Sample records for reported outcome questionnaires

  1. The Patient Reported Outcomes, Burdens and Experiences (PROBE) Project: development and evaluation of a questionnaire assessing patient reported outcomes in people with haemophilia.

    PubMed

    Skinner, M W; Chai-Adisaksopha, C; Curtis, R; Frick, N; Nichol, M; Noone, D; O'Mahony, B; Page, D; Stonebraker, J S; Iorio, A

    2018-01-01

    The interest of health care agencies, private payers and policy makers for patient-reported outcomes (PRO) is continuously increasing. There is a substantial need to improve capacity to collect and interpret relevant PRO data to support implementation of patient-centered research and optimal care in haemophilia. The Patient Reported Outcomes, Burdens and Experiences (PROBE) Project aims to develop a patient-led research network, to develop a standardized questionnaire to gather patient-reported outcomes and to perform a feasibility study of implementing the PROBE questionnaire. A pilot questionnaire was developed using focus group methodology. Content and face validity were assessed by a pool of persons living with haemophilia (PWH) and content experts through interactive workshops. The PROBE questionnaire was translated with the forward-backward approach. PROBE recruited national haemophilia patient non-governmental organizations (NGOs) to administer the questionnaire to people with and without haemophilia. PROBE measured the time to complete the questionnaire and gathered feedback on its content and clarity; staff time and cost required to implement the questionnaire were also collected. The PROBE questionnaire is comprised of four major sections (demographic data, general health problems, haemophilia-related health problems and health-related quality of life using EQ-5D-5L and EQ-VAS). Seventeen NGOs participated in the pilot study of the PROBE Project, recruiting 656 participants. Of these, 71% completed the questionnaire within 15 min, and all participants completed within 30 min. The median total staff and volunteer time required for the NGOs to carry out the study within their country was 9 h (range 2 to 40 h). NGO costs ranged from $22.00 to $543.00 USD per country, with printing and postage being the most commonly reported expenditures. The PROBE questionnaire assesses patient-important reported outcomes in PWH and control participants, with a

  2. Late response to patient-reported outcome questionnaires after surgery was associated with worse outcome.

    PubMed

    Hutchings, Andrew; Grosse Frie, Kirstin; Neuburger, Jenny; van der Meulen, Jan; Black, Nick

    2013-02-01

    Nonresponse to patient-reported outcome (PRO) questionnaires after surgery might bias the results. Our aim was to gauge the potential impact of nonresponse bias by comparing the outcomes of early and late responders. This study compares 59,565 early and 20,735 late responders who underwent a hip or knee replacement, hernia repair, or varicose vein (VV) surgery. The association between timeliness of response and three outcomes (the mean postoperative disease-specific PRO and generic PRO scores and the proportion reporting a fair or poor result) was examined by regression analysis. Late responders were slightly more likely to be young, nonwhite, deprived, and have a more severe preoperative condition with poorer quality of life. Late response was associated with a slightly poorer outcome in all four procedures although not statistically significant (P < 0.05) for VV surgery. Adjusting for preoperative characteristics reduced the strength of the associations, but they remained statistically significant. As nonresponse to PRO questionnaires introduces slight bias, differences in response rates between hospitals should be taken into account when making comparisons so as to avoid overestimating the performance of those with lower response rates and failing to detect poor performing hospitals. Copyright © 2013 Elsevier Inc. All rights reserved.

  3. Patient-Reported Outcome questionnaires for hip arthroscopy: a systematic review of the psychometric evidence

    PubMed Central

    2011-01-01

    Background Hip arthroscopies are often used in the treatment of intra-articular hip injuries. Patient-reported outcomes (PRO) are an important parameter in evaluating treatment. It is unclear which PRO questionnaires are specifically available for hip arthroscopy patients. The aim of this systematic review was to investigate which PRO questionnaires are valid and reliable in the evaluation of patients undergoing hip arthroscopy. Methods A search was conducted in Pubmed, Medline, CINAHL, the Cochrane Library, Pedro, EMBASE and Web of Science from 1931 to October 2010. Studies assessing the quality of PRO questionnaires in the evaluation of patients undergoing hip arthroscopy were included. The quality of the questionnaires was evaluated by the psychometric properties of the outcome measures. The quality of the articles investigating the questionnaires was assessed by the COSMIN list. Results Five articles identified three questionnaires; the Modified Harris Hip Score (MHHS), the Nonarthritic Hip Score (NAHS) and the Hip Outcome Score (HOS). The NAHS scored best on the content validity, whereas the HOS scored best on agreement, internal consistency, reliability and responsiveness. The quality of the articles describing the HOS scored highest. The NAHS is the best quality questionnaire. The articles describing the HOS are the best quality articles. Conclusions This systematic review shows that there is no conclusive evidence for the use of a single patient-reported outcome questionnaire in the evaluation of patients undergoing hip arthroscopy. Based on available psychometric evidence we recommend using a combination of the NAHS and the HOS for patients undergoing hip arthroscopy. PMID:21619610

  4. Which is the most useful patient-reported outcome in femoroacetabular impingement? Test-retest reliability of six questionnaires.

    PubMed

    Hinman, Rana S; Dobson, Fiona; Takla, Amir; O'Donnell, John; Bennell, Kim L

    2014-03-01

    The most reliable patient-reported outcomes (PROs) for people with femoroacetabular impingement (FAI) is unknown because there have been no direct comparisons of questionnaires. Thus, the aim was to evaluate the test-retest reliability of six existing PROs in a single cohort of young active people with hip/groin pain consistent with a clinical diagnosis of FAI. Young adults with clinical FAI completed six PRO questionnaires on two occasions, 1-2 weeks apart. The PROs were modified Harris Hip Score, Hip dysfunction and Osteoarthritis Score, Hip Outcome Score, Non-Arthritic Hip Score, International Hip Outcome Tool, Copenhagen Hip and Groin Outcome Score. 30 young adults (mean age 24 years, SD 4 years, range 18-30 years; 15 men) with stable symptoms participated. Intraclass correlation coefficient(3,1) values ranged from 0.73 to 0.93 (95% CI 0.38 to 0.98) indicating that most questionnaires reached minimal reliability benchmarks. Measurement error at the individual level was quite large for most questionnaires (minimal detectable change (MDC95) 12.4-35.6, 95% CI 8.7 to 54.0). In contrast, measurement error at the group level was quite small for most questionnaires (MDC95 2.2-7.3, 95% CI 1.6 to 11). The majority of the questionnaires were reliable and precise enough for use at the group level. Samples of only 23-30 individuals were required to achieve acceptable measurement variation at the group level. Further direct comparisons of these questionnaires are required to assess other measurement properties such as validity, responsiveness and meaningful change in young people with FAI.

  5. Detecting Careless Responses to Self-Reported Questionnaires

    ERIC Educational Resources Information Center

    Kountur, Ronny

    2016-01-01

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

  6. Patient-reported outcome (PRO) questionnaires for men who have radical surgery for prostate cancer: a conceptual review of existing instruments.

    PubMed

    Protopapa, Evangelia; van der Meulen, Jan; Moore, Caroline M; Smith, Sarah C

    2017-10-01

    To critically review conceptual frameworks for available patient-reported outcome (PRO) questionnaires in men having radical prostatectomy (RP), psychometrically evaluate each questionnaire, and identify whether each is appropriate for use at the level of the individual patient. We searched PubMed, the Reports and Publications database of the University of Oxford Patient-Reported Outcomes Measurement Group and the website of the International Consortium for Health Outcomes Measurement (ICHOM) for psychometric reviews of prostate cancer-specific PRO questionnaires. From these we identified relevant questionnaires and critically appraised the conceptual content, guided by the Wilson and Cleary framework and psychometric properties, using well established criteria. The searches found four reviews and one recommendation paper. We identified seven prostate cancer-specific PROs: the Expanded Prostate Cancer Index Composite-26 (EPIC-26), Expanded Prostate Cancer Index Composite-50 (EPIC-50), University of California-Los Angeles Prostate Cancer Index (UCLA-PCI), Functional Assessment of Cancer Therapy - Prostate Cancer Subscale (FACT-P PCS), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - prostate specific 25-item (EORTC QLQ-PR25), Prostate Cancer - Quality of Life (PC-QoL), and Symptom Tracking and Reporting (STAR). Six out of seven measures purported to measure health-related quality of life (HRQL), but items focused strongly on urinary and sexual symptoms/functioning. The remaining questionnaire (STAR) claimed to assess functional recovery after RP. The psychometric evidence for these questionnaires was incomplete and variable in quality; none had evidence that they were appropriate for use with individual patients. Several questionnaires provide the basis of measures of urinary and/or sexual symptoms/functioning. Further work should explore other aspects of HRQL that are important for men having RP. Further psychometric work

  7. Primary Care Outcomes Questionnaire: psychometric testing of a new instrument.

    PubMed

    Murphy, Mairead; Hollinghurst, Sandra; Cowlishaw, Sean; Salisbury, Chris

    2018-06-01

    Patients attend primary care for many reasons and to achieve a range of possible outcomes. There is currently no Patient Reported Outcome Measure (PROM) designed to capture these diverse outcomes, and trials of interventions in primary care may thus fail to detect beneficial effects. This study describes the psychometric testing of the Primary Care Outcomes Questionnaire (PCOQ), which was designed to capture a broad range of outcomes relevant to primary care. Questionnaires were administered in primary care in South West England. Patients completed the PCOQ in GP waiting rooms before a consultation, and a second questionnaire, including the PCOQ and seven comparator PROMs, after 1 week. Psychometric testing included exploratory factor analysis on the PCOQ, internal consistency, correlation coefficients between domain scores and comparator measures, and repeated measures effect sizes indicating change across 1 week. In total, 602 patients completed the PCOQ at baseline, and 264 (44%) returned the follow-up questionnaire. Exploratory factor analysis suggested four dimensions underlying the PCOQ items: health and wellbeing, health knowledge and self-care, confidence in health provision, and confidence in health plan. Each dimension was internally consistent and correlated as expected with comparator PROMs, providing evidence of construct validity. Patients reporting an improvement in their main problem exhibited small to moderate improvements in relevant domain scores on the PCOQ. The PCOQ was acceptable, feasible, showed strong psychometric properties, and was responsive to change. It is a promising new tool for assessment of outcomes of primary care interventions from a patient perspective. © British Journal of General Practice 2018.

  8. Questionnaires for Measuring Refractive Surgery Outcomes.

    PubMed

    Kandel, Himal; Khadka, Jyoti; Lundström, Mats; Goggin, Michael; Pesudovs, Konrad

    2017-06-01

    To identify the questionnaires used to assess refractive surgery outcomes, assess the available questionnaires in regard to their psychometric properties, validity, and reliability, and evaluate the performance of the available questionnaires in measuring refractive surgery outcomes. An extensive literature search was done on PubMed, MEDLINE, Scopus, CINAHL, Cochrane, and Web of Science databases to identify articles that described or used at least one questionnaire to assess refractive surgery outcomes. The information on content quality, validity, reliability, responsiveness, and psychometric properties was extracted and analyzed based on an extensive set of quality criteria. Eighty-one articles describing 27 questionnaires (12 refractive error-specific, including 4 refractive surgery-specific, 7 vision-but-non-refractive, and 8 generic) were included in the review. Most articles (56, 69.1%) described refractive error-specific questionnaires. The Quality of Life Impact of Refractive Correction (QIRC), the Quality of Vision (QoV), and the Near Activity Visual Questionnaire (NAVQ) were originally constructed using Rasch analysis; others were developed using the Classical Test Theory. The National Eye Institute Refractive Quality of Life questionnaire was the most frequently used questionnaire, but it does not provide a valid measurement. The QoV, QIRC, and NAVQ are the three best existing questionnaires to assess visual symptoms, quality of life, and activity limitations, respectively. This review identified three superior quality questionnaires for measuring different aspects of quality of life in refractive surgery. Clinicians and researchers should choose a questionnaire based on the concept being measured with superior psychometric properties. [J Refract Surg. 2017;33(6):416-424.]. Copyright 2017, SLACK Incorporated.

  9. The development and validation of a multidimensional sum-scaling questionnaire to measure patient-reported outcomes in acute respiratory tract infections in primary care: the acute respiratory tract infection questionnaire.

    PubMed

    Aabenhus, Rune; Thorsen, Hanne; Siersma, Volkert; Brodersen, John

    2013-01-01

    Patient-reported outcomes are seldom validated measures in clinical trials of acute respiratory tract infections (ARTIs) in primary care. We developed and validated a patient-reported outcome sum-scaling measure to assess the severity and functional impacts of ARTIs. Qualitative interviews and field testing among adults with an ARTI were conducted to ascertain a high degree of face and content validity of the questionnaire. Subsequently, a draft version of the Acute Respiratory Tract Infection Questionnaire (ARTIQ) was statistically validated by using the partial credit Rasch model to test dimensionality, objectivity, and reliability of items. Test of known groups' validity was conducted by comparing participants with and without an ARTI. The final version of the ARTIQ consisted of 38 items covering five dimensions (Physical-upper, Physical-lower, Psychological, Sleep, and Medicine) and five single items. All final dimensions were confirmed to fit the Rasch model, thus enabling sum-scaling of responses. The ARTIQ scores in participants with an ARTI were significantly higher than in those without ARTI (known groups' validity). A self-administered, multidimensional, sum-scaling questionnaire with high face and content validity and adequate psychometric properties for assessing severity and functional impacts from ARTIs in adults is available to clinical trials and audits in primary care. Copyright © 2013, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.

  10. Evaluating Questionnaires Used to Assess Self-Reported Physical Activity and Psychosocial Outcomes Among Survivors of Adolescent and Young Adult Cancer: A Cognitive Interview Study.

    PubMed

    Wurz, Amanda; Brunet, Jennifer

    2017-09-01

    Physical activity is increasingly being studied as a way to improve psychosocial outcomes (e.g., quality of life, self-efficacy, physical self-perceptions, self-esteem, body image, posttraumatic growth) among survivors of adolescent and young adult (AYA) cancer. Assessing levels of and associations between self-reported physical activity and psychosocial outcomes requires clear, appropriate, and relevant questionnaires. To explore how survivors of AYA cancer interpreted and responded to the following eight published questionnaires: Leisure Time Exercise Questionnaire, Exercise Self-Efficacy Scale, Physical Self-Description Questionnaire, Rosenberg Global Self-Esteem Scale, Multidimensional Body-Self Relations Questionnaire, Posttraumatic Growth Inventory, Functional Assessment of Cancer Therapy-General (FACT-G), RAND 36-Item Health Survey 1.0 (RAND-36), cognitive interviews were conducted with three men and four women age 18-36 years who were diagnosed with cancer at age 16-35 years. Initially, the first seven questionnaires listed above were assessed. Summaries of the interviews were prepared and compared across participants. Potential concerns were identified with the FACT-G; thus, a second interview was conducted with participants to explore the clarity, appropriateness, and relevance of the RAND-36. Concerns identified for the FACT-G related mostly to the lack of relevance of items pertaining to cancer-specific aspects of quality of life given that participants were posttreatment. No or few concerns related to comprehension and/or structure/logic were identified for the other questionnaires. In general, the questionnaires assessed were clear, appropriate, and relevant. Participants' feedback suggested they could be used to assess self-reported physical activity and varied psychosocial outcomes in studies with survivors of AYA cancer, either with or without slight modifications.

  11. Development and initial psychometric evaluation of patient-reported outcome questionnaires to evaluate the symptoms and impact of hidradenitis suppurativa.

    PubMed

    Kimball, Alexa B; Sundaram, Murali; Banderas, Benjamin; Foley, Catherine; Shields, Alan L

    2018-03-01

    Two patient-reported outcome (PRO) questionnaires, the Hidradenitis Suppurativa Symptom Assessment (HSSA) and Hidradenitis Suppurativa Impact Assessment (HSIA), were developed to measure signs, symptoms and impacts of HS in treatment efficacy studies. In accordance with FDA guidelines and published best practices, four stages of research were conducted to create the questionnaires: concept elicitation, questionnaire construction, content evaluation and psychometric evaluation. Subjects (N = 20) who participated in the concept elicitation stage reported 15 unique HS-related signs and symptoms and 51 impacts. Following this, eight sign and symptom concepts and 21 impacts were selected for construction of the HSSA and HSIA, respectively. During content evaluation, cognitive debriefing interviews with HS subjects (N = 20) confirmed subjects could read, comprehend and meaningfully respond to both questionnaires. Modifications made after this stage of work resulted in a nine-item HSSA and a 17-item HSIA. The HSSA and HSIA were subsequently entered into a US-based observational study (N = 40), and the scores produced by each were found to be reliable, construct valid, and able to distinguish among clinically distinct groups. The HSSA and HSIA are content-valid, HS-specific, PRO questionnaires with demonstrated ability to generate reliable, valid scores when administered to patients with HS in a research setting.

  12. Evaluating the Responsiveness to Therapeutic Change with Routine Outcome Monitoring: A Comparison of the Symptom Questionnaire-48 (SQ-48) with the Brief Symptom Inventory (BSI) and the Outcome Questionnaire-45 (OQ-45).

    PubMed

    Carlier, Ingrid V E; Kovács, Viktória; van Noorden, Martijn S; van der Feltz-Cornelis, Christina; Mooij, Nanda; Schulte-van Maaren, Yvonne W M; van Hemert, Albert M; Zitman, Frans G; Giltay, Erik J

    2017-01-01

    Assessment of psychological distress is important, because it may help to monitor treatment effects and predict treatment outcomes. We previously developed the 48-item Symptom Questionnaire (SQ-48) as a public domain self-report psychological distress instrument and showed good internal consistency as well as good convergent and divergent validity among clinical and non-clinical samples. The present study, conducted among psychiatric outpatients in a routine clinical setting, describes additional psychometric properties of the SQ-48. The primary focus is on responsiveness to therapeutic change, which to date has been rarely examined within psychiatry or clinical psychology. Since a questionnaire should also be stable when no clinically important change occurs, we also examined test-retest reliability within a test-retest design before treatment (n = 43). A pre-treatment/post-treatment design was used for responsiveness to therapeutic change, comparing the SQ-48 with two internationally widely used instruments: the Brief Symptom Inventory (n = 97) and the Outcome Questionnaire-45 (n = 109). The results showed that the SQ-48 has excellent test-retest reliability and good responsiveness to therapeutic change, without significant differences between the questionnaires in terms of responsiveness. In sum, the SQ-48 is a psychometrically sound public domain self-report instrument that can be used for routine outcome monitoring, as a benchmark tool or for research purposes. Copyright © 2015 John Wiley & Sons, Ltd. Key Practitioner Message The SQ-48 is developed as a public domain self-report questionnaire, in line with growing efforts to develop clinical instruments that are free of charge. The SQ-48 has excellent test-retest reliability and good responsiveness to therapeutic change or patient progress. There were no significant differences in terms of responsiveness between the SQ-48 and BSI or OQ-45. The SQ-48 can be used as a routine evaluation outcome

  13. Using the Evaluative Linguistic Framework for Questionnaires to Assess Comprehensibility of Self-Report Health Questionnaires.

    PubMed

    Clerehan, Rosemary; Guillemin, Francis; Epstein, Jonathan; Buchbinder, Rachelle

    2016-06-01

    The Evaluative Linguistic Framework (ELF) was developed to judge the quality of health care texts for patients, based on systemic functional linguistic theory. This approach considers key variables such as context and structure, known to be important for communication. Our objective was to adapt the ELF to evaluate the quality of self-report questionnaires. We reviewed the Health Literacy Questionnaire using the ELF. On the basis of these data, we drafted the preliminary version of the Evaluative Linguistic Framework for Questionnaires (ELF-Q) and applied it to English- and French-language versions of two arthritis self-report questionnaires and to Spanish, Dutch, and Turkish versions of an arthritis questionnaire. The developed ELF-Q was found to be effective for evaluating questionnaires in English and in four other languages. It contains nine items with new descriptions and assessment probes. These include overall organizational or generic structure of the questionnaire, metadiscourse (or text about the text), headings, rhetorical elements (function of each "move" or stage of the text in relation to the reader), the writer-reader relationship, technicality of vocabulary, lexical density (proportion of content words in the text), format, and overall judgment. We added assessment responses on a two- or three-point Likert scale to complement the assessment probes and make the intent and meaning of the probes fully explicit for the questionnaire developer or assessor. The ELF-Q is a framework practical to use for the development or assessment of any type of self-report questionnaire. Its application can identify features of a self-report questionnaire that could be improved to optimize its comprehensibility. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  14. French translation and cross-cultural adaptation of the Michigan Hand Outcomes Questionnaire and the Brief Michigan Hand Outcomes Questionnaire.

    PubMed

    Efanov, J I; Shine, J J; Darwich, R; Besner Morin, C; Arsenault, J; Harris, P G; Danino, A M; Izadpanah, A

    2018-04-01

    Patient-Reported Outcome Measures (PROMs) are important clinical devices for evaluating injuries and surgeries of the hand. However, some of the most widely used questionnaires, such as the MHQ and bMHQ, are currently unavailable in French, which prevents them from being used in the French Canadian province of Quebec as well as in other French-speaking nations. We therefore intend to develop valid and culturally adapted French translations of the afore-mentioned questionnaires. Two independent bilingual translators converted all English questionnaires to French. Two distinct translators then translated the French versions back to English in reverse-blinded fashion. Discrepancies between the original and second English versions were examined by a committee of four bilingual healthcare professionals before final French translations of all documents were produced. Thirty patients bilingual in French and English were then asked to complete the original and French versions of the MHQ and bMHQ. Their answers were compared in order to assess the accuracy of our translation. In light of these findings, revised French versions were produced. French versions of the MHQ and bMHQ questionnaires produced metrological qualities of validity and fidelity with an inter-class correlation superior to 0.90 and a kappa coefficient of 0.81 to 1. Clinical applicability revealed the distribution of scores according to disease process was reproducible between the English and French versions. PROM translation requires a rigorous process in order to achieve strong metrological qualities in both the original and translated versions. We produced French translations of the MHQ and bMHQ by abiding to the Beaton method of cross-cultural adaptation of self-reported measures. Copyright © 2017 SFCM. Published by Elsevier Masson SAS. All rights reserved.

  15. Development and content validity testing of a patient-reported outcomes questionnaire for the assessment of hereditary angioedema in observational studies.

    PubMed

    Bonner, Nicola; Abetz-Webb, Linda; Renault, Lydie; Caballero, Teresa; Longhurst, Hilary; Maurer, Marcus; Christiansen, Sandra; Zuraw, Bruce

    2015-07-01

    Hereditary Angioedema (HAE), a rare genetic disease, manifests as intermittent, painful attacks of angioedema. Attacks vary in frequency and severity and include skin, abdominal and life-threatening laryngeal swellings. This study aimed to develop a patient reported outcome (PRO) tool for the assessment of HAE attacks, including their management and impact on patients' lives, for use in clinical studies, or by physicians in general practice. The results of open-ended face to face concept elicitation interviews with HAE patients in Argentina (n = 10) and the US (n = 33) were used to develop the first draft questionnaire of the HAE patient reported outcomes questionnaire (HAE PRO). Subsequently, in-depth cognitive debriefing interviews were performed with HAE patients in the UK (n = 10), Brazil (n = 10), Germany (n = 11) and France (n = 12). Following input from eight multinational clinical experts further cognitive interviews were conducted in the US (n = 12) and Germany (n = 12). Patients who experienced abdominal, cutaneous or laryngeal attacks of varying severity levels were included in all rounds of interviews. Across the rounds of interviews patients discussed their HAE attack symptoms, impacts and treatments. Cognitive debriefing interviews explored patient understanding and relevance of questionnaire items. All interviews were conducted face to face following a pre-defined semi-structured interview guide in the patient's native language. Patients reported a variety of HAE symptoms, attack triggers, warning signs, attack impacts and treatment options which were used to develop the HAE PRO. The HAE PRO was revised and refined following input from patients and clinical experts. The final 18-item HAE PRO provides an assessment of the HAE attack experience including symptoms, impacts, treatment requirements, healthcare resource use and loss of productivity caused by HAE attacks. Patient and expert input has contributed to the

  16. Patients' perception of postoperative pain management: validation of the International Pain Outcomes (IPO) questionnaire.

    PubMed

    Rothaug, Judith; Zaslansky, Ruth; Schwenkglenks, Matthias; Komann, Marcus; Allvin, Renée; Backström, Ragnar; Brill, Silviu; Buchholz, Ingo; Engel, Christoph; Fletcher, Dominique; Fodor, Lucian; Funk, Peter; Gerbershagen, Hans J; Gordon, Debra B; Konrad, Christoph; Kopf, Andreas; Leykin, Yigal; Pogatzki-Zahn, Esther; Puig, Margarita; Rawal, Narinder; Taylor, Rod S; Ullrich, Kristin; Volk, Thomas; Yahiaoui-Doktor, Maryam; Meissner, Winfried

    2013-11-01

    PAIN OUT is a European Commission-funded project aiming at improving postoperative pain management. It combines a registry that can be useful for quality improvement and research using treatment and patient-reported outcome measures. The core of the project is a patient questionnaire-the International Pain Outcomes questionnaire-that comprises key patient-level outcomes of postoperative pain management, including pain intensity, physical and emotional functional interference, side effects, and perceptions of care. Its psychometric quality after translation and adaptation to European patients is the subject of this validation study. The questionnaire was administered to 9,727 patients in 10 languages in 8 European countries and Israel. Construct validity was assessed using factor analysis. Discriminant validity assessment used Mann-Whitney U tests to detect mean group differences between 2 surgical disciplines. Internal consistency reliability was calculated as Cronbach's alpha. Factor analysis resulted in a 3-factor structure explaining 53.6% of variance. Cronbach's alpha at overall scale level was high (.86), and for the 3 subscales was low, moderate, or high (range, .53-.89). Significant mean group differences between general and orthopedic surgery patients confirmed discriminant validity. The psychometric quality of the International Pain Outcomes questionnaire can be regarded as satisfactory. The International Pain Outcomes questionnaire provides an instrument for postoperative pain assessment and improvement of quality of care, which demonstrated good psychometric quality when translated into a variety of languages in a large European and Israeli patient population. This measure provides the basis for the first comprehensive postoperative pain registry in Europe and other countries. Copyright © 2013. Published by Elsevier Inc.

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

    PubMed Central

    Sutton, Anna

    2016-01-01

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

  18. Measurement versus prediction in the construction of patient-reported outcome questionnaires: can we have our cake and eat it?

    PubMed

    Smits, Niels; van der Ark, L Andries; Conijn, Judith M

    2017-11-02

    the remaining items. (3) Yes, these methods may lead to different item selections. (4) For a single questionnaire: Yes, but it is problematic because reliability cannot be estimated accurately. For a test battery: Yes, but it is very costly. Implications for the construction of patient-reported outcome questionnaires are discussed.

  19. 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.

  20. 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

  1. Assessment of postoperative outcomes of hypospadias repair with validated questionnaires.

    PubMed

    Liu, Mona M Y; Holland, Andrew J A; Cass, Danny T

    2015-12-01

    A standardized assessment for the optimal repair of hypospadias remains elusive. This study utilized validated questionnaires to assess the postoperative functional, cosmetic, and psychosocial outcomes of hypospadias repair. 172 patients who underwent hypospadias repair under the care of a single surgeon were identified. 25 agreed for follow-up using the validated questionnaires of Hypospadias Objective Scoring Evaluation (HOSE), Pediatric Penile Perception Scale (PPPS), and Pediatric Quality of Life Inventory (PedsQL™4.0). Mean follow-up was 59months postoperatively (range 7-113months). Techniques used included tubularized incised plate urethroplasty, meatal advancement and glanuloplasty, and a 2-stage repair. 23 of 25 patients achieved a HOSE score of 14 or more (maximum of 16). The PPPS scores correlated with severity of the hypospadias. Those with glanular hypospadias (mean score=10) scored higher than those with coronal (mean score=9) and penile/penoscrotal hypospadias (mean score=7). There was no correlation between PedsQL™4.0 scores and the severity of hypospadias or procedure used. Validated questionnaires revealed generally good functional, cosmetic, and early psychosocial outcomes after hypospadias repair. The use of validated questionnaires in routine follow-up sessions may facilitate objective assessment of both functional outcomes and patient satisfaction. Copyright © 2015 Elsevier Inc. All rights reserved.

  2. 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

  3. Catquest questionnaire for use in cataract surgery care: assessment of surgical outcomes.

    PubMed

    Lundström, M; Stenevi, U; Thorburn, W; Roos, P

    1998-07-01

    To demonstrate the outcome for patients after cataract extraction using the Catquest cataract questionnaire and discuss the models validity in assessing outcome. Thirty-five Swedish departments of ophthalmology. Patients having cataract extraction performed by surgeons from 35 Swedish departments of opthalmology participated in the study. The questionnaire was given to 2970 consecutive patients having surgery during March 1995 at the participating surgical units. The questionnaire was sent by mail to patients and completed on a voluntary basis. It focuses on visual disabilities in daily life, activity level, cataract symptoms, and degree of independence. The results form the questionnaire are interpreted using a benefit matrix that credits not only a decrease in visual disabilities and cataract symptoms but also an improvement in or maintenance of a preoperative activity level. Complete surgical outcome data and completed preoperative and postoperative questionnaires were available in 1933 cases (65.1%). Benefit from surgery according to the model was achieved by 90.9% of the patients. Patients having their second cataract extraction had the highest frequency of the greatest benefit form surgery. There was good agreement between the different levels of benefit from surgery according to the model and the patient's global rating of his or her vision or achieved visual acuity after surgery, respectively. Patients with missing data (did not return postoperative questionnaire or had missing surgical result variables) were older and had a higher frequency of other diseases and handicaps. The Catquest cataract questionnaire allowed the outcome of cataract surgery to be graded by different levels of benefit. There seemed to be good agreement between this model of assessment and the patient's global rating of his or her vision. Missing data may be a problem when a postal questionnaire is used.

  4. 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…

  5. Web-based questionnaires to assess perinatal outcome proved to be valid.

    PubMed

    van Gelder, Marleen M H J; Vorstenbosch, Saskia; Derks, Lineke; Te Winkel, Bernke; van Puijenbroek, Eugène P; Roeleveld, Nel

    2017-10-01

    The objective of this study was to validate a Web-based questionnaire completed by the mother to assess perinatal outcome used in a prospective cohort study. For 882 women with an estimated date of delivery between February 2012 and February 2015 who participated in the PRegnancy and Infant DEvelopment (PRIDE) Study, we compared data on pregnancy outcome, including mode of delivery, plurality, gestational age, birth weight and length, head circumference, birth defects, and infant sex, from Web-based questionnaires administered to the mothers 2 months after delivery with data from obstetric records. For continuous variables, we calculated intraclass correlation coefficients (ICCs) with 95% confidence intervals (CIs), whereas sensitivity and specificity were determined for categorical variables. We observed only very small differences between the two methods of data collection for gestational age (ICC, 0.91; 95% CI, 0.90-0.92), birth weight (ICC, 0.96; 95% CI, 0.95-0.96), birth length (ICC, 0.90; 95% CI, 0.87-0.92), and head circumference (ICC, 0.88; 95% CI, 0.80-0.93). Agreement between the Web-based questionnaire and obstetric records was high as well, with sensitivity ranging between 0.86 (termination of pregnancy) and 1.00 (four outcomes) and specificity between 0.96 (term birth) and 1.00 (nine outcomes). Our study provides evidence that Web-based questionnaires could be considered as a valid complementary or alternative method of data collection. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. 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…

  7. 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. Copyright © 2011 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

  8. An Examination of the "Interpersonalness" of the Outcome Questionnaire

    ERIC Educational Resources Information Center

    Hess, Timothy R.; Rohlfing, Jessica E.; Hardy, Amanda O.; Glidden-Tracey, Cynthia; Tracey, Terence J. G.

    2010-01-01

    This study examined whether the Outcome Questionnaire-45 (OQ) and its subscales assessed unique interpersonal distress. The Inventory of Interpersonal Problems (IIP) was used to assess discriminant validity for unique interpersonal distress. Participants (N = 121) were recruited from a southwestern university counselor training center. Significant…

  9. Assessment of the Psychometric Properties of a Questionnaire Assessing Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL).

    PubMed

    Hays, Ron D; Tarver, Michelle E; Spritzer, Karen L; Reise, Steve; Hilmantel, Gene; Hofmeister, Elizabeth M; Hammel, Keri; May, Jeanine; Ferris, Frederick; Eydelman, Malvina

    2017-01-01

    Patient-reported outcome (PRO) measures for laser in situ keratomileusis (LASIK) are needed. To develop PRO measures to assess satisfaction, eye-related symptoms, and their effect on functioning and well-being following LASIK based on patient and expert input. The Patient-Reported Outcomes With LASIK (PROWL) studies were prospective observational studies of patients undergoing LASIK surgery for myopia, hyperopia, or astigmatism. PROWL-1 was a single-center study of active-duty US Navy personnel and PROWL-2 was a 5-center study of civilians. PROWL-1 enrolled 262 active-duty service personnel and PROWL-2 enrolled 312 civilians 21 years or older who spoke English; 241 individuals in PROWL-1 and 280 in PROWL-2 completed a baseline questionnaire before surgery. The analytic sample included those also completing 1 or more follow-up questionnaires: 240 (99.6%) of those in PROWL-1 and 271 (94.4%) of those in PROWL-2. Questionnaires were self-administered through the internet preoperatively and at 1 and 3 months postoperatively in both studies and at 6 months postoperatively in PROWL-1. PROWL-1 began in August 2011 and was completed May 30, 2014; PROWL-2 began in July 2012 and was completed June 27, 2014. Data were analyzed from June 28, 2014, to October 24, 2016. Scales assessing visual symptoms (double images, glare, halos, and starbursts), dry eye symptoms, satisfaction with vision, and satisfaction with LASIK surgery. Items from the National Eye Institute (NEI) Refractive Error Quality of Life Instrument (NEI-RQL-42), NEI Visual Function Questionnaire (NEI-VFQ), and the Ocular Surface Disease Index (OSDI) were included. All scales are scored on a 0 to 100 possible range. Construct validity and responsiveness to change were evaluated (comparing scores before and after surgery). The median age of the 240-person PROWL-1 analytic sample was 27 years (range, 21-52 years); 49 were women (20.4%). The median age of the 271-person PROWL-2 analytic sample was 30 years (range, 21

  10. Patient-reported allergies cause inferior outcomes after total knee arthroplasty.

    PubMed

    Hinarejos, Pedro; Ferrer, Tulia; Leal, Joan; Torres-Claramunt, Raul; Sánchez-Soler, Juan; Monllau, Joan Carles

    2016-10-01

    The main objective of this study was to analyse the outcomes after total knee arthroplasty (TKA) of a group of patients with at least one self-reported allergy and a group of patients without reported allergies. We hypothesized there is a significant negative influence on clinical outcome scores after TKA in patients with self-reported allergies. Four-hundred and seventy-five patients who had undergone TKA were analysed preoperatively and 1 year after surgery. The WOMAC, KSS and SF-36 scores were obtained. The patients' Yesavage depression questionnaire score was also recorded. The scores of the 330 (69.5 %) patients without self-reported allergies were compared to the scores of the 145 (30.5 %) patients with at least one self-reported allergy in the medical record. Preoperative scores were similar in both groups. The WOMAC post-operative scores (23.6 vs 20.4; p = 0.037) and the KSS-Knee score (91.1 vs 87.6; p = 0.027) were worse in the group of patients with self-reported allergies than in the group without allergies. The scores from the Yesavage depression questionnaire and in the SF-36 were similar in both groups. Patients with at least one self-reported allergy have worse post-operative outcomes in terms of the WOMAC and KSS-Knee scores after TKA than patients without allergies. These poor outcomes do not seem to be related to depression. Therefore, more research is needed to explain them. Reported allergies could be considered a prognostic factor and used when counselling TKA patients. I.

  11. How to Improve the Validity of Sexual Behaviour Reporting: Systematic Review of Questionnaire Delivery Modes in Developing Countries

    PubMed Central

    Langhaug, Lisa F.; Sherr, Lorraine; Cowan, Frances M

    2012-01-01

    Summary Objectives To systematically review comparative research from developing countries on the effects of questionnaire delivery mode. Methods We searched Medline, EMbase and PsychINFO and ISSTDR conference proceedings. Randomized-controlled trials and quasi-experimental studies were included if they compared two or more questionnaire delivery modes, were conducted in a developing country, reported on sexual behaviours, and occurred after 1980. Results 28 articles reporting on 26 studies met the inclusion criteria. Heterogeneity of reported trial outcomes between studies made it inappropriate to combine trial outcomes. 18 studies compared audio computer-assisted survey instruments (ACASI) or its derivatives (PDA or CAPI) against another self-administered questionnaires, face-to-face interviews, or random response technique. Despite wide variation in geography and populations sampled, there was strong evidence that computer-assisted interviews lowered item-response rates and raised rates of reporting sensitive behaviours. ACASI also improved data entry quality. A wide range of sexual behaviours were reported including vaginal, oral, anal and/or forced sex, age of sexual debut, condom use at first and/or last sex. Validation of self-reports using biomarkers was rare. Conclusions These data reaffirm that questionnaire delivery modes do affect self-reported sexual ehaviours and that use of ACASI can significantly reduce reporting bias. Its acceptability and feasibility in developing country settings should encourage researchers to consider its use when conduct ing sexual health research. Triangulation of self-reported data using biomarkers is recommended. Standardising sexual behaviour measures would allow for meta-analysis. PMID:20409291

  12. A comparison of the readability of two patient-reported outcome measures used to evaluate foot surgery.

    PubMed

    Alvey, James; Palmer, Simon; Otter, Simon

    2012-01-01

    Measuring the outcome of surgical intervention is an integral part of modern-day healthcare provision. The increasing requirement to monitor patient-reported outcomes highlights the need for patients to be able to read and understand health outcomes questionnaires. The present study compared the readability of 2 commonly used, validated, foot surgery outcome questionnaires (the Foot Health Status Questionnaire and the Manchester-Oxford Foot Questionnaire) using the Flesch Reading Ease score and the Flesch-Kincaid grade level score. The Manchester-Oxford Foot Questionnaire had a significantly greater (p < .003) score for reading ease and a significantly lower reading grade score (p < .005) than the Foot Health Status Questionnaire. These findings suggest the Manchester-Oxford Foot Questionnaire is a more suitable instrument in terms of readability and comprehension for a greater proportion of the population undergoing hallux valgus surgery. Copyright © 2012 American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.

  13. Single-joint outcome measures: preliminary validation of patient-reported outcomes and physical examination.

    PubMed

    Heald, Alison E; Fudman, Edward J; Anklesaria, Pervin; Mease, Philip J

    2010-05-01

    To assess the validity, responsiveness, and reliability of single-joint outcome measures for determining target joint (TJ) response in patients with inflammatory arthritis. Patient-reported outcomes (PRO), consisting of responses to single questions about TJ global status on a 100-mm visual analog scale (VAS; TJ global score), function on a 100-mm VAS (TJ function score), and pain on a 5-point Likert scale (TJ pain score) were piloted in 66 inflammatory arthritis subjects in a phase 1/2 clinical study of an intraarticular gene transfer agent and compared to physical examination measures (TJ swelling, TJ tenderness) and validated function questionnaires (Disabilities of the Arm, Shoulder and Hand scale, Rheumatoid Arthritis Outcome Score, and the Health Assessment Questionnaire). Construct validity was assessed by evaluating the correlation between the single-joint outcome measures and validated function questionnaires using Spearman's rank correlation. Responsiveness or sensitivity to change was assessed through calculating effect size and standardized response means (SRM). Reliability of physical examination measures was assessed by determining interobserver agreement. The single-joint PRO were highly correlated with each other and correlated well with validated functional measures. The TJ global score exhibited modest effect size and modest SRM that correlated well with the patient's assessment of response on a 100-mm VAS. Physical examination measures exhibited high interrater reliability, but correlated less well with validated functional measures and the patient's assessment of response. Single-joint PRO, particularly the TJ global score, are simple to administer and demonstrate construct validity and responsiveness in patients with inflammatory arthritis. (ClinicalTrials.gov identifier NCT00126724).

  14. Translation, adaptation and validation of the Coronary Revascularization Outcome Questionnaire into Greek.

    PubMed

    Takousi, Maria G; Schmeer, Stefanie; Manaras, Irene; Olympios, Christoforos D; Fakiolas, Constantine N; Makos, Georgios; Troop, Nick A

    2016-04-01

    Evaluating the impact of coronary revascularization on patients' health related quality of life with a patient-based and disease-specific tool is important for drawing conclusions about treatment and outcomes. This study reports on the translation, adaptation and psychometric evaluation of a Greek version of the Coronary Revascularization Outcome Questionnaire (CROQ-Gr). A total of 609 (81.7% male) patients who had undergone coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) were recruited from four hospitals in Athens. After translating the CROQ into Greek, a preliminary qualitative study and a pilot quantitative study were conducted. A full psychometric evaluation was carried out on the main study's data. The psychometric evaluation demonstrated that the CROQ-Gr is acceptable to patients (high response rate, low missing data) and has a good level of reliability (internal consistency >0.70, test-retest reliability >0.90) and validity (both content and construct validity). The results of this study show the CROQ-Gr to be a psychometrically rigorous patient-based measure of outcomes of coronary revascularization. It would be appropriate for use in evaluative research as well as a routine clinical tool to aid cardiologists in monitoring the outcomes of care. © The European Society of Cardiology 2015.

  15. 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…

  16. Worse patient-reported outcome after lateral approach than after anterior and posterolateral approach in primary hip arthroplasty. A cross-sectional questionnaire study of 1,476 patients 1-3 years after surgery.

    PubMed

    Amlie, Einar; Havelin, Leif I; Furnes, Ove; Baste, Valborg; Nordsletten, Lars; Hovik, Oystein; Dimmen, Sigbjorn

    2014-09-01

    The surgical approach in total hip arthroplasty (THA) is often based on surgeon preference and local traditions. The anterior muscle-sparing approach has recently gained popularity in Europe. We tested the hypothesis that patient satisfaction, pain, function, and health-related quality of life (HRQoL) after THA is not related to the surgical approach. 1,476 patients identified through the Norwegian Arthroplasty Register were sent questionnaires 1-3 years after undergoing THA in the period from January 2008 to June 2010. Patient-reported outcome measures (PROMs) included the hip disability osteoarthritis outcome score (HOOS), the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), health-related quality of life (EQ-5D-3L), visual analog scales (VAS) addressing pain and satisfaction, and questions about complications. 1,273 patients completed the questionnaires and were included in the analysis. Adjusted HOOS scores for pain, other symptoms, activities of daily living (ADL), sport/recreation, and quality of life were significantly worse (p < 0.001 to p = 0.03) for the lateral approach than for the anterior approach and the posterolateral approach (mean differences: 3.2-5.0). These results were related to more patient-reported limping with the lateral approach than with the anterior and posterolateral approaches (25% vs. 12% and 13%, respectively; p < 0.001). Patients operated with the lateral approach reported worse outcomes 1-3 years after THA surgery. Self-reported limping occurred twice as often in patients who underwent THA with a lateral approach than in those who underwent THA with an anterior or posterolateral approach. There were no significant differences in patient-reported outcomes after THA between those who underwent THA with a posterolateral approach and those who underwent THA with an anterior approach.

  17. Development of a new occupational balance-questionnaire: incorporating the perspectives of patients and healthy people in the design of a self-reported occupational balance outcome instrument

    PubMed Central

    2014-01-01

    Background Self-reported outcome instruments in health research have become increasingly important over the last decades. Occupational therapy interventions often focus on occupational balance. However, instruments to measure occupational balance are scarce. The aim of the study was therefore to develop a generic self-reported outcome instrument to assess occupational balance based on the experiences of patients and healthy people including an examination of its psychometric properties. Methods We conducted a qualitative analysis of the life stories of 90 people with and without chronic autoimmune diseases to identify components of occupational balance. Based on these components, the Occupational Balance-Questionnaire (OB-Quest) was developed. Construct validity and internal consistency of the OB-Quest were examined in quantitative data. We used Rasch analyses to determine overall fit of the items to the Rasch model, person separation index and potential differential item functioning. Dimensionality testing was conducted by the use of t-tests and Cronbach’s alpha. Results The following components emerged from the qualitative analyses: challenging and relaxing activities, activities with acknowledgement by the individual and by the sociocultural context, impact of health condition on activities, involvement in stressful activities and fewer stressing activities, rest and sleep, variety of activities, adaptation of activities according to changed living conditions and activities intended to care for oneself and for others. Based on these, the seven items of the questionnaire (OB-Quest) were developed. 251 people (132 with rheumatoid arthritis, 43 with systematic lupus erythematous and 76 healthy) filled in the OB-Quest. Dimensionality testing indicated multidimensionality of the questionnaire (t = 0.58, and 1.66 after item reduction, non-significant). The item on the component rest and sleep showed differential item functioning (health condition and age

  18. Development of a new occupational balance-questionnaire: incorporating the perspectives of patients and healthy people in the design of a self-reported occupational balance outcome instrument.

    PubMed

    Dür, Mona; Steiner, Günter; Fialka-Moser, Veronika; Kautzky-Willer, Alexandra; Dejaco, Clemens; Prodinger, Birgit; Stoffer, Michaela Alexandra; Binder, Alexa; Smolen, Josef; Stamm, Tanja Alexandra

    2014-04-05

    Self-reported outcome instruments in health research have become increasingly important over the last decades. Occupational therapy interventions often focus on occupational balance. However, instruments to measure occupational balance are scarce. The aim of the study was therefore to develop a generic self-reported outcome instrument to assess occupational balance based on the experiences of patients and healthy people including an examination of its psychometric properties. We conducted a qualitative analysis of the life stories of 90 people with and without chronic autoimmune diseases to identify components of occupational balance. Based on these components, the Occupational Balance-Questionnaire (OB-Quest) was developed. Construct validity and internal consistency of the OB-Quest were examined in quantitative data. We used Rasch analyses to determine overall fit of the items to the Rasch model, person separation index and potential differential item functioning. Dimensionality testing was conducted by the use of t-tests and Cronbach's alpha. The following components emerged from the qualitative analyses: challenging and relaxing activities, activities with acknowledgement by the individual and by the sociocultural context, impact of health condition on activities, involvement in stressful activities and fewer stressing activities, rest and sleep, variety of activities, adaptation of activities according to changed living conditions and activities intended to care for oneself and for others. Based on these, the seven items of the questionnaire (OB-Quest) were developed. 251 people (132 with rheumatoid arthritis, 43 with systematic lupus erythematous and 76 healthy) filled in the OB-Quest. Dimensionality testing indicated multidimensionality of the questionnaire (t = 0.58, and 1.66 after item reduction, non-significant). The item on the component rest and sleep showed differential item functioning (health condition and age). Person separation index was 0

  19. 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

  20. Development and validation of the impact of dry eye on everyday life (IDEEL) questionnaire, a patient-reported outcomes (PRO) measure for the assessment of the burden of dry eye on patients.

    PubMed

    Abetz, Linda; Rajagopalan, Krithika; Mertzanis, Polyxane; Begley, Carolyn; Barnes, Rod; Chalmers, Robin

    2011-12-08

    To develop and validate a comprehensive patient-reported outcomes instrument focusing on the impact of dry eye on everyday life (IDEEL). Development and validation of the IDEEL occurred in four phases: 1) focus groups with 45 dry eye patients to develop a draft instrument, 2) item generation, 3) pilot study to assess content validity in 16 patients and 4) psychometric validation in 210 subjects: 130 with non-Sjögren's keratoconjunctivitis sicca, 32 with Sjögren's syndrome and 48 controls, and subsequent item reduction. Focus groups identified symptoms and the associated bother, the impact of dry eye on daily life and the patients' satisfaction with their treatment as the central concepts in patients' experience of dry eye. Qualitative analysis indicated that saturation was achieved for these concepts and yielded an initial 112-item draft instrument. Patients understood the questionnaire and found the items to be relevant indicating content validity. Patient input, item descriptive statistics and factor analysis identified 55 items that could be deleted. The final 57-item IDEEL assesses dry eye impact constituting 3 modules: dry eye symptom-bother, dry eye impact on daily life comprising impact on daily activities, emotional impact, impact on work, and dry eye treatment satisfaction comprising satisfaction with treatment effectiveness and treatment-related bother/inconvenience. The psychometric analysis results indicated that the IDEEL met the criteria for item discriminant validity, internal consistency reliability, test-retest reliability and floor/ceiling effects. As expected, the correlations between IDEEL and the Dry Eye Questionnaire (a habitual symptom questionnaire) were higher than between IDEEL and Short-Form-36 and EuroQoL-5D, indicating concurrent validity. The IDEEL is a reliable, valid and comprehensive questionnaire relevant to issues that are specific to dry eye patients, and meets current FDA patient-reported outcomes guidelines. The use of this

  1. Evaluating patient-reported outcome measurement comparability between paper and alternate versions, using the lung function questionnaire as an example.

    PubMed

    Dalal, Anand A; Nelson, Lauren; Gilligan, Theresa; McLeod, Lori; Lewis, Sandy; DeMuro-Mercon, Carla

    2011-01-01

    The goal of this study was to provide recommended steps to assess measurement comparability using a crossover study design and to demonstrate these steps using a short patient-reported outcome (PRO) instrument as an example. The example PRO instrument was administered via paper, Web, interactive voice response system, and interview; a randomized crossover design was used to gather data across the multiple administration types. Participants completed the PRO instrument, demographic and health questions, and a short preference questionnaire. Evaluation included comparisons of the item-level responses and agreement, comparison of mean scale scores, score classifications, and questions designed to collect usability and administration preference. Here the authors provide a four-step evaluation guide to evaluate measurement comparability and illustrate these steps using a case-finding tool. In the example, item-level kappa statistics between the paper and the alternate versions ranged from good to excellent, intraclass correlation coefficient for mean scores were above 0.70, and the rate of disagreement ranged from 2% to 14%. In addition, although participants had an administration preference, they reported few difficulties with the versions they were assigned. The steps described in this article provide a guide for evaluating whether to combine scores across administration versions to simplify analyses and interpretation under a crossover design. The guide recommends the investigation of item-level responses, summary scores, and participant usability/preference when comparing versions, with each step providing unique information to support comprehensive evaluation and informed decisions regarding whether to combine data. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  2. Patient-reported Outcomes of Tarsal Coalitions Treated With Surgical Excision.

    PubMed

    Mahan, Susan T; Spencer, Samantha A; Vezeridis, Peter S; Kasser, James R

    2015-09-01

    There are little patient-reported data on functional outcomes of tarsal coalition resection in children and adolescents. The purpose of this study is to evaluate the medium-term (>2 y) outcomes in patients who have had surgical excision of their symptomatic tarsal coalition and to compare patient-based outcomes in patients who have calcaneonavicular (CN) coalitions to those with talocalcaneal (TC) coalitions. A billing query was conducted to identify patients who had surgical excision of their tarsal coalition between 2003 and 2008. Eligible patients were mailed questionnaires consisting of a modified American Orthopaedic Foot and Ankle Society (AOFAS) score and the University of California at Los Angeles (UCLA) activity scale. Patients were also specifically asked if their activity level was limited by their foot pain. Only patients who returned questionnaires were included. Demographics and diagnostic images were reviewed. A nonresponder analysis was completed. Complications such as infection and reoperation were reported. Sixty-three patients (22 females, 41 males) who returned questionnaires were included in the analysis. Twenty-four patients had bilateral surgery. TC coalitions were present in 20 patients (32%); CN coalitions were present in 43 patients (68%).Overall, mean modified AOFAS score was 88.3 and mean UCLA activity score was 8.33 at an average of 4.62 years after surgery. Patients who had TC coalitions had similar modified AOFAS scores (88.4) and UCLA activity scores (8.4) when compared with those with CN coalitions (88.0 and 8.3, both not significant).Of the 73% (46/63) patients who reported that their activity levels were not limited by their foot pain, the mean AOFAS score was 93.9 and the mean UCLA activity score was 8.9; 32 of these were CN and 14 were TC coalitions. Of the 27% (17/63) patients who reported that their activity levels were limited by their foot pain, the mean AOFAS score was 72.9 and the mean UCLA activity score was 6.9; 11 of

  3. A preliminary quality of life questionnaire-bronchiectasis: a patient-reported outcome measure for bronchiectasis.

    PubMed

    Quittner, Alexandra L; Marciel, Kristen K; Salathe, Matthias A; O'Donnell, Anne E; Gotfried, Mark H; Ilowite, Jonathan S; Metersky, Mark L; Flume, Patrick A; Lewis, Sandra A; McKevitt, Matthew; Montgomery, A Bruce; O'Riordan, Thomas G; Barker, Alan F

    2014-08-01

    The Quality of Life Questionnaire-Bronchiectasis (QOL-B) is the first disease-specific, patient-reported outcome measure for patients with bronchiectasis. Content validity, cognitive testing, responsivity to open-label treatment, and psychometric analyses are presented. Reviews of literature, existing measures, and physician input were used to generate the initial QOL-B. Modifications following preliminary cognitive testing (N = 35 patients with bronchiectasis) generated version (V) 1.0. An open-ended patient interview study (N = 28) provided additional information and was content analyzed to derive saturation matrices, which summarized all disease-related topics mentioned by each participant. This resulted in QOL-B V2.0. Psychometric analyses were carried out using results from an open-label phase 2 trial, in which 89 patients were enrolled and treated with aztreonam for inhalation solution. Responsivity to open-label treatment was observed. Additional analyses generated QOL-B V3.0, with 37 items on eight scales: respiratory symptoms; physical, role, emotional, and social functioning; vitality; health perceptions; and treatment burden. For each scale, scores are standardized on a 0-to-100-point scale; higher scores indicate better health-related quality of life. No total score is calculated. A final cognitive testing study (N = 40) resulted in a minor change to one social functioning scale item (QOL-B V3.1). Content validity, cognitive testing, responsivity to open-label treatment, and initial psychometric analyses supported QOL-B items and structure. This interim QOL-B is a promising tool for evaluating the efficacy of new therapies for patients with bronchiectasis and for measuring symptoms, functioning, and quality of life in these patients on a routine basis. A final psychometric validation study is needed and is forthcoming. ClinicalTrials.gov; No.: NCT00805025; URL: www.clinicaltrials.gov.

  4. Technical report: an ePRO patient reported outcome program for the evaluation of patients with irritable bowel syndrome.

    PubMed

    Gerson, C D; Gerson, M-J

    2014-02-01

    Patient reported outcome (PRO) is an important healthcare concept that describes patient's participation in their care by self-evaluation, usually in the form of questionnaires. This report describes an unique computerized technique, electronic PRO (ePRO), for following the progress of patients with irritable bowel syndrome (IBS). Patients first completed a series of questionnaires, including questions about their illness history, symptom severity, and, in this application, psychological and relationship issues. The symptom severity and psychological questionnaires were then completed at intervals by the patients on their own computers. The ePRO was constructed to allow scores to be automatically summed and placed on a time-line graph for review at the time of the next office visit. Of the 32 patients who completed the initial set of questionnaires, 20 maintained participation in the program for a 6-month period. Of those 20 patients, median number of submissions was 7.0; median interval between questionnaire submissions was 3.0 weeks, whereas median interval between office visits was 5.9 weeks. On average, questionnaire completion took less than 5 min and was positively experienced by the patients. The ePRO program proved to be technically feasible, clinically useful, and positively experienced by the patients. It provides a focus on a collaborative conversation between physician and patient. It has significant potential as a technique for evaluating outcome in response to various therapies. © 2013 John Wiley & Sons Ltd.

  5. Patient-Reported Outcomes and Return to Activity After Peroneus Brevis Repair.

    PubMed

    Steginsky, Brian; Riley, Aimee; Lucas, Douglas E; Philbin, Terrence M; Berlet, Gregory C

    2016-02-01

    There is limited data on functional outcomes after primary repair of partial peroneal tendon tears. Previous reports have been limited by small cohorts, duration of follow-up, and often included both tenodesis and primary repair. The purpose of this study was to report the functional outcomes and return to activity in the largest cohort to date with partial peroneal tendon tears treated with primary repair. A chart review identified all patients who underwent primary repair of the peroneus brevis tendon from 2008 to 2012. Demographic data, magnetic resonance imaging findings, and postoperative complications were reviewed. Patients were asked to complete a follow-up questionnaire, Foot and Ankle Ability Measure (FAAM), and Foot Function Index (FFI). There were 201 patients who underwent primary repair of the peroneus brevis tendon. The average age at time of operation was 44.3 years. Seventy-one patients returned the follow-up questionnaires with an average follow-up of 4.6 years. Fifty-two patients completed the FFI questionnaire preoperatively and postoperatively. Fifty-nine patients (83.1%) reported a return to regular exercise and sports at final follow-up. At 1 year postoperatively, 76.5% of patients returned to the same preinjury activities, and 62.3% returned to the same level of preinjury activity. Furthermore, 85.9% of patients were satisfied with their outcome, and 91.4% of patients reported they would choose to undergo the same procedure again. The mean FAAM score was 85.2 at follow-up. The mean preoperative and postoperative FFI score was 41.1 and 12.2, respectively. There was a significant improvement in the FFI score of 28.9 after primary peroneus brevis tendon repair (P < .001). Primary repair of peroneus brevis tendon provided consistent improvement in functional outcomes in the majority of patients, as measured by a validated scoring system, the FFI. FAAM scores demonstrated good function compared to historical controls. The majority of patients

  6. Menstrual questionnaires for clinical and research use.

    PubMed

    Matteson, Kristen A

    2017-04-01

    Patient-reported outcome measures (PROMs) have the potential to be extremely valuable in the clinical care delivery for women who report heavy menstrual bleeding (HMB). Increasingly, studies on HMB have incorporated PROMs to evaluate the impact of bleeding on quality of life. These measures have included semiquantitative charts and pictograms, questionnaires to assess symptoms and impact on quality of life, and health-related quality of life questionnaires. Recent systematic reviews have highlighted inconsistency of outcome measurement across studies on HMB as a challenge limiting the interpretability of the body of literature and the ability to generate consensus on the relative effectiveness of treatment options. Consequently, research initiatives and international collaborations are working to harmonize outcome measurement. Harmonizing the use of questionnaires in research and clinical care has the potential to improve patient-centered care delivery for women with HMB and improve the generation of patient-focused evidence-based guidelines for the evaluation and treatment of HMB. Copyright © 2016. Published by Elsevier Ltd.

  7. Patient-reported physical activity questionnaires: A systematic review of content and format

    PubMed Central

    2012-01-01

    Background Many patients with chronic illness are limited in their physical activities. This systematic review evaluates the content and format of patient-reported outcome (PRO) questionnaires that measure physical activity in elderly and chronically ill populations. Methods Questionnaires were identified by a systematic literature search of electronic databases (Medline, Embase, PsychINFO & CINAHL), hand searches (reference sections and PROQOLID database) and expert input. A qualitative analysis was conducted to assess the content and format of the questionnaires and a Venn diagram was produced to illustrate this. Each stage of the review process was conducted by at least two independent reviewers. Results 104 questionnaires fulfilled our criteria. From these, 182 physical activity domains and 1965 items were extracted. Initial qualitative analysis of the domains found 11 categories. Further synthesis of the domains found 4 broad categories: 'physical activity related to general activities and mobility', 'physical activity related to activities of daily living', 'physical activity related to work, social or leisure time activities', and '(disease-specific) symptoms related to physical activity'. The Venn diagram showed that no questionnaires covered all 4 categories and that the '(disease-specific) symptoms related to physical activity' category was often not combined with the other categories. Conclusions A large number of questionnaires with a broad range of physical activity content were identified. Although the content could be broadly organised, there was no consensus on the content and format of physical activity PRO questionnaires in elderly and chronically ill populations. Nevertheless, this systematic review will help investigators to select a physical activity PRO questionnaire that best serves their research question and context. PMID:22414164

  8. Outcome in pediatric hydrocephalus: a comparison between previously used outcome measures and the hydrocephalus outcome questionnaire.

    PubMed

    Platenkamp, Marc; Hanlo, Patrick W; Fischer, Kathelijn; Gooskens, Rob H J M

    2007-07-01

    The objectives of this study were to assess, in a cohort of children with recently treated hydrocephalus, the correlation between scores on the Hydrocephalus Outcome Questionnaire (HOQ) and the children's type of schooling and motor functioning, and to assess the overall outcome of the children. The health status of 142 pediatric patients (85 boys) with previous hydrocephalus, born between 1995 and 1999, was assessed. Outcomes were determined using the HOQ, type of schooling, and motor functioning. Data were obtained from parental interviews and patient medical records. RESULTS. Twelve patients died (8.5%). Responses to the HOQ were obtained from 107 patients (65 boys). The mean age of the patients was 7 years and 9 months +/- 1.42 years (range 6-10 years). The Physical Health score of the HOQ correlated well with the motor functioning score (r = 0.652) as did the Cognitive Health score with the type of schooling (r = 0.672). Fifty-nine percent of the patients were able to attend a school for students with normal intelligence. Disabling motor functioning was found in only 30% of patients. Epilepsy was present in 14%. The results show a good correlation between the type of schooling and the Cognitive HOQ score and between the Physical HOQ score and the motor functioning score. The HOQ is a simple and very useful measurement for determining outcome in pediatric hydrocephalus.

  9. Patient reported outcome measures in male incontinence surgery.

    PubMed

    Tran, M G B; Yip, J; Uveili, K; Biers, S M; Thiruchelvam, N

    2014-10-01

    Patient reported outcome measures (PROMs) were used to evaluate outcomes of the artificial urinary sphincter (AUS) and the AdVance™ (American Medical Systems, Minnetonka, MN, US) male sling system (AVMS) for the symptomatic management of male stress urinary incontinence. All male patients with stress urinary incontinence referred to our specialist clinic over a two-year period completed the ICIQ-UI SF (International Consultation on Incontinence Questionnaire on Urinary Incontinence Short Form) and the ICIQ-MLUTS LF (International Consultation on Incontinence Questionnaire on Male Lower Urinary Tract Symptoms Long Form) at consultation as well as at subsequent follow-up appointments. The Wilcoxon signed-rank test for non-parametric paired data was used for pre and postoperative comparisons. The chi-squared test was used for categorical variables. Thirty-seven patients (forty surgical cases) completed a preoperative and at least one follow-up questionnaire. There was a statistically significant improvement in PROMs postoperatively, regardless of mode of surgery (p<0.01). Analysis of the ICIQ-MLUTS LF showed that patients with higher preoperative scores (>25) had greater improvement with an AUS than with the AVMS (p<0.01). This prospective study shows that completion and collection of PROMs as part of routine clinical practice is achievable and useful in the assessment of male stress incontinence surgery. PROMs are important instruments to assess effectiveness of healthcare intervention and they are useful adjuncts in surgical studies.

  10. Workplace bullying in the UK NHS: a questionnaire and interview study on prevalence, impact and barriers to reporting

    PubMed Central

    Carter, Madeline; Thompson, Neill; Crampton, Paul; Morrow, Gill; Burford, Bryan; Gray, Christopher; Illing, Jan

    2013-01-01

    Objectives To examine the prevalence and impact of bullying behaviours between staff in the National Health Service (NHS) workplace, and to explore the barriers to reporting bullying. Design Cross-sectional questionnaire and semi-structured interview. Setting 7 NHS trusts in the North East of England. Participants 2950 NHS staff, of whom 43 took part in a telephone interview. Main outcome measures Prevalence of bullying was measured by the revised Negative Acts Questionnaire (NAQ-R) and the impact of bullying was measured using indicators of psychological distress (General Health Questionnaire, GHQ-12), intentions to leave work, job satisfaction and self-reported sickness absence. Barriers to reporting bullying and sources of bullying were also examined. Results Overall, 20% of staff reported having been bullied by other staff to some degree and 43% reported having witnessed bullying in the last 6 months. Male staff and staff with disabilities reported higher levels of bullying. There were no overall differences due to ethnicity, but some differences were detected on several negative behaviours. Bullying and witnessing bullying were associated with lower levels of psychological health and job satisfaction, and higher levels of intention to leave work. Managers were the most common source of bullying. Main barriers to reporting bullying were the perception that nothing would change, not wanting to be seen as a trouble-maker, the seniority of the bully and uncertainty over how policies would be implemented and bullying cases managed. Data from qualitative interviews supported these findings and identified workload pressures and organisational culture as factors contributing to workplace bullying. Conclusions Bullying is a persistent problem in healthcare organisations which has significant negative outcomes for individuals and organisations.

  11. 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

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

    PubMed

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

    2014-12-01

    This systematic review investigated the measurement properties of disease-specific patient-reported outcome measures used in Patellofemoral Pain Syndrome. Two independent reviewers conducted a systematic search of key databases (MEDLINE, EMBASE, AMED, CINHAL+ and the Cochrane Library from inception to August 2013) to identify relevant studies. A third reviewer mediated in the event of disagreement. Methodological quality was evaluated using the validated COSMIN (Consensus-based Standards for the Selection of Health Measurement Instruments) tool. Data synthesis across studies determined the level of evidence for each patient-reported outcome measure. The search strategy returned 2177 citations. Following the eligibility review phase, seven studies, evaluating twelve different patient-reported outcome measures, met inclusion criteria. A 'moderate' level of evidence supported the structural validity of several measures: the Flandry Questionnaire, Anterior Knee Pain Scale, Functional Index Questionnaire, Eng and Pierrynowski Questionnaire and Visual Analogue Scales for 'usual' and 'worst' pain. In addition, there was a 'Limited' level of evidence supporting the test-retest reliability and validity (cross-cultural, hypothesis testing) of the Persian version of the Anterior Knee Pain Scale. Other measurement properties were evaluated with poor methodological quality, and many properties were not evaluated in any of the included papers. Current disease-specific outcome measures for Patellofemoral Pain Syndrome require further investigation. Future studies should evaluate all important measurement properties, utilising an appropriate framework such as COSMIN to guide study design, to facilitate optimal methodological quality. Copyright © 2014 Elsevier Ltd. All rights reserved.

  13. Content Validity of the Hypogonadism Impact of Symptoms Questionnaire (HIS-Q): A Patient-Reported Outcome Measure to Evaluate Symptoms of Hypogonadism.

    PubMed

    Gelhorn, Heather L; Vernon, Margaret K; Stewart, Katie D; Miller, Michael G; Brod, Meryl; Althof, Stanley E; DeRogatis, Leonard R; Dobs, Adrian; Seftel, Allen D; Revicki, Dennis A

    2016-04-01

    Hypogonadism, or low testosterone, is a common disorder. There are currently no patient-reported outcome (PRO) instruments designed to comprehensively evaluate the symptoms of hypogonadism and to detect changes in these symptoms in response to treatment. The purpose of this study was to develop a PRO instrument, the Hypogonadism Impact of Symptoms Questionnaire (HIS-Q) and to assess its content validity. A literature review, expert clinician input, and qualitative concept elicitation with 39 male hypogonadism patients (four focus groups: n = 25; individual interviews: n = 14; mean age 52.3 ± 14.3 years) from the USA were used to develop the draft HIS-Q. Subsequent cognitive interviews (n = 29; mean age 51.5 ± 15.4 years) were used to evaluate content validity. Emergent discussion with participants yielded symptoms within the sexual, physical, energy, sleep, cognition, and mood domains. Low libido and tiredness were most commonly reported. The initial version of the HIS-Q includes 53 items that were consistently understood by the participants, who found the instrument to be relevant to their experiences with hypogonadism and comprehensive in the content coverage of symptoms. The HIS-Q is a comprehensive PRO measure of hypogonadism symptom severity in males. Its design elements, including the response options and recall period, were suitable, and content validity was confirmed.

  14. Somatic outcome among patients hospitalised for anorexia nervosa in adolescence: disorders reported and links with global outcome.

    PubMed

    Roux, Hélène; Blanchet, Corinne; Stheneur, Chantal; Chapelon, Emeline; Godart, Nathalie

    2013-06-01

    (1) To describe the frequency of somatic pathologies and depression among former anorexia nervosa (AN) patients; (2) to study links with subjects' clinical history and global outcomes. 97 women hospitalised for AN during adolescence, 9.00 ± 1.92 years previously, were interviewed using structured questionnaires concerning somatic and psychiatric disorders that they had experienced. Iron deficiency, migraine, cystitis, upper digestive system disorders, fractures, osteoporosis, and dental problems were reported with a frequency >20 %. Depression was reported by 2/3 of the sample. Osteoporosis was 14 times more frequent in case of vitamin D deficiency. Fractures were three times more frequent in presence of osteoporosis and less frequent when the overall outcome was better. Among women who had AN in adolescence, somatic comorbidities are frequent in adulthood. They are linked to the severity and the duration of AN, and to the overall outcome of the subject.

  15. The impact of an electronic health questionnaire on symptom management and behavior reporting for breast cancer survivors.

    PubMed

    Bock, Meredith; Moore, Dan; Hwang, Jimmy; Shumay, Dianne; Lawson, Laurell; Hamolsky, Deborah; Esserman, Laura; Rugo, Hope; Chien, A Jo; Park, John; Munster, Pamela; Melisko, Michelle

    2012-08-01

    Breast cancer (BC) patients experience multiple symptoms as a result of diagnosis and treatment. While surveillance for detecting cancer recurrence is fundamental to follow-up care, managing symptoms, and promoting health behaviors are equally important. UCSF has implemented a secure online health questionnaire enabling BC patients to provide updates of their health history and symptoms. We randomly selected a sample of stage I-III BC patients (n = 106) who completed a questionnaire before a medical oncology visit between August 2010 and January 2011 and consented to have data used for research. We conducted a chart review calculating the number of symptoms reported in the questionnaire, the clinic note only, and both questionnaire and clinic note, excluding chronic symptoms addressed previously. Self-reported data on exercise and alcohol consumption was compared to documentation of these lifestyle factors in clinic notes. Patients reported significantly more symptoms using the online questionnaire (mean = 3.8, range 0-13) than were documented by the provider in clinic notes (mean = 1.8, range 0-7; p < 0.001 for the difference). A regression plot comparing the percentage of symptoms agreed upon by the patient and provider and the percentage of symptoms addressed yields a slope of 0.56 (95 % CI 0.41-0.71). The number of self-reported symptoms correlates with self-reported Karnofsky scale such that the number of symptoms reported by the patient increases linearly with this score until a threshold and it then plateaus (p < 0.001). Exercise behavior and alcohol consumption were reported in 100 % of the online questionnaires, but was documented in only 30/106 (28 %) and 75/106 (70 %) of charts reviewed. In 19/75 (25 %) charts with alcohol consumption documented, there was substantial discordance between patient and clinician reporting. Electronic data collection of BC patient-reported outcomes has a positive effect on symptom management and identification of

  16. Predictors of nonresponse in a questionnaire-based outcome study of vocational rehabilitation patients.

    PubMed

    Burrus, Cyrille; Ballabeni, Pierluigi; Deriaz, Olivier; Gobelet, Charles; Luthi, François

    2009-09-01

    To identify predictors of nonresponse to a self-report study of patients with orthopedic trauma hospitalized for vocational rehabilitation between November 15, 2003, and December 31, 2005. The role of biopsychosocial complexity, assessed using the INTERMED, was of particular interest. Cohort study. Questionnaires with quality of life, sociodemographic, and job-related questions were given to patients at hospitalization and 1 year after discharge. Sociodemographic data, biopsychosocial complexity, and presence of comorbidity were available at hospitalization (baseline) for all eligible patients. Logistic regression models were used to test a number of baseline variables as potential predictors of nonresponse to the questionnaires at each of the 2 time points. Rehabilitation clinic. Patients (N=990) hospitalized for vocational rehabilitation over a period of 2 years. Not applicable. Nonresponse to the questionnaires was the binary dependent variable. Patients with high biopsychosocial complexity, foreign native language, or low educational level were less likely to respond at both time points. Younger patients were less likely to respond at 1 year. Those living in a stable partnership were less likely than singles to respond at hospitalization. Sex, psychiatric, and somatic comorbidity and alcoholism were never associated with nonresponse. We stress the importance of assessing biopsychosocial complexity to predict nonresponse. Furthermore, the factors we found to be predictive of nonresponse are also known to influence treatment outcome and vocational rehabilitation. Therefore, it is important to increase the response rate of the groups of concern in order to reduce selection bias in epidemiologic investigations.

  17. The Relation of the Response Distribution to Self-Report Questionnaire Items and Cognitive Ability among School-Aged Children

    ERIC Educational Resources Information Center

    Stapleton, Laura M.; Reiner, Laura S.; Aluvathingal, Anu J.

    2010-01-01

    This proposed research is part of an on-going line of research of developing questionnaire instruments for use at the elementary school level. Because field trials often use child self-report as outcome measures and sometimes determine implementation fidelity using such measures, evaluation of the validity of the use of such measures with…

  18. A telephone questionnaire in order to assess functional outcome after post-traumatic limb salvage surgery: Development and preliminary validation.

    PubMed

    Wulterkens, Leonie; Aurégan, Jean-Charles; Letellier, Thomas; Mebtouche, Nasser; Levante, Stéphane; Cottin, Philippe; Bégué, Thierry

    2015-12-01

    Post-traumatic limb salvage surgery is challenging and evaluation of the results remains arduous. No questionnaire specifically assessing functional outcome after post-traumatic limb salvage surgery of the lower extremity exists. Due to regionalization of specialized care, the patients' travel time to the hospital increases. To overcome a higher patients' travel burden, patients' follow up by telephone is an option. We aimed to develop a telephone questionnaire in order to assess functional outcome after post-traumatic limb salvage surgery of the lower extremity. From a review of scores of functional assessment of the lower limb surgery, we have developed a telephone questionnaire. A prospective study was performed to validate this telephone questionnaire. Twenty patients were included. The participants were called to complete the telephone questionnaire twice with an interval of a week. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was completed during the second telephone call. The internal consistency was analyzed by the Cronbach's alpha (α). With the outcome scores of both completions, the test-retest reliability was analyzed by the interclass correlation coefficient (ICC) 2,k with a 95% confidence interval (95% CI). The outcome scores of the second telephone questionnaire and the WOMAC questionnaire were used for the construct validity analysis by the Spearman's rank correlation coefficient (r(s)) with a 95% CI. The internal consistency analysis revealed a α=0.62 which improved to α=0.92 after removing one question from the telephone questionnaire. The final version of the telephone questionnaire comprises 32 questions, divided in 3 subscales: function, daily life and psychology. The total score varies between 0 and 86 points. The test-retest reliability was ICC 2,k=0.93 (95% CI: 0.82-0.97) and the construct validity was r(s)=0.92 (95% CI: 0.81-0.97). We present a specific telephone questionnaire in order to assess functional

  19. Measuring Resource Utilization: A Systematic Review of Validated Self-Reported Questionnaires.

    PubMed

    Leggett, Laura E; Khadaroo, Rachel G; Holroyd-Leduc, Jayna; Lorenzetti, Diane L; Hanson, Heather; Wagg, Adrian; Padwal, Raj; Clement, Fiona

    2016-03-01

    A variety of methods may be used to obtain costing data. Although administrative data are most commonly used, the data available in these datasets are often limited. An alternative method of obtaining costing is through self-reported questionnaires. Currently, there are no systematic reviews that summarize self-reported resource utilization instruments from the published literature.The aim of the study was to identify validated self-report healthcare resource use instruments and to map their attributes.A systematic review was conducted. The search identified articles using terms like "healthcare utilization" and "questionnaire." All abstracts and full texts were considered in duplicate. For inclusion, studies had to assess the validity of a self-reported resource use questionnaire, to report original data, include adult populations, and the questionnaire had to be publically available. Data such as type of resource utilization assessed by each questionnaire, and validation findings were extracted from each study.In all, 2343 unique citations were retrieved; 2297 were excluded during abstract review. Forty-six studies were reviewed in full text, and 15 studies were included in this systematic review. Six assessed resource utilization of patients with chronic conditions; 5 assessed mental health service utilization; 3 assessed resource utilization by a general population; and 1 assessed utilization in older populations. The most frequently measured resources included visits to general practitioners and inpatient stays; nonmedical resources were least frequently measured. Self-reported questionnaires on resource utilization had good agreement with administrative data, although, visits to general practitioners, outpatient days, and nurse visits had poorer agreement.Self-reported questionnaires are a valid method of collecting data on healthcare resource utilization.

  20. Integrating Patient Reported Outcomes With Clinical Cancer Registry Data: A Feasibility Study of the Electronic Patient-Reported Outcomes From Cancer Survivors (ePOCS) System

    PubMed Central

    Jones, Helen; Thomas, James; Newsham, Alex; Downing, Amy; Morris, Eva; Brown, Julia; Velikova, Galina; Forman, David; Wright, Penny

    2013-01-01

    Background Routine measurement of Patient Reported Outcomes (PROs) linked with clinical data across the patient pathway is increasingly important for informing future care planning. The innovative electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) system was developed to integrate PROs, collected online at specified post-diagnostic time-points, with clinical and treatment data in cancer registries. Objective This study tested the technical and clinical feasibility of ePOCS by running the system with a sample of potentially curable breast, colorectal, and prostate cancer patients in their first 15 months post diagnosis. Methods Patients completed questionnaires comprising multiple Patient Reported Outcome Measures (PROMs) via ePOCS within 6 months (T1), and at 9 (T2) and 15 (T3) months, post diagnosis. Feasibility outcomes included system informatics performance, patient recruitment, retention, representativeness and questionnaire completion (response rate), patient feedback, and administration burden involved in running the system. Results ePOCS ran efficiently with few technical problems. Patient participation was 55.21% (636/1152) overall, although varied by approach mode, and was considerably higher among patients approached face-to-face (61.4%, 490/798) than by telephone (48.8%, 21/43) or letter (41.0%, 125/305). Older and less affluent patients were less likely to join (both P<.001). Most non-consenters (71.1%, 234/329) cited information technology reasons (ie, difficulty using a computer). Questionnaires were fully or partially completed by 85.1% (541/636) of invited participants at T1 (80 questions total), 70.0% (442/631) at T2 (102-108 questions), and 66.3% (414/624) at T3 (148-154 questions), and fully completed at all three time-points by 57.6% (344/597) of participants. Reminders (mainly via email) effectively prompted responses. The PROs were successfully linked with cancer registry data for 100% of patients (N=636). Participant feedback

  1. Patients reported outcome post-cochlear implantation: how severe is their dizziness?

    PubMed

    Zawawi, Faisal; Alobaid, Faisal; Leroux, Tony; Zeitouni, Anthony G

    2014-01-01

    The reported prevalence of vestibular dysfunction after cochlear implantation (CI) is varies between different scientific papers. The aim of this study is to determine the reported post-implantation outcome in terms of dizziness, and to measure its impact on quality of life using the Dizziness handicap inventory (DHI). This was a prospective questionnaire based study of postoperative cochlear implant patients. The questionnaire assessed the type and onset of dizziness in addition to the DHI. 122 patients were recruited in this study, which is the largest sample size in the literature reported so far. Dizziness was evident in 45.9% of the population post-CI and in 27% pre-CI. The commonest subtype of the dizziness was unsteadiness followed by lightheadedness. The dizziness was mild in most of the patients. Although mild, dizziness is a common complaint post-cochlear implantation. An understanding of symptoms helps counsel patients preoperatively.

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

    PubMed

    Donovan, J L; Hamdy, F C; Lane, J A; Mason, M; Metcalfe, C; Walsh, E; Blazeby, J M; Peters, T J; Holding, P; Bonnington, S; Lennon, T; Bradshaw, L; Cooper, D; Herbert, P; Howson, J; Jones, A; Lyons, N; Salter, E; Thompson, P; Tidball, S; Blaikie, J; Gray, C; Bollina, P; Catto, J; Doble, A; Doherty, A; Gillatt, D; Kockelbergh, R; Kynaston, H; Paul, A; Powell, P; Prescott, S; Rosario, D J; Rowe, E; Davis, M; Turner, E L; Martin, R M; Neal, D E

    2016-10-13

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

  3. Building a Patient-Reported Outcome Metric Database: One Hospital's Experience.

    PubMed

    Rana, Adam J

    2016-06-01

    A number of provisions exist within the Patient Protection and Affordable Care Act that focus on improving the delivery of health care in the United States, including quality of care. From a total joint arthroplasty perspective, the issue of quality increasingly refers to quantifying patient-reported outcome metrics (PROMs). This article describes one hospital's experience in building and maintaining an electronic PROM database for a practice of 6 board-certified orthopedic surgeons. The surgeons advocated to and worked with the hospital to contract with a joint registry database company and hire a research assistant. They implemented a standardized process for all surgical patients to fill out patient-reported outcome questionnaires at designated intervals. To date, the group has collected patient-reported outcome metric data for >4500 cases. The data are frequently used in different venues at the hospital including orthopedic quality metric and research meetings. In addition, the results were used to develop an annual outcome report. The annual report is given to patients and primary care providers, and portions of it are being used in discussions with insurance carriers. Building an electronic database to collect PROMs is a group undertaking and requires a physician champion. A considerable amount of work needs to be done up front to make its introduction a success. Once established, a PROM database can provide a significant amount of information and data that can be effectively used in multiple capacities. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. Assessing subjective memory complaints: a comparison of spontaneous reports and structured questionnaire methods.

