequency of administration as well as clinician training methods to aid the ability of clinicians to integrate the use of PROs into their own practice are described. Electronic PRO capture and integration with electronic health records seems to provide the most effective method for seamless integration into existing patient care pathways. Case studies from our own practice illustrate the issues raised. Electronic methods enabling immediate collection, scoring and interpretation of the data, as well as real-time data capture, email alert systems and individualized, online self-management advice may enable severe symptoms to be managed in a more timely manner. Evaluation methods are described to establish the effectiveness of the PRO intervention. Engaging stakeholders throughout the process of initial consultation and development, during delivery and evaluation is key to success. Future work needs to focus on the effectiveness of PROs in longer-term follow-up of patients in routine care and the relationship between the PRO severity grading and clinician severity grading using the Common Terminology Criteria of Adverse Events (CTCAE). PMID:25448486

  3. 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.

  4. 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.…

  5. 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…

  6. 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…

  7. Selection of General Growth Outcomes for Children between Birth and Age Eight. Technical Report #2.

    ERIC Educational Resources Information Center

    McConnell, Scott; McEvoy, Mary; Carta, Judith J.; Greenwood, Charles R.; Kaminski, Ruth; Good, Roland H., III; Shinn, Mark; Ysseldyke, James; Goldberg, Paula

    This document reports on development of a comprehensive system for measuring the ongoing development of children with disabilities from birth to age 8. A multi-step process was used to identify a set of general growth outcomes for children in this age range and to begin formulating individualized indicators of growth and development, as well as…

  8. College Performance of New Maryland High School Graduates. Student Outcome and Achievement Report (SOAR)

    ERIC Educational Resources Information Center

    Maryland Higher Education Commission, 2009

    2009-01-01

    The 2009 SOAR (Student Outcome and Achievement Report) relies upon two sets of data, the academic performance data (which are collected directly from the colleges and universities) and the SAT (Scholastic Assessment Test)/ACT (American College Testing Program) data, to examine the relationship between students' academic achievements and…

  9. Rose-colored answers: Neuropsychological deficits and patient-reported outcomes after stroke

    PubMed Central

    Barrett, Anna M.

    2010-01-01

    Patient-reported, subjective outcomes are promoted as a standard for ethical, valid studies in many neurological disorders. Such outcomes are considered potentially more sensitive and specific to important therapeutic effects, and may be more linked to disability and disease-related life losses than conventional assessments of impairment (e.g. ability to walk, performance on language tests, serological or radiological indices). Self-report is invaluable to identify social and emotional consequences of brain injury: depression, changes in intimate and family relationships, social role and community participation losses. However, common stroke-related neuropsychological deficits are likely to confound subjective stroke outcome measures. The scientific community focused on stroke-related health outcomes may arrive at significantly underestimated patient reports of stroke-related disability, caused by a failure to adjust for the effect on self-report of spatial neglect, deficits of magnitude estimation, pathologic alteration of self-awareness, and alteration in distributed cortical systems supporting emotional semantics and abstraction. PMID:20543455

  10. Integrating cancer survivors' experiences into UK cancer registries: design and development of the ePOCS system (electronic Patient-reported Outcomes from Cancer Survivors)

    PubMed Central

    Ashley, L; Jones, H; Thomas, J; Forman, D; Newsham, A; Morris, E; Johnson, O; Velikova, G; Wright, P

    2011-01-01

    Background: Understanding the psychosocial challenges of cancer survivorship, and identifying which patients experience ongoing difficulties, is a key priority. The ePOCS (electronic patient-reported outcomes from cancer survivors) project aims to develop and evaluate a cost-efficient, UK-scalable electronic system for collecting patient-reported outcome measures (PROMs), at regular post-diagnostic timepoints, and linking these with clinical data in cancer registries. Methods: A multidisciplinary team developed the system using agile methods. Design entailed process mapping the system's constituent parts, data flows and involved human activities, and undertaking usability testing. Informatics specialists built new technical components, including a web-based questionnaire tool and tracking database, and established component-connecting data flows. Development challenges were overcome, including patient usability and data linkage and security. Results: We have developed a system in which PROMs are completed online, using a secure questionnaire administration tool, accessed via a public-facing website, and the responses are linked and stored with clinical registry data. Patient monitoring and communications are semiautomated via a tracker database, and patient correspondence is primarily Email-based. The system is currently honed for clinician-led hospital-based patient recruitment. Conclusions: A feasibility test study is underway. Although there are possible challenges to sustaining and scaling up ePOCS, the system has potential to support UK epidemiological PROMs collection and clinical data linkage. PMID:22048035

  11. Programmatic assessment of a university-based implant training program using patient-reported outcomes.

    PubMed

    Al-Sabbagh, Mohanad; Jenkins, Diane W; de Leeuw, Reny; Nihill, Patricia; Robinson, Fonda G; Thomas, Mark V

    2014-11-01

    The University of Kentucky College of Dentistry (UKCD) established an implant training program that provides training in the use of a single implant system, evidence-based diagnostic and treatment protocols (standardized work practices), and a total quality management system (Implant Quality Assurance Program). The aim of this study was to assess the programmatic effectiveness of the UKCD implant training program by reporting the success and survival of implants placed, using patient-reported outcomes and comparing them to previously established benchmarks. A total of 415 patients (963 implants) were interviewed, approximately 50 percent of all qualified patients. The implant survival rate was 97 percent, and 88 percent of the implants were considered successful (as determined by patient-centric criteria). These outcomes were consistent with the program's previously established benchmarks of 90 percent. These results suggest that work standardization (in the form of specific treatment protocols) and the use of a formal, incremental learning system can result in positive patient outcomes. Clinical outcomes should be monitored in academic dental settings as part of clinical process improvement, and these outcomes can provide a means of assessing the effectiveness of the training program.

  12. 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

  13. Assessment of smoking behaviour in the dental setting. A study comparing self-reported questionnaire data and exhaled carbon monoxide levels.

    PubMed

    Frei, Marc; Engel Brügger, Odette; Sendi, Pedram; Reichart, Peter A; Ramseier, Christoph A; Bornstein, Michael M

    2012-06-01

    The present study validated the accuracy of data from a self-reported questionnaire on smoking behaviour with the use of exhaled carbon monoxide (CO) level measurements in two groups of patients. Group 1 included patients referred to an oral medicine unit, whereas group 2 was recruited from the daily outpatient service. All patients filled in a standardized questionnaire regarding their current and former smoking habits. Additionally, exhaled CO levels were measured using a monitor. A total of 121 patients were included in group 1, and 116 patients were included in group 2. The mean value of exhaled CO was 7.6 ppm in the first group and 9.2 ppm in the second group. The mean CO values did not statistically significantly differ between the two groups. The two exhaled CO level measurements taken for each patient exhibited very good correlation (Spearman's coefficient of 0.9857). Smokers had a mean difference of exhaled CO values of 13.95 ppm (p < 0.001) compared to non-smokers adjusted for the first or second group. The consumption of one additional pack year resulted in an increase in CO values of 0.16 ppm (p = 0.003). The consumption of one additional cigarette per day elevated the CO measurements by 0.88 ppm (p < 0.001). Based on these results, the correlations between the self-reported smoking habits and exhaled CO values are robust and highly reproducible. CO monitors may offer a non-invasive method to objectively assess current smoking behaviour and to monitor tobacco use cessation attempts in the dental setting.

  14. Quality of outcome reporting in phase II studies in pulmonary tuberculosis.

    PubMed

    Bonnett, Laura Jayne; Davies, Geraint Rhys

    2015-01-01

    Tuberculosis (TB) remains a major killer amongst the infectious diseases. Current treatment involves a four-drug regimen for at least 6 months. New drugs and regimens are required to shorten treatment duration, reduce toxicity and combat drug resistance, but the optimal methodology to define the critical path for novel regimens is not well defined. We undertook a systematic review to summarise outcomes reported in Phase II trials of patients with newly diagnosed pulmonary TB to assess the need for a core outcome set. A systematic search of databases (PubMed, MEDLINE, EMBASE and LILACs) was conducted on 1 May 2015 to retrieve relevant peer-reviewed articles. Reference lists of included studies were also searched. This systematic review considered all reported outcomes. Risk of bias was considered via sequence generation, allocation concealment, blinding, reasons for exclusions, and selective reporting. Of 55 included studies, 20 were Phase IIB studies based on culture conversion, 32 were Phase IIA studies based on quantitative bacteriology, and three considered alternative outcomes. Large variation in reported outcomes and trial characteristics was observed across the included studies. Bacteriological results were as often expressed in terms of positivity as negativity, with varying definitions of culture conversion. Variation in reporting was particularly marked for Phase IIA studies, where multiple time intervals were typically selected for analysis and sometimes resulted in differing interpretations of the efficacy of drugs or regimens. Within both Phase IIA and IIB studies, there was variation in the time points at which the study participants were sampled, as well as in the bacteriological media and methods used. For successful future meta-analysis of early-phase studies, the findings of this review suggest that development of a core outcome set would be desirable. This would enable trial results to be more easily compared and combined, potentially leading to

  15. The Alcoholism Questionnaire.

    ERIC Educational Resources Information Center

    Ferneau, E.; Mueller, S.

    The alcoholism questionnaire used to survey college student attitudes on the subject is provided. It is identical to the drug-abuse questionnaire except for word changes appropriate to the subject matter. The questionnaire consists of 40 statements about alcoholics and alcoholism, with 7 possible responses: (1) completely disagree; (2) mostly…

  16. 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.

  17. 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. PMID:26573174

  18. Study design for non-recurring, time-to-event outcomes in the presence of error-prone diagnostic tests or self-reports.

    PubMed

    Gu, Xiangdong; Balasubramanian, Raji

    2016-09-30

    Sequentially administered, laboratory-based diagnostic tests or self-reported questionnaires are often used to determine the occurrence of a silent event. In this paper, we consider issues relevant in design of studies aimed at estimating the association of one or more covariates with a non-recurring, time-to-event outcome that is observed using a repeatedly administered, error-prone diagnostic procedure. The problem is motivated by the Women's Health Initiative, in which diabetes incidence among the approximately 160,000 women is obtained from annually collected self-reported data. For settings of imperfect diagnostic tests or self-reports with known sensitivity and specificity, we evaluate the effects of various factors on resulting power and sample size calculations and compare the relative efficiency of different study designs. The methods illustrated in this paper are readily implemented using our freely available R software package icensmis, which is available at the Comprehensive R Archive Network website. An important special case is that when diagnostic procedures are perfect, they result in interval-censored, time-to-event outcomes. The proposed methods are applicable for the design of studies in which a time-to-event outcome is interval censored. Copyright © 2016 John Wiley & Sons, Ltd. PMID:27189174

  19. Relationship between clinical and patient-reported outcomes in a phase 3 trial of tofacitinib or MTX in MTX-naïve patients with rheumatoid arthritis

    PubMed Central

    Fleischmann, Roy; Strand, Vibeke; Wilkinson, Bethanie; Kwok, Kenneth; Bananis, Eustratios

    2016-01-01

    Objective To compare the relationship between clinical measures and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) treated with tofacitinib or methotrexate (MTX). Methods In a phase 3 randomised controlled trial, patients (N=956) who were MTX-naïve or had received ≤3 doses were randomised and received tofacitinib 5 or 10 mg twice daily or MTX titrated to 20 mg/week. Outcomes included: per cent of patients achieving American College of Rheumatology 70% responses (ACR70), ACR50, low disease activity (LDA) by Simplified Disease Activity Index (SDAI ≤11) and Clinical Disease Activity Index (CDAI ≤10), remission by SDAI (≤3.3) and CDAI (≤2.8), patient-reported Health Assessment Questionnaire-Disability Index (HAQ-DI scores <0.5), pain and global assessment of disease activity. Results At month 6, most patients who achieved LDA/remission by one definition achieved LDA/remission with others; however, discordance between measures was greater with MTX than with tofacitinib. As expected, concordance between CDAI and SDAI responses was high. Overall, patients achieving LDA or ACR50 responses reported less improvement in PROs (HAQ-DI, pain and patient global assessment) compared with clinical measures (tender and swollen joint counts). Conclusions Variability in levels of responses between clinical outcomes and PROs should be considered when setting treat-to-target goals in patients with RA. Trial registration number NCT01039688; Post-results. PMID:27175296

  20. Gender differences in self reported long term outcomes following moderate to severe traumatic brain injury

    PubMed Central

    2010-01-01

    Background The majority of research on health outcomes after a traumatic brain injury is focused on male participants. Information examining gender differences in health outcomes post traumatic brain injury is limited. The purpose of this study was to investigate gender differences in symptoms reported after a traumatic brain injury and to examine the degree to which these symptoms are problematic in daily functioning. Methods This is a secondary data analysis of a retrospective cohort study of 306 individuals who sustained a moderate to severe traumatic brain injury 8 to 24 years ago. Data were collected using the Problem Checklist (PCL) from the Head Injury Family Interview (HIFI). Using Bonferroni correction, group differences between women and men were explored using Chi-square and Wilcoxon analysis. Results Chi-square analysis by gender revealed that significantly more men reported difficulty setting realistic goals and restlessness whereas significantly more women reported headaches, dizziness and loss of confidence. Wilcoxon analysis by gender revealed that men reported sensitivity to noise and sleep disturbances as significantly more problematic than women, whereas for women, lack of initiative and needing supervision were significantly more problematic in daily functioning. Conclusion This study provides insight into gender differences on outcomes after traumatic brain injury. There are significant differences between problems reported by men compared to women. This insight may facilitate health service planners and clinicians when developing programs for individuals with brain injury. PMID:21029463

  1. 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

  2. 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

  3. Epidemiology and Outcome of Trichosporon Fungemia: A Review of 185 Reported Cases From 1975 to 2014.

    PubMed

    Liao, Yong; Lu, Xuelian; Yang, Suteng; Luo, Yi; Chen, Qi; Yang, Rongya

    2015-12-01

    Background.  Trichosporon species have emerged as an important non-Candida spp yeast pathogen in immunocompromised patients in recent decades; however, the systemic analysis of Trichosporon epidemiology has seldom been reported. Methods.  We reviewed 185 reported cases of Trichosporon fungemia from 1975 to 2014 in the English-language literature, and the epidemiology and prognostic factors of the included cases are described. Results.  The number of cases reported has increased with time, especially over the past decade. During the 3 decades from 1975 to 2004, the most commonly used antifungal compounds were amphotericin B/liposomal amphotericin B; however, in recent decades (2005-2014), triazoles (especially voriconazole) have become the most widely used agents, significantly improving outcome in the reported cases. Correlation analysis revealed that negative outcome is associated with several prognostic factors, including a history of antimicrobial use, bacterial bloodstream coinfection, prophylactic/empirical antifungal therapy, Trichosporon beigelii infection, and receiving the antifungal regimen of amphotericin B/liposomal amphotericin B. In addition, a significantly greater proportion of patients with a positive outcome had fungemia without invasive tissue infection and received a voriconazole regimen or an AmB-triazole combined regimen. Significant positive outcome was also associated with patients who had recovered from neutropenia or after central venous catheter removal. Conclusions.  Voriconazole can be recommended as a first-line antifungal compound to treat Trichosporon fungemia; the immune status of the host plays a crucial role in the outcome of this infection, and the removal of vascular catheters should be considered if feasible. PMID:26566536

  4. Patient-Reported Outcome Assessments as Endpoints in Studies in Infectious Diseases.

    PubMed

    Powers, John H; Howard, Kellee; Saretsky, Todd; Clifford, Sarah; Hoffmann, Steve; Llorens, Lily; Talbot, George

    2016-08-15

    The goal of administering medical interventions is to help patients live longer or live better. In keeping with this goal, there has been increasing interest in taking the "voice" of the patient into account during the development process, specifically in the evaluation of treatment benefits of medical interventions, and use of patient-centered outcome data to justify reimbursement. Patient-reported outcomes (PROs) are outcome assessments (OAs) used to define endpoints that can provide direct evidence of treatment benefit on how patients feel or function. When PROs are appropriately developed, they can increase the efficiency and clinical relevance of clinical trials. Several PROs have been developed for OA in specific infectious diseases indications, and more are under development. PROs also hold promise for use in evaluating adherence, adverse effects, satisfaction with care, and routine clinical practice. PMID:27481954

  5. Childhood predictors and age 48 outcomes of self-reports and official records of offending

    PubMed Central

    DUBOW, ERIC F.; HUESMANN, L. ROWELL; BOXER, PAUL; SMITH, CATHY

    2014-01-01

    Background The key question is: are self-reports and official records equally valid indicators of criminal offending? Aims We examine the correspondence between self-reports and official records of offending, the similarity of childhood and adolescent individual and contextual predictors of both measures of offending, and the similarity of age 48 correlates of both measures of offending. Methods Men (N = 436) from the Columbia County Longitudinal Study, a sample of all 3rd graders in Columbia County, New York, in 1959–60, participated. The youth, their peers and their parents were interviewed when the youth were age 8; the youth were later interviewed at ages 19, 30 and 48. Results We found moderate to high correspondence between self-reports of having been in trouble with the law and official arrest records. Lifetime self-reports and official records of offending were generally predicted by the same childhood and adolescent variables, and were correlated with many of the same adult outcome measures. By age 48, life-course non-offenders defined by either self-reports or official records had better outcomes than offenders. Conclusions The results validate the use of adolescent and adult self-reports of offending, and the early identification of individuals at risk for adult criminal behaviour through childhood parent and peer reports and adolescent self and peer reports. PMID:25294162

  6. Systematic review of measurement properties of patient-reported outcome measures used in patients undergoing hip and knee arthroplasty

    PubMed Central

    Harris, Kristina; Dawson, Jill; Gibbons, Elizabeth; Lim, Chris R; Beard, David J; Fitzpatrick, Raymond; Price, Andrew J

    2016-01-01

    Objectives To identify patient-reported outcome measures (PROMs) that have been developed and/or used with patients undergoing hip or knee replacement surgery and to provide a shortlist of the most promising generic and condition-specific instruments. Methods A systematic review of the literature was performed to identify measures used in patients undergoing hip and knee replacement and extract and evaluate information on their methodological quality. Results Thirty-two shortlisted measures were reviewed for the quality of their measurement properties. On the basis of the review criteria, the measures with most complete evidence to date are the Oxford Hip Score (OHS) (for patients undergoing hip replacement surgery) and the Oxford Knee Score (OKS), with OKS-Activity and Participation Questionnaire (for patients undergoing knee replacement surgery). Conclusion A large number of these instruments lack essential evidence of their measurement properties (eg, validity, reliability, and responsiveness) in specific populations of patients. Further research is required on almost all of the identified measures. The best-performing condition-specific PROMs were the OKS, OHS, and Western Ontario and McMaster Universities Osteoarthritis Index. The best-performing generic measure was the Short Form 12. Researchers can use the information presented in this review to inform further psychometric studies of the reviewed measures. PMID:27524925

  7. 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

  8. 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.