    PubMed

    Burmester, Bridget; Leathem, Janet; Merrick, Paul

    2015-01-01

    Subjective memory complaints (SMCs) are a common occurrence for adults, which increase with age, and cause considerable distress. Traditionally SMCs have been assessed by either questionnaires, which ask whether a person has experienced given examples of SMCs, or open-ended questions which elicit spontaneous reports of SMCs. However, little is known about how these methods of assessment might influence reporting of SMCs. Four hundred and twenty one adults aged 40 years and above were surveyed about SMCs using spontaneous report and questionnaire methods. As expected, spontaneously reported SMCs were fewer in number and rated more distressing overall than SMCs endorsed on a questionnaire. However, comparison of individual SMCs revealed that distress ratings tended to be higher when assessed in a questionnaire than spontaneously reported, which may be due to the context of a questionnaire causing inflated ratings. Participants also reported SMCs which were not well assessed by the questionnaire, including some which were among the most distressing SMCs overall. Conversely, other SMCs were over-sampled by the questionnaire and did not feature in spontaneous reports. Implications for clinical assessment of SMCs are that open-ended questioning might be preferable to initial use of prescriptive questionnaires, in order to elicit SMCs that are most distressing. While use of questionnaires may reveal endorsement of a wider range of SMCs than are spontaneously reported, they can take focus away from, or even fail to assess, those SMCs which cause most subjective distress (and therefore should be the target of interventions).

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

    PubMed

    Ni Riordain, R; McCreary, C

    2013-04-01

    Oral Diseases (2013) 19, 230-235 This review aims to investigate the patient-reported outcomes currently used in the burning mouth syndrome literature and to explore whether any standardisation of such measures has taken place. Electronic databases were searched for all types of burning mouth syndrome studies using patient-reported outcome measures. Studies were selected by predefined inclusion criteria. Copies of the papers obtained were thoroughly reviewed. A study-specific data extraction form was used, allowing papers to be reviewed in a standardised manner. The initial literature search yielded a total of 173 citations, 43 of which were deemed suitable for inclusion in this study. Symptom severity and symptomatic relief were reported as a patient-reported outcome measure in 40 of the studies and quantified most commonly using a visual analogue scale. Quality of life was reported in 13 studies included in this review. Depression and/or anxiety was reported in 14 of the studies. As is evident from the variety of questionnaires and instruments used in the evaluation of the impact of burning mouth syndrome on patients' lives, no standardisation of patient outcomes has yet been achieved. © 2012 John Wiley & Sons A/S.

  6. Clinical and Patient-reported Outcomes of 1-sided Anterior Urethroplasty for Long-segment or Panurethral Strictures.

    PubMed

    Spencer, Jeffrey; Blakely, Stephen; Daugherty, Michael; Angulo, Javier C; Martins, Francisco; Venkatesan, Krishnan; Nikolavsky, Dmitriy

    2018-01-01

    To evaluate clinical and patient-reported urinary and sexual outcomes after a long-segment stricture repair using the 1-sided urethral dissection, penile invagination, and dorsal buccal mucosa graft onlay technique described by Kulkarni et al. Patients from 4 institutions after single-stage repairs for long-segment urethral strictures (>8 cm) from January 2002 to April 2016 were reviewed. Technique described by Kulkarni et al was used in all cases. Clinical outcomes included uroflowmetry (Qmax) and post-void residuals. Patient-reported outcome measures included International Prostate Symptom Score survey, Sexual Health Inventory for Men, Male Sexual Health Questionnaire, and Global Response Assessment questionnaire to measure voiding, sexual, ejaculatory symptoms, and overall improvement, respectively. Seventy-three patients with a minimum of 12 months' follow-up were included. The mean age and stricture length were 56 (21-80) years and 13.6 (8-21) cm, respectively. At a mean follow-up of 44 (12-162) months, 9 of 73 (12%) strictures recurred. The mean baseline International Prostate Symptom Score of 23 (7-24) decreased to 10 (1-17) on follow-up (P <.001). Eight of 42 patients (21.4%) reported an increase, and 6 of 42 patients (14.3%) decreased in Sexual Health Inventory for Men following urethroplasty. Ejaculatory function on Male Sexual Health Questionnaire improved after urethroplasty from 8 preoperatively to 11 postoperatively (P <.004). All patients reported improvement after urethroplasty on Global Response Assessment questionnaire. Post-void dribbling and chordee occurred in 45% and 25% of patients, respectively. Durable patency in most patients is demonstrated in this study. PROMs indicate an improvement in urinary function and moderate effect on sexual function. Transient penile chordee was evident in 25% of patients. Copyright © 2017 Elsevier Inc. All rights reserved.

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

    PubMed Central

    Paterson, Charlotte

    2006-01-01

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

  8. 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. (c) 2016 APA, all rights reserved).

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

    PubMed

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

    2004-04-01

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

  10. [Measurement properties of self-report questionnaires published in Korean nursing journals].

    PubMed

    Lee, Eun-Hyun; Kim, Chun-Ja; Kim, Eun Jung; Chae, Hyun-Ju; Cho, Soo-Yeon

    2013-02-01

    The purpose of this study was to evaluate measurement properties of self-report questionnaires for studies published in Korean nursing journals. Of 424 Korean nursing articles initially identified, 168 articles met the inclusion criteria. The methodological quality of the measurements used in the studies and interpretability were assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. It consists of items on internal consistency, reliability, measurement error, content validity, construct validity including structural validity, hypothesis testing, cross-cultural validity, and criterion validity, and responsiveness. For each item of the COSMIN checklist, measurement properties are rated on a four-point scale: excellent, good, fair, and poor. Each measurement property is scored with worst score counts. All articles used the classical test theory for measurement properties. Internal consistency (72.6%), construct validity (56.5%), and content validity (38.2%) were most frequently reported properties being rated as 'excellent' by COSMIN checklist, whereas other measurement properties were rarely reported. A systematic review of measurement properties including interpretability of most instruments warrants further research and nursing-focused checklists assessing measurement properties should be developed to facilitate intervention outcomes across Korean studies.

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

    PubMed Central

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

    2017-01-01

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

  12. Psychometric Properties of Questionnaires on Functional Health Status in Oropharyngeal Dysphagia: A Systematic Literature Review

    PubMed Central

    Speyer, Renée; Cordier, Reinie; Kertscher, Berit; Heijnen, Bas J

    2014-01-01

    Introduction. Questionnaires on Functional Health Status (FHS) are part of the assessment of oropharyngeal dysphagia. Objective. To conduct a systematic review of the literature on the psychometric properties of English-language FHS questionnaires in adults with oropharyngeal dysphagia. Methods. A systematic search was performed using the electronic databases Pubmed and Embase. The psychometric properties of the questionnaires were determined based on the COSMIN taxonomy of measurement properties and definitions for health-related patient-reported outcomes and the COSMIN checklist using preset psychometric criteria. Results. Three questionnaires were included: the Eating Assessment Tool (EAT-10), the Swallowing Outcome after Laryngectomy (SOAL), and the Self-report Symptom Inventory. The Sydney Swallow Questionnaire (SSQ) proved to be identical to the Modified Self-report Symptom Inventory. All FHS questionnaires obtained poor overall methodological quality scores for most measurement properties. Conclusions. The retrieved FHS questionnaires need psychometric reevaluation; if the overall methodological quality shows satisfactory improvement on most measurement properties, the use of the questionnaires in daily clinic and research can be justified. However, in case of insufficient validity and/or reliability scores, new FHS questionnaires need to be developed using and reporting on preestablished psychometric criteria as recommended in literature. PMID:24877095

  13. An exploratory study of whether pregnancy outcomes influence maternal self-reported history of child maltreatment.

    PubMed

    Cammack, Alison L; Hogue, Carol J; Drews-Botsch, Carolyn D; Kramer, Michael R; Pearce, Brad D; Knight, Bettina; Stowe, Zachary N; Newport, D Jeffrey

    2018-02-22

    Childhood maltreatment is common and has been increasingly studied in relation to perinatal outcomes. While retrospective self-report is convenient to use in studies assessing the impact of maltreatment on perinatal outcomes, it may be vulnerable to bias. We assessed bias in reporting of maltreatment with respect to women's experiences of adverse perinatal outcomes in a cohort of 230 women enrolled in studies of maternal mental illness. Each woman provided a self-reported history of childhood maltreatment via the Childhood Trauma Questionnaire at two time points: 1) the preconception or prenatal period and 2) the postpartum period. While most women's reports of maltreatment agreed, there was less agreement for physical neglect among women experiencing adverse perinatal outcomes. Further, among women who discrepantly reported maltreatment, those experiencing adverse pregnancy outcomes tended to report physical neglect after delivery but not before, and associations between physical neglect measured after delivery and adverse pregnancy outcomes were larger than associations that assessed physical neglect before delivery. There were larger associations between post-delivery measured maltreatment and perinatal outcomes among women who had not previously been pregnant and in those with higher postpartum depressive symptoms. Although additional larger studies in the general population are necessary to replicate these findings, they suggest retrospective reporting of childhood maltreatment, namely physical neglect, may be prone to systematic differential recall bias with respect to perinatal outcomes. Measures of childhood maltreatment reported before delivery may be needed to validly estimate associations between maternal exposure to childhood physical neglect and perinatal outcomes. Copyright © 2018 Elsevier Ltd. All rights reserved.

  14. Day-to-day measurement of patient-reported outcomes in exacerbations of chronic obstructive pulmonary disease

    PubMed Central

    Kocks, Jan Willem H; van den Berg, Jan Willem K; Kerstjens, Huib AM; Uil, Steven M; Vonk, Judith M; de Jong, Ynze P; Tsiligianni, Ioanna G; van der Molen, Thys

    2013-01-01

    Background Exacerbations of chronic obstructive pulmonary disease (COPD) are a major burden to patients and to society. Little is known about the possible role of day-to-day patient-reported outcomes during an exacerbation. This study aims to describe the day-to-day course of patient-reported health status during exacerbations of COPD and to assess its value in predicting clinical outcomes. Methods Data from two randomized controlled COPD exacerbation trials (n = 210 and n = 45 patients) were used to describe both the feasibility of daily collection of and the day-to-day course of patient-reported outcomes during outpatient treatment or admission to hospital. In addition to clinical parameters, the BORG dyspnea score, the Clinical COPD Questionnaire (CCQ), and the St George’s Respiratory Questionnaire were used in Cox regression models to predict treatment failure, time to next exacerbation, and mortality in the hospital study. Results All patient-reported outcomes showed a distinct pattern of improvement. In the multivariate models, absence of improvement in CCQ symptom score and impaired lung function were independent predictors of treatment failure. Health status and gender predicted time to next exacerbation. Five-year mortality was predicted by age, forced expiratory flow in one second % predicted, smoking status, and CCQ score. In outpatient management of exacerbations, health status was found to be less impaired than in hospitalized patients, while the rate and pattern of recovery was remarkably similar. Conclusion Daily health status measurements were found to predict treatment failure, which could help decision-making for patients hospitalized due to an exacerbation of COPD. PMID:23766644

  15. Effect of telehealth on quality of life and psychological outcomes over 12 months (Whole Systems Demonstrator telehealth questionnaire study): nested study of patient reported outcomes in a pragmatic, cluster randomised controlled trial.

    PubMed

    Cartwright, Martin; Hirani, Shashivadan P; Rixon, Lorna; Beynon, Michelle; Doll, Helen; Bower, Peter; Bardsley, Martin; Steventon, Adam; Knapp, Martin; Henderson, Catherine; Rogers, Anne; Sanders, Caroline; Fitzpatrick, Ray; Barlow, James; Newman, Stanton P

    2013-02-26

    To assess the effect of second generation, home based telehealth on health related quality of life, anxiety, and depressive symptoms over 12 months in patients with long term conditions. A study of patient reported outcomes (the Whole Systems Demonstrator telehealth questionnaire study; baseline n=1573) was nested in a pragmatic, cluster randomised trial of telehealth (the Whole Systems Demonstrator telehealth trial, n=3230). General practice was the unit of randomisation, and telehealth was compared with usual care. Data were collected at baseline, four months (short term), and 12 months (long term). Primary intention to treat analyses tested treatment effectiveness; multilevel models controlled for clustering by general practice and a range of covariates. Analyses were conducted for 759 participants who completed questionnaire measures at all three time points (complete case cohort) and 1201 who completed the baseline assessment plus at least one other assessment (available case cohort). Secondary per protocol analyses tested treatment efficacy and included 633 and 1108 participants in the complete case and available case cohorts, respectively. Provision of primary and secondary care via general practices, specialist nurses, and hospital clinics in three diverse regions of England (Cornwall, Kent, and Newham), with established integrated health and social care systems. Patients with chronic obstructive pulmonary disease (COPD), diabetes, or heart failure recruited between May 2008 and December 2009. Generic, health related quality of life (assessed by physical and mental health component scores of the SF-12, and the EQ-5D), anxiety (assessed by the six item Brief State-Trait Anxiety Inventory), and depressive symptoms (assessed by the 10 item Centre for Epidemiological Studies Depression Scale). In the intention to treat analyses, differences between treatment groups were small and non-significant for all outcomes in the complete case (0.480 ≤ P ≤ 0.904) or

  16. A new psychometric questionnaire for reporting of somatosensory percepts

    NASA Astrophysics Data System (ADS)

    Kim, L. H.; McLeod, R. S.; Kiss, Z. H. T.

    2018-02-01

    Objective. There have been remarkable advances over the past decade in neural prostheses to restore lost motor function. However, restoration of somatosensory feedback, which is essential for fine motor control and user acceptance, has lagged behind. With an increasing interest in using electrical stimulation to restore somatosensory sensations within the peripheral (PNS) and central nervous systems (CNS), it is critical to characterize the percepts evoked by electrical stimulation in a standardized manner with a validated psychometric questionnaire. This will allow comparison of results from applications at various nervous system levels in multiple settings. Approach. We compiled a summary of published reports of somatosensory percepts that were elicited by electrical stimulation in humans and used these to develop a new psychometric questionnaire. Results. This new questionnaire was able to characterize subjective evoked sensations with good test-retest reliability (Spearman’s correlation coefficients ranging 0.716  ⩽  ρ  ⩽  1.000, p  ⩽  0.005) in 13 subjects receiving stimulation through neural implants in both the CNS and PNS. Furthermore, the new questionnaire captured more descriptors (M  =  2.65, SD  =  0.91) that would have been missed by being categorized as ‘other sensations’, using a previous questionnaire (M  =  1.40, SD  =  0.77, t(12)  =  -10.24, p  <  0.001). Lastly, the new questionnaire was able to capture different descriptors within subjects using different patterns of electrical stimulation (Wilk’s Lambda  =  0.42, F(3, 10)  =  4.58, p  =  0.029). Significance. This new somatosensory psychometric questionnaire will aid in establishing consistency and standardization of reporting in future studies of somatosensory neural prostheses.

  17. Development of an Encompassing Questionnaire for Evaluating the Outcomes Following Total Knee Arthroplasty.

    PubMed

    Chughtai, Morad; Khlopas, Anton; Thomas, Melbin; Gwam, Chukwuweike U; Jauregui, Julio J; Elmallah, Randa K; Roche, Martin; Delanois, Ronald E

    2017-01-10

    There are many standardized scales and questionnaires used to evaluate TKA patients; however, individually they do not always assess patients adequately. Consequently, many are used in combinations to provide a thorough evaluation. However, this leads to redundancy, confusion, and an excessive patient time-burden. Therefore, the purpose of this study was to develop a usable combined knee questionnaire that combines questions in a non-redundant manner. Specifically, we aimed to: 1) create a combined knee questionnaire that encompasses questions from multiple systems, while eliminating redundancy; 2) correlate the new system with the existing validated questionnaires; and 3) determine the length of time it takes to administer this new questionnaire. In a previous study, it was determined that the six most commonly cited validated systems to assess the knee were the: Knee Society Score (KSS), The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Knee injury and Osteoarthritis Outcome Score (KOOS), Lower Extremity Functional Scale (LEFS), Activity Rating Scale (ARS), and Short-Form-36 (SF-36). Therefore, we ensured that the new questionnaire encompassed all elements of these systems. After development of the combined questionnaire, we co-administered it to 20 subjects alongside the above validated questionnaires. We then transposed the corresponding answers from the combined questionnaire to each selected validated system to perform an intra-class correlation analysis. In addition, we recorded the length of time it took to administer the new questionnaire and compared it to the time it took to administer the individual validated questionnaires. Intra-class correlation analysis demonstrated statistically significant positive correlations between the KSS, WOMAC, KOOS, LEFS, ARS, SF-36, and the corresponding questions in the combined questionnaire. The mean length of time it took to administer the combined questionnaire (mean, 10.1 minutes, range, 6.6 to

  18. A Psychometric Evaluation of the Anatomy Learning Experiences Questionnaire and Correlations with Learning Outcomes

    ERIC Educational Resources Information Center

    Choi-Lundberg, Derek L.; Williams, Anne-Marie M.; Zimitat, Craig

    2017-01-01

    The Anatomy Learning Experiences Questionnaire (ALEQ) was designed by Smith and Mathias to explore students' perceptions and experiences of learning anatomy. In this study, the psychometric properties of a slightly altered 34-item ALEQ (ALEQ-34) were evaluated, and correlations with learning outcomes investigated, by surveying first- and…

  19. 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

  20. Patient reported outcome measures in septorhinoplasty surgery.

    PubMed

    Biggs, T C; Fraser, L R; Ward, M J; Sunkaraneni, V S; Harries, P G; Salib, R J

    2015-01-01

    Surgical procedures incorporating a cosmetic element such as septorhinoplasty and otoplasty are currently under threat in the National Health Service (NHS) as they are deemed to be procedures of 'limited clinical benefit' by many primary care providers. Patient reported outcome measures (PROMs), which assess the quality of care delivered from the patients' perspective, are becoming increasingly important in documenting the effectiveness of such procedures. The Rhinoplasty Outcomes Evaluation (ROE) questionnaire, a validated PROM tool, was used to assess patient satisfaction in 141 patients undergoing septorhinoplasty surgery over a 90-month period at the University Hospital Southampton NHS Foundation Trust. Overall, 100 patients with a mean follow-up period of 36 months completed the study. The mean ROE score was 73.3%. In addition, 75% of patients questioned were happy with the final result of their operation and 83% would undergo the procedure again if required. These benefits occurred irrespective of age, sex and primary versus revision surgery, and were maintained for up to 71 months following surgery. This study has shown that patients are generally satisfied with their functional and cosmetic outcomes following septorhinoplasty surgery. These results help support the case for septorhinoplasty surgery to continue being funded as an NHS procedure.

  1. Reference values for anxiety questionnaires: the Leiden Routine Outcome Monitoring Study.

    PubMed

    Schulte-van Maaren, Yvonne W M; Giltay, Erik J; van Hemert, Albert M; Zitman, Frans G; de Waal, Margot W M; Carlier, Ingrid V E

    2013-09-25

    The monitoring of patients with an anxiety disorder can benefit from Routine Outcome Monitoring (ROM). As anxiety disorders differ in phenomenology, several anxiety questionnaires are included in ROM: Brief Scale for Anxiety (BSA), PADUA Inventory Revised (PI-R), Panic Appraisal Inventory (PAI), Penn State Worry Questionnaire (PSWQ), Worry Domains Questionnaire (WDQ), Social Interaction, Anxiety Scale (SIAS), Social Phobia Scale (SPS), and the Impact of Event Scale-Revised (IES-R). We aimed to generate reference values for both 'healthy' and 'clinically anxious' populations for these anxiety questionnaires. We included 1295 subjects from the general population (ROM reference-group) and 5066 psychiatric outpatients diagnosed with a specific anxiety disorder (ROM patient-group). The MINI was used as diagnostic device in both the ROM reference group and the ROM patient group. To define limits for one-sided reference intervals (95th percentile; P95) the outermost 5% of observations were used. Receiver Operating Characteristics (ROC) analyses were used to yield alternative cut-off values for the anxiety questionnaires. For the ROM reference-group the mean age was 40.3 years (SD=12.6), and for the ROM patient-group it was 36.5 years (SD=11.9). Females constituted 62.8% of the reference-group and 64.4% of the patient-group. P95 ROM reference group cut-off values for reference versus clinically anxious populations were 11 for the BSA, 43 for the PI-R, 37 for the PAI Anticipated Panic, 47 for the PAI Perceived Consequences, 65 for the PAI Perceived Self-efficacy, 66 for the PSWQ, 74 for the WDQ, 32 for the SIAS, 19 for the SPS, and 36 for IES-R. ROC analyses yielded slightly lower reference values. The discriminative power of all eight anxiety questionnaires was very high. Substantial non-response and limited generalizability. For eight anxiety questionnaires a comprehensive set of reference values was provided. Reference values were generally higher in women than in men

  2. The Cambridge Otology Quality of Life Questionnaire: an otology-specific patient-recorded outcome measure. A paper describing the instrument design and a report of preliminary reliability and validity.

    PubMed

    Martin, T P C; Moualed, D; Paul, A; Ronan, N; Tysome, J R; Donnelly, N P; Cook, R; Axon, P R

    2015-04-01

    The Cambridge Otology Quality of Life Questionnaire (COQOL) is a patient-recorded outcome measurement (PROM) designed to quantify the quality of life of patients attending otology clinics. Item-reduction model. A systematically designed long-form version (74 items) was tested with patient focus groups before being presented to adult otology patients (n. 137). Preliminary item analysis tested reliability, reducing the COQOL to 24 questions. This was then presented in conjunction with the SF-36 (V1) questionnaire to a total of 203 patients. Subsequently, these were re-presented at T + 3 months, and patients recorded whether they felt their condition had improved, deteriorated or remained the same. Non-responders were contacted by post. A correlation between COQOL scores and patient perception of change was examined to analyse content validity. Teaching hospital and university psychology department. Adult patients attending otology clinics with a wide range of otological conditions. Item reliability measured by item–total correlation, internal consistency and test– retest reliability. Validity measured by correlation between COQOL scores and patient-reported symptom change. Reliability: the COQOL showed excellent internal consistency at both initial presentation (a = 0.90) and 3 months later (a = 0.93). Validity: One-way analysis of variance showed a significant difference between groups reporting change and those reporting no change in quality of life (F(2, 80) = 5.866, P < 0.01). The COQOL is the first otology-specific PROM. Initial studies demonstrate excellent reliability and encouraging preliminary criterion validity: further studies will allow a deeper validation of the instrument.

  3. Patient reported outcome of adult perioperative anaesthesia in the United Kingdom: a cross-sectional observational study.

    PubMed

    Walker, E M K; Bell, M; Cook, T M; Grocott, M P W; Moonesinghe, S R

    2016-06-12

    Understanding the patient perspective on healthcare is central to the evaluation of quality. This study measured selected patient-reported outcomes after anaesthesia in order to identify targets for research and quality improvement. This cross-sectional observational study in UK National Health Service hospitals, recruited adults undergoing non-obstetric surgery requiring anaesthesia care over a 48 h period. Within 24 h of surgery, patients completed the Bauer questionnaire (measuring postoperative discomfort and satisfaction with anaesthesia care), and a modified Brice questionnaire to elicit symptoms suggestive of accidental awareness during general anaesthesia (AAGA). Patient, procedural and pharmacological data were recorded to enable exploration of risk factors for these poor outcomes. 257 hospitals in 171 NHS Trusts participated (97% of eligible organisations). Baseline characteristics were collected on 16,222 patients; 15,040 (93%) completed postoperative questionnaires. Anxiety was most frequently cited as the worst aspect of the perioperative experience. Thirty-five per cent of patients reported severe discomfort in at least one domain: thirst (18.5%; 95% CI 17.8-19.1), surgical pain (11.0%; 10.5-11.5) and drowsiness (10.1%; 9.6-10.5) were most common. Despite this, only 5% reported dissatisfaction with any aspect of anaesthesia-related care. Regional anaesthesia was associated with a reduced burden of side-effects. The incidence of reported AAGA was one in 800 general anaesthetics (0.12%) Anxiety and discomfort after surgery are common; despite this, satisfaction with anaesthesia care in the UK is high. The inconsistent relationship between patient-reported outcome, patient experience and patient satisfaction supports using all three of these domains to provide a comprehensive assessment of the quality of anaesthesia care. © The Author 2016. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For

  4. Time Burden of Standardized Hip Questionnaires.

    PubMed

    Chughtai, Morad; Khlopas, Anton; Mistry, Jaydev B; Gwam, Chukwuweike U; Elmallah, Randa K; Mont, Michael A

    2016-04-01

    Many standardized scales and questionnaires have been developed to assess outcomes of patients undergoing total hip arthroplasty (THA). However, these surveys can be a burden to both patients and orthopaedists as some are time-inefficient. In addition, there is a paucity of reports assessing the time it takes to complete them. In this study we aimed to: (1) assess how long it takes to complete the most common standardized hip questionnaires; (2) determine the presence of variation in completion time; and (3) evaluate the effects of age, gender, and level of education on completion time. Based on a previous study, we selected the seven most commonly used hip scoring systems-Western Ontario and McMaster Universities Hip Outcome Assessment (WOMAC), Harris Hip Score (HHS), Hip Disability and Osteoarthritis Outcome Score (HOOS), Larson Score, Short-form 36 (SF-36), modified Merle d'Aubigne and Postel Score (MDA), and Lower Extremity Functional Scale (LEFS). The standardized scales and questionnaires were randomly administered to 70 subjects. The subjects were unaware that they were being timed during completion of the questionnaire. We obtained the coefficients of variation of time for each questionnaire. The mean time to complete the questionnaire was then stratified and compared based on age, gender, and level of education. The mean time to complete each of the systems is listed in ascending order: Modified Merle d'Aubigne and Postel Score (MDA), Lower Extremity Functional Scale (LEFS), Western Ontario and McMaster Universities Hip Outcome Assessment (WOMAC), Harris Hip Score (HHS), Larson Score, Hip Disability and Osteoarthritis Outcome Score (HOOS), and Short-form 36 (SF-36). The WOMAC and Larson Score coefficients of variation were the largest, and the HOOS and MDA were the smallest. There was a significantly higher mean time to completion in those who were above or equal to the age of 55 years as compared to those who were below the age of 55 (227 vs. 166 seconds

  5. Negative Consequences of Poor Driving Outcomes Reported by Adolescents With and Without ADHD.

    PubMed

    Narad, Megan E; Garner, Annie A; Antonini, Tanya N; Kingery, Kathleen M; Tamm, Leanne; Calhoun, Heather R; Epstein, Jeffery N

    2015-03-16

    Although adolescents with ADHD report less driving experience, a greater proportion of adolescents with ADHD report receiving at least one ticket; however, no study has examined the severity of infractions committed by adolescent drivers with ADHD. A total of 61 adolescents (28 ADHD, 33 controls) aged 16 to 17 with a valid driver's license completed a self-report Driving History Questionnaire (DHQ), which asked about months of driving experience, negative driving outcomes, and severity of consequences. A greater proportion of adolescents with ADHD reported receiving fines, points on their driver's license, and remedial driving class. Furthermore, adolescents with ADHD reported attending a greater number of hours in remedial driving class, and a greater expense associated with fines. Importantly, ADHD-related negative driving outcomes manifest early in driving careers. Furthermore, increased negative consequences of poor and/or risky driving among adolescents with ADHD were evident despite having fewer months of independent driving. © 2015 SAGE Publications.

  6. Primary outcomes reporting in trials of paediatric type 1 diabetes mellitus: a systematic review.

    PubMed

    Khanpour Ardestani, Samaneh; Karkhaneh, Mohammad; Yu, Hai Chuan; Hydrie, Muhammad Zafar Iqbal; Vohra, Sunita

    2017-12-19

    Our objective was to systematically review randomised clinical trials (RCTs) of paediatric type 1 diabetes mellitus (T1DM) to assess reporting of (1) primary outcome, (2) outcome measurement properties and (3) presence or absence of adverse events. Electronic searches in MEDLINE, EMBASE, CINAHL, Cochrane SR and the Cochrane Central Register of Controlled Trials (CENTRAL) databases were undertaken. The search period was between 2001 and 2017. English-language RCTs on children younger than 21 years with T1DM were selected. We excluded studies of diagnostic or screening tools, multiple phase studies, protocols, and follow-up or secondary analysis of data. Of 11 816 unique references, 231 T1DM RCTs were included. Of total 231 included studies, 117 (50.6%) trials failed to report what their primary outcome was. Of 114 (49.4%) studies that reported primary outcome, 88 (77.2%) reported one and 26 (22.8%) more than one primary outcomes. Of 114 studies that clearly stated their primary outcome, 101 (88.6%) used biological/physiological measurements and 13 (11.4%) used instruments (eg, questionnaires, scales, etc) to measure their primary outcome; of these, 12 (92.3%) provided measurement properties or related citation. Of the 231 included studies, 105 (45.5%) reported that adverse events occurred, 39 (16.9%) reported that no adverse events were identified and 87 (37.7%) did not report on the presence or absence of adverse events. Despite tremendous efforts to improve reporting of clinical trials, clear reporting of primary outcomes of RCTs for paediatric T1DM is still lacking. Adverse events due to DM interventions were often not reported in the included trials. Transparent reporting of primary outcome, validity of measurement tools and adverse events need to be improved in paediatric T1DM trials. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise

  7. Patient-reported outcomes in child and adolescent mental health services (CAMHS): use of idiographic and standardized measures.

    PubMed

    Wolpert, Miranda; Ford, Tamsin; Trustam, Emma; Law, Duncan; Deighton, Jessica; Flannery, Halina; Fugard, Andrew J B; Fugard, Rew J B

    2012-04-01

    There is increasing emphasis on use of patient-reported outcome measures (PROMs) in mental health but little research on the best approach, especially where there are multiple perspectives. To present emerging findings from both standardized and idiographic child-, parent- and clinician-rated outcomes in child and adolescent mental health services (CAMHS) and consider their correlations. Outcomes were collected in CAMHS across the UK. These comprised idiographic measures (goal-based outcomes) and standardized measures (practitioner-rated Children's Global Assessment Scale; child- and parent-rated Strengths and Difficulties Questionnaire). There was reliable positive change from the beginning of treatment to later follow-up according to all informants. Standardized clinician function report was correlated with standardized child difficulty report (r  =  - 0.26), standardized parent report (r  =  - 0.28) and idiographic joint client-determined goals (r  =  0.38) in the expected directions. These results suggest that routine outcome monitoring is feasible, and suggest the possibility of using jointly agreed idiographic measures alongside particular perspectives on outcome as part of a PROMs approach.

  8. Patient-reported allergies predict postoperative outcomes and psychosomatic markers following spine surgery.

    PubMed

    Xiong, David D; Ye, Wenda; Xiao, Roy; Miller, Jacob A; Mroz, Thomas E; Steinmetz, Michael P; Nagel, Sean J; Machado, Andre G

    2018-05-22

    Prior studies have shown that patient-reported allergies can be prognostic of poorer postoperative outcomes. To investigate the correlation between self-reported allergies and outcomes after cervical or lumbar spine surgery. Retrospective cohort study at a single tertiary-care institution. All patients undergoing cervical or lumbar spine surgery from 2009-2014. The primary outcome measure was change in the EuroQol-5 Dimensions (EQ-5D) following surgery. Secondary outcomes included change in the Pain Disability Questionnaire (PDQ) and Patient Health Questionnaire-9 (PHQ-9), achieving the minimal clinically important difference (MCID) in these measures, as well as cost of admission. Prior to and following surgery, EQ-5D, PDQ, and PHQ-9 were recorded for patients with available data. Paired student's t-tests were used to compare change in these measures following surgery. Multivariable linear and logistic regression were used to assess the relationship between the log transformation of the total number of allergies and outcomes. 592 cervical patients and 4,465 lumbar patients were included. The median number of reported allergies was two. The EQ-5D index increased from 0.539 to 0.703 for cervical patients and from 0.530 to 0.676 for lumbar patients (p<0.01 for both). Patients experienced significant pain improvement by the PDQ (80.1 to 58.2 for cervical patients, 79.4 to 58.1 for lumbar patients; p<0.01). Using multivariable logistic regression, the log transformation of number of allergies predicted significantly higher odds of achieving the PDQ MCID (OR = 2.09, 95% CI 1.05-4.15, p=0.02 for cervical patients; OR = 1.30, 95% CI 1.03-1.68, p=0.03 for lumbar patients). However, this relationship was not durable for patients with follow-up exceeding 1 year. The log transformation of number of allergies for lumbar patients predicted significantly increased cost of admission (β=$3,597, p<0.01) and trended towards significance among cervical patients (β=$1,842, p=0

  9. Measuring outcome from vestibular rehabilitation, part II: refinement and validation of a new self-report measure.

    PubMed

    Morris, Anna E; Lutman, Mark E; Yardley, Lucy

    2009-01-01

    A prototype self-report measure of vestibular rehabilitation outcome is described in a previous paper. The objectives of the present work were to identify the most useful items and assess their psychometric properties. Stage 1: One hundred fifty-five participants completed a prototype 36-item Vestibular Rehabilitation Benefit Questionnaire (VRBQ). Statistical analysis demonstrated its subscale structure and identified redundant items. Stage 2: One hundred twenty-four participants completed a refined 22-item VRBQ and three established questionnaires (Dizziness Handicap Inventory, DHI; Vertigo Symptom Scale short form, VSS-sf; Medical Outcomes Study short form 36, SF-36) in a longitudinal study. Statistical analysis revealed four internally consistent subscales of the VRBQ: Dizziness, Anxiety, Motion-Provoked Dizziness, and Quality of Life. Correlations with the DHI, VSS-sf, and SF-36 support the validity of the VRBQ, and effect size estimates suggest that the VRBQ is more responsive than comparable questionnaires. Twenty participants completed the VRBQ twice in a 24-hour period, indicating excellent test-retest reliability. The VRBQ appears to be a concise and psychometrically robust questionnaire that addresses the main aspects of dizziness impact.

  10. Use of the Liverpool Elbow Score as a postal questionnaire for the assessment of outcome after total elbow arthroplasty.

    PubMed

    Ashmore, Alexander M; Gozzard, Charles; Blewitt, Neil

    2007-01-01

    The Liverpool Elbow Score (LES) is a newly developed, validated elbow-specific score. It consists of a patient-answered questionnaire (PAQ) and a clinical assessment. The purpose of this study was to determine whether the PAQ portion of the LES could be used independently as a postal questionnaire for the assessment of outcome after total elbow arthroplasty and to correlate the LES and the Mayo Elbow Performance Score (MEPS). A series of 51 total elbow replacements were reviewed by postal questionnaire. Patients then attended the clinic for assessment by use of both the LES and the MEPS. There was an excellent response rate to the postal questionnaire (98%), and 44 elbows were available for clinical review. Good correlation was shown between the LES and the MEPS (Spearman correlation coefficient, 0.84; P < .001) and between the PAQ portion of the LES and the MEPS (Spearman correlation coefficient, 0.76; P < .001). We conclude that there is good correlation between the LES PAQ component and the MEPS, suggesting that outcome assessment is possible by postal questionnaire.

  11. Detecting Endometriosis in Adolescents: Why Not Start from Self-Report Screening Questionnaires for Adult Women?

    PubMed

    Geysenbergh, Brecht; Dancet, Eline A F; D'Hooghe, Thomas

    2017-01-01

    Endometriosis in adolescent girls is often diagnosed after a long delay. This diagnostic delay can be associated with more advanced stages of endometriosis and with a higher likelihood of fertility problems at a later age. A systematic review of literature and quality assessment was performed in order to identify questionnaires that were developed to identify adult women with endometriosis. Based on these questionnaires, specific questions that had been reported to be predictive for endometriosis were selected and included in a newly composed questionnaire with the aim to identify adolescents at risk of developing endometriosis. Based on the literature, we identified 5 questionnaires developed to identify adult women with endometriosis; this questionnaire contained 6 questions that had been reported to be predictive for adult endometriosis. These questions query age of menarche, cycle duration, dysmenorrhea, pain descriptors, dyschezia and urinary symptoms and were combined into a new self-report questionnaire aimed to identify adolescents at risk to develop endometriosis. We developed a self-report questionnaire aimed to identify adolescents at risk to develop endometriosis based on questions from self-report questionnaires that have been reported to identify adult women with endometriosis. © 2016 S. Karger AG, Basel.

  12. Migrants and obstetrics in Austria--applying a new questionnaire shows differences in obstetric care and outcome.

    PubMed

    Oberaigner, Willi; Leitner, Hermann; Oberaigner, Karin; Marth, Christian; Pinzger, Gerald; Concin, Hans; Steiner, Horst; Hofmann, Hannes; Wagner, Teresa; Mörtl, Manfred; Ramoni, Angela

    2013-01-01

    Immigration plays a major role in obstetrics in Austria, and about 18 % of the Austrian population are immigrants. Therefore, we aimed to (1) test the feasibility of a proposed questionnaire for assessment of migrant status in epidemiological research and (2) assess some important associations between procedures and outcomes in obstetrics and migration in selected departments in Austria. We adapted a standardized questionnaire to the main immigration groups in Austria. Information on country of origin, length of residence in Austria and German-language ability was collected from eight selected obstetrics departments. Of the 1,971 questionnaires, 1,873 questionnaires of singleton births were selected and included in the analysis. We analyzed a total of 1,873 parturients with singleton births, of which 35 % had migrant status, 12 % were from ex-Yugoslavia, 12 % were from Turkey, and 12 % were from other countries. The proportion of parturients having their first care visit after the 12th week of pregnancy was higher in migrant groups (19 %). Smoking was highest in the migrants from ex-Yugoslavia (21 %). Vaginal delivery was more frequent in migrants from ex-Yugoslavia (78 %) and Turkey (83 %) than in nonmigrants (71 %) and episiotomy was more frequently performed in migrants from other countries. All differences are statistically significant. Administration of a standardized questionnaire for assessment of migrant status in obstetric departments in Austria was shown to be feasible. We assessed differences in obstetric care and outcome and consequently recommend that action should be initiated in Austria toward harmonizing obstetric procedures among the migrant and the nonmigrant groups and toward minimizing risk factors.

  13. Validation study of an electronic method of condensed outcomes tools reporting in orthopaedics.

    PubMed

    Farr, Jack; Verma, Nikhil; Cole, Brian J

    2013-12-01

    Patient-reported outcomes (PRO) instruments are a vital source of data for evaluating the efficacy of medical treatments. Historically, outcomes instruments have been designed, validated, and implemented as paper-based questionnaires. The collection of paper-based outcomes information may result in patients becoming fatigued as they respond to redundant questions. This problem is exacerbated when multiple PRO measures are provided to a single patient. In addition, the management and analysis of data collected in paper format involves labor-intensive processes to score and render the data analyzable. Computer-based outcomes systems have the potential to mitigate these problems by reformatting multiple outcomes tools into a single, user-friendly tool.The study aimed to determine whether the electronic outcomes system presented produces results comparable with the test-retest correlations reported for the corresponding orthopedic paper-based outcomes instruments.The study is designed as a crossover study based on consecutive orthopaedic patients arriving at one of two designated orthopedic knee clinics.Patients were assigned to complete either a paper or a computer-administered questionnaire based on a similar set of questions (Knee injury and Osteoarthritis Outcome Score, International Knee Documentation Committee form, 36-Item Short Form survey, version 1, Lysholm Knee Scoring Scale). Each patient completed the same surveys using the other instrument, so that all patients had completed both paper and electronic versions. Correlations between the results from the two modes were studied and compared with test-retest data from the original validation studies.The original validation studies established test-retest reliability by computing correlation coefficients for two administrations of the paper instrument. Those correlation coefficients were all in the range of 0.7 to 0.9, which was deemed satisfactory. The present study computed correlation coefficients between

  14. Physiotherapy Questionnaires App to Deliver Main Musculoskeletal Assessment Questionnaires: Development and Validation Study

    PubMed Central

    Teixeira Neto, Nestor Cavalcante; Lima, Yuri Lopes; Almeida, Gabriel Peixoto Leão; Bezerra, Márcio Almeida; Lima, Pedro Olavo De Paula

    2018-01-01

    Background Patient-reported outcomes (PROs) translate subjective outcomes into objective data that can be quantified and analyzed. Nevertheless, the use of PROs in their traditional paper format is not practical for clinical practice due to limitations associated with the analysis and management of the data. To address the need for a viable way to group and utilize the main functioning assessment tools in the field of musculoskeletal disorders, the Physiotherapy Questionnaires app was developed. Objective This study aims to explain the development of the app, to validate it using two questionnaires, and to analyze whether participants prefer to use the app or the paper version of the questionnaires. Methods In the first stage, the app for an Android operational system was developed. In the second stage, the aim was to select questionnaires that were most often used in musculoskeletal clinical practice and research. The Foot and Ankle Outcome Score (FAOS) and American Orthopaedic Foot and Ankle Society (AOFAS) questionnaire were selected to validate the app. In total, 50 participants completed the paper and app versions of the AOFAS and 50 completed the FAOS. The study’s outcomes were the correlation of the data between the paper and app versions as well as the preference of the participants between the two versions. Results The app was approved by experts after the adaptations of the layout for mobile phones and a total of 18 questionnaires were included in the app. Moreover, the app allows the generation of PDF and Excel files with the patients’ data. In regards to validity, the mean of the total scores of the FAOS were 91.54% (SD 8.86%) for the paper version and 91.74% (SD 9.20%) for the app. There was no statistically significant differences in the means of the total scores or the subscales (P=.11-.94). The mean total scores for the AOFAS were 93.94 (SD 8.47) for the paper version and 93.96 (SD 8.48) for the app. No statistically significant differences were

  15. European multicentre pilot survey to assess vitamin D status in rheumatoid arthritis patients and early development of a new Patient Reported Outcome questionnaire (D-PRO).

    PubMed

    Vojinovic, Jelena; Tincani, Angela; Sulli, Alberto; Soldano, Stefano; Andreoli, Laura; Dall'Ara, Francesca; Ionescu, Ruxandra; Pasalic, Katarina Simic; Balcune, Inete; Ferraz-Amaro, Ivan; Tlustochowicz, Małgorzata; Butrimiene, Irena; Punceviciene, Egle; Toroptsova, Natalia; Grazio, Simeon; Morovic-Vergles, Jadranka; Masaryk, Pavol; Otsa, Kati; Bernardes, Miguel; Boyadzhieva, Vladimira; Salaffi, Fausto; Cutolo, Maurizio

    2017-05-01

    To collect data on vitamin D (25(OH)D) serum levels in a large number of rheumatoid arthritis (RA) patients from different European countries, to investigate their relation with disease activity, disability, quality of life, and possibly to construct a new Patient Reported Outcome (PRO) questionnaire in order to self-estimate if they are at risk for vitamin D insufficiency/deficiency-related clinical implications (D-PRO). This was a European League Against Rheumatism (EULAR) supported cross-sectional study (project No CLI064) which involved 625 RA patients (mean age 55±11years, mean disease duration 11±9years), 276 age and sex matched healthy subjects, and rheumatologists working in academic institutions or hospital centres, as well as PARE organizations (patient representatives) from 13 European countries. Serum samples for 25(OH)D level measurement were collected during winter time and analyzed in a central laboratory using chemiluminescence immunoassay (DiaSorin). Patient past medical history was recorded. RA patients were provided with three questionnaires: the Rheumatoid Arthritis Impact Diseases score (RAID), the Health Assessment Questionnaire (HAQ), and the new D-PRO questionnaire at the time of 25(OH)D serum sampling. D-PRO questionnaire consisted of three domains, Symptom Risk Score (SRS), Habitus Risk Score (HRS) and Global Risk Score (SRS+HRS=GRS), constructed with items possibly related to vitamin D deficiency. D-PRO was correlated with both clinical and PRO scores. DAS28-CRP was also evaluated. Statistical analysis was performed by non parametric tests. Mean serum concentration of 25(OH)D in RA patients (17.62±9.76ng/ml) was found significantly lower if compared to the levels obtained in matched controls (18.95±9.45ng/ml) (p=0.01), with statistically significant differences among several European countries. Negative correlations were found between 25(OH)D serum levels and DAS28-CRP (p<0.001), RAID (p=0.05) and HAQ (p=0.04) scores in the RA

  16. Patient-reported outcomes of 182 adults with severe haemophilia in Germany comparing prophylactic vs. on-demand replacement therapy.

    PubMed

    Mondorf, W; Kalnins, W; Klamroth, R

    2013-07-01

    Clotting factor replacement therapy has a major impact on the quality of life in patients with haemophilia. To analyse and compare the outcomes of on-demand and prophylactic treatment regimens in child- and adulthood, a self-evaluation questionnaire was sent to 182 patients over 30 years of age with severe haemophilia A or B. Analysis of the questionnaire results revealed that most study participants had been treated on-demand in childhood, but that the majority of these patients subsequently switched to prophylaxis. However, of those patients who began with prophylaxis as children, the vast majority maintained prophylactic treatment as adults. Inhibitor development was reported significantly more frequently by patients who started with on-demand treatment than by those who started with prophylaxis. In the year prior to completing the questionnaire, adults with severe haemophilia who received prophylactic treatment reported a significantly lower incidence of bleeding as a result of more frequent factor consumption. These results are in close accordance with published prospective data. Although nearly all patients with severe haemophilia had joint pain due to bleeding, those who had always had prophylactic treatment reported superior outcomes in terms of the need for joint replacement, walking speed and distance, participation in school sports and further education. These data clearly underline the superiority of prophylactic treatment for the majority of individuals with severe haemophilia. The worst outcomes were found in those treated on-demand in childhood who later switched to prophylaxis. In contrast to most studies which have compared treatment regimens on the basis of data from healthcare professionals, this study reflects treatment outcomes from the patient's perspective. © 2013 John Wiley & Sons Ltd.

  17. Comparative effectiveness studies examining patient-reported outcomes among children with cleft lip and/or palate: a systematic review.

    PubMed

    Ranganathan, Kavitha; Vercler, Christian J; Warschausky, Seth A; MacEachern, Mark P; Buchman, Steven R; Waljee, Jennifer F

    2015-01-01

    Health care policy makers are increasingly encouraging comparative effectiveness research. Little is known regarding comparative studies among children with cleft lip and/or palate. Cleft lip and/or palate profoundly influences self-perception and social functioning, and patient-reported outcomes provide a unique perspective on the success of reconstruction. The purpose of this study was to systematically review the literature regarding patient-reported outcomes among patients with cleft lip and/or palate. The authors reviewed articles from MEDLINE, Embase, and PsycInfo that examined the use of patient-reported outcome instruments for cleft lip and/or palate. Studies of patients with cleft lip and/or palate across any age that described the use of patient-completed measures in patient and control populations were included. A research librarian confirmed the search, and two independent, blinded reviewers performed full-text review. The authors identified 1979 articles and selected 30 for inclusion. Forty-two different assessment tools were used to analyze factors such as self-esteem, behavior, and social support. The Strengths and Difficulties Questionnaire was most commonly used (n = 7), followed by the Childhood Experience Questionnaire (n = 5), and the Satisfaction with Appearance survey (n = 4). Barriers to analysis included lack of standardization of survey administration, effect of publication bias, and variations in patient populations between individual studies. Comparative studies of patient-reported outcomes among patients with cleft lip and/or palate are infrequent. Many instruments exist to measure patient-reported outcomes in this population, but no specific standard exists. Identifying efficient and targeted forms of instrument selection and administration will enhance comparative studies among children with cleft lip and/or palate. Diagnostic, III.

  18. Swallowing difficulties with medication intake assessed with a novel self-report questionnaire in patients with systemic sclerosis – a cross-sectional population study

    PubMed Central

    Messerli, Markus; Aschwanden, Rebecca; Buslau, Michael; Hersberger, Kurt E; Arnet, Isabelle

    2017-01-01

    Objectives To assess subjective swallowing difficulties (SD) with medication intake and their practical consequences in patients suffering from systemic sclerosis (SSc) with a novel self-report questionnaire. Design and setting Based on a systematic literature review, we developed a self-report questionnaire and got it approved by an expert panel. Subsequently, we sent the questionnaire by post mail to SSc patients of the European Center for the Rehabilitation of Scleroderma Rheinfelden, Switzerland. Participants Patients were eligible if they were diagnosed with SSc, treated at the center, and were of age ≥18 years at the study start. Main outcome measures Prevalence and pattern of SD with oral medication intake, including localization and intensity of complaints. Results The questionnaire consisted of 30 items divided into five sections Complaints, Intensity, Localization, Coping strategies, and Adherence. Of the 64 SSc patients eligible in 2014, 43 (67%) returned the questionnaire. Twenty patients reported SD with medication intake (prevalence 47%), either currently (11; 26%) or in the past that had been overcome (9; 21%). Self-reported SD were localized mostly in the larynx (43%) and esophagus (34%). They were of moderate (45%) or strong to unbearable intensity (25%). Modification of the dosage form was reported in 40% of cases with SD. Adherence was poor for 20 (47%) patients and was not associated with SD (p=0.148). Conclusion Our novel self-report questionnaire is able to assess the pattern of complaints linked to medication intake, that is, localization and intensity. It may serve as a guide for health care professionals in selecting the most suitable therapy option, enabling tailored counseling to reduce inappropriate medication modifications. PMID:29033556

  19. Measuring quality of life in cleft lip and palate patients: currently available patient-reported outcomes measures.

    PubMed

    Eckstein, Donna A; Wu, Rebecca L; Akinbiyi, Takintope; Silver, Lester; Taub, Peter J

    2011-11-01

    Patient-reported outcomes in cleft lip and palate treatment are critical for patient care. Traditional surgical outcomes focused on objective measures, such as photographs, anatomic measurements, morbidity, and mortality. Although these remain important, they leave many questions unanswered. Surveys that include aesthetics, speech, functionality, self-image, and quality of life provide more thorough outcomes assessment. It is vital that reliable, valid, and comprehensive questionnaires are available to craniofacial surgeons. The authors performed a literature review to identify questionnaires validated in cleft lip and palate patients. Qualifying instruments were assessed for adherence to guidelines for development and validation by the scientific advisory committee and for content. The authors identified 44 measures used in cleft lip and palate studies. After 15 ad hoc questionnaires, eight generic instruments, 11 psychiatric instruments, and one non-English language questionnaire were excluded, nine measures remained. Of these, four were never validated in the cleft population. Analysis revealed one craniofacial-specific measure (Youth Quality of Life-Facial Differences), two voice-related measures (Patient Voice-Related Quality of Life and Cleft Audit Protocol for Speech-Augmented), and two oral health-related measures (Child Oral Health Impact Profile and Child Oral Health Quality of Life). The Youth Quality of Life-Facial Differences, Child Oral Health Impact Profile, and Child Oral Health Quality of Life questionnaires were sufficiently validated. None was created specifically for clefts, resulting in content limitations. There is a lack of comprehensive, valid, and reliable questionnaires for cleft lip and palate surgery. For thorough assessment of satisfaction, further research to develop and validate cleft lip and palate surgery-specific instruments is needed.

  20. Convergent validity of a brief self-reported physical activity questionnaire.

    PubMed

    Gabriel, Kelley Pettee; Sidney, Stephen; Jacobs, David R; Quesenberry, Charles P; Reis, Jared P; Jiang, Sheng-Fang; Sternfeld, Barbara

    2014-08-01

    The objective of this study is to determine whether summary estimates of a self-report physical activity questionnaire that does not specifically assess frequency or duration (the Coronary Artery Risk Development in Young Adults (CARDIA) physical activity history (PAH)) differs from the summary estimates of one that does (CARDIA Supplemental Questionnaire). After the year 25 examination (2010-2011), 203 CARDIA black and white men and women (age 50.3 ± 3.6 yr) at the Oakland, CA, site participated in this comparison study. The between-questionnaire association and agreement were determined for continuous and categorical estimates on the basis of 1) quartiles and 2) meeting 2008 physical activity guidelines. Differences in participant characteristics by concordance/discordance status were also examined. Finally, receiver operating characteristic curves were computed to determine the accuracy of the PAH compared with the supplemental questionnaire. Reported physical activity levels were high and varied significantly by race and sex (all P < 0.01). Between-questionnaire estimates were significantly correlated (rho = 0.75 to 0.90, all P < 0.001) and had high agreement (κ = 0.51 to 0.80) across all race/sex groups. A higher proportion of women than men were classified as concordant by quartile of vigorous intensity (P = 0.001), but no other participant characteristics were associated with concordant/discordant quartile ranking. Participants classified as concordant on the basis of physical activity guidelines had lower body mass index than those classified as discordant (both P < 0.05). The area under the curve was 0.95, suggesting that the PAH has high accuracy for classifying individuals as meeting physical activity guidelines. Although it is inconvenient that the PAH is not expressed in more standard units, these findings support the practice of not directly assessing frequency and duration, which are frequent sources of reporting error.

  1. Patient-reported questionnaires in MS rehabilitation: responsiveness and minimal important difference of the multiple sclerosis questionnaire for physiotherapists (MSQPT).

    PubMed

    van der Maas, Nico Arie

    2017-03-16

    The Multiple Sclerosis Questionnaire for Physical Therapists (MSQPT) is a patient-rated outcome questionnaire for evaluating the rehabilitation of persons with multiple sclerosis (MS). Responsiveness was evaluated, and minimal important difference (MID) estimates were calculated to provide thresholds for clinical change for four items, three sections and the total score of the MSQPT. This multicentre study used a combined distribution- and anchor-based approach with multiple anchors and multiple rating of change questions. Responsiveness was evaluated using effect size, standardized response mean (SRM), modified SRM and relative efficiency. For distribution-based MID estimates, 0.2 and 0.33 standard deviations (SD), standard error of measurement (SEM) and minimal detectable change were used . Triangulation of anchor- and distribution-based MID estimates provided a range of MID values for each of the four items, the three sections and the total score of the MSQPT. The MID values were tested for their sensitivity and specificity for amelioration and deterioration for each of the four items, the three sections and the total score of the MSQPT. The MID values of each item and section and of the total score with the best sensitivity and specificity were selected as thresholds for clinical change. The outcome measures were the MSQPT, Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS), rating of change questionnaires, Expanded Disability Status Scale, 6-metre timed walking test, Berg Balance Scale and 6-minute walking test. The effect size ranged from 0.46 to 1.49. The SRM data showed comparable results. The modified SRM ranged from 0.00 to 0.60. Anchor-based MID estimates were very low and were comparable with SD- and SEM-based estimates. The MSQPT was more responsive than the HAQUAMS in detecting improvement but less responsive in finding deterioration. The best MID estimates of the items, sections and total score, expressed in percentage of their

  2. Predicting functional outcomes among college drinkers: reliability and predictive validity of the Young Adult Alcohol Consequences Questionnaire.

    PubMed

    Read, Jennifer P; Merrill, Jennifer E; Kahler, Christopher W; Strong, David R

    2007-11-01

    Heavy drinking and associated consequences are widespread among U.S. college students. Recently, Read et al. (Read, J. P., Kahler, C. W., Strong, D., & Colder, C. R. (2006). Development and preliminary validation of the Young Adult Alcohol Consequences Questionnaire. Journal of Studies on Alcohol, 67, 169-178) developed the Young Adult Alcohol Consequences Questionnaire (YAACQ) to assess the broad range of consequences that may result from heavy drinking in the college milieu. In the present study, we sought to add to the psychometric validation of this measure by employing a prospective design to examine the test-retest reliability, concurrent validity, and predictive validity of the YAACQ. We also sought to examine the utility of the YAACQ administered early in the semester in the prediction of functional outcomes later in the semester, including the persistence of heavy drinking, and academic functioning. Ninety-two college students (48 females) completed a self-report assessment battery during the first weeks of the Fall semester, and approximately one week later. Additionally, 64 subjects (37 females) participated at an optional third time point at the end of the semester. Overall, the YAACQ demonstrated strong internal consistency, test-retest reliability, and concurrent and predictive validity. YAACQ scores also were predictive of both drinking frequency, and "binge" drinking frequency. YAACQ total scores at baseline were an early indicator of academic performance later in the semester, with greater number of total consequences experienced being negatively associated with end-of-semester grade point average. Specific YAACQ subscale scores (Impaired Control, Dependence Symptoms, Blackout Drinking) showed unique prediction of persistent drinking and academic outcomes.

  3. Patient-reported outcomes in insomnia: development of a conceptual framework and endpoint model.

    PubMed

    Kleinman, Leah; Buysse, Daniel J; Harding, Gale; Lichstein, Kenneth; Kalsekar, Anupama; Roth, Thomas

    2013-01-01

    This article describes qualitative research conducted with patients with clinical diagnoses of insomnia and focuses on the development of a conceptual framework and endpoint model that identifies a hierarchy and interrelationships of potential outcomes in insomnia research. Focus groups were convened to discuss how patients experience insomnia and to generate items for patient-reported questionnaires on insomnia and associated daytime consequences. Results for the focus group produced two conceptual frameworks: one for sleep and one for daytime impairment. Each conceptual framework consists of hypothesized domains and items in each domain based on patient language taken from the focus group. These item pools may ultimately serve as a basis to develop new questionnaires to assess insomnia.

  4. Assessment of Patient-Reported Outcome Instruments to Assess Chronic Low Back Pain.

    PubMed

    Ramasamy, Abhilasha; Martin, Mona L; Blum, Steven I; Liedgens, Hiltrud; Argoff, Charles; Freynhagen, Rainer; Wallace, Mark; McCarrier, Kelly P; Bushnell, Donald M; Hatley, Noël V; Patrick, Donald L

    2017-06-01

     To identify patient-reported outcome (PRO) instruments that assess chronic low back pain (cLBP) symptoms (specifically pain qualities) and/or impacts for potential use in cLBP clinical trials to demonstrate treatment benefit and support labeling claims.  Literature review of existing PRO measures.  Publications detailing existing PRO measures for cLBP were identified, reviewed, and summarized. As recommended by the US Food & Drug Administration (FDA) PRO development guidance, standard measurement characteristics were reviewed, including development history, psychometric properties (validity and reliability), ability to detect change, and interpretation of observed changes.  Thirteen instruments were selected and reviewed: Low Back Pain Bothersomeness Scale, Neuropathic Pain Symptom Inventory, PainDETECT, Pain Quality Assessment Scale Revised, Revised Short Form McGill Pain Questionnaire, Low Back Pain Impact Questionnaire, Oswestry Disability Index, Pain Disability Index, Roland-Morris Disability Questionnaire, Brief Pain Inventory and Brief Pain Inventory Short Form, Musculoskeletal Outcomes Data Evaluation and Management System Spine Module, Orebro Musculoskeletal Pain Questionnaire, and the West Haven-Yale Multidimensional Pain Inventory Interference Scale. The instruments varied in the aspects of pain and/or impacts that they assessed, and none of the instruments fulfilled all criteria for use in clinical trials to support labeling claims based on recommendations outlined in the FDA PRO guidance.  There is an unmet need for a validated PRO instrument to evaluate cLBP-related symptoms and impacts for use in clinical trials. © 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  5. Measurement Properties of the Brief Michigan Hand Outcomes Questionnaire in Patients With Dupuytren Contracture.

    PubMed

    Wehrli, Martina; Hensler, Stefanie; Schindele, Stephan; Herren, Daniel B; Marks, Miriam

    2016-09-01

    The brief Michigan Hand Outcomes Questionnaire (briefMHQ) was developed as a shorter version of the Michigan Hand Outcomes Questionnaire (MHQ), but its measurement properties have not been investigated in patients with Dupuytren contracture. The objective of the study was to investigate the reliability, validity, responsiveness, and interpretability of the briefMHQ. Fifty-seven patients diagnosed with Dupuytren contracture completed the briefMHQ as well as the full-length MHQ and Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire at baseline. Two to 14 days after baseline and 1 year after collagenase injection or surgery, patients again filled out the briefMHQ. Reliability was determined using the intraclass correlation coefficient and by calculating internal consistency (Cronbach alpha). Validity was tested by quantifying correlations with the full-length MHQ and QuickDASH. Responsiveness, based on the standardized response mean and the minimally clinically important change, was also determined. The briefMHQ had an intraclass correlation coefficient of 0.87, Cronbach alpha of 0.88, and correlations of r = 0.88 and -0.82 with the original MHQ and QuickDASH, respectively. The standardized response mean was 0.9 and the minimally clinically important change was 7 points. Overall, the briefMHQ demonstrates excellent reliability, good validity, and high responsiveness in patients with Dupuytren contracture. The briefMHQ is an accurate and time-saving tool to evaluate patients with Dupuytren contracture and the effect of a corresponding treatment. Copyright © 2016 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

  6. Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs)

    PubMed Central

    Weldring, Theresa; Smith, Sheree M.S.

    2013-01-01

    In recent years, there has been an increased focus on placing patients at the center of health care research and evaluating clinical care in order to improve their experience and ensure that research is both robust and of maximum value for the use of medicinal products, therapy, or health services. This paper provides an overview of patients’ involvement in clinical research and service evaluation along with its benefits and limitations. We describe and discuss patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs), including the trends in current research. Both the patient-reported experiences measures (PREMs) and patient and public involvement (PPI) initiative for including patients in the research processes are also outlined. PROs provide reports from patients about their own health, quality of life, or functional status associated with the health care or treatment they have received. PROMs are tools and/or instruments used to report PROs. Patient report experiences through the use of PREMs, such as satisfaction scales, providing insight into the patients’ experience with their care or a health service. There is increasing international attention regarding the use of PREMS as a quality indicator of patient care and safety. This reflects the ongoing health service commitment of involving patients and the public within the wider context of the development and evaluation of health care service delivery and quality improvement. PMID:25114561

  7. Self-reported exercise and longitudinal outcomes in cystic fibrosis: a retrospective cohort study.

    PubMed

    Collaco, Joseph M; Blackman, Scott M; Raraigh, Karen S; Morrow, Christopher B; Cutting, Garry R; Paranjape, Shruti M

    2014-10-06

    Cystic fibrosis (CF) is characterized by recurrent respiratory infections and progressive lung disease. Whereas exercise may contribute to preserving lung function, its benefit is difficult to ascertain given the selection bias of healthier patients being more predisposed to exercise. Our objective was to examine the role of self-reported exercise with longitudinal lung function and body mass index (BMI) measures in CF. A total of 1038 subjects with CF were recruited through the U.S. CF Twin-Sibling Study. Questionnaires were used to determine exercise habits. Questionnaires, chart review, and U.S. CF Foundation Patient Registry data were used to track outcomes. Within the study sample 75% of subjects self-reported regular exercise. Exercise was associated with an older age of diagnosis (p = 0.002), older age at the time of ascertainment (p < 0.001), and higher baseline FEV1 (p = 0.001), but not CFTR genotype (p = 0.64) or exocrine pancreatic function (p = 0.19). In adjusted mixed models, exercise was associated with both a reduced decline in FEV1 (p < 0.001) and BMI Z-score (p = 0.001) for adults, but not children aged 10-17 years old. In our retrospective study, self-reported exercise was associated with improved longitudinal nutritional and pulmonary outcomes in cystic fibrosis for adults. Although prospective studies are needed to confirm these associations, programs to promote regular exercise among individuals with cystic fibrosis would be beneficial.

  8. Usefulness of self-report questionnaires for psychological assessment of patients with tinnitus and hyperacusis and patients' views of the questionnaires.

    PubMed

    Aazh, Hashir; Moore, Brian C J

    2017-07-01

    The objective was to determine the relevance and applicability of psychological questionnaires to patients seeking help for tinnitus and/or hyperacusis. This was a questionnaire-based survey. The following questionnaires were administered: Generalised Anxiety Disorder (GAD-7), Short Health Anxiety Inventory (SHAI), Mini-Social Phobia Inventory (Mini-SPIN), Obsessive Compulsive Inventory-Revised (OCI-R), Panic Disorder Severity Scale-Self Report (PDSS-SR), Patient Health Questionnaire (PHQ-9) and Penn State Worry Questionnaire-Abbreviated version (PSWQ-A). In addition, a patient feedback questionnaire was completed asking about the extent to which each questionnaire was relevant to them and how strongly they would recommend its use in the assessment of patients with tinnitus and hyperacusis. A total of 150/402 consecutive patients seen in a one-year period completed the questionnaires. 65% of patients had abnormal scores for one or more of the questionnaires. All questionnaires except the PDSS-SR were rated as relevant and recommended for use. The GAD-7, SHAI, Mini-SPIN, OCI-R, PSWQ-A and PHQ-9 are recommended for evaluation of psychological problems for patients seeking help for tinnitus and/or hyperacusis. Abnormal results on these questionnaires may indicate the need for referral for possible treatment of psychological problems.

  9. 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…

  10. Outcome-Reporting Bias in Education Research

    ERIC Educational Resources Information Center

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

    2013-01-01

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

  11. Patient-reported outcome measures in reconstructive breast surgery: is there a role for generic measures?

    PubMed

    Korus, Lisa J; Cypel, Tatiana; Zhong, Toni; Wu, Albert W

    2015-03-01

    Patient-reported outcomes provide an invaluable tool in the assessment of outcomes in plastic surgery. Traditionally, patient-reported outcomes have consisted of either generic or ad hoc measures; however, more recently, there has been interest in formally constructed and validated questionnaires that are specifically designed for a particular patient population. The purpose of this systematic review was to determine whether generic measures still have a role in the evaluation of breast reconstruction outcomes, given the recent popularity and push for use of specific measures. A systematic review was performed to identify all articles using patient-reported outcomes in the assessment of postmastectomy breast reconstruction. Frequency of use was tabulated and the most frequently used tools were assessed for success of use, using criteria described previously by the Medical Outcomes Trust. To date, the most frequently used measures are still generic measures. The 36-Item Short-Form Health Survey was the most frequently used and most successfully applied showing evidence of responsiveness in multiple settings. Other measures such as the Hospital Anxiety and Depression Scale, the Hopwood Body Image Scale, and the Rosenberg Self-Esteem Scale were able to show responsiveness in certain settings but lacked evidence as universal tools for the assessment of outcomes in reconstructive breast surgery. Despite the recent advent of measures designed specifically to assess patient-reported outcomes in the breast reconstruction population, there still appears to be a role for the use of generic instruments. Many of these tools would benefit from undergoing formal validation in the breast reconstruction population.

  12. 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

  13. Variations in reporting of outcomes in randomized trials on diet and physical activity in pregnancy: A systematic review.

    PubMed

    Rogozińska, Ewelina; Marlin, Nadine; Yang, Fen; Dodd, Jodie M; Guelfi, Kym; Teede, Helena; Surita, Fernanda; Jensen, Dorte M; Geiker, Nina R W; Astrup, Arne; Yeo, SeonAe; Kinnunen, Tarja I; Stafne, Signe N; Cecatti, Jose G; Bogaerts, Annick; Hauner, Hans; Mol, Ben W; Scudeller, Tânia T; Vinter, Christina A; Renault, Kristina M; Devlieger, Roland; Thangaratinam, Shakila; Khan, Khalid S

    2017-07-01

    Trials on diet and physical activity in pregnancy report on various outcomes. We aimed to assess the variations in outcomes reported and their quality in trials on lifestyle interventions in pregnancy. We searched major databases without language restrictions for randomized controlled trials on diet and physical activity-based interventions in pregnancy up to March 2015. Two independent reviewers undertook study selection and data extraction. We estimated the percentage of papers reporting 'critically important' and 'important' outcomes. We defined the quality of reporting as a proportion using a six-item questionnaire. Regression analysis was used to identify factors affecting this quality. Sixty-six randomized controlled trials were published in 78 papers (66 main, 12 secondary). Gestational diabetes (57.6%, 38/66), preterm birth (48.5%, 32/66) and cesarian section (60.6%, 40/66), were the commonly reported 'critically important' outcomes. Gestational weight gain (84.5%, 56/66) and birth weight (87.9%, 58/66) were reported in most papers, although not considered critically important. The median quality of reporting was 0.60 (interquartile range 0.25, 0.83) for a maximum score of one. Study and journal characteristics did not affect quality. Many studies on lifestyle interventions in pregnancy do not report critically important outcomes, highlighting the need for core outcome set development. © 2017 Japan Society of Obstetrics and Gynecology.

  14. Patient-reported Outcomes in a French Nationwide Survey of Inflammatory Bowel Disease Patients.

    PubMed

    Williet, Nicolas; Sarter, Hélène; Gower-Rousseau, Corinne; Adrianjafy, Charlotte; Olympie, Alain; Buisson, Anne; Beaugerie, Laurent; Peyrin-Biroulet, Laurent

    2017-02-01

    Patient reported-outcomes [PROs] are a major therapeutic goal in inflammatory bowel disease [IBD]. Between January and June 2014, patients affiliated with the French national IBD association filled out six self-questionnaires: quality of life 9QoL, according to the Short Inflammatory Bowel Disease Questionnaire [SIBDQ] and the Short-Form-36 Questionnaire [SF-36] v2); fatigue (the Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F]); work productivity (the Work Productivity and Activity Impairment [WPAI] questionnaire); disability [the I nflammatory Bowel Disease Disability Index]; and anxiety/depression (the Hospital Anxiety and Depression scale [HADS]). Associated factors were identified by univariate and multivariate logistic regression analyses. Datasets were obtained from 1185 IBD patients. Around half of patients reported poor QoL [SIBDQ <45: 53.3%], severe fatigue [FACIT-F <30: 47.4%] and/or depression [HAD-D >7: 49.4%]. One-third of the patients reported anxiety [HAD-A >7: 30.3%] and/or moderate [22.4%] or severe [11.9%] disability. About half of them reported presenteeism and moderate-to-severe loss of work productivity and loss of activity. Poor QoL, severe fatigue, severe disease-related disability, and/or high WPAI were all associated with female gender, unemployment, and disease activity. Poor QoL, severe fatigue, and high WPAI were also associated with the use of tumour necrosis factor antagonists. A history of surgery was associated with poor QoL, whereas age was associated with severe fatigue. Severe depression was associated with female gender and disease activity. The disease burden is very high in IBD, with poor QoL, fatigue, work impairment, and depression in half of patients. Marked disability and anxiety were reported by one-third of patients. Copyright © 2016 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  15. Dental patients' self-reported use of dietary supplements on medical history questionnaires.

    PubMed

    Bakuri, Sarmad; Lanning, Sharon K; Best, Al M; Sabatini, Robert; Gunsolley, John; Waldrop, Thomas C

    2016-01-01

    Dietary supplement effects and drug interactions can lead to significant adverse health events, thus potentially impacting the safe delivery of oral healthcare. This study sought to determine the frequency of, and factors impacting, dietary supplement use among 209 dental patients and whether the design of a medical history questionnaire influences reporting of supplement use. Patients were randomly allocated to 1 of 2 groups in which they completed either a standard medical history questionnaire (n = 107) or the same questionnaire with an additional item about dietary supplement use (n = 102). All patients were then administered a survey with questions about their demographics, their use and knowledge of dietary supplements, and the person or persons who recommended dietary supplement use to the patient. While 62% of the total population (130/209) reported supplement use, specific prompting nearly doubled the number of supplements reported (mean with prompting: 1.53; mean without prompting: 0.76; P < 0.0001). Patients younger than 30 years of age reported significantly less dietary supplement use than all other age groups except the 30-40 age group (P = 0.0003). An estimated 70% of all respondents were not aware of potentially detrimental side effects of dietary supplement use or possible interactions with conventional drug therapies. Since patients tended to report a greater use of dietary supplements when specifically asked about their use on a medical history questionnaire, a checklist or set of designated questions may be a suitable first step toward gathering this essential information.

  16. Worse patient-reported outcome after lateral approach than after anterior and posterolateral approach in primary hip arthroplasty

    PubMed Central

    Havelin, Leif I; Furnes, Ove; Baste, Valborg; Nordsletten, Lars; Hovik, Oystein; Dimmen, Sigbjorn

    2014-01-01

    Background The surgical approach in total hip arthroplasty (THA) is often based on surgeon preference and local traditions. The anterior muscle-sparing approach has recently gained popularity in Europe. We tested the hypothesis that patient satisfaction, pain, function, and health-related quality of life (HRQoL) after THA is not related to the surgical approach. Patients 1,476 patients identified through the Norwegian Arthroplasty Register were sent questionnaires 1–3 years after undergoing THA in the period from January 2008 to June 2010. Patient-reported outcome measures (PROMs) included the hip disability osteoarthritis outcome score (HOOS), the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), health-related quality of life (EQ-5D-3L), visual analog scales (VAS) addressing pain and satisfaction, and questions about complications. 1,273 patients completed the questionnaires and were included in the analysis. Results Adjusted HOOS scores for pain, other symptoms, activities of daily living (ADL), sport/recreation, and quality of life were significantly worse (p < 0.001 to p = 0.03) for the lateral approach than for the anterior approach and the posterolateral approach (mean differences: 3.2–5.0). These results were related to more patient-reported limping with the lateral approach than with the anterior and posterolateral approaches (25% vs. 12% and 13%, respectively; p < 0.001). Interpretation Patients operated with the lateral approach reported worse outcomes 1–3 years after THA surgery. Self-reported limping occurred twice as often in patients who underwent THA with a lateral approach than in those who underwent THA with an anterior or posterolateral approach. There were no significant differences in patient-reported outcomes after THA between those who underwent THA with a posterolateral approach and those who underwent THA with an anterior approach. PMID:24954494

  17. The Implementation of Patient-Reported Outcome Measures in Yoga Therapy.

    PubMed

    Ross, Alyson; Birdee, Gurjeet; Touchton-Leonard, Katharine; Bevans, Margaret

    2016-01-01

    Yoga therapists are interested in knowing whether their therapeutic interventions are helpful in improving health and wellbeing in their yoga therapy clients. However, few yoga therapists use standardized, reliable, and valid questionnaires to determine the therapeutic effectiveness of their treatments. Patient-reported outcome (PRO) measures are paper or web-based questionnaires used to assess an individual's perceptions of their symptoms and/or quality of life. In 2004, the National Institutes of Health (NIH) launched the PROMIS ® initiative to standardize and simplify the collection of PROs in research and in clinical practice. The PROMIS ® initiative launched a multicenter cooperative group that collected and reviewed thousands of PROs, then extensively tested them in over 20,000 research participants. The result was a web-based collection of item banks of the best questions or "items" within three domains of interest: physical, mental, and social health. These item banks are housed in the Assessment Center, a free online resource for collecting PROs. 1 Incorporating PROMIS ® outcomes into yoga therapy streamlines and optimizes the collection of PROs by enabling access to reliable and valid questionnaires that are easy to read, simple to complete, and are available in multiple languages as well as in both adult and pediatric versions. The use of standardized PROs may improve yoga therapy implementation in healthcare and accelerate translation of clinical research by allowing yoga therapists to conduct indepth symptom assessments using tools that allow for comparisons to other therapeutic clinical and research interventions. The purpose of this paper is to summarize the development of the NIH PROMIS ® initiative and to provide suggestions for incorporating PRO collection into yoga therapy. Important considerations to consider when implementing PROs into yoga therapy are discussed, including the choice of questionnaires and method of delivery (paper or web

  18. The Implementation of Patient-Reported Outcome Measures in Yoga Therapy.

    PubMed

    Ross, Alyson; Birdee, Gurjeet; Touchton-Leonard, Katharine; Bevans, Margaret

    2016-09-01

    Yoga therapists are interested in knowing whether their therapeutic interventions are helpful in improving health and wellbeing in their yoga therapy clients. However, few yoga therapists use standardized, reliable, and valid questionnaires to determine the therapeutic effectiveness of their treatments. Patient-reported outcome (PRO) measures are paper or web-based questionnaires used to assess an individual's perceptions of their symptoms and/or quality of life. In 2004, the National Institutes of Health (NIH) launched the PROMIS ® initiative to standardize and simplify the collection of PROs in research and in clinical practice. The PROMIS ® initiative launched a multicenter cooperative group that collected and reviewed thousands of PROs, then extensively tested them in over 20,000 research participants. The result was a web-based collection of item banks of the best questions or "items" within three domains of interest: physical, mental, and social health. These item banks are housed in the Assessment Center, a free online resource for collecting PROs. 1 Incorporating PROMIS ® outcomes into yoga therapy streamlines and optimizes the collection of PROs by enabling access to reliable and valid questionnaires that are easy to read, simple to complete, and are available in multiple languages as well as in both adult and pediatric versions. The use of standardized PROs may improve yoga therapy implementation in healthcare and accelerate translation of clinical research by allowing yoga therapists to conduct indepth symptom assessments using tools that allow for comparisons to other therapeutic clinical and research interventions. The purpose of this paper is to summarize the development of the NIH PROMIS ® initiative and to provide suggestions for incorporating PRO collection into yoga therapy. Important considerations to consider when implementing PROs into yoga therapy are discussed, including the choice of questionnaires and method of delivery (paper or web

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

    PubMed

    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

    2015-12-01

    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. 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. 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. Future work will include consensus exercises on what methods are required to ensure PROM are appropriate for people with low literacy and different cultures.

  20. 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

  1. Measuring engagement with music: development of an informant-report questionnaire.

    PubMed

    Vanstone, Ashley D; Wolf, Michael; Poon, Tina; Cuddy, Lola L

    2016-01-01

    This study describes the development of the Music Engagement Questionnaire (MusEQ), a 35-item scale to measure engagement with music in daily life. Music has implications for well-being and for therapy, notably for individuals living with dementia. A number of excellent scales or questionnaires are now available to measure music engagement. Unlike these scales, the MusEQ may be completed by either the participant or an informant. Study 1 drew on a community-based sample of 391 participants. Exploratory factor analysis revealed six interpretable factors, which formed the basis for construction of six subscales. Study 2 applied the MusEQ to a group of participants with Alzheimer's disease (AD; n = 16) as well as a group of neurotypical older adults (OA; n = 16). Informants completed the MusEQ, and the OA group also completed the self-report version of the MusEQ. Both groups had an interview in which they described the place music had in their lives. These interviews were scored by three independent raters. The MusEQ showed excellent internal consistency. Five of the factor-derived subscales showed good or excellent internal consistency. MusEQ scores were moderately correlated with a global rating of 'musicality' and with music education. There was strong agreement between self-report and informant-report data. MusEQ scores showed a significant positive relationship to independent ratings of music engagement. The MusEQ provides a meaningful and reliable option for measuring music engagement among participants who are unable to complete a self-report questionnaire.

  2. [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.

  3. Weight Bias: A Systematic Review of Characteristics and Psychometric Properties of Self-Report Questionnaires.

    PubMed

    Lacroix, Emilie; Alberga, Angela; Russell-Mathew, Shelly; McLaren, Lindsay; von Ranson, Kristin

    2017-01-01

    People living with overweight and obesity often experience weight-based stigmatization. Investigations of the prevalence and correlates of weight bias and evaluation of weight bias reduction interventions depend upon psychometrically-sound measurement. Our paper is the first to comprehensively evaluate the psychometric properties, use of people-first language within items, and suitability for use with various populations of available self-report measures of weight bias. We searched five electronic databases to identify English-language self-report questionnaires of weight bias. We rated each questionnaire's psychometric properties based on initial validation reports and subsequent use, and examined item language. Our systematic review identified 40 original self-report questionnaires. Most questionnaires were brief, demonstrated adequate internal consistency, and tapped key cognitive and affective dimensions of weight bias such as stereotypes and blaming. Current psychometric evidence is incomplete for many questionnaires, particularly with regard to the properties of test-retest reliability, sensitivity to change as well as discriminant and structural validity. Most questionnaires were developed prior to debate surrounding terminology preferences, and do not employ people-first language in the items administered to participants. We provide information and recommendations for clinicians and researchers in selecting psychometrically sound measures of weight bias for various purposes and populations, and discuss future directions to improve measurement of this construct. © 2017 The Author(s) Published by S. Karger GmbH, Freiburg.

  4. The relationship between the Leicester cough questionnaire, eosinophilic airway inflammation and asthma patient related outcomes in severe adult asthma.

    PubMed

    Natarajan, Sushiladevi; Free, Robert C; Bradding, Peter; McGarvey, Lorcan; Siddiqui, Salman

    2017-03-04

    Severe asthma is characterised by a variety of symptoms, which include chronic cough, however the mechanisms responsible for cough reflex hypersensitivity in asthma remain poorly elucidated. Current asthma patient-related outcome instruments such as the six-point Juniper Asthma Control Score (ACQ-6) and Asthma Quality of Life Questionnaire (AQLQ) were not primarily designed to capture cough and its related morbidity in asthma. The Leicester Cough Questionnaire (LCQ) is a patient-related outcome instrument designed to capture the health-related quality of life associated with cough. To date the LCQ has not been evaluated in a severe asthma population. We evaluated 262 extensively characterised adult patients with severe asthma attending the Leicester Severe Asthma Service. All patients had a clinician diagnosis of asthma and objective physiological evidence and met the ATS/ERS criterion for servere asthma. In all patients we evaluated a) the LCQ distribution and b) the relationships between the LCQ and ACQ-6, AQLQ, airway inflammation in sputum. The LCQ demonstrated the following properties; mean: 15.0, standard deviation: 4.54, median: 15.48, and range: 11.6-19.2. We found a moderate correlation between LCQ and ACQ-6 (r = - 0.605, p < 0.0001) and a LCQ and AQLQ (r = 0.710, p < 0.0001). There was no relationship between LCQ and log 10 sputum percentage eosinophils (%). A proportion of patients with severe asthma have a significant degree of cough-related morbidity that appears independent of eosinophilic airway inflammation and is not captured fully by existing asthma patient-reported outcome instruments. Our preliminary findings suggest that further research is now required to validate the LCQ and its responsiveness in severe asthma populations to capture cough-related morbidity and response to specific interventions.

  5. Development and Psychometric Evaluation of a Questionnaire Based on the Nursing Outcomes Classification to Determine the Knowledge of Parents on Breast-Feeding: Research Protocol.

    PubMed

    Paloma-Castro, Olga; Romero-Sánchez, José Manuel; Paramio-Cuevas, Juan Carlos; Pastor-Montero, Sonia María; Del Carmen Sánchez-Dalda, María; Rozadillas-Sanmiguel, Elena; Moreno-Corral, Luis Javier

    2017-04-01

    To develop and psychometrically evaluate a questionnaire based on the outcome "Knowledge: Breast-feeding" of the Nursing Outcomes Classification (NOC) to determine the knowledge of parents on breast-feeding. The NOC outcome "Knowledge: Breast-feeding" allows for nurses/midwives to assess the efficacy of interventions aimed to improve the knowledge on breast-feeding in parents thought the clinical interview/observation. However, the use of self-administered questionnaires by patients could facilitate its evaluation. Two-phased study: (1) Development of the questionnaire based on experts' opinions; (2) Methodological design to assess its psychometric properties. The availability of tools that enable the determination of the knowledge of patients would facilitate nurses/midwives to set objectives, individualize interventions, and measure their effectiveness. © 2015 NANDA International, Inc.

  6. 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…

  7. Living with a pacemaker: patient-reported outcome of a pacemaker system.

    PubMed

    Magnusson, Peter; Liv, Per

    2018-06-04

    The aim of this study was to assess among pacemaker patients their overall satisfaction with the pacemaker system, pain, soreness/discomfort, cosmetic results, restrictions due to impaired movement of the shoulder/arm/chest, related sleep disturbances, and concern about possible device malfunction. The seven-item questionnaire was mailed to patients from a single center who had a pacemaker implant or replacement between 2006 and 2016. A higher score indicated worse outcome on a visual analog scale (VAS) of 0-100 mm. The response rate was 75.5% and 342 questionniares were analyzed. Median age of respondents was 77.6 years and 57.0% were males. In total, 65 complications requiring surgery (10 pocket corrections (2.9%), 5 in females) occurred during a median follow-up of 5.6 years.The distribution of the primary outcome had a median score of 5 while the 75th percentile was 13. Cosmetic appearance was significantly associated with reoperation (but not other variables). Overall scores for men and women were 5 vs. 6, respectively, which achieved significance (p = 0.042). Median ratings of pain, soreness/discomfort, cosmetic appearance, range of motion, sleep, and concern about device malfunction were all ≤5. Females reported worse outcomes for all questions, except for cosmetic results and concern about malfunction. The vast majority of patients report excellent overall satisfaction with the pacemaker system, and are not affected by pain, soreness/discomfort, or concern about device malfunction. They also reported favourable outcomes with respect to cosmetic results, shoulder movement, and sleep. However, some patients underwent a surgical correction of the pacemaker pocket.

  8. The Chronic Obstructive Sialadenitis Symptoms Questionnaire to assess sialendoscopy-assisted surgery.

    PubMed

    Aubin-Pouliot, Annick; Delagnes, Elise A; Eisele, David W; Chang, Jolie L; Ryan, William R

    2016-01-01

    Introduce the Chronic Obstructive Sialadenitis Symptoms (COSS) questionnaire to quantify chronic sialadenitis symptoms and assess the impact of sialendoscopic-assisted salivary duct surgery (SASDS). Retrospective outcome symptoms questionnaire study. The COSS questionnaire assesses the severity of sialadenitis symptoms from 0 to 100. Patients who underwent SASDS from April 2006 to December 2013 completed the COSS questionnaire and the ShortForm8 Health Survey (SF-8) based on current symptoms, and reported whether they had complete, partial, or no symptomatic response to SASDS. Sixty-six of the 156 (43%) contacted patients completed the questionnaires who had had symptoms in 26 submandibular ducts and 53 parotid ducts. The mean COSS score was higher for parotid ducts (12.0; interquartile range [IQR] 1.0-20.0) than for submandibular ducts (7.6; IQR 0.5-15.0) but not significantly so (P = 0.20). Thirty-eight (60%) patients reported complete resolution of symptoms, with a mean COSS score of 4.5 (IQR 0-7). Twenty-one (33%) patients reported partial resolution, with a mean COSS score of 18.5 (IQR 11.3-22.8). Five (8%) patients reported no improvement, with a mean COSS score of 25.1 (IQR 15.2-35). Thirty-six (46%) ducts with sialoliths had a significantly lower mean COSS score (5.8; IQR 0-9.5) compared to those without sialoliths (14.2; IQR 4.5-21.5, P = 0.0004). There was no significant difference in SF-8 survey scores between these groups. The COSS questionnaire is a novel survey instrument to measure obstructive sialadenitis symptom severity that could be helpful in defining outcomes of SASDS. COSS scores under 10 correlate with complete resolution of symptoms, whereas scores between 10 and 25 correlate with partial resolution. © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

  9. Measuring health outcomes of a multidisciplinary care approach in individuals with chronic environmental conditions using an abbreviated symptoms questionnaire

    PubMed Central

    Fox, Roy; Sampalli, Tara; Fox, Jonathan

    2008-01-01

    The Nova Scotia Environmental Health Centre is a treatment facility for individuals with chronic environmental conditions such as multiple chemical sensitivity, chronic fatigue syndrome, fibromyalgia, chronic respiratory conditions and in some cases chronic pain. The premise of care is to provide a patient-centred multidisciplinary care approach leading to self-management strategies. In order to measure the outcome of the treatment in these complex problems, with overlapping diagnoses, symptoms in many body systems and suspected environmental triggers, a detailed symptoms questionnaire was developed specifically for this patient population and validated. Results from a pilot study in which an abbreviated symptoms questionnaire based on the top reported symptoms captured in previous research was used to measure the efficacy of a multidisciplinary care approach in individuals with multiple chemical sensitivity are presented in this paper. The purpose of this study was to examine the extent, type and patterns of changes over time in the top reported symptoms with treatment measured using the abbreviated symptoms questionnaire. A total of 183 active and 109 discharged patients participated in the study where the health status was measured at different time periods of follow up since the commencement of treatment at the Centre. The findings from this study were successful in generating an initial picture of the nature and type of changes in these symptoms. For instance, symptoms such as difficulty concentrating, sinus conditions and tiredness showed early improvement, within the first 6 months of being in treatment, while others, such as fatigue, hoarseness or loss of voice, took longer while others showed inconsistent changes warranting further enquiry. A controlled longitudinal study is planned to confirm the findings of the pilot study. PMID:21197341

  10. Favorable Responsiveness of the Hand10 Questionnaire to Assess Treatment Outcomes for Lateral Epicondylitis.

    PubMed

    Nishizuka, Takanobu; Iwatsuki, Katsuyuki; Kurimoto, Shigeru; Yamamoto, Michiro; Onishi, Tetsuro; Hirata, Hitoshi

    2018-06-01

    The aim of our study was to compare the responsiveness of the Hand10 questionnaire and the Pain visual analogue scale (VAS) for the assessment of lateral epicondylitis. The standardized response mean and effect size were used as indicators of responsiveness, measured at baseline and after 6 months of treatment. Among the 54 patients enrolled, 28 were treated using a forearm band, compress and stretching, with the other 26 patients treated using compress and stretching. The standardized response mean and the effect size were 1.18 and 1.38, respectively, of the Hand10 and 1.39 and 1.75, respectively, for the Pain VAS. The responsiveness of both tests was considered to be large, based on Cohen's classification of effect size, supporting the use of the Hand10 questionnaire to assess treatment outcomes for lateral epicondylitis.

  11. Focused Evidence Review: Psychometric Properties of Patient-Reported Outcome Measures for Chronic Musculoskeletal Pain.

    PubMed

    Goldsmith, Elizabeth S; Taylor, Brent C; Greer, Nancy; Murdoch, Maureen; MacDonald, Roderick; McKenzie, Lauren; Rosebush, Christina E; Wilt, Timothy J

    2018-05-01

    Developing successful interventions for chronic musculoskeletal pain requires valid, responsive, and reliable outcome measures. The Minneapolis VA Evidence-based Synthesis Program completed a focused evidence review on key psychometric properties of 17 self-report measures of pain severity and pain-related functional impairment suitable for clinical research on chronic musculoskeletal pain. Pain experts of the VA Pain Measurement Outcomes Workgroup identified 17 pain measures to undergo systematic review. In addition to a MEDLINE search on these 17 measures (1/2000-1/2017), we hand-searched (without publication date limits) the reference lists of all included studies, prior systematic reviews, and-when available-Web sites dedicated to each measure (PROSPERO registration CRD42017056610). Our primary outcome was the measure's minimal important difference (MID). Secondary outcomes included responsiveness, validity, and test-retest reliability. Outcomes were synthesized through evidence mapping and qualitative comparison. Of 1635 abstracts identified, 331 articles underwent full-text review, and 43 met inclusion criteria. Five measures (Oswestry Disability Index (ODI), Roland-Morris Disability Questionnaire (RMDQ), SF-36 Bodily Pain Scale (SF-36 BPS), Numeric Rating Scale (NRS), and Visual Analog Scale (VAS)) had data reported on MID, responsiveness, validity, and test-retest reliability. Seven measures had data reported on three of the four psychometric outcomes. Eight measures had reported MIDs, though estimation methods differed substantially and often were not clinically anchored. In this focused evidence review, the most evidence on key psychometric properties in chronic musculoskeletal pain populations was found for the ODI, RMDQ, SF-36 BPS, NRS, and VAS. Key limitations in the field include substantial variation in methods of estimating psychometric properties, defining chronic musculoskeletal pain, and reporting patient demographics. Registered in the PROSPERO

  12. Outcome selection and role of patient reported outcomes in contemporary cardiovascular trials: systematic review

    PubMed Central

    Malhotra, Aneil; Banning, Adrian P; Jenkinson, Crispin

    2010-01-01

    Objectives To systematically assess the type of outcomes selected and the prevalence of patient reported outcomes in contemporary cardiovascular trials and to quantify any misuse or underuse of patient reported outcomes using a specially developed tool that would allow estimation of the relevance of such outcomes to clinical decision making. Design Systematic review. Data sources Medline and Embase. Study selection Randomised controlled trials of the treatment for or prevention of cardiovascular disease published in 10 leading general medical and cardiology journals from January 2005 to December 2008. Results Primary outcomes were patient important (death, morbidity, or patient reported outcomes) in only 93 of 413 trials (23%, SE 2%), whereas another 92 (22%, SE 2%) combined these outcomes with other less important ones into a composite. Sixty five trials (16%; SE 2%) used at least one instrument to measure patient reported outcomes, mostly in trials where such information would have been important or crucial for clinical decision making (52 trials). Patient reported outcomes were judged to be of little incremental value to a large number of, mostly explanatory, cardiovascular trials (152 trials). However, many trials in which patient reported outcomes would have been important or crucial for clinical decision making did not report such outcomes (122 of 174 trials, 70%). These included several trials that primarily aimed to improve symptoms or functional status, trials that tested interventions with a considerable potential for causing harm (mainly bleeding) that were not meaningfully measured, and trials with composite outcomes that were dominated by outcomes of questionable importance to patients. Conclusions Despite a continued rise in the reporting of patient reported outcomes with no evidence for their misuse in more recent cardiovascular trials, they seem to be still underused once their relevance to clinical decision making has been taken into account. This

  13. Online self-report questionnaire on computer work-related exposure (OSCWE): validity and internal consistency.

    PubMed

    Mekhora, Keerin; Jalayondeja, Wattana; Jalayondeja, Chutima; Bhuanantanondh, Petcharatana; Dusadiisariyavong, Asadang; Upiriyasakul, Rujiret; Anuraktam, Khajornyod

    2014-07-01

    To develop an online, self-report questionnaire on computer work-related exposure (OSCWE) and to determine the internal consistency, face and content validity of the questionnaire. The online, self-report questionnaire was developed to determine the risk factors related to musculoskeletal disorders in computer users. It comprised five domains: personal, work-related, work environment, physical health and psychosocial factors. The questionnaire's content was validated by an occupational medical doctor and three physical therapy lecturers involved in ergonomic teaching. Twenty-five lay people examined the feasibility of computer-administered and the user-friendly language. The item correlation in each domain was analyzed by the internal consistency (Cronbach's alpha; alpha). The content of the questionnaire was considered congruent with the testing purposes. Eight hundred and thirty-five computer users at the PTT Exploration and Production Public Company Limited registered to the online self-report questionnaire. The internal consistency of the five domains was: personal (alpha = 0.58), work-related (alpha = 0.348), work environment (alpha = 0.72), physical health (alpha = 0.68) and psychosocial factor (alpha = 0.93). The findings suggested that the OSCWE had acceptable internal consistency for work environment and psychosocial factors. The OSCWE is available to use in population-based survey research among computer office workers.

  14. Challenging the reported disadvantages of e-questionnaires and addressing methodological issues of online data collection.

    PubMed

    Hunter, Louise

    2012-01-01

    To review the advantages and disadvantages of e-questionnaires, and question whether or not reported disadvantages remain valid or can be limited or circumvented. The internet is likely to become the dominant medium for survey distribution, yet nurses and midwives have been slow to use online technology for research involving questionnaires. Relatively little is known about optimal methods of harnessing the internet's potential in health studies. A small e-questionnaire of health workers. The Medline and Maternity and Infant Care databases were searched for articles containing the words 'web', 'online', or 'internet' and 'survey' or 'questionnaire'. The search was restricted to articles in English published since 2000. The reference lists of retrieved articles were also searched. Reported disadvantages of online data collection, such as sample bias, psychometric distortions, 'technophobia' and lower response rates are discussed and challenged. The author reports her experience of conducting a survey with an e-questionnaire to contribute to the limited body of knowledge in this area, and suggests how to maximise the quantity and quality of responses to e-questionnaires. E-questionnaires offer the researcher an inexpensive, quick and convenient way to collect data. Many of the reported disadvantages of the medium are no longer valid. The science of conducting the perfect e-survey is emerging. However, the lessons learned in the author's study, together with other research, seem to suggest that satisfactory response rates and data quality can be achieved in a relatively short time if certain tactics are used. To get the best results from e-questionnaires, it is suggested that the questionnaire recipients should be targeted carefully and that the value of their potential contribution to the project should be emphasised. E-questionnaires should be convenient, quick and easy to access, and be set out in a way that encourages full and complete responses.

  15. Radiation Therapy Versus No Radiation Therapy to the Neo-breast Following Skin-Sparing Mastectomy and Immediate Autologous Free Flap Reconstruction for Breast Cancer: Patient-Reported and Surgical Outcomes at 1 Year-A Mastectomy Reconstruction Outcomes Consortium (MROC) Substudy.

    PubMed

    Cooke, Andrew L; Diaz-Abele, Julian; Hayakawa, Tom; Buchel, Ed; Dalke, Kimberly; Lambert, Pascal

    2017-09-01

    To determine whether adjuvant radiation therapy (RT) is associated with adverse patient-reported outcomes and surgical complications 1 year after skin-sparing mastectomy and immediate autologous free flap reconstruction for breast cancer. We compared 24 domains of patient-reported outcome measures 1 year after autologous reconstruction between patients who received adjuvant RT and those who did not. A total of 125 patients who underwent surgery between 2012 and 2015 at our institution were included from the Mastectomy Reconstruction Outcomes Consortium study database. Adjusted multivariate models were created incorporating RT technical data, age, cancer stage, estrogen receptor, chemotherapy, breast size, body mass index, and income to determine whether RT was associated with outcomes. At 1 year after surgery, European Organisation for Research and Treatment of Cancer (EORTC) Breast Cancer-Specific Quality of Life Questionnaire breast symptoms were significantly greater in 64 patients who received RT (8-point difference on 100-point ordinal scale, P<.0001) versus 61 who did not receive RT in univariate and multivariate models. EORTC arm symptoms (20-point difference on 100-point ordinal scale, P=.0200) differed on univariate analysis but not on multivariate analysis. All other outcomes-including Numerical Pain Rating Scale, BREAST-Q (Post-operative Reconstruction Module), Patient-Report Outcomes Measurement Information System Profile 29, McGill Pain Questionnaire-Short Form (MPQ-SF) score, Generalized Anxiety Disorder Scale, and Patient Health Questionnaire-were not statistically different between groups. Surgical complications were uncommon and did not differ by treatment. RT to the neo-breast compared with no RT following immediate autologous free flap reconstruction for breast cancer is well tolerated at 1 year following surgery despite patients undergoing RT also having a higher cancer stage and more intensive surgical and systemic treatment. Neo

  16. A content validated questionnaire for assessment of self reported venous blood sampling practices

    PubMed Central

    2012-01-01

    Background Venous blood sampling is a common procedure in health care. It is strictly regulated by national and international guidelines. Deviations from guidelines due to human mistakes can cause patient harm. Validated questionnaires for health care personnel can be used to assess preventable "near misses"--i.e. potential errors and nonconformities during venous blood sampling practices that could transform into adverse events. However, no validated questionnaire that assesses nonconformities in venous blood sampling has previously been presented. The aim was to test a recently developed questionnaire in self reported venous blood sampling practices for validity and reliability. Findings We developed a questionnaire to assess deviations from best practices during venous blood sampling. The questionnaire contained questions about patient identification, test request management, test tube labeling, test tube handling, information search procedures and frequencies of error reporting. For content validity, the questionnaire was confirmed by experts on questionnaires and venous blood sampling. For reliability, test-retest statistics were used on the questionnaire answered twice. The final venous blood sampling questionnaire included 19 questions out of which 9 had in total 34 underlying items. It was found to have content validity. The test-retest analysis demonstrated that the items were generally stable. In total, 82% of the items fulfilled the reliability acceptance criteria. Conclusions The questionnaire could be used for assessment of "near miss" practices that could jeopardize patient safety and gives several benefits instead of assessing rare adverse events only. The higher frequencies of "near miss" practices allows for quantitative analysis of the effect of corrective interventions and to benchmark preanalytical quality not only at the laboratory/hospital level but also at the health care unit/hospital ward. PMID:22260505

  17. A content validated questionnaire for assessment of self reported venous blood sampling practices.

    PubMed

    Bölenius, Karin; Brulin, Christine; Grankvist, Kjell; Lindkvist, Marie; Söderberg, Johan

    2012-01-19

    Venous blood sampling is a common procedure in health care. It is strictly regulated by national and international guidelines. Deviations from guidelines due to human mistakes can cause patient harm. Validated questionnaires for health care personnel can be used to assess preventable "near misses"--i.e. potential errors and nonconformities during venous blood sampling practices that could transform into adverse events. However, no validated questionnaire that assesses nonconformities in venous blood sampling has previously been presented. The aim was to test a recently developed questionnaire in self reported venous blood sampling practices for validity and reliability. We developed a questionnaire to assess deviations from best practices during venous blood sampling. The questionnaire contained questions about patient identification, test request management, test tube labeling, test tube handling, information search procedures and frequencies of error reporting. For content validity, the questionnaire was confirmed by experts on questionnaires and venous blood sampling. For reliability, test-retest statistics were used on the questionnaire answered twice. The final venous blood sampling questionnaire included 19 questions out of which 9 had in total 34 underlying items. It was found to have content validity. The test-retest analysis demonstrated that the items were generally stable. In total, 82% of the items fulfilled the reliability acceptance criteria. The questionnaire could be used for assessment of "near miss" practices that could jeopardize patient safety and gives several benefits instead of assessing rare adverse events only. The higher frequencies of "near miss" practices allows for quantitative analysis of the effect of corrective interventions and to benchmark preanalytical quality not only at the laboratory/hospital level but also at the health care unit/hospital ward.

  18. Long-term Patient-Reported Outcomes in Postmastectomy Breast Reconstruction.

    PubMed

    Santosa, Katherine B; Qi, Ji; Kim, Hyungjin M; Hamill, Jennifer B; Wilkins, Edwin G; Pusic, Andrea L

    2018-06-20

    Previous outcome studies comparing implant and autologous breast reconstruction techniques have been limited by short-term follow-up, single-center design, and a lack of rigorous patient-reported outcome data. An understanding of the expected satisfaction and breast-related quality of life associated with each type of procedure is central to the decision-making process. To determine outcomes reported by patients undergoing postmastectomy breast reconstruction using implant or autologous techniques 2 years after surgery. Patients were recruited from 11 centers (57 plastic surgeons) across North America for the Mastectomy Reconstruction Outcomes Consortium study, a prospective, multicenter trial, from February 1, 2012, to July 31, 2015. Women undergoing immediate breast reconstruction using implant or autologous tissue reconstruction after mastectomy for cancer treatment or prophylaxis were eligible. Overall, 2013 women (1490 implant and 523 autologous tissue reconstruction) met the inclusion criteria. All patients included in this analysis had 2 years of follow-up. Procedure type (ie, implant vs autologous tissue reconstruction). The primary outcomes of interest were scores on the BREAST-Q, a validated, condition-specific, patient-reported outcome instrument, which were collected prior to and at 2 years after surgery. The following 4 domains of the BREAST-Q reconstruction module were evaluated: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being. Responses from each scale were summed and transformed on a 0 to 100 scale, with higher numbers representing greater satisfaction or quality of life. Of the 2013 women in the study (mean [SD] age, 48.1 [10.5] years for the group that underwent implant-based reconstruction and 51.6 [8.7] years for the group that underwent autologous reconstruction), 1217 (60.5%) completed questionnaires at 2 years after reconstruction. After controlling for baseline patient characteristics, patients

  19. Intraoperative ultrasound guidance in breast-conserving surgery shows superiority in oncological outcome, long-term cosmetic and patient-reported outcomes: Final outcomes of a randomized controlled trial (COBALT).

    PubMed

    Volders, J H; Haloua, M H; Krekel, N M A; Negenborn, V L; Kolk, R H E; Lopes Cardozo, A M F; Bosch, A M; de Widt-Levert, L M; van der Veen, H; Rijna, H; Taets van Amerongen, A H M; Jóźwiak, K; Meijer, S; van den Tol, M P

    2017-04-01

    The multicenter randomized controlled COBALT trial demonstrated that ultrasound-guided breast-conserving surgery (USS) results in a significant reduction of margin involvement (3.1% vs. 13%) and excision volumes compared to palpation-guided surgery (PGS). The aim of the present study was to determine long term oncological and patient-reported outcomes including quality of life (QoL), together with their progress over time. 134 patients with T1-T2 breast cancer were randomized to USS (N = 65) or PGS (N = 69). Cosmetic outcomes were assessed with the Breast Cancer Conservative Treatment cosmetic results (BCCT.core) software, panel-evaluation and patient self-evaluation on a 4-point Likert-scale. QoL was measured using the EORTC QLQ-C30/-BR23 questionnaire. No locoregional recurrences were reported after mean follow-up of 41 months. Seven patients (5%) developed distant metastatic disease (USS 6.3%, PGS 4.4%, p = 0.466), of whom six died of disease (95.5% overall survival). USS achieved better cosmetic outcomes compared to PGS, with poor outcomes of 11% and 21% respectively, a result mainly attributable to mastectomies due to involved margins following PGS. There was no difference after 1 and 3 years in cosmetic outcome. Dissatisfied patients included those with larger excision volumes, additional local therapies and worse QoL. Patients with poor/fair cosmetic outcomes scored significantly lower on aspects of QoL, including breast-symptoms, body image and sexual enjoyment. By significantly reducing positive margin status and lowering resection volumes, USS improves the rate of good cosmetic outcomes and increases patient-satisfaction. Considering the large impact of cosmetic outcome on QoL, USS has great potential to improve QoL following breast-conserving therapy. Copyright © 2016 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

  20. Patient satisfaction and self-reported outcomes after complete brachial plexus avulsion injury.

    PubMed

    Franzblau, Lauren E; Shauver, Melissa J; Chung, Kevin C

    2014-05-01

    Reconstructive surgery for complete brachial plexus avulsion injuries only partially restores function, and many patients are dissatisfied with results that surgeons consider good. Preoperative expectations have been shown to influence postoperative satisfaction but are poorly understood in patients with complete brachial plexus avulsion injuries. Qualitative methodology can elucidate patient beliefs and attitudes, which are difficult to quantify. The purpose of this study was to examine patient-reported outcomes, including satisfaction, and to understand the patient perspective. We used qualitative interviews and questionnaires to assess patient-reported outcomes. Two members of the research team analyzed interview data using Grounded Theory methodology. Data from participants who had and did not have reconstructive surgery were compared. Twelve patients participated in this study. Of the 7 participants who had reconstructive surgery, 4 felt their expectations had been met and 5 were satisfied with their outcomes. Reconstruction did not produce statistically significant improvements in upper extremity function, pain, or work ability. All patients reported dissatisfaction with upper extremity ability, and 9 expressed hope for innovative treatments (e.g., stem cell therapy, nerve reinsertion) that could potentially provide better outcomes than existing procedures and enable return to work. Satisfaction with surgical outcomes after complete avulsion brachial plexus injury depends heavily on whether preoperative expectations are met, but patients are unfamiliar with nerve avulsion and do not always know what to expect. Low satisfaction with upper extremity ability and the lack of statistically significant differences produced by reconstruction suggest that current treatments may not be meeting patients' needs. Physicians must provide robust preoperative education to encourage realistic expectations and direct patients toward resources for pain management to facilitate

  1. When do patient-reported outcome measures inform readmission risk?

    PubMed

    Hinami, Keiki; Smith, Jennifer; Deamant, Catherine D; DuBeshter, Kayle; Trick, William E

    2015-05-01

    To characterize changes in patient-reported outcome measures from hospital discharge to assess when they best inform risk of utilization as defined by readmissions or emergency department use. Patients discharged from an urban safety-net hospital. Longitudinal cohort study. We serially administered the Memorial Symptom Assessment Scale (MSAS) and the PROMIS Global Health short form assessing General Self-Rated Health (GSRH), Global Physical (GPH), and Mental (GMH) Health at 0, 30, 90, and 180 days from hospital discharge. Time to first utilization from each survey was plotted by dichotomizing our sample on each patient-reported measure, and equivalence of the time-to-event curves was assessed using the log-rank test. Cox proportional hazard models were used to control for available covariates including prior utilization during the study, Charlson score, age, gender, and race/ethnicity. We assessed each measure's effect on the fit of the predictive models using the likelihood ratio test. We recruited 196 patients, of whom 100%, 98%, 90%, and 88% completed each respective survey wave. Participants' mean age was 52 years, 51% were women, 60% were non-Hispanic black, and 21% completed the questionnaires in Spanish. In-hospital assessments revealed high symptom burden and poor health status. In-hospital assessments of GMH and GSRH predicted 14-day reutilization, whereas posthospitalization assessments of MSAS and GPH predicted subsequent utilizations. Each measure selectively improved predictive model fit. Routine measurement of patient-reported outcomes can help identify patients at higher risk for utilizations. At different time points, MSAS, GPH, GMH, and GSRH all informed utilization risk. © 2015 Society of Hospital Medicine.

  2. 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…

  3. A systematic review of measurement properties of patient reported outcome measures in psoriatic arthritis: A GRAPPA-OMERACT initiative.

    PubMed

    Højgaard, Pil; Klokker, Louise; Orbai, Ana-Maria; Holmsted, Kim; Bartels, Else M; Leung, Ying Ying; Goel, Niti; de Wit, Maarten; Gladman, Dafna D; Mease, Philip; Dreyer, Lene; Kristensen, Lars E; FitzGerald, Oliver; Tillett, William; Gossec, Laure; Helliwell, Philip; Strand, Vibeke; Ogdie, Alexis; Terwee, Caroline B; Christensen, Robin

    2018-04-01

    An updated psoriatic arthritis (PsA) core outcome set (COS) for randomized controlled trials (RCTs) was endorsed at the Outcome Measures in Rheumatology (OMERACT) meeting in 2016. To synthesize the evidence on measurement properties of patient reported outcome measures (PROMs) for PsA and thereby contribute to development of a PsA core outcome measurement set (COMS) as described by the OMERACT Filter 2.0. A systematic literature search was performed in EMBASE, MEDLINE and PsycINFO on Jan 1, 2017 to identify full-text articles with an aim of assessing the measurement properties of PROMs in PsA. Two independent reviewers rated the quality of studies using the COnsensus based standards for the Selection of health Measurement INstruments (COSMIN) checklist, and performed a qualitative evidence synthesis. Fifty-five studies were included in the systematic review. Forty-four instruments and a total of 89 scales were analyzed. PROMs measuring COS domains with at least fair quality evidence for good validity and reliability (and no evidence for poor properties) included the Stockerau Activity Score for PsA (German), Psoriasis Symptom Inventory, visual analogue scale for Patient Global, 36 Item Short Form Health Survey Physical Function subscale, Health Assessment Questionnaire Disability Index, Bath Ankylosing Spondylitis Functional Index, PsA Impact of Disease questionnaire, PsA Quality of Life questionnaire, VITACORA-19, Functional Assessment of Chronic Illness Therapy Fatigue scale and Social Role Participation Questionnaire. At least one PROM with some evidence for aspects of validity and reliability was available for six of the eight mandatory domains of the PsA COS. Copyright © 2018 Elsevier Inc. All rights reserved.

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

    PubMed

    Swigris, Jeffrey J; Fairclough, Diane

    2012-08-01

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

  5. A Systematic Review of Measurement Properties of Patient-Reported Outcome Measures Used in Patients Undergoing Total Knee Arthroplasty.

    PubMed

    Gagnier, Joel J; Mullins, Megan; Huang, Hsiaomin; Marinac-Dabic, Danica; Ghambaryan, Anna; Eloff, Benjamin; Mirza, Faisal; Bayona, Manuel

    2017-05-01

    While clinical research on total knee arthroplasty (TKA) outcomes is prevalent in the literature, studies often have poor methodological and reporting quality. A high-quality patient-reported outcome instrument is reliable, valid, and responsive. Many studies evaluate these properties, but none have done so with a systematic and accepted method. The objectives of this study were to identify patient-reported outcome measures (PROMs) for TKA, and to critically appraise, compare, and summarize their psychometric properties using accepted methods. MEDLINE, EMBASE, SCOPUS, Web of Science, PsycINFO, and SPORTDiscus were systematically searched for articles with the following inclusion criteria: publication before December 2014, English language, non-generic PRO, and evaluation in the TKA population. Methodological quality and evidence of psychometric properties were assessed with the COnsensus-based standards for the selection of health Status Measurement INstruments (COSMIN) checklist and criteria for psychometric evidence proposed by the COSMIN group and Terwee et al. One-hundred fifteen studies on 32 PROMs were included in this review. Only the Work, Osteoarthritis or joint-Replacement Questionnaire, the Oxford Knee Score, and the Western Ontario and McMaster Universities Arthritis Index had 4 or more properties with positive evidence. Most TKA PROMs have limited evidence for their psychometric properties. Although not all the properties were studied, the Work, Osteoarthritis or joint-Replacement Questionnaire, with the highest overall ratings, could be a useful PROM for evaluating patients undergoing TKA. The methods and reporting of this literature can improve by following accepted guidelines. Published by Elsevier Inc.

  6. On-demand Modafinil Improves Ejaculation Time and Patient-reported Outcomes in Men With Lifelong Premature Ejaculation.

    PubMed

    Tuken, Murat; Kiremit, Murat Can; Serefoglu, Ege Can

    2016-08-01

    To evaluate the effects of modafinil on the intravaginal ejaculatory latency time (IELT) and patient-reported outcomes in patients with lifelong premature ejaculation (PE). Treatment-naïve lifelong PE patients were included in this proof-of-concept study. Self-estimated IELTs of the patients were recorded and the Premature Ejaculation Profile (PEP) questionnaire was administered before the initiation of on-demand modafinil 100 mg treatment. At the end of 1 month of treatment, self-estimated IELTs were recorded again, along with posttreatment PEP outcomes. Overall, 55 lifelong PE patients with a mean age of 35.07 ± 7.80 (range: 22-58) years were enrolled. Modafinil treatment modestly increased the mean IELT at the end of 1 month (24.82 ± 16.10 seconds vs 49.82 ± 31.46 seconds, P = .0001). Moreover, at the end of 1 month, patients reported in the PEP questionnaire better control over ejaculation (0.75 ± 0.67 vs 1.35 ± 0.91, P = .0001), improved satisfaction with sexual intercourse (0.98 ± 0.78 vs 1.40 ± 0.85, P = .0001), lesser personal distress (0.42 ± 0.69 vs 0.89 ± 1.01, P = .0001), and reduced interpersonal difficulty (1.69 ± 1.48 vs 1.95 ± 1.47, P = .0001). In an uncontrolled proof-of-concept study of men with treatment-naïve lifelong PE where IELT was self-reported without a stopwatch, modest improvements of both IELT and patient-reported outcome measures were observed. Future controlled clinical trials are necessary to confirm these findings. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Prospective Patient-Related Outcome Evaluation of Secondary Cleft Rhinoplasty Using a Validated Questionnaire.

    PubMed

    Sawyer, Adam R; Robinson, Stephen; Cadier, Michael

    2017-07-01

    To evaluate patient satisfaction and quality of life following secondary cleft rhinoplasty. Prospective consecutive patient, single unit, single surgeon study. Spires Cleft Centre, Salisbury, Wilshire, United Kingdom, and private practice. 56 (27 secondary cleft rhinoplasty) patients completed evaluation forms preoperatively and 3 to 6 months postoperatively. Subjective assessment was performed using a validated Rhinoplasty Outcomes Evaluation (ROE) questionnaire. This instrument comprises six questions that capture three quality-of-life domains: physical, mental/emotional, and social. Rhinoplasty outcomes evaluation scores were calculated (range = 0 to 100) to indication satisfaction with rhinoplasty outcomes. Average age was 28 years (range = 18 to 59 years). There was a significant subjective improvement in the total ROE evaluation scores from 28 ± 10 to 80 ± 11 (P < .01) in secondary cleft rhinoplasty. Similar results were achieved in noncleft rhinoplasty 34 ± 9 to 84 ± 9 (P < .01). Specific scores for nasal aesthetic appearance improved from 0.3 ± 0.2 to 3.2 ± 0.3 (P < .01) in secondary cleft rhinoplasty. No significant change was seen in breathing capacity in secondary cleft rhinoplasty (from 2.7 ± 0.3 to 3.2 ± 0.2; P = .29). All patients said they would undergo the procedure again. Our results demonstrate high patient satisfaction after cleft rhinoplasty with particular regard to cosmetic appearance. These results are similar to those for noncleft rhinoplasty. We would recommend the use of this simple and quick validated outcome tool with all rhinoplasty patients.

  8. Upper limb dysfunction following selective neck dissection: a retrospective questionnaire study.

    PubMed

    Carr, Simon D; Bowyer, Duncan; Cox, Graham

    2009-06-01

    To determine total upper limb function following selective neck dissection over a mean follow-up of 1.6 years. A retrospective questionnaire study in a tertiary head and neck surgical unit. One hundred forty-eight patients who underwent selective neck dissection for head and neck cancer from January 2000 to December 2005 were invited to participate. The main outcome measure was ipsilateral upper limb dysfunction as measured by the Disability of Arm, Shoulder and Hand (DASH) questionnaire. Sixty-five patients responded to the invitation to join the study from 148 invited. Despite accessory nerve conserving surgery for all the selective neck dissections studied, 23% reported no upper limb dysfunction, 54% reported mild upper limb dysfunction, 15% reported moderate, and 8% reported a severe dysfunction. Long-term upper limb dysfunction is common following nerve preserving surgery. The DASH questionnaire is a useful preoperative and postoperative clinical tool for those patients undergoing selective neck dissections. (c) 2009 Wiley Periodicals, Inc.

  9. Is patient responsibility for managing musculoskeletal disorders related to self-reported better outcome of physiotherapy treatment?

    PubMed

    Larsson, Maria E H; Kreuter, Margareta; Nordholm, Lena

    2010-07-01

    Musculoskeletal disorders are prevalent and a major burden on individuals and society. Information on relationships of patient involvement and responsibility to outcome is limited. This study aimed to explore relationships between self-reported outcome of physiotherapy treatment and attitudes toward responsibility for musculoskeletal disorders. A cross-sectional postal survey design was used. Patients (n=615) from an outpatient physiotherapy clinic, who had finished their physiotherapy treatment within the last 6 months were sent a questionnaire that included the Attitudes regarding Responsibility for Musculoskeletal disorders instrument (ARM), self-reported outcome of treatment and sociodemographic data. A total of 279 (45%) completed forms were returned. Multiple logistic regression analysis was used. The patients' scores on the four dimensions of ARM ("responsibility self active," "responsibility out of my hands," "responsibility employer," and "responsibility medical professionals"), controlled for age, sex, education, and physical activity as well as for number of treatments, main treatment, and physiotherapist, were associated with the patients' self-reported treatment outcome. Patients who attributed responsibility more to themselves were more likely (OR 2.37 and over) to report considerable improvement as the outcome of physiotherapy treatment. Because this study was conducted at only one physiotherapy outpatient clinic and had a cross-sectional design, the results should be replicated in other settings. Because patients' attitudes regarding responsibility for musculoskeletal disorders can possibly affect the outcome of physiotherapy treatment, it might be useful to decide whether to systematically try to influence the person's attitude toward responsibility for the management of the disorder or to match treatment to attitude.

  10. One size doesn't fit all: time to revisit patient-reported outcome measures (PROMs) in paediatric ophthalmology?

    PubMed Central

    Tadić, V; Rahi, J S

    2017-01-01

    The purpose of this article is to summarise methodological challenges and opportunities in the development and application of patient reported outcome measures (PROMs) for the rare and complex population of children with visually impairing disorders. Following a literature review on development and application of PROMs in children in general, including those with disabilities and or/chronic condition, we identified and discuss here 5 key issues that are specific to children with visual impairment: (1) the conflation between theoretically distinct vision-related constructs and outcomes, (2) the importance of developmentally appropriate approaches to design and application of PROMs, (3) feasibility of standard questionnaire formats and administration for children with different levels of visual impairment, (4) feasibility and nature of self-reporting by visually impaired children, and (5) epidemiological, statistical and ethical considerations. There is an established need for vision-specific age-appropriate PROMs for use in paediatric ophthalmology, but there are significant practical and methodological challenges in developing and applying appropriate measures. Further understanding of the characteristics and needs of visually impaired children as questionnaire respondents is necessary for development of quality PROMs and their meaningful application in clinical practice and research. PMID:28085146

  11. Use of the Godin leisure-time exercise questionnaire in multiple sclerosis research: a comprehensive narrative review.

    PubMed

    Sikes, Elizabeth Morghen; Richardson, Emma V; Cederberg, Katie J; Sasaki, Jeffer E; Sandroff, Brian M; Motl, Robert W

    2018-01-17

    The Godin Leisure-Time Exercise Questionnaire has been a commonly applied measure of physical activity in research among persons with multiple sclerosis over the past decade. This paper provides a comprehensive description of its application and inclusion in research on physical activity in multiple sclerosis. This comprehensive, narrative review included papers that were published between 1985 and 2017, written in English, involved participants with multiple sclerosis as a primary population, measured physical activity, and cited one of the two original Godin papers. There is a broad scope of research that has included the Godin Leisure-Time Exercise Questionnaire in persons with multiple sclerosis. Overall, 8 papers evaluated its psychometric properties, 21 evaluated patterns of physical activity, 24 evaluated correlates or determinants of physical activity, 28 evaluated outcomes or consequences of physical activity, and 15 evaluated physical activity interventions. The Godin Leisure-Time Exercise Questionnaire is a valid self-report measure of physical activity in persons with multiple sclerosis, and further is an appropriate, simple, and effective tool for describing patterns of physical activity, examining correlates and outcomes of physical activity, and provides a sensitive outcome for measuring change in physical activity after an intervention. Implications for rehabilitation There is increasing interest in physical activity and its benefits in multiple sclerosis. The study of physical activity requires appropriate and standardized measures. The Godin Leisure-Time Exercise Questionnaire is a common self-report measure of physical activity for persons with multiple sclerosis. Godin Leisure-Time Exercise Questionnaire scores are reliable measures of physical activity in persons with multiple sclerosis. The Godin Leisure-Time Exercise Questionnaire further is an appropriate, simple, and effective tool for describing patterns of physical activity, examining

  12. Outcome measurement in Australian rehabilitation environments.

    PubMed

    Douglas, Heather; Swanson, Cheryl; Gee, Travis; Bellamy, Nicholas

    2005-09-01

    To determine the frequency and pattern of methods of outcome assessment used in Australian physical rehabilitation environments. Postal survey. A questionnaire on service type, staffing, numbers of adults treated and outcome measures used for 7 conditions related to injury and road trauma as well as stroke and neuromuscular disorders was sent to 973 services providing adult physical rehabilitation treatment. Questionnaires were completed by 440 service providers for a response rate of 45%, similar to that reported in a recent European survey reported in this journal. A small number of measures were reported as in use by most respondents, while a large number of measures were used by a few respondents. Measures of physical changes were used more frequently than those of generic well-being or quality of life. Ease of use and reporting to other professionals were cited as the most important reasons in selection of outcome measures. This Australian-wide survey detected considerable heterogeneity in outcome measurement procedures used in rehabilitation environments. While the goal of measurement may vary between providers and differ between conditions, the results highlight opportunities for harmonization, bench-marking and measurement of health-related quality of life.

  13. Patient-reported outcomes as predictors of 10-year survival in women after acute myocardial infarction

    PubMed Central

    2010-01-01

    Background Patient-reported outcomes are increasingly seen as complementary to biomedical measures. However, their prognostic importance has yet to be established, particularly in female long-term myocardial infarction (MI) survivors. We aimed to determine whether 10-year survival in older women after MI relates to patient-reported outcomes, and to compare their survival with that of the general female population. Methods We included all women aged 60-80 years suffering MI during 1992-1997, and treated at one university hospital in Norway. In 1998, 145 (60% of those alive) completed a questionnaire package including socio-demographics, the Sense of Coherence Scale (SOC-29), the World Health Organization Quality of Life Instrument Abbreviated (WHOQOL-BREF) and an item on positive effects of illness. Clinical information was based on self-reports and hospital medical records data. We obtained complete data on vital status. Results The all-cause mortality rate during the 1998-2008 follow-up of all patients was 41%. In adjusted analysis, the conventional predictors s-creatinine (HR 1.26 per 10% increase) and left ventricular ejection fraction below 30% (HR 27.38), as well as patient-reported outcomes like living alone (HR 6.24), dissatisfaction with self-rated health (HR 6.26), impaired psychological quality of life (HR 0.60 per 10 points difference), and experience of positive effects of illness (HR 6.30), predicted all-cause death. Major adverse cardiac and cerebral events were also significantly associated with both conventional predictors and patient-reported outcomes. Sense of coherence did not predict adverse events. Finally, 10-year survival was not significantly different from that of the general female population. Conclusion Patient-reported outcomes have long-term prognostic importance, and should be taken into account when planning aftercare of low-risk older female MI patients. PMID:21108810

  14. Patient-reported outcomes as predictors of 10-year survival in women after acute myocardial infarction.

    PubMed

    Norekvål, Tone M; Fridlund, Bengt; Rokne, Berit; Segadal, Leidulf; Wentzel-Larsen, Tore; Nordrehaug, Jan Erik

    2010-11-25

    Patient-reported outcomes are increasingly seen as complementary to biomedical measures. However, their prognostic importance has yet to be established, particularly in female long-term myocardial infarction (MI) survivors. We aimed to determine whether 10-year survival in older women after MI relates to patient-reported outcomes, and to compare their survival with that of the general female population. We included all women aged 60-80 years suffering MI during 1992-1997, and treated at one university hospital in Norway. In 1998, 145 (60% of those alive) completed a questionnaire package including socio-demographics, the Sense of Coherence Scale (SOC-29), the World Health Organization Quality of Life Instrument Abbreviated (WHOQOL-BREF) and an item on positive effects of illness. Clinical information was based on self-reports and hospital medical records data. We obtained complete data on vital status. The all-cause mortality rate during the 1998-2008 follow-up of all patients was 41%. In adjusted analysis, the conventional predictors s-creatinine (HR 1.26 per 10% increase) and left ventricular ejection fraction below 30% (HR 27.38), as well as patient-reported outcomes like living alone (HR 6.24), dissatisfaction with self-rated health (HR 6.26), impaired psychological quality of life (HR 0.60 per 10 points difference), and experience of positive effects of illness (HR 6.30), predicted all-cause death. Major adverse cardiac and cerebral events were also significantly associated with both conventional predictors and patient-reported outcomes. Sense of coherence did not predict adverse events. Finally, 10-year survival was not significantly different from that of the general female population. Patient-reported outcomes have long-term prognostic importance, and should be taken into account when planning aftercare of low-risk older female MI patients.

  15. Smallest detectable change and test-retest reliability of a self-reported outcome measure: Results of the Center for Epidemiologic Studies Depression Scale, General Self-Efficacy Scale, and 12-item General Health Questionnaire.

    PubMed

    Ohno, Shotaro; Takahashi, Kana; Inoue, Aimi; Takada, Koki; Ishihara, Yoshiaki; Tanigawa, Masaru; Hirao, Kazuki

    2017-12-01

    This study aims to examine the smallest detectable change (SDC) and test-retest reliability of the Center for Epidemiologic Studies Depression Scale (CES-D), General Self-Efficacy Scale (GSES), and 12-item General Health Questionnaire (GHQ-12). We tested 154 young adults at baseline and 2 weeks later. We calculated the intra-class correlation coefficients (ICCs) for test-retest reliability with a two-way random effects model for agreement. We then calculated the standard error of measurement (SEM) for agreement using the ICC formula. The SEM for agreement was used to calculate SDC values at the individual level (SDC ind ) and group level (SDC group ). The study participants included 137 young adults. The ICCs for all self-reported outcome measurement scales exceeded 0.70. The SEM of CES-D was 3.64, leading to an SDC ind of 10.10 points and SDC group of 0.86 points. The SEM of GSES was 1.56, leading to an SDC ind of 4.33 points and SDC group of 0.37 points. The SEM of GHQ-12 with bimodal scoring was 1.47, leading to an SDC ind of 4.06 points and SDC group of 0.35 points. The SEM of GHQ-12 with Likert scoring was 2.44, leading to an SDC ind of 6.76 points and SDC group of 0.58 points. To confirm that the change was not a result of measurement error, a score of self-reported outcome measurement scales would need to change by an amount greater than these SDC values. This has important implications for clinicians and epidemiologists when assessing outcomes. © 2017 John Wiley & Sons, Ltd.

  16. Long-term patient-reported outcome after fractures of the clavicle in patients aged 10 to 18 years.

    PubMed

    Randsborg, Per-Henrik; Fuglesang, Hendrik F S; Røtterud, Jan H; Hammer, Ola-Lars; Sivertsen, Einar A

    2014-06-01

    Fractures of the clavicle are common among adolescents and have traditionally been treated nonoperatively. Recent literature has demonstrated less satisfactory results than expected after conservative management of displaced fractures in adults. The purpose of this study was to evaluate the long-term patient-reported outcome after clavicle fractures in older children and adolescents. Children aged 10 to 18 years who sustained a fracture of the clavicle between 2006 and 2008 were identified in our institution's computerized files. The radiographs were examined and the fracture patterns, degree of dislocation, and shortening were measured. Medical records were reviewed and the patient-reported outcome was assessed using the Oxford Shoulder score and the Quick version of the Disability of Arm, Shoulder, and Hand questionnaire, and specific and general satisfaction scores. A total of 185 patients (median age, 14.4 y) with 172 midshaft and 13 lateral fractures were included in the study. Sixty-five (37.8%) of the midshaft fractures were displaced, and 9 of these were operated. There was one case of nonunion and one delayed union. One hundred twenty-two (70.9%) of the patients with a midshaft fracture responded to the questionnaires on an average 4.7 years after injury. Overall results were good to excellent for the majority of nonoperatively treated patients; however, shortening of the fracture had a negative effect on the Oxford Shoulder score (P=0.02), the cosmetic satisfaction score (P=0.02), and the overall satisfaction score (P=0.01). The long-term patient-reported outcome after nonoperatively treated fractures of the clavicle in adolescents is good to excellent for the majority of the patients, and nonunion is rare. However, shortening of the fracture had a small negative effect on the outcome. Conservative management should remain the mainstay of management for fractures of the clavicle in this age group. Level IV-retrospective case series.

  17. Patient-Reported Outcome and Observer-Reported Outcome Assessment in Rare Disease Clinical Trials: An ISPOR COA Emerging Good Practices Task Force Report.

    PubMed

    Benjamin, Katy; Vernon, Margaret K; Patrick, Donald L; Perfetto, Eleanor; Nestler-Parr, Sandra; Burke, Laurie

    Rare diseases (RDs) affect a small number of people within a population. About 5000 to 8000 distinct RDs have been identified, with an estimated 6% to 8% of people worldwide suffering from an RD. Approximately 75% of RDs affect children. Frequently, these conditions are heterogeneous; many are progressive. Regulatory incentives have increased orphan drug designations and approvals. To develop emerging good practices for RD outcomes research addressing the challenges inherent in identifying, selecting, developing, adapting, and implementing patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments for use in RD clinical trials. This report outlines the challenges and potential solutions in determining clinical outcomes for RD trials. It follows the US Food and Drug Administration Roadmap to Patient-Focused Outcome Measurement in Clinical Trials. The Roadmap consists of three columns: 1) Understanding the Disease or Condition, 2) Conceptualizing Treatment Benefit, and 3) Selecting/Developing the Outcome Measure. Challenges in column 1 include factors such as incomplete natural history data and heterogeneity of disease presentation and patient experience. Solutions include using several information sources, for example, clinical experts and patient advocacy groups, to construct the condition's natural history and understand treatment patterns. Challenges in column 2 include understanding and measuring treatment benefit from the patient's perspective, especially given challenges in defining the context of use such as variations in age or disease severity/progression. Solutions include focusing on common symptoms across patient subgroups, identifying short-term outcomes, and using multiple types of COA instruments to measure the same constructs. Challenges in column 3 center around the small patient population and heterogeneity of the condition or study sample. Few disease-specific instruments for RDs exist. Strategies include adapting existing

  18. Development and psychometric testing of the Canine Owner-Reported Quality of Life questionnaire, an instrument designed to measure quality of life in dogs with cancer.

    PubMed

    Giuffrida, Michelle A; Brown, Dorothy Cimino; Ellenberg, Susan S; Farrar, John T

    2018-05-01

    OBJECTIVE To describe development and initial psychometric testing of an owner-reported questionnaire designed to standardize measurement of general quality of life (QOL) in dogs with cancer. DESIGN Key-informant interviews, questionnaire development, and field trial. SAMPLE Owners of 25 dogs with cancer for item development and pretesting and owners of 90 dogs with cancer for reliability and validity testing. PROCEDURES Standard methods for development and testing of questionnaire instruments intended to measure subjective states were used. Items were generated, selected, scaled, and pretested for content, meaning, and readability. Response items were evaluated with exploratory factor analysis and by assessing internal consistency (Cronbach α) and convergence with global QOL as determined with a visual analog scale. Preliminary tests of stability and responsiveness were performed. RESULTS The final questionnaire-which was named the Canine Owner-Reported Quality of Life (CORQ) questionnaire-contained 17 items related to observable behaviors commonly used by owners to evaluate QOL in their dogs. Several items pertaining to physical symptoms performed poorly and were omitted. The 17 items were assigned to 4 factors-vitality, companionship, pain, and mobility-on the basis of the items they contained. The CORQ questionnaire and its factors had high internal consistency (Cronbach α = 0.68 to 0.90) and moderate to strong correlations (r = 0.49 to 0.71) with global QOL as measured on a visual analog scale. Preliminary testing indicated good test-retest reliability and responsiveness to improvements in overall QOL. CONCLUSIONS AND CLINICAL RELEVANCE The CORQ questionnaire was a valid, reliable owner-reported questionnaire that measured general QOL in dogs with cancer and showed promise as a clinical trial outcome measure for quantifying changes in individual dog QOL occurring in response to cancer treatment and progression.

  19. Patient reported outcome measures (PROMs) for goalsetting and outcome measurement in primary care physiotherapy, an explorative field study.

    PubMed

    van Dulmen, Simone A; van der Wees, Philip J; Bart Staal, J; Braspenning, J C C; Nijhuis-van der Sanden, Maria W G

    2017-03-01

    Routine use of patient reported outcome measures (PROMs) may provide an effective way of monitoring patient valued outcomes. In this study we explored (1) the current use of PROMs; (2) to what extent the goals correspond with the selected PROMs; (3) the health outcomes based on PROMs. Observational clinical cohort study. Dutch primary care physiotherapy practices (n=43). Patients (n=299) with neck pain or low back pain. The number of PROMs used per patient were calculated. The International Classification of Functioning, Disability and Health was used to map the patients' goals and the percentages of PROMS selected that match the domains of the goals were calculated. Health outcomes were assessed using two approaches for estimating the minimal clinically important difference (MCID). Repeated measurements with the Visual Analogue Scale, the Patient Specific Complaints questionnaire, the Quebec Back Pain Disability Scale, or the Neck Disability Index were completed by more than 60% of the patients. The PROMs used matched in 46% of the cases with goals for pain improvement, and in 43% with goals set at activity/participation level. The mean differences between baseline and follow up scores for all PROMs were statistically significant. Improvements of patients based on MCID varied from 57% to 90%. PROMs were used in the majority of the patients, showed improved health outcomes and fitted moderately with goals. The results of this study can be used for future research assessing the routine use of outcome measurements with PROMs. Copyright © 2016 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  20. Does CPAP Affect Patient-Reported Voice Outcomes?

    PubMed

    Hartke, Vance; Gillespie, Amanda; Smith, Libby J; Soose, Ryan J

    2018-04-01

    Upper aerodigestive tract symptoms are common in patients with obstructive sleep apnea (OSA). It remains unclear whether continuous positive airway pressure (CPAP) improves or worsens these otolaryngology symptoms. As therapy-related side effects limit CPAP adherence, this study aimed to determine if CPAP negatively affects voice, sinonasal, and reflux symptoms of the upper airway. Case series with planned data collection was performed at an academic otolaryngology sleep center. Newly diagnosed patients with OSA were evaluated before and 6 months after initiating CPAP therapy. Data collected included CPAP data download, Reflux Symptom Index (RSI), Epworth Sleepiness Scale (ESS), Voice Handicap Index 10 (VHI-10), Sino-Nasal Questionnaire (SNQ), and oral dryness visual analog scale (VAS). For the 11 CPAP-adherent participants, the RSI significantly improved with CPAP (mean RSI, 22.0-9.5; P = .002); however, the VAS, VHI-10, and SNQ did not change after 6 months of CPAP therapy. In a small sample size, patient-reported voice outcomes (VHI-10) and other upper aerodigestive tract symptoms did not worsen with CPAP; rather, CPAP therapy was associated with a reduction in reflux symptoms.

  1. Screening for oropharyngeal dysphagia in older adults: A systematic review of self-reported questionnaires.

    PubMed

    Magalhães Junior, Hipólito V; Pernambuco, Leandro de Araújo; Lima, Kenio C; Ferreira, Maria Angela F

    2018-04-03

    Oropharyngeal dysphagia is a swallowing disorder with signs and symptoms which may be present in older adults, but they are rarely noticed as a health concern by older people. The earliest possible identification of this clinical condition is needed by self-reported population-based screening questionnaire, which are valid and reliable for preventing risks to nutritional status, increased morbidity and mortality. The aim of this systematic review was to identify self-reported screening questionnaires for oropharyngeal dysphagia in older adults to evaluate their methodological quality for population-based studies. An extensive search of electronic databases (PubMed (MEDLINE), Ovid MEDLINE(R), Scopus, Cochrane Library, CINAHL, Web of Science (WOS), PsycINFO (APA), Lilacs and Scielo) was conducted in the period from April to May 2017 using previously established search strategies by the two evaluators. The methodological quality and the psychometric properties of the included studies were evaluated by the COSMIN (Consensus based Standards for the selection of health Measurement Instruments) checklist and the quality criteria of Terwee and colleagues, respectively. The analysed information was extracted from three articles which had conducted studies on the prevalence of oropharyngeal dysphagia by self-reported screening questionnaires, showing poor methodological quality and flaws in the methodological description to demonstrate its psychometric properties. This study did not find any self-reported screening questionnaires for oropharyngeal dysphagia with suitable methodological quality and appropriate evidence in its psychometric properties for elders. Therefore, the self-reported questionnaires within the diagnostic proposal require greater details in its process for obtaining valid and reliable evidence. © 2018 John Wiley & Sons A/S and The Gerodontology Association. Published by John Wiley & Sons Ltd.

  2. An Electronic Patient-Reported Outcome Measures System in UK Chiropractic Practices: A Feasibility Study of Routine Collection of Outcomes and Costs.

    PubMed

    Newell, Dave; Diment, Emily; Bolton, Jenni E

    2016-01-01

    The purpose of this study was to test the feasibility of collecting valid and widely used health outcomes, including information concerning cost of care, using a Web-based patient-driven patient-reported outcome measure (PROM) collection process within a cohort of UK chiropractic practices. A Web-based PROM system (Care Response) was used. Patients with low back and neck pain were recruited from a group of chiropractic practices located in the United Kingdom. Information collected included demographic data, generic and condition-specific PROMs at the initial consultation and 90 days later, patient-reported experience measures, and additional health seeking to estimate costs of care. A group of 33 clinics provided information from a total of 1895 patients who completed baseline questionnaires with 844 (45%) completing the measures at 90-day follow-up. Subsequent outcomes suggest that more than 70% of patients improved over the course of treatment regardless of the outcome used. Using the baseline as a virtual counterfactual with respect to follow-up, we calculated quality-adjusted life years and the cost thereof resulting in a mean quality-adjusted life years gained of 0.8 with an average cost of £895 per quality-adjusted life year. Routine collection of PROMs, including information about cost, is feasible and can be achieved using an online system within a clinical practice environment. We describe a Web-based collection system and discuss the choice of measures leading to a comprehensive understanding of outcomes and costs in routine practice. Copyright © 2016 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.

  3. Reporting combined outcomes with Trifecta and survival, continence, and potency (SCP) classification in 337 patients with prostate cancer treated with image-guided hypofractionated radiotherapy.

    PubMed

    Jereczek-Fossa, Barbara A; Zerini, Dario; Fodor, Cristiana; Santoro, Luigi; Maucieri, Andrea; Gerardi, Marianna A; Vischioni, Barbara; Cambria, Raffaella; Garibaldi, Cristina; Cattani, Federica; Vavassori, Andrea; Matei, Deliu V; Musi, Gennaro; De Cobelli, Ottavio; Orecchia, Roberto

    2014-12-01

    To report the image-guided hypofractionated radiotherapy (hypo-IGRT) outcome for patients with localised prostate cancer according to the new outcome models Trifecta (cancer control, urinary continence, and sexual potency) and SCP (failure-free survival, continence and potency). Between August 2006 and January 2011, 337 patients with cT1-T2N0M0 prostate cancer (median age 73 years) were eligible for a prospective longitudinal study on hypo-IGRT (70.2 Gy/26 fractions) in our Department. Patients completed four questionnaires before treatment, and during follow-up: the International Index of Erectile Function-5 (IIEF-5), the International Prostate Symptom Score (IPSS), and the European Organization for Research and Treatment of Cancer prostate-cancer-specific Quality of Life Questionnaires (QLQ) QLQ-PR25 and QLQ-C30. Baseline and follow-up patient data were analysed according to the Trifecta and SCP outcome models. Cancer control, continence and potency were defined respectively as no evidence of disease, score 1 or 2 for item 36 of the QLQ-PR25 questionnaire, and total score of >16 on the IIEF-5 questionnaire. Patients receiving androgen-deprivation therapy (ADT) at any time were excluded. Trifecta criteria at baseline were met in 72 patients (42% of all ADT-free patients with completed questionnaires). Both at 12 and 24 months after hypo-IGRT, 57% of the Trifecta patients at baseline were still meeting the Trifecta criteria (both oncological and functional success according to the SCP model). The main reason for failing the Trifecta criteria during follow-up was erectile dysfunction: in 18 patients after 6 months follow-up, in 12 patients after 12 months follow-up, and in eight patients after 24 months. Actuarial 2-year Trifecta failure-free survival rate was 44% (95% confidence interval 27-60%). In multivariate analysis no predictors of Trifecta failure were identified. Missing questionnaires was the main limitation of the study. The Trifecta and SCP

  4. The PROMIS Global Health Questionnaire Correlates With the QuickDASH in Patients With Upper Extremity Illness.

    PubMed

    Stoop, Nicky; Menendez, Mariano E; Mellema, Jos J; Ring, David

    2018-01-01

    The objective of this study is to evaluate the construct validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health instrument by establishing its correlation to the Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire in patients with upper extremity illness. A cohort of 112 patients completed a sociodemographic survey and the PROMIS Global Health and QuickDASH questionnaires. Pearson correlation coefficients were used to evaluate the association of the QuickDASH with the PROMIS Global Health items and subscales. Six of the 10 PROMIS Global Health items were associated with the QuickDASH. The PROMIS Global Physical Health subscale showed moderate correlation with QuickDASH and the Mental Health subscale. There was no significant relationship between the PROMIS Global Mental Health subscale and QuickDASH. The consistent finding that general patient-reported outcomes correlate moderately with regional patient-reported outcomes suggests that a small number of relatively nonspecific patient-reported outcome measures might be used to assess a variety of illnesses. In our opinion, the blending of physical and mental health questions in the PROMIS Global Health makes this instrument less useful for research or patient care.

  5. 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

  6. [Optimized assessment of the outcome in patients with radicular back pain of the lumbar spine. The modified NASS questionnaire].

    PubMed

    Janousek, M; Ferrari, S; Schmid, U D; Bischoff, H A; Balsiger, M; Theiler, R

    2011-09-01

    The purpose of the study was to present a reliable instrument with easy application to assess the outcome and improvement of therapy in patients with radicular symptoms of the lumbar spine. Data from patients who underwent microdiscectomy because of lumbar radicular symptoms were collected and analyzed and interviews were performed using the well-known North American Spine Society (NASS) lumbar spine questionnaire (17 items) before and after the intervention. In addition patient data including comorbidities were collected. By calculating effect size (ES) and standardized response mean (SRM) for each item of the questionnaire, the questions with the highest change before and after the intervention could be selected. A total of 139 patients undergoing microdiscectomy for lumbar radicular symptoms due to a disc herniation were included in the analysis. Concerning the three dimensions pain, neurological symptoms and impairment of activities in daily life, the questions with best predictive value (high ES and SRM) were selected. According to their clinical relevance eight questions of the NASS questionnaire were finally selected for the short form. This short, significant and easy to use questionnaire is in our opinion a useful instrument to assess the course of patients with radicular back pain and especially to measure and monitor the outcome of therapeutic interventions, in addition to conventional clinical diagnostics and examinations. This novel instrument could be a useful tool for improving quality assurance in conventional and interventional pain management of these patients.

  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. Updating the OMERACT filter: implications for patient-reported outcomes.

    PubMed

    Kirwan, John R; Bartlett, Susan J; Beaton, Dorcas E; Boers, Maarten; Bosworth, Ailsa; Brooks, Peter M; Choy, Ernest; de Wit, Maarten; Guillemin, Francis; Hewlett, Sarah; Kvien, Tore K; Landewé, Robert B; Leong, Amye L; Lyddiatt, Anne; March, Lyn; May, James; Montie, Pamela Lesley; Nikaï, Enkeleida; Richards, Pam; Voshaar, Marieke M J H; Smeets, Wilma; Strand, Vibeke; Tugwell, Peter; Gossec, Laure

    2014-05-01

    At a previous Outcome Measures in Rheumatology (OMERACT) meeting, participants reflected on the underlying methods of patient-reported outcome (PRO) instrument development. The participants requested proposals for more explicit instrument development protocols that would contribute to an enhanced version of the "Truth" statement in the OMERACT Filter, a widely used guide for outcome validation. In the present OMERACT session, we explored to what extent these new Filter 2.0 proposals were practicable, feasible, and already being applied. Following overview presentations, discussion groups critically reviewed the extent to which case studies of current OMERACT Working Groups complied with or negated the proposed PRO development framework, whether these observations had a more general application, and what issues remained to be resolved. Several aspects of PRO development were recognized as particularly important, and the need to directly involve patients at every stage of an iterative PRO development program was endorsed. This included recognition that patients contribute as partners in the research and not merely as subjects. Correct communication of concepts with the words used in questionnaires was central to their performance as measuring instruments, and ensuring this understanding crossed cultural and linguistic boundaries was important in international studies or comparisons. Participants recognized, endorsed, and were generally already putting into practice the principles of PRO development presented in the plenary session. Further work is needed on some existing instruments and on establishing widespread good practice for working in close collaboration with patients.

  9. 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

  10. Reported positive and negative outcomes associated with a self-practice/self-reflection cognitive-behavioural therapy exercise for CBT trainees.

    PubMed

    Spendelow, Jason S; Butler, Lisa J

    2016-09-01

    The aim of the current study was to identify outcomes of a self-practice/self-reflection (SP/SR) exercise for trainee clinical psychologists. Thirty-two trainees enrolled in their first year of a UK university doctoral clinical psychology training programme completed an online questionnaire following an eight-week exercise. Findings indicated an endorsement of many previously reported benefits of exercise participation, but also the identification of negative outcomes. Thematic analysis of qualitative data revealed that outcomes could be grouped into two main thematic domains (individual task outcomes and task organization issues) along with several subordinate themes. SP/SR is a useful tool in the development of trainee CBT therapist competences. There has been limited previous recognition of potential negative outcomes from this type of exercise. However, these can provide additional impetus for therapist skill development.

  11. A new internet-based tool for reporting and analysing patient-reported outcomes and the feasibility of repeated data collection from patients with myeloproliferative neoplasms.

    PubMed

    Brochmann, Nana; Zwisler, Ann-Dorthe; Kjerholt, Mette; Flachs, Esben Meulengracht; Hasselbalch, Hans Carl; Andersen, Christen Lykkegaard

    2016-04-01

    An Internet-based tool for reporting and analysing patient-reported outcomes (PROs) has been developed. The tool enables merging PROs with blood test results and allows for computation of treatment responses. Data may be visualized by graphical analysis and may be exported for downstream statistical processing. The aim of this study was to investigate, whether patients with myeloproliferative neoplasms (MPNs) were willing and able to use the tool and fill out questionnaires regularly. Participants were recruited from the outpatient clinic at the Department of Haematology, Roskilde University Hospital, Denmark. Validated questionnaires that were used were European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, Myeloproliferative Neoplasm Symptom Assessment Form, Brief Fatigue Inventory and Short Form 36 Health Survey. Questionnaires were filled out ≥ 6 months online or on paper according to participant preference. Regularity of questionnaire submission was investigated, and participant acceptance was evaluated by focus-group interviews. Of 135 invited patients, 118 (87 %) accepted participation. One hundred and seven participants (91 %) preferred to use the Internet-based tool. Of the 118 enrolled participants, 104 (88 %) submitted PROs regularly ≥ 6 months. The focus-group interviews revealed that the Internet-based tool was well accepted. The Internet-based approach and regular collection of PROs are well accepted with a high participation rate, persistency and adherence in a population of MPN patients. The plasticity of the platform allows for adaptation to patients with other medical conditions.

  12. Physical Education and Games in the Curriculum. ICHPER Questionnaire Report. Part 1.

    ERIC Educational Resources Information Center

    International Council on Health, Physical Education, and Recreation, Washington, DC.

    This report gives an overview of the organization, scope, and content of the physical education and games program provided for children and youth in the primary, intermediate, and secondary schools of 48 countries. The report is a synthesis of information received in response to questionnaires sent to key individuals in each country. Information…

  13. Relative validity of the Iowa Fluoride Study targeted nutrient semi-quantitative questionnaire and the block kids' food questionnaire for estimating beverage, calcium, and vitamin D intakes by children.

    PubMed

    Marshall, Teresa A; Eichenberger Gilmore, Julie M; Broffitt, Barbara; Stumbo, Phyllis J; Levy, Steven M

    2008-03-01

    Food frequency questionnaires are commonly developed and subsequently used to investigate relationships between dietary intake and disease outcomes; such tools should be validated in the population of interest. We investigated the relative validities of the Iowa Fluoride Study targeted nutrient semi-quantitative questionnaire and Block Kids' Food Questionnaire in assessing beverage, calcium, and vitamin D intakes using 3-day diaries for reference. Cross-sectional. Children who completed Iowa Fluoride Study nutrient questionnaire at age 9.0+/-0.7 years (n=223) and/or the Block Kids' Food Questionnaire at age 8.3+/-0.3 years (n=129) and 3-day diaries during similar time periods. Intakes of beverages, calcium, and vitamin D. Spearman correlation coefficients, weighted kappa statistics, and percentages of exact agreement were used to estimate relative validities. Correlations between milk intakes (r=0.572) reported on diaries and the Iowa Fluoride Study nutrient questionnaires were higher than correlations for 100% juice, juice drinks, soda pop, and water (r=0.252 to 0.379). Correlations between milk intakes (r=0.571) and 100% juice intakes (r=0.550) reported on diaries and Block Kids' Food Questionnaires were higher than correlations for other beverages (r=0.223 to 0.326). Correlations with diaries for calcium (r=0.462) and vitamin D (r=0.487) intakes reported on Iowa Fluoride Study nutrient questionnaires were similar to correlations with diaries for calcium (r=0.515) and vitamin D (r=0.512) reported on Block Kids' Food Questionnaires. Weighted kappa statistics were similar between the Iowa Fluoride Study nutrient questionnaires and the Block Kids' Food Questionnaires for milk, 100% juice, and vitamin D, but were higher on the Iowa Fluoride Study nutrient questionnaires than on the Block Kids' Food Questionnaires for calcium. Percentages of exact agreement were higher for calcium, but lower for vitamin D for intakes reported on the Iowa Fluoride Study nutrient

  14. Brief report: development of the inflammatory bowel disease family responsibility questionnaire.

    PubMed

    Greenley, Rachel Neff; Doughty, Alyssa; Stephens, Mike; Kugathasan, Subra

    2010-03-01

    To present psychometric data on youth and parent versions of the Inflammatory Bowel Disease-Family Responsibility Questionnaire (IBD-FRQ), a measure of family involvement in IBD management. Fifty-eight adolescents with inflammatory bowel disease (IBD), along with 55 mothers and 26 fathers completed the IBD-FRQ, a demographics questionnaire, and a measure of family involvement in decision making in non-IBD domains. Medical information was obtained via chart review. Support for the internal consistency of the IBD-FRQ was obtained. Evidence of validity was documented via moderate to high intercorrelations among reporters. Youth involvement increased with youth age, while maternal and paternal involvement decreased with youth age. Across all reporters, maternal involvement was higher than paternal involvement. Preliminary analyses offer support for the measure's reliability and validity. The measure shows promise as a means of assessing family involvement in IBD condition management; however, further validation studies are needed.

  15. The Discrepancy between Performance-Based Measures and Questionnaires when Assessing Clinical Outcomes and Quality of Life in Pediatric Patients with Neurological Disorders.

    PubMed

    Coutinho, V; Câmara-Costa, H; Kemlin, I; Billette de Villemeur, T; Rodriguez, D; Dellatolas, G

    2017-01-01

    In clinical outcome assessment, the relation between performance-based measures and questionnaire ratings of the same domain is weak, but correlations between questionnaires proposed for the evaluation of different domains are strong. The present study aims to illustrate these phenomena in a group of patients with neurofibromatosis type 1 (NF1) and to propose an explanatory hypothesis. A single neuropsychologist interviewed the parents about the child's situation and current difficulties and then assessed this parental view as overall positive or overall negative. The same assessor then administered the Wechsler Intelligence Scales and neuropsychological tests to 78 children and adolescents with NF1 (5-18 years). Parents then completed the Child Behavioral Checklist (CBCL), the Conners' Parent Rating Scale, the Behavior Rating Inventory of Executive Function (BRIEF), as well as questionnaires assessing quality of life, impact of the medical disorder, and their own difficulties. All questionnaires were inter-correlated (r = 0.29 - 0.84) and associated with the overall positive or negative parental view of the child's progress (effect size = 0.41-1.46). Conversely, questionnaires were weakly or not significantly related to intelligence, cognitive measures, or clinical severity. In conclusion, the parental view of the child's progress was related to the answers to questionnaires assessing quality of life or strengths and difficulties of patients with a neurological disorder. This factor should be assessed independently and taken into account when assessing clinical outcome.

  16. Effect of Intensive Blood-Pressure Treatment on Patient-Reported Outcomes.

    PubMed

    Berlowitz, Dan R; Foy, Capri G; Kazis, Lewis E; Bolin, Linda P; Conroy, Molly B; Fitzpatrick, Peter; Gure, Tanya R; Kimmel, Paul L; Kirchner, Kent; Morisky, Donald E; Newman, Jill; Olney, Christine; Oparil, Suzanne; Pajewski, Nicholas M; Powell, James; Ramsey, Thomas; Simmons, Debra L; Snyder, Joni; Supiano, Mark A; Weiner, Daniel E; Whittle, Jeff

    2017-08-24

    The previously published results of the Systolic Blood Pressure Intervention Trial showed that among participants with hypertension and an increased cardiovascular risk, but without diabetes, the rates of cardiovascular events were lower among those who were assigned to a target systolic blood pressure of less than 120 mm Hg (intensive treatment) than among those who were assigned to a target of less than 140 mm Hg (standard treatment). Whether such intensive treatment affected patient-reported outcomes was uncertain; those results from the trial are reported here. We randomly assigned 9361 participants with hypertension to a systolic blood-pressure target of less than 120 mm Hg or a target of less than 140 mm Hg. Patient-reported outcome measures included the scores on the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the Veterans RAND 12-Item Health Survey, the Patient Health Questionnaire 9-item depression scale (PHQ-9), patient-reported satisfaction with their blood-pressure care and blood-pressure medications, and adherence to blood-pressure medications. We compared the scores in the intensive-treatment group with those in the standard-treatment group among all participants and among participants stratified according to physical and cognitive function. Participants who received intensive treatment received an average of one additional antihypertensive medication, and the systolic blood pressure was 14.8 mm Hg (95% confidence interval, 14.3 to 15.4) lower in the group that received intensive treatment than in the group that received standard treatment. Mean PCS, MCS, and PHQ-9 scores were relatively stable over a median of 3 years of follow-up, with no significant differences between the two treatment groups. No significant differences between the treatment groups were noted when participants were stratified according to baseline measures of physical or cognitive function. Satisfaction with blood-pressure care was high in both treatment

  17. Cross-cultural adaptation, validation, and reliability of the Michigan Hand Outcomes Questionnaire among Persian population.

    PubMed

    Ebrahimzadeh, Mohammad H; Birjandinejad, Ali; Kachooei, Amir Reza

    2015-01-01

    We aimed to validate a cross-culturally adapted version of the Persian Michigan Hand Outcomes Questionnaire (MHOQ). We followed the Beaton's guideline to translate the questionnaire to Persian. We administered the final version to 223 patients among which 79 patients returned 3 days later to respond to the Persian MHOQ for the second time. In the first visit, respondents also filled the Disabilities of the Arm Shoulder and Hand (DASH) and rated the pain based on the Visual Analogue Scale (VAS). Cronbach's alpha for the total MHOQ was 0.79 which showed good internal consistency. Intraclass correlation coefficient (ICC) for the total MHOQ was 0.84 which demonstrated good reliability between test and retest. The absolute correlation coefficient between total MHOQ and the DASH was as high as 0.74. Persian version of the MHOQ proved to be a reliable and valid instrument to be implemented among Persian population with the hand and wrist disorders.

  18. 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

  19. 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

    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.

  20. Factor Analysis of the Modified Sexual Adjustment Questionnaire-Male

    PubMed Central

    Wilmoth, Margaret C.; Hanlon, Alexandra L.; Ng, Lit Soo; Bruner, Debra W.

    2015-01-01

    Background and Purpose The Sexual Adjustment Questionnaire (SAQ) is used in National Cancer Institute–sponsored clinical trials as an outcome measure for sexual functioning. The tool was revised to meet the needs for a clinically useful, theory-based outcome measure for use in both research and clinical settings. This report describes the modifications and validity testing of the modified Sexual Adjustment Questionnaire-Male (mSAQ-Male). Methods This secondary analysis of data from a large Radiation Therapy Oncology Group trial employed principal axis factor analytic techniques in estimating validity of the revised tool. The sample size was 686; most subjects were White, older than the age 60 years, and with a high school education and a Karnofsky performance scale (KPS) score of greater than 90. Results A 16-item, 3-factor solution resulted from the factor analysis. The mSAQ-Male was also found to be sensitive to changes in physical sexual functioning as measured by the KPS. Conclusion The mSAQ-Male is a valid self-report measure of sexuality that can be used clinically to detect changes in male sexual functioning. PMID:25255676

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

    ERIC Educational Resources Information Center

    US Department of Health and Human Services, 2008

    2008-01-01

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

  2. 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…

  3. Development and validation of a patient-reported outcome measure for stroke patients.

    PubMed

    Luo, Yanhong; Yang, Jie; Zhang, Yanbo

    2015-05-08

    Family support and patient satisfaction with treatment are crucial for aiding in the recovery from stroke. However, current validated stroke-specific questionnaires may not adequately capture the impact of these two variables on patients undergoing clinical trials of new drugs. Therefore, the aim of this study was to develop and evaluate a new stroke patient-reported outcome measure (Stroke-PROM) instrument for capturing more comprehensive effects of stroke on patients participating in clinical trials of new drugs. A conceptual framework and a pool of items for the preliminary Stroke-PROM were generated by consulting the relevant literature and other questionnaires created in China and other countries, and interviewing 20 patients and 4 experts to ensure that all germane parameters were included. During the first item-selection phase, classical test theory and item response theory were applied to an initial scale completed by 133 patients with stroke. During the item-revaluation phase, classical test theory and item response theory were used again, this time with 475 patients with stroke and 104 healthy participants. During the scale assessment phase, confirmatory factor analysis was applied to the final scale of the Stroke-PROM using the same study population as in the second item-selection phase. Reliability, validity, responsiveness and feasibility of the final scale were tested. The final scale of Stroke-PROM contained 46 items describing four domains (physiology, psychology, society and treatment). These four domains were subdivided into 10 subdomains. Cronbach's α coefficients for the four domains ranged from 0.861 to 0.908. Confirmatory factor analysis supported the validity of the final scale, and the model fit index satisfied the criterion. Differences in the Stroke-PROM mean scores were significant between patients with stroke and healthy participants in nine subdomains (P < 0.001), indicating that the scale showed good responsiveness. The Stroke

  4. Patient-Reported Esthetic and Functional Outcomes of Primary Total Laparoscopic Intestinal Vaginoplasty in Transgender Women With Penoscrotal Hypoplasia.