  9. Is the use of antidepressants associated with patient-reported outcomes following total hip replacement surgery?

    PubMed

    Greene, Meridith E; Rolfson, Ola; Gordon, Max; Annerbrink, Kristina; Malchau, Henrik; Garellick, Göran

    2016-10-01

    Background and purpose - Patients with anxiety and/or depression tend to report less pain reduction and less satisfaction with surgical treatment. We hypothesized that the use of antidepressants would be correlated to patient-reported outcomes (PROs) 1 year after total hip replacement (THR), where increased dosage or discontinuation would be associated with worse outcomes. Patients and methods - THR cases with pre- and postoperative patient-reported outcome measures (PROMs) were selected from the Swedish Hip Arthroplasty Register (n = 9,092; women: n = 5,106). The PROMs were EQ-5D, visual analog scale (VAS) for pain, Charnley class, and VAS for satisfaction after surgery. These cases were merged with a national database of prescription purchases to determine the prevalence of antidepressant purchases. Regression analyses were performed where PROs were dependent variables and sex, age, Charnley class, preoperative pain, preoperative health-related quality of life (HRQoL), patient-reported anxiety/depression, and antidepressant use were independent variables. Results - Antidepressants were used by 10% of the cases (n = 943). Patients using antidepressants had poorer HRQoL and higher levels of pain before and after surgery and they experienced less satisfaction. Preoperative antidepressant use was independently associated with PROs 1 year after THR regardless of patient-reported anxiety/depression. Interpretation - Antidepressant usage before surgery was associated with reduced PROs after THR. Cases at risk of poorer outcomes may be identified through review of the patient's medical record. Clinicians are encouraged to screen for antidepressant use preoperatively, because their use may be associated with PROs after THR. PMID:27482877

  10. 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. PMID:27384740

  11. 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. PMID:26873745

  12. 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.

  13. Self-report of illicit benzodiazepine use on the Addiction Severity Index predicts treatment outcome

    PubMed Central

    Ghitza, Udi E.; Epstein, David H.; Preston, Kenzie L.

    2008-01-01

    The relationship between pretreatment illicit benzodiazepine use (days of use in the last 30) assessed on the Addiction Severity Index (ASI) and treatment outcome was investigated by retrospective analysis of data from two controlled clinical trials in 361 methadone maintained cocaine/opiate users randomly assigned to 12-week voucher- or prize-based contingency management (CM) or control interventions. Based on screening ASI, participants were identified as nonusers (BZD-N; 0 days of use) or users (BZD-U; >0 days of use). Outcome measures were: urine drug screens (thrice weekly); quality of life and self-reported HIV-risk behaviors (every 2 weeks); and current DSM-IV diagnosis of cocaine and heroin dependence (study exit). In the CM group, BZD-U had significantly worse outcomes on in-treatment cocaine use, quality-of-life scores, needle-sharing behaviors, and current heroin dependence diagnoses at study exit compared to BZD-N. In the control group, BZD-U had significantly higher in-treatment cocaine use but did not differ from BZD-N on psychosocial measures. Thus, in a sample of non-dependent BZD users, self-reported illicit BZD use on the ASI, even at low levels, predicted worse outcome on cocaine use and blunted response to CM. PMID:18499354

  14. 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.

  15. 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

  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. 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

  18. 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

  19. The development of a congenital heart programme quality dashboard to promote transparent reporting of outcomes.

    PubMed

    Anand, Vijay; Cave, Dominic; McCrady, Heather; Al-Aklabi, Mohammed; Ross, David B; Rebeyka, Ivan M; Adatia, Ian

    2015-12-01

    In 2001, the Institute of Medicine identified healthcare transparency as a necessity for re-designing a quality healthcare system; however, despite widespread calls for publicly available transparent data, the goal remains elusive. The transparent reporting of outcome data and the results of congenital heart surgery is critical to inform patients and families who have both the wish and the ability to choose where care is provided. Indeed, in an era where data and means of communication of data have never been easier, the paucity of transparent data reporting is paradoxical. We describe the development of a quality dashboard used to inform staff, patients, and families about the outcomes of congenital heart surgery at the Stollery Children's Hospital. PMID:26675607

  20. 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

  1. Surgical treatment achieves better outcome in severe traumatic pericallosal aneurysm: case report and literature review

    PubMed Central

    Sui, Mingxing; Mei, Qiyong; Sun, Kehua

    2015-01-01

    Traumatic pericallosal aneurysm (TPA) is typically seldom yet potentially lethal. Because of its rarity, also complicated by the unpredictable delayed-onset, TPA is more difficult to be diagnosed promptly. Due to the sporadic reports and diverse opinions on the priority of surgical treatment, a consensus about effective management of TPA has not been reached. Here we report a 55 year-old male patient with TPA, who received an emergent craniotomy to clip the pseudoaneurysm and remove the hematoma under intense intracranial pressure (ICP) monitoring. A satisfactory clinical outcome was achieved at a 3-month follow-up. Thereafter, a review was conducted to evaluate the outcomes of different managing modalities. PMID:25932088

  2. International confederation for cleft lip and palate and related craniofacial anomalies task force report: holistic outcomes.

    PubMed

    Broder, Hillary L

    2014-11-01

    Objective : This paper describes the process and outcomes of the 2013 American Cleft Palate-Craniofacial Association task force on Holistic Outcomes. The goals and membership of the task force are presented. Methods : Using internet communication, the group introduced themselves, shared ideas and information related to holistic assessment and implementation of using a validated holistic measure, the Child Oral Health Impact Profile (COHIP) at participating international sites. Results : Data from the sites were analyzed using descriptive statistics. Administration of the COHIP was successful. It varied from self-completion as well as verbal presentation due to language differences and a function of the short time period to complete collection. Additionally qualitative comments were reported by the task force site directors. Conclusions : Future directions for holistic assessment and communication among task force members and sites were discussed at the Congress and are presented in this report.

  3. When to operate: online patient-reported outcome measures (PROMs) can help decide.

    PubMed

    Reeve, William John Edward; Williams, Daniel H

    2016-01-01

    We present a report on use of a web-based electronic patient-reported outcome measures (ePROMs) system to support decision-making for a patient with an osteoarthritic knee. After being placed on a waiting list for knee arthroplasty, the use of preoperative PROMs allowed the patient and surgical team to review ongoing disability, and, as a result, alter the management plan by deferring surgery. Ongoing clinical review and symptom management has been centred on ePROMs and has been tailored to the specific needs of the individual. PROMs data are increasingly becoming a necessary component of outcome measurement in many surgical areas. Often, these data are available to neither patient nor clinician in a way that prospectively allows meaningful management. This case highlights how ePROMs can directly influence patient care in real time. PMID:27090539

  4. Laparoscopic Management of Interstitial Pregnancy and Fertility Outcomes after Ipsilateral Salpingectomy – Three Case Reports

    PubMed Central

    Manea, Cristina; Pavlidou, Evangelia; Urias, Aline Andrey; Bouquet de la Jolinière, Jean; Dubuisson, Jean Bernard; Feki, Anis

    2014-01-01

    Background: Interstitial pregnancy after ipsilateral salpingectomy is a rare event with potentially serious consequences. Optimal management strategy remains uncertain and debated. In addition, fertility sparing is determinant of the treatment choice. Cases: Here, we report three cases of interstitial pregnancy occurring after homolateral salpingectomy. We expose the therapeutic option held in all three situations, which associated laparoscopic procedure followed by intramuscular methotrexate injection with successful outcome for all patients. We also report the fertility outcome for the first patient, discussing the timing and mode of delivery. Cesarean section at term was performed for this patient. Conclusion: In these three situations, we obtained a successful result using a minimally invasive surgical approach combined with systemic methotrexate injection. Cesarean section at term for subsequent intrauterine pregnancy seems to be the safest delivery strategy, although no clear data exist in literature. PMID:25593958

  5. 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

  6. Good visual outcome in an immunocompromised patient with bilateral acute retinal necrosis syndrome: A case report

    PubMed Central

    Marrocos de Aragão, Ricardo E.; Barreira, Ieda M.A.; Arrais, Barbara L.A.; Pereira, Leidiane A.; Ramos, Carine S.

    2013-01-01

    Acute retinal necrosis (ARN) is an uncommon necrotizing, fulminant retinopathy caused by the herpes simplex virus types 1 or 2 or by the varicella zoster vírus with visually devastating consequences. Generally it occurs in patients who are systemically healthy, but occasionally occurs in immunocompromised host. We report a case of bilateral ARN in a patient with AIDS with a good final visual outcome. PMID:25278806

  7. Physical Exam and Self-Reported Pain Outcomes from a Randomized Trial on Chronic Cervicogenic Headache

    PubMed Central

    Vavrek, Darcy; Haas, Mitchell; Peterson, Dave

    2010-01-01

    Objective Objective clinical measures for use as surrogate markers of cervicogenic headache (CGH) pain have not been established. In this analysis, we investigate relationships between objective physical exam (PE) measures with self-reported CGH outcomes. Methods This is an exploratory analysis of data generated by attention control PE from an open-label randomized clinical trial. Forty of 80 subjects were randomized to 8 treatments (spinal manipulative therapy or light massage control) and 8 PE over 8 weeks. The remaining subjects received no PE. PE included motion palpation of the cervical and upper thoracic regions, active cervical range of motion (ROM) and associated pain, and algometric pain threshold evaluated over articular pillars. Self-reported outcomes included CGH and neck pain and disability, number of CGH headaches, and related disability days. Associations between PE and self-reported outcomes were evaluated using generalized linear models, adjusting for socio-demographic differences and study group. Results At baseline, number of CGH and disability days were strongly associated with cervical active ROM (p <.001 to .037). Neck pain and disability were strongly associated with ROM-elicited pain (p <.001 to .035) but not later in the study. After the final treatment, pain thresholds were strongly associated with week 12 neck pain and disability and CGH disability and disability days (p =<.001 to .048). Conclusions Cervical ROM was most associated with the baseline headache experience. However, 4 weeks after treatment, algometric pain thresholds were most associated. No one PE measure remained associated with the self-reported headache outcomes over time. PMID:20605552

  8. 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

  9. 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

  10. Systematic review of patient-reported outcome measures (PROMs) for assessing disease activity in rheumatoid arthritis.

    PubMed

    Hendrikx, Jos; 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

  11. 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

  12. 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

  13. Development and preliminary psychometric evaluation of the parent report version of the Bath Adolescent Pain Questionnaire (BAPQ-P): A multidimensional parent report instrument to assess the impact of chronic pain on adolescents.

    PubMed

    Eccleston, Christopher; McCracken, Lance M; Jordan, Abbie; Sleed, Michelle

    2007-09-01

    Assessing the experience and impact of pain in adolescents with chronic pain is necessary to guide both individual treatment and to inform treatment development. Ideally, to obtain a comprehensive understanding of the impact of pain, assessment should be multidimensional, should be sensitive to contextual variables, and should allow for multiple informants (in particular, parents). The purpose of this study was to develop a standardized parent-report measure of chronic pain in adolescents, the Bath Adolescent Pain Questionnaire - Parent report (BAPQ-P). Participants included 222 adolescents with chronic pain and their parents recruited from two specialty clinics in the UK. The adolescents completed a battery of self-report inventories related to their pain and daily functioning whilst parents completed the BAPQ-P and additional measures of adolescent functioning. Scales of the BAPQ-P emerged to be internally consistent and temporally stable over a 17-day period. Validity was examined in relation to existing validated child report measures of anxiety, depression, catastrophizing, disability, family, and social functioning and parent report measures of disability and family functioning. Psychometric evaluation suggests that the BAPQ-P is a reliable and valid parental report tool for assessing the multidimensional impact of adolescent chronic pain. It can be used in conjunction with the previously established adolescent self-report measure, the BAPQ, alone where adolescent self report is not possible, in studies where parent report is the focus, or in studies where concordance between parent and adolescent reports is of interest.

  14. Patient-reported outcomes: pathways to better health, better services, and better societies.

    PubMed

    Black, N; Burke, L; Forrest, C B; Sieberer, U H Ravens; Ahmed, S; Valderas, J M; Bartlett, S J; Alonso, J

    2016-05-01

    While the use of PROs in research is well established, many challenges lie ahead as their use is extended to other applications. There is consensus that health outcome evaluations that include PROs along with clinician-reported outcomes and administrative data are necessary to inform clinical and policy decisions. The initiatives presented in this paper underline evolving recognition that PROs play a unique role in adding the patient perspective alongside clinical (e.g., blood pressure) and organizational (e.g., admission rates) indicators for evaluating the effects of new products, selecting treatments, evaluating quality of care, and monitoring the health of the population. In this paper, we first explore the use of PRO measures to support drug approval and labeling claims. We critically evaluate the evidence and challenges associated with using PRO measures to improve healthcare delivery at individual and population levels. We further discuss the challenges associated with selecting from the abundance of measures available, opportunities afforded by agreeing on common metrics for constructs of interest, and the importance of establishing an evidence base that supports integrating PRO measures across the healthcare system to improve outcomes. We conclude that the integration of PROs as a key end point within individual patient care, healthcare organization and program performance evaluations, and population surveillance will be essential for evaluating whether increased healthcare expenditure is translating into better health outcomes. PMID:26563251

  15. Application of patient-reported outcome measures (PROMs) data to estimate cost-effectiveness of hernia surgery in England

    PubMed Central

    Coronini-Cronberg, Sophie; Appleby, John; Thompson, James

    2013-01-01

    Objectives To demonstrate potential uses of nationally collected patient-reported outcome measures (PROMs) data to estimate cost-effectiveness of hernia surgery. Design Cost-utility model populated with national PROMs, National Reference Cost and Hospital Episodes Statistics data. Setting Hospitals in England that provided elective inguinal hernia repair surgery for NHS patients between 1 April 2009 and 31 March 2010. Participants Patients >18 years undergoing NHS-funded elective hernia surgery in English hospitals who completed PROMs questionnaires. Main outcome measures Change in quality-adjusted life year (QALY) following surgery; cost per QALY of surgery by acute provider hospital; health gain and cost per QALY by surgery type received (laparoscopic or open hernia repair). Results The casemix-adjusted, discounted (at 3.5%) and degraded (over 25 years) mean change in QALYs following elective hernia repair surgery is 0.826 (95% CI, 0.793–0.859) compared to a counterfactual of no treatment. Patients undergoing laparoscopic surgery show a significantly greater gain in health-related quality of life (EQ-5D index change, 0.0915; 95% CI, 0.0850–0.0979) with an estimated gain of 0.923 QALYS (95% CI, 0.859–0.988) compared to those having open repair (EQ-5D index change, 0.0806; 95% CI, 0.0771–0.0841) at 0.817 QALYS (95% CI, 0.782–0.852). The average cost of hernia surgery in England is £1554, representing a mean cost per QALY of £1881. The mean cost of laparoscopic and open hernia surgery is equivocal (£1421 vs. £1426 respectively) but laparoscopies appear to offer higher cost-utility at £1540 per QALY, compared to £1746 per QALY for open surgery. Conclusions Routine PROMs data derived from NHS patients could be usefully analyzed to estimate health outcomes and cost-effectiveness of interventions to inform decision-making. This analysis suggests elective hernia surgery offers value-for-money, and laparoscopic repair is more clinically effective and

  16. Questionnaire to assess relevance and credibility of modeling studies for informing health care decision making: an ISPOR-AMCP-NPC Good Practice Task Force report.

    PubMed

    Jaime Caro, J; Eddy, David M; Kan, Hong; Kaltz, Cheryl; Patel, Bimal; Eldessouki, Randa; Briggs, Andrew H

    2014-03-01

    The evaluation of the cost and health implications of agreeing to cover a new health technology is best accomplished using a model that mathematically combines inputs from various sources, together with assumptions about how these fit together and what might happen in reality. This need to make assumptions, the complexity of the resulting framework, the technical knowledge required, as well as funding by interested parties have led many decision makers to distrust the results of models. To assist stakeholders reviewing a model's report, questions pertaining to the credibility of a model were developed. Because credibility is insufficient, questions regarding relevance of the model results were also created. The questions are formulated such that they are readily answered and they are supplemented by helper questions that provide additional detail. Some responses indicate strongly that a model should not be used for decision making: these trigger a "fatal flaw" indicator. It is hoped that the use of this questionnaire, along with the three others in the series, will help disseminate what to look for in comparative effectiveness evidence, improve practices by researchers supplying these data, and ultimately facilitate their use by health care decision makers. PMID:24636375

  17. 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.

  18. 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…

  19. Questionnaire for Parents.

    ERIC Educational Resources Information Center

    Purdue Univ., Lafayette, IN. Educational Research Center.

    The 116-item parent questionnaire is designed for parents of elementary school children. It is intended to be used with the child's mother, or the person acting as the child's mother. The questionnaire consists of a section devoted to demographic variables and scales measuring 14 parent variables: (1) parent's achievement aspirations for the…

  20. 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)

  1. Methodological issues in measuring patient-reported outcomes: the agenda of the Work Group on Outcomes Assessment.

    PubMed

    Fowler, F J; Cleary, P D; Magaziner, J; Patrick, D L; Benjamin, K L

    1994-07-01

    The primary goal of the Inter-PORT work group on Outcomes Assessment is to foster methodological knowledge about the implications of various measure and design decisions for studies of the outcomes of treatment. A number of key methodological issues currently are unresolved and are in need of further study. These include: 1) the best questions to ask to assess how patients are affected by their treatments; 2) the comparative advantages of various study designs, including prospective cohorts, retrospective studies, and randomized clinical trials; 3) the way data collection decisions, such as mode of data collection and use of proxy respondents, affect study results; and 4) the best way to assess the significance of observed effects from patient, provider, and public policy perspectives. Studies conducted by the Patients Outcomes Research Teams (PORTs) are using diverse designs, measures, and data collection procedures. They provide a unique opportunity to further knowledge about methods of obtaining information about treatment outcomes. Through meetings, conferences, and publications, the Inter-PORT work group on Outcomes Assessment is trying to stimulate analyses aimed at methodological issues summarized in this paper and to ensure that new knowledge about methods is disseminated to a wide audience.