    PubMed

    Bouman, Mark-Bram; van der Sluis, Wouter B; van Woudenberg Hamstra, Leonora E; Buncamper, Marlon E; Kreukels, Baudewijntje P C; Meijerink, Wilhelmus J H J; Mullender, Margriet G

    2016-09-01

    Puberty-suppressing hormonal treatment may result in penoscrotal hypoplasia in transgender women, making standard penile inversion vaginoplasty not feasible. For these patients, intestinal vaginoplasty is a surgical alternative, but knowledge on patient-reported postoperative outcomes and quality of life is lacking. To assess patient-reported functional and esthetic outcomes, quality of life, satisfaction, and sexual well-being after primary total laparoscopic intestinal vaginoplasty in transgender women. A survey study was performed on transgender women who underwent primary total laparoscopic intestinal vaginoplasty with at least 1 year of clinical follow-up. Thirty-one transgender women completed the questionnaires (median age at time of surgery = 19.1 years, range = 18.3-45.0) after a median clinical follow-up of 2.2 years (range = 0.8-7.5). Consenting women were asked to complete a combined questionnaire of the Subjective Happiness Scale, the Satisfaction With Life Scale, Cantril's Ladder of Life Scale, the Female Sexual Function Index, the Female Genital Self-Imaging Scale, the Amsterdam Hyperactive Pelvic Floor Scale-Women, and a questionnaire addressing postoperative satisfaction. Patient-reported functional and esthetic outcomes and postoperative quality of life. Patients graded their life satisfaction a median of 8.0 (range = 4.0-10.0) on Cantril's Ladder of Life Scale. Patients scored a mean total score of 27.7 ± 5.8 on the Satisfaction With Life Scale, which indicated high satisfaction with life, and a mean total score of 5.6 ± 1.4 on the Subjective Happiness Scale. Functionality was graded a median score of 8.0 of 10 (range = 1.0-10.0) and esthetics a score of 8.0 out of 10 (range = 3.0-10.0). The mean Female Sexual Function Index total score of sexually active transgender women was 26.0 ± 6.8. This group of relatively young transgender women reported satisfactory functional and esthetic results of the neovagina and a good quality of life

  5. Evaluation of Relationships Between Reported Resilience and Soldier Outcomes. Report #1: Negative Outcomes (Suicide, Drug Use, & Violent Crimes)

    DTIC Science & Technology

    2011-02-28

    100 -.039 -.100 .024 .616 1 7. Bad Coping -. 048 .057 -.108 .043 .174 .092 1 8 . Catastrophizing -.012 -.095 -.096...PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) TKC Global Solutions LLC, 3201 C St STE 400F, Anchorage, AK 99503-3967 8 . PERFORMING ORGANIZATION... 8 -98) Prescribed by ANSI Std. Z39.18 Evaluation of Relationships Between Reported Resilience and Soldier Outcomes Report #1: Negative Outcomes

  6. Towards Usable E-Health. A Systematic Review of Usability Questionnaires.

    PubMed

    Sousa, Vanessa E C; Dunn Lopez, Karen

    2017-05-10

    The use of e-health can lead to several positive outcomes. However, the potential for e-health to improve healthcare is partially dependent on its ease of use. In order to determine the usability for any technology, rigorously developed and appropriate measures must be chosen. To identify psychometrically tested questionnaires that measure usability of e-health tools, and to appraise their generalizability, attributes coverage, and quality. We conducted a systematic review of studies that measured usability of e-health tools using four databases (Scopus, PubMed, CINAHL, and HAPI). Non-primary research, studies that did not report measures, studies with children or people with cognitive limitations, and studies about assistive devices or medical equipment were systematically excluded. Two authors independently extracted information including: questionnaire name, number of questions, scoring method, item generation, and psychometrics using a data extraction tool with pre-established categories and a quality appraisal scoring table. Using a broad search strategy, 5,558 potentially relevant papers were identified. After removing duplicates and applying exclusion criteria, 35 articles remained that used 15 unique questionnaires. From the 15 questionnaires, only 5 were general enough to be used across studies. Usability attributes covered by the questionnaires were: learnability (15), efficiency (12), and satisfaction (11). Memorability (1) was the least covered attribute. Quality appraisal showed that face/content (14) and construct (7) validity were the most frequent types of validity assessed. All questionnaires reported reliability measurement. Some questionnaires scored low in the quality appraisal for the following reasons: limited validity testing (7), small sample size (3), no reporting of user centeredness (9) or feasibility estimates of time, effort, and expense (7). Existing questionnaires provide a foundation for research on e-health usability. However

  7. Patient-reported outcomes of catheter-based accelerated partial breast brachytherapy and whole breast irradiation, a single institution experience.

    PubMed

    Jethwa, Krishan R; Kahila, Mohamed M; Mara, Kristin C; Harmsen, William S; Routman, David M; Pumper, Geralyn M; Corbin, Kimberly S; Sloan, Jeff A; Ruddy, Kathryn J; Hieken, Tina J; Park, Sean S; Mutter, Robert W

    2018-05-01

    Accelerated partial breast irradiation (APBI) and whole breast irradiation (WBI) are treatment options for early-stage breast cancer. The purpose of this study was to compare patient-reported-outcomes (PRO) between patients receiving multi-channel intra-cavitary brachytherapy APBI or WBI. Between 2012 and 2015, 131 patients with ductal carcinoma in situ (DCIS) or early stage invasive breast cancer were treated with adjuvant APBI (64) or WBI (67) and participated in a PRO questionnaire. The linear analog scale assessment (LASA), harvard breast cosmesis scale (HBCS), PRO-common terminology criteria for adverse events- PRO (PRO-CTCAE), and breast cancer treatment outcome scale (BCTOS) were used to assess quality of life (QoL), pain, fatigue, aesthetic and functional status, and breast cosmesis. Comparisons of PROs were performed using t-tests, Wilcoxon rank-sum, Chi square, Fisher exact test, and regression methods. Median follow-up from completion of radiotherapy and questionnaire completion was 13.3 months. There was no significant difference in QoL, pain, or fatigue severity, as assessed by the LASA, between treatment groups (p > 0.05). No factors were found to be predictive of overall QoL on regression analysis. BCTOS health-related QoL scores were similar between treatment groups (p = 0.52).The majority of APBI and WBI patients reported excellent/good breast cosmesis, 88.5% versus 93.7% (p = 0.37). Skin color change (p = 0.011) and breast elevation (p = 0.01) relative to baseline were more common in the group receiving WBI. APBI and WBI were both associated with favorable patient-reported outcomes in early follow-up. APBI resulted in a lesser degree of patient-reported skin color change and breast elevation relative to baseline.

  8. 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.

  9. Development and validation of a patient-reported questionnaire assessing systemic therapy induced diarrhea in oncology patients.

    PubMed

    Lui, Michelle; Gallo-Hershberg, Daniela; DeAngelis, Carlo

    2017-12-22

    Systemic therapy-induced diarrhea (STID) is a common side effect experienced by more than half of cancer patients. Despite STID-associated complications and poorer quality of life (QoL), no validated assessment tools exist to accurately assess STID occurrence and severity to guide clinical management. Therefore, we developed and validated a patient-reported questionnaire (STIDAT). The STIDAT was developed using the FDA iterative process for patient-reported outcomes. A literature search uncovered potential items and questions for questionnaire construction used by oncology clinicians to develop questions for the preliminary instrument. The instrument was evaluated on its face validity and content validity by patient interviews. Repetitive, similar and different themes uncovered from patient interviews were implemented to revise the instrument to the version used for validation. Patients starting high-risk STID treatments were monitored using the STIDAT, bowel diaries and EORTC QLQ-C30. The STIDAT was evaluated for construct validity using exploratory factor analysis (EFA) using minimal residual method with Promax rotation, reliability and consistency. A weighted scoring system was developed and a receiver-operating characteristic (ROC) curve evaluated the tool's ability to detect STID occurrence. Median scores and variability were analysed to determine how well it differentiates between diarrhea severities. A post-hoc analysis determined how diarrhea severity impacted QoL of cancer patients. Patients defined diarrhea based on presence of watery stool. The STIDAT assessed patient's perception of having diarrhea, daily number of bowel movements, daily number of diarrhea episodes, antidiarrheal medication use, the presence of urgency, abdominal pain, abdominal spasms or fecal incontinence, patient's perception of diarrhea severity, and QoL. These dimensions were sorted into four clusters using EFA - patient's perception of diarrhea, frequency of diarrhea, fecal

  10. 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…

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

    PubMed Central

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

    2016-01-01

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

  12. Validity of questionnaire self‐reports on computer, mouse and keyboard usage during a four‐week period

    PubMed Central

    Mikkelsen, Sigurd; Vilstrup, Imogen; Lassen, Christina Funch; Kryger, Ann Isabel; Thomsen, Jane Frølund; Andersen, Johan Hviid

    2007-01-01

    Objective To examine the validity and potential biases in self‐reports of computer, mouse and keyboard usage times, compared with objective recordings. Methods A study population of 1211 people was asked in a questionnaire to estimate the average time they had worked with computer, mouse and keyboard during the past four working weeks. During the same period, a software program recorded these activities objectively. The study was part of a one‐year follow‐up study from 2000–1 of musculoskeletal outcomes among Danish computer workers. Results Self‐reports on computer, mouse and keyboard usage times were positively associated with objectively measured activity, but the validity was low. Self‐reports explained only between a quarter and a third of the variance of objectively measured activity, and were even lower for one measure (keyboard time). Self‐reports overestimated usage times. Overestimation was large at low levels and declined with increasing levels of objectively measured activity. Mouse usage time proportion was an exception with a near 1:1 relation. Variability in objectively measured activity, arm pain, gender and age influenced self‐reports in a systematic way, but the effects were modest and sometimes in different directions. Conclusion Self‐reported durations of computer activities are positively associated with objective measures but they are quite inaccurate. Studies using self‐reports to establish relations between computer work times and musculoskeletal pain could be biased and lead to falsely increased or decreased risk estimates. PMID:17387136

  13. Validity of questionnaire self-reports on computer, mouse and keyboard usage during a four-week period.

    PubMed

    Mikkelsen, Sigurd; Vilstrup, Imogen; Lassen, Christina Funch; Kryger, Ann Isabel; Thomsen, Jane Frølund; Andersen, Johan Hviid

    2007-08-01

    To examine the validity and potential biases in self-reports of computer, mouse and keyboard usage times, compared with objective recordings. A study population of 1211 people was asked in a questionnaire to estimate the average time they had worked with computer, mouse and keyboard during the past four working weeks. During the same period, a software program recorded these activities objectively. The study was part of a one-year follow-up study from 2000-1 of musculoskeletal outcomes among Danish computer workers. Self-reports on computer, mouse and keyboard usage times were positively associated with objectively measured activity, but the validity was low. Self-reports explained only between a quarter and a third of the variance of objectively measured activity, and were even lower for one measure (keyboard time). Self-reports overestimated usage times. Overestimation was large at low levels and declined with increasing levels of objectively measured activity. Mouse usage time proportion was an exception with a near 1:1 relation. Variability in objectively measured activity, arm pain, gender and age influenced self-reports in a systematic way, but the effects were modest and sometimes in different directions. Self-reported durations of computer activities are positively associated with objective measures but they are quite inaccurate. Studies using self-reports to establish relations between computer work times and musculoskeletal pain could be biased and lead to falsely increased or decreased risk estimates.

  14. Application of Rasch analysis to the parent adherence report questionnaire in juvenile idiopathic arthritis.

    PubMed

    Toupin April, Karine; Higgins, Johanne; Ehrmann Feldman, Debbie

    2016-07-28

    Adherence to treatment in children with juvenile idiopathic arthritis (JIA) is associated with better outcomes. Assessing patient adherence in JIA, as well as attitudes and beliefs about prescribed treatments, is important for the clinician in order to optimize patient management. The objective of the current study was to evaluate the psychometric properties of the Parent (proxy-report) Adherence Report Questionnaires (PARQ), which assesses beliefs and behaviors related to adherence to treatments prescribed for JIA. A Rasch analysis was conducted on data collected with parents of children with JIA from two studies in which the PARQ was used as a measure of adherence. The PARQ showed preliminary evidence of multidimensionality with two factors, accounting for 38 % and 27 % of the variance respectively. The PARQ in its original version does not adhere to expectations of the Rasch model. A transformed version of the PARQ obtained by deletion of the general adherence scale and modification of visual analog scales into 5-point likert scales improved fit to the model and showed preliminary evidence of unidimensionality. The PARQ was transformed based on the results of the Rasch analysis. The transformed version of the PARQ shows preliminary evidence of unidimensionality and may allow computation of a total score, although further testing is needed to verify these findings.

  15. 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

  16. Using patient-reported outcomes in schizophrenia: the Scottish Schizophrenia Outcomes Study.

    PubMed

    Hunter, Robert; Cameron, Rosie; Norrie, John

    2009-02-01

    The primary aim of the Scottish Schizophrenia Outcomes Study (SSOS) was to assess the feasibility and utility of routinely collecting outcome data in everyday clinical settings. Data were collected over three years in the Scottish National Health Service (NHS). There were two secondary aims of SSOS: first, to compare data from patient-rated, objective, and clinician-rated outcomes, and second, to describe trends in outcome data and service use across Scotland over the three years of the study (2002-2005). This study used a naturalistic, longitudinal, observational cohort design. A representative sample of 1,015 persons with ICD-10 F20-F29 diagnoses (schizophrenia, schizotypal disorders, or delusional disorders) was assessed annually using the clinician-rated measure, the Health of the Nation Outcome Scale (HoNOS), and the patient-reported assessment, the Avon Mental Health Measure (Avon). Objective outcomes data and information on services and interventions were collected. Data were analyzed with regression modeling. Of the 1,015 persons recruited, 78% of the cohort (N=789) completed the study. Over the study period, significant decreases were seen in the number of hospitalizations, incidence of attempted suicide and self-harm, and civil detentions. Avon scores indicated significant improvement on all subscales (behavior, social, access, and mental health) and on the total score. However, HoNOS scores on the behavior and symptom subscales did not change, scores on the impairment subscale increased significantly (indicating increased levels of impairment), and scores on the social subscale decreased significantly (indicating improved social functioning). This study has demonstrated that it is feasible within the Scottish NHS to routinely collect meaningful outcomes data in schizophrenia. Patient-reported assessments were also successfully collected and used in care plans. This model shows that it is possible to incorporate patient-reported assessments into routine

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

    PubMed

    Pilgrim, A L; Baylis, D; Jameson, K A; Cooper, C; Sayer, A A; Robinson, S M; Roberts, H C

    2016-01-01

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

  18. Preliminary validation of the Review of Musculoskeletal System (ROMS) questionnaire.

    PubMed

    Bershadsky, Boris; Kane, Robert L; Wuerz, Thomas; Jones, Morgan; Brighton, Brian; Stitzlein, Russell; Parker, Richard; Iannotti, Joseph P

    2015-04-01

    Measurement of clinical outcomes is necessary to define best practice. It requires a validated tool that can be easily applied as part of clinical practice. We present the preliminary validation of a brief self-reported Review of Musculoskeletal System (ROMS) questionnaire that captures functional limitations due to musculoskeletal problems and other medical and emotional conditions. Data were derived from a clinical outcomes database (Orthopaedic Minimal Data Set [OrthoMiDaS]) that combines patient-reported data collected as part of routine care and secondary data extracted from electronic medical records. The study utilized 82,873 encounters collected from 24,116 consecutive patients with problems in the upper and lower extremities. In addition to the ROMS, the study used version 2 of the Short Form-12 (SF-12v2), the Penn Shoulder Score (PSS), the Hip disability and Osteoarthritis Outcome Score (HOOS), and the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaires. Fifteen cross-sectional samples were used to evaluate the floor and ceiling effects as well as the construct and content validity. Five longitudinal cohorts were used to measure test-retest reliability and responsiveness. Standard statistical tests were applied. The floor and ceiling effects of the ROMS questionnaire in patients with shoulder, hip, and knee problems ranged from 1.3% to 8.5%. Construct-validity tests confirmed convergent and divergent validity of the ROMS. The tests also justified its additional value when the ROMS was used with joint-specific tools. When measuring test-retest reliability of the ROMS scales, intraclass correlation ranged from 0.80 to 0.90 at approximately one week and from 0.71 to 0.87 at approximately four weeks. Responsiveness of the ROMS was greater than that of the SF-12 and less than that of the joint-specific questionnaires. The ROMS is compatible with routine clinical process and has good psychometric properties in patients with shoulder, hip, and

  19. Psychometric validation of the PROQOL-HIV questionnaire, a new health-related quality of life instrument-specific to HIV disease.

    PubMed

    Duracinsky, Martin; Lalanne, Christophe; Le Coeur, Sophie; Herrmann, Susan; Berzins, Baiba; Armstrong, Andrew Richard; Lau, Joseph Tak Fai; Fournier, Isabelle; Chassany, Olivier

    2012-04-15

    This study reports the psychometric validation of a new HIV/AIDS-specific health-related quality of life (HRQL) questionnaire, the Patient Reported Outcomes Quality of Life-HIV. The instrument was developed simultaneously across Europe, North and South America, Africa, Asia, and Australia to assess multidimensional quality of life impairments in the era of highly active antiretroviral therapy. A cross-sectional study was performed in 8 countries. The pilot 70-item questionnaire was co-administered with the HIV symptoms index, the EQ-5D and Medical Outcomes Study-HIV questionnaires. Demographic and biomedical data were collected. After item analysis and reduction, convergent discriminant concurrent validity and known-group validity were examined. Internal consistency and reliability scores were assessed using Cronbach alpha and intraclass correlation. The final sample of 791 patients was composed of 64% males (median age: 41 years, HIV diagnosis = 5 years), 13.8% were treatment naive. Item reduction yielded a 43-item form surveying 8 dimensions and 1 global health item that showed good convergent and discriminant validity and reliability (98% scaling success; Cronbach alphas 0.77-0.89). Correlations with EQ-5D and Medical Outcomes Study-HIV complied with concurrent validity expectations; likewise, correlations against the number of self-reported symptoms and depression showed good support for criterion validity. A test-retest study on French patients (n = 34) showed temporal stability (intraclass correlation coefficient = 0.86). Significant and meaningful differences of HRQL scores between countries were found. The Patient Reported Outcomes Quality of Life-HIV questionnaire is a valid and reliable instrument for assessing HRQL specific to HIV disease in different cultures and healthcare systems.

  20. Patient-Reported Allergies Predict Worse Outcomes After Hip and Knee Arthroplasty: Results From a Prospective Cohort Study.

    PubMed

    Otero, Jesse E; Graves, Christopher M; Gao, Yubo; Olson, Tyler S; Dickinson, Christopher C; Chalus, Rhonda J; Vittetoe, David A; Goetz, Devon D; Callaghan, John J

    2016-12-01

    Retrospective analyses have demonstrated correlation between patient-reported allergies and negative outcomes after total joint arthroplasty. We sought to validate these observations in a prospective cohort. One hundred forty-four patients undergoing total hip arthroplasty and 302 patients undergoing total knee arthroplasty were prospectively enrolled. Preoperatively, patients listed their allergies and completed the Medical Outcomes Study Short Form 36 (SF-36) and the Charlson Comorbidity Index (CCI) Questionnaire. At a mean of 17 months (range 12-25 months) postoperatively, SF-36, CCI, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) were obtained by telephone survey. Regression analysis was used to determine the strength of correlation between patient age, comorbidity burden, and number of allergies and outcome measurements. In 446 patients, 273 reported at least 1 allergy. The number of allergies reported ranged from 0 to 33. Penicillin or its derivative was the most frequently reported allergy followed by sulfa, environmental allergen, and narcotic pain medication. Patients reporting at least 1 allergy had a significantly lower postoperative SF-36 Physical Component Score compared to those reporting no allergies (51.3 vs 49.4, P = .01). The SF-36 postoperative Mental Component Score was no different between groups. Multivariate regression analysis showed that age and patient reported allergies, but not comorbidities, were independently associated with worse postoperative SF-36 Physical Component Summary (PCS) and WOMAC score. Patients with allergies experienced the same improvement in SF-36 PCS as those without an allergy. Comorbidities did not correlate with patient-reported function postoperatively. Patients who report allergies have lower postoperative outcome scores but may experience the same increment in improvement after total joint arthroplasty. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. Quality of life and urolithiasis: the patient - reported outcomes measurement information system (PROMIS).

    PubMed

    Patel, Nishant; Brown, Robert D; Sarkissian, Carl; De, Shubha; Monga, Manoj

    2017-01-01

    With a high rate of recurrence, urolithiasis is a chronic disease that impacts quality of life. The Patient Reported Outcomes Measurement Information System is an NIH validated questionnaire to assess patient quality of life. We evaluated the impact of urolithiasis on quality of life using the NIH-sponsored PROMIS-43 questionnaire. Patients reporting to the kidney stone clinic were interviewed to collect information on stone history and demographic information and were asked to complete the PROMIS-43 questionnaire. Quality of life scores were analyzed using gender and age matched groups for the general US population. Statistical comparisons were made based on demographic information and patient stone history. Statistical significance was P<0.05. 103 patients completed the survey. 36% of respondents were male, the average age of the group was 52 years old, with 58% primary income earners, and 35% primary caregivers. 7% had never passed a stone or had a procedure while 17% passed 10 or more stones in their lifetime. Overall, pain and physical function were worse in patients with urolithiasis. Primary income earners had better quality of life while primary caregivers and those with other chronic medical conditions were worse. Patients on dietary and medical therapy had better quality of life scores. Urolithiasis patients subjectively have worse pain and physical function than the general population. The impact of pain on quality of life was greatest in those patients who had more stone episodes, underscoring the importance of preventive measures. Stone prevention measures improve quality of life. Copyright® by the International Brazilian Journal of Urology.

  2. Patient-Reported Outcome Instruments for Surgical and Traumatic Scars: A Systematic Review of their Development, Content, and Psychometric Validation.

    PubMed

    Mundy, Lily R; Miller, H Catherine; Klassen, Anne F; Cano, Stefan J; Pusic, Andrea L

    2016-10-01

    Patient-reported outcomes (PROs) are of growing importance in research and clinical care and may be used as primary outcomes or as compliments to traditional surgical outcomes. In assessing the impact of surgical and traumatic scars, PROs are often the most meaningful. To assess outcomes from the patient perspective, rigorously developed and validated PRO instruments are essential. The authors conducted a systematic literature review to identify PRO instruments developed and/or validated for patients with surgical and/or non-burn traumatic scars. Identified instruments were assessed for content, development process, and validation under recommended guidelines for PRO instrument development. The systematic review identified 6534 articles. After review, we identified four PRO instruments meeting inclusion criteria: patient and observer scar assessment scale (POSAS), bock quality of life questionnaire for patients with keloid and hypertrophic scarring (Bock), patient scar assessment questionnaire (PSAQ), and patient-reported impact of scars measure (PRISM). Common concepts measured were symptoms and psychosocial well-being. Only PSAQ had a dedicated appearance domain. Qualitative data were used to inform content for the PSAQ and PRISM, and a modern psychometric approach (Rasch Measurement Theory) was used to develop PRISM and to test POSAS. Overall, PRISM demonstrated the most rigorous design and validation process, however, was limited by the lack of a dedicated appearance domain. PRO instruments to evaluate outcomes in scars exist but vary in terms of concepts measured and psychometric soundness. This review discusses the strengths and weaknesses of existing instruments, highlighting the need for future scar-focused PRO instrument development. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to Table of Contents or the online Instructions to Authors www

  3. Pilot Test of the Online Public Access Catalog Project's User and Nonuser Questionnaires. Final Report.

    ERIC Educational Resources Information Center

    Markey, Karen

    This report describes the pilot data collections and post-questionnaire interview activities of the Council on Library Resources (CLR)/Online Computer Library Center (OCLC) Online Public Access Project. The background of the project is briefly described, the purpose and adminstration of the post-questionnaire interviews are outlined, and pilot…

  4. The relationship between child- and parent-reported shared decision making and child-, parent-, and clinician-reported treatment outcome in routinely collected child mental health services data.

    PubMed

    Edbrooke-Childs, Julian; Jacob, Jenna; Argent, Rachel; Patalay, Praveetha; Deighton, Jessica; Wolpert, Miranda

    2016-04-01

    Shared decision making (SDM) between service users and providers is increasingly being suggested as a key component of good healthcare. The aim of this research was to explore whether child- and parent-reported experience of SDM was associated with child- and parent-reported improvement in psychosocial difficulties and clinician-reported functioning at the end of treatment in child and adolescent mental health services (CAMHS). The sample comprised N = 177 children (62% female; 31% aged 6-12 and 69% aged 13-18) with a variety of mental health problems from 17 services where routinely collected data consisted of presenting problems at outset, child- and parent-reported change in symptoms between Time 1 and Time 2 (Strengths and Difficulties Questionnaire; SDQ), clinician-reported change in functioning between Time 1 and Time 2 (Children's Global Assessment Scale; CGAS), and experience of SDM at Time 2 (as measured by responses to the Experience of Service Questionnaire; ESQ). Analysis revealed that both child- and parent-reported experience of SDM were associated with higher levels of child- and parent-reported improvement in psychosocial difficulties. However, child-reported experience of SDM was only associated with higher levels of child-reported improvement when their parents also reported higher levels of SDM. In CAMHS, involving both children and parents in decision making may contribute to enhanced treatment outcomes. © The Author(s) 2015.

  5. Forecasting COPD hospitalization in the clinic: optimizing the chronic respiratory questionnaire

    PubMed Central

    Abascal-Bolado, Beatriz; Novotny, Paul J; Sloan, Jeff A; Karpman, Craig; Dulohery, Megan M; Benzo, Roberto P

    2015-01-01

    Purpose Forecasting hospitalization in patients with COPD has gained significant interest in the field of COPD care. There is a need to find simple tools that can help clinicians to stratify the risk of hospitalization in these patients at the time of care. The perception of quality of life has been reported to be independently associated with hospitalizations, but questionnaires are impractical for daily clinical use. Individual questions from valid questionnaires can have robust predictive abilities, as has been suggested in previous reports, as a way to use patient-reported outcomes to forecast important events like hospitalizations in COPD. Our primary aim was to assess the predictive value of individual questions from the Chronic Respiratory Questionnaire Self-Assessment Survey (CRQ-SAS) on the risk of hospitalization and to develop a clinically relevant and simple algorithm that clinicians can use in routine practice to identify patients with an increased risk of hospitalization. Patients and methods A total of 493 patients with COPD prospectively recruited from an outpatient pulmonary clinic completed the CRQ-SAS, demographic information, pulmonary function testing, and clinical outcomes. The cohort had a mean age of 70 years, was 54% male, with forced expiratory volume in 1 second percentage predicted 42.8±16.7, and modified Medical Research Council dyspnea scale score of 2±1.13. Results Our analysis validated the original CRQ-SAS domains. Importantly, recursive partitioning analysis identified three CRQ-SAS items regarding fear or panic of breathlessness, dyspnea with basic activities of daily living, and depressive symptoms that were highly predictive of hospitalization. We propose a robust (area under the curve =0.70) but short and easy algorithm for daily clinical care to forecast hospitalizations in patients with COPD. Conclusion We identified three themes – fear of breathlessness, dyspnea with basic activities of daily living, and depressive

  6. Forecasting COPD hospitalization in the clinic: optimizing the chronic respiratory questionnaire.

    PubMed

    Abascal-Bolado, Beatriz; Novotny, Paul J; Sloan, Jeff A; Karpman, Craig; Dulohery, Megan M; Benzo, Roberto P

    2015-01-01

    Forecasting hospitalization in patients with COPD has gained significant interest in the field of COPD care. There is a need to find simple tools that can help clinicians to stratify the risk of hospitalization in these patients at the time of care. The perception of quality of life has been reported to be independently associated with hospitalizations, but questionnaires are impractical for daily clinical use. Individual questions from valid questionnaires can have robust predictive abilities, as has been suggested in previous reports, as a way to use patient-reported outcomes to forecast important events like hospitalizations in COPD. Our primary aim was to assess the predictive value of individual questions from the Chronic Respiratory Questionnaire Self-Assessment Survey (CRQ-SAS) on the risk of hospitalization and to develop a clinically relevant and simple algorithm that clinicians can use in routine practice to identify patients with an increased risk of hospitalization. A total of 493 patients with COPD prospectively recruited from an outpatient pulmonary clinic completed the CRQ-SAS, demographic information, pulmonary function testing, and clinical outcomes. The cohort had a mean age of 70 years, was 54% male, with forced expiratory volume in 1 second percentage predicted 42.8±16.7, and modified Medical Research Council dyspnea scale score of 2±1.13. Our analysis validated the original CRQ-SAS domains. Importantly, recursive partitioning analysis identified three CRQ-SAS items regarding fear or panic of breathlessness, dyspnea with basic activities of daily living, and depressive symptoms that were highly predictive of hospitalization. We propose a robust (area under the curve =0.70) but short and easy algorithm for daily clinical care to forecast hospitalizations in patients with COPD. We identified three themes - fear of breathlessness, dyspnea with basic activities of daily living, and depressive symptoms - as important patient-reported outcomes to

  7. Measuring Physical Activity in Pregnancy Using Questionnaires: A Meta-Analysis

    PubMed

    Schuster, Snježana; Šklempe Kokić, Iva; Sindik, Joško

    2016-09-01

    Physical activity (PA) during normal pregnancy has various positive effects on pregnant women’s health. Determination of the relationship between PA and health outcomes requires accurate measurement of PA in pregnant women. The purpose of this review is to provide a summary of valid and reliable PA questionnaires for pregnant women. During 2013, Pubmed, OvidSP and Web of Science databases were searched for trials on measurement properties of PA questionnaires for pregnant population. Six studies and four questionnaires met the inclusion criteria: Pregnancy Physical Activity Questionnaire, Modified Kaiser Physical Activity Survey, Short Pregnancy Leisure Time Physical Activity Questionnaire and Third Pregnancy Infection and Nutrition Study Physical Activity Questionnaire. Assessment of validity and reliability was performed using correlations of the scores in these questionnaires with objective measures and subjective measures (self-report) of PA, as well as test-retest reliability coefficients. Sample sizes included in analysis varied from 45 to 177 subjects. The best validity and reliability characteristics (together with effect sizes) were identified for the Modified Kaiser Physical Activity Survey and Pregnancy Physical Activity Questionnaire (French, Vietnamese, standard). In conclusion, assessment of PA during pregnancy remains a challenging and complex task. Questionnaires are a simple and effective, yet limited tool for assessing PA.

  8. Self-Reported Benefits and Adverse Outcomes of Hot Yoga Participation.

    PubMed

    Mace, Casey; Eggleston, Brandon

    2016-01-01

    There is little to no scientific data about the health benefits or risks to participating in hot yoga, in particular distinguishing it from the practice of non-hot yoga. This study aims to provide some preliminary evidence about the risks and benefits of participating in hot yoga. Future studies will be able to build off the findings herein. This study utilized online survey software (Qualtrics) and recruited participants through convenience sampling (n = 157) by targeting yoga websites and online forums. As there is currently no known questionnaire that has been developed to assess the risks and benefits of hot yoga participation, an exploratory measure was designed to gain more detailed responses from participants. Descriptive epidemiological analyses we re conducted. Participants of hot yoga had a number of pre-existing health conditions. Both benefits and adverse outcomes were reported. The most frequently reported health benefits of hot yoga in this sample included increased flexibility (63%), improved mood (58%), increased fitness (43%), and improved stamina (42%). Just over half of the participants reported some sort of adverse event during a hot yoga session (n = 82). The most commonly reported adverse events included dizziness (60%), feeling light headed (61%), nausea (35%), and dehydration (34%), amongst others. Further study on the risks and benefits of hot yoga participation is required.

  9. Self-Reported Benefits and Adverse Outcomes of Hot Yoga Participation.

    PubMed

    Mace, Casey; Eggleston, Brandon

    2016-08-15

    There is little to no scientific data about the health benefits or risks to participating in hot yoga, in particular distinguishing it from the practice of non-hot yoga. This study aims to provide some preliminary evidence about the risks and benefits of participating in hot yoga. Future studies will be able to build off the findings herein. This study utilized online survey software (Qualtrics) and recruited participants through convenience sampling (n = 157) by targeting yoga websites and online forums. As there is currently no known questionnaire that has been developed to assess the risks and benefits of hot yoga participation, an exploratory measure was designed to gain more detailed responses from participants. Descriptive epidemiological analyses we re conducted. Participants of hot yoga had a number of pre-existing health conditions. Both benefits and adverse outcomes were reported. The most frequently reported health benefits of hot yoga in this sample included increased flexibility (63%), improved mood (58%), increased fitness (43%), and improved stamina (42%). Just over half of the participants reported some sort of adverse event during a hot yoga session (n = 82). The most commonly reported adverse events included dizziness (60%), feeling light headed (61%), nausea (35%), and dehydration (34%), amongst others. Further study on the risks and benefits of hot yoga participation is required.

  10. 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

  11. Benchmarks for multidimensional recovery after burn injury in young adults: the development, validation, and testing of the American Burn Association/Shriners Hospitals for Children young adult burn outcome questionnaire.

    PubMed

    Ryan, Colleen M; Schneider, Jeffrey C; Kazis, Lewis E; Lee, Austin; Li, Nien-Chen; Hinson, Michelle; Bauk, Helena; Peck, Michael; Meyer, Walter J; Palmieri, Tina; Pidcock, Frank S; Reilly, Debra; Tompkins, Ronald G

    2013-01-01

    Although data exist on burn survival, there are little data on long-term burn recovery. Patient-centered health outcomes are useful in monitoring and predicting recovery and evaluating treatments. An outcome questionnaire for young adult burn survivors was developed and tested. This 5-year (2003-2008) prospective, controlled, multicenter study included burned and nonburned adults ages 19 to 30 years. The Young Adult Burn Outcome Questionnaires were completed at initial contact, 10 days, and 6 and 12 months. Factor analysis established construct validity. Reliability assessments used Cronbach α and test-retest. Recovery patterns were investigated using generalized linear models, with generalized estimating equations using mixed models and random effects. Burned (n = 153) and nonburned subjects (n = 112) completed 620 questionnaires (47 items). Time from injury to first questionnaire administration was 157 ± 36 days (mean ± SEM). Factor analysis included 15 factors: Physical Function, Fine Motor Function, Pain, Itch, Social Function Limited by Physical Function, Perceived Appearance, Social Function Limited by Appearance, Sexual Function, Emotion, Family Function, Family Concern, Satisfaction With Symptom Relief, Satisfaction With Role, Work Reintegration, and Religion. Cronbach α ranged from 0.72 to 0.92, with 11 scales >0.8. Test-retest reliability ranged from 0.29 to 0.94, suggesting changes in underlying health status after burns. Recovery curves in five domains, Itch, Perceived Appearance, Social Function Limited by Appearance, Family Concern, and Satisfaction with Symptom Relief, remained below the reference group at 24 months. The Young Adult Burn Outcome Questionnaire is a reliable and valid instrument for multidimensional functional outcomes assessment. Recovery in some domains was incomplete.

  12. [Multifactor Organizational Stress Risk Questionnaire--MOSRQ: a preliminary study of dimensions and structure].

    PubMed

    Zuffo, Riccardo Giorgio; Ferretti, Maria Santa

    2012-01-01

    INTRODUCTION. The aim of the present study is to demonstrate the validity of the MOSRQ, a questionnaire for the assessment of work related stress risk. This questionnaire has 38 items: 19 related to organizational stressors and 19 to strains. Firstly, it was performed a critical analysis of instruments reported in scientific literature; then relevant items about sources and consequences of work related stress were selected in order to obtain the questionnaire. Finally MOSRQ was administered to a sample of 2314 subjects mainly employed in private firms belonging to industry and service sectors. MOSRQ obtains a good index of reliability (alpha = .89 for organizational stressor/antecedents and alpha = .92 for strain/outcome). Factor analysis presents a structure with 3 factors both for the antecedents and for the outcomes of work related stress. In conclusion, it is claimed that MOSRQ has the necessary psychometric characteristics for use in research as well as in organizational contexts.

  13. 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…

  14. Assessment of satisfaction and Quality of Life using self - reported questionnaires after urethroplasty: a prospective analysis

    PubMed Central

    Lucas, Eduardo Terra; Koff, Walter José; Rosito, Tiago Elias; Berger, Milton; Bortolini, Tiago; Silva, Brasil

    2017-01-01

    ABSTRACT Objectives To assess patient satisfaction and quality of life after urethroplasty using two different self-reported outcome measures and to compare it with objective clinical data. Materials and Methods We prospectively collected data from 35 consecutive patients who underwent urethroplasty from January 2013 to September 2014. Patient demographics, International Prostate Symptom Score (IPSS), quality of life score, urethral stricture surgery patient-reported outcome measure (USS-PROM), maximum flow rate (Qmax) and post-void residual urine were collected before, two and eight months after surgery. Failure occurred when any postoperative instrumentation was performed. General estimation equation was used to compare the results and linear regression analysis to correlate both questionnaires with objective data. Results Mean age was 61 years. Urethroplasties were equally divided between anastomotic and buccal mucosa grafts and 19 patients (59.3%) had a previous urethral procedure. Overall success rate was 87.5%. IPSS improved from a mean 19 at baseline to 5.32 at 8 months (p <0.001). The mean USS-PROM score also improved from 13.21 preoperatively to 3.36 after surgery (p <0.001) and 84.3% of patients were satisfied or very satisfied with surgical results. Mean Qmax increased from 4.64mL/s to 11mL/s (p <0.001). Strong negative correlation was found respectively between flow rate and USS-PROM (r=-0.531, p <0.001) and with IPSS (r=-0.512, p <0.001). Conclusions Significant improvements in urinary symptoms and in quality of life are expected after urethroplasty and they are correlated with objective measures. PMID:28128915

  15. Systematic content evaluation and review of measurement properties of questionnaires for measuring self-reported fatigue among older people.

    PubMed

    Egerton, Thorlene; Riphagen, Ingrid I; Nygård, Arnhild J; Thingstad, Pernille; Helbostad, Jorunn L

    2015-09-01

    The assessment of fatigue in older people requires simple and user-friendly questionnaires that capture the phenomenon, yet are free from items indistinguishable from other disorders and experiences. This study aimed to evaluate the content, and systematically review and rate the measurement properties of self-report questionnaires for measuring fatigue, in order to identify the most suitable questionnaires for older people. This study firstly involved identification of questionnaires that purport to measure self-reported fatigue, and evaluation of the content using a rating scale developed for the purpose from contemporary understanding of the construct. Secondly, for the questionnaires that had acceptable content, we identified studies reporting measurement properties and rated the methodological quality of those studies according to the COSMIN system. Finally, we extracted and synthesised the results of the studies to give an overall rating for each questionnaire for each measurement property. The protocol was registered with PROSPERO (CRD42013005589). Of the 77 identified questionnaires, twelve were selected for review after content evaluation. Methodological quality varied, and there was a lack of information on measurement error and responsiveness. The PROMIS-Fatigue item bank and short forms perform the best. The FACIT-Fatigue scale, Parkinsons Fatigue Scale, Perform Questionnaire, and Uni-dimensional Fatigue Impact Scale also perform well and can be recommended. Minor modifications to improve performance are suggested. Further evaluation of unresolved measurement properties, particularly with samples including older people, is needed for all the recommended questionnaires.

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

    PubMed

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

    2017-01-01

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

  17. Differences in self-reported outcomes of open prostatectomy patients and robotic prostatectomy patients in an international web-based survey.

    PubMed

    O'Shaughnessy, Peter Kevin; Laws, Thomas A; Pinnock, Carol; Moul, Judd W; Esterman, Adrian

    2013-12-01

    To compare patient reported outcomes between robotic assisted surgery and non-robotic assisted surgery. This was an international web-based survey based on a qualitative research and literature review, an internet-based questionnaire was developed with approximately 70 items. The questionnaire included both closed and open-ended questions. Responses were received from 193 men of whom 86 had received either open (OP) or robotic (RALP) surgery. A statistically significant (p=0.027), ranked analysis of covariance was found demonstrating higher recent distress in the robotic (RALP) surgery group. Although not statistically significant, there was a pattern of men having robotic (RALP) surgery reporting fewer urinary and bowel problems, but having a greater rate of sexual dysfunction. Men who opt for robotic surgery may have higher expectations for robotic (RALP) surgery, when these expectations are not fully met they may be less likely to accept the consequences of this major cancer surgery. Information regarding surgical choice needs to be tailored to ensure that men diagnosed with prostate cancer are fully informed of not only short term surgical and physical outcomes such as erectile dysfunction and incontinence, but also of potential issues with regards to masculinity, lifestyle and sexual health. Copyright © 2013. Published by Elsevier Ltd.

  18. Quality of life questionnaires in otorhinolaryngology: a systematic overview.

    PubMed

    Koenraads, S P C; Aarts, M C J; van der Veen, E L; Grolman, W; Stegeman, I

    2016-12-01

    The importance of quality of life (QOL) as an endpoint and the use of validated QOL questionnaires have increased over time. To evaluate health-related quality of life (HR-QOL) measurement instruments used in patients in otorhinolaryngology (ORL). We aimed to establish the use of QOL questionnaires in ORL over a period of time, establish the use of QOL questionnaires within different domains and determine the use of validated QOL questionnaires. We performed a comprehensive search in PubMed up to 1 January 2014. Articles were included that measured HR-QOL questionnaires in clinical practice in children, adolescents or adults in 42 journals of ORL. Multiple unique QOL questionnaires, organised according to domain, time and survey of validation, were extracted from reported articles. Of 2442 articles, we utilised 1196 publications with a total of 2103 QOL questionnaires regarding ORL. We evaluated a variety of 363 unique QOL questionnaires in which 60% (n = 220) QOL questionnaires had been validated. We found a continuing increase in the amount of articles which used QOL questionnaires since the beginning of the 20th century, while the percentage of validated QOL questionnaires remained the same (76%). Most QOL questionnaires were used in the domains oncology (35%), otology (21%) and rhinology (20%). The domain otology had the largest amount of unique QOL questionnaires (n = 122). We identified and evaluated all unique HR-QOL questionnaires utilised in patients in ORL. Recently, the use of validated and non-validated HR-QOL questionnaires has increased within all domains of ORL. The assessment of QOL has become an important outcome measure in clinical practice, in medical research and for healthcare organisations. © 2015 John Wiley & Sons Ltd.

  19. Relationship between hospital financial performance and publicly reported outcomes.

    PubMed

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

    2016-07-01

    Hospitals that have robust financial performance may have improved publicly reported outcomes. To assess the relationship between hospital financial performance and publicly reported outcomes of care, and to assess whether improved outcome metrics affect subsequent hospital financial performance. Observational cohort study. Hospital financial data from the Office of Statewide Health Planning and Development in California in 2008 and 2012 were linked to data from the Centers for Medicare and Medicaid Services Hospital Compare website. Hospital financial performance was measured by net revenue by operations, operating margin, and total margin. Outcomes were 30-day risk-standardized mortality and readmission rates for acute myocardial infarction (AMI), congestive heart failure (CHF), and pneumonia (PNA). Among 279 hospitals, there was no consistent relationship between measures of financial performance in 2008 and publicly reported outcomes from 2008 to 2011 for AMI and PNA. However, improved hospital financial performance (by any of the 3 measures) was associated with a modest increase in CHF mortality rates (ie, 0.26% increase in CHF mortality rate for every 10% increase in operating margin [95% confidence interval: 0.07%-0.45%]). Conversely, there were no significant associations between outcomes from 2008 to 2011 and subsequent financial performance in 2012 (P > 0.05 for all). Robust financial performance is not associated with improved publicly reported outcomes for AMI, CHF, and PNA. Financial incentives in addition to public reporting, such as readmissions penalties, may help motivate hospitals with robust financial performance to further improve publicly reported outcomes. Reassuringly, improved mortality and readmission rates do not necessarily lead to loss of revenue. Journal of Hospital Medicine 2016;11:481-488. © 2016 Society of Hospital Medicine. © 2016 Society of Hospital Medicine.

  20. Assessment of short and long-term outcomes of diabetes patient education using the health education impact questionnaire (HeiQ).

    PubMed

    Laursen, Ditte Hjorth; Christensen, Karl Bang; Christensen, Ulla; Frølich, Anne

    2017-06-15

    Type 2 diabetes is a progressive chronic illness that will affect more than 500 million people worldwide by 2030. It is a significant cause of morbidity and mortality. Finding the right care management for diabetes patients is necessary to effectively address the growing population of affected individuals and escalating costs. Patient education is one option for improving patient self-management. However, there are large discrepancies in the outcomes of such programs and long-term data are lacking. We assessed the short and long-term outcomes of diabetes patient education using the health education impact questionnaire (HeiQ). We conducted a observational cohort study of 83 type 2 diabetes patients participating in patient education programs in Denmark. The seven-scale HeiQ was completed by telephone interview at baseline and 2 weeks (76 participants, 93%) and 12 months (66, 80%) after the patient education ended. Changes over time were assessed using mean values and standard deviation at each time point and Cohen effect sizes. Patients reported improvements 2 weeks after the program ended in 4 of 7 constructs: skills and technique acquisition (ES = 0.59), self-monitoring and insight (ES = 0.52), constructive attitudes and approaches (ES = 0.43) and social integration and support (ES = 0.27). After 12 months, patients reported improvements in 3 of 7 constructs: skills and technique acquisition (ES = 0.66), constructive attitudes and approaches (ES = 0.43), and emotional wellbeing (ES = 0.44). Skills and technique showed the largest short- and long-term effect size. No significant changes were found in health-related activity or positive and active engagement in life over time. After 12 months, diabetes patients who participated in patient education demonstrated increased self-management skills, improved acceptance of their chronic illness and decreased negative emotional response to their disease. Applying HeiQ as an outcome measure yielded new

  1. Reporting clinical outcomes of breast reconstruction: a systematic review.

    PubMed

    Potter, S; Brigic, A; Whiting, P F; Cawthorn, S J; Avery, K N L; Donovan, J L; Blazeby, J M

    2011-01-05

    Breast reconstruction after mastectomy for cancer requires accurate evaluation to inform evidence-based participatory decision making, but the standards of outcome reporting after breast reconstruction have not previously been considered. We used extensive searches to identify articles reporting surgical outcomes of breast reconstruction. We extracted data using published criteria for complication reporting modified to reflect reconstructive practice. Study designs included randomized controlled trials, cohort studies, and case series. The Cochrane Risk of Bias tool was used to critically appraise all study designs. Other criteria used to assess the studies were selection and funding bias, statistical power calculations, and institutional review board approval. Wilcoxon signed rank tests were used to compare the breadth and frequency of study outcomes, and χ² tests were used to compare the number of studies in each group reporting each of the published criteria. All statistical tests were two-sided. Surgical complications following breast reconstruction in 42,146 women were evaluated in 134 studies. These included 11 (8.2%) randomized trials, 74 (55.2%) cohort studies, and 49 (36.6%) case series. Fifty-three percent of studies demonstrated a disparity between methods and results in the numbers of complications reported. Complications were defined by 87 (64.9%) studies and graded by 78 (58.2%). Details such as the duration of follow-up and risk factors for adverse outcomes were omitted from 47 (35.1%) and 58 (43.3%) studies, respectively. Overall, the studies defined fewer than 20% of the complications they reported, and the definitions were largely inconsistent. The results of this systematic review suggest that outcome reporting in breast reconstruction is inconsistent and lacks methodological rigor. The development of a standardized core outcome set is recommended to improve outcome reporting in breast reconstruction.

  2. Whose quality of life? Ethical implications in patient-reported health outcome measurement.

    PubMed

    Hagell, Peter; Reimer, Jan; Nyberg, Per

    2009-06-01

    Patient-reported health status questionnaires intend to assess illness and therapy from the patients' perspective. To provide fair and valid assessments, they should be equally relevant to major subsets of respondents. Furthermore, disease-specific measures are assumed to be perceived as more relevant than generic ones. This study assessed these assumptions among people with Parkinson's disease. Cross-sectional data from 202 people with Parkinson's disease (54% men; mean age, 70) were analyzed regarding patient-rated relevance and predictors of patient-rated poor relevance of two generic [the 36-item Short Form Health Survey (SF-36) and Nottingham Health Profile (NHP)] and one disease-specific [Parkinson's Disease Questionnaire (PDQ-39)] health status questionnaire. There were no differences in relevance ratings across the questionnaires. Poorer overall quality of life [odds ratio (OR), 2.459] and mental health (OR, 1.023) were associated with poorer patient-rated relevance of the SF-36, and higher age was associated with poorer patient-rated relevance of the PDQ-39 (OR, 1.040). No significant predictors were found for the NHP. The PDQ-39 failed to meet the assumption that disease-specific scales are more relevant than generic ones. Nevertheless, the most important implication of this study is an ethical one. Because the relevance of the SF-36 and PDQ-39 is perceived as poorer by those who fare least well and by older people, these scales may not reflect the perspectives of these groups. This challenges bioethical principles and threatens scientific validity. Perceived relevance of patient-centered outcomes needs to be considered, or the voice of vulnerable groups may be silenced, fair inferences prohibited, and opportunities for improved care lost.

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

    PubMed Central

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

    2016-01-01

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

  4. Vascular Access Outcomes Reported in Maintenance Hemodialysis Trials: A Systematic Review.

    PubMed

    Viecelli, Andrea K; O'Lone, Emma; Sautenet, Benedicte; Craig, Jonathan C; Tong, Allison; Chemla, Eric; Hooi, Lai-Seong; Lee, Timmy; Lok, Charmaine; Polkinghorne, Kevan R; Quinn, Robert R; Vachharajani, Tushar; Vanholder, Raymond; Zuo, Li; Irish, Ashley B; Mori, Trevor A; Pascoe, Elaine M; Johnson, David W; Hawley, Carmel M

    2018-03-01

    Many randomized controlled trials have been performed with the goal of improving outcomes related to hemodialysis vascular access. If the reported outcomes are relevant and measured consistently to allow comparison of interventions across trials, such trials can inform decision making. This study aimed to assess the scope and consistency of vascular access outcomes reported in contemporary hemodialysis trials. Systematic review. Adults requiring maintenance hemodialysis. All randomized controlled trials and trial protocols reporting vascular access outcomes identified from ClinicalTrials.gov, Embase, MEDLINE, and the Cochrane Kidney and Transplant Specialized Register from January 2011 to June 2016. Any hemodialysis-related intervention. The frequency and characteristics of vascular access outcome measures were analyzed and classified. From 168 relevant trials, 1,426 access-related outcome measures were extracted and classified into 23 different outcomes. The 3 most common outcomes were function (136 [81%] trials), infection (63 [38%]), and maturation (31 [18%]). Function was measured in 489 different ways, but most frequently reported as "mean access blood flow (mL/min)" (37 [27%] trials) and "number of thromboses" (30 [22%]). Infection was assessed in 136 different ways, with "number of access-related infections" being the most common measure. Maturation was assessed in 44 different ways at 15 different time points and most commonly characterized by vein diameter and blood flow. Patient-reported outcomes, including pain (19 [11%]) and quality of life (5 [3%]), were reported infrequently. Only a minority of trials used previously standardized outcome definitions. Restricted sampling frame for feasibility and focus on contemporary trials. The reporting of access outcomes in hemodialysis trials is very heterogeneous, with limited patient-reported outcomes and infrequent use of standardized outcome measures. Efforts to standardize outcome reporting for vascular

  5. Spanish Cultural Adaptation of the Questionnaire Early Arthritis for Psoriatic Patients.

    PubMed

    García-Gavín, J; Pérez-Pérez, L; Tinazzi, I; Vidal, D; McGonagle, D

    2017-12-01

    The Early Arthritis for Psoriatic patients (EARP) questionnaire is a screening tool for psoriatic arthritis. The original Italian version has good measurement properties but the EARP required translation and adaptation for use in Spain. This article describes the cultural adaptation process as a step prior to validation. We used the principles of good practice for the cross-cultural adaptation of patient-reported outcomes measurement established by the International Society Pharmacoeconomics and Outcome Research. The steps in this process were preparation, forward translation, reconciliation, back-translation and review, harmonization, cognitive debriefing and review, and proofreading. During preparation the developers of the original questionnaire were asked for their permission to adapt the EARP for use in Spain and to act as consultants during the process. The original questionnaire was translated into Spanish by native Spanish translators, who made slight changes that were approved by the questionnaire's developers. The Spanish version was then back-translated into Italian; that version was reviewed to confirm equivalence with the original Italian text. The reconciled Spanish EARP was then tested for comprehensibility and interpretation in a group of 35 patients. All the patients answered all items without making additional comments. This cultural adaptation of the EARP questionnaire for Spanish populations is the first step towards its later use in routine clinical practice. The application of a cross-cultural adaptation method ensured equivalence between the original and Spanish versions of the EARP. The Spanish questionnaire will be validated in a second stage. Copyright © 2017 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.

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

    PubMed Central

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

    2017-01-01

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

  7. [Assessment of the outcome of anorexia nervosa: construction of a self-administered questionnaire based on the patients' perception].

    PubMed

    Ronze, M; Mamelle, N; Combe, C; Pugeat, M

    2010-02-01

    Our working hypothesis is that a better insight into the outcome of patients suffering from anorexia nervosa should contribute to preventing relapses and further complications and assessing treatment efficiency. Through anorexia nervosa, the patients express the difficulty they have to view themselves as specific subjects. The current classic outcome evaluation is based on the study of objective events, which only partially reflect the reality of the patients' outcome at a subjective level. The objective of this study was to set up a new assessing instrument of the outcome of patients suffering from anorexia nervosa, essentially based on the patients' perception of their experience. The methodology used has been based on: (1) the conduct by the main investigator of unstructured interviews using "free association", with the help of an interview guide. The anorexia nervosa patients were recruited among those who were hospitalized on an isolation contract, or among outpatients under a psychiatrist/psychoanalyst's supervision, aged over 25 years old so that they may have started their reproductive life. The study included 30 patients; (2) the analysis of the interview contents backed by preexisting hypotheses and by new ones suggested by the expression of the patients' perception, so as to set up an inventory of new themes; (3) the construction of a self-administered questionnaire starting from the development of each theme into several questions taking up the patients' own words and offering 4 possible answers (disagree completely, disagree, agree, quite agree). The analysis of the interviews contents has led to the development of 11 themes. The self-administered questionnaire includes a total of 124 items stemming from the development of each theme into between 9 and 16 items that were mixed in the version submitted to patients. This original interpretation of the outcome of the patients through their experience provides a better understanding of their relation to

  8. Can Questionnaire Reports Correctly Classify Relationship Distress and Partner Physical Abuse?

    PubMed Central

    Heyman, Richard E.; Feldbau-Kohn, Shari R.; Ehrensaft, Miriam K.; Langhinrichsen-Rohling, Jennifer; O’Leary, K. Daniel

    2006-01-01

    Relationship adjustment (e.g., Dyadic Adjustment Scale; DAS) and physical aggression (e.g., Conflict Tactics Scale) measures are used both as screening tools and as the sole criterion for classification. This study created face valid diagnostic interviews for relationship distress and physical abuse, through which one could compare preliminarily the classification properties of questionnaire reports. The DAS (and a global measure of relationship satisfaction) had modest agreement with a structured diagnostic interview; both questionnaires tended to overdiagnose distress compared with the interview. Results for partner abuse reiterated the need to go beyond occurrence of aggression as the sole diagnostic criterion, because men’s aggression was more likely than women’s to rise to the level of “abuse” when diagnostic criteria (injury or substantial fear) were applied. PMID:11458637

  9. Parents' self-efficacy, outcome expectations, and self-reported task performance when managing atopic dermatitis in children: instrument reliability and validity.

    PubMed

    Mitchell, Amy E; Fraser, Jennifer A

    2011-02-01

    Support and education for parents faced with managing a child with atopic dermatitis is crucial to the success of current treatments. Interventions aiming to improve parent management of this condition are promising. Unfortunately, evaluation is hampered by lack of precise research tools to measure change. To develop a suite of valid and reliable research instruments to appraise parents' self-efficacy for performing atopic dermatitis management tasks; outcome expectations of performing management tasks; and self-reported task performance in a community sample of parents of children with atopic dermatitis. The Parents' Eczema Management Scale (PEMS) and the Parents' Outcome Expectations of Eczema Management Scale (POEEMS) were developed from an existing self-efficacy scale, the Parental Self-Efficacy with Eczema Care Index (PASECI). Each scale was presented in a single self-administered questionnaire, to measure self-efficacy, outcome expectations, and self-reported task performance related to managing child atopic dermatitis. Each was tested with a community sample of parents of children with atopic dermatitis, and psychometric evaluation of the scales' reliability and validity was conducted. A community-based convenience sample of 120 parents of children with atopic dermatitis completed the self-administered questionnaire. Participants were recruited through schools across Australia. Satisfactory internal consistency and test-retest reliability was demonstrated for all three scales. Construct validity was satisfactory, with positive relationships between self-efficacy for managing atopic dermatitis and general perceived self-efficacy; self-efficacy for managing atopic dermatitis and self-reported task performance; and self-efficacy for managing atopic dermatitis and outcome expectations. Factor analyses revealed two-factor structures for PEMS and PASECI alike, with both scales containing factors related to performing routine management tasks, and managing the

  10. 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

  11. 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.

  12. How patient outcomes are reported in drug advertisements.

    PubMed

    Lexchin, J

    1999-05-01

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

  13. A systematic review of patient reported outcome measures (PROMs) used in child and adolescent burn research.

    PubMed

    Griffiths, C; Armstrong-James, L; White, P; Rumsey, N; Pleat, J; Harcourt, D

    2015-03-01

    Patient reported outcome measures (PROMs) can identify important information about patient needs and therapeutic progress. The aim of this review was to identify the PROMs that are being used in child and adolescent burn care and to determine the quality of such scales. Computerised and manual bibliographic searches of Medline, Social Sciences Index, Cinahl, Psychinfo, Psycharticles, AMED, and HAPI, were used to identify English-language articles using English-language PROMs from January 2001 to March 2013. The psychometric quality of the PROMs was assessed. 23 studies met the entry criteria and identified 32 different PROMs (31 generic, 1 burns-specific). Overall, the psychometric quality of the PROMs was low; only two generic scales (the Perceived Stigmatisation Questionnaire and the Social Comfort Scale) and only one burns-specific scale (the Children Burn Outcomes Questionnaire for children aged 5-18) had psychometric evidence relevant to this population. The majority of PROMs did not have psychometric evidence for their use with child or adolescent burn patients. To appropriately identify the needs and treatment progress of child and adolescent burn patients, new burns-specific PROMs need to be developed and validated to reflect issues that are of importance to this population. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.

  14. Standardized reporting using CODES (Crash Outcome Data Evaluation System)

    DOT National Transportation Integrated Search

    1999-12-01

    While CODES projects have expanded to 25 states, there is no standardized reporting of the outcome measures that are available with linked data. This paper describes our efforts to build a standard format for reporting these outcomes. This format is ...

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

    PubMed

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

    2014-01-01

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

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

    PubMed Central

    2014-01-01

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

  17. Patient-Reported Outcome Questionnaire for Systemic Mastocytosis

    ClinicalTrials.gov

    2017-01-06

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

  18. Psychometric properties of the Kids' Child Feeding Questionnaire-Restriction.

    PubMed

    Stromberg, Sarah E; Minski, Samantha; Wheeler, Paris B; Chardon, Marie L; Janicke, David M

    Research exploring parental restrictive feeding is mixed and shows that it both negatively and positively affects children's dietary intake. One hypothesis for these inconsistent findings is the use of parent-report vs. youth-report measures of parental restrictive feeding, but there are limited psychometrically-sound youth-report measures of this construct. Therefore, the current study aims to evaluate the psychometric properties of a measure of parent restrictive feeding practices, the Kids' Child Feeding Questionnaire-Restriction (KCFQ-R), from the youth perspective. The 7-item, youth-report KCFQ-R is composed of the restriction subscale from the Kids' Child Feeding Questionnaire. This measure was completed by 225 youth attending a primary care appointment. Initial exploratory factor analysis and communalities yielded a single factor solution explaining 39.93% of the variability in the data. Internal consistency using the seven items was .73. The KCFQ-R demonstrated external validity through its significant relationship with parent concern about child overweight. Results provide preliminary support that the KCFQ-R is a psychometrically sound and reliable measure of youth-reported parental restrictive feeding practices. Given the mixed research on the effects of parent-reported parental feeding restriction on various child outcomes, this youth-report measure may help clarify these relationships. Future research should examine youth-report measures of other parent feeding domains. Copyright © 2017 Asia Oceania Association for the Study of Obesity. All rights reserved.

  19. Clinical Outcome Reporting in Youth ACL Literature Is Widely Variable

    PubMed Central

    Brusalis, Christopher M.; Lakomkin, Nikita; Suryavanshi, Joash R.; Cruz, Aristides I.; Green, Daniel W.; Jones, Kristofer J.; Fabricant, Peter D.

    2017-01-01

    Background: Advances in anterior cruciate ligament (ACL) reconstruction procedures in pediatric and adolescent patients have resulted in an increase in recent clinical studies on this topic. However, the consistency with which outcome measures are reported in this demographic is unknown. Purpose: To document outcome reporting patterns of youth ACL reconstruction studies in high-impact journals. Study Design: Systematic review; Level of evidence, 4. Methods: All articles published in 5 high-impact orthopaedic journals from 2010 to 2016 were reviewed to identify those reporting clinical outcomes of young patients who underwent ACL reconstruction. Studies that were nonclinical, reported on patients older than 18 years, or included fewer than 10 patients were excluded. Outcome measures used in all included studies were recorded. Results: Seventeen studies encompassing 772 subjects (mean age, 14.3 years; range, 6.3-18.0 years) were analyzed. Eight studies (47%) reported on Tanner stage of subjects, while 1 study reported skeletal age. Ten studies (59%) clearly documented the presence or absence of surgical complications. Range of motion was reported in 65% of studies. Leg-length discrepancy and angular deformity were each reported in 76% of studies, with 12% quantifying results through radiographic measurements. Ligament testing was variably defined by inclusion of instrumented testing (65%), Lachman test (53%), and pivot-shift test (53%). Fourteen studies (82%) explicitly reported on the rate of ACL rerupture, while 71% reported on the rate of revision surgery. Rate of return to preinjury activity was reported in 8 studies (47%), of which 2 defined criteria for return to sport and 3 defined the level of competitive sport. Patient-reported outcome measures (PROMs) were used variably. For the 3 most commonly reported PROMs (Lysholm, International Knee Documentation Committee, and Tegner), 24% of studies reported all 3 PROMs, 35% of studies reported 2 PROMs, and 6% of

  20. [Shoulder disability questionnaires: a systematic review].

    PubMed

    Fayad, F; Mace, Y; Lefevre-Colau, M M

    2005-07-01

    To identify all available shoulder disability questionnaires designed to measure physical functioning and to examine those with satisfactory clinimetric quality. We used the Medline database and the "Guide des outils de mesure de l'évaluation en médecine physique et de réadaptation" textbook to search for questionnaires. Analysis took into account the development methodology, clinimetric quality of the instruments and frequency of their utilization. We classified the instruments according to the International Classification of Functioning, Disability and Health. Thirty-eight instruments have been developed to measure disease-, shoulder- or upper extremity-specific outcome. Four scales assess upper-extremity disability and 3 others shoulder disability. We found 6 scales evaluating disability and shoulder pain, 7 scales measuring the quality of life in patients with various conditions of the shoulder, 14 scales combining objective and subjective measures, 2 pain scales and 2 unclassified scales. Older instruments developed before the advent of modern measurement development methodology usually combine objective and subjective measures. Recent instruments were designed with appropriate methodology. Most are self-administered questionnaires. Numerous shoulder outcome measure instruments are available. There is no "gold standard" for assessing shoulder function outcome in the general population.

  1. Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study (APPROACH-IS): rationale, design, and methods.

    PubMed

    Apers, Silke; Kovacs, Adrienne H; Luyckx, Koen; Alday, Luis; Berghammer, Malin; Budts, Werner; Callus, Edward; Caruana, Maryanne; Chidambarathanu, Shanthi; Cook, Stephen C; Dellborg, Mikael; Enomoto, Junko; Eriksen, Katrine; Fernandes, Susan M; Jackson, Jamie L; Johansson, Bengt; Khairy, Paul; Kutty, Shelby; Menahem, Samuel; Rempel, Gwen; Sluman, Maayke A; Soufi, Alexandra; Thomet, Corina; Veldtman, Gruschen; Wang, Jou-Kou; White, Kamila; Moons, Philip

    2015-01-20

    Data on patient-reported outcomes (PROs) in adults with congenital heart disease (CHD) are inconsistent and vary across the world. Better understanding of PROs and their differences across cultural and geographic barriers can best be accomplished via international studies using uniform research methods. The APPROACH-IS consortium (Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study) was created for this purpose and investigates PROs in adults with CHD worldwide. This paper outlines the project rationale, design, and methods. APPROACH-IS is a cross-sectional study. The goal is to recruit 3500-4000 adults with CHD from 15 countries in five major regions of the world (Asia, Australia, Europe, North and South America). Self-report questionnaires are administered to capture information on PRO domains: (i) perceived health status (12-item Short-form Health Survey & EuroQOL-5D); (ii) psychological functioning (Hospital Anxiety and Depression Scale); (iii) health behaviors (Health-Behavior Scale-Congenital Heart Disease); and (iv) quality of life (Linear Analog Scale & Satisfaction With Life Scale). Additionally, potential explanatory variables are assessed: (i) socio-demographic variables; (ii) medical history (chart review); (iii) sense of coherence (Orientation to Life Questionnaire); and (iv) illness perceptions (Brief Illness Perception Questionnaire). Descriptive analyses and multilevel models will examine differences in PROs and investigate potential explanatory variables. APPROACH-IS represents a global effort to increase research understanding and capacity in the field of CHD, and will have major implications for patient care. Results will generate valuable information for developing interventions to optimize patients' health and well-being. ClinicalTrials.gov: NCT02150603. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  2. Cross-cultural equivalence of the patient- and parent-reported quality of life in short stature youth (QoLISSY) questionnaire.

    PubMed

    Bullinger, Monika; Quitmann, Julia; Silva, Neuza; Rohenkohl, Anja; Chaplin, John E; DeBusk, Kendra; Mimoun, Emmanuelle; Feigerlova, Eva; Herdman, Michael; Sanz, Dolores; Wollmann, Hartmut; Pleil, Andreas; Power, Michael

    2014-01-01

    Testing cross-cultural equivalence of patient-reported outcomes requires sufficiently large samples per country, which is difficult to achieve in rare endocrine paediatric conditions. We describe a novel approach to cross-cultural testing of the Quality of Life in Short Stature Youth (QoLISSY) questionnaire in five countries by sequentially taking one country out (TOCO) from the total sample and iteratively comparing the resulting psychometric performance. Development of the QoLISSY proceeded from focus group discussions through pilot testing to field testing in 268 short-statured patients and their parents. To explore cross-cultural equivalence, the iterative TOCO technique was used to examine and compare the validity, reliability, and convergence of patient and parent responses on QoLISSY in the field test dataset, and to predict QoLISSY scores from clinical, socio-demographic and psychosocial variables. Validity and reliability indicators were satisfactory for each sample after iteratively omitting one country. Comparisons with the total sample revealed cross-cultural equivalence in internal consistency and construct validity for patients and parents, high inter-rater agreement and a substantial proportion of QoLISSY variance explained by predictors. The TOCO technique is a powerful method to overcome problems of country-specific testing of patient-reported outcome instruments. It provides an empirical support to QoLISSY's cross-cultural equivalence and is recommended for future research.

  3. Quality of life and discriminating power of two questionnaires in fibromyalgia patients: Fibromyalgia Impact Questionnaire and Medical Outcomes Study 36-Item Short-Form Health Survey.

    PubMed

    Assumpção, Ana; Pagano, Tatiana; Matsutani, Luciana A; Ferreira, Elizabeth A G; Pereira, Carlos A B; Marques, Amélia P

    2010-01-01

    Fibromyalgia is a painful syndrome characterized by widespread chronic pain and associated symptoms with a negative impact on quality of life. Considering the subjectivity of quality of life measurements, the aim of this study was to verify the discriminating power of two quality of life questionnaires in patients with fibromyalgia: the generic Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and the specific Fibromyalgia Impact Questionnaire (FIQ). A cross-sectional study was conducted on 150 participants divided into Fibromyalgia Group (FG) and Control Group (CG) (n=75 in each group). The participants were evaluated using the SF-36 and the FIQ. The data were analyzed by the Student t-test (α=0.05) and inferential analysis using the Receiver Operating Characteristics (ROC) Curve--sensitivity, specificity and area under the curve (AUC). The significance level was 0.05. The sample was similar for age (CG: 47.8 ± 8.1; FG: 47.0 ± 7.7 years). A significant difference was observed in quality of life assessment in all aspects of both questionnaires (p<0.05). Higher sensibility, specificity and AUC were obtained by the FIQ (96%, 96%, 0.985, respectively), followed by the SF-36 (88%, 89% and 0.948 AUC). The FIQ presented the highest sensibility, specificity and AUC showing the most discriminating power. However the SF-36 is also a good instrument to assess quality of life in fibromyalgia patients, and we suggest that both should be used in parallel because they evaluate relevant and complementary aspects of quality of life.

  4. How psychosocial factors affect well-being of practice assistants at work in general medical care?--a questionnaire survey.

    PubMed

    Goetz, Katja; Berger, Sarah; Gavartina, Amina; Zaroti, Stavria; Szecsenyi, Joachim

    2015-11-11

    Well-being at work is an important aspect of a workforce strategy. The aim of the study was to explore and evaluate psychosocial factors and health and work-related outcomes of practices assistants depending on their employment status in general medical practices. This observational study was based on a questionnaire survey to evaluate psychosocial aspects at work in general medical practices. A standardized questionnaire was used, the Copenhagen Psychosocial Questionnaire (COPSOQ). Beside descriptive analyses linear regression analyses were performed for each health and work-related outcome scale of the COPSOQ. 586 practice assistants out of 794 respondents (73.8 %) from 234 general medical practices completed the questionnaire. Practice assistants reported the highest scores for the psychosocial factor 'sense of community' (mean = 85.9) and the lower score for 'influence at work' (mean = 41.2). Moreover, practice assistants who worked part-time rated their psychosocial factors at work and health-related outcomes more positively than full-time employees. Furthermore, the two scales of health related outcomes 'burnout' and 'job satisfaction' showed strong associations between different psychosocial factors and socio-demographic variables. Psychosocial factors at work influence well-being at work and could be strong risk factors for poor health and work-related outcomes. Effective management of these issues could have an impact on the retention and recruitment of health care staff.

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

    PubMed

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

    2016-06-20

    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. Retrospective analysis of prospectively collected data. Single centre series. Outpatient clinics at an elective foot and ankle unit in the UK. All new adult patients attending elective orthopaedic outpatient clinics over a 32-month period. 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. 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. 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). This study demonstrates the successful implementation of technology into a service improvement programme

  6. Impact of gastrointestinal events on patient-reported outcomes in Asia-Pacific women with osteoporosis: baseline results of the MUSIC OS-AP study.

    PubMed

    Modi, A; Ebeling, P R; Lee, M S; Min, Y K; Mithal, A; Yang, X; Baidya, S; Sen, S; Sajjan, S

    2017-12-01

    The purpose of this study was to describe the impact of gastrointestinal events on patient-reported outcomes and health care resource use among Asia-Pacific women with postmenopausal osteoporosis. The results of this study show that gastrointestinal events decreased adherence, treatment satisfaction, and quality of life in Asia-Pacific women with postmenopausal osteoporosis. This study aimed to describe the impact of gastrointestinal (GI) events on patient-reported outcomes and health care resource use among Asia-Pacific women with postmenopausal osteoporosis. The MUSIC OS-AP study included an observational cohort study of postmenopausal women with osteoporosis. Women were classified as untreated or treated, with treated patients further classified as new or experienced users. Adherence was measured by the Adherence Evaluation of Osteoporosis treatment (ADEOS) questionnaire, treatment satisfaction by the Osteoporosis Patient Satisfaction Questionnaire (OPSAT) while general health-related and osteoporosis-specific quality of life were measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire and the Osteoporosis Assessment Questionnaire (OPAQ), respectively. The association of GI events with these outcomes was determined by covariate-adjusted regression analysis of least squares mean differences in the scores of treated patients with and without GI events. Resource utilization was measured as the number of physician visits over the past 3 months, and multivariate regression analysis was used to assess the association of GI events with the likelihood of a visit. The GI event profile, quality of life scores, and resource use were numerically similar in untreated and treated women. The rate of adherence among treated women was higher in experienced than in new users. As indicated by mean scores, experienced users had better quality of life and slightly higher treatment satisfaction and fewer physician visits than new users. Except for adherence in

  7. Quality-of-Life Outcomes Following Surface Electromyography Biofeedback as an Adjunct to Pelvic Floor Muscle Training for Urinary Incontinence: A Case Report

    PubMed Central

    Hill, Alexandra; Alappattu, Meryl

    2018-01-01

    Background A non-invasive treatment for urinary incontinence (UI) is surface electromyography (sEMG) biofeedback with pelvic floor muscle (PFM) training. A lack of consensus and evidence exists on the Quality of Life (QoL) outcomes following sEMG biofeedback using surface electrodes at the perineum compared to the more invasive intravaginal probe. This case report examines QoL using sEMG biofeedback at the perineum with PFM training for UI. Study Design Single subject case report Case Description The patient was a 61-year-old woman diagnosed with UI. Her chief complaints were nocturia, urine leakage with urgency, and urine leakage with sneezing and coughing. Physical therapy (PT) treatment focused on behavioral modification, PFM strengthening with and without sEMG biofeedback, and therapeutic exercises with PFM contractions. Outcomes At four weeks from baseline, the patient’s PFM strength increased from 2/5 to 4/5 based on the Modified Laycock Scale. Her PFM endurance contraction improved from two seconds to ten seconds. The International Continence Impact Questionnaire – Urinary Incontinence Short Form (ICIQ-UI SF) score decreased from 6 to 0, the Incontinence Impact Questionnaire – Short Form (IIQ-7) score decreased from 14.3 to 0, and the 3 Incontinence Questions (3IQ) responses did not change. Discussion The outcomes from this case report demonstrate a brief course of PT treatment consisting of perineal sEMG biofeedback in conjunction with PFM training demonstrated clinically meaningful improvements in incontinence-related QoL, in addition to improvements in motor function in a woman with mixed UI and nocturia. PMID:29375282

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

    PubMed

    Holzner, Bernhard; Giesinger, Johannes M; Pinggera, Jakob; Zugal, Stefan; Schöpf, Felix; Oberguggenberger, Anne S; Gamper, Eva M; Zabernigg, August; Weber, Barbara; Rumpold, Gerhard

    2012-11-09

    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. 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. 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. 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 on extending cancer registries with PRO data

  9. 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

  10. Reliability and validity of the German version of the Utrecht Questionnaire for Outcome Assessment in Aesthetic Rhinoplasty (D-OAR).

    PubMed

    Spiekermann, Christoph; Rudack, Claudia; Stenner, Markus

    2017-11-01

    The outcome of aesthetic rhinoplasty is determined by the patient's subjective satisfaction with the nasal appearance which is difficult to assess. The Utrecht Questionnaire for Outcome Assessment in Aesthetic Rhinoplasty (OAR) is a brief and reliable instrument to assess the influence of the subjective nasal appearance on quality of life in patients undergoing aesthetic rhinoplasty. Preoperative application of this questionnaire reveals important aspects and possible disturbances of the body image which could be negative predictors concerning the result. On the other hand, it represents an appropriate tool to assess the postoperative outcome. The aim of this study was to determine the validity, reliability and responsiveness of the adapted German version of the OAR (D-OAR). The adaption of the OAR to German language was performed by a forward and backward translation process. Patients undergoing rhinoplasty were asked to complete the D-OAR preoperatively, 1, 3 and 12 months after procedure and healthy volunteers without any nasal complaints served as controls to test validity, reliability and responsiveness. An excellent internal consistency, a good test-retest reliability and good inter-item and item-total correlations demonstrated a good reliability of the D-OAR. The convincing validity of the adapted version was proven by an excellent discriminant and a sufficient content validity. Significant differences between pre- and postoperative D-OAR scores revealed a good responsiveness of the instrument. Hence, with a sufficient validity, reliability and sensitivity to changes, the D-OAR is a short and helpful instrument to assess the subjective perception of the nasal appearance in German patients.

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

    PubMed Central

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

    2014-01-01

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

  12. Measuring presenteeism: which questionnaire to use in physical activity research?

    PubMed

    Brown, Helen Elizabeth; Burton, Nicola; Gilson, Nicholas David; Brown, Wendy

    2014-02-01

    An emerging area of interest in workplace health is presenteeism; the measurable extent to which physical or psychosocial symptoms, conditions and disease adversely affect the work productivity of those who choose to remain at work. Given established links between presenteeism and health, and health and physical activity, presenteeism could be an important outcome in workplace physical activity research. This study provides a narrative review of questionnaires for use in such research. Eight self-report measures of presenteeism were identified. Information regarding development, constructs measured and psychometric properties was extracted from relevant articles. Questionnaires were largely self-administered, had 4-44 items, and recall periods ranging from 1 week to 1 year. Items were identified as assessing work performance, physical tolerance, psychological well-being and social or role functioning. Samples used to test questionnaires were predominantly American male employees, with an age range of 30-59 years. All instruments had undergone psychometric assessment, most commonly discriminant and construct validity. Based on instrument characteristics, the range of conceptual foci covered and acceptable measurement properties, the Health and Work Questionnaire, Work Ability Index, and Work Limitations Questionnaire are suggested as most suitable for further exploring the relationship between physical activity and presenteeism.

  13. Patient Reported Outcomes in Preoperative and Postoperative Patients with Hypospadias.

    PubMed

    Keays, Melise A; Starke, Nathan; Lee, Simon C; Bernstein, Ira; Snodgrass, Warren T; Bush, Nicol C

    2016-04-01

    Current outcome tools for hypospadias have limited focus on the caregiver or patient perspective of important patient centered outcomes. In this study we collaborated with patients, caregivers, and lay and medical experts to develop and pilot a patient reported outcome measure for hypospadias. We developed a patient reported outcome measure based on systematic review of the literature and focus group input. The patient reported outcome measure was piloted in caregivers for boys younger than 8 years and in patients older than 8 years who presented for urology consultation before meeting with the surgeon. Patients were classified with uncorrected hypospadias, successful repair or failed repair based on the presence or absence of complications (fistula, diverticulum, meatal stenosis/stricture, greater than 30-degree recurrent curvature, glans dehiscence and/or skin reoperation). A patient reported outcome measure was developed and administered to 347 patients and/or caregivers-proxies, including 105 uncorrected cases, 162 successful repair cases and 80 failed cases. Satisfaction with appearance was highest in those with successful hypospadias repair compared to failed repair and uncorrected hypospadias (93% vs 77% and 67%, respectively). Voiding symptoms such as spraying or a deviated stream were highest in failed and uncorrected cases (39% and 37%, respectively). Overall dissatisfaction with voiding was highest for uncorrected hypospadias and failed repair compared to successful cases (54% and 47%, respectively, vs 15%). The evaluation of patient and caregiver-proxy reported outcomes in preoperative and postoperative patients with hypospadias allows for the quantification of benefits derived from hypospadias repair and may ultimately represent the gold standard outcome measure for hypospadias. This pilot study identified preliminary patient centered themes and demonstrated the feasibility of administering hypospadias patient reported outcome measures in clinical

  14. Outcome instruments to assess scoliosis surgery.

    PubMed

    Bagó, Juan; Climent, Jose Ma; Pérez-Grueso, Francisco J S; Pellisé, Ferran

    2013-03-01

    To review and summarize the current knowledge regarding the outcome measures used to evaluate scoliosis surgery. Literature review. Outcome instruments should be tested to ensure that they have adequate metric characteristics: content and construct validity, reliability, and responsiveness. In the evaluation of scoliosis, generic instruments to assess health-related quality of life (HRQL) have been used, such as the SF-36 questionnaire and the EuroQol5D instrument. Nonetheless, it is preferable to use disease-specific instruments for this purpose, such as the SRS-22 Patient Questionnaire and the quality of life profile for spinal deformities (QLPSD). More recently, these generic and disease-specific instruments have been complemented with the use of super-specific instruments; i.e., those assessing a single aspect of the condition or specific populations with the condition. The patients' perception of their trunk deformity and body image has received particular attention, and several instruments are available to evaluate these aspects, such as the Walter-Reed Visual Assessment Scale (WRVAS), the Spinal Appearance Questionnaire (SAQ), and the Trunk Appearance Perception Scale (TAPS). The impacts of brace use can also be measured with specific scales, including the Bad Sobernheim Stress Questionnaire (BSSQ) and the Brace Questionnaire (BrQ). The available instruments to evaluate the treatment for non-idiopathic scoliosis have not been sufficiently validated and analyzed. Evaluation of scoliosis treatment should include the patient's perspective, which can be obtained with the use of patient-reported outcome measures.

  15. 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

  16. 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.

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

    PubMed

    Arbuckle, Rob; Abetz-Webb, Linda

    2013-01-01

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

  18. Change in patient-reported outcomes in patients with and without mechanical symptoms undergoing arthroscopic meniscal surgery: A prospective cohort study.

    PubMed

    Pihl, Kenneth; Turkiewicz, Aleksandra; Englund, Martin; Stefan Lohmander, L; Jørgensen, Uffe; Nissen, Nis; Schjerning, Jeppe; Thorlund, Jonas B

    2018-05-21

    Patients with degenerative or traumatic meniscal tears are at high risk of developing knee osteoarthritis. We investigated if younger (≤40 years) and older (>40 years) patients with preoperative mechanical symptoms improved more in patient-reported outcomes after meniscal surgery than those without mechanical symptoms. Patients from Knee Arthroscopy Cohort Southern Denmark (KACS) undergoing arthroscopic surgery for a meniscal tear completed online questionnaires before surgery, and at 12 and 52 weeks follow-up. Questionnaires included self-reported presence of mechanical symptoms (i.e. sensation of catching and/or locking) and the Knee Injury and Osteoarthritis Outcome Score (KOOS). We analyzed between-group differences in change in KOOS 4 from baseline to 52 weeks, using an adjusted mixed linear model. 150 younger patients (mean age 31 (SD 7), 67% men) and 491 older patients (mean age 54 (SD 9), 53% men) constituted the baseline cohorts. Patients with mechanical symptoms generally had worse self-reported outcomes before surgery. At 52 weeks follow-up, younger patients with preoperative mechanical symptoms had improved more in KOOS 4 scores than younger patients without preoperative mechanical symptoms (adjusted mean difference 10.5, 95%CI: 4.3, 16.6), but did not exceed the absolute postoperative KOOS 4 scores observed for those without mechanical symptoms. No difference in improvement was observed between older patients with or without mechanical symptoms (adjusted mean difference 0.7, 95%CI: -2.6, 3.9). Younger patients (≤40 years) with preoperative mechanical symptoms experienced greater improvements after arthroscopic surgery compared to younger patients without mechanical symptoms. Our observational study result needs to be confirmed in randomized trials. Copyright © 2018 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  19. Can the painDETECT Questionnaire score and MRI help predict treatment outcome in rheumatoid arthritis: protocol for the Frederiksberg hospital's Rheumatoid Arthritis, pain assessment and Medical Evaluation (FRAME-cohort) study.

    PubMed

    Rifbjerg-Madsen, Signe; Christensen, Anton Wulf; Boesen, Mikael; Christensen, Robin; Danneskiold-Samsøe, Bente; Bliddal, Henning; Bartels, Else Marie; Locht, Henning; Amris, Kirstine

    2014-11-13

    Pain in rheumatoid arthritis (RA) is traditionally considered to be of inflammatory origin. Despite better control of inflammation, some patients still report pain as a significant concern, even when being in clinical remission. This suggests that RA may prompt central sensitisation-one aspect of chronic pain. In contrast, other patients report good treatment response, although imaging shows signs of inflammation, which could indicate a possible enhancement of descending pain inhibitory mechanisms. When assessing disease activity in patients with central sensitisation, the commonly used disease activity scores (eg, DAS28-CRP (C reactive protein)) will yield constant high total scores due to high tender joint count and global health assessments, whereas MRI provides an isolated estimate of inflammation. The objective of this study is, in patients with RA initiating anti-inflammatory treatment, to explore the prognostic value of a screening questionnaire for central sensitisation, hand inflammation assessed by conventional MRI, and the interaction between them regarding treatment outcome evaluated by clinical status (DAS28-CRP). For the purpose of further exploratory analyses, dynamic contrast-enhanced MRI (DCE-MRI) is performed. The painDETECT Questionnaire (PDQ), originally developed to screen for a neuropathic pain component, is applied to indicate the presence of central sensitisation. Adults diagnosed with RA are included when either (A) initiating disease-modifying antirheumatic drug treatment, or (B) initiating or switching to biological therapy. We anticipate that 100 patients will be enrolled, tested and reassessed after 4 months of treatment. Clinical data, conventional MRI, DCE-MRI, blood samples and patient-reported outcomes. This study aims at supporting rheumatologists to define strategies to reach optimal treatment outcomes in patients with RA based on chronic pain prognostics. The study has been approved by The Capital region of Denmark's Ethics

  20. The Challenging Experience Questionnaire: Characterization of challenging experiences with psilocybin mushrooms.

    PubMed

    Barrett, Frederick S; Bradstreet, Matthew P; Leoutsakos, Jeannie-Marie S; Johnson, Matthew W; Griffiths, Roland R

    2016-12-01

    Acute adverse psychological reactions to classic hallucinogens ("bad trips" or "challenging experiences"), while usually benign with proper screening, preparation, and support in controlled settings, remain a safety concern in uncontrolled settings (such as illicit use contexts). Anecdotal and case reports suggest potential adverse acute symptoms including affective (panic, depressed mood), cognitive (confusion, feelings of losing sanity), and somatic (nausea, heart palpitation) symptoms. Responses to items from several hallucinogen-sensitive questionnaires (Hallucinogen Rating Scale, the States of Consciousness Questionnaire, and the Five-Dimensional Altered States of Consciousness questionnaire) in an Internet survey of challenging experiences with the classic hallucinogen psilocybin were used to construct and validate a Challenging Experience Questionnaire. The stand-alone Challenging Experience Questionnaire was then validated in a separate sample. Seven Challenging Experience Questionnaire factors (grief, fear, death, insanity, isolation, physical distress, and paranoia) provide a phenomenological profile of challenging aspects of experiences with psilocybin. Factor scores were associated with difficulty, meaningfulness, spiritual significance, and change in well-being attributed to the challenging experiences. The factor structure did not differ based on gender or prior struggle with anxiety or depression. The Challenging Experience Questionnaire provides a basis for future investigation of predictors and outcomes of challenging experiences with classic hallucinogens. © The Author(s) 2016.

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

    ERIC Educational Resources Information Center

    Weijters, Bert; Geuens, Maggie; Schillewaert, Niels

    2010-01-01

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

  2. 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

  3. An introduction to item response theory for patient-reported outcome measurement.

    PubMed

    Nguyen, Tam H; Han, Hae-Ra; Kim, Miyong T; Chan, Kitty S

    2014-01-01

    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.

  4. The measurement of disability in the elderly: a systematic review of self-reported questionnaires.

    PubMed

    Yang, Ming; Ding, Xiang; Dong, Birong

    2014-02-01

    To analyze the contents and formats of general self-reported questionnaires on disability that are designed for and/or are widely applied in the elderly population to depict a complete picture of this field and help researchers to choose proper tools more efficiently. A broad systematic literature search was performed in September 2013 and included the following databases: MEDLINE, EMBASE, CINAHL, PsycINFO, and PROQOLID. The publication language was limited to English and Chinese. Two review authors independently performed the study selection and data extraction. All of the included instruments were extracted and classified using the International Classification of Functioning, Disability, and Health framework. Of 5569 articles retrieved from the searches and 156 articles retrieved from the pearling, 22 studies (including 24 questionnaires) fulfilled the inclusion criteria. From these, 42 different domains and 458 items were extracted. The most frequently used questionnaire was the Barthel Index followed by the Lawton and Brody Instrumental Activities of Daily Living Scale and the Katz Index of Activities of Daily Living, respectively. The contents and formats of the questionnaires varied considerably. Activities and participation were the most commonly assessed dimensions. In addition, the Activities of Daily Living, mobility and the Instrumental Activities of Daily Living Scale were the most common domains assessed among the included questionnaires. Among the 24 included questionnaires, the most frequently used questionnaires were the Barthel Index, Lawton and Brody Instrumental Activities of Daily Living Scale, and Katz Index of Activities of Daily Living. The content and format of the questionnaires varied considerably, but none of the questionnaires covered all essential dimensions of the International Classification of Functioning, Disability, and Health framework. Copyright © 2014 American Medical Directors Association, Inc. Published by Elsevier Inc. All

  5. 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

  6. Chiropractic chronic low back pain sufferers and self-report assessment methods. Part II. A reliability study of the Middlesex Hospital Questionnaire and the VAS Disability Scales Questionnaire.

    PubMed

    Leboeuf, C; Love, A; Crisp, T C

    1989-04-01

    The subjective complaints of 41 chronic low back pain sufferers attending a chiropractic clinic were assessed twice prior to therapy with a widely used psychological self-report assessment tool, the Middlesex Hospital Questionnaire (MHQ) and a newly developed VAS Disability Scales Questionnaire (DISQ), both of which investigate various aspects of certain basic positions and activities. Reliability was generally acceptable with these two questionnaires. Subjects participating in the study were commonly found to score within the normal range on the MHQ, indicating that psychological disturbance was not a major feature of their presentation. However, mild mood disturbance was commonly reported, and a more sensitive tool may need to be developed for this type of mildly affected chronic low back pain sufferers. The DISQ generally indicated subjects were mildly to moderately affected by their low back trouble and that sitting and leisure activities were the most pain provoking. Recommendations for further development of the disability scale are made.

  7. [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.

  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. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

    PubMed

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

    2014-04-01

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

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

    PubMed

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

    2016-01-01

    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. 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. 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. 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 optimising participation. We highlight the potential for informing

  11. 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

  12. Laparoscopic Heller Myotomy vs Per Oral Endoscopic Myotomy: Patient-Reported Outcomes at a Single Institution.

    PubMed

    Hanna, Andrew N; Datta, Jashodeep; Ginzberg, Sara; Dasher, Kevin; Ginsberg, Gregory G; Dempsey, Daniel T

    2018-04-01

    Although laparoscopic Heller myotomy (LHM) has been the standard of care for achalasia, per oral endoscopic myotomy (POEM) has gained popularity as a viable alternative. This retrospective study aimed to compare patient-reported outcomes between LHM and POEM in a consecutive series of achalasia patients with more than 1 year of follow-up. We reviewed demographic and procedure-related data for patients who underwent either LHM or POEM for achalasia between January 2011 and May 2016. Phone interviews were conducted assessing post-procedure achalasia symptoms via the Eckardt score and achalasia severity questionnaire (ASQ). Demographics, disease factors, and survey results were compared between LHM and POEM patients using univariate analysis. Significant predictors of procedure failure were analyzed using univariate and multivariate analysis. There were no serious complications in 110 consecutive patients who underwent LHM or POEM during the study period, and 96 (87%) patients completed phone surveys. There was a nonsignificant trend toward better patient-reported outcomes with POEM. There were significant differences in patient characteristics including sex, achalasia type, mean residual lower esophageal pressure (rLESP), and follow-up time. The only univariate predictors of an unsatisfactory Eckardt score or ASQ were longer follow-up and lower rLESP, with follow-up length being the only predictor on multivariate analysis. There were significant demographic and clinical differences in patient selection for POEM vs LHM in our group. Although the 2 procedures have similar patient-reported effectiveness, subjective outcomes seem to decline as a result of time rather than procedure type. Copyright © 2018 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  13. Literature review of questionnaires assessing vertigo and dizziness, and their impact on patients' quality of life.

    PubMed

    Duracinsky, Martin; Mosnier, Isabelle; Bouccara, Didier; Sterkers, Olivier; Chassany, Olivier

    2007-01-01

    Vertigo and dizziness, which are major symptoms of diseases affecting the vestibular system, drastically impair patients' health-related quality of life (QoL). Patient's perspectives are thus essential to symptom assessment. We sought to make a critical review of published questionnaires measuring vertigo or dizziness, and/or their impact on QoL. Twenty-nine articles reporting the validation or use in clinical trials of vertigo- or dizziness-specific questionnaires were identified over the 1991-2004 period, and reviewed using a methodological and a Patient-Reported Outcomes specific checklist. Questionnaires were classified into three categories according to content: QoL (or handicap), mixed (assessing both symptoms and QoL), and symptom questionnaires. Four QoL, three mixed questionnaires, two symptoms, and one Meniere's disease-specific questionnaire were identified. QoL questionnaire validation was usually not complete. The structural validity of the Dizziness Handicap Inventory is not established, although this questionnaire is considered to be the reference questionnaire in the QoL domain. Moreover, QoL questionnaires were not very specific to vertigo or dizziness. Similarly, the Vertigo Handicap Questionnaire appeared to have the most pertinent content, but its validation remains to be completed. Mixed questionnaires have the same imperfections. The Vertigo, Dizziness, Imbalance (VDI) Questionnaire had the best validation score from the checklist, but its responsiveness appears to be weak. Regarding symptom questionnaires, the European Evaluation of Vertigo questionnaire evaluated the five major symptoms of vestibular syndrome satisfactorily. The present literature review failed to find any relevant and validated questionnaire assessing the impact of vertigo or dizziness on QoL.

  14. An educational approach to improve outcomes in acute kidney injury (AKI): report of a quality improvement project.

    PubMed

    Xu, Gang; Baines, Richard; Westacott, Rachel; Selby, Nick; Carr, Susan

    2014-03-20

    To assess the impact of a quality improvement project that used a multifaceted educational intervention on how to improve clinician's knowledge, confidence and awareness of acute kidney injury (AKI). 2 large acute teaching hospitals in England, serving a combined population of over 1.5 million people. All secondary care clinicians working in the clinical areas were targeted, with a specific focus on clinicians working in acute admission areas. A multifaceted educational intervention consisting of traditional didactic lectures, case-based teaching in small groups and an interactive web-based learning resource. We assessed clinicians' knowledge of AKI and their self-reported clinical behaviour using an interactive questionnaire before and after the educational intervention. Secondary outcome measures included clinical audit of patient notes before and after the intervention. 26% of clinicians reported that they were aware of local AKI guidelines in the preintervention questionnaire compared to 64% in the follow-up questionnaire (χ²=60.2, p<0.001). There was an improvement in the number of clinicians reporting satisfactory practice when diagnosing AKI, 50% vs 68% (χ²=12.1, p<0.001) and investigating patients with AKI, 48% vs 64% (χ²=9.5, p=0.002). Clinical audit makers showed a trend towards better clinical practice. This quality improvement project utilising a multifaceted educational intervention improved awareness of AKI as demonstrated by changes in the clinician's self-reported management of patients with AKI. Elements of the project have been sustained beyond the project period, and demonstrate the power of quality improvement projects to help initiate changes in practice. Our findings are limited by confounding factors and highlight the need to carry out formal randomised studies to determine the impact of educational initiatives in the clinical setting.

  15. 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

  16. Qualitative and quantitative evaluation of EHR-integrated mobile patient questionnaires regarding usability and cost-efficiency.

    PubMed

    Fritz, Fleur; Balhorn, Sebastian; Riek, Markus; Breil, Bernhard; Dugas, Martin

    2012-05-01

    The objective of this evaluation study is to assess a web-based application, currently available on iPad, to document questionnaires regarding patient reported outcomes such as quality of life. Based on the single source approach, the results of these questionnaires are available in the electronic health record to be used for treatment and research purposes. The assessment focuses on the usability and efficiency of the system. The system usability scale questionnaire with seven additional items was used to rate the usability by the patients. It was formally validated by a Cronbach Alpha test. In addition, semi-structured interviews were conducted with patients and medical staff. Time and cost measures, based on official tables of costs, were taken through workflow observations. This study was conducted in the department of dermatology at the University Hospital of Münster, Germany from April to June 2011. Using the web-based application questionnaire, results about patient reported outcomes like quality of life are immediately available in the electronic health record and can be used for treatment or research purposes. 118 patients and four staff members participated in the study. The usability score reached 80 from 100 points and patients as well as medical staff stated in the interviews that the usability of the web-based system was high, and they preferred it to the previously used paper-based questionnaires. In the setting of our pilot department the mobile devices amortized their costs after 6.7 months. In general, depending on the professional group who are going to post process the paper-based forms, the earliest break-even point to use mobile questionnaires is at 1737 paper sheets per year. The mobile patient questionnaires, integrated into the electronic health record, were well accepted in our pilot setting with high usability scores from patients and medical staff alike. The system has also proved to be cost-efficient compared to the paper

  17. Measurement properties of questionnaires assessing participation in children and adolescents with a disability: a systematic review.

    PubMed

    Rainey, Linda; van Nispen, Ruth; van der Zee, Carlijn; van Rens, Ger

    2014-12-01

    To critically appraise the measurement properties of questionnaires measuring participation in children and adolescents (0-18 years) with a disability. Bibliographic databases were searched for studies evaluating the measurement properties of self-report or parent-report questionnaires measuring participation in children and adolescents (0-18 years) with a disability. The methodological quality of the included studies and the results of the measurement properties were evaluated using a checklist developed on consensus-based standards. The search strategy identified 3,977 unique publications, of which 22 were selected; these articles evaluated the development and measurement properties of eight different questionnaires. The Child and Adolescent Scale of Participation was evaluated most extensively, generally showing moderate positive results on content validity, internal consistency, reliability and construct validity. The remaining questionnaires also demonstrated positive results. However, at least 50 % of the measurement properties per questionnaire were not (or only poorly) assessed. Studies of high methodological quality, using modern statistical methods, are needed to accurately assess the measurement properties of currently available questionnaires. Moreover, consensus is required on the definition of the construct 'participation' to determine content validity and to enable meaningful interpretation of outcomes.

  18. Effectiveness of a Medical vs Revascularization Intervention for Intermittent Leg Claudication Based on Patient-Reported Outcomes.

    PubMed

    Devine, Emily B; Alfonso-Cristancho, Rafael; Yanez, N David; Edwards, Todd C; Patrick, Donald L; Armstrong, Cheryl A L; Devlin, Allison; Symons, Rebecca G; Meissner, Mark H; Derrick, Ellen L T; Lavallee, Danielle C; Kessler, Larry G; Flum, David R

    2016-10-19

    Intermittent claudication (IC) is the most common presentation of infrainguinal peripheral artery disease. Both medical and revascularization interventions for IC aim to increase walking comfort and distance, but there is inconclusive evidence of the comparative benefit of revascularization given the possible risk of limb loss. To compare the effectiveness of a medical (walking program, smoking cessation counseling, and medications) vs revascularization (endovascular or surgical) intervention for IC in the community, focusing on outcomes of greatest importance to patients. Longitudinal (12-month follow-up) prospective observational cohort study conducted between July 3, 2011, and November 5, 2014, at 15 clinics associated with 11 hospitals in Washington State. Participants were 21 years or older with newly diagnosed or established IC. Medical or revascularization interventions. Primary end points were 12-month change scores on the distance, speed, and stair-climb domains of the Walking Impairment Questionnaire (score range, 0-100). Secondary outcomes were change scores on the Walking Impairment Questionnaire pain domain (score range, 0-100), Vascular Quality of Life Questionnaire (VascuQol) (score range, 1-7), European Quality of Life-5 Dimension Questionnaire (EQ-5D) (score range, 0-1), and Claudication Symptom Instrument (CSI) (score range, 0-4). A total of 323 adults were enrolled, with 282 (87.3%) in the medical cohort. At baseline, the mean duration of disease was longer for participants in the medical cohort, while those in the revascularization cohort reported more severe disease. Other characteristics were well balanced. At 12 months, change scores in the medical cohort reached significance for the following 3 outcomes: speed (5.9; 95% CI, 0.5-11.3; P = .03), VascuQol (0.28; 95% CI, 0.08-0.49; P = .008), and EQ-5D (0.038; 95% CI, 0.011-0.066; P = .006). In the revascularization cohort, there were significant improvements in the following 7

  19. Advance telephone calls ahead of reminder questionnaires increase response rate in non-responders compared to questionnaire reminders only: The RECORD phone trial.

    PubMed

    MacLennan, Graeme; McDonald, Alison; McPherson, Gladys; Treweek, Shaun; Avenell, Alison

    2014-01-08

    Postal questionnaires are simple and economical for collecting outcome data for randomised controlled trials (RCTs) but are prone to non-response. In the RECORD trial (a large pragmatic publicly funded RCT in UK) non-responders were sent a reminder and another questionnaire at 1 year, of which 40% were returned. In subsequent years we investigated the effect of an advance telephone call to non-responders on responses rate to reminder questionnaires and the next questionnaire 4 months later. Non-responders to annual questionnaires were randomised to receive a telephone call from the trial office ahead of the reminder questionnaire in addition to the usual reminder schedule (n=390) or to a control group that received the usual reminder schedule only (n=363). The primary outcome was response to the reminder questionnaire within 21 days; secondary outcomes were response to a questionnaire 4 months later; completeness of quality of life instruments; and the number of participants declining further follow-up. Results are presented as odds ratios from a logistic regression intention-to-treat (ITT) analysis and then percentage difference and 95% confidence intervals (CI) for both ITT and average treatment effect on the treated (ATT) analyses. The proportions that responded were 67.8% (265/390) in the intervention group compared to 62.5% (227/363) in the control group. The ITT estimate was a 5.4% increase (95% CI -1.4 to 12.2). Four months later percentages responding were 51.8% (202) and 42.7% (155). The ITT estimate was a 9.1% increase (95% CI 2.0 to 16.2). In the intervention group 12.3% (48/390) of participants were not telephoned because questionnaires were returned before the scheduled telephone call. ATT estimates adjusting for this were 6.2% (95% CI -1.6 to 14.0) and 10.4% (95% CI 2.2 to 18.5), respectively. The telephone call resulted in a slight increase in response to the reminder questionnaire, however at 4 months later the proportion in the telephoned group

  20. Development and Validation of an Abbreviated Questionnaire to Easily Measure Cognitive Failure in ICU Survivors: A Multicenter Study.

    PubMed

    Wassenaar, Annelies; de Reus, Jorn; Donders, A Rogier T; Schoonhoven, Lisette; Cremer, Olaf L; de Lange, Dylan W; van Dijk, Diederik; Slooter, Arjen J C; Pickkers, Peter; van den Boogaard, Mark

    2018-01-01

    To develop and validate an abbreviated version of the Cognitive Failure Questionnaire that can be used by patients as part of self-assessment to measure functional cognitive outcome in ICU survivors. A retrospective multicenter observational study. The ICUs of two Dutch university hospitals. Adult ICU survivors. None. Cognitive functioning was evaluated between 12 and 24 months after ICU discharge using the full 25-item Cognitive Failure Questionnaire (CFQ-25). Incomplete CFQ-25 questionnaires were excluded from analysis. Forward selection in a linear regression model was used in hospital A to assess which of the CFQ-25 items should be included to prevent a significant loss of correlation between an abbreviated and the full CFQ-25. Subsequently, the performance of an abbreviated Cognitive Failure Questionnaire was determined in hospital B using Pearson's correlation. A Bland-Altman plot was used to examine whether the reduced-item outcome scores of an abbreviated Cognitive Failure Questionnaire were a replacement for the full CFQ-25 outcome scores. Among 1,934 ICU survivors, 1,737 were included, 819 in hospital A, 918 in hospital B. The Pearson's correlation between the abbreviated 14-item Cognitive Failure Questionnaire (CFQ-14) and the CFQ-25 was 0.99. The mean of the difference scores was -0.26, and 95% of the difference scores fell within +5 and -5.5 on a 100-point maximum score. It is feasible to use the abbreviated CFQ-14 to measure self-reported cognitive failure in ICU survivors as this questionnaire has a similar performance as the full CFQ-25.

  1. [Validation of the Spanish parent satisfaction questionnaire with neonatal hearing screening programs].

    PubMed

    Núñez-Batalla, Faustino; Antuña-León, Eva; González-Trelles, Teresa; Carro-Fernández, Pilar

    2009-01-01

    Although measuring parent satisfaction has been recommended as one of the important outcome measures in assessing the effectiveness of neonatal hearing screening programs, there are few published studies investigating this issue. To validate the Spanish version of the Parent Satisfaction Questionnaire with Neonatal Hearing Screening Program (PSQ-NHSP). 112 parents whose children had received hearing screening participated in this study. High levels of satisfaction were reported with more than 90% of parents satisfied with all aspects of the program. The psychometric properties of the Spanish version of the PSQ-NHSP were analyzed and demonstrated good internal consistency (alpha=0.75). Construct validity was indicated by a significant positive relationship between overall satisfaction and the three specific dimensions in the questionnaire. The development of a valid and reliable parent satisfaction questionnaire is important for improving hearing screening programs.

  2. Swallowing in the first year after chemoradiotherapy for head and neck cancer: clinician- and patient-reported outcomes.

    PubMed

    Patterson, Joanne M; McColl, Elaine; Carding, Paul N; Hildreth, Anthony J; Kelly, Charles; Wilson, Janet A

    2014-03-01

    This prospective study evaluated swallowing outcomes prechemoradiotherapy (pre-CRT) up to 1 year post-CRT, in a substantial cohort of patients with head and neck cancer and explored factors predicting outcome. One hundred twelve patients were assessed pretreatment and at 3, 6, and 12 months posttreatment using a questionnaire, endoscopic assessment, water swallow test, and diet score. Seventy-one patients were retained, the majority had oropharyngeal (53%) or hypopharyngeal cancer (20%). A marked deterioration occurred between pretreatment and 3 months posttreatment (p ≤ .01). Significant improvement between 3 and 12 months was found on 2 swallowing measures, but not self reported. Three of the 4 pretreatment assessments predicted outcomes at 1 year. CRT results in a marked deterioration on different paradigms of swallowing measurements. Improvement occurs on some clinical measures, but limited change is observed in patients' perceptions. Pretreatment measures are important indicators of long-term dysphagia. Swallowing recovery is complex, taking different courses between clinical tests and perspectives. Copyright © 2013 Wiley Periodicals, Inc., A Wiley Company.

  3. Spanish Adaptation and Validation of the Outcome Questionnaire OQ-30.2

    PubMed Central

    Errázuriz, Paula; Opazo, Sebastián; Behn, Alex; Silva, Oscar; Gloger, Sergio

    2017-01-01

    This study assessed the psychometric properties of a Spanish version of the Shortened Outcome Questionnaire (OQ-30.2, Lambert et al., 2004) validated with a sample of 546 patients in an outpatient mental health clinic and 100 non-clinical adults in Chile. Our results show that this measure has similar normative data to the original measure, with a cutoff score for the Chilean population set at 43.36, and the reliable change index at 14. This Spanish OQ-30.2 has good internal consistency (α = 0.90), has concurrent validity with the Depressive, Anxious, and Somatoform disorders measuring scale (Alvarado and Vera, 1991), and is sensitive to change during psychotherapy. Consistent with previous studies, factorial analyses showed that both, the one-factor solution for a general scale and the three-factor solution containing three theoretical scales yielded poor fit estimates. Overall, our results are similar to past research on the OQ-45 and the OQ-30. The short version has adequate psychometric properties, comparable to those of the OQ-45, but provides a gain in application time that could be relevant in the setting of psychotherapy research with large samples, frequent assessments over time, and/or samples that may require more assistance completing items (e.g., low-literacy). We conclude that this measure will be a valuable instrument for research and clinical practice. PMID:28559857

  4. Outcomes and Disability After Massive Proximal Upper Extremity Reconstruction in a Resource-Limited Setting.

    PubMed

    Giladi, Aviram M; Shanmugakrishnan, R Raja; Venkatramani, Hari; Raja Sekaran, S; Chung, Kevin C; Sabapathy, S Raja

    2017-06-01

    At Ganga Hospital in Coimbatore, India, a unique approach is applied to treat massive upper limb injuries. However, long-term outcomes of complex reconstruction performed in the resource-limited setting are not known. This hinders understanding of outcomes and disability from these injuries and prevents systematically addressing care delivery around upper extremity trauma in the developing world. This project aims to analyze the details of the unique Ganga Hospital reconstruction experience and use patient-reported outcome measures for the first time in this patient population to evaluate post-injury recovery and disability . Forty-six patients were evaluated 6 months or more after massive proximal upper extremity reconstruction at Ganga Hospital. Patients completed functional tests, Jebsen-Taylor test (JTT), and patient-reported outcomes (PROs)-Michigan Hand Questionnaire (MHQ), Disability of Arm, Shoulder, and Hand questionnaire (DASH), and Short-Form 36 (SF-36). Correlations between metrics were assessed with Pearson's correlation coefficients. Linear regression modeling evaluated associations between severity, reconstruction, and outcomes. MHQ and DASH results correlated with functional test performance, JTT performance, and SF-36 scores (Pearson's coefficients all ≥0.33, p ≤ 0.05). In this cohort, mean MHQ score was 79 ± 15 and mean DASH score was 13 ± 15, which are not significantly different than scores for long-term outcomes after other complex upper extremity procedures. The following factors predicted PROs and functional performance after reconstruction: extent of soft tissue reconstruction, multi-segmental ulna fractures, median nerve injury, and ability for patients to return to work and maintain their job after injury. Complex proximal upper extremity salvage can be performed in the resource-limited setting with excellent long-term functional and patient-reported outcomes. PRO questionnaires are useful for reporting outcomes that correlate

  5. The Subthreshold Autism Trait Questionnaire (SATQ): Development of a Brief Self-Report Measure of Subthreshold Autism Traits

    ERIC Educational Resources Information Center

    Kanne, Stephen M.; Wang, Jennifer; Christ, Shawn E.

    2012-01-01

    The current study was motivated by a need for a self-report questionnaire that assesses a broad range of subthreshold autism traits, is brief and easily administered, and is relevant to the general population. An initial item pool was administered to 1,709 students. Structural validity analysis resulted in a 24-item questionnaire termed the…

  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. Improving Outcomes in Patients with CRC: The Role of Patient Reported Outcomes—An ESDO Report

    PubMed Central

    Van Cutsem, Eric; De Gramont, Aimery; Henning, Geoffrey; Rougier, Philippe; Bonnetain, Franck; Seufferlein, Thomas

    2017-01-01

    Colorectal cancer is one of the most commonly diagnosed cancers worldwide and nearly half of patients will develop metastatic disease at some point during the course of their disease. The goal of anticancer therapy in this context is to extend survival, while trying to maximise the patient’s health-related quality of life. To this end, we need to understand how to incorporate patient-reported outcomes into clinical trials and routine practice to accurately assess if treatment strategies are providing clinical benefit for the patient. This review reflects the proceedings of a 2016 European Society of Digestive Oncology workshop, where the authors discussed the use of patient-reported outcomes to measure health-related quality of life when evaluating treatment during the management of colorectal cancer. A summary of the challenges associated with implementing patient-reported outcomes in clinical trials is provided, as well as a review of the current clinical evidence surrounding patient-reported outcomes in metastatic colorectal cancer. PMID:28587143

  8. Student Outcomes in Inquiry: Students' Perspectives

    ERIC Educational Resources Information Center

    Saunders-Stewart, K. S.; Gyles, P. D. T.; Shore, B. M.; Bracewell, R. J.

    2015-01-01

    Student outcomes of inquiry-based teaching and learning were explored through student-report. Participants were six teachers and their 181 students in grades 9 through 12. Classes were categorized by level of inquiry (least, middle, and most). A student-administered questionnaire assessed the extent to which the three groups experienced 23…

  9. The prediction of poor outcome in young adults: comparison of the Young Adult Self-Report, the General Health Questionnaire and the Symptom Checklist.

    PubMed

    Ferdinand, R F; Verhulst, F C

    1994-06-01

    The ability of the Young Adult Self-Report (YASR), the Symptom Checklist (SCL-90) and the General Health Questionnaire (GHQ-28) to predict maladjustment across a 2-year time-span was assessed in a general population sample of 528 18- to 22-year-olds. Referral for mental health services and need for professional help were predicted by total problem scores of the YASR, the GHQ-28 and the SCL-90 and by the internalizing scale of the YASR. Furthermore, the internalizing scale predicted suicide attempts or suicidal ideation, whereas the externalizing scale predicted police contacts. The YASR delinquent behavior syndrome was the only significant predictor of alcohol abuse. The findings supported the validity of the YASR as an instrument for the assessment of psychopathology in young adults.

  10. Patient-reported outcomes in a large community-based pain medicine practice: evaluation for use in phenotype modeling.

    PubMed

    Juckett, David A; Davis, Fred N; Gostine, Mark; Reed, Philip; Risko, Rebecca

    2015-05-28

    An academic, community medicine partnership was established to build a phenotype-to-outcome model targeting chronic pain. This model will be used to drive clinical decision support for pain medicine in the community setting. The first step in this effort is an examination of the electronic health records (EHR) from clinics that treat chronic pain. The biopsychosocial components provided by both patients and care providers must be of sufficient scope to populate the spectrum of patient types, treatment modalities, and possible outcomes. The patient health records from a large Midwest pain medicine practice (Michigan Pain Consultants, PC) contains physician notes, administrative codes, and patient-reported outcomes (PRO) on over 30,000 patients during the study period spanning 2010 to mid-2014. The PRO consists of a regularly administered Pain Health Assessment (PHA), a biopsychosocial, demographic, and symptomology questionnaire containing 163 items, which is completed approximately every six months with a compliance rate of over 95%. The biopsychosocial items (74 items with Likert scales of 0-10) were examined by exploratory factor analysis and descriptive statistics to determine the number of independent constructs available for phenotypes and outcomes. Pain outcomes were examined both in the aggregate and the mean of longitudinal changes in each patient. Exploratory factor analysis of the intake PHA revealed 15 orthogonal factors representing pain levels; physical, social, and emotional functions; the effects of pain on these functions; vitality and health; and measures of outcomes and satisfaction. Seven items were independent of the factors, offering unique information. As an exemplar of outcomes from the follow-up PHAs, patients reported approximately 60% relief in their pain. When examined in the aggregate, patients showed both a decrease in pain levels and an increase in coping skills with an increased number of visits. When examined individually, 80-85% of

  11. The validity of health-related quality of life questionnaires in bronchiectasis: a systematic review and meta-analysis.

    PubMed

    Spinou, Arietta; Fragkos, Konstantinos C; Lee, Kai K; Elston, Caroline; Siegert, Richard J; Loebinger, Michael R; Wilson, Robert; Garrod, Rachel; Birring, Surinder S

    2016-08-01

    A range of questionnaires have been used to assess health-related quality of life (HRQOL) in bronchiectasis. A systematic review was conducted to evaluate their psychometric properties and assess associations between HRQOL and clinical measures. Five electronic databases were searched. Studies eligible for inclusion were those that investigated the validity of HRQOL questionnaires and/or their association with other outcomes in adults with bronchiectasis. Patients with cystic fibrosis were excluded. The identified questionnaires were assessed for convergent, discriminant and cross-cultural translation validity; missing data, floor and ceiling effects, internal consistency, responsiveness and test-retest reliability. A meta-analysis was conducted to estimate the strength of associations between HRQOL and clinical measures. From 1918 studies identified, 43 studies were included in the systematic review, of which 38 were suitable for the meta-analysis. Nine HRQOL questionnaires were identified, with the most widely used being: St George's Respiratory Questionnaire, Leicester Cough Questionnaire, Quality of Life-Bronchiectasis and Short Form-36. HRQOL questionnaires had moderate to good internal consistency and good test-retest reliability. Only 8 of 18 studies that used translated HRQOL questionnaires reported or referred to the validity of the translated questionnaire. There was a stronger correlation (mean r (95% CI)) between HRQOL and subjective outcome measures, such as dyspnoea (0.55 (0.41 to 0.68)) and fatigue (0.42 (0.23 to 0.58)) compared with objective measures; exercise capacity (-0.41 (-0.54 to -0.24)), FEV1% predicted (-0.31 (-0.40 to -0.23)) and extent of bronchiectasis on CT scan (0.35 (0.03 to 0.61)); all p<0.001. This review supports most HRQOL questionnaires used in bronchiectasis have good psychometric properties. There was a weak to moderate association between HRQOL and objective outcome measures. This suggests that HRQOL questionnaires assess a

  12. The Need for Core Outcome Reporting in Autologous Fat Grafting for Breast Reconstruction.

    PubMed

    Agha, Riaz A; Fowler, Alexander J; Pidgeon, Thomas E; Wellstead, Georgina; Orgill, Dennis P

    2016-11-01

    There is growing interest in autologous fat grafting (AFG) for breast reconstruction. This systematic review examines the range of outcomes used across studies of AFG, their definitions and whether there is a need for a core outcome set to aid reporting. Following the protocol of our systematic review, a search of 20 databases (1986 to March 2014) returned 35 studies which met the inclusion criteria. These were assessed independently by two authors. Disagreements were resolved by consensus. Of the 35 studies, 27 (77%) were case series, 5 (14.3%) were cohort studies, and 3 (8.6%) were case reports. A total of 51 different outcomes were reported. These studies each reported a median of five separate outcomes (range, 2-14), of which a median of 3 outcomes were defined (range, 0-14). A median of 2 outcomes per paper were prespecified in the study methods (range, 0-12) and a median of only 2 outcomes per paper (range, 0-12) were both defined and prespecified. The most commonly reported outcome in studies of AFG was that of "operative details," reported by 26 studies, and eight different outcome definitions were used. "Cancer recurrence" was reported by 20 studies, with the use of 10 different outcome definitions. Overall, there was a poor proportion of defined and prespecified outcomes that employed a wide range of different outcome definitions. In addition only 14/35 studies stated the number of patients lost to follow-up. There is a need for a core outcomes set for AFG to the breast to minimise outcome and reporting bias and aid evidence synthesis. Our future research will focus in this direction, titled VOGUE or Valid Outcomes for the Grafting of AUtologous Fat to the BrEast study. We invite all those interested to get in touch with the lead author.

  13. Treatment Satisfaction in Systemic Lupus Erythematosus: Development of a Patient-Reported Outcome Measure.

    PubMed

    Mathias, Susan D; Berry, Pamela; Pascoe, Katie; de Vries, Jane; Askanase, Anca D; Colwell, Hilary H; Chang, David J

    2017-03-01

    The aim of this study was to develop a patient-reported outcome measure specific for systemic lupus erythematosus (SLE) to assess patient satisfaction with treatment, treatment options, and medical care. Patients with SLE were recruited from four US rheumatology practices. Concept elicitation interviews identified aspects that patients considered important and relevant regarding satisfaction with treatment and medical care. Concept elicitation interviews and clinical input were used to draft the Lupus Satisfaction Questionnaire (LSQ). A second cohort of patients with SLE participated in combined concept elicitation/cognitive debriefing interviews, after which the LSQ was revised. Fourteen patients completed concept elicitation interviews: 93% were female, 57% were white, and 85% had moderate/severe SLE. Current treatments included hydroxychloroquine (93%), steroids (79%), and belimumab (57%), and 43% were biologic naive. Patients were generally satisfied with their treatment and medical care; however, they were dissatisfied with treatment adverse effects and the number of available treatment options. Cognitive debriefing interviews (n = 8) demonstrated that the LSQ was comprehensive, clear, and relevant; therefore, only minor revisions were made to the questionnaire. The LSQ assesses satisfaction with current SLE treatments (25 items), medical care (11 items), and insurance coverage (3 items). The draft LSQ was evaluated in 195 adults with SLE. Fifty-eight percent of patients reported that they were "somewhat satisfied" with their SLE treatment. The LSQ has been developed to assess treatment satisfaction among patients with SLE. Following further testing to support its validity and reliability, it will provide a useful tool to facilitate assessment of satisfaction with treatments for SLE and help inform treatment decisions.

  14. Validation of a Self-Report Questionnaire Assessing the Bodily and Physiological Sensations of Orgasm.

    PubMed

    Dubray, Samantha; Gérard, Marina; Beaulieu-Prévost, Dominic; Courtois, Frédérique

    2017-02-01

    Despite a plethora of research on sexual functioning during the past decades, the field is still lacking standardized measurements specifically characterizing orgasm. Although several validated tools are available to assess sexual function in healthy and clinical populations, items on orgasm are limited to frequency or dichotomous responses. A neurophysiologic model of orgasm developed from previous research in able-bodied and spinally injured populations offers a promising framework for the construction of a new questionnaire. To develop and validate a brief self-report measurement of orgasm by the assessment of bodily and physiologic sensations perceived during climax by able-bodied individuals. Although the currently available tool focuses on the phenomenological sensations associated with climax, the goal of this questionnaire was to capture the more specific genital and extragenital sensations associated with orgasm. The current Bodily Sensations of Orgasm questionnaire and the Orgasm Rating Scale. Data from previous research conducted on individuals with spinal cord injury and the available empirical literature provided a pool of 45 items organized into four categories, which were reviewed by an expert panel. Upon review, a 28-item questionnaire was created and administered to a community sample of 227 participants, including men and women, 18 to 73 years old. Exploratory factor analyses supported the four-factor model, in which orgasm is comprised of extragenital sensations, genital sensations and spasms, nociceptive sensations, and sweating responses. Overall, a high degree of internal consistency was found for the final 22-item questionnaire (Cronbach α = 0.87), with individual reliability coefficients showing moderate to high internal consistency (r = 0.65-0.79) for each dimension. Overall temporal stability of the measurement was acceptable (r = 0.74). Using the Orgasm Rating Scale, satisfying convergent validity was confirmed, thereby indicating

  15. Expectancies, socioeconomic status, and self-rated health: use of the simplified TOMCATS Questionnaire.

    PubMed

    Odéen, Magnus; Westerlund, Hugo; Theorell, Töres; Leineweber, Constanze; Eriksen, Hege R; Ursin, Holger

    2013-06-01

    Coping has traditionally been measured with inventories containing many items meant to identify specific coping strategies. An alternative is to develop a shorter inventory that focusses on coping expectancies which may determine the extent to which an individual attempts to cope actively. This paper explores the usefulness and validity of a simplified seven-item questionnaire (Theoretically Originated Measure of the Cognitive Activation Theory of Stress, TOMCATS) for response outcome expectancies defined either as positive ("coping"), negative ("hopelessness"), or none ("helplessness"). The definitions are based on the Cognitive Activation Theory of Stress (CATS; Ursin and Eriksen, Psychoneuroendocrinology, 29(5):567–92, 2004). The questionnaire was tested in two different samples. First, the questionnaire was compared with a traditional test of coping and then tested for validity in relation to socioeconomic differences in self-reported health. The first study was a comparison of the brief TOMCATS with a short version of the Utrecht Coping List (UCL; Eriksen et al., Scand J Psychol, 38(3):175–82, 1997). Both questionnaires were tested in a population of 1,704 Norwegian municipality workers. The second study was a cross-sectional analysis of TOMCATS, subjective and objective socioeconomic status, and health in a representative sample of the Swedish working population in 2003–2005 (N = 11,441). In the first study, the coping item in the TOMCATS questionnaire showed an expected significant positive correlation with the UCL factors of instrumental mastery-oriented coping and negative correlations with passive and depressive scores. There were also the expected correlations for the helplessness and hopelessness scores, but there was no clear distinction between helplessness and hopelessness in the way they correlated with the UCL. In the second study, the coping item in TOMCATS and the three-item helplessness scores showed clear and monotonous gradients over

  16. 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…

  17. Navigation-assisted versus conventional total knee replacement: no difference in patient-reported outcome measures (PROMs) at 1 and 2 years.

    PubMed

    Singisetti, Kiran; Muthumayandi, Karthikeyan; Abual-Rub, Zaid; Weir, David

    2015-11-01

    Navigation technique for total knee replacement has been shown to improve accuracy of prosthesis alignment in several studies. The purpose was to compare the patient-reported outcome measures in primary total knee replacement (TKR) using navigation versus conventional surgical technique at 1- and 2-year follow-up. A retrospective review of prospectively collected patient-reported outcome data for 351 consecutively performed primary TKR was included in the study. The study group (N = 113) included patients who had Triathlon TKR using articular surface mounted (ASM Stryker) navigation technique and control group (N = 238) included patients who had Triathlon TKR using conventional jig. In addition to the WOMAC (Western Ontario and McMaster University Osteoarthritis Index) and SF-36 (Medical Outcomes Trust Short Form-36), a short self-report questionnaire evaluating the level of satisfaction, quality of life and whether patients would undergo knee replacement again. WOMAC: no significant difference between the groups was noted in mean WOMAC pain, function and stiffness scores at 1- and 2-year follow-up. SF-36: no significant difference between the groups was seen except in the physical function component of score at 1 year (p = 0.019). Navigation group mean 56.78 (CI 51.06-62.5) versus conventional group mean 48.34 (44.68-52.01) but this difference was not observed at 2-year follow-up. The overall patient-reported outcome scores improved after total knee replacement but appear to be comparable in both groups at 1- and 2-year follow-up.

  18. Alternatives to Traditional EMS Dispatch and Transport: A Scoping Review of Reported Outcomes.

    PubMed

    Jensen, Jan L; Carter, Alix J E; Rose, Jennifer; Visintini, Sarah; Bourdon, Emmanuelle; Brown, Ryan; McVey, Jennifer; Travers, Andrew H

    2015-09-01

    Emergency medical services (EMS) programs, which provide an alternative to traditional EMS dispatch or transport to the emergency department (ED), are becoming widely implemented. This scoping review identified and catalogued all outcomes used to measure such alternative EMS programs. Data Source Broad systematized bibliographic and grey literature searches were conducted. Study Selection Inclusion criteria were 911 callers/EMS patients, reported on alternatives to traditional EMS dispatch OR traditional EMS transport to the ED, and reported an outcome measure. Data Extraction The reports were categorized as either alternative to dispatch or to EMS transport, and outcome measures were categorized and described. Data Synthesis The bibliographic search retrieved 13,215 records, of which 34 articles met the inclusion criteria, with an additional 10 added from reference list hand-searching (n=44 included). In the grey literature search, 31 websites were identified, from which four met criteria and were retrieved (n=4 included). Fifteen reports (16 studies) described alternatives to EMS dispatch, and 33 reports described alternatives to EMS transport. The most common outcomes reported in the alternatives to EMS dispatch reports were service utilization and decision accuracy. Twenty-four different specific outcomes were reported. The most common outcomes reported in the alternatives to EMS transport reports were service utilization and safety, and 50 different specific outcomes were reported. Numerous outcome measures were identified in reports of alternative EMS programs, which were catalogued and described. Researchers and program leaders should achieve consensus on uniform outcome measures, to allow benchmarking and improve comparison across programs.

  19. High Variability in Outcome Reporting Patterns in High-Impact ACL Literature.

    PubMed

    Makhni, Eric C; Padaki, Ajay S; Petridis, Petros D; Steinhaus, Michael E; Ahmad, Christopher S; Cole, Brian J; Bach, Bernard R

    2015-09-16

    ACL (anterior cruciate ligament) reconstruction is one of the most commonly performed and studied procedures in modern sports medicine. A multitude of objective and subjective patient outcome measures exists; however, nonstandardized reporting patterns of these metrics may create challenges in objectively analyzing pooled results from different studies. The goal of this study was to document the variability in outcome reporting patterns in high-impact orthopaedic studies of ACL reconstruction. All clinical studies pertaining to ACL reconstruction in four high-impact-factor orthopaedic journals over a five-year period were reviewed. Biomechanical, basic science, and imaging studies were excluded, as were studies with fewer than fifty patients, yielding 119 studies for review. Incorporation of various objective and subjective outcomes was noted for each study. Substantial variability in reporting of both objective and subjective measures was noted in the study cohort. Although a majority of studies reported instrumented laxity findings, there was substantial variability in the type and method of laxity reporting. Most other objective outcomes, including range of motion, strength, and complications, were reported in <50% of all studies. Return to pre-injury level of activity was infrequently reported (24% of studies), as were patient satisfaction and pain assessment following surgery (8% and 13%, respectively). Of the patient-reported outcomes, the International Knee Documentation Committee (IKDC), Lysholm, and Tegner scores were most often reported (71%, 63%, and 42%, respectively). Substantial variability in outcome reporting patterns exists among high-impact studies of ACL reconstruction. Such variability may create challenges in interpreting results and pooling them across different studies. Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.

  20. Electronic versus paper-based assessment of health-related quality of life specific to HIV disease: reliability study of the PROQOL-HIV questionnaire.

    PubMed

    Duracinsky, Martin; Lalanne, Christophe; Goujard, Cécile; Herrmann, Susan; Cheung-Lung, Christian; Brosseau, Jean-Paul; Schwartz, Yannick; Chassany, Olivier

    2014-04-25

    Electronic patient-reported outcomes (PRO) provide quick and usually reliable assessments of patients' health-related quality of life (HRQL). An electronic version of the Patient-Reported Outcomes Quality of Life-human immunodeficiency virus (PROQOL-HIV) questionnaire was developed, and its face validity and reliability were assessed using standard psychometric methods. A sample of 80 French outpatients (66% male, 52/79; mean age 46.7 years, SD 10.9) were recruited. Paper-based and electronic questionnaires were completed in a randomized crossover design (2-7 day interval). Biomedical data were collected. Questionnaire version and order effects were tested on full-scale scores in a 2-way ANOVA with patients as random effects. Test-retest reliability was evaluated using Pearson and intraclass correlation coefficients (ICC, with 95% confidence interval) for each dimension. Usability testing was carried out from patients' survey reports, specifically, general satisfaction, ease of completion, quality and clarity of user interface, and motivation to participate in follow-up PROQOL-HIV electronic assessments. Questionnaire version and administration order effects (N=59 complete cases) were not significant at the 5% level, and no interaction was found between these 2 factors (P=.94). Reliability indexes were acceptable, with Pearson correlations greater than .7 and ICCs ranging from .708 to .939; scores were not statistically different between the two versions. A total of 63 (79%) complete patients' survey reports were available, and 55% of patients (30/55) reported being satisfied and interested in electronic assessment of their HRQL in clinical follow-up. Individual ratings of PROQOL-HIV user interface (85%-100% of positive responses) confirmed user interface clarity and usability. The electronic PROQOL-HIV introduces minor modifications to the original paper-based version, following International Society for Pharmacoeconomics and Outcomes Research (ISPOR) ePRO Task

  1. Electronic Versus Paper-Based Assessment of Health-Related Quality of Life Specific to HIV Disease: Reliability Study of the PROQOL-HIV Questionnaire

    PubMed Central

    Lalanne, Christophe; Goujard, Cécile; Herrmann, Susan; Cheung-Lung, Christian; Brosseau, Jean-Paul; Schwartz, Yannick; Chassany, Olivier

    2014-01-01

    Background Electronic patient-reported outcomes (PRO) provide quick and usually reliable assessments of patients’ health-related quality of life (HRQL). Objective An electronic version of the Patient-Reported Outcomes Quality of Life-human immunodeficiency virus (PROQOL-HIV) questionnaire was developed, and its face validity and reliability were assessed using standard psychometric methods. Methods A sample of 80 French outpatients (66% male, 52/79; mean age 46.7 years, SD 10.9) were recruited. Paper-based and electronic questionnaires were completed in a randomized crossover design (2-7 day interval). Biomedical data were collected. Questionnaire version and order effects were tested on full-scale scores in a 2-way ANOVA with patients as random effects. Test-retest reliability was evaluated using Pearson and intraclass correlation coefficients (ICC, with 95% confidence interval) for each dimension. Usability testing was carried out from patients’ survey reports, specifically, general satisfaction, ease of completion, quality and clarity of user interface, and motivation to participate in follow-up PROQOL-HIV electronic assessments. Results Questionnaire version and administration order effects (N=59 complete cases) were not significant at the 5% level, and no interaction was found between these 2 factors (P=.94). Reliability indexes were acceptable, with Pearson correlations greater than .7 and ICCs ranging from .708 to .939; scores were not statistically different between the two versions. A total of 63 (79%) complete patients’ survey reports were available, and 55% of patients (30/55) reported being satisfied and interested in electronic assessment of their HRQL in clinical follow-up. Individual ratings of PROQOL-HIV user interface (85%-100% of positive responses) confirmed user interface clarity and usability. Conclusions The electronic PROQOL-HIV introduces minor modifications to the original paper-based version, following International Society for

  2. Selective outcome reporting and sponsorship in randomized controlled trials in IVF and ICSI.

    PubMed

    Braakhekke, M; Scholten, I; Mol, F; Limpens, J; Mol, B W; van der Veen, F

    2017-10-01

    Are randomized controlled trials (RCTs) on IVF and ICSI subject to selective outcome reporting and is this related to sponsorship? There are inconsistencies, independent from sponsorship, in the reporting of primary outcome measures in the majority of IVF and ICSI trials, indicating selective outcome reporting. RCTs are subject to bias at various levels. Of these biases, selective outcome reporting is particularly relevant to IVF and ICSI trials since there is a wide variety of outcome measures to choose from. An established cause of reporting bias is sponsorship. It is, at present, unknown whether RCTs in IVF/ICSI are subject to selective outcome reporting and whether this is related with sponsorship. We systematically searched RCTs on IVF and ICSI published between January 2009 and March 2016 in MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and the publisher subset of PubMed. We analysed 415 RCTs. Per included RCT, we extracted data on impact factor of the journal, sample size, power calculation, and trial registry and thereafter data on primary outcome measure, the direction of trial results and sponsorship. Of the 415 identified RCTs, 235 were excluded for our primary analysis, because the sponsorship was not reported. Of the 180 RCTs included in our analysis, 7 trials did not report on any primary outcome measure and 107 of the remaining 173 trials (62%) reported on surrogate primary outcome measures. Of the 114 registered trials, 21 trials (18%) provided primary outcomes in their manuscript that were different from those in the trial registry. This indicates selective outcome reporting. We found no association between selective outcome reporting and sponsorship. We ran additional analyses to include the trials that had not reported sponsorship and found no outcomes that differed from our primary analysis. Since the majority of the trials did not report on sponsorship, there is a risk on sampling bias. IVF and ICSI trials are subject, to

  3. Comparison of Rating Scales in the Development of Patient-Reported Outcome Measures for Children with Eye Disorders.

    PubMed

    Hatt, Sarah R; Leske, David A; Wernimont, Suzanne M; Birch, Eileen E; Holmes, Jonathan M

    2017-03-01

    A rating scale is a critical component of patient-reported outcome instrument design, but the optimal rating scale format for pediatric use has not been investigated. We compared rating scale performance when administering potential questionnaire items to children with eye disorders and their parents. Three commonly used rating scales were evaluated: frequency (never, sometimes, often, always), severity (not at all, a little, some, a lot), and difficulty (not difficult, a little difficult, difficult, very difficult). Ten patient-derived items were formatted for each rating scale, and rating scale testing order was randomized. Both child and parent were asked to comment on any problems with, or a preference for, a particular scale. Any confusion about options or inability to answer was recorded. Twenty-one children, aged 5-17 years, with strabismus, amblyopia, or refractive error were recruited, each with one of their parents. Of the first 10 children, 4 (40%) had problems using the difficulty scale, compared with 1 (10%) using frequency, and none using severity. The difficulty scale was modified, replacing the word "difficult" with "hard." Eleven additional children (plus parents) then completed all 3 questionnaires. No children had problems using any scale. Four (36%) parents had problems using the difficulty ("hard") scale and 1 (9%) with frequency. Regarding preference, 6 (55%) of 11 children and 5 (50%) of 10 parents preferred using the frequency scale. Children and parents found the frequency scale and question format to be the most easily understood. Children and parents also expressed preference for the frequency scale, compared with the difficulty and severity scales. We recommend frequency rating scales for patient-reported outcome measures in pediatric populations.

  4. Effect of Secukinumab on Patient-Reported Outcomes in Patients With Active Ankylosing Spondylitis: A Phase III Randomized Trial (MEASURE 1).

    PubMed

    Deodhar, Atul A; Dougados, Maxime; Baeten, Dominique L; Cheng-Chung Wei, James; Geusens, Piet; Readie, Aimee; Richards, Hanno B; Martin, Ruvie; Porter, Brian

    2016-12-01

    To evaluate the effect of secukinumab (interleukin-17A inhibitor) on patient-reported outcomes in patients with active ankylosing spondylitis (AS). In this phase III study, 371 patients were randomized (1:1:1) to receive intravenous (IV) secukinumab 10 mg/kg at baseline and weeks 2 and 4 followed by subcutaneous (SC) secukinumab 150 mg every 4 weeks (IV→150 mg group), or SC secukinumab 75 mg every 4 weeks (IV→75 mg group), or placebo. Patient-reported outcomes included the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI criteria for 50% improvement (BASDAI 50), Short Form 36 (SF-36) physical component summary (PCS) score and mental component summary (MCS) score, Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire, Bath Ankylosing Spondylitis Functional Index (BASFI), EuroQol 5-domain (EQ-5D) questionnaire, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Work Productivity and Activity Impairment-General Health questionnaire (WPAI-GH). At week 16, secukinumab IV→150 mg or IV→75 mg was associated with statistically and clinically significant improvements from baseline versus placebo in the BASDAI (-2.3 for both regimens versus -0.6; P < 0.0001 and P < 0.001, respectively), SF-36 PCS (5.6 for both regimens versus 1.0; P < 0.0001 and P < 0.001, respectively), and ASQoL (-3.6 for both regimens versus -1.0; P < 0.0001 and P < 0.001, respectively). Clinically significant improvements in the SF-36 MCS, BASFI, EQ-5D, and BASDAI 50 were observed with both secukinumab groups versus placebo at week 16; improvements were also observed in the FACIT-F and WPAI-GH. All improvements were sustained through week 52. Our findings indicate that secukinumab provides significant and sustained improvements in patient-reported disease activity and health-related quality of life, and reduces functional impairment, fatigue, and impact of disease on work productivity in patients with active AS. © 2016 The

  5. Long-Term Outcome of Open Plantar Fascia Release.

    PubMed

    MacInnes, Alasdair; Roberts, Sam C; Kimpton, Jessica; Pillai, Anand

    2016-01-01

    Plantar fasciitis is thought to be a self-limiting condition best treated by conservative measures, but despite this many patients have a prolonged duration of symptoms and surgery may be indicated. Partial plantar fascial release is reported to have a short-term success rate of up to 80%, but anecdotally this was not thought to represent our local experience. An audit of long-term patient-reported outcomes following open partial plantar fascia release was performed. A total of 30 patients (33 feet) were identified over a 10-year period and case notes were reviewed. Patients were contacted by letter and invited to complete 2 validated patient-reported outcome score questionnaires (Visual Analog Scale-Foot and Ankle [VAS-FA] and Manchester Oxford Foot Questionnaire [MOXFQ]). Responses were received from 24 patients (26 feet). The average ages were 42.4 (range 24-61) for male and 46.2 (range 33-60) for female patients, with a female/male ratio of 2.7:1. The average duration of treatment prior to operative intervention was 3.1 years (range 1-5). Preoperatively, our cohort underwent a range of conservative measures. All patients were reviewed postoperatively, and average time from surgery to completion of questionnaires was 80 months (range 14-130). The outcomes were worse in patients who had received preoperative steroid injections and this was found to be statistically significant. The mean MOXFQ score was 33.6 ± 3.9 (0-64). Mean VAS-FA score was 57.8 ± 4.9 (24-100). This study found a negative correlation between duration of follow-up and outcome, in both MOXFQ and VAS-FA, showing that patients continued to improve many years postoperatively. The authors also found worse outcomes with preoperative steroid injections, better outcomes in older patients, and a weak gender bias, suggesting results in men were better than those in women. A prolonged recovery period and generally poor outcomes leads the authors to suggest that open plantar fascia release is of

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

    PubMed

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

    2016-01-01

    In this case report, the authors describe the implementation of a system for collecting patient-reported outcomes and integrating results in an electronic health record. The objective was to identify lessons learned in overcoming barriers to collecting and integrating patient-reported outcomes in an electronic health record. The authors analyzed qualitative data in 42 documents collected from system development meetings, written feedback from users, and clinical observations with practice staff, providers, and patients. Guided by the Unified Theory on the Adoption and Use of Information Technology, 5 emergent themes were identified. Two barriers emerged: (i) uncertain clinical benefit and (ii) time, work flow, and effort constraints. Three facilitators emerged: (iii) process automation, (iv) usable system interfaces, and (v) collecting patient-reported outcomes for the right patient at the right time. For electronic health record-integrated patient-reported outcomes to succeed as useful clinical tools, system designers must ensure the clinical relevance of the information being collected while minimizing provider, staff, and patient burden. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  7. The Smoking Abstinence Questionnaire: Measurement of smokers’ abstinence-related expectancies

    PubMed Central

    Hendricks, Peter S.; Wood, Sabrina B.; Baker, Majel R.; Delucchi, Kevin L.; Hall, Sharon M.

    2011-01-01

    AIM To develop and validate a measure of smokers’ expectancies for the abstinence process upon quitting smoking: the Smoking Abstinence Questionnaire (SAQ). DESIGN Principal component analysis and other psychometric analyses of self-report data. SETTING San Francisco, California. PARTICIPANTS 507 adult smokers of at least 10 cigarettes per day diverse in gender, sexual orientation, and ethnoracial status. MEASUREMENTS The primary measure was a draft version of the SAQ. Additional measures assessed a variety of other smoking-related constructs. FINDINGS Principal component analyses revealed 10 factors of the SAQ: Withdrawal, Social Improvement/Nonsmoker Identity, Adverse Outcomes, Treatment Effectiveness, Common Reasons, Barriers to Treatment, Social Support, Optimistic Outcomes, Coffee Use, and Weight Gain. The SAQ factors demonstrated internal consistencies ranging from .62 to .85 and were associated with tobacco dependence, motivation to quit, abstinence self-efficacy, withdrawal symptoms, dietary restraint, shape and weight concern, and tobacco use expectancies. The SAQ predicted smoking-related constructs above and beyond tobacco use expectancies, suggesting that abstinence-related expectancies and tobacco use expectancies are distinct from one another. CONCLUSIONS A newly developed questionnaire, the SAQ, appears to reliably capture smokers’ expectancies for abstinence (Withdrawal, Social Improvement/Nonsmoker Identity, Adverse Outcomes, Common Reasons, Optimistic Outcomes, Coffee Use, and Weight Gain) and expectancies related to the success of a quit attempt (Treatment Effectiveness, Barriers to Treatment, and Social Support). It remains to be seen how far any of these expectancies predict attempts to quit, withdrawal, treatment utilization and response, and quitting success above and beyond existing measures. PMID:21205053

  8. SRTR center-specific reporting tools: Posttransplant outcomes.

    PubMed

    Dickinson, D M; Shearon, T H; O'Keefe, J; Wong, H-H; Berg, C L; Rosendale, J D; Delmonico, F L; Webb, R L; Wolfe, R A

    2006-01-01

    Measuring and monitoring performance--be it waiting list and posttransplant outcomes by a transplant center, or organ donation success by an organ procurement organization and its partnering hospitals--is an important component of ensuring good care for people with end-stage organ failure. Many parties have an interest in examining these outcomes, from patients and their families to payers such as insurance companies or the Centers for Medicare and Medicaid Services; from primary caregivers providing patient counseling to government agencies charged with protecting patients. The Scientific Registry of Transplant Recipients produces regular, public reports on the performance of transplant centers and organ procurement organizations. This article explains the statistical tools used to prepare these reports, with a focus on graft survival and patient survival rates of transplant centers--especially the methods used to fairly and usefully compare outcomes of centers that serve different populations. The article concludes with a practical application of these statistics--their use in screening transplant center performance to identify centers that may need remedial action by the OPTN/UNOS Membership and Professional Standards Committee.

  9. Farming characteristics and self-reported health outcomes of Irish farmers.

    PubMed

    van Doorn, D; Richardson, N; Storey, A; Osborne, A; Cunningham, C; Blake, C; McNamara, J

    2018-05-17

    Irish farmers represent a 'high-risk' group for non-communicable diseases, which, arguably, pose a greater occupational health challenge for farmers. To date, there has been little exploration of the farming characteristics associated with farmers' poor health outcomes. To examine the relationship between farming and male farmers' self-reported health outcomes and to compare the study findings to national health studies to explore which factors specifically are associated with Irish farmers' poorer health outcomes relative to the general population. This cross-sectional survey research used self-reported quantitative data on the health outcomes and health behaviours of male farmers from the South-East of Ireland. Data were entered into SPSS and descriptive and binary regression techniques were used for data analysis. There were 314 participants (99% response rate). Age, full-time farming and dairy farming significantly impacted self-reported health outcomes and health behaviours. There was a high prevalence of self-reported arthritis compared with the national average of Irish males. 'Younger' farmers (<45 years) were more likely to engage in harmful health behaviours such as smoking and 'binge-drinking' one or more times per week. This study identified self-reported patterns of risky lifestyle behaviours among particular subgroups of Irish farmers for whom targeted health interventions are warranted. Interventions are particularly important for younger farmers who may see themselves as invincible and impregnable to ill-health.

  10. Patient Reported Outcomes Measurement Information System in Children with Crohn’s Disease

    PubMed Central

    Arvanitis, Marina; DeWalt, Darren A.; Martin, Christopher F.; Long, Millie D.; Chen, Wenli; Jaeger, Beth; Sandler, Robert S.; Kappelman, Michael D.

    2016-01-01

    Objectives To assess the criterion validity and responsiveness of Patient Reported Outcomes Measurement Information System (PROMIS) in a web-based cohort of children with Crohn’s disease. Study design We recruited children, ages 9 to 17, with Crohn’s disease and their parents from the web-based Crohn’s and Colitis Foundation of America Kids & Teens Study cohort. Upon entry into the cohort and 6 months later, children self-reported Crohn’s disease activity, health-related quality of life and PROMIS domains of pain interference, anxiety, depression, fatigue and peer relationships. Results Mean PROMIS scores for the 276 participating patients were worse among those with worse self-reported Crohn’s disease activity (per Short Crohn’s disease Activity Index, p<0.005 for all), Crohn’s disease activity in the prior 6 months (per Manitoba Index, p<0.01 for all) and health related quality of life (per IMPACT-35, p<0.001 for all). One hundred forty-three patients and their parents completed follow-up questionnaires, 75% of whom reported stable disease activity. Those with improved Crohn’s disease activity reported improved PROMIS scores, and those with worsened Crohn’s disease activity reported worse PROMIS scores for all domains except anxiety. All participants reported improved anxiety from baseline, but those with stable or worsened Crohn’s disease activity reported less improvement (p=0.07). Conclusions PROMIS scores were significantly associated with known groups of Crohn’s disease activity in a linear and clinically meaningful manner, and responded to change in Crohn’s disease activity over a 6-month period. This supports the criterion validity and responsiveness of pediatric PROMIS. PMID:27157449

  11. Musculoskeletal impact of the use of various types of electronic devices on university students in Hong Kong: An evaluation by means of self-reported questionnaire.

    PubMed

    Woo, Eugenia H C; White, Peter; Lai, Christopher W K

    2016-12-01

    Despite the increasingly widespread popularity of electronic devices, there are limited comprehensive studies on the effects of usage and exposure to multiple electronic devices over extended periods of time. Therefore, this study explored the cumulative musculoskeletal implications of exposure to various electronic devices among university students. A self-reported questionnaire was administered in the university in Hong Kong and students provided information about the frequency and duration of electronic devices use, including computers, mobile phones and game consoles, and reported on any musculoskeletal pain or discomfort that may relate to electronic devices usage in the immediate 12 months prior to the survey date. A total of 503 university students (59% males and 41% females) aged 18-25 years completed the questionnaire. The results showed that 251 (49.9%) respondents reported upper limb musculoskeletal symptoms, particularly in the neck and shoulder regions. Among these, 155 (61.8%) indicated that their discomfort was related to electronic device usage. Statistically significant differences in exposure to electronic devices and musculoskeletal outcomes between genders were found (p < 0.05). The use of electronic devices and habitual postures were associated with musculoskeletal problems among university students in Hong Kong. This phenomenon highlights the urgent need for ergonomics education and recommendations to increase students' awareness of musculoskeletal wellbeing. Copyright © 2016 Elsevier Ltd. All rights reserved.

  12. Minimum 20 Years Long-term Clinical Outcome After Spinal Fusion and Instrumentation for Scoliosis: Comparison of the SRS-22 Patient Questionnaire With That in Nonscoliosis Group.

    PubMed

    Iida, Takahiro; Suzuki, Nobumasa; Kono, Katsuki; Ohyama, Yasumasa; Imura, Jyunya; Ato, Akihisa; Ozeki, Satoru; Nohara, Yutaka

    2015-08-15

    A retrospective minimum 20-year follow-up study using 4 standard self-administered questionnaires, one of which, the SRS-22 was also administered to control groups. To evaluate long-term postoperative pain and other clinical outcomes of scoliosis correction and fusion surgery with Harrington instrumentation using Moe square-ended rods for better preservation of sagittal alignment. Only a few long-term outcome studies have used standardized and validated self-administered tools, and no studies have established SRS-22 control data within their own population. There is no previous minimum 20-year follow-up evaluation after correction surgery preserving thoracic kyphosis and lumbar lordosis. Of 86 consecutive patients who underwent instrumentation surgery for scoliosis by a single surgeon, 61 patients participated using Japanese Orthopaedic Association, Roland-Morris Disability Questionnaire, Oswestry Disability Index, and Scoliosis Research Society (SRS-22) questionnaires and 51 patients were included in this study. Results were analyzed for pain and other clinical outcomes. A total of 771 hospital employees were sent SRS-22 questionnaires. A total of 763 responded, resulting in 2 control groups composed of nonscoliosis and untreated mild scoliosis controls of the same culture and language as the long-term follow-up group. The prevalence of continuous low back pain was about 15%. Average Japanese Orthopaedic Association, Oswestry Disability Index, and Roland-Morris Disability Questionnaire scores at follow-up were 25 points, 7.3%, and 1.6, respectively. The average SRS-22 scores were 4.2 (function), 4.3 (pain), 3.7 (self-image), and 3.9 (mental health) for the postoperative follow-up group compared with 4.5 (function), 4.3 (pain), 3.5 (self-image), and 3.5 (mental health) for the nonscoliosis controls. Improved preservation of normal sagittal alignment resulted in a prevalence of low back pain comparable with the age-matched general population. Moreover, SRS-22

  13. [Experiences with the Three-Factor Eating Questionnaire-R21 in young men].

    PubMed

    Czeglédi, Edit

    2017-09-01

    Eating behaviours play a crucial role in the development of obesity. To conduct a psychometric analysis of the Three-Factor Eating Questionnaire-R21 and to investigate the correlates of obesogenic eating behaviours among males. Participants of the cross-sectional questionnaire-based study were male university students (n = 239, mean of age: 20.3 years, SD = 2.78 years). self-reported body weight and body height, Three-Factor Eating Questionnaire-R21, Trait Anxiety Scale of the State-Trait Anxiety Inventory. Results of confirmatory factor analysis supported the theoretical model of the Three-Factor Eating Questionnaire-R21 (χ 2 (186) = 366.1, p<0.001, CFI = 0.959, TLI = 0.954, RMSEA = 0.064). Internal consistency of the scales was adequate (Cronbach's α: 0.79-0.88). Body Mass Index and trait anxiety showed significant, positive associations with eating behaviours, such as uncontrolled eating, cognitive restraint, and emotional eating. Results support the construct validity and reliability of the Three-Factor Eating Questionnaire-R21 among males and highlight the importance of taking psychological factors into account in the prevention of obesity. Orv Hetil. 2017; 158(37): 1469-1477.

  14. 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

  15. 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…

  16. Patient-reported outcomes and diabetes technology: a systematic review of the literature.

    PubMed

    Rubin, Richard R; Peyrot, Mark

    2010-08-01

    Advanced diabetes technology should have benefits not only in terms of clinical outcomes, but also in terms of patient-reported outcomes. The objective of this paper is to review the methodology and findings of studies that assessed the effects of diabetes technologies such as continuous subcutaneous insulin infusion (CSII), continuous glucose monitoring (CGM), and integrated CSII/CGM on patientreported outcomes. The existing literature in pediatric and adult patients is limited, so there is no conclusive evidence that use of CSII, CGM, or integrated CSII/CGM systems produce improved patient-reported outcomes, but most studies provide evidence that these technologies yield some patient-reported outcomes advantages, and few indicate any disadvantages. We expect that more robust studies in the future will provide further evidence regarding the impact of these technologies for patient-reported outcomes, including general health-related quality-of-life, diabetesspecific quality-of-life, treatment satisfaction, and treatment preference.

  17. 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…

  18. 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…

  19. Italian Translation of the Questionnaire for Professional Training Evaluation

    ERIC Educational Resources Information Center

    Fregonese, Chiara; Caputo, Andrea; Langher, Viviana

    2018-01-01

    This work illustrates the psychometric properties of the Italian version of the Questionnaire for Professional Training Evaluation, designed and validated by Grohmann and Kauffeld. This 12-item questionnaire provides for the evaluation of different training outcomes, is time-efficient, applicable to several professional contexts and shows sound…

  20. Using Symptom and Interference Questionnaires to Identify Recovery Among Children With Anxiety Disorders

    PubMed Central

    2016-01-01

    Questionnaires are widely used in routine clinical practice to assess treatment outcomes for children with anxiety disorders. This study was conducted to determine whether 2 widely used child and parent report questionnaires of child anxiety symptoms and interference (Spence Child Anxiety Scale [SCAS-C/P] and Child Anxiety Impact Scale [CAIS-C/P]) accurately identify recovery from common child anxiety disorder diagnoses as measured by a ‘gold-standard’ diagnostic interview. Three hundred thirty-seven children (7–12 years, 51% female) and their parents completed the ADIS-IV-C/P diagnostic interview and questionnaire measures (SCAS-C/P and CAIS-C/P) before (Time 1) and after (Time 2) treatment or wait-list. Time 2 parent reported interference (CAIS-P) was found to be a good predictor of absence of any diagnoses (area under the curve [AUC] = .81). In terms of specific diagnoses, Time 2 SCAS-C/P separation anxiety subscale (SCAS-C/P-SA) identified recovery from separation anxiety disorder well (SCAS-C-SA, AUC = .80; SCAS-P-SA, AUC = .82) as did the CAIS-P (AUC = .79). The CAIS-P also successfully identified recovery from social phobia (AUC = .78) and generalized anxiety disorder (AUC = .76). These AUC values were supported by moderate to good sensitivity (.70–.78) and specificity (.70–.73) at the best identified cut-off scores. None of the measures successfully identified recovery from specific phobia. The results suggest that questionnaire measures, particularly the CAIS-P, can be used to identify whether children have recovered from common anxiety disorders, with the exception of specific phobias. Cut-off scores have been identified that can guide the use of routine outcome measures in clinical practice. PMID:27845527

  1. Using symptom and interference questionnaires to identify recovery among children with anxiety disorders.

    PubMed

    Evans, Rachel; Thirlwall, Kerstin; Cooper, Peter; Creswell, Cathy

    2017-07-01

    Questionnaires are widely used in routine clinical practice to assess treatment outcomes for children with anxiety disorders. This study was conducted to determine whether 2 widely used child and parent report questionnaires of child anxiety symptoms and interference (Spence Child Anxiety Scale [SCAS-C/P] and Child Anxiety Impact Scale [CAIS-C/P]) accurately identify recovery from common child anxiety disorder diagnoses as measured by a 'gold-standard' diagnostic interview. Three hundred thirty-seven children (7-12 years, 51% female) and their parents completed the ADIS-IV-C/P diagnostic interview and questionnaire measures (SCAS-C/P and CAIS-C/P) before (Time 1) and after (Time 2) treatment or wait-list. Time 2 parent reported interference (CAIS-P) was found to be a good predictor of absence of any diagnoses (area under the curve [AUC] = .81). In terms of specific diagnoses, Time 2 SCAS-C/P separation anxiety subscale (SCAS-C/P-SA) identified recovery from separation anxiety disorder well (SCAS-C-SA, AUC = .80; SCAS-P-SA, AUC = .82) as did the CAIS-P (AUC = .79). The CAIS-P also successfully identified recovery from social phobia (AUC = .78) and generalized anxiety disorder (AUC = .76). These AUC values were supported by moderate to good sensitivity (.70-.78) and specificity (.70-.73) at the best identified cut-off scores. None of the measures successfully identified recovery from specific phobia. The results suggest that questionnaire measures, particularly the CAIS-P, can be used to identify whether children have recovered from common anxiety disorders, with the exception of specific phobias. Cut-off scores have been identified that can guide the use of routine outcome measures in clinical practice. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  2. Development and Validation of the Cognitive Behavioral Physical Activity Questionnaire.

    PubMed

    Schembre, Susan M; Durand, Casey P; Blissmer, Bryan J; Greene, Geoffrey W

    2015-01-01

    Develop and demonstrate preliminary validation of a brief questionnaire aimed at assessing social cognitive determinants of physical activity (PA) in a college population. Quantitative and observational. A midsized northeastern university. Convenience sample of 827 male and female college students age 18 to 24 years. International Physical Activity Questionnaire and a PA stage-of-change algorithm. A sequential process of survey development, including item generation and data reduction analyses by factor analysis, was followed with the goal of creating a parsimonious questionnaire. Structural equation modeling was used for confirmatory factor analysis and construct validation was confirmed against self-reported PA and stage of change. Validation analyses were replicated in a second, independent sample of 1032 college students. Fifteen items reflecting PA self-regulation, outcome expectations, and personal barriers explained 65% of the questionnaire data and explained 28.6% and 39.5% of the variance in total PA and moderate-to-vigorous-intensity PA, respectively. Scale scores were distinguishable across the stages of change. Findings were similar when the Cognitive Behavioral Physical Activity Questionnaire (CBPAQ) was tested in a similar and independent sample of college students (40%; R (2) moderate-to-vigorous-intensity PA = .40; p < .001). The CBPAQ successfully explains and predicts PA behavior in a college population, warranting its incorporation into future studies aiming at understanding and improving on PA behavior in college students.

  3. Review of patient-reported outcome instruments measuring health-related quality of life and satisfaction in patients with type 2 diabetes treated with oral therapy.

    PubMed

    Roborel de Climens, Aude; Tunceli, Kaan; Arnould, Benoit; Germain, Nicola; Iglay, Kristy; Norquist, Josephine; Brodovicz, Kimberly G

    2015-04-01

    Treatments and their mode of administration may represent a burden for patients and can therefore impact their health-related quality of life (HRQL) or treatment/health satisfaction. Patients with type 2 diabetes mellitus (T2DM) can be treated with oral hypoglycemic agents (OHAs), injectable medications (such as insulin), or a combination of agents. This review aimed to identify patient-reported outcome (PRO) instruments measuring HRQL and/or satisfaction that could differentiate between oral medications based on medication related attributes such as efficacy, tolerability, weight loss, dosing frequency and pill burden. Medline, Embase, PsycINFO, Cochrane Library and the Patient-Reported Outcome and Quality of Life Questionnaires (PROQOLID) biomedical databases were searched to identify instruments and document their development methodology, content and psychometric properties (i.e. validity, reliability), responsiveness and ability to detect changes between treatments. Nineteen instruments were retained based on their potential to differentiate between OHAs. Ten instruments assessed HRQL, amongst which the Audit of Diabetes Dependent Quality of Life, Diabetes 39, Diabetes Health Profile and Impact of Weight on Quality of Life displayed good psychometric properties in T2DM populations and comprehensive HRQL content. Nine instruments assessed satisfaction. Both the Oral Hypoglycemic Agent Questionnaire (OHAQ) and Diabetes Medication Satisfaction (DiabMedSat) Questionnaire have highly relevant content regarding drug attributes. The OHAQ is specific to oral treatment and the DiabMedSat includes HRQL items. The Diabetes Treatment Satisfaction Questionnaire is a standard instrument that is extensively used and provides conclusive results in studies of patients with T2DM. Very few of the existing PRO instruments are specific to OHAs. Despite satisfaction instruments being recommended to differentiate between OHAs in studies of T2DM based on medication attributes, we find

  4. Self-reported confidence in recall as a predictor of validity and repeatability of physical activity questionnaire data.

    PubMed

    Cust, Anne E; Armstrong, Bruce K; Smith, Ben J; Chau, Josephine; van der Ploeg, Hidde P; Bauman, Adrian

    2009-05-01

    Self-reported confidence ratings have been used in other research disciplines as a tool to assess data quality, and may be useful in epidemiologic studies. We examined whether self-reported confidence in recall of physical activity was a predictor of the validity and retest reliability of physical activity measures from the European Prospective Investigation into Cancer and Nutrition (EPIC) past-year questionnaire and the International Physical Activity Questionnaire (IPAQ) last-7-day questionnaire.During 2005-2006 in Sydney, Australia, 97 men and 80 women completed both questionnaires at baseline and at 10 months and wore an accelerometer as an objective comparison measure for three 7-day periods during the same timeframe. Participants rated their confidence in recalling physical activity for each question using a 5-point scale and were dichotomized at the median confidence value. Participants in the high-confidence group had higher validity and repeatability coefficients than those in the low-confidence group for most comparisons. The differences were most apparent for validity of IPAQ moderate activity: Spearman correlation rho = 0.34 (95% confidence interval [CI] = 0.08 to 0.55) and 0.01 (-0.17 to 0.20) for high- and low-confidence groups, respectively; and repeatability of EPIC household activity: rho = 0.81 (0.72 to 0.87) and 0.63 (0.48 to 0.74), respectively, and IPAQ vigorous activity: rho = 0.58 (0.43 to 0.70) and 0.29 (0.07 to 0.49), respectively. Women were less likely than men to report high recall confidence of past-year activity (adjusted odds ratio = 0.38; 0.18 to 0.80). Confidence ratings could be useful as indicators of recall accuracy (ie, validity and repeatability) of physical activity measures, and possibly for detecting differential measurement error and identifying questionnaire items that require improvement.