  2. 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

  3. 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

  4. Outcomes Definitions and Statistical Tests in Oncology Studies: A Systematic Review of the Reporting Consistency

    PubMed Central

    Rivoirard, Romain; Duplay, Vianney; Oriol, Mathieu; Tinquaut, Fabien; Chauvin, Franck; Magne, Nicolas; Bourmaud, Aurelie

    2016-01-01

    Background Quality of reporting for Randomized Clinical Trials (RCTs) in oncology was analyzed in several systematic reviews, but, in this setting, there is paucity of data for the outcomes definitions and consistency of reporting for statistical tests in RCTs and Observational Studies (OBS). The objective of this review was to describe those two reporting aspects, for OBS and RCTs in oncology. Methods From a list of 19 medical journals, three were retained for analysis, after a random selection: British Medical Journal (BMJ), Annals of Oncology (AoO) and British Journal of Cancer (BJC). All original articles published between March 2009 and March 2014 were screened. Only studies whose main outcome was accompanied by a corresponding statistical test were included in the analysis. Studies based on censored data were excluded. Primary outcome was to assess quality of reporting for description of primary outcome measure in RCTs and of variables of interest in OBS. A logistic regression was performed to identify covariates of studies potentially associated with concordance of tests between Methods and Results parts. Results 826 studies were included in the review, and 698 were OBS. Variables were described in Methods section for all OBS studies and primary endpoint was clearly detailed in Methods section for 109 RCTs (85.2%). 295 OBS (42.2%) and 43 RCTs (33.6%) had perfect agreement for reported statistical test between Methods and Results parts. In multivariable analysis, variable "number of included patients in study" was associated with test consistency: aOR (adjusted Odds Ratio) for third group compared to first group was equal to: aOR Grp3 = 0.52 [0.31–0.89] (P value = 0.009). Conclusion Variables in OBS and primary endpoint in RCTs are reported and described with a high frequency. However, statistical tests consistency between methods and Results sections of OBS is not always noted. Therefore, we encourage authors and peer reviewers to verify consistency of

  5. 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.

  6. Assessing severity of illness and outcomes of treatment in children with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME): a systematic review of patient-reported outcome measures (PROMs).

    PubMed

    Haywood, K L; Collin, S M; Crawley, E

    2014-11-01

    Chronic Fatigue Syndrome or Myalgic Encephalomyelitis (CFS/ME) in children is characterized by persistent or recurrent debilitating fatigue which results in a substantial reduction in activity. There is a growing interest in the use of questionnaires, or patient-reported outcome measures (PROMs), to assess how patients function and feel in relation to their health and associated healthcare. However, guidance for PROM selection for children with CFS/ME does not exist. We reviewed the quality and acceptability of PROMs used with children with CFS/ME to inform recommendations for practice. We conducted a systematic review of PROMs completed by children with CFS/ME. The quality of the evaluative studies and the reviewed measures were assessed against recommended criteria using an appraisal framework and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. We sought evidence of measurement (reliability, validity, responsiveness, interpretability, data quality) and practical properties (acceptability, relevance, feasibility). Sixteen articles were included in the review, providing evidence of reliability and/or validity for 13 PROMs. Of these, five were child-specific (one health-related quality-of-life; four emotional well-being) and eight were not (four emotional well-being, three fatigue-specific; and one generic). All measures had limited evidence of measurement properties and no evidence of practical properties. Recommendations for patient-reported assessment are difficult to make because of limited evidence of the quality and acceptability of PROMs for children with CFS/ME. The appraisal method highlighted significant methodological and quality issues which must be addressed in future research. There is a lack of qualitative evidence describing the outcomes of healthcare that are important to children with CFS/ME, and the relevance or appropriateness of available measures. Future PROM development and evaluation in

  7. Web-based patient-reported outcomes in drug safety and risk management: challenges and opportunities?

    PubMed

    Banerjee, Anjan K; Ingate, Simon

    2012-06-01

    Patient-reported outcomes (PROs) from web-based sources are becoming increasingly important, providing opportunities for industry and regulators to understand the benefits and risks of medicines in a real-world context. Although some guidance exists for the use of adverse event (AE) reports from company-sponsored social network sites, this does not cover non-company-sponsored sites. Additionally, there are concerns about the validity of data from social media sources. Techniques for the collection, analysis and reporting of safety data from patients should be defined, and guidelines agreed, to cover PROs and patient-reported adverse drug-related events from more organized sources of patient outcomes. This review considers drivers for web-based PRO adoption in drug safety, the current regulatory framework and potential methodologies, and concludes that there is an urgent unmet need for guidelines on web-based PRO AEs. Stakeholders for the development of any such guidance should include industry, patients, regulators, academic groups and prescribers. PMID:22551007

  8. Patient-reported outcomes measurement and management with innovative methodologies and technologies.

    PubMed

    Chang, Chih-Hung

    2007-01-01

    Successful integration of modern psychometrics and advanced informatics in patient-reported outcomes (PRO) measurement and management can potentially maximize the value of health outcomes research and optimize the delivery of quality patient care. Unlike the traditional labor-intensive paper-and-pencil data collection method, item response theory-based computerized adaptive testing methodologies coupled with novel technologies provide an integrated environment to collect, analyze and present ready-to-use PRO data for informed and shared decision-making. This article describes the needs, challenges and solutions for accurate, efficient and cost-effective PRO data acquisition and dissemination means in order to provide critical and timely PRO information necessary to actively support and enhance routine patient care in busy clinical settings.

  9. 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.

  10. Performance-based versus self-reported outcomes using the HOOS following total hip arthroplasty

    PubMed Central

    Dayton, Michael R.; Judd, Dana L.; Hogan, Craig A.; Stevens-Lapsley, Jennifer E.

    2016-01-01

    Objective The purpose of this study was to explore the relationship between patients’ self-reported and performance-based function after total hip arthroplasty (THA). Design Twenty-three patients (age 61.4 ± 8.3 years) undergoing primary THA for hip osteoarthritis participated. Self-reported function and recovery was measured using The Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) ADL and Pain subscales. Performance-based functional measures included Timed Up and Go Test (TUG), Stair Climbing Test (SCT), and the 6 Minute Walk Test (6MW). Outcome measures were assessed pre- and post-operatively at one and six months. Results One month after THA, performance-based function declined compared to baseline as follows: TUG: −22.1 ± 25.4%; SCT: −58.5 ± 63.6%; and 6MWT: −22.6 ± 31.7%. In contrast, self-reported function on the HOOS ADL significantly improved one month after THA compared to baseline: 40.8 ± 33.3%. One to six months after THA, there were significant improvements in TUG, SCT and 6MWT which paralleled improvements on the HOOS subscales, although changes were not significantly correlated. Conclusion The disparity between changes in HOOS scores and functional performance post-operatively suggests that patients may overestimate their functional capacity early after THA, likely in response to pain improvements over the same time period. Therefore, outcomes assessment after THA should include both self-report and performance-based functional measures. PMID:26259051

  11. 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

  12. 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

  13. 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.

  14. 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

  15. 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…

  16. Race Matters: A Systematic Review of Racial/Ethnic Disparity in Society for Assisted Reproductive Technology (SART) Reported Outcomes

    PubMed Central

    Fujimoto, Victor Y.; Baker, Valerie L.; Barrington, Debbie S.; Broomfield, Diana; Catherino, William H.; Richard-Davis, Gloria; Ryan, Mary; Thornton, Kim; Armstrong, Alicia Y.

    2012-01-01

    Objective To systematically review the reporting of race/ethnicity in SART Clinic Outcome Reporting System (CORS) publications. Design Systematic review using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology of literature published in PUBMED on race/ethnicity that includes data from SART CORS. Setting Systematic review was performed on behalf of the ASRM Health Disparities Special Interest Group. Population IVF cycles reported to SART Exposure Race/ethnicity Main Outcome Measure Any outcomes reported in SART CORS Results Seven publications were identified that assessed racial/ethnic disparities in IVF outcomes using SART data. All reported a racial/ethnic disparity. However, over 35% of cycles were excluded from analysis because of missing race/ethnicity data. Conclusions Review of current publications of SART data suggests significant racial/ethnic disparities in IVF outcomes. However, the potential for selection bias limits confidence in these findings given that fewer than 65% of SART reported cycles include race/ethnicity. Our understanding of how race/ethnicity influences ART outcome could be greatly improved if information on race/ethnicity was available for all reported cycles. PMID:22698638

  17. Parental authority questionnaire.

    PubMed

    Buri, J R

    1991-08-01

    A questionnaire was developed for the purpose of measuring Baumrind's (1971) permissive, authoritarian, and authoritative parental authority prototypes. It consists of 30 items per parent and yields permissive, authoritarian, and authoritative scores for both the mother and the father; each of these scores is derived from the phenomenological appraisals of the parents' authority by their son or daughter. The results of several studies have supported the Parental Authority Questionnaire as a psychometrically sound and valid measure of Baumrind's parental authority prototypes, and they have suggested that this questionnaire has considerable potential as a valuable tool in the investigation of correlates of parental permissiveness, authoritarianism, and authoritativeness.

  18. Parental authority questionnaire.

    PubMed

    Buri, J R

    1991-08-01

    A questionnaire was developed for the purpose of measuring Baumrind's (1971) permissive, authoritarian, and authoritative parental authority prototypes. It consists of 30 items per parent and yields permissive, authoritarian, and authoritative scores for both the mother and the father; each of these scores is derived from the phenomenological appraisals of the parents' authority by their son or daughter. The results of several studies have supported the Parental Authority Questionnaire as a psychometrically sound and valid measure of Baumrind's parental authority prototypes, and they have suggested that this questionnaire has considerable potential as a valuable tool in the investigation of correlates of parental permissiveness, authoritarianism, and authoritativeness. PMID:16370893

  19. 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

  20. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology

    PubMed Central

    Azar, Marleine; Riehm, Kira E.; McKay, Dean; Thombs, Brett D.

    2015-01-01

    Background Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Methods Eligible RCTs were published in JCCP in 2013–2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Results Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). Conclusions The quality of published outcome analysis

  1. The Koala Fear Questionnaire: a standardized self-report scale for assessing fears and fearfulness in pre-school and primary school children.

    PubMed

    Muris, Peter; Meesters, Cor; Mayer, Birgit; Bogie, Nicole; Luijten, Monique; Geebelen, Elke; Bessems, Judith; Smit, Carelijn

    2003-05-01

    The Koala Fear Questionnaire (KFQ) is a standardized self-report scale for assessing fears and fearfulness in children aged between 4 and 12 years. The current article presents six studies which examined the reliability and validity of the KFQ. Study 1 (N=108) demonstrated that the visual fear scales of Koala bears as employed in the KFQ are highly comparable to the standard 3-point scales that are used in other childhood fear measures. Study 2 (N=163) provided support for the convergent validity of the KFQ in a sample of 8- to 14-year-old children. That is, the scale correlated substantially with alternative measures of childhood fear and anxiety. Study 3 (N=189) showed that the KFQ possesses good internal consistency and test-retest stability in a group of 8- to 11-year-old children. The results of Studies 4 (N=129) and 5 (N=176) indicated that the KFQ is suitable for children aged 4 to 6 years and demonstrated that the psychometric properties of the scale in younger children are highly similar to those obtained in older children. Study 6 (N=926) showed that the factor structure of the KFQ was theoretically meaningful: although the data clearly pointed in the direction of one factor of general fearfulness, spurs of the commonly found five-factor solution of childhood fear were found in the KFQ. Altogether, the KFQ seems to be a valuable addition to the instrumentarium of clinicians and researchers who are working with fearful and anxious children. PMID:12711267

  2. 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.

  3. Confirmatory factor analysis and factorial invariance analysis of the adolescent self-report Strengths and Difficulties Questionnaire: how important are method effects and minor factors?

    PubMed

    van de Looij-Jansen, Petra M; Goedhart, Arnold W; de Wilde, Erik J; Treffers, Philip D A

    2011-06-01

    OBJECTIVES. This study examined the factor structure of the self-report Strengths and Difficulties Questionnaire, paying special attention to the number of factors and to negative effects of reverse-worded items and minor factors within the subscales on model fit. Furthermore, factorial invariance across gender, age, level of education, and ethnicity was investigated. DESIGN. Data were obtained from the Youth Health Monitor Rotterdam, a community-based health surveillance system. METHODS. The sample consisted of 11,881 pupils of 11-16 years old. Next to the original five-factor model, a factor model with the number of factors based on parallel analysis and scree test was investigated. Confirmatory factor analysis for ordered-categorical measures was applied to examine the goodness-of-fit and factorial invariance of the factor models. RESULTS. After allowing reverse-worded items to cross-load on the prosocial behaviour factor and adding error correlations, a good fit to the data was found for the original five-factor model (emotional symptoms, conduct problems, hyperactivity-inattention, peer problems, prosocial behaviour) and a model with four factors (emotional symptoms and peer problems, conduct problems, hyperactivity-inattention, prosocial behaviour). Factorial invariance across gender, age, level of education, and ethnicity was found for the final five- and four-factor model, except for the prosocial factor of the four-factor model that showed partial invariance across gender. Conclusions. While support was found for both models, the final five-factor model is theoretically more plausible and gained additional support as the original scales emotional problems and peer problems showed different relations with gender, educational level, and ethnicity. PMID:21545447

  4. 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.

  5. Assessing Treatment Options Based on Expected Long-Term Results: Case Report Demonstrates 6-Year Outcomes.

    PubMed

    McMaster, Douglas E

    2015-05-01

    A patient whose chief concern was the esthetics of her anterior teeth presented for a second opinion after it had been recommended that crowns be placed throughout her mouth. Examination revealed numerous defective and some fractured restorations with recurring caries. With treatment goals including creating and maintaining a healthy periodontal environment, leveling the occlusal plane, and decreasing biomechanical risk, the treatment plan incorporated an interdisciplinary approach that utilized orthodontics, a Kois deprogrammer, and implant therapy. Demonstrating 6-year outcomes, this report discusses use of a method to assess treatment options based on expected long-term results.

  6. Patient-reported outcomes as end points in clinical trials in rheumatoid arthritis

    PubMed Central

    Gossec, Laure; Dougados, Maxime; Dixon, William

    2015-01-01

    There is a growing interest in patient-reported outcomes (PROs) in rheumatology, which goes with a global trend for more ‘patient-centred care’. This review considers the use of PROs in trials, including their strengths and limitations. In rheumatoid arthritis (RA) trials, the most frequently used PROs to assess treatments include pain, patient global assessment, assessment of functional status, but also health-related quality of life and less commonly fatigue. Other aspects of importance for patients, such as sleep, psychological well-being or ability to cope, are rarely assessed. PROs as outcome measures in RA trials have strengths as well as limitations. PROs have face validity, they are reproducible and sensitive to change and they bring additional information beyond joint counts or acute phase reactants. However, their predictive validity for later outcomes has been little explored, some PROs show redundancy (they bring similar information) and, due to the apparently moderate link between some PROs such as fatigue and the disease process, the use of some PROs to inform treatment choices has been questioned. We suggest the choice of PROs for trials depends on the study objective and on the viewpoint of the stakeholder. There needs to be agreed prioritisation across all stakeholders about what is most important to collect in a trial, which is why a prioritisation and selection process is necessary. Trials in RA will continue to include PROs and their interpretation will become easier as our knowledge progresses. PMID:26509052

  7. Patient-reported outcomes as end points in clinical trials in rheumatoid arthritis.

    PubMed

    Gossec, Laure; Dougados, Maxime; Dixon, William

    2015-01-01

    There is a growing interest in patient-reported outcomes (PROs) in rheumatology, which goes with a global trend for more 'patient-centred care'. This review considers the use of PROs in trials, including their strengths and limitations. In rheumatoid arthritis (RA) trials, the most frequently used PROs to assess treatments include pain, patient global assessment, assessment of functional status, but also health-related quality of life and less commonly fatigue. Other aspects of importance for patients, such as sleep, psychological well-being or ability to cope, are rarely assessed. PROs as outcome measures in RA trials have strengths as well as limitations. PROs have face validity, they are reproducible and sensitive to change and they bring additional information beyond joint counts or acute phase reactants. However, their predictive validity for later outcomes has been little explored, some PROs show redundancy (they bring similar information) and, due to the apparently moderate link between some PROs such as fatigue and the disease process, the use of some PROs to inform treatment choices has been questioned. We suggest the choice of PROs for trials depends on the study objective and on the viewpoint of the stakeholder. There needs to be agreed prioritisation across all stakeholders about what is most important to collect in a trial, which is why a prioritisation and selection process is necessary. Trials in RA will continue to include PROs and their interpretation will become easier as our knowledge progresses. PMID:26509052

  8. The impact of newer atypical antipsychotics on patient-reported outcomes in schizophrenia.

    PubMed

    Awad, A George; Voruganti, Lakshmi N P

    2013-08-01

    Over the past two decades there has been increasing interest in including patients' self-reports in the management of their illness. Among the many reasons for such recent interest has been a rising consumer movement over the past few decades, which has led patients, their caregivers and their families to press for more meaningful sharing with physicians in the clinical decision-making process, with the clear expectations of better therapies and improved outcomes. Patients as consumers of services, their views, attitudes towards healthcare, as well as their level of satisfaction with care, have become increasingly recognized. The recent interest by the US Food and Drug Administration (FDA), as well as other regulatory agencies, in patient-reported outcomes (PROs) in the process of developing and testing new antipsychotics, has also added more impetus. It is clear that including patients in the decision-making process about the management of their psychiatric conditions also broadens the concept of 'recovery', by empowering patients to be active participants and gives a clear message that successful treatment in schizophrenia is more than a symptomatic improvement, but also includes improved functional status. Additionally, the recent interest in personalized medicine puts the patient in the centre of such development. Since 2004, when we published our review about the impact of new antipsychotics on quality of life in CNS Drugs, a number of newer antipsychotics have been introduced and include ziprasidone, aripiprazole, paliperidone, asenapine, iloperidone and lurasidone. The current review is based on 31 selected publications that cover the years 2004-2012, and deals with the impact of such newer antipsychotics on specific domains of PROs, such as subjective tolerability, quality of life, medication preference, satisfaction and social functioning. Most of the available data deal with ziprasidone, aripiprazole and paliperidone. Though the great majority of the

  9. 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

  10. Psychometric Characteristics of a Patient Reported Outcome Measure on Ego-Integrity and Despair among Cancer Patients

    PubMed Central

    Kleijn, Gitta; Post, Lenneke; Witte, Birgit I.; Bohlmeijer, Ernst T.; Westerhof, Gerben J.; Cuijpers, Pim; Verdonck-de Leeuw, Irma M.

    2016-01-01

    Purpose To evaluate psychometric characteristics of a questionnaire (the Northwestern Ego-integrity Scale (NEIS)) on ego-integrity (the experience of wholeness and meaning in life, even in spite of negative experiences) and despair (the experience of regret about the life one has led, and feelings of sadness, failure and hopelessness) among cancer patients. Methods Cancer patients (n = 164) completed patient reported outcome measures on ego-integrity and despair (NEIS), psychological distress, anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), and quality of life (EORTC QLQ-C30 (cancer survivors, n = 57) or EORTC QLQ-C15-PAL (advanced cancer patients, n = 107)). Confirmatory Factor Analysis was used to assess construct validity. Cronbach’s alpha was used to assess internal consistency. Convergent validity was tested based on a priori defined hypotheses: a higher level of ego-integrity was expected to be related to a higher level of quality of life, and lower levels of distress, depression and anxiety; a higher level of despair was expected to be related to a lower level of quality of life, and higher levels of distress, depression and anxiety. Results The majority of all items (94.5%) of the NEIS were completed by patients and single item missing rate was below 2%. The two subscales, labeled as Ego-integrity (5 items) and Despair (4 items) had acceptable internal consistency (Cronbach’s alpha .72 and .61, respectively). The Ego-integrity subscale was not significantly associated with quality of life, distress, anxiety, or depression. The Despair subscale correlated significantly (p <.001) with quality of life (r = -.29), distress (r = .44), anxiety (r = .47) and depression (r = .32). Conclusion The NEIS has good psychometric characteristics to assess ego-integrity and despair among cancer patients. PMID:27195750

  11. Development of a questionnaire to assess medical competencies: Reliability and validity of the Questionnaire

    PubMed Central

    Giesler, Marianne; Forster, Johannes; Biller, Silke; Fabry, Götz

    2011-01-01

    Introduction: While preparing a graduate survey for medical education in 2008 we realized that no instrument existed that would be suitable to evaluate whether the learning outcomes outlined in the Medical Licensure Act (ÄAppO) would be met. Therefore we developed the Freiburg Questionnaire to Assess Competencies in Medicine (Freiburger Fragebogen zur Erfassung von Kompetenzen in der Medizin, FKM)1 which has been revised and extended several times since then. Currently the FKM includes 45 items which are assigned to nine domains that correspond to the CanMEDS roles: medical expertise, communication, team-work, health and prevention, management, professionalism, learning, scholarship, and personal competencies. Methods: In order to test the reliability and validity of the questionnaire we have repeatedly surveyed medical students and residents since May 2008. In this article we report on the results of a cross-sectional study with 698 medical students from the preclinical and clinical years. In addition, we report the results of a survey of 514 residents who were up to two years into their residency. Results and conclusions: In summary, results show that the scales of the FKM are reliable (Cronbach’s α between .68 and .97). Significant differences in means between selected groups of students support the measure’s construct validity. Furthermore, there is evidence that the FKM might be used as a screening tool e.g. in graduate surveys to identify weaknesses in the medical education curriculum. PMID:21818241

  12. 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.

  13. Variations in the reporting of outcomes used in systematic reviews of treatment effectiveness research in bladder pain syndrome.

    PubMed

    Tirlapur, Seema A; Ni Riordain, Richeal; Khan, Khalid S

    2014-09-01

    This paper investigates the quality of outcomes reported in systematic reviews and randomised controlled trials (RCTs) of bladder pain syndrome and its relationship with study quality and journal impact factor. We searched until August 2013 the Cochrane Library, EMBASE, Medline, CINAHL, LILACS and SIGLE, without language restrictions. Quality of outcome reporting in systematic reviews and constituent RCTs was assessed using a 6-point scale. Overall study quality was assessed using the AMSTAR and Jadad scoring systems, and impact factor in the year of publication was noted. Spearman's rank correlation was calculated. There were 8 systematic reviews, with a total of 28 RCTs (1732 patients), reporting 5 outcomes using 19 different measurement scales. The outcomes reported in individual RCTs were urinary symptoms (100%), pain (64%), quality of life (39%), general wellbeing (36%) and bladder capacity (36%). The mean quality of outcomes reported was 1.63 (95% CI 0.29-2.96) for systematic reviews and 3.25 (95% CI 2.80-3.70) for RCTs. The quality of outcomes reported showed correlation with overall study quality (0.90, 95% CI 0.79-0.95, p<0.0001) but not with journal impact factor (0.07, 95% CI -0.31-0.43, p=0.35). Multivariable linear regression showed a relationship between quality of outcome reporting and study quality (β=0.05, p<0.0001), adjusting for effects of study type, impact factor and journal type. There is a need to generate consensus over a set of core outcomes in bladder pain syndrome using standardised reporting tools and to disseminate these through good publication practice. PMID:25020277

  14. Development and Validation of the Keele Musculoskeletal Patient Reported Outcome Measure (MSK-PROM)

    PubMed Central

    2015-01-01

    Objective To develop and validate a patient report outcome measure (PROM) for clinical practice that can monitor health status of patients with a range of musculoskeletal (MSK) disorders. Methods Constructs for inclusion in the MSK-PROM were identified from a consensus process involving patients with musculoskeletal conditions, clinicians, purchasers of healthcare services, and primary care researchers. Psychometric properties of the brief tool, including face and construct validity, repeatability and responsiveness were assessed in a sample of patients with musculoskeletal pain consulting physiotherapy services in the United Kingdom (n=425). Results The consensus process identified 10 prioritised domains for monitoring musculoskeletal health status: pain intensity, quality of life, physical capacity, interference with social/leisure activities, emotional well-being, severity of most difficult thing, activities and roles, understanding independence, and overall impact. As the EuroQol (EQ-5D-5L) is a widely adopted PROMs tool and covers the first four domains listed, to reduce patient burden to a minimum the MSK-PROM was designed to capture the remaining six prioritised domains which are not measured by the EQ-5D-5L. The tool demonstrated excellent reliability, construct validity, responsiveness and acceptability to patients and clinicians for use in clinical practice. Conclusion We have validated a brief patient reported outcome measure (MSK-PROM) for use in clinical practice to measure musculoskeletal health status and monitor outcomes over time using domains that are meaningful to patients and sensitive to change. Further work will establish whether the MSK-PROM is useful in other musculoskeletal healthcare settings. PMID:25928807

  15. 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

  16. Can we agree on patient-reported outcome measures for assessing hematopoietic cell transplantation patients? A study from the CIBMTR and BMT CTN.

    PubMed

    Shaw, B E; Lee, S J; Horowitz, M M; Wood, W A; Rizzo, J D; Flynn, K E

    2016-09-01

    Much research into the impact of hematopoietic cell transplantation (HCT) on recipients' symptoms, functioning and health-related quality of life uses diverse patient-reported outcome (PRO) measures. Robust conclusions regarding PROs in HCT patients are constrained by methodological issues, including the use of multiple different and noncomparable assessment measures. We reviewed 114 publications addressing PROs in HCT patients. Although three multi-item measures were most frequently used (FACT-BMT, n=28; European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30, n=26; and SF-36, n=26), 25 additional measures were used in more than one study. Another 50 measures were used in single studies. Over 50% of studies used more than one measure. We recommend that the field agrees upon a set of measures to address the core domains important to patients, to reduce heterogeneity and allow comparisons across studies and between different populations. Measures should be available in a free and easily accessible manner internationally. We discuss the relative benefits of the National Institutes of Health-supported Patient-Reported Outcomes Measurement Information System (PROMIS) system to achieve these goals. To further address these issues, the Blood and Marrow Transplant Clinical Trials Network has recently created a task force to implement PROMIS measures alongside traditional PRO measures in future clinical trials. Robust comparisons between measures in this setting may allow for the development of a standard for HCT patients. PMID:27159181

  17. 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…

  18. [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). PMID:22981026

  19. 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.

  20. Quality of life as patient-reported outcomes: principles of assessment

    PubMed Central

    Bullinger, Monika; Quitmann, Julia

    2014-01-01

    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. PMID:25152653

  1. Systematic collection of patient reported outcome research data: A checklist for clinical research professionals.

    PubMed

    Wehrlen, Leslie; Krumlauf, Mike; Ness, Elizabeth; Maloof, Damiana; Bevans, Margaret

    2016-05-01

    Understanding the human experience is no longer an outcome explored strictly by social and behavioral researchers. Increasingly, biomedical researchers are also including patient reported outcomes (PROs) in their clinical research studies not only due to calls for increased patient engagement in research but also healthcare. Collecting PROs in clinical research studies offers a lens into the patient's unique perspective providing important information to industry sponsors and the FDA. Approximately 30% of trials include PROs as primary or secondary endpoints and a quarter of FDA new drug, device and biologic applications include PRO data to support labeling claims. In this paper PRO, represents any information obtained directly from the patient or their proxy, without interpretation by another individual to ascertain their health, evaluate symptoms or conditions and extends the reference of PRO, as defined by the FDA, to include other sources such as patient diaries. Consumers and clinicians consistently report that PRO data are valued, and can aide when deciding between treatment options; therefore an integral part of clinical research. However, little guidance exists for clinical research professionals (CRPs) responsible for collecting PRO data on the best practices to ensure quality data collection so that an accurate assessment of the patient's view is collected. Therefore the purpose of this work was to develop and validate a checklist to guide quality collection of PRO data. The checklist synthesizes best practices from published literature and expert opinions addressing practical and methodological challenges CRPs often encounter when collecting PRO data in research settings. PMID:27002223

  2. Patient-Reported Outcomes in Male and Female Collegiate Soccer Players During an Athletic Season

    PubMed Central

    Hoch, Johanna M.; Druvenga, Beth; Ferguson, Brittany A.; Houston, Megan N.; Hoch, Matthew C.

    2015-01-01

    Context  Clinicians are urged to document patient-based outcomes during rehabilitation to measure health-related quality of life (HRQOL) from the patient's perspective. It is unclear how scores on patient-reported outcome instruments (PROs) vary over the course of an athletic season because of normal athletic participation. Objective  Our primary purpose was to evaluate the effect of administration time point on HRQOL during an athletic season. Secondary purposes were to determine test-retest reliability and minimal detectable change scores of 3 PROs commonly used in clinical practice and if a relationship exists between generic and region-specific outcome instruments. Design  Cross-sectional study. Setting  Athletic facility. Patients or Other Participants  Twenty-three collegiate soccer athletes (11 men, 12 women). Main Outcome Measure(s)  At 5 time points over a spring season, we administered the Disablement in the Physically Active Scale (DPA), Foot and Ankle Ability Measure-Sport, and Knee Injury and Osteoarthritis Outcome Score (KOOS). Results  Time effects were observed for the DPA (P = .011) and KOOS Quality of Life subscale (P = .027). However, the differences between individual time points did not surpass the minimal detectable change for the DPA, and no post hoc analyses were significant for the KOOS-Quality of Life subscale. Test-retest reliability was moderate for the KOOS-Pain subscale (intraclass correlation coefficient = 0.71) and good for the remaining KOOS subscales, DPA, and Foot and Ankle Ability Measure-Sport (intraclass correlation coefficients > 0.79). The DPA and KOOS-Sport subscale demonstrated a significant moderate relationship (P = .018). Conclusions  Athletic participation during a nontraditional, spring soccer season did not affect HRQOL. All 3 PROs were reliable and could be used clinically to monitor changes in health status throughout an athletic season. Our results demonstrate that significant deviations in scores

  3. 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

  4. 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

  5. Responsive Professional Education: Balancing Outcomes and Opportunities. ASHE-ERIC Higher Education Report No. 3, 1986.

    ERIC Educational Resources Information Center

    Stark, Joan S.; And Others

    Goals and outcomes in various fields of professional education are considered. Attention is directed to generic outcomes of professional preparation, the emphasis these outcomes receive among professional educators, some problems that concern professional educators, and recommendations for future action and study. The generic outcomes, which were…

  6. A Prospective Study of the Feasibility and Acceptability of a Web-Based, Electronic Patient-Reported Outcomes System in Assessing Patient Recovery after Major Gynecologic Cancer Surgery

    PubMed Central

    Andikyan, Vaagn; Rezk, Youssef; Einstein, M Heather; Gualtiere, Gina; Leitao, Mario M; Sonoda, Yukio; Abu-Rustum, Nadeem R; Barakat, Richard R; Basch, Ethan M; Chi, Dennis S

    2013-01-01

    Purpose The purposes of this study are to evaluate the feasibility of capturing patient-reported outcomes (PROs) electronically and to identify the most common distressing symptoms in women recovering from major gynecologic cancer surgery. Methods This was a prospective, single-arm pilot study. Eligible participants included those scheduled for a laparotomy for presumed or known gynecologic malignancy. Patients completed a Web-based “STAR” (Symptoms Tracking and Reporting for Patients) questionnaire once preoperatively and weekly during the 6-week postoperative period. The questionnaire consisted of the patient adaptation of the NCI CTCAE 3.0 and EORTC QLQ-C30 3.0. When a patient submitted a response that was concerning, an automated email alert was sent to the clinician. The patient’s assessment of STAR’s usefulness was measured via an exit survey. Results Forty-nine patients completed the study. The procedures included the following: hysterectomy +/− staging (67%), resection of tumor (22%), salpingo-oophorectomy (6%), and other (4%). Most patients (82%) completed at least 4 sessions in STAR. The CTC generated 43 alerts. These alerts resulted in 25 telephone contacts with patients, 2 ER referrals, one new appointment, and one pharmaceutical prescription. The 3 most common patient-reported symptoms generating an alert were as follows: poor performance status (19%), nausea (18%), and fatigue (17%). Most patients found STAR useful (80%) and would recommend it to others (85%). Conclusion Application of a Web-based, electronic STAR system is feasible in the postoperative period, highly accepted by patients, and warrants further study. Poor performance status, nausea, and fatigue were the most common distressing patient-reported symptoms. PMID:22871467

  7. Patient-Reported Outcomes and Total Health Care Expenditure in Prediction of Patient Satisfaction: Results From a National Study

    PubMed Central

    Zhang, Weiping; Chen, Wei; Bounsanga, Jerry; Cheng, Christine; Franklin, Jeremy D; Crum, Anthony B; Voss, Maren W; Hon, Shirley D

    2015-01-01

    Background Health care quality is often linked to patient satisfaction. Yet, there is a lack of national studies examining the relationship between patient satisfaction, patient-reported outcomes, and medical expenditure. Objective The aim of this study is to examine the contribution of physical health, mental health, general health, and total health care expenditures to patient satisfaction using a longitudinal, nationally representative sample. Methods Using data from the 2010-2011 Medical Expenditure Panel Survey, analyses were conducted to predict patient satisfaction from patient-reported outcomes and total health care expenditures. The study sample consisted of adult participants (N=10,157), with sampling weights representative of 233.26 million people in the United States. Results The results indicated that patient-reported outcomes and total health care expenditure were associated with patient satisfaction such that higher physical and mental function, higher general health status, and higher total health care expenditure were associated with higher patient satisfaction. Conclusions We found that patient-reported outcomes and total health care expenditure had a significant relationship with patient satisfaction. As more emphasis is placed on health care value and quality, this area of research will become increasingly needed and critical questions should be asked about what we value in health care and whether we can find a balance between patient satisfaction, outcomes, and expenditures. Future research should apply big data analytics to investigate whether there is a differential effect of patient-reported outcomes and medical expenditures on patient satisfaction across different medical specialties. PMID:27227131

  8. Learning a Third Language. English as a School Language for Bilingual and Multilingual Pupils: A Questionnaire Report. Research Bulletin No. 22

    ERIC Educational Resources Information Center

    Lindblad, Torsten; Lindblad, Anita

    The educational status and English proficiency of immigrants to Sweden at the end of their compulsory schooling was investigated. Questionnaires were completed by 26 schools in 10 Swedish cities regarding the problems associated with the study of English as a third language by immigrant students in the comprehensive school. Schools in districts…

  9. Utility of the "Social Communication Questionnaire-Current" and "Social Responsiveness Scale" as Teacher-Report Screening Tools for Autism Spectrum Disorders

    ERIC Educational Resources Information Center

    Schanding, G. Thomas, Jr.; Nowell, Kerri P.; Goin-Kochel, Robin P.

    2012-01-01

    Limited research exists regarding the role of teachers in screening for Autism Spectrum Disorders (ASD). The current study examined the use of the "Social Communication Questionnaire" (SCQ) and "Social Responsiveness Scale" (SRS) as completed by parents and teachers about school-age children from the Simons Simplex Collection. Using the…

  10. Intensification of the Learning Process: Diagnostic Instruments--Visual Performance Screening Test, Observing the Learner, Questionnaire-Parent. A Series of Reports Designed for Classroom Use.

    ERIC Educational Resources Information Center

    Bucks County Public Schools, Doylestown, PA.

    Instruments for screening visual performance, for observing vision behavior, the learner in general, and the student at a learning task, and a parent questionnaire are described. (See TM 001 363 for a description of the total project; for other related documents, see TM 001 160, 364-368, 370-374.) (MS)

  11. The Utility of Job Dimensions Based on Form B of the Position Analysis Questionnaire (PAQ) in a Job Component Validation Model. Report No. 5.

    ERIC Educational Resources Information Center

    Marquardt, Lloyd D.; McCormick, Ernest J.

    The study involved the use of a structured job analysis instrument called the Position Analysis Questionnaire (PAQ) as the direct basis for the establishment of the job component validity of aptitude tests (that is, a procedure for estimating the aptitude requirements for jobs strictly on the basis of job analysis data). The sample of jobs used…

  12. 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…

  13. 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

    Berger, Marc L; Martin, Bradley C; Husereau, Don; Worley, Karen; Allen, J Daniel; Yang, Winnie; Quon, Nicole C; Mullins, C Daniel; Kahler, Kristijan H; Crown, William

    2014-03-01

    Evidence-based health care 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. Widespread adoption of evidence from observational studies, however, has been limited because of various 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 Task Force addressing 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.

  14. Development of Follow-Up Questionnaires for Vocational and Transfer Students at the El Paso Community College and Development of Faculty Motivation Scales. Consulting Report.

    ERIC Educational Resources Information Center

    Whitmore, Paul G.