  5. Influence of peer review on the reporting of primary outcome(s) and statistical analyses of randomised trials.

    PubMed

    Hopewell, Sally; Witt, Claudia M; Linde, Klaus; Icke, Katja; Adedire, Olubusola; Kirtley, Shona; Altman, Douglas G

    2018-01-11

    Selective reporting of outcomes in clinical trials is a serious problem. We aimed to investigate the influence of the peer review process within biomedical journals on reporting of primary outcome(s) and statistical analyses within reports of randomised trials. Each month, PubMed (May 2014 to April 2015) was searched to identify primary reports of randomised trials published in six high-impact general and 12 high-impact specialty journals. The corresponding author of each trial was invited to complete an online survey asking authors about changes made to their manuscript as part of the peer review process. Our main outcomes were to assess: (1) the nature and extent of changes as part of the peer review process, in relation to reporting of the primary outcome(s) and/or primary statistical analysis; (2) how often authors followed these requests; and (3) whether this was related to specific journal or trial characteristics. Of 893 corresponding authors who were invited to take part in the online survey 258 (29%) responded. The majority of trials were multicentre (n = 191; 74%); median sample size 325 (IQR 138 to 1010). The primary outcome was clearly defined in 92% (n = 238), of which the direction of treatment effect was statistically significant in 49%. The majority responded (1-10 Likert scale) they were satisfied with the overall handling (mean 8.6, SD 1.5) and quality of peer review (mean 8.5, SD 1.5) of their manuscript. Only 3% (n = 8) said that the editor or peer reviewers had asked them to change or clarify the trial's primary outcome. However, 27% (n = 69) reported they were asked to change or clarify the statistical analysis of the primary outcome; most had fulfilled the request, the main motivation being to improve the statistical methods (n = 38; 55%) or avoid rejection (n = 30; 44%). Overall, there was little association between authors being asked to make this change and the type of journal, intervention, significance of the

  6. The Role of Appearance: Definition of Appearance-Pain (App-Pain) and Systematic Review of Patient-Reported Outcome Measures Used in Literature.

    PubMed

    Barone, M; Cogliandro, A; Salzillo, R; Tambone, V; Persichetti, P

    2018-06-19

    The objectives of the current study were: (1) to perform a systematic review of the existing scientific literature on appearance and any subsequently related disorders and (2) to research in the literature the correlation between the role of appearance and patient's disease. A systematic review protocol was developed a priori in accordance with the Preferred Reporting for Items for Systematic Reviews and Meta-Analyses-Protocols (PRISMA-P) guidance. A multistep search of the PubMed, MEDLINE, PreMEDLINE, Embase, Ebase, CINAHL, PsychINFO and Cochrane databases was performed to identify studies on patient satisfaction, quality of life, and body image. Our search generated a total of 347 articles. We performed a systematic review of the 18 studies, which had sufficient data and met all inclusion criteria. All studies identified from the literature review were assessed to determine the utilization of validated patient satisfaction questionnaires. The questionnaires were analyzed by reviewers to assess adherence to the rules of the US Food and Drug Administration and the Scientific Advisory Committee of the Medical Outcomes Trust. We identified 27 individual questionnaires. We summarized development and validation characteristics and content of the 27 validated measures used in the studies. This is the first systematic review to identify and critically appraise patient-reported outcome measures for appearance and body image using internationally accepted criteria. DAS59 was deemed to have adequate levels of methodological and psychometric evidence. We also introduced the concept of Appearance-Pain which consists of the recomposed systematic view of the experimental indicators of suffering, linked to one of the dimensions of appearance. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www

  7. Patient-reported Outcome Measurements on the Tolerance of Magnetic Resonance Imaging-guided Radiation Therapy

    PubMed Central

    Tetar, Shyama; Bakker, Roosje; Jeulink, Marloes; Slotman, Ben J.; Oei, Swie; Haasbeek, Cornelis; De Jong, Karel; Senan, Suresh; Lagerwaard, Frank

    2018-01-01

    Purpose Magnetic resonance imaging-guided radiation therapy (MRgRT) requires patient positioning within the MR bore and prolonged MR imaging during delivery, both of which are new in radiation oncology. Patient tolerance of MRgRT was prospectively evaluated using patient-reported outcome questionnaires (PRO-Q). Methods Our MRgRT procedure involves daily high-resolution MR scanning, limited re-contouring, daily plan re-optimization, quality assurance (QA), and gated delivery. Patients with claustrophobia are excluded. Mean fraction duration was 45 and 60 minutes for stereotactic treatments during free-breathing and breath-hold, respectively. Patient-controlled video-feedback was used for breath-hold delivery. PRO-Qs collected in the first 150 patients treated included questions on MR-related complaints and also evaluated aspects of active participation. Results Almost one-third of patients (29%) scored at least one PRO-Q item on MR-related complaints as ‘moderate’ or ‘very much’, with noise, feeling cold, and paresthesia being the most frequently scored in this way. Considerable anxiety was reported by 5%, but no medication was required for this in any patient. Patient participation in video feedback for breath-hold delivery was appreciated by the majority of patients, all of whom completed the procedure. Only 5% of patients considered treatment duration to be unacceptably long. Conclusion Despite the lengthy MRgRT procedure, outcomes of PRO-Q indicate that it was well-tolerated by patients. PMID:29719739

  8. Prevalence and Consistency in Surgical Outcome Reporting for Femoroacetabular Impingement Syndrome: A Scoping Review.

    PubMed

    Reiman, Michael P; Peters, Scott; Sylvain, Jonathan; Hagymasi, Seth; Ayeni, Olufemi R

    2018-04-01

    The purposes of this review were (1) to collate and synthesize research studies reporting any outcome measure on both open and arthroscopic surgical treatment of femoroacetabular impingement (FAI) syndrome and (2) to report the prevalence and consistency of outcomes across the included studies. A computer-assisted literature search of the MEDLINE, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and Embase databases was conducted using keywords related to FAI syndrome and both open and arthroscopic surgical outcomes, resulting in 2,614 studies, with 163 studies involving 14,824 subjects meeting the inclusion criteria. Two authors independently reviewed study inclusion and data extraction with independent verification. The prevalence of reported outcomes was calculated and verified by separate authors. Between 2004 and 2016, there has been a 2,600% increase in the publication of surgical outcome studies. Patients had a mean duration of symptoms of 27.7 ± 21.5 months before surgery. Arthroscopy was the surgical treatment used in 71% of studies. The mean final follow-up period after surgery was 32.2 ± 17.3 months. Follow-up time frames were reported in 78% of studies. Ten different patient-reported outcome measures were reported. The alpha angle was reported to be measured 42% less frequently as a surgical outcome than as a surgical indication. Surgical complications were addressed in only 53% of studies and failures in 69%. Labral pathology (91% of studies reporting) and chondral pathology (61%) were the primary coexisting pathologies reported. Clinical signs, as defined by the Warwick Agreement on FAI syndrome, were reported in fewer than 25% of studies. Most FAI syndrome patients have longstanding pain and potential coexisting pathology. Patient-reported outcome measures and diagnostic imaging are the most frequently reported outcomes. Measures of hip strength and range of motion are under-reported. It is unclear whether the inconsistency in

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

    PubMed

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

    2015-11-11

    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. 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. 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. The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): CRD42015017525. Published by the BMJ

  10. A description of the severity of equestrian-related injuries (ERIs) using clinical parameters and patient-reported outcomes.

    PubMed

    Papachristos, Alexander; Edwards, Elton; Dowrick, Adam; Gosling, Cameron

    2014-09-01

    Despite a number of injury prevention campaigns and interventions, horse riding continues to be a dangerous activity, resulting in more accidents per hour than motorcycling, skiing and football. Injuries are often serious, with one in four patients requiring admission to hospital. This study aims to describe the severity of equestrian-related injuries (ERIs) using both clinical parameters and patient-reported outcomes. A retrospective study of all patients aged ≥18 years admitted to The Alfred Hospital between January 2003 and January 2008 with an ERI was performed. Specific clinical data were extracted from the medical record. In addition, a questionnaire was conducted identifying the details of the accident, the required recovery time and levels of ongoing pain and physical disability. During the study period 172 patients met the inclusion criteria. There were three deaths (2%). Eighty-two patients (48%) suffered head injuries. Forty-one patients (24%) were admitted to the ICU and 31 patients (18%) required mechanical ventilation. On discharge, 41 patients (24%) required transfer to a sub-acute rehabilitation facility. One-hundred-and-twenty-four patients (72%) completed the questionnaire. Thirty-nine respondents (31%) were not wearing a helmet. Among patients injured for more than 6 months, 38 (35%) still experienced moderate or severe pain or disability. Ninety-five patients had returned to work at the time of review, among which 47(50%) required longer than 6 months to recover, and 40 (42%) returned at a reduced capacity. The clinical and patient-reported outcomes of ERIs requiring hospital admission are poor. Persistent pain and disability are common, even up to 5 years post-injury. A large proportion of patients required longer than 6 months to return to work and many return at a reduced capacity. Copyright © 2014 Elsevier Ltd. All rights reserved.

  11. Polish Adaptation of Wrist Evaluation Questionnaires.

    PubMed

    Czarnecki, Piotr; Wawrzyniak-Bielęda, Anna; Romanowski, Leszek

    2015-01-01

    Questionnaires evaluating hand and wrist function are a very useful tool allowing for objective and systematic recording of symptoms reported by the patients. Most questionnaires generally accepted in clinical practice are available in English and need to be appropriately adapted in translation and undergo subsequent validation before they can be used in another culture and language. The process of translation of the questionnaires was based on the generally accepted guidelines of the International Quality of Life Assessment Project (IQOLA). First, the questionnaires were translated from English into Polish by two independent translators. Then, a joint version of the translation was prepared collectively and translated back into English. Each stage was followed by a written report. The translated questionnaires were then evaluated by a group of patients. We selected 31 patients with wrist problems and asked them to complete the PRWE, Mayo, Michigan and DASH questionnaires twice at intervals of 3-10 days. The results were submitted for statistical analysis. We found a statistically significant (p<0.05) correlation for the two completions of the questionnaires. A comparison of the PRWE and Mayo questionnaires with the DASH questionnaire also showed a statistically significant correlation (p<0.05). Our results indicate that the cultural adaptation of the translated questionnaires was successful and that the questionnaires may be used in clinical practice.

  12. Time-to-pregnancy and pregnancy outcomes in a South African population

    PubMed Central

    2010-01-01

    Background Time-to-pregnancy (TTP) has never been studied in an African setting and there are no data on the rates of adverse pregnancy outcomes in South Africa. The study objectives were to measure TTP and the rates of adverse pregnancy outcomes in South Africa, and to determine the reliability of the questionnaire tool. Methods The study was cross-sectional and applied systematic stratified sampling to obtain a representative sample of reproductive age women for a South African population. Data on socio-demographic, work, health and reproductive variables were collected on 1121 women using a standardized questionnaire. A small number (n = 73) of randomly selected questionnaires was repeated to determine reliability of the questionnaire. Data was described using simple summary statistics while Kappa and intra-class correlation statistics were calculated for reliability. Results Of the 1121 women, 47 (4.2%) had never been pregnant. Mean gravidity was 2.3 while mean parity was 2.0 There were a total of 2467 pregnancies; most (87%) resulted in live births, 9.5% in spontaneous abortion and 2.2% in still births. The proportion of planned pregnancies was 39% and the median TTP was 6 months. The reliability of the questionnaire for TTP data was good; 63% for all participants and 97% when censored at 14 months. Overall reliability of reporting adverse pregnancy outcomes was very high, ranging from 90 - 98% for most outcomes. Conclusion This is the first comprehensive population-based reproductive health study in South Africa, to describe the biologic fertility of the population, and provides rates for planned pregnancies and adverse pregnancy outcomes. The reliability of the study questionnaire was substantial, with most outcomes within 70 - 100% reliability index. The study provides important public information for health practitioners and researchers in reproductive health. It also highlights the need for public health intervention programmes and epidemiological

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

    PubMed

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

    2016-11-16

    In the management of chronic disease, new models for telemonitoring of patients combined with the choice of electronic patient-reported outcomes (ePRO) are being encouraged, with a clear improvement of both patients' and parents' quality of life. An Italian study demonstrated that ePRO were welcome in patients with rheumatoid arthritis (RA), with excellent matching data. The aim of this study is to evaluate the level of agreement between electronic and paper-and-pencil questionnaire responses. This is an observational prospective study. Patients were randomly assigned to first complete the questionnaire by paper and pencil and then by tablet or in the opposite order. The questionnaire consisted of 3 independent self-assessment visual rating scales (Visual Analog Scale, Global Health score, Patient Global Assessment of Disease Activity) commonly used in different adult patients, including those with rheumatic diseases. A total of 185 consecutive RA patients were admitted to hospital and were enrolled and completed the questionnaire both on paper and on electronic versions. For all the evaluated items, the intrarater degree of agreement between 2 approaches was found to be excellent (intraclass correlation coefficient>0.75, P<.001). An electronic questionnaire is uploaded in a dedicated Web-based tool that could implement a telemonitoring system aimed at improving the follow-up of RA patients. High intrarater reliability between paper and electronic methods of data collection encourage the use of a new digital app with consequent benefit for the overall health care system. ©Oscar Massimiliano Epis, Cinzia Casu, Laura Belloli, Emanuela Schito, Davide Filippini, Marina Muscarà, Maria Giovanna Gentile, Paula Carina Perez Cagnone, Chiara Venerelli, Massimo Sonnati, Irene Schiavetti, Eleonora Bruschi. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.11.2016.

  14. Quality-of-Life Outcomes Following Surface Electromyography Biofeedback as an Adjunct to Pelvic Floor Muscle Training for Urinary Incontinence: A Case Report.

    PubMed

    Hill, Alexandra; Alappattu, Meryl

    2017-05-01

    A non-invasive treatment for urinary incontinence (UI) is surface electromyography (sEMG) biofeedback with pelvic floor muscle (PFM) training. A lack of consensus and evidence exists on the Quality of Life (QoL) outcomes following sEMG biofeedback using surface electrodes at the perineum compared to the more invasive intravaginal probe. This case report examines QoL using sEMG biofeedback at the perineum with PFM training for UI. Single subject case report. The patient was a 61-year-old woman diagnosed with UI. Her chief complaints were nocturia, urine leakage with urgency, and urine leakage with sneezing and coughing. Physical therapy (PT) treatment focused on behavioral modification, PFM strengthening with and without sEMG biofeedback, and therapeutic exercises with PFM contractions. At four weeks from baseline, the patient's PFM strength increased from 2/5 to 4/5 based on the Modified Laycock Scale. Her PFM endurance contraction improved from two seconds to ten seconds. The International Continence Impact Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) score decreased from 6 to 0, the Incontinence Impact Questionnaire - Short Form (IIQ-7) score decreased from 14.3 to 0, and the 3 Incontinence Questions (3IQ) responses did not change. The outcomes from this case report demonstrate a brief course of PT treatment consisting of perineal sEMG biofeedback in conjunction with PFM training demonstrated clinically meaningful improvements in incontinence-related QoL, in addition to improvements in motor function in a woman with mixed UI and nocturia.

  15. The Consumer Reports Effectiveness Score: What Did Consumers Report?

    ERIC Educational Resources Information Center

    Nielsen, Stevan Lars; Smart, David W.; Isakson, Richard L.; Worthen, Vaughn E.; Gregersen, Ann T.; Lambert, Michael J.

    2004-01-01

    From readers' ratings of satisfaction, problem resolution, and perceived emotional change during treatment, Consumer Reports magazine (CR, 1995) concluded both that psychotherapy is effective and that longer, more intensive therapy is more effective. The authors compared prospectively gathered 45-Item Outcome Questionnaire scores (OQ-45; M. J.…

  16. Development of a self-report questionnaire designed for population-based surveillance of gingivitis in adolescents: assessment of content validity and reliability.

    PubMed

    Quiroz, Viviana; Reinero, Daniela; Hernández, Patricia; Contreras, Johanna; Vernal, Rolando; Carvajal, Paola

    2017-01-01

    This study aimed to develop and assess the content validity and reliability of a cognitively adapted self-report questionnaire designed for surveillance of gingivitis in adolescents. Ten predetermined self-report questions evaluating early signs and symptoms of gingivitis were preliminary assessed by a panel of clinical experts. Eight questions were selected and cognitively tested in 20 adolescents aged 12 to 18 years from Santiago de Chile. The questionnaire was then conducted and answered by 178 Chilean adolescents. Internal consistency was measured using the Cronbach's alpha and temporal stability was calculated using the Kappa-index. A reliable final self-report questionnaire consisting of 5 questions was obtained, with a total Cronbach's alpha of 0.73 and a Kappa-index ranging from 0.41 to 0.77 between the different questions. The proposed questionnaire is reliable, with an acceptable internal consistency and a temporal stability from moderate to substantial, and it is promising for estimating the prevalence of gingivitis in adolescents.

  17. Design and methodology of SNAP-1: a Sprint National Anaesthesia Project to measure patient reported outcome after anaesthesia.

    PubMed

    Moonesinghe, Suneetha Ramani; Walker, Eleanor Mary Kate; Bell, Madeline

    2015-01-01

    Patient satisfaction is an important metric of health-care quality. Accidental awareness under general anaesthesia (AAGA) is a serious complication of anaesthesia care which may go unrecognised in the immediate perioperative period but leads to long-term psychological harm for affected patients. The SNAP-1 study aimed to measure patient satisfaction with anaesthesia care and the incidence of AAGA, reported on direct questioning within 24 h of surgery, in a large multicentre cohort. A secondary aim of SNAP-1 was to test the effectiveness of a new network of Quality Audit and Research Coordinators in NHS anaesthetic departments, to achieve widespread study participation and high patient recruitment rates. This manuscript describes the study methodology. SNAP-1 was a prospective observational cohort study. The study protocol was approved by the National Research Ethics Service. All UK NHS hospitals with anaesthetic departments were invited to participate. Adult patients undergoing any type of non-obstetric surgery were recruited in participating hospitals on 13th and 14th May 2014. Demographic data were collected by anaesthetists providing perioperative care. Patients were then approached within 24 h of surgery to complete two questionnaires-the Bauer patient satisfaction questionnaire (to measure patient reported outcome) and the modified Brice questionnaire (to detect possible accidental awareness). Completion of postoperative questionnaires was taken as evidence of implied consent. Results were recorded on a standard patient case report form, and local investigators entered anonymised data into an electronic database for later analysis by the core research team. Preliminary analyses indicate that over 15,000 patients were recruited across the UK, making SNAP-1 the largest NIHR portfolio-adopted study in anaesthesia to date. Both descriptive and analytic epidemiological analyses will be used to answer specific questions about the patient perception of anaesthesia

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

    PubMed Central

    2012-01-01

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

  19. Feasibility test of a UK-scalable electronic system for regular collection of patient-reported outcome measures and linkage with clinical cancer registry data: the electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) system.

    PubMed

    Ashley, Laura; Jones, Helen; Forman, David; Newsham, Alex; Brown, Julia; Downing, Amy; Velikova, Galina; Wright, Penny

    2011-10-26

    Cancer survivors can face significant physical and psychosocial challenges; there is a need to identify and predict which survivors experience what sorts of difficulties. As highlighted in the UK National Cancer Survivorship Initiative, routine post-diagnostic collection of patient reported outcome measures (PROMs) is required; to be most informative, PROMs must be linked and analysed with patients' diagnostic and treatment information. We have designed and built a potentially cost-efficient UK-scalable electronic system for collecting PROMs via the internet, at regular post-diagnostic time-points, for linking these data with patients' clinical data in cancer registries, and for electronically managing the associated patient monitoring and communications; the electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) system. This study aims to test the feasibility of the ePOCS system, by running it for 2 years in two Yorkshire NHS Trusts, and using the Northern and Yorkshire Cancer Registry and Information Service. Non-metastatic breast, colorectal and prostate cancer patients (largest survivor groups), within 6 months post-diagnosis, will be recruited from hospitals in the Yorkshire Cancer Network. Participants will be asked to complete PROMS, assessing a range of health-related quality-of-life outcomes, at three time-points up to 15 months post-diagnosis, and subsequently to provide opinion on the ePOCS system via a feedback questionnaire. Feasibility will be examined primarily in terms of patient recruitment and retention rates, the representativeness of participating patients, the quantity and quality of collected PROMs data, patients' feedback, the success and reliability of the underpinning informatics, and the system running costs. If sufficient data are generated during system testing, these will be analysed to assess the health-related quality-of-life outcomes reported by patients, and to explore if and how they relate to disease, treatment and

  20. Patient-Reported Outcomes in Latin America: Implementation in Research and Role in Emerging HTA Systems.

    PubMed

    Winnette, Randall; Zárate, Victor; Machnicki, Gerardo; DeMuro, Carla; Gawlicki, Mary; Gnanasakthy, Ari

    2015-12-01

    Patient-reported outcomes (PROs) are increasingly used to demonstrate the value of interventions and support health technology assessment (HTA). The objective of this work was to analyze trends regarding PROs in Latin America (LatAm), highlight challenges in the application of PROs in this region, and suggest solutions. A team of researchers with expertise in PROs conducted a nonsystematic PubMed literature search pertaining to the use of PROs in LatAm. The experts also drew on their experience working with PROs to assess the application of PROs in LatAm. The literature search yielded more than 4000 publications, with an increasing publication rate in recent years. PROs are being used in LatAm in various study types: instrument validation, phase III international clinical trials, health service research. A large Inter-American Development Bank study demonstrates the growing importance of PROs in the region. The growth in local value sets for the EuroQol five-dimensional questionnaire in LatAm reflects the regional emergence of HTA systems. Operational challenges relate to ensuring the use of good-quality questionnaires that, at a minimum, have undergone appropriate cultural adaptation and ideally have established psychometric properties. PROs are increasingly important in LatAm. Future efforts should aim to strengthen the operational and research infrastructure around PROs in the region. Innovation should be encouraged, including studying alternative methods of eliciting health utilities for economic evaluation. A wider scope around PRO uses for decision making by HTA bodies is an international trend with potential positive prospects in LatAm. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  1. The Living with Medicines Questionnaire: Translation and Cultural Adaptation into the Arabic Context.

    PubMed

    Zidan, Amani; Awaisu, Ahmed; Hasan, Sanah; Kheir, Nadir

    2016-09-01

    The Living with Medicines Questionnaire (LMQ) was developed in English language to assess, from a patient's perspective, issues related to the burden resulting from the use of medicines. To translate and culturally adapt the LMQ into the Arabic language and context. Permission to translate the LMQ was obtained from the original developers, and a protocol for its translation and cultural adaptation was developed using the International Society for Pharmacoeconomics and Outcomes Research guidelines for the translation and cultural adaptation of patient-reported outcome measures. Two forward translations (from English into Arabic) were developed and compared to produce the first reconciled version, which was back-translated into English. The resulting English version was compared with the original questionnaire leading to the second reconciled version. The emerged Arabic questionnaire was then cognitively tested among purposively selected individuals to assess the linguistic and cultural equivalence, and produce the final Arabic version. Issues identified and related to cultural and conceptual equivalence of some terms were resolved by rewording some items in the tool. The translation process and cognitive debriefing exercise generated comments regarding the original tool's construct and its Arabic equivalent, which were communicated to the developers of the LMQ for their consideration while conducting further comparative studies. A culturally suitable translation of the LMQ was generated for potential use in research and clinical practice in Arabic-speaking countries. Further validation of the developed Arabic version is recommended and planned. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  2. The Child Play Behavior and Activity Questionnaire: A Parent-Report Measure of Childhood Gender-Related Behavior in China

    PubMed Central

    Winter, Sam; Xie, Dong

    2008-01-01

    Boys and girls establish relatively stable gender stereotyped behavior patterns by middle childhood. Parent-report questionnaires measuring children’s gender-related behavior enable researchers to conduct large-scale screenings of community samples of children. For school-aged children, two parent-report instruments, the Child Game Participation Questionnaire (CGPQ) and the Child Behavior and Attitude Questionnaire (CBAQ), have long been used for measuring children’s sex-dimorphic behaviors in Western societies, but few studies have been conducted using these measures for Chinese populations. The current study aimed to empirically examine and modify the two instruments for their applications to Chinese society. Parents of 486 Chinese boys and 417 Chinese girls (6–12 years old) completed a questionnaire comprising items from the CGPQ and CBAQ, and an additional 14 items specifically related to Chinese gender-specific games. Items revealing gender differences in a Chinese sample were identified and used to construct a Child Play Behavior and Activity Questionnaire (CPBAQ). Four new scales were generated through factor analysis: a Gender Scale, a Girl Typicality Scale, a Boy Typicality Scale, and a Cross-Gender Scale (CGS). These scales had satisfactory internal reliabilities and large effect sizes for gender. The CPBAQ is believed to be a promising instrument for measuring children’s gender-related behavior in China. PMID:18719986

  3. Reporting outcomes of definitive radiation-based treatment for esophageal cancer: a review of the literature.

    PubMed

    Main, B G; Strong, S; McNair, A G; Falk, S J; Crosby, T; Blazeby, J M

    2015-01-01

    Accurate evaluation of radical radiotherapy requires well designed research with valid and appropriate outcomes. This study reviewed standards of outcome reporting and study design in randomized controlled trials (RCTs) of radiation-based therapy for esophageal cancer and made recommendations for future work. Randomized controlled trials reporting outcomes of definitive radiation-based treatment alone or in combination with chemotherapy were systematically identified and summarized. The types, frequency, and definitions of all clinical and patient-reported outcomes (PROs) reported in the methods and results sections of papers were examined. Studies providing a definition for at least one outcome and presenting all outcomes reported in the methods were classified as high quality. From 1425 abstracts, 16 RCTs including 1803 patients were identified. The primary outcome was overall survival in 13 studies, but five different definitions were reported. Outcomes for treatment failure included local, regional, and distant failures, and inconsistent definitions were applied. An observer assessment of dysphagia was reported in seven RCTs but PROs were reported in only one. Only three RCTs were at low risk of bias, with all lacking reports of sequence generation and only a minority reporting allocation concealment. The quality of outcome reporting in RCTs was inconsistent and risked bias. A core outcome set including clinical and PROs is needed to improve reporting of trials of definitive radiation-based treatment for esophageal cancer. © 2014 International Society for Diseases of the Esophagus.

  4. [Outcome Quality in Medical Rehabilitation: Relationship Between "Patient-Reported Outcomes" (PROs) and Social Security Contributions].

    PubMed

    Nübling, R; Kaluscha, R; Krischak, G; Kriz, D; Martin, H; Müller, G; Renzland, J; Reuss-Borst, M; Schmidt, J; Kaiser, U; Toepler, E

    2017-02-01

    Aim of the Study The outcome quality of medical rehabilitation is evaluated often by "Patient Reported Outcomes" (PROs). It is examined to what extent these PROs are corresponding with "hard" or "objective" outcomes such as payments of contributions to social insurance. Methods The "rehabilitation QM outcome study" includes self-reports of patients as well as data from the Rehabilitation Statistics Database (RSD) of the German pension insurance Baden-Wurttemberg. The sample for the question posed includes N=2 947 insured who were treated in 2011 in 21 clinics of the "health quality network" and who were either employed or unemployed at the time of the rehabilitation application (e. g. the workforce or labour force group, response rate: 55%). The sample turned out widely representative for the population of the insured persons. Results PROs and payment of contributions to pension insurance clearly correspond. In the year after the rehabilitation improved vs. not improved rehabilitees differed clearly with regard to their payments of contributions. Conclusions The results support the validity of PROs. For a comprehensive depiction of the outcome quality of rehabilitation PROs and payments of contributions should be considered supplementary. © Georg Thieme Verlag KG Stuttgart · New York.

  5. 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

  6. Postoperative perceived health status in adolescent following idiopathic scoliosis surgical treatment: results using the adapted French version of Scoliosis Research Society Outcomes questionnaire (SRS-22).

    PubMed

    Chaib, Y; Bachy, M; Zakine, S; Mary, P; Khouri, N; Vialle, R

    2013-06-01

    Assessing functional outcome from patient-based outcomes questionnaires are essential to the evaluation of adolescent idiopathic scoliosis surgical treatment At the minimum follow-up of 2 years, 45 operated on adolescent idiopathic scoliosis patients were mailed the French version of the Scoliosis Research Society Outcome Instrument (SRS-22) questionnaires containing items on pain, activities of daily living, and satisfaction. Mean values of the SRS-22 domains were 3,66 for the Pain domain, 3,85 for the Self-perceived image domain, 4,32 for the Function domain, 3,52 for the Mental health domain and 4,12 for the Global satisfaction with management domain. Mean value of the global SRS-22 score was 3,88. We showed no differences in functional SRS-22 health status in patients according to the type of curve (Lenke classification). We showed statistically significant correlations between the gain of Cobb angle and Patients self-image and function domain scores. There was a statistically significant correlation between preoperative Cobb angle and patient satisfaction with management. Even if Function and Self-image scores in our patients are close to control group values, indicating good short to mid-term outcome of surgical treatment, scores for pain and mental health status were significantly lower in patients than controls. Long-term follow-up studies conducted by multiple surgeons over successive generations are mandatory to assess clinical significance of these differences. Level IV. Retrospective study. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  7. Outcome reporting following navigated high tibial osteotomy of the knee: a systematic review.

    PubMed

    Yan, James; Musahl, Volker; Kay, Jeffrey; Khan, Moin; Simunovic, Nicole; Ayeni, Olufemi R

    2016-11-01

    This systematic review evaluates radiographic and clinical outcome reporting following navigated high tibial osteotomy (HTO). Conventional HTO was used as a control to compare outcomes and furthermore investigate the quality of evidence in studies reporting outcomes for navigated HTO. It was hypothesized that navigated HTO will show superior clinical and radiographic outcomes compared to conventional HTO. Two independent reviewers searched PubMed, Ovid (MEDLINE), EMBASE, and Cochrane databases for studies reporting outcomes following navigated HTO. Titles, abstracts, and full-text were screened in duplicate using an a priori inclusion and exclusion criteria. Descriptive statistics were calculated using Minitab ® statistical software. Methodological Index for Nonrandomized Studies (MINORS) and Cochrane Risk of Bias Scores were used to evaluate methodological quality. Thirty-four studies which involved 2216 HTOs were analysed in this review, 1608 (72.6 %) navigated HTOs and 608 (27.4 %) conventional HTOs. The majority of studies were of level IV evidence (16). Clinical outcomes were reported in knee and function scores or range of motion comparisons. Postoperative clinical and functional scores were improved by navigated HTO although it is not demonstrated if there is significant improvement compared to conventional HTO. Most common clinical outcome score reported was Lysholm scores (6) which report postoperative scores of 87.8 (standard deviation 5.9) and 88.8 (standard deviation 5.9) for conventional and navigation-assisted HTO, respectively. Radiographic outcomes reported commonly were weight-bearing mechanical axis, coronal plane angle, and posterior tibial slope angle in the sagittal plane. Studies have shown HTO gives significant correction of mechanical alignment and navigated HTO produces significantly less change in posterior tibial slope postoperatively compared to conventional. The mean MINORS for the 17 non-comparative studies was 9/16, and 15/24 for

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

    PubMed

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

    2015-09-01

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

  9. Standardizing patient-reported outcomes assessment in cancer clinical trials: a patient-reported outcomes measurement information system initiative.

    PubMed

    Garcia, Sofia F; Cella, David; Clauser, Steven B; Flynn, Kathryn E; Lad, Thomas; Lai, Jin-Shei; Reeve, Bryce B; Smith, Ashley Wilder; Stone, Arthur A; Weinfurt, Kevin

    2007-11-10

    Patient-reported outcomes (PROs), such as symptom scales or more broad-based health-related quality-of-life measures, play an important role in oncology clinical trials. They frequently are used to help evaluate cancer treatments, as well as for supportive and palliative oncology care. To be most beneficial, these PROs must be relevant to patients and clinicians, valid, and easily understood and interpreted. The Patient-Reported Outcomes Measurement Information System (PROMIS) Network, part of the National Institutes of Health Roadmap Initiative, aims to improve appreciably how PROs are selected and assessed in clinical research, including clinical trials. PROMIS is establishing a publicly available resource of standardized, accurate, and efficient PRO measures of major self-reported health domains (eg, pain, fatigue, emotional distress, physical function, social function) that are relevant across chronic illnesses including cancer. PROMIS is also developing measures of self-reported health domains specifically targeted to cancer, such as sleep/wake function, sexual function, cognitive function, and the psychosocial impacts of the illness experience (ie, stress response and coping; shifts in self-concept, social interactions, and spirituality). We outline the qualitative and quantitative methods by which PROMIS measures are being developed and adapted for use in clinical oncology research. At the core of this activity is the formation and application of item banks using item response theory modeling. We also present our work in the fatigue domain, including a short-form measure, as a sample of PROMIS methodology and work to date. Plans for future validation and application of PROMIS measures are discussed.

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

    PubMed

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

    2011-12-01

    The present study aimed to investigate associations of both parent-reported and child-perceived parenting styles and parent-reported parenting practices with child weight and weight-related behaviours. Participants were 175 children (56% female) aged between 7 and 11, and their primary caregivers (91% female), recruited through South Australian primary schools. Children completed measures of parenting style, attitude toward fruit, vegetables, and non-core food, and attraction to physical activity. Parents completed measures of parenting style and domain-specific parenting practices (feeding and activity-related practices) and reported on child dietary intake, physical activity, and sedentary behaviour. Objective height and weight measurements were taken from children, from which body mass index (BMI) was calculated. Child-reported parenting style and parent-reported parenting practices were uniquely associated with child weight-related outcomes, but styles and practices did not interact in their association with child outcomes. Child-reported parenting style was associated with child food and activity attitudes, whereas parent-reported parenting style was not associated with child outcomes. The findings of the present study generally support the recommendation of a parenting style high in demandingness and responsiveness for supporting healthy child weight-related behaviours, along with appropriate domain-specific practices. The child's perspective should be incorporated into research involving child outcomes wherever possible. Crown Copyright © 2011. Published by Elsevier Ltd. All rights reserved.

  11. Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM).

    PubMed

    McNamara, Robert L; Spatz, Erica S; Kelley, Thomas A; Stowell, Caleb J; Beltrame, John; Heidenreich, Paul; Tresserras, Ricard; Jernberg, Tomas; Chua, Terrance; Morgan, Louise; Panigrahi, Bishnu; Rosas Ruiz, Alba; Rumsfeld, John S; Sadwin, Lawrence; Schoeberl, Mark; Shahian, David; Weston, Clive; Yeh, Robert; Lewin, Jack

    2015-05-19

    Coronary artery disease (CAD) outcomes consistently improve when they are routinely measured and provided back to physicians and hospitals. However, few centers around the world systematically track outcomes, and no global standards exist. Furthermore, patient-centered outcomes and longitudinal outcomes are under-represented in current assessments. The nonprofit International Consortium for Health Outcomes Measurement (ICHOM) convened an international Working Group to define a consensus standard set of outcome measures and risk factors for tracking, comparing, and improving the outcomes of CAD care. Members were drawn from 4 continents and 6 countries. Using a modified Delphi method, the ICHOM Working Group defined who should be tracked, what should be measured, and when such measurements should be performed. The ICHOM CAD consensus measures were designed to be relevant for all patients diagnosed with CAD, including those with acute myocardial infarction, angina, and asymptomatic CAD. Thirteen specific outcomes were chosen, including acute complications occurring within 30 days of acute myocardial infarction, coronary artery bypass grafting surgery, or percutaneous coronary intervention; and longitudinal outcomes for up to 5 years for patient-reported health status (Seattle Angina Questionnaire [SAQ-7], elements of Rose Dyspnea Score, and Patient Health Questionnaire [PHQ-2]), cardiovascular hospital admissions, cardiovascular procedures, renal failure, and mortality. Baseline demographic, cardiovascular disease, and comorbidity information is included to improve the interpretability of comparisons. ICHOM recommends that this set of outcomes and other patient information be measured for all patients with CAD. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-01-01

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

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

    PubMed

    Silveira, Augusta P; Gonçalves, Joaquim; Sequeira, Teresa; Ribeiro, Cláudia; Lopes, Carlos; Monteiro, Eurico; Pimentel, Francisco L

    2010-10-31

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

  15. Building Bridges Using the Shriners Hospitals for Children/American Burn Association Burn Outcome Questionnaires to Follow Teenagers and Young Adults Across the Age Spans.

    PubMed

    Kaat, Aaron J; Chen, Liang; Kazis, Lewis E; Lee, Austin F; Shapiro, Gabriel D; Sheridan, Robert L; Ryan, Colleen M; Schneider, Jeffrey C

    2017-05-04

    The Shriners Hospitals for Children/American Burn Association Burn Outcomes Questionnaires (BOQ) are well-established, reliable, and valid outcome measures. The adolescent (BOQ11-18 years) and young adult version (18-30 years) have similar overlapping domains, but the scores are not comparable. This study objective was to build bridges across these forms. Datasets were from the Multi-Center Benchmarking Study Group. The comparable subscales from the BOQ11-18 and the young adult version were bridged using item response theory cocalibration. The item response theory scale scores were then transformed into an expected raw score on the alternative form, from which normative scores are available. A sensitivity analysis using up to three time points, as opposed to one randomly selected occasion, was also conducted to ensure robust results. Data were available on 353 unique adolescents and 148 young adults. The comparable subscales were successfully bridged across forms (adolescent reliability from 0.67 to 0.85; young adult from 0.69 to 0.88). Compared with adolescents, young adults on average reported more pain and itch, less symptom and role satisfaction, and poorer work/school reintegration (Cohen's d = 0.39-0.77; P < .05). Physical functioning, appearance, and family/parental concern were comparable across ages (d = -0.01 to 0.09; P > .05). Family functioning was better for young adults than adolescents (d = -0.25; P = .006). BOQ11-18 scores can be mapped from adolescence into young adulthood. Physical and psychosocial outcomes change across this life span. Bridges provide a highly useful approach to track changes across this part of the lifespan.

  16. Use of patient-reported outcome measures in foot and ankle research.

    PubMed

    Hunt, Kenneth J; Hurwit, Daniel

    2013-08-21

    In the orthopaedic literature, there is a wide range of clinical outcome measurement tools that have been used in evaluating foot and ankle procedures, disorders, and outcomes, with no broadly accepted consensus as to which tools are preferred. The purpose of this study was to determine the frequency and distribution of the various outcome instruments used in the foot and ankle literature, and to identify trends for use of these instruments over time. We conducted a systematic review of all original clinical articles reporting on foot and/or ankle topics in six orthopaedic journals over a ten-year period (2002 to 2011). All clinical patient-reported outcome rating instruments used in these articles were recorded, as were study date, study design, clinical topic, and level of evidence. A total of 878 clinical foot and ankle articles that used at least one patient-reported outcome measure were identified among 16,513 total articles published during the ten-year period. There were 139 unique clinical outcome scales used, and the five most popular scales (as a percentage of foot/ankle outcome articles) were the American Orthopaedic Foot & Ankle Society (AOFAS) scales (55.9%), visual analog scale (VAS) for pain (22.9%), Short Form-36 (SF-36) Health Survey (13.7%), Foot Function Index (FFI) (5.5%), and American Academy of Orthopaedic Surgeons (AAOS) outcomes instruments (3.3%). The majority of articles described Level-IV studies (70.1%); only 9.4% reported Level-I studies. A considerable variety of outcome measurement tools are used in the foot and ankle clinical literature, with a small proportion used consistently. The AOFAS scales continue to be used at a high rate relative to other scales that have been validated. Data from the present study underscore the need for a paradigm shift toward the use of consistent, valid, and reliable outcome measures for studies of foot and ankle procedures and disorders. It is not clear which existing validated outcome instruments will

  17. Phase III development of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire module for women undergoing breast reconstruction.

    PubMed

    Winters, Z E; Balta, V; Thomson, H J; Brandberg, Y; Oberguggenberger, A; Sinove, Y; Unukovych, D; Nava, M; Sandelin, K; Johansson, H; Dobbeleir, J; Blondeel, P; Bruno, N; Catanuto, G; Llewellyn-Bennett, R

    2014-03-01

    Comprehensive outcome assessments after breast reconstruction (BRR) require surgery-specific patient-reported outcome measures. The aims of this study were to assess the relevance, acceptability and redundancy of questions/items (phase III pretesting) of a new BRR questionnaire evaluating patients' health-related quality of life before and after BRR. Phase III occurred in collaboration with the European Organization for Research and Treatment of Cancer (EORTC) following earlier development phases that identified 31 items. The EORTC BRR subgroup applied decision-making rules to each question according to eight EORTC criteria. A total of 197 patients (from the UK, Austria, Belgium, Italy and Sweden) were recruited. Forty-seven patients completed pre- and post-BRR questionnaires prospectively, and 150 reported post-BRR questionnaires only retrospectively. Qualitative debriefing interviews were undertaken in 189 patients. Preliminary psychometric analyses were performed. Thirty-one items fulfilled 'relevance', with none producing 'difficulties'. Ten items were not a priority for 10 per cent of respondents. Of these, two questions concerning muscle twitching in the affected breast and problem with donor-site swelling were deleted. Three redundant items were deleted: weakness in arm, which correlated significantly to the Quality of Life Questionnaire (QLQ) BR23 breast questionnaire, and shape and colour of the affected nipple. Descriptive statistics reduced the module to 26 items conceptualized into three provisional scales (disease treatment/surgery-related symptoms, sexuality and cosmetic outcome) within the newly completed questionnaire, EORTC QLQ-BRR26. The QLQ-BRR26 is available for psychometric validation in a large-field international sample. The intended use for QLQ-BRR26 is alongside EORTC QLQ-C30 and QLQ-BR23, in women treated by mastectomy for breast cancer and undergoing all types of BRR. © 2014 BJS Society Ltd. Published by John Wiley & Sons Ltd.

  18. Outcomes Reported by Spanish-Speaking Families in Early Intervention

    ERIC Educational Resources Information Center

    Olmsted, Murrey G.; Bailey, Donald B., Jr.; Raspa, Melissa; Nelson, Robin E.; Robinson, Nyle D.; Simpson, Mary Ellen; Guillen, Chelsea

    2010-01-01

    In this study, the authors use data from two states to compare how families participating in early intervention who completed a Spanish version of the Family Outcomes Survey (FOS) (n = 291) compared with Hispanic (n = 486) and non-Hispanic (n = 2,363) families who completed the English version. In general, most families reported positive outcomes,…

  19. Patient-reported outcomes following parotid-sparing intensity-modulated radiotherapy for head and neck cancer. How important is dysphagia?

    PubMed

    Roe, Justin W G; Drinnan, Michael J; Carding, Paul N; Harrington, Kevin J; Nutting, Christopher M

    2014-12-01

    Swallowing can be significantly affected during and following radiotherapy for head and neck cancer (HNC). The purpose of this study was to understand: (1) the trajectory of swallowing recovery following parotid-sparing intensity-modulated radiotherapy (IMRT) and (2) overall physical and social-emotional wellbeing and how patients prioritise swallowing following treatment. Sixty-one HNC patients completed questionnaires as part of a prospective study exploring patient-reported swallowing outcomes following parotid-sparing IMRT. Participants were asked to complete the M.D. Anderson Dysphagia Inventory (MDADI) and University of Washington Quality of Life Questionnaire (UW-QoL) v.04 before treatment and 3, 6 and 12months after treatment. Given the rise in human papilloma virus (HPV) and associated oropharyngeal cancers, we completed a sub analysis of the data in those participants. There was a significant reduction in the MDADI composite scores 3months after completion of treatment. Improvements were observed by 12months, however, scores did not recover to baseline. The recovery in physical function was limited in comparison to social-emotional recovery at 12months. When oropharyngeal cancer scores were analysed, there was not a substantial difference to the whole group results. There was a shift in priorities following treatment. Swallowing was highlighted as a concern by 44% of HNC patients up to 12months after treatment with swallowing-related factors (saliva, taste and chewing) rated highly. Patient reported swallowing outcomes were significantly affected from baseline to all follow-up time points and remained a priority concern at 12months following treatment. Overall social-emotional functioning does improve, suggesting that patients have the potential to adapt to their "new normal" following IMRT for HNC. Copyright © 2014 Elsevier Ltd. All rights reserved.

  20. 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.

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

    PubMed Central

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

    2017-01-01

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

  2. Development of a self-report questionnaire designed for population-based surveillance of gingivitis in adolescents: assessment of content validity and reliability

    PubMed Central

    QUIROZ, Viviana; REINERO, Daniela; HERNÁNDEZ, Patricia; CONTRERAS, Johanna; VERNAL, Rolando; CARVAJAL, Paola

    2017-01-01

    Abstract The major infectious diseases in Chile encompass the periodontal diseases, with a combined prevalence that rises up to 90% of the population. Thus, the population-based surveillance of periodontal diseases plays a central role for assessing their prevalence and for planning, implementing, and evaluating preventive and control programs. Self-report questionnaires have been proposed for the surveillance of periodontal diseases in adult populations world-wide. Objective This study aimed to develop and assess the content validity and reliability of a cognitively adapted self-report questionnaire designed for surveillance of gingivitis in adolescents. Material and Methods Ten predetermined self-report questions evaluating early signs and symptoms of gingivitis were preliminary assessed by a panel of clinical experts. Eight questions were selected and cognitively tested in 20 adolescents aged 12 to 18 years from Santiago de Chile. The questionnaire was then conducted and answered by 178 Chilean adolescents. Internal consistency was measured using the Cronbach’s alpha and temporal stability was calculated using the Kappa-index. Results A reliable final self-report questionnaire consisting of 5 questions was obtained, with a total Cronbach’s alpha of 0.73 and a Kappa-index ranging from 0.41 to 0.77 between the different questions. Conclusions The proposed questionnaire is reliable, with an acceptable internal consistency and a temporal stability from moderate to substantial, and it is promising for estimating the prevalence of gingivitis in adolescents. PMID:28877279

  3. Application of the Smokeless Tobacco Expectancies Questionnaire to Snus

    PubMed Central

    Adkison, Sarah E.; Bansal-Travers, Maansi; Rees, Vaughan W.; Hatuskami, Dorothy K.; Cummings, K. Michael; O'Connor, Richard J.

    2016-01-01

    Objective Measures of consumer perceptions of emerging tobacco products are needed for understanding the potential for product adoption and use. The purpose of this research was to evaluate the applicability of the Smokeless Tobacco Expectancies questionnaire to snus, and examine its association with interest in using snus. Methods A web-based recruited 116 adolescents (14-17 years of age), 463 young adults (18-34 years of age), and 596 older adults (35-65 years of age) from a web-based opt-in panel. Participants completed a 10-item Snus Expectancies Questionnaire and questions about their interest in trying snus in the next month. Results Confirmatory factor analysis supported a latent factor structure representing Positive Reinforcement (PR) and Negative Health Consequences (NHC) within each age group. The scales differentiate smokers and smokeless tobacco users and nonusers. Each scale was associated with interest in purchasing snus for younger (PR: OR 1.90; NHC: OR 0.66) and older (PR: OR 1.36; NHC: OR 0.69) adults controlling for tobacco use status. Conclusions The modified Smokeless Tobacco Expectancies Questionnaire is a valid measure of snus-related outcome expectancies, which are in turn associated with self-reported tobacco use, and may help to identify groups who are susceptible to snus initiation and use. PMID:27561868

  4. Clinical Application and Psychometric Properties of a Norwegian Questionnaire for the Self-Assessment of Communication in Quiet and Adverse Conditions Using Two Revised APHAB Subscales.

    PubMed

    Heggdal, Peder O Laugen; Nordvik, Øyvind; Brännström, Jonas; Vassbotn, Flemming; Aarstad, Anne Kari; Aarstad, Hans Jørgen

    2018-01-01

    Difficulty in following and understanding conversation in different daily life situations is a common complaint among persons with hearing loss. To the best of our knowledge, there is currently no published validated Norwegian questionnaire available that allows for a self-assessment of unaided communication ability in a population with hearing loss. The aims of the present study were to investigate a questionnaire for the self-assessment of communication ability, examine the psychometric properties of this questionnaire, and explore how demographic variables such as degree of hearing loss, age, and sex influence response patterns. A questionnaire based on the subscales of the Norwegian translation of the Abbreviated Profile of Hearing Aid Benefit was applied to a group of hearing aid users and normal-hearing controls. A total of 108 patients with bilateral hearing loss, and 101 controls with self-reported normal hearing. The psychometric properties were evaluated. Associations and differences between outcome scores and descriptive variables were examined. A regression analysis was performed to investigate whether descriptive variables could predict outcome. The measures of reliability suggest that the questionnaire has satisfactory psychometric properties, with the outcome of the questionnaire correlating to hearing loss severity, thus indicating that the concurrent validity of the questionnaire is good. The findings indicate that the proposed questionnaire is a valid measure of self-assessed communication ability in both quiet and adverse listening conditions in participants with and without hearing loss. American Academy of Audiology

  5. Hand eczema among Hong Kong nurses: a self-report questionnaire survey conducted in a regional hospital.

    PubMed

    Luk, Nai-Ming T; Lee, Hau-Chi S; Luk, Chi-Kong D; Cheung, Yuk-Yin A; Chang, Mang-Chi; Chao, Vai-Kiong D; Ng, Shun-Chin; Tang, Leung-Sang N

    2011-12-01

    Hand eczema is common in the nursing profession, and has been reported widely in various parts of the world. The aim of this study was to determine the prevalence and severity of hand eczema among nurses working in a regional hospital in Hong Kong, as well as its psychosocial impact and any possible associated risk factors. The study took the form of a self-report questionnaire survey; 1240 nurses in a regional hospital were asked to participate in the survey by completing the questionnaire and returning it anonymously within 2 weeks. Seven hundred and twenty-four nurses returned the questionnaire (a response rate of 59%). The prevalence of hand eczema among the respondents was 22.1% (160/724). More than 90% had moderate to severe hand eczema. Itchiness and dryness were the most common symptoms. Occupational work, housework, mood, social activities and sleep were particularly affected. Multinomial logistic regressions showed that a personal or family history of atopy and a hand washing frequency of >20 times per day were independent risk factors for hand eczema. Hand eczema is common and severe among Hong Kong nurses. The results of this study suggest that hand eczema is an important problem for nurses and that preventive measures should be emphasized. © 2011 John Wiley & Sons A/S.

  6. Validation study of the Forgotten Joint Score-12 as a universal patient-reported outcome measure.

    PubMed

    Matsumoto, Mikio; Baba, Tomonori; Homma, Yasuhiro; Kobayashi, Hideo; Ochi, Hironori; Yuasa, Takahito; Behrend, Henrik; Kaneko, Kazuo

    2015-10-01

    The Forgotten Joint Score-12 (FJS-12) is for patients to forget their artificial joint and is reportedly a useful patient-reported outcome tool for artificial joints. The purpose of this study was to determine whether the FJS-12 is as useful as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) or the Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ) in Japan. All patients who visited our hospital's hip joint specialists following unilateral THA from August 2013 to July 2014 were evaluated. Medical staff members other than physicians administered three questionnaires. Items evaluated were (1) the reliability of the FJS-12 and (2) correlations between the FJS-12 and the total and subscale scores of the WOMAC or JHEQ. Of 130 patients, 22 were excluded. Cronbach's α coefficient was 0.97 for the FJS-12. The FJS-12 showed a significantly lower score than the WOMAC or JHEQ (p < 0.01). The FJS-12 was moderately correlated with the total WOMAC score (r = 0.522) and its subscale scores for "stiffness" (r = 0.401) and "function" (r = 0.539) and was weakly correlated with the score for "pain" (r = 0.289). The FJS-12 was favorably correlated with the total JHEQ score (r = 0.686) and its subscale scores (r = 0.530-0.643). The FJS-12 was correlated with and showed reliability similar to that of the JHEQ and WOMAC. The FJS-12, which is not affected by culture or lifestyle, may be useful in Japan.

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

    PubMed

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

    2010-12-01

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

  8. The utility of abbreviated patient-reported outcomes for predicting survival in early stage colorectal cancer.

    PubMed

    Hsu, Tina; Speers, Caroline H; Kennecke, Hagen F; Cheung, Winson Y

    2017-05-15

    Patient-reported outcomes (PROs) are increasingly used in clinical settings. Prior research suggests that PROs collected at baseline may be associated with cancer survival, but most of those studies were conducted in patients with breast or lung cancer. The objective of this study was to determine the correlation between prospectively collected PROs and cancer-specific outcomes in patients with early stage colorectal cancer. Patients who had newly diagnosed stage II or III colorectal cancer from 2009 to 2010 and had a consultation at the British Columbia Cancer Agency completed the brief Psychosocial Screen for Cancer (PSSCAN) questionnaire, which collects data on patients' perceived social supports, quality of life (QOL), anxiety and depression, and general health. PROs from the PSSCAN were linked with the Gastrointestinal Cancers Outcomes Database, which contains information on patient and tumor characteristics, treatment details, and cancer outcomes. Cox regression models were constructed for overall survival (OS), and Fine and Gray regression models were developed for disease-specific survival (DSS). In total, 692 patients were included. The median patient age was 67 years (range, 26-95 years), and the majority had colon cancer (61%), were diagnosed with stage III disease (54%), and received chemotherapy (58%). In general, patients felt well supported and reported good overall health and QOL. On multivariate analysis, increased fatigue was associated with worse OS (hazard ratio [HR], 1.99; P = .00007) and DSS (HR, 1.63; P = .03), as was lack of emotional support (OS: HR, 4.36; P = .0003; DSS: HR, 1.92; P = .02). Although most patients described good overall health and QOL and indicated that they were generally well supported, patients who experienced more pronounced fatigue or lacked emotional support had a higher likelihood of worse OS and DSS. These findings suggest that abbreviated PROs can inform and assist clinicians to identify patients who have a worse

  9. Reliability and validity of two multidimensional self-reported physical activity questionnaires in people with chronic low back pain.

    PubMed

    Carvalho, Flávia A; Morelhão, Priscila K; Franco, Marcia R; Maher, Chris G; Smeets, Rob J E M; Oliveira, Crystian B; Freitas Júnior, Ismael F; Pinto, Rafael Z

    2017-02-01

    Although there is some evidence for reliability and validity of self-report physical activity (PA) questionnaires in the general adult population, it is unclear whether we can assume similar measurement properties in people with chronic low back pain (LBP). To determine the test-retest reliability of the International Physical Activity Questionnaire (IPAQ) long-version and the Baecke Physical Activity Questionnaire (BPAQ) and their criterion-related validity against data derived from accelerometers in patients with chronic LBP. Cross-sectional study. Patients with non-specific chronic LBP were recruited. Each participant attended the clinic twice (one week interval) and completed self-report PA. Accelerometer measures >7 days included time spent in moderate-and-vigorous physical activity, steps/day, counts/minute, and vector magnitude counts/minute. Intraclass Correlation Coefficients (ICC) and Bland and Altman method were used to determine reliability and spearman rho correlation were used for criterion-related validity. A total of 73 patients were included in our analyses. The reliability analyses revealed that the BPAQ and its subscales have moderate to excellent reliability (ICC 2,1 : 0.61 to 0.81), whereas IPAQ and most IPAQ domains (except walking) showed poor reliability (ICC 2,1 : 0.20 to 0.40). The Bland and Altman method revealed larger discrepancies for the IPAQ. For the validity analysis, questionnaire and accelerometer measures showed at best fair correlation (rho < 0.37). Although the BPAQ showed better reliability than the IPAQ long-version, both questionnaires did not demonstrate acceptable validity against accelerometer data. These findings suggest that questionnaire and accelerometer PA measures should not be used interchangeably in this population. Copyright © 2016 Elsevier Ltd. All rights reserved.

  10. Systematic review: Outcome reporting bias is a problem in high impact factor neurology journals

    PubMed Central

    Scott, Jared T.; Blubaugh, Mark; Roepke, Brie; Scheckel, Caleb; Vassar, Matt

    2017-01-01

    Background Selective outcome reporting is a significant methodological concern. Comparisons between the outcomes reported in clinical trial registrations and those later published allow investigators to understand the extent of selection bias among trialists. We examined the possibility of selective outcome reporting in randomized controlled trials (RCTs) published in neurology journals. Methods We searched PubMed for randomized controlled trials from Jan 1, 2010 –Dec 31, 2015 published in the top 3 impact factor neurology journals. These articles were screened according to specific inclusion criteria. Each author individually extracted data from trials following a standardized protocol. A second author verified each extracted element and discrepancies were resolved. Consistency between registered and published outcomes was evaluated and correlations between discrepancies and funding, journal, and temporal trends were examined. Results 180 trials were included for analysis. 10 (6%) primary outcomes were demoted, 38 (21%) primary outcomes were omitted from the publication, and 61 (34%) unregistered primary outcomes were added to the published report. There were 18 (10%) cases of secondary outcomes being upgraded to primary outcomes in the publication, and there were 53 (29%) changes in timing of assessment. Of 82 (46%) major discrepancies with reported p-values, 54 (66.0%) favored publication of statistically significant results. Conclusion Across trials, we found 180 major discrepancies. 66% of major discrepancies with a reported p-value (n = 82) favored statistically significant results. These results suggest a need within neurology to provide more consistent and timely registration of outcomes. PMID:28727834

  11. Systematic review: Outcome reporting bias is a problem in high impact factor neurology journals.

    PubMed

    Howard, Benjamin; Scott, Jared T; Blubaugh, Mark; Roepke, Brie; Scheckel, Caleb; Vassar, Matt

    2017-01-01

    Selective outcome reporting is a significant methodological concern. Comparisons between the outcomes reported in clinical trial registrations and those later published allow investigators to understand the extent of selection bias among trialists. We examined the possibility of selective outcome reporting in randomized controlled trials (RCTs) published in neurology journals. We searched PubMed for randomized controlled trials from Jan 1, 2010 -Dec 31, 2015 published in the top 3 impact factor neurology journals. These articles were screened according to specific inclusion criteria. Each author individually extracted data from trials following a standardized protocol. A second author verified each extracted element and discrepancies were resolved. Consistency between registered and published outcomes was evaluated and correlations between discrepancies and funding, journal, and temporal trends were examined. 180 trials were included for analysis. 10 (6%) primary outcomes were demoted, 38 (21%) primary outcomes were omitted from the publication, and 61 (34%) unregistered primary outcomes were added to the published report. There were 18 (10%) cases of secondary outcomes being upgraded to primary outcomes in the publication, and there were 53 (29%) changes in timing of assessment. Of 82 (46%) major discrepancies with reported p-values, 54 (66.0%) favored publication of statistically significant results. Across trials, we found 180 major discrepancies. 66% of major discrepancies with a reported p-value (n = 82) favored statistically significant results. These results suggest a need within neurology to provide more consistent and timely registration of outcomes.

  12. Washington State's model of physician leadership in cardiac outcomes reporting.

    PubMed

    Goss, J R; Whitten, R W; Phillips, R C; Johnston, G G; Hofer, B O; Mansfield, P B; Tidwell, S L; Spertus, J A; LoGerfo, J P

    2000-09-01

    In 1993, the cardiac surgery community in Washington State opposed an effort by the state Health Care Authority (HCA) to identify "centers of excellence" for selective contracting of coronary artery bypass grafting (CABG) procedures, and proposed an alternate model that would create a statewide cardiac outcomes registry under physician governance to be used by all institutions for internal quality improvement activities. A prospective pilot data collection effort, which examined preoperative and postoperative patient-reported health status, served as the basis for evaluating the capacity of a physician-led organization to develop a collaborative atmosphere and facilitate universal hospital participation. A surgical steering group met on a regular basis and reached consensus on governance issues, protocols for standardized data collection, and policies regarding data dissemination. All 14 centers that performed bypass surgery in the state participated. Patients who were surveyed reported statistically significant improvements in physical, emotional, and anginal-specific health status after bypass surgery. Baseline patient characteristics and longitudinal outcomes were compared across institutions. Based on the feasibility of this collaborative outcomes reporting program, the HCA revised its policy regarding selective contracting and has helped to support an ongoing physician-led and -governed cardiac outcomes reporting system that is particularly notable for the subsequent integration of both CABG surgery and catheterization-based procedures into one standardized registry.

  13. Reliability and Construct Validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Instruments in Women with Fibromyalgia.

    PubMed

    Merriwether, Ericka N; Rakel, Barbara A; Zimmerman, Miriam B; Dailey, Dana L; Vance, Carol G T; Darghosian, Leon; Golchha, Meenakshi; Geasland, Katherine M; Chimenti, Ruth; Crofford, Leslie J; Sluka, Kathleen A

    2017-08-01

    The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to standardize measurement of clinically relevant patient-reported outcomes. This study evaluated the reliability and construct validity of select PROMIS static short-form (SF) instruments in women with fibromyalgia. Analysis of baseline data from the Fibromyalgia Activity Study with TENS (FAST), a randomized controlled trial of the efficacy of transcutaneous electrical nerve stimulation. Dual site, university-based outpatient clinics. Women aged 20 to 67 years diagnosed with fibromyalgia. Participants completed the Revised Fibromyalgia Impact Questionnaire (FIQR) and 10 PROMIS static SF instruments. Internal consistency was calculated using Cronbach alpha. Convergent validity was examined against the FIQR using Pearson correlation and multiple regression analysis. PROMIS static SF instruments had fair to high internal consistency (Cronbach α = 0.58 to 0.94, P  < 0.05). PROMIS 'physical function' domain score was highly correlated with FIQR 'function' score (r = -0.73). The PROMIS 'total' score was highly correlated with the FIQR total score (r = -0.72). Correlations with FIQR total score of each of the three PROMIS domain scores were r = -0.65 for 'physical function,' r = -0.63 for 'global,' and r = -0.57 for 'symptom' domain. PROMIS 'physical function,' 'global,' and 'symptom' scores explained 58% of the FIQR total score variance. Select PROMIS static SF instruments demonstrate convergent validity with the FIQR, a legacy measure of fibromyalgia disease severity. These results highlight the potential utility of select PROMIS static SFs for assessment and tracking of patient-reported outcomes in fibromyalgia. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  14. The Cervical Dystonia Impact Profile (CDIP-58): Can a Rasch developed patient reported outcome measure satisfy traditional psychometric criteria?

    PubMed Central

    Cano, Stefan J; Warner, Thomas T; Thompson, Alan J; Bhatia, Kailash P; Fitzpatrick, Ray; Hobart, Jeremy C

    2008-01-01

    Background The United States Food and Drug Administration (FDA) are currently producing guidelines for the scientific adequacy of patient reported outcome measures (PROMs) in clinical trials, which will have implications for the selection of scales used in future clinical trials. In this study, we examine how the Cervical Dystonia Impact Profile (CDIP-58), a rigorous Rasch measurement developed neurologic PROM, stands up to traditional psychometric criteria for three reasons: 1) provide traditional psychometric evidence for the CDIP-58 in line with proposed FDA guidelines; 2) enable researchers and clinicians to compare it with existing dystonia PROMs; and 3) help researchers and clinicians bridge the knowledge gap between old and new methods of reliability and validity testing. Methods We evaluated traditional psychometric properties of data quality, scaling assumptions, targeting, reliability and validity in a group of 391 people with CD. The main outcome measures used were the CDIP-58, Medical Outcome Study Short Form-36, the 28-item General Health Questionnaire, and Hospital and Anxiety and Depression Scale. Results A total of 391 people returned completed questionnaires (corrected response rate 87%). Analyses showed: 1) data quality was high (low missing data ≤ 4%, subscale scores could be computed for > 96% of the sample); 2) item groupings passed tests for scaling assumptions; 3) good targeting (except for the Sleep subscale, ceiling effect = 27%); 4) good reliability (Cronbach's alpha ≥ 0.92, test-retest intraclass correlations ≥ 0.83); and 5) validity was supported. Conclusion This study has shown that new psychometric methods can produce a PROM that stands up to traditional criteria and supports the clinical advantages of Rasch analysis. PMID:18684327

  15. The cervical dystonia impact profile (CDIP-58): can a Rasch developed patient reported outcome measure satisfy traditional psychometric criteria?

    PubMed

    Cano, Stefan J; Warner, Thomas T; Thompson, Alan J; Bhatia, Kailash P; Fitzpatrick, Ray; Hobart, Jeremy C

    2008-08-06

    The United States Food and Drug Administration (FDA) are currently producing guidelines for the scientific adequacy of patient reported outcome measures (PROMs) in clinical trials, which will have implications for the selection of scales used in future clinical trials. In this study, we examine how the Cervical Dystonia Impact Profile (CDIP-58), a rigorous Rasch measurement developed neurologic PROM, stands up to traditional psychometric criteria for three reasons: 1) provide traditional psychometric evidence for the CDIP-58 in line with proposed FDA guidelines; 2) enable researchers and clinicians to compare it with existing dystonia PROMs; and 3) help researchers and clinicians bridge the knowledge gap between old and new methods of reliability and validity testing. We evaluated traditional psychometric properties of data quality, scaling assumptions, targeting, reliability and validity in a group of 391 people with CD. The main outcome measures used were the CDIP-58, Medical Outcome Study Short Form-36, the 28-item General Health Questionnaire, and Hospital and Anxiety and Depression Scale. A total of 391 people returned completed questionnaires (corrected response rate 87%). Analyses showed: 1) data quality was high (low missing data < or = 4%, subscale scores could be computed for > 96% of the sample); 2) item groupings passed tests for scaling assumptions; 3) good targeting (except for the Sleep subscale, ceiling effect = 27%); 4) good reliability (Cronbach's alpha > or = 0.92, test-retest intraclass correlations > or = 0.83); and 5) validity was supported. This study has shown that new psychometric methods can produce a PROM that stands up to traditional criteria and supports the clinical advantages of Rasch analysis.

  16. Measuring voice outcomes: state of the science review.

    PubMed

    Carding, Pau N; Wilson, J A; MacKenzie, K; Deary, I J

    2009-08-01

    Researchers evaluating voice disorder interventions currently have a plethora of voice outcome measurement tools from which to choose. Faced with such a wide choice, it would be beneficial to establish a clear rationale to guide selection. This article reviews the published literature on the three main areas of voice outcome assessment: (1) perceptual rating of voice quality, (2) acoustic measurement of the speech signal and (3) patient self-reporting of voice problems. We analysed the published reliability, validity, sensitivity to change and utility of the common outcome measurement tools in each area. From the data, we suggest that routine voice outcome measurement should include (1) an expert rating of voice quality (using the Grade-Roughness-Breathiness-Asthenia-Strain rating scale) and (2) a short self-reporting tool (either the Vocal Performance Questionnaire or the Vocal Handicap Index 10). These measures have high validity, the best reported reliability to date, good sensitivity to change data and excellent utility ratings. However, their application and administration require attention to detail. Acoustic measurement has arguable validity and poor reliability data at the present time. Other areas of voice outcome measurement (e.g. stroboscopy and aerodynamic phonatory measurements) require similarly detailed research and analysis.

  17. Should English healthcare providers be penalised for failing to collect patient-reported outcome measures? A retrospective analysis

    PubMed Central

    Street, Andrew; Gomes, Manuel; Bojke, Chris

    2015-01-01

    Summary Objective The best practice tariff for hip and knee replacement in the English National Health Service (NHS) rewards providers based on improvements in patient-reported outcome measures (PROMs) collected before and after surgery. Providers only receive a bonus if at least 50% of their patients complete the preoperative questionnaire. We determined how many providers failed to meet this threshold prior to the policy introduction and assessed longitudinal stability of participation rates. Design Retrospective observational study using data from Hospital Episode Statistics and the national PROM programme from April 2009 to March 2012. We calculated participation rates based on either (a) all PROM records or (b) only those that could be linked to inpatient records; constructed confidence intervals around rates to account for sampling variation; applied precision weighting to allow for volume; and applied risk adjustment. Setting NHS hospitals and private providers in England. Participants NHS patients undergoing elective unilateral hip and knee replacement surgery. Main outcome measures Number of providers with participation rates statistically significantly below 50%. Results Crude rates identified many providers that failed to achieve the 50% threshold but there were substantially fewer after adjusting for uncertainty and precision. While important, risk adjustment required restricting the analysis to linked data. Year-on-year correlation between provider participation rates was moderate. Conclusions Participation rates have improved over time and only a small number of providers now fall below the threshold, but administering preoperative questionnaires remains problematic in some providers. We recommend that participation rates are based on linked data and take into account sampling variation. PMID:25827906

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

    PubMed Central

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

    2015-01-01

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

  19. QUALITY OF LIFE AFTER VERTICAL GASTRECTOMY EVALUATED BY THE BAROS QUESTIONNAIRE

    PubMed Central

    VARGAS, Guilherme Pedroso; MENDES, Giselle Abigail; Pinto, Rinaldo Danesi

    2017-01-01

    ABSTRACT Background : The satisfactory outcome in the surgical treatment of obesity must include, in addition to weight loss, a significant change in the pre-existing comorbidities and in the quality of life of the patients. Aim : To evaluate the quality of life in the late postoperative period in patients that underwent videolaparoscopic sleeve gastrectomy. Methods : Was applied the questionnaire “Bariatric Analysis and Reporting Outcome System” (BAROS) in patients that underwent videolaparoscopic sleeve gastrectomy. Results : A total of 47 patients between 21-60 years old were evaluated. The total mean of the BMI before surgery was 43.06±5.87 kg/m². The average percentage of the reduction of excess weight after surgery was 85.46±23.6%. The score obtained by patients in the questionnaire about the improvement in the quality of life showed excellent (36.17%), very good (40.43%), good (21.28%) and reasonable (2.13%) results. There was clinical improvement after surgery in all comorbidities investigated. Conclusion : BAROS showed excellent results in 36.17%, very good in 40.43%, good in 21.28% and reasonable in 2.13%. The weight loss was critical to improve the quality of life and offered the resolution or clinical improvement in all of the investigated comorbidities. PMID:29340547

  20. A clinical observational study on patient-reported outcomes, hip functional performance and return to sports activities in hip arthroscopy patients.

    PubMed

    Tijssen, Marsha; van Cingel, Robert; de Visser, Enrico; Nijhuis-van der Sanden, Maria

    2016-07-01

    To describe data of short- and midterm results of hip arthroscopy patients based on patient-reported hip function, hip functional performance and return to sports activities. Observational cohort study. Sports medical center. 37 recreational athletes (21 men) at least six months after finishing rehabilitation for hip arthroscopy. International Hip Outcome Tool 33 (IHOT-33), Pain Visual Analogue Scale (VAS), Global Perceived Effect Scale (GPE), sports questionnaires and hip functional performance tests. At a mean follow-up time of 2.3 years, 81% of participants reported improvement on the GPE and 84% returned to sports activities. The mean IHOT-33 score was 69.3; the mean VAS score was 35.0. Range of motion (ROM) and strength were within the 90% Limb Symmetry Index (LSI) limit, except for hip internal rotation ROM. A full recovery of hip functional performance, as measured with balance and hop tests, was established based on the 90% LSI limit. The overall short- and midterm results of these follow-up data show good recovery of hip arthroscopy patients on patient-reported outcomes, functional performance and return to sports activities. The functional performance tests used in this study seem adequate for measuring recovery in hip arthroscopy patients. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews.

    PubMed

    Saini, Pooja; Loke, Yoon K; Gamble, Carrol; Altman, Douglas G; Williamson, Paula R; Kirkham, Jamie J

    2014-11-21

    To determine the extent and nature of selective non-reporting of harm outcomes in clinical studies that were eligible for inclusion in a cohort of systematic reviews. Cohort study of systematic reviews from two databases. Outcome reporting bias in trials for harm outcomes (ORBIT II) in systematic reviews from the Cochrane Library and a separate cohort of systematic reviews of adverse events. 92 systematic reviews of randomised controlled trials and non-randomised studies published in the Cochrane Library between issue 9, 2012 and issue 2, 2013 (Cochrane cohort) and 230 systematic reviews published between 1 January 2007 and 31 December 2011 in other publications, synthesising data on harm outcomes (adverse event cohort). A 13 point classification system for missing outcome data on harm was developed and applied to the studies. 86% (79/92) of reviews in the Cochrane cohort did not include full data from the main harm outcome of interest of each review for all of the eligible studies included within that review; 76% (173/230) for the adverse event cohort. Overall, the single primary harm outcome was inadequately reported in 76% (705/931) of the studies included in the 92 reviews from the Cochrane cohort and not reported in 47% (4159/8837) of the 230 reviews in the adverse event cohort. In a sample of primary studies not reporting on the single primary harm outcome in the review, scrutiny of the study publication revealed that outcome reporting bias was suspected in nearly two thirds (63%, 248/393). The number of reviews suspected of outcome reporting bias as a result of missing or partially reported harm related outcomes from at least one eligible study is high. The declaration of important harms and the quality of the reporting of harm outcomes must be improved in both primary studies and systematic reviews. © Saini et al 2014.

  2. 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…

  3. CLINICAL OUTCOMES AND SELF-REPORTED SYMPTOMS IN PATIENTS WITH ACROMEGALY: AN 8-YEAR FOLLOW-UP OF A LANREOTIDE STUDY.

    PubMed

    Khairi, Shafaq; Sagvand, Babak Torabi; Pulaski-Liebert, Karen J; Tritos, Nicholas A; Klibanski, Anne; Nachtigall, Lisa B

    2017-01-01

    The aim of this study was to evaluate the proportion of patients with acromegaly who remained on long-term lanreotide depot after completion of an open-label multicenter phase III clinical trial (SALSA: A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel), compare baseline and long-term follow-up symptoms scores, and correlate scores with individual longitudinal clinical outcomes. Records of all subjects previously enrolled at the Massachusetts General Hospital site of SALSA were reviewed. Those who remained on lanreotide were interviewed and asked to complete a questionnaire that they had filled out in SALSA in 2007 regarding their current symptomatology and injection side effects, as well as to complete the Acromegaly Quality of Life Questionnaire. Furthermore, clinical, biochemical, and radiographic data related to acromegaly and its comorbidities were tracked throughout follow-up. Six out of 7 patients chose to remain on lanreotide, and 5 of them continued lanreotide depot through last follow-up, for up to 8 years or in 1 case until death. In all cases, lanreotide remained well tolerated, and insulin-like growth factor-1 levels and pituitary imaging remained well controlled on stable doses. While comorbidities persisted or developed, the self-reported symptom score after up to 8 years of therapy showed a significant decrease in frequency or resolution in symptoms that were reported at baseline. This study shows a significant decrease in frequency or resolution in self-reported symptoms in well-controlled patients receiving long-term lanreotide therapy. AcroQoL = Acromegaly Quality of Life Questionnaire GH = growth hormone GI = gastrointestinal IGF-1 = insulin-like growth factor-1 SALSA = A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel.

  4. Sexual Outcomes and Satisfaction with Hysterectomy: Influence of Patient Education

    PubMed Central

    Bradford, Andrea; Meston, Cindy

    2010-01-01

    Introduction Many women experience improved sexual function after hysterectomy. However, a sizeable minority of women report worsened sexual function after the surgery, and concerns about the effect of surgery on sexual function are common among women planning to undergo hysterectomy. Aim The present study examined the role of education about the potential sexual consequences of hysterectomy in predicting self-reported outcomes and satisfaction with the procedure. Methods We conducted a cross-sectional survey of 204 women who had undergone simple hysterectomy in the preceding 3–12 months. Participants volunteered in response to a Web-based advertisement. Main Outcome Measures Participants indicated their current sexual function using the Female Sexual Function Index (FSFI), and reported positive and negative sexual outcomes experienced after hysterectomy using a checklist. Participants also completed questionnaire items regarding satisfaction with hysterectomy and education from their physicians about sexual risks and benefits prior to surgery. Results Current sexual function scores were related to self-reports of positive and negative sexual outcomes following hysterectomy and overall satisfaction with hysterectomy. Education from a physician about possible adverse sexual outcomes was largely unrelated to self-reports of having experienced those outcomes. However, education about possible negative sexual outcomes predicted overall satisfaction with hysterectomy when controlling for self-reports of positive and negative sexual outcomes. Conclusion Education about potential negative sexual outcomes after surgery may enhance satisfaction with hysterectomy, independent of whether negative sexual outcomes were experienced. Including a discussion of potential sexual changes after surgery may enhance the benefits of presurgical counseling prior to hysterectomy. PMID:17087803

  5. Proposed standards for reporting outcomes of treating biliary injuries.

    PubMed

    Cho, Jai Young; Baron, Todd H; Carr-Locke, David L; Chapman, William C; Costamagna, Guido; de Santibanes, Eduardo; Dominguez Rosado, Ismael; Garden, O James; Gouma, Dirk; Lillemoe, Keith D; Angel Mercado, Miguel; Mullady, Daniel K; Padbury, Robert; Picus, Daniel; Pitt, Henry A; Sherman, Stuart; Shlansky-Goldberg, Richard; Tornqvist, Bjorn; Strasberg, Steven M

    2018-04-01

    There is no standard nor widely accepted way of reporting outcomes of treatment of biliary injuries. This hinders comparison of results among approaches and among centers. This paper presents a proposal to standardize terminology and reporting of results of treating biliary injuries. The proposal was developed by an international group of surgeons, biliary endoscopists and interventional radiologists. The method is based on the concept of "patency" and is similar to the approach used to create reporting standards for arteriovenous hemodialysis access. The group considered definitions and gradings under the following headings: Definition of Patency, Definition of Index Treatment Periods, Grading of Severity of Biliary Injury, Grading of Patency, Metrics, Comparison of Surgical to Non Surgical Treatments and Presentation of Case Series. A standard procedure for reporting outcomes of treating biliary injuries has been produced. It is applicable to presenting results of treatment by surgery, endoscopy, and interventional radiology. Copyright © 2017 International Hepato-Pancreato-Biliary Association Inc. Published by Elsevier Ltd. All rights reserved.

  6. Patient-reported outcome instruments that evaluate adherence behaviours in adults with asthma: A systematic review of measurement properties.

    PubMed

    Gagné, Myriam; Boulet, Louis-Philippe; Pérez, Norma; Moisan, Jocelyne

    2018-04-30

    To systematically identify the measurement properties of patient-reported outcome instruments (PROs) that evaluate adherence to inhaled maintenance medication in adults with asthma. We conducted a systematic review of six databases. Two reviewers independently included studies on the measurement properties of PROs that evaluated adherence in asthmatic participants aged ≥18 years. Based on the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), the reviewers (1) extracted data on internal consistency, reliability, measurement error, content validity, structural validity, hypotheses testing, cross-cultural validity, criterion validity, and responsiveness; (2) assessed the methodological quality of the included studies; (3) assessed the quality of the measurement properties (positive or negative); and (4) summarised the level of evidence (limited, moderate, or strong). We screened 6,068 records and included 15 studies (14 PROs). No studies evaluated measurement error or responsiveness. Based on methodological and measurement property quality assessments, we found limited positive evidence of: (a) internal consistency of the Adherence Questionnaire, Refined Medication Adherence Reason Scale (MAR-Scale), Medication Adherence Report Scale for Asthma (MARS-A), and Test of the Adherence to Inhalers (TAI); (b) reliability of the TAI; and (c) structural validity of the Adherence Questionnaire, MAR-Scale, MARS-A, and TAI. We also found limited negative evidence of: (d) hypotheses testing of Adherence Questionnaire; (e) reliability of the MARS-A; and (f) criterion validity of the MARS-A and TAI. Our results highlighted the need to conduct further high-quality studies that will positively evaluate the reliability, validity, and responsiveness of the available PROs. This article is protected by copyright. All rights reserved.

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

    PubMed

    Self, M M; Williams, A E; Czyzewski, D I; Weidler, E M; Shulman, R J

    2015-08-01

    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 capturing patient and parent report of irritable bowel syndrome (IBS) symptoms is important. This study evaluated correspondence between retrospective questionnaire (parent and child report) and prospective diary data for children and adolescents with IBS. Participants included 50 children/adolescents with IBS per Rome III criteria. Children completed a 2-week pain and stool diary. Children and parents subsequently completed a 2-week recall questionnaire, reporting number of pain days, maximum pain, days without bowel movement, and days with diarrhea during the diary interval. Intraclass correlation coefficients and Bland-Altman plots assessed agreement. For pain and days without bowel movement, overall agreement between child recall questionnaire and child diary was strong, although under conditions likely to facilitate agreement and with individual variation observed. Parent recall and child diary were less concordant, and agreement about diarrhea was poor for parent and child. Age did not significantly correlate with agreement. Child questionnaire with short recall interval may be a reasonable approximation for diary data, although this varies by individual and replication/investigation of lengthier recall are needed. Relying on parent questionnaire does not appear a suitable proxy, and recall of stool form by both parent and child appears more problematic. These results combined with existing literature support use of diary data whenever possible. © 2015 John Wiley & Sons Ltd.