    The primary purpose of the student follow-up questionnaires was to identify instructional and curricular deficiencies in sufficiently specific terms to provide a basis for correcting the deficiencies. This effort was part of the evaluation component of a program dealing with the systematization of instruction. Two instruments were developed: one…

  15. The Establishment of the GENEQOL Consortium to Investigate the Genetic Disposition of Patient-Reported Quality-of-Life Outcomes

    PubMed Central

    Sprangers, Mirjam A. G.; Sloan, Jeff A.; Veenhoven, Ruut; Cleeland, Charles S.; Halyard, Michele Y.; Abertnethy, Amy P.; Baas, Frank; Barsevick, Andrea M.; Bartels, Meike; Boomsma, Dorret I.; Chauhan, Cynthia; Dueck, Amylou C.; Frost, Marlene H.; Hall, Per; Klepstad, Pål; Martin, Nicholas G.; Miaskowski, Christine; Mosing, Miriam; Movsas, Benjamin; Van Noorden, Cornelis J. F.; Patrick, Donald L.; Pedersen, Nancy L.; Ropka, Mary E.; Shi, Quiling; Shinozaki, Gen; Singh, Jasvinder A.; Yang, Ping; Zwinderman, Ailko H.

    2010-01-01

    To our knowledge, no comprehensive, interdisciplinary initiatives have been taken to examine the role of genetic variants on patient-reported quality-of-life outcomes. The overall objective of this paper is to describe the establishment of an international and interdisciplinary consortium, the GENEQOL Consortium, which intends to investigate the genetic disposition of patient-reported quality-of-life outcomes. We have identified five primary patient-reported quality-of-life outcomes as initial targets: negative psychological affect, positive psychological affect, self-rated physical health, pain, and fatigue. The first tangible objective of the GENEQOL Consortium is to develop a list of potential biological pathways, genes and genetic variants involved in these quality-of-life outcomes, by reviewing current genetic knowledge. The second objective is to design a research agenda to investigate and validate those genes and genetic variants of patient-reported quality-of-life outcomes, by creating large datasets. During its first meeting, the Consortium has discussed draft summary documents addressing these questions for each patient-reported quality-of-life outcome. A summary of the primary pathways and robust findings of the genetic variants involved is presented here. The research agenda outlines possible research objectives and approaches to examine these and new quality-of-life domains. Intriguing questions arising from this endeavor are discussed. Insight into the genetic versus environmental components of patient-reported quality-of-life outcomes will ultimately allow us to explore new pathways for improving patient care. If we can identify patients who are susceptible to poor quality of life, we will be able to better target specific clinical interventions to enhance their quality of life and treatment outcomes. PMID:19456223

  16. 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

  17. Impact of natalizumab on patient-reported outcomes in multiple sclerosis: a longitudinal study

    PubMed Central

    2012-01-01

    Background Natalizumab (Tysabri, Biogen Idec and Elan Pharmaceuticals) significantly reduces the relapse rate and disability progression, and improves health-related quality of life (HRQoL), in patients with relapsing-remitting multiple sclerosis. We investigated the impact of natalizumab on patient-reported outcomes (PROs) in a real-world setting. Methods PRO data were collected from patients enrolled in a longitudinal real-world study using validated measures administered as surveys before the patients initiated natalizumab treatment and after the 3rd, 6th, and 12th monthly infusion. HRQoL, ability to carry out daily activities, disability level, and impact on cognitive functioning and fatigue were assessed. Results A total of 333 patients completed 12 months of assessments. After 12 months of natalizumab treatment, 69% to 88% of patients reported a positive outcome (either an improvement or no further decline) in all PRO measures assessed. Significant improvements in general and disease-specific HRQoL were observed after three infusions, both with physical (p < .01) and psychological (p < .001) measures, and were sustained after 12 infusions (all p < .001). The impact of multiple sclerosis on cognitive functioning and fatigue was significantly reduced (both p < .001 after 3 and 12 infusions). Conclusions PRO measures were improved with natalizumab in a real-world setting. The improvements were observed as early as after 3 months and sustained over a 12-month period. The improvements in PROs show that, in clinical practice, the clinical benefits of natalizumab are translated into patient-reported benefits. PMID:23270428

  18. 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.

  19. Assessing outcomes in body contouring.

    PubMed

    Klassen, Anne F; Cano, Stefan J; Scott, Amie; Tsangaris, Elena; Pusic, Andrea L

    2014-10-01

    Patient-reported outcome (PRO) instruments are questionnaires designed to measure outcomes of importance to patients from their perspective. This article describes the methods used to develop a new PRO instrument for obese patients and patients having bariatric and cosmetic body contouring surgery. The BODY-Q is composed of 19 newly designed scales that measure: (1) appearance; (2) health-related quality of life; and (3) process of care. Recommended guidelines for PRO instrument development were followed to ensure that the BODY-Q meets requirements of regulatory bodies. The BODY-Q is currently being field-tested in an international study.

  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. Effect of Public Reporting on Intensive Care Unit Discharge Destination and Outcomes

    PubMed Central

    Reineck, Lora A.; Le, Tri Q.; Seymour, Christopher W.; Barnato, Amber E.; Angus, Derek C.

    2015-01-01

    Rationale: Public reporting of hospital performance is designed to improve healthcare outcomes by promoting quality improvement and informing consumer choice, but these programs may carry unintended consequences. Objective: To determine whether publicly reporting in-hospital mortality rates for intensive care unit (ICU) patients influenced discharge patterns or mortality. Methods: We performed a retrospective cohort study taking advantage of a natural experiment in which California, but not other states, publicly reported hospital-specific severity-adjusted ICU mortality rates between 2007 and 2012. We used multivariable logistic regression adjusted for patient, hospital, and regional characteristics to compare mortality rates and discharge patterns between California and states without public reporting for Medicare fee-for-service ICU admissions from 2005 through 2009 using a difference-in-differences approach. Measurements and Main Results: We assessed discharge patterns using post-acute care use and acute care hospital transfer rates and mortality using in-hospital and 30-day mortality rates. The study cohort included 936,063 patients admitted to 646 hospitals. Compared with control subjects, admission to a California ICU after the introduction of public reporting was associated with a reduced odds of post-acute care use in post-reform year 2 (ratio of odds ratios [ORs], 0.94; 95% confidence interval [CI], 0.91–0.96) and increased odds of transfer to another acute care hospital in both post-reform years (year 1: ratio of ORs, 1.08; 95% CI, 1.01–1.16; year 2: ratio of ORs, 1.43; 95% CI, 1.33–1.53). There were no significant differences in in-hospital or 30-day mortality. Conclusions: Public reporting of ICU in-hospital mortality rates was associated with changes in discharge patterns but no change in risk-adjusted mortality. PMID:25521696

  2. The Chauvet 2014 Meeting Report: Psychiatric and Psychosocial Evaluation and Outcomes of Upper Extremity Grafted Patients.

    PubMed

    Jowsey-Gregoire, Sheila G; Kumnig, Martin; Morelon, Emmanuel; Moreno, Elisa; Petruzzo, Palmina; Seulin, Christian

    2016-07-01

    Under the auspices for the International Society on Hand and Composite Tissue Allotransplantation, a section of The Transplantation Society (IHCTAS), a meeting was convened on March 21-22, 2014 in Paris to review the following areas that were deemed significant in the understanding of the psychosocial evaluation and outcomes of upper extremity transplant recipients: required domains of the evaluation, screening instruments, clinical monitoring pretransplant, clinical monitoring posttransplant, patient and team expectations, body image, psychiatric complications, functional goals and quality of life, ethics and media relations. Experts in the fields of psychiatry and psychology, transplantation, social work, ethics, and transplant administration met and reviewed center experiences and literature. The attendees highlighted the importance and the complexity of the psychiatric assessment in this field of transplantation. Moreover, the necessity to develop common instruments and evaluation protocols to predict psychosocial outcomes as well as to understand whether we are transplanting the right patients and how the transplantation is affecting the patients were pointed out. Psychiatric complications in upper extremity transplanted patients have been reported by the majority of teams. Preexisting psychiatric difficulties, the initial trauma of amputation, or adjusting to the transplantation process itself (especially the medical follow-up and rehabilitation process) appeared to be important factors. Monitoring during the whole follow-up was recommended to detect psychiatric issues and to facilitate and ensure long-term adherence. The participants proposed an annual meeting format to build upon the findings of this inaugural meeting to be called the Chauvet Workgroup meeting. PMID:26636738

  3. Patient-Reported Outcomes Following Living Kidney Donation: A Single Center Experience

    PubMed Central

    Rodrigue, James R.; Vishnevsky, Tanya; Fleishman, Aaron; Brann, Tracy; Evenson, Amy R.; Pavlakis, Martha; Mandelbrot, Didier A.

    2015-01-01

    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. PMID:26123551

  4. Infantile Hepatic Hemangioendothelioma Associated With Congestive Heart Failure: Two Case Reports With Different Outcomes.

    PubMed

    Wang, Tao; Wang, Yibin; Liang, Yun; Lu, Guoyan

    2015-12-01

    Infantile hepatic hemangioendothelioma (IHH) is rare which can regress spontaneously. Arteriovenous shunts within hemangiomas, however, may result in pulmonary artery hypertension (PAH) and congestive heart failure (CHF).The authors report 2 young infants suffering from multifocal IHH associated with CHF were both treated with glucocorticoid and transcatheter arterial embolization (TAE), but had different outcomes. The PAH decreased immediately and the symptoms of CHF were alleviated after TAE for both of them. For the Tibetan infant, the development was normal with tumor regression by follow-up. For the Han ethnic neonate, PAH increased again in the seventh day with progressive cardiovascular insufficiency. Ultrasound showed a persisting perfusion caused by collateralization around occluded main feeders. Furthermore, a pulmonary infection occurred and ventilation was performed. As a result, the infant died from multiorgan failure caused by CHF and infection.TAE is a treatment of reducing shunting for hemangiomas. Fistula recanalization in multifocal IHH, however, might be an important risk factor affecting the outcome of TAE. TAE should be further evaluated with special attention to anatomy of feeding and draining vessels, and cardiopulmonary conditions. In addition, the patients were susceptible to secondary pulmonary infection because of lung congestion. As well, the infant from the high altitude area showed better adaptability to hypoxia.

  5. The Depression Coping Questionnaire.

    ERIC Educational Resources Information Center

    Kleinke, Chris L.

    College students (N=396), chronic pain patients (N=319), and schizophrenic veterans (N=43) completed the Depression Coping Questionnaire (DCQ) and the Beck Depression Inventory (BDI). Factor analysis of the DCQ identified eleven coping responses: social support, problem solving, self-blame/escape, aggression, indulgence, activities, medication,…

  6. Reporting of IMMPACT-recommended core outcome domains among trials assessing opioids for chronic non-cancer pain.

    PubMed

    Mulla, Sohail M; Maqbool, Amna; Sivananthan, Laxsanaa; Lopes, Luciane C; Schandelmaier, Stefan; Kamaleldin, Mostafa; Hsu, Sandy; Riva, John J; Vandvik, Per Olav; Tsoi, Ludwig; Lam, Tommy; Ebrahim, Shanil; Johnston, Bradley C; Olivieri, Lori; Montoya, Luis; Kunz, Regina; Scheidecker, Anne; Buckley, D Norman; Sessler, Daniel I; Guyatt, Gordon H; Busse, Jason W

    2015-09-01

    The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) has recommended that trialists evaluating treatments for chronic pain should consider reporting 9 patient-important outcome domains. We examined the extent to which clinical trials evaluating the effect of opioids for chronic non-cancer pain (CNCP) report outcome domains recommended by IMMPACT. We systematically searched electronic databases for English-language studies that randomized patients with CNCP to receive an opioid or a non-opioid control. In duplicate and independently, reviewers established the eligibility of each identified study and recorded all reported outcome domains from eligible trials. We conducted a priori regression analyses to explore factors that may be associated with IMMPACT-recommended outcome domains. Among 156 eligible trials, reporting of IMMPACT-recommended outcome domains was highly variable, ranging from 99% for pain to 7% for interpersonal functioning. Recently published trials were more likely to report the effect of treatment on physical functioning, emotional functioning, role functioning, sleep and fatigue, and participant disposition. Trials for which the corresponding author was from North America were more likely to report treatment effects on physical functioning and participant ratings of improvement and satisfaction with treatment. Trials published in higher impact journals were more likely to report treatment effects on emotional function, but less likely to report participant ratings of improvement and satisfaction with treatment. Most IMMPACT domains showed an increased rate of reporting over time, although many patient-important outcome domains remained unreported by over half of all trials evaluating the effects of opioids for CNCP.

  7. Body image in idiopathic scoliosis: a comparison study of psychometric properties between four patient-reported outcome instruments

    PubMed Central

    2014-01-01

    Background Four patient-reported outcome (PRO) instruments are commonly used to assess body image in idiopathic scoliosis (IS): the Quality of Life Profile for Spinal Deformities (QLPSD), SRS-22 Self-Image scale, Spinal Appearance Questionnaire (SAQ), and Trunk Appearance Perception Scale (TAPS). The aim of this study is to compare the psychometric properties of these instruments in patients with IS and report the translational/cultural adaptation of the SAQ to Spanish. Methods The four instruments in a Spanish version were administered to 80 patients with IS aged 10 to 40 years old. The sample was stratified according to scoliosis magnitude (less and more than 45º). Analysis was also conducted for age groups. The psychometric properties studied included convergent and divergent construct validity, as well as internal consistency. Convergent validity was evaluated by correlation analysis between the self-image instruments and Cobb angle. Divergent validity was assessed with correlation analysis between PRO scores and SRS-22 dimensions scores such as Function, Pain and Mental Health. Results In the overall sample, each of the PRO instruments demonstrated high internal consistency (QLPSD Body Image, α = 0.80; SRS-22 Self Image, α = 0.78; SAQ, α = 0.89; TAPS, α = 0.87), also both for younger and adult patients subgroups. Correlation with curve magnitude was significant for each of the four scales. However, the correlation was higher for the pictorial scales (SAQ Appearance r = 0.61, TAPS r = - 0.62) than for the textual scales (QLPSD-bi r = 0.36, SRS-22 Self-Image scale r = - 0.41). In the younger group, correlation between Cobb angle and textual scales (QLPSD-bi and SRS-22 Self-Image Scale) was not significant. Body Image scales showed significant correlations with SRS-22 Pain, Function and Mental Health dimensions. Conclusions All four instruments tested have good psychometric properties. Pictorial scales (SAQ Appearance and

  8. Testing the Validity and Reliability of the Shame Questionnaire among Sexually Abused Girls in Zambia

    PubMed Central

    Michalopoulos, Lynn T. M.; Murray, Laura K.; Kane, Jeremy C.; Skavenski van Wyk, Stephanie; Chomba, Elwyn; Cohen, Judith; Imasiku, Mwiya; Semrau, Katherine; Unick, Jay; Bolton, Paul A.

    2015-01-01

    Purpose The aim of the current study is to test the validity and reliability of the Shame Questionnaire among traumatized girls in Lusaka, Zambia. Methods The Shame Questionnaire was validated through both classical test and item response theory methods. Internal reliability, criterion validity and construct validity were examined among a sample of 325 female children living in Zambia. Sub-analyses were conducted to examine differences in construct validity among girls who reported sexual abuse and girls who did not. Results All girls in the sample were sexually abused, but only 61.5% endorsed or reported that sexual abuse had occurred. Internal consistency was very good among the sample with alpha = .87. Criterion validity was demonstrated through a significant difference of mean Shame Questionnaire scores between girls who experienced 0–1 trauma events and more than one traumatic event, with higher mean Shame Questionnaire scores among girls who had more than one traumatic event (p = .004 for 0–1 compared to 2 and 3 events and p = .016 for 0–1 compared to 4+ events). Girls who reported a history of witnessing or experiencing physical abuse had a significantly higher mean Shame Questionnaire score than girls who did not report a history of witnessing or experiencing physical abuse (p<.0001). There was no significant difference in mean Shame Questionnaire score between girls who reported a sexual abuse history and girls who did not. Exploratory factor analysis indicated a two-factor model of the Shame Questionnaire, with an experience of shame dimension and an active outcomes of shame dimension. Item response theory analysis indicated adequate overall item fit. Results also indicate potential differences in construct validity between girls who did and did not endorse sexual abuse. Conclusions This study suggests the general utility of the Shame Questionnaire among Zambian girls and demonstrates the need for more psychometric studies in low and middle income

  9. Stereotactic Body Radiation Therapy for Prostate Cancer: What is the Appropriate Patient-Reported Outcome for Clinical Trial Design?

    PubMed Central

    Woo, Jennifer Ai-Lian; Chen, Leonard N.; Wang, Hongkun; Cyr, Robyn A.; Bhattasali, Onita; Kim, Joy S.; Moures, Rudy; Yung, Thomas M.; Lei, Siyuan; Collins, Brian Timothy; Suy, Simeng; Dritschilo, Anatoly; Lynch, John H.; Collins, Sean P.

    2015-01-01

    Purpose: Stereotactic body radiation therapy (SBRT) is increasingly utilized as primary treatment for clinically localized prostate cancer. Consensus regarding the appropriate patient-reported outcome (PRO) endpoints for clinical trials evaluating radiation modalities for early stage prostate cancer is lacking. To aid in clinical trial design, this study presents PROs over a 36-month period following SBRT for clinically localized prostate cancer. Methods: Between February 2008 and September 2010, 174 hormone-naïve patients with clinically localized prostate cancer were treated with 35–36.25 Gy SBRT (CyberKnife, Accuray) delivered in 5 fractions. Patients completed the validated Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire at baseline and all follow-ups. The proportion of patients developing a clinically significant decline in each EPIC domain score was determined. The minimally important difference (MID) was defined as a change of one-half the standard deviation from the baseline. Per Radiation Therapy Oncology Group (RTOG) 0938, we also examined the patients who experienced a decline in EPIC urinary domain summary score of >2 points (unacceptable toxicity defined as ≥60% of all patients reporting this degree of decline) and EPIC bowel domain summary score of >5 points (unacceptable toxicity defined as >55% of all patients reporting this degree of decline) from baseline to 1 year. Results: A total of 174 patients at a median age of 69 years received SBRT with a minimum follow-up of 36 months. The proportion of patients reporting a clinically significant decline (MID for urinary/bowel are 5.5/4.4) in EPIC urinary/bowel domain scores was 34%/30% at 6 months, 40%/32.2% at 12 months, and 32.8%/21.5% at 36 months. The patients reporting a decrease in the EPIC urinary domain summary score of >2 points was 43.2% (CI: 33.7%, 54.6%) at 6 months, 51.6% (CI: 43.4%, 59.7%) at 12 months, and 41.8% (CI: 33.3%, 50.6%) at 36 months. The

  10. US FDA patient-reported outcome guidance: great expectations and unintended consequences.

    PubMed

    Fehnel, Sheri; DeMuro, Carla; McLeod, Lori; Coon, Cheryl; Gnanasakthy, Ari

    2013-08-01

    Release of the US FDA patient-reported outcome (PRO) guidance raised expectations within the pharmaceutical industry for the use of PRO measures in support of labeling claims. The FDA developed the guidance with admirable intent, and the recommendations within this document are based on sound scientific principles. However, implementation of the guidance has been somewhat inconsistent within the Study Endpoints and Label Development (SEALD) and across the various FDA-reviewing divisions. Industry and regulatory bodies need to work toward gaining common ground to best support registration of treatments that could extend patients' lives, reduce symptoms, and/or improve health-related quality of life. PROs are valuable tools in communicating these messages, and realistic implementation of the FDA PRO Guidance may truly facilitate this process.