  8. Behavioural, educational and respiratory outcomes of antenatal betamethasone for term caesarean section (ASTECS trial)

    PubMed Central

    Stutchfield, Peter Roy; Whitaker, Rhiannon; Gliddon, Angela E; Hobson, Lucie; Kotecha, Sailesh; Doull, Iolo J M

    2013-01-01

    Objectives To determine whether antenatal betamethasone prior to elective term caesarean section (CS) affects long term behavioural, cognitive or developmental outcome, and whether the risk of asthma or atopic disease is reduced. Design A questionnaire based follow-up of a multicentre randomised controlled trial (Antenatal Steroids for Term Elective Caesarean Section, BMJ 2005). Setting Four UK study centres from the original trial. Participants 862 participants from the four largest recruiting centres, 92% of the original study. 824 (96%) were traced and 799 (93%) were successfully contacted. Fifty-one percent (407/799) completed and returned the questionnaire. The children were aged 8–15 years (median 12.2 years, 52% girls). 386 gave consent to contact schools with 352 (91%) reports received. Main outcome measures Questionnaires including a strengths and difficulties questionnaire, International Study of Asthma and Allergies in Childhood, general health and school performance. Results There were no significant differences between children whose mothers received betamethasone and controls for the mean total strengths and difficulties questionnaire scores and subscores for hyperactivity, emotional symptoms, prosocial behaviour, conduct or peer problems. 25 (12%) children whose mothers received betamethasone had reported learning difficulties compared with 27 (14%) control children. The proportion of children who achieved standard assessment tests KS2 exams level 4 or above for mathematics, English or science was similar as were the rates of ever reported wheeze (30% vs 30%), asthma (24% vs 21%), eczema (34% vs 37%) and hay fever (25% vs 27%). Conclusions Antenatal betamethasone did not result in any adverse outcomes or reduction in asthma or atopy. It should be considered for elective CS at 37–38 weeks of gestation. Trial registration: Original trial was preregistration, the trial publication is BMJ. 2005 Sep 24;331(7518):662. PMID:23424017

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

    PubMed Central

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

    2017-01-01

    Evidence-informed decision-making in clinical care and policy in nephrology is undermined by trials that selectively report a large number of heterogeneous outcomes, many of which are not patient-centered. The Standardized Outcomes in Nephrology−Hemodialysis (SONG-HD) Initiative convened an international consensus workshop on November 7, 2015, to discuss the identification and implementation of a potential core outcome set for all trials in hemodialysis. The purpose of this article is to report qualitative analyses of the workshop discussions, describing the key aspects to consider when establishing core outcomes in trials involving patients on hemodialysis. Key stakeholders including eight patients/caregivers and 47 health professionals (nephrologists, policy makers, industry, researchers) attended the workshop. Attendees suggested that identifying core outcomes required equitable stakeholder engagement to ensure relevance across patient populations; flexibility to consider evolving priorities over time; deconstruction of language and meaning for conceptual consistency and clarity; understanding of potential overlap and associations between outcomes; and an assessment of applicability to the range of interventions in hemodialysis. For implementation, they proposed that core outcomes must have simple, inexpensive and validated outcome measures that could be used in clinical care (quality ndicators) and trials (including pragmatic trials), and endorsement by regulatory agencies. Integrating these recommendations may foster acceptance and optimize the uptake and translation of core outcomes in hemodialysis, leading to more informative research, for better treatment, and improved patient outcomes. PMID:27497527

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

    PubMed

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

    2017-01-01

    Evidence-informed decision making in clinical care and policy in nephrology is undermined by trials that selectively report a large number of heterogeneous outcomes, many of which are not patient centered. The Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Initiative convened an international consensus workshop on November 7, 2015, to discuss the identification and implementation of a potential core outcome set for all trials in hemodialysis. The purpose of this article is to report qualitative analyses of the workshop discussions, describing the key aspects to consider when establishing core outcomes in trials involving patients on hemodialysis therapy. Key stakeholders including 8 patients/caregivers and 47 health professionals (nephrologists, policymakers, industry, and researchers) attended the workshop. Attendees suggested that identifying core outcomes required equitable stakeholder engagement to ensure relevance across patient populations, flexibility to consider evolving priorities over time, deconstruction of language and meaning for conceptual consistency and clarity, understanding of potential overlap and associations between outcomes, and an assessment of applicability to the range of interventions in hemodialysis. For implementation, they proposed that core outcomes must have simple, inexpensive, and validated outcome measures that could be used in clinical care (quality indicators) and trials (including pragmatic trials) and endorsement by regulatory agencies. Integrating these recommendations may foster acceptance and optimize the uptake and translation of core outcomes in hemodialysis, leading to more informative research, for better treatment and improved patient outcomes. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

  11. Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data.

    PubMed

    Wieseler, Beate; Wolfram, Natalia; McGauran, Natalie; Kerekes, Michaela F; Vervölgyi, Volker; Kohlepp, Petra; Kamphuis, Marloes; Grouven, Ulrich

    2013-10-01

    Access to unpublished clinical study reports (CSRs) is currently being discussed as a means to allow unbiased evaluation of clinical research. The Institute for Quality and Efficiency in Health Care (IQWiG) routinely requests CSRs from manufacturers for its drug assessments. Our objective was to determine the information gain from CSRs compared to publicly available sources (journal publications and registry reports) for patient-relevant outcomes included in IQWiG health technology assessments (HTAs) of drugs. We used a sample of 101 trials with full CSRs received for 16 HTAs of drugs completed by IQWiG between 15 January 2006 and 14 February 2011, and analyzed the CSRs and the publicly available sources of these trials. For each document type we assessed the completeness of information on all patient-relevant outcomes included in the HTAs (benefit outcomes, e.g., mortality, symptoms, and health-related quality of life; harm outcomes, e.g., adverse events). We dichotomized the outcomes as "completely reported" or "incompletely reported." For each document type, we calculated the proportion of outcomes with complete information per outcome category and overall. We analyzed 101 trials with CSRs; 86 had at least one publicly available source, 65 at least one journal publication, and 50 a registry report. The trials included 1,080 patient-relevant outcomes. The CSRs provided complete information on a considerably higher proportion of outcomes (86%) than the combined publicly available sources (39%). With the exception of health-related quality of life (57%), CSRs provided complete information on 78% to 100% of the various benefit outcomes (combined publicly available sources: 20% to 53%). CSRs also provided considerably more information on harms. The differences in completeness of information for patient-relevant outcomes between CSRs and journal publications or registry reports (or a combination of both) were statistically significant for all types of outcomes. The

  12. VALIDITATION OF A LIGHT QUESTIONNAIRE WITH REAL-LIFE PHOTOPIC ILLUMINANCE MEASUREMENTS: THE HARVARD LIGHT EXPOSURE ASSESSMENT QUESTIONNAIRE

    PubMed Central

    Bajaj, Archna; Rosner, Bernard; Lockley, Steven; Schernhammer, Eva S.

    2011-01-01

    Background Light exposure at night is now considered a probable carcinogen. To study the effects of light on chronic diseases like cancer, methods to measure light exposure in large observational studies are needed. We aimed to investigate the validity of self-reported current light exposure. Methods We developed a self-administered semiquantitative light questionnaire, the Harvard Light Exposure Assessment (H-LEA) questionnaire, and compared photopic scores derived from this questionnaire with actual photopic and circadian measures obtained from a real-life 7-day light meter application among 132 women (85 rotating night shift workers and 47 day workers) participating in the Nurses' Health Study II. Results After adjustment for age, BMI, collection day, and night work status, the overall partial Spearman correlation between self-report of light exposure and actual photopic light measurements was 0.72 (P<0.001; Kendall τ =0.57) and 0.73 (P<0.0001; Kendall τ =0.58) when correlating circadian light measurements. There were only minimal differences in accuracy of self-report of light exposure and photopic or circadian light measurement between day (r=0.77 and 0.78, respectively) and rotating night shift workers (r=0.68 and 0.69, respectively). Conclusions The results of this study provide evidence of the criterion validity of self-reported light exposure using the H-LEA questionnaire. Impact: This questionnaire is a practical method of assessing light exposure in large scale epidemiologic studies. PMID:21737411

  13. How to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline.

    PubMed

    Prinsen, Cecilia A C; Vohra, Sunita; Rose, Michael R; Boers, Maarten; Tugwell, Peter; Clarke, Mike; Williamson, Paula R; Terwee, Caroline B

    2016-09-13

    In cooperation with the Core Outcome Measures in Effectiveness Trials (COMET) initiative, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative aimed to develop a guideline on how to select outcome measurement instruments for outcomes (i.e., constructs or domains) included in a "Core Outcome Set" (COS). 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. Informed by a literature review to identify potentially relevant tasks on outcome measurement instrument selection, a Delphi study was performed among a panel of international experts, representing diverse stakeholders. In three consecutive rounds, panelists were asked to rate the importance of different tasks in the selection of outcome measurement instruments, to justify their choices, and to add other relevant tasks. Consensus was defined as being achieved when 70 % or more of the panelists agreed and when fewer than 15 % of the panelists disagreed. Of the 481 invited experts, 120 agreed to participate of whom 95 (79 %) completed the first Delphi questionnaire. We reached consensus on four main steps in the selection of outcome measurement instruments for COS: Step 1, conceptual considerations; Step 2, finding existing outcome measurement instruments, by means of a systematic review and/or a literature search; Step 3, quality assessment of outcome measurement instruments, by means of the evaluation of the measurement properties and feasibility aspects of outcome measurement instruments; and Step 4, generic recommendations on the selection of outcome measurement instruments for outcomes included in a COS (consensus ranged from 70 to 99 %). This study resulted in a consensus-based guideline on the methods for selecting outcome measurement instruments for outcomes included in a COS. This guideline can be used by COS developers in defining how to measure core outcomes.

  14. Reported outcomes of 453 pregnancies in patients with Gaucher disease: An analysis from the Gaucher outcome survey.

    PubMed

    Lau, Heather; Belmatoug, Nadia; Deegan, Patrick; Goker-Alpan, Ozlem; Schwartz, Ida Vanessa D; Shankar, Suma P; Panahloo, Zoya; Zimran, Ari

    2018-02-01

    Gaucher disease (GD) may worsen during pregnancy, leading to the discussion of continuing treatment during pregnancy. We examined fetal outcomes of pregnancies reported in the Gaucher Outcome Survey, an international GD-specific registry established in 2010. A total of 453 pregnancies were reported. Most pregnancies (336/453, 74.2%) were in women who did not receive GD-specific treatment during pregnancy, while enzyme replacement therapy (ERT) was received during 117/453 (25.8%) pregnancies. No pregnancies exposed to substrate reduction therapy were reported. The percentage of normal outcomes (live birth delivered at term with no congenital abnormalities) was similar in untreated and treated pregnancies (92.9% vs. 91.4%). The percentage of spontaneous abortions in untreated pregnancies was 3.6% (95% CI, 1.9%- 6.2%) compared with 6.9% (95% CI, 3.0%-13.1%) in treated pregnancies (p=0.1866). In women who received velaglucerase alfa <1month prior to conception and/or during pregnancy, 34/36 (94.4%) pregnancies had normal outcomes and 2 (5.6%) ended in spontaneous abortion. Normal outcomes were observed in the 20 pregnancies with velaglucerase alfa exposure starting <1month prior to conception and continuing through all trimesters. These observations, in addition to information in the literature, suggest that continuation of ERT during pregnancy may be appropriate for GD patients. Copyright © 2016 Shire Human Genetic Therapies, Inc. Published by Elsevier Inc. All rights reserved.

  15. Health status measurement in COPD: the minimal clinically important difference of the clinical COPD questionnaire

    PubMed Central

    Kocks, JWH; Tuinenga, MG; Uil, SM; van den Berg, JWK; Ståhl, E; van der Molen, T

    2006-01-01

    Background Patient-reported outcomes (PRO) questionnaires are being increasingly used in COPD clinical studies. The challenge facing investigators is to determine what change is significant, ie what is the minimal clinically important difference (MCID). This study aimed to identify the MCID for the clinical COPD questionnaire (CCQ) in terms of patient referencing, criterion referencing, and by the standard error of measurement (SEM). Methods Patients were ≥40 years of age, diagnosed with COPD, had a smoking history of >10 pack-years, and were participating in a randomized, controlled clinical trial comparing intravenous and oral prednisolone in patients admitted with an acute exacerbation of COPD. The CCQ was completed on Days 1–7 and 42. A Global Rating of Change (GRC) assessment was taken to establish the MCID by patient referencing. For criterion referencing, health events during a period of 1 year after Day 42 were included in this analysis. Results 210 patients were recruited, 168 completed the CCQ questionnaire on Day42. The MCID of the CCQ total score, as indicated by patient referencing in terms of the GRC, was 0.44. The MCID of the CCQ in terms of criterion referencing for the major outcomes was 0.39, and calculation of the SEM resulted in a value of 0.21. Conclusion This investigation, which is the first to determine the MCID of a PRO questionnaire via more than one approach, indicates that the MCID of the CCQ total score is 0.4. PMID:16603063

  16. 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

  17. Study protocol: patient reported outcomes for bladder management strategies in spinal cord injury.

    PubMed

    Patel, Darshan P; Lenherr, Sara M; Stoffel, John T; Elliott, Sean P; Welk, Blayne; Presson, Angela P; Jha, Amitabh; Rosenbluth, Jeffrey; Myers, Jeremy B

    2017-10-10

    The majority of spinal cord injury (SCI) patients have urinary issues, such as incontinence, retention, and frequency. These problems place a significant burden on patients' physical health and quality of life (QoL). There are a wide variety of bladder management strategies available to patients with no clear guidelines on appropriate selection. Inappropriate bladder management can cause hospitalizations and serious complications, such as urosepsis and renal failure. Patients believe that both independence and ability to carry out daily activities are just as important as physical health in selecting the right bladder-management strategy but little is known about patient's QoL with different bladder managements. Our study's aim is to assess patient reported QoL measures with various bladder managements after SCI. This manuscript describes the approach, study design and common data elements for our central study. This is a multi-institutional prospective cohort study comparing three different bladder-management strategies (clean intermittent catheterization, indwelling catheters, and surgery). Information collected from participants includes demographics, past medical and surgical history, injury characteristics, current and past bladder management, and SCI /bladder-related complications. Patient reported outcomes and QoL questionnaires were administered at enrollment and every 3 months for 1 year. Aims of this study protocol are: (1) to assess baseline QoL differences between the three different bladder-management strategies; (2) determine QoL impact when those using either form of catheter management undergo a surgery over the 1 year of follow-up among patients eligible for surgery; (3) assess the effects of changes in bladder management and complications on QoL over a 1-year longitudinal follow-up. By providing information about patient-reported outcomes associated with different bladder management strategies after SCI, and the impact of bladder management

  18. Long-Term Quality of Life Outcome After Proton Beam Monotherapy for Localized Prostate Cancer

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Coen, John J., E-mail: jcoen@partners.org; Paly, Jonathan J.; Niemierko, Andrzej

    Objectives: High-dose external radiation for localized prostate cancer results in favorable clinical outcomes and low toxicity rates. Here, we report long-term quality of life (QOL) outcome for men treated with conformal protons. Methods: QOL questionnaires were sent at specified intervals to 95 men who received proton radiation. Of these, 87 men reported 3- and/or 12-month outcomes, whereas 73 also reported long-term outcomes (minimum 2 years). Symptom scores were calculated at baseline, 3 months, 12 months, and long-term follow-up. Generalized estimating equation models were constructed to assess longitudinal outcomes while accounting for correlation among repeated measures in an individual patient. Menmore » were stratified into functional groups from their baseline questionnaires (normal, intermediate, or poor function) for each symptom domain. Long-term QOL changes were assessed overall and within functional groups using the Wilcoxon signed-rank test. Results: Statistically significant changes in all four symptom scores were observed in the longitudinal analysis. For the 73 men reporting long-term outcomes, there were significant change scores for incontinence (ID), bowel (BD) and sexual dysfunction (SD), but not obstructive/irritative voiding dysfunction (OID). When stratified by baseline functional category, only men with normal function had increased scores for ID and BD. For SD, there were significant changes in men with both normal and intermediate function, but not poor function. Conclusions: Patient reported outcomes are sensitive indicators of treatment-related morbidity. These results quantitate the long-term consequences of proton monotherapy for prostate cancer. Analysis by baseline functional category provides an individualized prediction of long-term QOL scores. High dose proton radiation was associated with small increases in bowel dysfunction and incontinence, with more pronounced changes in sexual dysfunction.« less

  19. The pediatric daytime sleepiness scale (PDSS): sleep habits and school outcomes in middle-school children.

    PubMed

    Drake, Christopher; Nickel, Chelsea; Burduvali, Eleni; Roth, Thomas; Jefferson, Catherine; Pietro, Badia

    2003-06-15

    To develop a measure of daytime sleepiness suitable for middle-school children and examine the relationship between daytime sleepiness and school-related outcomes. Self-report questionnaire. Four hundred fifty, 11- to 15-year-old students, from grades 6, 7, and 8 of a public middle school in Dayton, Ohio. A pediatric daytime sleepiness questionnaire was developed using factor analysis of questions regarding sleep-related behaviors. Results of the sleepiness questionnaire were then compared across other variables, including daily sleep patterns, school achievement, mood, and extracurricular activities. Factor analysis on the 13 questions related to daytime sleepiness yielded 1 primary factor ("pediatric daytime sleepiness"; 32% of variance). Only items with factor loadings above .4 were included in the final sleepiness scale. Internal consistency (Chronbach's alpha) for the final 8-item scale was .80. Separate one-way analyses of variance and trend analyses were performed comparing pediatric daytime sleepiness scores at the 5 different levels of total sleep time and academic achievement. Participants who reported low school achievement, high rates of absenteeism, low school enjoyment, low total sleep time, and frequent illness reported significantly higher levels of daytime sleepiness compared to children with better school-related outcomes. The self-report scale developed in the present work is suitable for middle-school-age children and may be useful in future research given its ease of administration and robust psychometric properties. Daytime sleepiness is related to reduced educational achievement and other negative school-related outcomes.

  20. Ability of three motor measures to predict functional outcomes reported by stroke patients after rehabilitation.

    PubMed

    Li, Kuan-Yi; Lin, Keh-Chung; Wang, Tien-Ni; Wu, Ching-Yi; Huang, Yan-Hua; Ouyang, Pei

    2012-01-01

    This investigation examined the demographic characteristics along with 3 measures of motor function in determining outcomes in activities of daily living (ADL) after distributed constraint-induced therapy (dCIT). The study recruited 69 stroke patients who received 3 weeks of dCIT for 2 hours daily, 5 days a week. The self-reported outcome measures for daily function were the Motor Activity Log (MAL) including the amount of use (AOU) and quality of movement (QOM), Nottingham Extended Activities of Daily Living Questionnaire (NEADL), and the Stroke Impact Scale (SIS). Age, sex, onset, side of stroke, Fugl-Meyer assessment (FMA), Wolf Motor Function Test (WMFT), and Action Research Arm Test (ARAT) were the potential predictors. The ARAT grasp-grip-pinch score was the most dominant predictor for MAL-AOU and NEADL (P< 0.05), and the ARAT total score for the subscore of the ADL/instrumental ADL section of the SIS (P< 0.05). The FMA wrist-hand score was a significant predictor for MAL-QOM (P< 0.05). Age was the only demographic factor that significantly predicted NEADL performance (P< 0.05). Among the 3 commonly used measures of motor function after stroke, ARAT was the strongest determinant in predicting MAL-AOU, MAL-QOM, and SIS-ADL/instrumental ADL after dCIT.

  1. Aggregated adverse-events outcomes in oncology phase III reports: A systematic review.

    PubMed

    Maillet, Denis; Gan, Hui K; Blay, Jean-Yves; You, Benoit; Péron, Julien

    2016-01-01

    Randomised controlled trials (RCTs) represent a major source of information on treatment-related adverse events (AEs). In this study, we reviewed the use and the reporting methods of aggregated-AEs (A-AEs) outcomes in RCTs reports published in oncology and compared that to the expectations of European Organisation for Research and Treatment of Cancer (EORTC) membership. RCTs reports published between 2007 and 2011 were reviewed regarding the reporting of A-AEs-outcomes. A-AEs were defined as summary outcome combining several related AEs, usually grouped by organ system e.g. cardiac-AEs, dermatologic-AEs. Trial characteristics associated with the use of A-AEs outcomes were investigated. The expectation of EORTC members concerning A-AEs utilisation was queried through a survey. Among 325 RCTs published between 2007 and 2011, 94 (29%) included one or more A-AE outcomes. A clear description of the nature of AEs included in such aggregations was provided in 19 articles (20%). No description of A-AEs was conversely provided in the other 75 articles (80%). The most commonly used A-AEs-outcomes were dermatologic-AEs (45%) and cardiac-AEs (33%). In multivariate analysis, the use of A-AEs outcomes was more frequent when trials were conducted in Europe (p = 0.038) and in trials performed on colon/rectal cancers (p = 0.016). Finally, there is no consensus of EORTC members regarding the utilisation of A-AEs but a majority of them (88%) felt that a clear description of A-AEs should systematically be reported. The use of A-AEs is infrequent in oncology RCT manuscripts although their use is accepted by most clinicians. However, a clear definition of A-AEs is strongly recommended if they are to be used in order to avoid a loss of important details about drug toxicities that is useful to clinicians. Copyright © 2015 Elsevier Ltd. All rights reserved.

  2. Measurement Properties of the Scoliosis Research Society Outcomes Questionnaire in Adolescent Patients With Spondylolisthesis.

    PubMed

    Gutman, Gabriel; Joncas, Julie; Mac-Thiong, Jean-Marc; Beauséjour, Marie; Roy-Beaudry, Marjolaine; Labelle, Hubert; Parent, Stefan

    2017-09-01

    Prospective validation of the Scoliosis Research Society Outcomes Questionnaire French-Canadian version (SRS-22fv) in adolescent patients with spondylolisthesis. To determine the measurement properties of the SRS-22fv. The SRS-22 is widely used for the assessment of health-related quality of life in adolescent idiopathic scoliosis (AIS) and other spinal deformities. Spondylolisthesis has an important effect on quality of life. The instrument was previously used in this population, although its measurement properties remained unknown. We aim to determine its reliability, factorial, concurrent validity, and its discriminant capacity in an adolescent spondylolisthesis population. The SRS-22fv was tested in 479 subjects (272 patients with spondylolisthesis, 143 with AIS, and 64 controls) at a single institution. Its reliability was measured using the coefficient of internal consistency, concurrent validity by the short form-12 (SF-12v2 French version) and discriminant validity using multivariate analysis of variance, analysis of covariance, and multivariate linear regression. The SRS-22fv showed a good global internal consistency (spondylolisthesis: Cronbach α = 0.91, AIS: 0.86, and controls: 0.78) in all its domains for spondylolisthesis patients. It showed a factorial structure consistent with the original questionnaire, with 60% of explained variance under four factors. Moderate to high correlation coefficients were found for specifically corresponding domains between SRS-22fv and SF-12v2. Boys had higher scores than do girls, scores worsened with increasing age and body mass index. Analysis of covariance showed statistically significant differences between patients with spondylolisthesis, patients with AIS, and controls when controlling for age, sex, body mass index, pain, function, and self-image scores. In the spondylolisthesis group, scores on all domains and mean total scores were significantly lower in surgical candidates and in patients with high

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

    PubMed

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

    2017-03-20

    We aimed to study whether patient-reported outcomes, measured by quality of life (QoL) and functional class, are sensitive to pleural effusion (PLE) in patients with heart failure (HF), and to study changes in QoL and functional class during follow-up of PLE. A cohort of 62 patients from an outpatient HF clinic was included. The amount of PLE was quantified using a pocket-sized ultrasound imaging device. Self-reports of QoL and functional class were collected using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the New York Heart Association (NYHA) functional classification. At baseline, 26 (42%) patients had PLE of which 19 (31%) patients had moderate to severe amounts of PLE. Patients with no to mild PLE had a lower MLHFQ score (mean 42, SD 21) compared with patients with a moderate to severe amount of PLE (mean 55, SD 24), p=0.03. For 28 patients (45%) with follow-up data, we observed a linear improvement of the MLHFQ-score (3.2, 95% CI 1.2 to 5.1) with each centimetre reduction of PLE. Correspondingly, patient-reported NYHA-class followed the same pattern as the MLHFQ-score. Our study indicates that patient-reported outcome measures as MLHFQ may be sensitive tools to identify patients with HF at highest risk of symptomatic PLE and that treatment targeting reduction of PLE during follow-up is essential to improvement of QoL and functional capacity of outpatients with HF. NCT01794715; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  4. Using self-report surveys at the beginning of service to develop multi-outcome risk models for new soldiers in the U.S. Army.

    PubMed

    Rosellini, A J; Stein, M B; Benedek, D M; Bliese, P D; Chiu, W T; Hwang, I; Monahan, J; Nock, M K; Petukhova, M V; Sampson, N A; Street, A E; Zaslavsky, A M; Ursano, R J; Kessler, R C

    2017-10-01

    The U.S. Army uses universal preventives interventions for several negative outcomes (e.g. suicide, violence, sexual assault) with especially high risks in the early years of service. More intensive interventions exist, but would be cost-effective only if targeted at high-risk soldiers. We report results of efforts to develop models for such targeting from self-report surveys administered at the beginning of Army service. 21 832 new soldiers completed a self-administered questionnaire (SAQ) in 2011-2012 and consented to link administrative data to SAQ responses. Penalized regression models were developed for 12 administratively-recorded outcomes occurring by December 2013: suicide attempt, mental hospitalization, positive drug test, traumatic brain injury (TBI), other severe injury, several types of violence perpetration and victimization, demotion, and attrition. The best-performing models were for TBI (AUC = 0.80), major physical violence perpetration (AUC = 0.78), sexual assault perpetration (AUC = 0.78), and suicide attempt (AUC = 0.74). Although predicted risk scores were significantly correlated across outcomes, prediction was not improved by including risk scores for other outcomes in models. Of particular note: 40.5% of suicide attempts occurred among the 10% of new soldiers with highest predicted risk, 57.2% of male sexual assault perpetrations among the 15% with highest predicted risk, and 35.5% of female sexual assault victimizations among the 10% with highest predicted risk. Data collected at the beginning of service in self-report surveys could be used to develop risk models that define small proportions of new soldiers accounting for high proportions of negative outcomes over the first few years of service.

  5. Most efficient questionnaires to measure quality of life, physical function, and pain in patients with metastatic spine disease: a cross-sectional prospective survey study.

    PubMed

    Paulino Pereira, Nuno Rui; Janssen, Stein J; Raskin, Kevin A; Hornicek, Francis J; Ferrone, Marco L; Shin, John H; Bramer, Jos A M; van Dijk, Cornelis Nicolaas; Schwab, Joseph H

    2017-07-01

    Assessing quality of life, functional outcome, and pain has become important in assessing the effectiveness of treatment for metastatic spine disease. Many questionnaires are able to measure these outcomes; few are validated in patients with metastatic spine disease. As a result, there is no consensus on the ideal questionnaire to use in these patients. Our study aim was to assess whether certain questionnaires measuring quality of life, functional outcome, and pain (1) correlated with each other, (2) measured the construct they claim to measure, (3) had good coverage-floor and ceiling effects, (4) were reliable, and (5) whether there were differences in completion time between them. This is a prospective cross-sectional survey study from three outpatient clinics (two orthopedic oncology clinics and one neurosurgery clinic) from two affiliated tertiary hospital care centers. We included 100 consecutive patients with metastatic spine disease between July 2014 and February 2016. We excluded non-English-speaking patients. The following questionnaires were given in random order: Oswestry Disability Index (ODI) or Neck Disability Index (NDI), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function, PROMIS Pain Intensity, EuroQol-5 Dimensions (EQ-5D), and the Spine Oncology Study Group Outcome Questionnaire (SOSG-OQ). We used exploratory factor analysis-correlating questionnaires with an underlying mathematically derived trait-to assess if questionnaires measured the same concept. Coverage was assessed by floor and ceiling effects, and reliability was assessed by standard error of measurement as a function of ability. Differences in completion times were tested using the Friedman test. Questionnaires measured the construct they were developed for, as demonstrated with high correlations (>0.7) with the underlying trait. A floor effect was present in the PROMIS Pain Intensity (7.0%), ODI or NDI (4.0%), and the PROMIS Physical Function (1

  6. [Relative effect per patient (REPP)--outcome groups for total hip replacement and total knee replacement].

    PubMed

    Huber, J; Dabis, E; Zumstein, M D; Hüsler, J

    2013-06-01

    The outcome of orthopaedic surgery such as total hip replacement (THR) or total knee replacement (TKR) is commonly given by the change in mean scores on patient-reported outcome measures (Prom's). This may give the impression that all enrolled patients have experienced an improvement. But the Swedish hip registry and other studies report a reduction of complaints in 80-85 % of patients ("responders"), with the remainder (approximately one in six) remaining unchanged or reporting worse complaints ("non-responders"). According to Cohen, the degree of success in the "responders" group can be subdivided into excellent, good and moderate. For a given treatment, a total of 5 different outcome groups can therefore be defined: excellent, good, moderate, unchanged and worse. Allocation to the groups is based on the "relative effect per patient" (REPP). The REPP is calculated as the base-line score minus the post-treatment score divided by the baseline score. The maximum possible REPP is 1; a REPP of 0 means no effect and a negative REPP means deterioration. Allocation to the outcome groups is as follows: excellent 0.95 to 1 REPP, good 0.5 to 0.95 REPP, moderate over 0.2 to 0.5 REPP, unchanged -0.2 to 0.2 REPP and worse below -0.2 REPP. Our local arthroplasty register was used to evaluate the 1-year outcomes of THR and TKR patients operated between March 2003 and November 2008, using WOMAC scores and EuroQoL scores. Only patients with complete data sets and unilateral THR/TKR were included. The success rate given by the REPP method was compared with that of the "responder rate" method defined by the OMERACT-OARSI criteria. With the WOMAC questionnaire, outcomes were as follows (THR/TKR): excellent 29/14 %, good 51/54 %, moderate 11/13 %, unchanged at 5/12 %, worse 4/7 %. The corresponding values for the EuroQoL were (THR/TKR): excellent 16/6 %, good 41/42 %, moderate 25/28 %, unchanged 12/16 %, worse 6/8 %. For THR, success rates were 92 % using the "responder rate" method

  7. Integrating Electronic Patient-Reported Outcome Measures into Routine HIV Care and the ANRS CO3 Aquitaine Cohort's Data Capture and Visualization System (QuAliV): Protocol for a Formative Research Study.

    PubMed

    Barger, Diana; Leleux, Olivier; Conte, Valérie; Sapparrart, Vincent; Gapillout, Marie; Crespel, Isabelle; Erramouspe, Marie; Delveaux, Sandrine; Dabis, Francois; Bonnet, Fabrice

    2018-06-07

    Effective antiretroviral therapy has greatly reduced HIV-related morbidity and mortality, dramatically changing the demographics of the population of people living with HIV. The majority of people living with HIV in France are well cared for insofar as their HIV infection is concerned but remain at risk for age-associated comorbidities. Their long-term, potentially complex, and growing care needs make the routine, longitudinal assessment of health-related quality of life and other patient-reported outcomes of relevance in the current treatment era. We aim to describe the development of a Web-based electronic patient-reported outcomes system for people living with HIV linked to the ANRS CO3 Aquitaine cohort's data capture and visualization system (ARPEGE) and designed to facilitate the electronic collection of patient-reported data and ultimately promote better patient-physician communication and quality of care (both patient satisfaction and health outcomes). Participants who meet the eligibility criteria will be invited to engage with the Web-based electronic patient-reported outcomes system and provided with the information necessary to create a personal patient account. They will then be able to access the electronic patient-reported outcomes system and complete a set of standardized validated questionnaires covering health-related quality of life (World Health Organization's Quality of Life Instrument in HIV infection, named WHOQOL-HIV BREF) and other patient-reported outcomes. The information provided via questionnaires will ultimately be presented in a summary format for clinicians, together with the patient's HIV care history. The prototype of the Web-based electronic patient-reported outcome system will be finalized and the first 2 formative research phases of the study (prototyping and usability testing) will be conducted from December 2017 to May 2018. We describe the sequential processes planned to ensure that the proposed electronic patient-reported

  8. Relationship between children's performance-based motor skills and child, parent, and teacher perceptions of children's motor abilities using self/informant-report questionnaires.

    PubMed

    Lalor, Aislinn; Brown, Ted; Murdolo, Yuki

    2016-04-01

    Occupational therapists often assess the motor skill performance of children referred to them as part of the assessment process. This study investigated whether children's, parents' and teachers' perceptions of children's motor skills using valid and reliable self/informant-report questionnaires were associated with and predictive of children's actual motor performance, as measured by a standardised performance-based motor skill assessment. Fifty-five typically developing children (8-12 years of age), their parents and classroom teachers were recruited to participate in the study. The children completed the Physical Self-Description Questionnaire (PSDQ) and the Self-Perception Profile for Children. The parents completed the Developmental Profile III (DP-III) and the Developmental Coordination Disorder Questionnaire, whereas the teachers completed the Developmental Coordination Disorder Questionnaire and the Teacher's Rating Scale of Child's Actual Behavior. Children's motor performance composite scores were determined using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2). Spearman's rho correlation coefficients were calculated to identify if significant correlations existed and multiple linear regression was used to identify whether self/informant report data were significant predictors of children's motor skill performance. The child self-report scores had the largest number of significant correlations with the BOT-2 composites. Regression analysis found that the parent report DP-III Physical subscale was a significant predictor of the BOT-2 Manual Coordination composite and the child-report questionnaire PSDQ. Endurance subscale was a significant predictor of the BOT-2 Strength and Agility composite. The findings support the use of top-down assessment methods from a variety of sources when evaluating children's motor abilities. © 2016 Occupational Therapy Australia.

  9. COS-STAR: a reporting guideline for studies developing core outcome sets (protocol).

    PubMed

    Kirkham, Jamie J; Gorst, Sarah; Altman, Douglas G; Blazeby, Jane; Clarke, Mike; Devane, Declan; Gargon, Elizabeth; Williamson, Paula R

    2015-08-22

    Core outcome sets can increase the efficiency and value of research and, as a result, there are an increasing number of studies looking to develop core outcome sets (COS). However, the credibility of a COS depends on both the use of sound methodology in its development and clear and transparent reporting of the processes adopted. To date there is no reporting guideline for reporting COS studies. The aim of this programme of research is to develop a reporting guideline for studies developing COS and to highlight some of the important methodological considerations in the process. The study will include a reporting guideline item generation stage which will then be used in a Delphi study. The Delphi study is anticipated to include two rounds. The first round will ask stakeholders to score the items listed and to add any new items they think are relevant. In the second round of the process, participants will be shown the distribution of scores for all stakeholder groups separately and asked to re-score. A final consensus meeting will be held with an expert panel and stakeholder representatives to review the guideline item list. Following the consensus meeting, a reporting guideline will be drafted and review and testing will be undertaken until the guideline is finalised. The final outcome will be the COS-STAR (Core Outcome Set-STAndards for Reporting) guideline for studies developing COS and a supporting explanatory document. To assess the credibility and usefulness of a COS, readers of a COS development report need complete, clear and transparent information on its methodology and proposed core set of outcomes. The COS-STAR guideline will potentially benefit all stakeholders in COS development: COS developers, COS users, e.g. trialists and systematic reviewers, journal editors, policy-makers and patient groups.

  10. Validation of a Brief Questionnaire Against Direct Observation to Assess Adolescents' School Lunchtime Beverage Consumption.

    PubMed

    Grummon, Anna H; Hampton, Karla E; Hecht, Amelie; Oliva, Ariana; McCulloch, Charles E; Brindis, Claire D; Patel, Anisha I

    Beverage consumption is an important determinant of youth health outcomes. Beverage interventions often occur in schools, yet no brief validated questionnaires exist to assess whether these efforts improve in-school beverage consumption. This study validated a brief questionnaire to assess beverage consumption during school lunch. Researchers observed middle school students' (n = 25) beverage consumption during school lunchtime using a standardized tool. After lunch, students completed questionnaires regarding their lunchtime beverage consumption. Kappa statistics compared self-reported with observed beverage consumption across 15 beverage categories. Eight beverages showed at least fair agreement (kappa [κ] > 0.20) for both type and amount consumed, with most showing substantial agreement (κ > 0.60). One beverage had high raw agreement but κ < 0.20. Six beverages had too few ratings to compute κ's. This brief questionnaire was useful for assessing school lunchtime consumption of many beverages and provides a low-cost tool for evaluating school-based beverage interventions. Copyright © 2017 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

  11. A quantitative assessment of patient and nurse outcomes of bedside nursing report implementation.

    PubMed

    Sand-Jecklin, Kari; Sherman, Jay

    2014-10-01

    To quantify quantitative outcomes of a practice change to a blended form of bedside nursing report. The literature identifies several benefits of bedside nursing shift report. However, published studies have not adequately quantified outcomes related to this process change, having either small or unreported sample sizes or not testing for statistical significance. Quasi-experimental pre- and postimplementation design. Seven medical-surgical units in a large university hospital implemented a blend of recorded and bedside nursing report. Outcomes monitored included patient and nursing satisfaction, patient falls, nursing overtime and medication errors. We found statistically significant improvements postimplementation in four patient survey items specifically impacted by the change to bedside report. Nursing perceptions of report were significantly improved in the areas of patient safety and involvement in care and nurse accountability postimplementation. However, there was a decline in nurse perception that report took a reasonable amount of time after bedside report implementation; contrary to these perceptions, there was no significant increase in nurse overtime. Patient falls at shift change decreased substantially after the implementation of bedside report. An intervening variable during the study period invalidated the comparison of medication errors pre- and postintervention. There was some indication from both patients and nurses that bedside report was not always consistently implemented. Several positive outcomes were documented in relation to the implementation of a blended bedside shift report, with few drawbacks. Nurse attitudes about report at the final data collection were more positive than at the initial postimplementation data collection. If properly implemented, nursing bedside report can result in improved patient and nursing satisfaction and patient safety outcomes. However, managers should involve staff nurses in the implementation process and

  12. When is exposure to a natural disaster traumatic? Comparison of a trauma questionnaire and disaster exposure inventory.

    PubMed

    Harville, Emily W; Jacobs, Marni; Boynton-Jarrett, Renée

    2015-01-01

    Few studies have compared the sensitivity of trauma questionnaires to disaster inventories for assessing the prevalence of exposure to natural disaster or associated risk for post-disaster psychopathology. The objective of this analysis was to compare reporting of disaster exposure on a trauma questionnaire (Brief Trauma Questionnaire [BTQ]) to an inventory of disaster experience. Between 2011 and 2014, a sample of 841 reproductive-aged southern Louisiana women were interviewed using the BTQ and completed a detailed inventory about exposure to hurricanes and flooding. Post-traumatic stress disorder (PTSD) symptomology was measured with the Post-Traumatic Stress Checklist, and depression with the Edinburgh Depression Scale. The single question addressing disaster exposure on the BTQ had a sensitivity of between 65% and 70% relative to the more detailed questions. Reporting disaster exposure on the BTQ was more likely for those who reported illness/injury due to a hurricane or flood (74%-77%) or danger (77-79%), compared to those who reported damage (69-71%) or evacuation (64-68%). Reporting disaster exposure on the BTQ was associated with depression (odds ratio [OR] 2.29, 95% confidence interval [CI] 1.43-3.68). A single question is unlikely to be useful for assessing the degree of exposure to disaster across a broad population, and varies in utility depending on the mental health outcome of interest: the single trauma question is useful for assessing depression risk.

  13. The Challenging Experience Questionnaire: Characterization of challenging experiences with psilocybin mushrooms

    PubMed Central

    Barrett, Frederick S.; Bradstreet, Matthew P.; Leoutsakos, Jeannie-Marie S.; Johnson, Matthew W.; Griffiths, Roland R.

    2017-01-01

    Acute adverse psychological reactions to classic hallucinogens (“bad trips”, or “challenging experiences”), while usually benign with proper screening, preparation, and support in controlled settings, remain a safety concern in uncontrolled settings (such as illicit use contexts). Anecdotal and case reports suggest potential adverse acute symptoms including affective (panic, depressed mood), cognitive (confusion, feelings of losing sanity), and somatic (nausea, heart palpitation) symptoms. Responses to items from several hallucinogen-sensitive questionnaires (Hallucinogen Rating Scale, the States of Consciousness Questionnaire, and the 5-Dimensional Altered States of Consciousness questionnaire) in an internet survey of challenging experiences with the classic hallucinogen psilocybin were used to construct and validate a Challenging Experience Questionnaire (CEQ). The stand-alone CEQ was then validated in a separate sample. Seven CEQ factors (grief, fear, death, insanity, isolation, physical distress, and paranoia) provide a phenomenological profile of challenging aspects of experiences with psilocybin. Factor scores were associated with the difficulty, meaningfulness, spiritual significance, and change in well-being attributed to the challenging experiences. The factor structure did not differ based on gender or prior struggle with anxiety or depression. The CEQ provides a basis for future investigation of predictors and outcomes of challenging experiences with psilocybin, and should be explored as a measure of challenging experiences with the broad class of classic hallucinogens. PMID:27856683

  14. Pectus patient information website has improved access to care and patient reported outcomes.

    PubMed

    Tikka, Theofano; Webb, Joanne; Agostini, Paula; Kerr, Amy; Mannion, Glenn; Steyn, Richard S; Bishay, Ehab; Kalkat, Maninder S; Rajesh, Pala B; Naidu, Babu

    2016-04-26

    Pectus is the most common congenital disorder. Awareness amongst primary care physicians and the general public is poor. NHS commissioning bodies plan to withdraw funding for this surgery because they deem a lack of sufficient evidence of benefit. The purpose of this study is to assess the effects of introducing a patient information website on referral and activity patterns and on patients reported outcomes. We produced an innovative information website, www.pectus.co.uk , accessible to the general public, providing information about pectus deformities; management options and advice about surgery. Referral patterns and number of cases where studied before and after the introduction of the website in 2010. Patients' satisfaction post-op was assessed using the Brompton's single step questionnaire (SSQ). The website had considerable traffic with 2179 hits in 2012, 4983 in 2013 and 7416 in 2014. This has led to 1421 contacts and 372 email enquiries. These emails have resulted in an increased number of patients who have been assessed and go on to have surgery. We asked 59 pectus excavatum patients who were operated from 2008 to 2014 to complete the SSQ. We received 32 replies. Eighty-four percent (16/19) of patients who visited the website and then underwent surgery, found the website useful. All patients scored satisfactorily in SSQ. Even though those who visited the website tended to be more satisfied with the surgical outcomes this did not reach statistical significance. This group of patients said that would have the operation again given the option compared to 76.9 % of the group who did not visit the website before surgery (p=0.031). Despite the fact that patients who visited the website experienced more post-operative complications were equally or more satisfied with post-operative outcomes. The overall SSQ obtainable score was not different for the two subgroups, being more widespread in the group that did not visit the website. The introduction of a pectus

  15. Standardising the reporting of outcomes in gastric cancer surgery trials: protocol for the development of a core outcome set and accompanying outcome measurement instrument set (the GASTROS study).

    PubMed

    Alkhaffaf, Bilal; Glenny, Anne-Marie; Blazeby, Jane M; Williamson, Paula; Bruce, Iain A

    2017-08-09

    Gastric cancer is one of the leading causes of cancer-related deaths worldwide. Whilst surgery is the mainstay of curative treatment, it is associated with significant risks. Surgical strategies for treating gastric cancer should be based on evidence from systematic reviews of well-designed randomised controlled trials. However, inconsistencies in the reporting of outcomes from these trials makes evidence synthesis unreliable. We present a protocol for an international consensus study to develop a standardised set of outcomes and measurement tools - a 'core outcome set' (COS) - to be used by all future trials examining therapeutic surgical interventions for gastric cancer. The GASTROS study aims to standardise the reporting of outcomes in gastric cancer surgery trials through an international consensus process of key stakeholders including health care professionals and patients. The first of three stages in the study will identify a 'long-list' of potentially important outcomes to be prioritised. These will be extracted from a systematic review of relevant academic literature and patient interviews. Stage 2 will comprise an eDelphi survey which will consider the views of patients, nurse specialists and surgeons to prioritise the most important outcomes. A meeting of stakeholder representatives will ratify the COS. Stage 3 will focus on identifying appropriate instruments to measure the prioritised outcomes by means of quality assessment of available measurement instruments and stakeholder consultation. This study aims to standardise the reporting of outcomes in future trials examining therapeutic surgical interventions for gastric cancer. It is anticipated that standardisation of outcome reporting in these surgical effectiveness trials will enhance the evidence base for clinical practice. Highlighting outcomes of greatest importance to patients will ensure that their perspectives are central to research in this field.

  16. Psychometric properties of self-reported questionnaires for the evaluation of symptoms and functional limitations in individuals with rotator cuff disorders: a systematic review.

    PubMed

    St-Pierre, Corinne; Desmeules, François; Dionne, Clermont E; Frémont, Pierre; MacDermid, Joy C; Roy, Jean-Sébastien

    2016-01-01

    To conduct a systematic review of the psychometric properties (reliability, validity and responsiveness) of self-report questionnaires used to assess symptoms and functional limitations of individuals with rotator cuff (RC) disorders. A systematic search in three databases (Cinahl, Medline and Embase) was conducted. Data extraction and critical methodological appraisal were performed independently by three raters using structured tools, and agreement was achieved by consensus. A descriptive synthesis was performed. One-hundred and twenty articles reporting on 11 questionnaires were included. All questionnaires were highly reliable and responsive to change, and showed construct validity; seven questionnaires also shown known-group validity. The minimal detectable change ranged from 6.4% to 20.8% of total score; only two questionnaires (American Shoulder and Elbow Surgeon questionnaire [ASES] and Upper Limb Functional Index [ULFI]) had a measurement error below 10% of global score. Minimal clinically important differences were established for eight questionnaires, and ranged from 8% to 20% of total score. Overall, included questionnaires showed acceptable psychometric properties for individuals with RC disorders. The ASES and ULFI have the smallest absolute error of measurement, while the Western Ontario RC Index is one of the most responsive questionnaires for individuals suffering from RC disorders. All included questionnaires are reliable, valid and responsive for the evaluation of individuals with RC disorders. As all included questionnaires showed good psychometric properties for the targeted population, the choice should be made according to the purpose of the evaluation and to the construct being evaluated by the questionnaire. The WORC, a RC-specific questionnaire, appeared to be more responsive. It should therefore be used to evaluate change in time. If the evaluation is time-limited, shorter questionnaires or short versions should be considered (such as

  17. Guideline for translation and national validation of the Quality of Life in Hand Eczema Questionnaire (QOLHEQ).

    PubMed

    Oosterhaven, Jart A F; Schuttelaar, Marie L A; Apfelbacher, Christian; Diepgen, Thomas L; Ofenloch, Robert F

    2017-08-01

    There is a need for well-developed and validated questionnaires to measure patient reported outcomes. The Quality of Life in Hand Eczema Questionnaire (QOLHEQ) is such a validated instrument measuring disease-specific health-related quality of life in hand eczema patients. A re-validation of measurement properties is required before an instrument is used in a new population. With the objective of arriving at a guideline for translation and national validation of the QOLHEQ, we have developed the design of a reference study on how to adequately assess measurement properties of the QOLHEQ based on interdisciplinary discussions and current standards. We present a step-by-step guideline to assess translation (including cross-cultural adaptation), scale structure, validity, reproducibility, responsiveness, and interpretability. We describe which outcomes should be reported for each measurement property, and give advice on how to calculate these. It is also specified which sample size is needed, how to deal with missing data, and which cutoff values should be applied for the measurement properties assessed during the validation process. In conclusion, this guideline, presenting a reference validation study for the QOLHEQ, creates the possibility to harmonize the national validation of the various language versions of the QOLHEQ. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  18. Variable reporting of functional outcomes and return to play in superior labrum anterior and posterior tear.

    PubMed

    Steinhaus, Michael E; Makhni, Eric C; Lieber, Adam C; Kahlenberg, Cynthia A; Gulotta, Lawrence V; Romeo, Anthony A; Verma, Nikhil N

    2016-11-01

    Outcomes assessments after superior labrum anterior and posterior (SLAP) tear/repair are highly varied, making it difficult to draw comparisons across the literature. This study examined the inconsistency in outcomes reporting in the SLAP tear literature. We hypothesize that there is significant variability in outcomes reporting and that although most studies may report return to play, time to return reporting will be highly variable. The PubMed, Medline, Scopus, and Embase databases were systematically reviewed for studies from January 2000 to December 2014 reporting outcomes after SLAP tear/repair. Two reviewers assessed each study, and those meeting inclusion criteria were examined for pertinent data. Outcomes included objective (range of motion, strength, clinical examinations, and imaging) and subjective (patient-reported outcomes, satisfaction, activities of daily living, and return to play) measures. Of the 56 included studies, 43% documented range of motion, 14% reported strength, and 16% noted postoperative imaging. There was significant variation in use of patient-reported outcomes measures, with the 3 most commonly noted measures reported in 20% to 55% of studies. Return to play was noted in 75% of studies, and 23% reported time to return, with greater rates in elite athletes. Eleven studies (20%) did not report follow-up or noted data with <12 months of follow-up. The SLAP literature is characterized by substantial variability in outcomes reporting, with time to return to play noted in few studies. Efforts to standardize outcomes reporting would facilitate comparisons across the literature and improve our understanding of the prognosis of this injury. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

  19. Brief Report: Methods for Collecting Sexual Behaviour Information from South African Adolescents--A Comparison of Paper versus Personal Digital Assistant Questionnaires

    ERIC Educational Resources Information Center

    Jaspan, Heather B.; Flisher, Alan J.; Myer, Landon; Mathews, Catherine; Seebregts, Chris; Berwick, Jessica R.; Wood, Robin; Bekker, Linda-Gail

    2007-01-01

    Reporting bias in adolescent behavioural research may be overcome with the use of personal digital assistants (PDA) or other computer based technologies. However, there is little insight into the use of these tools among adolescents in low resource settings. We compared self-administered paper questionnaires with PDA questionnaires to collect…

  20. 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…

  1. Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data

    PubMed Central

    Wieseler, Beate; Wolfram, Natalia; McGauran, Natalie; Kerekes, Michaela F.; Vervölgyi, Volker; Kohlepp, Petra; Kamphuis, Marloes; Grouven, Ulrich

    2013-01-01

    Background Access to unpublished clinical study reports (CSRs) is currently being discussed as a means to allow unbiased evaluation of clinical research. The Institute for Quality and Efficiency in Health Care (IQWiG) routinely requests CSRs from manufacturers for its drug assessments. Our objective was to determine the information gain from CSRs compared to publicly available sources (journal publications and registry reports) for patient-relevant outcomes included in IQWiG health technology assessments (HTAs) of drugs. Methods and Findings We used a sample of 101 trials with full CSRs received for 16 HTAs of drugs completed by IQWiG between 15 January 2006 and 14 February 2011, and analyzed the CSRs and the publicly available sources of these trials. For each document type we assessed the completeness of information on all patient-relevant outcomes included in the HTAs (benefit outcomes, e.g., mortality, symptoms, and health-related quality of life; harm outcomes, e.g., adverse events). We dichotomized the outcomes as “completely reported” or “incompletely reported.” For each document type, we calculated the proportion of outcomes with complete information per outcome category and overall. We analyzed 101 trials with CSRs; 86 had at least one publicly available source, 65 at least one journal publication, and 50 a registry report. The trials included 1,080 patient-relevant outcomes. The CSRs provided complete information on a considerably higher proportion of outcomes (86%) than the combined publicly available sources (39%). With the exception of health-related quality of life (57%), CSRs provided complete information on 78% to 100% of the various benefit outcomes (combined publicly available sources: 20% to 53%). CSRs also provided considerably more information on harms. The differences in completeness of information for patient-relevant outcomes between CSRs and journal publications or registry reports (or a combination of both) were statistically

  2. Setting the vision: applied patient-reported outcomes and smart, connected digital healthcare systems to improve patient-centered outcomes prediction in critical illness.

    PubMed

    Wysham, Nicholas G; Abernethy, Amy P; Cox, Christopher E

    2014-10-01

    Prediction models in critical illness are generally limited to short-term mortality and uncommonly include patient-centered outcomes. Current outcome prediction tools are also insensitive to individual context or evolution in healthcare practice, potentially limiting their value over time. Improved prognostication of patient-centered outcomes in critical illness could enhance decision-making quality in the ICU. Patient-reported outcomes have emerged as precise methodological measures of patient-centered variables and have been successfully employed using diverse platforms and technologies, enhancing the value of research in critical illness survivorship and in direct patient care. The learning health system is an emerging ideal characterized by integration of multiple data sources into a smart and interconnected health information technology infrastructure with the goal of rapidly optimizing patient care. We propose a vision of a smart, interconnected learning health system with integrated electronic patient-reported outcomes to optimize patient-centered care, including critical care outcome prediction. A learning health system infrastructure integrating electronic patient-reported outcomes may aid in the management of critical illness-associated conditions and yield tools to improve prognostication of patient-centered outcomes in critical illness.

  3. AMCP Partnership Forum: Improving Quality, Value, and Outcomes with Patient-Reported Outcomes.

    PubMed

    2018-03-01

    Patient-reported outcomes (PROs), which provide a direct measure of a patient's health status or treatment preferences, represent a key component of the shift toward patient-centered health care. PROs can measure the state of a patient's disease-specific and overall health throughout the care continuum, enabling them to have a variety of uses for key health care stakeholders. Currently, PROs are used in drug development, aligning patient and clinician goals in care, quality-of-care measures, and coverage and reimbursement decisions. While there have been significant strides by key health care stakeholders to further the development and use of PROs, there are a number of challenges limiting more widespread use. In light of these current challenges and the potential for PROs to improve health care quality and value, on October 19, 2017, the Academy of Managed Care Pharmacy convened a forum of key stakeholders representing patients, payers, providers, government, and pharmaceutical companies to discuss and identify solutions to the current challenges and barriers to further use of PROs. These discussions informed the development of participants' ideal future state in which PROs maximize the goals of all health care stakeholders and the actionable steps required to make the future state a reality. While stakeholders shared unique perspectives throughout the forum, they had consensus on 2 overarching issues: the importance of PROs in defining value, improving patient care, and implementing value-based payment models and the need for strong organizational and operational systems to achieve optimal adoption and use. Participants identified several key challenges in PRO use and adoption: achieving a representative patient population, inclusion of PRO data in medication labels, the necessity for both standardized and customizable PROs, and operational and organizational barriers to collecting and analyzing PROs. To overcome these challenges, participants recommended that

  4. Personality, Organizational Orientations and Self-Reported Learning Outcomes

    ERIC Educational Resources Information Center

    Bamber, David; Castka, Pavel

    2006-01-01

    Purpose: To identify competencies connecting personality, organizational orientations and self-reported learning outcomes (as measured by concise Likert-type scales), for individuals who are learning for their organizations. Design/methodology/approach: Five concise factor scales were constructed to represent aspects of personality. Three further…

  5. Development of a core outcome set for research and audit studies in reconstructive breast surgery.

    PubMed

    Potter, S; Holcombe, C; Ward, J A; Blazeby, J M

    2015-10-01

    Appropriate outcome selection is essential if research is to guide decision-making and inform policy. Systematic reviews of the clinical, cosmetic and patient-reported outcomes of reconstructive breast surgery, however, have demonstrated marked heterogeneity, and results from individual studies cannot be compared or combined. Use of a core outcome set may improve the situation. The BRAVO study developed a core outcome set for reconstructive breast surgery. A long list of outcomes identified from systematic reviews and stakeholder interviews was used to inform a questionnaire survey. Key stakeholders defined as individuals involved in decision-making for reconstructive breast surgery, including patients, breast and plastic surgeons, specialist nurses and psychologists, were sampled purposively and sent the questionnaire (round 1). This asked them to rate the importance of each outcome on a 9-point Likert scale from 1 (not important) to 9 (extremely important). The proportion of respondents rating each item as very important (score 7-9) was calculated. This was fed back to participants in a second questionnaire (round 2). Respondents were asked to reprioritize outcomes based on the feedback received. Items considered very important after round 2 were discussed at consensus meetings, where the core outcome set was agreed. A total of 148 items were combined into 34 domains within six categories. Some 303 participants (51·4 per cent) (215 (49·5 per cent) of 434 patients; 88 (56·4 per cent) of 156 professionals) completed and returned the round 1 questionnaire, and 259 (85·5 per cent) reprioritized outcomes in round 2. Fifteen items were excluded based on questionnaire scores and 19 were carried forward to the consensus meetings, where a core outcome set containing 11 key outcomes was agreed. The BRAVO study has used robust consensus methodology to develop a core outcome set for reconstructive breast surgery. Widespread adoption by the reconstructive community will

  6. The early development phases of a European Organisation for Research and Treatment of Cancer (EORTC) module to assess patient reported outcomes (PROs) in women undergoing breast reconstruction.

    PubMed

    Thomson, H J; Winters, Z E; Brandberg, Y; Didier, F; Blazeby, J M; Mills, J

    2013-03-01

    A comprehensive evaluation of breast reconstruction (BRR) surgery includes measurement of patient reported outcomes (PROs). There is, however, a lack of validated BRR-specific PRO measures (PROMs) that adequately assess relevant issues. This study is developing a European Organisation for Research and Treatment of Cancer (EORTC) questionnaire/module specific for PROs in BRR to supplement the cancer-core and breast cancer EORTC questionnaires, respectively: the QLQ-C30 and QLQ-BR23. Phases I and II of questionnaire development followed EORTC guidelines including a systematic literature review to identify all potential 'issues' (concepts relevant to PROs) and semi-structured interviews with 89 patients and 9 European multi-disciplinary health care professionals (HCPs) (Sweden, Italy and the United Kingdom [UK]). Interviewers asked participants the 'relevance' of outcomes identified in the literature and captured additional 'issues' of importance. The literature search and interviews of patients and HCPs yielded 69 issues relating to BRR operationalised into 31 provisional items (single questions) for the module, which was conceptualised to contain five scales: treatment/surgery related symptoms (affecting the shoulder, arm and reconstructed breast), body image, sexuality, cosmetic outcomes (pertaining to three areas: breast, donor site and nipple) and overall satisfaction. The provisional development of the EORTC BRR module has 31 items addressing issues of importance to patients as well as HCPs. Further international testing is underway as a UK National Cancer Research Network trial to ensure that this PROM will be psychometrically and clinically robust and applicable for use in clinical trials, cohort studies, national audit and clinical practice. Copyright © 2012 Elsevier Ltd. All rights reserved.

  7. Pharmacists' interventions on clinical asthma outcomes: a systematic review.

    PubMed

    Garcia-Cardenas, Victoria; Armour, Carol; Benrimoj, Shalom I; Martinez-Martinez, Fernando; Rotta, Inajara; Fernandez-Llimos, Fernando

    2016-04-01

    The objective of this systematic review was to evaluate the impact of pharmacists' interventions on clinical asthma outcomes on adult patients and to identify the outcome indicators used.PubMed, Scopus, Web of Science and Scielo were searched. Studies addressing pharmacists' interventions on adult asthma patients reporting clinical asthma outcomes were incorporated.11 clinical outcomes were identified in 21 studies. 10 studies measured the impact of the intervention on asthma control. Randomised controlled trials (RCT) and non-RCTs found positive results in percentages of controlled patients and Asthma Control Questionnaire (ACQ) scores. Discordant results were found for Asthma Control Test results. Asthma severity was assessed in four studies. One RCT found a significant decrease in the percentage of severe patients; two non-RCTs found significant improvements in severity scores. 11 studies reported pulmonary function indicators, showing inconsistent results. Eight studies measured asthma symptoms; three RCTs and four non-RCTs showed significant improvements.RCTs and non-RCTs generated similar results for most outcomes. Based on the evidence generated by RCTs, pharmacists' have a positive impact on the percentage of controlled patients, ACQ scores, severity and symptoms. Future research should report using the core outcome set of indicators established for asthma (PROSPERO CRD42014007019). Copyright ©ERS 2016.

  8. Measuring nurses' perception of work environment: a scoping review of questionnaires.

    PubMed

    Norman, Rebecka Maria; Sjetne, Ingeborg Strømseng

    2017-01-01

    Nurses' work environment has been shown to be associated with quality of care and organizational outcomes. In order to monitor the work environment, it is useful for all stakeholders to know the questionnaires that assess or evaluate conditions for delivering nursing care. The aim of this article is: to review the literature for assessed survey questionnaires that measure nurses' perception of their work environment, make a brief assessment, and map the content domains included in a selection of questionnaires. The search included electronic databases of internationally published literature, international websites, and hand searches of reference lists. Eligible papers describing a questionnaire had to be; a) suitable for nurses working in direct care in general hospitals, nursing homes or home healthcare settings; and b) constructed to measure work environment characteristics that are amenable to change and related to patient and organizational outcomes; and c) presented along with an assessment of their measurement properties. The search yielded 5077 unique articles. For the final synthesis, 65 articles met inclusion criteria, consisting of 34 questionnaires measuring nursing work environments in different settings. Most of the questionnaires that we found were developed, and tested, for registered nurses in a general hospital setting. Six questionnaires were developed specifically for use in nursing home settings and one for home healthcare. The content domains covered by the questionnaires were both overlapping and unique and the terminology in use was inconsistent. The most common content domains in the work environment questionnaires were supportive managers, collaborative relationships with peers, busyness, professional practice and autonomy. The findings from this review enhance the understanding of how "work environment" can be measured by an overview of existing questionnaires and domains. Our results indicate that there are very many work environment

  9. Surgical Management of Adult-acquired Buried Penis: Impact on Urinary and Sexual Quality of Life Outcomes.

    PubMed

    Theisen, Katherine M; Fuller, Thomas W; Rusilko, Paul

    2018-06-01

    To assess postoperative patient-reported quality of life outcomes after surgical management of adult-acquired buried penis (AABP). We hypothesize that surgical treatment of AABP results in improvements in urinary and sexual quality of life. Patients that underwent surgical treatment of AABP were retrospectively identified. The Expanded Prostate Cancer Index (EPIC) questionnaire was completed at ≥3 months postoperatively, and completed retrospectively to define preoperative symptoms. EPIC is validated for local treatment of prostate cancer. Urinary and sexual domains were utilized. Questions are scored on a 5-point Likert scale, with higher scores indicating better quality of life. Preoperative scores were compared with postoperative scores. Sixteen patients completed pre- and postoperative questionnaires. Mean time from surgery to questionnaire was 12.6 months. There was a significant improvement in 10 of 12 urinary domain questions and 10 of 13 sexual domain questions. Fourteen of 16 patients (87.5%) reported significant improvement in overall sexual function (median score changed from 1.5 to 5, P <.0001). Similarly, 14 of 16 patients (87.5%) reported significant improvement in overall urinary function (median score changed from 1 to 4, P <.0001). AABP is a challenging condition to treat and often requires surgical intervention to improve hygiene and function. There are limited data on patient-reported quality of life outcomes. We found that surgical management of AABP results in significant improvements in both urinary and sexual quality of life outcomes. Copyright © 2018 Elsevier Inc. All rights reserved.

  10. Obesity-related adipokines predict patient-reported shoulder pain.

    PubMed

    Gandhi, Rajiv; Perruccio, Anthony V; Rizek, Randy; Dessouki, Omar; Evans, Heather M K; Mahomed, Nizar N

    2013-01-01

    Increasingly, an inflammatory modulating effect of adipokines within synovial joints is being recognized. To date, there has been no work examining a potential association between the presence of adipokines in the shoulder and patient-reported outcomes. This study undertakes an investigation assessing these potential links. 50 osteoarthritis patients scheduled for shoulder surgery completed a pre-surgery questionnaire capturing demographic information including validated, patient-reported function (Disabilities of the Arm, Shoulder, and Hand questionnaire) and pain (Short Form McGill Pain Questionnaire) measures. Synovial fluid (SF) samples were analyzed for leptin, adiponectin, and resistin levels using Milliplex MAP assays. Linear regression modeling was used to assess the association between adipokine levels and patient-reported outcomes, adjusted for age, sex, BMI, and disease severity. 54% of the cohort was female (n = 27). The mean age (SD) of the sample was 62.9 (9.9) years and the mean BMI (SD) was 28.1 (5.4) kg/m(2). From regression analyses, greater SF leptin and adiponectin levels, but not regarding resistin, were found to be associated with greater pain (p < 0.05). Adipokine levels were not associated with functional outcome scores. The identified association between shoulder-derived SF leptin and adiponectin and shoulder pain is likely explained by the pro-inflammatory characteristics of the adipokines and represents potentially important therapeutic targets. © 2013 S. Karger GmbH, Freiburg.

  11. Systematic review of systemic sclerosis-specific instruments for the EULAR Outcome Measures Library: An evolutional database model of validated patient-reported outcomes.

    PubMed

    Ingegnoli, Francesca; Carmona, Loreto; Castrejon, Isabel

    2017-04-01

    The EULAR Outcome Measures Library (OML) is a freely available database of validated patient-reported outcomes (PROs). The aim of this study was to provide a comprehensive review of validated PROs specifically developed for systemic sclerosis (SSc) to feed the EULAR OML. A sensitive search was developed in Medline and Embase to identify all validation studies, cohort studies, reviews, or meta-analyses in which the objective were the development or validation of specific PROs evaluating organ involvement, disease activity or damage in SSc. A reviewer screened title and abstracts, selected the studies, and collected data concerning validation using ad hoc forms based on the COSMIN checklist. From 13,140 articles captured, 74 met the predefined criteria. After excluding two instruments as they were unavailable in English the selected 23 studies provided information on seven SSc-specific PROs on different SSc domains: burden of illness (symptom burden index), functional status (Scleroderma Assessment Questionnaire), functional ability (scleroderma Functional Score), Raynaud's phenomenon (Raynaud's condition score), mouth involvement (Mouth Handicap in SSc), gastro-intestinal involvement (University of California Los Angeles-Scleroderma Clinical Trial Consortium Gastro-Intestinal tract 2.0), and skin involvement (skin self-assessment). Each of them is partially validated and has different psychometric requirements. Seven SSc-specific PROs have a minimum validation and were included in the EULAR OML. Further development in the area of disease-specific PROs in SSc is warranted. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. Priorities for Cardiovascular Outcomes Research: A Report of the National Heart, Lung, and Blood Institute's Centers for Cardiovascular Outcomes Research Working Group.

    PubMed

    Khazanie, Prateeti; Krumholz, Harlan M; Kiefe, Catarina I; Kressin, Nancy R; Wells, Barbara; Wang, Tracy Y; Peterson, Eric D

    2017-07-01

    The Centers for Cardiovascular Outcomes Research (CCORs) held a meeting to review how cardiovascular outcomes research had evolved in the decade since the National Heart, Lung, and Blood Institute 2004 working group report and to consider future directions. The conference involved representatives from governmental agencies, outcomes research thought leaders, and public and private healthcare partners. The main purposes of this meeting were to (1) advance collaborative high-yield, high-impact outcomes research; (2) identify priorities and barriers to important cardiovascular outcomes research; and (3) define future needs for the field. This report highlights the key topics covered during the meeting, including an examination of the recent history of outcomes research, an evaluation of the current academic climate, and a vision for the future of cardiovascular outcomes research. © 2017 American Heart Association, Inc.

  13. The reasons for Chinese nursing staff to report adverse events: a questionnaire survey.

    PubMed

    Hong, Su; Li, QiuJie

    2017-04-01

    To investigate the impact of nurses' perception of patient safety culture and adverse event reporting, and demographic factors on adverse event reporting in Chinese hospitals. Accurate and timely adverse event reporting is integral in promoting patient safety and professional learning around the incident. In a cross-sectional survey, a sample of 919 nurses completed a structured questionnaire composed of two validated instruments measuring nurses' perception of patient safety culture and adverse event reporting. Associations between the variables were examined using multiple linear regression analysis. The positive response rates of five dimensions of the Patient Safety Culture Assessment Scale varied from 47.55% to 80.62%. The accuracy rate of Adverse Event Reporting Perception Scale was 63.16%. Five hundred and thirty-one (58.03%) nurses did not report adverse event in past 12 months. Six variables were found to be associated with nurses' adverse event reporting: total work experience (P = 0.003), overall patient safety culture score (P < 0.001), safety climate (P < 0.001), teamwork climate (P < 0.001), overall the adverse event reporting perception scale score (P = 0.003) and importance or reporting (P = 0.002). The results confirmed that improvements in the patient safety culture and nurses' perception of adverse event reporting were related to an increase in voluntary adverse event reporting. The knowledge of adverse event reporting should be integrated into the patient safety curriculum. Interventions that target a specific domain are necessary to improve the safety culture. © 2017 John Wiley & Sons Ltd.

  14. Treatment outcomes and patient-reported quality of life after orthognathic surgery with computer-assisted 2- or 3-dimensional planning: A randomized double-blind active-controlled clinical trial.

    PubMed

    Bengtsson, Martin; Wall, Gert; Larsson, Pernilla; Becktor, Jonas P; Rasmusson, Lars

    2018-06-01

    Thorough treatment planning is essential for a good clinical outcome in orthognathic treatment. The planning is often digital. Both 2-dimensional (2D) and 3-dimensional (3D) software options are available. The aim of this randomized 2-arm parallel double-blinded active-controlled clinical trial was to compare the outcomes of computer-based 2D and 3D planning techniques according to patient-reported health related quality of life. The hypothesis was that a 3D technique would give a better treatment outcome compared with a 2D technique. Orthognathic treatment for 62 subjects, aged 18 to 28 years, with severe Class III malocclusion was planned with both 2D and 3D techniques. After treatment planning but before surgery, the patients were randomly allocated via blind collection of 1 enveloped card for each subject in a 1:1 ratio to the test (3D) or the control (2D) group. Thus, the intervention was according to which planning technique was used. The primary outcome was patient-reported outcome measures. The secondary outcome was relationship between patient-reported outcome measures and cephalometric accuracy. Questionnaires on the patient's health-related quality of life (HRQoL) were distributed preoperatively and 12 months after surgical treatment. The questionnaires were coded, meaning blinding throughout the analysis. Differences between groups were tested with the Fisher permutation test. The HRQoL was also compared with measurements of cephalometric accuracy for the 2 groups. Three subjects were lost to clinical follow-up, leaving 57 included. Of these, 55 subjects completed the questionnaires, 28 in the 2D and 27 in the 3D groups. No statistically significant difference regarding HRQoL was found between the studied planning techniques: the Oral Health Impact Profile total showed -3.69 (95% confidence interval, -19.68 to 12.30). Consistent results on HRQoL and cephalometric accuracy showed a difference between pretreatment and posttreatment that increased in

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

    ERIC Educational Resources Information Center

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

    2008-01-01

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

  16. Quality of patient-reported outcome reporting across cancer randomized controlled trials according to the CONSORT patient-reported outcome extension: A pooled analysis of 557 trials.

    PubMed

    Efficace, Fabio; Fayers, Peter; Pusic, Andrea; Cemal, Yeliz; Yanagawa, Jane; Jacobs, Marc; la Sala, Andrea; Cafaro, Valentina; Whale, Katie; Rees, Jonathan; Blazeby, Jane

    2015-09-15

    The main objectives of this study were to identify the number of randomized controlled trials (RCTs) including a patient-reported outcome (PRO) endpoint across a wide range of cancer specialties and to evaluate the completeness of PRO reporting according to the Consolidated Standards of Reporting Trials (CONSORT) PRO extension. RCTs with a PRO endpoint that had been performed across several cancer specialties and published between 2004 and 2013 were considered. Studies were evaluated on the basis of previously defined criteria, including the CONSORT PRO extension and the Cochrane Collaboration's tool for assessing the risk of bias of RCTs. Analyses were also conducted by the type of PRO endpoint (primary vs secondary) and by the cancer disease site. A total of 56,696 potentially eligible records were scrutinized, and 557 RCTs with a PRO evaluation, enrolling 254,677 patients overall, were identified. PROs were most frequently used in RCTs of breast (n = 123), lung (n = 85), and colorectal cancer (n = 66). Overall, PROs were secondary endpoints in 421 RCTs (76%). Four of 6 evaluated CONSORT PRO items were documented in less than 50% of the RCTs. The level of reporting was higher in RCTs with a PRO as a primary endpoint. The presence of a supplementary report was the only statistically significant factor associated with greater completeness of reporting for both RCTs with PROs as primary endpoints (β = .19, P = .001) and RCTs with PROs as secondary endpoints (β = .30, P < .001). Implementation of the CONSORT PRO extension is equally important across all cancer specialties. Its use can also contribute to revealing the robust PRO design of some studies, which might be obscured by poor outcome reporting. © 2015 American Cancer Society.

  17. Development of a disease-specific quality of life questionnaire in Addison's disease.

    PubMed

    Løvås, Kristian; Curran, Suzanne; Oksnes, Marianne; Husebye, Eystein S; Huppert, Felicia A; Chatterjee, V Krishna K

    2010-02-01

    Patients with Addison's disease reproducibly self-report impairment in specific dimensions of general well-being questionnaires, suggesting particular deficiencies in health-related quality-of-life (HRQoL). We sought to develop an Addison's disease-specific questionnaire (AddiQoL) that could better quantify altered well-being and treatment effects. Design, Setting, Patients, Intervention, and Outcomes: We reviewed the literature to identify HRQoL issues in Addison's disease and interviewed patients and their partners in-depth to explore various symptom domains. A list of items was generated, and nine expert clinicians and five expert patients assessed the list for impact and clarity. A preliminary questionnaire was presented to 100 Addison's outpatients; the number of items was reduced after analysis of the distribution of the responses. The final questionnaire responses were assessed by Cronbach's alpha and Rasch analysis. Published studies of HRQoL in Addison's disease indicated reduced vitality and general health perception and limitations in physical and emotional functioning. In-depth interviews of 14 patients and seven partners emphasized the impact of the disease on the emotional domain. Seventy HRQoL items were generated; after the expert consultation process and pretesting in 100 patients, the number of items was reduced to 36. Eighty-six patients completed the final questionnaire; the responses showed high internal consistency with Cronbach's alpha 0.95 and Person Separation Index 0.94 (Rasch analysis). We envisage AddiQoL having utility in trials of hormone replacement and management of patients with Addison's disease, analogous to similar questionnaires in GH deficiency (AGHDA) and acromegaly (AcroQoL).

  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 Long-Term Conditions Questionnaire: conceptual framework and item development.

    PubMed

    Peters, Michele; Potter, Caroline M; Kelly, Laura; Hunter, Cheryl; Gibbons, Elizabeth; Jenkinson, Crispin; Coulter, Angela; Forder, Julien; Towers, Ann-Marie; A'Court, Christine; Fitzpatrick, Ray

    2016-01-01

    To identify the main issues of importance when living with long-term conditions to refine a conceptual framework for informing the item development of a patient-reported outcome measure for long-term conditions. Semi-structured qualitative interviews (n=48) were conducted with people living with at least one long-term condition. Participants were recruited through primary care. The interviews were transcribed verbatim and analyzed by thematic analysis. The analysis served to refine the conceptual framework, based on reviews of the literature and stakeholder consultations, for developing candidate items for a new measure for long-term conditions. Three main organizing concepts were identified: impact of long-term conditions, experience of services and support, and self-care. The findings helped to refine a conceptual framework, leading to the development of 23 items that represent issues of importance in long-term conditions. The 23 candidate items formed the first draft of the measure, currently named the Long-Term Conditions Questionnaire. The aim of this study was to refine the conceptual framework and develop items for a patient-reported outcome measure for long-term conditions, including single and multiple morbidities and physical and mental health conditions. Qualitative interviews identified the key themes for assessing outcomes in long-term conditions, and these underpinned the development of the initial draft of the measure. These initial items will undergo cognitive testing to refine the items prior to further validation in a survey.

  20. The Long-Term Conditions Questionnaire: conceptual framework and item development

    PubMed Central

    Peters, Michele; Potter, Caroline M; Kelly, Laura; Hunter, Cheryl; Gibbons, Elizabeth; Jenkinson, Crispin; Coulter, Angela; Forder, Julien; Towers, Ann-Marie; A’Court, Christine; Fitzpatrick, Ray

    2016-01-01

    Purpose To identify the main issues of importance when living with long-term conditions to refine a conceptual framework for informing the item development of a patient-reported outcome measure for long-term conditions. Materials and methods Semi-structured qualitative interviews (n=48) were conducted with people living with at least one long-term condition. Participants were recruited through primary care. The interviews were transcribed verbatim and analyzed by thematic analysis. The analysis served to refine the conceptual framework, based on reviews of the literature and stakeholder consultations, for developing candidate items for a new measure for long-term conditions. Results Three main organizing concepts were identified: impact of long-term conditions, experience of services and support, and self-care. The findings helped to refine a conceptual framework, leading to the development of 23 items that represent issues of importance in long-term conditions. The 23 candidate items formed the first draft of the measure, currently named the Long-Term Conditions Questionnaire. Conclusion The aim of this study was to refine the conceptual framework and develop items for a patient-reported outcome measure for long-term conditions, including single and multiple morbidities and physical and mental health conditions. Qualitative interviews identified the key themes for assessing outcomes in long-term conditions, and these underpinned the development of the initial draft of the measure. These initial items will undergo cognitive testing to refine the items prior to further validation in a survey. PMID:27621678

  1. Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer.

    PubMed

    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

    2014-05-01

    To determine the effects of bevacizumab on patient-reported outcomes (PROs; secondary end point) in the AURELIA trial. 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. 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. Bevacizumab increased the proportion of patients achieving a 15% improvement in patient-reported abdominal/GI symptoms during chemotherapy for platinum-resistant ovarian cancer.

  2. Patient empowerment: a systematic review of questionnaires measuring empowerment in cancer patients.

    PubMed

    Eskildsen, Nanna Bjerg; Joergensen, Clara Ruebner; Thomsen, Thora Grothe; Ross, Lone; Dietz, Susanne Malchau; Groenvold, Mogens; Johnsen, Anna Thit

    2017-02-01

    There is an increased attention to and demand for patient empowerment in cancer treatment and follow-up programs. Patient empowerment has been defined as feeling in control of or having mastery in relation to cancer and cancer care. This calls for properly developed questionnaires assessing empowerment from the user perspective. The aim of this review was to identify questionnaires and subscales measuring empowerment and manifestations of empowerment among cancer patients. We conducted a systematic search of the PubMed, PsycINFO and CINAHL databases. Empowerment and multiple search terms associated with empowerment were included. We included peer-reviewed articles published in English, which described questionnaires measuring empowerment or manifestations of empowerment in a cancer setting. In addition, the questionnaire had to be a patient-reported outcome measure for adult cancer patients. Database searches identified 831 records. Title and abstract screening resulted in 482 records being excluded. The remaining 349 full text articles were retrieved and assessed for eligibility. This led to the inclusion of 33 individual instruments measuring empowerment and manifestations of empowerment. Of these, only four were specifically developed to measure empowerment, and two were originally developed for the cancer setting, whereas the remaining two were developed elsewhere, but adapted to the cancer setting. The other 29 questionnaires were not intended to measure the concept of empowerment, but focused on patient-centered care, patient competence, self-efficacy, etc. However, they were included because part of the instrument (at least five items) was considered to measure empowerment or manifestations of empowerment. Our study provides an overview of the available questionnaires, which can be used by researchers and practitioners who wish to measure the concept of empowerment among cancer patients. Very few questionnaires were explicitly developed to explore

  3. Hand therapist use of patient report outcome (PRO) in practice: a survey study.

    PubMed

    Valdes, Kristin; MacDermid, Joy; Algar, Lori; Connors, Brian; Cyr, Lisa M; Dickmann, Sharon; Lucado, Ann M; Naughton, Nancy

    2014-01-01

    The purpose of this survey was to gain greater insight into hand therapists' use of Patient Report Outcome (PRO) measures. An 11-question survey that evaluated therapists' perceptions, preferences, and patterns of use of patient report outcome measures was sent to members of ASHT. A total of 633 ASHT members participated in the survey study. A large majority of participants (92%) responded affirmatively to using a PRO measure in practice. The DASH was reported as the most frequently used measure (90%). The majority of therapists (84%) discuss the results of the outcome measurement score with their patients. Of the participants who use more than one outcome measure, 44% report that this allows them to better establish their patient's functional and physical limitations. The findings in this study suggest that a large percentage of hand therapists are currently including a PRO measure in their hand therapy practice. Copyright © 2014 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

  4. Symptoms and Satisfaction of Patients in the Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL) Studies.

    PubMed

    Eydelman, Malvina; Hilmantel, Gene; Tarver, Michelle E; Hofmeister, Elizabeth M; May, Jeanine; Hammel, Keri; Hays, Ron D; Ferris, Frederick

    2017-01-01

    Patient-reported outcomes should be collected using validated questionnaires prior to and following laser in situ keratomileusis (LASIK) surgery. To report the frequency of patient-reported visual symptoms, dry eye symptoms, satisfaction with vision, and satisfaction with LASIK surgery in the Patient-Reported Outcomes With LASIK (PROWL) studies. The PROWL-1 and PROWL-2 studies were prospective, observational studies conducted from September 13, 2011, to June 27, 2014. The PROWL-1 study was a single-military center study of 262 active-duty Navy personnel 21 to 52 years of age. The PROWL-2 study was a study of 312 civilians 21 to 57 years of age conducted at 5 private practice and academic centers. The LASIK surgery and the postoperative care were performed based on the usual practice and clinical judgment at the site. Participants completed a self-administered, web-based questionnaire, preoperatively and postoperatively at 1 and 3 months (the PROWL-1 and -2 studies) and at 6 months (the PROWL-2 study). Participants underwent LASIK surgery for myopia, hyperopia, and/or astigmatism. Visual symptoms (double images, glare, halos, and/or starbursts), dry eye symptoms, participant satisfaction (with vision and LASIK surgery), and clinical measures (visual acuity, refractive error, and slitlamp and posterior segment eye examination findings) were assessed preoperatively and at 1, 3, and 6 months postoperatively. A total of 262 participants were enrolled in the PROWL-1 study (mean [SD] age, 29.1 [6.1] years), and a total of 312 participants were enrolled in the PROWL-2 study (mean [SD] age, 31.5 [7.3] years). Visual symptoms and dissatisfaction with vision were common preoperatively. Overall, the prevalence of visual symptoms and dry eye symptoms decreased, although a substantial percentage of participants reported new visual symptoms after surgery (43% [95% CI, 31%-55%] from the PROWL-1 study and 46% [95% CI, 33%-58%] from the PROWL-2 study at 3 months). The percentages of

  5. Patient questionnaires in rheumatoid arthritis: advantages and limitations as a quantitative, standardized scientific medical history.