  11. Reproductive outcomes in men with karyotype abnormalities: Case report and review of the literature.

    PubMed

    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. 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. PMID:27577417

  13. Patient-reported outcome measures: an on-line system empowering patient choice.

    PubMed

    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.

  14. 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.

  15. Patterns in the Identification of and Outcomes for Children and Youth with Disabilities. Final Report. NCEE 2010-4005

    ERIC Educational Resources Information Center

    Blackorby, Jose; Schiller, Ellen; Mallik, Sangeeta; Hebbeler, Kathleen; Huang, Tracy; Javitz, Harold; Marder, Camille; Nagle, Katherine; Shaver, Debra; Wagner, Mary; Williamson, Cyndi

    2010-01-01

    Reported here are the results of analyses to describe the patterns of identification and academic and developmental outcomes for children with disabilities, conducted as part of the 2004 National Assessment of the implementation of the Individuals with Disabilities Education Act (IDEA). This report provides background context for National…

  16. Patient-reported outcomes to support medical product labeling claims: FDA perspective.

    PubMed

    Patrick, Donald L; Burke, Laurie B; Powers, John H; Scott, Jane A; Rock, Edwin P; Dawisha, Sahar; O'Neill, Robert; Kennedy, Dianne L

    2007-01-01

    This article concerns development and use of patient-reported outcomes (PROs) in clinical trials to evaluate medical products. A PRO is any report coming directly from patients, without interpretation by physicians or others, about how they function or feel in relation to a health condition and its therapy. PRO instruments are used to measure these patient reports. PROs provide a unique perspective on medical therapy, because some effects of a health condition and its therapy are known only to patients. Properly developed and evaluated PRO instruments also have the potential to provide more sensitive and specific measurements of the effects of medical therapies, thereby increasing the efficiency of clinical trials that attempt to measure the meaningful treatment benefits of those therapies. Poorly developed and evaluated instruments may provide misleading conclusions or data that cannot be used to support product labeling claims. We review selected major challenges from Food and Drug Administration's perspective in using PRO instruments, measures, and end points to support treatment benefit claims in product labeling. These challenges highlight the need for sponsors to formulate desired labeling claim(s) prospectively, to acquire and document information needed to support these claim(s), and to identify existing instruments or develop new and more appropriate PRO instruments for evaluating treatment benefit in the defined population in which they will seek claims.

  17. 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

  18. Comparative Effectiveness of Etanercept and Adalimumab in Patient Reported Outcomes and Injection-Related Tolerability

    PubMed Central

    Navarro-Millán, Iris; Herrinton, Lisa J.; Chen, Lang; Harrold, Leslie; Liu, Liyan; Curtis, Jeffrey R.

    2016-01-01

    Objective To describe patient preferences in selecting specific biologics and compare clinical response using patient reported outcomes (PROs) among patients with rheumatoid arthritis (RA) started on different anti-tumor necrosis factor (TNF) therapies. Methods Participants were enrollees in Kaiser Permanente Northern California. Patients with RA who had at least two provider visits and started a new anti-TNF therapy from 10/2010–8/2011, were eligible for participation in this longitudinal study. Using a telephone survey, patient preferences in biologic selection and RAPID3, MDHAQ, and SF-12 scores were collected at baseline and at 6 months. Patient scores rating injection/infusion-site burning and stinging (ISBS) were collected at 6 months. Results In all, 267 patients with RA responded to the baseline survey, of whom 57% preferred an injectable biologic, 22% preferred an infused biologic, and 21% had no preference. Motivation for injectable biologics was convenience (92%) and for infusion therapy was dislike or lack of self-efficacy for self-injection (16%). After 6 months of treatment with anti-TNF, 70% of the 177 patients who answered the ISBS question reported ISBS with the last dose; on a scale of 1 (none) to 10 (worst), 41% of these reported a score of 2–5; and 29% reported a score of 6–10. Adalimumab users experienced 3.2 times (95% confidence interval 1.2–8.6) the level of ISBS that etanercept users experienced. There were no significant differences in RAPID3, MDHAQ, or SF-12 scores between etanercept or adalimumab initiators. Conclusion Convenience and fear of self-injection were important considerations to patients selecting a biologic drug. Although more convenient, adalimumab associated with more ISBS than did etanercept, and this rate was higher than reported in clinical trials. At 6 months, PROs did not differ between etanercept and adalimumab users. PMID:27007811

  19. 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.

  20. Outcome-Based Education: Its Relevance to State and National Decision Making. Synthesis Report 9.

    ERIC Educational Resources Information Center

    Massanari, Carol B.

    This paper on identifying education outcomes for students with disabilities proposes a framework for applying an outcome-based approach throughout the education system, by looking at the needs of the three major levels of the system (local, state, and national); defining different uses for the term "outcome" in order to achieve consensus and…

  1. 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.

  2. 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

  3. 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.

  4. 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

  5. Patient-reported outcomes and considerations in the management of COPD: focus on aclidinium.

    PubMed

    Lopez-Campos, Jose Luis; Calero, Carmen; Lopez-Ramirez, Cecilia; Asensio-Cruz, Maria Isabel; Márquez-Martín, Eduardo; Ortega-Ruiz, Francisco

    2015-01-01

    Chronic obstructive pulmonary disease (COPD) is a complex heterogeneous disease, in which several factors combine to give the final clinical expression. Both early and more recent studies have shown that forced expiratory volume in one second (FEV1), despite being an extremely important parameter to predict the progression of the disease, is a poor surrogate marker for symptoms perception. Accordingly, patient-reported outcomes (PROs) have gained popularity as a measure of the impact of treatment from the patients' perspective, since they represent the individuals' perception of their health status, beyond any physiological limitations. Several such PROs, therefore, are currently included in multidimensional COPD evaluation. This multidimensional approach helps identify different patient types and individualize, up to a certain point, pharmacological treatment. In this multidimensional approach it is important to highlight the importance of long-acting bronchodilators in COPD treatment strategies. Long-acting bronchodilators are cost-effective and have been shown to achieve the greatest functional and clinical improvements in COPD. As a result, long-acting bronchodilators are now the main pharmacological treatment for COPD at all stages of the disease. Until recently, tiotropium was the leading bronchodilator for the treatment of COPD. The clinical development of this medication, unprecedented in inhaled therapy, involved tens of thousands of patients and yielded consistent outcomes in terms of lung function, symptoms, quality of life, exacerbations, and prognosis. However, new long-acting bronchodilators have recently been developed or are currently under development. In this review, we evaluate the effects of aclidinium bromide, a novel long-acting bronchodilator, on PROs in COPD. Aclidinium is a novel long-acting muscarinic antagonist with a good safety profile for the treatment of COPD, and has proven efficacy in both objective functional measurements and PROs

  6. Association between number of prostate biopsies and patient-reported functional outcomes after radical prostatectomy: implications for active surveillance protocols

    PubMed Central

    Anderson, Christopher B.; Tin, Amy L.; Sjoberg, Daniel D.; Mulhall, John P.; Sandhu, Jaspreet; Laudone, Vincent P.; Eastham, James A.; Scardino, Peter T.; Ehdaie, Behfar

    2016-01-01

    Purpose Men with prostate cancer who progress on active surveillance (AS) are subject to multiple prostate biopsies prior to radical prostatectomy (RP). Our objective was to evaluate whether the number of preoperative prostate biopsies affects functional outcomes after RP. Materials and methods We identified men treated with RP at our institution between 2008 and 2011. At 6 and 12 months post-operatively, patients completed questionnaires assessing erectile and urinary function. Men with preoperative incontinence or erectile dysfunction or who did not complete the questionnaire were excluded. Primary outcomes were urinary and erectile function at 12 months postoperatively. We used logistic regression to estimate the impact of number of prostate biopsies on functional outcomes after adjusting for demographic and clinical factors. Results We identified 2,712 men treated with RP between 2008 and 2011. Most men (80%) had 1 preoperative prostate biopsy, 16% had 2, and 4% had at least 3. On adjusted analysis, erectile function at 12 months was not significantly different for men with 2 (OR 1.25; 95% CI 0.90, 1.75) or 3 or more (OR 1.52; 95% CI 0.84, 2.78) biopsies, compared to those with 1. Similarly, urinary function at 12 months was not significantly different for men with 2 (0.84, 95% CI 0.64, 1.10) or 3 or more (0.99, 95% CI 0.60, 1.61) biopsies compared to those with 1. Conclusions We did not find evidence that more preoperative prostate biopsies adversely affected erectile or urinary function at 12 months following RP. PMID:26118438

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. A Mobile Platform for Administering Questionnaires and Synchronizing Their Answers

    ERIC Educational Resources Information Center

    Ginardi, Maria Germana; Lanzola, Giordano

    2013-01-01

    This paper describes a platform for administering questionnaires on smart-phones and tablets. The project arises from the need of acquiring data for monitoring the outcomes of different homecare interventions. First a model has been defined for representing questionnaires, able to support adaptivity in the dialog with the user and enforce some…

  12. Self-Rated Competences Questionnaires from a Design Perspective

    ERIC Educational Resources Information Center

    Braun, Edith; Woodley, Alan; Richardson, John T. E.; Leidner, Bernhard

    2012-01-01

    This paper provides a theoretical review of self-rated competences questionnaires. This topic is influenced by the ongoing world-wide reform of higher education, which has led to a focus on the learner outcomes of higher education. Consequently, questionnaires on self-rated competences have increasingly been employed. However, self-ratings are…

  13. 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

  14. Regenerative Endodontic Treatment: Report of Two Cases with Different Clinical Management and Outcomes.

    PubMed

    Khoshkhounejad, Mehrfam; Shokouhinejad, Noushin; Pirmoazen, Salma

    2015-06-01

    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 Biodentine(TM) as coronal barriers and different irrigants, which led to different clinical outcomes.

  15. Regenerative Endodontic Treatment: Report of Two Cases with Different Clinical Management and Outcomes.

    PubMed

    Khoshkhounejad, Mehrfam; Shokouhinejad, Noushin; Pirmoazen, Salma

    2015-06-01

    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 Biodentine(TM) as coronal barriers and different irrigants, which led to different clinical outcomes. PMID:26884781

  16. Validity and Reliability of the U.S. National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    PubMed Central

    Dueck, Amylou C.; Mendoza, Tito R.; Mitchell, Sandra A.; Reeve, Bryce B.; Castro, Kathleen M.; Rogak, Lauren J.; Atkinson, Thomas M.; Bennett, Antonia V.; Denicoff, Andrea M.; O'Mara, Ann M.; Li, Yuelin; Clauser, Steven B.; Bryant, Donna M.; Bearden, James D.; Gillis, Theresa A.; Harness, Jay K.; Siegel, Robert D.; Paul, Diane B.; Cleeland, Charles S.; Schrag, Deborah; Sloan, Jeff A.; Abernethy, Amy P.; Bruner, Deborah W.; Minasian, Lori M.; Basch, Ethan

    2016-01-01

    Importance Symptomatic adverse events (AEs) in cancer trials are currently reported by clinicians using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE). To integrate the patient perspective, the NCI developed a patient-reported outcomes version of the CTCAE (PRO-CTCAE) to capture symptomatic AEs directly from patients. Objective To assess the construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items. Design Participants completed PRO-CTCAE items on tablet computers in clinic waiting rooms at two visits 1-6 weeks apart. A subset completed PRO-CTCAE items during an additional visit one business day after the first visit. Setting Nine U.S. cancer centers and community oncology practices. Participants 975 adult cancer patients undergoing outpatient chemotherapy and/or radiation enrolled between January 2011 and February 2012. Eligibility required participants to read English and be without clinically significant cognitive impairment. Main Outcome(s) and Measure(s) Primary comparators were clinician-reported Eastern Cooperative Oncology Group Performance Status (ECOG PS) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30). Results 940/975 (96%) and 852/940 (91%) participants completed PRO-CTCAE items at each visit. 938/940 (99.8%) participants (53% female, median age 59, 32% high school education or less, 17% ECOG PS 2-4) reported having at least one symptom. All PRO-CTCAE items had at least one correlation in the expected direction with a QLQ-C30 scale (111/124 P<.05). Stronger correlations were seen between PRO-CTCAE items and conceptually-related QLQ-C30 domains. Scores for 94/124 PRO-CTCAE items were higher in the ECOG PS 2-4 versus 0-1 group (58/124 P<.05). Overall, 119/124 items met at least one construct validity criterion. Test-retest reliability was acceptable for 36/49 pre-specified items (median intra-class correlation coefficient

  17. Utility of the social communication questionnaire-current and social responsiveness scale as teacher-report screening tools for autism spectrum disorders.

    PubMed

    Schanding, G Thomas; Nowell, Kerri P; Goin-Kochel, Robin P

    2012-08-01

    Limited research exists regarding the role of teachers in screening for Autism Spectrum Disorders (ASD). The current study examined the use of the Social Communication Questionnaire (SCQ) and Social Responsiveness Scale (SRS) as completed by parents and teachers about school-age children from the Simons Simplex Collection. Using the recommended cutoff scores in the manuals and extant literature, the teacher-completed SCQ and SRS yielded lower sensitivity and specificity values than would be desirable; however, lowering the cutoff scores on both instruments improved sensitivity and specificity to more adequate levels for screening purposes. Using the adjusted cutoff scores, the SRS teacher form appears to be a slightly better screener than the SCQ. Implications and limitations are discussed, as well as areas for future research. PMID:22143742

  18. Pragmatic Characteristics of Patient-Reported Outcome Measures are Important for Use in Clinical Practice

    PubMed Central

    Kroenke, Kurt; Monahan, Patrick O.; Kean, Jacob

    2015-01-01

    Objective Measures for assessing patient-reported outcomes (PROs) that may have initially been developed for research are increasingly being recommended for use in clinical practice as well. While psychometric rigor is essential, this paper focuses on pragmatic characteristics of PROs that may enhance uptake into clinical practice. Methods Three sources were drawn upon in identifying pragmatic criteria for PROs: 1) selected literature review including recommendations by other expert groups; 2) key features of several model public domain PROs; 3) the author' experience in developing practical PROs. Results Eight characteristics of a practical PRO include: 1) actionability (i.e., scores guide diagnostic or therapeutic actions/decision-making); 2) appropriateness for the relevant clinical setting; 3) universality (i.e., for screening, severity assessment, and monitoring across multiple conditions); 4) self-administration; 5) item features (number of items and bundling issues); 6) response options (option number and dimensions, uniform vs. varying options, timeframe, intervals between options); 7) scoring (simplicity, interpretability); and 8) accessibility (nonproprietary, downloadable, available in different languages and for vulnerable groups, incorporated into electronic health records) Conclusion Balancing psychometric and pragmatic factors in the development of PROs is important for accelerating the incorporation of PROs into clinical practice. PMID:25962972

  19. 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

  20. 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. PMID:27059031

  1. Collecting Patient-Reported Outcomes: Lessons from the California Joint Replacement Registry

    PubMed Central

    Chenok, Kate; Teleki, Stephanie; SooHoo, Nelson F.; Huddleston, James; Bozic, Kevin J.

    2015-01-01

    Context: While patient-reported outcomes (PROs) have long been used for research, recent technology advancements make it easier to collect patient feedback and use it for patient care. Despite the promise and appeal of PROs, substantial barriers to widespread adoption remain—including challenges in interpreting privacy regulations, educating patients and physicians about the power that PRO collection can provide to patient-centered care. Case Description: This article describes lessons learned from the California Joint Replacement Registry’s (CJRR) five-year effort to collect PROs from patients undergoing total hip and total knee replacement surgeries. CJRR is a voluntary, multi-institutional registry in California that collects clinical and device information, as well as PROs from patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA) surgeries. Proposed Solutions: The CJRR encountered and developed solutions to overcome several key issues: (1) limitations of electronic PRO collection, (2) challenges in patient recruitment and tracking, (3) challenges in encouraging patients to complete PRO surveys, (4) real and perceived administrative burden to clinic and hospital staff, (5) surgeon engagement, and (6) survey costs. Conclusion: The CJRR’s field experience can inform growing numbers of providers and researchers who seek to more fully understand the impact of care from the patient’s perspective. In addition, the authors believe that these challenges can best be addressed through a combination of policy changes and increased incentives. PMID:26793737

  2. Using R and WinBUGS to fit a Generalized Partial Credit Model for developing and evaluating patient-reported outcomes assessments

    PubMed Central

    Li, Yuelin; Baser, Ray

    2013-01-01

    The US Food and Drug Administration recently announced the final guidelines on the development and validation of Patient-Reported Outcomes (PROs) assessments in drug labeling and clinical trials. This guidance paper may boost the demand for new PRO survey questionnaires. Henceforth biostatisticians may encounter psychometric methods more frequently, particularly Item Response Theory (IRT) models to guide the shortening of a PRO assessment instrument. This article aims to provide an introduction on the theory and practical analytic skills in fitting a Generalized Partial Credit Model in IRT (GPCM). GPCM theory is explained first, with special attention to a clearer exposition of the formal mathematics than what is typically available in the psychometric literature. Then a worked example is presented, using self-reported responses taken from the International Personality Item Pool. The worked example contains step-by-step guides on using the statistical languages R and WinBUGS in fitting the GPCM. Finally, the Fisher information function of the GPCM model is derived and used to evaluate, as an illustrative example, the usefulness of assessment items by their information contents. This article aims to encourage biostatisticians to apply IRT models in the re-analysis of existing data and in future research. PMID:22362655

  3. 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.

  4. 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

  5. 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

  6. 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…

  7. 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…

  8. 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,…

  9. 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…

  10. The Educational Context and Outcomes for High School Students with Disabilities: Overview of the Study and Findings. Research Report.

    ERIC Educational Resources Information Center

    Schumaker, Jean B.; Deshler, Donald D.; Lenz, B. Keith; Bulgren, Janis A.; Davis, Betsy; Grossen, Bonnie; Marquis, Janet

    This research report discusses findings from descriptive studies that investigated the context and outcomes of educational programs for students with disabilities who were expected to receive standard high-school diplomas. The nine high schools included three in urban areas, three in suburban areas, and three in rural areas. Principals, special…

  11. 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…

  12. The importance of patient-reported outcomes: a call for their comprehensive integration in cardiovascular clinical trials.

    PubMed

    Anker, Stefan D; Agewall, Stefan; Borggrefe, Martin; Calvert, Melanie; Jaime Caro, J; Cowie, Martin R; Ford, Ian; Paty, Jean A; Riley, Jillian P; Swedberg, Karl; Tavazzi, Luigi; Wiklund, Ingela; Kirchhof, Paulus

    2014-08-01

    Patient-reported outcomes (PROs), such as symptoms, health-related quality of life (HRQOL), or patient perceived health status, are reported directly by the patient and are powerful tools to inform patients, clinicians, and policy-makers about morbidity and 'patient suffering', especially in chronic diseases. Patient-reported outcomes provide information on the patient experience and can be the target of therapeutic intervention. Patient-reported outcomes can improve the quality of patient care by creating a holistic approach to clinical decision-making; however, PROs are not routinely used as key outcome measures in major cardiovascular clinical trials. Thus, limited information is available on the impact of cardiovascular therapeutics on PROs to guide patient-level clinical decision-making or policy-level decision-making. Cardiovascular clinical research should shift its focus to include PROs when evaluating the efficacy of therapeutic interventions, and PRO assessments should be scientifically rigorous. The European Society of Cardiology and other professional societies can take action to influence the uptake of PRO data in the research and clinical communities. This process of integrating PRO data into comprehensive efficacy evaluations will ultimately improve the quality of care for patients across the spectrum of cardiovascular disease.

  13. Assessing the Psychological Changes of Gifted Students Attending a Residential High School with an Outcome Measurement

    ERIC Educational Resources Information Center

    Rollins, Marlon R.; Cross, Tracy L.

    2014-01-01

    This study examined the psychological changes that 272 students experienced while attending a residential school for gifted adolescents in the Midwest. This article shares the quantitative portion of a mixed-methods study. Outcome measurement data from the Youth Outcome Questionnaire Self-Report 2.0 (YOQ-SR) tracked students' level of…

  14. Non-dystrophic myotonia: prospective study of objective and patient reported outcomes.

    PubMed

    Trivedi, Jaya R; Bundy, Brian; Statland, Jeffrey; Salajegheh, Mohammad; Rayan, Dipa Raja; Venance, Shannon L; Wang, Yunxia; Fialho, Doreen; Matthews, Emma; Cleland, James; Gorham, Nina; Herbelin, Laura; Cannon, Stephen; Amato, Anthony; Griggs, Robert C; Hanna, Michael G; Barohn, Richard J

    2013-07-01

    .6% of sodium channel participants, which increased post-cooling to 57.6% in sodium channel mutations. In evaluation of patients with clinical and electrical myotonia, despite considerable phenotypic overlap, the presence of eye closure myotonia, paradoxical myotonia, and an increase in short exercise test sensitivity post-cooling suggest sodium channel mutations. Outcomes designed to measure stiffness or the electrophysiological correlates of stiffness may prove useful for future clinical trials, regardless of underlying mutation, and include patient-reported stiffness, bedside manoeuvres to evaluate myotonia, muscle specific quality of life instruments and short exercise testing. PMID:23771340

  15. Non-dystrophic myotonia: prospective study of objective and patient reported outcomes

    PubMed Central

    Bundy, Brian; Statland, Jeffrey; Salajegheh, Mohammad; Rayan, Dipa Raja; Venance, Shannon L.; Wang, Yunxia; Fialho, Doreen; Matthews, Emma; Cleland, James; Gorham, Nina; Herbelin, Laura; Cannon, Stephen; Amato, Anthony; Griggs, Robert C.; Hanna, Michael G.; Barohn, Richard J.

    2013-01-01

    .6% of sodium channel participants, which increased post-cooling to 57.6% in sodium channel mutations. In evaluation of patients with clinical and electrical myotonia, despite considerable phenotypic overlap, the presence of eye closure myotonia, paradoxical myotonia, and an increase in short exercise test sensitivity post-cooling suggest sodium channel mutations. Outcomes designed to measure stiffness or the electrophysiological correlates of stiffness may prove useful for future clinical trials, regardless of underlying mutation, and include patient-reported stiffness, bedside manoeuvres to evaluate myotonia, muscle specific quality of life instruments and short exercise testing. PMID:23771340

  16. 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…

  17. 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…

  18. Ten Hypotheses about Socioeconomic Gradients and Community Differences in Children's Developmental Outcomes. Final Report

    ERIC Educational Resources Information Center

    Willms, J. Douglas

    2003-01-01

    The term "socioeconomic gradient" is often used to describe the relationships between social outcomes and socioeconomic status (SES) for individuals in a specific community. In research on child development the social outcome is typically a measure describing cognitive ability, health, behaviour, social skills, or personality traits. This paper…

  19. The Role of Outcome Conflict in Dual-Task Interference. ICS Report 8601.

    ERIC Educational Resources Information Center

    Navon, David; Miller, Jeff

    The traditional explanation for dual-task interference is that tasks compete for scarce processing resources. Another possible explanation is that the outcome of the processing required for one task conflicts with the processing required for the other task. To explore the contribution of outcome conflict to task interference, this paper describes…

  20. Post-diagnosis Cruciferous Vegetable Consumption and Breast Cancer Outcomes: a Report from the After Breast Cancer Pooling Project

    PubMed Central

    Nechuta, Sarah; Caan, Bette J.; Chen, Wendy Y.; Kwan, Marilyn L.; Lu, Wei; Cai, Hui; Poole, Elizabeth M.; Flatt, Shirley W.; Zheng, Wei; Pierce, John P.; Shu, Xiao Ou

    2013-01-01

    Cruciferous vegetables are a major source of glucosinolate-derived bioactive compounds such as isothiocyanates, which have been shown in animal and in vitro studies to inhibit cancer growth and progression. Few studies have investigated cruciferous vegetable intake after diagnosis and breast cancer outcomes. Using data from the After Breast Cancer Pooling Project, which includes prospective data from US and Chinese breast cancer survivors, we evaluated the association of cruciferous vegetables with breast cancer outcomes. Analyses included 11,390 women diagnosed with stage I–III invasive breast cancer (1990–2006) from four cohorts. Cruciferous vegetable intake (g/day) was assessed using food frequency questionnaires (mean of 22 months post-diagnosis). Study heterogeneity was evaluated by the Q statistic; hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated using delayed-entry Cox regression models stratified by study. After a median follow-up of 9.0 years, 1,725 deaths and 1,421 recurrences were documented. In pooled analyses using study-specific quartiles, cruciferous vegetable intake was not associated with breast cancer outcomes, adjusting for known clinical prognostic factors and selected lifestyle factors. HRs (95%CIs) by increasing quartiles (reference=lowest quartile) were 1.08 (0.93–1.25), 1.01 (0.87–1.18), and 1.10 (0.95–1.28) for recurrence (Ptrend=0.34) and 1.01 (0.88–1.15), 0.97 (0.84–1.11), and 0.99 (0.86–1.13) for total mortality (Ptrend=0.84). No associations were observed for subgroups defined by ER status, stage, or tamoxifen therapy. Cruciferous vegetable intake at approximately two years after diagnosis was not associated with recurrence or mortality. Our results do not support an association between post-diagnosis cruciferous vegetable intake and breast cancer outcomes. PMID:23765086

  1. The Impact of Waiting Time on Health Gains from Surgery: Evidence from a National Patient-reported Outcome Dataset.

    PubMed

    Nikolova, Silviya; Harrison, Mark; Sutton, Matt

    2016-08-01

    Reducing waiting times has been a major focus of the English National Health Service for many years, but little is known about the impact on health outcomes. The collection of data on patient-reported outcome measures for all patients undergoing four large-volume procedures facilitates analysis of the impact of waiting times on patient outcomes. The availability of patient-reported outcome measures before and after surgery allows us to estimate the impact of waiting times on the effectiveness of treatment, controlling for pre-surgery health and the endogeneity of waiting times caused by prioritisation with respect to pre-intervention health. We find that waiting time has a negative and statistically significant impact on the health gain from hip and knee replacement surgery and no impact on the effectiveness of varicose vein and hernia surgery. The magnitude of this effect at patient level is small, 0.1% of the outcome measure range for each additional week of waiting. However, the value of this effect is substantially larger than existing estimates of the disutility experienced during the waiting period. The health losses associated with an additional week of waiting for annual populations of hip and knee replacement patients are worth £11.1m and £11.5m, respectively. Copyright © 2015 John Wiley & Sons, Ltd. PMID:26013773

  2. The Impact of Waiting Time on Health Gains from Surgery: Evidence from a National Patient-reported Outcome Dataset.

    PubMed

    Nikolova, Silviya; Harrison, Mark; Sutton, Matt

    2016-08-01

    Reducing waiting times has been a major focus of the English National Health Service for many years, but little is known about the impact on health outcomes. The collection of data on patient-reported outcome measures for all patients undergoing four large-volume procedures facilitates analysis of the impact of waiting times on patient outcomes. The availability of patient-reported outcome measures before and after surgery allows us to estimate the impact of waiting times on the effectiveness of treatment, controlling for pre-surgery health and the endogeneity of waiting times caused by prioritisation with respect to pre-intervention health. We find that waiting time has a negative and statistically significant impact on the health gain from hip and knee replacement surgery and no impact on the effectiveness of varicose vein and hernia surgery. The magnitude of this effect at patient level is small, 0.1% of the outcome measure range for each additional week of waiting. However, the value of this effect is substantially larger than existing estimates of the disutility experienced during the waiting period. The health losses associated with an additional week of waiting for annual populations of hip and knee replacement patients are worth £11.1m and £11.5m, respectively. Copyright © 2015 John Wiley & Sons, Ltd.

  3. An investigation of outcome expectancies as a predictor of treatment response for combat veterans with PTSD: Comparison of clinician, self-report, and biological measures

    PubMed Central

    Price, Matthew; Maples, Jessica L.; Jovanovic, Tanja; Norrholm, Seth D.; Heekin, Mary; Rothbaum, Barbara O.

    2015-01-01

    Background Outcome expectancy, or the degree to which a client believes that therapy will result in improvement, is related to improved treatment outcomes for multiple disorders. There is a paucity of research investigating this relation in regards to PTSD. Additionally, the bulk of the research on outcome expectancy and treatment outcomes has relied mostly on self-report outcome measures. Methods The relation between outcome expectancy on self-report measures, clinician-rated measures, and two biological indices (fear potentiated startle and cortisol reactivity) of PTSD symptoms was explored. The sample included combat veterans (N= 116) treated with virtual reality exposure therapy for PTSD. Results Results supported a negative association between outcome expectancy and both self-report and clinician-rated symptoms at the conclusion of treatment, but outcome expectancy was related to the magnitude of change during treatment for self-report measures only. Outcome expectancy was unrelated to biological measures of treatment response. Conclusions These findings suggest that outcome expectancy may be related to patient and clinician perceptions of outcomes but not biological indices of outcome for PTSD. PMID:25703611

  4. Role of patient-reported outcomes and other efficacy endpoints in the drug approval process in Europe (2008-2012).

    PubMed

    Bansal, Dipika; Bhagat, Anil; Schifano, Fabrizio; Gudala, Kapil

    2015-12-01

    The present study aimed at systematically reviewing the role and extent of patient-reported outcomes (PROs) usage within the package of scientific evidence considered for marketing authorization (MA). All regulatory information published by the European Medicines Agency (EMA) for products authorized between January 2008 and December 2012 and appearing in the European Public Assessment Report (EPAR) database was examined for efficacy endpoints. The endpoints here considered included: PROs, clinician reported outcomes (CROs), and laboratory reported outcomes (LROs). LROs were the most frequently reported endpoints. Out of the 180 products here selected, 99 (55%), 67 (37%), and 30 (17%), respectively, used LROs, CROs and PROs as primary endpoints (PEs). PROs as any endpoints were used in 82 (46%) products. Out of these, PROs were documented as PE in 30 (37%), with 27 (33%) products having used PROs both as primary and non-PEs. PRO usage was most frequently identified with nervous system and antineoplastic agents. During the study period, the use of all the three types of endpoints appeared to be static. Both the regulatory bodies and the industry should ensure complete and clear reporting of all endpoints used, including PROs, to improve transparency. PMID:26031612

  5. Adjunctive naturopathic care for type 2 diabetes: patient-reported and clinical outcomes after one year

    PubMed Central

    2012-01-01

    Background Several small, uncontrolled studies have found improvements in self-care behaviors and reductions in clinical risk in persons with type 2 diabetes who received care from licensed naturopathic physicians. To extend these findings and determine the feasibility and promise of a randomized clinical trial, we conducted a prospective study to measure the effects of adjunctive naturopathic care (ANC) in primary care patients with inadequately controlled type 2 diabetes. Methods Forty patients with type 2 diabetes were invited from a large integrated health care system to receive up to eight ANC visits for up to one year. Participants were required to have hemoglobin A1c (HbA1c) values between 7.5-9.5 % and at least one additional cardiovascular risk factor (i.e., hypertension, hyperlipidemia or overweight). Standardized instruments were administered by telephone to collect outcome data on self-care, self-efficacy, diabetes problem areas, perceived stress, motivation, and mood. Changes from baseline scores were calculated at 6- and 12-months after entry into the study. Six and 12-month changes in clinical risk factors (i.e., HbA1c, lipid and blood pressure) were calculated for the ANC cohort, and compared to changes in a cohort of 329 eligible, non-participating patients constructed using electronic medical records data. Between-cohort comparisons were adjusted for age, gender, baseline HbA1c, and diabetes medications. Six months was pre-specified as the primary endpoint for outcome assessment. Results Participants made 3.9 ANC visits on average during the year, 78 % of which occurred within six months of entry into the study. At 6-months, significant improvements were found in most patient-reported measures, including glucose testing (P = 0.001), diet (P = 0.001), physical activity (P = 0.02), mood (P = 0.001), self-efficacy (P = 0.0001) and motivation to change lifestyle (P = 0.003). Improvements in glucose testing, mood, self-efficacy and motivation to change

  6. Current Status, Goals, and Research Agenda for Outcome Measures Development in Behçet Syndrome: Report from OMERACT 2014

    PubMed Central

    Hatemi, Gulen; Ozguler, Yesim; Direskeneli, Haner; Mahr, Alfred; Gul, Ahmet; Levi, Virna; Aydin, Sibel Z.; Mumcu, Gonca; Sertel-Berk, Ozlem; Stevens, Randall M.; Yazici, Hasan; Merkel, Peter A.

    2016-01-01

    Objective There is an unmet need for reliable, validated, and widely accepted outcomes and outcome measures for use in clinical trials in Behçet syndrome (BS). Our report summarizes initial steps taken by the Outcome Measures in Rheumatology (OMERACT) vasculitis working group toward developing a core set of outcome measures for BS according to the OMERACT methodology, including the OMERACT Filter 2.0, and discussions during the first meeting of the BS working group held during OMERACT 12 (2014). Methods During OMERACT 12, some of the important challenges in developing outcomes for BS were outlined and discussed, and a research agenda was drafted. Results Among topics discussed were the advantages and disadvantages of a composite measure for BS that evaluates several organs/organ systems; bringing patients and physicians together for discussions about how to assess disease activity; use of organ-specific measures developed for other diseases; and the inclusion of generic, disease-specific, or organ-specific measures. The importance of incorporating patients’ perspectives, concerns, and ideas into outcome measure development was emphasized. Conclusion The planned research agenda includes conducting a Delphi exercise among physicians from different specialties that are involved in the care of patients with BS and among patients with BS, with the aim of identifying candidate domains and subdomains to be assessed in randomized clinical trials of BS, and candidate items for a composite measure. The ultimate goal of the group is to develop a validated and widely accepted core set of outcomes and outcome measures for use in clinical trials in BS. PMID:26373563

  7. Early rehabilitation affects functional outcomes and activities of daily living after arthroscopic rotator cuff repair: a case report

    PubMed Central

    Shimo, Satoshi; Sakamoto, Yuta; Tokiyoshi, Akinari; Yamamoto, Yasuhiro

    2016-01-01

    [Purpose] The effect of early rehabilitation protocols after arthroscopic rotator cuff repair is currently unknown. We examined short-term effects of early rehabilitation on functional outcomes and activities of daily living after arthroscopic rotator cuff repair. [Subject and Methods] An 82-year-old male fell during a walk, resulting in a supraspinatus tear. Arthroscopic rotator cuff repair was performed using a single-row technique. He wore an abduction brace for 6 weeks after surgery. [Results] From day 1 after surgery, passive range of motion exercises, including forward flexion and internal and external rotation were performed twice per day. Starting at 6 weeks after surgery, active range of motion exercises and muscle strengthening exercises were introduced gradually. At 6 weeks after surgery, his active forward flexion was 150°, UCLA shoulder rating scale score was 34 points, and Quick Disabilities of the Arm, Shoulder, and Hand questionnaire disability/symptom score was 36 points. At 20 weeks after surgery, his active forward flexion was 120°, UCLA shoulder rating scale score was 34 points, and Quick Disabilities of the Arm, Shoulder, and Hand questionnaire disability/symptom score was 0 points. [Conclusion] These protocols are recommended to physical therapists during rehabilitation for arthroscopic rotator cuff repair to support rapid reintegration into activities of daily living. PMID:27064886

  8. Early rehabilitation affects functional outcomes and activities of daily living after arthroscopic rotator cuff repair: a case report.