    PubMed

    Pincus, Theodore; Yazici, Yusuf; Bergman, Martin J

    2009-11-01

    In many chronic diseases, objective gold standard measures such as blood pressure, cholesterol, and bone densitometry often provide most of the information used to establish a diagnosis and guide therapy. By contrast, in inflammatory rheumatic diseases, information from a patient history usually is considerably more prominent in clinical management. Patient history data can be recorded as standardized, quantitative scientific data through use of validated self-reported questionnaires. Patient questionnaires address the primary concerns of patients and their families. Questionnaire scores distinguish active from control treatments in clinical trials at similar levels to swollen and tender joint counts or laboratory tests. Patient questionnaire data are correlated significantly with joint counts, radiographic scores, and laboratory tests, but usually are far more significant than these measures in the prognosis of severe outcomes of rheumatoid arthritis (RA), including work disability, costs, and premature death. Limitations of patient questionnaires are based on cultural features involving variation in responses among ethnic groups, and a need for translation, although translated questionnaires can be as valuable as a translator. Patient questionnaires do not replace further medical history, physical examination, laboratory tests, and imaging data, and they require interpretation in a context of these standard sources of information at any clinical encounter. Patient questionnaires are useful to monitor patient status in usual clinical care, with almost no effort on the part of the physician and staff if distributed by the receptionist in the infrastructure of office practice.

  6. Factor Structure and Reliability of the 2008 and 2009 SERU/UCUES Questionnaire Core. SERU Project Technical Report

    ERIC Educational Resources Information Center

    Chatman, Steve

    2009-01-01

    This technical report summarizes the third independent factor analysis of the SERU/UCUES questionnaire responses of students with majors. The 2009 solution employed the same quantitative analysis used in the prior solutions--varimax orthogonal rotation to determine principal components followed by promax oblique rotation to identify…

  7. 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.

  8. Test-Retest Reliability of the Parent Behavior Importance Questionnaire-Revised and the Parent Behavior Frequency Questionnaire-Revised

    ERIC Educational Resources Information Center

    Mowder, Barbara A.; Shamah, Renee

    2011-01-01

    This study evaluated the test-retest reliability of two parenting measures: the Parent Behavior Importance Questionnaire-Revised (PBIQ-R) and Parent Behavior Frequency Questionnaire-Revised (PBFQ-R). These self-report parenting behavior assessment measures may be utilized as pre- and post-parent education program measures, with parents as well as…

  9. Outcomes of different bearings in total hip arthroplasty - implant survival, revision causes, and patient-reported outcome.

    PubMed

    Varnum, Claus

    2017-03-01

    Total hip arthroplasty (THA) is a common and successful treatment of patients suffering from severe osteoarthritis that significantly reduces pain and improves hip function and quality of life. Traditionally, the outcome of THA has been evaluated by orthopaedic surgeons and assessed in morbidity and mortality rates, and implant survival. As patients and surgeons may assess outcome after THA differently, patient-reported outcomes (PROMs) have gained much more interest and are today recognized as very important tools for evaluating the outcome and satisfaction after THA. One of the prognostic factors for the outcome of THA is the type of bearings. This PhD thesis focuses on the influence of different types of bearings on implant survival, revision causes, PROMs, and noises from THA. The aims of the thesis were: Study I: To examine the revision risk and to investigate the causes of revision of cementless ceramic-on-ceramic (CoC) THAs comparing them to those of "standard" metal-on-polyethylene (MoP) THAs. Study II: To compare the six-year revision risk for metal-on-metal (MoM) with that for MoP bearings in cementless stemmed THA, and further to study the revision risk for different designs of stemmed MoM THAs and the causes of revision. Study III: To examine the association between CoC, MoM, and MoP bearings and both generic and disease-specific PROMs, and furthermore to examine the incidence and types of noises from the three types of bearings and identify the effect of noises on PROM scores. In study I and III, we used data from the Danish Hip Arthroplasty Registry combined with data from the Civil Registration System and the Danish National Patient Registry. In study II, data from the Nordic Arthroplasty Register Association, containing data from hip arthroplasty registries in Denmark, Norway, Sweden, and Finland, was used. In study I, 11,096 patients operated from 2002 through 2009 with cementless THA were included. Of these, 16% had CoC THA and 84% had MoP THA. At

  10. The heart of the matter: Outcome reporting bias and registration status in cardio-thoracic surgery.

    PubMed

    Wiebe, Jordan; Detten, Grant; Scheckel, Caleb; Gearhart, David; Wheeler, Denna; Sanders, Donald; Vassar, Matt

    2017-01-15

    Our objective is to compare registered outcomes to published reports; to evaluate for discrepancies favoring statistically significant outcomes; to examine funding source and likelihood of outcome reporting bias; and to evaluate for any temporal trends in outcome reporting bias. PubMed was searched for randomized controlled trials published between 2008 and 2015 from 4 high impact cardio-thoracic journals: European Journal of Cardio-thoracic Surgery (EJCS), The Journal of Cardiothoracic Surgery (JCS), The Journal of Thoracic and Cardiovascular Surgery (JTCS), and Annals of Cardiothoracic Surgery (ACS). Data was collected using a standardized extraction form. We reviewed 287 articles, of which 214 (74.6%) did not meet registration criteria. Of those 214, 94 (43.9%) were published in the EJCS, 34 (15.9%) in JCS, 86 (40.2%) in JTCS, and 0 (0%) in the ACS. Of the remaining 73 articles, 34 (46.6%) had a discrepancy between the primary outcome registered and the published outcome, and 11 of the 34 reported p-values favoring the change. We also found that 12 of the 73 registrations had updated primary outcomes from the initial report to the final report. The timing of registration was an incidental finding showing 14 (19.1%) articles retrospectively registered, 29 (39.7%) registered during patient enrollment, and 30 (41.1%) registered prospectively. The results indicated that selective outcome reporting is prevalent in cardio-thoracic surgery journals. The more concerning issue, however, is the lack of registration or provision of registration number for randomized controlled trials within these journals. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  11. Registration status and outcome reporting of trials published in core headache medicine journals.

    PubMed

    Rayhill, Melissa L; Sharon, Roni; Burch, Rebecca; Loder, Elizabeth

    2015-11-17

    To evaluate randomized controlled trial (RCT) registration and outcome reporting compliance in core headache medicine journals. We identified RCTs published in core journals (Headache, Cephalalgia, and the Journal of Headache and Pain) from 2005 through 2014. We searched articles for trial registration numbers, which were verified in the corresponding trial registry. We categorized trial funding sources as industry, academic, government, or mixed. We contacted corresponding authors to assess reasons for nonregistration. We evaluated whether primary outcomes in trial registries matched those in corresponding publications. The journals published 225 RCTs over the study period. Fifty-eight of 225 (26%) reported a trial registration number in the article that could be linked to a corresponding registry entry. Trial registration rates increased over the 9 years of the study. Forty-six of 118 (39%) of industry-funded studies were registered compared with 27% of academic and 0% of government-funded studies. Only 5% of RCTs were prospectively registered, reported primary outcomes identical to those in the trial registry, and did not report unacknowledged post hoc outcomes. The most common reason for nonregistration was lack of awareness. Only about a quarter of the articles published in the core headache medicine journals are compliant with trial registration, but compliance has increased over time. Selective reporting of outcomes remains a problem, and very few trials met all 3 reporting standards assessed in this study. Efforts to improve the quality of trial reporting in the headache literature should continue. © 2015 American Academy of Neurology.

  12. Measuring outcomes of community aged care programs: challenges, opportunities and the Australian Community Outcomes Measurement ACCOM tool.

    PubMed

    Cardona, Beatriz

    2018-05-29

    Measuring health and wellbeing outcomes of community aged care programs is a complex task given the diverse settings in which care takes place and the intersection of numerous factors affecting an individual's quality of life outcomes. Knowledge of a strong causal relationship between services provided and the final outcome enables confidence in assuming the care provided was largely responsible for the outcome achieved (Courtney et al., Aust J Adv Nurs 26:49-57, 2009). The Department of Health has recently reported on the findings of The National Aged Care Quality Indicator Program - Home Care Pilot (KPMG, National Aged Care Quality Indicator Program - Home Care Pilot, 2017). The Program sought to test various tools to measure quality of life outcomes of their community aged care programs. Some of the key issues raised in the study reiterate the findings from The Australian Community Care Outcome Measurement (ACCOM) pilot study (Cardona et al., Australas J Ageing 36: 69-71, 2017), including the value of the ASCOT SCT4 tool (Adult Social care Outcomes Toolkit, http://www.pssru.ac.uk/ascot/downloads/questionnaires/sct4.pdf ) to measure social care related quality of life (SCRQoL) in community aged care programs in the Australian context, the collection of additional data to map the relationship of various variables such as functional ability, demographic characteristics and quality of life scores and the governance and administration of measurement tools for the purpose of quality reporting and consumer choice.

  13. Physical activity questionnaires for youth: a systematic review of measurement properties.

    PubMed

    Chinapaw, Mai J M; Mokkink, Lidwine B; van Poppel, Mireille N M; van Mechelen, Willem; Terwee, Caroline B

    2010-07-01

    Because of the diversity in available questionnaires, it is not easy for researchers to decide which instrument is most suitable for his or her specific demands. Therefore, we systematically summarized and appraised studies examining measurement properties of self-administered and proxy-reported physical activity (PA) questionnaires in youth. Literature was identified through searching electronic databases (PubMed, EMBASE using 'EMBASE only' and SportDiscus) until May 2009. Studies were included if they reported on the measurement properties of self-administered and proxy-reported PA questionnaires in youth (mean age <18 years) and were published in the English language. Methodological quality and results of included studies was appraised using a standardized checklist (qualitative attributes and measurement properties of PA questionnaires [QAPAQ]). We included 54 manuscripts examining 61 versions of questionnaires. None of the included questionnaires showed both acceptable reliability and validity. Only seven questionnaires received a positive rating for reliability. Reported validity varied, with correlations between PA questionnaires and accelerometers ranging from very low to high (previous day PA recall: correlation coefficient [r] = 0.77). In general, PA questionnaires for adolescents correlated better with accelerometer scores than did those for children. From this systematic review, we conclude that no questionnaires were available with both acceptable reliability and validity. Considerably more high-quality research is required to examine the validity and reliability of promising PA questionnaires for youth.

  14. Mission Indicators of Success Outcomes Report, 2000/2001.

    ERIC Educational Resources Information Center

    Pima Community Coll., Tucson, AZ. Office of Institutional Research.

    This report on outcomes of education for Pima Community College (PCC) in Arizona discusses 10 of PCC's success indicators: (1) PCC students and employees will reflect the diversity of the community; (2) students will find the college's programs and services accessible and competitively affordable among Arizona community colleges; (3) college…

  15. Impact of an Automatically Generated Cancer Survivorship Care Plan on Patient-Reported Outcomes in Routine Clinical Practice: Longitudinal Outcomes of a Pragmatic, Cluster Randomized Trial.

    PubMed

    Nicolaije, Kim A H; Ezendam, Nicole P M; Vos, M Caroline; Pijnenborg, Johanna M A; Boll, Dorry; Boss, Erik A; Hermans, Ralph H M; Engelhart, Karin C M; Haartsen, Joke E; Pijlman, Brenda M; van Loon-Baelemans, Ingrid E A M; Mertens, Helena J M M; Nolting, Willem E; van Beek, Johannes J; Roukema, Jan A; Zijlstra, Wobbe P; Kruitwagen, Roy F P M; van de Poll-Franse, Lonneke V

    2015-11-01

    This study was conducted to longitudinally assess the impact of an automatically generated survivorship care plan (SCP) on patient-reported outcomes in routine clinical practice. Primary outcomes were patient satisfaction with information and care. Secondary outcomes included illness perceptions and health care use. Twelve hospitals were randomly assigned to SCP care or usual care in a pragmatic, cluster randomized trial. Newly diagnosed patients with endometrial cancer completed questionnaires after diagnosis (n = 221; 75% response), 6 months (n = 158), and 12 months (n = 147). An SCP application was built in the Web-based ROGY (Registration System Oncological Gynecology). By clicking the SCP button, a patient-tailored SCP was generated. In the SCP care arm, 74% of patients received an SCP. They reported receiving more information about their treatment (mean [M] = 57, standard deviation [SD] = 20 v M = 47, SD = 24; P = .03), other services (M = 35, SD = 22 v M = 25, SD = 22; P = .03), and different places of care (M = 27, SD = 25 v M = 23, SD = 26; P = .04) than the usual care arm (scales, 0 to 100). However, there were no differences regarding satisfaction with information or care. Patients in the SCP care arm experienced more symptoms (M = 3.3, SD = 2.0 v M = 2.6, SD = 1.6; P = .03), were more concerned about their illness (M = 4.4, SD = 2.3 v M = 3.9, SD = 2.1; P = .03), were more affected emotionally (M = 4.0, SD = 2.2 v M = 3.7, SD = 2.2; P = .046), and reported more cancer-related contact with their primary care physician (M = 1.8, SD = 2.0 v M = 1.1, SD = 0.9; P = .003) than those in the usual care arm (scale, 1 to 10). These effects did not differ over time. The present trial showed no evidence of a benefit of SCPs on satisfaction with information and care. Furthermore, SCPs increased patients' concerns, emotional impact, experienced symptoms, and the amount of cancer-related contact with the primary care physician. Whether this may ultimately lead to more

  16. Patient-Reported Outcomes of Periacetabular Osteotomy from the Prospective ANCHOR Cohort Study

    PubMed Central

    Clohisy, John C.; Ackerman, Jeffrey; Baca, Geneva; Baty, Jack; Beaulé, Paul E.; Kim, Young-Jo; Millis, Michael B.; Podeszwa, David A.; Schoenecker, Perry L.; Sierra, Rafael J.; Sink, Ernest L.; Sucato, Daniel J.; Trousdale, Robert T.; Zaltz, Ira

    2017-01-01

    Background: Current literature describing the periacetabular osteotomy (PAO) is mostly limited to retrospective case series. Larger, prospective cohort studies are needed to provide better clinical evidence regarding this procedure. The goals of the current study were to (1) report minimum 2-year patient-reported outcomes (pain, hip function, activity, overall health, and quality of life), (2) investigate preoperative clinical and disease characteristics as predictors of clinical outcomes, and (3) report the rate of early failures and reoperations in patients undergoing contemporary PAO surgery. Methods: A large, prospective, multicenter cohort of PAO procedures was established, and outcomes at a minimum of 2 years were analyzed. A total of 391 hips were included for analysis (79% of the patients were female, and the average patient age was 25.4 years). Patient-reported outcomes, conversion to total hip replacement, reoperations, and major complications were documented. Variables with a p value of ≤0.10 in the univariate linear regressions were included in the multivariate linear regression. The backward stepwise selection method was used to determine the final risk factors of clinical outcomes. Results: Clinical outcome analysis demonstrated major clinically important improvements in pain, function, quality of life, overall health, and activity level. Increasing age and a body mass index status of overweight or obese were predictive of improved results for certain outcome metrics. Male sex and mild acetabular dysplasia were predictive of lesser improvements in certain outcome measures. Three (0.8%) of the hips underwent early conversion to total hip arthroplasty, 12 (3%) required reoperation, and 26 (7%) experienced a major complication. Conclusions: This large, prospective cohort study demonstrated the clinical success of contemporary PAO surgery for the treatment of symptomatic acetabular dysplasia. Patient and disease characteristics demonstrated predictive

  17. Psychometric Characteristics of the Modified World Affairs Questionnaire.

    ERIC Educational Resources Information Center

    Mayton, Daniel M., II

    1988-01-01

    Subjected Modified World Affairs Questionnaire (MWAQ) to comparable common factor analysis which identified five factors: civil defense, escalation, nuclear war outcome, probability/worry, and patriotic. Alpha coefficients and test-retest reliability were determined to be adequate for the first four subscales. Acceptable discriminant validity and…

  18. PATIENT-REPORTED OUTCOMES (PROs): PUTTING THE PATIENT PERSPECTIVE IN PATIENT-CENTERED OUTCOMES RESEARCH

    PubMed Central

    Snyder, Claire F.; Jensen, Roxanne E.; Segal, Jodi B.; Wu, Albert W.

    2013-01-01

    Patient-centered outcomes research (PCOR) aims to improve care quality and patient outcomes by providing information that patients, clinicians, and family members need regarding treatment alternatives, and emphasizing patient input to inform the research process. PCOR capitalizes on available data sources and generates new evidence to provide timely and relevant information and can be conducted using prospective data collection, disease registries, electronic medical records, aggregated results from prior research, and administrative claims. Given PCOR’s emphasis on the patient perspective, methods to incorporate patient-reported outcomes (PROs) are critical. PROs are defined by the U.S. Food & Drug Administration as “Any report coming directly from patients… about a health condition and its treatment.” However, PROs have not routinely been collected in a way that facilitates their use in PCOR. Electronic medical records, disease registries, and administrative data have only rarely collected, or been linked to, PROs. Recent technological developments facilitate the electronic collection of PROs and linkage of PRO data, offering new opportunities for putting the patient perspective in PCOR. This paper describes the importance of and methods for using PROs for PCOR. We (1) define PROs; (2) identify how PROs can be used in PCOR, and the critical role of electronic data methods for facilitating the use of PRO data in PCOR; (3) outline the challenges and key unanswered questions that need to be addressed for the routine use of PROs in PCOR; and (4) discuss policy and research interventions to accelerate the integration of PROs with clinical data. PMID:23774513

  19. Outcome switching in randomized controlled oncology trials reporting on surrogate endpoints: a cross-sectional analysis.

    PubMed

    Falk Delgado, Alberto; Falk Delgado, Anna

    2017-08-23

    Inconsistent reporting of clinical trials is well-known in the literature. Despite this, factors associated with poor practice such as outcome switching in clinical trials are poorly understood. We performed a cross-sectional analysis to evaluate the prevalence of, and the factors associated with outcome switching. PubMed and Embase were searched for pharmaceutical randomized controlled trials (RCTs) in oncology reporting on a surrogate primary outcome published in 2015. Outcome switching was present in 18% (39/216). First-author male sex was significantly more likely associated with outcome switching compared to female sex with an OR of 3.05 (95% CI 1.07-8.64, p = 0.04) after multivariable adjustment. For-profit funded RCTs were less likely associated with outcome switching compared to non-profit funded research with an OR of 0.22 (95% CI 0.07-0.74, p = 0.01). First author male sex was more likely associated with outcome switching compared to female sex in drug oncology RCTs reporting on a primary surrogate endpoint. For-profit funded research was less likely associated with outcome switching compared to research funded by non-profit organizations. Furthermore, 18 percent of drug oncology trials reporting on a surrogate endpoint could have a higher risk of false positive results due to primary outcome switching.

  20. Transverse pinning versus intramedullary pinning in fifth metacarpal's neck fractures: A randomized controlled study with patient-reported outcome.

    PubMed

    Galal, Sherif; Safwat, Wael

    2017-01-01

    The 5th metacarpal fractures accounts for 38% of all hand fractures given that the neck is the weakest point in metacarpals, so neck fracture is the most common metacarpal fracture. Surgical fixation is also advocated for such fractures to prevent mal-rotation of the little finger which will lead to fingers overlap in a clenched fist. Various methods are available for fixation of such fractures, like intramedullary & transverse pinning. There are very few reports in the literature comparing both techniques. Authors wanted to compare outcomes and complications of transverse pinning versus intramedullary pinning in fifth metacarpal's neck fractures. A single-center, parallel group, prospective, randomized study was conducted at an academic Level 1 Trauma Center from October 2014 to December 2016. A total of 80 patients with 5th metacarpal's neck fractures were randomized to pinning using either transverse pinning (group A) or intramedullary pinning (group B). Patients were assessed clinically on range of motion, patient-reported outcome using the Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire & radiographically. Two blinded observers assessed outcomes. At final follow up for each patient (12 months) the statistically significant differences were observed in operative time, the transverse pinning group showed shorter operative time, as well as complication rate as complications were observed only in intramedullary pinning group. No differences were found in range of motion or the Quick -DASH score. Both techniques are equally safe and effective treatment option for 5th metacarpal's neck fractures. The only difference was shorter operative time & less incidence of complications in transverse pinning group. Level II, Therapeutic study.

  1. The MPC&A Questionnaire

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Powell, Danny H; Elwood Jr, Robert H

    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) systemmore » 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.« less

  2. Psychometric data of a questionnaire to measure cyberbullying bystander behavior and its behavioral determinants among adolescents.

    PubMed

    DeSmet, A; Bastiaensens, S; Van Cleemput, K; Poels, K; Vandebosch, H; Deboutte, G; Herrewijn, L; Malliet, S; Pabian, S; Van Broeckhoven, F; De Troyer, O; Deglorie, G; Van Hoecke, S; Samyn, K; De Bourdeaudhuij, I

    2018-06-01

    .This paper describes the items, scale validity and scale reliability of a self-report questionnaire that measures bystander behavior in cyberbullying incidents among adolescents, and its behavioral determinants. Determinants included behavioral intention, behavioral attitudes, moral disengagement attitudes, outcome expectations, self-efficacy, subjective norm and social skills. Questions also assessed (cyber-)bullying involvement. Validity and reliability information is based on a sample of 238 adolescents (M age=13.52 years, SD=0.57). Construct validity was assessed using Confirmatory Factor Analysis (CFA) or Exploratory Factor Analysis (EFA) in Mplus7 software. Reliability (Cronbach Alpha, α) was assessed in SPSS, version 22. Data and questionnaire are included in this article. Further information can be found in DeSmet et al. (2018) [1].

  3. Usefulness of the rivermead postconcussion symptoms questionnaire and the trail-making test for outcome prediction in patients with mild traumatic brain injury.

    PubMed

    de Guise, Elaine; Bélanger, Sara; Tinawi, Simon; Anderson, Kirsten; LeBlanc, Joanne; Lamoureux, Julie; Audrit, Hélène; Feyz, Mitra

    2016-01-01

    The aim of the study was to determine if the Rivermead Postconcussion Symptoms Questionnaire (RPQ) is a better tool for outcome prediction than an objective neuropsychological assessment following mild traumatic brain injury (mTBI). The study included 47 patients with mTBI referred to an outpatient rehabilitation clinic. The RPQ and a brief neuropsychological battery were performed in the first few days following the trauma. The outcome measure used was the Mayo-Portland Adaptability Inventory-4 (MPAI-4) which was completed within the first 3 months. The only variable associated with results on the MPAI-4 was the RPQ score (p < .001). The predictive outcome model including age, education, and the results of the Trail-Making Test-Parts A and B (TMT) had a pseudo-R(2) of .02. When the RPQ score was added, the pseudo-R(2) climbed to .19. This model indicates that the usefulness of the RPQ score and the TMT in predicting moderate-to-severe limitations, while controlling for confounders, is substantial as suggested by a significant increase in the model chi-square value, delta (1df) = 6.517, p < .001. The RPQ and the TMT provide clinicians with a brief and reliable tool for predicting outcome functioning and can help target the need for further intervention and rehabilitation following mTBI.

  4. Measuring Patient-Reported Outcomes: Key Metrics in Reconstructive Surgery.

    PubMed

    Voineskos, Sophocles H; Nelson, Jonas A; Klassen, Anne F; Pusic, Andrea L

    2018-01-29

    Satisfaction and improved quality of life are among the most important outcomes for patients undergoing plastic and reconstructive surgery for a variety of diseases and conditions. Patient-reported outcome measures (PROMs) are essential tools for evaluating the benefits of newly developed surgical techniques. Modern PROMs are being developed with new psychometric approaches, such as Rasch Measurement Theory, and their measurement properties (validity, reliability, responsiveness) are rigorously tested. These advances have resulted in the availability of PROMs that provide clinically meaningful data and effectively measure functional as well as psychosocial outcomes. This article guides the reader through the steps of creating a PROM and highlights the potential research and clinical uses of such instruments. Limitations of PROMs and anticipated future directions in this field are discussed.

  5. Moving toward a standard for spinal fusion outcomes assessment.

    PubMed

    Blount, Kevin J; Krompinger, W Jay; Maljanian, Rose; Browner, Bruce D

    2002-02-01

    Previous spinal fusion outcomes assessment studies have been complicated by inconsistencies in evaluative criteria and consequent variations in results. As a result, a general consensus is lacking on how to achieve comprehensive outcomes assessment for spinal fusion surgeries. The purpose of this article is to report the most validated and frequently used assessment measures to facilitate comparable outcomes studies in the future. Twenty-seven spinal fusion outcomes studies published between 1990 and 2000 were retrospectively reviewed. Study characteristics such as design, evaluative measures, and assessment tools were recorded and analyzed. Based on the reviewed literature, an outcomes assessment model is proposed including the Short Form-36 Health Survey, the Oswestry Disability Questionnaire, the North American Spine Society Patient Satisfaction Index, the Prolo Economic Scale, a 0-10 analog pain scale, medication use, radiographically assessed fusion status, and a generalized complication rate.

  6. [Long-term outcomes after hypospadias surgery: Sexual reported outcomes and quality of life in adulthood].

    PubMed

    Even, L; Bouali, O; Moscovici, J; Huyghe, E; Pienkowski, C; Rischmann, P; Galinier, P; Game, X

    2015-09-01

    To evaluate outcomes and long-term sexual quality of life after hypospadias surgery. Seventeen-years-old patients operated for a posterior hypospadias in childhood were included in a transversal study. Fifteen patients, among the forty children treated since 1997, accepted to participate. These young men (mean age at the first surgery was 27.9±20months) were clinically reviewed and responded to questionnaires (EUROQOL 5, IIEF15 and non-validated questionnaire). This study arises about 8.4±5years after the last visit in paediatric department. Mean study age was 21.2±4.7years. One third of patients thought that global quality of life was distorted. Although 33% of the patients had erectile dysfunction, 80% were satisfied with their sexual quality of life. The most important complains were relative to the penile appearance. Number of procedures was not predictive of patient's satisfaction about penile function and appearance. Thirty-three percents of the patients would have been satisfied to have psychological and medical support. They would be interested in having contact with patients who suffered from the same congenital abnormality. These patients had functional and esthetical disturbances. This visit leads to a specific visit in 20% cases. In this study, medical follow-up does not seem to be counselling and had to be adapted. Adequate follow-up transition between paediatric and adult departments especially during adolescence seems to be necessary. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  7. Adherence and health literacy as related to outcome of patients treated for rheumatoid arthritis : Analyses of a large-scale observational study.

    PubMed

    Kuipers, J G; Koller, M; Zeman, F; Müller, K; Rüffer, J U

    2018-04-24

    Disabilities in daily living and quality of life are key endpoints for evaluating the treatment outcome for rheumatoid arthritis (RA). Factors possibly contributing to good outcome are adherence and health literacy. The survey included a representative nationwide sample of German rheumatologists and their patients with RA. The physician questionnaire included the disease activity score (DAS28) and medical prescriptions. The patient questionnaire included fatigue (EORTC QLQ-FA13), health assessment questionnaire (HAQ), quality of life (SF-12), health literacy (HELP), and patients' listings of their medications. Adherence was operationalized as follows: patient-reported (CQR5), behavioral (concordance between physicians' and patients' listings of medications), physician-assessed, and a combined measure of physician rating (1 = very adherent, 0 = less adherent) and the match between physicians' prescriptions and patients' accounts of their medications (1 = perfect match, 0 = no perfect match) that yielded three categories of adherence: high, medium, and low. Simple and multiple linear regressions (controlling for age, sex, smoking, drinking alcohol, and sport) were calculated using adherence and health literacy as predictor variables, and disease activity and patient-reported outcomes as dependent variables. 708 pairs of patient and physician questionnaires were analyzed. The mean patient age (73% women) was 60 years (SD = 12). Multiple regression analyses showed that high adherence was significantly associated with 5/7 outcome variables and health literacy with 7/7 outcome variables. Adherence and health literacy had weak but consistent effects on most outcomes. Thus, enhancing adherence and understanding of medical information could improve outcome, which should be investigated in future interventional studies.

  8. Concurrent Validity of a Self-Reported Physical Activity “Vital Sign” Questionnaire With Adult Primary Care Patients

    PubMed Central

    Joy, Elizabeth A.; Gren, Lisa H.; Shaw, Janet M.

    2016-01-01

    Introduction No tool currently used by primary health care providers to assess physical activity has been evaluated for its ability to determine whether or not patients achieve recommended levels of activity. The purpose of this study was to assess concurrent validity of physical activity self-reported to the brief (<30 sec) Physical Activity “Vital Sign” questionnaire (PAVS) compared with responses to the lengthier (3–5 min), validated Modifiable Activity Questionnaire (MAQ). Methods Agreement between activity reported to the PAVS and MAQ by primary care patients at 2 clinics in 2014 was assessed by using percentages and κ coefficients. Agreement consisted of meeting or not meeting the 2008 Aerobic Physical Activity Guidelines for Americans (PA Guidelines) of the US Department of Health and Human Services. We compared self-reported usual minutes per week of moderate-to-vigorous physical activity among patients at a primary care clinic in 2014 who reported to PAVS and to MAQ by using Pearson correlation and Bland–Altman plots of agreement. Results Among 269 consenting patients who reported physical activity, PAVS results agreed with those of MAQ 89.6% of the time and demonstrated good agreement in identifying patients who did not meet PA Guidelines recommendations (κ = 0.55, ρ = 0.57; P < .001). Usual minutes per week of moderate-to-vigorous physical activity reported to PAVS had a high positive correlation with the same reported to MAQ (r = 0.71; P < .001). Conclusion PAVS may be a valid tool for identifying primary care patients who need counseling about physical activity. PAVS should be assessed further for agreement with repeated objective measures of physical activity in the patient population. PMID:26851335

  9. Reliability of questionnaires to assess the healthy eating and activity environment of a child's home and school.

    PubMed

    Wilson, Annabelle; Magarey, Anthea; Mastersson, Nadia

    2013-01-01

    Childhood overweight and obesity are a growing concern globally, and environments, including the home and school, can contribute to this epidemic. This paper assesses the reliability of two questionnaires (parent and teacher) used in the evaluation of a community-based childhood obesity prevention intervention, the eat well be active (ewba) Community Programs. Parents and teachers were recruited from two primary schools and they completed the same questionnaire twice in 2008 and 2009. Data from both questionnaires were classified into outcomes relevant to healthy eating and activity, and target outcomes, based on the goals of the ewba Community Programs, were identified. Fourteen and 12 outcomes were developed from the parent and teacher questionnaires, respectively. Sixty parents and 28 teachers participated in the reliability study. Intraclass correlation coefficients for outcomes ranged from 0.37 to 0.92 (parent) (P < 0.05) and from 0.42 to 0.86 (teacher) (P < 0.05). Internal consistency, measured by Cronbach's alpha, of teacher scores ranged from 0.11 to 0.91 and 0.13 to 0.78 for scores from the parent questionnaire. The parent and teacher questionnaires are moderately reliable tools for simultaneously assessing child intakes, environments, attitudes, and knowledge associated with healthy eating and physical activity in the home and school and may be useful for evaluation of similar programs.

  10. A longitudinal analysis of nursing home outcomes.

    PubMed

    Porell, F; Caro, F G; Silva, A; Monane, M

    1998-10-01

    To investigate resident and facility attributes associated with long-term care health outcomes in nursing homes. Quarterly Management Minutes Questionnaire (MMQ) survey data for Medicaid case-mix reimbursement of nursing homes in Massachusetts from 1991 to 1994, for specification of outcomes and resident attributes. Facility attributes are specified from cost report data. Multivariate logistic and "state-dependence" regression models are estimated for survival, ADL functional status, incontinence status, and mental status outcomes from longitudinal residence histories of Medicaid residents spanning 3 to 36 months in length. Outcomes are specified to be a function of resident demographic and diagnostic attributes and facility-level operating and nurse staffing attributes. The estimated parameters for resident demographic and diagnostic attributes showed a great deal of construct validity with respect to clinical expectations regarding risk factors for adverse outcomes. Few facility attributes were associated with outcomes generally, and none was significantly associated with all four outcomes. The absence of uniform associations between facility attributes and the various long-term care health outcomes studied suggests that strong facility performance on one health outcome may coexist with much weaker performance on other outcomes. This has implications for the aggregation of individual facility performance measures on multiple outcomes and the development of overall outcome performance measures.

  11. Which Questionnaire Should Be Used to Measure Quality-of-Life Utilities in Patients with Acute Leukemia? An Evaluation of the Validity and Interpretability of the EQ-5D-5L and Preference-Based Questionnaires Derived from the EORTC QLQ-C30.

    PubMed

    van Dongen-Leunis, Annemieke; Redekop, W Ken; Uyl-de Groot, Carin A

    The aim of this study was to assess the validity and interpretability of different preference-based questionnaires (generic 5-level EuroQol five-dimensional questionnaire [EQ-5D-5L], cancer-specific Quality of Life Questionnaire Preference-Based Measure, and European Organization of Randomized Controlled Trials 8 Dimension [EORTC-8D]) in patients with acute leukemia. Patients who participated in Hemato-Oncologie voor Volwassenen Nederland (HOVON - the Haemato Oncology Foundation for Adults in the Netherlands) clinical trials between 1999 and 2011 at a single hospital were invited to complete the questionnaires. Interpretability was evaluated by the frequency of incomplete data and highest and lowest possible scores. Content validity was evaluated by exploring the health-related quality-of-life domains included in the questionnaires. Construct validity was assessed using correlations with other quality-of-life scales (EQ-visual analogue scale score and global quality-of-life scale of the EORTC Quality of Life Questionnaire) and ability to distinguish between patients with different health statuses. Questionnaires were returned by 89% (111 of 125) of the patients. Six to seven respondents did not return full questionnaires. Perfect health on the EQ-5D-5L was reported by 32 respondents and many of them (N = 17) did report health problems on other questionnaires. All questionnaires were strongly correlated (range 0.61-0.78) with other quality-of-life scales and yielded substantially different utility values for patients with different health statuses. Nevertheless, the disease-specific preference-based questionnaires showed greater discriminatory power. Although the Quality of Life Questionnaire Preference-Based Measure and the EORTC-8D appear to have better validity, this study does not provide any strong evidence against the use of the EQ-5D-5L for measuring quality-of-life utilities in acute leukemia. However, our findings need to be confirmed in larger longitudinal

  12. Validation of the Spine Oncology Study Group-Outcomes Questionnaire to assess quality of life in patients with metastatic spine disease.

    PubMed

    Janssen, Stein J; Teunis, Teun; van Dijk, Eva; Ferrone, Marco L; Shin, John H; Hornicek, Francis; Schwab, Joseph H

    2017-06-01

    General questionnaires are often used to assess quality of life in patients with spine metastases, although a disease-specific survey did not exist until recently. The Spine Oncology Study Group has developed an outcomes questionnaire (SOSG-OQ) to measure quality of life in these patients. However, a scoring system was not developed, and the questionnaire was not validated in a group of patients, nor was it compared with other general quality of life questionnaires such as the EuroQol 5 Dimensions (EQ-5D) questionnaire. Our primary null hypothesis is that there is no association between the SOSG-OQ and EQ-5D. Our secondary null hypothesis is that there is no difference in coverage and internal consistency between the SOSG-OQ and EQ-5D. We also assess coverage, consistency, and validity of the domains within the SOSG-OQ. A survey study from a tertiary care spine referral center was used for this study. The patient sample consisted of 82 patients with spine metastases, myeloma, or lymphoma. The SOSG-OQ (27 questions, 6 domains) score ranges from 0 to 80, with a higher score indicating worse quality of life. The EQ-5D (5 questions, 5 domains) index score ranges from 0 to 1, with a higher score indicating better quality of life. The association between the SOSG-OQ and EQ-5D index score was assessed using the Spearman rank correlation. Instrument coverage and precision were assessed by determining item completion rate, median score with range, and floor and ceiling effect. Internal consistency was assessed using Cronbach alpha. Multitrait analysis and exploratory factor analysis were used to analyze properties of the individual domains in the SOSG-OQ. The Spearman rank correlation between the SOSG-OQ and EQ-5D questionnaire was high (r=-0.83, p<.001). Internal consistency of the SOSG-OQ (0.92, 95% CI: 0.89-0.94) was higher as compared to the internal consistency of the EQ-5D (0.73, 95% CI: 0.63-0.84; p<.001). The SOSG-OQ score had no floor or ceiling effect indicating

  13. Can UK NHS research ethics committees effectively monitor publication and outcome reporting bias?

    PubMed

    Begum, Rasheda; Kolstoe, Simon

    2015-07-25

    Publication and outcome reporting bias is often caused by researchers selectively choosing which scientific results and outcomes to publish. This behaviour is ethically significant as it distorts the literature used for future scientific or clinical decision-making. This study investigates the practicalities of using ethics applications submitted to a UK National Health Service (NHS) research ethics committee to monitor both types of reporting bias. As part of an internal audit we accessed research ethics database records for studies submitting an end of study declaration to the Hampshire A research ethics committee (formerly Southampton A) between 1st January 2010 and 31st December 2011. A literature search was used to establish the publication status of studies. Primary and secondary outcomes stated in application forms were compared with outcomes reported in publications. Out of 116 studies the literature search identified 57 publications for 37 studies giving a publication rate of 32%. Original Research Ethics Committee (REC) applications could be obtained for 28 of the published studies. Outcome inconsistencies were found in 16 (57%) of the published studies. This study showed that the problem of publication and outcome reporting bias is still significant in the UK. The method described here demonstrates that UK NHS research ethics committees are in a good position to detect such bias due to their unique access to original research protocols. Data gathered in this way could be used by the Health Research Authority to encourage higher levels of transparency in UK research.

  14. Use of the WOMAC questionnaire in Mumbai and the challenges of translation and cross cultural adaptation.

    PubMed

    Gogtay, N J; Thatte, U M; Dasgupta, B; Deshpande, S

    2013-01-01

    Patient-reported outcome measures (PROMs) are disease specific questionnaires that are being increasingly used in clinical practice and research. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), is a widely used PROM in patients with hip or knee osteoarthritis. A validated WOMAC was used by us, and significant challenges were faced in administering it as several questions did not have a cultural connect. Functionally equivalent items in the Indian context had then to be used to complete the score. With greater emphasis today on the use of patient-reported outcome measures, and with data from multi-centric studies being pooled, cross-cultural adaptation becomes very important if the pooled data are to be really relevant. In India, with several languages being spoken, and a significant proportion of the population being illiterate, the physician and/ or the impartial witness must provide considerable explanation without attempting to influence the response. The key to the effective and correct use of PROMs thus lies not just in translation, but also in a stepwise validation of the questionnaire, and modification in the context of the country where it is used. Scores like WOMAC are often primary efficacy endpoints in clinical trials; are gaining greater importance to support label claims; have ethical implications, and directly impact regulatory decision making and thus, eventually, evidence-based practice.

  15. Optimal functional outcome measures for assessing treatment for Dupuytren’s disease: a systematic review and recommendations for future practice

    PubMed Central

    2013-01-01

    Background Dupuytren's disease of the hand is a common condition affecting the palmar fascia, resulting in progressive flexion deformities of the digits and hence limitation of hand function. The optimal treatment remains unclear as outcomes studies have used a variety of measures for assessment. Methods A literature search was performed for all publications describing surgical treatment, percutaneous needle aponeurotomy or collagenase injection for primary or recurrent Dupuytren’s disease where outcomes had been monitored using functional measures. Results Ninety-one studies met the inclusion criteria. Twenty-two studies reported outcomes using patient reported outcome measures (PROMs) ranging from validated questionnaires to self-reported measures for return to work and self-rated disability. The Disability of Arm, Shoulder and Hand (DASH) score was the most utilised patient-reported function measure (n=11). Patient satisfaction was reported by eighteen studies but no single method was used consistently. Range of movement was the most frequent physical measure and was reported in all 91 studies. However, the methods of measurement and reporting varied, with seventeen different techniques being used. Other physical measures included grip and pinch strength and sensibility, again with variations in measurement protocols. The mean follow-up time ranged from 2 weeks to 17 years. Conclusions There is little consistency in the reporting of outcomes for interventions in patients with Dupuytren’s disease, making it impossible to compare the efficacy of different treatment modalities. Although there are limitations to the existing generic patient reported outcomes measures, a combination of these together with a disease-specific questionnaire, and physical measures of active and passive individual joint Range of movement (ROM), grip and sensibility using standardised protocols should be used for future outcomes studies. As Dupuytren’s disease tends to recur

  16. Clinical assessment and patient-reported outcome measures in low-back pain - a survey among primary health care physiotherapists.

    PubMed

    Östhols, Sara; Boström, Carina; Rasmussen-Barr, Eva

    2018-05-09

    We aimed to map the physiotherapy practice in Sweden of clinical tests and patient-reported outcome measures in low-back pain (LBP), and to study advantages and barriers in using patient-reported outcome measures. An online survey was mailed to 4934 physiotherapists in primary health care in Sweden. Multiple choice questions investigated the use of clinical tests and patient-reported outcome measures in assessing patients with LBP. Open questions investigating the advantages and barriers to the use of patient-reported outcome measures were analyzed with content analysis. The response rate was 25% (n = 1217). Clinical tests were used "always/often" by >60% of the participants, while most patient-reported outcome measures were used by <15%. Advantages in using patient-reported outcome measures were: the clinical reasoning process, to increase the quality of assessment, to get the patient's voice, education and motivation of patients, and communication with health professionals. Barriers were lack of time and knowledge, administrative aspects, the interaction between physiotherapist and patient and, the applicability and validity of the patient-reported outcome measures. Our findings show that physiotherapists working in primary health care use clinical testing in LBP to a great extent, while various patient-reported outcome measures are used to a low-to-very-low extent. Several barriers to the use of patient-reported outcome measures were reported such as time, knowledge, and administrative issues, while important findings on advantages were to enhance the clinical reasoning process and to educate and motivate the patient. Barriers might be changed through education or organizational change-work. To enhance the use of patient-reported outcome measures and thus person-centered care in low-back pain, recommendation, and education on various patient-reported outcome measures need to be advocated. Implications for rehabilitation To increase the effects of

  17. Validation of the Oxford Participation and Activities Questionnaire.

    PubMed

    Morley, David; Dummett, Sarah; Kelly, Laura; Dawson, Jill; Fitzpatrick, Ray; Jenkinson, Crispin

    2016-01-01

    There is growing interest in the management of long-term conditions and in keeping people active and participating in the community. Testing the effectiveness of interventions that aim to affect activities and participation can be challenging without a well-developed, valid, and reliable instrument. This study therefore aims to develop a patient-reported outcome measure, the Oxford Participation and Activities Questionnaire (Ox-PAQ), which is theoretically grounded in the World Health Organization's International Classification of Functioning, Disability, and Health (ICF) and fully compliant with current best practice guidelines. Questionnaire items generated from patient interviews and based on the nine chapters of the ICF were administered by postal survey to 386 people with three neurological conditions: motor neuron disease, multiple sclerosis, and Parkinson's disease. Participants also completed the Medical Outcomes Study (MOS) 36-Item Short Form Health Survey (SF-36) and EQ-5D-5L. Thus, 334 participants completed the survey, a response rate of 86.5%. Factor analysis techniques identified three Ox-PAQ domains, consisting of 23 items, accounting for 72.8% of variance. Internal reliability for the three domains was high (Cronbach's α: 0.81-0.96), as was test-retest reliability (intraclass correlation: 0.83-0.92). Concurrent validity was demonstrated through highly significant relationships with relevant domains of the MOS SF-36 and the EQ- 5D-5L. Assessment of known-groups validity identified significant differences in Ox-PAQ scores among the three conditions included in the survey. Results suggest that the Ox-PAQ is a valid and reliable measure of participation and activity. The measure will now be validated in a range of further conditions, and additional properties, such as responsiveness, will also be assessed in the next phase of the instrument's development.

  18. Validation of the Oxford Participation and Activities Questionnaire

    PubMed Central

    Morley, David; Dummett, Sarah; Kelly, Laura; Dawson, Jill; Fitzpatrick, Ray; Jenkinson, Crispin

    2016-01-01

    Purpose There is growing interest in the management of long-term conditions and in keeping people active and participating in the community. Testing the effectiveness of interventions that aim to affect activities and participation can be challenging without a well-developed, valid, and reliable instrument. This study therefore aims to develop a patient-reported outcome measure, the Oxford Participation and Activities Questionnaire (Ox-PAQ), which is theoretically grounded in the World Health Organization’s International Classification of Functioning, Disability, and Health (ICF) and fully compliant with current best practice guidelines. Methods Questionnaire items generated from patient interviews and based on the nine chapters of the ICF were administered by postal survey to 386 people with three neurological conditions: motor neuron disease, multiple sclerosis, and Parkinson’s disease. Participants also completed the Medical Outcomes Study (MOS) 36-Item Short Form Health Survey (SF-36) and EQ-5D-5L. Results Thus, 334 participants completed the survey, a response rate of 86.5%. Factor analysis techniques identified three Ox-PAQ domains, consisting of 23 items, accounting for 72.8% of variance. Internal reliability for the three domains was high (Cronbach’s α: 0.81–0.96), as was test–retest reliability (intraclass correlation: 0.83–0.92). Concurrent validity was demonstrated through highly significant relationships with relevant domains of the MOS SF-36 and the EQ- 5D-5L. Assessment of known-groups validity identified significant differences in Ox-PAQ scores among the three conditions included in the survey. Conclusion Results suggest that the Ox-PAQ is a valid and reliable measure of participation and activity. The measure will now be validated in a range of further conditions, and additional properties, such as responsiveness, will also be assessed in the next phase of the instrument’s development. PMID:27366108

  19. Principles and methodology for translation and cross-cultural adaptation of the Nordic Occupational Skin Questionnaire (NOSQ-2002) to Spanish and Catalan.

    PubMed

    Sala-Sastre, Nohemi; Herdman, Mike; Navarro, Lidia; de la Prada, Miriam; Pujol, Ramón M; Serra, Consol; Alonso, Jordi; Flyvholm, Mari-Ann; Giménez-Arnau, Ana M

    2009-08-01

    Occupational skin diseases are among the most frequent work-related diseases in industrialized countries. The Nordic Occupational Skin Questionnaire (NOSQ-2002), developed in English, is a useful tool for screening of occupational skin diseases. To culturally adapt the NOSQ-2002 to Spanish and Catalan and to assess the clarity, comprehension, cultural relevance and appropriateness of the translated versions. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) principles of good practice for the translation and cultural adaptation of patient-reported outcomes were followed. After translation into the target language, a first consensus version of the questionnaire was evaluated in multiple cognitive debriefing interviews. The expert panel introduced some modifications in 39 (68%) and 27 (47%) items in the Spanish and Catalan version, respectively (e.g. addition of examples and definitions, reformulation of instructions and use of direct question format). This version was back translated and submitted to the original authors, who suggested a further seven and two modifications in the Spanish and Catalan versions, respectively. A second set of cognitive interviews were performed. A consensus version of both questionnaires was obtained after final modifications based on comments by the patients. The final versions of the Spanish and Catalan NOSQ-2002 questionnaires are now available at www.NRCWE.dk/NOSQ.

  20. Recommendation for measuring clinical outcome in distal radius fractures: a core set of domains for standardized reporting in clinical practice and research.

    PubMed

    Goldhahn, Jörg; Beaton, Dorcas; Ladd, Amy; Macdermid, Joy; Hoang-Kim, Amy

    2014-02-01

    Lack of standardization of outcome measurement has hampered an evidence-based approach to clinical practice and research. We adopted a process of reviewing evidence on current use of measures and appropriate theoretical frameworks for health and disability to inform a consensus process that was focused on deriving the minimal set of core domains in distal radius fracture. We agreed on the following seven core recommendations: (1) pain and function were regarded as the primary domains, (2) very brief measures were needed for routine administration in clinical practice, (3) these brief measures could be augmented by additional measures that provide more detail or address additional domains for clinical research, (4) measurement of pain should include measures of both intensity and frequency as core attributes, (5) a numeric pain scale, e.g. visual analogue scale or visual numeric scale or the pain subscale of the patient-reported wrist evaluation (PRWE) questionnaires were identified as reliable, valid and feasible measures to measure these concepts, (6) for function, either the Quick Disability of the arm, shoulder and hand questionnaire or PRWE-function subscale was identified as reliable, valid and feasible measures, and (7) a measure of participation and treatment complications should be considered core outcomes for both clinical practice and research. We used a sound methodological approach to form a comprehensive foundation of content for outcomes in the area of distal radius fractures. We recommend the use of symptom and function as separate domains in the ICF core set in clinical research or practice for patients with wrist fracture. Further research is needed to provide more definitive measurement properties of measures across all domains.

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

    PubMed Central

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

    2011-01-01

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

  2. Can standardized sleep questionnaires be used to identify excessive daytime sleeping in older post-acute rehabilitation patients?

    PubMed

    Skibitsky, Megan; Edelen, Maria Orlando; Martin, Jennifer L; Harker, Judith; Alessi, Cathy; Saliba, Debra

    2012-02-01

    Excessive daytime sleeping is associated with poorer functional outcomes in rehabilitation populations and may be improved with targeted interventions. The purpose of this study was to test simple methods of screening for excessive daytime sleeping among older adults admitted for postacute rehabilitation. Secondary analysis of data from 2 clinical samples. Two postacute rehabilitation (PAR) units in southern California. Two hundred twenty-six patients older than 65 years with Mini-Mental State Examination (MMSE) score higher than 11 undergoing rehabilitation. The primary outcome was excessive daytime sleeping, defined as greater than 15% (1.8 hours) of daytime hours (8 am to 8 pm) sleeping as measured by actigraphy. Participants spent, on average, 16.2% (SD 12.5%) of daytime hours sleeping as measured by actigraphy. Thirty-nine percent of participants had excessive daytime sleeping. The Pittsburgh Sleep Quality Index (PSQI) was significantly associated with actigraphically measured daytime sleeping (P = .0038), but the Epworth Sleepiness Scale (ESS) was not (P = .49). Neither the ESS nor the PSQI achieved sufficient sensitivity and specificity to be used as a screening tool for excessive daytime sleeping. Two additional models using items from these questionnaires were not significantly associated with the outcome. In an older PAR population, self-report items from existing sleep questionnaires do not identify excessive daytime sleeping. Therefore we recommend objective measures for the evaluation of excessive daytime sleeping as well as further research to identify new self-report items that may be more applicable in PAR populations. Copyright © 2012 American Medical Directors Association, Inc. Published by Elsevier Inc. All rights reserved.

  3. Information perception, wishes, and satisfaction in ambulatory cancer patients under active treatment: patient-reported outcomes with QLQ-INFO25

    PubMed Central

    Pinto, Ana Catarina; Ferreira-Santos, Fernando; Lago, Lissandra Dal; de Azambuja, Evandro; Pimentel, Francisco Luís; Piccart-Gebhart, Martine; Razavi, Darius

    2014-01-01

    Background Information is vital to cancer patients. Physician–patient communication in oncology presents specific challenges. The aim of this study was to evaluate self-reported information of cancer patients in ambulatory care at a comprehensive cancer centre and examine its possible association with patients’ demographic and clinical characteristics. Patients and methods This study included adult patients with solid tumours undergoing chemotherapy at the Institute Jules Bordet’s Day Hospital over a ten-day period. EORTC QLQ-C30 and QLQ-INFO25 questionnaires were administered. Demographic and clinical data were collected. Descriptive and inferential statistics were used. Results 101 (99%) fully completed the questionnaires. They were mostly Belgian (74.3%), female (78.2%), with a mean age of 56.9 ± 12.8 years. The most frequent tumour was breast cancer (58.4%). Patients were well-informed about the disease and treatments, but presented unmet information domains. The Jules Bordet patients desired more information on treatment side effects, long-term outcome, nutrition, and recurrence symptoms. Patients on clinical trials reported having received less information about their disease and less written information than patients outside clinical trials. Higher information levels were associated with higher quality of life (QoL) scores and higher patient satisfaction. Conclusion Patients were satisfied with the information they received and this correlated with higher QoL, but they still expressed unmet information wishes. Additional studies are required to investigate the quality of the information received by patients enrolled in clinical trials. PMID:24834120

  4. Impact of Patient Sex on Clinical Outcomes

    PubMed Central

    Teitsma, Xavier M.; van der Hoeven, Henk; Tamminga, Rob; de Bie, Rob A.

    2014-01-01

    Background: The Combined Quality Care Anterior Cruciate Ligament registry provides data for clinical research regarding primary anterior cruciate ligament (ACL) surgery. Purpose: To explore the data with regard to the clinical outcomes between sexes after ACL reconstruction in a Dutch population. Study Design: Cohort study; Level of evidence, 3. Methods: Data involving patients diagnosed with an ACL tear and eligible for surgery were recorded. Isokinetic muscle strength, functional muscle performance, and anterior-posterior translation of the knee joint were documented preoperatively and at 3, 6, 9, and 12 months postoperatively. Patients completed the Knee Injury and Osteoarthritis Outcome Score (KOOS), Lysholm, and Tegner rating scales during each examination using a web-based questionnaire. Results: Approximately 90% of ACL injuries occurred during sport activities. The mean (SD) age at surgery was 28 (11) years for both men and women, and the majority of patients were treated with hamstring tendon autografts (94%). Four percent received bone–patellar tendon–bone autografts, and 2% of the patients received other grafts. Preoperatively, the KOOS, Lysholm, and Tegner scores were significantly higher in males. Twelve months postoperatively, both sexes showed comparable isokinetic strength (P = .336), knee laxity (P = .680), and hop test for distance (P = .122) when comparing the injured with the uninjured side. Self-reported knee function was comparable between sexes as assessed by the KOOS (P = .202), Lysholm (P = .872), and Tegner (P = .767) questionnaires during the 12-month follow-up. Conclusion: One year after ACL surgery, all patients had improved greatly, showing only minor differences between sexes. The male group showed slightly better results when evaluating self-reported knee questionnaires. Comparable outcomes and knee function between sexes can therefore be presumed with patients who are treated with hamstring tendon autografts in a Dutch

  5. Walking Gait Asymmetries Six Months Following Anterior Cruciate Ligament Reconstruction Predict Twelve-Month Patient-Reported Outcomes.

    PubMed

    Pietrosimone, Brian; Blackburn, J Troy; Padua, Darin A; Pfeiffer, Steven J; Davis, Hope C; Luc-Harkey, Brittney A; Harkey, Matthew S; Stanley, Laura E; Frank, Barnett S; Creighton, R Alexander; Kamath, Ganesh M; Spang, Jeffery T

    2018-05-21

    The study sought to determine the association between gait biomechanics (vertical ground reaction force [vGRF], vGRF loading rate [vGRF-LR]) collected six months following anterior cruciate ligament reconstruction (ACLR) with patient-reported outcomes at twelve months following ACLR. Walking gait mechanics and all subsections of the Knee Injury and Osteoarthritis Outcomes Score (KOOS) were collected at six and twelve months following ACLR, respectively, in 25 individuals with a unilateral ACLR. Peak vGRF and peak instantaneous vGRF-LR were extracted from the first 50% of the stance phase. Limb symmetry indices (LSI) were used to normalize outcomes in the ACLR limb to that of the uninjured limb (ACLR /uninjured). Linear regression analyses were used to determine associations between biomechanical outcomes and KOOS while accounting for walking speed. Receiver operator characteristic curves were used to determine the accuracy of 6-month biomechanical outcomes for identifying individuals with acceptable patient-reported outcomes, using previously defined KOOS cut-off scores,12 months post-ACLR. Individuals with lower peak vGRF LSI 6 months post-ACLR demonstrated worse patient-reported outcomes (KOOS Pain, Activities of Daily life, Sport and Recreation, Quality of Life) at the 12-month exam. A peak vGRF LSI ≥0.99 6 months following ACLR associated with 13.33x higher odds of reporting acceptable patient-reported outcomes 12 months post-ACLR. Lesser peak vGRF LSI during walking at 6-months post-ACLR may be a critical indicator of worse future patient-reported outcomes. Achieving early symmetrical lower extremity loading and minimizing under-loading of the ACLR limb during walking may be a potential therapeutic target for improving patient-reported outcomes post-ACLR. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  6. Patient-reported outcomes in adults with congenital heart disease: Inter-country variation, standard of living and healthcare system factors.

    PubMed

    Moons, Philip; Kovacs, Adrienne H; Luyckx, Koen; Thomet, Corina; Budts, Werner; Enomoto, Junko; Sluman, Maayke A; Yang, Hsiao-Ling; Jackson, Jamie L; Khairy, Paul; Cook, Stephen C; Subramanyan, Raghavan; Alday, Luis; Eriksen, Katrine; Dellborg, Mikael; Berghammer, Malin; Johansson, Bengt; Mackie, Andrew S; Menahem, Samuel; Caruana, Maryanne; Veldtman, Gruschen; Soufi, Alexandra; Fernandes, Susan M; White, Kamila; Callus, Edward; Kutty, Shelby; Van Bulck, Liesbet; Apers, Silke

    2018-01-15

    Geographical differences in patient-reported outcomes (PROs) of adults with congenital heart disease (ConHD) have been observed, but are poorly understood. We aimed to: (1) investigate inter-country variation in PROs in adults with ConHD; (2) identify patient-related predictors of PROs; and (3) explore standard of living and healthcare system characteristics as predictors of PROs. Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study (APPROACH-IS) was a cross-sectional, observational study, in which 4028 patients from 15 countries in 5 continents were enrolled. Self-report questionnaires were administered: patient-reported health (12-item Short Form Health Survey; EuroQOL-5D Visual Analog Scale); psychological functioning (Hospital Anxiety and Depression Scale); health behaviors (Health Behavior Scale-Congenital Heart Disease) and quality of life (Linear Analog Scale for quality of life; Satisfaction With Life Scale). A composite PRO score was calculated. Standard of living was expressed as Gross Domestic Product per capita and Human Development Index. Healthcare systems were operationalized as the total health expenditure per capita and the overall health system performance. Substantial inter-country variation in PROs was observed, with Switzerland having the highest composite PRO score (81.0) and India the lowest (71.3). Functional class, age, and unemployment status were patient-related factors that independently and consistently predicted PROs. Standard of living and healthcare system characteristics predicted PROs above and beyond patient characteristics. This international collaboration allowed us to determine that PROs in ConHD vary as a function of patient-related factors as well as the countries in which patients live. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. Perceived Parental Attitudes of Gender Expansiveness: Development and Preliminary Factor Structure of a Self-Report Youth Questionnaire

    PubMed Central

    Hidalgo, Marco A.; Chen, Diane; Garofalo, Robert; Forbes, Catherine

    2017-01-01

    Abstract Purpose: Parental acceptance of gender identity/expression in lesbian, gay, bisexual, transgender, and queer/questioning (LGBTQ+) youth moderates the effects of minority stress on mental health outcomes. Given this association, mental health clinicians of gender-expansive adolescents often assess the degree to which these youth perceive their parents/primary caregivers as accepting or nonaffirming of their gender identity and expression. While existing measures may reliably assess youth's perceptions of general family support, no known tool aids in the assessment an adolescent's perceived parental support related to adolescent gender-expansive experiences. Methods: To provide both clinicians and researchers with an empirically derived tool, the current study used factor analysis to explore an underlying factor structure of a brief questionnaire developed by subject-matter experts and pertaining to multiple aspects of perceived parental support in gender-expansive adolescents and young adults. Respondents were gender-expansive adolescents and young adults seeking care in an interdisciplinary gender-health clinic within a pediatric academic medical center in the Midwestern United States. Results: Exploratory factor analysis resulted in a 14-item questionnaire comprised of two subscales assessing perceived parental nonaffirmation and perceived parental acceptance. Internal consistency and construct validity results provided support for this new questionnaire. Conclusion: This study provides preliminary evidence of the factor structure, reliability and validity of the Parental Attitudes of Gender Expansiveness Scale for Youth (PAGES-Y). These findings demonstrate both the clinical and research utility of the PAGES-Y, a tool that can yield a more nuanced understanding of family-related risk and protective factors in gender-expansive adolescents. PMID:29159312

  8. Perceived Parental Attitudes of Gender Expansiveness: Development and Preliminary Factor Structure of a Self-Report Youth Questionnaire.

    PubMed

    Hidalgo, Marco A; Chen, Diane; Garofalo, Robert; Forbes, Catherine

    2017-01-01

    Purpose: Parental acceptance of gender identity/expression in lesbian, gay, bisexual, transgender, and queer/questioning (LGBTQ+) youth moderates the effects of minority stress on mental health outcomes. Given this association, mental health clinicians of gender-expansive adolescents often assess the degree to which these youth perceive their parents/primary caregivers as accepting or nonaffirming of their gender identity and expression. While existing measures may reliably assess youth's perceptions of general family support, no known tool aids in the assessment an adolescent's perceived parental support related to adolescent gender-expansive experiences. Methods: To provide both clinicians and researchers with an empirically derived tool, the current study used factor analysis to explore an underlying factor structure of a brief questionnaire developed by subject-matter experts and pertaining to multiple aspects of perceived parental support in gender-expansive adolescents and young adults. Respondents were gender-expansive adolescents and young adults seeking care in an interdisciplinary gender-health clinic within a pediatric academic medical center in the Midwestern United States. Results: Exploratory factor analysis resulted in a 14-item questionnaire comprised of two subscales assessing perceived parental nonaffirmation and perceived parental acceptance. Internal consistency and construct validity results provided support for this new questionnaire. Conclusion: This study provides preliminary evidence of the factor structure, reliability and validity of the Parental Attitudes of Gender Expansiveness Scale for Youth (PAGES-Y). These findings demonstrate both the clinical and research utility of the PAGES-Y, a tool that can yield a more nuanced understanding of family-related risk and protective factors in gender-expansive adolescents.

  9. Patient-reported quality of life outcomes for children with serious congenital heart defects.

    PubMed

    Knowles, Rachel L; Day, Thomas; Wade, Angie; Bull, Catherine; Wren, Christopher; Dezateux, Carol

    2014-05-01

    To compare patient-reported, health-related quality of life (QoL) for children with serious congenital heart defects (CHDs) and unaffected classmates and to investigate the demographic and clinical factors influencing QoL. Retrospective cohort study. UK National Health Service. UK-wide cohort of children with serious CHDs aged 10-14 years requiring cardiac intervention in the first year of life in one of 17 UK paediatric cardiac surgical centres operating during 1992-1995. A comparison group of classmates of similar age and sex was recruited. Child self-report of health-related QoL scores (Pediatric Quality of Life Inventory, PedsQL) and parental report of schooling and social activities. Questionnaires were completed by 477 children with CHDs (56% boys; mean age 12.1 (SD 1.0) years) and 464 classmates (55%; 12.0 (SD 1.1) years). Children with CHDs rated QoL significantly lower than classmates (CHDs: median 78.3 (IQR 65.0-88.6); classmates: 88.0 (80.2-94.6)) and scored lower on physical (CHDs: 84.4; classmates: 93.8; difference 9.4 (7.8 to 10.9)) and psychosocial functioning subscales (CHDs: 76.7, classmates: 85.0; difference 8.3 (6.0 to 10.6)). Cardiac interventions, school absence, regular medications and non-cardiac comorbidities were independently associated with reduced QoL. Participation in sport positively influenced QoL and was associated with higher psychosocial functioning scores. Children with serious CHDs experience lower QoL than unaffected classmates. This appears related to the burden of clinical intervention rather than underlying cardiac diagnosis. Participation in sports activities is positively associated with increased emotional well-being. Child self-report measures of QoL would be a valuable addition to clinical outcome audit in this age group.

  10. Prevalence of swallowing and speech problems in daily life after chemoradiation for head and neck cancer based on cut-off scores of the patient-reported outcome measures SWAL-QOL and SHI.

    PubMed

    Rinkel, Rico N; Verdonck-de Leeuw, Irma M; Doornaert, Patricia; Buter, Jan; de Bree, Remco; Langendijk, Johannes A; Aaronson, Neil K; Leemans, C René

    2016-07-01

    The objective of this study is to assess swallowing and speech outcome after chemoradiation therapy for head and neck cancer, based on the patient-reported outcome measures Swallowing Quality of Life Questionnaire (SWAL-QOL) and Speech Handicap Index (SHI), both provided with cut-off scores. This is a cross-sectional study. Department of Otolaryngology/Head and Neck Surgery of a University Medical Center. Sixty patients, 6 months to 5 years after chemoradiation for head and neck squamous cell carcinoma. Swallowing Quality of Life Questionnaire (SWAL-QOL) and SHI, both validated in Dutch and provided with cut-off scores. Associations were tested between the outcome measures and independent variables (age, gender, tumor stage and site, and radiotherapy technique, time since treatment, comorbidity and food intake). Fifty-two patients returned the SWAL-QOL and 47 the SHI (response rate 87 and 78 %, respectively). Swallowing and speech problems were present in 79 and 55 %, respectively. Normal food intake was noticed in 45, 35 % had a soft diet and 20 % tube feeding. Patients with soft diet and tube feeding reported more swallowing problems compared to patients with normal oral intake. Tumor subsite was significantly associated with swallowing outcome (less problems in larynx/hypopharynx compared to oral/oropharynx). Radiation technique was significantly associated with psychosocial speech problems (less problems in patients treated with IMRT). Swallowing and (to a lesser extent) speech problems in daily life are frequently present after chemoradiation therapy for head and neck cancer. Future prospective studies will give more insight into the course of speech and swallowing problems after chemoradiation and into efficacy of new radiation techniques and swallowing and speech rehabilitation programs.

  11. Validation of birth outcomes from the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS): population-based analysis from the Massachusetts Outcome Study of Assisted Reproductive Technology (MOSART).

    PubMed

    Stern, Judy E; Gopal, Daksha; Liberman, Rebecca F; Anderka, Marlene; Kotelchuck, Milton; Luke, Barbara

    2016-09-01

    To assess the validity of outcome data reported to the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) compared with data from vital records and the birth defects registry in Massachusetts. Longitudinal cohort. Not applicable. A total of 342,035 live births and fetal deaths from Massachusetts mothers giving birth in the state from July 1, 2004, to December 31, 2008; 9,092 births and fetal deaths were from mothers who had conceived with the use of assisted reproductive technology (ART) and whose cycle data had been reported to the SART CORS. Not applicable. Percentage agreement between maternal race and ethnicity, delivery outcome (live birth or fetal death), plurality (singleton, twin, or triplet+), delivery date, and singleton birth weight reported in the SART CORS versus vital records; sensitivity and specificity for birth defects among singletons as reported in the SART CORS versus the Massachusetts Birth Defects Monitoring Program (BDMP). There was >95% agreement between the SART CORS and vital records for fields of maternal race/ethnicity, live birth/fetal death, and plurality; birth outcome date was within 1 day with 94.9% agreement and birth weight was within 100 g with 89.6% agreement. In contrast, sensitivity for report of any birth defect was 38.6%, with a range of 18.4%-50.0%, for specific birth defect categories. Although most SART CORS outcome fields are accurately reported, birth defect variables showed poor sensitivity compared with the gold standard data from the BDMP. We suggest that reporting of birth defects be discontinued. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  12. Endoscopy-assisted surgery for the management of benign breast tumors: technique, learning curve, and patient-reported outcome from preliminary 323 procedures.

    PubMed

    Lai, Hung-Wen; Lin, Hui-Yu; Chen, Shu-Ling; Chen, Shou-Tung; Chen, Dar-Ren; Kuo, Shou-Jen

    2017-01-11

    Endoscopy-assisted breast surgery (EABS), a technique that optimizes cosmetic outcome because it is performed through small wounds hidden in inconspicuous areas, could be an alternative surgical technique for benign breast tumors. In this study, we report the preliminary results of 323 EABS procedures performed at our institution for the management of benign breast tumors. The medical records of patients who underwent EABS for benign breast lesions during the periods August 2010 to December 2015 were collected from the Changhua Christian Hospital EABS database. Data on clinicopathologic characteristics, type of surgery, hospital stay, and complications were analyzed to determine the effectiveness of the procedure for benign breast tumors. The operating time with the number of procedure performed was analyzed for learning curve evaluation. Patient satisfaction with cosmetic outcome was evaluated with a self-report questionnaire. A total of 323 EABS procedures were performed in 286 patients with benign breast lesions, including 249 (90.5%) patients with unilateral lesions. The mean age was 36 years, the mean tumor size was 2.2 cm, and the mean distance from the nipple to the tumor was 5.2 cm. Most (93.8%, 303/323) of these tumors were excised through a transareolar wound, 2.4% (8/323) through an axillary wound, and 0.3% (1/323) through the infra-mammary fold. Histopathologic analysis revealed that 63.5% (202/318) of the tumors were fibroadenoma-related lesions. The mean operative time was 81.4 min (59~89 min), which was decreased with experience increased. The overall rate of complications was 6.5%, and all were minor and wound-related. Among the 110 patients who participated in the self-report cosmetic outcome evaluation, 85.4% reported being satisfied with the cosmetic result, and almost all were satisfied with breast symmetry. Of the patients interviewed, 92.7% reported that they would choose the same procedure if they had to undergo the operation again. Our

  13. Screening for depression in arthritis populations: an assessment of differential item functioning in three self-reported questionnaires.

    PubMed

    Hu, Jinxiang; Ward, Michael M

    2017-09-01

    To determine if persons with arthritis differ systematically from persons without arthritis in how they respond to questions on three depression questionnaires, which include somatic items such as fatigue and sleep disturbance. We extracted data on the Centers for Epidemiological Studies Depression (CES-D) scale, the Patient Health Questionnaire-9 (PHQ-9), and the Kessler-6 (K-6) scale from three large population-based national surveys. We assessed items on these questionnaires for differential item functioning (DIF) between persons with and without self-reported physician-diagnosed arthritis using multiple indicator multiple cause models, which controlled for the underlying level of depression and important confounders. We also examined if DIF by arthritis status was similar between women and men. Although five items of the CES-D, one item of the PHQ-9, and five items of the K-6 scale had evidence of DIF based on statistical comparisons, the magnitude of each difference was less than the threshold of a small effect. The statistical differences were a function of the very large sample sizes in the surveys. Effect sizes for DIF were similar between women and men except for two items on the Patient Health Questionnaire-9. For each questionnaire, DIF accounted for 8% or less of the arthritis-depression association, and excluding items with DIF did not reduce the difference in depression scores between those with and without arthritis. Persons with arthritis respond to items on the CES-D, PHQ-9, and K-6 depression scales similarly to persons without arthritis, despite the inclusion of somatic items in these scales.

  14. 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…

  15. Tuberculosis treatment outcome monitoring in England, Wales and Northern Ireland for cases reported in 2001

    PubMed Central

    Antoine, Delphine; French, Clare E; Jones, Jane; Watson, John M

    2007-01-01

    Background Tuberculosis treatment outcome monitoring was introduced in England, Wales and Northern Ireland in 2002 based on cases reported in 2001. Objective To estimate the proportion of treatment success and to identify predictors of non‐completion for cases reported in 2001. Method At 12 months after the start of treatment, outcome was assessed according to a protocol based on standardised European recommendations. Results The proportion of cases completing treatment by 12 months was 79% if calculated for cases in whom outcome information was reported, and 62% of all cases regardless of whether information on outcome was reported or not. Of the new smear‐positive pulmonary cases for whom information on outcome was reported, 77% completed treatment. Non‐completion of treatment was associated with male sex, age ⩾65 years, recent entry into UK for those born abroad, residence outside London, pulmonary disease and drug resistance. Conclusions Despite the resources of an industrialised country with a low incidence of tuberculosis, the World Health Organization treatment success target of 85% was not achieved. This was partly due to the number of deaths in the elderly, and partly due to missing outcome information for 21% of the cases. As in other low‐incidence countries, additional outcome measures such as the proportion of those aged <65 years completing treatment would provide a more comparable indicator for assessment of treatment success. This first year of data collection has shown the importance of increasing the proportion of cases for whom outcome is ascertained, and of ensuring the validity of information provided. PMID:17372289

  16. 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

  17. Correlation of Patient-Reported Outcomes Measurement Information System (PROMIS) scores with legacy patient-reported outcome scores in patients undergoing rotator cuff repair.

    PubMed

    Patterson, Brendan M; Orvets, Nathan D; Aleem, Alexander W; Keener, Jay D; Calfee, Ryan P; Nixon, Devon C; Chamberlain, Aaron M

    2018-06-01

    The Patient-Reported Outcomes Measurement Information System (PROMIS) is being used to assess outcomes in many patient populations despite limited validation. The purpose of this study was to investigate the relationship between American Shoulder and Elbow Surgeons (ASES) and Simple Shoulder Test (SST) scores and PROMIS Physical Function (PF) and Upper Extremity (UE) function scores collected preoperatively in patients undergoing rotator cuff repair. This cross-sectional study analyzed 164 consecutive patients undergoing arthroscopic rotator cuff repair. Study inclusion required preoperative completion of the ASES and SST evaluations, as well as the PROMIS PF, UE, and Pain Interference computerized adaptive tests. Descriptive statistics were produced, and Pearson correlation coefficients were calculated between each of the outcome measures. Average PROMIS UE scores indicated greater impairment than PROMIS PF scores (34 vs 44). Three percent of patients reached the PROMIS UE ceiling score of 56. PROMIS PF scores demonstrated a weak correlation with ASES scores (r = 0.43, P < .001) and a moderate correlation with SST scores (r = 0.51, P < .001). PROMIS UE scores demonstrated a moderate correlation with both ASES scores (r = 0.59, P < .001) and SST scores (r = 0.62, P < .001). PROMIS Pain Interference scores demonstrated weak negative correlations with both ASES scores (r = -0.43, P < .001) and SST scores (r = -0.41, P < .001). Patients answered fewer questions on average using the PROMIS PF and UE instruments as compared with the ASES and SST instruments. PROMIS UE scores indicate greater impairment and demonstrate a stronger correlation with the legacy shoulder scores than PROMIS PF scores in patients with symptomatic rotator cuff tears. PROMIS computerized adaptive tests allow for more efficient patient-reported outcome data collection compared with traditional outcome scores. Copyright © 2018 Journal of Shoulder and

  18. Comparison of Registered and Reported Outcomes in Randomized Clinical Trials Published in Anesthesiology Journals.

    PubMed

    Jones, Philip M; Chow, Jeffrey T Y; Arango, Miguel F; Fridfinnson, Jason A; Gai, Nan; Lam, Kevin; Turkstra, Timothy P

    2017-10-01

    Randomized clinical trials (RCTs) provide high-quality evidence for clinical decision-making. Trial registration is one of the many tools used to improve the reporting of RCTs by reducing publication bias and selective outcome reporting bias. The purpose of our study is to examine whether RCTs published in the top 6 general anesthesiology journals were adequately registered and whether the reported primary and secondary outcomes corresponded to the originally registered outcomes. Following a prespecified protocol, an electronic database was used to systematically screen and extract data from RCTs published in the top 6 general anesthesiology journals by impact factor (Anaesthesia, Anesthesia & Analgesia, Anesthesiology, British Journal of Anaesthesia, Canadian Journal of Anesthesia, and European Journal of Anaesthesiology) during the years 2007, 2010, 2013, and 2015. A manual search of each journal's Table of Contents was performed (in duplicate) to identify eligible RCTs. An adequately registered trial was defined as being registered in a publicly available trials registry before the first patient being enrolled with an unambiguously defined primary outcome. For adequately registered trials, the outcomes registered in the trial registry were compared with the outcomes reported in the article, with outcome discrepancies documented and analyzed by the type of discrepancy. During the 4 years studied, there were 860 RCTs identified, with 102 RCTs determined to be adequately registered (12%). The proportion of adequately registered trials increased over time, with 38% of RCTs being adequately registered in 2015. The most common reason in 2015 for inadequate registration was registering the RCT after the first patient had already been enrolled. Among adequately registered trials, 92% had at least 1 primary or secondary outcome discrepancy. In 2015, 42% of RCTs had at least 1 primary outcome discrepancy, while 90% of RCTs had at least 1 secondary outcome discrepancy

  19. Validation of the COURAGE Built Environment Self-Reported Questionnaire.

    PubMed

    Raggi, Alberto; Quintas, Rui; Bucciarelli, Paola; Franco, Maria Grazia; Andreotti, Alessandra; Miret, Marta; Zawisza, Katarzyna; Olaya, Beatriz; Chatterji, Somnath; Sainio, Päivi; Frisoni, Giovanni Battista; Martinuzzi, Andrea; Minicuci, Nadia; Power, Mick; Leonardi, Matilde

    2014-01-01

    The built environment (BE) impacts on people's disability and health, in terms of overweight, depression, alcohol abuse, poor self-rated health and presence of psychological symptoms; it is reasonable to assume that BE also impacts on participation levels. This paper presents the validation of the COURAGE Built Environment Self-Reported Questionnaire (CBE-SR), an instrument designed to evaluate BE in the context of health and disability. Subjects participating to COURAGE, a cross-sectional study conducted on 10,800 citizens of Poland, Finland and Spain, completed a protocol inclusive of the CBE-SR. Psychometric properties and factor structure were analysed, and factor scores created. Gender differences, differences between persons from different age groups and persons reporting the environment as facilitating, hindering or neutral were calculated. Eight items were deleted so that the final version of CBE-SR comprises 19 items. Cronbach's alpha ranged from 0.743 to 0.906, and test-retest stability was demonstrated for the majority of items. Four subscales were identified: Usability of the neighbourhood environment; Hindrance of walkable environment; Easiness of use of public buildings, places and facilities; and Risk of accidents and usability of the living place. Younger respondents reported their neighbourhood as more usable but perceived walkways as more hindering and public buildings as less easy to use; gender differences were almost inexistent. The CBE-SR is a four-scale instrument with good psychometric properties that measures the person-environment interaction. It is sensitive across age groups and is consistent with the subject's overall judgement of the degree to which the environment is facilitating or hindering. Poor built environments have a negative impact on the level of a person's participation. However, instruments measuring the person-environment interaction are lacking. The CBE-SR is a valid and reliable instrument that researchers can use to

  20. Sexual function and quality of life in genitourinary medicine (GUM) outpatients and preliminary validation of a self-report questionnaire measure.

    PubMed

    Daker-White, Gavin; Crowley, Tessa

    2003-05-01

    A cross-sectional questionnaire survey of 216 men and 191 women attending a genitourinary medicine (GUM) clinic was undertaken to explore the relationship between sexual symptoms and quality of sexual life, and to test the psychometric validity of a pilot self-report measure of Sexual Function and Quality of Sexual Life (SFQoSL). Statistical comparisons were made with three reference groups: volunteers attending GUM for psychosexual counselling, outpatients at an Obstetrics and Gynaecology Department, and staff. Exploratory principal components analysis (with varimax rotation) of questionnaire item responses suggested an 11 (in women) and 13 (in men) factor solution, incorporating four multi-item scales. Internal consistency (Cronbach's alpha) of core items was 0.84 in 186 women (19 items) and 0.87 in 210 men (22 items). Construct validity was supported in comparisons with reference groups using one-way analysis of variance and post-hoc Scheffé testing. Overall, 116 (54%) male and 132 (69%) female GUM outpatients had scores indicating sexual dysfunction. Thirty-seven (17%) men reported erectile dysfunction; 54 (28%) women reported vaginal dryness affecting sex; 48 (25%) women reported genital changes affecting sex; 45 (21%) men and 64 (34%) women reported problems reaching orgasm.