    PubMed

    Shimo, Satoshi; Sakamoto, Yuta; Tokiyoshi, Akinari; Yamamoto, Yasuhiro

    2016-01-01

    [Purpose] The effect of early rehabilitation protocols after arthroscopic rotator cuff repair is currently unknown. We examined short-term effects of early rehabilitation on functional outcomes and activities of daily living after arthroscopic rotator cuff repair. [Subject and Methods] An 82-year-old male fell during a walk, resulting in a supraspinatus tear. Arthroscopic rotator cuff repair was performed using a single-row technique. He wore an abduction brace for 6 weeks after surgery. [Results] From day 1 after surgery, passive range of motion exercises, including forward flexion and internal and external rotation were performed twice per day. Starting at 6 weeks after surgery, active range of motion exercises and muscle strengthening exercises were introduced gradually. At 6 weeks after surgery, his active forward flexion was 150°, UCLA shoulder rating scale score was 34 points, and Quick Disabilities of the Arm, Shoulder, and Hand questionnaire disability/symptom score was 36 points. At 20 weeks after surgery, his active forward flexion was 120°, UCLA shoulder rating scale score was 34 points, and Quick Disabilities of the Arm, Shoulder, and Hand questionnaire disability/symptom score was 0 points. [Conclusion] These protocols are recommended to physical therapists during rehabilitation for arthroscopic rotator cuff repair to support rapid reintegration into activities of daily living. PMID:27064886

  9. 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

    2013-01-01

    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 global collaboration, PROMIS has the potential to transform PRO measurement by creating a shared, unifying terminology and metric for reporting of common symptoms and functional life domains. Extending a common set of standardized PRO measures to the international community offers great potential for improving patient-centered research, clinical trials reporting, population monitoring, and health care worldwide. Benefits of such standardization include the possibility of: international syntheses (such as meta-analyses) of research findings; international population monitoring and policy development; health services administrators and planners access to relevant information on the populations they serve; better assessment and monitoring of patients by providers; and improved shared decision making.The goal of the current PROMIS International initiative is to ensure that item banks are translated and culturally adapted for use in adults and children in as many countries as possible. The process includes 3 key steps: translation/cultural adaptation, calibration, and validation. A universal translation, an approach focusing on commonalities, rather than differences across versions developed in regions or countries speaking the same language, is proposed to ensure conceptual equivalence for all items. International item

  10. Questionnaire Surveys: Four Survey Instruments in Educational Research.

    ERIC Educational Resources Information Center

    Inoue, Yukiko

    This paper presents four questionnaire surveys administered in educational research. Each of the questionnaires is followed by a brief research report with an abstract and summary statistics. The first survey, "Guam Undergraduate Women Questionnaire," explores the status aspiration and gender awareness of undergraduate women in Guam. Responses of…

  11. Self-reported rates of interpersonal conflict vary as a function of questionnaire format: why age-related trends in disagreement (and other events) may not be what they seem.

    PubMed

    Dirghangi, Shrija; Laursen, Brett; Puder, Justin; Bjorklund, David F; DeLay, Dawn

    2014-10-01

    Two studies examine whether self-reports of interpersonal conflict differ as a function of how the question is asked. In Study 1, 56 U.S. college students (M = 20.7 years) completed different versions of a questionnaire, four times, at one week intervals. Participants reported more conflicts with the aid of memory prompts than without, an effect that was especially strong when questions focused on events from the previous day. In Study 2, 123 middle-school students (M = 11.08 years) and 128 primary school students (M = 8.2 years) from the same region completed one of two questionnaires describing conflict during the previous day. Children reported more conflicts with memory prompts than without. The effect was twice as strong for younger children than older children. The findings suggest that increases in reports of conflict across the transition into adolescence may be due to improvements in the ability to recall and recount events in the absence of memory cues.

  12. Disentangling the Impact of Artistic Creativity on Creative Thinking, Working Memory, Attention, and Intelligence: Evidence for Domain-Specific Relationships with a New Self-Report Questionnaire

    PubMed Central

    Lunke, Katrin; Meier, Beat

    2016-01-01

    The goal of the present study was to take a new look at the relationship between creativity and cognitive functioning. Based on models that have postulated domain- and sub-domain-structures for different forms of creativity, like scientific, technical or artistic creativity with cognitive functions as important basis, we developed a new questionnaire. The Artistic Creativity Domains Compendium (ACDC) assesses interest, ability and performance in a distinct way for different domains of artistic creativity. We present the data of 270 adults tested with the ACDC, standard tests of divergent and convergent thinking, and tests of cognitive functions. We present fine-grained analyses on the internal and external validity of the ACDC and on the relationships between creativity, working memory, attention, and intelligence. Our results indicate domain-specific associations between creativity and attention as well as working memory. We conclude that the ACDC is a valid instrument to assess artistic creativity and that a fine-grained analysis reveals distinct patterns of relationships between separate domains of creativity and cognition. PMID:27516745

  13. Disentangling the Impact of Artistic Creativity on Creative Thinking, Working Memory, Attention, and Intelligence: Evidence for Domain-Specific Relationships with a New Self-Report Questionnaire.

    PubMed

    Lunke, Katrin; Meier, Beat

    2016-01-01

    The goal of the present study was to take a new look at the relationship between creativity and cognitive functioning. Based on models that have postulated domain- and sub-domain-structures for different forms of creativity, like scientific, technical or artistic creativity with cognitive functions as important basis, we developed a new questionnaire. The Artistic Creativity Domains Compendium (ACDC) assesses interest, ability and performance in a distinct way for different domains of artistic creativity. We present the data of 270 adults tested with the ACDC, standard tests of divergent and convergent thinking, and tests of cognitive functions. We present fine-grained analyses on the internal and external validity of the ACDC and on the relationships between creativity, working memory, attention, and intelligence. Our results indicate domain-specific associations between creativity and attention as well as working memory. We conclude that the ACDC is a valid instrument to assess artistic creativity and that a fine-grained analysis reveals distinct patterns of relationships between separate domains of creativity and cognition. PMID:27516745

  14. Disentangling the Impact of Artistic Creativity on Creative Thinking, Working Memory, Attention, and Intelligence: Evidence for Domain-Specific Relationships with a New Self-Report Questionnaire.

    PubMed

    Lunke, Katrin; Meier, Beat

    2016-01-01

    The goal of the present study was to take a new look at the relationship between creativity and cognitive functioning. Based on models that have postulated domain- and sub-domain-structures for different forms of creativity, like scientific, technical or artistic creativity with cognitive functions as important basis, we developed a new questionnaire. The Artistic Creativity Domains Compendium (ACDC) assesses interest, ability and performance in a distinct way for different domains of artistic creativity. We present the data of 270 adults tested with the ACDC, standard tests of divergent and convergent thinking, and tests of cognitive functions. We present fine-grained analyses on the internal and external validity of the ACDC and on the relationships between creativity, working memory, attention, and intelligence. Our results indicate domain-specific associations between creativity and attention as well as working memory. We conclude that the ACDC is a valid instrument to assess artistic creativity and that a fine-grained analysis reveals distinct patterns of relationships between separate domains of creativity and cognition.

  15. Diet History Questionnaire: Suggested Citations

    Cancer.gov

    Use of the Diet History Questionnaire and Diet*Calc Analysis Software for publication purposes should contain a citation which includes version information for the software, questionnaire, and nutrient database.

  16. Diet History Questionnaire: International Applications

    Cancer.gov

    ARP staff adapted the Diet History Questionnaire (DHQ) for use by Canadian populations in collaboration with the Alberta Cancer Board. This questionnaire takes into account the different food fortification polices of the U.S. and Canada.

  17. Composite scores in comparative effectiveness research: counterbalancing parsimony and dimensionality in patient-reported outcomes.

    PubMed

    Schwartz, Carolyn E; Patrick, Donald L

    2014-07-01

    When planning a comparative effectiveness study comparing disease-modifying treatments, competing demands influence choice of outcomes. Current practice emphasizes parsimony, although understanding multidimensional treatment impact can help to personalize medical decision-making. We discuss both sides of this 'tug of war'. We discuss the assumptions, advantages and drawbacks of composite scores and multidimensional outcomes. We describe possible solutions to the multiple comparison problem, including conceptual hierarchy distinctions, statistical approaches, 'real-world' benchmarks of effectiveness and subgroup analysis. We conclude that comparative effectiveness research should consider multiple outcome dimensions and compare different approaches that fit the individual context of study objectives.

  18. Current Trends in the Use of Patient-Reported Outcome Instruments in Degenerative Cervical Spine Surgery

    PubMed Central

    Ueda, Haruki; Cutler, Holt S.; Guzman, Javier Z.; Cho, Samuel K.

    2015-01-01

    Study Design Bibliometric analysis. Objective To determine trends, frequency, and distribution of patient-reported outcome instruments (PROIs) in degenerative cervical spine surgery literature over the past decade. Methods A search was conducted via PubMed from 2004 to 2013 on five journals (The Journal of Bone and Joint Surgery, The Bone and Joint Journal, The Spine Journal, European Spine Journal, and Spine), which were chosen based on their impact factors and authors' consensus. All abstracts were screened and articles addressing degenerative cervical spine surgery using PROIs were included. Articles were then analyzed for publication date, study design, journal, level of evidence, and PROI trends. Prevalence of PROIs and level of evidence of included articles were analyzed. Results From 19,736 articles published, 241 articles fulfilled our study criteria. Overall, 53 distinct PROIs appeared. The top seven most frequently used PROIs were: Japanese Orthopaedic Association score (104 studies), visual analog scale for pain (100), Neck Disability Index (72), Short Form-36 (38), Nurick score (25), Odom criteria (21), and Oswestry Disability Index (15). Only 11 PROIs were used in 5 or more articles. Thirty-three of the PROIs were appeared in only 1 article. Among the included articles, 16% were of level 1 evidence and 32% were of level 4 evidence. Conclusion Numerous PROIs are currently used in degenerative cervical spine surgery. A consensus on which instruments to use for a given diagnosis or procedure is lacking and may be necessary for better communication and comparison, as well as for the accumulation and analysis of vast clinical data across multiple studies. PMID:27099815

  19. Communicating the results of randomized clinical trials: do patients understand multidimensional patient-reported outcomes?

    PubMed

    McNair, Angus G K; Brookes, Sara T; Davis, Christopher R; Argyropoulos, Miltiadis; Blazeby, Jane M

    2010-02-10

    PURPOSE Evidence suggests that patient-reported outcomes (PROs) from randomized trials in oncology may not influence clinical decision making and patient choice. Reasons for this are currently unclear and little is known about patients' interpretation of PROs. This study assessed patients' understanding of multidimensional PROs in a graphical format. PATIENTS AND METHODS Semistructured interviews in which patients interpreted a series of graphs depicting simple, then multiple different hypothetical PROs associated with two treatments with identical chances of survival were audio recorded. The interviewer and a blinded observer (listening to audio recordings) scored patients' understanding of the graphs. Logistic regression examined the associations between patient understanding of the graphs and clinical and sociodemographic details. Results One hundred thirty-two patients with esophageal and gastric cancer were interviewed and 115 understood the first two graphs depicting different PROs of two treatments (87%; 95% CI,81 to 93). Simultaneous interpretation of adverse and beneficial treatment effects was achieved by 74 (66%; 95% CI, 57 to 75). Graphs showing complex, longitudinal data were correctly interpreted by 97 (73%; 95% CI, 66 to 81) and 108 (81%; 95% CI, 75 to 88), respectively. Univariable analyses demonstrated associations between patient understanding and patient age, educational level, and cancer site (P < or = .02 for all); however, in a multivariable model each of these associations was attenuated. CONCLUSION Most patients understand graphical multidimensional PROs, although a smaller majority were able to interpret more complex, or simultaneous, presentations. Additional work is needed to define methods for communicating clinical and PRO data from trials to allow patients to make informed treatment choices. PMID:20065187

  20. Australian Group on Antimicrobial Resistance Australian Enterococcal Sepsis Outcome Programme annual report, 2014.

    PubMed

    Coombs, Geoffrey W; Daley, Denise A; Thin Lee, Yung; Pang, Stanley; Pearson, Julie C; Robinson, J Owen; Johnson, Paul Dr; Kotsanas, Despina; Bell, Jan M; Turnidge, John D

    2016-01-01

    From 1 January to 31 December 2014, 27 institutions around Australia participated in the Australian Enterococcal Sepsis Outcome Programme (AESOP). The aim of AESOP 2014 was to determine the proportion of enterococcal bacteraemia isolates in Australia that were antimicrobial resistant, and to characterise the molecular epidemiology of the Enterococcus faecium isolates. Of the 952 unique episodes of bacteraemia investigated, 94.4% were caused by either E. faecalis (54.9%) or E. faecium (39.9%). Ampicillin resistance was detected in 0.6% of E. faecalis and in 89.4% of E. faecium. Vancomycin non-susceptibility was reported in 0.2% and 46.1% of E. faecalis and E. faecium respectively. Overall 51.1% of E. faecium harboured vanA or vanB genes. For the vanA/B positive E. faecium isolates, 81.5% harboured vanB genes and 18.5% vanA 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 consisted of 113 pulsed-field gel electrophoresis pulsotypes of which 68.9% of isolates were classified into 14 major pulsotypes containing 5 or more isolates. Multilocus sequence typing grouped the 14 major pulsotypes into clonal cluster 17, a major hospital-adapted polyclonal E. faecium cluster. The geographical distribution of the 4 predominant sequence types (ST203, ST796, ST555 and ST17) varied with only ST203 identified across most regions of Australia. Overall 74.7% of isolates belonging to the four predominant STs harboured vanA or vanB genes. In conclusion, the AESOP 2014 has shown enterococcal bacteraemias in Australia are frequently caused by polyclonal ampicillin-resistant high-level gentamicin resistant vanA or vanB E. faecium, which have limited treatment options. PMID:27522135

  1. Wechsler Adult Intelligence Scale-Third Edition profiles and their relationship to self-reported outcome following traumatic brain injury.

    PubMed

    Harman-Smith, Yasmin E; Mathias, Jane L; Bowden, Stephen C; Rosenfeld, Jeffrey V; Bigler, Erin D

    2013-01-01

    Neuropsychological assessments of outcome after traumatic brain injury (TBI) are often unrelated to self-reported problems after TBI. The current study cluster-analyzed the Wechsler Adult Intelligence Scale-Third Edition (WAIS-III) subtest scores from mild, moderate, and severe TBI (n=220) and orthopedic injury control (n=95) groups, to determine whether specific cognitive profiles are related to people's perceived outcomes after TBI. A two-stage cluster analysis produced 4- and 6-cluster solutions, with the 6-cluster solution better capturing subtle variations in cognitive functioning. The 6 clusters differed in the levels and profiles of cognitive performance, self-reported recovery, and education and injury severity. The findings suggest that subtle cognitive impairments after TBI should be interpreted in conjunction with patient's self-reported problems.

  2. The Interdependence and Determinants of Childhood Outcomes: The Relevance for Policy. Report to the Department of Children, Schools and Families. CEE Special Report 003

    ERIC Educational Resources Information Center

    Nasim, Bilal

    2010-01-01

    The Centre for the Economics of Education was asked to bring together a wide range of academic evidence (primarily England-based) to investigate the extent to which academic and non-academic childhood outcomes are complementary to each other, or are in some way traded-off against each other. The report also investigates the drivers of both…

  3. Assessment of the reporting of quality and outcome measures in hepatic resections: a call for 90-day reporting in all hepatectomy series

    PubMed Central

    Egger, Michael E; Ohlendorf, Joanna M; Scoggins, Charles R; McMasters, Kelly M; Martin, Robert C G

    2015-01-01

    Background The aim of this paper is to assess the current state of quality and outcomes measures being reported for hepatic resections in the recent literature. Methods Medline and PubMed databases were searched for English language articles published between 1 January 2002 and 30 April 2013. Two examiners reviewed each article and relevant citations for appropriateness of inclusion, which excluded papers of liver donor hepatic resections, repeat hepatectomies or meta-analyses. Data were extracted and summarized by two examiners for analysis. Results Fifty-five studies were identified with suitable reporting to assess peri-operative mortality in hepatic resections. In only 35% (19/55) of the studies was the follow-up time explicitly stated, and in 47% (26/55) of studies peri-operative mortality was limited to in-hospital or 30 days. The time period in which complications were captured was not explicitly stated in 19 out of 28 studies. The remaining studies only captured complications within 30 days of the index operation (8/28). There was a paucity of quality literature addressing truly patient-centred outcomes. Conclusion Quality outcomes after a hepatic resection are inconsistently reported in the literature. Quality outcome studies for a hepatectomy should report mortality and morbidity at a minimum of 90 days after surgery. PMID:26228262

  4. Acute primary meningoencephalitis from entamoeba Naegleria Fowleri. Report of a clinical case with a favourable outcome.

    PubMed

    Loschiavo, F; Ventura-Spagnolo, T; Sessa, E; Bramanti, P

    1993-10-01

    The Authors describe a primary amoebic acute meningoencephalitis case from Naegleria Fowleri, where the parasite was found in the cerebrospinal fluid and in culture. The case had a favorable outcome after treatment with amphotericin B.

  5. Agreement between prospective diary data and retrospective questionnaire report of abdominal pain and stooling symptoms in children with irritable bowel syndrome

    Technology Transfer Automated Retrieval System (TEKTRAN)

    In functional gastrointestinal disorders, patient recall of symptoms drives diagnostic decisions and evaluation of treatment response, and research conclusions about potential treatments. In pediatrics, parent report also impacts assessment and care. Hence, identifying methods for accurately capturi...

  6. The Context Dependency of the Self-Report Version of the Strength and Difficulties Questionnaire (SDQ): A Cross-Sectional Study between Two Administration Settings

    PubMed Central

    Hoofs, H.; Jansen, N. W. H.; Mohren, D. C. L.; Jansen, M. W. J.; Kant, I. J.

    2015-01-01

    Background The Strength and Difficulties Questionnaire (SDQ) is a screening instrument for psychosocial problems in children and adolescents, which is applied in “individual” and “collective” settings. Assessment in the individual setting is confidential for clinical applications, such as preventive child healthcare, while assessment in the collective setting is anonymous and applied in (epidemiological) research. Due to administration differences between the settings it remains unclear whether results and conclusions actually can be used interchangeably. This study therefore aims to investigate whether the SDQ is invariant across settings. Methods Two independent samples were retrieved (mean age = 14.07 years), one from an individual setting (N = 6,594) and one from a collective setting (N = 4,613). The SDQ was administered in the second year of secondary school in both settings. Samples come from the same socio-geographic population in the Netherlands. Results Confirmatory factor analysis showed that the SDQ was measurement invariant/equivalent across settings and gender. On average, children in the individual setting scored lower on total difficulties (mean difference = 2.05) and the psychosocial problems subscales compared to th